KaVo PROPHYflex 4 Perio Kit User manual

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

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 ................................................................................................................ 4
2 Safety.................................................................................................................................. 6
2.1 Infection hazard ............................................................................................................ 6
2.2 Air embolism and skin emphysema.................................................................................. 6
2.3 Technical condition......................................................................................................... 6
2.4 Accessories and combination with other equipment ........................................................... 7
2.5 Qualification of personnel................................................................................................ 7
2.6 Protective equipment ..................................................................................................... 7
3 Product Description ............................................................................................................ 8
3.1 Intended use................................................................................................................. 8
3.2 Transportation and storage conditions.............................................................................. 9
4 Startup and shut down.......................................................................................................10
4.1 Inserting the adaptor into the PROPHYflex........................................................................ 10
4.2 Inserting the PROPHYflex perio tip into the wrench............................................................ 10
4.3 Screwing the PROPHYflex perio tip onto the adaptor using the wrench................................. 11
4.4 Removing the PROPHYflex perio tip ................................................................................. 11
5 Operation............................................................................................................................ 13
6 Reprocessing steps in accordance with ISO 17664 ...........................................................15
6.1 Preparations at the site of use......................................................................................... 15
6.2 Non-fixing pre-cleaning of the PROPHYflex perio tip........................................................... 15
6.3 Manual Reprocessing...................................................................................................... 16
6.3.1 Manual external cleaning ..................................................................................... 16
6.3.2 Manual internal cleaning...................................................................................... 16
6.3.3 Manual external disinfection................................................................................. 16
6.3.4 Manual disinfection - internal ............................................................................... 17
6.3.5 Manual drying .................................................................................................... 17
6.4 Automated reprocessing................................................................................................. 18
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........ 19
6.4.3 Automated Drying .............................................................................................. 19
6.5 Visual inspection and functional check.............................................................................. 19
6.6 Care products and systems - Servicing............................................................................. 19
6.7 Packaging ..................................................................................................................... 19
6.8 Sterilisation................................................................................................................... 20
6.9 Storage ........................................................................................................................ 20
7 Tools ................................................................................................................................... 21
8 Terms and conditions of warranty .....................................................................................22
Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
Table of contents
3 / 24

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 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 in-
structions 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
oF)
Thermodisinfectable
Information on the packaging
Material number
Serial number
Legal Manufacturer
CE mark according to Medical Devices Directive EC 93/42

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
1 User instructions
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 in-
jury.
WARNING
In cases which – if not prevented – could lead to death or severe in-
jury.
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 / 24

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
2 Safety | 2.1 Infection hazard
6 / 24
2 Safety
The instructions for use are a component of the product and must be read care-
fully prior to use and be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.
2.1 Infection hazard
Patients, users or third parties could be infected by contaminated medical
devices.
▶Take suitable personal protective measures.
▶Follow the instructions for using the components.
▶Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
▶Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
▶If you deviate from this procedure, it is essential to make sure that the re-
processing is effective.
▶Reprocess the product and accessories appropriately before disposal.
2.2 Air embolism and skin emphysema
There is a danger that the insufflation of spray can cause air embolisms and
skin emphysema.
▶Avoid the insufflation of spray in open wounds.
The improper use of the product might lead to emphysema. Emphysema may
arise in extreme individual cases, especially in the presence of pathological gin-
gival pockets (> 3 mm), mucosal lesions, direct skin contact or contact with
soft tissue and/or improper handling.
▶The powder jet device must be used as briefly as possible.
▶The PROPHYflex perio tip may be re-used for up to10 times.
▶After the treatment, unscrew the empty powder container and rinse the
PROPHYFLEX perio tip with air and water for approx. 10 seconds.
▶For safety reasons, the torque wrench should be placed on the perio tip as
protection against injuries when the is PROPHYflex in the holder.
2.3 Technical condition
A damaged device or components could injure patients, users and third parties.
▶Only operate devices or components if they are undamaged on the outside.
▶Check that the device is working properly and is in satisfactory condition
before each use.
▶Have parts with sites of breakage or surface changes checked by the Ser-
vice.
Observe the following instructions in order to guarantee optimum functioning
and prevent material damage:
▶The device should be cleaned, serviced and stored in a dry location, accord-
ing to instructions, if it will not be used for a longer period.

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
2 Safety | 2.4 Accessories and combination with other equipment
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 understood the instructions for use.
▶Only employ the device if the user has the appropriate medical training.
▶Observe national and regional regulations.
2.6 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.
7 / 24

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
3 Product Description | 3.1 Intended use
8 / 24
3 Product Description
PROPHYflex 4 perio Kit - REF 1.011.9403
3
2
154 6
Index
①3x perio tip ②1x Adapter
③1x Wrench ④1x Nozzle pin
⑤2x Powder container ⑥2x Rubber cover subgingival
20g. Perio Powder
PROPHYflex perio tip Refill - REF 1.010.0287
3
2
1
Index
①10x perio tip ②1x Wrench
③1x Nozzle pin
The markings of the PROPHYflex perio tip are based on the WHO index.
3.1 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.

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
3 Product Description | 3.2 Transportation and storage conditions
Proper use:
According to these provisions, the medical device is only for the described use
in conformance with:
▪ the applicable health and safety regulations,
▪ the applicable accident prevention regulations
▪ and these instructions for use.
According to these regulations, the user is required to:
▪ only use properly operating equipment,
▪ to comply with the specified intended use.
▪ to protect himself, the patient and third parties from danger,
▪ to avoid contamination by the product.
3.2 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
9 / 24

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
4 Startup and shut down | 4.1 Inserting the adaptor into the PROPHYflex
10 / 24
4 Startup 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.
See also:
26 Reprocessing steps in accordance with ISO 17664, Page 15
WARNING
Dispose of the product in appropriate manner.
Infection hazard.
▶Before disposal, reprocess and sterilise the product and accessories appro-
priately.
▶Dispose of the perio tip like injection needles in a closed container.
See also:
26 Reprocessing steps in accordance with ISO 17664, Page 15
4.1 Inserting the adaptor into the PROPHYflex
CAUTION
Adapter falling off during the treatment.
The adapter falling off is a hazard for patient and user.
Visual inspection each time the adapter is inserted.
Before commencing the treatment, check that there is no gap between the ad-
apter and the gripping sleeve.
▶Insert the adapter in the gripping sleeve and use the wrench for the can-
nula (Mat. no. 3.004.6351) to tighten it in clockwise direction while hold-
ing on to the gripping sleeve.
4.2 Inserting the PROPHYflex perio tip into the wrench
▶Slide the PROPHYflex perio tip into the wrench until it locks into place.

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
4 Startup and shut down | 4.3 Screwing the PROPHYflex perio tip onto the adaptor using the wrench
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.
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 counter-clockwise
direction.
11 / 24

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
4 Startup and shut down | 4.4 Removing the PROPHYflex perio tip
12 / 24
▶Carefully pull the PROPHYflex perio tip out of the wrench.
Take the adapter off
▶Unscrew the adapter in counterclockwise direction using the wrench for the
cannula (Mat. no. 3.004.6351).

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 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.
▶The powder quantity can be controlled at three levels using the adjusting
ring on the PROPHYflex 4.
ðSelect the middle level for the treatment.
Add the powder
▶Shake the bottle before adding powder.
▶Add PROPHYflex Perio Powder to the marked level of the powder container.
Add the powder slowly to avoid the formation of dust.
▶Screw the container filled with the PROPHYflex Perio Powder onto the PRO-
PHYflex 4.
Settings on the powder jet unit
▶Aim the jet nozzle at a wet washbasin from a distance of approx. 20 cm.
▶Set the quantities 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.
13 / 24

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
5 Operation
14 / 24
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
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 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
6 Reprocessing steps in accordance with ISO 17664 | 6.1 Preparations at the site of use
6 Reprocessing steps in accordance with ISO 17664
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.
Note
The reprocessing procedures described in the following apply to the PROPHY-
flex 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 11
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 Non-fixing pre-cleaning of the PROPHYflex perio tip
Accessories required:
▪ Demineralised water 30 °C ± 2 °C (86 oF +/- 4 oF)
▪ Nozzle pin
▪ 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.
15 / 24

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
6 Reprocessing steps in accordance with ISO 17664 | 6.3 Manual Reprocessing
16 / 24
▶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.
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 4 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 4 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
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 medical device with chloride-containing products.
Malfunction and material damage.
▶Only disinfect in a washer disinfector or manually.

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
6 Reprocessing steps in accordance with ISO 17664 | 6.3 Manual Reprocessing
KaVo recommends the following products based on material compatibility. The
microbiological efficacy must be ensured by the disinfectant manufacturer.
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.
6.3.4 Manual disinfection - internal
Manual internal disinfection of the PROPHYflex 4 perio tip is not applicable. For
effective reprocessing, the inside of the device must be subjected to automated
cleaning in a cleaning and disinfection unit in accordance with ISO 15883-1.
6.3.5 Manual drying
Use KaVo DRYspray for subsequent drying of the air, water and gear unit ducts.
▶Cover the medical device with the KaVo CLEANpac bag, and place it on the
corresponding care adapter.
▶Hold the can vertically.
▶Press the spray key for at least 3 seconds.
See also:
2KaVo 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, Latvia,
Lithuania, Luxembourg, Netherlands, Norway, Austria, Poland, Portugal,
Sweden, Switzerland, Spain and the Czech Republic.
In other countries interior cleaning can only be carried out with washer disin-
fectors in accordance with EN ISO 15883-1.
17 / 24

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
6 Reprocessing steps in accordance with ISO 17664 | 6.4 Automated reprocessing
18 / 24
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 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.
6.4.1 Preparation for automated internal and external
cleaning as well as internal and external disinfection
Note
For reprocessing, attach the PROPHYflex perio tip ③ with adapter ② to the
cleaning adapter PROPHYflex 4 long (Mat. no. 3.004.6640) ①.
▶Slide the PROPHYflex perio tip into the wrench until it locks into place.
▶Screw the PROPHYflex perio tip onto the adapter in clockwise direction hold-
ing the wrench with 2 fingers.
▶Pull the wrench off.
▶Attach the PROPHYflex perio tip to the cleaning adapter PROPHYflex 4 long
(Mat. no. 3.004.6640).
3
2
1
①PROPHYflex perio tip ②Adaptor
③Cleaning adapter
PROPHYflex 4 long
▶Place the cleaning adapter PROPHYflex 4 long (Mat. no. 3.004.6640) on
the receptacle for INTRA connectors.

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
6 Reprocessing steps in accordance with ISO 17664 | 6.5 Visual inspection and functional check
6.4.2 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 10.
The validation was conducted with a Miele washer disinfector using the
"VARIO-TD" programme, the "neodisher® mediClean" 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.
6.4.3 Automated Drying
The drying procedure is normally part of the cleaning program of the thermod-
isinfector.
Note
Please observe the instructions for use of the thermodisinfector.
▶In order to prevent impairment of the KaVo medical device, make sure that
the inside and outside of the device is dry after the end of the cycle.
▶Remove any residual liquids with KaVo DRYspray.
See also:
26.3.5 Manual drying, Page 17
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.
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.
19 / 24

Instructions for use PROPHYflex 4 Perio Kit - 1.011.9403 Refill PROPHYflex perio tip - 1.010.0287
6 Reprocessing steps in accordance with ISO 17664 | 6.8 Sterilisation
20 / 24
6.8 Sterilisation
Sterilisation in a steam steriliser (autoclave) according
to 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.
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 fol-
lowing 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)
▶Use according to the manufacturer's Instructions for Use.
6.9 Storage
Reprocessed products must be stored appropriately such that they are protec-
ted from germs (as far as possible) and dust, in a dry, dark, cool room.
Note
Comply with the expiry date of the sterilised items.