Contec CMS50DL1 User manual

CMS50DL1 User Manual
P u l s e O x i m e t e r
Contec Medical Systems Co., Ltd.
Address:No.112 Qinhuang West Street, Economic ＆Technical
Development Zone, Qinhuangdao, Hebei Province, PEOPLE’S
REPUBLIC OF CHINA
Tel: [phone]
Fax: [phone]
Technical support:[phone]
E-mail: [email protected]om.cn
Website: http://www.contecmed.com
EC REPRESENTATIVE
Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestrasse 80, 20537, Hamburg, Germany
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
CMS2.782.179(CE.USA)ESS/1.9 1.4.01.01.701 2021.02
Instructions to User
Dear users, thank you very much for purchasing the Pulse Oximeter (hereinafter
referred to as device).
This Manual is written and compiled in accordance with the council directive
MDD93/42/EEC for medical devices and harmonized standards. In case of
modifications and software upgrades, the information contained in this document is
subject to change without notice.
It is a medical device, which can be used repeatedly.
The Manual describes, in accordance with the device’s features and requirements,
main structure, functions, specifications, correct methods for transportation,
installation, usage, operation, repair, maintenance and storage, etc. as well as the
safety procedures to protect both the user and device. Refer to the respective chapters
for details.
Please read the User Manual carefully before using this device. The User Manual
which describes the operating procedures should be followed strictly. Failure to
follow the User Manual may cause measuring abnormality, device damage and
human injury. The manufacturer is NOT responsible for the safety, reliability and
performance issues and any monitoring abnormality, human injury and device
damage due to users' negligence of the operation instructions. The manufacturer’s
warranty service does not cover such faults.
Owing to the forthcoming renovation, the specific products you received may not be
totally in accordance with the description of this User Manual. We would sincerely
regret for that.
Our company has the final interpretation to this manual. The content of this manual is
subject to change without prior notice.
Warnings
Remind that it may cause serious consequences to tester, user or environment.
Explosive hazard—DO NOT use the device in environment with inflammable
gas such as anesthetic.
DO NOT use the device while examining by MRI or CT, as the induced current
may cause burn.
Do not take the information displayed on the device as the sole basis for clinical
diagnosis. The device is only used as an auxiliary means in diagnosis. And it
must be used in conjunction with doctor’s advice, clinical manifestations and
symptoms.
The maintenance to the device. Users are not permitted to maintain or refit the
device by themselves.
Uncomfortable or painful feeling may appear if using the device ceaselessly,
especially for the microcirculation disturbance users. It is not recommended that
the sensor is used on the same finger for more than 2 hours.
For some special users who need a more careful inspection on the test site,
please don’t place the device on the edema or tender tissue.
Please do not stare at the red and infrared light emitter (the infrared light is
invisible) after turning on the device, including the maintenance staff, as it may
be harmful to the eyes.
The device contains silicone, PVC, TPU, TPE and ABS materials, whose
biocompatibility has been tested in accordance with the requirements in ISO
10993-1, and it has passed the recommended biocompatibility test. The person
who is allergic to silicone, PVC, TPU, TPE or ABS can not use this device.
Do NOT strand the lanyard to avoid device drop and damage. The lanyard is
made of insensitive material. Please do not use it if any person is allergic to
lanyard. Do not wrap the lanyard around neck to avoid an accident.
The disposal of scrap device, its accessories and packaging should follow the
local laws and regulations, to avoid polluting to the local environment. And the
packaging materials must be placed in the region where the children are out of
reaching.
The device can not be used with the equipment not specified in the Manual. Only the
accessories appointed or recommended by the manufacturer can be used, otherwise it
may cause injury to the tester and operator or damage to the device.
Check the device before use to make sure that there is no visible damage that may affect
user’s safety and device performance. When there is obvious damage, please replace the
damaged parts before use.
Functional testers can not be used to assess the accuracy of the Pulse Oximeter.
