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Guilin Woodpecker Medical Instrument Minipex Instruction Manual

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Apex locator Minipex
Instruction Manual

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Summary of Contents for Guilin Woodpecker Medical Instrument Minipex

  • Page 1 Apex locator Minipex Instruction Manual...

  • Page 2: Table Of Contents

    Contents 1 Introduction ......................1 2 Notice of installing and using the device ..............5 3 Installation of the device ..................7 4 Product function and operation ................1 1 5 Trouble shooting ....................1 7 6 Cleaning, Disinfection and Sterilization ..............2 1 7 Storage, maintenance and transportation ..............3 0 8 Environmental protection ..................3 1 9 After service ......................3 1 10 Symbol instruction ....................3 2...

  • Page 3: Introduction

    1 Introduction 1.1 Foreword Guilin Woodpecker Medical Instrument Co., Ltd. is a professional manufacturer in researching, developing and producing dental equipment which has a wholesome quality assurance system. There are two brands of WOODPECKER Company: WOODPECKER and DTE. Products include ultrasonic scaler, curing light, apex locator and ultrasurgery, etc.
  • Page 4 1.3 Model and dimensions 1.3.1 Model: Minipex 1.3.2 Dimensions: 70mm (length) × 62mm (width) × 20mm (height) 1.4 Components 1.4.1 Picture of the main unit. ( Picture 1 ) Picture 1...
  • Page 5 Battery Touch probe Picture 2 1.5 Structure Minipex 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.
  • Page 6 1.6.3 Measurement of the tooth length of transplantation and retransplantation. 1.7 Contraindication We do not advise the use of Minipex on patients fitted with pacemakers (or other electrical equipment) or on those patients who are advised not to use the electric equipment (like electric shaver, electric blower) for safety reasons.

  • Page 7: Notice Of Installing And Using The Device

    b) Relative humidity: 30% ～ 75% c) Atmosphere pressure: 70kPa ～ 106kPa 2 Notice of installing and using the device 2.1 Please read the instruction manual carefully before the operation. 2.2 As a safety precaution in order to avoid over-instrumentation, it is recommended to proceed as follows: place the file onto an endodontic ruler, where the apex locator screen indicates ‘00’.
  • Page 8 2.7 In order to confirm the file clip and measuring wire makes good contact, test the wire connecting before each use(See 3.1.3). 2.8 The file clip, lip hook and touch probe 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.

  • Page 9: Installation Of The Device

    to other device which produces electromagnetic interference. Dentists should be cautious about operation under such environment. 2.16 The guarantee is valid for normal usage conditions. Any disassembly will render the guarantee void, the professionals of Woodpecker company will offer the repair service during guarantee period.
  • Page 10 Picture 3(a) Picture 3(b) Picture 3(c) Attention: Be sure not to pull the wire when inserting or pulling out the the measuring wire and the file clip. [Picture 3(b) ] Correct operation showed as in Picture 3(c). 3.1.3 Connection Test a) Press the power switch.
  • Page 11 b) Make sure if the plug of the measuring wire is inserted into the socket correctly. c) Make sure if the file clip and lip hook are connected well to the measuring wire. d) Make the file clip nip the lip hook[as showed in picture 4], the “Connection test ”...
  • Page 12 Picture 7 3.2 Charge the battery When the battery is low, a battery indicator appears on the status bar of the screen. Please recharge the battery when the battery charging prompt icon is blinking. However, it is still functional for several treatments before the device shuts down. 3.2.1 Connect the AC adapter and the socket on the left of the device properly, and insert the AC adapter plug to the adapter socket.

