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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.
EMC
Note:
• The device is subject to special EMC precautions and it must be installed and used in accordance
with these guidelines.
• The electromagnetic field 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 specified, 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 configuration 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:
N.
Name
1
USB cable
2
SpO2 probe
APPENDIX 1
State
Low voltage prompt
SpO2 prompt
Pulse rate prompt
Probe error prompt
ENGLISH
Cable length(m)
1,0
1,5
Prompt condition delay
1 s
330 ms
330 ms
16 ms
Shielding or not
Yes
No
Prompt signal generation delay
20 ms
20 ms
20 ms
20 ms
32
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