Hailife FD-01B User manual

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About this Manual
P/N: 01.54.0005
Rev: V1.1
Release Date : Octomber, 2017
Product information
Product Name: Fetal Doppler
Model: FD-01B, FD-01
Brand: Hailife
Manufacturer: Shenzhen Hailife Technology Co.,Ltd.
Address: 501，Block 6，Jinghuazhong Industrial Park，No.2, Jinlong Road, Longgang
District, Shenzhen , Guangdong Province, China
Postcode: 518100
Telephone Number：[phone]
Fax: [phone]
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING advises against certain actions or situations that could result in personal injury
or death.
CAUTION
A CAUTION 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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Table of content
Section 1:Instruction.................................................................................................................. 1
1.1INTENDED USE ................................................................................................................................1
1.2 PRODUCT DESCRIPTION ..................................................................................................................1
1.3 OPERATION PRINCIPLE .................................................................................................................... 1
1.4 CONTRAINDICATIONS FOR USE ....................................................................................................... 2
1.5 ADVERSE EFFECTS .......................................................................................................................... 2
Section 2: Safety Precautions .................................................................................................... 2
Section 3: Symbols.................................................................................................................... 4
Section 4: Doppler Introduction ................................................................................................ 4
4.1. MAIN UNIT....................................................................................................................................4
4.2. FEATURES ......................................................................................................................................5
4.3. ACCESSORIES .................................................................................................................................6
4.4. APP “MYWINE” ............................................................................................................................6
Section 5: Operation Instruction................................................................................................ 7
5.1. OPEN THE PACKAGE AND CHECK ....................................................................................................7
5.2. INSTALL /REPLACING BATTERY ................................................................................................... 9
5.3. DOWNLOAD APP “MYWINE ”AND INSTALL ................................................................................10
5.4. SWITCH ON...................................................................................................................................11
5.5. OPEN APP.................................................................................................................................... 11
5.6. EXAMING .....................................................................................................................................12
5.7. FHR RECORDING,PLAYING AND SHARING..................................................................................13
5.8. COMPLETING EXAMING ............................................................................................................... 15
Section 6: Maintenance .......................................................................................................... 15
6.1. MAINTENANCE.............................................................................................................................15
6.2. CLEANING....................................................................................................................................15
Section 7: Warranty and Service ............................................................................................ 16
7.1. WARRANTY..................................................................................................................................16
7.2. SERVICE .......................................................................................................................................16
Section 8: Product Specifications.......................................................................................... 17
Section 9: Troubleshooting...................................................................................................... 18

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Section 1:Instruction
1.1Intended Use
The Fetal Doppler is a hand-held, battery powered audio Doppler device used for detecting
the sound of the fetal heartbeat (SFH). FD-01B, the product with Bluetooth feature, can also
record the trend line of the fetal heart rate(FHR).
1.2 Product Description
The Fetal Doppler is a lightweight, portable detector. It is designed to meet your detecting
and hearing needs by providing advanced detecting functions and a full range of sound of
the fetal heartbeat.
The Fetal Doppler is mainly used to detect the fetal heartbeat rate (FHR) and the sound of
the fetal heartbeat (SFH).
The growth and development of a fetus can be found out through examination of these
indices. It is applicable for department of gynaecology and obstetrics and clinic daily.
In accordance with classification criteria in Annex IX on “Medical Device Directive
93/42/EEC”, the product is class IIa based on rule 10, “Devices for Direct Diagnosis or
Detection on physiological process”.
1.3 Operation principle
Ultrasonic wave is transmitted from one piezoelectric ceramic at the front of the probe to
the uterus of the pregnant women. Echo is received by the other piezoelectric ceramic at the
front of the probe when ultrasonic wave reaches the fatal heart. Then it is converted into
voltage. This Doppler signal is detected and demodulated from the received signal. And the
Doppler frequency is consistent with the rhythm of the fetal systole and diastole. Once
cardiac valves vibrate and a Doppler frequency excursion is formed. It is transmitted an

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output signal of cardiac valves vibrating, and it is sent to the headphone for getting a
rhythmical sound with the fetal heartbeat. Simultaneously, it is sent to a counter which
calculate periods of heartbeat that is fetal heartbeat rate (bpm=beat per minute).
1.4 Contraindications for Use
Normally none, as a particular case, please consult your doctor.
1.5 Adverse effects
No adverse effect
Section 2: Safety Precautions
The Doppler is internally powered equipment, and it is an IEC/EN 60601-1-1 Type BF
applied part. Type BF protection means that the connection between the equipment and the
personal complies with permitted leakage currents and dielectric strength of IEC/EN 60601-
1-1.
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the device.
1. Do not transfer or repair the device without permit.
2. The user should read this manual before using this device.
3. Do not use the device with High Frequency surgical equipment.
4. The Doppler is not explosion-proof and can’t be used in the presence of flammable
anesthetics.
5. Make sure that your hand is clean and dry before touching the power button.
6. Do not connect any equipment or accessories that are not approved by the manufacture
7. Do not heat or throw batteries in fire as this may cause explosion.
8. Do not short-circuit the batteries or install the batteries reversely.
WARNING

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9. Batteries have life cycles. The alkaline batteries are intended to be use once. If the
battery life is end, replace them according to the identical specifications.
10. Remove the batteries and store them in a cool and dry environment if the device is not
used for a long time.
11. Do not mix the battery with metal objects during storage to avoid short-circuit.
12. The device shall only be used when the battery cover is closed.
13. Stop using the battery if abnormal heat, odor, discoloration, deformation or other
abnormal condition is detected during use or storage. Please dispose it according to the
local regulations.
14. The Doppler is not intended for treatment
15. The waterproof design is followed to the standard IEC529 and compliance to IP22. If
the gel or any other liquids are split on or into the product, please wipe it off
immediately with a soft dry cloth or clear it up with cotton bud.
16. Do not operate the product in the presence of flammable gases to avoid possible
explosion or fire hazard.
1. Keep the Doppler in a clean environment and avoid vibration during storage
2. Clean the surface of the device with non-corrosive detergent.
3. Do not sterilize the Doppler with autoclave or gas.
4. The maximum operational range for Bluetooth connection between the product and a
Bluetooth device is approximately 15 meters (45 feet). Out of the range the product
may not work normally, please use it in valid range.
5. The Doppler and accessories shall be disposed according to local regulations after their
useful lives. Alternatively , they can be returned to manufacture for recycling or proper
disposal.
6. Exposing the Product to extreme environmental conditions outside of its operating
parameters may compromise the ability of the Product to function properly.
7. It should not be used in life supporting or life sustaining applications
8. Federal law restricts this device to be sold by or on the order of a physician or
practitioner licensed by state law in which he/she practices to use or order the use of the
device.
9. Do not continuous use the Doppler over 20 minutes.
CAUTION

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Section 3: Symbols
No. Symbol Definition
1 CE marking
2
Operation instructions
3
Caution
4
RYPE BF APPLIED PART
5 Serial Number
6 Batch code
7
Date of manufacture
8
Manufacturer
9
Authorized Representative in the European
Community
10
General symbol for recover/recyclable
11
Refer to User Manual
( Background: Blue; Symbol: White )
12
Collect separately from other household waste
13
Federal Communication commission
Section 4: Doppler Introduction
Note:
The pictures and interfaces in this manual are for reference only
4.1. Main Unit

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Figure 1 Appearance
1 2 3 4
Power Button Power Indicate Probe Battery Cover
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4.2. Features
Feature FD-01B FD-01
Bluetooth v4.0 Y N
APP Y N
Power indication Y Y
Earphone Output Y Y
Record fetal heart beat sound and
curve Y N
History data sharing Y N
Battery low indication Y Y
Fetal heart beat detection Y Y
Fetal heart sound curve & data
display on APP Y N

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*Note: Y means the product support the feature, N means the product don’t have this
feature.
4.3. Accessories
No. Item Amount FD-01B FD-01
1 User manual 1 pcs Y Y
2 Product qualification certificate 1pcs Y Y
3 Earphone 1pcs N Y
4 Battery , AA LR6 1.5V 2pcs Y Y
5 Ultrasound gel 1pcs Option Option
*Note: “Y” means the accessory is included in the product, “N” means the accessory is
excluded in the product.
*Note: Ultrasound gel is an option for user, or bought from the local distributer while
needed.
4.4. APP “Mywine”
* Note: the section is only available for the product with Bluetooth support. Please
ignore the section if the product doesn’t support the feature.

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Figure 2 Figure 3
Figure 2: User login page
Figure 3: Home page
Section 5: Operation Instruction
NOTE:
To ensure that the Doppler works properly, please read this chapter and the chapter “ Safety
Precautions “ before operation.
The Doppler can detect the fetal heart beats after 16 weeks gestation.
5.1. Open the package and check
Open the package, check for any mechanical damage, check the accessories are all in
according to the packing list. If there is any problem, contact us or your local distributor
immediately.