moonO LC-BP01 Blood Pressure Monitor User Manual

Version:1.0
User Manual
Blood Pressure Monitor LC-BP01
Arm Type

• Thank you very much for selecting moon Blood Pressure Monitor LC-BP01.
• Please read the user manual carefully and thoroughly so as to ensure the safe usage of this product, Keep the manual well for your further reference in case you have problems.

INTRODUCTION

General Description

Thank you for selecting the moon arm type blood pressure monitor  (LC-BP01). The monitor features blood pressure measurement, pulse rate measurement, and result storage.  The design provides you with two years of reliable service.
Readings taken by the LC-BP01 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:

• 52.00mm diameter circular Digital LCD display
• Measure-during-inflating Technology
• Up to 99 pieces of a record stored per user
• Surface with a soft pillow for user measurement
• Built-in six speech and the six languages

Indications for Use
The moon Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with an arm circumference ranging from 22 cm to 32 cm (about 8¾˝-12½˝) or 22 cm to 42 cm (about 8¾˝-16½˝).
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, 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 other components.
They are the requirement of standard and use.

| The symbol for THE OPERATION GUIDE MUST BE READ”| | The symbol for “TYPE BF APPLIED N
PARTS”
---|---|---|---
| Caution: These notes must be observed to prevent any damage to the device.| | The symbol for “ENVIRONMENT PROTECTION – Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice”
| The symbol for “MANUFACTURER”
SN| The symbol for “SERIAL NUMBER”
| The symbol for “DIRECT CURRENT| | The symbol for “Class II Equipment”
| The symbol for “MANUFACTURE DATE”| | The symbol for “RECYCLE”
| For indoor use only| F1| T1A/250V (1)3.6*10CCC

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 no-invasive measuring and monitoring of arterial blood pressure.
  It is not intended for use on extremities other than the armor for functions other than obtaining a blood pressure measurement.

• Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure. Do not begin or end medical treatment without asking a physician for treatment advice.

• If you are taking medication, consult your physician to determine the most appropriate time to measure your blood pressure. Never change prescribed medication without consulting your physician.

• Do not take any therapeutic measures on the basis of a self-measurement. Never alter the dose of medicine prescribed by a doctor. Consult your doctor if you have any questions about your blood pressure.

• When the device is used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result.

• Don’t kink the connection tube during use, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the   PATIENT.

• When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus causing harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements; the application of the cuff and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a mastectomy.

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

• Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME equipment.

• On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure (cuff pressure ＞  300mmHg or constant pressure ＞ 15mmHg for more than 3 minutes) applied to the arm may lead to an ecchymosis.

• 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 81060-2:2018.

• 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 arm and fingers will become anesthetic, swollen, and even purple due to a lack of blood.

• When not in use, store the device with the adapter in a dry room and protect it against extreme moisture, 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 the 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 42.8 ℃ while the environmental temperature is 40 ℃.

• The equipment is not AP/APG equipment and is not suitable for use in the presence of a flammable anesthetic mixture with air or 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 charge power under normal circumstances and maintain the device and its accessories according to the user manual.

• To avoid measurement errors, please avoid the condition of a strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.

• The blood pressure monitor, its adaptor, and the cuff are suitable for use within the patient environment. If you are allergic to polyester, nylon, or plastic, please don’t use this device.

• During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with the requirements of ISO 10993-5:2009 and ISO  10993-10:2010.
  It will not cause any potential sensation or irritation reaction.

• The adaptor is specified as a part of ME EQUIPMENT.

• If you experience discomfort during measurements, such as pain in the arm or other complaints, press any button to release the air immediately from the cuff. Loosen the cuff and remove it from your arm.

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

• t 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).

• Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.

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

• The plug/adapter plug pins insulate the device from the main supply. Do not position the device in a position where it is difficult to disconnect from the supply mains to safely terminate the operation of ME equipment.

• The operator shall not touch the output of the batteries /adapter and the patient simultaneously.

• Cleaning: A dust environment may affect the performance of the unit. Please use a soft cloth to clean the whole unit before and after use. Don’t use any abrasive or volatile cleaners.

• The device doesn’t need to be calibrated within two years of reliable service.

• If you have any problems with this device, such as setting up, maintaining, or using it, please contact the SERVICE PERSONNEL of the moon. 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 the moon if any unexpected operations or events occur.

• Keep the unit out of reach of infants, young children, or pets to avoid inhalation or swallowing of small parts. It is dangerous or even fatal.

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

• At least 30 min required for ME equipment to warm from the minimum storage temperature between uses until it is ready for the intended use. At least 30 min required for  ME equipment to cool from the maximum storage temperature between uses until it is ready for the intended use.

• This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS;

• Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance 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/authorized 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 Signal

appears when the monitor is operated by User 2.
appears when the monitor is operated by the guest.
NOTE: User 1 and User 2, each with 99 memory spaces; User G, no memory space.

| Bluetooth transfer icon| The Bluetooth transfer icon blinks when the Bluetooth is working.
| Bluetooth transfer icon| The Bluetooth transfer icon blinks when the Bluetooth is not working.
| Battery Indicator| Indicate the current battery.
| Voice broadcast| The function of voice broadcast is turned on
****| Voice broadcast| The function of voice broadcast is turned off

Monitor Components

Component list of the pressure measuring system

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

List

1. Blood Pressure Monitor (LC-BP01)

2. AC Adapter ( Model: BLJ06L050100U-B
   BLJ06L050100U-V
   BLJ06L050100U-S
   BLJ06L050100U-U

3. User Manual

4. Cuff (22cm-32cm or 22cm-42cm)
   (Please use the moon-authorized cuff. The size of the actual cuff, please refer to the label on the attached cuff.)

BEFORE YOU START

Power Supply and Charge Power

1. The battery of LC-BP01 is a built-in rechargeable li-polymer battery, the battery current is 1000 mAh.
2. AC adaptor powered mode: 5V 1A
   Please use the AC adaptor and USB cable just like the following picture:

Charging the power under the following circumstances:

• displays on the LCD
• The LCD display is dim.
• When powering on the monitor, the LCD doesn’t light up.

CAUTION

• The battery of LC-BP01 is a built-in rechargeable lithium-ion battery, please do not disassemble it by unauthorized maintenance personnel.

• Under normal use, it can charge power about 100 times, if the battery cannot charge the power normally or the blood pressure monitor cannot use normally, please connect with the authorized maintenance personnel. If measured three times per day, and the battery is fully charged, it can be used for about 33 days.

• Storge and use the blood pressure monitor in a cool, dry, and ventilated environment. Avoid approaching the fire and the heat source, or it will cause the battery to explode.

• Only can use the moon’s authorized AC Adaptor (Model:
  BLJ06L050100U-B \ BLJ06L050100U-V \ BLJ06L050100U-S \BLJ06L050100U-U to charge the power. You cannot use the blood pressure monitor during the process of charging.

• During the process of charging, the blood pressure monitor display When the charging is finished, please pull the plugin time.

• When charging, shall not touch the charging connector and the patient simultaneously.

• Do not attempt to replace your blood pressure monitor’s battery. It is built-in and not changeable.

• Only charge the battery in accordance with the user instructions supplied with the blood pressure monitor.

• Avoid charging your blood pressure monitor in extremely high or low temperatures.

• Do not use your blood pressure monitor while you are charging it.

• Do not attempt to disassemble the blood pressure monitor or force open the built-in battery.

• Do not clean the blood pressure monitor when it is being charged. Always unplug the charger first before cleaning the blood pressure monitor.

• Do not dispose of your blood pressure monitor in a fire. The battery could explode causing injury or death.

• Batteries (battery pack or batteries installed) shall not be exposed to excessive heat such as sunshine, fire, or the like.

Setting the Time, Date, and Unit

To ensure the stored measurement result has the correct time record, please set time and unit through APP before the device is used.

Pair up the Blood Pressure Monitor with Your Device

Press and hold the voice broadcast button for 3 seconds when the device is in the state of power-on to pair up.

