User manual

As shown in the right figure.
Response time of slower average is 12.4s.
9. Interference Resistance Capacity against Ambient Light
Device works normally when mixed noise produced by BIO-TEK INDEX Pulse Oximeter Tester.
10. Classification
According to the type of protection against electric shock: INTERNALLY POWERED EQUIPMENT;
According to the degree of protection against electric shock: TYPE BF APPLIED PART;
According to the method(s) of sterilization or disinfection recommended by the manufacturer: Equipment with method(s) of
sterilization or disinfection recommended by the manufacturer;
According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH
OXYGEN OR NITROUS OXIDE: EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE.
According to the degree of protection against ingress of water: IPX1
According to the mode of operation: CONTINUOUS OPERATION
Declaration
Guidance and Manufacturer’s declaration – electromagnetic emissions-For all EQUIPMENT and SYSTEMS
1 Guidance and Manufacturer’s declaration - electromagnetic emission
2
The SM-230/SM-240 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
customer or the user of SM-230/SM-240 Pulse Oximeter should assure that it is used in such an environment.
3
Emission test Compliance Electromagnetic Environment – guidance
4
RF emissions CISPR 11 Group 1
The SM-230/SM-240 Pulse Oximeter 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.
5
RF emissions CISPR 11
Class B
6
Harmonic emissions IEC 61000-3-2
N/A
7
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
N/A
Guidance and Manufacturer’s declaration – electromagnetic immunity-For all EQUIPMENT and SYSTEMS
Guidance and Manufacturer’s declaration - electromagnetic immunity
The SM-230/SM-240 Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The customer or the user of the SM-230/SM-240 Pulse Oximeter should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Compliance
Level
Electromagnetic Environment – guidance
Electrostatic Discharge
(ESD) IEC 61000-4-2
+/- 6kV contact
+/- 8kV air
+/- 6kV contact
+/- 8kV air
Floors should be wood, concrete or ceramic tile. If
floor are covered with synthetic material, the relative
humidity should be at least 30%.
Electrostatic transient /
burst IEC 61000-4-4
±2kV for power supply
lines
±1kV for input/output
lines
N/A
Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5
± 1 kV differential mode
± 2 kV common mode
N/A
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations 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 cycles
70 % UT (30 % dip in
UT) for 25 cycles
< 5 % UT (>95 % dip in
UT) for 5 sec
N/A
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the SM-230/SM-240 Pulse Oximeter requires
continued operation during power mains
interruptions, it is recommended that the
SM-230/SM-240 Pulse Oximeter be powered from
an uninterruptible power supply or a battery.
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
3A/m 3A/m
Power frequency magnetic fields should be at levels
characteristics 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 –
For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and Manufacturer’s declaration - electromagnetic immunity
The SM-230/SM-240 Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The customer or the user of the SM-230/SM-240 Pulse Oximeter should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
Level
Electromagnetic Environment – guidance
Conducted
RF IEC
61000-4-6
Radiated
RF IEC
61000-4-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
N/A
3 V/m
Portable and mobile RF communications equipment should be used no closer to
any part of the SM-230/SM-240 Pulse Oximeter, including cables, than the
recommended separation distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
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
a
, should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with following
symbol:
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
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 SM-230/SM-240 Pulse Oximeter is used exceeds the applicable RF
compliance level above, the SM-230/SM-240 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 SM-230/SM-240 Pulse
Oximeter.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
Recommended separation distances between portable and mobile RF communications equipment and
the EQUIPMENT or SYSTEMS - For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment and the MD300C63 Pulse Oximeter
The SM-230/SM-240 Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the SM-230/SM-240 Pulse Oximeter can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
SM-230/SM-240 Pulse Oximeter as recommended below, according to the maximum output power of the communications
equipment
Separation distance according to frequency of transmitter (m)
Rated maximum output of
transmitter (W)
150 kHz to 80 MHz
80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 / 0.12 0.23
0.1 / 0.38 0.73
1 / 1.2 2.3
10 / 3.8 7.3
100 / 12 23
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 80 MHz and 800 MHz, 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.
Possible Problems and Solutions
Problems Possible reason Solution
SpO
2
or PR can not
be shown normally
1. Finger is not inserted correctly
2. Patient’s SpO
2
value is too low to be measured
1. Retry by inserting the finger
2. There is excessive illumination
3. Try some more times. If you can make sure no
problem is existing in the product, please go
to a hospital timely for exact diagnosis.
SpO
2
or PR is shown
unstably
1. Finger might not be inserted deep enough.
2. Excessive patient movement
1. Retry by inserting the finger
2. Be calmness
The oximeter can not
be powered on
1. No battery or low power of battery
2. Batteries might be installed incorrectly
3. The oximeter might be damaged
1. Please replace batteries
2. Please reinstall the batteries
3. Please contact with local customer service
centre
Indication lamps are
suddenly off
1. The product is automatically powered off when no
signal is detected longer than 8 seconds
2. The battery power is too low to work
1. Normal
2. Replace the batteries
“Error3” or
“Error4” is displayed
on screen
1. Err 3 means the red emission LED is damaged
2. Err 4 means the infra-red emission LED is damaged
1. Check the red emission LED
2. Check the infra-red emission LED
Error 6
Err 6 means the screen is failure Change the screen
“Error7” is displayed
on screen
Err 7 means all the emission LED or reception dioxide is
damaged.
Check the emission LED and reception dioxide.
Symbol Definitions
Symbol Definition Symbol Definition Symbol Definition
Type BF applied
part.
No SpO
2
Alarm
Date of Manufacture
Attention, consult
accompanying
documents.
SN
Serial No.
PR bpm
Pulse rate (BPM)
Protected against
dripping water.
Storage temperature and
relative humidity
﹪SpO
2
Oxygen saturation
Low power
indication
Note: The illustrations used in this manual may differ slightly from the appearance of the actual product.
Manufactured for：IRoams Network
Address：713 W. Duarte Rd #G810
Arcadia, CA 91007 USA
ALL RIGHTS RESERVED
Issue Date: 23/September 2011