Probe Instruction Manual Cleaning, Disinfection and Sterilization MN-6015 Rev 6 Aug 2017

MN1-6015 Rev. 6

ii DM# 124192 V6

MN1-6015 Rev. 6 Symbols used in this document Safety information is classified into Danger, Warning, Caution, and Note according to the level of hazards. Those terms are used in safety information provided to prevent hazards and injuries to the operator or patients.

Danger Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury to the operator or patient.

Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury to the operator or patient.

Caution Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the operator or patient, or property damage only.

Note Indicates a strong request concerning an item that must be observed in order to prevent damage or deterioration of the equipment and also to ensure that it is used efficiently. The type of safety information is indicated by the symbols below. This symbol means that attention is required. This symbol means that the described action is prohibited. This symbol means that the described action is mandatory.

iii DM# 124192 V6

MN1-6015 Rev. 6

CONTENTS

1. Applicable cleaning, disinfection and sterilization methods...1 2. Precautions for cleaning, disinfection and sterilization...3 3. Reprocessing instruction according to ISO 17664...5 4. Point of use (Pre-cleaning)...7 A). Probes...7 B). Bite block ...7

5. Containment and transportation...7 6. Manual cleaning and disinfection...9 A). Probes...9 B). Bite block ...9 6-1. Manual cleaning ...10 A). Probes...10 B). Bite block...10 6-2. Manual disinfection ... 11 A). Probes... 11 B).Bite block...11 6-3. Cable and connector...12

7. Automated cleaning and disinfecting ...13 8. Applicable cleaners and disinfectants / Suppliers List ...15 9. Drying... 17 A). Probes...17 B). Bite block...17

10. Maintenance, inspection and testing... 17 11. Packaging... 17 12. Sterilization...19 12-1. Ethylene oxide (EtO) gas sterilization...19 12-2. STERRAD® sterilization...20 12-3. Liquid sterilization (USA only)...21 12-4. Autoclave sterilization...22 12-5. STERIS® sterilization...22

13. Storage...23

This instruction manual contains 4 pages of front matter and 24 pages of the main content iv DM# 124192 V6

MN1-6015 Rev. 6

1. Applicable cleaning, disinfection and sterilization methods Applicable cleaning, disinfection and sterilization methods for each product are listed in the Table 1. The detail of each method is described in Chapter 3. Table 1 Applicable cleaning, disinfection and sterilization methods

Autoclave

STERIS®

X

X

Need waterproof case (WP-001)

*2: Liquid sterilization USA only

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X

X

X

X

X

X

X

Note: X means “Applicable” *1: Automated

Liquid *2

X

STERRAD®

B

EtO

Bite block

Sterilization

Automated *1

X

Disinfection

Manual

A

Automated *1

S3ESEL

Manual

Model

Refer the corresponded items in Chapter 4, 6, 7, 9 and 12

Cleaning

MN1-6015 Rev. 6

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MN1-6015 Rev. 6 2. Precautions for cleaning, disinfection and sterilization The following warnings and cautions must be observed when cleaning, disinfecting and sterilizing the probe and accessories.

Warning Wear protective gloves and other protective gear during cleaning, disinfection and sterilization. Handling of the probe with your bare hands before sterilization can result in an infection. After finishing soaking the probe in cleaning agents, thoroughly wash it with running water. Residual cleaning agents can cause an adverse reaction to the operator or the patient. After chemical sterilization, thoroughly wash the probe with sterile water. Residual chemicals can cause an adverse reaction to the operator or patient. (USA only) After soaking in a disinfectant, throughly wash the equipment with deionized water. Leavings of the disinfectant can cause an adverse reaction on the bodies of the operator or patient. Perform full aeration after gas sterilization. Residual gas can cause an adverse reaction to the operator or patient. Do not clean or sterilize using procedures other than those specified in this manual. Failure to clean and sterilize the equipment can result in an infection. It can also result in damage to the probe or reduced performance. The probe is not compatible with autoclave sterilization or boiling and other types of sterilization at temperatures exceeding 60°C [140°F]. For details on the usage conditions of chemicals and sterilization procedures, refer to the documentation supplied with the respective chemical or sterilization equipment. Infection can be resulted due to incomplete sterilization. Wrong sterilization procedure could cause deterioration of the probe.

