TRANSTEK TMB-1598-BS Wrist Blood Pressure Monitor User Manual

TRANSTEK TMB-1598-BS Wrist Blood Pressure Monitor

INTRODUCTION

General Description
Thank you for selecting TRANSTEK Blood Pressure Monitor (TMB-1598-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-1598-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:

• Systolic blood pressure
• Diastolic blood pressure
• Pulse rate
• 60 records for one user

Indications for Use
The Transtek Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging from 13.5cm to 21.5 cm ( about 5⅓˝-8½˝ ). It is intended for adult indoor use 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 use on 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 point” equivalent to the atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to determine the systolic pressure and diastolic pressure as well as pulse rate.

Safety Information
The signs below might be in the user manual, labeling, or another component. They are the requirement of the standard and use.

CAUTION

• This device is intended for adult use in homes only.

• The device is not suitable for use on neonatal patients, pregnant women, patients with implanted, electronic 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.

• 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 wrist 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 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.

• Warning: Do not apply the cuff over a wound; otherwise it can cause further injury.

• Do not inflate the cuff on the same limb that 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 wrist may lead to an ecchymosis.* 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 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 wrist 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 maximum temperature that the applied part can be achieved is 42.5℃ while the environmental temperature is 40℃.

• 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 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 requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensation or irritation reaction.

• If you experience discomfort during a measurement, such as pain in the wrist or other complaints, press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from your wrist.

• If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressure reaches 40 kPa (300 mmHg), detach the cuff from the wrist 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.

• It is recommended that the performance should be checked every 2 years and 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).

• The manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions,etc., to assist to service personnel in parts repair.

• The operator shall not touch output of batteries 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. 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, please contact the SERVICE PERSONNEL of Transtek. 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 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.

• Be careful to strangulation due to cables and hoses, particularly due to excessive length.

• At least 30 min required for ME equipment to warm from 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 telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance 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 parts specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.

• There is no luer lock connectors are used 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 provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.

LCD Display Symbol

Monitor Components

Component list of pressure measuring system:

1.  PCBA;
2.  Air Pipe;
3.  Pump;
4.  Valve;
5.  Cuff.

List

1. Blood Pressure Monitor TMB-1598-BS
2. 2×AAA batteries
3. User manual

BEFORE YOU START

Installing and Replacing the Batteries

• Slide off the battery cover.
• Install the batteries by matching the correct polarity, as shown below. Always use the correct battery type (2×AAA batteries.)
• Replace the cover.

The typical service life of the new and unused batteries is 54 measurements for the operation time is 60s.

Replace the batteries whenever the below happens

• The 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 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. Remove the old batteries from the device following your local recycling guidelines.

Setting Date, Time, Positioning Symbol and Measurement Unit
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 year is 2016 ~ 2056. Time format: 24H)

1. When the monitor is off, press “ ” button, it will display the time. Then press and hold “ ” button to enter the mode for year setting.
   Notes:

2. During the process of setting, you can press “ ” button to stop setting at any time.

3. If there is no operation during the process of setting, it will turn off within 1 minute.

4. Press “ ” button to change the [YEAR]. Each press will increase the numeral by one in a cycling manner.

5.  When you get the right year, press “ ” button to confirm nd it will turn to next step.

6. Repeat step 2 and 3 to confirm [MONTH] and [DAY].

7.  Repeat step 2 and 3 to confirm [HOUR] and [MINUTE].

8. Repeat step 2 and 3 to confirm [Positioning symbol] on or off.

9. Repeat step 2 and 3 to confirm the measurement unit.

10. After confirming the measurement unit, the LCD will display “Done”, then display all the settings you have done one by one and then the monitor will turn off.

Select the User ID

Before you start the measurement, please select the desired user ID first.

1. When the blood pressure monitor is off, press and hold “ ” button until  the user ID blinks. Then press “ ” button to change the user ID between user 1 and user 2. Press “ SET ” button to confirm your selection.
2. After confirming the user ID, the LCD will display “ User ID+donE ” and then turn off.

Pair up the Blood Pressure Monitor with Your Device

1. Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding.
2. When the monitor is OFF, press and hold the “ ” button to  start pair-up. The symbol “ ” and will be shown on the LCD alter indicating pair-up is proceeding.
   • If SUCCEED, the symbol “ + [ ] ” will be shown on the LCD.
   • If FAIL, the symbol “ + ” will be shown on the LCD.
3. The monitor will shut off automatically after Pair-up process is complete.

• Bluetooth Module No: LS51802
• RF Frequency Range: 2402 MHz to 2480 MHz
• Output Power Range: -2.51 dBm
• Supply Voltage: 2 V to 3.6V
• Transmitting Distance: 10 meters

MEASUREMENT

Tie the Cuff

1. Remove all accessories (watch, bracelet,etc) from your wrist. If your physician has diagnosed you with poor circulation in your wrist, use the other one.
2. Roll or push up your sleeve to expose the skin.
3. Apply the cuff to your wrist with your palm facing up.
4. Position the edge of the cuff about 1cm~1.5cm from wrist joints.
5. Fasten the wrist cuff around your wrist, leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will not be accurate.
6. Sit comfortably with your tested wrist 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.
7. Patients with Hypertension:
   The middle of the cuff should be at the level of the right atrium of the heart; Before starting measurement, please sit comfortably with legs uncrossed, feet flat on the floor, back and wrist supported. Rest for 5 minutes before measuring. 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 do not move and talk during the measurement procedure. The cuff should maintain at the same level as the right atrium of the heart. Do not cross your legs and keep your feet on the ground. Keep your back against the backrest of the chair. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same wrist, or as directed by a physician.

Start the Measurement

1. When the monitor is off, press “ ****” button to turn on the monitor, and it will finish the whole measurement. (Take user 1 for example.)

2. After finishing the measurement, the LCD displays the blinking icon ‘ **’,and transmits the data.
   Note:**

3. The symbol “ ! ” will disappear after successful data transmission, and you may check your personal health data stored in your mobile device.

4. If the data transmission fails, the symbol “ ! ” will remain. The pending measurement data will be transmitted to your mobile device when next measurement is complete.

5.  If you have set the [Positioning Symbol] on, when you start the measurement, the blood pressure monitor will detect the position first. The wrist must beat the angle between 30°and 45°. If it’s out of this angle, the LCD won’t start any measurements and will display blinking symbol “ ” until you have the correct position. If you get the correct position, it will display “ ” for about 3 seconds, and then finish the whole measurement.

6. During the measurement or when the measurement is finished, press “ **”button to turn off the monitor. Otherwise it will power off in one minute.
   Tips:**

7.  There are two users in total. Each user has 60 records.

8.  You can press “ ****” button to stop measuring during the process of the measurement at any time.

9.  If the measurement result is out of the measurement range (SYS: 60mmHg to 230mmHg; or DIA: 40mmHg to 130mmHg;or Pulse: 40-199 pulse/minute), the LCD will display “out”.

CAUTION

• Interference may occur in the vicinity of equipment marked with the following symbol . And  TMB-1598-BS may interfering vicinity electrical equipment.
• Sensitive people, including pregnant women pre-eclamptic and those who implanted medical electronic instruments, should avoid using the unit whenever possible.
• Keep the monitor at least 20 centimeters away from the human body (especially the head) when the data transmission is proceeding after measurement.
  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.

DATA MANAGEMENT

Recall the Records

1. When the monitor is off, press “ ****” button to show the average value of the latest three measurement records. If the records are less than 3 groups, it will display the latest record instead.
2. Press “ ” button or “ ” button to get the record you want.
3. If you want to check the other user’s measurement records, please press “ ” button to turn off the blood pressure monitor. Then press and hold “ ” button to enter the selecting user mode, press “ ” again to change the user, when the desired user ID blinks, press “ ” button to confirm. Then press“ ****” button to check the records of the selected user.

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 (60) is dropped from the list.

Delete the Records

If you did not get the correct measurement, you can delete all the results for the selected user by following steps. (Take user 1 for example.)

1. Hold pressing “ ****” button about 3 seconds when the monitor is in the memory recall mode , the “dEL All” +User ID will flash on the display.

2. Press “ ” button to confirm,the LCD displays “ User ID+dEL donE” and then turns off.
   Note: To exit out of delete mode without deleting any records, press “ ****” button before pressing “ ” button to confirm any delete commands.

3.  If there is no record, press “ ****” button the below display will be shown.

INFORMATION FOR USER

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

Maintenance
To obtain the best performance, please follow the instructions below.

ABOUT BLOOD PRESSURE

• What are systolic pressure and diastolic pressure?
  When ventricles contract and pump blood out of the heart, blood pressure reaches its maximum value, the highest pressure in the cycle is known as systolic pressure. When the heart relaxes between heartbeats, the lowest blood pressure is diastolic pressure.

• 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).Blood Pressure Category| Systolic

mmHg (upper#)

| | Diastolic

mmHg (lower#)

---|---|---|---
Normal| less than 120| and| less than 80
Elevated| 120-129| and| less than 80
High Blood Pressure

(Hypertension) Stage 1

| 130-139| or| 80-89
High Blood Pressure

(Hypertension) Stage 2

| 140 or higher| or| 90 or higher
Hypertensive Crisis

Consult your doctor immediately)

| Higher than 180| and/or| Higher than 120

• 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, 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.

• 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.

• Is the result the same if measuring on the right wrist?
  It is ok for both wrists, but there will be some different results for different people. We suggest you measure the same wrist every time.

TROUBLESHOOTING

This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the product is not operating as you think it should, check here before arranging for servicing.

No power

|

Display is dim or will not light up.

| Batteries are exhausted.| Replace with new batteries
Batteries are inserted incorrectly.| Insert the batteries correctly
Low batteries| Show on the display|

Batteries are low.

|

Replace with new batteries

Error message

|

E 01 shows

| The cuff is too tight or too loose.| Refasten the cuff and then measure again.
E 02 shows| The monitor detected motion, while measuring.| Relax for a moment and then measure again.
E 03 shows| The measurement process does not detect the pulse signal.| Loosen the clothing on the arm and then measure again.
E 04 shows| Measure incorrectly.| Relax for a moment and then measure again.

+ Err shows

|

The wrist angle is not correct

| The wrist must beat the angle between 30° and 45° when you have set the [Positioning Symbol] on, .
PROBLEM| SYMPTOM| CHECK THIS| REMEDY
---|---|---|---
Error message|

EExx,shows on the display.

| A calibration error occurred. (XX can be some digital symbol,such as 01,02,etc.,

if this similarsituation appear,

all belong to calibration error.)

| Retake the measurement.If the problem persists,contact the retailer or our customer service department for further assistance. Refer to the warranty for contact information and return instructions.
Warning message|

out shows

|

Out of measurement range

|

Relax for a moment. Refasten the cuff and thenmeasure again. If the problem persists, contact your physician.

SPECIFICATIONS

IP Classification

| IP22: The first number 2: Protected against solid foreign objects of 12,5mm Ф and greater. The second number: Protected against vertically falling water drops when enclosure titled up to 15º. Vertically falling drops shall have no harmful effects when the enclosure is titled at any angle up to 15º on either side of the vertical.
Software Version| A01

WARNING: No modification of this equipment is allowed.

Contact Information

For more information about our products, please visit www.transtekcorp.com.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 A, No.105 ,Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong,China

FCC Statement

FCC ID: OU9TMB1598B2
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, including interference that may cause
undesired operation.
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 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.

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.

EMC GUIDANCE

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments
Warning: Don’t near 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 electromagnetic 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-1598-BS, 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| Not application
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Not application

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, ±4kV, ±8 kV, ±15 kV air

| ±8 kV contact

±2 kV, ±4kV, ±8 kV, ±15 kV air

Electrical fast transient/burst IEC 61000-4-4| Not applicable| Not applicable
Surge IEC61000-4-5|

Not applicable

|

Not applicable

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| Not applicable| Not applicable
---|---|---
Power frequency magnetic field IEC 61000-4-8| 30 A/m

50Hz/60Hz

| 30 A/m

50Hz/60Hz

Conduced RF IEC61000-4-6| Not applicable| Not applicable
Radiated RF IEC61000-4-3| 10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

| 10 V/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

Guidance and manufacturer’s declaration – electromagnetic Immunity

Radiated RF IEC61000-4-3

(Test specifications for ENCLOSURE PORT IMMUNITY to

RF wireless communicati- ons equipment)

| Test Frequency (MHz)| Band

(MHz)

| Service| Modulation| Maximum Power (W)| Distance

(m)

| IEC 60601-1-2

Test Level

(V/m)

| Compliance level

(V/m)

385| 380-390| TETRA 400| Pulse modulation 18 Hz| 1.8| 0.3| 27| 27
450| 430-470| GMRS 460,

FRS 460

| FM ± 5k Hz

deviation 1 kHz sine

| 2| 0.3| 28| 28
710| 704-787| LTE Band 13,

17

| Pulse modulation 217 Hz| 0.2| 0.3| 9| 9
745
780
810| 800-960| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

| Pulse modulation 18 Hz| 2| 0.3| 28| 28
870
930
| 1720| 1700-

1990

| GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1,

3, 4,25; UMTS

| Pulse modulation 217 Hz| 2| 0.3| 28| 28
---|---|---|---|---|---|---|---|---
1845
1970
2450| 2400-

2570

| Bluetooth, WLAN, 802.11

b/g/n, RFID 2450, LTE

Band 7

| Pulse modulation 217 Hz| 2| 0.3| 28| 28
5240| 5100-

5800

| WLAN 802.11

a/n

| Pulse modulation 217 Hz| 0.2| 0.3| 9| 9
5500
5785

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