NINGBO RN1l, RN1L Pro Arm Blood Pressure Monitor User Manual

NINGBO RN1l, RN1L Pro Arm Blood Pressure Monitor

FAQ

• Q: Can this blood pressure monitor be used for pregnant women?
  • A: No, this product is not suitable for use in pregnancy. It is recommended for adult use only.
• Q: Does the blood pressure monitor have a voice broadcast function?
  • A: Yes, the blood pressure monitor features an optional voice broadcast function for operation tips during measurement and memory recall.

Before using this product, please read the user’s manual carefully and use it accordingly. Please keep the user’s manual properly for reference at any time.
(The pictures in this manual are for reference only)

Preface

Dear user:

Thank you for choosing our blood pressure monitor. Before using this blood pressure monitor, please read the user’s manual carefully and use it accordingly. Please keep the user’s manual properly for reference at any time. The electronic blood pressure meter can be used in hospitals, schools medical centers and also in families. It is suitable for adult, not for neonate or pregnancy.

Product Brief Introduction:

• The full name of this product is arm-type electronic blood pressure monitor. It consists of the main body and the arm belt, suitable for human blood pressure and pulse measurement.
• The blood pressure monitor adopts the intelligent pressure method, which can adjust your blood pressure to a suitable value automatically according to your own blood pressure value. It can effectively reduce the discomfort caused by incorrect pressure, shorten the measurement time and prolong the service life of the arm at the same time.
• This blood pressure monitor has the memory function of 60 groups of measuring data of two people, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.
• This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.
• This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.

Safety Precautions

The patient expects to be the operator.

Warnings and graphic symbols in the user’s manual will enable users to use the product safely and correctly in order to avoid any damage to users and the others. Specific meanings are as follows:

Symbol Descriptions

CAUTION

• Patients of arrhythmia, diabetes, poor blood circulation or stroke, please use the product under the guidance of a doctor
• It is very dangerous for the patients to make self-judgment and self-treatment according to the measurement results. Please follow the guidance of the doctor, self-judgment is likely to deteriorate the patient’s condition.
• There may be a risk, such as arm numbness or pain that may be caused by over inflation of the gas bag.
• For the sake of safety, please keep the product in the place where the child is not easy to touch.
• Infants and children who cannot express their thoughts are prohibited to use the product, because they will be the cause of the accident or dispute.
• Do not use the product for not measuring blood pressure, because it will be the cause of the accident or dispute.
• Please do not use chemical reagents such as thinner, alcohol, gasoline to clean this product.
• Do not beat the product heavily or fall from a height.
• Please be sure to use the special arm belt of this product, otherwise it cannot be measured accurately.
• Do not use the mobile phone near the machine. There is a risk of making the machine to malfunction.
• Do not disassemble, repair or reconstruct the machine and the arm belt of the blood pressure meter, otherwise, it cannot be measured correctly
• Do not force a bending of the arm belt or the air tube.
• When removing the air pipe, please take out the air pipe at the front part of it.
• Don’t exert pressure on the product before the arm belt is twined around the arm.
• As the dry battery leakage can damage the product, so please pay attention to the following points.
• If you do not use the product for a long time (more than 3 months), please take out the battery.
• After use, replace the battery that is in power shortage with a new one immediately.
• Do not intermix old and new batteries.
• No modification of this equipment is allowed.
• Do not press the tube or limit the connection of tube.
• Kinking of the tube may cause continuous pressure impact the patient’s blood and cause injury.
• Excessive frequency measurement may cause the patient injury.
• If the cuff used on the injured arm, may cause farther harm.
• Do not use the cuff in the side of breast resection frequency, it may cause injury.
• Install the positive and negative battery correctly.

Product Introduction

Intended use

• The blood pressure monitor is used for measuring blood pressure and pulse rate.
• The monitor can be used in hospitals, families, schools and medical centers. It is suitable for adult, not for neonate or pregnancy.

Contraindications

• The product can not be used for patients with arrhythmia.
• This product can not be used for infants ,neonates or pregnancy. The product is only used for adult.
• The infant and people who can not express himself can not use this product.

