Capsule Technologie 002 SmartLinx Neuron 2 User Manual IandM Neuron 2

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SmartLinx Neuron 2
Hardware
Installation and
Maintenance Guide
Copyright ©2014 Capsule Technologie.
DC-NU2-IM-DOC
2.0
August 22, 2014
Legal Notice
English
Copyright © 2014 Capsule Technologie. All rights reserved.
This product and related documentation are protected by copyright and distributed under licensing
restricting their use, copying, distribution, and decompilation. No part of this product or related
documentation may be reproduced in any form or by any means without prior written authorization of
Capsule Technologie.
Trademarks
SmartLinx Administrator, SmartLinx Axon, SmartLinx Chart Xpress, SmartLinx Client, SmartLinx ESP,
SmartLinx IQ, SmartLinx Medical Device Information System, SmartLinx Neuron, SmartLinx Vitals Plus,
SmartLinx Vitals Stream, and related marks, images, and symbols are the exclusive properties of Capsule
Technologie.
Adobe Acrobat is a trademark of Adobe Systems, Inc.
DISPATCH® is a registered trademark of Caltech Industries, Inc.
Clorox® is a registered trademark and Clorox Healthcare™ is a trademark of the Clorox Company.
Sani-Cloth® is a registered trademark of PDI, Inc.
Corepoint Integration Engine is a trademark of Corepoint Health.
Intel, Dual Core, and Pentium are trademarks or registered trademarks of Intel Corporation.
Windows, Framework .NET, Message Queuing, MSMQ, Internet Explorer, XP, Hyper-V, Server 2003 and
Server 2008 are trademarks or registered trademarks of Microsoft.
Contents
English
Chapter 1: Introducing the SmartLinx Neuron 2
Overview
Intended Use
About this document
Product designation in this document
Purpose
Audience
Notes, cautions, warnings
Related documents
Manufacturer’s Information
Distribution and Service
Table of abbreviations
Chapter 2: Setting up the SmartLinx Neuron 2
What’s in this chapter
Unpacking and inspecting the package contents
Contents of a product shipment
Unpacking the cartons
Hardware installation prerequisites
Installing the batteries in the SmartLinx Neuron
Installing the main battery in the SmartLinx Neuron
Installing the optional extended battery in the SmartLinx Neuron
Deploying the SmartLinx Neuron
Precautions for all deployments
Considerations for wall-mounted deployments
Mounting the SmartLinx Neuron on the wall
Mounting the SmartLinx Neuron on a roll stand
Connecting the SmartLinx Neuron to the power supply
Power requirements
Connecting the SmartLinx Neuron to the power supply
Before you use the SmartLinx Neuron for the first time
Chapter 3: Operating the SmartLinx Neuron 2
Components on the SmartLinx Neuron
Connectivity
Serial Ports
USB Ports
Ethernet Port
Powering on the SmartLinx Neuron
Power on the SmartLinx Neuron
Power Off the SmartLinx Neuron
Working with the SmartLinx Neuron touch screen
Reading the status LED
Working with the batteries
Battery Lifetime Terminology
Battery Summary
Table of Contents
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English
Charging the batteries
Removing a battery
Swapping a battery
Connecting the SmartLinx Neuron to the network
Connecting a vital signs monitor to the SmartLinx Neuron
Before you connect
Connecting the cables
Connecting the devices
For more on using the SmartLinx Neuron with the vital signs monitor
Chapter 4: Maintaining the SmartLinx Neuron 2
Periodic cleaning and disinfection
Cleaning Precautions
Periodic maintenance of the SmartLinx Neuron
Authorized Access
Inspections
Storing the SmartLinx Neuron
Maintenance of the SmartLinx Neuron batteries
Cleaning
Short-term maintenance
Long-term storage and maintenance
Chapter 5: Technical Information
Guidance and manufacturer’s declaration
SmartLinx Neuron technical specifications
Device Identification Module (DIM) technical specifications
Regulatory Information
Explanation of Device and Packaging Symbols
Safety and Regulatory Compliance
EN/IEC
Federal Communications Commission
CE Declaration
Industry Canada statement
RoHS and WEEE Compliance
Recycling and the Environment
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Table of Contents
Introducing the SmartLinx Neuron 2
English
Overview
The SmartLinx Neuron 2 is Capsule's point-of-care hardware platform for device connectivity. It is a
flexible and scalable platform that you can configure to operate in various care areas of the hospital. In
high acuity environments, such as the ICU, the SmartLinx Neuron 2 typically runs Capsule’s Vitals
Stream Application to enable continuous collection of vital signs for one patient from multiple devices.
In low acuity, non-critical care settings (such as med-surg), the SmartLinx Neuron 2 typically runs
Capsule's Chart Xpress Application to enable the automatic collection, validation, and transmission of
vital signs from multiple patients to the EMR directly from the point of care.
Note: Do not operate the SmartLinx Neuron 2 until after you read and understand these instructions.
Pay particular attention to all warnings and cautions.
Note: For information about the administration of SmartLinx MDIS software, IT personnel should
refer to the SmartLinx MDIS System Administrator’s Guide.
Note: To operate the SmartLinx Neuron 2, clinicians require training in the procedures described in
the Clinical User’s Guide for SmartLinx Chart Xpress on Neuron and the Clinical User’s Guide for
SmartLinx Vitals Stream on Neuron.
Note: To operate any medical device that connects to the SmartLinx Neuron 2, clinicians must be
separately trained in the use of that device.
Intended Use
The intended use of the SmartLinx MDIS system is for data collection and clinical information
management, either directly or through networks with independent bedside devices.
Capsule's hardware and software are not intended for monitoring purposes, nor is the software
intended to control any of the clinical devices (independent bedside devices/information systems) to
which it is connected. There is no other known contraindication for the use of the SmartLinx Neuron 2
system.
Caution: Do not modify the SmartLinx Neuron 2, cables, or any part of the SmartLinx MDIS
software, or mount the device in any way other than instructed in Capsule documents.
Any modification to the hardware or software can prevent proper functioning and cause
damage to the connected medical device.
Introducing the SmartLinx Neuron 2 [Chapter 1]
About this document
English
Product designation in this document
The product described in this document is the “SmartLinx Neuron 2” (part number: DC-NU2-UMPC). For
brevity and clarity, that product is referred to in the rest of this document as the “SmartLinx Neuron”.
This means that all references to “SmartLinx Neuron” in this document shall be understood as applying
to part number DC-NU2-UMPC.
Purpose
This document provides:
• instructions for installing, mounting, and connecting the SmartLinx Neuron hardware
• instructions for maintaining, cleaning, and storing the device and its accessories
• details of technical characteristics and regulatory compliance of the device
Audience
The target audiences for this document are:
Audience
Description
Biomedical staff The biomedical staff ensures that the medical equipment is safe, functional, and properly
configured for the clinical environment. They install, inspect, and maintain biomedical devices
and support systems to adhere to medical standard guidelines.
Clinicians
Clinicians are health care providers who interact with patients in a medical environment, such
as a registered nurse, nurse technician, respiratory therapist, or anesthesiologist.
Notes, cautions, warnings
Where necessary, Capsule documents highlight any applicable warnings, cautions, and notes to avoid
risk of injury to individuals or damage to equipment. There are three levels of information:
Warning:
Indicates a hazard with a medium level of risk which, if not avoided, could result in
death or serious injury.
Caution:
Indicates a hazard with a low level of risk which, if not avoided, could result in minor or
moderate injury or severe damage or malfunctioning of the equipment.
Note:
Directions to clarify specific information to assist the user, and to avoid the risk of damage
to the equipment described in this guide and/or any other equipment or goods, and/or
cause environmental pollution.
Introducing the SmartLinx Neuron 2 [Chapter 1]
Related documents
Capsule provides the following additional documents for use with the SmartLinx Neuron.
Document
Audience
English
SmartLinx MDIS System
Administrator's Guide
(English only)
Description
provides information on deployment scenarios and instructions Hospital IT staff
on how to install, upgrade, and configure the SmartLinx Medical
Device Information System software solution, including
troubleshooting tips.
Available from the:
• Help menu of the SmartLinx Neuron Manager
• Capsule Customer Portal
Clinical User's Guide for
Vitals Stream on Neuron
provides information on how to use the Vitals Stream
application, along with troubleshooting advice and hardware
cleaning instructions.
Available from the:
Clinicians
• Help menu of the SmartLinx Neuron Manager
• Capsule Customer Portal
• Help icon in the application
Clinical User's Guide for
Chart Xpress on Neuron
provides information on how to use the Chart Xpress
application, along with troubleshooting advice and hardware
cleaning instructions.
Available from the:
Clinicians
• Help menu of the SmartLinx Neuron Manager
• Capsule Customer Portal
• Help icon in the application
Manufacturer’s Information
Capsule Technologie SAS
9 Villa Pierre Ginier
75018, Paris France
Phone: (+33) 1 5334 1400
Introducing the SmartLinx Neuron 2 [Chapter 1]
Distribution and Service
English
For more information, or to order additional products (SmartLinx Neurons, or accessories including
batteries, power cables, printed copies of documents), contact your reseller or Capsule directly:
USA
EMEA & APAC
Capsule Tech, Inc.
Capsule Technologie
300 Brickstone Square, Suite 203
Andover, MA 01810 USA
Phone: 1-978-482-2300
Toll Free: 1-800-260-9537
9 Villa Pierre Ginier
75018, Paris France
Phone: (+33) 1 5334 1400
Technical Support in North America
Technical Support outside North America
Phone: 1-800-260-9537
E-mail: support@capsuletech.com
Phone: (+33) 1 8417 1200
E-mail: emea.support@capsuletech.com
Table of abbreviations
The table provides an alphabetical list of the main abbreviations used in this document.
Abbreviation
Meaning
AC
Alternating Current
CE
Conformité Européenne (= European Conformity)
CISPR
Comité International Spécial des Perturbations Radioélectriques
(= Special international committee on radio interference)
DIM
Device ID Module
DTS
DataCaptor Terminal Server
EN/IEC
European Norm / International Electrotechnical Commission
FCC
Federal Communications Commission
GB
Gigabyte
LAN
Local Area Network
LED
Light Emitting Diode
MVP
Mobile Vitals Plus
RoHS
Restriction of the use of Hazardous Substances
VAC
Voltage in Alternating Current
WEEE
Waste Electrical and Electronic Equipment Directive
WLAN
Wireless Local Area Network
WPA
Wireless Protected Access
Introducing the SmartLinx Neuron 2 [Chapter 1]
Setting up the SmartLinx Neuron 2
English
What’s in this chapter
Follow the instructions in this chapter to setup the SmartLinx Neuron. Deployment follows these
steps, in this order:
• Unpacking and inspecting the package contents
• Installing the batteries in the SmartLinx Neuron
• Deploying the SmartLinx Neuron
• Mounting the SmartLinx Neuron on the wall
• Mounting the SmartLinx Neuron on a roll stand
• Connecting the SmartLinx Neuron to the power supply
• Before you use the SmartLinx Neuron for the first time
Note: This document does not describe the configuration of the SmartLinx Neuron on a local
network. Refer to the SmartLinx MDIS System Administrator's Guide.
Unpacking and inspecting the package contents
Before you install the SmartLinx Neuron in a clinical setting, you must inspect and set it up
according to instructions.
Setting up the SmartLinx Neuron 2 [Chapter 2]
Contents of a product shipment
English
The table describes the contents of a SmartLinx Neuron shipment.
Item
SmartLinx Neuron
Shipment characteristics
In one carton, you find the SmartLinx Neuron itself, wrapped in plastic
and sandwiched between two blocks of polyethylene foam. Each
SmartLinx Neuron is shipped along with:
• Main battery
The main battery is in position inside the SmartLinx Neuron, but the
battery pins are not yet in contact with the battery socket on the
SmartLinx Neuron, and the battery is not yet fixed in place.
• Power brick
The power brick is shipped wrapped in plastic.
• Screws and washers
Included in a plastic bag, the shipment contains screws for attaching the
SmartLinx Neuron to a mounting bracket, depending on the deployment
selected:
- Four M4 Phillips-head screws of 6 mm, with associated washers
- Four M4 Phillips-head screws of 8 mm, with associated washers
Power Cable
The electrical cable that is used to connect the SmartLinx Neuron power
brick to the electrical mains outlet is shipped in a separate carton from
the SmartLinx Neuron. This cable is always adapted to local
requirements.
Extended battery
(optional)
If ordered, extended batteries are shipped in a separate carton, where
possible, the same carton as for the cables. Each extended battery is
packed in its own unit box.
This document
Printed copies of this SmartLinx Neuron 2 Hardware Installation and
Maintenance Guide are shipped separately, in the same carton as the
cables, where possible. The number of copies depends on the number of
SmartLinx Neurons in the shipment.
Additional elements Depending on the contents of your order, other connectivity elements
such as serial cables, patch cables, and DIMs, could be present in the
shipment. If yes, these are typically shipped in the same carton as for the
cables.
Unpacking the cartons
Note: If the carton is broken, open, or damaged in any way, do not accept the shipment.
1. Turn the carton so that the arrow on the package is pointing up.
2. Cut the tape on the carton.
Caution: Be careful to cut only the tape and not, for example, the SmartLinx Neuron.
10
Setting up the SmartLinx Neuron 2 [Chapter 2]
3. Take each item out of the carton.
4. Check all items against the packing list, and against the list in Contents of a product shipment
above.
5. Remove the packing material and examine each item for any signs of shipping damage.
English
6. Save all packing materials, the invoice and the bill of lading. You will require them if you need to
process a claim with the carrier.
Hardware installation prerequisites
You need the following tools (not included) to install the SmartLinx Neuron:
• one cruciform-tip screwdriver
• one flat (that is, straight) screwdriver
• one Phillips-head PH0 screwdriver
In addition, depending on how you intend to mount the SmartLinx Neuron, you could require
certain hardware:
• If you select to deploy the SmartLinx Neuron on a roll stand, you must source a roll stand pole
extension with VESA 75 or VESA 100 interface suitable for the model of your roll stand. Contact
your roll stand manufacturer for options.
• If you select to deploy the SmartLinx Neuron on a wall-mount, then you require a mounting
solution that is VESA 75/100-compatible.
Installing the batteries in the SmartLinx Neuron
Installing the main battery in the SmartLinx Neuron
The SmartLinx Neuron is shipped with the main battery in position but not yet fixed in place.
1. Push the main battery towards its connection port.
2. Use a screwdriver or other tool to screw in the two screws that hold the main battery in place.
3. Tighten the screws until the battery is connected to its pins. Do not overtighten.
Setting up the SmartLinx Neuron 2 [Chapter 2]
11
English
Installing the optional extended battery in the SmartLinx Neuron
1. Turn the SmartLinx Neuron so that the screen is facing away from you.
2. Use a screwdriver to unscrew the screw that holds the extended battery faceplate in position.
3. Push the loose faceplate to the left, then lift the faceplate away from the SmartLinx Neuron.
4. Position the extended battery at the same point where you lifted the faceplate. Because of the
arrangement of the pins, you cannot position the extended battery incorrectly.
12
Setting up the SmartLinx Neuron 2 [Chapter 2]
English
5. Slide the extended battery to the right. Continue sliding until the left side of the extended
battery is flush with the left side of the extended battery slot.
6. Push the locking button on the extended battery to the down position.
Setting up the SmartLinx Neuron 2 [Chapter 2]
13
English
Deploying the SmartLinx Neuron
In typical deployments of the SmartLinx Neuron, you can mount it on the wall, or mount it on a roll
stand or other mobile configuration using commercially available, compatible mounting solutions
(not supplied by Capsule).
It is your responsibility to select an appropriate mounting solution and ensure that it is safely setup.
Note: For compliance with EN/IEC 60601-1, the SmartLinx Neuron is not classified as a portable device.
Instead, the SmartLinx Neuron must be deployed as one of:
- Mobile device
- Fixed device
Precautions for all deployments
Warning:
Fire and explosion hazard. Do not operate the SmartLinx Neuron in the presence of a
flammable anesthetic mixture with air, oxygen, or nitrous oxide; in oxygen-enriched
environments; or in any other potentially explosive environment.
Caution:
• Do not place the SmartLinx Neuron inside furniture or inside any enclosed space. This could
prevent correct cooling of the device and interfere with radio communications.
• Operate the SmartLinx Neuron only within these environmental conditions:
- Temperature: +10°C to +40°C (+32°F to °+104°F)
- Atmospheric pressure: Atmospheric pressure: 700 hPa to 1060 hPa
- Altitude: -100 meters to +2000 meters (-328 feet to +6560 feet)
- Humidity: 10% to 95% RH non-condensing
• Do not stack the SmartLinx Neuron or place it next to other equipment. If you do, then check it
for normal operation running its usual configuration.
• In semi-private rooms, connectors must be placed or labeled so that they clearly indicate the bed
for which they collect data.
Considerations for wall-mounted deployments
When you are deciding where to place the SmartLinx Neuron at the point of care, Capsule
recommends that you take account of the following considerations.
• Mount the SmartLinx Neuron near the head of the bed or on the head wall in the patient room.
• To allow clinicians easy access to the SmartLinx Neuron touch screen, mount the SmartLinx Neuron
no more than 1.5 meters (5 feet) or less than 1 meter (3 feet, 3 inches) from the ground.
• If there are medical devices connected to the ports on the SmartLinx Neuron, position the SmartLinx
Neuron on the same side of the bed as those devices.
• Make sure that you take account of the length of the cables required to connect the SmartLinx
Neuron and the medical devices.
14
Setting up the SmartLinx Neuron 2 [Chapter 2]
Mounting the SmartLinx Neuron on the wall
Caution: For SmartLinx Neurons that are installed above the patient, take adequate precautions to
prevent them from falling on the patient.
English
Attach the SmartLinx Neuron to your selected VESA 75/100 wall-mounted solution. Refer to the
instructions from the solution manufacturer.
Mounting the SmartLinx Neuron on a roll stand
1. Mount the SmartLinx Neuron to the roll stand. Refer to the manufacturer’s instructions for the
roll stand as required.
2. Select the set of screws (delivered with your SmartLinx Neuron) whose length corresponds to
the depth of the screw holes on your VESA75/100-compatible mounting plate. Alternatively, use
the screws delivered with your roll stand pole extension to mount the SmartLinx Neuron.
Setting up the SmartLinx Neuron 2 [Chapter 2]
15
Connecting the SmartLinx Neuron to the power supply
English
Once deployed, on a wall or roll stand for example, you can connect the SmartLinx Neuron to the
power supply.
Power requirements
The SmartLinx Neuron is designed to use the IEC 60601-1-compliant, external DC power supply and
power cables that are provided with the SmartLinx Neuron. For precise information, refer to the
Technical Information in chapter 5 of this document.
Cautions:
• Always use the hospital-grade, AC power cable delivered with the product to connect the
SmartLinx Neuron to an AC power source. Do not, under any circumstances, use any other cable
than the one provided, even to provide extra cable length. The use of any other cable can result
in increased emissions or decreased immunity of the device with regards to electromagnetic
interference.
• Do not connect the SmartLinx Neuron to an AC outlet that is controlled with a switch or dimmer.
• Do not, under any circumstances, remove the grounding conductor from the power plug.
• Do not use extension cords or adapters of any type.
• The power cable, supply, and plug must remain intact and undamaged.
• The power plug must remain accessible to unplug the device from the power supply mains if
necessary.
Connecting the SmartLinx Neuron to the power supply
1. The power brick that was shipped with your SmartLinx Neuron has a power cable on one end,
and an open plug on the other end. Plug that power cable into the SmartLinx Neuron at the DC-in
power connector (as illustrated).
2. Tighten the locking mechanism on the DC-in power connector to lock the power plug in place.
3. Plug the power cable that was shipped with your SmartLinx Neuron into the open plug on the
power brick.
4. Plug the other end of that power cable into an grounded electrical outlet (generally 3-prongs).
Caution: For safety, cables are designed to prevent inadvertent disconnection if someone
accidentally pulls on them. However, make sure that you route cables so that they do not
present a tripping hazard.
Warning:
16
You must only connect the SmartLinx Neuron’s power brick to an appropriate power
source. To avoid risk of electric shock, use a grounded (3-prong) electrical power outlet.
Setting up the SmartLinx Neuron 2 [Chapter 2]
Before you use the SmartLinx Neuron for the first time
For all deployments, before you use the SmartLinx Neuron for the first time, you must completely
charge its battery.
1. Set up the SmartLinx Neuron as described in this chapter:
English
• install the main battery
• install the extended battery, if you use one
• connect the SmartLinx Neuron to the electrical mains
2. The battery/ies start to charge as soon as you plug the SmartLinx Neuron into the electrical
mains. Allow the main battery to charge for about two hours.
If you have installed both the main battery and the optional extended battery, allow the two
batteries to charge for about six hours.
For a fuller description of the batteries, and the charging / discharging process, refer to “Working
with the batteries” on page 23.
Setting up the SmartLinx Neuron 2 [Chapter 2]
17
English
Operating the SmartLinx Neuron 2
Components on the SmartLinx Neuron
Legends on the drawings
In the legend for the drawings that follow:
• Individual components keep the same numbers on each drawing. For example, the USB ports on the
bottom of the SmartLinx Neuron are shown with the number 6 . When you see the number 6 , you
know that it represents only these ports.
• Colors have meaning. A blue circle indicates a medical-grade connector. A yellow circle
indicates network connection (Ethernet). All other components are indicated with red circles.
View from the front
1 Light sensor
2 Touch screen
3 Status LED
4 RFID badging area
5 Serial ports
6 USB ports
18
Operating the SmartLinx Neuron 2 [Chapter 3]
View from the bottom
5 Serial ports (4) - front-accessible
6 USB ports (2) - front-accessible
English
7 USB ports (2) - rear-accessible
8 Serial port (1) - rear-accessible
9 Ethernet connection
10 DC power-in connector
10
3/4 view from the back
5 Serial ports (4) - front-accessible
6 USB ports (2) - front-accessible
7 USB ports (2) - rear-accessible
8 Serial port (1) - rear-accessible
9 Ethernet connection
10 DC power-in connector
10
Operating the SmartLinx Neuron 2 [Chapter 3]
19
View from the back
English
11
11 Extended battery emplacement
12
12
12 Mounting plate screwholes
(VESA 75/100 configuration)
13
13 Main battery
14
12
12
14 Covered USB port
15 Aeration vents
16 Speaker
16
15
Views from the side
17
13
14
13 Main battery
14 Covered USB port
17 Anti-theft slot
Connectivity
The ports on the SmartLinx Neuron are used to connect medical or other devices. A blue line on
these ports indicates a medical-grade connection port. A yellow line indicates the Ethernet
connection port. The tables describe the ports.
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Operating the SmartLinx Neuron 2 [Chapter 3]
Serial Ports
Location
Characteristics
Number
Purpose
Galvanic isolated RS-232
with RJ45 connector
Used to connect medical devices with serial
interfaces
Rear
Galvanic isolated RS-232
with RJ50 connector
Used to connect medical devices with serial
interfaces
English
Front
USB Ports
Location
Characteristics
Number
Purpose
Front
Galvanic isolated, Type A
USB 2.0 full-speed
Used to connect medical devices with USB
interfaces
Rear
Galvanic non-isolated,
Type A USB 2.0 high-speed
Used to connect external USB, non-medical
devices such as barcode scanners
Side (left)
Galvanic non-isolated,
Type A USB 2.0 high-speed
Additional USB, non-medical device connection
Ethernet Port
Location
Back
Characteristics
RJ45 connector
Number
Purpose
Used to connect to the hospital-internal, wired
network (Ethernet)
Powering on the SmartLinx Neuron
For information on connecting the SmartLinx Neuron to the power supply, refer to “Connecting the
SmartLinx Neuron to the power supply” on page 16.
Power on the SmartLinx Neuron
For manual operation, press the Power On/Off button, shown at position A on this illustration of
the top view of a SmartLinx Neuron:
Operating the SmartLinx Neuron 2 [Chapter 3]
21
Power On/Off button
English
Power Off the SmartLinx Neuron
To power off the SmartLinx Neuron, press the On/Off button again.
If the SmartLinx Neuron does not shut down properly for any reason, you can do a hard shutdown.
Press and hold the power button for four seconds.
Working with the SmartLinx Neuron touch screen
The SmartLinx Neuron screen is a 10.1-inch (25.6-centimeter) touch screen. It is antiglare treated,
and readable from multiple angles.
Screen brightness adjusts automatically to the level of ambient light, dimming or brightening in
parallel with the current level of luminosity in the room. If the screen goes completely dark, the
SmartLinx Neuron is said to be in ‘sleep’ mode, and you can wake it up by touching the screen.
Reading the status LED
The SmartLinx Neuron provides a single LED, located on the front of the device below the screen.
LED
22
SmartLinx Neuron Status
Off
SmartLinx Neuron is not running.
Blue - Blinking
SmartLinx Neuron is booting.
Blue
SmartLinx Neuron has finished booting, and is EMR-connected.
Red
SmartLinx Neuron has finished booting, and is not EMR-connected.
Operating the SmartLinx Neuron 2 [Chapter 3]
Working with the batteries
Warning:
English
Warning:
Defective batteries can damage the SmartLinx Neuron. If the battery shows any signs of
damage or cracking, it must be replaced immediately and only with a battery approved
by Capsule.
Improper disposal of batteries may create an explosion or contamination hazard. Never
dispose of batteries in refuse containers. Always recycle batteries according to local
regulations.
For instructions on installing the main battery, and the optional extended battery, refer to
“Installing the batteries in the SmartLinx Neuron” on page 11.
Note: Before you use each SmartLinx Neuron for the first time, you must fully charge its battery/ies,
as described in “Before you use the SmartLinx Neuron for the first time” on page 17.
Battery Lifetime Terminology
When describing the SmartLinx Neuron, the following terms are used:
• Battery autonomy refers to the amount of time that the SmartLinx Neuron can remain fully
functional in case of a disconnect from the electrical mains.
• Battery life span refers to the total time that the battery lasts before you must replace it.
Battery Summary
Characteristic
Autonomy
Main Battery
150 minutes (2 hours 30 minutes) of
functional operation when unplugged
from AC mains, with a new, fullycharged battery
Extended Battery
240 minutes (4 hours) of functional
operation when unplugged from AC
mains, with a new, fully-charged
battery
When used together, the two batteries
together provide about 360 minutes (6
hours) of autonomy.
Charging time
120 minutes (2 hours)
240 minutes (4 hours) for the extended
battery alone
360 minutes (6 hours) to charge both
batteries
Charging
First charged / Last discharged
Last charged / First discharged
Life span
After 500 complete charging cycles,
remaining capacity is about 80%.
After 500 complete charging cycles,
remaining capacity is about 80%.
Shelf-life
3 months
3 months
Swapping
By biomed user - requires no tools
other than a screwdriver
By clinical user - requires no tools
Operating the SmartLinx Neuron 2 [Chapter 3]
23
Caution: Batteries must be replaced only by qualified, certificated engineers.
English
Warning:
To avoid the possibility of an explosion, use only batteries supplied by Capsule or a
Capsule-approved reseller. If you use any other battery, you risk an explosion.
Charging the batteries
To charge the batteries, plug the cable from the SmartLinx Neuron power brick into the AC power
mains (wall socket).
To monitor the batteries during the charging process, check the battery information displayed on the
screen, and described in the Capsule document, Clinical User’s Guide for the Chart Xpress
application.
Removing a battery
Caution: Before you remove a battery from a SmartLinx Neuron which is powered on, make
sure that it continues to receive power, either from the electrical mains, or from at
least one charged battery that is installed in the SmartLinx Neuron.
Removing the main battery
Refer to the illustrations for Installing the main battery in the SmartLinx Neuron on page 11.
1. Use a screwdriver or similar tool to unscrew the two screws that hold the battery in place.
2. Pull the battery gently away from the SmartLinx Neuron to disconnect the battery from the pins.
3. Remove the battery.
Removing the extended battery
Refer to the illustrations for Installing the optional extended battery in the SmartLinx Neuron on
page 12.
1. To release the extended battery, push the locking button to the up position.
2. Slide the extended battery to the left.
3. Lift the battery out and away.
4. If desired, and if you have retained the faceplate, you can replace the faceplate on the empty
battery slot. Use a screwdriver and the screw that you removed when you installed the extended
battery.
Swapping a battery
To swap a charged battery in place of a discharged battery, or to swap a new replacement battery
for a depleted battery:
1. Remove the battery, as described above under Removing a battery.
2. Install the new battery, as described in “Installing the batteries in the SmartLinx Neuron” on
page 11.
24
Operating the SmartLinx Neuron 2 [Chapter 3]
Connecting the SmartLinx Neuron to the network
Connecting to a wired network
English
1. Plug one end of the LAN cable into the Ethernet connector, located on the rear panel of the
SmartLinx Neuron, and marked with a yellow line. In the illustrations, on page 19 for example,
this connector is labeled 9 .
2. Plug the other end of the same cable into the network socket (typically on the wall).
Connecting to a wireless network
No special procedures are required on the SmartLinx Neuron for wireless connection. However,
each SmartLinx Neuron must be configured in the SmartLinx Neuron Manager to use the wireless
network. Refer to the “SmartLinx MDIS System Administrator’s Guide” for more.
Checking the wired connection
On the Ethernet jack, there are two small LEDs. When you plug in the Ethernet connection cable,
you can check the connection through the behavior of these LEDs:
LEDs
Link/Act
10/100/1000
State
Meaning
Off
The SmartLinx Neuron is not connected to the LAN
Blinking
Network activity
On
Link is active
Off
Connected to the LAN at 10 MB speed, or
Not connected
Green
Connected at 100 MB speed
Orange
Connected at 1000 MB speed
Checking the wireless connection
You cannot check the wireless connection using SmartLinx Neuron hardware components. You
must use the network connection information displayed on the screen, and described in the
Clinical User’s Guide for the Chart Xpress application or the Vitals Stream application.
Connecting a vital signs monitor to the SmartLinx Neuron
Before you connect
Before you connect a vital signs monitor to the SmartLinx Neuron, you must program its Capsule
Device ID Module (DIM). A Capsule DIM is required for all devices connected to the SmartLinx Neuron.
For information on how to program a Capsule DIM, refer to the “SmartLinx MDIS System
Administrator’s Guide”. The Device ID Module (DIM) supports plug-and-play connectivity. Its
automatic device identification feature allows users to connect and re-connect any biomedical device
to the SmartLinx Neuron with ease. The separate DIM attached to each device through a cable
assembly allows the SmartLinx Neuron to:
Operating the SmartLinx Neuron 2 [Chapter 3]
25
• automatically identify the attached device
• initialize the appropriate Data Device Interface (DDI)
• detect when the device is disconnected and re-connected
English
Caution: If you use unapproved cables to connect medical devices to the SmartLinx Neuron, you
could cause damage to or malfunctioning of the medical device.
Connecting the cables
1. Attach the device cable from the device to the DIM (Device ID Module).
2. Attach the DIM patch cable to the RJ45-end of the DIM.
Device cable
DIM
DIM patch cable
Connecting the devices
1. Attach the RJ45-end of the cable assembly into one of the ports of the SmartLinx Neuron. Refer
to the description of “Connectivity” on page 20 for the set of available ports.
2. Connect the other end of the cable assembly to the back of the vital signs monitor.
3. Tighten the thumb screws and secure the assembly behind the monitor.
For more on using the SmartLinx Neuron with the vital signs monitor
This manual does not describe the use of the SmartLinx Neuron with vital signs monitors. Instead,
refer to the following documents:
Subject
Where to look
How to configure SmartLinx Neuron
SmartLinx MDIS System Administrator’s Guide
How to operate SmartLinx Neuron
Neuron Vitals Stream Application Clinical User’s Guide
Neuron Chart Xpress Application Clinical User’s Guide
26
Operating the SmartLinx Neuron 2 [Chapter 3]
Maintaining the SmartLinx Neuron 2
English
Capsule recommends that you carry out regular maintenance activities as described in this guide to
ensure correct operation of the device.
Warning:
Electric shock hazard. Do not open the SmartLinx Neuron or attempt repairs. The
SmartLinx Neuron has no user-serviceable internal parts. Only perform routine cleaning
and maintenance procedures specifically described in this manual. Inspection and
servicing of internal parts must only be performed by qualified service personnel.
Periodic cleaning and disinfection
Caution: When cleaning or disinfecting the SmartLinx Neuron, batteries, and cables, you must
power off the device first. However, you can use standard computer screen solution to
wipe down the SmartLinx Neuron touch screen (for example, to remove fingerprints)
during normal operation, while it is powered on.
Periodically clean and disinfect the elements in the SmartLinx Neuron, including cables and
batteries, by wiping the outer case with a lint-free cloth, lightly moistened with warm water and a
mild, non-abrasive cleaning solution containing any of the compatible cleaning agents below
(follow the manufacturer’s guidelines):
• 70% isopropyl alcohol
• 10% bleach solution
• CaviCide®
• Clorox® Disinfecting Wipes
• Clorox Healthcare™ Bleach Germicidal
Cleaner
• Sani-Cloth®, Sani-Cloth® Plus, Super SaniCloth®, Sani-Cloth® HB, Sani-Cloth® Bleach Wipe
• ANIOSURF Premium, Bacteranios SF,
SURFA’SAFE, WIP’ANIOS
Maintaining the SmartLinx Neuron 2 [Chapter 4]
27
Cleaning Precautions
English
Caution:
• Since the SmartLinx Neuron is not completely watertight:
- Do not spray cleaning liquid or foam on the SmartLinx Neuron, or submerge or soak it for
cleaning.
- Never spray or squirt any type of liquid directly on the SmartLinx Neuron; spray the liquid, gel, or
foam on a cloth and then use that cloth to rub on the device.
- Do not spill liquids on or around the unit.
- Do not expose the power cable or power brick to liquid.
- Make sure that the cover on the USB port is securely fastened.
• Do not use any other agent than those listed. (Contact Capsule for assistance if your cleaning agent
is not on the list.)
• Do not use harsh solvents.
• Do not clean, disinfect, or sterilize any part of the system by autoclaving or with the use of ethylene
oxide gas (gas sterilization).
• Do not touch, press, or rub the display panel with abrasive cleaning compounds, instruments,
brushes or rough-surface materials.
Periodic maintenance of the SmartLinx Neuron
Authorized Access
Certain components on the SmartLinx Neuron are only accessible to Capsule technical support
personnel. These elements are held in place using special screws referred to as “hexalobular
internal”.
However, other components on the SmartLinx Neuron, such as the main battery, can be removed by
biomed staff, for purposes of maintenance or cleaning, for example. These elements are held in
place using Philips screws.
Inspections
Caution: Power off the SmartLinx Neuron before you inspect the power cable and power brick.
Once per year, carry out an inspection of:
• the power cable
• the power brick
Look for any visible or other damage, overheating, or corrosion. A damaged power cable or power
brick can affect the operation of the SmartLinx Neuron. Replace damaged components with new
components.
28
Maintaining the SmartLinx Neuron 2 [Chapter 4]
Storing the SmartLinx Neuron
If the SmartLinx Neuron is not in use, make sure that you respect its storage conditions:
English
• Temperature: -20°C to +60°C (-4°F to +140°F)
• Humidity: 0% to 95% RH non-condensing
• Atmospheric pressure: 500 hPa to 1060 hPa
Maintenance of the SmartLinx Neuron batteries
Cleaning
When cleaning the SmartLinx Neuron batteries, apply the cleaning procedures and precautions
described above under “Periodic cleaning and disinfection”.
Short-term maintenance
For daily usage purposes, it is recommended that you keep the batteries in charge mode; that is,
keep the batteries installed in the SmartLinx Neuron, and keep the SmartLinx Neuron connected to
the electrical mains.
Long-term storage and maintenance
Shelf life of the batteries
Both the main and the extended batteries for SmartLinx Neuron have a shelf life of three months.
This limit applies to batteries that are not in use (that is, if they are not either in the process of
charging, or being used to supply power to the SmartLinx Neuron).
If the battery fully discharges, during storage for example, then you must replace it.
Caution: Both the main battery and the extended battery have shelf lives of three months from the
date of manufacture. You must install a newly received battery in a SmartLinx Neuron, and
fully charge the battery within three months of receipt. Refer to the SmartLinx Neuron
packaging for the battery expiration date.
Storing the batteries
If the SmartLinx Neuron is not in use for an extended period of time, we recommend that you:
1. Charge the battery completely.
2. Remove the fully charged battery from the SmartLinx Neuron (refer to “Removing a battery” on
page 24).
3. To maximize the battery life span, make sure that you store the battery within the
recommended parameters:
• Temperature: -20°C to +60°C (-4°F to +140°F)
• Humidity: 0% to 95% RH non-condensing
• Atmospheric pressure: 500 hPa to 1060 hPa
• Store the battery and the SmartLinx Neuron separately.
Maintaining the SmartLinx Neuron 2 [Chapter 4]
29
English
30
Maintaining the SmartLinx Neuron 2 [Chapter 4]
Technical Information
English
Guidance and manufacturer’s declaration
Electromagnetic Effects
The SmartLinx Neuron radiates and consumes radio frequency energy. It has been designed and
evaluated to comply with the emission and immunity requirements of EN/IEC 60601-1-2, but
electromagnetic interference may occur if not installed correctly and used in accordance with the
instructions in this manual. Refer to the Tables in this chapter for detailed information regarding
declaration and guidance related to emission, immunity, and separation distances.
Caution:
• Portable and mobile radio frequency devices, such as mobile phones, can impact the correct
functioning of this device and should not be used in close proximity of this device.
• Use of accessories, power adapters and cables other than those specified may result in
increased emission and/or decreased immunity of the SmartLinx Neuron.
Electromagnetic Emissions
The SmartLinx Neuron is intended for use in the electromagnetic environment specified below. The
customer or the user of the SmartLinx Neuron should make sure that it is used in such an
environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions CISPR 11
Group 1
The SmartLinx Neuron uses RF energy only for its
internal function; its RF emissions are therefore very
low and are not likely to cause any interference to
nearby electronic equipment
RF emissions CISPR 11
Class A
Harmonic emissions IEC
61000-3-2
Class A
Voltage fluctuations/
flicker emissions IEC
61000-3-3
Complies
Class A: The SmartLinx Neuron is suitable for use in
all establishments other than domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
Note: UT is the AC mains voltage prior to application of the test level.
Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)
The SmartLinx Neuron is intended for use in the electromagnetic environment specified below. The
Technical Information [Chapter 5]
31
customer or the user of the SmartLinx Neuron should ensure that it is used in such an environment.
English
Immunity Test
IEC 60601 test level
Electromagnetic environment Guidance
Electrostatic
discharge (ESD) IEC
61000-4-2
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±2 kV for
power supply
lines
Mains power quality should be that of a
typical commercial or hospital
environment.
±1 kV for input/
output Lines
±1 kV for
input/output
Lines
Surge IEC 61000-4-5 ±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines IEC
61000-4-11
±1 kV line(s) to Mains power quality should be that of a
line(s)
typical commercial or hospital
environment.
±2 kV line(s) to
earth
<5% UT (>95% dip
in UT) for 0.5 cycle
>95% voltage
dips in UT for
0.5 cycles
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the
SmartLinx Neuron requires continued
40% UT (60% dip in 60% voltage
operation during power mains
dips in UT for 5 interruptions, it is recommended that
UT) for 5 cycles
cycles
the SmartLinx Neuron be powered from
an uninterruptible power supply.
70% UT (30% dip in 30% voltage
dips in UT for
UT) for 25 cycles
25 cycles
<5% UT (>95% dip
in UT) for 5 sec
>95% voltage
interruption in
UT for 5
seconds
Power frequency
3 A/m
(50/60 Hz) magnetic
field IEC 61000-4-8
32
Compliance
level
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical hospital
environment.
Technical Information [Chapter 5]
Electromagnetic Immunity (RF Conducted and Radiated)
The SmartLinx Neuron is intended for use in the electromagnetic environment specified in the
table. The customer or the user of the SmartLinx Neuron should make sure that it is used in such an
environment.
IEC 60601
test level
Compliance
level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to
80 MHz
3V
Radiated RF 3 V/m 80
IEC 61000-4-3 MHz to 2.5
GHz
3 V/m
English
Immunity
Test
Electromagnetic environment - Guidance
Portable and mobile RF communications
equipment should be used no closer to any part of
the SmartLinx Neuron, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter. Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya,
should be less than the compliance level in each
frequency rangeb. Interference may occur in the
vicinity of equipment marked with this symbol:
Note: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: 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 radio, 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 SmartLinx Neuron is used exceeds the applicable RF compliance level above, the
SmartLinx Neuron should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the SmartLinx
Neuron 2.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Technical Information [Chapter 5]
33
Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and the SmartLinx Neuron
English
The SmartLinx Neuron is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the SmartLinx Neuron can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the SmartLinx Neuron as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter (W)
Separation distance in meters
according to frequency of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1.17
1.17
2.33
10
3.70
3.70
7.37
100
11.70
11.70
23.30
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
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.
34
Technical Information [Chapter 5]
SmartLinx Neuron technical specifications
SmartLinx Neuron Part Number: DC-NU2-UMPC
Width: 265 mm (10.4 inches)
Height: 210 mm (8.3 inches)
Depth: 45 mm (1.8 inches)
Weight
2.0 kg (2.3 kg with batteries)
Mounting options
VESA 75/100 standard mounting bracket
Electrical ratings
20 V DC, 3.25 A max
External power supply
100-240 V AC, 2.0-1.0 A, 50-60 Hz, 65 W max
Battery
Main: Lithium-lon Battery Pack 3S1P 2600 mAh
Extended: Lithium-lon Battery Pack 3S2P 5200 mAh
English
Dimensions
Protection against electric shock Class II
Protection against ingress of
water
IPX0
Non-protected according to EN/IEC 60529
Suitability for use in oxygen-rich No suitable
environments
Mode of operation
Continuous
Display size
10.1 inch (25.6 centimeter), resistive touch screen, resolution
1024x600
Display brightness
375 cd/m²
Contrast
400:1
Memory
2 GB
Storage
16 GB SSD
Network connectivity
10/100/1000 base-T LAN
WLAN IEEE 802.11 a/b/g/n
WLAN security
WPA & WPA2 personal, WPA & WPA2 enterprise
Encryption: TKIP, AES
WLAN operating frequency
For 2.4 GHz band: 2412 MHz ~ 2472 MHz
For 5.0 GHz band: 5180 MHz ~ 5320 MHz
5500 MHz ~ 5700 MHz
WLAN modulation
Modulation technology: DSSS, OFDM
Modulation type: CCK, DQPSK, DBPSK for DSSS, 64QAM,
16QAM, QPSK, BPSK for OFDM
Technical Information [Chapter 5]
35
English
SmartLinx Neuron Part Number: DC-NU2-UMPC
WLAN EIRP (Equivalent
Isotropically Radiated Power)
For 2.4 GHZ: 18.59dBM
For 5.18 ~ 5.32 GHz: 18.69dBm
For 5.50 ~ 5.70 GHz: 18.41dBm
Wireless range
10-20 meters, depending on Wi-Fi network configuration
RFID operating frequency
13.56MHz
RFID modulation
ASK
RFID EIRP
-31.92dBm
Cooling
Passive cooling system (fanless)
Operating environment
• Temperature: 0°C to +40°C (+32°F to +104°F)
• Humidity: 10% to 95% RH non-condensing
• Atmospheric pressure: 700 hPa to 1060 hPa
• Altitude: -100 m to 2000 m (-330 feet to 6560 feet)
Transport and storage
environment
• Temperature: -20°C to +60°C (-4°F to +140°F)
• Humidity: 0% to 95% RH non-condensing
• Atmospheric pressure: 500 hPa to 1060 hPa
Device Identification Module (DIM) technical specifications
DIMs do not require an external power supply and use standard DB9 and RJ45 connections. The
Device ID Module is a medical grade product compliant with IEC 60601-1 requirements.
Device ID Module P/N B1-DIM-CT-01
Features
• Provides Automatic Device Identification
• DB9 Serial Port Input
• RJ45 Serial Port Output
• Powered from the SmartLinx Neuron, Terminal Server, or
DTS and RTS lines
Dimensions
• Length: 69 mm (2.7 inches)
• Width: 38 mm (1.5 inches)
• Height: 22 mm (0.9 inches)
• Weight: 50 grams (1.76 ounces)
Power requirements
• +/- 6V output voltage
• 3 to 8 milliamp power consumption
36
Technical Information [Chapter 5]
Device ID Module P/N B1-DIM-CT-01
Temperature
• Operating: 0° C - 55° C (32° F to 130° F)
• Storage: -30° C to +85° C (-22° F to +185° F)
• Operating: 0 to 99% non-condensing
English
Relative humidity
• Storage: 0 to 99% non-condensing
Atmospheric pressure
• Operating: 700 hPa to 1060 hPa
• Storage: 500 hPa to 1060 hPa
Certifications
• EN60601-1, EN60601-1-2
• CE Marking, RoHS-compliant
Regulatory Information
Explanation of Device and Packaging Symbols
Symbol
Description
Read the operating instructions before using the medical device.
Lot number
Quantity
Product part number
Product serial number
Product revision
Gross weight
Net weight
Temperature limitation for transport and storage
Technical Information [Chapter 5]
37
Symbol
Description
English
Air pressure limitation for transport and storage
Shelf-life of SmartLinx Neuron’s battery (with date three months
after manufacture)
2017-06
Manufactured date
Manufactured for
Do not use if package is damaged
Fire hazard
Relative humidity (non-condensing) for transport and storage
Ethernet MAC address
Ethernet
Wi-Fi
Wi-Fi MAC address
Caution: consult accompanying documents before using
Power symbol
Non-ionizing radiation
Compliance with FCC Regulations
38
Technical Information [Chapter 5]
Symbol
Description
Compliance with European directives
Rx Only
English
Class 2 radio equipment
Caution: United States Federal Law restricts this device to sale by or on
the order of a physician or licensed practitioner
Separate collection for electrical and electronic waste (WEEE
directive and Battery directive)
Class II equipment
Direct current (DC)
USB connection
Serial connection
Input power
Recycling
Recognized component
Conforms to ANSI/AAMI ES 60601-1 Standard
Certified to CAN/CSA Standard C22.2 No. 60601-1
Australian compliance mark
Safety and Regulatory Compliance
EN/IEC
SmartLinx Neuron complies with EN/IEC 60601-1 and EN/IEC 60601-1-2.
• Data Integrity: SmartLinx Neuron does not compromise the data coming from the medical device.
This does not include data not being delivered or delays in data delivery.
• Medical Device Integrity: SmartLinx Neuron does not compromise the operation of the connected
medical devices.
Technical Information [Chapter 5]
39
Federal Communications Commission
SmartLinx Neuron complies with Part 15 of the FCC Rules. Operation is subject to two conditions:
English
• This device may not cause harmful interference.
• This device must accept any interference received, including interference that may cause undesired
operation.
Note: This equipment has been tested and found to comply with the limits for a Class A digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference when the equipment is operated in a commercial environment. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed and used
in accordance with the instruction manual, may cause harmful interference to radio
communications. Operation of this equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct the interference at his own
expense.
Note: For operation within 5.15 ~ 5.25GHz / 5.47 ~5.725GHz frequency range, SmartLinx Neuron 2 is
restricted to indoor environment. The band from 5600-5650 MHz will be disabled by the
software during the manufacturing and cannot be changed by the end user. This device meets all
the other requirements specified in Part 15E, Section 15.407 of the FCC Rules.
Caution: Capsule is not responsible for any radio or television interference caused by unauthorized
changes or modifications to this equipment. Unauthorized changes or modifications could
void the user’s authority to operate the equipment.
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 transmitter must not be co-located or operating in conjunction with any other
antenna or transmitter.
Radiation Exposure Statement
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment. This equipment should be installed and operated with minimum distance 20 cm
between the radiator and your body.
Note: The country code selection is for non-US model only and is not available on all US models. Per
FCC regulation, all Wi-Fi products marketed in the USA must fixed to US-operation channels only.
CE Declaration
The SmartLinx Neurons are class I devices that comply with the requirement of the Council Directive
93/42/EEC of June 14, 1993 concerning medical devices and carry CE-marking accordingly.
The SmartLinx Neuron complies with essential requirements and other relevant provisions of the
Council Directive 1999/5/EC of March 9, 1999 concerning radio equipment and telecommunications
terminal equipment and carry CE-marking accordingly.
This equipment may be operated in:
40
Technical Information [Chapter 5]
Country
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Iceland
Liechtenstein
Norway
Switzerland
Bulgaria
Romania
Turkey
English
Austria
Belgium
Cyprus
Czech Republic
Croatia
Denmark
Estonia
Finland
France
Germany
Greece
Certain countries have specific restrictions for, or prohibitions on devices that operate in the 5 GHz
band. Specifically in certain European countries, for example, some frequencies should be
restricted to indoor use. You are advised to respect local requirements.
For a copy of the full R&TTE Declaration of Conformity, contact your Capsule Technologie
representative. (For contact details, refer to “Distribution and Service” on page 8 of this manual.)
The Device ID Module (DIM) complies with the requirement of the Council Directives 2006/95/EC of
December 12, 2006 concerning electrical equipment designed for use within certain voltage limits
and 2004/108/EC of December 15, 2004 concerning electromagnetic compatibility.
Batteries in the SmartLinx Neuron are not based on mercury, lead or cadmium technologies. The
batteries used in this product are in compliance with the Council Directive 2006/66/EC.
Chromium, lead, mercury, or cadmium are not intentionally added to packaging materials and are
not present in a cumulative concentration greater than 100 ppm as incidental impurities. No
halogenated plastics or polymers are used for packaging material. Packaging is compliant with the
Council Directive 94/62/EC.
Industry Canada statement
This device complies with RSS-210 of the Industry Canada 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.
Caution:
(i) the device for operation in the band 5150-5250 MHz is only for indoor use to reduce the
potential for harmful interference to co-channel mobile satellite systems;
(ii) the maximum antenna gain permitted for devices in the bands 5250-5350 MHz and 54705725 MHz shall comply with the e.i.r.p. limit; and
(iii) the maximum antenna gain permitted for devices in the band 5725-5825 MHz shall comply
with the e.i.r.p. limits specified for point-to-point and non point-to-point operation as
appropriate.
(iv)Users should also be advised that high-power radars are allocated as primary users (i.e.
priority users) of the bands 5250-5350 MHz and 5650-5850 MHz and that these radars could
cause interference and/or damage to LE-LAN devices.
Technical Information [Chapter 5]
41
FOR MOBILE DEVICE USAGE (>20cm/low power)
Radiation Exposure Statement:
English
This equipment complies with IC radiation exposure limits set forth for an uncontrolled
environment. This equipment should be installed and operated with minimum distance 20cm
between the radiator & your body.
RoHS and WEEE Compliance
The SmartLinx Neuron, and DIM do NOT contain any of the following substances (in concentrations
exceeding legal threshold limits):
• Lead
• Mercury
• Cadmium
• Hexavalent Chromium
• Polybrominated Biphenyls (PBB)
• Polybrominated Diphenyl Ethers (PBDE)
In the European Union, SmartLinx Neuron, DIM, batteries, and cables should be collected separately
and not disposed of with household waste. Refer to the next section on Recycling and the
Environment for more details.
Recycling and the Environment
Improper disposal of IT equipment can have a negative impact on health and the environment. The
SmartLinx Neuron, DIM, batteries, and serial cables should be deposited at an appropriate facility to
enable recovery and recycling. Packaging and manuals can also be recycled according to your local
recycling scheme.
42
Technical Information [Chapter 5]

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