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TMB-1491-BS(FDA) | Users Manual | 5.46 MiB | ||||
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1 | TMB-1491-BS(FDA) | Users Manual | 5.46 MiB |
Version:1.0 TRANSTEK 1 rl
) I Usocl WIidaliiWadl Blood Pressure Monitor TMB-1491-BS _ Arm Type , FCC ID:OU9TMB1491BS Guangdong Transtek Medical Electronics Co., Ltd. wad Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China
= Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1491-BS
= Please do read the user manual carefully and thoroughtly so as to ensure the safe usage of this product, and keep the manual well for further reference in case you have problems. CATALOGUE CATALOGUE Table of Contents INTRODUCTION. 0... eccecceceeceecceceeceseeeeeeeeeeeeeceseeeesceesceaceaeeeeeseesecaeseesaeeseeaeeaecseceeceeeneteeeereeees General Description Indications for Use Contraindications Measurement Principle Safety Information LCD Display Signal Raanitar Oamnnnoantc SEE MEEPS EES e List BEFORE YOU START ...0.....cecc-cececcecesesceseseeeeeeeesecsesaenecececeacscsecseeacaesaesesecacsecstiecseseesteesseeeetaes 9 e The Choice of Power Supply e Installing and Replacing the Batteries e Setting Date, Time and Measurement Unit e Select the User Pair-up the Blood Pressure Monitor with Your Device MEASUREMENT..........2.22-2:cecescecesceceseeceseseeeseeeecaesecaceecececscsesacscescseeaesesacseacaeeecsceessceeeateeeseee 15 Tie the Cuff Start the Measurement DATA MANAGEMENT. ......2....2.:c-ceccccececeececesceceeeeeceeeecuseecuceecseeececsacseeecaesseaceececeeesceeeateeeeteees 18 e Recall the Records Delete the Records INFORMATION FOR USER ............-cescecesesceseseeeeeeeeseeeeeeeeececeecacseacseacseeecieescseeecsseecsteeeatees 20 e Tios for measurement e Maintenances ABOUT BLOOD PRESSURE ...........:.::cccececcecesceseseseeeeeeeseeesecaceecsceecaceeeaceeatseeeciecatseeeteeetaees e What are systolic pressure and diastolic pressure?
e What is the standard blood pressure classification?
e |rregular heartbeat detector Why goes my diood pressure tluctuate througnout the day Why do | get a different blood pressure at home compared to the hospital?
Is the result the same if measuring on the right arm?
TROUBLESHOOTING.. SPECIFICATIONS AUTHORIZED COMPONENT ... CONTACT INFORMATION.. FCC STATEMENT................ COMPLIED EUROPEAN STANDARDS LIST.... EWI OUIDAINGE...... 2... eee cece e cece cece eee ce eee eee e eee c nec ee cee eecee cee cecseceneeceeceeseceeceesecsecteceesenseceess 2d INTRODUCTION General Description INTRODUCTION v Safety Information Thank you for selecting TRANSTEK arm type blood pressure monitor
(TMB-1491-BS). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Readings taken by the TMB-1491-BS are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This manual contains important safety and care information, and provides step by step instructions for using the product. Read the manual thoroughly before using the product. Features:
*6Ummx40.9 mm Biue LOU with wnite backilignt
+ Maximum 60 records
+ 3rd technonoly: Measuring during inflation
(The updated technology in the world) Indications for Use The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm ( about 8%"-12%2" ) or 22cm to 42cm(about 8%"-1672). It is intended for adult indoor use only. an PPanntyuratinaAtaantiannr YF WME GHIUIVALIVITS 1.The device is not suitable for use on may be pregnant women or pregnant womel!
2.The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, defibrillators. Measurement Principle This product uses the Oscillometric Measuring method to detect blood pressure. Ne SIGNS DElOW MIQMt DE Il ne USer Manual, lavenng OF OlNer COMPONerit. They are the requirement of standard and using. Symbol for THE OPERATION Symbol for TYPE BF APPLIED GUIDE MUST BE READ PARTS Toy ee AA IDARIRAC ALE Symbol for MANUFACTURER Symbol for SERIAL NUMBER Symbol for DIRECT CURRENT MYER EE EEN EEN PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice For indoor use only Symbol for Class || Equipment F1 T1A/250V 03.6*10CCC Symbol for MANUFACTURE DATE Caution: These notes must be observed to prevent any Se ge
|G Symbol for Recycle
| Gal Mage lO le GEVICce. The Green Dot is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer qoods |
Before every measurement, the unit establishes a zero pressure equivalent to the air pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate. INTRODUCTION
(- /\ CAUTION
* This device is intended for adult use in homes only. INTRODUCTION
(- Z\ CAUTION , The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable
* The device is not suitable for use on neonatal patients, pregnant women, patients with implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or people who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from illnesses.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on older children.
* The device is not intended for patient transport outside a healthcare facility. not intended for public use. TTS GEVICe IS THRETGQeO TOF HO-TIVGSIVE THE aSuriny alt MOMlOnhiy OF aiterial VIOUU PIessuUre. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment without asking a physician for treatment advice.
* If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician.
* Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure.
* When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result.
* Don't kink the connection tube during use, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT.
* When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements; the application of the cuff and its pressurization on any i Si ga nc EIEIO LLL ID NES the side of a mastectomy.
* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME equipment. On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure (cuff pressure > 300mmHg or constant pressure > 15mmHg for more than 3 minutes) applied to the arm may lead to an ecchymosis. EMTs ME EE ERE EN EN EES LENE NP OEIMEES, IS ENED omMig tiene Please check that operation of the device does not result in prolonged impairment of patient blood circulation.
* When measurement, please avoid compression or restriction of the connection tubing.
* The device cannot be used with HF surgical equipment at the same time.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readinac the effecte of thic device on the fetic are unknown
* Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or operations.Otherwise, the patient's arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
* When not in use, store the device with the adapter in a dry room and protect it against extreme moisture, Buccs: Umeha wueecaell ellis veh exe wom BDiatct) sWbcei nao wiBiacecins eating Bccacesavaatahatiaiaes axaxEbiix ebsamceis Gonmn:
anesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
* The patient can measure ,transmit data and change batteries under normal circumstances and maintain the device and its accessories according to the user manual. To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal. The blood pressure monitor, its adaptor, and the cuff are suitable for use within the patient environment. TH YOU ale AHeigit lO PULYE Stel, MYlOl OF Piast, PICase GON tL USE Ulls VEVICe.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation reaction.
* Adaptor is specified as a part of ME EQUIPMENT.
* If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from your arm.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff from the arm and press the START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition. Check the device, do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause injury, improper results, or serious danger.
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The typical service life is 10000 times.
* hie ranammaendad that the narffarmanne chad he phenbed evan, 9 uaare and after maintanannes and NN EN EIRENE LE IES Os repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions,etc., to assist to service personnel in parts repair.
* The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a position where it is difficult to disconnect from the supply mains to safely terminate operation of ME equipment.
* The operator shall not touch output of batteries /adapter and the patient simultaneously.
* Cleaning :Dust environment may affect the performance of the unit. Please use the soft cloth to clean the whole unit before and after use. Dont use any abrasive or volatile cleaners. The device doesnt need to be calibrated within two years of reliable service. If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of Transtek. Dont open or repair the device by yourself in the event of malfunctions. The device must only be serviced, repaired and opened by individuals at authorized ealec/carvice canterc
* Please report to Transtek if any unexpected operation or events occur.
* Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small parts. It is dangerous or even fatal. Tee ee OTD NN NE EN AEE INT MMI
* This device may be used only for the purpose described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application.
*This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet. oor oe INTRODUCTION Be careful to strangulation due to cables and hoses, particularly due to excessive length.
(= /\ CAUTION I INTRODUCTION LUD aisplay signal
= ary: | ewe Atleast oU min required tor ME equipment to warm trom the minimum storage temperature between uses until it is ready for intended use. At least 30 min required for ME equipment to cool from the maximum storage temperature between uses until it is ready for intended use.
* This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS;
* Wireless communications equipment such as wireless home network devices, mobile phones, cordless telepnones and thelr Dase stations, walkle-talkles Can allect tnis equipment and should be kept at least adistance d away from the equipment. The distance d is calculated by the MANUFACTURER from the 80MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
* Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. ey
| PPETS fo MO 1UET TOOK COMMECIOLS are Use" Hl UIE COMSUUCHOF OF LUDITIY, WIETe ls a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.
* Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced. VUeY mkPa DIA AA A Cm) 0 Om| rs ft gkra m= mmHg Pul/min Do
co:
WL 9 ir oo) eg SYMBOL | DESCRIPTION | EXPLANATION eve Systolic blood pressure High blood pressure DIA Diastolic blood pressure Low blood pressure Pulimin Pulse display Pulse in beats per minute Deflation symbol The cuff is deflating. mr Maman;
Indicate it is in the memory mode and LIL TD WHICH Group OF Memory ils. kPa kPa Measurement Unit of the blood pressure mmHg mmHg Measurement Unit of the blood pressure t 6-0 Low battery Batteries are low and need to be replaced Blood pressure monitor is detecting an Irregular heartbeat irregular heartbeat during measurement. Blood pressure level indicator Indicate the blood pressure level Current Time Year/Month/Day, Hour/Minute Heartbeat Blood pressure monitor is detecting a heartbeat during measurement. User 1/User G/User 2 Start measurement for User 1/User G/User 2 0 Bluetooth i The bluetooth icon blinks when the uetooth Icon bluetooth is working INTRODUCTION v Monitor Components BEFORE YOU START v The Choice of Power Supply 1.Battery powered mode: TT Component list of pressure measuring syst 1 Cuff 2 Air pipe 3 PCBA A Ditmar AIR HOSE ws Mare i AIR CONNECTOR PLUG: DC POWER SOCKET ee MEM BUTTON SET BUTTON START/STOP BUTTON BATTERY COMPARTMENT LCD DISPLAY a i List 1.Blood Pressure Monitor 2.Cuff (Type BF applied part)
(TMB-1491-BS) (22cm~32cm or 22cm~42cm) aN (Diaaca tien TDANCTEK Cie Seen erer nae 6 DONTE wen Aen geen APE Teel te ee authorized cuff. The size of the actual cuff please refer to the label on the attached cuff.) OVDC 4xAAA alkaline batteries
2.AC adaptor powered mode: *)|
6V==-1A
(Please only use the recommended AC adaptor model). AC adaptor Flease unpiug the adaptor to depart trom the using utility power.
( /\CAUTION In order to get the best effect and protect your monitor,please use the righ gee ee le sp py gy gl,
\ RAUSTY aU SVevlal VOWS! AUAVLU! WITT! COMIVNGS WILT IOGd! Ssalely Stas) v Installing and Replacing the Batteries ES e QOnen the battery cover KK CP EEE EOE Install the batteries by matching the correct polarity, as shown. Replace the battery cover. Replace the batteries whenever the below happen The t 0+ shows e The display is dim.
| The display does not light up oe A ff ALITIC\VAL 3. 4xAAA alkaline batteries 4.User manual 5. AC Adaptor
(BLJO6LO60100P-U) LEAVIN TIM IN Do not use new and used batteries together. Do not use different types of batteries together. Do not dispose the batteries in fire. Batteries may explode or leak. Remove batteries if the device is not likely to be used for some time. Worn batteries are harmful to the environment. Do not dispose with daily garbage. Ramove the old hatteriec from the device following vour local recvecling aiidelinec BEFORE YOU START Setting Date, Time and Measurement Unit BEFORE YOU START 5 .Repeat steps 2 and 3 to set the [HOUR]
and [MINUTE]. 1S Important to set the clock before using your biood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. (The setting range of the year :20172057 time format:12 H/24H) OO
4.When the monitor is off, |
hold pressing SET for 3 seconds to enter the mode for year setting. Or when the monitor is off, PISss VEL MUNI SHUIUy, it will display the time. Then hold pressing SET button to enter the mode for year setting. 9 Precec the MEM to change the [YEAR]. Each press will increase the numeral by one in a cycling manner. 3.When you get the right vem emr KRvrer QC TT ta nant
\ WW eu t ue a 7 sve, pives wet Woet down and turn to next step.Repeat steps 2 and 3 to set the [MONTH] and [DAY]. ae 4.Repeat steps 2 and 3 to confirm the time format [12H] and [24h].