Caution Do not immerse the probe into any liquid beyond the range of IPX7. The range is indicated in the separate instruction manual “Specification”. If any liquid enters the connector, immediately stop using the probe and contact one of our offices and/ or distributor’s offices listed on the back cover. Liquid in the connector could cause electric shock to the operator or patient. Do not wipe the ultrasonic radiation part with alcohol. Alcohol could damage the part. Do not use organic solvent such as thinner for cleaning to prevent the probe from damage. Do not use hard or sharp objects to remove residue on the probe. Such objects may damage the probe. If it is necessary to use a waterproof case, obey the instruction manual of waterproof case regarding fitting to the probe. Additional information: The Instructions provided above have been validated by the medical device manufacturer as being CAPABLE of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the processing as actually performed using equipment, material and personnel in the processing facility achieve the desired result. This requires validation and routine monitoring of the process. Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences. -3DM# 124192 V6

MN1-6015 Rev. 6

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MN1-6015 Rev. 6 3. Reprocessing instruction according to ISO 17664 The probe and accessory must be reprocessed after each use. Refer to the reprocessing instruction in this chapter. Table 2 WARNINGS

・The probe is delivered unsterile. Prior to the first use, reprocess the probe. ・Temperature should not exceed 60°C[140°F] during reprocessing. ・Probe connector has no water resistance.

Limitations on reprocessing

The probe is not completely submergible (Do not immerse the probe into any liquid beyond the range of IPX7. The range is indicated in the separate instruction manual “Specification”.） Parts which are not submergible can only be disinfected by wipe disinfection.

Transportation before using

The probe should be packed in a sterile pouch or container to transport from Central Sterile Supply Department (CSSD) to an operating room. Be careful not to damage the sterile pouch or container during transportation.

The level of processing required depends on the type of equipment and its use. The CDC (Centers for Disease Control and Prevention) in the USA and the RKI (Robert Koch Institute) in Germany classify medical devices according to their use. For each classification, they specify the level of disinfection/ sterilization processing that is required before use. Table 3 summarizes this information. Table 3 Classification

Definition

Processing

Noncritical

Application part only contacts intact and uninjured skin

Cleaning ↓ Disinfection [in the USA, low-level disinfection]

Application part contacts mucosa (intracavitary application)

Cleaning ↓ Disinfection (Disinfectant with bactericidal, fungicidal and virucidal effect) [in the USA, high-level disinfection or sterilization]

Semicritical

Critical

Application part contacts intracorporeal tissue directly (intraoperative application)

Cleaning ↓ Disinfection ↓ Sterilization *1

*1. When sterilization is not possible, the FDA in the USA recognize that disinfection (in the USA, high-level disinfection) and the use of a sterile gel and sterile transducer cover, as described in the instructions provided with the transducer cover, is an accepted method of infection control for probe.

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MN1-6015 Rev. 6 Flowchart of reprocessing process of this probe and accessories is as follows: Point of use (Pre-cleaning)

Containment and transportation

Washer disinfector (WD)

Manual cleaning and disinfection Manual cleaning

Rinsing after manual cleaning

Automated cleaning

Drying Automated disinfection Manual disinfection

Rinsing after manual disinfection

Drying

Maintenance, inspection and testing

Packaging

Sterilization

NOTE: Only the accessories are compatible with automated reprocessing according to the flowchart above.

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MN1-6015 Rev. 6 4. Point of use (Pre-cleaning) Pre-cleaning should be done immediately after each use. The procedure is as follows: A). Probes 1)

Clean the probe of all patient’s blood or fluid with running tap water until the surface of the probe looks visually clean.

2)

Wipe the whole surface of the probe by gauze pad and remove superficial visible impurities until the surface looks visually clean.

B). Bite block 1)

Clean the bite block of all patient’s blood or fluid with running tap water until the surface of the bite block looks visually clean.

2)

Wipe the whole surface of the bite block by gauze pad and remove superficial visible impurities until the surface looks visually clean.

5. Containment and transportation Putting the contaminated equipment into exclusive shock and damage proof container for transportation is recommended. It is recommended that instruments are reprocessed as soon as possible and not later than 4 hours after usage.

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MN1-6015 Rev. 6

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MN1-6015 Rev. 6 6. Manual cleaning and disinfection Prepare following items before manual cleaning and disinfection. A). Probes 1) Detergent: ENZOL®/Cidezyme® (Johnson & Johnson, #2258) or another cleaning agent with approved material compatibility for this medical device. 2) Disinfectant: Cidex® OPA (Johnson & Johnson, # 20391) or another disinfectant with approved material compatibility for this medical device. 3) 2 tanks, 1 for cleaning and 1 for disinfection - optional: 1 additional tank for rinsing with deionized/tap water. (sufficient size for immersion of the submergible part of the probe at full length) 4) Soft, fluff free cloth or single use towel 5) Personal protective equipment (gloves, water repellent protective skirt, face protection mask or protective glasses, see also instructions of the manufacturer for the detergent and the disinfectant) B). Bite block 1) Detergent: Cidezyme®/ENZOL® (Johnson & Johnson, # 2258) or another cleaning agent with approved material compatibility for this medical device 2) Disinfectant: Cidex® OPA (Johnson & Johnson, # 20391) or another disinfectant with approved material compatibility for this medical device 3) 2 tanks, 1 for cleaning and 1 for disinfection - optional: 1 additional tank for rinsing with deionized/tap water (sufficient size for immersion of the bite block) 4) Soft, fluff free cloth or single use towel 5) Personal protective equipment (gloves, water repellent protective skirt, face protection mask or protective glasses, see also instructions of the manufacturer for the detergent and the disinfectant)

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MN1-6015 Rev. 6 6-1. Manual cleaning A). Probes 1)

The temperature of the detergent solution should be between 15-30 °C[59-86°F], concentration is 1.6%. Please note the minimum contact time of the detergent in the manufacturer’s instruction. If a differing detergent is used, please also consider the approved material compatibility for this probe.

2)

Immerge the submergible part of the probe into the detergent.

3)

Wipe the submergible part of the probe under the surface of the detergent solution with a single-use, fluff free soft cloth to remove all visible soil. Be sure that all grooves of the probe are implemented during the cleaning process. If necessary use an appropriate cleaning brush for this purpose.

4) Wipe the non-submergible parts of the probe with a soft cloth dipped with a detergent. Particular attention is required for the cleaning of the lock lever and adjusting knob of the probe.Every column of the adjusting part should be wiped with a soft cloth dipped with detergent solution to assure that no soil is left in the cavities of the handling part. 5) Rinse the submergible part of the probe with running tap water for 1 minute. (Alternatively, immerse the submergible part of the probe in a tray filled with deionized water/ tap water for 5 min.) 6) Visually check the outer surface of the probe for cleanness. If necessary, use magnifying glass for visually check. If there is still soil visible, repeat all above steps. B). Bite block 1)

The temperature of the detergent solution should be between 15-30 °C, concentration is 1.6%. Please note the minimum contact time of the detergent in the manufacturer’s instruction. If a differing detergent is used, please also note the approved material compatibility for the medical device.

2)

Immerge the bite block into the detergent.

3)

Wipe the bite block under the surface of the detergent solution with a single-use fluff free soft cloth to remove all visible soil. Be sure that all grooves of the bite block are implemented during the cleaning process. If necessary use an appropriate cleaning brush for this purpose.

4) Rinse the bite block with running water 1 minute. (Alternatively: immerse the bite block in a tray filled with deionized/tap water for 5 minutes). 5) Visually check the outer surface of the bite block for cleanness. If necessary, use magnifying glass for visually check. If there is still soil visible, repeat all above steps.

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MN1-6015 Rev. 6 6-2. Manual disinfection A). Probes 1)

Confirm the concentration of the disinfectant before immersing the probe. Although Cidex® OPA does not need to be diluted, it is recommended to use test strips to verify the concentration. The test strips can indicate whether or not the concentration is above the Minimum Effective Concentration (MEC). Please also note the expiration date of the test stripes. Temperature of disinfectant solution should be minimum 20 °C[68°F]. The minimum contact time is 5 minutes. If a differing disinfectant is used, follow the manufacturer’s instructions. Please also consider the material compatibility for the medical device.

2)

Wipe the non-submergible parts of the probe with a soft and fluff free cloth with disinfectant. Particular attention is required for the disinfection of the lock lever and adjusting knob of the probe. Every column of the adjusting part should be wiped with a soft cloth dipped with disinfectant solution to assure that every cavity of the handling part is implemented.

3)

Immerge the submergible part of the probe into the disinfectant. Set a clock to insure the recommended contact time is observed.

4) Rinse the submergible part of the probe with running deionized water for 1 minute. (Alternatively, immerse the submergible part of the probe in a tray filled with deionized water for 5 min.) 5) Visually check the outer surface of the probe for that there are no leavings of the disinfectant. If necessary, repeat the rinsing.

Caution Do not wipe the ultrasonic radiation part with alcohol. Alcohol could damage the part. B).Bite block 1)

It is recommended to test the concentration of disinfectant solution before each usage. The solution Cidex® OPA is ready for use and does not need to be diluted. Test strips to verify that the appropriate concentration of Cidex® OPA is correct are available by manufacturer.Test strips will indicate a concentration above the Minimum Effective Concentration (MEC). Please also note the expiration date of the test stripes. Temperature of disinfectant solution should be minimum 20°C. The minimum contact time is 5 minutes. If a different disinfectant is used, follow the manufacturer’s instructions. Please also consider the material compatibility for the medical device.

2)

Immerge the bite block into the disinfectant. Set a clock to insure the recommended contact time is observed.

3)

Rinse the bite block with running deionized water for 1 minute. (Alternatively: immerse the bite block in a tray filled with deionized water for 5 minutes).

4) Visually check the outer surface of the bite block for that there are no leavings of the disinfectant. If necessary, repeat the rinsing.

Warning After finishing soaking the probe in the cleaning agent or disinfectant, thoroughly rinse it with running water (after cleaning) and deionized water (after disinfection). Residual agent can cause an adverse reaction to the operator or patient. -11DM# 124192 V6

MN1-6015 Rev. 6 6-3. Cable and connector Wipe the cable in 20 cm intervals with gauze dipped in ethyl alcohol or water, and dry it after wiping. Clean the connector with gauze dipped in ethyl alcohol, and dry it after cleaning. Clean the other parts of the probe which must not be soaked in liquid in the same manner as the connector.

Note If the entire length of the cable is wiped at once, a part of the cable may be wrinkled. If this occurs, pull the wrinkled part in the opposite direction to smooth it.

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MN1-6015 Rev. 6 7. Automated cleaning and disinfecting A). Probe

Warning The probe cannot withstand automated cleaning and disinfecting.

B). Bite block The following items must be provided prior to automated cleaning and disinfection. a)

Washer disinfector according to ISO 15883 with chemo-thermal program (temperature: max 60°C [140°F]

b)

Detergent: Korsolex® Endo-Cleaner (BODE Chemie, # 972 020) or another cleaning agent with approved material compatibility for this medical device

c)

Disinfectant: Korsolex® Endo-Disinfectant (BODE Chemie, # 972 030) or another disinfectant with approved material compatibility for this medical device

d) Washer disinfector accessories: basket with lid for holding the bite block 1)

The parameter for cleaning and disinfecting the medical device are as follows: Program step

Water (40l)

Pre-Rinse

Cold water

Cleaning

Deionized water

Rinse

Deionized water

Disinfection

Deionized water

Rinse

Deionized water

Rinse

Deionized water

Dosage (ml/l)

Temp. (°C)/(°F)

time (min) 5

5 (0.5%)

50/122

10 1

10 (1%)

55/131

5

55/131

1

55/131

15

1

Drying 2)

Place the bite block into the basket with lid.

3)

Close the door of the washer disinfector and start the chemo-thermal program.

4) Open the door after the end of the program. 5) Take the bite block out of the washer disinfector and check whether it is dry. If not, proceed as described under drying.

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MN1-6015 Rev. 6

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MN1-6015 Rev. 6 8. Applicable cleaners and disinfectants / Suppliers List The applicable chemical solutions are listed below.

General name

Trade name

Manufacturer

Enzyme cleaning agent

ENZOL®/Cidezyme® Practical liquid 0.8V/V%

ADVANCED STERILIZATION PRODUCTS® A Johnson & Johnson company Division of Ethicon, Inc.

Alkylpolyalkylenglykolether

Korsolex® Endo-Cleaner

BODE Chemie GmbH

General name

Trade name

Manufacturer

Ortho-phthalaldehyde

CIDEX® OPA Solution 0.55%

ADVANCED STERILIZATION PRODUCTS® A Johnson & Johnson company Division of Ethicon, Inc.

Dimethyl-dioctylammonium-chloride

Gigasept® AF forte *

Glutaral

Korsolex extra *

Solution 2.0%

Note: * indicates that the marked disinfectant is not applicable in Canada.

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Schülke & Mayr BODE Chemie GmbH

MN1-6015 Rev. 6

High-level disinfection General name

Trade name

Manufacturer

Hydrogen peroxide

PERASAFETM * Practical liquid 1.62W/V%

ANTEC INTERNATIONAL

Peracetic acid

Acecide® * Solution 6%

Saraya Co., Ltd

Glutaraldehyde

WAVICIDE®-01 * Solution 2.65%

Medical Chemical Corporation

Glutaraldehyde

STERANIOS * Solution 2.0%

Laboratoires ANIOS

Note: * indicates that the marked disinfectant is not applicable in Canada.

Warning After disinfection, thoroughly rinse the probe with deionized water. Residual disinfectant can cause an adverse reaction to the operator or patient.

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