Richard Wolf
180 mm Mini-Spoon, Both Sides 45 Deg., Cvd Upwards, Double Ended -REUSABLE
ENT Instruments Instructions Manual
6 Pages
Preview
Page 1
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Intended use The instruments listed below are used via natural and surgically created passages. Z Holding forceps, grasping forceps, clamps and thumb forceps. Removal of tissue residues and foreign bodies, holding of tissue and organs and for vessel compression. Z Punches, rongeurs, conchotomes and bone forceps are through-cutting or sharp forceps for the removal of soft tissue, cartilage or osseous tissue. Z Needle holders For intraoperative holding and guiding of surgical needles. Z Spoons and biopsy forceps For grasping and removal of tissue und tissue samples as well as for the removal of foreign bodies. Z Scissors For cutting adhesions, for preparing, dissecting and severing soft tissue, cartilage and suture material. Z Suction and irrigation tubes For aspirating secretion and/or liquid as well as for irrigation of the operating site. Z Cannulas / Syringes For the injection of liquids into the tissue or operating site Z Handles / Suction handles facilitate handling. Suction handles are used in conjuction with suction and irrigation tubes. Z Intubation tubes and trocars Allow the creation of emergency passages e.g. for tracheotomy Z Scalpels, curettes, sharp spoons, dissectors, needles, perforators: sharp severing / perforation, preparation or dissection of adhesions, soft tissue, cartilage and suture material Z Chisels, files, rasps, saws: for cutting off / removing cartilaginous and / or osseous tissue. Z Elevators, raspatories, hooks, probes for probing, elevating, and repositioning tissue structures Z Cotton wool carriers for intraoperative dabbing of liquids and tissue. Z Dilators: for dilating and enlarging surgically created passages and tissue structures. Z Knot pushers for fixing knots on intraoperative sutures Z Specula, spatulas, mouth gags, retractors, mirrors facilitate visualization of the body region to be examined or treated Z Instruments with integrated suction and irrigation canal: allow continuous aspiraton and removal of tissue particles generated during ablation, as well as the removal of secretion, blood, smoke, irrigation fluid or foreign bodies.
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Indications and field of use Diagnostic and operative interventions in the special discipline of ENT. For detailed information on indications and field of use please refer to the latest catalog pages and brochures or contact Richard Wolf GmbH or your Wolf representative. The instrument may only be used by adequately trained and qualified medical personnel.
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Contraindications To exclude the risk of trasmitting diseases, the use of such instruments in the case of TSE/BSE or similar diseases is contraindicated. This also applies to Creutzfeldt-Jacob diseases. On the basis of the patient’s general condition the doctor in charge must decide whether the planned use is possible or not. For further information please refer to the latest medical literature. WARNING ! Creutzfeldt-Jacob syndrome ! If the patient is suspected of having the Creutzfeldt-Jacob syndrome or the latter 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 regulations and laws.
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Combinations The instruments are used in conjunction with endoscopes and endoscopic accessories. The selection of instruments depends on the indication and the surgeon’s requirements. CAUTION ! When different products are combined they must be compatible in their intended use and relevant technical data (working length, diameter, etc.). Follow the instruction manuals of the products used in conjunction with these products.
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Legend and identification Symbol
Designation Caution, observe ACCOMPANYING DOCUMENTS Lot designation/no. Discardible item. Do not re--use! Steam sterilization -- fractional method Identification in conformity with Medical Devices Directive 93/42/EEC. Only valid if the product and/or package is identified with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally identified with the code no. of the notified body (0124).
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Use CAUTION The products have only limited strength! Excessive force may cause breakage or damage, impair the function and therefore endanger the patient. Due to the small dimensions required the products have only limited strength. Use these products to grasp and ablate/remove only small portions of tissue. Immediately before and after use, check the products for damage, loose parts and completeness. Ensure that no missing instrument parts remain in the patient.
CAUTION! The service life of the products identified as disposable items has been designed for single use in one patient. These instruments are supplied unsterile and must be processed before use in accordance with section 8.
. IMPORTANT! When connecting suction tubes with integrated irrigation connector be sure not to confuse the suction tube with the irrigation tube. The user must select a low-conductivity irrigation fluid suitable for the application.
