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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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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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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