Eltrac 471
Contents
1. OF ld adi niet 18 10 SPEGIFICATIONS cai a iii 19 1071 Technical data di E 19 10 2 Safety and Performance standards si iiiinnneenennnnnennnennenss 19 10 3 EMG a 5 e 1 E AEE E AE EE A a RE Se ee tee 19 11 ORDERING INFORMATION uuuu cccccssscssceseeecceccsnsseesesueuseanauseesesueeeeansaseseeueeaeauasesesuenauaganeseeseseanas 22 ear L NONIUS ear L NONIUS J 1 Foreword 1 1 Intended User Operator This manual has been written for the owners and operators of the Eltrac 471 lt contains general instructions on operation precautionary practices maintenance and parts information In order to maximize the use efficiency and lifespan of your unit please read this manual thoroughly and become familiar with the controls as well as the accessories before operating the unit This device is designed to only be used by or under the supervision of persons using the medical device in the course of their work and in the framework of a professional healthcare activity who understand the benefits and limitations of electrotherapy and ultrasound therapy l e professional users WARNING USA only The Eltrac 471 is a prescription device that should only be used under the supervision or by the order of a physician or other licensed healthcare provider Specifications put forth in this manual were in effect at the time of publication However owing to Enraf Nonius her policy of continual improvement changes to these spec2. from incorrect information provided by its personnel or errors incorporated in this manual and or other accompanying documentation including commercial documentation The opposing party product s user or its representative shall disclaim Enraf Nonius from all claims arising from third parties whatever nature or whatever relationship to the opposing party 2 Product Description The ELTRAC 471 is a computer controlled device for traction therapy This device is intended for use by qualified personnel in physiotherapy rehabilitation and adjacent areas By means of a touch screen interface the device can be operated in a simple way All the popular traction therapies can be selected Pre programmed protocols can be used and manually set therapies can be stored Up to five types of therapy can be sequentially programmed Also during the treatment parameters can be adjusted The motor in the device delivers via the cord and the to be connected accessories the necessary traction to the patient between 15 and 900 Newton The Enraf Nonius accessories which are suitable for use with the Eltrac 471 are used for lumbar and cervical traction 3 Precautionary Instructions In this section general warnings and precautions are listed that you should be aware of when using the Eltrac 471 WARNING e Federal law USA only restricts this device to sale by or on the order of a physician or licensed practitioner This device sho
3. setting will be depicted in a diagram On the left hand side of the screen you see a symbol for the therapy form setting In the case of a sequential programme you will find the sequence of the programmed forms of therapy from top to bottom Adjusting parameters You can adjust the parameters by pressing the relevant button on the right hand side of the screen and using the arrow keys in the next screen Confirm using the tick on the navigation bar In order to browse through all parameters for a therapy form select the relevant symbol on the left hand side NB Not all of the parameters can be adjusted during treatment Diagram The keys in the centre of the treatment screen offer the option to zoom in and out of the depiction or to move across the time line The keys appear when the screen is touched once in the centre After a number of seconds the depiction will automatically return to the current position in the treatment Sequential programming By pressing the key you can add another form of therapy The device will ask you to enter the parameters for this other form of therapy To remove part of a sequential programme you start by selecting the recycle bin on the navigation bar immediately followed by pressing the symbol of the relevant form of therapy in the left hand column Start Pause Stop You start the therapy with the start button on the navigation bar To interrupt t
4. voltages No attempt should be made to disassemble the unit Maintenance and repair should be carried out by authorized personnel only Enraf Nonius will not be held responsible for the results of maintenance or repairs by unauthorized persons 9 4 End of life The Eltrac contains materials that can be recycled and or are noxious to the environment Specialized companies can dismantle the unit and sort out these materials When you dispose of the unit find out about local regulations concerning waste management FUSE 2x T1H250V 10 Specifications 10 1 Technical data Mains voltage 100 240 V Mains frequency 50 60 Hz Maximum power 50 VA Main fuses 2 x T1H250V Dimensions 30 x 34 x 22 cm bxdxh Weight 10 kg Environmental conditions for transport and storage Temperature 10 to 70 C Relative humidity 10 to 90 non condensing Atmospheric pressure 500 to 1060 hPa Environmental conditions for normal use Temperature 10 to 40 C Relative humidity 10 to 90 non condensing Atmospheric pressure 500 to 1060 hPa Technical modifications reserved 10 2 Safety and Performance standards C Eio Medical device classification lla This equipment complies with all essential requirements of the Medical Device Directive 93 42 EEC I Safety class I IEC 60601 1 The unit is equipped with a safety earth and must be connected to a mains plug with earth contact R Type B The leakage current and safety e