Bluetooth Module No.: B2075
RF Frequency Range: 2402 MHz to 2480 MHz
Output Power Range:
Supply Voltage: 3.0V to 3.6V
Transmitting Distance: 10 meters

Select the User

Press and hold the on/off button for 3 seconds when the device is in the state of power-on to select the user.

SYMBOL

|

DESCRIPTION

|

EXPLANATION

---|---|---
| User ID| appears when the monitor is operated by User 1.
| User ID| appears when the monitor is operated by User 2.
| User ID| appears when the monitor is operated by the guest.

Turn on or turn off the voice

Press the voice broadcast button shortly when the device is in the state of power-on, It will speak “ Voice on” or “Voice off ” at the same time.

SYMBOL

|

DESCRIPTION

|

EXPLANATION

---|---|---
| Voice broadcast| The function of voice broadcast is turned on
| Voice broadcast| The function of voice broadcast is turned off

Tie the Cuff

1. Remove all jewelry, such as watches and bracelets from your left arm.
   Note: If your doctor has diagnosed you with poor circulation in your left arm, use your right arm.

2. Roll or push up your sleeve to expose the skin.
   Make sure your sleeve is not too tight.

3. Hold your arm with your palm facing up and tie the cuff on your upper arm, then position the tube off-center toward the inner side of the arm in line with the little finger.  Note: Locate the main artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest.
   This is your main artery.

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

5. Sit comfortably with your tested arm resting on a flat surface. Place your elbow on a table so that the cuff is at the same level as your heart. Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths.

6. Helpful tips for Patients, especially for Patients with Hypertension:

• Rest for 5 minutes before the first measurement.

• Wait at least 3 minutes between measurements.
  This allows your blood circulation to recover.

• Take the measurement in a silent room.

• The patient must relax as much as possible and do not move and talk during the measurement procedure.

• The cuff should maintain at the same level as the right atrium of the heart.

• Please sit comfortably. Do not cross your legs and keep your feet flat on the ground.

• Keep your back against the backrest of the chair.

• 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.

MEASUREMENT

Start Measurement

1. When the monitor is off, press the ON/OFF BUTTON to turn on the monitor. (When the volume is on, it will speak “ Starting measurement, please relax” first, and then  complete the measurement process.)

Display and save the results.(When the volume is on, It will broadcast your measuring result.)

2. Press the “Start/Stop” button to power off, otherwise it will turn off within 1 minute.

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, 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.

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 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 appear.

CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually, this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

Why does my blood pressure fluctuate throughout the day?

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

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

The blood pressure is different even throughout the day due to weather, emotion, exercise, etc, Also, there is the “white coat” effect, which means blood pressure usually increases in clinical settings.

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.

TROUBLESHOOTING

If any abnormality arises during use, please check the following points:

PROBLEM| SYMPTOM| CHECK THIS|

REMEDY

---|---|---|---
No power| ****

The display will not light up.

| Power is exhausted.| Charge the power
Click the ON/OFF button, please wait for 4 seconds to turn on the device Power is low.| Don’t press repeatedly
Unable to charge| Poor contact of charging port or the adapter is not right| Please plug in the adapter again and use 5V to output the power adapter.
Error message| “Low power, please charge in time” is displayed.| Low power| Charge the power
“Fault Code E01” is displayed.| The pressure of the cuff is excess or air connector plus gets loose.| Check their connector plus, refasten the cuff.
“Fault Code E02” is displayed.| The monitor detected motion, talking or the pulse is too poor while measuring.| Relax for a moment and then measure again.
“Fault Code E03” is displayed.| The measurement process does not detect the pulse signal.| Loosen the clothing on the arm and then measure again.
“Fault Code E04” is displayed.| A calibration error occurred or out of measurement range or parameter error and so on.| Retake the measurement. If the problem persists, contact the retailer or our customer service for further assistance.
Refer to the warranty for contact information and return instructions.
Warning message| “Fault Code OUT” is displayed.| Out of measurement range| Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician.

