Autoclavable Internal Handles with Integrated Paddles Operators Guide Rev P

Operators Guide

21 Pages

Table of Contents Degree of Protection Against Electrical Shock ...i Symbols Used on the Equipment ... i Service ...i ZOLL Autoclavable Internal Handles with Integrated Paddles ...1 Indications for Use ...1 Using the Internal Handles with R Series Defibrillators ...1 Potential Adverse Effects ...2 Types of Internal Handles with Integrated Paddles Sets ...2 Cleaning and Disinfection ...3 Selection of Appropriate Paddle Size ...10 Verification of Operation Prior to Each Use ...10 Defibrillation Procedure...12 Three Month Checkout Procedure...13 Six Month Checkout Procedure ...14 Ordering Additional Parts...15

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Operator’s Guide

Autoclavable Internal Handles with Integrated Paddles

9650-0550 Rev. P

The issue date for the Autoclavable Internal Handles with Integrated Paddles Operator’s Guide (REF 9650-0550 Rev. P) is February, 2022. Copyright © 2022 ZOLL Medical Corporation. All rights reserved. ZOLL, R Series and X Series are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and in other countries. All other trademarks and registered trademarks are the property of their respective owners. Propaq is a registered trademark of Welch Allyn, Inc.

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA USA 01824-4105 ZOLL International Holding B.V. Newtonweg 18 6662 PV ELST The Netherlands ZOLL Medical Switzerland A.G. Bahnhofstrasse 20 6300, Zug Switzerland

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Table of Contents

Degree of Protection Against Electrical Shock ...i Symbols Used on the Equipment ... i Service ...i ZOLL Autoclavable Internal Handles with Integrated Paddles ...1 Indications for Use ...1 Using the Internal Handles with R Series Defibrillators ...1 Potential Adverse Effects ...2 Types of Internal Handles with Integrated Paddles Sets ...2 Cleaning and Disinfection ...3 Selection of Appropriate Paddle Size ...10 Verification of Operation Prior to Each Use ...10 Defibrillation Procedure...12 Three Month Checkout Procedure...13 Six Month Checkout Procedure ...14 Ordering Additional Parts...15

ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED PADDLES

Degree of Protection Against Electrical Shock

UDI

The ZOLL Autoclavable Internal Handles with Integrated Paddles are classified as Type CF, Defibrillator Protected equipment.

Symbols Used on the Equipment Any or all of the following symbols may be used in this manual or on this equipment:

Type B patient connection.

Type BF patient connection.

Type CF patient connection.

Indicates a carrier that contains Unique Device Identifier information. Indicates the entity importing the medical device into the locale.

Notification of Adverse Events As a health care provider, you may have responsibilities under the Safe Medical Devices Act (SMDA) for reporting to ZOLL and possibly to the Food and Drug Administration (FDA), the occurrence of certain events. These events, described in 21 CFR Part 803, include device related death and serious injury or illness. In any event, as part of our Quality Assurance Program, ZOLL should be notified of any device failure or malfunction. This information is required to assure that ZOLL provides only the highest quality products. If any serious incident has occurred in relation to the device, the incident should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Defibrillator-proof type BF patient connection.

Service

Defibrillator-proof type CF patient connection.

Should the ZOLL Internal Handle set require service, contact ZOLL Medical Corporation at 1-800-348-9011 or 1-781-229-0020.

ATTENTION Refer to manual for more information

You will be given a Return Service Request number under which to return the ZOLL Internal Handles. Send the unit in its original packaging or equivalent to:

Fusible Link.

For customers

Return the unit to

In the U.S.A.

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105

Protective (earth) ground terminal.

U.S.A. Customers

Attention: Technical Service Department (SR number)

Equipotentiality

Telephone: 1-800-348-9011 In Canada DANGER High voltage present

ZOLL Medical Canada Inc. 1750 Sismet Road, Unit #1 Mississauga, ON L4W 1R6 Attention: Technical Service Department (SR number)

Alternating current.

Telephone: 1-866-442-1011 DANGER Risk of explosion if used in the presence of flammable anesthetics Conformité Européenne Complies with the Medical Device Directive 93/ 42/EEC.

