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Sleep Lab Help

Technical specifications

Intended delivered volume range (for ASV modes)

200-2500 mL

Maximum single fault steady state pressure

Device will shut down in the presence of a single fault if the steady state pressure exceeds:

40 cm H2O (40 hPa) for more than 1 second.

Pressure measurement tolerance

± 0.5 cm H2O (0.5 hPa) ±4% of measured reading

Flow measurement tolerance

± 6 L/min or 10% of reading, whichever is greater, at 0 to 150 L/min positive flow

Operating pressure range

CPAP

4-20 cm H2O (4-20 hPa) (measured at the mask)

CPAP with EPR

4-20 cm H2O (4-20 hPa) CPAP, With EPR settings: EPR off, Level 1 = 1.0 cm H2O (1 hPa), Level 2 = 2.0 cm H2O (2 hPa), Level 3 = 3.0 cm H2O (3 hPa) EPR reduces the pressure during expiration by the amount dependent on the level set above, but the pressure delivered will not drop below 4.0 cm H2O (4 hPa).

AutoSet, AutoSet for Her

4-20 cm H2O (4-20 hPa)

AutoSet with EPR, AutoSet for Her with EPR

4-20 cm H2O (4-20 hPa) APAP, With EPR settings: EPR off, Level 1 = 1.0 cm H2O (1 hPa), Level 2 = 2.0 cm H2O (2 hPa), Level 3 = 3.0 cm H2O (3 hPa) EPR reduces the pressure during expiration by the amount dependent on the level set above, but the pressure delivered will not drop below 4.0 cm H2O (4 hPa).

S, T, ST

IPAP: 4-25 cm H2O (4-25 hPa), EPAP: 3-25 cm H2O (3-25 hPa), Maximum pressure: 25 cm H2O (25 hPa)

VAuto

IPAP: 4-25 cm H2O (4-25 hPa), EPAP: 4-25 cm H2O (4-25 hPa), Pressure support: 0-10 cm H2O (0-10 hPa), Maximum pressure: 25 cm H2O (25 hPa)

ASV and ASVAuto

EPAP: 4-15 cm H2O (4-15 hPa), Min PS: 0-6 cm H2O (0-6 hPa), Max PS: 5-20 cm H2O (5-20 hPa), Maximum pressure = 25 cm H2O (25 hPa)

Flow (maximum) at set pressures

The following are measured according to ISO 80601-2-70:2015 and ISO 80601-2-70:2020

With HumidAir 11 humidifier tub

Pressure

cm H2O (hPa)

AirCurve 11 VPAP Tx and Standard air tubing

L/min

AirCurve 11 VPAP Tx and SlimLine

L/min

AirCurve 11 VPAP Tx and ClimateLineAir 11

L/min

4

161

170

161

8

165

174

169

12

167

177

175

16

169

172

170

20

167

165

165

25

164

156

156

With Side cover

Pressure

cm H2O (hPa)

AirCurve 11 VPAP Tx and Standard air tubing

L/min

AirCurve 11 VPAP Tx and SlimLine

L/min

AirCurve 11 VPAP Tx and ClimateLineAir 11

L/min

4

208

194

193

8

200

189

188

12

192

182

181

16

184

176

176

20

176

170

167

25

166

159

158

Note

Refer to the relevant measurement uncertainty from the Measurement system uncertainties table.

Sound

Declared dual-number noise emission values in accordance with ISO 4871:1996

Device with standard air tubing and side cover as measured according to ISO 80601-2-70:2020 and ISO 80601-2-79:2018

Sound pressure level

26 dBA with uncertainty of 2 dBA

Sound power level

34 dBA with uncertainty of 2 dBA

Device with standard air tubing and HumidAir 11 humidifier tub (HumidAir 11 humidifier tub half-filled) as measured according to ISO 80601-2-70:2020, ISO 80601-2-74:2021 and ISO 80601-2-79:2018

Sound pressure level

27 dBA with uncertainty of 2 dBA

Sound power level

35 dBA with uncertainty of 2 dBA

Physical Dimensions

Dimensions (H x W x D) with HumidAir 11 humidifier tub:

3.72" x 10.21" x 5.45" (94.5 mm x 259.4 mm x 138.5 mm)

Dimensions (H x W x D) with side cover:

3.72" x 9.32" x 5.45" (94.5 mm x 236.8 mm x 138.5 mm)

Air outlet:

The 22 mm conical outlet connector complies with EN ISO 5356-1:2015

Weight - device and HumidAir 11 humidifier tub:

43 oz (1229 g)

Weight - device with side cover:

44 oz (1236 g)

Housing construction:

Flame retardant engineering thermoplastic

Hot plate - Material:

Stainless steel

Water capacity:

380 mL

Time between each refill of the humidifier tub:

> 8 hours ±0.5 hours (tested at 23 ±2°C / 73.4 ± 3.6 °F)

Recommended water type to use in the humidifier tub (Standard tub):

Distilled water

Recommended water type to use in the humidifier tub (Cleanable tub):

Drinking quality water (potable)

Humidifier tub - Material:

Injection molded plastic, stainless steel and silicone seal

90W power supply unit

Input range

100-240 V, 50-60 Hz, 1.0-1.5 A 115 V, 400Hz, 1.5 A for aircraft use

DC output:

24 V SL Symbol Direct current 3.75 A

Typical power consumption:

65.3 W (72.5 VA)

Peak power consumption:

103.4 W (109.9 VA)

Class of equipment

Class ll

Environmental conditions

Operating temperature

+41°F to +95°F (+5°C to +35°C)

Note

The airflow for breathing produced by this therapy device can be higher than the room temperature. Under extreme ambient temperature conditions (104°F/40°C) the device remains safe.