The part of machine

Display Screen

Functional Description

1. Measurement: Buck measurement
2. The results showed that: high pressure / low pressure / pulse
3. Unit Conversion: blood pressure units KPa / mmHg conversion (the default boot unit is mmHg)
4. Memory Group: Two sets of memory, each 60 measurements results of memory
5. Low power testing: any working-state detecting low power, displays ” ” symbol prompts low power
6. Blood pressure classification indicator: blood pressure classification indicates blood pressure health, see Appendix Table 1
7. Error: See Appendix Table 2
8. Over pressure protection function: pressure over 295mmHg (10ms) is automatically and quickly exhaust
9. Auto power off function: No action for 1 minute then automatic shutdown
10. Measurement is completed alert tone.

Working principle

Oscillography method.
The cuff is pressurized to block the brachial blood flow and then slowly decompress, with a small pulse of sound and pressure in the arm. In wave method is to rely on the instrument recognition from the arm to the cuff of small pulse, and the difference, through multiple processing, form a scan reflect the envelope of pulse peak, which blood pressure values are obtained.

Disposal statement

• Directly disposing electronic products and battery will pollute and harm the environment.
• Disposal of this product and used batteries should be carried out in accordance with the national regulations for the disposal of electronic products.

Battery Charging

This product has a built-in lithium battery.
When the battery is depleted, it needs to be charged：

1. Power adapter requirements: AC IN: AC110~240V，50Hz，0.2A
   • OUT: DC5V/1000mA
2. The power adapter needs to be purchased by the user themselves.

Note

• Icon “ “: indicates the battery is about to run out. Please charge the lithium battery in a timely manner.
• If not used for a long time,Please fully charge every 2 months.
• Methods of disposal after use batteries should be handled according to local regulations on environmental protection.

Initial Setting

Please conduct initial setting before the first measurement if you want to use memory and average value function. Initial setting includes settings of user, Sound and blood pressure unit.

User Setting

In the shutdown state, short press SET key until the user symbol ” ” on screen starts flashing up , press the SET key to switch” “or” ” for choosing user, then press START/STOP key for confirming. mode at the same time, if not to choose the system defaults user “ “.

Sound setting

In the shutdown state, long press SET key , display “SP” ;the “ON” or “OFF” is in a flashing state now. Press MEMORY key to choose, when set to “ON”, there is a voice prompt when BP monitor is under measurement and viewing memory; when set to “OFF”, there is no voice prompt. After choosing it, press SET key for confirming. The system defaults “ON” if you didn’t choose anything.

Note

• If the instrument is optional without voice, no need to set the sound.

BP Unit Setting

The system defaults mmHg. In the shutdown state, long press START/STOP key for 5 second, it shows 0.0kPa, then press START/STOP key shut down to confirm kPa. If in kPa mode, in shutdown state, long press START/STOP key for 5 seconds, it shows 0mmHg, then press START/STOP key shut down to confirm mmHg.

Static Pressure Test Mode

• The blood pressure monitor has a static pressure test mode for relevant technical department to test.

Bluetooth function

• If the product supports Bluetooth connectivity,Please ensure that the Bluetooth of the receiving device is turned on.
• After adding this device,The “ ” icon will light up; the measured blood pressure and pulse values will be transmitted to the receiving device.

Usage of NIBP Cuff

1. Insert the tracheal plug into spigot of blood pressure monitor for cuff.
2. Adjust the cuff to tubular until it is suitable to put your arm inside.
3. Arm pass through the cuff. The cuff air pipe should be located the palm Front end.
4. The cuff should be wind on the upper arm.Colored markers should be located in the middle of the inboard arm and pointing down to the inside of the arm, the air pipe is also located in the inboard and be in a line with middle finger.
5. The bottom of the cuff should be located on the elbow in upper arm, the bottom of the cuff should be 2cm-3cm from the elbow.
6. Please close the cuff by buckle. The gap between the arm and cuff can accommodate your index finger.

Measure blood pressure

The Correct measurement method

The left arm, right arm are all-ok to measure, be bare arms or only wear thin clothes to measure. Please measure at a suitable room temperature

1. Put your elbows on the table;
2. The cuff height should be consistent with the heart;
3. The palm should be upward, relax the body.

