Easy at Home EBP-017 User Manual

User Manual
Wrist Blood Pressure Monitor EBP-017
Version:1.0
Please do read the user manual carefully and thoroughly so as to ensure the safe usage of this product.
Please keep this manual in order to reference in future.
Thank you very much for selecting Wrist Blood Pressure Monitor EBP-017.
Wrist Type
EASY AT HOME MEDICAL,LLC
Any questions,please call toll-free :
1-855-822-6999 M-F 9 a.m.-5 p.m. CST
E-MAIL:service@healthcare-manager.com
1
CATALOGUE INTRODUCTION
INTRODUCTION ............................................................... 1
Safety Information LCD Display Signal Monitor Components
BEFORE YOU START .......................................................... 5
Installing and Replacing the Batteries Setting Date, Time and Measurement Unit
MEASUREMENT ............................................................... 8
Tie the Cuff Start Measurement
DATA MANAGEMENT 10
Recall the Records Delete the Records
INFORMATION FOR USER..................................................... 13
Tips for Measurement Maintenance
ABOUT BLOOD PRESSURE.................................................... 15
What are systolic pressure and diastolic pressure? What is the standard blood pressure classification? Why does my blood pressure fluctuate throughout the day? Why do I get a different blood pressure at home compared to the hospital? Is the result the same if measuring on the right wrist?
TROUBLESHOOTING ......................................................... 17
SPECIFICATIONS .............................................................18
CONTACT INFORMATION...................................................... 19
Safety Information
Thank you for selecting wrist type blood pressure Monitor (EBP-017). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service.
Readings taken by the EBP-017 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-by­step instructions for using the product.
Read the manual thoroughly before using the product.
FEATURES:
Systolic Blood Pressure Diastolic Blood Pressure
Pulse Rate Memory: Up to 60 pieces of records
The signs below might be in the user manual, labeling or other components. They are the
requirement of standard and using.
Symbol for “THE OPERATION GUIDE MUST BE READ”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE B APPLIED PARTS”
Symbol for “DIRECT CURRENT”
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”
Table of Contents
..........................................................
COMPLIED STANDARDS LIST ......................................19
FCC STATEMENT 20
General Description
General Description
.............................................................
Symbol for “MANUFACTURE DATE”
EMC GUIDANCE 20.............................................................
32
INTRODUCTION INTRODUCTION
LCD Display Signal
Systolic blood pressure
High pressure result
Diastolic blood pressure
Low pressure result
BPM
Pulse/minute; heartbeats/minute
Memory
mmHg
Measurement unit the blood pressure (1mmHg=0.133kPa)
kPa
Measurement unit of the blood pressure (1kPa=7.5mmHg)
Year/Month/Day,Hour/Minute
Current time
Movement error symbol
Shocking will result in inaccurate
CUFF air is exhausting of deflatingDeflating
Low battery
Batteries are low and need to be replaced
Grade The grade of the blood pressure
SYMBOL DESCRIPTION EXPLANATION
Arrhythmia Irregular heartbeat
Heartbeat
Heartbeat detection during the measurement
The displayed measurement values is from the memory.
This device is intended for adult use only.
This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the wrist or for functions other than obtaining a blood pressure measurement.
Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment without asking a physician for treatment advice.
If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician.
If the cuff pressure exceeds 40 kPa (300 mmHg),the unit will automatically deflate. Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the wrist and press the START/STOP button to stop inflation.
To avoid measurement errors, carefully read this manual before using the product.
The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide.
The operator shall not touch output of batteries and the patient simultaneously.
The user must check that the equipment functions safely and see that it is in proper working condition before being used.
CAUTION
This device is contraindicated for any female subject who may be suspected of, or is pregnant.
Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE.
Otherwise, it may cause damage to the unit or danger to the user/patients.
Manufacturer will make available on request circuit diagrams, component parts list etc.
This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient’s wrist and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
Please use the device under the environment which was provided in the user manual. Otherwise,
the performance and lifetime of the device will be impacted and reduced.
During use, the patient will be in contact with the cuff.The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential alergic reaction or contact injury.
The device doesn’t need to be calibrated within the two years of reliable service. Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the
local guidelines.
When the device was 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.
The device has been evaluated clinically using manual cuff/stethoscope auscultation as the reference. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard, Manual, electronic, or automated sphygmomanometers.”
Do not use the monitor under the conditions of strong electromagnetic field (e.g. medical RF equipment) that radiates interference signal or electrical fast transient / burst signal.
CUFF (Type B applied part)
BATTERY COMPARTMENT
Monitor Components
List
1.Wrist Blood Pressure Monitor (EBP-017)
3.User manual2. 2×AAA batteries
Component List
1.PCBA
2.Air Pipe
3.Pump
4.Valve
5.Cuff
54
BEFORE YOU START
Installing and Replacing the Batteries
CAUTION
1.Open the battery
door.
2.Insert the batteries
according to the polarity indications
.
(Always select the
authorized / specified 2×AAA batteries.)
3.Close the battery
door.
displays on the LCD.
The LCD display dims.
When powering on the monitor, the LCD doesn’t light up.
Replace the batteries under following circumstances:
Remove batteries if the device is not likely to be used for some time.
Worn batteries are harmful to the environment. so please do not dispose with other daily trash.
Remove the old batteries from the device following your local recycling guidelines.
INTRODUCTION
Do not dispose of batteries in fire. Batteries may explode or leak.
LCD DISPLAY
SYSTOLIC
DIASTOLIC
MEM BUTTON
SET BUTTON
START/STOP BUTTON
PULSE RATE
GRADE
TIME
Memory
Norm
OptimOptim
Time Date
Setting Date, Time and Measurement Unit
Please proceed to time setting before your initial use so as to ensure each piece of record are labled with a time stamp. (Year Range: 2010-2050)
1.When the monitor is OFF, press
the SET button to enter into the clock mode, then press and hold “SET” button for about 3 seconds to enter year setting.
2.Press “MEM” button to change the numeral. Each press will increase the numeral by one in a cycling manner.
3.Press “SET” button to confirm the [YEAR]. Then the monitor diverts to [MONTH] and [DAY] setting.
76
BEFORE YOU START
4.Repeat steps 2 and 3 to set the [MONTH] and [DAY]. Then
it will enter into time format setting.
5.Select the 24 hours time format or the 12 hours time format. Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
6.Repeat steps 2 and 3 to set the measurement unit.
7.After confirming the meausrement unit, the LCD will display all the settings you have done one by one and the monitor will shut off.
BEFORE YOU START
Tie the Cuff
1
.Remove all accessories (watch , bracelet, e tc) from your left wrist. I f your physician has diagnosed you with poor circulation in your left wrist, use your right wrist.
2.
Roll or push up your sleeve to expose the skin.
3.
Apply the cuff to your left wrist with your palm facing up.
4
.
Position the edge of the cuff about 1-1.5cm (0.4 -0.6
) from wrist joints
.
5
.
Fasten the wrist cuff around your wrist, leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will be inaccurate.
Rest for 5 minutes before measuring. Wait at least 3 minutes between m easurements. This allows your blood circulation to recover. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurement at approximately the same time, on the same wrist, or as directed by a physician.
98
MEASUREMENT
Start Measurement
1.After correctly positioning the cuff, press START/STOP button to turn on the monitor, and it will complete the measurement process.
Adjust to zero.
Inflating and measuring.
Display and save the
measuring result.
2.Press START/STOP button to turn off the monitor. Otherwise, the monitor will shut off within 1 minute.
MEASUREMENT
LCD Display.
Norm
Optim
Time Date
Keep the BP monitor the same level of your heart
Recall the Records
CAUTION
The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped from the list.
The exact time and date of the measurement will display alternatively.
2. Press “MEM” button again, it will display the latest measurement record. Press “MEM” button to rotate the history records. Press SET button to look back the record. You can check 60 groups of record totally. When it displays the record, it will shutdown in 1minute if has no operation.
1.When the blood pressure monitor is off, press “MEM” button to access the memory, it will display the latest record first when the records are less than three groups. When there are three or more than three groups ,it will display the average value of the latest three records first.
1110
DATA MANAGEMENT
3.When there has no record, the LCD displays “---”.