Some functional testers or patient simulators can be used to verify whether the device
works normally, for example, INDEX-2LFE Simulator (software version: 3.00), please
refer to the Manual for the detailed operation steps.
Some functional testers or patient simulators can measure the accuracy of the device
copied calibration curve, but theycan not be used to evaluate the device accuracy.
When using the device, please keep it away from the equipment which can generate
strong electric field or strong magnetic field. Using the device in an inappropriate
environment may cause interference to the surrounding radio equipment or affect its
working.
The measured accuracy will be affected by the interference of electrosurgical equipment.
When several products are used on the same patient simultaneously, danger may occur
which is arisen from the overlap of leakage current.
CO poisoning will appear excessive estimation, so it is not recommended to use the
device.
This device is not intended for treatment.
The intended operator of the device maybe a patient.
Avoid maintaining the device during using.
1Overview
The oxygen saturation is the percentage of HbO2in the total Hb in the blood, so-called the O2
concentration in the blood, it is an important physiological parameter for the respiratory and
circulatory system. A number of diseases related to respiratory system may cause the
decrease of SpO2in the blood, furthermore, some other causes such as the malfunction of
human body's self-adjustment, damages during surgery, and the injuries caused by some
medical checkup would also lead to the difficulty of oxygen supply in human body, and the
corresponding symptoms would appear as a consequence, such as vertigo, impotence, vomit
etc. Serious symptoms might bring danger to human's life. Therefore, prompt information of
patients' SpO2is of great help for the doctor to discover the potential danger, and is of great
importance in the clinical medical field.
Insert the finger when measuring, the device will directly display the SpO2value measured, it
has a higher accuracy and repeatability.
1.1 Features
A. Easy to use.
B. Small in volume, light in weight, convenient to carry.
C. Low power consumption.
1.2 Applied range
The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate
through finger, and indicate the pulse intensity by the bar-display. The product is suitable for
use in family, hospital(Ordinary sickroom ), Oxygen Bar, social medical organizations and
also the measure of saturation oxygen and pulse rate.
1.3 Environment requirements
Storage Environment
a) Temperature: -40 ℃~ + 60 ℃
b) Relative humidity: ≤95%
c) Atmospheric pressure: 500 hPa ~ 1060 hPa
Operating Environment
a) Temperature: +10 ℃~ + 40 ℃
b) Relative Humidity: ≤75%
c) Atmospheric pressure: 700 hPa ~ 1060 hPa
1.4 Precautions
1.4.1Attention
Point out conditions or practices that may cause damage to the device or other properties.
Before using the device, make sure that it locates in normal working state and operating
environment.
In order to get a more accurate measurement, it should be used in a quiet and
comfortable environment.
When it is carried from cold environment to warm or humid environment, please do not
use it immediately.
If the device is splashed or coagulated by water, please stop operating.
DO NOT operate the device with sharp things.
High temperature, high pressure, gas sterilizing or immersion disinfection for the device
is not permitted. Refer to User Manual in the relative chapter (6.1) for cleaning and
disinfection..Please take out the internal battery before cleaning and disinfection.
The device is suitable for children and adult.
The device may not be suitable for all users, if you can't get a satisfactory result, please
stop using it.
Data averaging and signal processing have a delay in the upgrade of SpO2data values.
When the data update period is less than 30 seconds, the time for obtaining dynamic
average values will increase, which is arisen from signal degradation, low perfusion or
other interference, it depends on the PR value.
The device has 3-year service life, date of manufacture: see the label.
The device hasn't low-voltage prompt function, it only shows the low-voltage, please
change the battery when the battery voltage is used up.
The maximum temperature at the SpO2probe -tissue interface should be less than 41℃
which is measured bythe temperature tester.
During measuring, when abnormal conditions appear on the screen, please pull out your
finger and reinsert it to measure again.
If some unknown error appears during measuring, remove the battery to terminate
operating.
Do not contort or drag the wire of the device.