Operating humidity

10 to 95% relative humidity, non-condensing

Operating altitude

Sea level to 8,500' (2,591 m); air pressure range 1013 hPa to 738 hPa

Note

Using the device at high altitude in combination with high pressure and high flow may affect the delivered pressure and the accuracy of the displayed and reported values.

Storage pressure/Storage altitude

1013 to 738 hPa

Storage and transport temperature

-13°F to +158°F (-25°C to +70°C)

Storage and transport humidity

5 to 95% relative humidity, non-condensing

Air Filter

Standard:

Material: Polyester non woven fiber Average arrestance: >75%, when tested to EN779.

Hypoallergenic:

Material: Blended synthetic fibers in a polypropylene carrier Efficiency: >80% (average) when tested to EN13274-7.

Note

The use of a ResMed approved hypoallergenic filter will result in a small reduction in the accuracy of the delivered pressure at high leaks.

Electromagnetic compatibility

The AirCurve 11 VPAP Tx complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC 60601-1-2:2020, for residential, commercial and light industry environments.

Portable and mobile RF communications equipment should be used no closer to any part of the machine, including cables, than the recommended 3.94" (10 cm) separation distance.

The AirCurve 11 VPAP Tx has been designed to meet EMC standards. However, should you suspect that the device performance (eg. pressure or flow) is affected by other equipment, move the device away from the possible cause of interference.

Information regarding the electromagnetic emissions and immunity of this ResMed device can be found in ResMed.com/downloads/devices.

IEC 60601-1 classification

Class II (double insulation), Type BF, Ingress protection IP22.

Supplemental oxygen maximum flow

15 L/min

Aircraft use

ResMed confirms that the machine meets the Federal Aviation Administration (FAA) requirements (RTCA/DO-160, section 21, category M; RTCA-DO-160, section 20, category T) for all phases of air travel.

Design life

Device, power supply unit:

5 years

Cleanable humidifier tub:

2.5 years

Standard humidifier tub, Air tubing:

6 months

General

A clinician or sleep technician is an intended operator.

Pneumatic flow path

SL Diagram Pneumatic flow path (User)
  1. Flow sensor

  2. Blower

  3. Pressure sensor

  4. Mask

  5. Air tubing

  6. Humidifier

  7. Device

  8. Inlet filter

Displayed values

Value

Range

Display resolution

Pressure at mask[a]:

Mask pressure

Minimum EPAP to maximum pressure (See section above Operating pressure range)

0.1 cm H2O (0.1 hPa)

Flow derived values[a]:

Leak

0-120 L/min

0.1 L/min

Tidal volume

0-4000 mL

1 mL

Respiratory rate

0-90 BPM

1 BPM

Minute ventilation

0-30 L/min

0.1 L/min

Ti

0-10 sec

0.1 sec

I:E ratio

1:10-4:1

0,1

[a] Results are expressed as STPD (Standard Temperature and Pressure, Dry). Use the following table to convert the STPD flow setting to BTPS (Body Temperature and Pressure, Saturated) flow.

Value

Accuracy

Pressure at mask[a]:

Mask pressure

±0.5 cm H2O (0.5 hPa) + 4% of set value

Flow and flow derived values[a]:

Flow

±6 L/min or 10% of reading, whichever is greater, at 0 to 150 L/min positive flow

Leak

±6 L/min, at 0 to 60 L/min[a]

Tidal volume

±30 mL or 20% of reading, whichever is greater[a]

Respiratory rate

±1.0 BPM[a]

Minute ventilation

±20%[a]

[a] Accuracy may be reduced by the presence of leaks, supplemental oxygen, tidal volumes <100 mL or minute ventilation <3 L/min.

STPD to BTPS conversion

Altitude (m)

Ambient pressure (hPa)

STPD to BTPS conversion factor

0

1013.25

1.12

500

956.53

1.19

1000

902.41

1.27

1500

850.80

1.36

2000

801.60

1.45

2500

754.73

1.54

Pressure accuracy as tested according to ISO 80601-2-79:2018

± (0.5 cm H2O (hPa) + 4% of the set pressure) cm H2O (hPa)

Pressure accuracy - CPAP mode

Maximum static pressure variation at 10 cm H2O (10 hPa) according to ISO 80601-2-70:2015 and ISO 80601-2-70:2020

Device with HumidAir 11 humidifier tub / side cover and air tubing: ±0.5 cm H2O (±0.5 hPa)

Maximum dynamic pressure variation according to ISO 80601-2-70:2015

Device with HumidAir 11 humidifier tub / side cover and air tubing:

Breath rate

10 BPM

15 BPM

20 BPM

Dynamic pressure variation (cm H2O [hPa])

0.5

0.5

0.8

Maximum dynamic pressure variation according to ISO 80601-2-70:2020

Device with HumidAir 11 humidifier tub / side cover and air tubing:

Maximum error from set pressure (cm H2O [hPa]): ±1

Note

Refer to the relevant measurement uncertainty from the Measurement system uncertainties table.

