703US-0001 (黑) 703US-0002(白) 血压机TMB-1585

703US-0001 (黑) 703US-0002(白) 血压机TMB-1585
User Manual
Arm Blood Pressure Meter
Model : TMB-1585
Arm Type
Distributed by:
1byone Products Inc.
2313 E PHILADELPHIA ST STE M, CA, US, , 917618048
www.1byone.com
Thank you very much for selecting 1byone Arm Blood Pressure Meter.
Please do read the user manual carefully and thoroughtly so as to ensure the
safe usage of this product, and keep the manual well for further reference in
case you have problems.
CATALOGUE
CATALOGUE
Table of Contents
INTRODUCTION...................................................................................................................2
General Description
Indications for Use
Safety Information
LCD Display Signal
Monitor Components
List
BEFORE YOU START...........................................................................................................7
The Choice of Power Supply
Installing and Replacing the Batteries
Measurement Principle
Setting Date, Time and Measurement Unit
Select the User
MEASUREMENT.................................................................................................................12
Tie the Cuff
Start the Measurement
DATA MANAGEMENT.........................................................................................................14
Recall the Records
Delete the Records
INFORMATION FOR USER................................................................................................17
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE..............................................................................................19
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular Heartbeat Detector
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 arm?
TROUBLESHOOTING........................................................................................................21
SPECIFICATIONS..............................................................................................................22
AUTHORIZED COMPONENT ...........................................................................................23
COMPLIED STANDARDS LIST..........................................................................................24
FCC STATEMENT...............................................................................................................25
EMC GUIDANCE................................................................................................................25
1
INTRODUCTION
General Description
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:
100mm×68 mm Digital LCD display
Maximum 60 records per each user
3rd technonoly: Measuring during inflation
(The updated technology in the world)
Indications for Use
The 1by one Arm Blood Pressure Meter is digital monitors intended for use in
measuring blood pressure and heartbeat rate with arm circumference ranging
from about 22 cm to 42 cm ( about 8¾˝-16½˝ ).
It is intended for adult indoor use only.
2
INTRODUCTION
Safety Information
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
SN
Symbol for “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”
Symbol for “MANUFACTURE
DATE”
Symbol for “TYPE BF APPLIED
PARTS”
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”
Caution: These notes must be
observed to prevent any damage
to the device.
CAUTION
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 suitable for use on pregnant women, patients with implanted,
electrocical devices, patients with pre-elcampsia, 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
Do not take any therapeutic measures on the basis of a self measurement. Never alter
the dose of a medicine prescribed by a doctor. Consult your doctor if you have any
question about your blood pressure.
Please keep the unit out of reach of infants, children or pets, since inhalation or
swallowing of small parts is dangerous or even fatal.
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.”
3
INTRODUCTION
CAUTION
This device is intended only for adult use in homes.
This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is
not intended for use on extremities other than arm or for functions other than obtaining a blood
pressure measurement.
If you experience discomfort during a measurement, such as pain in the arm or other complaints,
press the START/STOP button to release the air immediately from the cuff. Loosen the cuff and
remove it from your arm.
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.
Too frequent and consecutive measurements could cause disturbances in blood circulation and
injuries.
Do not wrap the cuff on the same arm which other monitoring ME EQUIPMENT is applied
simultaneously, because this could cause temporary loss of function of those simultaneously-used
monitoring ME EQUIPMENT.
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.
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.
This unit is not suitable for continuous monitoring during medical emergencies or operations.
This device cannot be used with HF surgical equipment at the same time.
This device is not intended for patient transports outside a healthcare facility.
To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated
interference signal or electrical fast transient/burst signal.
The operator shall not touch output of batteries/adapter and the patient simultaneously.
Manufacturer will make available on request circuit diagrams, component parts list etc.
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 sensization or irritation
reaction.Never apply the cuff over hurt skin.
Do not use the unit in case of existing polyester resp. synthetic allergies.
Be careful to strangulation due to cables and hoses, particularly due to excessive length.
Do not connect the air hose to other medical equipment, as this could cause air to be pumped into
intravascular systems or high pressure, what could lead to dangerous injuries.
Before use, make sure the device functions safely and is in proper working condition.
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.
Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE.
Otherwise, it may cause damage to the unit or danger to the user/patients.
Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the
local guidelines.
Please do not attempt to repair the unit yourself in the event of malfunctions. Only have repairs
carried out by authorized service centers.
Please report to Manufacturer if any unexpected operation or events occur.