The plethysmographic waveform is not normalized, as a signal inadequacy indicator,
when it is not smooth and stable, the accuracy of the measured value may degrade.
When it tends to be smooth and stable, the measured value read is the optimal and the
waveform at this time is also the most standard.
.If the device or component is intended for single-use, then the repeated use of these
parts will pose risks on the parameters and technical parameters of the equipment
known to the manufacturer.
If necessary, our company can provide some information (such as circuit diagrams,
component lists, illustrations, etc.), so that the qualified technical personnel of the user
can repair the device components designated by our company.
The measured results will be influenced by the external colouring agent (such as nail
polish, colouring agent or color skin care products, etc.), so don't use them on the test
site.
As to the fingers which are too cold or too thin or whose fingernail is too long, it may
affect the measured results, so please insert the thicker finger such as thumb or middle
finger deeply enough into the probe when measuring.
The finger should be placed correctly (see Attached figure 5), as improper installation
or improper contact position for sensor will influence the measurement.
The light between the photoelectric receiving tube and the light-emitting tube of the
device must pass through the subject’s arteriole. Make sure the optical path is free from
any optical obstacles like rubberized fabric, to avoid inaccurate results.
Excessive ambient light may affect the measured results, such as surgical light
(especially xenon light sources), bilirubin lamp, fluorescent lamp, infrared heater and
direct sunlight, etc. In order to prevent interference from ambient light, make sure to
place the sensor properly and cover the sensor with opaque material.
Frequent movement (active or passive) of the subject or severe activity can affect the
measured accuracy.
The Pulse Oximeter should not be placed on a limb with the blood pressure cuff, arterial
ductus or intraluminal tube.
The measured value may be inaccurate during defibrillation and in a short period after
defibrillation, as it has not defibrillation function.
The device has been calibrated before leaving factory.
The device is calibrated to display functional oxygen saturation.
The equipment connected with the Oximeter interface should comply with the
requirements of IEC 60601-1.
1.4.2 Clinical restriction
A. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of
subject is required. For a subject with weak pulse due to shock, low ambient/body
temperature, major bleeding, or use of vascular contracting drug, the SpO2waveform
(PLETH) will decrease. In this case, the measurement will be more sensitive to interference.
B. The measurement will be influenced by intravascular staining agents (such as indocyanine
green or methylene blue), skin pigmentation.
C. The measured value may be normal seemingly for the tester who has anemia or
dysfunctional hemoglobin(such as carboxyhaemoglobin (COHb), methaemoglobin (MetHb)
and sulfhaemoglobin (SuHb)), but the tester may appear hypoxia, it is recommended to
perform further assessment according the clinical situations and symptoms.
D. Pulse oxygen only has a reference meaning for anemia and toxic hypoxia, as some severe
anemia patients still show better pulse oxygen measured valued.
E. Contraindication: no
2 Principle
Figure 1 Operating principle
Principle of the Oximeter is as follows: An experience formula of data process is established
taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of
Reductive Hemoglobin (Hb) and Oxyhemoglobin (HbO2) in glow & near-infrared zones.
Operation principle of the device is: Photoelectric Oxyhemoglobin Inspection Technology is
adopted in accordance with Capacity Pulse Scanning & Recording Technology, so that two
beams of different wavelength of lights can be focused onto human nail tip through
perspective clamp finger-type sensor. Then measured signal can be obtained by a
photosensitive element, information acquired through which will be shown on screen through
treatment in electronic circuits and microprocessor.
3 Functions
A. SpO2value display
B. PR value and bar graph display
C. Low-battery indication: low-battery indication appears when the battery voltage is
too low to work
D. Automatic standby function
4 Installation
4.1 View of the front panel
Figure 2 Front View
4.2 Battery
Step 1. Refer to Figure 3-1 and insert the two AAA size batteries properly in the right
direction.
Step 2. Replace the cover.
Please take care when you insert the batteries for the improper insertion
may damage the device.
Sketch map for the back cover in ON/OFF state refer to Figure 3-2:
Figure 3-1 Batteries Installation Figure 3-2 Installation for the Back Cover
4.3 Mounting the hanging rope
Step 1. Put the end of the rope through the hole.
Step 2. Put another end of the rope through the first one and then tighten it.
Figure 4. Mounting the hanging rope.
4.4 Structure, accessories and software description
A. Structure: main unit.
B. Accessories: one User Manual, one hanging rope.
Please check the device and accessories according to the list to avoid that the
device can not work normally.
C. Software description
Software name: CMS50DL embedded software
Software specification: no
Release version: V2.0
Naming rule for version: V <Major enhancive software upgrade>.<Minor enhancive
software upgrade>.<Improvement software upgrade>
Involved algorithm: name: plethysmography; type: mature arithmetic
Purpose: be used to measure SpO2, pulse rate, etc.
Clinical function: calculate SpO2and pulse rate values by collecting and processing
the testee’s pulse signal.
5 Operating Guide
5.1 Insert the two batteries properly to the direction, and then replace the
cover.
5.2 Open the clip as shown in Figure 5.
Figure 5. Put finger in position
5.3 Let the patient’s finger put into the rubber cushions of the clip (make sure
the finger is in the right position), and then clip the finger.
5.4 Press the button once on front panel.
5.5 Do not shake the finger and keep the patient at ease during the
process.Meanwhile, human body is not recommended in movement status.
5.6 Get the information directly from screen display.

5.7 In boot-strap state,press button ,and the device is reset.
Fingernails and the luminescent tube should be on the same side.
6 Maintain, Transport and Storage
6.1 Cleaning and disinfection
The device must be turned off before cleaning, and it should not be immersed into
liquid.
Please take out the internal battery before cleaning, do not immerse it into liquid.
Use 75% alcohol to wipe the device enclosure, and use liquid soap or isopropanol to
wipe the watchband for disinfection, nature dry or clean it with clean and soft cloth.
Do not spray any liquid on the device directly, and avoid liquid penetrating into the
device.
6.2 Maintenance
A. Check the main unit and all accessories periodically to make sure that there is no
visible damage that may affect patient’s safety and monitoring performance. It is
recommended that the device should be inspected weekly at least. When there is
obvious damage, stop using it.
B. Please clean and disinfect the device before/after using it according to the User
Manual (6.1).
C. Please replace the batteries in time when low-battery appears.
D.Please take out the batteries if the device is not used for a long time.
E. The device need not to be calibrated during maintenance.
6.3 Transport and Storage
A. The packed device can be transported by ordinary conveyance or according to
transport contract. During transportation, avoid strong shock, vibration and splashing
with rain or snow, and it can not be transported mixed with toxic, harmful, corrosive
material.
B. The packed device should be stored in room with no corrosive gases and good
ventilation. Temperature: -40°C~+60°C; Relative humidity: ≤95%.
7 Troubleshooting
Trouble
Possible Reason
Solution
The SpO2and
Pulse Rate
can not be
displayed
normally
1) The finger is not properly
inserted.
2) The finger is shaking or
the patient is moving.
3) The device is not used in
environment required by
the manual.
4) The device works
abnormally.
1) Please insert the finger
properly and measure
again.
2) Let the patient keep
calm.
3) Please use the device
in normal
environment.
4) Please contact the
after-sales.
The SpO2and
Pulse Rate
are not
displayed
stably
1) The finger is not placed
inside deep enough.
2) The finger is shaking or the
patient is moving.
1) Place the finger
properly and try again.
2) Let the patient keep
calm
The device
can not be
turned on
1) The battery is drained
away or almost drained
away.
2) The battery is installed
incorrectly.
3) The device’s malfunction.
1) Please change
batteries.
2) Please Install the
battery again.
3) Please contact the
local service center.
The display is
off suddenly
1) The device enters into the
energy saving mode.
2) Low battery.
3) The device works
abnormally.
1) Normal.
2) Please charge the
battery.
3) Please contact the
after-sales.
8 Key of Symbols
Symbol
Description
Type BF
Refer to instruction manual/booklet
%SpO2
The pulse oxygen saturation(%)
PRbpm
Pulse rate (bpm)
The battery voltage indication is deficient
(change the battery in time avoiding the inexact measure)
1. No finger inserted
2. An indicator of signal inadequacy
Battery positive electrode
Battery cathode
Exit standby mode
SN
Serial number
Alarm inhibit
WEEE (2002/96/EC)
IP22
Ingress of liquids rank
Storage and Transport Temperature limitation
Storage and Transport Humidity limitation
Storage and TransportAtmospheric pressure limitation
This side up
Fragile, handle with care
Keep dry
Recyclable
European Representative
This item is compliant with Directive 93/42/EEC of 14
june 1993 concerning medical devices; Including, at 21
march 2010, the amendments by Council Directive
2007/47/EEC.
Note：Your device may not contain all the following symbols.
9 Function Specification
SpO2[see note 1]
Display range
0% ~ 99%
Measured range
0% ~ 100%
Accuracy [see note 2]
70%~100%: ±2%;
0%~69%: unspecified.
Resolution
1%
PR
Display range
30 bpm ~ 250 bpm
Measured range
30 bpm ~ 250 bpm
Accuracy
±2 bpm or ±2%, whichever is greater.
Resolution
1 bpm
Accuracy under low
perfusion [see note 3]
Low perfusion 0.4%:
SpO2: ±4%;
PR: ±2 bpm or ±2%, whichever is greater
Light interference
Under normal and ambient light conditions, the SpO2
deviation ≤ 1%
Optical sensor [see note 4]
Red light
Wavelength: about 660 nm, optical output power: < 6.65 mW
Infrared light
Wavelength: about 905 nm, optical output power: < 6.75 mW
Safety class
Internally powered equipment, type BF applied part
International
Protection
IP22
Working voltage
DC 2.6 V ~ 3.6 V
Working current
≤25 mA
Power supply
1.5V (AAA size) alkaline batteries ×2 or rechargeable battery
Battery life
Two batteries can work continually for 24 hours
Dimension and Weight
Dimension
61 (L) ×36 (W) ×32 (H) mm
Weight
About 60g (with the batteries)
Note 1: the claims of SpO2accuracy shall be supported by clinical study measurements
taken over the full range. By artificial inducing, get the stable oxygen level to the range
of 70 % to 100 % SpO2, compare the SpO2values collected by the secondary standard
pulse oximeter equipment and the tested equipment at the same time, to form paired
data, which are used for the accuracy analysis.
There are 12 healthy volunteers (male: 6. female: 6; age: 18~45; skin color: black: 2, light: 8,
white: 2) data in the clinical report.
Note 2: because pulse oximeter equipment measurements are statistically distributed,
only about two-thirds of pulse oximeter equipment measurements can be expected to
fall within ±Arms of the value measured by a CO-OXIMETER.
Note 3: percentage modulation of infrared signal as the indication of pulsating signal
strength, patient simulator has been used to verify its accuracy under conditions of low
perfusion. SpO2and PR values are different due to low signal conditions, compare them
with the known SpO2and PR values of input signal.
Note 4: optical sensors as the light-emitting components, will affect other medical
devices applied the wavelength range. The information may be useful for the clinicians
who carry out the optical treatment.For example, photodynamic therapy operated by
clinician.
Note 5: Patient simulator has been used to verify the pulse rate accuracy, it is stated as
the root-mean-square difference between the PR measurement value and the value set
by simulator.
EMC
Note:
The device is subject to special EMC precautions and it must be installed and used in
accordance with these guidelines.
The electromagnetic field can affect the device performance, so other equipment used
near the device must meet the corresponding EMC requirements. Mobile phones,
X-rays or MRI devices are possible interference source, as they can emit high-intensity
electromagnetic radiation.
Refer to above chapters for the minimum value of user’s physiological signal.
Inaccurate result will appear when the device operates with the values lower than the
descriptions in above chapter
The use of ACCESSORIES, transducers and cables other than those specified, with the
exception of transducers and cables sold by the MANUFACTURER of the ME
EQUIPMENT or ME SYSTEM as replacement parts for internal components, may
result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or
ME SYSTEM.
The device should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, it should be observed to verify normal operation in
the configuration in which it will be used.
Devices or systems may still be interfered by other equipment, even if other equipment
meets the requirements of the corresponding national standard.
Basic performance: SpO2measured range: 70% ~ 100%, absolute error: ±2%; PR
measured range: 30 bpm ~ 250 bpm, accuracy: ±2 bpm or ±2%, whichever is greater.
Appendix 1
Guidance and manufacture's declaration
Guidance and manufacture’s declaration – electromagnetic emissions-
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
The Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The customer of the user of the Pulse Oximeter should assure that it is used in such and
environment.
Emission test
Compliance
Electromagnetic environment –guidance
RF emissions
CISPR 11
Group 1
The Pulse Oximeter uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference
in nearbyelectronic equipment.
RF emission
CISPR 11
Class B
The Pulse Oximeter 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.
Guidance and manufacture’s declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The customer or the user of Pulse Oximeter should assure that it is used in such an
environment.
Immunity
test
IEC
60601
test level
Complia
nce level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
8 kV
contact
15 kV air
8 kV
contact
15 kV air
Floors should be wood, concrete or
ceramic tile. If floor are covered
with synthetic material, the relative
humidityshould be at least 30%. the
manufacturer may recommend the
ESD precautionary procedures to
user.
Power frequency
(50Hz) magnetic
field
IEC 61000-4-8
30A/m
30A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
Guidance and manufacture’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The Pulse Oximeter isintended for usein the electromagnetic environmentspecified below.
The customer or the user of Pulse Oximeter should assure that it is used in such an
environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Conducted
RF IEC
61000-4-6
Radiated
RF IEC
61000-4-3
3V(0.15MH
z–80MHz),
6V(in ISM
bands
between
0.15MHz
and
80MHz)
10 V/m
80 MHz to
2.7GH
3V(0.15MHz
–80MHz),6V
(in ISM
bands
between
0.15MHz and
80MHz)
10 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Pulse Oximeter, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.7 GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the compliance
level in each frequencyrange.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, thehigher frequencyrange applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected byabsorption andreflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio(cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FMradio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. Ifthe measured field strength in the location in which thePulse Oximeter is
used exceeds the applicable RF compliance level above, the Pulse Oximeter should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Pulse Oximeter.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m.
Recommended separation distances between portable and mobile
RFcommunications equipment and the EQUIPMENTor SYSTEM –
for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RFcommunications equipment and the Pulse Oximeter.
The Pulse Oximeter is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Pulse Oximeter
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the Pulse
Oximeter as recommended below, according to the maximum output power of the
communications equipment.
Rated
maximum
output
power of
transmitter
(W)
Separation distance according to frequency of transmitter(m)
150 kHz to 80 MHz
P
V
d






1
5.3
80 MHz to 800 MHz
P
E
d






1
5.3
800 MHz to 2.7 GHz
P
E
d






1
7
0.01
0.058
0.035
0.07
0.1
0.18
0.11
0.22
1
0.58
0.35
0.7
10
1.83
1.10
2.21
100
5.8
3.5
7
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
P
V
d






1
5.3
P
E
d






1
5.3
P
E
d





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1
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§15.19 Labeling requirements.
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 interference, and (2)
this device must accept any interference received, including interference that may
cause undesired operation.
§15.21 Information to user.
Any Changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate the equipment.
§15.105 Information to the user.
Note: This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential installation.
This equipment generates uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.