User manual MEEK (English)
Contents
1. 10 Cutting aid The cutting aid fig 8 is used to as a ruler to cut the graft on the cork plate When the cutting aid is placed and centered on top of the graft on the cork plate and the graft is cut alongside the edges of the cutting aid the size of the graft will be 41x41 mm 1 61x1 61 which is just a little smaller than the cork plate itself thus preventing the graft to overhang the edges of the cork plate 46 Material anodised aluminium Weight 21 gram 0 74 oz Dimensions 41x41x24 mm 1 61x1 61 Ji Ordering number 3 CA01 Fig 8 Cutting aid 11 Sterile oil The MEEK machine has to be lubricated every now and then Humeca supplies STERILIT oil for this purpose This oil is applied prior to sterilization The oil is validated for steam sterilization methods according to EN 554 ISO13683 as well as for dry heat heated air sterilization up to a temperature of 180 C 356 F The oil is supplied in a bottle of 50 ml 1 7 fl oz Ordering number is 2 JG598 12 Gearwheels set If desired MEEK cutting machines can be provided with gearwheels in order to speed up the pence movement of the cutting block gt The gearwheels are mounted at Ss the hand wheel side of the ee machine see fig 9 i mainam On request machines without gearwheels can be provided with the gearwheel set later on Material stainless steel Fig 9 MEEK machine with gearwheels Transmission ratio 1 2 52. Q 3 humeca MEEK Micrografting Instructions for use and installation Technical data Cylindrical motor and hand drive IFU MEEK 14 03 MEEK cutting machine C MEEK prefolded gauzes C 0344 General remark This manual describes how the MEEK technique is performed in text and pictures For a better understanding of the procedure we strongly advise you to watch the MEEK instruction films that come on a DVD with each machine These films clearly show the MEEK procedure from assembly of the machine until healing of the burn wound NOTE The videos about the MEEK procedure and handling of the equipment are also available from the Humeca website www humeca com section MEEK Micrograft submenu videos You can also scan one of the codes below MEEK instructions MEEK surgery Warning Always pay attention to the presence of very sharp blades in the MEEK machine Please handle them with care to prevent cutting accidents Contents SECTIONI INSTRUCTIONS FOR USE AND INSTALLATION I Mounting and dismounting the machine 1 Assembly of the machine 1a Placing the pneumatic motor 1b Connecting the air hoses for pneumatic drive 1c Placing the hand drive 2 Lubrication 3 Sterilization and cleaning 3a Preparing before cleaning and sterilization 3b Cleaning and sterilization procedure I The Micrograft procedure 1 Determining the expansion factor 2 Harvesting the graft 3 Preparing
3. Ordering number 3 GWS 47 Supplier Humeca BV P O Box 40175 Het Bijvank 251 a 7504 RD Enschede 7544 DB Enschede The Netherlands The Netherlands Phone 31 53 4762619 Fax 31 53 4771905 E mail info humeca com Web www humeca com Humeca is an EN ISO 13485 2003 certified company NOTE Video movies about the MEEK procedure and handling of the equipment are available from the Humeca website www humeca com section MEEK Micrograft submenu videos You can also scan one of the codes below MEEK instructions MEEK surgery
4. a longer drying time after pressing the cork y ng g does not harm When much was too short l plate to the gauze and glue was applied the drying removing it the graft is time should be increased still on the cork plate Use water or physical salt instead of sticking to A fatty substance like solution when harvesting the the prefolded gauze paraffin oil was used skin but at no means use oil during harvesting of the Oil prevents the glue from skin to establish easy sticking If accidentally oil was run of the dermatome used try to clean the epidermal side of the graft with alcohol After unfolding the than the cork plate the size of the cork plate gauze the graft islands See section Skin is not cut do not separate complete above properly a significant Far too much glue was number of islands ora used The glue complete row remains penetrated in the seems unseparated when between the graft unfolding the gauze islands and stuck them together Condition of the wound bed was insufficient for Use less glue Try to improve wound quality by grafting for instance additional treatment before re infected areas grafting Graft take 2 Ow nany Wait for grafting until later stage graft islands finally patient was insufficient disappeared Attention the glue has to be Grafts were placed on applied to the epidermal side of the wound epidermal the grafts This means the side down dermal side of the grafts has to face the c
