RENPHO TMB-1872-B Smart Blood Pressure Monitors Upper Arm Blood Pressure Machine with App User Manual

RENPHO TMB-1872-B Smart Blood Pressure Monitors Upper Arm Blood Pressure

Machine with App

INTRODUCTION

General Description

• Thank you for selecting the RENPHO Arm Type Blood Pressure
• Monitor (TMB-1872-B). 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-1872-B 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

• 2.36*2.91in Digital LCD display
• Maximum 120 records per user
• Measuring during inflation technology
• Indications for Use
• The RENPHO Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 42cm (about 8¾”-16½”).
• It’s intended for indoor use by adults only.

Contraindications

1. The device should not be used by any person who may be suspected of or is pregnant.
2. The device is not suitable for patients with implanted, electrical devices, such as cardiac pacemakers, and defibrillators.

Measurement Principle

This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero pressure” equivalent to atmospheric 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, as also pulse rate.

Safety Information

• The signs below might be in the user manual, labeling, or other component.

CAUTION

• This device is intended for adult use in homes only.
• The device is not suitable for neonatal patients, pregnant women, patients with implanted, electronic devices, patients with pre-ec- lampsia, 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.
• The device is not intended for public use.
• This device is intended for non-invasive measuring and monitoring of arterial blood pressure. 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 prescribed medication without consulting your physician.
• Do not take any therapeutic measures on the basis of a self-measurement. Never alter the dose of medicine prescribed by a doctor.
• Consult your doctor if you have any questions about your blood pressure.
• When the device is 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 injury to the PATIENT.
• When using this device, please pay attention to the following situations which may interrupt blood flow and influence blood circulation of the patient, thus causing injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements; the application of the cuff and its pressur- ization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on 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 to which other monitoring ME equipment is applied 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 ecchymosis.
• Please check that the operation of the device does not result in prolonged impairment of patient blood circulation.
• When measuring, 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.
• To verify the calibration of the AUTOMATED SPHYGMOMANOM- ETER, please contact the manufacturer.
• This device is contraindicated for any female who may be susp- ected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus 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 in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.
• 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.
• The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable 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. If you are allergic to polyester, nylon or plastic, please don’t use this device.
• During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with the requirements of ISO10993-5 and ISO10993-10. It will not cause any potential sensation or irritation reaction.
• The adaptor is specified as a part of ME EQUIPMENT.
• If you experience discomfort during 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 the pressure 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 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.
• It is recommended that the performance should be checked after maintenance and 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.
• The manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, etc., to assist 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 the operation of ME equipment.
• The operator shall not touch the output of the batteries/adapter and the patient simultaneously.
  • Cleaning: A dust environment may affect the performance of the unit. Please use a soft cloth to clean the whole unit before and after use. Don’t use any abrasive or volatile cleaners.
• The device doesn’t 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 it, please contact the SERVICE PERSONNEL of RENPHO. Don’t 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 sales/service centers.
• Please report to RENPHO if any unexpected operations 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.
• Be careful to strangulation due to cables and hoses, particularly due to excessive length.
• At least 30 minutes are required for ME equipment to warm from the minimum storage temperature between uses until it is ready for intended use. At least 30 minutes are required for ME equipment to cool from the maximum storage temperature between uses until it is ready for the 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 telephones, and their base stations, and walkie-talkies can affect this equipment and should be kept at least a distance d away from the equipment.
• The distance is calculated by the MANUFACTURER from the 80MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2, as appropriate.
• Please use ACCESSORIES and detachable parts specified/authorized by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
• There are no luer lock connectors in the construction of tubing.
• There is 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 is indicated in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.

LCD Display Signal

Monitor Components

Component list of pressure measuring system

1. Cuff
2. Air pipe
3. PCBA
4. Pump
5. Valve

List

APP OPERATION GUIDE

Download

1. Search and download “Renpho Health” from Apple Store / Google Play or scan the QR code below to download the app.
   • (The images shown are for illustration purposes only and may not be an exact representation due to the app update)
2. Open the app. Register with your email address and fill in your personal information (this is required for calculating accurate health measurements). If you already have an account, tap “Login”.

Add Device

1. After logging in, you will be directed to the homepage as shown below.
2. Activate Bluetooth on your phone, press the User button of the blood pressure monitor (the Bluetooth icon will flash on the display).
3. A pop-up window will appear to allow you to pair your phone with the device.

Alternatively, click “ ” on the right corner to connect manually.

1. Activate Bluetooth on your smartphone.
2. Click “ ” on the right corner.
3. Click “Blood Pressure Monitor (Bluetooth)” to search for the device.
4. Press the User button on the blood pressure monitor (the Bluetooth icon will flash on the display)
5. Click to connect.

Select the “Blood Pressure Monitor” on the “Device” page to connect for the next use. Swipe left and click to delete to disconnect the device.

Note: The blood pressure monitor can be paired with one device only. If you want to connect it with another device, please ensure it is fully disconnected from any prior device.

Add User 1

• After pairing, you need to add a user profile if you connect the device for the first time.
• After filling in the user information as shown below, click “Next step” to save and you will be directed to the homepage (“Records” interface).
• The “Bluetooth” icon will light up once the device has been paired successfully.

Synchronize the Existing Data

After entering the homepage, you need to synchronize the existing measurement data of the device on the app.

1. Press the “MEM” button on the blood pressure monitor.
2. Restart the app and enter the “Records” page.
3. The data will be synchronized once the “Bluetooth” icon lights up.
   • Note: The same measurement data can be synchronized for one account only.

Check Measurement Record

• Check your measurement data on a daily, weekly, monthly, or yearly basis on the “Records” page.
• Click any measurement data to add remarks that will be displayed along with it.
• Swipe left and click to delete the data.

Check Calendar

1. Enter the “Calendar” page to get a holistic view of the dates of measurement.
2. Click the day with a blue dot to check the measurement data of that day.
3. Click the data to add remarks or swipe left to delete as mentioned in the part of “Check Measurement Record”.
4. You can click “Choose Data” to delete multiple data at once.

Share
Enter the “Share” page and select the time period to share your measurement results in a CSV file.

Setting
Enter the “Setting” page to adjust the following functions.

Add User 2

1. Ensure the device is paired with the app (“Bluetooth” icon solid on the “Records” interface).
2. Enter the “Setting” page and select “Add User”. Add the user profile following the in-app instructions.
3. After adding the user, you can switch between “User 1” and “User
4. on the “Records” interface. Ensure the device has been disconnected from the app (“Bluetooth” icon turned off) when you switch the user.

The Choice of Power Supply

1. Battery-powered mode: 6VDC 4*AAA batteries
2. AC adaptor powered mode: 5V=1A

Please use the AC adaptor (not included) and USB cable just like in the following picture:

CAUTION
In order to get the best effect and protect your monitor, please use the right battery and special power adaptor which complies with local safety standards.

Installing and Replacing the Batteries

• Slide off the battery cover.
• Install the batteries by matching the correct polarity, as shown.
• Place the battery cover back.

Replace the batteries whenever the below happens

• The D shows
• The display is dim
• The display does not light up

CAUTION

• Do not use new and used batteries together.
• Do not use different types of batteries together.
• Do not dispose of the batteries in the 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 of daily garbage.
• Remove the old batteries from the device following your local recycling guidelines.

Notice This symbol on the device or its packaging indicates:

• Do not dispose of electrical appliances as unsorted municipal waste; use separate collection facilities.
• Contact your local authority for information regarding the collection systems available.
• If electrical appliances are disposed of in landfills or dumps, hazardous substances can leak into the groundwater and get into the food chain, damaging your health and well-being.
• When replacing old appliances with new ones, the retailer is legally obliged to take back your old appliance for disposal at least free of charge.

Setting Date, Time
It is important to set the clock before using your blood 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: 2020–2060)

1. When the monitor is off, press and hold the “START/STOP” button for 3 seconds to enter the mode for the year setting.
2. Press the “USER” button or “MEM” button to change the [YEAR]. Each press will increase or decrease the numeral by one in a cycling manner.
3. When you get the right year, press the “START/STOP” button to set down and turn to next step.
4. Repeat step 2 and step 3 to set the [MONTH] and [DAY].
5. Repeat step 2 and step 3 to set the [HOUR] and [MINUTE].
6. After the [MINUTE] is set, the LCD will display “donE” first, then display all the settings you have done and then it will turn off.

Select the User

1. When the monitor is off, press the “USER” button shortly to enter the user setting mode.
2. Then press the “USER” button again to select the user ID between user 1 and user 2.
3. After selecting the suitable user ID, press the “START/STOP” button to confirm and it will start to measure.

