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
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| Document ID | 1365092 |
| Application ID | 3m45sFQ7GTqZ1wg2M03Veg== |
| Document Description | QRIRENAMIC_UserMan |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 86.51kB (1081343 bits) |
| Date Submitted | 2010-10-25 00:00:00 |
| Date Available | 2010-10-25 00:00:00 |
| Creation Date | 2010-10-12 11:27:31 |
| Producing Software | Acrobat Distiller 9.0.0 (Windows) |
| Document Lastmod | 2010-10-13 08:28:19 |
| Document Title | Renamic.book |
| Document Creator | FrameMaker 7.2 |
| Document Author: | gutschlich_f1 |
3 Table of Contents Table of Contents Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 About the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 About this Technical Manual. . . . . . . . . . . . . . . . . . . . . . . . . . 6 Safety During Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Required Expertise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Residual Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . 10 Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Electromagnetic Interference. . . . . . . . . . . . . . . . . . . . . . . . 14 Maintenance, Care and Disposal . . . . . . . . . . . . . . . . . . . . . 15 Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Device Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Transportation and Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Connections and Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Switching On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Using Renamic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Keys, Displays and Signals . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Emergency Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Programming Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Communication with Active Implanted Devices . . . . . . . . . 38 Using the Internal Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Using an External Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 ECG and IEGM Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Scope of Delivery and Accessories. . . . . . . . . . . . . . . . . . . . 49 Electromagnetic Compatibility in Compliance with EN 60601-1-2:2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Country-Related Information . . . . . . . . . . . . . . . . . . . . . . . . 54 Symbols on the Components . . . . . . . . . . . . . . . . . . . . . . . . 55 Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Directories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 List of Keywords. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 377213--D 4 Table of Contents 5 Introduction Introduction1xxxxxx--XDoc-classRenamic About the Device General 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 Purpose Programming and testing functions Program BIOTRONIK pacemakers and ICDs during the implantation procedure or follow-ups ECG recorder and ECG monitor Display and printout of up to three leads of surface ECGs, as well as up to three intracardiac derivations (IEGMs) and the corresponding event markers, in real-time Data management Store parameter values and ECG/IEGM recordings for computer-aided archiving and evaluation Documentation Print out follow-up reports using the internal and/ or external printer 6 Introduction About this Technical Manual Objective 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: Target group • Device startup • Interrogation, testing and programming of implantable pulse generators and cardioverter-defibrillators (ICD) 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 systems Additional 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 devices Other technical manuals • Technical software manual for programming the intended implantable pulse generator / ICD • Technical manual for the intended implantable pulse generator / ICD 7 Safety During Use Safety During Use2xxxxxx--XDoc-classRenamic Intended Medical Use Intended 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 8 Safety During Use Required Expertise Required 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 electrotherapy can properly operate the device. German medical device ordinance This 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 accessories 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.' 9 Safety During Use Residual Risk Risk 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 Use General Safety Instructions Technical manual Risks of improper handling Only use the programmer in accordance with this technical manual. Disregarding the safety instructions can endanger the patient, the staff and the equipment. Note: Failure to observe the safety precautions voids all damage claims and manufacturer liability. The following dangers may arise in the event of improper use: • Failure of important device functions • Personal endangerment due to electrical effects Changes not permitted Only the manufacturer or a party expressly authorized by BIOTRONIK may perform corrective maintenance, enhancements or modifications to the device. Replacement parts and accessories To 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 Physician supervision Patient observation Emergency equipment Do not use defective or damaged devices. 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. Ensure that patients are individually observed over a suitable period of time in order to monitor the compatibility and effectiveness of parameter combinations. Always ensure that in the event of an emergency the following basic equipment is available: • Defibrillator • Intubation set • Oxygen • Emergency drugs For pacemaker-dependent patients, an additional external pacemaker must also be available. Life support system Liquids Electrostatic potentials Do not use this device as a life support system. • Never use a damp or wet device. • Protect the device from the accidental ingression of fluids (e.g. infusion fluids). 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. 11 External ECG device Defibrillation Safety During Use During the implantation procedure, the patient's heart rate should be additionally monitored using an ECG monitor or ECG recorder. • 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 Use Operating Conditions Storage and transportation • If the packaging is damaged, please contact BIOTRONIK immediately. Do not put the device into operation. CAUTION Functional impairment due to external damage Mechanical impact, for example dropping the unit - even from a height of over 5 cm if unpackaged - can permanently impair the function of the system. Installation site • Do not use the device if it shows visible damage. • Contact BIOTRONIK for testing and, if necessary, repair of the equipment. 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 connection Place 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 Cable and plug connections Patient environment 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 60364-7710:2002 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. • 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. This device may be used in the patient environment. 13 Safety During Use Place 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 Start parameters and default settings The device may not be used on the patient in conjunction with high frequency surgical equipment. Once 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 Use Electromagnetic Interference Possible electromagnetic interference The 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 – electrical 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. 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. 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 electromagnetic interference can be located and then turned off. 15 Safety During Use Maintenance, Care and Disposal The following regulations are valid for the device. WARNING Exposure to fluids may result in fatal injury Before cleaning and disinfecting device surfaces: Pull the power plug! CAUTION Danger of explosion if exposed to cleaning and disinfecting agents Let cleaning and disinfection agents evaporate before operating the device. CAUTION May be damaged by cleaning agents Strong and abrasive cleaning agents and other organic solvents, such as ether or benzine, corrode the surface of the device and must not be used. Cleaning and disinfecting • Use lint-free, soft cloths. • Clean the housing with a damp cloth and mild soap solution or 70% isopropanol. 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 connections and cables are clean and free of any type of dirt. • To disinfect the patient cable and patient adapter, use a mixture of 70% isopropanol 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 used 16 Inspection Safety During Use 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 Changing a fuse • 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. The fuses are located above the power cord port in a fuse holder. CAUTION Mains voltage - risk of death from electric shock Before changing the fuses, switch off the device and disconnect the power cord. CAUTION Risk 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 Disposal Action To unlock the fuse holder, push the latches on the right and left inwards together. Pull the fuse holder out. Replace the old fuses with new ones of the same type (see Power cord port, p. 46). Re-insert the fuse holder and ensure that it locks securely in place. • 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 indicates 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 cables Note: Cables to be disposed of due to contact with blood must be disposed of as medical waste, in accordance with environmental regulations. Non-contaminated cables must be disposed of in accordance with the European Directive 2002/96/EC regarding waste electrical and electronic equipment (WEEE). 17 Startup Startup3xxxxxx--XDoc-classRenamic Device Overview Device in operating position 13 12 11 10 Bild 1: Explanation of items Device operating element in working position, viewed from the front right Explanation of the individual items: Item Designation / description Screen (touchscreen) Device body USB ports ECG port Slot for expansion module Screen release button (right) Fixation for carrying strap (right) Pen holder 18 Startup Item Designation / description PGH compartment lid release button 10 Printer buttons 11 Stylus in pen holder 12 Safe program button 13 Emergency shock button Device in transport position 20 19 18 16 15 14 Bild 2: Explanation of items Device operating element in transport position, viewed from the front left Explanation of the individual items: Item Designation / description 14 Carrying handle 15 Fixation for carrying strap (left) 16 Screen release button (left) 18 Paper tray for internal printer 19 On/off button 20 Power cord port and device fuse 19 Startup PGH compartment 27 21 26 22 23 25 24 Bild 3: Explanation of items Device operating elements, PGH compartment with lid open, viewed from above/in front Explanation of the individual items: Item Designation / description 21 PGH port 22 USB slot for Bluetooth USB adapter 23 PGH cable and ECG cable 24 Cable feedthrough for PGH cable 25 On/off LED 26 Programming head (PGH) 27 PGH compartment lid 20 Startup Power cord storage compartment 31 30 29 28 Bild 4: Explanation of items Device operating elements, power cord storage compartment with lid open, viewed from above/behind Explanation of the individual items: Item Designation / description 28 Anti-slip stand 29 Gripping tab 30 Power cord in power cord storage compartment 31 Power cord compartment lid 21 Startup Transportation and Setup Transporting 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. WARNING Danger 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. Setting up the device WARNING Danger to the patient The 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. Tilting the screen up • 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. • 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. 22 Startup The two hinges of the screen arm allow for a wide range of working positions. 2. 1. Bild 5: Tilt radius of the screen and screen arm 23 Startup Connections and Cables Basic notes for cables and connections Note: 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. CAUTION Allergic reactions and inflammations Prevent the cable and programming head from coming into contact with the patient's wounds or skin. Connect 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. 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. Connect ECG cable WARNING Danger to patient by damaged cables Damaged cables are limited in functionality and pose a danger to patients. • Do not use damaged cables. WARNING Danger to the patient Electrostatic 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 Startup WARNING Danger to the patient or user from electrical currents in surface ECG leads Electrical 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. WARNING Danger to patient from allergic reactions If the cable comes into contact with open wounds, it can cause allergic reactions. • Prevent the cable from coming into contact with open wounds. WARNING Danger from loss of function Damp cables have limited functionality and pose a danger to patients. • Do not use damp cables. WARNING Danger from electrical currents Unused 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. Renamic 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 plugs 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 Startup The 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. 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. 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: The USB flash drive used for data transfers must meet the Microsoft Bluetooth Stack standard. Note: The USB port can be disconnected and reconnected while the device is still active. WARNING Danger 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 Startup CAUTION Risk 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 electrically 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 requirements. • Ensure that the leakage currents do not exceed the following maximum values when operating the device within the patient environment: • Housing leakage current Normal condition: 0.1 mA Single fault condition: 1.5 mA • Ground leakage current Normal condition: 0.5 mA Single fault condition: 1.0 mA • Patient leakage current Normal condition: 0.01 mA= / 0.1 mA ˜ Single fault condition: 0.05 mA= / 0.5 mA ˜ • Patient auxiliary current Normal condition: 0.01 mA= / 0.1 mA ˜ Single fault condition: 0.05 mA= / 0.5 mA ˜ There 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. 27 Equipping the device with a Bluetooth adapter Startup If 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 compartment 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 Startup Power Supply Power supply Connecting the power cord to the device 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 / AC The 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 Startup Switching On and Off Switching 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. 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. Startup of the operating system After 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 screen After 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. 30 Switching the device off Startup • 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. CAUTION Danger to data integrity Sudden 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. 31 Using Renamic Using Renamic4xxxxxx--XDoc-classRenamic Keys, Displays and Signals Keys on the device The device has several keys to which fixed functions are assigned. Overview of the device keys: Description Emergency keys • Safe program key to switch on the safe program of the implanted device (emergency pacing). The safe program comes into effect immediately (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) Printer keys Keys for controlling the internal printer (see: Using the Internal Printer, p. 39) On/off key Key for switching the device on and off (see: Switching On and Off, p. 29) • Position of the keys Designation 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. The emergency keys are located on the front of the screen on the lower left. Bild 1: Location of the emergency keys 32 Using Renamic The printer keys are located on the left side of the PGH compartment lid. Bild 2: On/off light indicator Location of the printer keys 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: Buttons on the screen Signal beep • Parameters and measured values • ECG, IEGM and marker channel • Buttons 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. 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 Renamic Emergency Programs QUICK REFERENCE GUIDE FOR EMERGENCIES SAFE PROGRAM (EMERGENCY PACING): Step Action Position the PGH above the implanted device so that telemetry contact is created. Press the safe program button: DELIVER EMERGENCY SHOCK: Step Purpose of the emergency buttons Action Position the PGH above the ICD so that telemetry contact is created. Press the emergency shock button: In the dialog window, select [EMERGENCY SHOCK]. The 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. WARNING Danger to the patient from high electrical energies High levels of electrical energy are conducted to the patient through the emergency programs. • Only activate the safe program or emergency shock under the supervision of a physician. 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. 34 Using Renamic Location of the emergency buttons Bild 3: Start emergency pacing Proceed as follows: Step Stop emergency pacing Action Position the PGH above the implanted device so that telemetry contact is created. Press the safe program button: Proceed as follows: Step Trigger emergency shock Location of the emergency buttons on the device Action Activate the desired permanent parameters in the program of the implanted device and transfer them to the implanted device. Proceed as follows: Step Action Result Position the PGH above the ICD so that telemetry contact is created. Telemetry contact is created between the ICD and the Renamic programmer. 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. • The ICD shock capacitors are charged. • Renamic triggers a 30 or 36 J emergency shock via the ICD. In the dialog window, select [EMERGENCY SHOCK]. 35 Parameter values Using Renamic Tabelle 1: Safe program default parameter values Parameter Value Mode VVI Basic rate 70 ppm Pulse amplitude 7.5 V Pulse width 1.5 ms Tabelle 2: Emergency shock default parameter values Parameter Value Shock waveform Biphasic Type DF (defibrillation shock) Energy • 30 J • Implanted device with high engergy: 36 36 Using Renamic Programming Head Bild 4: Prerequisites Programming head (PGH) with connection cable • 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). CAUTION Risk to magnetically sensitive objects The programming head contains a strong magnet. • Telemetry: Principle Do not place the programming head close to magnetically sensitive objects such as magnetic data media, credit cards or wristwatches. 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). 37 Establishing telemetry Using Renamic 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 contact The LED at the front of the programming head indicates the telemetry contact to the implanted device: Using the safe program LED status (flashing) Telemetry status Green Telemetry contact optimal Orange Telemetry contact in limit range Red Telemetry contact disturbed Off No telemetry contact The programming head is equipped with its own safe program button. Bild 6: Key for the safe program on the programming head This function can be started immediately from any application if the programming head is positioned above the implanted device. WARNING Danger to the patient from high electrical energies High 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 Renamic Communication with Active Implanted Devices Software Interrogating and programming the implanted device 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. BIOTRONIK implanted devices can communicate with Renamic in both directions via the programming head. As soon as the programming head is correctly positioned 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 transferred to the implanted device. The following programs can be transmitted: • Permanent program • Temporary program • Safe program A 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. Note: 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 head Or: • Data transfer Reports Switching off the programmer. 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 realtime ECGs • Connect a USB flash drive 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 markers 39 Using Renamic Using the Internal Printer The 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 device Note: The thermal paper printouts are moisture-sensitive and fade when exposed to strong sunlight. Make copies for permanent documentation. Inserting paper Proceed as follows: CAUTION Printouts that cannot be used or cause damage to the printer The 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 Action 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 Renamic Step Action 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. 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. 41 Print Using Renamic The printer buttons are located on the left front side. Bild 8: Printer buttons Key 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 Renamic Using an External Printer Prerequisites Configurations 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. 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 Bluetooth 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 dielectric 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 Renamic ECG and IEGM Functions Connecting the ECG cable ECG recorder and ECG monitor ECG leads See section: Connect ECG cable, p. 23 All ECGs can be displayed in real time in the recorder or trigger mode and printed on the internal printer. Tabelle 4: Accessories for ECG leads See also: Accessories, p. 49 Lead Patient Device Up to 3 leads (Einthoven) Permitted adhesive and clamp leads PK-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 606012-25). 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: Step Description Test the lead contacts. Remove other devices from the patient. Turn off the sources of interference. 44 Using Renamic 45 Appendix Appendix5xxxxxx--XDoc-classRenamic Technical Data Physical characteristics Category Design Dimensions (W x D x H) 345 x 476 x 125 mm Weight with cables and programming head 10,5 kg 10% Housing material PC/ABS Category Design Classification AIMD according to directive 90/385/ EEC Safety class Protection rating IP 30 Operating mode Continuous operation Category Design Longevity 6 years Category Design Temperature range for operation +10°C ... +40°C Temperature range for storage 0°C ... +50°C Relative humidity 30% ... 75%, no condensation Atmospheric pressure 700 ... 1060 hPa Operation at altitudes Up to 3000 m Category Design Size 12.1' Tilt 35 – 80 ° Resolution 800 x 600 SVGA Contrast Ratio (CR) 200:1 Brightness At least 150 cd/m General classification Longevity Ambient conditions Touch screen 46 Appendix ECG module Category Design Applied part classification BF, defribrillation-proof with PK-222 Leads 3 (Einthoven) A/D converter 12 bits Scan rate 500 ... 1000 Hz Interface Redel plug, 14-pole Category Design Applied part classification BF Dimensions (W x D x H) 145 x 42 x 97 mm Weight 0.3 kg PGH cable 2.9 m Protection rating IP 30 Magnetic flux density Max. 3 mT Interface Redel plug, 14-pole Programming head Power cord port Category Design Supply voltage 100 – 115 V, 10% / 60 Hz / 1.2 A / AC 220 – 230 V, 10% / 50 Hz / 0.6 A / AC Safety class Fuse type 3.15 A; T; 250 V (G fuse IEC 60127 5 x 20 mm) Max. power input Duration 100 W Peak 150 W Efficiency 75% (at 230 V/50 Hz) On/off LED Green LED, lit continuously Mass storage Category Design Type Hard disk Shock resistance Min. 175 G (operating) Min. 700 G (non-operating) Storage capacity Min. 40 GB Magnetic field resistance 50 mT 47 Appendix Internal printer Category Design Type Thermal printer Printing width 4' Resolution 8 Dots/mm Paper Z-fold Paper format (B x L) 112 x 125 mm Paper supply 200 + 10 sheets Category Design Rate band 9 channels 402 – 405 Mhz Range 300 kHz Standard channel 403.65 MHz Modulation FSK Encoding Manchester Data rate 32768, 16384, 8192, 4096, 2048 bit/s (unencoded) Category Design Model GSM/GPRS quadband Motorola Type G24L bzw. G24 GSM rate 850 MHz, 900 MHz, 1800 MHz, 1900 MHz Transmission power 2 W: 850/900 MHz 1 W: 1800/1900 MHz GPRS Multislot class 10 (4 Down, 2 Up) Category Design Model Motorola, 4 band GSM + 3 band UMTS Type H24 UMTS rate 850 MHz, 1900 MHz, 2100 MHz GSM rate 850 MHz, 900 MHz, 1800 MHz, 1900 MHz UMTS transmission power 0,25 W GSM transmission power 2 W: 850/900 MHz 1 W: 1800/1900 MHz UMTS Max. Range: Uplink: 5.76 Mbps Downlink: 7.2 Mbps MICS GSM module UMTS module UE CAT [1-8], 11, 12 supported Compressed mode (3GPP TS25.212) GSM Multi-slot class 12 (4 down, 4 up, 4 total) Coding scheme: CS1–CS4 48 Appendix WLAN module Category Design Transmitter rate Europe: 2,412 GHz bis 2,472 GHz USA: 2,412 GHz bis 2,462 GHz Max. transmission power 100 mW Protocols WEP, WPA, WPA2, HTTPS Standards IEEE 802.11b IEEE 802.11g Channels Europe: 13 channels USA: 11 channels 49 Appendix Scope of Delivery and Accessories Scope of Delivery Renamic (Order no.: 371960) Item designation Amount Order no. WLAN module* Customer-specific 379173 GSM module* Customer-specific 379174 UMTS module* Customer-specific 379366 Without module Customer-specific 365533 Programming head 371588 Power cord Country-specific PK-222-EU / 2.8 m or PK-222-US / 2.8 m Country-specific Bluetooth USB adapter 367929 Stylus 371586 Thermal printer paper 348728 PK Electrode Clip 340293 Multilingual technical manual (de, en, es, fr, it) 377213 Technical manual ZH (printed) Country-specific 370975 Quick reference guide DE (printed) Country-specific 370976 Renamic (single device) Quick reference guide EN (printed) Country-specific 370977 Quick reference guide ES (printed) Country-specific 370978 Quick reference guide FR (printed) Country-specific 370979 Quick reference guide IT (printed) Country-specific 370980 Quick reference guide ZH (printed) Country-specific 370981 *Not available in all countries Accessories Item designation Description Order no. PK-222-EU / 2.8 m ECG cable with banana plug for extremity leads according to Einthoven 335284 PK-222-US / 2.8 m Same as the PK-222-EU with country-specific color coding of the banana plugs 335281 PGH ICD Programming head without magnet with straight cable (2.9 m) 371589 NK-3 Power cord EU 107526 NK-11 (3 m) Power cord US 128865 NK-16-GB (2 m) Power cord for the United Kingdom 330705 NK-19-CN (2.5 m) Power cord for Canada 339034 NK-21-AU,UY (2.5 m) Power cord for Australia and Uruguay 339035 NK-22-AR (2.5 m) Power cord for Argentina 339039 NK-26-CL, IT (2.5 m) Power cord for Chile and Italy 339043 NK-28-DK (2.5 m) Power cord for Denmark 339059 NK-25-CH (2.5 m) Power cord for Switzerland 339042 50 Appendix Item designation Description Order no. NK-27-IL (2.5 m) Power cord for Israel 339044 NK-33-BR (2.5 m) Power cord for Brazil 378933 Memory stick (compatible with Renamic) USB flash memory stick for connection to the USB interface of the programmer; e.g. for data export 350017 USB adapter for serial interface Virtual serial interface via USB 376437 USB adapter for VGA port Virtual VGA interface via USB 377292 Sterile cover 1 Sterile cover for single use on programming head (cannot be re-sterilized) 118022 M 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) 112149 Shoulder strap Carrying strap that can be fixed to the Renamic hangers. 371962 Protective cover Protective cover for Renamic 376999 Optional accessories (compatibility with third party suppliers) Item designation Manufacturer Description H34 SG Kendall ARBO Adhesive electrodes T 60 SKINTACT Adhesive electrodes Type 454 Dahlhausen Adhesive electrodes Type 460 Dahlhausen Adhesive electrodes G 502 GOLMED Clamp lead Cruzer Micro SanDisk USB flash memory stick USB 2.0 to DVI - VGA - HDMI adapter (61644) DeLOCK Visual VGA interface via USB USB 2.0 to Serial (61425) DeLOCK Virtual serial interface via USB G84-4400LUBDE-0 Cherry Keyboard via USB Mouse Dell Maus via USB Passport II; 2.5'; 5400 RPM, 320 GB (WDXMS3200TE) Western Digital External hard drive via USB 51 Appendix Electromagnetic Compatibility in Compliance with EN 60601-1-2:2007 • As the user, you must ensure that the device is operated in a suitable electromagnetic environment. • The following guidelines may not be applicable in all cases. The propagation of electromagnetic values is, for example, affected by the absorption and reflection of structures, objects and people. This data is for your personal information. Devices with the warning sign “Beware of non-ionizing radiation” must not be operated in the environment of the device due to potential interferences. Electromagnetic Emissions (Table 1) Measuring the emitted interference Compliance Guidelines for the electromagnetic environment RF interference according to CISPR 11 Group 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 equipment. RF interference according to CISPR 11 Class 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- Class A lations according to IEC 610003-2 Emitted interference of voltage fluctuations according to IEC 61000-3-3 Recommended safety distances (Table 6) Complies • 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. Note: 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 GHz Maximum output power of the transmitter [W] Safety distance [m] 0.01 0.12 0.12 0.24 0.1 0.37 0.37 0.74 1.17 1.17 2.34 10 3.70 3.70 7.40 100 11.7 11.7 23.4 • 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 52 Appendix maximum output power of the transmitter in watts [W] according to the specification of the transmitter's manufacturer. Transmission frequency 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz Equation d = 1.17 P d = 1.17 P d = 2.34 P Resistance to electromagnetic 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 determine 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. Note: UT is the mains alternating voltage before applying the test levels. Test of resistance to interference Test level according to IEC 60601-1-2 Compliance Guidelines for the electromagnetic environment Electrostatic discharge (ESD) according to IEC 61000-4-2 6 kV contact discharge 8 kV air discharge Same 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%. Same as test level • Ensure that the power supply quality is that of a typical commercial and/or hospital environment. • Ensure that the power supply quality is that of a typical commercial and/or hospital environment. • If you require continued operation during power supply interruptions, connect the device to an uninterruptible power supply or use a battery for operation. • Ensure that the magnetic field strengths are at levels characteristic of a location in a typical commercial and/or hospital environment. Fast transient electric interfer- 2 kV for power supply ences (bursts) according to lines IEC 61000-4-4 1 kV for input and output lines Surges according to IEC 61000-4-5 1kV push-pull voltage 2 kV for commonmode voltage Voltage drops, brief interruptions and fluctuations in the supply voltage according to IEC 61000-4-1 5% UT for 1/2 cycle 95% drop 40% UT for 5 cycles 60% drop 70% UT for 25 cycles 30% drop 5% UT for 5 s 95% drop Same as test level Magnetic field at the supply frequencies (50/60 Hz) according to IEC 61000-4-8 3 A/m Same as test level Note: At 80 MHz and at 800 MHz, the higher frequency range applies. 53 Appendix Test of resistance to interference Test level according to IEC 60601-1-2 Compliance Guidelines for the electromagnetic environment Conducted RF interferences according to IEC 61000-4-6 3 Veff 3V • Radiated RF interferences according to IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m 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. 54 Appendix Country-Related Information UL 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 and Canada Identifications In 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. Industry Canada: • • Renamic: 4708A-RENAMIC Programming head: 4708A-ICSPGH The code IC in front of the approval/registration number indicates that the technical requirements for Industry Canada are met. Federal Communication Commission of the USA: • Renamic: QRIRENAMIC • Programming head: QRIICSPGH Modifications which are not expressly approved by this company may void the rights to operate the devices. FCC RF exposure requirements Your 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 Communications 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 interference 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 Appendix Symbols on the Components Symbols on the right side of the device The symbols mean the following: ECG port with applied part classification BF, defibrillation-proof USB ports Binary interface (slot for expansion module) Follow the instructions in the technical manual! Symbols on the left side of the device The symbols mean the following: On/off button Fuse Follow the instructions in the technical manual! Symbols on the monitor The symbols mean the following: Caution! Emergency shock button Safe program button Symbols on the PGH compartment The symbols mean the following: 10 Key for setting printer speed to 10 mm/s 56 Appendix 25 50 Key for setting printer speed to 25 mm/s Key for setting printer speed to 50 mm/s Key used to stop printing Feed button to feed the paper to the beginning of the next page Symbols in the PGH compartment The symbols mean the following: Programming head connection with applied part classification BF USB port Position and connection of the programming head and position of the ECG cable Follow the instructions in the technical manual! Symbols on the programming head The symbols mean the following: Symbol for the safe program key Position indicator for the programming head 57 Appendix Legend for the Label The label icons symbolize the following: Manufacturing date BIOTRONIK order number Serial number Acceptable temperature ranges for storage Acceptable atmospheric pressure range for storage Acceptable relative humidity range for storage Non-sterile NON STERILE Follow the instructions in the technical manual! Contents Do not use if package is damaged! European approval mark Country-specific restrictions concerning the circulation and implementation of the device Caution: Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician 58 Appendix Device 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 devices Cable and adapter Programming head Warning: Magnetic field 59 Directories Directories6xxxxxx--XDoc-classRenamic List of Keywords Characteristics, 45 Cleaning, 15 Connect external devices ECG cable, 23 Programming head, 23 Connection of external devices Bluetooth adapter, 26 USB devices, 25 Connection of external devices, external printer, 42 Damage, 12 Defibrillation, 11 Device button Emergency pacing, 33 Emergency shock, 33 Disinfecting, 15 Disposal, 16 Disposal of cables, 16 ECG, 43 Electromagnetic compatibility, 51 Electromagnetic emissions, 51 Electromagnetic interference, 14 Test, 14 Electrostatic potentials, 10 Emergency Equipment, 10 Emergency pacing, 33 Emergency shock, 33 Parameter values, 35 Expertise, required, 8 IEGM, 43 Installation site, 12 Intended use, medical, 7 Maintenance, 15 Maintenance, inspection, 15 Maintenance, test before each use, 15 60 Directories Patient environment, 12 Power Supply, 28 Printer external, 42 internal, 39 Programming head, 36 Recommended safety distances, 51 Resistance to electromagnetic interference, 52 Risks, 9 Safe program Key on the programming head, 37 Parameter values, 35 Safety instructions, summary, 10 Scope of delivery and accessories, 49 Software, 38 Sterilization, 15 Technical data, 45 Ambient conditions, 45 ECG module, 46 General classification, 45, 47, 48 Internal printer, 47 Longevity, 45 Mass storage, 46 Physical characteristics, 45 Power cord port, 46 Programming head, 46 Touch screen, 45 Technical manual, 6 Telemetry Principle, 36 Status display for contact, 37 Transport damages, 12 Use with other devices, 13
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