37
1 QAD-Z2939 20,May.2020 2nd Ed Hitachi Healthcare Business Unit Cleaning, Disinfection and Sterilization for Ultrasound Probes and Accessories This list shows the disinfectants that can be used in Ultrasound probes and accessories. The explanation of C, N and Blank in the list is as follows. Explanation in the list is as follows. Item Definition C: Compatible C*1: Use with STERRAD® Booster (Part #15400) and STERRAD® Adapter II (Part #15402). C*2: Please refer to the instruction manual of the medical device for specific sterilization parameters. C*3: Some probe housing and its accessories will be yellowed, the surface of some plastic materials become rough and the cable sheath becomes hard and tacky by Antigermix disinfector using UVC. Hitachi, Ltd. and Germitec confirmed that the function of the probe and its accessories do not suffer damages. C*4: Optional waterproof case for probe connector is mandatory. C*5: The probe can only be cleaned/disinfected manually with this cleaner/disinfectant. C*6: Trophon Curved Probe Positioner (CPP) is required. C*7 Can be used for pre-cleaning or pre-disinfection. N: No (do not use) Blank: Not tested (do not use) CAUTION To choose an appropriate disinfectant, users must determine the required level of disinfection, based on the classification (See Table 1.) and the regulation of each country. If the probe is cleaned and disinfected by the washer disinfector system, certainly connect the waterproof case to the probe connector. The probe which cannot be connected to the waterproof case, cannot be applied to the washer disinfector system. The disinfectants listed in this list guarantee resistance to the probe. However, " cleaning / disinfecting / sterilizing effects " is not guaranteed. For " cleaning / disinfecting / sterilizing effects ", please refer to each disinfectants manufacturer's website, instruction manual, etc.

Cleaning, Disinfection and Sterilization for Ultrasound Probes and … · 2020. 5. 26. · w q u q & , & , 9(7 & . & . 9(7 & 3 & 7 & & 59 & & & 9(7 & & & 3 & & 9(7 & & % & / 53 &

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Page 1: Cleaning, Disinfection and Sterilization for Ultrasound Probes and … · 2020. 5. 26. · w q u q & , & , 9(7 & . & . 9(7 & 3 & 7 & & 59 & & & 9(7 & & & 3 & & 9(7 & & % & / 53 &

1 QAD-Z2939

20,May.2020 2nd Ed Hitachi Healthcare Business Unit

Cleaning, Disinfection and Sterilization for Ultrasound Probes and Accessories

This list shows the disinfectants that can be used in Ultrasound probes and accessories. The

explanation of C, N and Blank in the list is as follows.

Explanation in the list is as follows. Item Definition C: Compatible C*1: Use with STERRAD® Booster (Part #15400) and STERRAD® Adapter II (Part #15402). C*2: Please refer to the instruction manual of the medical device for specific sterilization

parameters. C*3: Some probe housing and its accessories will be yellowed, the surface of some plastic

materials become rough and the cable sheath becomes hard and tacky by Antigermix disinfector using UVC. Hitachi, Ltd. and Germitec confirmed that the function of the probe and its accessories do not suffer damages.

C*4: Optional waterproof case for probe connector is mandatory. C*5: The probe can only be cleaned/disinfected manually with this cleaner/disinfectant. C*6: Trophon Curved Probe Positioner (CPP) is required. C*7 Can be used for pre-cleaning or pre-disinfection. N: No (do not use) Blank: Not tested (do not use)

CAUTION

To choose an appropriate disinfectant, users must determine the required level of disinfection, based on the classification (See Table 1.) and the regulation of each country. If the probe is cleaned and disinfected by the washer disinfector system, certainly connect the waterproof case to the probe connector. The probe which cannot be connected to the waterproof case, cannot be applied to the washer disinfector system. The disinfectants listed in this list guarantee resistance to the probe. However, " cleaning / disinfecting / sterilizing effects " is not guaranteed. For " cleaning / disinfecting / sterilizing effects ", please refer to each disinfectants manufacturer's website, instruction manual, etc.

Page 2: Cleaning, Disinfection and Sterilization for Ultrasound Probes and … · 2020. 5. 26. · w q u q & , & , 9(7 & . & . 9(7 & 3 & 7 & & 59 & & & 9(7 & & & 3 & & 9(7 & & % & / 53 &

2 QAD-Z2939

Table 1 Levels of Disinfection Requirements

Classification Definition Levels of disinfection

Critical Device directly contacts tissue or blood (Intraoperative or biopsy applications) Sterilization

Semi-critical Device contacts mucous membranes (Intracavity applications) High

Non-critical Device contacts intact skin Intermediate or low

The product names, etc. described in this material are registered trademarks or trademarks of their respective companies.

Page 3: Cleaning, Disinfection and Sterilization for Ultrasound Probes and … · 2020. 5. 26. · w q u q & , & , 9(7 & . & . 9(7 & 3 & 7 & & 59 & & & 9(7 & & & 3 & & 9(7 & & % & / 53 &

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3 QAD-Z2939

Page 4: Cleaning, Disinfection and Sterilization for Ultrasound Probes and … · 2020. 5. 26. · w q u q & , & , 9(7 & . & . 9(7 & 3 & 7 & & 59 & & & 9(7 & & & 3 & & 9(7 & & % & / 53 &

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C N C CC C N C C C N C*7 C*7 C C C N N C C C C*7C C N C C C N C*7 C*7 C C C N N C C C C*7C C N C C C N C*7 C*7 C C C N N C C C C*7C C N C N C*7 N N N C C C*7C C N C C C N C*7 C*7 C C C N N C C C C*7C C N C C C N C*7 C*7 C C C N N C C C C*7C C C C C*7 C C C*3 C C C C C C*7C C C C C*7 C C C*3 C C C C C C*7C C C C C*7 C C C*3 C C C C C C*7

C C C C C C*7N N N C CN N N C C

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4 QAD-Z2939

Page 5: Cleaning, Disinfection and Sterilization for Ultrasound Probes and … · 2020. 5. 26. · w q u q & , & , 9(7 & . & . 9(7 & 3 & 7 & & 59 & & & 9(7 & & & 3 & & 9(7 & & % & / 53 &

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5 QAD-Z2939

Page 6: Cleaning, Disinfection and Sterilization for Ultrasound Probes and … · 2020. 5. 26. · w q u q & , & , 9(7 & . & . 9(7 & 3 & 7 & & 59 & & & 9(7 & & & 3 & & 9(7 & & % & / 53 &

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6 QAD-Z2939

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7 QAD-Z2939

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N C*7 C*7 C*7 C C C C*7 C*7 CN C*7 C*7 C*7 C C C C*7 C*7 CN C*7 C*7 C*7 C C C C*7 C*7 C

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C N C*7 C*7 C*7 C C C C*7 C*7 CC N C*7 C*7 C*7 C C C C*7 C*7 CC N C*7 C*7 C*7 C C C C*7 C*7 CC N C*7 C*7 C*7 C C C C*7 C*7 CC C C*7 C*7 C*7 C C C C*7 C*7 C

N C*7 C*7 C*7 C C C C*7 C*7 CC N C*7 C*7 C*7 C C C C*7 C*7 CC N C*7 C*7 C*7 C C C C*7 C*7 CC N C*7 C*7 C*7 C C C C*7 C*7 C

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C N C*7 C*7 C*7 C C C C*7 C*7 CC N C*7 C*7 C*7 C C C C*7 C*7 C

N C*7 C*7 C*7 C C C C*7 C*7 CN C*7 C*7 C*7 C C C C*7 C*7 CN C*7 C*7 C*7 C C C C*7 C*7 CN C*7 C*7 C*7 C C C C*7 C*7 CC C*7 N C*7 C C C C*7 C*7 CC C*7 N C*7 C C C C*7 C*7 CN C*7 C*7 C*7 C C C C*7 C*7 CC C*7 N C*7 C C C C*7 C*7 CC C*7 N C*7 C C C C*7 C*7 CN C*7 C*7 C*7 C C C C*7 C*7 C

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C C C*7 C*7 C*7 C C C C*7 C*7 CC C C*7 C*7 C*7 C C C C*7 C*7 CC C C*7 C*7 C*7 C C C C*7 C*7 CC C C*7 C*7 C*7 C C C C*7 C*7 CC N C*7 C*7 C*7 C C C C*7 C*7 CC N C*7 C*7 C*7 C C C C*7 C*7 C

C C*7 C*7 C*7 C C C C*7 C*7 CC N C*7 C*7 C*7 C C C C*7 C*7 CC N C*7 C*7 C*7 C C C C*7 C*7 CC N C C*7 C*7 CC N C C C*7 C C

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C*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C M02301~ C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C C*4C*7 C C M00110~ C C C C C C C C N N C*2 C NC*7 C C M00253~ C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C C M00301~ C C C C C C C C N N C*2 C C*4N N C C from first SN N N C N N N N N N N C*2 N NN N C C from first SN N N C N N N N N N N C*2 N N

C*7 C N ー C C C C N N N N N N C*2 C NC*7 C C M00104~ C C C C C C C C N N C*2 C NN N C C from first SN N N C N N N N N N N C*2 N NN N C C from first SN N N C N N N C N N N C*2 N N

ー C N N N C*2 NN N C C from first SN N N C N N N N N N N C*2 N NN N C C from first SN N N C N N N N N N N C*2 N NN N C C from first SN N N C N N N N N N N C*2 N N

C*7 C N ー C C C C N N N N N N C*2 NC*7 C N ー C C C C C C C C N N C*2 NN C N ー C C C C C C C C N N C*2 N

C*7 C N ー C C C C C C C C N N C*2 C NN C N ー C C C C C C C C N N C*2 N

C*7 C N ー C C C C C C C C N N C*2 C NN C N ー C C C C C C C C N N C*2 N

C*7 C C M00621~ C C C C C C C C N N C*2 C NN C N ー C C C C C C C C N N C*2 N

C*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NN C N ー C C C C C C C C N N C*2 N

C*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C N ー C C C C N C C C N N C*2 C NC*7 C N ー C C C C N C C C N N C*2 C NC*7 C C M00181~ C C C C C C C C N N C*2 C NC*7 C C M00451~ C C C C C C C C N N C*2 C C*4C*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C C M00884~ C C C C C C C C N N C*2 C NC*7 C C M00594~ C C C C C C C C N N C*2 C NC*7 C C M00131~ C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C C*4C*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C N C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C C*4C*7 C C C from first SN C C C C C C C C N N C*2 C C*4C*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C C*4C*7 C C C from first SN C C C C C C C C N N C*2 C C*4

C C*7 C C C C from first SN C C C C C N N C*2 C NC*7 C N ー C C C C N C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C N

C C*7 C C C C from first SN C C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C N

C C from first SN C C C C N N C N N N C*2 C NC C N ー C C C C N N N N N N C*2 C N

C*7 C N ー C C C C N C C C N N C*2 C NC*7 C N ー C C C C N C C C N N C*2 C NC*7 C N ー C C C C N C C C N N C*2 C NC*7 C N ー C C C C N C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C C*6 M00241~ C C C C C C C C N N C*2 C NC*7 C C M00104~ C C C C C C C C N N C*2 C NC*7 C C M00119~ C C C C C C C C N N C*2 C NC*7 C C M00141~ C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C C M00107~ C C C C C C C C N N C*2 C NC*7 C C*6 M00151~ C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C N C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C C*6 M01301~ C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C C*6 M01301~ C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C C M00581~ C C C C C C C C N N C*2 C C*4C*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C C C from first SN C C C C C C C C N N C*2 C NC*7 C N ー C C C C C C C C N N C*2 C NC*7 C C M00201~ C C C C C C C C N N C*2 C C*4C*7 C N ー C C C C C C C C N N C*2 C NC*7 C C M00101~ C C C C C C C C N N C*2 C C*4

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N N ー N ー ー ーC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー C Short Cycle C Standard Cycle C Standard Cycle M00131~C C C C C C M00621~ C Short Cycle C Standard Cycle C Standard Cycle M00621~N N N N N N ー C Short Cycle C Standard Cycle C Standard Cycle M00271~C C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNN N N N N N ー C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーC C C C C C M00451~ C Short Cycle C Standard Cycle C Standard Cycle M00451~N N N N N N ー N ー ー ーC C C C C C M01351~ C Short Cycle C Standard Cycle C Standard Cycle M01351~N N N N N N ー N ー ー ーC C C C C C M00884~ C Short Cycle C Standard Cycle C Standard Cycle M00884~C C C C C C M00594~ C Short Cycle C Standard Cycle C Standard Cycle M00594~C C C C C C M00131~ C Short Cycle C Standard Cycle C Standard Cycle M00131~C C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNN N N N N N ー N ー ー ーC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーC C C C C C M00241~ C Short Cycle C Standard Cycle C Standard Cycle M00241~C C C C C C M00104~ C Short Cycle C Standard Cycle C Standard Cycle M00104~C C C C C C M00119~ C Short Cycle C Standard Cycle C Standard Cycle M00119~C C C C C C M00141~ C Short Cycle C Standard Cycle C Standard Cycle M00141~N N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNN N N N N N ー N ー ー ーC C C C C C M00107~ C Short Cycle C Standard Cycle C Standard Cycle M00107~C C C C C C M00151~ C Short Cycle C Standard Cycle C Standard Cycle M00151~C C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーN N N N N N ー N ー ー ーC C C C C C M01301~ C Short Cycle C Standard Cycle C Standard Cycle M01301~N N N N N N ー N ー ー ーC C C C C C M01301~ C Short Cycle C Standard Cycle C Standard Cycle M01301~N N N N N N ー N ー ー ーN N N N N N ー N ー ー ーC C C C C C M00581~ C Short Cycle C Standard Cycle C Standard Cycle M00581~C C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNC C C C C C C from first SN C Short Cycle C Standard Cycle C Standard Cycle C from first SNN N N N N N ー N ー ー ーC C C C C C M00201~ C Short Cycle C Standard Cycle C Standard Cycle M00201~N N N N N N ー N ー ー ーC C C C C C M00101~ C Short Cycle C Standard Cycle C Standard Cycle M00101~

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MP-2781-G*MP-2781-KNO-BMP-2781-MBMP-2783-G*MP-2784-G*MP-2785-BPMP-2785-G*MP-2785-LPMP-2787MP-2794-G*MP-2824SP-7901WB-24631222371AEZU-PA31EZU-PA32EZU-PA34TEZU-PA3B4EZU-PA3C1EZU-PA3C1HEZU-PA3C2EZU-PA3C4EZU-PA3C5EZU-PA3F4EZU-PA3LEZU-PA3OEZU-PA3UEZU-PA4LEZU-PA532EZU-PA5B4EZU-PA5C1EZU-PA5C2EZU-PA5C3EZU-PA5C4EZU-PA5OEZU-PA5S0EZU-PA5S1EZU-PA6L1EZU-PA7B1EZU-PA7C1EZU-PA7C2EZU-PA7L1EZU-PA7L2EZU-PA7L3EZU-PA7LV1EZU-PA8L1EZU-TEATC1EZU-TEATC2EZU-TEBL1EZU-TEBL2EZU-TECPL1EZU-TEMC1EZU-WL1 BalloonEZU-WL1 Outer CaseEZU-WL2 BalloonEZU-WL2 Outer CaseEZU-WL3 BalloonEZU-WL3 Outer Case7225446A7230363A7231091A7231134A7231135A7231184A7331474A7349172A7349293A7349818A7349961A7436413A7436413BCA2-8AD-H/CA2-8ADCF4-9-H/CF4-9EVN4-9-H/EVN4-9LA3-16AD-H/LA3-16ADPN2-4-H/PN2-4V5-9-H/V5-9VN4-8-H/VN4-8

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37 QAD-Z2939