User manual

FCC ID: 2ABG7-DB68

Users Manual

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FCCID_4233902

Blood Pressure Monitor Model:DB68 User Manual Rev.00 2019/03/14 Thank you for purchasing TRULY Blood Pressure Monitor. Please read through this "User’s 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 measurement。There 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 hours；the time required for the ME EQUIPMENT to cool from the maximum storage temperature is two hours；or 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。 - Don’t calling around the Blood pressure monitor when it is using ,Don’t 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

¾ Hand dling batteries properrly „ lithium-lon batteries are a subjectt to disposa al and Reccycling regulations that vary by c country annd region.AAlways che eck and fo ollow your applicable e regulations before d disposing o any batte of ery contacct recharge eable battery recycling corporattion。 „ Do D not disa assemble,C Crush,or puncture a battery. „ Do D not sho ort the exte ernal contacts on a ba attery. „ Do D not disp pose of a battery b in fiire or wate er. „ Keep K the battery b awaay from chiildren. „ Do D not use e a damage ed battery. 3. Quic ck Start Guide G Attention：Don't disassem d ble,repairr and reno ovation ontology。 Connectt AC Adap ptor (optio onal) a． If you havee the AC adaptor,Plu a ug it into the AC addaptor jacck at the top t of the deevice.Remove batterries when using u the AC A adaptorr. b． Pllug the AC C adaptor in nto a DC6V V/1000mA outlet. Adapter: Input:100-240Va.c. 0.35A;;Output: 6.0Vd d.c. 1.0A 3.1 Monitor Featuress z One touch ope eration z Backklight and large size LCD L z 99 To otal Memoory z Bluetooth 4.0 z Averraging mod de-the ave erage valu ue of the last l 3 meaasurementts stored in the memmory will dissplay z Auto o –off powe er saving fe eature z Operrated by 4 AA batteriees Display 5 / 15

Package e Contents s 3.2 Batttery Insta allation 1 Pull and a lift on the t lock to remove th he battery cover. c 2 Remo ove the ussed batterie es and inse ert new batteries into the battery b com mpartmentt an shown n,taking carre that the polarities(+ p +) and (-) match m the polarities p of the ba attery comp partment as a indicatedd. 3 Repla ace the ba attery coverr. Press it lightly until u ock securrely clicks into place the lo e. Note:Re eplace battteries whe en the batttery indicator shows low voltage. --Avoid smoking s , ,eating or exercising for 30 minutes m be efore takin ng measurrement. -- Do not move orr talk durin ng measurrement. -- Measu urement can be take en on eith her arm. 4 Taking meas suremen nt 4.1 Sittting Correectly 1 Relaxx 2 Sit up pright in a chair with your both feet f on the e floor. 3 Remo ove tight fitting clothing from yo ou upper arm and thick cloth hing .Do no ot roll up yo our sleeve if it is too tight。 t 4 Placee your arm on a table e so that thhe cuff will be at the sam me level as your heartt. 6 / 15

4.2 Applying the e Arm Cufff 1 Place e your elbo ow on a tabble and palm facing upward,and u d wrap the arm cuff around a the upper lefft arm. 2 Pull ono the end d of the cufff until it wraps w securely around d your upp per arm.Do o not over tighten th he cuff .Allow 1~2 cmm or ½ incch between n the botto om of the ccuff and yo our elbow joint. 3 Make e sure the cuff c is at thhe same le evel as you ur heart. Note: --Proper cuff size is critical for accura ate measu urements.FFollow the instructions is this manual and a printed d on the arrm cuff to ensure e the appropriatte size of ccuff is being used. --This monitor m co omes with h a stand dard size arm cufff that fitss arms 8.7″~13.4″ 8 （22cm~ ~34cm）. --Position n cuff edgee 0.4~0.8 inches(1~2 2cm)abovee elbow. 4.3 Tak king Meassurement 1 Presss the “⊙”b button.the cuff c will auttomatically y inflate and the meassurement will w start. 2 When the measurementt is comp plete,the cuff will au utomaticallyy deflate and your systolic and a diastollic pressurre values and a pulse rate r will dissplay. 3 Remo ove the arm m cuff and take note of your meeasuremen nt results. 4.4 Hearrtbeat Rea adings 7 / 15

