KaVo Kerr SonicFill Multiflex coupling User manual

Instructions for use
SonicFill Multiflex coupling - 35134

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............................................................................................................................... 23

Table of contents
1 User instructions ................................................................................................................ 6
2 Safety.................................................................................................................................. 8
2.1 Infection hazard ............................................................................................................ 8
2.2 Technical condition......................................................................................................... 8
2.3 Accessories and combination with other equipment........................................................... 8
2.4 Qualification of personnel................................................................................................ 8
2.5 Service and repair.......................................................................................................... 9
3 Product description ............................................................................................................10
3.1 Intended use................................................................................................................. 10
3.2 Technical Specifications.................................................................................................. 10
3.3 Transportation and storage conditions.............................................................................. 11
4 Startup................................................................................................................................12
5 Operation............................................................................................................................13
5.1 Connecting the SonicFill Multiflex coupling to the hose....................................................... 13
5.2 Removing the SonicFill Multiflex coupling from the hose..................................................... 13
5.3 Attaching the SonicFill handpiece..................................................................................... 13
5.4 Pulling off the SonicFill handpiece .................................................................................... 14
6 Checking for malfunctions and troubleshooting ................................................................15
6.1 Checking for malfunctions before initial startup................................................................. 15
6.2 Troubleshooting............................................................................................................. 15
6.2.1 Replacing the O-rings.......................................................................................... 15
7 Processing steps in accordance with ISO 17664 ...............................................................16
7.1 Preparations at the site of use......................................................................................... 16
7.2 Manual processing ......................................................................................................... 16
7.2.1 Manual cleaning - external................................................................................... 16
7.2.2 Manual internal cleaning...................................................................................... 16
7.2.3 Manual external disinfection................................................................................. 16
7.2.4 Manual internal disinfection.................................................................................. 17
7.2.5 Manual drying .................................................................................................... 17
7.3 Automated processing.................................................................................................... 17
7.3.1 Automated internal and external cleaning and internal and external disinfection........ 17
7.3.2 Automated drying............................................................................................... 17
7.4 Sterilization................................................................................................................... 18
7.5 Storage ........................................................................................................................ 18
8 Tools and consumables ......................................................................................................19
9 Terms and conditions of warranty .....................................................................................20
Table of contents
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1 User instructions
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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
Suitable for disinfection in a washer disinfector
Non-sterilizable
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
Caution: Consult instructions for use
EAC conformity mark (Eurasian Conformity)
GOST R certification

1 User instructions
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.
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2 Safety | 2.1 Infection hazard
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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.
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 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.
2.4 Qualification of personnel
Application of the product by users lacking appropriate medical training can in-
jure the patient, the user or third parties.

2 Safety | 2.5 Service and repair
▶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.
2.5 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.
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3 Product description | 3.1 Intended use
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3 Product description
SonicFill Multiflex coupling (Kerr no. 35134)
3.1 Intended use
Indications for use:
The SonicFill Multiflex coupling is an accessory for the medical device and de-
signed for coupling the supply hose to Multiflex-compatible SonicFill handpieces.
All other types of use or modifications of the product are not permitted and can
be hazardous.
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:
According to these provisions, the SonicFill Multiflex coupling must be used by
expert users and for the specified application exclusively. You need to comply
with the following:
▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
▪ these Instructions for use
In accordance with these regulations, the user is required to:
▪ only use equipment that is operating properly
▪ adhere to the specified intended use
▪ protect himself or herself, the patient and third parties from danger
▪ avoid contamination from the product
3.2 Technical Specifications
The SonicFill Multiflex coupling can be attached to all hoses with a 4-hole stan-
dard connection.
No spray regulation on the coupling.
The SonicFill handpiece (Kerr no. 34920) can be attached.

3 Product description | 3.3 Transportation and storage conditions
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)
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4 Startup
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4 Startup
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:
27 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:
27 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.

5 Operation | 5.1 Connecting the SonicFill Multiflex coupling to the hose
5 Operation
Note
At the beginning of each workday, the water-conducting systems should be
rinsed for at least 2 minutes (without transmission handpieces being at-
tached) and if there is a risk of contamination from reflux or back suction, the
system may also need to be rinsed for 20-30 seconds after each patient.
5.1 Connecting the SonicFill Multiflex coupling to the
hose
▶Plug the SonicFill Multiflex coupling onto the turbine hose and secure it
tightly with the union nut screw of the hose.
▶Re-tighten with the enclosed wrench.
▶Lightly spray SonicFill handpiece lubrication spray on the O-rings.
The coupling remains screwed onto the hose.
5.2 Removing the SonicFill Multiflex coupling from the
hose
▶In order to remove the coupling rotate the sleeve of the hose in counter-
clockwise direction and use the wrench to take the coupling off the hose.
5.3 Attaching the SonicFill handpiece
WARNING
Detachment of the medical device during treatment.
A medical device that is not properly locked can detach from the SonicFill Multi-
flex coupling during the treatment.
▶Before each use, check if the medical device is securely locked onto the
SonicFill Multiflex coupling by pulling on it.
▶Place the SonicFill handpiece exactly on the SonicFill Multiflex coupling and
push it to the rear until it audibly locks in place.
▶Pull on the SonicFill handpiece to check if it is securely seated on the cou-
pling.
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5 Operation | 5.4 Pulling off the SonicFill handpiece
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5.4 Pulling off the SonicFill handpiece
▶Holding on to the SonicFill Multiflex coupling, pull off the SonicFill handpiece
forward while twisting it slightly.

6 Checking for malfunctions and troubleshooting | 6.1 Checking for malfunctions before initial startup
6 Checking for malfunctions and troubleshooting
6.1 Checking for malfunctions before initial startup
NOTICE
Missing or damaged O-rings.
Malfunctions and premature failure.
▶Make sure that all O-rings are present on the coupling and are undamaged.
Note
Stop working if the O-ring is missing or damaged.
Number of O-rings: 5
6.2 Troubleshooting
6.2.1 Replacing the O-rings
NOTICE
Improper care of the O-rings.
Malfunction or complete failure.
▶Do not use Vaseline or other grease or oil.
Note
The O-rings on the coupling may only be lubricated with a cotton ball wetted
with SonicFill Handpiece Lubrication Spray.
▶Replacing the O-rings, if the coupling becomes leaky.
▶Press the O-ring between your fingers to form a loop.
▶Push the O-ring to the front, and remove it.
▶Insert the new O-rings in the recesses and wet them using a cotton ball
soaked with SonicFill Handpiece Lubrication Spray.
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7 Processing steps in accordance with ISO 17664 | 7.1 Preparations at the site of use
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7 Processing steps in accordance with ISO 17664
7.1 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.
▶The medical device must be dry when transported to processing.
▶To minimize the risk of infection during processing, always wear protective
gloves.
▶Remove all residual cement, composite or blood immediately.
▶Do not immerse in solutions or the like.
7.2 Manual processing
NOTICE
Never process this medical device in an ultrasonic device.
Functional damage and property damage.
▶For manual cleaning only.
7.2.1 Manual cleaning - external
Accessories required:
▪ Tap water
▪ Brush, e.g. medium-hard toothbrush
▶Brush under flowing tap water.
7.2.2 Manual internal cleaning
Not applicable.
7.2.3 Manual external disinfection
NOTICE
Malfunctioning from using a disinfectant bath or chloride-containing
disinfectants.
Defects on the product.
▶For manual disinfection only!
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.

7 Processing steps in accordance with ISO 17664 | 7.3 Automated processing
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.
7.2.4 Manual internal disinfection
Not applicable.
7.2.5 Manual drying
▶Clean the outside and inside with compressed air until no drops of water are
visible.
7.3 Automated processing
NOTICE
Never process this medical device in an ultrasonic device.
Functional damage and property damage.
▶For manual cleaning only.
NOTICE
Malfunctioning from using a disinfectant bath or chloride-containing
disinfectants.
Defects on the product.
▶For manual disinfection only!
7.3.1 Automated internal and external cleaning and
internal and external disinfection
Not applicable.
7.3.2 Automated drying
Not applicable.
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7 Processing steps in accordance with ISO 17664 | 7.4 Sterilization
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7.4 Sterilization
Non-sterilizable.
7.5 Storage
Processed products must be stored, protected from bacteria, to the extent pos-
sible, and dust, in a dry, dark, cool room.

8 Tools and consumables
8 Tools and consumables
Obtainable from an authorized Kerr distributor.
Material summary Kerr Mat. no.
Wrench 80463
Spare washer 35145
O-ring 35146
O-ring 35147
SonicFill Spray can 35207
Set of SonicFill Spray cans 35127
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9 Terms and conditions of warranty
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9 Terms and conditions of warranty
LIMITED WARRANTY
LIMITATION OF KERR'S LIABILITY
The technical recommendations made by Kerr, whether in written or oral form,
are intended to make the use of Kerr products easier for the dentist. These rec-
ommendations do not affect the limitations of Kerr's liability and do not release
the dentist from the obligation to check the applications and methods with re-
gard to the intended purposes of use of Kerr products. The dentist shall bear all
of the risk and all of the liability with regard to damage resulting from incorrect
use of a Kerr product. In case of defects of materials or workmanship, the liabil-
ity of Kerr shall be limited to replacement of the defective product or product
component or (at Kerr's discretion) reimbursement of the price of the defective
product provided it has been paid. In order to make claims under the present
limited warranty, the defective product must be returned to Kerr by mail. Kerr
shall in no case be liable for indirect damage, incidental damage or secondary
damage. WITH THE EXCEPTION OF THE AFOREMENTIONED, KERR PROVIDES
NO OTHER GUARANTEES, WHETHER IT BE EXPRESSLY OR IMPLICITLY; AND
NO GUARANTEES WITH REGARD TO THE DESCRIPTION, QUALITY OR SUIT-
ABILITY FOR THE INTENDED USE.