Pressure accuracy - Bilevel modes

Maximum dynamic pressure variation according to ISO 80601-2-70:2015 and ISO 80601-2-70:2020

Device with HumidAir 11 humidifier tub / side cover and air tubing:

Inspiration/Expiration mean error ± standard deviation (cm H2O [hPa]): 1±0.1

Note

Refer to the relevant measurement uncertainty from the Measurement system uncertainties table.

% of Inspiratory Phase for calculation: > 60 % of Expiratory Phase for calculation: > 66

Note

For each inspiratory and expiratory breath phase, the data time slot starts immediately after the initial transient overshoot/undershoot period and ends at the point when flow diminishes to an absolute value equivalent to its starting point, towards the end of the breath phase.

Measurement system uncertainties

In accordance with ISO 80601‑2‑70:2020 and ISO 80601‑2‑79:2018 the measurement uncertainty of the manufacturer's test equipment is:

For measures of flow:

± 3.9 L/min

For measures of volume:

± 6 mL or 5% (whichever is greater)

For measures of static/dynamic pressure:

± 0.15 cm H2O (± 0.15 hPa)

For measures of time:

± 6 ms

In accordance with ISO 80601‑2‑70:2020 and ISO 80601‑2‑79:2018 the measurement uncertainty of the manufacturer's test equipment is:

For measures of humidification output:

± 0.5 mg/L BTPS

Bluetooth

Technology used:

Bluetooth Low Energy (BLE)

Connection types:

GATT

Frequency:

2400 to 2483.5 MHz

Max RF power output:

+4 dBm

Operation range:

10 m (Class 2)

Cellular technology and regulatory compliance

Refer to the Cellular information guide in ResMed.com/downloads/devices.

The device should be installed and operated with minimum distance 15 mm (0.59") between the equipment and the user's body.

Humidifier

Maximum heater plate temperature:

154ºF (68ºC)

Temperature cut-out (heater):

165ºF (74ºC)

Maximum gas temperature (at mask)[a]:

≤ 106ºF (41ºC)

[a] The air flow for breathing produced by this therapy device can be higher than the temperature of the room. Under extreme ambient temperature conditions (104ºF/40ºC) the device remains safe.

Humidifier performance

SlimLine/Standard tubing

Mask Pressure cm H2O (hPa)

Nominal RH output % at 72ºF (22ºC) ambient temperature

Nominal system output mg/L AH[a], BTPS[b]

Setting 4 (default setting)

Setting 8 (maximum setting)

Setting 4 (default setting)

Setting 8[c] (maximum setting)

3

80%

100%

≥6

≥12

4

80%

100%

≥6

≥12

10

80%

100%

≥6

≥12

20

80%

100%

≥6

≥12

25

80%

100%

≥6

≥12

[a] AH - Absolute Humidity in mg/L

[b] BTPS - Body Temperature Pressure Saturated

[c] Humidifier performance meets ISO 80601-2-74:2021 performance > 10 mg/L BTPS tested at 59°F to 95°F (15°C to 35°C)

Climate Control Auto - ClimateLineAir 11

Mask Pressure cm H2O (hPa)

Nominal RH output % at 72ºF (22ºC) ambient temperature

Nominal system output mg/L AH[a], BTPS[b]

3

85%

≥ 12

4

85%

≥ 12

10

85%

≥ 12

20

85%

≥ 12

25

85%

≥ 12

Air tubing

ClimateLineAir 11

SlimLine / Standard 2m / Standard 3m

ClimateLineAir 11 temperature range

60 to 86ºF (16 to 30ºC)

-

ClimateLineAir 11 temperature cut out

≤106ºF (≤41ºC)

-

Maximum recommended pressure

30 cm H2O (30 hPa)

30 cm H2O (30 hPa)

Maximum working temperature, when used with a humidifier

-

≤106ºF (≤41ºC)

Material

Flexible plastic and electrical components

Flexible plastic

Inner diameter

0.6" (15 mm)

SlimLine: 0.6" (15 mm) Standard 2m: 0.74" (19 mm) Standard 3m: 0.74" (19 mm)

Length

6'6" (2.0 m)

SlimLine: 6' (1.8 m) Standard 2m: 6'6" (2.0 m) Standard 3m: 9'10" (3.0m)

Note

The manufacturer reserves the right to change these specifications without notice.

Air tubing resistance to flow and compliance information

Refer to the Air tubing compliance guide in ResMed.com.