Contec Medical Systems Co. CMS50S User manual

CMS50S 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:[e-mail]
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: shholdi[email protected]m
CMS2.782.492(CE)ESS/1.0 1.4.01.01.798 2021.04
User Notice
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 or replacement of the batterycan only be
performed by qualified service personnel specified by manufacturer, dangers
(such as over-temperature, fire or explosion) may occur when replacing the
battery by the personnel not fully trained. 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.
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.
The SpO2probe accompanied is only suitable for using with the device. The
device can only use the SpO2probe described in the Manual, so the operator has
the responsibility to check the compatibility between the device and the SpO2
probe before using, incompatible accessories may cause device performance
degradation, device damage or user injury.
Do not reprocess the accompanying SpO2probe.
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.
When the message ―Sensor Off‖ or ―Sensor Fault‖ appears, it indicates that the SpO2
probe is disconnected or line fault occurs. Check the connection of the SpO2probe and
whether there is damage for the probe, if necessary, please replace the probe to avoid
risks. The probe fault will not result in a safety hazard.
Functional testers can not be used to assess the accuracy of the SpO2probe and 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 they can 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.
When storing the device, keep it away from children, pets and insects to avoid affecting its
performance.
Do not place the device in places exposed to direct sunlight, high temperature, humidity, dust,
cotton wool or easy to splash water, to avoid affecting its performance.
The measured accuracy will be affected by the interference of electrosurgical equipment.
When several products are used on the same people 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 may be a user.
Avoid maintaining the device during using.
The device should be operated by medical personnel via professional training,or
non-medical personnel who have been guided.
1 Overview
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
users' 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 record the SpO2value measured, it
has 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 Indication for Use
The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate
through finger. The product is suitable for being used in family, oxygen bar, physical care in
sports (It can be used before or after doing sports, and it is not recommended to use the device
during the process of having sport) and etc.
1.3 Environment requirements
Storage Environment
a) Temperature: -40℃~+60℃
b) Relative humidity: ≤95%
c) Atmospheric pressure: 500hPa~1060hPa
Operating Environment
a) Temperature:+5 ℃~+40℃
b) Relative Humidity: ≤90%
c) Atmospheric pressure: 700hPa~1060hPa
1.4 Precautions
1.4.1 Attention
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 the device is carried from cold environment to warm or humid environment,
please do not use it immediately, wait four hours at least is recommended.
If some unknown error appears during measuring, press button to reset it.
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 set the device to standby mode before cleaning and disinfecting.
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.
During measuring, when abnormal conditions appear, please pull out your finger and
reinsert it to measure again.
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 does not provide over-limit alarm function for SpO2and PR, so it is
inapplicable for using in the place where need such function.
The maximum temperature at the SpO2 probe -tissue interface should be less than 41℃
which is measured by the temperature tester.
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.
The device can not be used during charging.
If necessary, please visit our official website to get the information about SpO2probe
that can be used with this device.
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 3), 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 SpO2probe 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-
Please select medical power adapter to charge it, when connecting the special adapter
with the socket, make sure there is no shelter near the socket and it is easy to plug and
unplug, otherwise the power will not be cut off in time when necessary, causes damage.
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 users 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. Low-battery indication: low-battery indication appears when the battery voltage is
too low to work.
b. Automatic standby function.
c. Memory function.
d. The data measured can be upload to the terminal equipment by wireless mode.
e. Charging function.
4 Installation
4.1 Appearance
Figure 2 Appearance
USB interface: connect with USB cable or SpO2probe
Button: exit/enter the standby mode.
4.2 Installation of SpO2probe
Open the USB plug of the device, then insert the SpO2probe interface into the USB
port of the device.
4.3 Connection of USB cable
Open the USB plug of the device, insert the micro end into the interface of the device,
the other end to the power adapter.
4.4 Structure and accessories and software description
A. Structure: main unit, SpO2probe, USB cable, power adapter (optional) and
Bluetooth adapter (optional).
B. Accessories: one SpO2probe, one USB cable, one power adapter (optional), one
User Manual, Bluetooth adapter (optional).
Please check the device and accessories according to the list to avoid that the device
can not work normally.
C.Software description
Software name: CMS50S embedded software
Software specification: no
Release version: 2.0
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
5.1 Measurement
A. Insert the finger into the probe as shown in Figure 3.
Figure 3 Sketch map for finger placement
(The appearance of actual probe may be different with the one shown as Figure 3,
please refer to the actual probe.)
Note: when inserting the finger, the light emitting from the sensor must be
directly irradiated to the side of the fingernail.
Note: during measuring, do not shake the finger and keep quiet, not move.
A. Long press the Button to exit the standby mode.
B. The device measures and saves the data automatically, the data need to be
uploaded to PC for checking.
Note: please synchronize the time with the master device when using it for the
first time, refer to chapter 5.5 for relative operations.
