LH-150PC Owners Manual Dec 2002

IMPORTANT Intended Use This electro-medical device (light source) is intended to be used as a source of illumination for endoscopes. Together, this light source and endoscope may provide optical visualization of, and/or therapeutic access to, various body cavities, organs and canals. Do not use this device for any purpose other than that for which it has been designed. This device should only be used by physicians who have thoroughly studied all the characteristics of this device and who are familiar with the proper techniques of endoscopy.

Important Read this manual before operating and save this book for future reference. This manual describes the recommended procedures for inspecting and preparing the Halogen Light Source prior to its use and the care and maintenance after its use. It does not describe how an actual procedure is to be performed, nor does it attempt to teach the beginner the proper technique or any medical aspects regarding the use of the equipment. Failure to follow the instructions in this manual may result in damage to and/or malfunction of the equipment. If you have any questions regarding any of the information in this manual or concerns pertaining to the safety and/or use of this equipment, please contact your local PENTAX representative.

Conventions Throughout this manual, the following conventions will be used to indicate a potentially hazardous situation which, if not avoided; :

could result in death or serious injury.

CAUTION:

:

may result in minor or moderate injury or property-damage.

NOTE:

:

may result in property-damage. Also, advises owner/operator about important information on the use of this equipment.

WARNING

FOR USA PRESCRIPTION STATEMENT: Federal (USA) law restricts this device to sale by or on the order of a physician or other appropriately licensed medical professional.

TABLE OF CONTENTS 1.

SAFETY PRECAUTIONS...

2

2.

NOMENCLATURE AND FUNCTION...

5

3.

PREPARATION AND SAFETY CHECK... 3-1. PREPARATION... 3-2. PRE-USE INSPECTION...

6 6 8

4.

OPERATION...

9

5.

MAINTENANCE... 10 5-1. AFTER EACH PROCEDURE... 10 5-2. WATER BOTTLE CLEANING... 10 5-3. CHANGING THE LAMP... 13 5-4. CHANGING THE FUSE... 14

6.

SPECIFICATIONS... 15

1. SAFETY PRECAUTIONS SAFETY PRECAUTIONS-IMPORTANT The following precautions should always be exercised with the use of all electro-medical equipment to ensure safety to all involved parties - user(s), patient(s), etc. Please read carefully and follow this owner’s manual.

1-1. TRAINING 1) This equipment should only be used under the supervision of a trained physician in a medical facility. Do not use in other locations or for any purposes other than the intended application.

1-2. INSTALLATION 1) This equipment should NEVER be installed or used in areas where the unit could get wet or be exposed to any environmental conditions such as high temperature, humidity, direct sunlight, dust, salt, etc., which could adversely affect the equipment. 2) This equipment should NEVER be installed or used in the presence of flammable or explosive gases or chemicals. 3) This equipment should NEVER be installed, used or transported in an inclined position nor should it be subjected to impact or vibration. 4) For safety reasons, this equipment must be properly grounded. This equipment should be connected to a three (3) prong hospital grade receptacle in U.S.A. or Canada. 5) Ensure that all power requirements are met and conform to those specified on the rating plate located on the rear panel. 6) Do not block the air intake vent of this equipment. 7) Do not allow the power cord to become twisted, crushed or pulled taut. 8) When using an isolation transformer for any ancillary equipment, ensure the power requirements of the devices do not exceed the capacity of the isolation transformer. For further information, contact your local PENTAX distributor.

1-3. PRIOR TO USE 1) Confirm that this equipment functions properly and check the operation of all switches, indicators, etc. 2) To prevent electrical shock when used with endoscopes, this equipment is insulated type BF electromedical equipment. Do not allow it to be grounded to other electrical devices being used on the patient. Rubber gloves should always be worn to prevent grounding through user(s). 3) Confirm that other devices used in conjunction with this equipment function properly and that these other devices will not adversely affect the operation or safety of this equipment. If any component of the endoscopic system is not properly functioning, the procedure should not be performed. 4) Check and confirm that all cords or cables are connected correctly and securely.

1-4. DURING USE 1) To prevent electric shock, the endoscope and/or any other ancillary device should NEVER be applied directly to the heart. 2) Make sure that no contact is made between the patient and this equipment. 3) The light emitted by the halogen lamp is extremely intense. Avoid looking directly at the light exiting the endoscope and/or this equipment. 4) To protect the users eyes and avoid risk of thermal injury during an endoscopic examination, use only the minimum amount of brightness required. 5) During clinical procedures, avoid unnecessary prolonged use which could compromise patient/user safety. 6) Continually monitor this equipment and the patient for any signs of irregularities.

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7) In the event that some type of irregularity is noted to the patient or this equipment, take the appropriate action to ensure patient safety. 8) If the operation of any of the components of the endoscopic system fails during the procedure and the visualization of the procedure is lost or compromised, place the endoscope in the neutral position and slowly withdraw the endoscope. 9) This equipment should only be used according to the instruction and operating conditions described in this manual. Failure to do so could result in compromised safety, equipment malfunction or instrument damage.

1-5. AFTER USE 1) Refer to the operating instructions supplied with all the components of the endoscopic system to establish the right order which component should be turned off in due course. Some peripheral devices may have to be turned off first to avoid compromising their operation. 2) Wipe all surfaces clean with gauze slightly dampened with alcohol. 3) Be sure connector interfaces and ventilation ports are not allowed to become wet or splashed with liquids.

1-6. STORAGE 1) This equipment should NEVER be stored in areas where the unit could get wet or be exposed to any environmental conditions such as high temperature, humidity, direct sunlight, dust, salt, etc., which could adversely affect the equipment. 2) This equipment should NEVER be stored in the presence of flammable or explosive gases or chemicals. 3) This equipment should NEVER be stored or transported in an inclined position, nor should it be subjected to impact or vibration. 4) Cords, accessories, etc., should be cleaned and neatly stored. 5) This equipment should be maintained in a clean condition during storage and be ready for subsequent use.

1-7. SERVICE 1) Alterations/modifications to the equipment should NEVER be made. 2) When replacing fuses, lamps, etc., use only the components recommended by PENTAX.

1-8. MAINTENANCE 1) Periodically this equipment and any applicable accessories should be inspected for operation and safety.

1-9. DISPOSAL This product is a medical device. In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed off as unsorted waste, but should be collected separately. Contact your local PENTAX distributor for correct disposal and recycling. By disposing of this product correctly you will help ensure that the waste undergoes the necessary treatment, recovery and recycling and thus prevent potential negative effects on the environment and human health which could otherwise arise due to inappropirate waste handling.

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POWER REQUIREMENTS Check the standard power plug configurations that are used in your country. If the appropriate power cord is not included in your product, notify your local PENTAX distributor.

Continental Europe (Use a SEV approved power plug for use in Switzerland)

U.K.

Australia and New Zealand

U.S.A. and Cananda (Hospital Grade)

SYMBOLS ON MARKING Alternating current Type BF Applied Part (Safety degree specified by IEC 60601-1) OFF (Power: disconnection from mains) ON (Power: connection to the mains) Attention, consult owner’s manual Dangerous voltage Protective earth (ground) can be hot and should not be touched without taking care. |

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China

2. NOMENCLATURE AND FUNCTION AIR/WATER CONNECTOR Inserts into Air/Water socket of endoscope umbilical cable(light guide plug)

AIR/WATER-DRAIN LEVER AIR OUTLET

A/W DRAIN

BRIGHTNESS CONTROL KNOB Brightness of observing field can be adjusted.

“DRAIN” will purge (drain) water in the water lines by allowing air flow only. “A/W” (= Air/Water) allows air and water feeding during procedure controlled by a Air/ Water valve on scope head.

WATER BOTTLE Should be 2/3 full with sterile water.

SCOPE LIGHT GUIDE SOCKET

LAMP HOUSING COVER Using a flat blade screw driver, open the cover to expose lamp housing for lamp replacement. Note: Following lamp replacement, properly position and fully secure the Lamp Housing Cover

AIR PUMP SWITCH Power switch must be on to activate Air Pump.

POWER SWITCH Activates main power.

A/W FUSE HOLDER DRAIN

SE

FU SE FU

SH PU

SH PU

POWER CORD PLUG USA Model: POWER CORD RECEPTACLE

To ensure adequate gounding plug into Hospital Grade receptacle.

Europe model: Different type according to each (shown) country's specifications with grounding provision. Voltage requirement is shown on the rear panel.

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3. PREPARATION AND SAFETY CHECK 3-1. PREPARATION 3-1-1 SETTING UP THE LIGHT SOURCE 1) Place the light source on a stable, level surface.

WARNING: – Avoid places where the light source may be splashed with liquid. – Absolutely DO NOT use in any environment with explosive or flammable gases or chemicals. – Do not block the ventilation grids on the sides of the light source. – Do not install, operate or store electro-medical equipment in a dusty environment. Accumulation of dust within these units may cause malfunction, smoke, or ignition.

2) Make sure the power switch is OFF. 3) Plug the power cord into an appropriate power source using the plug supplied with the unit.

CAUTION: When using any ancillary equipment such as a TV monitor, connect power cords of the ancillary equipment to isolation transformers to prevent electric shock.

NOTE: When using isolation transformers, be sure to check that the total power consumption of all the force devices does not exceed the isolation transformers’ power rating. Make sure that the power cord is connected to the main with an appropriate plug. Contact your local PENTAX distributor for the details.

3-1-2 CONNECTING THE WATER BOTTLE 1) Fill the water bottle approx. 2/3 full with sterile water. 2) Screw the water bottle cap assembly to the water bottle snugly.

A/W

.

DRAIN

NOTE: Do not overtighten the water bottle cap.

3) Set the Air/Water-Drain lever to A/Wposition. 4) Insert the water bottle air pipe stem into the LH-150PC water bottle receptacle and press until the water bottle 'clicks' into position.

NOTE: Do not press the water bottle too forcefully into the LH-150PC. Rough handling may cause water to leak onto/into the light source.

5) Insert the Air/Water connector into the holding on the water bottle cap assembly until the endoscope is connected.

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NOTE: Always disconnect the water bottle before moving the light source into a position not common to normal use. Always disconnect the water bottle before packing the LH-150PC for shipment.

3-1-3 CONNECTING THE ENDOSCOPE 1) Check to ensure the appropriate light guide adapter is mounted to the light source. 1. When using a PENTAX scope • Connect the adapter (OL-H3) to the scope light guide socket. • All PENTAX endoscope with either single or split light guide plug can be connected to this adapter (OL-H3).

NOTE: OL-H3 is already installed when delivered from the factory.

2. When using another manufacturer’s flexible or rigid scope • Replace the OL-H3 with the adapters below to the scope light guide socket. If the adapter has a pin for mounting, align the pin with the hole on the socket of the light source. • Other manufactures' flexible and rigid scopes can be connected to the adapters below. • Refer to the list of the adapters below and contact your local PENTAX distributor for the detail. ENDOSCOPE / LIGHT CABLE

ADAPTERS

Olympus (OES)

AL-OF5

Olympus (Pre-OES)

AL-OF1

Olympus (Rigid Style)*

AL-OR1

ACMI, STRYKER, V. MUELLER etc.

AL-AF1

Storz

AL-SF1

Machida

AL-MF1

NOTE: Attempting to connect a fiberscope without a light guide adapter and/or an appropriate light guide sleeve in place will damage the fiberscope and the light source.

2) Connect the scope slowly. 3) Press the scope firmly until 'clicks' into position. 4) When using a PENTAX scope, connect the water bottle Air/Water connector to the Air/Water receptacle on the endoscope umbilical connector (light guide plug). 5) Connect the suction tube of the suction device to the suction nipple on the umbilical connector of the endoscope.

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3-2. PRE-USE INSPECTION WARNING: Before every use, the following points should be checked. If any function or device in the endoscopic system does not perform properly, do not perform the endoscopic examination. Contact the manufacturer of the device, your PENTAX sales representative or a PENTAX service center before using the equipment for an endoscopic examination.

1) Ensure that the power cord is firmly plugged into a properly grounded receptacle.

CAUTION: Don't stretch the cord tight to prevent the plug from coming off.

2) Ensure that an endoscope is connected to the appropriate light guide socket properly. 3) Turn the power switch ON by depressing the power switch labeled (I). 4) Confirm that light is seen at the distal end of scope.

NOTE: If the power is not turned ON, replace the fuse on the rear panel. If the lamp fails to light, replace the lamp.

CAUTION: As a precaution, always have an extra (spare) lamp available as a standby lamp.

Air Feeding

Water Feeding

5) Depress the air pump switch. 6) Exercise Air/Water delivery through the endoscope. Covering air venting hole on top of Air/Water button lightly should deliver air at the distal end of the endoscope. By submerging the distal end in enough water to cover the tip, air flow will be demonstrated by a trail of bubbles. Pressing the button all the way down should deliver water through the tip of the endoscope. Use sterile water only. If all items above appear to function satisfactorily, then the endoscopic procedure may be performed. If any functionality above is compromised, DO NOT attempt to perform the endoscopic procedure. 7) Turn the brightness control knob clockwise to increase the brightness level or counterclockwise to decrease the brightness level.

WARNING: Avoid looking directly at the light exiting the endoscope or the light source.

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4. OPERATION It is important that all features of this device should be understood prior to clinical use. Refer to the operating instructions supplied with all the components of the endoscope system such as endoscope, photographic equipment, etc. 1) 2) 3) 4)

Do not block the air intake vent while the light source is being used. Be aware of the safety aspects of all other electrical equipment used in conjunction with this light source. It is recommended to use the endoscope system in a dark room to observe clearly. Select appropriate brightness level with the brightness control knob.

CAUTION: To avoid thermal injury and to protect the user's eye from high intensity light, it is recommended to select the brightness level as low as possible.

5) Air pump should be turned ON to deliver air/water through endoscope. 6) Use only sterile water during the endoscopic procedure.

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5. MAINTENANCE 5-1. AFTER EACH PROCEDURE 1) Turn the power switch OFF (0). 2) Unplug the power cord from the power cord receptacle. 3) Disconnect the endoscope and water bottle.

WARNING: Immediately after use, the metal light guide prong of the endoscope may be hot. To avoid burns, do not touch these areas immediately after use.

4) Wipe all surfaces with gauze slightly dampened with alcohol.

NOTE: Never allow liquids to be splashed on the light source. Be sure connector interfaces and ventilation ports are not allowed to become wet.

5-2. WATER BOTTLE CLEANING NOTE: Take care in handling the water bottle. DO NOT carry the water bottle by Air/Water connector or Air/ Water hose. When the cap assembly has been separated from the bottle, be careful in handling the water feeding stem.

The water bottle should be cleaned and sterilized on at least a daily basis. The water bottle assembly must be thoroughly cleaned. Failure to do so could result in incomplete or ineffective sterilization. 5-2-1 CLEANING 1) After use, the entire water bottle assembly (bottle, cap assembly and tubing) should be washed with clean running water and dampened gauze or scrub brush. An enzymatic detergent should be used for soiled items. 2) Ultrasonic cleaning of entire water bottle assembly is recommended to access difficult to reach areas. Use an operating frequency of 44 kHz ±6% or higher for a period 5 minutes. 3) After washing with the enzymatic solution, all surface of the water bottle assembly should be thoroughly rinsed and dried. Use gauze or cloth to wipe dry moist surfaces. Compressed air and 70 % alcohol should be used to facilitate drying of hard to reach areas.

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5-2-2 STERILIZATION Before any sterilizing the water bottle assembly, ensure the cleaning process above has been completed. (A) STEAM STERILIZATION

NOTE: LH-150PC standard water bottle assembly is model OS-H2 and is steam autoclavable. DO NOT confuse the OS-H2 steam autoclavable water bottle with its non-autoclavable predecessor. The OS-H2 water bottle assembly can be easily identified by the black Air/Water hose, off-white colored plastic cap (not transparent) and clear plastic bottle.

1) The OS-H2 water bottle assembly has been designed to withstand high pressure steam sterilization procedures. Use the parameters below: Sterilizer Type: Prevacuum

Temperature: 132 - 135 °C (270 - 275 °F)

Time: 5 minutes

2) During steam sterilization, ensure the cap assembly has been removed from the bottle. Make sure that the drain lever on the water bottle cap has been set to the A/W position (upright).

CAUTION: Use only the type of packaging material and package configuration as recommended by the manufacturer of the sterilizer. Use appropriate heat process indicators and/or biological monitors as recommended by the manufacturer of the sterilizer.

NOTE: These sterilization parameters are only valid with sterilization equipment that is properly maintained and calibrated.

(B) ETO STERILIZATION 1) Ethylene Oxide (ETO) gas sterilization can be performed on PENTAX water bottles, provided they have first been properly cleaned and thoroughly dried.

WARNING: Failure to thoroughly dry all surface areas could result in incomplete or ineffective sterilization. Moisture could prevent contact of the ETO gas with the actual contaminated surfaces.

2) The parameters below are proposed for ETO sterilization. 20:80 ETO/CO2

10:90 ETO/HCFC

Temperature:

55 ºC

55 ºC

Relative Humidity:

50%

50%

Vacuum:

533mm Hg Actual

533mm Hg Actual

Pressure (Start):

69 kPa (0,70 kg/cm2

EO Concentration:

450 mg/l

600 mg/l

Pre-Conditioning:

1 Hour

1 Hour

Gas Exposure Time:

5 Hours

5 Hours

Aeration:

12 Hours at 55 ºC

12 Hours at 55 ºC

, 10 PSI)

97 kPa (0,98 kg/cm2, 14 PSI)

3) Following ETO sterilization, aeration time of 72 hours is required. An aeration chamber may be used to shorten the aeration time to 12 hours but the temperature must not exceed 55 °C (131 °F).

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5-2-3 CARE DURING STORAGE Prior to storage, it is important to ensure that no residual water is left inside the water bottle assembly. Thoroughly dry all surface to reduce the potential for bacteria colonization during storage. Compressed air and 70% alcohol should be used to facilitate drying, if sterile water was not previously used to rinse the entire water bottle assembly.

CAUTION: To avoid disconnection and/or bursting of the internal tubing, always set the lever to the Air/Water position (upright) and use less than 165kPa (1,69kg/cm , 24PSI) air pressure during forced air drying.

Do not store the unit in direct sunlight or where temperature and humidity are high or where it can be exposed to liquids. For long term storage, take precautions to reduce dust build up within the light source.

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5-3. CHANGING THE LAMP Should the lamp burn out, a new Halogen Lamp (OL-H4) supplied by PENTAX can easily be replaced in the following manner:

WARNING: Before proceeding, allow adequate time for the lamp to cool down. If the light source was used beforehand, the lamp may still be HOT.

CAUTION: Be careful to avoid getting fingerprints on the lamp bulb or the reflector.

lamp holder lamp base

ledge lamp lever

ledge

1) Turn off the main power by depressing the power switch and disconnect the plug from the electrical outlet. 2) Using a flat brade screw driver, open the lamp housing cover to expose the lamp, lamp base, and lamp socket. 3) Move the lamp lever left to exposure the lamp base. 4) Pull out the lamp base from the lamp holder. 5) Pull out the lamp base from the lamp socket. 6) Replace the lamp base with a new lamp base and connect the lamp base to the lamp socket. 7) Push the lamp base into the lamp holder.

CAUTION: Ensure the position of the ledge to set the lamp correctly as shown left.

lamp base lamp socket

8) Using a flat brade screw driver, close the lamp housing cover.

NOTE: Should the unit appear to fail to operate following lamp replacement, check to ensure that the lamp housing cover has been properly repositioned and fully secured.

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5-4. CHANGING THE FUSE

CAUTION: Disconnect power cord before any examinations.

NOTE: Changing the fuse will require a flat blade screw driver.

1) 2) 3) 4) 5)

Using the screw driver, remove the fuse holder. Pull the fuse holder out by hand. Inspect the fuse, remove and replace the fuse if blown. Reinstall the fuse holder by turning clockwise with the driver. The voltage should always be indicated on the fuse.

WARNING: ALWAYS replace the fuse with the fuse value indicated on the rating plate on the rear panel. NEVER bypass the fuse. If the supplied spare fuse is not available, contact your local PENTAX service center.

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6. SPECIFICATIONS Specifications are subject to change without notice and without any obligation on the part of the manufacturer Item

Power requirement

Operating environment

Storage environment

Illumination

Scope compatibility

Specification

Observation

Voltage

120 VAC

Power consumption

200 VA

Voltage fluctuation

±10%

Frequency

50/60 Hz

Ambient temperature

10 – 40 ºC

Relative humidity

30 – 85%

Air pressure

700 – 1060 hPa

Ambient temperature

-20 – 60 ºC

Relative humidity

0 – 85%

Air pressure

700 – 1060 hPa

Lamp

EFR 15 V 150 W Halogen

Lamp's average life span

50 hours, continuous use

PENTAX endoscope

All models of fiberscopes

Other manufacturer's fiberscope

All models with use of appropriate adapters

Brightness Control

Water feed system

Cooling Classification as electro medical equipment

Safely & Hazardous prevention as Electromedical Equipment

Compliance Size

240 VAC

Manual adjustment Air pump system

Air feed system

230 VAC

Electro-magnetic vibrator system

Pressure

*

41 kPa – 62 kPa (0,63 kg/cm ) at flow rate of 0

Standard air feed volume

*

3,2 – 8,0 l/min at inlet of water bottle

Water compression

Pressurized by pumped air

Water bottle capacity

250 ml

Water in normal use

≤ 2/3 full, sterile water

Forced air cooling Type of protection electric shock

Class 1 equipment

Degree of protection against electric shock

BF type using insulated scope Application to the heart directly should not be attempted.

To prevent electric shock, connect power cords of ancillary equipment to isolation transformers. When using isolation transformers, be sure to check that the total power consumption of all the devices does not exceed the isolation transformers' power rating. Make sure that the power cord is connected the main with an appropriate plug. Designed in accordance

IEC 60601-1, IEC 60601-2-18

Degree of explosion proofing

Use in potentially flammable surroundings is prohibited

Dimensions (W×H×D)

Weight * Subject to fluctuation.

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*

W135×H165×D270 mm

*

6 kg

MEMO

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FOR EUROPEAN COUNTRIES DECLARATION OF CONFORMITY We, PENTAX Corporation 2-36-9, Maeno-cho, Itabashi-ku, 174-8639 Tokyo, Japan declare under our sole responsibility, that the product: Product Name

:

Model Number (S) :

HALOGEN LIGHT SOURCE LH-150PC

conforms to: the applicable provisions of the Medical Devices Directive 93/42/EEC. PENTAX Europe GmbH European Representative PENTAX Corporation Manufacturer

NOTICE These instruments are used with Class B Medical Equipment (specified EN55011) and are intended for hospital or health care districts. When used in clinical or residential areas near radio and TV receiver units, these instruments may be subjected to radio interference. To avoid and resolve adverse electromagnetic effects, do NOT operate these instruments near the RF energy equipment.

PENTAX Corporation 2-36-9, Maeno-cho, Itabashi-ku, 174-8639 Tokyo, Japan Tel. : ++81-3-3960 5155 Fax : ++81-3-5392 6724

Explanations of the symbols used in the operating manual, on the devices or on the packagings.

PENTAX Europe GmbH Julius-Vosseler-Strasse 104, 22527 Hamburg, Deutschland Tel. : ++49-40-56 192 0 Fax : ++49-40-56 042 13

Symbol for "MANUFACTURER"

Symbol for "DATE OF MANUFACTURE"

PENTAX U.K. Ltd Pentax House, Heron Drive, Langley SLOUGH SL3 8PN, Great Britain Tel. : ++44-1-75 37 92 792 Fax : ++44-1-75 37 92 794

PENTAX Italia S.r.l. Via Dione Cassio, 15 20138 MILANO, Italy Tel.: ++39-02-509958.1 Fax: ++39-02-50995860

PENTAX France S.A.S 112, quai de Bezons B.P. 204 95106 ARGENTEUIL CEDEX, France Tel. : ++33-1-30 25 75 75 Fax : ++33-1-30 25 75 76 www.pentax.fr

SISTEMAS INTEGRALES DE MEDICINA, S.A. C/Mario Cabré, 13 28030 MADRID, Spain Tel.: ++34-91 301 62 40 Fax: ++34-91 751 31 15

PENTAX Nederland B.V. Spinveld 25, 4815 HR Breda Tel. : ++31-76-531 30 31 Fax : ++31-76-531 30 00 Specifications are subject to change without notice and without any obligation on the part of the manufacturer.

Symbol for "AUTHORISED REPRESENTATIVE" SN

Symbol for "SERIAL NUMBER" In the case of endoscopes the serial number is either on the control body or the light guide connector. The serial number always has 6 digits preceded by a letter. Symbol for "BATCH CODE"

Our representative in your area:

Printed in Germany.

R02

LCPM 02/12/02/85788XX