Gima OXY-0 CMS50Q1 Instruction Manual

PULSOXIMETRO PEDIATRICO OXY-0
OXY-0 PEDIATRIC OXIMETER
OXYMÈTRE PÉDIATRIQUE OXY-0
OXÍMETRO PEDIÁTRICO OXY-0
OXY-0 PEDIATRIC OXYMETER
OXY-0 PULSOXIMETRU PEDIATRIC
Importato da / Imported by / Importé par / Importado por /
Importat de / Importerad av:
Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
M35056-M-Rev.0.02.23
CMS50Q1 (GIMA 35056)
0123
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street,
Economic & Technical Development Zone, Qinhuangdao,
Hebei Province, PEOPLE’S REPUBLIC OF CHINA
Made in China
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537, Hamburg, Germany
IP22
+60°C
-40°C
%
95%
0%
1060hPa
500hPa
PROFESSIONAL MEDICAL PRODUCTS
ATTENZIONE: Gli operatori devono leggere e capire completamente questo manuale prima di
utilizzare il prodotto.
ATTENTION: The operators must carefully read and completely understand the present manual
before using the product.
AVIS: Les opérateurs doivent lire et bien comprendre ce manuel avant d’utiliser le produit.
ATENÇÃO: Os operadores devem ler e entender completamente este manual antes de usar o
produto.
FÖRSIKTIGHET: Operatörer måste läsa och helt förstå denna manual innan produkten används.
ATENȚIE: Operatorii trebuie să citească și să înțeleagă pe deplin acest manual înainte de a
utiliza produsul.

24ENGLISH
Pulse Oximeter
CMS50Q1
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 modi-
cations and software upgrades, the information contained
in this document is subject to change without notice.
The Manual describes, in accordance with the Pulse Oxi-
meter’s features and requirements, main structure, fun-
ctions, specications, 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, equip-
ment damage and personal injury. The manufacturer is
NOT responsible for the safety, reliability and performan-
ce issues and any monitoring abnormality, personal injury
and equipment damage due to user’s negligence of the
operation instructions. The manufacturer’s warranty ser-
vice does not cover such faults.
Owing to the forthcoming renovation, the specic pro-
ducts 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 repeate-
dly. Its using life is 3 years..
WARNING:

25 ENGLISH
0The uncomfortable or painful feeling may appear if
using the device ceaselessly, especially for the micro-
circulation barrier patients. It is recommended that the
sensor should not be applied to the same nger for
over 2 hours.
0For 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.
0The light (the infrared is invisible) emitted from the de-
vice is harmful to the eyes, so the user and the main-
tenance man, can not stare at the light.
0Testee can not use enamel or other makeup.
0Testee’s ngernail can not be too long.
0Please peruse the relative content about the clinical
restrictions and caution.
0This device is not intended for treatment.
Caution: Federal law restricts this device to sale by or on
the order of a physician.
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 af-
fect patient’s safety and monitoring performance about
cables and transducers. It is recommended that the de-
vice should be inspected once a week at least. When
there is obvious damage, stop using the monitor.
• Necessary maintenance must be performed by quali-
ed service engineers ONLY. Users are not permitted to
maintain it by themselves.
• The oximeter cannot be used together with devices
not specied 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 envi-
ronment with inammable gas such as some ignitable

26
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 regula-
tions.
• 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 possi-
bility of working abnormally.
• Please don’t measure this device with function test pa-
per for the device’s related information.
1.3 Attentions
Keep the oximeter away from dust, vibration, corrosi-
ve 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 ma-
terials.
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°C.
As to the ngers 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 nger such as
thumb and middle nger deeply enough into the probe.
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27
Do not use the device on infant or neonatal patients.
The product is suitable for children (Weight should be
between 10 kg to 40kg).
Prevent children from swallowing the product or its ac-
cessories.For children users, please use the product
under the condition of adult guardianship
The device may not work for all patients. 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 measu-
red 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 stan-
dard one.
If some abnormal conditions appear on the screen
during test process, pull out the nger and reinsert to
restore normal use.
The device has normal useful life for three years since
the rst electried 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 at-
tention 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 fun-
ction, 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 exible circuit connects the two parts of the device.
Do not twist or pull on the connection.
1.4 Indication for Use
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28
The Pulse Oximeter is a non-invasive device intended
for the spot-check of saturation of arterial hemoglobin(-
SpO2) and the pulse rate of children in home use en-
vironments.This device is not intended for continuous
monitoring.The device can be multi-used.Pulse oximeter
intended for wellness use.
2 Overview
The pulse oxygen saturation is the percentage of HbO2
in the total Hb in the blood, so-called the O2 concentra-
tion 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 ngers
into a ngertip photoelectric sensor for diagnosis, and a
display screen will directly show measured value of He-
moglobin Saturation.
2.1 Classification
Class II b, (MDD93/42/EEC IX Rule 10)
2.2 Features
• SpO2 value display, Pulse rate value display, bar graph
display, Pulse waveform display
• The display mode can be changed
• Screen brightness can be changed
• Power consumption of the product is low and the two
originally equipped AAA batteries can be operated con-
tinuously for 20 hours.
• The product will enter standby mode when no signal is
in the product within 5 seconds.
2.3 Major Applications and Scope
of Application
The Pulse Oximeter can be used to measure human He-
moglobin Saturation and pulse rate through nger, and
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29
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 continuo-
us 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°C ~ +60°C
b) Relative humidity: ≤95%
c) Atmospheric pressure: 500 hPa ~ 1060 hPa
Operating Environment
a) Temperature: 10°C ~ 40°C
b) Relative Humidity: ≤75%
c) Atmospheric pressure: 700 hPa ~ 1060 hPa
3 Principle and Caution
3.1 Principle of Measurement
Principle of the Oximeter is as follows: An experience for-
mula of data process is established taking use of Lambert
Beer Law according to Spectrum Absorption Characteri-
stics of Reductive Hemoglobin (Hb) and Oxyhemoglobin
(HbO2) in glow & near-infrared zones. Operation principle
of the instrument is: Photoelectric Oxyhemoglobin In-
spection Technology is adopted in accordance with Capa-
city Pulse Scanning & Recording Technology, so that two
beams of different wavelength of lights can be focused
onto human nail tip through perspective clamp nger-type
sensor. Then measured signal can be obtained by a pho-
tosensitive element, information acquired through which
will be shown on screen through treatment in electronic
circuits and microprocessor
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30
Glow and Infrared-ray
Emission Tube
Glow and Infrared-ray
Receipt Tube
Figure 1 Operating principle
3.2 Precautions
1. The nger should be placed properly (see the atta-
ched illustration of this manual, Figure 5), or else it
may cause inaccurate measurement.
2. The SpO2 sensor and photoelectric receiving tube
should be arranged in a way with the subject’s arterio-
le in a position there between.
3. The SpO2 sensor 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 ob-
stacles like rubberized fabric.
5. Excessive ambient light may affect the measuring re-
sult. It includes uorescent lamp, dual ruby light, infra-
red heater, direct sunlight and etc.
6. Strenuous action of the subject or extreme electrosur-
gical interference may also affect the accuracy.
7. Testee can not use enamel or other makeup.
3.3 Clinical Restrictions
1. As the measure is taken on the basis of arteriole pul-
se, substantial pulsating blood ow of subject is re-
quired. For a subject with weak pulse due to shock,
low ambient/body temperature, major bleeding, or
use of vascular contracting drug, the SpO2 waveform
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31
(PLETH) will decrease. In this case, the measurement
will be more sensitive to interference.
2. For those with a substantial amount of staining dilu-
tion drug (such as methylene blue, indigo green and
acid indigo blue), or carbon monoxide hemoglobin
(COHb), or methionine (Me+Hb) or thiosalicylic he-
moglobin, and some with icterus problem, the SpO2
determination by this monitor may be inaccurate.
3. The drugs like dopamine, procaine, prilocaine, lidocai-
ne and butacaine may also be a major factor blamed
for serious error of SpO2 measure.
4. 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: LCD Display; SpO2 Measuring
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 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
bpm ~ 99 bpm and ±2% during the pulse rate range of
100 bpm ~ 250 bpm .
6. Measurement Performance in Weak Filling Condition:
SpO2 and pulse rate can be shown correctly when
pulse-lling ratio is 0.4%. SpO2 error is ±4%, pulse
rate error is ± 2 bpm during the pulse rate range of 30
bpm ~ 99 bpm and ±2% during the pulse rate range of
100 bpm ~ 250 bpm .
7. Resistance to surrounding light: The deviation betwe-
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32
en the value measured in the condition 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 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)
5 Accessories
One hanging rope;
Two batteries(optional)
One User Manual.
6 Installation
6.1 View of the Front Panel
Figure 2 Front view
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33
Figure 3 Batteries installation
Figure 4 Mounting the hanging rope
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, turn the screw.
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 rst one and
then tighten it..
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 5.
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34
Figure 5 Put nger in position
3) Let the patient’s nger put into the rubber cushions of
the clip (make sure the nger is in the right position), and
then clip the nger.
4) Press the button once on front panel.
5) Do not shake the nger and keep the patient at ease
during the process. Meanwhile, human body is not re-
commended 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 di-
splayed on the screen.
