Dräger Fabius Series Manual
Anesthesia devices for long-term ventilation
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Also See for Fabius Series:
- Disassembly/assembly (2 pages) ,
- Supplement to instructions for use (142 pages)
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Drägerwerk AG & Co. KGaA, 23542 Lübeck
To Dräger Customers and
Health Care Professionals
in the United States of America
COVID-19: Usage of Dräger anesthesia devices for long-term ventilation
Dear Customers and Health Care Professionals,
The World Health Organization (WHO) declared COVID-19 a pandemic on March 11
over 2,600,000 confirmed cases of the coronavirus illness reported in over 180 countries worldwide. The
pandemic has created a high demand for mechanical ventilation that may exceed the number of available ICU
ventilators in hospitals treating patients with the disease. In the last few days, many customers and health care
professionals have approached us to obtain information about possibly using Dräger anesthesia devices for
long-term ventilation as an alternative ventilator for ICU patients when existing devices are fully utilized and
there is no other ventilator option.
Drägerwerk AG & Co. KGaA
Bank details:
Moislinger Allee 53-55
Commerzbank AG, Lübeck
23558 Lübeck, Germany
IBAN: DE95 2304 0022 0014 6795 00
Swift-Code: COBA DE FF 230
Postal address:
Sparkasse zu Lübeck
23542 Lübeck, Germany
IBAN: DE15 2305 0101 0001 0711 17
Tel +49 451 882-0
Swift-Code: NOLADE21SPL
Fax +49 451 882-2080
info@draeger.com
www.draeger.com
Please visit the Dräger COVID-19 website
https://www.draeger.com/en-
us_us/Home/novel-coronavirus-outbreak
for updates and other useful information
Registered office: Lübeck
Commercial register:
Local court Lübeck HRB 7903 HL
General partner: Drägerwerk Verwaltungs AG
Registered office: Lübeck
Commercial register:
Local court Lübeck HRB 7395 HL
Our reference
COVID-19 – Draeger, Inc
Phone
1-800-4-DRAGER
E-mail
remosaus
@draeger.com
April 24
th
, 2020 with currently
Chairman of the Supervisory Board
for Drägerwerk AG & Co. KGaA and
Drägerwerk Verwaltungs AG:
Stefan Lauer
Executive Board:
Stefan Dräger (chairman)
Rainer Klug
Gert-Hartwig Lescow
Dr. Reiner Piske
Anton Schrofner
th
2020
Rev. 5
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Table of Contents
Related Manuals for Dräger Fabius Series
Summary of Contents for Dräger Fabius Series
- Page 1 Drägerwerk AG & Co. KGaA, 23542 Lübeck Our reference COVID-19 – Draeger, Inc To Dräger Customers and Health Care Professionals Phone 1-800-4-DRAGER in the United States of America E-mail remosaus @draeger.com Please visit the Dräger COVID-19 website https://www.draeger.com/en- us_us/Home/novel-coronavirus-outbreak for updates and other useful information April 24 2020 COVID-19: Usage of Dräger anesthesia devices for long-term ventilation...
- Page 2 Page 2 / 38 Under these special circumstances, we believe it is our responsibility to provide some insights both (i) on the legal and regulatory perspective as well as (ii) on some known limitations of Dräger anesthesia devices for long-term ventilation. If you have any questions or comments, please do not hesitate to contact your local Dräger representative.
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Page 3: Table Of Contents
Page 3 / 38 Index Legal and regulatory perspective ......................5 Known limitations of Dräger anesthesia devices regarding use in long-term ventilation ..... 6 General instructions ........................6 Prerequisites & preparation ....................... 6 Training of medical personnel ....................6 Location requirements ......................7 Manual resuscitator ......................... - Page 4 Page 4 / 38 Patient-specific limits for all alarms ..................18 Alarm notifications ......................... 19 Gas measurement ......................... 19 4.7.1 ........................... 19 Endotracheal suctioning in a closed system ................19 Nebulization of drugs and aerosol therapy ................20 4.10 In case of failure ........................20 Consumption of fresh gas and soda lime ................
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Page 5: Legal And Regulatory Perspective
Page 5 / 38 Legal and regulatory perspective The intended use of each Dräger anesthesia device is described in the relevant instructions for use. Although the wording of the intended use may vary among the devices, the content is very similar: The devices are specified for use during surgical or diagnostic interventions under the constant supervision of the user(s). -
Page 6: Known Limitations Of Dräger Anesthesia Devices Regarding Use In Long-Term Ventilation
Page 6 / 38 Known limitations of Dräger anesthesia devices regarding use in long-term ventilation WARNING: The following information is based on our currently available knowledge as of the date of this letter. It only applies to Dräger anesthesia devices still being marketed. It is most likely not complete or exhaustive. -
Page 7: Location Requirements
Page 7 / 38 Before connecting a patient, the user must be able to check the proper device status, ensure that all accessories (e.g. ventilation hoses, bacteria filter, gas sampling line, manual breathing bag, water traps) are properly connected and that the device is able to generate gas flow and pressure at the patient connector. -
Page 8: Oxygen Backup Cylinder
Page 8 / 38 Oxygen backup cylinder In case of shortages or loss of central gas supply, Dräger anesthesia devices will continue with mechanical ventilation. Shortages will lead to alarms of the anesthesia, please refer to the instructions for use and check under the chapter “Fault - Cause - Remedy”. To ensure the desired FiO2 level, an O2 backup cylinder is required. -
Page 9: Infection Prevention
Page 9 / 38 Infection prevention Regarding infection prevention, hospital guidelines have to be followed. This includes the reprocessing of the device after usage on infectious patients (particularly the device surfaces) but also the adequate use of bacteria filters. More information regarding infection prevention in the context of COVID-19 is provided in the Dräger 2019-nCoV infection prevention customer letters for anesthesia and intensive care and their supplements, please refer to the following website:... - Page 10 Page 10 / 38 Two different solutions for the use of mechanical filters are recommended: Solution 1 – Passive humidification Use of a combined element: Heat and Moisture Exchanger (HME) / mechanical breathing system filter (e.g. Dräger TwinStar HEPA) ...
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Page 11: Breathing Bag
Page 11 / 38 Breathing bag The breathing bag of Dräger anesthesia devices acts as a reservoir during mechanical ventilation. The exhaled breathing gas is captured in the breathing bag. Therefore, the breathing bag moves during mechanical ventilation. The capacity of the breathing bag should always be sufficient. -
Page 12: System Configuration / Default Settings
Page 12 / 38 detected by an increasing inspiratory CO measurement or a change in color (purple) of the Dräger CO absorber (see instructions for use of anesthesia device and CO -absorber for more information). Generally the absorber will absorb CO and thus change color from the bottom to the top. -
Page 13: Regular Checks
Page 13 / 38 gas mixer), units (e.g. for etCO ), activation of alarm entries in the device logbook, and set entry interval to ≤ 2 minutes (Perseus and Apollo). The adaption of default settings can only be done in standby and is protected by a password. For adapting the settings, please contact the responsible person in your organization and check the instructions for use. -
Page 14: System Restart & Refreshing Internal Memory
Page 14 / 38 To perform the system test, the patient must be disconnected from the anesthesia device. During this time, sufficient ventilation of the patient (e.g. via the resuscitator) has to be ensured. Because the system test takes up to 8 minutes (depending on the device type), the assistance of an experienced user is required for this step. -
Page 15: Therapy
Page 15 / 38 heat and moisture exchangers hoses, and excessive condensation at filters and HMEs ( ) that may lead to increased resistance. Attachment 7: Decision If a shortage (e.g. of accessories) exists or is unavoidable, refer to support in case of supply shortages . Therapy Fresh gas flow 4.1.1 General recommendation –... - Page 16 Page 16 / 38 condensation may block filters in the patient circuit (especially a filter at the inspiratory port) Therefore, we recommend that you: Do not to use a fresh gas flow less than 20% of the minute volume of the patient or less than 1 L/min.
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Page 17: Handling Leakages
Page 17 / 38 Handling leakages In general, leakages are not compensated by Dräger anesthesia devices. This has to be considered by the user, especially during all volume controlled ventilation modes. Otherwise, insufficient ventilation situations may occur. If leakages can’t be avoided, the Pressure Control mode has an advantage in that it delivers the set inspiratory pressure independently of any leakage as long as the capacity of the breathing bag is sufficient. -
Page 18: Discouraged Use - External Fresh Gas Outlet, Pause, And Monitoring Mode
Page 18 / 38 mechanical ventilation, the APL valve always has to be set to a value suitable for the patient. When setting the APL valve to the desired PEEP level (or alternatively SPONT, which equals zero), you prevent excessive airway pressures from being applied to the patient in the event of a ventilator failure. - Page 19 Page 19 / 38 In contrast to most ICU ventilators some Dräger anesthesia devices also have an adjustable Paw low alarm limit. This alarm limit has to be set either to “automatic” / “AUTO” (if available) or between PEEP and inspiratory pressure / plateau pressure to detect unintentionally applied continuous airway pressures as well as intrinsic PEEP situations.
- Page 20 Page 20 / 38 reduce the power-setting of the suction system accordingly if suctioning in a closed system / in-line suctioning or any other PEEP-saving suctioning procedures. If in doubt, disconnect the anesthesia device for endotracheal suctioning (consider the loss of PEEP). Alternatively, by disconnecting the manual breathing bag you can ensure that the bag won’t collapse due to the suctioning.
- Page 21 Page 21 / 38 For a rough estimation of the consumption of fresh gas please refer to the calculation sheet provided on the following website: https://www.draeger.com/en-us_us/Home/novel-coronavirus- outbreak Oxygen concentrator “O 93” The use of concentrated oxygen (“O 93”) is not approved with Dräger anesthesia devices. In case of shortages of pure oxygen, “O 93”...
- Page 22 Page 22 / 38 Attachments Attachment 1: Comments on particular modes of operation ..........23 Attachment 2: Overview of Ventilation Modes ............... 24 Attachment 3: Dräger Fabius Family with Installed Fresh Gas Outlet (FGO) ......26 Attachment 4 – Active Gas Scavenging (AGS) alternatives ..........27 Attachment 5: Increasing fresh gas flow by opening the emergency O2 flow control ...
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Page 23: Attachment 1: Comments On Particular Modes Of Operation
Page 23 / 38 Attachment 1: Comments on particular modes of operation Volume Control and VC-AutoFlow: In most ICU ventilators the upper airway pressure alarm limit “Paw-high” is not only used for generating the airway pressure high alarm but also for limiting the maximum pressure generated by the therapy device. -
Page 24: Attachment 2: Overview Of Ventilation Modes
Page 24 / 38 Attachment 2: Overview of Ventilation Modes Overview of Ventilation Modes in Critical Care Ventilators and Terms Used in Different Dräger Anesthesia Devices Possibly your device does not dispose of all described modes – sometimes they are not ordered in the device configuration. - Page 25 Page 25 / 38 Overview of Ventilation Modes in Critical Care Ventilators and Terms Used in Different Dräger Anesthesia Devices Possibly your device does not dispose of all described modes – sometimes they are not ordered in the device configuration. Perseus A500: Mode name ICU ventilator Mode key name Perseus...
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Page 26: Attachment 3: Dräger Fabius Family With Installed Fresh Gas Outlet (Fgo)
Page 26 / 38 Attachment 3: Dräger Fabius Family with Installed Fresh Gas Outlet (FGO) FGO variant A FGO variant B Different variants of the FGO exist. Please ensure that the switch of FGO variant A is at the COSY position, as shown in the picture. -
Page 27: Attachment 4 - Active Gas Scavenging (Ags) Alternatives
Page 27 / 38 Attachment 4 – Active Gas Scavenging (AGS) alternatives To avoid oxygen accumulation in the direct environment of the device, a proper scavenging is recommended although no anesthetic agent is used. If no AGS is available and the anesthesia device has the outlet of surplus gases behind doors, the doors must be left open to avoid oxygen accumulation. -
Page 28: Attachment 6: Fresh Gas Settings
Page 28 / 38 Attachment 6: Fresh gas settings [L/min] Total FG-Flow 2.5 Total FG-Flow 5 Total FG-Flow 10 Total FG-Flow 15 Desired FG-O FG-Flow FG-Flow FG-Flow FG-Flow FG-Flow FG-Flow FG-Flow FG-Flow Concentration 0.15 2.35 14.1 13.2 0.45 2.05 12.3 11.4 0.95 1.55... -
Page 29: Attachment 7: Decision Support In Case Of Supply Shortages
Page 29 / 38 Attachment 7: Decision support in case of supply shortages This chapter gives decision support for the case of supply shortages during the use of anesthesia devices for long-term ventilation. IMPORTANT: In general, the advice and recommendations in the customer letter “COVID-19: Usage of Dräger anesthesia devices for long-term ventilation”... - Page 30 Page 30 / 38 Index for Attachment 7 Initial situation and consequences ..................31 Shortage in IV medication for sedation .................. 31 Central gas supply shortage....................31 Very high CO -absorber consumption due to high minute volumes ........32 Too much humidity in the breathing system ................. 32 No fresh soda lime available....................
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Page 31: Initial Situation And Consequences
Page 31 / 38 Initial situation and consequences Initial situation according to the customer letter “COVID-19: Usage of Dräger anesthesia devices for long- term ventilation”. That means: high fresh gas flow 1.5xMV no volatile anesthetic agent soda lime at the device ... -
Page 32: Very High Co -Absorber Consumption Due To High Minute Volumes
Page 32 / 38 If the entire gas supply (central supply and cylinders) fails, the breathing bag (including the hose between the breathing bag and the breathing system or the flexible breathing bag arm) must be removed from the breathing system. The anesthesia device will continue mechanical ventilation with room air with 21 % FiO2 (volatile anesthetic agent will not be delivered). -
Page 33: No Fresh Soda Lime Available
Page 33 / 38 Use a breathing hose system with water traps that is as long as possible For Clic-absorber, replace it earlier than usually (at least, if 2/3 of its content has turned purple) –absorber, fill only half of the specified content; in this case change the Use reusable CO soda lime if it completely changed its color to purple or inspiratory CO2 is detected;... -
Page 34: Decision Tree
Page 34 / 38 Decision tree... -
Page 35: Only Soda Lime Of Lower Quality (Granular Soda Lime) Is Available
Page 35 / 38 (a) If a shortage of the fresh gas delivery occurs (fresh gas flow < 150% of minute volume) rebreathing will increase with a significant inspiratory CO2 and reduced FiO2 concentration. (b) FiO2 will decrease due to entrainment of ambient air. No manual support of patient breathing via Man / Spon possible. -
Page 36: No Sample Gas Line Is Available
Page 36 / 38 No sample gas line is available Use infusion line or CO measurement line with LuerLock Gas measurement might be affected, especialy when applying higher respiratory rates and lower tidal volumes Alarms like „sample line blocked“ or „sample line disconnected?” might appear 10 No breathing system filter is available General information on the filter setup and necessary reprocessing measures are in the customer letter “SARS-CoV-2 and handling of Dräger Anesthesia Workstations“,... -
Page 37: Decision Tree
Page 37 / 38 10.1 Decision tree... -
Page 38: No Disposable Breathing Circuit Is Available
Page 38 / 38 11 No disposable breathing circuit is available Use reusable breathing hose systems, whenever possible with water traps. 12 Reduce the fresh gas flow Fresh gas flow > 20% of the minute volume, at least 1 L/min. For patients with increased CO production (e.g.