Nonin Onyx II 9550 Instructions For Use Download Page 4

Table 2: Electromagnetic Immunity

Manufacturer’s Declaration

Refer to the following tables for specific information regarding this device’s compliance to IEC 60601-1-2.

Table 1: Electromagnetic Emissions

Emissions Test

Compliance

Electromagnetic Environment—Guidance

This device is intended for use in the electromagnetic environment specified below. 

The customer and/or user of this device should ensure that it is used in such an environment.

RF Emissions

 

CISPR 11

Group 1

This device uses 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.

RF Emissions

 

CISPR 11

Class B

This device is suitable for use in all establishments, including domestic and those directly 
connected to the public low-voltage power supply network that supplies buildings used for 
domestic purposes.

Harmonic Emissions

 

IEC 61000-3-3

N/A

Voltage Fluctuations/Flicker Emissions

 

IEC 61000-3-3

N/A

Immunity Test

IEC 60601 Test Level

Compliance 

Level

Electromagnetic 

Environment—Guidance

This device is intended for use in the electromagnetic environment specified below. 

The customer and/or user of this device should ensure that it is used in such an environment.

Electrostatic Discharge (ESD)
IEC 61000-4-2

±6 kV contact
±8 kV air

±6 kV contact
±8 kV air

Floors should be wood, concrete, or ceramic tile. If 
floors are covered with synthetic material, relative 
humidity should be at least 30%. 

Electrical Fast Transient/Burst
IEC 61000-4-4

±2 kV for power supply lines
±1 kV for input/output lines

N/A

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

Surge 
IEC 61000-4-5

±1 kV differential mode
±2 kV common mode

N/A

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

Voltage dips, short interruptions, 
and voltage variations on power 
supply input lines
IEC 61000-4-11

±5% U

T  

(>95% dip in U

T

) for 0.5 cycle

±40% U

T  

(60% dip in U

T

) for 5 cycles

±70% U

T  

(30% dip in U

T

) for 25 cycles

<5% U

T  

(>95% dip in U

T

) for 5 sec.

N/A

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

Power Frequency
(50/60 Hz) Magnetic Field
IEC 61000-4-8

3 A/m

3 A/m

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

NOTE

: U

T

 is the AC mains voltage before application of the test level.

Summary of Contents for Onyx II 9550

Page 1: ...ravascular dyes may affect the accuracy of the SpO2 measurement Do not autoclave or immerse this device in liquid or use caustic or abrasive cleaning agents A flexible circuit connects the two halves Do not twist or pull the flexible circuit or overextend the device s spring Do not hang the lanyard from the device s flexible circuit strain relief A functional tester cannot be used to assess the ac...

Page 2: ...p touches the built in stop guide 2 Make sure the finger is lying flat not on its side and is centered within the device For best results keep the Onyx II at the patient s heart or chest level 3 If the device does not turn on remove the finger and wait a few seconds before reinserting it When a finger is inserted the Onyx II performs a brief startup sequence Verify that all LEDs illuminate during ...

Page 3: ...o 95 non condensing Altitude Operating Up to 40 000 feet 12 192 meters Hyperbaric Pressure Up to 4 atmospheres Battery Life Continuous Approximately 2 500 spot checks based on 21 hours of operation using two AAA size alkaline batteries calculated at 30 seconds per spot check Battery Life Storage 4 years minimum Classifications per IEC 60601 1 CSA 601 1 UL 60601 1 Degree of Protection Type BF Appli...

Page 4: ... use in the electromagnetic environment specified below The customer and or user of this device should ensure that it is used in such an environment Electrostatic Discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material relative humidity should be at least 30 Electrical Fast Transient Burst ...

Page 5: ...is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones an...

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