• Please clean the surface of the device before using.
Wipe the device with medical alcohol rst, 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 -40 ºC
to 60 ºC ambient temperature and not higher than
95% relative humidity.
• Users are advised to calibrate the device termly (or ac-
cording 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
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35
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
Problem Possible cause Solution
The SpO2 and
Pulse Rate can
not be displayed
normally
1. The nger is not
properly positioned.
2. The patient’s
SpO2 is too low to
be detected.
1. Place the nger
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 displayed
stably
1. The nger is not
placed inside deep
enough.
2. The nger is
shaking or the
patient is moving.
1. Place the nger
properly and try
again.
2. Let the patient
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
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36
10 Key of Symbols
Type BF applied part
Follow instructions for use
The pulse oxygen saturation (%)
PR bpm Pulse rate (bpm)
The battery voltage indication is decient (change
the battery in time avoiding the inexact measure)
1. No nger inserted
2. An indicator of signal inadequacy
Battery positive electrode
Battery cathode
1. Change brightness of the screen.
2. Exit standby mode
Serial number
Alarm inhibit
WEEE disposal
IP22 Covering Protection rate
Medical Device complies with Directive 93/42/EEC
Manufacturer
Date of manufacture
Temperature limit
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37
%
Humidity limit
Atmospheric pressure limit
This side up
Fragile; maneggiare con cura
Keep away from sunlight
Keep away from sunlight
Product code
Lot number
Caution: read instructions (warnings) carefully
Authorized representative in the European community
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 Specication
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38
Measuring range 0% ~ 100%, (the resolution is 1%).
Accuracy 70% ~ 100%: ±2%, Below 70%
unspecied.
Optical Sensor Red light (wavelength is 660 nm)
Infrared (wavelength is 880 nm)
Pulse Parameter Specication
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
1.5 V (AAA size) alkaline batteries × 2 or rechargeable battery
Battery Useful Life
Two batteries can work continually for 20 hours
Dimensions 59(L) × 37(W) × 35(H) mm
Weight About 50g (with the batteries)
Appendix
Guidance and manufacture’s declaration-electromagnetic
emission
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration –electromagnetic
emission
The CMS50Q1 Pulse Oximeter is tended for use in the
electromagnetic environment specied below. The customer of
the user of the CMS50Q1 Pulse Oximeter should assure that it
isused in such an environment.
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39
Emission test Compliance Electromagnetic
environment-guidance
RF emissions
CISPR 11 Group 1
The CMS50Q1 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 CMS50Q1 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
uctuations/
icker
emission
IEC 61000-3-3
Not applicable
Guidance and manufacture’s declaration-electromagnetic
immunity for all EQUIPMENT and SYSTEMS
The CMS50Q1 Pulse Oximeter is intended for use in the
electromagnetic environment specied specied below.
The the user of CMS50Q1 Pulse Oximeter should assure that it
is used in such an
environment.
Immunity test IEC60601
test level Compliance level
Electromagnetic
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 oor are covered
with synthetic
material, the relative
humidity should be
at least 30%.
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40
Power
frequency
(50Hz)
magnetic eld
IEC
61000-4-8
3 A/m 3 A/m
Power frequency
magnetic elds
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 CMS50Q1 Pulse Oximeter is intended for use in the
electromagnetic environment specied below. The customer or the
user of CMS50Q1 Pulse Oximeter should assure that it is used in
such an environment.
Immunity
test IEC60601 test level Compliance level
Electromagnetic
environment
-guidance
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41
Radiated
RF ICE
61000-
4-3
3V/m
80MHz to
2.5GHz 3 V/m
Portable and mobile RF
communication equipment
should be used no
closer to any part of the
CMS50Q1 Pulse Oximeter,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
recommended separation
distance
80MHz to
800MHz
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
xed 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:
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42
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
reection from structures, objects and people.
a. Field strengths from xed 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 xed RF
transmitters, an electromagnetic site survey should be considered.
If the measured eld strength in the location in which The
CMS50Q1 Pulse Oximeter is used exceeds the applicable RF
compliance level above, the CMS50Q1 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 CMS50Q1 Pulse Oximeter.
b. Over the frequency range 150 KHz to 80 MHz, eld strengths
should be less than 3V/m.
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 CMS50Q1 Pulse
Oximeter
The CMS50Q1 Pulse Oximeter is intended for use in the
electromagnetic environment in which radiated RF disturbances
are controlled.The customer or the user of the CMS50Q1 Pulse
Oximeter can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the CMS50Q1
Pulse Oximeter as recommended below, according to the
maximum output power of the communications equipment.
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