Owner's Manual

Table 4
Electromagnetic Compatibility Information
50
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
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 the
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.
higher
Table 2
Electromagnetic Compatibility Information
Guidance and de claration of m anufacture r-electro magnetic imm unity
The device is int ended for use in t he electroma gnetic envir onment speci fied below.
The customer or t he user of the dev ice should ass ure that it is use d in such an envir onm-
ent.
Floors sho uld be wood, concre te
or ceramic tile . If floors are
covered with sy nthetic mate rial,
the relative hu midity shoul d be
at least 30 %.
Electro magnetic env ironme nt
-guidanc e
Complian ce
level
IEC 60601
test level
IMMUNITY test
± 8 kV
contact
±2 kV,±4 kV,
±8 kV,
±15 kV air
Electrostat ic
discharge (ESD)
IEC 61000-4-2
Electrostat ic
transient/b urst
IEC 61000-4-4
± 2 kV for
power supp ly
lines
± 1 kV for
input/outpu t
lines
N/A
Surge
IEC 61000-4-5
± 1 kV
differe ntial
mode
± 2 kV
common
mode
N/A
Voltage dips,
short interrupti-
ons and voltage
variations on p-
ower supply in-
put lines
IEC 61000-4-11
< 5% UT
(>95% dip in
UT) for 0.5
cycle
40% UT
(60% dip in
UT) for 5
cycle
70% UT
(30% dip in
UT) for 25
cycle
<5% UT
(>95% dip in
UT) for 5
secretary
Power freq uen cy
(50/60 Hz)
magnetic fiel d
IEC 61000- 4-8
30 A/m; 50Hz
or 60Hz
Power freq uen cy magnetic fi elds
should be at leve ls character tic of a
typical locat ion in a typical c omme-
rcial or hospit al environme nt.
30 A/m; 50Hz
or 60Hz
N/A
± 8 kV
contact
±2 kV,±4 kV,
±8 kV,
±15 kV air
47
51
52
Additional Notes
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 , including cables specified
by the MANUFACTURER. Otherwise, degradation of the performance of this equipment
could result.
3.
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.
Wrist-type Fully Automatic Digital Blood Pressure Monitor
The software identifier refer to the software evaluation report , and the file code is
JYRJ200925002.
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.
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.
Table 2(continued)
Guidance and declaration of manufacturer-electromagnetic immunity
The device is intended for use in the electromagnetic environmen t spec ified below.
The customer or the user of the device should assure that it is used in such a n envi ronm-
ent.
Electromagnetic environment
-guidance
Compliance
level
IEC 60601
test level
IMMUNITY test
Electromagnetic Compatibility Information
48
Radiated RF EM
fields
IEC 61000-4-3
3V/m or 10 V/m
80MHz-2.7
Ghz 80%AM at
1kHz
3V/m or 10 V/m
80MHz-2.7
Ghz 80%AM at
1kHz
Port abl e and mobile R F com municati ons
equi pme nt should be u sed n o closer to an y
part o f the d evice, inc lud ing cables , tha n
the re com mended sep ara tion dista nce
calc ula ted from the e qua tion appli cab le to
the fr equ ency of the tr ans mitter.
Reco mme nded seper ati on distanc e 80 MH z
to 800 M Hz 80 0 MHz to 2.7 Ghz w her e P is
the ma xim um output po wer r ating of the
tran smi tter in watt s (W) a ccording t o the
tran smi tter manuf act urer and d is th e
reco mme nded separ ati on distanc e in
metr es (m ). Field str eng ths from fix ed RF
tran smi tters, as de ter mined by an
elec tro magnetic s ite s urvey, a should be
less t han t he complia nce l evel in each
freq uen cy range. In ter ference ma y occ ur in
the vi cin ity of equip men t marked wit h the
foll owi ng symbol:
Conducted
disturbances
Induced by RF
fields
IEC 61000-4-6
3 V in 0.15
MHz- 80 MHz
6 V in ISM
and/or amateur
radio bands
between 0.15
MHz and 80
MHz 80 %
AM at 1kHz
Port abl e and mobi le R F communi cat ion s
equi pme nt should be u sed no clo ser to a ny
part of t he device , in cluding c abl es, than the
reco mme nded sepa rat ion dista nce
calc ula ted from t he e quation a ppl icable to
the f req uency of t he t ransmitt er.
Reco mme nded sepe rat ion dista nce 80 M Hz
to 80 0 MH z 800 MHz t o 2. 7 Ghz where P is
the m axi mum outpu t po wer ratin g of the
tran smi tter in wa tts (W) accor din g to the
tran sm- itter man ufa cturer an d d i s th e
reco mme nded sepa rat ion dista nce in
metr es ( m). Field str engths fr om f ixe d RF
tran smi tters, as det ermined b y an
elec tro magnetic sit e survey, a shoul d be les s
than the complian ce l evel in ea ch f requency
rang e. I nterfere nce may occur in t he
vici nit y of equip men t marked w ith the
foll owi ng symbol :
3 V in 0.15
MHz- 80 MHz
6 V in ISM
and/or amateur
radio bands
between 0.15
MHz and 80
MHz 80 %
AM at 1kHz
Table 3
Electromagnetic Compatibility Information
49
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)
TETR A 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
GMR S 460
FRS 460
FM
± 5 k Hz dev iatio n
1 kH z sine
2
28
430-470
Pulse
modulation
18Hz
380-390
385
930
1720
1700-1990
2
1845
0.3
28
0.3
GSM 1 80 0;
CDMA 190 0;
GSM 1 90 0;
DECT ;
LTE Ban d 1, 3,
4, 25 ; U MTS
Pulse
modulation
18Hz
GSM 80 0/ 900,
TET RA 800,
iDEN 8 20 ,
CDMA 850,
LTE Band 5
Pulse
modulation
217Hz
LTE
Band
13, 17
Pulse mo dulatio n
217Hz
WLAN
802.11
a/n
Pulse
modulation
217Hz
Blu etoot h,WLA N,
802 .11 b/g/n ,RFID
245 0,LTE Band 7
Pulse
modulation
217Hz
5100-5800