Patient cable for HAT 300 SMART Technical Manual

383664--D_GA_PK-111_en-es-fr-pt.book Page 3 Wednesday, July 27, 2016 1:45 PM

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Table of Contents Safety while Handling... 3 Technical Product Description... 3 Intended Use... 4 Connecting the System to Other Devices... 4 Caution with Leakage Currents... 4 Cleaning... 4 Disinfection... 4 Sterilization... 4 Disposal... 4 Handling... 5 Connections... 5 Operation... 5 Technical Data... 6 Permissible Ambient Conditions... 6 Legend for the Label... 6

Safety while Handling W WARNING Risks of improper handling Failure to observe the safety precautions voids all damage claims and manufacturer liability. • Please also observe the technical manuals of the external devices to be connected and of the ablation catheters.

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 touch-proof 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 Pins 5, 6 = NC Pin 7 = TC constantan Pin 8 = thermistor Pin 9 = TC/TM common Device side with blue kink protection:

Pin configuration, arrangement of contacts: Plug side Pin 1 = T1-1/Cu+ Pin 2 = T1-2/ConPins 3, 4 = NC Pins 5-7 = poles 4, 3, 2 Pin 8 = NC Pin 9 = tip

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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 ablations. The PK-111 is intended for the connection of ablation catheters of the AlCath andTrignum series and the BIOTRONIK Qubic Force external device to the external ablation device HAT 300 SMART ™ (version 2.01E / 2.14E). 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 modified technically, e.g., be shortened. Precautionary measures must be maintained while conducting intracardial examinations and therapies: • Use in suitable rooms with X-ray equipment, security equipment including emergency pacemaker and external defibrillator. Continuous monitoring by a physician with an external ECG device is necessary.

Connecting the System to Other Devices See: • Intended Use, p. 4 • Safety while Handling, p. 3 EMC conformity of the ablation system, within which the patient cable is operated, must be given. You will find information on electromagnetic compatibility in the respective technical manuals. 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 with Leakage Currents Leakage currents between all connected devices, the patient cable and the patient (i.e. the myocardium) must be securely prevented if linepowered 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. • If present, the potential equalization cables must be connected to all the devices operated with the patient cable.

Cleaning Clean and rinse with the following agents: • Cleaning agents with a pH-value of 4 to 10; note 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; note manufacturer's instructions. • Manual cleaning by using a brush • Application time ≤ 1 h

Disinfection Note manufacturer's data on application time, yet never soak > 1 h. 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: - 20 min hold at 121°C and 1.1 bar Note: 20 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.

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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. • Connector ports and plugs must be clean and dry. • Re-sterilize before each reuse.

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-111 → External device HAT 300 SMART Device side Redel plug Redel-1P, 9-pole, coding 0 °, male, blue

Ablation connection of external device Redel-1P, 9-pole, coding 0 °, female, blue

PK-111→ ablation catheter W CAUTION Allergic reaction The adapter material may trigger allergic reactions in extremely rare cases. • Prevent the adapter from contacting the skin or wounds. W WARNING At 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-pole, coding 60 °, male, blue

Connection to AlCath, Trignum Redel-1P, 9-pole, coding 60 °, female, gray

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 manual of 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 the cable.

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Technical Data Patient cables PK-111/ 2.0 m, sterile Applied part classification Length Degree of protection Device connection Patient connection Packaging

Order number: 330080 Type CF 2.0 m IP 20 Redel-1P, 9-pole, coding 0 °, male, blue Redel-1P, 9-pole, coding 60 °, male, blue Sterile cable in transparent blister and storage package

Permissible Ambient Conditions

Temperature Relative humidity Atmospheric pressure

Operation 10 - 40°C 25 to 95% (no condensation) 500 – 1060 hPa

Storage 0 - 50°C 30 to 75% (no condensation)

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

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

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© BIOTRONIK SE & Co. KG

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

0123 2001

16-D- Revision: D (2016-07-27)

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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