Datascope

Ultrasound Diagnostic Imaging Systems

Advanced Cleaning , Disinfection and Sterilization Guide Rev 19.0 Nov 2021

Guide

59 Pages

File Type: PDF

File Size: 2.36 MB

File Name: US Cleaning,Disinfection&Sterilization Guide_CE_V19.0_EN.pdf

Preview

Page 1

Ultrasound System

Cleaning, Disinfection & Sterilization Guide [Advanced]

Ultrasound system

Cleaning, Disinfection & Sterilization Guide [Advanced]

Thank you for the purchase of Mindray’s products. To ensure safe and proper operation of the system, read the guide carefully. Keep this guide carefully after reading, so that you can check it whenever necessary.

Issue date: 2021-11

Intellectual Property Statement © 2021 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All Rights Reserved. SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this document. Disclosure of the information in this guide in any manner without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation or translation of this guide, in any manner whatsoever without the written permission of Mindray, is strictly forbidden. , , , , , , BeneView, WATO, BeneHeart, are the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.

Statement Contents of this document are subject to changes without prior notice. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: •

All installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;

•

The electrical installation of the relevant room complies with the applicable national and local requirements and requirements of this guide;

•

The product is used in accordance with the instructions for use.

Table of Contents

Table of Contents Intellectual Property Statement... II Statement... II Important Information... 1 About this Guide... 1 Meaning of Signal Words... 1 1

General information about cleaning, disinfection and sterilization... 3 1.1

Safety Precautions...3

1.2

Brief Introduction to Materials...4 Plastics...4

1.2.2

Stainless Steel...5

1.2.3

Silica Gel...5

1.2.4

Epoxy Glue...5

1.2.5

Glass...5

Inspection Before and After Use... 7 2.1

Appearance Inspection...7

2.2

Performance Inspection...7

2.3

Use of Probe Sheath...7

2.4

Wearing the Probe Sheath...8

Cleaning, Disinfection and Sterilization for Non-TEE Probes... 9 3.1

Cleaning and Disinfection/Sterilization Overview...9

3.2

Selecting a Microbicidal Method...10

3.3

Cleaning...10

3.4

Disinfection... 11

3.5

1.2.1

3.4.1

Low-level disinfection of a non-critical probe... 11

3.4.2

High-level disinfection of a semi-critical probe...12

Sterilization of a critical probe...13

Cleaning and Disinfection of TEE Probe... 15 4.1

4.2

Cleaning...16 4.1.1

Compatible Detergents...16

4.1.2

Cleaning Procedure for TEE Probe...16

Disinfections...17

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

Table of Contents

Compatible Disinfectants...18

4.2.2

Disinfection Procedure...19

Cleaning and Sterilizing the Needle-guided Bracket... 21 5.1

Cleaning...21

5.2

Sterilization...22 5.2.1

Sterilization with a sterilant...22

5.2.2

High-pressure steam sterilization...22

Cleaning and Disinfection of Main Unit... 25 6.1

6.2

4.2.1

Cleaning...25 6.1.1

Cleaning the display...25

6.1.2

Cleaning the Control Panel...26

6.1.3

Cleaning the Cover...26

6.1.4

Cleaning other Parts...26

Disinfection...26 6.2.1

Identifying the Parts to Disinfect...27

6.2.2

Compatible disinfectants...30

6.2.3

Disinfection procedure...31

Cleaning Other Accessories... 33 7.1

Cleaning the Holders...33

7.2

Cleaning the ECG Cables...33

7.3

Cleaning the Peripherals...33

Appendix A Compatible Cleaners and Disinfectants... 35 A.1

Cleaners...35

A.2

Disinfectants...38 A.2.1

Wipes...38

A.2.2

Sprays...42

A.2.3

Solutions...44

A.2.4

Devices...47

A.2.5

Powders...48

Appendix B Composition... 49

B.1

Active Ingredients of the Cleaner...49

B.2

Active Ingredients of the Disinfectant...49

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

Important Information Thank you for your expression of confidence in the Mindray brand name. Mindray is constantly working on the further development of all products. Please appreciate that changes to the scope of supply in form, equipment and technology are possible for this reason. Therefore, no claims may be deduced from the information, figures and descriptions in this guide. This guide contains warnings regarding foreseeable potential dangers, but you shall always be alert to dangers other than those indicated as well. Mindray shall not be liable for damage or loss that results from negligence or from ignoring the precautions and operating instructions described in this guide. If the administrator for this system is changed, be sure to hand over this guide to the new manager.

WARNING The probe and accessories supplied with it are not delivered disinfected or sterilized. Cleaning and disinfection (or sterilization) in accordance with this guide before use are required. After disinfection or sterilization, residual chemicals must be completely removed. Otherwise, personal injury or damage to the probes or accessories may occur.

About this Guide Please follow the descriptions in the guide to clean and disinfect (or sterilize) the probes, needle-guided brackets, entire machine and accessories manufactured by Mindray. The guide is intended to provide information about cleaning and disinfecting (or sterilizing) the ultrasound system effectively, and also about protecting the ultrasound system from damages caused by incorrect cleaning, disinfection or sterilization procedures. Mindray has verified that the disinfectants and disinfection equipment descried in this guide are compatible with the ultrasound system. All the verified disinfectants are listed in disinfectant list of this guide. The disinfectants and sterilants described in the guide are recommended by Mindray. For details on effectiveness and clinical application of these disinfectants and sterilants, refer to the instructions of disinfectant and sterilant manufacturers. The functions and accessories described in the guide may vary with the specific system you purchased.

Meaning of Signal Words DANGER, WARNING, CAUTION, NOTE and In this guide, the signal words Tip are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this guide.

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

Signal word WARNING

Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate injury.

NOTE

Meaning

Indicates a potentially hazardous situation that, if not avoided, may result in property damage.

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

General information about cleaning, disinfection and sterilization

General information about cleaning,

1.1

Safety Precautions

disinfection and sterilization

Follow the following precautions strictly to ensure the safety of the patient and the operator.

WARNING ● Do not subject the probe to shock. A defective probe may cause electric shock to the patient.

● Do not disassemble the probe to avoid the possibility of electric shock. ● Never immerse the probe connector into liquids such as water or disinfectant, for the connector is not waterproof. Immersion may cause electric shock or malfunction.

● In normal diagnostic ultrasound mode, there is no danger of a normaltemperature burn; however, keeping the probe on the same region of the patient for a long time may cause such a burn.

CAUTION ● The probe is only for use with the specified ultrasonic diagnostic system. Please refer to the ultrasonic diagnostic system operation manual to select the proper probe.

● A probe sheath must be installed over the probe throughout intra-cavity or intraoperative examination.

● Damage to the probe may occur due to its contact with improper detergents or coupling gel. DO NOT dip the probe in the strong polar solution of ethanol, chloride of lime, ammonium chloride, acetone and formaldehyde. The probe should not make contact with solution or ultrasound gel containing oily medium such as mineral oil or lanoline.

● Coupling gel must be used during ultrasonic examination. Please use the ultrasound gel compliant with the relevant local regulations. And manage the ultrasound gel properly to ensure that it does not become a source of infection.

● Do not use the carrying case for storing the probe. If the carrying case is used for storage, it may become a source of infection.

● The probe and accessories supplied with it are not delivered disinfected or

sterilized. Cleaning and disinfection (or sterilization) in accordance with this guide before use are required.

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

General information about cleaning, disinfection and sterilization

● Disposable components are packaged sterile and can be used once only. Do not use if integrity of packaging violated or if expiration date has passed. Please use the disposable components compliant with the relevant local regulations.

● Use the disinfection or sterilization solution recommended in this guide only. Otherwise, Mindray will not be liable for damage caused by other solutions. If you have any questions, please contact Mindray Customer Service Department.

NOTE: ● Read the following precautions to prevent the probe from malfunction: ● Before connecting or disconnecting the probe, freeze the ultrasonic image or turn off the diagnostic ultrasound system.

● Clean and disinfect (or sterilize) the probe before and after each examination. ● To prevent the probe from being damaged, do not use it where it will be exposed to: –

Locations exposed to direct sunlight

–

Locations subject to sudden changes in environmental temperature

–

Dust

–

Excessive vibration

–

Locations near heat generators

● Cleaning cannot be replaced by sterilization. Probes and needle-guided brackets must be cleaned before sterilization.

