Stryker
ACL Workstation Sterilization Try Reprocessing Guide Rev C Oct 2010
Guide
196 Pages
Preview
Page 1
Reprocessing Guide
ACL Workstation Sterilization Tray REF 0234010520
Contents Introduction ... 2 Intended Use of Sterilization Trays... 3 Warnings... 3 Cautions ... 3 Instructions... 4 Sterilization Tray Setup... 10 References ... 11
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Introduction This reprocessing guide provides instructions for the proper cleaning and sterilization of the following sterilization tray: 234-010-520
ACL Workstation Sterilization Tray
234-020-120
Standard Lid
This sterilization tray is intended for use only with the devices listed below. For tray/ device configuration, see the “Sterilization Tray Setup” section of this guide.
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Part Number
Description
234-010-503
Slider, Modular ACL Workstation
234-010-504
Stationary Post, Modular ACL Workstation
234-010-505
Stationary Clamp, Modular ACL Workstation (Qty 2)
234-010-506
Stationary Tensioner, Modular ACL Workstation
234-010-515
Core Drill Holder, Modular ACL Workstation
234-010-001
Bone Plug Suture Drill (Qty 2)
234-010-516
Bone Plug Splitting Block, Modular ACL Workstation
234-010-517
Drill Guide/Graft Sizer, Modular ACL Workstation
234-010-006
Splitting Wedge
234-010-008
Pkg, Plunger Extension-Combination Drill
234-010-502
Muscle Removal Board, Modular ACL Workstation
234-020-085
6mm Sizing Gauge
234-010-507
6.5mm Sizing Gauge
234-020-086
7mm Sizing Gauge
234-010-508
7.5mm Sizing Gauge
234-020-087
8mm Sizing Gauge
234-010-509
8.5mm Sizing Gauge
234-010-002
9mm Sizing Gauge
234-010-510
9.5mm Sizing Gauge
234-010-003
10mm Sizing Gauge
234-010-511
10.5mm Sizing Gauge
234-010-004
11mm Sizing Gauge
234-010-512
11.5mm Sizing Gauge
234-010-005
12mm Sizing Gauge
234-010-513
12.5mm Sizing Gauge
234-010-514
13mm Sizing Gauge
While these instructions have been validated by the manufacturer as being capable of preparing the tray for re-use, it remains the responsibility of the processor to ensure that the reprocessing (as actually performed, using equipment, materials, and personnel in the reprocessing facility) achieves the desired result. This normally requires validation and routine monitoring of the process.
Intended Use of Sterilization Trays Sterilization trays are plastic and/or metal containers used to hold and protect surgical devices during the sterilization process. They consist of an interlocking tray and lid, which are both perforated to allow the passage of sterilizing agent from outside the tray to the devices placed inside. Sterilization trays typically feature a silicon finger mat or group of device holders that secure devices during the sterilization process. Some models feature stacking internal trays to allow the segregation of devices.
Warnings t These instructions are validated only for sterilization of the tray and device(s) identified herein. Using combinations or parameters not described in this manual may result in incomplete sterilization. t These instructions do not replace the cleaning instructions provided with individual devices. Prior to sterilization, clean all devices as specified in their respective user manuals. t Wear appropriate protective equipment (gloves, eye protection, etc.) when reprocessing any medical device. t Both the device and the tray must be cleaned prior to sterilization, or incomplete sterilization will result. t The sterilization tray, its lid, and any internal components have been designed and validated for use as a single system. Do not separate components from the system, for use individually or in combination, or incomplete sterilization may result. t Inspect the tray and its components for visible damage, such as cracking or chipping, prior to use. Do not use the tray if it is damaged.
Cautions t Before lifting the tray assembly, verify that the latches connecting the lid to the tray are secure. t The tray is not designed for use as a shipping container. To avoid damage, remove all devices and pack them separately.
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Limitations on Reprocessing
t Proper processing has a minimal effect on the tray. End of life is normally determined by wear and damage due to use. t Do not cross-sterilize the tray. Using multiple sterilization methods may significantly reduce the performance of the tray. t Do not leave the tray in solutions longer than necessary. This may accelerate normal product aging. t Damage incurred by improper processing will not be covered by the warranty.
Instructions Instructions apply to the sterilization tray only. For instructions on how to reprocess the devices, consult their respective instructions for use.
Point of Use
t Wipe excess soil from the tray using disposable paper towels. t If an automated cleaning method will be used, rinse the tray in sterile distilled water immediately after use.
Containment and Transportation
Reprocess device(s) / tray as soon as reasonably practical following use.
Preparation for Manual Cleaning
1
4
Disassemble the tray into its individual components: base, lid, and (if applicable) silicon mat. Prepare an enzymatic detergent1 according to the manufacturer’s recommendations. Wipe the entire tray with a clean cloth dipped in detergent. Immerse the tray in the detergent.
5
Soak the tray in the detergent for 15 minutes.
2 3
1 Cleaning was validated using Enzol® at 1 oz/gal. at 35-40°C.
4
Manual Cleaning
1
Brush t Thoroughly brush the exterior of the tray with a soft-bristled brush, focusing on any mated or rough surfaces. t Using a pipe cleaner and brush, brush and flush the hard-to-reach areas of the tray. t Actuate the tray, brushing any movable parts in their extreme open and closed positions.
2 Cleaning was validated using Renu-Klenz™ at ¼ oz/gal. at 35-40°C.
2
Rinse t Rinse the tray with reverse osmosis/deionized (RO/DI) water at ambient temperature to remove all detergent residues. After all detergent residues have been removed, continue to rinse for a minimum of 30 seconds. t Drain excess water from the tray and dry it using a clean cloth and filtered pressurized air (40 psi). t Visually inspect the tray for cleanliness, paying close attention to hard-to-reach areas. If visible soil remains, repeat steps 1 and 2.
3
Soak t Prepare a non-enzymatic detergent2 according to the manufacturer’s recommendations. t Fully immerse the tray and inject any mated surfaces with at least 50mL of the detergent. t Soak the tray for a minimum of 15 minutes.
4
Brush t Thoroughly brush the exterior of the tray using a soft-bristled brush. t Inject the prepared detergent into any mated surfaces a minimum of five times. t Actuate the tray, brushing any movable parts in their extreme open and closed positions. t Using a pipe cleaner and syringe, brush and flush the hard-to-reach areas of the tray.
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5
Rinse t Thoroughly rinse the tray with ambient RO/DI water until all detergent residue is removed. Flush any crevices five times with a syringe. After the detergent residue is removed, continue rinsing for a minimum of 30 seconds. t Drain the excess water from the tray and dry it with a clean cloth and filtered pressurized air (40 psi). t Visually inspect the tray for cleanliness, paying close attention to hard-to-reach areas.
Automated Cleaning
1
Rinse t Disassemble the tray into its individual components: the base, lid, and (if applicable) silicon mat. t Rinse the tray with RO/DI water at ambient temperature until there is no visible detergent residue. Use a syringe to assist in rinsing. After all detergent residues have been removed, continue to rinse for a minimum of 30 seconds. t Place the tray in the washer on an incline to facilitate drainage.
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2
Automated wash t Program the washer using the settings below.
Recirculation Time
Water Temperature
Detergent (type and concentration)
Pre Wash
2 min.
Cold tap water
-
Enzyme Wash
2 min.
Hot tap water
Enzymatic Detergent3
Wash 1
2 min.
Set point 60°C (140°F)
Non-enzymatic Detergent4
Rinse 1
2 min.
Heated 60°C (140°F)
-
Dry Phase
7 min.
Drying Temperature
-
3 Cleaning was validated using Enzol® at 1 oz/gal. 4 Cleaning was validated using Renu-Klenz™ at ¼ oz/gal.
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115°C (239°F)
Drying t Remove the tray from the washer after the completion of the dry phase. t Dry the tray using a clean soft cloth. Use filtered pressurized air (40 psi) to assist in drying. t Visually inspect the tray for cleanliness, paying close attention to hard-to-reach areas.
Maintenance
t No routine maintenance is required for the sterilization tray.
Inspection and Testing
t Inspect the tray for dents and cracks. If a problem is observed or suspected, the tray should be returned for repair. t Inspect all components for cleanliness. If fluid or tissue buildup is present, repeat the above cleaning and disinfection procedures.
Packaging for Sterilization
t Double-wrap the tray unless otherwise noted below.
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Sterilization
Warning: Assembled instruments will not sterilize completely. Disassemble all instruments prior to placement in the tray for sterilization. t Prepare the device(s) and the sterilization tray as indicated in the “Sterilization Tray Setup” section below. t Sterilize the device(s) inside the tray according to the parameters indicated below.
Autoclave (Steam) Gravity
Prevacuum
“Flash” Prevacuum
Wrapping
double
double
-
Temperature
123°C (253°F)
132°C (270°F)
132°C (270°F)
Time
50 minutes
4 minutes
4 minutes
Dry Time
40 minutes
45 minutes
-
Warning: Drying time depends on several variables, including: altitude, humidity, type of wrap, preconditioning, size of chamber, mass of load, material of load, and placement in chamber. Users must verify that drying time set in their autoclave yields dry surgical equipment. Warning: These instructions were developed using the guidance from AAMI TIR 12, ISO 17665 and AAMI ST79 and Stryker recommends users observe these standards.
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Storage
Trays with non-absorbent liners (such as plastic or silicone-fingered organizing mats) can cause condensate to pool. To preserve sterility, remove devices from standing solution.
Additional Information
N/A
Manufacturer Contact
Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 +1.800.624.2244, +1.408.754.2000 www.stryker.com
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Sterilization Tray Setup Maximum Weight Load (devices and tray combined)
3.85 kg (8.5lbs)
Internal Stacking
No internal stacking is permitted with this tray.
External Stacking
Do not stack other trays or devices on or below this tray.
Accessories
There are no accessories available for use with this tray.
Device Distribution
Devices should be placed in the tray as illustrated below.
Chemical Indicator* Place the chemical indicator ( ) on the upper-left corner of the tray as illustrated in the following picture. Biological Indicator* Place the biological indicator ( ) on the tip of the instrument as illustrated in the following picture. *Note: Placement of the biological or chemical indicator is not required during sterilization of this tray. If, per hospital procedure, placement of an indicator is desired, the recommended placement sites are as follows.
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References t ISO 17664-Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices t ISO 17665-1-Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices t ANSI/AAMI ST77-Containment devices for reusable medical device sterilization t ANSI/AAMI ST79-A comprehensive guide to steam sterilization and sterility assurances in health care facilities t ANSI/AAMI ST81-Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices t AAMI TIR12-Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: a guide for device manufacturers
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ུਜ਼ུ̦ΠτȜ͈ठঀဥͅ၌ဥ̧̭͉́ͥ͂ୋ௮ࡓͤ͢ͅબफ͙̳̦́Ȃ ੜၑ൚৪͉ठੜၑ̦ष࣐ͩͦͥͅঔ୭͈ܕܥȂऺၳȂ૽֥ͤ͢ͅຈါ̈́ࠫض ̦ං̭ͣͦͥ͂ͬু͈ͣୣහ̞̯̺̩̱́̀ږȃ̷͉ͦͅુȂίυΓΑ͈ બ͂ુഎ۬ণ̦ຈါ̯̳͂ͦ͘ȃ
ဥΠτȜ͈ဥഷ ဥΠτȜ͉Ȃশͅشٸဥͬߓܕවͦ̀༗ࢌ̳ͥ࿒എ́ঀဥ̯ͦͥȂ ίρΑΙΛ·̹͉͘߄௺ୋ͈ယ̳́ܕȃͼϋΗȜυΛ·ΠτȜ̤͍̥ͣ͢ڀ ࢹ଼̯ͦȂ̷̸͈ͦͦ̾ळ̈́ࢢ̱ͬ̀ΠτȜͅවͥस́ΠτȜ ඤ͈ͬߓܕ̧́ͥॽழ͙̳́ȃ ဥΠτȜ͉ͅુȂੜၑಎͅࡥͬߓܕ̳ͥΏςȜϋୋέͻϋ΄Ȝ ζΛΠ̹͉͘ΟΨͼΑγσΘȜ̢̦̳ͣͦ͘ȃΑΗΛ·خෝ̈́ඤ໐ΠτȜ ͤ͢ͅȂࡢș͈ڞͬߓܕၗ̧́ͥܥਅ̜̳ͤ͘͜ȃ
࠙࣬ t ̭͈ͦͣਜ਼͉Ȃུ́අ̳ͥΠτȜ̤͍͈͢ߓܕ̞͈͙̾̀ͅ બफ͙̳́ȃུ́া̱̞̞̀̈́ழ̵͙ࣣͩ͞ΩριȜΗͬঀဥ̳ͥ͂Ȃ ̦ະ̷̤̦̜̳ۖ͂̈́ͥͦͤ͘ȃ t ̭͈ͦͣਜ਼͉Ȃࡢș͈·͈௺ັͅߓܕςȜΣϋΈਜ਼ͅఢ͈ͩͥ͜ ̵͉̜́ͤͭ͘ȃஜͅȂ̳͓͈̀ͬߓܕȂڂ൚̳ͥξȜΎȜζΣν ͺσ͈ঐা̱̩̺̯̞ͤ̀ͅȃ t ֓ၷͬߓܕठੜၑ̳ͥष͉ͅȂనȂ༗ࢌޢ܉൝͈ഐ୨̈́༗ࢌߓͬဥ ̱̩̺̯̞̀ȃ t ஜ͂ͅߓܕΠτȜ͈ၰ༷̱̩̺̯̞ͬ̀ȃ̱̤̥̞̀̈́͂Ȃ ̦ະ̳ۖ̈́ͤ͘ͅȃ 1͈̾ΏΑΞθ̱͂̀ঀဥ̯ ͈̾ΏΑΞθ̱͂̀ঀဥ̯ t ဥΠτȜȂ̷͈ڀȂ̤͍͢ඤ໐ࢹ଼໐͉1͈̾ΏΑΞθ̱͂̀ঀဥ̯ ̭ͦͥ͂ͬփ̱̀୭ࠗȂબ̯̞̳ͦ̀͘ȃࢹ଼໐ͬΏΑΞθ̥ͣၗ ̱̀ࡢ༆ͅȪ̹͉͘༆ഷழ̵͙ࣣͩ̀ȫঀဥ̱̞̩̺̯̞̈́́ȃ̦ະۖ ̳̜̦̈́ͥͤͦ͘ͅޔȃ t ঀဥஜͅȂΠτȜ̷͈͞ࢹ଼໐ܹͅႨ͞ญၗ͈̈́̓෫అ̦̞̥̈́ণ ́ത̱̩̺̯̞̀ȃ෫అ͈͛ͣͦͥΠτȜ͉ঀဥ̱̞̩̺̯̞̈́́ȃ
ಕփ t ̹̞ັ͈ڀΠτȜ̻ͬષ̬ͥष͉ͅȂ͂ڀΠτȜ̪ͬ̾̈́ρΛΙ̦̱̽ ̥ͤࡥ̯̞̭ͦ̀ͥ͂ͬমஜ̞̯̺̩̱̀ͅږȃ t ུΠτȜ͉Ȃเဥ͈ယঀ͈̱̀͂ܕဥͬփ̱̀୭̵̯̞ࠗͦ̀ͭ͘ȃ అੱ̫̹ͬͥ͛Ȃ̳͓͈̱̀ͤ৾ͬߓܕȂ༆șͅ༫̱̩̺̯̞̀ȃ
169
ठੜၑ̤̫ͥͅଷࡠ
t ഐ୨̈́ਜ਼́ੜၑ࣐̠̭ͬ͂ͤ͢ͅȂུΠτȜ ͅဓ̢ͥͬޣג೩ࡘ̧̳́͘ȃ๊֚ͅȂୋ ྵ͉ঀဥฺ̠ͅཹ͂అੱ͈ഽ̥ͣ౯ ̧̳́͘ȃ t ུΠτȜͬໝତ༹͈༷̱̞̩̺̯̞́̈́́ȃ ໝତ༹͈༷̳́ͥ͂ȂΠτȜ͈ෝ̦ࡐಠͅ అ̷̤̦̜̳̈́ͩͦͥͦͤ͘ȃ t ུΠτȜͬဣסಎ́ຈါոષͅಿ̩༶౾̱̈́ ̞̩̺̯̞́ȃુͤ͢ୋྵ̦ౣ̩̈́ͥ ̷̤̦̜̳ͦͤ͘ȃ t ະഐ୨̈́ੜၑ֦̳ܳͥͅఅੱ͉༗બచય͂ٸ ̳͈̮̈́ͤ́͘ಕփ̩̺̯̞ȃ
ਜ਼ ̭͈ͦͣਜ਼̦ഐဥུ̯͈͉ͦͥဥΠτȜ͈͙̳́ȃ͈ߓܕڎठੜၑ ਜ਼̞͉̾̀ͅȂ̷̸͈ͦͦঀ͈ߓܕဥ୰ྶͬ४ચ̱̩̺̯̞̀ȃ
ঀဥশ
t ঀ̞͈̀βȜΩȜΗσ́ȂΠτȜ̥ͣఱ ̧̧̳̈́ͦͬ৾ͤ͘ȃ t ু൲༹ͬဥ̞ͥાࣣ͉Ȃঀဥࢃ̳̪ͅΠ τȜͬၣକ̨̳̳̳́͘ȃ
༗͍̤͢ۯ
͂ߓܕΠτȜ͉Ȃঀဥࢃ̧́ͥࡠͤଇ௸ͅठੜ ၑ̱̩̺̯̞̀ȃ
ဥ͈
1
ΠτȜུͬఘ ȂڀȂΏςϋୋζΛΠ)̱̜͜! ͦ͊* ͈̈́̓ࢹ଼໐ٜ̱̳͘ͅȃ
2