5. Eltrac 471 Operating Instructions A Copyright FT l NONIUS 5 Enraf Nonius B V Vareseweg 127 3047 AT Rotterdam The Netherlands Tel 31 0 10 20 30 600 Fax 31 0 10 20 30 699 info enraf nonius nl www enraf nonius com Partnumber 1671751_ 40 September 4 2014 Eltrac Operating Instructions Copyright Enraf Nonius B V ES Vareseweg 127 BNONUS 3047 AT Rotterdam The Netherlands Tel 31 0 10 20 30 600 Fax 31 0 10 20 30 699 ENRAF info enraf nonius nl L NONIUS J www enraf nonius com Part number 1671751_ 40 September 4 2014 TABLE OF CONTENTS 1 AFOREWORD ad di 6 1 1 Intended User Operator mommmcccicccnnninnnnnccc esasa ain anina sa piad oi sak anea diiia iadau aa rasiti inn 6 1 2 Product Liability ccinn iia 6 2 PRODUCT DESCRIPTIO Ni ee a a aaa rana aia 6 3 PRECAUTIONARY INSTRUCTIONS 7 Ax INTENDE D USE e e io 8 4 1 MNCL CATIONS na a tn ee E 8 4 2 Contra indiCatiOnS ii nt Pince 8 5 PACKAGE CONTENTS 0000 ai 9 6 INSTALLATION nn nn td 9 6 1 Connection to mains Supply a Eaa are rrea ra d td nier 9 6 2 Disconnection from MAINS SUPPLY eeeececeeeeeeeeeeeeeeeeeeeeeseseneeeseseeneeseseeeeeseseeneeeseseeneeeeseenenenesenens 9 6 3 Attachment Carabiner hook ss ee 9 6 4 Mounting on the traction frame ss snssnnnnnnnennnnneennnnnennnes 10 7 APPLICATION INFORMATION 0 cccccsececcceccsectecinccedeneteanccventuceseedeandevecqececendeesde
6. Favourites e Manual operation e System settings The button for system settings is located at the top right hand side of the navigation bar 8 2 3 Protocols Eltrac 471 ENRAF NONIUS Los Clinical Protocols Jr Favorites dy Manual Operation Selecting protocols After selecting the Protocols menu in the main menu a list will appear with preprogrammed protocols Scroll through this list using the arrows on the navigation bar Select the required protocol by pressing the relevant button Protocol information For more information about a protocol press the info button on the left hand side of the protocol 8 2 4 Favorites Retrieving favorites After selecting the Favorites in the main menu a list will appear with prestored favorites By selecting the required favorite the treatment screen will appear showing the main parameters of the favorite If required each parameter can be adjusted here see 8 2 6 A programme that requires use of the remote control will be preceded by the remote control symbol Removing favorite To remove a favorite first press the recycle bin and then the favorite you want to remove Favorites ENRAF NONIUS ENRAF NONIUS A Ga Favorite 3 ao ao 8 2 5 Manual Operation Form of therapy After selecting Manual Operation in the main menu the possible forms of therapy appear Depending on the selected form of therapy
7. RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Eltrac471 is used exceeds the applicable RF compliance level above the Eltrac471 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Eltrac471 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE ELTRAC471 The Eltrac471 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Eltrac471 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Eltrac471 as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of m transmitter 150 kH MH MH MH GH W zto80 Z 80 z tot800 800 z to 2 5 Z MHz d 1 17VP d 1 17VP d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be esti
8. arth correspond to standard IEC 60601 1 10 3 EMC details Medical electrical devices such as the Eltrac 471 are subject to special precautions with regard to electromagnetic compatibility EMC and must be installed and commissioned in accordance with the EMC advice given in the instructions for use and accompanying documents Portable and mobile RF communication systems e g mobile phones may interfere with medical electrical devices The Eltrac 471 should only be operated with the original mains cable specified in the list of contents delivered Operating the device with any other mains cable can lead to increased emissions or reduced interference immunity of the device ao ao Guidance and manufacturer s declaration electromagnetic interfernce The Eltrac471 is intended for use in the electromagnetic environment specified below The customer or the user of the Eltrac471 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Eltrac471 uses RF energy only for its internal function Therefore CISPR 11 its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The Eltrac471 is suitable for use in all establishments including CISPR 11 domestic establishments and those directly connected to the public Harmonic emissions Class A low vol
