Stryker
2.0 mm × 7.5 ft Clear Case Fiberoptic Light Cable (Stryker scope and Stryker light source fittings)
Fiber Optic Cables User Guide
288 Pages
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Page 1
Fiber Optic Cables User Guide
Contents E n g l i s h ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . . 3 F r a n ç a i s . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 1 7 D e u t s c h... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 3 3 I t a l i a n o ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 4 9 P o r t u g u ê s ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 6 5 E s p a ñ o l... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 8 1 N e d e r l a n d s . . .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 9 7 D a n s k . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. . . 1 1 3 S u o m i . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. . . 1 2 9 N o r s k .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. . . 1 4 3 S v e n s k a . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. . . 1 5 9 P o l s k i . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. . . 1 7 5 Ε λ λ η ν ι κ ά . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. . . 1 9 1 T ü r k ç e . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. . . 2 0 7 P у с с к и й... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. . . 2 2 3 简 体 中 文 . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. . . 2 4 1 日 本 語 . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. . . 2 5 5 한 국 어 . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. . . 2 7 1
1 Product Description/Intended Use The Fiber Optic Light Cable is composed of a fiber optic bundle, silicone sheath, rubber handle, and two stainless steel connectors. One end of the Fiber Optic Light Cable connects with a light source and the other end connects with an endoscope. The Fiber Optic Light Cable is used with a light source and an adapter/scope to transmit light to a scope in order to conduct a minimally invasive surgical procedure. Note: Match the diameter of the light cable with the endoscope being used to obtain maximum efficiency in light transmission. Fiber Optic Cable
Description
0233–050–064
5.0 mm × 10 ft Clear Case Fiberoptic Light Cable (Storz scope and Stryker light source fittings, screw-on)
0233–050–065
5.0 mm × 10 ft Fiberoptic Light Cable (Stryker scope and Stryker light source fittings)
0233–050–067
2.0 mm × 7.5 ft Clear Case Fiberoptic Light Cable (Stryker scope and Stryker light source fittings)
0233–050–069
5.0 mm × 10 ft Clear Case Fiberoptic Light Cable (Wolf scope and Stryker light source fittings, snap-on)
0233–050–084
5.0 mm × 10 ft Non-Transparent Fiberoptic Cable (Storz scope and Strkyer light source fittings, screw-on)
0233–050–090
5.0 mm × 10 ft Fiberoptic Light Cable (Universal scope and Stryker light source fittings)
0233–065–010
6.5 mm × 10 ft Fiberoptic Light Cable (Wolf scope and Stryker light source fittings)
1.1
Indications
The Fiber Optic Light Cable is indicated for use in minimally invasive surgical procedures where an endoscope and a compatible light source are used.
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1.2
Compatibility
The Fiber Optic Cables covered in this user manual are compatible with all Stryker light sources. (Some light source functions may require specific cables; see the light source user manual for details.) To use another manufacturer’s light source, cable 0233-050-090 must be used with the appropriate light source adapter. Reprocess the light source adapters according to the instructions in this user manual. Ligh t So urce Adapte r
Description
0233–050–071
Stryker/ACMI/Zimmer Light Source Adapter
0233–050–072
Olympus Light Source Adapter
0233–050–073
Storz Light Source Adapter
0233–050–074
Wolf/Dyonics Light Source Adapter
The cable requires a scope adapter to connect to the endoscope. If using cable 0233–050–090, select from the four scope adapters listed below. Reprocess the scope adapters used with cable 0233–050–090 according to the instructions in this user manual. Scope Adapter
Description
0233-050-075
Stryker/ACMI Adapter
0233-050-076
Wolf/Dyonics Adapter
0233-050-077
Storz/Olympus Adapter
0233-060-000
ACMI Universal Adapter
If a cable other than 0233–050–090 is used, select from the six scope adapters listed below, depending on if the endoscope is autoclavable or non-autoclavable.
W a r n i n g : Reprocess the six adapters listed below according to the instructions that are provided with the adapter. See Stryker user manual 1000–400–296. Type of Scope
Scope Adapter
Description
For Autoclavable Scopes
0331-000-100
Stryker Adapter
0331-000-200
Wolf/Dyonics Adapter
0331-000-300
Storz Adapter
0331-000-400
Right Angle Adapter
0233-080-000
Stryker Adapter
0233-082-000
Storz Adapter
For Non-Autoclavable Scopes
EN- 4
2 Warnings and Cautions 1.
Read these instructions thoroughly before using the device.
