Contec CMS50DA User manual

CMS50DA 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
CMS2.782.027(ZD)(OCH)ESS
Instructions to User
Dear Users, thank you very much for purchasing our product.
In case of modifications and software upgrades, the information contained in
this document is subject to change without notice.
The Manual describes, in accordance with the Pulse Oximeter'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 Manual very carefully before using this equipment. These
instructions describe the operating procedures to be followed strictly, failure to
follow these instructions can cause measuring abnormality, equipment damage
and personal injury. The manufacturer is NOT responsible for the safety,
reliability and performance issues and any monitoring abnormality, personal
injury and equipment damage due to user's 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 can be used repeatedly. Its using life is 3 years.
If you have any questions regarding to the use of this product, please call us at
1-847-979-9008 Monday-Friday from 8:00 AM to 5:00 PM Eastern Time.
WARNING:
The uncomfortable or painful feeling may appear if using the device
ceaselessly, especially for the microcirculation barrier users. It is
recommended that the sensor should not be applied to the same finger
for over 2 hours.
For the individual users, there should be a more prudent inspecting in
the placing process. The device can not be clipped on the edema and
tender tissue.
The light (the infrared is invisible) emitted from the device is harmful
to the eyes, so the user and the maintenance man, can not stare at the
light.
User can not use enamel or other makeup.
User’s fingernail can not be too long.
Please peruse the relative content about the clinical restrictions and
caution.
This device is not intended for treatment.
The User Manual is published by our company. All rights reserved.
1 Safety
1.1 Instructions for Safe Operations
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 about cables and transducers. It is recommended that the
device should be inspected once a week at least. When there is obvious
damage, stop using the oximeter.
Necessary maintenance must be performed by qualified service engineers
ONLY. Users are not permitted to maintain it by themselves.
The oximeter cannot be used together with devices not specified in User's
Manual.Only the accessory that appointed or recommendatory by
manufacture can be used with this device.
This product is calibrated before leaving factory.
1.2 Warnings
Explosive hazard—DO NOT use the oximeter in environment with
inflammable gas such as some ignitable anesthetic agents.
The person who is allergic to rubber can not use this device.
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.
Please check the packing before use to make sure the device and
accessories are totally in accordance with the packing list, or else the
device may have the possibility of working abnormally.
Please don't measure this device with function test paper for the device's
related information.
Parts of the device that are not serviced or maintained while in use with the
user.
Warning against servicing and maintenance while the me equipment is in
use.
No modification of this equipment is allowed.
The user is an intended operator.
The probe of the device is the applied part.
1.3 Attentions
Keep the oximeter away from dust, vibration, corrosive substances,
explosive materials, high temperature and moisture.
If the oximeter gets wet, please stop operating it.
When it is carried from cold environment to warm or humid environment,
please do not use it immediately.
DO NOT operate keys on front panel with sharp materials.
High temperature or high pressure steam disinfection of the oximeter is not
permitted. Refer to User Manual in the relative chapter for instructions of
cleaning and disinfection.
Do not have the oximeter immerged in liquid. When it needs cleaning, please
wipe its surface with medical alcohol by soft material. Do not spray any liquid
on the device directly.
When cleaning the device with water, the temperature should be lower than
60 ℃.
As to the fingers which are too thin or too cold, it would probably affect the
normal measure of the users' SpO2and pulse rate, please clip the thick finger
such as thumb and middle finger deeply enough into the probe.
Do not use the device on infant or neonatal user.
The product is suitable for adults (Weight should be between 40 kg to 110 kg).
The device may not work for all users. If you are unable to achieve stable
readings, discontinue use.
The update period of data is less than 5 seconds, which is changeable according
to different individual pulse rate.
The waveform is normalized.Please read the measured value when the
waveform on screen is equably and steady-going, Here this measured value is
optimal value. And the waveform at the moment is the standard one.
If some abnormal conditions appear on the screen during test process, pull out
the finger and reinsert to restore normal use.
The hanging rope attached the product is made from Non- allergy material, if
particular group are sensitive to the hanging rope, stop using it. In addition, pay
attention to the use of the hanging rope , do not wear it around the neck avoiding
cause harm to the user.
The instrument dose not have low-voltage alarm function, it only shows the
low-voltage.please change the battery when the battery energy is used out.
When the parameter is particularly, The instrument dose not have alarm
function.Do not use the device in situations where alarms are required.
Batteries must be removed if the device is going to be stored for more than one
month, or else batteries may leak.
A flexible circuit connects the two parts of the device. Do not twist or pull on
the connection.
1.4.Indication for Use
The Pulse Oximeter is a non-invasive device intended for the spot-check of
saturation of arterial hemoglobin(SpO2) and the pulse rate of adult in home use
environments.This device is not intended for continuous monitoring.The device can
be multi-used.Solely for use with sporting and aviation activities.Intended to monitor
heart rate during exercise.
2 Overview
The pulse 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 bio-parameter for the
respiration. For the purpose of measuring the SpO2more easily and accurately, our
company developed the Pulse Oximeter. At the same time, the device can measure
the pulse rate simultaneously.
The Pulse Oximeter features in small volume, low power consumption, convenient
operation and being portable. It is only necessary for user to put one of his fingers
into a fingertip photoelectric sensor for diagnosis, and a display screen will directly
show measured value of Hemoglobin Saturation.
2.1 Features
Operation of the product is simple and convenient.
The product is small in volume, light in weight (total weight is about 50g
including batteries) and convenient in carrying.
Power consumption of the product is low and the two originally equipped AAA
batteries can be operated continuously for 20 hours.
The product will automatically be powered off when no signal is in the product
within 5 seconds.
The product will enter standby mode when no signal is in the product within 5
seconds.
Display direction can be changed automatically,easy to view.
2.2 MajorApplications and Scope ofApplication
The Pulse Oximeter can be used in measuring pulse oxygen saturation and pulse rate
through finger. The product is suitable for family use(It can be used before or after
doing sports, and it is not recommended to use the device during the process of
doing sport) .
The problem of overrating would emerge when the user is suffering
from toxicosis which caused by carbon monoxide, the device is not
recommended to be used under this circumstance.
2.3 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 hP a~ 1060 hPa
3 Principle and Caution
3.1 Principle of Measurement
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 instrument 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.
Figure 1 Operating principle
3.2 Caution
1. The finger should be placed properly (see the attached illustration of this
manual, Figure 7), or else it may cause inaccurate measurement.
2. The SpO2sensor and photoelectric receiving tube should be arranged in a way
with the subject’s arteriole in a position there between．
3. The SpO2sensor should not be used at a location or limb tied with arterial canal
or blood pressure cuff or receiving intravenous injection.
4. Make sure the optical path is free from any optical obstacles like rubberized
fabric.
5. Excessive ambient light may affect the measuring result. It includes fluorescent
lamp, dual ruby light, infrared heater, direct sunlight and etc.
6. Strenuous action of the subject or extreme electrosurgical interference may also
affect the accuracy.
7. User can not use enamel or other makeup.
3.3 Clinical Restrictions
1. 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.
2. 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 SpO2determination by this monitor may be inaccurate.
3. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may
also be a major factor blamed for serious error of SpO2measure.
4. As the SpO2value serves as a reference value for judgement of anemic anoxia
and toxic anoxia, some users with serious anemia may also report good SpO2
measurement.
4 Technical Specifications
1) Display Format: LCD Display;
SpO2Measuring Range: 0% ~ 100%;
Pulse Rate Measuring Range: 30 bpm ~ 250 bpm;
Pulse Wave Display: columniation display and the waveform display.
2) Power Requirements: 2×1.5 V AAA alkaline battery (or using the
rechargeable battery instead), adaptable range: 2.6 V - 3.6 V.
3) Power Consumption: Smaller than 30 mA.
4) Resolution: 1% for SpO2and 1 bpm for Pulse Rate.
5) Measurement Accuracy: ±2% in stage of 70% - 100% SpO2, and meaningless
when stage being smaller than 70%. ±2 bpm during the pulse rate range of 30 -
99 bpm and ±2% during the pulse rate range of 100 ~ 250 bpm . Clinical
Trial :SpO2regression plot & Bland–Altman plot,Refer to Figure 2 & Figure 3.
6) Measurement Performance in Weak Filling Condition: SpO2and pulse rate
can be shown correctly when pulse-filling ratio is 0.4%. SpO2error is ±4%,
pulse rate error is ±2 bpm during the pulse rate range of 30 ~ 99 bpm and ±2%
during the pulse rate range of 100 ~ 250 bpm .
7) Resistance to surrounding light: The deviation between the value measured in
the condition of man-made light or indoor natural light and darkroom is less
than ±1%.
8) It is equipped with a function switch: The product will enter standby mode
when no signal is in the product within 5 seconds.
9) Optical Sensor
Red light (wavelength is 660 nm, 6.65 mW)
Infrared (wavelength is 880 nm, 6.75 mW)
Figure 2 SpO2regression plot
Figure 3 Bland–Altman plot
5 Accessories
One hanging rope;
Two batteries(optional)
One User Manual.
6 Installation
6.1 View of the Front Panel
Figure 4 Front view
Figure 5 Batteries installation
6.2 Battery
Step 1. Refer to Figure 5. and insert the two AAA size batteries properly in the
right direction.
Step 2. Put back the cover.
Please take care when you insert the batteries for the improper
insertion may damage the device.
6.3 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 6 Mounting the hanging rope