DATA MANAGEMENT
UP
DOWN
The corresponding time is 10:38.
The corresponding date is January 1st.
Tips for Measurement
Delete the Records
When you did not obtain the accurate measurement, you can clear all the
measuring results by following steps below.
1.Press and hold both the “MEM” button for 3 seconds when the monitor is in the memory recall mode, the flash display “dEL ALL” will show.
2.When the LCD display blinking “dEL ALL”, press “SET” button to confirm clearing.
The LCD will display “dEL dONE”,
indicating that memory clearing is complete.
3.If you wish to give up clearing, press the START/STOP button to turn off the monitor.
Measurements may be inaccurate if taken in the following
circumstances.
Within 1 hour
after dinner or drinking
Within 20 minutes after taking a bath
In a very cold environment
Immediate measurement after tea, coffee, smoking
When talking or moving your fingers
When you want to discharge urine
1312
INFORMATION FOR USER
DATA MANAGEMENT
Maintenance
What are systolic pressure and diastolic pressure?
press
artery
vein
blood discharging
Systolic
relax
blood entering
Diastolic
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?
INFORMATION FOR USER
To obtain the best performance, please follow the instructions below.
Put in a dry place and avoid the sunshine
Avoid intense shaking
and collisions
Use wet cloths to remove dirt
Avoid touching water,
clean it with a dry cloth in case.
Avoid dusty and unstable
temperature environment
Avoid washing the cuff
Irregular Heartbeat Detector
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.
The chart on the right is the standard blood pressure classifi­cation published by American Heart Association (AHA).
AHA Home Guideline for Upper Limit of Normal BP
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.
CAUTION
SYS 135 mm Hg
DIA 85 mm Hg
Blood Pressure Category
Normal
Prehypertension
High Blood Pressure
(Hypertension) Stage 1
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Emergency care needed)
Systolic mmHg (upper#)
Diastolic mmHg (lower#)
less than 120
120-139
140-159
160 or higher
Higher than 180
and
or
or
or
or
less than 80
80-89
90-99
100 or higher
Higher than 110
This chart reflects blood pressure categories defined by American Heart Association.
14
15
INFORMATION FOR USER
ABOUT BLOOD PRESSURE
• If you have any problems with this device, such as setting up, maintaining or using,
please contact the SERVICE PERSONNEL of . Don’t open or repair the device by yourself.
• Please report to if any unexpected operation or events occur.
CAUTION
Norm
Optim
Norm
Optim
Time
Date
Norm
Optim
Time Date
Norm
Optim
Norm
Optim
Norm
O ptim
An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 15,the irregular heartbeat symbol appears on the symbol when the measurement results are displayed.
Time
Date
Time
Date
Time
Date
Time
Date
1716
TROUBLESHOOTINGABOUT BLOOD PRESSURE
1. I ndividual blood press ure varies multiple times everyday, it is also affect­ed by the way you tie your cuff and mea­surement posi tion, 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 does my blood pressure fluctuate throughout the day?
Is the result the same i f measu ring o n t he right wrist?
It is ok for both wrists, but there will be some different results for different people. We suggest yo u measure the same wrist every time.
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.
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 wrist.
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.
This section includes a lis t of error messages and frequently asked questions for problems you may encounter with your wrist blood pressure monitor. If the pr oducts not operating as y ou think i t should, check here before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low batteries
Error massage
Display is dim or
will not light up.
Batteries are exhausted.
Replace with new batteries
Insert the batteries
correctly
Replace with new batteries
Batteries are inserted incorrectly.
Show on the display
Batteries are low.
E 1 shows
The cuff is not secure.
Refasten the cuff and then measure again.
E 2 shows The cuff is very tight
Refasten the cuff and then measure again.
E 3 shows
The pressure of the cuff is excess.
Relax for a moment and then measure again.
E 10 or E 11 shows
The monitor detected motion while measuring.
Movement can affect the measurement.Relax for a moment and then measure again.
E 20 shows
E 21 shows
Relax for a moment and then measure again.
EExx,shows on the display.
A calibration error occurred.
Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance.Refer to the warranty for contact information and return instructions.
The measurement process does not detect the pulse signal.
Loosen the clothing on the wrist and then measure again.
Measure incorrectly.
Power Supply
Battery powered mode:
2×AAA batteries (3V)
Display Mode
Measurement Mode
Oscillographic testing mode
Measurement Range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the wrist
About 13.5cm-21.5cm( )
Weight
External dimensions
Attachment
2×AAA batteries,one storage,user manual
Mode of operation
Continuous operation
Degree of protection
Software version
Device classification
V01
Internally Powered ME Equipment
WARNING: No modification of this equipment is allowed.
Contact Information
Complied Standards List
For more information about our products, please visit , or call Customer 1-866-822-6999 M-F 9 a.m.-5 p.m.CST, usual problems and customer download, will serve you anytime.
Pressure: 0kPa-40kPa0mmHg-300mmHg
pulse value:(40-199)beat/minute
Approx.112g(3.95oz)(Excluding batteries)
Type B applied part
IP Classification
IP×0
1918
CONTACT INFORMATIONSPECIFICATIONS
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Non-invasive Sphygmomanometers General Requirements
ISO 14971:2007
EN 980:2008
EN 1041:2008
IEC 60601-1:2005
IEC 60601-1-2:2007
AASI/AAMI SP10:2002/A1:2003/A2:2006/(R)2008
Digital LCD V.A 31.5mm×44mm(1.25’’×1.73’’)
Pressure:
5-40(41-104)within±0.4kPa(3mmHg)
pulse value:±5%
Temperature:5 to 40(41 to 104)
Relative humidity: ≤85%RH
Atmospheric pressure: 86kPa to 106kPa
Temperature:-20-60 Relative Humidity: 10%RH-93%RH Atmospheric Pressure: 50kPa-106 kPa
(-4 - 140)
Approx. 68mm×75mm×31mm(2.68”×2.95”×1.22”) (Excluding the cuff)
5
-
/
1
3
8
/
1
2
20
Table 1 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC EMISSIONS- for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emissions
RF emissions CISPR 11
Group 1
Class B
Not applicable
Not applicable
Compliance
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker emissions IEC 61000-3-3
RF emissions CISPR 11
Emissions test Electromagnetic environment - guidance
The device 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.
Guidance and manufacturer’s declaration – electromagnetic immunity
IMMUNITY test
±6 kV contact ±8 kV air
±6 kV contact ±8 kV air
±2 kV for power supply lines
Not applicable
±1 kV line(s) to line(s) ±2 kV line(s) to earth
<5% U
T
(>95% dip in UT) for 0.5 cycle
40% U
T
(60% dip in UT) for 5 cycles
70% U
T
(30% dip in UT) for 25 cycles
<5% U
T
(>95% dip in UT) for 5 s
3A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
Table 2 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS
IEC 60601 test level Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
3A/m
Power frequency (50/60Hz) magnetic field
IEC 61000-4-8
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment
EMC Guidance
21
±1 kV for input/output lines
Not applicable
Not applicable
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.
EMC GUIDANCE
FCC Statement
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.
22
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Table 6 Recommended separation distances between portable and mobile
RF communications equipment and the ME EQUIPMENT or ME SYSTEM –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances
between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmittters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter (m)
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 80MHz and 800MHz, 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.
0.01
0.1
1
10
100
Not applicable 0.117
0.369
1.167
3.690
11.67
0.233
0.738
2.333
7.378
23.33
23
PV=d ]
5,3
[
1
P=d 1.167
2.333
P=d
Not applicable
Not applicable
Not applicable
Not applicable
Table 4 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
IMMUNITY test
Not applicable
3 V/m
Compliance level
IEC 60601 TEST LEVEL
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to
2.5 GHz
3 Vrms
150 kHz to 80 MHz
Electromagnetic environment ­guidance
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
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).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
a
b
Interference may occur in the vicinity of equipment marked with the following symbol:
PV=d ]
5,3
[
1
P=d
80 MH z to 8 00 MHz
P=d 2.333
800 MH z to 2,5 GH z
1.167
NOTE 1 At 80 MHz and 800 MHz, 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.
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 device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [ ]V/m.
b
V
1
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