Gima PULSOXIMETRO OXY 9 Manual
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Gima PULSOXIMETRO OXY 9 Manual

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PROFESSIONAL MEDICAL PRODUC TS
PULSOXIMETRO OXY 9 - wireless
OXY 9 OXIMETER - wireless
OXYMÈTRE OXY 9 - sans fil
OXY 9 OXÍMETRO - inalámbrico
OXY 9 OXYMETER - kabellos
OXY 9 OXÍMETRO - sem fio
Gima 35078
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street,
Economic & Technical Development Zone,
Qinhuangdao, Hebei Province,
PEOPLE'S REPUBLIC OF CHINA
E-mail: med@eulinx.eu
Made in China
CMS50D-BT
Prolinx GmbH Brehmstr. 56,40239,
Duesseldorf, Germany
Importato da / Imported by / Importé par /
Importado por / Importado por / Eingeführt von:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
IP22
60°C
-40°C
500 hPa
0123
1060 hPa
95%
0%

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Summary of Contents for Gima PULSOXIMETRO OXY 9

  • Page 1 PROFESSIONAL MEDICAL PRODUC TS PULSOXIMETRO OXY 9 - wireless OXY 9 OXIMETER - wireless OXYMÈTRE OXY 9 - sans fil OXY 9 OXÍMETRO - inalámbrico OXY 9 OXYMETER - kabellos OXY 9 OXÍMETRO - sem fio Gima 35078 CONTEC MEDICAL SYSTEMS CO., LTD 0123 No.112 Qinhuang West Street,...

  • Page 2: User Notice

    ENGLISH CMS2.782.404(BT)(CE)ESS/1.1 1.4.01.51.208 2024.05 USER NOTICE Dear users, thank you very much for purchasing the Pulse Oxi- meter(hereinafter referred to as device). This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and harmo- nized standards.
  • Page 3 ENGLISH the sole basis for clinical diagnosis. The device is only used as an auxiliary means in diagnosis. And it must be used in conjunction with doctor’s advice, clinical manifestations and symptoms. 0 The maintenance to the device can only be performed by qualified service personnel specified by manufacturer, Users are not permitted to maintain or refit the device by themselves.
  • Page 4 ENGLISH it may cause injury to the tester and operator or damage to the device. 0 Check the device before use to make sure that there is no visible damage that may affect user’s safety and device per- formance. When there is obvious damage, please replace the damaged parts before use.

  • Page 5: Intended Purpose

    ENGLISH in the blood, so-called the O2 concentration 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, furthermo- re, some other causes such as the malfunction of human body’s self-adjustment, damages during surgery, and the injuries cau- sed by some medical checkup would also lead to the difficulty of...
  • Page 6 ENGLISH 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 environment. In order to get a more accurate measurement, it should be used in a quiet and comfortable environment.
  • Page 7 ENGLISH During measuring, when abnormal conditions appear on the screen, please pull out your finger and reinsert it to measure again. If some unknown error appears during measuring, remove the battery to terminate operating. Do not contort or drag the wire of the device. The plethysmographic waveform is not normalized, as a signal inadequacy indicator, when it is not smooth and stable, the accuracy of the measured value may degrade.
  • Page 8 ENGLISH light, make sure to place the sensor properly and cover the sensor with opaque material.  Frequent movement (active or passive) of the subject or severe activity can affect the measured accuracy.  The Pulse Oximeter should not be placed on a limb with the blood pressure cuff, arterial ductus or intraluminal tube.
  • Page 9 ENGLISH f. For detecting worsening lung function in patients on a high concentration of oxygen. 1.5 CLINICAL INDICATIONS The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through finger. 2 PRINCIPLE Glow and infrared ray emission tube Glow and infrared ray receipt tube...

  • Page 10: View Of The Front Panel

    ENGLISH I. Display mode can be changed 4 INSTALLATION 4.1 VIEW OF THE FRONT PANEL Figure 2. Front view Button: exit standby; 4.2 BATTERY INSTALLATION A. Refer to Figure 3 open the battery compartment cover on the back of the device,and insert the two AAA size batteries properly in the right direction.

  • Page 11: Application Method

    ENGLISH re, optional) . Attention: Please check the device and accessories according to the list to avoid that the device can not work normally. C. Software description Release version: V2 5 OPERATING GUIDE 5.1 APPLICATION METHOD A. Measurement and Data storage a) Insert the two batteries properly to the direction, and then replace the cover.

  • Page 12: Data Upload

    ENGLISH Time...” interface. The third method: Perform sync time, connect to power, then the device will turn on automatically, when it enters to “Synchronous Time...” inter- face, connect it with App, then it will automatically adjust time. Attention: Fingernails and the luminescent tube should be on the same side.

  • Page 13: Maintain, Transportation And Storage

    ENGLISH result in venous pulsation and inaccurate measure of SpO and pulse rate. F. Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby light, infrared heater, direct sunlight and etc. G. Strenuous action of the subject or extreme electrosurgical may also affect the accuracy.

  • Page 14: Troubleshooting

    ENGLISH B. The packed device should be stored in room with no corrosi- ve gases and good ventilation. Temperature: -40 °C ~ +60 °C; Relative humidity: ≤ 95% 7 TROUBLESHOOTING Trouble Possible Reason Solution 1) The finger is not properly inserted.

  • Page 15: Specification

    ENGLISH WEEE disposal Battery cathode Synchronous time Battery anode interface Covering Protection rate Humidity limitation IP22 Temperature limitation This side up Atmospheric pressure Keep away from rain limitation Fragile, handle with Bluetooth icon care Power button Manufacture Date Recyclable Finger Out The finger is not inserted. The finger clip falls off Use-by date (no finger inserted)
  • Page 16 ENGLISH Display range 30 bpm ~ 250 bpm Measured range 30 bpm ~ 250 bpm ±2 bpm during the pulse rate range of 30 bpm ~ 99 Accuracy[see bpm and ±2% during the pulse rate range of 100 bpm note 3] ~ 250 bpm.
  • Page 17 ENGLISH 18~50;skin color: dark black: 3, medium dark: 1, light: 7, white: 1) data in the clinical report. Note 2: because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of pulse oxime- ter equipment measurements can be expected to fall within ±Arms of the value measured by a CO-OXIMETER.
  • Page 18 ENGLISH they are operating normally. 0 Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 0 Portable RF communications equipment (including periphe- rals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the...
  • Page 19 ENGLISH Radiated RF EMISSIONS Class B Harmonic distortion IEC 61000-3-2 Not applicable Voltage fluctuations and flicker Not applicable IEC 61000-3-3 TABLE 2: Guidance and Declaration - Electromagnetic Immunity Immunity test IEC60601 test level Compliance level Electrostatic discharge ±8kV contact ±8kV contact (ESD) ±15 kV air ±15kV air...
  • Page 20 Disposal: The product must not be disposed of along with other domes- tic waste. The users must dispose of this equipment by bringing it to a specific recycling point for electric and electronic equipment. GIMA WARRANTY TERMS The Gima 12-month standard B2B warranty applies.

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