Canon
Biopsy, Adaptor, Water Bag, Coupler and Magnetic Securing Adapter Ultrasound Transducers Cleaning, Disinfection, and Sterilization Guidelines
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Guidelines for cleaning, disinfection, and sterilization of the biopsy adaptor, water bag, coupler, and magnetic sensor securing adaptor This manual describes the procedures for cleaning, disinfecting, and sterilizing the biopsy adaptor, water bag, coupler, and magnetic sensor securing adaptor used with the ultrasound transducers for Canon Medical Systems diagnostic ultrasound systems. For the precautions and detailed information concerning use of the biopsy adaptor, water bag, coupler, and magnetic sensor securing adaptor, refer to the corresponding operation manuals.
Trademarks This manual may include trademarks or registered trademarks of companies other than Canon Medical Systems. 2B702-069EN*F
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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.
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Observe the following precautions to ensure the safety of patients as well as operators when performing cleaning, disinfection, or sterilization of the biopsy adaptor, water bag, coupler, or magnetic sensor securing adaptor.
WARNING Clean and sterilize the biopsy adaptor
before and after each biopsy procedure. Note that local regulations may require that the biopsy adaptor be disinfected before sterilization. If the biopsy adaptor has not been properly sterilized, the biopsy adaptor may become a source of infection.
CAUTION
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 water bag and coupler and then disinfect or sterilize them before and after each examination. * Refer to the FDA's March 29, 1991 Medical Alert on Latex Products.
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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
1.2 Safety Precautions
CAUTION
2) After chemical cleaning, rinse the biopsy adaptor, water bag, coupler, and magnetic sensor securing adaptor thoroughly with purified water. After chemical disinfection, rinse these items thoroughly with sterile water or deionized water. Chemical residues may be harmful to the human body. 3) After chemical cleaning or chemical disinfection, thoroughly dry the surfaces of the biopsy adaptor, water bag, coupler, and magnetic sensor securing adaptor. 4) After gas sterilization, perform aeration to degas the biopsy adaptor, water bag, and coupler. Gas residues on these items 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.
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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 biopsy adaptor, water bag, or coupler 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 item may not be properly cleaned, disinfected, or sterilized or may be damaged. 8) 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 in section 3.
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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
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: 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.
1.4 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.
2. Cleaning, Disinfection, Sterilization This section describes the methods for cleaning, disinfection, and sterilization.
2.1 Cleaning <<Items to be used: Protective gloves, cleaning solution, purified water, clean soft cloth or gauze, single-use sponge*, soft singleuse brush>> * 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. 6
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(3) Wash off all organic materials (such as blood or other bodily fluids) from the biopsy adaptor, water bag, coupler, and magnetic sensor securing adaptor with purified water. A single-use sponge can be used to wash the water bag. The water bag is made of a very thin membrane. Do not apply excessive force to the water bag during washing. For the biopsy adaptor and coupler, a single-use sponge or soft single-use brush can be used. Do not use a hard brush because it may damage the biopsy adaptor or coupler. Use a soft single-use brush to wash the inside of the needle guide of the biopsy adaptor. Use a new sponge or brush each time washing is performed. If a sponge or brush is reused, it may become a source of infection. (4) In accordance with the tables in section 3, immerse the biopsy adaptor, water bag, coupler, or magnetic sensor securing adaptor in a cleaning solution to dissolve or remove all remaining organic materials. Use a single-use sponge or soft single-use brush if necessary. The cleaning solution must reach the inside of the needle guide. If dried organic materials are present on an item, immerse it in the cleaning solution for a prolonged period. (5) Remove all residual organic materials and chemical from the biopsy adaptor, water bag, coupler, or magnetic sensor securing adaptor by rinsing with purified water.
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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) Confirm that all parts are disassembled. Disassemble all parts that are not yet disassembled. For further information on parts that can be disassembled, refer to the operation manuals for the biopsy adaptor, water bag, coupler, and magnetic sensor securing adaptor.
(6) Dry the surface of the biopsy adaptor, water bag, coupler, or magnetic sensor securing adaptor with clean soft cloth or gauze or an air blower. Be sure to dry the inside of the needle guide. Do not use heat for drying. Confirm that all organic materials and chemical have been completely removed. (7) For the detailed handling procedures for a chemical, refer to the documentation provided by the manufacturer of the chemical. In order to maintain the effectiveness of the chemical, be sure to observe the specified concentration, replacement interval, working temperature, and other requirements. Determine the effectiveness of the chemical based on the criteria (effective period, number of times of use, discoloration of the chemical, results of testing using effectiveness test kits, etc.) described in the documentation provided by the manufacturer of the chemical. (8) Confirm that the biopsy adaptor, coupler, and magnetic sensor securing adaptor are free of damage, deformation, or peeling and that they are functioning normally. Confirm that the water bag is free of damage, deformation, or peeling.
