BIOTRONIK SE and KG RENAMIC Medical Programmer and Monitoring Device User Manual Renamic

BIOTRONIK SE & Co. KG Medical Programmer and Monitoring Device Renamic

QRIRENAMIC_UserMan

3Table of Contents Table of ContentsTable of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5About the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5About this Technical Manual. . . . . . . . . . . . . . . . . . . . . . . . . . 6Safety During Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Required Expertise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Residual Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . 10Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Electromagnetic Interference. . . . . . . . . . . . . . . . . . . . . . . . 14Maintenance, Care and Disposal . . . . . . . . . . . . . . . . . . . . . 15Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Device Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Transportation and Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Connections and Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Switching On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Using Renamic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Keys, Displays and Signals . . . . . . . . . . . . . . . . . . . . . . . . . . 31Emergency Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Programming Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Communication with Active Implanted Devices . . . . . . . . . 38Using the Internal Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Using an External Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . 42ECG and IEGM Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Scope of Delivery and Accessories. . . . . . . . . . . . . . . . . . . . 49Electromagnetic Compatibility in Compliance with EN 60601-1-2:2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Country-Related Information . . . . . . . . . . . . . . . . . . . . . . . . 54Symbols on the Components . . . . . . . . . . . . . . . . . . . . . . . . 55Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Directories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59List of Keywords. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59377213--D
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51 IntroductionIntroduction1xxxxxx--XDoc-classRenamicAbout the DeviceGeneral description Renamic is a portable programmer and monitoring device.According the customer specification the device is equipped with a GSM, UMTS or WIFI module. This enables the direct export of patient data from Renamic to hospital or practice networks.It is used during the implantation procedure and follow-up of implantable pulse generators and ICDs (implantable cardioverter-defibrillators).Primary functions The device has the following primary functions: Function PurposeProgramming and testing functionsProgram BIOTRONIK pacemakers and ICDs during the implantation procedure or follow-upsECG recorder and ECG monitorDisplay and printout of up to three leads of surface ECGs, as well as up to three intracardiac deriva-tions (IEGMs) and the corresponding event markers, in real-timeData management Store parameter values and ECG/IEGM recordings for computer-aided archiving and evaluationDocumentation Print out follow-up reports using the internal and/or external printer
6IntroductionAbout this Technical ManualObjective This technical manual provides the user with all the safety information required to use the Renamic programmer.The following topics are covered in this manual:•Device startup• Interrogation, testing and programming of implantable pulse generators and cardioverter-defibrillators (ICD)Target group This technical manual is intended for physicians and trained medical personnel who are familiar with the following:• The use of implantable pulse generators and ICDs • The risks and possible complications associated of using these systemsAdditional requirements include: • Medical knowledge:— Basic medical knowledge of the therapy applied— Training in the handling and programming of implantable pulse generators and ICDs• Technical knowledge:— Ability to work with a PC — Ability to use software-controlled medical devicesOther technical manuals • Technical software manual for programming the intended implantable pulse generator / ICD• Technical manual for the intended implantable pulse generator / ICD
72 Safety During Use Safety During Use2xxxxxx--XDoc-classRenamicIntended Medical UseIntended medical use The Renamic programmer provides communication with the implantable pulse generator or ICD during the implantation procedure or follow-ups. The Renamic programmer is intended to be used for the following tasks:• Conduct sensing, pacing threshold and impedance tests• Interrogate data of the implanted device such as program parameters, recorded statistical data and episodes, as well as real-time IEGMs• Display, printout, save and export data of the implanted device for analysis and reporting purposes• Transfer parameters to the implanted device
8Safety During UseRequired ExpertiseRequired expertise The programmer is intended for use by physicians and trained medical staff. Along with their basic medical knowledge, a detailed knowledge of cardiac electrotherapy is also required. Only qualified medical specialists with knowledge of cardiac elec-trotherapy can properly operate the device.German medical deviceordinanceThis ordinance only applies in the Federal Republic of Germany. However, we recommend that customers in other countries comply with this ordinance as well.According to section 2, § 5, operation and use:'The user may operate a (...) listed medical product only after the manufacturer or the authorized agent who acts on behalf of the manufacturer has performed the following requirements:• 1. Checked the functionality of this medical product at the location where the device will be used. • 2. Trained the staff appointed by the user to correctly handle, use and operate the medical product. This training must include handling, using and operating the product in conjunction with other medical products, implements and acces-sories in accordance with the technical manual, as well as any applicable safety-related information and maintenance instructions. (...)(3) Proof of a functional test have been performed as stated in Paragraph 1 Item 1, and the training record of the staff appointed by the user, discussed in Paragraph 1 Item 2, are to be documented.'
9Safety During UseResidual RiskRisk analysis The risk analysis carried out by the manufacturer's Risk Management Team has determined that the residual risk is as low as reasonably possible.It is a prerequisite that the programmer has been serviced and inspected according to the manufacturer's specifications by qualified medical staff and in compliance with the safety-relevant instructions in this technical manual.
10 Safety During UseGeneral Safety InstructionsTechnical manual Only use the programmer in accordance with this technical manual.Risks of improper handling Disregarding the safety instructions can endanger the patient, the staff and the equipment.The following dangers may arise in the event of improper use: • Failure of important device functions• Personal endangerment due to electrical effectsChanges not permitted Only the manufacturer or a party expressly authorized by BIOTRONIK may perform corrective maintenance, enhancements or modifications to the device.Replacement parts andaccessoriesTo ensure safety compliance, use only original replacement parts and accessories authorized by BIOTRONIK. Using any other parts voids the manufacturer's liability for any consequences, guarantee and warranty.Defects Do not use defective or damaged devices.Physician supervision The device should only be used under the constant supervision of a physician. During operation of the device, it is necessary to monitor the patient’s heart rate and ensure that for each stimulation, the display of events and their results (using an external ECG monitor) is plausible.Patient observation Ensure that patients are individually observed over a suitable period of time in order to monitor the compatibility and effectiveness of parameter combinations.Emergency equipment Always ensure that in the event of an emergency the following basic equipment is available: •Defibrillator• Intubation set•Oxygen•Emergency drugsFor pacemaker-dependent patients, an additional external pacemaker must also be available.Life support system Do not use this device as a life support system.Liquids • Never use a damp or wet device.• Protect the device from the accidental ingression of fluids (e.g. infusion fluids).Electrostatic potentials Ensure that electrostatic potentials between medical staff and patients are balanced. Before handling the device, the electrostatic potential between the doctor or medical staff and the patient must be balanced by touching the patient at a point as far away from the leads as possible.Note: Failure to observe the safety precautions voids all damage claims and manufacturer liability.
