cigii P612 Ultrasonic Fetal Doppler User Manual

cigii P612 Ultrasonic Fetal Doppler

Product Information Ultrasonic Fetal Doppler

The P612 ultrasonic fetal doppler is a hand-held, battery powered doppler fetal heartrate detector. It is intended to detect and display fetal heart rate, and it is used by healthcare professionals in hospitals, clinics, communities, and homes for singleton pregnancies after 16 weeks gestation. The device is not intended for treatment and it is not explosion-proof. It cannot be used in the presence of flammable anaesthetics. The batteries should not be thrown in fire as this may cause them to explode. Normal dry-cell batteries should not be recharged as they may leak and cause a fire or even explode.

Components of the Device

• Ultrasonic Fetal Doppler
• Battery Cover
• Gel
• User Manual

The following components are including with the package, make sure all the components are complete when you open your new purchase

Battery Installation

1. Open the battery cover located on the back of the device.
2. Insert the two 1.5V AA batteries into the battery compartment following the correct polarity (+/-).
3. Replace the battery cover.

CAUTION Use only 1.5V”AA”alkaline batteries with the device.

1. STEP1-Press the indicator on the battery cover and slide the cover off in the direction of the arrow.
2. STEP2-Install two ”AA” size batteries so the +(positive) and –(negative) polarities match the polarities of the battery compartment as indicated.
3. STEP3- Close the battery cover.

Taking a Detection

1. Apply gel on the probe of the device.
2. Turn on the device by pressing and holding the power button until the device beeps and the LCD screen turns on.
3. Place the probe on the abdomen in the region of fetal heart, and move it slowly until it detects fetal heart rate.
4. The detected fetal heart rate will be displayed on the LCD screen.
5. When done, turn off the device by pressing and holding the power button until the LCD screen turns off and the device beeps.

Before detection
Check whether the device is in good condition and whether there is obvious damage that may affect the safety of pregnant women or the performance of the device; if any damage is found, please stop using it immediately and replace the damaged parts.

Detection Procedure
Follow the steps below for fetal heart rate detection:

1. The pregnant woman lying on bed;
2. Apply an appropriate amount of couplant to the acoustic surface of the ultrasound fetal Doppler;
3. Turn on the power switch;
4. Touch the pregnant woman’s abdomen to determine the position of the fetal;
5. Place the device on the pregnant woman’s abdomen and move or tilt the device slowly within the range of the fetal until hearing clear and rhythmic fetal heart sounds and see a stable fetal heart rate value;
6. After the detection, turn off the device first, and then use a clean soft cloth or paper to wipe off the remaining couplant on the surface of the pregnant woman’s abdomen and the ultrasound head of the device.

CAUTION Do not mistake maternal heart rate as fetal heart rate.

CAUTION  Do not take gloves to operate the buttons. If there is water, couplant and other substances on the surface of the fingers, please clean them first, otherwise the test results will be affected.

Look for the fetal heart rate
Since the fetus moves at any time in the abdomen, the position of the fetal heart is not fixed. You can refer to the uterine fundus height of the following different pregnancy cycles to determine the approximate range of the fetus:

• At the 12th week of pregnancy, the height of the uterine fundus is 2-3 transverse fingers above the pubic symphysis (about 2-3cm).
• At the 16th week of pregnancy, the height of the fundus is between the navel and the pubic bone.
• At the 20th week of pregnancy, the height of the fundus of the uterus is 1 finger below the navel (about 1cm).
• At the 24th week of pregnancy, the height of the fundus of the uterus is 1 finger above the navel (about 1cm).
• At the 28th week of pregnancy, the height of the fundus of the uterus is 3 fingers above the navel (about 3cm).
• At the 32th week of pregnancy, the height of the fundus of the uterus is between the navel and the xiphoid process.
• At the 36th week of pregnancy, the height of the fundus of the uterus is 2 fingers below the xiphoid process (about 2cm).

See the position picture of the fetal heart below:

Care and Maintenance

• Clean the probe after each use with a soft cloth or tissue.
• Store the device in a dry and clean place.
• Replace the batteries when low to ensure accurate detection results.

To keep your ultrasonic fetal doppler in the best condition and protect the unit from damage, follow the directions listed below:

Maintenance

• Before each use, the device must be checked whether has obvious damage that could affect the safety of pregnant women or the performance of the device. If damage is found, make necessary repairs or replacements.
• The accuracy of the fetal heart rate is controlled by the device and cannot be adjusted by oneself. If the fetal heart rate result is not reliable, use other methods such as using a stethoscope to verify, or contact your local agent or manufacturer for assistance.
• The device is a precision instrument and must be handled with care.the excess couplant on the ultrasonic probe must be wiped off after the instrument is used.

Cleaning

• Shut down before cleaning.
• Do not use any abrasive or volatile cleaners.
• Use a soft cloth moistened with neutral soap or 70% isopropyl alcohol to clean the surface of device, and then wipe them with a dry cloth.
• Wipe off excess couplant from the ultrasound probe, clean the ultrasound probe with a soft cloth soaked in mild neutral detergent or 70% isopropyl alcohol, then dry the ultrasound probe with a dry soft cloth.
• Do not wash or immerse your device in water.

Storage
Keep your device in the storage case when not in use. Store your device in a clean, safe location.

Do not store your device:

• If your device is wet.
• In locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapors such as bleach.
• In locations exposed to vibrations or shocks.

Bluetooth Connection

The device can be connected to a Bluetooth-enabled mobile device using the following steps:

1. Turn on the device.
2. Enable Bluetooth on your mobile device.
3. Search for available devices and select “Jamr Fetal Doppler”.
4. Enter “0000” as the password when prompted.
5. The device is now connected and ready to use with compatible mobile apps.

• a ) Install the App from Google play store or Apple app store. Open Bluetooth on smart phone, and then Turn on the App
• b ) Bluetooth pairing for the first time Press the power button to turn on the device and the Bluetooth symbol will flash,then operate bluetooth pairing according to the settings on the APP,The bluetooth symbol will stop flashing after the connection is successful.
• c )Bluetooth paired successfully Bluetooth will be automatically searched and connected when it is powered on.

Troubleshooting

If the device does not work properly, please refer to the troubleshooting guide in the user manual or contact customer support for assistance. Due to operation or other problems, you may not be able to achieve the expected results, please refer to the following troubleshooting measures to solve

Can’t turn on or turn off immediately after turning on

| The battery is low| Replacement battery
Switch on and off the device

without following the instructions

| Long press the switch button to

turn on and off

Device malfunction| Contact customer service to resolve
After power on, the LED shows, but there is no sound from the loudspeaker| The probe did not start working| The device needs to touch the skin probe to start for working
the volume is minimum and no sound| Voice adjustment
Device malfunction| Contact customer service to resolve

Fetal heart rate jumps when detecting fetal heart sounds

| Some strong interference sources, such as high-frequency

device, mobile phones, etc

| Avoid using in environments with strong electromagnetic

interference sources

Pregnant women experience fetal movement and the position of the

fetal heart changes

| Readjust the position of the ultrasound fetal Doppler to find

the best position

Device and belly friction misidentification| Find the best fetal heart position and hear stable fetal heart sounds

When used, the sensitivity is low and the noise is too large

| Some strong sources of interference| Avoid using in environments with strong electromagnetic interference sources
No couplant applied| Add coupling agent
Device was not placed in the optimal fetal heart position| Adjust the position and angle of the ultrasound fetal Doppler on the belly of pregnant women
Device malfunction| Contact customer service to resolve

Technical Specifications

• Type : Ultrasonic Fetal Doppler
• Model : P612
• Battery : 2 x 1.5V AA batteries
• Dimensions : 135mm x 92mm x 29mm
• Weight : 180g (including batteries)
• Operating Temperature : 10°C to 40°C
• Storage Temperature : -10°C to 55°C
• Relative Humidity : < 80%

Operating Environment

| Temperature: 5℃ to 40℃
Humidity: 10% to 80% RH

Storage Environment

| Temperature: -20℃ to 55℃
Humidity: ≤93% RH
Weight| 98.3g
Size| 141x45x45mm

Conformance standard

| IEC 60601-1, IEC 60601-1-2,IEC60601-1-11,IEC 60601-2-37,IEC6126

EMC Declaration

The P612 ultrasonic fetal doppler conforms to the Medical Device Directive 93/42/EEC and has been tested for electromagnetic compatibility (EMC) in accordance with the following standards:

• IEC 60601-1-2 :2014
• CISPR 11: 2015
• CISPR 22: 2008
• EN 55024: 2010
• EN 61000-3-2 :2014
• EN 61000-3-3 :2013

The device is suitable for use in the following EMC environments:

• Residential, commercial, and light-industrial locations
• Hospitals, clinics, and medical centers

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments and so on.

• Warning ：Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
• Warning ： Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Warning : Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.”
• Warning ：Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ultrasonic fetal doppler,model:P612, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity.

Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

The “Ultrasonic Fetal Doppler P612” is intended for use in the electromagnetic environment specified below. The customer or the user of the “Ultrasonic Fetal

Doppler” should ensure that it is used in such an environment.

Emissions test| Compliance| Electromagnetic environment – guidance

RF emissions CISPR 11

| ****

Group 1

| The P612 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| ****

The P612 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Voltage

| ****

Not application

fluctuations/ flicker emissions IEC 61000-3-3| ****

Not application

Table2

Guidance and manufacturer’s declaration – electromagnetic immunity

The “Ultrasonic Fetal Doppler P612” is intended for use in the electromagnetic environment specified below. The customer or the user of the “Ultrasonic Fetal Doppler”

should ensure that it is used in such an environment.

Immunity test| IEC 60601

test level

| Compliance level| Electromagnetic environment – guidance
Electrostatic discharge (ESD)

IEC

61000-4-2

| ****

± 8 kV contact

± 2,4,8,15   kV

air± 6KV indirect

| ****

± 8 kV contact

± 2,4,8,15 kV air

± 6KV indirect

| Floors should be wood, concrete or ceramic tile. If floors are covered with Synthetic material, the relative humidity should be at

least 30 %.

Electrical fast transient/bur st

IEC

61000-4-4

| Signal ports:±1 kV Input a.c. power ports:±2 kV Input d.c. power

ports:±2 kV

| ****

Not application

| ****

Mains power quality should be that of a typical commercial or hospital environment.

---|---|---|---
Surge IEC

61000-4-5

| Line to line:

±1kV,

Line to ground:

±2 kV

| ****

Not application

| Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions

and

voltage variations on power

supply input lines IEC

61000-4-11

| <5% U T

(>95 % dip in

U T)

for 0,5 cycle 40% U T

(60 % dip in U T) for 5 cycles 70% U T

(30 % dip in U T)

for 25 cycles

<5% U T

(>95 % dip in

U T)

for 5 sec

| ****

Not application

| Mains power quality should be that of a typical commercial or hospital

environment. If the user of the“Ultrasonic Fetal Doppler P612” requires

continued operation during

power mains interruptions, it is recommended that the “Ultrasonic Fetal Doppler ” be

powered from an uninterruptible

power supply or a battery.

Power frequency (50/60 Hz)

magnetic field

IEC

61000-4-8

| ****

30 A/m

50Hz/60Hz

| ****

30 A/m

50Hz/60Hz

| ****

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital

environment.

NOTE U T is the a.c. mains voltage prior to application of the test level.

Table3

Guidance and manufacturer’s declaration – electromagnetic immunity

The “Ultrasonic Fetal Doppler P612” is intended for use in the electromagnetic environment specified below. The customer or the user of the “Ultrasonic Fetal Doppler” should ensure that it is used in such an environment.
Immuni ty test| IEC60601

Test level

| Complian ce level| Electromagnetic environment – guidance

Conduc ted RF IEC 61000-

4-6

| ****

3 Vrms

150 kHz

to 80 MHz

| ****

3 V

| Portable and mobile RF communications equipment should be used no closer to any part of the

“ Ultrasonic Fetal Doppler P612”, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance d=1.2√P

d=1.2√P 80MHz to 800MHz d=2.3 √P    800MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,a should

be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment

marked with the following symbol:

---|---|---|---

Radiate d RF IEC 61000-

4-3

| ****

3 V/m

80 MHz

to 2,7 GHz

| ****

10V/m

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land

a   mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site

survey should be considered. If the measured field strength in the location in which the “Ultrasonic Fetal Doppler P612” is used exceeds the applicable RF compliance level above, the Ultrasonic Fetal Doppler P612 should be observed to verify

b   normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the “Ultrasonic Fetal Doppler P612”.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [ V 1] V/m.

Table4

Recommended separation    distances    between    portable    and mobile     RF communications equipment and the Ultrasonic Fetal Doppler P612

The “Ultrasonic Fetal Doppler P612” is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Ultrasonic Fetal Doppler can help prevent electromagnetic interference

by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the“Ultrasonic Fetal Doppler” as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

power of

| Separation distance according to frequency of transmitter

m

transmitter

W

| 150 kHz to 80

MHz

| 80 MHz to 800

MHz

| 800 MHz to 2,5

GHz

---|---|---|---
0,01| 0.12| 0.12| 0.23
0,1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Warranty

The P612 ultrasonic fetal doppler is covered by a one-year warranty from the date of purchase. For warranty service or support, please contact customer support.

Your Jamr Ultrasonic Fetal Doppler is guaranteed for 2 years against manufacturers’ defects for the original purchaser only, from date of purchase. The warranty does not apply to damage caused by improper handling, accidents, professional use, not following the operating instructions or alterations made to the instrument by third parties. Warranty only applies to the instrument. All accessories including the cuff are guaranteed for one year, USB charging cable is not included. There are no user serviceable parts inside. Batteries or damage from old batteries is not covered by the warranty. Note: According to international standards, your monitor should be checked for accuracy every year.

INTRODUCTION

Thank you for purchasing the Jamr Ultrasonic Fetal Doppler. Please read this manual carefully before using the device and save the manual to inspect at any time. The P612 ultrasonic fetal doppler is a hand-held,battery powered doppler fetal heartrate detector. It is intended to detect and display fetal heart rate,and used by health care professionals in hospital,clinic, community and home for singleton pregnancies after 16 weeks gestation. The following symbols appear in the manual or device,understand what these symbol means help you to use the device correctly.

SAFETY INFORMATION

• WARNING Indicates a potentially hazardous situation , if not avoided, which could result in death or serious injury.
• WARNING  The device is is not intended for treatment.
• WARNING  The device is not explosion-proof and can not be used in the presence of flammable anaesthetics.
• 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  Don’t touch signal input or output connector and the patient simultaneously.
• WARNING  Do not use the device during the process of surgical equipment (including high-frequency surgical equipment) and MRI examinations to avoid jeopardizing physician or patient safety.
• WARNING  Don’t dismantle or fix the device by yourself, or use not authorized parts and accessories , otherwise it may result in detection error or damage the device.
• WARNING  If the electrolyte in the battery gets into your eye, please immediately flush with a great deal of clear water, or it will result into to blindness or other harmful danger.
• CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient, or cause damage to the equipment or other property.
• CAUTION  Operate the device only as intended,do not use for any other purse.
• CAUTION  Remove batteries if the device is not likely to be used for 3 month or longer time.
• CAUTION  Don’t use a cell phone for calling near the device, or it may influence the normal function of the device .
• CAUTION  Dispose of device,component and optional accessories according to applicable local regulations. Unlawful dispose may cause environment pollution.
• CAUTION  Don’t subject the device to strong shock like dropping it on the floor, otherwise it may lead to the measurement value of the product incorrect.
• CAUTION  DO NOT disassemble or attempt to repair repair this device or other components by yourself,this may cause an inaccurate reading.
• CAUTION  DO NOT use this device in a moving vehicle such as in a car.
• CAUTION  DO NOT drop or subject this device to strong shocks or vibrations. During .
• CAUTION  DO NOT use this device in high-use environments such as medical clinicsor physician offices.
• CAUTION  DO NOT insert batteries with their polarities incorrectly aligned.
• CAUTION  Remove batteries if this device will not be used for a long period of time.
• CAUTION  DO NOT use batteries after their expiration date.

The symbols on the LCD display

BATTERY REPLACEMENT

Battery Indicator

When appears on the display, turn the device off and remove all the batteries. Replace with four new 2 “AA” size batteries at the same time.

• CAUTION Don’t replace other model AA alkaline battery, otherwise may arouse breakdown.
• CAUTION  Do not mix use new and old batteries , otherwise may cause leakage, fever, fracture of the battery to damage the product.
• CAUTION  Turn the device off before replacing batteries .
• CAUTION  When the batteries are replaced or taken out ,you need to reset the date and time .
• CAUTION  To prevent the damage of device from leaked battery fluid, please take out of battery if the device unused in a long time(generally more than 3 months). If battery fluid should get in your eyes, immediately rinse with plenty of clean water.
• CAUTION  Contact a physician immediately.
• CAUTION  Dispose the useless batteries according to local environment protection regulation

Disposal
Dispose of your device and other components according to applicable local regulations.Unlawful disposal may cause environmental pollution.

CONTACT INFORMATION

Ultrasonic Fetal Doppler P612 is manufactured by: Shenzhen Jamr Technology Co., Ltd. A101-301,D101-201, Jamr Science & Technology Park, No. 2 Guiyuan Road, Guixiang Community,Guanlan Street, Longhua District, Shenzhen 518100, PEOPLE’S REPUBLIC OF CHINA

• Website : www.jiemeirui.com
• Telephone : 0086 755 85292057

Authorized European Representative:
Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany.

• Telephone : +49-40-2513175 /2513178
• FAX : +49-40-255726
• E-mail : [email protected]

FCC Statement

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions

1. This device may not cause harmful interference, and
2. this device must accept any interference received, including interference that may cause undesired operation.

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarant ee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

Caution : Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environm ent. This transmitter must not be co‐located or operating in conjunction with any other antenna or transmitter.

References

• 深圳市捷美瑞科技有限公司 - 深圳市捷美瑞科技有限公司

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