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Pressure Accuracy
Pressure Increments: 4.0 to 20.0 cm H
Maximum static pressure accuracy, according to ISO 80601-2-70:2015:
Pressure
10 cm H
O
2
Static pressure accuracy has a measurement uncertainty of 3.7%
Maximum dynamic pressure variation, according to ISO 80601-2-70:2015:
Pressure
< 10 cm H
O
2
≥ 10.0 to 20 cm H
Dynamic pressure accuracy has a measurement uncertainty of 4.3%
Note: All tests were performed with and without humidifier and with both 22 mm standard tube and
15 mm heated tube.
Maximum Flow Rate (typical)
22 mm
tubing
15 mm
tubing
(heated
or non-
heated)
Disposal
Separate collection for electrical and electronic equipment per EC Directive 2012/19/EU. Dispose of this device in
accordance with local regulations.
EMC Information
Your unit has been designed to meet EMC standards throughout its Service Life without additional maintenance. There is always
an opportunity to relocate your DreamStation Therapy Device within an environment that contains other devices with their own
unknown EMC behavior. If you believe your unit is affected by locating it closer to another device, simply separate the devices to
remove the condition.
Pressure and Flow Accuracy
The DreamStation Therapy Device is designed to perform within the pressure and flowrate accuracies specified in the user manual.
If you suspect that the pressure and/or flow rate accuracy is affected by EMC interference remove power and relocate the device to
another area. If performance continues to be affected discontinue use and contact your home care provider.
SpO2 and Pulse Rate Accuracy
The DreamStation Therapy Device is designed to capture the SpO
described in the sensor manufacture's instructions for use. When 4 hours of successful oximetry data have been achieved the device
indicates this to the user by displaying "Oximetry: Good Study". If you suspect that your unit is affected by EMC interference remove
power and relocate the device to another area. If performance continues to be affected discontinue use and contact your home care
provider.
User Manual
Static Accuracy
± 0.5 cm H
10 BPM
± 0.3 cm H
O
± 0.4 cm H
2
Measured pressure at the patient
connection port (cm H
2
Average flow at the patient
connection port (l/min)
Measured pressure at the patient
connection port (cm H
2
Average flow at the patient
connection port (l/min)
O (in 0.5 cm H
O increments)
2
2
O
2
15 BPM
O
± 0.4 cm H
2
O
± 0.7 cm H
2
Test pressures (cm H
4.0
2.4
O)
137.0
151.0
2.9
O)
139.0
139.0
and Pulse Rate oximetry data within the accuracy specification
2
20 BPM
O
± 0.6 cm H
2
O
± 0.9 cm H
2
O)
2
8.0
12.0
16.0
6.8
10.8
14.7
150.0
160.0
6.8
10.8
14.7
139.0
146.0
O
2
O
2
20.0
18.6
170.0
18.7
151.0
27
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