| po Ne 6.Repeat steps 2 and 3 to set the [UNIT].
x, _M a a te ent tha | CO uanll dAiernlay, c Aftnr thn), BANS LIS MET IS Set Be OEE MIM IAY donEfirst,then display all the settings you have done and then it will turn off. 10 aun |
Tat Nat NS Nem 11 BEFORE YOU START v Select the User BEFORE YOU START v Pair-up the Blood Pressure Monitor ee re 1.When the monitor is off , press and hold the MEM button to enter user setting mode. The user ID will blink. pa
2.Then press MEM button again, select the user ID user 1 , user 2 or user G. 3. After selecting the suitable user ID, press SET button to WILT FOUr VeVICe 1.Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding.
@\AlRRne the eee... eT. ALL ne pnwe net LeIA the CTADTICTAD LL, tte. te pte GBwVVIICIE US TEU IS OE PESOS GI MIM HIS SE PNMIN IOP MUU Lt ota pair-up. The symbol %g and a will be shown on the LCD alternatively, indicating pair-up is proceeding. SYS | | Sys mmHg a iinetg a wnt
a 3.Then please select the user ID you want to connect with your smartphone on the app to continute the pair-up. If SUCCEED, symbol 4 If FAIL, symbol '2 will be shown on the LCD. will be shown on the LCD. Ld |
4.The monitor will shut off after Pair-up process is namralntn contimm. nen the LU Wii turn OTT. MTP Bluetooth Module No.: LS51802 RF Frequency Range: 2402 MHz to 2480 MHz Output Power Range: <4dBm Supply Voltage: 1.8-3.6 V Transmitting Distance: 10 meters 13 BEFORE YOU START
( List of compatible devices: ) MEASUREMENT v Tie the Cuff For iOS devices:
The operating system must be iOS 8 or more, such as iPhone 4S, iPhone 5/5C/5S, iPhone 6/6 Plus and so on. For Android devices:
The operating system must be 4.3 or more.
/\\CAUTION e Interference may occur in the vicinity of equipment marked with the following cumbhal ()) And TAAR_1401_.RS may intarfaringa virinity alactricral anininmant nee ee I OE e Sensitive people, including pregnant women pre-eclamptic and those who implanted medical electronic instruments, should avoid using the unit whenever possible. e Keep the monitor at least 20 centimeters away from the human body
(especially the head) when the data transmission is proceeding after ae ee eet THEVA SUreriiciit. e To enable the data transmission function, this product should be paired to Bluetooth end at 2.4 GHz. How to mitigate possible interference?
1. The range between the device and BT end should be reasonably close, from 1 meter to 10 meters. Please ensure no obstacles between the device and BT end so as to obtain quality connection and to lower the RF output range. 2.To avoid interference, other electronic devices (particularly those with wireless transmission / Transmitter) should be kept at least 1 meter away from the monitor. 1. Remove all jewelry, such as watches and bracelets from your left arm.Note: If your doctor has diagnosed you with poor circulation in your left arm, use your right arm. 2. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight. 2 Unld voir arm with voir nalm faring iin and tie the riff ee EEE on your upper arm, then position the tube off-center toward the inner side of arm in line with the little finger. Or position the artery mark over the main artery (on the inside of your arm). Note: Locate the main artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery. ee ee ND IEE LE 4. The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm. 5, Sit comfortably with your tested arm resting on a flat surface. Place your elbow on a table so that the cuff is at the same level as your heart. Turn your palm upwards. Sit upright in a chair, and take 5-6 deen hreaths 6. Helpful tips for Patients, especially for Patients with Hypertension:
Rest for 5 minutes before first measuring. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. Take the measurement in a silent room. ETS POUCH TTMOL ICIGA Go TTL AS PUSSINIS GH UU TUL TOV GI Lan during the measurement procedure.
* The cuff should maintain at the same level as the right atrium of the heart.
