ICU Medical 20709 LifeCare PCA Infusion System with Hospira MedNet User Manual FlagstaffBook

Hospira, Inc. LifeCare PCA Infusion System with Hospira MedNet FlagstaffBook

Users Manual

430-04685-001 (Rev. 7/05)SystemOperatingManual ®For Use With List 20709
430-04685-001 (Rev. 7/05)Change HistoryTitle Description of Change Pages Affected430-04685-001 (Rev. 6/05)This draft was reviewed by Ken Hsu, JoAnn Fujii, May 20, 2005.All430-04685-001 (Rev. 7/05) • The tables in Chap-ter 10 were revised.• The IEC 60601-1 refer-ence added.• Print Event History Log revised.• Updating Drug Library (Sect.6-3) added.10-2 and 10-31-22B-26-9
i430-04685-001 (Rev. 7/05) TABLE OF CONTENTSSECTION 1DESCRIPTIVE INFORMATION . . . . . . . . . . . . . . . . . . 1-11.1 PRODUCT DESCRIPTION . . . . . . . . . . . . . . . . . . . 1-21.2 INDICATIONS FOR USE . . . . . . . . . . . . . . . . . . . . . 1-3patient selection . . . . . . . . . . . . . . . . . . . . . . . . 1-3user qualifications . . . . . . . . . . . . . . . . . . . . . . . 1-31.3 CONTRAINDICATIONS FOR USE . . . . . . . . . . . . . . 1-41.4 CONVENTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5warnings, cautions, and notes . . . . . . . . . . . . . 1-61.5 DEFINITIONS (GENERAL AND CLINICAL) . . . . . . . . 1-71.6 PRECAUTIONS AND WARNINGS . . . . . . . . . . . . . 1-12unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13programming . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14loading dose/dose limits . . . . . . . . . . . . . . . . . 1-14operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17epidural administration . . . . . . . . . . . . . . . . . . 1-17battery operation . . . . . . . . . . . . . . . . . . . . . . . 1-18sets and accessories . . . . . . . . . . . . . . . . . . . 1-19electrical artifacts . . . . . . . . . . . . . . . . . . . . . . 1-20interconnecting of medical equipment . . . . . . 1-221.7 GUIDANCE ON EMC COMPATIBILITY . . . . . . . . . 1-221.8 FCC INFORMATION . . . . . . . . . . . . . . . . . . . . . . 1-23us fcc statement . . . . . . . . . . . . . . . . . . . . . . . 1-23fcc interference statement . . . . . . . . . . . . . . . . 1-23radio frequency exposure statement . . . . . . . . 1-24SECTION 2PRINCIPLES OF OPERATION. . . . . . . . . . . . . . . . . . . 2-12.1 FEATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3drug recognition . . . . . . . . . . . . . . . . . . . . . . . . 2-3modes of delivery . . . . . . . . . . . . . . . . . . . . . . . 2-3Page
ii Table of Contents430-04685-001 (Rev. 7/05) programming . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4biomedical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4other features . . . . . . . . . . . . . . . . . . . . . . . . . . 2-42.2 ADMINISTRATION EQUIPMENT . . . . . . . . . . . . . . . 2-5SECTION 3EQUIPMENT DESCRIPTION . . . . . . . . . . . . . . . . . . . . 3-13.1 FRONT PANEL . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23.2 VIAL CRADLE ASSEMBLE . . . . . . . . . . . . . . . . . . . 3-33.3 REAR PANEL . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-43.4 OPERATING BUTTONS & KEYS . . . . . . . . . . . . . . . 3-5SECTION 4BASIC OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14.1 GUIDED START UP FOR PREFILLED VIALS . . . . . . 4-24.2 GUIDED START UP FOR CUSTOM VIALS . . . . . . . . 4-84.3 GETTING STARTED . . . . . . . . . . . . . . . . . . . . . . 4-15unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15connecting the patient pendant . . . . . . . . . . . . 4-16system self-tests . . . . . . . . . . . . . . . . . . . . . . . 4-16data retention . . . . . . . . . . . . . . . . . . . . . . . . . 4-174.4 OPERATING THE PCA INFUSER . . . . . . . . . . . . . 4-18intravenous pca infuser administration . . . . . . 4-18epidural pca infuser administration . . . . . . . . . 4-194.5 LOADING A VIAL . . . . . . . . . . . . . . . . . . . . . . . . 4-214.6 ADJUSTING SETTINGS . . . . . . . . . . . . . . . . . . . . 4-23changing alarm volume . . . . . . . . . . . . . . . . . . 4-24changing contrast of main display . . . . . . . . . . 4-25changing or confirming time and date . . . . . . . 4-264.7 NEW PATIENT . . . . . . . . . . . . . . . . . . . . . . . . . . 4-294.8 PURGING THE SYSTEM . . . . . . . . . . . . . . . . . . . 4-304.9 LOADING DOSE . . . . . . . . . . . . . . . . . . . . . . . . . 4-32
LifeCare PCA Infusion System iii430-04685-001 (Rev. 7/05)SECTION 5SELECT MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15.1 MODES OF DELIVERY . . . . . . . . . . . . . . . . . . . . . 5-2protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2pca only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2continuous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3pca+continuous . . . . . . . . . . . . . . . . . . . . . . . . . 5-35.2 PCA ONLY MODE . . . . . . . . . . . . . . . . . . . . . . . 5-45.3 CONTINUOUS MODE . . . . . . . . . . . . . . . . . . . . . . 5-95.4 PCA+CONTINUOUS MODE . . . . . . . . . . . . . . . . 5-135.5 PROTOCOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-185.6 DOSE LIMIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21programming the 4 (or 1) hour dose limit . . . . 5-22programming a dose limit . . . . . . . . . . . . . . . . 5-22programming no dose limit . . . . . . . . . . . . . . . 5-24clearing or changing a dose limit . . . . . . . . . . . 5-255.7 CLEARING THE HISTORY AND/OR RX SETTINGS . 5-285.8 USING REVIEW/CONFIRMATION SCREENS . . . . . 5-295.9 CHANGING SETTINGS DURING SETUP . . . . . . . . 5-30stopping infusion . . . . . . . . . . . . . . . . . . . . . . . 5-30turning the infuser off . . . . . . . . . . . . . . . . . . . 5-305.10 MAKING CHANGES AFTER SETUP . . . . . . . . . . 5-31reviewing the current settings . . . . . . . . . . . . . 5-31changing settings . . . . . . . . . . . . . . . . . . . . . . 5-31changing the cca . . . . . . . . . . . . . . . . . . . . . . . 5-335.11 CLEARING SHIFT TOTALS . . . . . . . . . . . . . . . . 5-345.12 CHANGING A VIAL . . . . . . . . . . . . . . . . . . . . . . 5-355.13 ADDING A SUPPLEMENTAL LOADING DOSE . . . . 5-375.14 CHECKING HISTORY & SETTINGS . . . . . . . . . . . 5-385.15 HISTORY AND EVENT LOG . . . . . . . . . . . . . . . . 5-40
iv Table of Contents430-04685-001 (Rev. 7/05) SECTION 6ADVANCED PROGRAMMING WITH HOSPIRA MEDNETTM SOFTWARE . . . . . . . . . 6-16.1 GUIDED START-UP USING HOSPIRA MEDNET TM SOFTWARE . . . . . . . . . . . 6-26.2 SELECT CCA . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-86.3 UPDATING THE DRUG LIBRARY . . . . . . . . . . . . . . 6-96.4 SOFT LIMIT OVERRIDE . . . . . . . . . . . . . . . . . . . 6-116.5 HARD LIMIT VIOLATION . . . . . . . . . . . . . . . . . . . 6-116.6 IMPORTANT SYMBOLS . . . . . . . . . . . . . . . . . . . . 6-12no rule sets . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12soft limit override . . . . . . . . . . . . . . . . . . . . . . . 6-12wireless . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-136.7 AUTOPROGRAMMING . . . . . . . . . . . . . . . . . . . . . 6-14SECTION 7TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . 7-17.1 STATUS MESSAGES . . . . . . . . . . . . . . . . . . . . . . 7-27.2 INFUSER ALARM SYSTEM . . . . . . . . . . . . . . . . . . 7-47.3 SILENCING AN ALARM . . . . . . . . . . . . . . . . . . . . . 7-57.4 ALARMS AND MESSAGES . . . . . . . . . . . . . . . . . . . 7-67.5 INFUSER STALLING . . . . . . . . . . . . . . . . . . . . . . . 7-9SECTION 8MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18.1 INFUSER STORAGE . . . . . . . . . . . . . . . . . . . . . . . 8-28.2 CLEANING AND SANITIZING . . . . . . . . . . . . . . . . . 8-28.3 BATTERY MAINTENANCE . . . . . . . . . . . . . . . . . . . 8-58.4 SERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6SECTION 9SPECIFICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19.1 STORED OCCLUSION VOLUME . . . . . . . . . . . . . . . 9-59.2 TIME FROM OCCLUSION TO ALARM . . . . . . . . . . . 9-59.3 DELIVERY RATE ACCURACY . . . . . . . . . . . . . . . . 9-5trumpet curves . . . . . . . . . . . . . . . . . . . . . . . . . 9-6example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-69.4 TRUMPET CURVES . . . . . . . . . . . . . . . . . . . . . . . 9-8
LifeCare PCA Infusion System v430-04685-001 (Rev. 7/05)SECTION 10PRESCRIPTION DELIVERY LIMITS . . . . . . . . . . . . . 10-1APPENDIX AGENERATING BAR CODE LABELS (HOSPIRA MEDNETTM SOFTWARE ENABLED) . . . . A-1example of label layout & sample . . . . . . . . . . . a-3label diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . a-4APPENDIX BNETWORK PRINTER SETUP. . . . . . . . . . . . . . . . . . . . B-1printing event history log . . . . . . . . . . . . . . . . . . b-2downloading logs to a pc . . . . . . . . . . . . . . . . . . b-3APPENDIX CWARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1APPENDIX DCONTACT INFORMATION . . . . . . . . . . . . . . . . . . . . . . D-1INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1
vi Table of Contents430-04685-001 (Rev. 7/05)
LifeCare PCA Infusion System 1- 1430-04685-001 (Rev. 7/05)Section 1Descriptive InformationThe latest patient controlled analgesia (PCA) offered by Hospira, LifeCare PCA® Infusion System with Hospira MedNetTM Software, allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits. The PCA Infusion System is used in a wide range of clinical settings that includes but is not limited to the following:MEDICAL LABOR/DELIVERY/POST PARTUMBURN UNITSURGICAL OPERATING ROOM ONCOLOGYCRITICAL CARE UNITS POST ANESTHESIA CARE UNIT (PACU)PEDIATRICS
1- 2 Descriptive Information430-04685-001 (Rev. 7/05) 1.1 Product DescriptionThe primary features of the PCA Infuser device are Hospira MedNetTM Software and the bar code reader that are designed to enhance patient safety and automate drug identification. Other enhancements include new programming features and the ability to read pharmacy-generated bar codes.The PCA Infusion System includes a microprocessor based infusion device with keypad controls, patient pendant, a bar coded drug vial, and a compatible administration set (see Administration Equipment on page 2- 5 for list of compatible sets). The infuser has an Ethernet port for computer or printer connections. The software is field upgradeable. It is intended to operate on AC power, but an internal battery is provided to maintain operation for short periods of time when AC power is not available. The vials are single-use, bar coded, and prefilled with a prescription drug by Hospira/Abbott, or the vials are sterile and empty to be custom-filled by the hospital pharmacy. The PCA Infuser offers the following modes of delivery:•PCA ONLY•CONTINUOUS ONLY•PCA+CONTINUOUSThe PCA Infuser is able to store frequently used prescriptions called protocols. The protocols are available for Hospira/Abbott prefilled vials and custom syringes. The protocols must be set up by a hospital-designated authority in the Biomed Mode or through Hospira MedNetTM Software (if enabled).
LifeCare PCA Infusion System 1- 3430-04685-001 (Rev. 7/05)1.2 Indications for UseThe LifeCare PCA® Infusion System with Hospira MedNetTM Software is intended for accurate, volumetric, infusion of analgesic drugs by continuous or patient demanded intravenous administration. It is intended for short-term continuous (less than 96 hours) epidural administration of analgesic drugs.WARNINGFor epidural use, administer only anesthetics/analgesics approved for epidural administration (asindicated or allowed by the drugs’ FDA approvedlabeling). Epidural administration of drugs other thanthose indicated for epidural use could result in seriousinjury to the patient.PATIENT SELECTIONPatients selected to use the PCA Infuser should be able to understand the relationship between pain and pushing the PCA Infuser patient pendant for pain relief. Patients selected for the use of the PCA Infuser should be able to physically self-administer a PCA dose using the patient pendant.WARNINGPatient Pendant Is only to be pressed by the patient.USER QUALIFICATIONSAll clinicians should be appropriately trained to program the PCA Infuser prior to use.The PCA Infuser is intended for use at the direction or under the supervision of licensed physicians or certified health care professionals. Clinicians must be trained in infuser use, administration of parenteral and epidural fluids and drugs, and the prevention of related IV complications and precautions to prevent accidental infusion of air. Training should
1- 4 Descriptive Information430-04685-001 (Rev. 7/05) emphasize the assessment and monitoring of patients receiving potent analgesic medications, and the appropriate treatment for possible adverse reactions.1.3 Contraindications For UseThe PCA Infuser should not be used for patient controlled analgesia by patients who do not have the cognitive ability to understand the use of self-administered pain medication, nor have the physical capacity to operate the patient pendant, if required.Drugs not compatible with silicone rubber or PVC plastic, or drugs not stable under infusion conditions should not be used with this system.
LifeCare PCA Infusion System 1- 5430-04685-001 (Rev. 7/05)1.4 ConventionsThis section describes the conventions used throughout this manual:Convention Application ExampleITALIC REFERENCE TO A SECTION, FIGURE, OR TABLE.(See Front Panel on page 3-2..)[BRACKETED ALL-CAPS] KEYS OR BUTTONS ON THE DEVICE ARE DISPLAYED IN [BRACKETED ALL-CAPS] OR WITH A GRAPHIC.[ON/OFF]OR ITALIC SMALLCAPS>SOFTKEY OPTIONS PREVIOUS>INITIAL CAPS LOWERCASE SCREEN DISPLAYS AND DEVICE LABELS (AS APPROPRIATE)SELECT DELIVERY MODEBOLD EMPHASIS ...SETS ARE SUPPLIED STERILE AND ARE FOR....
1- 6 Descriptive Information430-04685-001 (Rev. 7/05) WARNINGS, CAUTIONS, AND NOTESAlert Messages used throughout this manual are described below. Pay particular attention to these messages.WARNINGA Warning Message contains special safety emphasisand must be observed at all times. Failure to observea Warning Message is potentially life threatening.CAUTION: A CAUTION usually appears in front of aprocedure or statement. It contains information thatcould prevent irreversible product damage orhardware failure. Failure to observe a CAUTION couldresult in serious patient or user injury.NOTE: A Note highlights information that helps explain a concept or procedure.This symbol directs the user to consult accompanying documents.NOTE: Figures are rendered as graphic representations to approximate the actual product. Therefore, figures may not exactly reflect the product.
LifeCare PCA Infusion System 1- 7430-04685-001 (Rev. 7/05)1.5 Definitions (General and Clinical)TERMS DEFINITIONSAccuracy The degree to which the instrument is capable of delivering the volume of analgesic drug that is displayed or targeted to be delivered. Accuracy shall be specified as the maximum allowable delivery error from a targeted or displayed value (see Section 9 Specifications on page 9- 1).Autoprogramming Complete or partial program received from a bar code enabled Point-of-Care System requiring clinician confirmation prior to administration.Battery Fault A battery that will not accept a full charge.Bolus A fixed amount of drug delivered in a short amount of time. A PCA dose.Button A hard key on the front panel or on the patient pendant.Clinical Care Area (CCA)An area of the hospital that authorized hospital staff is permited to use specific drugs. The clinician selects a CCA after turning on the infuser. The hospital may create from one to eighteen CCA’s.Connectivity Engine (CE)A component of the infuser that controls Ethernet and wireless communication between the network server and infuser.Continuous Infusion program characterized by a constant, fixed-rate dose.
1- 8 Descriptive Information430-04685-001 (Rev. 7/05) Custom Syringeor VialA bar coded Hospira/Abbott sterile empty vial that is custom-filled by a pharmacy.Default Drug Library (DDL)A pre-programmed drug library embedded in the infuser software. The infuser uses the DDL until a User-defined Drug Library is installed and supersedes the DDL.Dose Limit User-programmable parameter specifying the maximum amount of drug that can be administered via PCA dose and continuous delivery in a programmable rolling time period consisting of discrete accumulation periods of 6 minutes. NOTE: Dose Limit periods are specified as 1 and 4 hours on an infuser with the DDL; on infusers with a User-defined Drug Library, the dose limit periods can be defined as 1, 4, 6, or 12 hours.Drug Library DownloadThe process of moving the User-defined Drug Library from the network server to the infuser.Drug Library InstallationThe process of moving the User-defined Drug Library from the CE to the infuser.History Displays Rx Settings, PCA Summary and the Event Log. Hospira MedNetTM SoftwareNetwork based application software used to upload event logs and download the user-defined drug library to the infuser.TERMS DEFINITIONS
LifeCare PCA Infusion System 1- 9430-04685-001 (Rev. 7/05)Infusing The infuser is ON and a DELIVERY SCREEN is displayed. The infusing mechanism may or may not be actually infusing at any given time.LCD Liquid Crystal DisplayLED Light Emitting DiodeLoading Dose An optional dose programmed during Setup before entering the program.The loading dose can be administered at any time by the clinician during the programmed therapy. For more information see Loading Dose on page 4- 32.Lockout Interval A programmed time interval specifying the minimum time that must pass after a loading dose or PCA dose (bolus) is administered; this time interval specifies when the next PCA dose can begin infusing. Bolus requests made during the lock out interval are denied.Muting Period The period between the silencing of an alarm by pressing the [SILENCE] key and the resumption of the alarm.Occlusion A blockage in the PCA Infuser set that prevents the infuser from pumping fluid into the patient. Possible causes of occlusions are kinked or plugged non-patent IV tubing.Occlusion PressureThe maximum pressure produced as a result of an occlusion in the PCA Infuser set.TERMS DEFINITIONS
1- 10 Descriptive Information430-04685-001 (Rev. 7/05) On The infuser is turned on using either A/C or battery power. The infuser is not necessarily pumping when ON.Patient Pendant A hand held pendant connected to the infuser that allows the patient to request a PCA dose (bolus) by pressing a button.PCA Mode Infusion therapy characterized by bolus doses administered on patient demand subject to a lockout interval and, optionally, a dose limit.PCA Set Tubing connecting the PCA Vial to the patient.PCA Vial Vial compatible with the infuser that is either prefilled with drug by Abbott or Hospira (standard vial) or filled by the hospital pharmacy (custom vial).Prime Manually removing air from the syringe and line.Purge The process during which the pumping mechanism is run to remove air from the PCA set.Rule Set A list of upper, lower, soft and/or hard limits for delivery parameters. Rule sets reside in the User-Defined Drug Library and are associated with a specific vial within a CCA.TERMS DEFINITIONS
LifeCare PCA Infusion System 1- 11430-04685-001 (Rev. 7/05)Rx Settings The current programmed therapy. Includes PCA Dose, PCA Lockout Interval, Continuous Rate, Loading Dose and Dose Limit amount.Soft Keys The five keys to the right of the device’s LCD display. Each key’s function is dependent on the screen displayed data.Stored Protocols Frequently used therapy settings stored in the infuser's memory. Stored protocols can be recalled again, making it unnecessary for the operator to program the same therapy settings each time they are needed. Stored protocols are determined by the health care facility.Standard Syringe A prefilled bar coded drug vial in which the infuser identifies the drug and concentration. The drug and concentration are found in the Drug Library by using the bar code on the vial. Standard syringes are also known as prefilled drug vials.User-defined Drug LibraryA drug library that contains hospital defined clinical care areas (CCAs) and rule sets created with Hospira MedNetTM Software.Warning An indication to advise the clinician of a possible dangerous condition. TERMS DEFINITIONS
1- 12 Descriptive Information430-04685-001 (Rev. 7/05) 1.6 Precautions and WarningsUNPACKINGProduct damage may occur unless proper care is exercised during the unpacking and setup process. The battery may not be fully charged upon receipt.