11 Safety During UseExternal ECG device During the implantation procedure, the patient's heart rate should be additionally monitored using an ECG monitor or ECG recorder.Defibrillation • When connected with the authorized ECG cable, the device is protected against defibrillation energy. Following a defibrillation, check all functions of the programmer.• During defibrillation, do not touch the patient, the programmer the patient is connected to or the attached accessories. Otherwise, there is a danger that you may suffer an electrical shock.
12 Safety During UseOperating ConditionsStorage and transportation • If the packaging is damaged, please contact BIOTRONIK immediately. Do not put the device into operation.Installation site Only operate the device in rooms that fulfill the following conditions:• No danger of explosion• Suitable for medical purposes• Class I power outlet with protection cable connectionPlace the device on a flat, dry surface. It should be placed so that it can not slip even with the cable connected and so that the patient can only come into contact with the applied parts, namely the programming head and ECG cable.Power supply The device is operated via the 230 V / 50 Hz or 115 V / 60 Hz AC current of a room used for medical purposes. The electrical port must fulfill the following conditions:• The network installation fulfills at least the requirements of IEC 60364-7-710:2002 group 1.• The device cable feeds directly into a permanently installed socket. No portable power strips are connected in between.• When used in combination with other devices, no portable multiple socket outlets should be used.• Only those power connection cables can be used which are suitable for medical devices, e.g. BIOTRONIK power cords (see Accessories, p. 49) or power cords of equal value labeled H05VV 3 x 0.75 mm, H05VV 3 x 1 mm or SJT AWG18.Cable and plug connections • Replace any cable that shows even slight damage.• Lay all cables between the patient and the device, as well as within the measuring apparatus, in such a way that they pose no danger of tripping over them and that any tensile forces that may occur can be safely buffered.• As a general rule, cables should only be connected or disconnected when the device is switched off, unless expressly permitted in the corresponding section of this technical manual.• Ensure that the contacts of all connections and plugs are clean. Soiled contacts can lead to signal distortions, and thus to false diagnoses.• Ensure that there is no condensation on the plugs or in the connector ports. If condensation is present, dry it before use.• Do not force plugs into the connector ports and when disconnecting the plugs, do not pull on the cable to release the lock.• All lead connections are swap-safe and encoded at the lead connectors.Patient environment This device may be used in the patient environment. CAUTIONFunctional impairment due to external damageMechanical impact, for example dropping the unit - even from a height of over 5 cm if unpackaged - can permanently impair the function of the system.• Do not use the device if it shows visible damage.• Contact BIOTRONIK for testing and, if necessary, repair of the equipment.
13 Safety During UsePlace the device on a flat, dry surface so that the patient can only come into contact with the applied parts, namely the programming head and ECG cable.The physician must not touch any connections such as USB ports or interfaces for modules or the programming head and the patient at the same time.Use with other devices The device may not be used on the patient in conjunction with high frequency surgical equipment. Start parameters anddefault settingsOnce switched on, the device functions according to BIOTRONIK's default settings or the user-defined start parameters.Note: In addition to BIOTRONIK's default start parameters, the user-defined start parameters can also be saved and recalled.
14 Safety During UseElectromagnetic InterferencePossible electromagneticinterferenceThe programmer is protected from disturbances resulting from electromagnetic interference, electrostatic discharges and other sources, including interference from cables. Simultaneously, the emitted interference has been reduced to a minimum. Thus the programmer conforms to the requirements of EN 60601-1-2 (in its valid form at the time of delivery).However, strong electromagnetic interferences that occur in the close vicinity of electrical motors, power cables, PCs, monitors, or other – possibly defective – elec-trical devices may compromise the function of the programmer in certain cases.This kind of device malfunction should be considered if the following is observed:• The device switches on by itself.• The device senses false intrinsic events in the ECG, IEGM or marker channel (artifacts).• The device displays other inexplicable functions.Correct operation of the device can be restored with the following: • Switch off the malfunctioning electronic device.• Remove the source of interference from the device.• Switch the programmer on and off or break the electrical connection between the device and the source of the interference as much as possible without causing any danger.If the interference continues, contact BIOTRONIK immediately.EMI test The telemetry between the programming head and the implanted device can be impaired by electromagnetic interference (EMI). This can be observed when it becomes difficult or even impossible to interrogate or program the implanted device. Using the EMI test (refer to device software help), the source of the electro-magnetic interference can be located and then turned off.Note: If accessories other than those specified by BIOTRONIK are used, increased interference or lower resistance to interference can be expected.Note: If accessories specified by BIOTRONIK are used on other devices, increased interference or lower resistance to interference can be expected.Note: Portable radio communication devices can interfere with the programmer functioning.
15 Safety During UseMaintenance, Care and DisposalThe following regulations are valid for the device. Cleaning and disinfecting • Use lint-free, soft cloths.• Clean the housing with a damp cloth and mild soap solution or 70% isopro-panol.Disinfect with alcohol or aldehyde-based agents such as Aerodesin 2000, Fugaten spray, Lysoformin 2000 or Aldasan 2000.• Vacuum the ventilation slots regularly.• Visually inspect the connections: make sure that the contacts for all connec-tions and cables are clean and free of any type of dirt.• To disinfect the patient cable and patient adapter, use a mixture of 70% isopro-panol and 30% water oder Lysoformin 3000: Allow it to take effect for 15 minutes at 2% concentration.Sterilization • The device cannot be sterilized.Test before each use • A short test of the device and the approved accessories should be performed prior to each use. This test consists of the following visual inspections and a simple functional tests:— Inspect the housing for mechanical damage, dents, loose parts, cracks, etc.— Inspect cables and connection areas to ensure proper insulation, no breaks, etc.— Inspect that the stylus is in place— Inspect the labeling for legibility— Inspect the displays (e.g. time and date)— Simple electrical function test: switch the device on; an internal function test will be conducted automatically— If no error message appears, then no errors were found and the device can be usedWARNINGExposure to fluids may result in fatal injuryBefore cleaning and disinfecting device surfaces: Pull the power plug!CAUTIONDanger of explosion if exposed to cleaning and disinfecting agentsLet cleaning and disinfection agents evaporate before operating the device.CAUTIONMay be damaged by cleaning agentsStrong and abrasive cleaning agents and other organic solvents, such as ether or benzine, corrode the surface of the device and must not be used.