MEASUREMENT

Tie the Cuff

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.
3. Hold your arm with your palm facing up and tie the cuff on your upper arm, then position the tube off-center toward the inner side of the arm in line with the little finger. Or position the artery mark o over the main artery (on the inside of your arm).
   • Note: Locate the main artery by pressing with 2 fingers approximately 2cm/0.79in 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. 2~3cm/0.79~1.18in
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 deep breaths.
6. Helpful tips for Patients, especially for Patients with Hypertension:
   • Rest for 5 minutes before the first measurement.
   • Wait at least 3 minutes between measurements. This allows your blood circulation to recover.
   • Take the measurement in a silent room.
   • The patient must relax as much as possible and not move or talk during the measurement procedure.
   • The cuff should maintain 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.
   • For a meaningful comparison, try to measure under similar conditions.
7. For example, take daily measurements at approximately the same time, on the same arm, or as directed by a physician.

Start the Measurement

1. When the monitor is off, press the “START/STOP” button to turn on the monitor, and it will finish the whole measurement.
   • Inflating and measuring.
   • Display and save the results.
2. Press the “Start/Stop” button to power off, otherwise, it will turn off after about 1 minute.

DATA MANAGEMENT

Recall the Records

1. When the monitor is off, please press the “MEM” button to show the recent record. If the records are less than 3 groups, it will display the latest record instead. Take user 1 for example.
2. Press the “MEM” button to get the record you want. The date and time of the record will be shown alternately.
   • The date and time of the record will be shown alternately.

CAUTION
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 (120) is dropped from the list.

Delete the Records
If you did not get the correct measurement, you can delete the results by following the steps below.

A: Delete one record

1. Hold pressing the “MEM” button for 3 seconds when the monitor is in the memory recall mode, and the flash display “dEL one+User ID” will show.
2. Press the “USER” button or “MEM” button and the flash displays “dEL n” or “dEL y”.
3. Press the “START/STOP” button shortly to confirm deleting this group result when it shows “dEL y” and displays “USER ID + dEL donE”, then the device will show the latest record.
   • Tips: Press the “START/STOP” when it shows “dEL n”, it will drop out.

B: Delete all records

1. Hold pressing the “MEM” button and “USER” button for 3 seconds when the monitor is in the memory recall mode, and the flash display “USER ID+dELy USEr” will show.
2. Press the “USER” button or “MEM” button and the flash displays “dEL n” or “dEL y”.
3. Press the “START/STOP” button shortly to confirm deleting this group result when it shows “dEL y” and displays “USER ID + dEL donE”, then the device will turn off.
   • Tips: Press the “START/STOP” when it shows “dEL n”, it will drop out.
4. If there is no record, it will display like the right picture.

INFORMATION FOR USERS

Tips for Measurement
Measurements may be inaccurate if taken under the following circumstances

Maintenance

Please calibrate the blood pressure monitor in a specific institute once every two years to ensure precise measurements. In order to get the best performance, please follow the instructions below for storage

ABOUT BLOOD PRESSURE

What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value 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.

What is the standard blood pressure classification?

• The blood pressure classification published by the World Health
• Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:

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.

L evel
Blood
Pressure (mm Hg)| Optimal| Normal| H igh- norma l| Mild| Moderate| Severe
---|---|---|---|---|---|---
SYS| < 1 20| 120-129| 130-139| 140-159| 160-179| 2:180
OIA| <80| 80-84| 85-89| 90-99| 100-109| ****

2: 11 0

Irregular Heartbeat Detector

• An irregular heartbeat is detected when a heartbeat rhythm varies while the device is measuring systolic pressure and diastolic pressure.
• During each measurement, the blood pressure monitor will keep a record of all the pulse intervals and calculate the average value of them.
• If there are two or more pulse intervals, the difference between each interval and the average is more than the average value of
• +25% or there are four or more pulse intervals, the difference between each interval and the average is more than the average value of
• ‡15%, then the irregular heartbeat symbol will appear on the display with the measurement result.

CAUTION

• The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat 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 not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

Why does my blood pressure fluctuate throughout the day?

1. Individual blood pressure varies multiple times every day. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions.
2. If the person takes medicine, the pressure will vary more.
3. Wait at least 3 minutes for another measurement.

Why do I get a different blood pressure at home compared to the hospital?

• The blood pressure is different even throughout the day due to weather, emotion, exercise, etc. Also, there is the “white coat” effect, which means blood pressure usually increases in clinical settings.
• What you need to pay attention to when you measure your blood pressure at home:
• If the cuff is tied properly. If the cuff is too tight or too loose. If the cuff is tied on the upper arm. If you feel anxious. Taking 2-3 deep breaths before beginning will be better for measuring.
• Advice: Relax yourself for 4-5 minutes until you calm down.

Is the result the same if measuring on the right arm?

• It is okay for both arms, but there will be some different results for different people. We suggest you measure the same arm every time.

Authorized Components

1. Please use the manufacturer-authorized AC adaptor (Not included)

Adapter

• Input: 100~240V, 50~60Hz, 0.2Amax
• Output: 5V==1000mA BLJ06L050100U-B

Contact Information

Please feel free to contact us if there is anything we can help. We’ll try our best to improve the product quality and service. All products come with a warranty and lifetime support.

• Web: www.renpho.com.
• Email: support-eu@renpho.com.
• TEL: +44(0)7434 666088(UK)
• Monday-Friday 9:00 AM-5:00 PM (GMT)

TROUBLESHOOTING

Power supply| Battery-powered mode: 6VDC 4*AM batteries

AC adaptor powered mode: 5V=1A (Not included)

(Please use the AC adaptor authorized by the manufacturer)

---|---
Display mode| Digital LCD display V.A.2.36in*2.91in (60mm•?4mm)
Measurement mode| Oscillographic testing mode
Measurement range| Rated cuff pressure: 0mmHg-299mmHg Measurement pressure: SYS: 60mmHg-230mmHg DIA: 40mmHg-130mmHg

Pulse value: (40-199)be a minute

Accuracy| Pressure:

41°F-104°F (5°C-40°C) within±3mmHg

Pulse value: ±5%

Normal working condition| A temperature range of:

41°F to +104°F(+5°C to +40°C)

A relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapor partial pressure greater than 50hPa An atmospheric pressure range of:

?00hPa to 1060hPa

Storage & transportation condition| Temperature: -4°F to +140°F (-20°C to +60°C)
A relative humidity range of, 93%, non-condensing, at a water vapor pressure of up to 50hPa
Measurement perimeter of the upper arm|

About 8.66in-16.53in (22cm-42cm)

---|---
Net Weight| Approx.184g(Excluding the batteries)
External dimensions| Approx.3.66in•5.12in•1.28in (93mm•130mm•33mm)
Attachment| 4•AAA batteries, cuff, USB cable, carrying case, user manual, quick guide
Mode of operation|

Continuous operation

Device Classification

| Battery Powered Mode:

Internally Powered ME Equipment AC Adaptor Powered Mode: Class II ME Equipment

Degree of protection| Type BF applied part
Protection against ingress of water| IP21 It means the device could be protected against solid foreign objects of 12.5mm

and greater, and protect against vertically falling water drops.

Software Version| A01

WARNING: No modification of this equipment is allowed.

EMC GUIDANCE

• The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
  • Warning: Don’t be near the active HF surgical equipment and the RF-shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
  • Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
  • Warning: Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electro-magnetic immunity of this equipment and result in improper operation.
  • Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment
• TMB-1872-B including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Technical description:

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration-electromagnetic emissions and Immunity

Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test| Compliance
RF emissions CISPR 11| ****

Group 1

RF emissions CISPR 11| ****

Class [ B]

Harmonic emissions IEC 61000-3-2| ****

Class A

Voltage fluctuations/flicker emissions

IEC 61000-3-3

| ****

Comply

Table 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2

Test level

| Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2| ±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

| ±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

Electrical fast transient/burst IEC 61000-4-4| ±2 kV for power supply lines

±1 kV signal input/output 100 kHz repetition frequency

| ±2 kV for power supply lines Not Applicable

100 kHz repetition frequency

Surge IEC61000-4-5| ±0.5 kV, ±1 kV differential mode

±0.5 kV, ±1 kV, ±2 kV common mode

| ±0.5 kV, ±1 kV differential mode Not Applicable
Voltage dips, short interruptions and voltage

variations on power supply input lines IEC 61000-4-11

| 0% UT; 0,5 cycle. At 0°, 45°,

90°,135°,180°, 225°, 270°

and 315°.0% UT; 1 cycle and 70% UT; 25/30 cycles; Single phase: at 0°.0% UT; 250 /