Attention

• If you wear thick clothes, do not roll up your sleeves, but take off and measure it.
• In order to accurately measure, please pay attention to the correct winding cuff (Refer to “4 The method of using cuff”).
• Please do not press your arms on the air tube, or you may restrict the flow of air to the cuff.
• Please be in the same pose for blood pressure measurement, every day at the same time, with the same arm.
• The location of the cuff will cause changes of measurement results
• Do not touch the machine, cuff and air pipe during measuring.
• You should keep quiet when start measuring, the body should be in a state of relaxation
• Please be quiet for 4~5 minutes before measurement.
• Relax your body, don’t let muscle activity
• Do not talk or move when you are measuring.
• Please wait for 2-3 minute if you want to measure again.
• Do not use mobile phones and other mobile devices in the vicinity of the machine.

Operation steps of blood pressure measurement

The machine has two kinds of BP units, which are mmHg and KPa, please refer to 3.3 part for the specific method of setting.
Take the mmHg value as an example in the following explanation.

1. Press the “START/STOP” key, the machine will automatically return to zero, arm with automatic start filling with air, the pump started to inflate the cuff, the screen will display the pressure changes in the cuff. In the process of inflation, blood pressure meter also detects the pulse, so during the whole measurement process, please do not move the arm, keep the stationary state.
2. When the air in cuff reaches a stable pressure, pump stop inflating, the pressure cuff gradually decrease and will be displayed on the screen at the same time, the heart icon will flash .
3. After the measurement, the machine will simultaneously exhaust and displays your blood pressure value and the pulse number.
   • Note: the machine will automatically save the blood pressure and the pulse number.
4. Interrupt measurement：
   • If you need to interrupt the measurement for some reason (for example, you feel not good), at any time, press the “START/STOP” key, the machine will automatically reduce the arm with air pressure, interrupt measurement.
5. Important hints：
   • For the same user, the interval between the two measurements is at least 2-3 minutes. Between the two measurements of waiting is mainly to let the artery restored to the state before the measurement of blood pressure
   • In the measurement process, if the body is moving, it will result in inaccurate measurement, or it will measure the failure, and it will display error message. In this case, please repeat the measurement process, and keep quiet until the end of the measurement.
   • If Irregular Heartbeat (IHB) brought by common arrhythmias is detected in the procedure of blood pressure measurement, a signal of “ ”will be displayed. Under this condition, the blood pressure monitor can continue functioning, but the results may not be accurate, it is suggested that you consult with your physician for accurate assessment.
   • It takes 30 minutes from the lowest storage temperature to ready for use the blood pressure monitor.
   • It takes 30 minutes from the highest storage temperature to ready for use the blood pressure monitor.

Answers to the question during measurement

your body and arms during measurement
Whether the sleeves rolled up too tight| wrap the cuff properly(refer to the 4.Usage of NIBP Cuff)
Exercise or be in an excited state before measurement| Confirm measuring blood pressure in a quiet and relaxed state. It’s best to take a few deep breaths before taking measurements to relax yourself
This machine is equipped with a battery and does not work after pressing the “START/STOP” button| Low battery level| Please    charge    the    lithium battery in a timely manner.
Unable to inflate| Whether the cuff leak| Change a new cuff
Whether the plug connected| Please connect correctly
The machine is in good working condition, but there are differences in each measurement result.| Blood pressure is dynamic, so there must be some differences between each measurement value.
Other anomalies| If measurement is still not possible, please contact us

Components

Memory Function

Memory data viewing

This blood pressure stores 2×60 set memory value, each measurement in it will automatically be stored. When it stores 2×60 set memory value, the old value will be covered by the new one. It can show the latest 3 times average value.

Note

• In order to make a note of measurement correctly, before measurement, please make sure that the right user and time is selected.
• Under one user, it stores 60 set data, when you save the 61th set date, the earliest one date will be deleted.

Read memory record

• The first short press the MEM key it will show the latest 3 times average value.

Note: When the number of memory value are less than 3 set, like there are 2 set memory value, the memory button will show this 2 set average value, if there is 1 set memory value, the memory button will show this 1 set average value, that is this 1 set measure value.

Read the result

• After viewing the average value,Press the MEM key, you can read the latest 1 time measurement value, repeat press the MEM key to cyclic switch in the previous measurements.

