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PULSOXIMETRO OXY-50
OXY-50 PULSE OXIMETER
OXYMÈTRE DE POULS OXY-50
PULSIOXÍMETRO OXY-50
M35100-M-Rev.5-01.22
PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in China
35100 0476
IP22
19 ENGLISH
Instructions to User
Dear users, thank you very much for purchasing the Pulse Oximeter (hereinafter referred to as device).
This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical
devices and harmonized standards. In case of modications and software upgrades, the information
contained in this document is subject to change without notice.
It is a medical device, which can be used repeatedly.
The Manual describes, in accordance with the device’s features and requirements, main structure, func-
tions, specications, correct methods for transportation, installation, usage, operation, repair, mainte-
nance and storage, etc. as well as the safety procedures to protect both the user and device. Refer to
the respective chapters for details.
Please read the User Manual carefully before using this device. The User Manual which describes the
operating procedures should be followed strictly. Failure to follow the User Manual may cause measur-
ing abnormality, device damage and human injury. The manufacturer is NOT responsible for the safety,
reliability and performance issues and any monitoring abnormality, human injury and device 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 specic products you received may not be totally in accord-
ance with the description of this User Manual. We would sincerely regret for that.
Our company has the nal interpretation to this manual. The content of this manual is subject to change
without prior notice.
Warnings
Remind that it may cause serious consequences to tester, user or environment.
Explosive hazard—DO NOT use the device in environment with inammable gas such as anesthetic.
DO NOT use the device while examining by MRI or CT, as the induced current may cause burn.
Do not take the information displayed on the device as the sole basis for clinical diagnosis. The de-
vice is only used as an auxiliary means in diagnosis. And it must be used in conjunction with doctor’s
advice, clinical manifestations and symptoms.
The maintenance to the device can only be performed by qualied service personnel specied by
manufacturer. Users are not permitted to maintain or ret the device by themselves.
Uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the micro-
circulation disturbance users. It is not recommended that the sensor is used on the same nger for
more than 2 hours.
For some special users who need a more careful inspection on the test site, please don’t place the
device on the edema or tender tissue.
Please do not stare at the red and infrared light emitter (the infrared light is invisible) after turning on
the device, including the maintenance staff, as it may be harmful to the eyes.
The device contains silicone, PVC, TPU, TPE and ABS materials, whose biocompatibility has been
tested in accordance with the requirements in ISO 10993-1, and it has passed the recommended
biocompatibility test. The person who is allergic to silicone, PVC, TPU, TPE or ABS can not use this
device.
The disposal of scrap device, its accessories and packaging should follow the local laws and regula-
tions, to avoid polluting to the local environment. And the packaging materials must be placed in the
region where the children are out of reaching.
The device can not be used with the equipment not specied in the Manual. Only the accessories
appointed or recommended by the manufacturer can be used, otherwise it may cause injury to the
tester and operator or damage to the device.
The SpO2 probe accompanied is only suitable for using with the device. The device can only use the
SpO2 probe described in the Manual, so the operator has the responsibility to check the compatibility
between the device and the SpO2 probe before using, incompatible accessories may cause device
performance degradation, device damage or patient injury.
Do not reprocess the accompanying SpO2 probe.
Check the device before use to make sure that there is no visible damage that may affect user’s safety
and device performance. When there is obvious damage, please replace the damaged parts before use.
When the message “Sensor Off” or “Sensor Fault” appears on the screen, it indicates that the SpO2
probe is disconnected or line fault occurs. Check the connection of the SpO2 probe and whether
there is damage for the probe, if necessary, please replace the probe to avoid risks. The probe fault
will not result in a safety hazard.
20
ENGLISH
Functional testers can not be used to assess the accuracy of the SpO2 probe and Pulse Oximeter.
Some functional testers or patient simulators can be used to verify whether the device works normal-
ly, for example, INDEX-2LFE Simulator (software version: 3.00), please refer to the Manual for the
detailed operation steps.
Some functional testers or patient simulators can measure the accuracy of the device copied calibra-
tion curve, but they can not be used to evaluate the device accuracy.
When using the device, please keep it away from the equipment which can generate strong electric
eld or strong magnetic eld. Using the device in an inappropriate environment may cause interfer-
ence to the surrounding radio equipment or affect its working.
The measured accuracy will be affected by the interference of electrosurgical equipment.
When several products are used on the same patient(people) simultaneously, danger may occur
which is arisen from the overlap of leakage current.
CO poisoning will appear excessive estimation, so it is not recommended to use the device.
This device is not intended for treatment.
The intended operator of the device may be a patient.
Avoid maintaining the device during using.
1 OVERVIEW
The oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2 concen-
tration in the blood, it is an important physiological parameter for the respiratory and circulatory system.
A number of diseases related to respiratory system may cause the decrease of SpO2 in the blood,
furthermore, some other causes such as the malfunction of human body’s self-adjustment, damages
during surgery, and the injuries caused by some medical checkup would also lead to the difculty of oxy-
gen supply in human body, and the corresponding symptoms would appear as a consequence, such as
vertigo, impotence, vomit etc. Serious symptoms might bring danger to human’s life. Therefore, prompt
information of patients’ SpO2 is of great help for the doctor to discover the potential danger, and is of
great importance in the clinical medical eld.
Insert the nger when measuring, the device will directly display the SpO2 value measured, it has a
higher accuracy and repeatability.
1.1 Features
A. Easy to use.
B. Small in volume, light in weight, convenient to carry.
C. Low power consumption.
1.2 Applied range
The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through
nger. The product is suitable for being used in family, hospital, oxygen bar, community healthcare,
physical care in sports (It can be used before or after doing sports, and it is not recommended to use the
device during the process of having sport) and etc.
1.3 Environment requirements
Ambiente di conservazione
Storage Environment
a) Temperature: -40℃ ~ + 60℃
b) Relative humidity: ≤ 95%
c) Atmospheric pressure: 500 hPa ~ 1060 hPa
Operating Environment
a) Temperature: +10℃~ + 40℃
b) Relative Humidity: ≤ 75%
c) Atmospheric pressure: 700 hPa ~ 1060 hPa
1.4 Precautions
1.4.1 Attention
Point out conditions or practices that may cause damage to the device or other properties
Before using the device, make sure that it locates in normal working state and operating environ-
Produktspecifikationer
| Varumärke: | Gima |
| Kategori: | Medicinsk |
| Modell: | OXY 50 |
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