Figure 7 Put finger in position
7 Operating Guide
1) Insert the two batteries properly to the direction, and then replace the cover.
2) Open the clip as shown in Figure 7.
3) Let the user’s finger put into the rubber cushions of the clip (make sure the
finger is in the right position), and then clip the finger.
4) Press the switch button once on front panel.
5) Do not shake the finger and keep the user at ease during the process.
Meanwhile, human body is not recommended in movement status.
6) Get the information directly from screen display.
7) The button has two functions.When the device is in standby mode, pressing
the button can exit it; When the device is in operation status, pressing the button
long can change brightness of the screen.
8) The device could change display direction according to the handing
direction.
Fingernails and the luminescent tube should be on the same side.
8 Repairing and Maintenance
Please change the batteries when the low-voltage displayed on the screen.
Please clean the surface of the device before using. Wipe the device with
medical alcohol first, and then let it dry in air or clean it by dry clean
fabric.
Using the medical alcohol to disinfect the product after use, prevent from
cross infection for next time use.
Please take out the batteries if the oximeter is not in use for a long time.
The packed device can be transported by ordinary conveyance or according
to transport contract.The device can not be transported mixed with toxic,
harmful, corrosive material.
The best storage environment of the device is - 40ºC to 60ºC ambient
temperature and not higher than 95% relative humidity.
Users are advised to calibrate the device termly (or according to the
calibrating program of hospital). It also can be performed at the
state-appointed agent or just contact us for calibration.
High-pressure sterilization cannot be used on the device.
Do not immerse the device in liquid.
It is recommended that the device should be kept in a dry
environment. Humidity may reduce the useful life of the device, or
even damage it.
9 Troubleshooting
Trouble
Possible Reason
Solution
The SpO2and
Pulse Rate
can not be
displayed
normally
1. The finger is not properly
positioned.
2. The user’s SpO2is too
low to be detected.
1. Place the finger
properly and try again.
2. Try again; Go to a
hospital for a diagnosis
if you are sure the
device works all right.
The SpO2and
Pulse Rate are
not displayed
stably
1. The finger is not placed
inside deep enough.
2. The finger is shaking or
the user is moving.
1. Place the finger
properly and try again.
2. Let the user keep
calm
The device
can not be
turned on
1. The batteries are drained
or almost drained.
2. The batteries are not
inserted properly.
3. The malfunction of the
device.
1. Change batteries.
2. Reinstall batteries.
3. Please contact the
local service center.
The display is
off suddenly
1. The product will enter
standby mode when no
signal is in the product
within 5 seconds
2. The batteries are almost
drained.
1. Normal.
2. Change batteries.
10 Key of Symbols
Symbol
Description
Type BF
Refer to instruction manual/booklet
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 negative electrode；
1.Exit standby mode.
2.Change brightness of the screen.
SN
Serial number
Alarm inhibit
WEEE (2002/96/EC)
IP22
International Protection
Manufacturer
Manufacture Date
Storage and Transport Temperature limitation
Storage and Transport Humidity limitation
Storage and Transport Atmospheric pressure limitation
This side up
Fragile, handle with care
Keep dry
Recyclable
11 Function Specification
Display Information
Display Mode
The Pulse Oxygen Saturation
(SpO2)
LCD
Pulse Rate (PR)
LCD
Pulse Intensity (bar-graph)
LCD bar-graph display
Pulse wave
LCD
SpO2Parameter Specification
Measuring range
0% ~ 100%, (the resolution is 1%).
Accuracy
70% ~ 100%:±2%, Below 70% unspecified.
Optical Sensor
Red light (wavelength is 660 nm)
Infrared (wavelength is 880 nm)
Pulse Parameter Specification
Measuring range
