EDAN INSTRUMENTS SD1MEDAN User Manual

Download

SD1 Ultrasonic Pocket Doppler User Manual

 FHR monitoring and display

 FH signal intensity

indicator

 FH sound

 FH icon

 Switching off when no signal received

for 2 Min

 Battery indicator  Sound volume adjustment

 Low battery warning

 Bluetooth connection (Optional)

 Sound volume levels

Item

Description

Fetal heart icon

Indicates fetal heart beat and flickers to the

fetal heart beat.

Fetal heart signal intensity indicator

This indicator displays on the left side of the screen and has three status: empty, half empty and full, which respectively represents low, medium and high fetal heart signal intensity.

FHR numeric

Displays fetal heart rate within the range from 50 bpm to 240 bpm. When fetal heart rate is out of the range, it displays ―---‖.

Sound volume numeric

Sound volume numeric is displayed in the center of the screen, the same area as the FHR numeric. When you adjust sound volume, the sound volume numeric will display for 0.5 second before switching back to display FHR numeric. Sound volume ranges from level 0 to 7.

Battery indicator

Battery indicatordisplays on the right side of the screen. There are 5 battery levels, represented by 0 to 4 panes in the icon. When battery is empty, battery empty icon

will be displayed and flickering, and the battery needs replacing.

Sound volume increase touch key

Touch the keyfor a little while to increase

sound volume.

Sound volume decrease touch key

Touch the key for a little while to decrease

sound volume.

On/Off touch key

When the Doppler is off, touch this key for a little while to switch it on; When the Doppler is on, touch this key for a little while to switch it off.

Ultrasonic Transducer Head

LCD Screen

Touch Keys

Loudspeaker

Screw

Battery Compartment Cover

About this Manual

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:SD1 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

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.

1 It is to be used by health care professionals on the order of a physician. 2 The Doppler is a tool to aid the healthcare professional in hospitals,

clinics or at home and should not be used in place of normal fetal monitoring. It is not intended for treatment or use during labor and delivery.

3 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.

4 This device is not explosion-proof and cannot be used in the presence

of flammable anesthetics.

5 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.

6 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.

7 Do not use the device with HF surgical equipmentand do not use it in

an MRI environment.

CAUTION

WARNING

8 The device is not protected against defibrillation. 9 SHOCK HAZARD - Do not attempt to replace batteries with wet

hands.

10 Do not connect any equipment or accessories that are not approved by

the manufacturer or that are not IEC 60601-1 approved to the device. The operation or use of non-approved equipment or accessories with the device is not tested or supported, and device operation and safety are not guaranteed.

11 Using accessories other than those specified by the manufacturer may

result in increased electromagnetic emissions or decreased electromagnetic immunity of the device.

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 The medical electrical equipment needs to be installed and put into

service according to the EMC Information provided in this user manual.

14 Portable and mobile RF communications equipment can affect medical

electrical equipment; refer to section Recommended Separation Distances.

15 Do not service or maintain the device or any accessory which is in use

with a patient.

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 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.

5 Prior to examination using the Doppler, check for visible damages of

the main unit and the probe that may endanger the patient/operator or machine performance. If the damage is found, replace them with good ones at once.

6 The following safety checks should be performed once every two years

or as specified in the institution‘s test and inspection protocol by a

qualified person who has adequate training, knowledge, and practical experience to perform these tests.

WARNING

CAUTION

 Inspect the equipment for mechanical and functional damage.  Inspect the safety relevant labels for legibility.  Inspect the equipment for mechanical and functional damage.  Inspect the safety relevant labels for legibility.

The leakage current should never exceed the limit. The data should be recorded in an equipment log. If the device is not functioning properly or fails any of the above tests, the device has to be repaired.

7 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. Do NOT dispose them together with house-hold garbage. .

 Introduction

Intended Use/Indications for Use

The SD1 is a pocket Doppler device used for detecting the fetal heartbeat from the 10th week of gestation. It is intended to be used by medical professionals only.

Features

Appearance（Above pictures are just for reference）

LCD Display& Touch Keys

Battery

SD1 is powered by two AA alkaline batteries. Battery specification: LR6, AA, 1.5 V;

Note:

You can use AA alkaline batteries of the same specification purchased locally.

