KERR SonicFill User manual

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