Optomed M5 Instructions for Use
Contents
1. counter On Off Mark side of the ET eee to the image data IR brightness Low High Aiming Aiming light brightness brightness Instant Review On Off Instant review can be ON OFF according to user need as available in FA Optics menu Target Blinking By default the fixation target light is on with constant illumination If patient cannot keep their eye targeted well the light can changed to blink to help focus on the target light Calibration Frequency 5 10 user User can manually set calibration frequency of the optics Start Study This enables the study to start For every new study user needs to go into the menu and start study to enable the study or Time counter Marking side It is possible to mark which eye was imaged Marking side is enabled from the menu When On side is marked to the file name and to the image For video files side is always marked only to the file name When marking side is enabled camera verifies side after each captured image Identifiers used for eye images are OS for left and OD for right IR Brightness IR brightness values are Low Med High This can be chosen by user by using left and right arrow keys Always high is recommended Instant review Instant review can be ON OFF according to user need as available in FA Optics menu Target blinking By default the fixation target light is on with constant illumination If patient cannot keep their eye targeted well the light can changed to blink t2. 95 Atmospheric pressure 500 hPa to 1060 hPa Sinusoidal vibration 10 Hz to 500 Hz 0 5 g Shock 30 g duration 6 ms Bump 10 g duration 6 ms CONTACT If you wish to contact your local support personnel please call to 800 345 8655 or email us at service Volk Optical com WARRANTY Volk Optical gives device a 1 year warranty for the parts and labor Warranty for battery is 6 months Submitting claim Any claim under this warranty must be submitted in writing before the end of warranty period to Volk Optical The claim must include a written description of the failure that the device have Warranty does not cover Products that have been subjected to abuse accident alternation modification tampering misuse faulty installation lack of reasonable care repair or service in any way that is not contemplated in the documentation of the product or if the model or serial number has been altered tampered with defaced or removed Warranty does not cover damage caused by dropping the device or damage caused by normal wearing Any issue related to the stickers attached to the device coming off are not covered by warranty Repair or service done by non Volk Optical certified service facility is not covered by warranty For customer support contact service Volk com IM 080 Rev A Page 12 of 16 Appendix A Electromagnetic compatibility information MEDICAL ELECTRICAL SYSTEM needs special precautions regarding EMC and needs to be installe
3. after capturing images Images are transferred to the PC when camera is placed to the cradle Pictor Plus works as any other digital camera When camera is removed from the cradle it verifies image data storage erase It is recommended that image data storage is always erased before images are captured of a new patient IM 080 Rev A Page 7 of 16 The camera keys function as shown in image below when VP2FA optics module is attached Focus manually Move fixation target Short Auto MF AF assist Move between tabs Long Menu Increase brightness Move fixation target Short Target low high off Move between tabs Long Power On Off Decrease Brightness Move fixation target Long New patient folder Focus manually Move fixation target Below table provides explanations for the key functions Press Function Explanation Key Short Control Fixation target Fixation target is off by default and can be turned on by pressing level and selection left soft key Fixation target light has two levels Low and High If Left soft key the patient cannot see the light on low level turn it up to high Long Power On Off Camera is powered on and off by pressing the Left soft key for longer than 2s Short Manual Auto Switch between focus modes by pressing Right soft key Manual ok focus is on by default Autofocus range is 11 to 3 diopters ight soft ke I i manual focus range is 20 to 20 diopters
4. counter will guide you through out through the all phases of Angiography To stop the time counter after finishing the study user need to switch to FA optics menu and press the STOP STUDY button IM 080 Rev A Page 11 of 16 TECHNICAL DESCRIPTION FUNDUS ANGIOGRAPHY MODULE CONNECTED TO THE PICTOR PLUS M5 CAMERA Type Pictor Plus FA Intended use Intended to capture digital images of the fundus angiograms of the human eye Illumination Infrared LED for targeting Blue LED for photographing 10 illumination brightness levels 9 red internal fixation target LEDs Maximum Luminance output 8 07 cd cm level towards eye Field of view 40 Diopter compensation 20 D to 20 D Image resolution 1536x1152 px total 1 8 Mpix informational area 1 41 Mpix Dimensions 160x73mm Weight 310g ENVIRONMENTAL CONDITIONS FOR USE STORAGE AND TRANSPORTATION IP Code IPXO Equipment not protected against the ingress of water Use environment Intended to be use indoors Temperature use 10 C to 35 C Relative humidity use 10 to 80 Atmospheric pressure 800 hPa to 1060 hPa NOTE EMC information given in Annex A Temperature storage 10 C to 40 C Relative humidity storage 10 to 95 Atmospheric pressure 500 hPa to 1060 hPa NOTE If stored over 1 month it is recommended to remove battery Transported in protective aluminium carrying case Temperature 40 C to 70 C Relative humidity 10 to
