Specifications - Gima JOLLY Gebrauchsanweisung

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
PROFESSIONAL MEDICAL PRODUCTS
JOLLY DIGITAL BLOOD PRESSURE MONITOR
Operation Guide
IMPORTANT INFORMATION .............................................................................3
CONTENTS AND DISPLAY INDICATORS .........................................................4
INTENDED USE .................................................................................................5
CONTRAINDICATION ........................................................................................5
PACKAGE CONTENTS .....................................................................................5
PRODUCT DESCRIPTION.................................................................................6

SPECIFICATIONS ..............................................................................................7

NOTICE .............................................................................................................8
SETUP AND OPERATING PROCEDURES ......................................................12
1. Battery loading ............................................................................................12
2. Clock and date adjustment .........................................................................13
3. Voice setting ...............................................................................................14
4. Connecting the cuff to the monitor .............................................................15
5. Applying the cuff .........................................................................................16
6. Body posture during measurement .............................................................17
7. Taking your blood pressure reading ............................................................18
8. Displaying stored results .............................................................................20
9. Deleting measurements from the memory ..................................................22
10. Assessing high blood pressure for adults .................................................22
11. Technical alarm description .......................................................................24
12. Troubleshooting (1) ....................................................................................25
13. Troubleshooting (2) ....................................................................................25
MAINTENANCE ...............................................................................................26
EXPLANATION OF SYMBOLS ON UNIT .........................................................28
ELECTROMAGNETIC COMPATIBILITY INFORMATION .................................30
WARRANTY INFORMATION ...........................................................................34
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 usu-
ally 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 of 1 to 1.5 minutes between measurements to al-
low 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 Sphygmomanometer 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
4x1.5 AAA batteries
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 voice function will ease the operation. The Electronic Sphygmomanome-
ters corresponds to the below standards: IEC 60601-1Edition 3.1 2012-08/
EN 60601-1:2006/A1:2013 (Medical electrical equipment -- Part 1: General re-
quirements for basic safety and essential performance), 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: Electromagnet-
ic compatibility - Requirements and tests), IEC80601-2-30:2009+AMD1:2013/
EN 80601-2-30:2010/A1:2015(Medical electrical equipment –Part 2-30: Particu-
lar 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: Supplementary requirements
for electro-mechanical blood pressure measuring systems); ISO81060-2:2013
(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated
Measurement Type).
SPECIFICATIONS
1. Product name: Arm Blood Pressure Monitor
2. Model: 32777 / KD-5920
3. Classification: Internally powered, Type BF applied part, IP20, No AP
or APG, Continuous operation
4. Machine size: Approx.150 mm × 95 mm × 41 mm (5 29/32" x 3 3/4" x 1 5/8")
5. Cuff circumference: 22-30 cm (8-11"), 30-42 cm (11-16") optional,
42-48 cm (16-18.2") optional
6. Weight: Approx. 235 g (8 9/32 oz.) (exclude batteries)
7. Measuring method: Oscillometric method, automatic inflation and measure-
ment
8. Memory volume: 4×30 times with time and date stamp
9. Power source: batteries: 4×1.5 V
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
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12. Environmental temperature for operation: 10°C~40°C (50°F~104°F)
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 100 times.
18. All components belonging to the pressure measuring system, including:
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 still, 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 at least 1 or 1.5 minutes between measurements 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 ecchymoma of your arm.
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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 therapy, 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 physician 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 meas-
urement.
10. Blood pressure measurements determined by this monitor are equivalent
to those obtained by a trained observer using the cuff/stethoscope ausculta-
tion method, within the limits prescribed by the American National Standard
Institute, 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
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WLAN unit, microwave oven, etc. It can't be used near active HF SURGICAL
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 Sphygmomanometers 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, otherwise
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
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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
television 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)
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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.
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SIZE AAA
2. Clock and date adjustment
a. Once you insert the battery, the Blood Pressure Monitor will enter Clock and
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. Press
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is blinking, press the button "MEM" to increase the number. Keep on pressing
the button "MEM", the number will increase fast.
Picture 2-1
d. You can turn off the monitor by pressing "START" button when the minute is
blinking, then the time and date is confirmed.
e. The monitor will turn off automatically after 1 minute of no operation with the
time and date unchanged.
f. Once you change the batteries, you should readjust the time and date.
3. Voice setting
a. Voice language setting: In Standby Mode, you can select the voice language
by keeping on press the button "MEM". Now LCD display "L0", "L1", "L2"
... "Ln" (n means the number of language) circularly. "L0" represents clos-
ing voice function, "L1" represents language 1, "L2" represents language 2,
...,"Ln" represents language n, and so on. You can select the wanted lan-
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guage by releasing button "MEM" when display the corresponding language
code.
b. Voice volume setting: Once you have selected a language, keeping on press-
ing the button "MEM" again. A column of bar will appear on the left side of
the LCD. The higher the bars, the louder the volume. Release button "MEM"
at your desirable volume for confirmation.
4. 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 connec-
tor is completely inserted to avoid air leakage during
blood pressure measurements.
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will be dis-
5. Applying the cuff
a. Pulling the cuff end through the medal loop (the
cuff is packaged like this already), turn it outward
(away from your body) and tighten it and close the
Velcro fastener. See picture 5-1.
b. Place the cuff around a bare arm 1-2cm above the
elbow joint.
c. If you place the cuff around left arm,position the
air tube in the middle of your arm in line with your
middle finger. See picture 5-2.
If you place the cuff around right arm, apply the
cuff so that the air tube is at the side of your el-
bow. See picture 5-3.
c. While seated, place palm upside in front of you on
a flat surface such as a desk or table. Position the
air tube in the middle of your arm in line with your
middle finger.
d. The cuff should fit comfortably, yet snugly around
your arm. You should be able to insert one finger
between your arm and the cuff.
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Note:
1. Please refer to the cuff circumference range in "SPECIFICATIONS" to make
sure that the appropriate cuff is used.
2. Measuring on same arm each time.
3. Do not move your arm, body, or the monitor and do not move the rubber tube
during measurement.
4. Stay quiet, calm for 5 minutes before blood pressure measurement.
5. Please keep the cuff clean. If the cuff becomes dirty, remove it from the mon-
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.
6. Do not place the cuff around your arm if the arm has any inflammation, acute
diseases, infections skin wounds.
6. Body posture during measurement
Sitting Comfortably Measurement
a. Be seated with your feet flat on the floor, and don't
cross your legs.
b. Place palm upside in front of you on a flat surface
such as a desk or table.
c. The middle of the cuff should be at the level of the
right atrium of the heart.
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Lying Down Measurement
a. Lie on your back.
b. Place your arm straight along your side with your
palm upside.
c. The cuff should be placed at the same level as
your heart.
7. Taking your blood pressure reading
a. After applying the cuff and your body is in a comfortable position, press the
"START" button. A beep is heard and all display characters are shown for self-
test. See Picture 7-1. Please contact the service center if segment is missing.
, replace all batteries with new ones.
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.
Date Adjustment Mode.
can be reached by pressing both the "START" and "MEM" button for 2 sec-
onds in Standby Mode.
the button "MEM" can change time format. Press the button "START" repeat-
edly, the year, month, day, hour and minute will blink in turn. While the number
Picture 2-2 Picture 2-3 Picture 2-4
Picture 3-1 Picture 3-2
Avoid compression or restriction of the connection tubing during measure-
ment, which may cause inflation error, or harmful injury due to continuous
cuff pressure.
Picture 7-1 Picture 7-2 Picture 7-3 Picture 7-4
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Picture 2-5 Picture 2-6
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16
Picture 5-1
Picture 5-2
Picture 5-3
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Picture 7-5