Aplio and Aplio i-series Aplio and Aplio i-series Ultrasound Transducers Cleaning, Disinfection, and Sterilization Guidelines

20 Pages

Guidelines for cleaning, disinfection, and sterilization of transducers Issued: 2020-12 This manual describes the cleaning, disinfection, and sterilization procedures for the ultrasound transducer. For the operating precautions and procedures for the transducers, refer to the operation manual for each transducer. Trademarks This manual may include trademarks or registered trademarks of companies other than Canon Medical Systems. 2B702-068EN*M 1

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Page 1

Guidelines for cleaning, disinfection, and sterilization of transducers Issued: 2020-12 This manual describes the cleaning, disinfection, and sterilization procedures for the ultrasound transducer. For the operating precautions and procedures for the transducers, refer to the operation manual for each transducer.

Trademarks This manual may include trademarks or registered trademarks of companies other than Canon Medical Systems. 2B702-068EN*M

1. Safety Precautions 1.1

Meaning of Signal Words In this manual, the signal words DANGER, WARNING, CAUTION, and 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 manual. Signal word

Meaning

DANGER

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

WARNING

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

CAUTION

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

1.2

Safety Precautions Observe the following precautions to ensure the safety of patients as well as operators when performing cleaning, disinfection, or sterilization of the transducer.

WARNING

CAUTION

Never immerse the transducer connector or any other nonwaterproof sections into liquids such as water or cleaning solution. Immersion may cause electric shock. Refer to the tables and figures in section 3 for the immersible range of each transducer model. 1. Precautions concerning cleaning, disinfection, and sterilization. 1) Observe the following precautions to prevent infection. • Wear protective gloves when performing cleaning.* • Wear sterile protective gloves when performing disinfection or sterilization.* • Wear new protective gloves each time cleaning, disinfection, and sterilization are performed. • Clean the transducer before and after examination. Disinfect or sterilize the transducer as required. • Note that local regulations may require that the transducer be disinfected before sterilization. • Sterilize the transducer and biopsy adaptor before and after an ultrasound-guided biopsy procedure is performed. Failure to do so may result in the transducer and biopsy adaptor becoming sources of infection. * Refer to the FDA's March 29, 1991 Medical Alert on Latex Products.

2B702-068EN*M

Except for Japan and China / ⽇本・中国以外向け / 日本及中国以外的国家或地区适用

CAUTION

2) After cleaning, rinse the transducer thoroughly with purified water to remove all chemical residues. After disinfection, rinse the transducer thoroughly with sterile or deionized water to remove all chemical residues. Chemical residues on the transducer may be harmful to the human body. 3) After chemical cleaning or chemical disinfection, thoroughly dry the transducer surface. 4) After gas sterilization, degas the transducer. Gas residues on the transducer may be harmful to the human body. 5) The efficacy of the cleaning solutions, disinfectants, and sterilizing gases is not guaranteed by Canon Medical Systems. Contact the manufacturers for information on the activity of the products. 6) To ensure the prevention of infection, confirm the effectiveness of each chemical for cleaning, disinfection, or sterilization based on the criteria (such as effective period, number of times of use, discoloration, and results of using the effectiveness test kit) described in the documentation provided by the relevant manufacturer. 7) Do not clean, disinfect, or sterilize the transducer using chemicals or methods other than those specified in this guide. If chemicals or methods other than those specified in this guide are used, the transducer may not be properly cleaned, disinfected, or sterilized or may be damaged. 8) Observe the following precautions to prevent transducer malfunction. • Only soft materials such as soft cloth or soft gauze should be used when removing ultrasound gel from the transducer or wiping water or disinfectant from the transducer surface after cleaning or disinfection. Use of hard or abrasive cloth or gauze may damage the transducer. • The transducer must not be immersed in a chemical solution for more than three hours. • Do not permit the transducer to become overheated (more than 60°C (140°F)) during cleaning, disinfection, and sterilization. • The cleaning, disinfection, or sterilization conditions, such as the temperature and pressure, differ depending on the product. In addition, some products cannot be subjected to disinfection or sterilization procedures. Confirm the detailed conditions by referring to the tables and figures in section 3.

