EP Cather Cables Summary of Validated Cleaning and Sterlization Methods

BACKGROUND Abbott (formerly St. Jude Medical) published cleaning and sterilization methods for many of our St. Jude Medical™ brand electrophysiology catheter cables in 2015. This letter replaces the past communication (SJM-AFGEN-0914-0007.) Please be aware that the exact same information on cleaning and sterilization of our cables is in each Instructions for Use (IFU) that is packaged with each cable. Please refer to the IFU accompanying the product when in doubt. Please take note that for all of the listed cables, the maximum number of uses, regardless of the sterilization and cleaning method combination used, is 10. You will be able to determine which methods are applicable to each individual cable based on the information provided in this document. The appendix in this document lists all St. Jude Medical brand cables affected by this change, as well as detailed cleaning and sterilization instructions.

QUESTIONS AND ADDITIONAL INFORMATION: If you have any questions regarding this change, please contact your local Abbott Representative or local Abbott Customer Service.

2 | Summary of Validated Cleaning and Sterilization Methods for St. Jude Medical™ Brand EP Catheter Cables

APPENDIX

EtO

STERRAD

Auto-clave

EP EXT CBL 20-pole, 150 cm (for Reflexion

Yes

Yes

Yes

No

EP EXT CBL 2/3/4-pole, 150 cm, black

Yes

Yes

Yes

No

EP EXT CBL 6-pole, 150 cm, black

Yes

Yes

Yes

No

401972

EP EXT CBL 6/8/10-pole, 150 cm, black

Yes

Yes

Yes

No

401973

EP EXT CBL 2/3/4-pole, 150 cm, blue

Yes

Yes

Yes

No

401974

EP EXT CBL 2/3/4-pole, 150 cm, grey

Yes

Yes

Yes

No

401975

EP EXT CBL 2/3/4-pole, 150 cm, red

Yes

Yes

Yes

No

401976

EP EXT CBL 6/8/10-pole, 210 cm, black

Yes

Yes

Yes

No

401977

EP EXT CBL 6/8/10-pole, 150 cm, red

Yes

Yes

Yes

No

401980

EPS EXT CBL 2/3/4-pole, 150 cm, black

Yes

Yes

Yes

No

401981

EPS EXT CBL 2/3/4-pole, 150 cm, blue

Yes

Yes

Yes

No

401982

EPS EXT CBL 2/3/4-pole, 150 cm, grey

Yes

Yes

Yes

No

401983

EPS EXT CBL B2/3/4-pole, 150 cm, red

Yes

Yes

Yes

No

401984

EPS EXT CBL 6-pole, 150 cm, black

Yes

Yes

Yes

No

401985

EPS EXT CBL 8/10-pole, 150 cm, black

Yes

Yes

Yes

No

401986

EPS EXT CBL 8/10-pole, 210 cm, black

Yes

Yes

Yes

No

402558

SAF EXT CBL to EPT-1000‡ XP, 150 cm

Yes

Yes

Yes

No

402560 SAF EXT CBL to IBI-1500T™ & Ampere™

Yes

Yes

Yes

No

402561

SAF EXT CBL to IBI-1500T & Ampere gen.,

Yes

Yes

Yes

No

402566

SAF EXT CBL to Stockert EP-Shuttle™, 150

Yes

Yes

Yes

No

402567

SAF EXT CBL to Stockert EP-Shuttle, 300

Yes

Yes

Yes

No

402505 EPTC EXT CBL to Stockert EP-Shuttle, 300

Yes

Yes

Yes

No

402543

EPTC EXT CBL to IBI-1500T & Ampere

Yes

Yes

Yes

No

402544 EPTC EXT CBL to IBI-1500T & Ampere

Yes

Yes

Yes

No

85735

1735-D EXT CBL to IBI-1500T & Ampere

No

Yes

Yes

No

85930

1910-S EXT CBL 10-pole, 150 cm

Yes

Yes

Yes

Yes

85931

1924-S EXT CBL 20/24-pole, 150 cm

Yes

Yes

Yes

Yes

85942

1910-S EXT CBL 10-pole, 250 cm

Yes

Yes

Yes

Yes

85945

1914-SA EXT CBL 14-pole, 210 cm

Yes

Yes

Yes

Yes

85953

1904-SA EXT CBL 4-pole, 150 cm

Yes

Yes

Yes

Yes

85954

1910-SA EXT CBL 10-pole, 150 cm

Yes

Yes

Yes

Yes

85955

1914-SA EXT CBL 14-pole, 250 cm

Yes

Yes

Yes

Yes

85201

2101-C EXT CBL for 1400-CV, 240 cm

No

Yes

Yes

No

85205

2102-C EXT CBL for 1400-CV II, 240 cm

No

Yes

Yes

No

Reorder number

Auto-wash

The section below provides updated cleaning and sterilization methods for the following cable model numbers. Manual cleaning and the sterilization with EtO and STERRAD‡ systems are applicable to all cables as described below. Please observe the limited applicability of the auto wash cleaning method and the autoclave sterilization method for individual cables.

Cables for Response™, 401661 Reflexion™ and Livewire™ 401970 diagnostic catheters 401971

Cables for Supreme™ diagnostic catheters

Cables for Safire™ dry tip ablation catheters

Cables for Livewire™ TC ablation catheters

Cables for Inquiry™ diagnostic catheters

Cables for Inquiry™ cardioversion catheters

Abbott Medical Australia Pty Ltd | 3

Auto-wash

EtO

STERRAD

Auto-clave

85641

1641 EXT CBL to IBI-1500T & Ampere™

No

Yes

Yes

No

85644

1641-A EXT CBL to IBI-1500T & Ampere gen., 250 cm

Yes

Yes

Yes

Yes

85711

1711-M EXT CBL to Medtronic ATAKR‡, 250 cm

No

Yes

Yes

No

85713

1713-W EXT CBL to Stockert EP-Shuttle™, single thermocouple, 250 cm

No

Yes

Yes

No

85739

1739-W EXT CBL to Stockert EP-Shuttle, dual thermocouple 250 cm

No

Yes

Yes

No

85763

1763-E EXT CBL to EPT-1000‡ XP, 4mm-tip thermistor, 250 cm

No

Yes

Yes

No

85778

1778-E EXT CBL to EPT-1000‡ XP, 8mm-tip thermistor, 250 cm

No

Yes

Yes

No

85643

1689 EXT CBL to Osypka, dual thermocouple, 250 cm

No

Yes

Yes

No

85708

1711-MA EXT CBL to Medtronic ATAKR‡, 250 cm

Yes

Yes

Yes

Yes

85709

1713-WA EXT CBL to Stockert EP-Shuttle, single thermocouple, 250 cm

Yes

Yes

Yes

Yes

85761

1761-W EXT CBL to Stockert EP-Shuttle, 4mm-tip thermistor, 250 cm

No

Yes

Yes

No

85809

1804-S St. Jude Medical™ Generators to Recording System

Yes

Yes

Yes

Yes

85684

1684-TH EPT Thermistor EXT CBL to IBI- 1500T, 250 cm

No

Yes

Yes

No

85719

1719-W Biosense Webster Thermocouple EXT CBL to IBI-1500T, 250 cm

No

Yes

Yes

No

85760

1760-M Medtronic Thermocouple EXT CB to IBI-1500T, 250 cm

No

Yes

Yes

No

85762

1762-W Biosense Webster Thermistor EXT CBL to IBI-1500T™, 250 cm

No

Yes

Yes

No

85764

1764-W Biosense Webster Dual Thermocouple EXT CBL to IBI-1500T, 250

No

Yes

Yes

No

85769

1769-BS Bard Thermistor EXT CBL to IBI-1500T, 250 cm

No

Yes

Yes

No

A402892

1611 EXT CBL to EnSite™ Contact™ Hardware Kit, 250 cm

No

Yes

Yes

No

Reorder number Cables for Therapy™ & Safire™ irrigated ablation catheters Cables for Therapy™ ablation catheters

EP Monitor cable Cable for non-St. Jude Medical ablation catheters

Cable for St. Jude Medical Contact Enabled™ catheters

4 | Summary of Validated Cleaning and Sterilization Methods for St. Jude Medical™ Brand EP Catheter Cables

Auto-wash

EtO

STERRAD

Auto-clave

D-AVSECBL12

Sensor Enabled™ Diagnostic Catheter Cable 12-Pin

Yes

Yes

Yes

Yes

Cable for Advisor HD Grid, Sensor Enabled™ Diagnostic Catheter Cables

D-AVSECBL22

Sensor Enabled™ Diagnostic Catheter Cable 22-Pin

Yes

Yes

Yes

Yes

Cable for FlexAbility Sensor Enabled™ Ablation catheters

A-FASECBL4

Sensor Enabled™ Ablation Connection Cable

Yes

Yes

Yes

Yes

Reorder number Cable for Advisor Fixed Loop Sensor Enabled™ catheters

Abbott Medical Australia Pty Ltd | 5

CABLE REUSE »P  roperly clean and re-sterilize cables within twentyfour (24) hours after use. »D  o not submerge cables in an enzymatic detergent or water bath during transport. Avoid contact with contaminated equipment or instruments during cable transport. »C  ables are intended to be reused a maximum of ten (10) times. Discard cables that have reached this number of uses. » I nspect cables prior to reuse. Do not use cables if there is visible damage. Discard damaged cables. »E  nsure that the connection is secure between the cable and connecting equipment. Note: To ensure cables are properly cleaned and externally sterile, use the specified cleaning and sterilization methods/parameters. Deviations from the specified methods/parameters may result in reduced instrument life or inadequate cleaning or sterilization. If alternate methods/parameters are used, it is the customer’s responsibility to ensure cables are effectively cleaned and sterilized. The sterilization and cleaning methods listed in this manual are only valid when using properly installed, maintained, calibrated and compliant cleaning and sterilization equipment.

*Only applicable to select cables as indicated in the cable listing above in Autowash column. 6 | Summary of Validated Cleaning and Sterilization Methods for St. Jude Medical™ Brand EP Catheter Cables

CABLE CLEANING METHODS

MANUAL METHOD

1. S  oak the cable for five (5) minutes, fully submerged in ENZOL‡ enzymatic detergent (or equivalent), diluted according to the manufacturer’s recommendations with warm 31°–43° C (88°–110° F) tap water. Remove visible soil with a soft-bristled brush. 2. Rinse the cable with clean, warm, running tap water for a minimum of one (1) minute. 3. D  ry with a clean, lint-free cloth. 4. A  fter cleaning, visually inspect cables for any remaining soil or moisture. Repeat cleaning and/or drying if necessary. Note: Cable must be thoroughly dried before sterilization. AUTOMATED METHOD* Preparation for Automated Cleaning: Prior to putting cables in the washer/disinfector, perform the following steps to ensure that any organic matter on the cables is rehydrated. 1. S  oak the cable for one (1) minute, fully submerged in ENZOL‡ enzymatic detergent (or equivalent), diluted according to the manufacturer’s recommendations with warm 31°–43° C (88°–110° F) tap water. 2. R  emove visible soil with a soft-bristled brush. 3. Rinse the cable with clean, warm 31°–43° C (88°–110° F), running tap water for a minimum of one (1) minute. Automated Cleaning: 1. Load cables into a tray in a manner that is consistent with the manufacturer’s instructions. Do not place heavy objects on top of cables or place cables next to sharp objects during an automated cleaning cycle. Doing so may damage the cables. 2. S  et the automated washer/disinfector RELIANCE‡ 444 (or legally marketed equivalent) to the following settings prior to running the cleaning cycle: Note: No thermal disinfection is recommended. Cycle

Time

Water Temperature (Tap or Purified)

Detergent & Concentration

Pre-Wash

1 min

Cold/Warm ≈ 16°-43°C (61°- 110°F)

N/A

Enzymatic Wash

1 min 30 sec

Warm/Hot ≈ 43°-60°C (110°- 140°F)

PROLYSTICA‡ 2X concentrate enzymatic presoak and cleaner (or equivalent), diluted per manufacturer’s instructions

Wash

2 min 30 sec

Heated 60°-70°C (140°-158°F)

PROLYSTICA‡ 2X concentrate neutral detergent (or equivalent), diluted per manufacturer’s instructions

Final Rinse

1 min 30 sec

Heated 60°-70°C (140°-158°F)

N/A

Drying

1 hour

Air Temperature 70°-80°C (158°-176°F)

N/A

3. A  fter cleaning, visually inspect cables for any remaining soil or moisture. Repeat cleaning and/or drying if necessary.

Abbott Medical Australia Pty Ltd | 7

STERILIZATION METHODS ETO STERILIZATION

STERRAD‡ STERILIZATION SYSTEMS

Place cable into a breathable package suitable for EtO sterilization (e.g. TYVEK‡ pouch or equivalent). Load cables into chamber and run equipment in a manner that is consistent with the manufacturer’s instructions.

Ensure cables are thoroughly dried before loading into the STERRAD system to avoid a potential cycle cancellation. Package the cable per facility practice in an appropriately sized single pouch (e.g., TYVEK pouch or equivalent), tray, or container labeled as appropriate for the STERRAD hydrogen peroxide gas plasma systems. Do not overlap cables. Load cables into STERRAD system and run equipment in a manner that is consistent with the manufacturer’s instructions.

St. Jude Medical has validated the following cycle parameters: Cycle Parameters

55°C Temperature Cycle

Pre-Conditioning Chamber Pre-Conditioning Time

30-45 min

Relative Humidity

40%-80%

Ethylene Oxide (EtO) Process

The following STERRAD‡ systems and cycles are recommended for reprocessing: STERRAD™ System and Cycle within the United States

STERRAD™ System and Cycle outside United States

STERRAD™ 50

STERRAD™ 50

STERRAD™ 200

STERRAD™ 200 (Short Cycle)

Exposure Time

1 hour

Vacuum Set

1.3 psia

Eto Gas

100% EtO

Eto Concentration

725 mg/L-880 mg/L

STERRAD™ 100S

STERRAD™ 100S (Short Cycle)

12 hours

STERRAD™ NX™ (Standard cycle)

STERRAD™ NX™ (Standard cycle)

STERRAD™ 100NX™ (Standard cycle)

STERRAD™ 100NX™ (Standard cycle)

Aeration Time

8 | Summary of Validated Cleaning and Sterilization Methods for St. Jude Medical™ Brand EP Catheter Cables

STEAM AUTOCLAVE Only applicable to select cables as indicated in the cable listing above in Autoclave column. The cables must be handled in the same manner as other reusable instruments that require packaging or wrapping during sterilization. All cables must be sterilized in packaging that is permeable to steam. Load cables and run equipment in a manner that is consistent with the manufacturer’s instructions. St. Jude Medical has validated the following cycle parameters: Temperature Cycle Cycle Parameters

Low

High

Dynamic/Pre-Vac Temperature

121°C (250°F)

132°C-135°C (270°F-275°F)

Time

40 min

4 min

Gravity Displacement Temperature

121°C (250°F)

132°C-135°C (270°F-275°F)

Time

40 min

10 min

Note: Sterilization temperatures must not exceed 135°C (275°F).

Abbott Medical Australia Pty Ltd | 9

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Abbott Abbott Medical Australia Pty Ltd 299 Lane Cove Road, Macquarie Park NSW 2113 Australia Tel: 1800 839 259 Abbott Medical New Zealand Limited 4 Pacific Rise, Mt Wellington Auckland 1060 New Zealand Tel: 0800 756 269 Abbott.com ™Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner. © 2023 Abbott. All Rights Reserved. MAT-2302365 v2.0 | Item approved for Australia and New Zealand use only.