About this Manual P/N: 01.54.458314 MPN: 01.54. 458314012 Release Date: December 2020 © Copyright EDAN INSTRUMENTS, INC. 2020. 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) cannot be held liable.
The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure.
Table of Contents Chapter 1 Safety Guidance ........................................................................................................... 1 1.1 Indications for Use/Intended Use ........................................................................................ 1 1.2 Warnings and Cautions ....................................................................................................... 1 1.2.1 General Warnings ...........................................................................
9.1 General Setting .................................................................................................................. 31 9.2 Patient Information Setting ............................................................................................... 31 9.3 Security Setting ................................................................................................................. 32 9.4 Communications Setting ..............................................................................
SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance Chapter 1 Safety Guidance This chapter provides important safety information related to the use of SA series ambulatory blood pressure monitor (as referred to below as ABPM). 1.1 Indications for Use/Intended Use The Ambulatory Blood Pressure Monitor is capable of measuring systolic and diastolic blood pressures, and pulse of adults and pediatrics (> 12 years) over a preprogrammed period of time.
SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance foreign objects. 3. Do not measure ambulatory blood pressure on patients with sickle-cell disease or any condition where skin damage has occurred or is expected. 4. Do not measure ambulatory blood pressure on the arm of the same side with a mastectomy. Too frequent measurements can cause injury to the PATIENT due to blood flow interference. 5.
SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance 17. Only service engineers authorized by the manufacturer can open the shell. Otherwise, safety hazards may happen. 18. EXPLOSION HAZARD - Do not use the system in the presence of flammable anesthetic mixtures with oxygen or other flammable agents. 19. If multiple instruments are connected to a patient, the sum of the leakage currents may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard.
SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance 32. Assembly of the ABPM and modifications during actual service life shall be evaluated based on the requirements of IEC60601-1. 33. The equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. 34. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance 1 It is suggested that the user should not start ambulatory BP measuring when the low battery displays, or the monitor may be turned off automatically. 2 If you spill liquid onto the equipment or accessories, particularly if there is a chance that it can get inside the tubing or the measurement device, contact your service personnel. 3 BP measurement value should be explained by qualified professionals.
SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance security configuration, etc. 4 Protect all the passwords to prevent unauthorized changes. 5 Anti-virus measures such as USB device virus scanning should be carried out prior to using USB flash drive. 6 Firewalls and/or other security devices should be in place between the medical system and any externally accessible systems.
SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance installing the battery. 4. Do not heat or splash the battery or throw it into fire or water. 5. Do not destroy the battery; do not pierce 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. 6. When leakage or foul smell is found, stop using the battery immediately.
SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance required for the ABPM to cool from the maximum storage temperature between uses until it is ready for intended use is at least 2 hours. 6. The monitor should not be modified in any way. 7. Federal (U.S.) law restricts this device to sale by or on the order of a physician. 1.2.5 Contraindications Do not use on patients with erratic, accelerated or mechanically controlled irregular heart rhythms, including patient with arrhythmias.
SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance 1.3 List of Symbols No. Symbol Description 1 DEFIBRILLATION-PROOF TYPE BF APPLIED PART 2 USB socket 3 On/Off button 4 Start/Stop button 5 IP 22 Protected against solid foreign objects of 12.
SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance 13 AUTHORISED REPRESENTATIVE EUROPEAN COMMUNITY 14 CE marking 15 Disposal method 16 Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
SA Series Ambulatory Blood Pressure Monitor User Manual 26 27 Front FCC ID: SMQSAEDAN Federal Communications Commission: FCC ID: SMQSAEDAN NOTE: The user manual is printed in black and white.
SA Series Ambulatory Blood Pressure Monitor User Manual Introduction Chapter 2 Introduction 2.1 About ABPM The Ambulatory Blood Pressure Monitor consists of a blood pressure monitor (as referred to below as monitor) and analysis software. The monitor inflates and deflates the cuff on the upper arm to measure blood pressure by the oscillometric method and stores the measurement. The stored measurements are transferred to a PC via wired or wireless transmission and analyzed by the analysis software.
SA Series Ambulatory Blood Pressure Monitor User Manual Introduction 2.2 ABP Monitor at a Glance 1 2 6 5 1 / OLED screen 2 / Hose connection Start/Stop button 3 4 On/Off button 5 Type-C interface 6 / Battery compartment 4 3 Displaying time, automatic or manual BP readings. To connect the extension hose from the cuff to monitor for an ambulatory BP study. To start a programmed ABP study: when 24-hour time is displayed, press this button to take first reading.
SA Series Ambulatory Blood Pressure Monitor User Manual Introduction CAUTION The ABP monitor cannot be charged. DO NOT use the type-C interface for charging. Keys/Icons Description Bluetooth connection If this icon is not seen on the display, you need to match the device manually. Event mark When this icon flashes, it indicates you can enter a patient activity. When this icon flashes, it indicates low battery.
SA Series Ambulatory Blood Pressure Monitor User Manual Setting Up ABPM Chapter 3 Setting up ABPM Setting up the ABPM involves powering on the BP monitor, installing the analysis software on a personal computer (PC), and connecting the BP monitor to the PC. The ABPM is packaged with everything you need to start. See Accessories for complete contents. 3.1 Powering the Monitor for Use Install two AA batteries in the bay located at the back of the monitor.
SA Series Ambulatory Blood Pressure Monitor User Manual Setting Up ABPM 3.4 Connecting the Monitor to PC When the analysis software is installed and logged in, you can connect the ABP monitor to your PC by a USB cable. 1. Connect the Type-C end of the cable to the Type-C interface of the ABP monitor. 2. Connect the USB end of the cable to the USB port on your PC.
SA Series Ambulatory Blood Pressure Monitor User Manual Setting Up ABPM 5. If the Bluetooth adapter provided by the manufacturer is lost, the UGREEN Bluetooth 4.0 adapters are recommended.
SA Series Ambulatory Blood Pressure Monitor User Manual Main Screen of Analysis Software Chapter 4 Main Screen of Analysis Software The analysis software allows you to program the monitor, collect and retrieve important test data, and analyze the data. After login to the software, you enter the main screen (BP data screen). Menu Patient query Folder Patient list Button Menu Program: Enter patient information and set the BP study program BP data: Opens the main screen above.
SA Series Ambulatory Blood Pressure Monitor User Manual Main Screen of Analysis Software Patient query Enter patient ID or names, fully or partially, for searching from the patient list. Patient list A list that shows patient’s personal information and measurement readings. Button • Import: Imports single or multiple BP files that were exported before from your PC. • Export: Exports single or multiple BP files to your PC. • Delete: Deletes data from the patient list.
SA Series Ambulatory Blood Pressure Monitor User Manual Conducting an Ambulatory BP Study Chapter 5 Conducting an Ambulatory BP Study 5.1 Programming the Monitor Before an ambulatory BP study, you need to set the parameters for your study to be programmed into the monitor as below. 1. Click Program in the main screen. 2. Enter patient ID, name, gender, age, and accession number. For the generation of patient ID, see section 9.1 General Setting. Patient information can be customized.
SA Series Ambulatory Blood Pressure Monitor User Manual Conducting an Ambulatory BP Study Note: 1. You can use a barcode reader to enter the patient information if barcode scanning is activated. The recommended readers are Motorola LS4208 for one dimension and Honeywell Xenon 1500GSR for two dimensions. 2. You can also retrieve patient information via GDT in the Program screen. Select Setting > GDT > Enable GDT. 3. Patient information with an asterisk * is mandatory, for example, patient name and ID.
SA Series Ambulatory Blood Pressure Monitor User Manual Cuff sleeve Conducting an Ambulatory BP Study Metal bar Moving range 3. Connect the hose. Connect the hose from the cuff and monitor by twisting the fittings together until you hear a snap. Drape the hose over the patient’s shoulder, behind the neck and across to the opposite side of the body. 4. Attach to patient. Put the monitor into its pouch. Attach the pouch to the patient using a pouch strap.
SA Series Ambulatory Blood Pressure Monitor User Manual Conducting an Ambulatory BP Study WARNING Prolonged non-invasive blood pressure measurements in Auto mode may be associated with purpura, ischemia and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the extremities of the limb frequently for normal color, warmth and sensitivity. If any abnormality is observed, stop the blood pressure measurements. 5.
SA Series Ambulatory Blood Pressure Monitor User Manual Conducting an Ambulatory BP Study Patients with excessive and continuous movement such as shivering or convulsions. Patients with rapid blood pressure changes. Patients with severe shock or hypothermia that reduces blood flow to the peripheries. Patients with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery. Patients on an edematous extremity. 5.
SA Series Ambulatory Blood Pressure Monitor User Manual Retrieving ABP Data Chapter 6 Retrieving ABP Data BP readings can be affected by the measurement site, the position of the patient, exercise, or the patient's physiologic conditions. To retrieve the data: 1. Connect the ABP monitor to your PC. For operations, see section 3.4 Connecting the Monitor to PC. 2. In the Main Screen of analysis software, click Retrieve. The Retrieve window opens. Click OK. 3.
SA Series Ambulatory Blood Pressure Monitor User Manual Analyzing and Editing ABP Data Chapter 7 Analyzing and Editing ABP Data When data is successfully transferred to your PC, the data analysis screen will open automatically. To manually access this screen: 1. Open the Recorder DB. A patient list is displayed. 2. Enter patient ID or name in the search bar. If more than one study is conducted on this patient, the studies are listed in chronological order. 3. Double click the study you want.
SA Series Ambulatory Blood Pressure Monitor User Manual Analyzing and Editing ABP Data In this profile, X axis displays the time in clock hours. Y axis represents the blood pressure (mmHg) in the left and pulse rate (bmp) in the right. 24-hour BP curve: consists of 24-hour systolic and diastolic BP curves. • Threshold curves: drawn based on the threshold setting. • Vertical line: click any point in the profile.
SA Series Ambulatory Blood Pressure Monitor User Manual Analyzing and Editing ABP Data Compare: compares the BP studies of one patient conducted in different periods. 7.4 Correlation The graph on this tab plots the diastolic on systolic BP values for each measurement captured in the study. Additionally, this tab lists the calculated AASI (ambulatory arterial stiffness index) value and linear regression equation.
SA Series Ambulatory Blood Pressure Monitor User Manual Analyzing and Editing ABP Data 7.8 Statistics To view the statistical analysis for the displayed study, click on the Statistics tab. This window initially shows the following tables: • Overall: Data for the complete ABPM study. • Day: Data collected while the patient is awake. • Night: Data collected while the patient is asleep.
SA Series Ambulatory Blood Pressure Monitor User Manual Creating Reports Chapter 8 Creating Reports On the Data Analysis screen, you can configure or customize, preview, and print your report. The following preconfigured report formats are provided: • Simple report • Standard report • Full report You can choose from the pages available to customize your report. For more details, see section 9.5 Report Setting.
SA Series Ambulatory Blood Pressure Monitor User Manual System Setting Chapter 9 System Setting To open the system setting, tap Setting on the main screen. To save your changes in setting, click OK. You have the following options. The options with an underline are default settings. 9.1 General Setting Item Description ID Generation Choose from: Manual, Auto, or Accumulate. Mode Select Auto, the patient ID can be automatically generated according to the study date.
SA Series Ambulatory Blood Pressure Monitor User Manual System Setting diagnosis, medical history, medication, customize 1, and customize 2. You need to input the content for customize 1 and customize 2 if selected. 9.3 Security Setting Item Description Login password Allows for up to 30 numbers and letters for entry. Blank by default. System password setting Allows for up to 30 numbers and letters for entry. Blank by default.
SA Series Ambulatory Blood Pressure Monitor User Manual System Setting 9.5 Report Setting You can configure or customize your report. Item Description Hospital name You can enter up to 40 characters. After setting, the name is displayed on the printed report. Logo Click Browse to upload an image. The image must be in the format of JPG, BMP, and PNG. After setting, the image is displayed on the printed report.
SA Series Ambulatory Blood Pressure Monitor User Manual System Setting Two-dimensional barcode scanning is also supported. Patient ID Enter a number from 0 to 255. The default number is 1 to 12. When using a barcode reader, the first 12 characters of the bar code will be scanned to the ID dialog box. Last name Enter a number from 0 to 255. The default number is 0. First name Enter a number from 0 to 255. The default number is 0. Gender Enter a number from 0 to 255. The default number is 13.
SA Series Ambulatory Blood Pressure Monitor User Manual System Setting ABPM ID Set the name of local device. ABPM by default. EDP ID Set the name of GDT server. EDP by default. Encoding format Choose from ANSI, IBM437, and 7Bit. Export PDF file Create files as PDF when exporting GDT files. Disabled by default.
SA Series Ambulatory Blood Pressure Monitor User Manual Error Codes Chapter 10 Error Codes Error codes appears when abnormality occurs during the operation of ABPM. Error codes do not automatically indicate that a reading is invalid. They serve only as guides to help you use the ABPM.
SA Series Ambulatory Blood Pressure Monitor User Manual Er20 User Aborted User himself measurement.
SA Series Ambulatory Blood Pressure Monitor User Manual Cleaning, Care and Maintenance Chapter 11 Cleaning, Care and Maintenance Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. Edan Instruments has validated the cleaning and disinfection instructions provided in this User Manual.
SA Series Ambulatory Blood Pressure Monitor User Manual Cleaning, Care and Maintenance If the device or accessory has been in contact with the patient, then cleaning and disinfection is required after every use. If there has been no patient contact and there is no visible contamination then daily cleaning and disinfection is appropriate.
SA Series Ambulatory Blood Pressure Monitor User Manual Cleaning, Care and Maintenance Replacing the Air Bladder After cleaning, the bladder needs to be inserted back into the cuff sleeve so the pneumatic hose portion of the bladder goes through the tube opening on the cuff. Please note that the pneumatic hose connection should face upward when using the ABPM cuff on either the right of the left arm. CAUTION 1. Always close the Velcro strip before cleaning. 2.
SA Series Ambulatory Blood Pressure Monitor User Manual Cleaning, Care and Maintenance 11.3.1 Disinfecting the Monitor WARNING Before disinfecting the monitor, make sure that the monitor is powered off and disconnected from any power supply including batteries and USB connection. To disinfect the monitor, follow these steps: 1. Switch off the monitor. Take out the batteries or disconnect it from other power supply. 2. Disconnect the hose. 3.
SA Series Ambulatory Blood Pressure Monitor User Manual 6. Cleaning, Care and Maintenance Inspect the cuff sleeve, bladder, and hose to ensure that there is no damage. Replacing the Air Bladder After disinfection, the bladder needs to be inserted back into the cuff sleeve. Refer to section 11.2.2 for operation. NOTE: Prolonged use of disinfectant may cause discoloration of the cuff. 11.
SA Series Ambulatory Blood Pressure Monitor User Manual Cleaning, Care and Maintenance and the monitor cases for cracks, fraying, or kinks. Do not use the monitor or cuff if there are any signs of damage. Please contact our service department if any damage or defects are identified. 11.5.2 Calibration The accuracy of the ABPM should be checked at least once every year. If needed, an authorized service center may recalibrate the pressure transducers in the monitor.
SA Series Ambulatory Blood Pressure Monitor User Manual Cleaning, Care and Maintenance 1) PC and Monitor ♦ Avoid excessive temperature, sunshine, humidity and dirt. ♦ Put the dustproof coat on the monitor after use and prevent shaking it violently when moving it to another place. ♦ Prevent any liquid from seeping into the equipment; otherwise the safety and the performance of the monitor cannot be guaranteed. 2) Hose ♦ Integrity of the pneumatic hose should be checked regularly.
