TRANSTEK BB-1597-G Blood Pressure Monitor User Manual

User Manual

BB-1597-G Blood Pressure Monitor

Guangdong Transtek Medical Electronics Co., Ltd.

Revision History
NO.| Date| Update Description| Prepared| Reviewed| Approved
A/0| 2024/07/08| Initial release| Celia Li| Wendy Wang| Jerry Fan
| | | | |
| | | | |

User Manual
Blood Pressure Monitor
BB1597-G
version: A/0

• Thank you very much for selecting TRANSTEK Blood Pressure Monitor Model: BB1597-G.
• Please read the user manual carefully and thoroughtly so as to ensure the safe usage of this product,Keep the manual well for further reference in case you have problems.

INTRODUCTION

General Description
Thank you for selecting TRANSTEK blood pressure monitor (BB1597-G).
The monitor features blood pressure measurement, pulse rate measurement and the result storage.
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:

• 74.6mm×50.6mm Digital LCD display
• E-MTC wireless communication
• Three consecutive measurements
• Maximum 60 records

Indications for Use
This Blood Pressure Monitor is intended for use in measuring blood pressure and pulse rate in patients with arm circumferences from 16 ~ 36 cm (about 6⅓˝-14¹⁄5˝), 22 ~ 42 cm (about 8¾˝-16½˝), 22 ~ 45 cm (about 8¾˝-17¾˝) or 40 ~ 52cm (about 15 ¾˝ ~ 20 ½˝).
Cuff model AC1636-01, arm circumference range is 16 ~ 36cm (about 6⅓ ˝-14¹⁄5˝), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or pre-eclampsia.
Cuff model AC2245-021, arm circumference range is 22 ~ 45cm(about 8¾˝-17¾˝), which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia.
Cuff model AC2242-41 and cuff model AC4052-04, arm circumference range are 22 ~ 42cm (about 8¾˝-16½˝), and 40 ~ 52cm(about 15 ¾˝ ~ 20 ½˝) respectively, which are intended for adults without conditions of diabetes, pregnancy, or pre-eclampsia.
It is intended indoor use only.

Measurement   Principle
This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero pressure” equivalent to the atmosphere pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate.

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

| Recyclable| | Type BF applied part
---|---|---|---
| Direct Current| | Serial Number
| Date of manufacture| | Manufacturer
| Class II Equipment| | For indoor use only
| Temperature limit| | Humidity limitation
| Atmospheric pressure limitation
| Refer to instruction manual/booklet
To signify that the instruction manual/ booklet must be read.
Note: The background color of the symbol is blue.
| MR Unsafe
To identify an item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment.
| Caution
Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
| The symbol indicates that the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling.

Precaution

• Blood Pressure Monitor is intended to be operated by adults, including medical staffs and lay persons. Adult patients could also be intended users or operators.

• This device is intended for indoor, home use and is not intended for self-use in public areas.

• 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 non-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 patients who are at or over 3 years old. Do not use this device on neonates or infants.

• Consult with your physician before using this monitor if you suffer from the following conditions: common arrhythmias such as premature ventricular beats or atrial fibrillation; peripheral arterial disease, implantation with electrical devices; undergoing intravascular therapy; arteriovenous shunt or mastectomy.
  Please note that any of these conditions may affect measurement readings, in addition to patient motion, trembling or shivering.

• 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.

• 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.

• The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient environment.

• Do not wash the cuff in a washing machine or dishwasher !

• 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.

• Please choose the appropriate cuff according to your arm circumference and physical health.

Caution

• Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out byauthorized service centers.
• 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). Please contact manufacturer or distributor for authorized service personnel.
• Store your device, cuff and adapter in a clean and dry place, 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.
• Dispose of accessories, detachable parts, and the device according to the local guidelines.

Warning

• DO NOT self-diagnose the measurement results and start treatment by yourself. The measu rement results given by this device is not a diagnosis. ALWAYS consult your doctor for evalu ation of the results and treatment.

• DO NOT adjust medication based on readings from this blood pressure monitor. Take medica tion as prescribed by your physician. ONLY a physician is qualified to diagnose and treat high blood pressure.

• DO NOT apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.

• 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.

• Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries.

• DO NOT apply cuff to areas on patient where skin is delicate or damaged. Check cuff site frequently for irritation.

• 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.

• Warning: Please check (for example, by observation of the limb concerned) that the operation of the device does not result in prolonged impairment of patient blood circulation.

• 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.

• DO NOT use this device with high-frequency (HF) surgical equipment at the same time.

• This device is not used in conjunction with oxygen rich environments, not intended for use with flammable anaesthetics, not intended for use in conjunction with flammable agents.

• Excessive cuff tube lengths could cause strangulation if you don’t manage them properly.

• DO NOT touch output of the batteries/adapter and the user simultaneously.

• 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.

• DO NOT use this device if you are allergic to polyester, nylon, or plastic.

• Only use accessories approved by manufacturer. Using unapproved accessories might cause damage to the unit and injure users.

• 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.

• DO NOT use the device while under maintenance, or being serviced.

• Sensor degradation or looseness may reduce performance of device or cause other problems.

• The air tube poses a risk of strangulation. Furthermore, the small parts of product and batteries present a choking hazard if swallowed. They should therefore always be kept away from infants/children.

Notice

• You can use this device to take your own measurement, no third-party operator is required.
• Adapter is specified as a part of ME EQUIPMENT.
• 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.
• The expected lifetime of the cuff may vary by the frequency of washing, skin condition, and storage state.
• Please report to the manufacturer and the competent authority of the Member State / the FDA in which you are established about any serious incident that has occurred in relation to this device.

LCD display signal

during a measurement. Refer to page 17 for more information.
| Pluse rate| Flashes when the pulse rate is detected during the measurement.
| Blood pressure level indicator| Indicate the blood pressure level.
| Network Signal indication| Indicates the network signal situation in the communication process.
| Three consecutive measurements| Indicates the current measurement mode is three consecutive
measurements.
| Data pending to transmit icon| Appears when the data transmission failed. Up to 60 me-
asurements can be temporarily saved on the device and
send to your account when the Cellular internet is available.
| Memory Query| Indicate it is in the memory mode and
which group of memory it is.
| Warning messages| refer to page 19 for more information.

Monitor Components

List

1. Blood Pressure Monitor (BB1597-G)

2. Cuff (Type BF applied part) Upper arm cuff:16-36cm or
   Upper arm cuff:22-42cm or
   Upper arm cuff:22-45cm or
   Upper arm cuff:40-52cm.
   (Please use TRANSTEK authorized cuff.
   The size of the actual cuff please refer to
   the label on the attached cuff.)

3. 4×AA batteries

4. AC Adapter(Optional!) (BLJ06L060100P-U)

5. User manual

BEFORE YOU START

The Choice of Power Supply

1. Battery powered mode: 6V DC 4×AA batteries
2. AC adapter powered mode:
   6V 1A(Optional!)
   (Please use the AC adapter which authorized by the manufacturer!).
   Please unplug the adapter to depart from the using utility power, when you finish the measurement.

CAUTION
In order to get the best effect and protect your monitor, please use the right battery and special power adapter which complies with local safety standard.
Installing and Replacing the Batteries

• Open the battery cover.
• Install the batteries by matching the correct polarity, as shown.
• Replace the battery cover.

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 up

1. Every time when you insert or replace batteries into the device, it will start network connection, the device will try to connect to the network for 10 minutes.
   As shown on the right, it indicates that it is looking for a network.

2. If the connection is successful, the LCD will display “ ”, and it will turn off after 10 seconds automatically.

3. If the device fails to connect the network within 10 minutes, it will dispaly   and then turn off automatically.

MEASUREMENT

Applying the cuff
Only use a cuff that has been approved by the manufacturer for this device model.
Before use, please confirm if it fits your arm circumference.
Choosing for cuff:
Cuff model AC1636-01, arm circumference range is 16 ~ 36cm (6 1/3 ~14 1/5 inch), which is intended for children older than 3 years old or adults without conditions of diabetes, pregnancy, or pre-eclampsia.
Cuff model AC2245-021, arm circumference range is 22 ~ 45cm (8 ¾ ~ 17 ¾ inch) , which is intended for adult population or those who with conditions of diabetes, pregnancy, or pre-eclampsia.
Cuff model AC2242-41 and cuff model AC4052-04, arm circumference range are 22 ~ 42cm (8 ¾ ~ 16 ½ inch), and 40 ~ 52cm (15 ¾ ~ 20 ½ inch) respectively, which are intended for adults without conditions of diabetes, pregnancy, or pre- eclampsia.

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 palm facing up and tie the cuff  on your upper arm, then align the air tube toward the center of your arm.

4. Make sure the bottom edge of the arm cuff 2-3 cm  (0.8-1.2 inch) above the inside elbow. Then wrap the cuff securely.
   Note: 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 upright in a comfortable chair with your back against the backrest of the chair. Keep your feet flat and your legs uncrossed.
   Place your arm resting comfortably on a flat table.
   The cuff worn on your arm should be placed at the same level as your right atrium of the heart.

6. Take 5-6 deep breaths and let’s start measuring!
   Helpful tips to help ensure an accurate reading • Take the measurement in a silent room.
   • Rest for 5 minutes before a measurement.
   • Be relaxed, remain still and DO NOT talk while taking a measurement.
   • 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.

Start the Measurement

1. When the monitor is off, press “START/STOP” button to turn on the monitor, and it will finish the whole measurement automatically.
   (Take User 1 for example.)

2. After finishing the measurement, start the web search work and upload the measurement results.

If successful, the symbol “ ” and “ ”will disappear , and the LCD will display “ ”.
Press any button to turn off the device, otherwise it will power off automatically.

Tips:

1. You can press any button at any time to stop measuring during the process of measurement.
2. 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”.
3. If an irregular pluse rate was detected during the reading, the regular pluse rate detector indicator will appear on the display. See page 17 for more information on the irregular pluse rate detector feature.

Three consecutive measurements

1. When the monitor is off, press the “TRIPLE MEASUREMENT” BUTTON, it will enter triple measurement mode standby state (10 seconds no operation to exit).

2. Press the “START/STOP” BUTTON to start three measurements. (Take User 1 for example.)

3. When the LCD displays 1, the first measurement starts.3.
   After the measurement is completed, the device automatically deflates.
   The display does not show the measurement result and starts a 30-second countdown, then starts automatically second measurement.

4. When the LCD displays 2, the second measurement starts.4.
   After the measurement is completed, the device automatically deflates.
   The display does not show the measurement result and starts a 30-second countdown, then starts automatically third measurement.

5. When theLCD displays 3, the third measurement starts.5.
   After the three measurements are completed, it display the average of the three measurement results and uploads the data.

DATA MANAGEMENT

1. When the monitor is off, press the “MEM” button, the LCD will display the latest record.
   （The LCD will displays the number of memory groups and displays the time after 2 seconds.)

2. Press the “MEM” button again to display the next record.

3. Press the START/STOP button to turn off the monitor, otherwise it will power off automatically after about 10s.

Note

• 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.

INFORMATION FOR USER

Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances.
Maintenance
In order to get the best performance, please follow the instructions below.

1. Cleaning Process:
   Step 1: Make sure to switch off and unplug the device prior to cleaning.
   Step 2: Use a soft cloth wetted with soapy water to clean the cuff first, and then use a soft cloth wetted with clear water to remove residual soap until there is no visible residual contaminants. Attention shall be paid to avoid liquid invasion into the cuff.
   Step 3: Use a dry soft cloth to wipe the cuff, in order to remove residual moisture.
   Step 4: Dry the cuff at a well-ventilated place after cleaning.

2. Disinfection Process:
   Step 1: Make sure to switch off and unplug the device prior to disinfection.
   Step 2: Use a soft cloth wetted with 70% isopropanol to disinfect the cuff for about 3 minutes. Attention shall be paid to avoid liquid invasion into the cuff.
   Step 3: Use a clean dry cloth or towel to wipe off the disinfectant until there is no visible residue.
   Step 4: Dry the cuff at a well-ventilated place after disinfection.

• Suggestion:
  Frequency of Cleaning and Disinfection:
  For single patient multiple use, it’s recommended to clean the device surface once a month or whenever it’s necessary.
  For multiple patient multiple use, it’s recommended to clean the device every time before and after usage. Maintenance procedures shall be taken as per instruction.

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 chart on the right is the standard blood pressure classification published by American Heart Association (AHA).

This chart reflects blood pressure categories defined by American Heart Association.

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

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.

Irregular pluse rate Detector
An irregular pluse rate is detected when a pluse rate 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 pluse rate symbol will appear on the display with the measurement result.
CAUTION
The appearance of the IPR icon indicates that a pulse irregularity consistent with an irregular pulse rate 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 irregular pulse rate detector results cannot be used directly for clinical judgement. Please seek medical advice from professionals before making any medical decisions.

Why does my blood pressure fluctuate throughout the day?

1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same 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 arm?
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.
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.

