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iii 

Declarations of Conformity 

Legal Statement 

NDS may sell its products through other medical device manufacturers, distributors and resellers and therefore, purchasers of this NDS product should 
consult with the entity through which this product was originally purchased regarding the terms of any applicable product warranties provided by such 
entity, if any. 
 
NDS neither assumes nor authorizes any person to assume for it any other liabilities in conjunction with and/or related to the sale and/or use of its 
products. To ensure proper use, handling and care of NDS products, customers should consult the product specific literature, instruction manual, and/or 
labeling included with the product or otherwise available. 
 

 

Customers are cautioned that system configuration, software, the application, customer data and operator control of the system, among other factors, 
affect the product’s performance. While NDS products are considered to be compatible with many systems, specific functional implementation by 
customers may vary. Therefore, suitability of a product for a specific purpose or application must be determined by the consumer and is not warranted 
by NDS. 

 

NDS SPECIFICALLY DISCLAIMS ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS, IMPLIED AND/OR STATUTORY, INCLUDING, BUT NOT LIMITED TO 
WARRANTIES OF MERCHANTABILITY, FITNESS AND/OR OF SUITABILITY FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT WITH RESPECT TO ALL 
NDS PRODUCTS OR SERVICES. ANY AND ALL OTHER WARRANTIES, REPRESENTATIONS AND/OR GUARANTEES, OF ANY TYPE, NATURE OR EXTENT, BE IT 
IMPLIED, EXPRESS AND/OR WHETHER ARISING UNDER OR AS A RESULT OF ANY STATUTE, LAW, COMMERCIAL USAGE, CUSTOM, TRADE OR OTHERWISE, 
ARE HEREBY EXPRESSLY EXCLUDED AND DISCLAIMED.  

 

NDS, its suppliers and/or distributors are not liable, directly or by way of indemnity for any special, incidental, consequential, punitive, exemplary or 
indirect damages, including but not limited to alleged damages for delayed shipment, non-delivery, product failure, product design or production, 
inability to use such products or services, loss of future business (lost profits), or from any other cause, whatsoever, in connection with or arising from 
the purchase, sale, lease, rental, installation or use of such NDS products, these terms and conditions, or with respect to any the terms of any agreement 
which incorporates these terms and conditions. 
 

 

SOME JURISDICTIONS DO NOT ALLOW EXCLUSIONS AND DISCLAIMERS OF CERTAIN WARRANTIES OR LIMITATIONS OF LIABILITY, SO THE LIMITATIONS 
AND/OR EXCLUSIONS, SET FORTH HEREIN, MAY NOT APPLY. IN THAT EVENT LIABILITY WILL BE LIMITED TO THE GREATEST  EXTENT PERMITTED BY LAW 
IN THE SUBJECT JURISDICTION. 

 
The information provided in this document, including all designs and related materials, is the valuable property of NDS and / or its licensors and, as 
appropriate, they reserve all patent, copyright, and other proprietary rights to this document, including all design, manufacturing reproduction, use, 
and sales rights thereto, except to the extent said rights are expressly granted to others.  

FCC and Council Directives of European Standards: 

This device complies with Part 15 of FCC rules and 93/42/EEC of the Council Directives of European Standards Directive as amended by 2007/47/EC. 
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 undesirable results.  
1. 

Use the specified cables with this device so as not to interfere with radio and television  reception.  Use of other cables and / or adapters may cause 
interference with other electronic equipment. 

2. 

This equipment has been tested and found to comply with the limits pursuant to FCC part 15 and CISPR 11.  This equipment generates, uses and 
can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio 
communications. 

IEC: 

This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2. These limits are designed to provide 
reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency 
energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.  
 

FCC, Council Directives of European Standards and IEC: 

There is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television 
reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of 
the following measures: 

• 

Reorient or relocate the receiving antenna. 

• 

Increase the separation between the equipment and receiver. 

• 

Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. 

• 

Consult your dealer or an experienced radio/TV technician for help. 

Accessory equipment connected to this product must be certified according to the respective IEC Standards (i.e., IEC 60950-1) for data processing 
equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard, IEC 60601-1-1. Anyone  who 
connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system 
complies with the requirements of system standard IEC 60601-1-1. Whoever is responsible for securing the unit to a system needs to insure that the 
mounting equipment used with this product complies to IEC standard 60601-1. If in doubt, consult the technical services department or your local 
representative.  

Содержание ExpandOR

Страница 1: ...ExpandOR Medical Grade Video Streaming System USER MANUAL ENGLISH ...

Страница 2: ......

Страница 3: ...without notice NDS provides this information as reference only Reference to products from other vendors does not imply any recommendation or endorsement This document contains proprietary information protected by copyright No part of this manual may be reproduced by any mechanical electronic or other means in any form without prior written permission of NDS All trademarks are the property of their...

Страница 4: ......

Страница 5: ...ifications 2 Section 3 ExpandOR Connections 3 Cable Bend Radius 3 Section 4 Transmit 4 Section 5 Receive 5 Section 6 Simultaneous Transmit Receive 6 Section 7 Transmitting to Multiple Locations 7 Audio Setup 7 Section 8 Privacy Feature 8 Record and Capture Features 9 Record Video Feature 9 Capture Still Feature 9 Section 9 Configuration Options 10 Cleaning Instructions 11 Electromagnetic Compatibi...

Страница 6: ...No modifications are allowed This equipment system is intended for use by healthcare professionals only Safety Compliance This product is T U V approved with respect to electric shock fire and mechanical hazards only in accordance with CAN CSA C22 2 NO 60601 1 and ANSI AAMI ES60601 1 Safety Compliance This product meets the requirements of EN60601 1 so as to conform to the Medical Device Directive...