2.2 Disinfection Before disinfection, the biopsy adaptor, water bag, coupler, and magnetic sensor securing adaptor must be cleaned. Note that local regulations may require that the biopsy adaptor, water bag, and coupler be disinfected before sterilization. <<Items to be used: Sterile protective gloves, disinfectant, sterile water or deionized water, sterile soft cloth or gauze, soft single-use brush>>
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(2) Disinfect the biopsy adaptor, water bag, coupler, and magnetic sensor securing adaptor using the chemicals listed in section 3 “List of Chemicals”. The disinfectants must reach the inside of the needle guide. Use a soft single-use brush if necessary. (a) After performing disinfection, remove all residual chemical from the biopsy adaptor, water bag, coupler, and magnetic sensor securing adaptor with sterile or deionized water. Do not reuse the sterile or deionized water. (b) Dry the surfaces of the biopsy adaptor, water bag, coupler, and magnetic sensor securing adaptor with sterile soft cloth or gauze or an air blower. Be sure to dry the inside of the needle guide. Do not use heat for drying. Confirm that all organic materials and chemical have been completely removed. For the detailed handling procedures for a chemical, refer to the documentation provided by the manufacturer of the chemical. (3) 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.
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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
(1) Wear sterile protective gloves to prevent infection. Wear new sterile protective gloves each time disinfection is performed.
(4) Confirm that the biopsy adaptor, coupler, and magnetic sensor securing adaptor are free of damage, deformation, or peeling and that they are functioning normally. Confirm that the water bag is free of damage, deformation, or peeling.
2.3 Sterilization Before sterilization, the biopsy adaptor, water bag, and coupler must be cleaned. Note that local regulations may require that the biopsy adaptor, water bag, and coupler be disinfected before sterilization. <<Items to be used: Sterile protective gloves, sterilant>> * Some types of biopsy adaptor, water bag, or coupler 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) Drain the water from the water bag before sterilizing the water bag. (3) Sterilize the biopsy adaptor, water bag, or coupler using the chemicals listed in section 3 “List of Chemicals”. * Place the biopsy adaptor, water bag, or coupler in a sterilization packing case, and then place it in the sterilizer. (4) In the case of high-pressure steam sterilization, heat the steam by performing prevacuuming three times and then start sterilization (sterilization temperature: 134°C (273.2°F), holding time: 18 minutes). Dry the items after sterilization.
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(6) Confirm that the biopsy adaptor and coupler are free of damage, deformation, or peeling and that they are functioning normally. Confirm that the water bag is free of damage, deformation, or peeling.
3. List of Chemicals This section lists the chemicals used when cleaning, disinfecting, or sterilizing the biopsy adaptor, water bag, coupler, and magnetic sensor securing adaptor. Refer to the lists for the available chemicals. In addition, refer to the manuals for the chemicals for the handling details. NOTE
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For the transducers that support each item, refer to the operation manual supplied with the corresponding item.
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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
(5) After gas sterilization, perform aeration to remove all gas residues on the sterilized items. (Aeration is not required after hydrogen peroxide plasma sterilization.)
Cleaning Country of origin : Any: Any country FRA: France DEU: Germany GBR: United Kingdom USA: United States JPN: Japan AUS: Australia
Chemical name/type Trade name Manufacturer Country of origin Concentration (Dilution ratio) Time Temperature Humidity Pressure
Model name *1 Water bag/ UAWB-021A coupler UAWB-022A UAGL-001AHA UAGV-024A UAGL-002AHA UAGV-027A UAGL004A UAGV-028A UAGL-004AHA UAGV-029A UAGV-030A UAGV020A UAGV-034A Biopsy UAGV-023A UAGV-037A adaptor*2 UAGV-035A UAGV-036A UAGV-031A UAGL-015A UAGV-032A UAGV-033A UAFS-001A UAFS-002A Magnetic UAFS-003A UAFS-004A sensor UAFS-005A UAFS-006A securing UAFS-007A UAFS-008A adaptor UAFS-009A UAFS-010A UAFS-011A UIFR-A500
OK : Use of the chemical is permitted.