ιȜȜ͈ଔͅਲ̽̀ࣖளס1ͬୋ ̱̳͘ȃ ͅס૫̱̹ୄࠩ̈́ື́ΠτȜఘͬୄ ̱̳͘ȃ
3
1·ςȜΣϋΈ͉Ȃ1 oz/gal. ͈Enzol®ͬ35ȡ40°Ćঀဥ ̱̀બफ͙̳́ȃ
170
4 5
ΠτȜͬͅס૫̱̳͘ȃ Π τ Ȝ ͉ Ȃ ̷ ͈ ͘ ͘ 15 ۼ ͅ ס ૫̱̳͘ȃ
ဥ
1
ήρΏ t ࿉ήρΏ́ΠτȜٸ࿂ఘ̩̭̳̳ͬͤ͘͢ȃ ୪ࣣນ࿂͞ல࿂͉ͅඅͅಕփ̱̳͘ȃ t Ωͼί·ςȜȜͬঀ̽̀ΠτȜ͈ͺ·ΓΑ ̱̩̞ͅ໐ͅήρΏ̥̫ͬȂΏςϋΐ̳́ ̨̳̳͘ȃ t ΠτȜ͈خ൲໐͉Ȃडఱٳպ౾́͘൲̥̱ ̀ήρΏ̥̫̳ͬ͘ȃ
2
̨̳̳ t ਔսأഽ͈ݙ૫൫ȟͼϋȪRO/DIȫକͬ ဥ̞Ȃॼסᙨ̦̳͓̀ੰ̯́ͥͦ͘ݲΠ τȜ̨̳̳̳ͬ͘ȃ̳͓͈̀ॼסᙨ͈ੰ ࢃݲȂ̯ͣͅड೩30ຟ̨̳̳̳͘ۼȃ t ΠτȜͬକ୨̱ͤȂୄࠩ̈́ື͂έͻσΗȜ̱ ̹գੀߗܨȪ40psiȫ̳̱̥́͘ۋȃ t ΠτȜ͈ୄ̯ࠩͬ࿒ণത̱̳͘ȃͺ·Γᾼ̱ ̩̞ႀ֖͉ͅඅͅಕփ̱̩̺̯̞̀ȃॼ̦ ͛ͣͦͥાࣣ͉ͅȂਜ਼1͂2ͬठഽ࣐̞̳͘ȃ
3
૫ t ιȜȜ͈ଔͅਲ̽̀ࣖளס2ͬ ୋ̱̳͘ȃ t Π τ Ȝ ͬ ۖ ͅ ૫ ̱ Ȃ ୪ ࣣ ນ ࿂ ͅ ड ೩ 50mL͈ͬסಕව̱̳͘ȃ t ΠτȜ͉Ȃड೩15ۼ૫̱̫̳͘ȃ
4
2·ςȜΣϋΈ͉Ȃ¼ oz/gal. ͈Renu-Klenz™ͬ35ȡ40Ɏ ́ঀဥ̱̀બफ͙̳́ȃ
ήρΏ t ࿉ήρΏ́ΠτȜٸ࿂ఘ̩̭̳ͬͤ͢ ̳͘ȃ t ̱̹ͬסȂ୪ࣣນ࿂ͅड೩5ٝಕව ̱̳͘ȃ t ΠτȜ͈خ൲໐͉Ȃडఱٳպ౾́͘൲̥̱ ̀ήρΏ̥̫̳ͬ͘ȃ t Ωͼί·ςȜȜͬঀ̽̀ΠτȜ͈ͺ·ΓΑ ̱̩̞ͅ໐ͅήρΏ̥̫ͬȂΏςϋΐ̳́ ̨̳̳͘ȃ
171
5
ু൲
1
̨̳̳ t ΠτȜͬਔսأഽ͈RO/DIକ̨̳̳́ͅȂ ॼ͈סᙨ̳͓ͬ̀ੰ̳̱͘ݲȃࢾ͉Ώςϋ ΐͬঀ̽̀5̨̳̳̳ٝ͘ȃॼסᙨ͈ੰ ࢃݲȂ̯ͣͅड೩30ຟ̨̳̳̳͘ۼȃ t ΠτȜ઼ً̥ͣ̈́କͬෳ̱Ȃୄࠩ̈́ື͂ έͻσΗȜ̱̹գੀߗܨȪ40psiȫ̱̥́ۋ ̳͘ȃ t ΠτȜ͈ୄ̯ࠩͬ࿒ণത̱̳͘ȃͺ·ΓΑ ̱̩̞ͅႀ֖͉ͅඅͅಕփ̱̩̺̯̞̀ȃ ̨̳̳ t ΠτȜུͬఘ ȂڀȂΏςϋୋζΛΠ)̱̜͜! ͦ͊*͈̈́̓ࢹ଼໐ٜ̱̳͘ͅȃ t ਔսأഽ͈RO/DIକ́Ȃ࿒ͅࡉ̢ͥॼסᙨ ̦̩̈́̈́ͥ́͘ΠτȜ̨̳̳̳ͬ͘ȃΏςϋΐͬ ঀ̞Ą̳̳̑ͬ༞੩̱̳͘ȃ̳͓͈̀ॼס ᙨ͈ੰࢃݲȂ̯ͣͅड೩30ຟ̨̳̳̳͘ۼȃ t ෳକͬ௯ૺ̳̹ͥ͛ΠτȜͬ߹̫̀;ΛΏλȜ ͅව̳ͦ͘ȃ
172
2
ু൲ t ո;́ૄ͈ئΛΏλȜͬ୭̱̳͘ȃ
ठ۪শۼ
କأ
स! ȪΗͼί͂ෛഽȫ
ஜ̞
2
೩͈أକൽକ
-
ࣖள
2
͈ࣞأକൽକ
ࣖளस3
1
2
ΓΛΠεͼϋΠ 60°C
ࣖளस4
̨̳̳1
2
ح60°C
-
ۋ
7
ۋأഽ 115°C
-
3·ςȜΣϋΈ͉1 oz/gal.͈Enzol® ͬঀဥ̱̀બफ͙̳́ȃ 4·ςȜΣϋΈ͉¼ oz/gal.͈ Renu-Klenz™ͬঀဥ̱̀બफ ͙̳́ȃ
