background image

13

9.1 Processing limit

The Injecting Needle is a one-time use product. But follow the steps to 

clean, disinfect and sterilize before use.

9.2 Initial processing

9.2.1 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 product before use, only sufficiently 

validated equipment and product-specific procedures are used for 

cleaning/disinfection and sterilization, 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.

9.2.2 Post-operative treatment

The post-operative treatment must be carried out immediately, no later 

than 30 minutes after the completion of the operation. The steps are as 

follows:

1.Remove the injection needle , please refer to section 5.2.

2.Remove the remaining Gutta Percha materials in the heating cavity . For 

specific operations, please refer to point 11 in section 1.2.

 

Warnings:

 

The injection needle after surgery cannot be used again.

9.2.3 Preparation before cleaning

Tools: Wrench ,tray, clean and dry soft cloth. The steps are as follows:

1.Installing the injection needle Refer to section 5.2.

2.Squeeze out the Gutta Percha materials in the heating cavity and ensure 

that the Gutta Percha materials injected from the Gutta Percha Injecting 

Needle exceed 30mm.

3.Remove the Gutta Percha Injecting Needle from the handle with the 

wrench provided by guilin woodpecker medical instrument co., LTD. Then 

Put them into a clean tray.

4.Wipe and Clean the surface of Gutta Percha Injecting Needle with 

a clean cloth dipped in cleaning agent until no dirt can be seen on the 

surface. Then dry it with a soft cloth and put them into a clean tray. 

Cleaning agent can be pure water.

Notes:

The pure water temperature should not exceed 45 °C, otherwise the protein 

will solidify and it is difficult to remove.

9.3 Cleaning

The cleaning should be performed no later than 24 hours after the 

operation.The cleaning adopt automated cleaning.

The cleaning procedure are as follows.

Содержание Fi-E

Страница 1: ......

Страница 2: ...cations 7 5 Installation and disassembly method of accessories 7 6 Operation method 8 7 Charging instruction 11 8 Safety precautions 11 9 Cleaning Disinfection Sterilization and Maintenance 12 10 Troubleshooting 17 11 After sales service 18 12 Environment protection 18 13 EMC Declaration of comformity 19 14 Statement 22 ...

Страница 3: ...e classed under the following indications Danger always referred to personal injury warning referred to possible damage to property 1 Product introduction 1 1 Intended use Heat up and soften gutta percha and fill the gutta percha into the root canal after preparation And the applied part is Gutta Percha Injecting Needle 1 2 Diagram of components and control buttons The Fi E is equipped with symmet...

Страница 4: ... as five grids When the battery level is one grid it indicates that the battery is low and needs to be charged in time When the battery level is displayed as a space it indicates that the battery is very low and needs to be charged immediately Note During normal use try not to let the battery level reduced to space status completely no power before charge which will shorten the service life of bat...

Страница 5: ...re are charging status indicators on the charging base When the Hot Melting and Filling Instrument is not placed on the charging base the indicator will flashes in amber and green alternately When the Hot Melting and Filling Instrument is placed on the charging base if the charging is being charged the amber indicator will be on constantly When the battery is full the amber indicator will be off a...

Страница 6: ...g Needle 7 Wrench The wrench is used to tighten the Gutta Percha Injecting Needle and its connection to Hot Melting and Filling Instrument After tighten the Gutta Percha Injecting Needle the needle can be bent to any suitable angle with wrench After pre bending the silver needle you can also put the hexagonal hole on the wrench over the hexagonal sheet of the Gutta Percha Injecting Needle and rota...

Страница 7: ...ndex finger making the operation more convenient c Cordless design for Hot Melting and Filling Instrument effectively broadens the operation space d Sensitive temperature control simple display and convenient operation Press temperature setting button to set suitable working temperature e Five preset temperatures are for option 100 C 120 C 150 C 180 C 200 C Three levels of injection speed are for ...

Страница 8: ...ition Temperature 5 C 40 C Humidity 30 75 Air pressure 70kPa 106kPa 1 8 Storage and transport 1 The device should be handled carefully and lightly Be sure that it is far from the vibration and is installed or kept in a cool dry and ventilated place 2 Do not store the device together with the articles that are combustible poisonous caustic or explosive 3 The device should be stored in a room where ...

Страница 9: ...natural latex and metals such as stainless steel silver copper etc are forbidden to use this device 2 The patient with hemophilia is forbidden to use this device 3 The patients with heart pacemaker are forbidden to use this device 4 The dentists with heart pacemaker are forbidden to use this device 5 Heart disease patients pregnant women and children should be cautious to use the equipment 5 Insta...

Страница 10: ...ot Melting and Filling Instrument 5 4 Removal and replacement of battery When removing the battery press inward on the raised stripes at the end of the handle and then remove the battery When installing the battery align the indicator arrow on the battery with the indicator arrow at the end of the handle then buckle the battery into the handle Hold the end of the end of battery do not press the ra...

Страница 11: ...se the gutta percha Choose suitable gutta percha for the device the diameter of the gutta percha is less than 3mm and the length of the gutta percha is less than 17mm Remove the injecting needle firstly put the gutta percha into the hole at the end of the injecting needle and than screw the injecting needle clockwise outo the handle and tighten it Note 1 only one gutta percha stick can be placed a...

Страница 12: ... function setting interface short press the ON OFF button to adjust the parameters short press the mode button to switch content short press the injecting button to save the set parameters and exit the setting interface to enter normal start up and standby interface The functions that can be set are Set the automatic shutdown time 5 10 minutes adjustable the default is 5 minutes Set the buzzed vol...

Страница 13: ...ssories must be cleaned disinfected and sterilized For details see Chapter 9 7 Charging instruction 7 1 Use corresponding charging base for charging Connect the power adapter to the charging base and connect to power supply And then correctly place the Hot Melting and Filling Instrument in the charging base When the Hot Melting and Filling Instrument is not placed on the charging base the indicato...

Страница 14: ...cha leakage during operation 8 8 Do not use excessive force when pre bending the injection needle to prevent the needle from breaking When the needle is bent or worn the gutta percha flowing ability may be deteriorated and the operator should replace the new needle in time according to the clinical condition 8 9 If the device is not in use for a long time please remove the battery 8 10 If the devi...

Страница 15: ...ing Gutta Percha materials in the heating cavity For specific operations please refer to point 11 in section 1 2 Warnings The injection needle after surgery cannot be used again 9 2 3 Preparation before cleaning Tools Wrench tray clean and dry soft cloth The steps are as follows 1 Installing the injection needle Refer to section 5 2 2 Squeeze out the Gutta Percha materials in the heating cavity an...

Страница 16: ... using Washer disinfector 1 Carefully place the Gutta Percha Injecting Needle the Gutta Percha Injecting Needle Protector the Thermal Protector Cap and the Wrench into the disinfection basket Fixation of product is needed only when the product is removable in the device The product is not allowed to contact each other 2 Start the program 3 After the program is finished remove the product from the ...

Страница 17: ...regularly 9 6 Inspection and maintenance In this chapter we only check the appearance of the product After inspection ensure that there is no problem 1 Check the product If there is still visible stain on the product after cleaning disinfection the entire cleaning disinfection process must be repeated 2 Check the product If it is obviously damaged smashed detached corroded it must be scrapped and ...

Страница 18: ...er sterilization procedures such as ethylene oxide formaldehyde and low temperature plasma sterilization The manufacturer assumes no responsibility for the procedures that have not been recommended If you use the sterilization procedures that have not been recommended please adhere to related effective standards and verify the suitability and effectiveness e Fractional pre vacuum procedure steam s...

Страница 19: ...s low When the device is not used please charge t for 1 hour once a month Warning Equipment and all accessories shall not be maintained during use 9 13 Repair of device This product does not contain self repairing spare parts If there is any abnormality in the equipment please contact our company for maintenance and do not disassemble without authorization With our company s consent we will provid...

Страница 20: ... after connecting to power supply 1 The power supply is not correctly connected 2 The power supply is damaged or the specification doesn t match 3 There are impurities on the contact thimble of charging base 1 Unplug and reconnect 2 Replace the battery 3 Wipe the thimble with alcohol under the premise of power failure The service time after each charging is shortened The battery capacity becomes s...

Страница 21: ...rnal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR11 Class B The model Fi E is suitable for used in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions lEC...

Страница 22: ...s Mains power quality should be that of a typical commercial or hospital environment If the user of the models Fi E requires continued operation during power mains interruptions it is recommended that the models Fi E 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 char...

Страница 23: ...h 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 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 rad...

Страница 24: ...0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W accordable to the transmitter manufacturer NOTE I At 80 MHz and 800 MHz the ...

Страница 25: ...ZMN SM 453 V1 0 20220224 ...

Отзывы: