VP1600 HD Still Capture System Instruction Manual Rev AC

Proprietary Information This manual contains information deemed proprietary to Linvatec Corporation. The information contained herein, including all of the designs and related materials, is the sole property of ConMed Linvatec and/or its licensors. ConMed Linvatec and/or its licensors reserve all patent, copyright and other proprietary rights to this document, including all design, manufacturing methodology and reproduction. This document, and any related materials, is confidential and is protected by copyright laws and shall not be duplicated, transmitted, transcribed, stored in a retrieval system, or translated into any human or computer language in any form or by any means, electronic, mechanical, magnetic, manual or otherwise, or disclosed to third parties, in whole or in part, without the prior express written consent of ConMed Linvatec. ConMed Linvatec reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law.

Linvatec, Hall and Smart are trademarks or registered trademarks of ConMed Linvatec.

 Linvatec Corporation 2012, 2014. All Rights Reserved.

Record the Model and Serial Numbers of the VP1600 HD Still Capture System(s) and date received. Retain for future reference. Console Model No. Console Model No. Console Model No.

Serial No Serial No Serial No

Date Date Date

Table of Contents

Page

1.0 INTRODUCTION 1.1 Operating Principle...1 1.2 Indications for Use...1 1.3 Intended Use...2 1.4 Contraindications...2 1.5 Warnings and Precautions...2 1.5.1 Warnings...2 1.5.2 Precautions...3 1.6 Environmental Directives...5 1.7 Product Photographs and Drawings...5 1.8 Symbol Definitions...6 1.8.1 Product Symbols...6 1.8.2 Warning and Information Symbols...6 1.9 Confidential Patient Information and Computer Network Security...8

2.0 SYSTEM INSTALLATION AND OPERATION 2.1 Product Description...9 2.1.1 VP1600 Front Panel...9 2.1.2 Rear Panel...10 2.1.3 Keyboard Keys...11 2.2 Assembly/Installation Instructions...12 2.2.1 VP1600 Installation Instructions...12 2.2.2 Rear Panel Strain Relief...14 2.2.3 Local Printer Setup...14 2.2.4 USB Storage Setup...15 2.2.5 Menu Setup...15 2.2.6 Setup Menus...17 2.2.7 System Configuration...18 2.2.8

System Configuration (Quick Setup)...18 i

Table of Contents

Page

2.2.9 System Parameters...19 2.2.10 System Advanced...20 2.2.11 Printer Setup...21 2.2.12 DICOM...21 2.2.13 DICOM Destinations...22 2.2.14 DICOM ADVANCED...23 2.3 Operating Instructions...24 2.3.1 Operating Modes...25 2.3.2 Operation - Image Capture Mode...25 2.3.3 Operation - Image Management Mode...29 2.4 Preoperative Functional Test...33

3.0 MAINTENANCE 3.1 Cleaning Information...34 3.1.1 Warnings, Precautions and Notes...34 3.1.2 Manual Cleaning Instructions...34 3.2 Sterilization Information...35 3.2.1 Warnings, Precautions and Notes...35 3.2.2 Sterilization Instructions...35 3.3 Troubleshooting...36 3.4 Life Epectancy...37 3.5 Maintenance Schedule...37 3.6 Fuse Replacement...38 3.7 Leakage Test...39

ii

Table of Contents

Page

4.0 TECHNICAL SPECIFICATIONS 4.1 Product Technical Specifications...40 4.1.1 VP1600 Technical Specifications...40 4.1.2 Power Cord Requirements...41 4.1.3 Keyboard Specifications...41 4.2 Product Environmental Requirements...42 4.2.1 Environmental Technical Specifications...42 4.2.2 Electromagnetic Requirements...43 4.3 Accessories...47

5.0 CUSTOMER SERVICE 5.1 Assistance...49

iii

Table of Contents

Page

iv

1.0 INTRODUCTION It is recommended that personnel study this manual before attempting to operate, clean, or sterilize this or associated equipment. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices, and instructions marked on the product, and included in this manual. This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Service intervals, as listed in section “3.5 Maintenance Schedule”, are required to keep the equipment at its optimum operating performance.

