SAFETY INFORMATION Symbol Description The Operation Guide Must be Read Serial Number Manufacturer Direct Current Manufacture Date Type B Applied Parts ENVIRONMENT PROTECTION - Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice. Caution COR1 LCD DISPLAY Symbol Description Explanation Systolic Blood Pressure High Pressure Result Diastolic Blood Pressure Low Pressure Result BPM Heart Beats per Minute Memory See Page 14 Movement Error Results in Inaccurate Measurement Low Battery Replace Batteries kPa Measurement Unit 1kPa=7.5mmHG mmHg Measurement Unit 1mmHg=0.133kPa Deflating Cuff is Deflating Current Time YY:MM::DD, HH:MM Grade Grade of Blood Pressure Arrhythmia Irregular Heartbeat Heartbeat Heartbeat Detection During Measurement N Memory Hype. G3 G2 G1 Norm. Pul/min Hypo. Time/Date Hypo. Systolic Diastolic press relax blood discharging artery blood entering vein Blood Pressure Category Normal Systolic mm Hg (upper #) Diastolic mm Hg (lower #) less than 120 and less than 80 Pr-hypertensive 120-139 or 80-89 High Blood Pressure Stage 1 (Hypertension) 140-159 or 90-99 High Blood Pressure Stage 2 (Hypertension) 160 or higher or 100 or higher Higher than 180 or Higher than 110 (Hypertension) Stage 1 (Hypertension) Stage 2 Hypertensive Crisis (Emergency Care Needed) (Emergency Care Needed) SYS 135 mm Hg DIA 85 mm Hg PROBLEM No Power Low Batteries Error Message SYMPTOM Display is dim or will not light up. + Lo Shown on the display CHECK THIS REMEDY Batteries are exhausted Replace with new batteries Batteries are inserted incorrectly Insert batteries correctly Low Battery Replace with new batteries E1 Shows The cuff is not secure Refasten the cuff and then measure again E2 Shows The cuff is too tight Refasten the cuff and then measure again E3 Shows The pressure of the cuff is excessive Relax for a moment then measure again E10 or E11 Shows The monitor detected motion while measuring. Movement can affect the measurement. Relax then measure again. E20 Shows The measurement process does not detect the pulse signal. Loosen clothing on the arm and them measure again. E21 Shows Measure incorrectly Relax for a moment and then measure again A calibration error occurred. Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance. Refer to the warranty for contact information and return instructions. EExx,shows on the display. Power supply 2*AAA alkaline batteries (3V) Display mode Digital LCD V.A 44×31.5mm Measurement mode Oscillographic testing mode Measurement range Pressure: 0kpa - 40kpa (0mmHg-300mmHg) Pulse value: 40 - 199 beats / minute Accuracy Pressure: ±3mmHg (≥ 200 mmHg,2%) pulse value:±5% Normal working condition Temperature: 41°F - 104°F Relative humidity ≤85% Atmospheric Pressure: 86kPa to 105kPa Storage & transportation condition Temperature:-24.8°F to 131°F Temperature:-20°C to 55°C Relative humidity: ≤ 90%RH Measurement perimeter of the wrist Approximately 5.3 in - 8.4 in Approximately 13.5 cm - 21.5 cm Weight Approximately 4.23 oz (Excluding the dry cells) External dimensions Approx. 2.6 in x 2.9 in x 1.2 in (68 mm ×75 mm ×31mm) Attachment 2*AAA batteries; user manual Mode of operation Continuous operation Degree of protection Type B applied part IP Classification IPX0 Software version V01 Device classification Internally powered ME Equipment Risk Management ISO 14971:2012 Medical devices — Application of risk management to medical devices. Labeling ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labeling and information to be supplied. General requirements User manual EN 1041: 2008 Medical equipment manufacturers to provide information General Requirements for Safety IEC 60601-1: 2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Electromagnetic compatibility IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests Performance and clinical requirements ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or automated Software life-cycle processes IEC 62304:2006+AC: 2008 Medical device software - Software life cycle processes Guidance and manufacturer’s declaration - electromagnetic emission The 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. Emissions test Compliance Electromagnetic environment - guidance RF Emissions - CISPR 11 Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF Emissions - CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Not Applicable Voltage Fluctuations / Flicker Emissions IEC 61000-3-3 Not Applicable Recommended separation distances between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter (m) Rated maximum output power of transmitter (W) 150 kHz to 3,580 MHz d=[ V1 ] P 80 MHz to 800 MHz d = 1.167 P 800 MHz to 2.5 GHz d = 2.333 P 0.01 Not Applicable 0.117 0.233 0.1 Not Applicable 0.369 0.738 1 Not Applicable 1.167 2.333 10 Not Applicable 3.690 7.378 100 Not Applicable 11.67 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80MHz and 800MHz, the separation distance for 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. Guidance and manufacturer’s declaration - electromagnetic immunity The 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 Immunity Test IEC 6060 1 Test Level Compliance Level Electromagnetic environment - guidance Electrostatic discharge (ES D) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be `at least 30%. Electrical fast transient / burst IEC 61000-4-4 ±2 kV for power supply lines N/A Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1 kV line(s) to line(s) ±2 kV line(s) to earth N/A Mains power quality should be that of a typical commercial or hospital environment. <5% UT (>95% dip in the UT) for 0.5 cycles N/A 40% UT (60% dip in the UT) for 5 cycles N/A 70% UT (30% dip in the UT) for 25 cycles N/A <5% UT (>95% dip in the UT) for 5 cycles N/A 3 A/m 3 A/m Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power Frequency (50Hz) magnetic field IEC 61000-4-8 Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered by an uninterrupted power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note: UT is the a.c. mains voltage prior to application of the test level Guidance and manufacturer’s declaration - electromagnetic immunity The 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. Immunity Test IEC 6060 1 Test Level Compliance Level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz d=[ Not applicable 3 V/m 3,5 V1 ] P d = 1.167 P 80 MHz to 800 MHz d = 2.333 P 800 MHz to 2,5 G Hz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 NOTE 2 At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broad-cast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [ ]V/m.