External Coupling Micro Motor Interface standard: ISO 3964:1982

Transcription

1 OPERATING INSTRUCTIONS NOVEMBER 2015 Safety Measures The instrument will nt be delivered in sterile cnditin! Remve the instrument frm packaging befre sterilizing. The Dermatme has t be cleaned, disinfected and sterilized befre first time use and after each prcedure. T avid injury t the patient and perating staff when using the Davies Dermatme, the user must be thrughly familiar with its functin, applicatin, and instructins fr use. D nt attempt t use the equipment until all the instructins have been studied and understd. Always inspect all equipment and accessries befre use. D nt use suspect, damaged r wrn equipment. Always use eye prtectin when cutting t prevent injury frm flying debris. D nt allw lse articles t be caught by the mving parts f the equipment. Never drp the equipment, always handle with extreme care. Shuld it be inadvertently drpped r damaged, the Dermatme shuld be returned fr service. D nt use. Only clean the equipment as directed in these Instructins. ONLY use the Feather Dermatme blades with this Dermatme (Ref GF 603 Duplex Blades & GF 602 Simplex Blades). The Feather Dermatme Blades have been specifically designed and engineered fr use with the Davies Dermatme. Other blades may nt fit prperly in the Dermatme and may cause serius injury. Using ther blades may cause the Dermatme t give an incnsistent cut r t take deeper grafts than the selected thickness. Use cautin when handling the blade t avid nicking it, which may result in an uneven cut. T avid blade being damaged always place the Dermatme blade side up when nt in use. Never re use equipment marked as single use nly. Clse attentin must be paid t the Cleaning Instructins fr the Dermatme The instrument may nly be perated by trained and experienced persnnel! When used in cnjunctin with an external micr mtr: Always check that the vltage stated n the identificatin plate crrespnds with the electrical supply. D nt immerse the micr mtr in fluid. The Dermatme can be used up t max rpm! Always discnnect the equipment frm the electrical supply when cleaning, changing accessries r when nt in use. Imprper use and repair f the device as well as nt cmplying with the instructins relieve us frm any bligatins regarding guarantee r ther claims! Descriptin Davies Gld Series Dermatmes are surgical instruments fr harvesting f skin, fr grafting. They are capable f prducing grafts f between 0.08 and 0.38mm in seven thicknesses. Variances DSP 103 Duplex t Simplex reductin plate Cutting width 73mm t 48mm DMP 103 Duplex t Miniplex reductin plate Cutting width 73mm t 23mm SMP 102 Simplex t Miniplex reductin plate Cutting width 48mm t 23mm Technical Data Cutting depth: Speed: rpm External Cupling Micr Mtr Interface standard: ISO 3964:1982 Spare Parts GF 602 Blades (20 per pack) (third party supplied) Feather Simplex Blades GF 603 Blades (20 per pack) (third party supplied) Feather Duplex Blades Dcument N Revisin Page IFU-0001 G 1 f 5

2 Imprtance f Caring fr the Dermatme The Dermatme and accessries must be inspected prir t each use Visually inspect fr any damage r wear n Dermatme Always inspect the Dermatme cutting edge carefully fr pssible nicks r burrs caused by extended use r mishandling. Check that the Dermatme is running smthly, befre perating. The Davies Dermatme shuld be returned every 6 mnths if used n a regular basis r every 12 mnths if used peridically, fr calibratin and inspectin/maintenance. If damage r wear is nticed n the dermatme that may effect the functining f the Dermatme, d nt use. Cntact representative. Inspectin f Dermatme n receipt Always inspect the Davies Dermatme fr external signs f damage. Keep all packing material until the cntent has been verified and an initial peratinal check has been perfrmed. If the Dermatme is damaged, cntact the representative immediately t cme and inspect the dermatme and t prepare a reprt, the Dermatme will be returned t Davies Dermatmes fr evaluatin. Operatin System Preparatin: Inserting the Blade: Use a new sterile Feather blade fr each prcedure (GF 602/GF 603). Remve the sle plate by releasing the tw retaining screws. Lubricate the scillating blade carrier, and the tw pints shwn in Fig. 2, with ne small drp f sterile mineral il. Fit sterile Feather blade t the blade carrier ensuring it is lcated crrectly. Ensure that the Dermatme is nt cnnected t a mtr while the blade is being fitted. Lubricate the blade with sterile mineral il, replace and secure the sle plate with sle plate screws, by alternating the tightening f the sle plate screws frm left t right, left t right, until evenly tightened. Cnnecting the Mtr: Cnnect the cable and ft switch t the mtr. Insert micr mtr shaft int handle with the slt twards the tp. Gently engage the slt and the lcating pin in the handle, by rtating mtr gently with a little pressure until they align and click tgether. Cutting the graft: Skin shuld be prepared in rutine manner. Lubricate the dnr site with sterile mineral il which will help with the ease f mvement f the Davies Dermatme ver the dnr site. (At this pint it may prve useful t draw the Dermatme backwards ver the dnr site t get a gd feel f the area and t shw up any unevenness). T select the required graft thicknesses push in the knurled selectr and rtate the lever int the required slt. The nrmal setting is N 3. Fig 3 and 4. Dcument N Revisin Page IFU-0001 G 2 f 5

3 Setting Cut (mm) Cut (Inches) Fr best results, hld the Dermatme at apprx. 35 degrees when cutting. Guide the unit frward using a slight dwnward pressure t ensure that the cutting edge remains cntinuusly firmly in cntact with the dnr site. Allw the cut graft t accumulate in the angled grve f Dermatme. Lift dermatme away frm the dnr site t end graft, carefully remve the graft with tissue frceps. D nt cut fr prlnged perid withut dipping the Dermatme in sterile water, t remve debris and bld. A new blade is required fr each new prcedure. Refer t Inserting the blade sectin The sle plate is interchangeable with the reductin plates t enable the surgen t prduce smaller grafts. When using the Dermatme in cnjunctin with an external micr mtr Set cntrl unit at the desired speed ( rpm is recmmended maximum speed fr nrmal use). DO NOT EXCEED RPM Care must be taken nt t immerse the micr mtr in water. After Prcedure: Cautin: The Feather Dermatme blade is very sharp. T avid injury handle the blade with extreme care. Detach the Dermatme frm the external micr mtr. Lsen sle plate screws, remve sle plate. Remve the used blade and dispse prperly in apprpriate waste cntainer, r per hspital prtcl. Remve excess bdy fluids and debris with a dispsable, nn-shredding wipe, r wash Dermatme head under running water, and cver with a damp clth. D nt allw the Dermatme t dry while still cvered in bld and debris. Place the Dermatme, including its reductin plates, int a sterilizatin case fr transprt and cleaning. Cleaning Cmplete Dermatme Scrupulus cleaning befre sterilisatin is f greatest imprtance. The Dermatme may be placed in an autmated washer disinfectr in accrdance with UK best practice guidelines. Instruments shuld be cleaned within 30 minutes f use t minimize the ptential fr bld and debris t dry n the Dermatme prir t cleaning. Always wear utility glves, a mask, and eye prtectin when cleaning instruments. Handle the Dermatme with care. Shuld the dermatme be drpped r damaged, it shuld be returned fr service. Take care while remving the blade. Safely dispse f all used blades in an apprpriate waste cntainer, r in accrdance with hspital plicy. Universal precautins fr handling cntaminated/bi hazardus materials shuld be bserved. If desired, a pre-sak in a neutral ph enzyme slutin may be used prir t scrubbing with a detergent. Prepare a ph neutral detergent slutin at the use-dilutin and temperature recmmended by the manufacturer. Thrughly scrub the instrument with a sft-bristled brush using the detergent slutin. Pay attentin t any crevices and ther hard t reach areas until all visible sil has been remved. D nt use abrasive materials that scratch r pit instruments. D nt use hand sap t clean instruments because fatty acids in the sap react with hard water t leave a sap scum n the instruments. Please change cleaning slutin if it becmes grssly cntaminated with bld and debris. The indicatr rd shuld be turned while cleaning t release any debris which culd be trapped under the lever r in the ntches. Always rinse thrughly with clean, flwing water until n mre bld r sil is present. Dry the instrument with a clean, dispsable, absrbent, nn-shredding wipe. Carefully inspect each instrument t ensure that all visible bld and debris has been remved. Dcument N Revisin Page IFU-0001 G 3 f 5

4 Inspect the Dermatme fr damage and wear. Check that the adjustment knb wrks smthly. Sterilisatin Vacuum steam sterilisatin is the mst effective methd, and is the nly recmmended methd t sterilise the Davies Dermatme. Make use f a saturated steam with active air remval mist heat sterilisatin autclave, which has been validated in accrdance t ISO :2006. Ethylene xide sterilizatin is nt recmmended fr the Davies Dermatme. Place the cleaned instrument in a sterilizatin case. The Davies Dermatme sterilizatin case is recmmended. Vacuum steam autclave fr 3 t C C with a Drying cycle and cled dwn naturally. D nt immerse in liquid t cl. Cl by expsure t rm temperature r cver with a cld, sterile twel. Lcal r natinal specificatins shuld be fllwed when steam sterilizatin requirements are stricter r mre cnservative. Equipment must be sterilised befre: Every prcedure. Befre passing t a service area. Befre returning t the supplier r manufacturer. Dermatme Assembly T fit the handle t the Dermatme head: Insert the drive bush int the slt in the Dermatme head. Carefully slip the handle int the Dermatme head, ensuring that the drive spindle is lcated int the drive bush (yu can use the multi spanner (flat side) t help guide the spindle int the drive bush). Secure with handle retaining screw. Fault Finding FAULT POSSIBLE CAUSE REMEDY Instrument des nt run, r runs Blade jamming (check rtatin f Check that the blade is psitined slwly spindle using rear f hex driver. prperly n blade carrier studs. Mtr runs instrument but blade des nt scillate, r nly partially Difficulty in adjusting cutting height Difficulty in cutting skin Repair and service infrmatin Blade jamming between cutting head and sle plate due t damage. Blade jamming due t dried bld and debris. Drive bush wrn r split the drive bush is cnsidered t be a cnsumable part. Height adjuster bent. Damaged r wrn blade new blade shuld be used fr each prcedure (ensure yu use the Feather blade which is made especially fr this instrument). Return t service centre fr inspectin and repair. Clean Dermatme well with a ph neutral Detergent. Replace drive bush. (Part N. DSG 170) Return instrument t service centre fr inspectin and repair. Replace Blade. All Davies Dermatmes shuld be peridically checked and cleaned. The instrument shuld be calibrated and serviced nce every six mnths if used daily, and nce a year if used peridically. Due t the specialist techniques used in the manufacture f the Davies Dermatmes the instrument shuld be returned t ur appinted and apprved service centres. Warranty & Liability Davies Dermatmes warrants that the Davies Dermatme, alng with all parts and accessries, have been tested and inspected, and have left the factry in prper wrking cnditin, free frm visible defects. Dcument N Revisin Page IFU-0001 G 4 f 5

5 Davies Dermatmes warrants their prducts against all defects appearing within 12 mnths f the date f Invice, which are directly attributable t faulty materials r defective wrkmanship nly. This guarantee des nt apply t parts which becme wrn as a result f nrmal wear and tear r any damage arising as a result f faulty r unauthrized maintenance. Subject t the abve, defective items will be replaced r repaired (at the discretin f Davies Dermatmes) free f charge if returned within the Guarantee perid t Davies Dermatmes r it s authrized distributr tgether with the riginal invice. Davies Dermatmes is nt liable by warranty r therwise in the case f any f the fllwing Abuse, misuse r use in ther than the designed purpse. Disassembly, alteratin r unauthrized repair. If the prduct has nt been used in a reasnable manner and in cmpliance with the written instructins. The abve instructins were validated by Davies Dermatmes as being suitable fr preparing a medical device t be reused. The preparer is respnsible fr ensuring that the actually perfrmed preparatin invlving the equipment, materials and persnnel used in the preparatin facility achieves the desired results. This nrmally requires validatins n rutine mnitring f the prcedure. Likewise each deviatin frm the prvided instructins shuld be carefully analysed fr its effect and ptential detrimental cnsequences. If yu require service, repairs r replacement parts, please cntact the dealer r representative fr yur cuntry. ONLY GENUINE DAVIES DERMATOME PARTS MAY BE USED IN THIS DEVICE DISPOSAL: When dispsing f the device, device parts and accessries, the enacted requirements specified in legislatin must be fllwed. Manufacturer: Davies Dermatmes cc, 5 Amanzi Crescent, Vredeklf, Brackenfell, 7537, Cape Twn, Suth Africa Tel: Authrized Representative in Eurpe: Emerg Eurpe, Mlenstraat 15, 2513 BH The Hague, The Netherlands Dcument N Revisin Page IFU-0001 G 5 f 5