Operating Instructions SURGICAL POWER & ACCESSORIES

Transcription

1 SURGICAL POWER & ACCESSORIES

2 Table of Cotets PAGE 2 PAGE 3-5 PAGE 6 Itroductio Warig Traiig Setup Illustratio Drill Motor Setup Quick Coectors Motor / Foot Cotrol Coectios Attachmet Istallatio Straight & Agled Cutter Istallatio Straight Attachmets Cutter Istallatio Agled Attachmets Craiotome Cutter & Attachmet Istallatio Attachmets Straight, Agled & Craiotome Attachmets PAGE 7 Cutter Compatibility Straight & Agled Attachmets / Cutters Craiotome Attachmets / Cutters 1 PAGE 8-9 Drill Motor Operatio / Recommedatios Specificatios Drill Motor Operatio Cautios PAGE 10 Cleaig, Maiteace & Lubricatio Drill Motor Nosepiece Attachmets Drill Motor Hose, Air Hose & Foot Cotrol PAGE 11 Sterilizatio Guidelies PAGE 12 Troubleshootig PAGE 13 Compoets & Accessories PAGE 14 Service ad Warraty

3 Itroductio WARNING Make sure to read ad uderstad this Istructio Maual thoroughly before usig the Tava Surgical. Do ot use this system uless you have traiig ad experiece usig high-speed surgical istrumets. Traiig Prior to usig the Tava Surgical High Speed Drill Motor System it is essetial that all idividuals who will use or hadle the system uderstad this Istructio Maual ad all aspects of usig this system. We recommed that surgeos ad hospital staff have i-service traiig by a authorized Tava Surgical Represetative before usig this Drill Motor System. The surgeo is ultimately resposible for learig ad uderstadig proper High Speed Drill Motor System use. Failure to do so may cause ijury to the patiet, hospital staff or surgeo. Extra cautio must be observed whe usig the Drill Motor System aroud eural ad vascular areas. Setup Illustratio Foot Cotrol Side View 2 Nosepiece Attachmet Air Supply Hose Coectors ( female ) Foot Cotrol Coectors ( male ) Air / Nitroge Supply Foot Cotrol Coectors ( female ) Motor ( female ) Foot Cotrol Air Supply Hose ( male ) Air Supply Hose Coectors ( male )

4 Drill Motor Setup Quick Coectors The is desiged with quick-coect compoets for easy assembly. No special tools or fittigs are required to assemble or operate the system. All hose, foot cotrol ad motor coectios ca be coected oly oe way. Each fittig has a male (Fig. 1) or female (Fig. 2) coector. Fittigs are coected by first aligig the pis o the male coector with the slots of the female coector. Slide the pis ito the slots ad press the two coectors together slightly. Twist the male coector util the pis rotate to the locked positio (Fig. 3). Fig. 3 Fig. 1 Fig. 2 3 Motor / Foot Cotrol Coectios Motor Hose to Drill Motor Coect the motor hose (male) to the drill motor (female) (Fig. 4). < Foot Cotrol Coectors > Fig. 5 Fig. 6 Motor Hose to Foot Cotrol Coect the motor hose (female) to the foot cotrol (male) (Fig. 5). Supply Hose to Foot Cotrol Coect the supply hose (male) to the foot cotrol (female) (Fig. 6). Fig. 4 Supply Hose to Wall / Tak Coect the supply hose to the wall / tak itroge or sterile air supply (For Schrader use MI-121 ad for DISS use MI-121DISS).

5 Drill Motor Setup Attachmet Istallatio Straight & Agled All attachmets lock securely i place without special tools. Agled Attachmet Both Straight ad Agled Attachmets Before istallig the agled attachmet, rotate Make sure the collar o the attachmet is rotated the drill motor s collar to the BUR LOCKED / fully i the ope positio. Positio attachmet MOTOR ON positio. This is ecessary to allow over the drill motor ad push together getly the agled attachmet s drive mechaism to util the attachmet is seated fully o the drill egage the motor drive properly. motor (Fig. 7). If eeded, rotate slightly to seat. Had tighte the collar to the closed positio (Fig. 8). Collar Fig. 7 Motor Collar Closed 4 U-locked - Motor Off Fig. 8 Cutter Istallatio Straight Attachmets For straight attachmets, rotate the motor collar to the BUR UNLOCKED / MOTOR OFF positio. Isert the cutter through the attachmet, ito the drill motor ad rotate bur util it seats i place. Twist collar to the BUR LOCKED / MOTOR ON positio (Fig. 9). TUG Fig. 9 Importat: Tug slightly o bur to esure it is fully locked i-place.