The device doesn’t need to be calibrated in two years of reliable service.
Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.
4
INTRODUCTION
LCD display signal
SYMBOL
DESCRIPTION
Systolic blood pressure
EXPLANATION
High pressure result
Diastolic blood pressure
Low pressure result
Pulse per minute
Beats per minute, BPM
Deflating
CUFF air is exhausting of deflating
Memory
The displayed measurement values
is from the memory.
kPa
mmHg
Measurement Unit of the blood pressure
(1kPa=7.5mmHg)
Measurement Unit of the blood pressure
(1mmHg=0.133kPa)
Low battery
Batteries are low and need to be replaced
Irregular heartbeat
Irregular heartbeat Detection
Grade
The grade of the blood pressure
Current Time
Heartbeat
User A
Year/Month/Day, Hour/Minute
Heartbeat detection during the
measurement
Start measurement and save the
measuring results for User A
User B
Start measurement and save the
measuring results for User B
Inflation
The air is inflating into the cuff.
5
BEFORE YOU START
INTRODUCTION
The Choice of Power Supply
Monitor Components
1.Battery powered mode:
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
CUFF
AIR HOSE
AIR CONNECTOR PLUG
6VDC 4×AAA batteries(Not Included)
2.AC adaptor powered mode:
6V 1A
(Please only use the recommended AC
adaptor model).(Not Included)
Please unplug the adaptor to depart from
the using utility power.
AC adaptor
CAUTION
In order to get the best effect and protect your Arm Blood Pressure Meter,
please use the right battery and special power adaptor which complies
with U.S. safety standard.
LCD DISPLAY
DC POWER SOCKET
Installing and Replacing the Batteries
SET BUTTON
• .Open the battery cover.
• .Install the batteries by matching
the correct polarity, as shown.
• .Replace the cover.
START/STOP BUTTON
MEM BUTTON
BATTERY COMPARTMENT
List
1.Arm Blood Pressure Meter
The
2.Cuff (Type BF applied part)
(about 22cm~42cm)
(Please use 1byone
authorized cuff. The size
of the actual cuff please
refer to the label on the
attached cuff.)
3. Storage bag
6
Replace the batteries whenever the below happen
4.User manual
shows
The display dims
The display does not light up
CAUTION
Remove batteries if the device is not likely to be used for some time.
The old batteries are harmful to the environment, do not dispose with other daily trash.
Remove the old batteries from the device and follow your local recycling guidelines.
Do not dispose of batteries in fire. Batteries may explode or leak.
7
BEFORE YOU START
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 air 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.
The device also compares the longest and the shortest time intervals of detected pulse
waves to mean time interval then calculates standard deviation. The device will display a
warning signal with the reading to indicate the detection of irregular heartbeat when the
difference of the time intervals is over 25%.
Setting Date, Time and Measurement Unit
It is important to set the clock before using your Arm Blood Pressure
Meter, so that a time stamp can be assigned to each record that
is stored in the memory. (The setting range of the year :2014—2054
time format:12H/24H)
BEFORE YOU START
3.When you get the right
year, press “S” button
to set down and turn to
next step. You can set
the [DATE FORMAT]
between D/M and M/D
by pressing 'M' button
4.Repeat steps 2 and 3 to set the [MONTH] and [DAY].
1.When the Arm Blood Pressure
Meter is off, hold pressing “S”
button about 3 seconds to enter
the mode for year setting.
5 .Repeat steps 2 and 3 to set the [TIME FORMAT] between 12H and 24H.
2.Press “M” button to
change the [YEAR]. Each
press will increase the
numeral by one in a
cycling manner.
8
9
BEFORE YOU START
6 .Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
BEFORE YOU START
Select the User
1.When the Arm Blood Pressure Meter is off , Press and hold
'M' button for 2 seconds to enter user setting mode. The user ID
will blink.
7.Repeat steps 2 and 3 to set the [UNIT].
2.Then press “M” button again, select the user ID between
user A and user B.
8.After the unit is set,the LCD will display “done” first, then display
all the settings you have done and then turn off.
3. After selecting the suitable user ID, press “S” button to
confirm. Then the LCD will turn off.
10
11
MEASUREMENT
MEASUREMENT
Tie the cuff
1.Tie the cuff on your upper arm,
then position the tube off-center
toward the inner side of arm in
line with the little finger.
Or position the artery mark Φ over
the main artery (on the inside of
your arm).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.
2.The cuff should be snug but not
too tight. You should be able to
insert one finger between the
cuff and your arm.
