Contec Medical Systems Co. 35072 User manual

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.
Importato da / Imported by / Importé par / Importado por /
Importado por / Εισάγεται από:
Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy
[email protected] - [email protected]
www.gimaitaly.com
M35072-M-Rev.
3
.
08
.2
3
0123
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
Shanghai International Holding Corp. GmbH (Europe)
Eiestrasse 80, 20537, Hamburg, Germany
IP22
+60°C
-40°C
%
95%
0%
106kPa
50kPa
PROFESSIONAL MEDICAL PRODUCTS

18ENGLISH
Instructions to User
Dear users, thank you very much for purchasing the
Pulse Oximeter.
The Manual describes, in accordance with the Pulse Ox-
imeter’s features and requirements, main structure, func-
tions, 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 User Manual carefully before using this
product. The User Manual which describes the operat-
ing procedures should be followed strictly. Failure to fol-
low the User Manual may cause measuring abnormality,
equipment damage and human injury. The manufacturer
is NOT responsible for the safety, reliability and perfor-
mance 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 specic prod-
ucts 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 microcir-
culation 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 moni-
tor.
• 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
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.

20
• The disposal of scrap instrument and its accessories
and packings(including battery, plastic bags, foams
and paper boxes) should follow the local laws and reg-
ulations.
• 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 pos-
sibility 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, corro-
sive substances, explosive materials, high tempera-
ture 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 pa-
tients’ SpO2and pulse rate, please clip the thick n-
ger 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
ENGLISH

21
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 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 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 environ-
ments (including clinical use in internist/surgery, anes-
thesia, intensive care ect.).
This device is not intended for continuous monitoring.
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22
2 OVERVIEW
The pulse oxygen saturation is the percentage of HbO2
in the total Hb in the blood, so-called the O2concen-
tration 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 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 conven-
ient 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 He-
moglobin Saturation and pulse rate through nger, and
indicate the pulse intensity by the bar-display.
The product is suitable for use in family, hospital (Ordi-
nary sickroom ), Oxygen Bar, social medical organiza-
tions and also the measure of saturation oxygen and
pulse rate.
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23
The product is not suitable for use in continu-
ous supervision for patients.
The problem of overrating would emerge
when the patient is suffering from toxicosis
which caused by carbon monoxide, the de-
vice 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
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 per-
spective clamp nger-type sensor.
Then measured signal can be obtained by a photosensi-
tive element, information acquired through which will be
shown on screen through treatment in electronic circuits
and microprocessor.
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24
Figure 1. Operating Principle
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 SpO2sensor and photoelectric receiving tube
should be arranged in a way with the subject’s arteri-
ole in a position there between.
3. The SpO2sensor should not be used at a location
or limb tied with arterial canal or blood pressure cuff
or receiving intravenous injection.
4. Make sure the optical path is free from any optical
obstacles like rubberized fabric.
5. Excessive ambient light may affect the measuring
result. It includes 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 SpO2waveform
(PLETH) will decrease. In this case, the measurement
Glow and Infrared-ray
Emission Tube
Glow and Infrared-ray
Receipt Tube
ENGLISH

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 he-
moglobin, 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 SpO2measure.
4. As the SpO2value serves as a reference value for
judgement of anemic anoxia and toxic anoxia, some
patients with serious anemia may also report good
SpO2measurement.
4 TECHNICAL SPECIFICATIONS
1.Display Format: Digital tube Display
SpO2Measuring 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 SpO2and 1 bpm for Pulse Rate
5.Measurement Accuracy: ±2% in stage of 70%-100%
SpO2, and meaningless when stage being smaller than
70%. ±2 bpm or ±2% (select larger) for Pulse Rate.
6.Measurement Performance in Weak Filling
Condition: SpO2and pulse rate can be shown cor-
rectly when pulse-lling ratio is 0.4%. SpO2error 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 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 nger is in the device.
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26
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 ap-
pling the same wavelength range.
5 ACCESSORIES
• One hanging rope
• Two batteries (optional)
• One User Manual
6 INSTALLATION
6.1 View of the Front Panel
Figure 2. Front View
Figure 3. Batteries Installation
The display SpO2
Low voltage display
Power switch
Pulse rate
Pulse rate
bargraph display
ENGLISH

27
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 batter-
ies 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
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28
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 posi-
tion), 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 dis-
played 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 ac-
cording 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 de-
vice, or even damage it.
9 TROUBLESHOOTING
Trouble Possible Reason Solution
The SpO2and
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 SpO2and
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 device will power off automatically
when it gets no signal
within 5 seconds.
2. The batteries are
almost drained.
1. Normal.
2. Change
batteries.
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30
10 SYMBOLS
ENGLISH
Symbol Description
Type BF applied part
% SpO2The pulse oxygen saturation(%)
PRbpm 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
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

31
11 FUNCTION SPECIFICATION
Display Information Display Mode
The Pulse Oxygen
Saturation (SpO2)
Digital
Pulse Rate (BPM) Digital
Pulse Intensity (bar-graph) Digital bar-graph display
SpO2Parameter Specication
Measuring range 0%~100%, (the resolution is 1%).
Accuracy 70%~100%: ±2%
Below 70% unspecied
Optical Sensor Red light (wavelength is 660nm)
Infrared (wavelength is 880nm)
Pulse Parameter Specication
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
ENGLISH
Manufacturer
Authorized representative in the European
community
Date of manufacture
+60°C
-40°C Store between -40 and 60°C
%
95%
0%
Humidity limitation
106kPa
50kPa
Atmospheric pressure limitation

32
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
specic 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 reg-
ulations.
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)