 Basic Operation

NOTE: To ensure that the Doppler works properly, please read this chapter and ChapterSafety Precautions before operation; follow the steps when connecting all the components.

Opening the Package and Checking

Open the package; take out the Doppler and accessories carefully. Keep the package for possible future transportation or storage. Check the components according to the packing list.

 Check for any mechanical damage.  Check all the cables and accessories.

If there is any problem, contact us or your local distributor immediately.

Installing the Battery

a) Unscrew the screw with a cross screwdriver and remove the battery

compartment cover.

b) Insert the battery into the compartment carefully. Ensure its anode and

cathode terminals are aligned with the anode and cathode marks on the compartment.

c) Install the compartment cover and secure it with the screw.

Removing/ Replacing the Battery

a) Unscrew the screw with a cross screwdriver and remove the battery

compartment cover.

b) Take out the used battery. You can also replace it with a new one.

Ensure the new battery‘s terminals are placed in the right direction as

indicated by the anode and cathode marks.

c) Install the compartment cover and secure it with the screw.

1 Turn off the Doppler before removing or replacing the battery.

iOS APP operating environment:

Android APP operating environment:

A) hardware environment

Processor: dual-core Apple A6

CPU: frequency≥1.0GHz

RAM: ≥1GB

B) software environment: iOS

8.0 and above operating system

B)software environment: Android

4.3 and above operating system

C)network environment: support Bluetooth

TBC

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 About sub-interface under the Settings interface of the APP.

Checking Item

Method

Visual Check

Inspect the Doppler for any damage.

Functional Check

Check if the Doppler can be switched on and off normally (see Switching On and Switching Off)When the Doppler is switched on, check if the display panel works as described in LCD Display&Touch Keys; touch the ultrasonic transducer head gently with your hand and check if the Doppler gives out sound normally.

Product Name

Ultrasonic Pocket Doppler

Model

SD1

IEC 60601-1:2005/A1:2012, EN 60601-1:2006/A1:2013, IEC 60601-1-2:2014, IEC 60601-2-37:2015,IEC 61266:1994

Anti-electric Shock Type:

Internally powered equipment Anti-electric Shock Degree:

Type BF equipment

Degree of Protection against Harmful Ingress of Water:

IP22. Do not immerse it in water. Degree of Safety in Presenceof

Equipment not suitable for use in

The coupling gel should not exceed

this limit.

This area can be immerged in coupling gel

2 Replace alkaline batteries with those of identical specifications

provided by the manufacturer or purchased locally.SeeChapterProduct Specificationsfor details about battery specifications.

3 If the batteries have been inserted incorrectly, the Doppler will not

function or it will be damaged.

4 Do not disassemble or short-circuit batteries. 5 Do not recharge batteries. 6 Do not dispose of batteries in fire or water. 7 Do not allow metal objects to contact the battery terminals. 8 Do not mix with used or other battery type (such as alkaline with

carbon zinc).

9 Do not solder the batteries directly. If soldering or welding

connection to the battery is required, consult our engineer for proper methods.

10 Do not over-discharge batteries. 11 To install or remove batteries, follow the equipment manufacturer‘s

instructions.

12 Keep battery away from small children. If swallowed, consult a

physician at once.

13 Store the battery in cool, dry place before use.Do not keep batteries

at temperature of 45°C or above, or at humidity of 75% or above.

14 Dispose the battery according to the local regulations. Refer to

IEC61429 for standard disposal when necessary.

Switching On

Touch the On/Off touch key for about 1second when the Doppler is off, and the Doppler will display the switching on interface before switching to display the test interface .

Switching Off

Touch the On/Off touch key for about 1second when the Doppler is on, and the Doppler will be switched off. If the Doppler is not in operation or no signal is received for 2 minutes, the Doppler will switch off automatically.

WARNING

 FHR Monitoring

Before applying the Doppler to inspect FHR, you should always check whether the Doppler is in good condition and whether there is evident damage that might a ffect patient‘s safety and the device‘s function.If evident damage is found, stop using it at once and replace it with a good one.

Procedures to Monitor FHR:

a) Have the patient lie on her back. b) Apply appropriate

amount of coupling gel to the ultrasonic transducer head of the Doppler and switch on the Doppler.

c) Palpate the patient‘s

abdomen gently to

confirm the fetus‘s

position.

d) Place the Doppler on

the patient‘s abdomen,

and move it around the fetus‘s position or tilt it until a clear and rhythmic heart sound is heard and FHR numeric is stably displayed.

Note:

1 Do not mistake the maternal heart rate for fetal heart rate.Do not

mistake the maternal heart rate for fetal heart rate. The fetal pulse should be different from the maternal pulse, which can be measured at the wrist or neck.

2 Do not wear gloves to touch the keys. If there's water and coupling gel

on the fingers, please clean them first or the touching effect will be influenced.

How to Find the Best FH Signal:

1) The easiest way: take the position the doctor last monitored for FHR

as a reference and move the Doppler around the position slowly until the best FH signal is found.

2) The fetal heart position may change as the fetus moves inside the

uterus. You can confirm the fetal position first according to the position of the uterus fundus in different gestational weeks. 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 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 t he 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 on the best monitoring 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 monitoring, t he 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 pa tient‘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 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).

After Monitoring

1) Switch off the Doppler.

2) Wipe the remaining gel off the patient and the probe with a clean soft

cloth or tissue.

CAUTION

 Mobile Application Software (APP)

SD1 can connect to mobile phones with its Bluetooth function (optional). The SD1 APP has both Android and iOS versions.

How to use SD1 Medical APP

1.Download and install software Scan either of the following QR codes to download the SD1Medical APP, and install and run it as prompted.

2.Activate the device Open the APP and go to Settings>Activation and input SD1 activation code (14 numbers after 01).

3.Pair device Open Bluetooth function of the mobile to automatically pair the SD1.

4.Start detection Put the coupling gel on SD1 and position the probe to the optimal place of maternity's abdomen. And click the "start" key. After pressing start,

confirm that the data on the APP and the SD1 probe match. As with any Bluetooth communication, it is important to make sure the connection is not compromised.

5.Adjust the fetal heart beat sound volume

When using mobile phone to play the fetal heart beat sound, you can adjust the volume with the volume keys of the mobile phone. When using SD1 to play the heart beat sound, touch ‗volume+‘ or ‗volume -‘ to adjust the volume.

6.Finish the monitoring

When the monitoring is finished, click ‗Stop‘ touch key and the detection

data will be saved automatically. Note:Please make sure your mobile phone has enough battery power,and avoid killing the process directly or switching to other applications during the fetal heart monitoring.

7.Real time detection mode and DEMO mode

We provide DEMO mode for users' reference. You can turn on DEMO key in Setup and enter fetal heart monitoring interface to watch the DEMO. The word ‗DEMO‘ is displayed in the interface to distinguish from real time detection.

SD1 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.

NOTE:

1.This equipment (SD1) has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.

WARNING

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 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 correctthe 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.

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

Before each use, check if the equipment has visible evidence of damage

that may affect the patient and the operator‘s safety or the Doppler‘s

functioning. If the damage is evident, contact the manufacturer for service or replace it. 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 SD1 is battery. The frequency of usage is 8 hours/day).

Cleaning

Before cleaning, switch off the Doppler. Keep the exterior surface of the device clean and free of dust and dirt. Clean the exterior surface of the Doppler with a dry, soft cloth. If necessary, clean it using a soft cloth dampened with mild near neutral detergent, ethanol (75%) or isopropanol (70%), and then wipe it dry with a dry cloth immediately.

1 Do not use strong solvent, such as acetone. 2 Never use an abrasive such as steel wool or metal polish. 3 The Doppler‘s degree of protection against harmful ingress of water is

IP22. Do not immerse it in water.

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

Disinfection

In normal use theDoppler does not need disinfection. In case of being soiled, clean the main unit case and then disinfect it by wiping it with a soft cloth dampened with ethanol (75%) or isopropanol (70%). Then wipe it dry with a dry cloth.

Do not immerse the Doppler into the disinfector.

Sterilization

Do not sterilize the Doppler.

NOTE:

After cleaning or disinfection, check if the Doppler functions well. If any problem is detected, please contact the manufacturer for service before reusing it.

