Product Description - Gima KD-5923 Guía De Uso

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
PROFESSIONAL MEDICAL PRODUCTS
ANDON VALUE DIGITAL
BLOOD PRESSURE MONITOR
Operation Guide
IMPORTANT INFORMATION .............................................................................3
CONTENTS AND DISPLAY INDICATORS .........................................................4
INTENDED USE .................................................................................................5
PACKAGE CONTENTS .....................................................................................5
CONTRAINDICATION ........................................................................................5

PRODUCT DESCRIPTION.................................................................................6

SPECIFICATIONS ..............................................................................................7
NOTICE .............................................................................................................8
SETUP AND OPERATING PROCEDURES ......................................................12
1. Battery loading ............................................................................................12
2. Clock and date adjustment .........................................................................13
3. Connecting the cuff to the monitor .............................................................15
4. Applying the cuff .........................................................................................16
5. Body posture during measurement .............................................................17
6. Taking your blood pressure reading ............................................................18
7. Displaying stored results .............................................................................19
8. Deleting measurements from the memory ..................................................21
9. Assessing high blood pressure for adults ...................................................22
10. Technical alarm description .......................................................................23
11. Troubleshooting (1) ....................................................................................24
12. Troubleshooting (2) ....................................................................................25
MAINTENANCE ...............................................................................................26
EXPLANATION OF SYMBOLS ON UNIT .........................................................28
ELECTROMAGNETIC COMPATIBILITY INFORMATION .................................30
WARRANTY INFORMATION ...........................................................................33
IMPORTANT INFORMATION
Normal blood pressure fluctuation
All physical activity, excitement, stress, eating, drinking, smoking, body posture
and many other activities or factors (including taking a blood pressure measure-
ment) will influence blood pressure value. Because of this, it is mostly unusual to
obtain identical multiple blood pressure readings.
Blood pressure fluctuates continually day and night. The highest value usually
appears in the daytime and lowest one usually at midnight. Typically, the value
begins to increase at around 3:00AM, and reaches to highest level in the daytime
while most people are awake and active.
Considering the above information, it is recommended that you measure your
blood pressure at approximately the same time each day.
Too frequent measurements may cause injury due to blood flow interference,
please always relax a minimum moment of 1 to 1.5 minutes between measure-
ments to allow the blood circulation in your arm to recover. It is rare that you
obtain identical blood pressure readings each time.
CONTENTS AND DISPLAY INDICATORS
Note: The pictures in the manual are for reference only.
INTENDED USE
Fully Automatic Electronic Blood Pressure Monitor is for use by medical profes-
sionals or at home and is a non-invasive blood pressure measurement system
intended to measure the diastolic and systolic blood pressures and pulse rate of
an adult individual by using a non-invasive technique in which an inflatable cuff is
wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm
(approx. 8-18.2").
PACKAGE CONTENTS
1 Blood Pressure Monitor
1 Operation Guide
1 Arm cuff 22-30cm (8-11'')
1 Soft Storage Case
CONTRAINDICATION
It is inappropriate for people with serious arrhythmia to use this Electronic
Sphygmomanometer.
PRODUCT DESCRIPTION
Based on Oscillometric methodology and silicon integrated pressure sensor,
blood pressure and pulse rate can be measured automatically and non-invasive-
ly. The LCD display will show blood pressure and pulse rate. The most recent
4x30 measurements can be stored in the memory with date and time stamp.
The Electronic Sphygmomanometer corresponds to the below standards: IEC
60601-1Edition 3.1 2012-08/EN 60601-1:2006/A1:2013 (Medical electrical
equipment -- Part 1: General requirements for basic safety and essential perfor-
mance), IEC60601-1-2:2014/EN 60601-1-2:2015(Medical electrical equipment
-- Part 1-2: General requirements for basic safety and essential performance
- Collateral standard: Electromagnetic compatibility - Requirements and tests),
IEC80601-2-30:2009+AMD1:2013/EN IEC80601-2-30:2019 (Medical electrical
equipment –Part 2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers)EN 1060-1: 1995
+ A2: 2009 (Non-invasive sphygmomanometers - Part 1: General requirements),
EN 1060-3: 1997 + A2: 2009 (Non-invasive sphygmomanometers - Part 3: Sup-
plementary requirements for electro-mechanical blood pressure measuring sys-
tems); ISO81060-2:2013(Non-Invasive Sphygmomanometers - Part 2: Clinical
Validation Of Automated Measurement Type).
