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 . . . . . . . . . . . . . . . . . .
4 Table of Contents
5 1 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).
6 Introduction About this Technical Manual Objective This technical manual provides the user with all the safety information required to use the Renamic programmer.
7 2 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.
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.
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.
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.
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.
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.
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).
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.
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.
17 3 Startup Startup3xxxxxx--XDoc-classRenamic Device Overview Device in operating position 13 1 12 2 11 3 10 4 5 9 8 6 7 Bild 1: Explanation of items Device operating element in working position, viewed from the front right Explanation of the individual items: Item Designation / description 1 Screen (touchscreen) 2 Device body 3 USB ports 4 ECG port 5 Slot for expansion module 6 Screen release button (right) 7 Fixation for carrying strap (right) 8 Pen holder
18 Startup Item Designation / description 9 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
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.
22 Startup The two hinges of the screen arm allow for a wide range of working positions. 2. 1.
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.
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.
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.
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.
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.
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.
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.
31 4 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: 1 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.
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.
33 Using Renamic Emergency Programs QUICK REFERENCE GUIDE FOR EMERGENCIES SAFE PROGRAM (EMERGENCY PACING): Step Action 1 Position the PGH above the implanted device so that telemetry contact is created. 2 Press the safe program button: DELIVER EMERGENCY SHOCK: Step Purpose of the emergency buttons Action 1 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].
34 Using Renamic Location of the emergency buttons Bild 3: Start emergency pacing Proceed as follows: Step Stop emergency pacing Action 1 Position the PGH above the implanted device so that telemetry contact is created. 2 Press the safe program button: Proceed as follows: Step 1 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.
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.
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.
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.
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.
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.
40 Using Renamic Step Action 2 3 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.
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).
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.
44 Using Renamic
45 5 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 I Protection rating IP 30 Operating mode Continuous operation Category Design Longevity 6 years Category Design Temperature range for operation +10°C ...
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.
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.
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.
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 1 371588 Power cord 1 Country-specific PK-222-EU / 2.8 m or PK-222-US / 2.
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.
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.
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.
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.
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.
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
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 m
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
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.
59 6 Directories Directories6xxxxxx--XDoc-classRenamic List of Keywords C 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 D Damage, 12 Defibrillation, 11 Device button Emergency pacing, 33 Emergency shock, 33 Disinfecting, 15 Disposal, 16 Disposal of cables, 16 E ECG, 43 Electromagnetic compatibility, 51 Electromagnetic emissions, 51 Ele
60 Directories P Patient environment, 12 Power Supply, 28 Printer external, 42 internal, 39 Programming head, 36 R Recommended safety distances, 51 Resistance to electromagnetic interference, 52 Risks, 9 S 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 T Technical data, 45 Ambient conditions, 45 ECG module, 46 General classification, 45, 47, 48 Internal printer, 47 Longevity, 45 Mass