KaVo PROPHYflex 1.009.3731 User manual

Instructions for use
PROPHYflex Perio Kit – 1.009.3731
Refill PROPHYflex perio tip – 1.010.0287

Distributed by:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
Phone [phone]
Fax [phone]
Manufacturer:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
www.kavo.com

Table of contents
1 User instructions ................................................................................................................ 4
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 Protective equipment ..................................................................................................... 8
3 Product description ............................................................................................................ 9
3.1 Purpose – Intended use.................................................................................................. 9
3.2 Transportation and storage conditions ............................................................................. 10
3.2.1 Currently applicable packaging law....................................................................... 10
4 Startup and shut down....................................................................................................... 11
4.1 Inserting the adaptor into the PROPHYflex........................................................................ 11
4.2 Inserting the PROPHYflex perio tip into the wrench............................................................ 11
4.3 Screwing the PROPHYflex perio tip onto the adaptor using the wrench ................................ 11
4.4 Removing the PROPHYflex perio tip ................................................................................. 12
5 Operation............................................................................................................................ 13
6 Preparation methods according to ISO 17664...................................................................15
6.1 Preparations at the site of use......................................................................................... 15
6.2 Pre-cleaning.................................................................................................................. 15
6.3 Manual reprocessing ...................................................................................................... 16
6.3.1 Manual external cleaning .................................................................................... 16
6.3.2 Manual internal cleaning ..................................................................................... 16
6.3.3 Manual external disinfection ................................................................................ 16
6.3.4 Manual disinfection - internal............................................................................... 17
6.3.5 Manual drying.................................................................................................... 17
6.4 Automated reprocessing................................................................................................. 17
6.4.1 Preparation for automated internal and external cleaning as well as internal and
external disinfection ........................................................................................... 18
6.4.2 Automated internal and external cleaning and internal and external disinfection ....... 18
6.4.3 Automated Drying.............................................................................................. 18
6.5 Visual inspection and functional check.............................................................................. 18
6.6 Care products and systems - Servicing ............................................................................ 19
6.7 Packaging ..................................................................................................................... 19
6.8 Sterilisation................................................................................................................... 19
6.9 Storage ........................................................................................................................ 19
7 Tools ................................................................................................................................... 21
8 Terms and conditions of warranty .....................................................................................22
Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
Table of contents
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Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
1 User instructions
4 / 24
1 User instructions
Dear User
Congratulations on purchasing this KaVo quality product. By following the notes
below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
KaVo, PROPHYflex and PROPHYpearls are either registered trademarks or
trademarks of KaVo Dental GmbH.
All other trademarks are property of their respective owners.
KaVo Original Factory Repair
In the event of a repair, please ship your product to the KaVo Original Factory
Repair using www.kavobox.com.
KaVo Technical Service
If you have any questions or complaints, please contact the KaVo
Technical Service:
[phone]
[e-mail]
Target group
The instructions for use are intended for medical professionals, in particular
dentists and dental practice personnel.
The section on startup is also intended for the service staff.
General marks and symbols
See Chapter on User Instructions/Hazard Levels
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.
Medical device, labelling of medical devices
Can be steam-sterilised at 134 oC -1 oC / +4 oC (273 oF -1.6 oF / +7.4
oF)

Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
1 User instructions
Thermodisinfectable
Information on the packaging
Material number
Serial number
Manufacturer
Note: Please note accompanying documents
Follow the electronic instructions for use
HIBC Code
CE mark for medical devices
Medical device, labelling of medical devices
Transportation and storage conditions
(Temperature range)
Transportation and storage conditions
(Air pressure)
Transportation and storage conditions
(Humidity)
Protect from moisture (Keep dry)
Protect from impact
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 in-
jury.
WARNING
In cases which – if not prevented – can lead to death or severe injury.
5 / 24

Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
1 User instructions
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CAUTION
In cases which – if not prevented – can lead to minor or moderate in-
jury.
NOTICE
In cases which – if not prevented – can lead to material damage.

Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
2 Safety | 2.1 Infection hazard
2 Safety
Note
All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.
The instructions for use are a component of the product and must be read care-
fully prior to use and be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.
2.1 Infection hazard
Patients, users or third parties could be infected by contaminated medical
devices.
▶Take suitable personal protective measures.
▶Follow the instructions for use of 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.
▶If there is any 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 gin-
gival pockets (> 3 mm), mucosal lesions, direct skin contact or contact with
soft tissue and/or improper handling.
▶The powder jet device must be used as briefly as possible.
▶The PROPHYflex perio tip may be re-used for up to10 times.
▶After the treatment, unscrew the empty powder container and rinse the
PROPHYFLEX perio tip with air and water for approx. 10 seconds.
▶For safety reasons, the torque wrench should be placed on the perio tip as
protection against injuries when the is PROPHYflex in the holder.
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Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
2 Safety | 2.3 Technical condition
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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 reprocessed and stored in a dry location, according to
instructions, if it is 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 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 comprehends the instructions for use.
▶Make sure that the user has read and comprehends the national and re-
gional regulations.
▶The device may be used only if the user has completed the appropriate
medical training.
2.6 Protective equipment
PROPHYflex Powder and other powders can be aspirated or get into the eyes 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.

Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
3 Product description | 3.1 Purpose – Intended use
3 Product description
PROPHYflex Perio Kit – 1.009.3731
3
2
1
① 1 x adaptor, ② 3 x perio tip, ③ 1 x wrench, ④ 1 x nozzle needle
In addition, the PROPHYflex Perio Kit (Mat. no. 1.009.3731) contains:
▪ 1 x nozzle for regulating powder supply - small diameter
▪ 2x powder container
▪ 2x rubber cover cap subgingival (pink)
▪ 1x PROPHYflex Perio powder 20 g
PROPHYflex perio tip Refill – 1.010.0287
3
2
1
10 x perio tip, ② 1 x wrench, ③ 1 x nozzle pin
8,5 mm
5,5 mm
3,5 mm
The markings of the PROPHYflex perio tip are based on the WHO index.
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 PROPHYflex perio tip is designed for use in combination with PROPHY-
flex Perio Powder for the removal of sub- and supragingival plaque.
Proper use:
According to these regulations, this product 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
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Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
3 Product description | 3.2 Transportation and storage conditions
10 / 24
According to these regulations, the user is required:
▪ 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
▪ to prevent contamination from the product
3.2 Transportation and storage conditions
NOTICE
Startup after refrigerated storage.
Malfunction.
▶Prior to startup, strongly refrigerated products must be allowed to warm up
to a temperature of 20 °C to 25 °C (68 °F to 77 °F).
Storage temperature: -10 °C to +25 °C (+14 °F to +77 °F)
Transport temperature: -10 °C to +40 °C (+14 °F to +104 °F)
Relative humidity: 10% RH to 85% RH absence of condensation
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture (Keep dry)
3.2.1 Currently applicable packaging law
Dispose of and recycle the packaging appropriately in accordance with current
packaging law, employing waste management / recycling companies. Comply
with the comprehensive return system. KaVo has had its packaging licensed for
this purpose. Please comply with the regional public waste-disposal system.

Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
4 Startup and shut down | 4.1 Inserting the adaptor into the PROPHYflex
4 Startup and shut down
WARNING
Hazard from contaminated products.
Infection hazard for care provider and patient.
▶Prior to initial commissioning and after each use, reprocess the product and
accessories.
WARNING
Dispose of the product in the appropriate manner.
Prior to disposal, the product and accessories must be appropriately prepared
or sterilised according to need.
Dispose the perio tip like injection needles in a closed container.
See also:
26 Reprocessing methods according to ISO 17664, Page 15
4.1 Inserting the adaptor into the PROPHYflex
CAUTION
The markings must coincide; otherwise the cannula can detach.
If the adaptor detaches during treatment, it can give rise to a substantially
hazard for the patient and user.
▶Pull on the adaptor before each treatment and check if it is seated firmly.
▶Before each treatment, make sure that the adaptor works properly.
▶Insert the adaptor into the bayonet closure and lock it by turning it clock-
wise. Locking is successful of the two markings on the handpiece and the
adaptor are situated directly across from each other.
4.2 Inserting the PROPHYflex perio tip into the wrench
▶Slide the PROPHYflex perio tip into the wrench until it locks into place.
4.3 Screwing the PROPHYflex perio tip onto the adaptor
using the wrench
CAUTION
Hazard from detachment of the perio tip during the treatment.
This can lead to a significant hazard for user and patient.
▶Pull on the perio tip before each treatment and check if it is seated firmly.
▶Before each treatment, make sure that the perio tip works properly.
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Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
4 Startup and shut down | 4.4 Removing the PROPHYflex perio tip
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Note
In order to screw it on, hold the wrench with 2 fingers in the round grasping
area (not at the cover for the perio tip).
▶Screw the PROPHYflex perio tip onto the adaptor in clockwise direction hold-
ing the wrench with 2 fingers.
▶Pull the wrench off and check if the perio tip is seated firmly by pulling on it.
4.4 Removing the PROPHYflex perio tip
▶Slide the wrench onto the PROPHYflex perio tip.
▶Unscrew the PROPHYflex perio tip using the wrench in anticlockwise direc-
tion.
▶Carefully pull the PROPHYflex perio tip out of the wrench.
Take the adaptor off
▶Open the lock of the bayonet closure through an anticlockwise rotation.
▶Pull the adaptor out of the bayonet closure.

Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
5 Operation
5 Operation
Preparation
CAUTION
Risk of increased development of emphysema.
If the pressure is too high during the treatment, there is an increased risk of
emphysema developing.
▶Do not select the highest level for the treatment.
▶Insert the reduced PROPHYflex nozzle K (see image on the left, with level
puncture) (Mat. no. 0.573.0002).
Add the powder
▶Remove all residues of other cleaning powders from the device and con-
tainer.
▶Shake the bottle before adding powder.
▶Add PROPHYflex Perio Powder to the powder container up to the marked
level. Add the powder slowly to avoid the formation of dust.
▶Screw the container filled with the PROPHYflex Perio Powder onto the PRO-
PHYflex.
Settings on the powder jet unit
▶Aim the jet nozzle at a wet washbasin from a distance of approx. 20 cm.
▶Set the quantities of water and air/powder for treatment as described in the
Instructions for Use of the unit. Never use the powder jet device without
water since this would render the mixture of air/powder more difficult to as-
pirate.
▶Direct the jet into a washbasin until a homogeneous powder/water mixture
is produced.
Getting the patient ready
▶Apply some Vaseline® ointment to the patient's lips. This prevents the lips
from becoming dry and cracking.
▶Hook the small saliva ejector in the corner of the patient's mouth such that
the saliva is extracted from under the tongue. Use a large suction cannula
for aspiration of the water/powder mixture bouncing off the tooth.
Treating the patient
CAUTION
Hazard from overly frequent use or dropping of the handpiece.
The PROPHYflex perio tip can fracture or be contaminated.
▶Re-use the PROPHYflex perio tip for up to 10 times.
Indication
▪ Pockets with a probing depth of up to 5 mm
▪ Use 1-3 weeks after initial treatment with sonic, ultrasonic or hand-held in-
struments
▪ Root tip with at least 3 mm bony periodontium comprises
▪ Record X-ray image for clarification
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Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
5 Operation
14 / 24
Contraindication
▪ Apical focus
▪ Root caries
Treatment procedure:
1. Introduce the perio tip to the floor of the pocket, then pull the perio tip out
by 1-2 mm.
2. Start-up the PROPHYflex with the foot control.
3. Using slight swinging motions, pull the perio tip out of the pocket and deac-
tivate the foot control.
4. Spray the treated sites with anti-inflammatory agent twice daily for 1 to 4
weeks.
Note
The PROPHYflex perio tip must not be used in combination with powder for
supragingival plaque.
Note
Please advise your patients that the intake of foods (tea, coffee or food
items) in the first 2-3 hours after the treatment may lead to discoloration of
the teeth.
Note
The abrasion can be varied on devices in which the drive air can be adjusted
with a foot switch.

Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
6 Preparation methods according to ISO 17664 | 6.1 Preparations at the site of use
6 Preparation methods according to ISO 17664
Note
The reprocessing procedures described in the following apply to the
PROPHYflex perio tip, adaptor and wrench.
6.1 Preparations at the site of use
WARNING
Hazard from contaminated products.
Contaminated products are associated with an infection hazard.
▶Take suitable personal protective measures.
Note
Do not place the perio tip in the drill bit bath since the fine capillaries will not
be able to be rinsed under running water any longer and strong corrosion oc-
curs.
▶Use the wrench to remove the PROPHYflex perio tip from the adaptor.
See also:
24.4 Removing the PROPHYflex perio tip, Page 12
Note
Hardened or damaged adaptor O-rings need to be replaced.
▶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.
6.2 Pre-cleaning
Accessories required:
▪ Demineralised water 30 ℃ +/-2 ℃ (86 oF +/-4 oF)
▪ Nozzle needle
▪ Brush, e.g. medium-hard toothbrush
▪ Disposable syringe
▶Brush the PROPHYflex perio tip with a medium-hard toothbrush under de-
mineralised water.
▶Check the patency of the PROPHYflex perio tip and if necessary clean it with
the nozzle pin (Mat. no. 0.410.0911).
▶Rinse the PROPHYflex perio tip with at least 20 ml demineralised water us-
ing a disposable syringe.
▶If the PROPHYflex perio tip cannot be determined to be patent after the
manual rinsing procedure or once 10 reprocessing cycles have been com-
pleted, the medical device must be replaced.
15 / 24

Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
6 Preparation methods according to ISO 17664 | 6.3 Manual reprocessing
16 / 24
6.3 Manual reprocessing
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
NOTICE
Never reprocess this medical device in an ultrasonic device.
Malfunction and material damage.
▶Clean it in a washer disinfector only.
6.3.1 Manual external cleaning
Manual external cleaning of the PROPHYflex perio tip is not applicable. For ef-
fective reprocessing after non-fixating pre-cleaning, the inside of the device
must be subjected to automated cleaning in a cleaning and disinfection unit in
accordance with ISO 15883-1.
6.3.2 Manual internal cleaning
Manual internal cleaning of the PROPHYflex perio tip is not applicable. For ef-
fective reprocessing after non-fixating pre-cleaning, the inside of the device
must be subjected to automated cleaning in a cleaning and disinfection unit in
accordance with ISO 15883-1.
6.3.3 Manual external disinfection
The PROPHYflex perio tip is not designed for manual external disinfection. 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.
▶Manual external disinfection is permissible only as an occupational safety
measure (personal protection measure).
NOTICE
Never disinfect the medical device with chloride-containing products.
Malfunction and material damage.
▶Only disinfect in the washer disinfector.
KaVo recommends the following products based on compatibility of the materi-
als. The microbiological efficacy must be ensured by the disinfectant manufac-
turer and proven by an expert opinion.
Approved disinfectants:
▪ Mikrozid AF made by Schülke & Mayr (liquid or cloths)

Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
6 Preparation methods according to ISO 17664 | 6.4 Automated reprocessing
▪ FD 322 made by Dürr
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.
6.3.4 Manual disinfection - internal
Manual internal disinfection of the PROPHYflex perio tip is not applicable. For ef-
fective reprocessing, the inside of the device must be subjected to automated
cleaning in a cleaning and disinfection unit in accordance with ISO 15883-1.
6.3.5 Manual drying
Manual drying of the PROPHYflex perio tip is not applicable. For effective repro-
cessing, the inside of the device must be subjected to automated cleaning in a
cleaning and disinfection unit in accordance with ISO 15883-1.
6.4 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.
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
NOTICE
Never disinfect the medical device with chloride-containing products.
Malfunction and material damage.
▶Only disinfect in the washer disinfector.
NOTICE
Never reprocess this medical device in an ultrasonic device.
Malfunction and material damage.
▶Clean it in a washer disinfector only.
17 / 24

Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
6 Preparation methods according to ISO 17664 | 6.5 Visual inspection and functional check
18 / 24
6.4.1 Preparation for automated internal and external
cleaning as well as internal and external disinfection
Note
Place the PROPHYflex perio tip on the servicing adaptor (Mat. no.
3.000.4383) for reprocessing.
▶Slide the PROPHYflex perio tip into the wrench until it locks into place.
▶Screw the PROPHYflex perio tip onto the adaptor in clockwise direction hold-
ing the wrench with 2 fingers.
▶Pull the wrench off.
▶Attach the adaptor, with the PROPHYflex perio tip screwed into it, to the
servicing adaptor (Mat. no. 3.000.4383).
① servicing adaptor, ② adaptor, ③ PROPHYflex perio tip
▶Plug the servicing adaptor (Mat. no. 3.000.4383) onto the Miele adaptor.
6.4.2 Automated internal and external cleaning and
internal and external disinfection
KaVo recommends thermodisinfectors in accordance with EN ISO 15883-1,
which are operated with alkaline cleaning agents.
The validation was performed in a Miele washer disinfector using the
"VARIO-TD" programme and the "neodisher MediClean forte" cleaner made by
Dr. Weigert.
In addition, KaVo recommends the use of a neutraliser and a rinsing agent.
▶For programme settings and the adaptation options to be used, please refer
to the Instructions for Use of the washer disinfector.
6.4.3 Automated Drying
The drying procedure is normally part of the cleaning programme of the washer
disinfector.
Note
Please comply with the instructions for use of the washer disinfector.
▶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.
6.5 Visual inspection and functional check
Note
Plug the adaptor with the PROPHYflex perio tip onto the PROPHYflex with an
empty powder container, and check it.

Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
6 Preparation methods according to ISO 17664 | 6.6 Care products and systems - Servicing
6.6 Care products and systems - Servicing
NOTICE
Improper care.
Malfunction or property damage.
▶Do not service the PROPHYflex perio tip and adapter with oils or care spray.
6.7 Packaging
Note
The sterilisation bag must be large enough to accommodate the perio tip
without stretching the bag.
The quality and use of the sterilisation packaging must comply with applic-
able standards and be suitable for the sterilisation procedure!
▶The medical device must be packed before sterilisation.
6.8 Sterilisation
Sterilisation in a steam steriliser (autoclave) in
accordance with EN 13060 / EN 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 while the parts are cold.
The KaVo medical device has a maximum temperature resistance up to 138 ℃
(280.4 °F).
Sterilisation parameters:
Select a suitable process from the following sterilisation processes (depending
on the available steriliser):
▪ 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.
6.9 Storage
Prepared products must be stored appropriately in a dry, dark, cool room such
that they are protected from germs (as far as possible) and dust.
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Instructions for use PROPHYflex Perio Kit – 1.009.3731 Refill PROPHYflex perio tip – 1.010.0287
6 Preparation methods according to ISO 17664 | 6.9 Storage
20 / 24
Note
Comply with the expiry date of the sterilised items.