EDAN INSTRUMENTS SA Series User Manual
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EDAN INSTRUMENTS SA Series User Manual

Ambulatory blood pressure monitors
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Summary of Contents for EDAN INSTRUMENTS SA Series

  • Page 2 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.
  • Page 3 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.

  • Page 4: Table Of Contents

    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 ...................... 1 1.2.2 Protecting Personal Information ................4 1.2.3 Battery Care Warnings ....................6 1.2.4 General Cautions .......................
  • Page 5 9.1 General Setting ........................30 9.2 Patient Information Setting ....................30 9.3 Security Setting ......................... 31 9.4 Communications Setting ....................31 9.5 Report Setting ........................32 9.6 Barcode Setting ......................... 32 9.7 GDT ..........................33 Chapter 10 Error Codes ......................35 Chapter 11 Cleaning, Care and Maintenance ................

  • Page 6: Chapter 1 Safety Guidance

    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 (>...
  • Page 7 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.
  • Page 8 27. Prevent babies or children from swallowing small components, e.g. the batteries. 28. SA series ABPM are precision instruments. Prevent babies or children from playing them. 29. The equipment should not be used adjacent to or stacked with other equipment, refer to the recommended separation distances provided in Appendix 2 EMC Information.

  • Page 9: Protecting Personal Information

    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. This device complies with Part 15 of the FCC Rules. Operation is subject to the...
  • Page 10 SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance To ensure the patients’ safety and protect their personal health information, the user should implement practices or measures that include: 1. Physical safeguards - physical safety measures to ensure that unauthorized personnel do not have access to the ABPM.

  • Page 11: Battery Care Warnings

    SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance Close the default services of remote desktop, Telnet, file sharing of Windows. It is recommended that you disable the Administrator and Guest accounts. Destroy the sensitive information in the idle or scrapped device.

  • Page 12: Contraindications

    Do not use on patients with erratic, accelerated or mechanically controlled irregular heart rhythms, including patient with arrhythmias. Due to the strangulation risk posed by the cuff and hose, the SA series ABPM must not be within reach of unsupervised children, and must not be used on unsupervised patients with limited cognitive abilities.

  • Page 13: List Of Symbols

    SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance 1.3 List of Symbols Symbol Description DEFIBRILLATION-PROOF TYPE BF APPLIED PART USB socket On/Off button Start/Stop button Protected against solid foreign objects of 12.5 mm Ø and greater IP 22...
  • Page 14 SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance AUTHORISED REPRESENTATIVE EUROPEAN COMMUNITY CE marking Disposal method Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. Refer to instruction manual/booklet (Background: Blue; Symbol: White) General warning sign (Background: Yellow;...
  • Page 15 SA Series Ambulatory Blood Pressure Monitor User Manual Safety Guidance Front Federal Communications Commission: FCC ID: SMQSAEDAN FCC ID: SMQSAEDAN NOTE: The user manual is printed in black and white. - 10 -...

  • Page 16: Chapter 2 Introduction

    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.

  • Page 17: Abp Monitor At A Glance

    SA Series Ambulatory Blood Pressure Monitor User Manual Introduction 2.2 ABP Monitor at a Glance OLED screen Displaying time, automatic or manual BP readings. Hose To connect the extension hose from the cuff to connection monitor for an ambulatory BP study.
  • Page 18 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.

  • Page 19: Chapter 3 Setting Up Abpm

    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.

  • Page 20: Connecting The Monitor To Pc

    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.
  • Page 21 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. - 16 -...

  • Page 22: Chapter 4 Main Screen Of Analysis Software

    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).
  • Page 23 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.

  • Page 24: Chapter 5 Conducting An Ambulatory Bp Study

    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.

  • Page 25: Fitting Patient With The Monitor And Cuff

    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.
  • Page 26 SA Series Ambulatory Blood Pressure Monitor User Manual Conducting an Ambulatory BP Study Cuff sleeve 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.

  • Page 27: Preparing The Patient

    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.

  • Page 28: Starting The Study

    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.

  • Page 29: Chapter 6 Retrieving Abp Data

    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.

  • Page 30: Chapter 7 Analyzing And Editing Abp Data

    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.
  • Page 31 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.

  • Page 32: Correlation

    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.

  • Page 33: Statistics

    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.

  • Page 34: Chapter 8 Creating Reports

    To save the report as a PDF, click the PDF tab. The system creates the PDF and saves the file to the location you specify. SA series provides you with flexibility in printing the report. You can either:  Print the configured report by clicking the Print tab. The Print dialog box is displayed where you can choose the preferred printer.

  • Page 35: Chapter 9 System 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.

  • Page 36: Security Setting

    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.

  • Page 37: Report Setting

    SA Series Ambulatory Blood Pressure Monitor User Manual System Setting 9.5 Report Setting You can configure or customize your report. Item Description You can enter up to 40 characters. After setting, the name is displayed on Hospital name the printed report.

  • Page 38: Gdt

    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.
  • Page 39 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.

  • Page 40: Chapter 10 Error Codes

    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.
  • Page 41 SA Series Ambulatory Blood Pressure Monitor User Manual Error Codes Er20 User Aborted User himself stopped measurement. - 36 -...

  • Page 42: Chapter 11 Cleaning, Care And Maintenance

    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. It is the responsibility of the healthcare professional to ensure that the instructions are followed so as to ensure adequate cleaning and disinfection.

  • Page 43: Cleaning The Monitor And Carrying Pouch

    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.

  • Page 44: Disinfection

    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.
  • Page 45 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.

  • Page 46: Care And Maintenance

    SA Series Ambulatory Blood Pressure Monitor User Manual 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.
  • Page 47 ± 3 mmHg. If it is not, the monitor needs to be returned to the service department for recalibration or repair. NOTE: To return the SA series ABPM to its normal operating mode, power off and on the monitor.
  • Page 48 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.

  • Page 49: Chapter 12 Accessories

    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...

  • Page 50: Chapter 13 Warranty And Service

    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.

  • Page 51: Appendix 1 Technical Specifications

    SA Series Ambulatory Blood Pressure Monitor User Manual Technical Specifications Appendix 1 Technical Specifications A1.1 Safety Specifications IEC 60601-1:2005+A1:2012 EN 60601-1:2006+A1:2013 IEC 60601-1-2:2014 Comply with EN 60601-1-2:2015 EN/IEC 60601-1-11 EN/ISO 80601-2-30 EN/ISO 81060-2 Anti-electric-shock type Internally powered equipment Anti-electric-shock degree...

  • Page 52: A1.2 Environment Specifications

    SA Series Ambulatory Blood Pressure Monitor User Manual Technical Specifications A1.2 Environment Specifications Transport & Storage Working Temperature -20º C (-4º F)~+55º C (+131º F) +5º C (+41º F) ~ +40º C (+104º F) 15%RH~95%RH 15%RH~95%RH Relative Humidity Non-Condensing Non-Condensing...

  • Page 53: A1.6 Configuration Difference

    SA Series Ambulatory Blood Pressure Monitor User Manual Technical Specifications Blood pressure: 1 mmHg (0.133kPa) Resolution Pulse: 1 bpm The cuff will be deflated when the measurement pressure Over-pressure protection reaches 297±3mmHg (39.6±0.4 kPa). Data memory Flash memory stores up to 300 readings.

  • Page 54: Appendix 2 Emc Information

    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.
  • Page 55 SA Series Ambulatory Blood Pressure Monitor User Manual EMC Information 2 kV for power Electrical fast Not applicable Not applicable transient/burst supply lines 1kV for input/output IEC/EN 61000-4-4 lines 1 kV line to line Surge Not applicable Not applicable 2 kV line to ground...
  • Page 56 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.
  • Page 57 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SA series device is used exceeds the applicable RF compliance level above, the SA series device should be observed to verify normal operation.
  • Page 58 SA Series Ambulatory Blood Pressure Monitor User Manual EMC Information Table 1 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment IMMUNITY Test Brand Modulation Maximum Distance TEST Frequency Service (MHz) Power(W) LEVEL (MHz) (V/m) Pulse 380-390 TETRA 400...
  • Page 59 The SA series device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SA series device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SA series device as recommended below, according to the maximum output power of the communications equipment.

  • Page 60: Appendix 3 Abbreviation

    SA Series Ambulatory Blood Pressure Monitor User Manual Abbreviation Appendix 3 Abbreviation Abbreviation Full Description Blood Pressure Heart Rate OLED Organic Light-Emitting Diode Systolic Blood Pressure Diastolic Blood Pressure AASI Ambulatory Arterial Stiffness Index Identification Portable Document Format Alternating Current...

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