Reprocessing

Guide

Laparoscope
Sterilization Tray
REF 0233032108
Contents

Introduction.......................................................................................................................................................... 2

Intended Use of Sterilization Trays...................................................................................... 3

Warnings..................................................................................................................................................................... 3

Cautions....................................................................................................................................................................... 4

Instructions............................................................................................................................................................. 4

Sterilization Tray Setup..................................................................................................................... 10

References............................................................................................................................................................ 11

1
 Introduction
This reprocessing guide provides instructions for the proper cleaning and sterilization
of the following sterilization tray:
233-032-108 Laparoscope 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.

HD Autoclavable Laparoscopes
502-539-010 5.0mm 0° 30cm
502-539-030 5.0mm 30° 30cm
502-539-045 5.0mm 45° 30cm
502-859-010 10.0mm 0° 30cm
502-859-030 10.0mm 30° 30cm
502-859-045 10.0mm 45° 30cm
502-503-010 5.5mm 0° 30cm
502-503-030 5.5mm 30° 30cm
502-503-045 5.5mm 45° 30cm
502-103-010 10.0mm 0° 33cm
502-103-030 10.0mm 30° 33cm
502-103-045 10.0mm 45° 33cm
502-329-010 2.9mm 0° 30cm
502-329-030 2.9mm 30° 30cm
Auoclavable Laparoscopes
502-555-010 5.0mm 0° 30cm
502-555-030 5.0mm 30° 30cm
502-555-045 5.0mm 45° 30cm
502-457-010 10.0mm 0° 30cm
502-457-030 10.0mm 30° 30cm
502-457-045 10.0mm 45° 30cm
Laparoscopes
502-585-010 5.0mm 0° 30cm
502-585-030 5.0mm 30° 30cm
502-585-045 5.0mm 45° 30cm

2
 Infrared Laparoscopes
502-540-010 5.0mm 0° 30cm
502-540-030 5.0mm 30° 30cm
502-540-045 5.0mm 45° 30cm
502-860-010 10.0mm 0° 30cm
502-860-030 10.0mm 30° 30cm
502-860-045 10.0mm 45° 30cm

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
• 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.

3
 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 • Proper processing has a minimal effect on the
Reprocessing 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 Reprocess device(s) / tray as soon as reasonably

Transportation practical following use.

Preparation for 1 Disassemble the tray into its individual

Manual Cleaning components: base, lid, and (if applicable) silicon
mat.
2 Prepare an enzymatic detergent1 according to the
manufacturer’s recommendations.
3 Wipe the entire tray with a clean cloth dipped in
detergent.
4 Immerse the tray in the detergent.
Cleaning was validated using
Enzol® at 1 oz/gal. at 35-40°C. 5 Soak the tray in the detergent for 15 minutes.

4
Manual Cleaning 1 Brush
• Thoroughly brush the exterior of the tray with
a soft-bristled brush, focusing on any mated or
rough surfaces.
• Using a pipe cleaner and brush, 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.

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 filtered 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
 5 Rinse
• 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.
• Drain the excess water from the tray and dry it
with a clean cloth and filtered pressurized air (40
psi).
2 Cleaning was validated
using Renu-Klenz™ at ¼ oz/ • Visually inspect the tray for cleanliness, paying
gal. at 35-40°C. close attention to hard-to-reach areas.

Automated 1 Rinse
Cleaning • 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 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.
• Place the tray in the washer on an incline to
facilitate drainage.

6
 2 Automated wash
• Program the washer using the settings below.

Recirculation Water Temperature Detergent

Time (type and
concentration)

Pre 2 min. Cold tap water —

Wash

Enzyme 2 min. Hot tap water Enzymatic

Wash Detergent3

Wash 1 2 min. Set point 60°C Non-

(140°F) enzymatic
Detergent4

Rinse 1 2 min. Heated 60°C —

(140°F)

Dry 7 min. Drying Temperature —

Phase 115°C (239°F)

3 Drying
• Remove the tray from the washer after the
completion of the dry phase.
3 Cleaning was validated • Dry the tray using a clean soft cloth. Use filtered
using Enzol® at 1 oz/gal.
pressurized air (40 psi) to assist in drying.
4 Cleaning was validated
using Renu-Klenz™ at ¼ oz/ • Visually inspect the tray for cleanliness, paying
gal. close attention to hard-to-reach areas.

Maintenance • No routine maintenance is required for the

sterilization tray.

Inspection and • Inspect the tray for dents and cracks. If a problem
Testing 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 • Double-wrap the tray unless otherwise noted

Sterilization below.

7
 Sterilization Caution: Only devices marked “autoclavable” are
compatible with steam sterilization methods.
Using steam sterilization on devices that do not
bear this marking can cause permanent product
damage.

• 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 parameters indicated below.

Ethylene oxide (EtO)

Preconditioning Sterilization Aeration

Temperature 55°C 55°C 55 ± 4°C

(131°F) (131°F) (131 ± 7°F)

Relative Humidity 70% 70% —

Vacuum Set Points 1.30 psia — —

EtO Concentration — 725 mg/L —

(100% EtO)

Time 30 minutes 60 minutes 12 hours

8
 STERRAD®

Sterlize the devices and tray using the STERRAD® 100S system.

Autoclave (Steam)

Gravity Prevacuum “Flash”

Prevacuum
U.S. E.U.

Wrapping double double double —

Temperature 132°C 132°C 134°C 132°C

(270°F) (270°F) (273°F) (270°F)

Time 15 minutes 4 3 4 minutes

minutes minutes

Dry Time 35 minutes 30 30 —

minutes 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 N/A
Information

9
 Manufacturer Stryker Endoscopy
Contact 5900 Optical Court
San Jose, CA 95138 USA
1-800-624-4422
U.S. Patents: www.stryker.com/patents

Sterilization Tray Setup

Maximum Weight 0.82 kg (1.8 lbs)
Load
(devices and tray
combined)

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 ( ) in the bottom-right
corner of the tray as illustrated in the following picture.

Biological Indicator*
Place the biological indicator ( ) on any scope tip 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.

10
References
• ISO 17664—Sterilization of medical devices—Information to be provided by the
manufacturer for the processing of resterilizable medical devices
• 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
• ANSI/AAMI ST77—Containment devices for reusable medical device
sterilization
• ANSI/AAMI ST79—A comprehensive guide to steam sterilization and sterility
assurances in health care facilities
• ANSI/AAMI ST81—Sterilization of medical devices—Information to be provided
by the manufacturer for the processing of resterilizable medical devices
• AAMI TIR12—Designing, testing, and labeling reusable medical devices for
reprocessing in health care facilities: a guide for device manufacturers

11
12
 Produced for
Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 USA
1-800-624-4422
U.S. Patents: www.stryker.com/patents

Stryker® is a registered trademark of Stryker Corporation.

ENZOL® Enzymatic Detergent is a registered trademark
of Advanced Sterilization Products, Division of Ethicon
Inc., a Johnson and Johnson company.
Renu-Klenz™ is a trademark of STERIS corporation.
STERRAD® is a registered trademark of Advanced
Sterilization Products. 2016/02