● Repeated disinfection will eventually damage the probe, please check the probe performance periodically.

● Repeated disinfection will degrade the performance and safety of the needle-guided brackets.

1.2

Brief Introduction to Materials

1.2.1

Plastics Plastic is material consisting of any of a wide range of synthetic or semi-synthetic organic compounds that are malleable and so can be molded into solid objects. It is made up of additives including synthetic resin, filler, plasticizer, stabilizer and pigment. The plastic housing molded by injection molding process is anti-stamping, heat-resistant and stable in dimensions. However, some general engineering plastics (especially ABS) contain unsaturated double bonds. During the storage or application of these plastics, due to external factors such as illumination and oxidization, unsaturated double bonds will result in yellowing, degraded mechanical performance or even cracking. Plastics in reusable medical devices manufactured by Mindray can be cleaned and disinfected (or sterilized) by using the recommended methods. For all plastics cannot withstand repeated actions of alcohols, do not disinfect or sterilize the plastic material in a way that is not recommended. Plastic is mainly used in probe housings.

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

General information about cleaning, disinfection and sterilization

1.2.2

Stainless Steel Stainless steel is corrosion resistant due to a natural passive layer which forms in the air. If this passive layer is destroyed by certain substances (solid, liquid or gaseous), there is no longer any corrosion resistance. The stainless steels may also corrode, particularly if they are in contact with blood or tissue residues. Therefore make certain, not only for hygienic reasons, that organic remnants have been completely removed. Stainless steel is mainly used in needle-guided brackets.

1.2.3

Silica Gel Silica gel is excellent in thermo oxidative stability, weather resistance, and resistance to oxygen, ozone and ultraviolet radiation, for the backbone of silica gel consists of Si-O-Si bonds. However, polysiloxane has a helical structure and therefore has a good gas and vapor permeability. The long-time immersion disinfection or sterilization may result in the inflation of polysiloxane. And the solution may permeate silica gel to damage the parts protected by silica gel. Therefore, disinfection should be performed in accordance with the immersion time specified by the disinfectant manufacturer. Nevertheless, silica gel attracts dirt. Thus, make sure that organic residues are removed completely after cleaning and disinfection (or sterilization). Silica gel is mainly used in sealant of acoustic lens and housing of probe.

1.2.4

Epoxy Glue Epoxy glue, as one kind of thermosetting resins, has a good bonding effect on various interfaces, even in a high temperature of 110°C. It has resistance to ultraviolet radiation, erosion and weather. The long-term immersion in peroxymonosulfuric acid, hydrogen peroxide, hypochlorite or glutaraldehyde may discolor epoxy glue slightly, but will not affect its performance. Epoxy glue is mainly used in sealing of the probe housing.

1.2.5

Glass Glass is mainly made up of various inorganic mineral substances, such as Zircon sand, borax and sodium carbonate. It also contains a little auxiliary materials. Its main ingredients are SiO2 and other oxide. It has resistance to erosion. Long-time immersion in disinfectant or sterilant solution will not affect its chemical properties. Glass is mainly used in monitor and touch screen of the ultrasound system.

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

This page intentionally left blank.

Inspection Before and After Use

Inspection Before and After Use Brand new equipment should be unpacked and checked after delivery. If there is any transport damage, contact Mindray Customer Service Department immediately. Every probe passes through an extensive cleaning and final check at the end of the manufacturing process. However, soiling is possible during transportation and storage. Therefore the probes must go through the complete cleaning and disinfection procedure before their first use. Inspection before and after use must be performed as described below to ensure safe operation of the probe. If any abnormality is found, immediately stop using the probe and contact Mindray Customer Service Department or sales representative.

2.1

Appearance Inspection Before and after each examination, confirm that there are no abnormalities of the probe surface or cable sheath, such as peeling, cracks, protruding parts, or looseness of the acoustic lens.

WARNING Probe abnormalities may cause electric shock or injury to the patient. If any abnormality is found, immediately stop using the probe and contact Mindray Customer Service Department.

2.2

Performance Inspection After turning ON the power switch of the ultrasonic diagnostic system, perform the following checks.

