KaVo Kerr SonicFill Handpiece User manual

Instructions for use
SonicFill Handpiece

Manufactured on behalf of:
Kerr Corporation
1717 West Collins Avenue
Orange, CA 92867 USA
1-800-KERR-123
www.kerrdental.com

Table of contents
us-english ......................................................................................................................... 3
français............................................................................................................................... 25

Table of contents
1 User instructions ................................................................................................................ 6
2 Safety.................................................................................................................................. 8
2.1 Infection hazard ............................................................................................................ 8
2.2 Technical condition......................................................................................................... 8
2.3 Application.................................................................................................................... 8
2.4 Accessories and combination with other equipment........................................................... 9
2.5 Qualification of personnel................................................................................................ 9
2.6 Service and repair.......................................................................................................... 9
3 Description of the product..................................................................................................10
3.1 Intended use................................................................................................................. 10
3.2 Technical Specifications.................................................................................................. 11
3.3 Transportation and storage conditions.............................................................................. 11
4 Startup and shut-down.......................................................................................................12
4.1 Installing the MULTIflex coupling..................................................................................... 12
4.2 Checking the O-rings ..................................................................................................... 12
4.3 Checking the pressures .................................................................................................. 13
5 Operation............................................................................................................................14
5.1 Attaching the SonicFill handpiece..................................................................................... 14
5.2 Pulling off the SonicFill handpiece .................................................................................... 14
5.3 Inserting the SonicFill Unidose Tips.................................................................................. 14
5.4 Removing the SonicFill Unidose Tips ................................................................................ 15
5.5 Power setting ................................................................................................................ 15
6 Processing steps in accordance with ISO 17664 ...............................................................16
6.1 Preparations at the site of use ........................................................................................ 16
6.2 Preparations before cleaning .......................................................................................... 16
6.3 Manual processing ......................................................................................................... 16
6.3.1 Manual external cleaning .................................................................................... 16
6.3.2 Manual external disinfection ................................................................................ 16
6.3.3 Manual drying .................................................................................................... 17
6.4 Automated processing.................................................................................................... 17
6.4.1 Automated internal and external cleaning and internal and external disinfection........ 18
6.4.2 Automated drying............................................................................................... 18
6.5 Care products and systems - Servicing ............................................................................ 18
6.5.1 Servicing with a lubrication spray and a MULTIflex coupling..................................... 18
6.6 Packaging ..................................................................................................................... 19
6.7 Sterilization................................................................................................................... 19
6.8 Storage ........................................................................................................................ 19
7 Tools and consumables ......................................................................................................21
8 Terms and conditions of warranty .....................................................................................22
Table of contents
5 / 46

1 User instructions
6 / 46
1 User instructions
Dear User,
Congratulations on purchasing this KaVo Kerr quality product. By following the
instructions below you will be able to work smoothly, economically and safely.
Kerr Customer Care
For repairs, please contact your local dealer or Kerr Customer Care directly:
Toll-free: 1-800-KERR-123
Homepage: www.kerrdental.com
Target group
This document is intended for dentists and dental assistants. The chapter on
commissioning 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
Sterilization parameters
▪ Sterilizer with triple pre-vacuum:
- at least 3 minutes at 135°C (275 °F)
- Drying time: 16 min.
▪ Sterilizer with single pre-vacuum:
- at least 4 minutes at 132°C (270 °F)
- Drying time: 20 min.
▪ Sterilizer using the gravity method:
- at least 30 minutes at 121°C (250 °F)
- Drying time: 15 min.
Suitable for disinfection in a washer disinfector
Information on the package labeling
Catalogue number
Serial number
Legal Manufacturer
CE mark according to Medical Devices Directive EC 93/42
Please note the electronic instructions for use

1 User instructions
Caution: Consult instructions for use
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 range)
Protect from moisture (Keep dry)
Fragile, handle with care
HIBC Code
Hazard levels
The warning and safety notes in this document must be observed to prevent
personal injury and property 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.
CAUTION
In cases which – if not prevented – can lead to moderate or mild in-
jury.
NOTICE
In cases which – if not prevented – can lead to property damage.
7 / 46