2B702-068EN*M

1.3

Chemical Hazard (for USA only) Observe the following instruction in order to protect patients and operators from inflammation or poisoning by chemical substances.

WARNING:

1.4

This product can expose you to chemicals including lead and lead compounds, which are known to the State of California to cause cancer, and phthalates, which are known to the State of California to cause birth defects or other reproductive harm. For more information go to www.p65warnings.ca.gov.

Precautions Concerning Restriction of Sale or Use (for USA only) United States law restricts this device to sale or use by, or on the order of a physician.

2B702-068EN*M

This section describes the methods for cleaning, disinfection, and sterilization. Cleaning and disinfection between patients must be performed to prevent transmission of disease. All transducers must be thoroughly cleaned prior to disinfection. The level of disinfection required is based on patient contact.

2.1

Cleaning <<Items to be used: Protective gloves, cleaning solution or cleaning wipes, purified water, clean soft cloth or gauze, single-use sponge*>> * The single-use sponge must not include any abrasive parts or contain any abrasive cleanser. (1) Wear protective gloves to prevent infection. Wear new protective gloves each time cleaning is performed. (2) If an accessory that can be disassembled (e.g., biopsy adaptor) is provided, disassemble it. For details concerning such parts, refer to the operation manual for the transducer. (3) Wash off all organic materials (such as blood or other bodily fluids) from the transducer under purified water. A single-use sponge can be used for washing. Do not use a brush, because it may damage the transducer. (4) In accordance with the tables and figures in section 3, immerse the transducer in a cleaning solution or wipe the transducer using wipes to dissolve or remove all remaining organic materials. Use a single-use sponge if necessary. If dried organic materials are present on the transducer, immerse it in the cleaning solution for a prolonged period. (5) Remove all residual organic materials and cleaning solution from the transducer by rinsing it under purified water. Confirm that all organic materials and cleaning solution have been completely removed. Do not reuse the purified water. (6) Dry the surface of the transducer using clean soft cloth or gauze. Do not use heat to dry the transducer. Handle the cleaning solution or wipes as described in the documentation provided by the relevant manufacturer. To maintain the effectiveness of the cleaning solution or wipes, ensure that the concentration, temperature, and other conditions specified in the documentation provided by the manufacturer are met. To confirm the effectiveness of the cleaning solution or wipes, use the criteria (such as effective period, number of times of use, discoloration, and results of using the effectiveness test kit) described in the documentation provided by the manufacturer. (7) Confirm that the transducer shows no signs of damage, deformation, or peeling.

2B702-068EN*M

Except for Japan and China / ⽇本・中国以外向け / 日本及中国以外的国家或地区适用

2. Cleaning, Disinfection, Sterilization

2.2

Disinfection Before disinfection, the transducer must be cleaned. Note that local regulations may require that the transducer be disinfected before sterilization. <<Items to be used: Sterile protective gloves, disinfectant, sterile water or deionized water, sterile soft cloth or gauze>> (1) Wear sterile protective gloves to prevent infection. Wear new sterile protective gloves each time disinfection is performed. (2) Disinfect the transducer using the chemicals listed in section 3 “List of Chemicals”. (3) Rinse the transducer thoroughly with sterile or deionized water, as described in the documentation provided by the manufacturer, in order to remove all residual disinfectant. (Rinsing is not necessary when gas disinfection is performed using Trophon EPR or Trophon 2.) Do not reuse the sterile or deionized water. (4) Dry the surface of the transducer using sterile soft cloth or gauze. Do not use heat to dry the transducer. Handle the disinfectant as described in the documentation provided by the relevant manufacturer. To maintain the effectiveness of the disinfectant, ensure that the concentration, temperature, and other conditions specified in the documentation provided by the manufacturer are met. To confirm the effectiveness of the disinfectant, use the criteria (such as effective period, number of times of use, discoloration, and results of using the effectiveness test kit) described in the documentation provided by the manufacturer. (5) Confirm that the transducer shows no signs of damage, deformation, or peeling.

