Delsys TRIGNO Manuale utente

TRIGNOTM Wireless System

User’s Guide

Feb. 2009 Edition

Specifications and procedures outlined in

this document are subject to change

without notice.

Delsys Logo, EMGworks, and Myomonitor

are Registered Trademarks of Delsys

Incorporated.

MAN-012-1-0

Table of Contents

Table of Contents .............................................................. 1

Important Information ....................................................... 3

Intended Use .......................................................................... 3

Contraindications.................................................................... 3

Technical Service and Support............................................... 3

Warnings and Precautions...................................................... 4

Device Information.................................................................. 5

Disclaimer............................................................................... 7

Limited Warranty..................................................................... 7

TrignoTM Wireless EMG System...................................... 8

TrignoTM System Components........................................ 9

Wireless EMG Sensor ............................................................ 9

Sensor LED Indicator Status ...................................................... 9

Base Station ......................................................................... 10

Power Supply........................................................................ 10

Sensor Adhesive Skin Interfaces.......................................... 11

Getting Started with the TrignoTM System................... 12

Powering the Base Station ................................................... 12

Charging the Sensors........................................................... 12

Turing the Sensor ON........................................................... 12

Using EMGworks with the TrignoTM System....................... 13

Using the Wireless EMG Sensors ........................................ 14

Orienting the EMG Sensors on the Skin................................... 14

Using the Delsys Adhesive Sensor Interface ........................... 15

Maintenance and Care..................................................... 16

Trigno Sensors ..................................................................... 16

Recharging Base Station...................................................... 16

Specifications .................................................................. 18

Trigno Sensors ..................................................................... 18

Trigno Recharging Base Station........................................... 19

2 Trigno Wireless System User’s Guide

Important Information

Intended Use

The TrignoTM Wireless EMG Systems are designed for research,

investigational and scholarship purposes only. Delsys®products

are not intended for measurement purposes or for use in the

treatment and diagnosis of humans.

Rx ONLY

Contraindications

Technical Service and Support

For information and assistance visit our web site at:

www.delsys.com

E-mail: [email protected]m

tel: (617) 236 0599

DO NOT USE on Patients with implanted electronic devices of

any kind, including cardiac pace-makers or similar assistive

devices, electronic infusion pumps, and implanted stimulators.

DO NOT USE on irritated skin or open wounds.

DO NOT USE on Patients with allergies to Silver.

4 Trigno Wireless EMG System User’s Guide

Warnings and Precautions

Consult all accompanying documents for precautionary statements and

other important information.

Consult accompanying user’s guide for detailed instructions.

Keep the device dry. The presence of liquids may compromise the

safety features of the device.

Handle with care.

Sensitive electronic device. Avoid static discharges. Do not operate or

store near strong electrostatic, electromagnetic, magnetic or radioactive

fields. Interference from external sources may decrease the signal-to-

noise ratio or result in corrupted data.

Connect only to Delsys-approved devices.

Connecting a patient to high-frequency surgical equipment while using

Delsys EMG systems may result in burns at the site of the EMG sensor

contacts.

Immediately discontinue device use if skin irritation or discomfort

occurs.

Immediately discontinue device use if a change in the device’s perfor-

mance is noted. Contact Delsys technical support for assistance.

Delsys Inc. guarantees the safety, reliability, and performance of the

equipment only if assembly, modifications and repairs are carried out by

authorized technicians; the electrical installation complies with the

appropriate requirements; and the equipment is used in accordance with

the instructions for use.

Device contains a Lithium-Polymer battery. Do not damage, crush,

burn, freeze or otherwise mishandle the device. Recharge only with the

approved power supply and recharger.

Trigno Systems should be stored and operated between 5 and 50 degrees

Celsius due to the presence of an internal Lithium Polymer rechargeable

cell. Storing or operating the device, and consequently the cell, outside

of this temperature range may compromise the integrity and the safety

features of the cell.

Device Information

Complies with Requirements put forth by the Medical Device Directive

93/42/EEC. Class I device, Annex VII.

Type BF device (IEC 60601-1).

Isolated device, (Class II, IEC 60601-1)

Do not dispose this product with house waste. Contact Delsys Inc. for

instructions on responsibly disposing this device. This product should

not be mixed with other commercial wastes.

Date of Manufacturing (appears on device)

Serial Number (appears on device)

FCC ID: W4P-SP-W02 (Trigno Base Station)

FCC ID: W4P-SP-W01 (Trigno Sensor)

IC: 8138A-DST01 (Trigno System)

This device complies with Part 15 of the FCC Rules. Operation is sub-

ject 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.

This product complies with FCC OET Bulletin 65 radiation exposure

limits set forth for an uncontrolled environment.

Changes not expressly approved by Delsys Inc.could void the User’s

authority to operate the equipment

REPEC

EMERGO EUROPE

Molenstraat 15

2513 BH, The Hague

The Netherlands

DELSYS INC.

650 Beacon St.

Boston MA 02215

USA

Authorized Representative Manufacturer

6 Trigno Wireless EMG System User’s Guide

To reduce potential radio interference to other users, the antenna type

and its gain should be so chosen that the equivalent isotropically radi-

ated power (EIRP) is not more than that required for successful commu-

nication.

This equipment has been tested and found to comply with the limits for

a Class B digital device, pursuant to Part 15 of the FCC Rules. These

limits are designed to provide reasonable protection against harmful

interference in a residential installation. This equipment generates, uses,

and can radiate radio frequency energy and, if not installed and used in

accordance with the instructions, may cause harmful interference to

radio communications. There is no guarantee that interference will not

occur in a particular installation. If this equipment does cause harmful

interference to radio or television reception, which canbe determined by

turning the equipment off and on, the user is encouraged to try to correct

the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and receiver.

• Connect the equipment into outlet on a separate circuit.

Disclaimer DELSYS INC. makes no warranties, express or implied, as to

the quality and performance of this product including but not

limited to, any implied warranty of applicability for other than

research uses by qualified individuals. DELSYS INC. shall not

be liable to any person for any medical expenses or any direct or

consequential damages resulting from any defect, failure or mal-

function, whether a claim for such damages is based upon theory

of warranty, contract, tort or otherwise. No representative, agent,

or licensed practitioner is authorized to waive this disclaimer.

DELSYS INC. makes no diagnosis or prescription by virtue of

anything about this product.

Limited Warranty

The TrignoTM Wireless EMG Systems are warranted against fail-

ure of materials and workmanship for a period of 1 year from the

date of delivery, provided that the product is given proper care

and has not been subject to abuse during this period. This war-

ranty is in lieu of all other warranties expressed or implied.

Operation of this device outside specifications determined by

DELSYS INC. or use with any other input devices other than

DELSYS INC. sensors constitute an invalidation of this limited

warranty. This warranty is not transferable.

8 Trigno Wireless EMG System User’s Guide

TrignoTM Wireless EMG System

The TrignoTM Wireless EMG System is a high-performing

device unparalleled in its sophistication, its reliability and its

ease-of-use. Each EMG sensor has a built-in triaxial

accelerometer, a guaranteed transmission range of 20m and a

rechargeable battery lasting 7 hours. The system is capable of

streaming data to EMGworks Acquisition and Analysis software

and of generating 16 EMG and 48 accelerometer analog

channels for integration with motion capture and other 3rd party

data acquisition systems. Full triggering features further expand

the possibility for integration with additional measurement

technologies.

Figure 1. Complete Trigno Wireless System

1Wireless Sensor 5Analog Output Connectors

2Base Station 6Trigger Port

3USB Port 7Antenna

4Power Jack/Power Supply 8EMGworks Software

(not shown)

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