Graham Field LUMISCOPE 1133 User manual

AUTOMATIC DIGITAL
BLOOD PRESSURE MONITOR
Model 1133
Instruction manual
Para instrucciones en Español, vease la pagina 25
1133-INS-LAB-RevD20

PARTS AND COMPONENTS
1. Main Body
2. Display
3. Air Connector
4. Tube Plug
5. Air Hose
6. Cuff
7. D-ring
8. Button ‘M1’
9. Button ‘M2’
10. Button ‘ ’
11. Batteries (four AA alkaline) - not included
1
2
3
4
5
67
8 9 10
11
2

SYMBOLS
Symbols Meaning
Keep dry
Attention, consult accompanying
documents
Type BF Applied Part
Symbol for the marking of electrical
and electronics devices according to
Directive 2002/96/EC.
The device, accessories and the
packaging have to be disposed of
waste correctly at the end of the
usage. Please follow Local
Ordinances or Regulations for
disposal.
standby
3

TABLE OF CONTENTS
1 GENERAL
PRINCIPLE OF OPERATION
NEW TECHNOLOGIES USED
2 PREPARATION FOR MEASUREMENT
3 BATTERY INSTALLATION
4 CORRECT POSTURE FOR MEASUREMENT
5 ASSEMBLING THE CUFF
6 SETTING THE DATE AND TIME
7 CARRYING OUT A MEASUREMENT
IRREGULAR HEARTBEAT DETECTION
8 MEMORY FUNCTION
MEMORY RECALL
MEMORY CLEARANCE
9 WHO BLOOD PRESSURE CLASSIFICATION INDICATION
11 ERROR AND LOW BATTERY INFORMATION
12 MAINTENANCE, STORE, REPAIR AND RECYCLE
13 TROUBLESHOOTING
14 SPECIFICATIONS
15 LIMITED WARRANTY
16 BLOOD PRESSURE RECORD
17 MANUFACTURER’S DECLARATION
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Para instrucciones en Español, vease la pagina 25
4

GENERAL
Intended Use: This device is intended for the non-invasive measurement
of systolic and diastolic arterial blood pressure and pulse rate in adults
(age 15 and above).
Contraindication: Consult a physician if measurement is taken in children
or persons with arrhythmia, as errors may occur.
This instruction manual is intended to assist the user for safe and efficient
operation of the automatic digital talking blood pressure monitor
(hereinafter: device) model 1133. The device must be used in accordance
with the procedures described in the manual. Read and understand the
entire manual, especially the section <Tips for taking blood pressure
measurements>.
PRINCIPLE OF OPERATION
This device adopts the oscillometric technology with Fuzzy Algorithm to
measure the arterial blood pressure and pulse rate. The cuff is wrapped
around the arm and automatically inflated by the air pump. The sensor of
the device catches weak fluctuation of the pressure in the cuff produced by
extension and contraction of the artery of the arm in response to each
heartbeat. The amplitude of the pressure waves is measured, converted in
millimeters of the mercury column, and is displayed by digital value.
WARNING: This device cannot provide reasonable accuracy if used
or stored in the temperature or humidity beyond the range stated in
the <SPECIFICATIONS> section of this manual.
WARNING: DO NOT USE THE DEVICE OUTDOORS
TECHNOLOGIES USED
Fuzzy Algorithm is the processing algorithm, taking into account the
specialty of individual heartbeats, which provides higher accuracy of
measurement.
Proposition 65 Warning
WARNING: Cancer and Reproductive Harm -
www.p65warnings.ca.gov.
5

PREPARATION FOR MEASUREMENT
1. Do not conduct any measurements if the temperature is low (below 50°F /
10°C) or high (over 104°F / 40°C), or if the relative humidity is higher than
85%, as this can lead to inaccurate readings.
2. Take the measurement at room temperature in a quiet and stress-free
environment.
3. Do not move yourself or the unit during the measurement. Do not speak
during the measurement.
4. Blood pressure varies naturally depending on the time of day and is
affected by many factors. Blood pressure is usually highest at work and
reaches its lowest level during sleep.
5. Blood pressure measurements should be assessed by a physician or
trained healthcare professional who is familiar with your medical history. If
you use the unit and regularly record the results, keep your physician
informed of any changes in your blood pressure.
6. The performance of this device can be affected as severe arrhythmias
such as atrial or ventricular premature beats or atrial fibrillation are
presented during measurement.
7. The blood pressure measurements conducted with this unit are equivalent
to measurements obtained by a trained observer in accordance with the
values achieved using the cuff/stethoscope auscultation method and are
within the specified EN 1060-4 standard limits.
8. Patients with cardiovascular disease: take measurement under physician’s
instruction. Under no circumstances should you alter the dosage of any
drug prescribed by your physician!
9. Accurate measurement of blood pressure may be difficult in case of
arrhythmia, premature beat, atrial fibrillation, atreriosclerosis,
hypoperfusion, diabetes, pregnancy, nephropathy, weak pulse, or in
patients with obvious fluctuation of heart contraction rhythm. Consult a
physician to interpret your blood pressure readings.
6

10. It is necessary to keep quiet during the measurement to get an
accurate reading. Measurement should be conducted in a quiet
environment at room temperature. Don’t eat or smoke before a
measurement.
This device is supplied with the standard cuff which fits arm sizes
8.7-13.8 in. / 22-35 cm.
WARNING: Ensure the cuff size is appropriate for the person
whose blood pressure is being taken.
WARNING: Do not use any cuff other than the original cuff
contained in this kit!
11. Repeated measurements with an interval of 3 minutes are
recommended, so you can calculate the average to get a more
accurate measurement. Atherosclerosis patients may require a
longer interval (10-15 minutes) as elasticity of the patient’s vessels
decreases significantly with the disease. 10-15 minute interval is
also applicable for patients suffering from longtime diabetes.
CLASSICATION
• ME EQUIPMENT is not intended for use in an oxygen rich
environment or in the presence of flammable mixers.
• Internally powered equipment.
• Type BF applied part, cuff recognized as applied part.
7

BATTERY INSTALLATION
2. Close the battery compartment cover.
ASSEMBLING THE CUFF
1. Sit beside the table and let the table support your
arm as you take the measurement. Ensure the cuff
on the upper arm is at approximately the same
level as the heart as shown in Fig.1, and ensure
your feet lie flat on the ground and do not cross.
1. Insert the edge of the cuff approximately
2 in. / 5 cm into the D-ring as shown in Fig. 2.
CORRECT POSTURE FOR MEASUREMENT
1. Open the battery cover and install four AA alkaline batteries in the
battery compartment as indicated. Ensure the polarity is correct;
Fig.1
Fig.2
Replace the batteries when the replacement indication “ ”appears in
the display or nothing after “ ” button is pressed;
Do not use rechargeable batteries;
Replace all batteries simultaneously;
If the device will be unused for a long period of time, remove the batteries;
DO NOT leave worn batteries in the device.
8

2. Put the cuff on the left upper arm with the
tube pointing toward the palm. If
measurement on your left arm is difficult,
you may use the right arm for
measurement. In this case, be aware that
the readings may differ about 5-10 mmHg
between left arm and right arm.
3. Wrap cuff around your upper arm with the
lower edge of the cuff approximately
.8 - 1.2 in. / 2-3 cm above the elbow. The
mark <ARTERY> must be over the artery of
the upper arm.
4. Press the cuff to ensure it is attached
securely. The cuff should not be too tight or
loose. Two fingers should easily fit between
cuff and upper arm.
5. The mark <INDEX> on the cuff must point
to area <NORMAL> or <LARGE CUFF>.
This means the cuff size is correct. If mark
<INDEX> points to the area beyond area
<NORMAL> or <LARGE CUFF>, consult
your distributor to see whether you need
another size cuff.
6. Sometimes it is difficult to make the cuff fit
well, depending on the shape of the user’s
upper arm; the cone-shape assembly of
cuff is also acceptable.
7. If your clothes restrict the blood circulation
of your upper arm, or you roll your sleeve
up so as to result in such restriction, take
off your shirt to get an accurate
measurement if necessary.
9

4. When the year setup is finished, the month number will flash automatically.
Follow the same instruction as above to set month, date and time;
5. Press button ‘ ’ to finish the setup. If you wish to change the date
and time, repeat steps 2,3,4.
Note: When under the mode of Date/Time setting without any
operation, the device will automatically return to standby mode after
one minute.
SETTING THE DATE AND TIME
This function provides accurate measuring time for
each measurement. To get an accurate date and time,
preset the date and time correctly before the first use
of this device.
The operation procedure for presetting Date/Time is
as follows:
1. When the device is connected to power supply at
first, the display will show as in Fig.3;
2 Press and hold the button ‘M1’, then press the
button ‘ ’ , and the year number flashes as
shown in Fig.4;
3. Press button ‘M1’,or ‘M2’ to subtract or add the
number, and press button ‘ ’ for confirmation;
Fig.3
Fig.4
10

1. Assemble the cuff, then insert the tube plug into the air connector.
Before the measurement, take 3~5 deep breaths and relax. Don’t talk
or move your arm;
2. Press button ‘ ’, and all symbols will appear on display in 2 seconds
then ‘0 mmHg’ will appear on the screen. The pump begins to inflate
with display showing the pressure reading. Generally the pressure will
reach 190 mmHg as shown in Fig.5;
3. The pump stops inflating and the pressure begins to decrease
gradually, during which the user’s blood pressure and pulse will be
calculated as shown in Fig.6;
IRREGULAR HEARTBEAT DETECTION
When the device detects the irregular heartbeat or any excessive body
movement during measurement, ‘ ’ icon will flash on the screen as
shown in Fig.7.
WARNING: Contact your physician if
you see the ‘ ’ indicator frequently.
CARRYING OUT A MEASUREMENT
Fig.6
Fig.7
Fig.5
11

4. The cuff will deflate quickly and the blood pressure reading, pulse
reading will show in the display. Then the icon ‘ ’ will flash to remind
the user to record the reading as shown in Fig 8;
5. Press button ‘M1’ or button ‘M2’ to record the reading in the
corresponding memory; the measurement time will be displayed on the
screen alternately. If the user does not press the button, the reading
won’t be recorded;
6. Press the button ‘ ’ to turn off the device. Rest for at least 5 minutes
before taking another measurement. If the power supply is not
switched off and the device is unused for 3 minutes, the device will
switch off automatically.
AUTOMATIC INFLATION
There are four inflation pressure levels for this device: 190mmHg,
230mmHg, 270mmHg and 300mmHg. When 190mmHg is not enough or
arm movement occurs, the device will automatically inflate to higher
pressure to ensure a successful measurement. It is not a fault.
RAPID DEFLATION DURING MEASUREMENT
If you do not feel well during measurement or want to stop the
measurement for some reason, press the button ‘ ’. The device will
quickly release the air in the cuff and the device will be returned to
standby mode.
Fig.8
12

MEMORY CLEARANCE
When a measurement is finished or when the device is on
standby, hold down button ‘M1’ or ‘M2’ for at least 5
seconds, the display will show ‘CLR’ which means the
stored reading for ‘M1’ or ‘M2’ is removed as shown in
Fig.11.
Fig.9 Fig.10
Fig.11
MEMORY FUNCTION
MEMORY RECALL
1. The device can store 90 sets of readings respectively in ‘M1’ and ‘M2’, and
will automatically calculate the average value of the latest 3 readings for
‘M1’ and ’M2’. When the memory is full (90 sets of readings are stored),
the oldest reading will be replaced by a new one. Readings in memory
will not clear even if power supply is removed;
2. When a measurement is finished or the device is on standby, the user can
press button ‘M1’ or ‘M2’ to recall memory. Press button ‘M1’ or ‘M2’, the
display will show the average value of the latest 3 readings as shown in
Fig.9;
3. Press again, the display will show ‘01’, which means the latest reading,
then turns to another screen to show readings and measuring time as
shown in Fig.10;
4. Press again, the display will show ‘02’, which means the second to the
last reading.
13

Standards for assessment of high or low blood pressure, regardless of
age, have been established by World Health Organization (WHO) as
shown in the chart below：
WHO BLOOD PRESSURE CLASSIFICATION INDICATION
The indicator displays a segment, based on the current data,
corresponding to the WHO classification.
For example, if your blood pressure is 145mmHg (systolic pressure),
88mmHg (diastolic pressure), according to the World Health Organization
standard, your blood pressure level is Mild Hypertension.
Note: If the systolic blood pressure and the diastolic blood pressure fall
into different categories, the higher value should be taken for
classification.
14

INDICATION POSSIBLE REASON CORRECTION METHODS
The cuff is applied incorrectly
or the tube plug is inserted
loosely
Arm/hand movement or talking
occurred during measurement
Arrhythmia
Weak batteries
Ensure cuff is correctly applied and
tube plug is inserted tightly and repeat
the measurement
Follow the recommendations in this
manual precisely and repeat the
measurement
Consult your physician
Replace all four batteries with
new ones
ERROR AND LOW BATTERY INFORMATION
MAINTENANCE, STORING, REPAIR AND RECYCLING
1. Protect this device against moisture, direct sunlight, shock, solvent, alcohol and
gasoline.
2. Remove the batteries if the device is being stored for a long period of time.
WARNING: Keep the device and batteries away from children.
3. Keep sharp objects away from the cuff. Do not extend or twist the cuff.
4. Use only soft, clean cloth to clean the device.
5. The cuff is sensitive and must be handled with care. Clean the cuff with a clean, damp
cloth for daily maintenance.
6. To avoid cross-infection when sharing the cuff, sterilize the fabric cover of the cuff with a
soft, clean cloth moistened with a 3% solution of hydrogen peroxide. After long use
there will be a partial discoloration on the fabric surface of the cuff. Do not launder or
iron the cuff.
NOTICE: DO NOT wash the inner bladder.
7. Follow your local recycling rules and dispose of device and batteries at an appropriate
collection site.
8. We recommend having the device inspected every 2 years to ensure proper function,
accuracy and safety. Contact your distributor for maintenance.
WARNING: Do not open or repair the device. Contact your distributor for
maintenance.
15

SYMPTOM CHECK POINT REMEDY
No display after
installing batteries
Inflation stops and starts
The reading is extremely
low or high
Pulse rate is too low or
too high
Batteries deplete
quickly
Device automatically
turns off
Depleted batteries
Battery polarity incorrect
Dirty battery compartment
contact
Automatic inflation ensures
correct measurement
Talking or moving arm or
hand during measurement
Is the cuff at the same level
as the heart?
Cuff wrapped incorrectly
Moving arm during
measurement
Talking or moving arm or
hand during measurement
Did you talk or move your
arm or hand during
measurement?
Did you take measurement
right after exercise?
This is the result of automatic
turn-off feature
Faulty batteries
Replace all batteries with new
ones
Correct battery polarity
Clean battery terminals with dry
cloth
See<AUTOMATIC
INFLATION>.
Keep quiet and silent during
measurement
Ensure correct posture
Wrap the cuff correctly
Relax during measurement
Keep quiet and silent during
measurement
Keep quiet and silent during
measurement
Take measurement again after
resting for at least 5 minutes
This feature saves power
consumption of the device,
and it is not a fault
Use new alkaline batteries
of known manufacturers
TROUBLESHOOTING
16

SPECIFICATIONS
Inflation
Rapid deflation
Batteries
Memory
Upper arm circumference
Complete kit
Pollution Degrees
Overvoltage category
Altitude
Operation temperature and
humidity, air pressure
Transport and storage tempera-
ture and humidity, air pressure
Main body, cuff, gift box,
instruction manual
fits arm circumference 8.7-13.8 in. /
22-35 cm (standard cuff)
2 Users with 90 sets of memory each
Four AA 1.5V (not included)
Automatic electronic valve
Automatic by pump
-4°F to 122°F / -20°C to 50°C, ≤85% RH,
500hPa to 1060hPa
50°F to 104°F / 10°C to 40°C, ≤85% RH,
700hPa to 1060hPa
Category II
Degrees 2
≤6,652 ft / 2,000 m
Model
Size (dimensions LxWxH)
Weight (without batteries)
Measuring method
Extreme Pressure
Measuring range
Measuring accuracy
4.13 x 4.72 x 2.17 in. / 105 ×120 ×55 mm
1133
Approximately 11 oz. / 310 g
Oscillometry
40 to 260 mmHg(blood pressure)
40 to 160 beats/minute(pulse rate)
±3mmHg for static pressure
±5% of the reading for the pulse rate
300mmHg
17

