Woodpecker CA161 Product Description Download Page 12

桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司

GUILIN WOODPECKER Medical Instrument Co.,LTD.

File No.

ZMN-YF-BK10-01-001-001-1

Version

A

2).The air used for drying must be filtered by HEPA.

3)

The device should be dried in a clean area.

5)The drying temperature should not exceed 137 °C.

Maintenance

维护

1. Functional Test and Visual inspection

功能测试和目视检查

Visually inspect the cleanliness of the Handpiece. Perform Functional test
according to instructions of use. If there is still visible stain on the device after
cleaning, the entire cleaning process must be repeated.
Before packaging and sterilization, make sure that the contra-angle handpiece
has been maintained acc. to manufacturer's instruction.
If the device is obviously damaged, smashed, detached, corroded or bent, it
must be discarded and not allowed to continue to be used.
If the accessories are found to be damaged, please replace it beforeuse.

And the new accessories for replacement must be cleaned, disinfected
and dried.
2. Use lubricant to lubricate the handpiece and dried it prior to sterilization.
Aim the nozzle of lubricant bottle to the air hole at the end of the contra-angle
handpice to inject oil for 1-2 seconds.

Packaging

The contra-angle handpiece should be quickly packaged in a medical
sterilization bag (or special holder, sterile box).
Precautions

1

Only use a legally marketed sterilization pouch;

2

The package should withstand high temperature of 137 °C and has

sufficient steam permeability;

3)

The packaging environment and related tools must be cleaned regularly to

Summary of Contents for CA161

Page 1: ...ece according to ISO 7785 2 and is use to hold and drive rotary instruments for the purposes of rotary processing intended for the endodontic treatment CA161 CA161 RR ISO 7785 2 Remark The figure belo...

Page 2: ...200 rpm 100 2500 rpm Output Torque Range 0 4 5 0 Ncm 0 6 4 2 Ncm Chuck type Push button Gear ratio 6 1 Rotation mode Continuous forward continuous reverse and reciprocating rotation Continuous forward...

Page 3: ...1 Type1 3 CA161 RR 1 Gear ratio 6 1 2 Output Speed Range 100 2500 rpm 3 Output Torque Range 0 6 4 2 N cm 4 Chuck type Push button 5 File shank attachment 2 35mm ISO1797 1 Type1 Table 1 3 Description o...

Page 4: ...2 3 Intended patient Patients who need root canal treatment 3 Operation Principle The Contra angle handpiece is a kind of geared angle handpiece and is use to hold and drive rotary instruments for th...

Page 5: ...ematopoietic system digestive system and endocrine system should be cautious to use this equipment 8 Pregnant women lactating women or women of childbearing age who have a plan of pregnancy should be...

Page 6: ...h force to treatment site 11 Please carry out regular maintenance and inspection 12 If the Contra angle Handpieces has not been used for a period of time before operation please maintain it as per mai...

Page 7: ...Output Speed Range 100 1200 rpm 100 2500 rpm Output Torque Range 0 4 5 0 Ncm 0 6 4 2 Ncm Chuck type Push button Gear ratio 6 1 Rotation mode Continuous forward continuous reverse and reciprocating ro...

Page 8: ...the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide 8 Performance Item Technical requirement Appearance and Structure 1 The outer surface should be flat smooth and tidy wit...

Page 9: ...ece could be capable of being subjected to 250 cycles of sterilizing procedure 250 Preparation at the Point of Use The post operative process must be carried out immediately no later than 30 minutes a...

Page 10: ...nd be difficult to remove 10 40 Cleaning Regarding cleaning disinfection rinsing and drying it is to distinguish between manual and automated reprocessing methods Preference is to be given to automate...

Page 11: ...ector If necessary additional manual drying can be performed through lint free towel Insufflate cavities of instruments by using sterile compressed air If your washer disinfector does not have an auto...

Page 12: ...the device is obviously damaged smashed detached corroded or bent it must be discarded and not allowed to continue to be used If the accessories are found to be damaged please replace it beforeuse And...

Page 13: ...mum sterilization temperature 137 C Flash sterilization is not allowed on lumen instruments Storage Sterilized devices should be stored in a dry clean and dust free environment refer to label and inst...

Page 14: ...reference to previous and similar generations of the device 14 Statement Guilin Woodpecker Medical Instrument Co Ltd is not use of and will not use of the following materials to manufacture the Contr...

Page 15: ...ed 17 GMDN Code Code 38347 Definition A hand held mains electricity AC powered dental device that includes a chuck or collet for attaching a dental endpiece e g drill bit bur reamer saw blade polishin...

Page 16: ...or central system The way of administration of energy or exchanging energy may indirectly injure the tissues in the mouth when misused by operators or device under condition of malfunction The device...

Page 17: ...R Medical Instrument Co LTD File No ZMN YF BK10 01 001 001 1 Version A 20 Conformity assessment procedure Annex IX EU 2017 745 MDR 21 EU Representative Name MedNet EC Rep GmbH Add Borkstrasse 10 48163...

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