30 bpm ~ 250 bpm (the resolution is 1 bpm)
Accuracy
±2 bpm or±2% select larger
Pulse Intensity
Range
Continuous bar-graph display, the higher
display indicate the stronger pulse.
Battery Requirement
1.5V (AAA size) alkaline batteries ×2 or rechargeable battery
Battery Useful Life
Two batteries can work continually for 20 hours
Dimensions and Weight
Dimensions
57(L) ×31(W) ×32(H) mm
Weight
About 50 g (with the batteries)
Appendix
Guidance and manufacture’s declaration-electromagnetic emission
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration –electromagnetic emission
The CMS50DA Pulse Oximeter is tended for use in the electromagnetic
environment specified below. The customer of the user of the CMS50DA Pulse
Oximeter should assure that it isused in such an environment.
Emission test
compliance
Electromagnetic
environment-guidance
RF emissions
CISPR 11
Group 1
The CMS50DA Pulse Oximeter uses RF
energy only for their 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
Class B
The CMS50DA 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.
Harmonic
emissions
IEC 61000-3-2
Not
applicable
Voltage
fluctuations/
flicker emission
IEC 61000-3-3
Not
applicable
Guidance and manufacture’s declaration-electromagnetic immunity
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration-electromagnetic immunity
The CMS50DA Pulse Oximeter is intended for use in the electromagnetic
environment specified specified below. The the user of CMS50DA Pulse
Oximeter should assure that it is used in such an environment.
Immunity
test
IEC60601 test
level
Compliance
level
Electromagnetic
environment-guidance
Electrostat
ic
discharge
(ESD) IEC
61000-4-2
±6KV contact
±8KV air
±6KV
contact
±8KV air
Floors should be wood,
concrete or ceramic tile.
If floor are covered with
synthetic material, the
relative humidity should
be at least 30%.
Power
frequency
(50Hz)
magnetic
field
IEC
61000-4-8
3A/m
3A/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 CMS50DA Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of CMS50DA Pulse
Oximeter should assure that it is used in such an environment.
Immunit
y test
IEC606
01 test
level
Complia
nce level
Electromagnetic environment
-guidance
Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM
for EQUIPMENT or SYSTEM that not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment and the CMS50DA
Pulse Oximeter
The CMS50DA Pulse Oximeter is intended for use in the electromagnetic
environment in which radiated RF disturbances are controlled. The customer or
the user of the CMS50DA Pulse Oximeter can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the CMS50DA 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)
150KHz to
80MHz
80MHz to
800MHz
800MHz to
2.5GHz
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed above, the
recommended separation distanced 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 80MHz and 800MHz, 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.
Radiat
ed RF
ICE
61000-
4-3
3V/m
80MH
z to
2.5GH
z
3V/m
Portable and mobile RF communication
equipment should be used no closer to any
part of the CMS50DA Pulse Oximeter,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
recommended separation distance
P
E
d






1
5.3
80MHz to 800MHz
P
E
d






1
7
800MHz to 2.5GHz
Where Pis the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and dis the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a should be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1 At 80MHz and 800MHz, 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 broadcastcannot 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 CMS50DA Pulse
Oximeter is used exceeds the applicable RF compliance level above, the
CMS50DA 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 CMS50DAPulse Oximeter.
b. Over the frequency range 150 KHz to 80 MHz, field strengths should be
less than 3V/m.
P
E
d






1
5.3
P
E
d






1
5.3
P
E
d






1
7

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.