Страница 7: ...s appropriate they reserve all patent copyright and other proprietary rights to this document including all design manufacturing reproduction use and sales rights thereto except to the extent said rights are expressly granted to others FCC and Council Directives of European Standards This device complies with Part 15 of FCC rules and 93 42 EEC of the Council Directives of European Standards Direct...

Страница 8: ......

Страница 9: ...tup by the IT Department a doctor or a nurse in the operating room can easily Initiate streaming and or capturing session Enable privacy in compliance with security requirements such as HIPAA End streaming session NDS recommends that the installation and initial setup is done by the hospital s IT department by a technician with a basic understanding of networking including an understanding of TCP ...

Страница 10: ...etworking including an understanding of TCP IP Protocol IP Address Gateway Subnet Mask Network Port Pinging a device on the same network configuring a laptop to work in a corporate hospital network For mission critical applications we strongly recommend that a replacement unit be immediately available Specifications are subject to change without notice Contact factory for current specifications DC...

Страница 11: ...hone must be connected to the IN MIC connector and headphones or an amplified speaker must be connected to the OUT LINE connector Additionally Options 1 or 2 above must be implemented The diagram below shows the devices that may be connected to the ExpandOR The unit s application will determine which of these devices is required The devices required for a given function are described in the Connec...

Страница 12: ...until the LED below it turns on Turn privacy off by pressing the PRIVACY button until the LED turns off See page 8 for more on PRIVACY 5 Pressing the CAPTURE STILL button as shown below captures a video frame as a still image saved to the USB drive The CAPTURE STILL LED flashes once during the capture See page 9 for more on the CAPTURE STILL function 6 Press the TRANSMIT button again to end transm...

Страница 13: ... pressing the RECEIVE button as shown in Step 2 above The RECEIVE LED turns off If vid eo was being recorded ending receive also ends video recording and the RECORD VIDEO LED is turned off 3 If you want to record the video stream and or capture images verify with your IT department that the ExpandOR is setup for video streaming and or capturing images If it is then proceed as shown below Start rec...

Страница 14: ... 2 above Stop receiving by pressing the RECEIVE button as shown in Step 3 The TRANSMIT LED and the RECEIVE LED turn off If video was be ing recorded ending receive also ends video recording turning off the RECORD VIDEO LED If you want to record the video stream and or capture images verify with your IT department that the ExpandOR is setup for video streaming and or capturing images If it is then ...

Страница 15: ...tment can set it up if required When the ExpandOR has been configured for broadcasting press the TRANSMIT button shown below to begin broadcasting to destinations defined in the ExpandOR configuration 7 Audio Setup The ExpandOR can be configured to transmit and receive audio with its surgical video stream If your application requires audio your IT department can configure the ExpandOR to support a...

Страница 16: ...he screen shown below and audio will be muted Privacy is enabled or disabled by pressing the PRIVACY button on the front panel When Privacy Mode is on the LED below the PRIVACY button will be on When the Privacy Mode is off the LED will be off Note HIPAA is the Health Insurance Portability and Accountability Act which sets the standard for protecting sensitive patient data 8 ...

Страница 17: ... images are saved as a jpg files and are stored in the Image folder of the installed USB drive No additional action by the user is required Note The capture feature may be configured to capture frames from either the output video stream or Record Video Feature 1 A USB drive must be installed in the USB connector on the back of the ExpandOR before using this feature USB drives must be USB 2 0 or be...

Страница 18: ...y the device with which it is communicating The table below each device shows direction parameters for device combinations From ExpandOR Signal Direction Transmit Yes Receive Yes Both Yes Signal Direction Transmit Yes Receive Yes Both Yes To ExpandOR Signal Direction Transmit Yes Receive No Both No Signal Direction Transmit No Receive Yes Both No From ExpandOR To PC ...

Страница 19: ...lint free cloth dampened with 80 Ethyl Alcohol Allow the unit to air dry Cautions Do not allow liquids to enter the interior of the unit and do not permit exterior surfaces to come into contact will unacceptable solvents such as those listed below as severe damage to the unit may result Acceptable Cleaning Materials Vinegar distilled white vinegar 5 acidity Ammonia based glass cleaner Acceptable D...

Страница 20: ...or to a surgical procedure The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals CISPR 11 class A If it is used in a residential environment for which CISPR 11 class B is normally required this equipment might not offer adequate protection to radio frequency communication services The user might need to take mitigation measures such as relocatin...

Страница 21: ...are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The product is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC...

Страница 22: ...se in the electromagnetic environment specified below The customer or the user of the product should assure that it is used in such an environment Immunity Test Immunity Test Electrostatic discharge ESD IEC 61000 4 2 2 4 6 8kV contract discharge 2 4 6 8 15 kV air discharge Radiated RF field IEC 61000 4 3 3 V m 80 MHz 2 7 GHz 80 AM 1 kHz Proximity fields from wireless transmitters IEC 61000 4 3 80M...

Страница 23: ...t 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 ...

Страница 24: ......

Страница 25: ...ing Germany 49 89 31 707 100 info novanta europe novanta com Asia Pacific Novanta Japan East Square Omori 6 20 14 Minamioi Shinagawa ku Tokyo 140 0013 Japan 81 3 5753 2466 info ndssi com Oriental Media Center Suite 2302 Tower C No 4 Guang Hua Road Chao Yang District Beijing 100026 China 86 10 8559 7859 info ndssi com NDS Quality System ISO 13485 FDA Registration 2954921 ...

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