EDAN SD2 USER MANUAL Pdf Download (2024)

SD2 Ultrasonic Pocket Doppler User Manual

About this Manual

P/N: 01.54.459245

MPN: 01.54.459245010

Release Date:Mar. 2022

Statement

This manualwill help you understand the operation and maintenance of the product better. It is reminded

that the product shall be used strictly complying with this manual. User's operation failing to comply with

this manual may result in malfunction or accident for which Edan Instruments, Inc. (hereinafter called

EDAN)cannot be held liable.

EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials

contained inthis manual shall not be photocopied, reproduced or translated intoother languages.

Materialsprotected by the copyright law, including but not limited to confidential information such as

technical information and patent informationare contained in this manual, the user shall not disclose such

information to any irrelevant third party.

The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or

license to use any of the intellectualproperties of EDAN.

EDAN holds the rights to modify, update, and ultimately explain this manual.

Responsibility of the Manufacturer

EDAN only considers itself responsible for any effect on safety, reliability and performance of the

equipment if:

Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons

authorized by EDAN, and

The electrical installation of the relevant room complies with national standards, and

The instrument is used in accordance with the instructions for use.

EDAN will make available on request circuit diagrams, component part lists, descriptions, calibration

instructions, or other information that will assist service personnel to repair those parts of the equipment

that are designated by EDAN as repairable by service personnel.

Product Information

Product Name:Ultrasonic Pocket Doppler

Model:SD2, SD2Pro, SD2 Plus, SD2 Lite, SD2 Basic

Terms Used in this Manual

This guide is designed to give key concepts on safety precautions.

WARNING

AWARNING label advises against certain actions or situations that could result in personal injury or

death.

CAUTION

A CAUTIONlabel 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 a procedure.

⚫ Safety Precautions

CAUTION

Federal (U.S.) Law restricts this device to sale by or on the order of a physician

NOTE:

This user manual is written to cover the maximum configuration. Therefore, your model may or

may not have some of the parameters and functions described, depending on what you have

ordered.

This unit is internally powered equipment, and it is an IEC/EN 60601-1 Type BF applied part.

Type BF protection means that the connection between the equipment and personnel complies

with permitted leakage currents and dielectric strength of IEC/EN 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

1 It is to be used by health care professionals and patients on the order of a physician.

2 Before the SD2 is prescribed for home use, the user (patient) must be instructed/trained in

proper use of the equipment.

3 Home fetal heart rate detection has not been shown to prevent the onset of preterm labor nor

will it prevent the occurrence of preterm birth.

4 The Doppler is a tool to aid the user in hospitals, clinics or at home and should not be used in

place of normal fetal detection. It is not intended for treatment or use during labor and delivery.

5 Placement of the ultrasound transducer on the abdomen is critical to obtaining the fetal heart

beat as opposed to maternal heart beat or other abdominal noise. The user should be trained

in proper placement techniques either through acceptable Ob/Gyn training and individual

state accreditation, or as being prescribed by such a trained clinician and trained in device

placement.

6 This device is not explosion-proof and cannot be used in the presence of flammable

anesthetics.

7 Magnetic and electrical fields are capable of interfering with the proper performance of the

device. For this reason, make sure that all external devices operated in the vicinity of this

device comply with the relevant EMC requirements. X-ray equipment and magnetic resonance

imaging (MRI) devices can emit high levels of electromagnetic radiation.

8 We recommend that exposure to ultrasound should be kept as low as reasonably achievable.

This is considered to be good practice and should be observed at all time.

9 Do not use the device with HF surgical equipmentand do not use it in an MRI environment.

10 The device is not protected against defibrillation.

11 SHOCK HAZARD - Do not attempt to replace batteriesor connect or disconnect a power cord

with wet hands.

12 The device should not be used adjacent to or stacked with other equipment and that if

adjacent or stacked use is necessary, the device should be observed to verify normal

operation in the configuration in which it will be used.

13 Please ensure the light of SpO2 sensor is fully covered by the finger pulp. Please check the

application site every 0.5 to 1 hour. If the skin quality changes, please change another site

14 The medical electrical equipment needs to be installed and put into service according to the

EMC Information provided in this user manual.

15 Portable and mobile RF communications equipment can affect medical electrical equipment;

refer to section Recommended Separation Distances.

16 Do not service or maintain the device or any accessory which is in use with a patient.

CAUTION

1 Refer servicing to qualified personnel.

2 Keep the device in a clean environment and avoid vibration during storage.

3 Do not sterilize the Doppler.

4 Only use SpO2 sensor approved by the manufacturer. Using other SpO2 sensors may

compromise device functionality.

5 Electromagnetic Interference - Ensure that the environment in which the device is operated is

not subject to any source of strong electromagnetic emissions, such as radio transmitters,

mobile telephones, etc.

6 The device and accessories are to be disposed of according to local regulations after their

useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling

or proper disposal. Batteries are hazardous waste. Refer to IEC61429 for standard disposal

when necessary.Do NOT dispose them together with house-hold garbage.

7 The loss of pulse signal may occur when the patient has poor peripheral perfusion, and the

screen will display "---". When there's measurement beyond range, invalid measurement or no

measurement value, it will display "---".

⚫ Introduction

Intended Use/Indications for Use

The SD2 detects fetal heart rate (FHR), maternal oxygen saturation (SpO2) and pulse rate (PR) for

pregnant women. The product is only intended for use in hospitals, clinics or at home by health care

professionals with relevant expertise and pregnant women who have been trained (by studying

instructional videos or product manuals) or have received professional guidance.

Features

You may not have all of these features, depending on the model purchased.

Model

SD2

SD2 Pro

SD2 Plus

Function

√

Curve Display

√

FHR

√

SpO2

√

Bluetooth +APP

√

Variable Frequency

√

AA Alkaline Batteries

Charging Function

NOTE: √ = Standard O = Optional

➢ At the end of the 20-week gestation, the uterus fundus is about 1 finger's breadth (about 1.5 cm)

SD2 Lite

SD2 Basic

below the navel.

➢ At the end of the 24-week gestation, the uterus fundus is about 1 finger's breadth (about 1.5 cm)

above the navel.

➢ At the end of the 28-week gestation, the uterus fundus is about 3 fingers' breadth (about 4.5 cm)

√

above the navel.

➢ At the end of the 32-week gestation, the uterus fundus is in the middle between the navel and

╳

√

the xiphisternum.

╳

➢ At the end of the 36-week gestation, the uterus fundus is about 2 fingers' breadth (about 3 cm)

╳

below the xiphisternum.

√

The clearest and loudest fetal heart sound is generally obtained when the Doppler is placed on the

fetus's back. Fetal movement is usually the movement of fetal limbs. So, if frequent fetal movement

occurs at the right side of the abdomen, the fetus's back is probablyat the left sideand vice versa.You can

find the fetus's back according to fetal movement's position.

If the fetus is in cephalic delivery position, the fetal heart is either on the right side or on the left side

below the navel; if the fetus is in breech delivery position, the fetal heart is either on the right side or on

SpO2 Wave Display Interface

the left side above the navel.

Steps to Find Fetal Heart:

Have the patient lie on back and relax >> confirm fetal position by hand >> apply coupling gel to the

Doppler>> place the Doppler on patient's abdomen and start looking for the fetal heart >> the fetal heart

is found when the Doppler gives out a continuing thumping sound "boom-boom-boom".

1 The Doppler's degree of protection against harmful ingress of water is IP22. Do not immerse it

in water.

2 The Doppler is delicate and sensitive. Please handle it with care and try to avoid dropping on to

the ground or any hard surfaces. Any damage caused by dropping is not covered by the

warranty.

3 Keep the coupling gel away from children. If swallowed, consult a physician at once.

Note:

1 The best quality of fetal heart signal is obtained only when the Doppler is placed in the best

detection position.

2 Do not place the Doppler near positions where placental sound or umbilical blood flow sound

is loud.

3 If the fetus is in the cephalic position and the mother is supine, the clearest heart sound will

normally be found on the midline below the navel. During detection, the pregnant woman's

prolonged lying in the supine position should be avoided to reduce the possibility of supine

hypotension. Putting a pillow or cushion under the patient's head or feet can be of help.

4 It is not possible to obtain accurate FHR unless a clear fetal heart signal is detected. If the

calculated FHR is not in accordance with the beat of the fetal heart sound, the fetal heart

sound auscultation result shall prevail.

5 Whether the fetal heart sound can be obtained or not is related to the skill and qualification of

the operator.

6 If the fetal heart sound cannot be found for a long time, it is necessary make use of other

equipment.

7 When applied to the patient, the Doppler may warm slightly (less than 2°C (35.6°F) above

ambient temperature). When NOT applied, the Doppler may slightly (less than 5°C (41°F)

above ambient temperature).

⚫ SOV Prompt

When detecting fetal heart rate, there are possibilities that maternal HR signal is mistaken for FHR signal.

The SOV function can reduce these possibilities.Detect FHR and PR at the same time. When FHR and

PR signals overlap, SD2 will issue a sound. At this time, examine the patient or reposition the probe until

Volume numeric is displayed in the center of the

screen, and ranges from level 0 to 7.

Displayed on the bottom left corner of the

screen and there are five degrees. When the

battery indicator is empty and keeps

flickering, it indicates that the battery level is

extremely low and battery needs to be

replaced or charged.

Displayed on the bottom right corner of the

screen

and

there

are

three

representing poor, acceptable and good

signal quality.

Touch the key to decrease volume.

Touch the key to increase volume.

Indicates the current ultrasound frequency. Touch the

volume increase and decrease touch keys simultaneously to

2MHz,

switch the frequency.

3MHz

2 MHz：used for more than 12-week gestation

3 MHz：used for more than 9-week gestation

Touch this key for a little while to switch it on or off;

Battery Capacity：500mAh~3000mAh

WARNING

before switching to display the test interface.

The coupling gel should not exceed this limit.

This area can be immerged in coupling gel

CAUTION

fetal heart signal is found.

⚫ SpO2 Detection

SpO2 Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in

the arterial blood. The SpO2 numeric shows the percentage of hemoglobin molecules which have

combined with oxygen molecules to form oxyhemoglobin. The SpO2/PLETH parameter can also provide

a pulse rate signal and a plethysmogram wave.

NOTE:

1 The device is calibrated to display functional oxygen saturation.

levels,

2 The monitor does not have specific SpO2 calibration baselines.

3 SpO2 waveform is not proportional to the pulse volume.

4 A Functional tester or simulator cannot be used to assess the SpO

be used to test the accuracy of a particular calibration curve duplicated by the device, and it

turns out the calibration curve meetsthe accuracy.

Inaccurate measurements can be caused but not limited by:

●

Incorrect device application

●

high levels of ambient light sources, such as surgical lights (especially those with a xenon light

source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight

●

failure to cover the sensor with fingerin high levels of ambient light conditions

●

dysfunctional hemoglobins

●

low peripheral perfusion

●

excessive or violent patient movement

●

venous pulsations

●

intravascular dyes, such as indocyanine green or methylene blue

●

externally applied coloring agents (nail polish, dye, pigmented cream)

●

defibrillation

●

placement of the device on an extremity with a blood pressure cuff, arterial catheter, or intravascular

line

●

electromagnetic interference

●

Low perfusion

Lossofpulse signal can occur for the following reasons:

●

a blood pressure cuff is inflated on the same extremity as the one with the device attached

●

there is arterial occlusion proximal to the device

●

low peripheral perfusion

⚫ Assessing the Validity of a SpO2 Reading

You can check the quality of the pleth wave and the stability of the SpO2 values to assess whether the

sensor functions properly and whether the SpO2 readings are valid. Always use these two indications

simultaneously to assess the validity of a SpO2 reading.

NOTE:

1 The SpO

accuracy has been validated in human studies against arterial blood sample

reference measured with a CO-oximeter. Pulse oximeter measurements are statistically

distributed, only about two-thirds of the measurements can be expected to fall within the

specified accuracy compared to CO-oximeter measurements. The volunteer population in the

studies composed of local healthy men and women from age 19 to 37, with variations of skin

pigmentations. The SpO

accuracy is as follows: ±2% for 90%-100% and ±4% for 70%-90%.

2 The pulse rate accuracy is obtained by comparison to the pulse rate generated with an arterial

oxygen simulator (also an electronic pulse simulator).

3 Generally, the quality of the SpO2 pleth wave reflects the quality of the light signals obtained by

the sensor. A wave of poor quality manifests a decline of the signal validity. On the other hand,

the stability of the SpO2 values also reflects the signal quality. Different from varying SpO2

readings caused by physiological factors, unstable SpO2 readings are resulted from the sensor's

receiving signals with interference. The problems mentioned above may be caused by patient

movement, wrong sensor placement or sensor malfunction. To obtain valid SpO2 readings, try to

limit patient movement, check the placement of the sensor, measure another site or replace the

sensor.

⚫ SpO2 Detection

1. Hold the device with one hand and press the thumb on the SpO2 sensor continuously.

2. Movement is not recommended during measurement.

3. When the signals are stable, read corresponding data from screen.

NOTE:Avoid external light sources such as radiated rays or ultrared rays.

After Detection

1) Switch off the Doppler.

2) Wipe the remaining gel off the patient and the probe with a clean soft cloth or tissue.

⚫ Mobile Application Software (APP)

SD2 can connect to mobile phones with its Bluetooth function (optional). The SD2 APP has both Android

and iOS versions.

iOS APP operating environment:

A) hardware environment

Processor: dual-core Apple A6

RAM: ≥2GB

B) software environment: iOS

13.5.1

and above

operating system

C)network environment: support Bluetooth

Scan either of the following QR codes to download the SD2APP, and install and run it as prompted.

Note:

1 Your mobile phone may prohibit the installation of

"applications from unknown sources". Enter Settings

to allow the installation first.

2 For normal functioning of the APP, please give the APP

function-related permissions.

3 For how to use the APP, read the instructions in the

iOS Version

Android Version

About sub-interface under the Settings interface of

the APP.

WARNING

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 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 guarantee 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.

Radiation Exposure Statement

This device complies with RF radiation exposure limits set forth for an uncontrolled environment.

This transmitter must not be co-located or operating in conjunction with any other antenna or

transmitter.

NOTE:

1.This equipment (SD2) 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.

2.Any changes or modifications to this unit not expressly approved by the party responsible for

compliance could void the user's authority to operate the equipment.

⚫ Maintenance and Cleaning

Maintenance

The overall check of the Doppler, including safety check and function check, should be performed by

qualified personnel every 12 months, and each time after service. And safety check must include current

leakage test and insulation test. Besides the above requirements, comply with local regulations on

maintenance and measurement.

The accuracy of FHR is determined by the Doppler and cannot be adjusted by user. If you have doubt

concerning the accuracy of FHR, verify it with other methods such as using a stethoscope, or contact

local distributor or the manufacturer for help.

The Doppler is frangible and must be handled with care.Wipe the remaining gel off the Dopplerafter each

use. These measures can help prolong the Doppler's life.

Replace the accessories such as the battery according to use. If any of the accessories are damaged,

refer to chapter Ordering Information for details and order new ones.

Please check the label for the date of manufacture, the service life is 5 years (The service life is limited to

the Doppler, not including the replaceable accessories. The only replaceable accessory of SD2 is battery.

The frequency of usage is 8 hours/day).

Cleaning

Before cleaning, switch off the Doppler.Clean the exterior surface of the Doppler with a soft,cleancloth

dampened withethanol (75%) or mild near neutral detergent thoroughly until no visible contaminants

remain. After cleaning, wipe off the cleaning solution with a fresh cloth or paper towel dampened with tap

water until no visible cleaning agent remains.Dry the monitor in a ventilated and cool place.

CAUTION

1 Do not use strong solvent, such as acetone.

2 Never use an abrasive such as steel wool or metal polish.

3 Do not remain any solution on the surface after cleaning.

Disinfection

Before disinfection, switch off the Doppler.

Wipe the exterior surface of the Doppler with a soft, clean cloth dampened with ethanol (75%) or mild

near neutral detergent.Wipe off the disinfectant solution with a dry cloth after disinfection if necessary.Dry

the Doppler for at least 30 minutes in a ventilated and cool place.

CAUTION

Do not immerse the Doppler into the disinfector or water.

⚫ Product Specifications

Product Information

Product Name

Ultrasonic Pocket Doppler

Model

SD2、 SD2 Basic、 SD2 Lite、 SD2 Plus、 SD2 Pro

Complied Standards

IEC 60601-1:2005/A1:2012, EN 60601-1:2006/A1:2013, IEC 60601-1-2:2014, IEC 60601-2-37:2015,

IEC 60601-1-11:2015, IEC 61266:1994

Classification

Anti-electric Shock Type:

Anti-electric Shock Degree:

Degree of Protection against Harmful Ingress of

Water:

Degree of Safety in Presenceof Flammable

Gases:

Working System:

EMC:

Physical Specifications

accuracy. However, it can

Android APP operating environment:

A) hardware environment

CPU: frequency≥1.0GHz

RAM: ≥4GB

B)software environment: Android 8.0 and above

operating system

C)network environment: support Bluetooth

Internally powered equipment

Type BF equipment

IP22 Protection against vertically falling water

drops when ENCLOSURE tilted up to 15°

Equipment not suitable for use in presence of

flammable gases

Continuous running equipment

CISPR 11 Group 1 Class B

EDAN SD2 USER MANUAL Pdf Download (2024)

References