Operating Instructions
Contents
1. Warning Always fit a wire pin guard when driving or removing wires pins Fitting the Wire Pin Guard e Grip the wire pin guard and gently push it into the rear of the handpiece e The wire pin guard will snap into place Wire Pin Insertion e Set the trigger mode selector to safety off e Insert the wire pin into the front of the wire pin driver to the required position Do not grip the actuating lever whilst inserting the wire pin e Test that the driver is gripping the wire pin correctly 19 Wire Pin Driving Insertion Set the Trigger Mode Selector to the required mode Pull back the lever to grip the wire pin Depress the trigger s to rotate the wire pin Expose more wire pin after penetration by releasing the top trigger and the actuating lever and sliding the instrument up the wire pin Repeat the driving process e If the wire pin is to be removed do not trim the wire pin less than 20mm 3 2 20mm must be protruding from the surgical site for the instrument to be able to grip the wire pin Wire Pin Driving Removal e Set the Trigger Mode Selector to the required mode e Slide the instrument over the exposed wire pin e Pull back on the actuating lever to grip the wire pin e Depress the trigger s to rotate the wire pin in the required direction Pull the instrument away from the fixated site to remove the wire pin e Take care not to bend the wire pin during removal Immediately after use clean th2. The placement of items in automatic washer disinfector baskets can be a critical factor in achieving effective cleaning Selection of the basket type and position of the items to be cleaned should be done by suitably trained personnel in accordance with the manufacturer s instructions for the washer disinfector 3 Follow manufacturers loading instructions and select the appropriate cycle recommended The cycle should include Pressurized cold water rinse maximum 35 C Hot water wash minimum 55 C See note regarding detergents Warm water rinse Disinfection rinse minimum 80 C for 1 minutes Drying cycle 4 Remove disinfected instruments from the washer disinfector to a clean area Remove the washing caps and the sagittal saw blade clamp washing spacer if fitted 5 Visually inspect each item and verify the cleaning process is complete and all contaminants have been removed in accordance with local reprocessing guidelines Disinfection Thermal disinfection is recommended and included in the automatic washer disinfection cycle See above Maintenance Lubrication of the pneumatic Handpiece motor is not essential but will enhance the life and performance of the instrument 1 Apply 3 drops of surgical instrument oil part no 30982 Non sterile into the instrument air inlet after cleaning 2 Connect the instrument to an air supply and run for at least 20 seconds to ensure adequate dispersal
3. amp Liability De Soutter Medical guarantees all instruments attachments and accessories to be free from defects in material and workmanship for one year from the date of purchase De Soutter Medical is not liable by warranty or otherwise in the case of any of the following e Abuse misuse or use in other than a surgical environment e Disassembly alteration or unauthorized repair e f the product has not been used in a reasonable manner and in full compliance with the written instructions This guarantee does not affect your Statutory Rights in accordance with 1999 44 EEC 23 United Kingdom De Soutter Medical Limited Halton Brook Business Park Weston Road Aston Clinton Bucks HP22 5WF United Kingdom Tel 44 0 1296 634 000 Fax 44 0 1296 634 033 Email info de soutter com Internet http www de soutter com Australia De Soutter Medical Australia Pty Ltd 2 12 14 Apollo Drive Osterreich De Soutter Medical Austria Niederlassung Osterreich Hallam Hofkirchnergasse 3 1 30 Victoria 3803 A 3400 Klosterneuburg Australia Osterreich Tel 61 0 3 9702 4441 Tel 43 0 676 96 71 770 Fax 61 0 3 9702 4484 Fax 43 0 2243 21 656 Email australia de soutter com Email austria de soutter com Belgium France De Soutter Medical Belgium De Soutter Medical France In De Bruel 30 949 Avenue Park des Expositions 3620 Lanaken 33260 La Teste de Buch Belgium France Tel 32
