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Instructions for use KaVo polymerisation light Poly One

1 User instructions | 1.1 User guide

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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

Care instructions

SIFU

Short instructions for use

Assembly instructions

Technician's instructions

IEC

International Electrotechnical Commission

Repair instructions

Retrofitting kit

Assembly kit

Conversion kit

Enclosed parts

EMC

Electromagnetic compatibility

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:
+49 (0) 7351 56-1000
[email protected] or [email protected]
Please refer to the serial number of the product in all inquiries!
For further information, please visit: www.kavo.com

Содержание Poly One

Страница 1: ...Instructions for use KaVo polymerisation light Poly One ...

Страница 2: ...Distributed by KaVo Dental GmbH Bismarckring 39 88400 Biberach Germany Phone 49 0 7351 56 0 Fax 49 0 7351 56 1488 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 88400 Biberach Germany www kavo com ...

Страница 3: ...se 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 ...

Страница 4: ...EC 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 ...

Страница 5: ...ications 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 ...

Страница 6: ... 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 ...

Страница 7: ... 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 7 26 ...

Страница 8: ... 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 u...

Страница 9: ...ic 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 commun...

Страница 10: ...oad 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 49 0 3304 3919 590 to enretec GmbH The following contact options are also available for questions and for initiat ing a disposal order Phone 49 0 3304 3919 500 Email eom enretec de and Postal address enretec GmbH Geschäftsbereich eomRECYCLI...

Страница 11: ...vicing 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 optic...

Страница 12: ...roper 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 ex...

Страница 13: ...lect curing time and or On Off Manufacturer Made in Germany SN YYYY MM XXXX Handpiece hose 1 600 mm for as sistant element Connector on the unit Reference number product name Type B application part Comply with the safety related in formation in the instructions for use Optical radiation warning in accord ance with DIN 4844 2 CE mark according to 93 42 EEC medical devices The curing light Poly One...

Страница 14: ...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 operatin...

Страница 15: ...risation light Poly One 3 Description of the Product 3 1 Technical Specifications Transportation and storage conditions Ambient temperature 20 to 55 o C Relative Humidity 5 to 95 non condensing Air pressure 700 hPa to 1 060 hPa 15 26 ...

Страница 16: ...sioning 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 ...

Страница 17: ...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 availa...

Страница 18: ...coustical signals to set the curing time to 40 seconds ð 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 ð Curing light is on for 60 seconds and then shuts off Press the button to terminate the curing time ð The curing light shuts off Hold the handpiece in an ergonomic hand position and place it on the r...

Страница 19: ...ir 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 30o ...

Страница 20: ...lke 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...

Страница 21: ...ce with DIN EN 13060 NOTICE Damage caused by over heating Damage to the fibre optic cable Immediately remove the parts from the steriliser after the sterilisation cycle is completed Weld the fibre optic cable in sterile goods packaging Sterilise with a triple fractionated vacuum B class steriliser hold for 4 minutes 134 C 1 C overpressure 2 13 bar 6 5 Storage Reprocessed products should be stored ...

Страница 22: ...defect ive Supply is interrupted LED defective Stop working and call the service technician Operating button is non functional Handpiece is defective Button is defective Stop working and call the service technician No timer signal Handpiece is defective Trigger is defective Stop working and call the service technician Fibre optic cable is at tached loosely Socket on fibre optic cable is defective ...

Страница 23: ...se KaVo polymerisation light Poly One 8 Accessories and spare parts 6 5 Storage 8 Accessories and spare parts Material number Accessories 3 000 3812 Fibre optic cable 3 000 3811 Protective shield 3 000 4240 O ring 23 26 ...

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Страница 26: ...1 010 0808 Fk 20200206 2 en ...

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