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GA--B 241 / USA--3.0 / Index: 04--10--3.0 / ÄM: PDZ 10--4316
Modular Bipolar Instruments
83930xxx
84930xxx
Instructions
0 GA--B 241
Important general instructions for useEnsure that this product is used only as intended and described in this instruction manual, by ad-equately trained and qualified personnel, and that maintenance and repair is only carried out byauthorized specialized technicians.
Use this product only with the combinations and with the accessories and spare parts listed inthis instruction manual. Use other combinations, accessories and replacement parts only if theyare 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 requiredby 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 deviateslightly from the data in this manual.
CAUTION :Federal law restricts this device to sale by or on the order of a physician.
Safety instructions and levels of danger
Symbol 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 surrounding.
. NOTE!Tips for optimum use and other useful information.
USARICHARD WOLFMedical Instruments Corp.353 Corporate Woods ParkwayVernon Hills, Illinois 60061Telephone: +1 847--913--1113Telefax: +1 847--913--1488sales&[email protected]
GERMANYRICHARD WOLF GmbH75438 KnittlingenPforzheimerstr. 32Telephone: +49 70 43 35--0Telefax: +49 70 43 [email protected]
UKRICHARD WOLF UK Ltd.Waterside WayWimbledonSW17 0HBTelephone: + 44 20 89 44 74 47Telefax: + 44 20 89 44 1311 [email protected]
BELGIUM / NETHERLANDSN.V. EndoscopieRICHARD WOLF Belgium S.A.Industriezone DrongenLandegemstraat 69031 Gent DrongenTelephone: +32 92 80 81 00Telefax: +32 92 82 92 [email protected]
FRANCERICHARD WOLF France S.A.R.L.Rue Daniel BergerZ.A.C. La Neuvillette51100 ReimsTelephone: +33 3 26 87 02 89Telefax: +33 3 26 87 60 33
AUSTRIARICHARD WOLF AustriaGes.m.b.H.Wilhelminenstraße 93 a1160 ViennaTelephone: +43 14 05 51 51Telefax: +43 14 05 51 51 [email protected]
Marketing OfficeU.A.ERICHARD WOLF Middle EastP.O. Box 500283AL Thuraya Tower 19th Floor,Room 904, DubaiTelephone: + 9 71 43 68 19 20Telefax: + 9 71 43 68 61 12
INDIARICHARD WOLF India Private Ltd.JMD Pacific SquareNo. 211 A, Second FloorBehind 32nd MilestoneGurgaon -- 122 001National Capitol RegionTelephone: + 91 12 44 31 57 00Telefax: + 91 12 44 31 57 05
Contents
IGA--B 241
1 Technical description 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 Intended use 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 Indications and field of use 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 Contraindications 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 Combinations 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 Illustration 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.1 Legend and identification 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7 Use 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.1 Preparation 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.2 Disassembly 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.3 Assembly 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.4 Additional notes and instructions for use 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.4.1 HF application 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8 Checks 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.1 Visual check 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.2 Function check 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.2.1 Function test 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9 Reprocessing and maintenance 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.1 Manual reprocessing 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.2 Machine reprocessing 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.3 Checks 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.4 Sterilization 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.4.1 Steam sterilization 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9.4.2 Gas sterilization 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10 Technical data and order data 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11 Accessories 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12 Operating, storage, transport and shipping conditions 10. . . . . . . . . . . . . . . . . . . . . .12.1 Disposal of product, packaging material and accessories 10. . . . . . . . . . . . . . . . . . . . . . . .
13 Warranty and Customer Service 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 GA--B 241
1 Technical descriptionThe Modular Bipolar Instruments consist of the following components:Z Jaw insertZ Sheath tubeZ Handle
2 Intended useUnder endoscopic view:Z Grasping, manipulating, cutting.Z Dissecting of soft tissue parts/organs.Z Coagulation, hemostasis, severing of tissueby means of bipolar HF current.
3 Indications and field of useFor minimally invasive diagnosis and/or therapy under endoscopic control usingsuitable accessories in the various medical disciplines such as surgery, urology,thoracoscopy, gynecology, by adequately trained and qualified medical personnel.
4 ContraindicationsContraindications directly related to the product are presently unknown.On the basis of the patient’s general condition the physician/surgeon in chargemust decide whether the planned use is possible or not. For further informationsee the latest medical literature.
5 CombinationsThe modular bipolar instruments are used in conjunction with HF devices/bipolarcontact coagulation and the corresponding HF cables as well as endoscopic ac-cessories 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 theproduct.Different products should only be used in combination if their intended usesand relevant technical data (working length, diameter, peak voltage, etc.) arethe same.Follow the instruction manuals of the products used in conjunction withthis product.Follow the “Notes and instructions on HF applications“, order no.: GA-S 002as well as the HF device manufacturer’s instructions.
2GA--B 241
6 Illustration
1
2
3
3.23.1
2.11.1
3.3
Consisting of :
6.1 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
3 GA--B 241
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/orpackaging is marked with this symbol. Products of category IIa and above, as well as sterileproducts or products with measuring function of category I, are additionally marked with the codenumber of the notified body (0124).
4GA--B 241
7 UseCAUTION!The products have only limited strength!Exerting excessive force will cause damage, impair the function and thereforeendanger 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.
7.1 PreparationZ Check assembly: section 7.3Z Perform a visual check: section 7 and 7.1Z 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
7.2 DisassemblyZ 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 mov-able grip (3.3) to move upwards automatically.
. NOTE !Do not hold the movable grip (3.3) during disassembly.
2 2.1
3.3
3
Z Pull the jaw insert (1) out of the sheath tube (2) while turning it slightly.
1 2
5 GA--B 241
7.3 Assembly. IMPORTANT !
Before assembly make sure that the contacts (x) of the proximal end of the jawinsert (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.
1 2
Z Insert the sheath tube (2) with jaw insert (1) in place into the handle (3) untilthe 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.
2
33.3
7.4 Additional notes and instructions for useCAUTION!Exerting excessive force can cause breakage or damage to the product.Due to the small dimensions required the products have only limitedstrength.
Additionally in the case of bipolar instruments, damage to the insulationcaused by overloading can lead to electrical safety being compromised. Ifthe coagulation effect suddenly ceases, do not increase the HF power indis-criminately, but carry out a function test (see chapter 8.2.1) as appropriate.We recommend keeping a replacement instrument available for therapeuticapplications.
Use the products only to grasp and remove small soft tissue parts or or-gans.Take particular care when handling shock sensitive ceramic componentssuch as the scissors.
Check the products for damage and completeness immediately after use.Make sure that no missing instrument parts remain in the patient. (metaland ceramic components are X- ray positive).
. IMPORTANT!Insert and retract the modular bipolar instruments only with closed jaw insert/scis-sors (1).
x
6GA--B 241
7.4.1 HF applicationFollow the “Notes and instructions on HF applications”, Order no.: GA--S 002 aswell as the HF device manufacturer’s instructions.
CAUTION!Use the modular bipolar instruments in conjunction with high frequencycurrent 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 andsmall vessels (tubular structures such as blood vessels).
WARNING !Danger of injury. There is a danger of injury if the bipolar instruments arenot visible through the scope !Unintentional tissue damage as well as damage to the distal end of the en-doscope 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 currentis 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 avoidinadvertent coagulation.
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 (H2O2 solution)and a pad.Z Then rinse with sterile water.
A
7 GA--B 241
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 checkZ 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 usemust be legible.'Missing or illegible lettering, labeling or identification which may lead towrong handling and reprocessing must be restored.
8.2 Function checkZ 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).
8.2.1 Function testZ 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 cableand the device.
'Replace the cable and / or instrument if necessary.
8GA--B 241
9 Reprocessing and maintenance
9.1 Manual reprocessingZ Wet preparation at the point of useZ Disassembly before cleaning: see section 7.2Z Manual cleaning with approved enzymatic cleaner.Z Brush and flush all channels with enzymatic cleaner and deionized water.
9.2 Machine reprocessingZ Dry preparation at the point of useZ Disassembly before cleaning: see section 7.2Z Machine cleaning with approved enzymatic cleaner.Z Follow machines instructions for use.
9.3 ChecksZ Perform a visual check (see section 8.1)
9.4 SterilizationModular Bipolar Instruments are to be assembled before sterilization:see section 7.3.All jaws must be in the open position for sterilization.
9.4.1 Steam sterilizationZ 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.
9.4.2 Gas sterilizationZ Gas sterilization using ethylene oxide (EtO).
9 GA--B 241
10 Technical data and order dataProduct no. Designation839300102 ERAGON, bipolar handle, rotatable without lock83930921 Sheath, WL = 330 mm84930921 Sheath, WL = 240 mm83930041 ERAGON jaw section, Metzenbaum scissors
839300412
ERAGON Metzenbaum scissors, assembly, diameter 5.5 mm, WL = 330 mm,consisting of:Jaw section 83930041Sheath 83930921Handle 839300102
84930041 ERAGON jaw section, Metzenbaum scissors
849300412
ERAGON Metzenbaum scissors, assembly, diameter 5.5 mm, WL = 240 mm,consisting of:Jaw section 84930041Sheath 84930921Handle 839300102
83930031 Jaw section of ERAGON grasping and preparation forceps
839300312
ERAGON grasping and preparation forceps, assembly,diameter 5.5 mm, WL = 330 mm, consisting of:Jaw section 83930031Sheath 83930921Handle 839300102
84930031 Jaw section of ERAGON grasping and preparation forceps
849300312
ERAGON grasping and preparation forceps, assembly,diameter 5.5 mm, WL = 240 mm, consisting of:Jaw section 84930031Sheath 84930921Handle 839300102
83930032 Jaw section of ERAGON grasping and dissection forceps “Maryland dissector"
839300322
ERAGON grasping and dissection forceps “Maryland dissector", assembly,diameter 5.5 mm, WL = 330 mm, consisting of:Jaw section 83930032Sheath 83930921Handle 839300102
84930032 Jaw section of ERAGON grasping and dissection forceps “Maryland dissector"
849300322
ERAGON grasping and dissection forceps “Maryland dissector", assembly,diameter 5.5 mm, WL = 240 mm, consisting of:Jaw section 84930032Sheath 84930921Handle 839300102
10GA--B 241
83930033 Jaw section of ERAGON grasping and dissection forceps “Dolphin"
839300332
ERAGON grasping and dissection forceps “Dolphin",diameter 5.5 mm, WL = 330 mm, consisting of:Jaw section 83930033Sheath 83930921Handle 839300102
84930033 Jaw section of ERAGON grasping and dissection forceps “Dolphin"
849300332
ERAGON grasping and dissection forceps “Dolphin",diameter 5.5 mm, WL = 240 mm, consisting of:Jaw section 84930033Sheath 84930921Handle 839300102
83930034 Jaw section ERAGON grasping forceps, with window.
839300342
ERAGON grasping forceps, with window, assembly,diameter 5.5 mm, WL = 330 mm, consisting of:Jaw section 83930034Sheath 83930921Handle 839300102
83930035 Jaw section of ERAGON "Hasskamp" preparation forceps
839300352
ERAGON “Hasskamp" preparation forceps, complete,diameter 5.5 mm, WL = 330 mm, consisting ofJaw section 83930035Sheath 83930921Handle 839300102
The products can be combined as required provided the relevant technical data and intended uses are ob-served. For the general overview please refer to the latest catalog sheets and brochures, or contact RichardWolf or your Richard Wolf representative.
11 AccessoriesIllustration Product no. Device connection Technical data
8108.131Wolf/Martin
HF bipolar connection cable, 3 m8108.151 HF bipolar connection cable, 5 m8108.132
ErbeHF bipolar connection cable, 3 m
8108.152 HF bipolar connection cable, 5 m8108.133
2 pin ValleylabHF bipolar connection cable, 3 m
8108.153 HF bipolar connection cable, 5 m
12 Operating, storage, transport and shipping conditions
Operating conditions +10C to +40C , 30% to 75% rel. humidity,atmospheric pressure 700 hPa to 1060 hPa
Storage, transport and shipping conditions - 20C to +60C , 10% to 90% rel. humidity,atmospheric pressure 700 hPa to 1060 hPa
. NOTE !To prevent damage during transport or shipment of the products we recommendusing the original packaging material.
12.1 Disposal of product, packaging material and accessoriesFor the disposal observe the regulations and laws valid in your country.' For further information please contact the manufacturer.
11 GA--B 241
13 Warranty and Customer Service
RichardWolf guarantees our instruments to be free fromany defects inmaterials andworkmanshipundernormal use and service for one year. Richard Wolf general terms and conditions may be found on theback of our invoice.
Parts delivered separately by RichardWolf are subject to all of the samegeneral terms and conditions forour 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 andinstruction manual or other written information indicates that repair or part replacement is authorized. Ifauthorized, partsmust be replaced only by parts supplied or specified byRichardWolf,and product repairand part replacement must be done in strict conformance with Richard Wolf specifications andinstructions for repair and part replacement, including post replacement testing and recalibration. Failureto follow this requirement in any way can be dangerous to you, your personnel and your patients andvoids the warranty for the product repaired or the product in which the part was replaced and if the partwas supplied by Richard Wolf, for that part.
Delivery by Richard Wolf of technical documents such as circuit or other design diagrams does notconstitute authorization for product repair or part replacement. Richard Wolf instruments and otherproducts should never be modified or altered under any circumstances.
Contact RichardWolf if you have any question (1) whether replacement of a part or a repair is authorizedbyRichardWolf, or (2)whether you have complete instructions and specifications for part replacement orrepair.
These instructions do not attempt to cover all details or variations in equipment, nor to provide for everypossible contingency to bemet in connection with installation, operation, ormaintenance. Should furtherinformation be required or should problems arise which are not covered sufficiently for the purchaser’spurpose, the matter should be referred to Richard Wolf Medical Instruments Corporation.
Our national sales and service offices, as well as ourmanufacturing facility, are located in Illinois. Trainedmanufacturer’s representatives are located throughout the U.S. to serve you. For any questionsregarding these instruments, or to place an order, contact Richard Wolf customer service department at847--913--1113 or 800--323--WOLF (9653).
INSTRUMENT ORDERING POLICYRichard Wolf reserves the right to make substitutions, if necessary, without prior notice.
REPAIR POLICYDefective merchandise will be repaired or replaced at no charge to the customer, provided the customerdelivers such defective merchandise prepaid. Any repairs, maintenance or servicing of Richard Wolfmerchandise by anyone other than a factory authorized representative will render our warranty null andvoid.
REPAIR SHIPMENTSWhen returning your instrument for repair, we suggest that you prevent shipping damage to theinstrument by reusing the box that it was originally shipped in. Richard Wolf also recommends that theinstrument be insured for an amount to cover the cost of replacement.
IMPORTANTFor general safety and health reasons, Richard Wolf requires that you clean and sterilize all instrumentsbefore returning them for repair. If instruments are received in an unsanitary condition, Richard Wolf willclean and sterilize each instrument and add a $ 100.00 cleaning charge for each instrument requiringcleaning.
