Guilin Woodpecker Medical Instrument DTE Dpex I Скачать руководство пользователя страница 26 | Manualshive

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EN ISO 9687:1995
EN 1041:2008
EN ISO 14971:2009
EN ISO 7405:2008
EN ISO 10993-1:2009
EN ISO 10993-5:2009
EN ISO 10993-10:2010

11.2 EMC - Declaration of conformity

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Содержание DTE Dpex I

Страница 1: ......

Страница 2: ...vice 4 1 8 The main technical specifications 5 2 Notice of installing and using the device 5 3 Installation of the device 7 3 1 Battery installation 7 3 2 The Connection of the Measuring Wire 7 3 3 Check the machine by tester 10 3 4 Demonstration function 10 4 Product function and operation 11 4 1 Usage requirements 11 4 2 Instruction 14 5 Trouble shooting 16 6 Cleaning and sterilization 20 ...

Страница 3: ...sportation 20 7 1 Storage 21 7 2 Maintenance 21 7 3 Transportation 21 8 Environmental protection 22 9 After service 22 10 For technical data please contact 22 11 Declaration of conformity 22 12 Symbol instructions 28 13 Statement 29 ...

Страница 4: ...different color 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 accessories of the Dpex I can be autoclaved under the high temperature and high pressure Avoiding cross infection effectively 1 2 Model and dimensions 1 2 1 Model Dpex I 1 2 2 Dimensions 105...

Страница 5: ...2 Picture 1 ...

Страница 6: ...3 Picture 2 1 4 Structure Dpex I is composed of main unit measuring wire lip hooks file clip measuring file etc Measuring wire File clip Lip hook Measuring file Tester Picture 3 ...

Страница 7: ...ot advise the use of Dpex I on patients fitted with pacemakers or other electrical equipment or on those patients who was advised not to use the electric equipment like electric shaver electric blower for safety reasons 1 7 The classification of the device 1 7 1 Internal power device 1 7 2 Type BF device 1 7 3 Device not suitable for being used in the presence of a flammable anesthetic mixture wit...

Страница 8: ...e device 2 1 Please read the instruction manual carefully before the operation 2 2 The file clip lip hook and measuring file are reusable Please make sure they are autoclaved under high pressure and high temperature before each operation The endo files should not be used more than 3 times 2 3 Power Supply 3 pcs of 1 5V LR03 alkaline battery Please change them when their voltage is not enough to su...

Страница 9: ...s or bridges Please confirm the wetness of the endo to ensure the reliability of the measuring If it is confirmed that the endo file hasn t reached the apex yet the data showed on the apex locator is too low please check whether the endo is too dry and confirm it with X ray 2 10 This device have electromagnetic interference the patient or doctor who with a heart pace maker are forbidden to use thi...

Страница 10: ...atteries correctly according to the battery polarity labeled on the shell 3 1 4 Attention Do not invert the anode and cathode 3 1 5 Install the battery cover by pressing its convex part to the concave part of the device 3 2 The Connection of the Measuring Wire 3 2 1 Insert the plug of the measuring wire into the right side socket of the unit Attention a Please be careful to use the device keep it ...

Страница 11: ... pull the wire when inserting or pulling out the measuring wire and the file clip Picture 5 a Correct operation showed as in picture 5 b Picture 5 Picture 6 3 2 3 The Operation Confirmation of the Device Before Use a Press the power switch Make sure the scene of measuring the length of the root canal displayed on the LCD screen The device will shutdown automatically after 5 minutes without operati...

Страница 12: ... picture 8 c A continuous beep sound will be generated during the operation picture 8 a b c 3 2 4 Explanations on the interfaces displayed a The screen displays the front region of the apical foramen by instruction bars Please refer to the white region as showed Picture 8 a b The file has gone to the position near by the apical foramen when the green bars displayed Picture 8 b c The file has excee...

Страница 13: ...isplayed the machine work well as showed in picture 9 3 4 Demonstration function 3 4 1 The demonstration function can show the simulation of file s movement The operation is as bellow 3 4 2 Move away the measuring wire from machine 3 4 3 Press the Power on off button turn on the machine 3 4 4 Press the demonstration function button with one second and then we can enter the demonstration mode 4 4 5...

Страница 14: ...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 on the incisal edge of the anterior tooth or on the spire of the molars For those bridge that s broken obviously this symbol should be on the tooth surface supported by the dentin instead of on the suspended enamel 4 1 7 The acute inflammation surro...

Страница 15: ...e measuring The measurement can be continued when the bleeding is stopped Picture 11 c The tooth crown is broken The tissue of the gingival may reach the cavity of the endo hole at the broken point which will cause inaccurate because of the electronic conduction The measurement can be continued when the crown is fixed by gypsum or other insulators Picture 12 d There is a crack on the tooth root In...

Страница 16: ... metal crown Picture 15 Sometimes the results of the EMR and X rays are not meet each other which is neither the machine is abnormal 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 slightly to the side of the root canal crowns In this case according to the shooting angle as the bellowing picture showe...

Страница 17: ...on The battery is on the left of screen 4 2 2 The 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 4 2 4 Hang the lip hook on the lip make sure it contact the oral mucosa as a reference electrode Picture 17 4 2 5 Clip the file with file clip approach to the apex then there will be c...

Страница 18: ...ore please use the resin needle file and remember don t touch 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 20 a to grip the needle file If as Picture 20 b it can t make the measurement inaccurate and the root needle file s apical will break easily 4 2 6 When the file reaches the apex adjust the...

Страница 19: ...e shooting Phenomena of troubles Possible cause Solutions No power and no signal on the screen after the power on 1 If the battery is placed correctly 2 If the battery is empty 1 Re install the batteries 2 Replace the batteries by new ones The length of the root canal cannot be measured 1 If the measuring wire is connected correctly 2 If the measuring wire is broken Confirm the measuring wire is p...

Страница 20: ... saliva overflowing glued to the crown Blood liquid overflow from the root canal glued to the crown or the tooth neck will cause short circuit then cause the in normal phenomena Cleaning 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 fill with blood liquid it will display OVER immediately In this case push the...

Страница 21: ...dle contact the gums If there is still have pulp in the root canal If there is much pulp left in the root canal the root canal length can t be measured correctly If the needle touched the metal repaired material Once the needle touched the metal repaired material current measurement from the gums to the periodontal tissue loss the screen will display OVER If the adjacent surface has caries Current...

Страница 22: ...ement will overflow from periodontal ligament it display OVER Is it because in addition to the top pulp chamber low tooth crown Or there are residues left Use rubber dam to prevent the current flow to gums Are there cysts apical If there has cysts the length of root canal can t be measured accurately Whether the file clip is not clean or broken Cleaning the file clip by alcohol or replace it Wheth...

Страница 23: ...oot canal Replace the current endo file with a larger one If all above measures do not work please contact us 6 Cleaning and sterilization 6 1 The main unit and the measuring wire can be disinfected with alcohol cotton or disinfected cloth 6 2 Do not use potent chemical cleaning agent etc to clean the equipment It will cause damage to the main unit and the measuring wire 6 3 The file clip lip hook...

Страница 24: ...will be dew that will possibly damage pc 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 equipment with pigments 7 3 Transportation 7 3 1 Excessive impac...

Страница 25: ...s been sold based on the warranty card we will repair this equipment free of charge if it has quality problems please refer to the warranty card for the warranty period 10 For technical data please contact 11 Declaration of conformity 11 1 Product conforms to the following standards EN 60601 1 2006 EN 60601 1 2 2007 EN 60601 1 4 1996 EN 60601 1 6 2007 EN 980 2008 ...

Страница 26: ...23 EN ISO 9687 1995 EN 1041 2008 EN ISO 14971 2009 EN ISO 7405 2008 EN ISO 10993 1 2009 EN ISO 10993 5 2009 EN ISO 10993 10 2010 11 2 EMC Declaration of conformity ...

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Страница 30: ...ested 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 ...

Страница 31: ... Symbol instructions Trademark Consult the accompanying documents Date of manufacture Manufacturer Type BF applied part Used indoor only Power on off Sound adjustment Demonstrate the measurement process Open ...

Страница 32: ...ication and CE certification issued by TüV Rheinland 13 Statement All rights of modifying the product are reserved to the manufacturer without further notice The pictures are only for reference The final interpretation rights belong to GUILIN WOODPECKER MEDICAL INSTRUMENT CO LTD The industrial design inner structure etc have claimed for several patents by WOODPECKER any copy or fake product must t...

Страница 33: ...ZMN WI 04 714 1 4 Edition ...

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