Healthmark FIS-001 Instructions For Use Manual

Inspection scope camera

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Instructions for Use

Healthmark Inspection Scope Camera FIS-001

FIS-001

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Page 1 Instructions for Use Healthmark Inspection Scope Camera FIS-001 FIS-001 Page 1 of 33...
Page 2: Table Of Contents
Troubleshooting ..........................16 Mounting The Handle on a Tripod ....................22 Preparation & Power-Up ........................ 22 Graphical User Interface (GUI) ...................... 24 10.0 Accessories ............................. 33 11.0 Maintenance ........................... 33 12.0 User Notices ........................... 33 FIS-001 Page 2 of 33...
Page 3: Introduction
GENERAL DESCRIPTION The Healthmark Inspection Camera has an extrusion with a light source and camera lens at the distal tip. The outer diameter of the extrusion and camera head is 3.1mm max. The device should never be inserted into a lumen or working space smaller than 3.2mm in diameter. Any smaller lumen may cause the device to become stuck, rendering the inspected equipment unusable, and possibly damaging the camera device.
Page 4 Healthmark Inspection Camera Proximal End Distal End Handle Extrusion Distal Tip Camera Handle FIS-001 Page 4 of 33...
Page 5: Software Installation
4.3.2 Proceed to log into the Windows desktop environment. 4.3.3 Do not connect any Healthmark camera device to the computer during the installation process unless instructed to do so. 4.3.4 Obtain the Installation software on the USB flash drive provided and insert it into the USB port of the computer.
Page 6 4.3.7 Locate the proper device driver installer: Open the Healthmark folder. Depending on 32-bit or 64-bit system architecture, double click and open the “32bit_driver” or “64bit_driver” folder accordingly. 4.3.8 Initiating the driver installer - double click and run the following file: 4.3.8.1...
Page 7 Then click the “Next” button. On the “Setup Type” page, choose “Complete” option to install all 4.3.8.6 necessary components. Then click the “Next” Button. Click the “Install” Button on the next dialog box screen. 4.3.8.7 FIS-001 Page 7 of 33...
Page 8 “Windows can’t verify the publisher of this driver software.” Choose the option, “Install this driver software anyway.” 4.3.8.10 Review the next pop-up dialog box. Then click the “OK” Button to proceed. FIS-001 Page 8 of 33...
Page 9 4.3.8.11 At the InstallShield Wizard Completed screen, click the “Finish” Button to proceed. 4.3.9 Connect a Healthmark Inspection Camera to USB2.0 port of the computer using the provided USB cable. 4.3.10 A Windows balloon message may pop up at the lower right-hand corner and display a message: “Installing device driver software”.
Page 10 Application Software Installation If the Healthmark Application Software has been installed on the computer before, continue to install the new application software to obtain the latest software update. Locate the application software installer on software CD: Open the HealthMark_Install_Package folder, and locate the file “setup.exe”.
Page 11 If Microsoft .NET Framework 4.0 or above are installed successfully, proceed by clicking the “Next” Button. Review and accept the License Agreement. Click the “Next” Button to continue. On the “Customer Information” page, enter the desired information. Then click the 4.10 “Next” button. FIS-001 Page 11 of 33...
Page 12 A Windows “User Account Control” pop-up dialog box may appear and display a 4.13 question: “Do you want to allow the following program from an unknown publisher to make changes to this computer?” “Program name: …HealthmarkInstallation.msi”. If this dialog box appears, click “Yes” to continue. FIS-001 Page 12 of 33...
Page 13 Double click the “HealthMark1.0.6.14.exe” shortcut from the Desktop to run the program. If the shortcut is not available, navigate to the folder C:\Sanovas\Healthmark1.0.6.14, and locate the “HealthMark.exe” program. Double click and run the program. An “Imaging Software” dialog box will then appear. Click the “OK” Button to proceed. 4.17...
Page 14 4.18 The Main window of the camera software will now appear: If any of the above pop-up dialog box does not come up, please refer to troubleshooting or contact Sanovas for support. FIS-001 Page 14 of 33...
Page 15: Mitigating Residual Device Risks
Normal background radio transmission is generally insufficient to cause these behaviors to manifest. In the instance where strong RF emitters or fields (>5V/m) are known to exist the user is cautioned from using the device as more serious video rendering issues may be triggered. FIS-001 Page 15 of 33...
Page 16: Troubleshooting
Please contact your IT administrator for support. Device driver installation verification After you install the device driver and connect the Healthmark Inspection Camera, locate the Device Notification icon at the lower right-hand corner. Click on the Device Notification icon. If the device driver installation was successful and the provided Healthmark device is valid, the option “Eject Cyp-ver1.7”...
Page 17 Install Device Driver on Windows 8 or higher The Healthmark software requires a platform of either Windows XP or Windows 7. However, if it is necessary to install it on a Windows 8 system, the driver signature verification will need to be disabled in order to install unsigned drivers. Follow the procedures below: 7.5.1...
Page 18 7.5.3 section. Click on the “Recovery” option on the left hand side. 7.5.4 7.5.5 Once selected, you will see an advanced startup section appear on the right hand side. Click on the “Restart now” button. FIS-001 Page 18 of 33...
Page 19 Once the computer has been rebooted, choose the “Troubleshoot” option. 7.5.6 Click on “Advance options”. 7.5.7 FIS-001 Page 19 of 33...
Page 20 Click “Startup” Settings. 7.5.8 Click “Restart”. 7.5.9 FIS-001 Page 20 of 33...
Page 21 7.5.10 A list of startup settings will be shown. Press F7 to choose “Disable driver signature enforcement”. 7.5.11 The computer will then reboot and the unsigned drivers should be able to install without any Windows error message. 7.5.12 Reinstall the device driver per IFU procedures. FIS-001 Page 21 of 33...
Page 22: Mounting The Handle On A Tripod
Plug the Type Mini-B side of the provided USB 2.0 Cable to the camera handle. The Mini-B connector looks like: Plug the Type A side of the provided USB 2.0 Cable to the computer where the Healthmark software is installed. The Type A connector looks like: FIS-001...
Page 23 Starting the GUI To run the Healthmark software, locate and double-clicking on the Healthmark program icon on the Windows desktop. If the shortcut is not available, the application file should be in a folder named C:\Sanovas\ It can also be executed from this folder.
Page 24: Graphical User Interface (Gui)
With either the keyboard on screen or an externally attached keyboard type the name of the test/procedure followed by the “Enter” key. All images & videos captured will now be stored under the folder. ImageData\Date_<Surgical Instrument Information Entered> For example: FIS-001 Page 24 of 33...
Page 25 Procedure Window. Files can be retrieved from : ImageData\Date_< Surgical Instrument Information Entered > If the “Capture Photo as Reference” radio button is selected, the images will be stored in the “reference” folder under ImageData. FIS-001 Page 25 of 33...
Page 26 This will be equivalent to using the GUI and the results will be the same. Photo Button on handle is as follows: User will observe the image capture behavior in the GUI as previously explained. FIS-001 Page 26 of 33...
Page 27 For example: Vid20140321101505000 , where 2014 part is the year 2014 part is the 3 month of the year part is the day of the month 101505000 part is the time of day video recording began. FIS-001 Page 27 of 33...
Page 28 User will observe the behavior in the GUI as previously explained. 10.8 Increasing the Illumination Level Using GUI The “Up Arrow” next to “Illumination” button can be clicked to increase the brightness of the camera light (LEDs). FIS-001 Page 28 of 33...
Page 29 The LED brightness is increased by 10% every time the button is pressed. The GUI will have a different representation of each level selected. Once 100% is reached if the increase button is pressed again, the LEDs will be turned OFF. FIS-001 Page 29 of 33...
Page 30 The LED brightness is decreased by 10% every time the button is pressed. The GUI will have a different representation of each level selected. Once 0% is reached if the decrease button is pressed again, the LEDs will be turned ON at 100%. FIS-001 Page 30 of 33...
Page 31 Under the “Tools” Box, select “REVIEW” button with a single click. A new window with all working folders will be displayed. Select the folder to be opened. Click on “OPEN” button to select the folder for review. FIS-001 Page 31 of 33...
Page 32 Select the file to be reviewed by double-clicking on it. The image/video will be displayed in a new window. To quit, select the “x” button in the Setup Box and “EXIT” button in the Tools Box. This will take user to the startup interface. FIS-001 Page 32 of 33...
Page 33: Accessories
Training is required for end users to use this device. 13.10 The device can and will be packaged in single or bulk quantities. 13.11 The device will be packaged in a way that the flexible shaft is not kinked during the shipment. FIS-001 Page 33 of 33...