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Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287

2 Safety | 2.1 Infection hazard

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2 Safety

The instructions for use are a component of the product and must be read care-
fully prior to use and be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.

2.1 Infection hazard

Patients, users or third parties could be infected by contaminated medical
devices.

Take suitable personal protective measures.

Follow the instructions for using the components.

Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.

Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.

If you deviate from this procedure, it is essential to make sure that the re-
processing is effective.

Reprocess the product and accessories appropriately before disposal.

2.2 Air embolism and skin emphysema

There is a danger that the insufflation of spray can cause air embolisms and
skin emphysema.

Avoid the insufflation of spray in open wounds.

The improper use of the product might lead to emphysema. Emphysema may
arise in extreme individual cases, especially in the presence of pathological gin-
gival pockets (> 3 mm), mucosal lesions, direct skin contact or contact with
soft tissue and/or improper handling.

The powder jet device must be used as briefly as possible.

The PROPHYflex perio tip may be re-used for up to10 times.

After the treatment, unscrew the empty powder container and rinse the
PROPHYFLEX perio tip with air and water for approx. 10 seconds.

For safety reasons, the torque wrench should be placed on the perio tip as
protection against injuries when the is PROPHYflex in the holder.

2.3 Technical condition

A damaged device or components could injure patients, users and third parties.

Only operate devices or components if they are undamaged on the outside.

Check that the device is working properly and is in satisfactory condition
before each use.

Have parts with sites of breakage or surface changes checked by the Ser-
vice.

Observe the following instructions in order to guarantee optimum functioning
and prevent material damage:

The device should be cleaned, serviced and stored in a dry location, accord-
ing to instructions, if it will not be used for a longer period.

Summary of Contents for PROPHYflex 4 Perio Kit

Page 1: ...Instructions for use PROPHYflex 4 Perio Kit 1 011 9403 Refill PROPHYflex perio tip 1 010 0287...

Page 2: ...Distributed by KaVo Dental GmbH Bismarckring 39 D 88400 Biberach Phone 49 7351 56 0 Fax 49 7351 56 1488 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 D 88400 Biberach www kavo com...

Page 3: ...6 1 Preparations at the site of use 15 6 2 Non fixing pre cleaning of the PROPHYflex perio tip 15 6 3 Manual Reprocessing 16 6 3 1 Manual external cleaning 16 6 3 2 Manual internal cleaning 16 6 3 3...

Page 4: ...e contact your local dealer or the KaVo Repair Service directly 49 0 7351 56 1900 service reparatur kavokerr com Target group This document is intended for dentists and their assistants The startup se...

Page 5: ...tation and storage conditions Humidity Protect from moisture Protect from impact HIBC Code Hazard levels The warning and safety notes in this document must be observed to prevent personal injury and m...

Page 6: ...Avoid the insufflation of spray in open wounds The improper use of the product might lead to emphysema Emphysema may arise in extreme individual cases especially in the presence of pathological gin g...

Page 7: ...vice unless these have been ap proved by the manufacturer of the product 2 5 Qualification of personnel Application of the product by users without the appropriate medical training could injure the pa...

Page 8: ...val 20g Perio Powder PROPHYflex perio tip Refill REF 1 010 0287 3 2 1 Index 10x perio tip 1x Wrench 1x Nozzle pin The markings of the PROPHYflex perio tip are based on the WHO index 3 1 Intended use I...

Page 9: ...ding to these regulations the user is required to only use properly operating equipment to comply with the specified intended use to protect himself the patient and third parties from danger to avoid...

Page 10: ...accessories appro priately Dispose of the perio tip like injection needles in a closed container See also 2 6 Reprocessing steps in accordance with ISO 17664 Page 15 4 1 Inserting the adaptor into th...

Page 11: ...tip before each treatment and check if it is seated firmly Before each treatment make sure that the perio tip works properly Note In order to screw it on hold the wrench with 2 fingers in the round g...

Page 12: ...x perio tip 1 010 0287 4 Startup and shut down 4 4 Removing the PROPHYflex perio tip 12 24 Carefully pull the PROPHYflex perio tip out of the wrench Take the adapter off Unscrew the adapter in counter...

Page 13: ...w the container filled with the PROPHYflex Perio Powder onto the PRO PHYflex 4 Settings on the powder jet unit Aim the jet nozzle at a wet washbasin from a distance of approx 20 cm Set the quantities...

Page 14: ...raindication Apical focus Root caries Treatment procedure 1 Introduce the perio tip to the floor of the pocket then pull the perio tip out by 1 2 mm 2 Start up the PROPHYflex with the foot control 3 U...

Page 15: ...ng water any longer and strong corrosion oc curs Use the wrench to remove the PROPHYflex perio tip from the adaptor See also 2 4 4 Removing the PROPHYflex perio tip Page 11 Note Hardened or damaged ad...

Page 16: ...ter non fixating pre cleaning the inside of the device must be subjected to automated cleaning in a cleaning and disinfection unit in accordance with ISO 15883 1 6 3 2 Manual internal cleaning Manual...

Page 17: ...ernal disinfection of the PROPHYflex 4 perio tip is not applicable For effective reprocessing the inside of the device must be subjected to automated cleaning in a cleaning and disinfection unit in ac...

Page 18: ...rial damage Only disinfect in a washer disinfector or manually NOTICE Never reprocess this medical device in an ultrasonic device Malfunction and material damage Clean manually or in a washer disinfec...

Page 19: ...is normally part of the cleaning program of the thermod isinfector Note Please observe the instructions for use of the thermodisinfector In order to prevent impairment of the KaVo medical device make...

Page 20: ...dical device has a maximum temperature resistance up to 138 280 4 F Select a suitable procedure depending on the available autoclave from the fol lowing sterilisation processes Steriliser with triple...

Page 21: ...rom dental suppliers Adapter perio tip 1 011 9400 Key 2 000 0901 Wrench for cannula 3 004 6351 Nozzle pin 0 410 0911 PROPHYflex perio tip Refill 10 pcs 1 010 0287 Cleaning adapter PROPHYflex 4 long 3...

Page 22: ...rary KaVo shall not be liable for defects and their consequences that have arisen or may arise from natural wear improper handling cleaning or maintenance non compliance with operating maintenance or...

Page 23: ......

Page 24: ...1 013 3754 bd 20180209 01 en...

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