LIMITED WARRANTY
SCOPE OF WARRANTY
GF Health Products, Inc. (“GF”) warrants to the original purchaser only that it will replace or repair components, at
GF’s sole discretion, that are defective in material or workmanship under normal use and service. All warranties are
conditioned upon the proper use of the products strictly in accordance with good commercial practice and
applicable GF instructions and manuals, including proper use and maintenance. To the extent that a component is
warranted by a third party, GF conveys all of its rights under that warranty to the original purchaser, to the extent
permitted. This limited warranty shall only apply to defects that are reported to GF’s customer service team within
the applicable warranty period and which, upon examination by GF or its authorized representative, prove to be a
warranty item. This limited warranty is not transferable.
The warranted components and time period are set forth below:
Digital Blood Pressure Monitor.......24 months
Cuff .................................................12 months
The applicable warranty period shall commence from date of shipment to the original customer, unless there is an
expiration date on the component in which case the warranty shall expire on the earlier of warranty period or the
expiration date.
OBTAINING WARRANTY SERVICE
This limited warranty shall only apply to defects that are reported to the Distributor from whom the Customer
purchased the product within the applicable warranty period. If there is not a Distributor, you must contact GF
directly by calling 1.770.368.4700, sending a fax request to 1.770.368.2386, or by e-mailing a request to
[email protected]. Specific directions will be provided by the Customer Service Representative. Failure to abide
by the specific directions will result in denial of the warranty claim.
EXCLUSIONS
The warranty does not cover and GF shall not be liable for the following:
1) Defects, damage, or other conditions caused, in whole or in part, by misuse, abuse, negligence, alteration,
accident, freight damage, tampering or failure to seek and obtain repair or replacement in a timely manner;
2) Products which are not installed, used, or properly cleaned and maintained as required in the official manual for
the applicable product;
3) Products considered to be of a non-durable nature including, but not limited to: casters, filters, fuses, gaskets,
lubricants, and charts;
4) Accessories or parts not provided by GF;
5) Charges by anyone for adjustments, repairs, replacement parts, installation or other work performed upon or in
connection with such products which are not expressly authorized in writing, in advance, by GF;
6) Any labor or shipping charges incurred in the replacement part installation or repair;
7) Costs and expenses of regular maintenance and cleaning; and
8) Representations and warranties made by any person or entity other than GF.
ENTIRE WARRANTY, EXCLUSIVE REMEDY AND CONSEQUENTIAL DAMAGES DISCLAIMER
THIS WARRANTY IS GF’S ONLY WARRANTY AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED. GF MAKES NO IMPLIED WARRANTIES OF ANY KIND INCLUDING ANY IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IF ANY MODEL OR SAMPLE WAS SHOWN
TO THE CUSTOMER, SUCH MODEL OR SAMPLE WAS USED MERELY TO ILLUSTRATE THE GENERAL TYPE
AND QUALITY OF THE PRODUCT AND NOT TO REPRESENT THAT THE PRODUCT WOULD NECESSARILY
CONFORM TO THE MODEL OR SAMPLE IN ALL RESPECTS. THIS WARRANTY IS LIMITED TO THE REPAIR
OR REPLACEMENT OF THE DEFECTIVE PARTS. GF SHALL NOT BE LIABLE FOR AND HEREBY DISCLAIMS
ANY DIRECT, SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES,
INCLUDING, BUT NOT LIMITED TO: DAMAGES FOR LOSS OF PROFITS OR INCOME, LOSS OF USE,
DOWNTIME, COVER, OR EMPLOYEE OR INDEPENDENT CONTRACTOR WAGES, PAYMENTS AND
BENEFITS.
The warranties contained herein contain all the representations and warranties with respect to the subject matter of
this document, and supersede all prior negotiations, agreements and understandings with respect thereto. The
recipient of this document hereby acknowledges and represents that it has not relied on any representation,
assertion, guarantee, warranty, collateral contract or other assurance, except those set out in this document. For
additional information on this product or this warranty, contact a GF Customer Service Representative.
NOTES:
1) Additional terms and conditions may apply.
2) Freight claims must be notated on the appropriate shipping documents and must be made with immediacy.
International, federal and state regulations govern specific requirements for freight claims. Failure to abide by
those regulations may result in a denial of the freight claim. GF will assist you in filing the freight claim.
3) Claims for any short shipment must be made within three (3) days of the invoice date.
18

DATE SYSTOLIC
(mmHg)
DIASTOLIC
(mmHg)
PULSE
(beats/minute)
BLOOD PRESSURE RECORD
19

The model 1133 Digital Blood Pressure Monitor is intended for use in the
electromagnetic environment specified below. The customer or the user of
the model 1133 Digital Blood Pressure Monitor should assure that is used
in such an environment.
Immunity
test IEC 60601
test level Compliance
level
Electrostatic
discharge
(ESD)IEC000-4-2
±6kV contact
±8kV air
±6 kV contact
±8 kV air
Floor should be wood, concrete or
ceramic tile. If floors 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 61000-4-5
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input linesIEC
61000-4-11
Power
frequency
magnetic field
IEC 61000-4-8
±1 kV
differential
mode
3 A/m 3 A/m
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
±1 kV
differential
mode
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 1133
Digital Blood Pressure Monitor
Equipment requires continued
operation during power mains
interruptions, it is recommended that
the 1133 Digital Blood Pressure
Monitor Equipment be powered from
an uninterruptible power supply or a
battery.
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital environment.
MANUFACTURER’S DECLARATION
Electromagnetic
environment-guidance
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