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
output power of
transmitter
W
Table 4
Separation distance according to frequency of transmitter
m
80 MHz to 800 MHz
800 MHz to 2.7 GHz
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
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.
e higher
Electromagnetic Compatibility Information
36
37
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 Arm-
type 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 verification and validation report , and the file code
is
xxxxxxxxxxxxx
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.Intended Use
The digital blood pressure monitor are reusable for clinical and home use and are non-invasive
blood pressure measurement systems designed to measure the systolic and diastolic blood pressure
and pulse rate of adolescents and adults individual by using a non-invasive technique, which is a
well-known technique in the market called the “oscillometric method”.
it can measure the systolic blood pressure, diastolic blood pressure and pulse rated on
up-arm,and the device is reusable for clinical or home use.
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.
.
Additional Notes
38
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.ME equipment not intended for use in conjunction with flammable agents
“
ME equipment not
intended for use in oxygen rich environment
”
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment)
This marking shown on the product indicates that it should not be disposed with other
household waste at the end of its life. To prevent potential harm to the environment or to
human health, please separate this product from other types of wastes and recycle it
responsibly. When disposing this type of product, contact the retailer where product was
purchased or contact your local government office for details regarding how this item can
be disposed in an environmentally safe recycling center.
Business users should contact their supplier and check the terms and conditions of the
purchasing agreement. This product should not be mixed with other commercial wastes
for disposal. This product is free of hazardous materials.
Additional Notes
Table 3
Electromagnetic Compatibility Information
35
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.
Service
1970
Immunity
test level
(V/m)
Distance
(m)
Band
(MHz)
0.3
Test
frequency
(MHz)
Modulation
Maximum
power
(W)
TETRA 400
0.2
9
5785
5500
5240
2400-2570
2450
800-960
28
0.3
2
704-787
0.2
710
0.3
27
0.3
1.8
450
9
28
0.3
2
745
780
810
870
GMRS 460
FRS 460
FM
±
5 kHz deviation
1 kHz sine
2
28
430-470
Pulse
modulation
18Hz
380-390
385
930
1720
1700-1990
2
1845
0.3
28
0.3
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation
18Hz
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation
217Hz
LTE
Band
13, 17
Pulse modulation
217Hz
WLAN
802.11
a/n
Pulse
modulation
217Hz
Bluetooth,WLAN,
802.11 b/g/n,RFID
2450,LTE Band 7
Pulse
modulation
217Hz
5100-5800
