ZONARE Transducers ZONARE. ZONARE Transducers. Cleaning & Disinfection. Cleaning & Disinfection of ZONARE Transducers Q00066 Rev N

Transcription

1 ZONARE ZONARE Transducers Cleaning & Disinfection Page 1 of 10

2 ZONARE Medical Systems Inc. 420 N. Bernardo Avenue Mountain View, CA USA MedPass International Ltd. Windsor House Bretforton, Evesham, Worcestershire, WR11 7JJ, United Kingdom United Kingdom Technical Support North America and Asia: Phone support: or Sales support: , Europe: Phone support: +49 (913) Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner (USA). Part Number Q M Cleaning & Disinfection of ZONARE Transducers October by ZONARE Medical Systems Inc. All rights reserved. Page 2 of 10

3 Symbols Refer to the ZONARE Ultrasound System Safety Manual, Operator s Manual or Instructions for Use for a description of the system including compatible transducers and operating instructions. Page 3 of 10

4 Intended Use ZONARE Transducers are intended for use with ZONARE s Ultrasound Systems. Refer to the corresponding ZONARE Ultrasound System Manual(s) for the Intended Use. Cautions and Warnings Refer to the corresponding ZONARE Ultrasound System Manual(s) or Instructions for Use for a complete list of Warnings and Cautions associated with the use of the ZONARE Transducers and Ultrasound System. CAUTIONS Disinfectants identified are recommended because of their chemical compatibility with product materials, not their biological effectiveness. For biological effectiveness of a disinfectant, see the guidelines and recommendations of the disinfectant manufacturer. During immersion disinfection, never immerse the transducers longer than 45 minutes. Damage may occur to the transducer housing and/or components if disinfection times exceed these recommended limits. Using a non-recommended cleaning or disinfectant solution, incorrect solution strength, or immersing the transducer deeper or longer than indicated can damage the transducer. Damages linked to the use of disapproved chemicals are not covered under product warranty or service contract. To prevent possible damage to the electronics of the transducer, never immerse the transducer beyond the point (10 mm below the top edge of the transducer housing) shown in Figure 1. Additionally, use caution during disinfection process to avoid getting fluid on transducer pins. Do not use any cleaner or disinfectant on the transducer pins. Nanosonics Trophon High-Level Disinfection method has been qualified for use on the E9-4 Transducer running software version L or higher on the z.one ultra Ultrasound System and all software versions on the ZS3 Ultrasound System. Running software versions prior to L on the z.one ultra after using the Trophon EPR disinfection system can result in acoustic output levels exceeding FDA limits. Note: The software version on the z.one ultra can be verified by pressing the service key. Do not use the carrying case for storing the transducer. If the carrying case is used for storage, it may become a source of infection. The transducer and accessories supplied with it are not delivered disinfected or sterilized. Sterilization (or high-level disinfect) before use is required. A legally marketed transducer sheath must be installed over the transducer before performing intra-cavitary examination. Protective barriers may be required to minimize disease transmission. Transducer sheaths are available for use with all clinical situations where infection is a concern. To order transducer sheaths, contact: CIVCO Medical Instruments Co. Tel: info@civco.com When using a transducer sheath, be sure to cover the transducer with a new (unused) transducer sheath to prevent infection during examination. If the package of a transducer sheath is open or broken, the sterilization of the transducer sheath may not be sufficient. DO NOT use such a transducer sheath. DO NOT use an expired transducer sheath. Before using transducer sheaths, verify whether the term of validity has expired. The cover contains natural rubber latex and talc that can cause allergic reactions in some individuals. Page 4 of 10

5 WARNINGS Always examine transducers for damage, such as cracks, splitting, holes, or fluid leaks. If damage is evident, discontinue use of the transducer and contact ZONARE. Prior to initiating any disinfection process, disconnect the transducer from the Ultrasound System. To avoid electrical shock prior to cleaning any device, turn off the system and unplug from AC power outlet. Do not allow disinfectant to contact metal surfaces. Always use protective eyewear and clothing when cleaning or disinfecting device. Disinfectant wipes and topical spray products are not FDA cleared high-level disinfectants and do not provide adequate protection should the transducer become cross-contaminated. General Cleaning ZONARE Transducers are not provided cleaned and/or disinfected. The user must clean and/or disinfect ZONARE transducers prior to use, as appropriate. When choosing a disinfectant, determine the required level of disinfection based on intended use and possibility of cross-contamination. Cleaning & Disinfecting Note: The instructions below should be used in conjunction with the Cleaning and/or Disinfection agent manufacturer s instruction for use. These provide guidelines to ensure ZONARE transducers are not damaged during the cleaning and/or disinfection process. Wipe Method 1. Wear sterile gloves to reduce contamination transfer and infection. 2. Disconnect the transducer from the Cart or Scan Engine/Scan Module. If present, remove the transducer cover/sheath and discard. 3. Use a soft cloth dampened with a mild soap (Liquinox) and water solution to remove particulate, ultrasound coupling gel, or body fluids. 4. Examine the transducer for damage, such as cracks, holes, or fluid leaks. If damage is evident discontinue use of the transducer and contact ZONARE Technical Support. 5. Next, ZONARE recommends the use of a disinfectant solution to wipe the transducer housing, strain relief and cable. Follow the disinfectant manufacturer's instructions for proper cleaning. A list of approved disinfecting solutions is listed below. 6. Air-dry (or towel dry) the transducer with a soft, clean cloth. Immersion Method NOTE: All transducers may be immersed except for AUX CW probes. 1. Wear sterile gloves to reduce contamination transfer and infection. 2. Disconnect the transducer from the Cart or Scan Engine/Scan Module. If present, remove the transducer cover/sheath and discard. 3. Use a soft cloth dampened with a mild soap (Liquinox) and water solution to remove particulate, ultrasound coupling gel, or body fluids. 4. Examine the transducer for damage, such as cracks, splitting, holes, or fluid leaks. If damage is evident, discontinue use of the transducer and contact ZONARE Technical Support. 5. Mix the disinfectant solution according to the manufacturer s instructions for solution strengths and disinfecting times. A list of approved disinfecting solutions is listed below. Page 5 of 10

6 6. Immerse the transducer into the disinfecting solution, ensuring it is not immersed below the depth indicated in Figure 1 (next page). Immersion time should be as recommended by the disinfectant manufacturer. 7. Wipe the surface of the transducer with a soft cloth dampened with a mild soap (Liquinox) and water solution. 8. Wipe the transducer again with a soft cloth soaked with fresh water to remove any residual cleaning solution prior to use on patients. 9. Air-dry (or towel dry) the transducer with a soft, clean cloth. Figure 1: Immersion Level Limits for Transducers High Level Disinfection 1. Wear sterile gloves to reduce contamination transfer. 2. Disconnect the transducer from the Cart or Scan Engine/Scan Module. If present, remove the transducer cover/sheath and discard. 3. Use a soft cloth dampened with a mild soap (Liquinox) and water solution to remove particulate, ultrasound coupling gel, or body fluids. 4. Examine the transducer for damage, such as cracks, holes, or fluid leaks. If damage is evident discontinue use of the transducer and contact ZONARE Technical Support. 5. Follow disinfectant manufacturer s instructions. Page 6 of 10

7 Alkazyme Anioxyde 1000 Caviwipes CIDEX CIDEX ADS CIDEX OPA CIDEX OPS CIDEX Plus CIDEX 2.2% Cideyime Dispatch EMpower Enzol Gigasept Gigasept AF Gigasept FF Gigasept PAA Hycolin Klenzyme Korsolex extra ZONARE Transducers ZONARE-Approved Transducer Disinfectant and Cleaning Agents Table 1 of 3 Type Legend: D=Disinfectant, EC=Enzymatic Cleaner, HLD=High Level Disinfectant, BLANK=Not Tested, not approved Type EC HLD D HLD HLD HLD HLD HLD HLD EC D EC EC D D D HLD D EC D A2CW Y Y A5CW Y Y C4-1 Y Y Y Y Y Y C5-2 Y Y Y Y Y Y C6-2 Y Y Y Y Y Y C8-3 3D Y Y Y Y Y Y Y Y Y Y C9-3 Y Y Y Y Y Y C9-3sp Y C9-4t Y Y Y Y Y Y C10-3 Y Y Y Y Y Y E9-3 E9-3 3D Y Y Y Y Y Y Y Y E9-4 Y Y Y Y Y Y L8-3 Y Y Y Y Y Y L10-5 Y Y Y Y Y Y L12-4v Y Y Y Y Y L14-5sp Y Y Y Y Y Y L14-5w Y Y Y Y Y Y L20-5 Y Y P4-1 Y Y Y Y Y Y P4-1c Y Y Y Y Y Y P10-4 Y Y Y Y Y Y Y P8-3TEE Y Y Y Y Y Y Y Y Y Y Y P9-3ic SINGLE USE ITEM, NOT DISINFECTIBLE Page 7 of 10

8 Metricide Metricide 14 Metricide 28 Metricide Plus 30 Metricide OPA Plus MetriZyme Omnicide 14 N.S. Omnicide 28 Oxivir Perasafe Per Diem Presept Prolystica Protex Resert XL HLD Salvanios ph7 Steranios 2% Steranios 2% N.G. Steranios 2% E.C.S. ZONARE Transducers ZONARE-Approved Transducer Disinfectant and Cleaning Agents Table 2 of 3 Type Legend: D=Disinfectant, EC=Enzymatic Cleaner, HLD=High Level Disinfectant, BLANK=Not Tested, not approved A2CW HLD HLD HLD HLD HLD EC HLD HLD D HLD D D EC D HLD D HLD HLD HLD A5CW C4-1 Y C5-2 Y C6-2 Y C8-3 3D Y Y Y Y Y C9-3 Y C9-3sp C9-4t Y C10-3 Y E9-3 Y Y Y E9-3 3D Y Y Y Y E9-4 Y Y L8-3 Y L10-5 Y L12-4v L14-5sp Y L14-5w Y L20-5 P4-1 Y P4-1c Y P10-4 Y P8-3TEE Y Y Y Y Y Y Y Y Y Y P9-3ic SINGLE USE ITEM, NOT DISINFECTIBLE Page 8 of 10

9 Sani-Cloth AF (White Top) Sani-Cloth AF3 (Gray Top) Sani-Cloth Bleach (Orange Top) Sani-Cloth HB (Green Top) Sani-Cloth Plus (Red Top) Super Sani-Cloth (Purple Top) SterBac TD-5 TD-100 Totacide 28 Trophon Virkon Wavecide-01 T-Spray T-Spray II TriAcid-N %50 IPA ZONARE Transducers ZONARE-Approved Transducer Disinfectant and Cleaning Agents Table 3 of 3 Type Legend: D=Disinfectant, EC=Enzymatic Cleaner, HLD=High Level Disinfectant, BLANK=Not Tested, not approved Type D D D D D D D HLD D HLD HLD D HLD D D D D A2CW Y Y Y Y A5CW Y Y Y Y C4-1 Y N Y Y Y C5-2 Y N Y Y Y C6-2 Y N Y Y Y C8-3 3D Y Y Y Y C9-3 Y N Y Y Y C9-3sp C9-4t Y N Y Y Y C10-3 Y N Y Y Y E9-3 Y Y Y E9-3 3D Y Y Y Y E9-4 Y N Y** Y Y Y L8-3 Y N Y Y Y L10-5 Y N Y Y Y L12-4v Y Y Y Y L14-5sp Y N Y Y Y L14-5w Y N Y Y Y L20-5 Y P4-1 Y N Y Y Y P4-1c Y N Y Y Y P10-4 Y N Y Y Y P8-3TEE Y Y Y Y Y P9-3ic SINGLE USE ITEM, NOT DISINFECTIBLE ** NOTE: Additional Information for use of Trophon High-Level Disinfection System for E9-4 Transducer (next page) Page 9 of 10

10 ** NOTE: Additional Information for use of Trophon High-Level Disinfection System for E9-4 Transducer: Nanosonics Trophon EPR System Nanosonics Trophon EPR High-Level Disinfection method has been qualified for use on the E9-4 Transducer running software version L or higher on the z.one ultra Ultrasound System and all software versions on the ZS3 Ultrasound System. Running software versions prior to L or lower on the z.one ultra after using the Trophon EPR disinfection system can result in acoustic output levels exceeding FDA limits. Note: The software version can be verified on the z.one ultra by pressing the Service Key. Page 10 of 10