2 Safety | 2.1 Infection hazard
8 / 46
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 can be infected by contaminated medical de-
vices.
▶Take suitable personal protective measures.
▶Follow the instructions for use of the components.
▶Before initial startup and after each use, process the product and acces-
sories appropriately.
▶Carry out the processing as described in the instructions for use. The proce-
dure has been validated by the manufacturer.
▶If you deviate from this procedure, it is essential to make sure that the pro-
cessing is effective.
▶Process the product and accessories appropriately before disposal.
2.2 Technical condition
A damaged device or components can injure patients, users and third parties.
▶Use the device and components only if there is no damage on the outside.
▶Check to make sure that the device is working properly and is in satisfac-
tory condition before each use.
▶Have parts with sites of breakage or surface changes checked by the Ser-
vice.
▶If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage
▪ Irregular running noise
▪ Excessive or nor enough vibration
▪ Overheating
▪ SonicFill Unidose Tip is not seated firmly in the handpiece
To ensure optimum function and to prevent property damage, please comply
with the following instructions:
▶Service the medical device with care products and systems regularly as de-
scribed in the instructions for use.
▶The device should be cleaned, serviced and stored in a dry location, accord-
ing to instructions, if it is not to be used for an extended period of time.
2.3 Application
Risk of suffocation: to prevent the patient from swallowing or aspirating the
SonicFill Unidose Tip, please note the following:
▶Place a rubber dam before each treatment involving the SonicFill handpiece.

2 Safety | 2.4 Accessories and combination with other equipment
▶Check the tool for secure attachment before treatment.
2.4 Accessories and combination with other equipment
Use of un-authorized accessories on the device or un-authorized modifications
to the device can 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 standardized interfaces.
▶Do not make any modifications to the product.
▶Use the SonicFill handpiece exclusively in combination with the SonicFill
Unidose Tip for filling dental cavities with composite materials.
2.5 Qualification of personnel
Application of the product by users lacking appropriate medical training can in-
jure the patient, the user or third parties.
▶Make sure that the user has read and comprehends the instructions for use.
▶Only employ the device if the user has the appropriate medical training.
▶Comply with national and regional regulations.
2.6 Service and repair
Repairs, servicing and safety checks may only be performed by trained service
personnel. The following persons are authorized to do this:
▪ Service technicians of KaVo Kerr branches after the appropriate product
training
▪ Service technicians of KaVo Kerr-authorized dealers after the appropriate
product training
Comply with the following items during all servicing work:
▶Have the service and testing tasks carried out in accordance with the autho-
rized personal.
▶Have the medical device evaluated by a professional shop with regard to its
cleaning, servicing and functional needs according to an in-house service in-
terval. Define the service interval depending on the frequency of use.
9 / 46

3 Description of the product | 3.1 Intended use
10 / 46
3 Description of the product
SonicFill handpiece
The SonicFill handpiece is a dental handpiece in accordance with ISO 15606.
The handpiece is designed for sound-activated dispensation of any easy flowing
composite material. During the dispensing process, the composite material
quickly transforms into a more viscous state of a non-tacky, shape-stable com-
posite.
3.1 Intended use
Indications for use:
The SonicFill handpiece is a dental delivery system intended to be used to dis-
pense SonicFill, a dental restorative resin, directly into dental cavities.
The medical device is intended for the following uses only:
▪ Dental treatments in the scope of dentistry
▪ All other types of use or modifications of the product are not permitted and
can be hazardous
▪ The SonicFill handpiece may be used exclusively in combination with the
SonicFill Unidose Tips for filling dental cavities with composite materials
▪ The SONICFill handpiece is a medical device in accordance with the relevant
national statutory regulations
CAUTION
US Federal law restricts this device to sale by or on the order of a
healthcare professional / dentist.
For dental use only.
Proper Use:
In accordance with these regulations, this medical device is intended only for
the described use and by expert users in compliance with:
▪ the applicable occupational safety regulations,
▪ the applicable accident prevention regulations
▪ and these instructions for use.
In accordance with these regulations, the user is required to
▪ only use equipment that is operating properly,
▪ comply with the proper intended use,
▪ protect himself or herself, the patient and third parties from danger,
▪ avoid contamination from the product.

3 Description of the product | 3.2 Technical Specifications
3.2 Technical Specifications
Drive air 3 – 4.2 bar (43 – 61 psi)
Air consumption 20 – 40 NL/min
Frequency 5 – 6 kHz
Ejection force 0 to 170 N
The handpiece works optimally if the treatment unit is set to a pressure of 2.1 -
3.5 bar (30-50 psi).
See also:
24.3 Checking the pressures, Page 13
Can be attached to all MULTIflex (LUX) / MULTIflex LED couplings.
3.3 Transportation and storage conditions
▶Do not store in a refrigerated environment.
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 (Keep dry)
11 / 46

4 Startup and shut-down | 4.1 Installing the MULTIflex coupling
12 / 46
4 Startup and shut-down
Mediated by a MULTIflex coupling, the SonicFill handpiece can be connected to
any high speed air handpiece hose of a treatment center.
WARNING
Hazard from non-sterile products.
Infection hazard for dentist and patient.
▶Prior to initial startup and after each use, process the product and
accessories.
See also:
26 Processing steps in accordance with ISO 17664, Page 16
WARNING
Dispose of the product in the appropriate manner.
Infection hazard.
▶Process the product and accessories before disposal.
See also:
26 Processing steps in accordance with ISO 17664, Page 16
NOTICE
Damage from contaminated and moist cooling air.
Contaminated and moist cooling air can cause malfunctions.
▶Make sure that the supplied cooling air is dry, clean and free of contamina-
tion in accordance with 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 (LUX) / MULTIflex LED coupling onto the high speed
air handpiece hose and tighten with the wrench.
4.2 Checking the O-rings
NOTICE
Missing or damaged O-rings.
Malfunctions and premature failure.
▶Make sure that all O-rings are present on the coupling and are undamaged.
Number of available O-rings: 5

4 Startup and shut-down | 4.3 Checking the pressures
4.3 Checking the pressures
NOTICE
Contaminated or moist compressed air at the compressed air connec-
tion.
Premature wear.
▶Supply dry, clean and uncontaminated compressed air in accordance with
ISO 7494-2 only.
A minimum drive pressure of 3 bar (43 psi) measured at the handpiece is re-
quired 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. In-
sert the test manometer between the MULTIflex coupling and the SonicFill
handpiece. Set the regulating ring to 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.
13 / 46

5 Operation | 5.1 Attaching the SonicFill handpiece
14 / 46
5 Operation
5.1 Attaching the SonicFill handpiece
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.
NOTICE
Inaccurate coupling can destroy the high-pressure lamp or the LED of the cou-
pling or reduce its service life.
▶Make sure that the handpiece is accurately coupled and firmly seated on
the coupling.
▶Place the SonicFill accurately on the MULTIflex (LUX) / MULTIflex LED cou-
pling and push it to the rear until it audibly locks.
5.2 Pulling off the SonicFill handpiece
NOTICE
The coupling system is fitted with light.
Defects on the light source.
▶Wait at least 5 seconds before you take off the SonicFill handpiece.
▶Holding on to the SonicFill Multiflex coupling, pull off the SonicFill handpiece
forward while twisting it slightly.
5.3 Inserting the SonicFill Unidose Tips
WARNING
Swallowing or aspiration of loose parts or substances by the patient.
Danger of suffocation.
▶Use SonicFill Unidose Tips only.
▶Make sure that the SonicFill Unidose Tips are easy to screw on and to un-
screw.
▶Before each treatment, pull on the SonicFill Unidose Tip to see if it is se-
curely attached to the handpiece.
▶Right before the treatment, briefly start the SonicFill handpiece outside the
mouth for a test run.
▶Place a rubber dam before each treatment.

5 Operation | 5.4 Removing the SonicFill Unidose Tips
NOTICE
Use SonicFill Unidose Tips for treatment only.
Product damage.
▶Make sure that the SonicFill Unidose Tip was easy to screw on.
▶Check the SonicFill Unidose Tip for secure attachment before each treat-
ment.
▶Right before the treatment, briefly start the SonicFill handpiece outside the
mouth for a test run.
▶Push the SonicFill Unidose Tips by hand into the corresponding opening of
the SonicFill handpiece using moderate pressure and then screw the Sonic-
Fill handpiece by clockwise turns into the SonicFill Unidose Tips.
5.4 Removing the SonicFill Unidose Tips
▶Unscrew the SonicFill Unidose Tips by hand from the SonicFill handpiece
through a counterclockwise rotation.
5.5 Power setting
▶Use the regulating ring of the SonicFill to adjust the dispensed quantity.
ðLevel 1 = low
ðLevel 5 = high
Note
Dispensing with a variable foot control (e.g. KaVo multi-function foot
control):
Variable foot controls allow the dispensing rate to be controlled by different
positions of the foot pedal. Using a KaVo foot control, the maximum dis-
pensed volume is reached with the pedal position towards the right, whereas
a pedal position towards the left reduces the volume. To control the dispens-
ing rate with the foot control, the regulating ring on the handpiece should be
set to 5.
15 / 46

6 Processing steps in accordance with ISO 17664 | 6.1 Preparations at the site of use
16 / 46
6 Processing steps in accordance with ISO 17664
6.1 Preparations at the site of use
WARNING
Hazard from contaminated products
Contaminated products are associated with an infection risk.
▶Take suitable personal protective measures.
▶Process the medical device as soon as possible after treatment.
▶To minimize the risk of infection during processing, always wear protective
gloves.
▶Remove the SonicFill Unidose Spitze from the medical device.
▶Remove all residual cement, composite or blood immediately.
▶Do not immerse in solutions or the like.
6.2 Preparations before cleaning
▶Remove the SonicFill Unidose Tip by hand from the SonicFill handpiece.
6.3 Manual processing
NOTICE
Never process this medical device in an ultrasonic device.
Functional damage and property damage.
▶Clean manually or in a washer disinfector only.
6.3.1 Manual external cleaning
Accessories required:
▪ Tap water
▪ Brush, e.g. medium-hard toothbrush
▶Brush under running tap water using, e.g., a medium-hardness toothbrush.
6.3.2 Manual external disinfection
WARNING
Incomplete disinfection.
Infection hazard.
▶Only use disinfection procedures that are verified to be bactericidal, fungici-
dal 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 steril-
izer.

6 Processing steps in accordance with ISO 17664 | 6.4 Automated processing
NOTICE
Never disinfect the handpiece with chlorine-containing products.
Functional damage and property damage.
▶Only disinfect in a washer disinfector or manually.
KaVo Kerr recommends the following products based on the compatibility of
the materials. The microbiological efficacy must be ensured by the disinfectant
manufacturer and proven by an expert opinion.
Approved disinfectants:
▪ CaviWipes and 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 in accordance with the instructions of the
disinfectant manufacturer.
▶Comply with the instructions for use of the disinfectant.
6.3.3 Manual drying
▶Clean the outside and inside with compressed air until no drops of water are
visible.
▶Immediately after drying, lubricate the KaVo medical device with care
agents from the KaVo care system.
See also:
26.5 Care products and systems - Servicing , Page 18
6.4 Automated processing
WARNING
Incomplete disinfection.
Infection hazard.
▶Only use disinfection procedures that are verified to be bactericidal, fungici-
dal 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 steril-
izer.
NOTICE
Never disinfect the handpiece with chlorine-containing products.
Functional damage and property damage.
▶Only disinfect in a washer disinfector or manually.
NOTICE
Never process this medical device in an ultrasonic device.
Functional damage and property damage.
▶Clean manually or in a washer disinfector only.
17 / 46

6 Processing steps in accordance with ISO 17664 | 6.5 Care products and systems - Servicing
18 / 46
6.4.1 Automated internal and external cleaning and
internal and external disinfection
KaVo Kerr recommends washer disinfectors in accordance with ISO 15883-1,
which are operated using alkaline cleaning agents.
▶For program settings as well as cleansers and disinfectants to be used,
please refer to the Instructions for Use of the washer disinfector.
6.4.2 Automated drying
The drying procedure is usually part of the cleaning program of the washer dis-
infector.
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.
▶Immediately after drying, lubricate the KaVo medical device with care
agents from the KaVo care system.
6.5 Care products and systems - Servicing
CAUTION
Improper service and care.
Risk of injury.
▶Perform regular proper care and servicing.
Note
KaVo Kerr only guarantees the proper function of KaVo Kerr products if the
care products listed by KaVo Kerr as expedients are used, since these prod-
ucts have been tested for proper use on KaVo Kerr products.
6.5.1 Servicing with a lubrication spray and a MULTIflex
coupling
KaVo Kerr recommends servicing the product as part of the processing after
each use, i.e. after each cleaning, disinfection, and before each sterilization.
Note
If the oil leakage is bothersome, once weekly servicing is sufficient.
▶Remove the SonicFill Unidose Tip.
▶Cover the product with the cellulose bag.
▶Place the product on the SonicFill MULTIflex coupling ①, and press the
spray button for one second.

6 Processing steps in accordance with ISO 17664 | 6.6 Packaging
6.6 Packaging
Note
The sterile goods package must be large enough for the handpiece so that
the packaging is not stretched.
The quality and use of the sterile goods package must meet the applicable
standards and be appropriate for the sterilization process!
▶Seal each medical device individually in a sterilization item package.
6.7 Sterilization
Sterilization in a steam sterilizer (autoclave) ISO
17665-1
CAUTION
Improper service and care.
Risk of injury.
▶Perform regular proper care and servicing.
NOTICE
Contact corrosion due to moisture.
Damage to the product.
▶Remove the product from the steam sterilization immediately after the
sterilization cycle.
Note
Remove the SonicFill Unidose Tip before sterilization. SonicFill
Unidose Tips cannot be sterilized.
The KaVo medical device has a maximum temperature resistance of up to
138℃ (280.4°F).
Sterilization parameters:
Select a suitable procedure (depending on the available autoclave) from the fol-
lowing sterilization processes:
▪ Sterilizer with triple pre-vacuum:
- at least 3 minutes at 135°C (275 °F)
- Drying time: 16 min.
▪ Sterilizer with single pre-vacuum:
- at least 4 minutes at 132°C (270 °F)
- Drying time: 20 min.
▪ Sterilizer using the gravity method:
- at least 30 minutes at 121°C (250 °F)
- Drying time: 15 min.
▶Use in accordance with the manufacturer's Instructions for Use.
6.8 Storage
Processed products must be stored, protected from bacteria, to the extent pos-
sible, and dust, in a dry, dark, cool room.
19 / 46

6 Processing steps in accordance with ISO 17664 | 6.8 Storage
20 / 46
Note
Comply with the expiration date of the sterilized items.