Indicates the item is a medical device.

In other locations

The nearest authorized ZOLL Medical Corporation representative. To locate an authorized service center, contact the International Sales Department at ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 Telephone: 1-978-421-9655 i

OPERATOR’S GUIDE For additional information on the product, its preparation for use, cleaning, sanitizing, sterilizing or other questions on infection control procedures for this product, please contact ZOLL Technical Service at 1-800-348-9011 or 1-781-229-0020. International Customers Should the ZOLL Internal Handles require service, they should be returned, in their original container or equivalent, to the nearest authorized ZOLL Medical Corporation service center.

ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED PADDLES

ZOLL Autoclavable Internal Handles with Integrated Paddles Indications for Use The ZOLL Autoclavable Internal Handles with Integrated Paddles are intended for use by a physician or trained medical personnel familiar with treating cardiac arrest in an emergency room or operating room setting. A clinician is required to manually place the electrode paddles in direct contact with a patient’s heart during an open chest procedure when a victim of suspected cardiac arrest has an apparent lack of circulation as indicated by absence of pulse or signs or circulation. The ZOLL® Autoclavable Internal Handles with Integrated Paddles are designed for use with ZOLL X Series®, Propaq® MD, and R Series® defibrillators to defibrillate the heart during open chest surgical procedures. ZOLL defibrillators equipped with an advisory ECG analysis feature will only operate as manual defibrillators when the internal handles are attached. The Operator’s Guide for your ZOLL defibrillator must be used in conjunction with this guide. Notes: 

This manual describes the use of the ZOLL Autoclavable Internal Handles with Integrated Paddles only. For instructions related to the use of other ZOLL internal handles, see the applicable Operator’s Guide.

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Cleaning and sterilization protocols for other ZOLL internal handle sets differ significantly and instructions in the applicable Operator's Guide must be followed.

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The ZOLL Autoclavable Internal Handles with Integrated Paddles are intended for use by or under the direction of a physician.

Using the Internal Handles with R Series Defibrillators The use of the Autoclavable Internal Handles with Integrated Paddles with R Series defibrillators is subject to the following restrictions when used in a 220/240 VAC 50 Hz or 60 Hz power environment:

WARNING DO NOT OPERATE AUTOCLAVABLE INTERNAL HANDLES, REF 8011-0139-xx (with 10 ft. cable), in 220/240 VAC 50 HZ OR 60 HZ POWER ENVIRONMENTS. The use of these internal handles in a 220/240 VAC 50 HZ OR 60 HZ power environment may result in unacceptably high leakage currents and compromise patient safety. To use Autoclavable Internal Handles with Integrated Paddles with a ZOLL R Series Defibrillator in a 220/240 VAC 60 Hz environment, you must use only the Autoclavable Internal Handles with Integrated Paddles, REF 8011-0141-xx (with 7 ft. cable), with the ZOLL One-Step Cable (REF 1009-0913-01) or ZOLL Multifunction (MFC) Cable (REF 1009-0913-03).

OPERATOR'S GUIDE

Potential Adverse Effects Potential adverse effects (e.g. complications) associated with use of Internal Handles include:    

Failure to deliver a defibrillation shock Bystander shock from patient contact during defibrillation Interaction with ICDs (pacemakers) Infections, burns and mechanical damage

Types of Internal Handles with Integrated Paddles Sets The Internal Handles with Integrated Paddles Sets are available in two styles (shown below). Style A internal handles (REF 8011-0139-xx and REF 8011-0141-xx) include a button on the apex handle whose activation initiates discharge of the attached defibrillator. Style B internal handles (REF 8011-0140-xx) do not include a discharge button. Discharge of the defibrillator is affected by the depression of the front panel SHOCK button when using Style B internal handles. Please note that both internal handle styles are available with several different integrated paddle/spoon sizes. See the “Ordering Additional Parts” table at the end of this manual to determine the appropriate value of –xx, shown in these part numbers.

Style A Internal Handles with Discharge Button

ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED PADDLES

Style B Internal Handles without Discharge Button Connection of the internal handle set to the appropriate defibrillator automatically causes the unit to limit its energy output to a maximum of 50 Joules. The internal handle set can be sterilized by autoclaving according to the guidelines provided in this document.

