Health Ox - Magnifying Aids

Health Ox
Fingertip Pulse Oximeter
Oxymetre de Pouls Digital
Oximetro de Pulso Tactil
Item # 18710
DRIVE MEDICAL
99 Seaview Blvd
Port Washington, NY 11050
www.drivemedical.com
English
Drive Health-Ox
Fingertip Pulse Oximeter
3
1.Measurement principle
The Oximeter displays functional oxygen saturation. The oximeter’s algorithm uses the
Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin
(RHb) and Oxyhemoglobin (O2 Hb) 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 880nm near infrared light) can be focused
onto human nail tip through perspective clamp fi nger-type sensor. Then measured signal
can be obtained by a photosensitive element, information acquired through which will be
shown on two groups of LEDs through process in electronic circuits and microprocessor.
2.Precautions for use
• Operation of 18710 may be affected by the use of an electrosurgical unit (ESU).
• The 18710 must be able to measure the pulse properly to obtain an accurate SpO2
measurement. Verify that nothing is hindering the pulse measurement before replying on
the SpO2 measurement.
• Do not use the 18710 in an MRI or CT environment
• Do not use the 18710 in situations where alarms are required. The device has no alarms.
• Explosion hazard: Do not use the 18710 in an explosive atmosphere.
• The 18710 is intended only for non-medical use for healthy people to monitor their pulse
and blood oxygen levels while exercising.
4
• Check the pulse oximeter sensor application site frequently to determine the positioning
of the sensor and circulation and skin sensitivity of the user.
• Before use, carefully read the manual.
• The 18710 has no SpO2 alarms, it is not for continuous monitoring, as indicated by the
symbol.
• Prolonged use or the user’s condition may require changing the sensor site
periodically. It is recommended that the sensor should not be applied to the same finger for over 2 hours.
3. Inaccurate measurements may be caused by
• Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing
the sensors in liquid which may cause inaccurate readings. The device is not intended
for sterilization.
• Signifi cant levels of dysfunctional hemoglobin’s (such as carbonxy- hemoglobin or met
hemoglobin)
• Intravascular dyes such as indocyanine green or methylene blue
• SpO2 measurements may be adversely affected in the presence of high ambient light.
Shield the sensor area from direct sunlight or indoor lighting.
• Excessive user movement
• High-frequency electrosurgical interference and defi brillators
5
• Venous pulsations
• Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or
intravascular line
• The user has hypotension, severe vasoconstriction, severe anemia, or hypothermia
• The user is in cardiac arrest or is in shock
• Fingernail polish or false fi ngernails may cause inaccurate SpO2 readings.
• Follow local ordinances and recycling instructions regarding disposal or recycling of the
device and device components, including batteries.
4. Technical Specifications
Display Type: LED display
- SpO2 Measurement Range: 0%-99%
Accuracy: ±2%; ≤70% no defi nition.
- Pulse Range Measurement Range: 30 – 250 bpm,
Accuracy: ±2 bpm or±2% (select larger) for Pulse Rate.
Power Requirement: Two AAA 1.5V alkaline batteries
Low Consumption: Less than 25mA
Measurement Accuracy: SpO2 Accuracy: ±2%; ≤70% no defi nition
- No defi nition of less than 70%
- Pulse rate Accuracy : ±2 bpm or±2% (select larger) for Pulse Rate.
6
The product will automatically be powered off when no signal is in the product for
longer than 5 seconds.
Dimension: Length: 56mm~62mm,
Width: 32mm~38mm ;
Weight: 45g~60g (including two AAA batteries)
Environment Requirements: Operation Temperature: 50°F ~ 104°F / 10°C ~ 40°C
Storage Temperature: -40°F ~ 140°F / -40°C ~ 60°C
5.Product Properties
5.1 Operation of the product is simple and convenient
5.2 The product is small in volume, light in weight (total weight is about 50g including
batteries) and convenient in carrying
5.3 Power consumption of the product is low and the two originally-equipped two AAA
batteries can be operated continuously for 30 hours.
5.4 Low voltage warning will be indicated in visual window when battery voltage is so low
that normal operation of the Oximeter might be infl uenced.
5.5 The product will automatically be powered off when no signal is in the product for
longer than 5 seconds.
7
6. Product Intended Use
Intended Use:
Fingertip Pulse Oximeter 18710 is a portable non-invasive, spot-check, oxygen saturation
of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric users at home or
while exercising.Not for continuously monitoring.
The 18710 requires no routine calibration or maintenance other than replacement of
batteries.
7. Operation Instructions
7.1 Installing two AAA batteries into battery cassette before covering its cover.
7.2 Open the clamp as illustrated in the picture below
7.3 Plug one of fi ngers into rubber hole of the Oximeter (it is best to plug the fi nger
thoroughly) before releasing the clamp
7.4 Press the switch button once on front panel.
7.5 Keep your finger and body still while taking measurements.
7.6 Read correspondent datum from display screen.
7.7 One display mode.
8
Turn on the Oximeter. Each time you press the power switch, the Oximeter will
s the power switch, the Oximeter will
reset the display and restart its measurements.
s.
our
ch
lse
When your fi nger is plugged into the Oximeter, your nail surface must be upward.
Brief Description of Front Panel
User pulse quality signals are indicated as such by the amplitude of the bar graph.
The higher the amplitude,
SpO2the stronger the pulse signal.
Pulse Column
PR
Power Switch
9
9. Product Accessories
. Product Accessories
9.1 One Lanyard
One 9.2
Lanyard
Two batteries
Two 9.3
batteries
One instruction manual
One 9.4
instruction
manualboot
One protective
One protective boot
10. Battery
Installations
0. Battery
Installations
10.1two
Put AAA
the two
AAA batteries
into battery
cassette
in correct
polarities.
1 Put the
batteries
into battery
cassette
in correct
polarities.
10.2
the battery
cover horizontally
the arrow
shown
below:
2 Push
thePush
battery
cover horizontally
alongalong
the arrow
shown
asas
below:
tes: Notes:
polarities
must
correctly installed.
ttery Battery
polarities
must
bebecorrectly
installed.
herwise,
damagedamage
might be
caused
to device.
Otherwise,
might
be caused
to device.
Please
put or remove
batteries
in right
order, or
or isis
ease put
or remove
batteries
in right
order,
likely to damage
the device
bracket.
ely to damage
the device
bracket.
Please remove the battery if the Oximeter will not be
ease remove
battery
used forthe
a long
time. if the Oximeter will not be
ed for a long time.
11.Hang Lace Installations
1.Hang Lace Installations
11.1 Thread thinner end of the hang lace through the hanging hole.
.1 Thread
end ofend
theof
hang
lacethrough
through
the
hanging
hole.
11.2 thinner
Thread thicker
the lace
the
threaded
end
before pulling it tightly.
.2 Thread thicker end of the lace through the threaded end before pulling it tightly.
10
12. Maintenance and Storage
12.1 Replace the batteries timely when low voltage lamp is lighted
12.2 Clean surface of the fi ngertip Oximeter before it is used
12.3 Remove the batteries inside the battery cassette if the Oximeter will not be operated
for a long time
12.4 It is best to preserve the product in a place where ambient temperatures –40~60°C
(- 40~140°F) and humidity is ≤95%
It is recommended that the product should be kept in a dry environment. Wet ambient
might affect its lifetime and even might damage the product.
Cleaning the 18710
Clean inside of Oximeter with a soft cloth dampened with 70% isopropyl alcohol. Clean the
test fi nger using alcohol before and after each test.
Do not pour or spray and liquids onto the Oximeter. Do not allow any liquid to enter any
openings in the device. Allow the Oximeter to dry thoroughly before reusing.
13. Calibrating the 18710
• 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.
11
14. Possible Problems and resolutions
Problems
Possible Reason
Solution
SpO2% or pulse
rate can not be
shown normally
1. Finger is not plugged correctly
2. User’s SpO2 value is too low to be
measured
1. Retry by plugging the finger
2. There is excessive illumination
3. Measure more times, If you can make sure about no problem existing in the product. Please go to
a hospital timelyfor exact diagnosis
SpO2% or pulse rate
is shown unstably
1. Finger might not be plugged deep
enough
2. Excessive user movement
1. Retry by plugging the fi nger
2. Be calm.
The Monitor can not
be powered on
1. No battery or low power of battery
2. Battery might be installed incorrectly
3. The Monitor might be damaged
1. Please replace battery
2. Please reinstall the battery
3. Please contact with local customer service centre
Indication is
suddenly off
1. The Oximeter is automatically
powered off when no signal is
detected longer than 5 seconds
2. The batteries power is too low to work
1. Normal
2. Replace the battery
12
15. Declaration
Guidance and Manufacture’s declaration – electromagnetic emissionsFor all EQUIPMENT and SYSTEMS
Guidance and Manufacture’s declaration - electromagnetic emission
Guidance and Manufacture’s declaration – electromagnetic environment specifi ed below. The customer or
the user of the Pulse Oximeter (18710) should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic Environment – guidance
RF emissions CISPR 11
Group 1
The pulse Oximeter (18710) uses RF energy
only for very low and is not likely to cause
interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not Applicable
Voltage fl uctuations/ flicker
emissions
IEC 61000-3-2
Not Applicable
The pulse Oximeter (18710) 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.
13
Guidance and Manufacture’s declaration – electromagnetic immunityFor all EQUIPMENT and SYSTEMS
Guidance and Manufacture’s declaration - electromagnetic immunity
Guidance and Manufacture’s declaration – electromagnetic environment specifi ed below. The customer or
the user of the Pulse Oximeter (18710) should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance Level
Electromagnetic Environment – guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
+/- 6kV contact
+/- 8kV air
+/- 6kV contact
+/- 8kV air
Floors should be wood, concrete or
ceramic tile. If fl oor are covered with
synthetic material, the relative humidity
should be at least 30%.
Power frequency
(50/60 Hz) magnetic
fi eld
IEC 61000-4-8
3A/m
3A/m
Power frequency magnetic fields
should be at levels characteristics of a
typical location in a typical commercial or
hospital environment.
14
Guidance and Manufacture’s declaration – electromagnetic immunityFor all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and Manufacture’s declaration - electromagnetic immunity
Guidance and Manufacture’s declaration – electromagnetic environment specifi ed below. The customer or
Guidance and Manufacture’s declaration – electromagnetic immunitythe user of the Pulse Oximeter
(18710) should
assure that
thatare
it isnotused
in such an environment.
For all EQUIPMENT
and SYSTEMS
LIFE-SUPPORTING
Guidance and Manufacture’s declaration – electromagnetic immunity
For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and Manufacture’s declaration - electromagnetic immunity
Immunity Guidance
IEC 60601
Compliance Electromagnetic
and Manufacture’s declaration
– electromagnetic
environment
speci
ed below.
The customer
or
Environment
– guidance
Guidance
and Manufacture’s
declaration
- electromagnetic
immunity
thetest
userlevel
of the Pulse
Oximeter (18710) should assure that it is used in such an environment.
test
Level
Guidance and Manufacture’s declaration – electromagnetic environment specied below. T
the user of the Pulse Oximeter (18710) should assure that it is used in such an environmen
Compliance
IEC
60601
Immunity
Portable
and
mobile
RF
communications
equipment
should
be
used
no
Electromagnetic
Environment
–
guidance
Level
test level
test
Compliance
IECof
60601
Immunity
closer
to any part
thecommunications
Pulse
Oximeterequipment
(18710),should
including
Radiated 3 V/m
3 V/m
Electromagnetic
Environment – gu
Portable
RF
be cables, than
Level
test level
test and mobile
3 V/m
used
no
closer
to
any
part
of
the
Pulse
Oximeter
(18710),
including
Radiated
the recommended separation distancePortable
calculated from
ap- equipme
mobilethe
RF equation
communications
RF
80 MHz to
cables, than the3 recommended
separation distanceand
calculated
RF80 MHz to
3 V/m
V/m
used
to any part of the Pulse Oximeter (
Radiated
plicable
toequation
the frequency
oftothe
2.5 GHz
from
the
thetransmitter.
frequency
of no
thecloser
transmitter.
IEC
80 applicable
MHz to
IEC
2.5 GHz
cables, than the recommended separation distanc
RF
3 V/m
Recommended
separation
distance
61000-4-3
Recommended
separation
distance
2.5
GHz
from the equation applicable to the frequency of th
IEC
61000-4-3
d=
Recommended separation distance
MHz
to 800
MHzMHz
P 8080
61000-4-3
MHz
to 800
d=
P 80 MHz to 800 MHz
800
MHz
to 2.5
d=
MHz
to 2.5
GHzGHz
P 800
d=
800transmitter
MHz
P
Where
themaximum
maximum output
power
rating
of theof
transmitter
in to 2.5 GHz
Where
P Pis isthe
output
power
rating
the
in watts
(W) according to the transmitter manufacturer and d is the
Where
thedmaximum
output power rating of th
(W)watts
according
toseparation
the transmitter
manufacturer
and
is the recommended
recommended
distance in
metres
(m). P is
watts
(W) according
to the transmitter manufacture
Field
strengths
from

xed
RF
transmitters,
as
determined
by
an
separation distance in metres
(m). Fieldrecommended
strengths from
fixed RFdistance
transmitseparation
in metres (m).
electromagnetic site survey a, should be less
than the compliance
Fieldsite
strengths
xed RFbe
transmitters,
ters,
as indetermined
by an
electromagnetic
surveyfrom
a, should
less than as dete
b
level
each frequency
range.
a
electromagnetic
site
be less than
maylevel
occur
ineach
the vicinity
of equipment
marked
withsurvey , should
theInterference
compliance
in
frequency
range.
b
b
level
in
each
frequency
range.
following symbol:
may
occur inwith
the vicinity of equipmen
Interference may occur in the vicinity ofInterference
equipment
marked
following symbol:
NOTE 1: At 80 MHz and 800 MHz, thefollowing
higher frequency
symbolrange applies.
NOTE 2: These guidelines may not apply in all situations, Electromagnetic propagation is affected by
3.5
E1
7
E1
3.5
E1
7
E1
NOTE
1: Atand
80 MHz
and 800 MHz, the higher frequency range applies.
absorption and reection structures,
objects
people.
NOTE 2: These guidelines may not apply in all situations, Electromagnetic propagation is a
NOTE 1: At 80 MHz and 800 MHz, the higher frequency
applies.
reection structures, objects and people.
- absorption
12 -rangeand
NOTE 2: These guidelines may not apply in all situations, Electromagnetic propagation
- 12is-affected by
absorption and refl ection structures, objects and people.
15
a Field strengths from fi xed transmitters, such as base station for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fi xed RF transmitters, an
electromagnetic site survey should be considered. If the measured fi eld strength in the location in which
the Pulse Oximeter (18710) should be observed to verify normal operation. If abnormal performance is
observed, additional measurements may be necessary, such as reorienting of the relocating the Pulse
Oximeter (18710).
b Over the frequency range 150 kHz to 80 MHz, fi elds strengths should be less than 3 V/m
a Field astrengths
Field strengths
from xed
from
transmitters,
xed transmitters,
such assuch
baseas
station
base for
station
radiofor
(cellular/cordless)
radio (cellular/cordless)
telephones
telephones
and
and
land mobile
land radios,
mobile amateur
radios, amateur
radio, AM
radio,
andAM
FMand
radio
FM
broadcast
radio broadcast
TV and
broadcast
TV broadcast
cannot be
cannot
predicted
be predicted
t
t
Recommended
separation
distances
between
portable
andand
mobile
communications
heoretically
heoretically
with accuracy.
with
accuracy.
To assess
To assess
the electromagnetic
the
electromagnetic
environment
environment
due RF
to due
xed
to
RFxed
transmitters,
RF transmitters,
an equipment
an
electromagnetic
electromagnetic
site survey
site should
survey
be
should
considered.
be considered.
If the measured
If theSYSTEMS
measured
eld strength
that
eld strength
inare
the location
in the
location
in whichin which
and the EQUIPMENT
or SYSTEMS
-For all
EQUIPMENT
and
not
LIFE-SUPPORTING
the Pulse
theOximeter
Pulse Oximeter
(18710)(18710)
should be
should
observed
be observed
to verifytonormal
verify operation.
normal operation.
If abnormal
If abnormal
performance
performance
is
is
observed,
observed,
additional
additional
measurements
measurements
may be may
necessary,
be necessary,
such assuch
reorienting
as reorienting
of the relocating
of the relocating
the Pulse
the Pulse
Oximeter
Oximeter
(18710).(18710).
Recommended
separation
distances between portable and mobile RF communications equipment
b Over btheOver
frequency
the frequency
range 150
range
kHz150
to 80
kHz
MHz,
to 80elds
MHz,strengths
elds strengths
should be
should
less be
than
less
3 V/m
than 3 V/m
and Pulse Oximeter
(18710)
Recommended
Recommended
separation
separation
distances
distances
between
between
portable
portable
and mobile
and mobile
RF communications
RF communications
equipment
equipment
The Pulse and
Oximeter
(18710)
is intended
for use
in all
electromagnetic
environment
in not
which
radiated RF
theand
EQUIPMENT
the
EQUIPMENT
or
SYSTEMS
or SYSTEMS
-For
all-For
EQUIPMENT
EQUIPMENT
and SYSTEMS
and SYSTEMS
that arethat
notare
LIFE-SUPPORTING
LIFE-SUPPORTING
Recommended
Recommended
separation
distances
distances
between
between
disturbances are controlled.
The customer
orRFthe
user separation
of the
Pulse
Oximeter
(18710)
can help prevent
portableportable
and mobile
and RF
mobile
communications
communications
equipment
equipment
and Pulse
andOximeter
Pulse Oximeter
(18710)(18710)
electromagnetic
interference
by maintaining
a minimum
distance
between
portable
and
mobile
RF
The Pulse
TheOximeter
Pulse Oximeter
(18710)(18710)
is intended
is intended
for use in
forelectromagnetic
use in electromagnetic
environment
environment
in whichinradiated
which radiated
RF
RF
disturbances
disturbances
are controlled.
are(transmitters)
controlled.
The customer
The customer
or the
user
orPulse
the
of the
user
Pulse
of theOximeter
Pulse
Oximeter
(18710)
can
helpcan
prevent
help prevent
communications
equipment
and
the
Oximeter
(18710)
as(18710)
recommended
below,
electromagnetic
electromagnetic
interference
interference
by maintaining
by maintaining
a minimum
a minimum
distancedistance
betweenbetween
portableportable
and mobile
and RF
mobile RF
according to
the
maximum
output
power
of
the
communications
equipment.
communications
communications
equipment
equipment
(transmitters)
(transmitters)
and theand
Pulse
theOximeter
Pulse Oximeter
(18710)(18710)
as recommended
as recommended
below, below,
according
according
to the maximum
to the maximum
output power
outputofpower
the communications
of the communications
equipment.
equipment.
Rated maximum
outputoutput output
Separation
distance
according
tofrequency
frequency
of(m)
transmitter
(m)
Separation
Separation
distance
distance
according
according
to frequency
to
of transmitter
of transmitter
(m)
Rated maximum
Rated maximum
power ofpower
transmitter
of transmitter
(W)
(W)
power of transmitter
(W)
80 MHz80
to MHz
800 MHz
to 800 MHz d= E7 d=P E7 800PMHz
800
to MHz
2.5
GHz
toto
2.52.5
GHz
d= 3.5
d=P 3.5
800
MHz
GHz
E
E 80PMHz to 800 MHz
1
0.01
0.1
1
10
100
0.01
0.01
0.1
1
0.1
1
10
100
10
100
1
1
0.11670.1167 0.1167
0.36890.3689 0.3689
1.1667 1.1667
1.16673.6893 3.6893
3.689311.666711.6667
11.6667
1
0.2334 0.2334
- 13 -- 13 -
0.2334
0.7378 0.7378
0.7378
2.3334 2.3334
2.3334
7.3786 7.3786
7.3786
23.3334
23.3334
23.3334
16
Fortransmitters
transmittersrated
rated at aamaximum
not
listed
above,
the recommended
sepratation
For
maximumoutput
outputpower
power
not
listed
above,
the recommended
sepratation distance
distance
in metres
(m)estimated
can be estimated
using
the equation
applicable
the frequency
of the
transmitter,
d in
metresd (m)
can be
using the
equation
applicable
to thetofrequency
of the
transmitter,
where P
For
transmitters
rated
at
a
maximum
output
power
not
listed
above,
the
recommended
sepratation
distance
is where
the maximum
output power
ofrating
the transmitter
in wattsin(W)
to thetotransmitter
manufacturer
P is the maximum
outputrating
power
of the transmitter
wattsaccording
(W) according
the transmitter
d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P
NOTE
1 At 80 MHz
800rating
MHz,ofthe
for according
the highertofrequency
rangemanufacturer.
applies.
is manufacturer.
the maximum
outputand
power
theseparation
transmitter distance
in watts (W)
the transmitter
NOTE
These
guidelines
may the
not separation
apply in alldistance
situations.
