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Cleaning - Disinfection - Sterilisation

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<strong>Cleaning</strong> |<br />

<strong>Disinfection</strong> | Sterilization<br />

Quick Reference Guide<br />

<strong>Disinfection</strong>


Content<br />

Endoscopes 4<br />

Fiberoptic Light Cables 6<br />

Sheaths and Obturators 6<br />

Camera Head 8<br />

Shaver Handpiece – Drill Handpiece – Sagittal Saw 10<br />

Device Consoles 12<br />

Notes 13<br />

3


Endoscopes<br />

AR-3350-*<br />

AR-3351-*<br />

AR-3355-*<br />

AR-3200-*<br />

AR-30*AW<br />

AR-30*AWR<br />

AR-31*AW<br />

<strong>Cleaning</strong> and <strong>Disinfection</strong> (See Also DFU-0073)<br />

It is recommended that endoscopes be reprocessed after use as soon as is<br />

reasonably practical. They can be cleaned manually or in an automatic washer<br />

by using a detergent. Gentle washing cycles with suitable cleaning agents and<br />

disinfectants should always be used for rigid endoscopes. Preference should<br />

be given to cleaners with a neutral pH (e.g. enzymatic cleaners). The instructions<br />

of the manufacturer of the cleaning machine, cleaning agent and disinfectant<br />

must be followed. The cleaning and disinfectant result must be confirmed<br />

by the machine, cleaning agent and disinfectant manufacturers in cooperation<br />

with the user. Always store endoscopes securely and transport them in a<br />

closed container to prevent damage to the endoscopes and contamination of<br />

the environment.<br />

NOTE<br />

Prior to cleaning, remove the<br />

two adapters from the light inlet port.<br />

CAUTION<br />

Endoscopes must not be cleaned in an ultrasonic cleaning unit bath under<br />

any circumstances.<br />

<strong>Cleaning</strong> Process<br />

■■Pre-rinse with cold water for 1 minute → Drain<br />

■■Pre-rinse with cold water for 3 minutes → Drain<br />

■■Clean with 0.5 % alkaline cleaning agent for 5 minutes at 55 °C (131 °F)<br />

or with 0.5 % enzymatic cleaning agent at 45 °C (113 °F) → Drain<br />

■■Neutralize for 3 minutes with warm tap water (


Fractionated Prevacuum Procedure<br />

Temperature<br />

Duration<br />

Arrangement<br />

Drying<br />

132 - 137 °C (270 - 278 °F)<br />

Minimum 3 minutes<br />

Double-wrapped<br />

Minimum 10 minutes<br />

Method 2: Hydrogen Peroxide Sterilization (STERRAD Procedure)<br />

Endoscopes can be sterilized by the following hydrogen peroxide methods:<br />

STERRAD Systems<br />

■■STERRAD 100S, short cycle<br />

■■STERRAD NX, short cycle<br />

■■STERRAD 100NX, standard cycle<br />

Observe specifications of the manufacturer (ASP, advanced sterilization<br />

products) regarding the corresponding method.<br />

Steris Systems<br />

■■V- Pro ® 1 low-temperature sterilization system<br />

■■V- Pro ® 1 Plus low-temperature sterilization system, non-lumen C system<br />

■■V- Pro ® 1 maX low-temperature sterilization system, non-lumen C system<br />

Observe specifications of the manufacturer Steris regarding the corresponding<br />

method.<br />

Ethylene Oxide Sterilization<br />

The materials of the endoscopes are compatible with ethylene oxide<br />

sterilization.<br />

CAUTION<br />

The endoscopes must not come into contact with metal during steam<br />

sterilization.<br />

CAUTION<br />

Arthrex’s endoscopes which are not marked with the “Autoclave” marking must<br />

not be sterilized with steam. This can cause irreparable damage.<br />

CAUTION<br />

Accelerating the cooling phase can damage the endoscope. Cold water must<br />

not be poured over the endoscopes under any circumstances.<br />

5


Fiberoptic Light Cables<br />

AR-3240-* <strong>Cleaning</strong> and <strong>Disinfection</strong> (See Also 950-0031-00)<br />

Scrub the fiberoptic cable with a soft brush and mild detergent until all visible<br />

contamination has been removed, paying particular attention to any crevices<br />

or seams. Always avoid any harsh materials or detergents that can scratch, or<br />

in any way damage, the optical surfaces on each end of the fiber optic cable.<br />

The light cables should run through a full cycle in a hospital-grade washer.<br />

Parameters<br />

Phase<br />

Recirculation Time<br />

(Minutes)<br />

Temperature<br />

Detergent Type and<br />

Concentration<br />

Pre-wash 1 02:00 Cold tap water NA<br />

Enzyme wash 03:00 Hot tap water<br />

Neodisher ® Mediclean Forte<br />

1.872 g/l (pH 10.5 - 11)<br />

Rinse 1 00:15 Hot tap water 60 °C NA<br />

Drying 06:00 90 °C NA<br />

CAUTION<br />

Do not kink fiber optic light cables.<br />

CAUTION<br />

Blue light guide cables are not intended to be cleaned using alkaline<br />

cleaners (ph > 10). These blue light guide cables must be cleaned with<br />

enzymatic cleaners and will be damaged by alkaline cleaners.<br />

Steam Sterilization<br />

Method Cycle Minimum Exposure Exposure Time<br />

Temperature<br />

Steam (wrapped) Prevacuum 132 °C (270 °F) 4 minutes<br />

Steam (wrapped) Gravity 132 °C (270 °F) 15 minutes<br />

Steam (unwrapped) Gravity 132 °C (270 °F) 10 minutes<br />

Hydrogen Peroxide Sterilization (STERRAD)<br />

Light guides are compatible with the STERRAD method. Follow the STERRAD<br />

sterilization guidelines.<br />

Sheaths and Obturators<br />

AR-3370-*<br />

AR-3371-*<br />

AR-3372-*<br />

AR-3373-*<br />

AR-3375-*<br />

AR-3380-*<br />

AR-3300<br />

AR-3301<br />

AR-30*Q<br />

AR-3115Q*<br />

<strong>Cleaning</strong> and <strong>Disinfection</strong> (See Also DFU-0073)<br />

It is recommended that endoscopic instruments be reprocessed after use as<br />

soon as is reasonably practical. They can be cleaned manually or in an automatic<br />

washer with the use of a detergent. Gentle washing cycles and suitable<br />

cleaning agents and disinfectants should always be used for rigid endoscopic<br />

instruments. Preference should be given to cleaners with a neutral pH (e.g.<br />

enzymatic cleaners). The instructions of the manufacturer of the cleaning<br />

machine, cleaning agent and disinfectant must be followed.<br />

6


The cleaning and disinfectant result must be confirmed by the machine, cleaning<br />

agent and disinfectant manufacturers in cooperation with the user.<br />

For endoscopic medical instruments having a stopcock, all parts of the stopcock<br />

should be disassembled before cleaning.<br />

<strong>Cleaning</strong> Process<br />

■■Pre-rinse with cold water for 1 minute → Drain<br />

■■Pre-rinse with cold water for 3 minutes → Drain<br />

■■Clean with 0.5 % alkaline cleaning agent for 5 minutes at 55 °C (131 °F) or<br />

with 0.5 % enzymatic cleaning agent at 45 °C (113 °F) → Drain<br />

■■Neutralize for 3 minutes with warm tap water (


Camera Head<br />

AR-3210-0001<br />

AR-3210-0003<br />

AR-3210-0004<br />

AR-3210-0007<br />

AR-3210-0021<br />

AR-3210-0022<br />

AR-3210-0023<br />

AR-3210-0025<br />

AR-3210-0026<br />

AR-3210-0028<br />

CAUTION<br />

Disconnect the camera head from the camera control unit (CCU) prior to all<br />

cleaning. If the camera head is dented or damaged or the connection sleeve is<br />

torn do not autoclave or immerse it in water. Do not place the camera head or<br />

the accessories in an ultrasound bath.<br />

<strong>Cleaning</strong> and <strong>Disinfection</strong><br />

(See Also 950-0032-00, 950-0041-00, 950-0046-00)<br />

Immediately after use, place the camera head assembly in a container and<br />

soak with enzymatic cleaning solution (e.g. Enzol, Metrizyme or equivalent<br />

solution diluted to proper concentrations according to the instructions of the<br />

cleaning solution manufacturer) in order to prevent blood, protein and other<br />

contaminants from drying onto the camera head.<br />

1. Transfer the camera head into the washer for processing.<br />

2. Make sure the camera head is securely fixed to the unit’s trays or baskets.<br />

Make sure the camera head does not touch other instruments.<br />

3. Do not overload the washer.<br />

4. Remove the camera heads immediately after the automatic procedure has<br />

stopped.<br />

5. Set up and run washer for the wash cycle listed below.<br />

Automatic Washer Cycle Definition<br />

Phase<br />

Recirculation<br />

Time<br />

Temperature<br />

Detergent Type and<br />

Concentration<br />

(Minutes)<br />

Pre-wash 1 02:00 Cold tap water NA<br />

Enzyme wash 03:00 Hot tap water Enzol ® , 1 oz/gallon<br />

Rinse 1 00:15<br />

Hot tap water 60 °C<br />

(194 °F)<br />

NA<br />

Drying 06:00 90 °C (194 °F) NA<br />

Dry the equipment with a soft cloth. Wipe the card edge connector with 70 %<br />

isopropyl alcohol to remove any residual detergent.<br />

8


CAUTION<br />

Do not allow exposed glass windows to air dry. 70 % isopropyl alcohol may be<br />

applied to glass surfaces with a soft cotton applicator to prevent streaks and<br />

spots. Dry the surfaces thoroughly with a cotton applicator after applying the<br />

alcohol.<br />

CAUTION<br />

Inspect the camera head cable for breaks and cuts. Camera heads with<br />

damaged cables should not be sterilized or disinfected.<br />

NOTE<br />

Do not wind the camera cable up too tightly prior to sterilization (minimum<br />

15 cm loops) and avoid kinking it.<br />

Steam Sterilization<br />

Method Cycle Minimum<br />

Exposure<br />

Temperature<br />

Steam (wrapped)<br />

Prevacuum<br />

procedure<br />

Steam (wrapped)<br />

Prevacuum<br />

procedure<br />

Steam<br />

(unwrapped)<br />

Gravity<br />

procedure<br />

Exposure<br />

Time<br />

Drying Time<br />

132 °C (270 °F) 4 minutes 30 minutes<br />

132 °C (270 °F) 15 minutes 30 minutes<br />

132 °C (270 °F) 10 minutes Not specified<br />

NOTE<br />

Following sterilization, allow the device to cool down for a minimum of<br />

15 minutes.<br />

9


Shaver Handpiece – Drill Handpiece – Sagittal Saw<br />

AR-8330F<br />

AR-8330H<br />

AR-8330RH<br />

AR-8332H<br />

AR-8332RH<br />

AR-8340F<br />

AR-8350F<br />

AR-8330SJ<br />

The following applies to all shaver handpieces.<br />

<strong>Cleaning</strong><br />

The protective cap must be screwed onto the plug tightly.<br />

Additionally remove the suction regulator as shown.<br />

Options:<br />

a<br />

b<br />

Sterilization<br />

The suction regulator must be completely opened and the protective cap must<br />

be screwed tightly onto the plug.<br />

NOTES on Preparation for <strong>Cleaning</strong><br />

If applicable, remove any accessories and cables from the handpiece.<br />

Open all suction regulators and chucks.<br />

Manual <strong>Cleaning</strong> / <strong>Disinfection</strong><br />

(See Also DFU-0154, DFU-0149 and DFU-0240)<br />

1. Rinse and clean as soon as possible after use.<br />

2. Brush the device off thoroughly with a clean, soft brush moistened with a<br />

mild, pH-neutral cleaning agent. Do not use any sharp materials which might<br />

scratch or damage the surface of the product.<br />

3. Remove blood, deposits and stains thoroughly.<br />

4. Do not immerse the product in cleaning solution.<br />

5. <strong>Cleaning</strong> the cannulated segment:<br />

a. Insert the wire end of a cleaning brush through the cannulation.<br />

b. Pull the brush through completely and repeat until all soiling is removed.<br />

6. Move all of the device’s moving parts to ensure all residue has been<br />

removed. If there is any residue, clean the device again.<br />

7. Point the tip of the device downwards and rinse all remaining traces of<br />

cleaning agent off under running water.<br />

10


8. Use demineralized water, if possible, in order to avoid discoloration of the<br />

metals.<br />

9. Shake all water drops off the devices and wipe the surfaces with a clean<br />

towel.<br />

Machine <strong>Cleaning</strong> / <strong>Disinfection</strong> (See Also LI2-00012-EN)<br />

Start precleaning as soon as possible after use (see “Manual <strong>Cleaning</strong>”). The<br />

procedure should be performed in a single-chamber cleaning and disinfection<br />

machine. For thermal disinfection, according to the “A0 value” concept, the<br />

requirements of DIN EN ISO 15 883-1 must be followed. If there is any residual<br />

moisture on the handpiece once the procedure has finished, this should be<br />

removed by using filtered compressed air.<br />

Minimum Cycle Parameters<br />

■■Pre-rinse for 2 minutes with cold water at 20 ± 5 °C (68 ± 9 °F).<br />

■■Clean for 3 minutes (enzymatic or mild alkaline pH 8 - 10.5)<br />

at 60 ± 5 °C (140 ± 9 °F).<br />

■■Rinse for 15 seconds at 60 ± 5 °C (140 ± 9 °F).<br />

■■Hot rinse cycle for 1 minute at 80 ± 5 °C (176 ± 9 °F).<br />

■■Drying phase for 6 minutes at high temperatures.<br />

NOTE<br />

The following cleaning agents can be used: ENZOL ® Enzymatic, Neodisher ®<br />

Mediclean forte and Thermosept ® alka clean.<br />

CAUTION<br />

Solutions having very low or very high pH levels are not recommended as<br />

they are corrosive to certain metal parts and anodized aluminum and may<br />

damage polymer plastics such as FEP (fluorinated ethylene propylene), ABS<br />

(acrylonitrile butadiene styrene), Ultem, Lexan and Cycolac.<br />

Steam Sterilization<br />

Gravity<br />

Displacement<br />

Steam Sterilization<br />

Cycle<br />

Pre-Vacuum<br />

Cycle<br />

Exposure<br />

Exposure Time Drying Time<br />

Temperature<br />

132 °C – 135 °C<br />

(270 °F – 275 °F)<br />

10 minutes 15 to 30 minutes<br />

121 °C (250 °F) 30 minutes 15 to 30 minutes<br />

132 °C – 135 °C<br />

(270 °F – 275 °F)<br />

4 minutes 20 to 30 minutes<br />

Drying<br />

We recommend a drying cycle of 4 minutes after the autoclave cycles.<br />

11


CAUTION<br />

NEVER allow the plug pins of the shaver console to come into contact with<br />

liquids. Remove dust and moisture with dry compressed air if necessary.<br />

ONLY dry connectors can be connected to the shaver console.<br />

Cooling<br />

The device should not be handled while cooling down.<br />

CAUTION<br />

NEVER place the cable and handpiece in fluids to cool down as this can<br />

damage the cable, the handpiece, the connectors and/or the seals.<br />

Device Consoles<br />

Cart/trolley<br />

Monitor<br />

Camera<br />

console<br />

Shaver console<br />

Fluid<br />

management<br />

console<br />

RF console<br />

Printer<br />

Tablet<br />

Footswitch<br />

<strong>Cleaning</strong> the Unit Surfaces<br />

1. Turn off the power switch and remove the power cable.<br />

2. Allow the unit to cool down to room temperature.<br />

3. Remove dirt and dust with a soft cloth.<br />

4. Remove solid residues with a damp cloth.<br />

Disinfect the Unit Surfaces<br />

The units/consoles can be cleaned/disinfected with conventional surfactants/<br />

surface disinfectants. Always observe the specifications of the surfactant/<br />

disinfectant manufacturer.<br />

CAUTION<br />

The device must cool down to room temperature. Under no circumstances<br />

should the systems be immersed in liquid.<br />

CAUTION<br />

Take care not to scratch the front surface of monitors, touchscreens and<br />

tablets with any hard or abrasive material.<br />

Dust, fingerprints, grease, etc. can be removed with a soft damp cloth (a small<br />

amount of mild detergent can be used with a damp cloth).<br />

12


Notes<br />

13


Notes<br />

14


http://qr.arthrex.de/0tRj | www.arthrex.com<br />

© Arthrex GmbH, 2016. All rights reserved. LI2-00018-EN_B

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