KaVo PROPHYflex 3 Instructions For Use Manual
Instructions for use
PROPHYflex 3 - 2018 for Sirona connection -
1.006.9920, - 1.006.9927
Distributed by:
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
Phone +49 (0) 7351 56-0
Fax +49 (0) 7351 56-1488
Manufacturer:
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com
Table of contents
1 User instructions............................................................................................................................................. 5
2 Safety ............................................................................................................................................................. 6
2.1 Infection hazard ..................................................................................................................................... 6
2.2 Air embolism and skin emphysema ....................................................................................................... 6
2.3 Allergic reactions ................................................................................................................................... 6
2.4 Technical condition ................................................................................................................................ 6
2.5 Accessories and combination with other equipment.............................................................................. 7
2.6 Qualification of personnel ...................................................................................................................... 7
2.7 Service and repair.................................................................................................................................. 8
2.8 Protective equipment ............................................................................................................................. 8
2.9 Property damage ................................................................................................................................... 8
3 Product description......................................................................................................................................... 9
3.1 Purpose – Intended use ........................................................................................................................ 9
3.2 Technical data ....................................................................................................................................... 9
3.3 Scope of delivery ................................................................................................................................... 10
3.4 Transportation and storage conditions .................................................................................................. 10
4 Start up and shut down................................................................................................................................... 11
4.1 Mounting the Sirona coupling ................................................................................................................ 11
4.2 Check the pressure................................................................................................................................ 11
4.3 Check O-rings........................................................................................................................................ 12
5 Operation........................................................................................................................................................ 13
5.1 Attaching the medical device ................................................................................................................. 13
5.2 Remove the medical device................................................................................................................... 13
5.3 Filling the powder container................................................................................................................... 13
5.4 Inserting the cannula ............................................................................................................................. 14
5.5 Removing the cannulas ......................................................................................................................... 14
5.6 Instructions for use for PROPHYflex Powder, PROPHYpearls®, PROPHYflex Perio Powder ............. 15
5.6.1 PROPHYflex powder ................................................................................................................ 16
5.6.2 PROPHYpearls ......................................................................................................................... 16
5.6.3 PROPHYflex Perio Powder....................................................................................................... 17
5.6.4 Preparation ............................................................................................................................... 17
5.6.5 Treating the patient ................................................................................................................... 17
6 Troubleshooting.............................................................................................................................................. 18
6.1 Cleaning a blocked cannula................................................................................................................... 18
6.2 Cleaning the main body ......................................................................................................................... 18
7 Reprocessing steps in accordance with ISO 17664 ....................................................................................... 19
7.1 Preparation at the site of use................................................................................................................. 19
7.2 Cleaning................................................................................................................................................. 19
7.2.1 Manual cleaning of the exterior................................................................................................. 19
7.2.2 Automated external cleaning ................................................................................................... 19
7.2.3 Manual cleaning of the inside ................................................................................................... 20
7.2.4 Automated internal cleaning .................................................................................................... 20
7.3 Disinfection ............................................................................................................................................ 20
7.3.1 Manual disinfection of the the exterior ...................................................................................... 21
Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927
Table of contents
3 / 26
7.3.2 Manual disinfection of the interior ............................................................................................. 21
7.3.3 Mechanical disinfection of the exterior and interior................................................................... 21
7.4 Care products and systems - Servicing ................................................................................................. 21
7.5 Packaging .............................................................................................................................................. 22
7.6 Sterilisation ............................................................................................................................................ 22
7.7 Storage .................................................................................................................................................. 22
8 Tools............................................................................................................................................................... 23
9 Terms and conditions of warranty .................................................................................................................. 24
Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927
Table of contents
4 / 26
Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927
1 User instructions
1 User instructions
Dear User
Congratulations on purchasing this KaVo quality product. By following the instructions
below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
Target group
This document is intended for dentists and their assistants. The section on startup is
also intended for service technicians.
General marks and symbols
Refer to the chapter on Safety/Warning symbol
Important information for users and service technicians
Can be steam-sterilised at 134 oC -1 oC / +4 oC (273 oF -1.6 oF / +7.4 oF)
Thermodisinfectable
CE mark (European Community). A product bearing this mark meets the requirements of the applicable EC directive.
Action request
Hazard levels
The warning and safety notes in this document must be observed to prevent personal
injury and material damage. The warning notes are designated as shown below:
DANGER
In cases which – if not prevented – directly lead to death or severe injury.
WARNING
In cases which – if not prevented – could lead to death or severe injury.
CAUTION
In cases which – if not prevented – could lead to minor or moderate injury.
NOTICE
In cases which – if not prevented – could lead to material damage.
5 / 26
Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927
2 Safety | 2.1 Infection hazard
6 / 26
2 Safety
The instructions for use are a component of the product and must be read carefully
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 the initial startup and after each use, reprocess and sterilise the medical
device and accessories accordingly.
▶ Carry out the cleaning and sterilisation as described in the instructions for use.
The procedure has been validated by the manufacturer.
▶ It is essential to ensure the effectiveness of the cleaning and sterilisation in the
case of deviation in procedure.
▶ Prior to disposal, the product and accessories must be appropriately reprocessed
and sterilised.
▶ In the case of injury to soft tissue, do not continue treatment in the oral cavity with
instruments driven by compressed air.
2.2 Air embolism and skin emphysema
There is a danger that the insufflation of spray in open wounds in the surgical area can
cause air embolisms and skin emphysema.
▶ Avoid the insufflation of spray in open wounds in the surgical area.
2.3 Allergic reactions
The added flavourings of the PROPHYflex powder and the PROPHYpearls® can
cause allergic reactions in individual patients.
▶ Interview the patient about possible allergic reactions and select the appropriate
powder.
▶ Use neutral flavoured products, such as PROPHYpearls® neutral or PROPHYflex
Perio Powder for patients who are susceptible to allergies.
2.4 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 Service.
▶ Safety checks may only be performed by trained service personnel.
▶ If you notice any of the following defects on the product or accessories, stop work-
ing and have the service personnel carry out repair work.
Observe the following instructions in order to guarantee optimum functioning and prevent material damage:
Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927
2 Safety | 2.5 Accessories and combination with other equipment
▶ The device should be cleaned, serviced and stored in a dry location, according to
instructions, if it will not be used for a longer period.
2.5 Accessories and combination with other equipment
Use of un-authorised accessories or un-authorised modifications of the device could
lead to injury.
▶ Only use accessories that have been approved for combination with the product
by the manufacturer.
▶ Only use accessories that are equipped with standardised interfaces.
▶ Do not make any modifications to the device unless these have been approved by
the manufacturer of the product.
2.6 Qualification of personnel
Application of the product by users without the appropriate medical training could injure the patients, the users or third parties.
▶ Make sure that the user has read and understood the instructions for use.
▶ Only employ the device if the user has the appropriate medical training.
▶ Observe national and regional regulations.
The improper use of the product might lead to emphysema. Emphysema may arise in
extreme individual cases, especially in the presence of pathological gingival 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.
▶ Place some cream on the patient's lips to prevent the corners of the mouth from
drying out or cracking.
▶ Metal surfaces appearing matte due to the exposure should be treated with tooth
polishing agents.
▶ Polish all tooth surfaces after the treatment. KaVo recommends using the Clean-
ic® polishing paste made by Kerr.
▶ Rinse the patient's mouth after the treatment with water.
The use of the product with PROPHYflex powder can be harmful in the case of patients in need of maintaining a salt-free or low-salt diet or patients with renal insufficiency, chronic diseases of the respiratory system and chronic diarrhoea.
▶ In such cases, check if an alternative treatment with PROPHYpearls® or PRO-
PHYflex PerioPowder is feasible.
The use of the product might lead to discolouration of the teeth. Following the treatment, the teeth are absolutely clean and all of the dental pellicle (cuticula dentis) is removed. The dental pellicle is restored only some 2 to 3 hours later due to the protein
content of saliva. During this time, the teeth are not naturally protected from discolouration.
▶ Tell your patients not to smoke, drink tea or coffee and not to consume any other
discolouring foods for 2 to 3 hours after treatment.
Due to their low water solubility, PROPHYpearls® can accumulate in the amalgam
separator which will then have to be changed more frequently. PROPHYflex has a
high degree of water solubility and therefore does not accumulate in the amalgam
separator and hose lines.
7 / 26
Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927
2 Safety | 2.7 Service and repair
8 / 26
▶ Clean the suction hoses of the treatment centre after every application.
- For this purpose, aspirate approx. 200 ml of water with the tube to be cleaned.
- Make sure that the sliders at the cannula holders of the suction tubes are closed.
▶ Alternatively, use PROPHYflex Powder.
2.7 Service and repair
Repairs, servicing and safety checks may only be performed by trained service personnel. The following persons are authorised to do this:
▪ Service technicians of KaVo branches after the appropriate product training
▪ Service technicians of KaVo authorised dealers after the appropriate product train-
ing
Observe all the following items during servicing work:
▶ Have the service and testing tasks carried out in accordance with the Medical
Product Operator Ordinance.
▶ After servicing, interventions, and repairs of the device and before re-use, the
device must be subjected to safety checks by the service personnel.
▶ Following expiry of the warranty, check the cutter/grinder holding system and
quick stop once a year.
▶ KaVo recommends specifying in-house service intervals where the medical device
is brought to a professional shop for cleaning, servicing and a function check.
Define the service interval depending on the frequency of use.
Cleansers and disinfectants can damage the plastic housing leading to hairline cracks
and other damage which can ultimately lead to hazards.
▶ Have a safety check done on the product every 2 years. For this purpose, send
the product to the KaVo Customer Service Centre Warthausen or a test centre ap-
proved by KaVo.
2.8 Protective equipment
PROPHYflex Powder and other powders may get in the eyes or mouth of the user or
patient during treatment.
▶ Both patient and user have to wear protective goggles during the treatment.
▶ KaVo recommends the use of dust extraction equipment and mouth protection
during the treatment with PROPHYflex.
2.9 Property damage
The use of PROPHYflex Powder and other powders can cause scratches on parts
and/or products with sensitive surfaces. Wiping sensitive surfaces with a cloth can
cause scratches.
▶ Remove fine powder deposits with a dust extraction device.
▶ Use running tap water to rinse residual powder from liquid-insensitive parts.
Loading...