Hopkins 527014 User manual

User Manual
Hopkins®Digital Wrist BP
Thank you for selecting the Hopkins®Digital Wrist BP #527014.
To use this BP monitor correctly and safely, please read this entire
manual thoroughly and keep it for your reference.
Item #527014
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INDEX
INTRODUCTION ................................................................................................. 1
• Safety information
• Features & Components
• LCD display
BEFORE YOU START ..................................................................................... 4
• Installing and replacing batteries
• Setting date and time
MEASUREMENT ................................................................................................. 7
• Positioning the cuff
• Taking a measurement
RECORDED MEASUREMENTS ........................................................................ 9
• Recalling records
• Deleting records
USER INFORMATION ...................................................................................... 11
• Tips for operation
• Maintenance
ABOUT BLOOD PRESSURE ........................................................................... 13
• What are systolic and diastolic pressure?
• What is normal blood pressure?
• Why does my blood pressure uctuate throughout the day?
• Why is the reading I get from a healthcare provider different from the ones I take at home?
• Which wrist should I use to take my blood pressure?
TROUBLESHOOTING ....................................................................................... 15
SPECIFICATIONS ............................................................................................. 16
EMC GUIDANCE ................................................................................................ 17
WARRANTY INFORMATION ......................................................................... 21
Thank you for selecting the Hopkins® Digital Wrist BP (Item #527014). This monitor features
blood pressure measurement, pulse rate measurement, and an auto-save function.
Readings taken by the #527014 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 this product. Read this manual thoroughly before using this product
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1
INTRODUCTION
• This device is for adult use only.
• To avoid measurement errors, carefully read this manual before using this device.
• 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 and pulse rate.
• Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure. Do not begin
or end medical treatment based solely on self-monitoring, consult 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. This unit is not suitable for
continuous monitoring during medical emergencies or operations.
• If the cuff pressure exceeds (300 mmHg), the unit will automatically de ate. Should the cuff not de ate when pres-
sures exceeds (300 mmHg), detach the cuff from the wrist and press the START/STOP button to stop in ation.
• This device is not AP/APG equipment and not suitable for use in the presence of a  ammable anesthetic mixture with
air, or with oxygen, or nitrous oxide.
• This unit is not suitable for continuous monitoring during medical emergencies or operations. This device cannot be
used simultaneously with HF surgical equipment.
• This device is not intended for patient transports outside a healthcare facility.
• To avoid measurement errors, please avoid strong electromagnetic  eld radiated interference signals or electrical fast
transient/burst signals.
• The 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 sensitization or irritation reaction. Never apply the cuff over damaged skin.
• Please dispose of any accessories, detachable parts, and the ME EQUIPMENT itself according to your 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 Hopkins Medical Products if any unexpected operation or events occur.
• We recommend that you have your device calibrated after every two years of use. Please contact Hopkins Medical
Products to have your device calibrated.
• Please use only a soft cloth to clean the entire unit. Don’t use any abrasive or volatile cleaners.
• Always check this device to make sure that it is in proper working condition before use.
The following symbols may be used in the user manual, product labeling, or on
other components. They are the requirement of standard and use.
♥ Safety Information
Type B applied part Direct current
Follow instructions/directions
for use - mandatory action
Speci es serial number
DISPOSAL: Do not dispose this product as un-
sorted municipal waste. Collection of such waste
separately for special treatment is necessary.
Manufacture Date
CAUTION
!
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2
INTRODUCTION
♥ Monitor Components
• Measures Systolic Blood Pressure
• Measures Diastolic Blood Pressure
• Measures Pulse Rate
• Retains historic records of up to 60 previous measurements
♥ Features
MEM/UP BUTTON
START/STOP
BUTTON
SET/DOWN
BUTTON
SYSTOLIC
DIASTOLIC
PULSE RATE
TIME
LCD DISPLAY
BP LEVEL
INDICATOR
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3
INTRODUCTION
♥ LCD Display
SYMBOL DESCRIPTION EXPLANATION
SYS Systolic BP High pressure result
DIA Diastolic BP Low pressure result
Pul/min Pulse Pulse per Minute (Beats per Minute)
+Lo Low Battery Batteries are low and need to be replaced
mmHg Millimeters Mercury Measurement unit of blood pressure
Heart Rate Heart rate is being measured
Irregular Heartbeat Irregular heartbeat (arrhythmia) detected
Memory
If “MEM” shows, the displayed measurement value
is from the memory of recorded measurements
(See page 9 for instructions)
Average The average of the blood pressure measurements
Inating The unit is inating with air to obtain the needed
level of pressure
Deating The unit is deating and the air is being exhausted
from the cuff
Time (hour:minute) The current time (set by user)
