PK Electrode Clip Technical Manual

© BIOTRONIK 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.

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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Table of Contents

Table of Contents PK-222, PK-222-L, and PK Electrode Clip...

2

Intended Medical Use ...

2

Required Expertise ...

2

Expected Clinical Benefit...

2

Residual Risk ...

2

Technical Product Description ...

2

Safety during Use...

3

Cleaning and Disinfection...

5

Sterilization ...

6

Disposal...

6

Handling ...

6

Technical Data ...

7

Legend for the Label...

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PK-222, PK-222-L, and PK Electrode Clip Technical Product Description

PK-222, PK-222-L, and PK Electrode Clip Intended Medical Use The PK-222 patient cable (if applicable, with "PK Electrode Clip" patient cable electrode clips) or the PK-222-L patient cable is used with a surface ECG to connect the ECG electrodes to a programmer from BIOTRONIK. As part of implantations and follow-ups of implantable pacemakers, ICDs (implantable cardioverterdefibrillators), and implantable cardiac monitors from BIOTRONIK, the signals are transmitted via the patient cable for representation of the surface ECG on the screen.

Required Expertise The patient cable is intended for use by physicians, trained medical or technical hospital staff, and trained staff from BIOTRONIK. In addition to basic medical knowledge, a detailed knowledge of cardiac electrotherapy and training with the programmer are required. Only trained medical personnel with this knowledge can properly operate the patient cable.

Expected Clinical Benefit The patient cable and the programmer have a clinical benefit when used in combination with BIOTRONIK implantable pacemakers, ICDs, or implantable cardiac monitors (ICMs), as part of a medical device system. The clinical benefit is to enable the intended use of the implantable products.

Residual Risk The risk analysis carried out by the manufacturer's Risk Management team has determined that the residual risk is at the lowest possible level. Prerequisites for this are the intended use of a patient cable that has been serviced and inspected according to the manufacturer's specifications by qualified medical staff and compliance with the safety-relevant instructions in this technical manual.

Technical Product Description Device-side connection On the device side, the PK‑222 and PK‑222‑L patient cables have a yellow 14-pin Redel plug (P series, 40° coded).

Patient-side connection The PK-222 and PK-222-L patient cables are compatible with adhesive and clamp electrodes with snap connectors (see also Optional accessories [Page 7]). On the patient side, PK-222 has four color-coded 4 mm lamella-basket plugs (banana plugs) for extremity derivations according to Einthoven.

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PK-222, PK-222-L, and PK Electrode Clip Safety during Use

Patient cable electrode clips can be attached to the lamella-basket plugs of the PK-222. The electrode clips are available as optional accessory ("PK Electrode Clip", see also Optional accessories [Page 7]).

The PK-222-L has four color-coded and permanently mounted patient cable electrode clips on the patient side for extremity derivations according to Einthoven.

Color coding The assignment of the four color-coded 4 mm lamella-basket plugs or the patient cable electrode clips for extremity derivations according to Einthoven is as follows: Extremity

PK‑222 EU/2.8 m

PK‑222 US/2.8 m

PK‑222‑L ECG cable

PK‑222‑L ECG cable US

Right arm

R / red

RA / white

Left arm

L / yellow

LA / black

Left leg

F / green

LL / red

Right leg

N / black

RL / green

Safety during Use Disregarding the safety warnings can endanger the patient, the staff, and the equipment. Failure to observe the safety warnings voids all damage claims and manufacturer liability. The following dangers may arise in the event of improper use: •

Failure of important device functions

•

Personal endangerment due to electrical impact

Read these instructions carefully. Keep this technical manual for future reference.

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PK-222, PK-222-L, and PK Electrode Clip Safety during Use

Precautions WARNING Risk to the patient due to use of wet or damaged cables Damaged or wet cables may limit functionality and may pose a risk to the patient. •

Perform a visual inspection of the patient cable prior to use.

•

Never use wet or damaged cables.

•

Monitor the patient using an external surface ECG with rate control for the duration of the procedure.

WARNING Risk to the patient or user from electrical current induction into electrode connection parts during surface ECG When electric energy is introduced into the electrode connection parts of the patient cable, e.g., in the area of plugs or clips, this can cause skin injuries or arrhythmias. •

The patient-side plugs or clips of the patient cable must not be inserted into power plugs or other plug connections or be connected to them.

•

Attach the used electrode connection parts with patient-side plugs or clips firmly and securely to the patient.

•

Attach all unused electrode connection parts with plugs or clips firmly and securely in the proximity of the patient.

Attention Risk to the patient •

The PK-222 and PK-222-L patient cables and the patient cable electrode clips ("PK Electrode Clip") are non-sterile and cannot be sterilized. Follow the instructions on cleaning and disinfecting.

Attention Risk of electrical shock during defibrillation If, during defibrillation, you touch the patient, the device, and/or connected accessories to which the patient is attached, you may receive an electric shock. •

During defibrillation, do not touch the patient, the device the patient is connected to, and/or the attached accessories.

Caution Risk to the patient and loss of cable function if cable is modified •

Never modify the patient cable.

Caution Risk to the patient due to distorted signals. Electromagnetic interference may distort the signals. •

Do not place devices in the proximity of strong sources of interference.

•

Check the validity of the signals displayed.

Caution Risk to the patient due to misinterpreted signals •

Be careful to connect all contacts correctly when connecting the leads.

•

Monitor the patient using an external surface ECG with rate control for the duration of the procedure.

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PK-222, PK-222-L, and PK Electrode Clip Cleaning and Disinfection

Note Disregarding the safety instructions can endanger the patient, the staff, and the technical equipment. Failure to observe the safety instructions voids all damage claims and manufacturer liability. The following dangers may arise in the event of improper use: •

Failure of important device functions

•

Personal endangerment due to electrical impact

Read these instructions carefully. Keep this technical manual for future reference.

Note Connecting the system to other devices •

Electromagnetic compatibility (EMC) of this cable is warranted for the external devices of BIOTRONIK. You will find information on EMC in the respective technical manuals.

Note Conductive parts of electrodes and plugs or clips of the patient cable should not come into contact with other conductive or grounded parts.

Other technical manuals Please observe the technical manuals for the external devices, adapters, and leads. Please observe the technical manuals for the external devices, patient cables, and leads.

Cleaning and Disinfection You may use the following cleaning agents to manually clean the cables and patient cable electrode clips: •

Mild cleaning agents with a pH value of 4 ... 10

You may use the following active ingredient classes to manually disinfect the cables and patient cable electrode clips: •

Alcohol-based disinfectant

•

Hydrogen peroxide-based disinfectant

•

Quaternary compound-based disinfectant

The disinfection of the product was tested using the following agents: •

•

Alcohol-based disinfectant –

Mixture of 70% isopropyl and 30% water

–

Mixture of 85% ethanol and 15% water

–

Aerodesin 2000 (manufactured by Lysoform Dr. Hans Rosemann GmbH)

Hydrogen peroxide-based disinfectant –

•

2-percent solution for use with terralin® PAA (manufactured by Schülke & Mayr GmbH)

Quaternary compound-based disinfectant –

2-percent solution for use with terralin® protect (manufactured by Schülke & Mayr GmbH)

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PK-222, PK-222-L, and PK Electrode Clip Handling

For PK-222: Disconnect the patient cable electrode clips ("PK Electrode Clip") from the lamella-basket plugs before cleaning and disinfecting. 1. 2. 3. 4.

5.

