KaVo ERGOcam One User manual

Instructions for use
ERGOcam One

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 Notes........................................................................................................................................................5
1.1 User guide ................................................................................................................................................5
1.1.1 Abbreviations ..............................................................................................................................5
1.1.2 Symbols ......................................................................................................................................5
1.1.3 Target group ...............................................................................................................................5
1.2 Service......................................................................................................................................................5
1.2.1 Technical customer service ........................................................................................................6
1.3 Terms and conditions of warranty.............................................................................................................6
1.4 Transportation and storage.......................................................................................................................6
1.4.1 Currently valid packaging regulations .........................................................................................6
1.4.2 Damage in transit........................................................................................................................ 6
1.4.3 Information on the packaging: Storage and transportation ......................................................... 7
2 Safety ...............................................................................................................................................................9
2.1 Description of safety instructions ..............................................................................................................9
2.1.1 Warning symbol ..........................................................................................................................9
2.1.2 Structure .....................................................................................................................................9
2.1.3 Description of hazard levels........................................................................................................ 9
2.2 Purpose – Proper use ..............................................................................................................................9
2.2.1 General .......................................................................................................................................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 handle .........................................................................................................................15
3.3 Technical Specifications .........................................................................................................................15
3.4 System requirements..............................................................................................................................17
4 Commissioning ...............................................................................................................................................18
4.1 Connecting the camera...........................................................................................................................18
4.1.1 Dentist element .........................................................................................................................18
4.2 Carry out a safety check. ........................................................................................................................19
4.3 Use of disposable protective covers .......................................................................................................20
5 Operation........................................................................................................................................................22
5.1 Switching the camera on and off ............................................................................................................22
5.2 Focusing of the camera ..........................................................................................................................22
5.3 Taking image ..........................................................................................................................................22
5.4 Operating mode ......................................................................................................................................23
6 Preparation methods ......................................................................................................................................24
6.1 Cleaning..................................................................................................................................................24
6.1.1 Exterior cleaning by hand .........................................................................................................24
6.2 Disinfection .............................................................................................................................................24
6.2.1 Exterior disinfection by hand..................................................................................................... 24
Instructions for use ERGOcam One
Table of contents
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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
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Instructions for use ERGOcam One
1 User Notes | 1.1 User guide
1 User Notes
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
See the Safety/Warning Symbols section
Important information for users and technicians
CE mark (European Community). A product bearing this mark meets the re-
quirements of the applicable EU directive.
Action required
1.1.3 Target group
This document is for dentists and dental office staff.
1.2 Service
Service hotline:
[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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Instructions for use ERGOcam One
1 User Notes | 1.3 Terms and conditions of warranty
6 / 30
1.2.1 Technical customer service
The technical support for KaVo products is primarily offered by the dental supplier.
KaVo provides ongoing training and special courses for dealer technicians.
To guarantee constant readiness for use and maintenance of value of the KaVO
products, the products must be regularly serviced.
1.3 Terms and conditions of warranty
KaVo provides the final customer with a warranty that the product cited in the han-
dover 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 war-
ranty 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 compens-
ation, are excluded. In the event of default and gross negligence or intent, 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 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 colour-
fastness 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) belong-
ing to the product has been sent to KaVo, and the original can be presented by the op-
erator 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 companies. Com-
ply 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 re-
ceipt. The recipient and the representative of the shipping company must sign this
delivery receipt.

Instructions for use ERGOcam One
1 User Notes | 1.4 Transportation and storage
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. 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 packaging 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-mentioned oblig-
ations will mean that the damage will be considered to have arisen following deliv-
ery (in accordance with the General German Freight Forwarders´ Terms and Condi-
tions, 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 re-
ceipt. 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 packaging on
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.
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 servicing or
repair.
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Instructions for use ERGOcam One
1 User Notes | 1.4 Transportation and storage
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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

Instructions for use ERGOcam One
2 Safety | 2.1 Description of safety instructions
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 docu-
ment to prevent personal and property damage.
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:
NOTICE
In cases which – if not prevented – could lead to material damage.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property or mild to moder-
ate 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 in-
jury.
2.2 Purpose – Proper use
2.2.1 General
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.
This KaVo product is intended for use in dentistry only. Any other type of use is not
permitted.
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Instructions for use ERGOcam One
2 Safety | 2.2 Purpose – Proper use
10 / 30
"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!

Instructions for use ERGOcam One
2 Safety | 2.2 Purpose – Proper use
Note
KaVo cannot guarantee the compliance of accessories, cables, and other compon-
ents 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 compliance
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
devices, this product is subject to the cited directive and must be disposed of ac-
cordingly within Europe.
Before disassembling / disposing of the product, it must be completely processed
(disinfected, sterilized) according to the section "Preparation methods"
Additional information can be obtained from KaVo (www.kavo.com) or your dental
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
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 com-
plete it as an online order.
2. Enter the corresponding information to complete the order, and submit it as an on-
line 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, trans-
portation and packaging.
International
For country-specific information on disposal, contact your dental supplier.
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Instructions for use ERGOcam One
2 Safety | 2.3 Safety instructions
12 / 30
2.2.2 Product-specific
The intraoral camera serves the generation of video signals for visualisation e.g. the
oral cavity of a patient via a suitable display medium. The generated data is used for
the patient´s information and to support the diagnosis.
The camera is a class II medical device according to the EC directive 93/42/EEC and
meets the requirements of 89/336/EEC in regard to electromagnetic compatibility.
The LED lighting is not harmful to eyes according to photobiological observation and
complies with the classification "Free Group" according to IEC 62471.
The camera is designed to be installed in dental treatment units according to DIN EN
ISO 7494.
2.3 Safety instructions
2.3.1 Product-specific
WARNING
Danger of injury from electric 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 60601-1, IEC 60950 or IEC
601010 to the system.
WARNING
Danger of injury due to voltage at an operating height of above 3 000 m. The device
is only insulated for heights of up to 3 000 m.
Electric shock
▶ Only use the device at operating heights of up to 3 000 m.
WARNING
Highly flammable gases-.
Explosion.
▶ Allow product to cool before disinfecting.
WARNING
Danger of choking or injury when the camera is inserted too deeply.
Vomiting, aspiration of vomit.
Injuries.
▶ Do not insert the camera to a depth of more than 70 mm.
▶ Do not insert the camera into the patient's throat!
WARNING
Risk of infection due to soiled or contaminated camera
Infection.
▶ When 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.

Instructions for use ERGOcam One
2 Safety | 2.4 Protective equipment
CAUTION
Danger to health due to wrong diagnosis as a result of a camera image. The camera
is not a diagnostic instrument!
Danger of incorrect treatment.
▶ Do not use the camera as a diagnostic instrument.
▶ Include other diagnostic tools (e.g. probe/X-ray) to obtain a diagnosis.
CAUTION
Danger of injury due to breakage of the camera window.
Swallowing or aspiration of camera parts during operation without protective cover.
Damage to the camera.
▶ Only use the camera with the protective cover.
▶ Protect the camera from impact.
▶ Ensure that patients do not bite on the camera.
CAUTION
Danger of injury due to the intensive radiation energy from the camera light.
Temperature increase in the tissue, irreversible tissue 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 point the camera with activated LED lighting toward the eyes!
CAUTION
Danger of injury due to excessive temperatures at the light exit port/camera head.
Burns
▶ Prevent the light exit port from coming into contact with tissue or mucous mem-
brane.
CAUTION
Product damage due to kinking or pinching the connection cable.
Irreversible break of the connection cable.
▶ Do not pull on the connection cable!
CAUTION
Material damage due to improper use.
Destruction of the camera housing and the components inside.
▶ Do not use the camera to move the dentist's element.
▶ Do not lean on the camera in the holder.
2.4 Protective equipment
Note
Personal protective equipment is not required by reason of the classification of this
medical device in the "Free Group" according to IEC 62471.
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Instructions for use ERGOcam One
3 Description of the product | 3.1 System components
14 / 30
3 Description of the product
3.1 System components
①Deflection prism ②Exposure window
③Camera head ④Camera handpiece with connecting
cable
⑤Trigger ⑥Interface of the treatment unit

Instructions for use ERGOcam One
3 Description of the product | 3.2 IDs and labels
3.2 IDs and labels
3.2.1 Camera handle
1
2
3
4
5
6
8
7
ERGOcam One
1.00x.xxxx
SN 2014-000X
MADE IN GERMANY
0 1 2 4
①Product name ②Company logo of the manufacturer
③SN for serial number ④Mat. number
⑤Disposal instructions ⑥Classification (earth-free applied part
type BF)
⑦Read and take note of the content of
accompanying documents
⑧CE mark according to 93/42/EEC
medical devices
3.3 Technical Specifications
WARNING
Danger of injury due to voltage at an operating height of above 3 000 m. The device
is only insulated for heights of up to 3 000 m.
Electric shock
▶ Only use the device at operating heights of up to 3 000 m.
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Instructions for use ERGOcam One
3 Description of the product | 3.3 Technical Specifications
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Image Detector
Colour sensor 1/4“ CMOS
Pixel PAL 1276 (H) x 769 (V)
Camera module
Type USB 2.0
Illumination 1 LED
Illumination intensity at 10 mm distance 40 klux
Overall power consumption ≤ 295 mA (at 5 V ±10 mV)
Supply USB - BUS powered
Optical system
Angle of view 90°
Working distance 10 - 25 mm
Diagonal aperture angle 54°
Operating environment
Ambient temperature 10 to 40 oC
Relative humidity 30 to 75%
Air pressure 700 to 1060 mbar
Max. elevation for operation up to 3 000 m
Transportation and storage conditions
Temperature range -20 to 55 oC
Relative humidity 5% to 95% non-condensing
Air pressure 700 to 1 060 mbar
Length of connecting cable
Mat. no. 1.011.2130 1 300 mm
Mat. no. 1.011.2129 1 600 mm
Camera package
Length 290mm
Width 160mm
Height 80mm

Instructions 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
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Instructions for use ERGOcam One
4 Commissioning | 4.1 Connecting the camera
18 / 30
4 Commissioning
Note
A PC is required for the operation of the camera (not included in the delivery)
Note
The ERGOcam One may only be used on equipment which at least fulfil the stand-
ard EN DIN ISO 60950.
Note
The distance between the PC and camera cable (floor terminal box) must not ex-
ceed 10 m. High-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 the camera at the connection.
CAUTION
The connecting cable is firmly connected to the camera handpiece.
Product damage
▶ Do not remove the connecting cable from the camera handpiece.
Note
Defective camera function.
The camera can indicate a defective function if the PC, to which the camera is con-
nected, is set in into idle, standby or hibernation mode.
▶ Turn off the PC and switch off.

Instructions for use ERGOcam One
4 Commissioning | 4.2 Carry out a safety check.
CAUTION
Wrong insertion into the USB socket.
USB - plug can only be inserted into the correct position. Forceful insertion leads to
destruction of the plug.
▶ Check the correct position before inserting the plug.
After connecting the camera to the PC, check the correct installation of the camera on
the PC. The camera uses uses system drivers in windows, installation follows auto-
matically by plugging into a USB port.
Note
If the camera is plugged into another USB port of the PC, the installation for this
USB port will be automatically repeated.
Note
In the case of turbulent video operation, an unsuitable front USB port has been
used which is not optimally connected to the main board of the PC. Plug the camera
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 device "ERGOcam One" is displayed in the device manager under image pro-
cessing device.
Note
An additional software e.g. Conexio is required for the display / storage of camera
images on the PC.
The assembly of the camera is described in the instructions for assembly and use of
the respective treatment unit.
4.2 Carry out a safety check.
WARNING
Danger of injury from electric current.
Electric shock.
▶ Carry out a safety check after connecting the camera.
▶ Do not continue working with a damaged camera!
▶ Only connect accessories that conform with IEC 60601-1, IEC 60950 or IEC
601010 to the system.
▶ Let the service technician carry out the safety check.
▶ Check the housing and the connection cable of the camera for cracks and dam-
age.
See also:
2Instructions for use of the treatment unit.
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Instructions for use ERGOcam One
4 Commissioning | 4.3 Use of disposable protective covers
20 / 30
4.3 Use of disposable protective covers
Remove the disposable protective cover
WARNING
Risk of infection due to soiled or contaminated camera
Infection.
▶ When 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 product with this designation once!
Note
Disposable protective covers can be ordered underMat. no. 1.011.3586.
▶ Remove the camera from the holder
▶ Remove the protective cover from the camera slowly to enable the air to escape.
▶ Remove the outer protective paper.