* Please sit comfortably. Do not cross your legs and keep your feet flat on the ground. Keep your back against the backrest of the chair. e For a meaninaful comparison. trv to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same arm, or as directed by a physician. 14 15 MEASUREMENT v Start the Measurement 1.When the monitor is off, (ae MEASUREMENT If the data transmission fails, the Bluetooth symbol blinks all the time until it turns off. press the START/STOP to turn on SS the monitor, and it will finish the whole measurement .(Take User 1 for example) LCD display Adjust the zero. ney |
"ams van on | mn 4 AAa&k v In v | Pulmin
( es bese Inflating and measuring. Display and save the results.
, The device will proceed to data
= mM transmission after measurement.
= =i, SYS The Bluetooth symbol blinks on f 1 | wkPa te LAM te ete De te be db
=a | =r DIA mkPa
> | mmmHg v v Pul/min He bw WI Ales Udla Ilo UAGOITLUTY. SYS mkPa mmmHg fn vv If the data transmission succeeds, the Bluetooth symbol will disappear. e->_, o |. mkPa
= > | mmmHg
| DIA
| mkpa mmHg
| a
( il
D8 i | Pul/min 9 Drace the START/STOP hiittan to power off, otherwise it will turn off within 1 minute. 16 17 DATA MANAGEMENT Recall the Records 4 640% lace 1. When the monitor is off, DATA MANAGEMENT Delete the Records If vou did not get the correct measurement. vou can delete all please press the MEM to show the average value of the latest three records. If the records are less than three groups, it will display thea latact racord firet aD, Ce _ 2. Press the MEM or SET to get the record you want. ee LY ft LeEJ tt, t The date and time Sy me meng of the record C tot PM LS will be shown : / /
alternately. , Thecurrent No. is No 2. The corresponding The corresponding
OO | date is January 1st. time is P.M. 10:08. |
WK ART ITI-AL I results by following steps below. 1.Hold pressing MEM M for 3 seconds when the a
MOMMLOF iS I) tne memory:
recall mode ,the flash display will show. IN 2.Press SET to confirm deleting and the monitor will turn off. on S _ 3.If you dont want to delete the records. press START/STOP to escape. 4. lf there is no record, the right display will show.
[IAIN TIMIIN The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped 18 19 INFORMATION FOR USER mee me ame eee lg v Tips fOr Measurement INFORMATION FOR USER ee RAai ntanannnr
~ MWIGMILULanivVw Measurements may be inaccurate if taken in the following circumstances.
Ry A /
DP WS Within 1 hour x Immediate measurement after dinner or drinking after tea, coffee, smoking Within 20 minutes after taking a bath When talking or moving your fingers In order to get the best performance, please follow the instructions below.
Gm! |
Avoid touching water, clean it with a dry cloth in case. S|
Avoid intense shaking and collisions temperature environment EN Using wet cloths to remove dirt Do not attempt to clean the reusable cuff with water and never immerse the cuff in water. 20 PAKY In a very cold environment
\S x ror When you want to discharge urine 21 ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the OQ atalin. _Minetalin. ABOUT BLOOD PRESSURE gv Why doec my hlood nrecciira EE EE EEE EE EEE 1Lprtiiatn therairimhaist tha Miaiv tii blood entering vein
relax e fw wwe eyes heart, the blood pressure reaches its maximum valUe | pic04 discharging in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure. artery What is the standard blood pressure classification The chart on the right is the standard blood pressure classifi-
cation published by American Heart Association (AHA). This chart reflects blood pressure categories defined by American Heart Association. Blood Pressure Category Systolic Diastolic mmHg (upper#) mmbdg (lower#) Normal less than 120 and | less than 80 Elevated 120-129 and less than 80 High Blood Pressure 130-139 or 80-89
(Hypertension) Stage 1 High Blood Pressure 140 or higher or 90 or higher
(Hypertension) Stage 2 Hypertensive Crisis Higher than 180 |and/ Higher than 120
(Consult your doctor immediately) lgnertnan ancior 9 S
/\\. CAUTION Please consult a physician if your measuring result falls outside the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point.
|lrregular Heartbeat Detector An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.During each measurement, the monitor records all the pulse intervals and calculate the average ; if there are two or more pulse intervals ,the differenc between each interval and the average is more than the average value of +25% , or there are fc or more pulse intervals the difference between each interval and the averace is more than the ee i ER OO gf average value of 15% ithe irregular | heartbeat symbol appears on the display when the PENS CUICLEN BEET ORE Ee LEE day?