Electromagnetic
propagation
is affected by
NOTE21 At
80 MHz
and 800 MHz,
for the
higher frequency
range applies.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
absorption
and
re
ection
from
structures,
objects
and
people.
NOTE
2
These
guidelines
may
not
apply
in
all
situations.
Electromagnetic
propagation
is
affected
by
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption
and refland
ection
objects objects
and people.
absorption
refrom
ectionstructures,
from structures,
and people.
ansmitters rated at a maximum output power not listed above, the recommended sepratation distance
etres (m)
be estimated
using
the equation applicable to the frequency of the transmitter, where P
16.can
Symbol
Defi
nitions
16.
Symbol
maximum
output
powerDefinitions
rating of the transmitter in watts (W) according to the transmitter manufacturer.
16. Symbol Definitions
1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Symbol
Symbol
2 These
guidelines may not
apply De
in allnition
situations. Electromagnetic
propagation is affected by Denition
Symbol
Definition
SymbolDefinition
nition objects and people.Symbol
Denition
Symbol
absorption
and reection from De
structures,
Low
power indication
No for
continuous
monitoring
Theequipment
equipment type
type is
BF
The
is BF
The equipment type is BF
Symbol Definitions
Refertotouser
usermanual
manual
Refer
DeRefer
nition
to user manual
before
application
before
application
before
application
mbol
pO2%
Low power indication
Denition
No
for continuous
monitoring
Low
indication
No
forpower
continuous
monitoring
Symbol
Low power indication
SN SN
Serial
No.
SerialSerial
No. No.
The equipment type is BF
Hemoglobin
saturation
Hemoglobin
saturation
Hemoglobin
saturation
SpO2%
2%
SpO
Refer to user manual
pulserate
rate
(bpm)
pulse
(bpm)
Pulse
rate
(bpm)
PRbpm
bpm application
PR
before
Hemoglobin saturation
pulse rate (bpm)
No for continuous
of Manufacture
Date Date
ofmonitoring
Manufacture
Date of Manufacture
SN
- 14
- - 14
Serial No.
17
2 Year Limited Warranty
Your Drive brand product is warranted to be free of defects in materials and workmanship
for two years of the original consumer purchaser.
This device was built to exacting standards and carefully inspected prior to shipment. This 2
year Limited Warranty is an expression of our confi dence in the materials and workmanship
of our products and our assurance to the consumer of years of dependable service.
In the event of a defect covered by this warranty, we will, at our option, replace the device.
This warranty does not cover device failure due to owner misuse or negligence, or normal
wear and tear.
If you have a question about your Drive device or this warranty, please contact an
authorized Drive dealer.
18
Français
Drive Health-Ox
Oxymètre de pouls digital
19
1. Principe de fonctionnement
Cet oxymètre permet d’affi cher le taux de saturation d’oxygène fonctionnel. Le principe de
l’oxymètre est le suivant : les calculs sont effectués à l’aide d’une formule empirique basée
sur la loi de Lambert Beer portant sur les caractéristiques d’absorption de spectre de
l’hémoglobine (R-Hb) et de l’oxyhémoglobine (O2-Hb) dans la gamme visible et proche
infrarouge. Le principe de fonctionnement de l’appareil repose sur la technologie de l’analyse
photoélectrique de l’oxyhémoglobine, et e le mesure de leur absorption par le fl ux pulsatile du
sang. Deux faisceaux de différentes longueurs d’onde (660 nm visible, 880 nm infrarouge) dirigés sur un ongle humain et lus par un capteur situé dans une pincette dans laquelle on insère
un doigt. Le résidu spectral peut être lu par une cellule photosensible, et le résultat du calcul
est affi ché à l’aide de deux groupes de segments sur un écran ACL après traitement par
des circuits électroniques et un microprocesseur.
2. Précautions pour l’utilisation
• L’appareil 18710 peut être affecté par l’utilisation d’un appareil électrochirurgical (ESU).
• L’appareil 18710 doit pouvoir mesurer le pouls correctement afi n de calculer une valeur
exacte de SpO2. Assurez-vous que la mesure du pouls est correcte avant de vous fi er
aux mesures de SpO2.
• N’utilisez pas l’appareil 18710 dans un environnement d’IRM ou de TD
• N’utilisez pas l’appareil 18710 lorsqu’un mécanisme d’alarme est requis. Cet appareil ne
comporte pas d’alarme. and blood oxygen levels while exercising.
20
• Risque d’explosion : n’utilisez pas l’appareil 18710 dans une atmosphère explosive.
• Les 18710 sont seulement pour l’utilisation non-medicale pour les gens en bonne sante
controller leurs niveaus d’oxygene de snag et de pouls en exercant.
• Examinez le site d’application de l’oxymètre fréquemment afi n d’évaluer la position de
l’appareil, la circulation sanguine et l’état de l’épiderme du utilisateur.
• Lisez attentivement le guide avant d’utiliser l’appareil.
• L’appareil 18710 ne comporte pas de système d’alarme. Il n’est pas prévu pour une
surveillance continue, comme en témoigne le symbole.
• Une utilisation prolongée ou l’état du utilisateur peut exiger que l’appareil soit déplacé
régulièrement. Pour la lecture par sonde d’oxymétrie, il est conseillé de changer de doigt
toutes les 2 heures.
3. Facteurs pouvant induire des erreurs de mesure
• • Ne stérilisez pas l’appareil à l’autoclave, à l’aide d’oxyéthylène ou par immersion dans un
liquide, car ceci pourrait fausser les résultats. L’appareil ne doit pas être stérilisé.
• Un taux élevé d’hémoglobine dysfonctionnelle (comme la carboxyhémoglobine ou la
méthémoglobine).
• Des colorants vasculaires comme le vert d’indocyanine ou le bleu de méthylène.
• La mesure de SpO2 peut être faussée en présence d’un éclairage ambiant intense
comme la lumière directe du soleil. Protegez le detecteur area de la lumiere du soleil
directe ou de l’eclairage en sale.
• Des mouvements excessifs de la part du utilisateur.
• Des interférences à haute fréquence provenant d’un appareil électrochirurgical ou d’un
défi brillateur.
• Un pouls veineux.
• L’installation de l’appareil sur un doigt avec présence d’un brassard de
sphygmomanomètre, un cathéter artériel ou intravasculaire.
• Le utilisateur souffre d’hypotension, de vasoconstriction, d’anémie sévère ou
d’hypothermie.
• Le utilisateur est en arrêt cardiaque ou en état de choc.
• Le vernis à ongles et les faux ongles peuvent causer des erreurs de lecture de SpO2.
• Respectez les lois et règlements concernant de dépôt aux ordures et le recyclage de
l’appareil et de ses composants, incluant les piles.
4. Spécifi cations techniques
Afficheur: DEO (LED)
- Plage de mesure SpO2 : 0 % à 99 %,
précision : ±2%; ≤70% pas de défi nition.
- Plage de mesure du pouls : 30 à 250 bpm,
précision : ±2 bpm ou ±2 % pour la fréquence du pouls (prendre la plus grande des deux lectures).
Alimentation: Deux piles alcalines de type AAA 1,5 V
Faible consommation: Moins de 25 mA
Précision des mesures: Précision SpO2 :±2% ; ≤70% pas de défi nition
Aucune défi nition inférieure à 70 %
Pouls : ±2 bpm ou ±2 % pour la fréquence du pouls (prendre la plus grande des deux lectures).
21
22
L’appareil se met automatiquement hors tension s’il ne reçoit aucun signal pendant
5 secondes.
Dimension: Longueur : 56mm~62mm;
largeur : 32mm~38mm ;
Poids : 45g~60g (incluant les deux piles AAA)
Environment: Utilisation: 50°F ~ 104°F / 10°C ~ 40°C
Entreposage: -40°F ~ 140°F / -40°C ~ 60°C
5. Caractéristiques de l’appareil
5.1 L’appareil est pratique et facile à utiliser.
5.2 L’appareil est petit et léger (50 g incluant les piles) et facile à transporter.
5.3 Il consomme peu d’énergie : les deux piles AAA originales permettent une utilisation
continue de 30 heures.
5.4 L’affi cheur comporte un avertissement de pile faible qui apparaît lorsque le voltage est
bas au point de compromettre la lecture de l’oxymètre.
5.5 L’appareil se met automatiquement hors tension s’il ne reçoit aucun signal pendant plus de 5 secondes.
23
6. Utilisation préconisée
Utilisation préconisée:
L’oxymètre de pouls digital 18710 permet d’effectuer des lectures momentanées non
invasives du taux de saturation de l’hémoglobine artérielle (SpO2) et du pouls d’un enfant
ou d’un adulte les utilisateurs a maison ou en exercant.
Non prévu pour une utilisation continue.
L’appareil 18710 ne requiert aucun calibrage ou entretien périodique autre que le
remplacement des piles.
7. Instructions pour l’utilisation de l’appareil
7.1 Insérez deux piles AAA dans le compartiment et reposez le couvercle.
7.2 Ouvrez la pince comme dans l’illustration qui suit.
7.3 Placez un doigt dans le compartiment caoutchouté de l’oxymètre (il vaut mieux insérer
le doigt complètement avant de refermer la pince.
7.4 Appuyez une fois sur l’interrupteur qui se situe sur la face supérieure.
7.5 Il faut que votre doigt ne tremble pas et il est recommandé de ne pas se déplacer
pendant la lecture.
7.6 Relevez les données sur l’affi cheur de l’appareil.
7.7 1 mode d’affi chage.
