Doppler fetale
Fetal Doppler
Doppler fœtal
Doppler Fetal
Gima S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) Italy
Italia: tel. 199 400 401 - fax 199 400 403
Export: tel. +39 02 953854209/221/225 fax +39 02 95380056
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
EU Repre-
sentative
MANUALE D’USO E MANUTENZIONE
USE AND MAINTENANCE BOOK
INSTRUCTIONS DE FONCIONNEMENT ET ENTRETIEN
MANUAL DE USO Y MANTENIMIENTO
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.
GIMA S.p.A.
Via Marconi, 1 20060 Gessate (MI) Italy
Made in P.R.C.
M29506MRev.2.03.15
0476
15 ENGLISH
Instructions for Safe Operations
- Check the device to make sure that there is no visible damage that may affect
user’s safety and measurement performance about the main unit and probe. When
there is obvious damage, stop using the device.
- Necessary service must be performed by qualied service engineers ONLY. Users
are not permitted to repair it by themselves.
- The Doppler cannot be used together with the devices not specied in User
Manual.
Cautions
- Explosive hazard—DO NOT use the Doppler in the environment with inammable
gas such as some ignitable anesthetic agents.
- DO NOT use the Doppler while the testee is under MRI or CT scanning.
- Do NOT throw the battery into re, or explosion will occur.
- To dispose the device or its accessories, the local law must be followed.
- It is recommended that the device is operated by or under the guidance of
professional personnel such as nurse and midwife etc.
Attentions
- High temperature or autoclave sterilization to the Doppler is not permitted. Refer
to related chapter for instructions of cleaning and disinfection.
- The intended use of this device is not for therapy purpose.
1. Overview
1.1 Appearance
Figure 1 Fetal Doppler (Front View)
ENGLISH
Key Introduction
There are 5 keys on the front panel
Denitions:
Long-pressed: some keys pressed for longer than 2 seconds
Short-pressed: some keys pressed for no longer than 2 seconds
FHR display mode: including numerical value display mode and curve display mode
(Power/Back): Power on/off the device by longtime pressing; short time press it to
1.
return to upper level operation.
(Recall/Backlight): short time press it to turn on/turn off the backlight; the backlight will
2.
be off in 3 seconds after pressing this key.
3.
(Mode/OK): press this key, the screen can be shifted between numerical value display
mode and curve display mode; longtime press it, the menu setup screen will be displayed,
and then when you nish parameter setting press this key to conrm.
4. Navigation Key
- (Up/Left/Increase): in the numerical value display mode, press this key, the fetal heart
beat volume will be turn up; on menu screen, press this key to shift cursor.
-
(Down/Right/Decrease): in the numerical value display mode, press this key, the fetal
heart beat volume will be turn down; on menu screen, press this key to shift cursor.
5. Display screen: display FHR curve and parameter values.
6. Data Interface: used for uploading data;
7. Earphone jack: fetal heartbeat sound can be also output to an ear phone by this jack
8. Doppler probe: ultrasound transducer for detecting FHR.
9. Probe connector:connecting the detachable doppler probe.
16
1.2 Model and Name
29506 Fetal Doppler
1.3 Structure
The Fetal Doppler comprises two main parts: probe and main unit, connected by a retractile
cable.
1.4 Intended Use
The Fetal Doppler is intended for detecting and recording the Fetal Heart Rate (FHR). It is
applicable for use in clinics and homes, and convenient to operate by the patients themselves.
This Fetal Doppler is a handheld device which is used for spot-checking the fetal
heart rate. It can NOT be a substitute of the regular fetal monitor.
1.5 Features
Fetal Doppler is a handheld portable device for FHR detection. Its operation is easy and
convenient for pregnant women to use in daily examination
- LCD display with LED backlight.
- Handheld device, small in size and convenient for hand-carry
- Built-in speaker and audio output.
- Auto power off if no signal is detected in one minute.
- Audible & visual alarms and the alarm limits can be set.
- For easier maintenance, ultrasonic probe is detachable.
17
- Low battery voltage indication.
- Can be powered by rechargeable batteries or AC-DC adapter (optional).
- Can be used as a portable easyfetal monitor with optional 1.0 MHz Fetal Monitor probe
- Up to 15 hours data memory and trend curve recall.
- Data upload to a PC for further storage and analysis.
- 50-seconds real-time doppler sound recording and replay.
2. Installations of Battery and Holder
1) Open the rear panel with coin or an ordinary at screwdriver, as shown in Figure 2.
2) According to the polarity mark, insert three AA batteries into battery compartment, as
shown in Figure 3.
3) Close the battery cover and lock it.
4) Fixing Holder (gure 4).
