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 [phone]
Fax [phone]

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

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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

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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

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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.

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Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

2 Safety | 2.7 Service and repair

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▶ 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.

Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

3 Product description | 3.1 Purpose – Intended use

3 Product description

PROPHYflex 3 - 2018 SIRONA black

Mat. no. 1.006.9920

PROPHYflex 3 - 2018 SIRONA violet

Mat. no. 1.006.9927

3.1 Purpose – Intended use

Indications for use:

This medical device is

▪ intended for dental treatment only. All other types of use or modifications of the

product are not permitted and can be hazardous. The medical device is intended

for the following applications: Removal of discolouration and bacterial plaque, or-

thodontics, cleaning prior to fissure sealing, prosthetics, conservative and aes-

thetic dentistry. Please refer also to the Instructions for Use.

▪ A medical device according to relevant national statutory regulations.

Proper use:

According to these regulations, this medical device may only be used for the de­scribed application by a properly trained user. You need to comply with the following:

▪ the applicable health and safety regulations

▪ the applicable accident prevention regulations

▪ these Instructions for use

According to these regulations, the user is required to:

▪ to only use equipment that is operating correctly,

▪ adhere to the specified intended use

▪ to protect him or herself, the patient and third parties from hazards, and

▪ to prevent contamination from the product

3.2 Technical data

Drive pressure 3.2 - 5 bar (46 - 73 psi)

Air consumption 10 - 13 Nl/min

Water pressure 1.5 - 2.5 bar (22 - 36 psi)

Water quantity approx. 35 - 80 cm

3

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Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

3 Product description | 3.3 Scope of delivery

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3.3 Scope of delivery

The set consists of:
① 1 x PROPHYflex 3 – 2018 for Sirona connection
② 1 cannula
③ 1 cleaning drill
④ 1 powder container
⑤ 1 silicone rubber cover
⑥ 1 nozzle pins
⑦ 4 PROPHYflex powder (various flavours)
⑧ 1 PROPHYpearls®
⑨ 1 P-nozzle G
⑩ 1 x P-nozzle K (recess)

3.4 Transportation and storage conditions

NOTICE

Startup after refrigerated storage.
Malfunction.

▶ Prior to startup, very cold products must be heated up to a temperature of 20 °C

to 25 °C (68 °F to 77 °F).

Temperature: -20°C to +70°C (-4°F to +158°F)

Relative humidity: 5% RH to 95% RH absence of condensation

Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)

Protect from moisture

Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

4 Start up and shut down | 4.1 Mounting the Sirona coupling

4 Start up and shut down

WARNING

Hazard from non-sterile products.
Infection hazard for dentist and patient.

▶ Before first use and after each use, prepare and sterilise the medical device and

accessories appropriately.

WARNING

Dispose of the product in appropriate manner.
Infection hazard.

▶ Before disposal, reprocess and sterilise the product and accessories appropri-

ately.

NOTICE

Damage from soiled and moist cooling air.
Contaminated and moist cooling air can cause malfunctions.

▶ Make sure that the supply of cooling air is dry, clean, and uncontaminated accord-

ing to EN ISO 7494-2.

4.1 Mounting the Sirona coupling

WARNING

Detachment of the medical device during treatment.
A medical device that is not properly locked can detach from the Sirona coupling dur-

ing treatment.

▶ Before each treatment, check if the medical device is securely locked onto the

Sirona coupling.

▶ Screw the Sirona coupling onto the turbine hose.

The amount of water in the spray can be regulated by turning the spray ring at the
Sirona Regulatable coupling.

The water volume has a crucial effect on the cleaning efficiency and on dust develop­ment.

▪ Small water volume = little cleaning efficiency and a lot of dust.

▪ Large water volume = great cleaning efficiency and less dust.

Note

As the PROPHYflex 3 - 2018 SIRONA does not require any light or airspray, these
functions will need to be deleted.

