Gima OXY-2 User Manual

PROFESSIONAL MEDICAL PRODUCTS

Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]

www.gimaitaly.com

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.

35072 / CMS50DL

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

M35072-M-Rev.2.11.20

-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, 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 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 specic 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 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 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.

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.

20

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

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.

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.