Healthmark FIS-001 Instructions For Use Manual Download Page 15

 

 

 

FIS-001 

Page 15 of 33 

 

5.0

 

MITIGATING RESIDUAL DEVICE RISKS 

5.1

 

Do NOT immerse / submerge the camera device in liquid as a residual risk of user shock 
remains in this scenario. 

5.2

 

Do NOT make rapid hand motion with the device as the flexible shaft section may whip 
and cause eye-injury or abrasion on impact with body parts. 

5.3

 

Do NOT use the device to poke or attempt to pierce any object as it may cause serious 
eye-injury or abrasion on impact with body parts in addition to device damage. 

5.4

 

Do NOT subject the device to excessively high temperatures above 120 ºF as the 
materials of construction are not designed to operate under these conditions. 

5.5

 

Do NOT allow the device to be subject to any liquid splash as a residual risk of user 
shock remains in this scenario. 

5.6

 

Do NOT grasp and handle the device from the camera head as a residual risk of fatigue 
damage to the distal tip of the device remains in this scenario.

 

5.7

 

Do NOT use the device handle to strike or hit any object. Serious harm to body and/or 
device may result. 

5.8

 

Do NOT over bend the flexible device shaft to a point of kinking. It may cause damages 
to electronic components and render the camera un-operational. 

5.9

 

Do NOT plug the USB cable into any port other than a USB2.0 (or later version) port on 
a computer. 

5.10

 

Use only the USB cable provided with the device.  Using other cables may lead to 
interference with surrounding electronic devices and potential performance deterioration. 

5.11

 

Do NOT attempt to disassemble or repair the device yourself.  Doing so voids the limited 
warranty and could cause harm to the user and/or the device.  

5.12

 

Do NOT use the device, when activated, near RF-emitting sources (Wi-Fi, cellphone, 
radio transmitters, etc.), as intermittent auto-recoverable, frame-rate loss may occur. 

 

6.0

 

USE OF THE DEVICE NEAR RF-TRANSMITTING / EMITTING SOURCES 

6.1

 

Radio Frequency (RF) emitters (Wi-Fi antennae, Radio Transmitters, power transformers, 
etc.) emit radio waves that at very close proximity to the device can occasionally cause 
the device to experience temporary frame-rate stall in video rendering (areas in the video 
image freeze).  This is generally an auto-recoverable condition and the user is not 
required to take any action, as the device will automatically return to normal video 
rendering when the radio field is removed (or the device is moved outside the radio field).  

6.2

 

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. 
 

 

Summary of Contents for FIS-001

Page 1: ...FIS 001 Page 1 of 33 Instructions for Use Healthmark Inspection Scope Camera FIS 001...

Page 2: ...General Description 3 4 0 Software Installation 5 5 0 Mitigating Residual Device Risks 15 6 0 Troubleshooting 16 7 0 Mounting The Handle on a Tripod 22 8 0 Preparation Power Up 22 9 0 Graphical User I...

Page 3: ...f you have any question or comment about any information in this IFU please contact Healthmark at 800 521 6624 x6657 or e mail at hmitdesk hmark com 3 0 GENERAL DESCRIPTION The Healthmark Inspection C...

Page 4: ...FIS 001 Page 4 of 33 Healthmark Inspection Camera Handle Extrusion Proximal End Distal End Distal Tip Camera Handle...

Page 5: ...Installation and 2 Application Software Installation 4 3 Device Driver Installation 4 3 1 Turn on the Target Computer 4 3 2 Proceed to log into the Windows desktop environment 4 3 3 Do not connect an...

Page 6: ...taller 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 doub...

Page 7: ...rmation page enter the desired information Then click the Next button 4 3 8 6 On the Setup Type page choose Complete option to install all necessary components Then click the Next Button 4 3 8 7 Click...

Page 8: ...nknown publisher to make changes to this computer Program name Cy2510Installation_x msi In case this Windows dialog box pops up click the Yes Button to continue 4 3 8 9 Another Windows Security pop up...

Page 9: ...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 4 3 11 When the Windows finishes instal...

Page 10: ...k_Install_Package folder and locate the file setup exe 4 6 Double click and run the file setup exe from the HealthMark_Install_Package folder 4 7 Install NET Microsoft Framework 4 0 if prompted If the...

Page 11: ...f Microsoft NET Framework 4 0 or above are installed successfully proceed by clicking the Next Button 4 9 Review and accept the License Agreement Click the Next Button to continue 4 10 On the Customer...

Page 12: ...nstall Button on the next dialog box screen Ready to Install the Program 4 13 A Windows User Account Control pop up dialog box may appear and display a question Do you want to allow the following prog...

Page 13: ...to the computer 4 16 Starting the Program 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 Health...

Page 14: ...FIS 001 Page 14 of 33 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...

Page 15: ...nto any port other than a USB2 0 or later version port on a computer 5 10 Use only the USB cable provided with the device Using other cables may lead to interference with surrounding electronic device...

Page 16: ...7 3 Administration Privileges Administration privileges are necessary in order to install Healthmark software on a computer Please contact your IT administrator for support 7 4 Device driver installa...

Page 17: ...ither 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...

Page 18: ...settings link 7 5 3 When the Control Panel opens click and switch to the Update recovery section 7 5 4 Click on the Recovery option on the left hand side 7 5 5 Once selected you will see an advanced s...

Page 19: ...FIS 001 Page 19 of 33 7 5 6 Once the computer has been rebooted choose the Troubleshoot option 7 5 7 Click on Advance options...

Page 20: ...FIS 001 Page 20 of 33 7 5 8 Click Startup Settings 7 5 9 Click Restart...

Page 21: ...ings 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...

Page 22: ...rew can be used to mount the handle 9 0 PREPARATION POWER UP 9 1 Turn ON the PC the Software is installed on 9 2 Plug the Type Mini B side of the provided USB 2 0 Cable to the camera handle The Mini B...

Page 23: ...lso be executed from this folder The information pop up window will appear with the following information If the Information Popup Box does not come up try restarting the application or reinstalling t...

Page 24: ...changed so that each video and image taken can be stored in a user defined location To do this click on the box that says Enter Surgical Instrument Information A key board will popup enabling the use...

Page 25: ...UI To take a still image snapshot click the PHOTO button once Each time a photo is captured the capture count will be incremented under the button If the Capture Photo as Reference radio button is NOT...

Page 26: ...of the year 18 is the day of the month 113255000 is the time of day the image is taken 10 3 Taking Photo s using the button on the device handle To capture a still image using the Control Handle press...

Page 27: ...under the button this will be for the last video that is being recorded When recording video the button color will change to red The videos will be stored in the VidTimeStamp avi format For example Vi...

Page 28: ...be the same Record Button on handle is as follows User will observe the behavior in the GUI as previously explained 10 7 Stop Recording Video s Using Button on Handle To stop recording video using th...

Page 29: ...se the brightness of the camera LEDs press the Up Arrow on the Control Handle This will be equivalent to using the GUI and the Illumination change results will be the same Up Down Button on handle is...

Page 30: ...will be turned ON at 100 10 11 Decreasing the Illumination Level Using Button on Device Handle The Down Arrow next to Illumination button can be clicked to decrease the brightness of the camera LEDs T...

Page 31: ...eo select the MENU button with a single click A single click on the MENU button will take user to Tools Box Under the Tools Box select REVIEW button with a single click A new window with all working f...

Page 32: ...g user to select an image or video to replay 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...

Page 33: ...Field Wiring Terminal Boxes 13 3 The device does NOT produce Ionizing Radiation 13 4 The device is RoHS Compliant 13 5 The device handle may get warm to the touch This is normal 13 6 The device has N...

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