5. six tabs One is for device settings such as language selection There is one tab for retinal imaging RET fundus Preview images angiography FA anterior eye imaging ANT ear imaging OTO Now pation toktor skin imaging DER and general imaging DF Arrow keys are used to move between tabs use arrow key up Erase image memory until tab is active and use left and right arrow keys to change active tab Light blue color indicates active tab Select settings page with Arrow keys change values in the menu Active value is indicated s with light blue color Changed values are saved by using left soft rom Cancel key Ok and cancelled by pressing right soft key Cancel Some values are confirmed by pressing the Middle key Fluorescein Angiography Imaging Using Optic Modules VP2HAND amp VP2FA The Volk Optical FA digital ophthalmic camera is intended to capture digital images of the fundus angiography of the human eye The device set for fundus angiography imaging consists of e Pictor Plus handset VP2HAND e Attachable Pictor Plus FA module VP2FA e Eye cup for Pictor Plus VP2ECUP e Cradle for charging and image transfer VPCRADLE Infrared is used for targeting image to the eye fundus and blue light is flashed when image is taken Pupil does not respond to the infrared light so examination is convenient for the patient Pictor Plus FA has 9 internal fixation targets for the patient to fixate at while imaging B
6. ECTOR BAYONET HOLE OPTICS RELEASE BUTTON DUALACTION SHUTTER SNAP FOR OPENING SYSTEM BATTERY CONNECTOR COVER CONNECTION mmm LED RIGHT SOFT LEFTSOFTKEY MIDDLE KEY IM 080 Rev A Page 4 of 16 Soft key indicators Position Indicator Purpose To power on the device To power off the device with long press Left soft key Right soft key B Open menu with long press LED indicators The recharging and connection to PC is indicated with green charging and blue connection LED lights Position Indicator Purpose Active when device is powered on blinking when charging in Left LED indicator Green cradle Right LED indicator Blue Active when device is placed to the cradle and connected to a PC ATTACHING AND DETACHING OPTICS MODULE CAUTION Optic modules used with Volk Optical Pictor Plus must include text PICTOR PLUS or PICTOR It is not allowed to attach other objects to the bayonet connector BAYONET I al Optics are attached by placing it in front of the bayonet area of the device Three bayonet legs are placed on the holes and optics is pressed firmly to the device BAYONET HOLES Optics are released by sliding release button that is located in front of the device above the dual action shutter OPTICS RELEASE BUTTON IM 080 Rev A Page 5 of 16 DEVICE MENU Menu is opened by pressing right soft key ZX for 1s ee SRT OIO VERS YF k Menu has
7. Enter camera menu by pressing Right soft key for longer than 1s Long New patient folder If multiple patients are examined during a same session it is recommended to create a new file folder for each patient s Middle key images New folder is created by pressing middle key for 3 seconds Icon P at the top of the screen indicates number of the current patient folder If the current folder does not have any images in it a new folder cannot be created Focus manually When manual focus is active use up and down arrow keys to focus Press arrow key up when patient has myopia Press arrow key down when patient has hyperopia Select fixation target Move between 9 internal fixation targets Icon above left soft key turns to lighter color when fixation target selection mode is active Up Down arrow Change brightness Use left and right arrow keys to adjust capture light brightness Icon above left soft key must be selected lighter color to change brightness Left Right arrow Rig Select fixation target Move between 9 internal fixation targets Icon above left soft key turns to lighter color when fixation target selection mode is active IM 080 Rev A Page 8 of 16 Table below includes explanations of the FA settings tab for fundus Angiography imaging Setting Values default bolded Purpose Start Study This enables the study to start For every new study user needs to go into the menu and start study to enable the study or Time
8. PICTOR USER S MANUAL Volk Pictor Plus Fluorescein Angiography FA Module For Use with Volk Pictor Plus IM 080 Rev A Page 1 of 16 THIS SALES PACKAGE INCLUDES Model Description Fluorescein Angiography VP2FA Module for fundus fluorescein angiography imaging IM 080 User Manual QUICK START GUIDE WHAT TO DO BEFORE THE FIRST USE Remove Volk Optical Pictor Plus Fluorescein Angiography module from the sales package and check that all parts are undamaged NOTE For more detailed information on the use of the Pictor Plus Handset VP2HAND please consult Instructions for Use document IM 071 INDICATIONS FOR USE The Pictor Plus Fluorescein Angiography module VP2FA is a supported optics lens for the Pictor Plus Handset VP2HAND and is intended to capture digital images of the fundus angiograms of the human eye WARNINGS AND CAUTIONS Use only accessories and battery provided by Volk Optical with this product Place PC and cradle outside the patient environment at least 4 feet distance from the patient Connection between camera and workstation is USB and or WIFI Any authorization procedures should be carried out in workstation Images and videos can be copied from camera to workstation via USB and or WIFI and then viewed in workstation USB write protection is on by default When protection is on this feature will prevent writing to camera memory card from PC when connected to the cradle In case device has
9. WIFI functionality USB write protection must be turned off No modification of this equipment is allowed IM 080 Rev A Page 2 of 16 IMPORTANT SYMBOLS Symbol IM 080 Rev A Description The CE mark on this product indicates it has been tested and conforms to the provisions noted within the 93 42 EEC Medical Device Directive CE mark with notified body identification number indicates a class lla product Read accompanying user documentation indicates that important operating instructions are included in this User s and Maintenance Manual Failure to follow these instructions could place the patient or operator at risk Type BF applied parts Applied part is a part of Pictor Plus that in normal use necessarily comes into physical contact with the patient Used to highlight the fact that there are specific cautions associated with the device which are not otherwise found on the label Charger polarity symbol voltage and power The symbol indicating separate collection for Waste Electric and Electrical Equipment per Directive 2002 96 EC ME Equipment and ME SYSTEMS that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment shall be labelled with the symbol for non ionizing radiation Sticker at the front of the device indicating Volk Optical s address integrated general imaging optics focal length and F number Page 3 of 16 PARTS OF THE DEVICE BAYONET CONN
10. ally 2 to 8 Changing illumination brightness affects only the blue capturing flash Aim help square on the screen guides user when to take image When retina is not fully in view the square is red Once the aim is good and retina fully appears on screen the Square turn s green indicating a good moment for capturing the image Approaching the eye is started from 4 inches 10 centimetres distance Pupil is approached until the reflection from the eye fundus can be seen The right imaging distance is about 0 8 inch 2 cm Silicone support must be compressed approximately half way down Aim help square on the display guides to take image once it turns from red to green Camera is stabilised by keeping the outer side of the hand against the patient s forehead Example of the correct usage position is shown below Still image is captured by pressing the shutter key all the way down Video is captured by keeping shutter down Taken image is displayed on screen until user clears the image by pressing shutter left or right soft key Image can be zoomed in instant preview by pressing middle key There are four zoom levels Pressing middle key activates the next level Move around the image by using arrow keys This Instant Preview can be enabled disabled in the Pictor Plus FA optics menu If multiple patients are examined during one session new file folder is created for each patient by pressing middle key for over 3 seconds Transfer images to a PC
11. ates 1 800 345 8655 7893 Enterprise Drive Phone 440 942 6161 Mentor Ohio 44060 Fax 440 942 2257 USA Email volk volk com Website www volk com EU REPRESENTATIVE The Volk authorized representative based in the European Union EU is Keeler Limited Clewer Hill Road Windsor Berkshire SL4 4AA U K Tel 44 0 1753 857177 C s Note This product complies with current required standards for electromagnetic interferences and should not present problems to other equipment or be affected by other devices As a precaution avoid using this device in close proximity to other equipment Members of the European Union should contact their authorized Volk Distributor for disposal of this unit Standards Council of Canada Accredited Registrar 9 Conseil canadien des normes Registraire accredit Certificate FM 71461 Copyright 2014 Volk Optical Inc IM 080 Effective July 9 2014 Revision A IM 080 Rev A Page 16 of 16
12. d and put into service according to the EMC information provided Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL SYSTEM Pictor Plus should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the EQUIPMENT or SYSTEM should be observed to verify normal operation in the configuration in which it will be used Manufacturer s declaration electromagnetic immunity PICTOR PLUS is intended for use in the electromagnetic environment specified below The customer or the user of the Pictor Plus should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 Ur gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 Ur 30 dip in U for 25 cycles lt 5 Ur gt 95 dip in U for 5 sec 2kV 4kV 6 kV indirect contact 2kV 4kV 6 kV contact 2kV 4kV 8 kV air 2 kV for AC power supply 1 kV for serial cable 1 kV for AC power supply 1 Phase without Protective Earth Manufact
13. disturbances are controlled The customer or the user of the Volk Optical Pictor Plus can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Volk Optical Pictor Plus as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter Separation distance according to frequency of transmitter W m 150 kHz to 80 MHz 150 kHz to 80 MHz 800 MHz to 2 5 GHz d 1 2 yP d 1 2VP d 2 3VP For transmitters rated at a maximum output power not listed above the recommended separation distanced in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people IM 080 Rev A Page 15 of 16 OLK the leader in aspheric optics A HALMA COMPANY ORDERING INFORMATION Orders may be placed with the Authorized Volk Optical Distributor in your region Authorized Distributor contact information is available directly from Volk Optical Volk Optical Inc Toll free within the United St
14. elow section will guide how to control the fixation lights STEPS FOR RETINAL IMAGING 1 2 3 The examination room should be as dark as possible Both the patient and the examiner shall be seated while taking the images When using Pictor Plus FA optics the device should be mounted on a slit lamp base using Slit lamp Adapter its mandatory to achieve good images Either autofocus or manual focus can be used Autofocus range is 11 to 3 diopters manual focus range is 20 to 20 diopters If patient has a refractive error and autofocus is off focus need to be adjusted e Hyperopia camera is focused to distance by pressing arrow key up One click of the key is approximately 2 Diopters e Myopia camera is focused closer by pressing arrow key down One click of the key is approximately 2 Diopters Aiming light is automatically turned on when camera enters live view The middle fixation target is lit when pressing left soft key and it provides a macula centred image To change the fixation target press Left Soft Key and use arrow keys to navigate between the 9 targets as shown in the graphics in lower left corner of the display If fixation target is turned off ask patient to look at a target in a wall 6 9 feet 2 3 meters behind the operator IM 080 Rev A Page 6 of 16 10 11 12 13 Light is adjusted using left and right arrow key There are altogether 10 brightness levels Default value is 5 Suitable illumination is typic
15. ion in which the Pictor Plus is used exceeds the applicable RF compliance level above the Model 006 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Pictor Plus Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m IM 080 Rev A Page 14 of 16 Manufacturer s declaration electromagnetic emissions PICTOR PLUS is intended for use in the electromagnetic environment specified below The customer or the user of the Pictor Plus should assure that it is used in such an environment Compliance wq e Electromagnetic environment guidance Uses RF energy only for its internal function Therefore its RF RF emissions CISPR 11 Group 1 emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Harmonic emissions IEC 61000 Not Is suitable for use in all establishments including domestic 3 2 applicable establishments and those directly connected to the public low voltage Voltage fluctuations flicker power supply network that supplies buildings used for domestic purposes emissions Complies IEC 61000 3 3 Recommended separation distances between portable and mobile RF communications equipment and the Volk Optical Pictor Plus The Pictor Plus is intended for use in an electromagnetic environment in which radiated RF
16. o any part of the Pictor Plus including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 V Conducted RF oe d 1 2vP 150 kHz to IEC 61000 4 6 80 MHz d 1 2VP 80 MHz to 800 MHz d 2 3VP800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m 3 V m I Radiated RF Field strengths from fixed RF transmitters as determined by an 80 MHz to jet i I IEC 61000 4 3 gt 5 GHz electromagnetic site survey a should be less than the compliance level in i each frequency range Interference may occur in the vicinity of equipment marked with the following symbol i NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the locat
17. o help focus on the target light Calibration Frequency User can manually set calibration frequency of the optics For Example User selects 5 the device won t calibrate until next five consecutive images taken Camera stores selected menu settings when it is powered off IM 080 Rev A Page 9 of 16 Menu 1 Default Display window when FA optics is attached using Manual Mode You can adjust the Diopter scale according to patient diopter manually Image can be taken when shutter button held all the way down 2 op FA gt Optics recognized as FA for fundus angiography imaging 3 Default Display window when FA optics is attached using AF Assist mode Diopter scale is automatically adjusted Image can be captured when shutter button is pressed half a way 4 Default Display window when FA optics is attached using MF Assist mode Diopter scale is manually adjusted Image can be captured when shutter button is pressed half a way IM 080 Rev A Page 10 of 16 5 When Right Arrow key is held down all the way Menu table appears on display Default Device tab will be ON By using left and right arrow keys you slide to the next tab Here FA tab is chosen Time Counter Start study is selected from the FA optics menu After pressing shutter button half way for one time during the live view screen Time counter will appear on the upper right pointed with arrow on the image Time counter will be printed on the final images Time
18. urer s test shows conformance to the requirements of the IEC 61000 4 11 EN 61000 4 11 NOTE Ur is the a c mains voltage prior to application of the test level IM 080 Rev A Page 13 of 16 IEC 60601 test level Compliance Electromagnetic level environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Pictor Plus requires continued operation during power mains interruptions it is recommended that the Pictor Plus be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Guidance and manufacturer s declaration electromagnetic immunity The Pictor Plus is intended for use in the electromagnetic environment specified below The customer or the user of the Pictor Plus should assure that it is used in such an environment IEC 60601 Compliance Immunity test testlevel level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer t
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