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4
Replace the batteries when any of the following happens
•The +Lo shows
•The display dims
•The display does not light up when powering on
BEFORE YOU START
♥ Installing and Replacing the Batteries
1. Slide off the battery cover on the back of the unit.
2. Install the batteries by matching the correct polarity, as shown below.
Always use the correct battery type (2 alkaline AAA size)
3. Replace the battery cover.
• If this device will be stored for an extended period of time, please remove the batteries
in order to avoid corrosion.
• Used batteries are harmful to the environment, so please dispose of appropriately.
Remove the old batteries from the device and follow your local recycling guidelines
• Battery corrosion is not covered under your three year limited warranty.
CAUTION
!
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5
BEFORE YOU START
It is important to set the clock before using your blood pressure monitor
so that a time stamp can be assigned to each record stored in the memory.
(The year can be set to anywhere between 2010 and 2050.)
♥ Setting the Year, Date, and Time
1. When the unit is off, press the “SET” button
once then press “SET” again and hold for 3
seconds to enter the mode settings.
2. The [YEAR] will begin to  ash. Press
“MEM” to advance to the current year.
3. Press “SET” when you have reached
the correct year to save your choice
and advance to the next step.
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6
BEFORE YOU START
6. Your selected settings will advance for review and the
monitor will then turn off automatically.
• You should always rest for at least 5 minutes before measuring your blood
pressure.
• Wait at least 3 minutes between measurements. This allows your blood
circulation to recover.
• For a meaningful comparison, try to take blood pressure measurements under
similar conditions. For example, take daily measurements at approximately the
same time, on the same wrist, or as directed by a physician.
5. Repeat steps 2 and
3 to set the [HOUR] and
[MINUTE].
♥ Tips for Accuracy
4. Repeat steps 2 and 3 to
set the [MONTH] and [DAY].
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7
MEASUREMENT
♥ Positioning the Wrist Cuff
1. Remove all accessories (watch, bracelets, etc.) from your left wrist. If your
physician has diagnosed you with poor circulation in your left arm, use your
right wrist instead.
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. Keep the monitor level with your heart.
5. Position the edge of the cuff about 1 inch from your wrist.
6. 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 not be accurate.
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8
MEASUREMENT
♥ Start the Measurement
The monitor will calibrate and
adjust to zero automatically,
then in ate and begin the
measurement. (The monitor
will calibrate automatically
every time it is turned on.)
1. After correctly positioning the cuff, press the “START/STOP” button to turn
on the monitor and it will complete the whole measurement automatically.
2. Press the “START/STOP” button to power off the monitor,
otherwise it will automatically turn off within 1 minute.
The monitor will display and save the results
automatically.
The BP Level Indicator Scale on the left side of
the screen will display a color corresponding with
the category of your reading. For more about
blood pressure levels, see page 13.
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9
IHB & RECALLING RECORDS
♥ Recalling Recorded Measurements
1. Press the
“MEM” button
to display the
average of the
records.
The order of the record, date,
and time will display alternately.
The most recent record is shown rst. Each new measurement is assigned to the
rst (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so
on), and the last record is dropped from the list.
An irregular heartbeat (Arrhythmia) 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 when
the measurement results are displayed.
The appearance of the IHB symbol 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.
♥ Irregular Heartbeat Detector (IHB)
The corresponding date
was the 5th of January
The corresponding time
was 8:08 AM
2. Press either
the “MEM”
button or the
“SET” button to
toggle between
the records.
CAUTION
!
CAUTION
!
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DELETING RECORDS
10
♥ Deleting a Record from the Memory
If you did not get the correct measurement, you can delete
your most recent result, or you can delete all the results in
the measurement history by following the steps below:
1. Press “MEM” button to enter
the memory screen, then press
and hold the “MEM” button for
3 seconds – the display will
alternately ash “DEL ONE”
and “DEL ALL”.
2. To delete the most recent record, wait until the display
shows “DEL ONE”, then press the “SET” button .
3. To delete all of the records at once, repeat step 1 and when
the display shows “DELETE ALL” press the “SET” button.
4. When there are no stored records, or all the records
have been deleted, the display will show dashes instead of
numbers for the records.
NOTE: To exit out of the delete records
screen, press the “START/STOP” button.
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11
USER INFORMATION
♥ Tips for Measurement
Measurements taken under some circumstances may cause the monitor
to provide inaccurate readings:
Always wait at least 1 hour
after eating or drinking
Never take a reading immediately after
drinking tea or coffee, or after smoking.
Always wait at least 20 minutes after
taking a bath or shower
Never take a reading while talking
or moving your ngers
Never take a reading in a
very cold environment
Never take a reading when you
need to use the restroom
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USER INFORMATION
Avoid direct sunlight.
Do not submerge in water or
any other liquid.
Avoid shaking or dropping the monitor. Store at room temperature in
a dry, clean environment.
Never use a wet cloth to remove dirt.
Always use a clean, dry cloth. Do not wash the monitor or the cuff.
♥ Care and Storage
In order to get the best performance out of your blood pressure monitor,
please follow the instructions below:
12
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13
ABOUT BLOOD PRESSURE
♥ What is the standard blood pressure
classication?
Only a physician can tell you your normal blood pressure range. Please contact a physician
if your measurements fall outside of the normal ranges listed here. Please note that only a
physician can tell you whether your blood pressure value has reached a dangerous point.
The chart on the right is the standard
blood pressure classication published
by American Heart Association (AHA).
SYS 135 mm Hg
DIA 85 mm Hg
AHA Home Guideline for
Upper Limit of Normal BP
♥ What are Systolic and Diastolic Pressure?
When the ventricles contract to pump blood out of the
heart, the blood pressure reaches its highest pressure
in the cycle. This is known as systolic pressure. The
lowest blood pressure in the cycle occurs when the
heart relaxes between heartbeats, and this is known as
diastolic pressure.
The systolic pressure is the top number in your blood
pressure reading, and the diastolic is the bottom number.
CAUTION
!
BLOOD PRESSURE CATEGORY SYSTOLIC mm Hg
(upper number)
DIASTOLIC mm Hg
(lower number)
NORMAL LESS THAN 120 and LESS THAN 80
ELEVATED 120 – 129 and LESS THAN 80
HIGH BLOOD PRESSURE
(HYPERTENSION) STAGE 1 130 – 139 or 80 – 89
HIGH BLOOD PRESSURE
(HYPERTENSION) STAGE 2 140 OR HIGHER or 90 OR HIGHER
HYPERTENSIVE CRISIS
(consult your doctor immediately) HIGHER THAN 180 and/or HIGHER THAN 120
This chart reflects blood pressure categories defined by American Heart Association
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14
♥ Why does my blood pressure
uctuate throughout the day?
1. Individual blood pressure readings can naturally
vary throughout the day, so for the best accuracy,
take your readings the same way each time. (See
Tips for Accuracy on page 6.)
2. Blood pressure readings can uctuate if you are
taking medications.
2. If you are taking multiple readings, wait at least 3
minutes between readings for best accuracy.
ABOUT BLOOD PRESSURE
When taking your blood
pressure at home you
should always make sure
the cuff is fastened and
placed properly, and that
the cuff is not too tight or
too loose.
Make sure you are not
overly anxious or stressed
as this will elevate your
readings. It is recommended
to take 2-3 deep breaths
before beginning to take
your blood pressure.
♥ Why is the reading I get from
a healthcare provider different
from the ones I take at home?
Your blood pressure can be different even during a
24 hour period because of factors like the weather,
emotional state, recent exercise or exertion, etc.
Your readings may be elevated in a healthcare set-
ting because of anxiety caused by the “white coat
effect” and you may get lower readings at home
where you are calmer.
♥ Which wrist should I use to
take my blood pressure?
Blood pressure readings can be taken on either the right
or left wrist, but it is recommended to take readings using
the left wrist. Consult your physician if you think you
need to use your right wrist instead. Whichever wrist you
use, it is important to take your blood pressure using the
same wrist every time you take a reading.
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15
TROUBLESHOOTING
This section includes a list of error messages and frequently asked questions for
problems you may encounter with your blood pressure monitor. If this product is not
operating as you think it should, please check here before arranging for service.
PROBLEM SYMPTOM REASON REMEDY
No Power
Display is
dim or will not
light up
The batteries may be dead. Replace with new batteries.
The batteries may not be
inserted correctly.
Check that the batteries
are inserted correctly.
Low
Batteries
+Lo Shows
on the display
The batteries are low. Replace with new batteries.
Error
Messages
“E 1” Shows on
the display
The monitor detected
that the cuff is not
secure.
Refasten the cuff and take
a new reading.
“E 2” Shows on
the display
The monitor detected
that the cuff is too tight
Refasten the cuff and take
a new reading.
“E 3” Shows on
the display
The monitor detected
that the pressure of the
cuff is in excess.
Relax for a moment and
then take a new reading.
“E 10” or
“E 11” Shows
on the display
The monitor detected
motion while measuring.
Movement can affect the
measurement. Relax for a
moment and then take a
new reading. Try to remain
still for the second reading.
“E 20” Shows
on the display
The measurement
process does not detect
the pulse signal.
Loosen any clothing around
your arm and try to take
another reading.
“E 21” Shows
on the display
The treatment of the
measurement failed.
Relax for a moment and try
to take another reading.
“EEXX” Shows
on the display
A calibration error
occurred.
Take a new reading. If the
problem persists, contact
customer service for further
assistance. Refer to page
17 for warranty and contact
information.
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16
SPECIFICATIONS
Power Supply Two AAA Alkaline Batteries (included)
Display Model Digital LCD V.A. 1.42” x 1.61”
Measurement Mode Oscillographic Testing Mode
Measurement Range Pressure: 0 - 300 mmHg
Pulse Value: 40 - 199 beats/minute
Accuracy Pressure: 41˚F - 104˚F within ± 3 mmHg
Pulse Value: ± 5%
Normal Working
Conditions
Temperature: Approx. 41˚F - 104˚F
Relative Humidity ≤ 85%
Atmospheric Pressure: 645 - 795 mmHg
Cuff Circumference Approx. 5.3” - 8.4” (13.5 cm - 21.5 cm)
Weight Approx. 4.16 oz (excluding batteries)
External Dimensions Approx. 3.2” x 2.5” x 0.9”
Parts Included Two AAA Alkaline Batteries, and User Manual
Mode of Operation Continuous Operation
Degree of Protection Type B Applied Part
IP Classication IPX-0
Software Version V01
Device Classication Internally Powered ME Equipment
Storage & Transportation
Conditions
Temperature: -4°F to 104°F (-20°C to 40°C)
Relative Humidity:10% RH to 93% RH
Atmospheric Pressure: 50 kPa to 106 kPa
WARNING: No modification of this equipment is allowed
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17
EMC GUIDANCE
Risk Management ISO 14971:2007
Labeling EN 980:2008
User Manual EN 1041:2008
General Requirements for Safety IEC 60601-1:2005
Non-invasive Sphygmomanometers
General Requirements
AASI/AAMI SP10:2002/A1:2003/A2:2006/ (R)2008
Electromagnetic Compatibility IEC 60601-1-2:2007
♥ Compiled Standards List
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specied below.
The customer or the user of the device should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1
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.
RF emissions
CISPR 11 Class B
Harmonic emissions
IEC 60100-3-2 Not applicable
Voltage uctuations/icker
emissions IEC 61000-3-3 Not applicable
♥ 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.
♥ EMC Guidance
Table 1 Guidance and MANUFACTURER’s Declaration — ELECTROMAGNETIC EMISSIONS
— for all ME EQUIPMENT and ME SYSTEMS
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18
EMC GUIDANCE
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specied below.
The customer or the user of the device should assure that it is used in such an environment
IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete
or ceramic tile. If oors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge IEC
61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to earth
Not applicable
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 s
Not applicable
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.
Power frequency
(50/60Hz)
magnetic eld
IEC 61000-4-8
3A/m 3A/m
Power frequency magnetic elds
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
NOTE UTis 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
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