Invivo RM9311N12 REMOTE CONTROL TRANSMITTER User Manual 9567

Invivo Corporation REMOTE CONTROL TRANSMITTER 9567

USERS MANUAL

Invivo Corporation3160 MRI PHYSIOLOGICAL MONITORING SYSTEMOPERATIONS MANUAL
iTABLE OF CONTENTSParagraph Number Page NumberList of Figures ........................................................................................................................................... ivList of Tables.............................................................................................................................................. vEquipment Classification ........................................................................................................................ vPrecautions ................................................................................................................................................ viUser Responsibility ................................................................................................................................xiv3160 MRI Physiological Monitor Accessories.................................................................................. xv1.0 INTRODUCTION ......................................................................................................... 1-11.1 Product Description ......................................................................................................... 1-11.1.1 System Mounting................................................................................................. 1-11.1.2 System Parameters............................................................................................... 1-11.1.3 User Interface....................................................................................................... 1-21.1.4 Versatility............................................................................................................. 1-21.2 Wireless Processor Unit (WPU) ...................................................................................... 1-21.2.1 Operating Environment........................................................................................ 1-21.2.2 Power Supply....................................................................................................... 1-21.2.3 Battery Operation................................................................................................. 1-21.3 Patient Connections ......................................................................................................... 1-21.3.1 NIBP and Agent Monitoring................................................................................ 1-21.3.2 ECG Monitoring .................................................................................................. 1-31.3.3 SpO2 Monitoring ................................................................................................. 1-31.4 Display Control Unit (DCU)............................................................................................ 1-31.4.1 DCU Controls ...................................................................................................... 1-31.4.2 DCU Display........................................................................................................ 1-81.5 Cleaning ......................................................................................................................... 1-121.5.1 Cleaning Accessories......................................................................................... 1-122.0 INSTALLATION........................................................................................................... 2-12.1 Introduction...................................................................................................................... 2-12.2 Monitor Installation ......................................................................................................... 2-12.2.1 Monitor Mounting................................................................................................ 2-12.2.2 Preparing the 3160 MRI Physiological Monitoring System for Use................... 2-12.2.3 Monitor Start Up.................................................................................................. 2-13.0 PREPARATION FOR USE.......................................................................................... 3-13.1 Introduction...................................................................................................................... 3-13.2 SETUPS Menu................................................................................................................. 3-13.3 Store/Recall Setups ........................................................................................................ 3-203.4 Monitor Initialization..................................................................................................... 3-213.4.1 Default Initialization .......................................................................................... 3-213.4.2 Pre-Configured Initialization ............................................................................. 3-214.0 PATIENT PARAMETERS........................................................................................... 4-14.1 ECG Monitoring .............................................................................................................. 4-14.1.1 Patient and Lead Preparation ............................................................................... 4-14.1.2 Associated Waveforms and Displays .................................................................. 4-24.1.3 The ECG Menu.................................................................................................... 4-24.1.4 Alarm Limits........................................................................................................ 4-54.1.5 Trended Data........................................................................................................ 4-54.1.6 ECG Messages..................................................................................................... 4-5
iiTABLE OF CONTENTSParagraph Number Page Number4.2 Non-Invasive Blood Pressure (NIBP) Monitoring .......................................................... 4-54.2.1 Theory of Oscillometric Measurement ................................................................ 4-64.2.2 Patient and Cuff Preparation................................................................................ 4-74.2.3 Associated Displays............................................................................................. 4-74.2.4 The NIBP Menu................................................................................................... 4-94.2.5 NIBP Menu Options ............................................................................................ 4-94.2.6 Using the Automatic Interval Mode .................................................................. 4-114.2.7 Manually Starting/Stopping a Reading Cycle ................................................... 4-114.2.8 Stat Mode Operation.......................................................................................... 4-114.2.9 Alarm Limits...................................................................................................... 4-114.2.10 Adult vs. Neonatal Mode Operation .................................................................. 4-114.2.11 Trended Data...................................................................................................... 4-114.2.12 NIBP Messages.................................................................................................. 4-124.3 SpO2 Monitoring ........................................................................................................... 4-124.3.1 Sensor Positioning ............................................................................................. 4-124.3.2 Associated Waveforms and Displays ................................................................ 4-134.3.3 SpO2 Menu ........................................................................................................ 4-134.3.4 Alarm Limits...................................................................................................... 4-144.3.5 Trended Data...................................................................................................... 4-144.3.6 SpO2 Messages.................................................................................................. 4-144.4 End-tidal CO2 (EtCO2) Monitoring .............................................................................. 4-154.4.1 Patient and Sampling Line Preparation ............................................................. 4-154.4.2 Water Trap Replacement ................................................................................... 4-174.4.3 Associated Waveforms and Displays ................................................................ 4-174.4.4 EtCO2 Menu ...................................................................................................... 4-184.4.5 Calibration of CO2/N2O Measurement System ................................................ 4-184.4.6 Alarm Limits...................................................................................................... 4-194.4.7 Trended Data...................................................................................................... 4-194.4.8 EtCO2 Messages................................................................................................ 4-194.5 Anesthetic Agent/Oxygen Monitoring........................................................................... 4-204.5.1 Patient and Tubing Preparation.......................................................................... 4-204.5.2 Associated Displays........................................................................................... 4-214.5.3 Agent Menu ....................................................................................................... 4-234.5.4 Gas Calibration .................................................................................................. 4-234.5.5 Alarm Limits...................................................................................................... 4-244.5.6 Trended Data...................................................................................................... 4-244.5.7 Agent/O2 Messages ........................................................................................... 4-244.5.8 Oxygen Monitoring............................................................................................ 4-255.0 RECORDING AND TRENDING ................................................................................ 5-15.1 Introduction...................................................................................................................... 5-15.1.1 Record Key .......................................................................................................... 5-15.2 The RECORDER Menu................................................................................................... 5-1
iiiTABLE OF CONTENTSParagraph Number Page Number5.3 Recording Charts ............................................................................................................. 5-35.3.1 Strip Chart Record ............................................................................................... 5-45.3.2 Tabular Chart Record........................................................................................... 5-45.3.3 Trend Chart .......................................................................................................... 5-55.3.4 System Data Report ............................................................................................. 5-55.4 Loading Recorder Paper .................................................................................................. 5-55.5 Trending Feature.............................................................................................................. 5-55.5.1 HISTORY Menu Options .................................................................................... 5-66.0 ALARMS ........................................................................................................................ 6-16.1 Introduction...................................................................................................................... 6-16.2 Alarm Limits.................................................................................................................... 6-16.2.1 Default (Pre-Set) Alarm Limits ........................................................................... 6-16.2.2 Range of High and Low Alarm Limits ................................................................ 6-16.3 Alarm Setup ..................................................................................................................... 6-16.3.1 Parameter Alarms Status Screen.......................................................................... 6-46.4 Turning Alarms Off on Individual Parameters ................................................................ 6-46.5 Alarm Violations.............................................................................................................. 6-46.6 Adjusting the Alarm Tone Volume ................................................................................. 6-56.6.1 Disabling the Alarm Tone.................................................................................... 6-56.7 Standby Mode .................................................................................................................. 6-67.0 BATTERY OPERATION............................................................................................. 7-17.1 Introduction...................................................................................................................... 7-17.2 Battery Location and Access ........................................................................................... 7-17.3 Loading and Unloading Battery(s) .................................................................................. 7-17.4 Battery Charging.............................................................................................................. 7-17.5 Battery Operation Time ................................................................................................... 7-17.5.1 Battery Low Indication ........................................................................................ 7-17.6 Battery Replacement........................................................................................................ 7-1Specifications............................................................................................................................. A-1Repair..........................................................................................................................................B-1Warranty ....................................................................................................................................C-1Declaration of Conformity ....................................................................................................... D-1kPa to mmHg Conversion Chart ..............................................................................................E-1List of Symbols ........................................................................................................................... F-1
ivLIST OF FIGURESFigure Number Page Number1-1 Patient Connection Unit (PCU) ....................................................................................... 1-21-2 The Front Panel................................................................................................................ 1-31-3 The Top Keypad Set ........................................................................................................ 1-41-4 The Middle Keypad Set ................................................................................................... 1-51-5 The Bottom Keypad Set................................................................................................... 1-61-6 The Normal Screen .......................................................................................................... 1-81-7 The Informational Display............................................................................................... 1-81-8 The Vital Signs Trace Display......................................................................................... 1-91-9 The Vital Signs Numeric Display.................................................................................. 1-103-1 The DCU SETUPS Menu ................................................................................................ 3-13-2 The RECALL SETUPS Menu......................................................................................... 3-23-3 The STORE SETUPS Menu............................................................................................ 3-33-4 The PARAMETER SELECTION Menu......................................................................... 3-43-5 The SOUND ADJUST Menu .......................................................................................... 3-53-6 The SET TIME Menu ...................................................................................................... 3-73-7 NETWORK Menu ........................................................................................................... 3-83-8 The DCU SERVICE (BIO-MED) Menu ......................................................................... 3-83-9 The SYSTEM CONFIG Menu ........................................................................................ 3-93-10 WPU SETUPS Menu..................................................................................................... 3-113-11 The PARAMETER SELECTION Menu....................................................................... 3-113-12 The SOUND ADJUST Menu ........................................................................................ 3-133-13 The SET TIME Menu .................................................................................................... 3-143-14 The WPU SERVICE (BIO-MED) Menu....................................................................... 3-153-15 NIBP TESTS Menu ....................................................................................................... 3-163-16 GAS CAL Menu ............................................................................................................ 3-173-17 Monitor Calibration YES/NO Menu.............................................................................. 3-183-18 Monitor Calibration Information Screen ....................................................................... 3-183-19 System Configuration Menu.......................................................................................... 3-194-1 ECG Trace and Numerical Displays................................................................................ 4-14-2 The ECG Menu................................................................................................................ 4-24-3 The ECG SCALE Sub-Menu........................................................................................... 4-34-4 The ECG HR SOURCE Sub-Menu ................................................................................. 4-44-5 Oscillometric Measurement Method ............................................................................... 4-64-6 The NIBP Display............................................................................................................ 4-74-7 The NIBP Menu............................................................................................................... 4-84-8 The NIBP INTERVAL Menu.......................................................................................... 4-94-9 The HISTORY Menu..................................................................................................... 4-104-10 SpO2 Display................................................................................................................. 4-134-11 The SpO2 Menu............................................................................................................. 4-134-12 The SpO2 SIZE Menu ................................................................................................... 4-144-13 The Patient Sampling Circuit......................................................................................... 4-164-14 Water Trap Installation Diagram ................................................................................... 4-164-15 The EtCO2 Display........................................................................................................ 4-174-16 The EtCO2 Menu........................................................................................................... 4-184-17 Anesthetic Agents Display............................................................................................. 4-205-1 The RECORDER Menu................................................................................................... 5-2
vLIST OF FIGURESFigure Number Page Number5-2 Sample Strip Chart........................................................................................................... 5-45-3 Sample Tabular Chart ...................................................................................................... 5-45-4 System Data Report ......................................................................................................... 5-55-5 Loading the Recorder Paper ............................................................................................ 5-55-6 The HISTORY Menu....................................................................................................... 5-65-7 The MULTI TRENDS Menu........................................................................................... 5-75-8 The Trend SELECT Menu............................................................................................... 5-75-9 Sample Multi Trends Printout.......................................................................................... 5-86-1 The ALARMS Menu ....................................................................................................... 6-16-2 GAS ALARMS (Anesthetic Agents Alarm Limit) Menu ............................................... 6-3LIST OF TABLESTable Number Page Number4-1 Agent Display During Mixed Agent Conditions ........................................................... 4-224-2 Agent Display During Mixed Agent Conditions .......................................................... 4-236-1 Alarm Limit Factory Default Settings ............................................................................. 6-76-2 Range of Alarm Limits .................................................................................................... 6-8EQUIPMENT CLASSIFICATIONClassification according to IEC-60601-1According to the type of protection against electrical shock:Class I equipment.According to the degree of protection against electrical shock:Type CF (defibrillator-proof) equipment.According to the degree of protection against harmful ingress of water:Ordinary equipment (enclosed equipment without protection against ingress of water).According to the methods of sterilization or disinfection:Non-sterilizable. Use of liquid surface disinfectants only.According to the mode of operation: Continuous operation.Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.
viPrecautionsGeneralFederal law in the USA or Canada restricts this device to sale by, or on, the order of a physician.The accuracy of the measurements can be affected by the position of the patient, the patient’sphysiological condition, and other factors. Always consult a physician for interpretation ofmeasurements made by this monitor.To avoid monitor fall, secure monitor on the shelf or bracket prior to use.An explosion hazard exists if this monitor is used in the presence of flammable anesthetics.The operator should read and thoroughly understand this manual completely before attempting tooperate the 3160 MRI Physiological Monitoring System.If any system failure occurs (e.g. an unexplained continuous audible alarm) remove the monitorfrom use, and refer it to qualified service personnel.When an “X” appears in the Alarm Bell symbol, the audible alarm tone will not sound for anyreason.Perform operational checkout before each use. If monitor fails to function properly, refer toqualified service personnel.For safe and accurate operation, use only recommended Invivo patient cable, lead wires, cuffs,hoses, sensors, tubing, etc. A listing of these can be found in the Accessory Listing within thismanual, or by contacting Invivo directly.For continued operation, always connect the monitor to AC Main Power when a Low Batteryindication occurs. Failure to do this can lead to interruption of monitoring and/or damage to themonitor’s battery(s).The system may not conform to all performance specifications if stored or used outside theenvironmental specifications identified in Appendix A in the rear of this manual.Do not apply any unnecessary pressure to the screen area of the monitor. Severe pressure appliedto this portion of the monitor could result in damage or failure of this screen.All equipment not complying with IEC 60601-1 should be placed outside the patientenvironment. Only connect IEC 60601-1 compliant equipment to this monitor. To avoidpotentially hazardous leakage currents, always check the summation of leakage currents whenseveral items of equipment are interconnected.For proper equipment maintenance, perform the service procedures at the recommended intervalsas described in the monitor’s service manual.Single use devices should never be reused.Organic vapors (e.g. from cleaning agents) in sampling line or room air may alter anesthetic agentreadings.Alcohol in patient's breath may modify the anesthetic agent readings.
viiPrecautionsElectrical SafetyTo avoid an electrical hazard, never immerse the unit in any fluid or attempt to clean it with liquidcleaning agents. Always disconnect monitor from AC Main Power before performing cleaning ormaintenance.If monitor becomes accidentally wet during use, discontinue operation of the monitor until allaffected components have been cleaned and permitted to dry completely. Contact your localInvivo representative if additional information is required.Shock hazard exists if operated without chassis cover. Refer servicing to qualified servicepersonnel only.For continued protection against fire hazard, replace fuses with same type and rating only.Connect the monitor only to a three-wire, grounded, hospital-grade receptacle. The three-conductor plug must be inserted into a properly wired three-wire receptacle; if a three-wirereceptacle is not available, a qualified electrician must install one in accordance with thegoverning electrical code.Do not under any circumstances remove the grounding conductor from the power plug.Avoid use of electrical power extension cords. Electrical power extension cords may create asafety hazard by compromising the grounding integrity of the monitor.None of the monitor interconnection ports on the rear of the monitor (e.g. Communication Ports,Auxiliary Input/Output port [AUX I/O], ECG Sync Input [ECG SYNC IN], Keyboard or VideoInput) are intended for direct patient connection. An electric shock hazard can exist if the patientis electrically connected to any of these connections.This monitor and its listed accessories may be safely powered by the voltages 110-120/220-240VAC having a frequency of 50 or 60 Hz.If the integrity of the earth ground conductor of the AC mains power cable is in doubt, operate themonitor on internal battery power until proper earth ground connection is confirmed.Patient SafetyConstant attention by a qualified individual is needed whenever a patient is under anesthesia orconnected to a ventilator. Some equipment malfunctions may occur in spite of equipment ormonitor alarms.Always test sampling line adapter for a tight connection and proper operation before attaching toa patient.As with all medical equipment, carefully route patient cabling to reduce the possibility of patiententanglement or strangulation.Occupational SafetyConnect the sample gas outlet on the monitor's rear panel to a scavenging system to preventpollution of room air.Handle the Patient Sampling Line and its contents as you would any body fluid. Infectious hazardmay be present.MRI Use PrecautionsCertain components of this device will be affected by the magnetic and radio frequency fields presentin your MRI System. Confer with your MRI physicist and/or Radiology staff to identify the properplacement and use areas for the monitor and its accessories, as defined on the monitor or accessorylabeling. Failure to properly place the monitor and its accessories in the Magnet Room will result inmonitor failure, and possible patient or user injury. Always position the 3160 MRI PhysiologicalMonitoring System at, or outside, the 5000 Gauss (0.5T) field line of the MRI system. A slightdistortion of the MRI magnetic field homogeneity or possible damage to either the monitor's NIBP orEtCO2 pump could occur.
viiiPrecautionsMRI Use Precautions (Continued)Always verify proper communicationof the 3160 MRI Physiological Monitoring System withthe Remote Monitor prior to patient use.MRI Magnet Room Placement. The 3160 MRI Physiological Monitoring System is designed to beused in conjunction with a remote monitor. The 3160 MRI Physiological Monitoring System isspecially designed not to interfere with MRI operations and may be used inside the MRI Magnet Roomin any location at or outside the 5000 Gauss (0.5T) Field Line of the MRI System. If brought closerthan the 5000 Gauss Field Line, the NIBP monitor pump and EtCO2 pump may fail to operate.The Remote Monitor is also specifically designed not to interfere with MRI operations, and may beused in the Magnet Room at or outside the 1000 Gauss (0.1T) Field Line of the MRI System. Ifbrought closer than the 1000 Gauss Field Line, monitor damage (failure to operate) may result.Risk of RF current burn. Cables which become inadvertently looped during MRI act as conductivelines for RF induced currents. When lead wires or other cables form a conductive loop in contact withthe patient's tissue, minor to severe burning can result.Perform the following to minimize risk of RF current burn:a. Place cables and lead wires neatly in straight alignment with no looping.b. Keep the length of lead wires and patient cable within the bore to a minimum.c. RF burn risk increases when multiple sensors/cables are in use. Such combinations arenot recommended.d. The high radio frequency (RF) power used in MRI scanning poses an ever-present riskof excessive heat at the monitoring sites and, therefore, the risk of RF current burn.Should power levels greater than S.A.R. of 4 w/kg peak (0.4 w/kg average) beused, the risk of patient burn greatly increases. As a result, monitoring of ECG atpower levels of greater than 4 w/kg peak (0.4 w/kg average) is not recommended forthe general patient population. Such monitoring should only be attempted on consciouspatients with good temperature reflex so they may warn the operator of excessive heatat the monitoring sites.e. High RF Power may cause patient heating or burns. For scans with average S.A.R. > 1w/kg, limit scan time to 5 minutes and pause at least 3 minutes between scans to allowECG Cable to cool.MRI CompatibilityThe Quadtrode® MRI ECG Electrode Pad, and ECG Patient Lead Wires and Cable, are compatiblewith Magnetic Resonance Imaging (MRI) Systems within the following guidelines:• MRI systems with static magnetic field strengths up to 1.5 Tesla.• Usable within the MRI system bore with Specific Absorption Ratios (S.A.R.'s) up to 4.0 w/kg (peak). Use with higher S.A.R.'s greatly increases the risk of patient burns.• Non-Magnetic materials are used in the construction of these assemblies.• If scanned directly across the plane of the ECG electrode element, a slight image distortion may be seen at the skin surface where the electrode element is positioned.
ixPrecautionsECGAn inoperative ECG monitor is indicated by absence of an ECG waveform and a simultaneousLead Fail alarm.For best ECG, Heart Rate, S-T Segment, and/or Respiration monitoring, always select theoptimum lead configuration which has the least artifact and largest waveform(s) being detectedfor monitoring use.Failure to respond to a Lead Fail alarm will cause a lapse in your patient’s monitoring. Alwaysrespond promptly to this and any other alarms.Heart rate values may be adversely affected by cardiac arrhythmia, or by operation of electricalstimulators.NIBPAlways use recommended NIBP cuffs and hoses. Avoid compression or restriction of NIBP cuffhose.When using the NIBP portion of this instrument to measure blood pressure, remember that thepatient’s blood pressure readings are not continuous, but are updated each time a blood pressuremeasurement is taken. Set a shorter interval for more frequent updating of the patient’s bloodpressure.Do not attach the cuff to a limb being used for infusion. Cuff inflation can block infusion, possiblycausing harm to the patient.Frequent NIBP measurements can cause pooling of the blood in the limb (hemostasis), andperipheral tissue/nerve damage. Allow sufficient time between measurements for bloodrecirculation to prevent pooling of the blood in the limb.Arrhythmic and/or erratic heart beats (or severe motion artifact, such as tremors or convulsions)can result in inaccurate readings and/or prolonged measurements. If questionable readings areobtained, re-check patient’s vital signs by alternate means before administering medication.To prevent possible nerve damage to the limb, apply the NIBP cuff as recommended by currentAmerican Heart Association (AHA) guidelines for blood pressure monitoring.To ensure accurate and reliable measurements, use only recommended patient cuffs/hoses. Forbest accuracy, use the appropriate cuff size for each patient as recommended by the current AHAguidelines for blood pressure monitoring.Always tighten the cuff air hose connections snugly into place for proper operation.Some reusable NIBP cuffs contain a medical-grade latex rubber. Patients sensitized to latexrubber can have an allergic reaction when exposed to this material. Avoid the use of cuffs whichcontain latex rubber on patients who are allergic to this material.Routinely inspect the cuff and hose assemblies for proper attachment and orientation. Replacecuff and/or hose assemblies with cracks, holes, tears, cuts, etc. that could cause leaks in thesystem. If cuff and/or hose assemblies with damage which could result in leaks are used,prolonged and/or inaccurate patient readings could result.To prevent skin abrasion, apply and remove cuff carefully. Keep Velcro® (hook and latch)retention areas away from the skin.
xPrecautionsSpO2Avoid placement of the SpO2 sensor on the same limb with an inflated blood pressure cuff. Cuffinflation could result in inaccurate readings and false alarm violations.SpO2 monitoring requires the detection of valid pulses to correctly determine SpO2 and HeartRate values. During conditions of gross artifact, or in the absence of valid pulses, the SpO2 /ratevalues may not be correct.The SpO2 monitoring portion of this monitor is intended to measure arterial hemoglobin oxygensaturation of functional hemoglobin (saturation of hemoglobin functionally available fortransporting oxygen in the arteries). Significant levels of dysfunctional hemoglobins, such ascarboxyhemoglobin or methemoglobin, may affect the accuracy of the measurement. Also,Cardiogreen and other intravascular dyes may, depending on their concentration, affect theaccuracy of the SpO2 measurement.Always shield the SpO2 sensor from extraneous incident light sources. Such extraneous light cancause SpO2 reading or pulse detection errors.Frequently inspect the SpO2 sensor site for possible pressure tissue necrosis during prolongedmonitoring. Reposition the sensor at least every four (4) hours. Special care should be exercisedwhen tape is used to secure the sensor, as the stretch memory properties of most tapes can easilyapply unintended pressure to the sensor site.The numeric measurement values are updated every one (1) second on the monitor display.A pulse oximeter should be considered an early warning device. As a trend towards patientdeoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter tocompletely understand the patient’s condition.The pulse oximeter feature in this monitor is designed to display functional SpO2 values.The pulse oximeter pulsatile waveform is not proportional to the pulse volume, but adjusts thewaveform amplitude as needed for proper viewing.All monitor alarms are categorized as medium priority, unless otherwise specified.Arrhythmic and/or erratic heart beats (or severe motion artifact, such as tremors or convulsions)can result in inaccurate readings and/or prolonged measurements. If questionable readings areobtained, re-check patient’s vital signs by alternate means before administering medication.RespirationWhen setting up respiration monitoring, always observe and adjust the respiration gain of themonitor while watching the patient’s breathing efforts before completing selection of the gainsetting. Failure to do this can result in inaccurate readings, or false respiration detection.End-tidal CO2 (EtCO2)Verify that the patient’s breathing efforts and timing coincide with the monitor’s waveform beforecompletion of the patient set-up.The EtCO2/N2O measurements are automatically pressure compensated over an ambient pressurerange from 576 to 788 mmHg.The EtCO2/N2O measurement displays the sampled value within 1 second of when the gas wassampled.The alarm tone volume exceeds 60 dBA at a distance of 1 meter when the alarm tone volumeadjustment is set above selection number 8.Frequently inspect the EtCO2 patient tubing for proper gas flow. Avoid kinking of the EtCO2patient tubing that can result in leaking, reduction, or cut-off of the sample gas flow. Inaccurate gasmeasurements could result.
xiPrecautionsEnd-Tidal CO2 (Continued)EtCO2 patient tubing and its associated components are intended for single-patient use only.Avoid cleaning or disinfecting these items for reuse. Inaccurate gas measurements could result.To prevent inaccurate or missed readings, keep the EtCO2 patient tubing clear of any movingmechanisms which may kink, cut or dislodge the patient tubing.Do not overtighten the patient gas sample line to the water trap connector. Overtightening thisconnector can cause failure of the water trap assembly and resultant inaccurate (artificially low)patient gas measurements.Avoid connecting the EtCO2 calibration gas canister to the monitor by any method other thanwith the designated calibration tubing. Connecting by any other method could invalidate thecalibration, and/or damage the monitor.Respiration rate measurement errors could result during ventilation rates above 80 breaths perminute.Anesthetic AgentsInadequate ventilation of the monitor may cause inaccurate readings or damage to electroniccomponents.Ensure that the exhaust gas is not removed from the monitor under too strong a vacuum. Toprevent this condition, there must always be an opening to the room air. Too high a vacuum levelmay change the operating pressure of the monitor and cause inaccurate readings or internaldamage.Inspect waste gas line for deterioration on a regular basis. Replace as needed.Remove sampling line from patient airway whenever nebulized medications are being delivered.Use only Invivo sampling lines and accessories; other sampling lines may cause inaccuratereadings and malfunctions.Some Hydrocarbons (e.g. Acetone, Methane) may cause a mixed agent alarm to occur.Replace the sampling line and inspect water trap between each patient use.Do not overtighten the patient gas sample line to the water trap connector. Overtightening thisconnector can cause failure of the water trap assembly and resultant inaccurate (artificially low)patient gas measurements.Routinely inspect the hose assemblies for proper attachment and orientation. Replace hoseassemblies with cracks, holes, tears, cuts, etc. that could cause leaks in the system. If hoseassemblies with damage which could result in leaks are used, prolonged and/or inaccurate patientreadings could result.If questionable anesthetic agent gas measurements are observed, recheck patient connections,anesthesia gas machine and/or vaporizer before re-adjusting anesthesia delivery.Routinely verify the monitor’s internal barometric pressure reading with local conditions duringthe initial start-up period.
