Gima OXY-0 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.0.03.23
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 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.
ENGLISH

5
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
ENGLISH

6
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-
ENGLISH

7
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
ENGLISH

8
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
ENGLISH

9
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 .
ENGLISH

10
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
ENGLISH