W&H EM-19, Instructions For Use Manual

Page 1: ...Instructions for use Electric motor EM 19 EM 19 LC...

Page 2: ...packaging 5 1 Introduction 6 2 Safety notes 9 3 Product description 12 4 Operation 13 Assembly Removal 14 Test run 15 5 Hygiene and maintenance 16 General notes 16 Limitations on processing 18 Initia...

Page 3: ...enance and Testing 24 Packaging 25 Sterilization 26 Storage 28 6 Servicing 29 7 W H Accessories and spare parts 31 8 Technical data 32 9 Data on electromagnetic compatibility according to IEC EN 60601...

Page 4: ...WARNING risk of injury Symbols in the Instructions for use Caution Federal law restricts this device to sale by or on the order of a dentist physician veterinarian or with the descriptive designation...

Page 5: ...rix Code for product information including UDI Unique Device Identification Data structure in accordance with Health Industry Bar Code Type B applied part not suitable for intracardiac application Dat...

Page 6: ...or to initial use please read the Instructions for use These explain how to use your medical device and guarantee a smooth and efficient operation Observe the safety notes Intended use Electrical driv...

Page 7: ...the manufacturer The manufacturer can only accept responsibility for the safety reliability and performance of the medical device when it is used in compliance with the following directions The medic...

Page 8: ...ould be prepared for use and maintained by staff who have been trained in procedures for infection control personal safety and patient safety Improper use e g through poor hygiene and maintenance non...

Page 9: ...estart Perform a test run each time before using Ensure that it is possible to complete the operation safely should the units or instruments fail Do not twist or kink the motor cable Do not coil it to...

Page 10: ...the risks and benefits Keep the medical device away from implanted systems Do not place the motor on the patient s body Make appropriate emergency provisions and take immediate action on any signs of...

Page 11: ...nufacturerapproved transmission instruments Follow the directions of the manufacturer of transmission instruments with reference to transmission ratio maximum speed and maximum torque Hygiene and main...

Page 12: ...12 Motor sheath Electrical contacts O Ring Motor cable only EM 19 LC 3 Product description...

Page 13: ...13 4 Operation Do not assemble or remove the medical device during operation Connect motor cable Pay attetion to the positioning Verify full engagement...

Page 14: ...emove the medical device during operation Push the transmission instrument onto the medical device and turn it until it engages audibly Verify full engagement Remove the transmission instrument from t...

Page 15: ...t eye level Start the medical device using the attached transmission instrument In the event of operating malfunctions e g vibrations unusual noise or overheating stop the medical device immediately a...

Page 16: ...infection and sterilization Wear protective clothing safety glasses face mask and gloves Remove the transmission instrument from the medical device Use only oil free filtered compressed air with a max...

Page 17: ...mes specified by the manufacturer of the disinfectant Use disinfectants which have been tested and found effective by the Verbund f r Angewandte Hygiene e V VAH Association for Applied Hygiene the ste...

Page 18: ...se and chemical influences due to processing Send worn or damaged medical devices and or medical devices with material changes to an authorized W H service partner Processing cycles We recommend a reg...

Page 19: ...pe the entire surface of the meeical device with disinfectant Note that the disinfectant used during pre treatment is only for personal protection and cannot replace the disinfectant step after cleani...

Page 20: ...ng Do not place the medical device in liquid disinfectant or in an ultrasonic bath Clean the medical device under running tap water 35 C 95 F Rinse and brush off all internal and external surfaces Rem...

Page 21: ...nds wiping down with disinfectant Evidence of the medical device s basic suitability for effective manual disinfection was provided by an independent test laboratory using the disinfectants mikrozid A...

Page 22: ...her disinfectors cleaning agents and or disinfectants Evidence of the medical device s basic suitability for effective automated disinfection was provided by an independent test laboratory using the M...

Page 23: ...23 Ensure that the medical device is completely dry internally and externally after cleaning and disinfection Remove liquid residues using compressed air Hygiene and maintenance Drying...

Page 24: ...ng and disinfection for damage visible residual soiling and surface changes Reprocess any medical devices that are still soiled Sterilize the medical device following cleaning and disinfection Inspect...

Page 25: ...The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method The sterilization package must be large enough for the ste...

Page 26: ...sterilizers The program selected must be suitable for the medical device Recommended sterilization procedures Dynamic air removal prevacuum cycle type B 134 C 273 F for at least 3 minutes 132 C 270 F...

Page 27: ...the CertoClav MultiControl MC2 S09S273 steam sterilizer CertoClav GmbH Traun Dynamic air removal prevacuum cycle type B 134 C 273 F 3 minutes 132 C 270 F 4 minutes Gravity displacement cycle type N 12...

Page 28: ...28 Store sterile goods dust free and dry The shelf life of the sterile goods depends on the storage conditions and type of packaging Hygiene and maintenance Storage...

Page 29: ...tion and safety of the medical device is necessary and should be carried out at least once every three years unless shorter intervals are prescribed by law The periodic inspection covers the complete...

Page 30: ...ating malfunctions immediately contact an authorized W H service partner Repairs and maintenance work must only be undertaken by an authorized W H service partner Ensure that the medical device has be...

Page 31: ...ccessories and spare parts 04363600 Disposable irrigation tubing set 2 2 m 6 pcs 06290600 Hose clips 5 pcs Use only original W H accessories and spare parts or accessories approved by W H Suppliers W...

Page 32: ...Technical data Motor EM 19 EM 19 LC Direction of rotation forward reverse Speed range 200 40 000 rpm Maximum torque at the motor 6 2 Ncm Coolant volume flow at 100 min 90 ml min Maximum power output...

Page 33: ...ient conditions Temperature during storage and transport 40 C to 70 C 40 F to 158 F Humidity during storage and transport 8 to 80 relativ non condensing Temperature during operation 10 C to 35 C 50 F...

Page 34: ...ironment of the specified type and or in accordance with the specifications of the manufacturer This medical device uses RF energy only for its internal functions Therefore its RF emissions are very l...

Page 35: ...riginal W H accessories and spare parts The use of accessories and spare parts not approved by W H can lead to an increased emission of electromagnetic interference or to a reduced resistance against...

Page 36: ...Radiated Emissions CISPR 11 EN 55011 30 MHz 1000 MHz Group 1 Class B Harmonic distortion IEC EN 61000 3 2 Class A Voltage fluctuations and flicker IEC EN 61000 3 3 Immunity to electromagnetic interfer...

Page 37: ...45 1970 2450 MHz 28 V m 5240 5500 5785 MHz 9 V m Electrical fast transient burst IEC EN 61000 4 4 Electrical cables Input and output cables 2 kV 1 kV Surges IEC EN 61000 4 5 Conducted disturbances ind...

Page 38: ...10 Disposal Ensure that the parts are not contaminated on disposal Follow your local and national laws directives standards and guidelines for disposal Medical device Waste electrical equipment Packag...

Page 39: ...or material or manufacturing defects within a warranty period of 24 months from the date of purchase Accessories and consumables are not covered by the warranty We accept no responsibility for damage...

Page 40: ...40 Authorized W H service partners Find your nearest authorized W H service partner at http wh com Simply go to the menu option Service for full details Or simply scan the QR code...

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Page 42: ...Manufacturer Form Nr 50983 AEN Rev 001 18 10 2021 Subject to alterations W H Dentalwerk B rmoos GmbH Ignaz Glaser Stra e 53 5111 B rmoos Austria t 43 6274 6236 0 f 43 6274 6236 55 office wh com wh com...