Page 1
Instructions for use
Instrucciones de uso
使用説明書
elements™ 8:1
Page 2
Manufactured for:
Kerr Corporation
1717 West Collins Avenue
Orange CA 92867
U.S.
+1-800-KERR-123
www.kerrdental.com
Distributed by:
Kerr Australia Pty. Limited
Unit 6, 12 Mars Road
Lane Cove West, New South Wales 2066
Australia
+61-2-8870-3000
Manufacturer:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
www.kavo.com
PN: 077-0649
06/2021
Rev. A
Importer
Ormco B.V.
Basicweg 20 NL-3821 BR
Amersfoort, The Netherlands
Page 3
Instructions for use elements™ 8:1
Overview
Instructions for use...........................................................................................................
Instrucciones de uso........................................................................................................
使用説明書...............................................................................................................................
3
91
185
Page 4
Page 5
Instructions for use
elements™ 8:1
Page 6
Manufactured for:
Kerr Corporation
1717 West Collins Avenue
Orange CA 92867
U.S.
+1-800-KERR-123
www.kerrdental.com
Distributed by:
Kerr Australia Pty. Limited
Unit 6, 12 Mars Road
Lane Cove West, New South Wales 2066
Australia
+61-2-8870-3000
Manufacturer:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
www.kavo.com
PN: 077-0649
06/2021
Rev. A
Importer
Ormco B.V.
Basicweg 20 NL-3821 BR
Amersfoort, The Netherlands
Page 7
Contents
Table of contents
1 User instructions ............................................................................................................. 8
2 Safety............................................................................................................................. 16
2.1 Infection hazard ........................................................................................................16
2.2 Improper use............................................................................................................17
2.3 Technical condition ....................................................................................................19
2.4 Accessories and combination with other equipment ......................................................21
2.5 Qualification of personnel ...........................................................................................22
2.6 Service and repair .....................................................................................................23
3 Product description ....................................................................................................... 25
3.1 Purpose – Intended use ............................................................................................26
3.2 Technical Specifications..............................................................................................27
3.3 Symbols on product and rating plate...........................................................................29
3.4 Transportation and storage conditions .........................................................................32
4 Startup and shut down.................................................................................................. 34
5 Operation....................................................................................................................... 37
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Contents
6 / 268
5.1 Attaching the medical device ......................................................................................37
5.2 Removing the medical device .....................................................................................39
5.3 Inserting the dental bur or diamond grinder.................................................................40
5.4 Removing the milling tool or diamond grinder ..............................................................46
6 Checking for malfunctions and troubleshooting........................................................... 48
6.1 Check for malfunctions...............................................................................................48
6.2 Troubleshooting .......................................................................................................50
6.2.1
Replacing the O-rings on the motor coupling..................................................... 52
7 Reprocessing steps in accordance with ISO 17664...................................................... 53
7.1 Preparations at the site of use.....................................................................................53
7.2 Manual Reprocessing .................................................................................................55
7.2.1
Manual external cleaning.................................................................................56
7.2.2
Manual internal cleaning .................................................................................56
7.2.3
Manual external disinfection ............................................................................58
7.2.4
Manual internal disinfection ............................................................................. 61
7.2.5
Manual drying................................................................................................ 63
Page 9
Contents
7.3 Automated reprocessing.............................................................................................64
7.3.1
Automated internal and external cleaning and internal and external disinfection... 67
7.3.2
7.4 Care products and systems - Servicing........................................................................69
7.5 Packaging.................................................................................................................79
7.6 Sterilisation...............................................................................................................80
7.7 Storage ....................................................................................................................83
8 Tools and consumables................................................................................................. 84
9 Terms and conditions of warranty................................................................................ 86
Automated drying ..........................................................................................67
7.4.1
Servicing with KaVo Spray .............................................................................70
7.4.2
Servicing with KaVo QUATTROcare PLUS..........................................................71
7.4.3
Care with KaVo SPRAYrotor............................................................................. 75
7.4.4
Servicing with KaVo QUATTROcare .................................................................76
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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.
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1 User instructions
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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: KerrCustCare@kavokerr.com
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
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1 User instructions
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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
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1 User instructions
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Information on the packaging
Follow instructions for use
Please note the instructions for use
Caution
Temperature range
Air pressure
Page 14
1 User instructions
Relative Humidity
Rx
Caution: Federal (USA) law restricts device to sale by or
only
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!
12 / 268
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1 User instructions
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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.
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1 User instructions
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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 injury.
WARNING
In cases which – if not prevented – can lead to death or
severe injury.
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1 User instructions
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CAUTION
In cases which – if not prevented – can lead to minor or
moderate injury.
NOTICE
In cases which – if not prevented – can lead to material
damage.
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2 Safety
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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 carefully 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.
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2 Safety
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▶ Before initial startup and after each use, reprocess the
product and accessories appropriately.
▶ Carry out the reprocessing as described in the instructions
for use. The procedure has been validated by the manufacturer.
▶ If you deviate from this procedure, it is essential to make
sure that the reprocessing is effective.
▶ Reprocess the product and accessories appropriately before
disposal.
▶ If there is any injury to soft tissue, do not continue treat-
ment 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.
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2 Safety
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▶ Check the technical condition before each use.
See also:
2 2.3 Technical condition, Page 19
▶ 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 instru-
ment 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.
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2 Safety
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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.
▶ Check that the device is working properly and is in satisfact-
ory condition before each use.
▶ Have parts with sites of breakage or surface changes
checked by the Service.
▶ If the following defects occur, stop working and have the
service personnel carry out repair work:
▪ Malfunctions
▪ Damage
▪ Irregular running noise
▪ Excessive vibration
▪ Overheating
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2 Safety
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▪ 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 described in the instructions for use.
▶ The device should be reprocessed and stored in a dry loca-
tion, 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.
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2 Safety
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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 combina-
tion with the product by the manufacturer.
▶ Only use accessories that are equipped with standardised in-
terfaces.
▶ Do not make any modifications to the device unless these
have been approved 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.
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2 Safety
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▶ 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 in-
structions for use.
▶ Only employ the device if the user has the appropriate med-
ical training.
▶ Observe national and regional regulations.
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2 Safety
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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 ap-
propriate 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 sys-
tem 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 function check. Define the service interval depending on the frequency of use.
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2 Safety
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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 reasonable suspicion that the safety and health of patients or users may be jeopardised, is prohibited by the German
medical device law §4, section 1 no. 1 and requires a separate
conformity check.
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3 Product description
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3 Product description
elements™ 8:1, PN: 815-1655
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3 Product description
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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 reg-
ulations.
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
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3 Product description
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▪ 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.
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3 Product description
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The contra-angle handpiece can be mounted on all INTRAmatic
(LUX) motors and motors with a connector in accordance with
ISO 3964 / DIN 13940.
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3 Product description
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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
Consult instructions for use
Please note the electronic instructions for use
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3 Product description
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Certification
CE mark (Communauté Européenne)
Medical device, labelling of medical devices
Product characteristics
Manufacturer
Type Device type
SN Serial number
REF Material number
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3 Product description
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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
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3 Product description
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3.4 Transportation and storage conditions
NOTICE
Startup after refrigerated storage.
Malfunction.
▶ Prior to startup, strongly refrigerated products must be al-
lowed 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
Page 35
3 Product description
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Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture (Keep dry)
Page 36
4 Startup and shut down
34 / 268
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.
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4 Startup and shut down
35 / 268
See also:
2 7 Reprocessing steps in accordance with ISO 17664, Page
53
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 un-
contaminated according to EN ISO 7494-2.
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4 Startup and shut down
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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!
Page 39
5 Operation
37 / 268
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.
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5 Operation
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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 rotating.
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.
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5 Operation
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▶ 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 twist-
ing it slightly and then pulling it along its axis.
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5 Operation
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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
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5 Operation
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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.
Page 44
5 Operation
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WARNING
Hazard from rotating dental bur.
Lacerations.
▶ Do not touch the rotating dental bur!
▶ Remove the dental burs from the medical device after treat-
ment 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.
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5 Operation
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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.
Page 46
5 Operation
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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 recom-
mended by the manufacturer.
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5 Operation
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NOTICE
Dental bur with worn or damaged shafts.
Material damage to the chuck system, dental bur is difficult or
impossible to remove 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.
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5 Operation
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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 treat-
ment to avoid injury and infection during storage.
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5 Operation
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▶ After the dental bur has stopped rotating, press the push-
button down with your thumb and simultaneously remove
the dental bur.
Page 50
6 Checking for malfunctions and troubleshooting
6 Checking for malfunctions and
troubleshooting
6.1 Check for malfunctions
Product heats up.
Burn injury or product damage due to over-heating.
▶ Do not use the product if it is irregularly heated.
48 / 268
CAUTION
Page 51
6 Checking for malfunctions and troubleshooting
Missing or damaged O-rings.
Malfunction and premature failure.
▶ Make sure that all O-rings are on the coupling and are un-
damaged.
▶ 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.
49 / 268
NOTICE
Page 52
6 Checking for malfunctions and troubleshooting
6.2 Troubleshooting
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 re-
pair; original KaVo spare parts comply with the specification.
50 / 268
WARNING
Page 53
6 Checking for malfunctions and troubleshooting
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 reasonable suspicion that the safety and health of patients or users may be jeopardised, is prohibited by the German
medical device law §4, section 1 no. 1 and requires a separate
conformity check.
51 / 268
Page 54
6 Checking for malfunctions and troubleshooting
6.2.1 Replacing the O-rings on the motor
coupling
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.
▶ Push the O-ring to the front, and remove it.
▶ Insert new O-rings into the grooves.
52 / 268
NOTICE
Page 55
7 Reprocessing steps in accordance with ISO 17664
7 Reprocessing steps in accordance with ISO
17664
7.1 Preparations at the site of use
Hazard from contaminated products.
Contaminated products are associated with an infection hazard.
▶ Take suitable personal protective measures.
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶ Remove the tool.
53 / 268
WARNING
WARNING
Page 56
7 Reprocessing steps in accordance with ISO 17664
▶ Reprocess the medical device as soon as possible after
treatment.
▶ The medical device must be dry when transported to repro-
cessing.
▶ To minimise the risk of infection during reprocessing, always
wear protective gloves.
▶ Remove the tool from the medical device.
▶ Remove all residual cement, composite or blood immedi-
ately.
▶ Do not place in solutions or similar substances.
54 / 268
Page 57
7 Reprocessing steps in accordance with ISO 17664
7.2 Manual Reprocessing
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶ Remove the tool.
Never reprocess this medical device in an ultrasonic
cleaner.
Malfunction and material damage.
▶ Clean manually or in a washer disinfector only.
55 / 268
WARNING
NOTICE
Page 58
7 Reprocessing steps in accordance with ISO 17664
7.2.1 Manual external cleaning
Accessories required:
▪ Tap water 30 oC ± 5 oC (86 oF ± 10 oF)
▪ Brush, e.g. medium-hard toothbrush
▶ Brush off under flowing tap water.
7.2.2 Manual internal cleaning
Validated internal cleaning (removal of residual protein) can be
accomplished with KaVo CLEANspray.
▶ Cover the medical device with the KaVo Cleanpac bag, and
place it on the corresponding care adapter.
56 / 268
Page 59
7 Reprocessing steps in accordance with ISO 17664
▶ Hold the can vertically.
▶ Press the spray button three times for 2 seconds each time.
▶ Remove the medical device from the spray attachment and
let the cleanser act for 1 minute.
See also:
2 KaVo CLEANspray Instructions for Use
▶ If a manual external and internal disinfection do not follow
directly, dry the medical device with KaVo DRYspray.
See also:
2 7.2.5 Drying, Page 63
57 / 268
Page 60
7 Reprocessing steps in accordance with ISO 17664
7.2.3 Manual external disinfection
Incomplete disinfection.
Infection hazard.
▶ Only use disinfection procedures that are verified to be bac-
tericidal, fungicidal 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 steam steriliser.
58 / 268
WARNING
Page 61
7 Reprocessing steps in accordance with ISO 17664
Never disinfect the medical device with chloride-containing products.
Malfunction and material damage.
▶ Only disinfect in a washer disinfector or manually.
KaVo 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 (intermediate disin-
fection)
▪ Mikrozid AF made by Schülke & Mayr (liquid or cloths)
▪ FD 322 made by Dürr
59 / 268
NOTICE
Page 62
7 Reprocessing steps in accordance with ISO 17664
Consumables required:
Cloths for wiping the medical device.
▶ Spray the disinfectant on a cloth, then wipe down the med-
ical device and allow the disinfectant to act according to the
instructions of the disinfectant manufacturer.
▶ Follow the instructions for use of the disinfectant.
60 / 268
Page 63
7 Reprocessing steps in accordance with ISO 17664
7.2.4 Manual internal disinfection
Incomplete disinfection.
Infection hazard.
▶ Only use disinfection procedures that are verified to be bac-
tericidal, fungicidal 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 steam steriliser.
61 / 268
WARNING
Page 64
7 Reprocessing steps in accordance with ISO 17664
Never disinfect the medical device with chloride-containing products.
Malfunction and material damage.
▶ Only disinfect in a washer disinfector or manually.
The efficacy of manual internal disinfection must be demonstrated by the manufacturer of the disinfection agent. With KaVo
products, use only disinfection agents that have been released by
KaVo with respect to the compatibility of materials (e.g. WL-cid /
made by ALPRO).
▶ Cover the medical device with the KaVo CLEANpac bag, and
place it on the corresponding care adapter.
▶ Hold the can vertically.
62 / 268
NOTICE
Page 65
7 Reprocessing steps in accordance with ISO 17664
▶ Press the spray key for at least 3 seconds.
▶ Remove the medical device from the spray attachment and
let the disinfectant act for 2 minutes.
▶ Follow the instructions for use of the disinfectant.
7.2.5 Manual drying
Use KaVo DRYspray for subsequent drying of the air, water and
gear unit ducts.
▶ Cover the medical device with the KaVo CLEANpac bag, and
place it on the corresponding care adapter.
▶ Hold the can vertically.
▶ Press the spray key for at least 3 seconds.
See also:
2 KaVo DRYspray Instructions for Use
63 / 268
Page 66
7 Reprocessing steps in accordance with ISO 17664
▶ Immediately after drying, lubricate the KaVo medical device
with care agents from the KaVo care system.
See also:
2 7.4 Care products and systems - Servicing, Page 69
7.3 Automated reprocessing
Incomplete disinfection.
Infection hazard.
▶ Only use disinfection procedures that are verified to be bac-
tericidal, fungicidal 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 steam steriliser.
64 / 268
WARNING
Page 67
7 Reprocessing steps in accordance with ISO 17664
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶ Remove the tool.
Never disinfect the medical device with chloride-containing products.
Malfunction and material damage.
▶ Only disinfect in a washer disinfector or manually.
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WARNING
NOTICE
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7 Reprocessing steps in accordance with ISO 17664
Never reprocess this medical device in an ultrasonic
cleaner.
Malfunction and material damage.
▶ Clean manually or in a washer disinfector only.
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NOTICE
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7 Reprocessing steps in accordance with ISO 17664
7.3.1 Automated internal and external cleaning
and internal and external disinfection
KaVo recommends washer disinfectors according to EN ISO
15883-1, which are operated using alkaline cleaning agents having a maximum pH value of 10.
The validation was performed in a Miele washer disinfector using
the "VARIO-TD" program, the "neodisher mediclean" cleaning
agent, the "neodisher Z" neutralizer, and the "neodisher mielclear" rinsing agent.
▶ For programme settings as well as cleansers and disinfect-
ants to be used, please refer to the Instructions for Use of
the thermodisinfector.
7.3.2 Automated drying
The drying procedure is normally part of the cleaning programme
of the washer disinfector.
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7 Reprocessing steps in accordance with ISO 17664
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.
▶ Remove any residual liquids with KaVo DRYspray.
See also:
2 7.2.5 Manual drying, Page 63
▶ Immediately after drying, lubricate the KaVo medical device
with care agents from the KaVo care system.
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7 Reprocessing steps in accordance with ISO 17664
7.4 Care products and systems - Servicing
Sharp tool in the medical device.
Injury hazard from sharp and/or pointed tool.
▶ Remove the tool.
Improper service and care.
Risk of injury.
▶ Service regularly with suitable agents.
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WARNING
CAUTION
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7 Reprocessing steps in accordance with ISO 17664
Note
KaVo guarantees the proper function of KaVo products only if the
care products listed as accessories are used, since these were
tested for proper use on our products.
7.4.1 Servicing with KaVo Spray
KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and
before each sterilisation, but no later than after 30 minutes of
operation and generally after every 6th patient.
▶ Remove the tool from the medical device.
▶ Cover the medical device with the KaVo CLEANpac bag, and
place it on the corresponding care adapter.
▶ Press the spray key for 1 to 2 seconds.
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7 Reprocessing steps in accordance with ISO 17664
Servicing the chucking system
KaVo recommends servicing the chucking system once weekly.
▶ Remove the tool from the medical device.
▶ Position the tip of the spray nipple in the opening, and apply
the spray.
▶ Press the spray key for 1 to 2 seconds.
7.4.2 Servicing with KaVo QUATTROcare PLUS
Servicing and cleaning device with expansion pressure for the interior cleaning of inorganic residues and optimum care.
(no validated cleaning of the interior in accordance with German
RKI requirements)
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7 Reprocessing steps in accordance with ISO 17664
KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and
before each sterilisation, but no later than after 30 minutes of
operation and generally after every 6th patient.
▶ Remove the tool from the medical device.
▶ Service the product in the QUATTROcare PLUS.
See also:
2 Instructions for use KaVo QUATTROcare PLUS
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7 Reprocessing steps in accordance with ISO 17664
Servicing the chuck
KaVo recommends servicing the chuck system once a week using
the chuck servicing program integrated in the device.
Note
Handpieces must be taken off the service couplings before the
chuck service can be started and performed.
▶ Close the front door and press the chuck service button for
at least three seconds until the spray canister control LED
flashes three times consecutively.
ð The device is in chuck service mode.
▶ Remove the service coupling of the chuck from the side
hatch of the QUATTROcare PLUS and attach it to coupling
service point four, on the far right. A MULTIflex adaptor
must be mounted there.
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7 Reprocessing steps in accordance with ISO 17664
▶ Press the handpiece together with the guide bush of the
chuck to be serviced against the tip of the service coupling.
▶ Press the button marked with the chuck service symbol.
Note
Close the chuck service mode.
Option 1: Place the dental handpieces in the QUATTROcare PLUS
2124 A, close the front door and start theservice procedure.
Option 2: After three minutes with no service procedure running,
the device automatically switches back to normal service mode.
See also:
2 Servicing with KaVo QUATTROcare PLUS
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7 Reprocessing steps in accordance with ISO 17664
7.4.3 Care with KaVo SPRAYrotor
Note
KaVo SPRAYrotor is no longer included in the current de-
livery programme.
Follow-up product:
▶ QUATTROcare PLUS 2124 A
KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and
before each sterilisation, but no later than after 30 minutes of
operation and generally after every 6th patient.
▶ Cover the medical device with the Cleanpac bag, and place it
on the corresponding servicing adapter on the KaVo
SPRAYrotor.
▶ Service the product.
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7 Reprocessing steps in accordance with ISO 17664
See also:
2 Instructions for use KaVo SPRAYrotor
7.4.4 Servicing with KaVo QUATTROcare
Note
QUATTROcare 2104 / 2104 A is no longer included in the
current delivery programme.
Follow-up product:
▶ QUATTROcare PLUS 2124 A
Servicing and cleaning device with expansion pressure for the interior cleaning of inorganic residues and optimum care.
(no validated cleaning of the interior in accordance with German
RKI requirements)
KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and
before each sterilisation.
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7 Reprocessing steps in accordance with ISO 17664
▶ Remove the tool from the medical device.
▶ Service the product in the QUATTROcare.
See also:
2 Instructions for use KaVo QUATTROcare 2104 / 2104A /
2124A
Servicing the chuck
KaVo recommends servicing the chucking system once weekly.
▶ Remove the tool from the medical device.
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7 Reprocessing steps in accordance with ISO 17664
▶ Plug the spray nipple of the chuck servicing set onto the
QUATTROcare plus Spray.
▶ Position the tip of the spray nipple in the opening, and apply
the spray.
▶ Press the spray key for 1 to 2 seconds.
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7 Reprocessing steps in accordance with ISO 17664
7.5 Packaging
Note
The sterile goods package must be large enough for the product
so that the packaging is not stretched.
The quality and use of the packaging of the items to be sterilised
must satisfy the applicable standards and be appropriate for the
sterilisation process!
▶ The medical device must be packed before sterilisation.
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7 Reprocessing steps in accordance with ISO 17664
7.6 Sterilisation
Sterilisation in a steam steriliser (autoclave) in
accordance with EN 13060 / EN ISO 17665-1
Improper service and care.
Risk of injury.
▶ Service regularly with suitable agents.
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CAUTION
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7 Reprocessing steps in accordance with ISO 17664
Contact corrosion due to moisture.
Damage to product.
▶ Immediately remove the product from the steam steriliser
after the sterilisation cycle.
The KaVo medical device has a maximum temperature resistance up to 138 ℃ (280.4 °F).
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NOTICE
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7 Reprocessing steps in accordance with ISO 17664
Sterilisation parameters:
Select a suitable process from the following sterilisation processes (depending on the available steriliser):
▪ Steriliser with triple pre-vacuum:
- at least 3 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6
°F / +7.4 °F)
▪ Steriliser using the gravity method:
- at least 10 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6
°F / +7.4 °F)
- at least 60 minutes at 121 °C -1 °C / +4 °C (250 °F -1.6
°F / +7.4 °F)
▶ Remove the medical device immediately after the comple-
tion of the sterilisation cycle from the steriliser.
▶ Use according to the manufacturer's Instructions for Use.
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7 Reprocessing steps in accordance with ISO 17664
7.7 Storage
Prepared products must be stored appropriately in a dry, dark,
cool room such that they are protected from germs (as far as
possible) and dust.
Note
Comply with the expiry date of the sterilised items.
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Page 86
8 Tools and consumables
8 Tools and consumables
Available from dental suppliers.
Availability may vary depending on region.
Material summary Mat. No.
INTRA instrument stand 3.005.5204
Cleanpac 10 units 0.411.9691
Cellulose pad 100 units 0.411.9862
Spray head INTRA (KaVo
Spray)
Service coupling INTRA
(QUATTROcare)
0.411.9911
1.009.6143
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Page 87
8 Tools and consumables
Material summary Mat. no.
Adaptor INTRAmatic
(CLEANspray and DRYspray)
KaVo CLEANspray 2110 P 1.007.0579
KaVo DRYspray 2117 P 1.007.0580
KaVo Spray 2112 A 0.411.9640
ROTAspray 2 2142 A 0.411.7520
QUATTROcare plus Spray 2140P1.005.4525
Chuck servicing set 1.003.1253
1.007.1776
85 / 268
Page 88
9 Terms and conditions of warranty
9 Terms and conditions of warranty
The following warranty conditions apply to this KaVo medical
device:
KaVo provides the end customer with a warranty of proper function and guarantees zero defects in respect of material and workmanship for a period of 12 months from the date of the invoice,
subject to the following conditions:
In case of justified complaints, KaVo will honour its warranty with
a free replacement or repair. Other claims of any kind whatsoever, in particular with respect to compensation, are excluded. In
the event of default, gross negligence or intent, this shall only
apply in the absence of mandatory legal regulations to the contrary.
KaVo shall not be liable for defects and their consequences that
have arisen or may arise from natural wear, improper handling,
cleaning or maintenance, non-compliance with operating, main-
86 / 268
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9 Terms and conditions of warranty
tenance or connection instructions, calcination or corrosion, contaminated air or water supplies or chemical or electrical factors
deemed abnormal or impermissible in accordance with KaVo's instructions for use or other manufacturer's instructions. The warranty granted does not usually extend to lamps, optical fibres
made of glass and glass fibres, glassware, rubber parts, and the
colourfastness of plastic parts.
All liability is excluded if defects or their consequences originate
from manipulations or changes to the product made by the customer or a third party that is not authorised by KaVo.
Warranty claims will only be accepted if the product is submitted
along with proof of purchase in the form of a copy of the invoice
or note of delivery. The dealer, purchase date, type, and serial
number must be clearly evident from this document.
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9 Terms and conditions of warranty
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Page 91
Instrucciones de uso
elements™ 8:1
Page 92
Fabricado para:
Kerr Corporation
1717 West Collins Avenue
Orange CA 92867
EE.UU.
+1-800-KERR-123
www.kerrdental.com
Distribución:
Kerr Australia Pty. Limited
Unit 6, 12 Mars Road
Lane Cove West, New South Wales 2066
Australia
+61-2-8870-3000
Fabricante:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Alemania
www.kavo.com
PN: 077-0649
06/2021
Rev. A
Importador:
Ormco B.V.
Basicweg 20 NL-3821 BR
Amersfoort, The Netherlands
Page 93
Índice
Tabla de contenidos
1 Informaciones para el usuario...................................................................................... 96
2 Seguridad .................................................................................................................... 105
2.1 Riesgo de infección..................................................................................................105
2.2 Uso incorrecto.........................................................................................................107
2.3 Estado técnico.........................................................................................................108
2.4 Accesorios y combinaciones con otros aparatos..........................................................110
2.5 Cualificación del personal .........................................................................................111
2.6 Servicio y reparación ..............................................................................................112
3 Descripción del producto............................................................................................. 115
3.1 Fin previsto - Uso conforme a las disposiciones ..........................................................116
3.2 Datos técnicos.........................................................................................................118
3.3 Símbolos en el producto y en la placa de características..............................................119
3.4 Condiciones de transporte y almacenamiento.............................................................122
4 Puesta en servicio y puesta fuera de servicio ............................................................ 124
5 Manejo......................................................................................................................... 127
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Índice
94 / 268
5.1 Colocar el producto sanitario.....................................................................................127
5.2 Extracción del producto sanitario...............................................................................129
5.3 Colocar la herramienta de fresado o la lima de diamante.............................................130
5.4 Extracción de la herramienta de fresado o de la lima de diamante................................137
6 Comprobación y resolución de problemas.................................................................. 139
6.1 Comprobación de averías.........................................................................................139
6.2 Solución de averías .................................................................................................141
6.2.1
Sustituir la junta tórica del acoplamiento del motor.......................................... 143
7 Pasos de preparación según la norma ISO17664...................................................... 145
7.1 Preparativos............................................................................................................145
7.2 Preparación manual.................................................................................................147
7.2.1
Limpieza exterior manual.............................................................................. 148
7.2.2
Limpieza interior manual............................................................................... 148
7.2.3
Desinfección exterior manual......................................................................... 150
7.2.4
Desinfección interior manual ......................................................................... 153
7.2.5
Secado manual ............................................................................................ 155
Page 95
Índice
7.3 Reacondicionamiento a máquina...............................................................................157
7.3.1
Limpieza interna y externa y desinfección interna y externa mecánicas ............. 160
7.3.2
7.4 Productos y sistemas de conservación - Servicio.........................................................162
7.5 Embalaje................................................................................................................173
7.6 Esterilización...........................................................................................................174
7.7 Almacenamiento .....................................................................................................177
8 Medios auxiliares......................................................................................................... 178
9 Condiciones de la garantía.......................................................................................... 180
Secado mecánico......................................................................................... 160
7.4.1
Mantenimiento con KaVo Spray .................................................................... 163
7.4.2
Mantenimiento con KaVo QUATTROcare PLUS................................................. 165
7.4.3
Mantenimiento con KaVo SPRAYrotor............................................................. 169
7.4.4
Mantenimiento con KaVo QUATTROcare ........................................................ 170
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Page 96
1 Informaciones para el usuario
1 Informaciones para el usuario
Estimado usuario,
Felicitaciones por la compra de este producto Kerr Endodontics.
Para poder trabajar sin problemas y de forma rentable y segura,
lea atentamente las indicaciones siguientes.
KaVo y elements8:1 son marcas registradas o marcas de KaVo
Dental GmbH.
Todas las demás marcas son propiedad de su respectivo propie-
tario.
96 / 268
Page 97
1 Informaciones para el usuario
Servicio al cliente de Kerr
En caso de reparaciones, diríjase a su comerciante o directamente al servicio de reparaciones de Kerr:
Gratuito: +1-800-KERR-123
Página web: www.kerrdental.com
Correo electrónico: KerrCustCare@kavokerr.com
Grupo de destino
Este documento va dirigido a dentistas y al
personal del consultorio.
El capítulo de puesta en servicio se dirige, además, al personal de
mantenimiento.
97 / 268
Page 98
1 Informaciones para el usuario
Señales y símbolos generales
98 / 268
Véase el capítulo de informaciones para el usuario/niveles
de peligro
Información importante para usuarios y técnicos
Requerimiento de actuación
Marcado CE (Comunidad Europea). Todo producto que lleva este símbolo cumple los requisitos de la directiva CE
aplicable.
Dispositivo médico, etiquetado de productos sanitarios
Page 99
1 Informaciones para el usuario
Indicaciones en el embalaje:
99 / 268
Esterilizable con vapor 134 oC -1 oC / +4 oC (273 oF -1,6
o
F / +7,4 oF)
Termodesinfectable
Respetar las instrucciones de uso
Tener en cuenta las instrucciones de uso
Cuidado
Page 100
1 Informaciones para el usuario
Rx
only
100 / 268
Rango de temperaturas
Presión de aire
Humedad relativa del aire
Precaución: La ley federal (EE.UU.) restringe el producto a
la venta por parte de un odontólogo o por encargo de
uno.
Distintivo CE (distintivo de la Comunidad Europea)
Dispositivo médico, etiquetado de productos sanitarios
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