Bedienungsanleitung Gima OXY 50 (Seite 15 von 18) (Englisch)

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EMC

Note:

• The device is subject to special EMC precautions and it must be installed and used in accordance

with these guidelines.

• The electromagnetic eld can affect the device performance, so other equipment used near the de-

vice must meet the corresponding EMC requirements. Mobile phones, X-rays or MRI devices are

possible interference source, as they can emit high-intensity electromagnetic radiation.

• Refer to above chapters for the minimum value of user’s physiological signal. Inaccurate result will

appear when the device operates with the values lower than the descriptions in above chapter

• The use of ACCESSORIES, transducers and cables other than those specied, with the exception

of transducers and cables sold by the MANUFACTURER of the ME EQUIPMENT or ME SYSTEM

as replacement parts for internal components, may result in increased EMISSIONS or decreased

IMMUNITY of the ME EQUIPMENT or ME SYSTEM.

• The device should not be used adjacent to or stacked with other equipment and that if adjacent or

stacked use is necessary, it should be observed to verify normal operation in the conguration in

which it will be used.

• Devices or systems may still be interfered by other equipment, even if other equipment meets the

requirements of the corresponding national standard.

• Basic performance: SpO2 measured range: 70% ~ 100%, absolute error: ±2%; PR measured range:

30 bpm ~ 250 bpm, accuracy: ±2 bpm or ±2%, whichever is greater.

The following cable types must be used to ensure that they comply with interference radiation and im-

munity standards:

APPENDIX 1

ENGLISH

N. Name Cable length(m) Shielding or not Remark

1 USB cable 1,0 Yes

2SpO2 probe 1,5 No

State Prompt condition delay Prompt signal generation delay

Low voltage prompt 1 s 20 ms

SpO2 prompt 330 ms 20 ms

Pulse rate prompt 330 ms 20 ms

Probe error prompt 16 ms 20 ms

Note 2: because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of pulse oximeter equipment

measurements can be expected to fall within ±Arms of the value measured by a CO-OXIMETER.

Note 3: percentage modulation of infrared signal as the indication of pulsating signal strength, patient simulator has been used to verify

its accuracy under conditions of low perfusion. SpO2 and PR values are different due to low signal conditions, compare them with the

known SpO2 and PR values of input signal.

Note 4: optical sensors as the light-emitting components, will affect other medical devices applied the wavelength range. The information

may be useful for the clinicians who carry out the optical treatment.For example, photodynamic therapy operated by clinician.

Note 5: Patient simulator has been used to verify the pulse rate accuracy, it is stated as the root-mean-square difference between the

PR measurement value and the value set by simulator.

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Gima OXY 50 Seite 15

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