OLIVE Medical OVSI Video System Instructions for Use Jan 2013

© 2013 Olive Medical Corp. All rights Reserved The information presented in this document has been carefully reviewed to ensure that the OVS1 Video System can be safely and properly used. However, no guarantee is stated or implied relating to the correctness of the information provided herein. This document is subject to change without notice. The information presented in this document is for reference only. Reference to products manufactured or distributed by companies other than Olive Medical does not imply recommendation or endorsement. This information presented in this document is proprietary and protected by copyright. No part of this document may be reproduced or copied by any means without prior written permission of Olive Medical Corp. Olive Medical and OVS1 are either registered or unregistered trademarks of Olive Medical Corp. All other trademarks are the property of their respective owners.

Contents Warnings and Cautions…………………………………...

1

Declarations of Conformity……………………………….

2

Safety Classifications……………………………………..

3

Definition of Symbols……………………………………...

4

General Information……………………………………….

5

Setup and Pre-Use Information………………………….

6

Operating Instructions…………………………………….

7

Post-use Instructions……………………………………...

8

Re-Use Information………………………………………..

9

Settings…………...………………………………………..

10

Troubleshooting….………………………………………..

11

Cleaning Information…………………….………………..

12

Recycling/Disposal………………………………………..

13

Technical Description……………………………………..

14

EMC Information…………………………………………..

15

Limited Express Warranty…………………………...

16

Return Policy………………………….……………………

17

1

Warnings and Cautions It is important to read this document completely prior to installation, setup, use, or postuse activities. Throughout this document, the appearance of specific symbols and the text “WARNING!”, “CAUTION!”, and “NOTE!” is important to review. Each text carries special meaning: Symbols

Meaning

WARNING!

Failure to observe can result in injury to the patient or user

CAUTION!

Failure to observe can result in damage to the device

NOTE!

Tips for optimal operation and other useful information

To avoid injury to the patient or user, the following warnings must be observed WARNING! Unpack and inspect this device for damage prior to installation, setup, or use. WARNING! This device is for use by a qualified physician only. WARNING! Test this equipment prior to installation or setup, and run pre-use checks prior to each use. WARNING! Do not use this device if it is damaged. WARNING! Discontinue use of this device if it malfunctions. WARNING! Do not use this device in the presence of explosive gasses.

2

Declarations of Conformity Council Directives of European Standards: This device complies with 93/42/EEC of the Council Directives of European Standards. This device has been tested and found to comply with the requirements of EN 60601-1-2:2007. This device has been tested and found to comply with the requirements of EN 60601-1:2006 so as to conform to the Medical Device Directive 93/42/EEC.

3

Safety Classifications

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

This Class A digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe A est conforme à la norme NMB-003 du Canada.

4

Definition of Symbols Symbol

Meaning Do not place in general waste bin. Recycle separately according to local or national ordinances TYPE BF applied part Camera Head Connector USB Cable connector Supply mains disconnected Supply mains connected Debug Port Equipotentiality Plug In addition to the definition in Section 1, this symbol is used on the device. On the device, this symbol means “WARNING! Consult Instructions For Use before use” Fuse location and information Record ON/OFF notification White Balance notification Settings Button Patient Information Button Print Button Light Source Button Navigate Left Button Navigate Right Button Capture Image Button

Start/Stop Video Record Button White Balance Button Hide Button Review Pictures Button Back Button Video Settings Button Camera Settings Button Color Settings Button System Settings Button Restore System Defaults Button Hysteroscopy Surgical Specialty Preset Fiberscope Surgical Specialty Preset

ENT Surgical Specialty Preset

Cystoscopy Surgical Specialty Preset Custom Surgical Specialty Preset Arthroscope Surgical Specialty Preset Laparoscopy Surgical Specialty Preset Image Not Captured Indicator USB Indicator Keyboard Indicator Printer Indicator

5

General Information

5.1

About These Instructions For Use These Instructions For Use are intended to aid the user in safe and proper installation, setup, and operation of the OVS1 Video System. The descriptions in this manual are representative only of: Device Catalogue Number: OMEDFG10002

Information pertaining to these Instructions For Use: Part Number: OMEDDWG00352R02 Last Revision: 2013-01

5.2

Contents of Device Packaging Quantity One (1) Two (2) Four (4) One (1) One (1) One (1) N/A

5.3

Item OVS1 Video System Attachable Feet M4 Screws 12 ft. Power Cable USB Flash Drive Instructions for Use Booklet Recyclable and/or Disposable Packaging

Reorder Number OMEDFG10002 N/A N/A OMEDFG90013 OMEDFG90015 OMEDDWG00352 N/A

Intended Use, Indications, and Contraindications Indications for Use: The OVS1 Video System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The OVS1 Video System is indicated for use with a compatible Olive Medical Camera Head and other accessory devices including an endoscope, optical coupler, and light cable.

Contraindications: There are no known contraindications. It is the duty of the physician in charge to determine whether the application of the OVS1 Video System is acceptable based on the patient’s condition. WARNING! For critical applications, we strongly recommend that a replacement OVS1 Video System be available in case of any device failures.

5.4

Compatible Devices and Accessories Item TCK1 Camera Head Light Cable – 10ft. OHD1 High Definition Surgical Display MediCapture USB 300 HD Medical Recorder Sony HVO-1000 Digital Capture Device Sony UP-DR80MD Printer Sony BZMD-KEY1 USB Keyboard USB Flash Drive DVI Cable - 1m, 2m, 3m, 5m Remote Cable – 3ft, 6ft, 12ft, 25ft Hospital Grade Power Cord – 6ft, 12ft, 25ft

Catalogue Number OMEDFG10000 OMEDFG20006 OMEDFG20005 OMEDFG30002 OMEDFG30000 OMEDFG30001 OMEDFG30003 OMEDFG90015 OMEDFG90008, OMEDFG90009, OMEDFG90010, OMEDFG90011 OMEDFG90004, OMEDFG90005, OMEDFG90006, OMEDFG90007 OMEDFG90012, OMEDFG90013, OMEDFG90014

Additional compatible devices and accessories which have been verified by Olive Medical are available in the catalogue and/or through your sales representative. WARNING! Use of other devices which have not been verified as compatible by Olive Medical is not recommended and may result in unsafe conditions. WARNING! Equipment which uses RF communications may affect the performance of the device during use causing unsafe conditions

6

Setup and Pre-Use Information

6.1

Installation Information The OVS1 Video System may be installed onto a standard MIS-D 100 VESA Mount or for stand-alone use using the two detachable feet in the accessories box. To install the device onto a MIS-D 100 VESA Mount, use the following instructions •

•

Align the four holes in a square on the back of the OVS1 Video System to the four holes on your chosen MIS-D 100 VESA Mount and fasten using the 4 included M4 screws. Tighten screws to between 8 and 12 in-lb.

To install the attachable feet, use the following instructions • • • •

Insert the small rectangular tab on the back of the attachable foot into the matching rectangular hole on the back of the device as shown in Figure 1. Align the round plastic locking pin with the matching hole on the bottom of the device and insert the locking pin into the device as shown in Figure 1 Press the locking pin until it clicks into place, holding the foot securely onto the device as shown in Figure 1. Repeat for the second foot.

Figure 1: Foot Attachment

Prior to use, connect required devices and components as well as applicable accessories as follows: •

•

•

•

•

Connect the female end of the included power cable to the male connector on the OVS1 Video System. Connect the male end into a wall outlet which meets the specifications provided in the Technical Specifications section of this document. This outlet must have protective earth. If either the Sony HVO-1000 Digital Capture Device or MediCapture USB 300 HD Medical Recorder are being used: o Connect one end of the DVI output from the OVS1 Video System to the DVI Input on the capture device using a DVI cable (not included). o Connect remotes cables from the OVS1 Video System to the capture device by connecting one remote cable from the Remote 1 output on the OVS1 Video System to the image capture remote input on the digital capture device. Connect a second remote cable from the Remote 2 output on the OVS1 Video System to the video capture remote input on the digital capture device. o If a secondary video display is desired, connect video from the capture device to the OHD1 HD Surgical Display in accordance with the Instructions For Use for both devices. Generally, video output from the digital device must be connected with the video input of the OHD1 Surgical Display. If no video capture device is being used but a secondary video display is desired, connect one end of the DVI output from the OVS1 Video System to the DVI Input on the OHD1 Surgical Display using a DVI cable (not included). If the Sony UP-DR80MD Printer is being used, connect a USB-A to USB-B cable (not included) from either USB-A port on the OVS1 Video System to the USB-B port on the printer. The Printer Indicator will appear when the Printer is properly connected. If the Sony BZMD-KEY1 USB Keyboard is being used, connect its USB cable to either of the USB-A ports on the OVS1 Video System. The Keyboard Indicator will appear when the Keyboard is properly connected. WARNING! To avoid the risk of electric shock, this device must only be connected to a supply mains with protective earth. CAUTION! Do not drop the device. Damage may result. NOTE! The Service Port does not have any functionality available to the user.

6.2

Setup Information 6.2.1 Basic Setup Turn on the supply mains power switch located on the side of the device. Color bars will appear on the display until the Camera Head is connected. Connect the male Camera Head Connector on the Camera Head cable to the female Camera Head Connector on the side of the OVS1 Video System by aligning the red dot on the male connector with the red dot on the female connector and inserting. Live video will appear on the display if the Camera Head is properly connected. Connect the male end of the Light Cable to the Light Source by inserting the connector until it comes to a natural stop in the receptacle. White Balance the camera before use. Please refer to the White Balance portion of the Operating Instructions section of this document. NOTE! Improper White Balance or lack of White Balance prior to use may cause poor video quality.

6.3

Pre-Use Check Ensure the OVS1 Video System is properly setup and functioning by powering on the OVS1 Video System and connecting a Camera Head. Video will appear on the display if the video-system is properly setup. Ensure the Light Source properly activates by touching the display to bring up the Main Menu. Toggle the Light Source off and on by pressing the Light Source Control Button. Hide the Main Menu by pressing the Hide Button. If video fails to appear, ensure the supply mains power switch is turned on and the Camera Head Connector is fully inserted with the red dots aligned on each connector. If light fails to appear, ensure the supply mains power switch is turned on and press the Light Source Control Button again. If video or light still fails to appear, contact the sales representatives from whom you purchased the OVS1 Video System.

NOTE! Run through pre-use checks before each use of the camera to ensure the device is functioning properly prior to surgery. WARNING! Do not use the device if it is improperly setup or not functioning properly after setup. WARNING! Do not look directly at the Light Source or tip of the light cable.

7

Operating Instructions The Main Menu may be shown by touching the display and may be hidden by pressing the Hide Button. NOTE! All operational instructions and Notes provided in this section describe functionality of the device with Factory Settings. To adjust device control options, consult the Settings section of these Instructions for Use.

7.1 Startup and General Operation When the OVS1 Video System is powered on, a startup screen will appear with the Olive Medical logo. After several seconds, the display will show either color bars (if no camera head is connected) or live video. During normal use, the OVS1 Video System does not require attention. It is designed to function with or without input from the user until it is turned off.

7.2

Light Source Activation/Deactivation Turn the Light Source on or off by long press of the Minus Button on a connected Camera Head or with the Light Source Control Button or Slider on the Main Menu. NOTE! The Light Source may only be turned on if a Camera Head is connected. WARNING! Do not look directly at the Light Source or tip of the light cable.

7.3

Image Capture and Review Images can be captured by short press of the P Button on the Camera Head or with the Capture Button on the Main Menu. NOTE! When a large number of images are captured consecutively, the system may not be able to save additional images for a period of time. The Image Not Captured Icon will appear on the screen to indicate when any image has not been captured for this reason. NOTE! Images captured during a case are stored on the device until it is powered off. Power off the device to clear images between cases. Images can be reviewed by pressing the Review Pictures Button on the Main Menu. Use the Navigate Left Button and Navigate Right Button to navigate between images. Press the Back Button to return to the Main Menu after review.

7.4

Image Storage and Printing Captured Images are automatically transferred to a compatible USB Thumb Drive when properly connected. A USB transfer status message will appear on the bottom of the display during image transfer. Avoid powering off the system during image transfer. Images captured prior to connection of a compatible USB Thumb Drive will be saved when the USB Thumb Drive is connected. NOTE! The USB Indicator will appear in the top right of the display when a compatible USB Thumb Drive is properly connected.

NOTE! Turning off the supply mains power switch while the light on the flash drive is blinking will result in corrupted image files. Printing begins when the Print Button is pressed on the Main Menu or when the Camera Head is disconnected. A compatible Printer is required for printing of pictures. A printer status message will appear at the bottom of the display during image transfer. NOTE! The Printer Indicator will appear in the top right of the display when a compatible Printer is properly connected. NOTE! Turning off the supply mains power switch on the side of the device will cause any images not yet printed to be lost.

7.5

Start/Stop Video Capture Video Capture can be started and stopped by pressing the Video Button on the Main Menu when a compatible Video Capture Device is properly connected.

7.6

Video Exposure Adjustment Video Exposure can be adjusted using the Plus Button and Minus Buttons on the Camera Head. Video Exposure can also be adjusted in the Video Settings Menu. See the Settings Section of these Instructions For Use for further information. NOTE! Video Exposure levels are reset each time the device is turned off.

7.7

White Balance Video White Balance can be set by long press of the Plus Button or by pressing the White Balance Button on the Main Menu. Perform White Balance with the Camera Head pointed at a white surface. NOTE! Use the White Balance function only when the camera is pointed at a fully white scene. Using the White balance function on a scene which is not fully white may cause poor video output. To correct this, White Balance the video again correctly.

7.8

Video Specialty Surgical Specialty Presets may be selected on the Main Menu by navigating through Surgical Specialty Presets using the Navigate Left and Navigate Right Buttons. Color Settings and Video Settings (with the exception of Video Output) are specific to the Video Specialty Preset on which they were adjusted. Changing presets will cause Color Settings and Video Settings to be changed. Color Settings and Video Settings adjusted on the device will remain at their adjusted levels until Factory Defaults are Restored as described in the Settings Section of these Instructions For Use. The Fiberscope Surgical Specialty Preset uses a video algorithm which is desirable only for fiberscope applications. This Surgical Specialty Preset should not be used for nonfiberscope surgeries.

7.9

Patient Information Patient Information can be entered by clicking the Patient Info Button on the Main Menu. Up to four lines of patient information may be entered by using the tab button or enter button to switch between lines. Alternatively, select the desired line by touching it on the display. Information on all lines will be printed with images printed to an attached compatible Printer. Information on the first line will be displayed at the top of the display during the case, saved with images to the Flash Drive, and printed to Printers connected via external video capture devices.

8

Settings All Settings described in this section are accessed by first touching the display to bring up the Main Menu and then by pressing the Settings Button. To return from any of the settings menus, press the Back Button until you reach the Main Menu.

8.1

Settings Menu Picture Preview can be turned off and on using the Navigate Left and Navigate Right buttons adjacent Pic Preview. The number of images printed on each page of a connected Printer can be adjusted between 1, 2, 4, and 8 by using the Navigate Left and Navigate Right buttons adjacent to Prints Per Page. The number of copies of printed images can be adjusted from 1 to 10 by using the Navigate Left and Navigate Right buttons adjacent to Number of Copies. The Case Timer can be displayed or hidden by using the Navigate Left and Navigate Right buttons adjacent to Case Timer. The Light Source Guard can be disabled or enabled by using the Navigate Left and Navigate Right buttons adjacent to Light Source Guard. When enabled, the Light Source Guard will only allow the Light Source to turn on when a Camera Head is connected.

8.2

Video Settings Menu The Video Settings Menu can be accessed from the Settings Menu by Pressing the Video Settings Button. Video enhancement level can be adjusted using the Slider adjacent to Enhance. Sensor exposure duration can be adjusted using the Slider adjacent to Exposure. Digital gain can be adjusted using the Slider adjacent to Digital Gain. Automatic shutter reaction speed can be adjusted using the Slider adjacent to Shutter Speed. Various video gamma curves can be selected by using the Navigate Left and Navigate Right Buttons adjacent to Gamma. Various video output resolution and timing settings can be selected by using the Navigate Left and Navigate Right Buttons adjacent to Output.

NOTE! Changing Output will cause temporary loss of video. Video will resume within a few seconds.

8.3

Camera Button Settings The Camera Head Buttons Menu can be accessed from the Settings Menu by Pressing the Camera Settings Button. Various Camera Head Button functions can be selected for each Camera Head Button by using the Navigate Left and Navigate Right Buttons adjacent to the Button image and click-duration for which the function change is desired.