Table of Contents
Related Manuals for Optomed Smartscope PRO
Summary of Contents for Optomed Smartscope PRO
- Page 1 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 Page 1 of 51...
- Page 2 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. Page 2 of 51...
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Page 3: Quick Start Guide
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. -
Page 4: Table Of Contents
Table of contents Quick start guide ..........................3 Table of contents ..........................4 Indications for use ........................ 5 Contraindications for use of the optics modules EY4, FA and ES2 ........6 Warnings and cautions ......................7 Important symbols ....................... 8 Parts of the device ........................ -
Page 5: Indications For Use
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. -
Page 6: Contraindications For Use Of The Optics Modules Ey4, Fa And Es2
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. -
Page 7: 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. -
Page 8: Important Symbols
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. -
Page 9: Parts Of The Device
5. Parts of the device Page 9 of 51... - Page 10 Cradle: Page 10 of 51...
- Page 11 Soft key indicators: Position Indicator Purpose To power on the device Left soft key 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...
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Page 12: Usage Environment Requirements
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. Page 12 of 51... -
Page 13: Operating Instructions
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. Page 13 of 51... -
Page 14: Basic Use - Starting Up, Shutting Down And Taking An Image
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. -
Page 15: Attaching And Detaching Optics Module
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... - Page 16 Table below includes explanations of the Device settings tab: Setting Values (default bolded) Purpose Preview images To preview the images on camera press middle button. New patient folder 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.
- Page 17 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.
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Page 18: Patient Editor
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. -
Page 19: Patient Folder Linking
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. -
Page 20: Retinal Imaging Using Optics Module Smartscope Ey4
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 •... - Page 21 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.
- Page 22 Camera keys function as shown in image below when Smartscope EY4 optics module is attached: Table below provides explanations for the key functions: Press Function Explanation Short Control Fixation target Fixation target is off by default and can be turned on level and selection by pressing left soft key.
- Page 23 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.
- Page 24 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.
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Page 25: Eye Imaging Using Anterior Ophthalmic Module Smartscope Es2
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 •... - Page 26 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.
- Page 27 Table below provides explanations for the key functions: Press Function Explanation Short Edit focus window/ When focus window is visible it is possible to move it using arrow keys to better capture the wanted area. Activate Zoom Digital zoom can be used for close up of features and Left soft key image focus.
- Page 28 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.
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Page 29: Fluorescein Angiography Imaging Using Optics Module Smartscope Fa
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 •... - Page 30 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.
- Page 31 Camera keys function as shown in image below when Smartscope FA optics module is attached: Table below provides explanations for the key functions: Press Function Explanation Short Control Fixation target Fixation target is off by default and can be turned on level and selection by pressing left soft key.
- Page 32 Table below includes explanations of the FA settings tab for fundus Angiography imaging: Setting Values (default bolded) Purpose Start Study /Stop Start study enables study to start. For every new study, user Study needs to go into the menu and start study to enable the study or Time counter.
- Page 33 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.
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Page 34: Error Messages
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. -
Page 35: Cleaning Instructions
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 •... -
Page 36: Device Maintenance
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. -
Page 37: Technical Description
82,30(w) x166,50(h) x 66,50(d) mm Weight: 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... - Page 38 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:...
- Page 39 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:...
- Page 40 ENVIRONMENTAL CONDITIONS FOR USE, STORAGE AND TRANSPORTATION IP Code: IPX0 (Equipment not protected against the ingress of water) Intended to be use indoors: + 10 C to 35 C Temperature, use: Relative humidity, use: 10 % to 80 % Atmospheric pressure: 800 hPa to 1060 hPa Please note also EMC information given in Annex A.
- Page 41 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.
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Page 42: Warranty
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. -
Page 43: 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. - Page 44 Power frequency 30 A/m 30 A/m Power frequency magnetic fields should (50/60 Hz) magnetic be at levels characteristic of a typical field location in a typical commercial or hospital environment. IEC 61000-4-8 Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications equipment should be used no closer to IEC 61000-4-6 150 kHz to 80 MHz...
- Page 45 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 –...
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Page 46: Appendix B - Replacing The Battery
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: Ensure that camera is powered off. -
Page 47: Appendix C - Wlan Functionality
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. - Page 48 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).
- Page 49 ‘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’ Page 49 of 51...
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Page 50: Wlan Sd Card Firmware Update
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. - Page 51 Page 51 of 51...