7. Equipment Response Time
As shown in the following figure. Response of slower average is 8s.
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 part of the device);
According to the degree of protection against ingress of water: IP22
According to the mode of operation: CONTINUOUS OPERATION
Clinical Study Summary
The following details are provided to disclose actual performance observed in the clinical validation study of healthy adult
volunteers. The ARMS value analysis statement and Bland-Altman plot of data is shown as following:
ARMS Value Analysis Statement
Bland-Altman Plot Graphic
Declaration
Guidance and Manufacturer’s declaration – electromagnetic emissions-For all EQUIPMENT and SYSTEMS
Guidance and Manufacturer’s declaration - electromagnetic emission
The 500CL Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of
500CL Pulse Oximeter should assure that it is used in such an environment.
Electromagnetic Environment – guidance
The 500CL 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
The pulse Oximeter (500CL) 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
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Guidance and Manufacturer’s declaration – electromagnetic immunity-For all EQUIPMENT and SYSTEMS
Guidance and Manufacturer’s declaration - electromagnetic immunity
The 500CL Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of
the 500CL Pulse Oximeter should assure that it is used in such an environment.
Electromagnetic Environment – guidance
Discharge (ESD)
+/- 8kV air
+/- 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
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 500CL Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of
the 500CL Pulse Oximeter should assure that it is used in such an environment.
Electromagnetic Environment – guidance
Radiated
RF
IEC
61000-4-3
3 V/m
2.5 GHz
3 V/m
Portable and mobile RF communications equipment should be used no closer
to any part of the Pulse Oximeter (500CL), 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 Pulse Oximeter (500CL) should be observed to verify normal operation. If
abnormal performance is observed, additional measurements may be necessary, such as reorienting of the relocating the Pulse
Oximeter (500CL).
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 (500CL)
The Pulse Oximeter (500CL) is intended for use in electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Pulse Oximeter (500CL) can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulse
Oximeter (500CL) as recommended below, according to the maximum output power of the communications equipment.
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
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
The oximeter fails to
display
SpO
2
and/or
1. Finger is not inserted correctly
2. User’s blood flow is too low to be measured
1. Make sure that the finger is placed right in
between the sensor and LED lights
2. Make sure th
at nothing is hindering the user’s
blood flow
2
or PR changes
1. Finger might not be inserted deep enough
2. Excessive body movement
1. Insert the finger deep into the chamber
2. Please do not move during measurement
The oximeter cannot
be powered on
2. Batteries might be installed incorrectly
3. The oximeter might be damaged or defective
1. Please replace the batteries
2. Please refer to ‘Battery Installation’ instruc
3. Please contact local customer service center
turns off suddenly
1. The oximeter automatically powers off when no signal
is detected for more than 8 seconds
2. The batteries are drained
1. This is normal. Just turn the oximeter on
again.
If Err code is displayed on the screen, please contact local customer service center.
Symbol Definitions
Symbol Definition Symbol Definition
Type BF applied part
Attention
IP22
Protected against dripping water
Waste electrical and electronic equipment
No SpO
2
Alarm
Follow instruction for use
Symbol of oxygen saturation
Symbol of pulse rate
Storage temperature and relative
humidity
Applicable Models
500CL
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.
Manufactured for:
Einstein Associates LLC
10101 Stafford Centre Drive Suite B
Stafford TX 77477
ALL RIGHTS RESERVED
Issued Date: Jan 2020
To Previous Page
Loading...
