Guilin Woodpecker Medical Instrument DTE Скачать руководство пользователя страница 36 | Manualshive

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Guidance & Declaration - Electromagnetic immunity

The model is intended for use in the electromagnetic environment specified belo,w

The customer or the user of the model should assure that it is used in such an

environment.

Immunity test IEC 60601

test level

ComplianceI

level

Electromagnetic environment - guidance

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Содержание DTE

Страница 1: ...Please read this manual before operating Industrial design patent No CN 201130378913 4 Apex locator Instruction Manual ...

Страница 2: ... 7 4 Product function and operation 14 5 Trouble shooting 19 6 Disinfection cleaning and sterilization procedure for the accessories 24 8 Environmental protection 28 9 European authorized representative 28 10 After service 28 11 Symbol instruction 29 12 Statement 30 13 EMC Declaration of conformity 30 ...

Страница 3: ...eth helping dentists to finish the endodontic treatment Features of the device a Equipped with clear bright LCD clear image and different colors indicate the trajectory of the file clearly b Based on advanced multiple frequency network impedance measurement technology and automatic calibrating ensures the measurements are accurate c The File clip Lip hook and Touch probe can be autoclaved under hi...

Страница 4: ...2 1 3 3 Model DPEX V 1 4 Components 1 4 1 Picture of the main unit Picture 1 ...

Страница 5: ...be Battery Adapter Tester Picture 2 1 5 Structure The model is composed of main unit measuring wire lip hooks file clip touch probe adapter etc 1 6 Intended use This equipment applies to the measurements below 1 6 1 Measurement of pulpitis pulp necrosis periapical periodontitis and tooth length ...

Страница 6: ...asons 1 8 The classification of the device 1 8 1 Type of protection against electric shock Class Ⅱequipment 1 8 2 Degree of protection against electric shock Type B applied part 1 8 3 Degree of protection against water shock Ordinary equipment IPX0 1 8 4 Device not suitable for being used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide 1 8 5 Operation mod...

Страница 7: ...tee the safety the work length is clinically obtained by subtracting 0 5 1 mm from the length measured by the Apex locator 2 3 The scales 0 5 1 0 and 2 0 on the screen dial do not indicate that the distance to the apex is 0 5 mm 1 0 mm or 2 0 mm It just reminds the operator that the file is getting close to or away from the apical foramen 2 4 If the screen bar graph suddenly makes a large movement...

Страница 8: ...en low battery indicator flashes 2 11 Please use original components the components made by other companies may cause inaccurate measurement or un measurable 2 12 Avoid the connection between the outside and inside liquid of endodontic during measuring in order to avoid the measuring difference 2 13 Keep endo file and file clip away from any other metal or instruments 2 14 To ensure that short cir...

Страница 9: ...the patient 2 18 Only the original adapter and lithium battery could be used to this machine 2 19 Not to position equipment to make it diffcult to operate the disconnection device 2 20 The adapter must be connected to an appropriate power source in the instructions 2 21 Error in replacing lithium batteries can lead to unacceptable risks so use the original lithium battery and replace the lithium b...

Страница 10: ... the Apex Locator is connected to the Endo Motor please connect the white end with the lip hook and the gray end is suspended Attention Be sure not to pull the wire when inserting or pulling out the the measuring wire and the file clip Picture 4 a Correct operation showed as in picture 4 b 3 1 3 Test the wire connecting Test before each use a Press the power switch Make sure the scene of measuring...

Страница 11: ...asuring wire is damaged should be replaced 3 1 4 Determine the working length a When the indicating bar reaches the position of the dial 0 0 and there is APEX on screen the endo file has reached the anatomical apical foramen On the basis of measured length subtract 0 5 1 0 mm to get the working length Picture 7 a b When the indicating bar reaches the red area OVER it indicates that the endo file h...

Страница 12: ... she works on the tooth Make sure to take an X ray to check the results 3 1 5 Enlarged display of apical foramen Picture 8 Picture 8 3 2 Testing the device by tester Test every two weeks Users can use the tester to check if the device work properly specific operation is as follows a Pulling out the the measuring wire and turn off the device ...

Страница 13: ...uthorized distributor or manufacturer for help 3 3 Connect to compatible Endo Motor Optional 3 3 1Plug one end of the USB line into the USB socket on the right side of the device and connect the other end with compatible Endo Motor as shown in Picture 10 a There is no difference between those two ends As shown in Picture 10 b when the Contra angle icon is lit the Apex locator and Endo Motor can co...

Страница 14: ...y plugged into the USB socket the Apex locator cannot communicate with the Endo Motor After plugging the USB wire into the USB socket please do not drop anything on it and do not hit the USB socket 3 4 Set the Apical Stop between 0 0 and 1 0 by pressing the middle button and the set parameter will be automatically saved When the file reaches the Apical Stop the device will beep continually ...

Страница 15: ...roperly and insert the AC adapter plug to the power socket 3 5 2 When the yellow indicator on it shows the device is charging when the yellow indictor turns to green indicator it shows charging has finished It may take 120minutes for charging 3 5 3 After charging please pull the AC adapter and plug out Attention please don t use the device when it is charging and the operator should be over 2 mete...

Страница 16: ... the pulpal cabin 4 1 4 An X ray photo to show the whole length and root canal of the teeth 4 1 5 The endo file should not be too big nor too small to avoid cutting through the apical foramen 4 1 6 Mark an anatomized symbol on the diseased tooth and memorize it on the case history This symbol should be marked on the health bridge or on the tooth filled integrated The position of the mark should be...

Страница 17: ...eal because of the hypoplasia of the root Picture 12 b Bleeding or the blood overflow from the apical foramen In this case the blood will overflow from the root canal and reaches gingival that the blood and the gingival will be on a conducting state which will cause an inaccurate result while measuring The measurement can be continued when the bleeding is stopped Picture 13 c The tooth crown is br...

Страница 18: ...ingival It will cause inaccuracy when the endo file touches metal crown Picture 17 Picture 15 Picture 16 Picture 17 Sometimes the results of the Apex Locator and X rays do not meet each other which is neither because the machine is not normal nor the photo is incorrect taken The actual position of the apical foramen is different from the anatomical one it is very common that the apical foramen sli...

Страница 19: ...equipment is in the normal condition The equipment shuts down after 5 minutes without use 4 2 3 The volume is adjustable Please press the volume bottom for a setting Picture 19 Picture 20 4 2 4 Hang the lip hook on the lip make sure it contact the oral mucosa as a reference electrode Picture 19 4 2 5 Clip the file with file clip approach to the apex then there will be continuous alarm when the dis...

Страница 20: ... the metal part with finger c Please don t use the worn file clip and it will make the result of measurement inaccurate d Please reference the Picture 22 a to grip the needle file If as Picture 22 b it can t properly measure the length of the root canal due to the improper force and the front of the root canal pin is easy to wear 4 2 6 When the file reaches the apex adjust the rubber piece set on ...

Страница 21: ...t be autoclaved under high temperature and high pressure The shell and measuring wire should be cleaned by 75 alcohol Attention Avoid the silk screen when cleaning 5 Trouble shooting Problems Possible causes Solutions No power and no signal on the screen after the power on 1 If the battery is placed correctly 2 If the battery with no power 1 Re install the battery 2 Recharge the battery ...

Страница 22: ...e measuring wire is broken No sound of alarm If the volume is set at mute Adjust the sound level The charging LED indicator goes out 1 The adapter is not connected well 2 Have used faulty adapter with excessive output 3 The battery is not installed well 4 The battery has been damaged 1 Reconnect the adapter 2 Change the adapter must use the original adapter 3 Reinsert the battery and then reconnec...

Страница 23: ...he crown or the tooth neck will cause short circuit then cause the in normal phenomena Clean the blood and the liquid If the root canal is filled with blood liquid Once the endo needle contact the surface of the root canal which is filled with blood liquid it will display OVER immediately In this case push the needle to the apical root canal then the display will be normal you can measure the leng...

Страница 24: ... measurement from the gums to the periodontal tissue loss the screen will display OVER If the adjacent surface has caries Current measurement flow from caries of the adjacent surface to gums then the root canal length can t be measured correctly Whether there is collateral or the tooth root is broken Once the needle reached the collateral or the broken part of the tooth root current measurement wi...

Страница 25: ...asuring wire is broken or poor contact Contact the both end of the measuring wire directly it displays 3 The length measurement indicator only full display near narrow part of the apical Whether the root canal is occlusive The display will be normal after penetrating the narrow part of apical If the root canal is too dry Wet the root canal with normal saline solution or sodium hypochlorite solutio...

Страница 26: ... as the subsequent uses 6 2 General recommendations The user is responsible for the sterility of the product for the first cycle and each further usage as well as for the usage of damaged or dirty instruments For your own safety please wear personal protective equipment gloves glasses mask Use only disinfecting solution which is approved for their efficacy VAH DGHM listing CE marking FDA approval ...

Страница 27: ...observed on instruments a pre cleaning is recommended by brushing them manually with soft material 2 Rinsing Rinse manually and abundantly the accessories with current water 3 Manual Cleaning clean manually the accessories with an adequate brush preliminary soaked in a clean pre disinfectant solution the file clip mechanism has to be activated during the cleaning process press several times the pu...

Страница 28: ...zation at 134 2 0bar 2 3bar 0 20MPa 0 23MPa 4min The accessories lip hook file clip and touch probe must be sterilized according to the packaging labeling Use fractionated vacuum or gravity less preferred autoclaves according to EN 13060 EN 285 Use validated sterilization procedure according to ISO 17665 1 Respect maintenance procedure of the autoclave device given by the manufacturer Use only the...

Страница 29: ...ture of the equipment increases to a normal level there will be dew that will possibly damage PCB Board 7 2 Maintenance 7 2 1 This device do not include accessories for repair usage the repair should be carried out by authorized person or authorized after service center 7 2 2 Keep the equipment in a dry storage condition 7 2 3 Do not throw beat or shock the equipment 7 2 4 Do not smear the equipme...

Страница 30: ...ted in transportation Lay it carefully and lightly and don t invert it 7 3 2 Don t put it together with dangerous goods during transportation 7 3 3 Avoid solarization and getting wet in rain and snow during transportation 8 Environmental protection Please dispose according to the local laws 9 European authorized representative 10 After service From the date this equipment has been sold based on th...

Страница 31: ... Use Date of manufacture Manufacturer Type B applied part ClassⅡequipment Ordinary equipment Recovery Used indoor only Keep dry Power on off Handle with care Sound adjustment serial number Apical Stop Setting CE marked product Humidity limitation Temperature limitation Atmospheric pressure for storage ...

Страница 32: ... by WOODPECKER any copy or fake product must undertake legal responsibilities 13 EMC Declaration of conformity The device has been tested and homologated in accordance with EN 60601 1 2 for EMC This does not guarantee in any way that this device will not be effected by electromagnetic interference Avoid using the device in high electromagnetic environment Guidance and manufacturer s declaration el...

Страница 33: ...hmentand in establishment directly connected to a low voltage powersupply network which supplies buildings used for domesticpurposes Harmonic emissions IMC 61000 3 2 Glass A Voltage fluctuations flicker emissions IEC 61000 3 Complies Guidance Declaration electromagnetic immunity The model is intended for use in the electromagnetic environment specified below The customer or the user of the model s...

Страница 34: ...e at least 30 Electrical fast transient burst IEC 61000 4 4 2kV for power supply lines 1 kV for Input output lines 2kV for power supply lines 1kV for interco nnecting cable Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line to line 2 kV line to earth 1 kV line to line Mains power quality should be that of a typical commercial or hospita...

Страница 35: ...or 5 sec Mains power quality should be that of a typical commerc1al or hospital environment If the user of the model require continued operation during power mains mterru pt ons t 1s recommended that the model be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels characteristi...

Страница 36: ...del is intended for use in the electromagnetic environment specified belo w The customer or the user of the model should assure that it is used in such an environment Immunity test IEC 60601 test level ComplianceI level Electromagnetic environment guidance ...

Страница 37: ...he transmitter Recommended separation distance d 3 5 V1 XP1 2 d 1 2xP1 2 80 MHz to 800 MHz d 2 3xP1 2 800 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 d Is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less t...

Страница 38: ... which the model is used exceeds the applicable RF compliance level above the model should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the model b Over the frequency range 150 kHz to 80 MHz field srtengths should be less than 3V m Recommended separation distances between portable and mobile RF com...

Страница 39: ... the transmitter manufacturerNOTE I At 80 MHZ and 800 MHZ the separation distance for the higher frequency range appliesNOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected byabsorption and reflection from structures objects and people Recommended separation distances between portable and mobile RF communications equipment and the model Apex locator in th...

Страница 40: ...ecker Medical Instrument Co Ltd claims compliance with the requirements of Emission and Immunity Please use original accessories Serial Number Accessories name Cable length Whether shielding 1 adapter 1 No 2 measuring wire 1 7 No 3 file clip 0 2 No 4 Cautions The use of accessories transducers and cables other than those specified with the exception of transducers and cables sold by Guilin Woodpec...

Страница 41: ...es adapter battery measuring wire file clip of Apex locator the model may affect the radiation quantity The original accessories are in compliance with the requiments of the IEC 60601 1 2 Please use original accessories ...

Страница 42: ...ZMN WI 09 494 V1 3 20191119 ...

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