OLYMPUS

CLL-S1 Strobe Instructions for Use Nov 2014

Instructions for Use

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File Name: OLYMPUS - W709370 3-0 - CLL-S1 Strobe Instructions for Use Nov 2014 - 2014-11.pdf

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INSTRUCTIONS FOR USE OLYMPUS CLL-S1

WA97010A

Content 1

General Information...5 1.1 Intended Use...5 1.2 Upon Delivery...5 1.3 Manufacturer...6

Terminology...7 2.1 Symbols and Labels...10

Technical Data...12 3.1 Specifications...12 3.2 Power Cable...12 3.3 Ambient Conditions...13

Compatible Components...14

Before Use...15 5.1 Foot Holders...15 5.2 Connecting the Light Source...16 5.3 Testing the Light Source...20

Use...21 6.1 Light Modes...22 6.2 Stroboscopic Modes...22 6.3 Examination...23 6.4 After Use...24

Cleaning and Disinfecting...25 7.1 Manual Cleaning and Disinfection...25

Repair...27 8.1 Maintenance...27 8.2 Annual Inspection...27 8.3 Fuse Replacement...28 8.4 Storage...29

Troubleshooting...30

10 Electromagnetic Compatibility...32

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General Information

1.1 Intended Use Light source for the use with a compatible telescope for illumination purposes during diagnostic and therapeutic procedures. The light source is to be used in combination with products for: -- Rhinology -- Otology -- Laryngology -- Oral surgery -- Head and neck surgery Do not use for any other purpose. Specific intended use Otorhinolaryngology, especially laryngoscopic diagnostics. Procedures in medical offices and clinical environments. Medical use This light source is to be used only in a medical facility by trained medical personnel.

1.2 Upon Delivery Inspect immediately • Make sure that the shipping case contains the following items: -- Light source -- Foot switch -- Microphone -- Extension cable -- 2 BNC cables -- 4 foot holders -- Stencil for foot holders -- 2 spare fuses -- Instruction manual -- Olympus Endoscopy System Guide Contact an Olympus representative or an authorized service center if any items are missing or damaged. NOTE Instruction manual set The complete instruction manual set for this light source consists of this productspecific instruction manual, the instruction manual of the foot switch, and the system-related instruction manual, entitled “Olympus Endoscopy System Guide”. If either manual is missing, immediately contact an Olympus representative. Keep the instruction manual set in a safe, accessible location. W709370x

OLYMPUS CLL-S1

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

1.3 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany

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Terminology Light source, front

CLL-S1

LIGHT

STROBE

DUTY CYCLE

PERMANENT STROBOSCOPE

FIXED PHASE SLOW MOTION

HIGH LOW

FREQUENCY

BRIGHTNESS MIN

SOUND LEVEL

MAX

MIC

FOOT ON

1) Power switch 2) Power indicator 3) Socket for light-guide cable 4) Control panel

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Light source, control panel

LIGHT

STROBE

DUTY CYCLE

PERMANENT STROBOSCOPE

FIXED PHASE SLOW MOTION

HIGH LOW

FREQUENCY

BRIGHTNESS MIN

SOUND LEVEL

MAX

MIC

FOOT ON

5) PERMANENT light indicator 6) FIXED PHASE indicator 7) DUTY CYCLE indicators 8) Brightness display 9) STROBOSCOPE light indicator 10) Voice frequency display 11) LIGHT button 12) SLOW MOTION indicator 13) STROBE button 14) Sound level display 15) DUTY CYCLE button 16) Brightness control buttons 17) Microphone socket 18) Foot switch indicator

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Light source, rear panel

FOOT SWITCH

AUDIO OUT

VIDEO OUT

VIDEO IN

19) Ventilation slots 20) Foot switch socket 21) Audio output 22) Potential equalization conductor 23) Video output 24) Video input 25) Power supply 26) Fuse holder Foot switch Steute, type WF HS 0-5V/0-5V MED GP14

1) Pedal 2) Button 3) Coupling sleeve

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Microphone

1) Clip 2) Microphone connector Extension cable

1) Connector to microphone 2) Connector to light source

2.1 Symbols and Labels Potential equalization

CE certification mark – symbol for the compliance with the Medical Device Directive 93/42/EEC cTUVus marking

Symbol to indicate compliance with EMC requirements by the Japanese Ministry of Health, Labour, and Welfare Fuse Catalogue number

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Serial number Manufacturer

Type BF applied part

Follow instructions for use

Must not be disposed of as unsorted municipal waste

Caution, consult accompanying documents

Consult instructions for use (microphone and microphone extension cable)

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Technical Data

3.1 Specifications Dimensions Height...111 mm Width...370 mm Depth...475 mm Weight... 7.85 kg ±0.2 kg LED Operating hours of LED...2,000 hours Duty cycle High...15 % Low...10 % Mains connection Voltage... 100 to 240 V Frequency... 50/60 Hz Power consumption... 100 VA Fuse... T 3.15 AH 250 V Safety Protection class according to IEC 60601-1... BF Ingress protection rating... IPX0 Microphone Cable length...1 m Length of extension cable...1 m Type... electret condenser microphone Polar pattern...omnidirectional Frequency response... 100 to 12,000 Hz Sensitivity... -42 dB at 1 kHz (0 dB = 1 V/Pa) Output impedance... 2.2 kΩ Power supply... phantom power (1.5 to 10 V =) Output connector...3.5 mm (1/8”) mono TS connector Audio/Video AUDIO OUT...line-level audio output with Vpp < 1 V VIDEO IN and VIDEO OUT...75 Ω composite video signal

3.2 Power Cable Length WA95621A, WA95622A, WA95623A...4.5 m

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Plug type WA95621A...Type E/F (CEE 7/7) WA95622A...Type B (NEMA 5-15) WA95623A... Type G (BS 1363)

3.3 Ambient Conditions Operating conditions Ambient temperature... 10 to 38 °C (50 to 100 °F) Relative humidity...30 to 85 % Atmospheric pressure...700 to 1060 hPa Storage conditions Temperature... 10 to 40 °C (50 to 104 °F) Relative humidity...30 to 75 % Atmospheric pressure...500 to 1060 hPa Transport conditions Temperature...-29 to 70 °C (-20 to 158 °F) Relative humidity...10 to 95 % Atmospheric pressure...500 to 1060 hPa

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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. NOTE Some of the products listed in this chapter may not be available in all sales territories.

LF-V, ENF-V…

ENF-…, LF-…

WA03200A WA03210A WA03300A WA03310A

CLL-S1

LIGHT

STROBE

PERMANENT STROBOSCOPE

FIXED PHASE SLOW MOTION

FREQUENCY

DUTY CYCLE HIGH LOW

BRIGHTNESS MIN

SOUND LEVEL

MAX

MIC

FOOT ON

WA97010A

Storz Wolf

A3213

Wolf

A3214

Circon/ACMI

A3215

OLYMPUS CLL-S1

WA97013A

W709370x

Before Use WARNING Risk of damage This device must not be used in a flammable atmosphere. WARNING Risk of damage Other electrical devices can interfere with the function of the light source. Do not place the light source next to, on or under other electrical devices. If the light source must be placed next to, on or under other electrical devices, monitor the light source during the procedure to make sure that the light source does not switch off and that the brightness does not change. WARNING Risk of cardiac arrest If endoscopes are used with energized endoscopically-used accessories, the patient leakage currents may be additive. CAUTION Risk of damage Blocking the ventilation slots can cause overheating. Make sure that the ventilation slots are not blocked.

5.1 Foot Holders CAUTION Risk of damage Protect the light source against falls. Install the foot holders that are delivered with the light source as described below. Install the foot holders • Put the stencil on the surface where the light source will be set up. • Remove the protective foil from the foot holders. • Place the foot holders in the cut-outs of the stencil. The adhesive side must face down. • Remove the stencil. • Place the light source on the foot holders. Make sure that the feet of the light source fit into the foot holders. • Firmly press the light source into the foot holders.

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5.2 Connecting the Light Source WARNING Risk of electric shock According to IEC 60601-1 requirements, this light source is equipped with a potential equalization conductor. Ground the light source to ensure a safe use. WARNING Risk of patient injury and/or equipment damage Only connect original accessories (foot switch, microphone, microphone extension cable) to the light source. For replacement, contact your local Olympus representative. WARNING Risk of electric shock Use only medical grade audio and video equipment according to IEC 60601-1 requirements. CAUTION Risk of damage Do not switch on the light source or any other equipment before connecting all cables. The light source can be damaged. Electrical contacts • Check the electrical contacts of all equipment which will be used during the procedure. Mains connection • Connect the power cable to the light source. • Connect the other end of the power cable to the mains socket. NOTE Connect this unit only to a grounded alternating current mains supply that complies with the requirements of IEC 60320-1 / C13 and the input requirements indicated on the rating plate on the rear panel of the unit. The power cable must not be longer than 4.5 m.

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Connect the light-guide cable • Connect the light-guide cable to the endoscope.

• Connect the light source connector to the light source. The light source connector must click into position. • Test the light-guide cable. Refer to the instruction manual of the light-guide cable. Connect the microphone WARNING Risk of injury to the patient There is a risk of an electric shock that may result in a cardiac arrest. Be aware that the light source and the microphone are type BF applied parts. Even when connecting a light-guide cable, which is a type CF applied part, the whole system still only complies with the requirements of type BF. • Do not connect and use the microphone for procedures in which the endoscope touches the heart directly. CAUTION Risk of equipment damage Do not subject the microphone to excessive shock.

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• Connect the microphone to the light source. The microphone connector must click into position. • Test the microphone. • If the microphone does not work, check the connection. Connect the extension cable (optional) • Connect the extension cable to the light source. • Connect the microphone to the extension cable. Attach the microphone • Place the microphone in a position where it picks up the voice of the patient. Appropriate places can be: -- the examiner’s clothes -- the patient’s clothes -- a trolley or any other installation in the patient’s proximity Avoid direct skin contact! WARNING Risk of electric shock Serious effect on cardiac function Do not connect the microphone to any other socket than the microphone socket on the front plate of the light source. Connect the microphone to the microphone socket before attaching the microphone to the patient or the patient’s proximity. Avoid contact of the microphone to skin of the patient. The microphone must be used under the supervision of a trained physician. NOTE Risk of damaging the endoscope Do not attach the microphone to the endoscope.

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Connect the foot switch (optional)

• Connect the foot switch to the light source. WARNING Risk of an electrical malfunction of the foot switch Do not use the foot switch in an operating room. Test the foot switch • Press the button while the light source is in STROBOSCOPE mode. The STROBOSCOPE mode must now switch between SLOW MOTION and FIXED PHASE.

• Press the proximal part of the pedal to the end (indicated by an arrow in the figure above). The light mode will change from STROBOSCOPE mode to PERMANENT mode temporarily. This will be indicated by the PERMANENT light indicator. Connect a camera control unit and a monitor for video overlay To display the frequency measurement and the sound level measurement on a screen or recording device: • Connect the composite output of the camera control unit to the video input of the light source. • Connect the video output of the light source to the composite input of the monitor or recording device.

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NOTE When the video signal is routed through the light source, the signal is limited to Standard Definition Composite Video (PAL/NTSC). Video sources with alternative video standards cannot be connected to the light source. Connect a documentation system (optional) Refer to the instruction manual for the documentation system. NOTE Do not use data from the documentation system for diagnosis or evaluation purposes.

5.3 Testing the Light Source WARNING Risk of injury Light emission from the light-guide cable or endoscope can damage the retina. Make sure that the light-guide cable or endoscope does not point at the patient’s or user’s eye. Do not look directly into the light emission of the light source. NOTE The light source keeps the settings from the previous use. Functional test • Switch on the light source. All indicators and displays light up for a few seconds. The light output is activated. • Check the quality of the endoscopic image. Refer to the instruction manuals of the endoscope, the light-guide cable, the camera control unit and the monitor. • Check the displays of the light source. The displays for the voice frequency and the sound level must display values. When there is no signal, the displays for the voice frequency and the sound level show a dash (–). • Check the on-screen display of the monitor. The values for voice frequency and sound level are displayed in the upper right corner of the monitor. When there is no signal, no values are displayed on the monitor. Preparation • Attach the microphone to the patient. WARNING Spare equipment Always have spare equipment available in case of a malfunction.

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Use Before use Make sure that the light source has been properly inspected and tested. WARNING Risk of injury If light source shows any signs of malfunction or unexpected behavior during use, contact an Olympus representative or an authorized service center. Do not use the light source WARNING 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. Using the endoscope can have a serious effect on the cardiac function (e.g. ventricular fibrillation). Never let the endoscope or any of the instruments used in this procedure come into contact with the heart or any tissue near the heart. WARNING Injury and damage from thermal exposure Light sources emit large amounts of energy. As a result: -- The light-guide connector and the distal end of the endoscope become extremely hot. -- The light energy is concentrated in a relatively small area. Risks: -- Thermal injury to the patient tissue (e.g., from excessive exposure to the intense illumination in cavities with small lumens, or if the distal end of the endoscope is placed into close proximity with the tissue). -- Burns to the patient’s or user’s skin. -- Burns or thermal damage to surgical equipment (e.g., surgical drapes, plastic materials). Countermeasures: -- Avoid excessive exposure to intense illumination. -- Use the minimum level of illumination necessary to satisfactorily illuminate the target area. -- Do not place the light-guide connector or the distal end of the endoscope on the patient’s skin, on flammable materials or on heat-sensitive materials. -- Do not touch the light-guide connector or the distal end of the endoscope. -- Switch off the light source when disconnecting the light-guide cable from the endoscope. -- Allow the endoscope and the light- guide cable to cool down after use. WARNING Risk of injury Light emission from the light-guide cable or endoscope can damage the retina. Make sure that the light-guide cable or endoscope does not point at the patient’s or user’s eye. Do not look directly into the light emission of the light source.

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