SPECIFICATIONS
1. Product name: Arm Blood Pressure Monitor
2. Model: 32901 / KD-5923
3. Classification: Internally powered, Type BF applied part, IP20, No AP or APG,
Continuous operation
4. Machine size: Approx. 107 mm × 80 mm × 52 mm
5. Cuff circumference: 22-30 cm (8-11"), 30-42 cm (11-16") optional,
42-48 cm (16-18.2") optional.
6. Weight: Approx. 166g (5 27/32 oz.) (exclude batteries and cuff)
7. Measuring method: oscillometric method, automatic air inflation and meas-
urement
8. Memory volume: 4×30 times with time and date stamp
9. Power source: batteries: 4×1.5V
10. Measurement range:
Cuff pressure: 0-300 mmHg
Systolic: 60-260 mmHg
Diastolic: 40-199 mmHg
Pulse rate: 40-180 beats/minute
11. Accuracy: Pressure: ±3 mmHg
Pulse rate: Less than 60: ±3bpm
More than 60 (incl.): ±5%
precision of the displayed values: 1mmHg
12. Environmental temperature for operation: 10°C~40°C (50°F~104°F)
2
13. Environmental humidity for operation: ≤85% RH
14. Environmental temperature for storage and transport:
-20°C~50°C (-4°F~122°F)
15. Environmental humidity for storage and transport: ≤85% RH
16. Environmental pressure: 80kPa-105kPa
17. Battery life: Approx 270 times.
18. All components belonging to the pressure measuring system, including ac-
cessories: Pump, Valve, LCD, Cuff, Sensor
Note: These specifications are subject to change without notice.
NOTICE
1. Read all of the information in the operation guide and any other literature in
the box before operating the unit.
2. Stay quiet, calm and rest for 5 minutes before blood pressure measurement.
3. The cuff should be placed at the same level as your heart.
4. During measurement, neither speak nor move your body and arm.
5. Measuring on same arm for each measurement.
6. Please always relax a minimum moment of 1 to 1.5 minutes between meas-
urements to allow the blood circulation in your arm to recover.
Prolonged over-inflation (cuff pressure exceed 300 mmHg or maintained
above15 mmHg for longer than 3 minutes) of the bladder may cause ecchy-
moma of your arm.
3
7. Consult your physician if you have any doubt about below cases:
1) The application of the cuff over a wound or inflammation diseases;
2) The application of the cuff on any limb where intravascular access or ther-
apy, or an arterio-venous (A-V) shunt, is present;
3) The application of the cuff on the arm on the side of a mastectomy or
lymph node clearance;
4) Simultaneously used with other monitoring medical equipments on the
same limb;
5) Need to check the blood circulation of the user.
8. This Electronic Sphygmomanometers is designed for adults and
should never be used on infants or young children. Consult your phy-
sician or other health care professionals before use on older children.
9. Do not use this unit in a moving vehicle, This may result in erroneous
measurement.
10. Blood pressure measurements determined by this monitor are equivalent to
those obtained by a trained observer using the cuff/stethoscope auscultation
method, within the limits prescribed by the American National Standard Insti-
tute, Electronic or automated sphygmomanometers.
11. Information regarding potential electromagnetic or other interference be-
tween the blood pressure monitor and other devices together with advice re-
garding avoidance of such interference please see part ELECTROMAGNET-
IC COMPATIBILITY INFORMATION. It is suggested that the blood pressure
monitor be kept at least 30 cm away from other wireless devices, such as
WLAN unit, microwave oven, etc.It can't be used near active HF SURGICAL
4
EQUIPMENT and the RF shielded room of an ME SYSTEM for magneticres-
onance imaging, where the intensity of EM DISTURBANCES is high.
12. If Irregular Heartbeat (IHB) brought by common arrhythmias is detected in
the procedure of blood pressure measurement, a signal of
played. Under this condition, the Electronic Sphygmomanometer can keep
function, but the results may not be accurate, it's suggested that you consult
with your physician for accurate assessment.
There are 2 conditions under which the signal of IHB will be displayed:
1) The coefficient of variation (CV) of pulse period >25%.
2) The difference of adjacent pulse period≥0.14s, and the number of such
pulse takes more than 53 percentage of the total number of pulse.
13. Please do not use the cuff other than supplied by the manufacturer, other-
wise it may bring biocompatible hazard and might result in
measurement error.
14. The monitor might not meet its performance specifications or cause
safety hazard if stored or used outside the specified temperature and
humidity ranges in specifications.
15. Please do not share the cuff with other infective person to avoid
cross-infection.
16. This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmful interference
in a residential installation. This equipment generates, uses and can radiate
5
radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or tel-
evision reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one or more
of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
17. Measurements are not possible in patients with a high frequency of arrhyth-
mias.
18. The device is not intended for use on neonates, children or pregnant women.
(Clinical testing has not been conducted on neonates, children or pregnant
women.)
19. Motion, trembling, shivering may affect the measurement reading.
20. The device would not apply to the patients with poor peripheral circulation,
noticeably low blood pressure, or low body temperature (there will be low
blood flow to the measurement position).
21. The device would not apply to the patients who use an artificial heart and
lung (there will be no pulse).
6
22. Consult your physician before using the device for any of the following con-
ditions: common arrhythmias such as atrial or ventricular premature beats or
atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, pre-eclampsia,
renal diseases.
23. The patient is an intended operator.
24. Attention that changes or modification not expressly approved by the party
responsible for compliance could void the user's authority to operate the
equipment.
25. Swallowing batteries and/or battery fluid can be extremely dangerous. Keep
the batteries and the unit out of the reach of children and disabled persons.
26. If you are allergic to plastic/rubber, please don't use this device.
SETUP AND OPERATING PROCEDURES
1. Battery loading
a. Open battery cover at the back of the monitor.
b. Load four "AAA" size batteries. Please pay attention to polarity.
c. Close the battery cover.
When LCD shows battery symbol
Rechargeable batteries are not suitable for this monitor.
Remove the batteries if the monitor will not be used for a month or more to avoid
relevant damage of battery leakage.
7
2. Clock and date adjustment
a. At first the Blood Pressure Monitor is totally off, once you insert the battery,
SIZE AAA
b. If the time of the device is already set and need to be changed, adjustment
c. In Clock and Date Adjustment Mode , the time format will blink at first , see
d. Press the button "START/STOP" repeatedly, the year (first usage: default is
8
e. During adjusting clock and date, the monitor will go back to Standby Mode
f.
9
Note:
2.1
2.2
hour format.
Table 1
3. Connecting the cuff to the monitor
Insert the cuff tubing connector into the socket in the left side of the monitor.
Make certain that the connector is completely inserted to avoid air leakage dur-
ing blood pressure measurements.
10
will be dis-
4. Applying the cuff
a. Pulling the cuff end through the medal loop (the
b. Place the cuff around a bare left arm 1-2cm above
c. If you place the cuff around left arm,position the
d. While seated, place palm upside in front of you on
e. The cuff should fit comfortably, yet snugly around
11
Note:
• Please refer to the cuff circumference range in "SPECIFICATIONS" to make
• Measure on the same arm each time.
• Do not move your arm, body, or the monitor and do not move the rubber tube
• Stay quiet, calm for 5 minutes before blood pressure measurement.
• Please keep the cuff clean. If the cuff becomes dirty, remove it from the mon-
• Do not place the cuff around your arm if the arm has any inflammation, acute
5. Body posture during measurement
Sitting Comfortably Measurement
a. Be seated with your feet flat on the floor, and don't
b. Place palm upside in front of you on a flat surface
12
c. The middle of the cuff should be at the level of the right atrium of the heart.
