3Table 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
4Table of Contents
5
1 |
Introduction |
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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:
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Purpose |
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Programming and testing |
Program BIOTRONIK pacemakers and ICDs during |
functions |
the implantation procedure or follow-ups |
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ECG recorder and ECG |
Display and printout of up to three leads of surface |
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ECGs, as well as up to three intracardiac deriva- |
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tions (IEGMs) and the corresponding event |
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markers, in real-time |
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Data management |
Store parameter values and ECG/IEGM recordings |
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for computer-aided archiving and evaluation |
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Documentation |
Print out follow-up reports using the internal and/ |
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or external printer |
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6Introduction
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:
•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 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
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Safety During Use |
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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
8Safety 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 This ordinance only applies in the Federal Republic of Germany. However, we ordinance 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.'
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Residual Risk
Safety During Use
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.
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Safety During Use |
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General Safety Instructions
Technical 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.
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 To ensure safety compliance, use only original replacement parts and accessories 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 drugs
For 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.
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Safety During Use |
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External 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.
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Safety During Use |
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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.
•Do not use the device if it shows visible damage.
•Contact BIOTRONIK for testing and, if necessary, repair of the equipment.
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 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 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.
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Safety During Use |
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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 The device may not be used on the patient in conjunction with high frequency surgical equipment.
Start parameters and Once switched on, the device functions according to BIOTRONIK's default settings 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 |
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Electromagnetic Interference
Possible electromagnetic The programmer is protected from disturbances resulting from electromagnetic interference 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.
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Safety During Use |
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Maintenance, Care and Disposal
The following regulations are valid for the device.
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WARNING |
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Exposure to fluids may result in fatal injury |
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Before cleaning and disinfecting device surfaces: Pull the power plug! |
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CAUTION |
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Danger of explosion if exposed to cleaning and disinfecting agents |
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Let cleaning and disinfection agents evaporate before operating the device. |
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CAUTION |
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May be damaged by cleaning agents |
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Strong and abrasive cleaning agents and other organic solvents, such as ether or |
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benzine, corrode the surface of the device and must not be used. |
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Cleaning and disinfecting |
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• Use lint-free, soft cloths. |
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• Clean the housing with a damp cloth and mild soap solution or 70% isopro- |
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panol. |
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Disinfect with alcohol or aldehyde-based agents such as Aerodesin 2000, |
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Fugaten spray, Lysoformin 2000 or Aldasan 2000. |
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• Vacuum the ventilation slots regularly. |
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• Visually inspect the connections: make sure that the contacts for all connec- |
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tions and cables are clean and free of any type of dirt. |
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• To disinfect the patient cable and patient adapter, use a mixture of 70% isopro- |
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panol and 30% water oder Lysoformin 3000: Allow it to take effect for 15 |
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minutes at 2% concentration. |
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Sterilization |
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• The device cannot be sterilized. |
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Test before each use |
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• A short test of the device and the approved accessories should be performed |
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prior to each use. This test consists of the following visual inspections and a |
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simple functional tests: |
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— Inspect the housing for mechanical damage, dents, loose parts, cracks, etc. |
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— Inspect cables and connection areas to ensure proper insulation, no breaks, |
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etc. |
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— Inspect that the stylus is in place |
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— Inspect the labeling for legibility |
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— Inspect the displays (e.g. time and date) |
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— Simple electrical function test: switch the device on; an internal function |
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test will be conducted automatically |
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— If no error message appears, then no errors were found and the device can |
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be used |
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16 |
Safety During Use |
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Inspection 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.
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 |
Action |
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To unlock the fuse holder, push the latches on the right and left |
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inwards together. |
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Pull the fuse holder out. |
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Replace the old fuses with new ones of the same type (see Power |
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cord port, p. 46). |
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Re-insert the fuse holder and ensure that it locks securely in |
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place. |
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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 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
3 |
Startup |
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Device Overview
Device in operating position
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Bild 1: Device operating element in working position, viewed from the front right |
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Explanation of items |
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Explanation of the individual items: |
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Item |
Designation / description |
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Screen (touchscreen) |
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Device body |
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USB ports |
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ECG port |
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Slot for expansion module |
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Screen release button (right) |
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Fixation for carrying strap (right) |
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Pen holder |
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18 Startup
Item |
Designation / description |
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9 |
PGH compartment lid release button |
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Printer buttons |
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Stylus in pen holder |
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Safe program button |
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Emergency shock button |
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Device in transport position
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Bild 2: Device operating element in transport position, viewed from the front left |
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Explanation of items |
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Explanation of the individual items: |
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Designation / description |
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14 |
Carrying handle |
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Fixation for carrying strap (left) |
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Screen release button (left) |
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Paper tray for internal printer |
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On/off button |
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Power cord port and device fuse |
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19 Startup
PGH compartment
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Bild 3: Device operating elements, PGH compartment with lid open, viewed from above/in
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Explanation of items Explanation of the individual items: |
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PGH port |
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USB slot for Bluetooth USB adapter |
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PGH cable and ECG cable |
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Cable feedthrough for PGH cable |
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On/off LED |
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Programming head (PGH) |
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PGH compartment lid |
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