LifeCare PCA Infusion System 1- 13430-04685-001 (Rev. 7/05)GENERALThis section addresses general safety and operational procedures.•Possible explosion hazard exists if used in the presence of flammable anesthetics.WARNINGPossible explosion hazard exists if the infuser is usedin the presence of flammable anesthetics.•Potent analgesic medications are used with this device. Refer to drug package insert for precautions and possible adverse reactions.•Refer to analgesic package enclosure for possible incompatibil-ity with fluid or drug being delivered through the IV line.•Coupling together of more than one infuser into one patient line may significantly affect the infusion rate of at least one of the infusers.•Do not use sharp objects such as pens, scissors, or fingernails to press keys. Such objects may damage keys and cause a malfunction.•Arrange tubing, cords, and cables to minimize the risk of patient strangulation or entanglement.•Failure to use Hospira/Abbott vials and Hospira/Abbott PCA Infuser sets with the integral anti-siphon valve may cause an inaccurate dose delivery to the patient.•The system must be primed prior to purging. Remove all air from vial before placing it into the infuser.•Always close the slide clamp on the PCA Infuser administration set before removing or the replacing syringe, and before discon-tinuing infusion.•Patient must be disconnected from the PCA Infuser set before the purge cycle.•Vial and injector must be securely locked into the infuser before beginning delivery.
1- 14 Descriptive Information430-04685-001 (Rev. 7/05) PROGRAMMINGThis section presents known infuser programming cautions.WARNINGFor custom syringes, confirm that the displayedconcentration (mg/mL) or (mcg/mL) exactly matchesthe concentration value and drug name on the syringe.If they do not match, under/overdosage may result.•In the CONTINUOUS and PCA+CONTINUOUS modes, if a purge is not performed after a syringe change, the infuser auto-matically performs a small system compliance step to remove slack when the [START/PAUSE] key is pressed (with the door locked). Although, fluid is not normally delivered to the patient during the compliance step, under some conditions up to 0.3 mL of fluid may be delivered. If 0.3 mL of fluid represents a haz-ard to the patient, disconnect the set during this operation.•At flow rates less than 0.5 mL/hr, there may be a significant delay before flow is established if the system is not purged.•Selections are rounded up to the nearest tenth of a digit for mg/mL values or to the nearest digit for mcg/mL values.LOADING DOSE/DOSE LIMITSThis section presents Loading Dose and Loading Dose information and cautions.•The loading dose is always included in the total dose delivered.•Setting a new dose limit will not erase the previous dose history.•Always monitor the PCA Infuser when delivering medication with the door open.•Patient Pendant is only to be pressed by the intended patient.WARNINGPatient Pendant is only to be pressed by the patient.
LifeCare PCA Infusion System 1- 15430-04685-001 (Rev. 7/05)OPERATIONThis section presents operational information and cautions.•Perform close assessment and monitoring of patients receiving potent analgesic medication for possible adverse reactions.•The PCA Infuser is not intended to be used for frequent, long-term portable operation. Keep plugged into a properly grounded AC receptacle whenever possible, and reserve battery power for temporary portable operation and emergency backup. If the AC receptacle is in doubt, use battery power.
1- 16 Descriptive Information430-04685-001 (Rev. 7/05) MAINTENANCEThis section addresses infuser maintenance.•Always confirm that the bar code reader window is clean. Blood, fingerprints, condensation, and other elements may obstruct the view of the bar code reader. Elements on the win-dow (other than scratches) can be cleaned by using one of the recommended cleaning solutions. See Section 8 Maintenance on page 8-1.•Window scratches cannot be wiped clean and will probably lead to window replacement. •To avoid mechanical or electrical damage, do not immerse the infuser in any fluids or cleaning solutions.•Some cleaning and sanitizing compounds may slowly degrade components made from some plastic materials. Using abrasive cleaners or cleaning solutions not recommended by Hospira may result in product damage. Do not use compounds contain-ing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride.•Do not sterilize by heat, steam, ETO, or radiation.•Do not place the PCA Infuser in service if it fails the self-test.•Hospira will be responsible for the safety effect, reliability, and performance of this device only if: adjustments, modifications, or repairs are performed by persons authorized by Hospira; the electrical setup at the point of use complies with appropriate local requirements; and the device is used in accordance with the instructions for use identified in this operating manual.•Hospital policies and guidelines must always be followed to ensure patient safety and to minimize the potential for patient hazards.
LifeCare PCA Infusion System 1- 17430-04685-001 (Rev. 7/05)ALARMSThis section presents alarm information.•If the MALFUNCTION Alarm Message is seen and sounds, press the [ON/OFF] key to turn the infuser off. Then turn the infuser back on. If the malfunction alarm repeats, remove the infuser from service.EPIDURAL ADMINISTRATIONThis section contains epidural administration information.•Recommended use of the epidural route is to provide anesthe-sia or analgesia for periods up to 96 hours.•It is strongly recommended that the epidural infusion system be prominently identified as EPIDURAL. Failure to identify the infu-sion system as epidural could result in incorrect administration of intravenous rather than epidural formulations. In addition, failure to identify the epidural infusion system could result in confusion with other infusion systems delivering concomitant intravenous formulations.•This device can be used to administer only those anesthetics/analgesics approved for epidural administration (as indicated or allowed by the drugs’ FDA approved labeling). Epidural admin-istration of drugs other than those indicated for epidural use could result in serious injury to the patient.•For epidural administration, the use of infuser sets without Y-sites, and epidural stickers indicating ongoing epidural adminis-tration are recommended.•Administration of drugs via the epidural route should be limited to personnel familiar with associated techniques and patient management problems. Proper epidural placement of the cath-eter is essential since catheter migration could result in intra-vascular or intrathecal administration. Facilities practicing epidural administration must be equipped with resuscitative equipment, oxygen, naloxone, and other resuscitative drugs. Adequate monitoring equipment is recommended for continu-ous monitoring of the patient during epidural administration. Patients must be observed frequently for side effects in a fully-equipped and staffed environment for at least 24 hours follow-ing completion of drug administration by the epidural route.
1- 18 Descriptive Information430-04685-001 (Rev. 7/05) CAUTION: Delayed respiratory depression followingcontinuous epidural administration of preservative-free morphine sulfate has been reported.•The epidural space has 58 openings through which fluid can exit. Pressure buildup during administration is transient. How-ever, if a large volume of fluid is administered over a short time period, the pressure will take longer to return to normal. If over delivery occurs during administration, observe the patient closely for signs of spinal cord compression (disorientation, headache, transient neuralgias) and drug overdose.BATTERY OPERATIONThis section documents battery information.WARNINGUnplug the AC power cord before removing the battery door.CAUTION: When the PCA Infuser is connected to apatient, do not operate the PCA Infuser with thebattery removed. Use of a properly maintained andcharged battery helps ensure proper operation. •The battery may not be fully charged upon receipt. Connect the PCA Infuser to AC power for at least 16 hours.•Use AC power whenever possible. Connect to AC power during storage to ensure a fully charged battery during a power outage.•Always connect the infuser to a properly grounded receptacle unless battery operation is desired. If quality earth grounding source is in doubt, use battery power.•If the low-battery alarm sounds, connect to AC power immediately.
LifeCare PCA Infusion System 1- 19430-04685-001 (Rev. 7/05)SETS AND ACCESSORIESUse Hospira/Abbott LifeCare PCA® Set List 6517 whenever the infuser is in CONTINUOUS or PCA+CONTINUOUS Modes.•When using PCA or PCA+CONTINUOUS Mode, another fluid line may be attached to the distal backcheck Y site. Use Hos-pira/Abbott LifeCare PCA® Infuser set, List 3559, 6516, or a combination of List 6514 and 6517.•It is recommended that highly viscous solutions and drugs, col-loidal suspensions, and emulsions should not be delivered through the inline backcheck valve of the PCA Infuser set. Valve functionality may be compromised by the presence of residue.•Refer to vial and set package inserts for precautions and infor-mation on proper handling.
1- 20 Descriptive Information430-04685-001 (Rev. 7/05) ELECTRICAL ARTIFACTSThis section addresses electrical artifacts and their remedies.•Nonhazardous, low-level electrical potentials are commonly observed when fluids are administered using infusion devices. These potentials are well within accepted safety standards, but may create artifacts on voltage-sensing equipment such as ECG, EMG, and EEG machines. These artifacts vary at a rate that is associated with the infusion rate. If the monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes, these artifacts may be accentuated so as to simulate actual physiological signals. To determine if the abnormality in the monitoring equipment is caused by the infusion device instead of some other source in the environment, set the infusion device so that it is temporarily not delivering fluid. Disappearance of the abnormality indicates that it was probably caused by the electronic noise generated by the infusion device. Proper setup and maintenance of the monitoring equipment should eliminate the artifact. Refer to the appropriate monitoring equipment system documentation for setup and maintenance instructions.•The PCA Infusion System is designed to operate normally in the presence of most encountered electromagnetic interference (EMI) conditions. In the event of extreme levels of interference, such as those encountered next to an electrosurgical generator, it is possible that the normal operation of a sensor or microcom-puter might be disrupted. Even in this event, the outcome would likely be a false alarm or detected system malfunction and would not result in a hazard to the patient or clinician.•This equipment has been tested and found to comply with the EMC limits for the Medical Device Directive 93/42/EEC (EN 55011 Class B and IEC/EN 60601-1-2:2001). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The equipment generates, uses, and can radiate radio frequency energy, and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity. How-ever, there is no guarantee that interference will not occur in a particular installation. If this equipment causes harmful interfer-ence with radio, television, or other devices, which can be determined by turning the equipment off and on, the user is
LifeCare PCA Infusion System 1- 21430-04685-001 (Rev. 7/05)encouraged to try to correct the interference by one or more of the following measures:•Reorient or relocate the receiving device•Increase the separation between the equipment•Connect the equipment into an outlet on a circuit different from that to which the other device(s) is connected•Consult the manufacturer or field service technician for help•Portable and mobile RF communications equipment, such as cellular telephones, 2-way radios, Bluetooth devices, microwave ovens, in close proximity to this device may affect wireless and wired communications with the infusion pump and/or the operation of the infusion pump. Special precautions need to be exercised regarding EMC, These include:•Use of a shielded Ethernet cable (CAT5 STP or better) for plugging into the RJ45 Ethernet connector. Using an unshielded Ethernet cable may result in increased emissions.•Maintaining a minimum separation distance of 2 ½ ft between the infusion pump system and portable/mobile RF communica-tions equipment•List Number 20709 is compliant to IEC/EN 60601-1-2 (2001) and have been tested and found to comply with EMC limits for the Medical Device Directive 93/42/EEC (EN 55011 Class B and IEC/EN 60601-1-2:2001).For more information see Appendix D Contact Information on page D- 1.
1- 22 Descriptive Information430-04685-001 (Rev. 7/05) INTERCONNECTING OF MEDICAL EQUIPMENTAccessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC Standards (e.g. IEC 60950 for data processing equipment and IEC 60601-1 for Medical Equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the signal input or output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system Standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative.1.7 Guidance on EMC Compatibility•There is a shared responsibility between manufacturers, cus-tomers, and users to ensure that medical equipment and sys-tems are designed and operated as intended. Medical electrical equipment requires precautions regarding electromagnetic compatibility, and must be installed and used according to the electromagnetic compatibility information provided in this manual.•The device is suitable for use in all establishments, including domestic establishments. If extended operation during power mains interruption is needed, use battery power.•Always manage the electromagnetic environment. •The guidance included in this manual provides information needed to•Determine the device’s suitability for use in the intended environment.•Manage the electromagnetic environment to permit the device to perform as intended without disturbing other equipment.•Separate the device from all other electronic equipment. If the device must be used near other electrical equipment, monitor the equipment to ensure there is no electromagnetic interference.
LifeCare PCA Infusion System 1- 23430-04685-001 (Rev. 7/05)•Devices should not be used adjacent to or stacked with other equip-ment. If the device must be used adjacent to or stacked with other equipment, monitor the devices to verify normal operation.•USE ONLY components specifically labeled for use with the PCA Infusion System to help ensure the device operates as intended.•If you suspect external RF sources or other equipment are influ-encing device operation, contact the Biomedical Engineering Department for additional guidelines concerning electromag-netic immunity.•Contact the Biomedical Engineering Department for additional information in the technical service manual concerning operat-ing devices near RF sources. 1.8 FCC InformationFCC ID: STJ-20709US FCC (FEDERAL COMMUNICATIONS COMMISSION) STATEMENT•This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause interference, and (2) This device must accept any interference, including that may cause undesired operation of this device.FCC INTERFERENCE STATEMENT•This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installa-tion. This equipment generates, uses, and can radiate radio fre-quency energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio commu-nications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception,
1- 24 Descriptive Information430-04685-001 (Rev. 7/05) which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures:•Reorient or relocate the receiving antenna.•Increase the distance between the equipment and the receiver.•Connect the equipment to an outlet on a circuit different from that to which the receiver is connected. •Consult the dealer or an experienced radio/TV technician for help. •Changes or modifications not expressly approved by Hospira could void the user's authority to operate the equipment.RADIO FREQUENCY EXPOSURE STATEMENT•The Wireless LAN radio device in the Connectivity Engine peripheral board with this infusion device has been evaluated and found compliant to the requirements of the following Radio Frequency exposure standards:•Federal Communications Commission, OET Bulletin 65 (Edition 97-01), Supplement C (Edition 01-01), Evaluating Compliance with FCC Guidelines for Human Exposure to Radio frequency Electromagnetic Fields, July 2001.•Industry Canada, Evaluation Procedure for Mobile and Portable Radio Transmitters with respect to Health Canada's Safety Code 6 for Exposure of Humans to Radio Frequency Fields, Radio Standards Specification RSS-102 Issue 1 (Provisional): September 1999.•The radiated output power of this Wireless LAN device is far below the FCC radio frequency exposure limits. The Wireless LAN device has been evaluated with one inch separation of human body from the antenna and found to be compliant with FCC RF exposure limits.
LifeCare PCA Infusion System 2- 1430-04685-001 (Rev. 7/05)Section 2Principles of OperationThe PCA Infuser is a portable infusion pump that allows a patient to self-administer analgesia within programmed limits as well as providing continuous infusion of a desired drug. Generally, a clinician following a physician’s order programs the infuser with operating parameters, which may include the following:•Drug Dose and Concentration•Loading Dose•Delivery Mode Setting •PCA •CONTINUOUS•PCA+CONTINUOUS•PCA Dose•Lockout Interval•Rate of Continuous Flow•1 or 4 Hour Dose Limit (factory setting 4-hour when using DDL)•Protocols (Hospital configured programs stored in the infuser)Available operating parameters and their allowed ranges are determined based on the confirmed vial and the delivery mode selected. The loading dose and dose limits are optional. This programmed flexibility allows the physician to tailor an effective pain management program unique to each patient.
2- 2 Principles of Operation430-04685-001 (Rev. 7/05) The PCA Infuser may be programmed to deliver the following:• PCA doses (PCA Mode)• Continuous background infusion with no PCA doses permitted (CONTINUOUS Mode).• Continuous rate and PCA doses (PCA+CONTINUOUS Mode).Analgesic drugs may be delivered through the PCA Infuser intravenously by any of the three modes cited above. In addition, Preservative-Free Morphine Sulfate Injection, USP, or other approved analgesic drugs can be administered epidurally through a recommended Low Priming Volume PCA Set without a Y-adapter. The epidural route may be used to provide analgesia by any of the three modes of infuser operation.A lockout Interval controls the frequency that a patient may receive a PCA dose of analgesic. If the infuser is set in the PCA or PCA+CONTINUOUS Mode, the patient may request a bolus of analgesic during therapy by pressing the patient pendant button; this causes the infuser to release the specified bolus of analgesic into the IV line. After a Loading or Supplemental Loading Dose delivery, the patient cannot receive any additional patient requested boluses until the lockout interval has elapsed, assuming the dose limit has not been exceeded (see Dose Limit on page 5- 21).The alarm system sounds an audible alarm to alert the user of various conditions or a malfunction (see Alarms and Messages on page 7- 6).
LifeCare PCA Infusion System 2- 3430-04685-001 (Rev. 7/05)2.1 FeaturesThe following features are addressed in this section:•Drug Recognition•Modes Of Delivery•Programming•Battery•Biomedical•Options•Other FeaturesDRUG RECOGNITION•Bar code reader identifies drug name and concentration in the vial (prefilled Hospira/Abbott vials only).•Bar code reader identifies the drug name and concentration of custom-filled vials when appropriate pharmacy-generated bar codes are used and Hospira MedNetTM Software is enabled.MODES OF DELIVERY•PCA Only•Continuous•PCA + Continuous
2- 4 Principles of Operation430-04685-001 (Rev. 7/05) PROGRAMMING•Keypad with large numbers, decimal point & icons for easy use•Prompting alphanumeric displayBATTERY•8 V Battery•Battery for emergency backup and temporary portable operation (approx. 2.5 hrs.)BIOMEDICAL•RJ-45 Ethernet Connector•Software is Field Upgradable•Diagnostic Setup Options•Alarm History•Ability to Store Protocols for Hospira/Abbott Prefilled Vials and Custom (Sterile Empty) Vials•Nurse Call Relay ConnectorOPTIONS•Infusion HistoryOTHER FEATURES•Prefilled and Sterile Empty Vials•Wireless Antenna•Autoprogramming•Microprocessor Control•Liquid Crystal Display (LCD) and Light-Emitting Diode (LED) Display•Panel Back Illumination•Security Features
LifeCare PCA Infusion System 2- 5430-04685-001 (Rev. 7/05)2.2 Administration EquipmentThe following sets may be used in any delivery mode. The following sets are supplied sterile and are for single use only administration sets:** See the current product sales catalog for available drugs and sets **List 3559:PCA Set, Mini-Bore with Integral Anti-Siphon Valve-SL 170 cm. Approximate priming volume 2.3 mL. For use in PCA mode via intravenous route.List 6514:PCA Extension Set with Backcheck Valve-SL 25 cm. Approximate priming volume 1.1 mL. For use in conjunction with Set 6517 to convert from Continuous to PCA Mode via Intravenous route.List 6516:PCA Set-Long, Mini-Bore with Integral Anti-Siphon Valve-SL 218 cm. Approximate Priming Volume 2.6 mL. For use in PCA Mode when extra length needed via Intravenous route.List 6517:PCA Continuous Infusion Set, Mini-Bore with Integral Anti-Siphon Valve-SL 203 cm. Approximate Priming Volume 1.5 mL. For use in Continuous and PCA+Continuous Modes via intravenous route. For use in PCA, Continuous, and PCA + Continuous modes via epidural route.
2- 6 Principles of Operation430-04685-001 (Rev. 7/05)
LifeCare PCA Infusion System 3 - 1430-04685-001 (Rev. 7/05)Section 3Equipment DescriptionThe following subjects are addressed in this section:• Front Panel • Vial Cradle Assemble •Rear Panel • Operating Buttons & Keys
3 - 2 Equipment Description430-04685-001 (Rev. 7/05) PCA3.1 Front PanelSecurity DoorVialVial Cradle ClipsBar code Reader WindowCradle Release Mechanism (Holder) LEDDisplayLCDDisplayDoorLockSoftkeysKeypadButtonsAC PowerIndicatorBattery Power IndicatorInjector
LifeCare PCA Infusion System 3 - 3430-04685-001 (Rev. 7/05)3.2 Vial Cradle AssembleCradle Release MechanismVial BaseVial CradleClipsVial StopperVial LipInjectorInjector Flange (Vial Plunger)Luer-Lock FitmentBar code Reader Window (vial bar code must face toward window)Upper VialRetainerVial SensorSwitch(Top VialCradle Clip)Lower VialRetainer(MiddleBracket)InjectorFlangeRetainerInjectorSensorSwitch (backof retainer)WirelessAntenna
3 - 4 Equipment Description430-04685-001 (Rev. 7/05) 3.3 Rear PanelPatient Pendant JackGround Test PointNurse Call Jack PatientPendantPatient Pendant Cable FastenerPatient Pendant(blue handle)Universal IV Pole Clamp with Dual LockTMNOTE: Pole Clamp is locked when security door is closed and locked. Unit cannot be removed from IV pole without key.Battery and Fuse Access DoorAC Cord ConnectorStabilizer footEthernet Jack/ Printer Connecto
LifeCare PCA Infusion System 3 - 5430-04685-001 (Rev. 7/05)3.4 Operating Buttons & KeysThe [ON/OFF] Button controls the power of the PCA Infuser. The [CLEAR] Button is used to clear an entry.The [ENTER] Button is used to select and accept various screen options.The [EXIT] Button is used to return to the main display from non-programming screens.The [SILENCE/VOLUME] Button is used to temporarily silence an alarm while correcting a condition to temporarily silence an alarm while correcting a condition, to temporarily mute the keypad for two minutes, or to adjust alarm volume when the infuser is in run mode.