16 Safety During UseInspection The inspection consists of the regular safety inspection according to medical device standards. This ensures the safety of the device. • The inspection must be performed— After using in conjunction with high-frequency surgical instruments or defibrillators— If malfunctions are suspected— Once a year• This inspection can be performed by BIOTRONIK.• The inspection should conform with the manufacturer specifications. These are available upon request. The specifications list all necessary test steps and the necessary equipment.Changing a fuse The fuses are located above the power cord port in a fuse holder. Disposal • This device contains materials that must be correctly disposed of in accordance with environmental protection regulations. The European Directive 2002/96/EC regarding waste electrical and electronic equipment (WEEE) applies.• The symbol on the label – a crossed out garbage can – indicates that the device must be disposed of in accordance with the WEEE directive. The black bar indi-cates that the device was sold after the national implementation of the WEEE directive was enforced in your country.• Return devices that are no longer used to BIOTRONIK.Disposal of cablesNon-contaminated cables must be disposed of in accordance with the European Directive 2002/96/EC regarding waste electrical and electronic equipment (WEEE).CAUTIONMains voltage - risk of death from electric shockBefore changing the fuses, switch off the device and disconnect the power cord.CAUTIONRisk of death from electric shock Defective fuses may indicate a technical defect in the device.Conduct an inspection after changing fuses and before resuming operation of the device (see Inspection, p. 16).Step Action1 To unlock the fuse holder, push the latches on the right and left inwards together.2 Pull the fuse holder out.3 Replace the old fuses with new ones of the same type (see Power cord port, p. 46).4 Re-insert the fuse holder and ensure that it locks securely in place.Note: Cables to be disposed of due to contact with blood must be disposed of as medical waste, in accordance with environmental regulations.
173StartupStartup3xxxxxx--XDoc-classRenamicDevice OverviewDevice in operating positionBild 1: Device operating element in working position, viewed from the front rightExplanation of items Explanation of the individual items: 71234568131211109Item Designation / description1 Screen (touchscreen)2 Device body3USB ports4ECG port5 Slot for expansion module6 Screen release button (right)7 Fixation for carrying strap (right)8 Pen holder
18 StartupDevice in transport positionBild 2: Device operating element in transport position, viewed from the front leftExplanation of items Explanation of the individual items: 9 PGH compartment lid release button10 Printer buttons11 Stylus in pen holder12 Safe program button13 Emergency shock buttonItem Designation / description141516181920Item Designation / description14 Carrying handle15 Fixation for carrying strap (left)16 Screen release button (left)18 Paper tray for internal printer19 On/off button20 Power cord port and device fuse
19 StartupPGH compartmentBild 3: Device operating elements, PGH compartment with lid open, viewed from above/in frontExplanation of items Explanation of the individual items: 21222324272625Item Designation / description21 PGH port22 USB slot for Bluetooth USB adapter23 PGH cable and ECG cable24 Cable feedthrough for PGH cable25 On/off LED26 Programming head (PGH)27 PGH compartment lid
20 StartupPower cord storagecompartmentBild 4: Device operating elements, power cord storage compartment with lid open, viewed from above/behindExplanation of items Explanation of the individual items: 28293130Item Designation / description28 Anti-slip stand29 Gripping tab30 Power cord in power cord storage compartment31 Power cord compartment lid
21 StartupTransportation and SetupTransporting the device • Renamic has an integrated ergonomic handle in the front and a gripping tab in the back, which can be used to safely transport the device in any position.• A carrying strap can also be attached to the device.• The specially designed anti-slip pads allow for horizontal or vertical positioning of the device.• When the device is slightly lifted (using the handle), the slick corners of the base allow for easy positioning on smooth surfaces (tables, shelves).• After setting the device down, the anti-slip pads keep the device securely in place.Setting up the device• Place the device on a flat dry surface. Make sure that it cannot shift even with the cable connected and that the patient can only come into contact with the applied parts, namely the programming head and ECG cable. The physician must not touch any connections such as USB ports or interfaces for modules or the programming head and the patient at the same time.Tilting the screen up • In transport position (screen closed), unlock the screen by pressing both release buttons at the same time. You can hear and feel the device unlock.• Hold the sides of the screen with both hands and tilt it up to the position you would like to use it in (1).• Pivot the screen around the upper end of the screen arm (2.). The operating position can be smoothly adjusted as needed.The screen will remain in any position due to its self-retaining bearings.WARNINGDanger to the user Danger of tripping over connected cables during device transport.• Prior to transporting the device, remove the attached cables and store them in the compartments intended for this purpose.WARNINGDanger to the patientThe device is not sterile and cannot be sterilized.• Do not set up the device in a sterile area and do not position the device so that the fan blows air into a sterile area.Note: The device can be operated in the patient's environment.
22 StartupThe two hinges of the screen arm allow for a wide range of working positions. Bild 5: Tilt radius of the screen and screen arm1.1.2.2.
23 StartupConnections and CablesBasic notes for cables andconnectionsConnect programming head The PGH port is located at the top right of the device inside the PGH compartment. Refer to figure PGH compartment, p. 19, item #21.• Pull the short end of the cable out of the PGH compartment and connect the PGH cable to the device PGH port.• Feed the PGH cable through the PGH compartment cable feedthrough. Refer to figure PGH compartment, p. 19, item #24.Connect ECG cableNote: Do not force the plugs into the ports. When disconnecting plugs, do not pull on the cable.Note: Only connect external devices that conform to DIN EN 60601 or DIN EN 60950 standards. Only then is the faultless functioning of the device guaranteed.CAUTIONAllergic reactions and inflammationsPrevent the cable and programming head from coming into contact with the patient's wounds or skin.Note: Since the device remains ready for operation in the transport position (screen flipped down and locked), the programming head can remain connected while the device is in this position.WARNINGDanger to patient by damaged cablesDamaged cables are limited in functionality and pose a danger to patients.• Do not use damaged cables.WARNINGDanger to the patientElectrostatic potential differences can cause currents that are dangerous to the patient.• Balance possible differences in electrostatic potential with the patient by touching the patient with your hand at a point a safe distance from the leads.
24 StartupRenamic can be used with the PK-222 ECG cable:Bild 6: ECG cable PK-222 with banana plugs for extremity leads (Einthoven)The ECG cable PK-222 has • Device: Redel plug, P series, 14-pole, 40°coded• Patient: 4 color-coded banana plugsWARNINGDanger to the patient or user from electrical currents in surface ECG leadsElectrical energy that flows into surface ECG leads can cause injuries to the skin or cause an arrhythmia.• The plugs of the ECG cables must not touch any conductive or grounded components, nor should they be inserted in electrical outlets or other connectors.• Attach all PK-222 plugs on the patient end securely to the patient.• Attach all unused plugs (e.g. if not all of the surface ECG connections are used) securely to the patient.WARNINGDanger to patient from allergic reactionsIf the cable comes into contact with open wounds, it can cause allergic reactions.• Prevent the cable from coming into contact with open wounds.WARNINGDanger from loss of functionDamp cables have limited functionality and pose a danger to patients.• Do not use damp cables.WARNINGDanger from electrical currentsUnused cable contacts can conduct electrical currents to patients.• Adhere unused cable contacts close to the patient.Note: The ECG port can be disconnected and reconnected while the device is still active.Note: The PK-222 ECG cable is provided unsterile and cannot be sterilized. Follow the instructions on cleaning and disinfecting in section Maintenance, Care and Disposal, p. 15.
25 StartupThe ECG port is located on the back right of the device. Bild 7: Position of the ECG port• Connect the ECG cable to the ECG port.Connection of USB devices The device's USB ports are intended for connection to various compatible devices, e.g. a USB flash memory stick, an adapter for an external monitor or an adapter for a serial interface.Note: Cables to be disposed of due to contact with blood must be disposed of as medical waste in accordance with environmental regulations.Note: Information regarding approved adhesive and clamp leads for surface ECG electrodes can be found in section Optional accessories (compatibility with third party suppliers), p. 50.Note: The USB flash drive used for data transfers must meet the Microsoft Blue-tooth Stack standard.Note: The USB port can be disconnected and reconnected while the device is still active.WARNINGDanger to the user when connecting non-conforming USB accessories. Leakage currents can cause injuries to the skin or cause an arrhythmia.• When using in combination with other devices, do not use portable multiple socket outlets, but connect all devices to fixed outlets in the same electrical circuit used for medical purposes.
26 StartupThere are three USB ports located on the back right of the device and one in the PGH compartment (recommended USB port for the Bluetooth adapter). Bild 8: Position of the USB ports• Connect the USB device or USB cable to the USB port.CAUTIONRisk of exceeding the leakage currents when connecting external devices with their own power supply or an electrically conductive connection to other devices.• Only connect devices that comply with the applicable ISO, EN or IEC standards such as IEC 60601-1 or IEC 60950.• Place devices that do not adhere to the IEC 60601-1 standard at least 1.5 m away from the patient.• Before initial commissioning, check and document all device combinations according to IEC 60601-1 paragraph 16.6 for observance of leakage currents.You do not have to perform this inspection if the USB device is supplied via bus, which means it does not have its own power supply and has no electri-cally conductive connection to other devices or if it is connected to Renamic's USB port via an isolating separator (IEC 60601-1 paragraph 16.5) with a dialectric strength of at least 1.5 kV (e.g. isolating USB hub model UISOHUB4 made by B&B electronics).• Perform this inspection at least once per year according to the legal require-ments.• Ensure that the leakage currents do not exceed the following maximum values when operating the device within the patient environment:• Housing leakage currentNormal condition: 0.1 mASingle fault condition: 1.5 mA• Ground leakage currentNormal condition: 0.5 mASingle fault condition: 1.0 mA• Patient leakage currentNormal condition: 0.01 mA= / 0.1 mA ˜Single fault condition: 0.05 mA= / 0.5 mA ˜• Patient auxiliary currentNormal condition: 0.01 mA= / 0.1 mA ˜Single fault condition: 0.05 mA= / 0.5 mA ˜
27 StartupEquipping the device with aBluetooth adapterIf you equip the device with a Bluetooth adapter, various Bluetooth compatible devices can communicate wirelessly with the programmer. BIOTRONIK supplies a compatible Bluetooth adapter with the programmer. • Before using the Bluetooth adapter, ensure that it is authorized for Bluetooth radio communication in your respective country / region. The recommended port for this Bluetooth adapter is located in the PGH compart-ment on the right hand side of the device underneath the protective cap. Refer to figure PGH compartment, p. 19, item #22.We recommend connecting the Bluetooth adapter while the device is turned off. • Open the PGH compartment and remove the protective cap from the port for the Bluetooth adapter.• Connect the Bluetooth adapter to the USB port.• Replace the protective cap over the Bluetooth adapter.
28 StartupPower SupplyPower supply The device is operated via the AC voltage of a room used for medical purposes: • 100 – 115 V 10% / 60 Hz / 1.2 A / AC• 220 – 230 V 10% / 50 Hz / 0.6 A / ACConnecting the power cordto the deviceThe connection for the power supply is located on the back of the device on the left. Bild 9: Position of the power cord port• Connect the provided power cord to the device's power cord port and then to a suitable power outlet.
29 StartupSwitching On and OffSwitching the device on The on/off button is located on the back left of the device. Bild 10: The on/off button is positioned next to the power cord port.• To switch the device on, press the on/off button once on the pressure point.• The on/off LED on the front left of the device lights up.For the position of the on/off LED: refer toPGH compartment, p. 19, item #25.Startup of the operatingsystemAfter switching the device on, the operating system will boot.During this time, the device cannot be operated.Meanwhile, the start screen will also load.Ready-for-service status,start screenAfter successful booting of the operating system, the screen displays the complete start screen which indicates the device's ready-for-service status.Depending on whether a programming head is connected, the device has telemetry contact to an active implanted device and/or which other ports are occupied, then the start screen may display additional details. Bild 11: Start screen after successful booting of the operating system•Check all displays and signals at all times for correct functionality. If a display does not function correctly, then look for the cause. If necessary, switch the device off and then on again.Note: The device can be switched on in both the working position (screen open) and in the transport positions (closed).The on/off LED is visible in both positions.
30 StartupSwitching the device off • To switch the device off, press the on/off button once on the pressure point or shut the device down using the software user interface.CAUTIONDanger to data integritySudden disconnection from the power source can lead to the corruption of data• Only use the on/off button of the software user interface menu to switch the device off.Note: The device does not switch off if you close the screen.Therefore, the device can be left in operating mode and put aside temporarily to save space. Pay attention to the connected cables.By reopening the screen, the programmer is immediately functional again.
314 Using RenamicUsing Renamic4xxxxxx--XDoc-classRenamicKeys, Displays and SignalsKeys on the device The device has several keys to which fixed functions are assigned.Overview of the device keys: • With the exception of the function for delivering an emergency shock, the respective function is activated by pressing the key once on the pressure point.Position of the keys The emergency keys are located on the front of the screen on the lower left. Bild 1: Location of the emergency keysDesignation Description1 Emergency keys • Safe program key to switch on the safe program of the implanted device (emergency pacing). The safe program comes into effect immedi-ately (see: Emergency Programs, p. 33)• Emergency shock key to trigger emergency shock via the ICD. The emergency shock is delivered in 2 controlled steps (see: Emergency Programs, p. 33)2 Printer keys Keys for controlling the internal printer (see: Using the Internal Printer, p. 39)3 On/off key Key for switching the device on and off (see: Switching On and Off, p. 29)
32 Using RenamicThe printer keys are located on the left side of the PGH compartment lid. Bild 2: Location of the printer keysOn/off light indicator The on/off light indicator shows whether the device is switched on (lit) or off (not lit).It is located on the front left edge of the device. Refer to figure PGH compartment, p. 19, item #25.Screen The device screen is a touch screen that is operated using a stylus or finger. The following is displayed on the screen:• Parameters and measured values• ECG, IEGM and marker channel• ButtonsButtons on the screen The individual functions can be selected using the software interface buttons on the screen. These buttons respond to touch or light pressure from the stylus or finger similarly to keys.Signal beep The device issues a sound when you press a key or button.You can use the software program to switch off key and button sounds.
