Gima GIMASONIC Baby Sound C1 Use And Maintenance Book

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 modifications 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
fitness 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 doubtful, please use
other methods such as stethoscope to verify immediately.
Warranty
The unit cannot be repaired by users themselves. All services must be done by the engineers approved by the manufacturer. We guarantee that each
product we sell to you is free from defects in labor and materials and shall conform to its product specifications as defined in the user documentation. If
the product does not function as specified 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.
: This item is compliant with Medical Device Directive 93/42/EEC of June 14, 1993, a directive of the European Economic Community
Chapter 1 Safety Guidance
This unit is an 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 flammable anesthetics.
WARNING: Do not throw batteries in fire as this may cause them to explode.
WARNING: Do not attempt to recharge normal dry-cell batteries, they may leak, and may cause a fire or even explode.
WARNING: Do not touch signal input or output connector and the patient simultaneously.
WARNING: This device is a tool to aid the healthcare professional and should not be used in place of normal fetal monitoring.
WARNING: Please use the probe provided by the manufacturer.
WARNING: Do not pull the line of probe longer than 2m, to avoid disconnecting the probe from the device connector.
WARNING: Keep out of reach of children - The device contains small parts that can easily be swallowed.
WARNING: Equipment can not be repaired and maintained during use.
WARNING:The patient is an intended operator.
CAUTION: The device must be serviced only by authorized and qualified personnel.
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
electromagnetic interference, such as radio transmitters, mobile telephones, etc. Keep them far away.
CAUTION: Before use, care must be taken to ascertain that the equipment is free from damage that may affect patient safety or monitoring capability.
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 specified in the institution's test and inspection protocol by a
qualified 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 must be repaired.
CAUTION: The battery must be properly disposed of, according to local regulation after their use.
CAUTION: The battery must be taken out from the battery compartment if the device will not be used for a long time.
CAUTION: Patients can replace the battery.
CAUTION: The device shall only be used if the battery cover is closed.
CAUTION: Battery must be stored in a cool and dry place.
CAUTION: Do not set anode and cathode of the battery wrongly.
CAUTION: The typical service life of the new and unused batteries is 300 measurements for the operation time is 60s.
CAUTION: The valid period of this product is five years.
CAUTION: After the service life, please return the products to the manufacture or dispose of the products according to local regulations.
CAUTION: This device can not be used with a defibrillator or high frequency surgical unit.
CAUTION: Please choose the accessories authorized by our company or the device may be damaged.
CAUTION: Please keep the probe from edge tool.
CAUTION: Please use this device under recommended environmental conditions without strong electromagnetic field, which may influence usage
results.
CAUTION: The material of the shell and ultrasound probe of the device is ABS, in line with ISO 10993-5& ISO 10993-10.
CAUTION: Protect the device against extreme moisture, heat, and direct sunlight.
Chapter 2 Introduction
2.1 Overview
Pocket Fetal Doppler is a hand-held obstetrical unit, which can be used in hospital and clinicfor daily self-check by pregnant woman.
The device uses color LCD of high resolution to display the fetal heartbeat waveform, and figure 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.
◆Aesthetic design, portable, easy operation.
2.2 Features
◆The probe has a flexible structure which is easy to operate and can increase comfort for pregnant women during use, thereby demonstrating the humane
◆Fetal heart rate values, bar graph and heartbeat waveform color screen display.
care design.
◆Battery status indicator.
◆2 MHz/3 MHz ultrasound probe can be connected.
◆ 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.
Chapter 3 Outlook and Configuration
F i g . 3 - 1 F r o n t p a n e l
3.1 Display
The LCD display is as follows:
3.2 Push Button
There are three push buttons (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 for 3 seconds to power off.
3.2.2 Mode Button
Function: Mode selection, press once to enter next working mode under working status.
The Fetal Doppler possesses a memory function. When the machine is turned on, 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 for connection to earphones or recorders with audio input to record.
3.4 Ultrasound Probe
The meanings of CD-- IP-- on the label are as follows:
C: The work mode for the probe is continuous wave.
D: The structure form for the probe is cell type.
2.0/3.0: The frequency of the probe is 2 MHz or 3MHz.
IPX4: Harmful Liquid Proof Degree.
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:
To start, feel the position of the fetus by hand. Determine 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 appropriate 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 most appropriate detecting position to get better detecting results.
② Do not put the probe on the position where Placental Blood Sound(PBS) or Umbilical Sound (UMS) is very strong.
③ For pregnant women adopting a horizontal position and the fetus position is normal, position the probe on the lower navel midline to get the clearest
FHR sound.
④ Do not measure FHR unless audible fetal sound has been heard.
⑤ Reduce the time of ultrasonic radiation as much 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 is disconnected from the device, the 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.
4.3.2 Replacing Probe
A probe is connected to the device by the manufacturer. If users need to replace it with another probe, power off the device, then take out the probe from
the device before pulling out the plug of the probe from its socket. Afterwards, 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.
① Taking Out the Probe
4.3.3 Taking Out Probe and Placing 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).
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.
4.4 FHR Over Range Remind
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 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:
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
①The rear panel is upturned. First open the battery compartment, then take out the battery from the battery compartment (See Fig.4-2).
4.6 Replacing Battery
②Put 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.
F i g . 3 - 2 R e a r p a n e l
Chapter5 Key of Symbols
Fig.3-3 Top panel
: The socket, terminal post, or switch that can headphones can be connected to.
F i g . 3 - 5 U ltrasound probe
Fig.4-1 Taking out Probe
Battery power is about to run out, it needs replacing batteries.
is flashing, later the system will automatically shut down.
Symbol Description
Fig.3-4 LCD display
Fig.4-2 Replacing Battery
Battery power is full
Battery power is not full
Symbol Description