BIOTRONIK ICS 3000 User manual

ICS 3000
Implant Control System 3000
Cardiac Rhythm Management
Technical Manual
sbiotronik

Implant Control System ICS 3000
USB port
Unlocking key
PGH mount
Covered: PGH port Infrared interface Ventilation slots Paper tray
Release key for the handle
Operation Module
Operational display On/Off button ECG port LEDs: battery charge Battery charge button Screen
Emergency shock button
Safe programm button
Central connect or Screen display hinges Base ON switch Power supply Serial port
Docking
Station
Printer keypad CD drive Carrying handle Operational display
Covered: rechargeable battery Optional: bluetooth interface
Ventilation slots
PGH programming head

336 832/F/707
This product conforms with the directives
90/385/EEC relating to active implantable
medical devices and 99/5/EC on radio
equipment and telecommunication terminal
equipment. It was approved by independent
Notified Bodies and is therefore designated
with the CE mark. The product can be used
in all European Union countries as well
as in countries that recognize the above-
mentioned directives.
BIOTRONIK GmbH & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel [phone]
Fax [phone]
[e-mail]
www.biotronik.com
sbiotronik

1Contents
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Safe Handling of the ICS 3000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . 4
Instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . 9
Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Switching On the System . . . . . . . . . . . . . . . . . . . . 12
Switching Off the System . . . . . . . . . . . . . . . . . . . . 14
Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 16
Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Ports on the Docking Station . . . . . . . . . . . . . . . . . 20
Operation Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Ports on the Operation Module . . . . . . . . . . . . . . . 22
PGH Programming Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Using Basic Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
External Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
ICS 3000 Software . . . . . . . . . . . . . . . . . . . . . . . . . . 27
ECG Recorder and ECG Monitor . . . . . . . . . . . . . . 27
Recording ECGs and IEGMs . . . . . . . . . . . . . . . . . . 28
Miniclinic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Data Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Interrogating and Programming the Implant . . . . 29
Emergency Programs . . . . . . . . . . . . . . . . . . . . . . . 29
Non-invasive Programmed Stimulation . . . . . . . . 31
Analog Telemetry . . . . . . . . . . . . . . . . . . . . . . . . . . 31
The EMI Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
336832--F

2Contents
Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . 32
Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Changing a Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Scope of Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . 40
Approved ECG Electrodes . . . . . . . . . . . . . . . . . . . . 40
Country-Related Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Symbol Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

3Introduction
Introduction
The portable Implant Control System ICS 3000 is
intended for use as a programming and monitoring
system in the implantation and follow-up of
electrotherapeutic implants.
It is a compact unit with numerous functions:
Programmer … for clinical follow up of pacemakers, ICD, and CRT
devices manufactured by BIOTRONIK.
Miniclinic … for monitoring the pacing function of pacemakers
made by other manufacturers.
ECG printer and
ECG monitor
… for real-time display and printing out up to 3 ECG
derivations – surface ECG (Einthoven) – esophageal
lead and up to 3 intracardiac leads.
Data transfer … for transferring program data and the contents of
the diagnostic memory for the purposes of
computerized archiving and evaluation with the
CDM 3000 Cardiac Data Manager.
Documentation … for generating follow-up reports using the
integrated system printer and/or an external printer.
The system is modular and can be configured and
expanded as required. The basic configuration
consists of the following modules:
ICS 3000 DS Docking Station
ICS 3000 OM Operation Module
ICS 3000 PGH Programming Head
ICS 3000 SW Software for programmer, implant programs
Note: Please comply with the technical manuals for the
software and the connected devices.
Warranty
Improper use of the equipment will cause the
warranty for the ICS 3000 and accessories to become
invalid.

4Safe Handling of the ICS 3000
Safe Handling of the ICS 3000
Intended Use
The ICS 3000 is intended for use by physicians and
trained medical personnel. To use the system,
individuals must have a fundamental medical
understanding of the respective therapy and detailed
knowledge of how the implant functions and the
conditions for its use. The operator should be present
at all times when the ICS 3000 is in use.
Residual risk No risks are associated with the programming system
if it is used correctly and has been serviced and
inspected according to BIOTRONIK specifications. The
risk evaluation by the Risk Management Team has
determined that the residual risk is as low as
reasonably possible.
Safety Instructions
Note: The ECG connection makes electrical contact with the
patient via the electrodes. It is an applied BF-type part
and is defibrillation-proof when the approved patient
cable is used.
Caution! Never simultaneously touch the patient and connector
components that conduct safety extra-low voltage.
Note: When working with the software, maintain minimum
amplitudes or values of physiologic patient signals. If
these values are not met, inaccurate results may be
produced.
WARNING! Do not use the ICS 3000 on the patient in conjunction
with RF-surgical equipment.
WARNING! During diagnosis, therapy or implantation with the
ICS 3000, keep emergency equipment ready: external
defibrillator and external stimulator, devices for
monitoring cardiac activity.

5Safety Instructions
Device Combinations
Caution! When using devices in combinations, it is absolutely
essential that all the devices are connected to
permanently installed outlets of the same power
supply destined for medical use. Do not use any
outlets that can be moved (such as extension cables,
multiple outlets, etc.).
• Connect only devices of Safety Class I which meet the
standards EN 60950 or IEC 950 and are at least 1.50 m
away from the patient. Before starting the devices,
check the overall leakage currents in accordance with
EN 60601-1-1.
• Ensure that the leakage currents do not exceed the
following maximum values when operating the device
within the patient’s vicinity (* NC Normal Condition /
** SFC Single Fault Condition):
Caution! Connecting additional devices to the ICS (monitor,
CDM 3000, external printer) may cause leakage
current limits to be exceeded. Combine only devices
that comply with the standards EN 60950 or IEC 950
and that are set up outside of the patient environment
at a distance of at least 1.50 meters. For each device
combination, compliance with the overall leakage
currents must be established and documented before
putting it into operation. However, the test must be
repeated in accordance with legal requirements and
at least once a year.
NC*SFC**
Housing leakage current 0.1 mA 0.5 mA
Ground leakage current 0.5 mA 1.0 mA
Patient leakage current 0.01 mA = 0.05 mA =
0.1 mA ~ 0.5 mA ~
Patient auxiliary current 0.01 mA = 0.05 mA =
0.1 mA ~ 0.5 mA ~

6Safety Instructions
Accessories
• Use only accessories that have been approved by
BIOTRONIK. BIOTRONIK-approved device
combinations can be used if the device to be
connected complies with the IEC 601 / EN 60601 / VDE
0750 standards series and this conformity is
substantiated by CE certification conducted by an
independent, Notified Body.
Caution! Using unapproved accessories can impair the
electromagnetic compatibility, cause leakage
currents to exceed permissible levels, reduce the
dielectric strength, and cause functional disturbances
in both the hardware and software.
Cables
Caution! The plugs of the patient cable may not touch any
conductive or grounded components! Secure any
unused patient cable connectors. Never
simultaneously touch the patient and connector
components that conduct safety extra-low voltage.
PK-222 Device: Redel, P series, 14-pin, 40° coded
— Defibrillation protection: 5 kV,
according to EN 60601-2-25 voltage limitation
to nominal 15 V nominal, 100 V maximum
— Maximum energy consumption: l10%; based
on defibrillation energy
—Contactresistance:10kz
— Weight 0.2 kg
Patient: 4 color-coded banana plugs
PK-199 Oesophagus Patient: 4-pin Redel plug for the esophageal lead and
four 4 mm- banana plugs for the surface leads
Device: Redel, P series, 14-pin, 40° coded
NK-3 Device: Right-angle cold device socket
Power supply: Shockproof right-angle plug
422U/311

7Safety Instructions
Operating conditions
Caution! The ICS may be operated only in areas used for
medical purposes (in accordance with DIN VDE
0107:1994). Do NOT operate the ICS 3000 in areas
where there is a risk of explosion.
Note: The ICS 3000 is designed to be operated and stored in
an enclosed area.
• Operate the ICS 3000 and its individual components
only after placing it on a stable, level surface (e.g., a
table).
Caution! Connect only the BIOTRONIK power supply cable to
the power supply; never use any other cables for the
ICS 3000.
WARNING! Never connect the ICS 3000 to the patient at the same
time you are using electrosurgical instruments (such
as an electrocautery). This might harm the patient
and/or cause improper or unpredictable functioning of
the device.
WARNING! Under no circumstances should you attempt to
change settings by selecting the parameter(s) several
times in rapid succession. This could produce
unintended results.
Caution! The ICS 3000 has a touch screen for all input. Exercise
care in configuring the settings, so that you do not
activate an undesired function unintentionally.
WARNING! Use the safe program function only under the direct
supervision of a physician.
WARNING! Keep an external defibrillator available when using
the NIPS function.