CareFusion Avea Auto-FiO2 Option Operators Manual Appendix Rev F

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This document is protected by United States and International Copyright laws. This document may not be copied, reproduced, translated, stored in a retrieval system, transmitted in any form, or reduced to any electronic medium or machine-readable form, in whole or in part, without the written permission of CareFusion. Information in this document is subject to change without notice. This document is for informational purposes only and should not be considered as replacing or supplementing the terms and conditions of the License Agreement. © 2010–2011 CareFusion Corporation or one of its subsidiaries. All rights reserved. Avea is a registered trademark of CareFusion Corporation or one of its subsidiaries. All other trademarks are the property of their respective owners. US CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887-4668 USA 800.231.2466 toll-free 714.283.2228 tel 714.283.8493 fax

EU Representative CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg Germany +49 931 4972-0 tel +49 931 4972-423 fax

carefusion.com

Literature number: L2814–101 Revision F

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Notices EMC Notice This equipment generates, uses, and can radiate radio frequency (RF) energy. If this equipment is not installed and used in accordance with the instructions in this manual, electromagnetic interference may result. This equipment has been tested and found to comply with the limits of acceptance set forth in Standard EN 60601-1-2 for Medical Products. These limits provide reasonable protection against electromagnetic interference (EMC) when operated in the intended use environments described in this manual. This ventilator is also designed and manufactured to comply with the safety requirements of Standard EN 60601-1, EN/ISO 9919, IEC 60601-2-12, CAN/CSA-C22.2 No. 601.1-M90, and UL 2601-1. This ventilator can be affected by portable and mobile RF communications equipment. This ventilator should not be stacked with other equipment. The following cables were used in the evaluation of this ventilator. • 15619 – Normally Open Patient Call Cable (Length – 1.7 meters) • 15620 – Normally Closed Patient Call Cable (Length – 1.7 meters) • 70600 – Cable, Communications (Length – 1 meter) • 70693 – Cable, Communications (Length – 3 meters) • Standard Centronix™ Printer Cable (Length – 2 meters) • Standard SVGA Monitor Cable (Length – 2 meters) Use of other cables may result in increased emissions or decreased immunity. See Tables 201, 202, 203, and 205 (below) for further information regarding the Avea Ventilator and EMC.

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Table 201. 60601-1-2 IEC:2001 (E) Guidance and manufacturer’s declaration – electromagnetic emissions The Avea Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the Avea Ventilator should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

Group 1

The Avea Ventilator uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class B

The Avea Ventilator is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply that supplies buildings used for domestic purposes.

CISPR 11 RF emissions CISPR 11 Harmonic emissions

Class A

IEC 61000-3-3 Voltage Fluctuation/

Complies

Flicker emissions IEC 61000-3-3

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Table 202. 60601-1-2 IEC:2001 (E) Guidance and manufacturer’s declaration - electromagnetic immunity The Avea Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the Avea Ventilator should assure that it is used in such an environment. Immunity Test

IEC 60601

Compliance level

Electromagnetic environment - guidance

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Test level Electrostatic discharge (ESD)

± 6 kV contact

± 6 kV contact

IEC 61000-4-2

± 8 kV air

± 8 kV air

Electrical fast transient/burst

± 6 kV for power supply lines

± 6 kV for power supply lines

IEC 61000-4-4

± 1 kV for input/output lines

± 1 kV for input/output lines

Surge

± 1 kV differential mode

± 1 kV differential mode

IEC 61000-4-5

± 2 kV common mode

± 2 kV common mode

Voltage dips, short interruptions and voltage variations on power supply input lines

<5 % UT

<5 % UT

(>95% dip in UT)

(>95% dip in UT)

IEC 61000-4-11

40 % UT

40 % UT

(60 % dip in UT)

(60 % dip in UT)

for 0,5 cycle

for 5 cycles

70 % UT

70 % UT

for 25 cycle

for 25 cycle

<5 % UT

(>95% dip in UT)

<5 % UT (>95% dip in UT)

3 A/m

3 A/m

for 5 seconds Power frequency (50/60 Hz) magnetic field

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

for 0,5 cycle

for 5 cycles

(30 % dip in UT)

Mains power quality should be that of a typical commercial or hospital environment.

Compliance is dependent on the operator following recommended charging and maintenance of the installed battery backup.

(30 % dip in UT)

for 5 seconds

Power frequency magnetic fields should be at level characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-8 Note: UT is the AC. mains voltage prior to application of the test level.

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Table 203. 60601-1-2 IEC:2001 (E) Guidance and manufacturer’s declaration – electromagnetic immunity The Avea Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the Avea Ventilator should assure that it is used in such an environment. Immunity Test

IEC 60601 Test level

Compliance level

Electromagnetic environment – guidance

Conducted RF IEC 61000-4-6

3 V rms 150 kHz to 80 MHz outside ISM bandsa

3V

10 V rms 150 kHz to 80 MHz In ISM bandsa

10 V

Portable and mobile RF communications equipment should be used no closer to any part of the Avea Ventilator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

10 V/m 80 MHz to 2,5 GHz

10 V/m

Radiated RF IEC 61000-4-3

Recommended separation distance:

80 MHz to 800 MHz 800 MHz to 2.5 GHz Where is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and is the recommended separation distance in meters (m). b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, c should be less than the compliance level in each frequency range. d Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a. The ISM (industrial, scientific, and medicinal) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27, 283 MHz; and 40,66 MHz to 40,70 MHz. b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges. c. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed FR transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Avea Ventilator is used exceeds the applicable RF compliance level above, the Avea Ventilator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Avea Ventilator. d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 205 60601-1-2 IEC:2001 (E) Recommended separation distance between portable and mobile RF communications equipment and the Avea Ventilator The Avea Ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Avea Ventilator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Avea Ventilator as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W)

Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz outside ISM bands

150 kHz to 80 MHz in ISM bands

80 MHz to 800 MHz

80 MHz to 800 MHz

0.01

0.12

0.12

0.12

0.23

0.1

0.37

0.38

0.38

0.73

1

1.16

1.20

1.20

2.30

10

3.67

3.79

3.79

7.27

100

11.60

12.00

12.00

23.00

For transmitters rated at a maximum output power not listed above, the recommended separation distance in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer. Note1. At 80 MHz and 800 MHz, the separation distance of the higher frequency range applies. Note 2. The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. Note 3. An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. Note4. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Regulatory Notice Federal law restricts the sale of this device except by or on order of a physician.

Manufacturer CareFusion 22745 Savi Ranch Parkway Yorba Linda, California 92887-4668 USA If you have a question regarding the Declaration of Conformity for this product, please contact CareFusion.

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Safety Information Please review the following safety information before operating the ventilator. Attempting to operate the ventilator without fully understanding its features and functions may result in unsafe operating conditions. Warnings and Cautions, which are general to the use of the ventilator under all circumstances, are included in this section. Some Warnings and Cautions are also inserted within the manual where they are most meaningful. Notes are also located throughout the manual to provide additional information related to specific features. If you have a question regarding the installation, set up, operation, or maintenance of the ventilator, contact CareFusion Customer Care.

Definition of Terms The following list describes the use of Note, Caution, and Warning statements in this document. Warnings identify conditions or practices that can cause a serious, adverse reaction or are potential safety hazards. Cautions identify conditions or practices that can cause damage to the ventilator or other equipment. Notes provide supplemental information to help you understand how the ventilator works.

Warnings The Warnings and Cautions listed here apply generally anytime you operate the ventilator. The warnings contained in this addendum are in addition to the warnings in the full Avea Operator’s Manual. When automatic control of FiO2 is being used, the patient should be monitored by appropriate cardiorespiratory monitors and trained, clinical personnel. The automatic control algorithm uses the Baseline FiO2 value to determine the Auto FiO2 Command value. Before initiating (or reinitiating) Automatic FiO2 Control, ensure that the FiO2 setting reflects the patient’s current clinical condition to ensure the control algorithm responds appropriately. Failure to do so will affect the response time of the control algorithm.

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Cautions The following cautions apply anytime you work with the ventilator: • Do not use damaged sensors or cables. • Do not immerse sensors or the oximeter module housing in any liquid. • Do not attempt to sterilize sensors by irradiation, steam, or ethylene oxide. • Do not apply excessive tension to any sensor cable. • Do not open the oximeter module housing. There are no user serviceable parts inside.

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Contents Notices ... iv EMC Notice ... iv Regulatory Notice ... iv Manufacturer ... ix Safety Information ...x Definition of Terms ...x Warnings ...x Cautions... xi Background ... 1 Theory of Operation ... 1 Initiating Automatic Control of Oxygen ... 2 Controls ... 3 Monitors ... 6 Alarms ... 8 Failsafe Operation ... 10 Discontinuing Automatic Control of Oxygen... 10

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Background Mechanically-ventilated, preterm infants often require supplemental oxygen. Typically, clinical goals include targeting specific oxygen saturation (SpO2) based on the infants underlying pathology. Clinicians routinely respond to high and low pulse oximeter alarms by adjusting oxygen (FiO2). Delay in responding to these alarms or inappropriate adjustments predispose the infant to poor tissue oxygenation or oxygen toxicity (as evidenced by chronic-lung disease and/or retinopathy of prematurity). The Automatic FiO2 control system uses the patient’s measured SpO2 to control the delivered FiO2 to the patient. When the system is enabled, it acts to maintain the patient’s SpO2 level between the SpO2 Target-Low Limit and SpO2 Target-High Limit by continuously titrating delivered FiO2 based on the measured SpO2. The system responds to both transient changes in SpO2, hypoxemia and hyperoxemia episodes, as well as long-term changes in the patient’s baseline FiO2 requirements.

Theory of Operation The Automatic FiO2 control system comprises three basic systems: • Pulse Oximetry • Control Algorithm • Gas Delivery Data is read continuously from the pulse oximeter module mounted on the Avea, and the SpO2 and heart rate are displayed on the UIM. The control algorithm receives updated SpO2 measurement data and calculates the appropriate FiO2 once per second. This value is then transmitted to the gas blender. The control algorithm is a feedback loop component of the entire system. The algorithm compares the patient’s SpO2 to that of the set value (the midpoint between the high and low SpO2 Targets). The algorithm uses this difference (or “error”) to set the FiO2. The algorithm makes immediate FiO2 changes to address the error, “learns” from past changes, and anticipates short term changes. These three tasks make up what is called a proportional-integral-derivative controller (PID controller).

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There are four factors that the algorithm responds to in order to determine what FiO2 should be delivered: • The difference between the target and actual SpO2 • The rate at which the SpO2 is changing • The range the patient is in (hyperoxemic, normoxemic or hypoxemic) as defined by the set high and low SpO2 targets • How long the actual SpO2 is “out of range” During periods of hypoxemia (SpO2 is lower than the Low SpO2 Target value), there is a rapid increase in FiO2 within 10 seconds of detection of hypoxemia. There will be a continuing rise in FiO2 while hypoxemia persists. The rate of FiO2 increase is proportionate to the magnitude of hypoxemia. Changes in FiO2 are proportionate to FiO2 baseline (a running average of the FiO2 under steady conditions). In periods of normoxia (SpO2 is between the low and high SpO2 target values), if the SpO2 is stable and remains above the set value, but in the targeted range, there is a gradual weaning of FiO2 downward. If the SpO2 is below the set value, but remains in the targeted range, no further decreases will occur. During hyperoxemic states (SpO2 is greater than the High SpO2 Target value), the controller decreases FiO2. Depending on the extent of the hyperoxemia, this reduction commences within 15 – 90 seconds, and leads to an increased and sustained reduction in FiO2 while the patient remains in the hyperoxemic state.