9. arth typical commercial or hospital IEC 61000 4 5 environment Voltage dips lt 5 UT lt 5 UT Mains power quality should be that of a short interruptions gt 95 dip in UT for 0 5 cycle gt 95 dip in UT for 0 5 cycle typical commercial or hospital and voltage environment If the user of the Eltrac471 variations on power supply input lines IEC 61000 4 11 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5s 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5s requires continued operation during power mains interruptions it is recommended that the Eltrac471 be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the AC mains voltage prior to application of the test level Guidance and manufacturer s declaration Electromagnetic immunity The Eltrac 471 is intended for use in the electromagnetic environment specified below The customer or the user of the Eltrac 471 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance Electromagnetic environment leve
10. d when exceeding this limit To ensure safe use a force higher than 200 Newton can be selected only in case it is confirmed this force will not be applied with cervical traction 9 3 Technical Maintenance Electrical safety of the device relies on a properly earthed electrical connection via the power cord It is therefore necessary to have this connection checked annually To ensure continued compliance standard this unit should be adjusted and safety tested once each year Procedures laid down in the service manual should be followed This may be carried out by your supplier or by another agency authorized by the manufacturer It is also recommended that a service history record is maintained In some countries this is even obligatory On request a service manual can be made available containing spare part list descriptions calibration instructions and other information which will assist the user s qualified technical personnel to repair those parts of the equipment which are designated by the manufacturer as repairable ea L NONIUS can L NONIUS 5 A CAUTION e Electrical safety of the device relies on a properly earthed electrical connection via the power cord It is therefore necessary to have this connection checked annually e Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy A WARNING e This unit operates with high
11. he treatment press on the pause button on the navigation bar This button will appear in the place of the start button when the treatment is in progress To continue the treatment press the start button To stop the treatment press the STOP button on the navigation bar This will appear when the treatment is in progress ENRAF NONIUS ENRAF NONIUS 100 ESC gt a ENRAF NONIUS Storing favorites When a treatment screen has been set completely as required the setting can be stored as a favorite As long as the treatment has not been started a Store button is available on the navigation bar Press on the Store button to store your settings Also after termination stopping or pausing of the treatment the treatment remains visible on the screen and can still be stored as a favorite ENRAF NONIUS IT 200 ML Ss ao Naming your favorite Using the keyboard type in the name of your favorite setting Press Y to store your favorite setting under the name entered by you Once stored favourites may be retrieved from the Favourites menu Programming A treatment can be programmed in two ways 1 Start with manual operation and run through the menu until the treatment screen is shown For a sequential programme add multiple forms of therapy 2 Go to favorites and select a previously stored treatment as a basis for a new programme On the treatment screen any parameters can be ad
12. ifications may be made at any time without obligation on the part of Enraf Nonius 1 2 Product Liability A law on Product Liability has become effective in many countries This Product Liability law implies amongst other things that once a period of 10 years has elapsed after a product has been brought into circulation the manufacturer can no longer be held responsible for possible shortcomings of the product To the maximum extent permitted by applicable law in no event will Enraf Nonius or its suppliers or resellers be liable for any indirect special incidental or consequential damages arising from the use of or inability to use the product including without limitation damages for loss of goodwill work and productivity computer failure or malfunction or any and all other commercial damages or losses even if advised of the possibility thereof and regardless of the legal or equitable theory contract tort or otherwise upon which the claim is based In any case Enraf Nonius s entire liability under any provision of this agreement shall not exceed in the aggregate the sum of the fees paid for this product and fees for support of the product received by Enraf Nonius under a separate support agreement if any with the exception of death or personal injury caused by the negligence of Enraf Nonius to the extent applicable law prohibits the limitation of damages in such cases Enraf Nonius cannot be held liable for any consequence resulting
13. justed before storing or starting the treatment Favorites ENRAF NONIUS 8 2 7 System setings Select the pictogram for system settings on the navigation bar of the Home menu On this screen you can set the device on the basis of your personal preferences You can change or adjust various settings Example Language Press the language button and select in the following screen the required language using the arrow keys Press the tick on the navigation bar to confirm Clarity This enables you to change the intensity of the back light Press the home button on the navigation bar to return to the Home menu Eltrac 471 B Clinical Protocols A Favorites W Manual Operation System Settings tt 1 3 Language Force Unit Body Weight Unit ENRAF NONIUS y ENRAF NONIUS 4 UK 8 2 8 Shutting device down Turn off the device with the power switch 9 Maintenance and Troubleshooting 9 1 Cleaning and Disinfection 9 1 1 Cleaning of appartus To clean the unit turn it off and unplug the power supply Clean the unit with a damp cloth Do not use abrasive cleaners A small amount of mild household detergent may be used if needed 9 1 2 Cleaning display panel The display panel has an anti reflection coating and should be cleaned carefully Use a soft and dry cotton cloth or micro fiber tissue to clean the panel To remove fingerprints or grease use a non abrasive glass c
14. l Guidance Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications IEC 61000 4 6 150 kHz to 80 MHz equipment should be used no closer to any part of the Eltrac471 including cables than Radiated RF the recommended separation distance IEC 61000 4 3 3 V m 3 V m calculated from the equation applicable to 80 MHz to 2 5 GHz the frequency of the transmitter Recommended separation distance d 1 17 F d 1 17VP 80 MHz to 800 MHz 2 33VF 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol a NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed
15. leaning agent Apply a small amount of the cleaning agent to a soft cotton cloth and then carefully clean the panel CAUTION e Do not spray the cleaning agent directly on the glass panel e Do not use cleaning agents that contain strong alkalis lye acid detergents with fluoride or detergents with ammonia 9 2 Warning Messages Error Messages and Troubleshooting 9 2 1 Self test When the apparatus is turned on it will first execute a self test When an error is detected this being during the self test as well as during normal operation a pop up screen will appear on the display When the error is displayed all outputs will be disabled When this situation occurs remove all cables and switch the apparatus off and switch it on again When the error re appears stop using the device and contact your supplier 9 2 2 Patient stop switch The patient stop switch must be connected to socket 7 Treatment cannot start unless the patient stop switch is connected The switch should be handed to the patient and its use should be explained Make sure the stop switch can be used by the patient during the whole treatment If it is pressed during treatment the traction force will be reduced to the minimum of 15 N at the maximum change over speed At the same time a buzzer will sound 9 2 3 Threshold cervical traction For cervical traction forces greater than 200 Newton are not suitable When setting the traction force a warning will be issue
16. mated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people ao can L NONIUS 5 11 Ordering information Device 1671901 Eltrac 471 Standard accessories 1471800 1471801 1471806 1671751 3444290 Patient stop switch Fixing knob set of 4 Nylon cord 170 cm with carabiner hook Operating Instructions Eltrac 471 Power cord Optional accessories 5100614 5100613 3450500 3013014 3447624 1471802 3445022 3445021 3445512 1471805 3445038 3445020 Manumed Traction 4 section type 926 Manumed Traction 4 section type 916 Manumed Traction 2 section type 004 Flexi stool grey with separate height adjustment for each leg Padded neck harness complete with spreader bar Pulley for mobile traction frame 2 required Pelvic belt for Manumed Traction Thoracic belt for Manumed Traction Mobile traction frame for cervical traction Wall bar bracket for mounting of Eltrac 471 to wall bars Traction frame for Manumed Traction H L width 430 mm Traction frame Manumed fixed height width 480 mm www enraf nonius com
17. on table Pelvic belt Thoracic belt Flexi stool Fixation clamps 2x a Slide the rolling traction section of the table up against the foldable section and lock it in position b Lay the pelvic belt against the cranial edge of the rolling traction section c Lay the thoracic belt against the caudal edge of the foldable section d Slide the two fixation clamps into the tube underneath the foldable section e Fit the fixation straps to the fixation clamps f Adjust the fixation straps when they are stretched out the thoracic belt still touches the caudal edge of the foldable section g Place the patient in position place the flexi stool and fasten the belts h Attach the carabiner hook of the cord to the pelvic belt i Hand over the patient stop switch to the patient and explain its operation j Release the rolling traction section k Start the treatment If necessary adjust the parameters during treatment m After treatment the patient should have sufficient time to recover 7 2 Cervical traction For cervical traction forces over 200 Newton are not suitable By setting the traction force a warning will be issued when exceeding this To ensure safe use traction force over 200 Newton can only be selected in case it is confirmed not to perform cervical traction 7 3 Cord guidance CAUTION Make sure the cord is guided over the pulley as shown in the left drawing 8 Operating Instructions 8 1 Operato