xiiPrecautionsAnesthetic Agents (Continued)With no gas reading (Agent Icon box with white X for agent identification and agent values of “---”) when Agent Vaporizer is first turned on, it may take 30 seconds to 1.5 minutes for agentidentification and reading to be displayed. Once identification is established, changes inconcentration are virtually immediate. With a 200% change in concentration, an auto Zero willoccur, and full accuracy of the changed concentration will be accomplished within approximately30 seconds.Whenever the 3160 MRI Physiological Monitoring System Agent sensor changes from steady statecondition, the 3160 MRI Physiological Monitoring System will perform an auto zero to restabilizethe sensor readings. During this time, 15 seconds to 1.5 minutes, it is possible for a falseidentification and concentration value to occur. Examples are as follows:a. No gas, during warm-up and when sample line is disconnected.b. Applying sample line for the first time.c. When switching from one Agent to another.d. Applying N2O in concentrations of 70% or more.e. Going from N2O of greater than 50% to 0%.f. When going from high Agent concentrations to low or off.OtherThis product, or any of its parts, should not be repaired other than in accordance with writteninstructions provided by Invivo, or altered without prior written approval of Invivo Corporation.The user of this product shall have the sole responsibility for any malfunction which results fromimproper use, faulty maintenance, improper repair, damage, or alteration by anyone other thanInvivo, or its authorized service personnel.This monitor is equipped with a demonstration mode which displays simulated electronic patientdata for training or demonstration purposes. Do not attach a patient to the monitor whenever thissimulation is present on the monitor display (“SIMULATION” can also be seen in the screencenter). Failure to properly monitor the patient could result.The patient connector inputs for all parameters are protected against the use of a defibrillator byinternal circuitry, and when the recommended patient cables or accessories are used. The use ofthis circuitry and these recommended cables and accessories also protects against the hazardsresulting from use of high frequency surgical equipment.There are no known electromagnetic or other hazardous interference between the monitor andother devices. However, care should be taken to avoid the use of cellular phones or otherunintended radio-frequency transmitters in the proximity of the monitoring system.This monitor uses rechargeable batteries which contain hazardous material, which must berecycled, or disposed of properly. For proper disposal methods, contact your local Invivorepresentative or distributor.Avoid ammonia, phenol or acetone based cleaners for they may damage the monitor surface.Dispose of the monitor and parts thereof according to local regulations.
xiiiPrecautionsOther (Continued)Notes, Cautions and Warnings. In the body of the manual notes, cautions and warnings are asshown below to make them stand out on the page. The following is a description of the format andmeaning of Notes, Cautions and Warnings:a. Notes. Notes are presented as shown below. Notes contain supplemental informationwhich Invivo has deemed especially important.b. Cautions. Cautions are presented as shown below. Cautions are used for the wordsand/or terms which alert the user to the possibility of a problem with the deviceassociated with its use or misuse. Such problems may include device malfunctions,device failure, damage to the device or damage to other property.c. Warnings. Warnings are presented as shown below. Warnings are used for the wordsand/or terms which alert the user to possible injury, death or other serious adversereactions associated with the use or misuse of the device.NOTEThis is a sample note.CAUTIONThis is a sample caution.WARNINGThis is a sample warning.
xivUSER RESPONSIBILITYThis product will perform in conformity with the description contained in this operators manualand accompanying labels and/or inserts, when assembled, operated, maintained and repaired inaccordance with the instructions provided. This product must be checked and calibratedperiodically. A malfunctioning product should not be used. Parts that are broken, missing, plainlyworn, distorted or contaminated should be replaced immediately. Should such repair orreplacement become necessary refer unit to qualified service personnel. This product or any of itsparts should not be repaired other than in accordance with written instructions provided by themanufacturer, or altered without written approval of Invivo. The user of the product shall have thesole responsibility for any malfunction which results from improper use, faulty maintenance,improper repair, damage or alteration by anyone other than Invivo or Invivo authorized servicepersonnel.Using this Manual. Whenever the various options are discussed, “XXX” is used to indicate avariable setting. It is required that every operator read this manual completely, including anypatient information in sections about monitoring features the operators monitor does not have,before attempting to operate the 3160 MRI Physiological Monitoring System.The figures contained in this manual show a fully equipped monitor. Therefore, figures withinthis manual may depict monitoring features that your monitor may not contain. For informationon features and enhancements that are not contained on your monitor, contact Invivo at (407) 275-3220.Precautions (listed earlier in this section) cover of wide ranges of information crucial to the safemonitoring of patients. It is required that every operator read the PRECAUTIONS completely,including the Precautions associated with monitoring features that the operators monitor does nothave, before attempting to operate the 3160 MRI Physiological Monitoring System.This device is covered under one or more of the following U.S. Patents: 5,482,036; 5,490,505;5,632,272; 5,685,299; 5,758,644; 5,769,785; 6,002,952; 6,036,642; 6,067,462; 6,206,830;6,157,850; 6,277,081 and international equivalents. U.S.A. and international patents pending.Possession or purchase of this device does not convey any express or implied license to use thedevice with replacement parts which would, alone, or in combination with this device, fall withinthe scope of one or more of the patents relating to this device.For further information or assistance with this product:Invivo Corporation407-275-3220 or 800-331-3220
xv3160 MRI Physiological Monitor AccessoriesECGItem Description Part NumberQuadtrode® MRI ECG Electrodes, 50/box .......................................................................................9303NMRI ECG Patient Lead Wire Set..........................................................................................................9218ECG/EEG Skin Prep Gel, 1 tube 4 ounce ............................................................................................9009Non-Invasive Blood PressureReusable BP Cuffs and HosesTwin-Lumen Adult Air Hose (18 ft. length) .................................................................................... 9010MSingle-Lumen Neonatal NIBP Air Hose (18 ft. length) ............................................................... 9010NMInfant MRI BP Cuff......................................................................................................................9050MNLPediatric MRI BP Cuff .................................................................................................................9060MNLAdult Standard MRI BP Cuff.......................................................................................................9070MNLAdult Large Arm MRI BP Cuff ...................................................................................................9080MNLAdult Thigh MRI BP Cuff ...........................................................................................................9090MNLDisposable BP CuffsNeonatal NIBP Cuff, Disposable, Size A, Velcro........................................................................ AN01AVNeonatal NIBP Cuff, Disposable, Size B, Velcro ........................................................................ AN02AVNeonatal NIBP Cuff, Disposable, Size C, Velcro ........................................................................ AN03AVEnd-Tidal CO2EtCO2 Sampling Kit...........................................................................................................................9010DContains 20 foot co-extruded sampling tube polyethylene inner core with PVC jacket, Nafion® tube, elbow adapter and 0.8 micron disk filter.Adult EtCO2 Cannula ...........................................................................................................................9012Pediatric EtCO2 Cannula ......................................................................................................................9013SpO2Spare Wireless Pulse Oximeter Module............................................................................................... 9311SpO2 Grip Sensor............................................................................................................................... 9399B
1-1SECTION 1INTRODUCTION1.0 INTRODUCTION.This manual describes a fully configured monitor, and may include features and/or options thatare not included in your monitor. For additional information, contact your local salesrepresentative, or Invivo Customer Service.1.1 Product Description. The Model 3160 MRI Physiological Monitoring System is designedto assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving MagneticResonance environment. A combination of the latest wireless communication, radio frequency (RF)shielding, digital signal processing (DSP), and adaptable mounting technologies address the challengesassociated with patient monitoring in the MRI area. Built on Invivo’s strong heritage in MRI patientvital signs monitoring, the 3160 provides accurate, continuous, and reliable performance during allphase of MRI applications.The standard 3160 configuration consists of wireless electrocardiogram (ECG), wireless pulseoximetry (SpO2), and non-invasive blood pressure (NIBP). Optional parameters include end-tidalCO2 and anesthetic agents.The 3160 system consists of the following components:a. Wireless Processing Unit. The Wireless Processing Unit (WPU) houses thecircuitry and hardware for support of the standard and optional patient monitoringparameters. The transceivers and antennas that support wireless communicationwith the ECG and SpO2 modules as well as the Display Controller Unit are alsopart of the WPU. The unit is powered by an AC – DC power adapter or tworemovable batteries that are recharged by the same power adapter. The batteriesprovide 8 hours of continuous operation.b. Patient Connection Unit. The Patient Connection Unit (PCU) contains theconnectors that support all the non-wireless parameters (i.e. NIBP, EtCO2, etc.)c. Display Controller Unit. The WPU communicates to the Display Controller Unit(DCU) via a bi-directional 2.4 GHz communication link. The large color LCDdisplay, keypad, and recorder of the DCU form an easy-to-use user interface fordisplay, control, and documentation of the system patient monitoring parameters.d. Wireless ECG Module. The Wireless ECG (WECG) module communicates twoleads of ECG simultaneously to the WPU. These two leads of ECG can bedisplayed at the DCU and are output from the WPU unit for interface to the MRIsystem cardiac gating input.e. Wireless SpO2 Module. The Wireless SpO2 (WSpO2) communicates the SpO2value and pulse waveform to the WPU. The information is available for display atthe DCU and is output from the WPU for interface to the MRI system pulseperipheral gating input.1.1.1 System Mounting. The Model 3160 MRI Physiological Monitoring System is built upon anadaptable mounting platform where the system can be configured in a traditional pole mountconfiguration or mounted directly onto the MRI table. The MRI table mount provides an effectivemeans of allowing the Model 3160 to travel along with the patient on the MRI table thus improvingthroughput and efficiency.1.1.2 System Parameters. The 3160 MRI Physiological Monitor System Parameters allowsimultaneous processing and display of up to five (5) parameters, three (3) waveforms and associatednumeric values from each different parameter. All the Patient Information is clearly displayed on a FlatPanel Display Screen.
1-2The 3160 MRI Physiological Monitoring System includes the following Vital SignParameters:1.1.3 User Interface. A simple to use interface has been developed to minimize operator learningtime. On the Display Control Unit (DCU), there is a Rotary Knob (which detents from selection toselection) that is used to access the parameter menu's, access the various setup features and finalize anychanges to the setup of the monitor. Frequently used menus (such as: Alarms, Trends and Recorder)have a Control Key which, when pressed, will open the associated menu. On the Wireless ProcessorUnit (WPU), the operator needs an external display and a keyboard to access the various features.1.1.4 Versatility. With its diverse offering of vital sign parameters, the 3160 MRI PhysiologicalMonitoring System may be configured to meet the monitoring needs of a wide spectrum of patientsfrom Neonate to Adults. Every available parameter may be easily accessed and adjusted to the uniqueneeds, condition and situation of each patient.1.2 Wireless Processor Unit (WPU). The WPU contains wireless transceivers, data acquisitionand processing circuitry that communicate with the wireless Display Control Unit (DCU), ECG(WECG) module and SpO2 (WSpO2) module.1.2.1 Operating Environment. The WPU is designed to operate at the 5,000 Gauss line in thegenerated RF field of an MRI system measured from the center line of the bore.1.2.2 Power Supply. The WPU Power Supply is designed to operate on the floor at least 10 feetfrom a 1.5 Tesla unshielded MRI system (200 Gauss). When attached, the power supply charges theWPU battery pack whether the WPU is operating or not.1.2.3 Battery Operation. The WPU will operate at least eight (8) hours with EtCO2 and all optionaldevices running with NIBP performing automatic readings at five (5) minute intervals. Figure 1-1. Patient Connection Unit (PCU)1.3 Patient Connections. The physical patient connections for NIBP and the Anesthetic Agentsoptions are located on the Patient Connection Unit (PCU, See Figure 1-1). ECG, SpO2 andRespiration all use wireless technology to deliver their measurements to the Wireless Processor Unit(WPU).1.3.1 NIBP and Agent Monitoring. The PCU contains the physical connections for the Non-Invasive Blood Pressure (NIBP) and, when installed, the optional Anesthetic Agents parameters. IfAnesthetic Agents is installed, the PCU also contains a water trap to prevent moisture contamination ofthe agent components.a. Operating Environment. The PCU is designed to operate at the 5,000 Gauss line inthe generated RF field of an MRI system measured from the center line of the bore.• Single Lead ECG • Pulse Oximetry • NIBP• EtCO2 • Respiration • Anesthetic Agents
1-31.3.2 ECG Monitoring. ECG is monitored using an ECG Telemetry Transmitter (WECG). TheWireless ECG Module consists of a wireless transceiver to communicate with the WPU and convertthe ECG signals into radio signals for transmission to the Wireless Processor Unit. The module alsoreceives information through the wireless link, converts the information to electrical signals andperforms the commanded task (i.e. lead configuration change, scaling, etc.). a. Compatability. The Standard Wireless ECG Module supports the four ECG electrodeplacement used with the Quadtrode (Part # 9303), Quadtrode CV, Neonatal Quadtrodeand MRI ECG Patient Cable and Lead wires (Part # 9340) for display of Lead II.b. Visual Indicators. The WECG module contains one (1) bi-color LED that indicatesthe status of the battery charge.c. Battery Life. The WECG module will operate at least eight (8) hours on a fullycharged battery.1.3.3 SpO2 Monitoring. SpO2 is monitored using a SpO2 Telemetry Transmitter (WSpO2). TheWireless SpO2 Module consists of a wireless transceiver to communicate with the Wireless ProcessorUnit and convert the SpO2 pulse signal into radio signals for transmission to the Wireless ProcessorUnit (WPU).a. Visual Indicators. The WSpO2 module contains one (1) bi-color LED that indicatesthe status of the battery charge.b. Battery Life. The WSpO2 module will operate at least eight (8) hours on a fullycharged battery1.4 Display Control Unit (DCU). The DCU provides control and display of the monitoredparameters. Control of the Monitoring Features is provided through the use of a Rotary Knob; as theoperator turns the Rotary Knob (either clockwise or counterclockwise), with each detent the nextMenu-Select Icon (Vital Sign Numerical Display) will become highlighted (selected) and, when theappropriate display is selected, pressing the Rotary Knob will bring up the menu for that parameter.For control and adjustment of the operation and features, the Keypad contains three separate sets ofpushbutton keys which contain both operational and menu-select keys.1.4.1 DCU Controls. (See Figure 1-2) The DCU front panel contains all the controls and access forcomplete patient monitoring. Control is provided by the pushbutton keys and Rotary Knob. Thefollowing is a general description of the DCU. Figure 1-2. The Front Panel
1-4a. The Rotary Knob. The Rotary Knob is located to the right of the Display Screen. Thefunction of the Rotary Knob is menu specific. For this reason, its various functions aredescribed throughout this document where it is used; in general, however, the RotaryKnob operates as described below:(1) As the Rotary Knob is rotated, either clockwise or counterclockwise, themonitor display “scrolls” through the various screen items (screen icons, menuoptions and patient parameters) which are available for selection. When theappropriate item is “highlighted,” it may be selected by pressing and releasingthe Rotary Knob. All menus have a RETURN option which will return themonitor to the previous menu selection.(2) During normal operation each active parameter has a Menu-Select icon on thescreen. When the Rotary Knob is rotated, the Menu-Select icon which is beingpointed at becomes “highlighted.” Rotating the Rotary Knob will cause themonitor to “scroll through” the available menu selections. Once the appropriateMenu-Select icon is highlighted, pressing the Rotary Knob completes theselection and brings up the required menu. Once the menu is selected, theRotary Knob is used to scroll through the available choices and makeadjustments to the selected parameter. The following Menu-Select Icons maybe available on the Normal Screen (depending on which parameters areavailable, enabled and turned on): ECG, NIBP, SpO2, EtCO2 and Agents. Figure 1-3. The Top Keypad Setb. The Top Keypad Set. (See Figure 1-3) There are six push keys in the top keypad set.The top three (FREEZE, EVENT MARK and ZERO ALL) provide direct control ofa monitor feature while the bottom three (SETUP, ALARMS SCREEN andRECORDER SETUP) provide access to operational menus. The six push keys aredescribed below: (1) FREEZE. The 3160 MRI Physiological Monitoring System freezes theECG waveform from Trace A for closer examination upon user demand.When the ECG trace is active, pressing the FREEZE key will freeze it into theTrace B location while Trace A remains active. When the trace is frozen,pressing the FREEZE key will release it. A “Blue Box” appears around thefrozen waveform as a visual indication that the waveform is not active. Whilethe Freeze feature is active, the monitor will not allow any changes to theParameter Setups or Display; if the operator attempts to access thePARAMETER SELECTION menu, a WARNING Box alerts the operatorthat entry to the selected menu is not allowed while FREEZE is enabled. (2) EVENT MARK. The EVENT MARK key prints a marker on the ECGRecorder Strip when the printer is running. If the printer is not running,pressing this key has no effect. (3) ZERO ALL. This feature is not available. Pressing this key will display adialog box that alerts the operator that no Invasive Pressures are enabled. (4) SETUP. The SETUP key allows the operator to access the various availablesetup options.
1-5 Figure 1-4. The Middle Keypad Setc. The Middle Keypad Set. (See Figure 1-4) The middle keypad set contains six pushkeys. The three on the left provide control of the NIBP monitoring feature with two ofthe keys (NIBP START/STOP and NIBP STAT) providing direct control of NIBPmeasurements and the third (NIBP INTERVAL) bringing up a menu that allowsadjustment of the NIBP auto mode interval feature. On the right side of this set are twokeys which control the Trending feature of the monitor (TRENDS and CLEARTRENDS) while a third (RECORD) provides a hardcopy printout of selectedparameters as specified by operator adjustments in the RECORDER Menu. The sixpush keys are described below: (5) ALARMS SCREEN. The ALARMS SCREEN key is a dual function keythat allows the operator to setup the Alarms monitoring feature. When themonitor display is in the Normal Screen and the ALARMS SCREEN key ispressed, the Main Alarm Setup Screen will appear; when the monitor displayhas any icon highlighted and the ALARMS SCREEN key is pressed, anAlarm Setup Screen for the highlighted parameter appears. (6) RECORDER SETUP. The RECORDER SETUP key allows the operatorto setup the Recorder option. (1) NIBP START/STOP. This key starts a new NIBP measurement, or stops ameasurement that is already in progress.. (2) NIBP INTERVAL. Pressing the NIBP INTERVAL key brings up the NIBPINTERVAL Menu where the cycle time (time between readings) of the NIBPAutomatic Reading Mode may be adjusted. (3) NIBP STAT. This key starts the NIBP STAT Mode measurements. Thismode may be terminated by depressing the NIBP START/STOP key. TheSTAT Mode performs up to five (5) NIBP measurements in rapid succession(with a short pause between readings) within a maximum time frame of five(5) minutes. (4) TRENDS. The TRENDS key allows the operator to setup the Trendmonitoring feature. The exact operation of the TRENDS key is based onwhether or not a feature is currently highlighted. If a feature is currentlyhighlighted, pressing the TRENDS key will bring up a Trend which is specificto the highlighted feature; if a feature is not currently highlighted, pressing theTRENDS key will bring up the HISTORY Menu and Tabular Display (SeeSection 5).
1-6 Figure 1-5. The Bottom Keypad Setd. The Bottom Keypad Set. (See Figure 1-5) The bottom keypad set is not grouped likethe top and middle, but are grouped around the Rotary Knob. There are three push keysin this set (NORMAL SCREEN, STANDBY and ALARM SILENCE) whichprovide direct control of operational features of the monitor. The three push keys aredescribed below. (5) CLEAR TRENDS. Pressing the CLEAR TRENDS key allows the operatorto clear all the stored data from memory. To prevent accidental erasure ofpatient data, there is a Yes/No box associated with this key that appears toensure that the operator meant to clear the trend data. (6) RECORD. Pressing this key records the Single Trace or Dual Trace selections(as specified by operator adjustments made in the RECORDER Menu).The recorder stops automatically after approximately 30 seconds, or when theRECORD key is pressed again; in either case, the printout ends with a “SnapShot” of the active patient parameter data. (1) NORMAL SCREEN. Pressing the NORMAL SCREEN key returns the3160 MRI Physiological Monitoring System from any menu to the normalscreen. (2) STANDBY. Pressing the STANDBY key places the 3160 MRIPhysiological Monitoring System into the Standby Mode. The monitor staysin Standby Mode until the STANDBY key is pressed a second time. Exceptfor the three (3) key features given below, the monitor operates normally bycontinuing to provide current patient information on the Display Screen.While in Standby Mode:• All audible alarms and nurse call are disabled. The disabled alarmsare indicated on the screen by the “X” through the bell shapedAlarm Status Symbol.• Active NIBP automatic measurements and STAT Modemeasurements are suspended.• No automatic printout is generated.• Default NIBP inflation pressures will be used for all manual NIBPreadings.
1-7(a) Alarm Silenced. Any new alarm conditions will cause the Alarm toreactivate and will also activate the Nurse Call Alarm.In addition, while alarms are silenced the following conditionsapply:•Unlatched Alarms. If the alarm system has been set toUNLATCHED in the ALARMS Menu and an Alarm Limitis violated, pressing the ALARM SILENCE key willsilence the Alarm Tone turns off the Nurse Call Alarm andputs the letter “S” in the Alarm Bell when an active AlarmLimit has been violated. While the parameter continues toviolate its limits, the numerics of the violating parametercontinue to flash on the screen.•Latched Alarms. If the alarm system has been set toLATCHED in the ALARMS Menu and an Alarm Limit isviolated, while the parameter continues to violate its limits,pressing ALARM SILENCE key stops the Alarm Tone,but the numerics remain red and continue to flash, evenafter the parameter returns to within its Alarm Limits.•ALARM HOLD. If the ALARM SILENCE key is pressedwhen the Alarm Tone is enabled but no alarm conditioncurrently exists, a “SOUND ON HOLD” message appearsin the upper center of the screen with a count down timerstarting at 180 (counting down at a 1 second rate) denotingthat the Alarm Tone is being temporarily held silent. Inaddition, an “H” will appear in the Alarm Status Symbol tofurther alert the operator that the Alarm System is on Hold.If the Alarm Tone is sounding, the first pressing of theALARM SILENCE key stops the Alarm Tone, turns offthe Nurse Call Alarm, and puts the letter “S” in the AlarmBell, and a second pressing enables Alarm Hold.The monitor automatically exits alarm hold after threeminutes, and the “SOUND ON HOLD” messagedisappears from the screen, reactivating the Alarm Tone(remember that a current alarm condition, which has beensilenced, will not sound again unless the condition returnswithin limits and then violates the limit again. Alsoremember that a silenced alarm may not be accompanied bythe Alarm Silence message). Pressing the ALARMSILENCE key before the three minute period is over willalso reactivate the Alarm Tone and nurse call alarm andremove the “SOUND ON HOLD” message from thescreen. (3) Alarm Silence Key. Pressing the ALARM SILENCE key, when the audiblealarms are enabled (as denoted by the absence of the “X” through the bellshaped Alarm Status Symbol), will affect the monitor as described below:WARNINGAn active silenced alarm may not be accompanied by an Alarm Silence message or an “S” in theAlarm Bell icon if the Alarm Hold sequence has been activated, or if a subsequent additional alarmhas occurred and self-corrected.
1-8The user is able to put alarms on hold (SOUND ONHOLD) only when the Alarm Tone is active (no X appearsin the bell symbol in the upper left of the screen). AlarmHold is useful for temporarily disabling the Alarm Tone.This might be useful, for example, when changing ECGleads or for any user activity which might cause a “false”alarm.1.4.2 DCU Display. The DCU display screen (See Figure 1-6) displays four groups of data: 1) theInformational Display, 2) the Vital Signs Trace Display, 3) the Vital Signs Numeric Display and 4) theStatus Display. The entire display screen, with its four different display groups, is called the “NormalScreen.” The four display areas are described below. Figure 1-6. The Normal Screena. Informational Display. (See Figure 1-7) The Informational Display is located at thetop of the Normal Display. This display provides the operator with the current time, theAlarm Status Bell Symbol, a flashing Heart Rate Symbol, a flashing Lung Symbol, anycurrent user messages and the current Patient Selection. Figure 1-7. The Informational Display(1) Time. The current time is displayed in a 12 or 24 hour format (hh:mm:ss). Thetime, date and clock mode (12 or 24 hour) is adjusted in the TIME Menu.(2) Alarm Status Symbol. The 3160 MRI Physiological Monitoring Systemsounds an Alarm Tone when any monitored parameter violates itsprogrammed Alarm Limits. The status of the Alarm Tone is indicated by thebell shaped Alarm Status Symbol.WARNINGWhen an “X” appears in the Alarm Status Symbol, the audible Alarm Tone will NOT sound for anyreason.
