E80404 C Nurse Quickguide GB - Single
Contents
1. by Entific Medical Systems for a better life Products in this manual are protected by the following patents US 5 735 790 US 5 935 170 EP 0715839 EP 0715838 and corresponding patents in other countries and pending patent applications All products can be subject to change without notice No part of this publication may be replaced stored in a retrieval system or transmitted in any form by means electronic mechanical photocopying recording or otherwise without the prior written permission of the publisher Caution Federal law USA restricts this device to sale by or on the order of a medical practitioner Entific Medical Systems AB 2005 All rights reserved Contents Contents e Instruments for Set up ccaspodddddsdoo 4 Procedure step by Step c 6 e Preparation for surgery c 8 e Sterilization guidelines cccaasaa 9 e Implantmed sterilization guidelines ccc 11 e Check LSC occ 13 Nurse Surgical Assistant Quickguide 3 Instruments for set up Instruments for set up Surgical instruments Pick n Place instrument set for Baha The instrument set for Baha includes instruments for fixture abutment connection A complete list of the instruments included is described in detail below 1 1 Surgical organizer titanium 2 Dissector 7 3 Forceps titanium 4 Cylinder wrench d 5 Screwdriver Unigrip 95 mm 6 Counter torque wrench 7 7 Drill ind2. commonly used disinfectants for surgical instrument or alcohol ethanol 70 v v or isopropanol 45 v v with additive of surfactants Let the instruments soak in the disinfectant solution for at least 10 minutes Nurse Surgical Assistant Quickguide Sterilization guidelines 10 Drying Maintenance inspection and testing Packaging Sterilization Storage Manufacturer contact Nurse Surgical Assistant Quickguide Automatic Let the instruments dry in the washer disinfector if drying is included as a part of the washer disinfector cycle Do no exceed 137 C 278 6 F Manual Dry each item with a clean lint free towel or let it air dry under controlled conditions Place the instruments into the appropriate instrument organizer or the instrument cassette before sterilization All instruments Visually inspect for damage and wear Cutting edges should be free of nicks and present a continuous edge Where instruments form part of a larger assembly check assembly with mating components Packaging materials which are according to EN 868 should be used Singly Individual items can be packaged in heat sealable pouches The choice of sterilization temperature should follow the packaging material manufacturers recommendation Ensure that the pack is large enough to contain the instruments without stressing the seals In sets The instrument cassette loaded with the instruments should be packaged in a doub
3. ace over abutment directly on to the wound Apply at least two layers of gauze to exert pressure to graft Healing cap Cover with gauze and mastoid bandage One day post op Remove outer bandage Leave the dressing gauze dressing and healing cap in place Keep dry 5 6 days post op Remove healing cap Carefully remove dressing and gauze dressing Gently clean wound with normal saline gauze or tips Remove any dried blood Re apply dressing and gauze dressing and healing cap Patient can wash hair if dressing is protected 10 14 days post op Remove the dressing Remove sutures Gently clean any dried blood or scabs Patient can wash hair If healed no further dressing required Once area is healed the patient needs to be instructed on long term cleaning of the area with a soft brush or non alcohol baby wipes Nurse Surgical Assistant Quickguide Preparation for surgery Dressings It is vital that the skin is prepared properly to avoid tissue and hair re growth that may cause irritation or wound healing problems around the abutment The patient may then be unable to wear their sound processor or prosthesis Care is taken in the choice of dressing and aftercare of the wound New wound care techniques can reduce complications increase comfort for the patient and decrease the time required by the clinician There are now many dressings availab
4. be used in conjunction with gauze as it does not have any absorption properties Can be cut to shape and left in place for 5 7 days or until colour is lost Avoid iodine sensitive patients Allevyn is a trademark of Smith amp Nephew Mepitel is a registered trademark of M lnlycke Inadine is a registered trademark of Johnson amp Johnson Sterilization guidelines Sterilization guidelines The devices shall be reprocessed in accordance with established local routines for surgical instruments at the hospital clinic Entific Medical Systems gives the following recommendations WARNINGS Do no exceed 137 C 278 6 F Limitations on Repeated processing has minimal effect on these instruments End of life is normally reprocessing determined by wear or damage Containment and It is recommended that the instruments are reprocessed as soon as is reasonably transportation practical following use If the reprocessing is delayed the instruments should be submerged into disinfectant solution to prevent drying Preparations Before cleaning the following instruments should be disassembled Small parts screws for cleaning can remain in the small box in the cassette during washing and be assembled afterwards e Fixture mount standard Unigrip e Fixture mount short Unigrip e Dermatome e Cylinder wrench Cleaning Automated All reusable surgical instruments including instruments with plastic parts can be automatically cl
5. ction is recommended Use certified disinfectants e g DGHM tested e Note the action times of the disinfectants used Manual cleaning e Rinse with cold water with the aid of a brush not applicable for U K or wipe clean using an alcohol solution e Then remove any liquid residues absorbent cloth blow dry with compressed air Sterilization and storage W amp H recommends sterilization according to prEN 13060 class B e Note the instructions of the unit manufacturer e Only sterilize clean motors and accessories e Wrap motors and accessories in sterile goods packing REF 02802400 from the pack supplied e Make sure that you only remove dry motors and accessories from the sterilizer e Store sterile goods dust free and dry Implantmed sterilization guidelines Nurse Surgical Assistant Quickguide 11 Implantmed sterilization guidelines 12 Nurse Surgical Assistant Quickguide Permitted sterilization methods Vacuum sterilization remove the sterilization cap e Steam sterilization according to prEN 13060 using a sterilization holding time of a minimum of four minutes at 134 3 C 273 2 5 4 F Or Gravity sterilization push the sterilization protection cap onto the motor attach ment e Steam gravity sterilization by a sterilization holding time of a minimum of five minutes at 134 3 C 273 2 5 4 F Sterility of irrigation tubing Sterile irrigation tubing is included with the e
6. eaned combined with thermal disinfection Equipment Automatic standard approved washer disinfector Detergent Low alkaline detergent recommended from the manufacturer of the washer disinfector Final rinsing phase disinfection stage 85 93 C 185 199 4 F for 1 3 minutes Water quality Processed water or according to the hospitals procedure When unloading the washer disinfector check the narrow parts on the instruments for complete removal of visible soil If necessary repeat cycle or use manual cleaning Cleaning Manual All other surgical instruments including instruments with plastic parts can be manually cleaned Equipment Interdental brush soaked with detergent solution Items that can be submersed under water should be cleaned and brushed under water in order to avoid aerolisation spray If additional cleaning is necessary put the instrument in a manual ultrasonic bath Detergent All commonly used low alkaline detergents for surgical instruments Initial pre rinsing phase Rinse in cold water The temperature should not exceed 35 C 95 F in order to prevent the blood to coagulate Final rinsing phase Rinse carefully in hot water until the instruments are free from all detergent solution Water quality Processed water or according to the hospitals procedure Chemical disinfection Before the manual cleaning if risk for infection otherwise after the manual cleaning Disinfectants All
7. fixture ST 4 mm w Baha abutment 90434 Most commonly used Cover screw Unigrip 90360 Only used for two stage procedures Cover screw space w internal hexagon 90620 For use with two stage procedures For use with sleeping fixtures Healing cap HCB 673 0 Should be sterilized before use steam 137 C 278 6 F Baha blade 90329 For the Dermatome Sterile packed Biopsy punch 04 mm 90055 In surgery 4 mm components are the most commonly used but a selection of both should be available Nurse Surgical Assistant Quickguide Procedure step by step Nurse Surgical Assistant Quickguide Figure Procedure step by step see Fig see Fig see Fig see Fig see Fig see Fig see Fig see Fig see Fig 1 wN 4 6 7 8 9 see Fig 10 see Fig 11 see Fig 12 Shave the hair where the Baha device is to be placed Create a sterile field around the Baha site Position of the implant is decided using the indicator for Baha ruler and pen The area is infiltrated with local anaesthesia The periosteum is marked for implant placement using dye and a needle The flap is raised using the Dermatome silvers knife or blade The subcutaneous tissue is removed A scalpel is used to make a cruciate incision in the periosteum The raspatorium is used to raise the corners of the periosteum The guide drill should initially be used with the spacer in place allowing drilling to an
