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.

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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

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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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