1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conaitions. / ,}_ \
2.If the person takes medicine, the =
pressure will vary more. 3.Wait at least 3 minutes for another measurement. Why do! get a different What you need to pay blood pressure at home attention to wnen you measure our blood pressure at home:
i y compared to the hospital? If the cuff is tied properly. The blood pressure is different even If the cuff is too tight or too loose. throughout the day due to weather, If the cuff is tied on the upper arm.
: : : If you feel anxious. emotion, exercise etc, Also, there is the y jo . Taking 2-3 deep breaths before white coat effect, which means blood beginning will be better for measuring. J pressure Usually Increases In Clinical Advice: Relax yourself for 4-5 settings. minutes until you calm down. Is the result the same if measuring on the u right arm?
It is ok for both arms, but there measurement results are appear. AN CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-
beat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does 22| not replace a cardiac examination, but serves to detect pulse irregularities at an early stage. Wil be some alirerent results Tor different people. We suggest you measure the same arm every time. 23 TROUBLESHOOTING This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood ge ig ig lg SPECIFICATIONS Battery powered mode:
| 6VDC 4*AAA alkaline batteries PFesoUre MIOMILOP, TU PrOQUucts MUL OVeraling ds YOU UTITIA It should, check here before arranging for servicing. PROBLEM | SYMPTOM | CHECK THIS REMEDY a Batteries are exhausted. Replace with new batteries No power Uisplay WHI TOL light up. Batteries are inserted incorrectly. Insert the batteries correctly AC adaptor is inserted incorrectly. Insert the AC adaptor tightly Low Display is dim or batteries show tg+0 ballerles are low. Replace with new batteries E 01 shows The cuff is too tight or too loose. Readjust the cuff ,not too loose or too tight and then measure again. E 02 shows The monitor detected ge eg Ralay for a
| moment and then pluse is too poor measure again. THUUUTT LAINIE UF Ute
| | while measuring. Error E 03 shows The measurement Loosen the clothing on the message process does not detect |arm and then measure the pulse signal. again E 04 shows The treatment of the measurement failed. Relax for a moment and then measure again. FEyy shows on A calibration error Retake the measurement. If the problem persists, occurred. contact the retailer or our customer service department for further agecictancea Refer tn tha the display. Power supply AC adaptor powered mode: 6y =1A
(Please only use the recommended AC adaptor model). Display mode Blue LCD with white backlight V.A.60mmx40.5mm Measurement mode Oscillographic testing mode Rated cuff pressure:
Measurement range Accuracy UVITTMIG 2S STTIIQuunRr a ~ OF.SKr a) Measurement pressure:
SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) DIA: 40mmHg~130mmbg (5.3kPa~17.3kPa) Pulse value: (40-199)beat/minute Pressure:
5C-40Cwithint0.4kPa(3mmHg)
|_ Pulse value:+5%
A temperature range of :+5C to +40C A relative humidity range of 15% to 90%, Normal working condition | non-condensing, but not requiring a water vapour partial pressure greater than 50 hPa An atmospheric pressure range of :
700 hPa to 1060 hPa Temperature:-20C to +60C A relative humidity range of < 93%, non-condensing at a water vapour pressure up to 50hPa Storage & transportation condition Measurement perimeter About 22cm~32cm or 22cm~42?cm of the upper arm Net Weight Approx.182g(Excluding the dry cells) External dimensions Approx.110mmx110mmx41mm Attachment l4xAAA alkaline batteries, user manual,AC adapter Mode of operation Continuous operation Manran af nrnatartinn TTimn DO arnnwli-d nart ee yiteh ME PEM EINEE pee et Sees
. IP21 It means the device could protected Protection against against solid foreign objects of 12.5mm and innrace af watar areater and pvrotect aqainst vertically falling warranty for contact information and return Relax for a moment. Refasten the cuff and then measure again. If the nrnhlam narcicte erontact Warning eae Out of measurement out shows message range eeeeEeE Ere O_TOe your physician. ee EE Device Classification Software Version water drops. Battery Powered Mode:
Internally Powered ME Equipment AC Adaptor Powered Mode:
Class II ME Equipment AO1 9a WARNING: No modification of this equipment is allowed. AUTHORIZED COMPONENT
