Evo Pulse One Operator's Manual

OPERATOR’S
MANUAL

VER2.0C201

FingertipPulse Oximeter

General Description

Oxygen Saturation is a percentage of Oxyhemoglobin (HbO

2

) capacity, compounded with
oxygen, by all combinative hemoglobin (Hb) capacity in blood. In other words, it is
consistency of Oxyhemoglobin in blood. It is a very important parameter for the Respiratory
circulation System. Many respiratory diseases can result in oxygen saturation being lowered
in human blood. Additionally, the following factors can reduce oxygen saturation: Automatic
regulation of organ dysfunction caused by Anesthesia, Intensive Postoperative Trauma,
injuries caused by some medical examinations. That situation might result in
light-headedness, asthenia, and vomiting. Therefore, it is very important to know the oxygen
saturation of a patient so that doctors can find problems in a timely manner.

The fingertip pulse Oximeter features small size, low power consumption, convenient
operation and portability. It is only necessary for a patient to put one of his fingers into the
fingertip photoelectric sensor for diagnosis, and a display screen will show oxygen saturation.
It has been proven in clinical experiments that it also features high precision and repeatability.

Measurement principle

Principle of the Oximeter is as follows: A mathematical formula is established making use of
Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive
hemoglobin(RHb) and Oxyhemoglobin (HbO

2

) in glow and near-infrared zones. Operation
principle of the instrument is Photoelectric Oxyhemoglobin Inspection Technology is adopted
in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams
of different wavelength of lights (660nm glow and 940nm near infrared light) can be focused
onto a human nail tip through a clamping finger-type sensor. A measured signal obtained by a
photosensitive element, will be shown on two groups of LEDs through process in electronic
circuits and microprocessor

shown on two groups of LEDs through electronic circuits and a

microprocessor.

Diagram of Operation Principle

1. Red and Infrared-ray Emission Tube

2. Red and Infrared-ray Receipt Tube

Precautions for use

1 Do not use the pulse Oximeter in an MRI or CT environment.
2 Do not use the pulse Oximeter in situations where alarms are required. The device has

no alarms.
3 Explosion hazard: Do not use the pulse Oximeter in an explosive atmosphere.
4 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.
5 Check the pulse Oximeter sensor application site frequently to determine the positioning

of the sensor, circulation, and skin sensitivity.
6 Do not stretch the adhesive tape while applying the pulse Oximeter sensor. This may

cause inaccurate readings or skin blisters.
7 Before use, carefully read the manual.
8 The pulse Oximeter has no SpO

2

alarms; it is not for continuous monitoring, as indicated

by the symbol.
9 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.
10 Inaccurate measurements may be caused by autoclaving, ethylene oxide sterilizing, or

immersing the sensors in liquid.
11 Significant levels of dysfunctional hemoglobins (such as carboxyhemoglobin or

methemoglobin) may cause inaccurate readings.
12 Intravascular dyes such as indocyanine gr een or m eth yl ene bl ue ma y cau se in accurat e

readings.
13 SpO

2

measurements may be adversely affected in the presence of bright light. Shield

the sensor area (with a towel, from direct sunlight, for example) if necessary.
14 Excessive patient movement may cause inaccurate readings.
15 High-frequency electrosurgical interference.
16 Venous pulsations may cause inaccurate readings.
17 Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or

intravascular line may cause inaccurate readings.
18 Hypotension, severe vasoconstriction, severe anemia, or hypothermia may cause

inaccurate readings.
19 Cardiac arrest or shock may cause inaccurate readings.
20 Fingernail polish or false fingernails may cause inaccurate SpO

2

readings.

Follow local ordinances and recycling instructions regarding disposal or recycling of
the device and device components, including batteries.

Product Properties

1 Operation of the product is simple and convenient.
2 The product is small in size, light in weight (total weight is about 50g including batteries).
3 Power consumption of the product is low and the two

originally-equipped, two AAA

batteries can be operated continuously for 30 hours.

4

A low voltage warning will be shown on the display when battery voltage is so low that

the Oximeter might not operate normally.

5 The product will automatically be powered off when no signal is detected for longer than

8 seconds.

Product Operation Scope

The fingertip Oximeter can be used to measure human Oxygen Saturation a nd heart rate
through the finger. The product is suitable for use in families, hospitals (including clinical use
in internist/surgery, anesthesia, pediatrics, intensive care etc.) Oxygen Clubs, social medical
organizations, and in sports (It can be used before or after sports. Operation during sports is
not recommended.).

The product is not suitable to monitor a patient continuously.

Operation Instructions

1 Install two AAA batteries into battery cassette before closing its cover.

Insert a finger into the rubber hole of the Oximeter, as shown in the diagram below. (It is

best to insert the finger as far as possible before releasing the clamp.)
2 Press the switch button once on front panel.
3 While using the Oximeter, your finger should not tremble and you should not move

around.
4 Read corresponding data on the display screen.
5 Two display modes.

After turning on the Oximeter, each time you press the power switch the Oximeter will
switch to another display mode. There are two display modes, shown as follows:

1 2

When you press the power switch for a long time (more than one second), the bright ness of
the Oximeter will be changed by degrees, there are 10 levels on brightness; the default l evel
is level four.

Note: Please use medical alcohol to clean the rubber, inside the Oximeter, that touches the
finger. Also, clean the test finger w i th alcohol before and after each test. (The rubber inside of
the Oximeter is medical rubber, which has no toxins, and is not harmful to the skin).

When your finger is inserted into the Oximeter, your nail surface must be upward.

Brief Description of Front Panel

The pulse rate bar graph display corresponds with pulse rate.

Product Accessories

1. One hang lace

2. Two batteries

3. One user manual

SPO2

PR

Power
Swith

PR bar graph

Pulse One

Battery Installation

1. Put t wo AAA batteries into the battery cassette observing correct polarities.

2. Install the battery cover by sliding it horizontally in the direction of the arrow as sho wn
below:

Notes: Batteries must be correctly installed. Otherwise, damage might be caused to the
device.

Please put or remove batteries in right order, or is likely to damage the device bracket.
Please remove the batteries if the Oximeter will not be used for a long time.

Hang Lace Installation

1. T hread thinner end of the hang lace through the hanging hole.

2. T hread thicker end of the lace through the threaded end before pulling it tightly.

Maintenance and Storage

1. Replace th e batteries when low voltage lamp is lighted.

2. Clean surface of the fingertip Oximeter before it is used in diagnosis for patients.

3. Remove the batteries from the battery cassette if the Oximeter will not be operated for a
long time.

4. It is best to store the product in a place where ambient temperatures are -20~55°C
(-4~131°F) and humidity is 10%-93%.

5. It is recommended that the product should be kept in a dry environme nt. High humidity
might affect its lifetime or even damage the product.

6. Please follow local ordinances regarding the disposal of used batteries.

Calibrating

1. The functional tester cannot be used to assess the accuracy of the Oximeter.

2. Index 2 that made b y Bioteck company is a function tester. Set Tech to 1, R curve to 2,
then user can use this particular calibration curve to measure the Oximeter.

3. T he test methods used to establish the SpO2 accuracy is clinical testing. The Oximete r
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.

Declaration

EMC of this product comply with IEC60601-1-2 standard.
The materials which user can come into contact is no toxicity and no action on tissues, (I

don’t know what this means) comply with ISO10993-1,-5,-10.

Detailed descriptions of product functions

1. Display Type: OLED display

2. SpO

2

:

Measurement range: 70-99%
Accuracy: ±2% on the stage of 80%-99%; ±3% on the stage of 70%-80%;

3. Pulse Rate:

Measure range: 30-235 BPM
Accuracy: ±2 BPM or ±2%（larger）

Pulse Intensity: Bar graph Indicator

4. Power Requirements:

Two AAA alkaline Batteries

Power consumption: Less than 40mA
Low power indication:

Battery Life:

Two AAA 1.5V, 600mAh alkaline batteries could continuously operate the Oximeter
for as long as 30 hours.

5. Dimension:

Length: 58mm
Width: 32mm
Height: 34mm
Weight: 50g (including two AAA batteries)

6. Environment Requirements:

Operation Temperature: 5~40°C
Storage Temperature: -20~55°C
Humidity: 15%-80% in operation

10%-93% in storage

7. Declaration: EMC of this product complies with IEC60601-1-2 standard.

8. 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 0.6%.

9. Interference Resistance Capacity against Ambient Light: Device work normally
when mixed noise produced by BIO-TEK INDEX Pulse Oximeter tester.

Guidance and Manufacturer’s declaration – electromagnetic emissions-

for all EQUIPMENT and SYSTEMS

Guidance and Manufacturer’s declaration – electromagnetic emission

The Pulse Oximeter is intended for use in the elect ro magn etic e nv ironm ent sp eci fied b elow. The customer of
or the user of the Pulse Oximeter shou ld assure that it is used in such an environment.

Emission test Compliance Electromagnetic environment – guidance

RF emissions
CISPR 11

Group 1 The 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.

RF emission
CISPR 11

Class B The Pulse Oximeter 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.

Possible Problems and resolutions

Problems Possible reason Solution

SpO2 or PR can not
be shown normally

1. Finger is not inserted correctly

2. Patient’s oxygen saturation value is
too low to be measured.

1..Retry by reinserting the finger

2. Try some more times. If you can make sure no
problems exist with the product, please go to a
hospital in a timely manner for exact diagnosis.

SpO2 or PR is erratic

1. Finger might not be inserted deep
enough.

2. Finger is trembling or patient’s body
is moving around.

1. Retry by reinserting the finger.

2. Try not to move around.

The Oximeter can
not be powered on

1. Batteries might be low or missing.

2. Batteries might be installed
incorrectly

3. The Oximeter might be damaged

1. Replace the batteries

2. Please reinstall the batteries.

3. Please contact a customer service center.

Indication lamps are
suddenly off

1. The product is automatically powered

off when no signal is detected for
longer than 8 seconds

2. Batteries might be low.

1. Normal

2. Replace the batteries

“Error3” or
“Error4” Displayed
on screen

1 .Low power

2. Receiving tube being shielded or
damaged together with broken
connector.

3. Mechanical Misplace for
receive-emission tube.

4. Amp circuit malfunction.

1. Replace the batteries

2. Please contact a customer service center

3. Please contact a customer service center

4. Please contact a customer service center

“Error7” displayed on
screen

1. Low power

2. Emission tube damaged.

3. Current control circuit malfunction.

1 Replace the batteries
2 Please contact a customer service center
3 Please contact a customer service center

Symbol Definitions

Symbol Definition Symbol Definition

The equipment type is BF

Heart rate (BPM)

Refer to user manual before
application

Low power indication

SpO2﹪

Hemoglobin saturation

SN

Serial No

Not for continuous monitoring

Date of manufacture

Distributor: EVO Medical Solutions

26378 289th Place
Adel, IA 50003

TEL:[phone]
FAX:[phone]
Toll free :800.759.3038

Web: http://www.evomedical.com
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.