4. clockwise with the tool provided to tighten the blade clamp mechanism Check that the blade is correctly located whilst tightening clamp screw e Check that the blade is secure Removal e Rotate clamp screw anti clockwise to release blade e Gently pull blade from attachment Technical Description and Part Number Details SI O Part No Speed Blade Hub Type Blade Wrench Supplied For full details of suitable saw blades refer to Stericut data sheets NZ 450 Quick Release Sagittal Saw Attachment Blade Clamp Operation Insertion e Fit the Sagittal Saw attachment to the handpiece With the blade clamp in the open position insert the blade Push the blade clamp down Tighten the blade clamp using the clamp nut Check that the blade is secure in the blade clamp Refer to diagram below Removal e Grip the instrument and pull the clamp nut and turn anticlockwise to unscrew the blade clamp e Lift the blade slightly and remove it from the clamp Refer to the diagram below T Part No Speed Blade Hub Type De Soutter Medical S88 CZ 450 Reciprocating Saw Blade Clamp Operation Insertion e Rotate the blade clamp anti clockwise with the tool provided e Insert blade into the blade holder e Rotate the blade clamp clockwise with the tool provided to tighten blade clamp mechanism Check that the blade is correctly located whilst tightening clamp screw e Check that the blade is
5. 0 89 47 15 37 Tel 33 0 5 56 54 89 36 Fax 32 0 89 70 12 19 Fax 33 0 9 70 61 37 60 Email belgium de soutter com Email france de soutter com Deutschland ltalia De Soutter Medical Germany Niederlassung Deutschland Kladenfloss D 66625 Nohfelden Germany Tel 49 0 68 52 99 12 46 Fax 49 0 68 52 99 12 47 Email de soutter t online de De Soutter Medical Italia Palazzo Marco Polo Il Girasole 20084 Lacchiarella Milano Italia Tel 39 0 2 9009 4098 Fax 39 0 2 9009 2673 Email info de souttermedical it Ref 1957en 1 6
6. Surgical Instrument Oil 25ml bottle Part No 30982 SECTION 4 MPZ SYSTEM ATTACHMENTS DZ 450 Drill amp QZ 450 Burr Attachments Chuck Operation Universal Jacobs Insert the drill bit into the chuck and tighten with the chuck key Keyless Insert the drill bit into the chuck grip the smaller chuck ring and rotate the chuck body to tighten Note Do not operate in reverse as this will un tighten the chuck Quick Release Pull the chuck sleeve back and insert the drill bit Rotate the drill bit until it enters the chuck fully Release the chuck sleeve Check that the drill bit is locked in the chuck by pulling the drill bit away from the attachment Refer to the diagram below a up ni n a zu S cm Supplied Accessories DZ 450 Universal Chuck Key for 0 6 35mm Chuck Part No 30062 Chuck Key for 0 4mm Chuck Part No 8780 Technical Description amp Part Number Details Part 1 DZ 450 DZ 450 DZ 450 DZ 450 Universal Universal Quick Release Keyless 0 6 35mm 0 4mm AO 0 3 2 Jacobs Jacobs Part No 14240 Speed 0 1000 rpm Chuck Capacity 0 6 35mm 0 4mm Quick 0 3 2mm Release Cannulation 4 1mm 3 1mm 1 9mm 2 4mm Diameter Part 2 DZ 450 DZ 450 Dz 450 QZ 450 Keyless Quick Q Release Q Release 0 8 6 4 Release Hudson Burr Trinkle Zimmer ISO 6360 Part No 14120 Speed 0 1000 rpm 0 1000 0 1000 0 1600 Chuck Capacity 0 8 6 4mm Quick Quick Quick Relea
7. e 1 Plus Vaious Air Supply Hose 1 Various MPZ System Handpiece Attachments 8 Various EPV System Handpiece Attachments 5 Other Optional Accessories Air Supply Hoses A wide selection of De Soutter Medical standard and Wash Assist air hoses are available to suit different connection systems refer to the accessories brochure for further information Foot Pedal Control MPZ 451 only Model Inlet Connection Type Part No FV 220 MA7 14900 FV 221 Any De Soutter Medical Wash Assist Hose MPZ 14910 EPV HST amp DPZ With Suitable Hose Probe Fitting FV 222 MA7 15000 SECTION 2 MPZ SYSTEM ASSEMBLY Air Supply Hose The air supply hose is self sealing when disconnected from the handpiece The hose connects to the handpiece with a quick release bayonet connection To attach the hose Grip the hose connector and engage the pins into the bayonet slots Push the connector towards the handpiece Twist the connector clockwise The connector will come to a stop the hose is now connected Pull gently on the hose to check that the hose is securely connected to the handpiece To remove the hose Hold the handpiece and grip the hose connector Twist the hose connector anti clockwise pushing the hose connector towards the handpiece Refer to the diagram Attachments All the attachments for the MPZ system connect to the handpiece in the same way Attachment Connection Ensure that the m
8. e attachment to remove debris Technical Description amp Part Number Details o Wo PAGO Part No Speed Cannulation Diameter Acceptable wire diameters Supplied Accessories Cleaning Brush Part No 8120 Wire Pin Guard Part No 9570 Optional Accessories Diameter 150mm long Sterile 0 7mm K92 071 0 9mm K92 091 1 4mm K92 111 1 6mm K92 161 All K wires feature trocar points at both ends Sterile packed K wires are supplied in boxes of 5 20 SECTION 5 EXPLANATION OF SYMBOLS Explanation of Symbols Refer to the Operating gt X Vacuum Steam Sterilize Instruction Manual Rotate to Lock Blade u ri Rotate to release Attachment Speed Control f Reverse rotation Forward rotation Do Not Immerse Safety Off Single Use Only W I Refer to the Operating Instruction Manual o SID 21 SECTION 6 SYSTEM FAULT FINDING Fault Finding Fault Instrument does not run Instrument runs slowly or seems to lack power Attachment will not fit into handpiece Accessory will not fit into attachment Instrument seems to cut slowly Possible Cause Air supply faulty Trigger Mode Selector set to Safety Insufficient lubrication Insufficient air supply pressure and or flow rate Regulator malfunctioning Drive spindle misaligned Debris inside chuck collet blade clamp Accessory is damaged Worn accessory Remedy Check air supply Check hose connectio
9. er maximum 35 C avoiding fluid ingress via the air hose inlet Scrub the components thoroughly using a suitable detergent and nylon brushes to remove all visible traces of contaminant Pay attention to recesses blind holes and cannulations Note Manually open and close chucks and blade clamps Use suitable nylon brushes to reach difficult surfaces and inside cannulations Flush through these areas to ensure any trapped contaminants are removed 2 Rinse off all traces of the detergent with de ionized or distilled running water 45 65 C 3 Shake off excess water and dry surfaces with a lint free cloth Visually inspect each item to verify that all contaminants are removed in accordance with local reprocessing guidelines Automatic Equipment Cleaning Automatic Washer Disinfector capable of meeting relevant national and international cleaning and disinfection standards i e IS015883 OR HTM2030 Method 1 Large contaminant deposits should be removed manually using the method described in Manual Cleaning item 1 Pay particular attention to recesses blind holes chucks clamps and cannulations Note It is recommended that chucks be set to a middle position following the above pre wash This facilitates the automatic washer disinfection process 2 Place the equipment onto the wire basket Ensure all items are separated Ensure washing caps are securely fitted to the handpiece and air supply hose if specified Note
10. i Operating Instructions English MultiDrive MPZ 450 MPZ 451 Pneumatic Modular Small de Soutiter Bone Instrument System MEDICAL DE SOUTTER MEDICAL MPZ INSTRUMENT SYSTEM Index IS ee bad Page Section 1 General InStrueti nsau nne ae Eed 2 Warnings and Safety Rules oooccocooninococcccccncccanancccccnnccnnnnnnoncn canon cana nnnncnnnos 2 Product BE le e EE 2 Air SUPPIY re ee een nenn 2 Reprocessing InstruciONS ici 4 Sterilization Accessory Part Number Details eneee seeenne 7 System Optional Acces sones a 7 Section 2 MPZ System Assembly ooococccconococccoccccccccnnanconcnnoncnnancnncncnccnnnns 8 Air Supply HOSE nee ee a ee eran ane bee 8 AtachmeniS s miese 9 section 3 MPZ Handpiece vns ii ees 11 MPZ 490 45 Rente 11 SUPDIIERACCESSONES es ern 11 Section 4 MPZ System Attachments nnnnnnnnnennneennensneenseesseenseeeeeenee 12 DZ 450 Drill amp Burr Attachments AAA 12 RZ 450 Reamer Attachments cccccccccssssesssseseseeeeeeeesssseeeaeeeesseeeeeess 14 SZ 450 Sagittal Saw Attachment 15 NZ 450 Quick Release Sagittal Saw Attachment 16 CZ 450 Reciprocating Saw Attachment 17 CZ 451 Reciprocating Saw Attachment 18 WZ 450 Wire Driver PZ 450 Pin Driver Attachment 19 Section 5 Explanation Of Symbols 222444444 nn 21 Section 6 System Fault Finding 22 Conditions for Transport amp Storage 44uussnssnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 22 Repair and Service Infor
11. mation nenn 23 Guarantee and al tirada aan 23 SECTION 1 GENERAL INSTRUCTIONS Warnings amp Safety Rules Failure to follow these instructions may result in serious injury to the patient or operating staff Do not attempt to use the equipment until all the instructions have been studied and understood Never permit untrained personnel to use this instrument system Always operate the instrument at the correct air pressure as specified in these instructions Always ensure that the hose is securely connected prior to use Always inspect all equipment and accessories before use Do not use suspect damaged or worn equipment Always ensure accessories are correctly connected to the handpiece before use Always set the instrument mode selector to the SAFE position when changing accessories or when not in use Always use eye protection when cutting to prevent injury from flying debris Do not allow loose articles to be caught by the moving parts of the instrument Never drop the instrument or it s accessories always handle with extreme care Always allow the instrument to stop before removing from the surgical site Only permit trained personnel to reprocess clean and sterilize this equipment Do not immerse the instrument in fluids Always use Stericut or De Soutter Medical approved accessories Never reuse items marked for single use risks if reused include Cross contamination between patients Bone necrosis due to extra hea
12. ns Set Trigger Mode Selector to Forward or Reverse Refer to Lubrication section of manual Check air supply pressure at regulator bottled air only Check hose for possible restriction Check air supply regulator Retry attachment assembly Clean with small brush Replace the accessory Do not force a damaged accessory into the attachment Replace accessory e H any problem persists then contact De Soutter Medical Ltd 22 Conditions for Transport amp Storage Temperature 20 C to 40 C Relative Humidity 90 maximum Atmospheric Pressure 1 5 atmospheres maximum Repair amp Service Information All powered instruments and attachments should be periodically checked and cleaned Annual servicing is recommended for normal use Due to the specialist techniques used in the manufacture and maintenance of De Soutter instruments user servicing is not possible For service and repair please contact your nearest De Soutter Medical Authorized Service Centre To return an instrument for repair e Record the serial number of the instrument being returned Enclose a brief statement describing the reason for returning the instrument e Enclose the purchase order number for the instrument if warranty is being claimed It will be helpful to include a contact name e Pack the instrument securely and send to the address below Please ensure that the instrument has been properly decontaminated and sterilized Guarantee
13. ode selector is set to the SAFE position Grip the handpiece and attachment as shown Align the slots on the attachment spigot with the pins in the handpiece Push the attachment fully into the handpiece until the locking ring snaps back into its original position Check that the attachment is locked into the handpiece by gently pulling the attachment away from the handpiece Refer to the diagram Attachment Removal e Ensure that the mode selector is set to the SAFE position Grip the handpiece and attachment as shown Using thumb and forefinger rotate the locking ring When the locking ring reaches full rotation pull the attachment away from the handpiece Do not drop the attachment out of the handpiece Refer to the diagram below 10 SECTION 3 MPZ 450 451 HANDPIECE Controls Trigger Mode Selector The mode selector determines how the instrument can be operated Required Function Trigger Mode Selector on Satety O Safety e TO ee IE Reverse Reverse Depress to run Trigger MPZ 450 only The trigger controls the speed of the speed of the instrument The speed of the instrument increases progressively as the trigger is depressed Refer to the diagram below Trigger Reverse Forward Technical Description and Part Number Details MPZ 450 MPZ 451 Part No 226414 226424 Speed Control Type Trigger Foot Pedal Speed 0 1100 rpm 0 1100 rpm Supplied Accessory
14. of lubricant 3 Lubricate collets chucks and hose connectors using suitable mineral oil Inspection and Ensure the equipment is in good working order Note any unusual sounds Function vibrations or operating speeds If operating difficulties are experienced and Testing are not already covered in these operating instructions refer to the Repair and Servicing Information section of this manual Re useable cutting accessories saw blades drill bits reamer shells etc Inspect for damage and wear Cutting edges should be sharp and free from damage Discard worn or damaged cutting accessories into a suitable sharp s disposal bin Single use accessories Sterile saw blades burrs K wires etc E Accessories marked for single use only must not be re used Dispose of these items in a sharp s bin or other suitable disposal method Packaging Place cleaned equipment into a Sterilisation case If wrapping is used material conforming to EN868 allowing rapid penetration of steam should be used Sterilization Preferred Method e Vacuum steam autoclave Wrapped or Unwrapped minimum 3 minutes 134 C 3 C 0 C 8 minute minimum drying time Other Validated methods e Gravity steam autoclave wrapped 35 minutes at 134 C 3 C 0 C 8 minute minimum drying time e Gravity steam autoclave wrapped 50 minutes at 121 C 3 C 0 C 8 minute minimum drying time Gravity steam autoclave unwrapped 10 min
15. se Release Release Shank Shank Shank Cannulation 4 1mm Diameter RZ 450 Reamer Attachments Chuck Operation Universal Jacobs e Insert the drill bit into the chuck and tighten with the chuck key Hudson Zimmer and AO The Hudson Zimmer and AO reamer chucks operate in the same manner e Pull the chuck sleeve back and insert the reamer shaft Rotate the reamer shaft until it enters the chuck fully LU e Release the chuck sleeve e Check that the reamer is locked in the chuck by pulling it away from the attachment Refer to the diagram below ECH DEE EI 4 Technical Description amp Part Number Details oo 7 3 co CH Part No Cannulation Speed Diameter RZ 450 Jacobs 0 6 4mm 14160 RZ 450 Hudson Zimmer 14170 4 4mm 0 300 rpm RZ 450 AO 14150 Adaptor Chucks Description Universal Hudson AO Drive Jacobs Drive Part Part No Part No No 6 35mm Jacobs Chuck Zimmer Chuck Harris Chuck Not Applicable 5440 7970 10060 5450 6590 Hudson Chuck Trinkle Chuck AO Synthes Quick Release Drill AO Synthes Protec Reamer Chuck DIN 58 809 Reamer Chuck DHS Chuck 10010 5460 6550 SZ 450 Sagittal Saw Attachment with Blade Clamp Nut Blade Clamp Operation Insertion e Rotate the blade clamp anti clockwise with the tool provided e Insert Blade into the blade holder e Rotate the blade clamp
16. secure Removal e Rotate clamp screw anti clockwise to release blade e Gently pull blade from attachment Never operate the attachment without a blade fitted Technical Description and Part Number Details CZ 450 Part No 14220 Blade Hub Type De Soutter Medical S92 Rasp Shank Diameter 1 8 3 17mm Blade Wrench Supplied 9940 For full details of suitable saw blades refer to Stericut data sheets CZ 451 Reciprocating Saw Attachment Blade Clamp Operation Insertion e Grip the instrument and rotate the blade clamp sleeve clockwise e Insert the blade fully into the blade slot e Release the sleeve e Check that the blade is locked in by pulling the blade gently away from the attachment Removal e Grip the instrument and rotate the blade clamp sleeve clockwise e Remove the blade e Release the sleeve Refer to the diagram below Technical Description amp Part Number Details EAN CZ 451 15110 0 7000cpm Blade Shank Type De Soutter Medical S22 For full details of suitable saw blades refer to Stericut data sheets WZ 450 Wire Driver PZ 450 Pin Driver Attachments Wire Pin Driver Controls Actuating Lever Pull the lever back to grip the wire pin Release the lever to release the wire pin Wire Pin Driver Operation Warning The wire pin must be clean before inserting into the instrument even when removing wire pin from a fixation Warning Do not use bent wires pins
17. sing Long narrow cannulations and blind holes require particular attention during cleaning Repeated processing has minimal effect on these instruments End of life is normally determined by wear or damage during use Detergents Only use detergents that are declared by the manufacturer as safe for use on anodised aluminium components Only use detergents with a maximum pH value of 11 0 Ensure the detergent manufacturers guidelines are closely observed Instructions Point of Use Do not operate the equipment while still warm Containment and transportation It is recommended that instruments be reprocessed immediately following surgical use The handling collection and transportation of soiled equipment should be strictly controlled to minimise risks Preparation for Remove all attachments and accessories for cleaning wash separately or cleaning dispose of as per instructions Manual Equipment Cleaning Manual cleaning should only be carried out where automatic washer disinfection is not available It should be conducted in a dedicated area by trained personnel wearing protective clothing e g gloves waterproof apron and goggles or visor Use suitable detergents See note regarding detergents and Nylon scrubbing brushes Dedicated sinks with temperature controlled water ideally de ionized or distilled and a Lint free cloth for drying Method 1 Wash off excess contaminant with running wat
18. t generation Inaccurate cutting Product Description The MPZ system is a modular pneumatic instrument system for small bone and trauma surgery The system consists of MPZ 450 The MPZ 450 Handpiece features a powerful reversible air motor with a trigger operated variable speed control MPZ 451 The MPZ 451 Handpiece features a powerful reversible air motor with the variable speed control operated by a separate foot pedal The Handpiece acts as the power plant for the MPZ system and may be fitted with the following attachments DZ 450 Drill Attachments SZ 450 Sagittal Saw Attachment RZ 450 Reamer Attachments WZ 450 Wire Driver Attachment CZ 450 Reciprocating Saw Attachment PZ 450 Pin Driver Attachment NZ 450 Quick Release Sagittal Saw Attachment Air Supply Use only 99 97 pure dry compressed air or nitrogen filtered to 5 microns Lower pressures may be set for lower speed and torque requirements Monitor the pressure on the pressure gauge at the regulator Operating Pressure 7 bar 100 psi Never exceed 7 bar 100psi pressure Reprocessing Instructions Limitations on reprocessing Do not immerse the equipment in water other than when automatic reprocessing and only then when fitted with the correct washing caps if specified Do not exceed temperatures 140 C Do not clean any part of the equipment in an ultrasonic cleaner Ensure that attachments with collet mechanisms are fully open when reproces
19. utes at 134 C 3 C 0 C 8 minute minimum drying time Storage Wrapping sterilized instruments in accordance with EN868 is recommended to preserve sterility The material should present a barrier to microorganisms and particulate contamination Additional Automated cleaning was validated in accordance with HTM 2030 using an Information automated washer disinfector and Neutral Ph enzymatic detergent Sterilization was validated in accordance with HTM2010 using a 134 C 3 C 0 C vacuum steam autoclave Note Manual cleaning Not validated for reasons of non repeatability The instruction s provided above have been validated by De Soutter Medical Ltd as being capable of preparing a device for re use It remains the responsibility of the reprocessor to ensure that the reprocessing as actually performed using equipment materials and personnel in the reprocessing facility achieve the desired result This normally requires validation and routine monitoring of the process Likewise any deviation by the preprocessor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences Optional Accessories Sterilization Accessories Description Part No Handpiece Washing Cap 9950 Sterilisation Case Complete With Metal Tray 14390 Metal Insert Tray Only 14410 Case tray will contain Quantity MPZ 450 451 Modular Handpiece 1 EPV 200 201 Dedicated Sagittal Saw Handpiec
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