Dräger Perseus A500 Скачать руководство пользователя страница 2

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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. As mentioned, feedback is highly appreciated and enables us to share new information

about this subject with medical caregivers worldwide.

With kind regards,

Ines Thams

Ralf Heesch

Moritz Rahlf-Luong

Risk Manager

System Engineer

Product Management Anesthesiology

Содержание Perseus A500

Страница 1: ...of America April 24th 2020 COVID 19 Usage of Dräger anesthesia devices for long term ventilation Rev 5 Dear Customers and Health Care Professionals The World Health Organization WHO declared COVID 19 a pandemic on March 11th 2020 with currently 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 ve...

Страница 2: ...sthesia devices for long term ventilation If you have any questions or comments please do not hesitate to contact your local Dräger representative As mentioned feedback is highly appreciated and enables us to share new information about this subject with medical caregivers worldwide With kind regards Ines Thams Ralf Heesch Moritz Rahlf Luong Risk Manager System Engineer Product Management Anesthes...

Страница 3: ...Filters humidification 9 2 9 Breathing bag 11 2 10 Water Trap Waterlock 2 11 2 11 CO2 absorber 11 2 12 System configuration default settings 12 3 Regular checks 13 3 1 System Test 13 3 2 System restart refreshing internal memory 14 3 3 Check for overall status and accessories 14 4 Therapy 15 4 1 Fresh gas flow 15 4 1 1 General recommendation high fresh gas flow 15 4 1 2 Additional fresh gas flow 1...

Страница 4: ...nts at Y piece not recommended 21 8 Ventilating multiple patients with one device not recommended 21 9 Attachments 22 9 1 Attachment 1 Comments on particular modes of operation 23 9 2 Attachment 2 Overview of Ventilation Modes 24 9 3 Attachment 3 Dräger Fabius Family with Installed Fresh Gas Outlet FGO 26 9 4 Attachment 4 Active Gas Scavenging AGS alternatives 27 9 5 Attachment 5 Increasing fresh ...

Страница 5: ...their own responsibility and at his own liability risk However in a situation in which a patient requires long term mechanical ventilation but cannot be ventilated due to a lack of intensive care ventilators the benefit of being able to ventilate such a patient with a Dräger anesthesia device has to be weighed against the risk of the off label usage of a Dräger anesthesia device This risk benefit ...

Страница 6: ... under their own responsibility and at their own liability risk 1 General instructions The following proposals support the targets that the off label use is as safe as possible and that as many anesthesia devices as possible will maintain their ventilation capacities even under long term ventilation Refer to the following website https www draeger com en us_us Home novel coronavirus outbreak for a...

Страница 7: ...and gas can flow out see e g website of European Patient Safety Foundation https www eupsf org safety alert wrong tube connections 2 2 Location requirements Anesthesia devices should be used only in rooms with adequate ventilation The user interface of Dräger anesthesia devices cannot be protected against non authorized users Therefore the operating organization must ensure that non authorized use...

Страница 8: ...nt is used For more information see Attachment 4 Active Gas Scavenging AGS alternatives 2 6 Disconnection of vaporizers N2O In order to prevent the use of anesthetic agents in a situation that might harm the patient or the patient s environment it is recommended that you disconnect all vaporizers from the anesthesia device and store them in the operation room This is particularly important because...

Страница 9: ...e Dräger 2019 nCoV infection prevention customer letters for anesthesia and intensive care and their supplements please refer to the following website https www draeger com en us_us Home novel coronavirus outbreak 2 8 Filters humidification Only mechanical filters are suitable in long term ventilation because with electrostatic filters the filtering performance is reduced when they become too humi...

Страница 10: ...create excessive condensation in the breathing system of the anesthesia device Breathing circuits require a water trap in the expiratory limb Dual heated breathing circuits must not be used with Dräger anesthesia devices Also the use of filters or even HME filters at the Y piece must be avoided to prevent excessive breathing resistance due to clogged filters resp HME filters during active humidifi...

Страница 11: ...er trap has to be emptied or exchanged before it becomes full Please refer to the IFU for how to drain the water trap The required frequency of doing this depends on the humidity of the sample gas For usage of the Dräger anesthesia device with high fresh gas flows and a combined HME mechanical filter we expect that the filling level has to be checked every 12 hours If using the recommended filter ...