CAUTION

 Product Specifications

Product Information

Complied Standards

Classification

Flammable Gases:

presence of flammable gases

Working System:

Continuous running equipment

EMC:

CISPR 11 Group 1 Class B

Physical Specifications

Size:

Length*Width* Height: (48±2) mm× (39±2) mm× (147±3) mm

Weight:

< 180g

LCD: Size:

(24±2) mm× (13±2) mm

Display:

◆FHR

◆Battery level

◆Signal intensity

◆Sound volume

level

◆FH icon

Coupling Gel:

pH: 5.5~8.0 Acoustic Impedance: 1.5x106 Pa.s/m ~1.7x106Pa.s/m (35°C/95ºF )

Working:

Temperature:+5°C ~ +40°C ( +41ºF ~ +104ºF) Humidity:15% RH ~ 95% RH(non-condensing) Atmospheric Pressure:70kPa ~ 106 kPa

Transport and Storage:

Temperature:-25°C ~ +70°C (-13ºF ~ +158ºF) Humidity:15% RH ~ 95% RH (non-condensing) Atmospheric Pressure:70 kPa ~106 kPa

FHR (Essential Performance):

FHR Measuring Range: 50 bpm ~ 240 bpm Accuracy: ±2 bpm Note: FHR measurement result may not be accurate if the equipment is measuring beyond its measuring range.

FHR Resolution:

1bpm

Audio Output:

Output Power: 2w Background noise: <45dBA

Auto Power-off:

Power off when the Doppler receives no signal or operation for 2 minutes.

Bluetooth:

TransmissionRange (Without Obstacles) :>5m (Indoor range depends on the building‘s structure and material.)

Ultrasound:

Nominal Frequency: 3MHz

Working Frequency: 3MHz

p_<1 MPa

Iob<10 mW/cm2

Ispta<100 mW/cm2

Isata<10 mW/cm2

Isppa.3<190 W/cm2

Ispta.3<94 mW/cm2

Effective Radiating Area: 490mm2 ± 15%

Working Mode: pulse wave

Specification:

Two AA 1.5V alkaline batteries (AA, LR6, 1.5V)

Working Duration:

◆≥6h

FCC ID

SMQSD1MEDAN

Modulation:

GFSK π /4-DQPSK 8DPSK

Frequency:

2400-2483.5MHz

Tolerance Frequency:

≤ 20ppm

RF output power:

≤ 20dBm (EIRP)

Occupied Channel Bandwidth:

≤ 2MHz

Transmitter Unwanted Emissions:

≤﹣30dBm

Model (MHz)

spta.3

(mW/cm2)

Type

Value

sppa.3

(W/cm2)

SD1

CD3.0

5.69

TIS

0.05

0.01

0.02

TIB

0.01

Parts

Part Number

Main Unit

SD1

Doppler(Non-Bluetooth

version)

02.06.262535

SD1 Doppler(Bluetooth

version)

02.06.262639

Accessories

AA Alkaline Battery

01.21.064086

Normal Carry Case

01.56.465616

Coupling Gel

01.57.078170

Index label

TIS

TIB

TI C

At Surf ace

Bel ow Surf ace

At surf ace

Bel ow Surf ace

Maximum index value

0.0 1

0.05

0.01

N/A Index component value

N/A

0.05

0.01

Acoust ic Param eters

pr.αat

zMI (MPa)

0.0 2

P (mW)

7.35

N/A P1x1 (mW)

N/A

N/A zs(cm)

3.50 zb(cm)

3.70

zMI(cm)

3.7 0

zPII.α

(cm).α

3.7 0

fawf (MHz)

3.0 0

3.00

N/ A

Other inform ation

prr (Hz) 5000

srr(Hz)

N/ A

npps 1

Ipa.α at zPII.α

(W/cm2)

0.0 2

Ispta.α at zPII.α or zSII.α(m

W/cm2)

5.6 9

Ispta at zPII or zSII (mW/cm2 )

12. 26

pr. at zPII (MPa)

0.0 4

Operating control conditions

Fixed

Acoustic Output

ISPTA.3 (mW/cm^

ISPPA.3 (W/cm^2 )

Global Maximum Value

0.01

5.69

0.02

Associate d Acoustic Paramete r

Pr.3 (MPa)

0.02

W0 (mW)

7.35

8.97

fc (MHz)

3.00

Zsp (cm)

3.70

Beam dimension s

X-6 (cm)

2.50

Y-6 (cm)

2.50

PD (usec)

72.2 5

72.25

PRF (Hz)

5000

EBD Az.

(cm)

2.50

Ele. (cm)

2.50

Operating Control Condition s

Fixed

IEC60601-2-37 Standard Parameters

Paramete r

Note

Parameter Note

r.α

Attenuated Peak-rare-factiona l Acoustic Pressure

awf

Center Frequency, Acoustic Working Frequency

Peak-rare-factiona l Acoustic Pressure

X -12dB Output

Beam Dimensions

Environment

Performance Specifications

Battery Specifications

Bluetooth Specifications

Low OutputSummary Table

(For systems whose global maximum valuedoes not exceed 1.0) System: SD1 Ultrasonic Pocket Doppler

 Ordering Information

CAUTION

Only the parts supplied by the manufacturershould be used with the Doppler.

 Ultrasound Intensity and Safety

Ultrasound in Medicine

The use of diagnostic ultrasound has proved to be a valuable tool in medical practice. Given its known benefits for non-invasive investigations and medical diagnosis, including investigation of the human fetus, the question of clinical safety with regards to ultrasound intensity arises. There is no easy answer to the question of safety surrounding the use of diagnostic ultrasound equipment. Application of the ALARA (As Low As Reasonably Achievable) principle serves as a rule-of-thumb that will help you to get reasonable results with the lowest possible ultrasonic output.

The American Institute of Ultrasound in Medicine (AIUM) states that given its track record of over 25 years of use and no confirmed biological effects on patients or instrument operators, the benefits of the prudent use of diagnostic ultrasound clearly outweigh any risks.

Ultrasound Safety and the ALARA Principle

Ultrasound waves dissipate energy in the form of heat and can therefore cause tissue warming. Although this effect is extremely low with Doppler, it is important to know how to control and limit patient exposure. Major governing bodies in ultrasound have issued statements to the effect that there are no known adverse effects from the use of diagnostic ultrasound,however, exposure levels should always be limited to As Low As Reasonably Achievable (the ALARA principle).

Explanation of MI/TI MI (Mechanical Index)

Cavitations will be generated when ultrasound wave passes through and contacts tissues, resulting in instantaneous local overheating. This phenomenon is determined by acoustic pressure, spectrum, focus, transmission mode, and factors such as states and properties of the tissue and boundary. This mechanical bioeffect is a threshold phenomenon that occurs when a certain level of ultrasound output is exceeded. The threshold is related to the type of tissue. Although no confirmed adverse mechanical effects on patients or mammals caused by exposure at intensities typical of present diagnostic ultrasound instruments have ever been reported, the threshold for cavitation is still undetermined. Generally speaking, the higher the acoustic pressure, the greater the potential for mechanical bioeffects; the lower the acoustic frequency, the greater the potential for mechanical bioeffects. The AIUM and NEMA formulate mechanical index (MI) in order to indicate the potential for mechanical effects. The MI is defined as the ratio of the peak-rarefactional acoustic pressure (should be calculated by tissue acoustic attenuation coefficient 0.3 dB/cm/MHz) to the acoustic frequency.

MI = Pr, α

fawf ×CMI

CMI = 1 (MPa / MHz )

TI (Thermal Index)

Heating of tissues is caused by absorption of ultrasound when the ultrasound energy is applied. The temperature rise is determined by the acoustic intensity, exposed area and thermo physical properties of the tissue. In order to indicate the potential for temperature rise caused by thermal effects, the AIUM and NEMA formulate thermal index (TI). It is defined as the ratio of the total acoustic power to the acoustic power required to raise the tissue temperature by 1ºC (1.8°F). According to different thermo physical properties of the tissue, TI is divided into three kinds: TIS, TIB and TIC. TIS (Soft Tissue Thermal Index): It provides an estimate of potential temperature rise in soft or similar tissues. TIB (Bone Thermal Index): It provides an estimate of potential temperature rise when the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone. TIC (Cranial Bone Thermal Index): It provides an estimate of potential temperature rise in the cranial bones or superficial bones.

Measurement Uncertainties

The uncertainties in the measurements were predominantly systematic in origin; the random uncertainties were negligible in comparison. The overall systematic uncertainties were determined as follows:

1. Hydrophone Sensitivity: ± 12percent for intensity, ± 6 percent for pressure. Based on the hydrophone calibration report by ONDA. The uncertainty was determined within ±1 dB in frequency range 1-15 MHz.

