Biotronik

Patient Cable for Catheter Connector Technical Manual

20 Pages

427850--B_GA_PK-128_en-es-fr-pt.book Page 3 Monday, August 15, 2016 5:10 PM  en • English  Table of Contents Intended Medical Use... 3 Technical Description... 3 Target Group... 3 Other Technical Manuals... 4 Ambient Conditions... 4 Cleaning and Disinfection... 4 Sterilization... 4 Disposal... 4 Safety Warnings... 4 Packaging... 5 Opening the Package... 5 Handling... 5 Legend for the Label... 6 Technical Data... 6  Intended Medical Use The patient cable PK-128 is used to connect a measuring station or BIOTRONIK diagnostic catheters to one of the following BIOTRONIK heart stimulators: • Qubic Stim • UHS 3000 The patient cable PK-128 is used for transmission of intrinsic events and pacing pulses for diagnostics in the context of electrophysiological studies in a cardiac catheter laboratory. The following precautionary measures must be maintained while conducting electrophysiological studies. • Use in suitable rooms with X-ray and security equipment including an emergency pacemaker and an external defibrillator. The patient cable PK-128 has been sterilized with ethylene oxide and can be sterilized with steam up to 20 times.  Technical Description The patient cable PK-128 has a 6-pin Redel plug on the device side. On the patient side, PK-128 has six connector ports with spring contacts for touch-proof 2-mm plugs. On the back of its housing, PK-128 has a clip for attaching the cable, for example to a surgical drape. The connector ports Sense 3 (+) and Sense 3 (-) are not supported by Qubic Stim. To pace on the third channel in addition to channels 1 and 2 using the Qubic Stim, you must connect a second PK-128 to patient cable connection "3" and connect the catheter to "Channel 1" of the PK-128 patient cable. Labeling on the cable Qubic Stim UHS 3000 Channel 1 / DIFF (–) Different and indifferent pole of pacing and sensing Different and indifferent pole of pacing and sensing Channel 1 / INDIFF (+) channel 1 and 3 channel 1 Channel 2 / DIFF (–) Different and indifferent pole of pacing and sensing Different and indifferent pole of pacing and sensing channel 2 Channel 2 / INDIFF (+) channel 2 Sense 3 (-) Not supported Reference potential for input Sense 3 (+) Sense 3 (+) Not supported The signal of the sensing channel can be measured against an input INDIFF (+) or against Sense 3 (-).  Target Group This technical manual is intended for cardiologists, electrophysiologists and heart surgeons possessing knowledge in the following areas: • Catheterization procedures • Intracardiac stimulation and conduction systems This technical manual is also intended for clinical and technical assistants possessing expertise in handling devices in cardiac catheter laboratories.  en • English  3
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File Name: Biotronik - 427850 - Patient Cable for Catheter Connector Technical Manual - 2016-08 - Rev B.pdf

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