A - 8
A.5.11.1 System Capacity
In a range of 10 m
2
, there should be no more than 3 groups of paired monitors and bluetooth
nodes working simultaneously.
A.5.11.2 Resistance to Interference
The distance between the interfering devices and the monitor is greater than 20 cm. The
interfering devices include 2.4 GHz Wi-Fi devices, bluetooth communication devices,
remote controls, microwave ovens, intercoms, cellular mobile networks, and cordless
phones.
The monitoring network must support the following requirements:
■
The total delay of data transmission from the monitor to the bluetooth node: ≤ 6
seconds.
■
The success rate for transmission of vital signs data from the monitor to the
bluetooth node: > 99%.
A.5.11.3 Line of Sight Distance
The line of sight distance between the monitor and the bluetooth node is no less than 10
meters.
A.6
Measurement Specifications
A.6.1
SpO
2
Specifications
A.6.1.1
Mindray SpO
2
Module Specifications
Alarm limit
Range (%)
Step (%)
SpO
2
High
(low limit + 2) to 100
1
SpO
2
Low
Mindray, Masimo: (Desat +1) to (high limit – 2)
Nellcor: (Desat+1) or 20 (whichever is greater) to (high limit – 2)
Desat
0 to (low limit – 1)
Standards
Meet standards of ISO 80601-2-61
*Measurement accuracy verification: The SpO
2
accuracy has been verified in human
experiments by comparing with arterial blood sample reference measured with a CO-
oximeter. Pulse oximeter measurements are statistically distributed and about two-thirds
of the measurements are expected to come within the specified accuracy range compared
to CO-oximeter measurements.
SpO
2
Measurement range
0 to 100%
PI measurement range
0.05% to 20%
SpO
2
Resolution
1%
Summary of Contents for VS 8A
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