About this Manual P/N: 01.54.110755-13 Release Date: July 2012 © Copyright EDAN INSTRUMENTS, INC. 2009-2012. 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.
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 Safety Precautions...............................................................................................................1 1.2 Symbols...............................................................................................................................2 Chapter 2 Introduction...........................................................
4.2 Vascular Examining ..........................................................................................................22 Chapter 5 Recording and Playing ..............................................................................................24 Chapter 6 Maintenance and Cleaning........................................................................................25 6.1 Inspection ...............................................................................................................
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide Chapter 1 Safety Guide NOTE: Familiarize yourself with this user manual before attempting to operate the Doppler. Follow the operation and maintenance instructions to ensure proper use of it. 1.1 Safety Precautions WARNING and CAUTION messages must be observed. To avoid the possibility of injury, observe the following precautions during the operation of the device.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide CAUTION 7 Check that the equipment does not have visible evidence of damage that may affect personnel’s safety or examining capability before use. If damage is detected, replacement is recommended. 8 The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide Caution. Refer to accompanying documents. Consult Instructions for Use Type B applied part. This symbol indicates the unit is internally powered equipment, and the degree of protection against electrical shock is type B. The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction Chapter 2 Introduction 2.1 Intended Use The SD5 Ultrasonic TableTop Doppler (hereinafter called “SD5”) and SD6 Ultrasonic TableTop Doppler (hereinafter called “SD6”) are intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction 8 9 8 Probe Holder 9 Handle 10 10 Probe Sensor Socket 11 Main Unit Control Keys 11 Figure 2-2 Top View of the Main Unit 12 Main Unit Indicator 12 13 14 15 13 On/OFF Key 16 14 Setup Key / Confirm Key 15 Up Key / Record/Play Control Key 16 Down Key / Print Control Key Figure 2-3 Main Unit Control Keys 20 17 Fuses 21 17 18 Power Socket 19 Equipotential Grounding Terminal 20 Main Unit Label 18 22 21 Security Slot 22 Earphone Socket 19
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction NOTE: The main unit is not waterproof. Do not immerse it in any type of liquid. 2.2.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction Description: The Doppler supports 2MHz, 3MHz, 4MHz, 5MHz and 8MHz probes supplied by the manufacturer. The probe nominal frequency is disclosed on the probe type label. Probes of SD5 are wired, while probes of SD6 are wireless. WARNING 1 Do not touch the charge sockets of the Wireless Doppler probe and the patient at the same time. 2 Do not immerse the probes or the probe cable in any liquid.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction 2.2.4 Indicators (1) Main unit indicator The indicator of the main unit indicates the connection status of the main unit and AC power: The indicator lights up in green – the AC power is connected. The indicator flashes in green – the main unit is charging the main unit battery. The indicator goes off – the AC power is not connected.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Infrared Indicator (Only available with SD6) 5 Probe Indicator (Only available with SD5) 6, 7 Introduction Infrared signal is received. Infrared signal is not received, indicating that poor quality signal is received. The probe is well connected. The probe is not connected. Date and Time 8 Heart Beat Indicator: When fetal heart signal is received, the heart shape flashes to indicate the FHR refreshing frequency.
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 of batteries shall be done at least 1.5 meters away from the patient. 2 Close the battery compartment before using the main unit or the probe. 3 Charge the battery with specified charger only. 4 Do not expose the batteries to high temperatures, heat them or dispose of them in fire. 5 Do not disassemble the batteries. 6 Short circuit should be avoided.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation RJ11 Interface: 1 2 3 4 Power VCC +5V GND Signal Wire Signal Wire 3.4.2 Connecting and Disconnecting a Wired Probe To connect the wired probe to the main unit, 1 Take out the probe cable from package. Insert one modular plug of the cable into the probe socket of the main unit. 2 Insert the other modular plug into the probe socket of the probe. Modular Plug To disconnect the probe, press the housing of the modular plug and then pull it out.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation CAUTION To avoid unwanted noise, do not take out or place the probe when the main unit is on. Remember to take out the probe before switching on the main unit, and place the probe after switching off the main unit. To switch on the main unit, Pick up the probe and then press the ON/OFF key on the main unit. All the real-time examining menu elements light up in a few seconds. A start-up sound is heard.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 3.7 Using Earphone In a noisy environment, the earphone is recommended to hear ideal 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 3 The lock is securely attached to the main unit. Hitch the device to a stationary object. To unlock the main unit, Insert the key into the lock slot. Apply a certain amount of pressure to the key and then rotate it clockwise. The lock hook is open and you can remove the lock from the main unit.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 3.9 Changing Doppler Settings 3.9.1 Switching Backlight On and Off 1 Press the Setup key 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. 3.9.2 Switching Key Sound On and Off 1 Press the Setup key to open setup menu. 2 Press the Up/Down key to move the cursor to Key Sound, press the Setup key.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation 3.9.6 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 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Examining Chapter 4 Examining WARNING Always check if the main unit and the probe are in good condition prior to use. CAUTION Handle the probe with care. Do not drop it on hard surfaces. 4.1 FHR Examining The 2MHz and 3MHz obstetrical probes are designed for FHR examining. The 2MHz probe is optimized for deep penetration and is widely used in the third trimester pregnancy. The 3MHz probe is a general purpose probe.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Examining Special notes for using SD6: 1 To ensure good communication, make sure there is no barrier between the infrared sender on the probe and the infrared receivers on the main unit. Aiming the infrared sender of the probe to the main unit allows the best communication result. 2 To avoid signal interference, do not switch on two or more SD6 wireless probes in the same area synchronously.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Examining Vertebral Artery (5MHz) Carotid Artery (5/8MHz) Carotid Artery (5/8MHz) Jugular Vein (5MHz) Subclavian Artery (5MHz) Subclavian Vein (5MHz) Brachial Artery (8MHz) Ulner Artery (8MHz) Radial Artery (8MHz) Femoral Artery (5MHz) Femoral Vein (5MHz) Popliteal Artery (5MHz) Great Saphenous Vein (5/8MHz) Small Saphenous Vein (8MHz) Posterior Tibial Artery (8MHz) Dorsalis Pedis Artery (8MHz) Posterior Tibial Vein (8MHz) Figure 4-1 Probe sites
SD5/SD6 Ultrasonic TableTop Doppler User Manual Recording and Playing Chapter 5 Recording and Playing The built-in recorder of the Doppler provides recording and playing fetal heart sound of 240 seconds (at most). To record fetal heart sound, for two seconds. The character REC on the Press and hold the Record/Play control key LCD lights up. Recording starts. Press the Record/Play control key examining mode.
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 had better 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 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: +5 ºC ~+ 40 ºC ( +41 ºF ~ +104 ºF) Relative Humidity: 25% ~ 80% (non-condensing) Atmospheric Pressure: 860hPa ~ 1060hPa Temperature: -20 ºC ~ +55 ºC (-4ºF ~ +131 ºF) Relative Humidity: 25% ~ 93% (non-condensing) Atmospheric Pressure: 700hPa ~ 1060hPa 8.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Degree of Protection Harmful Ingress of Water Product Specifications against Main Unit: Not-protected 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 Group I Class A Earth Leakage Current (Limit): N.C. 500µA S.F.C. 1000µA Enclosure Leakage Current (Limit): N.C. 100µA S.F.C.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications Ultrasound: 2MHz Wired /Wireless Probes: 2MHz 3MHz Wired /Wireless Probes: 3MHz Nominal Frequency: 4MHz Wired /Wireless Probes: 4MHz 5MHz Wired /Wireless Probes: 5MHz 8MHz Wired /Wireless Probes: 8MHz 2MHz Wired /Wireless Probes: (2.0 ± 10%)MHz 3MHz Wired /Wireless Probes: (3.0 ± 10%)MHz Working Frequency: 4MHz Wired /Wireless Probes: (4.0 ± 10%)MHz 5MHz Wired /Wireless Probes: (5.0 ± 10%)MHz 8MHz Wired /Wireless Probes: (8.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications Nominal Capacity: 2000mAh 700mAh Nominal Voltage: 7.2V 3.7V Charge Current (Standard): 757mA 500mA Charge Voltage (Standard): 9V 4.2V Necessary Charge Time Approx. 3h 4h ~ 5h Expected Battery Life: Approx. 10h Approx. 3h Charge Mode: Constant current/Constant voltage Circle Life: ≥300 times (after 300 circles, only 90% of the capacity can be restored.
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 12.01.110744 3 MHz Wired Probe 12.01.110745 4 MHz Wired Probe 02.01.110767 5 MHz Wired Probe 02.01.110768 8 MHz Wired Probe 02.01.110769 Probe Cable 01.13.036108 2 MHz Wireless Probe 12.01.110746 3 MHz Wireless Probe 12.01.110747 4 MHz Wireless Probe 02.01.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Appendix 2 EMC Information Manufacture’s Declaration EMC Information – Guidance and A2.1 Electromagnetic Emissions- For all EQUIPMENT and SYSTEMS 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 – for all EQUIPMENT and SYSTEMS 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 – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING 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 A2.4 Recommended separation distances between portable and mobile RF communication equipment and the EQUIPMENT or SYSTEM- For EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity Appendix 3 Overall Sensitivity A3.1 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 phantom No. Ba:dB) T 6# 6# 3# 50 45.7 Ba 24.9 24.9 7.7 T 6# 6# 2# 75 45.7 24.9 5.5 Ba 24.9 T 6# 6# 1# 100 45.7 24.9 3.7 Ba 24.9 T 6# 6# 200 45.7 24.9 Ba 24.9 T 6# 6# 2# 1# 50 43.2 24.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity A3.2 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 phantom No. Ba:dB) T 6# 3# 50 44.5 Ba 43.6 13.5 T 6# 3# 75 44.5 13.5 Ba 43.6 T 6# 2# 100 44.5 9.6 Ba 43.6 T 6# 1# 200 44.5 6.5 Ba 43.6 T 6# 3# 50 42.0 13.5 Ba 43.6 T 6# 2# 75 42.0 9.6 Ba 43.6 T 6# 2# 100 42.0 9.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity A3.3 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) T 6# 6# 3# 50 45.7 Ba 24.9 24.9 7.7 T 6# 6# 2# 75 45.7 24.9 5.5 Ba 24.9 T 6# 6# 1# 100 45.7 24.9 3.7 Ba 24.9 T 6# 6# 200 45.7 24.9 Ba 24.9 T 6# 6# 3# 50 43.2 24.9 7.7 Ba 24.9 T 6# 6# 3# 75 43.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity A3.4 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 phantom No. Ba:dB) T 6# 3# 50 44.5 Ba 43.6 13.5 T 6# 3# 75 44.5 13.5 Ba 43.6 T 6# 2# 100 44.5 9.6 Ba 43.6 T 6# 1# 200 44.5 6.5 Ba 43.6 T 6# 3# 50 42.0 13.5 Ba 43.6 T 6# 2# 75 42.0 9.6 Ba 43.6 T 6# 2# 100 42.0 9.
