nox W7 LINK User manual

NOX W7 LINK KITS
Instructions for Use
Introduction
The Nox W7 LINK KITs come in three different versions and can be
used with the Nox recording devices when configured for an ambulatory
study. Note there is a slight difference in the configuration dependent on
if the Nox T3 recorder or Nox A1 recorder is used (Refer to section
Instuctions for Use).
•Nox W7 LINK KIT - A
To be used with:
• Resmed AirSense™10
• Nox W7 LINK KIT - R
To be used with:
• Radiometer TCM4, TCMCombiM, TCM40, TCM TOSCA
• Nonin RespSense
• Resmed S9™
• Nox W7 LINK KIT - S
To be used with:
• SenTec Digital Monitor (Software SMB07.0x and SMB08.00)
The Nox W7 LINK KIT packages include:
• Nox W7 LINK (Uncord Serial Port Plug F2M01SXA)
• Power Adapter (FW7721M/05)
• USA Plug Adapter
• European Plug Adapter
• UK Plug Adapter
• Nox USB Mini Cable
• DB9 Male to Male Mini Null Modem
• Nox User Instruction Leaflet
Intended Use
The Nox W7 LINK is a Medical Device Data System (MDDS) and allows for
electronic conversion and wireless transfer of medical device data between
an auxiliary medical device and a Nox recording device. The Nox W7 LINK
is connected to a serial port of an auxiliary medical device. Before the data
is transmitted over Bluetooth® link to the applicable Nox recording device
it is converted from serial to Bluetooth format.
Scope
This leaflet is designed to instruct users on how to use the Nox W7
LINK with supported auxiliary devices.
Warnings and Cautions
• Warning: Do not use damaged equipment, sensors or accessories.
This may result in bad performance of the Nox W7 LINK or patient/
operator injury.
• Warning: The Nox W7 LINK is not certified to be used for continuous
monitoring where failure to operate can cause injuries or death of the
patient.
• Warning: The RF function of the Nox W7 LINK might influence the
performance of other devices in close proximity and lead to potential
serious harm.
• Warning: Only use the medical grade power adapter provided by Nox
Medical as part of the Nox W7 LINK KIT package to power the Nox W7
LINK. The use of other power adapters may result in electric shock or
overheating of the power adapter/burns.
• Warning: Use of the Nox W7 LINK with auxiliary devices that have not
been validated by Nox Medical may result in electric shock. Always use
the Nox W7 LINK with validated auxiliary devices. Auxiliary devices need
to comply with applicable IEC 60601-1 safety standards for medical
electrical equipment.
• Warning: Do not use the Nox W7 LINK KITs in a Magnetic Resonance
Imaging (MRI) environment. That might lead to serious patient harm.
Instructions for Use
1. Preparing a Study with the Nox W7 LINK
When configuring a Nox recording device for an ambulatory study with the
Nox W7 LINK in the Noxturnal software, the applicable Nox W7 LINK is
added by entering its Bluetooth address in the relevant field. Two different
addresses are used, depending on if the Nox A1 recorder is being used or
the Nox T3 recorder:
Nox A1 Recorder: The Nox W7 LINK’s Bluetooth address (BDA) is used and
has 12 digits. The BDA can be found on the Nox W7 LINK’s label.
Nox T3 Recorder: The Nox W7 LINK’s serial number (SN) is used and has 9
digits. The SN can be found on the Nox W7 LINK’s label.
2. Connecting to a Resmed S9™/AirSense™10 Device
The Nox W7 LINK is connected to the serial interface output located on
the Resmed Embletta Adapter. The Nox W7 LINK has thumbscrews which
can be used for more secure placement. For thumbscrews use a 4mm flat
screwdriver.
Note: The supported modes are AutoSet and CPAP.
3. Connecting to a Radiometer Device
The Nox W7 LINK KIT - R includes a DB9 male to male mini null modem.
Connect the null modem to the Nox W7 LINK, use thumbscrews for secure
placement. For thumbscrews use a 4mm flat screwdriver.
