Instruction Manual. Operating Laparoscopes xxx/8914.xxx/8915.xxx/

Transcription

1 Instruction Manual Operating Laparoscopes 8912.xxx/8914.xxx/8915.xxx/ GA-E 191 / USA / V2.0 / ECO (RW: / PDI )

2 Important general notes and instructions for use Make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical 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. Reprocess the products in accordance with the manual before every use and before return shipment to protect the patient, user and third parties. Immediately upon receipt, check the product and its accessories for completeness and possible damage. Should the shipment give right to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments, the illustrations and technical data may deviate slightly. CAUTION : Federal law restricts this device to sale by or on the order of a physician. Safety instructions and levels of danger Symbols Level 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 Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois Toll Free: 001 (800) Phone: 001 (847) Fax: 001 (847) MANUFACTURER sales@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 F Reims Telephone: Telefax: france@richard-wolf.com 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 A-1160 Vienna Telephone: Telefax: austria@richard-wolf.com 0 GA-E 191

3 Contents 1 Intended use Indications and field of application Contraindications Combinations Illustration OP-Laparoscope Legend and identification Insertion cock / Insertion valve Legend and identification Use Preparation Connection insertion valve Connecting insertion stopcock Connecting insertion stopcock Additional instructions for use Checks Visual check Functional check Reprocessing and maintenance Manual reprocessing Machine reprocessing Checks Assembly before sterilization Sterilization Steam sterilization Alternate Sterilization Methods Technical data and order data Spare parts Operating, storage and transport and shipping conditions Disposal of product, packaging material and accessories Warranty and Customer Service... 9 GA-E 191 I

4 1 Intended use The OP laparoscopes are used for viewing the interior of the patient via surgical accesses produced by surgery. 2 Indications and field of application For examination, diagnosis and therapy in connection with endoscopic accessories for laparoscopy and in thoracoscopy. 3 Contraindications 4 Combinations Contraindications directly related to the product are presently unknown. On the basis of the patient's general condition the physician/surgeon in charge must decide whether the planned use is possible or not. For further information see the latest medical literature. The laparoscopes are used in connection with light sources and flexible light guides, video cameras or reflex cameras and objective lenses, as well as accessories for endoscopic use (e.g. such as trocar sleeves, forceps, electrodes). CAUTION! When different products are combined it is necessary that they are compatible in their intended use and relevant technical data (working length, diameter, etc.). Observe the instruction manuals of the products used in combination with this product. fig. 1 Z The cold light connector (1.8) can be unscrewed (figure 1) and replaced by respective adapters in order to connect flexible light guides of other makes. For order information see the current catalogue sheet. Z Accessories for endoscopy with 5 mm, 7 mm and 8 mm outer diameters, depending on the respective working channel and working length. Z Objective lenses with C-mount thread for working via monitor. For order information please see the current catalogue sheet GA-E 191

5 5 Illustration 5.1 OP-Laparoscope A x AUTOCLAVE x AUTOCLAVE B Legend and identification Item Designation Item Designation Meaning A OP Laparoscope; angled eyepiece 1.9 Ring Steam sterilization using Pre--Vac B OP Laparoscope; oblique eyepiece 1.10 Autoclave cycle at 270_F (132_C) 1.1 Sheath tube 1.11 projecting ring Increased object field, high detail resolution 1.2 Working channel 1.3 Insufflation cock Eyepiece funnel Color ring blue:viewing direction 0_ green: Viewing direction 10_ 1.5 Serial number 1.13 Symbol for insertion cock/ 1.6 Model number insertion valve 1.7 Indication of viewing direction 1.8 Cold light connection <60 Identification in conformity with Medical Devices Directive 93/42/EEC only valid if the product and/or packaging is marked with this symbol. 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 number of the notified body (0124). GA-E 191 2

6 5.2 Insertion cock / Insertion valve 2a b Legend and identification 2a Insertion valve Insertion stopcock Union nut 3.1 Union nut 2.2 Membrane seal 3.2 Sealing cap 2.3 Sealing lid 3.3 Pin 2.4 Sealing cap 4 Insertion stopcock b Automatic insertion valve Union nut 4.2 Sealing cap 4.3 Pin 3 GA-E 191

7 6 Use 6.1 Preparation CAUTION! The products have only limited strength! Exerting excessive force will cause damage, impair the function and thus endanger the patient. Directly before and after each use, check the products for loose parts and completeness. Ensure that no missing instrument parts remain in the patient. Z Check assembly (chapter 8.4) Z Run through the checks (chapter 7). NOTE! For easier insertion wet auxiliary instruments with a sterile fluid. 6.2 Connection insertion valve Z Connect insertion valve (2) with OP laparoscope (1) and fix by tightening union nut (2.1). (Fig. 2) Fig Connecting insertion stopcock Z Connect insertion stopcock (3) with OP laparoscope (1) so that pin (3.3) engages in bore (a) (Fig. 3) Z Tighten union nut (3.1) to lock the connection. 2 Fig a Connecting insertion stopcock Z Connect insertion stopcock (4) with OP laparoscope (1) so that pin (4.3) engages in bores (b) (Fig.4) Z Tighten union nut (4.1) to lock the connection Fig. 4 b GA-E 191 4

8 6.5 Additional instructions for use. IMPORTANT! Z Use only products with application parts of CF/BF classification in combination with the endoscope. Z For maximum light output the glass fiber cross section of the flexible light guide and the endoscope must be the same. WARNING! Due to high light energy heat might develop. Insufficient spacing between the light exit area and the tissue may lead to the destruction of the tissue. Do not touch the light exit area and avoid direct contact with the tissue. fig. 5 CAUTION! HF sparking Insufficient spacing between the live HF parts and other conductive parts may lead to undesired damage of the tissue and to damage of the OP laparoscope. Whenever HF instruments are used activate those only when their live HF part is at least 10 mm away from the tip of the OP laparoscope and when the instrument tip is in safe contact with the tissue to which the current is to be applied. Spray coagulation is not permissible. (fig. 5). When using HF current, please follow the relevant instructions for use. WARNING! Danger of burns and fire due to high light energy! Do not place the light exit area against heat-sensitive, flammable surfaces (dark cloths, drapes, etc.) as this may lead to overheating or ignition. Switch off the light source whenever the endoscope will not be used for a prolonged period of time. CAUTION! Burns due to leakage currents when high frequency current is used! Risk of eye and face burns for the operator/surgeon. Use the endoscopes only with the eye piece funnel attached. CAUTION! Increased potential of danger if image is blurred! Danger of injuring the patient. Stop operation if image is blurred. Check image quality of endoscope before use. 7 Checks. IMPORTANT! Run through the checks before and after each use. 7.1 Visual check. IMPORTANT! Do not use products that are damaged or incomplete or have loose parts. Return damaged products together with loose parts for repair. Do not attempt to do any repairs yourself. Z Before and after each use check instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces. Z Any lettering, labeling and identification necessary for the safe intended use must be legible. ' Missing or illegible lettering, labeling and identifications which may lead to wrong handling or reprocessing must be restored or the parts discarded. Z Check sealing caps and membrane valves for damage and replace if necessary. 5 GA-E 191

9 7.2 Functional check Checking image quality and light outout: Z Deposits on glass surfaces may cause stained or blurred vision and considerably impair light transmission. ' Clean glass surfaces with a swab moistened with alcohol (wooden swab carrier, not metal or plastic), remove difficult-to-remove deposits with instrument cleaner* (fig. 6) fig. 6 Z Deposits on the light entry and exit surfaces can reduce light transmission considerably. ' Clean light entry and exit surfaces with a swab moistened with alcohol (wooden swab carrier, not metal or plastic); remove difficult-to-remove deposits with instrument cleaner*. Z Hold the distal end of the endoscope towards a light source (fig. 7) ' Broken fibers appear as black dots in the connector for cold light (1.8). If more than 30% of the fibers are broken, the light output is no longer sufficient. fig GA-E 191 6

10 8 Reprocessing and maintenance 8.1 Manual reprocessing. NOTE! Follow the latest notes and instructions in the GA-J020 Manual on the Reprocessing of RICHARD WOLF Heat-Stable Instruments. Z Decontamination by immersion in an approved enzymatic cleaner Z Disassembly of insertion valve (fig.8) ' Remove sealing cap (2.4) ' Unscrew sealing lid (2.3) ' Remove membrane seal (2.2). fig Machine reprocessing 8.3 Checks Z Manual cleaning / disinfection ' Rinse OP laparoscopes first with cold and then with warm water. Clean light entry and exit surfaces as well as glass surfaces with a cotton swab. Z Dry preparation for reprocessing. Z Disassembly before cleaning ' Same procedure as described under manual reprocessing Z Machine cleaning / disinfection ' To prevent damage to the washer place all OP laparoscopes into a special telescope reprocessing basket. see chapter Assembly before sterilization Z Assemble insertion valve in reverse order as described under disassembly. Replace membrane seal (2.2) with a new one. 8.5 Sterilization Steam sterilization Z Steam sterilization in Pre-Vac cycle at 270 F(132 C) with 4 minutes exposure time and 20 minutes dry time Alternate Sterilization Methods Z For possible alternate sterilization methods, refer to our website, under Reprocessing & Sterilization for lists of Richard Wolf instruments that are approved for various reprocessing methods. 7 GA-E 191

11 9 Technical data and order data Model number Designation Viewing direction Working length External diameter Working channel PANOVIEW PLUS OP laparoscope, angled mm 10 mm 5mm PANOVIEW PLUS OP laparoscope, mm 10 mm 5mm angled, distortion-free PANOVIEW PLUS OP laparoscope, oblique, distortion-free PANOVIEW PLUS OP Laparoscope, angled, with stop mm 10 mm 5mm mm 12,5 mm 7,3 mm OP-Thoracoscope mm 7mm 3mm 10 Spare parts Item Order number Designation 2.4, BL (pkg of 12) Sealing cap blue (pkg of 10) Membrane seal Cold light connector YE (pkg of 12) Sealing cap yellow Illustration Order number Designation Stop, for using the Hulka Clip Applicator together with PANOVIEW OP Laparoscope 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 and brochures, or contact Richard Wolf or your R.Wolf representative. 11 Operating, storage and transport and shipping conditions. Operating conditions Storage, transport and shipping conditions +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. 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 regulations and laws valid in your country. ' For further information please contact the manufacturer. GA-E 191 8

12 12 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. 9 GA-E 191