Capsule Technologie 002 SmartLinx Neuron 2 User Manual IandM Neuron 2

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August 22, 2014

SmartLinx Neuron 2

Hardware

Installation and

Maintenance Guide

English

Legal Notice

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.

Table of Contents

English

Contents

Chapter 1: Introducing the SmartLinx Neuron 2 5

Overview 5

Intended Use 5

About this document 6

Product designation in this document 6

Purpose 6

Audience 6

Notes, cautions, warnings 6

Related documents

Capsule provides the following additional documents for use with the SmartLinx Neuron.

Manufacturer’s Information

Document Description Audience

SmartLinx MDIS System

Administrator's Guide

(English only)

provides information on deployment scenarios and instructions

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

Hospital IT staff

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:

•Help menu of the SmartLinx Neuron Manager

•Capsule Customer Portal

•Help icon in the application

Clinicians

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:

•Help menu of the SmartLinx Neuron Manager

•Capsule Customer Portal

•Help icon in the application

Clinicians

Capsule Technologie SAS

9 Villa Pierre Ginier

75018, Paris France

Phone: (+33) 1 5334 1400

English

Introducing the SmartLinx Neuron 2 [Chapter 1]

Distribution and Service

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:

Table of abbreviations

The table provides an alphabetical list of the main abbreviations used in this document.

USA EMEA & APAC

Capsule Tech, Inc.

300 Brickstone Square, Suite 203

Andover, MA 01810 USA

Phone: 1-978-482-2300

Toll Free: 1-800-260-9537

Capsule Technologie

9 Villa Pierre Ginier

75018, Paris France

Phone: (+33) 1 5334 1400

Technical Support in North America

Phone: 1-800-260-9537

E-mail: support@capsuletech.com

Technical Support outside North America

Phone: (+33) 1 8417 1200

E-mail: emea.support@capsuletech.com

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

Setting up the SmartLinx Neuron 2 [Chapter 2] 9

English

Setting up the SmartLinx Neuron 2

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.

10 Setting up the SmartLinx Neuron 2 [Chapter 2]

English

Contents of a product shipment

The table describes the contents of a SmartLinx Neuron shipment.

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.

Item Shipment characteristics

SmartLinx Neuron 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.

Caution: Be careful to cut only the tape and not, for example, the SmartLinx Neuron.

Setting up the SmartLinx Neuron 2 [Chapter 2] 11

English

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.

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.

12 Setting up the SmartLinx Neuron 2 [Chapter 2]

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.

Setting up the SmartLinx Neuron 2 [Chapter 2] 13

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.

14 Setting up the SmartLinx Neuron 2 [Chapter 2]

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

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.

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.

Setting up the SmartLinx Neuron 2 [Chapter 2] 15

English

Mounting the SmartLinx Neuron on the wall

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.

Caution: For SmartLinx Neurons that are installed above the patient, take adequate precautions to

prevent them from falling on the patient.

16 Setting up the SmartLinx Neuron 2 [Chapter 2]

English

Connecting the SmartLinx Neuron to the power supply

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.

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).

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.

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: 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] 17

English

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:

• 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.

Operating the SmartLinx Neuron 2 [Chapter 3]

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 . When you see the number , 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

Light sensor

Touch screen

Status LED

RFID badging area

Serial ports

USB ports

5 6

Operating the SmartLinx Neuron 2 [Chapter 3] 19

English

View from the bottom

3/4 view from the back

5 6

8 10

Serial ports (4) - front-accessible

USB ports (2) - front-accessible

USB ports (2) - rear-accessible

Serial port (1) - rear-accessible

Ethernet connection

DC power-in connector

Serial ports (4) - front-accessible

USB ports (2) - front-accessible

USB ports (2) - rear-accessible

Serial port (1) - rear-accessible

Ethernet connection

DC power-in connector

Operating the SmartLinx Neuron 2 [Chapter 3]

English

View from the back

Views from the side

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.

12 12

Extended battery emplacement

Mounting plate screwholes

(VESA 75/100 configuration)

Main battery

Covered USB port

Aeration vents

Speaker

17 13 14

Main battery

Covered USB port

Anti-theft slot

Operating the SmartLinx Neuron 2 [Chapter 3] 21

English

Serial Ports

USB Ports

Ethernet Port

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 on this illustration of

the top view of a SmartLinx Neuron:

Location Characteristics Number Purpose

Front Galvanic isolated RS-232

with RJ45 connector

4Used to connect medical devices with serial

interfaces

Rear Galvanic isolated RS-232

with RJ50 connector

1Used to connect medical devices with serial

interfaces

Location Characteristics Number Purpose

Front Galvanic isolated, Type A

USB 2.0 full-speed

2Used to connect medical devices with USB

interfaces

Rear Galvanic non-isolated,

Type A USB 2.0 high-speed

2Used to connect external USB, non-medical

devices such as barcode scanners

Side (left) Galvanic non-isolated,

Type A USB 2.0 high-speed

1Additional USB, non-medical device connection

Location Characteristics Number Purpose

Back RJ45 connector 1Used to connect to the hospital-internal, wired

network (Ethernet)

Operating the SmartLinx Neuron 2 [Chapter 3]

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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 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.

APower On/Off button

Operating the SmartLinx Neuron 2 [Chapter 3] 23

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Working with the batteries

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

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.

Warning: 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.

Characteristic Main Battery Extended Battery

Autonomy 150 minutes (2 hours 30 minutes) of

functional operation when unplugged

from AC mains, with a new, fully-

charged 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]

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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

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.

Caution: Batteries must be replaced only by qualified, certificated engineers.

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.

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.

Operating the SmartLinx Neuron 2 [Chapter 3] 25

English

Connecting the SmartLinx Neuron to the network

Connecting to a wired network

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 .

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:

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:

LEDs State Meaning

Link/Act Off The SmartLinx Neuron is not connected to the LAN

Blinking Network activity

On Link is active

10/100/1000 Off Connected to the LAN at 10 MB speed, or

Not connected

Green Connected at 100 MB speed

Orange Connected at 1000 MB speed

Operating the SmartLinx Neuron 2 [Chapter 3]

English

• automatically identify the attached device

• initialize the appropriate Data Device Interface (DDI)

• detect when the device is disconnected and re-connected

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.

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:

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.

Device cable DIM DIM patch cable

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

Maintaining the SmartLinx Neuron 2 [Chapter 4] 27

English

Maintaining the SmartLinx Neuron 2

Capsule recommends that you carry out regular maintenance activities as described in this guide to

ensure correct operation of the device.

Periodic cleaning and disinfection

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):

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.

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.

• 70% isopropyl alcohol • 10% bleach solution

• CaviCide® • Clorox® Disinfecting Wipes

• Clorox Healthcare™ Bleach Germicidal

Cleaner

• Sani-Cloth®, Sani-Cloth® Plus, Super Sani-

Cloth®, Sani-Cloth® HB, Sani-Cloth® Bleach Wipe

• ANIOSURF Premium, Bacteranios SF,

SURFA’SAFE, WIP’ANIOS

Maintaining the SmartLinx Neuron 2 [Chapter 4]

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Cleaning Precautions

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

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.

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.

Caution: Power off the SmartLinx Neuron before you inspect the power cable and power brick.

Maintaining the SmartLinx Neuron 2 [Chapter 4] 29

English

Storing the SmartLinx Neuron

If the SmartLinx Neuron is not in use, make sure that you respect its storage conditions:

• 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.

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.

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.

Maintaining the SmartLinx Neuron 2 [Chapter 4]

English

Technical Information [Chapter 5] 31

English

Technical Information

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.

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.

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

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.

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 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.

Harmonic emissions IEC

61000-3-2

Class A

Voltage fluctuations/

flicker emissions IEC

61000-3-3

Complies

Technical Information [Chapter 5]

English

customer or the user of the SmartLinx Neuron should ensure that it is used in such an environment.

Immunity Test IEC 60601 test level Compliance

level

Electromagnetic environment -

Guidance

Electrostatic

discharge (ESD) IEC

61000-4-2

±6 kV contact ±6 kV contact Floors should be wood, concrete or

ceramic tile. If floors are covered with

synthetic material, the relative

humidity should be at least 30%.

±8 kV air ±8 kV air

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)

±1 kV line(s) to

line(s)

Mains power quality should be that of a

typical commercial or hospital

environment.

±2 kV line(s) to

earth

±2 kV line(s) to

earth

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines IEC

61000-4-11

<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

operation during power mains

interruptions, it is recommended that

the SmartLinx Neuron be powered from

an uninterruptible power supply.

40% UT (60% dip in

UT) for 5 cycles

60% voltage

dips in UT for 5

cycles

70% UT (30% dip in

UT) for 25 cycles

30% voltage

dips in UT for

25 cycles

<5% UT (>95% dip

in UT) for 5 sec

>95% voltage

interruption in

UT for 5

seconds

Power frequency

(50/60 Hz) magnetic

field IEC 61000-4-8

3 A/m 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] 33

English

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.

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 pre-

dicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF trans-

mitters, 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.

Immunity

Test

IEC 60601

test level

Compliance

level Electromagnetic environment - Guidance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to

80 MHz

3 V 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:

Radiated RF

IEC 61000-4-3

3 V/m 80

MHz to 2.5

GHz

3 V/m

Technical Information [Chapter 5]

English

Recommended Separation Distances Between Portable and Mobile RF

Communications Equipment and the SmartLinx Neuron

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.

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.

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

11.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30

Technical Information [Chapter 5] 35

English

SmartLinx Neuron technical specifications

SmartLinx Neuron Part Number: DC-NU2-UMPC

Dimensions 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

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

environments

No suitable

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]

English

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.

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 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

SmartLinx Neuron Part Number: DC-NU2-UMPC

Technical Information [Chapter 5] 37

English

Regulatory Information

Explanation of Device and Packaging Symbols

Temperature • Operating: 0° C - 55° C (32° F to 130° F)

• Storage: -30° C to +85° C (-22° F to +185° F)

Relative humidity • Operating: 0 to 99% non-condensing

• 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

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

Device ID Module P/N B1-DIM-CT-01

Technical Information [Chapter 5]

English

Air pressure limitation for transport and storage

Shelf-life of SmartLinx Neuron’s battery (with date three months

after manufacture)

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

Symbol Description

2017-06

Technical Information [Chapter 5] 39

English

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.

Compliance with European directives

Class 2 radio equipment

Rx Only 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

Symbol Description

Technical Information [Chapter 5]

English

Federal Communications Commission

SmartLinx Neuron complies with Part 15 of the FCC Rules. Operation is subject to two conditions:

• 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.

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:

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.

Technical Information [Chapter 5] 41

English

Country

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.

Austria

Belgium

Cyprus

Czech Republic

Croatia

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Slovakia

Slovenia

Spain

Sweden

United Kingdom

Iceland

Liechtenstein

Norway

Switzerland

Bulgaria

Romania

Turkey

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 5470-

5725 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]

English

FOR MOBILE DEVICE USAGE (>20cm/low power)

Radiation Exposure Statement:

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.

Capsule Technologie 002 SmartLinx Neuron 2 User Manual IandM Neuron 2

Capsule Technologie S.A.S. SmartLinx Neuron 2 IandM Neuron 2

User Manual.pdf

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