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Guilin Woodpecker Medical Instrument Minipex, Инструкция по эксплуатации

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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. And in such cases, the manufacturer takes no 

responsibility.

This device shall not be exposed to high temperature above 138℃.

Processing limit

The products have been designed for a large number of sterilization cycles. The 

materials used in manufacture were selected accordingly. However with every 

renewed preparation for use, thermal and chemical stresses will result in ageing of 

the products. The maximum number of sterilizations for file clip is 200 times. For lip 

hook and touch probe, it is 1000 times. 

6.1 Initial processing

6.1.1 Processing principles

It is only possible to carry out effective sterilization after the completion of effective 

cleaning and disinfection. Please ensure that, as part of your responsibility for the 

sterility of products during use, only sufficiently validated equipment and product-

specific procedures are used for cleaning/disinfection and sterilization, and that the 

Содержание Minipex

Страница 1: ...Apex locator Minipex Instruction Manual ...

Страница 2: ...t function and operation 11 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 11 For technical data please contact 3 4 12 Statement 3 4 13 EMC Declaration of conformity 3 4 ...

Страница 3: ...supporting equipment of endodontic treatment through the measurement of the length of apical teeth helping dentists to finish the endodontic treatment Features of the device a 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 T...

Страница 4: ...2 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 ...

Страница 5: ...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 1 6 2 Measurement of the tooth length before restoration of post crown ...

Страница 6: ...pment 1 8 2 Degree of protection against electric shock Type BF 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 mode Continous operation 1 9 The main technical specifications 1 9 1 Battery 3 7V 320mAh 1 9 2 Adapter 1...

Страница 7: ...ot represent a distinct length or distance in mm or other linear units It simply indicates the touch probe progression towards the apex foramen 2 4 If the screen bar graph suddenly makes a large movement or immediate display OVER in the upper part of the canal continue slightly towards the apex so the signal returns to normal 2 5 In order to prevent leakage or interference between the root canal a...

Страница 8: ...surement 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 circuits do not impair the measurements be particularly careful with patients fitted with metal crowns or bridges Please confirm the we...

Страница 9: ...2 18 Only the original adapter and lithium battery could be used to this machine 3 Installation of the device 3 1 The Connection of the Measuring Wire 3 1 1 Insert the plug of the measuring wire into the left side socket of the unit Attention a Please be careful to use the device keep it stable and avoid hit Incautious use will lead to the damage or the failure of the machine b Measurement can not...

Страница 10: ...e 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 Make sure the scene of measuring the length of the root canal displayed on the screen The device will shutdown automatically after 5 minutes without operation Picture 4 Picture 5 ...

Страница 11: ...r the measuring wire was damaged should be replaced 3 1 4 Explanations on the interfaces displayed a The screen displays the front region of the apical foramen by bars Please refer to the blue region as showed Picture 6 a b The file has gone to the position near by the apical foramen when the yellow bars displayed Picture 6 b c The file has exceeded the apical foramen when the OVER bars displayed ...

Страница 12: ...e socket on the left of the device properly and insert the AC adapter plug to the adapter socket 3 2 2 During battery charging the battery symbol will blinking then will remain steady when charging is completed 3 2 3 After charging please pull the AC adapter and plug out 3 3 Sound adjustment The device is equipped with an audio indicator which enables monitoring of the progression of the file with...

Страница 13: ...thod 4 1 1 The operation should be according to the manual 4 1 2 The dentists should have the knowledge of teeth position and average length and the skill to operate the device 4 1 3 A fully exposed access cavity to show 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 api...

Страница 14: ...l foramen In this case the measurement result of the length of the root canal will be shorter than its real because of the hypoplasia of the root Picture 8 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 mea...

Страница 15: ...urement 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 f There is a metal crown which has connected to the gingival It will cause inaccuracy when the endo file touches metal crown Picture 13 ...

Страница 16: ...e 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 Picture 14 Because of the angles of X rays sometimes it can t take photo of the apical foramen properly so it can t show the accurate position of the apical foramen 4 2 Instruction 4 2 1 Insert the plug of measuring wire into the socket in the si...

Страница 17: ...e 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 Attention a When grip the root canal with a needle file please grip the upper of the metal part near the root canal at the needle handle If you grip the lower part blade or moving part it will wear the metal part of the file folder and the resin part Pictur...

Страница 18: ...rn file clip and it will make the result of measurement inaccurate d Please reference the Picture 18 a to grip the needle file If as Picture 18 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 the endo file to the reference point incisal edge or ...

Страница 19: ...p 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 The shell and measuring wire should be cleaned by 75 alcohol Attention Avoid the silk screen when cleaning 5 Trouble shooting ...

Страница 20: ...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 reconnect the adapter 4 Change the battery and then reconnect the adapter Display not steady while measuring the measurement result is rather longe...

Страница 21: ...t will display OVER if the endo needle contact the gums Display not steady while measuring the measurement result is rather longer or shorter numerical display irregular If there is still 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 m...

Страница 22: ... there has cysts the length of root canal can t be measured accurately Whether the file clip is not clean or broken Clean the file clip by alcohol or replace it Whether the measuring wire is broken or poor contact Contact the both end of the measuring wire directly it displays icon The length measurement indicator only full display near narrow part of the apical Whether the root canal is occlusive...

Страница 23: ...rge number of sterilization cycles The materials used in manufacture were selected accordingly However with every renewed preparation for use thermal and chemical stresses will result in ageing of the products The maximum number of sterilizations for file clip is 200 times For lip hook and touch probe it is 1000 times 6 1 Initial processing 6 1 1 Processing principles It is only possible to carry ...

Страница 24: ...d rinse away the dirt on the surface of product with pure water or distilled water deionized water 2 Dry the product with a clean soft cloth and place it in a clean tray Note The water used here must be pure water distilled water or deionized water 6 2 Preparation before cleaning Steps Tools tray soft brush clean and dry soft cloth 1 Remove lip hook file clip and touch probe from the measuring wir...

Страница 25: ... the irrigating period is sufficient Do not clean the product with ultrasound It is recommended to use a washer disinfector in accordance with EN ISO 15883 For the specific procedure please refer to the automated disinfection section in the next section Disinfection Note a The cleaning agent does not have to be pure water It can be distilled water deionized water or multi enzyme But please ensure ...

Страница 26: ...rdance with the disinfection cycle in EN ISO 15883 Cleaning and disinfecting steps by using Washer disinfector 1 Carefully place the product into the disinfection basket Fixation of product is needed only when the product is removable in the device The products are not allowed to contact each other 2 Use a suitable rinsing adaptor and connect the internal water lines to the rinsing connection of t...

Страница 27: ... 45 C otherwise the protein will solidify and it is difficult to remove c3 The solution used can be pure water distilled water deionized water or multi enzyme solution etc and only freshly prepared solutions can be used c4 During the use of cleaner the concentration and time provided by manufacturer shall be obeyed The used cleaner is neodisher MediZym Dr Weigert d Disinfection d1 Direct use after...

Страница 28: ...t against the white paper white cloth and then dry the product with filtered dry compressed air maximum pressure 3 bar Until no liquid is sprayed onto the white paper white cloth the product drying is completed 2 It can also be dried directly in a medical drying cabinet or oven The recommended drying temperature is 80 120 and the time should be 15 40 minutes Note a The drying of product must be pe...

Страница 29: ... Packaging Install the disinfected and dried product and quickly package it in a medical sterilization bag or special holder sterile box Note a The package used conforms to ISO 11607 b It can withstand high temperature of 138 C and has sufficient steam permeability c The packaging environment and related tools must be cleaned regularly to ensure cleanliness and prevent the introduction of contamin...

Страница 30: ...he Instruction Manual provided by the equipment manufacturer and follow the instructions c Do not use hot air sterilization and radiation sterilization as this may result in damage to the product d Please use the recommended sterilization procedures for sterilization It is not recommended to sterilize with other sterilization procedures such as ethylene oxide formaldehyde and low temperature plasm...

Страница 31: ...it should be reprocessed before use Notes a The storage environment should be clean and must be disinfected regularly b Product storage must be batched and marked and recorded 6 10 Transportation 1 Prevent excessive shock and vibration during transportation and handle with care 2 It should not be mixed with dangerous goods during transportation 3 Avoid exposure to sun or rain or snow during transp...

Страница 32: ...void the storage in a too hot condition High temperature will shorten the life of electronic components damage battery reshape or melt some plastic 7 1 3 Avoid the storage in a too cold condition Otherwise when the temperature 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 us...

Страница 33: ... 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 After service From the date this equipment has been sold based on the warranty card we will repair this equipment free of charge if there are quality problems Please refer to the warranty card for the warranty period ...

Страница 34: ...facture Manufacturer Type BF applied part ClassⅡequipment Ordinary equipment Recovery Used indoor only Keep dry Power on off Handle with care Sound adjustment serial number Humidity limitation for storage Temperature limitation for storage ...

Страница 35: ...ging 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 ...

Страница 36: ...uct 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 electromagnetic emissions The models M...

Страница 37: ...on 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 Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD lEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV air 8 kV contact...

Страница 38: ...typical commercial or hospital environment If the user of the models Minipex require continued operation during power mains interruptions it is recommended that the models Minipex be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field lEC 61000 4 8 30A m 30A m Power frequency magnetic fields should be at levels characteristic of a typical location in a...

Страница 39: ...rms 150 kHz to 80 MHz 6 Vrms in ISM bands 3 V m 80 MHz to 2 7 GHz 3 8 5 M H z 5 7 8 5 M H z Test specification s for E N C L O S U R E P O R T IMMUNITY to RF wireless communicati on equipment Refer to table 9 of IEC 60601 1 2 2014 P o r t a b l e a n d m o b i l e R F c o m m u n i c a t i o n s equipment should be used no closer to any part of the models Minipex including cables than the recommen...

Страница 40: ...etermined by an e l e c t r o m a g n e t i c s i t e survey a should be less than the compliance level in each frequency range b Interference may occur In the vicinity of equipment marked with the following symbol NOTE I At 80 MHz end 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflect...

Страница 41: ... the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m Recommended separation distances between portable and mobile RF communications equipment and the models Minipex The models Minipex are intended for use in electromagnetic environment in which radiated RF disturbances is controlled The customer or the user of the models Minipex can help prevent electromagnetic interfere...

Страница 42: ...dontitis and tooth length 2 Measurement of the tooth length before restoration of post crown 3 Measurement of the tooth length of transplantation and retransplantation Cautions 1 Cautions User must regard EMC please install and put in service Minipex according to the EMC information provided in the accompanying documents 2 Cautions Portable and mobile RF communications equipment can affect medical...

Страница 43: ...d 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 6 The accessories adapter battery measuring wire file clip of Apex locator Minipex may affect the radiation quantity The original accessories are in complia...

Страница 44: ...ZMN SM 167 V1 8 20200319 ...

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