Lying Down Measurement
a. Lie on your back.
b. Place your left arm straight along your side with
c. The cuff should be placed at the same level as
6. Taking your blood pressure reading
a. After applying the cuff and your body is in a comforta-
b. Then the current memory bank (
, replace all batteries with new ones.
c. Then the monitor inflates the cuff until sufficient pres-
Avoid the battery fluid to get in your eyes. If it should get in your eyes, im-
mediately rinse with plenty of clean water and contact a physician.
The negative terminal of the battery needs to be compressed into the bat-
tery compartment properly after horizontal compression of the negative
electrode. The battery is in contact with the spring
Make sure the battery cover is intact and not damaged before installing
the battery.
The monitor, the batteries and the cuff, must be disposed of according to
local regulations at the end of their usage.
the Blood Pressure Monitor will enter Clock and Date Adjustment Mode.
can be reached by pressing both the "START/STOP" and "MEM" button for 3
seconds in Standby Mode.
picture2-1. The default time format is 24h and the default clock and date is
2016-1-1 1:00.
2016, range is 2016~2099), month, day, hour and minute will blink in turn, see
picture 2- 2& 2-3 & 2-4 & 2-5 & 2-6. While the number is blinking, press the
button "MEM" to increase the number, keep on pressing the button "MEM",
the number will increase faster.
Picture 2-1 Picture 2-2
Picture 2-4 Picture 2-5
automatically when no button will be pressed within 30 seconds.
You can turn off the monitor by pressing "START/STOP" button when the
minute is blinking, then the time and date is confirmed.
The clock format could be set by user.
Table 1 instructs the conversion relations between 24 hour format and 12
24 hour format 12 hour format 24 hour format
0:00 12:00 AM 12:00
1:00 1:00 AM 13:00
2:00 2:00 AM 14:00
3:00 3:00 AM 15:00
4:00 4:00 AM 16:00
5:00 5:00 AM 17:00
6:00 6:00 AM 18:00
7:00 7:00 AM 19:00
8:00 8:00 AM 20:00
9:00 9:00 AM 21:00
10:00 10:00 AM 22:00
11:00 11:00 AM 23:00
Avoid compression or restriction of the con-
nection tubing during measurement, which
may cause inflation error, or harmful injury due
to continuous cuff pressure.
cuff is packaged like this already), turn it outward
(away from your body) and tighten it and close the
Velcro fastener. See picture 4-1.
the elbow joint.
air tube in the middle of your arm in line with your
middle finger. See picture 4-2.
If you place the cuff around right arm, apply the
cuff so that the air tube is at the side of your
elbow. See picture 4-3.
a flat surface such as a desk or table. Be careful
not to rest your arm on the air tube, or otherwise
restrict the flow of air to the cuff.
your arm. You should be able to insert one finger between your arm and the
cuff.
sure that the appropriate cuff is used.
during measurement.
itor and clear it by hand in a mild detergent, then rinse it thoroughly in cold
water. Never dry the cuff in clothes dryer or iron it. Clean the cuff after the
usage of every 200 times is recommended.
diseases, infections skin wounds.
cross your legs.
such as a desk or table.
your palm upside.
your heart.
ble position, press the "START/STOP" button. All dis-
play characters are shown for self-test. You can check
the LCD display according to the right picture.
Please contact the service center if segment is missing.
, , or ) is displayed.
Press "MEM" button to change over to other bank.
Confirm your selection by pressing "START" button.
The current bank can also be confirmed automatically
after 5 seconds with no operation.
sure has built up for a measurement. Then the monitor
slowly releases air from the cuff and carries out the
measurement.
13
14
Picture 2-3
Picture 2-6
15
12 hour format
12:00 PM
1:00 PM
2:00 PM
3:00 PM
4:00 PM
5:00 PM
6:00 PM
7:00 PM
8:00 PM
9:00 PM
10:00 PM
11:00 PM
16
Picture 4-1
Picture 4-2
Picture 4-3
17
18