Instructions. Modular Bipolar Instruments 83930xxx 84930xxx. GA -B 241 /USA--3.0/ Index: / ÄM: PDZ

Transcription

1 Instructions Modular Bipolar Instruments 83930xxx 84930xxx GA -B 241 /USA--3.0/ Index: / ÄM: PDZ

2 Important general 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 is only carried out by authorized specialized technicians. Use this product only with the combinations and with the accessories and spare parts listed in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for this use and if the performance and safety requirements are met. Reprocess the products before every application and before returning them for repair as required by the instruction manual in order to protect the patient, user or third parties. Subject to technical changes! Due to continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual. Symbol CAUTION : Federal law restricts this device to sale by or on the order of a physician. 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 surrounding.. NOTE! Tips for optimum use and other useful information. USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois Telephone: Telefax: sales&marketing@richardwolfusa.com GERMANY RICHARD WOLF GmbH Knittlingen Pforzheimerstr. 32 Telephone: Telefax: MANUFACTURER info@richard--wolf.com UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: Telefax: admin@richardwolf.uk.com BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat Gent Drongen Telephone: Telefax: endoscopy@richard--wolf.be FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette Reims Telephone: Telefax: endoscopes@richardwolf.fr AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a 1160 Vienna Telephone: Telefax: info@richard--wolf.at 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 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 0 GA--B 241

3 Contents 1 Technical description Intended use Indications and field of use Contraindications Combinations Illustration Legend and identification Use Preparation Disassembly Assembly Additional notes and instructions for use HF application Checks Visual check Function check Function test Reprocessing and maintenance Manual reprocessing Machine reprocessing Checks Sterilization Steam sterilization Gas sterilization Technical data and order data Accessories Operating, storage, transport and shipping conditions Disposal of product, packaging material and accessories Warranty and Customer Service GA--B 241 I

4 1 Technical description The Modular Bipolar Instruments consist of the following components: Z Jaw insert Z Sheath tube Z Handle 2 Intended use Under endoscopic view: Z Grasping, manipulating, cutting. Z Dissecting of soft tissue parts/organs. Z Coagulation, hemostasis, severing of tissue by means of bipolar HF current. 3 Indications and field of use For minimally invasive diagnosis and/or therapy under endoscopic control using suitable accessories in the various medical disciplines such as surgery, urology, thoracoscopy, gynecology, by adequately trained and qualified medical personnel. 4 Contraindications 5 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 modular bipolar instruments are used in conjunction with HF devices/bipolar contact coagulation and the corresponding HF cables as well as endoscopic accessories such as operating laparoscopes, trocar sleeves etc.. CAUTION! Caution if products are incorrectly combined! Possible injury of the patient, user or others as well as possible damage to the product. Different products should only be used in combination if their intended uses and relevant technical data (working length, diameter, peak voltage, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this product. Follow the Notes and instructions on HF applications, order no.: GA- S 002 as well as the HF device manufacturer s instructions. 1 GA--B 241

5 6 Illustration Consisting of : Legend and identification Item Designation Item Designation 1 Jaw insert 3 Handle 1.1 Jaw/scissor section 3.1 Bipolar H.F. connector 2 Sheath tube 3.2 Star wheel, rotatable 2.1 Sleeve 3.3 Movable grip GA--B 241 2

6 Symbols Meaning Attention, consult ACCOMPANYING DOCUMENTS REF Order number Lot identification number SN Series number 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). 3 GA--B 241

7 7 Use 7.1 Preparation 7.2 Disassembly CAUTION! The products have only limited strength! Exerting 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. Ensure that no missing instrument parts remain in the patient. Do not use products which are damaged, incomplete or have loose parts. Z Check assembly: section 7.3 Z Perform a visual check: section 7 and 7.1 Z Connect the instrument to the HF generator using the HF connection cable (see accessories). Z Check the power setting on the HF generator. Z Perform a functional check: section 7.2 Z Pull the sleeve (2.1) on the sheath tube (2) in the direction indicated by the arrow. ' The sheath tube (2) disengages from the handle (3). This causes the movable grip (3.3) to move upwards automatically.. NOTE! Do not hold the movable grip (3.3) during disassembly Z Pull the jaw insert (1) out of the sheath tube (2) while turning it slightly. 1 2 GA--B 241 4

8 7.3 Assembly. IMPORTANT! Before assembly make sure that the contacts (x) of the proximal end of the jaw insert (1) are clean, dry and undamaged. Z Insert the jaw insert (1) into the sheath tube (2) while turning it slightly. ' The twist lock mechanism locks in place. x 1 2 Z Insert the sheath tube (2) with jaw insert (1) in place into the handle (3) until the connection snaps into position with a click. ' During this the movable grip (3.3) moves down automatically.. NOTE! Do not hold the movable grip (3.3) during assembly Additional notes and instructions for use CAUTION! Exerting excessive force can cause breakage or damage to the product. Due to the small dimensions required the products have only limited strength. Additionally in the case of bipolar instruments, damage to the insulation caused by overloading can lead to electrical safety being compromised. If the coagulation effect suddenly ceases, do not increase the HF power indiscriminately, but carry out a function test (see chapter 8.2.1) as appropriate. We recommend keeping a replacement instrument available for therapeutic applications. Use the products only to grasp and remove small soft tissue parts or organs. Take particular care when handling shock sensitive ceramic components such as the scissors. Check the products for damage and completeness immediately after use. Make sure that no missing instrument parts remain in the patient. (metal and ceramic components are X- ray positive).. IMPORTANT! Insert and retract the modular bipolar instruments only with closed jaw insert/scissors (1). 5 GA--B 241

9 7.4.1 HF application Follow the Notes and instructions on HF applications, Order no.: GA--S 002 as well as the HF device manufacturer s instructions. CAUTION! Use the modular bipolar instruments in conjunction with high frequency current only up to a maximum recurring peak voltage of 300 V. The use of bipolar cutting current/cut mode is not permissible! The products are only suitable for short term coagulation of tissue and small vessels (tubular structures such as blood vessels). WARNING! Danger of injury. There is a danger of injury if the bipolar instruments are not visible through the scope! Unintentional tissue damage as well as damage to the distal end of the endoscope and other instrument parts are possible. Use the bipolar instruments only within the scope of their specifications (dielectric strength, mode etc.). Activate the bipolar instruments only if the part conducting live HF current is fully visible through the scope and is in contact with the target area. WARNING! Danger of injury! During coagulation the hinge area A must not touch any tissue to avoid inadvertent coagulation. A CAUTION! Danger of short circuit in grasping forceps! If the jaws touch each other during coagulation. The jaws must not touch each other during coagulation.. NOTE! Encrusted and soiled jaws/cutting edges impair the HF power during use. Z Wipe encrusted and soiled coagulation surfaces with 3% hydrogen peroxide solution (H 2 O 2 solution)and a pad. Z Then rinse with sterile water. GA--B 241 6

10 8 Checks CAUTION! Be careful if products are damaged or incomplete! Possible injury of patient, user or third persons. 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 loose parts for repair. Do not attempt to do any repairs yourself. 8.1 Visual check Z Check the instruments, in particular the distal areas, and the accessories for -- damage -- sharp edges -- loose or missing parts -- rough surfaces. Z Check ceramic components (scissors) for cracks. ' Replace if the ceramic cutting edge is cracked. Z Any lettering, labeling or identification necessary for the safe intended use must be legible. ' Missing or illegible lettering, labeling or identification which may lead to wrong handling and reprocessing must be restored. 8.2 Function check Function test Z Check the jaw inserts for proper opening and closing. Z Check the jaw insert for easy rotation by means of the star wheel (3.2). Z Moisten a sterile swab with sterile saline. Z Grasp the swab with the bipolar instrument. Z Activate the HF surgical device. ' The liquid in the swab is heated and evaporates. Z If no heating or insufficient heating is observed: ' Check the connection between the cable and the instrument and the cable and the device. ' Replace the cable and / or instrument if necessary. 7 GA--B 241

11 9 Reprocessing and maintenance 9.1 Manual reprocessing 9.2 Machine reprocessing 9.3 Checks 9.4 Sterilization Steam sterilization Gas sterilization Z Wet preparation at the point of use Z Disassembly before cleaning: see section 7.2 Z Manual cleaning with approved enzymatic cleaner. Z Brush and flush all channels with enzymatic cleaner and deionized water. Z Dry preparation at the point of use Z Disassembly before cleaning: see section 7.2 Z Machine cleaning with approved enzymatic cleaner. Z Follow machines instructions for use. Z Perform a visual check (see section 8.1) Modular Bipolar Instruments are to be assembled before sterilization: see section 7.3. All jaws must be in the open position for sterilization. Z Steam sterilization at 132 C (270 F) using a Pre--Vac cycle at an exposure time of 4 minutes with a 20 minute dry time. Z Gas sterilization using ethylene oxide (EtO). GA--B 241 8

12 10 Technical data and order data Product no. Designation ERAGON, bipolar handle, rotatable without lock Sheath, WL = 330 mm Sheath, WL = 240 mm ERAGON jaw section, Metzenbaum scissors ERAGON Metzenbaum scissors, assembly, diameter 5.5 mm, WL = 330 mm, consisting of: Jaw section Sheath ERAGON jaw section, Metzenbaum scissors ERAGON Metzenbaum scissors, assembly, diameter 5.5 mm, WL = 240 mm, consisting of: Jaw section Sheath Jaw section of ERAGON grasping and preparation forceps ERAGON grasping and preparation forceps, assembly, diameter 5.5 mm, WL = 330 mm, consisting of: Jaw section Sheath Jaw section of ERAGON grasping and preparation forceps ERAGON grasping and preparation forceps, assembly, diameter 5.5 mm, WL = 240 mm, consisting of: Jaw section Sheath Jaw section of ERAGON grasping and dissection forceps Maryland dissector" ERAGON grasping and dissection forceps Maryland dissector", assembly, diameter 5.5 mm, WL = 330 mm, consisting of: Jaw section Sheath Jaw section of ERAGON grasping and dissection forceps Maryland dissector" ERAGON grasping and dissection forceps Maryland dissector", assembly, diameter 5.5 mm, WL = 240 mm, consisting of: Jaw section Sheath GA--B 241

13 Jaw section of ERAGON grasping and dissection forceps Dolphin" ERAGON grasping and dissection forceps Dolphin", diameter 5.5 mm, WL = 330 mm, consisting of: Jaw section Sheath Jaw section of ERAGON grasping and dissection forceps Dolphin" ERAGON grasping and dissection forceps Dolphin", diameter 5.5 mm, WL = 240 mm, consisting of: Jaw section Sheath Jaw section ERAGON grasping forceps, with window. ERAGON grasping forceps, with window, assembly, diameter 5.5 mm, WL = 330 mm, consisting of: Jaw section Sheath Jaw section of ERAGON "Hasskamp" preparation forceps ERAGON Hasskamp" preparation forceps, complete, diameter 5.5 mm, WL = 330 mm, consisting of Jaw section Sheath 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 Richard Wolf representative. 11 Accessories Illustration Product no. Device connection Technical data HF bipolar connection cable, 3 m Wolf/Martin HF bipolar connection cable, 5 m HF bipolar connection cable, 3 m Erbe HF bipolar connection cable, 5 m HF bipolar connection cable, 3 m 2 pin Valleylab HF bipolar connection cable, 5 m 12 Operating, storage, transport and shipping conditions +10 C to+40 C, 30% to 75% rel. humidity, Operating conditions atmospheric pressure 700 hpa to 1060 hpa Storage, transport and shipping conditions -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--B

14 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 circuit or other design diagrams does not constitute 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 or servicing of Richard Wolf merchandise 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. 11 GA--B 241