Biovision Technologies
NeedleCam HD Model 1080L Operation and Service Manual July 2015
Operation and Service Manual
32 Pages

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BioVision Technologies, L.L.C. Model: 1080L Operation and Service Manual
BioVision Technologies NeedleCam HD™ 1080L Integrated Visualization System with MediaCapture USB
Operation and Service Manual
221 Corporate Circle, Suite H Golden, Colorado 80401 USA
Tel. 303-237-9608 Fax. 303-237-0757
biovisiontech.com
Copyright © 2005-2014 BioVision Technologies LLC All Right Reserved. Any reproduction of this material, in whole or in part, either through conventional or electronic means without the express written permission of BioVision Technologies LLC is strictly prohibited.
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Table of Contents
Page #
1. Introduction 1.1 The NeedleCam HD™ Integrated Visualization System 1.2 Indications for Use 1.3 Contraindications 1.4 Regulatory Compliance 1.5 Warranty Information 1.6 How to Use This Manual 1.7 List of Symbols
8 8 9 9 9 11 12 12
2. Product Specifications 2.1 Contents 2.2 Features and Specifications 2.2.1 NeedleCam HD™ Features 2.2.2 Technical Specifications 2.3 Safety Information
13 13 14 14 16 17
3. Setup and Basic Usage 3.1 Setup 3.1.1 NeedleCam HD™ System 3.1.2 Attaching External Video Devices 3.1.3 Attaching a Camera Hand piece and Endoscope 3.1.4 Attaching a Sterile Scope Within the Sterile Field 3.1.5 Focussing the Camera 3.2 Basic Usage 3.2.1 Setup for Each Procedure 3.2.2 Power-Down Procedures 3.2.3 Single-use Endoscope Disposal
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4. “The Software” 4.1 Software Basics 4.1.1 Monitor Interface 4.1.2 Button Interface 4.1.3 Mode Menu 4.2 Entering Patient Information 4.3 Modes 4.3.1 Live Mode 4.3.2 Preview Mode 4.3.3 2X Zoom Mode 4.3.4 Set Date/Time 4.3.5 2 Minute Record Limit Mode 4.3.6 Rotate 180° Mode 4.3.7 Camera LED On/Off 4.4 Color Bar
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5. Cleaning and Maintenance 5.1 General cleaning of NeedleCam HD™ System 5.2 Sterilization of NeedleCam HD™ 5.3 Storage Procedure
27 27 28 28
6. Troubleshooting 7. Index of Figures
28 31
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IMPORTANT The Biovision Technologies NeedleCam HD™ Integrated Visualization System is indicated to provide illumination and visualization of anatomy in an interior cavity of the body through a natural or surgical opening. This device is indicated for diagnostic and operative arthroscopic and endoscopic procedures. The device is to be used by a trained physician for the indicated uses only. This manual describes the recommended procedures for preparing and operating the NeedleCam HD™. It does not describe how any medical procedure is to be performed on a patient with this instrument. Read all instructions in this manual carefully before using the NeedleCam HD™ Integrated Visualization System. Carefully follow all safety instructions to prevent injury to the user or patient, fire hazards, electrical shock, and damage to the device. To maintain this device in optimal conditions, follow all recommendations in this manual for handling, cleaning, and storage.
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1. Introduction Thank you for your purchase of the NeedleCam HD™ Imaging System from BioVision Technologies. The NeedleCam HD™ is designed and built to give you the latest technology and the best performance for your practice. This manual will help you make the most of your equipment investment. 1.1 The NeedleCam HD™ Integrated Visualization System The NeedleCam HD™ system combines several essential surgical requirements into a single compact & portable package: LED Light Source By employing state-of-the-art light emitting diode technology, BioVision Technologies’ proprietary LED Light Source incorporates high efficiency and low heat image illumination. Proprietary High Definition Camera System The NeedleCam HD™ system uses high-resolution 1080i digital display technology. A quick-release optical connector that adapts to a wide variety of BioVision Technologies’ surgical endoscopes. BioVision Technologies’ proprietary single cable design eliminates the complexity and cost of the traditional dual cable system approach. Multiple Video Outputs Multiple Output options on the NeedleCam HD™ system allow connection to larger High Definition video monitors by HDMI or RGB Component connections. MediaCaptureUSB A full-featured, fully-integrated image capture system is included in every NeedleCam HD™ system. Every NeedleCam HD™ has the capability to capture still images, and full-resolution video. Using the popular USB Flash Drive format, MediaCaptureUSB enables users to quickly and conveniently document their procedures. Using the Preview feature of the NeedleCam HD™ operating system you can browse captured media, delete images or transfer images to an external storage device.
