Instruction Manual. Light cables GA-A 009 / USA / V2.0 / ECO (RW: V11.0 / PDB )

Transcription

1 Instruction Manual Light cables GA-A 009 / USA / V2.0 / ECO (RW: V11.0 / PDB )

2 Important general notes and instructions for use Ensure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified personnel, and that maintenance and repair are only carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned application and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Prior to each use and return shipment, reprocess the product as specified in these instructions to protect the patient, user and third parties. Subject to technical changes! Due to the continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual. CAUTION : Federal law restricts this device to sale by or on the order of a physician. Symbols Level of danger Safety instructions and levels of danger WARNING! Failure to observe can result in death or serious injury. CAUTION! Failure to observe can result in slight injury or damage to the product.. IMPORTANT! Failure to observe can result in damage to the product or surroundings.. NOTE! Tips for optimum use and other useful information. USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois Telephone: Telefax: MANUFACTURER sales&marketing@richardwolfusa.com BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat Gent Drongen Telephone: Telefax: endoscopy@richard-wolf.be Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box AL Thuraya Tower 1 9 th Floor, Room 904, Dubai Telephone: Telefax: middle.east@richard-wolf.com GERMANY RICHARD WOLF GmbH Knittlingen Pforzheimerstr. 32 Telephone: Telefax: info@richard-wolf.com FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette Reims Telephone: Telefax: endoscopes@richardwolf.fr INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32 nd Milestone Gurgaon National Capitol Region Telephone: Telefax: india@richard-wolf.com UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: Telefax: admin@richardwolf.uk.com AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a 1160 Vienna Telephone: Telefax: info@richard-wolf.at 0 GA-A 009

3 Contents 1 Technical description Intended use Indications and field of use Contraindications Combinations Overview of permissible combinations Connection to RICHARD WOLF light projectors and endoscopes with light cables of other manufacturers Connecting a RICHARD WOLF light cable to light projectors and endoscopes of other manufacturers Illustration Legend and identification Application Preparation Additional notes and instructions for use Checks Visual check Function check Reprocessing and maintenance Disassembly before cleaning Manual Reprocessing For illustrations on the reprocessing instructions see section Assembly before sterilization Reprocessing procedure Low-temperature sterilization Hydrogen peroxide plasma Gas Technical data and order data Spare parts Operating, storage, transport and shipping conditions Disposal of product, packaging material and accessories Warranty and Customer Service GA-A 009 I

4 1 Technical description Light cables are available in different versions with different fittings: Z Fiber light cable ' straight fitting at projector and endoscope ends ' angled fitting at the projector end ' angled fitting at the endoscope end ' Double fiber light cable Z Fluid light cable ' straight fitting at projector and endoscope ends Z Fiber light cable, complete, consisting of: ' Fiber light cable ' Adapter for light cable - can be unscrewed at the projector end Variant (A 1 ): for all RICHARD WOLF fiber light cables except (A 2 )(A 3 ) Variant (A 2 ): only for RICHARD WOLF high-temperature resistant fiber light cable Variant (A 3 ): only for RICHARD WOLF fiber light cable 8077.xxx - can be unscrewed at the endoscope end Variant (B 1 ): with tab, long version Variant (B 2 ): with tab, short version Variant (C 1 ): quick-release coupling (ring-operated), long version Variant (C 2 ): quick-release coupling (ring-operated), short version Z Fluid light cable, complete, consisting of: ' Fluid light cable ' Adapter for light cable - can be unscrewed at the projector end Variant (A 1 ): for all RICHARD WOLF light cables - can be unscrewed at the endoscope end Variant (B 1 ): with tab, long version 2 Intended use Light cables form the flexible connection between the light projector (projector end) and the user-specific instruments (endoscope end) e.g. telescope (endoscope), headlamp. Z Fiber light cable, complete ' Transmission of light in the visible spectral range ' Adapter for light cable (RICHARD WOLF) - Interface for light projectors and telescopes (endoscopes) of other manufacturers ' Adapter for light cable (other manufacturer) - Interface for RICHARD WOLF light projectors and telescopes (endoscopes) Z Fluid light cable, complete ' Transmission of light in the blue spectral range, e.g. - Photo Dynamic Diagnosis PDD - Diagnostic Auto Fluorescence Endoscopy DAFE ' Adapter for light cable (RICHARD WOLF) - Interface for DAFE / PDD light projectors and DAFE / PDD telescopes (endoscopes) of other manufacturers 1 GA-A 009