  • Page 13: Product Function And Operation

    successively pressing the “ Sound adjustment” button. When sound level is muted the “ Sound indicator” icon is turned off. At other sound levels the “ Sound indicator” icon remains turned on. 4 Product function and operation 4.1 Usage requirements Apex locator should be precise, repeatable, and easy to operate.
  • Page 14 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.
  • Page 15 d) There is a crack on the tooth root In this case, the crack may cause the electric leakage which will affect the accuracy of measurement [Picture 11]. e) A retreatment to an endo which was filled with gutta-percha. Clean the remaining material in the root canal and fill it with little normal saline before a measurement [Picture 12].
  • Page 16 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 slightly to the side of the root canal crowns.In this case, according to the shooting angle as the belowing pictures show, it will cause illusion that the front tip of the root canal haven’t reached the canal tip.
  • Page 17 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 15]. 4.2.5 Clip the file with file clip, approach to the apex, then there will be continuous alarm when the distance is less than 2mm [Picture 16].
  • Page 18 b) When measuring the length of root canal, please don’t use the metal needle file. If you operate the device without the dentistry glove,it will cause leakage and the result of measurement will be inaccurate.Therefore, please use the resin needle file and remember don’t touch the metal part with finger.

  • Page 19: Trouble Shooting

    length of the tooth. It also can be used with the touch probe instead of file clip, when it is inconvenient to measure the back teeth [Picture 19]. 4.2.7 The components that touch body must be autoclaved under high temperature and high pressure.
  • Page 20 Problems Possible causes Solutions No power and no signal on 1. If the battery is placed correctly? 1. Re-install the battery. the screen after the power on. 2. If the battery with no power? 2. Recharge the battery. 1. If the measuring wire is connected Confirm the measuring wire is plugged The length of the root canal correctly?
  • Page 21 Problems Possible causes Solutions Once the endo needle contact the surface of the root canal which is filled with blood, liquid, it will display “OVER” If the root canal is filled with blood, immediately. In this case, push the needle liquid? to the apical root canal, then the display will be normal, you can measure the...
  • Page 22 Problems Possible causes Solutions Once the needle reached the collateral Whether there is collateral or the tooth or the broken part of the tooth root, root is broken? current measurement will overflow from periodontal ligament, it displays “OVER”. Is it because in addition to the top pulp Use rubber dam to prevent the current chamber, low tooth crown? Or there are flow to gums.

  • Page 23: Cleaning, Disinfection And Sterilization

    6 Cleaning, Disinfection and Sterilization The cleaning, disinfection and sterilization of lip hook, file clip and touch probe are as follow. Unless otherwise stated, they will be hereinafter referred to as “products”. Warnings: The use of strong detergent and disinfectant (alkaline pH>9 or acid pH <5) will reduce the life span of products.
  • Page 24 validated parameters are adhered to during every cycle. Please also observe the applicable legal requirements in your country as well as the hygiene regulations of the hospital or clinic,especially with regard to the additional requirements for the inactivation of prions. 6.1.2 Post-operative treatment The post-operative treatment must be carried out immediately, no later than 30 minutes after the completion of the operation.
  • Page 25 6.3 Cleaning The cleaning should be performed no later than 24 hours after the operation. The cleaning can be divided into automated cleaning and manual cleaning. Automated cleaning is preferred if conditions permit. 6.3.1 Automated cleaning •The cleaner is proved to be valid by CE certificationin accordance with EN ISO 15883.
  • Page 26 6.4 Disinfection Disinfection must be performed no later than 2 hours after the cleaning phase. Automated disinfection is preferred if conditions permit. Automated disinfection-Washer-disinfector ·The washer-disinfector is proved to be valid by CE certification in accordance with EN ISO 15883. ·Use high temperature disinfection function.
  • Page 27 Note: Before use, you must carefully read the operating instructions provided by the equipment manufacturer to familiarize yourself with the disinfection process and precautions. b) With this equipment, cleaning, disinfection and drying will be carried out together. c) Cleaning: (c1) The cleaning procedure should be suitable for the product to be treated.
  • Page 28 with the European Pharmacopoeia or the United States Pharmacopoeia). f) After cleaning, the chemical residue should be less than 10mg / L. g) The air used for drying must be filtered by HEPA. h) Regularly repair and inspect the disinfector. 6.5 Drying If your cleaning and disinfection process does not have an automatic drying function, dry it after cleaning and disinfection.
  • Page 29 disinfection, the entire cleaning/disinfection process must be repeated. 2.Check the product. If it is obviously damaged, smashed, detached, corroded or ruptured, it must be scrapped and not allowed to continue to be used. 3.Check the product. If the accessories are found to be damaged, please replace it before use.
  • Page 30 comply with EN ISO 17665; 2.The highest sterilization temperature is 138 ° C; 3.The sterilization time is at least 4 minutes at a temperature of 132 ° C / 134 ° C and a pressure of 2.0 bar ~ 2.3 bars. 4.Allow a maximum sterilization time of 20 minutes at 134 °C.
  • Page 31 The procedure used here is to perform steam sterilization through three pre-vacuums. 6.9 Storage 1. Store in a clean, dry, ventilated, non-corrosive atmosphere with a relative humidity of 10% to 93%, an atmospheric pressure of 70 kPa to 106KPa, and a temperature of -20 °C to +55 °C;...

