BIOTRONIK ICS 3000 Manual de usuario

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 +49 (0) 30 68905-0

Fax +49 (0) 30 6852804

sales@biotronik.com

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.

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