SD5 and 6 User Manual Ver 1.3 July 2012

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.

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Table of Contents Chapter 1 Safety Guide ...1 1.1 Safety Precautions...1 1.2 Symbols...2 Chapter 2 Introduction...4 2.1 Intended Use...4 2.2 Major Parts ...4 2.2.1 Main Unit ...4 2.2.2 Probes...6 2.2.3 Control Keys ...7 2.2.4 Indicators...8 2.2.5 LCD...8 Chapter 3 Basic Operation...10 3.1 Opening Package and Checking...10 3.2 Using Batteries ...10 3.2.1 Fitting Main Unit Battery...10 3.2.2 Fitting Wireless Probe Battery ...12 3.2.3 Charging Main Unit Battery...13 3.2.4 Charging Wireless Probe Battery...13 3.2.5 Care of Batteries...14 3.3 Connecting the Power Cable...14 3.4 Using Wired Probe...14 3.4.1 Probe Socket...14 3.4.2 Connecting and Disconnecting a Wired Probe ...15 3.5 Switching On...15 3.6 Switching Off ...16 3.7 Using Earphone...17 3.8 Using Security Lock...17 3.9 Changing Doppler Settings ...19 3.9.1 Switching Backlight On and Off...19 3.9.2 Switching Key Sound On and Off ...19 3.9.3 Setting Auto-Shut-Off Time ...19 3.9.4 Choosing Language...19 3.9.5 Setting Date and Time...19 3.9.6 Setting Date Format ...20 3.10 Replacing Fuses ...20 Chapter 4 Examining...21 4.1 FHR Examining ...21

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4.2 Vascular Examining ...22 Chapter 5 Recording and Playing ...24 Chapter 6 Maintenance and Cleaning...25 6.1 Inspection ...25 6.2 Maintenance ...25 6.3 Cleaning ...26 6.4 Disinfection ...26 Chapter 7 Warranty and Service...27 7.1 Warranty...27 7.2 Contact information ...27 Chapter 8 Product Specifications ...28 8.1 Environmental Specifications ...28 8.2 Physical Specifications...28 8.3 Performance Specifications...29 8.4 Battery Specifications ...30 8.5 Low Output Summary Table...31 Appendix 1 Ordering Information ...32 Appendix 2 EMC Information – Guidance and Manufacture’s Declaration...33 A2.1 Electromagnetic Emissions- For all EQUIPMENT and SYSTEMS ...33 A2.2 Electromagnetic Immunity – for all EQUIPMENT and SYSTEMS ...34 A2.3 Electromagnetic Immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING ...35 A2.4 Recommended separation distances between portable and mobile RF communication equipment and the EQUIPMENT or SYSTEM- For EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING ...36 Appendix 3 Overall Sensitivity ...37 A3.1 Overall Sensitivity of SD5 (2MHz Wired Probe) ...37 A3.2 Overall Sensitivity of SD5 (3MHz Wired Probe) ...38 A3.3 Overall Sensitivity of SD6 (2MHz Wireless Probe) ...39 A3.4 Overall Sensitivity of SD6 (3MHz Wireless Probe) ...40

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SD5/SD6 Ultrasonic TableTop Doppler User Manual

Safety Guide

Chapter 1 Safety Guide NOTE: Familiarize yourself with this user manual before attempting to operate the Doppler. Follow the operation and maintenance instructions to ensure proper use of it.

1.1 Safety Precautions 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

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

2

SD5/SD6 Ultrasonic TableTop Doppler is a tool to aid healthcare professionals and should not be used in place of normal fetal monitoring.

3

This device is not intended for treatment.

4

Do not apply this device and other ultrasonic equipment simultaneously on a same patient, in case of possible hazard caused by leakage current superposition.

5

Do not touch accessible parts of non-medical electrical equipment and the patient simultaneously.

6

Do not apply this device simultaneously with other PATIENT-connected equipment, such as, a cardiac pacemaker or other electrical stimulators, on a same patient.

7

The device is not protected against defibrillation. Do not use it with HF surgical equipment. CAUTION

1

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

2

Refer servicing to qualified service personnel.

3

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

4

Keep the device clean. Avoid vibration.

5

Apply the SD5/SD6 in an environment with a temperature between +5 ºC (+41 ºF) and +40 ºC (+104 ºF).

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..

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SD5/SD6 Ultrasonic TableTop Doppler User Manual

Safety Guide

CAUTION 7

Check that the equipment does not have visible evidence of damage that may affect personnel’s safety or examining capability before use. If damage is detected, replacement is recommended.

8

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.

1.2 Symbols Headphones Equipotentiality Alternating Current Fuse “ON”/“OFF” for a part of equipment Menu Recording and play back Graphical recorder Move the cursor downwards Move the cursor upwards speaker Minus Plus Charge battery Push right

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SD5/SD6 Ultrasonic TableTop Doppler User Manual

Safety Guide

Caution. Refer to accompanying documents. Consult Instructions for Use Type B applied part. This symbol indicates the unit is internally powered equipment, and the degree of protection against electrical shock is type B. 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 regulations for separate collection after its useful life. IPX4

The device is protected against splashing water. Water splashed against the enclosure from any direction shall have no harmful effects. 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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SD5/SD6 Ultrasonic TableTop Doppler User Manual

Introduction

Chapter 2 Introduction 2.1 Intended Use The SD5 Ultrasonic TableTop Doppler (hereinafter called “SD5”) and SD6 Ultrasonic TableTop Doppler (hereinafter called “SD6”) 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 obstetrical 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 vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

2.2 Major Parts 2.2.1 Main Unit SD5: 1 2 3 4 5 1 Probe

5

6

2 Probe Cable 3 Main Unit

SD6:

1

4 LCD 5 Speakers 6 Probe Socket 3 4

5

7

5 Figure 2-1 Overview -4-

7 Infrared Receivers

SD5/SD6 Ultrasonic TableTop Doppler User Manual

Introduction

8 9 8 Probe Holder 9 Handle 10

10 Probe Sensor Socket 11 Main Unit Control Keys

11

Figure 2-2 Top View of the Main Unit 12 Main Unit Indicator 12

13

14

15

13 On/OFF Key

16

14 Setup Key / Confirm Key 15 Up Key / Record/Play Control Key 16 Down Key / Print Control Key

Figure 2-3 Main Unit Control Keys

20

17 Fuses 21

17

18 Power Socket 19 Equipotential Grounding Terminal 20 Main Unit Label

18

22

21 Security Slot 22 Earphone Socket

19 Figure 2-4 Back View of the Main Unit

23 Battery Compartment

23

Figure 2-5 Right View of the Main Unit -5-

SD5/SD6 Ultrasonic TableTop Doppler User Manual

Introduction

NOTE: The main unit is not waterproof. Do not immerse it in any type of liquid.

2.2.2 Probes Wireless Probe: 2

3

1

1 Acoustic Face 2 Probe Control Keys 3 Infrared Sender 4 Probe Socket

Wired Probe:

4

2

5 Probe Cable 5

1

Figure 2-6 Top View of the Probe

6

7

8

9

6 Volume Decreasing Key 7 Volume Increasing Key 8 ON/Off Key (only available on wireless probe) 9 Probe Indicator

Figure 2-7 Probe Control Keys 10

11

12

10 Probe Type Label 11 Probe Battery Compartment 12 Probe Charge Socket

Figure 2-8 Bottom View of the Probe

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SD5/SD6 Ultrasonic TableTop Doppler User Manual

Introduction

Description: The Doppler supports 2MHz, 3MHz, 4MHz, 5MHz and 8MHz probes supplied by the manufacturer. The probe nominal frequency is disclosed on the probe type label. Probes of SD5 are wired, while probes of SD6 are wireless. WARNING 1

Do not touch the charge sockets of the Wireless Doppler probe and the patient at the same time.

2

Do not immerse the probes or the probe cable in any liquid. CAUTION

Do not stretch the probe cable for more than three meters.

2.2.3 Control Keys Control keys are provided to switch on or off the device, perform the functions and change the settings. A beep sound will be heard when you press a key of the main unit. Or you can switch off the sound. Refer to section 3.9.2 Switching the Key Sound On and Off for operation procedures. (1) ON/OFF key Function: Switch on/off the main unit or the probe. (2) Up Key / Record/Play Control Key Function: Move the cursor upwards / to the previous item (in the setting mode). Recording and playing control (in the real-time examining mode). (3) Down Key / Print Control Key Function: Move the cursor downwards / to the next item (in the setting mode). Printing control (reserved). (4) Setup Key / Confirm Key Function: Enter setup menu (in the real-time examining mode). Confirm selection (in the setting mode). (5) Volume Control Keys Function: Decrease the FHR volume (

). Increase the FHR volume (

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SD5/SD6 Ultrasonic TableTop Doppler User Manual

Introduction

2.2.4 Indicators (1) Main unit indicator The indicator of the main unit indicates the connection status of the main unit and AC power: The indicator lights up in green – the AC power is connected. The indicator flashes in green – the main unit is charging the main unit battery. The indicator goes off – the AC power is not connected. (2) Probe indicator The indicator of the probe indicates the status of the probe: The indicator lights up in green – the probe is switched on. The indicator flashes in yellow when the volume control key is pressed – the volume has been decreased/increased to its minimum/maximum. The indicator lights up continuously in yellow – the probe battery is low. The indicator flashes in green – the probe battery is being charged.

2.2.5 LCD The Doppler has four modes: examining mode, recording mode, playing mode and setting mode. In the former three modes, the LCD displays as follows: 5

2

6 7

3

8

4

9

1

Item

Description The battery is installed and the battery energy is full.

1

2 3 4

Battery Indicator The main unit battery is low. The main unit battery is not installed. Recording Indicator: The Doppler is recording fetal heart sound. (Only in the recording mode) Playing Indicator: The Doppler is playing the recorded fetal heart sound. (Only in the playing mode) AC Indicator

AC power is connected.

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SD5/SD6 Ultrasonic TableTop Doppler User Manual Infrared Indicator (Only available with SD6) 5 Probe Indicator (Only available with SD5)

Introduction

Infrared signal is received. Infrared signal is not received, indicating that poor quality signal is received. The probe is well connected. The probe is not connected.

6, 7

Date and Time

8

Heart Beat Indicator: When fetal heart signal is received, the heart shape flashes to indicate the FHR refreshing frequency.

9

FHR numeric measurement value

In the setting mode, the LCD displays as the right figure shows. The rectangular mark that moves up and down is called the “cursor”. Press the Up key or the Down key to move it back or forth.

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SD5/SD6 Ultrasonic TableTop Doppler User Manual

Basic Operation

Chapter 3 Basic Operation 3.1 Opening Package and Checking Open the package; take out the Doppler and accessories carefully. Place them on a flat, clean surface. 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 Using Batteries CAUTION The fitting of the batteries should be carried out by the manufacturer authorized personnel. Do not remove them afterwards.

3.2.1 Fitting Main Unit Battery The main unit is powered either by alternating current or a Ni-MH battery. It is recommended to power the main unit solo by a battery during operation. Therefore, charge the battery fully before use to ensure enough power. Connecting to mains power supply will charge the battery no matter if the main unit is on or off. WARNING Switch off the Doppler and remove the power cord before fitting the main unit battery. To fit the battery for the main unit: 1 Follow the arrow direction to open the battery compartment cover. The battery connecting cable & connector and the metal insert show up.

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SD5/SD6 Ultrasonic TableTop Doppler User Manual

Basic Operation

Battery Connecting Cable & Connector

Metal Insert

2 Tilt the battery sideways and put its bottom left corner into the battery compartment from the left end of the compartment to the right. Make sure connector ① stays out of the compartment.

Battery Connector ①

Battery Connector ②

3 Keep pushing the battery into the compartment until the metal insert springs back to lock the battery.

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SD5/SD6 Ultrasonic TableTop Doppler User Manual

Basic Operation

4 Connect the two connectors (①&②) and then put them into the compartment.

5

Close the battery compartment cover.

3.2.2 Fitting Wireless Probe Battery The wireless probe is powered by a lithium battery. To fit the battery for the probe: 1

Remove the screw on the battery compartment cover with a screw driver and then take the cover away with your hand.

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SD5/SD6 Ultrasonic TableTop Doppler User Manual

Basic Operation

2

Fit the battery. Make sure the polarities correspond with the battery compartment diagram.

3

Close the battery compartment cover and fix it with the screw.

3.2.3 Charging Main Unit Battery Observe the battery indicator on the LCD, the panes in it indicate the main unit battery electric energy. They go off gradually with the consumption of the battery. When the battery indicator turns into “ ”, the battery power is low. You need to switch to outer AC power and charge the battery in time. To charge the main unit battery, you need to connect the Doppler to 100V-240V~ power supply. Connecting the main unit to power supply for approximately 3 hours will charge the battery fully, no matter if it is on or off. During this period, the main unit indicator flashes in green, and the panes in the battery indicator increase gradually. When the battery is fully charged, the indicator has four panes.

3.2.4 Charging Wireless Probe Battery When the wireless probe battery is low, the probe power indicator turns into yellow. You need to switch off the probe and charge the battery in time. To charge the probe battery, you need to place the probe in the probe holder. Connecting the main unit to alternating current is recommended. It takes 4 to 5 hours to fully charge the probe battery. During this period, both the main unit indicator and the probe indicator will flash in green. - 13 -

SD5/SD6 Ultrasonic TableTop Doppler User Manual

Basic Operation

3.2.5 Care of Batteries WARNING 1

Replacement of batteries shall be done at least 1.5 meters away from the patient.

2

Close the battery compartment before using the main unit or the probe.

3

Charge the battery with specified charger only.

4

Do not expose the batteries to high temperatures, heat them or dispose of them in fire.

5

Do not disassemble the batteries.

6

Short circuit should be avoided. CAUTION

1

Keep the batteries in a cool and dry environment. The environment temperature must not exceed the range of -20°C ~ +40°C (-4°F ~ +104°F).

2

If the Doppler is not used for an extended period, charge the batteries at least once a month.

3

The batteries must be properly disposed according to local regulations after their useful life.

3.3 Connecting the Power Cable Apply the power cable provided with the Doppler. Put the connector of the power cord to the power socket on the Doppler (figure 2-4). Put the plug of the power cord into a grounded 3-slot power output special for hospital usage. NOTE: Make sure the AC power supply of the Doppler complies with the following specification: 100V-240V~, 50Hz/60Hz. WARNING If the protective grounding (protective earth) system is doubtful, the power of the Doppler must be supplied only by inner power.

3.4 Using Wired Probe 3.4.1 Probe Socket SD5 adopts wired probes. The probe cable is a telephone cable with a standard RJ11 plug on each terminal. - 14 -

SD5/SD6 Ultrasonic TableTop Doppler User Manual

Basic Operation

RJ11 Interface: 1 2 3 4

Power VCC +5V GND Signal Wire Signal Wire

3.4.2 Connecting and Disconnecting a Wired Probe To connect the wired probe to the main unit, 1 Take out the probe cable from package. Insert one modular plug of the cable into the probe socket of the main unit. 2 Insert the other modular plug into the probe socket of the probe. Modular Plug

To disconnect the probe, press the housing of the modular plug and then pull it out.

Housing

3.5 Switching On WARNING Make sure all the metal parts are linked to the protective earth cord and the power cord is free of defect before switching on the main unit.

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SD5/SD6 Ultrasonic TableTop Doppler User Manual

Basic Operation

CAUTION To avoid unwanted noise, do not take out or place the probe when the main unit is on. Remember to take out the probe before switching on the main unit, and place the probe after switching off the main unit. To switch on the main unit, Pick up the probe and then press the ON/OFF key

on the main unit.

All the real-time examining menu elements light up in a few seconds. A start-up sound is heard. The Doppler performs a self test by displaying the FHR numerics in a fast speed. To switch on the wireless probe, Press the ON/OFF key

on the wireless probe. The probe indicator lights up in green.

NOTE: 1

The ON/OFF keys of the wireless probe and the main unit need to be pressed separately.

2

The wired probe is ready to use when the main unit is switched on.

3.6 Switching Off When the examination is finished, switch off the main unit, wipe the remaining gel off the probe with a clean soft cloth and then place the probe back into the holder. To switch off the main unit, perform any one of these operations: 1) Press the ON/OFF key

on the main unit.

2) Put the probe into the probe holder. 3) Auto shut off. If the main unit does not receive signal for a period of time, it will be switched off automatically. The auto-shut-off time is preset in the setup menu. Refer to section 3.9.3 Setting Auto-Shut-Off Time. To switch off the wireless probe, Press the ON/OFF key

on the wireless probe.

NOTE: It is recommended to switch off the probe first, and then put the probe into the probe holder.

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