ICS 3000 Programmer Technical Manual Rev G Jan 2010

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Implant Control System ICS 3000 Operation Module Operational display On/Off button ECG port

PGH programming head

LEDs: battery charge

PGH mount

Battery charge button

Covered: PGH port Infrared interface

Screen

Optional: bluetooth interface

VGA port USB port Unlocking button Central connector

Emergency shock button

Screen display hinges

Covered: rechargeable battery

Ventilation slots

Base

Safe programm button

Power supply ON switch

Printer keypad

Paper tray

CD drive Carrying handle Release button for the handle

336832--G_GA_ICS3000_U2-Tiel-Inn1-2 1-2

Serial port

Docking Station

Operational display

Ventilation slots

USB port

04.08.2009 11:43:39

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Contents

Contents Introduction... 3 Safe Handling of the ICS 3000... 4 Intended Use... 4 Safety Warnings... 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... 24 Using Basic Functions... 27 External Printer... 27 USB Interfaces... 28 ICS 3000 Software... 29 ECG Recorder and ECG Monitor... 29 Recording ECGs and IEGMs... 30 Miniclinic... 30 Data Transfer... 31 Documentation... 31 Interrogating and Programming the Implant... 31 Emergency Programs... 32 Non-Invasive Programmed Stimulation... 33 Analog Telemetry... 34 EMI Test... 34

336832--G

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Contents

Care and Maintenance... 35 Cleaning and Disinfection... 35 Sterilization... 36 Maintenance... 36 Changing a Fuse... 37 Disposal... 37

Technical Data... 38 Scope of Delivery... 42 Standard... 42 Optional accessories... 42 Approved ECG Leads... 43

Country-Related Information... 44 Electromagnetic Compatibility... 45 Symbol Index... 49 Index... 51

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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 follow-up of pacemakers and ICDs manufactured by BIOTRONIK.

Miniclinic

... for monitoring the pacing function of pacemakers made by other manufacturers.

ECG recorder and ECG monitor

... for real-time display and printing out up to 3 ECGleads – surface ECG (Einthoven) – esophagus 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 and 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.

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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 basic 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 Warnings Note:

The ECG port makes electrical contact with the patient via the leads. 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 port components that conduct safety extra-low voltage.

Note:

When working with the software, maintain minimum amplitudes or values for 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.

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Safe Handling of the ICS 3000

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 mains used for medical purposes. Do not use portable power strips.

Caution!

Connecting external devices such as monitors or printers may cause leakage current limits to be exceeded.

•

Only connect devices which comply with the respective ISO, EN, or IEC standards (such as IEC 60601-1 or IEC 60950).

•

Devices which do not comply with IEC 60601-1 must be set up outside the patient's vicinity (at least 1.5 meters away from the patient).

•

For each device combination, test and document compliance with the overall leakage current limits in accordance with IEC 60601-1-1 before using the combination for the first time. This test must be repeated in accordance with legal requirements and at least once a year.

•

Ensure that the leakage currents do not exceed the following maximum values when operating the device within the patient's vicinity: Housing leakage current

NC*

SFC**

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 ~

* NC Normal Condition ** SFC Single Fault Condition

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Safe Handling of the ICS 3000

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 malfunctions in both the hardware and software. Cables

Caution!

The plugs of the ECG cables must not touch any conductive or grounded components! Secure any unused patient cable connectors. Never simultaneously touch the patient and port 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 15 V nominal, 100 V maximum - Maximum energy consumption: l 10 %; relative to defibrillation energy - Transfer resistance: 10 kz - Weight 0.2 kg Patient: 4 color-coded banana plugs

PK-199 Oesophagus

Device: Redel, P series, 14-pin, 40° coded Patient: Redel, P series, 10-pin, 60° coded; for connecting a catheter Osypka TO slim, 2/5 F

NK-3

Device: Right-angle cold device socket Power supply: Shockproof right-angle plug 422U/311

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Safe Handling of the ICS 3000

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 mains cables from BIOTRONIK 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 device). 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 only under the supervision of a physician.

WARNING!

Keep an external defibrillator available when using the NIPS function.

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Safe Handling of the ICS 3000

Electromagnetic compatibility Note:

The ICS 3000 is protected against interference resulting from electromagnetic radiation, electrostatic discharge and other sources, including interference from cables. Interference emitted from the ICS 3000 has also been minimized. The ICS 3000 thus meets the requirements of IEC 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 which impair the functioning of the ICS 3000 can be generated by electrical devices and lines (e. g. power lines, electric motors, PCs, monitors, etc.) in the immediate vicinity of the 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 device causing interference, maintain a minimum distance to the electromagnetic environment as specified in the appendix of this manual (see page 45).

Caution!

Pay attention to the following device malfunctions: - An unexpected power-down of the device; - Detection of spontaneous cardiac events which are not displayed on the ECG/IEGM screen; - Interference from an indeterminate source.

Action to take

- Turn off the electrical device which is causing the interference. - Remove the source of 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.

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Safe Handling of the ICS 3000

Instructions for Use Caution!

The ICS 3000 is a sophisticated precision instrument and must therefore be handled with care. The ICS 3000 could 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) may impair functioning. In this case, have the device checked by BIOTRONIK or an authorized representative.

Note:

The ICS 3000 with its components OM, DS, and PGH may be operated in the vicinity of the patient.

Note:

System errors are indicated visually 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 mains 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 unlocking button on the back of the Operation Module; otherwise the unlocking mechanism will be damaged. Proceed as described in the technical manual “Handling Basics.”

Note:

The device contains measurement functions that indirectly serve 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 may cause damage.

Caution!

Never close or block the ventilation slots on the back of the device.

Caution!

Never remove the labels from the housing of the ICS 3000.

Caution!

Never use organic solvents such as ether or acetone to clean the device. Always ensure that no liquids can penetrate the device.

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Safe Handling of the ICS 3000

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 areas 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 which is connecting it to the ICS 3000 with a sterile cover.

Caution!

Use the safe program function only under the 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 or its accessories that are attached to the patient.

Caution!

The ICS 3000 is protected against defibrillation energy. However, damage to devices connected to intracardiac leads cannot be ruled out.

•

Place the leads of an external defibrillator at least 10 cm away from the implanted leads.

•

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.

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Safe Handling of the ICS 3000

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 38).

•

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.

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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 supply unit supplies electricity to all components and additional modules. Automatic power monitoring protects the device from electrical overload.

Switching On the System Battery level indicator

To assure yourself of the current battery level, you can check the detached and powered-down Operation Module prior to switching on the system. At more than 130 mA charging current, 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 Note:

Battery level < 25% The Operation Module sends a message when the battery level is low (see the 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.

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Power Supply

ON/OFF button

Use the ON/OFF button on the Operation Module to switch on both components if they are connected to each other and connected to the mains for stationary operation.

When the Docking Station is switched on, the green LED on the right side of the housing illuminates. System does not switch on

If you are unable to switch on the system using the ON/ OFF button on the Operation Module, the battery is depleted. In this case, operate the Operation Module on the Docking Station (which has to be connected to the mains) and turn it on using the Docking Station's ON switch.

•

In emergencies, use the ON switch next to the mains connection to switch on the Docking Station and thus the complete system.

Modular operation

If you remove the Operation Module from the Docking Station, the battery pack will provide power for the continued uninterrupted operation. The green LED on the Docking Station goes out. On the Operation Module, an illuminated green LED and the display illumination indicate ready-for-service status.