5 3 Indications and field of use For examination, diagnosis and therapy in conjunction with endoscopic accessories in the various medical disciplines. 4 Contraindications CJD - Creutzfeldt Jakob Disease or vcjd - Variant of Creutzfeldt-Jakob Disease BSE - Bovine Spongiform Encephalopathy; so-called mad cow disease (e.g. Creutzfeldt-Jakob Disease) TSE - Transmissible Spongiform Encephalopathy On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. Comply with the laws and regulations valid in your country. For further notes and instructions please refer to the latest medical literature. Contraindications directly related to the product are presently unknown. 5 Combinations CAUTION! Do not combine products incorrectly! Injuries to the patient, user or others as well as damage to the product are possible. Joint application of different products is only permissible if the purpose and the relevant technical data are the same (working length, diameter, etc.). Follow the instruction manuals of the products used in conjunction with this product. projector end (A) endoscope end Fig. 1 Z The light cable adapters (A) and (B) can be unscrewed from both ends and replaced by the corresponding adapters to connect light projectors and endoscopes of other manufacturers. ' see section 5.1 Overview of permissible combinations Fig. 1 (B) (C) Fig. 2 RICHARD WOLF optional As an option for the adapters (B) with tab / at the endoscope end, adapters (C) with quick-release coupling / can be used. ' see section 5.1 Overview of permissible combinations Fig. 2 GA-A 009 2

6 5.1 Overview of permissible combinations Connection to RICHARD WOLF light projectors and endoscopes with light cables of other manufacturers Adapter for light cable at projector end Fiber light cable made by Adapter for light cable at endoscope end Storz, 3.5 mm Storz, 4.8 mm Olympus-Standard Olympus WA032...A ACMI + Circon Fuji 3 GA-A 009

7 5.1.2 Connecting a RICHARD WOLF light cable to light projectors and endoscopes of other manufacturers RICHARD WOLF (A 1 ) light projector (A 2 ) * (B 2 ) (B 1 ) RICHARD WOLF telescope (endo scope) (A 3 ) (C 1 ) (C 2 ) Other brand of light projector Other brand of telescope (endoscope) Light projector made by Adapter for light cable at projector end Adapter for light cable at endoscope end Telescope (endoscope) made by ACMI + Circon ACMI + Circon Storz fits directly with assembly tool Storz Machida Fuji Pentax Olympus with assembly tool Olympus Acclarent Stryker No adapter required WOLF adapter fits only for use with light cable * for fiber light cable, high-temperature resistant GA-A 009 4

8 6 Illustration 3 A 1 /A 2 /A 3 C 1 /C 2 B 1 /B Fig Legend and identification Item Designation Item Designation 1 Fiber light cable, complete 3 Adapter for light cable 1.1 with straight fittings at the projector and endoscope ends A 1 /A 2/ A 3 at the projector end 1.2 with angled fitting at the endoscope end B 1/ B 2 at the endoscope end 1.3 with angled fitting at the projector end 1.4 Double fiber light cable 2 Fluid light cable, complete C 1/ C 2 at the endoscope end quick-release coupling, ring-operated Symbol Designation Caution, consult ACCOMPANYING DOCUMENTS! REF Order no. Lot designation Identification in conformity with EEC directive 93/42/EEC on medical products, is only valid if the product and/or its packaging is provided with this identification. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally marked with the code no. of the notified body (0124). 5 GA-A 009

9 7 Application 7.1 Preparation CAUTION! The products have only limited strength! Applying excessive force will cause damage, impair the function and therefore endanger the patient. Immediately before and after each use, check the products for damage, loose parts and completeness. Make sure that no missing parts remain in the patient. Do not use the products if they are damaged or incomplete or have loose parts. Z Remove any residues (e.g. water stains) originating from reprocessing with a cotton swab soaked with alcohol (wooden swab carrier, not metal or plastic). Z Carry out a check: see section Additional notes and instructions for use Fig. 4 CAUTION! The light cable has only limited strength! Applying excessive force and high mechanical stress can cause damage (e.g. parting of cable / light cable) and impair the function. Do no bend or twist the light cable and do not place it in an excessively small radius. Fig. 4 Fig. 5 Fig NOTE! To allow optimum light transmission, the fiber bundle diameter at the endoscope and at the light cable must be the same. Possible problems when using a light cable with ' excessive diameter: excessive heating at the coupling point with the endoscope ' insufficient diameter: reduced light output For a suitable fiber bundle diameter see the product number of the light cable. ' The code no. on the adapter for endoscopes must correspond with the 2 digits to the right of the decimal point of the product number. Exception: Fiber light cable has a fiber bundle diameter of 3.5 mm. CAUTION! Intense heat due to high light energy! Under unfavorable conditions the use of the high temperature resistant fiber light cable can cause a temperature increase at the coupling point between the fiber light cable and the endoscope. The user may burn himself and the endoscope may become damaged. Reduce the light output, or use fiber light cable no xxx / 8062.xxx if necessary. GA-A 009 6

10 WARNING! Intense heat due to high light energy! Danger of inadvertent tissue damage ' due to insufficient distance between the light exit area and the tissue ' due to soiling / contamination in the light exit area ' when using high performance light projectors. Do not touch the light exit area and avoid direct contact with the tissue. Remove any soiling or contamination. In neurosurgery use only halogen light sources up to a maximum of 250 W or other light sources (e.g. gas discharge lamps, xenon) up to a maximum of 180 W. Do not use fluid light cables. WARNING! Fire hazard! When placing the light cable onto heat-sensitive, flammable surfaces (dark drapes etc.) the heat output at the light exit area can lead to excessice heating or ignition. Put the light cable in a safe place. If the light is not needed for some time, switch off the light source. CAUTION! Danger of burns! Due to the high light energy of the light source, the adapter and glass surface of the light cable are extremely hot when disconnecting the light cable from the light projector. Burns may result from unintentional contact with the connector. Do not touch the adapter or glass surfaces of the light cable. Allow the light cableto cool down. 8 Checks CAUTION! Be careful if products are damaged or incomplete! Injuries to the patient, user or third parties are possible. Run through the checks before and after each use. Do not use products which are damaged or incomplete or have loose parts. Return damaged products together with any loose parts for repair. Do not attempt to do any repairs yourself. 8.1 Visual check Z Check the light cable for: ' damage ' sharp edges ' loose or missing parts ' rough surfaces Z Any lettering, labeling or identification necessary for the safe intended use must be legible. ' Missing or illegible inscriptions and labels that can lead to wrong handling and reprocessing must be reinstated. Z Check the outer jacket of light cable for damage (e.g. cracks, kinks). ' Do not use a damaged light cable. 7 GA-A 009

11 8.2 Function check. IMPORTANT! To avoid injuries do not connect the light cable to the light projector when carrying out any of the following measures. Z Check for secure connections. Z Check the locking mechanisms of the adapters (B) and (C) at the endoscope end. Replace the adapter if the connection ' although locked is not secure. ' cannot be locked or is difficult to lock. Z Check the glass surfaces for deposits. ' Deposits on the glass surfaces can cause a spotted or blurred field of view and therefore impair light transmission considerably. This will cause increased heat at the connectors and can lead to burns or failure of the light cable. ' Clean the glass surfaces with a swab soaked with alcohol (wooden swab carrier, not metal or plastic), wipe off hard-to-remove deposits with instrument cleaner* (Fig. 6). *see manual GA-J020 Reprocessing of RICHARD WOLF heat-stable instruments". Fig. 6 Z Hold the endoscope end of the light cable towards a bright background. ' Broken fibers appear as black dots. If approx. 30% of the fibers are broken the light output is no longer sufficient (Fig. 7). Fig. 7 Z Check the projector end of the light cable in the same way. Fluid light cable Z When carrying out a visual check of the other end, fluid light cables must not show any irregularities such as black stripes or gray surfaces. Make sure that the glass inserts at the ends are undamaged (i.e. are not scratched). ' Do not use a damaged fluid light cable. GA-A 009 8

12 9 Reprocessing and maintenance 9.1 Disassembly before cleaning projector end WARNING! Creutzfeldt-Jakob Disease! If the patient is suspected of having the Creutzfeld Jakob Disease (CJD) or avariant of a Creutzfeld Jakob Disease (vcjd) or one of these diseases has been diagnosed, adequate measures must be taken to prevent possible transmission to other patients, users and third parties. For this purpose, apply the country-specific reprocessing guidelines and regulations. Fig. 8 Z Unscrew the adapters from the projector end (A) and endoscope end (B) (C). (A) endoscope end (B) Fig. 8 (C) 9.2 Manual Reprocessing For illustrations on the reprocessing instructions see section 9.4 Fig. 9. IMPORTANT! Do not clean the plastic parts with metal or sharp-edged tools (e.g. brushes). Fig Assembly before sterilization. NOTE! Before sterilization, screw on the adapters for light cable (A) (B) (C) only loosely to allow a sufficient flow of sterilization medium. Tighten all screw connections before use. Z Screw on the adapters for light cable (A) (B) (C) only loosely, i.e. 1-2 turns. 9 GA-A 009

13 9.4 Reprocessing procedure The following pages contain information on the validated reprocessing methods for the individual products.. IMPORTANT! Due to the product design and the materials used it is not possible to define a specific limit of the maximum allowable reprocessing cycles. The life cycle of medical products is defined by their function and proper handling. Before returning defective products for repair, they must have gone through the entire reprocessing cycle. The user must make sure that the reprocessing procedure including the resources, material and personnel is suited for obtaining the required reprocessing results. The state of the art and national laws require that validated processes be followed.. IMPORTANT! Further notes and instructions on reprocessing are described in manual GA-J020 "Reprocessing of RICHARD WOLF Heat-Stable Instruments", and these must be followed. GA-A

14 Product: Fiber light cable, complete (1) Reprocessing guide: Preparation at the point of use: Transport / shipment: Directly after use, remove any coarse contamination from the fiber light cable. Do not use any fixing or setting agents or hot water (>40 C) as this will bake the residues to the surfaces and may have a negative impact on cleaning. Store the fiber light cable safely in a closed container and transport it safely to the reprocessing location to avoid damage to the fiber light cable and prevent contamination of the environment. Precleaning: Disassembly before cleaning: see section 9.1 No special requirements Cleaning: Manual cleaning Machine cleaning See section 9.2, Fig Wipe for at least 5 seconds with a sterile lint-free disposable cloth to remove any residues. 2. Immerse in a cleaning solution for at least 5 minutes. 3. Then rinse the fiber light cable thoroughly for at least 15 seconds. Place the fiber light cable onto the special holders in the washer/disinfector and fix the loose end. Vario-TD program (without disinfection cycle): ' 4 min of pre-cleaning with cold water ' Empty ' 6 min of washing with cleaning agent at 55 C ' Empty ' 3 min of neutralization *) (>40 C) ' Empty ' 2 min of intermediate rinsing with warm tap water (>40 C) ' Empty *) depending on the quality of the neutralization solution, add an acid based on citric acid. Disinfection: Drying: Function check, maintenance: Packaging: Sterilization: Primary Method Storage: Additional instructions: 1. Immerse the fiber light cable in a certified disinfectant solution, for the exposure time refer to the manufacturer's specifications. 2. Then rinse the fiber light cable thoroughly for at 15 seconds. Manual drying: Dry the fiber light cable with a sterile lint-free disposable cloth or swab. Carry out thermal machine disinfection following the national requirements regarding the A0 value (see DIN EN ISO 15883). Drying of fiber light cable using the washer/disinfector drying cycle. If necessary, additional manual drying can be achieved using a sterile lint-free disposable cloth or swab. Check visually for cleanliness. If necessary, repeat the reprocessing procedure until the fiber light cable appears clean. Carry out a visual check: see section 8.1 For sterilization pack the fiber light cable following the standard. Sterilize the fiber light cable using the fractional pre-vacuum method (ISO13060/ISO17665) in compliance with the national requirements. ' Temperature exposure time: 4 min at 132 C +4 C (270 F +7 F ) ' Drying time: 20 min ' Maximum sterilization temperature: 138 C Store the sterilized fiber light cable in a dry, clean and dust-free environment at moderate temperatures of 5 C to 40 C. It is responsibility of the user to ensure that the reprocessing equipment has been installed, calibrated and validated according to manufacturer specifications. 11 GA-A 009

15 Product: Fluid light cable, complete (2) Reprocessing guide: Preparation at the point of use: Transport / shipment: Precleaning: Directly after use,remove any coarse contamination from the fluid light cable. Do not use any fixing or setting agents or hot water (>40 C) as this will bake the residues to the surfaces and may have a negative impact on cleaning. Store the fluid light cable safely in a closed containerand transport it safely to the reprocessing location to avoid damage to the fiber light cable and prevent contamination of the environment. No special requirements Cleaning: Manual cleaning Machine cleaning See section 9.2, Fig Wipe for at least 5 seconds with a sterile lint-free disposable cloth to remove any residues. 2. Immerse in a cleaning solution for at least 5 minutes. 3. Then thoroughly rinse the fluid light cable for at least 15 seconds. Do not expose the fluid light cable to automatic machine cleaning. Disinfection: Drying: Function check, maintenance: Packaging: Sterilization: Primary Method Storage: Additional instructions: 1. Immerse the fluid light cable only in a certified disinfectant solution, for the exposure time refer to the manufacturer's specifications. 2. Then thoroughly rinse the fluid light cable for at least 15 seconds. Manual drying: Dry the fluid light cable using a sterile lint-free disposable cloth or swab. Check visually for cleanliness. Repeat the reprocessing procedure if required until the fluid light cable appears clean. Carry out a visual check: see section 8.1 For sterilization, package the fluid light cable following the standard. Sterilization the fluid light cable using the low-temperature hydrogen peroxide plasma method (STERRAD) following the sterilizer manufacturer instructions. Fluid light cables can not be steam sterilized. Store the sterilized fluid light cable in a dry, clean and dust-free environment at moderate temperatures of 5 C to 35 C. It is responsibility of the user to ensure that the reprocessing equipment has been installed, calibrated and validated according to manufacturer specifications. GA-A

16 Product: Adapter for light cables (3) / adapter for endoscopes Reprocessing guide: Preparation at the point of use: Transport / shipment: Directly after use, remove any coarse contamination from the adapters. Do not use any fixing or setting agents or hot water (>40 C) as this will bake the residues to the surfaces and may have a negative impact on cleaning. Safe storage in a closed container and safe transport of the adapters to the reprocessing location in order to avoid damage to the adapters and prevent contamination of the environment. Precleaning: Disassembly before cleaning: see section 9.1 No special requirements Cleaning: Manual cleaning Machine cleaning See section 9.2, Fig Brush inside and out for at least 5 seconds with a soft brush to remove any residues. 2. Immerse in a cleaning solution for at least 5 minutes. 3. Then rinse the adapter thoroughly for at least 15 seconds. Place the adapter into the small parts sieve in the washer/ disinfector. Vario-TD program (without disinfection cycle): ' 4 min of pre-cleaning with cold water ' Empty ' 6 min of washing with cleaning agent at 55 C ' Empty ' 3 min of neutralization *) (>40 C) ' Empty ' 2 min of intermediate rinsing with warm tap water (>40 C) ' Empty Disinfection: Drying: Function check, maintenance: Packaging: Sterilization: Primary Method Storage: Additional instructions: 1. Immersetheadapterinacertified disinfectant solution, for exposure time refer to the manufacturer's specifications. 2. Then rinse the adapter thoroughly for at least 15 seconds using fully demineralized water. Manual drying: Dry outside of adapter with a sterile lint-free disposable cloth or swab, dry hollow spaces with filtered compressed air. *) depending on the quality of the neutralization solution, add an acid based on citric acid. Carry out thermal machine disinfection following the national requirements regarding the A0 value (see DIN EN ISO 15883). Drying of light cable adapters in the washer / disinfector drying cycle. If necessary, additional manual drying can be achieved using a sterile lint-free disposable cloth or swab. Dry hollow spaces with filtered compressed air. Check visually for cleanliness. Repeat the reprocessing procedure if required until the adapter appears clean. Assembly before sterilization: see section 9.3 Carry out a visual check: see section 8.1 For sterilization, package the adapters as required by the standards. Sterilize the adapters using the fractional pre-vacuum method (ISO13060/ISO17665) in compliance with the national requirements. ' Temperature exposure time: 4 min at 132 C +4 C (270 F +7 F ) ' Drying time: 20 min ' Maximum sterilization temperature: 138 C Store the adapters in a dry, clean and dust-free environment at moderate temperatures of 5 C to40 C. It is responsibility of the user to ensure that the reprocessing equipment has been installed, calibrated and validated according to manufacturer specifications. 13 GA-A 009

17 9.5 Low-temperature sterilization. IMPORTANT! Follow the sterilizer manufacturer instructions for low-temperature sterilization Hydrogen peroxide plasma Gas Z STERRAD 50 / 100S / 200 / NXt and 100 NXt Z Ethylene oxide gas (EO) Z Hydrogen peroxide vapor (V-PRO 1 and V-PRO 1 Plus) GA-A

18 10 Technical data and order data PRODUCT NO DESIGNATION, TECHNICAL DATA Fiber bundle diameter = Ø working length = WL Fluid light cable, complete; dia. Ø = 3.0 mm; WL= 2.3 m dia. Ø = 1.6 mm; WL = 1.8 m dia. Ø = 2.5 mm; WL = 1.8 m dia. Ø = 2.5 mm; WL = 2.3 m dia. Ø = 2.5 mm; WL = 3.0 m dia. Ø = 3.5 mm; WL = 1.8 m dia. Ø = 3.5 mm; WL = 2.3 m dia. Ø = 3.5 mm; WL = 3.0 m dia. Ø = 4.5 mm; WL = 2.3 m dia. Ø = 4.5 mm; WL = 3.0 m dia. Ø = 4.5 mm; WL = 2.3 m dia. Ø = 3.5 mm; WL = 2.3 m Double fiber light cable, complete; Ø = 2x3.5 mm; WL = 1.8 m dia. Ø = 2.5 mm; WL = 2.3 m dia. Ø = 3.5 mm; WL = 2.3 m dia. Ø = 4.5 mm; WL = 2.3 m high-temperature resistant; dia. Ø = 3.5 mm; WL = 2.3 m ADAPTER FOR LIGHT CABLE projector end endoscope end (A 1 ) (A 2 ) (A 3 ) (B 1 ) (B 2 ) (C 1 ) (C 2 ) D d d D d d d D d d d D d D d D d D d d d Legend: D = combination possible d = combination not possible The products can be combined as required provided the relevant technical data and intended uses are observed. For the general overview, please refer to the latest catalog sheets, brochures or contact Richard Wolf or your representative. 15 GA-A 009

19 11 Spare parts ILLUSTRATION PRODUCT NO. DESIGNATION ADAPTER FOR LIGHT CABLE on projector end (A 1 ) on projector end (A 2 ) only for on projector end (A 3 ) only for 8077.xxx on endoscope end (B 1 ) on endoscope end (B 2 ) only for fiber light cable dia. Ø = 1.6 mm on endoscope end (C 1 ) on endoscope end (C 2 ) quick-release coupling (ring-operated), long version quick-release coupling (ring-operated), short version only for fiber bundle dia. Ø = 1.6 mm ASSEMBLY WRENCH FOR Operating, storage, transport and shipping conditions Operating conditions: Storage, transport and shipping conditions: Fiber light cable Storage, transport and shipping conditions: Fluid light cable +10 C to+40 C, 30% to 75% rel. Humidity, atmospheric pressure 700 hpa to 1060 hpa -20 C to+60 C, 10% to 90% rel. Humidity, atmospheric pressure 700 hpa to 1060 hpa -5 C to+35 C, 30% to 100% rel. Humidity, atmospheric pressure 700 hpa to 1060 hpa. NOTE! To prevent damage during transport or shipment of the products we recommend using the original packaging material Disposal of product, packaging material and accessories For the disposal observe the laws and regulations valid in your country. ' For further information please contact the manufacturer. GA-A

20 13 Warranty and Customer Service Richard Wolf guarantees our instruments to be free from any defects in materials and workmanship under normal use and service for one year. Richard Wolf general terms and conditions may be found on the back of our invoice. Parts delivered separately by Richard Wolf are subject to all of the same general terms and conditions for our products, including the limitations of warranty and liability. All products should be returned to Richard Wolf for any necessary or desired repair or part replacement. No product repair or part replacement should be done other than by Richard Wolf unless the care and instruction manual or other written information indicates that repair or part replacement is authorized. If authorized, parts must be replaced only by parts supplied or specified by Richard Wolf,and productrepair and part replacement must be done in strict conformance with Richard Wolf specifications and instructions for repair and part replacement, including post replacement testing and recalibration. Failure to follow this requirement in any way can be dangerous to you, your personnel and your patients and voids the warranty for the product repaired or the product in which the part was replaced and if the part was supplied by Richard Wolf, for that part. Delivery by Richard Wolf of technical documents such as circuitor otherdesign diagrams does notconstitute authorization for product repair or part replacement. Richard Wolf instruments and other products should never be modified or altered under any circumstances. Contact Richard Wolf if you have any question (1) whether replacement of a part or a repair is authorized by Richard Wolf, or (2) whether you have complete instructions and specifications for part replacement or repair. These instructions do not attempt to cover all details or variations in equipment, nor to provide for every possible contingency to be met in connection with installation, operation, or maintenance. Should further information be required or should problems arise which are not covered sufficiently for the purchaser's purpose, the matter should be referred to Richard Wolf Medical Instruments Corporation. Our national sales and service offices, as well as our manufacturing facility, are located in Illinois. Trained manufacturer's representatives are located throughout the U.S. to serve you. For any questions regarding these instruments, or to place an order, contact Richard Wolf customer service department at or WOLF (9653). INSTRUMENT ORDERING POLICY Richard Wolf reserves the right to make substitutions, if necessary, without prior notice. REPAIR POLICY Defective merchandise will be repaired or replaced at no charge to the customer, provided the customer delivers such defective merchandise prepaid.any repairs,maintenance orservicing ofrichard Wolfmerchandise by anyone other than a factory authorized representative will render our warranty null and void. REPAIR SHIPMENTS When returning your instrument for repair, we suggest that you prevent shipping damage to the instrument by reusing the box that it was originally shipped in. Richard Wolf also recommends that the instrument be insured for an amount to cover the cost of replacement. IMPORTANT For general safety and health reasons, Richard Wolf requires that you clean and sterilize all instruments before returning them for repair. If instruments are received in an unsanitary condition, Richard Wolf will clean and sterilize each instrument and add a $ cleaning charge for each instrument requiring cleaning. 17 GA-A 009