BIOTRONIK ICS 3000 Technical 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 abovementioned directives.
BIOTRONIK GmbH & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel +49 (0) 30 68905-0
Fax +49 (0) 30 6852804
sales@biotronik.com
www.biotronik.com
sbiotronik
1 Contents
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
2 Contents
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
3 Introduction
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.
4 Safe 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.
5 Safety 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 ~
6 Safety 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: l 10%; based
on defibrillation energy
—Contact resistance: 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
7 Safety 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.
8 Safety Instructions
Electromagnetic Compatibility
Note: The ICS 3000 is protected against interference due to
electromagnetic radiation, electrostatic discharge,
and other disturbances, including those associated
with electric power lines. Interference from the
ICS 3000 has also been minimized. Thus, the ICS 3000
meets the requirements of EN 60601-1-2 in every
respect.
Note: The electromagnetic compatibility of the device meets
the requirements specified in the standards. Avoid
strong electrical, magnetic, or electromagnetic fields.
However, strong electromagnetic fields can be
generated by electrical devices and lines (e.g. power
lines, electric motors, PCs, monitors, etc.) in the
immediate vicinity of ICS 3000, which impair the
functioning of ICS 3000. This could lead to an
interruption in the telemetric connection to the
implant, to an erroneous display of the ECG or IEGM,
to malfunctions in operating procedures or similar
problems. If it is not possible to switch off the
interfering device, maintain a minimum distance to
the electromagnetic environment as specified in the
appendix of this manual (see page 42).
Caution! Pay attention to the following device disturbances:
— An unexpected power-down of the device;
— Detection of spontaneous cardiac events not
displayed on the ECG/IEGM screen;
— Interference from an indeterminate source.
Action to take — Turn off the electrical device causing the
interference.
— Remove the source of the interference from the
vicinity of the ICS 3000.
— Move the ICS 3000 away from the vicinity of the
source of interference.
— Switch the ICS 3000 off and then on again.
— If the interference persists, contact BIOTRONIK or
an authorized representative.
9 Instructions for use
Instructions for use
Caution! The ICS 3000 programming and monitoring system is
a sophisticated precision instrument and must
therefore be handled with care. The ICS 3000 can be
damaged by improper handling. Transport it carefully.
Mechanical impact (if, for example, the ICS 3000 or
the programming head is put down hard or dropped)
can impair functioning. In this case, have the device
checked by BIOTRONIK or an authorized
representative.
Note: The ICS 3000 with its OM, DS, and PGH components
may be operated in the vicinity of the patient.
Note: System error messages are generated optically and/
or acoustically.
Note: The ICS 3000 may NOT be used as a life support
system.
Note: The ICS 3000 is portable. The Docking Station and
Operation Module can be used while plugged into the
power supply. The Operation Module can also be used
in wireless mode (with its rechargeable battery pack).
Caution! Detach the Operation Module only by using the release
button on the back of the Operation Module; otherwise
the locking mechanism will be damaged. Follow the
instructions in the software user manual.
Note: The device contains measurement functions that
indirectly serve specific diagnostic purposes.
Caution! Do not operate or store the ICS 3000 in direct sunlight
or under similar heat sources (e.g., halogen lighting).
Also, do not operate it near heaters or other sources
of heat. Exposure to high heat can cause damage.
Caution! Never close or block the ventilation slots on the back
of the device.
Caution! Never remove the label from the housing of the
ICS 3000.
10 Instructions for use
Caution! Never use organic solvents such as ether or acetone
to clean the device. Always ensure that no liquids can
penetrate the device.
Caution! Never sterilize the ICS 3000.
Caution! Do not operate the ICS 3000 near flammable or
explosive materials.
Caution! The ICS 3000 may be used only in spaces suited for
medical purposes and equipped with grounded
alternating current.
Connecting the programmer to the patient
• When used in the operating room, cover the
programming head and the cable connecting it to the
ICS 3000 with a sterile cover.
Caution! Use the safe program function only under the direct
supervision of a physician.
Caution! The ICS 3000 stores programming and diagnostic data
in its memory. In the event of a loss of power or
power-down during operation, all data in the memory
could be lost.
External Defibrillation
Caution! During defibrillation, do not touch the programmer
and its accessories that are attached to the patient.
Caution! The ICS 3000 is protected against defibrillation
current. However, damage to devices connected to
intracardiac leads cannot be ruled out.
• Place the electrodes of an external defibrillator at
least 10 cm away from the implanted electrodes.
• Set the energy level no higher than that required to
achieve defibrillation.
• After external defibrillation, check all the functions of
the ICS 3000; see Inspection B.
11 Instructions for use
Storage and shipping
• Use the provided packaging when returning devices to
the manufacturer. The same environmental conditions
apply to both storage and shipping (see „Technical
Data“ on page 35).
• The thermal paper printouts are moisture-sensitive
and fade when exposed to strong sunlight. Make
copies for permanent documentation.
Self-test
After it has been turned on, the device carries out selftests for approximately 1 minute.
WARNING! The ICS 3000 cannot be used during the self-test. To
ensure the device is always ready for operation, do not
switch it off during an examination.
12 Power Supply
Power Supply
The ICS 3000 has an internal 9.6 V NiMH rechargeable
battery. Nickel metal hydride rechargeable batteries
have a service life of 500 to 700 charging cycles.
Under optimal conditions, the capacity of 3800 mAh
suffices for an uninterrupted system operating time in
modular mode of approximately 1.5 hours.
The power unit supplies all components and
additional modules with electricity. Automatic power
monitoring protects the device from electrical
overload.
Switching On the System
Battery level
indicator
Before switching on the system, you can check the
current battery level with the detached and powereddown Operation Module.
With more than 130 mA battery power, the LEDs light
up independently.
• If the LEDs do not light up, press the battery level
indicator button: The LEDs that indicate the respective
battery level will light up for 4 seconds.
2 yellow, 2 green Battery level 75% – 100%
2 yellow, 1 green Battery level 50% – 75%
2 yellow Battery level 25% – 50%
1 yellow, flashing Battery level < 25%
Note: The Operation Module sends a report when the battery
level is low (see technical manual for the software).
Save all data and connect the Operation Module to the
Docking Station to recharge the battery pack. If you
fail to connect the Operation Module to the Docking
Station before the battery is completely discharged,
the Operation Module automatically saves the current
data and powers down.
13 Switching On the System
On/Off button Use the On/Off button on the Operation Module to
switch on both components if they are connected to
each other for stationary operation and connected to
the power supply.
When the Docking Station is switched on, the green
LED on the right side of the housing will be
illuminated.
System does not
switch on
If the Operation Module cannot be turned on with its
On/Off button, its battery is completely depleted. In
this case, the Operation Module must be operated on
the Docking Station and must be turned on with the
Docking Station’s On/Off button.
• In emergencies, switch on the docking station as well
as the complete system using the ON switch next to
the power connection socket.
Modular operation If you remove the Operation Module from the Docking
Station, the battery pack will provide power for the
continued uninterrupted operation of the Operation
Module.
The green LED on the Docking Station goes out.
On the Operation Module, an illuminated green LED
and the display illumination indicates readiness for
operation.
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