4.2 Check the pressure

NOTICE

Contaminated or moist compressed air at the compressed air connection
Premature wear

▶ Ensure that the cooling air is dry, clean and uncontaminated in accordance with

EN ISO 7494-2.

A drive pressure of 3.2 bar (46 psi) is required for operating the PROPHYflex.

▶ Install the Sirona test manometer test star between the hose and coupling.

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Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

4 Start up and shut down | 4.3 Check O-rings

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▶ Attach the test manometer for Sirona Test star to the Sirona coupling and check

the following pressures:

ð - Drive air: 3.2 (46) to 5.0 (73) bar (psi)
ð - Water pressure: 1.5 (22) to 2.5 (36) bar (psi)

4.3 Check O-rings

NOTICE

Missing or damaged O-rings.
Malfunction and premature failure.

▶ Make sure that all O-rings are on the coupling and are undamaged.

Number of available O-rings: 4

Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

5 Operation | 5.1 Attaching the medical device

5 Operation

Note

At the beginning of each workday, the water-conducting systems should be rinsed
for at least 2 min. without the medical device being attached.

5.1 Attaching the medical device

WARNING

Detachment of the medical device during treatment.
A medical device that is not properly locked can detach from the Sirona coupling dur-

ing treatment.

▶ Before each treatment, check if the medical device is securely locked onto the

Sirona coupling.

▶ Precisely attach the medical device to the Sirona coupling and push is to the rear

until the coupling audibly locks in the medical device.

▶ Check if the medical device is securely seated on the coupling by pulling on it.

5.2 Remove the medical device

▶ Grasping the coupling, twist the medical device slightly and pull it off.

5.3 Filling the powder container

CAUTION

Open powder container.
Infection hazard from contaminated powder.

▶ If you do not need the powder container, close it with the rubber cover.
▶ Only use original KaVo powder.
▶ Comply with the safety data sheets for KaVo powders.
▶ Safety data sheets are available for inspection at www.kavo.com, "Safety data

sheets".

▶ Unscrew the powder container to the left against the direction of the arrow.

▶ Before filling the powder container, shake the powder in the refilling bag well.
▶ Screw on the powder container straight on to the right in the direction of the arrow.

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Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

5 Operation | 5.4 Inserting the cannula

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Adjusting the powder volume

The flow rate of the powder can be adjusted by changing the P-nozzle ①.

▪ P-nozzle G = larger powder volume

▪ P-nozzle K ① (recess) = smaller powder volume

5.4 Inserting the cannula

▶ Insert the cannula into the handpiece, and turn it clockwise in the direction of the

arrow up to the limit stop.

CAUTION

The marks must coincide or the cannula can become detached.
If the cannula comes off during treatment, it could substantially endanger the patient

and user.

▶ Pull on the cannula and check its firm seating before each treatment.
▶ Before each treatment, make sure that the cannula operates properly.

5.5 Removing the cannulas

▶ Turn the cannula all the way to the left in the direction of the arrow, and remove it.

Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

5 Operation | 5.6 Instructions for use for PROPHYflex Powder, PROPHYpearls®, PROPHYflex Perio Powder

5.6 Instructions for use for PROPHYflex Powder, PROPHYpearls®,
PROPHYflex Perio Powder

PPRROOPPHHYYfflleexx PPuullvveerr PPRROOPPHHYYppeeaarrllss

®®

PPRROOPPHHYYfflleexx PPeerriioo PPoowwddeerr

PROPHYflex powder PROPHYpearls

®

PROPHYflex Perio Powder

When:

▪ Conservative and aes-

thetic dentistry

▪ Cleaning of tooth sur-

faces

▪ Removal of stains and

plaque

▪ Orthodontics and pros-

thetics (pre- and after­treatment of adhesive
surfaces)

When:

▪ Conservative and aes-

thetic dentistry

▪ Cleaning of tooth sur-

faces

▪ Removal of stains and

plaque

▪ Orthodontics and pros-

thetics (pre- and after­treatment of adhesive
surfaces)

When:

▪ Subgingival treatment

▪ Removal of periodontal

biofilm

▪ For follow-up treatment

after the initial use in
periodontal therapy

▪ Preservation of dental

implants (including ti­tanium polish)

PROPHYflex powder PROPHYpearls

®

PROPHYflex Perio Powder

from red to white
working

from red to white
working

any
direction of work

water-soluble slightly water-soluble water-soluble

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Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

5 Operation | 5.6 Instructions for use for PROPHYflex Powder, PROPHYpearls®, PROPHYflex Perio Powder

16 / 26

5.6.1 PROPHYflex powder

CAUTION

Hazard from the use of PROPHYflex on the gingiva.
The gingiva may be damaged.

▶ Do not direct the powder jet toward the gingiva. Always work from pink to white.

The front part of the instrument can be rotated to reach the optimum working position
at all times.

The powder spray can be guided from the occlusal margin to the cervical margin of
the tooth without danger of injuring the dental alveolus and the ligaments. Discolouring
the biofilm of plaque, for example with erythrosine solution, is a very efficient, notice­able tool for limiting the blasting time to the required local amount as the red is re­moved. The jet should not directly contact the gingival margin, exposed tooth necks,
or the mucosa. The handpiece tip should be held approximately 3-5 mm from the sur­face of the tooth.

The inclination angle of the tip varies according to the position of the tooth and sur­face to be cleaned. For gentle treatment, the angle between the powder jet and the
axis of the tooth should be 60o to 90o. The jet should not directly impinge on the gin­gival margin, exposed tooth necks or the mucosa. Work from pink to white.

The abrasion can vary on devices in which the drive air can be adjusted with a foot
switch.

5.6.2 PROPHYpearls

®

CAUTION

Hazard from the use of PROPHYflex on the gingiva.
The gingiva may be damaged.

▶ Do not direct the powder jet toward the gingiva. Always work from pink to white.

The powder spray can be guided from the occlusal margin to the cervical margin of
the tooth without danger of injuring the dental alveolus and the ligaments. Discolouring
the biofilm of plaque, for example with erythrosine solution, is a very efficient, notice­able tool for limiting the blasting time to the required local amount as the red is re­moved. The jet should not directly contact the gingival margin, exposed tooth necks,
or the mucosa. The handpiece tip should be held approximately 3-5 mm from the sur­face of the tooth.

It is important to position the cannula at an angle of 10o to 60o with respect to the
treated tooth surface to ensure the rolling effect and thereby optimise the absorption
power of the spherical particles. At a flat angle, the Pearls roll off the tooth surface,
and the porous structure of the Pearls absorbs and efficiently removes the plaque over
a wide area.

The abrasion can vary on devices in which the drive air can be adjusted with a foot
switch.

Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

5 Operation | 5.6 Instructions for use for PROPHYflex Powder, PROPHYpearls®, PROPHYflex Perio Powder

2

1

① Sodium bicarbonate (PROPHYflex

Powder): working angle 60° to 90°

② Calcium carbonate (PROPHYpearls®):

working angle 10° to 60°

5.6.3 PROPHYflex Perio Powder

PROPHYflex Perio Powder (

Mat. no. 1.009.3732

)

5.6.4 Preparation

▶ Insert the reduced PROPHYflex P-nozzle K (recess) (

Mat. no. 0.573.0002

).

5.6.5 Treating the patient

▶ Guide the nozzle to the edge of the sulcus and into the gingival pocket and apply

the jet for max. 5 - 10 seconds for each side of a tooth (vestibular, mesial, oral,

distal).
▶ Do not direct the jet at just one spot, but move it in circular motions in order to

achieve a uniform cleaning effect.
▶ You can vary the angle of the jet nozzle with respect to the tooth between 30o and

60o. The smaller the angle, the deeper the jet will penetrate into the pocket. Use

PROPHYflex Perio powder in combination with the P-nozzle K only to a maximum

pocket depth of 5 mm.