5. authorized personnel The motor is placed in the casing in such a way that the cam 22a comes in the groove of the casing as shown in fig 4 and 5 Now place the casing with the motor inside on the machine and push the coupling hull 15a of the motor over the coupling hub 15 of the blades axis fig 6 See to it that the casing 3 fits precisely in the groove 14 of the bridge The hole 3a in the cylindrical wall of the casing should be at the upper side fig 7 Close the clamp 10 The cam 10a of the clamp should come into the 5 hole 3a of the casing wall fig 8 If clamp 10 cannot be closed either the hole 3a is not in the right position or the casing 3 is not pushed into the groove 14 of the bridge After closing clamp 10 fasten motor bolt 9 fig 9 push and turn a quarter The motor is taken off by acting the other way round Attention Beware that the motor doesn t fall out of the casing 1b Connecting the air hoses for pneumatic drive The procedure is illustrated in fig 10 14 The foot pedal has two connections fig 10 One air hose is already fastened to the pedal Connect the other end of that hose to the motor inlet 22b by pushing the quick connector 8 over it fig 11 and 12 Because there is a large variety in hose diameters and connectors in use internationally we cannot supply the air hose between the foot pedal and the pressure system in the operating room Please arrange a suitable hose for that purpose yourself
6. no motor was requested Weight of a hand drive is 0 195 kg 6 9 02 7 Pneumatic motor and housing The motor is a stainless steel compact vane air motor Recommended pressure 4 8 bar 58 116 psi lt is recommended to use a 5 micron air filter in the air supply The motor is supplied with a sound reducer Weight 1 1 kg 2 44 Ib Technical data at a pressure of 6 bar 87 psi Power 270 Watts Max rom 710 rpm Rotation Counter clockwise Air consumption 0 5 m min 110 gal min Gear ration 25 Ordering number of the cylindrical motor is 3 087 The motor is incorporated in a tube made out of anodized aluminium Ordering number of this housing is 3 088 45 8 Foot pedal The motor is switched on and off by means of a pneumatic foot pedal The pedal has one air inlet and one air outlet Technical data Material Cast iron steel Operating pressure 2 8 bar 29 116 psi Flow rate at 6 bar 87 psi 950 l min 210 gal min Weight 0 7 kg 1 56 Ib Port size G 1 4 Dimensions Ixwxh 193x83x70 7 6x3 3x2 8 Ordering number of the foot pedal is 3 CP4 9 Serrated wedge The serrated wedge fig 7 also called cam is used whenever the graft of the patient adheres to the cover of the cutting block at opening a Material anodized aluminium De eS Weight 77 gram 2 72 02 Sree Dimensions 45x38x30 mm RA oy 1 77x1 50x1 18 os Ordering number 3 SW01 Fig 7 Serrated wedge or cam
7. cork holder anodised aluminium single grating cover anodised aluminium locking pin st steel spring D21760 st steel locking handle st steel OONOOOBRWDND Weight of a single cutting block is 0 297 kg 10 5 oz 5b Double cutting block Fig 5 Double cutting block 43 Major parts of the double cutting block are the same as for the single cutting block with the exception of the base plate the grating cover and the springs The details of these parts are as follows No in Ordering fig 5 no 02053 double base plate L anodised aluminium 000201 double grating cover anodised aluminium 0106 spring D21960 st steel Description Material Weight of a double block is 0 332 11 7 oz The function of the cutting blocks is to keep the graft in place during cutting 6 Hand drive set The hand drive set is shown in fig 6 below Fig 6 Hand drive set 44 The hand drive set consists of Ordering Ao Description Material drive axis st steel locking cylinder nylon coupling shell 10 nylon hex socket set screw DIN916 M4x5 N st steel pin st steel screw ULF M4x16 A2 70 st steel one way runner anodised aluminium lever anodised aluminium ring brass turning knob anodised aluminium turning knob axis st steel DIN912 M5x12 12C st steel The function of the hand drive set is to drive the blades axis in case the motor is not working or no pressurized air is available or
8. motor and housing see section 7 If motor driven foot pedal see section 8 Serrated wedge or cam see section 9 Cutting aid see section 10 Sterile oil see section 11 Optional gearwheels set see section 12 Pneumatic connectors and hose clamps Each of these components will be described in detail in the following sections 38 O Fig 1 The MEEK cutting machine in exploded view 39 3 Main frame The main frame consists of No in Ordering fig 1 no Description Material bottom plate anodised aluminium bridge stand anodised aluminium motor stand anodised aluminium anodised aluminium bronze bearing axis stand rear anodised aluminium bronze bearing hand wheel fig 2 see separate section below spindle st steel ceramic coating guiding axis L st steel guiding axis R st steel bridge anodised aluminium st steel axis stand front OONOO A WN oO Hand wheel The hand wheel is shown in the picture below Fig 2 The hand wheel 40 The hand wheel consists of No in Ordering ne Description Material hand wheel anodised aluminium turning knob axis st steel turning knob anodised aluminium ring brass DIN915 M4x6 N hexagon socket set screw DIN912 M5x16 16C hex socket head cap screw st steel st steel All additional screws of the frame are made out of A2 stainless steel The function of the main frame is to support the blades axis and the c
9. 33 The central pleated area of a gauze Fig 34 The graft fixed to the gauze after removal of the cork plate a4 Like b Sha 7P gt a ae ie aires es Bis Ba k j afi a0 73559 beeli a J y St a aal U a i oily SE a a a m M i WAS va Fig 36 The gauze with grafts after extension in both directions 33 Fig 37 The extended gauze with graft islands is fixed to the wound with staples Fig 38 MEEK gauzes on a wound adjacent to each other Fig 39 A gauze with grafts is cut into smaller peaces to graft smaller areas Fig 40 Gauzes are being removed on the 6 day post grafting 35 Fig 41 Result of burn treatment by MEEK technique on the back of a patient shortly after complete epithelialization SECTION II TECHNICAL DATA 36 37 1 Introduction This section provides technical data of the MEEK cutting machine and disposables Exploded view presentations of separated parts are presented This allows the user to replace parts and service the machine independently Material data ordering numbers and functions of major parts are given 2 The MEEK cutting machine and its accessories The MEEK cutting machine consists of the following major parts and accessories Main frame see section 3 Blades axis see section 4 Cutting block single double see section 5 If hand driven hand drive set see section 6 If motor driven pneumatic
10. ETERS Gele pE Minimum Minimum l temperature dry time Prevacuum 134 C Pulsating vacuum 273 F 3 min 3 min Prevacuum 132 C Pulsating vacuum 7 270 F 4min 4 min N Prevacuum 134 C lemn Emn Pulsating vacuum 273 F Prevacuum 132 C l 1 Minimum validated steam sterilization time required to achieve a 10 assurance level SAL 2 Minimum validated steam sterilization temperature required to achieve a10 assurance level SAL 3 Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed here 4 Disinfection steam sterilization parameters recommended by the World Health Organization WHO for reprocessing instruments where there is concern regarding TSE CJD contamination 5 For universal instrument cases without defined load configurations 6 AAM AORN steam sterilization cycles with longer times than those listed are also acceptable 7 Medical grade steam sterilization compatible wrap equivalent to four thicknesses of 140 thread count muslin Rigid sterilization container that complies with ANSI AAMI ST 46 Flash unwrapped sterilization by exposure at 132 C 270 F should only be used as an emergency procedure Instruments should be cleaned 10 Drying times vary according to load size and should be increased for larger loads 8 9 Note The sterilizer Manufacturer s Instructions for operation and load config
11. We re happy to assist you if necessary It is also possible to use an air cylinder instead of the wall outlet Connect the hose from your pressure system to the other connection of the pedal by means of quick connector 24 see fig 13 This quick connector is fixed to the hose with a hose clamp Connector and hose clamps of different sizes are supplied with the machine See fig 14 for instruction A pressure of about 6 bar 87 psi is advised Do not exceed 8 bar 116 psi The apparatus is now ready for use 1c Placing the hand drive The procedure for placing the hand drive is illustrated in fig 15 17 Place the coupling hull 15a of the hand drive over the coupling hub 15 of the blades axis and place the white polymer disk 20 in the opened cylindrical support fig 15 The hole 20a in the disk should be at the upper side When closing clamp 10 the cam 10a should come into the hole of the disk fig 16 Fasten bolt 9 push and turn a quarter fig 17 2 Lubrication To grease the bearings of the blades axis and spindle we recommend to put a drop of oil into the holes indicated with a red circle in fig 19 Also put a drop of oil on the half nut at the underside 6 of the cutting block fig 18 In case of pneumatic drive we also advise to put a drop of oil into the inlet of the motor once every 3 months Humeca supplies Aesculap STERILIT oil for that purpose 3 Sterilization and cleaning 3 1 Preparing before cleaning and steril
12. ase of extensive burns Attention The autograft should be trimmed to the size of the cork plate It should not be larger than the cork plate 4 Placing the cork with the graft into the cutting block Place the cork square on the cork holder 18 and put it in the recess of the bottom of the cutting block fig 25 Moisten the underside of the cover with water or buffered salt solution to prevent sticking of the graft to the cover after cutting Close the cover and lock with bolts 19 see fig 26 12 5 Cutting 5a The first cutting Place the cutting block on the guiding axes of the cutting machine at the side of the hand wheel fig 27 This can only be done in one way because the guiding axes differ in diameter In case pneumatic drive is used Switch on the motor with the foot pedal and turn the hand wheel The cutting block is now moved under the bridge where the rotating 13 blades cut the graft into 14 stripes In case hand drive is used Turn the handle of the hand drive clockwise while someone else turns the hand wheel to move the cutting block under the bridge Attention Always move the cutting block from the side of the hand wheel to the other side never reverse fig 27 When the cutting block has reached the end of the guiding axes it can easily be taken off from the machine Open the bolts 19 and place the serrated wedge 17 in the middle of the grating in the cover fig 28 Now push the serrated wedge
