Optomed Smartscope EY4, Smartscope M5, Smartscope PRO User Manual

USER’S MANUAL
Optomed Smartscope PRO
& Smartscope FA
Optomed SMARTSCOPE PRO & SMARTSCOPE FA are manufactured by
Optomed Ltd.
Place of Business:
Optomed Ltd
Yrttipellontie 1
FI-90230 Oulu
Finland
Manual version: Rev 17.0
Date: 2019 09 30
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This manual describes guidelines for the following modules:
Model:
Description:
Accessories
Smartscope M5
medical digital camera
Smartscope EY4
module for retinal imaging
Smartscope FA
module for fundus fluorescein angiography eye cup, quick user guide
imaging
Smartscope ES2
module for anterior ophthalmic imaging
Smartscope Cradle V1
for data transmission and battery charging
eye cup, quick user guide
USB cord
Power unit
If not all optics modules were purchased then the sales case does not include them or the accessories
related to that optics module.
In addition, the sales case includes:
- Batteries (2 pcs)
- Cleaning cloth
- User manual
- USB memory stick (Includes training material, Optomed Orbit software and user manual, and
Optomed Client PC software in case device has WLAN functionality).
The following accessories can be purchased separately:
- Optomed Slit Lamp Adapter that enables the camera to be used as stationary imaging tool.
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Quick start guide
WHAT TO DO BEFORE THE FIRST USE:
1. Remove Optomed Smartscope M5 from the sales
package and check that all parts are undamaged.
2. Install Battery as instructed in the Appendix B.
3. Place Cradle on a desk next to the PC (Personal
Computer).
4. Connect the USB cable to the PC.
5. Connect power unit to the wall plug (mains)
6. Place Optomed Smartscope M5 to the cradle. Battery
starts to charge. Charge battery for 4 hours before the
first use. When device is not used, it may be stored in
the Cradle.
7. Camera will not automatically power up in the cradle without the charger. User needs to press
the power button.
Guideline for placing the camera to the cradle:
Camera will fit to the cradle when it’s hold straight while placing it. Excessive force shall be
avoided in order to prevent the camera and cradle connectors from breaking.
Guideline for battery and device storage:
If battery is stored out of the camera for longer period of time, ensure that battery is fully
charged before storage. During storage battery shall be re-charged occasionally (e.g. every
3-9 months).
If battery is stored in the camera, camera shall be placed in the cradle with cradle power
cable connected.
Device is not allowed to be used when battery cover is open.
Normal battery life time is expected to be 1-2 years.
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Table of contents
Quick start guide ............................................................................................................................. 3
Table of contents............................................................................................................................. 4
1.
Indications for use ................................................................................................................ 5
2.
Contraindications for use of the optics modules EY4, FA and ES2 ...................................... 6
3.
Warnings and cautions ......................................................................................................... 7
4.
Important symbols ............................................................................................................... 8
5.
Parts of the device................................................................................................................ 9
6.
Usage environment requirements ..................................................................................... 12
7.
Operating instructions........................................................................................................ 13
7.1. Preparations ................................................................................................................... 13
7.2. Connection to a PC ......................................................................................................... 13
7.2.1. Pay-per-study .......................................................................................................... 13
7.3. Basic use – starting up, shutting down and taking an image ......................................... 14
7.3.1. Image quality analysis ............................................................................................. 14
7.4. Attaching and detaching optics module ......................................................................... 15
7.5. Device Menu ................................................................................................................... 15
7.6. Patient editor .................................................................................................................. 18
7.6.1. Adding new patient ................................................................................................. 18
7.6.2. Patient folder linking ............................................................................................... 19
7.6.3. Patient list exporting ............................................................................................... 19
7.7. Adjusting focus and automatic focus ............................................................................. 19
7.8. Reset button ................................................................................................................... 19
8.
Retinal imaging using optics module Smartscope EY4 ...................................................... 20
9.
Eye imaging using anterior ophthalmic module Smartscope ES2 ..................................... 25
10. Fluorescein Angiography imaging using optics module Smartscope FA ............................ 29
11. Error messages ................................................................................................................... 34
12. Cleaning instructions .......................................................................................................... 35
13. Device maintenance ........................................................................................................... 36
14. Technical description ......................................................................................................... 37
15. Warranty ............................................................................................................................ 42
Appendix A - Electromagnetic compatibility information ............................................................ 43
Appendix B - Replacing the battery............................................................................................... 46
Appendix C - WLAN functionality .................................................................................................. 47
Installing / Uninstalling.............................................................................................................. 47
Operation .................................................................................................................................. 47
WLAN SD card firmware update ............................................................................................... 50
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1. Indications for use
Smartscope M5 is a medical digital camera that is used with dedicated optics lens intended to take images
of the eye fundus and surface of the eye.
Supported optics lenses and their intended uses are:
Model:
Description:
Smartscope EY4
Optomed Smartscope M5 digital camera with EY4 optics module is
intended to capture digital images and video of the fundus of the
human eye.
Smartscope FA
Optomed Smartscope M5 digital camera with FA optics module is
intended to capture digital images of the fundus angiograms of the
human eye.
Smartscope ES2
Optomed Smartscope M5 digital camera with ES2 optics module is
intended to capture images and video of the surface of the human eye
and surrounding areas.
The device may only be operated by persons who have been properly trained or who have the required
knowledge and experience to do so.
Smartscope M5 with optics modules is a prescription device: Federal law restricts this device to sale by or
on the order of a physician or licensed practitioner.
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2. Contraindications for use of the optics modules EY4, FA and ES2
Because prolonged intense light exposure can damage the retina, the use of the device for ocular
examination should not be unnecessarily prolonged, and the brightness setting should not exceed what
is needed to provide clear visualization of the target structures.
The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time.
If the value of radiance were reduced in half, twice the time would be needed to reach the maximum
exposure limit.
While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is
recommended that the intensity of light directed into the patient's eye be limited to the minimum level
which is necessary for diagnosis. Infants and persons with aphakia or diseased eyes will be at greater risk.
The risk may also be increased if the person being examined has had any exposure with the same
instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours.
This will apply particularly if the eye has been exposed to retinal photography.
Smartscope EY4, FA and ES2 are classified as Group 2 based on standard ISO 15004-2:2007. The daily
usage time and maximum allowed number of pulses is calculated based on optical classification results
according to standard ISO 15004-2:2007.
WARNING:
The light emitted from this instrument is potentially hazardous. The longer the
duration of exposure and the greater the number of pulses, the greater the risk of
ocular damage. Exposure to light from this instrument when operated at maximum
output will exceed the safety guideline after:
Maximum number of pulses (still images) allowed daily:
-
EY4: 6300 pulses (still images) / eye
-
FA: 5000 pulses (still images) / eye
-
ES2: 250 pulses (still images) / eye
Or alternatively
Total daily usage time for continuous light (= video usage time + aiming light duration)
shall be limited to:
-
EY4: 1 h 30 min video usage / eye
-
ES2: 8 min video usage / eye
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3. Warnings and cautions
Place PC and cradle outside the patient environment (at least 1.5 meters distance from the
patient).
Use only accessories and battery provided by Optomed with this product.
Connection between camera and workstation is USB and/or WLAN. Any authorization
procedures should be carried out in workstation.
Images and videos can be copied from camera to workstation via USB and/or WLAN 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
WLAN functionality, USB write protection must be turned off.
USB connection works without power cable. There is no USB charging in M5
No modification of this equipment is allowed.
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4. Important symbols
Symbol
Description
European certificate of conformity
CE marking with notified body identification numbering indicates
the conformity of 93/42/EEC Medical Device Directive for class IIa
devices and CE marking without notified body identification
numbering indicates the conformity of 93/42/EEC Medical Device
Directive for class I devices.
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 Smartscope that in normal use necessarily
comes into physical contact with the patient.
Charger polarity symbol, voltage and power
9 V, 1.1 A
Interference may occur in the vicinity of equipment (in case device
has WLAN functionality).
Prepare the device for reuse or separate collection as specified by
Directive 2002/96/EC of the European Parliament and Council of the
European Union on Waste Electronic and Electrical Equipment
(WEEE). If this product is contaminated, this directive does not
apply.
WARNING
Indicates a hazardous situation which could result in patient injury,
harm or death if the appropriate safety precautions are not
followed.
CAUTION
Indicates a situation which could result in device harm, damage or
mal-function if the appropriate cautions / precautions are not
followed.
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5. Parts of the device
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Cradle:
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Soft key indicators:
Position
Indicator
Left soft key
Purpose
To power on the device
To power off the device, with long press
Right soft key
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
Left LED-indicator
Green
Active when device is powered on, blinking when charging in
cradle.
Right LED-indicator Blue
Active when devices is placed to the cradle and connected to a
PC.
Graphical indicators:
These indicators are displayed on the top row of the display during imaging:
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6. Usage environment requirements
WARNING
Smartscope is not suitable for use in the presence of flammable anesthetics.
WARNING
Place PC and cradle outside the patient environment (at least 1.5 meters distance from
the patient).
CAUTION
Smartscope is intended to be used inside in a normal room temperature and normal
humidity. Do not use Smartscope in an environment where there is possibility that
water condenses to or inside the Smartscope.
CAUTION
If the PC is connected to a customer network make sure to apply appropriate safety
measures, such as Antivirus and Firewall protection.
CAUTION
It is only allowed to attach USB cable and Power source provided in the sales package
into the cradle. If you need replacement to the USB cable or Power source please
contact Manufacturer or your own Retailer.
USB Cable must be connected only to the USB port of a PC computer that complies
with the IEC 60950 standard. Avoid using excessive power or twisting the connector
when connecting the USB cord to a PC.
To transfer patient image data the device must be used together with a PC (Personal Computer) running
either Microsoft Windows 7®, Windows 8.1® and Windows 10®. The device does not need any drivers to
be installed on a PC.
Writing to the memory card from PC is not enabled by default.
Device shall be used according to this manual, quick reference guide and / or information found on
Optomed website www.optomed.com.
Electromagnetic compatibility information and recommended separation distances between portable
and mobile RF communications equipment and the Optomed Smartscope are given in the Appendix A.
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7. Operating instructions
This chapter gives instructions for using the device. More specific instructions for using optics lenses are
given in the optics lens specific chapters.
7.1. Preparations
Smartscope is both charged and connected to PC (Personal Computer) using the provided cradle. When
Smartscope is not used, it may be stored in the cradle. Storing device in the cradle is not harmful for the
battery.
Device can be connected to the cradle with optics attached.
7.2. Connection to a PC
Image data transfer method to PC is similar as with a digital camera.
When connected to a PC running Microsoft Windows 7®, Windows 8.1®
or Windows 10® operating system displays query for AutoPlay. It is
possible to select appropriate image viewing program or simply open
the folder to view and then store files to the hard disk of the PC.
Writing to the memory card from PC is not enabled by default.
In case device has WLAN functionality, USB write protection must be turned off. WLAN enables wireless
image transfer from camera to PC. Image transmission system is shown below:
Instructions how to establish WLAN connection with Optomed Client refer to Appendix C.
7.2.1.
Pay-per-study
In case camera is in pay-per-study mode, images can be viewed only with Optomed Workstation Software.
There are no other changes in camera functionality.
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7.3. Basic use – starting up, shutting down and taking an image
Device is powered on by pressing left soft key.
It is possible to capture both still images and video. Image capture mode is changed from camera menu
(optics specific tab) that opens by pressing right soft key for 1s.
Still image is captured using the dual action shutter to the second position. Video is captured by keeping
the dual action shutter pressed down in the second position.
Taken image will stay on display until it is cleared by pressing right or left 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.
To transfer images to a PC via USB connection, place device to the cradle. The image transfer and charging
is indicated with green and blue LED-lights and text on LCD-screen. In case the WLAN connection is active
images are transferred to the PC automatically.
NOTE:
If images are corrupted or not transferred to the PC, the original images are saved to the
memory card. Please try again to transfer images to the PC via USB.
Smartscope verifies if image data is erased either when device is powered on from power off mode or
power save mode or when device is removed from the cradle. It is recommended that image data storage
is always erased with a new patient.
Device is powered off by keeping left soft key pressed down over 1 second.
NOTE:
When device is powered on, powered off or goes to standby mode the camera focus motor
may make a sound. This sound is normal and is not a sign of any damage or problem.
7.3.1.
Image quality analysis
After capturing an image, the image quality analysis is performed if image quality analysis is enabled from
optics menu. The results of image quality analysis are shown in instant review with the image. Letter B
represents the brightness of the image. If the brightness of the image is good, the indicator is shown as
green. The indicator is shown as yellow, if the image is little bit over or under exposed. If the image is
severely over or under exposed the indicator is shown as red.
Letter R represents reflections and shadowing. If the image
has no reflections or shadowing, the indicator is shown as
green. The indicator is shown as yellow, if the image has small
reflections or shadows. If the image has large reflections or
shadows, the light is red.
Letter S represents sharpness. If the image is sharp, the
sharpness value is green. The indicator is yellow, if the image
is not sharp enough. For un-sharp image, the indicator light is
shown as red.
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7.4. Attaching and detaching optics module
NOTE:
Optic modules used with Optomed Smartscope M5 must include text “SMARTSCOPE”. It is
not allowed to attach other objects to the bayonet connector.
Optics is 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:
Optics is released by sliding release button that is located in front of the device above the dual action
shutter:
7.5. Device Menu
Menu is opened by pressing right soft key
for 1s.
Menu has different tabs. One is for device settings such as
language selection. There is one tab for retinal imaging (EY),
fundus angiogram imaging (FA) and anterior eye imaging
(ES).
Arrow keys are used to move between tabs: use arrow key
up until tab is active and use left and right arrow keys to
change active tab. Light blue color indicates active tab.
Arrow keys change values in the menu. Active value is indicated with light blue color. Changed values
are saved by using left soft key (“Ok”) and cancelled by pressing right soft key (“Cancel”). Some values
are confirmed by pressing the Middle key.
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Table below includes explanations of the Device settings tab:
Setting
Values (default bolded)
Purpose
Preview images
Ok
To preview the images on camera press middle button.
New patient folder
Ok
To create a new patient folder press middle button. New
patient folder can also be created in live view by long
pressing the middle key.
Erase image memory
Ok
Select middle button to erase images and videos from
camera SD card.
Edit patient list
Ok
Press middle key to edit patient list
Patient information
On/Off
Enable or disable patient information linking
Display brightness
Low-Med-High
Use left and right arrow keys to adjust display brightness
Icons
On/Off
Show graphical icons when imaging.
Sounds
On/Off
When enabled, sound is played during image capture
Keyboard backlight
On/Off
When enabled, keyboard illumination is on
Select language
ENG-FIN-FRA-GER-ITAJPN-POR-SPA-ZHO
Use left and right arrow keys to select camera language
USB write protection
On/Off
When enabled, writing to SD card is not allowed when
device is in cradle. This feature helps prevent any viruses
getting from PC to the camera. Note that if device contains
WLAN card, during its setup or updating of its firmware,
USB write protection need to be temporarily set off.
Video file format
MPEG4/MPEG1
Use left and right arrow keys to select video file format
Image transfer
method
UMS/WIA
Use WIA for automatic and UMS for end-user activated
image transfer. UMS can be used in most cases.
Restore factory
Setting
Ok
To restore all settings menus to factory defaults. Activate
using the middle key. Note that also Wireless password is
restored to default.
SD card firmware
update mode
Ok
To start SD card firmware update mode, press middle
button.
Date
DD-MM-YYYY
Use up and down arrow keys to set date.
Time
HH:MM
Use up and down arrow keys to set time.
Camera SW version
Show camera SW version
Browse version information with left and right arrow key
Start query
Era./Fol./None
Choose the startup query between memory erase, new
patient folder or no query at all.
Wireless
On/Off
Enable or disable wireless connection
Wireless info
Ok
To view ‘WLAN SSID’ and ‘WLAN Password’, press middle
button.
Preview images
Image preview is opened by selecting “Preview files” with a middle key. Images are browsed by using
arrow keys. Display gives information about usage of the image preview.
Image can be zoomed while previewing by pressing middle key. Move around the image by pressing arrow
keys. Change between the four zoom levels by pressing middle key.
Patient ID information can be edited in image browser.
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New Patient Folder
A new patient folder is created by pressing middle key when the new patient folder selection is active in
Device menu. A new patient folder can also be created by pressing Middle key for 3 seconds when in live
view. If the current patient folder is empty a new folder cannot be created.
Erase Image Memory
Image memory can be erased by selecting “Erase Image Memory” in Device menu. This selection is
activated by pressing middle key. The camera also prompts the question “Erase image memory?” when
camera is powered on or removed from cradle.
Edit patient list
User can add or remove patients from patient list.
Patient information
Enable or disable patient information linking.
Display brightness
The Display brightness selection has three options: low, medium and high. Choose the suitable level of
display brightness according to for example how the examination room is lit up.
Icons
The icons shown on camera screen can be enabled or disabled to the user’s liking. The most essential
icons such as Menu icon are always visible.
Sounds
By default the camera makes a sound during image capture. This sound can be turned off from Device
menu.
Keyboard backlight
By default the camera keys have a backlight lit up when the camera is turned on. This light can be turned
off from Device menu if it disturbs the user while taking images.
Language
Camera has nine (9) different languages the user can choose from. Default language is English and the
language selection is always shown in English in menu. If language is changed camera has to be re-started.
USB write protection
USB write protection is on by default. When protection is on this feature will prevent any virus from
entering the camera from a PC when connected to the cradle. In case device has WLAN functionality, USB
write protection must be turned off.
Video file format
Camera has two file formats that user can choose for videos: MPEG4 and MPEG1. MPEG4 is a higher
quality file format but may not be viewed with all video players. MPEG1 format is more widely supported
by different SW applications.
Image transfer method
There are three options for the image transfer method: UMS (USB Mass Storage), WIA (Windows Image
Acquisition) and WLAN.
NOTE: WLAN supported only if device has WLAN functionality.
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Restore factory settings
Press middle key to restore factory defaults selection. Note that also Wireless password is restored to
default.
SD card firmware update mode
In case the device has WLAN functionality, SD card firmware can be updated by pressing middle button.
The device must be placed on cradle for SD card firmware update. If PC prompts a message to insert the
SD card, press any camera key to continue update. For more specific instructions, see Appendix C.
Date
Press middle key to change date settings. Date can be set using the up and down arrow keys. Move
between day, month and year by pressing the left and right keys. Date format is DD MM YYYY for Finnish,
German, French, Italian, Spanish and Portuguese. Date format is MM DD YYYY for Japanese and Chinese.
Time
Press middle key to change time settings. Time can be set using the up and down arrow keys. Move
between hours and minutes by pressing the left and right arrow keys.
Camera SW version
This item in Device menu tells the camera SW version.
Start query
User can choose start-up query between erasing images, creating new patient folder or no query at all.
When erasing images is chosen as the query the camera will prompt user on start-up whether all images
and videos shall be deleted. When new patient folder query is chosen the camera will ask if a new patient
folder shall be created upon start-up to prevent from mixing images with previous patient. If no query is
selected then camera will go directly to live view upon start-up.
Wireless
By default, wireless connection is on. User can enable or disable wireless connection. When wireless
connection is enabled, the wireless symbol is shown on display next to the battery level indicator.
Wireless info
Press middle key to view wireless connection information. ‘WLAN SSID’ and ‘WLAN Password’ are shown.
7.6. Patient editor
Patient information usage can be enabled / disabled. There can be maximum 500 patients on the list.
Name of the patient is shown in low right hand side above right soft key, if current folder is linked to a
patient.
7.6.1.
Adding new patient
User can add new patient from Device menu by selecting Edit Patient list. User can add Patient ID and
Patient name after choosing New patient. New patient can be added also after creating new folder.
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7.6.2.
Patient folder linking
User can link or unlink patient to/from current folder (not earlier ones). It is possible to link 5 folders to
each patient.
Linking can be done:
1. After erasing image memory, choose ‘yes’ when camera asks to ‘choose patient for the folder’.
2. Choosing Link in image browser, when folders and files are visible. Link key is grey and
unresponsive if current folder is not chosen. After folder is linked to a patient, folder is named by
the patient.
3. After creating new folder by long pressing middle key or from menu, choose ‘yes’ when camera
asks to ‘choose patient for the folder’.
NOTE: Exiting from image browser is done by pressing left key.
7.6.3.
Patient list exporting
User can export patient list via WLAN. New file is created containing patient list with 16 kBytes of padding
bytes added to the end of file. File is named pehhmmss.jpg (hh is current hours, mm minutes and ss
seconds). File is written under DCIM folder in SD card. File is exported over WLAN.
Patient list can be exported also via USB. Patient list is written as text file (patexp.txt) to SD card root. If
patient list is modified in camera (new patient created) or SD card is erased, patient list is updated.
7.7. Adjusting focus and automatic focus
Camera has an autofocus function where camera finds correct focus place automatically. For EY4 and FA
square indicator appears when focusing is finished. For ES2 focus window turns green when focusing is
finished. Automatic focusing start when shutter button is pressed half way down. Focus mode can be
changed by pressing right soft key.
Image focus can be adjusted manually by pressing arrow keys up and down. When focus mode is set to
manual a diopter scale is visible on the screen.
7.8. Reset button
Reset button can be used if device behavior is abnormal.
Reset button is located in a small opening under display.
Button is marked with circle.
Reset button can be pressed with a thin object such as a paper clip.
Button needs to be pressed for over 7 seconds.
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8. Retinal imaging using optics module Smartscope EY4
Optomed Smartscope EY4 digital ophthalmic camera is intended to capture digital images and video of
the fundus of the human eye. The device set for retinal imaging consists of:
• Camera handset M5
• Attachable ophthalmic lens EY4
• Eye cup for EY4
• Cradle for charging and image transfer
Smartscope EY4 is intended for non-mydriatic imaging. This means that infrared is used for targeting
image to the eye fundus and visible light is flashed when image is taken. Pupil does not respond to the
infrared light so examination is convenient for the patient. Constant illumination can be selected from
device menu if mydriatic drops are used. Pictures can also be taken using infrared light for both aiming
and capturing.
Smartscope EY4 has 9 internal fixation targets for the patient to fixate at while imaging. Below section will
guide how to control the fixation lights.
STEPS FOR RETINAL IMAGING:
1. The examination room should be as dark as possible.
2. Both the patient and the examiner shall be seated while taking the images.
3. Either autofocus or manual focus can be used. Autofocus range is -15 to +10 diopters.
If patient has a refractive error and autofocus is off, focus need to be adjusted:
• Hyperopia: camera is focused to distance by pressing arrow key up. One click of the key is
approximately 1 Diopter.
• Myopia: camera is focused closer by pressing arrow key down. One click of the key is
approximately 1 Diopter.
4. Aiming light is automatically turned on when camera enters live view.
5. Middle fixation target is lit when pressing left soft key and it provides a macula centered 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 2-3 meters behind the operator.
6. Capturing light is adjusted using left and right arrow key. There are brightness levels from 0 to 10,
default value is 5, and typical levels are from 2 to 8. There are also low brightness levels 0.2, 0.4, 0.6
and 0.8 if brightness level 1 is too bright.
When using IR/White capture mode changing illumination brightness affects only the white capturing
flash. If using IR/IR or White/White both aiming and capturing light are changed.
7. Aim help circle on the screen guides user when to take image. When retina is not fully in view the
circle is red. Once the aim is good and retina fully appears on screen the circle turns green indicating
a good moment for capturing the image.
8. Approaching the eye is started from 10 centimeters (4 inch) distance. If internal fixation target is not
used patient is asked to look at a target in a wall 2-3 meters behind the operator (patient’s eye targets
to infinity and stays still). Pupil is approached until the reflection from the eye fundus can be seen.
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The right imaging distance is about 2 cm (0.8 inch). Eye cup must be compressed approximately half
way down. Aim help circle on the display guides to take image once it turns from red to green.
Camera is stabilized by keeping the outer side of the hand against the patient’s forehead. Example of
the correct usage position is shown below:
9. Still image is captured by pressing the shutter button all the way down. If half-press capture is
enabled, still image can be captured by pressing shutter button halfway down. Taken image is
displayed on screen until user clears the image by pressing shutter button, left or right soft key.
Instant review can be enabled/ disabled in the Smartscope EY4 optics menu.
10. Image can be zoomed in instant preview by pressing middle key. There are four zoom levels (1, 2, 4,
8). Pressing middle key activates the next level. Move around the image by using arrow keys. Scroll
between images by using left and right arrow keys.
11. Video is captured by keeping shutter button down. If half-press capture is enabled, video image can
be captured by pressing shutter button halfway down. Video capturing is finished by pressing shutter
button all the way down.
12. If multiple patients are examined during one session, new file folder is created for each patient by
pressing middle key for over 3 seconds.
13. Transfer images to a PC after capturing images. Images are transferred via USB connection to the PC
when camera is placed to the cradle or images are automatically transferred wirelessly to the PC if
WLAN connection is active. Smartscope works as any other digital camera.
14. To erase the image/video manually, choose Menu, then Preview Images. There will be an option to
erase a specific image or a specific folder.
15. 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.
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Camera keys function as shown in image below when Smartscope EY4 optics module is attached:
Table below provides explanations for the key functions:
Key
Press
Function
Explanation
Short
Control Fixation target
level and selection
Fixation target is off by default and can be turned on
by pressing left soft key. Fixation target light has two
levels: Low and High. If 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 / AF
assist
Switch between focus modes by pressing Right soft
key. Manual focus is on by default. Autofocus range is
-15 to +10 diopters.
Long
Open Menu
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 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.
-
Change brightness
Use left and right arrow keys to adjust capture light
brightness. Icon above right soft key must be selected
to change brightness.
Move fixation target
Move between 9 internal fixation targets. Icon above
left soft key turns to lighter color when fixation target
selection mode is active.
Focus manually
When manual focus is active use up and down arrow
keys to focus. Press arrow key up when patient has
hyperopia. Press arrow key down when patient has
myopia.
Move fixation target
Move between 9 internal fixation targets. Icon above
left soft key turns to lighter color when fixation target
selection mode is active.
Left soft key
Right soft key
Middle key
Left/Right arrow
-
Up/Down arrow
Page 22 of 51
Table below includes explanations of the EY settings tab for retinal imaging:
Setting
Values (default bolded)
Purpose
Capture mode
Still / Video
Use left and right arrow keys to move between still capture
and video capture.
Half press capture
On/Off
Enable capture by pressing shutter button half way.
Mark side
On/Off
Mark side of the eye to the image data.
Red-free
On/Off
Saves a copy of an eye image using green color channel
only.
Save IR image
On/Off
Saves an image taken with IR light in addition to white light
image when turned on.
Low red
On/Off
Capture red reduced copy in addition to normal fundus
image.
Illumination mode
IR/Wh, IR/IR, Wh/Wh
Use left and right arrow keys to select aiming and capture
light source.
Automatic IR contrast
On/Off
Enable automatic IR contrast
Target blinking
On / Off
Fixation target light can be set to constant if needed.
Capture setting in
image
On/Off
Enable or disable writing of capture settings to image.
Instant Review
On/Off
Instant review can be ON/OFF according to user need, as
available in EY Optics menu. Instant review image can be
changed from left and right arrow keys.
Image quality analysis
On/Off
Enable or disable the image quality analysis after image
capture.
Capture mode
Both still images and video can be taken with the Smartscope M5 camera. When taking video the shutter
button must be held down while taking the video. The video recording will stop once the shutter button
is released.
Half-press capture
It is possible to take images and video by pressing shutter button halfway down.
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.
Save Red-free
If red-free image is enabled from menu, then camera will save a picture using only green channel at the
same time when saving original picture.
Save IR image
If Save IR image is enabled from menu the camera will save an image taken with IR image in addition to
saving a color image taken with white light.
Page 23 of 51
Low red
It is possible to capture red reduced image.
Illumination mode
Illumination mode can be set to IR/White, IR/IR or White/White. In IR/White mode aiming is done using
infrared light and image is captured using white light. The pupil does not react to infrared light and thus
it is recommended to use IR/White mode whenever possible. In IR/IR mode both aiming and image
capture are done with infrared light. In White/White mode aiming and image capture are done with white
light.
Automatic IR contrast
Automatically adjust infrared live view brightness and contrast according to image content. Improves
visibility of fundus features during aiming. Same contrast and brightness settings are applied to IR still
captures.
NOTE: In IR/IR mode, IR brightness adjustment does not always directly affect brightness on screen when
automatic contrast is enabled. This happens because automatic contrast feature always tries to adjust
screen brightness to same level. IR brightness setting still works, but the effect is only visible when
adjustment range of automatic contrast adjustment runs out. It is advisable to use highest brightness that
does not cause image saturation (pink or white “washed out” effect).”
Target blinking
By default the fixation target light is on with blinking illumination. If patient cannot keep their eye targeted
well the light can changed to constant to help focus on the target light.
Capture setting in image
It is possible to write brightness and diopter settings to image.
Instant review
Instant review can be ON/OFF according to user need, as available in EY Optics menu. When the reviewing
zoom level is 1x, user can change the image to be reviewed with left and right arrow keys. Images are in
showing order Normal, Low-red, Red-free, IR.
NOTE: Camera stores selected menu settings when it is powered off.
Image quality analysis
When image quality analysis is turned on, the camera analyses the taken image and shows the results
related to brightness, reflection and shadowing, and image sharpness.
Page 24 of 51
9. Eye imaging using anterior ophthalmic module Smartscope ES2
Optomed Smartscope ES2 is intended to capture images and video of the surface of the human eye and
surrounding areas. The device set for anterior ophthalmic imaging consists of:
• Camera handset M5
• Attachable anterior ophthalmic lens ES2
• Cradle for charging and image transfer
Smartscope ES2 optics module has two light sources, white and cobalt blue light. User can choose
between the light sources by pressing middle key when ES2 module is attached. Cobalt blue light enables
taking fluorescent pictures of the surface of the eye to reveal any cuts or defects.
STEPS FOR EYE SURFACE IMAGING:
1. After ES2 optics module is attached the light source is chosen by pressing middle key.
2. Still or video image is selected. Selection is made in ES menu.
3. It is recommended to use autofocus.
4. Aiming light is turned on by pressing the shutter key (in front of the device) halfway down.
5. Light is adjusted using left and right arrow key. There are altogether 10 brightness levels. Default value
is 5. Suitable illumination is typically 2 to 8.
6. Place the optics module cup on patient’s eye. Patient can be asked to look at different directions
depending on what area of the eye needs to be captured.
Camera is stabilized by keeping the outer side of the hand against the patient’s forehead. Example of
the correct usage position is shown below:
7. Still image is captured by pressing the shutter key all the way down. If half-press capture is enabled,
still image can be captured by pressing shutter button halfway down. Taken image is displayed on
screen until user clears the image by pressing shutter button, left or right soft key.
Instant review can be enabled/ disabled in the Smartscope ES2 optics menu.
8. Image can be zoomed in instant preview by pressing middle key. There are four zoom levels (1, 2, 4,
8). Pressing middle key activates the next level. Move around the image by using arrow keys. Scroll
between images by using left and right arrow keys.
9. Video is captured by keeping shutter button down. If half press-capture is enabled, video image can
be captured by pressing shutter button halfway down. Video capturing is finished by pressing shutter
button all the way down.
Page 25 of 51
10. If multiple patients are examined during one session, new file folder is created for each patient by
pressing middle key for over 3 seconds.
16. Transfer images to a PC after capturing images. Images are transferred via USB connection to the PC
when camera is placed to the cradle or images are automatically transferred wirelessly to the PC if
WLAN connection is active. Smartscope works as any other digital camera.
11. Erase manually image / video by choosing Menu – Preview images. There can be chosen either the
specific image or the specific folder to be erased.
12. 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.
Camera keys function as shown in image below when ES2 optics module is attached:
Page 26 of 51
Table below provides explanations for the key functions:
Key
Press
Function
Explanation
Short
Edit focus window/
Activate Zoom
When focus window is visible it is possible to move it
using arrow keys to better capture the wanted area.
Digital zoom can be used for close up of features and
image focus. Zoom value is saved to camera memory.
Long
Power On / Off
Camera is powered on and off by pressing the Left
soft key for longer than 2s.
Short
Auto / Manual focus /
Activate Zoom
Switch between Auto and Manual focus by pressing
Right soft key. Press Right soft key to activate zoom
function. Digital zoom can be used for close up of
features and image focus. Zoom value is saved to
camera memory.
Long
Open Menu
Enter camera menu by pressing Right soft key for
longer than 1s.
Short
White / Blue
Choose between white and blue illumination by
pressing left soft key. Blue light can be used with
fluorescent applied on the eye to reveal any cuts or
defects.
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 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.
-
Change brightness
Use left and right arrow keys to adjust capture light
brightness.
-
Move AF window
Move focus window left and right after pressing
Middle key to activate. Window returns to original
position when camera is put to cradle, turned off or
optics module detached.
-
Focus manually
Use up and down arrows to focus manually.
Zoom In / Out
Zoom in using arrow key up. Zoom out using arrow
key down. There are four zoom levels: 1, 2, 4 and 6.
Zoom value is saved to camera memory.
Move AF window
Move focus window left and right after pressing
Middle key to activate.
Left soft key
Right soft key
Middle key
Left/Right arrow
Up/Down arrow
-
Page 27 of 51
Table below includes explanations of the ES settings tab for anterior eye imaging:
Setting
Values (default bolded)
Purpose
Capture mode
Still / Video
Use left and right arrow keys to choose between still
capture and video capture.
Half press capture
On/Off
Enable capture by pressing shutter button half way.
Focus windows
Visible/Hidden
Use left and right arrow keys to choose between having
focus window visible or hidden.
Mark side
On/Off
Mark side of the eye to the image data.
Zoom cropping
On/Off
When turned on camera will save the zoomed area only.
When turned off camera will save the whole image area
even when zoom is used.
Instant Review
On/Off
Instant review can be ON/OFF according to user need, as
available in ES Optics menu. Instant review image can be
changed from left and right arrow keys.
Capture mode
Both still images and video can be taken with the Smartscope M5 camera. When taking video the shutter
button must be held down while taking the video. The video recording will stop once the shutter button
is released.
Half-press capture
It is possible to take images and video by pressing shutter button halfway down.
Focus Window
Focus Window helps user position the image. Focus Window can be moved on the screen by using Left
soft key and then using the arrow keys when aiming.
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 normal eye images are OS for left and OD for right.
- Identifiers used for red-free images are SG for left and DG for right.
- Identifiers used for save IR images are SI for left and DI for right.
- Identifiers used for low-red images are SC for left and DC for right.
Zoom cropping
With zoom cropping on the camera will save the zoomed area instead of the whole image area. By default
zoom cropping is turned off and camera will save the whole image area instead of the area that is visible
on the camera screen when user has zoomed in.
Instant review
Instant review can be ON/OFF according to user need, as available in ES Optics menu. When the reviewing
zoom level is 1x, user can change the image to be reviewed with left and right arrow keys. Images are in
showing order Normal, Low-red, Red-free, IR.
NOTE: Camera stores selected menu settings when it is powered off.
Page 28 of 51
10. Fluorescein Angiography imaging using optics module Smartscope FA
Optomed Smartscope 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:
• Camera handset M5
• Attachable Smartscope FA
• Eye cup for FA
• Cradle for charging and image transfer
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.
Smartscope FA has 9 internal fixation targets for the patient to fixate at while imaging. Below section will
guide how to control the fixation lights.
STEPS FOR RETINAL IMAGING:
1. The examination room should be as dark as possible.
2. Both the patient and the examiner shall be seated while taking the images.
3. When using Smartscope FA optics it is recommend to mount the device on a slit lamp base using Slit
lamp Adapter to achieve good images.
4. Either autofocus or manual focus can be used. Autofocus range is -11 to +3 diopters.
If patient has a refractive error and autofocus is off, focus need to be adjusted:
•
Hyperopia: camera is focused to distance by pressing arrow key up. One click of the key is
approximately 2 Diopters.
•
Myopia: camera is focused closer by pressing arrow key down. One click of the key is
approximately 2 Diopters.
5. Aiming light is automatically turned on when camera enters live view.
6. The middle fixation target is lit when pressing left soft key and it provides a macula centered 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 2-3 meters behind the operator.
7. Light is adjusted using left and right arrow key. There are altogether 10 brightness levels. Default value
is 5. Suitable illumination is typically 2 to 8. Changing illumination brightness affects only the blue
capturing flash.
8. 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.
9. Approaching the eye is started from 10 centimeters (4 inch) distance. Pupil is approached until the
reflection from the eye fundus can be seen. The right imaging distance is about 2 cm (0.8 inch). Eye
cup must be compressed approximately halfway down. Aim help square on the display guides to take
image once it turns from red to green.
Page 29 of 51
Camera is stabilized by keeping the outer side of the hand against the patient’s forehead. Example of
the correct usage position is shown below:
10. Still image is captured by pressing the shutter button halfway down. If half-press capture is enabled,
still image can be captured by pressing shutter button halfway down. Taken image is displayed on
screen until user clears the image by pressing shutter button, left or right soft key.
Instant review can be enabled/ disabled in the Smartscope FA optics menu.
11. Image can be zoomed in instant preview by pressing middle key. There are four zoom levels (1, 2, 4,
8). Pressing middle key activates next level. Move around the image by using arrow keys. Scroll
between images by using left and right arrow keys.
12. Starting and ending the burst capturing: In order to start the burst capturing keep the shutter
button pressed halfway or all the way down during image capturing. Burst mode is enabled until
user releases shutter button.
13. If multiple patients are examined during one session, new file folder is created for each patient by
pressing middle key for over 3 seconds.
14. Transfer images to a PC after capturing images. Images are transferred via USB connection to the PC
when camera is placed to the cradle or images are automatically transferred wirelessly to the PC if
WLAN connection is active. Smartscope works as any other digital camera.
15. When camera is removed from 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.
Page 30 of 51
Camera keys function as shown in image below when Smartscope FA optics module is attached:
Table below provides explanations for the key functions:
Key
Press
Function
Explanation
Short
Control Fixation target
level and selection
Fixation target is off by default and can be turned on
by pressing left soft key. Fixation target light has two
levels: Low and High. If 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
Auto / Manual / AF /
MF assist
Switch between focus modes by pressing Right soft
key. Manual focus is on by default. Autofocus range is
-11 to +3 diopters.
Long
Open Menu
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 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.
-
Change brightness
Use left and right arrow keys to adjust capture light
brightness. Icon above right soft key must be selected
(lighter color) to change brightness.
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.
Focus manually
When manual focus is active use up and down arrow
keys to focus. Press arrow key up when patient has
hyperopia. Press arrow key down when patient has
myopia.
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.
Left soft key
Right soft key
Middle key
Left/Right arrow
-
Up/Down arrow
Page 31 of 51
Table below includes explanations of the FA settings tab for fundus Angiography imaging:
Setting
Values (default bolded)
Start Study /Stop
Study
Purpose
Start study enables study to start. For every new study, user
needs to go into the menu and start study to enable the
study or Time counter. Stop study will finish study session.
Half press capture
On/Off
Enable capture by pressing shutter button half way.
Mark side
On/Off
Mark side of the eye to the image data.
Automatic IR contrast
On/Off
Enable automatic IR contrast
Target Blinking
On/Off
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.
Automatic exposure
On/Off
Turn automatic exposure on or off for captured images.
Capture setting in
image
On/Off
Enable or disable writing of capture settings to image.
Instant Review
On/Off
Instant review can be ON/OFF according to user need, as
available in FA Optics menu.
Start Study/Stop Study
Start study enables fluorescein angiography study to start. For every new study, user needs to go into the
menu and select start to enable the study or Time counter. Stop study finishes fluorescein angiography
study session.
Half-press capture
It is possible to take images by pressing shutter button halfway down.
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. 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.
Automatic IR contrast
Automatically adjust infrared live view brightness and contrast according to image content. Improves
visibility of fundus features during aiming. Same contrast and brightness settings are applied to IR still
captures.
NOTE: In IR/IR mode, IR brightness adjustment does not always directly affect brightness on screen when
automatic contrast is enabled. This happens because automatic contrast feature always tries to adjust
screen brightness to same level. IR brightness setting still works, but the effect is only visible when
adjustment range of automatic contrast adjustment runs out. It is advisable to use highest brightness that
does not cause image saturation (pink or white “washed out” effect).
Target blinking
By default fixation target light is on with constant illumination. If patient cannot keep their eye targeted
well light can change to blink to help focus on the target light.
Automatic exposure
Brightness of captured still image is optimized to be as bright as possible i.e. having maximum brightness.
By default, brightness optimization is on.
Page 32 of 51
Capture setting in image
It is possible to write brightness and diopter settings to image.
Instant review
Instant review can be ON/OFF according to user need, as available in FA Optics menu. When the reviewing
zoom level is 1x, user can change the image to be reviewed with left and right arrow keys. Images are in
showing order Normal, Low-red, Red-free, IR.
NOTE: Camera stores selected menu settings when it is powered off.
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 is
pressed all the way down.
2. op:FA → 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.
5. When Right Soft key is long pressed, Menu table appears on display.
Default Device tab will be ON. By using left and right arrow keys you slide to the next tab.
Time Counter:
Start study can be selected from the FA optics menu or by pressing shutter button halfway (half-press is
enabled) or by pressing shutter button all the way down. Time counter will appear on the upper right on
the screen.
Time counter will be printed on the final images. Time counter will guide you through all the phases of
Angiography.
To stop the time counter after finishing the study, user need to go to FA optics menu and press the STOP
STUDY button.
Page 33 of 51
11. Error messages
Optomed Smartscope M5 will display error messages for the limitations of the usage. Error message is
always displayed with explanatory message providing information about possible actions.
List of error messages:
Error message:
What to do:
Autofocus calibration needed Please hold camera horizontal and press OK to calibrate.
Battery failure
Remove battery completely from camera. Re-install or replace.
Charging failure
Please remove and reconnect device to cradle.
Image counter full
Copy images to safe location and then choose Erase image memory from device
menu.
Image storage not found
Please contact service for more information.
Light source temperature too Restart camera.
high
Memory erasing failed
Please contact service for more information.
Memory full
Memory is full, store images and erase memory card.
Optic type not detected
Please re-attach optics.
Optic communication failed
Please re-attach optics.
Optic control failed
Please detach optics and restart camera.
Patient list upload failed
Please verify list against instructions.
System flash memory not
available
Please contact service for more information.
Low battery. Please Charge.
Powering down.
Charge battery or change it to a new one.
Failed to access image
memory
Erasing image memory might help
Previous startup did not
finish successfully
Erasing image memory might help.
Failed to change wireless
password #
New password is invalid or the change otherwise failed. Retry to change the
password. Contact maintenance if same error happens again. The number after
the text is an error code that can be needed by customer service.
Page 34 of 51
12. Cleaning instructions
Optomed Smartscope M5 is a precision optics instrument that should be handled with care. Please note
following cleaning instructions for camera and optics modules:
•
•
•
•
Shut down device before cleaning it
Remove cradle from mains before cleaning it
Disinfect housing with soft cloth moistened with alcohol (e.g. 70% ethanol). Avoid touching
System connectors in the handset and cradle.
Lenses may be cleaned with cleaning cloth. Also moist-cleaning tissue such as Hama Pro-Optic®
cleaning tissue can be used.
Optomed Smartscope is not intended to be sterilized.
Clean Eye optics (EY4, FA) and Eye surface optics (ES2) eye cup before each use on a new patient:
•
•
•
•
disinfect eye cup with soft cloth moistened with alcohol (e.g. 70% ethanol), or
soak eye cup in glutaraldehyde based solution, or hydrogen peroxide and peracetic acid solution
such as Erisan OXY+
rinse the eye cup under running water
dry the eye cup (e.g. with clean paper towel) before subsequent use
If replacement for eye cup (EY4, FA) is needed, please contact Optomed or your own retailer.
Eye cup should be replaced if/when:
•
•
•
eye cup is discolored
eye cup form is deteriorated
eye cup is shattered, cracked or disintegrated
WARNING
Clean eye cup before each use on a new patient to avoid contamination.
Page 35 of 51
13. Device maintenance
Optomed Smartscope contains rechargeable Ni-MH battery pack. Service life of the battery is
approximately 1-2 years. Battery needs to be replaced on planned intervals. When battery is at end of its
service life, usage time of the device goes down.
Appendix B gives instructions for battery replacement.
There are no other maintenance procedures that can be carried out by the user. All servicing and repairs
other than replacing the battery must be carried out by Optomed or Optomed certified service facilities
and service personnel. Optomed Ltd will make available work instructions to repair those parts of medical
electrical equipment that Optomed Ltd has designated as repairable by service personnel.
CAUTION
If there are breaks in the device covers or other visual defects, contact Optomed
Customer Service or Optomed certified service facility.
Page 36 of 51
14. Technical description
CAMERA:
Type:
OPTOMED SMARTSCOPE M5
Image sensor:
Image memory type:
CMOS, 5.0 Megapixels
Micro SDHC card or WLAN SDHC card
Display:
2.4'', TFT-LCD, 262 000 colors, antireflective coating
Image format:
Video format:
JPEG (file extension: jpg)
MPEG-4 and MPEG-1
USB Connectivity:
WLAN Connectivity:
PC with USB or WLAN (WPA2)
802.11gn, WPA2
Frequency range: 2412 – 2462 MHz
Max radiated power: 17 dBm
Operating systems:
Windows 7®, Windows 8.1®, Windows 10®
No driver installation needed.
Dimensions:
Weight:
82,30(w) x166,50(h) x 66,50(d) mm
400 g
Battery:
Rechargeable Ni-MH Cylinder cell, 4xAAA, 4.8 V, 1000 mAh
User can change battery. Batteries provided by Optomed.
Usage time:
1h 30min with full battery
CHARGING CRADLE:
Type:
OPTOMED SMARTSCOPE CRADLE V1
Dimensions:
Weight:
170(w) x 35(h) x 150(d) mm
380 g
Switching power supply
connected to cradle:
USB cable:
CINCON TRG10R090
Input: 100-240 V ~0.4A 47-63 Hz
Output: 9V, 1.1A, 10 W
Type A to mini B, high-speed, unshielded, length 1.8 m
CAUTION
It is only allowed to attach Battery and Power source provided in the sales package
into the Cradle. If you need replacement to the Battery or Power source, please
contact Optomed Customer Service or your local Retailer.
Page 37 of 51
NON-MYDRIATIC OPHTHALMIC MODULE CONNECTED TO
SMARTSCOPE M5 CAMERA
Type:
Smartscope EY4
Intended use:
Intended to capture digital images and video of
the fundus of the human eye.
Illumination:
Infrared LED for targeting
Visible white LED for photographing , 10 illumination brightness levels
9 red Internal fixation target LEDs
Maximum Luminance output
level towards eye:
95,8 cd/cm2
Field of view:
Diopter compensation:
40⁰
- 20 D to + 20 D
Image resolution:
1536x1152 px (total 1,8 Mpix, informational area 1,41 Mpix)
Dimensions:
Weight:
160x73mm
310 g
FUNDUS ANGIOGRAPHY MODULE CONNECTED TO
SMARTSCOPE M5 CAMERA
Type:
Smartscope 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
level towards eye:
8,07 cd/cm2
Field of view:
Diopter compensation:
40⁰
- 20 D to + 20 D
Image resolution:
1536x1152 px (total 1,8 Mpix, informational area 1,41 Mpix)
Dimensions:
Weight:
160x73 mm
310 g
Page 38 of 51
EXTERNAL OPHTHALMIC MODULE CONNECTED TO SMARTSCOPE M5 CAMERA
Type:
Smartscope ES2
Intended use:
Digital eye anterior optics module. Intended to
capture digital images and video of the surface of
the human eye and surrounding areas.
Illumination:
Visible white and cobalt blue LED for photographing,
10 illumination brightness levels
Maximum Luminance output
level towards eye:
192 cd/cm2
Image resolution:
2560x1920 px
Dimensions:
Weight:
79x70 mm
90 g
Page 39 of 51
ENVIRONMENTAL CONDITIONS FOR USE, STORAGE AND TRANSPORTATION
IP Code:
IPX0 (Equipment not protected against the ingress of water)
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
Please note also 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. Appendix B gives instructions for
removing the battery.
Transported in protective aluminum carrying case:
Temperature:
- 40 C to + 70 C
Relative humidity:
10 % to 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
WARNING
Do not leave the eye cup in direct sunlight as it may warm up and burn patient’s face
when taking image.
SERIAL NUMBERING
Year of manufacture can be found from the serial number (digits 3 to 4).
Serial number of the cradle is in a sticker attached to the underside of the cradle.
Serial numbers of the attachable optics modules are attached to the modules.
SW version is displayed in the device menu.
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EXPECTED USAGE LIFE OF THE SMARTSCOPE
There are no strict limitations on expected usage life of the Smartscope. Usage life is approximately five
years.
INTELLECTUAL PROPERTY RIGHT INFORMATION
Microsoft Windows 7®, Windows 8.1® and Windows 10® are trademarks of Microsoft Corporation.
Hama Pro-Optic is a trademark of Hama GmbH & Co KG.
Erisan OXY+ is a trademark of Farmos Ltd
This software is based in part on the work of the Independent JPEG Group.
PATENT NOTICE
This product is protected by the following patent numbers and their corresponding national rights:
122533, 107120, 119531, 120958, 2200498, 5171845, 5561130, 5658371, I468147, ZL200880101934.7,
ZL200880112052.0, US 8,078,667 B2. Additional patent applications are pending.
TRADEMARK
Optomed Smartscope, its logos and other Optomed Smartscope brand trademarks and made names are
registered or unregistered trademarks of Optomed Ltd. All rights are reserved. The specifications in this
manual are subject to change without prior notice, due to continuing product development.
DISPOSING OPTOMED SMARTSCOPE PRODUCTS
Do not dispose Optomed Smartscope products as unsorted municipal waste. Prepare Optomed
Smartscope products for reuse or separate collection as specified by Directive 2002/96/EC of the
European Parliament and Council of the European Union on Waste Electronic and Electrical Equipment
(WEEE). If this product is contaminated, this directive does not apply.
Packaging materials: Sales case and transportation cardboard packaging should be retained for future
relocation or repair. If you decide to dispose of the packaging material, submit it to a recognized collection
system of recycling (Sales case consists of aluminum, plastic, foam and fabric).
For more specific information, please contact Optomed Ltd or your local retailer.
CONTACT
For after sales services please contact your local distributor.
If you need to contact Optomed Ltd additional information can be obtained:
Optomed Ltd Customer Service number: +358 20 741 3380
Optomed Ltd Customer Service email: [email protected]
Latest version of User Manual can be found: www.optomed.com
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15. Warranty
Optomed Ltd 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
Optomed Ltd. 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 Optomed certified service facility is not covered by warranty.
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Appendix A - Electromagnetic compatibility information
Special precautionary measures apply to this device with regard to electromagnetic compatibility (EMC).
If the performance of Optomed Smartscope M5 is lost or degraded due to electromagnetic disturbances,
it may cause unexpected or adverse operation of this device. If a malfunction cannot be rectified, please
contact your local distributor or Optomed customer service.
Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally. The device should not
be operated in the vicinity of high-frequency surgical equipment.
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the Smartscope
M5, including cables specified by the manufacturer. Otherwise, degradation of the performance
of this equipment could result.
Manufacturer’s declaration – electromagnetic immunity:
Smartscope M5 maintains basic safety and performance when used in the electromagnetic environment specified
below. The customer or the user of the device should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Electrostatic
discharge (ESD)
±8 kV contact
±2 kV, ±4 kV, ±6 kV,
±8 kV indirect
contact
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
±15 kV air
IEC 61000-4-2
±2 kV, ±4 kV, ±6 kV,
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
Electrical fast
transient/burst
±2 kV for power
supply lines
±2 kV for AC power
supply
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
±1 kV line(s) to line(s)
IEC 61000-4-5
±2 kV line(s) to earth
±1 kV differential
mode
Mains power quality should be that of a
typical commercial or hospital
environment.
IEC 61000-4-4
±2 kV common mode
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
0 % UT for 0,5 at 8 ф
angles;
0 % UT for 0,5 at 8 ф
angles;
0 % 1 cycle;
0 % 1 cycle;
70 % UT for 25 cycles;
70 % UT for 25 cycles;
IEC 61000-4-11
0 % for 5 sec
0 % for 5 sec
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the
Smartscope M5 requires continued
operation during power mains
interruptions, it is recommended that the
device be powered from an
uninterruptible power supply or a battery.
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Power frequency
(50/60 Hz) magnetic
field
30 A/m
30 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Conducted RF
3 Vrms
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
150 kHz to 80 MHz
&
&
6 Vrms
6 Vrms
ISM frequency
ISM frequency
Portable and mobile RF communications
equipment should be used no closer to
any part of Smartscope M5, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Radiated RF
3 V/m
3 V/m
Recommended separation distance
IEC 61000-4-3
80 MHz to 2.7 GHz
AM Modulation
80 MHz to 2.7 GHz
AM Modulation
d = 1.2 √𝑃
&
&
9–28 V/m
9–28 V/m
d = 2.3 √𝑃 800 MHz to 2.7 GHz,
385 MHz to 6.0 GHz
Pulse Modulation
385 MHz to 6.0 GHz
Pulse Modulation
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 meters (m).
IEC 61000-4-8
d = 1.2 √𝑃 80 MHz to 800 MHz
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey A, should be less than the
compliance level in each frequency
rangeB.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1: UT is the AC mains voltage prior to application of the test level
NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 3: The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765–6.795 MHz;
13.553–13.567 MHz; 26.957–27.283 MHz and 40.66–40.70 MHz.
NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
A) 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 location in which the Smartscope M5 is used exceeds
the applicable RF compliance level above, Smartscope M5 should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
Smartscope M5.
B) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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Manufacturer’s declaration – electromagnetic emissions:
Smartscope M5 maintains basic safety and performance when used in the electromagnetic environment specified
below. The customer or the user of the device should assure that it is used in such an environment.
Emission test
Compliance level
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
Smartscope M5 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/flicker
emissions IEC 61000-3-3
Complies
Smartscope M5 is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Separation distances:
Smartscope M5 maintains basic safety and performance when used in the electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of Smartscope M5 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and Smartscope M5 as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum
output power of
transmitter (W)
Separation distance according to frequency of transmitter (m)
from 150 kHz to 80 MHz
from 80 MHz to 800 MHz
from 800 MHz to 2.7 GHz
d = 1.2 √𝑃
d = 1.2 √𝑃
d = 2.3 √𝑃
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (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.
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Appendix B - Replacing the battery
Battery pack is specially designed and manufactured for this device. Optomed and Optomed retailers provide suitable battery
packs. Labels in the battery display following information:
Optomed
50600001 4xAAA
4.8V/1000 mAh
Rechargeable Ni-MH battery
Procedure for replacing the battery:
1. Ensure that camera is powered off.
2. Open the battery compartment cover by lifting from the notch in
the bottom of the device with your finger. If the cover is tight, you
may use a small tool like pen to assist in opening.
3. Remove the battery compartment cover by lifting it up.
4. Remove the old battery by placing your fingernail underneath the
connector’s edge and lifting the connector and the battery out of
their sockets to disconnect the battery.
Note! Do not lift the connector by the cables as they may be
damaged.
Note! Avoid any unnecessary horizontal or wiggling movement
when disconnecting the battery.
5. Put the new battery in the same position and attach the connector
to its socket.
6. Replace the battery compartment cover by snapping it firmly to
place.
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Appendix C - WLAN functionality
Optomed Client is a PC software which enables the wireless connection between the camera and the PC.
Installing / Uninstalling
Optomed Client software is installed by executing Optomed Client Smartscope install.exe. Please, follow
the installer instructions to complete installation. First select where the application will be installed and
then select the components you want to install. Before installation, you need to accept the license. You
can also select the start menu in which you would like to create the shortcut or you can enter a name to
create a new directory.
In case you need to uninstall Optomed Client software, it can be uninstalled from Windows Control Panel
by opening Programs and Features, selecting Uninstall for the application and following the uninstaller
instructions.
Operation
First you need to set wireless connection to on from device menu to enable WLAN. When wireless
connection is enabled, the wireless symbol is shown on display next to the battery level indicator. To view
‘WLAN SSID’ and ‘WLAN Password’, select wireless info from device menu.
When WLAN is enabled, the camera-specific access point is set up. Connect PC to the created access point,
that can be found from Windows Network & Internet settings.
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Then open Optomed Client. The camera in the network is shown on the list. Select the camera that you
want to connect and press ‘Connect device’ (figure below).
For the first time you connect the camera, you are directed to view and change general and camera
specific settings (figure below). Here you can specify the location where the images from the selected
camera will be downloaded and the location where the patient list will be uploaded to the selected
camera. For the next time, the camera connects automatically to the PC and captured images will be
automatically downloaded unless you change these settings.
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To download images manually from the selected camera, go to Camera contents (figure below). Select
images which you want to download from the list on left and press ‘Download files’.
To preview images that you have downloaded, go to Local contents (figure below). Select an image for
preview from the list on the left.
To disconnect the selected camera from Optomed Client, press ‘Disconnect’
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WLAN SD card firmware update
The WLAN SD card has its own firmware, that can be updated if needed. Follow instructions below to
update the firmware.
Preparations:
1. Download latest FlashAirFWUpdateTool from Toshiba FlashAir support pages.
2. Install FlashAirFWUpdateTool to Windows. After install, UpdateTool is found from Windows start
menu under TOSHIBA.
Update process:
1. Set USB write protection ‘Off’ from Device menu.
2. Select ‘SD card firmware update mode’ from Device menu.
3. Place the camera onto the cradle. The camera displays ‘SD card firmware update mode’ message.
4. Wait for the camera USB drive to get connected to the PC.
5. Start FlashAirFWUpdateTool in PC.
6. Select the camera USB drive as update target and press ‘Update’.
7. Wait for UpdateTool progress bar to complete.
8. When UpdateTool asks to remove the card, use Windows ‘Safely Remove Hardware’ function
from task tray to disconnect the camera USB drive.
9. When UpdateTool asks to insert the card, press any key from the camera to reset the SD card.
10. Do not yet press ‘OK’ button from UpdateTool. Wait approximately 1 minute while the camera
displays‘Programming SD card’ message.
11. When the camera shows ‘SD card firmware update mode’ message again, camera USB drive
should get reconnected.
12. If the camera USB drive is not properly mounted (may take several seconds), repeat from step 9.
13. When the camera USB drive is reconnected to PC, answer OK to UpdateTool query about inserting
the card.
14. Repeat from step 6. (normally will repeat 3 times)
15. When UpdateTool reports ‘Updated Successfully’, remove Camera from cradle and it will power
off automatically.
16. Update completed.
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