Care and Cleaning User Guide Feb 2016

LEGAL MANUFACTURER BK Medical ApS Mileparken 34 2730 Herlev Denmark Tel.:+45 4452 8100 / Fax:+45 4452 8199 www.bkultrasound.com Email: [email protected] The serial number of a BK Ultrasound product contains information about the year 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 Ultrasound Customer Satisfaction Input from our customers helps us improve our products and services. As part of our customer satisfaction program, we contact a sample of our customers a few months after they receive their orders. If you receive an email message from us asking for your feedback, we hope you will be willing to answer some questions about your experience buying and using our products. Your opinions are important to us. You are of course always welcome to contact us via your BK Ultrasound representative or by contacting us directly. If you have comments about the user documentation, please write to us at the email address above. We would like to hear from you. © 2016 BK Ultrasound Information in this document may be subject to change without notice.

Trademarks: • • • • • • • • • • • • • • • • • • • • • • • • •

3E-Zyme is a trademark of Medisafe UK Limited Adaspor Single Shot is a registered trademark of Cantel Medica (Italy) S.R.L. Advantage Plus is a registered trademark of MEDIVATORS Inc. Bomix plus is a registered trademark of BODE Chemie GmbH Cavi Wipes and CaviCideare trademarks of Metrex Cidexand Nu-Cidex are registered trademarks of Advanced Sterilization Products (ASP) Cleanisept Wipes Forte is a registered trademark of Dr. Schumacher GmbH Gigasept FF is a registered trademark of Schülke & Mayr GmbH Intercept detergent and Interceptwipes are registered trademarks of MEDIVATORS Inc Korsolex is a registered trademark of BODE Chemie GmbH Meliseptol is a registered trademark of B. Braun MetriCide is a trademark of Metrex Mikrobac Tissues is a registered trademark of BODE Chemie GmbH neodisher and neodisher endo are registered trademarks of Chemische Fabrik Dr. Weigert GmbH & Co. KG Rely+On is a trademark of Du Pont Rapicide is a registered trademark of MEDIVATORS Inc Revital-Ox Resert is a registered trademark of the STERIS Corporation Sani-Cloth is a registered trademark of PDI Sekusept is a registered trademark of Echolab A/S SYSTEM 1 and 1E are registered trademarks of the STERIS Corporation STERRAD 100S, NX and 100NX are trademarks of ASP thermosept is a registered trademark of Schülke & Mayr GmbH Tristel is a registered trademark of Tristel Solutions Ltd Trophon is a registered trademark of Nanosonics Ltd V-PRO is a registered trademark of the STERIS Corporation

Contents Chapter 1: Warnings and Cautions... 7 Warnings... 8 Cautions... 9

Chapter 2: Markings on the Systems, Transducers and Accessories... 13 Chapter 3: Introduction & Safety... 19 Introduction... 20 Warnings, Cautions, Notes... 20 General Safety... 20 The bk3000/bk5000/bk3500 System and UA2361 Remote Control... 21 The Flex Focus 1202 System and UA1237 Remote Control... 21 Pro Focus UltraView 2202 System... 22 BK Transducers (E14C4t as an example)... 22 Transducer Care and Maintenance... 23 Inspection... 23 Service and Repair... 23 Storing Transducers When Not in Use... 23 Operating and Storage Environment... 24 Covers and Gels... 26 Transducer Covers... 26 Gels... 27 Using Sterile Covers on a System... 27

Chapter 4: Reprocessing Information and Methods... 29 General Information... 30 Levels of Reprocessing... 31 General Precautions... 31 Protecting Transducer Plugs during Immersion... 31 Reprocessing Equipment... 33 Pre-Cleaning (Point-of-Use Processing)... 34 Leakage Testing... 34 Thorough Cleaning... 35 Manual Disinfection... 36 Reprocessing Other Accessories... 37 Accessories Used for Puncture... 37 Accessories Not Used for Puncture... 37 Cleaning and Disinfecting the System... 38 Reprocessing Remote Controls... 39 Cleaning Remote Controls... 40 Disinfection/Sterilization... 40 Cleaning the Barcode Reader... 41 Automatic Reprocessing Methods... 42 Automated Endoscope Reprocessor – Medivators® Advantage Plus... 42 STERIS SYSTEM 1 Models... 43 STERRAD Systems... 44 STERIS V-PRO Systems... 45 Autoclaving... 46 English source version BB1564-AE

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Chapter 5: Checking and Maintaining Ultrasound Equipment... 47 Check of Equipment Between Each Use... 48 Transducers 2052, 20R3 and 8838... 49 Transducer 8666-RF, 8809, X18L5s and I12C4f... 49 Checking the Plug and Watertight Protection Devices Before Immersion... 49 Checking the Transducer for Leakage... 50 Leakage Testing Kits... 53 Yearly Preventive Maintenance and Performance Test... 53 Yearly Check of Type BF Transducers... 54

Chapter 6: Watertight Protection Devices... 55 Watertight Plug Lids... 56

Chapter 7: Disposal... 59 Appendix: Reprocessing Information and Tables... 61 Approved Disinfectants... 62 Transducer Compatibility... 62 Product Manufacturers... 63 Validated Reprocessing Methods for flex Focus/bk3000/bk3500/ bk5000 Systems... 64 Validated Reprocessing Methods for the bk3000/bk3500/bk5000 Transducer Series . . . 65 Material Compatible Reprocessing Methods for the bk3000/bk3500/bk5000 Transducer Series... 66 Validated Reprocessing Methods for the Flex Focus and Pro Focus Transducer Series . 67 Material Compatible Reprocessing Methods for the Flex Focus and Pro Focus Transducer Series... 68 Material Compatible Reprocessing Methods for Guides and Attachments... 69 Reprocessing Methods for Remote Controls UA1237 and UA2361... 70 Overview of InstruSafe Instrument Protection Trays for BK Devices... 71 Reprocessing Table for Craniotomy Transducer 8862 and Burr-Hole Transducer 8863 . 72 Reprocessing Information for Neurosurgical Transducers 8862 & 8863... 73 Index... 77

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Chapter 1: Warnings and Cautions

Care and Cleaning (BB1564-AE)

Chapter 1: Warnings and Cautions

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Warnings WARNING T-w5 Keep plug dry

To maintain safe operation, the connector pins in the transducer plug must always be completely dry. Be especially careful to check that they are dry and that the socket is dry before you connect to a system. WARNING Reproc-w1

Transducer and holder or container must be clean

Be particularly careful to clean the transducer before you put it into any sort of container for storage or transport so that you do not contaminate the container. To avoid cross-contamination, also make sure that a transducer holder or storage container is clean before you put a clean transducer into it. WARNING TC-w1

Latex sensitivity

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 latex-sensitive patients and be prepared to treat allergic reactions promptly. 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 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 CJ-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 Check-w2

Damage and reprocessing

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Equipment may be damaged by use or 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.

February 2016

Care and Cleaning (BB1564-AE)

WARNING Reproc-w3 Immediately after use, you must pre-clean the device until visually clean (including device lumens if existing). Conduct the thorough cleaning process as soon as possible after use in order to prevent bioburden drying on the surface. Dried bioburden can lead to inefficient cleaning, disinfection and sterilization, causing a risk of cross-contamination. if pre- and thorough cleaning cannot be done immediately, keep the device moist until cleaning.

Pre-clean immediately after use

WARNING RC-w1 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.

Remote Control

WARNING STERIS-w1 If a transducer has a built-in channel of any sort, you must use a STERIS Quick Connect to make sure that the solution gets into the channel. Contact your local STERIS representative.

Quick Connect for channels

WARNING Check-w1 To ensure safe operation, do not use the equipment if you find any signs of damage. Contact your BK service representative.

Do not use damaged equipment

If a transducer is dropped, and even if it shows no visible signs of damage, BK recommends that a High Voltage test is conducted before the transducer is used again. WARNING Check-w3 All transducers that comply with Safety Standard EN60601-1 (IEC60601-1) Type BF must be checked once a year to ensure that they still comply with the requirements of this standard. Transducers that need to be checked have the letters BF or the symbol printed on them.

Check of Type BF transducers

This check must be carried out by qualified personnel. Contact your BK service representative if you need any help checking your transducers. WARNING D-w1 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.

Contaminated items

Cautions Caution Rx-c1 Physician required in USA

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

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Chapter 1: Warnings and Cautions

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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 damaging equipment, be careful when you handle it. • Don't bump it on hard surface or drop it. Equipment dropped on a hard surface probably cannot be repaired. • Don't step on a cord or run over it with the wheels of the system. Caution TC-c3

Gels

Use only water-based gel (sterile if you are using a sterile transducer cover). Products containing parabens, petroleum or mineral oils may harm the transducer or transducer cover.

Caution Reproc-c1 Only approved methods

All reprocessing methods described in this book may not apply to all equipment. To prevent damage to a device, use only reprocessing methods that are recommended for that device. 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, before you immerse the transducer and plug in any liquid, cover the plug with the watertight protection device. 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 autoclave transducers

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Never autoclave the transducers; this will damage them.

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Care and Cleaning (BB1564-AE)

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 Plug-c5

Tighten screws with caution

Fully tightening one screw before tightening the other one, or having the lid on crooked while you tighten the screws, can damage the threads in the screw holes. 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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Care and Cleaning (BB1564-AE)

Chapter 2: Markings on the Systems, Transducers and Accessories

Care and Cleaning (BB1564-AE) Chapter 2: Markings on the Systems, Transducers and Accessories

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Symbol

Name

Description

Analogic logo

Caution or Warning

Consult accompanying user guide when you encounter this sign on the instrument, to avoid reducing its safety.

Consult instructions for use Consult user guide or other instructions.

14

CE Mark

Complies with EEC Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices.

Rx only

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

China ROHS 25 Years Lifetime

Environmentally Friendly Use Period for ROHS is 25 years.

Recycle symbol for corrugated cardboard

Corrugated cardboard for recycling.

WEEE waste

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

Manufacturer

Legal manufacturer.

Manufacturer’s catalog number

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

Serial number

Manufacturer’s serial number for the specific device.

Batch code

Manufacturer’s batch or lot number for a product.

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Care and Cleaning (BB1564-AE)

Type BF

BF: Isolated from ground Maximum patient leakage current under • Normal condition 100A • Single-fault condition 500A

Type BF

BF, defibrillator-proof.

Type B

B: Maximum patient leakage current under • Normal condition 100A • Single-fault condition 500A

Sealing

Dust-protected. 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.

Do not reuse

Single-use device. Do not try to process for reuse. Reuse can result in cross-contamination or can compromise the function of the product.

STERILE

Device is in a sterile condition.

STERILE EO

Device has been sterilized using ethylene oxide.

Do not resterilize

Do not resterilize. Resterilization can cause degradation of the materials and compromise the function of the product.

Non-sterile

Device is not in a sterile condition.

Contains latex.

Contains natural rubber latex or latex is present.

IP57

Not made with natural rub- Not made with natural rubber latex. ber latex

Care and Cleaning (BB1564-AE) Chapter 2: Markings on the Systems, Transducers and Accessories

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Do not use if package or label is damaged

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

Keep dry

Keep away from sunlight

16

Temperature limitation

Keep temperature between the upper and lower limits listed.

Atmospheric pressure limitation

Indicates the range of atmospheric pressure to which the medical device can be safely exposed.

Humidity limitation

Keep relative humidity between the upper and lower limits listed.

Date of manufacture

Date device was manufactured (4 digits for year, 2 digits for month).

Use by

Last date on which a marked item can be used: expiration date (4 digits for year, 2 digits for month).

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.

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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Care and Cleaning (BB1564-AE)

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

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

Table 1.

Markings on the system, transducers and accessories.

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Care and Cleaning (BB1564-AE)

Chapter 3: Introduction & Safety

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Chapter 3: Introduction & Safety

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Introduction This user guide contains information about caring for and reprocessing BK Ultrasound 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 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

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

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Care and Cleaning (BB1564-AE)

The bk3000/bk5000/bk3500 System and UA2361 Remote Control bk3000/bk5000

bk3500

monitor cap transducer barcode reader touch screen

transducers holders

keyboard

control panel

cable holder and release handle

trackball

transducer sockets CPU

lockable wheels

The Flex Focus 1202 System and UA1237 Remote Control

monitor & CPU cap keyboard

CD Drive

trackball control panel

backpack

printer

lockable wheels

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Chapter 3: Introduction & Safety

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