Technical Manual sbiotronik Implant Control System 3000 Cardiac Rhythm Management ICS 3000
Release key for the handle Carrying handle CD drive Printer keypad Safe programm button Emergency shock button Docking Station Operation Module Implant Control System ICS 3000 USB port Operational display Serial port ON switch Power supply Base Screen display hinges Central connect or Screen Battery charge button LEDs: battery charge ECG port On/Off button Operational display Ventilation slots Unlocking key PGH mount PGH programming head Ventilation slots Paper tray Infrared int
36 832/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.
1 Contents Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Safe Handling of the ICS 3000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . 4 Instructions for use . . . . . . . . . . . . . . . . . . . . . . . . . 9 Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 Contents Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . 32 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Changing a Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Technical Data . . . . . . .
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.
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.
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.
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.
7 Safety Instructions Operating conditions Caution! Note: 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. 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).
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.
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.
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.
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.
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.
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.
14 Switching Off the System Switching Off the System Normal shut-down When you press the On/Off button quickly, the Operation Module switches to standby mode within a few seconds. — The data are saved. — The screen goes black. — 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.
15 Switching Off the System Automatic Battery Recharge Automatic battery recharging begins after a normal shut-down. The recharging status is shown graphically on the Operation Module display as a percentage. The LEDs light up in reverse sequence; see „Battery level indicator“ on page 12. Depending on the battery level, recharging may take up to 4 hours. When recharging is completed, the LEDs go out. Battery is not recharged — The Operation Module and Docking Station are not connected to each other.
16 Battery Maintenance Battery Maintenance The rechargeable battery is automatically serviced every 4 weeks after normal shut-down, if the ICS is configured to do this (see technical manual for the software). The maintenance cycle lasts approximately 12 hours, and includes battery charging, complete discharge and recharge. Charging status The charging status – either "Charging" or "Discharging" – is indicated graphically on the display.
17 Docking Station Docking Station The Docking Station is the power-driven base unit of the system, which is used only in conjunction with the Operation Module. Additional modules can be connected to the expanded versions. Ventilation slots • A temperature-controlled fan ensures optimal cooling. The ventilation slits must remain clear. Carrying handle Note: When you press the handle release key, the handle is immediately fully extended.
18 Docking Station Connecting and Disconnecting the Operation Module A central connector connects the Docking Station to the Operation Module. • Use only the unlocking key on the back of the Operation Module to disconnect it; otherwise the release mechanism can be damaged (see also the technical manual for the software). CD Drive The CD drive is used for updating ICS software, the installation of the CD supplied by BIOTRONIK with instructions for use, and – if a CD writer is available – data back-up.
19 Docking Station Internal Printer The ICS 3000 includes a high-resolution, graphicscapable thermal printer. The device prints on ICS 3000 thermal folding paper (see „Scope of Delivery“ on page 39). Note: The thermal paper printouts are moisture-sensitive and fade when exposed to strong sunlight. Make copies for permanent documentation. • To open the paper tray, lift the lever below the recessed handle on the paper tray and pull out the tray.
20 Ports on the Docking Station Ports on the Docking Station Caution! USB Caution! Serial port • Note: Never simultaneously touch the patient and connector components that conduct safety extra-low voltage. Port for USB data stick, mouse or printer – with the Operation Module connected. Connect only devices which do not have their own power supply; with regard to external printers, you must comply with the specifications listed on page 26.
21 Operation Module Operation Module PC based The Operation Module is the central operating, control and data storage unit for the entire system. For information on the power supply, see page 12. See also „Connecting and Disconnecting the Operation Module“ on page 18. — A system clock guarantees precision of ±10 minutes per year. — The system battery lasts for 10 years. — The system is equipped with a sound chip and a loudspeaker for acoustic signals.
22 Ports on the Operation Module Ports on the Operation Module Note: The ECG and PGH ports are mechanically coded; it is not possible to connect the cables incorrectly. ECG port The ECG module is used with extremity leads: 3-channel ECG (Einthoven) and a miniclinic to monitor the functioning of implants.
23 PGH Programming Head PGH Programming Head ICS 3000 PGH (Programming head) Note: Communication between the programmer and the implant takes place by means of telemetry via the ICS 3000 PGH (programming head). The output data from the implant (digital and analog) are converted into digitally coded impulses and transmitted over an inductive coupling between the coils of the programming head and those of the implant. Connect the programming head to the Operation Module before you turn it on.
24 PGH Programming Head Note: Caution! • Each programming head features a diagram of the implant to assist in positioning the head. Silicone nubs on the underside prevent the head from slipping. To program and interrogate the implant, the programming head is brought into physical contact with the patient. The programming head contains a strong magnet. Do not place it close to magnetically sensitive objects such as computer diskettes or wristwatches.
25 PGH Programming Head Conductor to ICS: PGH with straight cable The ICS 3000 is operated with the PGH programming head, which may have a spiral cable or a straight cable as a conductor. If the Operation Module is used in portable fashion, there is a danger of tripping if there is a straight cable hanging down loose. • Note: When transporting the unit, wind a straight PGH cable around the mount on the back of the operation module as shown below.
26 Using Basic Functions Using Basic Functions External Printer You can connect an external printer to the programmer under the following electrical safety conditions: With the exception of the wireless connection, after the system has been installed in the hospital, compliance with the leakage current limit values according to EN 60601-1-1, Paragraph 19 must be demonstrated.
27 ICS 3000 Software ICS 3000 Software Software updates are performed by authorized persons using a CD-ROM. Installing the CD • Languages • Programmer Technical manuals for the implant programs are supplied on an additional CD. The CD contains technical manuals in PDF format for printing and in HTML format for help. Please follow the installation instructions on the CD. Language settings are found under "More" > "Preferences" > "Language".
28 Recording ECGs and IEGMs Recording ECGs and IEGMs The intracardiac electrograms received from the implant as well as the surface ECG and the esophageal lead can be simultaneously displayed and printed. The recording of the surface ECG does not depend on other functions, so that the implant can be interrogated and programmed during the ongoing ECG display. The recorded electrograms can be saved and measured with electronic calipers.
29 Data Transfer Data Transfer The follow-up data can be saved, sorted and exported. — Connection of an external PC system for data processing (e.g., CDM 3000 Cardiac Data Manager) — Connection of an external printer for printing out all the data with the exception of real-time ECGs — Connection of a USB data stick Documentation Internal printer for the complete documentation of: — all follow-up reports (e.g.
30 Emergency Programs Calling up and Triggering the Safe Program 1 Position the programming head over the implant. The safe program switches on the pacemaker, and paces it at 10 V and 70 ppm. 2 Press the safe program button on the Operation Module or the programming head (see page 23). Calling up and Triggering an Emergency Shock In the ICS 3000, the emergency shock command is issued by the hardware button; the emergency shock is always generated by the implant according to the preset implant program.
31 Non-invasive Programmed Stimulation Non-invasive Programmed Stimulation WARNING! Keep an external defibrillator available while using the NIPS function. The pulse delivery of implanted BIOTRONIK pacemakers can be externally controlled through the ICS 3000 via the properly positioned programming head. In such instances, the pacemaker is operating in a temporary standby mode.
32 Care and Maintenance Care and Maintenance WARNING! Changing the rechargeable battery Caution! Perform maintenance tasks only when the device is unplugged. Depleted rechargeable batteries can be replaced; contact BIOTRONIK. After a battery change, a complete battery maintenance cycle must be carried out so that the rechargeable battery reaches its full capacity and this can be displayed.
33 Sterilization Sterilization Caution! • Do not sterilize the ICS 3000! If you are conducting pacemaker programming under sterile conditions, operate the programming head with a sterile cover (see „Optional Accessories“ on page 40). Maintenance The ICS 3000 requires no maintenance. The following inspections must be carried out: Inspection A Before each use, check the following: • Visually examine the ICS 3000 and the programming head. • Check the housing and cables for mechanical damage.
34 Changing a Fuse Changing a Fuse The fuses are located in a fuse drawer below the connection for the power supply. Caution! Before changing the fuses, you must turn off the ICS 3000 and unplug the power supply cable. • To unlock the drawer, push the latches at the right and left of the drawer inwards together. • Pull the drawer out. • Replace the old fuses with new ones of the same type. The type of fuse is marked on the fuse itself; see also „Power Supply“ on page 38.
35 Technical Data Technical Data ICS 3000: General Information Dimensions [mm] Safety class 322*168*332 (W*H*D) I (DIN EN 60601-1, Section 5.
36 Technical Data LCD screen Type Size ["] TFT; color 12.1; active diagonal Resolution [dpi] 800*600; SVGA Brightness (programmable) 80 cd/m2; with battery operation (softwaredependent) 200 cd/m2; with battery operation (softwaredependent) ECG module: General Information Protection degree Power consumption [W] More BF, EN 60601-1, Section 5.2 0.
37 Technical Data Miniclinic Stimulation modes Pacing rate [ppm] Period [ms] Pulse width (A+V) [ms] Single- and multi-chamber 30 … 180; ±2 333 … 2000; 2 ±4 0,1 … 2,5; 0,05 ±0,05 AV conduction time [ms] 50 … 300; 2 ±4 Miniclinic Trigger level [mV] 2 … 150; 2 ±4 PGH Programming Head ICS 3000PGH Spiral cable, extendable to approx. 2.30 meters ICS 3000PGH Straight cable, 2.1 meters Straight cable, 2.
38 Technical Data Power Supply Type Mains voltage [V], Frequency [Hz] Safety class Fuse [A] Power [ W ] Primary clocked broadband power supply 100 – 115 V ± 10% / 60 Hz / 1.2 A / AC 220 – 230 V ± 10% / 50 Hz / 0.6 A / AC I, DIN EN 60601-1, Sec. 5.1 3.
39 Scope of Delivery Scope of Delivery Note: The software must be ordered separately. Standard Order number ICS 3000 Complete Complete system with accessories 336828 Complete system with accessories, with exclusively UL-certified components 349528 ICS 3000 Pen Stylus and holder 340295 ICS 3000PGH Spiral cable, extendable to approx. 2.
40 Optional Accessories Optional Accessories Order number M 50 Permanent magnet Magnetic flux density: 12.5 min. [mT] Dimensions: 60*17*26 (W*H*D) [mm] Weight: 0.185 kg ICS 3000PGH NK-11 / 3 m 112149 Straight cable, 2.1 meters 350103 Straight cable, 2.9 meters 355547 Power supply cord for the US; A PE conductor compliant with UL 2601-1; Device: Right-angle socket Power supply: Right-angle plug 128865 NK-16-GB / 2 meters Power supply cord for the United Kingdom 330705 NK-21-AU,UY / 2.
41 Country-Related Information Country-Related Information UL Certification The ICS 3000 US (order number: 349 528, ICS 3000 with Implant Module: 354 877) has been certified by Underwriters Laboratories Inc. in accordance with UL 2601-1 and CAN/CSAC22.2 No 601.1-M90. UL-certified devices are identified as follows: Distribution in the USA and Canada In the US and Canada, the device must be connected to a center-tapped power outlet if the voltage network carries 230 V at 60 Hz.
42 Electromagnetic Compatibility Electromagnetic Compatibility in Compliance with EN 60601-1-2:2002 • As the user, you must ensure that the ICS 3000 is operated in a suitable electromagnetic environment. The following guidelines may not be applicable in all cases. The propagation of electromagnetic values is, for example, affected by absorption and reflection by structures, objects and people. This data is for your personal information.
43 Electromagnetic Compatibility Recommended Safety Distances (Table 206) • Safety distances help prevent interference if you maintain a minimum distance between transmitters such as mobile RF telecommunication devices and the ICS 3000. The necessary distance depends on the respective power output of the transmitter. Note: At 80 MHz and at 800 MHz, the higher frequency range applies.
44 Electromagnetic Compatibility Resistance to Electromagnetic Interference (Tables 202 and 204) • When the measured field strength exceeds the specified compliance level at the operating location of the ICS 3000, observe the device in order to determine whether it is functioning properly. • If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
45 Electromagnetic Compatibility Test of Interference Resistance Test Level According to IEC 60601-1-2 Compliance Guidelines for the Electromagnetic Environment Magnetic field at the supply frequencies (50/60 Hz) 3 A/m Same as test • Ensure that the magnetic level field strengths are at levels characteristic of a location in a typical commercial and/or hospital environment. According to IEC 61000-4-8 Note: At 80 MHz and at 800 MHz, the higher frequency range applies.
46 Symbol Index Symbol Index Follow the instructions for use! Operation Module On/Off button Button for displaying the battery level Safe program button Emergency shock button ECG input with a BF degree of protection, defibrillation-proof Connection for the PGH 3000 programming head with a B degree of protection Programming Head Safe program button on the PGH 3000 programming head Position indicator on the PGH 3000 programming head
47 Symbol Index Docking Station USB port, only for devices approved by BIOTRONIK Serial port ON switch, for switching on the system even when the battery is fully depleted Mains 100-115 V~; 60 Hz; 1.2 A 220-230 V~; 50 Hz; 0.6 A 3.
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49 Index Index A Accessories, optional ................................................ 40 Adhesive and clip electrodes, approved ................... 40 Analog telemetry....................................................... 31 B Bluetooth interface ................................................... 22 C Calling up and triggering an emergency shock ....... 30 Calling up and triggering the safe program ............. 30 Care ...........................................................................
50 Index M Maintenance .............................................................. 33 Miniclinic ............................................................. 28, 37 N Non-invasive programmed stimulation.................... 31 O Operation Module...................................................... 21 Operation Module, symbols ...................................... 46 Operation Module, technical data ............................. 35 Overmodulation...................................................