24
Mettez l’oxymètre sous tension. Chaque fois que vous appuyez sur l’interrupteur,
l’oxymètre bascule vers le prochain mode d’affi chage. Il y a deux modes d’affi chage.
the power switch, the Oximeter will
ur
h
se
Le rétroéclairage est réglé au niveau 4 par défaut. Votre ongle doit se trouver du côté de
l’affi cheur lorsque vous insérez votre doigt dans l’oxymètre.
8. Description du panneau de commande Pa
Un diagramme à barreSpO
la qualité
du pouls. La barre comporte dix niveaux.
2
Une qualité de lecture de pouls est jugée inadéquate si la barre indique le niveau
Pulse Column
deux ou trois.
PR
Power Switch
25
9. Accessoires
Product Accessories
9.1 Une dragonne
One 9.2
Lanyard
Deux piles
Two 9.3
batteries
Un guide d’utilisation
One 9.4
instruction
manual
Un étui protecteur
One protective boot
10. Installation
des piles
. Battery
Installations
10.1two
Insérez
deux piles
de battery
type AAAcassette
dans le compartiment
en respectant la polarité.
Put the
AAAlesbatteries
into
in correct polarities.
10.2
couvercle
horizontalement,
dans
le sens
des fl as
èches,
comme indiqué :
Push
thePoussez
batterylecover
horizontally
along the
arrow
shown
below:
es: Nota:
polarité desmust
piles doit
respectée,
au risque
tery La
polarities
be être
correctly
installed.
erwise,
damage might
be caused to device.
d’endommager
l’appareil.
Placez
piles dans
le bon ordre,
au risque
ase put
or les
remove
batteries
in right
order, or is
d’endommager
les supports
de piles.
y to damage
the device
bracket.
Veuillez retirer les piles si l’oxymètre n’est pas utilisé
se remove
the Oximeter will not be
pendantthe
unebattery
périodeifprolongée.
d for a long time.
11. Installation de la dragonne
.Hang Lace Installations
11.1 Passez la partie fi ne de la dragonne dans le trou.
1 Thread
of plus
the hang
the
hanging
hole.
11.2 thinner
Passez laend
partie
grosselace
de lathrough
dragonne
dans
l’anneau
constitué par la partie fi ne
2 Thread
thicker
et tirez. end of the lace through the threaded end before pulling it tightly.
26
12. Entretien et remisage
12.1 Remplacez les piles promptement lorsque l’indicateur de pile faible apparaît.
12.2 Nettoyez les surfaces de l’oxymètre avant de l’utiliser.
12.3 Retirez les piles du compartiment si l’oxymètre n’est pas utilisé pendant une période
prolongée
12.4 Il est préférable de conserver l’appareil à une température ambiante entre
-40 °C et 60 °C (-40 °F à 140 °F) et une humidité ambiante entre ≤95%.
Il est préférable de conserver l’appareil dans un environnement sec. Un environnement
humide peut endommager l’appareil ou réduire sa durée de vie.
Nettoyage de l’appareil 18710
Nettoyez l’intérieur de l’oxymètre à l’aide d’un chiffon doux mouillé d’alcool isopropylique à
70 %. Nettoyez le doigt qui servira au test à l’aide d’alcool avant et après chaque test.
Ne vaporisez pas et ne versez pas de liquide sur l’oxymètre. Ne laissez aucun liquide
pénétrer par les ouvertures de l’oxymètre. Laissez sécher l’oxymètre parfaitement avant de
le réutiliser.
13. Calibration de l’appareil 18710
• Les appareils de tests fonctionnels ne peuvent pas être utilisés pour évaluer la précision
de l’oxymètre.
• La méthode utilisée pour évaluer la précision des mesures de SpO2 est le test clinique.
Les données de l’oxymètre concernant taux de saturation en oxygène de l’hémoglobine
artérielle sont comparables aux données obtenus par échantillonnage sanguin et traitées
à l’aide d’un CO-oxymètre.
27
14. Dépannage
Problème
Cause possible
Solution
% SpO2 ou le pouls
n’est pas affi ché
normalement
1.Le doigt n’est pas placé correctement
2.Le SpO2 du utilisateur est trop faible
pour être mesuré
1.Replacez le doigt
2.L’éclairage ambiant est trop fort
3.Effectuez d’autres lectures pour
vous assurer que l’appareil fonctionne
bien. Consultez un professionnel de
la santé rapidement afi n d’obtenir un
diagnostic formel
L’affi chage du %
SpO2 ou du pouls
est instable
1.Le doigt n’est pas inséré assez profondément
2.Mouvements excessifs
1. Repositionnez le doigt
2. Soyez plus calme
L’affi cheur ne
s’allume pas
1.Piles absentes ou trop faibles
2.Piles mal insérées
3.Appareil endommagé
1. Remplacez les piles
2. Réinstallez les piles
3. Communiquez avec le service à la
clientèle
L’affi cheur s’éteint
soudainement
1.L’appareil se met hors tension s’il ne
détecte aucun signal pendant 5 secondes
2.Les piles sont trop faibles
1. Normal
2. Remplacez les piles
28
15. Déclaration
Émissions électromagnétiques – recommandations et déclarations du fabricant
Pour tous les ÉQUIPEMENTS et SYSTÈMES
Émissions électromagnétiques – recommandations et déclarations du fabricant
Les recommandations et déclarations du fabricant concernant l’environnement électromagnétique apparaissent
dans ce tableau. Le client ou l’utilisateur de l’oxymètre de pouls digital (18710) doit s’assurer qu’il est utilisé dans un
tel environnement.
Test d’émissions
Conformité
Recommandations sur l’environnement électromagnétique
Émissions RF CISPR 11
Groupe 1
L’oxymètre de pouls (18710) ne produit que de très faiblesémissions RF et ne nuira à aucun équipement à proximité.
Émissions RF CISPR 11
Classe B
Émissions harmoniques
IEC 61000-3-2
Sans objet
L’oxymètre de pouls (18710) Cet appareil est prévu pour
une utilisation dans tous les types d’établissements, y
compris les établissements domestiques et ceux branchés
directement au réseau public d’alimentation électrique à
basse tension
Fluctuations de tension /
papillotements
IEC 61000-3-2
Sans objet
29
Immunité électromagnétique – recommandations et déclarations du fabricant
Pour tous les ÉQUIPEMENTS et SYSTÈMES
Immunité électromagnétique – recommandations et déclarations du fabricant
Les recommandations et déclarations du fabricant concernant l’environnement électromagnétique apparaissent
dans ce tableau. Le client ou l’utilisateur de l’oxymètre de pouls digital (18710) doit s’assurer qu’il est utilisé dans un
tel environnement.
Recommandations – environnement
Test d’immunité
Niveau de test
Conformité
électromagnétique
IEC 60601
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
+/- 6kV contact
+/- 8kV air
Le plancher doit être recouvert de bois, de
béton ou de céramique. Si le plancher est
recouvert de matériel synthétique, l’humidité
relative doit être d’au moins 30 %.
Champs magnétiques à
la fréquence du
réseau
(50/60 Hz)
IEC61000-4-8
3A/m
3A/m
Les champs magnétiques du réseau de
distribution doivent correspondre à ceux d’un
environnement hospitalier ou commercial
typique.
30
Immunité électromagnétique – recommandations et déclarations du fabricant
Pour tous les ÉQUIPEMENTS et SYSTÈMES non reliés au MAINTIEN DE LA VIE
Immunité électromagnétique – recommandations et déclarations du fabricant
Les recommandations et déclarations du fabricant concernant l’environnement électromagnétique apparaissent dans ce
Guidance and Manufacture’s declaration – electromagnetic immunitytableau. Le client ou l’utilisateur
deand
poulsSYSTEMS
digital (18710)
doit
s’assurer
qu’il est utilisé dans un tel environnement.
Forde
alll’oxymètre
EQUIPMENT
that are
not
LIFE-SUPPORTING
Guidance and Manufacture’s declaration – electromagnetic immunityFor all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
and Manufacture’s declaration - electromagnetic immunity
Test
Niveau de Guidance
Conformité
Guidance and Manufacture’s declaration
– electromagnetic
environment
specied below.
The customer
or
Conformité
Electromagnetic
– guidance
Guidance
andEnvironment
Manufacture’s
declaration
- electromagnetic
immunity
user
the Pulse Oximeter (18710) should assure that it is used in such an environment.
d’immunitéthetest
IECof60601
Guidance and Manufacture’s declaration – electromagnetic environment specied below. Th
the user of the Pulse Oximeter (18710) should assure that it is used in such an environment
Immunity IEC 60601 ComplianceLes équipements
portables
et
mobiles
à
RF
doivent
être
utilisés
à
une
Electromagnetic
Environment
–
guidance
Level
test level
test
Compliance
IECde
60601
Immunity
certaine
distance
toutes
les composantes
de should
l’oxymètre
de pouls
digital – guid
RF par
3 V/m 80
3 V/m
Electromagnetic
Environment
Portable
RF
communications
equipment
be
Level
test level
test and mobile
3 V/m
used no
to any
of the
Oximeter
(18710),est
including
Radiated
(18710),
y closer
compris
lespart
câbles.
LaPulse
distance
minimale
calculée
à l’aide de equipmen
mobile
RF communications
rayMHz
80
MHz
to
cables,
than
the
recommended
separationPortable
distanceand
calculated
RF
3 V/m
3 V/m
used
no
closer
to
any
part
of
the
Pulse
Oximeter (18
Radiated
l’équation
correspondant
à
la
fréquence
du
transmetteur.
2.5
GHz
from the equation
to the frequency of the transmitter.
80 applicable
MHz to
onnement IEC
à 2,5 GHz
cables, than the recommended separation distance
RF
3 V/m
Recommended
separation
61000-4-3
Distance
2.5
GHz : distance
from the equation applicable to the frequency of the
IEC recommandée
IEC
d=
MHz
to 800
MHz
P 8080
61000-4-3
MHz
à 800
MHz Recommended separation distance
d=
P 80 MHz to 800 MHz
61000-4-3
800
MHz
à 2,5
GHz
d=
MHz
to 2.5
GHz
P 800
OùWhere
P est la
puissance
de
sortie
maximaled=du
transmetteur,
en watts (W)
800 MHz
P is the maximum output power rating
of the Ptransmitter
in to 2.5 GHz
selon
le(W)
fabricant
dutotransmetteur
d est
la distance
en
watts
according
the transmitteret
manufacturer
and d isrecommandée
the
Where
P is the maximum output power rating of the
recommended
separation
distance
in
metres
(m).
mètres
(m).
(W) according
Field strengths from xed RF transmitters, watts
as determined
by anto the transmitter manufacturer
recommended
separation
distance
in metres (m).
a
site survey
, should
be less than theRF
compliance
La electromagnetic
force des champs
émis par
les transmetteurs
fi xes, telle
Field strengths from xed RF transmitters, as determ
in each frequency range. b
electromagnetic
quelevel
mesurée
sur leoccur
siteina,the
doitvicinity
être inférieure
aumarked
niveausite
desurvey a, should be less than t
Interference
may
of equipment
with
b
level
in
each
frequency
range.
following symbol:
conformité
dans chaque gamme de fréquenceb.
Interference may occur in the vicinity of equipment m
following
symbol:immédiats
interférences
peuvent
survenir dans
les environs
NOTE 1: At 80 MHz and 800 MHz, theDes
higher
frequency range
applies.
NOTE 2: These guidelines may not apply
in
all
situations,
Electromagnetic
propagation is affected by
des appareils
ce800
symbole
NOTE 1: Ataffi
80 chant
MHz and
MHz, the higher frequency range applies.
3.5
E1
7
E1
3.5
E1
7
E1
absorption and reection structures, objects and people.
NOTE 2: These guidelines may not apply in all situations, Electromagnetic propagation is aff
NOTA 1: À 80 MHz et 800 MHz, on doit considérer la plus
gamme
de fréquences.
and reection
structures, objects and people.
- absorption
12haute
NOTE 2: Ces recommandations peuvent ne pas s’appliquer à toutes les situations. La propagation
des champs
- 12 électromagnétiques est affectée par l’absorption et la réfl exion des objets, des structures et des individus présents.
31
a La force des champs émis par les transmetteurs fi xes comme les antennes émettrices des fournisseurs de
services pour les téléphones cellulaires et sans fi l et les appareils radio, radio amateur, AM, FM et de télédiffusion
ne peuvent être prédits sur une base théorique avec exactitude. L’environnement électromagnétique imputable
aux transmetteurs RF fi xes ne peut donc être mesuré que sur le site. Si les champs magnétiques mesurés dans
l’environnement d’utilisation de l’oxymètre de pouls digital (18710) sont supérieurs aux niveaux de conformité
mentionnés plus haut, on doit observer le fonctionnement de l’appareil pour déterminer s’il est affecté ou non par
la situation. Si on observe une performance anormale, on devra prendre des dispositions particulières comme le
changement d’orientation ou d’emplacement de l’oxymètre de pouls digital (18710).
astrengths
b Au delà dea laField
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150transmitters,
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to 80asMHz,
labase
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des
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être moins
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xed
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such
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station
station
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for
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telephones
telephones
and
and de 3 V/m
land mobile
land radios,
mobile amateur
radios, amateur
radio, AM
radio,
andAM
FMand
radio
FM
broadcast
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and TV and
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cannot be
cannot
predicted
be predicted
t
t
heoretically
heoretically
with entre
accuracy.
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To assess
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xed
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anÉQUIPEMENTS
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ou SYSTÈMES
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etbeSYSTÈMES
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If abnormal
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observed,
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additional
additional
measurements
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reorienting
as reorienting
of the relocating
of the relocating
the Pulse
the Pulse
Distance recommandée
entre
les équipements de communication à RF portables ou mobiles
Oximeter
Oximeter
(18710).
(18710).
b Over
btheOver
et l’oxymètre
de pouls
(18710)
frequency
the frequency
range 150
range
kHz150
to 80
kHz
MHz,
to 80elds
MHz,strengths
elds strengths
should be
should
less be
than
less
3 V/m
than 3 V/m
Recommended
Recommended
separation
separation
distances
distances
between
between
portable
portable
and mobile
and mobile
RF communications
RF communications
equipment
equipment
L’oxymètreand
de pouls
digital
(18710)
estorprévu
pourallune
utilisation
dansSYSTEMS
un
environnement
dans lequel les
theand
EQUIPMENT
the EQUIPMENT
or SYSTEMS
SYSTEMS
-For
-For
EQUIPMENT
all EQUIPMENT
and
and
SYSTEMS
that arethat
notélectromagnétique
are
LIFE-SUPPORTING
not LIFE-SUPPORTING
Recommended
Recommended
separation
distances
distances
betweenbetween
perturbations par rayonnement
RF sontand
contrôlées.
Leseparation
propriétaire
ou
l’utilisateur
de
l’oxymètre
de pouls digital (18710) peut
portableportable
and mobile
RF
mobile
communications
RF communications
equipment
equipment
and Pulse
andOximeter
Pulse Oximeter
(18710)(18710)
aider à prévenir
les The
interférences
électromagnétiques
enformaintenant
uneenvironment
distance
minimale
entre
lesRFéquipements
de comThe Pulse
Oximeter
Pulse Oximeter
(18710)(18710)
is intended
is intended
for use in
electromagnetic
use in electromagnetic
environment
in whichinradiated
which radiated
RF
disturbances
disturbances
are controlled.
The customer
The customer
oretthe
user
or the
of the
user
of
theOximeter
Pulse
Oximeter
(18710)
can
helpcan
prevent
help
prevent
munication portable
/ mobiles
àareRFcontrolled.
(transmetteurs)
l’oxymètre
dePulse
pouls
digital
(18710),(18710)
en suivant
les recommandations
du
electromagnetic
electromagnetic
interference
interference
by maintaining
by maintaining
a minimum
a minimum
distancedistance
betweenbetween
portableportable
and mobile
and RF
mobile RF
tableau suivant,
basé
sur
la
puissance
de
sortie
maximale
des
équipements
de
communication
communications
communications
equipment
equipment
(transmitters)
(transmitters)
and theand
Pulse
theOximeter
Pulse Oximeter
(18710)(18710)
as recommended
as recommended
below, below,
according
according
to the maximum
to the maximum
output power
outputofpower
the communications
of the communications
equipment.
equipment.
Puissance de
sortie
Distance
recommandée
enfrequency
fonction
laoffréquence
du transSeparation
Separation
distance
distance
according
according
to
to frequency
of de
transmitter
transmitter
(m)
(m)
Rated maximum
Rated maximum
output output
power ofpower
transmitter
of transmitter
(W)
(W)
Nominale du
80 MHz80
to MHz
800 MHz
to 800 MHz d= E7 d=P E7 800PMHz
800
to MHz
2.5
GHz
toto
2.52.5
GHz
d= 3.5
d=P 3.5
800
MHz
GHz
E
E 80PMHz to 800 MHz
Transmetteur (W)
1
0.01
0.1
1
10
100
0.01
0.01
0.1
1
0.1
1
10
100
10
100
1
1
0.11670.1167 0.1167
0.36890.3689 0.3689
1.1667 1.1667
1.16673.6893 3.6893
3.689311.666711.6667
11.6667
1
0.2334 0.2334
- 13 -- 13 -
0.2334
0.7378 0.7378
0.7378
2.3334 2.3334
2.3334
7.3786 7.3786
7.3786
23.3334
23.3334
23.3334
32
Pour les transmetteurs dont la puissance maximale n’apparaît pas dans le tableau, la distance de
séparation recommandée d en mètres (m) peut être calculée à l’aide de la formule correspondant à
la fréquence
du rated
transmetteur,
où P est la
puissance
maximale
duabove,
transmetteur
en Watts (W) selon
le
For
transmitters
at a maximum
output
power
not listed
the recommended
sepratation
distance
d in
metresdu
(m)
can be estimated using the equation applicable to the frequency of the transmitter, where P
fabricant
transmetteur.
Forthe
transmitters
rated
at apower
maximum
output
power
not listed
above,(W)
the according
recommended
sepratation
distance
is
maximum
output
rating
of
the
transmitter
in
watts
to
the
transmitter
manufacture
NOTA
1 : À(m)
80 MHz
et 800
MHz, lausing
distance
séparation
de la plus
haute
gammeofdethe
fréquence
doitwhere
être P
d in
metres
can be
estimated
the de
equation
applicable
to the
frequency
transmitter,
NOTE
1 At 80 MHz
800rating
MHz,ofthe
for according
the highertofrequency
rangemanufacturer.
applies.
is utilisée.
the maximum
outputand
power
theseparation
transmitter distance
in watts (W)
the transmitter
NOTE
22 :These
guidelines maypeuvent
not apply
in
alls’appliquer
situations.à toutes
Electromagnetic
propagation
is affected
by
NOTA
Ces
recommandations
ne
pas
les
situations.
La
propagation
des
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
absorption
and re
ection
fromin
structures,
objects
people.
champs
électromagnétiques
est
affectée
par
et la and
réfl exion
despropagation
objets, des structures
NOTE
2 These
guidelines
may
not
apply
alll’absorption
situations.
Electromagnetic
is affectedet
bydes
absorption
individus
présents. and reection from structures, objects and people.
ansmitters rated at a maximum output power not listed above, the recommended sepratation distance
metres (m)
can
be
estimated
using
the equation applicable to the frequency of the transmitter, where P
16.output
Symbol
Defi
nitions
16.
Symbol
maximum
powerDefinitions
rating of the transmitter in watts (W) according to the transmitter manufacturer.
16. Symbol Definitions
E 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Symbol
Symbol
E 2 These
guidelines may not
apply De
in allnition
situations. Electromagnetic
propagation is affected by Denition
Symbol
Definition
SymbolDefinition
nition objects and people.Symbol
Denition
Symbol
absorption
and reection from De
structures,
Low power
indication
Indicateur
de pile
faible
The equipment
type is
Équipement
de type
BFBF
The equipment type is BF
Symbol Definitions
Non prévu pour une surveil-
Refer to user
manual
Consultez
le Guide
avantSymbol
DeRefer
nition
to user manual
before
application
l’utilisation
before
application
mbol
pO2%
Low power indication
The equipment type is BF
Hemoglobin
saturation
Saturation
de
l’hémoglobine
Hemoglobin
saturation
SpO2%
2%
SpO
Refer to user manual
pulserate
rate
(bpm)
pulse
(bpm)
Rythme
cardiaque
PRbpm
bpm application
PR
before
(battements par minute)
Hemoglobin saturation
Denition
No
for continuous
monitoring
lance
continue
No
for continuous
monitoring
Low power indication
Numéro
série
Serial
SN SN
Serial
No. deNo.
No for continuous
monitoring
of Manufacture
Date
of
Manufacture
DateDate
de
fabrication
SN
Serial No.
33
Garantie limitée de deux ans
Votre produit de marque Drive est garanti contre les défauts de matériel et de maind’oeuvre pour deux années à compter de l’achat par le client original.
Cet appareil a été fabriqué selon des normes de qualité strictes et a été inspecté avant
l’expédition. Cette garantie limitée de deux ans témoigne de la confi ance que nous avons
en la main-d’oeuvre et aux matériaux utilisés dans la fabrication de nos produits et notre
assurance qu’il vous donnera des années de services fi ables.
Si l’appareil présente un défaut couvert par cette garantie, nous remplacerons l’appareil à
notre seule discrétion. Cette garantie ne couvre pas les défaillances dues à un usage abusif
ou à la négligence du propriétaire, ni à l’usure normale.
Si vous avez des questions concernant votre appareil Drive ou cette garantie, veuillez communiquer avec votre revendeur Drive.
34
Español
Drive Health-Ox
Oxímetro de pulso para dedo
35
1. Principio de medición
El oxímetro está calibrado para mostrar la saturación funcional del oxígeno. El principio bajo el
que funciona el oxímetro es el siguiente: Se establece una formula de proceso de datos usando la
ley de Lambert Beer de acuerdo a las características del espectro de absorción de hemoglobina
reductiva (R Hb) y oxihemoglobina (O2 Hb) en zonas brillantes y zonas cercanas al infrarrojo. El
principio de operación del instrumento es la tecnología de inspección fotoeléctrica de oxihemoglobina, el cual es adoptado de acuerdo a la tecnología de capacidad de escaneo y grabación de
pulso, para que así, dos rayos de luz de diferente longitud de onda (brillo de 660nm y luz cercana
al infrarrojo de 880 nm) se enfoquen sobre la punta de la uña por medio de una abrazadera tipo
sensor ajustada al dedo. Posteriormente se mide una señal que proviene de un elemento fotosensible, esta información aparecerá en dos grupos de LEDs (diodos emisores de luz) por medio de
un proceso en circuitos electrónicos y un microprocesador.
2. Precauciones de uso
• La operación del 18710 puede verse afectada por el uso de una unidad electroquirúrgica (ESU).
• El 18710 debe ser capaz de medir el pulso adecuadamente para obtener una medición
exacta de SpO2. Verifi que que nada esté entorpeciendo la medición del pulso antes de
obtener la medición de SpO2.
• No utilice el 18710 en un área de Resonancia Magnética o Tomografía Computarizada
• No utilice el 18710 bajo circunstancias en donde se necesiten alarmas. El dispositivo no
tiene alarmas.
• Peligro de explosión: No utilice el 18710 bajo una atmósfera con riesgo de explosión.
36
• El 18710 es solamente utilizado por personas saludables sun ningun uso medico
sirve como monitor del pulso y los nineles de oxigeno de la sangre mientras se hace
ejercicio.
• Verifi que frecuentemente el sitio de la aplicación del sensor del oxímetro para determinar
que el sensor esté posicionado adecuadamente y para detectar la circulación y
sensibilidad de la piel del usuario.
• Lea cuidadosamente el manual antes de su uso.
• El 18710 no tienen alarmas SpO2, no está diseñado para monitoreo continuo, como lo
indica el símbolo.
• El monitoreo prolongado de la condición del usuario puede requerir que cambie la
ubicación del sensor periódicamente. Se recomienda que no se aplique el sensor al mismo dedo por más de 2 horas.
3. Inexactitud en las mediciones pueden ser ocasionadas por
• No esterilizar el dispositivo por autoclave, por esterilización de óxido de etileno o
sumergiendo el sensor en líquidos que pueden ocasionar inexactitud en las lecturas.
Este dispositivo no está diseñado para esterilización.
• Niveles importantes de hemoglobina disfuncional (como carboxihemoglobina o
metahemoglobina)
• Colorantes intravasculares como verde de indocianina o azul de metileno
• Las mediciones de SpO2 pueden afectarse adversamente en presencia de fuerte luz
ambiental. Cubra la area del sensor de la luz directa del sol o de la luz interior.
• Movimiento excesivo del usuario
37
• Interferencia electro-quirúrgica de alta frecuencia y desfi briladores
• Pulsaciones venosas
• Colocación de un sensor sobre una extremidad con un esfi gmomanómetro, catéter
arterial o línea intravascular
• El usuario tiene hipertensión, vasoconstricción grave, anemia grave o hipotermia
• El usuario está en paro cardiaco o en shock
• Unas pintadas o falsas puede proporcionar lecturas inexactas de SpO2.
• Siga las ordenanzas locales y las instrucciones de reciclado para deshacerse o reciclar
el dispositivo y sus componentes, incluyendo las baterías.
4. Especifi caciones técnicas
Tipo de pantalla: Pantalla LED
Rango de medición de SpO2: 0%-99%
Exactitud : ±2%; ≤70% ninguna defi nición
Rango de medición de rango de pulso: 30 – 250 bpm,
Exactitud : ±2 bpm o ±2% (seleccione el mayor) para la frecuencia de pulso.
Energía requerida: Dos baterías alcalinas AAA de 1.5V
Consumo bajo: Menos de 25mA
Exactitud de medición: SpO2 Exactitud: ±2%; ≤70% ninguna defi nición
No defi nición de menos de 70%
Frecuencia de pulso : ±2 bpm o ±2% (seleccione el mayor) para la frecuencia de pulso.
38
El producto se apagará automáticamente cuando el producto no tenga ninguna señal
por más de 5 segundos.
Dimensión de: Length: 56mm~62mm,
Width: 32mm~38mm ;
Weight: 45g~60g (incluyendo dos baterías AAA)
Requisitos ambientales: Temperatura de operación: 50°F ~ 104°F / 10°C ~ 40°C
Temperatura de almacenaje: -40°F ~ 140°F / -40°C ~ 60°C
5. Propiedades del producto
5.1 La operación del producto es simple y práctica
5.2 El producto es pequeño, ligero (peso total es de alrededor de 50g incluyendo baterías)
y es práctico de llevar
5.3 El consume de energía es bajo y las dos baterías AAA incluidas pueden operar
continuamente por 30 horas.
5.4 La advertencia de bajo voltaje aparecerá visualmente en la pantalla cuando el voltaje
de la batería sea tan bajo que pueda infl uenciar la operación normal del Oxímetro.
5.5 El producto se apagará automáticamente cuando el producto no tiene ninguna señal
por más de 5 segundos.
39
6. Usos previstos del producto
Usos previstos:
Fingertip Pulse Oximeter 18710 is a portable non-invasive, spot-check, oxygen saturation
of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric users at home or
while exercising.Not for continuously monitoring.
The 18710 requires no routine calibration or maintenance other than replacement of
batteries.
7. Operation Instructions
7.1 Instale las dos baterías AAA dentro del compartimiento para baterías antes de colocar
la cubierta.
7.2 Abra la pinza como se muestra en la fi gura de abajo
7.3 Introduzca uno de los dedos dentro del hoyo de plástico del Oxímetro (es mejor
cuando coloca el dedo hasta adentro) antes de soltar la pinza.
7.4 Presione el botón del panel frontal una vez.
7.5 Asegúrese que su dedo no tiemble cuando el Oxímetro está trabajando. Su cuerpo no
debe estar en movimiento.
7.6 Lea el dato correspondiente de la pantalla.
7.7 1 modo de pantalla.
40
Encienda el oxímetro. Cada vez que presiona el botón de encendido, el oxímetro se
cambiará a otro modo de pantalla, existen 2 modos de pantalla.
the power switch, the Oximeter will
ur
h
se
Cuando coloca su dedo dentro del Oxímetro, la uña debe estar haciaarriba.
8. Descripción breve del panel frontal
Las señales de calidad de pulso del usuario se indican por medio de una gráfi ca
de barras. La barra está
graduada
con 10 niveles, si la fuerza es de dos a tres
SpO
2
niveles entonces la frecuencia de señal es inadecuada.
Pulse Column
PR
Power Switch
41
9. Accesorios del producto
9.1 Un cordón
9. Product
Accessories
9.2 Dos baterías
1
2
3
4
One
9.3Lanyard
Un manual de instrucciones
9.4batteries
Una bolsa protectora
Two
One instruction manual
10.
Instalación de baterías
One protective boot
10.1 Coloque las dos baterías AAA dentro del compartimiento de baterías en las
10. Battery
Installations
polaridades
correctas.
10.2
Presione
la cubierta
deinto
la batería
horizontalmente
a lo largo
de la fl echa como se
0.1 Put
the
two AAA
batteries
battery
cassette in correct
polarities.
indica
a continuación:
0.2 Push
the
battery
cover horizontally along the arrow shown as below:
otes:Notas:
Laspolarities
polaridades de
la batería
deben instalarsecorrectamente.
attery
must
be correctly
installed.
De nodamage
ser así, semight
puedebe
dañar
el dispositivo.
therwise,
caused
to device.
Por favor, coloque o retire las baterías en el orden
ease put or remove batteries in right order, or is
de no ser así, se puede dañar el soporte del
ely tocorrecto,
damage
the device bracket.
dispositivo.
easePor
remove
the battery
if the
Oximeter
willelnot
be
favor, retire
las baterías
si no
va a utilizar
Oxímetro
sed for
long
time.de tiempo prolongado.
pora un
periodo
11.Hang
Lace
Installations
11.Hang
Lace
Installations
11.1 Inserte el extreme más delgado del cordón a través del hoyo para colgarse.
1.1 Thread
thinner end of the hang lace through the hanging hole.
11.2 Inserte el extremo del cordón más grueso a través del otro extremo antes de jalar y apretar.
1.2 Thread thicker end of the lace through the threaded end before pulling it tightly.
12. Mantenimiento y almacenaje
12.1 Reemplace las baterías cuando se encienda el indicador de bajo voltaje.
12.2 Limpie la superfi cie del Oxímetro antes de usarlo.
12.3 Quite las baterías del compartimiento de baterías si no va a utilizar el OxImetro por
un largo periodo de tiempo.
12.4 Es mejor conservar el producto en un lugar seguro en donde la temperatura
ambiental varíe entre –40~60°C(-40~140°F) y la humedad entre ≤95%.
Se recomienda que conserve el producto en un medio ambiente seco.Un medio ambiente
húmedo puede afectar su vida útil y puede llegar a dañar el producto.
Limpiando el 18710
Limpie dentro del Oxímetro con un trapo suave y humedecido con alcohol etílico al 70%.
Limpie el dedo en donde va a realizar la prueba con alcohol antes de cada prueba.
No vacíe o rocíe cualquier tipo de líquidos dentro del Oxímetro. No permita que ningún
tipo de líquido penetre por las aberturas del dispositivo. Permita que el Oxímetro se
seque completamente antes de volver a utilizarlo.
13.Calibrando el 18710
• El probador funcional no puede utilizarse para evaluar la exactitud del Oxímetro.
• Los métodos de prueba usados para establecer la exactitud de SpO2 son pruebas
clínicas. El oxímetro es utilizado para medir los niveles de saturación arterial de
hemoglobina oxígeno y estos niveles son comparados a los niveles determinados de
muestras de sangre arterial con un CO-Oxímetro.
43
14. Possible Problems and resolutions
Problems
Possible Reason
Solution
El SpO2% o la
frecuencia de
pulso no aparece
normalmente
1. El dedo no está introducido
correctamente
2. El valor SpO2 del usuario es muy
bajo para poder ser leído
1. Vuelva a introducir el dedo
2. Existe iluminación excesiva
3. Mida más veces para asegurarse
que el producto no tenga problemas.
Por favor, visite un hospital para un
diagnóstico exacto
SpO2% o frecuencia
de pulso es inestable
1. El dedo puede no estar lo
sufi cientemente introducido
2. Movimiento excesivo del usuario
1. Vuelva a introducir el dedo de nuevo
2. Relájese.
El monitor no
enciende
1. No tiene batería o tiene baterías bajas
2. La batería puede haber sido instalada
incorrectamente.
3. El monitor puede estar dañado
1. Por favor, coloque una batería nueva
2. Vuelva a instalar la batería
3. Por favor, póngase en contacto con el
centro de servicio al cliente.
La indicación se
apaga de repente
1. El Oxímetro se apaga automáticamente
cuando no se detecta una señal por
más de 5 segundos.
2. Las baterías tienen muy poca
potencia para trabajar.
1. Normal
2. Reemplace la batería.
44
15. Declaración
Declaración del fabricante y orientación – emisiones electromagnéticas Para todos los EQUIPOS y SISTEMAS
Declaración del fabricante y orientación – emisión electromagnética Declaración del fabricante y orientación – ambiente electromagnético especifi cado a continuación. El cliente del
usuario del Oxímetro de Pulso (18710) deberá asegurarse que sea usado de tal manera y bajo dicho ambiente.
Prueba de emisión
Cumplimiento
Ambiente electromagnético – orientación
RF emisiones CISPR 11
Grupo 1
El Oxímetro de pulso (18710) utiliza energía RF
muy baja y es muy poco probable que ocasione
interferencia con equipo electrónico cercano.
RF emisiones CISPR 11
Clase B
Emisiones armónicas
IEC 61000-3-2
No
corresponde
Fluctuaciones de voltaje/
emisiones oscilantes
IEC 61000-3-2
No
corresponde
El Oxímetro de pulso (18710) se puede utilizar en
todos los lugares, incluyendo lugares domésticos
y lugares conectados directamente a la red de
suministro público de energía de bajo voltaje
que proporciona energía a edifi cios para uso
doméstico.
45
Declaración del fabricante y orientación – inmunidad electromagnética Para todos los EQUIPOS y SISTEMAS
Declaración del fabricante y orientación – inmunidad electromagnética
Declaración del fabricante y orientación – ambiente electromagnético especifi cado a continuación. El cliente del
usuario del Oxímetro de Pulso (18710) deberá asegurarse que sea usado de tal manera y bajo dicho ambiente.
Prueba de inmunidad Nivel de prueba
IEC 60601
Nivel de
cumplimiento
Ambiente electromagnético – orientación
Descarga
electrostática (ESD)
IEC 61000-4-2
+/- 6kV contacto
+/- 8kV aire
Los pisos deben ser de madera, concreto o
cerámica. Si los pisos están cubiertos con
material sintético, la humedad relativa
debe ser al menos del 30%.
3A/m
La frecuencia de los campos magnéticos
de energía debe estar a niveles
característicos típicos de lugares
comerciales u hospitales.
Frecuencia de energía
(50/60 Hz) del campo
magnético.
IEC 61000-4-8
+/- 6kV contacto
+/- 8kV aire
3A/m
46
Declaración del fabricante y orientación – inmunidad electromagnética Para todo EQUIPO y SISTEMAS que no sean de SOPORTE VITAL
Declaración del fabricante y orientación – inmunidad electromagnética
Declaración del fabricante y orientación – ambiente electromagnético especifi cado a continuación. El cliente del
and Manufacture’s declaration – electromagnetic immunityusuario del Oxímetro deGuidance
Pulso
deberá
asegurarse
que
de tal manera y bajo dicho ambiente.
For
all (18710)
EQUIPMENT
and SYSTEMS
that
aresea
not usado
LIFE-SUPPORTING
Guidance and Manufacture’s declaration – electromagnetic immunity-
Guidance and Manufacture’s declaration - electromagnetic immunity
Prueba de Guidance
Nivel de
Nivel de
For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
and Manufacture’s declaration
– electromagnetic
environment– speci
ed below. The customer or
Ambiente
electromagnético
orientación
user of the Pulse
Oximeter (18710) should assureGuidance
that it is used
such an environment.
and in
Manufacture’s
declaration - electromagnetic immunity
inmunidad theprueba
cumplimiento
Guidance
and
Manufacture’s
declaration – electromagnetic environment specied below. The c
IEC 60601 Compliance
Immunity
IEC
60601
El
equipo
de
comunicaciones
RF
portátil
noitdebe
utilizarse
cerca
Electromagnetic
Environment
–móvil
guidance
the user of the Pulse Oximeter (18710) should yassure
that
is used
in such an
environment.
Level
test level
test
deImmunity
cualquier
parte
del
de pulso
(18710),
incluyendo
cables, la disRF radiado
3 V/m
Portable
and
mobile
RFOxímetro
communications
equipment
should
be
Compliance
IEC
60601
3 V/m
Electromagnetic
Environment
used
no
closer
to
any
part
of
the
Pulse
Oximeter
(18710),
including
Level
Radiated
test
level
test recomendada de separación calculada del equipo correspondiente – guidan
tancia
IEC
3
V/m
80
MHz
to
than the recommended separation distance calculated
RF
3 V/m
Portableofand
RF communications equipment sh
a lacables,
frecuencia
del trasmisor.
2.5 GHz
from
the equation
the mobile
transmitter.
3 V/m applicable to the frequency
61000-4-3 IEC
80 MHz a
Radiated
Recommended
separation
distance used no closer to any part of the Pulse Oximeter (1871
61000-4-3
MHz
to
Distancia
de80
separación
recomendada.
cables, than the recommended separation distance ca
RF
3 V/m
2.5
GHz
2.5 GHz
from
the
equation
applicable
to the frequency of the tra
d=
MHz
to 800
MHz
IEC
P 8080
MHz
a 800
MHz Recommended separation distance
61000-4-3
800
MHz
a 2.5
GHz d=
d=
MHz
to 2.5
GHz
P 800
P 80 MHz to 800 MHz
thelamaximum
power
ofdel
thetrasmisor
transmitteren
in watts (W) de
EnWhere
dondeP Pises
energía output
máxima
de rating
salida
d=
800 d
MHz
to 2.5
GHz
P and
watts (W) according to the transmitter manufacturer
is the
acuerdo
a las especifi
caciones
delin fabricante
recommended
separation
distance
metres (m). y d es la distancia de separaWhere
P is the maximum
power rating of the tra
Field
strengths
from

xed
RF
transmitters,
as
determined
by
an
ción recomendada en metros
(m). Las
fuerzas
de campo
deoutput
trasmisores
RF
watts
(W)
according
to
the
transmitter
manufacturer
an
a
electromagnetic site survey , should be less than the compliance
recommended
separation distance
in metres
fi jos,
como
lo frequency
determina
unabevaluación
electromagnética
del lugar
a, no (m).
level
in each
range.
Field
strengths
from

xed
RF
transmitters,
as determin
Interference
may occur
in thede
vicinity
of equipmentdentro
markedde
with
deben
ser
menores
al
nivel
cumplimiento
cada
de
a,rango
electromagnetic
site
survey
should
be
less
than
the
following symbol:
level in each frequency range. b
frecuencia b.
Interference may occur in the vicinity of equipment mar
NOTE 1: At 80 MHz and 800 MHz, theInterferencia
higher frequency
range applies.
se puede
presentar alrededor
equipo que
following de
symbol:
NOTE 2: These guidelines may not apply in all situations, Electromagnetic propagation is affected by
tenga
elobjects
siguiente
símbolo:
absorption and reection structures,
and people.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
3.5
E1
7
E1
3.5
E1
7
E1
NOTE 2: These guidelines may not apply in all situations, Electromagnetic propagation is affect
- 12 NOTA 1: A 80 MHz y 800 MHz, se aplica el rango de
frecuencia
alto.
absorption
and remás
ection
structures, objects and people.
NOTA 2: Puede que estas pautas no se apliquen a todas las situaciones. La propagación
- 12 - electromagnética
se ve afectada por la absorción y refl exión de las estructuras, objetos y personas.
47
a Los campos de fuerza de trasmisores fi jos, como la estación base de radio, teléfonos (celulares/
inalámbricos) y radios móviles, radioafi cionados, transmisiones de radio AM y FM y transmisiones de
TV no se pueden predecir teoréticamente con exactitud. Para evaluar el ambiente electromagnético
debido a trasmisores RF fi jos debe de considerarse realizar una evaluación del lugar. Se debe de
observar el campo de fuerza del lugar en donde se va a utilizar el Oxímetro de pulso (18710) para
verifi car que opere normalmente. Si se observa una operación anormal se deben de tomar medidas
adicionales como reorientar o reubicar el Oximetro de pulso (18710).
b Sobre un rango de frecuencia 150 kHz a 80 MHz, los campos de fuerza deben ser menores a 3 V/m
a Field astrengths
Field strengths
from xed
from
transmitters,
xed transmitters,
such assuch
baseas
station
base for
station
radiofor
(cellular/cordless)
radio (cellular/cordless)
telephones
telephones
and
and
land mobile
land radios,
mobile amateur
radios, amateur
radio, AM
radio,
andAM
FMand
radio
FM
broadcast
radio broadcast
and TV and
broadcast
TV broadcast
cannot be
cannot
predicted
predicted
t
Distancias de
separación
recomendadas
entre
equipo
de
comunicación
RF
ybemóvil
yanelt
heoretically
heoretically
with accuracy.
with accuracy.
To assess
To assess
the
electromagnetic
the
electromagnetic
environment
environment
due to due
xed
to
RFportátil
xed
transmitters,
RF transmitters,
an
electromagnetic
site survey
site should
survey be
should
considered.
be considered.
If the measured
If the measured
eld strength
eld strength
in the location
in the location
in whichin which
EQUIPO o electromagnetic
SISTEMAS
Para
todo
EQUIPO
SISTEMAS
que
sean
de performance
SOPORTE
the
Pulse
theOximeter
Pulse -Oximeter
(18710)(18710)
should be
should
observed
be observed
toyverify
tonormal
verify operation.
normal
operation.
If no
abnormal
If abnormal
performance
is
is VITAL
observed,
observed,
additional
additional
measurements
measurements
may be may
necessary,
be necessary,
such assuch
reorienting
as reorienting
of the relocating
of the relocating
the Pulse
the Pulse
Oximeter
(18710).
(18710).
Distancias deOximeter
separación
recomendada
entre
b Over btheOver
frequency
theRF
frequency
range
150
range
150
to 80
kHz
80elds
MHz,strengths
elds
should(18710)
be
should
less be
than
less
3 V/m
than 3 V/m
equipo de comunicación
portátil
ykHz
móvil
yMHz,
eltoOxímetro
destrengths
pulso
Recommended
Recommended
separation
separation
distances
distances
between
between
portable
portable
and mobile
and mobile
RF communications
RF communications
equipment
equipment
El Oxímetro
diseñado
para
ser
usado
un
electromagnético
en donde
andde
thepulso
and
EQUIPMENT
the(18710)
EQUIPMENT
orestá
SYSTEMS
or
SYSTEMS
-For all
-For
EQUIPMENT
all EQUIPMENT
anden
SYSTEMS
andambiente
SYSTEMS
that arethat
notare
LIFE-SUPPORTING
not LIFE-SUPPORTING
Recommended
Recommended
separation
separation
distances
distances
between
between
las alteraciones por RFportable
radiado
estén
controladas.
El cliente
oequipment
usuario
del
Oxímetro
de pulso (18710)
portable
and mobile
and RF
mobile
communications
RF communications
equipment
and Pulse
andOximeter
Pulse Oximeter
(18710)(18710)
puede ayudar
a prevenir
la (18710)
interferencia
electromagnética
al mantener
la distancia
mínima
entre
equipo de
The Pulse
TheOximeter
Pulse Oximeter
(18710)
is intended
is intended
for use in
forelectromagnetic
use in electromagnetic
environment
environment
in whichinradiated
which radiated
RF
RF
disturbances
disturbances
are controlled.
are
controlled.
The(transmisores)
customer
The customer
or the user
or
ofOxímetro
the
userPulse
of theOximeter
Pulse
Oximeter
(18710)
(18710)
can help
can
prevent
help
prevent
comunicaciones
RF portátil
o móvil
y elthe
de
pulso
(18710)
como
se recomienda
a
electromagnetic
electromagnetic
interference
interference
by maintaining
by maintaining
a minimum
a minimum
distancedistance
betweenbetween
portableportable
and mobile
and RF
mobile RF
continuación,
de
acuerdo
a
la
máxima
energía
de
salida
del
equipo
de
comunicación.
communications
communications
equipment
equipment
(transmitters)
(transmitters)
and theand
Pulse
theOximeter
Pulse Oximeter
(18710)(18710)
as recommended
as recommended
below, below,
according
according
to the maximum
to the maximum
output power
outputofpower
the communications
of the communications
equipment.
equipment.
Distancia
de separación
de
acuerdo
la frecuencia
del
Máxima energía
de maximum
Separation
Separation
distance
distance
according
according
to frequency
to frequency
ofatransmitter
of transmitter
(m)
(m) trasmisor (m)
Rated maximum
Rated
output output
power ofpower
transmitter
of transmitter
(W)
(W)
salida del trasmisor
(W)
80
toto
MHz
800800
MHz
to 800
MHz d= 7 d=P 7 800PMHz
800
to MHz
2.5
GHz
toto
2.52.5
GHz
d= 3.5 d=P 3.5 80
80PMHz
MHz
MHz
800
MHz
GHz
E1
0.01
0.1
1
10
100
0.01
0.01
0.1
1
0.1
1
10
100
10
100
E1
E1
0.11670.1167 0.1167
0.36890.3689 0.3689
1.1667 1.1667
1.16673.6893 3.6893
3.689311.666711.6667
11.6667
E1
0.2334 0.2334
- 13 -- 13 -
0.2334
0.7378 0.7378
0.7378
2.3334 2.3334
2.3334
7.3786 7.3786
7.3786
23.3334
23.3334
23.3334
48
Para
trasmisoresrated
clasifiat
cados
con la máxima
salida
y no
especifi
anteriormente
se
For
transmitters
a maximum
outputenergía
powerde
not
listed
above,
thecados
recommended
sepratation
distance
recomienda
unacan
distancia
de separación
enequation
metros (m)applicable
que puedetocalcularse
usandooflathe
ecuación
d in
metres (m)
be estimated
using dthe
the frequency
transmitter, where P
For
transmitters
apower
maximum
output
not listed
above,
the
recommended
sepratation
distance
is
the
maximumrated
output
rating
of thepower
transmitter
(W)
according
to the
transmitter
manufacture
correspondiente
a la at
frecuencia
del trasmisor,
en donde
Pineswatts
la clasifi
cación
de energía
de
salida máxima
d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P
watts
(W)800
derating
acuerdo
al separation
fabricante
del
NOTE
1 At 80en
MHz
and
MHz,ofthe
distance
for according
the highertofrequency
rangemanufacturer.
applies.
is del
the trasmisor
maximum
output
power
the
transmitter
intrasmisor.
watts (W)
the transmitter
NOTE
guidelines
may
not apply
in all situations.
Electromagnetic
propagation
is affected
NOTA21: These
A 80 MHz
y 800 MHz,
se aplica
la distancia
de separación
para el rango de
frecuencia más
alto. by
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
absorption
and
re
ection
from
structures,
objects
and
people.
NOTA22:These
Puedeguidelines
que estas pautas
noapply
correspondan
a todasElectromagnetic
las situaciones. Lapropagation
propagación
NOTE
may not
in all situations.
is affected by
electromagnética
ve re
afectada
la structures,
absorción yobjects
refl exión
estructuras, objetos y personas.
absorptionse
and
ectionpor
from
anddepeople.
ansmitters rated at a maximum output power not listed above, the recommended sepratation distance
metres (m)
be estimated
using
the equation applicable to the frequency of the transmitter, where P
16.can
Symbol
Defi
nitions
16.
Declaración
maximum
output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
16. Symbol Definitions
E 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Symbol
Symbol
E 2 These
guidelines
apply De
in allnition
situations. Electromagnetic
propagation
isDefinición
affected by Denition
Símbolo
may not
Definición
Símbolo
nition objects and people.Symbol
Denition
Symbol
absorption
and reection from De
structures,
Low power
indication
Indicador
de baja
energía.
equipment
ElThe
equipo
es tipotype
BF is BF
The equipment type is BF
Symbol Definitions
No se utilice para monitoreo
Refer
to user manual
Vea
eltomanual
del usuario
DeRefer
nition
Symbol
user manual
before
application
antes
de
la aplicación.
before
application
mbol
pO2%
Low power indication
The equipment type is BF
Hemoglobin
Saturación
desaturation
hemoglobina
Hemoglobin
saturation
SpO2%
2%
SpO
Denition
No for continuous monitoring
continuo.
No
for continuous monitoring
Low power indication
No. de
serieNo.
Serial
SN SN
Serial
No.
Refer to user manual
pulserate
rate
(bpm)
pulse
(bpm)
PRbpm
bpm application
PR
before
Frecuencia cardíaca (bpm)
Hemoglobin saturation
No for continuous
Date
of Manufacture
Date
ofmonitoring
Manufacture
Fecha
de
Fabricación
SN
- 14
- - 14
Serial No.
49
Garantía Limitada De 2 Años
Su producto marca Drive está garantizado para estar libre de defectos en materiales y
fabricación por dos años para el comprador original.
Este aparato se construyó de acuerdo a estándares de exactitud y fue inspeccionado
cuidadosamente antes de su envío. La garantía limitada de 2 años es una muestra de
nuestra confi anza en los materiales y fabricación de nuestros productos y en nuestra
aseveración al consumidor de años fi ables de servicio.
En el caso de que se presente un defecto cubierto por esta garantía, nosotros, a nuestra
propia discreción, reemplazaremos la unidad.
Esta garantía no cubre las fallas de la unidad debido al mal uso o negligencia por parte
del dueño o por el uso y desgaste normal.
Si tiene preguntas sobre su dispositivo Drive o esta garantía, póngase en contacto con
un distribuidor autorizado Drive.
DRIVE MEDICAL DESIGN & MANUFACTURING
Phone: 877.224.0946 Fax: 516.998.4601 www.drivemedical.com