null  null
SAFETY INFORMATION
Symbol
Description
The Operation Guide Must be Read
Serial Number
Manufacturer
Direct Current
Manufacture Date
Type B Applied Parts
ENVIRONMENT PROTECTION - Waste electrical
products should not be disposed of with household waste. Please recycle where facilities exist.
Check with your local authority or retailer for
recycling advice.
Caution
COR1 LCD DISPLAY
Symbol
Description
Explanation
Systolic Blood
Pressure
High Pressure Result
Diastolic Blood
Pressure
Low Pressure Result
BPM
Heart Beats per Minute
Memory
See Page 14
Movement Error
Results in Inaccurate
Measurement
Low Battery
Replace Batteries
kPa
Measurement Unit
1kPa=7.5mmHG
mmHg
Measurement Unit
1mmHg=0.133kPa
Deflating
Cuff is Deflating
Current Time
YY:MM::DD, HH:MM
Grade
Grade of Blood Pressure
Arrhythmia
Irregular Heartbeat
Heartbeat
Heartbeat Detection
During Measurement
N
Memory
Hype.
G3
G2
G1
Norm.
Pul/min
Hypo.
Time/Date
Hypo.
Systolic
Diastolic
press
relax
blood discharging
artery
blood entering
vein
Blood Pressure
Category
Normal
Systolic
mm Hg (upper #)
Diastolic
mm Hg (lower #)
less than 120
and
less than 80
Pr-hypertensive
120-139
or
80-89
High Blood Pressure Stage 1
(Hypertension)
140-159
or
90-99
High Blood Pressure Stage 2
(Hypertension)
160 or higher
or
100 or higher
Higher than 180
or
Higher than 110
(Hypertension) Stage 1
(Hypertension) Stage 2
Hypertensive Crisis
(Emergency Care Needed)
(Emergency Care Needed)
SYS
135 mm Hg
DIA
85 mm Hg
PROBLEM
No Power
Low
Batteries
Error
Message
SYMPTOM
Display is dim or will
not light up.
+ Lo
Shown
on the
display
CHECK THIS
REMEDY
Batteries are exhausted
Replace with new batteries
Batteries are inserted
incorrectly
Insert batteries correctly
Low Battery
Replace with new batteries
E1 Shows
The cuff is not secure
Refasten the cuff and then
measure again
E2 Shows
The cuff is too tight
Refasten the cuff and then
measure again
E3 Shows
The pressure of the cuff
is excessive
Relax for a moment then
measure again
E10 or E11 Shows
The monitor detected
motion while measuring.
Movement can affect the
measurement. Relax then
measure again.
E20 Shows
The measurement
process does not
detect the pulse signal.
Loosen clothing on the arm
and them measure again.
E21 Shows
Measure incorrectly
Relax for a moment and
then measure again
A calibration error
occurred.
Retake the measurement.
If the problem persists,
contact the retailer or
our customer service
department for further
assistance. Refer to the
warranty for contact
information and return
instructions.
EExx,shows on the
display.
Power supply
2*AAA alkaline batteries (3V)
Display mode
Digital LCD V.A 44×31.5mm
Measurement mode
Oscillographic testing mode
Measurement range
Pressure: 0kpa - 40kpa (0mmHg-300mmHg)
Pulse value: 40 - 199 beats / minute
Accuracy
Pressure:
±3mmHg (≥ 200 mmHg,2%)
pulse value:±5%
Normal working condition
Temperature: 41°F - 104°F
Relative humidity ≤85%
Atmospheric Pressure: 86kPa to 105kPa
Storage & transportation
condition
Temperature:-24.8°F to 131°F
Temperature:-20°C to 55°C
Relative humidity: ≤ 90%RH
Measurement perimeter
of the wrist
Approximately 5.3 in - 8.4 in
Approximately 13.5 cm - 21.5 cm
Weight
Approximately 4.23 oz
(Excluding the dry cells)
External dimensions
Approx. 2.6 in x 2.9 in x 1.2 in
(68 mm ×75 mm ×31mm)
Attachment
2*AAA batteries; user manual
Mode of operation
Continuous operation
Degree of protection
Type B applied part
IP Classification
IPX0
Software version
V01
Device classification
Internally powered ME Equipment
Risk Management
ISO 14971:2012 Medical devices — Application of risk
management to medical devices.
Labeling
ISO 15223-1:2012 Medical devices. Symbols to be used with
medical device labels, labeling and information to be supplied.
General requirements
User manual
EN 1041: 2008 Medical equipment manufacturers to provide
information
General Requirements
for Safety
IEC 60601-1: 2005+A1:2012 Medical electrical equipment
- Part 1: General requirements for basic safety and essential
performance
Electromagnetic compatibility
IEC 60601-1-2:2007 Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
Performance and clinical
requirements
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or
automated
Software life-cycle processes
IEC 62304:2006+AC: 2008 Medical device software - Software
life cycle processes
Guidance and manufacturer’s declaration - electromagnetic emission
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF Emissions - CISPR 11
Group 1
The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF Emissions - CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Not
Applicable
Voltage Fluctuations / Flicker
Emissions IEC 61000-3-3
Not
Applicable
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 RF
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.
Separation distance according to frequency of transmitter (m)
Rated maximum output
power of transmitter (W)
150 kHz to
3,580 MHz
d=[
V1
] P
80 MHz to 800 MHz
d = 1.167 P
800 MHz to 2.5 GHz
d = 2.333 P
0.01
Not Applicable
0.117
0.233
0.1
Not Applicable
0.369
0.738
1
Not Applicable
1.167
2.333
10
Not Applicable
3.690
7.378
100
Not Applicable
11.67
23.33
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (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.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
Guidance and manufacturer’s declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment
Immunity Test
IEC 6060 1
Test Level
Compliance
Level
Electromagnetic environment
- guidance
Electrostatic discharge
(ES D) IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
`at least 30%.
Electrical fast transient
/ burst IEC 61000-4-4
±2 kV for
power supply
lines
N/A
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge IEC
61000-4-5
±1 kV line(s)
to line(s)
±2 kV line(s) to
earth
N/A
Mains power quality should be
that of a typical commercial or
hospital environment.
<5% UT
(>95% dip in
the UT)
for 0.5 cycles
N/A
40% UT
(60% dip in
the UT)
for 5 cycles
N/A
70% UT
(30% dip in
the UT)
for 25 cycles
N/A
<5% UT
(>95% dip in
the UT)
for 5 cycles
N/A
3 A/m
3 A/m
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power Frequency
(50Hz) magnetic field
IEC 61000-4-8
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the device requires continued
operation during power mains
interruptions, it is recommended
that the device be powered by
an uninterrupted power supply
or a battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
Note: UT is the a.c. mains voltage prior to application of the test level
Guidance and manufacturer’s declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Immunity Test
IEC 6060 1
Test Level
Compliance
Level
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
d=[
Not
applicable
3 V/m
3,5
V1
] P
d = 1.167 P 80 MHz to 800 MHz
d = 2.333 P 800 MHz to 2,5 G Hz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, should be less than the compliance
level in each frequency range.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1
NOTE 2
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broad-cast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the device is used
exceeds the applicable RF compliance level above, the device should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating
the device. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [ ]V/m.
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertisement