Instructions for use
SonicFill Handpiece
Manufactured for:
Kerr Corporation
1717 W. Collins Ave
Orange CA 92867
U.S.A.
1 User instructions
Dear user,
Congratulations on purchasing this Kerr quality product. Following the instructions below will allow
you to work smoothly, economically and safely.
User instructions 1
Symbols
Refer to the Chapter on Safety/Warning symbols
Important information for users and service technicians
Thermodisinfectable
User instructions 2
Can be sterilized with steam at 134 °C -1 °C / +1 °C (273 °F -1.6 °F / +1.6 °F)
Action request
Target group
This document is intended for dentists and their assistants. The section on starting up is also
intended for service technicians.
User instructions 3
2 Safety
2.1.1 Description of safety instructions: Warning symbol
Warning symbol
Safety 4
2.1.2 Description of safety instructions: Structure
DANGER
The introduction describes the type and source of the hazard.
This section describes the potential consequences of non-observance.
▶ The optional step includes necessary measures for hazard prevention.
Safety 5
2.1.3 Description of safety instructions: Description of danger levels
The safety instructions cited herein with the three levels of danger will help avert property damage
and injury.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property or mild to moderate injuries.
Safety 6
WARNING
WARNING
indicates a hazardous situation that can cause death or serious injury.
DANGER
DANGER
indicates a hazardous situation that can directly cause death or serious injury.
Safety 7
2.2 Safety instructions
WARNING
Hazard to the care provider and patient.
Stop working in case of damage, irregular noise during operation, excessive vibration, unusual
build-up of heat or if the SonicFill Unidose tip cannot be firmly held.
▶ Before extended periods of non-use, the instrument must be cleaned, serviced and stored
in dry condition according to the instructions.
Safety 8
CAUTION
Premature wear and malfunctioning from improper storage during long periods of nonuse.
Reduced product life.
▶ The medical device should be cleaned, serviced and stored in a dry location, according to
instructions, before long periods of nonuse.
Safety 9
CAUTION
Injury or damage due to wear.
If you notice uneven operating noises, excessive or unexpectedly low vibrations or the SonicFill
Unidose tip coming undone.
▶ Stop working and contact service support.
Safety 10
CAUTION
Swallowing or aspiration of the SonicFill Unidose tip by the patient.
▶ Before each treatment involving the SonicFill handpiece, insert a rubber dam for safety
reasons.
The following persons are authorized to repair and service Kerr products:
▪ Technicians specially trained by Kerr
To ensure proper function, the medical device must be set up according to the methods described
in the Kerr instructions for use, and the care products and methods described therein must be
Safety 11
used. Kerr recommends specifying a service interval at the dental office for a licensed shop to
clean, service and check the functioning of the medical device. This service interval should take
into account the frequency of use.
Service may only be provided by repair shops that have undergone training by Kerr and that use
original Kerr replacement parts.
Safety 12
3 Product description
SonicFill handpiece
SonicFill handpiece is a dental handpiece in accordance with ISO 15606. The handpiece is de‐
signed for sound-activated dispensation of a composite material that has a greatly reduced vis‐
cosity during the dispensing process and subsequently quickly transforms into the more viscous
state of a restorative composite.
Product description 13
3.1 Purpose – Proper use
Purpose:
The SonicFill handpiece is a dental delivery system intended to be used to dispense SonicFill, a
dental restorative resin, directly into dental cavities.
Product description 14
This medical device is
▪ intended for dental treatment only. Any other type of use or alteration to the product is im‐
permissible and can be hazardous.
The SonicFill handpiece must be used exclusively in combination with the SonicFill Unidose
tip for filling dental cavities with composite materials.
▪ A medical device according to relevant national statutory regulations.
Product description 15
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.
Product description 16
According to these regulations, the user is required to:
▪ only use properly operating equipment,
▪ use the equipment for the proper purpose,
▪ to protect himself, the patient and third parties from danger,
▪ to avoid contamination from the product.
3.2 Technical Specifications
Drive air 3 – 4.2 bar (43 – 61 psi)
Air consumption 20 – 40 NL/min
Product description 17
Frequency 5 – 6 kHz
Ejection force 0 to 170 N
Note that the values above apply to the pressure within the handpiece and not to the dental unit
itself. If the dental unit is set between 2.1 - 3.5 bar (30 - 50 psi) (which is normally the case when
a turbine is used), no adjustment should be necessary. If adjustment is required, please see the
directions for proper measurement and calibration of the handpiece pressure on page 25 of this
manual.
The SonicFill handpiece can be mounted on all MULTIflex couplings.
Product description 18
3.3 Transportation and storage conditions
CAUTION
It is hazardous to start up the medical device after it has been stored refrigerated.
This can cause the medical device to malfunction.
▶ Prior to start-up, very cold products must be heated to a temperature of 20 °C to 25 °C
(68 °F to 77 °F).
Product description 19
Temperature: -20°C to +70°C (-4°F to +158°F)
Relative humidity: 5% RH to 95% RH absence of condensation
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture
Product description 20
4 First use
Mediated by a MULTIflex coupling, the SonicFill handpiece can be connected to any turbine hose
of a treatment unit.
WARNING
Hazard from non-sterile products.
Infection hazard for care provider and patient.
▶ Before first use and after each use, sterilise the medical device.
First use 21
4.1 Connection to devices
WARNING
Damage from soiled and moist drive air.
Contaminated and moist drive air can cause malfunctions and lead to premature bearing wear.
▶ Always make sure that the supply of drive air is dry, clean and uncontaminated according
to ISO 7494-2.
First use 22
4.2 Installing the MULTIflex coupling
▶ Screw the MULTIflex LUX/MULTIflex LED coupling onto the turbine hose and tighten with
the wrench.
First use 23
4.3 Check the O-rings
CAUTION
Missing or damaged O-rings.
Malfunctions and premature failure.
▶ Make sure that all O-rings are on the coupling and undamaged.
Number of available O-rings: 5
First use 24
4.4 Check the pressure using a test manometer
A minimum drive pressure of 3 bar (43 psi)
measured at the handpiece
is required to operate the
SonicFill handpiece.
3.5 bar (50 psi) is ideal
. Between 3.5 - 4.2 bar (51 - 62 psi) the drive air will
be automatically reduced within the SonicFill handpiece. The air consumption is approximately 20
- 40 NI/min. Insert the test manometer between the MULTIflex coupling and the SonicFill hand‐
piece. Adjust regulating ring on level 5.
Pressure displayed:
▪ Drive air T.R. = 3 - 4.2 bar (43 - 61 psi)
▪ Return air R.L. < 0.4 bar (6 psi)
▪ No water or spray air are needed, though.
First use 25
5 Operation
5.1 Attaching the SonicFill handpiece
▶ Place the SonicFill handpiece exactly on the MULTIflex (LUX) / MULTIflex LED coupling
and push it to the rear until it audibly locks.
Operation 26
▶ If your coupling system is equipped with a light, please wait for at least 5 seconds before
you remove the SonicFill handpiece to prevent damage to the light source.
CAUTION
Ensure that the SonicFill handpiece is firmly seated on the coupling.
The SonicFill handpiece can be a hazard for patient and user if it inadvertently comes undone
on the coupling during the treatment.
▶ Before each treatment, pull on the SonicFill handpiece to check if it is securely seated on
the coupling.
Operation 27
5.2 Detaching the SonicFill handpiece
▶ Hold the MULTIflex (LUX) / MULTIflex LED coupling tight, and pull the SonicFill handpiece
forward while twisting slightly.
Operation 28
5.3 Inserting the SonicFill Unidose Tips
DANGER
The SonicFill handpiece must be used in combination with SonicFill Unidose tips exclusively.
Noncompliance may lead to product damage. Ensure that the SonicFill Unidose Tips are firmly
attached to the SonicFill handpiece. Before each treatment, pull on the SonicFill Unidose tip to
see if it is securely attached to the instrument. If the SonicFill Unidose tip is difficult to screw-on,
this is due to a defect and the SonicFill Unidose tip must not be used since it may become de‐
tached during use. Check if the SonicFill Unidose tips are firmly connected by briefly starting-up
the SonicFill handpiece outside the mouth.
Operation 29
Operation 30
▶ Push the SonicFill Unidose tips by hand into the corresponding opening of the SonicFill
handpiece using moderate pressure and turn the handpiece in a clockwise direction, screw‐
ing it into the SonicFill tip.
5.4 Removing the SonicFill Unidose Tips
▶ Unscrew the SonicFill Unidose tips by hand from the SonicFill handpiece through a counter‐
clockwise rotation.
Operation 31
5.5 Power setting
Use the regulating ring of the SonicFill handpiece to adjust the dispensed quantity.
Level 1 = low, level 5 = high
Dispensing with a variable foot control positions:
Variable foot controls allow the dispensing rate to be controlled with different foot pedals. In this
case, it is recommended to set the regulating ring on the handpiece to 5.
Operation 32
6 Preparation methods according to ISO 17664
6.1 Preparations at the site of use
WARNING
Hazard from nonsterile products.
There is a risk of infection from contaminated medical devices.
▶ Take suitable personal protective measures.
▶ Remove all residual cement, composite or blood without delay.
Preparation methods according to ISO 17664 33
▶ The medical device must be dry when transporting it to the site of reprocessing.
(do not place in any type of solution).
▶ The medical device should be reprocessed as quickly as possible after the treatment.
6.2 Preparations before cleaning
▶ Remove the SonicFill Unidose tips by hand from the SonicFill handpiece.
Preparation methods according to ISO 17664 34
6.3 Cleaning
CAUTION
Malfunctions from cleaning in the ultrasonic unit.
Defects in the product.
▶ Only clean manually or in a thermodisinfector.
Preparation methods according to ISO 17664 35
6.3.1 Cleaning: Manual cleaning - external
▶ Accessories required:
- Tap water 30 °C ± 5 °C (86 °F ± 10 °F)
- Brush, e.g. medium-hard toothbrush
Brush under running tap water using, e.g., a medium-hardness toothbrush.
Preparation methods according to ISO 17664 36
6.3.2 Cleaning: Automated external cleaning
Kerr recommends thermodisinfectors in accordance with EN ISO 15883 that are operated with al‐
kaline cleaning agents at a pH of max. 10 (e.g. Miele G 7781 / G 7881 – validation was performed
with the ""VARIO-TD" programme, "neodisher® mediclean" cleaning agent, "neodisher® Z" neutral‐
isation agent, and "neodisher® mielclear" rinsing agent and extends only to the compatibility of
materials with respect to Kerr products).
▶ For program settings as well as cleansers and disinfectants to be used, please refer to the
Instructions for Use of the thermodisinfector (complying with max. pH value of 10).
Preparation methods according to ISO 17664 37
▶ In order to prevent negative effects on the medical device made by Kerr, make sure that the
interior and the exterior of the medical device are dry, and then lubricate immediately with
care agents from the Kerr care system.
6.4 Disinfection
CAUTION
Malfunctioning from using a disinfectant bath or disinfectant containing chlorine.
Defects in the product.
▶ Only disinfect in a thermodisinfector or manually.
Preparation methods according to ISO 17664 38
6.4.1 Disinfection: Manual disinfection - external
Kerr recommends the following products based on material compatibility.
▪ CaviCide made by Metrex
Preparation methods according to ISO 17664 39
Consumables required:
Cloths for wiping off the medical device.
Spray the disinfectant on a cloth, then thoroughly wipe down the medical device and leave the
disinfectant to soak in according to the instructions from the disinfectant manufacturer.
Note
Follow the instructions for use of the disinfectant.
Preparation methods according to ISO 17664 40
6.4.2 Disinfection: Machine disinfection - external and internal
Kerr recommends thermodisinfectors in accordance with EN ISO 15883 that are operated with al‐
kaline cleaning agents at a pH of max. 10 (e.g. Miele G 7781 / G 7881 – validation was performed
with the ""VARIO-TD" programme, "neodisher® mediclean" cleaning agent, "neodisher® Z" neutral‐
isation agent, and "neodisher® mielclear" rinsing agent and extends only to the compatibility of
materials with respect to Kerr products).
▶ For program settings as well as cleansers and disinfectants to be used, please refer to the
Instructions for Use of the thermodisinfector (complying with max. pH value of 10).
Preparation methods according to ISO 17664 41
▶ In order to prevent negative effects on the medical device made by Kerr, make sure that the
interior and the exterior of the medical device are dry, and then lubricate immediately with
care agents from the Kerr care system.
6.5 Drying
Manual Drying
▶ Blow off the outside and inside with compressed air until water drops are no longer visible.
Automatic Drying
The drying procedure is normally part of the disinfection program of the thermodisinfector.
Preparation methods according to ISO 17664 42
Note
Please follow the instructions for use of the thermodisinfector (compressed air quality - see the
Warning under "Start-up").
Preparation methods according to ISO 17664 43
6.6 Care products and systems - Servicing
CAUTION
Premature wear and malfunctions from improper servicing and care.
Reduced product life.
▶ Perform proper care regularly!
Preparation methods according to ISO 17664 44
Note
Kerr guarantees the proper function of Kerr products only if the care products listed by Kerr un‐
der accessories are used, as these have been tested for proper use on our products.
6.6.1 Care products and systems - Servicing: Servicing involving SonicFill Hand‐
piece Lubrication Spray
Kerr recommends servicing the product after each use after each automatic cleaning and before
each sterilization.
Preparation methods according to ISO 17664 45
Note
If the oil leakage is bothersome, once weekly servicing is sufficient.
▶ Remove the SonicFill Unidose Tips.
▶ Cover the product with the cellulose bag.
Preparation methods according to ISO 17664 46
▶ Place the product on the SonicFill MULTIflex coupling, and press the spray button for one
second.
6.7 Packaging
Note
The sterilization bag must be large enough for the instrument so that the bag is not stretched.
Seal each medical device individually in a sterilised item package!
Preparation methods according to ISO 17664 47
6.8 Sterilization
Sterilization in a steam sterilizer (autoclave) in accordance with EN 13060/ISO
17665-1
CAUTION
Premature wear and malfunctions from improper servicing and care.
Reduced product life.
▶ Service the medical device before each sterilization cycle.
Preparation methods according to ISO 17664 48
CAUTION
Contact corrosion due to moisture.
Damage to product.
▶ Immediately remove the product from the steam steriliser after the sterilisation cycle!
Note
Remove the SonicFill Unidose tip before sterilization. The SonicFill Unidose tips are non-steriliz‐
able.
Preparation methods according to ISO 17664 49
The medical device has a maximum temperature resistance up to 138 ℃ (280.4 °F).
Preparation methods according to ISO 17664 50
(Depending on the available autoclave,) select a suitable procedure from the following sterilisation
processes:
▪ Autoclave with pre-vacuum:
– at least 3 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F)
Drying time: 20 min.
▪ • Autoclave 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)
Drying time for using one of the gravity methods is 30 minutes.
▶ Use according to the manufacturer's Instructions for Use.
Preparation methods according to ISO 17664 51
6.9 Storage
Prepared products must be stored, 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.
Preparation methods according to ISO 17664 52
7 Tools
Obtainable from an authorized Kerr distributor.
Material summary Mat. no.
SonicFill Handpiece Lubrication Spray 35207
SonicFill MULTIflex coupling 35134
Tools 53
8 Terms and conditions of warranty
Kerr’s technical advice, whether verbal or in writing, is designed to assist dentists in using Kerr’s
product. The dentist assumes all risk and liability for damages arising out of the improper use of
Kerr’s product. In the event of a defect in material or workmanship, Kerr’s liability is limited, at
Kerr’s option, to replacement of the defective product or part thereof, or reimbursement of the ac‐
tual cost of the defective product. In order to take advantage of this limited warranty, the defective
product must be returned to Kerr. In no event shall Kerr be liable for any indirect, incidental, or
consequential damages. EXCEPT AS EXPRESSLY PROVIDED ABOVE, THERE ARE NO WAR‐
RANTIES, BY KERR, EXPRESS OR IMPLIED, INCLUDING WARRANTIES WITH RESPECT TO
DESCRIPTION, QUALITY, OR FITNESS FOR A PARTICULAR PURPOSE.
Terms and conditions of warranty 54
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