5.2 Exit/enter standby mode
a. Under the standby state, long press the Button to exit from it.
b. Under non-memory state, long press the Button to enter the standby mode.
c. If the device has not stored data, it will automatically enter standby mode after 30
s; Button operation, Bluetooth communication and device charging can reset the
standby time.
5.3 Insufficient storage time
The device will prompt by LED when the memory space is full, memory space is not
enough to store 8 hours or battery power is not enough to test 8 hours. Refer to
section 5.7 for LED status.

5.4 Data storage
a. After inserting the finger, the device recognizes the data and starts storing
automatically; it will close storage automatically after pulling out the finger.
b. From the time for the first open of the storage, the data within 48h can be
automatically spliced into one segment of data.
c. After 48 hours, the device can not store the data.
5.5 Data upload
A. When no finger inserted, the bluetooth of the device is open, then the master
device can be connected with the device by Bluetooth.
B. The master device can realize such functions as time synchronization, data upload,
data delete, etc.
C. When the device is connected by Bluetooth, there is a blue LED for indicating,
refer to 5. for LED state.
5.6 Charging
A. Power adapter can be selected to charge for the device.
B. Under charging state, it indicates that the device is charging when the indicator is
yellow, it is fully charged when it is green.
5.7 Description for device state
Status
LED
color
Flicker
frequency
Status meaning
Charge
Yellow
Light always
Charging.
Green
Light always
Charging completed.
Bluetooth
connection
Blue
Flicker
Transmitting, flicker frequency
automatically changes with data rate.
Blue
Light always
Bluetooth has been connected.
Non-charging,
non-memory,
non-Bluetooth
connection
Green
Light always
It displays green after power on, which
indicates that there is no memory and
power, etc.
Green
Flicker
The valid SpO2data is detected, start
recording and flicker 3 times, then the
LED is off.
Yellow
Flicker
Memory space is not enough to store 8
hours.
Red
Light always
Probe fault.
Red
Flicker
Battery power is not enough to test 8
hours.
Memory
Yellow
Flicker 3
times
Memory full, enter standby mode after
flickering 3 times.
Red
Flicker 3
times
Low power, enter standby mode after
flickering 3 times.
Red
Light always
Probe fault.
6 Maintain, Transport and Storage
6.1 Cleaning and disinfection
The device must enter to the standby mode before cleaning, and it should not be
immersed into the liquid. Use 75% alcohol to wipe the device for disinfecting, 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 user’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 charge the battery in time when low battery appears.
D.Recharge the battery soon after over-discharge. The device should be recharged
every three months when it is not used for some time. It can extend the battery life
following this guidance.
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 finger can
not be
recognized.
correctly.
1) The finger is not properly
inserted.
2) The finger is shaking or the
user 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 user keep calm.
3) Please use the device in
normal environment.
4) Please contact the
after-sales.
The device can
not be turned on.
Low battery or the battery is
drained away.
The device works abnormally.
Please charge the battery.
Please contact the
after-sales.
The device can
not be used for
full time after
charge.
The battery is not charged fully.
The device works abnormally.
Please charge the battery.
Please contact the
after-sales.
The battery can
not be fully
charged even
after 10-hour
charging time.
The device works abnormally.
Please contact the
after-sales.
The data can not
be stored.
The device is not operated
according to the manual.
The device works abnormally.
Please operate the device
according to the manual.
Please contact the
after-sales.
8 Key of Symbols
Symbols
Meaning
Symbols
Meaning
Refer to instruction
manual/booklet
Type BF applied part
No alarm
Bluetooth icon
IP22
International
Protection
Recyclable
Battery anode
Battery cathode
Manufacturer
Use-by date
Temperature
limitation.
Humidity limitation.
Atmospheric
pressure limitation.
This way up.
Fragile, handle with
care.
Keep away from rain.
Serial number
Exit/enter standby mode
Sensor
Off
The probe is
disconnected.
Sensor
Fault
Probe failure
Date of manufacture
WEEE (2012/19/EU)
P/N
Material code
LOT
Batch No.
PRbpm
Pulse rate (bpm)
%SpO2
Pulse oxygen saturation (%)
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/EC.
NOte：Your device may not contain all the following symbols.
9 Specification
SpO2[see note 1]
Displayed range
0%~99% (work with Smart Device Assistant)
Measured range
0%~100%
Accuracy[see note 2]
70% ~ 00%: ±2%;
0% ~ 69%: unspecified.
Resolution
1%
PR
Displayed range
30 bpm ~ 250 bpm
(work with Smart Device Assistant)
Measured range
30 bpm ~ 250 bpm
Accuracy[see note 3]
±2 bpm or ±2%, whichever is greater
Resolution
1 bpm
Low perfusion[see note 4]
Low perfusion 0.4%:
SpO2: ±4%;
PR: ±2 bpm or ±2%, whichever is greater
Light interference
Compared the value measured in room light and
existing lighting with the value measured under
darkroom conditions, deviation: ≤ 1%
Optical sensor[see note 5]
Red light
Wavelength: about 660 nm, optical output power:
<6.65 mW
Infrared light
Wavelength: about 905 nm, optical output power:
<6.75 mW
Memory
Store about 48-hour data
Safety classification
Internally powered equipment, type BF applied part
International Protection
IP22
Working voltage
DC 3.6 V ~ 4.2 V
Working current
≤100 mA
Power supply
A rechargeable lithium battery (3.7V) (The red wire
on the battery denotes anode, the black wire on the
battery denotes cathode.)
Battery working life
Charge and discharge: no less than 500 times.
Adapter specification
Output voltage: DC 5V
Output current: 1000 mA
Dimension and Weight
Dimension
46 mm(L) × 26 mm(W) × 11.5 mm(H)
Weight
About 22 g (including a lithium battery)
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: 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.
Note 4: 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 5: 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.
Appendix 1 EMC Guidance and Manufacturer Declaration
Table 1:
Guidance and manufacturer’s declaration –electromagnetic emission
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
purchaser or the user of the device should assure that it is used in such environment.
Emission test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Table 2:
Guidance and manufacturer’s declaration-electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
purchaser or the user of the Pulse Oximeter should assure that it is used in such environment.
Immunity test
IEC60601 test level
Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
±15kV air
Power frequency (50 / 60Hz)
magnetic field
IEC 61000-4-8
30 A/m
30A/m
Table 3:
Guidance and manufacturer’s declaration – electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
customer the user of the Pulse Oximeter should assure that it is used in such environment.
Immunity test
IEC 60601 test level
Compliance level
Radiated RF
IEC61000-4-3
10 V/m 80 MHz- 2.7 GHz
10 V/m80 MHz- 2.7 GHz
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 reflection from structures, objects and people.
a Field strengths from fixed 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
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the Pulse 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.
Table 4：
Guidance and manufacturer’s declaration - electromagnetic Immunity
The [Code SI] is intended for use in the electromagnetic environment specified below.
The customer or the user of the Pulse Oximeter should assure that it is used in such an
environment
Radiated
RF
IEC6100
0-4-3
(Test
specifica
tions for
ENCLO
SURE
PORT
IMMUN
ITY to
RF
wireless
communi
cations
equipme
nt)
Test
Freque
ncy
(MHz)
Band
a)
(MHz)
Service a)
Modulati
on b)
Mod
ulati
on
b)
(W)
Distan
ce
(m)
IMMUNIT
Y
TEST
LEVEL
(V/m)
385
380
–390
TETRA 400
Pulse
modulatio
n b)
18 Hz
1,8
0,3
27
450
380
–390
GMRS 460,
FRS 460
FM c)
± 5 kHz
deviation
1 kHz
sine
2
0,3
28
710
704
–787
LTE Band
13,17
Pulse
modulatio
n b)
217 Hz
0,2
0,3
9
745
780
810
800
–960
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulatio
n b)
18 Hz
2
0,3
28
870
930
1720
1700
–1990
GSM 1800;
CDMA
1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4, 25; UMTS
Pulse
modulatio
n b)
217 Hz
2
0,3
28
1845
1970
2450
2400
–2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulatio
n b)
217 Hz
2
0,3
28
5240
5100
–5800
WLAN
802.11
a/n
Pulse
modulatio
n b)
217 Hz
0,2
0,3
9
5500
5785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between
the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to
1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because
while it does not represent actual modulation, it would be worst case.
The MANUFACTURER should consider reducing the minimum separation distance, based on
RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate
for the reduced minimum separation distance. Minimum separation
distances for higher IMMUNITY TEST LEVELS shall be calculated using the
following equation:
P
d
6
E
Where P is the maximum power in W, d is the minimum separation distance in m,
and E is the IMMUNITY TEST LEVEL in V/m.
Warning
A. Don’t near active HF SURGICAL EQUIPMENT and the RF shielded room of an
ME SYSTEM for magnetic resonance imaging, where the intensity of EM
DISTURBANCES is high.
B. Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they are
operating normally.
C. Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.”
D. Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the device including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
E. Active medical devices are subject to special EMC precautions and they must be
installed and used in accordance with these guidelines.
Note：
When the device is disturbed, the data measured may fluctuate, please measure
repeatedly or in another environment to ensure its accuracy.
Bulethooth Specification
Working frequency: 2402 MHz ~ 2480 MHz
Modulation mode: GFSK
Transmitting power: 0 dBm, +4 dBm
Receiving sensitivity: -93 dBm

Hereby, Contec Medical Systems Co., Ltd. declares that the radio equipment type
CMS50S is in compliance with Directive 2014/53/EU
And the full Doc please see the attachment DOC Letter
FCC Caution.
§ 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.
The device has been evaluated to meet general RF exposure requirement. The device
can be used in portable exposure condition without restriction