3
ۋ t ۋ̦ۖၭ̱̹ͣȂΠτȜͬ;ΛΏλȜ ̥̱̳ͣ৾ͤ͘ȃ t ̥̞ͣୄࠩ̈́ື́ΠτȜ̧̳ͬ͘ȃέͻσΗȜ ̱̹գੀߗܨȪ40psiȫ́ۋͬ༞੩̱̳͘ȃ t ΠτȜ͈ୄ̯ࠩͬ࿒ণത̱̳͘ȃͺ·ΓΑ ̱̩̞ͅႀ֖͉ͅඅͅಕփ̱̩̺̯̞̀ȃ
ιϋΞϋΑ
t ̭͈ဥΠτȜ͉ͅȂુഎ̈́ιϋΞϋ Α͉ຈါ̵̜ͤͭ͘ȃ
ത͂ΞΑΠ
t ΠτȜ̭͙ܹ͒͞ͅႨ̦̞̥̈́ത̱̳͘ȃ ̥ة։ુ̦͛ͣͦͥાࣣ͞࿚ఴ̦݃ͩͦͥ ાࣣ͉ȂΠτȜͬ༐̱̀ਘၑ̤̺̩ͬ͛ݥ ̯̞ȃ t ̳͓͈̀ࢹ଼໐̦ୄ̜̭ࠩ́ͥ͂ͬത ̱̳͘ȃఘ͞סழ̦ັ̱̞̀ͥાࣣ͉Ȃ ષܱ͈͂કඉ͈ਜ਼ͬठ͍࣐̩̺̽̀ ̯̞ȃ
শ͈༫
t ո́ئඅͅఈ͈ঐা̦̞̈́ࡠͤȂΠτȜͬඵ ਹͅρΛί̱̳͘ȃ
173
࠙࣬ȇழ͙ၛ̹͈͉̀ۖ͘͘ߓܕ̯ͅ ̵ͦͭ͘ȃ͈̹͛ͅΠτȜͅවͦͥஜͅȂ ̳͓͈̀ͬߓܕٜ̱̩̺̯̞̀ȃ t ո͈ئȶဥΠτȜ͈ΓΛΠͺΛίȷ͈ࣜ ͈ਜ਼́Ȃ͍̤͢ߓܕဥΠτȜ͈ͬ ࣐̞̳͘ȃ t ո͈ئૄ̞̀̿ͅܖȂΠτȜඤ͈ߓܕ ̱̳ͬ͘ȃ
ȜΠ·τȜήȪܨȫ ਹႁ౾۟
ஜ૯ߗ
ȶέρΛΏνȷ ஜ૯ߗ
ρΛί
ඵਹ
ඵਹ
-
أഽ
123°C
132°C
132°C
শۼ
50
4
4
ۋশۼ
40
45
-
࠙࣬ȇۋশ͉ۼȂࣞഽȂഽȂρΛί͈ ਅ႒ȂஜੜၑȂΙλϋΨȜ͈ͼΒȂୟशၾȂ ୟश̳ͥऺၳȂΙλϋΨȜඤ͈́౾͈̈́̓་ ତͅջం̱̳͘ȃξȜΎȜ͉Ȃ̤ঀ̞͈ȜΠ ·τȜή́୭̱̹ۋশ́ۼȂۋͬܕܥ ̧̭̞̯̺̩̱́ͥ͂ͬ̀ږȃ ࠙࣬ḙ͈̑ͦͣਜ਼͉ȂAAMI TIR 12ȂISO 17665ȂAAMI ST79͈ͼ΄ڎΘϋᾼै̞̀̿ܖ ଼̯̞̳ͦ̀͘ȃStrykeŕ͉Ȃ̭͈ͦͣܰͬڒਜ਼ ̯̠ͦͥ͢ξȜΎȜͅଔ̱̳͘ȃ
༗ۯ
ݟକρͼȜȪίρΑΙΛ·̹͉͘ΏςȜ! ϋୋέͻϋ΄Ȝ͈̜ͥ༗ۯζΛΠ̈́̓ȫ͈ັ ̞̹ΠτȜ͉́ࠫႺ̷͈̹̤̦̜̳ͥͦͤ͘͘ȃ! ͬ༗̹̾͛Ȃ̹̹̽ͤ৾ͬ͘ߓܕ̥ͣס ̱̩̺̯̞̀ȃ
ૂح༭
ڂ൚̱̈́
174
ୋ௮ࡓႲ၁୶
Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 ,1.800.624.2244, ,1.408.754.2000 www.stryker.com
175
ဥΠτȜ͈ΓΛΠͺΛί ! ఱਹၾك ड )͂ߓܕΠτȜ͈ࣣࠗ*
3.85kg
ඤ໐͈́ୟ͙ਹ͇
̭͈ΠτȜ͉́Ȃඤ໐͈́ୟ͙ਹ̵̧͇͉́ͭ͘ȃ
ٸ໐͈́ୟ͙ਹ͇
ུΠτȜͬఈ͈ΠτȜ͂͞ߓܕਹ͇̞̩̺̯̞̈́́ȃ
ັ௺
ུΠτȜͅঀဥ̧́ͥັ௺̵͉̜ͤͭ͘ȃ
͈ߓܕ౾
͉ߓܕȂئ͈̠͢ͅΠτȜͅව̩̺̯̞ͦ̀ȃ
ͼڠاϋΐΉȜΗ+ ͼڠاϋΐΉȜΗȪ ȫ͉Ȃئ͈̠͢ͅΠτȜ ͈ऒષߛͅ౾̱̳͘ȃ ڠഎͼϋΐ ΉȜΗ+
ڠഎͼϋΐΉȜΗȪ ߓ͈୶ͅ౾̱̳͘ȃ
ȫ͉Ȃئ͈̠͢ͅܕ
ಕȇڠഎ̹͉͘ͼڠاϋΐΉȜΗ͈౾͉ȂུΠτȜ͈ಎͅຈଌ̵͉̜́ͤͭ͘ȃ ພ͈֭ਜ਼ͅਲ̽̀ȂͼϋΐΉȜΗ͈౾̦བ̱̞͘ાࣣȂଔ̯̞ͦ̀ͥ౾໐պ͉ո͈ئ ̳ͤ́ȃ +
176