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Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

6 Troubleshooting | 6.1 Cleaning a blocked cannula

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6 Troubleshooting

Preventive measures

After each treatment and before each sterilisation, unscrew the powder container in an
anti-clockwise direction and replace it with a clean powder container. Mount the PRO­PHYflex on the Sirona coupling and blow through the air and water channels. The
powder reservoir should be cleaned with a cloth once per week.

6.1 Cleaning a blocked cannula

▶ Remove the cannulas.

▶ Twist the nozzle needle from the front and then from the back into the cannula.
▶ The remove the nozzle needle, and blow out the cannula with compressed air.

6.2 Cleaning the main body

To prevent blockages, we recommend cleaning the main body once every week and
prior to each thermal disinfection or sterilization.

▶ Remove the cannulas.

▶ Unscrew the powder container anticlockwise.
▶ Unscrew the P-nozzle in an anti-clockwise direction and push through the aper-

ture with the nozzle pin.
▶ Clean the media tube with a cleaning drill or remove obstructions.
▶ Then blow through with compressed air.

Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

7 Reprocessing steps in accordance with ISO 17664 | 7.1 Preparation at the site of use

7 Reprocessing steps in accordance with ISO 17664

7.1 Preparation at the site of use

WARNING

Hazard from incorrectly reprocessed products.
Contaminated products are associated with an infection hazard.

▶ Take suitable personal protective measures.

▶ Immediately remove any residual blood.
▶ Reprocess the medical device as soon as possible after treatment.
▶ Unscrew the powder container from the handpiece by turning it in anticlockwise

direction.
▶ Empty the powder container before reprocessing the medical device.
▶ All residual powder has to be removed, especially from the cannula, the tubes and

the P-nozzle.
▶ The medical device must be dry when transported to reprocessing.
▶ Do not place in solutions or similar substance.

7.2 Cleaning

NOTICE

Never reprocess this medical device in an ultrasonic device.
Malfunction and material damage.

▶ Clean manually or in a washer disinfector only.

7.2.1 Manual cleaning of the exterior

Accessories required:

▪ Tap water 30 oC ± 5 oC (86 oF ± 10 oF)

▪ Brush, e.g. medium-hard toothbrush

▶ Brush off under flowing tap water.

7.2.2 Automated external cleaning

KaVo recommends washer disinfectors in compliance with EN ISO 15883-1 that are
operated with alkaline cleaning agents.
The validations were conducted with the VARIO-TD program, the cleaning agent
neodisher® MediClean and the neutralisation agent neodisher® Z.

▶ For program settings as well as cleansers and disinfectants to be used, please

refer to the Instructions for Use of the thermodisinfector.

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7 Reprocessing steps in accordance with ISO 17664 | 7.3 Disinfection

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7.2.3 Manual cleaning of the inside

Validated internal cleaning (removal of residual protein) can be accomplished with
KaVo CLEANspray and KaVo DRYspray.

▶ Cover the medical device with the KaVo CLEANpac bag, and place it on the cor-

responding servicing adapter. Press the spray button three times for 2 seconds

each time. Remove the medical device from the spray attachment and let the

cleanser act for one minute.
▶ Afterwards, rinse for 3-5 seconds with KaVo DRYspray.

See also:

2 KaVo CLEANspray / KaVo DRYspray Instructions for Use.

Note

KaVo CLEANspray and KaVo DRYspray for manual interior cleaning are only avail­able in the following countries:

Belgium, Denmark, Germany, Finland, France, United Kingdom, Italy, Luxembourg,
Netherlands, Norway, Austria, Poland, Portugal, Sweden, Switzerland and Spain.

In other countries interior cleaning can only be carried out with washer disinfectors
in accordance with EN ISO 15883-1.

7.2.4 Automated internal cleaning

KaVo recommends washer disinfectors in compliance with EN ISO 15883-1 that are
operated with alkaline cleaning agents.
The validations were conducted with the VARIO-TD program, the cleaning agent
neodisher® MediClean and the neutralisation agent neodisher® Z.

▶ For program settings as well as cleansers and disinfectants to be used, please

refer to the Instructions for Use of the thermodisinfector.
▶ In order to prevent damage to the medical device due to residual fluid, make sure

that the inside and outside of the device is dry after the end of the cycle. Remove

any residual liquids from the interior and exterior of the medical device using com-

pressed air.

The drying procedure is normally part of the cleaning program of the thermodisin­fector.

Note

Please comply with the instructions for use of the washer disinfector.

7.3 Disinfection

WARNING

Incomplete disinfection.
Infection hazard.

▶ Principally, KaVo recommends carrying out an final disinfection of the unpack-

aged item to guarantee the complete disinfection.

NOTICE

Never disinfect the handpiece with chlorine-containing products.
Malfunction and material damage.

▶ Only disinfect in a washer disinfector or manually.

Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

7 Reprocessing steps in accordance with ISO 17664 | 7.4 Care products and systems - Servicing

7.3.1 Manual disinfection of the the exterior

KaVo recommends the following products based on compatibility of the materials. The
microbiological efficacy must be ensured by the disinfectant manufacturer.

▪ Mikrozid AF made by Schülke & Mayr (liquid or cloths)

▪ FD 322 made by Dürr

▪ CaviCide made by Metrex

Consumables required:
Cloths for wiping the medical device.

▶ Spray the disinfectant on a cloth, then wipe down the medical device and allow

the disinfectant to act according to the instructions of the

disinfectant manufacturer.

▶ Follow the instructions for use of the disinfectant.

7.3.2 Manual disinfection of the interior

The efficacy of manual internal disinfection must be demonstrated by the manufac­turer of the disinfection agent. With KaVo products, use only disinfection agents that
have been released by KaVo with respect to the compatibility of materials (e.g. WL­cid / made by ALPRO).

▶ Follow the instructions for use of the disinfectant.

7.3.3 Mechanical disinfection of the exterior and interior

KaVo recommends washer disinfectors in compliance with EN ISO 15883-1 that are
operated with alkaline cleaning agents.
The validations were conducted with the VARIO-TD program, the cleaning agent
neodisher® MediClean and the neutralisation agent neodisher® Z.

▶ For program settings as well as cleansers and disinfectants to be used, please

refer to the Instructions for Use of the thermodisinfector.
▶ In order to prevent damage to the medical device due to residual fluid, make sure

that the inside and outside of the device is dry after the end of the cycle. Remove

any residual liquids from the interior and exterior of the medical device using com-

pressed air.

The drying procedure is normally part of the cleaning program of the thermodisin­fector.

Note

Please comply with the instructions for use of the washer disinfector.

7.4 Care products and systems - Servicing

NOTICE

Improper care.
Malfunction or property damage.

▶ Do not clean the PROPHYflex with oils or care spray.

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Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

7 Reprocessing steps in accordance with ISO 17664 | 7.5 Packaging

22 / 26

7.5 Packaging

Note

The sterilisation bag must be large enough for the instrument so that the bag is not
stretched.

The quality and use of the sterilisation packaging must comply with applicable
standards and be suitable for the sterilisation procedure!

▶ Weld each medical device individually in a sterilised item package!

7.6 Sterilisation

Sterilisation in a steam steriliser (autoclave) in accordance with EN
13060 / ISO 17665-1

NOTICE

Contact corrosion due to moisture.
Damage to product.

▶ Immediately remove the product from the steam steriliser after the sterilisation

cycle.

Note

Prior to attaching the powder container, all powder-conducting parts and air chan­nels must be absolutely dry. Screw together the powder container and handpiece
only in the cold state.

