Care and Cleaning Information for the BK Medical Product Range

LEGAL MANUFACTURER BK Medical ApS Mileparken 34 2730 Herlev Denmark Tel.:+45 4452 8100 / Fax:+45 4452 8199 www.bkmedical.com Email: [email protected] The product label of a BK Medical product contains information about the date of manufacture. New disinfection and sterilization methods are constantly being developed, and we work to make our products compatible with as many methods as possible. You can find the latest information about caring for our products, including disinfection and sterilization compatibility, on our website. New information may have been added since you received this book.

BK Medical Customer Satisfaction Input from our customers helps us improve our products and services. Your opinions are important to us. You are always welcome to contact us via your BK Medical representative or by contacting us directly.

Incident Reporting Should any serious incident occur in relation to your BK Medical device, you should report this to the manufacturer and your local competent authority.

© 2022 BK Medical Information in this document may be subject to change without notice.

Contents Chapter 1: Warnings and Cautions... 7 Warnings... 8 Cautions... 10

Chapter 2: Markings on the Systems, Transducers and Accessories... 13 Safety Symbols and Information on the Equipment... 14

Chapter 3: Introduction & Safety... 19 Introduction... 20 Warnings, Cautions, Notes... 20 General Safety... 20 bkActiv and UA2370 Remote Control... 21 The bk3000/bk5000 and UA2361 Remote Control... 21 bkSpecto... 22 The Flex Focus 1202 System... 22 Battery-Powered Systems... 23 BK Transducers (E14C4t as an example)... 24 Care and Maintenance... 24 Inspection... 24 Service and Repair... 24 Storing Devices When Not in Use... 25 Operating and Storage Environment... 26 Covers... 27 Transducer Covers... 27 Using Sterile Covers on a System... 28

Chapter 4: Reprocessing Information and Methods... 29 General Information... 30 Levels of Reprocessing... 31 General Precautions... 31 Protecting Transducer Plugs during Immersion... 32 Reprocessing Transducers... 32 Use of Brushes and Sponges... 33 Pre-Cleaning Transducers (Point-of-Use Processing)... 33 Leakage Testing... 34 Cleaning and Disinfecting Transducers Automatically... 34 Cleaning Transducers Manually... 38 Disinfecting Transducers Manually... 40 Extra Information for Cleaning the Transducer N20P6... 41 Reprocessing Accessories... 41 Pre-cleaning Accessories... 41 Cleaning and Disinfecting Accessories Automatically... 43 Cleaning Accessories Manually... 44 Disinfecting Accessories Manually... 45 Sterilizing Accessories... 45 Specific Requirements for Accessories... 45 Cleaning and Disinfecting the System... 46

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Reprocessing Remote Controls UA2361 and UA2370... 47 Cleaning Remote Controls UA2361 and UA2370... 48 Disinfection/Sterilization... 48 Automated Reprocessing Methods... 49 Automated Endoscope Reprocessor – Medivators® Advantage Plus... 49 STERIS SYSTEM 1 Models... 50 STERRAD Systems... 51 STERIS V-PRO Systems... 52 STERIZONE VP4... 53 Matachana 130LF, Webeco FA90, Webeco FA95... 54 Steam Sterilization... 55

Chapter 5: Checking and Maintaining Ultrasound Equipment... 57 Recommended routine checks... 58 Check of Equipment Between Each Use... 59 Transducer IQ Test... 59 Transducers 20R3, 8838, and 2052... 60 Transducers 20R3, X14L4, 8838, and 2052... 60 Transducer 8666-RF, 8809, I12C4f, I13C3f, and X18L5s... 60 Checking the Plug and Watertight Protection Devices Before Immersion... 60 Checking the Transducer for Leakage... 60 Leakage Testing Kits... 64 Yearly Preventive Maintenance and Performance Test... 64 Yearly Check of Type BF Transducers... 65

Chapter 6: Watertight Protection Devices... 67 Watertight Plug Lids... 68

Chapter 7: Disposal... 71 Appendix: Reprocessing Information and Tables... 73 Approved Disinfectants... 74 Transducer Compatibility... 74 Product and Process Manufacturers... 75 Reprocessing Methods for bkActiv/ bk3000/ bk5000/ bkSpecto and Flex Focus Systems . 76 Validated Reprocessing Methods and Material Compatible Reprocessing Methods for the T7P2m (9027) Transducer... 77 Material Compatible Reprocessing Methods for bkFusion Hardware... 78 Validated Reprocessing Methods for bkActiv/ bk3000/ bk5000 and bkSpecto Transducer Series... 79 ... 80 Material Compatible Reprocessing Methods for bkActiv/ bk3000/ bk5000 and bkSpecto Transducer Series... 81 Validated Reprocessing Methods for the Flex Focus Transducer Series... 83 Material Compatible Reprocessing Methods for the Flex Focus Transducer Series... 84 Material Compatible Reprocessing Methods for Guides, Attachments and bkFusion Hardware... 86 Reprocessing Methods for Remote Controls UA2361 and UA2370... 87 Overview of InstruSafe Instrument Protection Trays for BK Devices... 88 Reprocessing Table for Craniotomy Transducer 8862 and Burr-Hole Transducer 8863 . 89 Reprocessing Information for Neurosurgical Transducers 8862 & 8863... 90

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CE-Marking Information... 93 Index... 95

An electronic copy of this document in the official language of your member state can be accessed through our website. English source version BB1564-BG

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Chapter 1: Warnings and Cautions

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BK Medical Care and Cleaning Guide

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Warnings WARNING T-w5 Keep plug dry

To prevent electrical shock and damage to the transducer, the connector pins in the transducer plug must always be completely dry before you connect to a system. WARNING Reproc-w1

Transducer, holder and container must be clean

To avoid contamination, clean transducers before inserting them into storage containers for transportation. To avoid cross-contamination, make sure that transducer holders and storage containers are clean before inserting clean transducers. WARNING Reproc-w2

Infection control – follow established procedures

Users of this equipment have an obligation and responsibility to provide the highest possible degree of infection control to patients, co-workers and themselves. The instructions in this book are meant as a guide. To avoid cross-contamination, follow all infection control policies (including for reprocessing, packing and storage) for personnel and equipment that have been established for your office, department or hospital. WARNING Reproc-w3

Pre-clean immediately after use

Immediately after use, you must pre-clean the device until visually clean (including any lumens). Conduct the thorough cleaning process as soon as possible after use in order to prevent soil drying on the surface. Dried soil can lead to inefficient cleaning, disinfection and sterilization, causing a risk of cross-contamination. WARNING Reproc-w4

Reprocessing

Extra care must be taken when cleaning this transducer, as there is no automatic cleaning system that can reprocess the entire transducer. WARNING Reproc-w5

Screen contamination

To avoid contamination of the speaker area, do not touch this area when you turn the monitor to the horizontal or vertical position. WARNING Reproc-w6

Automated cleaning and disinfection

BK device materials are not suitable to be processed with automated cleaning and disinfection processes, except for those devices stated as approved for automated cleaning and disinfection processes. To prevent damage to the device and risk for the patient, use only reprocessing methods recommended by BK Medical. WARNING TC-w1 Some transducer covers can contain latex. Because of reports of severe allergic reactions to medical devices containing latex (natural rubber), the FDA advises health-care professionals to identify their latex-sensitive patients and be prepared to treat allergic reactions promptly.

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WARNING TC-w2 Neurosurgical covers

For neurosurgical applications, use only non-pyrogenic, sterile probe sheaths (transducer covers) that are approved for neurosurgical use. This means that in the USA they must be market cleared by the FDA and in Europe they must be CE-marked. In Canada, they must be licensed by Health Canada. WARNING TC-w7 Use only approved non-pyrogenic, sterile transducer covers. This means that in the USA they must be market cleared by the FDA and in Europe they must be CE-marked. In Canada, they must be licensed by Health Canada. WARNING C-J-w1

CreutzfeldtJakob

Do not use a transducer for neurosurgical applications if the patient is suspected of having Creutzfeldt-Jakob disease. If a neurosurgical transducer has been used on a patient suspected of or diagnosed as being Creutzfeldt-Jakob positive, the transducer must be destroyed, following approved procedures for your hospital. WARNING RC-w1

Remote Control

The remote control requires surface disinfection or sterilization as a minimum. The inside battery compartment cannot be classified as disinfected or sterile. Follow procedures established for your hospital, clinic or institution to avoid cross-contamination when inserting or removing batteries. WARNING Check-w1

Do not use damaged equipment

To ensure safe operation, do not use the equipment if you find any signs of damage. Contact your BK service representative. If a transducer is dropped, and even if it shows no visible signs of damage, BK recommends that you call your BK service representative. They will check the transducer and perform appropriate testing for the type of damage that has occurred. WARNING Check-w2

Damaged and Reprocessing

Equipment may be damaged by use or incorrect reprocessing. It is important to check it at least once a month (or more often, if it undergoes sterilization) to ensure that it can be effectively reprocessed. If there are any pits or cracks on any equipment surfaces, reprocessing may not give a sterile or disinfected product and equipment can suffer internal damage as a result of misuse. WARNING Check-w3

Check of Type BF transducers

To prevent electrical shock, all transducers with a (BF) Body Floating symbol comply with Safety Standard IEC60601-1 for leakage currents. Check the transducer once a year to ensure that this quality is met consistently throughout the transducer’s lifetime. This check must be carried out only by qualified personnel. Contact your BK service representative if you need any help checking your transducers. WARNING D-w1

Contaminated items

(BB1564-BG) Issued 2023-12

For disposal of contaminated items such as transducer covers or needle guides or other disposable items, follow disposal control policies established for your office, department or hospital.

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Cautions Caution Rx-c1 Physician required in USA

United States law restricts this device to sale by or on the order of a physician.

Caution S-c1 Heat, dust, sunlight, condensation

To prevent damage to the system, avoid excessive heat, dust and direct sunlight. Also do not use the system if there is visible condensation on it. Wait until it reaches room temperature. Caution T-c1

Handle with care

To prevent damage, handle equipment carefully. • Don't strike or drop the transducer on a hard surface. Equipment dropped on a hard surface may not be repairable. • Don't step on a cord or run over it with the wheels of the system. Caution Plug-c1

Keep plug dry

To prevent damage to a transducer or system, protect the plug from contact with liquid. Caution Plug-c2

Immersion: Cover plug – Lid ON

To prevent damage to the transducer, cover the plug with the watertight protection device before you immerse the transducer and plug in liquid. Caution S-c2

Keyboard panel not watertight

The keyboard panel of the ultrasound system is not watertight. Be careful not to spill any liquids, gels or moist substances on the keyboard panel. Caution Plug-c3

Gas Processing: Do not cover plug Lid OFF

Do NOT use a watertight protection device with any form of gas processing. The transducer can be seriously damaged if a watertight protection device is used.

Caution Reproc-c2 Do not steam sterilize transducers

(BB1564-BG) Issued 2023-12

Never steam sterilize the transducers or remote control; this will damage them.

BK Medical Care and Cleaning Guide 10

Caution Plug-c4 Examine plug and waterproof protection for damage

Before you reprocess the transducer, inspect the watertight protection device and the transducer plug. If you find any signs of damage, do not immerse the plug. If liquid comes into contact with the plug connector pins, the transducer may be destroyed. Examine the edges of the plug case that contact the lid and also the watertight protection device for cracks and marks. Examine the rubber seal of the plug lid. Look for deep scratches and grooves, holes or tears, brittleness, and looseness anywhere. The transducer or watertight protection device must be checked by a BK service representative if you find signs of damage. Caution Test-c1

Test for leaks before immersing

You should use the leakage tester to test for leaks. If a transducer is not completely watertight, immersing it can seriously damage it. Caution Test-c4

Keep watertight plug lid dry

Do not let the watertight plug lid get wet during the testing procedure. Keep it out of the tank. If water gets inside the watertight plug lid, moisture can be transferred from the lid to the plug connector pins during reprocessing. This can damage the transducer. Caution Test-c3

Do not immerse if pressure drops

If the pressure drops to zero after you use the pump, do not place the transducer in the tank.

Caution Test-c5 If you see bubbles, do not release pressure

If you see any bubbles, remove the transducer from the tank before you release the pressure.

Caution Test-c2 Do not use test lid for reprocessing

The lid part of the leakage tester is for testing only. Do not use it when you reprocess the transducer. Caution: T-c5 Using a non-recommended disinfection solution, an incorrect solution strength or immersing a transducer longer than recommended by the disinfectant manufacturer can damage the transducer.

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Chapter 2: Markings on the Systems, Transducers and Accessories

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BK Medical Care and Cleaning Guide 13

Safety Symbols and Information on the Equipment Table 1 below contains brief explanations of the symbols and information used to label the equipment. The manufacturer disclaims all responsibility for the operating safety, reliability, and performance of the equipment if these symbols and warnings are disregarded in any way. Table 1 Markings on the system, transducers and accessories.

Symbol

Name

Description

CE Mark

The device complies with all required EU regulations and directives. The four digit number identifies the notified body.

Medical Device

Device used for medical purpose.

Rx only

Federal (U.S.A) law restricts sale of this device to physicians or other qualified medical professionals.

Manufacturer

Indicates the medical device manufacturer.

Consult instructions for use

Consult user guide or other instructions.

Do not use if package or label is damaged

Do not use if product sterilization barrier or its packaging is compromised.

Read the user guide or other instructions for Follow instructions for use important safety warnings.

(BB1564-BG) Issued 2023-12

Catalog number

For BK Medical, this is the “Type number” of a product.

Serial number

Manufacturer’s serial number for the specific device.

Quantity

The quantity of items contained in the package appears next to the symbol

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Table 1 Markings on the system, transducers and accessories.

Symbol

Name

Description

Date of manufacture

Symbol always accompanied by the date device was manufactured (4 digits for year, 2 digits for month, and 2 digits for day).

Type BF

BF: Isolated from ground.(Used on transducers.) Maximum patient leakage current under • Normal condition ≤100μA • Single-fault condition ≤ 500μA BF, defibrillator-proof.

Type BF B: Non- isolated from ground. (Used on transducers.) Type B

Maximum patient leakage current under. Normal condition ≤100μA • Single-fault condition ≤ 500μA •

IP57

ESD (electrostatic discharge)

Do not touch pins in connectors with this symbol unless you follow ESD precautionary procedures.

Specified Radio Equipment

(On remote control UA2361and UA2370). This equipment conforms to Japanese Radio Law regulations concerning frequency and power.

Ingress protection code

Protected from limited dust ingress. Protected against immersion up to 1 m.

Handle with care

The tip of the transducer is very delicate. Be very careful not to bump the tip. Instability during transport.

Warning: Do not push

Warning: Keep hands clear

(BB1564-BG) Issued 2023-12

Do not use excessive force to push the system. Excessive force when pushing over uneven surfaces can cause the system to overbalance and tip. Show caution when you adjust the system monitor.

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Table 1 Markings on the system, transducers and accessories.

Symbol

Name

Description

Maximum weight for system with accessories

Safe working load. The weight in kilos of the system including transducers.

Fragile, handle with care

Packing material indication. Indicates a medical device that can be broken or damaged if not handled carefully.

Transport dry

Keep away from sunlight

Packing material indication. Indicates a medical device that needs to be protected from light sources.

Tip N Tell

Tilt indicators. Note: Different models shown

This way up

Indicates transport orientation.

Do not stack

Indicates a medical device that should not be stacked.

STERILE

Device is in a sterile condition.

Sterilized using ethylene oxide.

Non-sterile

Contains latex.

(BB1564-BG) Issued 2023-12

Packing material indication. Indicates a medical device that needs to be protected from moisture.

Device has been sterilized using ethylene oxide. Device is not in a sterile condition.

Contains natural rubber latex or latex is present.

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Table 1 Markings on the system, transducers and accessories.

Symbol

Name

Description

Not made with natural rubber latex

Not made with natural rubber latex.

Temperature limit

Atmospheric pressure limitation

Humidity limitation

Storage and transport temperature: -20 °C to +60 °C Packing material indication. Keep temperature between the upper and lower limits listed (-20 °C to +60 °C) Storage and transport atmospheric pressure: 700 hPa to1060 hPa Packing material indication. Indicates the range of atmospheric pressure to which the medical device can be safely exposed. Storage and transport humidity: 20% to 80%. Packing material indication. Keep relative humidity between the upper and lower limits listed.

STERRAD – lid off

Watertight plug lid must not be attached during STERRAD processing.

Not watertight

Plug must not be immersed.

Immersion with cap on

Can be immersed if cap is tightened as indicated.

No immersion with cap off Must not be immersed if cap is off or not tightened.

(BB1564-BG) Issued 2023-12

Battery direction

Indicates battery direction AA LR6 1.5V

Lock-Unlock

On the watertight plug lid, indicating the locked and unlocked position for the locking pins that hold the lid onto the plug.

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Table 1 Markings on the system, transducers and accessories.

Symbol

Name

Description

Immersion Watertight plug lid must be attached during reprocessing – lid must be immersion. on

Gas reprocessing – lid must be off

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Watertight plug lid must not be attached during gas reprocessing or whenever pressure is below 700 hPa (10.2 psi).

Control of pollution

Environmentally Friendly Use Period for ROHS is 25 years.

China Recycle

Corrugated cardboard for recycling.

Crossed out wheeled bin

Within the EU, when you discard waste of electrical and electronic equipment, you must send it to appropriate facilities for recovery and recycling.

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Chapter 3: Introduction & Safety

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Introduction This user guide contains information about caring for and reprocessing BK Medical equipment. It includes important information about what you must do to ensure the safe and proper performance of the system, transducers and accessories. This includes information about cleaning, disinfection and sterilization. Follow established procedures

NOTE: The instructions below are meant as a guide. They describe the highest level

protocol for this level of reprocessing. Always follow the procedures that have been established for your hospital, clinic or institution, as well as any national guidelines.

Warnings, Cautions, Notes Pay attention to the difference between Warnings, Cautions and Notes. WARNING Warnings contain information that is important for avoiding personal injury. Caution Cautions contain information that is important for avoiding damage to equipment, data or software. NOTE: Notes contain other information that you should be aware of.

Please find a complete list of warnings and cautions starting on page 8.

General Safety Caution Rx-c1 Physician required in USA

(BB1564-BG) Issued 2023-12

Federal law in North America restricts this equipment to sale or use by or on the order of a physician.

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bkActiv and UA2370 Remote Control

monitor cap transducer

glass keyboard

release handle cable holder and transducers holders

control panel

CPU battery

lockable wheels

The bk3000/bk5000 and UA2361 Remote Control

monitor cap transducer

keyboard trackball

transducers holders

control panel

cable holder and release handle transducer sockets

CPU

lockable wheels

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