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Summary of Contents for FotoFinder vexia
- Page 2 FotoFinder vexia Original user manual Please read these original operating instructions carefully before using the device and always keep it easily accessible! Copyright © 2024 FotoFinder Systems GmbH Status: 25.06.2024...
- Page 3 FotoFinder Systems GmbH Industriestraße 12 84364 Bad Birnbach Germany www.fotofinder.de info@fotofinder.de Tel.: +49 (0) 8563 97720-0 Fax: +49 (0) 8563 97720-10...
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Page 4: Table Of Contents
3.12.6 EMC tested cables, transformers and accessories.............. 21 3.12.7 Recommended minimum distance between portable and mobile RF communication devices and the FotoFinder device ..................22 3.13 Moving the mounted device ..................... 23 3.14 Maximum load of the components ................... 23 4 Installation ........................ - Page 5 Switching on the device ......................29 Ending operations ........................29 6 Cleaning and disinfection ....................30 Cleaning the device ........................30 Disinfection of the device ......................30 7 Maintenance ......................... 31 8 Malfunction and troubleshooting ................... 32 Error handling..........................32 Problems with the hardware ....................
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Page 6: About These Operating Instructions
Trichoscopy Capillaroscopy and Inflammoscopy. The development and production of all products of FotoFinder Systems GmbH is carried out in accordance with the current ISO 13485 standards. Please note the following points when using the product and this user manual: The product can only be used, operated and maintained properly and safely with the help of this user manual. -
Page 7: Presentation Of Warning Labels
1.3 Presentation of warning labels In the operating instructions, warnings are marked with a signal word panel. Warnings are introduced with signal words expressing the extent of the hazard. Observe all warnings to avoid accidents, personal injury and damages. The following signal words and symbols are used in the operating instructions: This is the general hazard sign. -
Page 8: Information On The Device Label
Frequency Mains frequency Unique serial number of the device Month and year of manufacture UK Conformity Assessed Party responsible for UK: FotoFinder Systems Ltd., 100 Addison Road, W148DD London, United Kingdom Output Nominal voltage/nominal current at the isolating transformer output... -
Page 9: Explanation Of The Symbols
Electronic user manual 1.5 Explanation of the symbols Do not stand on surface Do not push this device component Equipotential bonding Indicates the Swiss representative: Johner Medical Schweiz GmbH, Tafelstattstrasse 13a, 6415 Arth, Switzerland Tab. 1: Further symbols on the system... -
Page 10: System Components And Technical Data
System components and technical data 2 System components and technical data... - Page 12 System components and technical data The FotoFinder vexia comprises the following components: Fig. 1: FotoFinder vexia Monitor Isolating transformer (with master switch and LAN port) Keyboard Mouse on extractable shelf Drawer medicam 1000 Compartment with docking station Castors with locking brakes...
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Page 13: Safety
Documentation of patient-relevant image data Documentation of nevi Non-invasive, short-term, digital dermoscopy of intact skin The system is designed to be used for and can only be used in combination with the FotoFinder Universe software. Only use the supported dermatoscopes medicam 1000 and leviacam... -
Page 14: User Groups
There are no additional requirements for the social or clinical environment of use. The product is not intended for use by laypersons. NOTE Feel free to contact FotoFinder Systems to discuss the best design for your photography room. Please contact us! -
Page 15: Patient Population
The device is designed for clinical images as stated in the chapter Patient target group . For a detailed list of ICD codes, please contact info@fotofinder.de. The following parts of the body are suitable for examination with the FotoFinder dermatoscope: Intact skin surface of the entire body Scalp Nails The device is not designed for capturing images of mucous membranes, eyes or natural or artificial body orifices. -
Page 16: Foreseeable Misuse
Safety 3.8 Foreseeable misuse The following points describe foreseeable misuse of the device: Incorrect setup Non-compliance to operating data Non-compliance to maintenance intervals Operation without or damaged components serving the safety of persons or the device 3.9 Residual risks WARNING Despite compliance with all regulations and the implementation of risk-minimizing measures, not all risks can be completely excluded. -
Page 17: Ambient Conditions
A final production check is carried out on the entire system or, if applicable, the components as per EN 62353 during in-house production. When commissioning is performed by a FotoFinder contact, the operator is encouraged to check and confirm the values of the in-house inspection. -
Page 18: Electric Safety
Do not remove the casing of the device: there is hazardous current inside. The casing must be correctly mounted. All repairs and replacements must be made by a qualified FotoFinder representative. Check the casing and cables before use. Do not use the device and disconnect it completely from the power supply, if the casing is cracked, chipped or broken, or if the casing or the cables are damaged. -
Page 19: Esd
Interference) requirements, an electromagnetic field can cause momentary disturbance of the camera live image. If this occurs often, FotoFinder Systems suggests a review of the environment in which the system is being used, to identify possible sources of interference. These could be from other electrical devices used within the same or a nearby room. -