3.Sit comfortably with your tested
arm resting on a flat surface.
4.Patients with Hypertension:
The middle of the cuff should be
at the level of the right atrium of the heart;
Before starting measurement, please sit
comfortably with legs uncrossed,
feet flat on the floor, back and arm supported.
Rest for 5 minutes before
measuring.
Wait at least 3 minutes between
measurements. This allows your
blood circulation to recover.
For a meaningful comparison,
try to measure under similar
conditions. For example, take daily
measurements at approximately
the same time, position of upper
arm, or as directed by a physician.
12
Start the Measurement
1.When the Arm Blood Pressure Meter is off, press the “START/STOP”
button to turn on it, and it will finish the whole measurement.
(Take user A for example.)
LCD display
Adjust to zero.
2~3cm
Inflating and measuring.
Display and save the
measurement results.
2.Press the “START/STOP” button
to power off, otherwise it will turn
off within 1 minute.
Tips: Maximum 60 records are both for User A and User B.
13
DATA MANAGEMENT
DATA MANAGEMENT
Recall the Records
3. If you want to check another user’s records, press “START/STOP” button
to turn off the Arm Blood Pressure Meter when it is in the memory inquiry
mode. Press and hold 'M' button for 2 seconds to enter into the selecting user
ID mode, press “M” again to select the user ID between user A and user B,
press “S” button to confirm the user ID , then press “M” button to check the
selected user’s measurement records.
1. When the Arm Blood Pressure
Meter is off, please press “M” button
to show the average value of
the latest three records.
(Note: If the records are less than
3 groups, the LCD will display the
recent record instead. Take user A
for example.)
2. Press “M” button
or “S” button to get
the record you want.
The order, date and time
of the record will be shown
alternately.
CAUTION
The current No. is No. 1. The corresponding
date is May 25 th .
14
The corresponding
time is P.M. 9:37.
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.
15
DATA MANAGEMENT
INFORMATION FOR USER
Tips for Measurement
Delete the Records
If you did not get the correct measurement, you can delete all
results by following steps below. (Take User A for example.)
1.Hold pressing “M” button
for 3 seconds when the
Arm Blood Pressure Meter
is in the memory recall mode ,
the flash display “ User ID+
dEL ALL” will show.
Note: To exit out of delete mode
without deleting any records,
press START/STOP button
before pressing "S" button to
confirm any delete commands.
Measurements may be inaccurate if taken in the following
circumstances.
2.Press “S” button to
confirm deleting and
the Arm Blood Pressure
Meter will display “dEL
dOnE” and then turn off.
3. If there is no record.
the following display will
show.
Within 1 hour
after dinner or drinking
Immediate measurement
after tea, coffee, smoking
Within 20 minutes
after taking a bath
When talking or moving your fingers
In a very cold environment
16
When you want to discharge urine
17
INFORMATION FOR USER
ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic pressure?
Maintenance
In order to get the best performance, please follow the
instructions below.
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.
Systolic
Diastolic
press
relax
blood discharging
artery
blood entering
vein
What is the standard blood pressure classification?
Put in a dry place and avoid the sunshine
Avoid touching water,
clean it with a dry cloth in case.
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
SYS
DIA
Avoid intense shaking
and collisions
Avoid dusty and unstable
temperature environment
135 mm Hg
85 mm Hg
This chart reflects blood pressure categories defined by American Heart Association.
Blood Pressure Category
Systolic
mmHg (upper#)
Diastolic
mmHg (lower#)
less than 120
and
less than 80
Prehypertension
120-139
or
80-89
High Blood Pressure
(Hypertension) Stage 1
140-159
or
90-99
160 or higher
or
100 or higher
Higher than 180
or
Normal
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Emergency care needed)
Higher than 110
CAUTION
Only a physician can tell your normal BP range. Please contact a physician if your
measuring result falls out of the range. Please note that only a physician can tell
whether your blood pressure value has reached a dangerous point.
Irregular Heartbeat Detector
Using wet cloths to remove dirt
Do not attempt to clean the reusable cuff
with water and never immerse the cuff in
water.
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.
CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular
heart-beat was detected during measurement. Usually this is NOT a cause for concern.
However, if the symbol appears often, we recommend you seek medical advice. Please note
that the device does not replace a cardiac examination, but serves to detect pulse irregularities
at an early stage.
18
19
ABOUT BLOOD PRESSURE
TROUBLESHOOTING
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.
20
This section includes a list of error messages and frequently
asked questions for problems you may encounter with your Arm
Blood Pressure Meter . If the products not operating as you think it
should, check here before arranging for servicing.
PROBLEM SYMPTOM
No power
Display will not
light up.
Low
batteries
Display is dim or
show
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.
Error
message
CHECK THIS
REMEDY
Batteries are exhausted. Replace with new batteries
Batteries are inserted
incorrectly.
Insert the batteries
correctly
AC adaptor is inserted
incorrectly.
Insert the AC adaptor
tightly
Batteries are low.
Replace with new batteries
E 1 shows
The cuff is not secure.
Refasten the cuff and then
measure again.
E 2 shows
The cuff is very tight
Readjust the cuff ,not too
loose or too tight and then
measure again.
E 3 shows
The pressure of the
cuff is excess.
Relax for a moment
and then measure again.
E10 or E11
shows
The Arm Blood Pressure Relax for a
Meter detected motion, moment and then
measure again.
talking or the pluse is too
poor while measuring.
E20 shows
The measurement
Loosen the clothing on the
process does not detect arm and then measure
the pulse signal.
again
E21 shows
The treatment of the
measurement failed.
EExx,shows on
the display.
A calibration error
occurred.
Relax for a moment and
then measure again.
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.
21
SPECIFICATIONS
AUTHORIZED COMPONENT
Battery powered mode:
Power supply
Display mode
Measurement mode
Measurement range
Accuracy
6VDC 4×AAA batteries (Not Included)
AC adaptor powered mode:
6V
1A
(Please only use the recommended AC adaptor
model).(Not Included)
Digital LCD V.A.100mm×68mm
Oscillographic testing mode
Rated cuff pressure:
0mmHg~300mmHg(0kPa ~ 40kPa)
Measurement pressure:
SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa)
DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)
Pulse value: (40-199)beat/minute
Pressure:
5℃-40℃within±3mmHg(0.4kPa)
pulse value:±5%
Normal working condition
Temperature:5℃ to 40℃
Relative humidity: ≤85%RH
Atmospheric pressure: 86kPa to 106kPa
Storage & transportation
condition
Temperature:-20℃-60℃
Relative Humidity: 10%RH-93%RH
Atmospheric Pressure: 50kPa-106 kPa
Measurement perimeter
of the upper arm
Net Weight
External dimensions
Attachment
Mode of operation
Degree of protection
Authorized Component
1.please use the 1byone authorized adapter. (Not Included)
Adapter
SKU 703US-0003 (MODEL: KH0601000UW)
Input:100~240V~
50/60Hz, 0.3A Max
Output:6V
1000mA
About 22cm~42cm
Approx.282g(Excluding the dry cells and cuff)
Approx.154mm×106mm×57.1mm
1×storage bag,user manual
Continuous operation
Type BF applied part
Protection against
ingress of water
IP21
Software Version
V01
WARNING: No modification of this equipment is allowed.
22
23
COMPLIED STANDARDS LIST
EMC GUIDANCE
Complied Standards List
Risk management
Labeling
ISO/EN 15223-1:2012 Medical devices. Symbols to
be used with medical device labels, labelling and
information to be supplied. General requirements
User manual
EN 1041: 2008 Medical equipment manufacturers to
provide information
General Requirements
for Safety
IEC/EN 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic safety and
essential performance - Collateral
standard:Electromagnetic compatibility - Requirements
and tests
Performance
requirements and
Clinical investigation
IEC 80601-2-30:2009 Medical electrical equipmentPart 2-30: Particular requirements for the basic safety
and essential performance of automated non-invasive
sphygmomanometers
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic,
or automated sphygmomanometers
Usability
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.
IEC 60601-1: 2005+A1:2012 Medical electrical
equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-11 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
Software life-cycle
processes
24
ISO/EN 14971:2012 Medical devices — Application of
risk management to medical devices
IEC/EN 62304:2006+AC: 2008 Medical device
software - Software life cycle processes
IEC 62366 Medical devices - Application of usability
engineering to medical devices (IEC 62366:2007)
IEC 60601-1-6 Medical electrical equipment - Part 1
-6 : General requirements for basic safety and
essential performance - collateral standard : Usability
EMC Guidance
1) This equipment needs to be installed and put into service in accordance
with the information provided in the user manual;
2) 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 d=3,3m away from the equipment.
(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT,
a typical cell phone with a maximum output power of 2 W yields d=3, 3m at
an IMMUNITY LEVEL of 3V/m)
25
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