33 Using RenamicEmergency ProgramsQUICK REFERENCE GUIDEFOR EMERGENCIESSAFE PROGRAM (EMERGENCY PACING): DELIVER EMERGENCY SHOCK: Purpose of the emergencybuttonsThe emergency buttons are used for the following: • They implement the parameters of the safe program (emergency pacing) by pressing a single button.• They start emergency pacing or emergency shock.Condition The programming head creates telemetry contact between Renamic and the active implanted device.Sequence When the emergency buttons are activated, the following will occur: • The current active programming in the implanted device will be deactivated.• The corresponding emergency parameter values will be activated and the selected emergency program will start.Step Action1 Position the PGH above the implanted device so that telemetry contact is created.2 Press the safe program button:Step Action1 Position the PGH above the ICD so that telemetry contact is created.2 Press the emergency shock button:3 In the dialog window, select [EMERGENCY SHOCK].WARNINGDanger to the patient from high electrical energiesHigh levels of electrical energy are conducted to the patient through the emer-gency programs.• Only activate the safe program or emergency shock under the supervision of a physician.
34 Using RenamicLocation of the emergencybuttonsBild 3: Location of the emergency buttons on the deviceStart emergency pacing Proceed as follows: Stop emergency pacing Proceed as follows: Trigger emergency shock Proceed as follows: Step Action1 Position the PGH above the implanted device so that telemetry contact is created.2 Press the safe program button:Step Action1 Activate the desired permanent parameters in the program of the implanted device and transfer them to the implanted device.Step Action Result1 Position the PGH above the ICD so that telemetry contact is created.Telemetry contact is created between the ICD and the Renamic programmer. 2 Press the emergency shock button:• The emergency shock parameters are activated.• As a safety precaution, a dialog window will give you the option to cancel this action.3 In the dialog window, select [EMERGENCY SHOCK].• The ICD shock capacitors are charged.• Renamic triggers a 30 or 36 J emer-gency shock via the ICD.
35 Using Renamic Parameter values Tabelle 1: Safe program default parameter valuesTabelle 2: Emergency shock default parameter valuesParameter ValueMode VVIBasic rate 70 ppmPulse amplitude 7.5 VPulse width 1.5 msParameter ValueShock waveform BiphasicType DF (defibrillation shock)Energy • 30 J• Implanted device with high engergy: 36 J
36 Using RenamicProgramming HeadBild 4: Programming head (PGH) with connection cablePrerequisites • Connect the programming head to the Renamic programmer before you turn on the device (see: Connect programming head, p. 23).• If you are using the programming head under sterile conditions, cover the programming head with a sterile cover (see: Scope of Delivery and Accessories, p. 49).Telemetry: Principle Communication between the programmer and the implanted device takes place through telemetry via the programming head (PGH). The output data from the implanted device (digital and analog) are converted into digitally coded pulses and transmitted over an inductive coupling between the coils of the programming head and those of the implanted device. With some implanted devices, telemetry cannot be carried out until a reed switch in the implanted device has been closed. For this purpose, a strong permanent magnet has been integrated into the programming head. Before the programming head and the implanted device can exchange data, the reed switch in the implanted device is closed. When the reed switch is open, telemetry is blocked. This protects the implanted device from unintentional reprogramming. With some implanted devices, closing the reed switch also switches the device over to an asynchronous pacing program (see the technical manual of the respective implanted device). CAUTIONRisk to magnetically sensitive objectsThe programming head contains a strong magnet. • Do not place the programming head close to magnetically sensitive objects such as magnetic data media, credit cards or wristwatches.
37 Using RenamicEstablishing telemetry Each programming head features arrows to assist in positioning the head. Silicone tines on the underside prevent the head from slipping.Bild 5: Position indicator for the programming head• Place the programming head on the patient above the active implanted device so that the arrows are pointing toward the patient's head.Tabelle 3: Status display for telemetry contactThe LED at the front of the programming head indicates the telemetry contact to the implanted device: Using the safe program The programming head is equipped with its own safe program button. Bild 6: Key for the safe program on the programming headThis function can be started immediately from any application if the programming head is positioned above the implanted device.LED status (flashing) Telemetry statusGreen Telemetry contact optimalOrange Telemetry contact in limit rangeRed Telemetry contact disturbedOff No telemetry contactWARNINGDanger to the patient from high electrical energiesHigh levels of electrical energy are conducted to the patient by the emergency program.• Only activate the safe program or emergency shock under the supervision of a physician.
38 Using RenamicCommunication with Active Implanted DevicesSoftware The interaction/communication between the Renamic programmer and active implanted devices is controlled using software specific to each implanted device. • The software is installed on the Renamic device drive by BIOTRONIK employees.• Software can only be updated on site by BIOTRONIK employees or by those authorized by BIOTRONIK.Interrogating and program-ming the implanted deviceBIOTRONIK implanted devices can communicate with Renamic in both directions via the programming head. As soon as the programming head is correctly posi-tioned over the implanted device, the program data and all data stored in the implanted device can be transmitted to the Renamic programmer. Depending on the implanted device, a large number of adjustable parameter sets are available. These parameter sets are combined and saved in the program that is currently active. The Renamic programmer can detect obvious programming errors and requires that these errors be corrected before the program is trans-ferred to the implanted device. The following programs can be transmitted: • Permanent program• Temporary program•Safe programA temporary program is a program that the pacemaker uses to provide temporary pacing as long as the programming head is in position.A permanent program is a program that is programmed in the pacemaker using the programming head and which performs pacing permanently without telemetry contact to the programming head.A safe program is a device-specific program used for safety pacing with high energy in either VVI or SSI mode.Data transfer The follow-up data can be saved, sorted and/or exported as follows: • Connect an external PC system for data processing (e.g., CDM 3000)• Connect an external printer for printing out all data, with the exception of real-time ECGs• Connect a USB flash driveReports Internal printer for printing out the complete documentation: • All follow-up reports such as program and test data as well as saved data• All real-time ECGs, ECGs, IEGMs, event markersNote: Use of a temporary program can be stopped at any time and the permanent program of the implanted device can be automatically reactivated with the following:• Removing the programming headOr:• Switching off the programmer.
39 Using RenamicUsing the Internal PrinterThe Renamic programmer has a high definition thermal printer that is capable of printing graphics. The device prints on thermal folding paper. See: Scope of Delivery, p. 49 Bild 7: Paper tray: position on the deviceInserting paper Proceed as follows: Note: The thermal paper printouts are moisture-sensitive and fade when exposed to strong sunlight. Make copies for permanent documentation.CAUTIONPrintouts that cannot be used or cause damage to the printerThe use of paper not intended for this device can lower the quality of the printout or cause damage to the device. • Use paper specified by BIOTRONIK at all times. See: Scope of Delivery, p. 49.Step Action1 To open the paper tray: • Open the lid by lightly pushing it up. • Pull the tray out until it stops.• In order to remove the tray from the device, press the lever down on the right side.
40 Using Renamic2 To insert paper: • Press back the separating flap. • Pull back the first page of the paper block. • Place the block of paper in the tray from above so that the wide marking of the paper block is on the left side.• Place the separating flap under the first sheet of paper.• Pull the first page over the separating flap and rubber roller.3 To close the paper tray: • Push the tray back into the device until it stops.If there is too much paper in the tray and it is difficult to push it back into the device, then tear off enough paper and repeat the steps.• The cover locks automatically. Note: The printer is ready for operation only when the paper tray has been inserted and closed.Step Action
41 Using RenamicPrint The printer buttons are located on the left front side. Bild 8: Printer buttonsKey assignment from left to right: • You can use the numbered keys to switch on the printer with the respective printing speed in mm/s.• Use the stop key to quit printing.• The feed button is used to move the paper to the beginning of the next page. The feed mechanism automatically advances the paper to the next tear-off edge.
42 Using RenamicUsing an External PrinterPrerequisites You can connect an external printer to Renamic under the following electrical safety conditions: • With the exception of the wireless connection, after the system has been installed in the hospital, compliance with the leakage current limit values according to IEC 60601-1, paragraph 16.6 must be demonstrated.• The printer must be set up outside the patient environment (at least 1.5 meters away from the patient). You can use any printer that supports the PCL5 printer language and is compatible with a generic HP driver.Configurations In order to ensure electrical safety, it is only permissible to connect an external printer if one of the following conditions is met for the connection between the printer and Renamic: • The printer is Bluetooth-compatible. The connection to Renamic is established using the accessory Bluetooth adapter (See Equipping the device with a Blue-tooth adapter, p. 27).• The printer is powered via the mains supply and is connected to the USB port of Renamic via an isolating separator (IEC 60601-1, Paragraph 16.5) with a dielec-tric strength of at least 1.5 kV (e.g. an isolating USB hub model UISOHUB4 by B&B electronics).• The printer is supplied directly from the mains by a medical device power supply. Connect it to the USB port of Renamic.
43 Using RenamicECG and IEGM FunctionsConnecting the ECG cable See section: Connect ECG cable, p. 23ECG recorder and ECGmonitorAll ECGs can be displayed in real time in the recorder or trigger mode and printed on the internal printer.ECG leads Tabelle 4: Accessories for ECG leadsSee also: Accessories, p. 49 Recording ECGs and IEGMs The intracardiac electrograms received from the implanted device and the surface ECG can be displayed and printed simultaneously. The recording of the surface ECG is independent of other functions, so that the implanted device can be interrogated and programmed during the ongoing ECG display. The recorded electrograms can be saved and measured using electronic calipers.Overmodulated ECG input When the ECG input is overmodulated, the signal is displayed only as a solid line on the upper frame of the ECG window. Proceed as follows to fix overmodulation: Lead Patient DeviceUp to 3 leads (Einthoven) Permitted adhesive and clamp leadsPK-222 Note: Follow the instructions for connecting the ECG cable PK-222 in section Connect ECG cable, p. 23.Note: It is not permitted to use the device's ECG display for diagnostic purposes because it does not meet all requirements for diagnostic ECG devices (IEC 60601-2-25).Step Description1 Test the lead contacts.2 Remove other devices from the patient.3 Turn off the sources of interference.
44 Using Renamic
455 AppendixAppendix5xxxxxx--XDoc-classRenamicTechnical DataPhysical characteristicsGeneral classificationLongevityAmbient conditionsTouch screenCategory DesignDimensions (W x D x H) 345 x 476 x 125 mmWeight with cables and programming head10,5 kg  10%Housing material PC/ABSCategory DesignClassification AIMD according to directive 90/385/EECSafety class IProtection rating IP 30Operating mode Continuous operationCategory DesignLongevity 6 yearsCategory DesignTemperature range for operation +10°C ... +40°CTemperature range for storage 0°C ... +50°CRelative humidity 30% ... 75%, no condensationAtmospheric pressure 700 ... 1060 hPaOperation at altitudes Up to 3000 mCategory DesignSize 12.1'Tilt 35 – 80 °Resolution 800 x 600 SVGAContrast Ratio (CR) 200:1Brightness At least 150 cd/m
46 AppendixECG moduleProgramming headPower cord portMass storageCategory DesignApplied part classification BF, defribrillation-proof with PK-222Leads 3 (Einthoven)A/D converter 12 bitsScan rate 500 ... 1000 HzInterface Redel plug, 14-poleCategory DesignApplied part classification BFDimensions (W x D x H) 145 x 42 x 97 mmWeight 0.3 kgPGH cable 2.9 mProtection rating IP 30Magnetic flux density Max. 3 mTInterface Redel plug, 14-poleCategory DesignSupply voltage 100 – 115 V, 10% / 60 Hz / 1.2 A / AC 220 – 230 V, 10% / 50 Hz / 0.6 A / AC Safety class IFuse type 3.15 A; T; 250 V (G fuse IEC 60127 5 x 20 mm)Max. power input Duration 100 WPeak 150 WEfficiency  75%(at 230 V/50 Hz)On/off LED Green LED, lit continuouslyCategory DesignType Hard diskShock resistance Min. 175 G (operating)Min. 700 G (non-operating)Storage capacity Min. 40 GBMagnetic field resistance 50 mT
47 AppendixInternal printerMICSGSM moduleUMTS moduleCategory DesignType Thermal printerPrinting width 4'Resolution 8 Dots/mmPaper Z-foldPaper format (B x L) 112 x 125 mmPaper supply 200 + 10 sheetsCategory DesignRate band 9 channels 402 – 405 MhzRange 300 kHzStandard channel 403.65 MHzModulation FSKEncoding ManchesterData rate 32768, 16384, 8192, 4096, 2048 bit/s (unencoded)Category DesignModel GSM/GPRS quadband MotorolaType G24L bzw. G24GSM rate 850 MHz, 900 MHz, 1800 MHz, 1900 MHzTransmission power 2 W: 850/900 MHz1 W: 1800/1900 MHzGPRS Multislot class 10(4 Down, 2 Up)Category DesignModel Motorola, 4 band GSM +3 band UMTSType H24UMTS rate 850 MHz, 1900 MHz, 2100 MHzGSM rate 850 MHz, 900 MHz, 1800 MHz, 1900 MHzUMTS transmission power 0,25 WGSM transmission power 2 W: 850/900 MHz1 W: 1800/1900 MHzUMTS Max. Range:Uplink: 5.76 MbpsDownlink: 7.2 MbpsUE CAT [1-8], 11, 12 supportedCompressed mode (3GPP TS25.212)GSM Multi-slot class 12(4 down, 4 up, 4 total)Coding scheme: CS1–CS4
48 AppendixWLAN moduleCategory DesignTransmitter rate Europe: 2,412 GHz bis 2,472 GHzUSA: 2,412 GHz bis 2,462 GHzMax. transmission power 100 mWProtocols WEP, WPA, WPA2, HTTPSStandards IEEE 802.11bIEEE 802.11gChannels Europe: 13 channelsUSA: 11 channels