  • Page 32: Storage, Maintenance And Transportation

    • After each use, wipe the surface of the device and the measuring wire with a soft cloth soaked in clean water (distilled or deionized water) or a clean disposable wipe. Repeat the wipe for at least 3 times. 7 Storage, maintenance and transportation 7.1 Storage 7.1.1 This equipment should be stored in a room where the relative humidity is 10% to 93%(non-condensing), atmospheric pressure is 70kPa to106kPa, and the...

  • Page 33: Environmental Protection

    7.3 Transportation 7.3.1 Excessive impact and shake should be prevented 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.

  • Page 34: Symbol Instruction

    10 Symbol instruction Date of manufacture Manufacturer Type BF applied part Class Ⅱ equipment Ordinary equipment Recovery Used indoor only Keep dry Power on / off Handle with care Sound adjustment serial number Humidity limitation for Temperature limitation for storage storage...
  • Page 35 Sound indicator icon Charging prompt icon Over-instrumentation icon Connection test icon Appliance compliance WEEE directive Atmospheric pressure for storage Follow Instructions for Use CE marked product Authorised Representative in the EUROPEAN COMMUNITY...

  • Page 36: For Technical Data, Please Contact

    Guidance and manufacturer’s declaration - electromagnetic emissions The models Minipex are intended for use in the electromagnetic environment specified below. The customer or the user of the models Minipex should assure that it is used in such an environment.
  • Page 37 Guidance & Declaration — electromagnetic immunity The models Minipex are intended for use in the electromagnetic environment specified below. The customer or the user of the models Minipex should assure that It is used in such an environment. IEC 60601 test...
  • Page 38 Guidance & Declaration - Electromagnetic immunity The models Minipex are intended for use in the electromagnetic environment specified below. The customer or the user of the models Minipex should assure that it is used in such an environment.
  • Page 39 150 kHz to 80 MHz 150 kHz to 80 MHz used no closer to any part of the models Minipex, 6 Vrms in ISM bands 6 Vrms in ISM bands including cables, than the...
  • Page 40 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). F i e l d s t r e n g t h s f r o m f i x e d R F t r a n s m i t t e r s , a s d e t e r m i n e d b y a n e l e c t r o m a g n e t i c s i t e...
  • Page 41 If the measured field strength in the location in which the models Minipex are used exceeds the applicable RF compliance level above, the model Minipex should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the models Minipex.
  • Page 42 2. Cautions:Portable and mobile RF communications equipment can affect medical electrical equipment. 3. Use is not specified for the Apex locator Minipex of the adapter, measuring wire, file clip may increase the radiation quantity or reduce the interference ability of the Apex locator system. A list of all cables and maximum lengths of cables is as follows, transducers and other accessories with Guilin Woodpecker Medical Instrument Co., Ltd.
  • Page 43 Emissions or decreased Immunity of Minipex. 5. Minipex should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, Minipex should be observed to verify normal operation in the configuration in which it will be used.
  • Page 44 ZMN-SM-167 V1.8-20200319...

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