2.
Before using this device, read the light source user manual for warnings, indications, intended use, and other information about using the light source system.
3.
Federal law (United States of America) restricts this device to use by, or on order of, a physician.
4.
Carefully unpack the device and check if any damage occurred during shipment.
5.
This device is shipped non-sterile. Clean and sterilize the device prior to the first use and after every subsequent use. Follow the cleaning, disinfection, and sterilization instructions provided in this user manual.
6.
Test the device function prior to use. If there is any sign of malfunction, the device should not be used and returned to Stryker for repair evaluation.
7.
Do not abuse, pull, stretch, kink, puncture, or otherwise alter the cable. Doing so will cause irreversible damage to the glass optical fibers, which will impair light transmission through the cable.
8.
The surface temperature near the scope adapter and at the tip of the scope can exceed 41 °C if the light source is operated at high levels of brightness for extended periods of time. The heated scope and adapter can cause burns to the patient, user, or combustible materials.
9.
When operating the light source, never look into the following apertures or direct the light emitted from the apertures toward another person: •
the light cable connection on the light source (if the cable is not attached)
•
the end of the light cable (or scope adapter)
•
the scope tip
10. Never use this equipment in the presence of flammable or explosive gases. 11. Replace the cable if the light transmission is compromised due to damaged fibers or connectors. 12. No modification of this equipment is allowed. The warranty is void if any of these warnings or cautions are disregarded.
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3 Setup Warning Before using the cable with an endoscope, check the outer surface of the endoscope to ensure there are no rough surfaces, sharp edges, or protrusions. Keep fingers away from the light source cable port when inserting the cable, as the clamp may inadvertently deploy and cause injury.
1.
Insert the light source end of the cable into the cable port. •
If using a Stryker light source, turn the lever on the light source clockwise to lock open the cable clamp. The port will automatically tighten when the cable is fully inserted.
•
If using another manufacturer’s light source, the appropriate light source adapter must first be attached to the Universal Fiberoptic Cable (0233-050-090).
2.
Connect the appropriate scope adapter to the endoscope.
3.
Attach the endoscope end of the cable to the scope adapter.
No te: For disassemb ly, fi rst power off the l ight source (or pl ace it in Standb y mode), then follow the instructions ab ove in reverse order. Turn the lever on Stryker light sou rces to rel ease the cab le from the port.
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4 Reprocessing These reprocessing instructions are provided in accordance with ISO 17664, AAMI TIR12, AAMI TIR30, AAMI ST79, and AAMI ST81. While they have been validated by Stryker as being capable of preparing the device 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 routine monitoring and validation of the facility’s reprocessing procedures. Stryker recommends users observe these standards when reprocessing medical devices. Ove rview Reprocessing the cable involves manual or automated cleaning with two different detergents, optional disinfection, and sterilization. •
S t e p 1 (required): Cleaning with Enzymatic Detergent
•
S t e p 2 (required): Cleaning with Non-Enzymatic Detergent
•
S t e p 3 (optional): Disinfection
•
S t e p 4 (required): Sterilization
4.1
Warnings
•
This device must be cleaned and sterilized prior to the first use and after every subsequent use.
•
Use only the sterilization cycles and configurations that were validated and are outlined in this document. Using unspecified sterilization cycles can damage the device or result in incomplete sterilization.
•
Adapters must be removed from the cable prior to cleaning, disinfection, and sterilization.
•
Do not use synthetic detergents or oil-based soaps. These soaps can be absorbed by the device and leach out, causing a tissue reaction.
•
To avoid health risks from aerosol contamination, brush the device only when it is submerged in liquid.
•
Wear appropriate protective equipment: gloves, eye protection, etc.
4.2
Cautions
•
Do not sterilize the device outside of the recommended parameters. Doing so will cause irreversible product damage and will lead to premature replacement of the device.
•
Do not use brushes or pads with metal or abrasive tips during manual cleaning, as permanent scoring or damage could result. EN- 7
•
When brushing, care should be taken around the cable tips to prevent damage to the optical fibers, otherwise light transmission loss can occur.
•
Do not sterilize in sterilization pouches when performing the Sterrad® sterilization process. Doing so can result in damage to the device
•
Do not immerse or rinse the device in cold water or any other cold fluid. This could cause glass fiber breakage which decreases light transmission.