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Power Supply

Switching Off the System Normal shut-down

When you press the ON/OFF button on the Operation Module briefly, it switches to standby mode within a few seconds. - The data are saved. - A dialog box opens. - The battery level of the rechargeable battery is checked; if it is fully charged, the Operation Module and Docking Station will switch off automatically after 30 seconds. If the Operation Module is docked, the system is connected to the mains and the battery is no longer fully charged, it will be recharged automatically (see also "Automatic battery recharge" on page 15). - The system shuts down completely only after the battery has been recharged.

Note:

After a normal shut-down, the ICS is quickly ready for operation again: Depending on the preference settings, a restart takes 30 or 60 seconds.

Forced shut-down

You can force the system to shut down if the software does not respond to a brief press on the button for normal shut-down. When you press the ON/OFF button for about 3 seconds, the Operation Module switches off immediately. - Any unsaved data is lost. - The battery is not automatically recharged. - The subsequent restart takes about 60 seconds.

WARNING!

In case of an emergency, switch off the device by pulling its plug. As the shut-down is delayed, the ON/OFF button on the Operation Module is unapt to effectively switch off the device in an emergency. The ON button on the Docking Station is used only to switch the device on.

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Power Supply

Automatic battery recharge Automatic battery recharging begins after a normal shut-down. The recharging status is plotted on the Operation Module display as a percentage. The LEDs light up in reverse sequence; see "Battery level indicator" on page 12. Note:

If the LED indicator for battery level does not match the display on the Operation Module, a complete maintenance cycle must be performed (see "Manual battery maintenance" on page 16). Depending on the battery level, recharging may take up to 4 hours. When recharging is completed, the LEDs will turn off.

Battery is not recharged

- The Operation Module and Docking Station are not connected to each other. - The battery is of poor quality; for example, it is too old or has been poorly maintained. - The ICS underwent a forced shut-down (ON/OFF button was pressed longer than 3 seconds). - The internal operating temperature is too high after switching on or during operation. - No mains connection.

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Power Supply

Battery Maintenance The battery in the Operation Module must be maintained in order to extend its total service life. The battery can be subjected to a maintenance cycle automatically on a regular basis, as well as manually on special occasions. Automatic battery maintenance Automatic maintenance is performed on the battery once a month after normal shut-down if the ICS is configured to do so (see the technical manual for the software). The maintenance cycle lasts approximately 14 hours and includes battery charging, complete discharge, and recharge. Charging status

The charging status – either charge or discharge – is plotted on the display.

Note:

To ensure a complete charge or discharge cycle of the battery, do not switch off the system during battery maintenance. If necessary, operate the system in stationary mode.

Turn off automatic battery maintenance

In the program, set: "More" > "Preferences" > "System" "Auto battery maintenance" > "OFF" Manual battery maintenance

1

In the program, set: >"More " >"Preferences" >"System" > "Auto battery maintenance"

2

The maintenance cycle is usually completed within 14 hours. Both charging phases take 3 hours; the discharge phase takes about 8 hours. After a complete maintenance cycle, the LEDs no longer illuminate.

3

Check the battery level using the battery level indicator button. If the battery is full, all 4 LEDs will briefly flash.

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Docking Station

Docking Station The Docking Station is the mains-operated base unit of the system and is used only in conjunction with the Operation Module. Additional modules can be docked in expanded versions. Ventilation slots

• Carrying handle

Caution!

A temperature-controlled fan ensures optimal cooling.

The ventilation slits must remain clear. When you press the handle release button, the handle is immediately fully extended.

To lift the ICS 3000 by its handle, fold the Operation Module down completely; otherwise, the programming head could fall out of its mount.

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Docking Station

Docking and disconnecting the Operation Module A central connector connects the Docking Station to the Operation Module.

•

Detach the Operation Module only by using the unlocking button on the back of the Operation Module; otherwise, the unlocking mechanism can be damaged (see also the technical manual for the software). CD drive The CD drive is used for updating ICS software, installing the CD supplied by BIOTRONIK with technical manuals, and for data back-up (provided a CD burner is available).

•

The CD holder extends when you press the black button on the drive itself.