1-9(a) The letter “H” appearing in the bell indicates that the alarms have beenplaced on temporary Hold with the ALARM SILENCE key.Similarly, during power-up the “SOUND ON HOLD” messagedisplayed in the center of the screen indicates that the Alarm Tone istemporarily placed on hold. A 180 second countdown timer is alsodisplayed under the message.(b) The letter “X” appearing in the bell symbol indicates that the alarmshave been turned off from the ALARMS Menu or that Standby Modehas been engaged. In this case the Alarm Tone will not sound for anyreason.(c) The letter “S” appearing in the bell indicates that a current alarm hasbeen silenced with the ALARM SILENCE key. This feature willdisable only the alarms that were current when the ALARMSILENCE key was pressed, any new alarms will cause the AlarmTone to sound.(3) Heart Symbol. The Heart Symbol flashes on the screen each time a heart beatis detected. A tone is sounded at the same time (unless turned off in the ECGMenu or the SPO2 Menu).(4) Lung Symbol. The Lung Symbol flashes on the screen at the end of eachdetected breath whenever the EtCO2 monitoring feature is turned on (ifavailable).(5) Messages. These messages assist the operator in various aspects of theoperation of this monitor.(6) Patient Selection. Indicates the selected patient (ADULT or NEONATAL) forthe ECG and NIBP monitoring features. Figure 1-8. The Vital Signs Trace Displayb. Vital Signs Trace Display. (See Figure 1-8) The Vital Signs Trace Display is locatedin the middle of the Display Screen. This Display provides the operator with a trace ofthe selected parameters and also contains Numerical Vital Sign indications for theselected patient parameter.(1) The Vital Signs Trace Display portion of the screen is divided into six separatetrace areas. When turned on, the traces are fixed on the screen and updated withan Erase Bar. When a trace has been turned off, that portion of the screen isblank. The numeric values for each trace appear near the right screenboundary.(2) If the value is greater than or equal to a maximum calculable value, “OVR”(Over Range) is alternately displayed with the numeric value.
1-10(3) TRACE A, C and D are assigned according to parameter and come on/go offas parameters are turned on or off. Trace B is the location used for the“Freezing” of a waveform and is not assigned a parameter.The following is a description of each Trace:(4) TRACE A. The ECG trace is displayed in this position, unless turned off fromeither the ECG Menu or the SETUPS Menu. The main menu for this trace andfor the Heart Rate are brought up with the selection of the ECG Menu-SelectIcon.(a) The heart rate is displayed near the right screen boundary in the TraceA position. The numerics turn Red and flash if a Heart Rate AlarmLimit is violated. The color of the numerics is that of the selected HRsource.(b) The annotation below the heart rate value indicates the source of theheart rate, as selected from the ECG Menu, the NIBP Menu and theSPO2 Menu. Heart rate source choices are AUTO, ECG, SPO2 andNIBP (there is an ART option shown but selecting this item will bringup a message alerting the operator that the option is not available).(c) A red flashing numeric value on the screen indicates that an alarm forthis value has been violated. This provides a visual indication of alarmviolations, even when the Alarm Tone is turned off.(d) If AUTO is selected as the HR SOURCE, the highest-priority activeinput is utilized for displaying the heart rate, in the order listed above.The ECG trace must be off, or lead fail present, for the Auto source notto be the ECG trace.(e) If the monitor does not find a valid heart rate source when set toAUTO and NIBP is OFF, the heart rate is annotated with “NONE.”(f) The displayed lead for the ECG 1 is indicated near the left screenboundary.(g) A scale indicator is displayed near the left screen boundary in the ECGwaveform area(s). It represents a 1mV amplitude in the currentlyselected scale.(5) TRACE B. Trace B displays a frozen waveform for detailed analysis.(6) TRACE C. Trace C displays the SpO2 waveform (if SpO2 enabled).(7) TRACE D. Trace D displays the Respiration waveform (if EtCO2 enabled). Figure 1-9. The Vital Signs Numeric Displayc. Vital Signs Numeric Display. (See Figure 1-9) The Vital Signs Numeric Display islocated at the bottom and right of the display screen. This Display is divided withboxes that provide the operator with numerical indications for NIBP and Agents.
1-11The following is a description of the NIBP and Agents boxes.(1) Non-Invasive Blood Pressure (NIBP). NIBP is the first parameter (from theleft) displayed in the Vital Signs Display. The Systolic, Diastolic and Meanblood pressure values are displayed along with measurement information suchas the Elapsed Time (ET) since the last measurement and the time until thenext measurement (if in the Automatic Mode). While in the Manual mode,MANUAL is shown in the place of the time until the next measurement.During a reading cycle the current cuff pressure is displayed (“CUFF: XXX”).Between the measurements the elapsed time (time since the last reading) isdisplayed (ET= 00:00:00) instead of the cuff pressure.The NIBP error messages are shown in place of the “NEXT: 00:00:00.” Iferrors are detected by the NIBP circuitry, one of the following messages aredisplayed which preclude the determination of the blood pressure:(a) OVER PRES: Cuff inflation pressure has exceeded 280 ±5 mmHg.(b) CALIB: Monitor has detected DC offset below 1 mmHg or above 11mmHg.(c) NOT INFLATING: Cuff inflation runs longer than 30 seconds.(d) LONG PRES: Cuff pressure remains at one level for more then 30seconds.(e) CUFF LEAK: The cuff inflation pump has run for more than 20seconds. Check hose and cuff connections.(f) RESID PRES: Cuff pressure above 20 mmHg for more then 180seconds.(g) WRONG CUFF: The wrong cuff is attached for the patient setting.Select Adult or Neo (as appropriate) in the SETUPS Menu.(2) Agents. The Agents box is in the middle of the Normal Screen. This boxdisplays the numerical values for a wide variety of anesthetic agents. MostAnesthetic Agents are identified and specified by name next to the numericalvalue for the gas being measured.d. System Status Display. The System Status Display is located at the very bottom of theNormal Display and provides the operator with visual indications of the operationalstatus of the system. From left to right the symbols are the DCU Battery Status symbol,the WPU Communication/ Battery Status symbol and the Network symbol.(1) DCU Battery Status. This symbol is currently inactive. In the future it willprovide a visual indication of the DCU Battery Charge Status.(2) WPU Communication/Battery Status Symbol. This symbol is currentlyonly partially active. In the future it will indicate the Battery Status of theWPU. Currently it indicates the status of the communication link between theDCU and WPU by replacing the normal symbol of the Bed and Battery withone of the Bed boxed in red with a red X through it.(3) Network Symbol. This symbol provides the Network Designation for thewireless link. It is important that networked units are correctly identified toavoid the unintentional interference with a patient on another network ofmonitors. This symbol aids the identification of the selected network byproviding three different indications with shapes, colors and numbering allused to identify specific networks.
1-12e. Front Panel Power Light. (See Figure 1-5) The Front Panel Power Light (locatedbeneath the Rotary Knob) is a three color LED that indicates the AC/Battery Powercondition of the monitor. The Power Light will illuminate Green, Yellow and Red asdescribed below:(1) Green Light. A Green Light indicates that the monitor is connected to ACLine Power and that the internal battery circuitry is operational. In normaloperation, this light will be illuminated Green.(2) Yellow Light. A Yellow Light indicates Caution because the monitor isoperating on the internal batteries.(3) Red Light. A Red Light indicates Warning because monitor shutdown is soonto occur. The internal batteries have fallen below the required operationaloutput and an AC Wall Outlet should be located, and the monitor plugged intoit through the AC Power Adapter, immediately.f. Yes/No Menu. In various menus, the operator may accidentally make a selection thathas significant irreversible effects (e.g.: erasing patient data). To protect against suchaccidents a Ye s / N o Menu is associated with these selections. This menu has only twoactive selections: YES and NO. The operator must select one of the two choices toeither confirm the change to take place, or to cancel it. A delay of approximately 30seconds without any selection is equivalent to selecting NO. The Ye s / N o Menu isremoved upon operator selection, at the end of the time-out feature, by pressing theNORMAL SCREEN button or by pressing the STANDBY button.1.5 Cleaning. The monitor is not sterilizable. Never immerse the unit in any fluid or attempt toclean it with liquid cleaning agents. Remove dirt and dust from the monitor by wiping it with a soft,damp cloth.Stains can be removed from the case by scrubbing it briskly with a damp cloth. Unplug themonitor and remove the batteries before cleaning. Do not permit liquid to contact the front or rearof the monitor, or permit liquid to drip into the printer or cooling slots. Allow the unit to drycompletely before returning it to operation.1.5.1 Cleaning Accessories. Any reusable patient accessories should be cleaned after each use.Disposable patient accessories should be discarded and replaced with new items. To clean reusable accessories, first, remove the accessory from use. Remove any dirt or debrisusing soap and water. Avoid immersing accessory in any fluid for cleaning.Inspect the accessory for any cracks, holes, tears, cuts, etc., that could affect operation, andreplace as necessary.If disinfection is required, use only the recommended liquid surface disinfectants, unlessotherwise specified in the accessories listing. Recommended surface disinfectants include dilutesolutions of either quaternary ammonium compounds, iodophors or gluteraldehydes.WARNINGElectrical shock hazard: Turn off Monitor and disconnect from AC Power before cleaning. Do notimmerse the monitor in any water or liquid for any reason. Do not apply excessive pressure to themonitor display screen.
2-1SECTION 2INSTALLATION2.0 INSTALLATION2.1 Introduction. 2.2 Monitor Installation. Remove the monitor from the shipping carton and examine for anydamage which may have occurred during shipment. Check all materials against the packing list andpurchase request. Save all packing materials, invoice and bill of lading as these may be required toprocess a claim with the carrier if damage during shipment occurred. Contact Invivo Customer Servicefor prompt assistance in resolving shipping problems.2.2.1 Monitor Mounting. .a. Site Selection. Select a location where the monitor will not come in contact withliquids and where the heat will not raise the monitor's temperature above 44°C.Maintain adequate air flow around the unit to help keep it within the normal operatingtemperature range. Also, there are air holes on the bottom and rear of the monitor thatmust not become clogged or closed off. Humidity and temperature must nevercombine to cause condensation to form in or on this monitor.2.2.2 Preparing the 3160 MRI Physiological Monitoring System for Use. Perform the followingsteps to prepare the monitor for use:a. Ensure that you have read the Precautions and User Responsibility sections of thismanual. This provides important safety information.b. Ensure that there are no cracks in the monitor case or display.c. Ensure that all patient connections are intact.d. Ensure that all patient cables meet manufacturers recommended condition for patientuse. Visually inspect for breaks, cracks and/or fraying.e. Report any problems to Invivo, or an authorized Invivo Service Representative.f. Verify the accuracy and proper functioning before using the monitor on a patient.Never use a monitor that is suspected of being inaccurate or out of calibration.2.2.3 Monitor Start Up. Perform the following steps to bring the monitor on line for use:a. Connect the Power Cord to the A/C Power Cord Connection plug on the monitor backpanel.b. Ensure that the Panel Power Switch is set to the OFF position.c. Install the sealed batteries.d. Plug the Power Cord into an appropriate facility power source.e. Set the Power Switch to the ON positionf. It is recommended to allow the batteries to charge a minimum of 8 hours beforeutilizing the monitor for battery use. For normal use the monitor should be plugged intoan AC electrical outlet through the AC Power Adapter and not on battery power.CAUTIONTwo separate AS201 AC Power Adapters should never be plugged into the WPU and DCU units atthe same time. Failure to comply can result in a power overload conditin and cause serious damageto themonitor’s internal circuits.
3-1SECTION 3PREPARATION FOR USE3.0 PREPARATION FOR USE.3.1 Introduction. This monitor provides the operator with the ability to store and recall differentsystem configurations, select and display the available parameters, select special system functions, setthe date and time and select test menus. Access to this wide array of features is available through theSETUPS Menu which is accessed by pressing the SETUP Menu-Select Key.3.2 SETUPS Menu. (See Figure 3-1) On the DCU, pressing the SETUP Menu-Select keybrings up the SETUPS Menu; on the WPU, attach an external monitor and keyboard then select theSETUP Menu-Select key. From this menu, the operator has the ability to fine tune the operation of the3160 MRI Physiological Monitoring System to suit individual situations.a. DCU SETUPS Menu. While in the DCU SETUPS Menu, individual setupconfigurations may be saved and recalled, the available parameters may be turned offand on, the monitor sounds may be adjusted, the patient mode may be switchedbetween adult and neonate, the date and time may be adjusted, the network designationmay be set, the monitor may be set to default to the Factory or a User configuration. Inaddition to control over these features, this menu allows the sweep speed andrespiration speed to be selected. This menu has a time-out feature. If no action is takenfor approximately 60 seconds, the monitor will automatically return to the NormalScreen. Figure 3-1. The DCU SETUPS MenuNOTEIf a particular parameter is not installed, it can not be set to ON. Once the monitor is configured for aparticular procedure or user, the store and recall feature can be used to instantly reset the monitor.The SETUPS Menu is different from the DCU to WPU due to the different operationalrequirements of the separate units that comprise the 3160 MRI Physiological Monitoring System.Paragraph 3.2 will first discuss what is common between the two then divide into unique sections tocover the differences between the DCU and WPU Setups Menu.
3-2The following is a description of the operation of the DCU SETUPS Menu options:(1) Recall Setups. To select this menu option, turn the Rotary Knob until theRECALL SETUPS option is highlighted, then press the Rotary Knob toselect. Selecting this menu option will bring up the RECALL SETUPSsubmenu and allow the operator to Recall a previously stored Monitor Setup(See Figure 3-2). This menu has a time-out feature. If no action is taken forapproximately 60 seconds, the monitor will automatically return to theNormal Screen. Figure 3-2. The RECALL SETUPS MenuThe following is a description of the RECALL SETUPS Menu options:(a) A. To select this menu option, turn the Rotary Knob until A ishighlighted, then press the Rotary Knob to select. Selecting this menuoption brings up a Yes/No confirmation menu and, upon confirmation,will recall the setups for the monitor from the Memory Block A.(b) B. Except for using the Memory Block B, this menu option is identicalin function to menu option A.(c) C. Except for using the Memory Block C, this menu option is identicalin function to menu option A.(d) D. Except for using the Memory Block D, this menu option is identicalin function to menu option A.(e) E. Except for using the Memory Block E, this menu option is identicalin function to menu option A.(f) F. Except for using the Memory Block F, this menu option is identicalin function to menu option A.(g) USER DEFAULTS. Selecting this menu option recalls the setups forthe monitor from the USER DEFAULTS memory block. If no UserDefaults have been set, this selection will Recall the Factory Defaults.If the DEFAULT SETUPS is set to USER in the SETUPS Menu,the monitor will automatically recall the setups stored in thismemory block for new patients upon monitor power-up.
3-3(h) PRINT SETUPS. To select this menu option, turn the Rotary Knobuntil PRINT SETUPS is highlighted, then press the Rotary Knob toselect. Selecting this menu option brings up the PRINT SETUPSMenu, which provides a selection of system setups to print.(i) RETURN. Selecting this menu option returns the monitor to theNormal Screen.(2) Store Setups. To select this menu option, turn the Rotary Knob until theSTORE SETUPS option is highlighted, then press the Rotary Knob to select.Selecting this menu option will bring up the STORE SETUPS Menu andallow the operator to Store up to seven (7) sets of Monitor Setups for futureRecall (See Figure 3-3). This menu has a time-out feature. If no action istaken for approximately 60 seconds, the monitor will automatically return tothe Normal Screen Figure 3-3. The STORE SETUPS MenuThe following is a description of the STORE SETUPS Menu options:(a) A. Selecting this menu option will store all setups for the monitor in thestorage Memory Block A.(b) B. Except for using the Memory Block B, this menu option is identicalin function to menu option A.(c) C. Except for using the Memory Block C, this menu option is identicalin function to menu option A.(d) D. Except for using the Memory Block D, this menu option is identicalin function to menu option A.(e) E. Except for using the Memory Block E, this menu option is identicalin function to menu option A.(f) F. Except for using the Memory Block F, this menu option is identicalin function to menu option A.(g) USER DEFAULTS. Selecting this menu option will store all setupsfor the monitor in the storage Memory Block USER DEFAULTS.If the DEFAULT SETUPS is set to USER in the SETUPS Menu,the monitor will automatically recall the setups stored by this menuoption for new patients upon warm start.
3-4(h) PRINT SETUPS. Selecting this menu option brings up the PRINTSETUPS Menu which provides a selection of system setups to print.(i) RETURN. Selecting this menu option returns the monitor to theNormal Screen.(3) Parameter Selection. To select this menu option, turn the Rotary Knob untilthe PARAMETER SELECTION option is highlighted, then press the RotaryKnob to select. Selecting this menu option will bring up the PARAMETERSSELECTION Menu (See Figure 3-4). Figure 3-4. The PARAMETER SELECTION MenuSelection of this menu allows the operator to turn various parameters ON andOFF. If the parameter selected is not installed, attempting to turn it ON willcause the message “XXX IS NOT ENABLED” to be displayed. If the Freezefeature is enabled, changes to parameter selections are not allowed; if Freeze isenabled, the monitor displays a WARNING Box that alerts the operator thatthis menu may not be accessed.The following is a description of the PARAMETERS SELECTION Menuoptions:(a) ECG. Selecting this menu option will turn the ECG display ON(default) or OFF. The heart rate will remain on the screen, allowing it tobe displayed from another source, if the heart-rate source (the HRSOURCE selection) is set to AUTO.(b) NIBP. Selecting this menu option switches the NIBP ON (default) andOFF.(c) P1. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(d) P2. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(e) P3. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(f) P4. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(g) SPO2. Selecting this menu option switches SpO2 ON and OFF.(h) EtCO2. Selecting this menu option switches EtCO2 ON and OFF.
3-5(i) RESP. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(j) TEMP. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(k) AUX. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(l) AGENTS. (If option is installed) Selecting this menu option switchesthe Anesthetic Agent Option ON and OFF (default).(m) RETURN. Selecting this menu option returns the monitor to theNormal Screen.(4) Sound Adjust. Selecting this menu option will bring up the SOUNDADJUST Menu (See Figure 3-5) which allows the user to switch the AlarmTone ON and OFF, set the heart-rate tone source and set the volume for thedifferent sounds the 3160 MRI Physiological Monitoring System produces.While in this menu, all real tones are disabled and the message “REALTONES DISABLED” is displayed at the top of the screen. Note that only thesound is disabled and the violated alarms will still flash on the screen if theparameter's Alarm Limit is violated. This menu has a time-out feature. If noaction is taken for approximately 60 seconds, the monitor will automaticallyreturn to the Normal Screen. Figure 3-5. The SOUND ADJUST MenuThe following is a description of this menu's options:(a) ALARMS. Selecting this menu option will turn the alarm sound ONand OFF. When turned off, an “X” appears in the bell symbol on thescreen, and on the one in the menu option area, indicating that thealarm sound has been disabled. This menu option is identical to, andinteractive with, the SOUND menu option in the ALARMS Menu.WARNINGThe Alarm Tone can be set to OFF. Always check that the Alarm Tone setting is appropriate for eachparticular patient. Alarm Sound volume is adjustable for suitability to various clinical environments(where background noise may range from relatively quiet to noisy). Always verify that the user/attendant of this monitor can hear the Alarm Sound above the ambient noise.
3-6(b) HR TONE SRCE. Selecting this menu option will select the heart ratetone source. The options are OFF (default), QRS and SPO2. Whensource is QRS, the tone sounds at the detection of QRS from the ECGparameter. When source is SpO2, the tone sounds at the detection of thepulse from the Pulse Oximeter parameter.The pulse tone is modulated by the SpO2 value. The lower theSpO2 value the lower the pitch of the pulse tone will be.This menu option is identical to, and interactive with, the HRTONE SOURCE Menu option in the ECG and SPO2 Menus.(c) ALARM VOLUME. Selecting this menu option allows the selectionof volume for the Alarm Tone. The range is 1 - 10 (default is 4).The 3160 Patient Monitoring System generates the Alarm Tone(while in the VOLUME Menu) to provide the user with an audibleindication of the current volume-level setting.(d) PULSE VOLUME. Selecting this menu option allows the selection ofvolume for the pulse tone. The range is 1 - 10 (default is 4).The 3160 Patient Monitoring System generates the pulse tone(while in the VOLUME Menu) to provide the user with an audibleindication of the current volume-level setting.(e) CLICK TONE. Selecting this menu option turns the click tonegeneration of the device ON and OFF without affecting the adjustedvolume for the click tone.(f) CLICK VOLUME. Selecting this menu option allows the selection ofvolume for the click tone. The range is 1 - 10 (default is 4).The 3160 Patient Monitor generates the click tone (while in theVOLUME Menu) to provide the user with an audible indication ofthe current volume-level setting.(g) RETURN. Selecting this menu option returns the monitor to theNormal Screen.(5) Patient. Selecting this menu option determines the Adult (default) or theNeonatal Mode for the operation of the ECG and NIBP parameters.(a) ADULT. The initial NIBP inflation pressure is 170 mmHg. Themaximum inflation pressure is 285 mmHg. Also, the adult NIBPpre-amplifier and the adult NIBP algorithm are used. ECG Heart Ratedetection sensitivity is 200 µV minimum.(b) NEONATE. The initial inflation pressure is 120 mmHg. Themaximum inflation pressure is 150 mmHg. Also, the neonatal NIBPpre-amplifier and the neonatal NIBP algorithm are used. ECG HeartRate detection sensitivity is 100 µV minimum.(6) Set Time. Selecting this menu option will bring up the SET TIME Menu (SeeFigure 3-6). From the SET TIME Menu the time and date may be set. Thetime is displayed in the upper left corner of the screen. The clock continues tooperate when the power is off. The date format is MMM DD, YYYY (e.g., Jan01, 2001). When a hard copy printout is made, the time and date is printed onthe edge of the printout.
3-7 Figure 3-6. The SET TIME MenuThe following is a description of the operation of the SET TIME Menu options:(a) FORMAT. Selecting this menu option switches the format of the timedisplay between 12 hour and 24 hour.(b) SECOND. Selecting this menu option allows scrolling throughseconds.(c) MINUTE. Selecting this menu option allows scrolling throughminutes.(d) HOUR. Selecting this menu option allows scrolling through hours.(e) DAY. Selecting this menu option allows scrolling through days.(f) MONTH. Selecting this menu option allows scrolling through months.(g) YEAR. Selecting this menu option allows scrolling through years.(h) ENTER. Selecting this menu option enters the newly-selected timeand date when all changes are completed.Pressing ENTER after the new time and date are completely setputs the newly set time and date into effect. Otherwise, the old timeis restored upon exiting the SET TIME Menu.(i) RETURN. Selecting this menu options returns the monitor to theNormal Screen.(7) Default Setups. Selecting this menu option will switch the power-on defaultsbetween FACTORY and USER modes. If set to FACTORY, the monitor willpower up with the entire system reset to factory default values. If set to USER,the monitor will power up and automatically recall the user defaults frommemory.(8) Sweep Speed. Selecting this menu option will bring up the SWEEP SPEEDMenu. The SWEEP SPEED Menu allows the operator to switch the recorderand the screen trace speed between 25 and 50 mm/second. This menu option isidentical to, and interactive with, the SWEEP SPEED menu option inRECORDER Menu.NOTENo new window is provided for the following selections. The setting to be adjusted becomeshighlighted within the existing menu.
3-8(9) Respiration Speed. Selecting this menu option will bring up the RESPSPEED Menu. The RESP SPEED Menu allows the operator to set theRespiration Speed at the following predetermined levels: 25 mm/s, 12.5 mm/s,6.25 mm/s, 3.125 mm/s, 1.5625 mm/s and 0.33333 mm/s. Figure 3-7. NETWORK Menu(10) Network. Selecting this menu option brings up the NETWORK Menu. TheNETWORK Menu (See Figure 3-7) allow the operator to set the networkdesignation of the monitor. This designation must match between the DCU andWPU for the two units to communicate. This menu option is identical to, andinteractive with, the NETWORK option in the System Configuration Menu.(11) Service (Bio-Med). Selecting this menu option will bring up the SERVICE(BIO-MED) Menu (See Figure 3-8). The DCU SERVICE (BIO-MED) Menuprovides the operator with the ability to identify the Software Revision level,place the system into a Simulation Mode (used for training purposes only) andadjust the configuration of the system. Figure 3-8. The DCU SERVICE (BIO-MED) MenuNOTEThe SERVICE (BIO-MED) Menu should only be used by qualified service personnel thoroughlyfamiliar with the operation and service of this monitor.
3-9The following is a description of the options available in the SERVICE(BIO-MED) Menu:(a) S/W REV. Selecting this menu item brings up another window whichcontains detailed inforation about the operating software of the DCU.This window contains the revision level and date of build along withother technical information concerning the DCU software. To exit thiswindow, the operator either selects the OK button on the window or theNORMAL SCREEN key on the monitor front panel.(b) SIMULATION MODE. This menu option allows the operator to turnthe Simulation Mode ON. When selected the monitor will first displaya YES/NO Menu and require user confirmation before entering theSimulation Mode. While in the Simulation Mode the displayed patientinformation is computer generated and not actual patientdeterminations. As a safety feature, while in the Simulation Mode themessage “SIMULATION” is displayed in the center of the screen and,when printing any strip or chart, “SIMULATION” will appear on theprintout. To exit the Simulation Mode, the monitor must be poweredOff. Figure 3-9. The SYSTEM CONFIG Menu(c) SYSTEM CONFIG. The SYSTEM CONFIG Menu (See Figure 3-9) is brought up by selecting the SYSTEM CONFIG Menu option.Most of the options in this menu are sensitive and are, as a result,protected by a five (5) digit password that must be entered before theoption may be adjusted. The Language, Pressure Unit and Networkoptions are the only options in this menu which do not require that theservice code be entered.The following options are available in this menu:•ECG 1: Selecting this menu option will enable/disable theECG 1 module.•ECG 2: This option is not available on the 3160 MRIPhysiological Monitoring System.•NIBP: Selecting this menu option will enable/ disable theNIBP module.WARNINGThe Simulation Mode will display real looking waveforms which are computer generated. Themonitor will not monitor patients while in the Simulation Mode. Do not activate the SimulationMode when this monitor is connected to a patient. To exit the Simulation Mode, the monitor mustbe powered Off.