Delete the memory value

• In the memory checking state, Long press the MEM key and START/STOP key 2 seconds at same time, display ‘- -’, all memory values will be deleted.

Warning

• This operation deletes all memory values, users need to operate carefully.

Care And Maintenance

• Be sure to keep the notes and other correct usage in the user manual. Failure to obey the regulations will result in no quality claims from company.

Care methods

• Clean the blood pressure monitor frequently
• Use a soft dry cloth towel to clean this blood pressure monitor, if it is very filthy you can wet the towel with water or neutral detergent, wring out it and wipe the monitor.
• Disinfection the cuff with moistened 75% alcohol cotton wool.

Note

• Please prevent water or other liquid seep into the blood pressure monitor.

Suggestion

• Do not clean the body and cuff with naphtha, thinner or gasoline etc. Do not wet the cuff or attempt to clean the cuff with water

Storaging method

Advice

• Do not place the unit in the following places:Easy splashing
• Direct sunlight, high temperatures, humidity, dust, full of corrosive gas places
• Some slant, vibrative, shock place.
• Some place storing chemicals or corrosive gas.

Advice

• Please Store it after taking out the battery if not to use the unit long time. (more than three months)

Manufacturer’s Declaration of the EUT

Guidance and manufacturer´s declaration – electromagnetic emission– for all EQUIPMENT AND SYSTEMS

specified below. The customer or the user of product should assure that it is used in such an environment.
3| Emissions test| Compliance| Electromagnetic environment – guidance.

4

| ****

RF emissions CISPR 11

| ****

Group 1

| The product uses RF energy only for its internal function.Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
5| RF emissions CISPR 11| Class B| ****

The product is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

6| Harmonic     emissions IEC 61000-3-2| Class A
7| Voltage      fluctuations

/flicker emissions IEC 61000-3-3

| YES

Guidance and Manufacturer´s Declaration – Electromagnetic Immunity

The product is intended for use in the electromagnetic environment specified below. The customer or the user of the product should assure that it is used in such an environment.

Immunity test| EN 60601 test level| Compliance level| Electromagnetic environment -guidance
Electrostatic discharge (ESD) IEC 61000-4-2| ± 6 kV contact

± 8 kV air

| | ****

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

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

± 1 kV for input/output lines

| | ****

Mains power quality should be that of a

typical commercial or hospital environment.

Surge

IEC 61000-4-5

| ****

± 1 kV differential mode

± 2 kV common mode

| | Mains power quality should be that of a

typical commercial or hospital environment.

Voltage dips,short interruptions and voltage variations on power supply input lines IEC 61000-4-11| ****

< 5 % UT

(>95 % dip in UT ) for 0.5 cycle

40 % UT

(60 % dip in UT ) for 5 cycles

70 % UT

(30 % dip in UT ) for 25 cycles

< 5 % UT

(>95 % dip in UT ) for 5 sec

| | ****

Mains power quality should be that of a typical commercial or Hospital environment.If the user of the product requires continued operation during power mains interruptions, it is recommended that the product be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

| ****

3A/m

| | Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE| | UT is the a.c mains voltage prior to application of the test level.

Guidance and Manufacturer´s Declaration – Electromagnetic Immunity–for EQUIPMENT and SYSTEM those are not LIFE-SUPPORTING

Guidance and Manufacturer´s Declaration – Electromagnetic Immunity

The product is intended for use in the electromagnetic environment specified below. The customer or the user of the product should assure that it is used in such an environment.

Immunity Test| EN 60601

Test Level

| Compliance Level| Electromagnetic Environment – Guide
Conducted RF| 3 Vrms| N/A| Portable and mobile RF communications equipment should be used no closer to any part of the product including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

**Recommended separation distance**

**** Where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is

the recommended separation distance in metres (m).b

**** Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should

be less than the compliance level in each frequency range.b

Interference    may    occur    in    the vicinity of equipment marked with the following symbol:

IEC 61000-4-6| 150 kHz to 80 MHz|
Radiated RF| 10 V/m| 10 V/m
IEC 61000-4-3| 80 MHz to 2.5 GHz|
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic waves are affected by absorption and reflection from structures, objects and people.

a ) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the product is used exceeds the applicable RF compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the product.

b ) Over the frequency range 150 kHz to 80 MHz, field strengths should be less  than 10V/m.

Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Recommended Separation Distances Between

Portable and Mobile RF Communications Equipment and The Product

The product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the product as recommended below, according to the maximum output power of the communications equipment

Rated maximum output of transmitter| Separation distance according to frequency of transmitter/m
50 kHz to 80 MHz| 80 MHz to 800 MHz| 800 MHz to 2.5 GHz
****| |
W| | |
0.01| | |
0.1| | |
1| | |
10| | |
100| | |
For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

FCC STATEMENT

Any Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

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.

FCC RF Radiation Exposure Statement:

1. This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
2. This equipment complies with RF radiation exposure limits set forth for an uncontrolled environment.
3. The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction.

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.

Appendix

Product Specifications

Range

| SYS| 60-249 mmHg
DIA| 30-170 mmHg
Maximum cuff pressure| 294 mmHg
PR| 40-190times/min
Accuracy| NIBP| ±3mm Hg(±0.4kPa)
PR| ±5%
Power| Built-in Lithium Battery:3.7V/800mA

Bluetooth function

| RN1L| RN1L Pro
N/A| YES

Electrical parameters

| Working Voltage| 3.7-4.2V
Low electrical parameters| 3.5V±0.1V shutdown;
working current| RN1L:≤600mA| RN1L Pro：≤650mA

Working Condition

| Temperature| +10ºC～40 ºC
Humidity| 15%RH～85%RH
Atmospheric| 70kPa～106Pa
Transporting and storaging condition| Temperature| -40ºC～55 ºC
Humidity| 10%RH～93%RH
Atmospheric| 70kPa～106Pa

Security Type

| Classification of electric shock type| Ⅱ
Classification of electric shock degree| BF
Protection against liquid| IP21
Running mode| Continuous operation
Safety classification of using with flammable anesthetic gas or flammable anesthetic gas mixed with oxygen or nitrous oxide:| ****

Non AP/APG

Size| 153×73×50mm
N.W.| ≈ 450g
Expected service life| 5 years
Software identifier| V2.1.3.1

Blood pressure classification instructions

Table 1 Blood pressure classification instructions

Extent| High pressure

（mmHg）

| Low pressure

（mmHg）

---|---|---
Serious| ≥180| ≥110
Moderate| 160～179| 100～109
little higher| 140～159| 90～99
Normal| 90～139| 60～89

LCD Error message and the cause of error correspondence table

Table 1 LCD Error message and the cause of error correspondence table
(Please contact local distributor or manufacturer)

Systolic blood pressure display area appear Err Diastolic blood pressure display area appear 1| Sensor anomaly
Systolic blood pressure display area appear Err Diastolic blood pressure display area appear 2| Pulse is not detected
Systolic blood pressure display area appear Err Diastolic blood pressure display area appear 5| air tube blocks before inflating
Systolic blood pressure display area appear Err Diastolic blood pressure display area appear 6| Strong interference during measuring
Systolic blood pressure display area appear Err Diastolic blood pressure display area appear 7| Air pressure more than 295mmH （39.3kPa）

Services

1. One year free warranty period will be provided after sales.
2. Our company cannot provide the free warranty service due to the malfunction caused by personal reason, details as follow:
3. The malfunction caused by disassemble and modify the product.
4. The product inner malfunction caused by dropping while picking up or operating.
5. The malfunction caused by improper used or lack of reasonable cared.
6. The malfunction caused by operating not following the operator’s manual.
7. The malfunction caused by natural disasters, Such as flooding, fire.
8. The malfunction caused by improper repairing by repairing shop, which is not our authorized.
9. Please show your valid warranty card and shopping vouchers when youneed free service.
10. Please bring the product to repaired shop which is our authorized when you need free repaired.
11. When performing warranty service, if needed, you can provide information on product components to circuit diagrams and repairable identified by our qualified technical personnel.
12. We will collect reasonable charge when we repair some malfunctions which out warranty service.

Contact information

• Ningbo Ranor Medical Science & Technology Co., Ltd
• No.127 Fenghui Road, Wangchun Industrial Park, Haishu District, Ningbo,Zhejiang, 315100, China
• TEL: +86-574-89258630
• FAX: +86-574-88219485

Version number: V1.0

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