KERR Elements 8:1 User manual

Instructions for use
elements™ 8:1

Manufactured for:
Kerr Corporation
1717 West Collins Avenue
Orange CA 92867
U.S.
+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 ................................................................................................................ 5
2 Safety.................................................................................................................................. 8
2.1 Infection hazard ............................................................................................................ 8
2.2 Improper use ................................................................................................................ 8
2.3 Technical condition ........................................................................................................ 8
2.4 Accessories and combination with other equipment........................................................... 9
2.5 Qualification of personnel ............................................................................................... 9
2.6 Service and repair ......................................................................................................... 10
3 Product description ............................................................................................................11
3.1 Purpose – Intended use ................................................................................................. 12
3.2 Technical Specifications.................................................................................................. 12
3.3 Symbols on product and rating plate ............................................................................... 13
3.4 Transportation and storage conditions ............................................................................. 14
4 Startup and shut down.......................................................................................................15
5 Operation............................................................................................................................ 16
5.1 Attaching the medical device .......................................................................................... 16
5.2 Removing the medical device.......................................................................................... 16
5.3 Inserting the dental bur or diamond grinder ..................................................................... 16
5.4 Removing the milling tool or diamond grinder................................................................... 18
6 Checking for malfunctions and troubleshooting ................................................................19
6.1 Check for malfunctions................................................................................................... 19
6.2 Troubleshooting ............................................................................................................ 19
6.2.1 Replacing the O-rings on the motor coupling......................................................... 19
7 Reprocessing steps in accordance with ISO 17664 ...........................................................21
7.1 Preparations at the site of use......................................................................................... 21
7.2 Manual Reprocessing ..................................................................................................... 21
7.2.1 Manual external cleaning .................................................................................... 21
7.2.2 Manual internal cleaning ..................................................................................... 21
7.2.3 Manual external disinfection ................................................................................ 22
7.2.4 Manual internal disinfection ................................................................................. 23
7.2.5 Manual drying.................................................................................................... 23
7.3 Automated reprocessing................................................................................................. 24
7.3.1 Automated internal and external cleaning and internal and external disinfection ....... 24
7.3.2 Automated drying .............................................................................................. 24
7.4 Care products and systems - Servicing ............................................................................ 25
7.4.1 Servicing with KaVo Spray ................................................................................. 25
7.4.2 Servicing with KaVo QUATTROcare PLUS .............................................................. 25
7.4.3 Care with KaVo SPRAYrotor................................................................................. 26
7.4.4 Servicing with KaVo QUATTROcare ...................................................................... 27
7.5 Packaging ..................................................................................................................... 27
7.6 Sterilisation................................................................................................................... 28
7.7 Storage ........................................................................................................................ 28
8 Tools and consumables ......................................................................................................29
Instructions for use elements™ 8:1
Table of contents
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9 Terms and conditions of warranty .....................................................................................30
Instructions for use elements™ 8:1
Table of contents
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Instructions for use elements™ 8:1
1 User instructions
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]
Target group
This document is for dentists and dental office staff.
The section on startup is also intended for the service staff.
General marks and symbols
See Chapter on User Instructions/Hazard Levels
Important information for users and service technicians
Action request
CE mark (European Community). A product bearing this mark meets
the requirements of the applicable EC directive.
Medical device, labelling of medical devices
Can be steam-sterilised at 134 oC -1 oC / +4 oC (273 oF -1.6 oF / +7.4
oF)
Thermodisinfectable
Information on the packaging
Follow instructions for use
Please note the instructions for use
Caution
5 / 32

Instructions for use elements™ 8:1
1 User instructions
6 / 32
Temperature range
Air pressure
Relative Humidity
Rx
only
Caution: Federal (USA) law restricts device to sale by or on the order
of a dental professional.
CE mark (European Conformity mark)
Medical device, labelling 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), poly-
amide (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 material 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.

Instructions for use elements™ 8:1
1 User instructions
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 material damage.
7 / 32

Instructions for use elements™ 8:1
2 Safety | 2.1 Infection hazard
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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 could be infected by contaminated medical
devices.
▶Take suitable personal protective measures.
▶Follow the instructions for use of the components.
▶Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
▶Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
▶If you deviate from this procedure, it is essential to make sure that the re-
processing is effective.
▶Reprocess the product and accessories appropriately before disposal.
▶If there is any injury to soft tissue, do not continue treatment in the oral
cavity with compressed air-driven instruments.
▶Use gloves or finger guard whenever you test, insert, and remove the tool.
2.2 Improper use
The improper use of the device could lead to burns or injuries.
▶Check the technical condition before each use.
See also:
22.3 Technical condition, Page 8
▶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 soft tissue with the handpiece head or instrument cover.
▶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 could injure patients, users and third parties.
▶Only operate devices or components if they are undamaged on the outside.

Instructions for use elements™ 8:1
2 Safety | 2.4 Accessories and combination with other equipment
▶Check that the device is working properly and is in satisfactory 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
Observe the following instructions in order to guarantee optimum functioning
and prevent material damage:
▶Service the medical device with care products and systems regularly as de-
scribed in the instructions for use.
▶The device should be reprocessed and stored in a dry location, according to
instructions, if it is not be used for a longer period.
High torque of micromotors can lead to severe burn injuries.
▶Service micromotors regularly.
▶Do no use any damaged motors.
▶Do not use motors for unauthorised purposes.
2.4 Accessories and combination with other equipment
Use of un-authorised accessories or un-authorised modifications of the device
could 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 standardised 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
facility released by KaVo.
▶Comply with the Instructions for Use of the treatment centre / control unit.
2.5 Qualification of personnel
Application of the product by users without the appropriate medical training
could injure the patients, the users or third parties.
▶Make sure that the user has read and understood the instructions for use.
▶Only employ the device if the user has the appropriate medical training.
▶Observe national and regional regulations.
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Instructions for use elements™ 8:1
2 Safety | 2.6 Service and repair
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2.6 Service and repair
Repairs, servicing and safety checks may only be performed by trained service
personnel. The following persons are authorised to do this:
▪ Service technicians of KaVo branches after the appropriate product training
▪ Service technicians of KaVo authorised dealers after the appropriate product
training
Observe all the following items during servicing work:
▶Have the service and testing tasks carried out according to the Medical
Device Operator Ordinance.
▶Following expiry of the warranty, have the tool holding system checked
once a year.
▶KaVo recommends specifying in-house service intervals where the medical
device is brought to a professional shop for cleaning, servicing and a func-
tion check. 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
people. 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 reas-
onable suspicion that the safety and health of patients or users may be jeop-
ardised, is prohibited by the German medical device law §4, section 1 no. 1
and requires a separate conformity check.

Instructions for use elements™ 8:1
3 Product description | 2.6 Service and repair
3 Product description
elements™ 8:1, PN: 815-1655
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Instructions for use elements™ 8:1
3 Product description | 3.1 Purpose – Intended use
12 / 32
3.1 Purpose – Intended use
Indications for use:
This medical device is
▪ intended for dental treatment only. All other types of use of or modifications
to the product are not permitted and can be hazardous. The medical device
is intended for the following uses: cavity preparation and endodontics.
▪ A medical device according to relevant national statutory regulations.
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
According to these regulations, the user is required:
▪ to only use equipment that is operating correctly
▪ adhere to the specified intended use
▪ to protect him or herself, the patient and third parties from hazards
▪ to prevent 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 drills and root canal instruments can be inserted.
The contra-angle handpiece can be mounted on all INTRAmatic (LUX) motors
and motors with a connector in accordance with ISO 3964 / DIN 13940.

Instructions for use elements™ 8:1
3 Product description | 3.3 Symbols on product and rating plate
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
Consult instructions for use
Please note the electronic instructions for use
Certification
CE mark (Communauté Européenne)
Medical device, labelling of medical devices
Product characteristics
Manufacturer
Type Device type
SN Serial number
REF Material number
Type B applied part
Supply voltage
Operating mode: continuous operation with intermittent load
Class II equipment
Do not dispose this product into the ordinary municipal waste or
garbage system
13 / 32

Instructions for use elements™ 8:1
3 Product description | 3.4 Transportation and storage conditions
14 / 32
3.4 Transportation and storage conditions
NOTICE
Startup after refrigerated storage.
Malfunction.
▶Prior to startup, strongly refrigerated products must be allowed to warm up
to a temperature of 20 °C to 25 °C (68 °F to 77 °F).
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)

