User Manual

5.4 Data storage
a. After inserting the finger, the device recognizes the data and starts storing
automatically; it will close storage automatically after pulling out the finger.
b. From the time for the first open of the storage, the data within 48h can be
automatically spliced into one segment of data.
c. After 48 hours, the device can not store the data.
5.5 Data upload
A. When no finger inserted, the bluetooth of the device is open, then the master
device can be connected with the device by Bluetooth.
B. The master device can realize such functions as time synchronization, data upload,
data delete, etc.
C. When the device is connected by Bluetooth, there is a blue LED for indicating,
refer to 5. for LED state.
5.6 Charging
A. Power adapter can be selected to charge for the device.
B. Under charging state, it indicates that the device is charging when the indicator is
yellow, it is fully charged when it is green.
5.7 Description for device state
Status
LED
color
Flicker
frequency
Status meaning
Charge
Yellow
Light always
Charging.
Green
Light always
Charging completed.
Bluetooth
connection
Blue
Flicker
Transmitting, flicker frequency
automatically changes with data rate.
Blue
Light always
Bluetooth has been connected.
Non-charging,
non-memory,
non-Bluetooth
connection
Green
Light always
It displays green after power on, which
indicates that there is no memory and
power, etc.
Green
Flicker
The valid SpO
2
data is detected, start
recording and flicker 3 times, then the
LED is off.
Yellow
Flicker
Memory space is not enough to store 8
hours.
Red
Light always
Probe fault.
Red
Flicker
Battery power is not enough to test 8
hours.
Memory
Yellow
Flicker 3
times
Memory full, enter standby mode after
flickering 3 times.
Red
Flicker 3
times
Low power, enter standby mode after
flickering 3 times.
Red
Light always
Probe fault.
6 Maintain, Transport and Storage
6.1 Cleaning and disinfection
The device must enter to the standby mode before cleaning, and it should not be
immersed into the liquid. Use 75% alcohol to wipe the device for disinfecting, 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 user’s 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 finger can
not be
recognized.
correctly.
1) The finger is not properly
inserted.
2) The finger is shaking or the
user 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 user keep calm.
3) Please use the device in
normal environment.
4) Please contact the
after-sales.
The device can
not be turned on.
Low battery or the battery is
drained away.
The device works abnormally.
Please charge the battery.
Please contact the
after-sales.
The device can
not be used for
full time after
charge.
The battery is not charged fully.
The device works abnormally.
Please charge the battery.
Please contact the
after-sales.
The battery can
not be fully
charged even
after 10-hour
charging time.
The device works abnormally.
Please contact the
after-sales.
The data can not
be stored.
The device is not operated
according to the manual.
The device works abnormally.
Please operate the device
according to the manual.
Please contact the
after-sales.
8 Key of Symbols
Symbols
Meaning
Symbols
Meaning
Refer to instruction
manual/booklet
Type BF applied part
No alarm
Bluetooth icon
IP22
International
Protection
Recyclable
Battery anode
Battery cathode
Manufacturer
Use-by date
Temperature
limitation.
Humidity limitation.
Atmospheric
pressure limitation.
This way up.
Fragile, handle with
care.
Keep away from rain.
Serial number
Exit/enter standby mode
Sensor
Off
The probe is
disconnected.
Sensor
Fault
Probe failure
Date of manufacture
WEEE (2012/19/EU)
P/N
Material code
LOT
Batch No.
PRbpm
Pulse rate (bpm)
%SpO
2
Pulse oxygen saturation (%)
European
Representative
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]
Displayed range
0%~99% (work with Smart Device Assistant)
Measured range
0%~100%
Accuracy[see note 2]
70% ~ 00%: ±2%;
0% ~ 69%: unspecified.
Resolution
1%
PR
Displayed range
30 bpm ~ 250 bpm
(work with Smart Device Assistant)
Measured range
30 bpm ~ 250 bpm
Accuracy[see note 3]
±2 bpm or ±2%, whichever is greater
Resolution
1 bpm
Low perfusion[see note 4]
Low perfusion 0.4%:
SpO
2
: ±4%;
PR: ±2 bpm or ±2%, whichever is greater
Light interference
Compared the value measured in room light and
existing lighting with the value measured under
darkroom conditions, deviation: ≤ 1%
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
Store about 48-hour data
Safety classification
Internally powered equipment, type BF applied part
International Protection
IP22
Working voltage
DC 3.6 V ~ 4.2 V
Working current
≤100 mA
Power supply
A rechargeable lithium battery (3.7V) (The red wire
on the battery denotes anode, the black wire on the
battery denotes cathode.)
Battery working life
Charge and discharge: no less than 500 times.
Adapter specification
Output voltage: DC 5V
Output current: 1000 mA
Dimension and Weight
Dimension
46 mm(L) × 26 mm(W) × 11.5 mm(H)
Weight
About 22 g (including 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.
There are 12 healthy volunteers (male: 6. female: 6; age: 18~45; 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.
Appendix 1 EMC Guidance and Manufacturer Declaration
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 user 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
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 user 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
± 15 kV air
± 8 kV contact
±15kV air
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 user of the Pulse Oximeter should assure that it is used in such environment.
Immunity test
IEC 60601 test level
Compliance level
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 user of the Pulse Oximeter should assure that it is used in such an
environment
Radiated
RF
IEC6100
0-4-3
(Test
specifica
tions for
ENCLO
SURE
PORT
IMMUN
ITY to
RF
wireless
communi
cations
equipme
nt)
Test
Freque
ncy
(MHz)
Band
a)
(MHz)
Service a)
Modulati
on b)
Mod
ulati
on
b)
(W)
Distan
ce
(m)
IMMUNIT
Y
TEST
LEVEL
(V/m)
385
380
–390
TETRA 400
Pulse
modulatio
n 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
modulatio
n 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
modulatio
n 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
modulatio
n 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
modulatio
n b)
217 Hz
2
0,3
28
5240
5100
–5800
WLAN
802.11
a/n
Pulse
modulatio
n 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
A. 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.
B. 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.
C. 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.”
D. 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.
E. 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.
Bulethooth Specification
Working frequency: 2402 MHz ~ 2480 MHz
Modulation mode: GFSK
Transmitting power: 0 dBm, +4 dBm
Receiving sensitivity: -93 dBm