KaVo Poly One User manual

Instructions for use
KaVo polymerisation light Poly One
Always be on the safe side.

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

Table of contents
1 User instructions ........................................................................................................................................ 2
1.1 User guide ....................................................................................................................................... 2
1.1.1 Abbreviations ...................................................................................................................... 2
1.1.2 Symbols .............................................................................................................................. 2
1.1.3 Target group ....................................................................................................................... 2
1.2 Service ............................................................................................................................................ 2
1.3 Warranty terms and conditions ........................................................................................................ 3
1.4 Transportation and storage ............................................................................................................. 3
1.4.1 Currently valid packaging regulations ................................................................................ 3
1.4.2 Damage in transit ............................................................................................................... 4
1.4.3 Information on the packaging: Storage and transportation ................................................ 5
2 Safety ........................................................................................................................................................ 6
2.1 Description of safety instructions ..................................................................................................... 6
2.1.1 Warning symbol .................................................................................................................. 6
2.1.2 Structure ............................................................................................................................. 6
2.1.3 Description of hazard levels ............................................................................................... 6
2.2 Purpose – Proper use ...................................................................................................................... 6
2.2.1 General information ............................................................................................................ 6
2.2.2 Product-specific .................................................................................................................. 7
2.3 Safety instructions ........................................................................................................................... 9
2.3.1 General information ............................................................................................................ 9
2.3.2 Product-specific .................................................................................................................. 9
3 Description of the Product ....................................................................................................................... 11
3.1 Technical Specifications ................................................................................................................ 12
4 Commissioning ........................................................................................................................................ 14
5 Operation ................................................................................................................................................. 15
6 Reprocessing methods according to ISO 17664 ..................................................................................... 17
6.1 Cleaning ........................................................................................................................................ 17
6.1.1 Manual cleaning ............................................................................................................... 17
6.1.2 Automated cleaning .......................................................................................................... 18
6.2 Disinfection .................................................................................................................................... 18
6.2.1 Manual disinfection ........................................................................................................... 18
6.2.2 Automated disinfection ..................................................................................................... 19
6.3 Drying ............................................................................................................................................ 19
6.3.1 Manual drying ................................................................................................................... 19
6.3.2 Automatic Drying .............................................................................................................. 19
6.4 Sterilisation .................................................................................................................................... 19
6.5 Storage .......................................................................................................................................... 20
7 Troubleshooting ....................................................................................................................................... 21
8 Accessories and spare parts ................................................................................................................... 22
Instructions for use KaVo polymerisation light Poly One
Table of contents
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1 User instructions
1.1 User guide
Requirement
Read these instructions prior to first use to avoid misuse and prevent damage.
1.1.1 Abbreviations
Abbre‐
viation
Explanation
IfU Instructions for use
CI Care instructions
AI Assembly instructions
TI Technician's instructions
SC Safety checks
IEC International Electrotechnical Commission
RI Repair instructions
RK Retrofitting kit
AS Assembly set
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]
[email protected]
Please refer to the serial number of the product in all inquiries!
For further information, please visit: www.kavo.com
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1.3 Warranty terms and conditions
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 ma‐
terial 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 cus‐
tomer's wishes. Other claims of any nature whatsoever, in particular with respect
to compensation, are excluded. In the event of default and gross negligence or in‐
tent, this shall only apply in the absence of mandatory legal regulations to the
contrary.
KaVo cannot be held liable for defects and their consequences due to natural
wear, improper cleaning or maintenance, non-compliance with operating, mainte‐
nance or connection instructions, calcification or corrosion, contaminated air or
water supplies or chemical or electrical factors deemed abnormal or impermissi‐
ble 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) be‐
longing 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 cur‐
rent packaging regulations, employing waste management or recycling compa‐
nies. 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.
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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.
6. You must consult with KaVo 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 packaging
upon 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-mentioned
obligations will mean that the damage will be considered to have arisen following
delivery (in accordance with the General German Freight Forwarders´ 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 dam‐
ages 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 packaging
upon delivery, proceed as follows:
1. Report any damage to the shipping company either immediately or 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.
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Note
Failure on the part of the recipient to comply with any of the above-mentioned
obligations will mean that 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 servicing
or repair.
The symbols printed on the outside are for transportation and storage, and have
the following meaning:
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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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
Safety instructions distinguishing between three hazard levels are used in this
document to prevent personal and property damage.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property or mild to
moderate injuries.
WARNING
WARNING
indicates a hazardous situation that can lead to serious or fatal injury.
DANGER
DANGER
indicates a maximal hazard due to a situation that can directly cause death or
fatal injury.
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.
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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.
The applicable national legal regulations must be observed during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and start-up of medical devi‐
ces.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
Users have a duty to:
▪ Only use equipment that is operating correctly
▪ to protect himself, the patient and third parties from danger.
▪ to avoid 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 condi‐
tion before each use.
Information on electromagnetic compatibility
Note
Based on IEC 60601-1-2 (DIN EN 60601-1-2) concerning the electromagnetic
compatibility of electrical medical devices, we must draw your attention to the fol‐
lowing 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.
• Portable and mobile high-frequency communications devices can affect the op‐
eration of electrical medical devices.
Further details on the technical EMC description are available on request.
See also: For "Specific details concerning electromagnetic compatibility in accord‐
ance with EN 60601-1-2", see the instructions for use of the respective treatment
centre
Note
KaVo cannot guarantee the compliance of accessories, enclosed cables, and
other components not supplied by KaVo with EMC requirements of IEC
60601-1-2 (DIN EN 60601-1-2).
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Disposal
Note
Any waste which is generated must be recycled or disposed of in strict compli‐
ance 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.
Disposal of electronic and electrical devices
Note
According to EC directive 2002/96 concerning used electrical and electronic de‐
vices, this product is subject to the cited directive and must be disposed of ac‐
cordingly within Europe.
For more information, please visit www.kavo.com or contact your specialised
dental supplier.
For final disposal, please contact:
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 or‐
der 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 initiating
a disposal order:
Phone: [phone]
Email: [email protected] 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 dental supplier.
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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.
WARNING
Application of un-authorised accessories or un-authorised modifications 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 material damage.
▶Only use accessories that have been approved for the 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.
CAUTION
Premature wear and malfunctions from improper servicing and care.
Reduced product life.
▶Perform regular proper care and maintenance!
The following persons are authorised to repair and service the KaVo product:
▪ Technicians of KaVo branch offices after appropriate product training.
▪ Specifically KaVo-trained technicians of KaVo franchised dealers.
Decommissioning
WARNING
Disposal of the product in the appropriate manner.
Prior to disposal, the product must be appropriately prepared or sterilised if this
is necessary.
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.
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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 process‐
ing and curing time of the filling material.
CAUTION
Product damage from kinking or crushing the handpiece hose.
Irreversible rupture of the lines in the handpiece hose.
▶Do not pull on the handpiece hose!
CAUTION
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!
CAUTION
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.
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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)
① Fibre-optic cable
(Mat. no. 3.000.3812)
⑧ Connector on the unit
② Protective shield
(Mat. no. 3.000.3811)
⑨ Reference number/product name
③ Button "Select curing time" and/or
"On/Off"
⑩ Type B application part
④ Manufacturer ⑪ Comply with the safety-related infor‐
mation in the instructions for use
⑤ Made in Germany ⑫ Optical radiation warning in accord‐
ance with DIN 4844-2
⑥ SN YYYY-MM-XXXX ⑬ CE mark according to 93/42/EEC
medical devices
⑦ Handpiece hose (1,600 mm for as‐
sistant element)
The curing light Poly One emits visible blue light of a wavelength between 450 to
460 nm for photopolymerisation of dental materials.
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3.1 Technical Specifications
Light source LED
Sterilisable parts Fibre-optic cable made of glass
Wavelength 450 - 460 nm
Curing times 3 curing times: 20, 40 or 60 seconds
Minimal radiation power 800 mW/cm2
Weight of handpiece and fibre-optic ca‐
ble
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
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 "Tech‐
nical Specifications" chapter and not to exceed those conditions.
Ambient temperature +10 to +40 °C
Relative humidity 30 to 75%
Air pressure 700 to 1,060 hPa
Max. elevation for operation up to 3000 m
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Transportation and storage conditions
Ambient temperature -20 to +55°C
Relative humidity 5% to 95% non-condensing
Air pressure 700 to 1,060 hPa
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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
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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.
The following curing times are available for selection:
▪ 20 seconds
▪ 40 seconds
▪ 60 seconds
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Note
The curing light Poly One shuts off automatically once the selected time is
elapsed.
▶ Press button briefly to set the curing time to 20 seconds.
Curing 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.
Curing 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.
Curing light is on for 60 seconds and then shuts off.
▶ Press the button to terminate the curing time.
The curing light shuts off.
▶ Hold the handpiece in an ergonomic hand position and place it on the respec‐
tive curing site.
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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 extensive
tests.
CAUTION
Damage caused by improper cleaning/disinfection.
▶Do not wash the curing light Poly One in the thermodisinfector.
▶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 ultrasound 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 30°C ± 5°C
▪ Brush, e.g. medium-hard toothbrush
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▶ Hold the curing light Poly One by the handpiece and disassemble the fibre-op‐
tic 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).
▶ Immediately remove contamination from materials used in the dental office us‐
ing a soft cloth and alcohol.
▶ Clean the handpiece with a soft, moist cloth.
6.1.2 Automated cleaning
CAUTION
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 (Metrex)
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