49 AppendixScope of Delivery and AccessoriesScope of Delivery Renamic (Order no.: 371960) AccessoriesItem designation Amount Order no.Renamic (single device) WLAN module* Customer-specific 379173GSM module* Customer-specific 379174UMTS module* Customer-specific 379366Without module Customer-specific 365533Programming head 1 371588Power cord 1 Country-specificPK-222-EU / 2.8 m or PK-222-US / 2.8 m 1 Country-specificBluetooth USB adapter 1 367929Stylus 1 371586Thermal printer paper 2 348728PK Electrode Clip 1 340293Multilingual technical manual (de, en, es, fr, it) 1 377213Technical manual ZH (printed) Country-specific 370975Quick reference guide DE (printed) Country-specific 370976Quick reference guide EN (printed) Country-specific 370977Quick reference guide ES (printed) Country-specific 370978Quick reference guide FR (printed) Country-specific 370979Quick reference guide IT (printed) Country-specific 370980Quick reference guide ZH (printed) Country-specific 370981*Not available in all countriesItem designation Description Order no.PK-222-EU / 2.8 m ECG cable with banana plug for extremity leads according to Einthoven335284PK-222-US / 2.8 m Same as the PK-222-EU with country-specific color coding of the banana plugs335281PGH ICD Programming head without magnet with straight cable (2.9 m)371589NK-3 Power cord EU 107526NK-11 (3 m) Power cord US 128865NK-16-GB (2 m) Power cord for the United Kingdom 330705NK-19-CN (2.5 m) Power cord for Canada 339034NK-21-AU,UY (2.5 m) Power cord for Australia and Uruguay 339035NK-22-AR (2.5 m) Power cord for Argentina 339039NK-26-CL, IT (2.5 m) Power cord for Chile and Italy 339043NK-28-DK (2.5 m) Power cord for Denmark 339059NK-25-CH (2.5 m) Power cord for Switzerland 339042
50 AppendixOptional accessories(compatibility with thirdparty suppliers)NK-27-IL (2.5 m) Power cord for Israel 339044NK-33-BR (2.5 m) Power cord for Brazil 378933Memory stick (compatible with Renamic)USB flash memory stick for connection to the USB inter-face of the programmer; e.g. for data export350017USB adapter for serial interface Virtual serial interface via USB 376437USB adapter for VGA port Virtual VGA interface via USB 377292Sterile cover 1 Sterile cover for single use on programming head (cannot be re-sterilized)118022M 50 Permanent magnet; magnetic flux density: 12.5 min. in mT; dimensions (W x H x D): 60 x 17 x 26; weight: 0.185 kg (0.408 lb)112149Shoulder strap Carrying strap that can be fixed to the Renamic hangers. 371962Protective cover Protective cover for Renamic 376999Item designation Description Order no.Item designation Manufacturer DescriptionH34 SG Kendall ARBO Adhesive electrodesT 60 SKINTACT Adhesive electrodesType 454 Dahlhausen Adhesive electrodesType 460 Dahlhausen Adhesive electrodesG502 GOLMED Clamp leadCruzer Micro SanDisk USB flash memory stickUSB 2.0 to DVI - VGA - HDMI adapter (61644)DeLOCK Visual VGA interface via USBUSB 2.0 to Serial (61425) DeLOCK Virtual serial interface via USBG84-4400LUBDE-0 Cherry Keyboard via USBMouse Dell Maus via USBPassport II; 2.5'; 5400 RPM, 320 GB (WDXMS3200TE)Western Digital External hard drive via USB
51 AppendixElectromagnetic Compatibility in Compliance with EN 60601-1-2:2007• As the user, you must ensure that the device is operated in a suitable electro-magnetic environment. • The following guidelines may not be applicable in all cases. The propagation of electromagnetic values is, for example, affected by the absorption and reflec-tion of structures, objects and people. This data is for your personal informa-tion.Electromagnetic Emissions(Table 1)Recommended safetydistances (Table 6)• Safety distances help prevent interference if you maintain a minimum distance between transmitters such as mobile RF telecommunication devices and the Renamic programmer. The necessary distance depends on the respective power output of the transmitter.• For transmitters whose maximum output power is not indicated in the table, the recommended safety distance [d] can be calculated in meters using an equation that is suitable for the respective transmission frequency range. P is the Devices with the warning sign “Beware of non-ionizing radiation” must not be operated in the environment of the device due to poten-tial interferences.Measuring the emitted inter-ference Compliance Guidelines for the electromagnetic environmentRF interference according to CISPR 11Group 1 The device uses RF energy exclusively for its own function. Therefore, the RF interference emitted is very low and not likely to cause any interference in nearby electronic equip-ment.RF interference according to CISPR 11Class B The device is suitable for use in all establishments. This includes residences and facilities directly connected to the public power supply network that supplies buildings used for domestic purposes.Interference of harmonic oscil-lations according to IEC 61000-3-2Class AEmitted interference of voltage fluctuations according to IEC 61000-3-3CompliesNote: At 80 MHz and at 800 MHz, the higher frequency range applies.Transmission frequency 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHzMaximum output power of the transmitter [W]Safety distance [m] 0.01 0.12 0.12 0.240.1 0.37 0.37 0.741 1.17 1.17 2.3410 3.70 3.70 7.40100 11.7 11.7 23.4
52 Appendixmaximum output power of the transmitter in watts [W] according to the specifi-cation of the transmitter's manufacturer.Resistance to electromag-netic interference(tables 2 and 4)• When the measured field strength exceeds the specified compliance level at the operating location of the Renamic device, observe the device in order to deter-mine whether it is functioning properly.• If abnormal performance is observed, change the orientation or the location of the device. In the frequency range of 150 kHz to 80 MHz, ensure that field strengths are lower than 3 V/m.Transmission frequency 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHzEquation d = 1.17 P d = 1.17 P d = 2.34 PNote: UT is the mains alternating voltage before applying the test levels.Test of resistance to interfer-ence Test level according to IEC 60601-1-2 Compliance Guidelines for the electromagnetic environmentElectrostatic discharge (ESD) according to IEC 61000-4-26 kV contact discharge8 kV air dischargeSame as test level• Operate the devices on floors made of wood, concrete, or ceramic tile. If the floor is covered with synthetic material, the relative humidity must be at least 30%.Fast transient electric interfer-ences (bursts) according to IEC 61000-4-42 kV for power supply lines1 kV for input and output linesSame as test level• Ensure that the power supply quality is that of a typical commer-cial and/or hospital environment.Surges according to IEC 61000-4-51kV push-pull voltage2 kV for common-mode voltageVoltage drops, brief interrup-tions and fluctuations in the supply voltage according to IEC 61000-4-15% UT for 1/2 cycle 95% drop40% UT for 5 cycles 60% drop70% UT for 25 cycles 30% drop5% UT for 5 s 95% dropSame as test level• Ensure that the power supply quality is that of a typical commer-cial and/or hospital environment. • If you require continued operation during power supply interruptions, connect the device to an uninter-ruptible power supply or use a battery for operation.Magnetic field at the supply frequencies (50/60 Hz) according to IEC 61000-4-83A/m Same as test level• Ensure that the magnetic field strengths are at levels character-istic of a location in a typical commercial and/or hospital envi-ronment.Note: At 80 MHz and at 800 MHz, the higher frequency range applies.
53 AppendixTest of resistance to interfer-ence Test level according to IEC 60601-1-2 Compliance Guidelines for the electromagnetic environmentConducted RF interferences according to IEC 61000-4-63Veff 3 V • Maintain safety distance of mobile radio equipment to the Renamic programmer; see table 6.• The field strength of stationary transmitting devices must be measured on site and must be lower than the compliance level at all frequencies: consider conducting a study of the site.• The field strength must be lower than 3 V/m over the frequency range of 150 kHz to 80 MHz.Radiated RF interferences according to IEC 61000-4-33 V/m 80 MHz to 2.5 GHz3V/m
54 AppendixCountry-Related InformationUL certification Renamic (Order no.: 371960) has been certified by Underwriters Laboratories Inc. in accordance with UL 2601-1 and CAN/CSAC22.2 No. 601.1-M90.UL-certified devices are identified as follows:Distribution in the US andCanadaIn the US and Canada, the device must be connected to a center-tapped power outlet if the voltage network carries 230 V at 60 Hz.Identifications Industry Canada: • Renamic: 4708A-RENAMIC• Programming head: 4708A-ICSPGHThe code IC in front of the approval/registration number indicates that the tech-nical requirements for Industry Canada are met.Federal Communication Commission of the USA: • Renamic: QRIRENAMIC• Programming head: QRIICSPGHModifications which are not expressly approved by this company may void the rights to operate the devices.FCC RF exposurerequirementsYour device is equipped with a radio frequency (RF) transceiver for wireless communications. These communication are transmitted via an RF assigned by the Federal Communications Commission's (FCC) for Medical Implant Communica-tions Service (MICS).This device may not interfere with stations operating in the 400.150–406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interfer-ence that may cause undesired operation. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
55 AppendixSymbols on the ComponentsSymbols on the right side ofthe deviceThe symbols mean the following: Symbols on the left side ofthe deviceThe symbols mean the following: Symbols on the monitor The symbols mean the following: Symbols on the PGHcompartmentThe symbols mean the following: ECG port with applied part classification BF, defibril-lation-proofUSB portsBinary interface (slot for expansion module)Follow the instructions in the technical manual!On/off buttonFuseFollow the instructions in the technical manual!Caution!Emergency shock buttonSafe program buttonKey for setting printer speed to 10 mm/s10
56 AppendixSymbols in the PGHcompartmentThe symbols mean the following: Symbols on the program-ming headThe symbols mean the following: Key for setting printer speed to 25 mm/sKey for setting printer speed to 50 mm/sKey used to stop printingFeed button to feed the paper to the beginning of the next page2550Programming head connection with applied part classification BFUSB portPosition and connection of the programming head and position of the ECG cableFollow the instructions in the technical manual!Symbol for the safe program keyPosition indicator for the programming head
57 AppendixLegend for the LabelThe label icons symbolize the following: Manufacturing dateBIOTRONIK order numberSerial numberAcceptable temperature ranges for storageAcceptable atmospheric pressure range for storageAcceptable relative humidity range for storageNon-sterileFollow the instructions in the technical manual!ContentsDo not use if package is damaged!European approval markCountry-specific restrictions concerning the circula-tion and implementation of the deviceCaution: Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physicianNONSTERILE
58 AppendixDevice contains materials that must be correctly disposed of in accordance with environmental protection regulations.European Directive 2002/96/EC regarding waste electrical and electronic equipment (WEEE) applies. Return devices that are no longer used to BIOTRONIK.Programmer (Renamic) for electrotherapy implanted devicesCable and adapterProgramming headWarning: Magnetic field
596 DirectoriesDirectories6xxxxxx--XDoc-classRenamicList of KeywordsCCharacteristics, 45Cleaning, 15Connect external devicesECG cable, 23Programming head, 23Connection of external devicesBluetooth adapter, 26USB devices, 25Connection of external devices, external printer, 42DDamage, 12Defibrillation, 11Device buttonEmergency pacing, 33Emergency shock, 33Disinfecting, 15Disposal, 16Disposal of cables, 16EECG, 43Electromagnetic compatibility, 51Electromagnetic emissions, 51Electromagnetic interference, 14Test, 14Electrostatic potentials, 10EmergencyEquipment, 10Emergency pacing, 33Emergency shock, 33Parameter values, 35Expertise, required, 8IIEGM, 43Installation site, 12Intended use, medical, 7MMaintenance, 15Maintenance, inspection, 15Maintenance, test before each use, 15
60 DirectoriesPPatient environment, 12Power Supply, 28Printerexternal, 42internal, 39Programming head, 36RRecommended safety distances, 51Resistance to electromagnetic interference, 52Risks, 9SSafe programKey on the programming head, 37Parameter values, 35Safety instructions, summary, 10Scope of delivery and accessories, 49Software, 38Sterilization, 15TTechnical data, 45Ambient conditions, 45ECG module, 46General classification, 45, 47, 48Internal printer, 47Longevity, 45Mass storage, 46Physical characteristics, 45Power cord port, 46Programming head, 46Touch screen, 45Technical manual, 6TelemetryPrinciple, 36Status display for contact, 37Transport damages, 12UUse with other devices, 13

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