Connect the applicable serial port extension cable (available from
Radiometer) to the Radiometer device and connect the Nox W7 LINK
to the serial interface located on the extension cable.
4. Connecting to a Nonin RespSense Device
The Nox W7 LINK KIT - R includes a DB9 male to male mini null modem.
Connect the null modem to the Nox W7 LINK. Connect the Nox W7 Link
to the serial interface output located on the side of the Nonin RespSense.
Use the thumbscrews for secure placement. For thumbscrews use a
4mm flat screwdriver.
5. Connecting to SenTec Digital Monitors
The Nox W7 LINK KIT - S includes a DB9 male to male mini null modem.
The null modem is connected to the serial interface output located at the
back of the SenTec device. Connect the Nox W7 LINK to the null modem.
Use thumbscrews for more secure placement. For thumbscrews use a 4mm
flat screwdriver.
6. Starting a Study
a. Connect the Nox W7 LINK to the applicable auxiliary device as instructed
above (Step 2, 3, 4 or 5) and make sure the Nox Mini USB cable is
connected to the NOX W7 LINK and the Power Adapter (FW7721M/05).
b. Turn on the auxiliary device. The blue LED on the link starts blinking.
c. Turn on the Nox recording device.
d. The green LED on the NOX W7 LINK starts blinking, indicating Bluetooth
connection with the Nox recording device.
Note: Establishing Bluetooth connection may take up to 2 minutes.
e. Now a Bluetooth connection has been established between the Nox
recording device and the auxiliary device. The auxiliary device’s signals
are being recorded.
States of the Nox W7 LINK ’s LEDs
The NOX W7 LINK is equipped with two LEDs. The green LED indicates the
status of the transmission. It blinks when the device is communicating with
the Nox recording device. It is steady when the device is on standby. The
blue LED indicates that the auxiliary device is streaming data to the device.
Maintenance
When the Nox W7 LINK is not in use, disconnect it from auxiliary
devices and store in a dry place.
Environmental Conditions
Operation:
Temperature: 0 °C to +40 °C (+32 °F to +104 °F)
Relative Humidity: 15-95% (non-condensing)
Atmospheric Pressure: 700 hPa - 1060 hPa
Storage:
Temperature: -20 °C to +70 °C (-4 °F to +158 °F)
Relative Humidity: 10-95% (non-condensing)
Atmospheric Pressure: 700 hPa - 1060 hPa
Cleaning
The Nox W7 LINK tolerates cleaning with a soft cloth moistened with a
mild soap solution.
Technical Specifications
Nox W7 LINK
• Physical Size: 36x17x60 (WxHxL) mm
• Voltage Range: 5-30V DC
• Current Consumption (max): 300mA
• Baud Rate: Configured up to 230400 baud/s
• Operating Frequency: 2402-2480 MHz
• Transmit Power: -8 to 16 dBm
• Sensitivity at 0.1% BER: -90 dBm
• Range: 10m in line of sight when used with Nox recording devices
Mini Null Modem
• DB9 Male to Male Mini Null Modem Adapter
Power Adapter (FW7721M/05)
• Input voltage 100 to 240 V AC (± 10%)
• Input current 200 to 100 mA
• Frequency 50 to 60 Hz
• Efficiency 80% typ. at full load
• Output 5V DC/1.5A
• Exchangeable plug system: European, UK, USA
Nox USB Mini Cable
• Mini-B plug
• Standard-A plug
Disposal
According to the regulation in Europe on
Waste of Electrical and Electronic
Equipment (WEEE) the equipment may not
be disposed of as unsorted municipal waste.
The equipment shall be collected separately
and returned to the appropriate collection
system available. Please contact your
sales representative regarding take-back or
recycling of the equipment.

Descriptions of Symbols and Labels
(01)1569431111XXXX
(11)YYMMDD
(21)WWWWWWWWW
(01)1569431111XXXX
(11)YYDDMM
(10)ZZZZZZ
Copyright Notice
No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system,
or translated into any language or computer language, in any form, or by any means: electronic,
mechanical, magnetic, optical, chemical, manual, or otherwise, without the prior written
authorization from Nox Medical.
Disclaimer
This document may contain typographical errors or technical inaccuracies. Nox Medical does not
accept any liability for the use or misuse whether direct or indirect of the products, or for damages
arising out of the use of or inability to use the products. Users must accept all responsibility for any
results obtained by or concluded from data obtained by the products including software from Nox
Medical. All clinical conclusions and decisions that are based on the use of this product are the
responsibility of the user.
For distributor information go to: www.noxmedical.com
Reference number for Nox W7 LINK KIT - A is 54 40 12
Reference number for Nox W7 LINK KIT - R is 54 40 11
Reference number for Nox W7 LINK KIT - S is 54 40 10
Kitted by:
Nox Medical ehf
Katrinartuni 2
IS-105 Reykjavik
Iceland
www.noxmedical.com
Nox W7 LINK KITS
Instructions for Use
Certifications
The Uncord Serial Port Plug F2M01SXA is certified according to CE and
FCC regulations and is fully Bluetooth® certified as an end product
(QDID: B012540).
Uncord Serial Port Plug F2M01SXA complies with the requirements of
R&TTE Directive 1999/5/CE, the European Community Directive 73/23/EEC
and 93/68/EEC
• EN 300 328
• EN 301 489-1/-17
• EN60950
The power adapter (FW7721M/05) conforms to the following EMC
standards:
• EN 55011, EN 55022/ B
• IEC 60601-1-2
• FCC 47 Part 15
• EN 61000-3-2, EN 61000-4-2, EN 61000-4-3, EN 61000-4-4,
EN 61000-4-5, EN 61000-4-6, EN 61000-4-11
The power adapter (FW7721M/05) fulfils class II, SELV according to the
following standards:
• ES 60601
• IEC 60601-1
• UL 2601
• Fulfills medical application class B / BF / CF
FCC Information
This Uncord Serial Port Plug F2M01SXA has been tested and found to
comply with the limits for a Class B digital device, pursuant to Part 15 of
the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential 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 radio communications. However, 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 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 the dealer or an experienced radio/TV technician for help
FCC Caution: Any changes or modifications not expressly approved by the
party responsible for compliance could void the user's authority to operate
this equipment. 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.
IMPORTANT NOTE:
Radiation Exposure Statement: The Uncord Serial Port Plug F2M01SXA
complies with FCC radiation exposure limits set forth for an uncontrolled
environment. End users must follow the specific operating instructions for
satisfying RF exposure compliance. To maintain compliance with FCC RF
exposure compliance requirements, please follow operation instruction as
documented in this manual.
This transmitter must not be co-located or operated in conjunction with
any other antenna or transmitter. Highest reported body SAR is:
0.581W/kg.
FCC ID: R47F2M01SX
10%
95%
1060hPa
-20°C
+50°C
700hPa
Operating instuctions /Consult instructions for use
Manufacturer information
Date of manufacture
Serial number
Catalouge number / Reference number
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
Keep dry
Fragile, handle with care
Unique Device Identifier (UDI): Application Identifier (01)
represents the device identifier (DI) (“1569431111XXXX”),
the Application Identifier (11) the production date/date of
manufacture (“YYMMDD”, with “YY” the last two digits of the
production year, “MM” the production month and “DD” the
production day), the Application Identifier (21) the serial number
of the device (“WWWWWWWWW”) if applicable, and the Application
Identifier (10)ZZZZZZ the lot number of the device (“ZZZZZZ”) if
applicable
In compliance with the European Directive on Waste of Electrical
and Electronical Equipment (WEEE) 2002/96/EC, do not dispose
of this product as unsorted municipal waste
NOX-BT1LEA-0101-REV2
Last issued: January 2017
Copyright ©2017 Nox Medical - All rights reserved
Batch code / Lot number
Federal Communication Commission (FCC) logo
CE marking indicating conformance to EC directives 93/42/EEC and
2007/47/EC concerning medical devices
Bluetooth
® wireless technology