13. downwards while lifting up the cover a little fig 29 Open the cover fig 30 The graft should remain on the cork plate In case a double cutting block fig 31 is used the serrated wedge is pressed into both gratings before opening the cover 5b The second cutting Turn the cork holder 18 a quarter and put it back in the cutting block Moisten the underside of the cover again close it and lock it Put the cutting block on the guiding axes at the side of the hand wheel once again and switch on the motor or start turning the hand drive Now the cutting block is passed under the bridge once more and the graft is cut into 14x14 196 squares Open the cutting block using the serrated wedge as mentioned before to prevent sticking of the graft to the cover and take out the cork plate with the graft shown in fig 32 13 6 Applying adhesive to the autograft Place the cork square with the cut autograft on a flat surface covered with a sterile cloth or some other disposable material Spray glue on the epidermal side of the graft from a distance of about 25 cm 10 inches and allow to dry for at least 6 minutes the surface must change from glossy to dull A longer drying time does not harm Attention Allow the glue to dry for at least 6 minutes some more drying time is even better Don t spray more glue than necessary to make the surface of the graft glossy Excess quantities of glue require longer drying time 7 Tra
14. eck if the coupling on the motor is running try to stop the coupling by hand while the motor is running this should not be possible If the coupling is loose fasten the screw in the coupling or if the screw is missing order a new one Screws at the end of the guiding axes are loose Humeca has to re position the or for some other guiding axes Send machine reason the position of and cutting block to Humeca or the guiding axes has dealer for repair been changed Check if there are any burrs on irregularities at the guiding axes or at the cutting block and remove them with sandpaper Remove the block from the guiding axis and rotate the hand Movement of spindle or wheel If rotation is blocked or hand wheel is blocked too heavy apply oil and try again If still problematic contact dealer Measure diameter of blades and Wrong diameter of the check this info with Humeca blades referring to the serial number of the machine Measure thickness of cork holder at the edges and check this info with Humeca Cutting block does not Guiding axis or fit on the guiding axes underside of cutting or it moves too heavy block is damaged Wrong thickness of the cork holder Cork plate too thin cork plate It should not be less than 2 mm 0 08 Take the blades axis out of the Skin is not cut or only machine and look to the cutting partly cut sides of the blades These sides Corcltetoo thin Measure the thickness of the eee should no
15. efect the rear side of the motor noise Air pressure too high fee pressure max 8 bar or psi Remove the cutting block and the motor from the machine and run the blades axis by hand It should freewheel easily If not please contact your supplier for further assistance and trouble shooting Place a cork plate in the machine and cut it Check the depth of the cuttings The depth should be approx 0 5 mm 0 02 If it is far more please contact your supplier for further assistance moistened before use or salt solution before use Take the blades axis out of the machine and look to the cutting sides of the blades These sides should not be shiny If they are replace the blades of replace the blades axis as a whole Blades axis runs too heavy unloaded The drive of the machine is too heavy The blades cut too deep the required work to into the cork plate drive the blades seems to be too high The blades are blunt Movement of cutting The cover of the cutting block under the bridge block was not locked is blocked the block the two screws rise cannot pass under the above the level of the bridge blades axis Take out the cutting block close the cover and lock it Try again using more glue Not enough glue was After spraying the whole applied surface of the graft should have a glossy appearance Graft does not stick to Allow the glue to dry for at least the prefolded gauze Diino imeoiiie oue 6 minutes
16. el without cutting block MEEK cutting machine hand driven cylindrical model without cutting block MEEK cutting machine motor driven without cutting block MEEK cutting machine motor driven gearwheels without cutting block MEEK cutting machine automatic version two axis motor driven MEEK circular ceramic coated blade diameter 38 mm 1 50 MEEK circular ceramic coated blade diameter 39 mm 1 54 MEEK cutting aid 41x41 mm 1 61x1 61 MEEK single cutting block with cork holder MEEK double cutting block with two cork holders MEEK cork holder 3 CP4 MEEK pneumatic foot pedal with connectors and hose 3 KN13 38 MEEK cutting axis with 13 circular blades diameter 38 mm 1 50 3 KN13 39 MEEK cutting axis with 13 circular blades diameter 39 mm 1 54 3 MAC02 MEEK sterilization case 434x254x172 mm 17 1x10 0x6 8 3 MAC03 MEEK sterilization case for cutting axis 180x50x45 mm 7 1x2 0x1 8 3 RM004 MEEK pneumatic block motor with connectors and coupling 3 087 MEEK cylindrical pneumatic motor with connectors and coupling 3 SHD MEEK hand drive set 3 SW01 MEEK serrated wedge cam Disposables 2 3 10 MEEK Micrograft gauze expansion 1 3 with cork plate box 10 pcs 2 4 10 MEEK Micrograft gauze expansion 1 4 with cork plate box 10 pcs 2 6 10 MEEK Micrograft gauze expansion 1 6 with cork plate box 10 pcs 2 9 10 MEEK Micrograft gauze expansion 1 9 with cork plate box 10 pcs 2 3 40 MEEK Micrograft gauze expansion 1 3 wi
17. er 44 Nil Fig 13 Connecting air supply hose to the foot pedal Use small or large diameter clamp and tule Se depending on the diameter of your own tubing Men Small diameter Yo hose clamp Na Small diameter hose tule Quick connector De aad P to foot pedal A diameter hose tule 24 Fig 14 Instruction for fixing the quick connector to the air supply hose 2 Fig 15 Placing the hand drive 1 Fig 16 Placing the hand drive 2 Fig 17 Final position of the in g RRR f aard AEE Fig 19 Holes for applying oil 28 E STATE V150001 Fig 20 and 20A Sterilization case 3 MAC02 Either the yellow cylindrical motor housing or the block shaped motor housing is used This drawing shows both of them 29 oa Fig 21 Prefolded gauze and cork plate Fig 22 Cork plate Fig 23 Cork plate covered with graft Fig 24 Small graft pieces can be used Fig 25 Cutting block with cover open Fig 26 Cutting block with cover closed 30 Fig 27 Always move the cutting block from the side of the hand wheel to the other side never the other way round aw Vaiss Fig 28 The cam is placed on the Fig 29 First lift the cover a little while cutting block to prevent sticking of the pressing the cam down graft to the cover at opening 31 Fig 30 then open the cover Fig 31 The double cutting block Fig 32 The graft is cut into 196 squares Fig
18. harm the instrument The following tables detail the cleaning disinfecting and sterilization process CLEANING Step Description Instruction Accessories Duration Removal of Rinse with Soft brush and tap Until all visible tissue and warm water water pollution is body fluids and use soft removed brush Pre soak Immerse Tap water Minimum 15 optional device into Neutral pH minutes water and disinfectant cleaner liquid cleaner Pre soak Rinse product Tap water Minimum 30 rinse under warm Neutral pH seconds 3 tap water and disinfectant cleaner clean with soft brush Drying Dry with wipe Wipe Until product is and or air Dry air visually dry Automated Place device Washer Minimum total washer and brush in Cleaning solution cycle time 34 washer Washer minutes when neutralizing solution including all steps if applicable below AUTOMATIC WASHER CYCLE Pre wash _ 3minutes OH __ Cleaning Cleaning II or l rewang 1e Rinsel tminute PD Finalrinse tminute 8D Thermal disinfection 25 minutes 110 and drying Pre soak cleaner may be surfactant or protease enzymatic based cleaning solution compatible with aluminium Washer cleaning solution should be a neutral pH or solution compatible with aluminium Neutralizing solution should be appropriate for the utilized cleaning solution based upon the manufacturer s recommendation RECOMMENDED STEAM STERILIZATION PARAM
19. in However you should not to do this when using the MEEK technique because the oil prevents good adhesion of the graft islands to the fabric Use water or buffered salt solution instead so Attention When applying the MEEK technique do not use oil or any other fatty substance when harvesting the graft from the patient 11 3 Preparing the skin before cutting In the MEEK technique the expansion is realized by means of a pre folded gauze fig 21 Each gauze is supplied with a cork plate measuring 42x42 mm 1 65x1 65 fig 22 and packed sterile in a peel pouch Take the cork plate out of the pouch and submerge it into water shortly The cork plate now has to be covered with a piece of split skin graft of the patient with the dermal side facing the cork To this end spread a strip of split skin graft epidermal side down on a smooth surface like a plasticized sterile cloth or the smooth side of a meshgraft carrier Then place the cork plate on the graft and trim the graft to the size of the cork plate The MEEK video clearly shows how this is done in practice If the graft strip was harvested with the Humeca D42 dermatome the width of the strip equals the width of the cork plate which makes it much easier to cover it The cork plate covered with graft is shown in fig 23 Smaller graft remnants can also be used by placing them on the cork plate like a puzzle fig 24 so there is no spillage of graft which is an advantage in c
20. ization Take out the motor Beware that it doesn t fall out of the casing Attention Never sterilize the motor The entire Micrograft cutting machine can be cleaned and steam Sterilized except for the motor Autoclaving occurs at a common temperature of 134 C usually 5 10 minutes or 121 C prolonged exposure time of approx 20 minutes If necessary clean the blades by hand from tissue and body fluids immediately after use To that end loose the two screws 11 fig 1 and lift off the cover 12 of the bridge Take out the blades axis clean it with water and a soft brush and replace it in the machine Attention Never touch the blades with your fingers They are extremely sharp Never touch the blades with some hard object nor place them on a hard surface They ll be damaged Also the inside of the cutting block cover has to be cleaned by hand sometimes Because this surface contacts the skin during cutting on the long term a sticky layer biofilm might be formed If persistent this layer has to be removed mechanically by hand Fig 20and 20A show how the different parts of the MEEK machine can be placed in the MEEK sterilization case 3 MACO2 If you use a different case please leave the blades axis in position on the machine during washing and sterilization as shown in fig 2 in order to prevent damage Alternatively you can put the blades axis separately in the small sterilization case 3 MACO3 fig 21 that Humeca supp
21. least a week for additional grafting Fig 41 shows the result of MEEK grafting on the back of a patient shortly after complete epithelialization 16 11 Trouble shooting roto possmecauso somon Aeae Check all hose connections and 9 repair if leakage occurs Increase air pressure to at least Air pressure too low 4 bar 58 psi Motor does not run Motor runs but blades do not rotate Rotation of blades axis blocked Motor defect Bolts on the blades axis are loose In that case the axis rotates but the blades don t during cutting Coupling on the motor is loose In that case the coupling rotates but the blades axis doesn t Remove the motor from the axis Check whether the blades axis can be run by hand easily rotate the coupling on the axis If not remove the bridge apply oil to the bearings and try again If rotation still blocked contact supplier If rotation only blocked when the bridge is placed contact dealer Take motor out of the machine and connect it to the air supply via the foot pedal Switch on while pressure is at least 4 bar 58 psi If the motor does not run try higher air pressure do not exceed 8 bar or 116 psi If motor still does not work contact dealer Fasten the two bolts on the blades axis first fasten the bolt that is closest to the blades then the other one Take the motor out of the device and connect it to the air supply via the foot pedal Switch on and ch
22. lies for this purpose The cutting block 1 and the serrated wedge 17 are placed next to the machine during Sterilization 3 2 Cleaning and sterilization procedure Parts of Humeca surgical instruments are made out of anodised aluminium This material is corrosion resistant to a large range of chemicals that are in use as cleaning and disinfection agents for surgical instruments However before cleaning and sterilizing the products we ask you to pay attention to the following please consult your Central Sterile Services Department CSSD The instructions for use of the cleaning agent should indicate whether or not the product is suitable for cleaning and disinfecting anodised aluminium Please find out if this is the case and if necessary contact the supplier for this information We recommend using neutral cleaning agents in combination with demineralised water Strong alkaline cleaning agents pH gt 10 cause Clearly visible changes such as marks and colour fading after only a few cleaning cycles The intermediate acidic rinse used in an alkaline cleaning process also may attack the anodised aluminium surface Don t use H20 in the washing process Do not use softened water in the rinsing and disinfection stages After only a few cycles the anodised surface will show clear signs of detoriation After intensive use you will see fading of the coloured parts of the instrument This however is considered as a normal process and it doesn t
23. nsferring the graft to the gauze Put the gauze on a flat surface foil side down Place the cork plate with the autograft downwards on the central pleated area of the gauze as indicated in fig 33 Press firmly and then peel off the cork plate The grafts should now adhere to the gauze fig 34 If the grafts still adhere to the cork plate either the drying time for the glue was not sufficient or some fatty substance paraffin oil was used on the patients skin during harvesting of the graft Note lt is recommended to keep the grafts moistened in case you do not immediately transplant them to the patient If desired you can build up a stock of gauzes before transplantation Cover the gauzes with wet gauzes You can keep them un expanded until transplantation 14 8 Extracting the gauze Hold the gauze at the notched sides and pull LN is completely unfolded in this direction fig 35 the peel pouch this is illustrated by this a Then hold the gauze at the other sides and pull until the gauze is unfolded in that direction too fig 36 On the peel pouch this is illustrated by this pictogram ei Now trim the margins and pull off the aluminium backing you can also fold the margins double down Apply the fabric graft side down to the wound bed and secure it with staples fig 37 Before applying the gauzes to the wound it makes sense to immerse them into sterile water or salt solution This makes the gauzes more tran
24. ork plate 20 lll Service rules CE hallmark responsibilities The Micrograft machine is guaranteed for two years except for the blades This guarantee implies free repair of the machine and accessories when used in a normal way If properly handled replacement of the blades is only necessary after several years They are coated with a ceramic layer and can withstand thousands of cutting procedures Of course blunt blades can be replaced by new ones The management system of Humeca for design production and sales has been certified according to EN ISO 13485 2003 According to the European Medical Device Directory 93 42 EEC the MEEK cutting machine comes under the head of class products The MEEK gauze is a Class sterile product The CE hallmark is indicated on the bridge of the machine and on the package of the prefolded gauzes Do not use other than Humeca blades in the cutting machine Do not use MEEK gauzes and or cork plates in case the package is damaged The manufacturer considers being only responsible for the safety and performance of the MEEK cutting machine if it is used in the way as described in this manual For replacements only original spare parts must be used Replacements have to be carried out by the manufacturer or by one of his authorized local dealers 21 IV Ordering When ordering please refer to the following article numbers Equipment 3 HD BLO MEEK cutting machine hand driven block mod
25. sparent better visibility and it also flattens the fabric removes the pleats Place the gauzes with grafts adjacent to each other on the wound fig 38 If desired gauzes can be cut to graft smaller areas fig 39 Apply non adherent Vaseline gauzes to cover the grafts if desired use antibacterial cream or solution and wrap with bandages Keep undisturbed for the first two days then refresh daily Alternatively the grafts can be covered with a dressing that slowly releases an antimicrobial agent like ionic silver In that case daily refreshment of the dressings is not required 9 Removing the fabric from the wound Six days post grafting the grafts have grown sufficiently into the wound bed to allow removal of the fabric fig 40 Staples are removed and the fabric is gently peeled off drawing below leaving the graft islands in situ on the wound bed Sometimes antibacterial cream is put on the fabric on day 5 to facilitate removal on day 6 not like this but like this 15 10 Local therapy We like to point out that the following is only a suggestion off course you can follow your own experiences and attune them to the MEEK method In fact there is not much difference between local therapy after MEEK grafting and mesh grafting The main difference is the presence of a fabric immediately after grafting in case of MEEK For a good graft take it is essential that the wound bed is kept moist after transplantation Mostly
26. t be shiny If they are replace the blades of replace the blades axis as a whole not rotate to that matter changed guiding axes Screws of the bridge Fasten the two screws of the era aa ened bridge and check whether or not properly the bridge is positioned correctly Skin sticks to the cover A biofilm was formed of the cutting block at the underside of the Clean the underside of the when it is opened grating of the cover or it cover thoroughly preferably even after proper use might be polluted by with some abrasive liquid of the cam and other substances like cleaner moistening the cover MEEK adhesive Problem Possible cause The graft was too thick Reduce the thickness of the it not only consists of an graft taken from the patient by epidermal and a dermal modifying the adjustment of the layer but also alayer of dermatome If the graft was fatty tissue was taken already taken off scrub or cut Fat is very slippy and it the fatty tissue layer from the Skin moves on the causes the graft to move graft and repeat the MEEK cork plate during during cutting technique cutting The cover of the cutting Check whether the cover is block was not properly locked properly Also check the coced springs in the locks If a spring broke replace it The cutting block Mica Put the block on the machine at moved under the bridge in the wrong direction the side of the hand wheel Motor makes too much present or d
27. th cork plate box 40 pcs 2 4 40 MEEK Micrograft gauze expansion 1 4 with cork plate box 40 pcs 2 6 40 MEEK Micrograft gauze expansion 1 6 with cork plate box 40 pcs 2 9 40 MEEK Micrograft gauze expansion 1 9 with cork plate box 40 pcs 2 9190 MEEK adhesive bottle 200 ml 6 8 fl oz 2 JG598 STERILIT oil for surgical instruments bottle 50 ml 1 7 fl oz 22 V Supplier In case of any problem or inquiry please contact your local dealer or Humeca BV P O Box 40175 Het Bijvank 251 a 7504 RD Enschede 7544 DB Enschede The Netherlands The Netherlands Phone 31 53 4762619 Fax 31 53 4771905 E mail info humeca com Web www humeca com Humeca is an EN ISO 13485 2003 certified company NOTE Video movies about the MEEK procedure and handling of the equipment are available from the Humeca website www humeca com section MEEK Micrograft submenu videos MEEK Micrografting Pictures cylindrical motor and hand drive 23 15 F Jen PE sat Fig 24 Fig 1 MEEK cutting machine main parts 10 Y NaN cod Cai x 2 Blades axis with the bearings in their seats and the coupling to the left side Fig 4 Placing motor in casing w Fig 6 Placing motor on the machine a Fig 9 Motor in position on the machine Fig 10 The foot pedal Fig 11 Connecting the hose to the motor Fig 12 Hose correctly connected er a hb tt ett