TROUBLE SHOOTING

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

PRO BLEM

| SYMPTOM| CHECK THIS|

REMEDY

---|---|---|---
No power| Display will not light up.| Batteries are exhausted.| Replace with new batteries.
Batteries are inserted incorrectly.| Insert the batteries correctly.
Adapter is inserted incorrectly.| Insert the AC adapter correctly.
Low batteries| Display is dim or show | Batteries are low.| Replace with new batteries
High battery| bAtH shows| Battery voltage is too high| Please disconnect the power adapter.
Error message| E 1 + shows| The cuff is too tight or too loose.| Refasten the cuff and then measure again.
E 2 + shows| The monitor detected motion while measuring.| Movement can affect the measurement.Relax for a moment and then measure again.
E 3 + shows| The measurement process does not detect the pulse signal.| Loosen the clothing on the arm and then measure again.
E 4 + shows| Cannot calculate blood pressure| Relax for a moment and then measure again.
E 5 + shows| Abnormal communication with server or fails to transmit data.| Try a place with better signal, or contact customer service.
E 6 + shows| Cannot connect to the Internet.| Contact customer service.
E 8 + shows| SIM card detection failed (detected 3 times).| Turn off monitor and measure again. If E8 still appears on the display, please contact the retailer or our customer service.
EEx + , shows on the display.| 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.
shows| Out of measurement range| Relax for a moment and then measure again.

SPECIFICATIONS

Power supply| Battery powered mode: 6VDC 4xAA batteries AC adapter powered mode: 6V 1A (Optional) (Please only use the recommended AC adapter model).
---|---
Display mode| Blue LCD with white backlight V.A.73mmx49mm
Measurement mode| Oscillographic testing mode
Measurement range| Rated cuff pressure:
OmmHg-299mmHg
Measurement pressure:
SYS: 60mmHg-230mmHg
DIA: 40mmHg-130mmHg
Pulse value: (40-199)beat/minute
Accuracy| Pressure:
5 C -40 C within±3mmlig 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
A relative humidity range of 5 93%, non-condensing, at a water vapour pressure up to 50hPa
An atmosphere pressure range of:
500hPa to 1060 hPa
Measurement perimeter
of the upper arm| About 16-36cm, 22-42cm, 22-45cm or 40-52cm
Weight| Approx.274g(Excluding the batteries and cuff)
External dimensions| Approx.118mm x 126mm x 72mm
Attachment| 4xAA batteries, adapter, 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| Powered Mode:
Battery Internally Powered ME Equipment
AC Adapter Powered Mode: Class II ME Equipment
Software Version| A01

ATHORIZED COMPONENT

Expected Lifetime| Device: 2 years or 10,000 measurements (may vary based on usage conditions)
Cuff: 10,000 times
Alkaline battery: About 200-300 times
Adapter: About 20,000 hours
---|---
Types of use/reuse| Multiple patient multiple use

WARNING: No modification of this equipment is allowed.
Authorized Component
Please use the TRANSTEK authorized adapter. (Optional!)

Adapter
Model：BLJ06L060100P-U
Input：AC 100-240V
50/60Hz 0.2A Max
Output : 6V 1000mA

Contact Information
For more information about our products, please visit www.transtekcorp.com.
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 Statement
FCC ID: OU9BB-1597-G
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 equipment should be installed and operated with minimum distance 20cm between the radiator and your body. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
FCC Responsible Party
Name: MIO LABS INC.
Address: #1023, ZGC Innovation Center, 4500 Great America Pkwy, Santa Clara, CA 95054
Telephone: 301-910-0529
E-mail: mio@transtekcorp.com

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 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 PERFOR- MANCE with regard to electromagnetic disturbances for the expected lifetime.
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
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

SPECIFICATIONS FOR 4G

Specifications for 4G

Specifications for 4G

E-MTC| Supporting band：| Cat-M1:
B2/4/12/13/25
Transmitted frequency range| 1850—1910MHz,
1710—1755MHz,
699—716MHz,
777—787MHz,
1850—1915MHz
Transmitted power| 20±2dBm
Throughput| 588~1119 kbps
Latency| ≤21ms
Jitter| ≤21ms
PER| ＜5%
Data Integrity| Data shall be transmitted correctly and completely
Accessibility| Accessibility is high since 4G is broadband
Remark:
1. The Quality of Service (QoS) is considered as KPIs here.
2.  For the Blood Pressure Monitor，the E-MTC is used to transmit the control data between the EUT and the controller,the manufacture considered 375~1119 kbps is a suitable throughput for the usage
3. The PER of the wireless system is normally less than 1%, for Semi-anechoic chamber, we considered the PER cannot be greater than 10%.
4.  Use the wireless module which the EUT used as the test model,instead the EUT.

Warning
Failure to comply with the following warnings may cause cybersecurity issues.
DO NOT casually use the blood pressure monitor for others, as it may lead to leakage of personal measurement data.
DO NOT connect the blood pressure at places with poor network or wireless connectivity.
as it may interrupt data upload and lead to deficient data.

Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development District,
528437 Zhongshan, Guangdong, China
version:A/0

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