8. icator 8 Connection to handpiece 9 Fixture mount Unigrip should be placed into titanium organizer 10 Indicator for Baha 11 Machine screwdriver Unigrip 25 mm 12 Hexagon screwdriver 20 mm 2 13 Raspatorium 14 Abutment inserter 8 15 Instrument cassette 9 Note The words fixture and implant are interchangeable and are used through out this Quickguide 10 11 12 13 14 15 Nurse Surgical Assistant Quickguide Instruments for set up Implantmed a Unit power lead Irrigation stand Foot pedal Motor handpiece Disposable irrigation Motor support Baha Dermatome Dermatome Disposable blade Vaseline liquid paraffin or mineral oil Instrument mounting of Baha Dermatome 1 Mount the driver pin into the handpiece 2 Insert the blade into the Dermatome with the single groove facing upwards 3 Keep the blade centred when inserting the handpiece into the Dermatome Make sure the driver pin mates the groove in the blade 4 Lift the securing screw over the handpiece and tighten firmly 5 Check the function by running it with the high speed motor 2 000 3 000 rpm Caution Do not turn Dermatome handpiece until screw is tightened Blade may fall out 4 Disposables Denomination f 1 comments O Guide drill 3 4 mm 90415 With spacer Drill countersink 3 mm 90416 If 3 mm drill is used Drill countersink 4 mm 90417 If 4 mm drill is used Flange fixture ST 3 mm w Baha abutment 90480 Flange
9. initial depth of 3 mm surgeon should use irrigation throughout drilling The drills have a latch grip connection for the handpiece 20 1 and are used on high speed 2 000 rpm with irrigation there is enough bone depth to continue to 4 mm The drill indicator should be clipped on and used throughout to help with the correct angle Once a depth of 3 mm has been reached the surgeon should check with the dissector if If so the spacer is removed from the guide drill to allow drilling to a depth of 4 mm The relevant drill countersink 3 or 4 mm is then opened and attached in the same way Continue with the same size throughout All drills are single use and disposable The undermining around the site is carried out with a scalpel this can be done prior to drilling if preferred The flap is laid back and stretched out with skin hooks A hole is punched over the implant site with the biopsy punch speed and check on drill the ampoule holder in the tray marked implant Connect the abutment inserter to the handpiece Press the button marked with an implant on the Implantmed in order to change to slow Hold the implant ampoule upright unscrew the cap and stand the ampoule directly into Pick up the self tapping fixture with pre mounted abutment using the abutment inserter connected to the handpiece Surgeon should use irrigation once implant is initially inserted The implant must not touch anything at all drapes glo
10. le but for a graft site it is generally accepted that a non or low adherent wound contact layer and light pressure dressing will be adequate You can use many types of dressings but a few suggestions follow Foam dressing A foam such as Allevyn Hydrocellular Smith amp Nephew which is a hydrophyl lic polyurethane dressing with a trilaminate structure It has three dimensional polyurethane net which is low adherent to the wound interface It is made of hydrophilic foam which absorbs and retains fluid and has an outside layer of oppo site film It can be used for low to medium exuding wounds and can be cut to shape to fit around the abutment and under the healing cap The dressing can be left in place for up to seven days Soft silicone wound contact layer A soft silicone mesh such as Mepitel M lnlycke which is a non adherent dressing made of a medical grade silicone gel bound to a soft and pliable polymide netting that allows the passage of exudate This is an ideal wound contact layer as it does not adhere to the wound at all can be left in place for seven days and cut to size Antiseptic dressing An antiseptic such as Inadine Johnson amp Johnson is a low adherent knitted viscose dressing impregnated with 10 povidone iodine in a water soluble poly ethylene glycol base It is generally used for the prophylaxis and treatment of a wide range of bacterial protozoal and fungal organisms Inadine needs to
11. le layer of a sterilization wrap using the appropriate method Steam sterilization with saturated steam under pressure is recommended for all surgical instruments the surgical organizer and the instrument cassette The sterilization parameters should be according to EN 554 as below or could be set by a validation study Equipment Validated autoclave process Sterilant Saturated steam It is very important that the sterilization chamber is completely filled with saturated steam during the holding time Do not exceed 137 C 278 6 F with restriction to the product materials Drying According to the performance of the autoclave carefully check that the instruments are dry before storing Temperature 134 C 273 2 F 121 C 249 8 F Holding time minimum 15 minutes Sterilized and packed articles should be stored in a controlled area where they are protected from dust moisture and large temperature changes See end of this brochure for telephone number and address of local representative or telephone 46 317333700 The instructions provided above have been validated by the medical device manu facturer as being capable of preparing a medical device for re use It remains the responsibility of the processor to ensure that the processing as actually performed using equipment materials and personnel in the processing facility achieves the desired result This requires validation and routine monitoring of the p