3 - 6 Equipment Description430-04685-001 (Rev. 7/05) The [START/PAUSE] Button is used to start or pause a continuous infusion or PCA bolus.The [HISTORY] Button is used to display parameter settings, dose history, review Rx, and review the event log. It also provides access to the Print History Softkey (Hospira MednetTM Software not enabled).The numeric Buttons are used to enter values for any field requiring numeric data.The [DECIMAL POINT] Button is used for entering numbers with a decimal point. An example would be 10.5 mg.
LifeCare PCA Infusion System 3 - 7430-04685-001 (Rev. 7/05)Keys (or Softkeys) are touchkeys which are located to the right of the main display. They perform a variety of functions correlating to the description displayed on the screen.An example of a softkey in this manual is PCA ONLY>.Battery indicator illuminates continuously when infuser is running on battery power.AC (mains) power indicator illuminates when infuser is plugged into AC power.LED displays the dose delivered.When displaying dose delivery in micrograms, a vertical “walking stick” appears on the right side of the display. When displaying dose delivering in milligrams, the “walking stick” appears on the left side of the display.
3 - 8 Equipment Description430-04685-001 (Rev. 7/05) PCA Patient Pendant is used by the patient to deliver the drug upon the press of the button.WARNINGPATIENT PENDANT ISONLY TO BE PRESSEDBY THE PATIENT.If the Patient Pendant is partially pressed, a Pendant Fault Message will appear. This can be corrected by releasing the button. A PCA bolus will not be delivered during a Pendant Fault condition.The Ethernet port connects to a local area network. The Nurse Call Jack provides remote notification of an alarm event.
LifeCare PCA Infusion System 4- 1430-04685-001 (Rev. 7/05)Section 4 Basic OperationThe following subjects are addressed in this section:•Guided Start up for Prefilled Vials•Guided Start up for Custom Vials•Getting Started•Operating the PCA Infuser•Loading a Vial•Adjusting Settings•New Patient•Purging the System•Loading Dose
4- 2 Basic Operation430-04685-001 (Rev. 7/05) 4.1 Guided Start up for Prefilled Vials1. Press BUTTON, or load drug vial into cradle, to power on the infuser. See Loading a Vial on page 4-21. Upon initial start-up, the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.This screen is followed by another screen displaying self-test information that includes the following: time, date, software version and copyright data. During the self-test, the infuser reads the bar code label.2. Select CONTINUE> to advance to the next screen.LIFECARE PCASELF TESTLifeCare PCASELF TESTCOMPLETERAM . . . . . OKFLASH . . . OKCPU ID . . . OKCPU . . . . . OKTIMER . . . .OKSYSTEMSETTINGSCONTINUE
LifeCare PCA Infusion System 4- 3430-04685-001 (Rev. 7/05)The NEW PATIENT SCREEN appears if the infuser has been off for 4 hours or less. Select YES> or NO>.3. If NO> is selected, the History and Rx settings are kept. 4. If the YES> option is selected, the History and Rx settings are cleared. Select CONFIRM> to confirm choice and continue. A screen appears to confirm that History was cleared.5. Select CONFIRM> to accept the inserted drug, or remove the vial if it is not correct. New Patient?YesNoHISTORY ANDRX SETTINGSCLEAREDMORPHINE PF1 mg/mL CONFIRM 1 mg/mL MO RPH INE PF TO RX REMOVE VIAL IF NOT CORRECTCONFIRM
4- 4 Basic Operation430-04685-001 (Rev. 7/05) 6. Select either YES> or NO> to purge the system.See Purging the System on page 4-30 for more information.7. If YES> is selected, disconnect the set from the patient, and press and hold the PURGE> Softkey.While purging is occurring, the word PURGING is displayed.NOTE: Purging is recommended to remove system slack when a new vial is inserted. The maximum volume delivered during a purge is 3mL.Upon release of the PURGE> Softkey, the display asks if the purge is complete.8. Select YES> to continue, or select NO> to purge again until complete.9. After purging is complete, reconnect set to patient. MORPHINE PF1 mg/mL PURGE? PURGING RECOMENDEDYESNOMORPHINE PF1 mg/mL DISCONNECT SET FROM PATIENT PRESS AND HOLD PURGE KEYPURGEPREVIOUS PURGE COMPLETE?MORPHINE PF1 mg/mLYESNO
LifeCare PCA Infusion System 4- 5430-04685-001 (Rev. 7/05)10. Set Loading Dose (if desired) by selecting YES>. See Loading Dose on page 4-32 for more information.11. Enter a Loading Dose within the displayed range.Then press .12. The DELIVER LOADING DOSE NOW SCREEN allows the option of delivering the loading dose now or after the programming is complete. SET LOADING DOSE?YESNOMORPHINE PF1 mg/mLMORPHINE PF1 mg/mL ENTER LOADING DOSE THEN PRESS ENTER BUTTON0.1 - 10 mg 2 mgmilligramsPREVIOUSENTER DELIVER LOADING DOSE NOW?YESDELIVER LATERMORPHINE PF1 mg/mL
4- 6 Basic Operation430-04685-001 (Rev. 7/05) 13. If YES> was selected, press the BUTTON to infuse the programmed Loading Dose. NOTE: The loading dose mode is the only mode that the infuser will deliver with the door unlocked.WARNINGAlways monitor the infuser when delivering medicationwith the door unlocked.14. If the DELIVER LATER option is selected, the screen advances to the SELECT DELIVERY MODE SCREEN.15. The screen displays the amount of analgesic delivered as it infuses. The bottom of the screen displays text confirming that the Loading Dose is being delivered. Upon completion, the red LED (above the LCD) displays the amount delivered. PRESS START BUTTON TO INFUSE 1 mg LOADING DOSEPREVIOUSMORPHINE PF1 mg/mLMORPHINE PF1 mg/mL PRESS PAUSE BUTTON TO STOP1 mgmilligramsINFUSING LOADING DOSE
LifeCare PCA Infusion System 4- 7430-04685-001 (Rev. 7/05)16. The SELECT MODE SCREEN appears. See Modes of Delivery on page 5-2 for more information.MORPHINE PF1 mg/mL SELECT DELIVERY MODEPCA ONLYPCA + CONT.CONTINUOUSPROTOCOLSPREVIOUS
4- 8 Basic Operation430-04685-001 (Rev. 7/05) 4.2 Guided Start up for Custom VialsNOTE: Custom vials without pharmacy-generated bar codes can only be used with the default drug library. Press BUTTON, or load drug vial into cradle,to power on the infuser. See Loading a Vial on page 4-21. Upon initial start-up, the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.This screen is followed by another screen displaying self-test information that includes the following: time, date, software version and copyright data. During the self-test, the infuser reads the bar code label.1. Select CONTINUE> to advance to the next screen.LIFECARE PCASELF TESTLifeCare PCASELF TESTCOMPLETERAM . . . . . OKFLASH . . . OKCPU ID . . . OKCPU . . . . . OKTIMER . . . .OKSYSTEMSETTINGSCONTINUE
LifeCare PCA Infusion System 4- 9430-04685-001 (Rev. 7/05)1. The NEW PATIENT SCREEN appears if the infuser has been off for 4 hours or less. Select YES> or NO>.2. If NO> is selected, the History and Rx settings are kept. 3. If the YES> option is selected, the History and Rx settings are cleared. Select CONFIRM> to confirm choice and continue. A screen appears to confirm that History was cleared.NOTE: An Alpha Vial is a type of sterile empty vial that can be customized by your hospital pharmacy. New Patient?YesNoHISTORY ANDRX SETTINGSCLEARED
4- 10 Basic Operation430-04685-001 (Rev. 7/05) 4. Select CONFIRM> to accept the inserted drug, or remove the vial if it is not correct.5. Select either YES> or NO> to purge the system.See Purging the System on page 4-30 for more information.6. If YES> is selected, disconnect the set from the patient, and press and hold the PURGE> Softkey.While purging is occurring, the word PURGING is displayed.NOTE: Purging is recommended to remove system slack when a new vial is inserted. The maximum volume delivered during a purge is 3mL.ALPHA VIAL CONFIRM CUSTOM VIAL TO RX REMOVE VIAL IF NOT CORRECTCONFIRMALPHA VIAL PURGE?PURGING RECOMMENDEDYESNOALPHA VIAL DISCONNECT SET FROM PATIENT PRESS AND HOLD PURGE KEYPURGEPREVIOUS
LifeCare PCA Infusion System 4- 11430-04685-001 (Rev. 7/05)Upon release of the PURGE> Softkey, the display asks if the purge is complete.7. Select YES> to continue, or select NO> to purge again until complete.8. After purging is complete, reconnect set to patient. 9. Select desired units of measure.For the demonstration purposes Micrograms is selected. PURGE COMPLETE?ALPHA VIALYESNOALPHA VIAL SELECT UNITS OF MEASUREMILLIGRAMSMICROGRAMS(mg)(mcg)
4- 12 Basic Operation430-04685-001 (Rev. 7/05) 10. Enter desired drug concentration within the displayed range.NOTE: Only whole numbers may be entered when using micrograms (mcg). If a decimal entry is attempted, the display will inform the user that the decimal point is not allowed. Press [CLEAR] to zero the value. Then enter a whole value within the displayed range.11. Then press .12. Confirm the drug concentration by selecting CONFIRM>.13. Set Loading Dose (if desired) by selecting YES>. See Loading Dose on page 4-32 for more information.ALPHA VIAL ENTER DRUG CONCENTRATION THEN PRESS ENTER BUTTONPREVIOUS1-100 mcg/mL10microgramsmcgmLENTERALPHA VIAL10 mcg/mL CONFIRM 10 mcg/mL CONCENTRATION TO PHYSICIAN RXCONFIRMPREVIOUS SET LOADING DOSE?YESNOALPHA VIAL10 mcg/mL
LifeCare PCA Infusion System 4- 13430-04685-001 (Rev. 7/05)14. Enter a Loading Dose within the displayed range.Then press .15. The DELIVER LOADING DOSE NOW SCREEN allows the option of delivering the loading dose now or after the programming is complete.16. If YES> was selected, press the BUTTON to infuse the programmed Loading Dose. NOTE: The loading dose mode is the only mode that the infuser will deliver with the door unlocked.ALPHA VIAL10 mcg/mL ENTER LOADING DOSE THEN PRESS ENTER BUTTON1 - 100 mcg 20 mcgmicrogramsPREVIOUSENTER DELIVER LOADING DOSE NOW?YESDELIVER LATERALPHA VIAL10 mcg/mL PRESS START BUTTON TO INFUSE 20 mcg LOADING DOSEPREVIOUSALPHA VIAL10 mcg/mL.
4- 14 Basic Operation430-04685-001 (Rev. 7/05) WARNINGAlways monitor the infuser when delivering medicationwith the door unlocked.17. If the DELIVER LATER option is selected, the screen advances to the SELECT DELIVERY MODE SCREEN.18. The screen displays the amount of analgesic delivered as it infuses. The bottom of the screen displays text confirming that the Loading Dose is being delivered. Upon completion, the red LED (above the LCD) displays the amount delivered.The SELECT MODE SCREEN appears. See Modes of Delivery on page 5-2 for more information.ALPHA VIAL10 mcg/mL PRESS PAUSE BUTTON TO STOP15 mcgmicrogramsINFUSING LOADING DOSEALPHA VIAL10 mcg/mL SELECT DELIVERY MODEPCA ONLYPCA + CONT.CONTINUOUSPROTOCOLSPREVIOUS
LifeCare PCA Infusion System 4- 15430-04685-001 (Rev. 7/05)4.3 Getting StartedThis section details the PCA Infuser setup procedures.UNPACKINGInspect the PCA Infuser packaging for possible shipping damage. If damage is found, contact the delivery company immediately.Unpack the PCA Infuser carefully, and inspect the PCA Infuser thoroughly for damage. Retain the packing slip and save all packing material in case the PCA Infuser is damaged or fails the infuser self-test and has to be returned to Hospira.CAUTION: Carefully unpack and setup the PCAInfuser to avoid product damage. Do not use the PCAInfuser if it appears damaged in any way. The batterymay not be charged upon receipt.CAUTION: If the PCA Infuser appears to bedamaged, contact Hospira.
4- 16 Basic Operation430-04685-001 (Rev. 7/05) CONNECTING THE PATIENT PENDANTThe Patient Pendant should be plugged into the unit prior to programming.1. Connect Patient Pendant plug into the back of unit opening labeled Patient Pendant.2. Tighten connector ring snugly to confirm proper attachment.SYSTEM SELF-TESTSConnect the AC power (mains) cord to an AC power receptacle, then confirm that the power plug icon is illuminated on the front of the infuser. To verify readiness for operation, a systematic self-testing of the processing, delivery, and safety systems is performed whenever the PCA Infuser is turned on.CAUTION: Do not place the PCA Infuser in service ifit fails the system self-tests.NOTE: If the quality of the earth grounding source is in doubt, use battery power.Self-test failures are reported in the Malfunction Log as a Malfunction Condition.If an alarm occurs during the Power On Self-Test, identify the alarm message, then take corrective action (see section, Alarms and Messages on page 7- 6). Power the infuser ON. If the alarm recurs, remove the PCA Infuser from service and contact the hospital biomedical department or the local Hospira representative.Unlock the door and press the [ON/OFF] BUTTON, or insert the vial to turn the power on. Check the screen display and listen for a beep that indicates the audio is working. Wait for the self-tests to
LifeCare PCA Infusion System 4- 17430-04685-001 (Rev. 7/05)complete. If a vial was not previously inserted and the self-test was successful, put a vial (with a fully primed set) into the infuser.NOTE: When operating on battery power, a LOW BATTERY Message displays to prompt for an AC power connection.CAUTION: Do not operate the PCA Infuser with thebattery removed. Use of a properly maintained andcharged battery helps ensure proper operation. To ensure a fully charged battery, connect the PCA Infuser to AC power for a minimum of six hours while in the OFF MODE. DATA RETENTIONDelivery program settings and programming option selections are retained in memory unless erased.The infuser will automatically erase the program and the history if infuser is off for more than 4 hours. If the infuser is restarted after being off for 4 hour or less, the NEW PATIENT SCREEN allows the clinician to either keep the current program and history, or erase the program and history.The infuser has the capacity of recording up-to 20,000 events. The PCA Infuser displays up to 400 events by pressing the [HISTORY] Button. Events recorded include opening or closing of the security door, starting or stopping continuous infusion, an alarm condition, and so on. All event descriptions are preceded with time of occurrence.
4- 18 Basic Operation430-04685-001 (Rev. 7/05) 4.4 Operating the PCA InfuserThe following topics are addressed in this section:•Intravenous PCA Infuser Administration•Epidural PCA Infuser AdministrationINTRAVENOUS PCA INFUSER ADMINISTRATION1. Connect the syringe to the set and manually prime set.2. Attach primary IV set line to recommended PCA Infuser set, list #’s 3559, 6516, or 6517 attached to list 6514 via back-check valve port.3. Prime IV set and the lower portion of the PCA Infuser set, and close the manual clamp on the IV set.
LifeCare PCA Infusion System 4- 19430-04685-001 (Rev. 7/05)EPIDURAL PCA INFUSER ADMINISTRATIONNOTE: The administration of drugs is restricted to those analgesic drugs approved for continuous epidural administration.Recommended use of the epidural route is for labor and delivery, acute pain control, or post-operative analgesia for periods up to 96 hours.WARNINGIt is strongly recommended that the epidural infusionsystem be prominently identified as epidural. Failureto identify it as epidural may result in incorrectadministration of intravenous rather than epiduralformulations. In addition, failure to identify theepidural infusion could result in confusion with otherinfusion systems delivering concomitant intravenousformulations.For epidural use, administer only anesthetics/analgesics approved for epidural administration (asindicated or allowed by the drugs’ FDA approvedlabeling). Epidural administration of drugs other thanthose indicated for epidural use could result in seriousinjury to the patient.If a patient access device is not indwelling, prime and establish epidurally. Confirm proper placement. Attach recommended low priming volume infuser set, without Y-injection sites, to patient access device.CAUTION: Epidural administration of drugs by PCAInfuser and/or CONTINUOUS MODEs should belimited to personnel familiar with associatedtechniques and patient management problems.Proper epidural placement of the catheter is essentialsince catheter migration could result in intravascularand intrathecal administration. Facilities practicingcontinuous epidural administration must be equippedwith resuscitative equipment, oxygen, naloxone and
4- 20 Basic Operation430-04685-001 (Rev. 7/05) other resuscitative drugs. Adequate monitoringequipment is recommended for continuousmonitoring of the patient during epiduraladministration. Patients must be observed for side-effects frequently in a fully equipped and staffedenvironment for at least 24 hours followingcompletion of epidural drug administration. CAUTION: Delayed respiratory depression followingcontinuous epidural administration of preservative-free morphine sulfate has been reported.If over-delivery occurs during administration, observe the patient carefully for signs of the following:•Compression on spinal cord (disorientation, headache, or transient neuralgia)•Drug overdoseThe epidural space has 58 openings through which fluid can exit. Pressure build-up during administration is transient. However, if a large volume of fluid is administered over a short period, the pressure will take longer to return to normal.
LifeCare PCA Infusion System 4- 21430-04685-001 (Rev. 7/05)4.5 Loading a VialWARNINGFailure to use compatible Hospira/Abbott vial/injectorand Hospira/Abbott PCA Infuser sets with integral anti-siphon valve may cause an inaccurate dose delivery tothe patient.1. Squeeze Cradle Release Mechanism together at the top of the holder and move to the uppermost position.NOTE: Always verify that the bar code reader window is clean before inserting vial.2. When inserting bottom of glass vial into middle black bracket, ensure that the bar code label faces the bar code reader on the right side of the vial compartment.CAUTION: Do not positionvial into upper vial clip first.Vial lip may crack or chip.3. Insert bottom of glass vial into the middle black bracket.4. Gently press upper end of glass vial into upper black bracket.5. Squeeze the top of the Cradle Release Mechanism and move down until the vial injector snaps into the bottom bracket.6. Select CONTINUE>.7. If vial bar code is not read by the infuser, slowly rotate the vial and position with the bar code on the right until bar code has been read.DRUG NAME1423511
4- 22 Basic Operation430-04685-001 (Rev. 7/05) CAUTION: Vial and injector must be securely lockedinto the infuser before beginning delivery.WARNINGCracked vials may not show evidence of leakage untildelivery pressure is applied.NOTE: If the device is OFF, improper loading of syringe will turn the device ON and activate a non-silenceable CHECK SYRINGE alarm within 30 seconds after CONTINUE> is selected. Proper loading (engaging injector flange) silences the alarm.
LifeCare PCA Infusion System 4- 23430-04685-001 (Rev. 7/05)4.6 Adjusting Settings1. Press BUTTON to power on the infuser. Upon initial start-up, the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.2. Select SYSTEM SETTINGS> to viewthe Change Settings Menu.NOTE: Date and time may also be configured using the Hospira MedNetTM Software (if enabled). 3. Adjust settings by selectingthe appropriate softkey.LifeCare PCASELF TESTLifeCare PCASELF TESTCOMPLETERAM . . . . . OKFLASH . . . OKCPU ID . . . OKCPU . . . . . OKTIMER . . . .OKSYSTEMSETTINGSCONTINUE SELECT SETTI NG TO CHANGETIME/DATECONTRASTVOLUMECONTINUE
4- 24 Basic Operation430-04685-001 (Rev. 7/05) CHANGING ALARM VOLUME1. Select VOLUME>.2. Select desired volume, then SAVE & EXIT>.The current setting flashes at this screen. SELECT SETTI NG TO CHANGETIME/DATECONTRASTVOLUMECONTINUE SELECT ALARM VOLUMEHIGHLOWSAVE & EXITMEDIUMCANCEL
LifeCare PCA Infusion System 4- 25430-04685-001 (Rev. 7/05)CHANGING CONTRAST OF MAIN DISPLAY1. Select CONTRAST>.2. Select desired adjustmentsoftkey repeatedly until contrast is optimized for viewing.3. Select SAVE & EXIT>. SELECT SETTI NG TO CHANGETIME/DATECONTRASTVOLUMECONTINUE ADJUST LCD CONTRAST TO DESIRED LEVELDARKERLIGHTERSAVE & EXITCANCEL
4- 26 Basic Operation430-04685-001 (Rev. 7/05) CHANGING OR CONFIRMING TIME AND DATEWARNINGChanging the date or time will clear all totals. Thecurrent program will remain intact when the time/datefunction is accessed. Lockouts or limits in place whenthe time/date is changed will remain in effect.1. Select TIME/DATE>.After selecting TIME/DATE>, a warning screen appears to indicate that changing the date or time will clear all totals.NOTE: When Hospira MedNetTM Software is enabled on a network server, TIME/DATE is automatically updated when the infuser is on.2. When the WARNING SCREEN appears, select CONTINUE>.3. Set Time with number buttons. Enter hour as two digits (01:00) and minutes as two digits (01:07 PM).  SELECT SETTI NG TO CHANGETIME/DATECONTRASTVOLUMECONTINUEWARNING!CHANGING THE DATE OR TIME WILL CLEAR ALL TOTALS!CONTINUEPREVIOUS
LifeCare PCA Infusion System 4- 27430-04685-001 (Rev. 7/05)4. Select AM/PM> to alternate between AM and PM.NOTE: Time may be displayed using the 12 or 24 hour clock. The default setting is the 12 hour clock. The clock selection option is available in the Biomed Mode.5. After changing the time, select NEXT> to change the date. 6. To change the date, set the date with the Numbers Buttons.The current setting for Date will flash.NOTE: Date must be entered in MM/DD/YY sequence. SET TIME WITH NUMBERS BUTTONS TOGGLE AM/PM10:43 PMAM/PMNEXTNEXT SET DATE WITH NUMBERS BUTTONS01/15/01
4- 28 Basic Operation430-04685-001 (Rev. 7/05) 7. Select NEXT> again after changing to the desired date. The CONFIRMATION SCREEN appears. Select CONFIRM> to verify the changed settings.8. Then select CONTINUE> to exit the Change System Settings Menu and display the VIAL CONFIRMATION SCREEN (if the vial is loaded properly). CONFIRM CURRENT TIME AND DATE SETTINGS9:21 PM01/15/01CONFIRMCHANGECANCEL
LifeCare PCA Infusion System 4- 29430-04685-001 (Rev. 7/05)4.7 New Patient1. The NEW PATIENT SCREEN appears if the infuser has been off for 4 hours or less. Select YES> or NO>.NOTE: If the infuser has been off for 4 hours or less, the History and Rx settings are automatically cleared and the NEW PATIENT SCREEN is not shown.2. If YES> is selected, the History and Rx settings are cleared. If NO> is selected, the History and Rx settings are kept, and a screen appears offering the option to CLEAR HISTORY> or CONTINUE>.New Patient?YesNoHISTORY ANDRX SETTINGSCLEARED
4- 30 Basic Operation430-04685-001 (Rev. 7/05) 4.8 Purging the SystemWARNINGThe patient must be disconnected from the PCAInfuser set before the purge cycle.After the infuser is turned on and the self-tests are complete, the purge system prompt appears. Confirm that the PCA Infuser set is disconnected from the patient’s IV line before pressing YES> to initiate the purge cycle.To remove system slack when a new syringe is installed, we recommend purging the infuser before beginning operation.Press and hold the PURGE> key. The flow rate during purging is approximately 250 mL/hr. As soon as fluid is seen at the end of the administration set, and no air remains in the set, release the key. After the PURGE> key is released, the purge cycle will stop and the infuser prompts you to respond if flow was seen. If flow was not seen, the cycle may be repeated until a total of 3 mL has been delivered.NOTE: The infuser only allows the user to purge if Manual Purge is enabled in Biomed Mode. If it is disabled, purging is not an option.NOTE: Prime the system before purging. Remove all air from the syringe before loading it into the infuser.NOTE: Drug delivered during the purge cycle is not stored in system memory and will not be displayed.CAUTION: In Continuous and PCA+ContinuousModes, if a purge is not performed after a syringechange, the infuser automatically performs a smallsystem compliance step to remove slack when [Start]is pressed (with the door locked). Although, fluid is
LifeCare PCA Infusion System 4- 31430-04685-001 (Rev. 7/05)not normally delivered to the patient during thecompliance step, under some conditions up to 0.3 mLof fluid may be delivered. If 0.3 mL of fluid representsa hazard to the patient, disconnect the set during thisoperation.1. If YES> is selected, disconnect the set from the patient, and press and hold the PURGE> Softkey.NOTE: While purging is occurring, the word PURGING will be displayed.NOTE: Purging is recommended to remove system slack when a new vial is inserted. The maximum volume delivered during a purge is 3 mL.Upon release of the PURGE> Softkey, the display asks if the purge is complete.2. Select YES> to continue, or select NO> to purge again until complete.Reconnect set to patient.MORPHINE PF1 mg/mL DISCONNECT SET FROM PATIENT PRESS AND HOLD PURGE KEYPURGEPREVIOUS PURGE COMPLETE?YESNOMORPHINE PF1 mg/mL
4- 32 Basic Operation430-04685-001 (Rev. 7/05) 4.9 Loading DoseAfter the drug concentration has been confirmed, an optional loading dose may be programmed to provide an immediate bolus to the patient.1. Set Loading Dose (if desired) by selecting YES>.If NO> is selected, the screen advances to the SELECT MODE SCREEN. See Modes of Delivery on page 5-2 for information on modes.NOTE: A supplemental loading dose can also be delivered after the programming sequence is complete and infusing by opening the door and selecting the LOADING DOSE> key. 2. Enter a Loading Dose within the displayed range.3. Then press . SET LOADING DOSE?YESNOMORPHINE PF1 mg/mLMORPHINE PF1 mg/mL ENTER LOADING DOSE THEN PRESS ENTER BUTTON0.1 - 10 mg 2 mgmilligramsPREVIOUSENTER
LifeCare PCA Infusion System 4- 33430-04685-001 (Rev. 7/05)4. The next screen offers the options of infusing the loading dose now or later (after programming is complete). If DELIVER LOADING DOSE NOW ? is desired, press the YES> Softkey to infuse the programmed Loading Dose.5. If the DELIVER LATER option is desired, the screen advances to the SELECT DELIVERY MODE SCREEN. See Modes of Delivery on page 5-2 for more information.6. If YES> was selected, press the BUTTON to infuse the programmed Loading Dose. The screen displays the amount of analgesic delivered as it infuses. The bottom of the screen displays text confirming that the Loading Dose is being delivered. Upon completion, the red LED (above the LCD) displays the amount delivered.After delivery is complete, the SELECT MODE SCREEN appears. See Modes of Delivery on page 5-2. DELIVER LOADING DOSE NOW?YESDELIVER LATERMORPHINE PF1 mg/mL PRESS START BUTTON TO INFUSE 2 mg LOADING DOSEPREVIOUSMORPHINE PF1 mg/mL PRESS PAUSE BUTTON TO STOP0.5 mgmilligramsINFUSING LOADING DOSEMORPHINE PF1 mg/mL
4- 34 Basic Operation430-04685-001 (Rev. 7/05)
LifeCare PCA Infusion System 5 - 1430-04685-001 (Rev. 7/05)Section 5 Select ModeThis section addresses these topics:•Modes of Delivery •PCA Only Mode •Continuous Mode •PCA+Continuous Mode •Protocols •Dose Limit •Clearing the History and/or Rx Settings •Using Review/Confirmation Screens •Changing Settings During Setup •Making Changes After Setup •Clearing Shift Totals •Changing a Vial •Adding a Supplemental Loading Dose •Checking History & Settings •History and Event Log
5 - 2 Select Mode 430-04685-001 (Rev. 7/05) 5.1 Modes of DeliveryThe PCA Infuser delivers analgesia in one of three modes:•PCA ONLY•CONTINUOUS•PCA+CONTINUOUSPROTOCOLSProtocols for Hospira/Abbott prefilled drug vials and sterile empty vials are created in the Biomed Mode or through the Hospira MedNetTM Software. There are 10 stored protocols available (without Hospira MedNetTM Software enabled) or 90 stored protocols (5 per CCA) available (with Hospira MedNetTM Software enabled).PCA ONLYA patient initiated dose may be administered using the patient pendant when the PCA AVAILABLE Message appears. After completing the dose, the infuser enters either the preset LOCKOUT Interval or the DOSE LIMIT REACHED State (if a dose limit has been entered). Further delivery is prohibited in both of these conditions. Interrupting delivery by pressing [START/STOP], opening the door, loss of power, reaching the dose limit, emptying the vial, or a malfunction alarm may result in partial doses.The screen message alerts the user that the PCA Infuser is not available, and a different audible tone occurs if the patient pendant button is pressed (unless deactivated in Biomed Mode).NOTE: Dose Limit periods are specified as 1 and 4 hours on an infuser with the Default Drug Library. Dose Limit periods on infusers with a User-defined Drug Library, may be defined as 1, 4, 6, or 12 hours.
LifeCare PCA Infusion System 5 - 3430-04685-001 (Rev. 7/05)CONTINUOUSA programmed Continuous infusion is started by pressing the [START/PAUSE] Button after the door is closed and locked. The patient pendant is disabled in CONTINUOUS Mode. Upon reaching the DOSE LIMIT, if entered, the infuser stops drug delivery, and the designated HR LIMIT REACHED Message is displayed. NOTE: Dose Limit periods are specified as 1 and 4 hours on an infuser with the Default Drug Library. Dose Limit periods on infusers with a User-defined Drug Library may be defined as 1, 4, 6, or 12 hours.NOTE: In CONTINUOUS or PCA+CONTINUOUS Mode, The [START/PAUSE] Button must be pressed within 30 seconds of locking the door or the infuser sounds an alarm.PCA+CONTINUOUSA programmed PCA+Continuous infusion is started by pressing the [START/PAUSE] Button after the door is closed and locked. A patient initiated PCA dose may be administered using the patient pendant when the PCA AVAILABLE Message appears. When the patient-initiated dose is activated, the PCA dose is delivered prior to the CONTINUOUS infusion rate. After the PCA dose is completed, the infuser enters the LOCKOUT Interval. While in the lockout period, the CONTINUOUS infusion remains in progress, but the patient initiated dose cannot be activated. If a Dose limit has been reached, the infuser stops all drug delivery.NOTE: Dose Limit periods are specified as 1 and 4 hours on an infuser with the Default Drug Library. Dose Limit periods on infusers with a User-defined Drug Library may be defined as 1, 4, 6, or 12 hours.NOTE: In CONTINUOUS or PCA+CONTINUOUS Mode, The [START/PAUSE] Button must be pressed within 30 seconds of locking the door or the infuser sounds an alarm.
5 - 4 Select Mode 430-04685-001 (Rev. 7/05) 5.2 PCA Only ModeFor detailed startup information including vial insertion, clearing settings, purging, and setting a Loading Dose, see Loading a Vial on page 4 - 20.For information on adjusting system settings such as contrast and volume see Adjusting Settings on page 4 - 22.1. Unlock door and press Button, or load drug vial into cradle, to power on the infuser. Upon initial start-up the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.2. Select CONTINUE> to advance to the next programming screen.3. Select YES> or NO> at the NEW PATIENT SCREEN if the infuser has been OFF 4 hours or less. See New Patient on page 4-28 for more information.4. Select CONFIRM> to accept the inserted drug, or remove the vial if it is not correct. See New Patient on page 4-28 for more information.5. Select either YES> or NO> to purge the system.See Purging the System on page 4-29 for more information.6. If YES> is selected, disconnect the set from the patient, and press & hold the PURGE> Softkey.7. Select YES> to continue, or select NO> to purge again until complete.8. Reconnect set to patient. LifeCare PCASELF TEST
LifeCare PCA Infusion System 5 - 5430-04685-001 (Rev. 7/05)9. Set Loading Dose (if desired) by selecting YES>. See Loading Dose on page 4-31 for more information.10. Enter a Loading Dose within the displayed range.11. Then press .Select YES> to infuse the programmed Loading Dose. Select Deliver Later> to delay loading dose delivery. 12. From the Select Delivery Mode SCREEN, select PCA ONLY>.ENTERMORPHINE PF1 mg/mLDELIVERLOADING DOSENOW?YESDELIVER LATER SELECT DELIVERY MODEPCA ONLYPCA + CONT.CONTINUOUSPROTOCOLSPREVIOUSMORPHINE PF1 mg/mL
5 - 6 Select Mode 430-04685-001 (Rev. 7/05) 13. Enter the desired PCA dose using the numeric keypad. If the value is entered incorrectly, press to change value.14. Then press .If programming changes need to be made, select PREVIOUS> to return to the preceding screen.15. Enter a lockout Interval value. (The value range is displayed on the screen.)If the value is entered incorrectly, press to change value.16. Then press .If programming changes need to be made, select PREVIOUS> to return to the preceding screen.17. Set a specific dose limit by selecting YES> and advancing to the Dose Limit Enter Value SCREEN. Or select NO> to choose No Dose Limit.No Dose Limit will be selected for this example.If Hospira MedNetTM Software is enabled and a upper hard or soft limit for that CCA and drug, then a DOSE LIMIT entry is required, and this screen will not be displayed. ENTER PCA DOSE THEN PRESS ENTER BUTTONPREVIOUS2 mgmilligrams0.1 - 5 mgMORPHINE PF1 mg/mLCLRENTER ENTER LOCKOUT INTERVAL THEN PRESS ENTER BUTTON 10 minminutes5-120 minPREVIOUSMORPHINE PF1 mg/mLCLRENTERMORPHINE PF1 mg/mL SET A DOSE LIMIT? YESNOPREVIOUS
LifeCare PCA Infusion System 5 - 7430-04685-001 (Rev. 7/05)NOTE: See Dose Limit on page 5-21 (1 or 4 hour) for complete information about this feature.18. Select CONFIRM> to verify the NO DOSE LIMIT selection.Select PREVIOUS> to return to the preceding screen.19. Select CONFIRM> to verify settings. Or, select PREVIOUS> to return to the preceding screen.20. Close and lock door. Place key in a secure location. After locking the door the PCA bolus is available for infusion. Patient presses pendant to initiate PCA dose. CONFIRM NO DOSE LIMIT? CONFIRMPREVIOUSMORPHINE PF1 mg/mLMORPHINE PF1 mg/mLPCA ONLY LOCKOUT 4 HOUR LIMIT2 mgNO PCA DOSE10 minCONFIRMPREVIOUS
5 - 8 Select Mode 430-04685-001 (Rev. 7/05) Approximately 10 seconds after the door is locked, the DOOR LOCKED Message disappears. After delivering the PCA dose, the PCA LOCKOUT Message appears indicating the PCA Infuser is locked out.If the Patient Pendant is partially pressed, a Pendant Fault Message appears. This is corrected by releasing the button.When the Dose Limit is reached, a message is displayed to indicate the Dose Limit has been reached.NOTE: A clinician may stop a PCA dose delivery in progress without unlocking the door by pressing the [STOP/PAUSE] BUTTON.PCA DOSE =2 mgTOTAL DELIVERED7.5 mgmilligramsPCA LOCKOUTNO 4 HR LIMITMORPHINE PF1 mg/mLPCA ONLY
LifeCare PCA Infusion System 5 - 9430-04685-001 (Rev. 7/05)5.3 Continuous ModeFor detailed startup information including vial insertion, clearing settings, purging, and setting a Loading Dose, see Loading a Vial on page 4 - 20.For information on adjusting system settings such as contrast and volume see Adjusting Settings on page 4 - 22.1. Unlock door and press Button, or load drug vial into cradle, to power on the infuser. Upon initial start-up the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.2. Select CONTINUE> to advance to the next programming screen.3. Select YES> or NO> at the NEW PATIENT SCREEN if the infuser has been OFF 4 hours or less. See New Patient on page 4-28 for more information.4. Select CONFIRM> to accept the inserted drug, or remove the vial if it is not correct. See New Patient on page 4-28 for more information.5. Select either YES> or NO> to purge the system. See Purging the System on page 4-29 for more information.6. If YES> is selected, disconnect the set from the patient, and press & hold the PURGE> Softkey.7. Select YES> to continue, or select NO> to purge again until complete.LifeCare PCASELF TEST
5 - 10 Select Mode 430-04685-001 (Rev. 7/05) 8. After purging, reconnect set to patient. 9. Set Loading Dose (if desired) by selecting YES>. See Loading Dose on page 4-31 for more information.Enter a Loading Dose within the displayed range.10. Then press .Select YES> to infuse the programmed Loading Dose. Select Deliver Later> to delay loading dose delivery. 11. From the Select Delivery Mode SCREEN, select CONTINOUOUS>.ENTERMORPHINE PF1 mg/mLDELIVERLOADING DOSENOW?YESDELIVER LATER SELECT DELIVERY MODEPCA ONLYPCA + CONT.CONTINUOUSPROTOCOLSPREVIOUSMORPHINE PF1 mg/mL
LifeCare PCA Infusion System 5 - 11430-04685-001 (Rev. 7/05)12. Enter a continuous rate using the keypad. The value range is displayed on the screen. If value is entered incorrectly, press to change value.13. Then press .If programming changes need to be made, select PREVIOUS> to return to the preceding screen.14. Set a specific dose limit by selecting YES> and advancing to the Dose Limit Enter Value SCREEN. Select NO> to choose No Dose Limit.No Dose Limit will be selected for this example.If Hospira MedNetTM Software is enabled and a upper hard or soft limit for that CCA and drug, then a DOSE LIMIT entry is required, and this screen will not be displayed.NOTE: The pre-programmed Dose Limit is 1 or 4 hours. The Hospira MedNetTM Software range is larger (1, 4, 6, or 12 hours). For complete information on this feature, see Dose Limit on page 5 - 21. ENTER CONT. RATE THEN PRESS ENTER BUTTONPREVIOUSmilligrams0.5-100 mg/hr2mghrMORPHINE PF1 mg/mLCLRENTER SET A DOSE LIMIT?YESNOPREVIOUSMORPHINE PF1 mg/mL
5 - 12 Select Mode 430-04685-001 (Rev. 7/05) 15. Select CONFIRM> to verify No Dose Limit selection.Select PREVIOUS> to return to the preceding screen.16. Select CONFIRM> to verify settings. Or, select PREVIOUS> to return to the preceding screen.17. Close and lock door. Place key in a secure location. 18. Press to begin therapy. Approximately 10 seconds after door is locked and is pressed, the DOOR LOCKED Message disappears.When the Dose Limit is reached, a message is displayed that indicates the Dose Limit has been reached. CONFIRM NO DOSE LIMIT? PREVIOUSCONFIRMMORPHINE PF1 mg/mLCONFIRMPREVIOUSNOPCONT. RATE4 HOUR LIMITMORPHINE PF1 mg/mLCONTINUOUS2 mg/hrCONT. RATE =2 mg/hrTOTAL DELIVERED2 mgmilligramsMORPHINE PF1 mg/mLCONTINUOUS
LifeCare PCA Infusion System 5 - 13430-04685-001 (Rev. 7/05)5.4 PCA+Continuous ModeFor detailed startup information including vial insertion, clearing settings, purging, and setting a Loading Dose, see Loading a Vial on page 4 - 20.For information on adjusting system settings such as contrast and volume see Adjusting Settings on page 4 - 22.1. Unlock door and press Button, or load drug vial into cradle, to power on the infuser. Upon initial start-up the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.2. Select CONTINUE> to advance to the next programming screen.3. Select YES> or NO> at the NEW PATIENT SCREEN if the infuser has been OFF 4 hours or less. See New Patient on page 4-28 for more information.4. Select CONFIRM> to accept the inserted drug, or remove the vial if it is not correct. See New Patient on page 4-28 for more information.5. Select either YES> or NO> to purge the system.See Purging the System on page 4-29 for more information.6. If YES> is selected, disconnect the set from the patient, and press & hold the PURGE> Softkey.7. Select YES> to continue, or select NO> to purge again until complete.8. Reconnect set to patient. LifeCare PCASELF TEST
5 - 14 Select Mode 430-04685-001 (Rev. 7/05) 9. Set Loading Dose (if desired) by selecting YES>. See Loading Dose on page 4-31 for more information.10. Enter a Loading Dose within the displayed range.11. Then press .12. Select YES> to infuse the programmed Loading Dose. Select Deliver Later> to delay loading dose delivery. 13. From the SELECT MODE SCREEN, select PCA + CONT>.ENTERMORPHINE PF1 mg/mLDELIVERLOADING DOSENOW?YESDELIVER LATER ENTER PCA DOSE THEN PRESS ENTER BUTTONPREVIOUS2 mgmilligrams0.1 - 5 mgMORPHINE PF1 mg/mLMORPHINE PF1 mg/mL SELECT DELIVERY MODEPREVIOUSPCA ONLYPCA + CONT.CONTINUOUSPROTOCOLS
LifeCare PCA Infusion System 5 - 15430-04685-001 (Rev. 7/05)14. Enter PCA dose value using the keypad. The value range is displayed on the screen. If value is entered incorrectly, press to change value.15. Then press .If programming changes need to be made, select PREVIOUS> to return to the preceding screen.16. Enter a Lockout Interval value. (Value range is displayed on thescreen.)If the value is entered incorrectly, press to change the value.17. Then press .If programming changes need to be made, select PREVIOUS> to return to the preceding screen.18. Enter a Continuous Rate. The value range is displayed on screen.If the value is entered incorrectly, press to change the value.19. Then press .MORPHINE PF1 mg/mL ENTER PCA DOSE THEN PRESS ENTER BUTTON0.1-5 mgmilligrams2 mgPREVIOUSCLRENTERMORPHINE PF1 mg/mL ENTER LOCKOUT INTERVAL THEN PRESS ENTER BUTTON5-120 minminutes10 minPREVIOUSCLRENTERMORPHINE PF1 mg/mL ENTER CONT. RATE THEN PRESS ENTER BUTTONPREVIOUS2milligrams0.1-20 mg/hrmghrCLRENTER
5 - 16 Select Mode 430-04685-001 (Rev. 7/05) If programming changes need to be made, select PREVIOUS> to return to the preceding screen.20. Set a specific dose limit by selecting YES> and advancing to the DOSE LIMIT ENTER VALUE SCREEN. Or select NO> to choose NO DOSE LIMIT.Setting a specific Dose Limit will be selected for this example.If Hospira MedNetTM Software is enabled and a upper hard or soft limit for that CCA and drug, then a DOSE LIMIT entry is required, and this screen will not be displayed.NOTE: The pre-programmed Dose Limit is 1 or 4 hours. The Hospira MedNetTM Software range is larger (1, 4, 6, or 12 hours). For complete information on this feature see Dose Limit on page 5 - 21.21. Enter the Dose Limit value using the numeric keypad (the range is displayed on the screen).If the value is entered incorrectly, press to change value.22. Then press .If programming changes need to be made, select PREVIOUS> to return to the preceding screen.MORPHINE PF1 mg/mL SET A DOSE LIMIT? YESNOPREVIOUSMORPHINE PF1 mg/mL ENTER 4 HOURDOSE LIMIT THEN PRESS ENTER BUTTON2-80 mg40 mg milligramsPREVIOUSCLRENTER
LifeCare PCA Infusion System 5 - 17430-04685-001 (Rev. 7/05)23. Select CONFIRM> to verify settings. Or, select PREVIOUS> to return to the preceding screen.24. Close and lock door. Place key in a secure location. After locking the door the PCA bolus is available for infusion. The patient presses pendant to initiate PCA dose.25. Press to begin therapy. Approximately 10 seconds after door is locked and is pressed, the DOOR LOCKED Message disappears.When the Dose Limit is reached, a message is displayed that indicates the Dose Limit has been reached.MORPHINE PF1 mg/mLPCA+CONT LOCKOUT 4 HOUR LIMIT2 mg2 mg/hr40 mg PCA DOSE10 min CONT. RATECONFIRMPREVIOUSCONT. RATE2 mg/hrMORPHINE PF1 mg/mLTOTAL DELIVERED2 mgmilligramsPCA AVAILABLEPCA+CONT.
5 - 18 Select Mode 430-04685-001 (Rev. 7/05) 5.5 ProtocolsFor detailed startup information including vial insertion, clearing settings, purging, and setting a Loading Dose, see Loading a Vial on page 4 - 20.For information on adjusting system settings such as contrast and volume see Adjusting Settings on page 4 - 22.NOTE: Protocols may be established by the hospital via Hospira MedNetTM Software or via Biomed Mode. Hospira MedNetTM Software enabled devices allow for protocol programming from the Rx Rules application. Only Protocols associated with the inserted drug vial will be available.1. Unlock door and press Button, or load drug vial into cradle, to power on the infuser. Upon initial start-up, the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.2. Select CONTINUE> to advance to the next programming screen.3. Select YES> or NO> at the NEW PATIENT SCREEN if the infuser has been OFF 4 hours or less. For more information see New Patient on page 4 - 28.4. Select CONFIRM> to accept the inserted drug, or remove the vial if it is not correct. See New Patient on page 4-28 for more information.5. Select either YES> or NO> to purge the system. For more information see Purging the System on page 4 - 29.LIFECARE PCASELF TEST
LifeCare PCA Infusion System 5 - 19430-04685-001 (Rev. 7/05)6. If YES> is selected, disconnect the set from the patient, and press and hold the PURGE>.7. Select YES> to continue, or select NO> to purge again until complete.8. After purging, reconnect set to patient. 9. Set Loading Dose (if desired) by selecting YES>. For more information see Loading Dose on page 4 - 31.10. Enter a Loading Dose in the displayed range.11. Then press .12. Press to infuse programmed Loading Dose. Select DELIVER LATER> to delay loading dose delivery. From the SELECT DELIVERY MODE SCREEN, select PROTOCOLS>.13. Press to accept protocol, or select NEXT PROTOCOL> and PREVIOUS> to view other stored protocols if available.ENTERMORPHINE PF1 mg/mL SELECT DELIVERY MODEPREVIOUSPCA ONLYPCA + CONT.CONTINUOUSPROTOCOLS LOCKOUT 4 HOUR LIMIT2 mgNONE PCA DOSE10 minNEXT PROTOCOLPREVIOUSMORPHINE PFPRESS ENTERTO SELECT #3ENTER
5 - 20 Select Mode 430-04685-001 (Rev. 7/05) 14. Select CONFIRM> to accept the chosen protocol settings. Or press PREVIOUS> to return to the preceding screen.15. Close and the lock door. Place key in a secure location.16. Press to begin therapy. Approximately 10 seconds after door is locked and is pressed, the DOOR LOCKED MESSAGE disappears.MORPHINE PF1 mg/mLPCA+CONT LOCKOUT 4 HOUR LIMIT2 mg2 mg/hr40 mg PCA DOSE10 min CONT. RATECONFIRMPREVIOUS
LifeCare PCA Infusion System 5 - 21430-04685-001 (Rev. 7/05)5.6 Dose LimitThe dose limit is a physician prescribed value that serves to limit the total dosage delivered in any 4 hour (or 1 hour) period. This optional feature provides added safety that limits the total drug delivered in all delivery modes.NOTE: Dose limit periods are specified as 1 and 4 hours on a infuser using the Default Drug Library (DDL); on infusers using User-Defined Drug Libraries created with the Hospira MedNetTM Software, the dose limit periods are 1, 4, 6, or 12 hours. There is a NO Dose Limit option as well with DDL and User Defined Drug Library. The PCA Infuser is factory set to program a 4 hour dose limit. For the purpose of simplifying this section, examples will be written for a 4 hour dose limit program.NOTE: A supplemental Loading Dose may be delivered at any time during operation by opening the door and selecting the LOADING DOSE> key. When the sum of all doses (PCA dose, CONTINUOUS dose, and any applicable loading or supplemental loading dose) in a rolling 4 hour period equals or exceeds the 4 hour dose limit, the patient’s requests for PCA doses are denied, and a 4 HR LIMIT REACHED Message appears. In all modes, the infuser stops delivery when the 4 hour dose limit is reached, except during administration and delivery of a supplemental loading dose.As the oldest dose (either PCA dose, CONTINUOUS dose, or a supplemental loading dose) ages out of the 4 hour dose record, the 4 HR LIMIT REACHED Message disappears. The infuser accepts patient initiated dose requests in PCA Only and PCA+CONTINUOUS Modes (if the programmed PCA Lockout Interval has elapsed) and resumes infusion at the continuous rate in the CONTINUOUS and PCA+CONTINUOUS Modes.NOTE: Setting a new dose limit will not erase the previous dose history.
5 - 22 Select Mode 430-04685-001 (Rev. 7/05) PROGRAMMING THE 4 (OR 1) HOUR DOSE LIMITThe opportunity to program this feature is presented in two entry screens. The first screen prompts the clinician to choose whether or not to set a Dose Limit. Selecting NO> brings up the CONFIRM NO DOSE LIMIT SCREEN. Selecting YES> brings up the DOSE LIMIT ENTER VALUE SCREEN. This requires that the clinician enter a value within the displayed range.NOTE: If Hospira MedNetTM Software is enabled, and a upper hard or soft limit for that CCA and drug has been assigned, then a DOSE LIMIT entry is required.PROGRAMMING A DOSE LIMIT1. Select YES> at the DOSE LIMIT SELECTION SCREEN.The display advances to the DOSE LIMIT ENTER VALUE SCREEN.2. Enter the 4 HOUR DOSE LIMIT value using the numeric keypad.NOTE: Entry of zero for the 4 HR Dose Limit, using the numeric keypad, is NOT accepted by the PCA Infuser; see Programming No Dose Limit on page 5 - 24.3. Then press .MORPHINE PF1 mg/mL SET A DOSE LIMIT? YESNOPREVIOUSMORPHINE PF1 mg/mL ENTER 4 HOURDOSE LIMIT THEN PRESS ENTER BUTTON.1-80 mg40 mg milligramsPREVIOUSENTER
LifeCare PCA Infusion System 5 - 23430-04685-001 (Rev. 7/05)4. Select CONFIRM> to accept the chosen protocol settings. Or press PREVIOUS> to return to the preceding screen.5. Close and lock the door. Place key in a secure location.6. Press to begin therapy. Approximately 10 seconds after door is locked and is pressed, the DOOR LOCKED MESSAGE disappears.MORPHINE PF1 mg/mLPCA+CONT LOCKOUT 4 HOUR LIMIT2 mg2 mg/hr40 mg PCA DOSE10 min CONT. RATECONFIRMPREVIOUS
5 - 24 Select Mode 430-04685-001 (Rev. 7/05) PROGRAMMING NO DOSE LIMIT1. Select NO> at the DOSE LIMIT SELECTION SCREEN.The display advances to the Confirm NO DOSE LIMIT SCREEN.2. Select CONFIRM> to verify the selection of the No Dose limit.NOTE: When NO LIMIT has been programmed, the message NO 4 HR LIMIT will be displayed after the door has been locked.3. Select CONFIRM> to accept the chosen protocol settings. Or press PREVIOUS> to return to the preceding screen.4. Close and the lock door. Place key in a secure location.5. Press to begin therapy. Approximately 10 seconds after door is locked and is pressed, the DOOR LOCKED MESSAGE disappears.MORPHINE PF1 mg/mL SET A DOSE LIMIT? YESNOPREVIOUSMORPHINE PF1 mg/mL CONFIRM NO DOSE LIMIT? CONFIRMPREVIOUSMORPHINE PF1 mg/mLPCA+CONT LOCKOUT 4 HOUR LIMIT2 mg2 mg/hr40 mg PCA DOSE10 min CONT. RATECONFIRMPREVIOUS
LifeCare PCA Infusion System 5 - 25430-04685-001 (Rev. 7/05)CLEARING OR CHANGING A DOSE LIMIT1. Unlock door to stop the infuser. 2. Select CHANGE RX>.NOTE: CHANGE CCA> will only display if Hospira MedNetTM Software has been enabled.3. Select NEXT> to display more change options.MORPHINE PF1 mg/mLPAUSEDPCA+CONT LOCK DOOR TO BEGINLOADING DOSECHANGE RXCLEAR SHIFTCHANGE CCAMORPHINE PF1 mg/mL SELECT SETTING TO CHANGEMODEPCA DOSECONT. RATENEXTSAVE & EXIT
5 - 26 Select Mode 430-04685-001 (Rev. 7/05) 4. Select DOSE LIMIT>.5. Set a specific dose limit by selecting YES> then advance to the DOSE LIMIT ENTER VALUE SCREEN.Or, select NO> to choose NO DOSE LIMIT.No Dose Limit will be selected for this example.6. Select CONFIRM> to verify the NO DOSE LIMIT selection. Or, select PREVIOUS> to return to the preceding screen.MORPHINE PF1 mg/mL SELECT SETTING TO CHANGELOCKOUTDOSE LIMITSAVE & EXITNEXTMORPHINE PF1 mg/mL SET A DOSE LIMIT? YESNOPREVIOUSMORPHINE PF1 mg/mL CONFIRM NO DOSE LIMIT? CONFIRMPREVIOUS
LifeCare PCA Infusion System 5 - 27430-04685-001 (Rev. 7/05)7. Press SAVE & EXIT> at the next screen. This will bring up the REVIEW/CONFIRMATION SCREEN.8. Press CONFIRM> to accept a new program.MORPHINE PF1 mg/mL SELECT SETTING TO CHANGELOCKOUTDOSE LIMITSAVE & EXITNEXTMORPHINEPF1 mg/mLPCA ONLY PCA DOSE 2 mg LOCKOUT 10 min 4HOUR LIMITCONFIRMPREVIOUSNO
5 - 28 Select Mode 430-04685-001 (Rev. 7/05) 5.7 Clearing the History and/or Rx Settings1. To clear the HISTORY AND RX settings turn the infuser [OFF] and [ON] again to get to the NEW PATIENT Screen.2. Press Yes> and HISTORY AND RX settings are cleared.NOTE: The NEW PATIENT SCREEN appears if the infuser has been off for 4 hours or less. HISTORY AND RX are automatically cleared and the NEW PATIENT SCREEN is not displayed.3. Select CONFIRM> to accept the inserted drug, or remove the vial if it is not correct. New Patient?YesNoMORPHINE PF1 mg/mL CONFIRM 1 mg/mL MO RPH INE PF TO RX REMOVE VIAL IF NOT CORRECTCONFIRM
LifeCare PCA Infusion System 5 - 29430-04685-001 (Rev. 7/05)5.8 Using Review/Confirmation ScreensPrior to locking the infuser and removing the key, a REVIEW/CONFIRMATION SCREEN appears as shown below. As determined by the programmed mode of delivery, the screen displays the current settings for the applicable parameters (including PCA Dose, Lockout Interval, Continuous Rate, and Dose Limit).•Clinicians should review each pro-grammed parameter and ensure that the displayed program agrees with the physician’s order.•If all of the programmed parameters AGREE with the physician’s order, the clinician accepts the settings by selecting CONFIRM>.•If one or more of the programmed parameters do not agree with the physician’s order, the clinician should select PREVIOUS> until the incorrectly programmed parameter(s) is displayed. Depending on the incorrect parameter(s), the programmed values may be changed by either entering the new value by using the numeric key-pad and pressing [ENTER] or selecting the new setting using the appropriate SOFTKEY>. Once the appropriate parameters have been changed, the REVIEW/CONFIRMATION SCREEN will be presented again. The clinician should review each setting to ensure agreement with the physician’s order.•Once CONFIRM> has been selected, the clinician should close and lock the door.•Place the key in a secure location.•Upon locking the door, the PCA Infuser is available if the mode is set on PCA ONLY. If mode is set for PCA + CONTINUOUS or CONTIN-UOUS, therapy will begin after pressing [START/PAUSE].MORPHINE PF1 mg/mLPCA+CONT LOCKOUT 4 HOUR LIMIT2 mg2 mg/hr40 mg PCA DOSE10 min CONT. RATECONFIRMPREVIOUS
5 - 30 Select Mode 430-04685-001 (Rev. 7/05) 5.9 Changing Settings During SetupDuring setup, select PREVIOUS> to return to the preceding display and enter the desired setting. Each time PREVIOUS> is selected, the message display reverts to the previous setting, until the first setting is displayed.STOPPING INFUSION1. Close slide clamp on the PCA Infuser administration set.WARNINGAlways close slide clamp on the PCA administrationset before removing or replacing the syringe, andbefore discontinuing infusion.2. Unlock door.3. Or, press for Continuous or PCA + Continuous.NOTE: If paused longer than two minutes without pressing an appropriate key, the infuser alarm will sound.TURNING THE INFUSER OFF1. Close slide clamp on PCA administration set.2. Unlock door.3. Press Button
LifeCare PCA Infusion System 5 - 31430-04685-001 (Rev. 7/05)5.10 Making Changes After SetupREVIEWING THE CURRENT SETTINGSSettings may be reviewed while the infuser is running or stopped.1. Press HISTORY Button twice.2. Press to return to main menu.Or, select PREVIOUS> to return to the preceding display.CHANGING SETTINGS1. Unlock the door while the infuser is running. The infuser will be paused.2. Select CHANGE RX> to change individual settings.NOTE: CHANGE CCA> only displays if Hospira MedNetTM Software has been enabled.3. Select the desired field to change (EXAMPLE PCA DOSE>).Or, select NEXT> to display more change options, such as Lockout and Dose Limit. NOTE: If the mode of delivery is changed, the display prompt for reprograming uses the same steps outlined in the beginning of this section.The value previously set for the PCA dose will flash.EXITMORPHINE PF1 mg/mLPAUSEDPCA+CONT LOCK DOOR TO BEGINLOADING DOSECHANGE RXCLEAR SHIFTCHANGE CCAMORPHINEPF1 mg/mL SELECT SETTING TO CHANGEMODEPCA DOSECONT. RATENEXTSAVE & EXIT
5 - 32 Select Mode 430-04685-001 (Rev. 7/05) 4. Enter the desired PCA dose using the numeric keypad. (The value range is displayed on the screen.) If the value is entered incorrectly, press to change value.5. Then press .If programming changes need to be made, select PREVIOUS> to return to the preceding screen.6. If no settings require change, confirm by selecting SAVE AND EXIT>.7. Select CONFIRM> to accept the new program.MORPHINE PF1 mg/mL ENTER PCA DOSE THEN PRESS ENTER BUTTONPREVIOUS1 mgmilligrams0.1 - 5 mgCLRENTERMORPHINE1 mg/mL SELECT SETTING TO CHANGEMODEPCA DOSECONT. RATESAVE & EXITMORPHINE PF1 mg/mLPCA ONLY PCA DOSE 1 mg LOCKOUT 10 min 4HOUR LIMITCONFIRMPREVIOUSNO
LifeCare PCA Infusion System 5 - 33430-04685-001 (Rev. 7/05)CHANGING THE CCA1. Unlock the door while the infuser is running. The infuser will pause.2. Select CHANGE CCA> to change the setting.NOTE: CHANGE CCA> will only display if Hospira MedNetTM Software has been enabled.WARNINGChanging the CCA clears the RX settings.3. At the WARNING SCREEN select CONTINUE>.4. Select new CCA. MORPHINE PF1 mg/mLCARDIOLOGYPAUSEDPCA+CONT LOCK DOOR TO BEGINLOADING DOSECHANGE RXCLEAR SHIFTCHANGE CCAWARNING!CHANGING CCAWILL CLEAR THE RX SETTINGSMORPHINE PF1 mg/mLCARDIOLOGYPREVIOUSCONTINUEPACUMEDSURGPEDIATRICSERNEXTSELECT CCA
5 - 34 Select Mode 430-04685-001 (Rev. 7/05) 5.11 Clearing Shift Totals1. Review & record shift totals using the HISTORY BUTTON before clearing the shift totals.2. Unlock the door while the infuser is running. The infuser will be paused.3. Select CLEAR SHIFT> to display theoption to clear the total dose delivered.NOTE: CHANGE CCA> will only display if Hospira MedNetTM Software was enabled.4. Select YES> to clear shift totals and return to the previous screen.NOTE: Selecting YES> clears the PCA Summary data and total dose delivered, but does not clear dose limit data.5. Or, select NO> to return to previous screen.6. Close and the lock door. Place key in a secure location.7. Press to begin therapy. Approximately 10 seconds after door is locked and is pressed, the DOOR LOCKED MESSAGE disappears.MORPHINE PF1 mg/mLPAUSEDPCA+CONT LOCK DOOR TO BEGINLOADING DOSECHANGE RXCLEAR SHIFTCHANGE CCAMORPHINE PF1 mg/mL CLEAR SHIFT TOTALS?YESNO
LifeCare PCA Infusion System 5 - 35430-04685-001 (Rev. 7/05)5.12 Changing a Vial1. The alarm message EMPTY SYRINGE appears along with the statement REPLACE SYRINGE.2. Close the slide clamp on the PCA administration set.NOTE: The screen displays that the infuser is PAUSED.3. Remove the old vial by firmly grasping the glass vial on both sides and pulling straight out.4. Load the new vial as shown before.(See Loading a Vial on page 4 - 20.)If a change is detected from the previous vial or infused drug, the WARNING! DRUG AND/OR CONCENTRATION CHANGE DETECTED SCREEN appears.5. Verify vial and Rx. If vial and Rx is as intended, select CONTINUE>. Available selections depend on the previous vial drug and concentration in the infuser verses the new vial.6. Select YES> when Purge is displayed.WARNINGDisconnect the patient from the PCA set before thepurge cycle.7. At this point:a. Disconnect the set from the patient.b. Release the slide clamp on the PCA administration set.MORPHINE PF1 mg/mLWARNING!INCORRECTCONCENTRATIONCHANGEDETECTED!CONTINUE ORREMOVE VIAL IFCONTINUE
5 - 36 Select Mode 430-04685-001 (Rev. 7/05) c. Select & hold the PURGE> key until fluid is seen at the end of the set and no air remains inside the set.NOTE: Purging is recommended to remove slack when a new vial is inserted. The system must be primed before purging. The maximum volume delivered during a purge is 3 mL.NOTE: The drug delivered during the purge cycle is NOT stored in system memory and will not be displayed.CAUTION: In CONTINUOUS and PCA+CONTINUOUSModes, if a purge is not performed after a syringechange, the infuser automatically performs a smallsystem compliance step to remove slack when [START]is pressed (with doors locked). Although fluid is notnormally delivered to the patient during thecompliance step, it is recommended that the set bedisconnected from the patient during this operation.8. Upon release of the PURGE> Softkey, the prompt asks if the purge is complete.a. Select YES> to continue, or select NO> to purge again un complete.b. Reconnect the set to the patient.c. The CONFIRMATION Screen appears.d. Review the entered parameters, and if they are correct, select CONFIRM>.9. Close and lock the door to begin infusion. Press the BUTTON if the infuser is in the Continuous or PCA + Continuous Mode.
LifeCare PCA Infusion System 5 - 37430-04685-001 (Rev. 7/05)5.13 Adding a Supplemental Loading Dose1. Unlock the door the infuser will pause.2. Select LOADING DOSE>.NOTE: CHANGE CCA> will only display if Hospira MedNetTM Software has been enabled.3. Enter a Loading Dose within the displayed range.4. Then press .5. Press to infuse the loading dose.NOTE: The loading dose may be halted at any time by pressing [START/PAUSE].6. Close and lock the door. MORPHINE PF1 mg/mLPAUSEDPCA+CONT LOCK DOOR TO BEGINLOADING DOSECHANGE RXCLEAR SHIFTCHANGE CCAMORPHINE PF1 mg/mL ENTER LOADING DOSE THEN PRESS ENTER BUTTON0.1 - 10 mgmilligramsPREVIOUS2.5 mgENTERMORPHINE PF1 mg/mLPREVIOUS PRESS START BUTTON TO INFUSE 2.5 mg LOADING DOSE
5 - 38 Select Mode 430-04685-001 (Rev. 7/05) 5.14 Checking History & SettingsNOTE: Program may be reviewed at any time by pressing the HISTORY BUTTON .1. To Check History or settings, press BUTTON at any time.2. Press or BUTTON to scroll through history. Or select PRINT HISTORY> to print (if connected to printer). The Print History option does not appear when Hospira MedNetTM Software is enabled.3. Press or BUTTON a second time for more information.When MORE is displayed, more information is stored in infuser history.NOTE: Partial boluses can be the result of interrupting delivery by pressing [START/STOP] (PCA + Count.), opening the door (PCA Only), loss of power, reaching the dose limit, emptying the vial, or a malfunction alarm. PRESS HISTORY OR ENTER BUTTON TO SCROLL THROUGH HISTORYPRINT HISTORYENTERMORPHINE PF1 mg/mLPCA+CONTPCA DOSE 0.5 mgLOCKOUT 5 minCONT. RATE10 mg/hr4 HOUR LIMIT NOMORE...PREVIOUSENTER
LifeCare PCA Infusion System 5 - 39430-04685-001 (Rev. 7/05)4. Continue to press or BUTTON for more information such as:•Last one hour information if configured•Last 24-Hour information if configured•Current settings•Total drug delivered toward the dose limit•Event LogThe Event Log shows all events since the last Clear History. Up to 400 events are shown.5. Press to return to the MAIN DELIVERY SCREEN.6. Close and lock door. Press [START/PAUSE] if in Continuous or PCA+Continous mode.PREVIOUSTIME : 8:04 PMDATE : 01/15/01S/N:12920191DELIVERED: 4 HOUR DOSE LOADING DOSE2 mg2 mg2 mg TOTAL DEL.MORE...ENTEREXIT
5 - 40 Select Mode 430-04685-001 (Rev. 7/05) 5.15 History and Event LogThe infuser stores data on therapy settings, quantity and/or number of doses delivered, and has the capacity of recording up to 20,000 events. The PCA Infuser displays a chronological record of 400 of the most recent events occurring during infusion by pressing the [HISTORY] Button. These events include: PCA doses requested, the amount delivered, the change of any settings, the opening or closing of the security door, start or stop of continuous infusion, and alarm conditions (For more information see Data Retention on page 4 - 16). Pressing the [HISTORY] Button displays this data on the LCD. Pressing PRINT HISTORY> generates a hard copy printout of the data. When the infuser is configured with the HOUR-BY-HOUR history format, the number of PCA injections, partial doses, and patient demands occurring in each one-hour period during the last 24 hours may be displayed or printed. Only the one-hour periods with PCA activity are displayed and printed. When the infuser is configured for the LAST 1 & 24 HOUR history format, PCA activity totals in the last hour and in the last 24 hours are displayed and printed.Note: The HOUR-BY-HOUR and the LAST 1 & 24 HOUR history totals represent a dynamic summation of past delivery of drugs and events. Data is accumulated in 10 minute time slots. At any given time, the last 10 minute time slot may represent anywhere from 0 to 10 minutes of data. The hour and 24-hour periods are approximate only and may, in fact, represent as small as 50 minutes of data for the LAST HOUR total and 23 hours 50 minutes for the LAST 24 HOUR total.Note: PCA requested doses (patient demands) as recorded in the history display and event log may not reflect the total number of demands. (Maximum of 100 patient demands per 10 minute interval.)
LifeCare PCA Infusion System 5 - 41430-04685-001 (Rev. 7/05)Note: Events occurring while printing is in progress are stored in memory, but not included in the current printout.Note: If the lithium battery, the micro-controller unit, or the electronics assembly have been replaced, the serial number will NOT display on printouts.See the following pages for a sample history printout (in the PCA+CONTINUOUS Mode).
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LifeCare PCA Infusion System 5 - 43430-04685-001 (Rev. 7/05)
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5 - 46 Select Mode 430-04685-001 (Rev. 7/05)
LifeCare PCA Infusion System 6 - 1430-04685-001 (Rev. 7/05)Section 6Advanced Programming with Hospira MedNetTM SoftwareThe following topics are addressed in this section:•Guided Start-up Using Hospira MedNet TM Software •Select CCA •Soft Limit Override •Hard Limit Violation •Important Symbols •Autoprogramming
6 - 2 Advanced Programming with Hospira MedNetTMSoftware430-04685-001 (Rev. 7/05) 6.1 Guided Start-up Using Hospira MedNet TM SoftwareUser Defined Drug Libraries are developed by hospital personnel in conjunction with the pharmacy using Hospira MedNetTM Software.User Defined Drug Libraries allow hospitals to customize drugs in the library with preselected upper and lower delivery limits to ensure patient safety.Hospira/Abbott prefilled bar coded PCA Vials and custom vials (with pharmacy-generated bar codes) may be used with the Hospira MedNetTM Software. For instructions on how to produce pharmacy-generated bar codes see Appendix A on page A- 1.1. Press BUTTON, or load drug vial into cradle to power infuser [ON]. See Loading a Vial on page 4- 21. Upon initial start-up, the self-test begins. It may take several seconds for the Hospira logo to appear on the screen.This screen is followed by another screen displaying self-test information that includes the following: time, date, software version and copyright data. During the self-test, the infuser reads the bar code label.LifeCare PCASELF TEST
LifeCare PCA Infusion System 6 - 3430-04685-001 (Rev. 7/05)2. Select CONTINUE> to advance to the next screen.3. The NEW PATIENT SCREEN appears if the infuser has been off for 4 hours or less. Select YES> or NO>.4. If NO> is selected, the History and Rx settings are kept. If YES> is selected, the History and Rx settings are cleared.5. Select CONFIRM> to accept the inserted drug, or remove the vial if it is not correct.LifeCare PCASELF TESTCOMPLETERAM . . . . . OKFLASH . . . OKCPU ID . . . OKCPU . . . . . OKTIMER . . . .OKSYSTEMSETTINGSCONTINUENew Patient?YesNoMORPHINE PF1 mg/mL CONFIRM 1 mg/mL M OR PH IN E P F TO RX REMOVE VIAL IF NOT CORRECTCONFIRM
6 - 4 Advanced Programming with Hospira MedNetTMSoftware430-04685-001 (Rev. 7/05) 6. Select the softkey next to the desired CCA. (example PACU)If only one CCA has been created, that CCA becomes the default CCA, and this screen is skipped.If the desired CCA is not displayed, select NEXT> to view more options.7. Select either YES> or NO> to purge the system.See Purging the System on page 4- 30 for more information.8. If YES> is selected, disconnect the set from the patient, and press and hold the PURGE> Softkey.While purging is occurring, the word PURGING is displayed.NOTE: Purging is recommended to remove system slack when a new vial is inserted. The maximum volume delivered during a purge is 3mL.SELECT CCAPACUONCOLOGYERPEDIATRICNEXTMORPHINE PF1 mg/mL PURGE? PURGING RECOMENDEDYESNOMORPHINE PF1 mg/mL DISCONNECT SET FROM PATIENT PRESS AND HOLD PURGE KEYPURGEPREVIOUS
LifeCare PCA Infusion System 6 - 5430-04685-001 (Rev. 7/05)Upon release of the PURGE> Softkey, the display asks if the purge is complete.9. Select YES> to continue, or select NO> to purge again until complete.10. After purging is complete, reconnect set to patient. 11. Set Loading Dose (if desired) by selecting YES>. See Loading Dose on page 4- 32 for more information.Enter a Loading Dose within the displayed range.12. Then press . PURGE COMPLETE?MORPHINE PF1 mg/mLYESNO SET LOADING DOSE?YESNOMORPHINE PF1 mg/mLPACUMORPHINE PF1 mg/mLPACU ENTER LOADING DOSE THEN PRESS ENTER BUTTON 2 mgmilligramsPREVIOUSENTER
6 - 6 Advanced Programming with Hospira MedNetTMSoftware430-04685-001 (Rev. 7/05) 13. The DELIVER LOADING DOSE NOW SCREEN allows the option of delivering the loading dose now or after the programming is complete.14. If YES> was selected, press to infuse the programmed Loading Dose.NOTE: The LOADING DOSE Mode is the only mode that the infuser will deliver with the door unlocked.WARNINGAlways monitor the infuser when delivering medicationwith the door unlocked.15. If the DELIVER LATER option is desired, the screen advances to the SELECT DELIVERY MODE SCREEN. See Modes of Delivery on page 5- 2 for more information.  DELIVER LOADING DOSE NOW?YESDELIVER LATERMORPHINE PF1 mg/mLPACUMORPHINE PF1 mg/mLPACU PRESS START BUTTON TO INFUSE 2 mg LOADING DOSEPREVIOUS
LifeCare PCA Infusion System 6 - 7430-04685-001 (Rev. 7/05)16. The screen displays the amount of analgesic delivered as it infuses. The bottom of the screen displays text confirming that the Loading Dose is being delivered. Upon completion, the red LED (above the LCD) displays the amount delivered.17. The SELECT MODE SCREEN appears. See Modes of Delivery on page 5- 2 for more information.MORPHINE PF1 mg/mLPACU PRESS PAUSE BUTTON TO STOP2 mgmilligramsINFUSING LOADING DOSEMORPHINE PF1 mg/mLPACU SELECT DELIVERY MODEPCA ONLYPCA + CONT.CONTINUOUSPROTOCOLSPREVIOUS
6 - 8 Advanced Programming with Hospira MedNetTMSoftware430-04685-001 (Rev. 7/05) 6.2 Select CCAThe SELECT CCA SCREEN displays if a user-defined drug library is installed with more than one CCA. Select the option appropriate for the patient.If there is only one CCA, this screen will not display.NOTE: The prior CCA flashes.NOTE: If the wrong CCA is unintentionally chosen, turn the Infuser off, then on, and select the correct CCA.NOTE: When using the Protocol feature be aware that the Protocol numbers are unique to each Clinical Care Area. For example, the protocol for Morphine PF 1mg/mL concentration for PCA + Cont. delivery with a PCA dose of 1mg and continuous rate of 0.5mg may be assigned protocol No. 1 in the Surgical CCA and No. 6 in the Medical CCA. SELECT CCAPACUMEDSURGPEDIATRICSERNEXT
LifeCare PCA Infusion System 6 - 9430-04685-001 (Rev. 7/05)6.3 Updating the Drug LibraryWhen the user presses OFF to shut the Infuser down, if a new user-defined drug library is available for installation the infuser will display the NEW DRUG LIBRARY AVAILABLE SCREEN. Select [No] to skip the installation and continue using the current library. The infuser will power off.orSelect [Yes] to begin the installing the new drug library.The Drug Library Installation Screen will flash the words In Progress on the screen. CAUTION: When a new drug library is installing, ensurethe AC power cord is plugged in until the process iscomplete.YESNO INSTALL NOW?NEW DRUGLIBRARYAVAILABLEDRUGLIBRARYINSTALLIN PROGRESS
6 - 10 Advanced Programming with Hospira MedNetTMSoftware430-04685-001 (Rev. 7/05) The infuser displays the DRUG LIBRARY INSTALL SUCCESSFUL SCREEN after the libray has been installed successfully. The infuser will power off automatically. If the Drug Library is not installed within 15 minutes or if it fails to install, the Infuser displays the UNABLE TO INSTALL DRUG LIBRARY SCREEN, and the infuser will power off automatically. The previous library will be active when the infuser is re-started. DRUGLIBRARYINSTALLSUCCESSFULSHUTTINGDOWNDRUG LIBRARYINSTALLUNABLE TOSHUTTINGDOWN
LifeCare PCA Infusion System 6 - 11430-04685-001 (Rev. 7/05)6.4 Soft Limit OverrideWhen entering parameters, if a soft limit is exceeded, a soft limit override screen is displayed.1. Review display for the exceeded parameter.2. Select CONFIRM> to override the programmed soft limit, or select change to correct the parameter.All soft limit overrides made during programming are indicated on the INFUSION SCREEN with an appropriate upper or lower limit arrow. See Important Symbols on page 6- 12 for details.6.5 Hard Limit ViolationWhen entering parameters, if a hard limit is exceeded, a HARD LIMIT VIOLATION SCREEN is displayed. Hard limits cannot be overridden. The only way to continue is to select CHANGE> to change the parameter.MORPHINE PF1 mg/mL6 mgIS OVER5 mgLIMIT CONFIRMOVERIDESCHANGECONFIRM PCA DOSEMORPHINE PF1 mg/mLALLOWED FOR CHANGE PCA DOSEPACUMED AND CCA8 mgMAX ALLOWED =NOT
6 - 12 Advanced Programming with Hospira MedNetTMSoftware430-04685-001 (Rev. 7/05) 6.6 Important SymbolsNO RULE SETSThe Cautionary Symbol is dis-played on the infusion screen to advise the user to program with caution because the established rule set does not have any soft or hard safety limits.SOFT LIMIT OVERRIDEThe upper and lower Soft Limit Override symbols are displayed on the infusion screen to inform the user that one or more soft limits have been overridden. 11
LifeCare PCA Infusion System 6 - 13430-04685-001 (Rev. 7/05)WIRELESS The Wireless symbol is displayed to inform the user that the PCA Infuser has an active connection to the wireless network.The wireless icon is only displayed on the Waiting for Autoprogram SCREEN. This symbol indicates that the PCA Infuser is connected to the wireless network. It does not indicate if data is currently being sent or received. The Waiting for Autoprogram Message will flash on the screen. PROGRAMPACUMANUALWAITING FORAUTO PROGRAM
6 - 14 Advanced Programming with Hospira MedNetTMSoftware430-04685-001 (Rev. 7/05) 6.7 AutoprogrammingAutoprogramming is a new feature for Hospira PCA infusion pumps. It can only be used if the feature has been installed in conjunction with your Hospital Information System (HIS) and Bar code Point-of-Care (BPOC) Unit. It works by scanning bar code labels for the patient and infuser using a BPOC hand-held unit. This information is then transferred to the infuser utilizing either its wireless antenna or RJ-45 Ethernet connector. The feature reduces the number of steps needed to program an infusion.NOTE: If the physician’s order for an autoprogram therapy exceeds the capabilities of the pump, or is above a hospital defined hard drug limit, the infusion parameters for autoprogramming will be rejected, and the order needs to be rechecked. The pump allows the clinician to change soft limits by changing the value when the SOFT LIMIT VIOLATION SCREEN appears.1. Power On the pump by pressing ON/OFF.2. After the CCA has been selected, the pump is ready for autoprogramming.3. Scan the patient wristband to pull up the patient’s task list on the BPOC hand-held unit.4. Choose the IV task as displayed on the BPOC unit.NOTE: If the scanned medication does not exist in the Hospira MedNetTM Software, Rx Rules medication library, an invalid barcode alarm will be activated. The programming screen is auto-filled. 5. Verify ALL parameters. If changes are desired, select CHG SETTINGS>. Otherwise, if the Rx settings are correct, select CONFIRM>.
LifeCare PCA Infusion System 6 - 15430-04685-001 (Rev. 7/05)6. Verify that the Loading Dose setting is correct. To change the Loading Dose value, select CHG SETTINGS>. Otherwise, if the Loading Dose value is correct, select CONFIRM>.7. To deliver Loading Dose and begin the program, select YES> on the LOADING DOSE NOT GIVEN SCREEN. To cancel the Loading Dose and just start the program, select CANCEL>.8. Close and lock the door. Press [START] to begin program.
