operating instruction cordless drill system - Erbrich
Contents
1. OPERATING INSTRUCTION CORDLESS DRILL SYSTEM Intended use The Drill 14 807 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 erbfich Instrumente GmbH 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 Cordless Drill 14 807 is powered by a rechargeable battery and delivers 0 750 rpm with infinitely variable electronic speed control The Cordless Drill has triggers labelled R and L Lower trigger L double function main switch and reverse rotation Upper trigger R nfinitely variable clockwise rotation Press both triggers and regulate the speed with the upper trigger The Cordless Drill switches off automatically if not used for approx 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 and2. triple function lamp 2 glows red see description in Step 3 Step 2 Insert RECHARGEABLE BATTERY 14 809 or 14 810 4 into the charging compartment 3 in the direction of the arrow Step 3 The charge indicator lamp 2 must first flash red for 20 seconds if the BATTERY 14 809 14 810 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 14 809 14 810 4 is approx 60 minutes The lamp glows green to indicate when charging is complete During charging the Charger 14 814 14 816 and the BATTERY 14 809 14 810 warm up but this does not indicate a fault As soon as the BATTERY 14 809 14 810 is fully charged the lamp glows green 2 Chargers 14 814 and 14 816 switch off automatically when the BATTERY 14 809 14 810 is fully charged This means that you can leave the BATTERY 14 809 14 810 in the operational Charger 14 814 14 816 for a prolonged period so that it is always charged to full capacity without any risk of overcharging The BATTERY 14 810 should be checked and recharged before use Fault After inserting BATTERY 14 809 14 810 4 in the charging compartment 3 the charge indicator lamp 2 on the Charger 14 814 14 816 fails to light up FAULT RECTIFICATION Turn the BATTERY 14 809 14 810 4 slyghtly in the charging compartment 3 the charge indicator lamp 2 on the Charger 14
3. 814 14 816 fails to light up NOTE AND WARNING if there is a power fialure neither of the pilot lamps 1 amd 2 will glow Chargers 14 814 14 816 and BATTERIES 14 809 14 810 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 14 809 14 810 or the Charger 14 814 14 816 Only use compatible BATTERIES 14 809 and 14 810 from enrich Instrumente GmbH Combination with other ma kes is forbidden Do not immerse Charger 14 814 14 816 or BATTERY 14 809 14 810 in liquid 28 Care and maintenance Unplug from the power supply before cleaning Use a damp cloth for cleaning the Charger 14 814 14 816 and BATTERY 14 809 14 810 Do not use cleaning agents Make sure that the contacts of BATTERY 14 809 14 810 are kept free of moisture Similarly protect the charging compartment 3 of the Charger 14 814 14 816 against moisture Never immerse in liquid or clean under flowing water Repair erbrich Instrumente GmbH only accepts responsibility for the safety reliability and performance of the Charger 14 814 14 816 and BAT TERY 14 809 14 810if e the Charger 14 814 14 816 and BATTERY 14 809 14 810 are used in compliance with the instructions in the User s Manual e installation additions adjustments modifications and repa
4. them in solutions 7 Start cleaning immediately after the operation instruments and attachments used during the 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 rilisation 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 sterilisation 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 a
5. L Specifically reverse rotation is required for rocedures such as releasing bone screws and removing Kirschner wires Reverse rotation must be used exclusively for the above mentioned procedures Note The Rechargeable Battery 14 810 does not require sterilisation but must be treated with the same care as a surgical instrument even though it is not categorised as a medical device Preparing for use To use the Cordless Drill 14 807 you require the following items e Desktop Charger 14 814 or 14 816 for rapid charging of the Battery 14 810 e Rechargeable Battery 14 810 e Cordless Drill 14 807 e Appropriate attachments for the planned procedure Before using the Cordless Drill for the first time please ensure that you have the necessary attachments You will need the Charger 14 814 or 14 816 and at least one Battery 14 809 or 14 810 Note Before using the Charger 14 814 or 14 816 read the accompanying instruction manual Functional check Before using the Cordless Drill always test it with the appropriate attachments fitted Briefly operate the Cordless Drill in both direc tions of rotation Ensure that the attached chuck attachment and the required tool are properly connected to the Cordless Drill and check for correct direction of rotation and smooth running wobble if not correctly connected For this functional check first insert a charged Battery 14 810 into the Cordless Drill 18 Cleaning disinfection sterili
6. direction of rotation Repairs erbrich Instrumente GmbH only accepts responsibility for the safety reliability and performance of the Cordless Drill 14 807 if e the Cordless Drill 14 807 is used in compliance with the instructions in the User s Manual e installation additions adjustments modifications and repairs are carried out by erbrich Instrumente GmbH or by qualified persons expressly authorised by efbrich Instrumente GmbH Only original spare parts from erbrich Instrumente GmbH 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 Cordless Drill 14 807 to erbrich Instrumente GmbH for servicing after a year or after 120 sterilisation cycles Surgical operations WARNING All equipment must be cleaned and sterilised before sending for servicing 20 Technical data Type of equipment Type BF Cordless Drill 4 807 Mono Block Battery oscillating Saw 14 808 Rated capacity of the Rechargeable Battery 4 810 Weight incl battery 1250 grams 1500 grams Motor output 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 Electromagnetic compatibility EMC Manufacturer s certificate It is hereby certified that the Cordless Drill 14 807 14 808 has been tested and is interference suppre
7. e to rusty water pipes or pene tration of rust and metal particles into steam sterilisers 5 Inadequate maintenance 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 sterilisation 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 sterilised 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 sterilisation indicator inside the tray to ensure that the contents have been sterilised 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
8. ep 1 Slide the clutch collar 1 in the direction indicated by the arrow e Slide the chuck 2 onto the shaft 3 as far as it will go e Release the chuck collar 1 e Turn the chuck slightly until it engages in the shaft 3 e Check the connection e 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 24 ATTACHMENTS FOR CORDLESS DRILL 14 807 GB Overview of attachments Order number 1 REF 2 REF 3 REF 4 REF 5 REF 6 REF 7 REF 8 REF 9 REF 10 REF 11 REF 12 REF 13 REF 14 REF 15 REF 16 REF 14 809 14 810 14 811 14 814 14 816 14 830 14 834 14 836 14 837 14 842 14 843 14 862 14 864 14 866 14 868 14 870 Description Long rechargeable battery with extension for Cordless Drill 14 807 for increased power output Standard rechargeable battery Funnel for inserting Rechargeable Battery 14 809 or 14 810 into Cordless Drill 14 807 to avoid contamination of the Cordless Drill 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 sta
9. for placing into commerce 29 30 Technical Data Type of equipment Chargers 14 814 and 14 816 Rated voltage 240 V and 115 V Rated frepuency 50 HZ Rated umput 14 VA Rated output voltage 12 V Rated output current 1100 mA max Il Protection class Degree of protection as per DIN EN 529 IPXO Function The Chargers 14 814 and 14 816 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 GB GB Notice
10. irs are carried out by enrich Instrumente GmbH or by qualified persons expressly authorised by efbrich Instrumente GmbH Only original spare parts from erbrich Instrumente GmbH 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 14 814 14 816 and BATTERY 14 809 14 810 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 EMC Manufacturer s certificate issued by ernrich Instrumente GmbH It is hereby certified that the Chargers 14 814 and 14 816 have been tested and are interference suppressed in compliance with the EMC provisions of EN60601 1 2 1993 These Chargers 14 814 and 14 816 have been tested in compliance with EN60335 2 29 A11 1998 and conform to Germany s equipment safety regulations GSG
11. lways check the solution before use to avoid subjecting the metal to a chemical reaction CLEANING Whether cleaning 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 26 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 w
12. ondition and functioning correctly STERILISER Steam autoclave temperature 121 C to 123 C pressure 15 to17 psi 1 to 1 2 bar at least 30 minutes in packaged state At a 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 USERS MANUAL HAS NOT BEEN ADHERED TO ALL WARRANTY RIGHTS SHALL LAPSE 27 Instructions for use of attachments Desktop Chargers 14 814 14 816 Version 28 04 2008 1 Main switch pilot amp lt gt Switch is alight when the charger is ON 2 Charge indicator amp lt gt Glows steady red when a depleted RECHARGEABLE BATTERY 14 809 14 810 is being charged 2 Charge indicator amp lt gt Glows green when RECHARGEABLE BATTERY 14 809 14 810 is fully charged 3 Charging compartment lt gt For inserting the RECHARGEABLE BATTERY 14 809 14 810 in the direction indicated by the arrow 4 Battery lt gt Rechargeable battery 14 809 14 810 Preparing for use Step 1 Plug in power plug at the socket switch on at main switch 1
13. ool or wire brushes Treat anodized aluminium with extreme care Any residues remaining after brushing must be removed 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 sterilised 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 c
14. out any environmental contamination in accordance with the provisions of MED UMW erbrich Instrumente GmbH will deal with disposal Key to the symbols Symbol 1 Observe instructions in User s Manual Symbol 2 Classification Type BF gt gt Symbol 3 Recyclable Symbol 4 CE 1253 in accordance with Directive 93 42 EEC Symbol 5 Protection class ll device Symbol description R clockwise rotation L reverse rotation 22 OVERVIEW 6 Clockwise rotation 7 Main switch and reverse rotation L Cordless Drill Battery Compatment Rechargeable Battery End cap Chuck with Drill Bit 3 Clockwise Rotation Main switch and reverse Rotation NOOR WD a Important To obtain full power from the drill during the surgical operation always use freshly charged batteries 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 23 Overview of attachments NOTE Allthe clutches and chucks for the Cordless Drill system are mounted in the same way e St
15. sation 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 Cordless Drill 4 807 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 Cordless Drill 14 807 must never be immersed in water or cleaning solutions or boiled Always close the cap of the Cordless Drill 14 807 before cleaning CAUTION Machine cleaning and ultrasonic cleaning in thermodisinfectors 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 the
16. se drills and attachments is extremely important If in doubt contact MAT 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 14 809 14 810 and Desktop Charger 14 814 14 816 See the section Cleaning disinfection and sterilisation of attachments Sterilisation The Cordless Drill 14 807 with end cap and funnel can be sterilised at up to 2 bar at 134 C in the steam steriliser 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 sterilisation the end cap must be screwed onto the Cordless Drill 14 807 CAUTION The Rechargeable Battery 14 810 must never be sterilised because if it is heated to above 65 C it will be irreparably damaged Maintenance The Cordless Drill 14 807 itself requires no maintenance Nevertheless we recommend annual inspection This must only be entru sted to the manufacturer or qualified persons authorised by the manufacturer The maintenance interval depends on the number of times the Cordless Drill 14 807 is sterilised Note The battery compartment of the Cordless Drill 14 807 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 19 Transport and storage conditions To preven
17. ssed in compliance with the EMC provisions of EN60601 1 2 This Cordless Drill 14 807 14 808 has been tested by our notified body for a Class Il 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 e EN14971 Risk analysis evaluation of risk analysis e Evaluation of the check list of Fundamental Requirements for this medical device Attachments Cordless Drill with end cap Mono Block Battery oscillating Saw Long rechargeable battery with extension Standard rechargeable battery Funnel for inserting rechageable battery into Cordless Drill 4 807 Desktop Charger mono 240 115 V charging time 60 minutes Desktop Charger dual 240 115 V charging time 60 minutes Three jaw chuck up to dia 7 0 mm Round and triangular shanks With chuck key Reduction gears with AO standard clutch large Speed 0 150 rom Oscillating saw AO connection for saw blades AO connection 14 807 14 808 14 809 14 814 14 14 816 14 14 830 14 834 14 836 14 837 14 842 14 843 14 862 14 864 14 866 14 868 Medical device Medical device Medical device Medical device 21 Disposal erbrich Instrumente GmbH will dispose of the Cordless Drill 14 807 and atttachments with
18. t damage The Cordless Drill 14 807 and attachments must be transported in such a way that no damage can occur This particularly means ensuring 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 Cordless Drill 1 Before sterilisation 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 Motor runs too slowly or torque NiMH battery is to weak Recharge Battery 14 809 is to low 14 810 Lower trigger not pressed NiMH battery is defective or depleted Inspect Charger 14 814 14 816 If necessary change the battery NiMH nickel metal hydride Motor does not run Motor defective No sound when trigger is Send to manufacturer for repair pressed Control system defective R or L trigger pressed Remark Trigger switch defective The lower trigger has a double Gears or friction bearing function main switch and re defective verse rotation upper trigger clockwise rotation Drill cannot be switched from Solenoid switch trigger defec Reversing function does not Send to manufacturer for repair reverse to clockwise rotation tive react Control system defective Continuous running or wrong
19. te required voltage when ordering Three jaw chuck 0 5 mm to 7 0 mm capacity for round and triangular shanks incl chuck key Reduction gears with AO standard clutch large Speed 0 150 rpm 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 Cordless Drill 14 807 Chuck for AO and Aesculap attachments Standard small Chuck for DIN attachments Aesculap medullary reamer Harris chuck Hudson chuck Diamond reamer chuck 25 Cleaning disinfection and sterilisation of attachments except Rechargeable Battery 14 809 14 810 and Desktop Charger 14 814 14 816 because these products are not categorised 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 wear 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 incorrect ly used disinfectants 4 Poor water quality when cleaning steam sterilising or rinsing instruments and attachments e g du
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