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.
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.
Table of Contents Chapter 1 Safety Guide ................................................................................................................. 1 1.1 Intended Use/Indications for Use ........................................................................................ 1 1.2 Safety Precautions ............................................................................................................... 1 1.3 Symbols ..............................................................................
6.1 Inspection .......................................................................................................................... 26 6.2 Maintenance ...................................................................................................................... 26 6.3 Cleaning ............................................................................................................................ 27 6.4 Disinfection ...........................................................................
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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual 1.3 Symbols No.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide 18 TYPE BF APPLIED PART 19 CE marking 20 Disposal method 21 The device is protected against splashing water. Water splashed against the enclosure from any direction shall have no harmful effects. IPX4 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction Chapter 2 Introduction NOTE: The pictures and interfaces in this manual are for reference only. 2.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction WARNING Please do not touch the probe sensor socket and the patient simultaneously.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction 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).
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction 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 6 7 8 9 1 2 10 3 11 4 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual 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 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.
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.
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.
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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation RJ11 Interface: 1 2 3 4 Power 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.
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 (if the key sound is enabled) is heard.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual FHR Examining 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual FHR Examining 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Recording and Playing 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 LCD lights up. Recording starts. Press the Record/Play control key examining mode. for two seconds.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Maintenance and Cleaning 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Maintenance and Cleaning 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Maintenance and Cleaning 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Warranty and Service 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications Chapter 8 Product Specifications 8.1 Environmental Specifications Working Transport and Storage Temperature: 0ºC ~ + 40ºC ( +32ºF ~ +104ºF) Relative Humidity: 15% RH ~ 95% RH (non-condensing) Atmospheric Pressure: 86 kPa ~ 106 kPa Temperature: -20ºC ~ +55ºC (-4ºF ~ +131ºF) Relative Humidity: 15% RH ~ 95% RH (non-condensing) Atmospheric Pressure: 70 kPa ~ 106 kPa 8.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Degree of Protection Harmful Ingress of Water Product Specifications Main Unit: Ordinary equipment (Sealed equipment against 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. 500 µA S.F.C.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications Audio Output Power: 3W 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: 2 MHz Wired /Wireless Probes: 2 MHz Nominal Frequency: 3 MHz Wired /Wireless Probes: 3 MHz 2 MHz Wired /Wireless Probes: (2.0 ± 10%) MHz Working Frequency: 3 MHz Wired /Wireless Probes: (3.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications ≥300 times (after 300 circles, only 90% of the capacity can be restored.) Circle Life: -20°C ∼ +60°C (-4 ºF ~ +140 ºF) (1 month) or Storage Temperature: -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) CW 2.0 (SD5) 1.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ordering Information 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual EMC Information 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual EMC Information 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual EMC Information 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual a b EMC Information 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ultrasound Intensity and Safety 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ultrasound Intensity and Safety 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).
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ultrasound Intensity and Safety 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ultrasound Intensity and Safety Acoustic Output Reporting Table for Track 1 Non-autoscanning Mode Operating Mode: CW mode Transducer: CD3.0 Working Frequency: 3.0MHz Acoustic Output MI Global Maximum Value Pr.3 W0 fc Zsp 0.01342 0.02325 Associated Acoustic Parameter Beam dimensions PD PRF EBD (MPa) (mW) (MHz) (cm) X-6 (cm) Y-6 (cm) (usec) (Hz) Az. (cm) Ele. (cm) Operating Control Conditions 3.00 5.20 ISPPA.3 (W/cm^2) 0.01745 43.90 3.00 5.20 0.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity Appendix 4 Overall Sensitivity A4.1 Overall Sensitivity of SD5 (2MHz Wired Probe) Diameter of Target Reflector (mm) 1.58 A=45.7dB@ 2MHz 2.38 A=43.2dB@ 2MHz Two-way Attenuation B=∑Ba+Bw Distance Reflection (d)(mm) Loss A(d) ∑B (T: ultrasonic attenuation Bw phantom No. Ba:dB) (dB) T 6#6#6#1# 50 39.8 0 Ba 78.3 T 6#6#6# 75 43.3 0 Ba 74.6 T 6#6#5#4# 100 45.8 0 Ba 72.6 T 6#6#4#3# 200 51.8 0 Ba 67.6 T 6#6#6#2# 50 37.2 0 Ba 80.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity A4.2 Overall Sensitivity of SD5 (3MHz Wired Probe) Diameter of Target Reflector (mm) 1.58 A=44.5dB@ 3MHz 2.38 A=42.0dB@ 3MHz Two-way Attenuation B=∑Ba+Bw Distance Reflection (d)(mm) Loss A(d) ∑B (T: ultrasonic attenuation Bw phantom No. Ba:dB) (dB) T 6#5#3# 50 40.9 0 Ba 79.4 T 6#5#3# 75 44.4 0 Ba 79.4 T 6#4#1#2# 100 46.9 0 Ba 77.7 T 6#4#1# 200 52.9 0 Ba 68.1 6#5#2#1# T 0 50 39.0 Ba 82.0 T 6#4#3#1# 75 42.5 0 Ba 81.6 T 6#4#3# 100 45.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity A4.3 Overall Sensitivity of SD6 (2MHz Wireless Probe) Diameter of Target Reflector (mm) 1.58 A=45.7dB@ 2MHz 2.38 A=43.2dB@ 2MHz Two-way Attenuation B=∑Ba+Bw Distance Reflection (d)(mm) Loss A(d) ∑B (T: ultrasonic attenuation phantom No. Ba:dB) 50 39.8 75 43.3 100 45.8 200 51.8 50 37.2 75 40.7 100 43.2 200 49.2 Doppler Frequency (Hz) T Ba T Ba T Ba T Ba T Ba T Ba T Ba T Ba 6#6#6#2# 80.0 6#6#6#1# 78.3 6#6#5#4# 72.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity A4.4 Overall Sensitivity of SD6 (3MHz Wireless Probe) Diameter of Target Reflector (mm) 1.58 A=44.5dB@ 3MHz 2.38 A=42.0dB@ 3MHz Two-way Attenuation B=∑Ba+Bw Distance Reflection (d)(mm) Loss A(d) ∑B (T: ultrasonic attenuation Bw phantom No. Ba:dB) (dB) T 6#5#4#1# 50 40.9 0 Ba 90.3 T 6#5#3#1# 75 44.4 0 Ba 86.0 T 6#4#3# 100 46.9 0 Ba 75.1 T 6#4#3# 200 52.9 0 Ba 75.1 6#5#4#1# T 0 50 39.0 Ba 90.3 T 6#5#4# 75 42.5 0 Ba 83.8 T 6#4#3# 100 45.