BATTERY DRILL SYSTEM
Contents
1. Description Order of Number REF Battery Drill System with end cap 22 4400 00 Medical Device Mono Block Battery oscillating Saw 22 4410 00 Medical device Medical Long rechargeable battery with extension 22 4415 00 device Medical device Standard rechargeable battery 22 4416 00 Medical device Funnel for inserting rechargeable battery into Battery Drill System 4 807 22 4417 00 No medical device Desktop Charger mono 240 115 V charging time 60 minutes 22 4413 00 22 4414 00 No medical device Desktop Charger dual 240 115 V charging time 60 minutes Three jaw 22 4411 00 22 4412 00 Medical device chuck up to dia 7 0 mm 22 4534 00 Round and triangular shanks With chuck key Reduction gears with AO standard clutch large 22 4450 00 Medical device Speed 0 150 rom Oscillating saw AO connection 22 4550 00 Medical device for saw blades AO connection Sternum saw 22 4455 00 Medical device Quick action chuck for drill wires up to dia 2 5 mm 22 4535 00 Medical device Protection amp guidance sleeve for Kirschner wires 22 4540 00 Medical device AO chuck 22 4536 00 Medical device DIN Chuck Aesculap medullary reamer 22 4537 00 Medical device Harris chuck 22 4538 00 Medical device Hudson chuck 22 4539 00 Medical device Disposal LEIBINGER GmbH amp Co KG will dispose of the Battery Drill System 22 4400 00 and attachments without any environmental contamination in accordance with th2. RITA LEIBINGER MEDICAL User Manual AN El oes BATTERY DRILL SYSTEM Easy to use Ergonomic design Simple compact battery packs with high capacity Small robust drill with an extensive range of attachments Steam sterilisable Intended use The Drill 22 4400 00 is used in bone surgery for drilling and tapping inserting and removing screws and placing Kirschner wires The drill has a cannulated drive shaft so that drill wires can be briefly inserted and fed through the drill diameter of cannulation 3 2mm for safe working The tool holders attachments permit quick and easy chucking of the required tools A choice of chucks and holders attachments ensure compatibility with various tool ranges Warning Only attachments from LEIBINGER GmbH amp Co KG are approved If attachments from other manufacturers are used we will not give any warranty Mixing of components from other manufacturers is not permitted Method of operation The electric motor of the Battery Drill System 22 4400 00 is powered by a rechargeable battery and delivers 0 750 rpm with infinitely variable electronic speed control The Battery Drill System has triggers labeled R and L Lower trigger L double function main switch and reverse rotation Upper trigger R infinitely variable clockwise rotation Press both triggers and regulate the speed with the upper trigger The Battery Drill System switches off automatically if not used for app
3. nickel metal hydride the battery Motor does not run Motor defective No sound when trigger is pressed Send to manufacturer for re Control system defective R or L trigger pressed eae Remark The lower trigger has a double function main switch and re verse rotation upper trigger clockwise Trigger switch defective Gears or friction bearing defective rotation Drill cannot be switched from Solenoid switch trigger defec Reversing function does not Send to manufacturer for re reverse to clockwise rotation tive react pair Control system defective Continuous running or wrong direction of rotation Repairs LEIBINGER GmbH amp Co KG only accepts responsibility for the safety reliability and performance of the Battery Drill System 22 4400 00 if the Battery Drill System 22 4400 00 is used in compliance with the instructions in the User s Manual installation additions adjustments modifications and repairs are carried out by LEIBINGER GmbH amp Co KG or by qualified persons ex pressly authorized by LEIBINGER GmbH amp Co KG Only original spare parts from LEIBINGER GmbH amp Co KG may be used for repairs The operator is required to obtain a list detailing the type and scope of work performed with the company stamp date and signature of the repairer SERVICING We recommend sending the Battery Drill System 22 4400 00 to LEIBINGER GmbH amp Co KG for servicing after a year or after 120 sterilization cycle
