Medi CAD babyDOPPY User manual

babyDOPPY
Ultrasonic fetal heartbeat detector
USER MANUAL
1011
v.: 1.

kiadás: 1
Ultrasonic fetal
heartbeat
detector
Medi-CAD Kft.
3529 Miskolc, Lá ár Vilmos u.
4.
Tel: [phone], 431-395
Fax: [phone]
http://www.medicad.hu/

Contents
Contents 1
1.Fields of application...........................................2
2.Main parts of the device....................................3
3.Measuring fetal heart rate..................................4
4.Checking and charging the battery.....................5
6.Cleaning and disinfection...................................7
7.Environmental and other conditions of the use,
storage and transportation of the device.....8
8.Technical specifications...................................10
9.Contents of the kit...........................................12
10. Repair and maintenance................................13
Declaration of Conformity..................................14
Quality Certificate / Warranty.............................16
kiadás: 1

1. Fields of application
babyDOPPY is a portable, battery-powered, ultrasonic
diagnostic equipment.
Using its 2 MH sensor, human fetal heart activity can be
detected from the second trimester of pregnancy. From then,
the fetal heart rate can be monitored to the end of pregnancy.
On the LCD panel located on the front panel of the unit, the
value of the average fetal heart rate per minute (FHR) is
displayed.
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2. Main pa ts of the device
Sensor
Push button (On/Off switch)
Volume control wheel (VOLUME)
Headphone socket (PHONE)
Sensor/ battery charger connector (PROBE)
LCD display
Charger adapter

    
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3. Measu ing fetal hea t ate
Connect the sensor to the PROBE  socket. Switch on
the device by briefly pressing the push button on the
handle of the sensor. After the unit has been turned on, three
number 8’s appears on the LCD display of the device,
followed by three “-“ characters indicating that the device is
ready to measure fetal heart rate.
The push button does not need to emain p essed during
the examination!
Find the hea t ate of the fetus with the senso of the
device:
•Apply an ample amount of ultrasound gel to
the head of the sensor and move it slowly along the
mother’s abdomen until you can detect a clear,
distinctive fetal heart sound.
•You can achieve the best quality heart sound when the
sensor head is in the most ideal position.
•Avoid positions where strong placenta or umbilical
cord blood flow sounds can be detected.
•If the fetus is in cranial presentation and the mother is
lying on her back, the clearest heart sound can be
found on the midline under the navel.
•It is impossible to obtain fetal heart rate (FHR) if there
is no sufficient quality fetal heart sound present.
•Do not confuse the mother’s heart sound with the heart
sound of the fetus. You can distinguish the fetal pulse
from the mother’s if you feel the mother’s pulse during
the examination.
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If the fetus’ hea t sound is of app op iate quality, the value
of the fetal hea t ate per minute appears on the LCD
display within a few seconds.
By pressing the button on the sensor  again, the unit can be
switched off; the device automatically tu ns itself off after
approx. one minute if not used.
To remove the sensor (e. g. in case of a sensor change or
when the battery charger is connected) press the plastic tab
located on the bottom of the sensor connector and pull out the
connector.
The volume can be adjusted with the VOLUME  control
wheel.
Attention! The volume cont ol wheel is not the on/off
switch; the wheel se ves only to adjust the volume!
DO NOT use salt-containing ECG conductive gels, as they
may harm the sensor!
4. Checking and cha ging the batte y
babyDOPPY is operated by a 9V battery, independently of
the electric network.
The fully charged battery lasts for a total of up to 4 hours of
operation in case of normal signals and use at an average
volume level. Considering the average duration of an
examination for each patient and usual off-time periods, it is
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most probable that one battery-charge will operate the device
for several workdays even if the device is in constant use.
The beginning of low-battery status is indicated by the brief
flash of “Lob” on the LCD display when the device is turned
on or being operated during an examination. The device can
continue to be used at this time. Continued decrease of
battery power is indicated by more frequent flashes of the
“Lob” sign. When the battery power is completely discharged
and is no longer sufficient to operate the device, an “OFF”
sign appears on the display and the device will switch off.
After disconnecting the connector of the ultrasound sensor,
insert the plug of the network charger supplied by the
manufactu e into the socket with the PROBE sign (in
the socket whe e the senso was p eviously connected),
and insert the plug of the charger into the electric network
socket to charge the battery. If the charger was successfully
connected, a brief flash of “Ch ” appears on the display for
two seconds. While the unit is being charged, continuous
succession of “I” characters pass along the LCD display. The
flashing appearance of three “8” characters on the LCD
display indicates that the battery charge has been completed.
Remove the plug of the charger from the main unit and
connect the sensor again; after turning on the device check its
proper operation!
Battery charge is controlled by the internal electronics of the
device, which ensures proper level of battery charge and
prevents overcharging.
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6. Cleaning and disinfection
Use a soft, damp cloth to clean the main unit and the
sensors. Be sure to prevent water or other liquids to
seep in through the gaps or crevices (e. g. speaker grid,
socket, switch) of the main unit and the sensor.
Never submerge the sensor or the main unit in any liquid
(e. g. water, alcohol, oil), as they may be irreparably
damaged!
Attempt to sterili e the device with hot water or steam
may result in the irreparably damage of the sensor and
the unit also!
WARNING! The front face of the sensor and its
surrounding area must be cleaned and disinfected before
each examination! Recommended disinfectants:
Secusept EN, Barrycidal.
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7. Envi onmental and othe conditions of the
use, sto age and t anspo tation of the
device
Tempe atu e data:
Operating temperature: +5 °C - +40 °C
Transportation temperature: -40 °C - +65 °C
Storage temperature: -20 °C - +55 °C
Humidity data:
Operating humidity: 30% - 95 %
Transportation and storage humidity: max. 95 %
(Moisture must not condensate!)
The device must not be exposed to direct sunlight for
more than 10 minutes!
The device must be protected during use, transportation and
storage from impact and other excessive mechanical stress
(e. g. dropping)!
The senso s contain fragile ceramic crystals that may be
destroyed in the event of an impact or drop!
At the end of its life-cycle, the device must not be
t eated as household waste.
At the end of thei life-cycle, the batte ies must be
placed in the collection bins located at
manufactu e o dist ibuto of the batte ies.
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At the end of its life-cycle, the device must be
disposed of at the manufactu e o at collection
sites specialized fo the ecycling and disposal of
elect onic equipment.
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8. Technical specifications
Senso :
Frequency:
[MH ]
Type Nominal
diameter
[mm]
Max. ultrasound
output power:
[mW/cm²]
2±10% DO-02 20 10
Method of hea t ate (FHR) calculation:
Calculated based on the average of 8 heartbeats
Range: 60/min. - 210/min.
Classification:
Device operated by internal power source
BF type patient-side part
Powe supply: 9V rechargeable battery (PP3)
Batte y cha ge :
Primary: 240V-50H
Secondary: 15 VDC; 3.6VA
Only cha ge supplied by the manufactu e may be used!
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Ope ating pe iod: approx. 4 hours (total, with a fully
charged battery)
Dimensions:
main unit: 117 x 78 x 25 mm
sensor: Ø16/Ø 20 x 105 mm
Weight: main unit: approx. 150 g
sensors: approx. 120 – 140 g/each
charger: approx. 70 g
The manufactu e ese ves the ight to change the
specifications!
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9. Contents of the kit
babyDOPY unit 1 pc
Sensor 1 pc
Conductive gel 1 tube
Charger adapter 1 pc
Case 1 pc
User’s manual 1 pc
12

