Gima CMS50Q1 User 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
M35057-M-Rev.0.03.23
CMS50Q1 (GIMA 35057)
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 com-
prendre 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.

2
ENGLISH
Pulse Oximeter
CMS50Q1
Instructions to User
Dear Users, thank you very much for purchasing
our product.
This Manual is written and compiled in accordan-
ce with the council directive MDD93/42/EEC for medical devices and
harmonized standards. The Manual is written for the current Pulse Oxi-
meter. 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 Oximeter’s fea-
tures and requirements, main structure, functions, specications, cor-
rect 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.The-
se 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 specic products you received
may not be totally in accordance with the description of this User Ma-
nual. We would sincerely regret for that.
This product is medical device, and can be used repeatedly. Its using
life is 3 years..

3ENGLISH
WARNING:
0The 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
nger for over 2 hours.
0For the individual patients, there should be a more prudent in-
specting 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 device is harmful
to the eyes, so the user and the maintenance 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 affect patient’s safety and
monitoring performance about cables and transducers. It is recom-
mended 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 qualied service en-
gineers 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 recommenda-
tory by manufacture can be used with this device.
• This product is calibrated before leaving factory

4
1.2 Warnings
• Explosive hazard - DO NOT use the oximeter in environment with
inammable 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 packin-
gs(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 de-
vice’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 environ-
ment, 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 oxime-
ter 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 clea-
ning, 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.
Do not use the device on infant or neonatal patients.
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The product is suitable for children (Weight should be between 10
kg to 40kg).
Prevent children from swallowing the product or its accessories.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 change-
able 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 me-
asured value is optimal value. And the waveform at the moment is
the standard one.
If some abnormal conditions appear on the screen during test pro-
cess, 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 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 exible 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
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of children in home use environments.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 concentration in the blood. It is an
important bio-parameter for the respiration. For the purpose of measu-
ring 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 pa-
tient to put one of his ngers into a ngertip 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
• 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 equip-
ped AAA batteries can be operated continuously 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 Hemoglobin Satu-
ration and pulse rate through nger, and indicate the pulse intensity by
the bar-display. The product is suitable for use in family, hospital (Ordi-
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nary 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°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 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
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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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 attached illustration
of this manual, Figure 5), or else it may cause inaccurate measu-
rement.
2. The SpO2 sensor and photoelectric receiving tube should be arran-
ged in a way with the subject’s arteriole 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 obstacles like
rubberized fabric.
5. Excessive ambient light may affect the measuring result. It inclu-
des uorescent lamp, dual ruby light, infrared heater, direct sunlight
and etc.
6. Strenuous action of the subject or extreme electrosurgical interfe-
rence 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 pulse, substantial
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pulsating blood ow 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.
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 thiosali-
cylic hemoglobin, and some with icterus problem, the SpO2 deter-
mination by this monitor may be inaccurate.
3. The drugs like dopamine, procaine, prilocaine, lidocaine and buta-
caine 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 Dis-
play: columniation display and the waveform display.
2. Power Requirements: 2×1.5 V AAA alkaline battery (or using the re-
chargeable 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 .
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7. Resistance to surrounding light: The deviation between 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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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..
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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.
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 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
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• 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 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 am-
bient 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 envi-
ronment. 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.
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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
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
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Serial number
Alarm inhibit
WEEE disposal
IP22 Covering Protection rate
Medical Device complies with Directive 93/42/EEC
Manufacturer
Date of manufacture
Temperature limit
%
Humidity limit
Atmospheric pressure limit
This side up
Fragile; maneggiare con cura
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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
SpO2 Parameter Specication
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
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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.
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.
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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%.
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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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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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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