2.3

The acoustic lens of the probe must not generate abnormal heat while being used. The probe temperature should be checked by hand.

The image must be normal after the system is turned on.

Use of Probe Sheath A probe sheath must be installed over the probe during examination. Probe sheaths are available for use with all clinical situations where infection is a concern. A sterile probe sheath is suggested to be used during intra-cavity examination or intraoperative examination. Use a commercially available probe sheath. To order probe sheath, contact: CIVCO Medical Instruments Co. 102 First Street South, Kalona, IA 52247-9589 USA

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

Inspection Before and After Use

Tel: 1-319-656-4447 E-mail: [email protected] http://www.civco.com

CAUTION ● A probe sheath should be used once only to prevent infection. ● Use intact probe sheaths only. ● The probe sheath contains natural rubber latex and talc that can cause allergic reactions to some individuals.

● Use probe sheaths before the expiry date. Check if the probe sheath to be used is within the expiry period.

● Do not use pre-lubricated condoms as a sheath. Lubricant may not be compatible with the probe material and damage may result.

2.4

Wearing the Probe Sheath The method of using a probe sheath is shown as follows (for reference only):

Apply an appropriate amount of coupling gel inside the sheath or on probe surface. Poor imaging may occur if no gel is applied.

Use proper sterile technique to insert the probe into a probe sheath. Pull probe sheath tightly over probe surface to remove wrinkles and air bubbles, and take care to avoid puncturing cover.

Secure the sheath with enclosed elastic bands.

Inspect the sheath to ensure there are no holes or tears. Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

Cleaning, Disinfection and Sterilization for Non-TEE Probes

Cleaning, Disinfection and Sterilization for Non-TEE Probes Before and after completing each examination, clean and disinfect (or sterilize) the probes as required. When biopsy procedures have been performed, be sure to sterilize the needleguided bracket. Fail to do so may result in the probe and the needle-guided bracket to becoming sources of infection. Please follow the instructions in the manual for cleaning.

WARNING Never immerse the probe connector into liquids such as water or disinfectant, for the connector is not waterproof. Immersion may cause electric shock or malfunction.

CAUTION ● No cleaning and disinfecting may result in the probe becoming a source of infection.

● Please follow the disinfectant manufacturer’s manual for performing cleaning and disinfection, including preparing sterile water and cleaning and disinfection time.

NOTE: ● After the examination, wipe off the ultrasound gel thoroughly. Otherwise, the ultrasound gel may solidify and degrade the image quality of the probe.

● DO NOT make the probe to become overheated (more than 55 °C) during cleaning and disinfections. High temperature may cause the probe to become deformed or damaged.

● Observe the graph here carefully to immerse the probe. Only soak parts of the probe below the strain relief.

● Repeated disinfection will eventually damage the probe, please check the probe performance periodically.

● For details about probe types, refer to section Probes and Needle-guided Brackets Available in the operator’s manuals of the ultrasound system.

● For details about recommended disinfectants for probes, see “Appendix A Compatible Cleaners and Disinfectants”.

3.1

Cleaning and Disinfection/Sterilization Overview Cleaning and disinfection refer to two distinct processes. According to the Centers for Disease Control and Prevention (CDC) “Guideline for Disinfection and Sterilization in Healthcare Facilities” (2008):

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

Cleaning, Disinfection and Sterilization for Non-TEE Probes

•

Cleaning is the removal of visible soil (e.g. organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. Thorough cleaning is essential before high-level disinfection and sterilization because inorganic and organic material that remains on the surfaces of instruments interfere with the effectiveness of these processes.

•

Disinfection describes a process that eliminates many or all pathogenic microorganisms, except bacterial spores.

•

3.2

–

Low-Level Disinfection: Destruction of most bacteria, some viruses, and some fungi. Low-level disinfection will not necessarily inactivate Mycobacterium tuberculosis or bacterial spores.

–

High-Level Disinfection (HLD): Destruction/removal of all microorganisms except bacterial spores.

Sterilization describes a process that destroys or eliminates all forms of microbial life and is carried out in healthcare facilities by physical or chemical methods.

Selecting a Microbicidal Method Probes can be divided into three categories based on their intended use. Some probes may fall into more than one category (e.g. probes use for biopsy procedures). When selecting a disinfectant, determine the required level of disinfection based on intended use and possibility of cross-contamination.

3.3

•

Contacts intact skin: Probes that only come into contact with clean, intact skin are considered noncritical devices and require cleaning after every use. Cleaning may be followed by a low-level disinfectant spray or wipe.

•

Contacts mucous membranes and non-intact skin: This category includes all endocavity probes - intravaginal, transrectal, and transesophageal (TEE) and probes use for biopsy procedures. These semi-critical probes must be cleaned with an appropriate cleaner after use followed by high-level disinfection.

•

Contacts otherwise sterile tissue or body-space: These probes are considered critical and include all intraoperative probes. These probes must be cleaned with an appropriate cleaner after each use, followed by a sterilization process.

Cleaning Please refer to the instructions in the manual and follow your hospital policy and procedures for cleaning. Perform the following procedure:

Wear a pair of gloves to prevent infection.

Disconnect the probe from the system. If the sheath is used, take off the sheath and discard it.

Wipe off the ultrasound gel or other visible dirt on the surface of the probe by using a damp piece of disposable lint-free soft cloth or tissue.

Choose an appropriate cleaning agent including mild detergents, enzymatic cleaners and specially designed enzymatic sponges.

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

Cleaning, Disinfection and Sterilization for Non-TEE Probes

Immerse the probe fully in the cleaning fluid for at least 1 minute or according to manufacturer’s instructions. Lightly mechanical clean the probe with a piece of lint-free soft cloth or soft sponge until no dirt is visible. When necessary, clean the seams or biopsy guide features by using disposable cotton swabs. Avoid using a brush to wash the lens because it may damage the probe.

Rinse the probe thoroughly by using a large amount of clean water (about 7.5 L/2 gallons) at room temperature for about 30 s to remove the residual dirt and cleaning solvent. Repeat the rinsing operation twice.

Dry the probe by wiping with a piece of disposable lint-free soft cloth or tissue. Do not dry the probe by heating.

Inspect the probe. If visible dirt still exists, repeat the preceding steps to wash the probe until it is all clean.

Check whether the probe has defects such as peeling, rifts, bumps, cracks, or liquid spill. If such defects exist, the probe has reached the end of its service life. In this case, stop using it and contact the Mindray service department.

3.4

Disinfection

3.4.1

Low-level disinfection of a non-critical probe WARNING Use protective eyewear when disinfecting the probe using sprays. Perform the following procedure: 1.

Wear a pair of gloves to prevent infection.

Clean the probe thoroughly in accordance with the cleaning procedure before disinfection.

Disinfect the probe by using an appropriate low-level disinfectant. Follow the disinfection agent manufacturer’s instructions for preparation and use of the disinfectant. –

Wipes: Wipe all the surface of the probe according to the wiping duration specified in the operator’s manual provided by the manufacturer.

–

Spray: Spray the disinfectant directly on the surface of the probe or spray the disinfectant on a piece of disposable lint-free soft cloth and wipe the probe according to the wiping duration in the operator’s manual provided by the manufacturer.

Observe the graph here carefully to perform disinfection. Do not spray the strain relief on the connector end or the connector.

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

Cleaning, Disinfection and Sterilization for Non-TEE Probes Connector Strain relief

Area to be disinfected

3.4.2

Wipe away the residual disinfectant on the probe by using a piece of lint-free soft cloth soaked with clean water. Wipe three times. Or rinse the probe thoroughly by using a large amount of clean water (about 7.5 L/2 gallons) at room temperature.

Dry the probe by wiping with a piece of disposable lint-free soft cloth. Do not dry the probe by heating.

Store the probe in a cool, clean and dry environment. And repeat the cleaning and disinfection process before the next use.

High-level disinfection of a semi-critical probe Perform the following procedure: 1.

Wear a pair of gloves to prevent infection.

Clean the probe thoroughly in accordance with the cleaning procedure before disinfection.

