Gima 35093 Use And Maintenance Book

Gima 35093 Use And Maintenance Book

Oxy-4 pulse oximeter
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PROFESSIONAL MEDICAL PRODUC TS
OXY-4 PULSE OXIMETER
PULSOXIMETRU
PULSOXIMETER
PULSSIOKSIMETRI
PULSNI OKSIMETAR
PULZOXIMÉTER
ПУЛСОВ ОКСИМЕТЪР
PULSOXYMETER
Use and maintenance book
Manual de utilizare și întreținere
Instruktioner för användning och underhåll
Käyttö- ja huolto-ohjeet
ATTENTION: The operators must carefully read and
completely understand the present manual before
using the product.
AVERTISMENT: Orice accident grav produs, privitor la
dispozitivul medical fabricat de firma noastră, trebuie
semnalat producătorului și autorității competente în sta-
tul membru pe teritoriul căruia își are sediul utilizatorul.
OBS: Det är nödvändigt att meddela tillverkaren och de
behöriga myndigheterna i den berörda medlemsstaten,
om alla allvarliga olyckor som inträffat i samband med
den medicintekniska utrustning som levererats av oss.
VAROITUS: Kaikista vakavista tapaturmista, jotka
liittyvät toimittamamme lääkinnällisen laitteen käyttöön,
on ilmoitettava valmistajalle sekä oman asuinpaikan
jäsenmaan toimivaltaiselle viranomaiselle
PAŽNJA: Potrebno je prijaviti svaku ozbiljnu nezgodu
koja se dogodila u vezi s isporučenim medicinskim proiz-
vođaču i nadležnom tijelu države članice u kojoj se nalazi.
35093
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Medicare AG, Hauptstr. 51
5024 Küttigen, Schweiz
CHRN-AR-20002506
Priručnik za uporabu i održavanje
Kezelési és karbantartási útmutató
Инструкции за употреба и поддръжка
Instructies voor gebruik en onderhoud
FIGYELEM: A gyártónak, illetve a székhely szerinti
tagállam illetékes hatóságának jelezni kell bármilyen
olyan súlyos balesetet, amely az általunk szállított
orvostechnikai eszközzel kapcsolatban történt
FIGYELMEZTETÉS: Всички сериозни инциденти,
които са настъпили във връзка с доставеното
от нас медицинско изделие, трябва да
се сигнализират на производителя и на
компетентния орган на държавата членка, в
която производителят е установен.
WAARSCHUWING: Alle ernstige ongelukken die zich
in verband met het door ons geleverde medische
hulpmiddel voordoen, moeten gemeld worden aan de
fabrikant en aan de bevoegde instantie van de lidstaat
waar u gevestigd bent
0476

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Summary of Contents for Gima 35093

  • Page 1 članice u kojoj se nalazi. 35093 Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy 0476 gima@gimaitaly.com - export@gimaitaly.com www.gimaitaly.com Medicare AG, Hauptstr. 51 5024 Küttigen, Schweiz CHRN-AR-20002506...
  • Page 2: Instructions For Safe Operations

    ENGLISH INSTRUCTIONS TO USER Read these instructions carefully before using this equipment. These in- structions 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 re- sponsible for the safety, relia- bility and performance issues and any mon- itoring abnormality, personal injury and equipment damage due to user’s negligence of the operation instructions.
  • Page 3 ENGLISH - Keep the oximeter away from dust, vibration, corrosive sub- stances, explosive materials, high temperature and moisture. – The device should be kept out of the reach of children. - If the oximeter gets wet, please stop using it and do not resume oper- ation until it is dry and checked for correct operation.
  • Page 4: Major Applications And Scope

    ENGLISH 2AAA alkaline batteries with low power consumption. - Low battery voltage indication. Lanyard Hole Display Battery Cover Lock button of battery cover Nameplate Display Key Rubber Cushion Figure 1 2.2 Major Applications and Scope The Fingertip Oximeter is compact, convenient to use and carry and with low power consumption.
  • Page 5 ENGLISH nal oxygen saturation – a percentage of all measured hemoglobin, including dysfunctional hemoglobin, such as carboxyhemoglobin or metahemo- globin. Clinical application of pulse oximeters: SpO2 is an important phys- iological parameter to reflect the respiration and ventilation function, so SpO2 moni- toring used in treatment has become more popular.
  • Page 6: Battery Installation

    ENGLISH B. The SpO2 sensor and photoelectric receiving tube should be ar- ranged in a way with the subject’s arteriole in a position there be- tween. C. The SpO2 sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injec- tion.
  • Page 7 ENGLISH 2. Put finger into the rubber cushions of the clip (make sure the finger is in the correct position), and then clip the finger. 3. The device will power on automatically in 2 seconds, and start to dis- play software version number.
  • Page 8: Technical Specifications

    ENGLISH Screen Description: “%SpO2”: The title of SpO2; “99”: SpO2 value, unit:%; “PR”: The title of Pulse Rate; “65”: Pulse Rate value, unit: bpm (beat per mi- nute); “ ”: Pulse beat icon; “ ”: Pulse bar-graph; “PI%”: The title of Perfusion Index; “1.4”: Perfusion Index value, unit: %; “...
  • Page 9: Repair And Maintenance

    ENGLISH C. Perfusion Index (PI) Display Range: 0.2%~20% D. Audible & visual over-limit indication When measuring, if SpO2 value or pulse rate value exceeds the limit, the device will beep automatically and the value which exceeds its limit will flash on the screen.
  • Page 10: Cleaning And Disinfecting Instruction

    ENGLISH ensure its long service life, please pay attention to the use of maintenance. A. Please change the batteries when the low-voltage indicator lightens. B. Please clean the surface of the device before using. Wipe the device with 75% alcohol wipes, and then let it dry in air or wipe it dry. Do not allow liquid to enter the device.
  • Page 11: Key Of Symbols

    Date of manufacture CONDIZIONI DI GARANZIA GIMA Si applica la garanzia B2B standard Gima di 12 mesi. Smaltimento: Il prodotto non deve essere smaltito assieme agli altri rifiuti domesti- ci. Gli utenti devono provvedere allo smaltimento delle apparecchiature da rotta- mare portandole al luogo di raccolta indicato per il riciclaggio delle apparecchiatu- re elettriche ed elettroniche.
  • Page 12: Information On Electromagnetic Compatibility

    ENGLISH INFORMATION ON ELECTROMAGNETIC COMPATIBILITY Electromagnetic compatibility Levels of compliance with the EN 60601-1-2:2015 standard - ESD immunity 15kV in air and 8kV on contact (EN 61000-4-2) - Burst immunity 2kV/100kHz (EN 61000-4-4) - Surge immunity (EN 61000-4-5): 1kV common/2kV differential - Magnetic field (EN 61000-4-8): 30A/m - Immunity to rf currents in the range 150kHz-80MHz (EN 61000-4-6) 3V modulation 80% 1kHz...
  • Page 13 ENGLISH radiated disturbances are under control. The customer or the operator can help prevent electromagnetic interference by ensuring a minimum distance between mobile and portable RF communication devices (transmitters) and the medical device, as recommended below, in relation to the maximum output power of the radio communication devices Rated maximum Distance (m) of separation according to the frequency...

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