4 - BATTERY INSTALLATION
1. Put the two AAA batteries into battery compartment in correct polarities.
2. Push the battery cover horizontally along the arrow shown in figure 3.
WARNINGS:
• Battery polarities should be correctly installed,
otherwise, damage may be caused to the equipment.
• Please remove the batteries if the oximeter will be stored
for more than 30 days.
• Please remove the batteries if you want turn off the oximeter.
Otherwise it is always in sleep mode.
• Battery may leak or explode if used or disposed off improperly.
5 - OPERATING GUIDE
5.1 Application Method
1. Remove the battery cover, and insert the two AAA batteries following polarity markings indicated
inside of the battery compartment, then reposition the cover.
2. Hold the oximeter with the display facing toward you, slide your finger into the opening probe of the
device as shown below (Figure 4), until the fingertip touches the built-in stop guide. For best results,
make sure the finger is centered within the finger guide.
3. Press the button to activate the oximeter from sleep mode. The measurement interface will appear
in 3 seconds.
4. The measurement result will appear on the screen within 10 seconds.
5. The oximeter will turn to sleep mode automatically within 8 seconds after the finger is removed.
1.
Press the bottom to open the probe
2.
Insert the finger into the bottom of machine
3.
Press the operating button to activate the oximeter
Figure 4. Operation Guide
5.2 Notes for Operation
• The index finger, middle finger, and ring finger are suitable positions for the monitor.
• Excessive or rapid movement may affect measurement.
• Improper sensor placement may affect the measurement accuracy.
• The oximeter can be reused after cleaning and disinfection.
• The measurement is most accurate when the oximeter and the heart are at the same level.
• (Only for Clearwave II) The plethysmogram can be used as pulse intensity indicator.
The displayed parameters might be unreliable with the disorderly plethysmogram.
• (Only for Clearwave) The bar graph can be used as pulse intensity indicator.
The displayed parameters might be unreliable with un-periodic bar change.
• The displayed parameters will show invalid indicator as ‘---’ if signal quality is very low.
• The displayed parameters will show invalid indicator as ’---’ if oximeter fault occurs.
• The oximeter will shut down after 5 minutes if continuous testing.
6 - SPECIFICATIONS
6.1 Classification
Type of protection against electric shock............................ II (Internally powered equipment)
Degree of protection against electric shock....................... Type BF-Applied part (non-defibrillation proof)
Operating mode............................................................................ Spot checking
Degree of protection against hazards of explosion......... Ordinary equipment: Not protected
Equipment type............................................................................ Fingertip oximeter
6.2 Measurement Specifications
SpO
2
declared accuracy
Range(
σ
*)............................................................................ 70% ~ 99% ± 2 digits
0% ~ 69%: unspecified
Resolution........................................................................... 1%
Update Period.................................................................... 1s
Averaging Time................................................................. 8s
PR declared accuracy
Range(
σ
*)............................................................................ 25 ~ 250 : ± 3 digits
Resolution........................................................................... 1bpm
Update Period.................................................................... 1s
Averaging Time................................................................. 8s
6.3 Power Requirements
Specification of alkaline batteries............................................ Two 1.5V (AAA)
Operating voltage..........................................................................DC 2.5-3V
6.4 Environmental Specifications
Temperature
Operating............................................................................ +41° to + 104°F / 5° to +40°C
Storage/Transportation................................................. -4° to + 140°F / -20° to +60°C
Humidity
Operating............................................................................ 10 ~ 95%, non-condensing
Storage/Transportation................................................. 10 ~ 95%, non-condensing
Atmosphere Pressure
Operating............................................................................ 70 ~ 106kpa
Storage/Transportation................................................. 50 ~ 107.4kpa
Thank you for purchasing the SureLife Pulse Oximeter. This manual contains the instructions necessary
to operate the product safely and in accordance with its function and intended use. Observance of this
manual is a prerequisite for proper product performance and correct operation and ensures patient and
operator safety. Read this manual carefully before using the fingertip pulse oximeter. This product is a
reusable medical device. The lifespan of the product is 2 years. This device is a prescription use device.
1 - SAFETY
1.1 Contraindications
Do NOT use oximeter in a magnetic resonance (MR or CT) environment.
1.2 Warnings
Keep the oximeter away from young children. Small parts such as the battery door, battery, and lanyard
may be choking hazards.
1.3 Cautions
• Do not use the oximeter in the presense of flammable anesthetics.
• The oximeter needs to be used according to information provided in this user manual.
• The equipment is NOT intended for neonate and infant.
• Do not use a damaged oximeter as it may affect measurement performance.
• Do not place the oximeter on the same hand/arm when using a blood pressure monitor or cuff.
• Do not use the oximeter for more than 5 minutes without relocating the device to another finger.
• Do not place the oximeter on edema or fragile tissues.
• Do not use the oximeter as the only basis for making medical decisions, it is intended only to be used
as additional information that you can give to your licensed health care professional.
• Do not use the oximeter in high frequency environments such as near electro-surgical equipment.
• Do not place the oximeter in liquid.
• Follow local disposal and recycling laws for the oximeter and its components, including the batteries.
• Do not stare at the light (infrared is invisible) emitted from the oximeter as it is harmful to the eyes.
• For clinical limitations and contraindications, please carefully review the medical literature
• The equipment is just a clinical diagnosis of auxiliary equipment. The physiological data displayed on
the equipment are for reference only and can not be directly used for diagnostic interpretation.
• Not suitable for the users with arrhythmia/heart failure/Low perfusion (PI<0.3)/finger trembling.
• Not suitable for the users with large finger size or exceeding pulse oximeter’s finger measurement
cavity size.
• Please don’t use the thumb and tail finger to measure.
• Discomfort or pain may appear if using the equipment ceaselessly, especially for microcirculation
barrier patients, it recommended that the equipment should not be used on the same finger more
than 5 minutes.
• The oximeter is designed to measure the percentage of arterial oxygen saturation of functional
hemoglobin. Any of the following conditions may reduce the performance of the oximeter:
- Flickering or very bright light
- Moisture in the oximeter
- Body weight less than 44lbs (20kgs)
- Weak pulse quality (low perfusion)
- Venous pulsations
- Low hemoglobin
- Cardiogreen and other intra-vascular dyes
- Carboxyhemoglobin
- Methemoglobin
- Dysfunctional hemoglobin
- Artificial nails or fingernail polish
- The finger is too cold
- Patients with abnormal circulation of finger endings caused by copd.
2 - THE BASICS
The pulse oxygen saturation is the percentage of HbO
2
in the total Hb in the blood, so-called the O
2
concentration in the blood. It is an important bio-parameter for respiration. A number of diseases relating
to the respiratory system may cause the decrease of SpO
2
in the blood, furthermore, some other causes
such as the malfunction of the human body’s self-adjustment, damages during surgery, and the injuries
caused by some medical checkups would also lead to the difficulty of oxygen supply in human body.
The corresponding symptoms would appear as a consequence, such as vertigo, impotence, vomit etc.
Some symptoms may be serious enough to cause significant harm. Therefore, prompt information
concerning the patients SpO
2
can help doctors discover potential problems, and is of great importance
in the clinical and medical field.
2.1 Principle
The Principle of the oximeter is as follows: an experience formula of data process is established making
use of the Lambert Beer law according to Spectrum Absorption Characteristic of Reductive hemoglobin
(Hb) and oxyhemoglobin (HbO
2
) in glow & near-infrared zones. The operation principle of the device
is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse
Scanning Recording Technology, so that two beams of different wavelengths of light can be focused
onto the human nail tip through a perspective clamp finger-type sensor. The signal is obtained and
measured by a photosensitive element. The information acquired will be shown on screen through
treatment in electronic circuits and microprocessor.
3 - INTRODUCTION
3.1 Intended Use
The Pulse Oximeter is a portable, convenient, non-invasive device, used to monitor arterial
hemoglobin oxygen saturation (SpO
2
) and pulse rate. The personal application are adult patients
(weight: >66lbs (30kgs)) and pediatric patients (weight: 44-66lbs (20-30kgs)). We recommend using
the index finger, middle finger, or ring finger as suitable positions for the monitor. It is intended for
spot-checking or attended-care monitoring in home health care and medical facilities.
WARNING:
• This pulse oximeter is intended to be used only by clinical professionals or under their guidance.
It must only be used by persons who have received adequate training in its use. Anyone unauthorized
or untrained must not perform any operation on it.
CAUTIONS:
• This pulse oximeter is intended for use in
hospitals, clinical institutions, or healthcare communities.
• The pulse oximeter is NOT designed for a newborn or infant. For adults and children, a finger thickness
between 8 - 25.4mm is recommended.
NOTES:
• The probe is the opening in the middle of the equipment in which the finger is inserted.
• The probe is the Applied Part of the equipment.
3.2 Features
• The pulse oximeter is small in size, lightweight, and easy to carry.
• Easy, one-button operation.
• There are two modes: sleep and measure.
• Automatic sleep mode after 8 seconds with no signal.
NOTES:
• Press the power button to activate oximeter (measure mode) from sleep mode.
Function
Clearwave (FS10D)
Clearwave II (FS20D)
Display
LED
OLED
SpO
2
parameter measurement
Y
Y
Pulse rate parameter measurement
Y
Y
Bar graph display
Y
Y
Battery display
Y
Y
Automatically enters sleep mode
Y
Y
Pulse waveform display
—
Y
Four direction display
—
Y
Symbol
Definition
Symbol
Definition
Symbol
Definition
Symbol
Definition
% SpO
2
The Pulse Oxygen
Saturation (%)
Serial Number
Battery Positive
Electrode
BF Type Applied Part
PR
Pulse Rate (BPM)
The Device has no
Alarm System
Battery Cathode
Electrode
Manufacturer
IPX2
T
he Product is
Protected Against
Harmful Effects of
Dripping Water per
IBC 60529.
Date of
Manufacturer
Caution, Consult
Accompanying
Documents
This Item is Compliant
with Medical Device
Directive 93/42/EEC
Power indication (some models have no battery capacity indicator, but have low battery indicator)
3.4 Functions
3.3 Front View
3.5 Symbols
USER MANUAL
Figure 1. Oximeter Schematic Diagram
Figure 3. SureLife Oximeter
Battery Installation
Light Emitting Diode
Finger
Photo Detector
Probe Body
Figure 2. Front View of Clearwave (FS10D)
Figure 2. Front View of Clearwave II (FS20D)
Pulse Bar Graph
Power Button
Power Indication
SpO
2
Value
Pulse Rate Value
Power Indication
Pulse Bar Graph
Power Button
Heartbeat Mark
Pulse Waveform
SpO
2
Value
Pulse Rate Value
Pulse Oximeter
99
70
PRbpm
%SpO
2
70
99
%SpO
2
PR bpm
- -
+
+
