Patient cable for IBI-1500T7, IBI-1500T11 and Ampere Technical Manual

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Table of Contents Safety while Handling... 1 Technical Product Description... 1 Intended Use... 1 Connecting the System to Other Devices... 2 Caution for Leakage Currents... 2 Cleaning... 2 Disinfection... 2 Sterilization... 2 Disposal... 2 Handling... 2 Connections... 3 Operation... 3 Technical Data... 3 Permissible Ambient Conditions... 3 Legend for the Label... 4

Safety while Handling W WARNING Risks of improper handling Failure to observe the safety precautions voids all damage claims and manufacturer liability. • Please refer to the technical manuals for the external devices and ablation catheters to be used in conjunction with this device.

Technical Product Description The cable is shielded and has a blue covering. It has non-interchangeable, coded and self-locking Redel plugs. The plugs are resistant to dripping water and marked with an indelible inscription. Patient side, with blue kink protection:

Pin configuration, arrangement of contacts: Plug side Pin 1 = tip Pins 2-4 = poles 2, 3, 4 Pin 5, 6 = NC Pin 7 = TC constantan Pin 8 = NC Pin 9 = TC common Device side, with yellow kink protection:

Pin configuration, arrangement of contacts: Plug side Pin 1 = TC common Pin 2 = TC constantan Pin 3-10 = NC Pin 11 = pole 4 ALCath Pin 12 = pole 3 ALCath Pin 13 = pole 2 ALCath Pin 14 = tip AlCath

Intended Use Patient cables are used for transmission of sensing signals and pacing pulses for diagnostics and therapy in the context of intracardiac examinations. Electrophysiological therapy of the heart requires the use of cardiac catheters. The precautionary measures, as described in the literature, must be observed during examinations and ablation procedures. PK-142 is intended to connect an ablation catheter equipped with a thermocouple of ALCath and Trignum and a BIOTRONIK Qubic Force external device to an RF generator IBI 1500 (version T7, software v.2.4 and version T11, software v.3.0) and Ampere (software v.1.0.4) from St. Jude Medical. The connection to a different ablation system is not permitted. Patient cables may only be used by healthcare professionals who are qualified for intracardial examinations and therapy. Patient cables may not be physically modified, e.g., be shortened. Precautionary measures must be maintained while conducting intracardial examinations and therapies: • Use in suitable rooms with X-ray equipment and security equipment including emergency pacemaker and external defibrillator. Continuous monitoring by a physician with an external ECG device is required. en • English

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Connecting the System to Other Devices See: • Intended Use, p. 1 • Safety while Handling, p. 1 Note: EMC conformity of this cable is warranted for the specified device (see Intended Use, p. 1). You will find information on electromagnetic compability in its technical manual. W CAUTION Signal distortions Sources of electromagnetic interference may distort the signals and thereby pose a risk to the patient. • Do not operate devices in the close vicinity of strong sources of interference. • Check the plausibility of the signals displayed.

Caution for Leakage Currents Leakage currents between all connected devices, the cable and the patient (i.e. the myocardium) must be prevented if line-powered devices have to be used in the vicinity of the patient. Such leakage currents may trigger lethal arrythmias, especially in case of an accumulation. • Instructions concerning the use of electromedical devices according to national and international regulations apply to patient cables as well. These instructions have to be complied with. • All devices operated in the ablation system must be connected to the potential equalization in accordance with their technical design.

Cleaning Clean and rinse with the following agents: • Cleaning agents with a pH-value of 4-10; follow manufacturer’s instructions • Distilled water Permissible cleaning methods: • Machine cleaning with a maximum washing temperature of 93°C and a maximum drying temperature of 120°C; follow manufacturer's instructions • Manual cleaning by using a brush • Application time ≤ 1 h

Disinfection Follow manufacturer's instructions for application time but do not soak for longer than one hour. Disinfect with one of the following agents: • Aerodesin® 2000 • Fugaten® Spray • Aldasan® 2000 • Mixture of 70% isopropanol and 30% water Dry the cable carefully at a maximum of 120°C.

Sterilization • Pack the cable in the applicable sterile container, according to the respective sterilization procedure. • Sterilize with steam: - 5 min hold at 134°C and 2.2 bar - 20 min hold at 121°C and 1.1 bar Note: 50 resterilization cycles are permitted. • Follow permissible ambient conditions for storage.

Disposal The product may be properly disposed of as contaminated hospital medical waste after use.

Handling Preparations The sterility cannot be guaranteed if the sterile packaging has been damaged or improperly handled or stored. • Examine the sterile packaging for damage before opening it. Do not use a non-sterile patient cable. • Properly remove the sterile patient cable from the blister. • Visually check the patient cable prior to use; do not use in case of obvious defects or damage. • Check that the connector ports and plugs are clean and dry. • Re-sterilize before each reuse.

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Connections W CAUTION Do not force the plugs into the connector port.

W CAUTION Connect the patient only after the entire system has been switched on. PK-142 → RF generator IBI-1500T7, IBI-1500T11, Ampere Device side Redel plug

Ablation connection of the generator

Redel-1P, 14-pin, coding 0°, male, yellow

Redel-1P, 14-pin, coding 0°, female, yellow

PK-142 → AlCath, Trignum ablation catheters W CAUTION Allergic reaction The adapter material may trigger allergic reactions in extremely rare cases. • Prevent the adapter from coming in contact with skin or wounds. W WARNING If there is direct electrical contact with the myocardium, improper handling of the touch-proof plugs may cause severe complications such as ventricular fibrillation.

Patient side Redel plug Redel-1P, 9-pin, coding 60°, male, blue

Connection to AlCath, Trignum Redel-1P, 9-pin, coding 60°, female, blue

Operation W WARNING Do not touch the patient cable during defibrillation!

W WARNING Do not use damp cables! Precautionary measures • A catheter that is connected to the ablation system but is not in use must be disconnected from the device. • The patient cable must not have contact with the patient or other (ECG) leads. Maximum output values • Maintain the catheter's limits regarding maximum load; see the technical manuals for the connected catheters. • Take the temperature measuring accuracy of the entire system into account. Checking the values • Monitor the actual values and signals for plausibility in order to quickly detect possible cable defects. Separating the connections • Release the patient cable from the external device's connector and from the ablation catheter without pulling on the cable.

Technical Data Patient cable PK-142/ 2.5 m, sterile Applied part classification Length Degree of protection Device connection Patient connection Packaging

Order number: 362442 Type CF 2.5 m IP 20 Redel-1P, 14-pin, coding 0°, male, yellow Redel-1P, 9-pin, coding 60°, male, blue Sterile cable in blister and box

Permissible Ambient Conditions

Temperature Relative humidity Atmospheric pressure

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Operation 10-40°C 25-95%, no condensation 500-1,060 hPa

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Storage 0-50°C 30-75%, no condensation

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Legend for the Label Symbol

Meaning Manufacturing date

Use by

Temperature limit for storage

Air pressure limit for storage

Humidity limit for storage

BIOTRONIK order number

Lot number

Sterilized with ethylene oxide

Follow the instructions for use!

Contents

Do not use if packaging is damaged

CE mark Caution: Federal (U.S.A.) law restricts this product to sale by, or on the order of, a physician.

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©B  IOTRONIK SE & Co. KG

All rights reserved. Specifications subject to modification, revision and improvement. All product names in use may be trademarks or registered trademarks held by BIOTRONIK or the respective owner.

0123 2010

1; Revision: C (2017-03-02)

BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin · Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 [email protected] www.biotronik.com

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