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