Oak 2088 Dual Users Arm Blood Pressure Monitor User Manual

June 17, 2024
OAK

Oak 2088 Dual Users Arm Blood Pressure Monitor

Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-
product

Device Overview

Indications for Use

This Blood Pressure Monitor Meraw Oak is a digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 42 cm (about 8¾˝-16½˝). It is intended for indoor, adult use only.

Contraindications

  1. The device is not suitable for use on the women who are or may be pregnant.
  2. The device is not suitable for use on patients with implanted electrical devices, such as cardiac pacemakers, and defibrillators.

Safety Information

  • The signs below might be in the user manual, labeling or other component.
  • They are the requirement of standard and using.

Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-fig-1

Monitor Components

Component list of pressure measuring system

Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-fig-2

  1. CUFF
  2. AIR HOSE
  3. AIR CONNECTOR PLUG
  4. LCD DISPLAY
  5. BLUETOOTH
  6. USER B
  7. USER A/ STOP
  8. TYPE-C POWER SOCKET

Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-fig-3

List

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LCD Display

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SYMBOL          DESCRIPTION          EXPLANATION

| User ID| User A & User B
   NORMAL| Normal BP| The blood pressure reading is Normal
 ELEVATED| Elevated BP| The blood pressure reading is Elevated
   STAGE 1| Stage 1 BP| The blood pressure reading is Stage 1
   STAGE 2| Stage 2 BP| The blood pressure reading is Stage 2
     CRISIS| Crisis BP| The blood pressure reading is Crisis

Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-fig-6

Operation

Button| | | |
---|---|---|---|---
OPERATION| SHORT CLICK| LONG PRESS| SHORT CLICK| LONG PRESS| SHORT CLICK| LONG PRESS| LONG PRESS
THE MONITOR IS OFF| Enter Bluetooth pairing| –| Start measuring for User B| Recall records for User B| Start measuring for User A| Recall records for User A| –
SET DATE AND TIME| Confirm selection| –| Forward| –| Backward| –| –
DURING MEASUREMENT| –| –| Stop measuring and deflate| Stop measuring and deflate| Stop measuring and deflate| Stop measuring and deflate| –
RECALL RECORDS| Power off| Delete a single record| Forward| –| Backward| –| Delete

all records

DELETE RECORDS| Confirm selection| –| Switch between yes and no| –| Switch between yes and no| –| –

Device Set Up

Power Supply

Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-fig-8

  1. Battery powered mode: 6V DC 4× AA batteries
  2. AC adapter powered mode: 5V 1A

CAUTION

  • In order to get the best effect and protect your monitor, please use the right batteries and special power adapter which complies with local safety standard.

Installing Batteries

  1. Open the battery cover;
  2. Install the batteries by matching the correct polarity, as shown;
  3. Replace the battery cover.

Replace the batteries whenever the below happen

  • The bAt Lo+ shows.
  • The display is dim.
  • The display does not light up.

Setting Date and 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.
  • (Year: 2023—2053 Time format: 12H)

Auto Setting

  • Once connected to smartphone App via Bluetooth, date and time will be synced to BPM automatically.

Manual Setting

  1. When the monitor is off, press and hold the “Bluetooth ” button to display the year. Press the “User A” or “User B” button to select the right year, then press “Bluetooth” to confirm.
  2. Press the “User A” or “User B” button to select the right month and day, then press “Bluetooth” to confirm.
  3. Press the “User A” or “User B” button to select the right HOUR and MINUTE, then press “Bluetooth” to confirm.
  4. After the minute is set, the LCD will display “do nE” and then it will turn off.

Pair With A Smart phone

Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-fig-12

  1. When the monitor is off, press “Bluetooth” button.
  2. The Bluetooth icon will blink in the screen.
  3. Click “Start connection” on Meraw Health App.
  4. Wait for pairing complete automatically.

Measurement

Tie The Cuff

Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-fig-13

  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 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 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.
  4. The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm.

Sit Correctly

Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-fig-14

  • 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.

Start The Measurement

Notes

  • To stop the measurement, press the User A or User B button once to defalte the arm cuff.
  • Remain still and quiet while taking a measurement.

