COMEC SOPRO 281 User manual

INTUITIVE
CONNECTION
User manual
Manuel d’utilisation
Manuale per utilizzatore
Manual de usuario
Betriebsanleitung
Gebruikershandboek
Instrucoes de funcionamento
Användarmanual
Instrukcja obsługi
Упутство за коришћење
ユーザーマニュアル

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User manual ___________________________________________ 5
Manuel d’utilisation ____________________________________ 29
Manuale per utilizzatore ________________________________ 53
Manual de usuario _____________________________________ 77
Betriebsanleitung _____________________________________ 101
Gebruikershandboek __________________________________ 125
Instrucoes de funcionamento ___________________________ 149
Användarmanual _____________________________________ 173
Instrukcja obsługi _____________________________________ 197
Korisničko uputstvo ___________________________________ 221
ユーザーマニュアル ___________________________________ 247

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INTUITIVE
CONNECTION
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INTUITIVE
CONNECTION
English
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ENGLISH

ENGLISH
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ENGLISH
766 7
Contents
1 Introduction _____________________________________ 9
2 Description of light source ________________________ 10
3 Safety instructions _______________________________ 11
4 Regulations _____________________________________ 13
5 Installation ______________________________________14
6 User settings ____________________________________ 15
7 Description _____________________________________ 16
8 Recommended decontamination procedure _________ 17
9 Customer service & maintenance __________________ 18
10 Technical characteristics __________________________ 20
11 Electromagnetic compatibility _____________________ 21
12 Symbols ________________________________________ 25

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We would like to thank you for the confidence you showed in us by purchasing this device.
Please read this manual carefully in order to fully benefit from the device while complying with
all necessary precautions.
Sentences marked with this symbol require particular attention.
Sentences marked with this symbol contain useful information.
In order to facilitate the installation and utilisation of this device we intended to make this
manual more practical. Therefore, throughout the manual you will find references to the
image page on the back of the cover (e.g. in form of D1 ) which will help you to identify the
corresponding parts of the product.
This user manual is an integral part of the appliance. It must be made available to the user.
Correct usage and proper handling of the appliance is made possible by following this manual.
The user bears the sole responsibility for damages that result from misuse.
1 Introduction

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This 30 Watt LED light source has been especially designed for endoscopic diagnosis
applications in medical practices of the following special fields: ent, gynecology, urology,
veterinary. It is equipped with an electronic iris with fibre optic sensor, an automatic thermal
protection system and a power level memory.
Its ease of use, its illuminating power and a precise manual light intensity regulation make it
an ideal medical device for multiple disciplines.
It comprises:
• the light source itself
• the power adapter (12V transformer) including a set of international plugs.
• the user manual
In order to ensure conformity of the product please only use the supplied transformer.
This equipment was supplied to you in a cardboard packaging, which you should keep for
potential transport.
Recommended accessories:
• Light cable: ø: 4.5mm; L: 2.5m (power supply connector: “Storz” only)
• Endoscopes with diameter: 1.9; 2.7; 3; 4; 8.5mm
We advise you to choose the light cable diameter in the following way:
Ø = 4.8mm for endoscopes of diameter > 4mm
Ø = 3.5mm for endoscopes of diameter <= 4mm
For the United States, Federal law restricts the sale of this product to physicians or under
their order.
2 Description
of light source

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3 Safety instructions
• Read the user manual carefully.
• The appliance should only be connected to a supply network with a grounding system.
• Observe the conditions of use and storage.
• Before connecting the light source to the mains supply, check if the parameters of your
power circuit match the specifications on the device. Information regarding the electric
voltage, the consumption etc. can be found on the power supply unit.
• Do not drop the appliance. If the appliance is dropped, do not reconnect it but return it to
your authorized distributor or directly to the aer-sales department.
• Never look directly in the light source or the end of the light cable.
• Do not submit the device to excessive dust exposure.
• The device should only be opened by a qualified technician authorized by the manufacturer.
• In the area of installation, the presence of high interference fields (strong magnetic fields for
example) should be avoided. These interference fields can result in malfunctions of the light
source
• This appliance may not be modified without authorization of the manufacturer. - If the
medical device is modified, an inspection and a test must be performed to ensure that the
medical device complies with the safety instructions.
• Do not insert any other objects than the light cable in the socket Bas otherwise damage
to the optical system may result.
• Do not insert metallic objects in the device as this may result in risk of electric shock, fire,
short circuit or hazardous emission.
• Do not expose the device to splash water or use in an environment with excessive humidity.
• Do only use the accessories supplied with the device or recommended by the manufacturer
as an option.
• The device is not explosion-proof. Therefore, never use it together with flammable
anaesthetics.
• Be sure to provide sucient air circulation to avoid overheating inside the appliance: at least
15 cm around the appliance. Do not cover the side and back air fans and ensure that the feet
of the device are there.
• Do not place heavy objects on the device.
• If the power cord or the transformer are damaged, immediately isolate the light source from
the electric circuit. It is extremely dangerous to operate the device with a defective power
cord.
• To disconnect the cable from the power supply always pull the plug, never the cable itself.
• Disconnect the device from the power supply, if you intend not to use it for several days or a
longer period.
• Do not place the light source on textile surfaces (carpet, blankets, etc.)
• This light source is exclusively intended for use with the endoscopes recommended in
chapter 2.
• Check the compatibility of your endoscope with the manufacturer before use.
• If other cables or accessories are used than the ones specified this may result in an increase
emissions or a decrease of the noise immunity of the device.
• The fans must not be covered D.

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• This appliance must be used on individuals (patients) suitable for undergoing a procedure of
endoscopy;
• The light source is intended for professional use in a consulting room / operating theatre.
• Ensure sucient ventilation in order to avoid overheating inside the device: at least 15cm
at all sides of the device. Do not cover the device and ensure that the feet of the device are
always visible.
• Never place the device near a heat source or in a location where it is exposed to vibration
and/or shock.
• A multisocket or extension cable must not be connected to the EM system.
• Never use corrosive or abrasive products to clean the device, but only the disinfectant
agents as recommended in chapter 8.
• This device is not suitable for use in an ionizing environment.
• Do not expose the device to laser radiation.
• The device is not sterile.
• Before every use, check the device for rough surfaces, sharp edges or protruding elements
which could present a safety risk.
• The surface temperature of the light cable ends can exceed 41°C (aer a few minutes of
use). Therefore, avoid holding area in contact with the patient.
• When removing the fibre from its light guide aer use of the lamp the temperature of the
metal coupler is very high and injuries may occur when touching.
• The luminous power at the outlet of the cable can cause damage to the eye. Be careful when
handling the light cable when the lamp is operating at full power.
• Aer use, be sure to remove the light cable carefully without touching the distal tip which
can be very hot and cause burns.
• Never touch the patient or other flammable material (bed sheets, dressings, surgical drapes)
directly with the end of the light cable or the endoscope as it can become very hot: risk of
burning.
• The devices that connect to the inputs/outputs must comply with IEC 60950-1
• Placed the light source in order to facilitate the disconnection of the power supply
• According to connection requirements the electro medical devices in contact with the body
of patient have to be compatible with endoscopies devices of type BF or CF
Class Laser : risk group 2
According to the standard IEC 62471. Do not look directly at the light to avoid any risk of eye
damage.
Caution : Possibly hazardous optical radiation emitted from this product. Do not stare at
operating lamp. may be harmful to the eyes.
Not suitable for use in the presence of inflammable anaesthetic gas mixture with air, oxygen or
nitrous oxide.
It is advisable to have a second light source available in the operating room to use if an
absence or degradation of performance is observed.
3 Safety instructions

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4 Regulations
This product was designed and manufactured by a company which has a certified quality
system in place. It complies with the requirements of EU directive 93/42/EEC on medical
products. It therefore also complies with the electrical safety standards (IEC) and the applicable
standards for electromagnetic compatibility (EMC).
4.1 Conformity
Despite compliance with the EMC standards, it may occur under certain circumstances that the
device interferes with other devices or is subjected to interferences by other devices and/or in an
electromagnetic environment.
In order to avoid such incidents we recommend the following:
• Ensure the quality of the electric supply (especially grounding of all devices and tables/trolleys)
• Keep the device away from electromagnetic sources (such as compressors, motors, transformers,
HF generators, etc...).
4.2 Electromagnetic interference and electrostatic discharge
Like all medical products this device is subject to the Medical Devices Vigilance regulations.
Therefore any serious malfunction must be immediately notified to the relevant authorities
and the manufacturer as detailed as possible.
For manufacturer contact details see last page of manual
4.3 Medical devices vigilance
This device is marked with the recycling symbol pursuant to EU directive 2002/96/EC on waste
electrical and electronic equipment (WEEE).
By correctly disposing of this device you avoid potential damage to the environment or human
health.
The symbol on the device or on the documents supplied means that the device must not
be treated as household waste. It must be deposited at a designated collection facility which is
dedicated to the recycling of waste electrical and electronic equipment.
In addition, all local regulations regarding disposal applicable in the country in which you work
must be observed.
For more information on treatment, recovery and recycling of the device please contact your
nearest distributor who will instruct you on the procedure to be followed.
4.4 Disposal

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5 Installation
The purpose of this device is the lighting of the work area through an endoscope.
An LED is supplied with current according to the intensity setting. This LED emits light which is
focused toward the exit of the optical fibre. The optical fibre transmits light towards the
endoscope to light the working area.
This medical device is intended to be used by a qualified surgeon during endoscopic
explorations. Its installation requires no special training. Please refer to the instructions in this
manual.
Place the device on a stable surface and connect the dierent accessories which are required
for operation.
If using a cabinet ensure sucient ventilation at all sides (min. 15 cm around the device).
• Select the suitable connector at the power adapter.
Only use the wall-mounted transformer supplied: FRIWO type FW 8030M/12.
• Connect the power cable to the light source A.
• Connect the power adapter to the mains supply.
Placed the light source in order to facilitate the disconnection of the power supply
5.1 Power supply connection
Do not attempt to unscrew or pull the round connector at the front of the device.
• As a standard, the light source is equipped with a fixed adapter for the «Storz» type light
cable which cannot be replaced.
• Insert the cable in the intended opening B, you should hear a clicking noise indicating
that the cable is locked.
• Connect the other end of the light cable to your endoscope.
Before connecting an endoscope (or a fiberscope) check the condition of the endoscope
(clean, distal lens, quality of optical fibres, adjust if necessary).
5.2 Connection of light cable

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6 User settings
The LED source is equipped with a switch at the top of the device C. Aer switching on the
device an automatic test of 3 seconds is performed to check all components. Then the lamp
switches in standby mode and the indicator light Lflashes yellow.
6.1 Switching on
To switch the LED in standby mode (light and fans o) simply press button Cfor a short
time. If pressed again the light will come back with the same luminous power as before stand
by mode ( except in case of power cut).
6.3 Power level memory
When switched on the device is started at its maximum power.
> Connect a light cable (to have luminous power).
> Press the button C, the luminous power is set to the maximum (continuous blue light).
> By pressing button Cfor a longer period the luminous power is decreased (flashing
blue) to reach the low intensity level (continuous green light), release.
> From the low intensity level, a long pressure on Cwill increase the luminous power
(flashing green) until you reach the maximum power ( continuous blue light), release.
> Select then the required luminous power, the LED may flash green or blue which
indicates that a long pressure will respectively increase or decrease the luminous power.
6.2 Adjusting the light intensity

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7 Description
• The fans must not be covered in order to prevent overheating.
• The light source is equipped with an automatic safety device which stops the light intensity
in case of excessive internal temperature.
7.1 Description of fans
The power supply of the device is realised by means of a mains transformer supplied with the
system.
7.2 Mains transformer plug
The specifications and symbols at the bottom of the product allow identification of the led
light source complying with the international standards IEC 60601-1, IEC 60601-2-18, IEC
60417 and EN 980 (see annex 1).
7.3 Specifications and symbols on the product

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8 Recommended
decontamination
procedures
This procedure applies exclusively to the enclosure of the LED light source.
The LED light source is a medical product which is not heat resistant and must not be
immersed in liquid. Consequently, disinfection is made using a non-woven fabric cloth to
which a disinfecting agent is applied.
The disinfecting agent can be chosen from the category F in the list of admitted
disinfectants by the French Society of Hospital Hygiene.
The cleaning depends on the selected products, methods and/or tools and is thus the sole
responsibility of the involved personnel.
The disinfection procedures indicated for this type of material indicate that disinfection is
made with these solutions for the entire life cycle of the product.
The device is not autoclavable.
Alkaline solutions available for disinfection of certain medical products are NOT allowed
for disinfection of this device.
The procedures described in this chapter are to be understood as guidelines only and can
in no event replace ocial recommendations or directives.
To ensure hygiene between patients and non-contamination, the light cable must be
changed from one patient to another following the rules of endoscopic practice (accessory not
supplied which must always be sterilized before each use).

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9 Customer service
& maintenance
No particular maintenance operation is needed for this appliance.
Make sure that the fans Dare not obstructed by dust. If this is the case, isolate the device
from the mains supply and vacuum the dust.
In case of incidents please contact our customer service or our nearest distributor.
We remind you that faults due to incorrect use are not covered by the guarantee.
Check if the mains transformer is connected properly to the mains supply.
9.1 The indicator light Ldoes not go on aer the device
has been switched on
Check if the requirements of chapter 6 “User settings”, are met.
Check the condition of the light cable and your optical system.
9.2 The light goes on but the luminous power is poor
Check if the light intensity is set too high.
Check the camera settings.
9.3 The delivered images are too bright or saturated
• The light cable is disconnected.
• The light source has an integrated safety device which automatically switches o the light in
case of excessive internal temperature of the device. Aer the temperature decreased, the
lamp can be used again:
- Ensure that there is sucient space around the device for adequate cooling
(minimum 15cm at all sides of the device).
- Ensure that the ventilation slots at the rear and the bottom of the source are not
covered.
If the fault persists and you need to return the device to customer service please return the
device in its original packaging aer disinfecting it.
The product must be disinfected before returning it for repair.
When returning a product check its condition and inform the carrier of any comments to be
recorded on the delivery note by registered letter within 48 hours. If goods shipped by us
are damaged during transport the repair amount will be either charged to the carrier, if the
comments were made in a timely manner, or otherwise they will be charged to the receiver.
9.4 There is no light but the fans continue to operate

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9 Customer service & maintenance
Check if the light cable has been connected correctly.
9.5 The light alternately switches on and o
The light source is in temperature protection mode, check if the temperature range specified
in the present manual is observed.
9.6 The indicator light illuminates cyan

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10 Technical
specifications
Main functions:
• LED technology
• Power rating: 30W – the light intensity corresponds to a 100 watt Xenon lamp
• Colour temperature: > 4500°K
• Typical LED life span: 50,000 hours (under normal conditions of use).
• Compatible light cable: “Storz” only
• Electronic aperture
• Adjustment of light intensity: manual
• Anti blinding system with light cable sensor
• Automatic overheat protection system
• Power level memory
• Supply voltage of the transformer: 100-240VAC / 50 - 60Hz
• Transformer: 12VDC
• Power consumption: 30VA
• Dimensions: L: 180mm; D: 95mm; H: 35mm
• Weight: 320g
• Continuous service
Environment:
• Operating temperature +10°C / +40°C
• Operating humidity: 30% to 75 %
• Transport and storage temperature: -10°C / +45°C
• Humidity during transport and storage: 20 to 85%
• Atmospheric pressure during operation, transport and storage: 700hPa to 1,060hPa
• Not splash-proof (IPXO)
• Not suitable for use with mixtures of flammable anaesthetics with air and oxygen or nitrous
oxide
Regulatiory:
• Electrical safety class 2, type BF
• Compliant with EU directive 93/42/EEC – class 1
• Compliant with international standards IEC 60601-1; IEC 601-2-18; IEC 60417 and EN 980
• Class Laser: risk group 2