Instructions for use elements™ 8:1
4 Startup and shut down
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, reprocess the product and
accessories.
WARNING
Dispose of the product in appropriate manner.
Infection hazard.
▶Reprocess and sterilise the product and accessories before disposal.
See also:
27 Reprocessing steps in accordance with ISO 17664, Page 21
NOTICE
Damage from soiled and moist cooling air.
Contaminated and moist cooling air can cause malfunctions.
▶Make sure that the supply of cooling air is dry, clean, and uncontaminated
according to EN 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!
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Instructions for use elements™ 8:1
5 Operation | 5.1 Attaching the medical device
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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 ensure 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
device.
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.
▶Place the medical device on 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 dental bur or diamond grinder
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: at least 12 mm

Instructions for use elements™ 8:1
5 Operation | 5.3 Inserting the dental bur or diamond grinder
WARNING
Use of unauthorised dental burs.
Risk of injury.
▶Comply with the instructions for use and the intended use of the dental bur.
▶Only use dental bur that do not deviate from the specified data.
WARNING
Hazard from rotating dental bur.
Lacerations.
▶Do not touch the rotating dental bur!
▶Remove the dental burs from the medical device after treatment to avoid
injury and infection during storage.
CAUTION
Dental bur with worn or damaged shafts.
Risk of injury, dental bur may fall out during treatment.
▶Never use a dental bur with damaged or worn shafts.
CAUTION
Hazard from defective chuck system.
The dental bur can fall out and cause injury.
▶Pull on the dental bur to check if the clamping system works properly and if
the dental bur is firmly clamped. Wear gloves or a thimble when you check,
insert, or remove the bits to prevent injury and infection.
NOTICE
Dental bur shaft slips inside the chuck due to excessive speed of the
dental bur or abrupt engagement of the dental bur.
Material damage to dental bur shaft and chuck system, reduction of the service
life of dental bur and chuck system.
▶Do not operate the dental bur at a higher speed than recommended by the
manufacturer.
NOTICE
Dental bur with worn or damaged shafts.
Material damage to the chuck system, dental bur is difficult or impossible to re-
move from the chuck system.
▶Never use a dental bur with damaged or worn shafts.
▶Insert the dental bur into the segment of the head drive by twisting the
dental bur slightly, and push it to the end stop.
▶Check if the dental bur is seated securely by pulling on it.
17 / 32

Instructions for use elements™ 8:1
5 Operation | 5.4 Removing the milling tool or diamond grinder
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5.4 Removing the milling tool or diamond grinder
WARNING
Hazard from rotating dental bur.
Lacerations and damage to the chuck system.
▶Do not touch the rotating dental bur!
▶Never push the push-button while the dental bur is rotating.
▶Remove the dental burs from the medical device after treatment to avoid
injury and infection during storage.
▶After the dental bur has stopped rotating, press the push-button down with
your thumb and simultaneously remove the dental bur.

Instructions for use elements™ 8:1
6 Checking for malfunctions and troubleshooting | 6.1 Check for malfunctions
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 use the product if it is irregularly heated.
NOTICE
Missing or damaged O-rings.
Malfunction and premature failure.
▶Make sure that all O-rings are on the coupling and are undamaged.
▶The medical device is too hot while idling:
Check the amount of cooling air.
▶The medical device is too hot while working:
Service the medical device.
▶When the speed drops or is uneven:
Service the medical device.
▶An O-ring is missing on the motor coupling:
Replace O-ring.
6.2 Troubleshooting
WARNING
Repair WITHOUT using KaVo original spare parts.
Parts such as the cover can come loose and cause injury.
Aspiration, swallowing of parts and 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 reas-
onable suspicion that the safety and health of patients or users may be jeop-
ardised, is prohibited by the German medical device law §4, section 1 no. 1
and requires a separate conformity check.
6.2.1 Replacing the 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.
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Instructions for use elements™ 8:1
6 Checking for malfunctions and troubleshooting | 6.2 Troubleshooting
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▶Push the O-ring to the front, and remove it.
▶Insert new O-rings into the grooves.