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Disposable Fiberoptic Endoscopes The NeedleCam HD™ Imaging system uses BioVision Technologies’ proprietary scope coupling system. Only scopes provided by BioVision will work with this imaging system. A wide variety of one time use endoscopes are available from BioVision Technologies for many different procedures. Each endoscope is designed specifically for its intended use. Generic visualization endoscopes are available in a variety of diameters, lengths, and viewing angles. USB Ports The NeedleCam HD™ Imaging system has three USB ports that can be used for USB Flash Drives, Keyboards, or Mice. Note: The system will only recognize one USB Flash Drive at a time. 1.2 Indications for Use The NeedleCam HD™ Integrated Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. 1.3 Contraindications The NeedleCam HD™ Integrated Visualization System is contraindicated for use in applications where high intensity light might damage tissue such as neonate transillumination and some opthalmic procedures. For other contraindications, consult the literature accompanying the instrumentation utilized with this device. 1.4 Regulatory Compliance Federal law restricts this device to sale by or on order of a physician licensed by the law of the state or country in which they practice; to use or order the use of this device. · The NeedleCam HD™ Integrated Visualization System complies with all regulations to be marketed in the United States of America, Korea, and the European Union. · This device complies with IEC 60601-1 and all collateral standards. · This device complies with part 15 of the FCC rules. · This device complies with the Medical Device Directive (Council Directive 93/42/EEC). · Electromagnetic Compatibility (IEC 60601-1-2) · This device complies with the Waste Electrical and Electronic Equipment Directives
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Guidance and Manufacturer’s Declaration- Electromagnetic Emissions The NeedleCam HDTM is intended for use in the electromagnetic environment specified below. The customer or the user of the NeedleCam HDTM should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions Group 1 The NeedleCam HDTM uses RF energy only for its internal function. Therefore, its RF emissions CISPR 11 are very low and are not likely to cause any interference in nearby electronic equipment. RF Emissions Class B The NeedleCam HDTM is suitable for use in all establishments other than domestic and those CISPR 11 directly connected to the public low-voltage power supply network that supplies buildings used Harmonic Emissions Class A for domestic purposes. IEC 61000-3-2 Voltage Fluctuations / Complies Flicker Emissions IEC 61000-3-3
Guidance and Manufacturer’s Declaration- Electromagnetic Immunity
The NeedleCam HDTM is intended for use in the electromagnetic environment specified below. The customer or the user of the NeedleCam HDTM should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Electrostatic + 4 kV contact + 40 kV contact Floors should be wood, concrete or ceramic tile. Discharge (ESD) If floors are covered with synthetic material, the IEC 61000-4-2 + 8 kV air + 8 kV air relative humidity should be at least 30%. Electrical Fast + 2 kV for power supply lines + 2 kV for power supply Mains power quality should be that of a typical Transient/Burst +1 kV for input/output lines lines commercial or hospital environment. IEC 61000-4-4 +1 kV for input/output lines Voltage Dips, short <5% UT(>95% dip in UT for 0,5 cycle 100% dip for 0.5 cycles Mains power quality should be that of a typical commercial or hospital environment. If the user of the interruptions and 40% UT (60% dip in UT) for 5 cycles 60% dip for 5 cycles NeedleCam HDTM requires continued operation during voltage variations 70% UT(30% dip in UT) for 25 cycles 30% dip for 25 cycles it is recommended that the on power supply <5% UT(>95% dip in UT) for 5 sec. 100% dip for 5 seconds power mains interruptions, NeedleCam HDTM be powered from an uninterruptible input lines. power supply or battery. IEC 61000-4-11 Power Frequency 3 A/m 3 A/m Power frequency magnetic fields should be at (50/60Hz) levels characteristic of a typical location in a magnetic field typical commercial or hospital environment. IEC 61000-4-8 NOTE: UT is the ac mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration- Electromagnetic Immunity
The NeedleCam HDTM is intended for use in the electromagnetic environment specified below. The customer or the user of the NeedleCam HDTM should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part Conducted RF 3 V rms 10 V rms of the NeedleCam HDTM including cables, than the recommended separation distance IEC 61000-4-6 150 kHz to 80 MHz calculated from the equation applicable to the frequency of the transmitter. outside of ISM bands Recommended separation distance Radiated RF 10 V/m d = (3.5/3) ÖP IEC 61000-4-3 10Vrms d = (3.5/3) ÖP 80 MHz to 800 MHZ d = (7/3) ÖP 800 MHz to 2.5 GHz 150 kHz to 80 MHz Where P is the maximum output power rating of the transmitter in watts (W) according to in ISM bands 10 V/m 80 MHZ to 2.5 GHz
the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range b.
Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the 1080L is used exceeds the applicable RF compliance level above, the NeedleCam HDTM should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the NeedleCam HDTM. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m
Recommended separation distances between portable and mobile RF communications equipment and the NeedleCam HDTM The NeedleCam HDTM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the NeedleCam HDTM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the NeedleCam HDTM as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W) 0.01 0.1 1 10 100
Separation distance according to frequency of transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz 0.035 0.035 0.07 0.11 0.11 0.22 0.35 0.35 0.7 1.12 1.12 2.21 3.5 3.5 7
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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1.5 Warranty Information The BioVision Technologies capital equipment products, NeedleCam HD™ Integrated Visualization System, and the camera head when delivered to the end user in new condition in the original container, is warranted to be free from defects in material or workmanship for one year from the date of shipment from Biovision Technologies, LLC. facility in Golden, Colorado to the end user. The BioVision Technologies Accessory products, Surgical Endoscopes, Hand tools, and Fiber Optic Cables, when delivered to the end user in new condition in the original container, is warranted to be free from defects in material or workmanship for 90-days from the date of shipment from BioVision Technologies, LLC. facility in Golden, Colorado to the end user. Within the above listed time periods, parts that are returned, freight prepaid, to BioVision Technologies LLC ("BioVision Technologies or BioVision") and are determined by BioVision Technologies to be defective will be repaired or replaced by BioVision Technologies without charge for parts, labor, or return ground shipping costs. BioVision Technologies will make every effort to accomplish this repair or replacement within a reasonable time. After the warranty period, you must pay all charges for repair and replacement. This warranty does not cover products intended for single patient use beyond the initial use or consumable items. The above actions by BioVision Technologies shall constitute your exclusive remedy and BioVision Technologies' sole obligation under this warranty. BioVision Technologies shall not be responsible for warranty claims made after the warranty period. To obtain warranty repair service, you must contact Biovision Technologies to obtain a Return Material Authorization ("RMA") number, then return the product, freight prepaid, to BioVision Technologies or to a service facility authorized by BioVision Technologies. The RMA number and a complete explanation of the problem must be included with the product being returned to BioVision Technologies for warranty service. The product to be repaired must be returned in its original box and packaging, or a similar box and packaging affording an equivalent degree of protection. Upon completion of repairs, BioVision Technologies will return the product to the end user, freight prepaid. The warranty period for replacement parts shall begin upon shipment of same, but shall in no event exceed the warranty period of the defective part. BioVision Technologies shall have no liability or obligation for a product that has been subjected to any of the following: failure caused by or attributable to Acts of God, improper use, abuse, negligent care or handling, accident, faulty installation, improper cleaning, improper maintenance, or other indications of excess voltage. This warranty is also void if the product has been repaired or modified without prior written authorization from Biovision Technologies, if the end-user has failed to follow the instructions or heed the warnings or specifications in the Operation and Care Manual, or if the product's serial number has been altered or removed. EXCEPT FOR THE FOREGOING WARRANTIES, BIOVISION TECHNOLOGIES HEREBY DISCLAIMS AND EXCLUDES ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY AND/OR ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. BIOVISION TECHNOLOGIES HEREBY DISCLAIMS ANY REPRESENTATIONS OR WARRANTY THAT THIS PRODUCT OR ANY OF ITS PARTS IS COMPATIBLE WITH NON-BIOVISION TECHNOLOGIES PRODUCTS OTHER THAN VIDEO EQUIPMENT ATTACHED TO ITS VIDEO OUTPUTS, AS DESCRIBED IN THE OPERATOR'S MANUAL. THE LIABILITY OF BIOVISION TECHNOLOGIES, IF ANY, AND PURCHASER'S SOLE AND EXCLUSIVE REMEDY FOR DAMAGES FOR ANY CLAIM OF ANY KIND WHATSOEVER, REGARDLESS OF THE LEGAL THEORY, SHALL NOT BE GREATER IN AMOUNT THAN THE PURCHASE PRICE OF THE PRODUCT SOLD BY BIOVISION TECHNOLOGIES THAT CAUSED ANY ALLEGED DAMAGE. IN NO EVENT SHALL BIOVISION TECHNOLOGIES BE LIABLE TO PURCHASER FOR ANY SPECIAL, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND.
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1.6 How to Use This Manual The intention of this document is to convey the proper and prescribed operation and care of the NeedleCam HD™ 1080L Integrated Visualization System. This manual adheres to a set of conventions to help you easily find the information you need and inform you of important information that will help you efficiently and effectively use your equipment. Sections and sub-sections are noted as follows: 1. Section Title 1.1 Sub-section title Special and important information is called out using notes and warnings. Notes usually pertain to a recommended protocol that will help extend the life of your equipment. Warnings pertain to protocols that delineate appropriate actions which maintain a safe and healthy work environment. Notes and warnings are called out in the following manners: Note: This is a note. WARNING: This is a warning.
1.7 List of Symbols (used in this manual and product labels) Hazard Warning.
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Type BF Applied Part
Attention: Read Operating Manual for Warnings, Precautions, and Instructions for Use.
Not Protected Against the Ingress of Water
Caution - High Voltage
Storage Humidity
Caution - Hot
Transport Temperature
Alternating Current
Federal Communications Commission Mark
Date of Manufacture
WEEE Compliant
UL Testing Laboratories
European CE Mark
AAMI ES60601-1 MEDICAL ELECTRICAL EQUIPMENT, PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE CSA C22.2 NO. 60601-1:08 MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE IEC 60601-1 3RD ED. MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE IEC 60601-2-18 MEDICAL ELECTRICAL EQUIPMENT. PT. 2-18, PARTICULAR REQUIREMENTS FOR SAFETY OF ENDOSCOPIC EQUIPMENT
2. Product Specifications The following section describes the components and features of the NeedleCam HD™ system. 2.1 Contents The following components are included in your NeedleCam HD™ system. These components form the NeedleCam HD™ system and should be treated as ME Equipment per IEC 60601-1. Check to see that you have all of these components before proceeding: NeedleCam HD™ Image Capture Box NeedleCam HD™ Endoscopic Camera Handpiece External Power Supply Operation and Service Manual Applied parts of equipment used in conjunction with this system must be Type BF or Type CF applied parts. If any of these components are missing, contact BioVision Technologies immediately using the contact information below. BioVision Technologies 221 Corporate Circle Suite H Golden, Colorado 80401 USA Phone: 303.237.9608 Fax: 303.237.0757 Email: [email protected]
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2.2 Features and Specifications 2.2.1 NeedleCam HD™ Features Image Capture Box
Figure 2.2.1-A: Image Capture Box
Rear View
Figure 2.2.1-B: Rear View
Keypad Details
Figure 2.2.1-C: Keypad Details
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Camera Handpiece
Figure 2.2.1-D: Handpiece Front Details
Figure 2.2.1-E: Handpiece Basic Functions
Figure 2.2.1-F: Connector Details
NeedleView™ Scope and Camera Handpiece
Figure 2.2.1-G: Handpiece With Scope
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2.2.2 NeedleCam HD™ Technical Specifications Electrical Input voltage: Input current: Power connector: Classification: Mode of operation: Power Supply Input voltage: Input current: Output voltage: Output current: Power connector: Classification: Mode of operation:
5VDC 2.5A maximum. 2.0 mm DC Power Jack IEC60601-1 Class I Continuous
100-240VAC, 50-60Hz (US input voltage)125VAC 3.0-1.5A maximum. 5V DC 4.0A DC 2.0 mm DC Power Jack IEC60601-1 Class I Continuous
Environmental Operating altitude: Operating temperature: Operating humidity: Storage/transport altitude: Storage/transport temperature: Storage/transport humidity:
-304 to 3657m(-1000 to 12000 ft) MSL. 0ºC to 30ºC (-32ºF to 86ºF). 0% to 95% RH, non-condensing. -304 to 10668m (-1000 to 35000 ft) MSL. 0ºC to 50ºC (-32ºF to 122ºF). 0% to 95% RH, non-condensing.
