CONTEC MEDICAL SYSTEMS CMS50S Руководство пользователя - Страница 2
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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
LED
Flicker
Status
Status meaning
color
frequency
Yellow
Light always
Charging.
Charge
Green
Light always
Charging completed.
Transmitting, flicker frequency
Blue
Flicker
Bluetooth
automatically changes with data rate.
connection
Blue
Light always
Bluetooth has been connected.
It displays green after power on, which
Green
Light always
indicates that there is no memory and
power, etc.
The valid SpO
data is detected, start
2
Non-charging,
Green
Flicker
recording and flicker 3 times, then the
non-memory,
LED is off.
non-Bluetooth
Memory space is not enough to store 8
connection
Yellow
Flicker
hours.
Red
Light always
Probe fault.
Battery power is not enough to test 8
Red
Flicker
hours.
Flicker 3
Memory full, enter standby mode after
Yellow
times
flickering 3 times.
Memory
Flicker 3
Low power, enter standby mode after
Red
times
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
1) The finger is not properly
1) Please insert the finger
inserted.
properly and measure
2) The finger is shaking or the
again.
The finger can
not be
user is moving.
2) Let the user keep calm.
recognized.
3) The device is not used in
3) Please use the device in
correctly.
environment required by the
normal environment.
manual.
4) Please contact the
4) The device works abnormally.
after-sales.
Low battery or the battery is
Please charge the battery.
The device can
Please contact the
drained away.
not be turned on.
The device works abnormally.
after-sales.
The device can
Please charge the battery.
not be used for
The battery is not charged fully.
Please contact the
full time after
The device works abnormally.
after-sales.
charge.
The battery can
not be fully
Please contact the
charged even
The device works abnormally.
after-sales.
after 10-hour
charging time.
Please operate the device
The device is not operated
The data can not
according to the manual.
according to the manual.
be stored.
Please contact the
The device works abnormally.
after-sales.
8 Key of Symbols
Symbols
Meaning
Symbols
Meaning
Refer to instruction
Type BF applied part
manual/booklet
No alarm
Bluetooth icon
International
IP22
Recyclable
Protection
Battery anode
Battery cathode
Manufacturer
Use-by date
Temperature
Humidity limitation.
limitation.
Atmospheric
This way up.
pressure limitation.
Fragile, handle with
Keep away from rain.
care.
Serial number
Exit/enter standby mode
Sensor
The probe is
Sensor
Probe failure
Off
disconnected.
Fault
Date of manufacture
WEEE (2012/19/EU)
P/N
Material code
LOT
Batch No.
PRbpm
Pulse rate (bpm)
%SpO
Pulse oxygen saturation (%)
2
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
[see note 1]
2
Displayed range
0%~99% (work with Smart Device Assistant)
Measured range
0%~100%
70% ~ 00%: ±2%;
Accuracy[see note 2]
0% ~ 69%: unspecified.
Resolution
1%
PR
30 bpm ~ 250 bpm
Displayed range
(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 0.4%:
Low perfusion[see note 4]
SpO
: ±4%;
2
PR: ±2 bpm or ±2%, whichever is greater
Compared the value measured in room light and
Light interference
existing lighting with the value measured under
darkroom conditions, deviation: ≤ 1%
Optical sensor[see note 5]
Wavelength: about 660 nm, optical output power:
Red light
<6.65 mW
Wavelength: about 905 nm, optical output power:
Infrared light
<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
≤100 mA
Working current
A rechargeable lithium battery (3.7V) (The red wire
Power supply
on the battery denotes anode, the black wire on the
battery denotes cathode.)
Battery working life
Charge and discharge: no less than 500 times.
Output voltage: DC 5V
Adapter specification
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
accuracy shall be supported by clinical study measurements
2
taken over the full range. By artificial inducing, get the stable oxygen level to the range
of 70 % to 100 % SpO
, compare the SpO
values collected by the secondary standard
2
2
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
and PR values are different due to low signal conditions, compare them
2
with the known SpO
and PR values of input signal.
2
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)
±8kV contact
±8kV contact
IEC 61000-4-2
± 15 kV air
±15kV air
Power frequency (50 / 60Hz)
magnetic field
30 A/m
30A/m
IEC 61000-4-8
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
10 V/m 80 MHz- 2.7 GHz
10 V/m80 MHz- 2.7 GHz
IEC61000-4-3
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
Mod
Test
Band
ulati
Distan
Freque
Modulati
a)
Service a)
on
ce
ncy
on b)
(MHz)
b)
(m)
(MHz)
(W)
Pulse
380
modulatio
385
TETRA 400
1,8
0,3
–390
n b)
18 Hz
FM c)
± 5 kHz
380
GMRS 460,
450
deviation
2
0,3
–390
FRS 460
1 kHz
sine
Radiated
710
Pulse
RF
modulatio
IEC6100
704
LTE Band
0,2
745
n b)
0,3
0-4-3
–787
13,17
217 Hz
(Test
specifica
780
tions for
GSM
ENCLO
800/900,
Pulse
SURE
TETRA 800,
modulatio
810
PORT
iDEN 820,
n b)
800
2
0,3
–960
IMMUN
CDMA 850,
18 Hz
ITY to
LTE Band 5
RF
870
wireless
930
communi
1720
GSM 1800;
cations
1845
CDMA
equipme
1900;
Pulse
1700
nt)
GSM 1900;
modulatio
2
0,3
DECT;
n b)
–1990
1970
LTE Band 1,
217 Hz
3,
4, 25; UMTS
Bluetooth,
Pulse
WLAN,
2400
modulatio
2450
802.11 b/g/n,
2
0,3
–2570
n b)
RFID 2450,
217 Hz
LTE Band 7
5240
Pulse
WLAN
5100
modulatio
5500
802.11
0,2
0,3
–5800
n b)
a/n
5785
217 Hz
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
6
E
following equation:
P
d
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
Don't near active HF SURGICAL EQUIPMENT and the RF shielded room of an
A.
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
IMMUNIT
Y
TEST
LEVEL
(V/m)
27
28
9
28
28
28
9