iHealth TM Wireless Blood Pressure Monitor (BP5) OWNER’S MANUAL Table of Contents INTRODUCTION PACKAGE CONTENTS INTENDED USE BLOOD PRESSURE CLASSIFICATION FOR ADULTS CONTRAINDICATION PARTS AND DISPLAY INDICATORS SET UP REQUIREMENTS SET UP PROCEDURES MEASUREMENT PROCEDURES SPECIFICATIONS GENERAL SAFETY AND PRECAUTIONS BATTERY HANDLING AND USAGE TROUBLESHOOTING 1 1 1 1 2 2 2 3 4 6 7 8 9 CARE AND MAINTENANCE WARRANTY INFORMATION EXPLANATION OF SYMBOLS IMPORTANT INFORMATION REQUIRED BY THE FCC OTHER STANDAR
INTRODUCTION BLOOD PRESSURE CLASSIFICATION FOR ADULTS Thank you for selecting the iHealth Wireless Blood Pressure Monitor. The iHealth Wireless Blood Pressure Monitor is a fully automatic arm cuff blood pressure monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your iOS devices to test, track and share vital blood pressure data.
PARTS AND DISPLAY INDICATORS SET UP PROCEDURES Status indicator Bluetooth indicator START/STOP button Download the Free iHealth APP Prior to first use, download and install the iHealth App from the App Store. Use keyword search terms “iHealth”, “BP5” or ”BPM”. Connect to iOS Device Via Bluetooth Cuff • Apply the cuff or press the START/STOP button, the Bluetooth Indicator Light will begin flashing.
MEASUREMENT PROCEDURES Body Posture Apply the Cuff 1/2”(1-2cm) FF h /O N O lt ea 5 iH a. Pull the cuff end through the metal loop, positioning it outward (away from your body). b. Place a bare arm through the cuff and position the cuff 1/2”(1-2cm) above the elbow joint. c. Tighten the cuff and close it by pulling it towards your body, securing it closed with the Velcro fastener. d. While seated, place your hand palm-side up in front of you on a flat surface such as a desk or table.
Monitor Status Bluetooth Indicator During measurement, press the “START/STOP” button to stop the measurement process. Waiting to connect Flashing blue light Measuring Steady blue light Important: Please consult a healthcare professional for interpretation of blood pressure measurements. Measurement completed Gradually extinguishing light Operation Instructions With iOS Device For detailed operating instructions, please visit http://www.ihealthlabs.com.
11. Accuracy: Pressure: ±3 mmHg Pulse rate: ±5% 12. Wireless communication: Bluetooth V3.0 + EDR Class 2 SPP Frequency Band: 2.402-2.480 GHz 13. Environmental temperature for operation: 5°C~40°C(41°F~104°F) 14. Environmental humidity for operation: ≤90%RH 15. Environmental temperature for storage and transport: -20°C~55°C(-4°F~131°F) 16. Environmental humidity for storage and transport: ≤95%RH 17. Environmental pressure: 80kPa-105kPa 18. Battery life: more than 80 measurements on a full charge 19.
result in measurement errors and a biocompatible hazard. ! This product might not meet its performance specifications if stored or used outside the specified temperature and humidity ranges. 11. ! Please do not share the cuff with any infectious person to avoid cross-infection. 12. This product should not be used as a USB device. 13. This product is verified by auscultatory method. It is recommended that you check Annex B of ANSI/AAMI SP-10:2002+A1:2003+A2:2006 for verification method details if needed. 14.
CARE AND MAINTENANCE TROUBLESHOOTING PROBLEM POSSIBLE CAUSE SOLUTION Low Battery Battery is less than 20% Charge the battery Blood pressure is outside of measurement range Retest, make sure your blood pressure is within measurement range Arm or monitor was moved during test Retest, make sure not to move your arm or the monitor The cuff does not inflate properly or pressure falls quickly during test Review the cuff application instructions and retest Irregular heartbeat (arrhythmia) It is inapp
12. It is recommended that if the cuff is used, for example, in a hospital or a clinic, it be disinfected twice a week. Wipe the inner side (the side that contacts skin) of the cuff with a soft cloth lightly moistened with Ethyl alcohol (75-90%). Then air dry the cuff.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by iHealth Lab Inc. is under license. Other trademarks and trade names are those of their respective owners. Manufactured for iHealth Lab Inc. 719 N. Shoreline Blvd., Mountain View, CA 94043, USA 1-855-816-7705 www.ihealthlabs.com Lotus Global Co., Ltd. 15 Alexandra Road, London UK, NW8 0DP Tel: +0044-20-75868010 Fax: +0044-20-79006187 EC REP ANDON HEALTH CO., LTD. No.
OTHER STANDARDS AND COMPLIANCES ELECTROMAGNETIC COMPATIBILITY INFORMATION The Wireless Blood Pressure Monitor corresponds to the following standards: IEC 60601-1:2006 (Medical electrical equipment – Part 1: General requirements for safety); IEC 60601-1-2:2007 (Medical electrical equipment – Part 1: General requirements for safety; Collateral Standard-Electromagnetic compatibility - Requirements and tests); EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive sphygmomanometers - Part 1: General requirements
Table 2 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration - electromagnetic immunity The Wireless Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Wireless Blood Pressure Monitor should assure that it is used in such an environment.
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. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