12. quipment supplied This irrigation tubing is disposable and must be thrown away after each use Please note the expiry date and the relevant regulations for the disposal of irrigation tubing Servicing The motor bearings are lubricated for life no oil or other maintenance is necessary Technical safety checks should be carried out according to national regulations or at least once every third year or every 500 sterilization cycles W amp H recommends the use of their lubrication Service Oil MD 400 which can be purchased from W amp H This should be used for the contra angle handpiece Note Please refer to the W amp H User s Manual that is supplied with the Implant med for further information Check list Implantmed Unit Power lead Irrigation stand Foot pedal Motor Handpiece OoOOddd Pick n Place instrument set Sterilization cassette Surgical organiser Dissector Forceps titanium Cylinder wrench Screwdriver Unigrip Counter torque wrench Drill indicator Connection to handpiece Fixture mount Unigrip Indicator for Baha Machine screwdriver Unigrip Hexagon screwdriver Raspatorium OOOOOOOOAOAOADOOD Abutment inserter Baha Dermatome Dermatome O Vaseline or liquid paraffin Entific components O OoOdddO OoOdOddO Dermatome blade Guide drill 3 4 mm Drill countersink 3 mm Drill countersink 4 mm Flange fixture ST 3 mm w Baha abutment Flange fixture ST 4 mm w Baha abutment Cover sc
13. rew Unigrip Cover screw int hex Biopsy punch Healing cap Disposable irrigation Theatre extras non Entific IUOUUOUUUUUU u Oo h Razor for shaving the hair Ruler and pen Dye and needle Local anaesthetic amp syringe Antiseptic betadine solution Basic ear drape set Basic ear instrument set Suction tubing and tip Sterile saline bag Gauze swabs Sutures Dressing and bandage Nurse Surgical Assistant Quickguide 13 Entific Medical Systems P O Box 16024 SE 412 21 G teborg Sweden Phone 46 317333700 Fax 46 313358860 E Mail info entific com Visit www entific com J entific Medical Systems 17213 Geson SkandiaTryckeriet Printed in Sweden E80404 C 05 04
14. rocess Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences Implantmed sterilization guidelines Preparations before cleaning The handpiece must be removed from the motor and it is recommended that it is disassembled cleaned and thereafter assembled and lubricated according to the W amp H Handpiece Manual Disinfection cleaning and sterilization e Wear protective gloves e Disinfect and clean the motor immediately after every surgical treatment e Sterilize the motor following manual disinfection and cleaning e Motor with cable pump tubing must be sterilized prior to every use e Do not twist or kink the motor cable Do not coil it too tightly This instruction is not necessary when a sterilization cassette is utilized optional accessory Control unit and foot control Manual disinfection and cleaning The front panel of the control unit is sealed and may be wiped clean If heavily soiled clean first with disinfection cloths e Disinfect using surface disinfectants spray disinfection is recommended e Use certified disinfectants e g DGHM tested e Note the action times of the disinfectants used Motor Push the sterilization protection cap 04032600 onto the motor attachment Manual disinfection If heavily soiled clean first with disinfection cloths e Disinfect using surface disinfectants spray disinfe
15. ves or instruments as this could negatively affect osseointegration This is vital to the success of the procedure Once the self tapping fixture with pre mounted abutment is in place the handpiece with inserter is removed and passed back The skin flap is now positioned over the site and the hole is pulled over the abutment The flap is then sutured in position The healing cap and a dressing are then put in place Nurse Surgical Assistant Quickguide 7 Preparation for surgery Dressing protocol using foam Operating theatre dressing Cut or biopsy punch a 94 mm hole in foam dressing Apply over abutment directly on to the wound Healing cap to hold in place Cover with gauze and mastoid pressure bandage One day post op Remove outer bandage Leave foam dressing and healing cap in place Keep dry 5 6 days post op Remove healing cap Carefully remove foam dressing Gently clean wound with normal saline and gauze Remove any dried blood Re apply foam dressing and healing cap Patient can wash hair if dressing is protected 10 14 days post op Remove foam dressing Remove sutures Gently clean any dried blood or scabs Patient can wash hair If healed no further dressing required Dressing protocol using silicone or antiseptic wound contact layer Operating theatre dressing Cut or biopsy punch a 4 mm hole in the dressing Pl
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