10. Repai and maintenance
The repair and maintenance of the device may only be
performed by Medi-CAD Kft. or its authori ed
technicians.
Address:
Medi-CAD Kft.
3529 Miskolc, Lá ár Vilmos u. 4.
Tel.: [phone], 431-395
Email: [e-mail]
13

Decla ation of Confo mity
We he ewith decla e that above mentioned p oduct meet
the p ovisions of the Council Di ective 93/42/EEC fo
medical devices.
Manufacturer: Medi-CAD Kft.
H-3529 Miskolc, Lá ár Vilmos u. 4.
Hungary
Tel: [phone]
Fax: [phone]
Product:
Ultrasonic fetal heartbeat detector
Type: DOPPY product family:
babyDOPPY
Classification: Class II a.
Notified body:
GYEMSZI
Equipment Evaluation and Hospital Technology Directorate
1125 Budapest
Diós árok u. 3.
1011
July 30, 2013, Miskolc
Barnabás S űcs
CEO
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Quality Ce tificate / Wa anty
Name of Product: babyDOPPY
Serial Nos.:
•Main unit:
•DO-02:
Based on quality inspection performed on the finished product,
the device meets the performance requirements specified in the
User’s Manual.
Miskolc, 201
_________________________
This warranty is valid for the above product for 24 months from
purchase. In case of malfunction, the product is repaired free of
charge within the warranty period.
Main place of performance:
Medi-CAD Kft.
3529 Miskolc, Lá ár Vilmos u. 4.
The warranty does not cover damage or malfunction resulting
from the improper use of or mechanical impact on the device.
Date of purchase:
Distributor (signature and stamp):
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