3-10•P1: This option is not available on the 3160 MRIPhysiological Monitoring System.•P2: This option is not available on the 3160 MRIPhysiological Monitoring System.•P3: This option is not available on the 3160 MRIPhysiological Monitoring System.•P4: This option is not available on the 3160 MRIPhysiological Monitoring System.•SPO2: Selecting this menu option will enable/disable theSpO2 module.•EtCO2: Selecting this menu option will enable/disable theEtCO2 module (if installed).•RESP: This option is not available on the 3160 MRIPhysiological Monitoring System.•TEMP 1 AND 2: This option is not available on the 3160MRI Physiological Monitoring System.•AUX: This option is not available on the 3160 MRIPhysiological Monitoring System.•CO: This option is for future service enhancement.•RECORDER: Selecting this menu option will enable/disable the RECORDER module.•CS COMM: Selecting this menu option will enable/disableCS COMM.•PARALLEL PORT: Selecting this menu option willenable/disable the Parallel/Printer Port.•ANALOG OUTPUT: Selecting this menu option willenable/disable the Analog Output Port.•NETWORK: Selecting this menu option provides amethod of connecting to a specific network.•ST-SEGMENT: This option is not available on the 3160MRI Physiological Monitoring System.•LINE FREQUENCY: Selecting this menu option switchesthe ECG Notch Filter between 50 Hz and 60 Hz. This filterdoes not apply to ECG Diagnostic Filter Mode.•LANGUAGE: Selecting this menu option allows theLanguage of the monitor to be switched between theavailable languages (English, German, Spanish, Portuguese,Italian, Dutch, Swedish and French). To enable the languagechange, the operator must exit the SYSTEM CONFIGmenu by selecting Return or pressing the NORMALSCREEN control key, and then turn the monitor Off thenOn.•PRESSURE UNITS: Selecting this menu option allows theBlood Pressure and EtCO2 Measurement units to beswitched between mmHg and kPa. See Appendix E for akPa to mmHg Conversion Chart.•MONITOR MODE: This menu item is set automaticallydepending on which unit is be looked at. For the DCU, thisoption is set to REMOTE MODE. For the WPU, this optionis set to LOCAL MODE.•RETURN: Selecting this menu option returns the monitorto the Service (Bio-Med) Menu.
3-11(d) RETURN. Selecting this menu option returns the monitor to theSETUPS Menu.(12) Return. Selecting this menu option returns the monitor to the Normal Screen. Figure 3-10. WPU SETUPS Menub. WPU Setups Menu. While in the WPU SETUPS Menu, the available parametersmay be turned off and on, the monitor sounds may be adjusted, the patient mode maybe switched between adult and neonate, and the date and time may be adjusted. Inaddition to control over these features, this menu allows the sweep speed andrespiration speed to be selected, and provides Qualified Service Personnel with Serviceand Calibration Information. This menu has a time-out feature. If no action is taken forapproximately 60 seconds, the monitor will automatically return to the NormalScreen.The following is a description of the operation of the WPU SETUPS Menu options:(1) Parameter Selection. To select this menu option, turn the Rotary Knob untilthe PARAMETER SELECTION option is highlighted, then press the RotaryKnob to select. Selecting this menu option will bring up the PARAMETERSSELECTION Menu (See Figure 3-11). Figure 3-11. The PARAMETER SELECTION MenuSelection of this menu allows the operator to turn various parameters ON andOFF. If the parameter selected is not installed, attempting to turn it ON willcause the message “XXX IS NOT ENABLED” to be displayed. If the Freezefeature is enabled, changes to parameter selections are not allowed; if Freeze isenabled, the monitor displays a WARNING Box that alerts the operator thatthis menu may not be accessed.
3-12The following is a description of the PARAMETERS SELECTION Menuoptions:(a) ECG. Selecting this menu option will turn the ECG display ON(default) or OFF. The heart rate will remain on the screen, allowing it tobe displayed from another source, if the heart-rate source (the HRSOURCE selection) is set to AUTO.(b) NIBP. Selecting this menu option switches the NIBP ON (default) andOFF.(c) P1. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(d) P2. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(e) P3. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(f) P4. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(g) SPO2. Selecting this menu option switches SpO2 ON and OFF.(h) EtCO2. Selecting this menu option switches EtCO2 ON and OFF.(i) RESP. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(j) TEMP. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(k) AUX. This option is not available on the 3160 MRI PhysiologicalMonitoring System.(l) AGENTS. (If option is installed) Selecting this menu option switchesthe Anesthetic Agent Option ON and OFF (default).(m) RETURN. Selecting this menu option returns the monitor to theNormal Screen.(2) Sound Adjust. Selecting this menu option will bring up the SOUNDADJUST Menu (See Figure 3-12) which allows the user to switch the AlarmTone ON and OFF, set the heart-rate tone source and set the volume for thedifferent sounds the 3160 MRI Physiological Monitoring System produces.While in this menu, all real tones are disabled and the message “REALTONES DISABLED” is displayed at the top of the screen. Note that only thesound is disabled and the violated alarms will still flash on the screen if theparameter's Alarm Limit is violated. This menu has a time-out feature. If noaction is taken for approximately 60 seconds, the monitor will automaticallyreturn to the Normal Screen.NOTEThe WPU does not contain a speaker and, therefore, it will not make a sound. The following settingswill affect the operation of the DCU.WARNINGThe Alarm Tone can be set to OFF. Always check that the Alarm Tone setting is appropriate for eachparticular patient. Alarm Sound volume is adjustable for suitability to various clinical environments(where background noise may range from relatively quiet to noisy). Always verify that the user/attendant of this monitor can hear the Alarm Sound above the ambient noise.
3-13 Figure 3-12. The SOUND ADJUST MenuThe following is a description of this menu's options:(a) ALARMS. Selecting this menu option will turn the alarm sound ONand OFF. When turned off, an “X” appears in the bell symbol on thescreen, and on the one in the menu option area, indicating that thealarm sound has been disabled. This menu option is identical to, andinteractive with, the SOUND menu option in the ALARMS Menu.(b) HR TONE SRCE. Selecting this menu option will select the heart ratetone source. The options are OFF (default), QRS and SPO2. Whensource is QRS, the tone sounds at the detection of QRS from the ECGparameter. When source is SpO2, the tone sounds at the detection of thepulse from the Pulse Oximeter parameter.The pulse tone is modulated by the SpO2 value. The lower theSpO2 value the lower the pitch of the pulse tone will be.This menu option is identical to, and interactive with, the HRTONE SOURCE Menu option in the ECG and SPO2 Menus.(c) ALARM VOLUME. Selecting this menu option allows the selectionof volume for the Alarm Tone. The range is 1 - 10 (default is 4).The 3160 Patient Monitoring System generates the Alarm Tone(while in the VOLUME Menu) to provide the user with an audibleindication of the current volume-level setting.(d) PULSE VOLUME. Selecting this menu option allows the selection ofvolume for the pulse tone. The range is 1 - 10 (default is 4).The 3160 Patient Monitoring System generates the pulse tone(while in the VOLUME Menu) to provide the user with an audibleindication of the current volume-level setting.(e) CLICK TONE. Selecting this menu option turns the click tonegeneration of the device ON and OFF without affecting the adjustedvolume for the click tone.(f) CLICK VOLUME. Selecting this menu option allows the selection ofvolume for the click tone. The range is 1 - 10 (default is 4).The 3160 Patient Monitor generates the click tone (while in theVOLUME Menu) to provide the user with an audible indication ofthe current volume-level setting.(g) RETURN. Selecting this menu option returns the monitor to theNormal Screen.
3-14(3) Patient. Selecting this menu option determines the Adult (default) or theNeonatal Mode for the operation of the ECG and NIBP parameters.(a) ADULT. The initial NIBP inflation pressure is 170 mmHg. Themaximum inflation pressure is 285 mmHg. Also, the adult NIBPpre-amplifier and the adult NIBP algorithm are used. ECG Heart Ratedetection sensitivity is 200 µV minimum.(b) NEONATE. The initial inflation pressure is 120 mmHg. Themaximum inflation pressure is 150 mmHg. Also, the neonatal NIBPpre-amplifier and the neonatal NIBP algorithm are used. ECG HeartRate detection sensitivity is 100 µV minimum.(4) Set Time. Selecting this menu option will bring up the SET TIME Menu (SeeFigure 3-13). From the SET TIME Menu the time and date may be set. Thetime is displayed in the upper left corner of the screen. The clock continues tooperate when the power is off. The date format is MMM DD, YYYY (e.g., Jan01, 2001). When a hard copy printout is made, the time and date is printed onthe edge of the printout. Figure 3-13. The SET TIME MenuThe following is a description of the operation of the SET TIME Menu options:(a) FORMAT. Selecting this menu option switches the format of the timedisplay between 12 hour and 24 hour.(b) SECOND. Selecting this menu option allows scrolling throughseconds.(c) MINUTE. Selecting this menu option allows scrolling throughminutes.(d) HOUR. Selecting this menu option allows scrolling through hours.(e) DAY. Selecting this menu option allows scrolling through days.(f) MONTH. Selecting this menu option allows scrolling through months.(g) YEAR. Selecting this menu option allows scrolling through years.(h) ENTER. Selecting this menu option enters the newly-selected timeand date when all changes are completed.NOTENo new window is provided for the following selections. The setting to be adjusted becomeshighlighted within the existing menu.
3-15Pressing ENTER after the new time and date are completely setputs the newly set time and date into effect. Otherwise, the old timeis restored upon exiting the SET TIME Menu.(i) RETURN. Selecting this menu options returns the monitor to theNormal Screen.(5) Sweep Speed. Selecting this menu option will bring up the SWEEP SPEEDMenu. The SWEEP SPEED Menu allows the operator to switch the recorderand the screen trace speed between 25 and 50 mm/second. This menu option isidentical to, and interactive with, the SWEEP SPEED menu option inRECORDER Menu.(6) Respiration Speed. Selecting this menu option will bring up the RESPSPEED Menu. The RESP SPEED Menu allows the operator to set theRespiration Speed at the following predetermined levels: 25 mm/s, 12.5 mm/s,6.25 mm/s, 3.125 mm/s, 1.5625 mm/s and 0.33333 mm/s.(7) Service (Bio-Med). Selecting this menu option will bring up the WPUSERVICE (BIO-MED) Menu (See Figure 3-14). The WPU SERVICE(BIO-MED) Menu provides the operator with the ability to identify theSoftware Revision level, place the system into a Simulation Mode (used fortraining purposes only), perform NIBP and SpO2 tests, calibrate the anestheticagent option (if available), calibrate the monitor and adjust the configuration ofthe system. Figure 3-14. The WPU SERVICE (BIO-MED) MenuThe following is a description of the options available in the SERVICE(BIO-MED) Menu:(a) S/W REV. Selecting this menu item brings up another window whichcontains detailed inforation about the operating software of the WPU.This window contains the revision level along with other technicalinformation concerning the WPU software. To exit this window, theoperator either selects the OK button on the window or the NORMALSCREEN key on the monitor front panel.NOTEThe SERVICE (BIO-MED) Menu should only be used by qualified service personnel thoroughlyfamiliar with the operation and service of this monitor.
3-16(b) SIMULATION MODE. This menu option allows the operator to turnthe Simulation Mode ON. When selected the monitor will first displaya YES/NO Menu and require user confirmation before entering theSimulation Mode. While in the Simulation Mode the displayed patientinformation is computer generated and not actual patientdeterminations. As a safety feature, while in the Simulation Mode themessage “SIMULATION” is displayed in the center of the screen and,when printing any strip or chart, “SIMULATION” will appear on theprintout. To exit the Simulation Mode, the monitor must be poweredOff.(c) NIBP TESTS. Selecting this menu option will bring up the NIBPTESTS Menu (See Figure 3-15).The following options are provided in this menu:•CALIBRATE. Selecting this menu option will displayNIBP CAL Offset Pressure and actual Pressure Reading inthe NIBP TESTS menu. These are used to verify andcalibrate the internal NIBP. Figure 3-15. NIBP TESTS Menu•LEAK TEST. Selecting this menu option will displayNIBP LEAK TEST with the Peak (beginning) Pressureand Final (current) Pressure displayed, along with thenumber of Passes and Failures of the test, to determine theleak rate of the NIBP system. To begin this test, highlightthe LEAK TEST menu option and press the Rotary Knob;to stop a test in progress, press the Rotary Knob a secondtime.WARNINGThe Simulation Mode will display real looking waveforms which are computer generated. Themonitor will not monitor patients while in the Simulation Mode. Do not activate the SimulationMode when this monitor is connected to a patient. To exit the Simulation Mode, the monitor mustbe powered Off.WARNINGThe Leak Test feature is for use by qualified service personnel only.Never initiate a Leak Test while the cuff is applied to a patient. Continuous cuff pressure could leadto patient injury.
3-17•PRINT OSC DATA. This option is for future serviceenhancement.•RETURN. Selecting this menu option returns the monitorto the Normal Screen.(d) GAS CAL. Selecting this menu option will bring up the GAS CALMenu (See Figure 3-16). Figure 3-16. GAS CAL MenuThe following menu options are provided in this menu:•ZERO CAL. Selecting this menu option will cause themonitor to perform a Zero Cal of the Agent System.•SPAN CAL. When the Agents option is installed, selectingthis menu option will bring up a password entry boxrequiring a five (5) digit service code to access theAnesthetic Agent Span Cal Service Menu.•O2 CAL. Selecting this menu option will cause the monitorto perform a one (1) minute calibration of the O2 Sensor.•O2 INIT CAL. Selecting this menu option will cause themonitor to perform a two (2) minute calibration of the O2Sensor. This calibration should be performed after everyreplacement of the O2 Sensor.•GAS MONITOR. Selecting this menu option brings up theGas Monitor Calibration Box. This box contains AgentSensor Calibration characteristics which are used for factorycalibration.•RETURN. Selecting this menu option returns the monitorto the SERVICE (BIO-MED) Menu.(e) MONITOR CAL. This menu option is intended for qualified ServicePersonnel only. Selecting this menu option will first bring up a Yes/Noselection screen (See Figure 3-17) to ensure that this menu was notselected by accident. When Yes is selected a second screen withCalibration Information on various operational aspects of the monitorappears (See Figure 3-18).• If this display should be selected, exit by turning themonitor off.
3-18• It is important to note that if the Escape option is selected,the monitor will return control of the monitor to the operatorbut the Calibration Screen will remain on the display; toremove the Calibration Screen turn the monitor off. Figure 3-17. Monitor Calibration YES/NO Menu Figure 3-18. Monitor Calibration Information Screen
3-19 Figure 3-19. System Configuration Menu(f) SYSTEM CONFIG. The SYSTEM CONFIG Menu (See Figure 3-19) is brought up by selecting the SYSTEM CONFIG Menu option.Most of the options in this menu are sensitive and are, as a result,protected by a five (5) digit password that must be entered before theoption may be adjusted. The Language and Pressure Unit options arethe only options in this menu which do not require that the service codebe entered.The following options are available in this menu:•ECG 1: Selecting this menu option will enable/disable theECG 1 module.•ECG 2: This option is not available on the 3160 MRIPhysiological Monitoring System.•NIBP: Selecting this menu option will enable/ disable theNIBP module.•P1: This option is not available on the 3160 MRIPhysiological Monitoring System.•P2: This option is not available on the 3160 MRIPhysiological Monitoring System.•P3: This option is not available on the 3160 MRIPhysiological Monitoring System.•P4: This option is not available on the 3160 MRIPhysiological Monitoring System.•SPO2: Selecting this menu option will enable/disable theSpO2 module.•EtCO2: Selecting this menu option will enable/disable theEtCO2 module (if installed).•RESP: This option is not available on the 3160 MRIPhysiological Monitoring System.•TEMP 1 AND 2: This option is not available on the 3160MRI Physiological Monitoring System.•AUX: This option is not available on the 3160 MRIPhysiological Monitoring System.
3-20•CO: This option is for future service enhancement.•RECORDER: Selecting this menu option will enable/disable the RECORDER module.•CS COMM: Selecting this menu option will enable/disableCS COMM.•PARALLEL PORT: Selecting this menu option willenable/disable the Parallel/Printer Port.•ANALOG OUTPUT: Selecting this menu option willenable/disable the Analog Output Port.•NETWORK: Selecting this menu option provides amethod of connecting to a specific network.•ST-SEGMENT: This option is not available on the 3160MRI Physiological Monitoring System.•LINE FREQUENCY: Selecting this menu option switchesthe ECG Notch Filter between 50 Hz and 60 Hz. This filterdoes not apply to ECG Diagnostic Filter Mode.•LANGUAGE: Selecting this menu option allows theLanguage of the monitor to be switched between theavailable languages (English, German, Spanish, Portuguese,Italian, Dutch, Swedish and French). To enable the languagechange, the operator must exit the SYSTEM CONFIGmenu by selecting Return or pressing the NORMALSCREEN control key, and then turn the monitor Off thenOn.•PRESSURE UNITS: Selecting this menu option allows theBlood Pressure and EtCO2 Measurement units to beswitched between mmHg and kPa. See Appendix E for akPa to mmHg Conversion Chart.•MONITOR MODE: This menu item is set automaticallydepending on which unit is be looked at. For the DCU, thisoption is set to REMOTE MODE. For the WPU, this optionis set to LOCAL MODE.•RETURN: Selecting this menu option returns the monitorto the Service (Bio-Med) Menu.(g) RETURN. Selecting this menu option returns the monitor to theSETUPS Menu.(8) Return. Selecting this menu option returns the monitor to the Normal Screen.3.3 Store/Recall Setups. (DCU Only) The 3160 MRI Physiological Monitoring System hasseven (7) memory blocks, each of which has enough capacity for the current setting of every controlsetup, alarm limits, trend time base, etc. on the monitor. The operator is able to store and recall sevendifferent configurations of the monitor. The seventh (USER DEFAULTS) is also used for recall atmonitor power up. The memory blocks are maintained by a long-life battery, or static RAM memory,which will keep the memory contents intact even when power is off.Settings for the monitor can be stored for different procedures, different types of patients, etc., or multi-ple users of the monitor can store and recall their own preferred configurations without having to indi-vidually set each limit, status, etc., before each use.Each storage memory block maintains the settings for:a. ALARMS. The setting of MIN and MAX values. auto-set percentage, latched ornon-latched selection for alarms, and alarm tone enabled/disabled.b. SYSTEM SETUPS. All Settings.
3-21c. ECG. Selected lead, scale setting, trace speed, filter mode, QRS tone ON/OFF andheart rate source.d. RECORDER. Off or auto, trace delay, recorder speed and the selected traces.e. NIBP. Manual, off or auto and the automatic time interval.f. EtCO2. Size, grids and flow.g. TREND GRAPHS. Time bases and scales.h. SpO2. Size.Once the monitor is setup properly, the setups may be stored in one of the available memory blocks.The stored setups can be brought up via the RECALL SETUPS Menu.3.4 Monitor Initialization. The monitor may start its monitoring functions from either an initial(Factory Settings) state or a pre-configured state depending on how the stored configurationinformation and patient data (trends, tabular data, and reports) are treated on start-up.3.4.1 Default Initialization. The monitor's master processor is "cold-started" by pressing andholding the Rotary Knob then the NORMAL SCREEN key while turning power on (See Paragraph2.3.1.g for further information). If the monitor is cold started, it will revert to Factory DefaultSettings. The screen displays the following:a. The Bell Symbol with “H” in it appears in the upper portion of the screen underALARM STATUS.b. ECG 1 is on in Trace A and set to Lead II.c. SpO2 is on with waveform displayed in Trace C.d. NIBP is on and displayed in the lower left portion of the screen.e. The “SOUND ON HOLD” message is displayed in the center of the screen and countsdown starting from 180.f. All other parameters are off.g. The alarm sound is enabled when the SOUND ON HOLD count reaches 0.3.4.2 Pre-Configured Initialization. A “warm-start” occurs whenever the monitor power is cycled(turned off then back on).
4-1SECTION 4PATIENT PARAMETERS4.0 PATIENT PARAMETERS.4.1 ECG Monitoring. Unless it has been turned off in the ECG Menu, the selected ECG lead isdisplayed as TRACE A. Most ECG functions are contained in the ECG Menu. Additional featuresuseful with ECG monitoring are found in three secondary menus:•RECORDER Menu. Used to select all recorder functions and to set the recorderand trace speed.•ALARMS Menu. Used to set and/or disable the ECG alarms. The range of AlarmLimits for the ECG Heart Rate is 30 to 249 bpm.•HEART RATE Trend Menu. Used to setup and print Trended information.For further information on the secondary menus, see the corresponding paragraphs of thisdocument.4.1.1 Patient and Lead Preparation. Acquisition of the patient's ECG signal is achieved with aInvivo approved patient cable with the appropriate lead wires and electrodes. Patient skin preparation,type of electrode used, and technique used to apply electrodes are major factors that can affect thequality of tracing displayed on the monitor. To obtain a tracing with baseline stability and to reduceartifact due to patient movement the following guidelines should be followed.a. Patient Skin Preparation. Prepare the patient's skin as follows:• Shave hair from electrode placement sites.• Cleanse skin thoroughly to remove skin oil, or any other substance that canincrease impedance (avoid using alcohol as it tends to overdry the skincausing flaking which increases impedance). For best results use InvivoSkin Prep #9009.• Gently abrade the skin with gauze or rough material to remove dry skin.b. Electrodes. Check the electrodes for the following:• Use electrodes of the same type/brand to ensure consistent impedancelevels.• Ensure electrodes do not exceed the expiration date.• Ensure that the conduction gel is moist to the touch.c. Electrode Placement. Place the electrodes as follows:• Attach electrodes to the lead wires prior to placing on the patient.• Place black electrode on left shoulder under left clavicle.• Place white electrode on right shoulder under right clavicle.• Place red electrode on lower left abdomen under the sixth rib.• Place the green electrode on the lower right abdomen under the ribs.d. Attaching the ECG Cable. Attach the ECG cable to the ECG Patient Connector onthe WECG telemetry transmitter. Figure 4-1. ECG Trace and Numerical Displays
4-24.1.2 Associated Waveforms and Displays. (See Figure 4-1) ECG information is displayed as awaveform in the Trace A location and as numeric data in the Box 1 and 2 locations. The following is adescription of the items contained within the ECG Display.a. ECG Lead. (Item 1) Displays the ECG Lead selected for use.b. Scale Indicator. (Item 2) This indicator is provided for a reference and represents a 1millivolt signal amplitude.c. Message Areas. (Item 3) These areas display software messages: the area on the leftdisplays ECG specific messages while the larger area on the right displays all types ofmonitor messages.d. Waveform Traces. (Item 4) Displays the ECG waveform of the patient.e. Heart Rate Numeric. (Item 5) Displays the current Heart Rate indication for thepatient.f. Alarm Limit High. (Item 6) Displays the value set for the High Limit of the ECGHeart Rate Alarm. This istem is under operator control and may be turned on or off asrequired.g. Alarm Limit Low. (Item 7) Displays the value set for the Low Limit of the ECGHeart Rate Alarm. This item is under operator control and may be turned on or off asrequired.h. Heart Rate Source. (Item 8) Displays the source selected for the Heart Rate. Figure 4-2. The ECG Menu4.1.3 The ECG Menu. (See Figure 4-2) Selecting the ECG Menu-Select Icon brings up the ECGMenu. This menu has a time-out feature. If no action is taken for approximately 60 seconds, themonitor will automatically return to the Normal Screen.The following selections are available in the ECG Menu:a. TRACE A LEAD. Selecting this menu option allows the selection of the ECG 1 lead.The options are II (default) and OFF.b. TRACE B LEAD. This option is not available on the 3160 MRI PhysiologicalMonitoring System.
4-3 Figure 4-3. The ECG SCALE Sub-Menuc. SCALE. Selecting this menu option allows the selection of the scale for the ECGwaveform(s). The options are AUTO, 1, 5, 10, 15 (default), 20, 25, 30, and 40 mm/mv(See Figure 4-3). The selected scale appears on the right hand side of this menu option.If AUTO is selected, a scale is picked that would make the current waveform(s) fill theECG viewing area. This scale will be in effect until another scale is selected (AUTO orany other selection). A Scale Indicator associated with the Trace is displayed on the leftside of the screen, and denotes a 1 millivolt signal amplitude.(1) If the scale of the ECG trace is so large that the top or bottom of the ECGwaveform is distorted or flattened, the “OVERSCALE” message flashes inthe ECG waveform area. This message will override other ECG errormessages. Use the SCALE menu option (in the ECG Menu) to resize thewaveform until the “OVERSCALE” message stops flashing. If this continues,the Auto Scale option should be selected to prevent further waveformdistortion.(2) The ECG waveform in may be frozen for closer examination by pressing theFREEZE control key. When the waveform is frozen, it is displayed belowTrace A with a “Blue Box” around it. While Freeze is enabled, changes to theParameter Selections are not allowed; if the operator tries to access thePARAMETER SELECTION menu, a WARNING Box appears to alert theoperator that the selected menu may not be accessed.d. HR SOURCE. Selecting this menu option allows the selection of the source to be usedfor the heart-rate display in TRACE A area. The options are AUTO, ECG (default),ART, SPO2 and NIBP (See Figure 4-4).NOTEInvasive Pressure is not available with this system. If ART is selected as the HR SOURCE aWarning box appears that informs the operator that this option is not available.
4-4 Figure 4-4. The ECG HR SOURCE Sub-Menu(1) The heart rate is displayed in the ECG parameter box. It is annotated with itssource (e.g., “60 ECG” indicates a heart rate of 60, derived from ECG).(2) If AUTO is chosen, the heart rate is selected automatically from thehighest-priority active input. When set to AUTO the 3160 Vital SignsMonitoring System searches for another source for rate only when LEADFAIL occurs or the ECG parameter is turned OFF. The priority, from highestto lowest, is ECG, SpO2, and NIBP.(3) The 3160 Vital Signs Monitoring System examines the highest-priorityactive input. If not found, it will go to the next-highest priority parameter. Ifnone of the parameters are presenting a heart rate and NIBP is shut off, then“NONE” is displayed on the screen in the heart rate position.(4) HR Tone Source is only set for ECG or SpO2.(5) This menu option is identical to, and interactive with, the similarly namedmenu options under SPO2 and NIBP.e. HR TONE SRCE. Selecting this menu option selects the source to be used for theheart-rate tone. The options are QRS, SPO2 and OFF (default). When this parameter isset to OFF, the Heart Symbol will not be displayed.(1) When the SpO2 parameter provides the heart rate tone, the tone is modulatedby the SpO2 value.(2) If the Heart Rate Tone source is turned off, the Heart Symbol is removed fromthe display.(3) This menu option is identical to, and interactive with, the HR TONE SOURCEoption in the SOUND ADJUST Menu.f. FILTER MODE. Filter Mode is permanently set to MON (monitor) with bandwidthof 0.5 to 40 Hz.g. CAL. Selecting this menu option opens the CALIBRATE Menu. This menu option isidentical to and interactive with the calibrate option in the RECORDER Menu. Thefollowing options are available in the CALIBRATE Menu:
4-5(1) OFF. Selecting this menu option turns the Calibration feature OFF.(2) RECORDER. Selecting this menu option sends a 1mV pulse calibrationwaveform to the ECG Vital Sign and will also be the ECG waveform printedby the recorder if so configured. The message CAL is displayed over the ECGwaveform on the screen.(3) ECG. Selecting this menu option sends a 2mV peak to peak (1mV peak)calibration signal to the ECG vital sign and will also be the ECG waveformprinted by the recorder if so configured. The message CAL is displayed overthe ECG waveform on the screen. It is important to note that this is a hardwaregenerated calibration waveform and originates as a square wave.(4) RETURN. Selecting this menu option closes the CALIBRATE Menu.h. RETURN. Selecting this menu option will return the monitor to the Normal Screen.4.1.4 Alarm Limits. Alarm Limits may be set two ways. To set the Alarm Limits for everyavailable parameter, from the Normal Screen (with no icons highlighted), press the ALARMSSCREEN Menu-Select Key. To set the Alarm Limits for ECG Heart Rate only, highlight the ECGIcon and press the ALARMS SCREEN Menu-Select Key to access the individual parameter AlarmLimits Box. The range of Alarm Limits for the ECG Heart Rate is 30 to 249 bpm.4.1.5 Trended Data. For complete information on the trending of patient ECG data, see Section 5:Printing and Trending.4.1.6 ECG Messages. The following is a list of messages that may be displayed during ECGmonitoring:4.2 Non-Invasive Blood Pressure (NIBP) Monitoring. The NIBP feature measures anddisplays systolic, diastolic and mean arterial pressures, and pulse rate. LOW and HIGH Alarm Limitsare available for all three pressures. When the 3160 Vital Signs Monitoring System is configured toobtain the patient's heart rate from the NIBP, the heart rate alarm is also applicable to this parameter.The monitor may be set to take NIBP readings at automatic intervals from 1 to 240 minutes (there is a20 second pause between readings to allow for peripheral perfusion), or the operator can manuallyinitiate a reading at any time.When a successful reading is taken, the elapsed time display indicates the beginning of this cycle.The time until next measurement indicates when the next automatic measurement will be made. Amanual reading does not restart this cycle time. The NIBP INTERVAL key may be used toadjust the cycle time. The NIBP START/STOP key may be used to manually start/stop ameasurement. The NIBP STAT key allows the start of STAT Mode (which makes up to five (5)NIBP determinations in rapid succession).If an error is detected, the Alarm Tone will sound, and an error message will be written on thescreen.Non-Invasive blood pressure monitors are sensitive to patient motion artifact. Such artifact cancause readings to be slow or even an incorrect pressure reading.Visual checks of the patient, other vital signs and checking the limb to which the cuff is attachedshould be standard routines with NIBP use.LEAD FAIL LEAD FAIL is displayed when a faulty ECG Lead is detected by thesystem.OVERSCALE OVERSCALE is displayed if the scale of the ECG Trace is so largethat the tops of the ECG waveforms are being “clipped” (the tops andbottoms cut off). This message suppresses all other ECG ErrorMessages and the Alarm Tone will not sound. To reduce the scale,and remove the OVERSCALE message, access the SCALE menuoption in the ECG Menu.
4-6If a measurement is in progress and communication is lost between the DCU and WPU, themeasurement is aborted.Most NIBP functions are contained in the primary NIBP Menu. However, additional featuresuseful with NIBP monitoring can be found in the three secondary menus associated with thisparameter:•RECORDER Menu. Used to select recorder functions and to set the recordertrace speed.•ALARMS Menu. Used to set and/or disable the NIBP alarms. The range of AlarmLimits for the NIBP is 5 to 249 mmHg.•NIBP Trend Menu. Used to setup and print Trended information.4.2.1 Theory of Oscillometric Measurement. This monitor obtains blood pressure measurementsbased on the Oscillometric principle. Oscillometric Monitors use an inflatable occlusive cuff whichcan also be used in the manual auscultatory technique; however, rather than monitoring Korotkoffsounds, Oscillometric Monitors detect and measure oscillations induced in the cuff by the movementof the arterial wall. In basic terms, oscillometric monitors utilize a pressure transducer which isconnected to the cuff via a hose. The transducer transforms the oscillations induced into the cuffpressure into electrical currents. Under control of a microprocessor and software algorithms, theelectrical current can then be measured and correlated with the cuff pressure to determine arterial bloodpressure. The following describes the process of Oscillometric Measurement: Figure 4-5. Oscillometric Measurement Methoda. As the occlusive cuff is inflated to a suprasystolic pressure the artery is occluded so thatno blood passes through. At this point, even though no blood flows under the cuff,there are small pulsations induced into the cuff pressure by the partially-occludedproximal portion of the artery lying under the cuff (See Figure 4-5).b. As cuff pressure is reduced to just below the systolic pressure, the force of the height ofthe systolic pressure wave forces the occluded artery open, blood spurts through theartery and the amplitude of the oscillations increase sharply. This is the systolicpressure.c. With further reduction in cuff pressure the artery opens for a longer time during eachcardiac cycle, which causes increasingly larger oscillations in the cuff pressure untilthey reach a point of maximum oscillation amplitude. This point of maximumoscillations has been well-demonstrated to be Mean Arterial Pressure.d. With continued cuff-pressure reduction, the underlying artery is open throughout thecardiac cycle, and the arterial-wall movement is less. The cuff pressure oscillationsbegin to decrease in amplitude until they become uniform. The point at which theamplitudes become uniform is diastolic pressure.NOTEThe point of maximum oscillations is coincident with mean arterial pressure regardless of arterialelasticity so long as the ratio of air volume in the cuff to the volume of the artery under compressiondoes not greatly exceed ten (10) to one (1). For this reason it is advisable to keep the cuff air volumeto a minimum by using the smallest cuff size possible for each patient.
4-74.2.2 Patient and Cuff Preparation. The patient should remain calm and motionless while themonitor is being used. If the patient is overactive, prolonged or inaccurate readings may result.Perform the following to prepare the patient and cuff for monitoring:a. Cuff Selection. The cuff is selected and positioned as it would be for an auscultatoryblood pressure determination, and the current guidelines of the American HeartAssociation should be followed. The bladder width of the cuff should be 40% of thecircumference of the limb. For a correct fit on adult and pediatric cuffs, the Index lineon the end of the cuff must fall between the two Range lines printed on the inside of thecuff. For correct fit on neonatal cuffs, choose the size with the stated circumferencerange that fits the circumference of the limb of the neonate.b. Cuff Positioning. The cuff should be wrapped firmly (not snug) around the arm of thepatient and positioned as close to heart level as possible. If the cuff is not at heart level,add 1.8 mmHg to the displayed readings for each inch that the center of the cuff islocated above the patient's heart level; subtract 1.8 mmHg from the displayed readingsfor each inch that the cuff is located below the patient's heart level.c. Cuff Connections. Select the proper hose (twin-lumen for adults, single-lumen forneonates), and attach hose to cuff. Route the hose from the cuff to the monitor so it doesnot kink, tangle or limit access to the patient. Figure 4-6. The NIBP Display4.2.3 Associated Displays. When NIBP is enabled, it is displayed in a box at the lower left of thenormal screen. The box is a specialized display panel that includes the information concerning theNIBP status in one of two user selectable formats. The two available formats are Systolic/Diastolic andMean Only (See Figure 4-6); the user selects the format using the FORMAT option in the NIBPMenu (See Paragraph 4.2.5). The two available displays are described below:a. The NIBP Systolic/Diastolic Display. The items contained in this user selectabledisplay are described below:(1) Icon Label. (Item 1) This label identifies the parameter whose numeric data isbeing displayed within the Icon Box. Box 11 (in the lower left of the BottomNumeric Display) is dedicated to the display of NIBP information.(2) Manual. (Item 2) While in the Automatic Mode, “NEXT” is shown and thetime until the next NIBP determination is displayed here; in the Manual Mode,the word “MANUAL” is displayed here.(3) Mean Numeric. (Item 3) A numeric indication of the patient's Mean pressurereading.(4) Systolic Numeric. (Item 4) A numeric indication of the patients NIBPSystolic reading.WARNINGDo not attach the cuff to a limb being used for infusion. Cuff inflation can block the infusion causingpossible harm to patient.
4-8(5) Diastolic Numeric. (Item 5) A numeric indication of the patients NIBPDiastolic reading.(6) Diastolic Alarm Limits. (Item 6) A numeric indication of the settings of theHigh (to the left in the example) and Low (right in the example) DiastolicAlarm Limits.(7) Systolic Alarm Limits. (Item 7) A numeric indication of the settings of theHigh (to the left in the example) and Low (right in the example) Systolic AlarmLimits.(8) Unit of Measurement. (Item 8) Displays the Unit of Measurement being usedfor presentation of the numeric data. This item may be toggled between mmHgand kPa using the System Configuration Menu (See Section 3 for furtherinformation).(9) ET. (Item 9) The Elapsed Time (ET) since the last NIBP determination isdisplayed here. During an NIBP determination, this message changes todisplay the cuff pressure.b. The NIBP Mean Display. The items contained in this user selectable display aredescribed below:(1) Icon Label. (Item 1) This label identifies the parameter whose numeric data isbeing displayed within the Icon Box. Box 11 (in the lower left of the BottomNumeric Display) is dedicated to the display of NIBP information.(2) Manual. (Item 2) While in the Automatic Mode, “NEXT” is shown and thetime until the next NIBP determination is displayed here; in the Manual Mode,the word “MANUAL” is displayed here.(3) Systolic/Diastolic Numeric. (Item 3) A numeric indication of the patient'sSystolic/Diastolic pressure reading.(4) Mean Numeric. (Item 4) A numeric indication of the patients NIBP Meanreading.(5) Mean Alarm Limits. (Item 5) A numeric indication of the settings of the High(on top in the example) and Low (bottom in the example) Mean Alarm Limits..(6) Unit of Measurement. (Item 6) Displays the Unit of Measurement being usedfor presentation of the numeric data. This item may be toggled between mmHgand kPa using the System Configuration Menu (See Section 3 for furtherinformation).(7) ET. (Item 7) The Elapsed Time (ET) since the last NIBP determination isdisplayed here. During an NIBP determination, this message changes todisplay the cuff pressure. Figure 4-7. The NIBP Menu
4-94.2.4 The NIBP Menu. Selecting the NIBP Menu-Select Icon will bring up the NIBP Menu (SeeFigure 4-7). This menu provides the operator with the ability to switch the Automatic Mode On andOFF, set the automatic reading interval, set the Heart Rate source and bring up a Tabular Chartcontaining a History of the NIBP and SpO2 determinations. This menu has a time-out feature. If noaction is taken for approximately 60 seconds, the monitor will automatically return to the NormalScreen.4.2.5 NIBP Menu Options. The following is a description of the operation of the NIBP Menuoptions: Figure 4-8. The NIBP INTERVAL Menua. INTERVAL. Selecting this menu option allows the operator to change theautomatic-measurement time interval setting (See Figure 4-8). The options are 1, 2,2.5, 3 (default), 5, 10, 15, 20, 30 or 45 minutes, and 1, 2 or 4 hours. The INTERVALMenu is also accessed by pressing the NIBP INTERVAL key.(1) There is a 20-second period in between the measurements to allow forperipheral perfusion.(2) As the Rotary Knob turns clockwise, the interval selection will increase. Afterreaching “RETURN,” the interval selection will “roll over” to “1 MIN” andcontinue to increase.(3) As the Rotary Knob turns counter-clockwise, the interval selection willdecrease. After reaching “1 MIN,” the interval selection will “roll over” to“RETURN” and continue to decrease.b. AUTO MODE. Selecting this menu option allows the operator to switch the NIBPAutomatic Mode between ON and OFF (default). When switched from OFF to ON,the operator must manually initiate the first reading (by pressing the NIBP START/STOP control key); subsequent readings are taken automatically at the operatorselected interval. When in MANUAL mode, readings may only be initiated from theNIBP START/STOP or NIBP STAT control keys. A reading cycle may be stoppedat any time if the NIBP START/STOP control key is pressed while it is in progress
4-10c. HR SOURCE. Selecting this menu option allows the selection of the source to be usedfor the heart-rate display in the ECG area. The options are AUTO, ECG (default), ART(arterial pressure), SPO2 and NIBP.This menu option is identical to, and interactive with, similarly named menu optionsunder ECG and SPO2. Figure 4-9. The HISTORY Menud. HISTORY. Selecting this menu option brings up the HISTORY Menu (See Figure4-9), and displays the last 48 NIBP readings together with the heart rate, SpO2, CO2and respiration values at the time in a tabular form (6 readings per page). The tabulardata is retained in non-volatile memory when power is interrupted.The following options are available in the HISTORY Menu:(1) PRT ALL. Selecting this menu option prints all stored Tabular Data.(2) PRT PAGE. Selecting this menu option prints the current page.(3) PREV PAGE. Selecting this menu option allows the selection of the previouspage of tabular data.(4) NEXT PAGE. Selecting this menu option allows the selection of the nextpage of the tabular data.(5) CLEAR ALL. Selecting this menu option clears the patient Trend Data.(6) RETURN. Selecting this menu option will return the monitor to the NIBPMenu.e. FORMAT. Selecting this menu option allows the operator to change the displayformat of the Pressure numerics. If SYS/DIA is selected, the Systolic and Diastolicnumerics will be in a large font separated by a “slash” and the Mean numeric will be ina smaller font bracketed with parenthesis. If MEAN is selected, the Mean numeric isdisplayed in the large font with the Systolic and Diastolic numerics separated by a“slash” in a smaller font.f. RETURN. Selecting this menu option will return the monitor to the Normal Screen.NOTEInvasive Pressure is not available with this system. If ART is selected as the HR SOURCE aWarning box appears that informs the operator that this option is not available.NOTEHistory Data is retained when a new patient is connected to the monitor. Therefore, to avoidconfusion, all previously acquired data should be cleared prior to connection to a new patient.
4-114.2.6 Using the Automatic Interval Mode This monitor may be setup to take NIBP readingsautomatically at intervals set by the operator. To set this monitor to make automatic NIBPdeterminations, turn the Rotary Knob until the NIBP Menu-Select Icon is highlighted and then pressthe Rotary Knob to bring up the NIBP Menu. To set the Interval Time, highlight the INTERVALmenu selection and press the Rotary Knob to access the time selection menu. To turn the AutomaticMode of Operation ON or OFF, highlight the AUTO MODE menu selection, press the Rotary Knoband select ON or OFF. Once the Automatic Mode has been turned On, press the NIBP START/STOPControl Key to activate.4.2.7 Manually Starting/Stopping a Reading Cycle An NIBP cycle may be started or stopped bypressing the NIBP START/STOP Control Key.4.2.8 Stat Mode Operation The STAT Mode is specifically intended for clinicians who need toobtain successive readings for rapid assessment of the trend of a patient's pressures. To initiate a seriesof up to five STAT Readings, the operator presses the NIBP STAT Control Key. The monitor willperform up to five NIBP cycles in a period of five (5) minutes. At the end of the five (5) minute period,the STAT Mode will terminate (even if a reading is in progress) regardless of how many readings havebeen completed.4.2.9 Alarm Limits Alarm Limits may be set two ways. To set the Alarm Limits for every availableparameter, from the Normal Screen (with no icons highlighted), press the ALARMS SCREEN Menu-Select Key. To set the Alarm Limits for NIBP only, highlight the NIBP Icon and press the ALARMSSCREEN Menu-Select Key to access the individual parameter Alarm Limits box. The range of AlarmLimits for the NIBP pressure channels is 5 to 249 mmHg.4.2.10 Adult vs. Neonatal Mode Operation This monitor allows the operator to determine pressureson a wide range of patients by allowing the Patient Type to be switched from Adult to Neonate (AdultMode is used for Adult and Pediatric patients and Neonate Mode is used for Neonates only). Severaloperational parameters (including cuff inflation pressure) are varied depending on the setting of thePATIENT menu option in the SETUPS Menu. The Adult/Pediatric Mode uses a higher pumpvolume and a much larger cuff is used on the patient; in the Neonatal Mode the pump rate is lower anda much smaller cuff is used on the patient (reference pages xvii, xviii and xix of this manual for cuffselection and sizes). The Alarm Limits and settings may also change when the patient type is switchedfrom adult to neo (or neo to adult).Whenever the NIBP Patient Mode is switched (either from Adult to Neo or Neo to Adult), for20 seconds the Alarm Tone will sound while the informational display message area indicates“Change NIBP Cuff.” To change the patient type, press the SETUP control key, scroll to thePATIENT menu selection and press the Rotary Knob. The “WRONG CUFF” NIBP messagewill appear if a reading is initiated and the monitor detects that an incorrect cuff is being used forthe selected patient mode (Adult or Neonate). Replace the patient cuff with the appropriate sizecuff and press the NIBP START/STOP control a second time, this will re-initiate the reading.4.2.11 Trended Data. For complete information on the trending of patient NIBP data, see Section 5:Printing and Trending.WARNINGThe patient's blood pressure determinations are not continuous. The blood pressure determinationsare only updated immediately after a blood pressure measurement is taken. When set to the shortestof the automatic intervals, the constant measurements can cause blood pooling in the limb, andblood pooling in the limb may artificially increase the value of the blood pressure determinations.WARNINGThe initial cuff inflation pressure will increase to 170 mmHg when changing the patient mode fromNeonate to Adult.
4-124.2.12 NIBP Messages. The following is a list of messages that may be displayed during NIBPmonitoring:4.3 SpO2 Monitoring. The SPO2 Menu is brought up (if this parameter is turned on through theSETUPS Menu) with the SPO2 Menu-Select Icon.The following three secondary menus support the SpO2 monitoring feature:•RECORDER Menu. Used to select recorder functions and to set the recorder andtrace speed.•ALARMS Menu. Used to set and/or disable the SpO2 alarms. The range of AlarmLimits for SpO2 is 50 to 99%, Off.•SpO2 Trend Menu. Used to setup and print Trended information.4.3.1 Sensor Positioning. The monitoring site, sensor position, sensor connection and the ambientenvironment all have possible impacts on the operation of this monitor. The following is a list ofpossible messages (which are indicated in the SpO2 display), their causes and possible solutions:a. LOW LIGHT. The transmission of the light is partially blocked. The tissue at the sitemay be too opaque and/or thick. If the sensor is positioned on the finger, check thefingernails for nail polish, long fingernails and artificial fingernails; remove fingernailpolish completely, for artificial nails: use a Multi-Site sensor at another location, and,for long fingernails: either trim the nails or use a Multi-site sensor at another location.CALIB Displayed if the monitor detects an out of range DC Offset.CHANGE NIBP CUFF Displayed for 30 seconds whenever the Patient Mode isswitched between Adult and Neonate.CUFF LEAK Displayed if the monitor detects a leak in the cuff during thelast reading attempt. This message is also displayed, withother messages, between reading attempts to provide avisual indication that a leak was detected in the cuff duringthe previous reading attempt.CUFF=XXX Displayed while the monitor is making an NIBPdetermination. Provides a visual indication of the actualpressure of the cuff throughout the measurement.ET=XXX Indicates the time since the last NIBP measurement wascompleted.LONG PRESS Displayed if the monitor detects Cuff Pressure remainingthe same for more then 30 seconds or if a reading has beenin progress for more than 150 seconds for adults (80seconds for neonates).NOT INFLATING Displayed if the monitor detects the Cuff Inflation Cyclerunning longer than 30 seconds for adults (6 seconds forneonates).OVER PRES Displayed if the monitor detects a Cuff Pressure of 285mmHg (adult, 150 neonate) or higher.RESIDUAL PRES Displayed if the monitor detects that Cuff Pressure remainsabove 20 mmHg for more then 2.5 minutes.WRONG CUFF Displayed if the monitor detects that an incorrect Cuff isbeing used. Select the appropriate cuff for the patient.
4-13b. PROBE OFF. The sensor is not sensing or detecting the patient's pulse. There are twopossible causes of this, either the sensor is not detecting the pulse or the sensor isreceiving too much light to operate. Check the ambient lighting, if a light is shiningdirectly into the sensor, reposition the sensor to a darker area or cover the sensor to cutdown the light entering the sensor. Check the sensor cable connection for properconnection. Try a different sensor.c. HIGH LIGHT. There is too much light passing through the tissue at the presentsensor site. Move the sensor to an area with thicker tissue.d. SEARCHING. The monitor is searching for a good pulse. Give the monitor time tolock onto a good pulse.e. LOW QUAL. The signal correlation between the red and infrared light channels is toolow for accurate saturation calculation. Contact Invivo Technical Service for furtherassistance. Figure 4-10. SpO2 Display4.3.2 Associated Waveforms and Displays (See Figure 4-10) If the SpO2 is turned on thewaveform is displayed in Trace Location C and the numerical information in Box 2. The following is adescription of the items contained within the SpO2 Display:a. SpO2 Waveform. (Item 1) The SpO2 Waveform is displayed in Trace Location C.b. Icon Label. (Item 2) This label identifies the parameter numerics that are displayedwithin this box. SpO2 is monitored using Box 3.c. SpO2 Numeric. (Item 3) A numeric indication of the patient's SpO2 reading.d. SpO2 High and Low Alarm Limits. (Item 4) A numeric indication of the settings ofthe High and Low SpO2 Alarm Limits.e. Heart Rate. (Item 5) Heart Rate Value derived from SpO2.4.3.3 SpO2 Menu (See Figure 4-11) The menu for the SpO2 is brought up with the selection of theSPO2 Menu-Select icon. This menu has a time-out feature. If no action is taken for approximately60 seconds, the monitor will automatically return to the Normal Screen. Figure 4-11. The SpO2 Menu
4-14The following is a description of the SPO2 Menu options:a. SIZE. (See Figure 4-12) Selecting this menu option provides the operator with theability to change the size of the SpO2 pulse waveform. The options are 10%, 20%,40% (default), 60%, 80% and 100%. Figure 4-12. The SpO2 SIZE Menub. HR SOURCE. Selecting this menu option allows the selection of the source to be usedfor the heart-rate display in the ECG area. The options are AUTO, ECG (default), ART(arterial pressure), SPO2 and NIBP.This menu option is identical to, and interactive with, similarly named menu optionsunder ECG and NIBP.c. HR TONE SRCE. Selecting this menu option selects the Heart Rate tone source. Theoptions are QRS, SPO2 and OFF (default). When the source is the QRS, the tonesounds at the detection of QRS from the ECG parameter. When the source is the SpO2,the tone sounds at the detection of the pulse from the SpO2 parameter.The pulse tone is modulated by the SpO2 value. The pitch will be at the lowestfrequency when its value is at the low end of scale.This menu option is identical to, and interactive with, the HR TONE SOURCE optionin the SOUND ADJUST and ECG Menus.d. RETURN. Selecting this menu option will return the monitor to the Normal Screen.4.3.4 Alarm Limits. Alarm Limits may be set two ways. To set the Alarm Limits for every availableparameter, from the Normal Screen (with no icons highlighted), press the ALARMS SCREEN Menu-Select Key. To set the Alarm Limits for SpO2 only, highlight the SpO2 Icon and press the ALARMSSCREEN Menu-Select Key to access the individual parameter Alarm Limits Box. The range of AlarmLimits for SpO2 is 50 to 100%.4.3.5 Trended Data. For complete information on the trending of patient SpO2 data, see Section 5:Printing and Trending.4.3.6 SpO2 Messages. The following is a list of messages that may be displayed during SpO2monitoring:NOTEInvasive Pressure is not available with this system. If ART is selected as the HR SOURCE aWarning box appears that informs the operator that this option is not available.BAD PROBE The monitor has sensed a shorted or open connector in the sensor.Contact Invivo Technical Service for further assistance.HIGH LIGHT There is too much light passing through the tissue at the presentsensor site. Move the sensor to an area with thicker tissue.
4-154.4 End-tidal CO2 (EtCO2) Monitoring. The EtCO2 Menu is brought up (if this parameter isturned on through the SETUPS Menu) with the EtCO2 Menu-Select Icon. The EtCO2 featureprovides side stream measurement of CO2 and mean N2O with a continuous real time CO2 WaveformDisplay. This feature will perform an automatic zeroing at periodic intervals while continuouslyperforming pressure corrections. EtCO2 monitoring also provides Respiration Monitoring.The following three secondary menus support the EtCO2 monitoring feature:•RECORDER Menu. Used to select recorder functions and to set the recorder andtrace speed.•ALARMS Menu. Used to set and/or disable the EtCO2 alarms. The range ofAlarm Limits for EtCO2 is 5 to 80 mmHg.•EtCO2 Trend Menu. Used to setup and print Trended information.4.4.1 Patient and Sampling Line Preparation. The accuracy of the data collected is greatlyinfluenced by the proper use, fitting and maintenance of the sampling tubing, moisture filters andpatient breathing apparatus.LOW LIGHT The transmission of the light is partially blocked. The tissue at thesite may be too opaque and/or thick. If the sensor is positioned on thefinger, check the fingernails for nail polish, long fingernails andartificial fingernails; remove fingernail polish completely, forartificial nails: use a Multi-Site sensor at another location, and, forlong fingernails: either trim the nails or use a Multi-site sensor atanother location.LOW QUAL The signal correlation between the red and infrared light channels istoo low for accurate saturation calculation. Contact Invivo TechnicalService for further assistance.PROBE OFF The sensor is not sensing or detecting the patient's pulse. There aretwo possible causes of this, either the sensor is not detecting the pulseor the sensor is receiving too much light to operate. Check theambient lighting, if a light is shining directly into the sensor,reposition the sensor to a darker area or cover the probe to cut downthe light entering the sensor. Check the sensor cable connection forproper connection. Try a different sensor.SEARCHING The monitor is searching for a good pulse. Give the monitor time tolock onto a good pulse.NO PROBE The monitor is not detecting a sensor connected. Check that thesensor is securely connected to the monitor. Try a different sensor.Hardware Failure The monitor has detected a hardware failure. Remove the systemfrom service immediately and refer it to Invivo qualifed servicepersonnel for repair. This monitor should not, for any patient thatrequires accurate SpO2 measurement, ever be placed back intoservice before the repair is performed.Wrong Probe The monitor has detected a probe type that is not compatable withthis system. Replace the probe with an Invivo approved probe.Remember to use only Invivo approved accessories with thismonitor.CAUTIONBefore using the EtCO2 analyzer, read the PRECAUTIONS and USER RESPONSIBILITIESwhich follow the Table of Contents.
4-16a. The patient sampling circuit (See Figure 4-13) consists of the sampling line and eithera sampling nasal cannula or a side stream adaptor connected to an endotrachealconnector. All fittings in the circuit are Luer-Lock type. All fittings should be fittedtogether securely to keep them from separating during the procedure, and to ensureproper sampling without the introduction of outside air. Loose fitting will result inGas measurement errors.b. Nasal Cannula. The nasal cannula is of the “around-the-ear” type. Place the nasalprongs gently inside the nose, loop the excess tubing over the patient's ears and thendown under the chin. The cannula may then be fitted by sliding the plastic ring up untilthe cannula is secure and comfortable.c. Endotracheal Adaptor. When using the endotracheal adaptor, attach the Nafion®Dryer Line before attaching the endotracheal adaptor to the endotracheal tube. Takegreat care not to dislodge or move the endotracheal tube when attaching the adaptor. Figure 4-13. The Patient Sampling Circuit Figure 4-14. Water Trap Installation Diagram
4-174.4.2 Water Trap Replacement. (See Figure 4-14) Remove the sample line from the Water Trapport and perform the following to replace the Water Trap:a. To remove the Water Trap: simultaneously press the two release tabs (located on theleft and right side of the trap near the top) and pull the Water Trap from the enclosure.b. To install the Water Trap: line the trap up with the enclosure (the enclosure is shaped tothe Water Trap) and press it into place until there is an audible “click” from both of therelease tabs.c. Attach sample line to Water Trap port. Figure 4-15. The EtCO2 Display4.4.3 Associated Waveforms and Displays (See Figure 4-15) EtCO2 information is displayed as awaveform in Trace Location D and as numeric data in Box 4. The following is a description of theitems contained within the EtCO2 Display:For best fit and compatibility, Invivo strongly recommends the use of the Invivo CO2 SamplingKit (Part No. 9010D), which contains all the above tubings and endotracheal tube adaptor.a. Inspired CO2 Numeric. (Item 1) A numeric indication of the patient's Inspired CO2reading.b. Respiration Waveform. (Item 2) The EtCO2 derived Respiration Waveform isdisplayed in Trace Location D.c. Icon Label. (Item 3) This label identifies the parameter numerics that are displayedwithin this box.d. EtCO2 Numeric. (Item 4) A numeric indication of the patient's EtCO2 reading.e. EtCO2 Alarm Limits. (Item 5) A numeric indication of the settings of the High (ontop in the example) and Low (bottom in the example) EtCO2 Alarm Limits.f. Unit of Measurement. (Item 6) Displays the Unit of Measurement being used forpresentation of the EtCO2 numeric data.CAUTIONDo not allow the tubing to become kinked so that the sample flow is reduced or cut off.Be careful that the tubing remains clear of any table moving mechanisms which may kink or cut thetubing.Always discard the Water Trap when it becomes filled. Do not attempt to clean or reuse the WaterTrap. Accidental water ingress into the monitor can affect the Gas measurements.Always inspect patient tubing after attachment to the monitor following the patient circuit’smanufacturer’s recommendations.WARNINGAlways test sampling line adapter for a tight connection and proper operation before attaching to apatient.Overtightening the sampling line may damage the water trap. Tighten the sampling line no morethan 1/4 turn.
4-18g. Unit of Measurement. (Item 7) Displays the Unit of Measurement being used forpresentation of the EtCO2 derived Respiration numeric data.h. Respiration Alarm Limits. (Item 8) A numeric indication of the settings of the High(on top in the example) and Low (bottom in the example) Respiration Alarm Limitswhen derived from the EtCO2 module.i. Respiration Numeric. (Item 9) A numeric indication of the patient's Respirationreading derived from the EtCO2 module.j. N2O Numeric. (Item 10) A numeric indication of the patient's N2O reading.4.4.4 EtCO2 Menu. (See Figure 4-16) The menu for the EtCO2 is brought up with the selection ofthe EtCO2 Menu-Select icon. This menu has a time-out feature. If no action is taken forapproximately 60 seconds, the monitor will automatically return to the Normal Screen.The following is a description of the EtCO2 Menu options:a. SIZE. Selecting this menu option brings up the SIZE Menu where the operator mayselect 40, 60 or 80 mmHg for the Scale Size of the EtCO2 Waveform Display.b. GRIDS. Selecting this menu option brings up the GRIDS Menu where the operatormay turn the EtCO2 Grids ON or OFF. Figure 4-16. The EtCO2 Menuc. ZERO CAL. Selecting this menu option causes the monitor to perform the ZeroCalibration routine.d. UNIT. Selecting this menu options brings up the UNIT Menu where the operator maytoggle the monitor between mmHg and kPa.e. RETURN. Selecting this menu option will return the monitor to the Normal Screen.4.4.5 Calibration of CO2/N2O Measurement System The monitor will perform automatic ZeroCalibration cycles as part of its normal function. The Zero Calibration cycle is discussed below.a. Zero Calibration Cycle. A Zero Calibration cycle consists of the realignment of theZero point. During this calibration, the monitor makes sure that a concentration of 0%is measured when room air is flowing through its sample chamber. During a ZeroCalibration cycle the unit performs the following steps:(1) Switches the input gas valve to the Zero Intake Port placed on the rear panel.(2) Room air is absorbed through the Zero Intake Port and flushes the pneumaticsystem for a few seconds.(3) Once the channel readings have stabilized, a snapshot is taken and the Zeropoint is realigned using these readings as a reference.(4) The Input Gas Valve is then switched back to the normal position and the gasbeing measured is given a few seconds to flush the pneumatic system to clearout the room air.
4-19(5) After the readings stabilize, the EtCO2 system begins it’s normal functioningroutine.b. Automatic Zero Calibration Cycles. An automatic Zero Calibration cycle istriggered when certain time intervals have passed since the monitor has completed itswarm-up cycle. The timetable for automatic Zero Calibration cycles is the following:2, 4, 6, 8, 10, 20, 40 and 60 minutes. After the first hour since warm-up, the monitorwill perform a Zero Calibration cycle every hour. In addition, event-related ZeroCalibration cycles are triggered when certain variations are noticed in the input signals(gases or temperatures). These events are: (1) A variation of 10% in the concentration of N2O.(2) A variation in the ambient temperature inside the unit box of 1°C.(3) A change in the ID of the current anesthetic agent (if Anesthetic Agents featureis available).(4) A change in the concentration of the currently measured anesthetic agent by2% volume (if Anesthetic Agents feature is available).(5) A variation in the concentration of the currently measured anesthetic agent by400% relative for concentrations in excess of 1% (if Anesthetic Agents featureis available).c. Operator Initiation of Zero Calibration. To manually initiate the Zero CalibrationRoutine, perform the following procedure:(1) Press the SETUP Control Key.(2) Highlight the SERVICE (BIO-MED) menu option and then press the RotaryKnob to select.(3) Highlight the GAS CAL menu option and then press the Rotary Knob to select.(4) Highlight the ZERO CAL menu option and then press the Rotary Knob toinitiate the Zero Calibration Routine.This option is identical to the ZERO CAL menu option in the EtCO2 Menu.4.4.6 Alarm Limits Alarm Limits may be set two ways. To set the Alarm Limits for every availableparameter, from the Normal Screen (with no icons highlighted), press the ALARMS SCREEN Menu-Select Key. To set the Alarm Limits for EtCO2 only, highlight the EtCO2 Icon and press theALARMS SCREEN Menu-Select Key to access the individual parameter Alarm Limits Box. Therange of Alarm Limits for EtCO2 is 5 to 60 mmHg and Off for the Low Limit and 5 to 80 mmHg andOff for the High Limit.4.4.7 Trended Data For complete information on the trending of patient EtCO2 data, see Section 5:Printing and Trending.4.4.8 EtCO2 Messages The following is a list of messages that may be displayed during EtCO2monitoring:NOTETo perform Zero Calibration, the monitor pulls ambient air through the rear panel CO2 Zero IntakePort. The Calibration system assumes that the ambient air will contain normal amounts of traceCO2. If this monitor is placed in an unventilated area that allows CO2 (from the rear panel CO2Exhaust Port - if not connected to a Gas Scavenging System) to accumulate, the result could beinaccurate Zeroing of the EtCO2 module and resulting inaccurate patient readings.CO2 OCCLUSION The air lines have become blocked. Check exposed hosefor kinks and blockages. If blockage appears to be internalto the unit, contact a Qualified Service Representative.
4-204.5 Anesthetic Agent/Oxygen Monitoring. (Optional) The Anesthesia Gas Sensor (AGS) is anon-dispersive, single path Infra-Red spectrometer based upon a high stability IR sensor technologyknown as Stabilized Thermopile Bridge (STB). Utilizing the STB technology, the Invivo AGS yieldshigh output, low noise and ultra stable gas measurements.The following two secondary menus support the Anesthetic Agent/Oxygen monitoringfeature:•RECORDER Menu. Used to select recorder functions and to set the recorder andtrace speed.•ALARMS Menu. Used to set and/or disable the temperature alarms.4.5.1 Patient and Tubing Preparation. Use only original Invivo sampling lines and accessories;other sampling lines may cause inaccurate readings and malfunctions. Change sampling line andairway adapter for each patient. Figure 4-17. Anesthetic Agents DisplayETCO2: HW FAIL The EtCO2 has failed, contact a Qualified ServiceRepresentative.ETCO2 WARMING UP The EtCO2 is warming up in preparation for use. Thewarmup cycle is approximately two (2) minutes.NO CO2 CAL: STILL WARMINGCO2 Calibration cannot initialize because the EtCO2system has not completed warming up. (For non-AgentEtCO2 only)READJUSTING CO2 ZEROThe EtCO2 module is performing its automatic ZeroAdjustment Routine.WARNINGAlways test sampling line adapter for a tight connection and proper operation before attaching to apatient.Overtightening the sampling line may damage the water trap. Tighten the sampling line no morethan 1/4 turn.
4-214.5.2 Associated Displays. (See Figure 4-17) Anesthetic Agent information is only displayed asnumeric data. Agent data can be displayed in Boxes 7 through 10. The Agent identification andmeasurement are individually performed on both inspired and expired gases. With any two mixturesinvolving gases Sevoflurane and Isoflurane, the inspired primary anesthetic agent (the gas with thehighest concentration) is displayed with its ID and concentration in the Fi location of the Agent Iconbox. The expired primary anesthetic agent is displayed with its ID and concentration in the Et locationof the Agent Icon box. An alarm sounds and “MULTIPLE AGENTS” is displayed any time two ormore anesthetic agents are detected. If Halothane or Enflurane are involved in any mixture ofanesthetic agents, “---” may appear in the Fi and/or Et location while a pure inspired or expired gas isdisplayed in its appropriate location. See Tables 4-1 and 4-2 for a complete description of the Agentdisplay during mixed Agent conditions.The following is a description of the items contained within the Anesthetic Agent Display.a. Icon Label. (Item 1) This label identifies the parameter numerics that are displayedwithin this box.b. Agent Expired Numeric. (Item 2) A numeric indication of the value of the gas beingexpired.c. Agent Inspired Numeric. (Item 3) A numeric indication of the value of the gas beinginspired.d. Et. (Item 4) Indicates that the top row numeric is the End Tidal (expired) values of thegas being monitored (with the designation of the gas located just below Et).e. Fi. (Item 5) Indicates that the bottom row numeric is the fraction of inspired (Fi) valuesof the gas being monitored (with the designation of the gas located just below Fi).f. Unit of Measurement. (Item 6) Displays the Unit of Measurement being used forpresentation of the Anesthetic Agents and Oxygen numeric data (i.e. Percentage).g. Oxygen Numeric. (Item 7) A numeric indication of the patient’s Oxygenmeasurement.h. O2. (Item 8) Indicates that the patient’s oxygen is being monitored in this row.
4-22Table 4-1. Agent Display During Mixed Agent ConditionsDisplay MULTIPLE AGENTS MessagePhysical GasSevoflurane, Isoflurane or any mixture of two where the gas with the highest concentration is considered primary.Agent DisplayInspired(Fi)Expired(Et)Fi ID% Inspired ConcentrationEt ID%Expired ConcentrationNo Agent 1 Agent 1 Agent 1 Agent 1Yes Agent 1 Agent 2 Agent 1 Agent 2Yes Agent 2 Agent 1 Agent 2 Agent 1Yes Agent 1 - PrimaryAgent 2 - SecondaryAgent 1 - PrimaryAgent 2 - SecondaryAgent 1 Agent 1Yes Agent 2 - PrimaryAgent 1 - SecondaryAgent 1 - PrimaryAgent 2 - SecondaryAgent 2 Agent 1Yes Agent 2 - PrimaryAgent 1 - SecondaryAgent 2 - PrimaryAgent 1 - SecondaryAgent 2 Agent 2Yes Agent 1 - PrimaryAgent 2 - SecondaryAgent 1 Agent 1 Agent 1Yes Agent 2 - PrimaryAgent 1 - SecondaryAgent 1 Agent 2 Agent 1Yes Agent 1 - PrimaryAgent 2 - SecondaryAgent 2 Agent 1 Agent 2Yes Agent 2 - PrimaryAgent 1 - SecondaryAgent 2 Agent 2 Agent 2Yes Agent 1 Agent 1 - PrimaryAgent 2 - SecondaryAgent 1 Agent 1No - - --- ---Yes Agent 1 Agent 2 - PrimaryAgent 1 - SecondaryAgent 1‘ Agent 2Yes Agent 2 Agent 2 - PrimaryAgent 1 - SecondaryAgent 2 Agent 2Yes Agent 2 Agent 1 - PrimaryAgent 2 - SecondaryAgent 2 Agent 1No Agent 1 - Agent 1 ---No - Agent 1 --- Agent 1No Agent 2 - Agent 2 ---No - Agent 2 --- Agent 2
4-23Table 4-2. Agent Display During Mixed Agent Conditionsi. Anesthetic Agent Designation. (Items 4 and 5) Displays the identification of the gasbeing monitored. The Agent Identifications are as follows:(1) Halothane HAL(2) Isoflurane ISO(3) Sevoflurane SEV4.5.3 Agent Menu. The Anesthetic Agent monitoring feature does not have a menu like the othermonitoring features on this monitor. Pressing the Rotary Knob while the AGENTS icon is highlightedbrings up a box which displays the Minimum Alveolar Concentration (MAC) values. 1 MAC Valuesused to Calculate the displayed MAC are as follows: HAL=0.76%, ENF=1.68%, ISO=1.12%,SEV=1.92%, DES=6.0% and N2O=100%.Calculation of displayed MAC value: Cal. MAC = (EtN2O/1 MAC N2O) + (Et Agent/1 MAC Agent).4.5.4 Gas Calibration. The monitor performs a Zero Calibration periodically and the operator mayalso manually initiate a Zero Calibration cycle. There is a two (2) minute warmup period when Agentsis first turned on during which there is no monitoring. The entire warmup period is 20 minutes duringwhich the monitor will perform an automatic Zero Calibration at the two minute mark in the warmupperiod, then will run again in the following sequence: 4, 6, 8, 10, 12, 14, 16, 18, 20, 40 and 60 minutes.After the 60 minutes has expired the Zero Calibration will run once an hour, or whenever an anestheticagent change is detected. Display MULTIPLE AGENTS MessagePhysical GasHalothane and involved mixes. Agent DisplayInspired(Fi)Expired(Et)Fi ID% Inspired ConcentrationEt ID%Expired ConcentrationNo Agent 1 Agent 1 Agent 1 Agent 1Yes Agent 1 Agent 2 Agent 1 ---Yes Agent 1 Mix Agent 1 ---Yes Mix Agent 2 --- Agent 2Yes Mix Mix --- ---No Agent 1 - Agent 1 ---Yes Mix - --- ---No - Agent 2 --- Agent 2Yes - Mix --- ---No - - --- ---WARNINGMinimum Alveolar Concentration (MAC) values are empirical and are not absolute values. Invivo'sAGS MAC values correspond to those of healthy adults and cannot be applied to children. Age andother individual factors influencing the behavior of volatile agents are not taken into account.NOTEMixed concentration of Agents are not included in the MAC calculations.
4-24On the WPU only, if the Agents option is run over a continuous 12 hour period with an O2concentration of 22% or greater there is a Warning Box that will appear to alert the operator that aone (1) minute O2 Calibration sequence must be run. The Warning Box will offer the operator aYes/No option of running the one (1) minute O2 Calibration sequence, if the operator selects NO,the message will reappear in 30 minutes. An O2 Calibration message will also appear if the O2Sensor detects a reading greater than 103% and whenever an O2 sensor is inserted into the back ofthe monitor (if the monitor has completed its CO2 zeroing process).a. Anesthetic Agent Quality Control (QC) Check. Perform a QC Check at least once amonth, or whenever Agent accuracy is questionable.(1) Before performing the Anesthetic Agent QC Check, the monitor must be at astable operating temperature. The monitor must be turned on, with EtCO2 andAgent parameters active, for a minimum of 45 minutes before the QC check isperformed.(2) Each QC Check Gas can comes with a nozzle and tubing with a “T” fitting forconnecting to the gas (EtCO2) input port in the monitors front panel.(3) See the Accessories List in the Table of Contents Section of this manual forselection of the QC Check Gas for the Anesthetic Agents you are using.(4) If required, Agent Span Calibration can be performed. Refer to serviceinstructions for this procedure.4.5.5 Alarm Limits. The Agent Alarm Limits are set by selecting the GAS ALARMS menu optionin the ALARMS Menu, which is accessed by pressing the ALARMS SCREEN Menu-Select Key, orby highlighting the AGENT Icon and pressing the ALARMS SCREEN Menu-Select Key to accessthe ALARMS Menu.4.5.6 Trended Data. For complete information on the trending of patient Agent data, see Section 5:Printing and Trending.4.5.7 Agent/O2 Messages. The following messages are used for Anesthetic Agent/O2 monitoring:NOTEPatient Waste Gas Removal. Continuous exposure of Health Care workers to waste anestheticgases (including halogenated agents and nitrous oxide) is not recommended. Always attach thewaste gas connection on the rear of the monitor to the room's gas evacuation system. Avoid ventingany waste anesthetic gas directly into the room air as exposure to waste anesthetic gases above therecommended OHSA limits could result.Flashing Insp CO2 Numeric (Fixed CO2 Rebreathing Alarm) The Inspired CO2numeric turns red and flashes with Alarm sound. Occurswhen Inspired CO2 is greater than 25 mmHg. Thisalarm is a fixed, non-adjustable alarm.Flashing N2O Numeric (Fixed N2O Alarm) N2O numeric turns red and flasheswith Alarm sound. Occurs when N2O is greater than80%. This alarm is a fixed, non-adjustable alarm.EtCO2 WARMING UP Message flashing red. Occurs during CO2/AnesthesiaGas Sensor warmup.CO2 OCCLUSION Message flashing red with Alarm sound. Occurs whensample line is occluded.MULTIPLE AGENTS Message flashes red with Alarm sound. Occurs whenmore than one Anesthetic Agent is identified.
4-254.5.8 Oxygen Monitoring. This parameter is part of the EtCO2/Agents module. That is, it uses theexhaust air from the EtCO2/Agents module as its imput and its air flow is controlled by the pneumatichardware in the EtCO2/Agents hardware module. The O2 value is displayed in the Anesthetic AgentsDisplay (See Figure 4-17).a. Oxygen Module Calibration. The O2 module is calibrated automatically uponpower-up (as described in the NOTE above). Thereafter, is calibrated everytime an O2CAL is initiated by the user (See the GAS CAL menu (SETUPS/SERVICE(BIO-MED)/GAS CAL) for further information). The operator is prompted that an O2calibration is required if O2 remains above 22% for 12 hours and, since O2 calibrationrequires one (1) minute, the operator may reject the calibration request by answeringNO to the YES/NO prompt. If NO is selected the operator is then prompted every 30minutes until the O2 calibration is initiated by a YES response. Calibration is donebased on the assumption that the ambient O2 concentration, sensed at the EtCO2Zeroing Port, is 20.9% (during calibration, the patient GAS Input Port must not beconnected to an oxygen source).b. Oxygen Sensor Replacement. The Oxygen Sensor (Invivo Part Number 9445) islocated on the rear of the WPU near the DCU mounting pole. The Oxygen Sensor hasan expected life of greater than six months with expected life inversely proportional tochanges in Oxygen Concentration, Temperature and Pressure. The Oxygen Sensorbegins aging immediately upon the opening of the package and should, therefore, notbe opened until ready for use. The Oxygen Sensor should be replaced periodically aspart of routine maintenance. This monitor cannot be connected to the scavenge gassystem without the Oxygen Sensor installed, never operate without the monitorconnected to the scavenge gas system. Always operate the monitor with the OxygenSensor installed.(1) Oxygen Sensor Replacement Instructions. Replace the Oxygen Sensor asfollows:(a) Unplug the adapter cable from the Oxygen Sensor.(b) Unscrew the Oxygen Sensor by turning it counterclockwise until itcomes free.(c) Open bag containing new disposable Oxygen Sensor (IRI #9445).(d) Screw Oxygen Sensor into threaded port on Adaptor Subassembly.(e) Plug adapter cable assembly into the Oxygen Sensor.READJUSTING CO2 ZEROMessage flashing red. Occurs during CO2/AnesthesiaGas Sensor zeroing operation.REPLACE O2 SENSOR The Oxygen Sensor is bad and must be replaced.NOTEWhen the Agents parameter is turned on the O2 sensor is automatically calibrated during initialwarm up of the EtCO2/Agent Module. During this time the patient GAS input port must not beconnected to an oxygen source as the monitor requires 20.9% Oxygen (room air) for automaticcalibration.
5-1SECTION 5RECORDING AND TRENDING5.0 RECORDING AND TRENDING.5.1 Introduction. The 3160 MRI Physiological Monitoring System thermal array striprecorder can record one or two waveforms (as selected from the RECORDER Menu). The recorderprints patient parameters on the edge of the strip chart and ends with a “snapshot” patient data report.The Recorder option provides the following features:• Selection of the traces to be sent to the recorder.• High frequency response (Single = 800 samples/second at 25 mm/second speedand Dual = 400 samples/second at 25 mm/second speed) with a bandwidth of 100Hz.• Transmitting a calibration waveform to the recorder.• Total control over the Recorder mode (OFF/AUTO/RUN).• Selection of patient data report for printing.• Selection of data collection intervals for report.• 0 to 16 seconds of trace delay in four increments.• Selection of 25 or 50 mm/second recorder speed (and screen trace speed).• The paper record is automatically annotated with the alphanumeric indication ofdate, time, trace delay, paper speed, scales, lead configuration, mode, heart rate,NIBP (which displays systolic, diastolic and mean blood pressures), respirationrate, EtCO2, SpO2 and Agent Gas ID for expired and inspired breath phases.• If an active alarm limit is violated, the numeric value of the correspondingparameter is printed at the beginning of the automatically activated record.• The recorder uses non-grid thermal paper.5.1.1 Record Key. The RECORD key starts/stops the Recorder upon operator demand. If leftrunning the recorder will continue to supply hard copy output for approximately 25 seconds before itautomatically shuts off.5.2 The RECORDER Menu. The RECORDER Menu provides adjustments that will allowthis monitor to supply concise and up to date printouts suitable to a wide variety of situations. Pressingthe RECORDER SETUP Menu-Select key brings up the RECORDER Menu (See Figure 5-1). Ifthe recorder is not installed, the message “RECORDER OPTION NOT INSTALLED” is displayedon the screen. This menu has a time-out feature. If no action is taken for approximately 60 seconds,the monitor will automatically return to the Normal Screen.The following is a description of the options in the RECORDER Menu:a. TRACE 1. Selecting this menu option allows the selection of the first trace to beoutput to the recorder. The options [depending on currently installed parameters] areECG1 (default), SPO2 and RESP(CO2). If TRACE 2 is off, TRACE 1 is output to therecorder using the full 40 mm width of the printout.b. TRACE 2. Selecting this menu option allows the selection of the second trace to beoutput to the recorder. The options [depending on the currently installed parameters]are OFF (default), ECG1, SPO2 and RESP(CO2).NOTEThe Recorder unit is only available on the DCU.
