PROFESSIONAL MEDICAL PRODUCTS
PULSOXIMETRO OXY-2
OXY-2 FINGER OXIMETER
OXYMÈTRE DE POULS OXY-2
PULSIOXÍMETRO OXY-2
OXÍMETRO DE PULSO OXY-2
ΠΑΛΜΙΚΌ ΌΞΎΜΕΤΡΌ OXY-2
Manuale d’uso - User manual
Manuel de l’utilisateur - Guía de uso
Guia para utilização - Οδηγίες χρήσης
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.
ATENCIÓN: Los operadores tienen que leer y entender completamente este manual
antes de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender completamente este manual antes
de usar o produto.
ΠΡΌΣΌΧΗ: Οι χειριστές αυτού του προϊόντος πρέπει να διαβάσουν και να
καταλάβουν πλήρως τις οδηγίες του εγχειριδίου πριν από την χρήση του.
CMS50DL (Gima 35072)
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
Importato da / Imported by / Importé par / Importado por /
Importado por / Εισάγεται από:
Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy
3
gima@gimaitaly.com - export@gimaitaly.com
.2
www.gimaitaly.com
08
.
3
Shanghai International Holding Corp. GmbH (Europe)
Eiestrasse 80, 20537, Hamburg, Germany
M35072-M-Rev.
-40°C
+60°C
95%
%
50kPa
0%
106kPa
0123
IP22
18ENGLISH
Instructions to User
Dear users, thank you very much for purchasing the
Pulse Oximeter.
The Manual describes, in accordance with the Pulse Oximeter’s features and requirements, main structure, functions, specications, correct methods for transportation,
installation, usage, operation, repair, maintenance and
storage, etc. as well as the safety procedures to protect
both the user and equipment. Refer to the respective
chapters for details.
Please read the User Manual carefully before using this
product. The User Manual which describes the operating procedures should be followed strictly. Failure to follow the User Manual may cause measuring abnormality,
equipment damage and human injury. The manufacturer
is NOT responsible for the safety, reliability and performance issues and any monitoring abnormality, human
injury and equipment damage due to users’ negligence
of the operation instructions.
The manufacturer’s warranty service does not cover
such faults.
Owing to the forthcoming renovation, the specic products you received may not be totally in accordance with
the description of this User Manual. We would sincerely
regret for that. This product is medical device, which can
be used repeatedly.
WARNING
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.
For the special patients, there should be a more pru-
dent 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
19 ENGLISH
device is harmful to the eyes, so the user and the
maintenance man should not stare at the light.
Testee can not use enamel or other makeup.
Testee’s ngernail can not be too long.
Please refer to the correlative literature about the clin-
ical 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. 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 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 qualied service engineers ONLY. Users are not permitted
to maintain it by themselves.
• The oximeter cannot be used together with devices
not specied 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 inammable 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.
ENGLISH
• 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.
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1.3 Attentions
Keep the oximeter away from dust, vibration, corro-
sive 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.
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
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110kg).
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.
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 electried 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.
ENGLISH
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.
ENGLISH
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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 ngers
into a ngertip 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 24 hours.
• The product will automatically be powered off when no
signal is in the product within 5 seconds.
• Low-battery indicator as battery icon ash manner.
2.2 Major Applications and Scope of Application
The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through nger, 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.
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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.
2.3 Environment Requirements
Storage Environment
a) Temperature: -40°C~+60°C
b) Relative humidity: ≤95%
c) Atmospheric pressure: 500hPa~1060hPa
Operating Environment
a) Temperature: 10°C~40°C
b) Relative Humidity: ≤75%
c) Atmospheric pressure: 700hPa~1060hPa
ENGLISH
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 photosensitive element, information acquired through which will be
shown on screen through treatment in electronic circuits
and microprocessor.
ENGLISH
Glow and Infrared-ray
Emission Tube
Glow and Infrared-ray
Receipt Tube
Figure 1. Operating Principle
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3.2 Caution
1. The nger should be placed properly (see the at-
tached 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 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 includes uorescent lamp, dual ruby light,
infrared heater, direct sunlight and etc.
6. Strenuous action of the subject or extreme electro-
surgical 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
pulse, substantial 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
25
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 hemoglobin, and some with icterus problem, the SpO2
determination by this monitor may be inaccurate.
3. The drugs like dopamine, procaine, prilocaine, li-
docaine 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.
ENGLISH
4 TECHNICAL SPECIFICATIONS
1. Display Format: Digital tube Display
SpO2 Measuring Range: 0% - 100%
Pulse Rate Measuring Range: 30 bpm - 250 bpm
Pulse Intensity Display: columniation display
2. Power Requirements: 2 ×1.5V AAA alkaline battery,
adaptable range: 2.6V~3.6V
3. Power Consumption: Smaller than 25 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 or ±2% (select larger) for Pulse Rate.