Please follow the instructions for use given by the manufacturer of the detergent or disinfectant. Clean and disinfect the patient cables and the patient cable electrode clips thoroughly. After cleaning, visually inspect to check whether all impurities have been removed. If necessary, repeat the cleaning procedure. After cleaning and disinfecting, check the patient cables and the patient cable electrode clips for dryness. If necessary, dry them using a soft and lint-free cloth. Never use damp patient cables and patient cable electrode clips. After cleaning and disinfecting, check the patient cables and the patient cable electrode clips for damage. Never use damaged patient cables and patient cable electrode clips.

Sterilization Attention Risk to the patient •

The PK-222 and PK-222-L patient cables and the patient cable electrode clips ("PK Electrode Clip") are non-sterile and cannot be sterilized. Follow the instructions on cleaning and disinfecting.

Disposal The used product should be properly disposed of as contaminated hospital medical waste.

Handling Connecting and disconnecting the cable 1.

2.

3. 4. 5.

Insert the Redel plug of the patient cable into the Redel port of the programmer for the ECG connection. Refer to the technical manual of the programmer. For PK-222 only: Patient cable electrode clips ("PK Electrode Clip", see Optional accessories [Page 7]) can be plugged on the four color-coded 4 mm lamella-basket plugs (banana plugs). Connect the lamella-basket plugs or patient cable electrode clips to the adhesive or clamp electrodes of the patient. Ensure correct contact (see Color coding [Page 3]). Carry out the desired examinations. After completing your examination, disconnect the lamella-basket plugs or the patient cable electrode clips from the adhesive or clamp electrodes while opening the electrode clips. Pull the Redel plug out of the Redel port of the programmer. While doing so, detach the plug or the clip and do not pull on the cable.

Note The ECG connection can be terminated and reestablished while the programmer is still active.

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PK-222, PK-222-L, and PK Electrode Clip Technical Data

Retention Store the patient cable in a dry place (Ambient conditions [Page 7]). Please refer to the technical manual of the programmer for potential additional information on storing cables.

Technical Data PK‑222, PK‑222‑L Category

PK‑222 EU/2.8 m

PK‑222‑L ECG cable

PK‑222 US/2.8 m

PK‑222‑L ECG cable US

Length

2.8 m (± 0.1 m)

4.0 m (± 0.2 m)

Weight

160 g (± 10%)

200 g (± 10%)

Applied part classification

Type CF, defibrillation protected

Patient-side connection

4 color-coded 4 mm lamellabasket plugs (banana plugs)

Disclosure pursuant to Section 33 REACH, Regulation (EC) No. 1907/2006

See: https://www.biotronik.com/material-compliance

4 color-coded and permanently mounted patient cable electrode clips

Ambient conditions Category

Operation

Transport and storage

Temperature

10–40°C / 50–104°F

0–50°C / 32–122°F

Relative humidity

20–75%, no condensation

Atmospheric pressure

700–1060 hPa

Operation at altitudes

Up to 3000 m

Optional accessories Item designation

Description

Order no.

PK Electrode Clip

4 patient cable electrode clips

340293

H34 SG

Adhesive electrode; manufacturer: Kendall ARBO

T 60

Adhesive electrode; manufacturer: SKINTACT

Type 454 Type 460 G 502

Adhesive electrode; manufacturer: Dahlhausen Clamp electrode; manufacturer: GOLMED

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PK-222, PK-222-L, and PK Electrode Clip Legend for the Label

Legend for the Label Symbol

Meaning BIOTRONIK order number Lot number

Manufacturing date Medical device

Unique device identifier

Distributor

Acceptable temperature range for storage

Acceptable atmospheric pressure range for storage

Acceptable relative humidity range for storage

Patient

Manufacturer

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Contents

Follow the instructions for use!

CE mark This device contains material that requires special waste disposal according to the environmental protection guidelines. The European Directive 2012/19/EU on waste electrical and electronic equipment (WEEE 2) must be observed. Return devices that are no longer used to BIOTRONIK.

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PK-222, PK-222-L, and PK Electrode Clip Legend for the Label

Symbol

Meaning Total length

Quantity (in the package)

PK Electrode Clip

PK-222 PK-222-L