BIOTRONIK Renamic H24 User manual

Renamc
CRM // External Devices // Technical Manual
Medical programmer and monitoring device
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1Table of Contents
Table of Contents
Table of Contents
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
About the Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
About this Technical Manual . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Safety during Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Required Expertise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Residual Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Safety Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . 8
Maintenance, Care and Disposal . . . . . . . . . . . . . . . . . . . . . . 9
Startup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Device Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Transportation and Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Connections and Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Switching On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Using Renamic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Keys, Displays and Signals . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Emergency Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Programming Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Communication with Active Implanted Devices. . . . . . . . . . 30
Using the Internal Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Using an External Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
ECG and IEGM Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Package Contents and Accessories . . . . . . . . . . . . . . . . . . . 37
Electromagnetic Compatibility in Compliance with
EN 60601-1-2:2007. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Country-Related Information . . . . . . . . . . . . . . . . . . . . . . . . 41
Symbols on the Components. . . . . . . . . . . . . . . . . . . . . . . . . 42
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Directories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
List of Keywords. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
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2Introduction
1Introduction
Introduction1377213Technical Ma nualRenam ic
About the Device
General description Renamic is a portable programmer and monitoring device that can be custom-
equipped with a UMTS module.
It is used during the implantation procedure and follow-up of BIOTRONIK implant-
able pacemakers, ICDs (implantable cardioverter-defibrillators), or implantable
cardiac monitors.
Primary functions The device has the following primary functions:
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 BIOTRONIK implantable pace-
makers, cardioverter-defibrillators (ICDs), or implantable cardiac monitors
You will find all explanations of the essential features and basic functions of the
programmer's software in a separate technical manual on the programmer or on
the Internet at the following address: manuals.biotronik.com.
Function Purpose
Programming and testing
functions
Program BIOTRONIK pacemakers, ICDs, and
implantable cardiac monitors during the implanta-
tion 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
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3Introduction
Target group This technical manual is intended for physicians and trained medical personnel who
are familiar with the following:
• The use of implantable pacemakers, ICDs, and implantable cardiac monitors
• 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 pacemakers,
ICDs, and implantable cardiac monitors
• Technical knowledge:
— Ability to work with a PC
— Ability to use software-controlled medical devices
Other technical manuals • Technical manual for the basic functions of the programmer's software
• Technical software manual for programming the intended implantable
pacemaker / ICD / implantable cardiac monitor
• Technical manual for the intended implantable pacemaker / ICD / implantable
cardiac monitor
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4Safety during Use
2 Safety during Use
Safety during Use2377213Technical ManualRena mic
Intended Medical Use
Intended medical use The Renamic programmer provides communication with the implantable pace-
maker, ICD, or implantable cardiac monitor 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
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. Functionality of this medical product has been checked at the location where
the device will be used.
• 2. The staff appointed by the user has been trained 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 appli-
cable 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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5Safety 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.
General Safety Warnings
Note: Failure to observe the safety warning voids all damage claims and manu-
facturer liability.
Technical manual Only use the device in accordance with this technical manual.
Risks of improper handling Disregarding the safety warnings can endanger the patient, the staff and the equip-
ment.
The following dangers may arise in the event of improper use:
• Failure of important device functions
• Personal endangerment due to electrical impact
Installing modules Modules for Renamic should be installed exclusively by trained professionals, who
have extensive experience handling medical electrical devices. In addition, the
BIOTRONK directives must be adhered to.
Changes not permitted Only the manufacturer or a party expressly authorized by BIOTRONIK is allowed to
perform corrective maintenance, enhancements or modifications to the device,
except for the enhancement of modules.
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 Do not use defective or damaged devices.
Physician supervision The device should only be used under constant supervision by 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.
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6Safety during Use
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 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.
External ECG device During the implantation procedure, the patient's heart rate should be additionally
monitored using an ECG monitor or ECG recorder.
Defibrillation • The device is defibrillation protected only if connected with the authorized ECG
cable. Check all device functions after a defibrillation.
• During defibrillation, do not touch the patient, the programmer which the
patient is connected to, or the attached accessories. Otherwise, there is a
danger that you may suffer an electrical shock.
Storage of follow-up data Renamic is not designed for long-term archiving of follow-up data. Ensure archival
of the follow-up data in an external management system by, for example, printing
or exporting the data.
Operating Conditions
Transport and storage • 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 device.
Set-up location Only operate the device in rooms that fulfill the following conditions:
• No danger of explosion
• Suitable for medical purposes
• Class I power outlet with protective conductor 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.
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7Safety during Use
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
multiple socket outlets are switched in.
• When used in combination with other devices, no portable multiple socket
outlets should be used.
• Only those power connection cables which are suitable for medical devices may
be used, e.g. BIOTRONIK power cords (see Accessories, p. 37) or power cords of
equal value labeled H05VV 3 x 0.75 mm, H05VV 3 x 1 mm or SJT AWG18.
To disconnect the programmer from the mains supply, pull its power plug.
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.
Note: In addition to BIOTRONIK's default start parameters, the user-defined start
parameters can also be saved and recalled.
Patient environment This device may be used in the patient environment.
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 simultaneously touch the patient and plug connections such
as USB ports or interfaces for modules or the programming head.
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.
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8Safety 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 the revision valid at the time of delivery) .
However, strong electromagnetic interferences that occur in the close vicinity of
electrical motors, power cables, PCs, monitors, or other – possibly defective – elec-
trical devices may compromise the function of the programmer in certain cases.
This kind of device malfunction should be considered if the following is observed:
• The device switches on by itself.
• The device senses false intrinsic events in the ECG, IEGM or marker channel
(artifacts).
• The device displays other inexplicable functions.
Correct operation of the device can be restored with the following:
• Switch off the malfunctioning electronic device.
• Remove the source of interference from the device.
• Switch the programmer on and off or break the electrical connection between
the device and the source of the interference as much as possible without
causing any danger.
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.
If the interference continues, contact BIOTRONIK immediately.
EMI test The telemetry between the programming head and the implanted device can be
impaired by electromagnetic interference (EMI). This can be observed when it
becomes difficult or even impossible to interrogate or program the implanted
device. Using the EMI test (refer to device software help), the source of the electro-
magnetic interference can be located and then turned off.
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9Safety during Use
Maintenance, Care and Disposal
!
!
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.
The following regulations are valid for the device.
Cleaning and disinfecting • Use lint-free, soft cloths.
• Clean the housing with a damp cloth and mild soap solution or 70% 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 connec-
tions and cables are clean and free of any type of dirt.
• To disinfect the patient cable and patient adapter, use a mixture of 70% isopro-
panol and 30% water or 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 test:
— 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.
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