6. Measurement Performance in Weak Filling
Condition: SpO2 and pulse rate can be shown cor-
rectly when pulse-lling ratio is 0.4%. SpO2 error is
±4%, pulse rate error is ±2 bpm or ±2% (select larger).
7. Resistance to surrounding light: The deviation be-
tween the value measured in the condition of manmade 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 nger is in the device.
ENGLISH
9. Optical Sensor
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
Optical sensor is a light-emitting component,
which will affect other medical devices appling the same wavelength range.
5 ACCESSORIES
• One hanging rope
• Two batteries (optional)
• One User Manual
6 INSTALLATION
6.1 View of the Front Panel
Power switch
Pulse rate
The display SpO2
Low voltage display
Figure 2. Front View
Figure 3. Batteries Installation
Pulse rate
bargraph display
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ENGLISH
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.
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.
Figure 4. Mounting the hanging rope
Figure 5. Put nger in position
ENGLISH
7 OPERATING GUIDE
7.1 Insert the two batteries properly to the direction, and
then replace the cover.
7.2 Open the clip as shown in Figure 5.
7.3 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.
7.4 Press the switch button once on front panel.
7.5 Do not shake the nger and keep the patient at ease
during the process. Meanwhile, human body is not
recommended in movement status.
7.6 Get the information directly from screen display.
7.7 In boot-strap state,press button ,and the device is
reset.
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 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 -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.
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29
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.
ENGLISH
9 TROUBLESHOOTING
Trouble Possible Reason Solution
The SpO2 and
Pulse Rate can
not be displayed
normally.
The SpO2 and
Pulse Rate are not
displayed stably.
The device can
not be turned on.
The display is off
suddenly.
1. The nger is not
properly positioned.
2. The patient’s SpO2
is too low to be
detected.
1. The nger is not
placed inside deep
enough.
2.
The nger is shaking
or the patient is moving.
1. The batteries are
drained or almost
drained.
2. The batteries are not
inserted properly.
3. The malfunction of
the device.
1. The device will
power off automatically
when it gets no signal
within 5 seconds.
2. The batteries are
almost drained.
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.
1. Place the nger
properly and try
again.
2. Let the patient
keep calm.
1. Change
batteries.
2. Reinstall
batteries.
3. Please contact
the local service
center.
1. Normal.
2. Change
batteries.
ENGLISH
10 SYMBOLS
Symbol
% SpO
PRbpm Pulse rate (bpm)
Description
Type BF applied part
The pulse oxygen saturation(%)
2
The battery voltage indication is decient
(change the battery in time avoiding the inexact
measure)
1. No nger inserted
2. An indicator of signal inadequacy
Battery positive electrode
Battery cathode
Power switch
Serial number
Alarm inhibit
IP22
Covering Protection rate
Keep in a cool, dry place
Keep away from sunlight
Medical Device complies with Directive 93/42/
EEC
Product code
Lot number
Caution: read instructions (warnings) carefully
WEEE disposal
Follow instructions for use
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ENGLISH
Manufacturer
Authorized representative in the European
community
Date of manufacture
+60°C
-40°C
0%
50kPa
Store between -40 and 60°C
95%
%
Humidity limitation
106kPa
Atmospheric pressure limitation
11 FUNCTION SPECIFICATION
Display Information Display Mode
The Pulse Oxygen
Saturation (SpO2)
Pulse Rate (BPM) Digital
Pulse Intensity (bar-graph) Digital bar-graph display
SpO2 Parameter Specication
Measuring range 0%~100%, (the resolution is 1%).
Accuracy 70%~100%: ±2%
Optical Sensor Red light (wavelength is 660nm)
Pulse Parameter Specication
Measuring range 30bpm~250bpm (the resolution
Accuracy ±2bpm or ±2% select larger
Pulse Intensity
Range Continuous bar-graph display,
Digital
Below 70% unspecied
Infrared (wavelength is 880nm)
is 1 bpm)
the higher display indicate the
stronger pulse
ENGLISH
Battery Requirement
1.5V (AAA size) alkaline batteries × 2 or rechargeable battery
Battery Useful Life
Two batteries can work continually for 24 hours
Dimensions and Weight
Dimensions 60(L) × 30.5(W) × 32.5(H) mm
Weight About 50g (with the batteries)
Disposal: The product must not be disposed
of along with other domestic waste. The users
must dispose of this equipment by bringing it to a
specic recycling point for electric and electronic
equipment. For further information on recycling
points contact the local authorities, the local
recycling center or the shop where the product
was purchased. If the equipment is not disposed
of correctly, nes or penalties may be applied in
accordance with the national legislation and regulations.
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