5 . Mem mory Fun nctions After meeasuremen nt,the last set of measured values v will be savedd automaticcally after measure ement when the unit is i turned off o by press sing “⊙”bu utton or by automatic power off after 3 minutes. m 5.1 Vie ew Past Re eadings 1 Presss the “MEM M”button too enter memory functtion, 2 Presss the “MEM M”button too display thhe next setts of valuees.Past reaadings are displayed from the most rece ent to the oldest. o 3 This can c stored d up to 99 sets s of passt readings s. 5.2 Dellete Past Readings R When the monitor’’s power iss off,press and hold the memo ory button”MEM”for 5 seconds until the e memory icon “ⓜ”appears in the display .Witthout rele easing the memory button,prress the po ower button“⊙” and “EE EE” will w appear.R Release thhe power button b “⊙” and the memory m button.”MEEM” to erasse all store ed readingss from the monitor. 6. Troubleshoo oting Problem Cau use Solution No display when you Havve the batte eries run out? o Replace nnew batteries. press the e Power /S Start Are the batteryy polarities s wrong? Re-align batteries in correct button 8 / 15

polarities. “Er P” displayed Fail to inflate Check if the cuff is properly connected.Replace the air tube if it is broken. “Er 1” displayed Deflate too rapidly Return for servicing. “Er 2” displayed Movement during measurement Do not move during measurement Signal interference Remove interfering source e,g. mobile phones,magnets. “Er 3” displayed Incorrect results Measure again 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. DB68 Measurement method Oscillometric Measurement range Pressure:20~280 mmHg Pulse Rate:40~195 beats/min Accuracy Pressure: ±3 mmHg Pulse Rate: ±5% Inflation 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 124×95×52mm Net Weight 236g ( batteries excluded) Used Life Span of Battery 1000 times Software version Use Period 5 year Application part Out of contact the body,:onnect tub、shell contact the body :cuff Cuff Dimensions For arm circumference of 22~34cm(Special size to be ordered separately) Package Content Cuff ,Instruction Manual,Battery Set ,Warrant Card Note:Subject to modification without prior notice. 9. EMC Declaration Guidance and manufacturer’s 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. IEC 60601 Compliance Electromagnetic environment – Immunity test test level level guidance Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic tile. If floors are covered with discharge (ESD) ±8 kV air ±8 kV air synthetic material, the relative humidity IEC 61000-4-2 should be at least 30 %. Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a transient/burst typical commercial or hospital supply lines supply lines environment. IEC 61000-4-4 ±1 kV for input/output ±1 kV for input/output lines lines Surge ±1 kV differential ±1 kV differential Mains power quality should be that of a typical commercial or hospital IEC 61000-4-5 mode mode environment. ±2 kV common mode ±2 kV common mode 10 / 15

Voltage dips, short <5 % UT <5 % UT Mains power quality should be that of a interruptions and (>95 % dip in UT) (>95 % dip in UT) typical commercial or hospital for 0,5 cycle for 0,5 cycle environment. If the user of the voltage variations “XXX” requires on power supply 40 % UT 40 % UT continued operation during power input lines (60 % dip in UT) (60 % dip in UT) mains interruptions, it is recommended for 5 cycles for 5 cycles IEC 61000-4-11 that the “XXX” be 70 % UT 70 % UT powered from an uninterruptible power (30 % dip in UT) (30 % dip in UT) supply or a battery. for 25 cycles for 25 cycles <5 % UT <5 % UT (>95 % dip in UT) (>95 % dip in UT) for 5 sec for 5 sec Power frequency 3 A/m 3 A/m Power frequency magnetic fields (50/60 Hz) should be at levels characteristic of a typical location in a typical commercial magnetic field or hospital environment. IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of the test level. 11 / 15

EMC Declaration (Continued) Guidance and manufacturer’s 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. IEC 60601 test Compliance Immunity test Electromagnetic environment – guidance level level Portable and mobile RF communications 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 Vrms d=1.2√P Conducted RF 150 kHz to 80 MHz 3V IEC 61000-4-6 d=1.2√P 80MHz to 800MHz d=2.3 √P 800MHz to 2.5 GHz Radiated RF 3 V/m 3 V/m IEC 61000-4-3 80 MHz to 2,5 GHz 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 metres (m). Field strengths from fixed RF transmitters, as determined a by an electromagnetic site survey, 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 a 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 b 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

EMC Declaration Guidance and manufacturer’s 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 The “XXX” uses RF energy only for its RF emissions internal function. Therefore, its RF emissions are very Group 1 CISPR 11 low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class B CISPR 11 The “XXX” is suitable for use in all Harmonic emissions Class A establishments, including domestic establishments and those directly connected to the public low-voltage IEC 61000-3-2 power supply network that supplies buildings used for Voltage fluctuations/ domestic purposes. Complies flicker emissions IEC 61000-3-3 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 m Rated maximum output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz W 0,01 0.12 0.12 0.23 0,1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 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 P is 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

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Document Created: 2019-03-20 13:59:17
Document Modified: 2019-03-20 13:59:17
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