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Enzyme 3M™ Rapid ® Multi-Enzyme CIDEZYME cleaner J&J
3M Company
Any Any 0.8% 1% (125) (100) 1 min. 10 min. Room temperature Normal humidity Normal pressure OK
OK
OK OK
OK
– : Use of the chemical is not permitted.
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Tristel InstruPre-Clean MetriZyme® Klenzyme® Zyme® Wipes *3 Gel DR. WEIGERT Tristel Laboratories Metrex STERIS Summit GmbH & Solutions ANIOS Research, Inc. Corporation Medical Co. KG Limited FRA DEU GBR USA USA USA 0.5% 1% Working 0.77% 0.8% Working (200) (100) solutions (130) (125) solution 5 min. 10 min. Wiping only 5 min. 5 min. Wiping only Room temperature Room temperature Room temperature Normal humidity Normal humidity Normal humidity Normal pressure Normal pressure Normal pressure ANIOSYME DD1 *3
neodisher® mediclean *3
OK
OK
OK
OK
OK
OK
–
OK
OK
–
OK
–
OK
OK
–
OK
–
OK
–
–
OK
–
–
–
–
*1: Note that some of the listed models may not be available in some regions. For the transducers that support each item, refer to the operation manual supplied with the corresponding item. *2: Sterilize the biopsy adaptor before and after use. *3: Not for use in the USA.
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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
Low/Middle-Level Disinfection -1 (Except for USA) * Note that local regulations may require that the biopsy adaptor, water bag, and coupler 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 Trade name Manufacturer Country of origin Concentration (Dilution ratio) Time Temperature Humidity Pressure
Model name *1 Water bag/ UAWB-021A coupler UAWB-022A UAGL-001AHA UAGV-024A UAGL-002AHA UAGV-027A UAGL004A UAGV-028A UAGL-004AHA UAGV-029A UAGV-030A UAGV020A UAGV-034A Biopsy UAGV-023A *2 UAGV-037A adaptor UAGV-035A UAGV-036A UAGV-031A UAGL-015A UAGV-032A UAGV-033A UAFS-001A UAFS-002A Magnetic UAFS-003A UAFS-004A sensor UAFS-005A UAFS-006A securing UAFS-007A UAFS-008A adaptor UAFS-009A UAFS-010A UAFS-011A UIFR-A500
OK : Use of the chemical is permitted.
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Didecyl dimethyl ammonium chlorides/ Quaternary ammonium compounds CLEANISEPT® WIPES Dr. Schumacher GmbH DEU Working solution Wiping only Room temperature Normal humidity Normal pressure OK
–
– –
–
– : Use of the chemical is not permitted.
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. Isopropyl alcohol/ Didecyl dimethyl ammonium chlorides
Glyoxal/Glutaral/ Didecyl dimethyl ammonium chlorides
WIP'ANIOS
Lysoformin® 3000
Laboratories ANIOS FRA Wiping only Room temperature Normal humidity Normal pressure
Lysoform Disinfection Ltd. DEU 2% (50) 15 min. Room temperature Normal humidity Normal pressure
OK
OK
–
–
–
–
–
–
–
–
Working solution
*1: Note that some of the listed models may not be available in some regions. For the transducers that support each item, refer to the operation manual supplied with the corresponding item. *2: Sterilize the biopsy adaptor before and after use.
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Low/Middle-Level Disinfection -2 (High-level disinfection is also required in the USA.) * Note that local regulations may require that the biopsy adaptor, water bag, and coupler 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 Trade name Manufacturer Country of origin Concentration (Dilution ratio) Time Temperature Humidity Pressure
Model name *1 Water bag/ UAWB-021A coupler UAWB-022A UAGL-001AHA UAGV-024A UAGL-002AHA UAGV-027A UAGL004A UAGV-028A UAGL-004AHA UAGV-029A UAGV-030A UAGV020A UAGV-034A Biopsy *2 UAGV-023A UAGV-037A adaptor UAGV-035A UAGV-036A UAGV-031A UAGL-015A UAGV-032A UAGV-033A UAFS-001A UAFS-002A Magnetic UAFS-003A UAFS-004A sensor UAFS-005A UAFS-006A securing UAFS-007A UAFS-008A adaptor UAFS-009A UAFS-010A UAFS-011A UIFR-A500
OK : Use of the chemical is permitted.
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Ethanol Ethanol Any manufacturer Any 80% (original solution) Wiping only Room temperature Normal humidity Normal pressure OK
–
– –
–
– : Use of the chemical is not permitted.
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. Isopropyl alcohol Isopropyl alcohol Any manufacturer Any 70% (original solution) Wiping only Room temperature Normal humidity Normal pressure OK
–
– –
–
*1: Note that some of the listed models may not be available in some regions. For the transducers that support each item, refer to the operation manual supplied with the corresponding item. *2: Sterilize the biopsy adaptor before and after use.
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High-Level Disinfection -1 (Except for USA) * Note that local regulations may require that the biopsy adaptor, water bag, and coupler 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/ Hydrogen peroxide, Peracetic acid type
Chlorine dioxide
Tristel Fuse Tristel Sporicidal Wipes/ for Trade name PeraSafe™*3 Tristel Rinse Instruments Wipes Manufacturer DuPont Tristel Solutions Limited Country of origin Any GBR 0.012% Concentration 1.62% Working (1 sachet in 5 liters (Dilution ratio) (61.7) solution of water) Time 10 min. 5 min. Wiping only Room Temperature Room temperature temperature Normal humidity Humidity Normal humidity Normal pressure Pressure Normal pressure
Model name *1 Water bag/ coupler UAWB-021A UAWB-022A UAGL-001AHA UAGV-024A UAGL-002AHA UAGV-027A UAGL004A UAGV-028A UAGL-004AHA UAGV-029A UAGV-030A UAGV020A UAGV-034A Biopsy *2 UAGV-023A UAGV-037A adaptor UAGV-035A UAGV-036A UAGV-031A UAGL-015A UAGV-032A UAGV-033A UAFS-001A UAFS-002A Magnetic UAFS-003A UAFS-004A sensor UAFS-005A UAFS-006A securing UAFS-007A UAFS-008A adaptor UAFS-009A UAFS-010A UAFS-011A UIFR-A500
OK : Use of the chemical is permitted.
OK
OK
OK
OK
OK
–
OK
OK
–
OK
–
–
OK
OK
–
– : Use of the chemical is not permitted.
*1: Note that some of the listed models may not be available in some regions. For the transducers that support each item, refer to the operation manual supplied with the corresponding item. 18
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Succindialdehyde
Peracetic acid, Hydrogen peroxide, Acetic acid
Peracetic acid
gigasept® FF (new)
NU-CIDEX®
Schülke & Mayr GmbH DEU
J&J GBR
5% (20)
0.35% (working solution)
15 min.
5 min.
Anioxyde 1000
gigasept® PAA concentrate
Laboratories ANIOS Schülke & Mayr GmbH FRA DEU 2% 0.15% (a double-chambered (working bottle into 5 liters of solution) water) 30 min. 5 min.
Room temperature
Room temperature
Room temperature
Normal humidity Normal pressure
Normal humidity Normal pressure
Normal humidity Normal pressure
OK
OK
OK
OK
OK
–
OK
OK
OK
–
OK
OK
OK
–
OK
OK
–
–
–
OK
*2: Sterilize the biopsy adaptor before and after use. *3: PeraSafe™ may be classified as a sterilizing agent or as a high-level disinfectant depending on the local regulations.
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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
.
High-Level Disinfection -2 * Note that local regulations may require that the biopsy adaptor, water bag, and coupler 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 Trade name
CIDEX®
CIDEX PLUS® 28 day solution
Manufacturer
J&J
J&J
Country of origin Concentration (Dilution ratio) Time
2.4% (working solution) 45 min.
Any
3.4% (working solution) 20 min.
Temperature
Room temperature
Humidity
Normal humidity
Pressure
Normal pressure
Model name *1 Water bag/ UAWB-021A coupler UAWB-022A UAGL-001AHA UAGV-024A UAGL-002AHA UAGV-027A UAGL004A UAGV-028A UAGL-004AHA UAGV-029A UAGV-030A UAGV020A UAGV-034A Biopsy UAGV-023A *2 UAGV-037A adaptor UAGV-035A UAGV-036A UAGV-031A UAGL-015A UAGV-032A UAGV-033A UAFS-001A UAFS-002A Magnetic UAFS-003A UAFS-004A sensor UAFS-005A UAFS-006A securing UAFS-007A UAFS-008A adaptor UAFS-009A UAFS-010A UAFS-011A UIFR-A500
OK : Use of the chemical is permitted.
20
Glutaraldehyde
OK
–
– –
–
– : Use of the chemical is not permitted.
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