JOYTECH DBP-6281L Owner's Manual page 10

Electromagnetic Compatibility Information
Table 3
Guidance and declaration of manufacturer-electromagnetic immunity
Nowadays, many RF wireless equipments have being used in various healthcare
locations where medical equipment and/or systems are used. When they are
used in close proximity to medical equipment and/or systems, the medical
equipment and/or systems' basic safety and essential performance may be
affected. Arm-type Fully Automatic Digital Blood Pressure Monitor has been
tested with the immunity test level in the below table and meet the related
requirements of IEC 60601-1-2:2014. The customer and/or user should help
keep a minimum distance between RF wireless communications equipment and
this medical equipment and/or systems as recommended below.
Test
Band
frequency
Service
Modulation
(MHz)
(MHz)
385 380-390 TETRA 400 modulation
GMRS 460
450 430-470
± 5 kHz deviation
FRS 460
1 kHz sine
710
LTE
745
704-787
Band
modulation
13, 17
780
810
GSM 800/900,
TETRA 800,
870 800-960
iDEN 820,
modulation
CDMA 850,
LTE Band 5
930
1720
GSM 1800;
CDMA 1900;
GSM 1900;
1845
1700-1990 modulation
DECT;
LTE Band 1, 3,
4, 25; UMTS
1970
Bluetooth,WLAN,
Pulse modulation
2450 2400-2570
802.11 b/g/n,RFID
2450,LTE Band 7
5240
WLAN
modulation
5500 802.11
5100-5800
a/n
5785
Additional Notes
Important Instructions Before Use
1. WARNING: Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this equipment and
the other equipment should be observed to verify that they are operating normally.
2.WARNING: PORTABLE RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of
Fully Automatic Digital Blood Pressure Monitor, including cables specified by the
MANUFACTURER. Otherwise, degradation of the performance of this equipment could result.
3.The software identifier refer to the software evaluation report , and the file code is
NYRJ211220001.
4.verify manometer pressure accuracy:
In the power down state, press and hold the " START/STOP" button, and theninstall
the batteries. Until the LCD screen is full, release the " START/STOP" button.
When the LCD screen displays the double zero, the bloodpressure meter is in static state.
At this point, 500ml gas capacity, calibrated standard pressure gauge and manual pressure device
can be connected to the sphygmomanometer through the sleeve interface of the
sphygmomanometer, and manual pressure can be applied to the effective display range of the
sphygmomanometer, and then the difference between the reading of the sphygmomanometer and
that of the standard pressure gauge can be compared.This mode can be used to verify manometer
pressure accuracy.
5.Contraindications:
Product is not intended for infants or individuals who cannot express their intentions.
6.Indications for use:
The digital blood pressure monitor is used to measure blood pressure and pulse rate from
upper-arm.
7.The patient is the operator:
the PATIENT is an intended OPERATOR.
the PATIENT Do not carry out other maintenance operations except to replace the battery.
8.WARNING:
Do not modify this equipment without authorization of the manufacturer.
9. ESSENTIAL PERFORMANCE Maintenance advice:
Pressure calibration will be carried out when this product leaves the factory. Patients can use the
method described in the section "Verify Manometer Pressure Accuracy" to verify the accuracy.
If the accuracy deviation is large, please contact the manufacturer to recalibration.
10.Mechanical strength and resistance to heatThe resistance to heat will be retained by device
during the EXPECTED SERVICE LIFE of the ME EQUIPMENT.
Maximum
Immunity
Distance
power
test level
(m)
(W)
(V/m)
Pulse
0.3
27
1.8
18Hz
FM
2 0.3 28
Pulse
0.2 0.3
9
217Hz
Pulse
2 0.3
28
18Hz
Pulse
0.3 28
2
217Hz
2 0.3 28
217Hz
Pulse
0.3 9
0.2
217Hz
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Electromagnetic Compatibility Information
Table 4
Recommended separation distances between portable and mobile RF
communications equipment and the device
The device is intended for use in an electromagnetic environment in which
radiated therefore disturbances are controlled. The customer or the user of the
device can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications
equipment (transmitters) and the device as recommended below, according to
the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of
transmitter 80 MHz to 800 MHz
W
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE1 At 80 MHz and 800 MHz, the separation distance for th
frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects
and people.
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Additional Notes
11.Do not place the blood pressure monitor and cuff at will. It will cause asphyxiation if the child
swallows or twine around his neck.
12.The cuff and the case of the blood pressure monitor have been tested for biocompatibility and
do not contain allergenic or harmful materials.Please stop using it if allergy occurs during use.
13.Warning:
Non-professionals do not modify the equipment, otherwise it will make the equipment
measurement is not accurate.
14.Warning:
Do not expose the equipment for a long time, otherwise it will reduce the performance of the
equipment.
15.Warning:
This device is not used for children and pets
16.Clean:
The equipment can be cleaned by lay operator according to the cleaning procedures in the
instructions
17.Warning:
Do not use a damaged cuff for blood pressure measurement.
18.Warning:
When measuring with the cuff, if the tester feels seriously uncomfortable, press the button of the
blood pressure monitor to deflate the cuff, or remove the cuff directly from the arm.
19.Warning:
If an unexpected reading occurs, the operator can take several more measurements and consult a
doctor.
20.Warning:
This equipment is used outside the specified environment, may damage the equipment, and may be
inaccurate measurement.
21. Warning:
The Operator should not use the system and should inform the customer service,
if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES.
Warning:
22.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
Warning:
23.
Failure to use this equipment in the specified type of shielded location could result in degradation
of the performance of this equipment, interference with other equipment or interference with radio services
24.ME equipment not intended for use in conjunction with flammable agents "ME equipment not
intended for use in oxygen rich environment"
m
800 MHz to 2.7 GHz
0.12
0.23
0.38 0.73
1.2
2.3
3.8
7.3
12 23
e higher
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