~ Authorized Component FCC STATEMENT an FE" MM @4-4- we met 1. please use the TRANSTEK authorized adapter. Adapter Type: BLJOGLO60100P-U Input: 100~240V,50~60Hz,0.2A Max Output: 6V 1A Contact Information For more information about our products, please visit www.transtek.cn.you can get customer service, usual problems and customer download, transtek will serve you anytime. Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd. Company: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone B, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guangdong,China wh VGLGALOTICIt FCC ID:OU9TMB1491BS This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, Linn gg gt gg ty TIMI Hee relive tlcal Thay VAMOS UNM SOHeM UVEIALIUIT. Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses 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 orciir in 4 narticiular inetallatinn 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. rs i
-- 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. FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. COMPLIED STANDARDS LIST Complied Standards List EMC GUIDANCE EMC Guidance
. EN TOU IGE LLU IS 1 IOU I49 1 1. 2UUT Medical GevIces Risk management Application of risk management to medical devices EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and Labeling information to be supplied. Part 1 : General requirements User manual EN 1041:2008 Information supplied by the manufacturer of medical i EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical General Requirements electrical equipment - Part 1: General requirements for basic safety for Safety and essential performance EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home hasltheare anviranmant Electromagnetic EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical wp o-pe. equipment - Part 1-2: General requirements for basic safety and compatib ity essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests Performance EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
. Requirements and test methods for non-automated measurement type requirements quirements and test methods typ eee eae EE INS SPY IANS StS Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test res MEE EEE AES MESES YORE tay Soreness non-invasive sphygmomanometers Clinical investigation ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 62366-1:2015 Medical devices - Part 1: Application of
[usability engineering to medical devices Software life-cycle EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical processes device software - Software life-cycle processes 1) This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment. 2)* Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit. 3)Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!
4)* Caution: This machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in vasrhiak itiuanll hA prernA VVEEINSE EER VVEEE Wwe Mow. Table 1 Guidance and manufacturers declaration electromagnetic emissions 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. je cyitahle for tice in all ectahlichmentc AP SHS CISPR 11 Class B other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions ALLA ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010 Biological evaluation of medical devices -
Part 10: Tests for irritation and skin sensitization IEC 61000-3-2 Voltage fluctuations/
flicker emissions Complies IEC 61000-3-3 EMC GUIDANCE Table 2 EMC GUIDANCE Table 3 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. Elect ti IEC 60601 test level Compliance level environment. guidance Floors should be wood, concrete or ceramic tile. If floors are Electrostatic discharge (ESD) oe Wy ontact +8 kV contact covered with synthetic material,
+ . a IEC 61000-4-2 alr 215kV air the relative humidity should be at least 30%. Electrical fast power supply lines: power supply lines: Maine paver aaliny chard he ee NN ENE EE transient/burst 22 kV 22 kV that of a typical commercial or IEC 61000-4-4 input/output lines: hospital environment. t1kV Surge els) to wnels) st line(s) to line(s): 1 kV Mains power quality should be 1EC61000-4-5 ine(s) to earth: that of a typical commercial or 100 kHz repetition 100 kHz repetition hospital environment. frequency frequency Voltage dips, short interruptions and voltage variations on power supply 0%Ur, 0.5 cycle At 0, 45, 90, 135, 180,225,270 and 315 O%Ur; 1 cycle and 70%Ut ; 25/30 cycles Single phase: at 0 0% Ur; 300 cycle 0% Ur ; 0.5 cycle At 0, 45, 90, 135, 180,225,270 and 315 0% Ur; 1 cycle and 70% Ur ; 25/30 cycles Single phase: at 0 Mains power quality should be that of a typical commercial or hospital environment. el eel IEC 61000-4-11 0% Ur ;300 cycle Power frequency Power frequency magnetic fields should be at levels characteristic
(50Hz/60Hz) . oe :
