Tabla De Contenido; Contents And Display Indicators; Product Description; Setup And Operating Procedures - Gima KD-735 Manual De Instrucciones

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
PROFESSIONAL MEDICAL PRODUCTS
WRIST AUTOMATIC
BLOOD PRESSURE MONITOR
Operation Guide
ATTENTION:
The operators must carefully read
and completely understand the present manual
before using the product.
INDEX
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 .................................................... 13
1. Battery loading .......................................................................................... 13
2. Clock and date adjustment ....................................................................... 14
3. Connecting the cuff to the monitor ........................................................... 15
4. Applying the cuff ....................................................................................... 15
5. Body posture during measurement ........................................................... 16
6. Taking your blood pressure reading .......................................................... 17
7. Displaying stored results ........................................................................... 18
8. Deleting measurements from the memory ................................................ 20
9. Assessing high blood pressure for adults ................................................. 20
10. Technical alarm description ..................................................................... 21
11. Troubleshooting (1) .................................................................................. 22
12. Troubleshooting (2) .................................................................................. 23
MAINTENANCE ............................................................................................. 25
EXPLANATION OF SYMBOLS ON UNIT ....................................................... 27
ELECTROMAGNETIC COMPATIBILITY INFORMATION ............................... 29
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 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

LCD Display
Blood pressure level
Classification
indicator
Cuff
Memory indicator Date/Time display
Low battery indicator
Blood pressure level
Classification indicator
Irregular heartbeat symbol
Ready to initiate indicator
Note: The pictures in the manual are for reference only.
INTENDED USE
Fully Automatic Electronic Blood Pressure Monitor is for use by medical
professionals 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 wrist. The cuff circumference is limited
to 14cm-19.5cm (approx. 5 1/2"-7 11/16").
PACKAGE CONTENTS
• 1 Blood Pressure Monitor With Attached Wrist Cuff
• 1 Operation Guide
• 1 Plastic Bag
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-inva-
sively. The LCD display will show blood pressure and pulse rate. The most re-
cent 60 measurements can be stored in the memory with date and time stamp.
The Electronic Sphygmomanometers 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 80601-2-30:2010/A1:2015 (Medical elec-
trical 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 sphygmomanome-
ters - 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: Blood Pressure Monitor
2. Model: KD-735
3. Classification: Internally powered, Type BF applied part, IP22, No AP or APG,
Continuous operation.
4. Machine size: Approx. 85mm x 64.5mm x28mm
(3 11/32" x 2 17/32" x 1 3/32")
5. Cuff circumference:14cm - 19.5cm (5 1/2" - 7 11/16")
6. Weight: Approx. 110g (3 7/8 oz.) (exclude batteries)
7. Measuring method: Oscillometric method, automatic inflation and measure-
ment
8. Memory volume: 2x 60 times with time and date stamp
9. Power source: batteries: 2 ×1.5V
10. Measurement range:
Cuff pressure:
Systolic:
Diastolic:
Pulse rate:
11. Accuracy:
Pressure:
Pulse rate:
12. Environmental temperature for operation: 5°C~40°C (41°F~104°F)
2
13. Environmental humidity for operation: ≤90%RH
14. Environmental temperature for storage and transport:
-20°C~55°C (-4°F~131°F)
15. Environmental humidity for storage and transport: ≤90% 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 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 wrist 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 above 15 mmHg for longer than
3
3 minutes) of the bladder may cause ecchymoma of your wrist.
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;
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 physi-
cian 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 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
4
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
MEM botton
procedure of blood pressure measurement, a signal of ` ( ) ´ will be displayed.
Under this condition, the Electronic Sphygmomanometers can keep func-
START botton
tion, 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
Systolic pressure
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.
Diastolic pressure
Pulse rate display
16. This equipment has been tested and found to comply with the limits for a
(alternating)
Class B digital device, pursuant to part 15 of the FCC Rules.
5
These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses and
can radiate radio frequency energy and, if not installed and used in accord-
ance with the instructions, may cause harmful interference to radio commu-
nications. 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 equip-
ment 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. 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 interfer-
ence, and (2) this device must accept any interference received, including
interference that may cause undesired operation.
18. Measurements are not possible in patients with a high frequency of arrhyth-
mias.
19. 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.)
6
20. Motion, trembling, shivering may affect the measurement reading.
21. 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).
22. The device would not apply to the patients who use an artificial heart and
lung (there will be no pulse)
23. 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.
24. The patient is an intended operator.
25. Attention that changes or modification not expressly approved by the party
responsible for compliance could void the user's authority to operate the
equipment.
26. 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.
27. If you are allergic to plastic/rubber, please don't use this device.
SIZE AAA
0-300 mmHg
60-260 mmHg
40-199 mmHg
40-180 beats/minute
±3mmHg
Less than 60: ±3bpm
More than 60 (incl.): ±5%
7

SETUP AND OPERATING PROCEDURES

1. Battery loading
a. Open battery cover at the back of the monitor.
b. Load two "AAA" size batteries. Please pay attention to polarity.
c. Close the battery cover.
When LCD shows battery symbol , replace all batteries
with new ones.
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.
Avoid the battery fluid to get in your eyes. If it
should get in your eyes, immediately 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.
8

2. Clock and date adjustment

a. Once you install the battery or turn off the monitor, it will enter Clock Mode,
and LCD will display time and date by turns. See picture 2&2-1.
Picture 2 Picture 2-1
b. While the monitor is in Clock Mode, pressing both the "START" and "MEM"
button simultaneously, a beep is heard and the month will blink at first.
See picture 2-2. Press the button "START" repeatedly, the day, hour and min-
ute will blink in turn. While the number is blinking, press the button "MEM" to
increase the number. Keep on pressing the button "MEM", the number will
increase fast.
c. You can turn off the monitor by pressing "START" button when the minute is
blinking, then the time and date is confirmed.
d. The monitor will turn off automatically after 1 minute of no operation, with the
time and date unchanged.
e. Once you change the batteries, you should readjust the time and date.
9

3. Connecting the cuff to the monitor

The cuff is attached to the monitor when it
is packaged. Should the cuff become unat-
tached, align the two plugs and four brackets
of the cuff with the plug sockets and bracket
sockets of the monitor and press the cuff to
the monitor until the plugs and brackets are
securely attached.

4. Applying the cuff

a. Place the cuff around a bare wrist 1-2cm above the
wrist joint on the palm side of the wrist.
b. While seated, place the arm with the cuffed wrist in
front of your body on a desk or table with the palm
up.
If the cuff is correctly placed, you can read the LCD
display.
c. The cuff must be neither too tight nor too loose.
d. You can also take a measurement on your right
wrist as the picture
10
Note:
1. Please refer to the cuff circumference range in "SPECIFICATIONS" to make
sure that the appropriate cuff is used.
2. Measuring on same wrist each time.
3. Do not move your arm, body, or the monitor during measurement.
4. Stay quiet, calm for 5 minutes before blood pressure measurement.
5. Please keep the cuff clean. Clean the cuff by wet soft cloth and mild detergent
if the cuff becomes dirty. Do not remove the cuff from the monitor. Clean the
cuff after the usage of every 200 times is recommended.
6. Do not place the cuff around your wrist if the wrist has any inflammation, acute
diseases, infections skin wounds.

5. 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.
11

6. 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 6. Please contact the service center if segment is missing.
Picture 6 Picture 6-1 Picture 6-2
b. Then the monitor starts to seek zero pressure. See picture 6-1.
c. The monitor inflates the cuff until sufficient pressure has built up for a meas-
urement. Then the monitor slowly releases air from the cuff and carries out the
measurement. Finally the blood pressure and pulse rate will be calculated and
displayed on the LCD screen separately. Irregular heartbeat symbol (if any)
will blink. See picture 6-2&6-3. The result will be automatically stored in the
memory bank.
d. After measurement, the monitor will turn off automatically after 1 minute of
12
no operation. Alternatively, you can press the "START" button to turn off the
monitor manually.
e. During measurement, you can press the "START" button to turn off the moni-
tor manually.
Note: Please consult a health care professional for interpretation of pres-
sure measurements.

7. Displaying stored results

a. After measurement, you can review the results in the memory bank by press-
ing the "MEM" button. Alternatively, you can press "MEM" button in Clock
Mode to display the stored results. If it no result stored, LCD will show dashes
as picture 7, while press the button "MEM" or "START", machine will turn off.
If there are results in the
memory bank, the LCD will
display the amount of the
results in the memory bank.
See picture 7-1.
Picture 7
13
Battery
14
Picture 2-2
15
16
17
Picture 6-3
18
Picture 7-1 Picture 7-2