5-2 Figure 5-1. The RECORDER Menuc. TRACE DELAY. Selecting this menu option allows the selection of the time delay forthe trace data being sent to the recorder. The options are 0, 4 (default), 8 and 16seconds.d. PRINT DATA REPORT. Selecting this menu option activates the recorder to print apatient data report (in tabular form) of up to 60 stored patient parameter readings storedin the time interval preselected by the DATA INTERVAL menu option in this menu.Only those parameters which have been turned on will be printed.(1) The Data Report printout consists of the updates (updated every four minutes)of the patient parameters (that are on during the data storage time) up to 60measurements. The current date and the time of the recording are clearlymarked on the left of the printout.(2) If a parameter is off during any portion of the data storage period, the message`---/---' shall be printed in place of its value.(3) The Data Report printout ends with a lined area for writing in the ID/CASEnumber, the Patient's Name and the Operator Comments.e. PRINT NIBP REPORT. Selecting this menu option activates the recorder to print theNIBP report, with the last 48 NIBP readings in tabular form (6 readings per page).f. CLEAR ALL. Pressing this function key erases all data stored for and the data reportin the monitor. When first pressed, a YES/NO Menu selection box appears thatrequires an affirmative operator response before the stored data is cleared. Theoperation of this function key requires confirmation by the user.g. DATA INTERVAL. Selecting this menu option selects the data interval (1 - 60minutes) for stored patient parameter readings to be printed in the Data Report(activated by pressing the PRINT DATA REPORT menu option in this menu). Theoptions (in minutes) are 1 through 10 (3 being the default), 12, 15, 18, 24, 30 and 60.The first data stored occurs either at power up, or 2 seconds after a new interval isselected.h. OFF/AUTO/RUN. Selecting this menu option allows the switching of the mode of theRecorder. The options are OFF, AUTO and RUN. The following is an explanation ofthe possible selections:(1) OFF. Switches the Recorder Auto Mode OFF (the recorder may be activatedby pressing the RECORD Control Key.
5-3(2) AUTO. If AUTO is selected, violation of an alarm limit for HR, NIBP, EtCO2and SpO2 automatically activates the recorder trace and writes ECG Trace A.In addition to ECG Trace A, a second trace will be written below it when theparameter is in a trace location. The priority of the second trace recording isRESP(CO2). SpO2 is written as the second trace recording when its alarmlimit is in violation and is the only other parameter in a trace location.(a) The recording continues for 20 seconds or until the recorder isdeactivated by pressing the RECORD key or by changing theRecorder Auto Mode to Off.(3) RUN. RUN activates the recorder and prints the traces which have beenselected.i. AUTO STRIP. Selecting this menu option allows the Automatic Report feature of theRecorder to be switched On and Off. The options are DISABLED, ENABLED andRETURN. The following is a description of the possible selections:(1) DISABLED. Selecting this menu option will turn the Automatic ReportFeature OFF.(2) ENABLED. Selecting this menu option will turn the Automatic ReportFeature ON.(3) RETURN. Selecting the menu option will return the monitor to theRECORDER Menu.j. AUTO RUN TIME. Selecting this menu option brings up the AUTO RUN TIMEMenu where the operator can select the Automatic Strip Run Time. The options are 8,12, 16, 20 and 30 seconds.k. SWEEP SPEED. This menu option switches the recorder and the screen trace speedbetween 25 and 50 mm/second.l. CALIBRATE. Selecting this menu option opens the CALIBRATE Menu. This menuoption is identical to and interactive with the calibrate option in the ECG Menu. Thefollowing options are available in the CALIBRATE Menu:(1) OFF. Selecting this menu option turns the Calibration feature OFF.(2) RECORDER. Selecting this menu option sends a 1mV pulse calibrationwaveform to the ECG Vital Sign and will also be the ECG waveform printedby the recorder if so configured. The message CAL is displayed over the ECGwaveform on the screen.(3) ECG. Selecting this menu option sends a 2mV peak to peak (1mV peak)calibration signal to the ECG vital sign and will also be the ECG waveformprinted by the recorder if so configured. The message CAL is displayed overthe ECG waveform on the screen. It is important to note that this is a hardwaregenerated calibration waveform and originates as a square wave.(4) RETURN. Selecting this menu option closes the CALIBRATE Menu.m. RETURN. Selecting this menu option will return the monitor to the Normal Screen.5.3 Recording Charts. This monitor will print four different types of charts upon operatordemand. The four types are Strip Chart, Tabular Chart, Trend Chart and System Data Report. TheSweep Speed of the printout may be set to 25 mm/second or 50 mm/second with the slower speed (25mm/second) presenting the most data on a Strip Chart. Strip Charts, Tabular Charts and System DataReports are discussed below (Trend Charts are discussed in paragraph 5.5):
5-4 Figure 5-2. Sample Strip Chart5.3.1 Strip Chart Record. (See Figure 5-2) The Strip Chart may be configured to contain one ortwo parameter waveforms and also contains the numerical value of every active parameter as well as a“Parameter Snapshot” of the current values of every active parameter at the end of the printout strip.a. Setting Up the Strip Chart. Perform the following procedure to configure the StripChart to the appropriate application:(1) Press the RECORDER SETUP Menu-Select Key.(2) To change Trace 1, which is defaulted to ECG1: press the Rotary Knob,highlight the desired parameter and press the Rotary Knob to accept the newselection.(3) To change Trace 2, which is defaulted to OFF: highlight Trace 2 then press theRotary Knob, highlight the desired parameter and press the Rotary Knob toaccept the new selection.(4) To set the Trace Delay, which is defaulted to 4 seconds: highlight Trace Delaythen press the Rotary Knob, highlight the desired delay (the options are 0, 4, 8and 16 seconds) and press the Rotary Knob to accept the new selection.(5) To set the monitor to provide a Strip Chart automatically, perform thefollowing:(a) Select the desired time between automatic strips by highlighting theData Interval menu selection, pressing the Rotary Knob, highlightingthe desired time interval and pressing the Rotary Knob to accept theselection.(b) Set the Auto Strip to On by highlighting the Auto Strip menu selection,pressing the Rotary Knob, highlighting Enabled and pressing theRotary Knob to accept the selection.(6) To manually print a Strip Chart, press the RECORD control key. Figure 5-3. Sample Tabular Chart5.3.2 Tabular Chart Record. (See Figure 5-3) The NIBP/SpO2 Tabular Report provides ahardcopy printout of the numerical indications of NIBP, Heart Rate, SpO2, CO2 and Respiration alongwith the date and time of the determination.
5-55.3.3 Trend Chart. Trend Charts may be printed for every parameter being monitored. To print anindividual trend chart, first highlight the icon of the parameter to be printed then press the TrendsMenu-Select key and select the RECORD menu option. Figure 5-4. System Data Report5.3.4 System Data Report. (See Figure 5-4) The System Data Report provides a hardcopy printoutof the numerical indications of all the active patient parameters along with the date and time of thedetermination.5.4 Loading Recorder Paper. Perform the procedure in Figure 5-5 to load the recorder paper. Figure 5-5. Loading the Recorder Paper5.5 Trending Feature. The Trend Feature may be operated to graph Multiple or IndividualTrends. Pressing the TRENDS Menu-Select Key, while in the Normal Screen, will bring up theHISTORY Menu (See Figure 5-6). Pressing it while any Patient Parameter is highlighted will bringup the Trend Menu for the Selected Patient Parameter. The 3160 Vital Signs Monitoring Systemautomatically stores the parameter trend information for the heart rate, NIBP, SpO2, EtCO2 andRespiration. There is also an operational key, CLEAR TRENDS, on the monitor front panel thatallows the operator to clear all trends without bringing up any of the TREND Menus.
5-6 Figure 5-6. The HISTORY Menu5.5.1 HISTORY Menu Options. The HISTORY Screen is a Tabular Listing of a patient's NIBPdeterminations. The menu provides the option to move from page to page and to print all or part of theHistory File. The following is a description of the options available in the HISTORY Menu:a. PRT ALL. Selecting this menu item will print a complete NIBP History File.b. PRT PAGE. Selecting this menu item will print the NIBP History File page that thescreen is currently at.c. PREV PAGE. Selecting this menu item will change the display to the previous pageof the NIBP History File.d. NEXT PAGE. Selecting this menu item will change the display to the next page of theNIBP History File.e. CLEAR ALL. Selecting this menu item will clear all the data from the NIBP HistoryFile.f. RETURN. Selecting this menu item will return the monitor to the Normal Screen.
6-1SECTION 6ALARMS6.0 ALARMS.6.1 Introduction. The 3160 MRI Physiological Monitoring System permits user access toevery parameter alarm with a single select key. Alarm Limits may be turned on, adjusted (manually orautomatically) or turned off in the ALARMS Menu. Individual parameter alarms may also be turnedon and/or adjusted by highlighting the parameter icon and pressing the ALARMS SCREEN Menu-Select key.• The 3160 MRI Physiological Monitoring System may be set to give visual alarmsignals only (Alarm Limits set, but Alarm Sound off), or both visual and audiblesignals (Alarm Limits set, with Alarm Sound on).• All settings in the ALARMS Menu, except the Alarm Sound On/Off and SoundMode, can be stored and recalled.6.2 Alarm Limits. The Alarm Limits may be set either manually or automatically. The 3160MRI Physiological Monitoring System provides access to parameter Alarm Limits through a menuaccessed with the ALARMS SCREEN Menu-Select Key. Alarm Limits may be turned on, adjusted(manually or automatically) or turned off in the ALARMS Menu.6.2.1 Default (Pre-Set) Alarm Limits. This monitor will automatically set all the Alarm Limits toDefault settings upon monitor power up. Table 6-1 provides a listing of Factory Default Settings; it isimportant to note that Table 6-1 will not represent the Default Values of your monitor if the DefaultValues are selected by the User.6.2.2 Range of High and Low Alarm Limits. Each patient parameter has a LOW and HIGHAlarm Limit value position as indicated by numerics in the LOW and HIGH columns of Table 6-2.The Alarm Limits displayed in this menu may be changed manually or automatically using the rotaryknob, after the patient parameter is selected. If a parameter has been turned off from the SETUPSMenu, then its LOW and HIGH positions will be off on this menu.6.3 Alarm Setup. Pressing the ALARMS SCREEN Menu-Select Key while in the normalmonitoring mode (Normal Screen displayed) with no icons highlighted will bring up the ALARMSMenu (See Figure 6-1). Figure 6-1. The ALARMS MenuNOTEThe Alarm System automatically prevents the crossover of High and Low Limit settings.
6-2This menu has the following menu options associated with it:a. SET INDIVIDUAL. Selecting this menu option allows the operator to adjustindividual Alarm Limits. Once this menu option is selected, turning the knob willallow the operator to scroll through the individual HIGH and LOW Alarm Limits formanual modification. Once the limit to be modified is highlighted, pressing the knobselects the limit and turning the knob changes the value. When the desired setting isshown in the window, pressing the knob again will make the change effective andreturn to scrolling through the individual HIGH and LOW Alarm Limits.b. CALCULATE ALL. Selecting this menu option causes the monitor to calculate newalarm limit values on all active parameters at once. The calculations are as describedunder UPPER WINDOW and LOWER WINDOW menu options.c. UPPER WINDOW. Selecting this menu option selects the percent value used incalculating the HIGH Alarm Limits with the CALCULATE ALL menu option. Themenu options are 5%, 10%, 15%, 20% (default), or 30%. The monitor uses the currentvalue of the parameter and brackets it with the percentages set by this menu option andthe LOWER WINDOW menu option.(1) For example, if the patient's heart rate is 60, and both percentages have been setto 10%, activating CALCULATE ALL menu option will set the LOW AlarmLimit to 54 and the HIGH to 66 (plus and minus 10 percent of the current heartrate). Corresponding calculations would be used on each of the other activepatient parameters to set their LOW and HIGH values.(2) The following exception applies:• If the value being monitored from the patient is so high or low thatit would exceed the range of 3160 MRI Physiological MonitoringSystem Alarm Limits (see below), the LOW or HIGH value is set tothe highest or lowest Alarm Limit for that parameter.d. LOWER WINDOW. Selecting this menu option selects the percent value that is usedin calculating the LOW Alarm Limits with the CALCULATE ALL menu option. Themenu options are 5%, 10%, 15%, 20% (default), or 30%. The monitor uses the currentvalue of the parameter and brackets it with the percentages set by this menu option andthe UPPER WINDOW menu option.(1) For example, if the patient's heart rate is 60, and both percentage have been setto 10%, activating CALCULATE ALL would set the LOW Alarm Limit to 54and the HIGH to 66 (plus and minus 10 percent of the current heart rate).Corresponding calculations would be used on each of the other active patientparameters to set their LOW and HIGH values.The following exceptions apply:• If the value being monitored from the patient is so high or low thatit would exceed the range of 3160 MRI Physiological MonitoringSystem Alarm Limits (see below), the LOW or HIGH value is set tothe highest or lowest Alarm Limit for that parameter.e. ALARM SOUND. Selecting this menu option will turn the alarm sound on/off. Whenturned off, an “X” appears in the bell symbol on the screen and the bell symbol in themenu indicating that the alarm sound has been disabled. This menu option is identicalto, and interactive with, the ALARMS menu option in the SOUND ADJUST Menu.f. DEFAULT LIMITS. Selecting this menu option causes the monitor to automaticallyset the LOW and HIGH Alarm Limits for all parameters at once based on the systemdefaults (See Default Limits in Appendix A or Table 6-1 for a listing of the SystemDefault Values).
6-3g. TYPE. Selecting this menu option will select whether the audio and visual alarms arelatched or unlatched (see definitions below).(1) UNLATCHED. The Alarm Tone stops if the violated parameter returns towithin its limits, or the ALARM SILENCE key is pressed.(2) LATCHED. The Alarm Tone will cease only when the ALARM SILENCEkey is pressed, even if the violating parameter has returned to within its limits.h. LIMITS DISPLAY. Selecting this menu option will select whether or not the AlarmLimits are displayed next to the parameter value in the Normal Screen. The default isON. Figure 6-2. GAS ALARMS (Anesthetic Agents Alarm Limit) Menui. GAS ALARMS. Selecting this menu option will bring up the GAS ALARMS(Anesthetic Agent Alarm Limits) Menu (See Figure 6-2). All the Alarm Limitsassociated with the Anesthetic Agent System are adjusted in this menu. The followingis a description of the GAS ALARMS Menu:This menu has the following menu options associated with it:(1) SET INDIVIDUAL. Selecting this menu option allows the operator to adjustindividual Anesthetic Agent Alarm Limits. Once this menu option is selected,turning the knob will allow the operator to scroll through the individual AgentAlarm Limits for manual modification. Once the limit to be modified ishighlighted, pressing the knob selects the limit and turning the knob changesthe value. When the desired setting is shown in the window, pressing the knobagain will make the change effective and return to scrolling through theindividual Agent Alarm Limits.(2) CALCULATE AGENT/O2. Selecting this menu option causes the monitorto calculate new alarm limit values on all active Agent and O2 settings at once.The calculations are as described under UPPER WINDOW and LOWERWINDOW menu options.(3) UPPER WINDOW. Selecting this menu option selects the percent value usedin calculating the HIGH Alarm Limits with the CALCULATE AGENT/O2menu option. The menu options are 5%, 10%, 15%, 20% (default), or 30%.The monitor uses the current value of the parameter and brackets it with thepercentages set by this menu option and the LOWER WINDOW menu option.
6-4(4) LOWER WINDOW. Selecting this menu option selects the percent value thatis used in calculating the LOW Alarm Limits with the CALCULATEAGENT/O2 menu option. The menu options are 5%, 10%, 15%, 20%(default), or 30%. The monitor uses the current value of the parameter andbrackets it with the percentages set by this menu option and the UPPERWINDOW menu option.(5) ALARM SOUND. Selecting this menu option will turn the alarm sound on/off. When turned off, an “X” appears in the bell symbol on the screen and thebell symbol in the menu indicating that the alarm sound has been disabled. Thismenu option is identical to, and interactive with, the ALARMS menu option inthe SOUND ADJUST Menu.(6) DEFAULT LIMITS. Selecting this menu option causes the monitor toautomatically set the LOW and HIGH Alarm Limits for all parameters at oncebased on the system defaults (See Default Limits in Appendix A or Table 6-1for a listing of the System Default Values).(7) TYPE. Selecting this menu option provides the operator the option to selectwhether the audio and visual alarms are latched or unlatched (see definitionsbelow).(a) UNLATCHED. The Alarm Tone stops if the violated parameterreturns to within its limits, or the ALARM SILENCE key is pressed.(b) LATCHED. The Alarm Tone will cease only when the ALARMSILENCE key is pressed, even if the violating parameter has returnedto within its limits.(8) RETURN. Selecting this menu option will return the monitor to the NormalScreen.j. RETURN. Selecting this menu option will return the monitor to the Normal Screen.6.3.1 Parameter Alarms Status Screen. While in the Alarms Screen, the Parameter Alarms StatusScreen is displayed to the right of the ALARMS Menu. This screen provides the operator with theLow and High Alarm Limit Setting along with the Current Measurement value. By using the SETINDIVIDUAL menu option with the Rotary Knob, the operator may adjust all the available parameterlimit settings.6.4 Turning Alarms Off on Individual Parameters. Alarms may be set to OFF by pressingthe ALARMS SCREEN menu select key, selecting the SET INDIVIDUAL menu option and thenscrolling to the desired parameter to select it and turn it OFF.6.5 Alarm Violations. An active Alarm Limit is violated when a patient parameter eitherexceeds its HIGH setting or goes below its LOW setting. The alarm system's exact reaction depends onthe settings described in the remainder of this section, but, in general, all alarms operate as follows:a. The numerics and trace (if displayed) of the violated parameter flash red on the screen.b. The Alarm Tone on the DCU sounds, if it is enabled.c. The numerics continue to flash while the parameter violates its Alarm Limit, even afterthe Alarm Tone has been silenced by pressing the ALARM SILENCE key.d. If the Printer is in the AUTO mode, it begins recording. For further information, seeSection 5.WARNINGAlarm Limits can be set to a wide range including Off. It is the responsibility of the operator of thismonitor to ensure that Alarm Limit values appropriate to each particular patient are established andset.
6-5e. The numerics stop flashing after the parameter returns to within its Alarm Limits. If thealarm system has been set to LATCHED, the numeric continues to flash after theparameter returns to within its Alarm Limits, until the ALARM SILENCE controlkey is pressed.f. The numerics of the violated parameter flash on the screen and the audible alarm, oncesilenced, will not sound again until after the alarm condition has been corrected. Only asecond (different) parameter alarm will cause the alarm sound to reactivate.6.6 Adjusting the Alarm Tone Volume The Alarm Tone is adjusted in the SOUND ADJUSTMenu, which is accessed by selecting the SOUND ADJUST menu option in the SETUPS Menu.6.6.1 Disabling the Alarm Tone The Alarm Tone may be disabled permanently in the ALARMSMenu or it may be disabled temporarily by pressing the ALARM SILENCE control key.a. The ALARM SILENCE control key has four functions as follows:(1) WITH UNLATCHED ALARMS. If the alarm system has been set toUNLATCHED in the ALARMS menu and an Alarm Limit is violated:• It silences the alarm tone when an active Alarm Limit has beenviolated.WHILE THE PARAMETER CONTINUES TO VIOLATE ITS LIMITS:• The numeric of the violated parameter will continue to flash on thescreen.(2) WITH LATCHED ALARMS. If the alarm system has been set toLATCHED in the ALARMS menu and an alarm is violated:WHILE THE PARAMETER CONTINUES TO VIOLATE ITS LIMITS:• It will silence the Alarm Tone.• The numeric will continue to flash, even after the parameter returnsto within its Alarm Limits.WHEN THE PARAMETER GOES BACK WITHIN LIMITS:• It will silence the Alarm Tone, stops the numeric from flashing andputs the Alarm System into the Alarm Hold mode.WHEN THE ALARM HAS BEEN SILENCED AND THE PARAMETERRETURNS TO WITHIN LIMITS:• Pressing ALARM SILENCE will stop the numeric from flashingand puts the Alarm System into the Alarm Hold mode.NOTEThe Alarm Tone only applies to the DCU, there is no speaker on the WPU.WARNINGOnce an alarm condition has been silenced it will not sound again for any reason as long as thatalarm condition continues. For example, if a patients Heart Rate drops below the set limit and thatalarm is silenced, the alarm will never sound that condition again unless the Heart Rate returns towithin limits and then drops below the limit again.
6-6(3) ALARM SILENCE. When the monitor goes into Alarm, pressing theALARM SILENCE control key silences the Alarm Tone for the current alarmonly. While the monitor is in the Silence mode, the letter “S” is displayedwithin the Alarm Status Symbol (Alarm “Bell”), the Alarm Bell flashes and thetext “Alarm Silenced” is displayed in the middle of the display screen. If any ofthe silenced alarm conditions return to acceptable limits, the monitor willrespond according to the above described Latched and or Unlatched operation.If a new alarm occurs after the Silence mode is entered, the monitor will soundthe Alarm Tone for the new alarm. Pressing the ALARM SILENCE controlkey a second time (after entering the Silence mode) will place the monitor intothe Alarm Hold state.(4) Alarm Hold “SOUND ON HOLD” Mode. The Alarm Tone must be turnedon (no “X” in the bell shaped Alarm Status Symbol) to enter SOUND ONHOLD. The Sound on Hold feature is used to temporarily disable the AlarmTone. This might be useful, for example, when changing ECG leads, whendrawing blood from an arterial pressure line or for any user activity whichmight cause an unwarranted alarm.WHEN NO ALARM CONDITION EXISTS:• Pressing the ALARM SILENCE key will activate Sound on Hold(a “SOUND ON HOLD” message appears in the middle of thescreen and an “H” appears in the Alarm Status Symbol). Just underthe message there is a count down timer starting at 180 (countingdown at a 1 second rate) giving the time left before the Alarm Toneis reactivated.WHEN AN ALARM CONDITION EXISTS:• If the Alarm Tone is sounding, the first press of the ALARMSILENCE key stops the Alarm Tone, and a second press enablesSound on Hold.AUTOMATIC EXIT FROM ALARM HOLD:• The monitor will automatically exit alarm hold after 180 seconds,and the “SOUND ON HOLD” message will disappear from thescreen.MANUAL EXIT FROM ALARM HOLD:• To exit from Sound on Hold before 180 seconds, press theALARM SILENCE key (which will remove the “SOUND ONHOLD” message from the screen).6.7 Standby Mode. Pressing the STANDBY Control Key will place the monitor into theStandby Mode. While in the Standby Mode the monitor will continue to track and update the activepatient parameters but three key features will be disabled: 1) All audible alarms are disabled; the factthat the alarms are disabled is indicated on the Display Screen by an X through the bell shaped AlarmsStatus Symbol; it is also important to note that the Parameter Waveform and/or Numeric Displaycontinue to operate normally and will turn Red if any active parameter violates its Alarm Limits, 2)automatic NIBP Measurements are suspended (if active, the current measurement will abort), and 3)No Automatic Printout is generated. When NIBP measurements are resumed, the intital reading will betaken at the default inflation pressure that is used for all initial NIBP measurements.
6-7Table 6-1. Alarm Limit Factory Default SettingsAdult Values Neonatal ValuesParameter Low Limit High Limit Low Limit High LimitHeart Rate 45 bpm/6.0 kPa160 bpm/21.3 kPa90 bpm/12.0 kPa210 bpm/28.0 kPaNIBP Systolic 65 mmHg/8.7 kPa190 mmHg/25.3 kPa70 mmHg/9.3 kPa100 mmHg/13.3 kPaMean 55 mmHg/7.3 kPa135 mmHg/18.0 kPa40 mmHg/5.3 kPa90 mmHg/12.0 kPaDiastolic 40 mmHg/5.3 kPa125 mmHg/16.7 kPa35 mmHg/4.7 kPa50 mmHg/6.7 kPaSpO2 85% Off 90% 98%EtCO2 15 mmHg/2.0 kPa60 mmHg/8.0 kPa30 mmHg/4.0 kPa45 mmHg/6.0 kPaRespiration 4 rpm 40 rpm 30 rpm 70 rpmET Halothane Off 1.5 N/A N/AFi Halothane Off 2.2 N/A N/AET Isoflurane Off 2.3 N/A N/AFi Isoflurane Off 3.4 N/A N/AET Sevoflurane Off 4.1 N/A N/AFi Sevoflurane Off 6.1 N/A N/AFiO2 15 99 N/A N/ACO2 Inspired (Fixed non-adjustable) N/A 25 mmHg/3.3 kPaN/A 25 mmHg/3.3 kPaN20 (Fixed non-adjustable) N/A 80% N/A 80%
6-8Table 6-2. Range of Alarm LimitsInput Adult Neonate UnitLow High Low HighHeart Rate Off, 30 to 249 60 to 249, Off Off, 30 to 249 60 to 249, Off bpmNIBP Off, 5 to 249Off, 0.7 to 33.25 to 249, Off0.7 to 33.2, OffOff, 5 to 249Off, 0.7 to 33.25 to 249, Off0.7 to 33.2, OffmmHgkPaSpO2 Off, 50 to 99 70 to 99, Off Off, 50 to 99 70 to 99, Off %Respiration Off, 4 to 40 20 to 150, Off Off, 4 to 40 20 to 150, Off rpmEtCO2 Off, 5 to 60Off, 0.7 to 8.05 to 80, Off0.7 to 10.7, OffOff, 5 to 60Off, 0.7 to 8.05 to 80, Off0.7 to 10.7, OffmmHgkPaET Halothane Off, 0.1 to 5.9 0.1 to 6.0, Off Off, 0.1 to 5.9 0.1 to 6.0, Off %Fi Halothane Off, 0.1 to 5.9 0.1 to 6.0, Off Off, 0.1 to 5.9 0.1 to 6.0, Off %ET Isoflurane Off, 0.1 to 5.9 0.1 to 6.0, Off Off, 0.1 to 5.9 0.1 to 6.0, Off %Fi Isoflurane Off, 0.1 to 5.9 0.1 to 6.0, Off Off, 0.1 to 5.9 0.1 to 6.0, Off %ET Sevoflurane Off, 0.1 to 8.9 0.1 to 9.0, Off Off, 0.1 to 8.9 0.1 to 9.0, Off %Fi Sevoflurane Off, 0.1 to 8.9 0.1 to 9.0, Off Off, 0.1 to 8.9 0.1 to 9.0, Off %O2 15 to 99 15 to 99 15 to 99 15 to 99 %
7-1SECTION 7BATTERY OPERATION7.0 BATTERY OPERATION.7.1 Introduction. The system components are equipped with Lithium Ion Batteries whichprovide battery power for at least eight (8) hours.7.2 Battery Location and Access. The WPU has two batteries that are located on the front ofthe unit; the DCU also has two batteries and they are located on each side of the unit; the WSPO2 andWECG telemetry transmitters both have a single battery which is located on the back of the units.7.3 Loading and Unloading Battery(s). The WPU and DCU battery packs slide into a slot andsnap into place; to remove press the button associated with the battery pack to be removed and thebattery pack will pop out enough to be grasped and removed. On the WECG and WSPO2 telemetrytransmitters the battery pack slides along a groove and snaps into place; to remove press the clips oneach side and slide the battery pack from the unit.7.4 Battery Charging. The WPU and DCU use the same modular design Battery Packs; batterycharge time is less than 12 hours with an intelligent Battery Capacity Indication in the Battery PackScale displaying 20% to 100% in 20% increments. 7.5 Battery Operation Time. The WPU, DCU and telemetry transmitters will operate at leasteight (8) hours with fully charged batteries. Battery operation time may be affected by certainoperations (i.e.: Anesthetic Agents option turned on, printing of charts and trends and shortAutomatic NIBP Cycle times).7.5.1 Battery Low Indication. When a Battery Low condition exists there is no communicationbetween the different components of the system.7.6 Battery Replacement. If during operation, the monitor will not operate on battery power forthe approximate times given above, replacement of the batteries is recommended.CAUTIONAll batteries must be removed prior to shipping the monitor for any reason.
A-1APPENDIX ASPECIFICATIONSGENERALPATIENT SAFETYDesigned to meet the requirements of CSA 22.2 and UL 2601.Defibrillator protection up to 5 KV.POWER REQUIREMENTSOperating Voltages 86 to 265 VACFrequency 47 to 65 Hz.Power Consumption, Maximum < 100 Watts.BATTERYType Lithium IonOperation Time At least eight (8) hours.DIMENSIONSHeight WPU: 6.5 inches (16.5 cm) for the roll around design, 6inches (15.2 cm) for the table mount design.PCU: 5 inches (12.7 cm).DCU: 12 inches (30.5 cm).Width WPU: 16.3 inches (41.4 cm).PCU: 8.7 inches (22.1 cm).DCU: 15.9 inches (40 cm).Depth WPU: 15.7 inches (39.9 cm).PCU: 3.85 inches (9.8 cm).DCU: 6.2 inches (15.75 cm).Weight WPU: 15 lbs (6.8 kg).PCU: 1.5 lbs (0.6804 kg).DCU: 17.7 lbs (8 kg).DISPLAYType 800 x 600 pixel color LCD.Screen Size 12 inch (30.5 cm) diagonal.Sweep Speed 25 or 50 mm/S gives 9.2 S or 4.6 S of displayrespectively. For respiration, a speed of .33, 1.56, 3.13,6.25, 12.5 or 25 mm/S is used.Waveform Display Mode Fixed Trace, Moving Erase Bar.Waveform Display Height >/= 21 mm."Full-Screen" Display Height >/= 84 mm.Display Bandwidth 33 Hz.
A-2RECORDER (Thermal Array Recorder)Chart Speeds 25 or 50 mm/second.Paper Type and Size Non-Grid Thermal Paper, 50 mm wide.Alphanumeric annotation of date, time delay, paper speed, scales, lead configuration, patientmode, NIBP (systolic, mean, diastolic), heart rate, respiration rate, Et, FiCO2, Agents Et,Agents Fi and SpO2.Automatic activation on alarm with alarm parameter printed at the beginning of trace.DISPLAYED PARAMETERSTime Battery-backed quartz crystal clock.Alarms High and low limits selectable on patient parameters.ECG ECG Waveform Scale, displayed lead.Heart Rate Normally derived from ECG. May be manually selected to bederived from pulse oximeter, NIBP or automatically selected inorder of priority.Pulse Oximeter Pulse Rate, Pulse waveform, percent saturation.Respiration Rate Respiration rate derived from EtCO2.CO2 Both EtCO2 and Inspired CO2.N2O Inspired N2O, EtN2O available in Agent MAC Box.O2 Inspired, expired (averaged percent).Agents Automatic ID of Agent (Isoflurane, Halothane or Sevoflurane)displaying both End-Tidal Inspired Fraction Concentrations (Etand Fi)).NIBP Pressures (systolic, mean, diastolic), pulse rate, status.Trace Freeze Trace A.
A-3ECG CHANNELECG AMPLIFIERProtected against defibrillator and electrosurgery potentials. Standard Lead Configurations II.Lead Fail Active, sensing signal imbalance.HEART RATERange 30 to 300 bpm.Accuracy ±0.5%, ±1 bpmResolution 1 bpm.CARDIOTACHSensitivity Adults: >200 uV minimum.Neonates: >100 uV minimum.Pacemaker Pulse Rejection Meets requirements of AAMI EC13-1983standard for cardiac monitors (Pacer Rejectmode).Bandwidth Monitor: 0.5 to 40 Hz.ALARMSLower Alarm Limit 30 to 249 bpm (or Off).Upper Alarm Limit 60 to 249 (or Off).TEST/CALIBRATIONSquare Wave Test Waveform 60 bpm ±1 bpm.Calibration Signal 1 mV ±10%.
A-4NON-INVASIVE BLOOD PRESSUREGENERAL Oscillometric method (with inflatable cuff).Determines systolic, diastolic and mean arterialpressures, and pulse rate.Patient Types Adult and Neonate.PNEUMATIC SYSTEMCuff Inflation Pressure Initially 170 mmHg for Adult/Pediatric. (120mmHg for Neonate). Subsequent inflationpressures determined by last measured systolicpressure.Cuff Inflation Pressure Range Adult: 110 to 265 mmHg.Neonate: 80 to 135 mmHg.Overpressure Protection Automatically releases cuff pressure if inflationpressure exceeds 285 mmHg (adult, forneonate: 150 absolute or greater than 142 butless than 150 for 15 seconds).MEASUREMENT RANGESystolic 25 to 260 mmHg.Diastolic 10 to 235 mmHg.Mean Arterial 10 to 255 mmHg.(Measurements are possible only in pulse rate range of 40 to 200 bpm for adult and 40 to 230bpm for neonate.)ACCURACYPulse Rate 2% full scale.Pressure Zero Offset 20 mmHg, ±5 mmHg.Pressure Span Accuracy ±3 mmHg.Pressure Transducer Range 0 to 307 mmHg.ALARM LIMITSSystolic, Mean and Diastolic Minimum: 5 to 249 mmHg.Maximum: 5 to 249 mmHg.Pulse (when "HR" derived from NIBP) Minimum: 30 to 249 bpm.Maximum: 60 to 249 bpm.MODESManual Immediate upon operator command.Automatic Determinations automatically made withselectable intervals of 1, 2, 2.5, 3, 5, 10, 15, 20,30 and 45 minutes, and 1, 2 and 4 hours.STAT Up to five (5) consecutive measurements (five(5) minute maximum time duration).
A-5END-TIDAL CO2 (Optional)TECHNIQUESide Stream, non-dispersive infrared (NDIR) absorption technique. Including water trapfiltration system and microprocessor logic control of sample handling and calibration.Measurement Range (after maximum warm-up period)CO2: 0 to 76 mmHg.N2O: 5 to 100 %.Accuracy (after 15 minute warm-up andmean airway O2 at 30% concentration)CO2: ±3mmHg or 12% (whichever is greater).N2O: ±2% Vol., +8% relative (at volumesgreater than 5%).Zero Drift CO2: 1 mmHg/Hr.N2O: < 2%/Hr to < 5%/24Hr.Calibration Interval Zero Cal: Automatic or user requestable.Flow Rate 230 mL/min (high flow) ±40mL/min.Response Time (assuming a gas flow of 230mL/min for a step change of between 10 to90%)CO2: < 700mS.Respiration Rate: 4 to 60 Breaths/minute.NOTEThis is the breath rate range in which the system measures the respiration rate within theaccuracy requirements for respiration rate.Relevant Interference 0.5 mmHg equivalent with 37.5 °C saturatedwith H2O (0.1% relative max).Operating Temperature 15 °C to 35 °C.Ambient Pressure Compensation Range 523 to 788 mmHgALARM LIMITSEtCO2 Alarm Limits Lower: Off or 5 to 60 mmHg.Upper: 5 to 80 mmHg or Off.Inspired CO2 25 mmHg (Fixed).N2O 80% (Fixed).
A-6PULSE OXIMETERPitch of pulse tone is modulated by saturation value.Saturation Range With Invivo Sensors: 1 to 100%.Saturation Accuracy ±3 digits at 70 to 100%.Pulse Range 20 to 300 bpm.Pulse Accuracy ±3 counts.ALARM LIMITSSpO2 Alarm Limits Minimum: 50 to 99 or Off.Maximum: 70 to 99 or Off.PULSE Alarm Limits (when "HR" derivedfrom SpO2)Minimum: 30 to 249.Maximum: 60 to 249.
A-7Anesthetic Agents (Optional)Technique Side Stream, non-dispersive infrared (NDIR) absorption technique.Measurement Range (after maximum warm-up period)Halothane: 0.15 to 6.0 Vol. %.Isoflurane: 0.15 to 6.0 Vol. %.Sevoflurane: 0.15 to 9.0 Vol. %.Carbon Dioxide: 0 to 76 mmHg.Nitrous Oxide: 5 to 100 Vol. %.Accuracy Halothane: ±0.15 Vol. % + 12% relative,.Isoflurane: ±0.15 Vol. % + 12% relative.Sevoflurane: ±0.15 Vol. % + 12% relative.Carbon Dioxide: (measured with agent option) ±3mmHg or 12%,whichever is greater.Nitrous Oxide: (measured with agent option) ±2% Vol., + 8%relative (at volumes greater than 5%)NOTEGas measurement performance requirements are met after the maximum warm-up period.Zero Drift Rate CO2 < 1mmHg/Hr.N2O < 2%/Hr to < 5%/24Hr maximum.Calibration Interval Calibration verification (as described in service instructions) shouldbe performed on a six (6) month interval.Flow Rate 230 ±40 mL/min (High Flow).Response Time (assuming a gas flow of 230 mL/min for a step change of between 10 to 90%)Agents: Not specified.CO2: < 700 mSec.Respiration Rate (Range permitting specified gas accuracy):4 to 20 rpm (Respirations per Minute).Respiration Rate: 4 to 60 rpm (based on CO2 measurements).NOTEThis is the breath rate range in which the system measures the respiration rate within theaccuracy requirements for respiration rate.Relevant Interference 0.5 mmHg equivalent with 37.5 °C saturated with H2O (0.1%relative max).Display Resolution: 0.01% Volume.Operating Temperature 15°C to 35°C.Maximum Warm-up Time: 20 minutes (10 minutes for in-spec measurements).Auto ID Threshold: (refer to paragraph 4.5.4 for warm-up information)0.15 ± Accuracy Vol % for all gases.Multiple Agents Alarm Threshold:The equivalent impurity of 0.3% volume or 30% of the primaryanesthetic agent gas (whichever is greater).NOTEExcept for combinations of Isoflurane and Sevoflurane, where the concentration of Sevoflurane thatshall trigger the agent mix alarm is 0.3%.
A-8Oxygen MonitoringRange 0 - 100 %.Signal Output (at constant temperature andpressure)14 ± 4 mV.Maximum Response Time (10 to 90%) 10 Seconds.Accuracy, Full Scale ± 3 %.NOTEGas measurement performance requirements are met after the maximum warm-up period.Accuracy, Full Scale, Over Operating Temperature ± 5 %.Drift < 1 % / Month.Linearity ± 1 % of Full Scale.Temperature Compensation Yes.Operating Temperatures 0 to +40 °C.Ambient Humidity (Non-Condensing) 0 - 99 % RH (Non-Condensing).Oxygen Sensor, Expected Life 12 months (> 100,000 Oxygen%/hours).Oxygen Sensor, Storage Temperature -10 to 45 °C.Oxygen Sensor, Shelf Life < 6 Months (in unopened bag).Interfering Gas Effects:N2OCO2HalothaneIsofluraneHeliumMethoxyfluraneDiethyl EtherTrichloroethyleneNitric Oxide< 2 Vol. % @ 80 Vol. % N2O.< 2 Vol. % @ 5 Vol. % CO2.< 2 Vol. % @ 4 Vol. % Halothane.< 2 Vol. % @ 5 Vol. % Isoflurane.< 2 Vol. % @ 50 Vol. % Helium.No Known Effects.< 2 Vol. % @ 50 Vol. % Diethyl Ether.No Known Effects.< 2 Vol. % @ 100 PPM Nitric Oxide.
A-9SYSTEM DEFAULTSMISCELLANEOUSAdult NeonateHeart Rate Source ECG ECGPatient Adult/Pediatric N/APacer Pulse Reject RejectTrace Speed 25 mm/second 25 mm/secondPulse Tone Source QRS QRSSound Volume Levels Alarm Tone: 4Heart Rate Tone: 4Key Click: 4Alarm Tone: 4Heart Rate Tone: 4Key Click: 4ECG 1Status On OnScale 15 mm/mV 15 mm/mVLead Configuration II IIFrequency Response Monitor MonitorSPO2Status On OnSize 40% (Relative) 40%Pulse Tone Source QRS QRSNON INVASIVE BLOOD PRESSUREAdult NeonateStatus On OnReading Mode Manual ManualReading Interval 3 Minutes 3 MinutesEtCO2Status Off OffAGENTSStatus Off Off
A-10SYSTEM DEFAULTSALARM LIMITSAdult NeonatalLow High Low HighHeart Rate 45 bpm 160 bpm 90 bpm 210 bpmNIBP Systolic 65 mmHg 190 mmHg 70 mmHg 100 mmHgNIBP Mean 55 mmHg 135 mmHg 40 mmHg 90 mmHgNIBP Diastolic 40 mmHg 125 mmHg 35 mmHg 50 mmHgSPO2 85 % Off 90 % 98 %ET Halothane Off 1.5 % Off 1.5 %Fi Halothane Off 2.2 % Off 2.2 %ET Isoflurane Off 2.3 % Off 2.3 %Fi Isoflurane Off 3.4 % Off 3.4 %ET Enflurane Off Off Off OffFi Enflurane Off Off Off OffET Sevoflurane Off 4.1 % Off 4.1 %Fi Sevoflurane Off 6.1 % Off 6.1 %ET Desflurane Off Off Off OffFi Desflurane Off Off Off OffFiO2 15 % 99 % 15 % 99 %CO2 Inspired (Fixed non-adjustable)N/A 25mmHg N/A 25mmHgN2O (Fixed non-adjustable) N/A 80 % N/A 80 %Respiration 4 rpm 40 rpm 30 rpm 70 rpmEtCO2 15 mmHg 60 mmHg 30 mmHg 45 mmHg
A-11SYSTEM DEFAULTSALARM MODESMode UnlatchedWindow Size 20%RECORDERTrace 1 Assignment ECG1Trace 2 Assignment OffTrace Time Delay 4 SecondsData Acquisition Interval 4 MinutesGRIDSEtCO2 OffSCREEN TRACE CHARACTERISTICSMode Fixed with moving erase bar
B-1APPENDIX BREPAIRAll repairs on products under warranty must be performed by Invivo personnel, or an authorizedInvivo Service and Repair Center. Unauthorized repairs will void the warranty.If a monitor fails to function properly or requires maintenance, contact Invivo Technical Serviceat 1-800-331-3220 during normal business hours EST or 24 hour emergency technical assistance.Invivo Technical Service will advise you of the corrective action required. If you are advised toreturn the monitor to Invivo for repair, please do the following:1 Obtain a Return Authorization Number. This will ensure proper routing and facilitatetimely repair of your monitor.2 Remove batteries and package the monitor with adequate protection. If available, use theoriginal carton and packing materials in which the monitor was shipped from Invivo.3 Include a brief description of the problem as well as the name, address and phone number ofthe person to be contacted for additional information.4 Include a purchase order with the monitor being returned if it is out of warranty; InvivoTechnical Services can advise you of your monitor's warranty status, if need be. Repairs will bemade at Invivo's current list price for the replacement part(s) plus a reasonable labor charge.5 Ship the monitor, transportation prepaid, to the location specified by your Invivo TechnicalService Representative with the Return Authorization Number written on the outside of theshipping carton. Repairs will be made, normally, within two weeks, and the monitor will bereturned to you prepaid.Technical Service DepartmentInvivo Corp.12601 Research ParkwayOrlando, FL 32826(407) 275-3220To ensure full reliability, it is recommended that all repairs be made by an Invivo AuthorizedService and Repair center. For repair at your facility, a competent individual experienced in therepair of monitors can repair the monitor if it is authorized by Invivo Technical Service prior tothe repair.CAUTIONNo repair should ever be undertaken or attempted by anyone not having a thorough knowledge ofthe repair of Invivo monitors. Only replace damaged parts with components manufactured or soldby Invivo. Contact the Invivo Technical Service and Repair Center for service and technicalassistance.
C-1APPENDIX CWARRANTYInvivo warrants this product, other than its expendable parts, to be free from defects in materialsand workmanship for a period of twelve (12) months from the date of original delivery to thebuyer or to buyer's order, provided that same is properly operated under conditions of normal use,and that periodic maintenance and service is performed. This same warranty is made for a periodof thirty (30) days on expendable parts. This warranty shall become null and void if product hasbeen repaired other than by Invivo, or if the product has been subject to misuse, accident,negligence or abuse.Invivo's sole obligation under this warranty is limited to repairing a product which has beenreported to Invivo's Technical Service Center during normal business hours and shippedtransportation prepaid. Invivo shall not be liable for any damages including but not limited toincidental damages, consequential damages or special damages.This warranty is in lieu of any other warranties, guarantees or conditions, includingmerchantability or fitness for a particular purpose. The remedies under this warranty are exclusiveand Invivo neither assumes nor authorizes anyone to assume for it any other obligation inconnection with the sale or repair of its products.INVIVO PRODUCTS CONTAIN PROPRIETARY COPY WRITTEN MATERIAL; ALLRIGHTS ARE RESERVED BY INVIVO CORP.
D-1APPENDIX DDECLARATION OF CONFORMITY For further information, contact the Regulatory Affairs Department of Invivo Corporation at telephone number 407-275-3220.
D-2
E-1APPENDIX EkPa to mmHg Conversion Chart1 kPa = 7.501 mmHgkPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg0.1 0.8 3.1 23.3 6.1 45.8 9.1 68.3 12.1 90.8 15.1 113.30.2 1.5 3.2 24.0 6.2 46.5 9.2 69.0 12.2 91.5 15.2 114.00.3 2.3 3.3 24.8 6.3 47.3 9.3 69.8 12.3 92.3 15.3 114.80.4 3.0 4.4 25.5 6.4 48.0 9.4 70.5 12.4 93.0 15.4 115.50.5 3.8 3.5 26.3 6.5 48.8 9.5 71.3 12.5 93.8 15.5 116.30.6 4.5 3.6 27.0 6.6 49.5 9.6 72.0 12.6 94.5 15.6 117.00.7 5.3 3.7 27.8 6.7 50.3 9.7 72.8 12.7 95.3 15.7 117.80.8 6.0 3.8 28.5 6.8 51.0 9.8 73.5 12.8 96.0 15.8 118.50.9 6.8 3.9 29.3 6.9 51.8 9.9 74.3 12.9 96.8 15.9 119.31.0 7.5 4.0 30.0 7.0 52.5 10.0 75.0 13.0 97.5 16.0 120.01.1 8.3 4.1 30.8 7.1 53.3 10.1 75.8 13.1 98.3 16.1 120.81.2 9.0 4.2 31.5 7.2 54.0 10.2 76.5 13.2 99.0 16.2 121.51.3 9.8 4.3 32.3 7.3 54.8 10.3 77.3 13.3 99.8 16.3 122.31.4 10.5 4.4 33.0 7.4 55.5 10.4 78.0 13.4 100.5 16.4 123.01.5 11.3 4.5 33.8 7.5 56.3 10.5 78.8 13.5 101.3 16.5 123.81.6 12.0 4.6 34.5 7.6 57.0 10.6 79.5 13.6 102.0 16.6 124.51.7 12.8 4.7 35.3 7.7 57.8 10.7 80.3 13.7 102.8 16.7 125.31.8 13.5 4.8 36.0 7.8 58.5 10.8 81.0 13.8 103.5 16.8 126.01.9 14.3 4.9 36.8 7.9 59.3 10.9 81.8 13.9 104.3 16.9 126.82.0 15.0 5.0 37.5 8.0 60.0 11.0 82.5 14.0 105.0 17.0 127.52.1 15.8 5.1 38.3 8.1 60.8 11.1 83.3 14.1 105.8 17.1 128.32.2 16.5 5.2 39.0 8.2 61.5 11.2 84.0 14.2 106.5 17.2 129.02.3 17.3 5.3 39.8 8.3 62.3 11.3 84.8 14.3 107.3 17.3 129.82.4 18.0 5.4 40.5 8.4 63.0 11.4 85.5 14.4 108.0 17.4 130.52.5 18.8 5.5 41.3 8.5 63.8 11.5 86.3 14.5 108.8 17.5 131.32.6 19.5 5.6 42.0 8.6 64.5 11.6 87.0 14.6 109.5 17.6 132.02.7 20.3 5.7 42.8 8.7 65.3 11.7 87.8 14.7 110.3 17.7 132.82.8 21.0 5.8 43.5 8.8 66.0 11.8 88.5 14.8 111.0 17.8 133.52.9 21.8 5.9 44.3 8.9 66.8 11.9 89.3 14.9 111.8 17.9 134.33.0 22.5 6.0 45.0 9.0 67.5 12.0 90.0 15.0 112.5 18.0 135.0
E-21 kPa = 7.501 mmHg.kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg18.1 135.8 21.1 158.3 24.1 180.8 27.1 203.3 30.1 225.8 33.1 248.318.2 136.5 21.2 159.0 24.2 181.5 27.2 204.0 30.2 226.5 33.2 249.018.3 137.3 21.3 159.8 24.3 182.3 27.3 204.8 30.3 227.3 33.3 249.818.4 138.0 21.4 160.5 24.4 183.0 27.4 205.5 30.4 228.0 33.4 250.518.5 138.8 21.5 161.3 24.5 183.8 27.5 206.3 30.5 228.8 33.5 251.318.6 139.5 21.6 162.0 24.6 184.5 27.6 207.0 30.6 229.5 33.6 252.018.7 140.3 21.7 162.8 24.7 185.3 27.7 207.8 30.7 230.3 33.7 252.818.8 141.0 21.8 163.5 24.8 186.0 27.8 208.5 30.8 231.0 33.8 253.518.9 141.8 21.9 164.3 24.9 186.8 27.9 209.3 30.9 231.8 33.9 254.319.0 142.5 22.0 165.0 25.0 187.5 28.0 210.0 31.0 232.5 34.0 255.019.1 143.3 22.1 165.8 25.1 188.3 28.1 210.8 31.1 233.3 34.1 255.819.2 144.0 22.2 166.5 25.2 189.0 28.2 211.5 31.2 234.0 34.2 256.519.3 144.8 22.3 167.3 25.3 189.8 28.3 212.3 31.3 234.8 34.3 257.319.4 145.5 22.4 168.0 25.4 190.5 28.4 213.0 31.4 235.5 34.4 258.019.5 146.3 22.5 168.8 25.5 191.3 28.5 213.8 31.5 236.3 34.5 258.819.6 147.0 22.6 169.5 25.6 192.0 28.6 214.5 31.6 237.0 34.6 259.519.7 147.8 22.7 170.3 25.7 192.8 28.7 215.3 31.7 237.8 34.7 260.319.8 148.5 22.8 171.0 25.8 193.5 28.8 216.0 31.8 238.5 34.8 261.019.9 149.3 22.9 171.8 25.9 194.3 28.9 216.8 31.9 239.3 34.9 261.820.0 150.0 23.0 172.5 26.0 195.0 29.0 217.5 32.0 240.0 35.0 262.520.1 150.8 23.1 173.3 26.1 195.8 29.1 218.3 32.1 240.8 35.1 263.320.2 151.5 23.2 174.0 26.2 196.5 29.2 219.0 32.2 241.5 35.2 264.020.3 152.3 23.3 174.8 26.3 197.3 29.3 219.8 32.3 242.3 35.3 264.820.4 153.0 23.4 175.5 26.4 198.0 29.4 220.5 32.4 243.0 35.4 265.520.5 153.8 23.5 176.3 26.5 198.8 29.5 221.3 32.5 243.8 35.5 266.320.6 154.5 23.6 177.0 26.6 199.5 29.6 222.0 32.6 244.5 35.6 267.020.7 155.3 23.7 177.8 26.7 200.3 29.7 222.8 32.7 245.3 35.7 267.820.8 156.0 23.8 178.5 26.8 201.0 29.8 223.5 32.8 246.0 35.8 268.520.9 156.8 23.9 179.3 26.9 201.8 29.9 224.3 32.9 246.8 35.9 269.321.0 157.5 24.0 180.0 27.0 202.5 30.0 225.0 33.0 247.5 36.0 270.0
F-1APPENDIX FLIST OF SYMBOLS

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