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Reprocessing Guide
45cm Laparoscopic Instruments Sterilization Tray 0250015704
Contents Introduction... 2 Intended Use of Sterilization Trays... 9 Warnings... 9 Cautions... 10 Instructions... 11 Sterilization Tray Setup... 16 References... 18
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Introduction This reprocessing guide provides instructions for the proper cleaning and sterilization of the following sterilization tray: 250-015-704
45cm Laparoscopic Instruments Sterilization Tray
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.
Top Tier Instruments
Place any 11 of these instruments in the top tier of the sterilization tray.
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250-010-310
MULTICUT SCISSORS, STRAIGHT
250-010-311
MULTICUT SCISSORS, CURVED
250-080-130
FIXATION CLAMP 5MM WITH RATCHET
250-080-230
ROTATING HANDLE, W/RATCHET, INSULATED SHAFT
250-080-231
ROTATING HANDLE, RATCHET, INSULATED SHAFT
250-080-233
ROTATING HANDLE, RATCHET, INSULATED/SHAFT
250-080-234
ROTATING HANDLE, W/RATCHET, INSULATED SHAFT
250-080-558
10MM CLIP APPLYING FORCEPS
250-080-595
5MM ROTATING HANDLE, INSULATED SHAFT/ HANDLE 45CM LENGTH
250-080-596
5MM ROTATING HANDLE, W/RATCHET, INSULATED SHAFT 45CM LENGTH
250-080-617
5MM PEEK MONOPOLAR HANDLE
250-080-618
10MM PEEK MONOPOLAR HANDLE
250-080-765
SLIDING LOCK ATRAUMATIC GRASPER, 33CM SINGLE ACTION
250-080-766
SLIDING LOCK ATRAUMATIC GRASPER, 45CM SINGLE ACTION
250-080-767
SLIDING LOCK ATRAUMATIC GRASPER, 33CM DOUBLE ACTION
250-080-768
SLIDING LOCK ATRAUMATIC GRASPER, 45CM DOUBLE ACTION
250-181-106
5MM MULTI-FUNCTION PEEK HANDLE
250-181-107
10MM PEEK MULTI HANDLE
250-181-108
5MM PEEK MULTI HANDLE, 45CM
250-181-164
5MM PEEK HANDLE, 45CM
250-283-033
5MM SHIFT MONOPOLAR HANDLE, 33 CM LENGTH, GLOVE SIZE ≤ 7
250-284-033
5MM SHIFT MONOPOLAR HANDLE, 33 CM LENGTH, GLOVE SIZE ≥ 7.5
250-283-045
5MM SHIFT MONOPOLAR HANDLE, 45 CM LENGTH, GLOVE SIZE ≤ 7
250-284-045
5MM SHIFT MONOPOLAR HANDLE, 45 CM LENGTH, GLOVE SIZE ≥ 7.5
Bottom Tier Instruments
Place any combination of these instruments in the bottom tier of the sterilization tray, provided the total weight of the loaded tray does not exceed 6.53kg (14.40 lbs). 250-040-016
REUSABLE HIGH FREQUENCY BIPOLAR CABLE
250-040-111
MONOPOLAR ELECTROSURGICAL PROBE, SPATULA TIP, 33CM
250-040-112
MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM
250-040-113
MONOPOLAR ELECTROSURGICAL PROBE, J-TIP, 33CM
250-040-116
MONOPOLAR ELECTROSURGICAL PROBE, SPATULA TIP, 45CM
250-040-117
MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 45CM
250-040-118
MONOPOLAR ELECTROSURGICAL PROBE, J-TIP, 45CM
250-080-084
5MM BOWEL GRASPER FORCEPS
250-080-120
BIPOLAR FORCEPS, FENESTRATED, 33CM
250-080-121
BIPOLAR FORCEPS, PADDLE, 33CM
250-080-123
BIPOLAR FORCEPS, FENESTRATED, 33CM
250-080-124
BIPOLAR FORCEPS, PADDLE, 33CM
250-080-131
KNOT PUSHER 3MM OPEN
250-080-132
KNOT PUSHER 5MM OPEN
250-080-133
MYOMA DRILL 5MM LENGTH 320MM
250-080-134
MYOMA DRILL 10MM LENGTH 320MM
250-080-135
PALPATION PROBE GRADUATED 5MM
250-080-136
PALPATION PROBE GRADUATED 5MM 45CM
250-080-137
COHEN INTRAUTERINE CANNULA COMPLETE
250-080-138
COHEN INTRAUTERINE CANNULA ONLY
250-080-139
PORTIO ACORN SMALL ONLY
250-080-140
PORTIO ACORN LARGE ONLY
250-080-154
TROCAR 5.5MM PYRAMIDAL TIP
250-080-155
TROCAR 8.0MM PYRAMIDAL TIP
250-080-156
TROCAR 11.0MM PYRAMIDAL TIP
250-080-157
OBTURATOR, 5.5MM FOR HASSON CANNULA
250-080-158
OBTURATOR, 11.0MM FOR HASSON CANNULA
250-080-171
CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR
250-080-172
CANNULA 8MM AUTOMATIC VALVE STOP COCK, W/O TROCAR
250-080-174
CANNULA, 11MM, AUTOMATIC VALVE STOP COCK, W/O TROCAR
250-080-175
HASSON CANNULA 5.5MM AUTOMATIC VALVE, STOP COCK, OBTURATOR, FIXABLE CONE
250-080-176
HASSON CANNULA, 5.5MM, AUTOMATIC VALVE, STOP COCK
250-080-177
FIXABLE CONE FOR 5.5MM HASSON
250-080-178
HASSON CANNULA , 11MM AUTOMATIC VALVE STOP COCK, OBTUATOR, FIXABLE CONE
250-080-179
HASSON CANNULA, 11MM AUTOMATIC VALVE, STOP COCK
250-080-180
FIXABLE CONE FOR 11MM HASSON
250-080-181
VERESS NEEDLE/ CANNULA, 2.9MM, 120MM
250-080-182
VERESS NEEDLE, 120MM, 2.9MM NEEDLE ONLY 3
Bottom Tier Instruments
Place any combination of these instruments in the bottom tier of the sterilization tray, provided the total weight of the loaded tray does not exceed 6.53kg (14.40 lbs).
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250-080-183
VERESS CANULA, 2.9MM, 120MM, W/2 STOPCOCKES
250-080-200
FASCIA SCREW, 5.5MM
250-080-201
FASCIA SCREW, 11MM
250-080-202
5.5MM - 3MM REDUCER
250-080-203
8MM - 5.5MM REDUCER
250-080-204
12.5/11MM - 5.5 REDUCER
250-080-205
DILATION SET, 5MM-11MM
250-080-206
REDUCER SLEEVE, 11MM 5.5MM
250-080-207
LUERLOCK, MALE, 6MM TUBING
250-080-208
LUER LOCK, FEMALE 6MM TUBING
250-080-210
VERESS NEEDLE, 120MM
250-080-212
VERESS NEEDLE, 120MM BODY ONLY
250-080-235
AXIAL HANDLE, W/RATCHET, INSULATED SHAFT
250-080-236
RING HANDLE
250-080-237
SPRING HANDLE
250-080-240
ALLIS FORCEPS
250-080-241
BABCOCK FORCEPS
250-080-242
PENNINGTON FORCEPS
250-080-243
KOELN FORCEPS
250-080-244
CLAW FORCEPS, SINGLE ACTION
250-080-245
CLAW FORCEPS, DOUBLE ACTION
250-080-246
OP-VIOPSY FORCEPS, SPOON JAW
250-080-247
OPERATING SCISSORS, SERRATED
250-080-248
MARYLAND FORCEPS, CURVED
250-080-249
MIXTER FORCEPS
250-080-250
BABCOCK FORCEPS, PADDLE
250-080-260
HOOK SCISSORS
250-080-261
MINI HOOK SCISSORS
250-080-262
PERITONEAL SCISSORS
250-080-263
METZENBAUM SCISSORS, STRAIGHT, LONG
250-080-264
METZENBAUM SCISSORS, STRAIGHT
250-080-265
METZENBAUM SCISSORS, CURVED LONG
250-080-266
MINI METZENBAUM SCISSORS, CURVED
250-080-267
ENDO METZENBAUM SCISSORS, CURVED
250-080-268
BABY METZENBAUM SCISSORS, CURVED
250-080-269
MICRO SCISSORS, STRAIGHT
250-080-270
MICRO SCISSORS, CURVED
250-080-280
DOLPHIN FORCEPS, SERRATED SPOON
Bottom Tier Instruments
Place any combination of these instruments in the bottom tier of the sterilization tray, provided the total weight of the loaded tray does not exceed 6.53kg (14.40 lbs). 250-080-281
BULLET FORCEPS, TAPERED, SERRATED, SPOON
250-080-282
MARYLAND FORCEPS, CURVED LEFT
250-080-283
KELLY FORCEPS, CURVED LEFT
250-080-284
GRASPER FORCEPS, TISSUE
250-080-285
MIXTER FORCEPS
250-080-286
GRASPER FORCEPS, SERRATED
250-080-287
GRASPER FORCEPS, NARROW JAW
250-080-288
NEEDLE NOSE FORCEPS
250-080-290
BIOPSY FORCEPS, PUNCH
250-080-291
BIOPSY FORCEPS, SPOON W/PIN
250-080-292
BLAKESLY BIOPSY FORCEPS
250-080-293
BLAKESLY BIOPSY FORCEPS, SPOON W/PIN
250-080-312
SCHERTEL FORCEPS, FENESTRATED
250-080-313
BLUNT FORCEPS, BLUNT, SERRATED, SPOON
250-080-314
DEBANEY FORCEPS
250-080-315
FUNDUS FORCEPS
250-080-316
ALLIGATOR FORCEPS
250-080-317
COBRA FORCEPS
250-080-318
SPER FORCEPS, SERRSTED FENESTRATED
250-080-319
33CM DORSEY GRASPER FORCEPS
250-080-320
STRONG FORCEPS, FENESTRATED
250-080-321
BABCOCK FORCEPS
250-080-322
GRASPER FORCEPS, DELICATE, FENESTRATED
250-080-323
GRASPER FORCEPS, ATRAUMATIC
250-080-324
GRASPER FORCEP, BOWEL
250-080-325
MICRO GRASPER
250-080-340
NEEDLE HOLDER, STRIAGHT
250-080-341
NEEDLE HOLDER, CURVED LEFT
250-080-342
NEEDLE HOLDER, CURVED RIGHT
250-080-350
BIPOLAR FORCEPS, FENESTRATED, 45CM
250-080-351
BIPOLAR FORCEPS, PADDLE, 45CM
250-080-360
BIPOLAR FORCEPS, FENESTRATED, 33CM
250-080-361
BIPOLAR FORCEPS, PADDLE, 33CM
250-080-362
BIPOLAR FORCEPS, MICRO TIP, 33CM
250-080-370
5MM INSULATED SHAFT 45CM, FOR BIPOLAR FORCEPS
250-080-371
5MM INSULATED SHAFT 33CM, FOR BIPOLAR FORCEPS
250-080-422
TROCAR, 12.5MM, PYRAMIDAL TIP
250-080-436
CANNULA, 12.5MM AUTOMATIC VALVE, STOP COCK 5
Bottom Tier Instruments
Place any combination of these instruments in the bottom tier of the sterilization tray, provided the total weight of the loaded tray does not exceed 6.53kg (14.40 lbs).
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250-080-472
12.5MM - 10MM REDUCER
250-080-573
5MM INSERT, HOOK SCISSORS, 45CM
250-080-574
5MM INSERT, MINI METZENBAUM SCISSORS, CURVED, 45CM
250-080-575
5MM INSERT, ENDO METZENBAUM SCISSORS, CURVED, 45CM
250-080-577
5MM INSERT, DOLPHIN DISSECTING FORCEPS, SERRATED, SPOON, 45CM
250-080-578
5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM
250-080-579
5MM INSERT, DISSECTING & GRASPER FORCEPS, SERRATED, 45CM
250-080-580
5MM INSERT, BIOPSY FORCEPS, PUNCH, 45CM
250-080-581
5MM INSERT, BIOPSY FORCEPS, SPOON W/PIN, 45CM
250-080-582
5MM INSERT, BIOPSY FORCEPS, BLAKESLY, 45CM
250-080-584
5MM INSERT, ATRAUMATIC GRASPER FORCEPS, SINGLE ACTION
250-080-585
5MM INSERT, ATRAUMATIC GRASPER FORCEPS, DOUBLE ACTION, 45CM
250-080-586
5MM INSERT, BABCOCK GRASPER FORCEPS, 45CM
250-080-587
5MM INSERT, BOWEL GRASPER FORCEPS, 45CM
250-080-588
5MM SHAFT, NEEDLE HOLDER, STRAIGHT, 45CM
250-080-589
5MM SHAFT, NEEDLE HOLDER, CURVED LEFT, 45CM
250-080-590
5MM SHAFT, NEEDLE HOLDER, CURVED RIGHT, 45CM
250-080-591
5MM INSERT, ALLIS SINGLE ROW TEETH
250-080-592
ALLIS DOUBLE ROW TEETH
250-080-619
SEALING CAP
250-080-634
3.5MM CANNULA AUTO VALVE, STOPCOCK, SHORT
250-080-692
3.5MM TROCAR, PYRAMIDAL TIP, SHORT
250-080-693
BIPOLAR HANDLE SEAL
250-080-694
5MM INSERT, RIGHT ANGLE FORCEP, 33CM
250-080-697
5MM INSERT, RETENTION GRASPER, 33CM
250-080-698
5MM INSERT, TENACULUM, 33CM
250-080-699
5MM INSERT, ENDO GRASPER, 33CM
250-080-700
5MM INSERT, PADDLE BABCOCK, 33CM
250-080-701
ENDOLOOP APPLICATOR
250-080-702
ASPIRATION NEEDLE, 33CM
250-080-703
ASPIRATION NEEDLE, 45CM
250-080-725
5MM INSERT, RETENTION GRASPER, 45CM
250-080-726
5MM INSERT, ENDO GRASPER, 45CM
250-080-727
5MM INSERT, PADDLE BABCOCK, 45CM
250-080-728
5MM INSERT, TENACULUM, 45CM
250-080-729
5MM INSERT, RIGHT ANGLE FORCEP, 45CM
250-080-730
3.5MM PYRAMIDAL TROCAR, LONG
250-080-732
5MM, 45CM, INSERT, FENESTRATED FORCEPS
Bottom Tier Instruments
Place any combination of these instruments in the bottom tier of the sterilization tray, provided the total weight of the loaded tray does not exceed 6.53kg (14.40 lbs). 250-080-733
5MM INSERT, PARK FORCEPS
250-080-735
5MM, 45CM, INSERT, FUNDUS GRASPER FORCEPS
250-080-736
5MM, 45CM, INSERT, DORSEY GRASPER FORCEPS
250-080-745
5MM INSERT, 45CM, PARK FORCEPS
250-080-748
5MM INSERT, 45CM, DEBAKEY FORCEPS
250-080-751
5MM X 45CM, INSERT, PERITONEAL SCISSORS
250-080-752
5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW
250-080-753
5MM X 45CM, INSERT, KELLY FORCEPS
250-080-754
FORCEPS, DOUBLE ROW TEETH
250-080-755
5MM X 33CM, INSERT, FENESTRATED GRASPER
250-080-757
5MM X 33CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW
250-080-760
5MM X 33CM INSERT, DISSECTING FORCEPS
250-080-761
5MM X 45CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW
250-080-762
5MM X 45CM INSERT, DISSECTING FORCEPS
250-080-763
5MM X 33CM INSERT, JOHANN FORCEPS
250-080-764
5MM X 45CM INSERT, JOHANN FORCEPS
250-282-000
3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 20CM
250-282-001
3MM INSERT, PERITONEAL SCISSORS, 20CM
250-282-002
3MM INSERT, HOOK SCISSORS, 20CM
250-282-003
3MM INSERT, FUNDUS GRASPER, 20CM
250-282-004
3MM INSERT, ALLIGATOR GRASPER, 20CM
250-282-005
3MM INSERT, NEEDLE NOSE FORCEPS, 20CM
250-282-006
3MM INSERT, SCHERTL GRASPER, FENESTRATED, 20CM
250-282-007
3MM INSERT, COBRA GRASPER, 20CM
250-282-008
3MM INSERT, BLUNT WITH SPOON, GRASPER, 20CM
250-282-009
3MM INSERT, BLUNT GRASPER, 20CM
250-282-010
3MM INSERT, BULLET FORCEPS, 20CM
250-282-046
3MM PEEK MULTI-FUNCTION HANDLE
250-282-047
3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 29CM
250-282-048
3MM INSERT, PERITONEAL SCISSORS, 29CM
250-282-049
3MM INSERT, HOOK SCISSORS, 29CM
250-282-050
3MM INSERT, FUNDUS GRASPER, 29CM
250-282-051
3MM INSERT, ALLIGATOR GRASPER, 29CM
250-282-052
3MM INSERT, NEEDLE NOSE FORCEPS, 29CM
250-282-053
3MM INSERT, SCHERTL GRASPER, FENESTRATED, 29CM
250-282-054
3MM INSERT, COBRA GRASPER, 29CM OBSOLETE
250-282-055
3MM INSERT, BLUNT WITH SPOON, GRASPER, 29CM
250-282-056
3MM INSERT, BLUNT GRASPER, 29CM 7
Bottom Tier Instruments
Place any combination of these instruments in the bottom tier of the sterilization tray, provided the total weight of the loaded tray does not exceed 6.53kg (14.40 lbs). 250-282-057
3MM INSERT, BULLET FORCEPS, 29CM
250-282-058
3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM
250-282-059
3MM INSERT, BIOPSY FORCEPS, 29CM
250-282-060
3MM INSERT, BIOPSY PUNCH, 29CM
250-282-061
3MM INSERT, STRAIGHT NEEDLEHOLDER, 29CM
250-282-096
3MM INSERT, DORSEY GRASPER, 20CM
250-282-097
3MM INSERT, DORSEY GRASPER, 29CM
250-282-099
3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM
250-282-100
3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 20CM
250-282-101
3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM
250-282-102
3MM INSERT, BABCOCK FORCEPS, 20CM
250-282-103
3MM INSERT, BABCOCK FORCEPS, 29CM
250-282-104
3MM X 20CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW
250-282-105
3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW
250-282-109
3MM X 20CM INSERT, DISSECTING FORCEPS
250-282-110
3MM X 29CM INSERT, DISSECTING FORCEPS
250-282-011
3MM INSERT, MARYLAND, FORCEPS CURVED, 20CM
250-282-012
3MM INSERT, BIOPSY FORCEPS, 20CM
250-282-013
3MM INSERT, BIOPSY PUNCH, 20CM
250-282-014
3MM INSERT, STRAIGHT NEEDLEHOLDER, 20CM
250-282-015
3MM PEEK METZENBAUM,CURVED LONG SCISSORS 20CM
250-282-016
3MM PEEK PERITONEAL SCISSOR 20CM
250-282-018
3MM PEEK FUNDUS FORCEPTS 20CM
250-282-020
3MM PEEK NEEDLE NOSE FORCEPS 20CM
250-282-022
3MM PEEK COBRA FORCEPS 20CM
250-282-026
3MM PEEK MARYLAND FORCEPS 20CM
250-282-045
3MM PEEK MONOPOLAR HANDLE
250-282-045
3MM PEEK MONOPOLAR HANDLE
250-282-058
3MM INSERT MARYLAND DISSECTORS 29CM
250-282-099
3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM
250-282-058
3MM INSERT MARYLAND DISSECTORS 29CM
250-282-099
3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM
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. 8
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 • 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. • 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. • Wear appropriate protective equipment (gloves, eye protection, etc.) when reprocessing any medical device. • Both the device and the tray must be cleaned prior to sterilization, or incomplete sterilization will result. • 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. • 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.
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Cautions • Before lifting the tray assembly, verify that the latches connecting the lid to the tray are secure. • The tray is not designed for use as a shipping container. To avoid damage, remove all devices and pack them separately.
Limitations on Reprocessing
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• Proper processing has a minimal effect on the tray. End of life is normally determined by wear and damage due to use. • Do not cross-sterilize the tray. Using multiple sterilization methods may significantly reduce the performance of the tray. • Do not leave the tray in solutions longer than necessary. This may accelerate normal product aging. • 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
• Wipe excess soil from the tray using disposable paper towels. • If an automated cleaning method will be used, rinse the tray in sterile distilled water immediately after use.
Containment and Transportation
Reprocess the tray as soon as reasonably practical following use.
Preparation for Manual Cleaning
1
Disassemble the tray into its individual components: the base, lid, and (if applicable) silicon mat.
2
Prepare an enzymatic detergent1 according to the manufacturer’s recommendations.
3
Wipe the entire tray with the detergent, using a clean cloth.
4
Immerse the tray in the detergent.
5
Soak the tray in the detergent for 15 minutes.
1
Brush
Manual Cleaning
• Thoroughly brush the exterior of the tray with a soft-bristled brush, focusing on any mated or rough surfaces. • Using a pipe cleaner and syringe, brush and flush the hard-to-reach areas of the tray. • Actuate the tray, brushing any movable parts in their extreme open and closed positions.
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2
Rinse • 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. • Drain excess water from the tray and dry it using a clean cloth and pressurized air (40 psi). • 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 • Prepare a non-enzymatic detergent2 according to the manufacturer’s recommendations. • Fully immerse the tray and inject any mated surfaces with at least 50mL of the detergent. • Soak the tray for a minimum of 15 minutes.
4
Brush • Thoroughly brush the exterior of the tray using a soft-bristled brush. • Inject the prepared detergent into any mated surfaces a minimum of five times. • Actuate the tray, brushing any movable parts in their extreme open and closed positions. • Using a pipe cleaner and syringe, brush and flush the hard-to-reach areas of the tray.
5
Rinse • Thoroughly rinse the tray with ambient RO/DI water until all detergent residues are removed. Flush any crevices five times with a syringe. After all detergent residues are removed, continue rinsing for a minimum of 30 seconds. • Drain the excess water from the tray and dry it with a clean cloth and pressurized air (40 psi). • Visually inspect the tray for cleanliness, paying close attention to hard-to-reach areas.
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Automated Cleaning
1
Rinse • Disassemble the tray into its individual components: the base, lid, and (if applicable) silicon mat. • Rinse the tray with RO/DI water at ambient temperature until there is no visible soil. Flush any crevices five times with a syringe. After all visible soil has been removed, continue to rinse for a minimum of 30 seconds. • Place the tray in the washer on an incline to facilitate drainage.
2
Automated wash • 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 115°C (239°F)
-
3
Drying • Remove the tray from the washer after the completion of the dry phase. • Dry the tray using a soft clean cloth. Use filtered pressurized air (40 psi) to assist in drying. • Visually inspect the tray for cleanliness, paying close attention to hard-to-reach areas.
Maintenance
• No routine maintenance is required for the sterilization tray.
Inspection and Testing
• Inspect the tray for dents and cracks. If a problem is observed or suspected, the tray should be returned for repair. • Inspect all components for cleanliness. If fluid or tissue buildup is present, repeat the above cleaning and disinfection procedures.
Packaging for Sterilization
• Double-wrap the tray unless otherwise noted below.
Sterilization
Warning: Do not place inserts, cannulas, or instrument accessories in the top tier of the sterilization tray; otherwise, non-sterile products may result. Warning: Disassemble all instruments prior to placement in the tray for sterilization; otherwise, non-sterile products may result. Warning: Place the stopcock of the devices (where applicable) in the open position prior to sterilization; otherwise, non-sterile products may result. • Prepare the device(s) and the sterilization tray as indicated in the “Sterilization Tray Setup” section below. • Sterilize the device(s) inside the tray according to the following parameters:
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Autoclave (Steam) Prevacuum (U.S.)
Prevacuum (E.U.)
Wrapping
double
double
Temperature
132°C
134°C
(270°F)
(274°F)
Time
4 minutes
3 minutes
Dry Time
60 minutes
90 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.
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
Cleaning was validated using Enzol® at 1 oz/gal. at 35–40°C. Cleaning was validated using Renu-Klenz™ at ¼ oz/gal. at 35–40°C. 3 Cleaning was validated using Enzol® at 1 oz/gal. at 35–40°C. 4 Cleaning was validated using Renu-Klenz™ at ¼ oz/gal. 1 2
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Manufacturer Contact
Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 +1.800.624.4422, +1.408.754.2000 www.stryker.com
Sterilization Tray Setup Maximum Weight Load (devices and tray combined)
6.53 kg (14.40 lbs)
Internal Stacking
Up to two tiers may be stacked inside the tray. Do not stack instruments on top of each other within individual tiers.
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 in the following picture.
Chemical Indicator Place the chemical indicator ( ) in the bottom-right corner of the tray as illustrated in the following picture. Biological Indicator Place the biological indicator ( ) between the jaws of any grasper as illustrated in the following picture.
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Bottom Tier combination of any “bottom tier” instruments (identified in this guide)
Top Tier combination of any 11 “top tier” instruments (identified in this guide)
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References • ISO 17664-Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices • ANSI/AAMI ST81-Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices • ANSI/AAMI ST77-Containment devices for reusable medical device sterilization • ANSI/AAMI ST79-A comprehensive guide to steam sterilization and sterility assurance in health care facilities.
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목차 소개(Introduction)... 272 멸균 트레이 사용 목적(Intended Use of Sterilization Trays)... 279 경고(Warnings)... 279 주의(Cautions)... 279 지침(Instructions)... 280 멸균 트레이 설정(Sterilization Tray Setup)... 285 참고 문헌(References)... 287
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