Remind SetupSound ReminderBeepDemoRestoreBrightness

Limit SetupSpO2 HiSpO2 loPR HiPR Lo+/-

*onoffonOK4

*1009413050+

Exit Exit

Type 1 Type 2

Type 3 Type 4

Type 5 Type 6

98 75%SpO2 PR bpm

PI%5.5

98 98

98

98 75

75 75

75%SpO2

SpO

2%

SpO

2%

PR bpm

PR bpm

PR b

pm

PI%

PI%

PI%

5.5 PI%5.5

5.5 5.5

%SpO2PR bpm

98 75%SpO2 PR bpm

PI%5.5

a Field strengths from fixed transmitters such as basestations for radio(cellular/cordless)telephones and landmobile radios amateur radio. AM and FMradio broadcastand TV broadcast cannot be predicted theoretically withaccuracy To assess the electromagnetic environment dueto fixed RF transmitters an electromagnetic site surveyshould be considered. If the measured field strength in thelocation in which the pulse Oximeter is used exceeds theapplicable RF compliance level above, the Pulse Oximetershould be observed to verify normal operation. If abnormalperformance is observed, additional measures may benecessary, such as reorienting or relocating the PulseOxImeterb Over the frequency range 150 kHz to 80 MHz, fieldstrengths should be less than 3V/m.

NOTE l At 80 MHz and 800 MHz, the higher frequencyrange appliesNOTE 2 These guidelines may not apply in all situations.Electromagnetic is affected by absorption and reflectionfrom structures, objects and people.

Recommended separation distances betweenportable and mobileRF communications equipment and theEQUIPMENT or SYSTEM-for EQUIPMENTand SYSTEMS that are notLIFE-SUPPORTING

Recommended separation distances betweenportable and mobile RF communications equipmentand the pulse oximeter

The Pulse Oximeter is intended for use in anelectromagnetic environment in which radiated RFdisturbances are controlled. The customer or theuser of the Pulse Oximeter can help preventelectromagnetic interference by maintaining aminimum distance between portable and mobile RFcommunications equipment (transmitters) and thePulse Oximeter as recommended below,according to the maximum output power of thecommunications equipment

For transmitters rated at a maximum output power not listedabove the recommended separation distance d in metres(m)can be estimated using the equation applicable to thefrequency of the transmitter, where P is the maximumoutput power rating of the transmitter in watts (W)according to the transmitter manufacturerNOTE l At 80 MHz and 800 MHz, the separation distancefor the higher frequency range appliesNOTE 2 These guidelines may not apply in all situationsElectromagnetic propagation is affected by absorption andreflection from structures, objects and people

Portable and mobile RF communications equipment should be used nocloser to any part of the Pulse Oximeter, including cables, than therecommended separation distance calculated from the equation applicableto the frequency of the transmitterRecommended separation distance

80 MHz to 800 MHz

800 MHz to 2.5 GHzwhere p is the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer and d is the recommendedseparation distance in metres (m).bField strengths from fixed RF transmitters, as determined by anelectromagnetic site survey, a should be less than the compliance level ineach frequency range. bInterference may occur in the vicinity of equipment marked with thefollowing symbol:

The Pulse Oximeter is intended for use in the electromagnetic environment specified below. Thecustomer or the user of the Pulse Oximeter should assure that it is used in such an environment.

Guidance and manufacturer’s declaration - electromagnetic immunity

Guidance and manufacturer’s declaration - electromagnetic immunity-for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

NOTE UT is the a.c. mains voltage prior to application of the test level.

Electromagnetic environment - guidanceImmunity test

Conducted RF

Power frequency(50/60 Hz)magnetic fieldIEC 61000-4-8

Power frequency magnetic fields should be atlevels characteristic of a typical location in a typical commercial or hospital environment.

30A/m 30A/m

IEC 61000-4-6

IEC 60601 test level

Compliancelevel

IEC 61000-4-3

Radiated RF

3 Vrms

150 kHz to80 MHz

80 MHz to2.7 Ghz

6Vrms in ISMbanda between150 kHz to80 MHz

N/A

10V/m

Ratedmaximumoutput of transmitterW

Separation distance according tofrequency of transmitter / m

150 kHz to80 MHz

80 MHz to800 MHz

800 MHzto 2.7 GHz

0.010.1110100

0.120.381.23.812

/////

0.230.732.37.323

Shenzhen Aeon Technology Co., Ltd.RM6H02. Block 27-29 Tianxia C Industrial ParkMajalong No 133 of Yiyuan road, Nantou StreetNanshan District. Shenzhen China Shanghai International Holding Corp Gmbh (Europe)Eiffestrasse 80, 20537 Hamburg, Germany

Immunity test

Electrostaticdischarge (ESD)

IEC 61000-4-2

IEC 60601 Compliancelevel Electromagnetic environment guidance

Floors should be wood, concrete orceramic tile.If floors are covered withsynthetic material, therelative humidityshould be at least 30 %.

Mains power quality should be that of a typicalcommercial or hospital environment.

Mains power quality should be that of a typicalcommercial or hospital environment.

Mains power quality should be that of a typicalcommercial or hospital environment. If the userof the Pulse Oximeter requires continuedoperation during power mains interruptions, itis recommended that the Pulse Oximeterbe powered from an uninterruptible powersupply or a battery.

test level

Electrostatictransient / burst

Surge

Voltage dips, shortinterruptions andvoltage variationson power supplyinput lines

IEC 61000-4-4

IEC 61000-4-5

IEC 61000-4-11

± 8 kV contact

± 15 kV air

± 8 kV contact

± 15 kV air

± 2 kV for powersupply lines

± 1 kV for input/outputlines± 1 kV differentialmode

0% UT 0,5 cycleg)At ， ， ， ， ， ， and0% UT; 1 cycleand 70% UT;25/30 cycles at 0°0% UT; 250/300cyclee

± 2 kV commonmode

0° 45°135°270° 315°

180° 225°90°

N/A

N/A

N/A

Manufacturer’s Declaration of the EMCGuidance and manufacturer’s declaration - electromagnetic emission -for all EQUIPMENT AND SYSTEMS

Guidance and manufacturer’s declaration - electromagnetic emission

Guidance and manufacturer’s declaration - electromagnetic immunity- for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration - electromagnetic immunity

Emissions test

RF emissions

CISPR 11Group 1

Class BRF emissions

Harmonic emissionsIEC 61000-3-2Voltage fluctuations /flicker emissionsIEC 61000-3-3

CISPR 11

Electromagnetic environment- guidanceCompliance

The Pulse Oximeter is intended for use in the electromagnetic environment specified below.The customer or the user of the Pulse Oximeter should assure that it is used in such an environment.

The Pulse Oximeteruses RF energy only for its internal function.Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The Pulse Oximeter is suitable for use in all establishments,including domestic establishments and those directly connectedto the public low-voltage power supply network that suppliesbuildings used for domestic purposes.

The Pulse Oximeter is intended for use in the electromagnetic environment specified below. Thecustomer or the user of the Pulse Oximetershould assure that it is used in such an environment.

N/A

N/A

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