2. Digitizer: ±0.3 percent for intensity. ± 0.15 percent for pressure.

Based on the stated accuracy of the 8-bit resolution of the Agilent DSO6012 Digital Oscilloscope and the signal-to-noise ratio of the measurement.

3. Temperature:±2.4 percent for intensity uncertainty, ±1.2 percent for

pressure uncertainty.

Based on the temperature variation of the water bath of ± 1ºC (1.8°F).

4. Spatial Averaging: ± 3.5 percent for intensity, ± 1.75percent for

pressure.

5. Non-linear Distortion: N/A.

No effects of nonlinear propagation were observed.

Since all the above error sources are independent, they may be added on an RMS basis, giving a total uncertainty of ± 12.73 percent for all intensity values reported, ± 6.37 percent for all the pressure values,,± 12.6 percent for the Mechanical Index, uncertainty of ±12.73% percent for power,±0.15 percent for center frequency, ±6.87%for the MI.

Prudent Use Statement

Although no confirmed bioeffects on patients caused by exposure from present diagnostic ultrasound equipment have ever been reported, the potential exists that such bioeffects may be identified in the future. Therefore, the ultrasound should be used prudently. High levels of acoustic output and long exposure time should be avoided while acquiring necessary clinical information.

Reference for Acoustic Output and Safety

1. ―Bioeffects and Safety of Diagnostic Ultrasound‖ issued by AIUM in

1993

2. ―Medical Ultrasound Safety‖ issued by AIUM in 1994

3. "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3" issued by AIUM/NEMA in 2004

4. "Standard for real-time display of thermal and mechanical acoustic

output indices on diagnostic ultrasound equipment, Revision 2" issued by AIUM/NEMA in 2004

5. "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in 2008.

6. ―Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment" issued by IEC in 2007.

Acoustic Output Reporting Table for Track 1 Acoustic output

reporting table for IEC60601-2-37(IEC60601-2-37, Edition 2.1, 2015-0,

table 201.103)

Transducer Model: SD1, Operating Mode: PW mode

Acoustic Output Reporting Table for Track1(Non-autoscanning

Transducer Model: SD1 ,Operating Model: PW

Mode)

Standard Parameter Equal Contrast List

Output Power

Depth for Soft Tissue Thermal Index

Pulse Duration

Pα(Zs)

Attenuated Output Power

prr

Pulse Repetition Frequency (Pulse Repetition Rate)

ta.α(Zs

)

Attenuated Temporal-average Intensity

deq

Equivalent Beam Diameter

zbp

Break-point Depth

pi.α

at max

Attenuated Pulse-averag e Intensity at the point of Maximum MI

Depth for Bone Thermal Index

aprt

-12dB Output Beam Area

pi.α

Attenuated Pulse-intensity Integral

Mechanical Index

Ipi

Pulse-intensity Integral

TIS

Soft Tissue Thermal Index

deq(Zb)

Equivalent Beam Diameter at the point of Zsp

TIB

Bone Thermal Index

TIC

Cranial-bone Thermal Index

 EMC Information

Guidance and manufacturer’s declaration – electromagnetic

emission

The SD1 Ultrasonic Pocket Doppler is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Emission test

Compliance

Electromagnetic

environment - guidance

RF emissions CISPR 11

Group 1

The SD1Ultrasonic Pocket Doppler 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 emission CISPR 11

Class B

The SD1 Ultrasonic Pocket Doppler 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/EN61000-3-2

Not

applicable

Voltage fluctuations /flicker emissions IEC/EN61000-3-3

Not

applicable

Guidance and manufacture’s de cl aration–electromagnetic immunity

The SD1 Ultrasonic Pocket Doppler is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Immunity test

IEC 60601 test

level

Complia

nce level

Electromagnetic

environment-gui

dance

Electrostatic discharge (ESD) IEC 61000-4-2

8kV contact

15kV air

8kV

contact

15kV

air

Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.

Electrical Fast Transient/Burs t IEC/EN610004-4

±2kV

forpowersupply

lines

±1kV

forinput/outputl

ines

Not applicabl e

Not applicable

Surge IEC/EN610004-5

± 1 kV line(s)

toline(s)

± 2 kV line(s)

to earth

Not applicabl e

Not applicable

Voltage dips, short interruptions, and voltage variations on power supply input lines IEC/EN610004-11

<5%UT(>95%

dip inUT)

for 0.5cycle

40%UT(60%di

p in UT)

for5 cycles

70%UT(30%di

p in UT)

for25 cycles

<5%UT(>95%

dip inUT)

for 5s

Not applicabl e

Not applicable

Power frequency (50Hz/60Hz) magnetic field IEC61000-4-8

30 A/m

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

Guidance and manufacture’s de cl aration – electromagnetic immunity

The SD1 Ultrasonic Pocket Doppler is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Immunity

test

IEC

60601

test level

Complianc

e level

Electromagnetic

environment-guidanc

Conducted RF IEC61000-46

Radiated RF IEC61000-43

3 V

rms

150 kHz ~ 80 MHz 6Vrmsc)i n ISM bands between 0,15 MHz

and80 MHz

10V/m 80 MHz ~

2.7 GHz

3 V

rms

150 kHz to 80 MHz 6Vrmsc)in ISM bands between 0,15 MHz and 80 MHz

10 V/m 80 MHz to

2.7 GHz

Portable and mobile RF communications equipment should be used no closer to any part of the SD1

Ultrasonic Pocket Doppler, including

cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

Pd 2.1

150 kHz

to 80 MHz

Pd 2.1

MHz to 800 MHz

Pd 3.2

800 MHz to 2.7 GHz d=6 /E at RF wireless communications equipment bands (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 SD1 Ultrasonic Pocket Doppler, including cables specified by the manufacturer). 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:

NOTE1:At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2: 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 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 SD1 Ultrasonic Pocket Doppler is used exceeds the applicable RF compliance level above, the SD1Ultrasonic Pocket Doppler should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SD1 Ultrasonic Pocket Doppler.

Over the frequency range 150 kHz to 80 MHz, field strengths should be

less than 3 V/m.

The ISM (industrial, scientific and medical) bands between 0,15 MHz

and 80 MHz are 6,765 MHz to6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz,21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.

Test Freq uenc

(MH

Bran

d a)

(MH

Service

Modu lation

Maxi mum Powe

r(W)

Dist ance

(m)

IMM UNIT

TEST

LEVE

(V/m)

385

380-

390

TETRA

400

Pulse

modul ation

18Hz

1.8

0.3

450

430-

470

GMRS

460,

FRS 460

FM C)

±5

kHz

deviati

1kHz

sine

0.3

710

704-

787

LTE Brand 13, 17

Pulse modul ation

217

0.2

0.3

745

780 810

800-

960

GSM

800/900,

TETRA 800,iDE

N 820, CDMA

850, LTE

Band 5

Pulse modul ation

18 Hz

0.3

870

930

1720

1700

-199 0

GSM 1800;

CDMA

1900; GSM 1900;

DECT;

LTE

Band 1,

4,25;U

MTS

Pulse modul ation

217

0.3

1845

1970

2450

2400

-257 0

Bluetoot

WLAN,

802.11 b/g/n, RFID 2450,

LTE

Brand 7

Pulse modul ation

217

0.3

5240

5100

-580

WLAN

802.11

a/n

Pulse modul ationb)

217

0.2

0.3

5500

5785

Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM maybe reduce to 1m. The 1 m test distance is permitted by IEC

61000-4-3.

a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50% duty cycle square wave signal. c) As an alternative FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case

Recommended separation distances between portable

and mobile RF communications equipment and the SD1

Ultrasonic Pocket Doppler

The SD1 Ultrasonic Pocket Doppleris intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of theSD1 Ultrasonic Pocket Doppler can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SD1 Ultrasonic Pocket Doppleras recommended below, according to the maximum output power of the communications equipment.

Rated

maximum

output

power of

transmitter

(W)

Separation distance according to frequency of

transmitter (m)

150 kHz to

80 MHz

Pd 2.1

80 MHz to

800 MHz

Pd 2.1

800 MHz to

2.7GHz

Pd 3.2

0.01

0.12

0.23

0.1

0.38

0.73 1 1.2

1.2

2.3

3.8

7.3

100

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.

Electromagnetic Emissions

Electromagnetic Immunity

Table-Test specifications for ENCLOSURE PORT IMMUNITY to RF

wireless communications equipment

Recommended Separation Distances

 Overall Sensitivity

D d A

∑Ba BB

1.58

3MHz

5 0

77.1 4

7 5

5.412

7 5

80 4 0

6.011

104

69.1 8

9 0

6.012

205

83 4 2

5.912

2.38

3MHz

5 0

77.1 3

6 9

5.512

7 5

77.1 1

5 5

6.412

104

68.1 3

6 5

6.011

205

78 4 3

5.113

Doppler Frequency (Hz)

505

Velocity of

N ot e

D: Diameter ofTarget Reflector(mm)

A: Attenuation A(dB))

S：Overall Sensitivity (S=A+B+C)dB

d: Distance (d)(mm)

VS: Signal RMS (mV)

C:Signal to Noise Ratio (dB)

   



 





 





...

log20

smrV

B:Two-wayAttenuat ion(dB) B=∑Ba+Bw

Vn: Noise RMS (mV)

Problem

Possible Cause

Solution

Fail to power on, or shut down shortly after switching on

Battery level is very low.

Replace the battery.

Battery is not installed properly.

Re-install the battery.

Fail to switch on the Doppler as instructed.

Touch the On/Off touch key for a while to power on the Doppler.

The Doppler has malfunctions.

Contact service personnel.

Loudspeaker does not work. Sound volume has been turned down to the lowest level.

Adjust sound volume to appropriate level.

If the Doppler is configured with Bluetooth, fetal heart sound can be played by mobile phone.

Set to play fetal heart sound by mobile phone or the Doppler on the APP.

The Doppler has malfunctions.

Contact service personnel.

FHR cannot be displayed stably.

There is strong interference source such as high frequency machines and mobile phones nearby.

Use the Doppler away from strong interference sources.

The fetal heart position has changed because of fetal movement.

Relocate the Doppler to the best fetal heart rate monitoring position.

Friction between the

Doppler and patient‘s

abdomen causes false displaying.

Find the best fetal heart rate monitoring position.

Sensitivity is low and noise is too much.

There is strong interference source such as high frequency machines and mobile phones nearby.

Use the Doppler away from strong interference sources.

The Doppler is not applied with coupling gel.

Apply coupling gel to the Doppler.

The Doppler is not placed at the best monitoring position.

Relocate the Doppler to the best fetal heart rate monitoring position.

The Doppler has malfunctions.

Contact service personnel.

Doppler cannot be connected to mobile phone.

The Bluetooth of mobile is not open.

Open the Bluetooth of mobile.

The Doppler used is not configured with Bluetooth function.

Use the Doppler with Bluetooth function.

The Bluetooth function of Doppler has malfunctions.

Use the FHR and sound detected and displayed on the SD1 itself, and contact service personnel.

N o.

Symbol Definitio n No.

Symbol

Definition

CE marking

Authorized Representativ e in the European Community

Disposal method

General symbol for recovery/recy clable

Operatin g instructio ns

Refer to User Manual (Background: Blue; Symbol: White)

Caution

MR Unsafe–Keep away from magnetic resonance imaging (MRI) equipment

Type BF applied

part

Non-ionizing electromagnet ic radiation

Part Number

Dustproof and waterproof degree is IP22(rainproo f)

Serial Number (Start with H on battery compart ment cover)

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

Date of Manufact ure

FCC ID:

SMQSD1ME

DAN

Federal Communicati ons Commission: FCC ID: SMQSD1ME DAN

Manufact urer

 Troubleshooting

repaired.

Contact Information

If you have any question about maintenance, technical specifications or malfunctions of devices, contact your local distributor. Alternatively, you can send an email to EDAN service department at: support@edan.com.cn.

EDAN INSTRUMENTS, INC.

Address: #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, PingshanDistric, 518122 Shenzhen, P.R. China Email: info@edan.com.cn Tel: +86-755-2689 8326 Fax: +86-755-2689 8330 www.edan.com.cn

 Definition of Symbols

 Warranty and Service

Warranty

EDAN warrants that EDAN‘s products meet the labeled specifications of

the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: A. damage caused by mishandling during shipping. B. subsequent damage caused by improper use or maintenance. C. damage caused by alteration or repair by anyone not authorized by

EDAN.

D. damage caused by accidents. E. replacement or removal of serial number label and manufacture label. If a product covered by this warranty is determined to be defective because of defective materials, components, or workmanship, and the warranty claim is made within the warranty period, EDAN will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide a substitute product for use when the defective product is being

EDAN INSTRUMENTS SD1MEDAN User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual