MEDIPREVENTIECENTRUM Pulse Oximeter Specifications

Instructions to User
Dear Users, thank you very much for purchasing our product.
This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for
medical devices and harmonized standards. The Manual is written for the current Pulse Oximeter. 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 is medical device, and can be used repeatedly. Its using life is 3 years.
WARNING:
� The uncomfortable or painful feeling may appear if using the device ceaselessly, especially
for the microcirculation barrier patients. It is recommended that the sensor should not be
applied to the same finger for over 2 hours.
� For the individual patients, 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.
� Testee can not use enamel or other makeup.
� Testee
Testee’’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.
Caution: Federal law restricts this device to sale by or on the order of a physician
physician..
The User Manual is published by our company. All rights reserved.
1
Table of Contents
................................................................................................................................................. 3
1 Safety
Safety.................................................................................................................................................
1.1 Instructions for safe operations........................................................................................................... 3
1.2 Warnings............................................................................................................................................. 3
1.3 Attentions............................................................................................................................................3
1.4 Indication for Use............................................................................................................................... 4
........................................................................................................................................... 4
2 Overview
Overview...........................................................................................................................................
2.1 Classification...................................................................................................................................... 4
2.2 Features...............................................................................................................................................4
2.3 Major applications and scope of application.......................................................................................5
2.4 Environment requirements..................................................................................................................5
...................................................................................................................... 5
3 Principle and Caution
Caution......................................................................................................................
3.1 Principle of measurement................................................................................................................... 5
3.2 Caution................................................................................................................................................6
3.3 Clinical restrictions............................................................................................................................. 6
....................................................................................................................
6
4 Technical specifications
specifications....................................................................................................................
....................................................................................................................6
........................................................................................................................................ 7
5 Accessories
Accessories........................................................................................................................................
........................................................................................................................................ 7
6 Installation
Installation........................................................................................................................................
6.1 View of the front panel....................................................................................................................... 7
6.2 Battery................................................................................................................................................ 7
6.3 Mounting the hanging rope.................................................................................................................8
7 Operating Guide
...............................................................................................................................
8
Guide...............................................................................................................................
...............................................................................................................................8
.......................................................................................................... 10
8 Repairing and Maintenance
Maintenance..........................................................................................................
.............................................................................................................................. 11
9 Troubleshooting
Troubleshooting..............................................................................................................................
............................................................................................................................. 11
10 Key of Symbols
Symbols.............................................................................................................................
..................................................................................................................
12
11 Function Specification
Specification..................................................................................................................
..................................................................................................................12
............................................................................................................................................ 13
Appendix
Appendix............................................................................................................................................
2
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 patient’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 monitor.
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.
DO NOT use the oximeter while the testee measured by MRI and CT.
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.
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 patients' SpO2 and 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 patients.
The product is suitable for children above four years old and adults (Weight should be between
15kg to 110kg).
The device may not work for all patients. If you are unable to achieve stable readings,
3
␇
␇
␇
␇
␇
␇
␇
␇
␇
discontinue use.
The update period of data is less than 5 seconds, which is changeable according to different
individual pulse rate.
Please read the measured value when the waveform on screen is equably and steady-going,This
measured value is optimal value. And the waveform at the monment 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 device has normal useful life for three years since the first electrified 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 patient.
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 Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen
saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home
and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care
ect.). This device is not intended for continuous monitoring.
2 Overview
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. For the purpose of
measuring the SpO2 more 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 patient 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 Classification
Class II b, (MDD93/42/EEC
IX
Rule 10)
2.2 Features
�
�
�
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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.
4
�
�
4 directions display mode without waveform.
Waveform display mode as line drawing or filling manner.
2.3 Major applications and scope of application
The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through
finger, and indicate the pulse intensity by the bar-display. The product is suitable for use in family,
hospital (Ordinary sickroom), Oxygen Bar, social medical organizations and also the measure of
saturation oxygen and pulse rate.
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.
2.4 Environment requirements
Storage Environment
a) Temperature :-40℃~+60℃
b) Relative humidity :≦95%
c) Atmospheric pressure :500hPa~1060hPa
Operating Environment
a) Temperature :10℃~40℃
b) Relative Humidity :≦75%
c) Atmospheric pressure :700hPa~1060hPa
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
5
3.2 Caution
1.
2.
3.
4.
5.
6.
7.
The finger should be placed properly (see the attached illustration of this manual ,Figure 5), or
else it may cause inaccurate measurement.
The SpO2 sensor and photoelectric receiving tube should be arranged in a way with the
subject’s arteriole in a position there between.
The SpO2 sensor should not be used at a location or limb tied with arterial canal or blood
pressure cuff or receiving intravenous injection.
Make sure the optical path is free from any optical obstacles like rubberized fabric.
Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby
light, infrared heater, direct sunlight and etc.
Strenuous action of the subject or extreme electrosurgical interference may also affect the
accuracy.
Testee can not use enamel or other makeup.
3.3 Clinical restrictions
1.
2.
3.
4.
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 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
monitor may be inaccurate.
The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major
factor blamed for serious error of SpO2 measure.
As the SpO2 value serves as a reference value for judgement of anemic anoxia and toxic anoxia,
some patients with serious anemia may also report good SpO2 measurement.
4 Technical specifications
1) Display Format: OLED Display;
ing Range
SpO2 Measur
easuring
Range:: 0% ~ 100%;
ing Range
Pulse Rat
Ratee Measur
easuring
Range:: 30 bpm ~ 250 bpm;
Pulse Wave Display: columniation display and the waveform display.
2) Power Requirements: 2 ×1.5V AAA alkaline battery (or using the rechargeable battery
instead), adaptable range: 2.6V~3.6V.
3) Power Consumption: Smaller than 30mA.
4) Resolution: 1% for SpO2 and 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 .
6) Measurement Performance in Weak Filling Condition: SpO2 and pulse rate can be shown
correctly when pulse-filling ratio is 0.4%. SpO2 error 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
6
of man-made light or indoor natural light and that of darkroom is less than ±1%.
8) It is equipped with a function switch. The Oximeter can be powered off in case no finger is the
Oximeter within 5 seconds.
9) Optical Sensor
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
5 Accessories
�
�
�
One hanging rope;
Two batteries(optional);
One User Manual.
6 Installation
6.1 View of the front panel
Figure 2 Front view
6.2 Battery
Step 1. Refer to Figure 3. and insert the two AAA size batteries properly in the right direction.
Step 2. Replace the cover.
Please take care when you insert the batteries for the improper insertion may damage the
device.
Figure 3 Batteries installation
7
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 4 Mounting the hanging rope
7 Operating Guide
1)
2)
Insert the two batteries properly to the direction, and then replace the cover.
Open the clip as shown in Figure 5.
Figure 5 Put finger in position
3) Let the patient’s finger put into the rubber cushions of the clip (make sure the finger is in the
right position), and then clip the finger.
4) Press the switch button once on front panel.
5) Do not shake the finger and keep the patient 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 three functions.When the device is power off, pressing the button can
open it; When the device is power on, pressing the button shortly can change direction of the screen;
When the device is power on, pressing the button long can change brightness of the screen.
Press the button shortly when the device is power on, the display mode will change, show as follow
figure:
8
Figure 6 Display mode one
Figure 7 Display mode two
Figure 8 Display mode three
Figure 9 Display mode four
Figure 10 Display mode five
9
Figure 11 Display mode six
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 best storage environment of the device is - 40ºC to 60ºC ambient temperature and not
higher than 95% relative humidity.
The device needs to be calibrated once a year (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.
10
9 Troubleshooting
Trouble
Possible Reason
Solution
The SpO2 and Pulse
Rate can not be
displayed normally
1. The finger is not properly
positioned.
2. The patient’s SpO2 is 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 SpO2 and Pulse
Rate are not
ed stabl
display
displayed
stablyy
1. The finger is not placed inside
1. Place the finger properly and try
deep enough.
again.
2. The finger is shaking or the patient
2. Let the patient keep calm
is moving.
The device can not
ed on
be turn
turned
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 device will power off
automatically when it gets no signal
within 5 seconds.
2. The batteries are almost drained.
1. Normal.
2. Change batteries.
10 Key of Symbols
Symbol
Description
Type BF
Warning – See User Manual
The pulse oxygen saturation(%)
PRbpm
Pulse rate (bpm)
The battery voltage indication is deficient (change the battery in time
avoiding the inexact measure)
1. no finger inserted
2. An indicator of signal inadequacy
battery positive electrode
battery cathode
1.Power switch
2.change direction of the screen
3.Change brightness of the screen
SN
Serial number
Alarm inhibit
11
WEEE (2002/96/EC)
IPX1
Ingress of liquids rank
This item is compliant with Medical Device Directive 93/42/EEC of
June 14, 1993, a directive of the European Economic Community.
11 Function Specification
Display Information
Display Mode
The Pulse Oxygen Saturation (SpO2)
OLED
Pulse Rate (PR)
OLED
Pulse Intensity (bar-graph)
OLED bar-graph display
Pulse wave
OLED
SpO2 Parameter Specification
Measuring range
0%~100%, (the resolution is 1%).
Accuracy
70%~100%:±2% ,Below 70% unspecified.
Optical Sensor
Red light (wavelength is 660nm)
Infrared (wavelength is 880nm)
Pulse Parameter Specification
Measuring range
30bpm~250bpm (the resolution is 1 bpm)
Accuracy
±2bpm 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 50g (with the batteries)
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Appendix
Guidance and manufacture
manufacture’’s declaration-electromagnetic emission
for all EQUIPMENT and SYSTEMS
Guidance and manufacture
manufacture’’s declaration –electromagnetic emission
The CMS50D Pulse Oximeter is tended for use in the electromagnetic environment specified below. The
customer of the user of the CMS50D Pulse Oximeter should assure that it isused in such an environment.
Emission test
compliance
Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1
The CMS50D 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
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emission
IEC 61000-3-3
Not applicable
The CMS50D Pulse Oximeter is suitable for use in all
establishments,including domestic establishments and
those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
Guidance and manufacture
manufacture’’s declaration-electromagnetic immunity
for all EQUIPMENT and SYSTEMS
Guidance and manufacture
manufacture’’s declaration-electromagnetic immunity
The CMS50D Pulse Oximeter is intended for use in the electromagnetic environment specified specified below.
The the user of CMS50D Pulse Oximeter should assure that it is used in such an environment.
Immunity test
IEC60601 test level
Compliance level
Electromagnetic
guidance
environment
environment-guidance
Electrostatic
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
13
Guidance and manufacture
manufacture’’s declaration-electromagnetic immunity
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture
manufacture’’s declaration-electromagnetic immunity
The CMS50D Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
customer or the user of CMS50D Pulse Oximeter should assure that it is used in such an environment.
Immunity
test
IEC60601
test level
Radiated RF
ICE
61000-4-3
3V/m
80MHz
2.5GHz
Compliance
level
3V/m
to
guidance
Electromagnetic environment -guidance
Portable and mobile RF communication equipment should be
used no closer to any part of the CMS50D Pulse Oximeter,
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
recommended separation distance
�3.5 �
d �� � P
�E1 �
80MHz to 800MHz
�7 �
d �� � P
�E1 �
800MHz to 2.5GHz
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 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 CMS50D Pulse
Oximeter is used exceeds the applicable RF compliance level above, the CMS50D 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 CMS50D Pulse Oximeter.
b
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3V/m.
14
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
D Pulse Oximeter
portable and mobile RF communications equipment and the CMS50
CMS50D
The CMS50D Pulse Oximeter is intended for use in the electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the CMS50D Pulse Oximeter
can help prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the CMS50D 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
�3.5 �
d �� � P
�E1 �
�3.5 �
d �� � P
�E1 �
�7 �
d �� � P
�E1 �
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.
15