Drive DeVilbiss HbO-3000 User manual

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CONTENTS·······································1
FINGERTIP PULSE OXIMETER·············2
FINGER-PULSOXIMETER··················20
PULSIOXÍMETRO·····························41
OXYMÈTRE DE POULS AU DOIGT······62
PULSOSSIMETRO DA DITO················82

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V1.1
FINGERTIP PULSE OXIMETER
General Description
Oxygen saturation (SpO2) is a percentage
of oxygen contained in the blood. ‘S’
indicates saturation, ‘p’ indicates the
pulse and O2is the symbol for oxygen.
Blood cells contain a chemical called
hemoglobin (Hb). When hemoglobin is
combined with oxygen it forms a second
chemical called oxyhemoglobin (HbO2).
As blood travels around the body the
oxyhemoglobin releases the oxygen
where required and then turns back into
hemoglobin. Oxygen levels in the blood
can fluctuate, especially during activity.
Generally normal oxygen levels of a
English

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person is 95% or greater. Less than 95%
may indicate health issues which would
require clinical investigation.Oxygen
deficiency in the blood is referred to as
hypoxia. There are many respiratory
conditions that can result in a patient
becoming hypoxic; COPD (Chronic
Obstructive Pulmonary Disease), OSA
(Obstructive Sleep Apnea) and chronic
bronchitis to name a few. Oxygen
saturation plays an important part for
clinical professionals to be proactive in
patient diagnosis.
Perfusion Index (PI) is related to the
strength of the patients pulse at the site
of measurement. PI is measured as a
percentage (%) and the optimal value is
20% indicating a very strong pulse.
The drive DeVilbiss Healthcare HbO-
3000 ngertip pulse oximeter is compact
in size, user friendly and features an
OLED screen display. SpO2diagnosis

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requires the patient to simply wear
the device on their finger. The oxygen
saturation and pulse rate values will
be displayed on the device screen. The
drive DeVilbiss Healthcare HbO-3000
has been designed and tested to provide
repetitive, accurate screening for SpO2
patient diagnosis.
Measurement Principle
The principle measurement of an
oximeter uses a mathematical formula
known as the ‘Lambert Beer Law’
according to spectrum absorption
characteristics of reductive hemoglobin
(RHb) and Oxyhemoglobin (HbO2)
in glow and near-infrared zones.
Photoelectric Oxyhemoglobin Inspection
Technology is adopted in accordance
with capacity pulse scanning and
recording technology, so that two beams
of lights at different wavelengths (660nm

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glow and 905nm near infrared light) can
be applied to the fingertip via a clamp
finger-type sensor. A measured signal
obtained by a photosensitive element,
and processed via the device electronics
and microprocessor will be displayed on
the oximeter’s screen display.
Diagram of Operation Principle
1.Red and Infrared-ray Emission Tube
2.Red and Infrared-ray Receipt Tube
Product Operation Scope
The HbO-3000 fingertip pulse oximeter
is a non-invasive device designed for
oxygen saturation (SpO2) and pulse rate
detection of adult and pediatric patients
in the home and clinical environments.

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It has not been designed for continuous
monitoring.
Precautions for use
1. Carefully read this user manual before
using the HbO-3000 fingertip pulse
oximeter.
2. Do not use the HbO-3000 fingertip
pulse oximeter in an MRI or CT
environment.
3. A pulse oximeter is intended only
as a supplementary accessory in
patient assessment. It must be used in
conjunction with other methods of
clinical diagnosis.
4. Frequently check application site to
determine correct positioning of the
sensor.
5. Check patients circulation before
use and refrain from using if the skin
becomes sensitive.
6. Prolonged use of the device or the

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patient’s condition may require
changing the site of the sensor
periodically.
7. Autoclaving, ethylene oxide sterilizing,
or immersing the HbO-3000 fingertip
pulse oximeter in liquids will damage
the device.
8. The following conditions could cause
inacurrate readings:
•High levels of dysfunctional haemoglob-
ins such as carboxyhaemoglobin or
methemoglobin.
•Intravascular dyes such as indocyanine
green or methylene blue.
•High ambient light.
•Excessive patient movement.
•High-frequency electrosurgical
interference.
•Venous insufciency.
•Application of a blood pressure cuff,
arterial catheter, or intravascular line.
•Hypotension, severe vasoconstriction,

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severe anemia, or hypothermia.
•Cardiac arrest or shock.
•Fingernail polish or cosmetic ngernails.
Please comply with local authority
regulations when disposing/recycling of
the device and batteries.
Product features
1. The HbO-3000 Fingertip pulse oxim-
eter is light weight, compact and
easy to use.
2. Low power consumption only requires
2 x AAA batteries. (20 hours).
3. A low voltage warning will be displayed
on the device screen when batteries
are low.
4. The product will automatically power
off after 8 seconds if no signal is
deteced.
5. No maintenance required.
Operation Instructions

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The HbO-3000 features six different
directional screen settings including
a pulse rate bar, plethysmography
waveform and a PI indicator. In addition,
the HbO-3000 has 5 different brightness
levels for user preference.
Parameter Settings
Press the power button (>0.5s), the
oximeter will enter into the parameter
setting screen. There are two parameter
sub menu screens:
Devices with sound/alarm function
When the “*”signal is shown on the
“Sounds Setup”, press the button(>0.5s)
/Min /Mi n
/Min
/Mi n
/Mi n
/Mi n
/Min

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and enter into the sounds setting menu,
pressing the button in turn will select
the item to be changed, Press and hold
the button to change the parameter.
Select“+”or “-” to increase/decrease the
number values.
When the “*”signal is shown on the “Alm
Setup”, press the button (>0.5s) and
enter into the alarm setting menu. Press
the button to set the on/off for the alarm
and beep.
When the “*”signal is shown on the
“Restore”, press the button (>0.5s) to
default to factory settings.
The ‘Demo’ feature is for demonstration
purposes only.
Settings
Alm Setup *
Alm on
Beep off
Demo off
Restore OK
Brightness 4
Exit *
Settings
Sounds Setup *
SpO2 Alm Hi 100
SpO2 Alm Lo 90
PR Alm Hi 130
PR Alm Lo 50
+/- +
Exit

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Battery Installation
1. Open the battery compartment by
sliding the battery door open.
2. Place the two AAA batteries into the
battery compartment ensuring correct
position.
3. Slide the battery door back in position
ensuring battery compartment is fully
closed.
Important:
•To prevent damage ensure correct
polarity when installing/replacing
batteries.
•To prevent damage install negative (-)
side of battery rst.
•For extended periods of non-use
remove the batteries from the oximeter.

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Lanyard Installation
1. Thread the thin end of the lanyard
through the hole at the rear of the case.
2. Loop the wider end of the lanyard
through the thin end before pulling it
tight.
Operation Instructions
1. Install two AAA batteries (See battery
installation).
2. Insert finger into the oximeter as
shown in Pic 1.The nger nail must be
facing upwards.
3. Switch the device on by pressing the
power button.
4. Avoid excessive body movement
Pic 1.

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during measurement.
5. Measurement data will be displayed
on the device screen.
6. For best performance and accurate
measuring, apply the HbO-3000 to the
finger that provides the highest PI
value.
7. Remove nger to stop measurement.
Device will automatically switch off
after 8 seconds.
Note:Use sterile wipes to clean the
inside and outer case of the HbO-3000
oximeter between patients.The HbO-
3000 oximeter is constructed of latex free
materials.
Product Specications
1. Display Type: OLED (Organic Light
Emitting Diode).
2. SpO2:
Measurement range:35%-100%
Accuracy:70% - 99% ±3% ≤69%, no

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denition
3. Pulse Rate and PI:
Measurement range:30 - 250 BPM
Accuracy: 30 - 250 BPM ±2%
Pulse rate display model: Bargraph
Indicator
PI parameter range: 0-30%. 20%-30%
Unspecied
PI Accuracy: 0.1%
4. Power Requirements:
Two AAA alkaline batteries
Power consumption: Less than 30mA
Low power indication: The low voltage
warning will illuminate when the
voltage is less than 2.6V(±0.2V)
Battery Life: Two AAA 1.5V,600mAh
alkaline batteries 20 hours operation
5. Dimensions:
LxWxH: 57mm x 31.5mm x 30.5mm
6. Environment Requirements:
Operating Temperature:5 - 40℃
Storage Temperature: 20- 70℃

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Ambient Humidity:
Operating:15%-90%;
Storage:15%-93%
7. EMC of this product complies with
IEC60601-1-2 standards.
8. Measurement performance in low
perfusion condition: Required test
equipment (FLUKE-INDEX 2XL)
the pulse wave is functional without
failure when the simulation pulse wave
amplitude is set at 0.4%.
9. Interference Resistance Capacity
against ambient light: Device works
normally. Mixed noise produced by
FLUKE-INDEX 2XL.
Product Accessories
1. Lanyard
2. 2 x AAA batteries
3. User manual
Maintenance and Storage

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•Replace the 2 x AAA batteries when low
voltage warning is indicated.
•Clean the internal/external surfaces of
the HbO-3000 ngertip oximeter before
and after patient use.
•For extended periods of non-use
remove the batteries from the oximeter.
•Storage conditions: Ambient tempera-
ture 10℃-40℃(14-104℉) and relative
humidity 10%-80%.
•Store the unit in a damp free, dry
environment.
•Please comply with local authority
regulations when disposing/recycling of
the device and batteries.
Calibration Method
Factory calibration is conducted using
a FLUKE-INDEX 2XL oxygen analogue
meter, and BCI oximeter calibration
meter.
Note: The test methods used to

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establish the SpO2accuracy requires
clinical testing. The oximeter is 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.
Troubleshooting
Problems Possible
reason Solution
SpO2or
Pulse Rate
not being
displayed
Finger is not
inserted
correctly
Re-insert
or try a
different
nger
SpO2or
Pulse Rate
not being
displayed
Excessive
body
movement
Reduce and
stabilise
body
movemen

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The
oximeter will
not switch
on
Exhausted
batteries
Batteries
incorrectly
installed
Faulty
oximeter
Replace
batteries
Reinstall the
batteries
Please
contact your
local
customer
service
centre
Device
display
turns off
suddenly
The product
will automat-
ically power
off after 8
seconds if no
signal is
detected
Exhausted
batteries
Normal
Replace the
batteries