6 - 16 Advanced Programming with Hospira MedNetTMSoftware430-04685-001 (Rev. 7/05)
LifeCare PCA Infusion System 7 - 1430-04685-001 (Rev. 7/05)Section 7 TroubleshootingThe PCA Infuser is programmed to display status and alarm messages and to sound an audible tone for most alarm conditions. These messages and alarm conditions are described in the following sections:•Status Messages •Infuser Alarm System •Silencing an Alarm •Alarms and Messages •Infuser Stalling
7 - 2 Troubleshooting430-04685-001 (Rev. 7/05) 7.1 Status MessagesDisplayed status messages are defined in the following table:MESSAGE DEFINITIONDOOR LOCKEDMessage indicates the security door is closed and locked. It displays for 10 seconds and disappears.PCA LOCKOUTMessage appears only in the PCA or PCA+CONTINUOUS Mode. The message remains until the lockout interval elapses and is displayed after a successful patient-originated dose delivery.4 (1) HR LIMIT REACHEDMessage displayed if 4 (or 1) hour dose limit has been selected and reached with security door locked without Hospira MedNetTM Software enabled. Message displayed if 1, 4, 6, 8, 12, hour dose limit has been selected and reached with security door locked with Hospira MedNetTM Software enabled.PCA AVAILABLEMessage indicates patient can initiate a dose in PCA or PCA+CONTINUOUS Mode.PCA Message displayed when infuser is in PCA Mode.CONTINUOUS Message displayed when infuser is in CONTINUOUS Mode.
LifeCare PCA Infusion System 7 - 3430-04685-001 (Rev. 7/05)PCA+CONT. Message displayed when infuser is in PCA+CONTINUOUS Mode.PAUSED Message displayed when infuser is stopped, but door is locked. Or, if door is opened.MESSAGE DEFINITION
7 - 4 Troubleshooting430-04685-001 (Rev. 7/05) 7.2 Infuser Alarm SystemDuring an Alarm condition, the system performs the following actions:•The current display message is saved to the event log.•A flashing alarm message appears on the display (See Alarms and Messages on page 7-6).•A repetitive, audible tone sounds with all MALFUNCTION alarms except PENDANT FAULT, which is a single tone with continuous visual flashing. The audible tone volume is adjustable to low, medium, or high by accessing system settings during self-test at Start-up. It can also be accessed by pressing [SILENCE/VOLUME] when infuser is in RUN Mode. Select desired volume of alarm, then press SAVE AND EXIT> Softkey.NOTE: The infuser stops delivery when any of following alarms occur: CHECK INJECTOR, CHECK VIAL, CHECK SYRINGE, EMPTY SYRINGE, OCCLUSION, DEAD BATTERY or MALFUNCTION.
LifeCare PCA Infusion System 7 - 5430-04685-001 (Rev. 7/05)7.3 Silencing an AlarmTo silence an alarm, press the [SILENCE] key, then follow the displayed messages. All alarms except the MALFUNCTION, CHECK VIAL, CHECK INJECTOR, and CHECK SYRINGE, can be muted.Clear the cause of the alarm, if possible, and press the [START/PAUSE] key to resume operation for Continuous or PCA + Continuous Modes. The original display message will be restored.NOTE: If the MALFUNCTION alarm sounds, press the [ON/OFF] key to turn the infuser off. Turn the infuser on. If the malfunction repeats, remove infuser from service. Refer infuser to the hospital’s technical support or contact Hospira Technical Support Operations.NOTE: In the event two or more alarms conditions simultaneously occur, the alarm with shortest muting period will take priority and be displayed first.If the alarm is muted and a second alarm condition occurs during the muting period, an audible alarm signaling the new condition will immediately occur.NOTE: Alarm cadence can be configured for different sounds to differentiate between infusers in the Biomed Mode or by Hospira MedNetTM software.
7 - 6 Troubleshooting430-04685-001 (Rev. 7/05) 7.4 Alarms and Messages MESSAGEMUTING TIMESPOSSIBLE CAUSECORRECTIVE ACTIONBar code Not Read1 minute Vial not loaded properly• Position vial correctly• Clean bar code reader windowCheck Settings1 minute Door locked without appropriate therapy settings• Open the door. Complete settings.Occlusion 1 minute Occlusion detected• Open security door if closed. Remove back pressure by squeezing and releasing the cradle release handles. Identify and correct the cause of the occlusion. Alarm will self correct.Check SyringeNone Syringe (Vial and Injector) not properly loaded• Close Slide Clamp Immediately• Properly insert syringe into holder assemblyCheck Vial None Injector detected and vial not properly loaded• Properly insert vial into holder assembly or removal of injector
LifeCare PCA Infusion System 7 - 7430-04685-001 (Rev. 7/05)Check InjectorNone Vial is detected and injector not properly loaded• Properly insert injector into holder assembly or removal of vialDecimal Point Not Allowed!N/A Attempting to select the decimal point button when programming in micrograms (mcg).• Press [Clear] and enter valid whole number.Empty Syringe15 minutesEmpty vial detected• Press [Silence] to silence the alarm. Unlock and open the security door and squeeze and release handles in order to replace vial. May turn infuser OFF while preparing new vial.Door Open N/A Door left open or unlocked for more than 2 minutes• Close door and LockInfuser Paused5 minutesInfusion paused for more than 2 minutes• Press [START/PAUSE] key again, or unlock doorLow Battery 10 minutesBattery life has less than thirty minutes remaining and is currently operating on battery power• Apply AC power. failure to connect to AC power may cause battery damage.MESSAGEMUTING TIMESPOSSIBLE CAUSECORRECTIVE ACTION
7 - 8 Troubleshooting430-04685-001 (Rev. 7/05) Dead BatteryNone Battery life has expired• Apply AC powerPendant Fault - OVisible Flashing OccursPendant not secured into portFaulty Connection or pendantPartial Pendant pressUsing PCA Plus II Patient Pendant(white handle)• Secure pendant into port• Replace pendant or infuser• Release pendant button• Confirm use of PCA Patient Pendant(blue handle)Pendant Fault - SVisible Flashing OccursElectrical Short in pendant• Replace pendantCheck PCA Infuser Set to Relieve PressureNone Pressure in line possible occlussion and vial stiction• Verify proper placement of injector• Removal of vial and/or manual purge of vial and re-insert vial. MESSAGEMUTING TIMESPOSSIBLE CAUSECORRECTIVE ACTION
LifeCare PCA Infusion System 7 - 9430-04685-001 (Rev. 7/05)7.5 Infuser StallingIf Hospira MedNetTM Software is enabled and the infuser stalls or suspends communication with an external devices, such as the MMU, for an inordinate amount of time, discontinue use and send the infuser to the Biomed Department for restarting.
7 - 10 Troubleshooting430-04685-001 (Rev. 7/05)
LifeCare PCA Infusion System 8 - 1‘430-04685-001 (Rev. 7/05)Section 8 MaintenanceThe following topics are addressed in this section:•Infuser Storage •Cleaning and Sanitizing •Battery Maintenance •Service
8- 2 Maintenance430-04685-001 (Rev. 7/05) 8.1 Infuser StorageTo prolong the life of the PCA Infuser, observe the following storage precautions:•Store away from excessive heat, cold, and, humidity•Store the PCA Infuser connected to AC (mains) power•Switch off using the [ON/OFF] key8.2 Cleaning and SanitizingEstablish a routine infuser cleaning schedule to keep it contamination free.CAUTION: Always check that the bar code readerwindow is clean. Blood, fingerprints, condensation,and other elements may obstruct the view of the barcode reader. Elements on the window (other thanscratches) can be cleaned by using one of therecommended cleaning solutions in this section.CAUTION: To avoid mechanical or electronicdamage, do not immerse the PCA Infuser in any fluidsor cleaning solutions.CAUTION: Some cleaning and sanitizingcompounds may slowly degrade components madefrom some plastic materials. Do not use compoundscontaining combinations of isopropyl alcohol anddimethyl benzyl ammonium chloride.CAUTION: Do not sterilize by heat, steam, ethyleneoxide (ETO), or radiation. Apply disinfectants to theoutside surface of the infuser only. Using abrasivecleaners or cleaning solutions not recommended byHospira may result in product damage.CAUTION: To avoid infuser damage, cleaning
LifeCare PCA Infusion System 8 - 3‘430-04685-001 (Rev. 7/05)solutions should only be used as directed. Thedisinfecting properties of cleaning solutions vary;consult the manufacturer for specific information.CAUTION: Never use sharp objects such asfingernails, paper clips, or needles to clean any partof the PCA Infuser.Establish a routine weekly schedule for cleaning the infuser case, front panel, and patient pendant. To clean, proceed as follows:Turn the PCA Infuser off with the [ON/OFF] switch, then disconnect from AC power.The exposed surfaces of the PCA Infuser may be cleaned with a lint-free cloth dampened by one of the recommended cleaning solutions in the following list, or mild nonabrasive soapy water.Cleaning Solution Manufacturer PreparationManu-Klenz®Calgon Vestal LaboratoriesPer manufacturer's recommendationFormula C TM Diversey CorporationPer manufacturer's recommendationCoverageTMHBV Steris Corporation, A division of Calgon Vestal LaboratoriesPer manufacturer's recommendationSporicidin®Sporicidin InternationalPer manufacturer's recommendationDispatch®Caltech Industries Per manufacturer's recommendationPrecise®Caltech Industries Per manufacturer's recommendation
8- 4 Maintenance430-04685-001 (Rev. 7/05) On a routine basis, clean all of the elements behind the syringe door using cotton-tipped swabs saturated with cleaning solution. The door may be unlatched from the door handle to facilitate cleaning. WARNINGFailure to clean infuser’s outside surfaces afterpatient use may spread infection. Please followhospital infection protocols by cleaning the infuser forinfection control.No other routine maintenance is required; the infuser has no other user serviceable parts. All service must be carried out by Hospira qualified technical personnel. A technical service manual may be ordered from Hospira Technical Service.Household bleach Various Per hospital procedures; do not exceed one part bleach in ten parts waterCleaning Solution Manufacturer Preparation
LifeCare PCA Infusion System 8 - 5‘430-04685-001 (Rev. 7/05)8.3 Battery MaintenanceWARNINGDisconnect the AC power cord from AC supply beforeremoving the battery door.CAUTION: Do not operate the PCA Infuser onpatients with the battery removed. Use of a properlymaintained and charged battery helps ensure properoperation. CAUTION: If the low-battery alarm sounds, connectthe PCA Infuser to AC (mains) power immediately.The PCA Infuser is battery powered for emergency backup and temporary portable operation. A fully charged, conditioned battery provides 2.5 hours of continuous operation from start to low battery alarm, and will deliver at least 30 mL of solution. The battery charges whenever the PCA Infuser is connected to AC (mains) power. If the PCA Infuser is switched off, a recharge takes approximately 16 hours. The recharge takes longer if the PCA Infuser is turned on.As a general rule, the more often the battery is partially discharged and recharged, the sooner it will need to be replaced. Consult a qualified Biomedical technician for battery replacement if necessary.To maintain maximum battery charge and to prolong battery life, connect the PCA Infuser to AC (mains) power whenever possible.
8- 6 Maintenance430-04685-001 (Rev. 7/05) 8.4 ServiceAll servicing or adjustments to the PCA Infuser should be referred to qualified technical personnel. A technical service manual may be ordered from the local Hospira sales office.
LifeCare PCA Infusion System 9 - 1430-04685-001 (Rev. 7/05)Section 9 SpecificationsAdministration Sets:Use only compatible Hospira/Abbott PCA sets with Integral Anti-Siphon ValveAtmospheric Pressure:0 - 10,000 feet (0 - 3,000m) or equivalent pressureBattery:One sealed, lead-acid, rechargeable 8 V battery, internal to device. Accessible for ease of field replacement with color-coded leads and polarized connector.Battery Life:A conditioned battery at full charge should operate for at least 2.5 hours of continuous operation before a LOW BATTERY alarm. The PCA Infuser provides a LOW BATTERY warning at least 30 minutes prior to shutdown.Casing:High-impact plastic
9 - 2 Specifications430-04685-001 (Rev. 7/05) Delivery Rate:See Section 10 Prescription Delivery Limits on page 10- 1.Dimensions:Approximately 8”W 13”H 6”D, excluding pole clamp protrusion and power cord storage. Drug Concentration Settings:See Section 10 Prescription Delivery Limits on page 10- 1.Mode Delivery RatePCA Mode:Approximately 1 mL in 35 secondsCONTINUOUS Mode:Variable from 0.1 x concentration (mg/hr or mcg/hr) to 20 x concentration (mg/hr or mcg/hr)PCA+CONT. Mode:Variable from 0.1 x concentration (mg/hr or mcg/hr) to 20 x concentration (mg/hr or mcg/hr) + PCA dose (mg)
LifeCare PCA Infusion System 9 - 3430-04685-001 (Rev. 7/05)Electrical Safety:Meets IEC/EN/UL 60601-1 standards for:Electrical Leakage:Risk current limits meets standard IEC/EN/UL 60601-1Fuses:1.0 A, 250 V, Slow BlowingLockout Interval Range:5 to 120 minutes in 1- minute incrementsMaximum Infusion Pressure:45 psigSpec DescriptionClass 1:AC (mains) supply equipment using protective earthType CF:Equipment providing a higher degree of electyric shock protectionDrip Proof IPX1:The case is disinfectable and protected against dripping water. Note: Not to be used in the presence of flammable anesthesicsElectromagnetic Interference (EMI) and Radio Frequency Interference (RFI):The LifeCare PCA® is designed to perform in the typical hospital environmentA qualified service technician should verify performance in any environment where EMI or RFI levels are excessive
9 - 4 Specifications430-04685-001 (Rev. 7/05) Maximum Overinfusion:The maximum overinfusion under single fault conditions is 25%Occlusion Alarm Pressure:15 psig ± 5psigOcclusion Bolus Volume:2 mL for fully primed set (max)Operating Temperature:5° to 40° C, 10% - 90% relative humidityPower Cord:Hospital-grade AC cord, 10 ft. long, with transparent plug and retainer plate.Power Requirements:105-130 Volts, 57 - 63 Hz, <50 WPrinter Port:Maximum nondestruct voltage is 5 VRecharge:After discharge to the LOW BATTERY operative limit, the battery will recharge to at least 80% of its charge capacity in 16 hours, provided it is plugged into rated AC power. The infuser will operate on AC power in the event the battery is open or shorted.Self-Discharge:50% of charge retained for at least one month when unit is neither plugged-in nor operating.Storage Temperature:-20° to 60° C, 10% - 90% relative humidityWeight:Approximately 10 lbs. with battery
LifeCare PCA Infusion System 9 - 5430-04685-001 (Rev. 7/05)9.1 Stored Occlusion Volume9.2 Time from Occlusion to Alarm9.3 Delivery Rate AccuracyDelivery accuracy is ± 5% at continuous delivery rates greater than 1.0 mL/hr. For accuracy data at other flow rates, see the following typical trumpet curves. The under-delivery that may occur at rates less than 0.5 mL/hr or bolus volumes less than 0.5 mL may be substantially greater than 5%, and is due primarily to the variability of friction between the syringe plunger and barrel. This under delivery may include periods of no delivery. DELIVERY RATEPRESSURE LIMIT (Average)bSTORED VOLUME (Average)0.1 mL/hr 12.8 psig 0.92 mL5 mL/hr 12.6 psig 0.94 mL20 mL/hr 12.7 psig 0.96 mLDELIVERY RATEPRESSURE LIMIT (Average)bTIME TO OCCLUDE (Average)0.1 mL/hr 12.8 psig 12 hours5 mL/hr 12.6 psig 11 minutes20 mL/hr 12.7 psig 3 minutes
9 - 6 Specifications430-04685-001 (Rev. 7/05) If multiple, partial PCA doses are delivered, the accumulated total reflected in the history totals may be more than the sum of the PCA doses logged in the event log. This is due to the fact that only a portion of the next 0.1 mg (or 1 mcg) may have been delivered at the time any of the PCA doses were interrupted. As these portions accumulate, their combined total may account for 0.1 mg (or 1 mcg).TRUMPET CURVESThe typical trumpet curve graphs following the example show representative maximum and minimum percent flow rate deviation from the programmed rate over time. This information was developed in accordance with IEC 60601-2-24: 1998, Sub-Clause 50.102. Refer to this standard for detailed information.Refer to the Example on page 9- 6 to read a Trumpet Curve Graph. The graphs following the Example, plot flow rates at 30 second intervals for the first 2 hours and for the 96th hour of delivery. The graph plots mean delivery rate error (Average of 3 infusers) for the 2nd hour and the 96th hour as a straight line. The graph presents maximum and minimum average delivery rate error for this interval plotted by averaging delivery errors over intervals of 2, 5, 11, 19 and 31 minutes (“Trumpet Curve”).EXAMPLEFrom the Trumpet Curve Graph sample that follows, find the 5 minute interval (A) at the horizontal axis and read the corresponding points (B) and (C) on the vertical axis. The values are approximately +2.8% and -0.5%.This means that at the rate of 25 mL/hr the average maximum flow rate fluctuation for any 5 minute time interval during the 2nd hour of operation was within the limits of +2.8% and -0.5% from the nominal rate. The average delivery rate error over the entire 2nd hour was +1.6% (D).
LifeCare PCA Infusion System 9 - 7430-04685-001 (Rev. 7/05)For other time intervals look at other points at the horizontal axis and determine corresponding limits as above.A trained professional can use the resulting graphs to select a infuser with the appropriate startup and flow characteristics to suit the clinical application.NOTE: As an example of how the trumpet curves may be used, consider the maximum and minimum deviations at the 5 minute average interval. The upper curve provides the maximum expected delivery rate error over a 5 minute interval, the lower curve provides the minimum expected delivery rate error over a 5 minute interval. An example would be Morphine administered at 5 mL/mg. At 5 minutes, the average drug delivery error would be within the range of +2.8% and -0.5% of the expected nominal rate.0510 15 20 25 3015.0%10.0%5.0%0.0%-5.0%-10.0%-15.0%25 ML/HR, 0 mm Hg DELIVERY HEAD, START UPPERCENT ERROR (%)Observation Interval (minutes)+++++Max Mean+MinAverage DeliveryRate Error = +1.6%ADMax Negative Error over 5Minute Interval = -0.5%CMax Positive Error over 5Minute Interval = +2.8%B
9 - 8 Specifications430-04685-001 (Rev. 7/05) 9.4 Trumpet CurvesPCA, 0.1 ml/hr, 0 mmHg Delivery Head, 0.9% SalineMaxima/Minima of 3 Pumps-100.0%-80.0%-60.0%-40.0%-20.0%0.0%20.0%40.0%60.0%80.0%100.0%0 5 10 15 20 25 30Observation Interval (min)PCA, 1 ml/hr, 0 mmHg Delivery Head, 0.9% SalineMaxima/Minima of 3 Pumps-15.0%-10.0%-5.0%0.0%5.0%10.0 %15.0 %0 5 10 15 20 25 30Observation Interval (min)Max Min MeanPCA, 5 ml/hr, 0 mmHg Delivery Head 0.9% SalineMaxima/Minima of 3 Pumps-15.0%-10.0%-5.0%0.0%5.0%10.0 %15.0 %0 5 10 15 20 25 30Observation Interval (min)Max Min Mean
LifeCare PCA Infusion System 9 - 9430-04685-001 (Rev. 7/05)PCA, 5 ml/hr, -100 mmHg Delivery Head, 0.9% SalineMaxima/Minima of 3 Pumps-25.0%-20.0%-15.0%-10.0%-5.0%0.0%5.0%10.0 %15.0 %0 5 10 15 20 25 30Observation Interval (min)Max Min MeanPCA, 5 ml/hr, +100 mmHg Delivery Head, 0.9% SalineMaxima/Minima of 3 Pumps-15.0%-10.0%-5.0%0.0%5.0%10.0 %15.0 %20.0%0 5 10 15 20 25 30Observation Interval (min)Max Min MeanPCA, 20 ml/hr, 0 mmHg Delivery Head, 0.9% SalineMaxima/Minima of 3 Pumps-15.0%-10.0%-5.0%0.0%5.0%10.0 %15.0 %0 5 10 15 20 25 30Observation Interval (min)Max Min Mean
9 - 10 Specifications430-04685-001 (Rev. 7/05)
LifeCare PCA Infusion System 10 - 1430-04685-001 (Rev. 7/05)Section 10Prescription Delivery LimitsPrescription delivery limits for the loading dose, PCA dose, dose limit, and continuous delivery rate parameters vary with the drug and concentration selected. See Table 10.1 on page 10-2 and Table 10.2 on page 10-3 for listings of the lower and upper limits.NOTE: Drug and concentration selections are rounded up to the nearest tenth of a digit for mg/mL values or to the nearest digit for mcg/mL values. Minimum delivery rate is 0.1 mL/hr for concentrations between 0.1 and 1 mg/mL.