6 Drill Motor Setup Cutter Istallatio - Agled Attachmets For agled attachmets rotate the attachmet s collar to the BUR UNLOCKED / MOTOR OFF positio. Isert the cutter ito the attachmet ad rotate bur util it seats i place. Twist the attachmet collar to the BUR LOCKED / MOTOR ON positio. Also, positio the motor collar to the BUR LOCKED / MOTOR ON positio to ulock the drill motor (Fig 10). Attachmet Collar Importat: Tug slightly o bur to esure it is fully locked i place. Note: Whe usig a agled attachmet, the motor collar also must be i the BUR LOCKED / MOTOR ON positio i order for the motor to rotate. TUG Fig. 10 U-locked - Motor Off 5 Craiotome Cutter ad Attachmet Istallatio For Craiotome attachmets rotate the motor Make sure the collar o the craiotome collar to the BUR UNLOCKED / MOTOR OFF attachmet is rotated fully i the ope positio. positio. Isert the cutter directly ito the motor ad rotate util it seats i place. Twist collar to the BUR LOCKED / MOTOR ON positio (Fig. 11). Positio the correspodig craiotome attachmet over the cutter ad push together getly util the craiotome attachmet is seated securely o the motor. If eeded, rotate slightly to seat. Had tighte the collar clockwise to the closed positio (Fig. 13). Cautio: Do ot attempt to rotate collar of the drill ad / or collar of the attachmets ito ope positio while operatig the motor. Fig. 11 Importat: Tug slightly o cutter to esure it is fully locked i-place. TUG Fig. 13

7 Attachmets Straight, Agled & Craiotome Attachmets All attachmets lock securely ito place without special tools. The osepiece attachmets come i three mai groups: Straight, Agled ad Craiotomes (Fig. 14, 15 ad 16). 90mm 70mm 50mm 110mm There are four sizes each of straight ad agled attachmets i 50, 70, 90 ad 110 mm legths ad two sizes of Craiotomes, 12 ad 16 mm. Istall attachmets as outlied i the drill motor setup sectio. 16mm 12mm 6 Fig. 14 STRAIGHT ATTACHMENTS Fig. 16 CRANIOTOME ATTACHMENTS 110mm 90mm 50mm 70mm Fig. 15 ANGLED ATTACHMENTS

8 Cutter Compatibility Straight & Agled Attachmets / Cutters Each group of osepiece attachmets (Short 50 mm, Medium 70 mm, Log 90 mm, Extra Log 110 mm) is desiged to operate with a wide rage of dissectig cutters. Straight ad agled attachmets of 50, 70, 90 ad 110 mm legths must be used with 50, 70, 90, 110 mm legth cutters respectively. Example: Cutter Item umber S30RDX idicates the followig: S = 50 mm attachmet 30= 3.0 mm head diameter R = Roud head shape D = Diamod head type X = Extra Coarse S 30 R D X Attachmet Head Diameter Head Shape Head Type Coarseess or Grit 7 S = 50 mm M=70 mm L = 90 mm X = 110 mm 06 = 0.6 mm 10 = 1.0 mm 20 = 2.0 mm 30 = 3.0 mm 40 = 4.0 mm 50 = 5.0 mm 60 = 6.0 mm 70 = 7.0 mm 90 = 9.0 mm R = Roud M = Match Head A = Acor PC= Pi Cutter F = Fluted D = Diamod F = Fie M = Medium C = Coarse X = Extra Coarse IMPORTANT: Each legth cutter must be used oly with the correspodig matchig osepiece attachmet. Craiotome Attachmets / Cutters Each Craiotome attachmet must be used oly with its correspodig size cutter. Size Pediatric Adult Craiotome Attachmet XKP-C12 XKP-C16 Craiotome Cutter CF12S CF16S

9 Drill Motor Operatio / Recommedatios The motor s high speed eables the operator to cut boe, plastic ad metal rapidly. The differet legths of straight ad agled osepiece attachmets allow access to differet aatomical structures. The rage of cutters offered allows for a wide rage of procedures. SPECIFICATIONS Power Compressed itroge or sterile air Pressure Supply 120 psi 130 psi for optimal performace ( Bar) Drill Motor Speed 100,000 RPM (90,000 to 105,000) Drill Motor Legth 110 mm Drill Motor Diameter 15.0 mm Sterilizatio Complete system ca be washed ad autoclaved (See Sterilizatio Guidelies) Cautio: Never exceed air pressure of 150 psi (10.3 Bar) as this may cause the motor to fail. Drill Motor Operatio Please ote the followig operatioal ad safety tips: 1. The drill should be held like a dissector for precise cuttig ad better figertip feedback (Fig. 17). 2. Always irrigate thoroughly whe cuttig to avoid boe heatig. 3. Cut oly what you ca see. 4. Never use osepiece to bed or pry. 5. Always wear safety glasses ad protective clothig. 6. Always use appropriate legth attachmet with chose bur legth. 8 IMPORTANT Very light pressure is required o the cuttig tips. Do ot exert excessive pressure o the cutter tips. The high-speed drill ad istrumets are desiged to do the cuttig. Guide the drill with your figertips usig a smooth tappig or circular motio. Fig. 17

10 Drill Motor Operatio / Recommedatios Cautio: Tava Surgical equipmet is desiged for use oly by medical professioals who are completely familiar with the applicable surgical techiques ad istructios for the use of the equipmet. Prior to each use, all istrumets ad accessories must be ispected for proper operatio. To assure safety of the patiet ad operatig persoel, use oly Tava Surgical accessories ad attachmets. Always ispect air hoses prior to use. Wor or damaged hoses should ot be used but retured to Tava Surgical for repair/replacemet immediately. Never use cleaig solutios o drill motor without hose attached. See Cleaig, Maiteace & Lubricatio. Always lubricate motor before sterilizatio. Always wear safety glasses ad protective clothig while operatig the motor. Do ot force cutters. Allow the istrumet to do the cuttig. Do ot use attachmets for pryig or bedig. Do ot use istrumets i a site that is ot visible. 9 Do ot activate foot cotrol while maipulatig attachmets or cutters. Udue pressure ad isufficiet irrigatio may cause premature cutter damage ad overheat or damage the boe. Whe a bur is locked ito drill collet, ever operate drill without proper attachmet istalled.

11 Cleaig, Maiteace ad Lubricatio After each use ad prior to sterilizatio, the drill ad all compoets should be cleaed with a mild, o-abrasive, eutral PH cleaig solutio. Drill Motor Keep motor hose attached to the motor ad clea the motor ad hose getly with a mild cleaig solutio. Use a small brush to clear all debris. Rise with fresh water ad wipe dow with damp cloth. Apply 1-2 shots of Tava Surgical aerosol lubricat ito the air itake ed of the drill motor. Recoect hose ad ru drill for 5-10 secods before sterilizig (Fig. 18). Wipe off excess lubricatio. Importat: After each use, be sure to lubricate as metioed above before sterilizatio. Failure to do so may damage the motor ad void the warraty. Fig. 18 Motor Nosepiece Attachmets Clea the osepiece attachmets getly with a mild cleaig solutio. Rise with fresh water ad clea with pipe cleaer or bottle brush. Remove all debris from attachmets, iside ad out. Pipe cleaers or bottle brushes may be used o straight attachmets ad craiotomes ONLY! Do ot use cotto swabs. 10 Drill Motor Hose (from foot cotrol to motor) Rise with fresh water ad wipe dow with damp cloth to remove ay debris. Sterilize after each use. Air Hose (from foot cotrol to air supply) Rise with fresh water ad wipe dow with damp cloth to remove ay debris. Sterilize after each use. Foot Cotrol Rise with fresh water ad wipe dow with damp cloth to remove ay debris. Sterilize if required, but ot recommeded. CAUTION: Never clea i ultrasoic washer. Never immerse motor or attachmets. Automatic Washers / Disifectors Cosult a Tava Surgical represetative prior to placig ay Tava Surgical XK- Pro100 motor or accessory ito a automatic washer or disifector.

12 Sterilizatio Guidelies The sterilizatio of devices is ultimately determied by the members of the hospital staff i cojuctio with pathology advisors. These suggestios regardig sterilizatio are oly guidelies ad may be varied from hospital to hospital, depedig upo the type of sterilizatio equipmet ad possible pathoges i that particular area. The followig methods of sterilizatio have bee validated for the Tava Surgical High Speed Drill Motor, attachmets ad hoses: Sterilizatio Type: Gravity Miimum Temperature: 132 C (260.6 F) Full Cycle Time: 20 Miutes Miimum Dry Time: 0 Miutes Cofiguratio: Wrapped Tray Sterilizatio Type: Gravity Miimum Temperature: 132 C (260.6 F) Full Cycle Time: 15 Miutes Miimum Dry Time: 0 Miutes Cofiguratio: Uwrapped Tray 11 Sterilizatio Type: Pre-Vacuum Precoditio Pulses: 3 Miimum Temperature: 132 C (260.6 F) Full Cycle Time: 4 Miutes Miimum Dry Time: 0 Miutes Cofiguratio: Wrapped Tray Gas sterilizatio (Ethylee Oxide) is NOT recommeded for the system ad compoets. Importat: Use deioized water durig sterilizatio to miimize buildup of iteral deposits.

13 Troubleshootig Symptom Potetial Cause Solutio Drill motor does ot Iadequate lubricatio. Lubricate per maiteace rotate or spis slowly. requiremets. Retur for service if eeded. Low itroge / sterile air pressure. Pressure to be PSI (8.4 to 9.1 BAR). Hose may ot be coected Check coectios betwee motor properly. ad foot cotrol ad betwee the foot cotrol ad air supply. Check for kiks. Wor or damaged compoets. Retur for service. High or abormal vibratio. Damaged or bet bur. Replace with a ew a Tava Surgical cutter. Wrog attachmet / bur Use proper attachmet for combiatio. selected bur. Wor attachmet bearigs. Retur for service. Drill / attachmet dropped. Retur for service. High or abormal oise. Iadequate lubricatio of Lubricate per maiteace drill. requiremets. Damaged or tor air hose. Order replacemet. Drill or attachmet bearig wor. Retur for service. Drill motor overheatig. Drill used immediately after Allow drill to cool before usig. steam sterilizatio. Wor / damaged bearigs Retur for service. or compoets. Iadequate lubricatio. Lubricate per maiteace requiremets. Excessive lubricatio. Lubricate per maiteace requiremets. Attachmets overheatig. Wor / damaged bearigs Retur for service. or compoets. 12 Difficulty coectig hoses. Bet or damaged coectors. Retur for service / replacemet. Cutters will ot fit ad / or Debris i collet assembly. Clea per maiteace ot secure. requiremets. Not Tava Surgical cutters. Replace cutters. Damaged collet assembly. Retur for service. Black surface fadig. Strog or abrasive cleaer used. Use mild, o-abrasive cleaer.

14 Compoets & Accessories Warraty XKP-100A Drill Motor XKP-110 Drill Motor Hose (Motor to Foot Cotrol) MI-121 Air Supply Hose Schrader MI-121DISS Air Supply Hose DISS MI-151 Foot Cotrol NOSEPIECE ATTACHMENTS XKP-S50S Straight, Small, 50 mm XKP-M70S Straight, Medium, 70 mm XKP-L90S Straight, Log, 90 mm XKP-X110S Straight, Extra Log, 110 mm XKP-S50A Agled, Small, 50 mm XKP-M70A Agled, Medium, 70 mm XKP-L90A Agled, Log, 90 mm Tava Surgical warrats all istrumets to be free from defects i material ad workmaship for a period of oe (1) year from the origial purchase date. Tava Surgical air hoses ad accessories are warrated for six (6) moths from the origial purchase date. The warraty is limited to the repair of the product without charge. Burs ad saw blades are warrated to be free from defects upo delivery. This warraty is void i the evet of ay of the followig: Abuse, misuse or use i other tha ormal surgery eviromet, disassembly, alteratio or uauthorized repair, or i the evet that the product has ot bee used i reasoable maer ad i compliace with the writte istructios furished by Tava Surgical. XKP-X110A Agled, Extra Log, 110 mm The system ad CRANIOTOMES compoets (motor, attachmets, hoses ad foot cotrol) ca oly be retured for XKP-C12 Pediatric, 12 mm repairs. XKP-C16 ACCESSORIES Adult, 16 mm Repair Service 13 MI-191 XKP-192 XKP-188 MI-104 XKP-111 Aerosol Lubricat Lubricat Adapter Sterilizatio Case Trepa Motor Trepa Motor Adapter (Required whe usig the XKP-110) Tava Surgical recommeds that powered devices be retured for prevetive maitace every twelve (12) moths, ad powered device accessories be retured for prevetive maiteace every six (6) moths. Tava Surgical warrats ay service or repair work performed will be free from defects i material or workmaship for the period of 6 (six) moths from date of service or repair of istrumets. This warraty applies to the actual work performed. Please cotact your Tava Surgical Distributor for istructios o returig equipmet for repair. Whe returig equipmet for repairs it is the customer s resposibility to decotamiate ad sterilize the product. Upo request, loaer istrumets ca besupplied, depedig o availability of stock. Note: The istrumets received from Tava Surgical or its authorized represetatives, ew istrumets, loaer istrumets or istrumets retured from service / repair must be sterilized by the facility they are delivered to, prior to use.

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16 SURGICAL POWER & ACCESSORIES Schipholweg PL Badhoevedorp - the Netherlads Ph All rights of distributio, also by photocopy, reprit or storig ad recovery i ay kid of data processig are reserved ad require our writte approval.