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.
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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
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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.
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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.
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Chapter 3
Outlook and Configuration
Fig. 3-1 Front Panel
Fig. 3-2 Rear Panel
Start/Stop Button
Mode Button
Power Button Probe
LCD
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Speaker
Battery Compartment

27
Fig. 3-3 Top Panel
3.1 Display
The LCD display is as follows:
Fig. 3-4 LCD Display
3.2 Push Button
There are three push button (Power, Mode, and Start/Stop) and a volume control
button on Pocket Fetal Doppler. The primary functions are as follows:
3.2.1 Power Button
Function: Power on/off.
Power on: Push the button once.
Power off: Push down the button and hold 3 seconds to power off.
Headphone
Headphone Socket
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Battery Status
Indicator
Work Mode
FBR Value
FHR Bar Graph
Probe Nominal Frequency
FHR Heartbeat
Waveform

28
3.2.2 Mode Button
Function: Mode selection, press once to enter next working mode under working
status. For the Fetal Doppler has memory function, when turning on the
machine, it will enter the mode selected before last power off automatically after
self testing.
3.2.3 Start/Stop Button
Function: Start/Stop control.
Under model 3, press this button the fetal heart rate counting starts, press this
button again the counting stops.
3.2.4 Volume Control Indicator
Volume adjusting direction indicator.
From left to right means that the sound level is from high to low.
3.3 Headphone Socket
Headphone Socket: a socket for audio output, and can be connected
with earphone or recorder with audio input to record.
The socket, terminal post, or switch that connected with the
headphones. Accessory equipment connected to the analog and digital
interfaces must be certied according M the respective IEC standards (e.g. IEC
950 for data processing equipment and IEC 60601-1 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 IEC60601-1-1. If in doubt, consult
our technical service department or your local distributor.
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29
Headphone Socket Signal Interface:
Fig. 3-5 Headphone Socket for Audio Output
Headphone socket showed as Fig.3-5, the denition of pins showed as below:
Pin Definition
1 Signal
2 Signal
3 Signal
4 Signal
Chapter 4
General Operation
4.1 FHR Inspection
1. Power on by pressing the Power button. The LCD display is as Fig.3-4.
2. Find the position of fetus:
At rst, please feel the position of the fetus by hand. Find out the best direction
for inspecting the fetal heart. Apply a liberal amount of gel to the faceplate of
probe; place the faceplate of probe at the best position for detecting fetal heart.
Adjust the probe to obtain an optimum audio signal ideally by angling the probe
around. Adjust the volume according to requirements.
3. FHR Calculation:
LCD displays fetal heart rate values, bar graph and fetal heartbeat waveform.
4. Turn off the machine:
Keep pressing the power button 3 seconds to turn off.
CAUTION
1. Put the probe on the best detecting position to get better detecting effect.
2. Don’t put the probe on the position where have strong Placental Blood Sound
(PBS) or strong Umbilical Sound (UMS).
1
3
2
4
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30
3. If pregnant woman adopts horizontal position and the fetus position is normal,
put the probe on the position of lower navel midline to get the clearest FHR
sound.
4. Do not measure FHR unless audible fetal sound has been heard.
5. Please reduce the time of ultrasonic radiation as possible as you can.
4.2 Mode Selection
4.2.1 Real-time FHR Display Mode (Mode 1)
The moment when the fetal heart rate signals are detected, the fetal heart rate
bar graph on LCD indicates the strength of the fetal heart rate signals, and
meanwhile shows the fetal heart rate values and fetal heartbeat waveform.
4.2.2 Averaged FHR Display Mode (Mode 2)
This model is able to acquire more stable fetal heart rate, displaying on LCD
the latest acquisition of eight points fetal heart rate on average. When the fetal
heart rate is shown, the fetal heart rate bar graph on LCD indicates the strength
of the fetal heart rate signals, the shown fetal heart rate values and heartbeat
waveform changes slowly.
4.2.3 Manual Mode (Mode 3)
Press the start / stop button starts counting, fetal heart rate reads as “ - - -”,
the moment when the fetal heart rate signals are detected, the fetal heart rate
bar graph indicates the fetal heart rate strength. Once again press the start /
stop button to stop counting, the equipment will automatically calculate
the average fetal heart rate acquired from the beginning to the end, and also
the result will be displayed. Numerical fetal heart rate will always remain until
a repeated measurements or patterns of change.
4.3 Probe Operation
4.3.1 Inspecting Probe
When the probe falls away from the the device, LCD screen displays the “- - -”
and displays “Probe fall !”.The probe frequency data disappeared. At this
moment the probe needs to be reconnected. After connected well, LCD screen
will clear away the “Probe fall !”and display the probe frequency data.
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4.3.2 Replacing Probe
There has been a probe connected to device while packaged by the
manufacturer. If users need to replace it with another probe, power off the device
at rst, then take out the probe from the parking of device. And then pull out
the plug of the probe from its socket. Then connect the plug of the probe which
needs to be displaced with the socket.
Note: Place the temporarily unused probe carefully and avoid falling off,
stress, etc. When the device is not used for a long time, users are
recommended to connect the plug of one probe to device socket and
put the probe in the parking. Then pack the device with the probe
in the wrapping box.
4.3.3 Taking out Probe and Placing Probe
1. Taking Out The Probe
Hold the main unit with one hand, and hold the handle of the probe with another
hand to take out the probe. (See Fig.4-1).
Fig. 4-1 Taking out Probe
2. Placing Probe
It is opposite to take out probe. Hold the main unit with one hand, and hold the
top of the probe with another hand, then push the probe into the probe holder.
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4.4 FHR Alarm
The normal fetal heart rate range is 120 BPM-160 BPM, LCD displays the fetal
heart rate numerical values as green; when the fetal heart rate is too fast or too
slow, beyond the normal range, the fetal heart rate numerical values red alarm
to remind pregnant women to go to hospital for further checks to ensure the
fetal safety.
4.5 Battery Status Indicator
When it works normally, the LCD screen displays the status of the battery
as follows:
Battery power is full
Battery power is not full
Battery power is about to run out, it needs replacing batteries.
When this machine detected the battery power is not able to maintain the
normal working of the system, LCD indicates “Low Power!”, and meanwhile the
battery power state indicative marks is ashing, later the system will
automatically shut down.
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4.6 Replacing Battery
1. The rear panel is upturned. First open the battery compartment, then take out
the battery from the battery compartment (see Fig.4-2).
Fig. 4-2 Replacing Battery
2. Put two AA size batteries into the battery compartment (as for the direction
of battery, please refer to the instruction inside the battery compartment), at last
close the battery compartment.
CAUTION: The battery must be taken out from the battery compartment
if the device will not be used for a long time.
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Chapter 5
KEY OF SYMBOLS
SYMBOL DESCRIPTION
TYPE CF
REFER TO INSTRUCTION MANUAL/BOOKLET
HEADPHONE SOCKET
VOLUME ADJUST
WEEE (2002/96/EC)
EUROPEAN REPRESENTATIVE
SN SERIAL NUMBER
Chapter 6
PRODUCT SPECIFICATION
Product Name: Pocket Fetal Doppler
Safety: Complies with: IEC 60601-1:2005
Classification:
Anti-electroshock Type: Internally powered equipment.
Anti-electroshock Degree: Type CF applied part
Harmful Liquid Proof Degree:
Main unit: Degrees of protection provided by enclosure: IPXO.
Probe: Prevent from water splashing, degree of protection: IPX4.
Degree of Safety in Presence of Flamrnable Gases: Equipment not suitable
for use in presence of ammable gases.
Working System: Continuous running equipment.
EMC: Group I Class B.
Suitable Using Range: Suitable for use after the 12th week of pregnancy.
Physical Characteristic
Size: 135mm (Length) X 92mm (Width) X 29 mm (Height)
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Weight: About 245g (including batteries)
Environment
Working:
Temperature: +5°C~+40°C
Humidity: <80%
Atmospheric Pressure: 70 kPa~106 kPa
Transport and Storage:
Temperature: -10°C~+55°C
Humidity: ≤93%
Atmospheric Pressure: 50 kPa~106 kPa
Display: 1.77”262K TFT display
FHR Performance
FHR Measuring Range: 50-240BPM (BPM: beat per minute)
Resolution: 1BPM
Accuracy: +-2BPM
Power Consumption: <1 W
Auto Shut-OFF: After 1 minute no signal, power off automatically.
Battery Type Recommended: Two pieces of 1.5 V DC battery (SIZE AA LR6).
Probe:
Nominal Frequency: 2.0MHz
Working Frequency: 2.0 MHz±10%
P-: < 1 MPa
Iob: < 20 mW/cm2
Ispta: < 100 mW/cm2
Ultrasonic Output Power: P < 20 mW
Working Mode: Continuous wave doppler
Effective Radiating Area of Transducer: < 157mm2
Note: In all working application modes, mechanical index: MI<1, thermal
index: TI<1.
Chapter 7
Maintenance
7.1 Maintenance
The probe acoustic surface is frangible and must be handled with care.
Gel must be wiped from the probe after use. These precautions will prolong
the life of the unit.
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The user must check that the equipment does not have visible evidence of
damage that may affect patient safety or Pocket Fetal Doppler capability before
me. The recommended inspection interval is once per month or less. If damage
is evident, replacement is recommended before use.
The equipment should undergo periodic safety testing to insure proper
patient isolation from leakage currents. This should include leakage current
measurement. The recommended testing interval is once every two years or as
specied in the institution’s test and inspection protocol.
The accuracy of FHR is controlled by the equipment and can not be adjusted
by user. If the FHR result is distrustful, please use other method such as
stethoscope to verify immediately or contact local distributor or manufacturer
to get help.
7.2 Cleaning
Before cleaning, switch off and take out the batteries.
Keep the outside surface of the device clean and free of dust and dirt, clean
exterior surface (display screen included) of the chassis with a dry, soft cloth.
If necessary, clean the chassis with a soft cloth soaked in a solution of soap,
or water and wipe dry with a clean cloth immediately.
Wipe the probe with soft cloth to remove any remaining ultrasound coupling gel.
Clean with soap and water only.
CAUTION: Don’t use strong solvent, for example, acetone.
CAUTION: Never use an abrasive such an 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
Note: Wipe the surface of probe with 70% ethanol, self-air dry, or clean with
a clean, dry cloth.
7.3 Disinfecting and Sterilization
Clean the equipment case, probe, etc. as above, and then wipe the probe with
an alcohol impregnated wipe (70% ethanol).
Wipe the probe with a clean, dry cloth to remove any remaining moisture.
NOTE:
1. The recommended periods of cleaning, sterilization and disinfecting is once
per month.
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2. After cleaning, sterilization and disinfecting, users must inspect whether
have any obvious damage which may affect the patient safety and instrument
performance.
WARNING: Never try to sterilize the probe or equipment by low temperature.
Chapter 8
SOLUTIONS FOR POSSIBLE PROBLEMS
If it appears following problems when you use the device, please solve them
as below:
Problems Possible reasons Solutions
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Weak sound
Noise
Low
sensitivity
• Volume is too low
• Power is low
• Did not daub the gel
• Probe is too near from
the main unt
• Disturbance from the
outside signal
• Power is low
• Position of the probe
is not correct
• Did not daub the gel
• Adjust the volume louder
• Change the battery
• Daub the gel
• Make the distance between
the probe and the main
unit a little further
• Keep far away from
the outside signal
• Change the battery
• Adjust the position
of the probe
• Daub the gel

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Appendix 1
Essentiality of Fetal Domestic Monitor
Modem medicine think that:
FHR is an important gist to identify fetal health, by recording FHR changes
can observe fetal hypoxia, fetal distress and the umbilical cord around the neck,
and other symptoms. Fetal domestic monitor test FHR rate changes by listening
to fetal heart sound mainly. Fetal domestic monitor is a powerful guarantee to
improve generational safety. Fetal heart rate changes most obviously in the
following three periods:
• Within 30 minutes after pregnant women get up
• Within 60 minutes after pregnant women nish lunch
• Within 30 minutes before pregnant women go to bed
For the above three periods, because of the change of the body status
of pregnant women, the activity of food digesting needs the body to provide
more oxygen, relatively, the oxygen for fetus become less. It is easy to arose
symptoms such as fetus anoxia. Testing the FHR at this time can display
the healthy status for the fetus best.
The above three periods can only be tested at home by pregnant women
themselves, so FHR domestic monitor is very important. We advise the pregnant
women to measure every day respectively at early, middle and late time, every
time measuring the fetal heart rate and listening to the fetal heart rate for about
one minute, and recording the measurement results for the medical reference
when go to the hospital.
Generally, the medicine deems the normal fetal heart rate as: 120BPM~160BPM;
slightly too fast: 161BPM~180BPM; heavily too fast: above 181BPM; slightly too
slow: 119BPM~100BPM; heavily too slow: below 99BPM.
This device can hear the fetal heart sound for fetus above twelve weeks,
and check the LCD display. Finding too fast or too slow should go to hospital
for further checks to ensure safety.
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C=20 log10
(
)

39
Appendix 2
Overall Sensitivity
ENGLISH
Diameter of Target Reector (mm) 1.58 A=45.7dB@ 2MHz 2.38 A=43.2dB@ 2MHz
Distance
(d)
(mm)
Reection
Loss
A(d)
T 20 4.8 4.0 - Ba40 9.6 8.0 - T 20 4.8 3.4 - Ba40 9.6 6.8 - T 20 4.8 3.4 - Ba40 9.6 6.8 - T 20 4.8 - - Ba40 9.6 - - T 20 4.8 3.4 2.2 Ba40 9.6 6.8 4.4 T 20 4.8 3.4 1 Ba40 9.6 6.8 2 T 20 4.8 3.4 - Ba40 9.6 6.8 - T 20 4.8 1 - Ba40 9.6 2 -
Bw
(dB)
B
dB
Vs
r.m.s
mV
Vn
r.m.s
mV
0 57.6 186 94 5.93 109.2 0 56.4 175 90 5.78 107.8 0 56.4 174 89 5.82 107.9 0 49.6 173 90 5.68 100.9 0 60.8 178 89 6.02 110.0 0 58.4 170 90 5.52 107.1 0 56.4 165 85 5.76 105.3 0 51.6 160 85 5.49 100.2
50 45.7 75 45.7 100 45.7 200 45.7 50 43.2 75 43.2 100 43.2 200 43.2
Two-way Attenuation
B=
∑
Ba+Bw
∑
Ba
(T:mm Ba:dB)
Overall
Sensitivity
(S=A(d)+B+C)
dB
C=20 log10
(
)
Vs(r.m.s)
Vn(r.m.s)
dB
Doppler Frequency
(Hz)
333 12.5Velocity
of Target
(cm/s)

40
ENGLISH
Disposal: The product must not be disposed of along with other
domestic waste. The users must dispose of this equipment by
bringing it to a specific recycling point for electric and electronic
equipment. For further information on recycling points contact
the local authorities, the local recycling center or the shop where
the product was purchased. If the equipment is not disposed
of correctly, fines or penalties may be applied in accordance
with the national legislation and regulations.
GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product. This product meets high
qualitative standards both as regards the material and the production.
The warranty is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace free
of charge all the defected parts due to production reasons.
Labor costs and personnel traveling expenses and packaging not included.
All components subject to wear are not included in the warranty.
The repair or replacement performed during the warranty period shall not extend
the warranty. The warranty is void in the following cases: repairs performed by
unauthorized personnel or with non-original spare parts, defects caused by
negligence or incorrect use.
GIMA cannot be held responsible for malfunctioning on electronic devices or
software due to outside agents such as: voltage changes, electro-magnetic
elds, radio interferences, etc. The warranty is void if the above regulations are
not observed and if the serial code (if available) has been removed,
cancelled or changed.The defected products must be returned only
to the dealer the product was purchased from. Products sent to GIMA
will be rejected.