Cleaning and Disinfection NOTES: 

The following process for cleaning and sterilization of the Autoclavable Internal Handles with Integrated Paddles has been validated to be effective in the disinfection of these products. Product users are responsible for qualifying any deviation from this recommended method of processing.



All cleaning agents should be prepared and used according to the manufacturer's instructions and product labeling.

Follow local protocols for disposing contaminated devices. Do not allow the internal handle sets to dry after use and before cleaning (more than 4 hours). Items contaminated with blood and/or other protein materials cannot be effectively cleaned if allowed to dry. The Internal Handle Set (including the connector) and Integrated Paddles may be immersed, if necessary, during cleaning. The connector cap can be removed. The handle set must be hand washed or machine washed. Do not subject them to ultrasonic washing machines. To ensure the integrity of the internal handle set, perform a functional test prior to each use (see "Verification of Operation Prior to Use"). Do not disassemble the internal handle sets. Any attempt to disassemble the internal handle sets will void any applicable warranties.

OPERATOR'S GUIDE The Internal Handle with Integrated Paddles can be sterilized by either Steam Sterilization in a Pre-Vacuum Autoclave according to the guidelines provided in this document or by the STERRAD® 100S/NX Sterilization System.

CAUTIONS  The Autoclavable Internal Handles with Integrated Paddles are sold and shipped in a non-sterile condition. They should be cleaned and sterilized following the procedures outlined below prior to their first use and after each reuse.  Do not drop, bump or knock the internal paddles. Damage to the insulating coating of the paddle may occur.  Inspect each internal paddle after cleaning and prior to each use for: 1. Nicks or burrs that may injure patient tissue 2. Scratches, pits, or gouges in the paddle surface 3. Loose or damaged insulating coating 4. Cracks in the paddle’s overmolded plastic 

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

 

If any of these conditions are observed, remove the handle set from use. Autoclavable Internal Handles with Integrated Paddles are constructed from high quality materials. The severe conditions of sterilization, however, will limit their useful life. Thus, the useful life of the internal handle set is limited primarily by the frequency of sterilization rather than the age of the internal handle set. Inspect the Handles frequently for signs of deterioration such as cracks, crazing, damaged cables, and damaged switch covers. Replace if deterioration is noted. Do not clean the handles in ultrasonic cleaners. Hand or machine wash only. Do not expose the handles to any product containing organic solvents such as acetone, ketones, chlorinated hydrocarbons or aromatic hydrocarbons. Exposure to these solvents may degrade the handle materials. Keep the connector as free from contamination as possible. The connector may be immersed and cleaned with the rest of the assembly (with the cap removed), but it is difficult to clean properly because of its shape and function. The Connector cap must remain in place at all times to protect the contact sockets, except when in use and during cleaning. Repeated sterilization cycles may cause the cable insulation to blister or bubble. This is considered normal and will not affect the function of the internal handle set. Replace the internal handle set if the cable insulation is cracked or cut.

In the following sections we describe the procedures to follow for both Manual Washing and Mechanical Washing.

ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED PADDLES

MANUAL WASHING METHOD AND STERILIZATION The handles, paddles, cable connector and connector cap must be thoroughly cleaned prior to each sterilization. Follow his procedure for manual washing ZOLL’s internal handles with integrated paddles: 1. ZOLL recommends the use of Enzol enzymatic detergent. Prepare the enzymatic detergent as recommended by the manufacturer’s product labeling, e.g. solution temperature (18-22 ºC, 64-71 ºF) and concentration (29.57 mL to 3.79 L or 0.78% concentration). Submerge the handle set in a tub or basin sufficiently sized to accommodate the device and submerge in enzymatic detergent. Scrub with a medium-sized soft bristled brush. Soak for 5 minutes. Note: It is recommended that a brush with a ½ inch (1.2 cm) diameter be used for cleaning the internal cavities. Following the soak period, scrub the handles, paddles, cable connector, and connector cap again with a soft bristled brush. Visually inspect the handles, paddles, cable connector, and connector cap for cleanliness. If necessary, repeat the process above. The handles, paddles, cable connector, and connector cap must be free of any visible contamination prior to rinsing. 2. Rinse Rinse the handles, paddles, cable connector, and connector cap for at least 30 seconds under running water. When rinsing the Internal Handles, be sure to rinse the cable connector, connector cap and the handle end thoroughly. If the manufacturer of the cleaning agent recommends a rinse protocol, this should be followed. 3. Air Dry Allow the handles, paddles, cable connector, and connector cap to air dry for 6 hours prior to wrapping for sterilization. Air drying may be performed in a drying oven whose temperature does not exceed 120º C (250º F) for a maximum duration of 30 minutes.