Press the User A or User B button

Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-fig-15

  • The arm cuff will start to inflate automatically.
  • The whole measurement takes around 35 seconds.

Measurement Tips

  • 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.
  • The user 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.
  • Keep your back against the backrest of the chair.
  • Please sit comfortably. Do not cross your legs and keep your feet flat on the ground.
  • For a meaningful comparison, try 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.

Bluetooth & App

Download App

  • Meraw Health app is available both on Google play and App Store, search and download.
  • Make sure your phone has enough storage and meet lowest system version requirement before downloading.

Scan above QR code to download App and get App instruction.

  • Android system: Android 9.0 or above

  • iOS system: iOS 10.0 or above

Add My Device

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Step 1. Add device

  1. Turn on Meraw Health App;
  2. Click “Add device”;

Step 2. Choose device

  • Select “Meraw Oak” in the model list;

Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-fig-20

Step 3. Start Connection

  1. The monitor is power off;
  2. Long press bluetooth button until Bluetooth icon blinks;
  3. Make sure to authorize permission and enable bluetooth and location in the phone;
  4. Click “start connection”;

Step 4. Connection successfuly

  • The connection process will complete automatically
View Data

Data list

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  • Turn on the App after measurement, the result will be synced to the App automatically.
  • The records will be shown in the data list.

Track trends

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  • The data will show in trend by week/ month/quarter, track the history at a glance.

Share Records

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  • Export record as a graph or via CSV. file, send it to the family or the doctor.

Add remark

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  • Some factors may influence the accuracy of measurement, select a data and add remark on it.

Data Management

Recall the records

  1. When the monitor is off, long press “User A” or “User B” button, the display will show the average value of the latest three records first.
  2. When the memory record is less than three groups, the display will show the latest record (memory record 01)
  3. Press “User A” or “User B” button to get the record you want.
    • Each press “User A” button will decrease the memory record by one in a cycling manner (AVG-01-02…).
    • Each press “User B” button will increase the memory record by one in a cycling manner (AVG-…-02-01).

Sync the records

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  1. Turn on Bluetooth and open App on your smartphone before you sync the records.
  2. Each time you complete a measurement, data will be synced to App automatically,the bluetooth icon will disappear.
  3. Each time you recall the blood pressure records, it will upload the data you haven’t synced automatically, once synced, the Bluetooth icon will disappear in the result page.

Delete the records

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

To delete a single measurement:

  1. Enter the memory recall mode as described in section [Recall the Records]. Press “User A” or “Uers B” button to get the measurement you would like to erase.
  2. Press and hold “Bluetooth” button for 3 seconds, and the display will show a blinking “dEL oK”.Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-fig-28
  3. Use the “User A” or “User B” button to toggle between “dEL oK” and “dEL no”, Press “Bluetooth” to confirm the selection. If “dEL oK” is selected, the unit will delete the record. After then it will return to last memory record and All the records are pushed forward one digit (e.g., 03 becomes 02, and so on) If “dEL no” is selected, it will stop the deletion.

To delete all measurements:

  1. Enter the memory recall mode as described in section [Recall the Records].
  2. Press and hold “User A” and “Uers B” button for 5 seconds, and the display will show a blinking “dEL AL” .
  3. Use the “User A” or “User B” button to toggle between “dEL AL” and “dEL no”, Press “Bluetooth” to confirm the selection.

If “dEL AL” is selected, the unit will display “dEL do nE” and delete all the record of the current user. Several seconds later, it will display “—”.
If “dEL no” is selected, it will stop the deletion.

About blood pressure

Systolic pressure and diastolic pressure

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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.

Standard blood pressure classification

The blood pressure classification published by AAC/AHA in 2017 is as follows:

CAUTION

  • Only a physician can tell your normal BP range.Please contact a physician if your measuring result falls out of the range.
  • Please note that only a physician can tell whether your blood pressure value has reached a dangerous point.

Healthy and unhealthy blood pressure ranges

BLOOD PRESSURE CATEGORY| SYSTOLIC mm Hg

(upper number)

| and/or| DIASTOLIC mm Hg

(lower number)

---|---|---|---
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 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 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%, the irregular heartbeat symbol appears on the display when the measurement results are appeared.

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 not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

Blood pressure fluctuate throughout the day

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  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 conditions.
  2. If the person takes medicine, the pressure will vary more.
  3. Wait at least 3 minutes for another measurement.

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.

Measuring on the right arm

Oak-2088-Dual-Users-Arm-Blood-Pressure-Monitor-fig-31

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

Information

Trouble Shooting

PROBLEM SYMPTOM CHECK THIS REMEDY

No power

|

Display can not light up.

| Batteries are depleted.| Replace with new batteries.
Batteries are inserted incorrectly.| Insert the batteries correctly.
Adapter is inserted incorrectly.| Insert the AC adapter correctly.
High Battery| bAt H shows| The battery is too high.| Replace with new batteries.
Low Battery| bAt Lo + shows| The battery is too low.| Replace with new batteries.

Error message

| E 01 shows| The cuff is not wrapped or wrapped incorrectly, or the cuff air plug is loose.| Refasten the cuff and insert air tube plug correctly then measure again.
E 02 or

shows

| Excessive body motion (such as shaking of the arm with the cuff on)

or weak Pulse is detected.

| Relax for 5 minutes. and then keep still, measure again.
E 03 shows| Pulse is not detected during measuring.| Loosen the clothing on the arm and measure again.
E 04 shows| The measurement failed.| Relax for 5 minutes and measure again.
EEx shows| Hardware error

(X can be some digital symbol, such as 1, 2, 3, etc.)

| Turn off monitor and measure again. If EEx still appears on the display, please contact the retailer or our customer service.
Err & Usb shows| Adapter error| Replace with the authorized adapter.
Warning message| out shows| Out of measurement range| Relax for a moment and then measure again. If the problem persists, contact your physician.

Specification

Power supply

| Battery powered mode: 6VDC 4×AA batteries AC adaptor powered mode: 5V 1A

(Please only use the recommended AC adaptor model).

---|---
Display mode| Digital LCD V.A.124mm × 76mm
Measurement mode| Oscillographic testing mode
Measurement range| Rated cuff pressure: 0mmHg~299mmHg Measurement pressure:

SYS: 60mmHg~230mmHg DIA: 40mmHg~130mmHg

Pulse value: (40-199)beat/minute

Accuracy| Pressure:5℃-40℃within±3 mmHg Pulse value:±5%
Normal working condition| A temperature range of :+5°C to +40°C A relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapour partial pressure greater than 50 hPa

An atmospheric pressure range of : 700 hPa to 1060 hPa

Storage & transportation condition| Temperature:-20°C to +60°C at a water vapour pressure up to 50 hPa
Measurement perimeter of the upper arm| About, 22 cm ~ 42 cm
Weight| Approx.318g (Excluding the batteries and cuff)
External dimensions| Approx.174mm×100mm×41mm
Attachment| 4×AA batteries,user manual
Mode of operation| Continuous operation
Degree of protection| Type BF applied part
Protection against ingress of water| IP21 It means the device could protected against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops.
Device Classification| Battery Powered Mode:

Internally Powered ME Equipment

AC Adaptor Powered Mode: Class II ME Equipment

Software Version| A01

WARNING

  • No modification of this equipment is allowed.

Product Maintainance

CAUTION

  • This device is intended for indoor, home use.
  • This device is not intended for public use.
  • This device is portable, but it is not intended for use during patient transport.
  • This device is not suitable for continuous monitoring during medical emergencies or operations.
  • This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm, or for any purpose other than obtaining a blood pressure measurement.
  • This device is for adults. Do not use this device on neonates or infants. Do not use it on children unless otherwise instructed by a medical professional.
  • Do not use on the women in pregnant, including pre-eclamptic, patients.
  • The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, defibrillators.
  • The effectiveness of this device has not been established for use:
    • on users with common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation,
    • on users with peripheral arterial disease,
    • on users undergoing intravascular therapy, or with arteriovenous (AV) shunt.
  • Consult a medical professional before use.
  • Do not use this device for diagnosis or treatment of any health problem or disease. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or health care professional.
  • If you are taking medication, consult your physician to determine the proper time to measure your blood pressure.
  • This device may be used only for the intended use described in this manual, the manufacturer shall have no liability for any incidental, consequential, or special damages caused by misuse or abuse.
  • Report any unexpected operation or events to the manufacturer.
  • Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.
  • Warning: Do not kink, fold, stretch, compress, or otherwise deform the tube during measuring, as the cuff pressure might continuously increase, which could prevent blood flow and result injury.
  • Warning: Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries.
  • Warning: Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site frequently for irritation.
  • Warning: Do not place the cuff on the arm of a person whose arteries or veins are undergoing medical treatment, i.e. intra-vascular access or intra-vascular therapy or an arteriovenous (A-V) shunt, which could disrupt blood circulation and cause injuries.
  • Do not place the cuff on the arm on the same side of a mastectomy (especially when lymph nodes have been removed). it is recommended to take measurements on the unaffected side.
  • Do not wrap the cuff on the same arm to which another monitoring device is applied. One or both devices could temporarily stop functioning if you try to use them at the same time.
  • Please check that the operation of the device do not result in prolonged impairment of patient blood circulation.

CAUTION

  • Warning: On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, loosen and remove the cuff immediately. Prolonged high pressure applied to the arm (cuff pressure >300 mmHg or constant pressure >15 mmHg for more than 3 minutes) might lead to bruising and discolored skin.
  • Warning: Do not use this device with high-frequency (HF) surgical equipment at the same time.
  • Warning: This device is not AP/APG equipment. Do not use the device where flammable anesthetic are present, or in environments mixture with air of with oxygen or nitrous oxide.
  • The device contains sensitive electronic components.To avoid measurement errors, avoid taking blood pressure measurements near a strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.
  • Wireless communication equipment, such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies may cause interference that may affect the accuracy of measurements. A minimum distance of 1 foot (30 cm) should be kept from such devices during a measurement.
  • You can use this device to take your own measurement, no third-party operator is required.
  • 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.
  • The device may require up to 30 minutes to warm up / cool down from the minimum / maximum storage temperature before it is ready for use.
  • Warning: Excessive cuff tube lengths could cause strangulation if you don’t manage them properly.
  • Warning: Do not touch output of the batteries/adapter and the user simultaneously.
  • Adapter is specified as a part of ME EQUIPMENT.
  • Warning: The power cord is considered the disconnect device for isolating this equipment from supply mains. Do not position the equipment so that it is difficult to reach or disconnect.
  • The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient environment.
  • Warning: Do not use this device if you are allergic to polyester, nylon, or plastic.
  • Warning: Only use accessories approved by manufacturer. Using unapproved accessories might cause damage to the unit and injure users.
  • Warning: If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the Power button immediately to release the air from the cuff.
  • No calibration is required within two years of reliable service.
  • Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out by authorized service centers.
  • At the request of authorized service personnel, circuit diagrams, component part lists, descriptions, and calibration procedures will be made available by the manufacturer or distributor.
  • It is recommended that the performance should be checked after repair, maintenance, and every two years of use, by retesting the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50 mmHg and 200 mmHg).
  • Warning: Do not use the device while under maintenance, or being serviced.
  • Store your device, cuff and adapter in a clean and dry place, and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on it.
  • Make sure the rubber tube of the cuff is not squeezed, stretched, or kinked during storage.
  • Warning: Keep the device, cuff, and batteries away from children as they may pose a risk of choking or strangulation if used improperly.
  • Clean both device and cuff with a soft, dry cloth. If necessary use a dampened cloth and natural detergent. Do not use alcohol, benzene, or other harsh chemicals.
  • 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.
  • Dispose of accessories, detachable parts, and the device according to the local guidelines.

FCC Statement

FCC ID: OU9TMB2088-B

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,
  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 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 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-2088-C 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 A/m

50 Hz / 60 Hz

| 30 A/m

50 Hz / 60 Hz

Conduced RF IEC61000-4-6

| 3 V

0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands between 0, 15 MHz and 80 MHz

80% AM at 1 kHz

| 3 V

0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands between 0, 15 MHz and 80 MHz

80% AM at 1 kHz

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

ENCLO- SURE 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 ± 5kHz

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

Contact

Distributor

  • Meraw Labs Inc.
  • 4500 Great America Pkwy, Santa Clara, CA 95054

Manufacturer

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

Global Customer Service

References

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