Mindray_Recommended Transducer Cleaner and Disinfectant Guide

[a]: Cleaners

[b]: Wipes

[c]: Sprays

b32: Super b1: CLEANISEPT® WIPES b16: CaviWipes MetriZyme b17: Dispatch Towels b2: mikrozid® AF SaniTristel Preb18: Accel TB Wipes Cloth® Wipes Jumbo Clean Wipes b33: SANIb19: CaviWipes 1 b3: PROTEXTM DISINa3: Liquinox b20: Tuffle 5 a4: Revital-OX CLOTH® FECTANT Wipes b21: Sani-Cloth Active b4: Sani-Cloth® Plus PRIME Enzymatic b22: Septiwipes b5: SONOTM ULTRAWIPES Detergent b23: Mikorbac Tissues a5: MetriSponge SOUND WIPES a6: Prolystica 2X b7: Tristel Sporicidal Wipes b24: Sani-Cloth Germicidal Wipes Concentrate b8: Tristel Rinse Wipes b9: Clinell Universal Wipes/ b25: WIP'ANIOS Enzymatic CLEAN'UP Clinell® Surface Wipes Cleaner b10: mikrozid® Senb26: CaviWipes XL a7: Endozime b27: OXIVIR™ WIPES sitive Wipes and Endozb28: Oxivir 1 Wipes ime Sponge b11: Wip’Anios premium b12: ultrasound probe b29: PDI SANI-CLOTH a8: klenzyme a9: ANIOSYME 5 cleaning wipes BLEACH WIPES b13: Sani-Cloth AF3 (gray) b30: wip anios excel a10: DDN9 b14: Protex Ultra Wipes b31: Virusolve® + Pronb15: Sani-Cloth HB te all’uso Wipes a1: a2:

Probe L10-3E/L10-3s L11-3U/L11-3VNs/L13-3N/L13-3Ns/L14-3s/ L14-3WU/L14-3WE/L14-3Ws/L14-3W L11-4/L11-4s/L14-6/L14-6s/L14-6P/10L24EA L16-4HE/L16-4Hs/L16-4HU

[a]: Cleaners a1 a1, a2, a3, a4, a5, a6, a7, a9, a10 a1, a2, a3, a4, a5, a6, a7, a9, a10 a8

OxivirTM/MC Tb PI-SPRAY II Surfa’safe TRANSEPTIC PROTEXTM DISINFECTANT SPRAY c7: Tristel Duo c8: IODOCLEAN c9: Protex Spray c10: CaviCide c11: T-Spray c12: Indican Form c13: Transeptic Spray c14: CAVICIDE 1 c15: OXIVIR 1 c16: WIP'ANIOS SPOR'ACTIV c17: Accel TB Liquid c1: c2: c3: c4: c5:

[d]: Solutions

c18: Sani-HyPerCide GERMICIDAL SPRAY c19: Sani-24 GERMICIDAL SPRAY

[b]: Wipes

[e]: Devices

e1: d27: Minncare d12: Cavicide d1: CIDEX OPA d2: Cidex Activated Diliquid Liquid disinfectant aldehyde Solution d13: Metricide d28: Virusolve® d14: Metricide 28 d3: Minncare® Cold d15: Metricide + ConSterilant e2: d4: Ster-Bac centrate OPA Plus d29: Virex II 256 d16: Cidex Plus d5: Triacid-N e3: d17: Gigasept AF d6: Revital-Ox® d18: Osvan Resert® High Level Disinfectant/ d19: Neojodin UltrOx™ High-Lev- d20: Milton d21: hibitane el disinfectant d22: Sterihyde d7: Gigasept® PAA d23: Metricide 14 concentrate d8: DESCOTON extra d24: Sekusept plus d9: Gigasept® FF(neu) d25: Wavicide-01 e4: d10: ANIOXYDE 1000 d26: SALVAd11: SALVANIOS pH10 NIOS pH7

[c]: Sprays

[d]: Solutions

b25 c5 d1, d25 b1, b2, b3, b4, b5, b7, b8, b9, b10, b11, b12, b13, b16, c1, c2, c3, c5, c7, c8, c14, c15, c16, d1, d3, d4, d5, d6, d7, d8, d9, d10, d11, d12, b18, b19, b24, b25, b26, b27, b28, b29, b30, b31, b32, b33 c17, c18, c19 d15, d26, d27, d28, d29 b1, b2, b3, b4, b5, b7, b8, b9, b10, b11, b12, b13, b16, c1, c2, c3, c5, c7, c8, c14, c15, c16, d1, d4, d5, d6, d7, d10, d11, d12, d15, d26, b18, b19, b24, b25, b26, b27, b28, b29, b30, b31, b32, b33 c17, c18, c19 d28, d29 d1, d2

Linear

a1, a2, a3, a4, a5, a6, a7, a9, a10 a1, a3, a4, a5, a6, a7, a9, a10

b1, b2, b3, b4, b5, b7, b8, b9, b10, b11, b12, b13, b16, c1, c2, c3, c4, c5, c7, c8, c14, c15, b18, b19, b24, b25, b26, b27, b28, b29, b30, b31, b32, b33 c16, c17, c18, c19

d1, d2, d3, d4, d5, d6, d7, d8, d9, d10, d11, d12, d13, d14, d15, d26, d27, d28, d29

e1 e1, e2 e1, e2

e1, e2

b4, b5, b13, b14, b15, b16, b17, b18, b25, b26, b31

c2, c9

d1, d2, d6, d12, d13, d14, d15, d28, d29

a9

b1, b4, b5, b11, b13, b16, b18, b19, b24, b25, b26, b27, b28, b29, b30, b31, b32, b33

c1, c3, c14, c15, c16, c17, c18, c19

d12, d28

a9, a10

b13, b25, b29, b30, b31, b32, b33

c7, c16, c18, c19

d28, d29

L14-5sp

a1, a3, a4, a5, a6, a7

b4, b5, b13, b14, b15, b16, b17, b18, b26, b32, b33

c2, c9

d1, d2, d6, d12, d13, d14, d15

e1, e2

L14-5WU/L14-5WE/L14-5Ws

a1, a3, a4, a5, a6, a7

b4, b5, b13, b14, b15, b16, b17, b18, b26, b32, b33

c2, c9, c11

d1, d2, d6, d12, d13, d14, d15

e2

L20-5U/L20-5s/L20-5E L12-3RCs/L12-3VNs L13-3WE/L13-3WU/L13-3Ws/L15-3WE/L15-3WU/ L15-3Ws/L18-5WU/LM18-5WU/LM24-6WU

L30-8U/L33-8U/L33-8s

a8

P7-3/P7-3s/P7-3E/P7-3U/P7-3P P12-4/P12-4s

Phased

SP5-1U/SP5-1s/SP5-1E/SP5-1 SP5-1Ns/SP5-1N LFP5-1s/LFP5-1U/LFC5-1s/LFC5-1U

P8-2s/P8-2/P8-2U/P8-2P/SP9-2U/SPM6-1U/XP5-1U

e1, e2

d2 c18, c19

L9-3PAU P4-2/P4-2s/P4-2E/P4-2NE/P4-2Ns/P10-4E/ P10-4s/P10-4U/P10-4/2P2/2P2s/2P2P

a1, a2, a3, a4, a5, a6, a7, a9, a10 a1, a8 a1 a1, a2, a3, a4, a5, a6, a7, a9, a10 a1, a2, a3, a4, a5, a6, a7, a9, a10 a10 a1, a2, a3, a4, a5, a6, a7, a9, a10

b1, b2, b3, b4, b5, b7, b8, b9, b10, b11, b12, b13, b16, c1, c2, c3, c4, c5, c7, c8, c14, c15, b18, b19, b24, b25, b26, b27, b28, b29, b30, b31, b32, b33 c16, c17, c18, c19 b3, b4, b15, b25, b29

c2, c4, c5, c16

b5, b25, b29

c1, c2, c5, c16

b1, b2, b3, b4, b5, b7, b8, b9, b10, b11, b12, b13, b16, c1, c2, c3, c5, c7, c8, c14, c15, c16, b18, b19, b24, b25, b26, b27, b28, b29, b30, b31, b32, b33 c17, c18, c19 b1, b2, b3, b4, b5, b7, b8, b9, b10, b11, b12, b13, b16, c1, c2, c3, c5, c7, c8, c14, c15, c16, b18, b19, b24, b25, b26, b27, b28, b29, b30, b32, b33 c17, c18, c19 b1, b4, b5, b11, b13, b16, b18, b19, b24, b26, b27, b28, c1, c3, c14, c15, c17, c18, c19 b32, b33

d1, d2, d3, d4, d5, d6, d7, d8, d9, d10, d11, d12, d13, d14, d15, d26, d27, d28, d29

e1, e2

d1, d2, d11, d13, d16, d20, d25

e1

d1, d2, d3, d4, d5, d27

e1

d1, d4, d5, d6, d7, d10, d11, d12, d15, d26, d28, d29 d1, d4, d5, d6, d7, d8, d9, d10, d11, d12, d26, d29

2

e1, e2 e1, e2

d12, d29

b1, b2, b3, b4, b5, b7, b8, b9, b10, b11, b12, b13, b16, c1, c2, c3, c5, c7, c8, c14, c15, c16, d1, d3, d4, d5, d6, d7, d8, d9, d10, d11, d12, b18, b19, b24, b25, b26, b27, b28, b29, b30, b31, b32, b33 c17, c18, c19 d15, d26, d27, d28, d29

Rely+On PeraSafe

[e]: Devices [f]: Powder

e4

L16-4Hs (only for the socket with black cover) LM14-6E/LM14-6s/LM16-4U

[f]: Powder

f1: TrophonSonex-HL (Used with Trophon/ Trophon2) Germitec UV-C Vaporized Hydrogen Peroxide (Used with V-PRO Low Temperature Sterilization System) STERRAD® system

e1, e2

[a]: Cleaners

[b]: Wipes

[c]: Sprays

b32: Super b1: CLEANISEPT® WIPES b16: CaviWipes MetriZyme b17: Dispatch Towels b2: mikrozid® AF SaniTristel Preb18: Accel TB Wipes Cloth® Wipes Jumbo Clean Wipes b33: SANIb19: CaviWipes 1 b3: PROTEXTM DISINa3: Liquinox b20: Tuffle 5 a4: Revital-OX CLOTH® FECTANT Wipes b21: Sani-Cloth Active b4: Sani-Cloth® Plus PRIME Enzymatic b22: Septiwipes b5: SONOTM ULTRAWIPES Detergent b23: Mikorbac Tissues a5: MetriSponge SOUND WIPES a6: Prolystica 2X b7: Tristel Sporicidal Wipes b24: Sani-Cloth Germicidal Wipes Concentrate b8: Tristel Rinse Wipes b9: Clinell Universal Wipes/ b25: WIP'ANIOS Enzymatic CLEAN'UP Clinell® Surface Wipes Cleaner b10: mikrozid® Senb26: CaviWipes XL a7: Endozime b27: OXIVIR™ WIPES sitive Wipes and Endozb28: Oxivir 1 Wipes ime Sponge b11: Wip’Anios premium b12: ultrasound probe b29: PDI SANI-CLOTH a8: klenzyme a9: ANIOSYME 5 cleaning wipes BLEACH WIPES b13: Sani-Cloth AF3 (gray) b30: wip anios excel a10: DDN9 b14: Protex Ultra Wipes b31: Virusolve® + Pronb15: Sani-Cloth HB te all’uso Wipes a1: a2:

Probe Endo-cavity

V11-3/V11-3BE/V11-3B/V11-3WE/ V11-3Ws/V11-3E/V11-3s V11-3HU/V11-3HE/V11-3Hs/V11-3H/V113HB/V11-3HBs/V11-3HBE/SV10-2U

[a]: Cleaners

OxivirTM/MC Tb PI-SPRAY II Surfa’safe TRANSEPTIC PROTEXTM DISINFECTANT SPRAY c7: Tristel Duo c8: IODOCLEAN c9: Protex Spray c10: CaviCide c11: T-Spray c12: Indican Form c13: Transeptic Spray c14: CAVICIDE 1 c15: OXIVIR 1 c16: WIP'ANIOS SPOR'ACTIV c17: Accel TB Liquid c1: c2: c3: c4: c5:

[d]: Solutions

c18: Sani-HyPerCide GERMICIDAL SPRAY c19: Sani-24 GERMICIDAL SPRAY

[b]: Wipes

[e]: Devices

e1: d27: Minncare d12: Cavicide d1: CIDEX OPA d2: Cidex Activated Diliquid Liquid disinfectant aldehyde Solution d13: Metricide d28: Virusolve® d14: Metricide 28 d3: Minncare® Cold d15: Metricide + ConSterilant e2: d4: Ster-Bac centrate OPA Plus d29: Virex II 256 d16: Cidex Plus d5: Triacid-N e3: d17: Gigasept AF d6: Revital-Ox® d18: Osvan Resert® High Level Disinfectant/ d19: Neojodin UltrOx™ High-Lev- d20: Milton d21: hibitane el disinfectant d22: Sterihyde d7: Gigasept® PAA d23: Metricide 14 concentrate d8: DESCOTON extra d24: Sekusept plus d9: Gigasept® FF(neu) d25: Wavicide-01 e4: d10: ANIOXYDE 1000 d26: SALVAd11: SALVANIOS pH10 NIOS pH7

[c]: Sprays

[d]: Solutions

a1, a2, a3, a4, a5, a6, a7, a9, a10 a1, a2, a3, a4, a5, a6, a7, a9, a10

b1, b2, b3, b4, b5, b7, b8, b9, b10, b11, b12, b13, b16, c1, c2, c3, c4, c5, c7, c8, c14, c15, d1, d2, d3, d4, d5, d6, d10, d11, d12, d13, b18, b19, b24, b25, b26, b27, b28, b29, b30, b32, b33 c16, c17, c18, c19 d14, d15, d26, d27, d29 b1, b2, b3, b4, b5, b7, b8, b9, b10, b11, b12, b13, b16, c1, c2, c3, c5, c7, c8, c14, c15, c16, d1, d3, d4, d5, d6, d7, d8, d9, d10, d11, d12, b18, b19, b24, b25, b26, b27, b28, b29, b30, b31, b32, b33 c17, c18, c19 d15, d26, d27, d28, d29

a1, a2, a3, a4, a5, a6, a7, a9, a10

b1, b2, b3, b4, b5, b7, b8, b9, b10, b11, b12, b13, b16, c1, c2, c3, c4, c5, c7, c8, c14, c15, b18, b19, b24, b25, b26, b27, b28, b29, b30, b31, b32, b33 c16, c17, c18, c19

V11-3HBs V11-3Hs (only for the socket with black cover) V10-4/V10-4s/V10-4B/V10-4Bs/V10-4BP/ 6CV1/6CV1s/6CV1P

[e]: Devices [f]: Powder e1, e2, e3 e1, e2

d1, d2, d4, d5, d6, d7, d8, d9, d10, d11, d12, d13, d14 d15, d26, d28, d29

e1, e2, e3

Pencil

d1, d2, d4, d5

Biplane

CB10-4/CB10-4P/CB10-4E

a1, a2, a3, a4, a5, a6, a7, a9

b1, b2, b3, b4, b5, b7, b8, b10, b11, b12, b16, b18, b19, b24, b25, b26, b27, b28, b29, b30, b31

c1, c2, c3, c4, c5, c7, c14, c15, c16, c17, c18, c19

d1, d2, d3, d4, d5, d6, d12, d13, d14, d15, d27, d28

e1, e2, e3

6LB7/6LB7s/6LB7P/6LB7E/65EB10EA

a1, a2, a3, a4, a5, a6, a7, a9

b1, b2, b3, b4, b5, b7, b8, b10, b11, b12, b16, b18, b19, b24, b25, b26, b27, b28, b29, b30, b31 b1, b4, b5, b11, b16, b18, b19, b24, b26, b27, b28, b30, b31

c1, c2, c3, c4, c5, c7, c14, c15, c16, c17, c18, c19

d1, d2, d3, d4, d5, d6, d12, d13, d14, d15, d27, d28

e2, e3

c1, c3, c7, c14, c15, c17

d1, d12, d15, d28

a9

d1, d2, d4

4CD4/4CD4s/D6-2E D7-2/D7-2E/D7-2s/SD8-1E/SD8-1s/SD8-1/ SD8-1U/D6-2/D6-2P/D6-2EA/D6-2B/D6-2A D6-2NE/DL14-3U

a1, a2, a3, a4, a5, a6, a7, a9

b1, b2, b3, b4, b5, b7, b8, b9, b10, b11, b12, b13, b16, c1, c2, c3, c4, c5, c7, c8, c14, c15, b18, b19, b24, b25, b26, b27, b28, b29, b30, b31, b32, b33 c16, c17, c18, c19

a1

d1, d2, d3, d4, d5, d6, d10, d11, d12, d13, d14, d15, d26, d27, d28

e1

d1, d18, d19, d20, d21, d22

e1 e1

4D

D8-2E/D8-2U

b10, b16, b19, b20, b21

c2, c10

d1, d2, d9

D8-4U

b4, b10, b16, b19, b20

c2, c10, c11

d1, d2, d16, d17

c2, c10, c11

d1, d2, d16, d17

b10, b16, b19, b20, b21, b32, b33

DE10-3/DE10-3E/DE10-3U/DE10-3s DE11-3U/DE11-3s/DE11-3E/ DE11-3/DE11-3WE/DE11-3Ws/DE11-3WU DE10-3WU/DE10-3WE (only for the probe with gray strain relief)

Rely+On PeraSafe

e4

CW2s/CW5s/CW5

ELC13-4U/ELC13-4s/ELC10-4

[f]: Powder

f1: TrophonSonex-HL (Used with Trophon/ Trophon2) Germitec UV-C Vaporized Hydrogen Peroxide (Used with V-PRO Low Temperature Sterilization System) STERRAD® system

a1, a2, a3, a4, a5, a6, a7

b1, b2, b3, b4, b5, b7, b8, b9, b10, b11, b12, b13, b16, b18, b19, b24, b25, b26, b27, b28, b32, b33

a8

b1, b12, b15, b16, b20, b21, b22, b23, b24

DE10-3WU/DE10-3WE/DE10-3Ws (only for the probe with white strain relief)

3

c1, c2, c3, c5, c7, c8, c14, c15, c17, d1, d3, d4, d5, d6, d7, d8, d9, d10, d11, d12, c18, c19 d15, d26, d27 c2, c11, c12, c13

d1, d2, d15, d16, d17, d23, d24, d25

c18

d1

f1 f1

e1, e2

f1

e1, e3 e1, e2

f1

Active Ingredients of the Cleaner Cleaner MetriZyme/MetriSponge: Revital-OX Enzymatic Detergent:

Endozime and Endozime Sponge: Prolystica 2X Concentrate Enzymatic Cleaner/klenzyme/ Liquinox/Tristel Pre-Clean Wipes: ANIOSYME 5: DDN9

Disinfectant Active Ingredients

Proteinase substilisin Citric acid, Triethanolamine, Ethanolamine, Ethoxylated coconut oil alkyl amine, Subtilisins (proteolytic enzymes), Glycerine Subtilisins (proteolytic enzymes) enzymatic detergent

ionic surfactants, sequestering agent, stabilising agent, enzymatic complex, Excipients N PROPIONATE, N-DIDECYL-N-METHYLPOLY{OXYETHYL)AMMONIUM TETRAPOTASSIUM ETHYLENEDIAMINETETRAACETATE EDETIC ACID

Active Ingredients of the Disinfectant Disinfectant

Active Ingredients

Tristel Trio Wipes System/Tristel Jet/ Tristel Duo/Tristel Sporicidal Wipes:

chlorine dioxide

IODOCLEAN

sodium thiosulfate and excipients

Ster-Bac/PI-SPRAY II/mikrozid® Quaternary Ammoniums Sensitive Wipes/Clinell Universal Wipes/Sani-Cloth HB/Sani-Cloth Active/T-Spray/Mikorbac Tissues/SaniCloth Germicidal Wipes/SALVANIOS pH7/SALVANIOS pH10/Protex Ultra Wipes/CaviWipes XL/CAVICIDE 1: Tristel Rinse Wipes: deionized water Cidex OPA: 0.55% Ortho-phthladehyde DESCOTON extra/Wavicide-01: glutaraldehyde OxivirTM/MC Tb: 0.5% hydrogen peroxide Sani-Cloth® Plus: n-Alkyl dimethyl benzyl ammonium chloride n-Alkyl ethylbenzyl ammonium chloride CaviWipes: isopropanol, ethylene glycol monobutyl ether (2-butoxyethanol), diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride, water CaviWipes 1: isopropanol, ethanol, ethylene glycol monobutyl ether (2-butoxyethanol), didecyldime-thylammonium chloride, water Dispatch Towels: Sodium hydroxide, Sodium metasilicate, Sodium hypochlorite TM SONO ULTRASOUND WIPES: octyl decyl dimethyl ammonium chloride; dioctyl dimethyl ammonium chloride; didecyl dimethyl ammonium chloride; dimethyl benzyl ammonium chloride Minncare® Cold Sterilant/ 22% Hydrogen Peroxide, 4.5% Minncare liquid disinfectant: Peroxyacetic Acid mikrozid® AF Wipes Jumbo: 25% ethanol; 35% propan-1-ol CLEANISEPT® WIPES: 0.25g didecyldimethylammoniumchloride 0.5g quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl-, chlorides Wip’Anios premium: didecyldimethylammonium chloride 1.4mg/g, polyhexamethylene biguanide hydrochloride 0.96mg/g Cidex Activated Dialdehyde Solution: glutaraldehyde TRANSEPTIC: isopropyl alcohol, chlorhexidine gluconate Protex Spray: Quaternary ammonium compounds diC8-10-alkyldimethyl, chlorides Water

Active Ingredients

Sani-HyPerCide GERMICIDAL SPRAY hydrogen Sani-24 GERMICIDAL SPRAY Quaternary Ammoniums, Ethanol SANI-CLOTH ® PRIME WIPES Quaternary Ammoniums ® Hydrogen peroxide plasma STERRAD system gigasept® FF(neu):

®

gigasept PAA concentrate: ProtexTM Disinfectant Spray/ ProtexTM Disinfectant Wipes:

Triacid-N: Surfa’safe:

®

®

Revital-Ox Resert High Level Disinfectant/TrophonSonex-HL: ANIOXYDE 1000: Sani-Cloth AF3: Metricide OPA Plus: Metricide/Metricide 14/Metricide 28: CaviCide:

Gigasept AF: Rely+On PeraSafe: Cidex Plus: Sonogel: Sterihyde: Osvan: Neojodin: Milton: Hibitane: WIP’ANIOS CLEAN’UP: OXIVIR 1/OXIVIR™ WIPES/ Oxivir 1 Wipes/Accel TB Liquid/Accel TB Wipes: WIP’ANIOS SPOR’ACTIV: PDI SANI-CLOTH BLEACH WIPES: wip anios excel: ®

Virusolve + Pronte all’uso Wipes: ®

Virusolve + Concentrate:

Super Sani-Cloth Virex II 256

®

0.11g succindialdehyde; 0.3g dimethoxytetrahydrofuran; < 5% anionic surfactant; non-ionic surfactants; anticorrosion compounds; fragrance peracetic acid (5%); hydrogen peroxide: acetic acid; potassium hydroxide: corrosion inhibitor octyl decyl dimethyl ammonium chloride; dioctyl dimethyl ammonium chloride; didecyl dimethyl ammonium chloride; dimethyl benzyl ammonium chloride N-Dodecylpropan-1,3-diamin; propan-2-ol; isotridecanol, ethoxylated; non-ionic detergent didecyldimethylammonium chloride 1.4mg/g, polyhexamethylene biguanide hydrochloride 0.96mg/g Hydrogen peroxide 3% Hydrogen Peroxide Quaternary ammonium chlorides. Ortho-phthladehyde Glutaraldehyde isopropanol, ethanol, ethylene glycol monobutyl ether (2-butoxyethanol), diisobutylphe-noxyethoxyethyl dimethyl benzyl ammonium chloride, water didecyldimethylammonium chloride, glycine, aminoalkyl derivs tridecylpolyethylenglycoether. disodium carbonate, citric acid glutaraldehyde carbomer, polyacrylat Glutaraldehyde Ammonia benzalkonium povidone-iodine sodium hypochlorite Hlorhexidine Association of surfactants, excipients Hydrogen peroxide

Registered disinfectants in Canada Drug Identification NO./ License NO.

Name

74736

V-PRO Low Temperature Sterilization System

2981

STERRAD system

®

®

®

02286467

Revital-Ox Resert High Level Disinfectant

100935

Trophon/Trophon2

01963996

Metricide

01964461

Metricide 28

02197170

Wavicide-01

02277484

Minncare liquid disinfectant

02161656

Cavicide Liquid

02247354

Super Sani-Cloth

02517000

SANI-CLOTH ® PRIME WIPES

®

Registered disinfectants in FDA region Registration NO.

Name

FDA K190103 510(k)

V-PRO Low Temperature Sterilization System

Sterilization

K924434

Cidex Activated Dialdehyde Solution

High-level disinfectant and Sterilization

K030004

CIDEX OPA

High-level disinfectant

K923744

Cidex Plus

High-level disinfectant and Sterilization

K080420

Revital-Ox Resert High Level Disinfectant

High-level disinfectant

K103059

Trophon

High-level disinfectant

K173865

Trophon2

High-level disinfectant

K930284

Metricide

High-level disinfectant and Sterilization

K931052

Metricide 28

High-level disinfectant and Sterilization

K140703

Metricide OPA Plus

High-level disinfectant

K914749

Wavicide-01

High-level disinfectant and Sterilization

K954142

STERRAD system

EPA

Microbicidal Method

®

®

®

Sterilization

®

9480-6

Sani-Cloth Plus

Low-level disinfectant

70627-56

Oxivir

TM/MC

Low-level disinfectant

Hydrogen peroxide and peroxyacetic acid mixture stabilized Sodium hypochlorite Didecyldimethylammonium chloride, non-ionic surfactants, sequestering agent, excipients Polycarboxylate, non ionic emulsifier, alcohol, Didecyldimethyl ammonium Chloride, Bis(3-aminopropyl)dodecylamine 2-Aminoethanol, Didecyldimethyl ammonium Chloride, Propan-2-ol, Potassium Carbonate

9480-9

Sani-Cloth AF3 (gray)

46781-8

CAVIWIPES

Low-level disinfectant

46781-6

CAVICIDE

Low-level disinfectant

70627-60

OXIVIR WIPES

46781-12

CAVICIDE 1

9480-4

Super Sani-Cloth

9480-12

SANI-CLOTH PRIME WIPES

Low-level disinfectant

Quaternary Ammoniums

9480-14

Sani-HyPerCide GERMICIDAL SPRAY

Low-level disinfectant

421829-9480

Sani-24 GERMICIDAL SPRAY

Low-level disinfectant

9480-8

PDI SANI-CLOTH BLEACH WIPES

Low-level disinfectant

70627-24

Virex II 256

Low-level disinfectant

Quaternary Ammoniums

4

Tb

™

Low-level disinfectant

Low-level disinfectant Low-level disinfectant ®

®

Low-level disinfectant

•

Cleaning, Disinfecting (Sterilizing) Procedures After completing each examination, clean, disinfect or sterilize the probes as required. If necessary, repeat the cleaning, disinfection (or sterilization) process before next use. When biopsy procedures have been performed, be sure to sterilize the needle-guided bracket. Fail to do so may result in the probe and the needle-guided bracket to becoming sources of infection. Please follow the instructions in the manual for cleaning.

•

WARNING Never immerse the probe connector into liquids such as water or disinfectant, for the connector is not waterproof. Immersion may cause electric shock or malfunction.

–

CAUTION • •

•

No cleaning and disinfecting may result in the probe becoming a source of infection. Please follow the disinfectant manufacturer’s manual for performing cleaning and disinfection, including preparing sterile water and cleaning and disinfection time.

• • • • • • •

• •

Sterilization describes a process that destroys or eliminates all forms of microbial life and is carried out in healthcare facilities by physical or chemical methods.

Probes can be divided into three categories based on their intended use according to the standard ISO 17664-1:2021. Some probes may fall into more than one category (e.g. probes use for biopsy procedures). When selecting a disinfectant, determine the required level of disinfection based on intended use and possibility of cross-contamination. • Non-critical items: come into contact with intact skin only or are devices not intended for direct patient contact. Probes that only come into contact with clean, intact skin are considered noncritical devices and require cleaning after every use. Cleaning may be followed by a lowlevel disinfectant spray or wipe. For details, see “ Processing Non-Critical Probes”. • Semi-critical items: come into contact with mucous membranes. This category includes all endocavity probes - transvaginal, transrectal, and transesophageal (TEE). These semicritical probes must be cleaned with an appropriate cleaner after use followed by high-level disinfection. For details, see “ Processing Semi-Critical Probes”. • Critical items: enter normally sterile parts of the human body. These probes are considered critical and include all intraoperative probes. These probes must be cleaned with an appropriate cleaner after each use, followed by a sterilization process. For details, see “ Processing Critical Probes”.

After the examination, wipe off the ultrasound gel thoroughly. Otherwise, the ultrasound gel may solidify and degrade the image quality of the probe. DO NOT make the probe to become overheated (more than 55 °C) during cleaning and disinfections. High temperature may cause the probe to become deformed or damaged. Observe the illustration graph carefully to immerse the probe. Only soak parts of the probe below the strain relief. Repeated disinfection or sterilization will eventually damage the probe, please check the probe performance periodically. Clean the probe thoroughly in accordance with the cleaning procedure before disinfection or sterilization. For details about probe types, refer the operator’s manuals of the ultrasound system. For details about recommended disinfectants for probes, see the “Cleaner and Disinfectant” table. For use of each disinfectant, please refer to the manufacturer’s instructions. For V-PRO Low Temperature Sterilization System: – The probe should be placed into a STERIS Sterilization Tray and wrapped with sterilization wrap. In Canada/FDA region, the STERIS Sterilization Tray and sterilization wrap should be cleared by the FDA/HC, such as H600 OneStep® sterilization wrap. –

High-Level Disinfection (HLD): Destruction/removal of all microorganisms except bacterial spores.

Selecting a Cleaning, Disinfection/Sterilization Method

NOTE: •

Cleaning is the removal of visible soil (e.g. organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. Thorough cleaning is essential before high-level disinfection and sterilization because inorganic and organic material that remains on the surfaces of instruments interfere with the effectiveness of these processes. Disinfection describes a process that eliminates many or all pathogenic microorganisms, except bacterial spores. – Low-Level Disinfection (LLD): Destruction of most bacteria, some viruses, and some fungi.

How to Select a Processing Method

Semi-critical

Non-critical

Start the sterilization system using the Non Lumen Cycle according to the instructions provided by the manufacturer.

Percutaneous procedure

Body surface

Please select the proper disinfectant for the probe of the Diagnostic Ultrasound System. The content of this document shall prevail in case of other new editions. Refer to local regulations for the use of each disinfectant.

Clean intact skin

Cleaning, Disinfection, and Sterilization Overview

Contaminated intact skin

No cover

Cleaning and disinfection refer to two distinct processes. According to the Centers for Disease Control and Prevention (CDC) “Guideline for Disinfection and Sterilization in Healthcare Facilities” (2008):

Single-use cover

Non-sterile gel

• Cleaning • LLD

5

Non-intact skin

• Cleaning • LLD*

Sterile gel

Needle placement

Percutaneous biopsies

• Single-use cover • Sterility dictated by procedure sterility

Sterile cover

Sterile gel

Critical

Other endocavity use

Transesophageal

Intra-operative

Single-use cover

Sterility dictated by procedure sterility

Sterility dictated by procedure sterility

Sterile or bacteriostatic gel

Sterile gel

Sterile gel

• Cleaning • HLD

• Cleaning • Sterilization

NOTE •

•

This step is to remove the ultrasound gel or other visible dirt. 1. Wear a pair of gloves to prevent infection through the whole processing. 2. Disconnect the probe from the system. If the sheath is used, take off the sheath and discard it. Wipe off the ultrasound gel or other visible dirt on the surface of the probe by using a damp piece of disposable lint-free soft cloth or tissue.

LLD marked with * indicates that those categories must undergo low-level disinfectants that are effective against the mycobacteria and bloodborne pathogens. For details, consider referencing the position statement of the American Institute of Ultrasound in Medicine “Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Transducers and Equipment Between Patients as well as Safe Handling and Use of Ultrasound Coupling Gel” at https://www.aium.org/officialstatements/57. For non-critical probes that require use of cover, if there is a suspected protective cover failure, then they are considered as semi-critical items, and HLD is recommended.

Cleaning Select wipes or detergent to clean the probe. For details about recommended cleaners or disinfectants for probes, see the “Cleaner and Disinfectant” table.

Processing Non-Critical Probes

Cleaning with Wipes Perform the following procedure: 1. Use an approved cleaning or disinfectant wipe, cleaning sponge, or a soft cloth soaked in approved cleaner or disinfectant to clean all surfaces of the probe thoroughly. 2. Dry the probe with a piece of disposable lint-free soft cloth or tissue. Do not dry the probe by heating. 3. Inspect the probe. If visible dirt still exists, repeat the preceding steps to wash the probe until it is all clean.

Processing of non-critical probes requires a two-step process: Cleaning of the probe followed by low-level disinfection.

WARNING Use protective eyewear when disinfecting the probe using sprays. Perform the following procedure: 1. Wear a pair of gloves to prevent infection through the whole processing. 2. Disconnect the probe from the system. If the sheath is used, take off the sheath and discard it. 3. Clean the probe. a. Select an appropriate low-level disinfectant wipe or a piece of disposable lint-free soft cloth soaked with a disinfectant spray. For details about recommended disinfectants for probes, see the “Cleaner and Disinfectant” table. b. Wipe all the surface of the probe according to the wiping duration specified in the operator’s manual provided by the manufacturer. When necessary, clean and disinfect the seams or biopsy guide features by using disposable cotton swabs. 4. Disinfect the probe. Prepare a new low-level disinfectant wipe or a piece of disposable lint-free soft cloth soaked with a disinfectant spray to wipe the probe again. 5. Inspect the probe. If visible dirt still exists, repeat the preceding steps to wipe the probe until it is all clean. 6. Allow the probe to air dry in a clean and well-ventilated place or dry the probe with a piece of disposable lint-free soft cloth or tissue. Do not dry the probe by heating. 7. Check whether the probe has defects such as peeling, rifts, bumps, cracks, or liquid spill. If such defects exist, the probe has reached the end of its service life. In this case, stop using it and contact the Mindray service department. 8. Store the probe in a cool, clean and dry environment.

Cleaning with Detergent Perform the following procedure: 1. Choose an appropriate cleaning agent including mild detergents, and enzymatic. 2. Immerse the probe fully in the cleaning fluid for at least 1 minute or according to manufacturer’s instructions. Lightly clean the probe with a piece of lint-free soft cloth or soft sponge until no dirt is visible. When necessary, clean the seams or biopsy guide features by using disposable cotton swabs. Avoid using a brush to wash the lens because it may damage the probe. Observe the graph here carefully to immerse the probe. Only soak parts of the probe below the strain relief.

Strain relief Probe handle Liquid level Approx.10 mm

Processing Semi-Critical Probes Processing of semi-critical probes requires a two-step process: Cleaning of the probe followed by high-level disinfection. For detailed information on the TEE cleaning and disinfection, see the accompanying TEE manual.

3. Rinse the probe thoroughly by using a large amount of clean water (about 7.5 L/2 gallons) at room temperature for about 1 minute to remove the residual dirt and cleaning solvent. 4. Dry the probe with a piece of disposable lint-free soft cloth or tissue. Do not dry the probe by heating.

Before Processing 6

5. Inspect the probe. If visible dirt still exists, repeat the preceding steps to wash the probe until it is all clean.

Before Processing This step is to remove the ultrasound gel or other visible dirt. 1. Wear a pair of gloves to prevent infection through the whole processing. 2. Disconnect the probe from the system. If the sheath is used, take off the sheath and discard it. Wipe off the ultrasound gel or other visible dirt on the surface of the probe by using a damp piece of disposable lint-free soft cloth or tissue.

High-Level Disinfection Perform the following procedure: 1. Disinfect the probe by using an appropriate high-level disinfectant solution or device. For how to use a high-level disinfectant or device, see the operator’s manual provided by the manufacturer. Prepare a disinfectant by using sterile distilled or softened water when necessary. For details about recommended disinfectants or devices for probes, see the “Cleaner and Disinfectant” table. – Soaking: Immerse the probe head in the disinfectant and shake the probe appropriately to remove any bubbles on the probe surface. For details about the probe immersion duration, see the operator’s manual provided by the manufacturer.

Cleaning Select wipes or detergent to clean the probe. For details about recommended cleaners or disinfectants for probes, see the “Cleaner and Disinfectant” table.

Cleaning with Wipes Perform the following procedure: 1. Use an approved cleaning or disinfectant wipe, cleaning sponge, or a soft cloth soaked in approved cleaner or disinfectant to clean all surfaces of the probe thoroughly. 2. Dry the probe with a piece of disposable lint-free soft cloth or tissue. Do not dry the probe by heating. 3. Inspect the probe. If visible dirt still exists, repeat the preceding steps to wash the probe until it is all clean.

Observe the graph here carefully to immerse the probe. Only soak parts of the probe below the strain relief.

Strain relief Probe handle

Cleaning with Detergent

Liquid level Approx.10 mm

–

Perform the following procedure: 1. Choose an appropriate cleaning agent including mild detergents, and enzymatic. 2. Immerse the probe fully in the cleaning fluid for at least 1 minute or according to manufacturer’s instructions. Lightly clean the probe with a piece of lint-free soft cloth or soft sponge until no dirt is visible. When necessary, clean the seams or biopsy guide features by using disposable cotton swabs. Avoid using a brush to wash the lens because it may damage the probe. Observe the graph here carefully to immerse the probe. Only soak parts of the probe below the strain relief.

Wiping: Use a market disinfection wipe product or sterile disposable lint-free soft cloth wetted with disinfection spray and wipe all surfaces of the probe for a duration according to the manufacturer instructions.

Strain relief

2. Rinse the probe thoroughly by using a large amount of clean water (about 7.5 L/2 gallons) at room temperature for about 1 minute to remove the residual disinfectant. Or follow the disinfectant manufacturer’s instructions regarding rinsing. Dry the probe with a piece of disposable lint-free soft cloth or tissue. Do not dry the probe by heating. 3. Check whether the probe has defects such as peeling, rifts, bumps, cracks, or liquid spill. If such defects exist, the probe has reached the end of its service life. In this case, stop using it and contact the Mindray service department. 4. Store the probe in a cool, clean and dry environment.

Probe handle Liquid level Approx.10 mm

Processing Critical Probes Processing of critical probes requires a two-step process: Cleaning of the probe followed by sterilization. For detailed information on the laparoscopic cleaning and disinfection, see the accompanying laparoscopic manual.

3. Rinse the probe thoroughly by using a large amount of clean water (about 7.5 L/2 gallons) at room temperature for about 1 minute to remove the residual dirt and cleaning solvent. 4. Dry the probe with a piece of disposable lint-free soft cloth or tissue. 7

Do not dry the probe by heating. 5. Inspect the probe. If visible dirt still exists, repeat the preceding steps to wash the probe until it is all clean.

Sterilization For intra-operative probes, they have to be thoroughly cleaned and sterilized after completing each examination. Perform the following procedure: 1. Sterilize the probe by using an appropriate sterilant or device. For details about recommended sterilants or devices for probes, see the “Cleaner and Disinfectant” table. For how to use a device, see the operator’s manual provided by the manufacturer. When using a sterilant, follow the following steps: a. Prepare a sterilant by using sterile distilled or softened water when necessary. b. Immerse the probe head in the sterilant and shake the probe appropriately to remove any bubbles on the probe surface. For details about the probe immersion duration, see the operator’s manual provided by the manufacturer.

Liquid level

Immersion Sterilization (7LT4s as example)

c. Rinse the probe thoroughly by using a large amount of sterile distilled or softened water (about 7.5 L/2 gallons) at room temperature for about 1 minute to remove the residual disinfectant. Or follow the sterilant manufacturer’s instructions regarding rinsing. Dry the probe with a piece of sterile disposable lint-free soft cloth. Do not dry the probe by heating. 2. Check whether the probe has defects such as peeling, rifts, bumps, cracks, or liquid spill. If such defects exist, the probe has reached the end of its service life. In this case, stop using it and contact the Mindray service department. 3. Store the probe in a cool, clean and dry environment.

8