1.1 Operating Principle The VP1600 HD Still Capture System is an AC-powered device that captures, prints and exports up to 1080p still images. The VP1600 HD Still Capture System is simple, easy-to-use and provides a range of image-preview options for the discerning surgeon. The system permits TRUE-HD 1080p or 720p still capture, full screen or thumbnail display of captured HD images, full image review and delete capability, and can print or save to USB or send images to PACS via DICOM. The front panel of the VP1600 HD Still Capture System includes a USB receptacle, which accepts the USB storage drives. The “Power” button controls the power to the VP1600 HD Still Capture System device. The rear panel of the Image Processor includes the AC power input module and a variety of USB, serial and other connections for appropriate accessories. The VP1600 HD Still Capture System device is provided non-sterile but is intended for reuse. The VP1600 HD Still Capture System device does not come in contact with body tissues and is not invasive. The VP1600 HD Still Capture System device is located outside the surgical sterile field. To perform the still capture function, the HD still capture system requires an HD DVI video input in 720p or 1080p format. The system responds to commands from a USB wired keyboard and remote input ports. The application software presents a GUI to the user by overlaying images on the video stream. The overlaid images are generated by the application software, communicated by the internal 32 bit parallel bus, synthesized by an FPGA, and digitally overlaid onto the video stream in real time. The input video stream and overlaid images, as required, are output through the DVI video port in the same video format as the input. Upon external or user command, the system stores a full frame image in DDR memory. The application software can manage the transfer of stored images to the printer, external storage media, and/or network upon user command or set-up preference.

1.2 Indications for Use The VP1600 HD Still Capture System captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures. The system has the capability to import patient information such as demographics and/ or procedural information from a computer system, link it with the patient images, and then transfer the linked images to other computer systems or portable media.

1

1.3 Intended Use Same as Indications for Use above.

1.4 Contraindications None.

1.5 Warnings and Precautions

!

Do not bypass this section. It contains warnings and precautions that must be thoroughly understood before operating any of the equipment. Lack of understanding or adherence to these warnings and precautions may result in injury or even death to the patient. The words WARNING, PRECAUTION, and NOTE carry special meanings and they must be read carefully. WARNING: A warning contains critical information regarding serious adverse reactions and potential safety hazards that can occur in proper use ! or misuse of the equipment. Failure to observe the information or procedures presented in a Warning may result in injury, death or other serious adverse reactions to the patient and/or surgical staff. PRECAUTION: A precaution contains instructions for any special care to be exercised by the practitioner for the safe and effective use of the ! equipment. Failure to observe the information or procedures presented in a Precaution may result in damage to the equipment. NOTE: A note is added to provide additional focused information. This information has no critical effect on the patient or equipment.

1.5.1 Warnings 1. 2. 3. 4.

5.

!

Eye protection is recommended when operating equipment. Eye injury may result. It is the surgeon's responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories. Do not use equipment if, upon receipt, package is opened, damaged, or shows any signs of tampering. Do not use equipment in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking. To avoid the risk of electric shock, this equipment must be connected to a supply mains with protective earth. The voltage and frequency characteristics must be compatible with those listed on the unit or in this manual. Do not use plug adapters or extension cords; such devices may defeat the safety ground and could result in injury.

2

6.

When energized endoscopes are used with energized endotherapy devices, including IEC60601-1 and IEC60950-1 approved devices, patient leakage currents may be additive. 7. Do not excessively bend or kink the equipment power cord or accessory cord. Always inspect cords for signs of excessive wear or damage. If wear or damage is found, discontinue use and replace immediately. Using a damaged power cord could possibly cause injury. 8. In order to completely remove power from the device, unplug the device from the wall or power source. 9. Use only the fuse type and rating specified for this device. Using the wrong type of fuse could cause damage or injury. 10. Avoid contact with other non “BF” rated powered instruments while in contact with the patient, as this may create a current leakage path to earth. 11. Clean console and all associated equipment prior to first use and after each use (See Section “3.1 Cleaning Information”). Clean and sterilize associated instrumentation used with this console if required. Reference the appropriate Instruction Manual or IFU for each piece of equipment. 12. Do not connect known damaged equipment or equipment that is corroded or wet. Failure to comply may cause injury or result in damage to equipment. 13. Do not immerse the equipment in fluids. Immersion may render the device inoperable. 14. Do not simultaneously contact the console and patient. This may contaminate the sterile field and create an unsafe electrical condition. 15. This equipment should not share an electrical outlet or grounding with life supporting or life sustaining equipment. 16. This system may cause radio interference or may disrupt the operation of nearby equipment. Avoid stacking equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the console or shielding the location.

1.5.2 Precautions 1. 2. 3. 4.

!

United States Federal law restricts sale of this device to or on the order of a physician. This device should only be used in compliance with its intended use. Handle all equipment carefully. If any equipment is dropped or damaged in any way, return it immediately for service. Use only ConMed Linvatec approved equipment, attachments and accessories. They have been tested and certified to specific medical standards. Using unapproved accessories may result in improper operation, may negatively affect EMC performance and may result in non-compliance to medical standards.

3

5.

The warranty becomes void and the manufacturer is not liable for direct or resulting damage if: • The device or the accessories are improperly used, prepared or maintained; • The instructions in the manual are not adhered to; • Non-authorized persons perform repairs, adjustments or alterations to the device or accessories. 6. Prior to each use, perform the following: • Ensure all accessories are correctly and completely attached. (Refer to section “2.2 Assembly/Installation Instructions”). • Perform the required Preoperative Functional Tests for the equipment and accessories. (Refer to section “2.4 Preoperative Functional Test”). 7. Clean and sterilize all the equipment and associated accessories according to instructions for use. (Refer to section “3.1 Cleaning Information” and section “3.2 Sterilization Information”). 8. Do not place the equipment on an unstable surface, cart, stand or table. Additionally, the equipment must remain in an upright position. 9. Only connect IEC 60950 or IEC 60601 series compliant devices to signal input or output ports. 10. Inspect all airflow inlets and outlets for any obstructions to ventilation to avoid potential overheating. 11. Ensure power cord placement does not interfere with installing the device. Additionally do not position the device so it is difficult to remove the power cord from the device. 12. Do not attempt to open or service the VP1600 as this may avoid your warranty. There are no user-serviceable parts inside. Removing the cover may introduce an electric shock hazard by exposing you to dangerous high voltages or other risks. No modification of this equipment is allowed. 13. Always observe proper shutdown procedure. Failure to do so may result in corruption and/or loss of patient data and images. 14. Follow the direction of VP1600 on-screen messages. Discontinue use if and on-screen message indicates a malfunction or if they state “discontinue use”. 15. Use only Sony® Microvault devices: models USM1GL (1GB), USM2GL (2GB), USM4GL (4GB) and USM8GL (8GB), refer to section “4.3 Accessories”. The use of other USB storage devices may result in loss of patient information and images. ConMed Linvatec does not support the use of USB devices other than those listed herein. Connect a maximum of one device to the VP1600. Do not daisy-chain multiple devices. Verify currentdraw of each device to be below maximum rating specified on the back of the unit.

4

1.6 Environmental Directives WEEE Directive [2002/96/EC] on Waste Electrical and Electronic Equipment. This statement only applies to European countries with regard to the Waste Electrical and Electric Equipment (WEEE) European Directive. The WEEE symbol on the product or its packaging indicates that this product must not be disposed of with other waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment. The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your medical equipment at the end of its useful life for recycling, please contact ConMed Linvatec. A Lithium battery is used in this device. Disposal of the battery shall be based on national regulations. Battery must be recycled or disposed of properly. NOTE for State of California, USA: State of California Requirement: Lithium Batteries contain Perchlorate Material - special handling may apply. See "http://www.dtsc.ca.gov/HazardousWaste/Perchlorate".

1.7 Product Photographs and Drawings The pictures in this manual are for reference only. Items shown may not represent the actual product. However, procedural steps are identical, unless otherwise specified. When necessary, the actual pictures will be represented.

5

1.8 Symbol Definitions 1.8.1 Product Symbols

Stand-by (ON/OFF) BMP

Universal Serial Bus

Bitmap Format

IS

Information Systems Joint Photographic Experts CMIS ConMed Integrated System JPEG Group - digital image frame compression standards. A single image frame. Imaging and DICOM Digital discrete image Communication in Medicine Still Frame Describes frame captures. ENET Ethernet USB Universal Serial Bus I/O Input/Output VP1600 HD Still Capture System

1.8.2 Warning and Information Symbols Catalog Number

REF

Serial Number

SN

Manufacturer

Date of Manufacture

Consult Instructions for Use

Refer to Instruction Manual/ Booklet (for critical safety instruction). The color is blue. DEHP Symbol

Caution

! EC REP

Authorized Representative in the European Community

CE Mark of Conformity

Prescription Only: Federal Law (USA) restricts this device to sale by or on the order of a physician

No User Service Recommended. Refer servicing to qualified ConMed Linvatec service personnel Sterile

Non Sterile STERILE STERILE

EO

Sterile - Sterilized Using EO

STERILE

Do Not Steam Sterilize

6

R

Sterile - Sterilized Using Irradiation Do Not Sterilize

Do Not Resterilize

Do Not Reuse (for Single Use Only)

Do Not Use Oil

Caution - Hot Surfaces

Eye Protection Required

Biohazard Risk

2

STERILIZE

Do Not Immerse

Quantity

QTY

~

Type B Applied Part

Type BF Applied Part

UL Classification Mark

UL Recognized Components

Rating Fuse

Fuse Location

Alternating Current

Protective Earth Ground

Equipotentiality (Equipment Potential)

Non-Ionizing Electromagnetic Radiation (RF Symbol)

Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

Use by Date

Fragile

This Side Up

Do Not Use if Package is Damaged

Keep Dry

Do Not Stack

Warning: Electrical Hazard/ High Voltage

Waste Electrical and Electronic Equipment (WEEE) Symbol. Regarding European Union end-of-life of product, indicating separate collection for electrical and electronic equipment Recycle. Batteries contain materials which must be recycled or disposed of properly. The disposal of batteries as municipal waste is prohibited. Dispose or recycle in accordance with your local, state and governmental regulations. In the U.S. call 1-800-237-0169, or outside the U.S. contact your local ConMed Linvatec representative for additional information on battery disposal or recycling.

7

1.9 Confidential Patient Information and Computer Network Security According to its intended use, the VP1600 will retain patient information that is assumed to be confidential. The protection of confidential patient information acquired by and contained within the VP1600 is the sole responsibility of the user(s). It is the user's responsibility to delete all confidential patient information from the VP1600 prior to sending it to ConMed Linvatec. The VP1600 is a self-contained computer system that may transfer confidential patient information via a computer network. The protection and confidentiality of patient information sent to a network destination from the VP1600 is the sole responsibility of the user(s). NOTE:A manufacturer disclosure statement for Medical Device Security (MDS 2) for the VP1600 is available upon request. To obtain a copy, please contact customer service (see back cover for contact information). Reference document number 835111.

When connecting the VP1600 to a computer network, ensure that adequate measures are in place to address network security threats (e.g., hackers, viruses, etc.). It is the sole responsibility of the user(s) to provide adequate computer network security in order for the VP1600 to operate within factory specifications.

8

2.0 SYSTEM INSTALLATION AND OPERATION 2.1 Product Description 2.1.1 VP1600 Front Panel

1 2

3

1.

“POWER” CONTROL - activates or deactivates the VP1600 console. Briefly press the “Power” button to activate or deactivate (place unit in standby). Always place unit in standby prior to removing power from the VP1600.

2.

POWER STATUS INDICATOR Amber: AC power is applied. VP1600 is in standby. Flashing Amber: VP1600 system software is loading. Green: VP1600 is activated (must wait for start screen to appear for first use following activation).

3.

USB PORT CONNECTOR - connection point for media export to portable USB storage device.

9

2.1.2 Rear Panel 5

12

1

2

3

6

4

7

8

9

10

11

1.

HIGH DEFINITION DVI OUT Connector - Used for the digital video signal output. Connect a high definition display.

2.

HIGH DEFINITION DVI IN Connector - Used for the digital video signal input. Connect a 1080p or 720p high definition video source.

3.

ACCESSORY Connector - Connect a USB accessory device.

4.

REMOTE STILL Connector (2X) (3.5mm Phono Jack) - Connect one or two remote cables here to remotely activate the still capture function.

5.

KEYBOARD Connector - Connect the VP1600 USB keyboard.

6.

DICOM Connector - Connect Ethernet cable for DICOM interface.

7.

PRINTER Connector - Connect the local USB printer.

8.

NETWORK Connector - Allows external control.

9.

Potential Equalization Connector (POAG) - Plug mating connector from potential equalization system to POAG to bring equipment to equal ground potential in accordance with DIN 42801.

10. Power Input Receptacle (100 - 240 V~, 50/60 Hz) - The VP1600 is equipped with a switching power supply that automatically adjusts to the line voltage being used. Accepts the supplied hospital grade power cord. 11. Fuse Module - Contains two T1.0, 250V fuses. To replace, Refer to section “3.6 Fuse Replacement”. 12. Strain Relief Mechanisms (not shown) - Use these anchor points to secure cables to the chassis. Protects the connections from loosening or breaking. Refer to section “2.2.2 Rear Panel Strain Relief”.

10

2.1.3 Keyboard Keys 1

2

3

4

5

6

8

7

9

11 13

15

10

12

14

1.

EXIT - Exits from the menu or brings the menu view back to the previous screen.

2.

START - Starts a patient study.

3.

CAPTURE - Captures a high-definition still image from the video source (only when a patient study is active).

4.

END - Closes the currently active patient study.

5.

REVIEW - Displays images for active patient study. When there is no active patient study, displays the list of procedures stored in memory.

6.

SELECT - Select/deselect the currently highlighted menu item.

7.

PRINT - Print the highlighted item or print all selected items.

8.

SAVE - Save the highlighted item or save all selected items.

9.

SETUP - Displays the setup menus.

10. SHIFT - Press in conjunction with any letter key to display uppercase letters. 11. ENTER - Move to next field or next page. Activate button on menu. 12. DELETE •

Delete adjacent letter in a text field

•

Delete last image (during Image Capture Mode)

•

Delete the highlighted item or delete all selected items

13. UP/DOWN ARROWS - Move to the next or previous input field or image. 14. LEFT/RIGHT ARROWS - Move within the characters of a user input field, or view the next option of a selectable field. 15. SEND/RESEND - Sends/Resends highlighted or selected cases to Dicom Destination.

11

2.2 Assembly/Installation Instructions 2.2.1 VP1600 Installation Instructions 1.

Attach the hospital grade AC power cord to the controller receptacle and a standard grounded wall outlet or the power strip on an approved video cart (Refer to section “4.3 Accessories”). 2. Connect the keyboard to the KEYBOARD INPUT on the VP1600 rear panel. 3. Connect a DVI cable to an HD video source DVI OUTPUT (IM4000 camera for example) and the VP1600 DVI INPUT. 4. Connect a DVI cable from the VP1600 DVI OUPUT to the video display DVI INPUT. 5. Connect a secondary “back-up” video cable directly from a camera VIDEO OUPUT to the video display VIDEO INPUT. 6. Utilizing the remote cable allows activation by an external remote control such as from a ConMed Linvatec HD camera system camera head button. Connect the supplied remote cable from the REMOTE STILL input on the VP1600 rear panel to the PRINTER output on the rear panel of the ConMed Linvatec camera controller. 7. Connect a USB printer cable to the printer and the VP1600 rear panel PRINTER receptacle. NOTE: Printer manufacturer's instructions may require printer set-up prior to connection. Refer to section “2.2.3 Local Printer Setup”. 8. Connect ethernet (network) cable to the DICOM connector. 9. Connect a USB storage device to the front panel USB connector or the rear ACCESSORY connector. Do not connect storage drives to both locations. Once all of the major connections are made, and voltage is applied to the AC power input, the unit will automatically power up and display live video and the Start Menu on the monitor. If the power up mode is set to standby (Setup Menu System Advanced Page), the VP1600 will power up only when the power button is pressed.

12

VP1600 FRONT PANEL

VP1600 REAR PANEL

8

KEYBOARD

2 4

9

3

1 7

6 USB PRINTER (OPTIONAL)

MONITOR

5 IM4000 CAMERA or EQUIVALENT

Figure 1 - Wiring Diagram

REF

Signal

Cable

Connection

1

AC Power

VP1600 to Power Source

2

Keyboard

USB

Keyboard to VP1600

3

Primary Video

DVI

HD Camera to VP1600

4

Primary Video

DVI

VP1600 to HD Display

5

Backup Video

a

HD-SDI

HD Camera to HD Display (Video)

6

Printer Remote

3.5mm

HD Camera to VP1600

7

Printer

USB

VP1600 to Printer

8

Network/DICOM

Ethernet

VP1600 to Network

9

Network/CMIS

RS-232

VP1600 to OR Control System

a. The supplied HD-SDI cable may be used to connect VIDEO or HD-SDI signals from the camera to the monitor. When connecting VIDEO as a back up line, the ConMed Linvatec IM4000 HD Camera’s HD format may be set to 1080p or 720p. When connecting HD-SDI as a backup line, the HD format must be set to 720p. The VP1600 does not support the 1080i HD format.

13

2.2.2 Rear Panel Strain Relief Anchor points have been provided on the VP1600 rear panel for the purpose of securing cables. It is recommended that the power, remote and USB cables be tied to one of these points in order to prevent accidental disconnection during cleaning and routine maintenance. 1. Using the supplied zip ties (.19” [.4826cm] width or smaller) secure the power cable to the nearest anchor point being careful to leave enough slack to form a small loop in the cable between the anchor and the Remote and USB connections. 2. To replace anchor points use only Anchor Point and Screw listed in “4.3 Accessories” (1/4” [.635cm] maximum screw length). Fasten securely. Anchor Points

2.2.3 Local Printer Setup Use of printers not approved by Conmed Linvatec is not recommended as VP1600 system operation may become compromised. Refer to section “4.3 Accessories” for a list of qualified printers. 1. Set up the printer according to the manufacturer's setup instructions. 2. Once the printer's self-tests and/or calibration process is complete, connect the printer's USB cable to the corresponding receptacle on the VP1600 rear panel. 3. Apply power to the VP1600 (if necessary). 4. Press the keyboard [SETUP] key to go to the SYSTEM CONFIG page. 5. Verify that the printer appears as READY. 6. If desired, a test page may be printed by highlighting the PRINT TEST PAGE button and pressing [ENTER] on the PRINTER page. 7. Configure the print settings on the SYSTEM CONFIG page and exit the setup menu by pressing the keyboard [EXIT] button. NOTE: To automatically print patient studies in the fastest possible fashion, set the camera video format to 720p, enable VP1600 “Auto-Print” and set VP1600 “Print When” to “Page Full”.

14