10 - 2 Prescription Delivery Limits430-04685-001 (Rev. 7/05) Notes: 1Pump will reject values > 999.9 mg Pump will reject values < 0.1 mg Lockout interval range is 5 to 120 minutes (increments of 1 minute)Conc. = Concentration PF = preservative-freeSee current product sales catalog for available drugTable 10.1: PCA Drug And Dose Limits (Pre-Filled Vials)Drug(Pre-filled vials)Conc.(mg/ mL)Loading Dose(mg)PCA dose(mg) min- maxCont. rate(mg) min- max1 hr limit(mg) min- max4 hr limit (mg)min- max6 hr limit(mg) min- max12 hr limit(mg) min- maxMorphine Sulfate PF1 0.1-10 0.1-5 0.1-20 0.1- 20 0.1- 80 0.1 - 120 0.1 - 240Morphine Sulfate 5 0.5-50 0.5- 25 0.5- 100 0.5- 100 0.5- 400 0.5 - 600 0.5 - 999.91Meperidine HCI10 1 -100 1- 50 1- 200 1- 200 1- 800 1 - 999.911 - 999.91
LifeCare PCA Infusion System 10 - 3430-04685-001 (Rev. 7/05) Notes: 1Pump will reject values > 999.9 mg as well as those > 9999 mcg Pump will reject values < 0.1 mg as well as those < 1 mcgLockout interval range is 5 to 120 minutes (increments of 1 minute)C = Concentration ValueSEV = sterile empty vialSee current product sales catalog for available drugsTable 10.2: PCA Drug And Dose Limits (Custom Vials)Drug(Custom vials)Conc. (C) Range (units/ mL)Loading DosePCA dose min- maxCont. rate(units/hr)min- max1 hr limit min- max4 hr limit min- max6 hr limit min- max12 hr limit min- maxSterile Empty Vial (without Hospira MedNet)mg units 0.1 - 10 [0.1-10] X C [0.1-5] X C [0.1-20] X C [0.1-20] X C [0.1-80] X C -- --mcg units 1 - 100 [0.1-10] X C [0.1-5] X C [0.1-20] X C [0.1-20] X C [0.1-80] X C -- --Sterile Empty Vial with Pharmacy-Generated Barcode (with Hospira MedNet)mg units 0.1 - 50 [0.1-10] X C [0.1-5] X C [0.1-20] X C1[0.1-20] X C1[0.1-80] X C1[0.1-120] X C1[0.1-240] X C1mcg units 1 - 500 [0.1-10] X C [0.1-5] X C [0.1-20] X C1[0.1-20] X C1[0.1-80] X C1[0.1-120] X C1[0.1-240] X C1
10 - 4 Prescription Delivery Limits430-04685-001 (Rev. 7/05)
LifeCare PCA Infusion System A - 1430-04685-001 (Rev. 7/05)Appendix AGenerating Bar Code Labels (Hospira MedNetTM Software Enabled)Hospira recommends that the hospital or pharmacy department develop clear policies and procedures for the following:• Generating Bar Code Labels• Applying Labels to Empty Sterile Vials• Filling Labeled Empty Sterile Vials• Validating Correctly Filled and Labeled VialsIncorrect labels or filled vials may lead to significant and potentially fatal adverse events. The following are general specifications for producing labels containing pharmacy-generated bar codes for custom drugs. These labels are adhered on the Hospira/Abbott Sterile Empty Vials, and should cover the entire existing Sterile Empty Vial bar code. The proper placement of the pharmacy-generated bar code label on the Sterile Empty Vial is shown in the Label Diagram on page A-4. Correct placement of the pharmacy-generated bar code on the Sterile Empty Vial helps ensure proper reading of the bar codes by the LifeCare PCA® Infuser.
A - 2 Generating Barcode Labels430-04685-001 (Rev. 7/05) Equipment:1. Bar code thermal printer - 300 DPI or higher2. Bar code label software capable of producing labels• ANSI X3.182-1990• EAN/UCC Code 128, Code Set C (numeric characters only)• ANSI Grade C or better• 10 mil (0.010 inches) pitch minium• Bar code height is 1 inch• 18 Characters max3. Opaque polyester labels, (non-paper labels) which are water and smudge resistant, are recommended.
LifeCare PCA Infusion System A - 3430-04685-001 (Rev. 7/05)EXAMPLE OF LABEL LAYOUT & SAMPLEExample of a pharmacy-generated bar code label on a PCA vial. The plunger is shown for reference. The human readable label is on the right side of the vial and is not shown on this illustration.
A - 4 Generating Barcode Labels430-04685-001 (Rev. 7/05) LABEL DIAGRAMThe label diagram below depicts the area where the bar code image must be placed within the dimensions shown. The copy area (length and width must be as specified +/- 1/32”. The center bar code includes 1/4” quiet zone on each side of the bar code. The bar code and comodity number must be black on a white background.
LifeCare PCA Infusion System A - 5430-04685-001 (Rev. 7/05)The dimensions shown on the previous label diagram represent Hospira's recommendation for placement of the bar code and drug name/concentration on a 2"x3" label.The guidelines ensure the device's integral bar code reader will align correctly with the bar code on the PCA vial. Your institution may choose to use a different format for placement of the drug name and concentration based on your specific hospital guidelines or size of the label. However, it is recommended that the system be validated before use.
A - 6 Generating Barcode Labels430-04685-001 (Rev. 7/05)
LifeCare PCA Infusion System B - 1430-04685-001 (Rev. 7/05)Appendix BNetwork Printer SetupThis section provides information about the printing function. Equipment needed• Infuser• Computer meeting the printer setup require-ments• Network crossover cablePreparation• Connect the crossover cable between the printer network port and the computer.• Plug infuser & printer into AC power • Turn on the infuser and printerProcedure1. Identify the printer IP settings - refer to printer operating instructions.2. Using the printer operating instructions, configure the printer to match the infuser’s printer network settings: the IP address is 192.168.0.222 and subnet mask 255.255.0.03. Test the installationDisconnect the crossover cable from the PC and connect it to the infuser. Power up the infuser and print the history log.
B - 2 Network Printer Setup430-04685-001 (Rev. 7/05) PRINTING EVENT HISTORY LOGThe history event log can be printed by connecting the infuser to a network ready printer. Use the previous instruc-tions to configure the printer.WARNINGDisconnect the infuser from the patient beforeconnecting the infuser to a printer or computer.To print from the PCA Infuser, complete the following steps:1. Load printer with paper.2. Connect a network crossover cable between the printer and the infuser. 3. Plug infuser & printer into AC power. 4. Turn-on infuser. 5. Press [History] touch switch to view the history on the display.6. Press Print HISTORY> Softkey to print history log. NOTE: After the infuser is turned on to initiate printing, please allow 2-3 minutes for the infuser to complete start-up before attempting to print the event log. If the entire log is not successfully printed, reprint the log by pressing the Print HISTORY> Softkey .
LifeCare PCA Infusion System B - 3430-04685-001 (Rev. 7/05)DOWNLOADING LOGS TO A PCEquipment needed• Infuser• PC with Hyper Terminal program • Network crossover cablePreparationConnect the crossover cable between the computer and the infuser. Turn on the infuser and the PC.Procedure1. Create a Hyper Terminal connection.
B - 4 Network Printer Setup430-04685-001 (Rev. 7/05) 2. Create a PCA Events connection setting:3. Establish the connection settings.• Host address is the IP address of the infuser that connected to the PC.• Port number is 8889 where the infuser will send the events to the PC.• Connect using TCP/IP protocol.
LifeCare PCA Infusion System B - 5430-04685-001 (Rev. 7/05)4. The Hyper Terminal program is ready to receive events sent from the infuser.5. Printing to a PC.• To print from the PCA Infuser, complete the following steps:• Press [History] touch switch to view the history on the display.• Press Print HISTORY> Softkey to print history log.
B - 6 Network Printer Setup430-04685-001 (Rev. 7/05)
LifeCare PCA Infusion System C- 1430-04685-001 (Rev. 7/05)Appendix C WarrantySubject to the terms and conditions herein, Hospira, Inc., herein referred to as Hospira, warrants that (a) the product shall conform to Hospira's standard specifications and be free from defects in material and workmanship under normal use and service for a period of one year after purchase, and (b) the replaceable battery shall be free from defects in material and workmanship under normal use and service for a period of 90 days after purchase. Hospira makes no other warranties, express or implied, as to merchantability, fitness for a particular purpose, or any other matter.Purchaser's exclusive remedy shall be, at Hospira's option, the repair or replacement of the product. In no event shall Hospira's liability arising out of any cause whatsoever (whether such cause be based in contract, negligence, strict liability, other tort, or otherwise) exceed the price of such product, and in no event shall Hospira be liable for incidental, consequential, or special damages or losses or for lost business, revenues, or profits. Warranty product returned to Hospira must be properly packaged and sent freight prepaid.The foregoing warranty shall be void in the event the product has been misused, damaged, altered, or used other than in accordance with product manuals so as, in Hospira's judgment, to affect its stability or reliability, or in the event the serial number or lot number has been altered, effaced, or removed.The foregoing warranty shall also be void in the event any person, including the Purchaser, performs or attempts to perform any major repair or other service on the product without having been trained by an authorized representative of Hospira and using Hospira documentation and approved spare parts. For purposes of the preceding sentence, “major repair or other service” means any repair or service other than the replacement
C- 2 Warranty430-04685-001 (Rev. 7/05) of accessory items such as batteries and detachable mains power cords.In providing any parts for repair or service of the product, Hospira shall have no responsibility or liability for the actions or inactions of the person performing such repair or service, regardless of whether such person has been trained to perform such repair or service. It is understood and acknowledged that any person other than an Hospira representative performing repair or service is not an authorized agent of Hospira.
LifeCare PCA Infusion System D - 1430-04685-001 (Rev. 7/05)Appendix DContact InformationFor customer service within the United States, contact:1-877-9-HOSPIRA (1-877-946-7747)For technical assistance, product return authorization, and to order parts, accessories, or manuals within the United States, contact Hospira Technical Support Operations.1-800-241-4002To order parts using the online eCatalog, download technical publications, technical training courses, and additional services, visit the web site at:WWW.HOSPIRAPARTS.COMAfter authorization, ship prepaid product returns to this address:HOSPIRATechnical Support Operations755 Jarvis DriveMorgan Hill, CA 95037NOTE: Outside the U.S. contact your local Hospira sales office.CAUTION: Federal (USA) law restricts the sale of thisinfuser. It can only be procured by the order of aphysician or other licensed practitioner.The PCA Infuser, Hospira MedNet, LifeShield, and E.L.I. aretrademarks of Hospira. Teflon, Formula C, Manu-Klenz, SuperEdisonite, Coverage, and Sporicidin are not trademarks ofHospira. Patents Pending.
D - 2 US FCC Statement430-04685-001 (Rev. 7/05)
LifeCare PCA Infusion System I - 1430-04685-001 (Rev. 7/05)Numerics24-Hour information 5-394 HR LIMIT 5-214 HR LIMIT REACHED Message 5-21AAC power 1-2indicator 3-7Accuracy 1-7alarm 1-9system 2-2Alert messages 1-6Alpha Vial 4-9analgesic 1-3, 2-2delivered 4-6, 4-14, 4-33, 6-7package 1-13anesthetics 1-3anti-siphon valve 1-13Autoprogramming 1-7Bbar code 1-11drug vial 1-2pharmacy-generated 1-2, 4-8, 6-2reader 1-2, 1-16battery 1-2, 1-12, 1-15, 1-18charge 4-17fault 1-7indicator 3-7Biomed Mode 1-2, 5-2, 5-18bolus 1-7, 2-2, 4-32doses 1-10partial 5-38Button 1-7CCAUTIONmessage 1-6CCA 1-7, 1-10, 1-11, 6-4, 6-8CE 1-7Change CCA 5-33Softkey 5-25, 5-31Change Rx Softkey 5-31cleaninginfuser 1-16Clear Button 3-5, 4-12Clear History 5-39Clear Shift Softkey 5-34Clinical Care Area 1-7(CCA) 6-8clock12 hour 4-2724 hour 4-27Confirm No Dose Limit Screen 5-22,5-24Confirm Softkey 5-26Confirmation Screen 4-28, 5-36Connectivity Engine 1-7Continuous 1-2, 1-7, 2-2, 5-3, 5-36infusion 5-3mode 1-14, 2-2, 5-3rate 5-11, 5-15CONTINUOUS ONLY 1-2custom syringes 1-14DDDL 1-8, 5-21DECIMAL POINT Button 3-6Default Drug Library 1-8, 5-21Defined Drug Library 6-8Deliver Later Option 4-6, 4-14, 4-33,6-6Deliver Loading Dose Now Screen 4-5,4-13, 6-6Delivery 1-13interruption 5-2Mode Screen 5-5, 5-10Modes 5-21Parameters 1-10Screen 1-9Door Locked Message 5-8Index
LifeCare PCA Infusion System I - 2430-04685-001 (Rev. 7/05)Dose History 1-14, 5-21Dose Limit 1-8, 1-10, 1-14, 2-1, 5-2, 5-3, 5-16, 5-21, 5-22new 5-21pre-programmed 5-11Dose Limit Enter Value Screen 5-6, 5-11, 5-16, 5-22Dose Limit Periods 5-2, 5-21DOSE LIMIT REACHED State 5-2Dose Limit Selection Screen 5-22, 5-24drug concentration 1-11, 1-14, 4-12,4-32drug delivereddisplay 4-30drug identification 1-2Drug Library 1-11Download 1-8Installation 1-8Eelectromagnetic compatibility 1-22electromagnetic interference 1-20empty syringe message 5-35ENTER Button 3-5epidural 1-3epidural infusion system 4-19epidural route 1-17, 2-2epidural space 1-18Ethernetcable 1-21port 1-2, 3-8Event HistoryHOUR-BY-HOUR 5-40LAST 1 & 24 HOUR 5-40Event Log 1-8, 5-39Events recorded 4-17EXIT Button 3-5FFCC Rules 1-23flow rate 1-14, 4-30Front Pannelequipment description 3-2Hhard limit 1-10, 5-16History 1-8HOUR-BY-HOUR 5-40LAST 1 & 24 HOUR 5-40History and Rxsettings 4-3, 4-9, 5-28, 6-3History Button 3-6, 5-31, 5-38, 5-40History Printout 5-41Hospira MedNet Software 1-1, 1-2, 5-2, 5-6, 5-11, 5-16, 5-18, 5-22HOUR-BY-HOUR history 5-40HR LIMIT REACHED message 5-3Iincompatibility 1-13infuse 1-9Loading Dose 6-6infuser 5-30cleaning 1-16maintenance 1-16sets 1-17infusion rate 1-13infusion therapy 1-10injector 1-13Kkeypad controls 1-2LLCD 1-9LED 1-9, 3-7Loading Dose 1-9, 1-14, 2-1, 4-5,4-12, 4-32, 5-5, 5-10, 5-14, 6-5,6-6Deliver Later 5-10displayed range 5-5, 5-10, 5-14halt 5-37infuse 4-6, 4-13, 4-33mode 4-6, 6-6now 4-33range 4-5, 4-13, 4-32, 6-5softkey 5-21supplemental 2-2, 5-21, 5-37
430-04685-001 (Rev. 7/05)LifeCare PCA Infusion System I - 3Lockout Interval 1-9, 1-10, 2-2, 5-2,5-3value 5-6Low Battery Alarm 1-18Low Battery Message 4-17Low Priming Volume PCA Set 2-2lower limits 1-10MMain Delivery Screen. 5-39malfunction alarm 1-17, 5-2, 5-38Medical Device Directive93/42/EEC (EN 55011 Class B 1-20IEC/EN 60601-1-22001 1-20micrograms 4-12Modes of DeliveryCONTINUOUS 1-2, 5-2PCA ONLY 1-2, 5-2PCA+CONTINUOUS 1-2, 5-2Muting Period 1-9NNew Patient Screen 4-3, 4-9, 4-17,4-29, 5-4, 5-9, 5-13, 5-28, 6-3Next Protocol Softkey 5-19No Dose Limit 5-7, 5-26numeric buttons 3-6Nurse Call Jack 3-8OOcclusion 1-9Pressure 1-9ON/OFF Button 3-5, 6-2one hour information 5-39operating parameters 2-1Ppartial doses 5-2Patient Pendant 1-2, 1-3, 1-4, 1-10,1-14, 3-8, 4-16, 5-2patient pendantbutton 5-2PCA 1-2, 2-1requested doses 5-40PCA + Cont. 6-8PCA + Continuous 2-2, 5-3, 5-36mode 1-14, 5-21PCA AVAILABLE Message 5-2, 5-3PCA bolus 5-17PCA dose 2-2, 5-17PCA Infusion System 1-1, 1-2PCA LOCKOUT Message 5-8PCA Mode 1-10PCA Only 1-2, 5-2, 5-5PCA Patient Pendant 3-8PCA Set 1-10PCA Vial 1-10PCA+CONTINUOUS 1-2Pendant Fault Message 5-8Prime 1-10, 1-13, 5-36system 4-30Print History 5-38Softkey 5-40printer connections 1-2printouts 5-41procedures 1-13program valueschange 5-29programmed therapy 1-11programming features 1-2Protocols 1-2, 1-11, 5-2, 5-18, 5-19, 6-8stored 5-2purge 1-10, 1-13, 5-35, 6-4complete 4-4cycle 1-13, 4-30system 4-30Purge Softkey 4-4, 4-10, 4-31, 5-4,5-9, 5-13, 6-4RRear Panelequipment description 3-4replace syringe message 5-35Review/Confirmation Screen 5-27, 5-29RF communications 1-21Rule Set 1-10
LifeCare PCA Infusion System I - 4430-04685-001 (Rev. 7/05)Rx Rules 1-11, 5-18Rx Settings 1-11Ssafety 1-13Save & Exit Softkey 5-27screen message alerts 5-2Select CCA Screen 6-8Select Delivery Mode 4-33Screen 4-6, 4-14, 6-6Select ModePCA + Cont 5-14PCA Only 5-4Screen 4-32self-test 1-16, 4-2, 4-8failures 4-16set 4-4, 4-10, 4-11, 4-31, 5-4, 5-10, 5-13, 6-4, 6-5Set List 1-19settings 5-30, 5-39adjust system 5-4, 5-9, 5-13SILENCE key 1-9SILENCE/VOLUME button 3-5slack 1-14, 4-30, 5-36soft limits 1-10, 5-16Softkeys 1-11, 3-7Standard Syringe 1-11START/PAUSE Button 3-6, 5-3, 5-8START/STOP Button 5-2status messages 7-2stopping infusion 5-30Stored Protocols 1-11syringe 1-13, 1-14change 1-14, 4-30custom 1-2, 1-8System Settings 4-23system slack 4-4, 4-10, 4-30, 6-4Ttherapy settings 1-11, 5-40traininginfuser use 1-3IV complication 1-3PCA programming 1-3Uunits of measure 4-11unpacking 1-12upper limits 1-10User-Defined Drug Library 1-10, 1-11, 5-2, 5-3, 5-21, 6-2Vvial 1-13, 5-2barcoded 1-2custom 1-8, 1-10, 4-8, 6-2custom-filled 1-2load drug 4-2PCA 1-10prefilled 1-2, 1-10, 1-11, 6-2removal 5-35standard 1-10sterile empty 1-2, 1-8Vial Confirmation Screen 4-28Vial Cradleequipment description 3-3vialsprefilled 1-11WWarning 1-11warning messages 1-6Warning! Drug and/or ConcentrationChange Detected Screen 5-35

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