4. EMC Manufacturer s certificate issued by LEIBINGER GmbH amp Co KG It is hereby certified that the Chargers 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 have been tested and are interference suppressed in compliance with the EMC provisions of EN60601 1 2 1993 These Chargers 22 4413 00 22 4414 00 or 22 441 1 00 22 4412 00 have been tested in compliance with EN60335 2 29 A11 1998 and conform to Germany s equipment safety regulations GSG for placing into commerce Technical Data Type of equipment Chargers 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 Rated voltage 240 V and 115 V Rated frequency 50 HZ Rated input 14 VA Rated output voltage 12 V Rated output current 1100 mA max Protection class II Degree of protection as per DIN EN 529 IPXO Function The Chargers 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 are controlled and monitored by a microcontroller Irrespective of the charge level of the battery the controller measures the momentary capacity and controls the charging process Notice
5. ce of instruments and accessories If rust forms it may be transferred to other instruments and attachments avoid contact at all costs because it is very dangerous for sterilization Constant use of instruments and attachments constitutes natural wear which shortens the service life correspondingly Instruments and attachments that are used often should be replaced at regular intervals MEASURES TO PREVENT CORROSION 1 Careful laying out of correctly packaged and sterilized instruments before the operation selection according to the type of in tervention Always ensure that the outer packaging is intact and the expiry date has not elapsed 2 Check the sterilization indicator inside the tray to ensure that the contents have been sterilized 3 Arrange the instruments and attachments according to the sequence of use during the operation if any instruments are not needed leave them in the tray only prepare instruments and attachments a short time before the operation 4 Remove blood and other exudates from instruments and attachments during the operation replace instruments and attach ments in their assigned place after use 5 Flush through cannulated instruments to prevent blood and bone powder from drying on 6 Use Ringer s lactate solution or saline solution to clean instruments and accessories but do not immerse them in solutions 7 Start cleaning immediately after the operation instruments and attachments used during the
6. completely 4 DRYING Every instrument and attachment must be completely dried inside and outside to prevent rust formation and malfunctioning A com pressed air system can be used for hollow parts and hinges Please note If the instruments and attachments are to be reused imme diately and sterilized without packaging then drying is not necessary 5 LUBRICATION The joints and all moving parts of instruments and attachments must be cleaned and lubricated after use Only use biological oils and acid free lubricants pure cooking oil is recommended If special instrument oil solutions are used the instruments and attachments can be immersed for a certain period of time With some instrument washing machines the lubrication process is incorporated No rinsing is required after lubrication Remove any excess oil before packaging the instruments and attachments STERILISATION Clean and dry instruments immediately after use Do not use clean agents or disinfectants with strongly acid or alkaline additives e g soda sodium hydroxide solution or acids The gentlest cleaning method is machine mechanical cleaning as already described in the User s Manual ONLY STEAM STERILISE INSTRUMENTS AND ATTACHMENTS TECHNICAL SPECIFICATIONS FOR STERILISATION Before operation check the instruments and attachments are in perfect condition and functioning correctly STERILISER Steam autoclave temperature 121 C to 123 C pressure 15 to17
7. dicated by the arrow Slide the chuck 2 onto the shaft 3 as far as it will go e Release the chuck collar 1 Turn the chuck slightly until it engages in the shaft 3 Check the connection Hold the chuck 4 with your left hand and pull it away from the drill Fault Rectification Clutch does not engage in shaft lt gt If due to dirt clean the clutch if due to damage send to Customer Service ATTACHMENTS FOR BATTERY DRILL SYSTEM 4 807 GB Overview of attachments Order number 1 22 4415 00 2 22 4416 00 3 22 4417 00 4 22 4413 00 22 4414 00 5 22 4411 00 22 4412 00 6 22 4534 00 7 22 4450 00 8 22 4550 00 9 22 4455 00 10 22 4535 00 11 22 4540 00 12 22 4536 00 13 22 4537 00 14 22 4538 00 15 22 4539 00 Description Long rechargeable battery with extension for Battery Drill System 22 4400 00 increased power output Standard rechargeable battery Funnel for inserting Rechargeable Battery 22 4415 00 or 22 4416 00 into Battery Drill System 22 4400 00 to avoid contamination of the Battery Drill System If it is not used there may be a loss of sterility Desktop Charger mono 240V and 115V charging time 60 minutes Please state required voltage when ordering Desktop Charger dual 240V and 115V charging time 60 minutes Please state required voltage when ordering Three jaw chuck 0 5 mm to 7 0 mm capacity for round and triangular shanks incl chuck key Reduction
8. e provisions of MED UMW LEIBINGER GmbH amp Co KG will deal with disposal Key to the symbols Symbol 1 Observe instructions in User s Manual Symbol2 Classification Type BF Symbol 3 Recyclable Symbol 4 CE 1253 in accordance with Directive 93 42 EEC d A se by gt Symbol5 Protection class II device Symbol description R clockwise rotation L reverse rotation OVERVIEW 6 Clockwise rotation 7 Main switch and reverse rotation L Battery Drill Battery Compartment Rechargeable Battery End cap Chuck with Drill Bit 3 Clockwise Rotation Main switch and reverse Rotation To obtain full power from the drill during the surgical operation always use freshly charged batteries NO of WD gt Important Preparation Step 1 Open the end cap 4 by turning in the direction indicated by the arrow Step 2 Insert the rechargeable battery 3 into the battery compartment 2 in the direction shown by the arrow at an angle of not more than 10 to 15 insert gently to avoid damaging the contacts Step 3 Replace the end cap 4 and close it by turning in the direction indicated by the arrow Step 4 Test the drill to ensure it operates properly see Method of operation and Functional check on page 2 Overview of attachments NOTE All the clutches and chucks for the Battery Drill System are mounted in the same way Step 1 Slide the clutch collar 1 in the direction in
9. erformance of the Charger 22 4413 00 22 4414 00 or 22 441 1 00 22 4412 00 and BATTERY 22 4415 00 22 4416 00 if the Charger 22 4413 00 22 4414 00 or 22 441 1 00 22 4412 00 and BATTERY 22 4415 00 22 4416 00 are used in compliance with the instructions in the User s Manual e installation additions adjustments modifications and repairs are carried out by LEIBINGER GmbH amp Co KG or by qualified persons ex pressly authorised by LEIBINGER GmbH amp Co KG Only original spare parts from LEIBINGER GmbH amp Co KG may be used for repairs The operator is required to obtain a list detailing the type and scope of work performed with the company stamp date and signature of the repairer WARNING All equipment must be cleaned before sending for servicing Transport and storage conditions To prevent damage The Charger 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 and BATTERY 22 4415 00 22 4416 00 must be transported in the aluminium case provided which has a special foam insert The same applies for correct storage of this device This device must only be kept in a dry closed place Safety instruction 1 If any fault occurs 2 For transport or storage when not in use 3 Before sending for servicing If for any reason the device is stored or transported differently this may result in damage which is not covered by the manufacturer s or dealer s warranty Transport and storage conditions Electromagnetic compatibility
10. gears with AO standard clutch large Speed 0 150 rom Oscillating saw with AO connection for saw blades Sternum saw Quick action chuck for Kirschner wires dia 0 5 to 3 0 mm Protection amp guidance sleeve for Kirschner wires screws onto Battery Drill System 22 4400 00 Chuck for AO and Aesculap attachments Standard small Chuck for DIN attachments Aesculap medullary reamer Harris chuck Hudson chuck Cleaning disinfection and sterilization of attachments except Rechargeable Battery 22 4415 00 22 4416 00 and Desktop Charger 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 because these products are not categorized as medical devices CLEANING AND DISINFECTION CARE AND MAINTENANCE Care and maintenance are vital to keep the attachments in good condition and fully functional Causes of corrosion with stainless steel used for instruments Corrosion is damage or where that can be caused by a chemical reaction e g due to 1 Damaged surfaces 2 The effect of surgical exudates blood suppuration or bodily secretions in prolonged contact with instruments 3 Excessive exposure to certain solutions saline and iodine solutions chloride and strong acids alkaline solutions and incorrectly used disinfectants 4 Poor water quality when cleaning steam sterilizing or rinsing instruments and attachments e g due to rusty water pipes or penetration of rust and metal particles into steam sterilizers 5 Inadequate maintenan
11. leaning solutions or boiled Always close the cap of the Battery Drill System 22 4400 00 before cleaning CAUTION Machine cleaning and ultrasonic cleaning in thermo disinfectors are not permitted Disinfection is required after every surgical intervention to destroy microorganisms Today health professionals and patients are at constantly increasing risk SO appropriate cleaning and disinfection of these drills and attachments is extremely important If in doubt contact LEIBINGER GmbH amp Co KG and the manufacturer of the disinfectant and cleaning agent used Note Please observe the Instructions for use of attachments with the exception of the Rechargeable Battery 22 4415 00 22 4416 00 and Desktop Charger 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 See the section Cleaning disinfection and sterilization of attachments Sterilisation The Battery Drill System 22 4400 00 with end cap and funnel can be sterilized at up to 2 bar at 134 C in the steam sterilizer It is advisable to place the equipment on a cloth or wrap it in a cloth to prevent external or internal damage To ensure proper sterilization the end cap must be screwed onto the Battery Drill System 4 807 CAUTION The Rechargeable Battery 22 4416 00 may never be sterilized because if it is heated to above 65 it will be irreparably damaged Maintenance The Battery Drill System 22 4400 00 itself requires no maintenance Nevertheless we recommend annual i
12. mp 2 must first flash red for 20 seconds if the BATTERY 22 4415 00 22 4416 00 is depleted After approx 20 seconds it glows steady red to indicate that the battery is being charged When the battery is fully charged the lamp changes to green 4 The charging time for a depleted BATTERY 22 4415 00 22 4416 00 4 is approx 60 minutes The lamp glows green to indicate when charging is complete During charging the Charger 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 and the BATTERY 22 4415 00 22 4416 00 warm up but this does not indicate a fault As soon as the BATTERY 22 4415 00 22 4416 00 is fully charged the lamp glows green 2 Chargers 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 switch off automatically when the BATTERY 22 4415 00 22 4416 00 is fully charged This means that you can leave the BATTERY 22 4415 00 22 4416 00 in the operational Charger 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 for a prolonged period so that it is always charged to full capacity without any risk of overcharging The BATTERY 22 4415 00 22 4416 00 should be checked and recharged before use Fault After inserting BATTERY 22 4415 00 22 4416 00 4 in the charging compartment 3 the charge indicator lamp 2 on the Charger 22 4413 00 22 4414 00 or 22 441 1 00 22 441 2 00 fails to light up FAULT RECTIFICATION Turn the BATTERY 22 4415 00 22 4416 00 4 slightly in the charging compartment 3 the charge indicator lamp 2 on the Charge
13. ng mechanically or manually check carefully which cleaning agent is used with which method Always observe the instructions for dilution and use Recommended pH between 7 0 and 8 5 1 MECHANICAL CLEANING Mechanical cleaning is the preferred method Strictly follow the instructions supplied by the manufacturer of the cleaning machine Prepare the instruments and attachments for mechanical cleaning Multipart instruments and attachments that can be dismantled must be taken apart or opened for cleaning All tips and delicate parts should be cleaned manually Do not overfill wire trays place heavy parts on the bottom of the tray Heavily contaminated parts cannulated instruments and attachments may need soaking and flushing through before they are put in the washing machine 2 ULTRASONIC CLEANING classified as a type of mechanical cleaning Remove excess exudates before placing instruments or attachments in the ultrasonic bath Ultrasonic baths are recommended e g for taps or instruments and attachments with deep grooves Ultrasonic cleaning must be followed by normal rinsing 3 MANUAL CLEANING Requires various nylon brushes blowing tube and nozzle clean compressed air device cleaning agents and solvents as for mecha nical cleaning Observe the manufacturer s instructions for cleaning additives Do not use steel wool or wire brushes Treat anodized aluminium with extreme care Any residues remaining after brushing must be removed
14. nspection This must only be entrusted to the manufacturer or qualified persons authorized by the manufacturer The maintenance interval depends on the number of times the Battery Drill System 22 4400 00 is sterilized Note The battery compartment of the Battery Drill System 22 4400 00 has a watertight cap that also keeps out germs You should therefore regularly inspect the sealing ring on the cap and the sealing surface on the handle Transport and storage conditions To prevent damage The Battery Drill System 22 4400 00 and attachments must be transported in such a way that no damage can occur This particularly means en suring suitable packaging The same attention must be paid to correct storage This device must only be kept in a dry closed place Safety instruction Remove the battery from the Battery Drill System 1 Before sterilization 2 If any fault occurs 3 For transport or storage when not in use 4 Before sending for servicing If for any reason the drill is stored or transported differently this may result in damage which is not covered by the manufacturer s or dealer s warranty Troubleshooting Fault Cause Symptom Rectification Motor runs too slowly or torque NiMH battery is to weak Recharge Battery 22 4415 00 is to low 22 4416 00 Lower trigger not pressed NiMH battery is defective or Inspect Charger 22 4413 00 depleles 22 4414 00 or 22 441 1 00 22 4412 00 If necessary change NiMH
15. ons of rotation Ensure that the attached chuck attachment and the required tool are properly connected to the Battery Drill System and check for correct direction of rotation and smooth running wobble if not correctly connected For this functional check first insert a charged Battery 22 4415 00 or 22 4416 00 into the Battery Drill System Cleaning disinfection sterilisation Cleaning and disinfection Wipe the surfaces immediately after use with a lint free cloth moistened with a cleaning agent or disinfectant or use a disinfectant spray to prevent exudates or other contamination from drying on For this manual wipe down use a cleaning agent or disinfectant approved for surface disinfection under national regulations DGHM German Association of Hygiene and Microbiology Please follow the manufacturer s instructions for correct dilution exposure time etc In the case of heavy contamination the Battery Drill System 22 4400 00 can also be cleaned under running water machine cleaning is not permitted Note Excessive exposure to saline solutions or solutions containing iodine or chloride may cause harmful reactions Damage may also be caused by strong acids and alkaline solutions or incorrectly used disinfectants The quality of the water used for cleaning and rinsing is another possible factor affecting corrosion or surface damage for the drill and attachments The Battery Drill System 22 4400 00 must never be immersed in water or c
16. operation are regarded as conta minated Instruments used on patients with possible infections must be similarly disposed of wipe off any blood bone powder and tissue remnants 8 Clean instruments in a designated place within the surgery department If the instruments are sent directly to the central ste rilization area first cover them up to prevent any risk of contamination for staff or the environment Wear protective clothing when disposing of contaminated instruments and attachments DISMANTLING FOR CLEANING Instruments and attachments with removable parts should be dismantled Keep all screws nuts bolts and other small parts together ensuring it is clear which instrument they belong to The persons responsible for dismantling and reassembling instruments should be appropriately trained Clean the individual parts to remove any remaining blood or bone powder and prevent drying on during sterilization and consequent irreparable damage DISINFECTION When using chemical disinfectants the manufacturer s instructions must be strictly followed but always dilute solutions before use For thermal disinfection with hot water the water must be free of foreign bodies Please note Instruments and attachments made of anodized aluminium should not come into contact with certain disinfectant so lutions or cleaning agents so always check the solution before use to avoid subjecting the metal to a chemical reaction CLEANING Whether cleani
17. psi 1 to 1 2 bar at least 30 minutes in packaged state Ata temperature of 131 C to 133 C and a pressure of 15 to17 psi 1 to 1 2 bar the required exposure time decreases to approx 20 minutes Autoclave with prevacuum during the prevacuum phase the air is evacuated from the chamber before the steam flows in Standard cycle for packaged objects 132 C to 135 C at 27 to 30 psi 2 to 3 bar with a minimum exposure time of 4 to 10 minutes IMPORTANT INFORMATION Before using or sterilising any instruments always check that all parts are functioning correctly IF IT IS SHOWN THAT THIS USER S MANUAL HAS NOT BEEN ADHERED TO ALL WARRANTY RIGHTS SHALL LAPSE Instructions for use of attachments Desktop Chargers 4 814 4 816 Version 28 04 2008 1 Main switch pilot lamp lt gt Switch is alight when the charger is ON 2 Charge indicator lamp lt gt Glows steady red when a depleted RECHARGEABLE BATTERY 22 4415 00 22 4416 00 is being charged 2 Charge indicator lamp lt gt Glows green when RECHARGEABLE BATTERY 22 4415 00 22 4416 00 is fully charged 3 Charging compartment lt gt For inserting the RECHARGEABLE BATTERY 22 4415 00 22 4416 00 in the direction indicated by the arrow 4 Battery lt gt Rechargeable battery 22 4415 00 22 4416 00 Preparing for use Step 2 Insert RECHARGEABLE BATTERY 22 4415 00 22 4416 00 4 into the charging compartment 3 in the direction of the arrow Step 3 The charge indicator la
18. r 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 fails to light up NOTE AND WARNING if there is a power fialure neither of the pilot lamps 1 amd 2 will glow Chargers 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 and BATTERIES 22 4415 00 22 4416 00 are not medical devices and therefore should only be used in closed rooms outside the operating theatre Only use in rooms that are free of dust and moisture IMPORTANT SAFETY INSTRUCTION Only store in the original packaging in a dry closed room Never sterilise the BATTERY 4 809 4 810 or the Charger 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 Only use compatible BATTERIES 22 4415 00 22 4416 00 from LEIBINGER GmbH amp Co KG Combination with other makes is forbidden Do not immerse Charger 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 or BATTERY 22 4415 00 22 4416 00 in liquid Care and maintenance Unplug from the power supply before cleaning Use a damp cloth for cleaning the Charger 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 and BATTERY 22 4415 00 22 4416 00 Do not use cleaning agents Make sure that the contacts of BATTERY 22 4415 00 22 4416 00 are kept free of moisture Similarly protect the charging compartment 3 of the Charger 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 against moisture Never immerse in liquid or clean under flowing water Repair LEIBINGER GmbH amp Co KG only accepts responsibility for the safety reliability and p
19. rox 5 minutes If this happens first press the lower trigger L again and re lease it Then press only the upper trigger R for infinitely variable clockwise rotation For infinitely variable reverse rotation hold down both triggers R and L Specifically reverse rotation is required for procedures such as releasing bone screws and removing Kirschner wires Reverse rotation must be used exclusively for the above mentioned procedures Note The Rechargeable Battery 22 4416 00 may not be sterilized but must be treated with the same care as a Surgical instrument even though it is not categorized as a medical device Preparing for use To use the Battery Drill System 22 4400 00 you require the following items Desktop Charger 22 4413 00 or 22 4411 00 for rapid charging of the Battery 22 4416 00 Rechargeable Battery 22 4416 00 Battery Drill 22 4400 00 e Appropriate attachments for the planned procedure Before using the Battery Drill System for the first time please ensure that you have the necessary attachments You will need the Charger 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 and at least one Battery 22 4415 00 or 22 4416 00 Note Before using the Charger 22 4413 00 22 4414 00 or 22 4411 00 22 4412 00 read the accompanying instruction manual Functional check Before using the Battery Drill System always test it with the appropriate attachments fitted Briefly operate the Battery Drill System in both direc ti
20. s surgical operations WARNING All equipment must be cleaned and sterilized before sending for servicing Technical data Type of equipment Type BF Battery Drill System Mono Block Battery 22 4400 00 oscillating Saw 22 4410 00 Voltage 9 6 V 9 6 V Rated capacity of the Rechargeable Battery 22 4416 00 1 2 Ah 1 2 Ah Speed infinitely adjustable 0 750 rpm 0 14000 rom Max torque 4Nm Weight incl battery 1250 grams 1500 grams Motor output 70 W 70 W Type according to Directive EN 60601 1 2 EN 60601 1 IEC 601 1 MED UMW Degree of protection as per DIN EN 529 gt IP66 IP66 Electromagnetic compatibility EMC Manufacturer s certificate It is hereby certified that the Battery Drill System 22 4400 00 22 4410 00 has been tested and is interference suppressed in compliance with the EMC provisions of EN60601 1 2 This Battery Drill System 22 4400 00 22 4410 00 has been tested by our notified body for a Class ll a product with internal or external energy source as per 93 42 EEC Annex II 3 Tested in accordance with EN 60601 1 IEC 601 1 EN 60601 1 2 DIN EN 60601 1 2 Medical electrical devices e EN 1455 Clinical data evaluation of evidence on the basis of literature and a clinical trial MEDDEV 2 7 1 EN14971 Risk analysis evaluation of risk analysis e Evaluation of the check list of Fundamental Requirements for this medical device Attachments
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