Gima OXY-10 User manual

PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
OXY-10 PULSOXIMETRO
OXY-10 PULSE OXIMETER
OXY-10 OXYMÈTRE DE POULS
OXY-10 OXÍMETRO DE DEDO
OXY-10 OXÍMETRO DE DEDO
OXY-10 FINGERPULSOXIMETER
OXY-10 PULSOKSYMETR NAPALCOWY
OXY-10 ΟΞΎΜΕΤΡΟ ΔΑΚΤΎΛΟΎ
OXY-10
Gima S.p.A
Via Marconi, 1 - 20060 Gessate (MI) Italy
Made in China
M35095-M-Rev.2-01.19
0476
ATTENZIONE: Gli operatori devono leggere e capire
completamente questo manuale prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read and completely
understand the present manual before using the product.
AVIS: Les opérateurs doivent lire et bien
comprendre ce manuel avant d’utiliser le produit.
ATENCIÓN: Los operadores tienen que leer
y entender completamente este manual antes
de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender
completamente este manual antes de usar o produto
ACHTUNG: Die Bediener müssen vorher dieses
Handbuch gelesen und verstanden haben,
bevor sie das Produkt benutzen.
UWAGA: przed rozpoczęciem użytkowania wyrobu operatorzy
muszą przeczytać podręcznik i upewnić się, iż wszystko to,
co jest w nim napisane jest dla nich jasne i zrozumiałe.
ΠΡΟΣΟΧΗ: Οι χειριστές αυτού του προϊόντος πρέπει να διαβάσουν και να
καταλάβουν πλήρως τις οδηγίες του εγχειριδίου πριν από την χρήση του.
Manuale d’uso - User manual - Manuel de l’utilisateur - Guía de Uso
Guia para utilização - Gebrauchsanweisung - Instrukcja obsługi
Οδηγίες χρήσης -
35095

19 ENGLISH
Instructions to User
Dear Users,
Thank you very much for purchasing our product. Please read the manual
very carefully before using this device. Failure to follow these instructions
can cause measuring abnormality or damage to the oximeter.
No part of this manual may be photocopied, reproduced or translated
into another language without the prior written consent.
We reserve the right to improve and amend it at any time without prior notice.
This device complies with Part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) this device may not cause harmful inter-
ference, and (2) this device must accept any interference received, including
interference that may cause undesired operation.
Warnings
Check the device to make sure that there is no visible damage that may
affect user’s safety or measurement performance with regard to sensors
and clips. It is recommended that the device should be inspected minimally
once a week. When there is obvious damage, stop using the device.
Special attention should be paid while the oximeter is used continuously
under the ambient temperature exceeds 37°C, burning hurt may occur
because of over-heating on the sensor.
An uncomfortable or painful feeling may appear if using the oximeter
continuously on the same place for a long time, especially for poor
microcirculation patients.
It is recommended that the oximeter should not be applied to the same
location for longer than 2 hours. If any abnormal condition is found, please
change the position of oximeter.
Avoid placing the device on the same limb which is wrapped with a cuff
for blood pressure measurement or during venous infusion.
DO NOT clip this device on edema or tender tissue.
The light (the infrared light is invisible) emitted from the device is harmful
to the eyes, so service technician or testee should not stare at the light.
The oximeter is not a treatment device.
When disposing of the monitor and its accessories, the local law should
be followed.

20
ENGLISH
Instructions for Operation
• The nger should be put in properly and correctly.
• Do not shake the nger. Keep at ease during measurement.
• Do not put wet nger directly into sensor.
• Avoid placing the device on the same limb which is wrapped with a cuff
for blood pressure measurement or during venous infusion.
• Do not let anything block the emitting light from device.
• Vigorous exercise and electrosurgical device interference may affect
the measuring accuracy.
• The orientation-sensor works on the basis of the gravity. A small movable
metal ball is built in the orientation-sensor for detecting the orientation
of the oximeter. When you want to change the oximeter’s display direction,
if you move the oximeter too slowly, the movable metal ball will also move
slowly because of not enough acceleration. Consequently the response
of orientation detection would be delayed. Please move the oximeter with
a bit of force if you want to change the display direction (such as bend/ex-
tend your nger quickly), so an acceleration is provided to the
orientation-sensor for quick sensing the orientation change.
• Using enamel or other makeup on the nail may affect the accuracy
of measurement, too long ngernail may casue failure of measurement
or unaccuracy measurement result.
• Keep the oximeter away from dust, vibration, corrosive substances,
explosive materials, high temperature and moisture.
• Existence of high intensive light sources, such as uorescence light,
ruby lamb, infrared heater or strong sunshire, etc. may cause unaccuracy
of measurement result. Please put an opaque cover on the sensor
or change the measuring site.
• If the rst reading appears with poor waveform (irregular or not smooth),
then the reading is unlikely true, the more stable value is expected
by waiting for a while, or a restart is needed when necessary.
Note: Due to the working principle of orientation sensor used in oximeter,
there is a small metal ball which is movable within its compartment
of the orientation-sensor. Therefore you can hear a slight “clatter” sound
when you wave or shake the oximeter. It is normal and not caused
by unwanted part.

21 ENGLISH
Content
1 Overview.................................................................................................................................... 22
1.1 Appearance...................................................................................................................... 22
1.2 Name and Model ........................................................................................................... 22
1.3 Intended Use ................................................................................................................... 22
1.4 Structure and Conformation .................................................................................... 22
1.5 Features.............................................................................................................................. 22
2 Battery Installation............................................................................................................... 23
3 Operation.................................................................................................................................. 23
3.1 Directly measurement.................................................................................................. 23
3.2 Alarm and alarm silence............................................................................................. 25
3.3 Menu Screen.................................................................................................................... 25
3.4 External SpO2Probe Connection.......................................................................... 26
3.5 Data transmission.......................................................................................................... 27
4 Technical Specications................................................................................................... 27
5 Accessories............................................................................................................................. 28
6 Repair and Maintenance.................................................................................................. 28
6.1 Oximeter Maintenance................................................................................................ 28
6.2 Battery Maintenance.................................................................................................... 29
6.3 Cleaning and Disinfecting Instruction ................................................................. 29
7 Troubleshooting..................................................................................................................... 30
Appendix ........................................................................................................................................... 31
A Key of Symbols ...................................................................................................................... 31
B SpO2Common Knowledge.............................................................................................. 31

22
1. Overview
1.1 Appearance
Figure 1 Front/Rear View
1.2 Name and Model
Name: Fingertip Oximeter
Model: OXY-10
1.3 Intended Use
This Fingertip Oximeter is intended for measuring the pulse rate and functional
oxygen saturation (SpO2) through patient’s nger. It is applicable for
spot-checking SpO2and pulse rate of adult and pediatric patients in homes
and clinics.
1.4 Structure and Conformation
It consists of main unit and photoelectric sensor, and additional data upload
connector.
1.5 Features
• Wireless data transmission can communicate with PC/mobile phone/PDA.
• External pediatric SpO2probe available
• Large true color OLED display of SpO2, PR Pulse Bar, PI & Plethysmogram
• Automatic change display direction
• Automatic power on/off
• Audible & visible alarm function
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23
• Pulse beep with pitch tone, pulse beep on/off and alarm limits can be set
via setup menu.
• Shift parameter display between PR and PI
• 2AAA alkaline batteries with low power consumption
• Low battery voltage indication
2. Battery Installation
Figure 2 Battery Installation
1. Refer to Figure2, insert two AAA size batteries into the battery compartment
properly.
2. Replace the cover.
Please make sure that the batteries are correctly installed, or incorrect
installation may cause the device not to work.
3. Operation
3.1 Directly measurement
1. Open the clip as shown in Figure 3.
Figure 3 Put nger into the Oximeter
2. Put nger into the rubber cushions of the clip (make sure the nger
is in the correct position), and then clip the nger.
3. The device will power on automatically in 2 seconds, and start to display
software version number.
4. Next enter into data display screen (as shown in Figure 4). User can read
the values and view the waveform from display screen.
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24
Figure4A Figure4B
Screen Description:
• “%SpO2”: SpO2symbol; “99”: SpO2value;
• “PR”: Pulse rate icon; “65”: Pulse rate value;
• “♥”: Pulse beat symbol;
• “ � ”: Pulse intensity histogram.
• “PI%”: Perfusion index icon; “1.4”: Perfusion index value;
• “ ”: Wireless symbol
☞Change display direction:
Tilt the oximeter to change display direction. It is better for user to read
value conveniently.
☞Shift parameter display between PR and PI during measurement:
Short time press Display Key to shift the 4A and 4B. When shown as 4B.
the display will shift 4A automatically after 20 seconds without operation.
☞Wireless icon “ ”:
The color of “ ” Denition
“ ”displays gray “Wireless” function is disabled
The device fails to setup a wireless
connection with the surrounding host.
“ ” ashes blue The device is being to establish a wireless
connection with the surrounding host.
“ ” long lights blue Successful wireless connection between
the device and a host is established.
No display “ ” icon Hardware failure of wireless transmission
function.
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25
When the device fails to try establishing wireless connection within 3 minutes,
the icon “ ” will become gray and the “Wireless” function is disabled
automatically. You have to enable it next time manually.
Notes: The pulse beep has the pitch-tone feature (when SpO2value
is higher than 90%), that means, the beeping tone changes according
to the SpO2value.
3.2 Alarm and alarm silence
When measuring, if SpO2value or pulse rate value exceeds the preset alarm
limit, the device will alarm automatically and the value which exceeds limit
on the screen will ash. The detailed information refers to chapter 4.
Apply for belowed methods to relief alarm sound when alarm event happens:
1. When SpO2value and PR value get normally.
2. Press Display Key to mute. If this alarm event continues, the oximeter will
resume alarm sound automatically 2 minutes later.
3. Remove the nger from the oximeter or SpO2probe.
3.3 Menu Screen
Figure 5 Menu Screen
Longtime press display key could enter the menu screen.
Menu screen description:
“Wireless”: the wireless on-off button. Transmitting data to PC when it is on.
“on” and “off” can be optional. The factory default is “on”.
“SpO2alm Lo”: SpO2alarm: Lower limit.The user can modify the value
of 85~99, the step is “1”, the default is 90.
“PR alm Hi”: Pulse Rate alarm upper limit. The user can modify the value
of 100~240, the step is “5”, the default is 120.
“PR alm Lo”: Pulse Rate alarm lower limit. The user can modify the value
of 30~60, the step is “1”, the default is 50.
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26
“Pulse beep”: Pulse beep button. When SpO2value (90~99) changes,
the pitch tone changes accordingly.
“Save, exit menu”: long time pressing this item to store and exit from
the setup menu then enter the display screen.
“Restore default”: Restore default setting. Refer to Figure 5 for each default
value.
On setup menu screen:
1. Short time press Display Key to choose the setting item;
2. Longtime press Display Key to active the setting item, then short time
press it to modify the setting parameter;
3. Next, longtime press Display Key to conrm the modication and exit from
this setting item.
4. At last, move the setting item to “Save, exit menu”, and long time pressing
Display Key to store the modication and exit from the setup menu.
3.4 External SpO2Probe Connection
1. Connect the external SpO2probe to SpO2sensor connector
in the following way. Make sure the side with “Arrow” faces upwards.
Figure 6 Probe Connection
Note: when the external SpO2probe is connected well, the built-in nger
clip sensor will be disabled. The measurement is detected from the
external SpO2probe.
2. The nger should be put in SpO2probe properly and correctly.
3. The oximeter will power on automatically 2 seconds later, then display
software version number.
4. Other operation is similar to chapter 3.1 directly measurement.
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27
3.5 Data transmission
This oximeter has the function of wireless data transmission. The user could
effectively transmit the data to computer through the wireless communication
module. Refer to the (Oximeter Data Manager) for detailed information.
4. Technical Specications
A. Technique: dual-wavelength LED sensor,
LED sensor wavelength:
Red light: 663 nanometers,
Infrared light: 890 nanometers.
Maximal optical output power:
less than 1.5mW maximum average.
B. SpO2measurement
Measuring range: 70%~100%
Measuring accuracy:
not greater than 3% for SpO2range from 70% to 100%
Note: Accuracy dened as root-mean-square value of deviation
according to ISO 9919.
SpO2alarm low limit range:
85%~99% (default 90%)
C. Pulse Rate measurement
Measuring range: 30bpm~240bpm
Measuring accuracy: ±2bpm or ±2% (whichever is greater)
Pulse Rate alarm range:
high limit: 100~240bpm (default 120bpm)
low limit: 30~60bpm (default 50bpm)
D. Perfusion Index (PI) Display
Range: 0.2%~20%
E. Audible &visual alarm function
When measuring, if SpO2value or pulse rate value exceeds the preset
alarm limit, the device will alarm automatically and the value which exceeds
limit on the screen will ash. The oximeter will shut down automatically
in 8 seconds with no signal.
F. Display mode: Color OLED Display
G. Power supply requirement:
2 x LR03 (AAA) alkaline batteries
Supply voltage: 3.0VDC
Operating current: ≤40mA
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28
H. Environment requirement
Operating Temperature: 5~40°C
Operating Humidity: 30~80%
Atmospheric pressure: 70~106kPa
I. The performance under low perfusion condition
The accuracy of SpO2and PR measurement still meet the precision
described above when the modulation amplitude is as low as 0.6%.
J. Resistance to ambient light interference:
The accuracy of SpO2 and PR measurement still meets the specication
described above when the device is tested by SpO2 simulator (Fluke
Biomedical Index 2 series) while setting the emulating interference of sun
light and 50Hz/60Hz uorescent light.
K. Dimensions: 60 mm (L) × 33 mm (W) × 30 mm (H)
Net Weight: 35g (including battery)
L. Classication:
The type of protection against electric shock: Internally powered
equipment.
The degree of protection against electric shock: Type BF applied parts.
The degree of protection against harmful ingress of liquids: Ordinary
equipment without protection against ingress of water.
Electro-Magnetic Compatibility: Group I, Class B
5. Accessories
A. A lanyard
B. Two batteries
C. A pouch
D. An External SpO2Probe (optional)
E. A User Manual
F. Installation CD (optional)
Note: The accessories are subject to change. Detailed items and quantity
see the Packing List.
6. Repair and Maintenance
6.1 Oximeter Maintenance
The service life (not a warranty) of this device is 5 years. In order to ensure its
long service life, please pay attention to the use of maintenance.
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29
• Please change the batteries when the low-voltage indicator lightens.
• Please clean the surface of the oximeter before use. Use soft cloth
with alcohol to wipe the oximeter rst, and then let it dry in air or wipe it dry.
• Please take out the batteries if the oximeter will not be used for a long time.
• The recommended storage environment of the device:
ambient temperature: -20ºC~60ºC,
relative humidity 10%~95%,
atmospheric pressure: 50kPa~107.4kPa.
• The oximeter is calibrated in the factory before sale, there is no need
to calibrate it during its life cycle. However, if it is necessary to verify
its accuracy routinely, the user can do the verication by means of SpO2
simulator, or it can be done by the local third party test house.
• Necessary servicing must be performed by qualied service engineers
ONLY. Users are not permitted to maintain it by themselves.
High-pressure sterilization cannot be used on the device.
Do not immerse the device in liquid.
6.2 Battery Maintenance
• Keep the both sides of coin cell clean.
• Low temperature may decrease the performance of coin cell, and low
battery indicator may appear early. In such case, please put coin cell into
pocket for warm before use, thus bring it back to normal condition.
• Do not let any conductive metal (such as tweezers) contact both sides
of coin cell simultaneously to avoid short circuit.
• Charge the coin cell for 8~10 hours each time; ambient temperature should
be 5~40°C.
• If the coin cell is full after charging, but its performance decreases
apparently, it means the coin cell is exhausted, please change a new one.
6.3 Cleaning and Disinfecting Instruction
• Surface-clean sensor with a soft cloth by wetting with a solution such
as 75% isopropyl alcohol, if low-level disinfection is required, use a 1:10
bleach solution.
• Then surface-clean by soft cloth wet with clean water and let air dry
or wipe it dry.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.
Do not use the sensor if it is damaged.
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7. Troubleshooting
Trouble Possible Reason Solution
Display direction
doesn’t change
or changes
insensitively.
The SpO2
and Pulse Rate
display unstable
Can not turn on
the device
No display
No display of the
wireless icon “ ”
Maybe the oximeter
is not used for a long
time, the movable metal
ball within the
orientation-sensor
can not move freely.
1. The nger is not placed
far enough inside.
2. The nger is shaking
or the patient
is moving.
1. The batteries are
drained or almost
drained.
2. The batteries are not
inserted properly.
3. The device
is malfunctioning.
1. The device will power
off automatically when
it gets no signal for
8 seconds.
2. The batteries
are almost drained.
Hardware failure of
wireless transmission
function.
Please shake the
oximeter with a certain
force to make the
movable metal ball
move freely.
If the problem still
exists, maybe
the orientation-sensor
is not working properly.
Please contact the
local service center.
1. Place the nger
correctly inside
and try again.
2. Let the patient
keep calm.
1. Change batteries.
2. Reinstall batteries.
3. Please contact the local
service center.
1. Normal.
2. Change batteries.
Please contact the local
service center.
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31
Appendix
A. Key of Symbols
B. SpO2Common Knowledge
1. Meaning of SpO2
SpO2is the saturation percentage of oxygen in the blood, so called O2
concentration in the blood; it is dened by the percentage of oxyhemoglobin
(HbO2) in the total hemoglobin of the arterial blood. SpO2is an important
physiological parameter to reect the respiration function; it is calculated
by the following method:
SpO2= HbO2/ (HbO2+Hb)×100%
HbO2are the oxyhemoglobins (oxygenized hemoglobin), Hb are those
hemoglobins which release oxygen.
2. Principle of Measurement
Based on Lamber-Beer law, the light absorbance of a given substance
is directly proportional with its density or concentration. When the light
with certain wavelength emits on human tissue, the measured intensity of light
after absorption, reecting and attenuation in tissue can reect the structure
character of the tissue by which the light passes. Due to that oxygenated
hemoglobin (HbO2) and deoxygenated hemoglobin (Hb) have different
Symbol Description Symbol Description
Type BF applied part WEEE disposal
Caution: read instructions
(warnings) carefully Keep away from sunlight
Follow instructions for use Keep in a cool,
dry place
%SpO2The pulse oxygen
saturation
Medical Device complies
with Directive 93/42/EEC
PR Pulse rate (beats per minute) Product code
Pulse rate icon Serial number
Low battery voltage Manufacturer
Wireless Date of manufacture
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3232
absorption character in the spectrum range from red to infrared light
(600nm~1000nm wavelength), by using these characteristics, SpO2can be
determined. SpO2measured by this oximeter is the functional oxygen
saturation - a percentage of the hemoglobin that can transport oxygen.
In contrast, hemoximeters report fractional oxygen saturation - a percentage
of all measured hemoglobin, including dysfunctional hemoglobin, such
as carboxyhemoglobin or metahemoglobin.
Clinical application of pulse oximeters: SpO2is an important physiological
parameter to reect the respiration and ventilation function, so SpO2
monitoring used in treatment has become more popular. (For example,
such as monitoring patients with serious respiratory disease, patients under
anesthesia during operation and premature and neonatal infants) The status
of SpO2can be determined in timely manner by measurement and will allow
nding the hypoxemia patient earlier, thereby preventing or reducing
accidental death caused by hypoxia effectively.
3. Factors affecting SpO2measuring accuracy (interference reason)
• Intravascular dyes such as indocyanine green or methylene blue
• Exposure to excessive illumination, such as surgical lamps, bilirubin lamps,
uorescent lights, infrared heating lamps, or direct sunlight.
• Vascular dyes or external used color-up product such as nail enamel
or color skin care
• Excessive patient movement
• Placement of a sensor on an extremity with a blood pressure cuff, arterial
catheter, or intravascular line
• Exposure to the chamber with High pressure oxygen
• There is an arterial occlusion proximal to the sensor
• Blood vessel contraction caused by peripheral vessel hyperkinesias
or body temperature decreasing
4. Factors causing low SpO2Measuring value (pathology reason)
• Hypoxemia disease, functional lack of HbO2
• Pigmentation or abnormal oxyhemoglobin level
• Abnormal oxyhemoglobin variation
• Methemoglobin disease
• Sulfhemoglobinemia or arterial occlusion exists near sensor
• Obvious venous pulsations
• Peripheral arterial pulsation becomes weak
• Peripheral blood supply is not enough
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33
Disposal: The product must not be disposed of along with other do-
mestic waste. The users must dispose of this equipment by bringing it
to a specic recycling point for electric and electronic equipment. For
further information on recycling points contact
the local authorities, the local recycling center or the shop where the
product was purchased. If the equipment is not disposed
of correctly, nes or penalties may be applied in accordance
with the national legislation and regulations.
GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product. This product meets high
qualitative standards both as regards the material and the production.
The warranty is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace free
of charge all the defected parts due to production reasons.
Labor costs and personnel traveling expenses and packaging not included.
All components subject to wear are not included in the warranty.
The repair or replacement performed during the warranty period shall not
extend the warranty. The warranty is void in the following cases: repairs
performed by unauthorized personnel or with non-original spare parts, defects
caused by negligence or incorrect use. GIMA cannot be held responsible for
malfunctioning on electronic devices or software due to outside agents such as:
voltage changes, electro-magnetic elds, radio interferences, etc. The warranty
is void if the above regulations are not observed and if the serial code (if availa-
ble) has been removed, cancelled or changed.
The defected products must be returned only to the dealer the product was
purchased from. Products sent to GIMA will be rejected.
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162
Guidance and manufacture’s declaration-electromagnetic emission
The Fingertip Oximeter is intended for use in the electromagnetic environments specied
below, the customer or the user of the Fingertip Oximeter 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
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete
or ceramic tile. If oors are
covered with synthetic material,
the relative humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
N/A N/A
Surge
IEC 61000-4-5
± 1 kV line(s)
to line(s)
± 2 kV line(s)
to earth
N/A N/A
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
<40% UT
(60% dip in UT)
for 5 cycle
<70% UUT
(30% dip in UT)
for 25 cycle
<5% UT
(>95% dip in UT)
for 5 sec
N/A N/A
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
3A/m 3A/m Power frequency magnetic elds
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
Note: UTis the a.c. mains voltage prior to application of the test level.

163
Guidance and manufacturer’s declaration – electromagnetic immunity
The Fingertip Oximeter is intended for use in the electromagnetic environment specied below.
The customer or the user of the Fingertip Oximeter should assure that it is used in such an
electromagnetic environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment -
guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3Vrms
150 KHz
to 80 MHz
3V/m
80 MHz
to 2.5 GHz
N/A
3V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Fingertip Oximeter, including
cables, than the recommended separation
distance calculated from the equation appli-
cable to the frequency of the transmitter.
Recommended separation distance
d= 1.2 √P
d = 1.2 √P80MHz to 800MHz
d= 2.3 √P800MHz to 2.5GHz
Where Pis the maximum output power rating
of the transmitter in watts (W) according
to the transmitter manufacturer and dis the
recommended separation distance in metres
(m).bField strengths from xed RF
transmitters, as determined by an
electromagnetic site survey,ashould be less
than the compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reection from structures, objects and people..
a Field strengths from xed transmitters, such as base stations 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 xed RF transmitters, an electromagnetic site survey should be
considered. If the measured eld strength in the location in which the Fingertip Oximeter
is used exceeds themapplicable RF compliance level above, the Fingertip Oximeter should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.