KaVo Poly One User manual

Instructions for use
KaVo polymerisation light Poly One

Distributed by:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
Phone [phone]
Fax [phone]
Manufacturer:
Kaltenbach & Voigt GmbH
Bismarckring 39
88400 Biberach
Germany
www.kavo.com

Table of contents
1 User instructions ................................................................................................................ 4
1.1 User guide .................................................................................................................... 4
1.1.1 Abbreviations..................................................................................................... 4
1.1.2 Symbols............................................................................................................ 4
1.1.3 Target group ..................................................................................................... 4
1.2 Service......................................................................................................................... 4
1.3 Terms and conditions of warranty.................................................................................... 5
1.4 Transportation and storage............................................................................................. 5
1.4.1 Currently valid packaging regulations ................................................................... 5
1.4.2 Damage in transit .............................................................................................. 5
1.4.3 Information on the packaging: Storage and transportation ..................................... 6
2 Safety.................................................................................................................................. 8
2.1 Description of safety instructions..................................................................................... 8
2.1.1 Warning symbol................................................................................................. 8
2.1.2 Structure........................................................................................................... 8
2.1.3 Description of hazard levels................................................................................. 8
2.2 Purpose – Proper use ..................................................................................................... 8
2.2.1 General information............................................................................................ 8
2.2.2 Product-specific.................................................................................................. 9
2.3 Safety instructions......................................................................................................... 10
2.3.1 General information............................................................................................ 10
2.3.2 Product-specific.................................................................................................. 11
3 Description of the Product..................................................................................................13
3.1 Technical Specifications.................................................................................................. 14
4 Commissioning ................................................................................................................... 16
5 Operation............................................................................................................................ 17
6 Reprocessing methods according to ISO 17664 ................................................................19
6.1 Cleaning ....................................................................................................................... 19
6.1.1 Manual cleaning ................................................................................................. 19
6.1.2 Automated cleaning............................................................................................ 20
6.2 Disinfection................................................................................................................... 20
6.2.1 Manual disinfection............................................................................................. 20
6.2.2 Automated disinfection ....................................................................................... 20
6.3 Drying.......................................................................................................................... 20
6.3.1 Manual drying.................................................................................................... 20
6.3.2 Automatic Drying ............................................................................................... 21
6.4 Sterilisation................................................................................................................... 21
6.5 Storage ........................................................................................................................ 21
7 Troubleshooting ................................................................................................................. 22
8 Accessories and spare parts............................................................................................... 23
Instructions for use KaVo polymerisation light Poly One
Table of contents
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Instructions for use KaVo polymerisation light Poly One
1 User instructions | 1.1 User guide
4 / 26
1 User instructions
1.1 User guide
Requirement
Read these instructions prior to first startup to avoid misuse and prevent dam-
age.
1.1.1 Abbreviations
Ab-
brevi-
ation
Explanation
IFU Instructions for use
CI Care instructions
SIFU Short instructions for use
AI Assembly instructions
TI Technician's instructions
IEC International Electrotechnical Commission
RI Repair instructions
RK Retrofitting kit
AS Assembly kit
CK Conversion kit
EP Enclosed parts
EMC Electromagnetic compatibility
PI Processing instructions
1.1.2 Symbols
Important information for users and technicians
Action request
Warning symbol
1.1.3 Target group
This document is for dentists and dental office staff.
1.2 Service
KaVo Customer Service:
[phone]
[e-mail] or [e-mail]
Please refer to the serial number of the product in all inquiries!
For further information, please visit: www.kavo.com

