Contec Medical Systems CMS50K Wearable SpO2/ECG Monitor User Manual

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Date Submitted	2016-06-08 00:00:00
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Content
1 Precautions ....................................................................................................................................... 1
1.1 General Precautions .............................................................................................................. 1
1.2 Measurement Precautions ..................................................................................................... 1
1.3 Safety Precautions ................................................................................................................. 2
1.4 EMC Statement .................................................................................................................... 2
2 Overview .......................................................................................................................................... 4
2.1 Features ................................................................................................................................. 4
2.2 Range of Application ............................................................................................................ 4
3 Main Technical Specification ........................................................................................................... 5
3.1 Environment Requirements................................................................................................... 5
3.2 Main Parameters ................................................................................................................... 5
3.3 Main Performance ................................................................................................................. 5
3.4 Product applied part .............................................................................................................. 5
4 Device Introduction.......................................................................................................................... 6
4.1 Appearance Introduction ....................................................................................................... 6
4.2 Interface Introduction ............................................................................................................ 6
5 Operation Instruction ....................................................................................................................... 7
5.1 Power On and Power Off ...................................................................................................... 7
5.2 SpO2 Measurement ............................................................................................................... 7
5.3 Pedometer ............................................................................................................................. 8
5.4 ECG Measurement ................................................................................................................ 8
5.5 Charge ................................................................................................................................... 8
5.6 Data Upload .......................................................................................................................... 8
5.7 The Installation and Replacement of SpO2 Probe ................................................................. 8
5.8 Accessories ............................................................................................................................ 9
5.9 Clinical Restrictions .............................................................................................................. 9
6 Troubleshooting ............................................................................................................................. 10
7 Maintenance&Transportation&Storage ......................................................................................... 11
7.1 Cleaning and Disinfecting ................................................................................................... 11
7.2 Maintenance ........................................................................................................................ 11
7.3 Transportation and Storage ................................................................................................. 11
8. Meaning of Symbol....................................................................................................................... 12
9. Specification ................................................................................................................................. 13
Instructions to User
Dear users, thank you very much for purchasing the CMS50K Wearable SpO2/ECG Monitor.
This Manual describes, in accordance with the product'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
equipment. Refer to the respective chapters for details.
Please read the User Manual carefully before using this product. The User Manual which describes
the operating procedures should be followed strictly. Failure to follow the User Manual may cause
measuring abnormality, equipment damage and human injury. The manufacturer is NOT
responsible for the safety, reliability and performance issues and any monitoring abnormality,
human injury and equipment 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.
This product is medical device, which can be used repeatedly.
This User Manual is compiled by our company. All rights reserved. Reproduction, adaption or
translation, for any part of the manual without prior written permission, is prohibited.
 Our company have the responsibility to provide qualified product which conform to company
standard of this product.
 Our company have the responsibility to complete product installation, debugging and technical
training according to the contract.
 Our company have the responsibility to complete product maintenance according to the
contract.
 Our company have the responsibility to respond the requirements of user in time.
Note: before using this product, please read the User Manual carefully.
II
1 Precautions
1.1 General Precautions
1)
Do not use the product in high temperature or high humidity environment, the operating
temperature of the product is 10˚C~40˚C, the operating humidity of the product is
0%~75%RH.
2) Do not clean the product with water, if the device gets wet, please stop operating it.
3) When the device is carried from cold environment to warm or humid environment, please
do not use it immediately.
4) Do not use or store the product in the following conditions:
 areas near flame or fire;
 areas with strong shock;
 areas with strong electromagnetic field.
5) Do not disinfect the product in autoclaves or gas sterilizer.
6) The device has useful life for five years, when the device reach the end of life and can not
be used, please do not discard it at will, the disposal should follow the local laws and
regulations.
7) Keep the operation environment away from dust, vibration, corrosive substances,
explosive materials, high temperature and humidity.
8) Strenuous action of the subject or extreme electrosurgical interference may affect the
accuracy.
9) After using, refer to the relative chapter(7.1) in User Manual for instructions of cleaning
and disinfection.
10) The device is worn on the arm, fixed position, too tight or too loose will affect the
measurement accuracy.
11) Please don't measure this device with functional tester for the device's related
information.
