Addendum
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U.S. Patents: www.covidien.com/patents. © 2020 Covidien. COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owner. Other brands are trademarks of a Covidien company. The information contained in this addendum is the sole property of Covidien and may not be duplicated without permission. This addendum may be revised or replaced by Covidien at any time and without notice. Ensure this addendum is the most current applicable version. If in doubt, contact Covidien’s technical support department. While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment. The ventilator should be operated and serviced only by trained professionals. Covidien’s sole responsibility with respect to the ventilator and software, and its use, is as stated in the limited warranty provided. Nothing in this document shall limit or restrict in any way Covidien’s right to revise or otherwise change or modify the equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the contrary, Covidien has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its software) described herein. Covidien is a Medtronic company.
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Table of Contents 1 Software Enhancements... 3 Overview... 3 Update to Table 11-9 Ventilator Settings Range and Resolution... 3 Update to Table 11-10 Alarm Settings Range and Resolution... 3 Update to Section 10.15.1 Apnea ventilation... 3 Update to Table 11-9 Ventilator Settings Range and Resolution... 3 Update to Section 3.7.3 Stand-By State... 4 Update to Section 10.13.2 Disconnect... 4 Update to Section D.8.3 Elevate O2... 4 Update to Table 6-5. Non-technical Alarm Summary... 5 Update to Table 6-6. Non-technical Alarms and Suggested Responses... 5
Operator's Manual Addendum
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1. Software Enhancements 1.1. Overview This addendum describes enhancements to the 980 Ventilator System and changes to the 980 Ventilator System Operator’s Manual.
1.2. Update to Table 11-9 Ventilator Settings Range and Resolution Setting
Description
Range and resolution
Apnea interval (TA)
The time after which the ventilator transitions to apnea ventilation TA ≥ 60/fA
Range: 3 s to 60 s or OFF in CPAP Resolution: 1 s
1.3. Update to Table 11-10 Alarm Settings Range and Resolution Setting
Description
Apnea interval (TA)
The apnea alarm condition indicates Range: 3 s to 60 s or OFF in CPAP that neither the ventilator nor the Resolution: 1 s patient has triggered a breath for the operator-selected apnea interval (TA). When the apnea alarm condition is true, the ventilator invokes mandatory ventilation as specified by the opera- tor.
Range and resolution
1.4. Update to Section 10.15.1 Apnea ventilation Because the minimum value for TA is 3 seconds, apnea ventilation cannot take place when non-apnea f is greater than or equal to 18/min. The ventilator does not enter apnea ventilation if TA is equal to the breath period interval. Set TA to a value less than the expected or current breath period interval as a way of allowing the patient to initiate breaths while protecting the patient from the consequences of apnea.
1.5. Update to Table 11-9 Ventilator Settings Range and Resolution Setting
Description
Range and resolution
mL/kg ratio
The default tidal volume/ PBW ratio (only adjustable in Service Mode)
Range: 4.0 mL/kg to 10 mL/kg Resolution: 0.5 mL/kg
Operator's Manual Addendum
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1.6. Update to Section 3.7.3 Stand-By State Stand-By state can be used when the clinician needs to disconnect the patient for any reason (prior to transporting a patient, for example). The ventilator enters Stand-By state if a request is made by the clinician, a patient is disconnected within a fixed time period determined by the ventilator software, and the clinician confirms the patient has been disconnected intentionally. If a patient becomes disconnected from the patient circuit after the time period elapses, an alarm sounds and the patient-disconnect sequence is initiated. In Stand-By state, gas output is reduced to 10 L/min to limit gas consumption and to allow for detection of patient reconnection. Stand-By state is available in all ventilation modes except during inspiratory and expiratory BUV, occlusion status cycling (OSC), safety valve open (SVO), or ventilator inoperative (vent inop) conditions. Note: Do not block patient circuit wye while in Stand-By state. If the wye is blocked, the ventilator detects a patient connection and will attempt to resume normal ventilation. To enter Stand-By state 1. Touch the Menu tab on the left side of the GUI. The menu appears. 2. Touch Stand-By. A Stand-By state pending dialog appears instructing the clinician to disconnect the patient circuit. A timer starts allowing 30 seconds to disconnect the patient. 3. Disconnect the patient circuit and confirm the disconnection by touching Confirm. A timer starts allowing 30 seconds for confirmation of disconnect. To exit Stand-By state Reconnect the patient circuit. The ventilator resumes ventilation at the settings in use before the disconnection. The following ventilator setting becomes active during Stand-By state: • Base flow is set to 10 L/min
1.7. Update to Section 10.13.2 Disconnect Once the ventilator detects a patient circuit disconnect, the ventilator declares a highpriority alarm and discontinues breath delivery, regardless of what mode (including apnea) was active when the disconnect was detected. If there is an active audio paused interval when the disconnect occurs, the audio paused interval is not canceled. The ventilator displays the length of time the patient has been without ventilatory support. During the disconnect, the exhalation valve closes, idle flow (10 L/min flow with Leak Sync disabled and 20 L/min with Leak Sync enabled) begins, and breath triggering is disabled. A message appears identifying how long the patient has gone without ventilatory support.
1.8. Update to Section D.8.3 Elevate O2 In NeoMode 2.0, the elevate O2 control works as described in Chapter 3.
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Operator's Manual Addendum
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1.9. Update to Table 6-5. Non-technical Alarm Summary Base message
Priority
Analysis message
Remedy message
Comments
INOPERATIVE BATTERY
Low
Inadequate charge or non- Service/replace ventilator functional ventilator bat- battery. tery system.
INOPERATIVE BATTERY
Low
Inadequate charge or non- Service/replace compres- functional compressor sor battery. battery system.
INOPERATIVE BATTERY
Low
Inadequate charge or nonfunctional ventilator bat- tery system. Inadequate charge or nonfunctional compressor battery system.
INOPERATIVE BATTERY
Medium
Inadequate charge or non- Service/replace ventilator functional ventilator bat- battery. tery system.
INOPERATIVE BATTERY
Medium
Inadequate charge or non- Service/replace compres- functional compressor sor battery. battery system.
INOPERATIVE BATTERY
Medium
Inadequate charge or nonfunctional ventilator bat- tery system. Inadequate charge or nonfunctional compressor battery system.
Battery installed but not functioning or charging for ≥ 6 hours. Resets when battery is functional.
Service/replace ventilator battery. Service/replace compres- sor battery.
Defective battery detec- ted. Corrective actionReplace battery as soon as possible.
Service/replace ventilator battery. Service/replace compres- sor battery.
1.10. Update to Table 6-6. Non-technical Alarms and Suggested Responses Alarm Message
Meaning
Response
INOPERATIVE BATTERY
Alarm indicates unable to charge battery or the battery system is nonfunctional.
Replace inoperative battery.
Operator's Manual Addendum
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*PT00128083*
© 2020 Covidien. PT00128083 Rev. A 2020-09-17