Delsys TRIGNO Manuale utente

TRIGNOTM EMG System

Delsys Logo and EMGworks are

Registered Trademarks of Delsys Inc.

MAN-015-1-3

Spring Contact Adapter User’s Guide

Trigno Spring Contact Adapter User’s Guide

Table of Contents

Important Information 4

Intended Use 4

Technical Service and Support 4

Warnings and Precauons 5

Device Informaon 6

Disclaimer 8

System Requirements 8

Spring Contact Adpater Overview 9

Using the Sensors 10

Charging the Sensors 10

Sensor Pairing 11

Smart Sensor Features 12

Applying the Spring Contact Adapters 13

Maintenance and Care 15

Specications 17

Trigno Spring Contact Adapter User’s Guide4

Important Information

Intended Use

e TrignoTM Wireless EMG Systems are battery-powered bio-

feedback devices that enable researchers and clinicians to acquire

EMG and related signals from subjects for biofeedback purposes.

ey are intended for relaxation training and muscle reeducation.

Interpretation of the EMG and supporting signals by a qualied

individual is required.

Rx ONLY

DO NOT USE on Patients with implanted electronic devices of

any kind, including cardiac pace-makers or similar assistive de-

vices, electronic infusion pumps, and implanted stimulators.

DO NOT USE on irritated skin or open wounds.

DO NOT USE on Patients with allergies to Silver.

DO NOT USE in critical care applications.

Technical Service and Support

For information and assistance visit our web site at:

www.delsys.com

telephone: (508) 545 8200

email: [email protected]

5TrignoTM EMG System

Warnings and Precautions

Consult all accompanying documents for precautionary state-

ments and other important information.

Consult accompanying user’s guide for detailed instructions.

Keep the device dry. e device is not waterproof and should not

be submerged under any circumstance. e ingress of liquids may

compromise the safety features of the device. e device is not

intended for use under high sweat conditions. Situations which

may result in the entrapment of sweat around the sensors must be

avoided.

Handle with care. Trigno sensors and instruments are precision

devices and not designed for excessively rugged use. Carefully in-

spect devices prior to each use to ensure that no mechanical dete-

rioration has occurred.

Sensitive electronic device. Avoid static discharges. Do not oper-

ate or store near strong electrostatic, electromagnetic, magnetic or

radioactive elds. 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

performance is noted. Contact Delsys technical support for as-

sistance.

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

the equipment only if assembly, modications 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.

Trigno Spring Contact Adapter User’s Guide6

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

crush, burn, freeze, heat or otherwise mishandle the device. Re-

charge only with the approved power supply and recharger. Sen-

sors should be charged at least once every 3 months to prevent

battery damage from excessive self discharge. Extended periods

in the discharged state may damage the internal lithium polymer

cell.

Trigno Systems should be stored and operated between 5 and 40

degrees Celsius due to the presence of an internal Lithium Poly-

mer rechargeable cell. Storing or operating the device, and conse-

quently the cell, outside of this temperature range may compro-

mise the integrity and the safety features of the cell.

Device Information

Complies with Requirements put forth by the Medical Device Di-

rective 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. is

product should not be mixed with other commercial wastes.

Date of Manufacturing (appears on device)

Serial Number (appears on device)

EMERGO EUROPE

Prinsessegracht 20

2514 AP The Hague

The Netherlands

Authorized Representative Manufacturer

DELSYS INC.

23 Strathmore Rd.

Natick MA 01760

USA

7TrignoTM EMG System

FCC ID: W4P-SP-W03 (Trigno Body Worn Receiver)

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

FCC ID: W4P-SP-W05 (Trigno Sensor)

IC: 8138A-DST02 (Trigno Personal Monitor System)

is device complies with Part 15 of the FCC Rules and Indus-

try Canada’s RSS-210 License Exempt Standards. Operation is

subject to the following two conditions: (1) is device may not

cause harmful interference, and (2) this device must accept any

interference received, including interference that may cause un-

desired operation.

is product complies with FCC OET Bulletin 65 radiation ex-

posure limits set forth for an uncontrolled environment.

Pursuant to Part 15.21 of the FCC Rules, any changes or modi-

cations to this product not expressly approved by Delsys Inc.

might cause harmful interference and void the FCC authorization

to operate this product.

To reduce potential radio interference to other users, the antenna

type and its gain should be so chosen that the equivalent isotropi-

cally radiated power (EIRP) is not more than that required for

successful communication.

is 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. ese limits are designed to provide reasonable protection

against harmful interference in a residential installation. is

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. ere

is no guarantee that interference,will not occur in a particular in-

stallation. If this equipment does cause harmful interference to

radio or television reception, which can be determined by turning

the equipment o 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.

Trigno Spring Contact Adapter User’s Guide8

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 qualied 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 malfunction, wheth-

er 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.

Delsys provides the Trigno Spring-Contact Adapter per request of

the Client and makes no assertions or recommendations on the

type of recording electrode to use, or the method of its applica-

tion. is responsibility befalls the electrode manufacturer, the

Client performing the study and the Institutional Review Board

overseeing the study.

System Requirements

e Trigno Spring Contact Adapter is designed to be used with

Trigno Wireless EMG Systems.

9TrignoTM EMG System

e Trigno Spring Contact Adapter is an accessory to the Trigno

EMG System for these Researchers wishing to detect EMG sig-

nals with alternative methods to those provided by the Trigno

standard contact approach. e main sensor body uses the 4

silver contacts to establish a local electrical reference from which

to measure the EMG signals detected by the spring contacts.

e sensor body includes an onboard ± 1.5g/±6g accelerometer.

Spring Contact Adpater Overview

Figure 1. Spring Contact Adapter- The main body hosts 4 con-

tacts for establishing a local reference, and include an on-board

±1.5g/±6g accelerometer.

spring contacts

recharge contacts

LED status

indicator

power button

reference contacts

sensor head sensor body

Trigno Spring Contact Adapter User’s Guide10

Charging the Sensors

Connect the Trigno power supply to the circular DC jack lo-

cated on the side of the Trigno Base/Recharge Station. Energize

the power supply by connecting it to a Mains outlet. Be sure to

use the appropriate plug adapter for your location. Ensure that

the Trigno sensors are properly tted in the recharge pockets.

e sensor LEDs will illuminate to amber during charging and

green when charge is complete. e recharge unit will periodi-

cally check sensors and apply a top-o charge to ensure that the

battery is kept at full capacity during extended periods of stor-

age, as long as power is connected.

Figure 2. Connecng the SC-P05 power supply to the Sensor

Charge Staon.

Using the Sensors

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