magnetic field 30 A/m 30 A/m of a typical location ina typical 50Hz/60Hz 50Hz/60Hz commercial or hospital SG ar EEN MEE MEM ATGLIMEE She enrasytiheerm 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 60601 Compliance Test level level Conducted RF | 150 kHz to 150 kHz to On AALIR On AALJne IEC O1U0U-4-6 eu Ne. eee EMMIPEMETIL SHUUIN RE MSE TID MIVSEE WU ITY Part 3 Vrms 3 Vrms of the device, including cables, than the 6Vrms (in ISM 6Vrms (inISM__| recommended separation distance calculated and amateur and amateur from the equation appropriate for the frequency radio bands) radio bands) of the transmitter. 80% Am at 1kHz| 80% Am at 1kHz| Recommended separation distances:
d=0.35VP ;
d=1.2/P Doe DE ami. enor. lam. enor a. | en auc. enn natu. Iwhere Die the mayimum NMA ENE EMME MORE RENEE DEMME MOMSEN | Me IEC 61000-4-3 at 1kHz at 1kHz d=1.2/P output power rating of the 800 MHz to 2.7 GHz: | transmitter in watts (W) d=2.3/p according to the transmitter manufacturer, dis 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 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. a 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 IEG 01000-4-6 STN TPORTTST. NOTE Uy is the mains voltage prior to application of the test level. strengt in the location in which the Gevice is used exceeds the applicable Nr Compliance lever 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. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. EMC GUIDANCE Table 4 EMC GUIDANCE Table 5 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
(transmittters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output Separation distance according to frequency of transmitter (m) power of transmitter
(Ww) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz d= 3.5/p d=1.2\P d=23\P For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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. Guidance and manufacturers 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. Radiated RF | Test Band a) | Service a) | Modulation b) | Modulation b)| Distance (m)|!MMUNITY}
1EC61000-4-3] Frequency] (MHz) (w) eve LEVEL
(Test (MHz) (vin) specifications for 385 |380-390 | TETRA | Pulse 18 03 ar ENCLOSURE} Ann rn PORT IMMUNITY to. RF wireless. communicatio|
ns equipment) NE NE 18Hz MRS 460,] FM c) + 5kHz 450 380-390 FRS 460 | deviation 1kH 2 03 28 sine 710 [704-787 |LTE Band | Pulse 745 13, modulation b)} 0.2 03 9 720 17 217Hz
[GSM Pulse 2 810 | 800960 |=" [Pulse 03 28 are i TETRA 800, 870 ben eco. | 18H2 CDMA 850, 930 LTE Band 5 1720 | 1700- [GSM 1800; | Pulse 1990 jeoma onta modulation b) 03 28
| 217H 1845 DECT; 2 LTE Band 1, 1970 3, A OK IMTS Bluetooth, [Pulse 2 2450 nO WLAN, {modulation b) o8 *
302.11 |217 Hz bigin, RFID]
2450, LTE Band 7 5240 |5100- | WLAN | Pulse 02 03 9 5800 802.11 | modulation b) DAN _ 47 Li 5785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included b) The carrier shall be modulated using a 50% duty cycle square wave signal. c) As an altemative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does HOUTEPreserl atta THOCGUIGLOR, H WOU De WOPst Gast. The MANUFACTURER should consider reducing the minimum separation distance, based on RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be}
calculated using the following equation:
rc a Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in Vim
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2018-08-16 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2018-08-16
|
||||
1 | Applicant's complete, legal business name |
Guangdong Transtek Medical Electronics Co.,Ltd
|
||||
1 | FCC Registration Number (FRN) |
0021999248
|
||||
1 | Physical Address |
Zone A, No.105,Dongli Road
|
||||
1 |
Zhongshan, Guangdong, N/A 528437
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
a******@babt.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
OU9
|
||||
1 | Equipment Product Code |
TMB1491BS
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
K****** T********
|
||||
1 | Title |
R&D Director
|
||||
1 | Telephone Number |
+86-7********
|
||||
1 | Fax Number |
+86-7********
|
||||
1 |
q******@transtekcorp.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Bluetooth Blood Pressure Monitor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power is peak conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
TUV SUD Product Service
|
||||
1 | Name |
M**** J******
|
||||
1 | Telephone Number |
00-44********
|
||||
1 | Fax Number |
00-44********
|
||||
1 |
m******@tuv-sud.co.uk
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0006970 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC