Lanaform PO-100 User manual

P O -10 0
PULSE OXIMETER
OXYGEN
SATURATION PULSE RATE PERFUSION INDEX
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ENGLISH
Introduction
Thank you for choosing the pulse oxime-
ter by LANAFORM.
The Pulse Oximeter is a non-invasive meth-
od used to measure blood oxygen saturation
(SpO2) by checking the percentage of oxy-
gen-saturated haemoglobin as well as the
pulse modulation index (PMI) and heart
ratemeasurement.Thisprocess has been
in regular use now for twenty years and is
proving to be an essential control in medi-
cal practice formaintaining oxygen levels
andpreventing respiratoryproblems. The
value of the oxygen saturation may be re-
garded as dangerous if it is below 90% for
arterial blood. Normal value is 100% under
normal atmospheric conditions.
Please readall the instructions before
using your product, particularly these
basic safety instructions.
The photographs and other images
of the product in this manual and on the
packaging are as accurate as possible,
but do not claim to be a perfect repro-
duction of the product.
Contents
01 Unpacking
02 Contents of the package
03 Symbols
04 Safety precautions
05 Product description
06 Product structure
07 Description of the screen
08 Settings
09 Instructions for use
10 Reading the measurements
11 About the display
12 Replacing the batteries
13 Fixing the strap
14 Cleaning and disinfecting routine
15 Maintenance
16 Technical specications
17 Safety category
18 Storage et transport
19 Manufacturer’s guidelines
and declaration - Electromag-
netic emissions
20 Limited warranty
21 Waste disposal
22 After-sales service
01 Unpacking
Please open the packaging carefully be-
fore use. Check whether all the accessories
are present and whether any components
havebeen damaged during transport and
follow the installation and operating in-
structions in this manual. In the event of
any damage or malfunction, please con-
tact the reseller or Lanaform directly. In
the event of any complaint, you will need
the model of the device, serial number, date
of purchase, your details and your address.
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02 Contents of the package
• 1 pulse oximeter
• 2 AAA batteries (supplied)
• 1 set of instructions for use
• 1 storage bag
• 1 carrying cord
03 Symbols
The following marks and symbols may
appear in the instructions for use, on the
PO-100 and its accessories.
SYMBOL DESCRIPTION
Type BF applied part.
Due attention required.
Action that is prohibited.
Information about
the manufacturer.
Date of manufacture.
Consult the instruc-
tions for use.
This product also complies
with the requirements of di-
rective MDD93/42/EEC.
SYMBOL
DESCRIPTION
Electrical waste must be
sent to a specialist collec-
tion point for recycling.
Level of protection against
water penetration.
Warning
Misuse of the device can
damage the oximeter or
cause physical injury.
Please
note
Misuse of the device can
damage the oximeter or
cause inaccurate readings.
%SpO
2
Symbol of oxygen saturation
bpmPR Symbol of pulse rate
No SpO
2
alarms.
04 Safety precautions
Read the following precautions care-
fully before using the pulse oximeter.
Please note
• Do not try to maintain the oximeter
unless you are a qualified profes-
sional. Only qualied maintenance
professionals are authorised to carry
out internal maintenance ifnecessary.
• The oximeter might not run if you have
poor blood circulation. Rub your nger
to increase circulation or put the de-
vice on another nger.
• Do not use the device for more than
30 minutes without changing ngers.
• This product is not suitable for exam-
ining new-borns.
• Seek prompt medical treatment if the
value measured is beyond the normal
range and you are sure that the instru-
ment is not malfunctioning.
• Do not expose your eyes directly to
the electroluminescent components
of the oximeter because this might
cause damage.
• For further details on clinical limits and
contraindications, please read the rel-
evant medicaldocumentation carefully.
• The following factors may disrupt or
aect the accuracy of the examination:
∙ This product is used in an environment
involving high-frequency devices.
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∙The oximeter probe is place on the
same part of the body or same limb
as with the arterial duct of the blood
pressure cu.
∙The user suers from hypotension,
severe vascular atrophy, severeanae-
mia or lack of oxygen.
∙ The user is in sudden cardiac ar-
rest or in shock.
∙Nail polish or false nails may cause
incorrect oxygen saturation or pulse
readings.
• Take care of the measuring probe lens,
which is fragile.
• Remove used batteries with care. In order
toprotecttheenvironment,usedbatter-
ies should be sent to a collection point
provided for this purpose.
• Remove the batteries when the oximeter
is not in use for more than two months.
• Do not immerse the oximeter in water or
expose it directly to sunlight.
• Do not expose the oximeter to vibra-
tions or shocks.
• Clean the oximeter probe after each
time it is used.
• Do not use the oximeter for purposes not
specied in this manual. Follow the in-
structionsin the chapter “Instructions
for use” and use the oximeter with care.
• The oximeter is not watertight so do no
immerse it in water or any other liquid.
Clean and disinfect the oximeter as de-
scribed inthe “Cleaning and disinfecting
routine” chapter.
• Do not touch the tip of the measur-
ing probe.
• Keep the measuring probe clean to
maintain the accuracy of the readings.
• The ambient temperature must not be
too high or too low. For accurate read-
ings, keep the oximeter at an ambient
temperature for more than 30 minutes
before using it.
• Do not use the oximeter at an ambient
temperature above 40°C (104°F) or be-
low 5°C (41°F). These temperatures are
beyondthe oximeter’soperating range.
• Riskofpollution!Therecommendation
is that the used oximeter should be de-
posited in a recycling centre.
• 2×1.5VAAAbatteries (supplied) arethe
only replaceable accessories of the ox-
imeter. Do not use batteries of other
voltages or specications.
Warning
• Do not use the oximeter in an envi-
ronment containing ammable gases,
ammable anaesthetic or other am-
mable substances.
• Do not use the oximeter in an MRI or
CT environment.
• Do not use the oximeter when it is humid
with overow or water vapour conden-
sation. Do not move the oximeter from
an excessively cold environment to a
high-temperature humid environment.
• Keep the oximeter out of the reach
of children.
• Use of a used oximeter could cause in-
accurate readings.
• The oximeter is not designed to diag-
nose or treat a health problem or illness.
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The results of measurements are pro-
vided for information only.
• Self-diagnostics or self-medication
based on the results obtained are dan-
gerous. Please consult a doctor.
• Do not try to charge dry-cell alkaline
batteries and do not throw them onto
a re. They could explode.
• Do not dismantle the oximeter and do
not try to repair it. It could be perma-
nently damaged.
• During the measuring process, do not
use a mobile phone or any other de-
vice likely to cause electromagnetic
interference.
05 Product description
Based on entirely digital technology, the
nger pulse oximeter measures in a non-in-
vasive manner the actual content (oxygen
saturation) of oxyhaemoglobin (HbO2) in
arterial blood by using the optical trans-
mission method.
The nger pulse oximeter measures the
blood’s oxygen saturation and the pulse
of a human body via the nger’s artery. It
applies to a wide range of areas, such as
families and clinics. Use this instrument
for measuring before or after sport. Use
of this instrument is not recommend-
ed during sports activities. Do not use it
for the continuous treatment of patients.
06 Product structure 1
01
02
03 04
01 OLED screen
02 Power button
03 Battery cover
04 Battery cover lock
07 Description of the
screen 2
01
02
03 04
05
06
08
07
01 Battery level indicator
02 Pulse symbol
03 Pulse modulation index
04 Pulse rate value
05 Oxygen saturation symbol
06 Oxygen saturation value
07 Bar graph
08 Plethysmograph
08 Settings 3
After turning on the oximeter, hold the
power button down for about a second.
The oximeter displays a conguration in-
ter face. Press the button or hold it down to
carry out the corresponding operations:
hold it down to dene a part or press it
once to change option or display mode.
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Adjusting its alarm
Hold the power button down for 1 second
while the oximeter is on. The congu-
ration interface 1 is displayed, as the
illustration shows.
Move “*” to the corresponding option by
continually pressing the power button.
Hold the power button down for 1 sec-
ond to activate/deactivate the alarm: when
ALM is activated and the measured val-
ues of the oxygen saturation of the blood
and pulse exceed the top or bottom lim-
it, the oximeter emits a sound alert. Hold
the power button down for 1 second to
activate/deactivate the beep: when the
beep is activated, a tick-tack will be
heard with the pulse beats when the pulse
rate is being measured. While the “*” re-
mains on the Restore option, hold down
the power button for 1 second to restore
the factory settings.
Brightness settings
Press the power button on the settings
1 interface to select the Brightness op -
tion, then hold the button down to adjust
the brightness on a value between 1 and
5. The higher the value, the higher the
screen’s brightness.
Adjusting the alarm range
On settings interface 2 (hold the power
button down for 1 second when you are
in the settings 1 interface and the “*” sym-
bol is displayed on Alarm Setup), press the
power button to switch between options.
You can dene the upper and lower lim-
its of the “SpO2” oxygenation rate alarm
on this interface as well as the upper and
lower limits of the “PR” pulse rate alarm.
While the “*” symbol remains on option
+/-, hold the power button down for 1 sec-
ond to adjust the option to + or -. In + mode,
select the corresponding option and hold
the power button down to increase the up-
per or lower limit. In - mode, hold down
the power button to reduce the upper or
lower limit. Move “*” to the Leave option
and hold the power button down to return
to the monitoring interface.
09 Instructions for use 4
Insert a nger fully into the oximeter’s
measuring sections. Keep the surface
of the nail pointing upwards and release
the clip. Press the power button to switch
on the oximeter.
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Warning
If you do not insert your nger fully into
the cavity, the measuring result may
be inaccurate.
Warning
Do not allow your nger to vibrate during
the measuring process. Preferably, make
sure your body does not move. Once the
readings have become stable, read the
measured values of oxygen saturation
and pulse on the screen.
Comment: the oximeter will switch o
automatically 10 seconds after remov-
ing your nger.
10 Reading the
measurements
Evaluate the pulsed
oxygen saturation index
Warning
The table below for evaluating your re-
sults does NOT apply to people with certain
pre-existing conditions (for example,
asthma, heart failure, respiratory tract
diseases) and in the event time is spent at
altitudes higher than 1,500 metres. If you
already have an illness, always consult your
doctor for an evaluation of your results.
SPO2 RESULT
(PULSED OXYGEN
SATURATION) IN%
CLASSIFICATION/
MEASUREMENT
TO BE TAKEN
99-94
Normal range
94-90
Reduced range:
Visit to the doc-
tor recommended
<90
Critical range:
Consult a doctor
in an emergency
Evaluate the pulse
modulation index
The Pulse Modulation Index (PMI) must
be between 0.3% and 20%. It uctuates
depending on the patient, the measuring
point and physical state. A very low PMI
valuemayinterferewiththemeasurements.
11 About the display 5
Press the power button continuously
during the monitoring process. The data
monitored and display method will be
displayed cyclically on the OLED screen
in two dierent ways (large fonts and
plethysmograph) and in four directions,
as shown in the illustration.
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12 Replacing the
batteries 6
Replace the batteries when low and when
the symbol ashes on the screen. Install
two AAA dry-cell batteries in the battery
compartment according to the polarity in-
dicated and replace the battery cover.
13 Fixing the strap 7
You can x a strap to the device to make it
easier to carry the pulse oximeter. Slide the
thin end of the strap through the holder as
illustrated. Firmly pull the other end of the
strap through the holder of the narrow end.
14 Cleaning and
disinfecting routine
Cleaning
Turn o the instrument and remove the
batteries before cleaning. Make sure the
instrument looks clean, is free of dust and
dirt. Clean the instrument’s outer surface
(includingthe OLED screen) with 75% med -
ical spirit and a piece of soft, dry cloth.
Make sure the liquid does not run into
the instrument when cleaning.
Do not immerse any part of the instru-
ment in any liquid.
Disinfection
Before measuring with the instrument,
clean the rubber pad with a piece of soft,
dry cloth soaked in 75% medical spirit.
Clean the nger to be measured with
medical spirit for the purposes of disin-
fection before and after use.
Warning
Do not disinfect the instrument by disin-
fecting at a high temperature/high pressure
or with gas.
15 Maintenance
• Remove the batteries from their cas-
ing and store them properly if you do
not intend to use the oximeter for a
lengthy period.
• Store the oximeter between 14°F and
122°F (–10°C to +50°C) and at levels
of humidity of between 10% and 93%.
• Check the oximeter regularly for damage.
• Do not use the oximeter in an envi-
ronment containing ammable gases
or use it in an environment where the
temperature or humidity is excessive-
ly high or low.
• Check the accuracy of the oxygen sat-
uration and pulse rate measurements
usingan appropriate calibration device.
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16 Technical specications
01 Dimensions: 62.0 mm (Width)
× 37.0 mm (Depth) × 32.0 mm
(Length) Weight: 42.5 g (includ-
ing two AAA dry-cell batteries)
02 Peak wavelength range of light
emitted by the probe: red light 660
nm ±3; 905 nm ±5 infrared light.
03 Maximum optical output pow-
er of the probe: 1.2 mw for
infrared light (905 nm).
04 Date of manufacture: see label
05 Normal working condition
Operating
temperature
5°C to 40°C
(41°F to 104°F)
Relative humidity 15% to 80%,
no condensation
Atmospheric
pressure 70 kPa to 106 kPa
Voltage rating
DC 3.0 V
06 Default values and warn-
ing conditions
SETTING VALUE
Oxygen sat-
uration
Upper limit: 100
Lower limit: 94
Heart rate
Upper limit: 130
Lower limit: 50
Warning
condition
When the warning switch
is activated and the ac-
tual measured value
exceeds the predened
range of warning set-
tings, the oximeter emits
a warning sound.
07 Technical settings
SETTING VALUE
DISPLAY
RANGE
Oxygen
saturation
35% to 100%
Heart rate
25 bpm to 250 bpm
RESO-
LUTION
Oxygen
saturation
1%
Heart rate
1 bpm
SETTING
VALUE
ACCURACY OF
MEASUREMENT
Oxygen
saturation
±2% (70% to 100%)
No require-
ment (≤ 69%)
Heart rate
±2 bpm
WARNING RANGE
Oxygen
saturation
Upper limit:
50% to 100%
Lower limit:
50% to 100%
Heart rate
Upper limit:
25 bpm to 250 bpm
Lower limit:
25 bpm to 250 bpm
WARNING
RANGE
Oxygen
saturation
±1% of the pre-
dened value
Heart rate
The highest of ±10%
of the predened
value and of ±5 bpm
PI Low PI Min. 0.3%
17 Safety category
• Type of protection against electric
shocks: internally powered equipment.
• Level of protection against electric
shocks: type BF applied part.
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• Level of protection against water pen-
etration. IP22
• Safety level for use in ammable anaes-
thetic mixtures with air, oxygen or
nitrous oxide: non-AP/APG
• No part of the oximeter’s application
impedes the debrillation load eect.
• No part of the oximeter’s application
impedes the output signal.
• The oximeter is not a permanently in-
stalled device.
18 Storage and transport
The pulse oximeter can be transported
using general transport tools. Avoid vi-
brations, shocks or rain during transport.
The pulse oximeter must be packed and
stored on well-ventilated premises with
no corrosive gas. The ambient tempera-
ture must be between -10°C et +50°C, the
relative humidity must be between 10%
and 93% (with no condensation) and the
atmospheric pressure must be between
50 and 106 kPa.
19 Manufacturer’s guidelines
and statement · Electro-
magnetic emissions
Manufacturer’s guidelines
and declaration · Electro-
magnetic emissions · For all
equipment and systems
Manufacturer’s guidelines and
declaration · Electromagnetic emissions
The PO-100 pulse oximeter is designed
to be used in the electromagnetic
environment specied below. The
customer or user of the PO-100 pulse
oximeter must make sure that he or she
uses it in this type of environment.
Emission test
Compliance
Electromagnetic
environment · Guidelines
RF emissions · CISPR 11
Group 1
The PO-100 pulse oximeter only
uses RF energy for its internal
operation. The RF emissions are
therefore very weak and should
not cause any interference with
the electronic devices nearby.
Manufacturer’s guidelines and
declaration · Electromagnetic emissions
RF emissions · CISPR 11
Category B
The PO-100 pulse oximeter can
be used in any establishment,
including domestic settings
and those directly connected
to the low-voltage public
distribution network supplying
electricity to buildings used
for domestic purposes.
20 Limited warranty
LANAFORM guarantees this product against
any material or manufacturing defect for
a period of two years from the date of
purchase, except in the circumstances
described below.
The LANAFORM guarantee does not cov-
er damage caused as a result of normal
wear to this product. In addition, the guar-
antee covering this LANAFORM product
does not cover damage caused by abu-
sive or inappropriate or incorrect use,
accidents, the use of unauthorized ac-
cessories, changes made to the product
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