Huntleigh IRT10 Manuel utilisateur
Wireless Tympanic
Thermometer
IRT10
3
Table of Contents
Contents
1. General Safety Information................................................5
1.1 Warnings / Cautions ............................................................................................. 5
2. Introduction ........................................................................6
2.1 Features of the IRT10 Wireless Themometer................................................ 6
2.2 Intended Use.................................................................................................. 7
2.2 Contraindications ........................................................................................... 7
2.4 About This Manual ......................................................................................... 7
3. Description of Controls, Indicators, Symbols and
Displays ..............................................................................8
3.5 Thermometer Controls and Display .............................................................. 8
3.2 Description of Symbols / Indicators................................................................ 9
4. Setup...................................................................................11
4.1 Unpacking and Inspection.............................................................................. 11
4.2 List of Components ........................................................................................ 11
4.3 Connecting the Thermometer to the host ...................................................... 11
4.4 Installing the Batteries.................................................................................... 12
4.5 Pairing the Thermometer and Main Unit ........................................................ 12
5. Using the Thermometer .....................................................13
5.1 Temperature Measurement............................................................................ 13
6. Care & Cleaning..................................................................15
6.1 General .......................................................................................................... 15
6.2 Returning the IRT10 Thermometer and System Components....................... 15
6.3 Service ........................................................................................................... 15
6.4 Periodic Safety Checks.................................................................................. 15
7. Troubleshooting..................................................................16
7.1 General .......................................................................................................... 16
7.2 Obtaining Technical Assistance ..................................................................... 16
8. Electromagnetic Compatibility ..........................................17
9. Specifications .....................................................................21
9.1 Equipment Classification ............................................................................... 21
9.2 Standards....................................................................................................... 21
9.3 General .......................................................................................................... 21
9.4 Environmental ................................................................................................ 22
9.5 Measurement Parameters ............................................................................. 22
10. Warranty & Service ..........................................................23
10.1 Service Returns ............................................................................................. 23
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Table of Contents
Notice
This document contains proprietary information that is protected by copyright. All Rights
Reserved. Reproduction, adaptation, or translation without prior written permission is prohibited,
except as allowed under the copyright laws.
Warranty
The information contained in this document is subject to change without notice.
Huntleigh Healthcare Ltd makes no warranty of any kind with regard to this material, including,
but not limited to, the implied warranties or merchantability and fitness for a particular purpose.
Huntleigh Healthcare Ltd shall not be liable for errors contained herein or for incidental or
consequential damages in connection with the furnishing, performance, or use of this material.
Revision History
The documentation part number and revision number indicate its current edition. The revision
number changes when a new edition is printed in accordance with the revision history of the
documentation. Minor corrections and updates which are incorporated at reprint do not cause
the revision number to change. The document part number changes when extensive technical
changes are incorporated.
© Huntleigh Healthcare Ltd
All rights reserved
The IRT10 is in conformity with the Medical Devices Directive 93/42/EEC as
amended by 2007/47/EC and has been subject to the conformity assurance
procedures laid down by the Council Directive.
Manufactured in the UK by Huntleigh Healthcare Ltd.
As part of the ongoing development programme the company reserves the right
to modify specifications and materials without notice.
Smartsigns®and Huntleigh are registered trademarks of Huntleigh Technology
Ltd.
© Huntleigh Healthcare Ltd. 2017
5
1. General Safety Information
This section contains important safety information related to general use of the IRT10
wireless thermometer. Other important safety information appears throughout the manual
Important! Before using this equipment, please study this manual carefully and
familiarise yourself with the controls, display features and operating techniques.
Ensure each user fully understands the safety and operation of the unit, as
misuse may cause damage to the unit or injury to the user or patient.
1.1 Warnings / Cautions
General warning / caution Refer to Instructions for Use
WARNING: Check the equipment prior to use and ensure its safe and
proper use.
WARNING: Before use, carefully read directions for use, including all
warnings, cautions, and instructions.
WARNING: If the battery shows any signs of damage, leakage, or
cracking, it must be replaced immediately, by a qualified service person,
and only with a battery approved by the manufacturer.
WARNING: The monitor is intended only as an adjunct in patient
assessment. It must be used in conjunction with clinical signs and
symptoms.
WARNING: It is possible that any radio frequency transmitting
equipment and other sources of electrical noise such as cellular
phones, due to close proximity or strength of a source, may result in
disruption of performance.
CAUTION: U.S. Federal law restricts this device to sale by or on the
order of a licensed healthcare practitioner.
General Safety Information
6
2. Introduction
WARNING: The Wireless Tympanic Thermometer is intended only as an
adjunct in patient assessment. It must be used in conjunction with clinical
signs and symptoms.
This manual contains information about the Wireless Tympanic Thermometer (Order
code: IRT10).
It is available as an option for the SC300 SPOT CHECK Vital Signs Monitor.
2.1 Features of the IRT10 Wireless Themometer
Physical
The IRT10 wireless tympanic thermometer is a clinical grade hand held thermometer
indicated for the intermittent measurment of body temperature in patients of all ages.
Electrical
The Thermometer is powered by two AAA dry cells.
Display
The Thermometer presents the following information on the integrated display:
• Battery status
• Lens cover indicator
• Wireless pairing status
• Temperature measurment
• Measurement scale °C or °F
General Safety Information
7
2.2 Intended Use
The Thermometer is intended for use by trained healthcare professionals in healthcare
settings to measure human body temperature in patients of all ages.
It uses an infra red technique to measure the amount of infrared energy reflected from the
tympanic membrane.
2.2 Contraindications
The Thermometer should not be used if the following situations are present:
Do not use the thermometer if there is any blood or drainage in the ear canal.
Do not use the thermometer if the patient presents with inflamatory condition of the ear
canal.
Do not use the thermometer if the ear canal is blocked with cerumen.
Do not use the thermometer if ear drops or medication has been applied to the ear
2.4 About This Manual
Read the entire manual including the Safety Information section, before you operate the
monitor.
General Safety Information
8
3. Description of Controls, Indicators,
Symbols and Displays
3.5 Thermometer Controls and Display
1
2
3
4
5
6
1 Temperature probe status indicator
2 Start measurment
3 Display
4 Infra red sensor
5 Lens ejector
6 Battery compartment
Introduction
9
Key Function / Display
Battery status
Lens filter status
Wireless status
Scale ºC or ºF
Measurement
3.2 Description of Symbols/ Indicators
The symbols and Indicators are described as follows:
Symbols Description
Attention, consult accompanying documents.
Battery charging indicator lamp
Refer to instructions for use
IPX1 Protection against vertically falling water drops
Date of manufacture
SN Serial number
Introduction
10
Symbols Description
Conformité Européenne Complies with medical device directive 93/42/
EEC
Disposal instructions
Manufacturer
This way Up
Fragile – Handle with care
Limit of stacking layers
Keep dry
Description of Controls, Indicators, Symbols and Displays
11
4. Setup
WARNING: The IRT10 Wireless Thermometer is a prescription device and is
to be operated by qualified personnel only. It is designed for use by medical
clinicians.
WARNING: Discarded battery may explode during incineration. Follow local
government ordinances and recycle instructions regarding disposal or recycling
of device components, including batteries. Do not dispose of batteries in refuse
containers.
4.1 Unpacking and Inspection
The Thermometer is shipped in one carton. Examine the carton carefully for evidence
of damage. Contact Huntleigh Healthcare Ltd Service Department immediately if any
damage is discovered. Return all packing material and Thermometer. Refer to the
Maintenance section for instructions on returning damaged items.
4.2 List of Components
Quantity Item Quantity Item
1 Thermometer 1 Lens covers
2 AAA dry cells 1 Cradle
4.3 Connecting the Thermometer to the host
To facilite ease of use, the Thermometer can be fitted to the SC300 using the cradle
supplied.
Description of Controls, Indicators, Symbols and Displays
Table des matières