18. otor in the device delivers via the cord and the to be connected accessories the necessary traction to the patient The Enraf Nonius accessories which are suitable for use with the Eltrac 471 are used for the performance of lumbar and cervical traction 4 1 Indications Lumbar disc herniation Cervical disc herniation Mobility restrictions of lower extremity Low Back Pain Radiculopathy Disfiguring dorsopathies Overload induced cervical pain Spondylosis 4 2 Contra indications General e Ligamentous instability Osteomyelitis Discitis Primary or metastatic bone tumor Spinal cord tumor Severe osteoporosis Untreated hypertension Severe anxiety Clinical signs of myelopathy Inadequate expertise of the practitioner providing the treatment Cervical e Vertebral basilar artery insufficiency e Rheumatoid arthritis and other connective tissue disorder e Midline herniated nucleus pulposus e Acute torticollis Lumbal e Restrictive lung disease or other respiratory disorders ao 5 Package Contents Device 1671901 Eltrac 471 Standard accessories Eltrac 471 1471800 Patient stop switch 1471801 Fixing knobs set of 4 1471806 Nylon cord 170 cm with carabiner hook 1671751 Operating Instructions Eltrac 471 3444290 Power cord 6 Installation 6 1 Connection to mains supply Insert the mains cable into socket 5 and connect it to a wall socket AX CAUTION e Do not place the device in a location where the p
19. ower cord could be tripped over or pulled out during treatment e Do not attempt to use the device if it is not properly grounded Make certain that the device is electrically grounded by connecting it only to a grounded electrical service receptacle conformable with the applicable national and local electrical codes regarding medical environments Turn on the device with push button 4 The device will initialize and perform a self test This may take a while At the end of the self test the device enters the Home menu and is ready for use 6 2 Disconnection from mains supply Turn off the device with push button 4 6 3 Attachment carabiner hook AX CAUTION The cord must be attached to the carabiner hook by means of a knot capable of withstanding considerable traction without coming undone A suitable knot is shown in the figure below ear L NONIUS 5 FA NONIUS 6 4 Mounting on the traction frame The Eltrac 471 may be mounted on different Enraf Nonius traction benches by way of a traction frame Moreover the device may be mounted on the mobile traction frame for cervical traction For mounting instructions please refer to the documentation supplied with the traction frames 7 Application Information 7 1 Operating sequence example As the operating sequence is dependent on the therapy and accessories employed only one example is given Requirements Eltrac 471 and tracti
20. r controls 1 Cord 2 Pulley 3 Display with touch screen 4 Power switch O Device disconnected from mains supply 1 Device connected to mains supply 5 Mains input and mains fuses 6 Type number plate Provides information of the device like type and serial number as well as data on mains voltage and maximum current consumption 7 Connection patient stop switch 8 Connection remote control ao 8 2 Basic Operation Switch on the device as described in paragraph 6 8 2 1 Navigation The following buttons can be displayed on the navigation bar Button Significance Back return to previous screen Continue continue to next screen Home return to Home screen Page number number of pages in multi page menu screens or treatment step number number of treatment steps in sequential protocols n Arrow up Scrolls through pages Arrow down Scrolls through pages Store therapy parameters or a programmed sequential protocol as favourite Delete Pause Interrupt treatment Power will be reduced to zero Start Continue treatment Accept selected option Stop Power reduces till zero Emergency stop Power reduces till zero at maximum speed System settings Remote control is connected gt y FA NONIUS 8 2 2 Home The Home menu provides access to the following functions e Protocols e
21. sure between 500 and 1060 hPa e Do not expose the unit to direct sunlight heat radiated from a heat radiator excessive amounts of dust moisture vibrations and mechanical shocks e Inthe case of ingress of liquids unplug the unit from the mains supply and have it checked by an authorized person see the paragraph on maintenance e Before administering any treatment to a patient you should become acquainted with the operating procedures for each mode of treatment available as well as the indications contra indications warnings and precautions Consult other resources for additional information regarding the application of electrotherapy Follow the instructions in the user manual It is important that you read understand and observe the precautionary and operating instructions TYPE B APPLIED PART According 1EC60601 1 Emergency stop E A Connection for remote control 4 Intended Use The ELTRAC 471 is a computer controlled device for traction therapy This device is intended for use by qualified personnel in physiotherapy rehabilitation and adjacent areas By means of a touch screen interface the device can be operated in a simple way All the popular traction therapies can be selected Pre programmed protocols can be used and manually set therapies can be stored Up to five types of therapy can be sequentially programmed Also during the treatment parameters can be adjusted The m
22. tage power supply network that supplies buildings used for IEC 61000 3 2 domestic purposes Voltage fluctuations Complies flicker emissions IEC 61000 3 3 The device should not be used when placed immediately next to or stacked on top of other devices If operation is necessary when immediately next to or stacked on top of other devices the device should be monitored to ensure it is operating as intended in this arrangement Guidance and manufacturer s declaration electromagnetic immunity The Eltrac471 is intended for use in the electromagnetic environment specified below The customer or the user of the Eltrac471 should assure that it is used in such an environment IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 4 Surge 1 kV line s to line s 1 kV line s to line s Mains power quality should be that of a 2 KV line s to earth 2 kV line s to e
23. uld be used only under the continued supervision of a physician or licensed practitioner e Make certain that the unit is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes You should be aware of the contraindications Do not use force greater than 200N for cervical traction Do not operate the unit in the vicinity less than 2 meters distance of a short wave device The patient must be at all times within sight of the practitioner The device should not be used in so called wet rooms hydrotherapy rooms This device is not suitable for use in the presence of flammable anesthetics mixture with air oxygen or nitrous oxide e This device should be kept out of the reach of children CAUTION e Read understand and practice the precautionary and operating instructions Know the limitations and hazards associated with using any electrical stimulation device Observe the precautionary and operational stickers placed on the unit e Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure e Use the Eltrac 471 only in conjunction with the appropriate accessories from Enraf Nonius BV e This unit should be operated transported and stored at temperatures between 10 and 40 C 50 and 104 F with a relative humidity ranging from 10 90 non condensing and an atmospheric pres
24. veeuseesencearaccertsdesnndessancerss 10 7 1 Operating sequence example ss issnisnnnnneneennnnnenenennnneennnnennneenenns 10 TE Cervical UAC OND raz etn ect ak os ccc cet nn ence A A A 10 TS Cord A ne ane ae aE e Aaaa a A seus eicers sep Anehe Ea eai 10 8 OPERATING INSTRUCTIONS wissececsaccccs cicstcts ici traces se ccceteccissetesacteeeecetecctdenstceecc seed ecneusteeresceceobeceets 11 8 1 Operat r Controls iii ai ais 11 8 2 Basic Operation rires a oka Seaia raaa aeaa Seaain 12 8 2 1 Navigation sse AA ee AAA id a ean 12 8 2 2 HOME nha e A AA a ees ee ee 13 8 2 3 E E E E E E EE E E 13 8 2 4 a e as ea vaca E aa S aE Ea E E ands 13 8 2 5 ENS O A ET 14 8 2 6 Treatment screens ner vente e Anon ann sine aire wie aire ili Aan es 14 8 2 7 System Seti Storia as 16 8 2 8 Sh tting device dOWN issia bases ne nd die LE rod dt 16 9 MAINTENANCE AND TROUBLESHOOTING ccsscccsscesseeseseeeeneeeeeseeeeseaeseseeeeeeeeesseesaseaesnseeeeseeets 17 et 9 1 Cleaning and Disinfection ss ennnnnnnnnnenesnnennnennenss 17 9 1 1 Cleaning of appartus 2252508 trad Attia streets arent 17 9 1 2 Cleaning display Panel cacon REE td 17 4 9 2 Warning Messages Error Messages and Troubleshooting 17 9 2 1 Selina rd tidad tdt 17 9 2 2 Patient Stop Witivi e 17 9 2 3 Threshold cervical traction saisie dass ri tea ean aan e laa dae andre ads at eat ais 17 93 Technical Maintenance aaa didas de 17 9 4 Enh
25. you will be prompted to enter the required parameters Setting of parameters Use the arrow keys on the screen to adjust the parameter Use the tick on the navigation bar to confirm the set value The screen for setting the next parameter appears You can use the back key on the navigation bar to return to the previous parameter Manual Operation ENRAF NONIUS a pr VU Pa y haa static lraction ENRAF NOWIUS tt F Traction Force 195 Y fl Configure by Body Weig ht Setting with body weight You have the option to set the body weight and a percentage to determine the required power To do this press the Setting with body weight key at the bottom of the screen Set the patient s body weight In the next screen you can insert the percentage of the body weight The desired tractive power will be calculated for you The absolute value will be shown when you are in the treatment screen Speed The speed with which the tractive power changes can be set very accurately using the arrow keys Moreover you can use the three pictograms at the bottom of the screen slow medium and fast 25N s When all required parameters have been set you will arrive at the treatment screen 8 2 6 Treatment screen Screen lay out At the right hand side of the treatment screen you will be able to quickly view the main parameter settings In the middle of the screen the treatment
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