EndoLED WA91500A and WA91502A Instructions for Use March 2013

Contents

General Information...5 Upon Delivery ...7 Manufacturer...9 Terminology ...11 Symbols and Labels ...13 Technical Data...17 Compatible Components ...21 Before Use...25 Inspection ...27 Connection to an Endoscope...27 Testing ...33 Use ...35 Procedure ...37 After Use...39 Reprocessing...45 Cleaning ...53 Sterilization ...55 Maintenance ...57 Replace Batteries ...57 End of Product Life ...65 Troubleshooting...67 Electromagnetic Compatibility...70

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General Information

Intended use. WA91500A, WA91502A

Light source for exclusive use with an endoscope for the illumination of the observed area in gynecology, urology, ENT and intubation for diagnostic and therapeutic purposes.

Do not use it for any other purpose.

Medical use. This product is to be used only in a medical facility by trained medical personnel.

NOTE! Instruction manual set. The complete instruction manual set for this product consists of this productspecific instruction manual (delivered together with this product) and the system-related instruction manual, entitled “Olympus Endoscopy System Guide” (supplied with Olympus telescopes). Immediately contact an Olympus representative if either manual is missing or lost. Keep the instruction manual set in a safe, accessible location.

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WARNING! Read all instruction manuals thoroughly. Before use, read this manual, the Olympus Endoscopy System Guide, and the manuals for all other equipment which will be used during the procedure. An insufficient understanding of the dangers, warnings, cautions, and information in these manuals can result in death, serious injury, or equipment damage.

Medical Device Directive (Europe). This product complies with the requirements of Directive 93/42/EEC concerning medical devices.

Upon Delivery

Inspect immediately. • Make sure that the shipping case contains all of the items listed below. • Contact your Olympus representative or an authorized service center if any items are missing or damaged.

Contents WA91500A. • Light source • 2 adapters O0332 • Instruction manual • Accessory sheet “EndoLED: Compatible Batteries”

2x

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Contents WA91502A. • Light source • Instruction manual • Accessory sheet “EndoLED: Compatible Batteries”

Unpacking. • Remove the product from the packaging. Do not use the packaging for routine storage.

Manufacturer

Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany

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Terminology

Light source WA91500A. 1) Socket (with light admission surface) 2) Release button 3) Distal part 4) Main body 5) Battery indicator 6) Power switch 7) Battery compartment lid 8) Buckle 9) Lever

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Light source WA91502A. 1) Socket (with light admission surface) 2) Distal part 3) Locking screw 4) Main body 5) Battery indicator 6) Power switch 7) Battery compartment lid 8) Buckle 9) Lever

Symbols and Labels

OI

Power switch

Refer to the accompanying instruction manual.

Power supply by battery

+ –

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Battery polarity

Must not be disposed of as unsorted municipal waste.

WARNING! Risk of injury to the patient and/or user (light-emitting diode (LED) radiation). • Use the light source only when connected to a compatible endoscope. • Do not point in the patient’s eye with the distal end of the endoscope or the light source’s socket. • Do not look directly into the distal end of the endoscope or the light source’s socket.

Type BF applied part

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Technical Data

Operating environment. Ambient Temperature ...10–30 °C ...50–95 °F Relative humidity ...30–85 % Air pressure ...700–1060 hPa

Dimensions. Weight (without batteries) WA91500A...125 g WA91502A...119 g Maximal dimensions (length x width x depth) WA91500A ...112 x 34 x 39 mm WA91502A ...90 x 70 x 35 mm Outer diameter (distal part) WA91500A...28 mm WA91502A...27 mm Inner diameter of socket WA91500A...9 mm WA91502A...5.5 mm LED. Color temperature ...5000–6350 K Wave length ...400–800 nm Laser class according to EN 60825-1:1994 + A1:2002 + A2: 2002 ...2M Power supply. Battery...2 x AA Input voltage of light source ..1.9–2.5 V See separate accessory sheet “EndoLED: Compatible Batteries”. Safety. Protection class according to IEC 60601-1:2005...BF Protection against foreign bodies and dripping water...IP47

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IP classification according to IEC/EN 60529:1991 + A1:2000 (degree of protection by enclosure). IP 47 No ingress of solid objects of ≥ 1.0 mm diameter. The equipment is suitable for temporary immersion in water.

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Compatible Components

WARNING! Risk of injury to the patient and/or user. Use only compatible equipment as listed in this section. If other combinations are used, the full responsibility is assumed by the user. Future products may also be compatible. For further details contact an Olympus representative.

CAUTION! Risk of damaging the instrument. • Only use the batteries listed in accessory sheet “EndoLED: Compatible Batteries”. The use of other batteries may damage the instrument during reprocessing.

NOTE! For flexible endoscopes, Olympus recommends light-guide adapters MAJ-900 and MAJ-1413. Use lightguide adapter MAJ-900 when possible. This light-guide adapter provides a better illumination of the endoscopic image.

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Before Use

WARNING! Infection control risk. Properly reprocess the product before first and each subsequent use following the instructions in this manual and in the Olympus Endoscopy System Guide. Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel.

WARNING! Risk of patient injury. Always have a spare light source available in order to replace the light source in case of a malfunction or when the batteries are not charged sufficiently.

WARNING! Risk of injury to the patient and/or user (light-emitting diode (LED) radiation). • Use the light source only when connected to a compatible endoscope. • Do not point in the patient’s eye with the distal end of the endoscope or the light source’s socket. • Do not look directly into the distal end of the endoscope or the light source’s socket.

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NOTE! When the light source is not used over an extended period: - Remove the batteries. - Before use, make sure that the batteries are loaded to full capacity. Refer to chapter “Troubleshooting”.

Inspection

Inspecting the product. Visually inspect the product. Make sure that: - The mechanical condition of the product does not impair safe use. - The text and labels are legible. - No safety-relevant contamination of the product exists.

Check sealing ring. • Check the sealing ring for damage. • Replace the sealing ring, if necessary.

Connection to an Endoscope

WARNING! Risk of injury to the patient and/or user. Do not switch on the light source before connecting the endoscope.

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Connect the light source WA91500A to a rigid telescope. • Select a compatible telescope. • Attach light-guide adapter O0332 tightly to the telescope’s light-guide connector. • Press and hold the light source’s release button. • Insert the telescope’s light-guide connector (with light-guide adapter) in the light source’s socket until it clicks into position.

Connect the light source WA91500A to a flexible endoscope. • Select a compatible endoscope. • Attach light-guide adapter MAJ-900 or MAJ-1413 tightly to the endoscope’s light-guide connector (see section “Compatible Components”). • Make sure that no additonal adapter is on light-guide adapter MAJ-900 or MAJ-1413. • Attach light-guide adapter O0332 tightly to the additional light-guide adapter. • Press and hold the light source’s release button. • Insert the endoscope’s light-guide connector (with light-guide adapter) in the light source’s socket until it clicks into position.

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Connect the light source WA91502A to the endoscope. • Select a compatible endoscope. • Align the black dot in the light source’s distal part with the red dot on the endoscope’s light-guide connector. • Slide the light source’s distal part onto the endoscope’s light-guide connector.

• Rotate the light source back and forth on the endoscope’s light-guide connector until it clicks into position.

• Secure the light source by turning the locking screw.

NOTE! Light source WA91502A can be rotated about 75° in both directions when it is connected to an endoscope.

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Testing

Check the endoscopic image. • Turn the light source on. • Check the quality of the endoscopic image according to each component’s instruction manual.

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Damaged product. If the product is damaged or does not function properly, do not use it. Contact an Olympus representative or an authorized service center.

Use

WARNING! Infection control risk. Do not open the battery compartment until the procedure has been completed. The light source will become unsterile. • Before use, sterilize the light source with inserted batteries. • Do not replace the batteries during the procedure. • Always have a spare light source available in order to replace the light source in case of malfunction.

Before use. Make sure that the product has been properly reprocessed, inspected, and tested.

BF

DANGER! Serious effect on cardiac function. The endoscope, the video equipment, and the light source are classified as type BF instruments according to IEC 60601-1. Therefore, never touch the endoscope, or any of the instruments used in this procedure, to the heart or an area near the heart. This can seriously affect the cardiac function of the patient (ventricular fibrillation, etc.).

Switching on. • Switch on the light source. The battery indicator glows green. The LED illuminates.

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NOTE! The light source can be switched on again immediately after use. No waiting time is required.

WARNING! Risk of eye injury to the patient and/ or user (light-emitting diode (LED) radiation). • Use the light source only when connected to a compatible endoscope. • Do not point towards the patient’s eye with the distal end of the endoscope or the light source’s socket. • Do not look directly into the distal end of the endoscope or the light source’s socket.

Procedure

Procedure. • Perform the procedure.

Battery indicator. The battery indicator displays information on the status of the light source’s batteries. When the light source has been switched on, the battery indicator displays one of the 3 following status: - Continuous green: The batteries are charged. - Continuous yellow: The batteries are almost completely discharged and must be replaced or recharged soon. - Flashing yellow: The batteries are discharged and must be replaced or recharged immediately.

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NOTE! When the batteries must be replaced, stop using the light source. • To replace or recharge the batteries, refer to section “Replace Batteries”.

CAUTION! Risk of damaging the instrument. • Only use the batteries listed in accessory sheet “EndoLED: Compatible Batteries”. The use of other batteries may damage the instrument during reprocessing.

After Use

Switching off. • Switch off the light source.

Detach the light source WA91500A from a rigid endoscope. • Press and hold the light source’s release button. • Remove the endoscope’s light-guide connector from the light source’s socket. • Remove the light-guide adapter(s) from the endoscope’s light-guide connector.

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Detach the light source WA91500A from a flexible endoscope. • Press and hold the light source’s release button. • Remove the light source and lightguide adapter O0332 from the endoscope. • Remove the light-guide adapter(s) from the endoscope’s light-guide connector.

Detach the light source WA91502A from the endoscope. • Loosen the locking screw.

• Remove the endoscope’s light-guide connector from the light source’s socket.

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