Hopkins IMPACT 526018 User manual

User Manual
Hopkins®IMPACT Digital BP Monitor
Thank you for selecting the Hopkins®IMPACT Digital BP Monitor
#526018. To use this BP monitor correctly and safely, please read this
entire manual thoroughly and keep it for your reference.
Item #526018

INDEX
INTRODUCTION ................................................................................................. 1
• Safety information
• LCD display
• Monitor components
BEFORE YOU START ..................................................................................... 4
• Installing and replacing batteries
• Setting date and time
MEASUREMENT ................................................................................................. 7
• Positioning the cuff
• Taking a measurement
RECALLING RECORDED MEASUREMENTS .............................................. 9
• Recalling records
• Deleting records
INFORMATION FOR THE USER ..................................................................... 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 arm should I use to take my blood pressure?
TROUBLESHOOTING ...................................................................................... 15
SPECIFICATIONS ............................................................................................. 16
WARRANTY INFORMATION ......................................................................... 21
Thank you for selecting the Hopkins® IMPACT Digital BP Monitor (Item #526018). This monitor
fea-tures blood pressure measurement, pulse rate measurement, and an auto-save function.
Readings taken by the #526018 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

INTRODUCTION
1
• Measures Systolic Blood Pressure
• Measures Diastolic Blood Pressure
• Measures Pulse Rate
• Retains historic records of up to 60
previous measurements
• Large 5.5” x 1.5” bright LCD display
The following symbols may be used in the user manual, product labeling, or on
other components. They are the requirement of standard and use.
♥Features
♥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
unsorted municipal waste.
Collection of such waste
separately for special
treatment is necessary.
Manufacture Date

!
Caution: These notes
must be observed to
prevent any damage
to the device.
• 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 arm 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.
• Sensitive people, including pregnant women pre-eclamptic patients,
patients who have implanted medical electronic instruments and have
atrial brillation (AF), premature ventricular beats and peripheral arterial
disease (PAD), should avoid using the unit whenever possible.
• This device has been evaluated clinically with a manual cuff/
stethoscope auscultation as a 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
for manual, electronic, or automated sphygmomanometers.
• If the cuff pressure exceeds (300 mmHg), the unit will automatically
deate. Should the cuff not deate when pressures exceeds (300
mmHg), detach the cuff from the arm 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.
CAUTION

!

INTRODUCTION
2
♥ 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)
Low Battery Batteries are low and need to be replaced
mmHg Millimeters Mercury Measurement unit of blood pressure
Memory
If “M” shows, the displayed measurement value
is from the memory of recorded measurements
(See page 9 for instructions)
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)
Shock Warning Inaccurate readings may occur if unit is hit,
dropped, shaken, or otherwise shocked
Average The average of the blood pressure measurements
Recalling The stored records are being retrieved
Irregular Heartbeat Irregular heartbeat (arrhythmia) detected
BP Category
Indicator
Blood pressure level reading
(See page 13 for instructions)

AAA
AAA AAA AAA
CUFF TUBING
A
IR CONNECTOR
PLUG
AIR HOSE
LCD DISPLAY
MEM/DOWN BUTTON
START/OFF BUTTON
SET/UP BUTTON
CUFF
BP CATEGORY
INDICATTOR
INTRODUCTION
3
♥ Monitor Components
♥ Parts Included
#526018 Hopkins®IMPACT
Digital BP Monitor
Adult Digital Cuff
Cuff Circumference: 8.5” - 12.5”
(22cm - 32cm)
Four AAA Batteries
BATTERY COMPARTMENT
Pressure Measurement
System Components:
1. Cuff
2. Air Connector Plug
3. Micro Control Unit
3. Pump
4. Valve

1. Slide off the battery cover on the back of the unit.
2. Install the batteries by matching the correct polarity, as shown above.
Always use the correct battery type (4 alkaline AAA size)
3. Replace the battery cover.
BEFORE YOU START
4
♥ Installing the Batteries
• 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.
• Never dispose of batteries in a re. Batteries may explode when exposed to heat.
• Battery corrosion is not covered under your three year limited warranty.
CAUTION
!
Replace the batteries when any of the following occurs:
•The screen shows
•The display dims
•The display does not light up

START STOP
ME
MS
ET
START STOP
ME
MS
ET
START STOP
ME
MS
ET
BEFORE YOU START
5
♥ Setting the Date and Time
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 2000 and 2050.)
1. When the unit is off,
press and hold the “SET”
button for 3 seconds to
enter the mode settings.
2. Press the “MEM” button
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.

START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEMSET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEMSET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEM SET
START STOP
MEMSET
BEFORE YOU START
6
4. Repeat steps 2 and 3 to set the [MONTH] and [DAY]
6. Once you have set the clock, the
screen will read “done” and the monitor
will then turn off automatically.
5. Repeat steps 2 and 3 to set the [HOUR] and [MINUTE]

2–3cm
2–3cm
2–3cm
MEASUREMENT
7
2. Fasten the cuff on your left upper
arm and position it so that the tube
toward the inside of arm in line with
your pinky nger.
♥ Positioning the Cuff
1. Make sure the air tube is connected
securely to the unit.
3. The cuff should be snug but not too
tight. You should be able to insert one
nger between the cuff and your arm.
4. Sit comfortably with your left arm resting on
a at surface.
If the index arrows fall outside the area marked
“OK”, please select a different size cuff.
•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 arm, or as directed by a physician.
♥ Tips for Accuracy

START STOP
ME
MS
ET
START STOP
MEMSET
START STOP
ME
MS
ET
START STOP
MEMSET
START STOP
MEMSET
START STOP
MEMSET
MEASUREMENT
8
♥ Start the Measurement
1. Press the “START/STOP” button to turn
on the monitor. The whole measurement
will take place automatically.
The LCD Display will power up.
The unit will adjust to zero and
calibrate automatically. (The
unit will calibrate every time it
is turned on.)
The unit will inate and begin to
take the measurement.
Once the measurement has been
taken, the unit will deate, display
the reading and the category of the
reading, and store the reading in the
memory.
2. Press the “START/STOP” button to turn
the monitor off, otherwise the monitor will
power off automatically within 1 minute.

will display on the
right side of the screen
It means the total
of records is 8,
the current is the No 2.
The corresponding
time is 10:38.
The corresponding
date is 11th of October.
It means the total
of records is 8,
the current is the No 2.
The corresponding
time is 10:38.
The corresponding
date is 11th of October.
START STOP
MEMSET
START STOP
ME
MS
ET
START STOP
MEMSET
START STOP
ME
MS
ET
RECORDED MEASUREMENTS
9
♥ Recalling Recorded Measurements
1. While the monitor is off, press the
“MEM” button to display the average
of the records.
2. Press either the “MEM” button or
the “SET” button to toggle between
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.
CAUTION
!
M
160
M
60 60
UP DOWN

RECORDED MEASUREMENTS
10
♥ Deleting a Record from the Memory
You can delete all the measurement results in the memory by following
the steps below:
1. While the monitor is off, press
and hold the “MEM” button for
3 seconds – the display will
alternately ash “dEL ALL” and
“dEL ONE”.
If you don’t want to delete any of
the records, press the “START/
STOP” button to escape.
4. If there is no record,
the display will be blank.
el one
2. To delete the most recent re-
cord, wait until the display shows
“dEL ONE”, then press the “SET”
button to delete the latest record.
3. To delete all of the records at
once, repeat step 1 and when the
display shows “DEL ALL” press
the “SET” button.
The word “dONE” will appear at
the bottom of the screen once the
action has been completed.
START STOP
MEMSET
START STOP
ME
MS
ET
el all
el
START STOP
ME
MS
ET
START STOP
MEMSET

USER INFORMATION
11
♥ 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

USER INFORMATION
12
♥ Care and Storage
In order to get the best performance out of your blood pressure monitor,
please follow the instructions below:
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.

press
artery
vein
blood discharging
Systolic
relax
blood entering
Diastolic
press
artery
vein
blood discharging
Systolic
relax
blood entering
Diastolic
ABOUT BLOOD PRESSURE
13
♥ 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.
♥ What is a Normal
Blood Pressure?
The following charts illustrate the blood
pressure classication level established by
the World Health Organization (WHO) and
International Society of Hypertension (ISH)
in 1999.
Only a physician can tell you your normal blood pressure range and the point at which you are at risk.
Consult your physician to obtain these values.
If the measurements taken with these products fall outside the range, consult your physician.
CAUTION
!
BP Level
(mmHg) Optimal BP Normal BP Mild
Hypertension
Moderate
Hypertension
Severe
Hypertension
SYS <120 120~139 140~159 160~179 >180
DIA <80 80~89 90~99 100~109 >110

ABOUT BLOOD PRESSURE
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 7.)
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. 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 arm should I use to
take my blood pressure?
Blood pressure readings can be taken on either the right
or left arm, but it is recommended to take readings using
the left arm. Consult your physician if you think you need
to use your right arm instead. Whichever arm you use, it
is important to take your blood pressure using the same
arm every time you take a reading.

TROUBLESHOOTING
15
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
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.

SPECIFICATIONS
16
Power Supply Four AAA Alkaline Batteries (included)
Display Model Digital LCD V.A. 5.5” x 1.5”
Measurement Mode Oscillographic Testing Mode
Measurement Range Pressure: 0 - 300mmHg
Pulse Value: 40 - 199 beats/minute
Accuracy Pressure: Within ± 3mmHg at 41˚F - 104˚F
Pulse Value: ± 5%
Normal Working Conditions
Temperature: Approx. 41˚F - 104˚F
Relative Humidity ≤ 85%
Atmospheric Pressure: 645 - 795 mmHg
Cuff Circumference Approx. 8.5” - 16.5” (22cm - 32cm)
Weight Approx. 12.2 oz (excluding batteries)
External Dimensions Approx. 7” x 3.75” x 1.5”
Parts Included Four AAA Alkaline Batteries, an Adult Cuff,
and a User Manual
Mode of Operation Continuous Operation
Degree of Protection Type B Applied Part
Storage & Transportation
Conditions
Temperature: -4°F to 140°F (-20°C to 60°C)
Relative Humidity:10% RH to 93% RH
Atmospheric Pressure: 50 kPa to 106 kPa
WARNING: No modification of this equipment is allowed

SPECIFICATIONS
17
Risk management in the application of medical devices EN/ISO 14971:2007
Graphical symbols for labeling medical devices EN 980: 2008
Medical equipment manufacturers to provide information EN 1041: 2008
Medical equipment Part1-1: General Requirements for Safety Collateral Standard: Safety requirements for
medical electrical systems
IEC 60601-1: 2005;
IEC 60601-1-2: 2007
Non-Invasive Sphygmomanometers General Requirements AASI/AAMI SP10:2002/
A1:2003/A2:2006/ (R)2008
Medical electrical equipment Part 1-2: Basic safety and essential performance of the general requirements
Collateral Standard: Electromagnetic compatibility requirements and tests EN 60601-1-2:2001+A1: 2006
♥ Complied Standards List
Table 1
Guidance and manufacture’s declaration – electromagnetic emissions - for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
The 526018 is intended for use in the electromagnetic environment specied below. The customer of the user of the 526018
should assure that it is used in such and environment.
Emission Test Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11 Group 1
The 526018 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 emission
CISPR 11 Group B The 526018 is suitable for use in all
establishments other than domestic and
those directly connected to the public low-
voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2 Not applicable
Voltage uctuations/ icker emissions
IEC 1000-3-3 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

SPECIFICATIONS
18
Table 2
Guidance and manufacture’s declaration – electromagnetic immunity - for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The 526018 is intended for use in the electromagnetic environment specied below. The customer or the user of
526018 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
601000-4-2
±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
±2 kV for power supply
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge IEC 6000-4-5 ±1 kV line(s) to line(s) ±1 kV differential 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
<5% UT(>95% dip in UT)
for 0.5 cycle Mains power quality should be
that of a typical commercial
or hospital environment. If the
user of the 526018 requires
continued operation during
power mains interruptions, it is
recommended that the 526018
be powered from an uninterrupt-
ible power supply or a battery.
40% UT(>60% dip in UT)
for 5 cycles
40% UT(>60% dip in UT)
for 5 cycles
70% UT(>30% dip in UT)
for 25 cycle
70% UT(>30% dip in UT)
for 25 cycle
5% UT(>95% dip in UT)
for 5 seconds
5% UT(>95% dip in UT)
for 5 seconds
Power frequency
(50Hz)
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 environ-
ment.
NOTE UTis the a.c. mains voltage prior to application of the test level.