User's Manual

Press the Up or Down button to select the option to be adjusted, Press the left or right button to change the value.The device adopts
24-hour clock.
A set year: set the year
B set month: set the month
C set day: set the day
D set hour: set the hour
E set minute: set the minute
5.3.4 Alarm setting
In the main menu interface, move the choice bar to "Alarm" item, then press power/confirm button to enter the password interface of
Figure 12.
Figure 12.password interface Figure 13. Alarm menu
Inputting password (Press the Up or Down button to select number, Press the left or right button to adjust input position, The factory
default password is 7762.), then press power/confirm button to enter the alarm menu of Figure 13.
Press the Up or Down button to select the option to be adjusted, Press the left or right button to change the value.
A SpO
2
HI (%): upper limit alarm for SpO
2
over-limit.
B SpO
2
LO (%): lower limit alarm for SpO
2
over-limit.
C PR HI (bpm): upper limit alarm for PR over-limit.
D PR LO (bpm): lower limit alarm for PR over-limit.
E Alarm Volume: set the alarm volume, adjustable range: 1 ~ 3.
F SpO
2
Alarm: set the SpO
2
alarm, ―on‖: turn on the SpO
2
alarm, ―off‖: turn off the SpO
2
alarm.
G PR Alarm: set the PR alarm, ―on‖: turn on the PR alarm, ―off‖: turn off the PR alarm.
Lower limit can not exceed the upper limit, and the upper limit can not be lower than the lower limit when adjusting the values. SpO
2
range: 0 % ~ 100 %, PR range: 0 bpm ~ 254 bpm.
Please refer to Chapter 10 for the initial value of over-limit prompt.
5.3.5 Record setting
In the main menu interface, move the choice bar to "Record" item,then press power/confirm button to enter Figure 14. It indicates
that the device is storing, when the red dot ―●‖ at the top of the screen flashes.
Figure 14. Record Menu Figure 15. Record Menu
Press the Up or Down button to select the option to be adjusted, Press the left or right button to change the value.
A Mode: record mode selection, including: ―Auto‖ and ―Manual‖ mode, manual mode show as Figure 14, auto mode show as Figure
15.
Under ―Manual‖ mode, select to turn on or off memory by ―Record‖.
Auto record: start recording after stable data appear, pull out the finger to finish recording a group of data (99 group of data at most), the
total duration does not exceed 72 hours.
Manual record: after manual storage is started, the storage state needs to be terminated manually to complete a group of store, store up to
24-hour data.
When the storage space is full, it displays "Memory is full" on the screen.
Note: Under manual mode, when “Record” is “ON”, the device will prompt to clear the data stored last time.
It will display ―Recording...‖ when there is no operation under record state for 15s, then it will enter energy saving mode after several
seconds, pressing the "menu/return button", the device would return to the measure interface; pressing power/confirm button, it will
display ―Recording‖; pressing any button(power/confirm and menu/return button excluded), it will be no response.
B Seg: data segment.
C DataReview: view record data (see figure 3).
D Delete All: delete all records.
5.3.6 Password setting
In the main menu interface, move the choice bar to "Password" item, then press power/confirm button to enter the password interface
of Figure 16.
Figure 16. password interface Figure 17.new password interface
Press the Up or Down button to select number, Press the left or right button to adjust input position(The factory default password is
7762), then pressing the power/confirm button, you can set a new password of Figure 17.
NOTE: The new password needs to be enter twice, the first time is to set, the second time is to confirm.
5.4 Data upload
5.4.1 Wired transmission
Connect the device to computer by the USB cable, upload the data after connecting with the PC software properly, refer to ―Software
operating instruction‖ for details.
5.4.2 Bluetooth transmission (selection function)
Turn on the device Bluetooth and the PC software to upload data, refer to ―Software operating instruction‖ for details.
5.5 Charging
Power adapter can be selected to charge for the device.
When the device is closed and the battery is charging up, short press power/confirm button and the device will display dynamic charge icon,
it means that the device is charging up. When the device is open and the battery is charging up, the battery status icon on the right top will
display state of charge. It means that the device is charging up. When the battery status is full, the charging has been finished.
5.6 Reset
Long press the power/confirm button for several seconds, and press the menu/return button at the same time to reset.
6 Maintain, Transport and Storage
6.1 Cleaning and disinfection
Please turn off the device and disconnect it from the power, do not immerse it into liquid.
Use 75% alcohol to wipe the device enclosure, nature dry or clean it with clean and soft cloth. Do not spray any liquid on the device directly,
and avoid liquid penetrating into the device.
6.2 Maintenance
A. Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patients safety and
monitoring performance. It is recommended that the device should be inspected weekly at least. When there is obvious damage, stop using it.
B. Please clean and disinfect the device before/after using it according to the User Manual (6.1).
C. Please charge the battery in time when low battery appears.
D. Recharge the battery soon after over-discharge. The device should be recharged every three months when it is not used for some time. It
can extend the battery life following this guidance
E. The device need not to be calibrated during maintenance.
6.3 Transport and Storage
A. The packed device can be transported by ordinary conveyance or according to transport contract. During transportation, avoid strong
shock, vibration and splashing with rain or snow, and it can not be transported mixed with toxic, harmful, corrosive material.
B. The packed device should be stored in room with no corrosive gases and good ventilation. Temperature: -40°C ~ + 60°C; Relative
humidity: ≤95%.
7 Troubleshooting
Trouble
Possible Reason
Solution
The values can not be
displayed normally or
stably.
1.The finger is not properly inserted.
2.The finger is shaking or the patient is moving
3.The device is not used in environment required by
the manual.
4.The device works abnormally.
1.Please insert the finger properly and measure
again.
2.Let the patient keep calm.
3.Please use the device in normal environment.
4.Please contact the after-sales.
The device can not be
turned on
1.Low battery or the battery is drained away.
2.The device works abnormally.
1.Please charge the battery.
2.Please contact the after-sales.
The display disappears
suddenly
1.The device enters into the energy saving mode.
2.Low battery.
3.The device works abnormally.
1.Normal.
2.Please charge the battery.
3.Please contact the after-sales.
The device can not be used
for full time after charge.
1.The battery is not charged fully.
2.The device works abnormally.
1.Please charge the battery.
2.Please contact the after-sales.
The battery can not be full
charged even after 10
hours charging time.
The device works abnormally.
Please contact the local after-sales.
The data can not be stored.
1.The device is not operated according to the manual.
2.The device works abnormally.
1.Please operate the device according to the
manual.
2.Please contact the after-sales.
8 Key of Symbols
Symbols
Meaning
Symbols
Meaning
Caution, consult accompanying
documents
PRbpm
Pulse rate (bpm)
Type BF applied part
%SpO
2
Pulse oxygen saturation (%)
Manufacturer
Fully charged
Serial number
Use-by date
Recycling garbage
WEEE (2012/19/EU)
USB
IP22
It means this pulse oximeter is protected
against harmful effects of dripping water
when tilted at 15°
Humidity limitation
Temperature limitation
This way up
Atmospheric pressure limitation
Keep away from rain
Fragile, handle with care
Close the pulse sound
Low battery
Alarm on
Alarm pause
Open the pulse sound
Alarm off
Manufacture Date
Menu/Return button
Finger Out
The finger is not inserted
Power/Confirm button
Sensor Fault
Probe failure
Recyclable
PI%
Perfusion index
P/N
Material code
LOT
Batch No.
Bluetooth icon
(Bluetooth device)
1. The finger clip falls off ( no finger inserted)
2. Probe error
3. Signal inadequacy indicator
Sensor Off
The probe is disconnected.
●
Recording
left/alarm confirmation button
right/alarm pause button
European Representative
DataReview
This item is compliant with Directive 93/42/EEC of 14 june 1993 concerning medical devices; Including, at 21
march 2010, the amendments by Council Directive 2007/47/EC.
Note：Your device may not contain all the following symbols.
9 Specification
SpO
2
[see note 1]
Display range
0% ~ 100%
Measured range
0% ~ 100%
Accuracy [see note 2]
70% ~ 100%: ±2%;
0% ~ 69%: unspecified.
Resolution
1%
PR
Display range
30 bpm ~ 250 bpm
Measured range
30 bpm ~ 250 bpm
Accuracy [see note 3]
±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm and ±2% during the pulse rate range of
100 bpm ~ 250 bpm.
Resolution
1 bpm
PI (selection function)
Display range
0% ~ 20%
Measured range
0% ~ 20%
Accuracy
1% ~ 20% : ±1%
0% ~ 0.9%: ±0.2%
Resolution
0.1%
Accuracy under low perfusion
[see note 4]
Low perfusion 0.4%:
SpO
2
: ±4%;
PR: ±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm and ±2% during the pulse rate
range of 100 bpm ~ 250 bpm.
Light interference
Under normal and ambient light conditions, the SpO
2
deviation ≤ 1%
Pulse intensity
Continuous bar graph display, the higher display indicates the stronger pulse.
Upper and lower limit of alarm limits
SpO
2
0% ~ 100%
PR
0 bpm ~ 254 bpm
Optical sensor[see note 5]
Red light
Wavelength: about 660 nm, optical output power: < 6.65 mW
Infrared light
Wavelength: about 905 nm, optical output power: < 6.75 mW
Memory
Up to 99 group of data under auto mode, total duration does not exceed 72 hours.
Up to 24-hour data under manual mode.
Safety class
ClassⅡ, type BF applied part
International Protection
IP22
Alternating current supply
DC 3.6 V ~ 4.2 V
Working current
≤0.84VA
Power supply
A rechargeable lithium battery (3.7 V) (The red wire on the battery denotes anode, the black wire
on the battery denotes cathode.)
Battery life
Charge and discharge: no less than 500 times.
Adapter specification
Output voltage: DC 5V
Output current: 1000 mA
Dimension and Weight
Dimension
159(L) × 72(W) × 31(H) mm
Weight
About 250 g (with a lithium battery)
Note 1: the claims of SpO
2
accuracy shall be supported by clinical study measurements taken over the full range. By artificial
inducing, get the stable oxygen level to the range of 70 % to 100 % SpO
2
, compare the SpO
2
values collected by the secondary
standard pulse oximeter equipment and the tested equipment at the same time, to form paired data, which are used for the accuracy
analysis.(It is applicable for the probes equipped.)
There are 12 healthy volunteers (male: 6. female: 6; age: 18~50; skin color: black: 2, light: 8, white: 2) data in the clinical report.
Note 2: because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of pulse oximeter
equipment measurements can be expected to fall within ±Arms of the value measured by a CO-OXIMETER.
Note 3: Patient simulator has been used to verify the pulse rate accuracy, it is stated as the root-mean-square difference between the
PR measurement value and the value set by simulator.
Note 4: percentage modulation of infrared signal as the indication of pulsating signal strength, patient simulator has been used to
verify its accuracy under conditions of low perfusion. SpO
2
and PR values are different due to low signal conditions, compare them
with the known SpO
2
and PR values of input signal.
Note 5: optical sensors as the light-emitting components, will affect other medical devices applied the wavelength range. The
information may be useful for the clinicians who carry out the optical treatment.For example, photodynamic therapy operated by
clinician.
10 Factory Default
default
unit
Bluetooth (selection function)
off
Pulse Sound
on
Mode(display mode)
Limit
Wave
on
Brightness
4
Language
EN
Alarm Volume
3
SpO
2
alarm high limit
100
%
SpO
2
alarm low limit
85
%
Pulse rate alarm high limit
120
bpm
Pulse rate alarm low limit
30
bpm
alarm volume
3
Password
7762
SpO
2
alarm
on
PR alarm
on
Mode(record mode)
Manual
Attached List
State
Alarm condition delay
Alarm signal generation delay
Low voltage alarm
1s
20ms
SpO
2
alarm
330ms
20ms
Pulse rate alarm
330ms
20ms
Probe error alarm
16ms
20ms
EMC
Table 1:
Guidance and manufacturer’s declaration –electromagnetic emission
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The purchaser or the patient of the device
should assure that it is used in such environment.
Emission test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Applicable
Table 2:
Guidance and manufacturer’s declaration-electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The purchaser or the patient of the Pulse
Oximeter should assure that it is used in such environment.
Immunity test
IEC60601 test level
Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
±8 kV contact
± 15kV air
±8 kV contact
±15kV air
Electrical fast transient/burst
IEC 61000-4-4
±2kV for power supply lines
±1kV for input/output line
±2kV for power supply lines
Not Applicable
Surge
IEC 61000-4-5
±1kV lines to lines
±2kV lines to earth
±1kV lines to lines
Not Applicable
Voltage dips, short interruptions and voltage
vatiations on power supply input 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 sec
<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 sec
Power frequency (50 / 60Hz)
magnetic field IEC 61000-4-8
30 A/m
30A/m
Table 3:
Guidance and manufacturer’s declaration – electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer the patient of the Pulse
Oximeter should assure that it is used in such environment.
Immunity test
IEC 60601 test level
Compliance level
Conducted RF
IEC61000-4-6
3 V
0,15 MHz – 80 MHz
6 V in ISM bands between
0,15 MHz and 80 MHz
3 V
0,15 MHz – 80 MHz
6 V in ISM bands between
0,15 MHz and 80 MHz
Radiated RF
IEC61000-4-3
10 V/m 80 MHz- 2.7 GHz
10 V/m80 MHz- 2.7 GHz
NOTE 1 At 80 MHz and 800 MHz, 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.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast 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 Pulse Oximeter is used exceeds the applicable RF compliance level above, the Pulse
Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Pulse Oximeter.
Table 4：
Guidance and manufacturer’s declaration - electromagnetic Immunity
The [Code SI] is intended for use in the electromagnetic environment specified below. The customer or the patient of the Pulse
Oximeter should assure that it is used in such an environment
Radiated RF
IEC61000-4-3
(Test specifications
for ENCLOSURE
PORT IMMUNITY
to RF wireless
communications
equipment)
Test
Frequency
(MHz)
Band a)
(MHz)
Service a)
Modulation b)
Modulation b)
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
385
380
–390
TETRA 400
Pulse
modulation b)
18 Hz
1,8
0,3
27
450
380
–390
GMRS 460,
FRS 460
FM c)
± 5 kHz
deviation
1 kHz sine
2
0,3
28
710
704
–787
LTE Band
13,17
Pulse
modulation b)
217 Hz
0,2
0,3
9
745
780
810
800
–960
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz
2
0,3
28
870
930
1720
1700
–1990
GSM 1800;
CDMA
1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4, 25;
UMTS
Pulse
modulation b)
217 Hz
2
0,3
28
1845
1970
2450
2400
–2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz
2
0,3
28
5240
5100
–5800
WLAN
802.11
a/n
Pulse
modulation b)
217 Hz
0,2
0,3
9
5500
5785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME
EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual
modulation, it would be worst case.
The MANUFACTURER should consider reducing the minimum separation distance, based on
RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation
distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation:
P
d
6
E 
Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in V/m.
Warning
1)
Don’t near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance
imaging, where the intensity of EM DISTURBANCES is high.
2) 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.
3)
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.”
4) 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 the
device including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
5) Active medical devices are subject to special EMC precautions and they must be installed and used in accordance with
these guidelines.
Note：
 When the device is disturbed, the data measured may fluctuate, please measure repeatedly
or in another environment to
ensure its accuracy.
Bluetooth (selection function) Specification
Working frequency: 2402 MHz ~ 2480 MHz
Modulation mode: GFSK
Transmitting power: -6
dBm, +4 dBm