•
Do not use a HIVAC sterilizer. The warranty is void is HIVAC sterilization is used.
4.3
Limitations on Reprocessing
•
Proper processing has a minimal effect on this device. End of life is normally determined by wear and damage due to use.
•
Do not cross-sterilize the device. Using multiple sterilization methods can significantly reduce the performance of the device.
•
Do not leave the device in solutions longer than necessary. This can accelerate normal product aging.
•
Repeated sterilization via Sterrad 100NX® can degrade the product’s cosmetic appearance.
•
Damage incurred by improper processing will not be covered by the warranty.
4.4
Materials and Equipment
All materials and equipment required to reprocess the cable shall be supplied by the user unless otherwise noted. Item
Description
All phases Gloves, eye protection, etc.
Wear protective equipment as required by the medical facility and procedure.
Cleaning Water basin
Large enough to accommodate the device
Enzymatic detergent1
Used in cleaning solution to remove surgical debris
Tap water
To prepare cleaning solutions
Syringe2
To inject detergent into hard-to-reach areas of the device
Soft-bristle brush3
To clean exterior of the device
Reverse osmosis/ deionized water4
To rinse the device
Clean cloth or filtered pressurized air (≤40 psi)
To assist with drying
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Non-enzymatic detergent5
Used in cleaning solution to remove surgical debris
Automated washer
For using the automated cleaning procedure
Disinfection Washer disinfector
To perform thermal disinfection
Sterilization Sterilization system6
•
Steam (Autoclave)
•
Steris®/Amsco® V-PRO® 1, V-PRO 1 Plus, or V-PRO maX
•
Steris System 1®
•
Sterrad 100S, NX®, or 100NX
•
Ethylene Oxide (EO)
Sterilization wrap7,8
To maintain sterile barrier
Sterilization tray8
Optional. Must be compatible with sterilization method.
1 Cleaning was validated using ENZOL® Enzymatic Detergent at 1 oz/gal. of tap water at 35 °C. 2 Cleaning was validated using a 50 mL syringe. 3 Cleaning was validated using an M16 soft-bristle brush. 4 Cleaning was validated using reverse osmosis/deionized (RO/DI) water. 5 Cleaning was validated using Prolystica® 2x Neutral Detergent at 1/8 oz/gal. of tap water at 35 °C. 6 Steris System 1 is not intended for use in the United States. 7 Double wrapping the device during sterilization was validated with Kimberly-Clark® KC600 KIMGUARD® sterilization
wrap. 8 For United States users: when sterilizing the device, use only sterilization wraps and sterilization trays that have been
cleared by the FDA to use with the selected sterilization cycle.
4.5 4.5.1
Instructions for Reprocessing Point of Use
•
Remove any adapters from the cable to optimize the cleaning and sterilization process.
•
Wipe excess soil from the device using disposable paper towels.
•
If an automated reprocessing method will be used, rinse any hard-to-reach areas in the device with 50 mL of sterile distilled water immediately after use.
4.5.2 •
Containment and Transportation
Reprocess the device as soon as reasonably practical following use. Note: Cleaning was validated with a 30 minute wait time.
•
Transport the device in a tray to avoid damage. Follow the facility’s internal procedures for the transportation of contaminated surgical instruments and devices.
4.5.3
Cleaning
4.5.3.1
Manual Cleaning
No te: For necessary materials and eq uipmen t, see t he Materia ls and Eq uipmen t table.
EN- 9
1.
2.
3.
4.
5.
6.
Soak •
Prepare an enzymatic detergent according to the manufacturer instructions.
•
Fully immerse the device in the detergent. Use a syringe to inject 50 mL of the detergent into any mated surfaces and crevices.
•
Soak the device in the detergent for 15 minutes.
Brush •
Thoroughly brush the exterior of the device with a soft-bristle brush for 90 seconds, focusing on any mated surfaces and crevices.
•
Use a syringe to inject 50 mL of the detergent into any mated surfaces and crevices 5 times.
Rinse •
Remove the device from the prepared detergent. Rinse the device with reverse osmosis/de-ionized (RO/DI) water at ambient temperature for 90 seconds or until all visible detergent residue is removed.
•
Flush any mated surfaces and crevices 5 times. After all visible detergent residue is removed, continue to rinse for 30 seconds.
•
Drain excess water from the device and dry it with a clean cloth or filtered pressurized air.
•
Visually inspect the device for cleanliness, paying close attention to hard-to-reach areas. If visible soil remains, repeat steps 1 through 3.
Soak •
Prepare a non-enzymatic detergent according to the manufacturer instructions.
•
Fully immerse the device in the detergent. Use a syringe to inject 50 mL of the detergent into any mated surfaces and crevices.
•
Soak the device in the detergent for 15 minutes.
Brush •
Thoroughly brush the exterior of the device with a soft-bristle brush for 90 seconds, focusing on any mated surfaces or crevices.
•
Use a syringe to inject 50 mL of the detergent into any mated surfaces and crevices 5 times.
Rinse •
Remove the device from the prepared detergent. Rinse the device with reverse osmosis/de-ionized (RO/DI) water at ambient temperature for 90 seconds or until all visible detergent residue is removed.
•
Flush any mated surfaces and crevices 5 times. After all visible detergent residue is removed, continue to rinse for 30 seconds.
•
Drain the excess water from the device and dry it with a clean cloth or filtered pressurized air.
•
Visually inspect the device for cleanliness, paying close attention to hard-to-reach areas. If visible soil remains, repeat steps 1 through 6.
4.5.3.2
EN- 10
Automated Cleaning
No te: For necessary materials and eq uipmen t, see t he Materia ls and Eq uipmen t table. 1.
2.
3.
Brush •
Prepare an enzymatic detergent according to the manufacturer instructions.
•
Fully immerse the device in the detergent. Thoroughly brush the exterior of the device with a soft-bristle brush for 90 seconds, focusing on any mated surfaces and crevices.
Rinse •
Rinse the device with reverse osmosis/de-ionized (RO/DI) water at ambient temperature for 90 seconds or until all visible detergent residue is removed.
•
After all visible detergent residue is removed, continue to rinse for 30 seconds.
Automated wash •
Place the device in the washer on an incline to facilitate drainage.
•
Program the washer using the following parameters: Phase
Recirculation Time
Temperature
Detergent Type
Pre Wash
2 minutes
Cold water
N/A
Enzyme Wash
2 minutes
Hot water
Enzymatic detergent
Wash 1
2 minutes
Set point 66 °C (151 °F)
Non-enzymatic detergent
Rinse 1
2 minutes
Hot water
N/A
Dry Phase
2 minutes
115 °C (239 °F)
N/A
•
Filtered pressurized air can be used to aid in drying.
•
Visually inspect the device for cleanliness, paying close attention to hard-to-reach areas. If visible soil remains, repeat steps 1 through 3.
4.5.4
Disinfection (optional) Warning
The device must be sterilized after disinfection. Failure to sterilize the device before reuse presents an acute infection control risk to the patient. No te: For necessary materials and eq uipmen t, see t he Materia ls and Eq uipmen t table.
4.5.4.1
Thermal Disinfection
The device can be disinfected using thermal disinfection. 1. Place the device into the washer disinfector.
EN- 11
2.
Program the washer using the following parameters: Thermal Disinfection Recirculation Time
1 minute
Water Temperature
90 °C (194 °F)
4.5.5
Sterilization
After performing the cleaning instructions specified above, perform one of the following sterilization cycles. No te: For necessary materials and eq uipmen t, see t he Materia ls and Eq uipmen t table. 4.5.5.1
Steam
N o t e f o r U n i t e d S t a t e s u s e r s : For all autoclave-compatible devices, Stryker recommends using steam sterilization instead of liquid chemical sterilization. 1.
Clean and prepare the device as recommended in this user manual.
2.
If using a sterilization tray, follow any additional instructions provided with the tray. Use only trays that are compatible with steam sterilization.
3.
Double wrap the device (or tray) prior to sterilization.
4.
Sterilize the device using the parameters below. Note: The water used in the autoclave process must meet standards for clean ste am per AAMI ST7 9 Annex M – Steam Quali ty. Gravity Wrapping
Double
Temperature
132 °C (270 °F)
134 °C (274 °F)
Sterilization Time
15 minutes
10 minutes
Dry Time 5.
30 minutes
Allow the cable to completely dry and cool to room temperature before reuse.
4.5.5.2
Steris/Amsco V-PRO
1.
Clean and prepare the device as recommended in this user manual.
2.
If using a sterilization tray, follow any additional instructions provided with the tray. Use only trays that are approved for sterilization with Steris/Amsco V-PRO.
3.
Double wrap the device (or tray) prior to sterilization.
4.
Sterilize the device using one of the following V-PRO sterilization systems: •
V-PRO 1 Sterilizer (Standard cycle)
•
V-PRO 1 Plus Sterilizer (Non-Lumen or Lumen cycle)
•
V-PRO maX Sterilizer (Non-Lumen or Lumen cycle)
EN- 12
5.
Allow the cable to cool to room temperature before reuse.
4.5.5.3
Steris System 1
Note: Steris System 1 is not intended for use in the United States.
W a r n i n g : Using another sterilization tray than specified below can result in incomplete sterilization. When placing the cable in the sterilization tray, do not coil the cable, and minimize the number of contact points where the cable sheath touches itself. Failure to observe this warning can result in incomplete sterilization. 1.
Clean and prepare the device as recommended in this user manual.
2.
Place the device in the Steris Flexible Processing Tray (model #C1140).
3.
Arrange the cable in the tray to allow for maximum sterilant exposure around all surfaces of the cable. Correct
Inco rrect
4.
Following the manufacturer instructions, sterilize the device using System 1 with Steris 20 Sterilant.
5.
Remove the device from the Steris chamber once sterilization is complete to prevent moisture from condensing inside the device.
6.
Allow the cable to completely dry and cool to room temperature before reuse.
4.5.5.4
Sterrad
1.
Clean and prepare the device as recommended in this user manual.
2.
If using a sterilization tray, follow any additional instructions provided with the tray. Use only trays that are approved for sterilization with Sterrad 100S, NX, or 100NX.
3.
Double wrap the device (or tray) prior to sterilization.
4.
Following the instructions of the manufacturer, sterilize the device using the Sterrad 100S, NX, or 100NX system. Select the standard cycle.
5.
Allow the cable to cool to room temperature before reuse.
4.5.5.5 1.
Ethylene Oxide (EO)
Clean and prepare the device as recommended in this user manual.
EN- 13
2.
If using a sterilization tray, follow any additional instructions provided with the tray. Use only trays that are compatible with EO.
3.
Double wrap the device (or tray) prior to sterilization.
4.
Sterilize the device using the parameters below. Pre condi tioning Temperature
55 °C (131 °F)
Chamber Humidity
70% RH
Vacuum Set Points
1.3 psia
Time
30 minutes
Exposure Concentration
725 mg/L, 100% EO
Temperature
55 ± 2 °C (131 ± 3 °F)
Time
1 hour
Chamber Humidity
70% RH (50–80%) ± 5%
Aeration
5.
Aeration Time
12 hours
Temperature
55 ± 2 °C (131 ± 3 °F)
Allow the cable to cool to room temperature before reuse.
EN- 14
5 Maintenance 5.1
Inspection
•
Inspect the device on a continual basis. If you observe or suspect a problem, return the device for evaluation and possible repair.
•
Inspect all components for cleanliness. If fluid or tissue buildup is present, repeat the above cleaning and sterilization procedures.
5.2
Storage
Store the device in a dry, clean, and dust-free environment at room temperatures.
5.3
Expected Service Life
The expected service life of the cable is 100 reprocessing cycles. Prior to each use, visually inspect the cable for damage and test the device function. If there is any sign of damage of malfunction, the device should not be used. When the device has reached the end of its service life, dispose of it according to local laws and hospital practices.
EN- 15
6 Symbol Definitions Symbols found on the device, on its packaging, and in this manual have specific meanings that clarify the proper use and storage of the device. The following list defines the symbols associated with this product.
Consult instructions for use Caution (consult instructions for use) Device is shipped non-sterile and must be sterilized before use Stryker European representative Federal law (USA) restricts this device to use by, or on order of, a physician
The device meets requirements for safety and effectiveness set forth in MDD 93/42/EEC
Date of manufacture
Legal manufacturer
Product catalog number Batch code Quantity
EN- 16
Produced for: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-800-624-4422 U.S. Patents: www.stryker.com/patents Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: t h e S t r y k e r L o g o , S a f e L i g h t . All other trademarks are trademarks of their respective owners or holders. 0233065077H 2015/12 DS03
2015/12