Maintenance; Explanation Of Symbols On Unit; Troubleshooting; Electromagnetic Compatibility Information - Gima KD-735 Gebrauchsanweisung

Picture 7-3 Picture 7-4 Picture 7-5
b. And then, the most recent result will be displayed with date and time stamp.
See picture7-2. Followed by, the blood pressure and pulse rate will be shown
separately. Irregular heartbeat symbol (if any) will blink. See picture7-3&7-4.
Press "MEM" button again to review the next result. See picture7-5. In this
way, repeatedly pressing the MEM button displays the respective results
measured previously.
c. When displaying the stored results, the monitor will turn off automatically after
1 minute of no operation. You can also press the button "START" to turn off
the monitor manually.
8. Deleting measurements from the memory
When any result is displaying, keeping on pressing button "MEM" for three sec-
onds, all results in the current memory bank will be deleted after three "beep".
LCD will show picture 8, Press the button "MEM" or "START", the monitor will
turn off.
Picture 8
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 assess-
ment, and never change your treatment by yourself.
Classification of blood pressure for adults
Sistolic
(mmHg)
BLOOD PRESSURE
CLASSIFICATION
Severe Hypertension
160
Optimal
Moderate Hypertension
150 Normal
Mild Hypertension
High-Normal
140
High-normal BP
Grade 1 Hypertension
130
Normal BP
Grade 2 Hypertension
120
Grade 3 Hypertension
80 85 90 100 110 WHO/ISH Definitions and classification of blood pressure levels
Diastolic
(mmHg)
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 SPECIFICATIONS. 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 present 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
LCD Display shows The cuff position was Apply the cuff correctly
abnormal result 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
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
12. Troubleshooting (2)
PROBLEM POSSIBLE CAUSE SOLUTION
LCD shows low Low Battery Change the batteries
battery symbol
LCD shows "Er 0" Pressure system is unsta- Don't move and try again.
ble before measurement
LCD shows "Er 1" Fail to detect systolic
pressure
LCD shows "Er 2" Fail to detect diastolic
pressure
LCD shows "Er 3" Pneumatic system Apply the cuff correctly
blocked or cuff is too tight and try again
during inflation
LCD shows "Er 4 Pneumatic system leak-
age or cuff is too loose
during inflation
PROBLEM POSSIBLE CAUSE SOLUTION
LCD shows "Er 5" Cuff pressure above Measure again after five
300 mmHg minutes. If the monitor is still
abnormal, please contact the
LCD shows "Er 6" More than 3 minutes
local distributor or the factory
with cuff pressure above
15 mmHg
LCD shows "Er 7" EEPROM accessing error
LCD shows "Er 8" Device parameter
checking error
LCD shows "Er A" Pressure sensor
parameter error
No response when Incorrect operation Take out batteries for five
you press button or strong electromagnetic minutes, and then reinstall
or load battery interference all batteries
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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 water as this will result in damage to the monitor.
3. If this monitor is stored near freezing, allow it to acclimate to room
temperature before use.
4. Do not attempt to disassemble this monitor.
5. If you do not use the monitor for a long time, please remove the batteries.
6. It is recommended the performance should be checked every 2 years or after
repair. Please contact the service center.
7. Clean the monitor with a dry, soft cloth or a soft cloth squeezed well after
moistened with water, diluted disinfectant alcohol, or diluted detergent.
8. No component can be maintained by user in the monitor. The circuit
diagrams, component part lists, descriptions, calibration instructions, or other
information which will assist the user's appropriately qualified technical
personnel to repair those parts of equipment which are designated repairably
can be supplied.
9. 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.
10. It is recommended the cuff should be disinfected 2 times every week if need-
ed (For example, in hospital or in clinique). Wipe the inner side (the side con-
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tacts skin) of the cuff by a soft cloth squeezed after moistened with Ethyl
alcohol (75-90%), then dry the cuff by airing.
11. The monitor requires 6 hours to warm from the minimum storage temperature
between uses until the monitor is ready for its INTENDED USE when the
ambient temperature is 20 °C.
12. 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
13. Not servicing/maintenance while the monitor is in use.
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EXPLANATION OF SYMBOLS ON UNIT

Follow instructions for use
SBP DBP
mmHg mmHg
<120 <80
Caution: read instructions (warnings) carefully
120-129 80-84
130-139 85-89
Type BF applied part
140-159 90-99
160-179 100-109
≥180 ≥110
WEEE disposal
Medical Device complies with Directive 93/42/EEC
Manufacturer
Date of manufacture
Authorized representative in the European community
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Serial number
IP22 Covering Protection rate
Keep in a cool, dry place
Keep away from sunlight
Product code
Lot number
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ELECTROMAGNETIC COMPATIBILITY INFORMATION

Table 1
Emission
Phenomenon
RF emissions
Harmonic distortion
Voltage fluctuations
and flicker
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Table 2
Enclosure Port
Phenomenon
Electrostatic Discharge
Radiated RF EM field
Proximity fields from RF
wireless communications
equipment
Rated power frequency
magnetic fields
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26
27
28
29
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
30
Basic EMC Immunity test levels
standard
Home Healthcare
Environment
IEC 61000-4-2 ±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV
air
IEC 61000-4-3 10V/m
80MHz-2.7GHz
80% AM at 1kHz
IEC 61000-4-3 Refer to table 3
IEC 61000-4-8 30A/m
50Hz or 60Hz
Table 3
Proximity fields from RF wireless communications equipment
Test frequency Band (MHz) Immunity test levels
(MHz)
Professional healthcare facility
environment
385 380-390 Pulse modulation 18Hz, 27V/m
450 430-470 FM, ±5kHz deviation, 1kHz sine,
28V/m
710 704-787 Pulse modulation 217Hz, 9V/m
745
780
810 800-960 Pulse modulation 18Hz, 28V/m
870
930
1720 1700-1990 Pulse modulation 217Hz, 28V/m
1845
1970
2450 2400-2570 Pulse modulation 217Hz, 28V/m
5240 5100-5800 Pulse modulation 217Hz, 9V/m
5500
5785
Disposal: The product must not be disposed of along with other domes-
tic waste. The users must dispose of this equipment by bringing it to a
specific recycling point for electric and electronic equipment. For further
information on recycling points contact the local authorities, the local
recycling center or the shop where the product was purchased. If the
equipment is not disposed of correctly, fines or penalties may be applied
in accordance with the national legislation and regulations.
GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product. This product meets high quali-
tative standards both as regards the material and the production.
The warranty is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace free
of charge all the defected parts due to production reasons.
Labor costs and personnel traveling expenses and packaging not included.
All components subject to wear are not included in the warranty.
The repair or replacement performed during the warranty period shall not extend
the warranty. The warranty is void in the following cases: repairs performed by
unauthorized personnel or with non-original spare parts, defects caused by neg-
ligence or incorrect use. GIMA cannot be held responsible for malfunctioning on
electronic devices or software due to outside agents such as: voltage changes,
electro-magnetic fields, radio interferences, etc.
The warranty is void if the above regulations are not observed and if the serial
code (if available) has been removed, cancelled or changed.
The defected products must be returned only to the dealer the product was pur-
chased from. Products sent to GIMA will be rejected.
32918 / KD-735
ANDON HEALTH CO., LTD.
No. 3 JinPing Street, Ya An Road,
Nankai District,
Tianjin 300190, China
Made in China
Imported and distributed by:
Gima S.p.A. - Via Marconi, 1
20060 - Gessate (MI) Italy
iHealthLabs Europe SAS
36 Rue de Ponthieu,
75008, Paris, France
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