6.1 Preparation Z Check assembly (see notes and instructions on assembly) Z Run through the checks (section 7) Z On instruments with Luer fitting: apply a sealing cap to the fitting.
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Checks CAUTION ! Run through the checks before and after each use. Do not use damaged products or products that are incomplete or have loose parts. Send in the damaged products together with the loose parts for repair. Do not attempt to do any repairs yourself. Z Check the instruments, in particular in the distal areas, and the accessories for damage, sharp edges, loose or missing parts and rough surfaces. Z Any lettering or identification necessary for the intended and safe use must be legible.. ' Missing or illegible lettering or identification which leads to wrong use and incorrect reprocessing must be replaced. Z Check hinge pins for hair cracks. Hinge pins may loosen if the surface is damaged. Z Cutting edges should be sharp, tips of hooks should be pointed. Z The cutting edges of the jaws should be sharp. Z The jaws should open and close easily. Z Check function of locking / ratchet mechanism(s) on the grips. Z Locking screws should open/close/turn easily. Z Check instruments with movable grips and opening tynes (jaws) for easy operation. Z Check instruments for free passage (patency).
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Reprocessing and maintenance WARNING ! Creutzfeldt-Jacob syndrome ! If the patient is suspected of having the Creutzfeldt-Jacob syndrome or the latter 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 regulations and laws.
. NOTE ! Follow the latest version of ”General notes and instructions on the reprocessing of rigid Richard Wolf endoscopes and accessories”, order no. GA-J 020, where the following procedures are described in detail
8.1 Manual reprocessing Z Wet preparation at the point of use Z Disassembly before cleaning (see notes and instructions on disassembly) Z Manual cleaning / disinfection ' Instruments with luer fitting: remove luer sealing cap and rinse out the channel with a cleaning gun. ' Instruments with suction channel: rinse out the channel with a cleaning gun or syringe. Clean clogged channels. ' Thoroughly clean the corners and recesses, channels and distal suction openings with a suitable cleaning brush.
8.2 3.2 Machine reprocessing Z Dry preparation at the point of use Z Disassembly before cleaning (see notes and instructions on disassembly) Z Machine cleaning / disinfection
8.3 Checks See section 7
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Sterilization Z Assembly before sterilization (see notes and instructions on assembly)
. IMPORTANT! Tighten screw connections only loosely before sterilization: ' to ensure a sufficient flow of sterilization medium ' to avoid stress cracks Tighten all screw connections before use. Z Steam sterilization at 134°C (272°F) using the fractional method.
10 Technical data and order data The products can be combined as required provided their relevant technical data and intended uses are observed. For the general overview please refer to the latest catalog sheets, brochures or contact Richard Wolf GmbH or your Wolf representative.
11 Spare parts and accessories Illustration
Model/type no. 887.00
Designation, Technical data Luer sealing cap
12 Operating, storage, transport and shipping conditions Operating conditions
+10°C to +40°C , 30% to 75% rel. humidity , 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 the transport or shipment of the products we recommend using the original packaging material.
12.1
Disposal of the product, packaging material and accessories
For the disposal observe the relevant regulations and laws valid in your country. ' For further information please contact the manufacturer.
GERMANY RICHARD WOLF GmbH D--75438 Knittlingen Pforzheimerstr. 32 Tel.: (..49)--(0)7043--35--0 Fax: (..49)--(0)7043--35300 MANUFACTURER E--mail: [email protected] Internet: www.richard--wolf.com USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Tel.: 847--913 1113 Fax: 847--913 14 88 E--mail: sales&[email protected] Internet: www.richardwolfusa.com UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW 17 0HB Tel.: 020--8944 7447 Fax: 020--8944 1311 E--mail: [email protected] Internet: www.richardwolf.uk.com BELGIUM N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 B--9031 Gent --Drongen Tel.: +32 9.280.81.00 Fax: +32 9.282.92.16 E--mail: [email protected] FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F--51100 Reims Tel.: +33 3.26.87.02.89 Fax: +33 3.26.87.60.33 E--mail: [email protected] AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A--1160 Wien Tel.: +43 1-- 405 51 51 Fax: +43 1-- 405 51 51--45 E--mail: [email protected] Internet: www.richard--wolf.at