Page 20: Emc
Safety 3.12.4 EMC The testing for EMC (Electromagnetic Compatibility) of this system has been performed according to the international standard for EMC with medical devices (IEC 60601-1-2:2014+A1:2020). This IEC standard complies with the European norm (EN 60601-1-2:2015+A1:2021). European publication Surroundings of professional medical Deviation from basic facilities EMC standards or... -
Page 21: Instructions And Manufacturer's Information On Electromagnetic Radiation
Radiation test Compliance Electromagnetic environment - Directive RF emission Group 1 The FotoFinder device is not likely to cause CISPR 11 interference with other electronic devices in the vicinity. RF emission Class A... -
Page 22: Recommended Minimum Distance Between Portable And Mobile Rf Communication Devices And The Fotofinder Device
Safety 3.12.7 Recommended minimum distance between portable and mobile RF communication devices and the FotoFinder device This product is intended for use in an electromagnetic environment where the radiated RF disturbances are controlled. The user of this device can help prevent electromagnetic interference by... -
Page 23: Moving The Mounted Device
3.13 Moving the mounted device Basically, the built-up device should not be moved unnecessarily, as it could get damaged. Should it nevertheless be necessary, please note the following: The cart has a weight of 58 kg / 128 lbs. Therefore tilting and lifting for ergonomic reasons are out of the question. -
Page 24: Installation
Installation 4 Installation DANGER A device of Protection Class I Danger of injury due to electric shock. Connect the device to a properly grounded power outlet only. DANGER Danger of electric shock due to high voltage! Severe injury or death could result when touching an energized conductor. Work on electrical systems may only be conducted by authorized electricians. -
Page 25: Delivery Scope
4.1 Delivery scope Your FotoFinder product is dispatched as largely assembled. However, before commissioning, the following parts have to be attached and cabled. This task is performed by the respective FotoFinder consultant or the FotoFinder distributor. medicam Mouse and keyboard as required... -
Page 26: Connections On The System Cart
Installation 4.2 Connections on the system cart Fig. 2: Connections on the cart 4.2.1 The potential equalization plug Before you start up the device and connect the mains plug, first connect the potential equalization cable connected through the main potential equalization rail to the designated socket for potential equalization (POAG) (cf. -
Page 27: Main Voltage Settings On The System Cart
FotoFinder vexia T 4.0A T 2.0A 4.4 Use in a network It is possible to operate the system in a network with several FotoFinder Universe clients. The FotoFinder vexia ® includes a galvanic network isolator as per IEC 60601-1. NOTE... -
Page 28: Operation
Operation 5 Operation ATTENTION Under no circumstances stand on top of the PC or PC stand. The structure might break. ATTENTION Never place any product that could leak on your equipment or over the power supply cables. Liquids could cause serious damage. ATTENTION May damage the camera cable. -
Page 29: Switching On The Device
The computer boots. You can tell this by the active logo on the front on the computer monitor. Start FotoFinder Universe*. NOTE *There are separate instructions for use for this FotoFinder product. 5.3 Ending operations Close Universe and any open software modules. -
Page 30: Cleaning And Disinfection
Cleaning and disinfection 6 Cleaning and disinfection WARNING Risk of infection as a result of insufficient hygiene. Clean the applied part after each patient. ATTENTION Sanitize with wipes only. Sanitize any components with sanitizing wipes only. ATTENTION Damage to the device and the screen caused by unsuitable cleaners. Do not use abrasive agents or sponges! Do not use solvents such as alcohol or gasoline! Do not use glass cleansers with anti-static solution! -
Page 31: Maintenance
Warning! This device must not be modified without the approval of the manufacturer! To ensure your system functions perfectly, subject your device to periodic inspections and repeat checks. At FotoFinder Systems we recommend that you carry out repeat checks as per EN 62353 every 12 months. -
Page 32: Malfunction And Troubleshooting
Check the cable and the connections between the monitor and the computer Check the signal (DVI, VGA or Display Port), press the "S" button on the front of the monitor several times until it is set correctly To minimize power problems, connect the vexia system directly with an installed power socket... -
Page 33: The Isolating Transformer When The System Has No Power
8.2.3 The isolating transformer when the system has no power Check the following points one after the other: the green control light on the isolating transformer is on the switch on the isolating transformer is on all cables are correctly plugged in on both ends the wall / floor socket has electricity (e.g. -
Page 34: Disposal
Disposal 9 Disposal ATTENTION Risk of environmental damages caused by improper disposal. For disposal, observe local regulations and legal requirements. By properly disposing of and recycling old equipment and used components, natural resources can be conserved and the environmental impact minimized. Therefore, please note the following points: The operator is responsible for proper disposal. -
Page 35: Glossary
FotoFinder's USB camera for capture and examination of lesions FotoFinder medicam* FotoFinder's digital video camera for capture and examination of lesions FotoFinder user software FotoFinder Universe* High definition Identification number for the TeamViewer software NOTE *There are separate instructions for use for this FotoFinder product. -
Page 36: Appendix
Appendix 11 Appendix...
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