Eocene EOC-SPOBT-L User manual

Eocene Pulse Oximeter EOC - SPOBT-L
In clinical trials, the Eocene ngertip pulse oximeter has proved to measure oxygen
saturation in blood accurately. When the nger is inserted, a light sensitive probe
measures the data and displays on the screen
Measurement Principle
Pulse oximeters measure how much of the hemoglobin in blood is carrying oxygen
(oxygen saturation).
The principle of pulse oximetry is based on the red and infrared light absorption charac-
teristics of oxygenated and deoxygenated hemoglobin. Oxygenated hemoglobin absorbs
more infrared light and allows more red light to pass through. Deoxygenated (or reduced)
hemoglobin absorbs more red light and allows more infrared light to pass through. Red
light is in the 600-750 nm wavelength light band. Infrared light is in the 850-1000 nm
wavelength light band.
Eocene Pulse oximeter uses a light emitter with red and infrared
LEDs that passes through a nger. A photodetector below the
nger receives the light. A part of the light is absorbed by the nger
and the balance light is received by the detector. The amount of
light that is absorbed by the nger depends on many physical
properties and these properties are used by the pulse oximeter to
calculate the oxygen saturation.
Display Type: LED display
SpO2: Measurement range::35-99%
Accuracy:±2% on the stage of 80%-99%; ±3% on the stage of 70%-80%;Pulse Rate:
Measure range:30-235 BPM
Accuracy:±2 BPM or ±2%(larger)
Pulse Intensity: Bargraph IndicatorPower Requirements: Two AAA alkaline Batteries
Power consumption: Less than 40mA
Low power indication:
Battery Life: Two AAA 1.5V, 600mAh alkaline batteries could be continuously operated
as long as 30 hours.
Environment Requirements:
Operation Temperature: 5-40℃
Storage Temperature: -10-40℃
Ambient Temperature: 15%-80% in operation; 10%-80% in storage
Declaration: EMC of this product comply with IEC60601-1-2 standard.
Measurement Performance in Low Perfusion Condition: required the test equipment
(BIO-TEK INDEX Pulse Oximeter tester) the pulse wave is available without failure when
the simulation pulse wave amplitude is at 6%.
Interference Resistance Capacity against Ambient Light: Device work normally when
mixed noise produced by BIO-TEK INDEX Pulse Oximeter tester
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Technical Specications
What is in the Box
Pulse Oximeter
Hang lace
Batteries
warranty card
Precautions and Safety information
Do not use the pulse oximeter in an MRI or CT environment
Do not use the pulse oximeter in situations where alarms are required. The device has
no alarms.
Explosion hazard: Do not use the pulse oximeter in an explosive atmosphere.
The pulse oximeter is intended only as an adjunct in patient assessment. It must be
used in conjunction with other methods of assessing clinical signs and symptoms.
Check the pulse oximeter sensor application site frequently to determine the position-
ing of the sensor and circulation and skin sensitivity of the patient.
Do not stretch the adhesive tape while applying the pulse oximeter sensor. This
may cause inaccurate readings or skin blisters.
Read this manual completely before using the oximeter
The pulse oximeter has no SpO2 alarms; it is not for continuous monitoring, as indicated
by the symbol.
Prolonged use or the patient’s condition may require changing the sensor
site periodically. Change sensor site and check skin integrity, circulatory status, and
correct alignment at least every 4 hours.
Inaccurate measurements may be caused by autoclaving, ethylene oxide sterilizing, or
immersing the sensors in liquid, signicant levels of dysfunctional hemoglobins
(such as carbonxy- hemoglobin or methemoglobin), intravascular dyes such as
indocyanine green or methylene blue
SpO2 measurements may be adversely aected:
Follow local ordinances and recycling instructions regarding disposal or recycling of
the device and device components, including batteries.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
In the presence of high ambient light. (Shield the sensor area with a surgical
towel) or exposure to direct sunlight
If excessive movement is made by the user while measuring or has venous
pulsations
If the device is placed near a blood pressure cu, arterial catheter, or
intravascular line
If the user has hypotension, severe vasoconstriction, severe anemia, or
hypothermia
If user is in cardiac arrest or is in shock
If the user has Fingernail polish or false ngernails
A.
B.
C.
D.
E.
F.
Battery Installation
Press on the cover of the battery compartment and slide it
down. insert the 2 ‘AAA’ Batteries by matching the polari-
ties: + (positive) and - (Negative) as marked in the battery
compartment. Slide in the cover back.
: 1
: 1
: 2 AAA batteries
: 1
Bluetooth enabled, receive readings on
mobile devices
small in volume,
light in weight (total weight is about 50g
including batteries and convenient to carry.
Low power consumption,
Battery low indicator
Auto power-o in 8 seconds when idle.
Features
1.
2.
3.
4.
5.
6.
Hang lace Installation
Thread thinner end of the hang lace through the hanging hole
Thread thicker end of the lace through the threaded end and pull it tightly
Declaration
EMC of this product comply with IEC60601-1-2 standard. The materials that comes in contact
with the user have no toxicity and no action on issues; comply with ISO10993-1,-5,-10.

Maintenance & Storage
Replace the batteries promptly when low voltage lamp is lighted
Clean surface of the oximeter before it is used in diagnosis for patients
Remove the batteries from the battery compartment when the oximeter is stored for a
long duration.
It is best to store the product in a place where ambient temperatures is –10C to
40C (14F -104F) and humidity is 10%-80%
Store the oximeter in a dry environment anytime. A wet ambient might aect its
lifetime and even might damage the product.
1.
2.
3.
4.
5.
Calibrating the Pulse Oximeter
The functional tester cannot be used to assess the accuracy of the Oximeter.
The test methods used to establish the SpO2 accuracy is clinical testing.
The oximeter used to measure the arterial hemoglobin oxygen saturation levels and these
levels are to be compared to the levels determined from arterial blood sampling with a
CO-Oximeter.
Guidance and Manufacturer’s declaration - Electromagnetic Emission
The pulse Oximeter is intended for use in the electromagnetic environment specied
below. The user of the Oximeter should ensure that it is used as specied below.
Emission Test Compliance
Electromagnetic Environment - Guidance
RF Emissions
CISPR 11 Group 1
The Pulse Oximeter uses RF energy for it’s internal
function only. Therefore, RF emissions from the
device is very low and are not likely to cause any
interference to other nearby equipment
RF Emissions
CISPR 11 Class B
The Pulse Oximeter is suitable for use in all
establishments, including domestic and those
directly connected to the public low-voltage power
supply networks that supply power to buildings
used for domestic purposes.
Possible Problems and Resolutions
Problem Possible Reason Solution
SpO2 or PR is not
appearing
Finger is not inserted
correctly
Oxy-hemoglobin is too
low to measure
Retry by inserting nger correctly
Try a few more times. If no display, please go to
a hospital or clinic immediately
SpO2 or PR is
unstable
Finger is not inserted
deep enough
Finger is shaking or user’s
body is moving
Retry by inserting nger deep enough
Try to stay still and measure again
The Oximeter is not
powering on
Battery must be
depleted or not present
Battery must be inserted
incorrectly
Please replace or insert new batteries
Insert batteries with polarities matching the
image shown in the battery compartment
The device may be
damaged Please contact Customer Service
The indicator lamp
went o suddenly
Battery must be
depleted or not present
This is normal
Insert new Alkaline batteries
The device powers o
automatically when no
signal is detected for 8
seconds
“Error3”or“Error4”
displayed
Low Power
Receiving tube is
shielded or damaged or
connecter broken
Amp circuit malfunction
Insert new Alkaline batteries
Please contact Customer Support
“Error7”
displayed Current control circuit
malfunction
Insert new Alkaline batteries
Please contact Customer Support
Emission tube damaged
Low Power
One year warranty from the date of purchase. Purchase invoice required. Warranty service shall not be
provided if the device malfunction is because:
1. The user opened the device and or dismantled and reinstalled the device
2. User inadvertently or otherwise dropped the device
3. lack of reasonable maintenance
4. User operated the device not in accordance with the guidelines provided in the user manual
5. Repair or maintenance done by an unauthorized personnel or establishment
Service provided outside the scope of warranty will be charged as per prevailing regulations and
stipulated rates. For warranty services and Customer Support please contact:
Eocene Systems,
2441 Bellevue Avenue,
Daytona Beach, FL 32114
Support: 321-567-0688 FAX: 321-567-0688
Warranty
SpO2
Symbol Denition
The equipment type is BF Refer to User guide before application
Hemoglobin saturation; Heart rate BPM Low Power indication
Model Number:
Date of Purchase:
Name of Store
Address:
Zip:
Name of Purchaser:
Address:
Zip:
Phone:
Warranty Card
Please attached copy of purchase invoice
State:
State: