KaVo PROPHYflex 4 Instructions For Use Manual

Instructions for use

PROPHYflex 4

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.................................................................................................................................. 7

2.1 Infection hazard ............................................................................................................ 7

2.2 Air embolism and skin emphysema.................................................................................. 7

2.3 Technical condition......................................................................................................... 8

2.4 Accessories and combination with other equipment........................................................... 8

2.5 Qualification of personnel................................................................................................ 8

2.6 Application.................................................................................................................... 8

2.7 Service and repair.......................................................................................................... 9

2.8 Protective equipment ..................................................................................................... 9

3 Product description ............................................................................................................10

3.1 Purpose – Intended use ................................................................................................. 10

3.2 Technical data ............................................................................................................... 11

3.3 Scope of delivery ........................................................................................................... 12

3.4 Transportation and storage conditions.............................................................................. 13

4 Start up and shut down ......................................................................................................14

4.1 Installing the MULTIflex coupling..................................................................................... 14

4.2 Check the O-rings (MULTIflex) ........................................................................................ 14

5 Operation............................................................................................................................ 15

5.1 Attaching the medical device........................................................................................... 15

5.2 Remove the medical device ............................................................................................ 15

5.3 Filling the powder container ............................................................................................ 15

5.4 Mounting the gripping sleeve .......................................................................................... 17

5.5 Screwing-in the cannula ................................................................................................. 17

5.6 Unscrewing the cannula.................................................................................................. 17

5.7 Instructions for use for PROPHYflex Powder, PROPHYpearls®, PROPHYflex Perio Powder ....... 18

6 Troubleshooting .................................................................................................................19

6.1 Cleaning a blocked cannula............................................................................................. 19

6.2 Cleaning a clogged main body......................................................................................... 20

7 Reprocessing steps in accordance with ISO 17664 ........................................................... 22

7.1 Preparation at the site of use .......................................................................................... 22

7.2 Disassembly.................................................................................................................. 22

7.3 Manual Reprocessing...................................................................................................... 22

7.3.1 Manual external cleaning..................................................................................... 22

7.3.2 Manual internal cleaning...................................................................................... 23

7.3.3 Manual external disinfection................................................................................. 23

7.3.4 Manual internal disinfection.................................................................................. 23

7.3.5 Manual drying .................................................................................................... 23

7.4 Automated reprocessing................................................................................................. 24

7.4.1 Overview of the reprocessing options.................................................................... 25

7.4.2 Pre-cleaning....................................................................................................... 26

7.4.3 Preparation for automated internal and external cleaning as well as internal and

external disinfection............................................................................................ 26

7.4.4 Automated internal and external cleaning and internal and external disinfection........ 27

Instructions for use PROPHYflex 4

Table of contents

3 / 34

7.4.5 Automated drying............................................................................................... 27

7.5 Care products and systems - Servicing............................................................................. 27

7.6 Packaging ..................................................................................................................... 27

7.7 Sterilisation................................................................................................................... 28

7.8 Storage ........................................................................................................................ 28

8 Auxiliary equipment ...........................................................................................................29

9 Terms and conditions of warranty .....................................................................................31

Instructions for use PROPHYflex 4

Table of contents

4 / 34

Instructions for use PROPHYflex 4

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

KaVo Technical Service

If you have any questions or complaints, please contact the KaVo
Technical Service:
[phone]
[e-mail]

KaVo Repair Service

For repairs, please contact your local dealer or the KaVo
Repair Service directly:
[phone]
[e-mail]

Target group

This document is intended for dentists and their assistants. The startup section
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

Action request

CE mark (European Community). A product bearing this mark meets
the requirements of the applicable EC directive.

Can be steam-sterilised at 134 oC -1 oC / +4 oC (273 oF -1.6 oF / +7.4

o

F)

Thermodisinfectable

Information on the packaging

Material number

Serial number

Legal Manufacturer

CE mark according to Medical Devices Directive EC 93/42

5 / 34

Instructions for use PROPHYflex 4

1 User instructions

6 / 34

Please note the electronic instructions for use

Note: observe accompanying documents

EAC conformity mark (Eurasian Conformity)

GOST R certification

Transportation and storage conditions
(Temperature range)

Transportation and storage conditions
(Air pressure)

Transportation 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 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.

Instructions for use PROPHYflex 4

2 Safety | 2.1 Infection hazard

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 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.
▶ In the case of injury to soft tissue, do not continue treatment in the oral

cavity with compressed air-driven instruments.

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 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.
▶ 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.

7 / 34

Instructions for use PROPHYflex 4

2 Safety | 2.3 Technical condition

8 / 34

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.

▶ If you notice any of the following defects on the product or accessories, stop

working and have the service personnel carry out repair work.

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.

2.4 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.
▶ Only use consumables that have been approved for combination with the

product by the manufacturer.

▶ Do not make any modifications to the device 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 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.

2.6 Application

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.

Instructions for use PROPHYflex 4

2 Safety | 2.7 Service and repair

2.7 Service and repair

Repairs and servicing 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

training

Observe all the following items during servicing work:

▶ Have the service and testing tasks carried out according to the Medical

Product Operator Ordinance.

▶ KaVo recommends specifying in-house service intervals where the medical

device is brought to a professional shop for cleaning, servicing and a func­tion check. Defined the service interval depending on the frequency of use.

Cleansers and disinfectants that have not been approved can damage the
plastic housing leading to hairline cracks and other damage which can ulti­mately lead to hazards.

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 treat-

ment.

▶ KaVo recommends the use of dust extraction equipment and mouth protec-

tion during the treatment with PROPHYflex.

9 / 34

Instructions for use PROPHYflex 4

3 Product description | 3.1 Purpose – Intended use

10 / 34

3 Product description

PROPHYflex 4 Wave (Mat. no. 3.002.8000)
PROPHYflex 4 Lime (Mat. no. 3.002.8200)
PROPHYflex 4 Flamingo (Mat. no. 3.002.8800)
PROPHYflex 4 S Wave (Mat. no. 3.004.5900)
PROPHYflex 4 S Lime (Mat. no. 3.004.5930)
PROPHYflex 4 S Flamingo (Mat. no. 3.004.5950)

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, orthodontics, cleaning prior to fissure sealing, prosthetics, con­servative and aesthetic dentistry. Please refer also to the Instructions for
Use.

▪ A medical device according to relevant national statutory regulations.

Proper use:

According to these provisions, 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,

Instructions for use PROPHYflex 4

3 Product description | 3.2 Technical data

▪ 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 1.0 - 2.5 bar (15 - 36 psi)

Spray water flow approx. 35 - 80 cm

3

Spray air pressure 1.0 - 2.5 bar (15 - 36 psi)

Attachable to all MULTIflex (LUX) / MULTIflex LED couplings.

11 / 34

Instructions for use PROPHYflex 4

3 Product description | 3.3 Scope of delivery

12 / 34

3.3 Scope of delivery

1

2

3

4

5

6

7

8

9

The set consists of:

No./
Item no.

Description Mat.No.

1 x ① PROPHYflex 4 with:

Long gripping sleeve
Cannula
Powder container

3.003.0520

3.003.1138

3.002.8136

1 x ② Short gripping sleeve

Cannula

3.003.2607

3.003.1138

1 x ③ Powder container ⑤

Rubber cover supra ④

3.002.8136

3.004.4708

1 x ⑥ Cleaning drill 0.573.0321

1 x ⑦ Nozzle pin 0.573.6052

1 x ⑧ Wrench for cannula 3.004.6351

1 x ⑨ O-rings for powder container and coupling in-

terface to the gripping sleeve

can be ordered individually

See also:

2 8 Tools and consumables, Page 29

Instructions for use PROPHYflex 4

3 Product description | 3.4 Transportation and storage conditions

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 85% RH absence of condensation

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

Protect from moisture

13 / 34

Instructions for use PROPHYflex 4

4 Start up and shut down | 4.1 Installing the MULTIflex coupling

14 / 34

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 appro-

priately.

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

according to EN ISO 7494-2.

4.1 Installing the MULTIflex coupling

WARNING

Detachment of the medical device during treatment.

A medical device that is not properly locked can release from the MULTIflex
coupling during treatment.

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

MULTIflex coupling.

▶ Screw the MULTIflex coupling onto the turbine hose.

▶ Open the water supply all the way using the spray ring on the MULTIflex

coupling.

4.2 Check the O-rings (MULTIflex)

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: 5

Instructions for use PROPHYflex 4

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 minutes (without transmission handpieces being at­tached) and if there is a risk of contamination from reflux or back suction, the
system may also need to be rinsed for 20 to 30 seconds after each patient.

5.1 Attaching the medical device

WARNING

Detachment of the medical device during treatment.

A medical device that is not properly locked can release from the MULTIflex
coupling during treatment.

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

MULTIflex coupling.

▶ Mount the medical device accurately on the MULTIflex (LUX) / MULTIflex

LED coupling and push it backward 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.

▶ Only use original KaVo powder.
▶ Reprocess and refill the powder container before each patient.
▶ Comply with the safety data sheets for KaVo powders.
▶ Safety data sheets are available for inspection at www.kavo.com, "Safety

data sheets".

15 / 34

Instructions for use PROPHYflex 4

5 Operation | 5.3 Filling the powder container

16 / 34

▶ Unscrew the powder container anticlockwise.

▶ Before filling the powder container, shake the powder in the refilling bag

well.

▶ Fill the powder container up to the marking.

▶ Keep the powder container closed by the rubber cover until the powder is

used on the patient.

▶ Remove the rubber cover before use.
▶ To screw-on the powder container and to tighten it keep the container up-

right and turn to the right.

Adjusting the powder volume

The powder quantity can be controlled at 3 levels using the adjusting ring:

▪ The highest level is suitable for supragingival treatment and offers full

cleaning power

▪ The medium level is suitable for sub- and supragingival treatment and en-

ables gentle cleaning at a reduced powder quantity

▪ The lowest level helps rinsing the powder off the tooth and blowing the

powder from the system after the treatment; it is nearly free of powder

Instructions for use PROPHYflex 4

5 Operation | 5.4 Mounting the gripping sleeve

5.4 Mounting the gripping sleeve

The gripping sleeve is available in two different lengths.

▪ Long gripping sleeve: 3.003.0520
▪ Short gripping sleeve: 3.003.2607

▶ Mount the ergonomically fitting gripping sleeve on the instrument without

tilting it.

5.5 Screwing-in the cannula

CAUTION

Cannula falls off during the treatment.

Detachment of the cannula is a hazard for patient and user.
Visual inspection after each time the cannula is inserted with the wrench for

the cannula.
Before commencing the treatment, check that there is no gap between the

cannula and the gripping sleeve.

▶ Insert the cannula in the gripping sleeve with the wrench for the cannula

and screw it in clockwise while holding on to the gripping sleeve.

5.6 Unscrewing the cannula

▶ Unscrew the cannula in counterclockwise direction using the wrench for the

cannula.

17 / 34

Instructions for use PROPHYflex 4

5 Operation | 5.7 Instructions for use for PROPHYflex Powder, PROPHYpearls®, PROPHYflex Perio Powder

18 / 34

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

PROPHYflex powder PROPHYpearls

®

PROPHYflex Perio
Powder

When:

▪ Conservative and aes-

thetic dentistry

▪ Cleaning of tooth sur-

faces

▪ Removal of stains and

plaque

▪ Orthodontics and

prosthetics (pre- and
after-treatment of ad­hesive surfaces)

When:

▪ Conservative and aes-

thetic dentistry

▪ Cleaning of tooth sur-

faces

▪ Removal of stains and

plaque

▪ Orthodontics and

prosthetics (pre- and
after-treatment of ad­hesive surfaces)

When:

▪ Subgingival treatment
▪ Removal of period-

ontal biofilm

▪ For follow-up treat-

ment 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

NOTICE

Do not run the instrument with RONDOflex powder.

Defects on the PROPHYflex.

See also:

2 Instructions for use PROPHYlex powder, PROPHYpearls®,

PROPHYflex Perio Powder

Instructions for use PROPHYflex 4

6 Troubleshooting | 6.1 Cleaning a blocked cannula

6 Troubleshooting

Preventive measures

▶ After each treatment and before each sterilisation, unscrew the powder

container in an anticlockwise direction and replace it with a clean powder
container.

▶ Mount the PROPHYflex on the MULTIflex coupling and blow through the air

and water channels.

▶ Switch the water off and blow through the air and water channels again.

6.1 Cleaning a blocked cannula

▶ Unscrew the cannula in anticlockwise direction using the wrench.

▶ Slide the nozzle needle into the cannula from the front while rotating it.

▶ Then slide the nozzle needle into the cannula from the back while rotating

it.

▶ Then remove the nozzle needle, and blow out the cannula with compressed

air.

19 / 34

Instructions for use PROPHYflex 4

6 Troubleshooting | 6.2 Cleaning a clogged main body

20 / 34

6.2 Cleaning a clogged main body

▶ Pulling off the grip sleeve with cannula.

▶ Unscrew the powder container anticlockwise.

▶ Push the nozzle needle through the aperture of the nozzle.

▶ Use the cleaning drill to clean or remove obstructions from the media tube.

▶ Then blow through with compressed air.

If the clogging persists:

▶ Use the wrench for cannula to unscrew the nozzle by placing the lateral re-

cess of the wrench on the nozzle and unscrewing the nozzle.

Instructions for use PROPHYflex 4

6 Troubleshooting | 6.2 Cleaning a clogged main body

▶ Use the cleaning drill to clean or remove obstructions from the media tube

from the front and the back.

▶ Tighten the nozzle with the wrench again.

▶ Blow compressed air through.

21 / 34

Instructions for use PROPHYflex 4

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

22 / 34

7 Reprocessing steps in accordance with ISO 17664

7.1 Preparation at the site of use

WARNING

Hazard from contaminated products.

Contaminated products are associated with an infection hazard.

▶ Take suitable personal protective measures.

▶ Reprocess the medical device as soon as possible after treatment.
▶ The medical device must be dry when transported to reprocessing.
▶ To minimise the risk of infection during reprocessing, always wear protect-

ive gloves.

▶ Remove all residual cement, composite or blood immediately.
▶ Do not place in solutions or similar substance.

7.2 Disassembly

WARNING

Incomplete reprocessing.

Infection hazard.

▶ To ensure complete reprocessing of all parts, the medical device needs to

be disassembled before reprocessing.

▶ Unscrew the powder container.
▶ Pull the gripping sleeve off.
▶ Remove the cannula from the gripping sleeve.

7.3 Manual Reprocessing

NOTICE

Never reprocess this medical device in an ultrasonic device.

Malfunction and material damage.

▶ Clean manually or in a washer disinfector only.

7.3.1 Manual external cleaning

Accessories required:

▪ Tap water 30 oC ± 2 oC (86 oF ± 4 oF)
▪ Brush, e.g. medium-hard toothbrush

▶ Brush off under flowing tap water.

Instructions for use PROPHYflex 4

7 Reprocessing steps in accordance with ISO 17664 | 7.3 Manual Reprocessing

7.3.2 Manual internal cleaning

Manual internal cleaning of the PROPHYflex 4 is not applicable. For effective re­processing, the inside of the device must be subjected to automated cleaning in
a cleaning and disinfection unit in accordance with ISO 15883-1.

7.3.3 Manual external disinfection

WARNING

Incomplete disinfection.

Infection hazard.

▶ Only use disinfection procedures that are verified to be bactericidal, fungi-

cidal and virucidal.

▶ If the disinfectants used do not meet these requirements, the process must

be concluded by disinfection of the unit(s) without packaging using a steam
steriliser.

NOTICE

Never disinfect the handpiece with chloride-containing products.

Malfunction and material damage.

▶ Only disinfect in a washer disinfector or manually.

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

Approved disinfectants:

▪ 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.

7.3.4 Manual internal disinfection

Manual internal disinfection of the PROPHYflex 4 is not applicable. For effective
reprocessing, the inside of the device must be subjected to automated cleaning
in a cleaning and disinfection unit in accordance with ISO 15883-1.

7.3.5 Manual drying

Manual drying of the PROPHYflex 4 is not applicable. For effective reprocessing,
the inside of the device must be subjected to automated cleaning in a cleaning
and disinfection unit in accordance with ISO 15883-1.

23 / 34

Instructions for use PROPHYflex 4

7 Reprocessing steps in accordance with ISO 17664 | 7.4 Automated reprocessing

24 / 34

7.4 Automated reprocessing

WARNING

Incomplete disinfection.

Infection hazard.

▶ Only use disinfection procedures that are verified to be bactericidal, fungi-

cidal and virucidal.

▶ If the disinfectants used do not meet these requirements, the process must

be concluded by disinfection of the unit(s) without packaging using a steam
steriliser.

NOTICE

Never disinfect the handpiece with chloride-containing products.

Malfunction and material 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 disinfector only.

Instructions for use PROPHYflex 4

7 Reprocessing steps in accordance with ISO 17664 | 7.4 Automated reprocessing

7.4.1 Overview of the reprocessing options

Pre-clean­ing

Automated
external
cleaning

Automated
internal
cleaning

Automated
internal
and ex­ternal dis­infection

Sterilisa­tion

Main body

Gripping
sleeve

Cannula /
Adapter +
Perio Tip

Gripping
sleeve and
cannula /
Adapter +
Perio Tip

Powder
container

not
applicable

Cover for
powder con­tainer

not
applicable

Wrench for
cannulas

not
applicable

possible

Note

Adapters are needed for automated cleaning.

Order adapter separately.

See also:

2 8 Tools and consumables, Page 29

25 / 34

Instructions for use PROPHYflex 4

7 Reprocessing steps in accordance with ISO 17664 | 7.4 Automated reprocessing

26 / 34

7.4.2 Pre-cleaning

Accessories required:

▪ Tap water 30 oC ± 2 oC (86 oF ± 4 oF)
▪ Brush, e.g. medium-hard toothbrush

▶ Disassemble the instrument completely.
▶ Brush off all individual parts under running tap water.

7.4.3 Preparation for automated internal and external
cleaning as well as internal and external disinfection

Miele Series G 7881/7891

Main body required material:

Cleaning cover PROPHYflex 4
(3.004.6658)
Reprocessing with Miele AUF Ad­apter

Gripping sleeve required material:

Cleaning in Miele sieve basket

Cannula / Adapter + Perio Tip required material:

Cleaning adapter PROPHYflex 4
long (3.004.6640)
Reprocessing with Miele AUF Ad­apter

Gripping sleeve and cannula /
Adapter + Perio Tip

Reprocessing with Miele AUF Ad­apter

Powder container required material:

Reprocessing in Miele sieve bas­ket

Instructions for use PROPHYflex 4

7 Reprocessing steps in accordance with ISO 17664 | 7.5 Care products and systems - Servicing

Miele Series G 7881/7891

Cover for powder container required material:

Reprocessing in Miele sieve bas­ket

Wrench for cannulas required material:

Reprocessing in Miele sieve bas­ket

7.4.4 Automated internal and external cleaning and
internal and external disinfection

KaVo recommends washer disinfectors according to EN ISO 15883-1, which
are operated using alkaline cleaning agents having a maximum pH value of 11.
The validation was conducted with a Miele washer disinfector using the
"VARIO-TD" programme, the "neodisher® mediclean forte" cleaning agent, the
neodisher® Z" neutralisation agent and the "neodisher® mielclear" rinsing
agent.

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

please refer to the Instructions for Use of the washer disinfector.

7.4.5 Automated drying

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

Note

Please observe the instructions for use of the thermodisinfector.

▶ In order to prevent impairment of the KaVo medical device, make sure that

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

7.5 Care products and systems - Servicing

NOTICE

Improper care.

Malfunction or property damage.

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

7.6 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!

▶ The medical device must be packed before sterilisation.

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Instructions for use PROPHYflex 4

7 Reprocessing steps in accordance with ISO 17664 | 7.7 Sterilisation

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7.7 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 steril-

isation 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.

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:

▪ Steriliser 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) or
alternatively

- at least 60 minutes at 121 °C -1 °C / +4 °C (250 °F -1.6 °F / +7.4 °F)

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

7.8 Storage

Reprocessed products must be stored appropriately such that they are protec­ted from germs (as far as possible) and dust, in a dry, dark, cool room.

Note

Comply with the expiry date of the sterilised items.

Instructions for use PROPHYflex 4

8 Auxiliary equipment

8 Auxiliary equipment

Available from dental suppliers.

Cannula Mat. no. 3.003.1138

Powder container Mat. no. 3.002.8136

Rubber cover supragingival Mat. no. 3.004.4708

Rubber cover subgingival Mat. no. 3.004.4709

Cleaning drill Mat. no. 0.573.0321

Nozzle pin Mat. no. 0.573.6052

Nozzle Mat. no. 3.004.2324

Long gripping sleeve Mat. no. 3.003.0520

Short gripping sleeve Mat. no. 3.003.2607

Cleaning adapter
PROPHYflex 4 long

Mat. no. 3.004.6640

Cleaning cover
PROPHYflex 4

Mat. no. 3.004.6658

Cleaning adapter
PROPHYflex 4

Mat. no. 3.004.8509

Cleaning adapter
PROPHYflex 4 S

Mat. no. 3.004.8523

PROPHYflex 4 Perio Kit Mat. no. 1.011.9403

O-ring for powder container Mat. no. 3.003.0608

O ring for coupling interface to
gripping sleeve, rear

Mat. no. 1.004.2776

O ring for coupling interface to
gripping sleeve, front, and can­nula

Mat. no. 0.200.6084

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Instructions for use PROPHYflex 4

8 Auxiliary equipment

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PROPHYflex Powder orange,
Pack of 80 sticks
PROPHYflex Powder, berry,
Pack of 80 sticks
PROPHYflex Powder, cherry
Pack of 80 sticks
PROPHYflex Powder, mint
Pack of 80 sticks

Mat. no. 1.007.0014

Mat. no. 1.007.0015

Mat. no. 1.007.0016

Mat. no. 1.007.0017

PROPHYpearls® neutral,
Pack of 80 sticks

Mat. no. 1.010.1826

PROPHYpearls® mint,
Pack of 80 sticks
PROPHYpearls® peach,
Pack of 80 sticks
PROPHYpearls® orange,
Pack of 80 sticks
PROPHYpearls® black currant,
Pack of 80 sticks

Mat. no. 1.010.1828

Mat. no. 1.010.1829

Mat. no. 1.010.1830

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

Instructions for use PROPHYflex 4

9 Terms and conditions of warranty | 7.8 Storage

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, non­compliance 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.

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1.013.1827 · sö · 20180212 - 02 · en