Huntleigh SonicaidOne User manual

User guide
Guide de l’utilisateur
Benutzerhandbuch
Manuale dell'utente
Guía del usuario
Brukerveiledning
sonicaid
ONE
Fetal Heart Detector
Détecteur cardiaque fœtal
Fetal-Herz-Detektor
Rilevatore del battito cardiaco fetale
Detector cardiaco fetal
Fosterlyddetektor

User guide
Guide de l’utilisateur
Benutzerhandbuch
Manuale dell'utente
Guía del usuario
Brukerveiledning
sonicaid
ONE
Fetal Heart Detector
Détecteur cardiaque fœtal
Fetal-Herz-Detektor
Rilevatore del battito cardiaco fetale
Detector cardiaco fetal
Fosterlyddetektor
740306-3

2 SonicaidOne User Guide
UK:
Huntleigh Healthcare, Diagnostic Products
Division, 35 Portmanmoor Road,
Cardiff CF24 5HN, UK
Tel: [phone]
Fax: [phone]
Email: [e-mail]
www.huntleigh-diagnostics.com

SonicaidOne User Guide 3
Contents
Classification and explanation of symbols .................................... 5
Intended use............................................................................ 5
Copyright ................................................................................ 6
The SonicaidOne explained ........................................................ 7
Description .............................................................................. 9
Examination............................................................................. 9
Using a headset (optional)........................................................11
Using the SonicaidOne for water births.......................................11
Battery fitting or replacement ...................................................11
Servicing ................................................................................12
Preventive maintenance ...........................................................13
Accessories and consumables....................................................13
Warranty................................................................................14
Environmental conditions..........................................................14
Disposal of equipment..............................................................15
Electrical interference suppression.............................................15
Specifications..........................................................................16
Ultrasound safety considerations and data ..................................17

4 SonicaidOne User Guide
The SonicaidOne has been designed and manufactured by Huntleigh Healthcare,
an international company with an enviable reputation for innovation and quality
of its products.
The SonicaidOne is CE marked in accordance with the
European Council Directive 93/42/EEC concerning
medical devices.
Huntleigh Healthcare has been certified by Lloyd’s
Register Quality Assurance (LRQA) as an approved
medical devices manufacturer as meeting the require-
ments of BS EN ISO 9001, BS EN 46001 and the Medical
Devices Directive (93/42/EEC).
The SonicaidOne has been independently tested and successfully approved to
the following medical safety standards:
EN 60601-1/
IEC 60601-1
Medical Electrical Equipment Part 1:
General Requirements for Safety
EN 60601-1-2/
IEC 60601-1-2
Standard for electromagnetic compatibility
requirements for medical electrical equipment
UL 2601-1
American standard for safety for medical
electrical equipment
CAN/CSA-C22.2
No. 601.1
Canadian standard for safety for medical electrical
equipment
JIS T 0601-1
Japanese standard for safety for medical electrical
equipment
EN61157/IEC 1157
Requirements for the declaration of the acoustic
output of medical diagnostic ultrasonic equipment
Caution: in the USA federal law restricts this device to sale by, or on the
order of, a physician

SonicaidOne User Guide 5
Classification and explanation of symbols
Type of protection against electric
shock
Internally powered equipment.
Degree of protection against electric
shock
Type B applied part.
Method of sterilization or
disinfection
Main unit and probe: not suitable for
sterilization; disinfect with 70%
ethanol or isopropyl alcohol.
Suitability for use in the presence of
flammable anesthetics
Not suitable.
Mode of operation
Continuous.
This symbol indicates a Type B applied part
This symbol indicates: refer to accompanying documents
Definition: this symbol indicates that this product comes under the
provisions of EU Directive 2002/96/EC on waste electrical and
electronic equipment (WEEE) and that this unit was placed on the
market after 12 August 2005. This directive covers EOL (end-of-life)
disposal.
Rules for the User: within the EU, at end-of-life, this product may be
disposed of only through a government approved collection scheme or
treatment facility. If in doubt contact your local Sonicaid
representative.
Intended use
The SonicaidOne is a portable battery-operated detector designed for the early
detection of fetal life and confirmation of continued life during pregnancy and
labour.
Limitations on use
The SonicaidOne is for use only by qualified medical personnel, and for use only
on intact skin.

6 SonicaidOne User Guide
Copyright
All rights reserved. This guide contains proprietary information which is
protected by copyright and may not be copied in whole or in part except with
the prior written permission of Huntleigh Healthcare. The copyright and the
foregoing restrictions on the copyright use extend to all media in which this
information may be preserved.
This copy of the SonicaidOne User Guide shall be used only in accordance with
the conditions of sale of Huntleigh Healthcare or its distributors.
Huntleigh Healthcare makes no representations or warranties of any kind
whatsoever with respect to this document. Huntleigh Healthcare disclaims all
liabilities for loss or damage arising out of the possession, sale or use of this
document.
Sonicaid®is a registered trademark of Huntleigh Healthcare in the UK and
other countries.
Huntleigh Healthcare
Diagnostic Products Division
35 Portmanmoor Road
Cardiff CF24 5HN, UK
Tel: [phone]
Fax: [phone]
Email: [e-mail]
www.huntleigh-diagnostics.com

SonicaidOne User Guide 7
The SonicaidOne explained
Key
1 On/off button
2 Display
3 Controls
4 Loudspeaker
5 Probe cable
6 Probe
The display
1 Fetal heart rate
2 Heartbeat/confidence indicator
3 Battery low indicator
Controls
1 Manual count button
2 Volume down
3 Volume up
When you press a button, there is an audible beep.

8 SonicaidOne User Guide
Key:
1 Probe holder
2 Battery compartment cover
3 Battery compartment
release catch
1 Headset socket
1 Probe holder

SonicaidOne User Guide 9
Description
The SonicaidOne operates at a nominal frequency of 2MHz, using Doppler ultra-
sound to detect the fetal heart. The fetal heart may be detected from early
pregnancy, but more easily in pregnancies later than 15 weeks gestation. It is
light, fits comfortably into a pocket, and is suitable for
use in the antenatal or labour period. A headset is an optional extra.
The SonicaidOne has a waterproof probe and cable. The main unit is not
waterproof. The SonicaidOne is suitable for labour use, and for use in the
clinical management of water births, provided the main unit is kept dry.
Examination
Caution:
1 Use the SonicaidOne only on intact skin.
2 Take care at all times not to drop the unit.
3 Always inspect the unit for damage prior to use.
Notes:
Always use ultrasound gel between the transducer face and the mother’s
abdomen.
To ensure that the signal detected is fetal in origin, always take the maternal
pulse prior to attempting fetal heart detection.
During very early pregnancy, it is often difficult to obtain the fetal heartbeat. If
you do have difficulty finding a signal, please try not to alarm the patient.
Reassure her that this is quite normal.
1 Apply a small amount of ultrasound gel to the probe face.
2 Switch on by holding down the green button for 2 or 3 seconds.
3 In early pregnancy:
place the probe face on the medial line just above the symphysis pubis with
moderate pressure; tilt slowly in various directions until the heart beats are
heard. If no beats are detected, move the transducer a few centimetres
higher and repeat the procedure. Note that the patient should be advised, if
possible, to have a full bladder as this would facilitate the transmission of
ultrasound.