User Guide
78 Pages
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User Guide
Care and Cleaning Information for the BK Ultrasound Product Range
English BB1564-AE February 2016
For Professional Users Only
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 CaviCideare trademarks of Metrex Cidexand 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 Interceptwipes 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
5
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
7
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
8
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.
Care and Cleaning (BB1564-AE)
Chapter 1: Warnings and Cautions
9
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
10
Never autoclave the transducers; this will damage them.
February 2016
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.
Care and Cleaning (BB1564-AE)
Chapter 1: Warnings and Cautions
11
12
February 2016
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
13
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.
February 2016
Care and Cleaning (BB1564-AE)
Type BF
BF: Isolated from ground Maximum patient leakage current under • Normal condition 100A • Single-fault condition 500A
Type BF
BF, defibrillator-proof.
Type B
B: Maximum patient leakage current under • Normal condition 100A • Single-fault condition 500A
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
15
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.
February 2016
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.
Care and Cleaning (BB1564-AE) Chapter 2: Markings on the Systems, Transducers and Accessories
17
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February 2016
Care and Cleaning (BB1564-AE)
Chapter 3: Introduction & Safety
Care and Cleaning (BB1564-AE)
Chapter 3: Introduction & Safety
19
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
20
Federal law in North America restricts this equipment to sale or use by or on the order of a physician.
February 2016
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
Care and Cleaning (BB1564-AE)
Chapter 3: Introduction & Safety
21