Table of Contents
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Introduction to Ambulatory Blood Pressure Monitoring ............................................................ 2
Indication ......................................................................................................................................... 2
Package Contents .......................................................................................................................... 2
Intended Use ................................................................................................................................... 2
Contraindication .............................................................................................................................. 3
Warning ............................................................................................................................................ 3
Caution .............................................................................................................................................. 4
PARTS AND DISPLAY INDICATORS ......................................................................................... 5
SPECIFICATIONS .......................................................................................................................... 5
SET UP REQUIREMENTS ........................................................................................................... 6
BATTERY HANDLING AND USAGE ........................................................................................... 6
SET UP PROCEDURES ............................................................................................................... 7
ABPM SYNC AND SETUP ........................................................................................................... 7
MEASUREMENT PROCEDURES .............................................................................................. 8
TAKING YOUR BLOOD PRESSURE READING ...................................................................... 9
TAKING YOUR BLOOD PRESSURE READING MANUALLY ................................................ 9
TAKING YOUR BLOOD PRESSURE READING AUTOMATICALLY ................................... 10
BLOOD PRESSURE CLASSIFICATION FOR ADULTS ........................................................ 10
TROUBLESHOOTING ................................................................................................................ 10
CARE AND MAINTENANCE ...................................................................................................... 12
WARRANTY INFORMATION ..................................................................................................... 12
EXPLANATION OF SYMBOLS .................................................................................................. 12
IMPORTANT INFORMATION REQUIRED BY THE FCC ...................................................... 13
OTHER STANDARDS AND COMPLIANCES .......................................................................... 14
ELECTROMAGNETIC COMPATIBILITY INFORMATION ..................................................... 15
iHealth
Ambulatory Blood Pressure Monitor (ABP100)
Table of Contents
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CardioMed
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Summary of Contents for iHealth CardioMed
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Page 1: Table Of Contents
® iHealth CardioMed Ambulatory Blood Pressure Monitor (ABP100) USER GUIDE Table of Contents Introduction to Ambulatory Blood Pressure Monitoring ............2 Indication ............................2 Package Contents .......................... 2 Intended Use ........................... 2 Contraindication ..........................3 Warning ............................3 Caution .............................. 4 ... -
Page 2: User Guide
Introduction to Ambulatory Blood Pressure Monitoring Thank you for selecting the iHealth CardioMed Ambulatory Blood Pressure Monitoring. Ambulatory blood pressure monitoring (ABPM) is to allow subjects to wear an ambulatory blood pressure recording device for normal daily activities and sleep, the instrument will automatically set blood pressure measurements at intervals, recording 24h. -
Page 3: Contraindication
If an Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will be displayed in the iHealth APP. Under this condition, the Blood Pressure Monitor can keep functioning, but the results may be inaccurate. Please consult your physician for accurate assessment. -
Page 4: Caution
Whether applying the device to confused, dazed, unconscious or otherwise incapable patients need to consult a physician. The device should be used only under supervision if the physician agrees. Whether applying the device to the patients with serious mobility impairments need to consult a physician. The device should be used only under supervision if the physician agrees. -
Page 5: Parts And Display Indicators
Please do not share the cuff with any infectious person to avoid cross-infection. PARTS AND DISPLAY INDICATORS SPECIFICATIONS 1. Product name: iHealth CardioMed 2. Model: ABP100 3. Classification: Internally powered; Defibrillation-proof Type BF applied part; IP22, No AP or APG; Continuous operation 5 / 16 ... -
Page 6: Set Up Requirements
19. The blood pressure measurement system includes accessories: pump, valve, cuff, LED screen and sensor. Note: These specifications are subject to change without notice. SET UP REQUIREMENTS The iHealth CardioMed Ambulatory Blood Pressure Monitor is designed to be used with the following iPad models: iPad Air+ iPad mini+ iPad 3+ Please note that the compatible devices are subject to change. -
Page 7: Set Up Procedures
Battery life and charge cycles vary by use and settings. SET UP PROCEDURES Download the Free iHealth App Prior to first use, scan QR code and download the iHealth App. Follow the on-screen instructions to register and set up your personal account. Access the iHealth Cloud Account Your iHealth account also gives you access to the secure iHealth cloud service. -
Page 8: Measurement Procedures
Bluetooth connected Syncing Syncing Sync finished SYNC TIME AND SETTINGS Automatic mode is disabled before automatic test parameters are set. Using APP to configuration automatic mode parameters. Time and date on the device will be automatically sync with your smart device when the Bluetooth connection is established. -
Page 9: Taking Your Blood Pressure Reading
Right arm measurement TAKING YOUR BLOOD PRESSURE READING The iHealth CardioMed Ambulatory Blood Pressure Monitor has two measurement modes. Preparing your patient for the ABPM study is the most important step to achieving a successful test. TAKING YOUR BLOOD PRESSURE READING MANUALLY... -
Page 10: Taking Your Blood Pressure Reading Automatically
TAKING YOUR BLOOD PRESSURE READING AUTOMATICALLY Long press the for at least 2 seconds to switch on or off the "Automatic Mode", the monitor shows current automatic mode on the LED screen. If the monitor has no automatic mode parameters, the monitor shows "- -" on the LED monitor. - Page 11 LED display reads Fail to detect systolic pressure “Er1” LED display reads Fail to detect diastolic pressure “Er2” LED display reads Pneumatic system blocked or cuff “Er3” is too tight during inflation Apply the cuff correctly and try LED display reads Pneumatic system leakage or cuff again “Er4”...
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Page 12: Care And Maintenance
The warranty extends only to the end user. We will, at our option, repair or replace without charge the iHealth Next Blood Pressure Monitor covered by the warranty. Repair or replacement is our only responsibility and your only remedy under the warranty. -
Page 13: Important Information Required By The Fcc
(1) This device may not cause harmful interference, and this device must accept any interference received, including interference that may cause undesired operation. (2) Changes or modifications not expressly approved by iHealth Lab Inc. would void the user’s authority to operate the product. -
Page 14: Other Standards And Compliances
The full text of the EU declaration of conformity is available at the following internet address: www.ihealthlabs.eu OTHER STANDARDS AND COMPLIANCES The iHealth CardioMed Ambulatory Blood Pressure Monitor corresponds to the following standards: IEC 60601-1Edition 3.1 2012-08/EN 60601-1:2006/A1:2013 (Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance);... -
Page 15: Electromagnetic Compatibility Information
ISO81060-2 ：2013,(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type). ELECTROMAGNETIC COMPATIBILITY INFORMATION This product is applicable to the equipment and system requirements for the purpose of receiving radio frequency energy for the purpose of the work, Bluetooth receive bandwidth 2M. This product can also be used to include RF transmitter equipment and system requirements and emission frequency of 2.4GHz ISM band, Bluetooth modulation types:GFSK, effective radiated power: <4dBm. - Page 16 1720 1700-1990 Pulse modulation 217Hz, 28V/m 1845 1970 2450 2400-2570 Pulse modulation 217Hz, 28V/m 5240 5100-5800 Pulse modulation 217Hz, 9V/m 5500 5785 Table 4 – Input a.c. power Port Phenomenon Basic Immunity test levels standard Home Healthcare Environment Electrical fast IEC 61000-4-4 ±2 kV transients/burst...
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