KERR ENDODONTICS elements 8:1 User manual

elements™ 8:1
Instructions for use
Instrucciones de uso
使用説明書

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: 077-0649
06/2021
Rev. A

Overview
Instructions for use........................................................................................................... 3
Instrucciones de uso ........................................................................................................ 91
使用説明書............................................................................................................................... 185
Instructions for use elements™ 8:1

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: 077-0649
06/2021
Rev. A

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
Contents 5 / 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
Contents 6 / 268

7.3 Automated reprocessing.............................................................................................64
7.3.1 Automated internal and external cleaning and internal and external disinfection... 67
7.3.2 Automated drying .......................................................................................... 67
7.4 Care products and systems - Servicing........................................................................69
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
7.5 Packaging.................................................................................................................79
7.6 Sterilisation...............................................................................................................80
7.7 Storage ....................................................................................................................83
8 Tools and consumables................................................................................................. 84
9 Terms and conditions of warranty................................................................................ 86
Contents 7 / 268

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.
1 User instructions 8 / 268

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: [email protected]
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
1 User instructions 9 / 268

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 direct-
ive.
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
1 User instructions 10 / 268

Information on the packaging
Follow instructions for use
Please note the instructions for use
Caution
Temperature range
Air pressure
1 User instructions 11 / 268

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!
1 User instructions 12 / 268

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 polycarbon-
ate (PC), polyamide (PA), styrene acrylonitrile (SAN),
polymethylmethacrylate (PMMA), polylactides (PLA), etc.
1 User instructions 13 / 268

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.
1 User instructions 14 / 268

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.
1 User instructions 15 / 268

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.
2 Safety 16 / 268

▶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 manufac-
turer.
▶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 instru-
ments.
▶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.
2 Safety 17 / 268

▶Check the technical condition before each use.
See also:
22.3 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.
2 Safety 18 / 268