28. the MEEK gauzes are first covered with a non adherent gauze with antibacterial cream Then a layer of gauzes sometimes soaked in an antibacterial solution like for instance 1 betadine in aquadest is applied Immerse gauzes into the antibacterial solution of choice squeeze them by hand and place them on the wound Finally wrap bandages around the affected area For the first 2 days the wound is kept undisturbed to avoid movement of the graft islands After that period dressings are refreshed daily Alternatively the grafts can be covered with some wound dressing that slowly releases an antibacterial agent like silver ions In that case daily refreshing of the dressings is not required When the Micrograft gauzes are not removed after six days epithelialization continues normally under the gauzes So if desired removal can be delayed to a later stage Sometimes after removal of the MEEK gauzes allografts meshed 1 1 5 are put on top of the islands so called sandwich grafting This is only useful in case of a clean wound and only after primary excision Allografts are especially useful when a large expansion ratio like 1 9 is applied When the expansion ratio is 1 6 or less allografts are not needed Sometimes the MEEK technique is repeated on small parts of the wound particular to supply new granulation tissue with graft islands If too much graft was taken from the patient the surplus can be stored in a refrigerator for at
29. the skin before cutting 4 Placing the cork with the graft into the cutting block 5 Cutting 5a The first cutting 5b The second cutting 6 Applying adhesive to the autograft 7 Transferring the graft to the gauze 8 Extending the gauze 9 Removing the fabric from the wound 10 Local therapy 11 Trouble shooting lll Service IV Ordering V Supplier Pictures SECTION II TECHNICAL DATA NODAR A SECTION INSTRUCTIONS FOR USE AND INSTALLATION l Mounting and dismounting the machine See fig 1 and 2 The machine consists of a cutting block 1 a frame 2 and a pneumatic motor in a cylindrical casing 3 or a hand drive Rotation of a hand wheel 4 causes the cutting block 1 to move under a bridge 12 where 13 circular blades cut through the skin Attention Never sterilize the motor 1 Assembly of the machine Check whether the blades axis 10 is in its right position as shown in fig 2 the bearings should be in their seats and the coupling 15 should point to the left side when facing the hand wheel side of the machine Place the bridge 12 fig 1 on the frame and fasten the bolts 11 by hand 1a Placing the pneumatic motor The procedure to be followed for placement of the motor on the machine is illustrated in fig 3 9 Because the motor is not sterilized it is encapsulated in a sterile cylindrical casing fig 3 A circulating nurse places the unsterile motor 22 into the sterile casing 3 that is held in position by
30. uration should be followed explicitly In case cleaning and disinfecting products of Diversey are used a suitable procedure is also presented in a joint publication of Humeca and Diversey It is available on request You can also download it from www humeca com In cases of doubt please contact Humeca or your local distributor before using the instrument 10 ll The Micrograft procedure 1 Determining the expansion factor Before harvesting the autograft from the patient the expansion factor is determined In low and medium sized burns there is no lack of donor sites and thus no large expansion is required In these cases an expansion factor of 1 3 or 1 4 is enough for quick epithelialisation In extensive burns however the 1 6 expansion is recommended and only in extreme cases of very high TBSA burns a 1 9 expansion is required Compared to meshgrafts the quantity of graft required in the MEEK technique is about half as much Once the expansion factor is determined the total donor site area can be roughly calculated and the graft is taken from the patient The expansion factor is clearly printed on the peel pouch of each gauze and it is also indicated on the gauze itself in one of the corners the expansion 3 4 6 or 9 is relief printed in the aluminium foil 2 Harvesting the graft Before harvesting the graft the skin of the patient is often greased with some oil to enable a smooth run of the dermatome over the sk
31. utting block and keep them at a precise distance in order to allow total cutting of the skin and only partial cutting of the cork plate Furthermore the main frame allows horizontal movement of the cutting block over the guiding axis by turning the spindle by means of the hand wheel Total weight of the main frame is 4 1 kg 9 1 Ib 4 Blades axis The blades axis 3 KN13 38 is shown in fig 3 below gt MU j 9 O Z Of i GD rd Fig 3 The blades axis 41 The blades axis consists of No in Ordering fig 3 no Description Material axis st steel bearing bronze round nut st steel coupling hub chemically nickel plated steel blade 38mm 1 5 st steel ceramic coating locking ring DIN 471 6x0 7 st steel cotter DIN 6885 st steel The function of the blades axis is to align the blades in exact position and to cut the skin by rotation of the axis Total weight of the blades axis is 0 454 kg 1 0 Ib 5 Cutting blocks There are two different types of the cutting block single and double They are shown in fig 4 and 5 respectively 5a Single cutting block Fig 4 Single cutting block assembled and in exploded view 42 The single cutting block fig 4 consists of Ordering no Description Material base block anodised aluminium half nut brass single base plate K anodised aluminium central cam st steel countersunk screw DIN7991 M3x8 A2 st steel hinge axis st steel
Download Pdf Manuals
Related Search