8. 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, (applied part: the rubber hole of the device);
According to the degree of protection against ingress of water: IP22
According to the mode of operation: CONTINUOUS OPERATION
FCC Declaration
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference.
(2) This device must accept any interference received, including interference that may cause undesired operation.
Please take attention that changes or modification not expressly approved by the party responsible for compliance could void the
user’s authority to operate the equipment.
Note: This product has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC
Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This
product generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a
particular installation. If this product does cause harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
—Consult the dealer or an experienced radio/TV technician for help.
Declaration
Guidance and Manufacturer’s declaration – electromagnetic emissions-
For all EQUIPMENT and SYSTEMS
Guidance and Manufacturer’s declaration - electromagnetic emission
The Wireless fingertip Pulse Oximeter OX200 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Wireless fingertip Pulse Oximeter OX200 should assure that it is used in such an environment.
Emission test Compliance Electromagnetic Environment – guidance
RF emissions CISPR 11 Group 1 The Wireless fingertip Pulse Oximeter OX200 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 The Wireless fingertip Pulse Oximeter OX200 is suitable for
use in all establishments, including domestic establishments
and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
Harmonic emissions IEC 61000-3-2 Not Applicable
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Not Applicable
Guidance and Manufacturer’s declaration – electromagnetic immunity-
For all EQUIPMENT and SYSTEMS
Guidance and Manufacturer’s declaration - electromagnetic immunity
The Wireless fingertip Pulse Oximeter OX200 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Wireless fingertip Pulse Oximeter OX200 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%.
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.
Guidance and Manufacturer’s declaration – electromagnetic immunity-
For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and Manufacturer’s declaration - electromagnetic immunity
The Wireless fingertip Pulse Oximeter OX200 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Wireless fingertip Pulse Oximeter OX200 should assure that it is used in such an environment.
Immunity
test
IEC 60601 test
level
Compliance
Level
Electromagnetic Environment – guidance
Radiated
RF
IEC
61000-4-3
3 V/m
80 MHz to 2.5
GHz
3 V/m
Portable and mobile RF communications equipment should be
used no closer to any part of the Wireless fingertip Pulse
Oximeter OX200, 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 station 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 Wireless fingertip Pulse Oximeter OX200 should be observed to verify
normal operation. If abnormal performance is observed, additional measurements may be necessary, such as reorienting of the
relocating the Wireless fingertip Pulse Oximeter OX200.
b Over the frequency range 150 kHz to 80 MHz, fields strengths should be less than 3 V/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 Pulse Oximeter ( OX200)
The Wireless fingertip Pulse Oximeter OX200 is intended for use in electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Wireless fingertip Pulse Oximeter OX200 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Wireless fingertip Pulse Oximeter OX200 as recommended below, according to the maximum output
power of the communications equipment.
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of transmitter (m)
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01 0.1167 0.2334
0.1 0.3689 0.7378
1 1.1667 2.3334
10 3.6893 7.3786
100 11.6667 23.3334
For transmitters rated at a maximum output power not listed above, the recommended separation distanced 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 Oxyhemoglobin value is too low to be
measured
1.Retry by inserting the finge
2. Try some more times. If you can make sure no
problem exist 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. Finger is trembling or patient’s body is in movement
status.
1. Retry by inserting the finge
2. Try not to move
The oximeter can not
be powered on
1. Power of batteries might be inadequate or not be
there at all.
2. The oximeter might be damaged.
1. Please charge batte
y
2. 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. Power quantity of the batteries is started being
inadequate
1. Normal
2. Please charge battery
“Error3”
1. Low power
2. Receiving tube being shielded or damaged together
with broken connector.
3. Mechanical Misplace for receive-emission tube.
4. Amp circuit malfunctions.
1. Please cha
ge battery
2. Please contact local customer service center
3. Please contact local customer service center
4. Please contact local customer service center
“Error7” is displayed
on screen
1. Low power
2. Emission tube damaged.
3. Current control circuit malfunctions.
1. Please cha
ge battery
2. Please contact local customer service center
3. Please contact local customer service center
Symbol Definitions
Symbol Definition
Type BF applied part.
Attention.
Follow instruction for use
IP22
Degrees of protection provided by enclosure.
﹪SpO
2
Oxygen saturation
Pulse rate (BPM)
The battery icon flash means power low
SN
Serial No.
?
The signal inadequacy indicator
Bluetooth indicator
The waste electrical and electronic equipment
Storage temperature and relative humidity
Manufacturer’s information
Date of Manufacture
European union approval
Box Contents
1. The wireless fingertip pulse oximeter OX200
2. USB charge cable
3. One user’s manual
Applicable Models
OX210
Notes:
1. The illustrations used in this manual may differ slightly from the appearance of the actual product.
2. The specifications are subject to change without prior notice.
3. To obtain the more information about the App, please visit the http:// www. ichoicelife.com
ALL RIGHTS RESERVED
Version: Ver1.0
Revised Date: February 13, 2019
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