SONOTRAX Ultrasonic Pocket Doppler User Manual Release 1.1

Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label 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.

II

Table of Contents Chapter 1 Safety Guide... 1 1.1 Intended Use... 1 1.2 Safety Precautions ... 1 1.3 Symbols... 4 Chapter 2 Doppler and Accessories... 5 2.1 Features ... 5 2.2 Main Unit ... 6 2.2.1 Appearance... 6 2.2.2 Display Panel... 7 2.2.3 Buttons ... 8 2.2.4 Socket ... 8 2.2.5 Probe Socket... 9 2.2.6 Batteries... 10 2.3 Probes ... 10 2.3.1 Waterproof Obstetrical Probes ... 10 2.3.2 Waterproof Vascular Probes ... 11 Chapter 3 Basic Operation ... 12 3.1 Opening the Package and Checking... 12 3.2 Installing/Replacing Battery... 12 3.3 Probe Operation... 14 3.4 Switching on... 16 3.5 Selecting Work Mode... 16 3.6 Enabling or Disabling Backlight ... 16 3.7 Switching Off ... 17 3.8 Replacing/Charging the Battery ... 17 3.8.1 Battery Energy Indication ... 17 3.8.2 Replacing Alkaline Batteries... 17 3.8.3 Charging the NI-MH Batteries... 18 3.8.4 Charging NI-MH Battery Pack ... 19 Chapter 4 Examining ... 20 4.1 FH Examining ... 20 4.2 FH Sound Recording and Playing... 21 4.3 FH Sound Recording by PC ... 22 4.3.1 Recording Sounds ... 22 4.3.2 Playing Sound Files... 24 4.3.3 Burning CD or Sending in Email ... 24 4.3.4 Record Troubleshooting... 24 4.4 Vascular Examining (Optional) ... 26 4.5 Completing Examining ... 28 III

Chapter 5 Product Specifications ... 29 Chapter 6 Maintenance ... 33 6.1 Maintenance ... 33 6.2 Cleaning ... 33 6.3 Disinfection of the Probe... 33 Chapter 7 Warranty and Service... 35 7.1 Warranty... 35 7.2 Contact information... 35 Appendix 1 Ordering Information ... 36 Appendix 2 EMC Information-Guidance and Manufacture’s Declaration ... 37 A2.1 Electromagnetic Emissions - for all Equipment and Systems... 37 A2.2 Electromagnetic Immunity - for all Equipment and Systems ... 37 A2.3 Electromagnetic Immunity - for all Equipment and Systems that are not Life-supporting... 38 A2.4 Recommended Separation Distances ... 39 Appendix 3 Overall Sensitivity... 40

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Safety Guide

Chapter 1 Safety Guide 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.

1.1 Intended Use The SONOTRAX Series Ultrasonic Pocket Dopplers (hereinafter called “the Doppler”) are intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz waterproof probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma. The 4 MHz, 5 MHz and/or 8 MHz waterproof vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

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

The Doppler is a tool to aid the healthcare professional and should not be used in place of normal fetal monitoring. It is not intended for treatment.

2

This device is not explosion-proof and can not be used in the presence of flammable anaesthetics.

3

Do not touch the signal input/output connector and the patient simultaneously.

4

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.

5

Only use the probes provided by the manufacturer.

6

Do not throw batteries in fire as this may cause explosion.

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Safety Guide

WARNING 7

Do not attempt to charge normal alkaline batteries. They may leak, catch fire or even explode.

8

Remove the batteries and store it at a cool and dry environment if the monitor is not used for a long time.

9

If the rechargeable batteries are stored alone and not used for a long time, we recommend that the batteries should be charged at least once every 6 months to prevent overdischarge.

10 The rechargeable NI-MH batteries and battery pack should be charged by using the dedicated adapters supplied by the manufacturer. 11 SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet hands. Make certain that your hands are clean and dry before touching a power cord. 12 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. 13 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC/EN 60601-1-1. Anybody who connects additional equipment to the signal input connector or signal output connector to configure a medical system must ensure that the system complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our technical service department or your local distributor. 14 Replacement or charging of the battery shall be done at least 1.5 meters away from patients.

CAUTION 1

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

2

Refer servicing to qualified personnel.

3

The main unit is designed for continuous operation and is ‘ordinary’. Do not immerse it in any liquid (i.e. not drip or splash-proof).

4

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

5

Do not disinfect or sterilize the Doppler.

6

Electromagnetic Interference - Ensure that the environment in which the device is operated is not subject to any source of strong electromagnetic interference, such as radio transmitters, mobile telephones, etc. -2-

SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Safety Guide

CAUTION 7

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.

8

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. ‹

Inspect the equipment for mechanical and functional damage.

‹

Inspect the safety relevant labels for legibility.

‹

Verify that the device functions properly as described in the instructions for use.

‹

Test the the pregnant woman’s leakage current according to IEC 60601-1: Limit: d.c 10 µA, a.c 100 µA.

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. 9

When the battery is charged, used or stored, keep it away from objects or materials with static electric charges.

10 If rechargeable batteries are used, charge them fully before initial use by using the method introduced in this manual. 11 Do not short-circuit the batteries or install the batteries reversely. 12 Store the batteries in a cool and dry environment. 13 Do not mix the batteries with metal objects to avoid short-circuit. 14 The device shall only be used when the battery cover is closed. 15 Batteries have life cycles. The alkaline batteries are intended to be used once. If the time that the Doppler using NI-MH battery becomes much shorter than usual, the battery life is at an end. Replace them with a new same one provided or recommended by the manufacturer. 16 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. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product.

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Safety Guide

1.3 Symbols The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices. The symbol indicates that the device should be sent to the special agencies according to local regulation for separate collection after its useful life. Consult Instructions for Use Attention. Direct current Type B applied part. Part Number Serial Number Date Of Manufacture

Manufacturer

Authorized Representative in the European Community

General symbol for recovery / recyclable Rx only (U.S.)

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

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Doppler and Accessories

Chapter 2 Doppler and Accessories 2.1 Features There are seven different models available: SONOTRAX Lite, SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II, SONOTRAX II Pro and SONOTRAX Vascular. SONOTRAX Lite and SONOTRAX Vascular are for simple auscultation (intermittent listening). SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II, and SONOTRAX II Pro not only detect fetal heart sound; they also display the fetal heart rate on a LCD screen. The features of the Dopplers are listed in the following chart: Function

Model

SONOTRAX Vascular

SONOTRAX Lite

SONOTRAX Basic

SONOTRAX Basic A

SONOTRAX Pro

SONOTRAX II

SONOTRAX II Pro

LCD Display

-

-

√

√

√

√

√

LCD Backlight

-

-

-

√

√

√

√

√

√

√

√

√

√

√

Probe Detecting

√

√

√

√

√

√

√

Probe Identifying

-

-

√

√

√

√

√

Audio Play

√

√

√

√

√

√

√

Attached Earphone

√

√

√

√

√

√

√

Volume Adjustable

√

√

√

√

√

√

√

Modes Switching

-

-

√

√

√

√

√

Audio Recording and Playing

-

-

-

-

√

-

√

√

√

√

√

√

-

-

*

*

*

*

*

-

-

Powered by NI-MH Battery Pack

-

-

-

-

-

√

√

Low Detecting indicating

√

√

√

√

√

√

√

Auto Shutdown

-

-

√

√

√

√

√

Vascular Examining

√

*

*

*

*

*

*

Mini USB Socket

Probe

Powered by Alkaline Batteries Powered by Rechargeable NI-MH Batteries

Battery &

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

√ = configured

- = not available

Doppler and Accessories

* = available

2.2 Main Unit NOTE: The pictures and interfaces in this manual are for reference only.

2.2.1 Appearance Take 2.0MHz obstetrical probe for example.

1 5 2

3

6

4 Figure 2-1 Front Panel

7

8

Figure 2-2 Rear Panel

9

10

Figure 2-3 Top Panel

11 Figure 2-4 Left Panel

1

Display Panel

2

POWER Button

3

Speaker

4

Probe Socket

5

Probe Holder

6

Battery Compartment

7

Charge Indicator/

8

Earphone Socket

9

Charge Socket

11

Buttons

Power Indicator 10

Volume Control

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Doppler and Accessories

2.2.2 Display Panel SONOTRAX Lite and SONOTRAX Vascular have a LED in the bottom left corner of its display panel area. When powered on, the LED turns green. If the LED flashes in green, it indicates that the probe is disconnected or poorly connected. If the LED flashes in orange, it indicates that the battery is too low to support working. Change for a new battery or charge the rechargeable battery in time. For SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II and SONOTRAX II Pro, the LCD is shown as follows: 1

5

2

3

6

4

7 Figure 2-5 LCD

Item

Screen Element

Description

1

FHR Refresh Frequency

2

Working Mode

3

Playing Indicator

4

Recording Indicator

5

Battery Indicator

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

6

Numeric FHR

7

Probe Type

Doppler and Accessories

2.2.3 Buttons At most there are three push buttons (MODE, START/STOP and REC/PLAY) and a volume control button on the main unit of the Doppler. Their primary functions are as follows: (1) MODE Button (Only for SONOTRAX Basic / SONOTRAX Basic A / SONOTRAX Pro / SONOTRAX II / SONOTRAX II Pro)

Function: Select the working mode.

(2) START/STOP Button (Only for SONOTRAX Basic / SONOTRAX Basic A / SONOTRAX Pro / SONOTRAX II / SONOTRAX II Pro)

Function: Start/ stop examining (Mode 3)/ setting (Mode 4 and Mode 5).

(3) REC/PLAY (Only for SONOTRAX Pro/ SONOTRAX II Pro)

Function: Start/ stop recording or playing fetal heart sound. (4) Volume Control Indicator Function: Adjust volume. Rotate the volume gear toward “+” to turn up the volume, while rotate it toward “-” to turn down the volume.

2.2.4 Socket The two sockets are located on the top panel of the Doppler. (1) Earphone socket : for outputting audio signals, the earphone or line-in cable connects to the Doppler via this socket.

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Doppler and Accessories

(2) Charge socket : for charging the NI-MH battery pack, the dedicated charger connects to the Doppler via this socket. (For SONOTRAX II and SONOTRAX II Pro only) NOTE: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC/EN 60601-1-1. Anybody who connects additional equipment to the signal input connector or signal output connector to configure a medical system must ensure that the system complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our technical service department or your local distributor.

2.2.5 Probe Socket The probe socket is as shown in figure 2-6.

Jack 1 2 3 4 5 6

Definition Power Supply Signal Probe Coding 1 Probe Coding 2 GND (Shell) GND

Figure 2-6 Probe socket

Connect the 2.0MHz/3.0MHz obstetrical probes or 4.0MHz/5.0MHz/8.0MHz vascular probes supplied by the manufacturer to the Doppler through the probe socket. CAUTION 1 Do not try to connect any other plug to the probe socket except the plug of the probes mentioned above. 2 Do not stretch the probe cable for more than two meters long.

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Doppler and Accessories

2.2.6 Batteries SONOTRAX Lite, SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro and SONOTRAX Vascular are powered either by two alkaline batteries or two rechargeable NI-MH batteries. SONOTRAX II and SONOTRAX II Pro are powered by a NI-MH battery pack supplied by the manufacturer.

Alkaline Battery

Rechargeable NI-MH Battery

NI-MH Battery Pack

Figure 2-7 Batteries

NOTE: The alkaline battery and rechargeable NI-MH battery can be replaced by those of identical specifications purchased locally. Alkaline battery: LR6, AA, 1.5V. Rechargeable NI-MH battery: Ni-MH, AA, 1.2V.

2.3 Probes 2.3.1 Waterproof Obstetrical Probes 2.0MHz/3.0MHz waterproof obstetrical probes can be connected to the main unit for fetal heart examining. The 2MHz obstetrical probe features in deep penetration and is designed for use during the third trimester pregnancy. The 3MHz obstetrical probe features in high sensitivity and is designed for use during the entire pregnancy.

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Figure 2-8

Doppler and Accessories

2.0/3.0MHz obstetrical probe

The main information on the probe is as follows: 2.0MHz/3.0MHz:means central frequency is 2.0MHz/3.0MHz. Waterproof: The probe is waterproof. IPX8: Water Ingress Protection Code. It indicates that this probe does not get soaked under water within 1 meter deep for five hours.

2.3.2 Waterproof Vascular Probes The 4.0MHz/5.0MHz/8.0MHz waterproof vascular probes can be connected to the main unit for artery and vein blood flow examining.

Figure 2-9

4.0/5.0/8.0MHz Vascular Probes

The main information on the probe is as follows: 4.0MHz/5.0MHz/8.0 MHz: means the central frequency is 4.0/5.0/8.0 MHz. Waterproof: The probe is waterproof. IPX8: Water Ingress Protection Code. It indicates that this probe does not get soaked under water within 1 meter deep for five hours.

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Examining

Chapter 3 Basic Operation NOTE: To ensure that the Doppler works properly, please read this chapter and Chapter 1 Safety Guide before operation; follow the steps when connecting all the components.

3.1 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.

3.2 Installing/Replacing Battery NOTE: The battery pack of SONOTRAX II and SONOTRAX II Pro is fixed in the battery compartment cover. Start from step 3 when installing it. 1) Open the battery compartment. Turn the Doppler upside down. Hold the main unit with one hand; press the thumb of the other hand on the cover notch and push it upward and forward. The compartment cover is open.

Figure 3-1 Opening battery compartment - 12 -

SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Examining

2) Install the battery. Put the alkaline batteries or NI-MH batteries into the battery compartment cover. CAUTION The direction of the batteries should comply with the polar mark on the cover. Reversed connection is forbidden.

Figure 3-2 Putting batteries into the compartment cover

3) Close the compartment. Put the batter compartment cover back into the compartment, push it forward and downward until it clicks closed.

Figure 3-3 Close the battery compartment

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Examining

CAUTION 1 If the Doppler is not used for an extended period, take the alkaline/NI-MH batteries out and store them in a cool and dry environment. 2 Do not remove the NI-MH battery pack frequently after initial installation. 3 If the Doppler is not used for an extended period, charge the NI-MH batteries or the NI-MH battery pack at least every three months.

3.3 Probe Operation (1) Taking out the probe Hold the main unit with one hand. Pinch the probe and pull it outwards using mild force.

Figure 3-4 Taking out the probe

(2) Placing the probe Hold the main unit with one hand. Pinch the probe and align it with the probe holder. Push the probe inwards using mild force until it clicks in position.

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SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Examining

Figure 3-5 Placing the probe

CAUTION Do not take out or place the probe when the Doppler is on. Remember to take out the probe before switching on the Doppler, and place the probe after switching off the Doppler. (3) Replacing the Probe Remove the old probe: Switch off the Doppler; hold the main unit with one hand and pinch the jacket of the mini USB socket. Lift the jacket up slightly and pull it out with mild force; take out the probe. CAUTION Do not pull the probe cable directly.

Figure 3-6 Removing the probe - 15 -

SONOTRAX Series Ultrasonic Pocket Doppler User Manual

Examining

Replace it with a new probe: Put the USB socket of new probe into the probe interface of the Doppler. NOTE: Place the temporarily unused probe carefully and avoid falling off, splash or stress, etc. When the Doppler is not used for a long time, it’s recommended to connect the probe to the Doppler and keep them safely in the package.

3.4 Switching on Press the POWER button on the front panel to switch on the Doppler. If the probe is not connected or poorly connected, the LCD display a flashing “--- MHz” sign. You should reconnect the probe properly. When the probe is well connected, the LCD stops flashing and shows the probe frequency in the bottom right corner.

3.5 Selecting Work Mode The Doppler has four work modes. They are: Mode 1: Real-time FHR Display Mode Mode 2: Averaged FHR Display Mode Mode 3: Manual Counting Mode Mode 4: Backlight Brightness Setting Mode button on the left panel, the doppler work mode switches Press the among these modes, and the work mode is shown in the top left corner of LCD. When the doppler is swiched on, it enters mode 1 automatically.

3.6 Enabling or Disabling Backlight SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II and SONOTRAX II Pro have backlight. You can enable or disable it.

Keep pressing the button until the working mode on LCD displays 4. Press the button. The backlight is enabled when the LCD reads “ON”, and it is disabled when the LCD reads “OFF”. The setting in this mode is saved automatically after the mode is changed or normal power-off.

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