KERR ENDODONTICS elements 8:1 User manual

Instructions for use
elements™ 8:1

Manufactured for:
Kerr Corporation
1717 West Collins Avenue
Orange CA 92867
U.S.A.
+1-800-KERR-123
www.kerrdental.com
Manufacturer:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
www.kavo.com
Distributed by:
Kerr Australia Pty. Limited
Unit 6, 12 Mars Road
Lane Cove West, New South Wales 2066
Australia
[phone]
Importer
Ormco B.V.
Basicweg 20 NL-3821 BR
Amersfoort, The Netherlands
PN: 077-1115
03/2021
Rev. C

Table of contents
1 User instructions ................................................................................................................ 4
2 Safety.................................................................................................................................. 7
2.1 Infection hazard ............................................................................................................ 7
2.2 Improper use ................................................................................................................ 7
2.3 Technical condition ........................................................................................................ 7
2.4 Accessories and combination with other equipment........................................................... 8
2.5 Qualification of personnel ............................................................................................... 8
2.6 Service and repair ........................................................................................................ 9
3 Description of the product.................................................................................................. 10
3.1 Intended use.................................................................................................................11
3.2 Technical Specifications.................................................................................................. 11
3.3 Symbols on product and rating plate ............................................................................... 12
3.4 Transportation and storage conditions ............................................................................. 13
4 Startup and shut down ......................................................................................................14
5 Operation............................................................................................................................ 15
5.1 Attaching the medical device .......................................................................................... 15
5.2 Removing the medical device.......................................................................................... 15
5.3 Inserting the bur ........................................................................................................... 15
5.4 Removing the burs ........................................................................................................ 17
6 Checking for malfunctions and troubleshooting ................................................................18
6.1 Check for malfunctions................................................................................................... 18
6.2 Troubleshooting ............................................................................................................ 18
6.2.1 Replacing O-rings on the motor coupling .............................................................. 18
7 Processing steps in accordance with ISO 17664 ...............................................................20
7.1 Preparations at the site of use......................................................................................... 20
7.2 Manual processing .........................................................................................................20
7.2.1 Manual external cleaning .................................................................................... 20
7.2.2 Manual internal cleaning ..................................................................................... 20
7.2.3 Manual external disinfection ................................................................................ 21
7.2.4 Manual internal disinfection ................................................................................. 21
7.2.5 Manual drying.................................................................................................... 21
7.3 Automated processing.................................................................................................... 22
7.3.1 Automated internal and external cleaning and internal and external disinfection ....... 22
7.3.2 Automated drying .............................................................................................. 22
7.4 Care products and systems - Servicing ............................................................................ 23
7.4.1 Servicing with KaVo Spray ................................................................................. 23
7.4.2 Servicing with KaVo QUATTROcare PLUS .............................................................. 23
7.5 Packaging ..................................................................................................................... 24
7.6 Sterilization................................................................................................................... 24
7.7 Storage ........................................................................................................................ 25
8 Tools and consumables ......................................................................................................26
9 Terms and conditions of warranty .....................................................................................27
Instructions for use elements™ 8:1
Table of contents
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Instructions for use elements™ 8:1
1 User instructions
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1 User instructions
Dear User,
congratulations on purchasing this Kerr Endodontics product. By following the
instructions below you will be able to work smoothly, economically and safely.
KaVo and elements 8:1 are either registered trademarks or trademarks of KaVo
Dental GmbH.
All other trademarks are property of their respective owners.
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
Email: [e-mail]
General marks and symbols
See Chapter on User Instructions/Hazard Levels
Important information for users and service technicians
Action request
Medical device, labeling of medical devices
Sterilization parameters
▪ Sterilizer with triple pre-vacuum:
- at least 3 minutes at 135°C (275 °F)
- Drying time: 16 min.
▪ Sterilizer using the gravity method:
- at least 10 minutes at 135°C (275 °F)
- Drying time: 30 min.
▪ Sterilizer using the gravity method:
- at least 60 minutes at 121°C (250 °F)
- Drying time: 15 min.
Thermodisinfectable
Information on the packaging
Follow instructions for use
Please note the instructions for use
Caution

Instructions for use elements™ 8:1
1 User instructions
Temperature range
Air pressure
Relative humidity
Rx
only
Caution: Federal (US) law restricts the sale of the device by or on the
order of a dentist.
CE mark (European Conformity mark)
Medical device, labeling of medical devices
Importer
Transport upright with the arrows pointing upwards!
Fragile - protect against impact!
Stacking limit by number
Protect from moisture (Keep dry)!
Do not dispose this product into the ordinary municipal waste or
garbage system
Properly dispose of non-corrugated fiberboard
Properly dispose of polyethylene
Properly dispose of all other plastics such as polycarbonate (PC),
polyamide (PA), styrene acrylonitrile (SAN), polymethylmethacrylate
(PMMA), polylactides (PLA), etc.
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.
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Instructions for use elements™ 8:1
1 User instructions
6 / 30
CAUTION
In cases which – if not prevented – can lead to minor or moderate in-
jury.
NOTICE
In cases which – if not prevented – can lead to property damage.

Instructions for use elements™ 8:1
2 Safety | 2.1 Infection hazard
2 Safety
Note
All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.
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.
▶In the case of injury to soft tissue, do not continue treatment in the oral
cavity with instruments driven by compressed air.
▶To test, use and remove the tool, use a glove or finger guard.
2.2 Improper use
Improper use of the device can lead to burns or injuries.
▶Check the technical condition before each use.
See also:
22.3 Technical condition, Page 7
▶Never press the push-button during operation of the device.
▶Never use the instrument to keep the cheek, tongue or lip at a distance.
▶Never touch the handpiece head or handpiece lid to soft tissue.
▶Do not use the medical device as a light probe.
▶Use an appropriate light probe for illumination of the oral cavity or site of
preparation.
▶After treatment, place the medical device properly in the cradle without the
tool.
2.3 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.
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Instructions for use elements™ 8:1
2 Safety | 2.4 Accessories and combination with other equipment
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▶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 vibration
▪ Overheating
▪ Tool 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 product should be processed and stored in a dry location, according to
instructions, if it is not to be used for an extended period of time.
High torque of micromotors can lead to severe burn injuries.
▶Service micromotors regularly.
▶Do no use any damaged motors.
▶Do not use motors for unauthorized purposes.
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 device unless these have been ap-
proved by the manufacturer of the product.
The lack of control equipment for changing the speed range and the direction of
rotation can lead to injury.
▶Control facility for changing the speed and the direction of rotation must be
present.
▶The medical device may only be combined with a treatment centre / control
unit released by KaVo.
▶Comply with the Instructions for Use of the treatment center / control unit.
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.

Instructions for use elements™ 8:1
2 Safety | 2.6 Service and repair
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 branches after the appropriate product training
▪ Service technicians of KaVo 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.
▶Following expiration of the warranty, have the tool holding system checked
once a year.
▶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.
As a result of the use of NON-KaVo original spare parts during the repair, parts
such as covers may become undone and injure the patient, user or other peo-
ple. This may result in aspiration, swallowing of parts and possibly even a risk
of suffocation.
▶Only use spare parts that comply with the specification for repair; original
KaVo spare parts comply with the specification.
Note
If a repair is done with NON-KaVo original spare parts, this may constitute a
product modification that leads to the loss of CE conformity. In the event of
damage, the responsibility is with the service company or the operator.
The introduction into the market of a modified product, where there is rea-
sonable suspicion that the safety and health of patients or users may be
jeopardized, is prohibited by the German medical device law §4, section 1 no.
1 and requires a separate conformity check.
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Instructions for use elements™ 8:1
3 Description of the product | 2.6 Service and repair
10 / 30
3 Description of the product
elements™ 8:1, PN: 815-1655
The elementsTM 8:1 electrical-driven handpiece is a dental handpiece according
to 21 CFR § 872.4200 (dental handpieces and accessories) for the use by a
trained professional in the field of general dentistry.
The device is a electrical-powered handpiece that is reusable and ergonomically
shaped. The handpiece can be sterilized in a steam sterilizer (autoclave).
Through the tube and the electrical motor connected to a dental unit, the ele-
mentsTM 8:1 handpiece equipped with a handpiece connection according to ISO
3964 receive the energy for the gear, the cooling water and air for cutting
treatment. Dental burs and other attachments according to ISO 1797-1 will be
used with the elementsTM 8:1 handpiece. Based on the INTRAmatic connection
that meets the ISO 3964 the elementsTM 8:1 handpiece fit with any electrical
dental motor which is produced in accordance to this standard. The electrical
motors carry the energy for the gear, the cooling water and air for cutting
treatment from the dental treatment unit to the elementsTM 8:1 handpiece.

Instructions for use elements™ 8:1
3 Description of the product | 3.1 Intended use
3.1 Intended use
Indications for use:
The elementsTM 8:1 handpiece is intended for the removal of carious material,
reducing of hard tooth structure, cavity and crown preparations, root canal
preparations, removal of fillings, processing and finishing tooth preparations,
restorations, and for polishing teeth. The elementsTM 8:1 handpiece is designed
for use by a trained professional in the field of general dentistry.
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 regulations, this product may only be used for the described
application by a properly trained user. 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
Drive speed max. 40,000 rpm
Speed transmission: 8:1
Cooling air flow 5.5 to 9.5 Nl/min
With push-button chuck.
Contra-angle burs and root canal instruments can be inserted.
The contra-angle handpiece can be mounted on all INTRAmatic (LUX) motors
and motors fitted with a connector in accordance with ISO 3964 / DIN 13940.
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Instructions for use elements™ 8:1
3 Description of the product | 3.3 Symbols on product and rating plate
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3.3 Symbols on product and rating plate
The rating plates are affixed to the underside of the unit.
Accompanying documents
Caution
Follow instructions for use
Please note the instructions for use
Please note the electronic instructions for use
Certification
CE mark (Communauté Européenne)
Medical device, labeling of medical devices
Product characteristics
Manufacturer
Type Device type
SN Serial number
REF Catalog number
Type B applied part
Supply voltage
Operating mode: continuous operation with intermittent load
Class II, n equipment
Do not dispose this product into the ordinary municipal waste or
garbage system

Instructions for use elements™ 8:1
3 Description of the product | 3.4 Transportation and storage conditions
3.4 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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Instructions for use elements™ 8:1
4 Startup and shut down
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4 Startup and shut down
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.
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 20
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.
NOTICE
Damage to the medical device caused by spray air and spray water.
Property damage
▶Un-select spray air and spray water on the supply unit before startup!

Instructions for use elements™ 8:1
5 Operation | 5.1 Attaching the medical device
5 Operation
5.1 Attaching the medical device
CAUTION
Detachment of the medical device during treatment.
Injury or property damage
A medical device that is not properly locked in place can become disconnected
from the motor coupling and fall off.
▶Carefully pull on the medical device before each treatment to make sure
that it is securely locked onto the motor coupling.
NOTICE
Removing and attaching the medical device while the drive motor is
rotating.
Damage to the driver.
▶Never attach or remove the medical device while the drive motor is rotat-
ing.
NOTICE
Pressing the foot switch while attaching or detaching the medical de-
vice.
Property damage to the medical device.
▶Do not connect or remove the medical device while pressing the foot
switch.
▶Lightly spray O-rings on the motor coupling with KaVo Spray.
▶Attach the medical device to the motor coupling and lock it into place.
▶Pull on the medical device to make sure that it is securely affixed to the
coupling.
5.2 Removing the medical device
▶Unlock the medical device from the motor coupling by twisting it slightly
and then pulling it along its axis.
5.3 Inserting the bur
Note
Only use root canal instruments with shafts that comply with ISO 1797-1
type 1 and ISO 3630-1:
- Shaft diameter: Ø 2.334 to Ø 2.350 mm
- Shaft clamping length: min. 12mm
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Instructions for use elements™ 8:1
5 Operation | 5.3 Inserting the bur
16 / 30
WARNING
Use of unauthorized burs.
Risk of injury.
▶Comply with the instructions for use and the intended use of the bur.
▶Only use burs that do not deviate from the specified data.
WARNING
Hazard from rotating bur.
Lacerations.
▶Do not touch rotating bur!
▶Remove the bur from the medical device after treatment to avoid injury
and infection during storage.
CAUTION
Bur with worn or damaged shafts.
Risk of injury, bur may fall out during treatment.
▶Never use a bur with damaged or worn shafts.
CAUTION
Hazard from defective chucking system.
The bur can fall out and cause injury.
▶Pull on the bur to check if the chucking system is functioning properly and
that the bur is firmly clamped. Wear gloves or a finger guard when you
check, insert or remove the bits to prevent injury and infection.
NOTICE
Bur shaft slips inside the chuck due to excessive speed of the bur or
abrupt engagement of the bur.
Property damage to bur shaft and chuck system, reduction of the service life of
bur and chuck system.
▶Do not operate the bur at a higher speed than recommended by the manu-
facturer.
NOTICE
Bur with worn or damaged shafts.
Property damage to the chuck system, bur is difficult or impossible to remove
from the chuck system.
▶Never use a bur with damaged or worn shafts.
▶Insert the bur into the segment of the head drive by twisting the bur
slightly, and push it to the bur stop.
▶Make sure that the bur is seated securely by pulling on it.

Instructions for use elements™ 8:1
5 Operation | 5.4 Removing the burs
5.4 Removing the burs
WARNING
Hazard from rotating bur.
Lacerations and damage to the chuck system.
▶Do not touch rotating bur!
▶Never push the push-button while the bur is rotating!
▶Remove the bur from the medical device after treatment to avoid injury
and infection during storage.
▶After the bur has stopped rotating, press the push-button down with your
thumb and simultaneously remove the bur.
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Instructions for use elements™ 8:1
6 Checking for malfunctions and troubleshooting | 6.1 Check for malfunctions
18 / 30
6 Checking for malfunctions and troubleshooting
6.1 Check for malfunctions
CAUTION
Product heats up.
Burn injury or product damage due to over-heating.
▶Do not continue working if the product heats up irregularly.
NOTICE
Missing or damaged O-rings.
Malfunctions and premature failure.
▶Make sure that all O-rings are present on the coupling and are undamaged.
▶The medical device overheats while idling:
Check the amount of cooling air.
▶The medical device overheats while working:
Service the medical device.
▶When the speed drops or is uneven:
Service the medical device.
▶Missing O-ring on the motor coupling:
Replace O-ring.
6.2 Troubleshooting
WARNING
Use of NON-KaVo original spare parts in the repair.
Parts such as covers can become undone and cause injury.
Aspiration, swallowing of parts, danger of suffocation.
▶Only use spare parts that comply with the specification for repair; original
KaVo spare parts comply with the specification.
Note
If a repair is done with NON-KaVo original spare parts, this may constitute a
product modification that leads to the loss of CE conformity. In the event of
damage, the responsibility is with the service company or the operator.
The introduction into the market of a modified product, where there is rea-
sonable suspicion that the safety and health of patients or users may be
jeopardized, is prohibited by the German medical device law §4, section 1 no.
1 and requires a separate conformity check.
6.2.1 Replacing O-rings on the motor coupling
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 motor coupling may only be lubricated with a cotton ball
wetted with KaVo Spray.
▶Press the O-ring between your fingers to form a loop.

Instructions for use elements™ 8:1
6 Checking for malfunctions and troubleshooting | 6.2 Troubleshooting
▶Push the O-ring to the front, and remove it.
▶Insert new O-rings into the grooves.
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Instructions for use elements™ 8:1
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.
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
▶Process the medical device as soon as possible after treatment.
▶To minimize the risk of infection during processing, always wear protective
gloves.
▶Remove the tool from the medical device.
▶Remove all residual cement, composite or blood immediately.
▶Do not immerse in solutions or the like.
7.2 Manual processing
WARNING
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶Remove the tool.
NOTICE
Never process this medical device in an ultrasonic device.
Functional damage and property damage.
▶Clean manually or in a washer disinfector only.
7.2.1 Manual external cleaning
Accessories required:
▪ Tap water
▪ Brush, e.g. medium-hard toothbrush
▶Brush under flowing tap water.
7.2.2 Manual internal cleaning
The interior of this product is not to be cleaned manually.