Infant Flow SiPAP Comprehensive Quick Guide Rev C

Table of contents Section 1: Circuit setup... 1 Open bed and isolette... 2 Abdominal sensor... 3 Pressure Nomogram for Infant Flow LP generator... 4 Alarm test... 5–6 Two point oxygen calibration... 7–8 Disabling oxygen sensor... 9 Startup menu and leak test... 10–11 Section 2: Operation... 12 Infant Flow SiPAP front panel... 12

Soft key operation... 13–14 Operational modes... 15–16 Alarm Set/Confirm screen... 17 Mode Select screen... 18 Parameter Adjust screen... 19 Incompatible settings... 20 Main screen... 21 Monitored Parameter screen... 22 Alarm management... 23 Final check and routine inspection... 24 Troubleshooting... 25

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Section 1: Circuit setup WARNING: • Do not attach generator to patient until verification and

Infant Flow SiPAP NCPAP/ Pres Low L/min

initial setup are complete.

Pres High L/min

14

50

12 10 8

60

5

70

40

80

21

100

90

30

4 3

6 4

2

2 1

CAUTION:

XDCR

• Follow manufacturer’s instructions for setup and operation of humidifier. OPTIONAL: • Use transducer interface for Apnea and Low Breath Rate alarm, and BiPhasic Tr mode (Intl only).

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PPROX

Open bed or crib

Isolette

Use extension tube with isolette. Remove extension tube if excessive condensation occurs.

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Abdominal sensor 1. Connect transducer to driver. 2. Connect respiratory sensor to transducer. 3. Compress the sensor gently; LED on the transducer illuminates. 4. Apply the sensor to the infant: a. Pressure line perpendicular to tape. b. Place between the umbilicus and xiphisternum. c. Alternative placement-the side of the abdomen. 5. Verify correct placement. Transducer LED illuminates on expiration, and front panel LED on inspiration. OPTIONAL: • Use transducer interface for Apnea detection and BiPhasic Tr mode.

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Pressure Nomogram for Infant Flow System The Infant Flow SiPAP system is subject to a direct relationship between the controlled gas flow and airway pressure. For example, 8 to 9 LPM gas flow provides approximately 5 cmH2O. 15.0 13.0 11.0 9.0 (cmH2O)

7.0 5.0 3.0 1.0 4.0

6.0

8.0

10.0

(LPM)

12.0

14.0

16.0

18.0

Flow pressure nomogram for SiPAP when used with the Infant Flow LP or AirLife ® variable-flow generator.

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Alarm test WARNING:

Alarm test initial settings

Prior to patient application, ensure that all User Verification testing and calibration procedures are

Air supply

> 30 psig (2.1 bar)

O2 supply

> 30 psig (2.1 bar)

successfully completed. User Verification testing and calibration procedures must be done off the patient.

Infant Flow LP generator/circuit nCPAP/press low

9 LPM

1. Connect air and O2 gas supply. Connect power cord to AC outlet. Attach patient circuit, generator and patient interface. Occlude the opening to the patient.

%O2

30%

Press high flow

3 LPM

Mode

nCPAP

Use settings below for step 9

2. Power up the driver and allow Power On Check to complete. 3. From nCPAP mode, with alarms set, remove occlusion from opening to the patient. Low pressure alarm activates. Restore the occlusion and reset the alarms.

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Rate

30 bpm

Ti

0.3 sec

Apnea/LBR interval

20 sec

Alarm test (continued) 4. Adjust the nCPAP/pres low flow meter to 11 LPM. The high airway pressure alarm activates. Decrease flow to 8 LPM. Reset the alarms. 5. Adjust the %O2 control to 35%. The High %O2 alarm activates. Return the O2 setting to 30%. Reset alarms. 6. Adjust the %O2 to 25%. The Low %O2 alarm activates. Return the O2 setting to 30%. Reset the alarms. 7. Disconnect the AC power cord from the wall outlet. The Loss AC alarm activates. Reconnect the AC power cord. Reset alarms. 8. Occlude exhalation line and increase nCPAP pressure to 11 cmH2O. The High Circuit pressure alarm activates. Decrease flow to 8 LPM and reset alarms. 9. Select and confirm BiPhasic mode. Change the mandatory rate control setting to 1. Low Breath rate alarm activates after the default interval of 20 seconds. Return to a rate of 30. Reset the alarms.

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Two point oxygen calibration 1. Adjust flow meters and turn on driver. 2. Press the Tool button in the Setup screen. 3. Adjust the Oxygen Control to 21%: a. Press the flashing button to confirm. b. Allow reading to stabilize. c. A check mark appears, and %O2 display should read 21%. 4. Adjust the Oxygen Control to 100%: a. Press the flashing button to confirm. b. Allow reading to stabilize. c. A check mark appears, and %O2 display should read 100%. 5. Press Exit button.

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Two point oxygen calibration (continued) NOTE: • If calibration fails, a red “X” is displayed, the alarm sounds and an Error code is displayed; repeat the calibration procedure. • Two point calibrations are required with initial setup and circuit changes.

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Disable oxygen sensor Disable O2 button 1. From Setup screen, press the calibration (CAL) button. 2. Press the O2 Disable button: a. Oxygen monitoring and the audible oxygen alarms are disabled. b. Error Code 55 is displayed. 3. Use an external oxygen analyzer to monitor FiO2. WARNING • Always use an external oxygen monitor if the oxygen sensor is disabled.

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Startup menu and leak test 1. Connect prong or mask to generator; occlude opening to patient. 2. Set nCPAP flow to 9 LPM and press high flow to 3 LPM. 3. Switch on the driver. 4. Verify measured pressure is 5 ±1% if less than 5 cmH2O is displayed. 5. Touch flashing icon to confirm. 6. Adjust O2% dial to desired setting. Verify measured value is within 3%. 7. Touch flashing icon to confirm. 8. Adjust high flow as desired and verify setting.

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Startup menu and leak test (continued) 9. Touch flashing icon to confirm. 10. Connect transducer assembly to the traducer interface connector on the front of the Infant Flow SiPAP, if desired. Touch flashing icon to confirm. A red “X” indicates the transducer assembly is not connected. 11. Touch nCPAP or Alarm Mute/Reset button to set alarms. 12. Measured CPAP should be 5 cmH2O. If not, check for leaks. 13. Remove occlusion to prongs or mask. Measured CPAP should drop to 0 to 2 cmH2O. If not, check for occlusions.

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Section 2: Operation Infant Flow SiPAP front panel

A

C

B

A. Power LED XDCR

B. Alarm warning bar D

C. Transducer interface LED D. LCD touch screen E. %O2 control

Infant Flow® SiPAP

F. Press High flow meter

NCPAP/ L/min

H. Transducer interface connection I. Circuit connection inspiratory limb

Press High

Press Low

G. Connection proximal pressure line

L/min

40 30

J

21

50 60 70 80 90

E

100

F

J. nCPAP/Press Low flow meter I H

G XDCR

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PPROX

Soft key operation Description

Example

A button that is enabled.

A button that is inhibited due to non-availability of the designated feature or pending acknowledgement of an active alarm condition. A selected mode or control pending confirmation that is visually highlighted and intermittently flashes between yellow and white text. While a button is pressed, the edges are highlighted to provide a pressed appearance.

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Soft key operation (continued) Description

Example

When there is an active alarm associated with a measured value, the measured value concerned is displayed with RED FLASHING text. The associated limit value (if any) is displayed in RED. When an alarm associated with a measured value is resolved, the device remains in a LOW priority alarm state, with the measured value displayed in YELLOW FLASHING text and the associated limit displayed in YELLOW, until the alarms are cleared by the operator. Manual Breath delivers a single BiPhasic cycle at current settings for T-High, Press High and %O2. Only one BiPhasic cycle is delivered regardless of button press duration.

If no screen interactions occur for a period of 120 seconds and there are no active alarms, the screen goes to a “locked” state to prevent inadvertent entries. To lock the screen, press the screen lock button.

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Operational modes CPAP is a constant single level of positive pressure to the infant’s airway, facilitating the restoration of functional residual capacity and correction of hypoxemia.

BiPhasic is two levels of pressures, delivered based on set Time High (T-High) criteria, rate and pressure settings. Small incremental pressure increases of 2 to 3 cmH2O augment functional residual capacity and can off-load work of breathing.

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Operational modes (continued) BiPhasic tr enables patient-triggered pressure assists via a respiratory abdominal sensor, with breath rate monitoring, adjustable Apnea time interval, Apnea alarm and adjustable Apnea backup rate. This enables respiratory support without the need of an endotracheal tube (ET tube).

Apnea detection is via a respiratory abdominal sensor. The Apnea alarm will be triggered when the set time interval is exceeded. If the infant breath is detected within the next time out period, the alarm will silence.

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Alarm set/confirm screen 1. Touch the nCPAP or Alarm button for 3 seconds to set the alarm limits. If neither button is touched within 2 minutes, the alarm limits will automatically set.

2. The Mode Select screen will display with the driver operating in nCPAP mode.

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Mode Select screen 1. Press the desired mode button. The display will change to the Parameter Adjust screen. NOTE: • Only the available modes will be displayed on the menu bar. • For Apnea and Biphasic trigger (tr)* modes, attach the transducer assembly and respiratory abdominal sensor.

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