2.3

Sterilization Before sterilization, the transducer must be cleaned. Note that local regulations may require that the transducer be disinfected before sterilization. <<Items to be used: Sterile protective gloves, sterilant>> * Some types of transducers cannot be sterilized or the sterilization conditions may differ. (1) Wear sterile protective gloves to prevent infection. Wear new sterile protective gloves each time sterilization is performed. (2) Sterilize the transducer using the chemicals listed in section 3 “List of Chemicals”. * Place the transducer in a sterilization packing case and then place it in the sterilizer. (3) After gas sterilization, perform aeration to remove all gas residues on the transducer surface. (4) Confirm that the transducer shows no signs of damage, deformation, or peeling.

2B702-068EN*M

Except for Japan and China / ⽇本・中国以外向け / 日本及中国以外的国家或地区适用

3. List of Chemicals This section lists the chemicals used when cleaning, disinfecting, or sterilizing the transducer. Refer to the lists for the available chemicals. In addition, refer to the manuals for the chemicals for the handling details. NOTE

1. When multiple model names included in the List of Chemicals are referred to, note that they are abbreviated. For example, "PSU-25BT and PSU-30BT" is abbreviated as "PSU-25BT/30BT". 2. For the transducers supported by each diagnostic ultrasound system, refer to the operation manual supplied with the diagnostic ultrasound system.

● Type A (PSU-25BT etc.)

Never immerse the non-waterproof sections of the transducer into liquids such as water or cleaning solution. Immersion may cause electric shock.

2B702-068EN*M

Cleaning Chemical name/type

Country of origin :

Enzyme

Any : Any country

Trade name

CIDEZYME®

3M™ Rapid Multi-Enzyme cleaner

ANIOSYME DD1 *

Manufacturer

J&J

3M Company

Laboratories ANIOS

FRA : France DEU : Germany GBR : United Kingdom USA : United States JPN : Japan AUS : Australia CAN: Canada

Model name PSU-25BT/30BT/70BT PVU-375BT/382BT PSU-50BT PVU-712BT PVU-674MV PLU-704BT PVU-745BTV PVU-745BTF/745BTH/770ST PVL-715RS PVU-674BT/781VT/781VTE PLU-1005BT PLU-1204BT PVU-681MVL PVU-350BTP PLU-308BTP PLU-1202BT PLU-705BTF/705BTH

Any Any 0.8% 1% (125) (100) 1 min. 10 min. Room temperature Normal humidity Normal pressure

DR. WEIGERT GmbH & Co. KG FRA DEU 0.5% 1% (200) (100) 5 min. 10 min. Room temperature Normal humidity Normal pressure

Type A

Type A Type A Type A

OK OK OK

– OK OK

Type A

Type A Type A Type A Type A Type A Type A

OK OK OK OK OK OK

Country of origin Concentration (Dilution ratio) Time Temperature Humidity Pressure Immersible range Type A

OK : Use of the chemical is permitted.

neodisher® mediclean *

–

: Use of the chemical is not permitted.

*: Not for use in the USA.

2B702-068EN*M

Tristel Pre-Clean MetriZyme® Wipes * Tristel Metrex Solutions Research Limited GBR USA Working 0.77% solution (130) Wiping only 5 min. Room temperature Normal humidity Normal pressure

Alkyl dimethyl benzyl ammonium chloride/2-ethanol/ Alkyl polysaccharide/ Ethylenediamine tetraacetic acid

Klenzyme

Instru-Zyme® Gel

Endozime® Xtreme Power*

CaviWipes™

Intercept® Wipes

STERIS Corporation

Summit Medical

RUHOF Corporation

Metrex Research

MEDIVATORS Inc.

USA 0.8% (125) 5 min.

USA Working solution Wiping only Room temperature Normal humidity Normal pressure

USA 0.2% (500) 2 min.