300 cycle

| 0% UT; 0,5 cycle. At 0°, 45°,

90°, 135°,180°, 225°, 270° and

315°.0% UT; 1 cycle and 70% UT; 25/30 cycles; Single phase: at 0°.0% UT; 250 / 300 cycle

Power frequency magnetic field IEC 61000-4-8| 30 Alm

50 Hz/ 60 Hz

| 30Alm

50 Hz/ 60 Hz

Conducted RF IEC61000-4-6| 3V

0,15 MHz-80 MHz

6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz80% AM at 1 kHz

| 3V

0,15 MHz- 80 MHz

6 Vin ISM and amateur radio bands between 0,15 MHz and 80 MHz80% AM at 1 kHz

Radiated RF IEC61000-4-3| 10V/m

80 MHz – 2,7 GHz

80% AM at 1 kHz

| 10V/m

80 MHz- 2,7 GHz

80% AM at 1 kHz

NOTE UT is the a.c. mains voltage prior to application of the test level.

Table 3

Radiated RF IEC6100 0-4-3

(Test specifica- tions for ENCLO- SURE PORT IMMUNI-

TY to RF wireless commu- nicati- ons equip- ment)

| Test Frequency (MHz)| Band

(MHz)

| Service| Modu la tion| Maximum Power (W)| Distance

(m)

| IEC

6060 1 -1-2

Test Le ve l

(V/m)

| Compliance level

(V i m )

385| 380-390| TETRA 400| Pulse

modulation 18 Hz

| 1.8| 0.3| 27| 27
450| 430-470| GMRS 460,

FRS 460

| FM ±5kHz

deviation

1 kHz sine

| | 0.3| 28| 28
_7_10

780

| 704-787| LTE Band

13,

17

| Pulse modulation 217 Hz| 0.2| 0.3| |
810

870

930

| 800-960| GSM

800/900,

TETRA 800,

iDEN 820, COMA850 ,

LTE Band 5

| Pulse modulation 18 Hz| | 0.3| 28| 28
1720

—19

1845

1970

| 1700 –

90

| GSM 1800 ;

CDMA 1900 ;

GSM 1900 ;

DECT;

LTE Band 1 ,

3, 4,25;

UMTS

| Pulse

modulation 217 H z

| | 0.3| 28| 28
2450| 2400-

2570

| Bluetooth,

WLAN, 802 . 11

b /g/ n , RFID 2450, LTE

Band 7

| Pulse

modulation 217 Hz

| | 0.3| 28| 28
5240

—58

5500

5785

| 5100-

00

| WLAN

8 02. 11

a/n

| Pu lse modulation 217 Hz| 0.2| 0.3| |

Radiated RF IEC61000-4-3

(Test specifications for ENCLOSURE PORT IMMUNITY to

RF wireless communica- lions equipment)

| ****

Test Frequency (MHz)

| ****

Band (MHz)

| ****

Service

| ****

Madu- Iara

1 n

| ****

Madu-

lat1on (W)

| ****

Disla- nee (m)

| IMMU- NITY TEST LEVEL

(Vim)

---|---|---|---|---|---|---|---
1720| ****

1700-

1990

| GSM

1800; CDMA 1900; GSM 1900; DECT; LTE

Band 1,

3, 4,25; UMTS

| ****

Pulse modu- lation b) 217Hz

| ****

2

| ****

0.3

| ****

28

1845

1970

2450

| ****

2400-

2570

| Blueto-

oth, WLAN, 802,11

b/g/n, RFID 2450, LTE

Band 7

| ****

Pulse modu- lation 217 Hz

| ****

2

| ****

0.3

| ****

28

5240| ****

5100-

5800

| WLAN 802.11

a/n

| Pulse mod- ulation 217 Hz| ****

0·2

| ****

0.3

| ****

9

5500
5785

• Thank you very much for selecting the RENPHO Blood Pressure Monitor TMB-1872-B
• Please read the user manual carefully and thoroughly to ensure the safe usage of this product. Keep the manual well for further reference in case you have problems.

CONTACT

• Guangdong Transtek Medical Electronics Co., Ltd.
• Zone A, No. 105, Dongli Road, Torch Development District,
• 528437 Zhongshan, Guangdong, China

EC/REP

• Medical Device Safety Service GmbH
• Schiffgraben 41, 30175 Hannover, Germany

UK/REP

• MDSS-UK RP Ltd.
• 6 Wilmslow Road, Rusholme, Manchester M14 5TP UNITED KINGDOM
• Model: TMB-1872-B

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