KaVo ERGOcam One Instructions For Use Manual Download Page 10

Instructions for use ERGOcam One

2 Safety | 2.2 Purpose – Proper use

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"Proper use" includes compliance with all instructions for use and the inspection and
maintenance intervals.
The user must ensure that the unit works properly and is in satisfactory condition be-
fore each 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 start-up of medical devices.

▪ Current occupational safety regulations.

▪ Current accident prevention regulations.

It is a responsibility of the user:

▪ only use equipment that is operating correctly,

▪ protect him or herself, the patient and third parties from danger, and

▪ avoid contamination from the product..

This KaVo product may only be repaired at the KaVo factory Warthausen.
Regular performance of maintenance and safety checks is essential for the permanent
assurance of the operating and functional safety of the KaVo product and for the pre-
vention of damage and hazards.
Testing and maintenance intervals: Maintenance must be performed once a year, the
safety check (STK) at intervals of 2 years. Shorter intervals for the safety check may
be specified by the tester if necessary.

Note

The product must be cleaned and serviced according to instructions if it is not to be
used for an extended period of time.

Information on electromagnetic compatibility

Note

Based on IEC 60601-1-2 (DIN EN 60601-1-2) concerning the electromagnetic com-
patibility of electrical medical devices, we must draw your attention to the following
points:
• Electrical medical devices are subject to special precautionary measures regard-
ing electromagnetic compatibility and must be operated in accordance with the
KaVo installation instructions.
• High-frequency communications devices can affect the operation of electrical
medical devices.
Further details of the technical EMC description are available on request.

 CAUTION

Damage from unsuitable accessories.
The use of accessories, other components, and cables other than those specified
(with the exception of components and cables sold by KaVo as spare parts for in-
ternal components) can increase emissions or reduce the electromagnetic immunity
of the product.

▶ Use accessories recommended by KaVo only!

Summary of Contents for ERGOcam One

Page 1: ...Instructions for use ERGOcam One...

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

Page 3: ...9 2 2 2 Product specific 12 2 3 Safety instructions 12 2 3 1 Product specific 12 2 4 Protective equipment 13 3 Description of the product 14 3 1 System components 14 3 2 IDs and labels 15 3 2 1 Camera...

Page 4: ...6 3 Maintenance 25 7 Troubleshooting 26 8 Information about electromagnetic compatibility in accordance with EN60601 1 2 27 Instructions for use ERGOcam One Table of contents 4 30...

Page 5: ...s RK Retrofitting kit AS Assembly set EP Enclosed parts EMC Electromagnetic compatibility PI Processing instructions 1 1 2 Symbols See the Safety Warning Symbols section Important information for user...

Page 6: ...ing 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...

Page 7: ...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 los...

Page 8: ...8 30 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 fro...

Page 9: ...personal injury and material damage The warning notes are designated as shown below NOTICE In cases which if not prevented could lead to material damage CAUTION CAUTION indicates a hazardous situation...

Page 10: ...ntenance intervals Maintenance must be performed once a year the safety check STK at intervals of 2 years Shorter intervals for the safety check may be specified by the tester if necessary Note The pr...

Page 11: ...ntal supplier For final disposal In Germany The product can be disposed of by the following routes as electronic scrap at a collecting point by means of a disposal service contract with enretec GmbH T...

Page 12: ...tric current Electric shock Before connecting the camera tube turn off the supply voltage to the device Do not continue working with a damaged camera Only connect accessories that conform with IEC 606...

Page 13: ...e damage pulpitis or coagula tion Do not exceed the maximum observation time of 1 minute for one tooth in macro mode CAUTION Danger of blinding due to active LED lighting Reversible blinding Do not po...

Page 14: ...3 Description of the product 3 1 System components 14 30 3 Description of the product 3 1 System components Deflection prism Exposure window Camera head Camera handpiece with connecting cable Trigger...

Page 15: ...serial number Mat number Disposal instructions Classification earth free applied part type BF Read and take note of the content of accompanying documents CE mark according to 93 42 EEC medical device...

Page 16: ...red Optical system Angle of view 90 Working distance 10 25 mm Diagonal aperture angle 54 Operating environment Ambient temperature 10 to 40 o C Relative humidity 30 to 75 Air pressure 700 to 1060 mbar...

Page 17: ...uctions for use ERGOcam One 3 Description of the product 3 4 System requirements 3 4 System requirements CPU cycle min 2 GHz Memory min 1 GB Graphic requirements min 24 bit 1024x768 Interface USB 2 0...

Page 18: ...gh quality active USB extension maximum 5 m long each must be used KaVo recommends one or two USB extensions 5m Mat no 1 004 6953 4 1 Connecting the camera 4 1 1 Dentist element Insert the USB plug of...

Page 19: ...ra into an alternative USB port of the PC Verification of correct installation A further USB input device is displayed under device manager human interface device following connection of the camera A...

Page 20: ...hen using the camera always use a disposable protective cover Renew the disposable cover after each patient Do not use damaged covers Wipe the camera down with disinfectant after use Only use a produc...

Page 21: ...iew window of the single use cover must be precisely over the exposure window of the camera Tighten the clear view window in front of the exposure window of the camera This enables sharper imaging Not...

Page 22: ...a in the holder The camera automatically switches off Note You can see if the camera is working properly by the video image and an active LED CAUTION Danger of blinding due to active LED lighting Reve...

Page 23: ...ode 10 25 mm The camera presents a sharp image at a distance of 10 25 mm camera tooth It is designed for the imaging of a tooth Imaging of a dental arch or extraoral images are not possible Note It is...

Page 24: ...by hand CAUTION Damage to camera due to improper cleaning To avoid the surface or optical system of the camera being destroyed Do not use abrasives or aggressive cleaning substances Do not immerse ca...

Page 25: ...he camera Disinfect the surface using a soft wipe and disinfectant Approved disinfectants MIKROZID Pump Spray manufacturer Sch lke Mayr D rr System Hygiene FD 322 Spray disinfection manufacturer D RR...

Page 26: ...PC was in hibernate mode Shut down the PC and restart No reaction from camera LEDs do not light up PC is not switched on de fective Switch on exchange PC The camera is defective Exchange the camera U...

Page 27: ...accordance with EN60601 1 2 8 Information about electromagnetic compatibility in accordance with EN60601 1 2 See also 2 For Specific details concerning electromagnetic compatibility in accordance wit...

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Page 30: ...1 011 3682 Fk 20160810 2 en...

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