USA

Working solution

Wiping only Room temperature Normal humidity Normal pressure

– OK OK

OK OK OK

OK OK – OK OK OK

OK OK OK OK OK OK

OK OK – OK OK OK

OK OK OK OK – –

OK OK OK OK OK OK

OK OK – OK OK OK

OK OK – OK – –

2B702-068EN*M

Except for Japan and China / ⽇本・中国以外向け / 日本及中国以外的国家或地区适用

Enzyme

Isopropyl alcohol/ Ethylene Glycol Monobutyl Ether

Low/Middle-Level Disinfection -1 (Except for USA) Note that local regulations may require that the transducer be disinfected before sterilization. Chemical name/type

Country of origin : Any : Any country FRA : France DEU : Germany GBR : United Kingdom USA : United States JPN : Japan AUS : Australia CAN: Canada

Model name PSU-25BT/30BT/70BT PVU-375BT/382BT PSU-50BT PVU-712BT PVU-674MV PLU-704BT PVU-745BTV PLU-705BTF/705BTH PVU-745BTF/745BTH PVU-770ST, PVL-715RS PVU-674BT, PLU-1005BT PVU-781VT/781VTE PLU-1204BT PVU-681MVL PVU-350BTP PLU-308BTP PLU-1202BT

Didecyl dimethyl ammonium chlorides/ Didecyl dimethyl ammonium Quaternary ammonium compounds chlorides

Trade name Manufacturer Country of origin Concentration (Dilution ratio) Time Temperature Humidity Pressure Immersible range Type A

OK : Use of the chemical is permitted.

CLEANISEPT® WIPES Dr. Schumacher GmbH DEU

WIP'ANIOS Excel Laboratories ANIOS FRA

Working solution

Wiping only Room temperature Normal humidity Normal pressure

Type A

Type A Type A

– OK

Type A

OK*

Type A Type A Type A Type A Type A Type A Type A Type A Type A

OK* – OK – OK – – OK OK

OK OK OK OK OK OK – OK OK

–

: Use of the chemical is not permitted.

*: Only if the transducer is not used internally.

2B702-068EN*M

Benzalkonium chloride/Didecyl dimethyl ammonium chloride/ Polyhexamethylene biguanide (PHMB)

Lysoformin® 3000

Clinell®Universal Wipes

Lysoform Disinfection Ltd. DEU 2% (50) 15 min. Room temperature Normal humidity Normal pressure

GAMA Healthcare Ltd. GBR Working solution Wiping only Room temperature Normal humidity Normal pressure

– OK

OK OK

–

– OK OK – OK OK OK OK

OK OK OK OK OK – – –

2B702-068EN*M

Except for Japan and China / ⽇本・中国以外向け / 日本及中国以外的国家或地区适用

Glyoxal/Glutaral/ Didecyl dimethyl ammonium chlorides

Low/Middle-Level Disinfection -2 Note that local regulations may require that the transducer be disinfected before sterilization. Country of origin : Any : Any country FRA : France DEU : Germany GBR : United Kingdom

Isopropyl alcohol/ Ethylene glycol monobutyl ether

Sodium hypochlorite

Ethanol

Isopropyl alcohol

CaviWipes™

Dispatch® Hospital Cleaner Disinfectant Towels with Bleach

Manufacturer

Any manufacturer

Metrex Research

The Clorox Company

Country of origin

Any

USA

Concentration (Dilution ratio)

80% (original solution)

70% (original solution)

Working solution

0.65% (working solution)

Wiping only Room temperature Normal humidity Normal pressure

Wiping only Room temperature

Normal humidity

Normal pressure

Immersible range Type A

Type A

Type A Type A Type A

OK OK OK

Type A

Type A Type A Type A Type A Type A Type A

OK OK OK OK OK OK

OK OK – OK OK OK

OK OK – OK OK –

Chemical name/type

Ethanol

Isopropyl alcohol

Trade name

USA : United States JPN : Japan AUS : Australia CAN: Canada

Time Temperature Humidity Model name PSU-25BT/30BT/70BT PVU-375BT/382BT PSU-50BT PVU-712BT PVU-674MV PLU-704BT PVU-745BTV PVU-745BTF/745BTH/770ST PVL-715RS PVU-674BT/781VT/781VTE PLU-1005BT PLU-1204BT PVU-681MVL PVU-350BTP PLU-308BTP PLU-1202BT PLU-705BTF/705BTH

Pressure

OK : Use of the chemical is permitted.