Initiating Automatic Control of Oxygen Settings for the Automatic FiO2 Control system are advanced settings of FiO2.

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Controls Automatic C ontrol of F iO 2 – E nable / Dis able (Auto F iO 2) This control activates and de-actives the Automatic FiO2 Control system. When the Automatic FiO2 Control system is disabled, the %O2 setting controls the percentage of oxygen in the delivered gas. When Automatic FiO2 Control is enabled, the system delivers oxygen based on a calculated Target FiO2 that uses the measured SpO2 to maintain the patient’s SpO2 between the SpO2 Target High and Low Limits. When Auto FiO2 is enabled, the Auto FiO2 indicator is displayed. This indicator displays the (operator-set) lower and upper limits of the SpO2 target range (see Figure 1). • Range: On / Off • Default: Off

Figure 1 Auto FiO2 indicator When the Automatic FiO2 Control is disabled, the FiO2 is set to the current %O2 setting. Note: The Automatic Control of FiO2 is only available if the neonatal patient size is selected and pulse oximetry is enabled. Note: The control algorithm targets the midpoint SpO2 Low and SpO2 High. If the patient’s SpO2 is stable and within the target range, but above the midpoint, FiO2 is slowly adjusted downward. If the patient’s SpO2 is within the target range but below the midpoint, FiO2 is not adjusted. Note: The Calculated Minute Volume (Calc Ve) indication is not displayed when Automatic FiO2 Control is Enabled. The FiO2 Monitor and Alarms must be enabled when Automatic FiO2 is enabled.

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Warning! The automatic control algorithm uses the Baseline FiO2 value to determine the Auto FiO2 Command value. Before initiating (or reinitiating) Automatic FiO2 Control, ensure that the FiO2 setting reflects the patient’s current clinical condition to ensure that the control algorithm responds appropriately. Failure to do so affects the response time of the control algorithm. Note: If the current FiO2 exceeds the Low AutoFiO2 Alarm or High AutoFiO2 Alarm threshold when AutoFiO2 is initially enabled, the appropriate alarm activates immediately. In the event the FiO2 was below the Low AutoFiO2 Alarm, FiO2 is increased to that limit value. This implies that the alarm settings already set are inappropriate for the patient and should be changed. S pO 2 T arget L ow (S pO 2 T rgt L ow) The SpO2 Target Low is the lower limit of the range within which the Automatic FiO2 Control System attempts to maintain the patient’s SpO2. • Range: 80 to 98% • Resolution: 1% • Default: 88% S pO 2 T arget High (S pO 2 T rgt High) The SpO2 Target High is the upper limit of the range within which the Automatic FiO2 Control System attempts to maintain the patient’s SpO2. • Range: 82 to 100% • Resolution: 1% • Default: 95% Note: The SpO2 Target Low must be set at least 2% lower than the SpO2 Target High.

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B ac kup F iO 2 The FiO2 control is relabeled Backup FiO2 (see Figure 2). • Range: 21 to 100% • Resolution: 1% • Default: When Automatic FiO2 Control is enabled, the Backup FiO2 is initialized to the current FiO2 setting.

Figure 2 Backup FiO2 control B ias F low (when Auto F iO 2 is ac tive) • Range: 2.0 to 5.0 L/min when Automatic FiO2 is enabled • Resolution: 0.1 L/min • Default: 5.0 L/min Note: When Auto FiO2 is enabled, Avea bias flow is modified to optimize Auto FiO2 performance. The lower limit of the bias flow range is increased from 0.4 to 2.0 L/min and the default is increased from 2.0 to 5.0 L/min.

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Monitors B as eline F iO 2 Baseline FiO2 represents the FiO2 required to maintain the patient in normoxemia (when SpO2 is within the SpO2 Target Low and High range). This value moves very slowly. Baseline FiO2 changes under the below listed circumstances. The rate of automatic change to Baseline FiO2 depends on the patient’s oxygenation status in relation to the target range. • When AutoFiO2 is initiated, the current FiO2 becomes Baseline FiO2. • When SPO2 is within the target range, the rate of change for Baseline FiO2 depends on the SpO2 value. If SpO2 is in the lower half of the target range, Baseline FiO2 remains flat. If SpO2 is in upper half of the target range, baseline weans downward at a rate that increases the higher SpO2 value. In an extreme case (SpO2 at the top of the target range and Baseline FiO2 at 100 percent), baseline will wean at approximately 16 percent per hour. Weaning will be slower (possibly much slower) if Baseline FiO2 is less than 100 percent or if SpO2 is not at the top of the target range. • When SpO2 is below the target range and flat, Baseline FiO2 adjusts toward AutoFiO2 Cmd with a time constant of approximately 30 minutes. For example, in one hour, the baseline will titrate upward from 21 percent to about 84 percent. • When SpO2 is above the target range and flat, Baseline FiO2 adjusts toward AutoFiO2 Cmd with a time constant of approximately 30 minutes. For example, in one hour, the baseline will titrate downward from 100 percent to about 37 percent. • Range: 21 to 100% • Resolution: 1% • Default: When Automatic FiO2 Control is enabled, Baseline FiO2 is initialized to the current FiO2 setting. Warning! The automatic control algorithm uses Baseline FiO2 value to determine the Auto FiO2 Command value. Before initiating (or reinitiating) Automatic FiO2 Control, ensure that the FiO2 setting reflects the patient’s current clinical condition to ensure that the control algorithm responds appropriately. Failure to do so affects the response time of the control algorithm.

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Auto F iO 2 C ommand (Auto F iO 2 C md) The Auto FiO2 Command is the current, instantaneous percentage of oxygen that the ventilator is being commanded to deliver. • Range: 21 to 100% • Resolution: 1% Note: The Auto FiO2 Cmd is not allowed to be lower than the Low Auto FiO2 Limit Alarm. Note: If Increase O2 or Suction is activated, the Automatic FiO2 Control System is overridden for two minutes, or until the respective function is cancelled by the operator. The new FiO2 will be the Auto FiO2 Command (at the time the Increase O2 or Suction button was pressed) plus the increase FiO2 setting.

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Alarms L ow Auto F iO 2 L imit The Low Auto FiO2 Alarm is activated if the targeted FiO2 is at, or lower than, this setting for 60 seconds or more. The closed-loop controller will not target an FiO2 below this setting. This is a high-priority alarm. • Range: 21 to 100%, Off • Resolution: 1% • Default: 21% High Auto F iO 2 Alarm The High Auto FiO2 Alarm is activated if the targeted FiO2 is at, or higher than, this setting for 60 seconds or greater. The closed-loop controller will target an FiO2 above this setting as needed. This is a high-priority alarm. • Range: 21 to 100%, Off • Resolution: 1% • Default: 70% Note: The High and Low Auto FiO2 alarms may only be disabled if the High and Low SpO2 alarms are set (not disabled). Note: The Low AutoFiO2 Alarm and the High AutoFiO2 Alarm are each activated immediately if you change the alarm setting such that the alarm is exceeded. If you increase the Low AutoFiO2 Limit above the AutoFIO2 Command, the alarm activates and AutoFIO2 Command increases to the new Low AutoFiO2 Limit setting. If you set the High AutoFiO2 Limit below AutoFIO2 Command, the alarm activates and AutoFIO2 Command will not change. L ow S pO 2 Alarm The Low SpO2 Alarm is activated if the measured SpO2 is at, or lower than, this setting for more than the SpO2 Alarm Delay setting. This is a high priority alarm. • Range: 60 to 97%, Off • Resolution: 1% • Default: 87%

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