EDAN INSTRUMENTS SD6PEDAN Ultrasonic TableTop Doppler Probe User Manual

EDAN INSTRUMENTS, INC. Ultrasonic TableTop Doppler Probe

User manual

I About this Manual P/N: 01.54.456994 MPN: 01.54.456994011 Release Date: Oct. 2015 © Copyright EDAN INSTRUMENTS, INC. 2015. All rights reserved. Statement This manual will 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) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are 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 intellectual properties 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. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable. 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
II 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.
III Table of Contents Chapter 1 Safety Guide ................................................................................................................. 1 1.1 Intended Use/Indications for Use ........................................................................................ 1 1.2 Safety Precautions ............................................................................................................... 1 1.3 Symbols ............................................................................................................................... 4 Chapter 2 Introduction .................................................................................................................. 6 2.1 Main Unit ............................................................................................................................ 6 2.2 Probes .................................................................................................................................. 8 2.3 Control Keys ....................................................................................................................... 9 2.4 Indicators ........................................................................................................................... 10 2.5 LCD ................................................................................................................................... 11 Chapter 3 Basic Operation .......................................................................................................... 13 3.1 Opening Package and Checking........................................................................................ 13 3.2 Using Batteries .................................................................................................................. 13 3.2.1 Fitting Main Unit Battery ........................................................................................ 13 3.2.2 Fitting Wireless Probe Battery ................................................................................ 15 3.2.3 Charging Main Unit Battery.................................................................................... 16 3.2.4 Charging Wireless Probe Battery ............................................................................ 16 3.2.5 Care of Batteries ...................................................................................................... 17 3.3 Connecting the Power Cable ............................................................................................. 17 3.4 Using Wired Probe ............................................................................................................ 17 3.4.1 Probe Socket ........................................................................................................... 17 3.4.2 Connecting and Disconnecting a Wired Probe ....................................................... 18 3.5 Switching On ..................................................................................................................... 18 3.6 Switching Off .................................................................................................................... 19 3.7 Using Earphone ................................................................................................................. 20 3.8 Changing Doppler Settings ............................................................................................... 20 3.8.1 Switching Backlight On and Off ............................................................................. 20 3.8.2 Switching Key Sound On and Off .......................................................................... 20 3.8.3 Setting Auto-Shut-Off Time ................................................................................... 21 3.8.4 Choosing Language ................................................................................................. 21 3.8.5 Setting Date and Time ............................................................................................. 21 3.8.6 Setting Date Format ................................................................................................ 21 3.9 Replacing Fuses ................................................................................................................ 22 Chapter 4 FHR Examining ......................................................................................................... 23 Chapter 5 Recording and Playing .............................................................................................. 25 Chapter 6 Maintenance and Cleaning ....................................................................................... 26
IV 6.1 Inspection .......................................................................................................................... 26 6.2 Maintenance ...................................................................................................................... 26 6.3 Cleaning ............................................................................................................................ 27 6.4 Disinfection ....................................................................................................................... 27 6.5 Sterilization ....................................................................................................................... 28 Chapter 7 Warranty and Service ............................................................................................... 29 7.1 Warranty ............................................................................................................................ 29 7.2 Contact information .......................................................................................................... 29 Chapter 8 Product Specifications ............................................................................................... 30 8.1 Environmental Specifications ........................................................................................... 30 8.2 Physical Specifications ..................................................................................................... 30 8.3 Performance Specifications ............................................................................................... 31 8.4 Battery Specifications ....................................................................................................... 32 8.5 Low Output Summary Table ............................................................................................. 33 Appendix 1 Ordering Information ............................................................................................. 34 Appendix 2 EMC Information .................................................................................................... 35 A2.1 Electromagnetic Emissions ............................................................................................ 35 A2.2 Electromagnetic Immunity ............................................................................................. 36 A2.3 Electromagnetic Immunity ............................................................................................. 37 A2.4 Recommended Separation Distances ............................................................................. 38 Appendix 3 Ultrasound Intensity and Safety ............................................................................ 39 A3.1 Ultrasound in Medicine .................................................................................................. 39 A3.2 Ultrasound Safety and the ALARA Principle ................................................................ 39 A3.3 Explanation of MI/TI ..................................................................................................... 39 A3.3.1 MI (Mechanical Index) ........................................................................................ 39 A3.3.2 TI (Thermal Index) ............................................................................................... 40 A3.3.3 Measurement Uncertainties .................................................................................. 40 A3.4 Prudent Use Statement ................................................................................................... 40 A3.5 References for Acoustic Output and Safety ................................................................... 41 A3.6 Probe Acoustic Output Parameters List ......................................................................... 41 Appendix 4 Overall Sensitivity ................................................................................................... 43 A4.1 Overall Sensitivity of SD5 (2MHz Wired Probe) .......................................................... 43 A4.2 Overall Sensitivity of SD5 (3MHz Wired Probe) .......................................................... 44 A4.3 Overall Sensitivity of SD6 (2MHz Wireless Probe) ...................................................... 45 A4.4 Overall Sensitivity of SD6 (3MHz Wireless Probe) ...................................................... 46
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide - 1 - 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 Intended Use/Indications for 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. 1.2 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 SD5/SD6 Ultrasonic TableTop Doppler is a tool to aid healthcare professionals 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 SHOCK HAZARD – In order to protect the patient and the operator, the device case should be grounded. The power receptacle must be a three-slot grounded outlet. 4 SHOCK HAZARD – Do not attempt to connect or disconnect a power cord with wet hands. Make sure that your hands are clean and dry before touching a power cord. 5 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. 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. If in doubt, consult our technical service department or your local distributor. 6 Exposure to ultrasound should be kept as low as reasonably achievable.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide - 2 - WARNING 7 Do not touch the signal input/output connector and the patient simultaneously. 8 Do not apply this device and other ultrasonic equipment simultaneously on the same patient, in case of possible hazard caused by leakage current superposition. 9 Do not apply this device simultaneously with other PATIENT-connected equipment, such as, a cardiac pacemaker or other electrical stimulators, on the same patient. 10 The device is not protected against defibrillation. 11 Do not use the device with HF surgical equipment. 12 Only use the probes provided by the manufacturer. 13 Before using the battery, make sure to read the user manual and safety precautions thoroughly. 14 Do not heat or throw the battery into fire as this may cause explosion. 15 Do not solder the leading wire and the battery terminal directly. 16 Do not destroy the battery: Do not pierce the battery with a sharp object such as a needle; do not hit with a hammer, step on or throw or drop to cause strong shock; do not disassemble or modify the battery. 17 The battery should be charged, used or stored away from the static electricity. 18 Do not mix the battery with metal objects to avoid short-circuit. 19 The battery should be charged at least once a month to prevent overdischarge. 20 Replacement or charging of the battery shall be done at least 1.5 meters away from patients. 21 The device shall only be used when the battery cover is closed. 22 If the device is not used for a long time, please remove the battery and store it as required. 23 If the liquid leak from the battery spills onto your skin or clothes, wash well with fresh water immediately. 24 If the liquid leak from the battery gets into eyes, do not rub the eyes. Wash them well with clean water and see a doctor immediately. 25 Stop using the battery if abnormal heat, odor, discoloration, deformation or any other abnormal condition is detected during use, charge, or storage. Please dispose it according to the local regulations. 26 Do not immerse, throw, or wet the battery in water/seawater. 27 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide - 3 - WARNING 28 Using accessories other than those specified by the manufacturer may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device. 29 The appliance coupler or mains plug is used as isolation means from supply mains. Position the device in a location where the operator can easily access the disconnection device. 30 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. 31 The medical electrical equipment needs to be installed and put into service according to the EMC Information provided in this user manual. 32 Portable and mobile RF communications equipment can affect medical electrical equipment, refer to section A2.4 Recommended Separation Distances. 33 Do not service or maintain the device or any accessory which is in use with a patient. 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 Do not sterilize the Doppler with autoclave or gas. 6 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. 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide - 4 - 1.3 Symbols No. Symbol Definition 1 Headphones 2 Equipotential grounding 3 Alternating Current 4 Fuse 5 ON/OFF switch 6 Menu 7 Recording and play-back 8 Print control 9 Move the cursor downwards 10 Move the cursor upwards 11 Speaker 12 Decrease 13 Increase 14 Charge battery 15 Push right 16 Caution 17 Operating instructions
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide - 5 - 18 TYPE BF APPLIED PART 19 CE marking 20 Disposal method 21 IPX4 The device is protected against splashing water. Water splashed against the enclosure from any direction shall have no harmful effects. 22 Part Number 23 SERIAL NUMBER 24 Date of manufacture 25 MANUFACTURER 26 AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 27 General symbol for recovery/recyclable 28 Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. 29 Refer to User Manual (Background: Blue; Symbol: White) 30 Non-ionizing electromagnetic radiation 31* FCC ID: SMQSD6PEDAN Federal Communications Commission: FCC ID: SMQSD6PEDAN 32* FCC ID: SMQSD6MEDAN Federal Communications Commission: FCC ID: SMQSD6MEDAN NOTE: 1 The user manual is printed in black and white. 2 * Applicable to SD6 only.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction - 6 - Chapter 2 Introduction NOTE: The pictures and interfaces in this manual are for reference only. 2.1 Main Unit SD5: SD6: Figure 2-1 Overview Figure 2-2 Top View of the Main Unit 1 Probe 2 Probe Cable 3 Main Unit 4 LCD 5 Speakers 6 Probe Socket 8 9 10 7 Probe Holder 8 Handle 9 Probe Sensor Socket 10 Main Unit Control Keys 1 2 3 4 5 6 5 3 4 5 5 7 1
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction - 7 - WARNING Please do not touch the probe sensor socket and the patient simultaneously. Figure 2-3 Main Unit Control Keys Figure 2-4 Back View of the Main Unit Figure 2-5 Right View of the Main Unit NOTE: The main unit is not waterproof. Do not immerse it in any type of liquid. 18 17 16 20 19 16 Fuses 17 Power Socket 18 Equipotential Grounding Terminal 19 Main Unit Label 20 Earphone Socket 21 Battery Compartment 21 11 12 13 14 15 11 Main Unit Indicator 12 On/OFF Key 13 Setup Key / Confirm Key 14 Up Key / Record/Play Control Key 15 Down Key / Print Control Key
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction - 8 - 2.2 Probes WARNING Do not touch the charge sockets of the Doppler probe and the patient simultaneously. CAUTION 1. Do not immerse the probe (and the probe cable) in any liquid. 2. Do not stretch the probe cable for more than three meters. Wireless Probe: Wired Probe: Figure 2-6 Top View of the Probe Figure 2-7 Probe Control Keys Figure 2-8 Bottom View of the Probe 1 Acoustic Face 2 Probe Control Keys 3 Probe Socket 4 Probe Cable 2 1 5 6 7 8 9 Probe Type Label 10 Probe Battery Compartment 11 Probe Charge Socket 9 10 11 43 1 2 5 Volume Decreasing Key 6 Volume Increasing Key 7 Power Key (only available on wireless probe) 8 Probe Indicator
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction - 9 - Description: The Doppler supports 2 MHz and 3 MHz 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 SD6 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 (SD6) has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no 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. 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. 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 3.8.2 Switching the Key Sound On and Off for operation procedures. (1) Power Key
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction - 10 - Function: Switch on/off the main unit or switch on the probe. Note that if the probe fails to connect the main unit in two minutes, it will power off automatically. (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 ( ). 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. For SD6, the indicator lights up continuously in yellow – the probe battery is low; the indicator flashes in green – the probe battery is being charged.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction - 11 - 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: Item Description 1 Battery Indicator The battery is installed and the battery energy is full. The main unit battery is low. The main unit battery is not installed. 2 Recording Indicator: The Doppler is recording fetal heart sound. (Only in the recording mode) 3 Playing Indicator: The Doppler is playing the recorded fetal heart sound. (Only in the playing mode) 4 AC Indicator AC power is connected. 5 Bluetooth Indicator (Only available with SD6) The wireless probe is switched on and its communication with the main unit is normal. The wireless probe is switched off or its communication with the main unit failed. Probe Indicator (Only available with SD5) The wired probe is well connected. The wired probe is not connected. 6 Fetal heart signal intensity indicator 7 FHR numeric measurement value 8, 9 Date and Time 10 Heart Beat Indicator: When fetal heart signal is received, the heart shape flashes to indicate the FHR refreshing frequency. 11 Volume Indicator 1 2 3 8 9 10 11 5 4 6 7
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction - 12 - 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. The LCD displays the battery charging icon when the main unit is shut off and charging. During the charging process, the battery charging icon changes as the battery level increases.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation - 13 - 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's authorized personnel. 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation - 14 - 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. 3 Keep pushing the battery into the compartment until the metal insert springs back to lock the battery. Battery Connecting Cable & Connector Metal Insert Battery Connector ① Battery Connector ②
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation - 15 - 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation - 16 - 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 100 V-240 V~ power supply. Connecting the main unit to the AC power supply will charge the battery, no matter if it is on or off. If the main unit is in the stand-by or switch off state, it takes no more than 5 hours to fully charge the main unit battery. 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. Then connect the main unit to the AC power supply. If the probe is in the switch off state, it takes no more than 5 hours to fully charge the probe battery. During this period, both the main unit indicator and the probe indicator will flash in green.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation - 17 - 3.2.5 Care of Batteries WARNING 1 Replacement or charging 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 Do not expose the batteries to high temperature, heat them or dispose of them in fire. 4 Do not disassemble the batteries. 5 Short circuit should be avoided. CAUTION 1 If the Doppler is not used for an extended period, remove the batteries and 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: 100 V-240 V~, 50 Hz/60 Hz. WARNING If the protective grounding (protective earth) system is doubtful, 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation - 18 - RJ11 Interface: 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. To disconnect the probe, press the housing of the modular plug and then pull it out. 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 damage before switching on the main unit. Modular Plug Housing 1 Power 2 GND 3 Signal Wire 4 Signal Wire
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation - 19 - 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 (if the key sound is enabled) 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 Power key on the wireless probe. The probe indicator lights up in green. NOTE: 1 For SD6, the Power keys of the wireless probe and the main unit need to be pressed separately. After they are switched on, they will be connected with each other automatically, and the LCD will display to indicate normal connection. If you touch the acoustic faceplate of the probe gently with your hand, the Doppler will give out sound. 2 For SD6, docking the probe when the main unit is powered on and is in normal connection with the probe, the probe will turn off automatically and begin to charge. If you take up the probe within 3 hours, it will power on automatically and be ready for use. 3 For SD5, 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 3.8.3 Setting Auto-Shut-Off Time.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation - 20 - To switch off the wireless probe: NOTE: 1 If the probe is not to be used over a relatively long period of time, It is recommended to switch off the main unit first, and then put the probe into the probe holder. 2 For SD6, if you switch off the main unit when it is in normal connection with the probe, the probe will also be switched off. 3.7 Using Earphone In a noisy environment, you are advised to use an earphone to hear fetal heart sound. Insert the earphone plug into earphone socket on the back of the main unit (figure 2-4). The speakers will be muted when the earphone is connected. WARNING Turn down the volume before using earphone to your ears. CAUTION 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. 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. If in doubt, consult our technical service department or your local distributor. 3.8 Changing Doppler Settings 3.8.1 Switching Backlight On and Off 1 Press the Setup key for about 2 seconds to open setup menu. 2 Press the Setup key when the cursor stays at Backlight. 3 Press the Up/Down key to toggle between ON and OFF. 4 Press the Setup key. 3.8.2 Switching Key Sound On and Off 1 Press the Setup key for about 2 seconds to open setup menu. 2 Press the Up/Down key to move the cursor to Key Sound, press the Setup key. 3 Press the Up/Down key to toggle between ON and OFF.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation - 21 - 4 Press the Setup key. 3.8.3 Setting Auto-Shut-Off Time The Auto-Shut-Off feature facilitates the economical use of the Doppler. The main unit will switch off automatically after no signal is received and no operation is performed for 1 minute， 3 minutes or infinite time. 1 Press the Setup key for about 2 seconds to open setup menu. 2 Press the Up/Down key to move the cursor to Auto Shut Off, press the Setup key. 3 Press the Up/Down key to move the cursor among options. 4 Press the Setup key. 3.8.4 Choosing Language 1 Press the Setup key for about 2 seconds to open setup menu. 2 Press the Up/Down key to move the cursor to Language, press the Setup key. 3 Press the Up/Down key to select the required language. 4 Press the Setup key. 3.8.5 Setting Date and Time 1 Press the Setup key for about 2 seconds to open setup menu. 2 Press the Up/Down key to move the cursor to Real Time Clock, press the Setup key. 3 Press the Setup key when the cursor stays at Hour. 4 Press the Up/Down key to choose a number from 00 to 23 and then press the Setup key to confirm the choice. 5 In the same way, choose the Minute from 00 to 59. Choose the Year, Month and Day. 6 Move the cursor to EXIT and then press the Setup key. 3.8.6 Setting Date Format You can choose to switch the date on or off. When it is on, the date format has three options: DD/MM/YYYY, MM/DD/YYYY and YYYY/MM/DD. To switch the date on and off or change date format: 1 Press the Setup key for about 2 seconds to open setup menu. 2 Press the Up/Down key to move the cursor to Date Format, press the Setup key. 3 Press the Up/Down key to toggle between ON and OFF. If you choose ON, the cursor moves to the date format. Select a format. 4 Press the Setup key. NOTE: If no operation is performed in 30 seconds, the device will exit from the setup menu. The
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation - 22 - setting changes will not be effective. 3.9 Replacing Fuses WARNING Switch off the main unit and unplug it before replacing the fuses. Two fuses are located on the rear panel of the device, their specifications are: Size: Ф5 mm*20 mm; Model: T400mAH250V. When any one of the fuses is blown, perform the following steps to replace it: 1. Using a flat-head screw driver, push the fuse in for about one millimeter and then rotate it anticlockwise. 2. Remove the old fuse and replace it with a new fuse that is supplied by the manufacturer or of the same specifications. 3. Push the new fuse into the socket for about one millimeter and then rotate it clockwise back into position.
SD5/SD6 Ultrasonic TableTop Doppler User Manual FHR Examining - 23 - Chapter 4 FHR Examining WARNING 1 Always check if the main unit and the probe are in good condition prior to use. 2 To avoid inaccurate diagnosis: (a) relocate the probe for the best FHR signal as the fetal position changes; (b) when intrauterine fetal death is doubted by using this examination method, try to verify it with other methods. CAUTION Handle the probe with care. Do not drop it on hard surfaces. The 2 MHz and 3 MHz obstetrical probes are designed for FHR examining. The 2 MHz probe is optimized for deep penetration and is widely used in the third trimester pregnancy. The 3 MHz probe is a general purpose probe. It has better resolution and wider detection range than the 2 MHz probe, therefore is optimized for early fetal heart detection. Follow these procedures to perform FHR examining: 1 Feel the position of the fetus by hand to find the best position to detect the fetal heart. 2 Switch on the Doppler and the probe. 3 Apply a small amount of coupling gel to the acoustic face of probe; place the probe face at the best position for detecting fetal heart. Angle the probe to obtain an optimum audio signal. Adjust the volume if required. When an audible fetal heart signal is detected, a clear fetal heart sound will be heard from the speakers/earphone, and numeric FHR value will be displayed on the LCD. NOTE: 1 The best quality records will only be obtained if the probe is placed in the optimum position. 2 Positions with strong placental sounds or umbilical blood flow sound should be avoided. 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 umbilicus. During examining, the pregnant woman’s prolonged lying in the supine position should be avoided owing to the possibility of supine hypotension. Sitting up or lateral positions are preferable and may be more comfortable. 4 It is not possible to obtain accurate FHR unless an audible 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual FHR Examining - 24 - 5 When applied to the patient, the ultrasound transducer may warm slightly (less than 8°C (14.4°F) above ambient temperature). When NOT applied, the ultrasound transducer may reach the highest temperature of 8°C (14.4ºF). 6 Maternal heart will be detected if the probe is strongly placed on maternal vessel. 7 For SD6, the effective transmission distance between the main unit and the wireless probe is 5 meters. It is recommended that they are positioned within this distance in photopic vision.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Recording and Playing - 25 - Chapter 5 Recording and Playing The built-in recorder of the Doppler allows recording and playing fetal heart sound of 240 seconds (at most). To record fetal heart sound: Press and hold the Record/Play control key for two seconds. The character REC on the LCD lights up. Recording starts. Press the Record/Play control key again to stop recording and return to the real-time examining mode. To play the fetal heart sound: Press the Record/Play control key in the real-time examining mode. The character PLA on the LCD lights up. The Doppler plays the recorded fetal heart sound. NOTE: Observe the LCD, pay attention not to mistake the recorded fetal heart sound for the real-time sound.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Maintenance and Cleaning - 26 - Chapter 6 Maintenance and Cleaning 6.1 Inspection (1) Visual Inspection Prior to using the device every time, do the following inspections:  Check the device and accessories to see if there is any visible evidence of damage that may affect patient safety.  Check the power socket and power cables.  Check if the device functions properly to make sure it is in good condition. If any damage is detected, stop using the device on the patient. Replace the damage part(s) or contact the manufacturer for service before reusing it. (2) Routine Inspection The overall check of the device, including safety check and function check, should be performed by qualified personnel every 6 to 12 months, and each time after service. The equipment should undergo periodic safety testing to ensure proper patient isolation from live parts. This should include leakage current measurement and insulation testing. The recommended testing interval is once a year or as specified in the institution’s test and inspection protocol. (3) Mechanical Inspection Make sure all exposed screws are tight. Check the external cables for splits, cracks or signs of twisting. Replace any cable that shows serious damage. Pay particular attention to the supply socket. WARNING Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. CAUTION The maintenance must be performed by professional personnel. 6.2 Maintenance Avoid scratching and damaging the LCD. The gathering of dew on the LCD may occur with abrupt temperature or humidity changes. A table environment is recommended for the main unit. Keep the exterior surface of the main unit clean, free of dust and dirt.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Maintenance and Cleaning - 27 - Handle the probe with care to avoid damaging the cover, piezoelectric crystals and mechanical movement. Do not contact the probe with hard or sharp objects. Do not excessively flex the probe cable. Wipe the remaining gel off the probe after use. Keep the probes in a dry environment, where the temperature should be lower than 45°C. 6.3 Cleaning To clean the main unit: Switch off the Doppler and unplug it from AC power supply. Clean the case 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. The recommended cycle is one week or when needed. Clean the probe after each use to avoid cross infection and prolong its useful life. To clean the probe: Switch off the probe. 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. CAUTION 1 Do not use strong solvent such as acetone. 2 Do not use an abrasive such as steel wool or metal polish. 3 Neither the main unit nor the probe is waterproof; do not immerse any part of them in liquid. Entry of liquid into the Doppler may destroy the equipment. 4 Do not allow any liquid remain on the surface. 6.4 Disinfection In normal use the main unit 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. After each use, clean the probe 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Maintenance and Cleaning - 28 - 6.5 Sterilization Do not sterilize the Doppler, unless this is necessary according to your hospital regulation. NOTE: After cleaning or disinfection, check if the Doppler function well. If any problem is detected, please contact the manufacturer for service before reusing them. Checking Item Checking Method Visual Check Inspect the Doppler for any damage. Function Check Check if the Doppler can be switched on or off properly (see 3.5 Switching On and 3.6 Switching Off). When the Doppler is switched on, check if the LCD works as described in 2.5 LCD; touch the probe faceplate gently with your hand and check if the Doppler gives out sound normally.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Warranty and Service - 29 - Chapter 7 Warranty and Service 7.1 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 repaired. 7.2 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications - 30 - Chapter 8 Product Specifications 8.1 Environmental Specifications Working Temperature: 0ºC ~ + 40ºC ( +32ºF ~ +104ºF) Relative Humidity: 15% RH ~ 95% RH (non-condensing) Atmospheric Pressure: 86 kPa ~ 106 kPa Transport and Storage Temperature: -20ºC ~ +55ºC (-4ºF ~ +131ºF) Relative Humidity: 15% RH ~ 95% RH (non-condensing) Atmospheric Pressure: 70 kPa ~ 106 kPa 8.2 Physical Specifications Dimensions and Weight Dimensions: Main Unit: 265 mm x 155 mm x 180 mm Probes: 140 mm x 40 mm x 32 mm Weight: Main Unit: 1.7 kg (with battery and probe) Wireless Probe: <140 g (with battery) Wired Probe: <100 g Power Supply Main unit Operating Voltage: 100 V-240 V~ Operating Frequency: 50 Hz/60 Hz Input Power: 35 VA Battery: 7.2 V/2000 mAh (Ni-MH Battery) Probe Battery: 3.7 V/800 mAh (Lithium Battery) Standards Compliance IEC 60601-1:2005, EN 60601-1:2006, IEC 60601-1-2:2007, EN 60601-1-2:2007, IEC/EN 60601-2-37 Anti-electric Shock Type Class I equipment with internal power supply Anti-electric Shock Degree Type BF applied parts
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications - 31 - Degree of Protection against Harmful Ingress of Water Main Unit: Ordinary equipment (Sealed equipment without liquid proof) Probe: IPX4 Degree of Safety in Presence of Flammable Gases Equipment not suitable for use in presence of flammable gases Disinfection/Sterilizing Method Refer to this user manual for details EMC CISPR 11 Group1 Class A Earth Leakage Current (Limit): N.C. S.F.C. 500 µA 1000 µA Enclosure Leakage Current (Limit): N.C. S.F.C. 100 µA 500 µA Patient Leakage Current (Limit): N.C. S.F.C. d.c. 10 µA 50 µA a.c. 10 µA 50 µA Patient Auxiliary Current (Limit): N.C. S.F.C. d.c. 10 µA 50 µA a.c. 10 µA 50 µA Display: Effective display area: 62.0 mm (W) x 44.0 mm (H) Number of characters: 128*64 Dots Dot size: 0.39 mm (W) x 0.55 mm (H) Dot pitch: 0.44 mm (W) x 0.60 mm (H) Ultrasonic Gel: pH: 5.5~8.0 Acoustic Impedance: 1.5x106 Pa.s/m ~1.7x106 Pa.s/m (in 35°C(95ºF)) 8.3 Performance Specifications FHR Performance (Essential Performance): FHR Measurement Range: 50 bpm ~ 240 bpm Accuracy: ± 2 bpm FHR Resolution: 1 bpm Recording and Playing: Audio Sampling Frequency: 4 kHz Recording Length: 240 seconds White Back Light: Two Brightness Adjustable: OFF, ON
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications - 32 - Audio Output Power: 3 W Auto Shut off: 1-minute/3-minute no signal and no operation Bluetooth Transmission Distance: Photopic vision: >5 m (the indoor distance depends on the building structure and material) Ultrasound: Nominal Frequency: 2 MHz Wired /Wireless Probes: 2 MHz 3 MHz Wired /Wireless Probes: 3 MHz Working Frequency: 2 MHz Wired /Wireless Probes: (2.0 ± 10%) MHz 3 MHz Wired /Wireless Probes: (3.0 ± 10%) MHz 2 MHz Wired/wireless probe: Iob < 20 mW/cm2 3 MHz Wired/wireless probe: p- < 1 MPa Ispta < 100 mW/cm2 Isata < 20 mW/cm2 W0 < 50mW Working Mode: Continuous wave Doppler Effective Radiating Area of Probe: 2 MHz /3 MHz Wired /Wireless probes: (245±15%) mm2 8.4 Battery Specifications For main unit For probe Type: Ni-MH Battery Lithium Battery Nominal Capacity: 2000 mAh 800 mAh Nominal Voltage: 7.2 V 3.7 V Necessary Charge Time: ≤5 hours (the main unit is in the stand-by or switch off state) ≤5 hours (the probe is in the switch off state) Expected Battery Life: ≥8 hours (the new battery is fully charged before use, and the fetal heart sound at 1 meter right ahead of the main unit speaker is higher than 80 dB) ≥3 hours (the new battery is fully charged before use)
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications - 33 - Circle Life: ≥300 times (after 300 circles, only 90% of the capacity can be restored.) Storage Temperature: -20°C ∼ +60°C (-4 ºF ~ +140 ºF) (1 month) or -20°C ∼ +40°C (-4 ºF ~ +104 ºF) (3 months) 8.5 Low Output Summary Table Low Output Summary Table (for systems with no transducers having global maximum index values exceeding 1.0) System: Ultrasonic TableTop Doppler Transducer Model (MHz) Ispta.3 (mW/cm2) TI Type TI Value MI Isppa.3 (W/cm2) CW 2.0 (SD5) 1.774 TIS 0.0159 0.00628 0.001774 TIB 0.0301 CW 3.0 (SD5) 5.867 TIS 0.0969 0.00813 0.005867 TIB 0.1113 CW 2.0 (SD6) 3.484 TIS 0.0203 0.00785 0.003484 TIB 0.0531 CW 3.0 (SD6) 5.307 TIS 0.1132 0.00763 0.005307 TIB 0.1141
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ordering Information - 34 - Appendix 1 Ordering Information CAUTION Only the parts supplied by the manufacturer should be used with the Doppler. Parts Part Number Probe 2 MHz Wired Probe 02.01.212045 3 MHz Wired Probe 02.01.212046 Probe Cable 01.13.036108 2 MHz Wireless Probe 02.01.212047 3 MHz Wireless Probe 02.01.212048 Accessory Ni-MH Battery for Main Unit 01.21.064220 Lithium Battery for Wireless Probe 01.21.064125 Carry Bag 01.56.465630 Power Cord (European Standard) 01.13.036638 Power Cord (American Standard) 21.13.036384
SD5/SD6 Ultrasonic TableTop Doppler User Manual EMC Information - 35 - Appendix 2 EMC Information A2.1 Electromagnetic Emissions Guidance and manufacture’s declaration- electromagnetic emission The SD5/SD6 is intended for use in the electromagnetic environment specified below. The customer or the user of the SD5/SD6 should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment-guidance RF emissions CISPR 11 Group 1 The SD5/SD6 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class A The SD5/SD6 is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies building used for domestic purposes. Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/flicker emissions IEC61000-3-3 Complies
SD5/SD6 Ultrasonic TableTop Doppler User Manual EMC Information - 36 - A2.2 Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity The SD5/SD6 is intended for use in the electromagnetic environment specified below. The customer or the user of SD5/SD6 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment -guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV 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/burst IEC 61000-4-4 ±2 kV for power supply lines ±2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1 kV line(s) to line(s) ±2 kV line(s) to earth ±1 kV line(s) to line(s) ±2 kV line(s) to earth Mains power quality should be that of a typical commercial or hospital environment. Power frequency (50 Hz/60 Hz) magnetic field IEC61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5s <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5s Mains power quality should be that of a typical commercial or hospital environment. If the user of the SD5/SD6 requires continued operation during power mains interruptions, it is recommended that the SD5/SD6 be powered from an uninterruptible power supply or a battery. NOTE UT is the a.c. mains voltage prior to application of the test level.
SD5/SD6 Ultrasonic TableTop Doppler User Manual EMC Information - 37 - A2.3 Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity The SD5/SD6 is intended for use in the electromagnetic environment specified below. The customer or the user of SD5/SD6 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment -guidance Portable and mobile RF communications equipment should be used no closer to any part of the SD5/SD6 , including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 3 Vrms 150 z to 80 MHz 3Vrms 0.1 Vrms 1.995MHz~2.010MHz 2.985MHz~3.015MHz d=1.2P d=35 P 1.995 MHz to 2.010 MHz d=35 P 2.985 MHz to 3.015 MHz Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m d=1.2 P 80 MHz to 800 MHz d=2.3 P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
SD5/SD6 Ultrasonic TableTop Doppler User Manual EMC Information - 38 - a 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 SD5/SD6 is used exceeds the applicable RF compliance level above, the SD5/SD6 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SD5/SD6 b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. A2.4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the SD5/SD6 The SD5/SD6 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SD5/SD6 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SD5/SD6 as 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 d=1.2P (d=35 P 1.995 MHz to 2.010 MHz 2.985 MHz to 3.015 MHz) 80 MHz to 800 MHz D=1.2P 800 MHz to 2.5 GHz D=2.3P 0.01 0.12(3.5) 0.12 0.23 0.1 0.38(11.1) 0.38 0.73 1 1.2(35) 1.2 2.3 10 3.8(111) 3.8 7.3 100 12(350) 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ultrasound Intensity and Safety - 39 - Appendix 3 Ultrasound Intensity and Safety A3.1 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. A3.2 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). A3.3 Explanation of MI/TI A3.3.1 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 0.3dB/cm/MHz) to the acoustic frequency.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ultrasound Intensity and Safety - 40 - MI = Pr, α fawf × CMI CMI = 1 (MPa / MHz ) A3.3.2 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 thermophysical 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. According to different thermophysical 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. A3.3.3 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: ± 23 percent for intensity, ± 11.5 percent for pressure. Based on the hydrophone calibration report by ONDA. The uncertainty was determined within ±1dB in frequency range 1-15MHz. 2. Digitizer: ±3 percent for intensity. ± 1.5 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: ± 1 percent Based on the temperature variation of the water bath of ± 1 ºC. 4. Spatial Averaging: ± 10 percent for intensity, ± 5 percent 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 ± 25.1 percent for all intensity values reported, ± 12.7 percent for all the pressure values and ± 12.6 percent for the Mechanical Index. A3.4 Prudent Use Statement Although no confirmed bioeffects on patients caused by exposure from present diagnostic
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ultrasound Intensity and Safety - 41 - 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. A3.5 References 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. A3.6 Probe Acoustic Output Parameters List Acoustic Output Reporting Table for Track 1 Non-autoscanning Mode Operating Mode: CW mode Transducer: CD2.0 Working Frequency: 2.0MHz Acoustic Output MI ISPTA.3 (mW/cm^2) ISPPA.3 (W/cm^2) Global Maximum Value 0.02154 30.52 0.03052 Associated Acoustic Parameter Pr.3 (MPa) 0.03047 W0 (mW) 32.09 32.09 fc (MHz) 2.00 2.00 2.00 Zsp (cm) 3.78 3.78 3.78 Beam dimensions X-6 (cm) 2.449 2.449 Y-6 (cm) 0.1658 0.1658 PD (usec) N/A N/A PRF (Hz) N/A N/A EBD Az. (cm) Φ1.7678 Ele. (cm) Φ1.7678 Operating Control Conditions Fixed
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ultrasound Intensity and Safety - 42 - Acoustic Output Reporting Table for Track 1 Non-autoscanning Mode Operating Mode: CW mode Transducer: CD3.0 Working Frequency: 3.0MHz Acoustic Output MI ISPTA.3 (mW/cm^2) ISPPA.3 (W/cm^2) Global Maximum Value 0.01342 17.45 0.01745 Associated Acoustic Parameter Pr.3 (MPa) 0.02325 W0 (mW) 43.90 43.90 fc (MHz) 3.00 3.00 3.00 Zsp (cm) 5.20 5.20 5.20 Beam dimensions X-6 (cm) 0.6228 0.6228 Y-6 (cm) 1.372 1.372 PD (usec) N/A N/A PRF (Hz) N/A N/A EBD Az. (cm) Φ1.7678 Ele. (cm) Φ1.7678 Operating Control Conditions Fixed
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity - 43 - Appendix 4 Overall Sensitivity A4.1 Overall Sensitivity of SD5 (2MHz Wired Probe) Diameter of Target Reflector (mm) Distance (d)(mm) Reflection Loss A(d) Two-way Attenuation B=∑Ba+Bw VS(r.m.s) mV Vn(r.m.s) mV ()( )=......log2010smrVsmrVCns dB Overall Sensitivity (S=A(d)+B+C) dB ∑B (T: ultrasonic attenuation phantom No. Ba:dB) Bw (dB) B (dB) 1.58 A=45.7dB@ 2MHz 50 39.8 T 6#6#6#1# 0 78.3 70.06 31.43 6.96 125.06 Ba 78.3 75 43.3 T 6#6#6# 0 74.6 69.39 29.83 7.33 125.23 Ba 74.6 100 45.8 T 6#6#5#4# 0 72.6 69.72 29.66 7.42 125.82 Ba 72.6 200 51.8 T 6#6#4#3# 0 67.6 54.04 29.35 5.30 124.70 Ba 67.6 2.38 A=43.2dB@ 2MHz 50 37.2 T 6#6#6#2# 0 80.0 60.47 31.09 5.78 122.98 Ba 80.0 75 40.7 T 6#6#6#1# 0 78.3 58.64 30.32 5.73 124.73 Ba 78.3 100 43.2 T 6#6#6#1# 0 78.3 63.61 30.74 6.32 127.82 Ba 78.3 200 49.2 T 6#6#4#3# 0 67.6 52.58 29.31 5.08 121.88 Ba 67.6 Doppler Frequency (Hz) 200 Velocity of Target (cm/s) 10
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity - 44 - A4.2 Overall Sensitivity of SD5 (3MHz Wired Probe) Diameter of Target Reflector (mm) Distance (d)(mm) Reflection Loss A(d) Two-way Attenuation B=∑Ba+Bw VS(r.m.s) mV Vn(r.m.s) mV ()( )=......log2010smrVsmrVCns dB Overall Sensitivity (S=A(d)+B+C) dB ∑B (T: ultrasonic attenuation phantom No. Ba:dB) Bw (dB) B (dB) 1.58 A=44.5dB@ 3MHz 50 40.9 T 6#5#3# 0 79.4 64.45 31.07 6.34 126.64 Ba 79.4 75 44.4 T 6#5#3# 0 79.4 60.2 29.59 6.17 129.97 Ba 79.4 100 46.9 T 6#4#1#2# 0 77.7 69.53 29.58 7.42 132.02 Ba 77.7 200 52.9 T 6#4#1# 0 68.1 59.84 29.52 6.14 127.14 Ba 68.1 2.38 A=42.0dB@ 3MHz 50 39.0 T 6#5#2#1# 0 82.0 61.84 30.32 6.19 127.19 Ba 82.0 75 42.5 T 6#4#3#1# 0 81.6 60.0 30.4 6.01 130.11 Ba 81.6 100 45.0 T 6#4#3# 0 75.1 69.53 30.75 7.09 127.19 Ba 75.1 200 51.0 T 6#4#1# 0 68.1 57.63 29.56 5.80 124.90 Ba 68.1 Doppler Frequency (Hz) 380 Velocity of Target (cm/s) 10
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity - 45 - A4.3 Overall Sensitivity of SD6 (2MHz Wireless Probe) Diameter of Target Reflector (mm) Distance (d)(mm) Reflection Loss A(d) Two-way Attenuation B=∑Ba+Bw VS(r.m.s) mV Vn(r.m.s) mV ()( )=......log2010smrVsmrVCns dB Overall Sensitivity (S=A(d)+B+C) dB ∑B (T: ultrasonic attenuation phantom No. Ba:dB) Bw (dB) B (dB) 1.58 A=45.7dB@ 2MHz 50 39.8 T 6#6#6#2# 0 80.0 35.80 16.43 6.76 126.56 Ba 80.0 75 43.3 T 6#6#6#1# 0 78.3 36.47 16.04 7.13 128.73 Ba 78.3 100 45.8 T 6#6#5#4# 0 72.6 39.12 18.43 6.54 124.94 Ba 72.6 200 51.8 T 6#6#4#2# 0 65.4 42.0 19.45 6.69 123.89 Ba 65.4 2.38 A=43.2dB@ 2MHz 50 37.2 T 6#6#6#2# 0 80.0 46.71 16.37 9.12 126.32 Ba 80.0 75 40.7 T 6#6#6#2# 0 80.0 41.77 17.60 7.51 128.21 Ba 80.0 100 43.2 T 6#6#6#1# 0 78.3 39.95 18.23 6.81 128.31 Ba 78.3 200 49.2 T 6#6#5#4# 0 72.6 40.84 20.54 5.97 127.77 Ba 72.6 Doppler Frequency (Hz) 218 Velocity of Target (cm/s) 10
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity - 46 - A4.4 Overall Sensitivity of SD6 (3MHz Wireless Probe) Diameter of Target Reflector (mm) Distance (d)(mm) Reflection Loss A(d) Two-way Attenuation B=∑Ba+Bw VS(r.m.s) mV Vn(r.m.s) mV ()( )=......log2010smrVsmrVCns dB Overall Sensitivity (S=A(d)+B+C) dB ∑B (T: ultrasonic attenuation phantom No. Ba:dB) Bw (dB) B (dB) 1.58 A=44.5dB@ 3MHz 50 40.9 T 6#5#4#1# 0 90.3 39.57 18.31 6.69 137.89 Ba 90.3 75 44.4 T 6#5#3#1# 0 86.0 38.4 18.59 6.30 136.70 Ba 86.0 100 46.9 T 6#4#3# 0 75.1 45.32 19.96 7.12 129.12 Ba 75.1 200 52.9 T 6#4#3# 0 79.4 40.2 19.36 6.35 138.65 Ba 75.1 2.38 A=42.0dB@ 3MHz 50 39.0 T 6#5#4#1# 0 90.3 40.48 18.43 6.83 136.13 Ba 90.3 75 42.5 T 6#5#4# 0 83.8 38.1 19.26 5.93 132.23 Ba 83.8 100 45.0 T 6#4#3# 0 75.1 45.61 18.74 7.73 127.83 Ba 75.1 200 51.0 T 6#4#3# 0 75.1 47.56 19.47 7.76 133.86 Ba 75.1 Doppler Frequency (Hz) 377 Velocity of Target (cm/s) 10

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