–

: Use of the chemical is not permitted.

2B702-068EN*M

Quaternary ammonium chlorides/ Isopropyl alcohol

Sani-Cloth® Super AF3, Sani-Cloth® ® Plus Sani-Cloth® Sani-Cloth AF Professional Parker Disposables Professional Disposables Laboratories, International, International, Inc. Inc. Inc. USA USA USA 0.25% / 0.5% / 0.232% 0.28% 14.85% 55% (working (working (working (working solution) solution) solution) solution) Wiping only Wiping only Wiping only Wiping only Room Room Room Room temperature temperature temperature temperature Normal Normal Normal Normal humidity humidity humidity humidity Normal Normal Normal Normal pressure pressure pressure pressure Protex™ Ultra Disinfectant Wipes

Hydrogen peroxide

Isopropanol/ Ethanol/ Ethylene glycol monobutyl ether (2Butoxyethanol)/ Didecyldimethyl ammonium chloride/Water

SONO Ultrasound Wipes

Oxivir 1 wipes

PREempt Wipes

CaviWipes1™

Advanced Ultrasound Solutions Inc.

Virox Diversey, Inc. Technologies Metrex Research Inc.

USA

CAN

USA

Working solution

0.5% (working solution)

Working solution

Wiping only Room temperature Normal humidity Normal pressure

Wiping only Wiping only Room Room temperature temperature Normal Normal humidity humidity Normal Normal pressure pressure

Wiping only Room temperature Normal humidity Normal pressure

OK OK OK

OK OK –

OK OK – OK OK –

OK OK – OK OK OK

OK OK – OK OK –

2B702-068EN*M

Except for Japan and China / ⽇本・中国以外向け / 日本及中国以外的国家或地区适用

Quaternary ammonium chlorides

Decyldimethyloctylammonium chloride/ Dimethyldioctylammonium chloride/ Didecyldimethylammonium chloride/ Quaternary ammonium compounds, benzyl-C12-16alkyldimethyl, chlorides

High-Level Disinfection -1 (Except for USA) Note that local regulations may require that the transducer be disinfected before sterilization. Country of origin : Any : Any country FRA : France DEU : Germany GBR : United Kingdom USA : United States JPN : Japan AUS : Australia

Chemical name/type

Hydrogen peroxide, Peracetic acid

Trade name

PeraSafe™ *1

Manufacturer

DuPont

Tristel Solutions Limited

Country of origin

Any

GBR

Concentration (Dilution ratio)

1.62% (61.7)

0.012% (1 sachet in 5 liters of water)

Working solution

Time

10 min.

5 min.

Wiping only

CAN: Canada

Temperature Room temperature Humidity Normal humidity Pressure Normal pressure Immersible range OK Type A

OK : Use of the chemical is permitted.

Chlorine dioxide Tristel Fuse for Instruments

Tristel Sporicidal Wipes/ Tristel Rinse Wipes

Tristel Duo ULT

Room temperature Normal humidity Normal pressure OK

Type A

Type A Type A Type A

OK OK OK

– OK OK

Type A

Type A Type A Type A Type A Type A Type A

OK OK OK OK OK OK

OK OK – OK OK OK

–

: Use of the chemical is not permitted.

2B702-068EN*M

Peracetic acid Anioxyde 1000

Peracetic acid, Hydrogen peroxide, Acetic acid

Orthophthalaldehyde

gigasept® PAA concentrate

gigasept® FF (new)

NU-CIDEX®

Schülke & Mayr GmbH

J&J

DEU

GBR

Laboratories ANIOS FRA

5% (20)

0.35% (working solution)

0.15% (working solution)

0.57% (Working solution)

5 min. 30 min. Room temperature Normal humidity Normal pressure

6 min. Room temperature Normal humidity Normal pressure

5 min.*4

15 min.*2 60 min.*3 Room temperature Normal humidity Normal pressure

Opal™ Whiteley Medical AUS

mikrozid® PAA wipes

Schülke & Mayr GmbH DEU 2% (a double-chambered bottle into 5 liters of water)

Working solution

Wiping only 15 min.*3 Room temperature Normal humidity Normal pressure

– OK OK

– – –

– OK OK

OK OK OK

– OK OK

– OK –

– OK OK

–

OK OK OK OK OK –

OK OK – OK OK –

– OK – OK OK –

OK OK OK OK OK OK

OK OK – OK OK OK

*1: PeraSafe™ may be classified as a sterilizing agent or as a high-level disinfectant depending on the local regulations. *2: For bacteria and fungi *3: For virucidal *4: For mycobactericidal

2B702-068EN*M

Except for Japan and China / ⽇本・中国以外向け / 日本及中国以外的国家或地区适用

Succindialdehyde

High-Level Disinfection -2 Note that local regulations may require that the transducer be disinfected before sterilization. Chemical name/type

Country of origin :

Trade name

CIDEX®

CIDEX PLUS® 28 day solution

Manufacturer

J&J

Any : Any country FRA : France DEU : Germany GBR : United Kingdom

Glutaraldehyde

USA : United States

Country of origin

JPN : Japan

Concentration (Dilution ratio)

AUS : Australia CAN: Canada

Model name PSU-25BT/30BT/70BT PVU-375BT/382BT PSU-50BT PVU-712BT PVU-674MV PLU-704BT PVU-745BTV PLU-705BTF/705BTH PVU-745BTF/745BTH/770ST PVL-715RS PVU-674BT/781VT/781VTE PLU-1005BT PLU-1204BT PVU-681MVL PVU-350BTP PLU-308BTP PLU-1202BT

Time Temperature Humidity Pressure Immersible range Type A

OK : Use of the chemical is permitted.

Any 2.4% 3.4% (working (working solution) solution) 45 min. 20 min. Room temperature Normal humidity Normal pressure

MetriCide™

MetriCide™ MetriCide™ 28 Plus 30

Metrex Research 2.6% (working solution) 45 min.

USA 2.5% 3.4% (working (working solution) solution) 90 min. 90 min. 25°C (77°F) Normal humidity Normal pressure

Type A

Type A Type A

OK OK

– OK

Type A

Type A Type A

OK OK

Type A

Type A Type A Type A Type A Type A

OK OK OK OK OK

–

: Use of the chemical is not permitted.

*: For transducers with a thin cable, use a Trophon® EPR with a serial number beginning with 24100 or higher or a transducer cable clamp "T-Clamp". Please contact your Trophon® EPR representative for further information.

2B702-068EN*M

WAVICIDE -01 Medical Chemical Corporation USA

Sporicidin

CIDEX OPA

Hydrogen peroxide

Trophon EPR

Trophon 2

SPOROX Ⅱ

Revital-Ox™ Resert® High Level Disinfectant

Contec Inc.

J&J

Nanosonics Limited

Sultan Healthcare

STERIS Corporation

USA 1.12% 2.5% (working (working solution) solution) 45 min. 20 min. Room temperature Normal humidity Normal pressure

Any

AUS

USA

7.5% (working solution)

2% (working solution)

Use the disinfectant cartridges specifically designed for the disinfection device. 12 min. There are no disinfection related parameters (temperature, Room temperature humidity, pressure, or time) Normal humidity to be set by the operator. Normal pressure 0.55% (working solution)

30 min. 8 min. Room temperature Room temperature Normal humidity Normal humidity Normal pressure Normal pressure

OK*

– OK

OK OK

OK OK*

OK OK

– OK

OK OK

OK*

–

OK OK

OK* –

OK –

OK OK

OK OK OK OK OK

OK – OK OK OK

OK OK OK OK OK

OK OK – – OK*

OK OK – – OK

OK OK – OK OK

2B702-068EN*M

Except for Japan and China / ⽇本・中国以外向け / 日本及中国以外的国家或地区适用

Orthophthalaldehyde

Glutaraldehyde

Sterilization Note that local regulations may require that the transducer be disinfected before sterilization. Country of origin : Any : Any country FRA : France DEU : Germany GBR : United Kingdom USA : United States JPN : Japan AUS : Australia CAN: Canada

Chemical name/type

Ethylene oxide gas *1

Trade name

Ethylene oxide gas

Manufacturer Country of origin Concentration (Dilution ratio)

Any manufacturer Any

Time Temperature Humidity

Model name PSU-25BT/30BT/70BT PVU-375BT/382BT PSU-50BT PVU-712BT PVU-674MV PLU-704BT

Pressure

Hydrogen peroxide plasma *2 STERRAD® 50/100S/200/NX

STERRAD® 100NX

J&J Any Use STERRAD system cassettes specifically 10% 20%*5 designed for the sterilizer. Exposure time: Exposure time: Select [SHORT Cycle] for Select [EXPRESS Cycle]. 7 hours 3.5 hours STERRAD 100S/200 *4 and There are no Aeration time: Aeration time: [STANDARD Cycle] for sterilization related 12 hours 12 hours STERRAD NX. parameters There are no sterilization 50°C (122°F) 60°C (140°F) (temperature, related parameters humidity, pressure, or (temperature, humidity, time) to be set by the 50% pressure, or time) to be operator. set by the operator. 980 hPa [gauge] –

–

OK*7, *8

–

– –

– OK

OK*7, *8

PVU-745BTV

–

OK*6

OK*7, *8

PVU-745BTF/745BTH PVL-715RS PVU-770ST PVU-674BT PLU-1005BT PLU-1204BT PVU-681MVL

– – –

OK*6 – –

OK OK OK

OK*7, *8 –

–

OK*7, *8

– – OK

– –

OK*7, *8 –

OK*6

OK – OK

PLU-308BTP*3

OK*6

OK*7, *8

PVU-781VT/781VTE

–

OK*6

OK*7, *8

PLU-1202BT

–

OK*6

OK*7, *8

–

OK*6

OK*7, *8

PVU-350BTP*3

PLU-705BTF/705BTH

OK : Use of the chemical is permitted.

–

OK*7, *8

: Use of the chemical is not permitted.

*1: After sterilization, thoroughly degas the transducer to remove all gas residues on the transducer. *2: Note that the label on the transducer may fade. This is not an abnormality. *3: The biopsy adaptors, needle stopper, and depth gauge supplied with the transducer can be also sterilized by highpressure steam sterilization (temperature: 134°C (273.2°F), holding time: 18 min). *4: For STERRAD 100S/200 for the USA, no Cycle option is provided. *5: Not for use in the USA. *6: These items have been confirmed to withstand 120 cycles of sterilization using the method described in this manual. *7: One transducer can be sterilized per sterilization cycle. Do not perform sterilization for more than one item at a time. *8: There may be sticky areas on the cable, however, this is not a fault. If there are sticky areas, wipe them with a soft cloth or gauze moistened with ethanol.

2B702-068EN*M

Except for Japan and China / ⽇本・中国以外向け / 日本及中国以外的国家或地区适用

4. Other Information ● For Europe CANON MEDICAL SYSTEMS EUROPE B.V. EC

REP

Zilverstraat 1, 2718 RP Zoetermeer, The Netherlands

https://eu.medical.canon For other countries, please contact your local distributor.

● Legal manufacturer Canon Medical Systems Corporation 1385, Shimoishigami, Otawara-shi, Tochigi 324-8550, Japan

2B702-068EN*M

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