Instructions for use KaVo polymerisation light Poly One
1 User instructions | 1.3 Terms and conditions of warranty
1.3 Terms and conditions of warranty
KaVo provides the final customer with a warranty that the product cited in the
handover certificate will function properly and guarantees zero defects in the
material or processing for a period of 12 months from data of purchase, subject
to the following conditions:
Upon justified complaints of flaws or a short delivery, KaVo will make good its
warranty by replacing the product free of cost or repairing it according to the
customer's wishes. Other claims of any nature whatsoever, in particular with
respect to compensation, are excluded. In the event of default and gross negli-
gence or intent, this shall only apply in the absence of mandatory legal regula-
tions to the contrary.
KaVo cannot be held liable for defects and their consequences due to natural
wear, improper cleaning or servicing, non-compliance with operating, servicing
or connection instructions, calcification or corrosion, contaminated air or water
supplies or chemical or electrical factors deemed abnormal or impermissible in
accordance with factory specifications.
The warranty does not usually cover bulbs, glassware, rubber parts and the col-
ourfastness of plastics.
Defects or their consequences that can be attributed to interventions on or
changes made to the product by the customer or a third party are excluded
from the warranty.
Claims from this warranty can only be asserted when the transfer form (copy)
belonging to the product has been sent to KaVo, and the original can be
presented by the operator or user.
1.4 Transportation and storage
1.4.1 Currently valid packaging regulations
Note
Only valid for the Federal Republic of Germany.
Dispose of and recycle the sales packaging appropriately in accordance with
current packaging regulations, employing waste management or recycling com-
panies. Comply with the comprehensive return system. KaVo has had its sales
packaging licensed for this purpose. Please comply with the regional public
waste-disposal system.
1.4.2 Damage in transit
In Germany
If the packaging is visibly damaged on delivery, please proceed as follows:
1. The recipient of the package must record the loss or damage on the delivery
receipt. The recipient and the representative of the shipping company must
sign this delivery receipt.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use the product.
4. Report the damage to the shipping company.
5. Report the damage to KaVo.
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Instructions for use KaVo polymerisation light Poly One
1 User instructions | 1.4 Transportation and storage
6 / 26
6. Consult with KaVo first, before returning a damaged product.
7. Send the signed delivery receipt to KaVo.
If the product is damaged but there was no discernable damage to the pack-
aging on delivery, proceed as follows:
1. Report the damage to the shipping company immediately and no later than
7 days after delivery.
2. Report the damage to KaVo.
3. Leave the product and packaging in the condition in which you received it.
4. Do not use a damaged product.
Note
Failure on the part of the recipient to comply with any of the above-men-
tioned obligations will mean that the damage will be considered to have
arisen following delivery (in accordance with the General German Freight For-
warders' Terms and Conditions, Art. 28).
Outside Germany
Note
KaVo shall not be held liable for damage arising from transportation.
The shipment must be checked on arrival.
If the packaging is visibly damaged on delivery, please proceed as follows:
1. The recipient of the package must record the loss or damage on the delivery
receipt. The recipient and the representative of the shipping company must
sign this delivery receipt.
Without this evidence, the recipient will not be able to assert a claim for
damages against the shipping company.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use the product.
If the product is damaged but there was no discernable damage to the pack-
aging on delivery, proceed as follows:
1. Report any damage to the shipping company immediately and no later than
7 days after delivery.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use a damaged product.
Note
If the recipient fails to comply with any of the above-mentioned obligations,
the damage will be considered to have arisen following delivery
(in accordance with CMR law, Chapter 5, Art. 30).
1.4.3 Information on the packaging: Storage and
transportation
Note
Please keep the packaging in case you need to return the product for servi-
cing or repair.
The symbols printed on the outside are for transportation and storage, and
have the following meaning:

Instructions for use KaVo polymerisation light Poly One
1 User instructions | 1.4 Transportation and storage
Transport upright with the arrows pointing upwards!
Fragile - protect against impact!
Protect from moisture!
Permissible stacking load
Temperature range
Humidity
Air pressure
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Instructions for use KaVo polymerisation light Poly One
2 Safety | 2.1 Description of safety instructions
8 / 26
2 Safety
2.1 Description of safety instructions
2.1.1 Warning symbol
Warning symbol
2.1.2 Structure
DANGER
The introduction describes the type and source of the hazard.
This section describes potential consequences of non-compliance.
▶The optional step includes necessary measures for hazard prevention.
2.1.3 Description of 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.
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.
2.2 Purpose – Proper use
2.2.1 General information
This KaVo product is intended for use in dentistry only. Any other type of use is
not permitted.
"Proper use" includes compliance with all instructions for use and the inspection
and maintenance intervals.
The overarching guidelines and/or national laws, national regulations and the
rules of technology applicable to medical devices for start-up and use of the
KaVo product for the intended purpose must be applied and followed.

Instructions for use KaVo polymerisation light Poly One
2 Safety | 2.2 Purpose – Proper use
The applicable national legal regulations must be observed during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and startup of medical
devices.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
It is a responsibility of the user:
▪ to only use equipment that is operating correctly,
▪ to protect him or herself, the patient and third parties from hazards, and
▪ to prevent contamination from the product
2.2.2 Product-specific
The curing light Poly One is designed for the curing of dental materials in the
oral cavity of a patient in the course of a dental treatment. For installation on
dental treatment centres; the use is restricted to medical specialist staff in
rooms used for medical purposes.
The user must ensure that the device works safely and is in a satisfactory con-
dition before each use.
Information on electromagnetic compatibility
Note
Based on IEC 60601-1-2 (DIN EN 60601-1-2) concerning the electromag-
netic compatibility of electrical medical devices, we must draw your attention
to the following points:
• Electrical medical devices are subject to special precautionary measures re-
garding electromagnetic compatibility and must be operated in accordance
with the KaVo installation instructions.
• High-frequency communications devices can affect the operation of elec-
trical medical devices.
Further details of the technical EMC description are available on request.
See also:
2For "Specific details concerning electromagnetic compatibility in accordance
with EN 60601-1-2", see the instructions for use of the respective treatment
centre
Note
KaVo cannot guarantee the compliance of accessories, cables, and other
components not supplied by KaVo with the EMC requirements of IEC
60601-1-2 (DIN EN 60601-1-2).
Disposal
Note
Any waste which is generated must be recycled or disposed of in strict com-
pliance with all applicable national regulations in a manner which is safe both
for people and the environment.
If you have any questions regarding proper disposal of the KaVo product,
please contact the KaVo branch.
9 / 26

Instructions for use KaVo polymerisation light Poly One
2 Safety | 2.3 Safety instructions
10 / 26
Disposal of electronic and electrical devices
Note
According to the general WEEE Directive (Waste Electrical and Electronic
Equipment) and EU Directive 2012/19 concerning waste electrical and elec-
tronic equipment, we wish to point out that this product is subject to the
aforementioned Directive and must be subjected to special disposal within
Europe.
For more information, please visit www.kavo.com or contact your specialised
dental dealers.
For final disposal:
In Germany
To return an electrical device, you need to proceed as follows:
1. On the homepage www.enretec.de of enretec GmbH, you can download a
form for a disposal order under the menu item, eom. Download the disposal
order or complete it as an online order.
2. Enter the corresponding information to complete the order, and submit it as
an online order or by fax [phone] to enretec GmbH.
The following contact options are also available for questions and for initiat-
ing a disposal order:
Phone: [phone]
Email: [e-mail] and
Postal address: enretec GmbH, Geschäftsbereich eomRECYCLING®
Kanalstraße 17
D-16727 Velten
3. A unit that is not permanently installed will be picked up at the office.
A permanently installed unit will be picked up at the curb at your address on
the agreed date.
The owner or user of the device will have to bear the cost of disassembly,
transportation and packaging.
International
For country-specific information on disposal, contact your specialised dealers.
2.3 Safety instructions
2.3.1 General information
DANGER
Explosion hazard.
Risk of fatal injury.
▶Do not use KaVo product in areas subject an explosion hazard.

Instructions for use KaVo polymerisation light Poly One
2 Safety | 2.3 Safety instructions
WARNING
Application of un-authorised accessories or un-authorised modifica-
tions of the product.
Accessories that have not been approved and/or inadmissible modifications of
the product could lead to hazards and/or personal injury or property damage.
▶Only use accessories that have been approved for combination with the
product by the manufacturer or are equipped with standardised interfaces
(e. g. MULTIflex couplings, INTRAmatic).
▶Do not make any modifications to the device unless these have been ap-
proved by the manufacturer of the product.
NOTICE
Premature wear and malfunctions from improper servicing and care.
Reduced product life.
▶Perform regular proper care and servicing!
The following persons are authorised to conduct repairs and servicing and the
safety check on the KaVo product:
▪ Technicians of KaVo branch offices after appropriate product training.
▪ Specifically KaVo-trained technicians of KaVo franchised dealers.
Decommissioning
WARNING
Dispose of the product in appropriate manner.
Infection hazard.
▶Before disposal, reprocess and sterilise the product and accessories appro-
priately.
2.3.2 Product-specific
Warning
Danger from optical radiation.
Eyes can be blinded or damaged by LED of risk group 2 in accordance with
IEC 62471 (blue light).
▶Do not gaze directly into the light exit aperture of the fibre-optic cable or
into the lamp.
CAUTION
Inappropriate processing of filling material.
Hazard to the patient from the curing time of the filling material being too short
or too long.
▶Please comply with the manufacturer's instructions as regards the pro-
cessing and curing time of the filling material.
NOTICE
Product damage from kinking or pinching the handpiece hose.
Irreversible breakage of the lines in the handpiece hose.
▶Do not pull in the handpiece hose!
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Instructions for use KaVo polymerisation light Poly One
2 Safety | 2.3 Safety instructions
12 / 26
NOTICE
Product damage from improper cleaning.
The handpiece surface, light exit aperture or light inlet aperture may become
damaged.
▶Do not use abrasives or aggressive cleansers!
▶Do not immerse the handpiece in liquids!
NOTICE
Damage from improper use.
Damage to the curing light.
▶Always place the handpiece in the holder with the fibre-optic cable/glass
rod attached to it.
CAUTION
Damage from heating
The temperature of the glass rod at its end (light exit surface) may be up to
55°C.
▶Prevent direct contact with the skin. The lack of heat energy tracking is not
associated with a risk of burn injury, but possible contact with the mucosa
may be experienced as unpleasant.
▶Proper Use requires no direct contact and direct contact can be prevented
through careful handling by the user.

Instructions for use KaVo polymerisation light Poly One
3 Description of the Product | 2.3 Safety instructions
3 Description of the Product
3
2
1
6
4
7
5
SN YYYY-MM-XXXX
0
1
2
4
8
10
11
13
12
9
9
Curing light Poly One (Mat. no. 3.000.3800)
①Fibre-optic cable (Mat. no.
30003812)
②Protective shield (Mat. no.
30003811)
③Button "Select curing time" and/or
"On/Off"
④Manufacturer
⑤Made in Germany ⑥SN YYYY-MM-XXXX
⑦Handpiece hose (1,600 mm for as-
sistant element)
⑧Connector on the unit
⑨Reference number/product name ⑩Type B application part
⑪Comply with the safety-related in-
formation in the instructions for use
⑫Optical radiation warning in accord-
ance with DIN 4844-2
⑬CE mark according to 93/42/EEC
medical devices
The curing light Poly One emits visible blue light of a wavelength between 450
to 460 nm for photopolymerisation of dental materials.
13 / 26

Instructions for use KaVo polymerisation light Poly One
3 Description of the Product | 3.1 Technical Specifications
14 / 26
3.1 Technical Specifications
Light source LED
Sterilisable parts Fibre-optic cable made of glass
Wavelengths 450 - 460 nm
Peak wavelength 457 nm
Curing times 3 curing times: 20, 40 or 60 seconds
Minimum radiation power 800 mW/cm2
The radiation power was determined
with a spectroradiometer.
Weight of handpiece and fibre-optic
cable
160 g
Operating temperature 42 °C (at an ambient temperature of
20 °C)
Max. power of the LED 5 W
Max. current of the LED 700 mA
Rated power of the LED 3.3 W
Rated current of the LED 530 mA
Mode: intermittent operation
Operating time 1 minute
Pause time 1 minute
Dimensions
Length including fibre-optic cable 200mm
Diameter 25mm
Cross-section of the optically active
surface of the fibre-optic cable
0.385 cm2 (38.5 mm2)
Operating environment
WARNING
Inappropriate operating conditions.
Impairment of the electrical safety of the device.
▶It is essential to comply with the operating conditions specified in the
"Technical Specifications" chapter.
Ambient temperature +10 to +40 oC
Relative Humidity 30% to 75% non-condensing
Air pressure 700 hPa - 1,060 hPa
Max. altitude for operation up to 3000 m

Instructions for use KaVo polymerisation light Poly One
3 Description of the Product | 3.1 Technical Specifications
Transportation and storage conditions
Ambient temperature -20 to +55 oC
Relative Humidity 5% to 95% non-condensing
Air pressure 700 hPa to 1,060 hPa
15 / 26

Instructions for use KaVo polymerisation light Poly One
4 Commissioning
16 / 26
4 Commissioning
Note
Use the curing light Poly One with glare protection only.
▶Slide the glare protection onto the optical fibre until it hits against the limit
stop.
▶Insert the optical fibre into the handpiece until it hits against the limit stop.
▶Check the proper positioning of the optical fibre.

Instructions for use KaVo polymerisation light Poly One
5 Operation
5 Operation
WARNING
Danger from defective or damaged products.
Injury to the patient.
▶Work with flawless, undamaged products only.
▶Carry out a visual inspection before each use.
WARNING
Hazard from non-sterile products.
Infection hazard for care provider and patient.
▶Sterilise the optical fibre prior to first use and after each use.
CAUTION
Damage from improper use.
Injury to the patient.
▶Check the secure fit of the fibre-optic cable/glass rod before each use.
Note
For curing, hold the fibre-optic cable such that it is close to the intended cur-
ing site. Keep a minimum distance of 0.5 cm from the material to exclude
possible damage or hazards.
The following curing times are available for selection:
▪ 20 seconds
▪ 40 seconds
▪ 60 seconds
Note
The curing light Poly One shuts off automatically once the selected time is
elapsed.
17 / 26

Instructions for use KaVo polymerisation light Poly One
5 Operation
18 / 26
▶Press button briefly to set the curing time to 20 seconds.
ðCuring light is on for 20 seconds and then shuts off.
▶Press button until you hear two acoustical signals to set the curing time to
40 seconds.
ðCuring light is on for 40 seconds and then shuts off.
▶Press button until you hear three acoustical signals to set the curing time to
60 seconds.
ðCuring light is on for 60 seconds and then shuts off.
▶Press the button to terminate the curing time.
ðThe curing light shuts off.
▶Hold the handpiece in an ergonomic hand position and place it on the re-
spective curing site.

Instructions for use KaVo polymerisation light Poly One
6 Reprocessing methods according to ISO 17664 | 6.1 Cleaning
6 Reprocessing methods according to ISO 17664
KaVo recommends to use original KaVo parts® for operation and repair only,
since their safety, function, and specific suitability have been tested in extens-
ive tests.
NOTICE
Property damage caused by improper cleaning/disinfection.
▶Do not wash the curing light Poly One in the washer disinfector.
▶Do not sterilise the curing light Poly One in the hot-air steriliser.
▶Do not place the curing light Poly One in a disinfection or ultrasonic bath.
Note
For cleaning/reprocessing of the fibre-optic cable of the curing light Poly One,
the fibre-optic cable must be removed from the handpiece.
6.1 Cleaning
6.1.1 Manual cleaning
Note
Combine manual cleaning with disinfection.
Internal cleaning
Not applicable.
External cleaning
Accessories required:
▪ Tap water 30oC ± 5oC
▪ Brush, e.g. medium-hard toothbrush
▶Hold the curing light Poly One by the handpiece and disassemble the fibre-
optic cable.
▶Disassemble the silicone holder and protective shield.
▶Clean the fibre-optic cable, protective shield, and silicone holder with a
brush and running water (at least tap water quality).
19 / 26

Instructions for use KaVo polymerisation light Poly One
6 Reprocessing methods according to ISO 17664 | 6.2 Disinfection
20 / 26
▶Immediately remove contamination from materials used in the dental office
using a soft cloth and alcohol.
▶Clean the handpiece with a soft, moist cloth.
6.1.2 Automated cleaning
NOTICE
Property damage caused by improper cleaning/disinfection.
▶Do not sterilise the fibre-optic cable in a hot-air steriliser.
▶Subject the fibre-optic cable to thermodisinfection and sterilisation.
6.2 Disinfection
6.2.1 Manual disinfection
External disinfection
Approved disinfectants:
▪ Mikrozid AF Liquid (made by Schülke & Mayr)
▪ FD 322 (Dürr)
▪ Incidin Liquid (Ecolab)
▪ CaviCide / CaviWipes (Metrex)
▶Perform wipe disinfection only, the use of spray disinfection and disinfection
baths is not feasible.
▶Wipe the handpiece, protective shield, fibre-optic cable, and silicone holder
with a soft cloth and approved disinfectants.
▶Use disinfectants according to the manufacturer's Instructions for Use.
▶Please note the disinfectant safety data sheet.
6.2.2 Automated disinfection
NOTICE
Property damage caused by improper cleaning/disinfection.
▶Do not sterilise the fibre-optic cable in a hot-air steriliser.
▶Subject the fibre-optic cable to thermodisinfection and sterilisation.
6.3 Drying
6.3.1 Manual drying
▶Blow off the outside of handpiece, protective shield, fibre-optic cable, and
silicone holder with compressed air until no water drops are visible any
longer.