Patient Cable for Catheter Connector Technical Manual

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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.

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Other Technical Manuals It is essential to adhere to the technical manuals of other parts of the system that are not supplied with the device (such as measuring station, external devices, patient cables, adapters, leads, catheters).

Ambient Conditions Temperature Relative humidity Atmospheric pressure Operation at altitudes

Operation Storage and shipping Operation Storage and shipping 700 – 1060 hPa Up to 3000 m

10 - 40°C 0 - 50°C 25 to 95% (no condensation) 30 to 75% (no condensation)

Cleaning and Disinfection Manual cleaning and disinfection • Use a mild agent that is either alcohol based (e.g., a mixture of 70% isopropanol and 30% water), aldehyde based (e.g., Lysoformin® 2000) or based on quarternary compounds (e.g., Korsolex® plus). Machine cleaning and disinfection • Use an alkaline detergent (e.g., neodisher® MediClean forte). Please follow the instructions for use given by the manufacturer of the detergent or disinfectant.

Sterilization • Sterilize with steam: - 20 min hold at 121°C and 1.1 bar - 5 min hold at 134°C and 2.2 bar Note: 20 resterilization cycles are permitted. • Adhere to the permissible environmental conditions during storage.

Disposal Dispose of the accessories as medical waste in an environmentally friendly and proper manner.

Safety Warnings W WARNING Electric shock Touching the patient cable during defibrillation may endanger people involved in the procedure. • Do not touch the patient cable during defibrillation. W WARNING Malfunction of the patient cable Damaged or wet patient cables may result in malfunction and pose a risk to the patient. • Visually check the patient cable prior to usage. • Do not use damaged patient cables. • Do not use wet patient cables. W CAUTION Allergic reaction The material of the patient cable may trigger allergic reactions in extremely rare cases. • Prevent the adapter from contacting the skin or wounds. W CAUTION Loss of patient cable function Modifications to the patient cable may result in loss of function and thereby pose a risk to the patient. • Never modify the patient cable. W CAUTION Signal distortions Sources of electromagnetic interference may distort the signals and thereby pose a risk to the patient. • Do not operate the devices in the close vicinity of strong sources of interference. • Check the plausibility of the signals displayed. • Monitor the patient permanently using an external surface ECG with rate control.

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Packaging The patient cable is sealed in a blister sterilized using ethylene oxide. It is delivered in a box with a quality control seal. Both have labels stating product information such as model type, technical data, lot number, use by date, as well as information on sterility and storage. To ensure sterility, check the sterile container for damage prior to opening. If sterility is in question, please contact BIOTRONIK.

Opening the Package • In a non-sterile area - Remove the blister from the box. • In a sterile area - Open the blister and remove the patient cable.

Handling Step 1 2

3 4 5 6

Action Insert the Redel plug of the patient cable into the Redel port of the heart stimulator. Please observe the technical manual of the device. Connect the touch-proof 2-mm plugs of the catheters or the measuring station to the connector ports of the patient cable. Ensure that all contacts are correctly connected and refer to the technical manuals for the appropriate BIOTRONIK heart stimulator. Affix the patient cable using the clip (back of the housing) so that no tensile force is applied to the catheters or to the cable which is connected to the measuring station and the heart stimulator. Carry out the desired electrophysiological studies. After completing the electrophysiological studies, remove the patient cable from the port of the heart stimulator. When doing this, pull on the lead connector, not the cable. Remove the 2-mm plugs of the catheter or measuring station and remove the clip for attaching the patient cable.

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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 Patient cable PK-128

P

Patient

Sterilized with ethylene oxide Follow the instructions for use

Contents

Do not use if packaging is damaged

European approval mark Manufacturer

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

Technical Data Length Weight Applied part classification

2.8 m (± 0.05 m) 200 g ± 10% Type CF, defibrillation protected (in combination with a heart stimulator by BIOTRONIK)

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© BIOTRONIK SE & Co. KG

All rights reserved. Specifications subject to modification, revision and improvement.

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16-D- Revision: B (2016-08-15)

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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