Video Output video format: Video output 1: Video output 2:
RGB 1080i/60 Component Digital 1080i HDMI Compatible
Light Source Type: Power:
LED 1W
MediaCaptureUSB Storage media: Still image file format: Still image size: Video file format: Video size/frame rate:
USB Flash Drive JPEG 1920 x 1080 pixels. H.264 640x480 pixels/30fps.
Compatible Camera Attachments NeedleCam HD™ Camera Hand Piece Product Life
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7 years
2.3 Safety Information General requirements for the safe use of the device: · It is important that you read, understand, and comply with all of the following safety precautions, markings, labeling, and all accompanying literature. · Failure to follow these precautions could result in injury to the patient or user, or damage to the NeedleCam HD™ system. · Before each use, check the outer surface of the endoscope and endoscopically-used accessories to ensure there are no unintended rough surfaces, sharp edges, or protrusions that may cause a safety hazard to the patient or user; or cause damage to the equipment and other accessories. · In the event of use with other surgical tools such as shavers, care shall be taken to avoid damage to the endoscope or any endoscopically used accessories. All damaged instruments shall be discarded immediately. · In the event of a loss of system function during a procedure, no further visualization is necessary and the procedure is ended. The physician shall remove the endoscope and proceed with closure or further patient care as needed. Further endoscopic examination shall only be performed with a fully functional system, for which a backup unit is recommended. · Before each use and after changing viewing modes, ensure that the view observed through the endoscope is the live-not stored-image and that the image has the correct orientation. To avoid personal injury and damage to this device: · Always place and keep the NeedleCam HD™ unit on a flat, level, and secure surface. · In the event of suspected damage or failure, DO NOT OPERATE. Have the device inspected by qualified personnel. · When the NeedleCam HD™ system has reached the end of its useful life, turn the unit in to a local electronics waste recycle center or EEE center, as required by Directive 2012/19/EU. Do NOT dispose of unit in general waste collection. To avoid fire hazard and electrical shock: · DO NOT operate the device outside of the specified input voltage range. · Only use medical-grade power cords with the NeedleCam HD™ system. · Connect to a properly grounded hospital-grade outlet only. · DO NOT operate the NeedleCam HD™ system in an explosive atmosphere (e.g. in the presence of flammable anesthetics, etc.). · The NeedleCam HD™ system does not have any field-replaceable parts. DO NOT disassemble or open covers or panels. Opening the unit will void the manufacturer’s warranty and introduce a risk of shock, injury, or death. · DO NOT operate this product if there are signs of tampering or any of the covers are removed. · DO NOT allow foreign objects inside of the device. · Before performing any kind of maintenance (e.g. cleaning the NeedleCam HD™ system, moving, etc.), always perform the following: · Unplug the power cord. · Do not allow spilling of liquids on the NeedleCam HD™ system. · Do not immerse any of the components in liquids. · Do not operate in wet or damp conditions. · If any maintenance or repair is needed beyond superficial cleaning, contact BioVision Technologies or your authorized service representative.
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To isolate the NeedleCam HD from mains power, unplug the power supply from the wall socket. Always unplug the power cord if: · The device has been exposed to moisture, liquids have been spilled on the device, the device or any of its components have been soaked or immersed in liquids. · The device has been dropped. · The device does not operate properly, the device does not turn on, or the performance of the device is noticeably different. · The device displays signs of tampering or damage, such as damage to the power supply, broken enclosures, etc. WARNING: In the event of use with other energized endoscopically-used instruments and accessories, the PATIENT LEAKAGE currents may be additive. WARNING: Possible explosion if used in the presence of FLAMMABLE ANESTHETICS or other EXPLOSIVE GAS MIXTURES. WARNING: This device is not intended to be used in the presence of HIGH FREQUENCY SURGICAL EQUIPMENT. WARNING: Awareness of the possibility of a gas embolism whenever compressed gases are used in a patient procedure. To minimize the risk, you must verify that adequate space exists for the egress of any patient applied gases. WARNING: DO NOT look directly into the light emitting windows of the endoscope or hand piece. This may result in eye damage. WARNING: Do not touch the light port of the hand piece upon disconnection. The tip of the port may become hot after long periods of use. WARNING: DO NOT IMMERSE the camera handpiece in liquids of any kind, personal injury or damage to the device may result. WARNING: There is a possibility of reciprocal interference for devices sensitive to high levels of light exposure. WARNING: All USB Ports are designed to accept Keyboards, Mice, and USB Flash Drives. Any other devices may introduce the risk of shock, injury, or death. WARNING: No modifications of this equipment are allowed. WARNING: DO NOT point a laser directly into the camera or endoscope. WARNING: The power cord is a tripping hazard. DO NOT route the cord in a way that someone could trip over the cord. WARNING: Products used in conjunction with this system must be type BF or CF. WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
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To avoid electromagnetic interference: · Special precautions are required regarding the electromagnetic compatibility (EMC) of the NeedleCam HD™ system. The system needs to be installed and put into service according to the EMC information provided in this manual. · Portable and mobile radio frequency (RF) communications equipment can affect any medical electrical equipment including the NeedleCam HD™ system. · This device should not be used adjacent to or stacked with other equipment. Should use adjacent to other equipment become necessary the system should be observed to verify normal operation in that configuration. "Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical service department."
3. Setup and Basic Usage The following section describes how to set up and use the NeedleCam HD™ system for surgical procedures. 3.1 Setup Proper initial setup is essential to providing you and your staff the best access to operational and visual performance while conducting procedures. 3.1.1 NeedleCam HD™ System For best performance, always operate and keep the NeedleCam HD™ system on a flat, level, and secure surface. Images on the Video Monitor are best viewed at an angle perpendicular to the display. Do not tilt the NeedleCam HD™ system. 3.1.2 Attaching External Video Devices The NeedleCam HD™ system has connections for multiple video outputs. Any monitor used with this system must have either HDMI or Component RGB connections. The NeedleCam HD™ system can be connected to a standard video monitor with either a Mini HDMI connector or RGB Component connectors. Consult your video monitor manual for the corresponding connections. In order to take full 19
advantage of the benefits offered by our high definition system you will need a monitor capable of displaying a high definition signal.
Figure 3.1.2-A: Video Out Details
To make these connections, plug the connecting cable(s) into the video output(s) on the rear of the NeedleCam HD™ and the corresponding video input(s) of the external devices. Note: In order to output a specific signal, turn the power off and the “signal selection switch” at the back of the device should be slid toward the signal label that you are wanting to output (e.g. for Digital output, the switch should be to the left “DIGITAL” side)(HDMI). The power can then be turned on. Note: The system will only export one video signal at a time. If the switch is to the left “DIGITAL” side, only the high definition signal will be exported. If the switch is to the right “COMPONENT” side, only the component signal will be exported.
3.1.3 Attaching a Camera Handpiece and Endoscope The camera handpiece attaches via a PCB electric connector. This connector seats in the receptacle on the front of the unit (See also: § 2.2.1-F Connector Details). Before connecting a camera handpiece to the NeedleCam HD™ system, the camera hand piece must be appropriately cleaned. Note: For best image quality and to ensure patient safety, verify that both ends of the camera hand piece are free of foreign particles.
Connecting the hand piece to the NeedleCam HD™ system: The connector assembly fits into the port in only one orientation. Insert the connector assembly into the port until the retention tab clicks into place and the Release Button pops up. 20
Figure 3.1.3-A: Connector Insertion Details
Figure 3.1.3-B: Scope Attachment Details
Connect the scope to the camera by pulling the sliding sleeve and inserting the scope. Ensure that the light port is aligned with the bottom of the camera. Release the sliding sleeve to secure the scope in place. The proper technique must be utilized in order to preserve the sterile field through the drape that is attached to each endoscope. See instructions in section 3.1.4 for the proper procedure for attaching a scope while maintaining the sterile field. 3.1.4 Attaching a Sterile Scope Within the Sterile Field Attaching a sterile scope while preserving the sterile field requires two people. One person remains outside the sterile field and one person remains inside the sterile field. The non-sterile person holds the camera hand piece and pulls back the sliding sleeve. The sterile person takes the scope from the sterile packaging and inserts the back end into the camera hand piece while the sliding sleeve is pulled back. After proper alignment and connection has been achieved, the non-sterile person grabs the two white tabs on the end of the sterile drape and pulls both tabs down the hand piece and connection cable until the drape has been completely unfolded. After the drape has been unfolded, the sterile person can now handle the camera hand piece and remain 21
inside the sterile field. Once the scope is attached and the drape is pulled into place, continue with the rest of the setup procedure.
Figure 3.1.4-A: Sterile Scope Attachment Details
3.1.5 Focussing The Camera
Figure 3.1.5-A: Focus Details
Turn the power on. The system will take about 30 seconds to power on and load the software. Hold the distal tip of the scope approximately 1.0 cm from a surface with fine details such as your palm or surgical drape. Turn the focus adjustment knob in either direction until the fine-detailed surface at the distal end of the scope comes into optimal focus on the video monitor. There are rotating limits at both the minimum and maximum focussing limits. If one of the limits has been hit and the image has not focused, rotate the focus knob in the opposite direction until the image comes into focus. See also: § 3.2.1 Setup for Each Procedure 3.2 Basic Usage The NeedleCam HD™ Integrated Visualization System is indicated to be used in diagnostic and operative arthroscopic 22
and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, shoulder, temporomandibular joint (TMJ), spinal, opthalmic, ear/nose/throat (ENT), and the cervix. 3.2.1 Setup for Each Procedure Ensure that the power supply being used is the one that is supplied with each system. Connect the supplied power supply to the NeedleCam HD™ system. Connect the other end of this supply to a power outlet that has also been approved for medical use. Position the equipment so that the power plug is easily accessible and can be easily un-plugged. It is important to keep the system including the monitor out of the reach of the patient to avoid the patient experiencing harmful leakage currents. Turn on the NeedleCam HD™ system by pressing the Power button (on the back of the unit to the right of the power cord plug in). Approximately thirty (30) seconds later, the software will activate in “Live Mode.” Note: These instructions are for basic usage of the NeedleCam HDTM system. Refer to section 1.2 for the “Indications for Use”. Note: More specific instructions on the functionality of “The Software,” can be found in section 4
To store picture/video files, insert the USB flash drive into one of the USB ports. When the drive is successfully connected the USB symbol on the screen will change to indicate the system is ready to store image files. Note: Files will only be stored to the first drive that is plugged in. Note: Do Not plug in a USB Hub into any of the USB ports.
3.2.2 Power-Down Procedures When you are finished using the NeedleCam HD™ system, turn off the system. Always disconnect the NeedleCam HD™ system from its power source when performing any kind of maintenance (e.g. cleaning, etc.). Please refer to section 5 for proper cleaning and maintenance instructions
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