SPECIFICATIONS

Power supply| 3.7 V 1000 mAH Built-in rechargeable li-polymer battery, 5V = 1A AC Adapter
---|---
Display mode| Digital LCD display 52.00mm diameter circular
Measurement mode| Oscillographic testing mode
| Rated cuff pressure:
0 mmHg – 299 mmHg (0 kPa – 39.9 kPa)
Measurement range| r’e,slrusroemmemnHtgPTsre2s3uornmHg (8.0 kPa- 30.7 kPa)
| DIA: 40 mmHg – 130 mmHg (5.3 kPa – 17.3 kPa) Pulse value: (40-199)beatiminute
Accuracy| Pressure:
5°C-40°C within t3 mmHg (0.4 kPa)
| Pulse value: ±5%
Normal working condition| AA treemzerahtuure range of : +5°C to +490;CA,
non-condensing, water
vapor partial pressure greater than 50 hPa
| An atmospheric pressure range of 700 hPa to 1060 hPa
Storage & transportation| Temperature: -20°C to +60°C
condition| A relative humidity range of, 93%, non-condensing, at a water vapor pressure up to 50 hPa
Measurement perimeter of the arm| About 22 cm – 32 cm or 22 cm – 42 cm
Weight| Approx. 265 g
External dimensions| Approx. 214 mm e 74.5 mm e 42 mm
Attachment| User manual, USB Cable, AC Adaptor
Mode of operation| Continuous operation
Degree of protection| Type BF applied part
| IP21 It means the device could be protected against
protection against ingress of water| solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops.
Software version| A01
| Battery Powered Mode:
Device classification| Internally Powered CE Equipment
AC Adaptor charged Mode: Class II ME Equipment

WARNING: No modification of this equipment is allowed.

AUTHORIZED COMPONENT

Authorized Component

Please use the moon authorized adapter

Adapter
Type: BLJ06L050100U-U
Input: 100-240V, 50-60Hz, 0.2A max
Output: 5V 1000mA

Contact Information

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

COMPLIED STANDARDS LIST

Complied Standards List

Risk management| EN ISO 14971:2012 / ISO 14971:2007 Medical devices – Application of risk management to medical devices
---|---
Labeling| EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labeling, and information to be supplied. Part 1: General requirements
User manual| EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices
General Requirements for Safety| EN 60601-1:2006+A1:2013+A12:2014 / IEC 60601-1:2005+A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Electromagnetic compatibility| EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests
Performance requirements| EN ISO 81060-1:2012 Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type IEC80601-2-30:2018 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Clinical investigation| ISO81060-2:2018 Non-invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type
Usability| EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
IEC 62366-1:2015 medical devices – Part 1: Application of usability engineering to medical devices
Software life-cycle processes| EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software – Software life-cycle processes
Bio-compatibility| ISO 10993-1:2018 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

EMC GUIDANCE

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 LC-BP01, 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
1 kV signal input/output 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
±0.5 kV, ±1 kV, ±2 kV common mode
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
Conducted 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 communications  equipment)

| Test Frequency (MHz)| Band (MHz)| Service| Modulation| Modulation (W)| Distance (m)| IMMUNITY
TEST LEVEL (V/m)
385| 380-390| TETRA 400| Pulse modulation b) 18 Hz| 1.8| 0.3| 27
450| 430-470| GMRS 460,
FRS 460| FM c) ± 5k Hz
deviation 1 kHz sine| 2| 0.3| 28
710| 704-787| LTE Band 13, 17| Pulse modulation b) 217Hz| 0.2| 0.3| 9
745
780
810| 800-960| GSM 800/900, TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5| Pulse modulation b) 18 Hz| 2| 0.3| 28
870
930
1720| 1700-

1990

| GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,3,
4,25; UMTS| Pulse modulation b) 217 Hz| 2| 0.3| 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
5240| 5100-

5800

| WLAN 802.11

a/n

| Pulse modulation 217 Hz| 2| 0.3| 9
5500
5785

FCC STATEMENT

FCC ID: OU9LC-BP01-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, 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.

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

References

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