BloodPressureMonitor Model:DB68 User Manual Rev.00 2019/03/14 Thank you for purchasing TRULY Blood Pressure Monitor. Please read through this "Users Manual" before using the product. 1/15 Contents 1. Identification For Use ----------------------------------------------------------3 2. Safety Precautions -----------------------------------------------------------3 3. Quick start Guide 3.1 Monitor -------------------------------------------------------------5 3.2 Battery Installation ----------------------------------------------------------6 4. Taking Measurement 4.1 Sitting Correctly ------------------------------------------------------------6 4.2 Applying the Arm Cuff --------------------------------------------------------7 4.3 Taking measurement ---------------------------------------------------------7 4.4 Heartbeat Readings ----------------------------------------------------------7 5. Memory Functions 5.1 View Past Readings ----------------------------------------------------------8 5.2 Delete Past Readings --------------------------------------------------------8 6. Troubleshooting -----------------------------------------------------------8 7. Storage & Maintenance ------------------------------------------------------------9 8. Product Specifications ------------------------------------------------------------9 9. EMC Declaration ------------------------------------------------------------10 10. Disposal ------------------------------------------------------------14 11.FCC Statement ------------------------------------------------------------14 2/15 1. Identification For use Truly Automatic Arm Blood Pressure Monitor intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication . The devices are intended to use of Over-The-Counter 2. Safety Precautions Caution The monitor uses the oscillometric method to measure systolic and diastolic blood pressure, as well as heart rate
- This device is intended for use in measuring blood pressure and pulse rate in the adult population, do not use this device on infants or persons who cannot express their intentions: The monitor is not intended to be a diagnostic device, It is a home healthcare product only and it is not intended to serve as a substitute for the advice of a physician or medical professional
- Don't not use this device for diagnosis or treatment of any health problem or disease, Measurement results are for reference only, consult a healthcare professional for interpretation of pressure measurements, Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or healthcare professional
- Use only Truly authorized parts and accessories Parts and accessories not approved for use with the device may damage the unit and get a error of measurementThere are no replaceable parts (such as sensors, electrode pads, etc.). Do not disassemble or repair or modify the ME EQUIPMENT, it will get a error of measurement If you need to repair, please contact the dealer and repair it.
- Proper cuff size is critical for accurate measurements Follow the instructions in this manual and printed on the arm cuff to ensure the appropriate size of cuff is being used
- Blood pressure measurement can be affected by the other factors; Position of the user such as bending over the body or cross-legged sitting will produce abdominal pressure or make the position of the arm below the heart, that will increase the blood pressure
This product is not suitable for people with arrhythmias or serious arteriosclerosis. It may have difficulty determining the proper blood pressure for pregnant women and for users with irregular heartbeat, diabetes, pre-eclampsia, poor circulation of blood, measurement on the arm on the side of a mastectomy,kidney problems or for users who have suffered from a stroke
- When measurement, The pressurization of the cuff to arm where intravascular access or the rapy,or an arterio-venous(A-V) shunt,is present because of temporary interference to blood flow and could result in injury to the patient 3/15
- When measurement, The pressurization of the cuff can temporarily cause function of simultaneously used monitoring other device on the same limb
- The pulse display is not suitable for checking the frequency of heart pacemakers
- Do not use a cellular phone near the device, It may result In an operational failure
- Do not use the monitor in the driving or flying vehicles
- Frequenly measuring will make the blood not flow, cause the arm-numbness and abnormal reaction of body When you are using the monitor to measure especially frequently used, the arm is compressed by the cuff, and then the fingertip will be caused congestion. During the congestion, please loosen the cuff and lift the hands over your head, and make your right and left hand squeese and stretch 15 times, them will unclog the congestion Do not applying the CUFF over a wound, as this can cause further injury
- When measurement, please check that operation of the device does not result in prolonged impairment of the circulation of the blood of the patient
- Do not compress the cuff tube during the measurement, or it will cause fail inflation or affect the result of measurement
- Please use the product in the approved operate environment, the time required for the ME EQUIPMENT to warm from the minimum storage temperature is two hoursthe time required for the ME EQUIPMENT to cool from the maximum storage temperature is two hoursor will cause the inaccurate result of Handling batteries properly:
measurement
- Handling batteries properly: measurement
As soon as old batteries run out, replace with newbatteries,
Do not use old and new batteries together
Align the polarities of batteries correctly;
When the unit will not be used for more than 3 months,remove the batteries,Ohterwise, batteries may leak and cause damage to the unit
- Dispose of the device,components and optional ,accessories according to applicable local regulation,Unlawful disposal may cause environmental pollution
- Dont calling around the Blood pressure monitor when it is using ,Dont move and avokd electromagnetic interference and noise interference when measuring that to avoid to measure error
- When the screen display the battery for one degree,it means that low Voltage and must change the new one to void to measure error
- Babies, young children or individuals who cannot express their consent are not suitable to take blood pressure measurement.
- Keep the equipment away from children and pets.
- Blood pressure readings may change in case of pregnancy. Pregnant women can consult their doctor before taking measurement Individuals with serious arteriosclerosis are not suitable to take blood pressure measurement
- Self-measurement is not medical treatment lf there are unusual values, please consult your doctor 4/15
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s wrong?
Solution Replace n Re-align new batter batteries ies. in correct 8/15 Er P displayed Fail to inflate Er 1 displayed Er 2 displayed Deflate too rapidly Movement during measurement Do Signal interference polarities. Check if the cuff is properly connected.Replace the air tube if it is broken. Return for servicing. not move during measurement Remove interfering source e,g. mobile phones,magnets. Measure again Incorrect results Er 3 displayed Note: If your problem cannot be solved by the above,consult your store of purchase.Do not disassemble the unit. 7. Storage & Maintenance
Keep away the unit from direct sunlight,extreme temperatures,humidity or moisture.
Use a dry,soft cloth to clean the unit,or if desired,use a cloth lightly dampened with water.
Do not use alcohol,benzene,thinner or other volatile liquids to clean the unit.
Do not wash or expose the arm cuff to liquid.
The user must check that the equipment functions safely and see that it is in proper working condition before being used. WARNING: long power cable and air hose.To avoid strangulation and entanglement,keep cable and hoses out of reach of young children. 8. Product Specifications Model No. Measurement method Measurement range Accuracy Inflation DB68 Oscillometric Pressure:20~280 mmHg Pulse Rate:40~195 beats/min Pressure: 3 mmHg Pulse Rate: 5%
Pump driven Pressure Detection Semi-conductor Power Supply 4x AA batteries 9/15 Auto power off 3 minute after not being used The pressure of the running 70KPa~106KPa Storage Environment.
-20~60,10%~95%RH Operating Environment. 10~40,30%~85%RH Dimensions 1249552mm Net Weight Used Life Span of Battery Software version Use Period Application part Cuff Dimensions 236g ( batteries excluded) 1000 times 5 year Out of contact the body,:onnect tubshell contact the body :cuff For arm circumference of 22~34cm(Special size to be ordered separately) Cuff ,Instruction Manual,Battery Set ,Warrant Card Package Content Note:Subject to modification without prior notice. 9. EMCDeclaration Guidance and manufacturers declaration electromagnetic immunity The XXX is intended for use in the electromagnetic environment specified below. The customer or the user of the XXX should ensure that it is used in such an environment. Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 IEC 60601 test level 6 kV contact 8 kV air Compliance level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines 1 kV for input/output lines Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment. 10/15
<5 % UT
(>95 % dip in UT) for 0,5 cycle 40 % UT
(60 % dip in UT) for 5 cycles 70 % UT
(30 % dip in UT) for 25 cycles
<5 % UT
(>95 % dip in UT) for 5 sec
<5 % UT
(>95 % dip in UT) for 0,5 cycle 40 % UT
(60 % dip in UT) for 5 cycles 70 % UT
(30 % dip in UT) for 25 cycles
<5 % UT
(>95 % dip in UT) for 5 sec 3 A/m 3 A/m Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of the test level. Mains power quality should be that of a typical commercial or hospital environment. If the user of the XXX requires continued operation during power mains interruptions, it is recommended that the XXX be powered from an uninterruptible 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. 11/15 EMCDeclaration
(Continued) Guidance and manufacturers declaration electromagnetic immunity The XXX is intended for use in the electromagnetic environment specified below. The customer or the user of the XXX should ensure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance 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 communications and mobile RF Portable equipment should be used no closer to any part of the XXX, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 3 V d=1.2P d=1.2P 80MHz to 800MHz d=2.3 P 800MHz to 2.5 GHz 3 V/m is the where Pis the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d recommended separation distance in metres (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. 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 broadcast 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 XXX is used exceeds the applicable RF compliance level above, the Medical XXX should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the XXX. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. 12/15 a b EMCDeclaration Guidance and manufacturers declaration electromagnetic emissions The XXX is intended for use in the electromagnetic environment specified below. The customer or the user of the XXX should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Group 1 Class B Class A Complies The XXX 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. The XXX is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Recommended separation distances between portable and mobile RF communications equipment and the Medical XXX The XXX is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Medical XXX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the XXX as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output power of transmitter W 0,01 0,1 1 10 100 150 kHz to 80 MHz 0.12 0.38 1.2 3.8 12 m 80 MHz to 800 MHz 800 MHz to 2,5 GHz 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 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 Pis the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, 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. 13/15 11. Disposal At the end of its use don't dispose the appliance, including removable parts and Accessories, together with the other urban waste, but conformably to 2002/96/EC. Since to be treated apart from home waste, you must take it to a differential collection centre specific for electric and electronic equipment. Otherwise you can give it back to the retailer as you buy an equivalent apparatus. There will be Server sanctions in case of transgression The batteries used in this device must be disposed of in the special bins at the end of their life 12. FCC Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user Is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This device complies with Part 15 of FCC Rules. Operation is subject the following two conditions:
(1) This device may not cause harmful interference, and (2)This device must accept any interference received, including interference that may cause undesired operation. Information to user Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Note: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment such modifications could void the user's authority, to operate this equipment. 14/15 15/15