Biotronik

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

18 Pages

398940--C_GA_PK-142_en-es-fr-pt.book Page 1 Thursday, March 2, 2017 8:40 PM  en • English  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  1  398940--C
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File Name: Biotronik - 398940 - Patient cable for IBI-1500T7, IBI-1500T11 and Ampere Technical Manual - 2017-03 - Rev C.pdf

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