Inspection Inspect the clean handles, paddles, cable connector, and connector cap for any residual contaminants. Inspect the internal handle set for signs of deterioration such as cracks, crazing, damaged cables, connector pins or switch covers. Repeated sterilization cycles may cause the cable insulation to blister or bubble. This is considered normal and will not affect the function of the handle set. Replace the handle set if the cable insulation is cracked or cut. Inspect the paddles for damaged insulating coating, or other mechanical damage such as: scratches, pits, gouges, nicks or burrs that may injure patient tissue. If any of these conditions are observed, remove the Internal Handle Set from use.

OPERATOR'S GUIDE

Securing the Connector Cap Attach the connector cap, located on the cable of the internal handle set, securely to the cable connector (Refer to Figure 1). The connector cap must remain in place at all times to protect the contact sockets, except when in use and during cleaning.

Sterilization

Figure 1

Steam Sterilization Wrap: Before wrapping the Internal Handle with Integrated Paddles sets, be sure the cable is coiled with a diameter larger than 6 inches (15 cm). Never wrap the cables around the handles. This may hinder proper sterilization. Wrap the internal handles and paddles in a sterile pouch according to your wrapping procedures. Sterilize: Sterilize the wrapped Internal Handles with Integrated Paddles using a Pre-Vacuum Steam Autoclave. The autoclave cycles should have one of the following characteristics: Autoclave Cycle Characteristic

Pre-Vacuum (Wrapped) Standard Cycle #1

Pre-Vacuum (Wrapped) Standard Cycle #2

Pre-Vacuum (Wrapped) Optional Long Cycle (May be used instead of Standard Cycle)

Sterilization Temperature

132.2º – 137º C (270º – 278.6º F)

134⁰ C – 137⁰ C (273.2⁰ F – 278.6⁰ F)

132.2º – 137º C (270º – 278.6º F)

Sterilization Exposure Time

4 – 5 minutes

3 minutes, 15 seconds

18 – 20 minutes

Drying Time

10 – 12 minutes

25 minutes

20 – 30 minutes

When using hand washing, the Internal Handles with Integrated Paddles are capable of withstanding 100 steam sterilization cycles. After sterilization, store devices in sterile wrap at room temperature until use. STERRAD ® 100S/NX Hydrogen Peroxide Gas Plasma Sterilization Method The Internal Handles with Integrated Paddles are capable of withstanding 100 STERRAD 100S/NX cycles. Wrap: Before wrapping the Internal Handle with Integrated Paddles sets, be sure the cable is coiled with a diameter larger than 6 inches (15 cm). Never wrap the cables around the handles. This may hinder proper sterilization. Wrap the internal handles and paddles in sterile wrapping sheets according to your wrapping procedures. Sterilize: Sterilize the wrapped Internal Handles with Integrated Paddles using the STERRAD 100S or NX equipment.

ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED PADDLES When using Hand Washing, the Internal Handles with Integrated Paddles are capable of withstanding 100 STERRAD 100S/NX cycles. Note: Ensure that the Internal Handles are wrapped properly before sterilization.

MECHANICAL WASHING METHOD AND STERILIZATION ZOLL’s internal handles with integrated paddles have been validated for mechanical washing using either the Hamo LS-1000 mechanical washer or the Getinge Series 86 Washer. Washer cycle parameters for the Hamo LS-100 or equivalent Treatment

Time (mm:ss)

Temperature

Pre Wash