Finally the blood pressure and pulse rate will be calculated and displayed
on the LCD screen. The blood pressure classification indicator and Irregular
heartbeat symbol (if any) will blink on the screen. The result will be automati-
cally stored in the monitor.
d. After measurement, the monitor will turn off automatically after 1 minute of no
operation.
e. During measurement, you can press the "START/STOP" button to turn off the
monitor manually.
Note: Please consult a health care professional for interpretation of pressure
measurements.
7. Displaying stored results
a. In StandBy Mode, press "MEM" button, the monitor will display sign of current
group. The amount of results in current user memory zone will be displayed. See
picture 7. Press "START/STOP" button to switch group,press "MEM" to confirm
current group. Then LCD will display the average value of all results in the current
user memory zone. See picture 7-1. If no result stored in the current user memory
zone, LCD will display "0" for blood pressure and pulse rate. See picture 7-2.
b. Press "MEM" button, LCD will display the average value of all the results
which is measured from 5 o'clock to 9 o'clock in last 7 days in the current
user memory zone. See picture 7-3. If no result stored from 5 o'clock to 9
o'clock in last 7 days, LCD will display "0" for blood pressure and pulse rate.
See picture 7-4.
Picture 7
Picture 7-1
Picture 7-2
c. Press "MEM" button again, LCD will display the average value of all the
results which is measured from 18 o'clock to 20 o'clock in last 7 days in
the current user memory zone. See picture 7-5. If no result stored from 18
o'clock to 20 o'clock in last 7 days, LCD will display "0" for blood pressure
and pulse rate. See picture 7-6.
Picture 7-5
Picture 7-6
Picture 7-7
d. Press "MEM" button again, the most recent result will be displayed with date
and time stamp. See picture 7-7. Irregular heartbeat symbol (if any) and blood
pressure classification indicator will blink at the same time. If the monitor has
no result stored in the current user memory zone, the LCD will display "0" for
blood pressure and pulse rate. See picture 7-8.
e. Press "MEM" button again to review the next result. See picture 7-9. In this
way, repeatedly pressing the "MEM" button displays the respective results
measured previously.
f. When reviewing the results, the monitor will turn off automatically after 1 min-
ute of no operation. You can also press the "START/STOP" button to turn off
the monitor manually.
Note: When the monitor displaying the measurement, the classification color
indicator can be shown different color according to the systolic pressure and
diastolic pressure. Refer to the "ASSESSING HIGH BLOOD PRESSURE FOR
ADULTS" section.
8. Deleting measurements from the memory
When any result is displaying, keeping on pressing but-
ton "MEM" for three seconds, all results will be deleted.
Press the button "START/STOP", the monitor will turn off.
9. Assessing high blood pressure for adults
The following guidelines for assessing high blood pressure (without regard to
age or gender) have been established by the World Health Organization (WHO).
Please note that other factors (e.g. diabetes, obesity, smoking, etc.) need to be
taken into consideration. Consult with your physician for accurate assessment,
and never change your treatment by yourself.
Classification of blood pressure for adults
Systolic
(mmHg)
Severe Hypertension
BLOOD PRESSURE
180
CLASSIFICATION
Moderate Hypertension
160
Optimal
Mild Hypertension
Normal
140
High-normal BP
High-Normal
130
Grade 1 Hypertension
Normal BP
120
Grade 2 Hypertension
Grade 3 Hypertension
80
85
90
100
110
Diastolic
WHO/ISH Definitions and classification of blood pressure levels
(mmHg)
Note: It is not intended to provide a basis of any type of rush toward emergency
conditions/diagnosis based on the color scheme and that the color scheme is
meant only to discriminate between the different levels of blood pressure.
10. Technical alarm description
The monitor will show 'HI' or 'Lo' as technical alarm on LCD with no delay if
the determined blood pressure (systolic or diastolic) is outside the rated range
specified in part SPECIFICACIONS. In this case, you should consult a physician
or check if your operation violated the instructions.
The technical alarm condition (outside the rated range) is preset in the factory
and cannot be adjusted or inactivated. This alarm condition is assigned as low
priority according to IEC 60601-1-8.
The technical alarm is non-latching and need no reset. The signal displayed on
LCD will disappear automatically after about 8 seconds.
11. Troubleshooting (1)
PROBLEM
POSSIBLE CAUSE
SOLUTION
The cuff position was
Apply the cuff correctly
not correct or it was not
and try again
properly tightened
Body posture was not
Review the "BODY POSTURE
correct during testing
DURING MEASUREMENT"
sections of the instructions
and re-test
LCD Display shows
abnormal result
Speaking, arm or body
Re-test when calm and
movement, angry, excited
without speaking or moving
or nervous during testing
during the test
Irregular heartbeat
It is inappropriate for people
(arrhythmia)
with serious arrhythmia
to use this Electronic
Sphygmomanometer
19
12. Troubleshooting (2)
PROBLEM
LCD shows
battery symbol
LCD shows "Er 0"
LCD shows "Er 1"
LCD shows "Er 2"
LCD shows "Er 3"
LCD shows "Er 4"
20
LCD shows "Er 5"
LCD shows "Er 6"
LCD shows "Er 7"
LCD shows "Er 8"
Picture 7-3
Picture 7-4
LCD shows "Er A"
No response when
you press button or
load battery
MAINTENANCE
1.