Note: Do NOT insert batteries with their polarities reversed.
ENGLISH
Figure 2 Figure 3 Figure 4
3. Operation
3.1 Start the Fetal Doppler
3.1.1 Numerical Value Display Mode
Connect the doppler probe to the probe connector. Press the power button
2 seconds or longer) to start the device, and then it enters numerical value display screen
(see the following gure).
Figure 5 Numerical Value Display Screen
(lasting for
ENGLISH
Screen Description
- “FHR”: Fetal Heart Rate icon.
- “158”: the fetal heart rate value (unit: bpm, beats per minute), it will shows‘---’ when no signals.
”: the speaker volume, 8 levels, “0~7” eight levels adjustable.
- “
- “Nov. 08, 07”: date displayed by MM. dd, yy pattern
- “10:05:25”: time displayed by hh-mm-ss pattern.
- “ ” battery power indicator.
Note: After power on, the display mode will be the same as the mode displayed
when power off last time.
3.1.2 Trend Curve Display Mode
In numerical value display mode, press the mode button to enter into the trend curve display
mode as shown in the gure below.
Figure 6 Trend Curve Display Mode
18
Screen Description
- “50-210”: FHR scale.
- “:21”: when starting doppler sound recording, the recording time will be shown. “21” indicates
the recording has been activated for 21 seconds.
- “|”: Vertical cursor, shift to right once a minute.
- “
”: Alarm icon; it will appear when the Doppler alarms.
- “FHR” Fetal Heart Rate; “142” is the current FHR. It will shows‘---’ when no signals
- “10:05:25” : the current time.
3.2 Probe Placement
1. To nd the position of fetal heart
Feel out the fetal contour with hand
to nd the approximate position of
fetal heart. Generally, fetal heart
is at a location 1/3 of the lower
abdomen (below the navel) during
short pregnant weeks, and along
with the pregnant weeks increasing,
it moves upwards and lean to right or
lean to left. Refer to Figure 7A and
Figure 7B for proper use method.
Figure 7A Standing Posture Figure 7B Lying Posture
19
Note: It is recommended that the device is operated by or under the guidance of
professional personnel such as nurse or midwife etc.
Before locating the position of fetal heart, you may daub the acoustics surface of
the probe with drinking water instead of ultrasonic gel, and then choose the proper
posture for the optimal probe location.
2. Daub ultrasonic gel
Daub the acoustic surface of Doppler probe uniformly with the appropriate ultrasonic gel, and
then put the probe on pregnant woman’s abdomen (a location near fetal heart). Make sure
that probe contacts surface completely. (If there is no ultrasonic gel, you can use drinking
water to replace it temporarily.)
3. Adjust the location of probe
Change probe location and adjust its angle to obtain optimal FHR sound signal (clear sound
and less noise). When hear the regular sound of fetal heartbeat, the numeral value of FHR
displays on LCD at the same time.
Operating Instruction
- Navigation key
(Up/Left/Increase): press it one time to adjust the volume of doppler sound and turn it up.
Longtime press it for doppler sound recording
(Down/Right/Decrease): press it one time to adjust the volume of doppler sound and turn
it down
(Recall/Backlight): press it to turn on/turn off the backlight; the backlight will be off in 3
-
seconds after pressing this key; longtime press it for entering into recall list screen
-
(Mode/OK): Press it to shift the display modes; longtime press this key to enter into setup
menu screen (as shown in Figure 8).
ENGLISH
3.3 Setup Menu
On the numerical value or trend curve display mode, press “
menu setup screen as shown in Figure 8.
Figure 8 Menu Screen
Operating Instruction
Press Navigation key to select “SETUP”, “SEND TO PC” or “ERASE ALL DATA”, and then
press “
Press “
” (the mode key) to enter into corresponding submenu.
” to exit from MENU.
” (the mode key) to enter into
20ENGLISH
3.3.1 Setup
Figure 9 Menu Setup Screen (A) Figure 9 Menu Setup Screen (B)
Operating Instruction
1. DATE: Date setting
1) When cursor stays on the Month of the date, press “
cursor ashes on the Month of the date.
2) Press Navigation key to adjust Month.
3) Press “
4) The procedures of adjusting Day value and Year value are the same with Month adjustment.
Date Format: mm, dd, yy.
” key to conrm and exit from date setting.
Note: The setting operations of other parameters (such as TIME, CONTRAST,
ALARM etc.) are the same with date setting.
“ key to activate Month option, the
2. TIME: Time setting
3. CONTRAST: LCD Contrast setting
4. ALARM: When the setting is “ON”, the device stays in alarm status and the alarm icon
displays on the upper right display screen.
5. ALARM HI/LO: Alarm High/Low limit setting
When the detected FHR value exceeds the alarm high/low limit, the Doppler will alarm (if
alarm setting is “ON”) and there will be an alarm icon “
6. Press “
3.3.2 Send to PC
When upload data to your computer, please let the device stay in “SEND TO PC” status.
” to back to menu screen.
Figure 10 “SEND TO PC” status
” below the waveform.
21 ENGLISH
3.3.3 Delete All Data
Figure 11 Delete All Data
Press Navigation key to select “Yes”, and then press “
records.
3.4 Sound Recording
On the numerical value or trend curve display mode, long time press “ ” key, the to enter
into menu screen as shown in Figure 12.
Figure 12
Press Navigation key to select “Yes”, and then press “
selection. The 50-seconds doppler sound recording will start and the previous sound recording
will be overwritten by the new recording.
3.5 Recall List
On the numerical value or trend curve display mode, longtime press “
recall list screen. If the record is accompanying with doppler sound recording, there will be a
sound recall icon before the record.
” (the mode key) to delete all the
” (the mode key) to conrm your
” for entering into
Figure 13 Recall list
ENGLISH
Operating Instructions:
Press navigation key to choose a piece of record in the record list (herein choose the fourth
record as an example) and press “
screen will display the recalled trend curve, as shown in Figure 14.
Press the navigation key to move displayed trend graph on screen in order to view different
parts of them. Short time press “
If this record is accompanying with doppler sound recording , short time press “
recorded doppler sound. The display screen is shown below.
” (the mode key) to conrm the selection, the display
Figure 14 Recall Screen
” to back to recall list screen.
22
” to play
Figure 15
Screen Description:
: sound recall icon. :23 the replay time is 23 seconds.
12:50:35: initial time of trend graph displayed on this screen.
004: Record No.
Short time press “
” to back to recall list screen.
“
4. Technical Specication
1. FHR
FHR measuring range: 50~210bpm
FHR resolution: 1bpm
FHR accuracy: ±1bpm or 1%, whichever is greater.
2. Doppler probe
Working mode: Pulse wave Doppler
Ultrasonic working frequency: 1MHz; accuracy: ±2%
” to stop playing sound. When the sound is played over, short time press
23
3. Acoustic Output
According to the requirement of standard IEC 1157:1992 and IEC 61266:1994, the parameters
of acoustic output for 29506 should be declared in the following by the manufacturer:
Nominal acoustic working frequency: 2.0MHz;
Overall sensitivity: >=90dB (measured at the distance of 200mm away from the surface of
probe with Doppler shift frequency of 333Hz and the velocity of target at 12.5cm/s)
Maximal peak negative pressure (P-max): < 1MPa
Output intensity of acoustic beam (Iob): <20mW/cm2
Spatial-peak time-average acoustic intensity (Ispta): < 100mW/cm2
Effective area of the ultrasonic transducer active element: >= 400mm2
4. Power Supply Requirement
Power supply: 3 x AA size batteries
Supply voltage range: 3.6VDC~4.8VDC
Operating current: <150mA
5. Loudspeaker output power: 1W
6. Auto Power-off Function: Power off automatically if no FHR signal is detected for longer
than 1 minute.
7. Classication
The type of protection against electric shock: Internally powered equipment
The degree of protection against electric shock: With Type BF applied parts
The degree of protection against harmful ingress of liquid: Ordinary equipment without
protection against ingress of water.
Electro-Magnetic Compatibility: Group I, Class B
ENGLISH
8. Environmental
Operating Temperature: 5°C to 40°C.
Relative Humidity: 30% to 80% non-condensing
Atmospheric Pressure: 70~106kPa
5. Dimensions and Weight
1. Overall Dimensions and Weight
Dimension: 230 mm (L) × 160 mm (W) × 70 mm (H)
Weight: 310g±10g (including batteries)
2. Accessories
AA battery Three pieces
Detachable ultrasonic probe One piece
Holder One piece
Ultrasonic gel One bottle
User Manual One copy
Note: The accessories are subject to change. Detailed items and quantity see the
Packing List.
ENGLISH
6. Working Principle
This Doppler tests the fetal heart rate through non-invasive ultrasonic Doppler Effect. As is
known, ultrasonic wave propagating at a given frequency will be reected when encountering
an obstacle.
If it is still an obstacle, the back wave will share the same frequency with the transmitted
wave. Once the obstacle moves, the frequency of the back wave will be changed. The higher
rate the object moves at, the bigger frequency change will take place. This is the so-called
Doppler Effect. With the apparatus, the ultrasonic probe is placed on the abdomen of the
pregnant woman. The ultrasonic probe can perceive the fetal heartbeat. When the transmitted
wave encounters the fetal heart, the back wave will develop offset frequency. With the offset
frequency, the fetal heart rate and frequency can be worked out.
7. Maintenance and Service
7.1 Maintenance
The service life (not a warranty) of this deviceis 5 years. In order to ensure its long service
life, please pay attention to the use of maintenance.
1. The acoustics surface of Doppler probe is extremely precise and must be placed carefully.
Wipe off the superuous coupling liquid on the probe. This can prolong the use life.
Please take out the batteries if the unit is not to be used for a long time.
2. Check the device (especially for the Doppler probe, probe cable and probe connector)
before use to make sure that there is no crack or visible damage that may affect measurement
performance.
If there is crack on the probe or visible damage on the device, please stop using and change
the damaged part before use.
3. DO NOT operate the button on front panel with sharp materials.
4. Keep the Doppler away from dust, vibration, corrosive substances, explosive materials,
high temperature and moisture.
5. If the Doppler gets wet, please stop using it. When it is carried from cold environment to
warm and humid environment, please do not use it immediately.
24
7.2 Cleaning and Disinfecting Instruction
Always keep Doppler clean and away from dust. Surface-clean sensor with a soft cloth by
wetting with a solution such as 75% isopropyl alcohol, if low-level disinfection is required,
use a 1:10 bleach solution.
Then surface-clean by a dampened cloth and let it air dry or wipe it with a cloth.
Do NOT perform autoclave sterilization to the Doppler.
Do NOT let any liquid cleaner ow into the device and let any part of device
immerge into the liquid.
Do NOT use electron beam or ?-ray to disinfect.
7.3 Storage and Transportation
Storage environment: Ambient temperature: -20°C~60°C
Relative humidity: 10%~95%
Pneumatic pressure: 50~107.4kPa
Transportation: This Doppler should be transported by land (vehicle or railway) or air in
accordance with the contractual terms. Do not hit or drop it with force.
25
8. Troubleshooting
No Display on the Screen
1. Press the power button for two seconds to turn on the power, if no display on the screen
or the Doppler can not turn on, please open the battery cover, and then check whether the
lithium batteries are installed or inserted properly. If there are no batteries or the batteries do
not make good contact with metal spring patch, please reinstall them.
Abnormal FHR
2. Neither the sound of fetal heartbeat nor the FHR graph can be obtained, please check
the probe whether it is in the right position or at the right angle and check whether there is
ultrasonic gel;
3. The sound of fetal heartbeat can be heard, but the FHR graph is disordered or just sometimes
displays well, maybe the probe is located at the side of fetus’s abdomen. Please adjust the
position of probe.
4. The FHR graph presents abnormal curve after quickening or the posture change of pregnant
woman. Due to the position of fetal heart changes, the position of probe deviates from the
position of fetal heart.
5. Ultrasonic gel becomes less after a long time used, which leads that the probe can not
work well. Please add ultrasonic gel timely.
6. Sometimes the fetus goes down and circumrotates, and the fetus will in occiput posterior
position. It is more difcult to monitor because the back of fetus moves to the backside of
mother’s body. Naturally, the probe can not move to the fetal back, so sometimes place the
probe at the position bellow navel and in the middle of abdomen will be better.
7. If there is a disconnection phenomenon occurs on the screen and it occurs quite frequently,
which reects the probe is not located at the optimal position.
8. If FHR is low or inaccurate after a period monitor, there are two main reasons:
1) the pregnant woman moves during the detection period, the Doppler probe excursion
occurs, therefore the probe is not located at the optimal position.
2) the fetus moves. The detected FHR value is deemed to be invalid.
9. During the detection procedure if FHR can be obtained, but no regular sound of fetal
heartbeat, maybe you don’t nd the proper position. The detected at this moment is the
movement of pulse or umbilical cord bloodstream. If an optimal position still can not be found
after detecting carefully, then the further examinations should be done by doctor, thus to
observe whether the fetus is in good condition.
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 specic 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, nes or penalties may be applied in accordance with
the national legislation and regulations.
ENGLISH
ENGLISH
Appendix-Key of Symbols
Symbol Description
26
Battery Indicator
Sound Volume Icon
Alarm Icon
Power/Back Key
Mode/OK Key
Recall/Backlight Key
Data interface
Earphone jack
Navigation key
0476
CE mark
Date of manufacture
Attention read the warning notices
Type BF applied part
according to the Directive 93/42/EEC and further amendments
Serial number
Manufacturer
Disposal of device according to WEEE regulations 2012/19/EU
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.
Loading...