▶ Unscrew the powder container anticlockwise and drain and clean it before each

thermal disinfection or sterilisation.
▶ Do not screw the powder container back on before thermal disinfection or sterilisa-

tion.
▶ Likewise, clean off any powder residue on the PROPHYflex, especially the can-

nula, tubes and P-nozzle.

The KaVo medical device has a maximum temperature resistance up to 138 ℃
(280.4 °F).

Select a suitable procedure (depending on the available autoclave) from the following
sterilisation processes:

▪ Autoclave with triple pre-vacuum:

- at least 3 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F)

▪ Steriliser using the gravity method:

- at least 10 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F)

▶ Use according to the manufacturer's Instructions for Use.

7.7 Storage

▶ Reprocessed products should be stored protected from dust with minimum expos-

ure to germs in a dry, dark and cool place.
▶ Comply with the expiry date of the sterilised items.

Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

8 Tools

8 Tools

Available from specialised dealers

▶ Cannula 1

Mat. no. 0.573.0151

▶ Cannula 2

Mat. no. 0.573.0181

O-ring for cannulas

Mat. no. 0.200.6019

Powder container

Mat. no. 0.573.6152

Rubber closure

Mat. no. 1.000.2678

Container seal

Mat. no. 0.573.6072

Cleaning drill

Mat. no. 0.573.0321

Nozzle pin

Mat. no. 0.573.6052

P-nozzle G

Mat. no. 0.573.0412

P-nozzle K (recess)

Mat. no. 0.573.0002

PROPHYflex Powder orange,
Pack of 80 sticks

Mat. no. 1.007.0014

PROPHYflex Powder, berry,
Pack of 80 sticks

Mat. no. 1.007.0015

PROPHYflex Powder, cherry
Pack of 80 sticks

Mat. no. 1.007.0016

PROPHYflex Powder, mint
Pack of 80 sticks

Mat. no. 1.007.0017

PROPHYpearls® neutral,
Pack of 80 sticks

Mat. no. 1.010.1826

PROPHYpearls® mint,
Pack of 80 sticks

Mat. no. 1.010.1828

PROPHYpearls® peach,
Pack of 80 sticks

Mat. no. 1.010.1829

PROPHYpearls® orange,
Pack of 80 sticks

Mat. no. 1.010.1830

PROPHYpearls® black currant,
Pack of 80 sticks

Mat. no. 1.010.1831

PROPHYpearls® neutral,
4 bottles containing 250g each

Mat. no. 1.010.1798

PROPHYflex Perio Powder
4 bottles containing 100g each

Mat. no. 1.009.3732

23 / 26

Instructions for use PROPHYflex 3 - 2018 for Sirona connection - 1.006.9920, - 1.006.9927

9 Terms and conditions of warranty

24 / 26

9 Terms and conditions of warranty

The following warranty conditions apply to this KaVo medical device:

KaVo provides the end customer with a warranty of proper function and guarantees
zero defects in respect of material and processing for a period of 12 months from the
date of the invoice, subject to the following conditions:
In case of justified complaints, KaVo will honour its warranty with a free replacement
or repair. Other claims of any nature whatsoever, in particular with respect to com­pensation, are excluded. In the event of default, gross negligence or intent, this shall
only apply in the absence of mandatory legal regulations to the contrary.
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 connection instructions, calcination or corrosion, con­taminated air or water supplies or chemical or electrical factors deemed abnormal or
impermissible in accordance with KaVo's instructions for use or other manufacturer's
instructions. The warranty granted does not usually extend to lamps, light conductors
made of glass and glass fibres, glassware, rubber parts, and the colourfastness of
plastic parts.
All liability is excluded if defects or their consequences originate from manipulations or
changes to the product made by the customer or a third party that is not authorised by
KaVo.
Warranty claims will only be accepted if the product is submitted along with proof of
purchase in the form of a copy of the invoice or note of delivery. The dealer, purchase
date, type, and serial number must be clearly evident from this document.

1.007.1589 · bd · 20170410 - 07 · en