12) Please don't use the device during MRI or CT scanning.
13) The disposal of scrap instrument and its accessories and packings(including battery,
plastic bags, foams and paper boxes) should follow the local laws and regulations.
14) The user must check that the equipment functions safely and see that it is in proper
working condition before being used.
15) The patient is an intended operator.
16) A warning against servicing and maintenance while the ME equipment is in use.
1.2 Measurement Precautions
1)
2)
3)
4)
If subjects' skin is too dry to measure ECG, wipe them with disinfectant alcohol or
electric salve so that the electric capability can be strengthened.
When measuring ECG, the subject should maintain a natural sitting posture with a
straight back, and begin to measure after the waveform is stable.
When measuring ECG, the finger and arm electrodes should touch subjects' skin exactly,
roundly and well.
When measuring SpO2, the subject should entirely put a finger into the black pane on the
5)
6)
7)
side of the device, the finger entirely touch the contact.
During exercise, it is not suitable for measuring ECG and SpO2.
The device can only be matched with the compatible probe.
The product is not suitable for use in continuous supervision for patients. The problem of
overrating would emerge when the patient is suffering from toxicosis which caused by
carbon monoxide, the device is not recommended to be used under this circumstance.
1.3 Safety Precautions
1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
Do not use the device under the state of charging.
No servicing and maintenance while the ME equipment is in use
When the device is not used for a long time, it should be placed in a cool, dry room, and
power it every three month.
Do not use the device in environment with inflammable gas such as some ignitable
anesthetic agents.
The infrared is harmful to eyes, so the user and the maintenance man should not stare at
the light part of the SpO2 probe (the infrared is invisible).
Inspect periodically, 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 at least once a week. Please stop using the oximeter if there is obvious damage
to the device.
When measuring SpO2 with probe, subjects can not use enamel or other makeup.
Please refer to the correlative medicinal literature about the clinical restrictions and
contraindications.
The disposal of scrap instrument and its accessories and packings(including battery,
plastic bags, foams and paper boxes) should follow the local laws and regulations.
Necessary maintenance must be performed by qualified service engineers ONLY. Users
are not permitted to maintain it by themselves.
The device cannot be used together with equipments not specified in User’s Manual.
Only the accessory that is appointed or recommendatory by manufacture can be used
with this device.
The device is not intended for treatment.
The device has been calibrated before leaving factory.
1.4 EMC Statement
1)
When using the device, EMC should be paid more attention, the device shall be used in
the environment complied with the appended table.
FCC Cautions:
1)
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.
2)
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.
3)
Any Changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate the equipment.
4) The device has been evaluated to meet general RF exposure requirement. The device can
be used in portable exposure condition without restriction.
2 Overview
CMS50K Wearable SpO2/ECG Monitor integrated functions of SpO2, ECG and pedometer in one
product.
The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2
concentration in the blood. It is an important bio-parameter for the respiration. A number of
diseases relating to respiratory system may cause the decrease of SpO2 in 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' SpO2 is of great help for the doctor to discover the
potential danger, and is of great importance in the clinical medical field.
The ECG function of CMS50K Wearable SpO2/ECG Monitor is a good helper in the prevention of
cardiovascular disease, as it can monitor ECG with easy operation at any time and any place. The
device can record, analyze and display users' ECG waveform, capture the pathological ECG
waveform when users happen to transient heart attack or other unpleasant symptoms. The heart can
be monitored not limited in the hospital, which saves money from the physical check-up for users.
After connecting with a computer or APP in mobile phone, the device can provides data reference
for doctors.
The pedometer function of CMS50K Wearable SpO2/ECG Monitor is basing on counting steps by
acceleration sensor, adopts the recognition principle of pace waveform and its acceleration and
deceleration process for recognizing the waveform produced by person walking, finally gets the
number of steps. Detailed method: use the acceleration sensor to collect user’s steps(more than five
steps), via analyzing and calculating, obtain the peak value of step vibration waveform and the
average value of acceleration difference value, and set it to the threshold value. Collect the user’s
actual step waveform data, if it is in the threshold range, then it is considered that user walks one
step forward.
2.1 Features
1)
2)
3)
Compact shape, handsome appearance, easy to operate and carry.
Monitor and record real-time SpO2 value, pulse rate value, ECG waveform, heart rate,
step number and calories anytime and anywhere.
With real-time clock function, the device can display year, month, day, hour, minute and
second, it can be used as an electronic clock when there is no measurement activities.
2.2 Range of Application
1)
2)
3)
Applicable situations: the device applies to family, medical clinics and hospitals, and
can't be used for clinic medical examination instead of conventional electrocardiograph.
Applicable object: people under high pressure and workload for long time, heart disease
patients, the elderly and sub-health people.(The patient is an intended operator)
Purpose: the device does not belong to the therapy equipment, it is just for the
measurement and storage of SpO2, ECG and step number at anytime and anywhere.
Operation is simple and less requirement for the operating personnel.
3 Main Technical Specification
3.1 Environment Requirements
1)
Operating environment

Temperature: 10˚C~40˚C

Relative humidity: 0%~75%RH

Power supply: built-in rechargeable lithium batteries, voltage is 3.7V
2)
Transport and storage environment

Temperature: -40˚C~+55˚C

Relative humidity: ≤95%
3.2 Main Parameters
1)
2)
Measurement range of SpO2: 0%~100%, error: 70%~100%: ±2%; 0%~69%: unspecified.
Measurement range of pulse rate: 30bpm~250bpm, error: ±2bpm or ±2%(select the
larger).
3) Measurement range of heart rate: 30bpm~300bpm, display error is ±1bpm or 1%(select
the larger);
4) The software revision level is V0.94, release date is Oct.19，2015.
5) The type of protection against electroshock: internally powered equipment;
6) The degree of protection against electroshock: type BF applied part;
7) The grade of protection against ingress of liquid: IP54;
8) Sterilization or disinfection: N/A
9) Category AP / APG equipment: N/A;
10) Mode of operation: Continuous.
3.3 Main Performance
1)
2)
3)
4)
5)
6)
7)
8)
9)
Display of SpO2 value.
Display of pulse rate value.
Display of heart rate value and ECG waveform.
Display of step number and calorie.
Low-battery indication.
Data storage function.
The data stored can be wireless uploaded to mobile terminal.
Clock function.
Charging function.
3.4 Product applied part
Name：ECG electrode slices 、lower shell、Watchband
Material: stainless steel, plastic, silica gel
BF applied type: type BF
4 Device Introduction
4.1 Appearance Introduction
Watchband
button
Charging interface/
SpO2 probe interface
The touch area
when measuring
SpO2
Figure 4-1
Figure 4-2
4.2 Interface Introduction
Wireless icon
Date
Battery icon
Time
Calories
Step number
Figure 4-3 Pedometer interface
Battery icon
ECG icon
Heart rate icon
Heart rate value
ECG waveform
Figure 4-4 ECG measurement interface
SpO2 icon
Pulse rate icon
Bar graph indicator
SpO2 value
Pulse rate value
SpO2 waveform
Figure 4-5 SpO2 measurement interface
5 Operation Instruction
5.1 Power On and Power Off
For blank screen, press the button to turn on the device. In the state of power-on, the device
will automatically enter the power-down mode if there is no operation for a while.
5.2 SpO2 Measurement
After turning on the device, press the button to switch the device to the SpO2 measurement
interface, put a finger into the SpO2 measurement area(as Figure 5-1) and fully touch the contact,
then the SpO2 value can be measured.
SpO2 measurement area
Figure 5-1 Measure SpO2 through touching
After inserting the external probe into the USB interface on the left side of the device, insert a
finger into the probe, then the SpO2 value also can be measured, as Figure5-2.
Figure5-2 Measure SpO2 through the external probe
5.3 Pedometer
Press the button to switch the device to the pedometer interface(as Figure4-3). In the
pedometer interface, users can measure step number and calorie, long press the button to begin the
pedometer, long press the button again to end the pedometer. Users can view the date and time in
this interface, and the device can automatically synchronize date and time when connecting with
mobile phone APP.
5.4 ECG Measurement
Press the button to switch the device to the ECG measurement interface(as Figure4-4), after
wearing the device, two ECG electrode slices(as Figure5-3) on the back of the device will fully
contact with the arm, the ECG can be measured when a part(usually is a finger) of the body contact
with the metal electrode slice(as Figure5-4) on the upper shell of the device.
ECG electrode slices
on the back of the
device
Metal electrode slices
on the upper shell
Figure 5-3
Figure 5-4
The device will switch to pedometer interface after the body left the metal electrode slice on the
upper shell.
5.5 Charge
Connect the device to an adapter (output current>500mA, 5V, general USB interface) complied
with IEC 60950-1 at least, and it will take about 2~3 hours to complete charging.
5.6 Data Upload
After connecting with mobile phone APP, the device can automatically synchronize time, store and
send values of SpO2, pulse rate, heart rate, ECG waveform, step number and calorie to mobile
phone client.
5.7 The Installation and Replacement of SpO2 Probe
After inserting the external probe(as Figure5-5) into the USB interface on the left side of the device,
the installation is completed.(as Figure5-2)
Figure 5-5 External SpO2 probe
5.8 Accessories




A unit of CMS50K Wearable SpO2/ECG Monitor
Three external SpO2 probe
A User Manual
A data cable
5.9 Clinical Restrictions
1)
2)
3)
4)
As the SpO2 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 SpO2 waveform (PLETH)
will decrease. In this case, the measurement will be more sensitive to interference.
For those with a substantial amount of staining dilution drug (such as methylene blue, indigo
green and acid indigo blue), or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb)
or thiosalicylic hemoglobin, and some with icterus problem, the SpO2 determination by this
device may be inaccurate.
The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major
factor resulted in serious error of SpO2 measure.
The SpO2 value serves as a reference value for judgment of anemic anoxia and toxic anoxia,
for some patients with serious anemia may also report good SpO2 measurement.
6 Troubleshooting
If there is something wrong with the device, you can solve it according to the following table, if the
problem not included in the following table and you can not solve it either, please contact with the
customer service.
Problem
Cause
Battery is exhausted.
the device cannot be woke up
again after appearing blank
screen during use.
The disturbance is too big or the
waveform is random in ECG
sampling process.
The SpO2 or Pulse Rate cannot
be displayed normally.
The display disappears
suddenly.
Solution
Please charge the device.
The finger is not properly
touch the contact on the side
of the device.
Make the finger well touch
the contact on the side of the
device
Misoperation
Only touch the contact on side
can wake up the device after
appearing blank screen.
Your skin is dry.
Wipe skin with disinfectant
alcohol or electric salve.
There is unwanted
movement in sampling
process.
Please sit comfortably, and
touch the electrode gently, do
not squeeze the electrode.
There is strong
electromagnetic disturbance
in sampling environment.
Please turn off interference
source or resample in
environment without strong
electromagnetic field.
The finger is not properly
touch the contact on the side
of the device.
Put the finger properly and try
again.
The SpO2 value of patient is
too low to be detected.
Please try several times more;
Go to a hospital for a
diagnosis if you are sure the
device works all right.
Low power
Please charge the device in
time.
The device enters to standby
mode automatically if there
is no measurement for 1
minute.
Normal
10
7 Maintenance & Transportation & Storage
7.1 Cleaning and Disinfecting
Turn off the device before cleaning. Use medical ethanol to clean and disinfect the device, natural
air-drying or clean it with a clean and dry cloth. Avoid any liquid entering to the device.
7.2 Maintenance
1)
Any person who is not authorized by our company, could not open the enclosure of the
device to avoid possible damage to internal components.
2) Any maintains and upgrades to this device must be carried out by personnel trained and
authorized by our company.
3) Prevent any liquid from seeping into the device as it will affect the safety and
performance of the device.
4) Avoid tempestuously vibration or hit when using the device.
5) Do not place other objects on the device, this could damage the touch screen.
6) Keep the device away from dust, high temperature and humidity, and avoid strong
shaking and hitting.
7) If there are foreign bodies sticked on the surface of the device, please wipe it with neutral
detergent, avoid using strong corrosive liquid, like alcohol and gasoline, etc.
8) Please clean and disinfect the device before using according to the User Manual (7.1).
9) Please charge the device in time when low-battery appears.
10) The device needs to be calibrated periodically (or according to the calibrating program of
hospital). It also can be performed at the state-appointed agent or just contact us for
calibration.
7.3 Transportation and Storage
1)
2)
The packed device can be transported by general vehicle or according to the order
contract, avoid pounded, shake and splash by rain and snow in transportation.
The packed device should be stored in room with no corrosive gases and good ventilation.
Temperature: -40°C~+55°C; Relative Humidity: ≤95%; Atmospheric pressure:
500hPa~1060hPa.
11
8. Meaning of Symbol
Symbol
Meaning
Refer to instruction manual/booklet
The pulse oxygen saturation(%)
Pulse rate(bpm)
Low-power(please
measurement)
charge
in
time
to
ensure
the
accurate
Full-power
The bluetooth is ON
Heart rate
IP54
Ingress of liquids rank
Step number
Calories
Type BF applied part
ECG interface indicator
SN
Serial number
Alarm inhibit
WEEE (2002/96/EC)
European Representative
This item is compliant with Medical Device Directive 93/42/EEC of
June 14, 1993, a directive of the European Economic Community.
12
9. Specification
Display Information
Display Mode
The Pulse Oxygen Saturation(SpO2)
2-digit digital
OLED display
Pulse Rate(PR)
3-digit digital
OLED display
Heart rate
3-digit digital
OLED display
Pulse Intensity(bar-graph)
bar-graph
OLED display
Calorie
5-digit digital
OLED display
Step number
5-digit digital
OLED display
Time
Year-month-day hour-minute OLED display
SpO2 parameter
Display range
0%~99%(resolution: 1%)
Pulse parameter
Display range
30bpm~250bpm(resolution: 1bpm)
Pedometer
Display range
0~65535steps(resolution: one step)
Safety classification
Internally powered equipment, type BF applied part
Pulse Intensity
Range
Continuous bar-graph display, the higher display
indicates the stronger pulse.
Power supply
DC 3.7V
Dimension and weight
Dimension
50.4mm(L)*41.4mm(W)*14.7mm(H)
Weight
About 73g(not including accessories)
13
EMC Declaration
Guidance and manufacturer’s declaration – electromagnetic immunity
The CMS50K” is intended for use in the electromagnetic environment specified below. The customer or the user of
the “CMS50K” should ensure that it is used in such an environment.
IEC 60601
test level
Immunity test
Compliance
level
Electrostatic
6 kV contact
6 kV contact
discharge (ESD)
8 kV air
8 kV air
Electrical fast
2 kV for power
2 kV for power
transient/burst
supply lines
supply lines
IEC 61000-4-4
1 kV for input/output
1 kV for input/output
lines
lines
Surge
1 kV differential
1 kV differential
IEC 61000-4-5
mode
mode
2 kV common mode
2 kV common mode
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
<5 % UT
(>95 % dip in UT)
for 5 sec
3 A/m
3 A/m
IEC 61000-4-2
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
14
Electromagnetic environmentguidance
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30 %.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the “CMS50K” requires
continued operation during
power mains interruptions, it is
recommended that the
“CMS50K” be powered from an
uninterruptible power supply or
a battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
Guidance and manufacturer’s declaration – electromagnetic immunity
The “CMS50K” is intended for use in the electromagnetic environment specified below. The customer or the user of
the “CMS50K” should ensure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment – guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
“CMS50K”, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
d=1.2√P
3 Vrms
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2,5 GHz
3V
d=1.2√P
80MHz to 800MHz
d=2.3 √P
800MHz to 2.5 GHz
3 V/m
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, should be less than the compliance
level in each frequency range. 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 reflection from structures, objects and people.
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 “CMS50K” is
used exceeds the applicable RF compliance level above, the Medical CMS50K should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the “CMS50K”.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
Guidance and manufacturer’s declaration – electromagnetic emissions
The “CMS50K” is intended for use in the electromagnetic environment specified below. The customer or the
user of the “CMS50K” should ensure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
Group 1
The “CMS50K” uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
The “CMS50K” 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.
Class A
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
Complies
IEC 61000-3-3
Recommended separation distances between
portable and mobile RF communications equipment and the Medical CMS50K
The “CMS50K” is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Medical CMS50K can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the “CMS50K” as recommended below, according to the maximum output power of the communications
equipment.
Separation distance according to frequency of transmitter
Rated maximum output
power of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5
GHz
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (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.

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