Disinfect the probe by using an appropriate high-level disinfectant or system. For how to use a high-level disinfectant or system, see the operator’s manual provided by the manufacturer. Prepare a disinfectant by using sterile distilled or softened water when necessary. –

Soaking: Immerse the probe head in the disinfectant and shake the probe appropriately to remove any bubbles on the probe surface. For details about the probe immersion duration, see the operator’s manual provided by the manufacturer. Observe the graph here carefully to immerse the probe. Only soak parts of the probe below the strain relief.

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

Cleaning, Disinfection and Sterilization for Non-TEE Probes

Strain relief Probe handle Liquid level

–

3.5

Approx.10 mm

Wiping: Use a market disinfection wipe product or sterile disposable lint-free soft cloth wetted with disinfection spray and wipe all surfaces of the probe for a duration according to the manufacturer instructions.

Rinse the probe thoroughly by using a large amount of clean water (about 7.5 L/2 gallons) at room temperature for about 30 s to remove the residual disinfectant. Repeat the operation twice. Or follow the disinfectant manufacturer’s instructions regarding rinsing.

Dry the probe by wiping with a piece of clean disposable lint-free soft cloth. Do not dry the probe by heating.

Store the probe in a cool, clean and dry environment. And repeat the cleaning and disinfection process before the next use.

Sterilization of a critical probe CAUTION Repeated sterilization will eventually damage the probe, please check the probe’s performance periodically. For intra-operative probes, they have to be thoroughly cleaned and sterilized after completing each examination. Perform the following procedure: 1.

Wear a pair of gloves to prevent infection.

Clean the probe thoroughly in accordance with the cleaning procedure before sterilization.

Sterilize the probe by using an appropriate sterilant or system. For how to use a system, see the operator’s manual provided by the manufacturer. When using a sterilant, follow the following steps: a. Prepare a sterilant by using sterile distilled or softened water when necessary. b. Immerse the probe head in the sterilant and shake the probe appropriately to remove any bubbles on the probe surface.

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

Cleaning, Disinfection and Sterilization for Non-TEE Probes

For details about the probe immersion duration, see the operator’s manual provided by the manufacturer.

Liquid level

Immersion Sterilization (7LT4s as example)

c. Rinse the probe thoroughly by using a large amount of sterile distilled or softened water (about 7.5 L/2 gallons) at room temperature for about 30s to remove the residual disinfectant. Repeat the operation twice. Or follow the sterilant manufacturer’s instructions regarding rinsing. d. Dry the probe by wiping with a piece of sterile disposable lint-free soft cloth. Do not dry the probe by heating.

Store the probe in a cool, clean and dry environment. And repeat the cleaning and disinfection process before the next use.

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

Cleaning and Disinfection of TEE Probe

Cleaning and Disinfection of TEE Probe This section describes the methods and precautions for cleaning and disinfection of TEE probes.

WARNING ● Keep the control handle and system connector out of any cleaning or disinfection

solutions. The control handle and cable may be cleaned with a damp cloth, but only the distal end of the transducer up to the 100 cm marker on the shaft (70 cm for P8-3Ts) may be placed into a disinfection solution.

● Do not use other disinfection methods like Iodine, Steam, Heat or Ethylene Oxide. ● To a v o i d i n j u r y t o t h e p a t i e n t , y o u m u s t f o l l o w t h e m a n u f a c t u r e r ’s recommendation for rinsing.

CAUTION ● To avoid damaging the transducer, the transducer should not be exposed to the

disinfectant longer than specified to achieve the desired effect, but never longer than one hour.

● To avoid damaging the transducer, do not steam autoclave or subject the transducer to Ethylene Oxide (ETO).

● To avoid damaging the transducer, do not immerse the transducer in a solution containing ethanol.

● After disinfection, rinse the transducer thoroughly with clean water to remove all

chemical residues. Chemical residues on the transducer may be harmful to the human body.

● The efficacy of disinfectants solutions is not guaranteed by MINDRAY. Contact the manufacturers for information on the activity of the products.

NOTE: ● After the examination, wipe off the ultrasound gel thoroughly, otherwise, the ultrasound gel may solidify and degrade the image quality of the transducer.

● Do not permit the transducer to become overheated (more than 55°C) during cleaning and disinfections. High temperature may cause the transducer to become deformed or damaged.

Cleaning, Disinfection & Sterilization Guidelines for Ultrasound System

Previous Page Next Page