Do not drop this monitor or subject it to strong impact.
2.
Avoid high temperature and solarization. Do not immerse the monitor in
Picture 7-8
Picture 7-9
water as this will result in damage to the monitor.
21
3. If this monitor is stored near freezing, allow it to acclimate to room tempera-
ture before use.
4.
Do not attempt to disassemble this monitor.
5. It is recommended the performance should be checked every 2 years or after
repair. Please contact the service center.
6. Clean the monitor with a dry, soft cloth or a soft cloth squeezed well after
moistened with water, diluted disinfectant alcohol, or diluted detergent.
7. No component can be maintained by user in the monitor. The circuit dia-
grams, component part lists, descriptions, calibration instructions, or other
information which will assist the user's appropriately qualified technical per-
sonnel to repair those parts of equipment which are designated repairably
can be supplied.
8. The monitor can maintain the safety and performance characteristics for a
minimum of 10,000 measurements or three years, and the cuff integrity is
maintained after 1,000 open–close cycles of the closure.
9. The monitor requires 6 hours to warm from the minimum storage tempera-
ture between uses until the monitor is ready for its INTENDED USE when the
ambient temperature is 20°C.
10. The monitor requires 6 hours to cool from the maximum storage temperature
between uses until the monitor is ready for its INTENDED USE when the
ambient temperature is 20°C.
11. Not servicing/maintenance while the monitor is in use.
22
12 It is recommended the cuff should be disinfected 2 times every week if need-
ed (For example, in hospital or clinic). Wipe the inner side (the side contacting
the skin) of the cuff with a soft cloth squeezed after being moistened with
Ethyl alcohol (75-90%), then dry the cuff by airing.
EXPLANATION OF SYMBOLS ON UNIT
SBP
DBP
Color
mmHg
mmHg
Indicator
<120
<80
green
120-129
80-84
green
130-139
85-89
green
140-159
90-99
yellow
160-179
100-109
orange
≥180
≥110
red
23
24
ELECTROMAGNETIC COMPATIBILITY INFORMATION
Table 1
Emission
Phenomenon
RF emissions
Harmonic distortion
Voltage fluctuations
and flicker
POSSIBLE CAUSE
SOLUTION
Low Battery
Change the batteries
Pressure system is unstable
before measurement
Don't move and try
Fail to detect systolic pressure
again
Fail to detect diastolic
pressure
Pneumatic system blocked or
Apply the cuff correctly
cuff is too tight during inflation
and try again.
If the monitor is still ab-
Pneumatic system leakage
normal, please contact
or cuff is too loose during
the local distributor or
inflation
the factory.
Cuff pressure above
300mmHg
More than 3 minutes with cuff
Measure again after five
pressure above 15 mmHg
minutes. If the monitor
Inner memory error
is still abnormal, please
contact the local
Device parameter checking
distributor or the factory
error
Pressure sensor parameter
error
Incorrect operation or strong
Take out batteries for
electromagnetic interference
five minutes, and then
reinstall all batteries
Follow instructions for use
Caution: read instructions (warnings) carefully
Type BF applied part
WEEE disposal
0197
Medical Device complies with Directive
93/42/EEC
Manufacturer
Date of manufacture
Authorized representative in the European
community
Serial number
IP20
Covering Protection rate
Keep in a cool, dry place
Keep away from sunlight
Product code
Lot number
Compliance
Electromagnetic
environment
CISPR 11 Group 1,
Home healthcare
Class B
environment
IEC 61000-3-2
Home healthcare
Class A
environment
IEC 61000-3-3
Home healthcare
Compliance
environment
25
Table 2
Enclosure Port
Phenomenon
Basic EMC
standard
Electrostatic Discharge
IEC 61000-4-2
Radiated RF EM field
IEC 61000-4-3
Proximity fields from RF
IEC 61000-4-3
wireless communications
equipment
Rated power frequency
IEC 61000-4-8
magnetic fields
26
Table 3
Proximity fields from RF wireless communications equipment
Test frequency
Band (MHz)
(MHz)
385
380-390
450
430-470
710
704-787
745
780
810
800-960
870
930
27
1720
1700-1990
1845
1970
2450
2400-2570
5240
5100-5800
5500
5785
Disposal: The product must not be disposed of along with other domestic
waste. The users must dispose of this equipment by bringing it to a specific
recycling point for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
28
29
30
IP20
32901 / KD-5923
ANDON HEALTH CO., LTD.
No. 3 JinPing Street, Ya An Road, Nankai District,
Tianjin 300190, China
Made in China
iHealthLabs Europe SAS
36 Rue de Ponthieu,
75008, Paris, France
31
Immunity test levels
Home Healthcare
Environment
±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air
10V/m
80MHz-2.7GHz
80% AM at 1kHz
Refer to table 3
30A/m
50Hz or 60Hz
32
Immunity test levels
Professional healthcare facility
environment
Pulse modulation 18Hz, 27V/m
FM, ±5kHz deviation, 1kHz sine,
28V/m
Pulse modulation 217Hz, 9V/m
Pulse modulation 18Hz, 28V/m
33
Pulse modulation 217Hz, 28V/m
Pulse modulation 217Hz, 28V/m
Pulse modulation 217Hz, 9V/m
34
35
36
0197