SA Series Ambulatory Blood Pressure Monitor User Manual Accessories Chapter 12 Accessories WARNING Only the cuff and other accessories supplied by the manufacturer can be used. Or else, the performance and electric shock protection cannot be guaranteed. Table 12-1 Accessory list Accessory Part Number Cuff sleeve (L) 01.57.472007 Cuff sleeve (M) 01.57.472006 Cuff sleeve (S) 01.57.472008 Cuff sleeve (XS) 01.57.472009 Carrying pouch 01.56.466767 Belt 01.56.465781 USB cable 01.13.
SA Series Ambulatory Blood Pressure Monitor User Manual Warranty and Service Chapter 13 Warranty and Service 13.1 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.
SA Series Ambulatory Blood Pressure Monitor User Manual Technical Specifications Appendix 1 Technical Specifications A1.
SA Series Ambulatory Blood Pressure Monitor User Manual Technical Specifications A1.2 Environment Specifications Transport & Storage Working -20ºC (-4ºF)~+55ºC (+131ºF) +5ºC (+41ºF) ~ +40ºC (+104ºF) Relative Humidity 15%RH~95%RH Non-Condensing 15%RH~95%RH Non-Condensing Atmospheric Pressure 70 kPa ~106 kPa 70 kPa ~106 kPa Temperature A1.3 Physical Specifications Dimensions 106.5 mm × 62 mm × 27 mm, ±1 mm Weight 160g ±10g (excluding battery and cuff) Display 0.96" screen A1.
SA Series Ambulatory Blood Pressure Monitor User Manual Technical Specifications Blood pressure: 1 mmHg (0.133kPa) Resolution Pulse: 1 bpm Over-pressure protection The cuff will be deflated when the measurement pressure reaches 297±3mmHg (39.6±0.4 kPa). Data memory Flash memory stores up to 300 readings.
SA Series Ambulatory Blood Pressure Monitor User Manual EMC Information Appendix 2 EMC Information Electromagnetic Emissions Guidance and manufacture’s declaration - electromagnetic emission The SA series device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
SA Series Ambulatory Blood Pressure Monitor User Manual Electrical fast 2 kV for power Not applicable transient/burst supply lines IEC/EN 61000-4-4 1kV for input/output lines Surge 1 kV line to line IEC/EN 61000-4-5 2 kV line to ground Power frequency 30A/m Not applicable 30A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
SA Series Ambulatory Blood Pressure Monitor User Manual EMC Information Electromagnetic Immunity Guidance and manufacture’s declaration - electromagnetic immunity The SA series device is intended for use in the electromagnetic environment specified below. The customer or the user of the SA series device should assure that it is used in such an environment.
SA Series Ambulatory Blood Pressure Monitor User Manual EMC Information recommended separation distance in meters (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.
SA Series Ambulatory Blood Pressure Monitor User Manual EMC Information Table 1 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Frequency (MHz) IMMUNITY Brand a) Service a) (MHz) Modulation Maximum Distance TEST b) Power(W) (m) LEVEL (V/m) Pulse 385 380-390 TETRA 400 modulationb) 1.8 0.3 27 2 0.3 28 0.2 0.3 9 2 0.3 28 2 0.3 28 2 0.3 28 0.2 0.
SA Series Ambulatory Blood Pressure Monitor User Manual EMC Information a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50% duty cycle square wave signal. c) As an alternative FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
SA Series Ambulatory Blood Pressure Monitor User Manual Appendix 3 Abbreviation Abbreviation Full Description BP Blood Pressure HR Heart Rate OLED Organic Light-Emitting Diode SYS Systolic Blood Pressure DIA Diastolic Blood Pressure AASI Ambulatory Arterial Stiffness Index ID Identification PDF Portable Document Format AC Alternating Current USB Universal Serial Bus NC Normal Condition SFC Single Fault Condition - 56 - Abbreviation
