Gima Sonoline C 29480 User manual

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
DOPPLER PORTATILE CON SCHERMO A COLORI
COLOUR SCREEN POCKET DOPPLER
ÉCRAN PORTATIF COULEUR DOPPLER
PANTALLA DE COLOR PORTÁTIL DOPPLER
MONITOR A CORES DETECTOR DOPPLER
DE BOLSO
FARBBILDSCHIRM-TASCHENDOPPLER
Manuale d’uso - User manual - Manuel de l’utilisateur
Guía de uso - Guia para utilização
Gebrauchs- und instandhaltungsanleitung
M-29480-M-Rev.0.07.18
PROFESSIONAL MEDICAL PRODUCTS
ATTENZIONE: Gli operatori devono leggere
e capire completamente questo manuale
prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read
and completely understand the present manual
before using the product.
AVIS: Les opérateurs doivent lire et bien
comprendre ce manuel avant d’utiliser le produit.
ATENCIÓN: Los operadores tienen que leer y entender
completamente este manual antes de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender
completamente este manual antes de usar o produto.
ACHTUNG: Diese Anleitung muss vor dem Einsatz des
Produkts aufmerksam gelesen und vollständig verstanden werden.
29480 / Sonoline C
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street, Economic & Technical
Development Zone, Qinhuangdao, Hebei Province,
PEOPLE’S REPUBLIC OF CHINA
Made in China (P.R.C.)
Shanghai International Holding Corp. GmbH (Europe)
Eiestrasse 80, 20537 Hamburg, Germany
0123

22
Attention
This user manual is written and compiled in accordance with the council
directive MDD93/42/EEC for medical devices and harmonized standards.
In case of modications and software upgrades, the information contained
in this document is subject to change without notice.
The manufacturer makes no warranty of any kind with regard to this material,
including, but not limited to the implied warranties of merchantability and tness
for a particular purpose. The manufacturer assumes no responsibility for any
errors that may appear in this document, or for incidental or consequential
damage in connection with the furnishing, performance or use of this material.
No part of this document may be photocopied, reproduced or translated to
another language without prior written consent of the manufacturer.
The information contained in this document is subject to change without notice.
Responsibility of the Manufacturer
The manufacturer only considers itself responsible for any effects on safety,
reliability and performance of the equipment if:
Assembly operations, repairs are carried out by persons authorized by the
manufacturer, and the device is used in accordance with the instructions for use.
WARNING:
This device is not intended for treatment. The intended use is for detecting Fetal
Heart Rate. If the fetal heart rate (FHR) result is distrustful, please use other
methods such as stethoscope to verify immediately.
Warranty
The unit can not be repaired by users themselves. All services must be done
by the engineers approved by manufacturer. We warrant that each product we
sell you is free from defects in labor and materials and shall conform to its
product specications as dened in the user documentation. If the product
doesn’t function as warranted during the warranty period, we will repair or
replace it without charge. Misuse, improper maintenance may void the warranty.
Using This Label Guide
This guide is designed to give key concepts on safety precautions.
WARNING:
A WARNING label advises against certain actions or situations that could result
in personal injury or death.
CAUTION:
A CAUTION label advises against actions or situations that could damage
equipment, produce inaccurate data, or invalidate a procedure.
Note: A NOTE provides useful information regarding a function or procedure.
ENGLISH

23
Chapter 1
Safety Guidance
This unit is internally powered equipment and the degree of shock protection
is type CF applied part . Type CF protection means that these patient
connections will comply with permitted leakage currents, dielectric strengths
of IEC 60601-1.
WARNING and CAUTION messages must be observed. To avoid the possibility
of injury, observe the following precautions during the operation of the device.
WARNING: This device is not explosion-proof and can not be used in the
presence of ammable anaesthetics.
WARNING: Do not throw batteries in re as this may cause them
to explode.
WARNING: Do not attempt to recharge normal dry-cell batteries, they may
leak, and may cause a re or even explode.
WARNING: Don’t touch signal input or output connector and the patient
simultaneously.
WARNING: Accessory equipment connected to the analog and digital
interfaces must be certied according to the respective IEC standards (e.g.
IEC 950 for data processing equipment and IEC60601-1 for medical
equipment). Furthermore all congurations shall comply with the valid
version of the system standard IEC60601-1-1. Everybody who connects
additional equipment to the signal input connector or signal output
connector congures a medical system, and is therefore responsible
that the system complies with the requirements of the valid version of the
system standard IEC 60601-1-1. If in doubt, consult our technical service
department or your local distributor.
WARNING: Pocket Fetal Doppler is a tool to aid the healthcare professional
and should not be used in place of normal fetal monitoring.
WARNING: Replacing battery shall only be done outside the patient
environment (1.5m away from the patient).
CAUTION: The device must be serviced only by authorized and qualied
personnel.
CAUTION: The main unit is designed for continuous operation and is
‘ordinary’. Do not immerse in any liquid (i.e. not drip or splash-proof).
CAUTION: Keep the device clean. Avoid vibration.
CAUTION: Do not use high temperature sterilizing process and E-beam
or gamma radiation sterilization.
CAUTION: Electromagnetic Interference-Ensure that the environment
in which the device is operated is not subject to any sources of strong
ENGLISH

24
electromagnetic interference, such as radio transmitters, mobile telephones,
etc. Keep them far away.
CAUTION: The user must check that the equipment does not have visible
evidence of damage that may affect patient safety or monitoring capability
before use.
The recommended inspection interval is once per month or less. If damage
is evident, replacement is recommended before use.
CAUTION: The following safety checks should be performed once every
two years or as specied in the institution’s test and inspection protocol
by a qualied person who has adequate training, knowledge, and practical
experience to perform these tests.
• Inspect the equipment for mechanical and functional damage.
• Inspect the safety relevant labels for legibility.
• Verify that the device functions properly as described in the instructions for
use.
• Test the patient leakage current according to IEC 60601-1: Limit: 10 uA (CF).
The leakage current should never exceed the limit. The data should be recorded
in an equipment log. If the device is not functioning properly or fails any of the
above tests, the device has to be repaired.
CAUTION: The battery must be properly disposed: The battery must be
properly disposed according to local regulation
CAUTION: The device shall only be used if the battery cover is closed.
Battery must be stored in cool and dry piace.
If use rechargeable battery, to insure capability and life, please fully charge
batteries before rst use, normally, batteries must be continuously charged
over 14 hours or charged according to the guidance displayed on the bat-
tery.
CAUTION: Please don’t set anode and cathode of the battery wrongly.
CAUTION: The valid period of this product is ve years.
After the service life, please return the products to the manufacture or
disposeal the products according to local regulations.
When cleaning the machine:
CAUTION: Don’t use strong solvent, for example, acetone.
CAUTION: Never use an abrasive such as steel wool or metal polish.
CAUTION: Do not allow any liquid to enter the product, and do not
immerse any parts of the device into any liquids.
CAUTION: Avoid pouring liquids on the device while cleaning.
CAUTION: Don’t remain any cleaning solution on the surface of the device.
ENGLISH

25
When disinfecting the machine:
WARNING: Never try to sterilize the probe or equipment by low
temperature steam or other methods.
Refer to accompanying documents.
Chapter 2
INTRODUCTION
2.1 Overview
Pocket Fetal Doppler is a hand-held obstetrical unit, which can be used
in hospital, clinic and home for daily self-check by pregnant woman.
The device uses color LCD of high resolution to display the fetal heartbeat
waveform, and gure out the FHR to help the doctor diagnose in time.
It contains components of ultrasonic signal transmitter and receiver, analog
signals processing unit, FHR calculating unit, LCD display control unit etc.
It has 3 work modes: real-time FHR display mode, averaged FHR display mode,
and manual mode. It also has audio output, and can be connected with
earphone or recorder with audio input.
2.2 Features
• Beautiful shape, portable, easy operation.
• The probe has bending structure which is easy to operate and can increase
the ease of the pregnant women, embodies the human care design.
• Fetal heart rate values, bar graph and heartbeat waveform color screen
display.
• Alarming in red when the fetal heart rate range is out of the norma! range.
• Battery status indicator.
• The probe can be changeable.
• Probe inspection.
• Built-in speaker.
• Output for headphone.
• Auto shut off.
• Two pieces of standard 1.5V alkaline battery available which can work no less
than 8 hours.
ENGLISH