BIOTRONIK SE and KG RENAMIC User Manual
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
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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).
Primary functions The device has the following primary functions:
Function Purpose
Programming and testing
functions
ECG recorder and ECG
monitor
Data management Store parameter values and ECG/IEGM recordings
Documentation Print out follow-up reports using the internal and/
Program BIOTRONIK pacemakers and ICDs during
the implantation procedure or follow-ups
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
for computer-aided archiving and evaluation
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:
•Device startup
• Interrogation, testing and programming of implantable pulse generators and
cardioverter-defibrillators (ICD)
Target gro up 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
• Technical knowledge:
— Ability to work with a PC
— Ability to use software-controlled medical devices
and ICDs
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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2 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
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.'
Residual Risk
Risk analysis The risk analysis carried out by the manufacturer's Risk Management Team has
9 Safety During Use
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 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
accessories
Defects Do not use defective or damaged devices.
Physician supervision The device should only be used under the constant supervision of a physician.
Patient observation Ensure that patients are individually observed over a suitable period of time in
Emergency equipment Always ensure that in the event of an emergency the following basic equipment is
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.
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.
order to monitor the compatibility and effectiveness of parameter combinations.
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.
11 Safety During Use
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.
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.
• 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 60364-7710:2002 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.
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.
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 The device may not be used on the patient in conjunction with high frequency
surgical equipment.
Start parameters and
default settings
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 Safety During Use
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
1 To unlock the fuse holder, push the latches on the right and left
inwards together.
2 Pull the fuse holder out.
3 Replace the old fuses with new ones of the same type (see Power
cord port, p. 46).
4 Re-insert the fuse holder and ensure that it locks securely in
place.
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).
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3Startup
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Device Overview
Device in operating position
Bild 1: Device operating element in working position, viewed from the front right
Explanation of items Explanation of the individual items:
Item Designation / description
1 Screen (touchscreen)
2 Device body
3USB ports
4ECG port
5 Slot for expansion module
6 Screen release button (right)
7 Fixation for carrying strap (right)
8 Pen holder
18 Startup
14
15
16
18
19
20
Device in transport position
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
Bild 2: Device operating element in transport position, viewed from the front left
Explanation of items 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
21
22
23
24
27
26
25
PGH compartment
Bild 3: Device operating elements, PGH compartment with lid open, viewed from above/in
front
Explanation of items 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
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