Страница 12: ...f at least 150 of the minute volume of the patient there will only be limited rebreathing and therefore the absorber will last a longer time Nevertheless the absorber should be changed every 7 days regardless of whether the absorption capacity has been spent Only use Dräger absorber due to minimal dust emission If using Perseus A500 with a reusable absorber please always use a fresh dust filter wh...

Страница 13: ...he device test is not done the readiness of operation is not tested and particularly the flow measurement may become inaccurate In general never rely on a single measured value for clinical decisions Unlike many ICU ventilators the flow measurement of the anesthesia device cannot be calibrated during operation Measured values may change their color to indicate an inaccurate status The accuracy of ...

Страница 14: ...memory To prepare the software clean internal memory components of a Dräger anesthesia system for long term ventilation we recommend that you restart switch the device off and on again at the user interface the device before preparing it for a new patient o Perseus A500 A restart is required after 28 days but only after switching to standby Starting operation again will only be possible in that si...

Страница 15: ...s to fresh gas settings and refer to chapter 5 for gas consumption 4 1 2 Additional fresh gas flow When using Perseus A500 with electronic gas mixer the fresh gas flow can be additionally increased by opening the emergency O2 flow control Please refer to Attachment 4 Active Gas Scavenging AGS alternativesAttachment 5 Increasing fresh gas flow by opening the emergency O2 flow control This gas is ad...

Страница 16: ...alarm limit for FiO2 low with adequate buffer because the difference between the set fresh gas flow and the FiO2 will increase and the system will react far slower to modifications of the O2 setting o Set an alarm limit for inspiratory CO2 high to an appropriate value o If required update the default settings refer to chapter 2 12 o Check the following parts for humidity more regularly at least ev...

Страница 17: ...nd increases the availability of ventilation In this case the resulting inspiratory oxygen concentration will be between the set fresh gas oxygen concentration and the 21 of the ambient air If the fresh gas flow is high less ambient air is entrained and the inspiratory oxygen concentration increases 4 3 Modes of operation Modes measurement values settings maneuvers etc that are possibly used with ...

Страница 18: ...larm and safety systems of Dräger anesthesia devices are designed for the user to always be within 4 meters 13 feet of the device This allows the user to quickly recognize and respond in the event of an alarm or malfunction Thus the alarm volume always has to be set to a sufficiently loud level particularly in noisy environments The alarm distribution via serial interface is not designed in a redu...

Страница 19: ...ed in the device always has to be connected Unlike many ICU ventilators the gas measurement of anesthesia devices is a side stream monitoring Therefore the gas measurement values and waveforms have a delay of several seconds 4 7 1 FiO2 The rebreathing of exhaled patient gases is a significant difference from ICU ventilators The oxygen concentration of the inhaled gas measured as FiO2 may differ fr...

Страница 20: ...ice malfunctions are very likely to occur e g incorrect measurement of the gas analyzer erroneous measurement of expiratory flows tidal and minute volumes If no mechanical filter is used on the Y piece disconnect the sampling gas line during nebulization and aerosol therapy 4 10 In case of failure If a main component of the anesthesia device such as the mixer ventilator or screen shows a failure i...

Страница 21: ...er for reaction of the user as an overload of an oxygen concentrator may result in lower oxygen concentration of the provided supply gas Some accuracy values required by the anesthesia workstation standards may not be fully achieved e g patient flow measurement fresh gas flow and fresh gas concentration 7 Direct injection of volatile agents at Y piece not recommended Systems for direct injection o...

Страница 22: ...es 24 9 3 Attachment 3 Dräger Fabius Family with Installed Fresh Gas Outlet FGO 26 9 4 Attachment 4 Active Gas Scavenging AGS alternatives 27 9 5 Attachment 5 Increasing fresh gas flow by opening the emergency O2 flow control 27 9 6 Attachment 6 Fresh gas settings 28 9 7 Attachment 7 Decision support in case of supply shortages 29 ...

Страница 23: ...ium priority As in long term ventilation the user might not be permanently in front of the device so the medium alarm priority is recommended Dräger anesthesia devices have no dedicated apnea time and apnea back up ventilation mode as it is available in most ICU ventilators As minute volume in this case will decrease the operator has to react and choose an appropriate ventilation mode or adapt ven...

Страница 24: ...llo Mode name on screen Apollo VC CMV Vol mode Volume VC SIMV Activate Trigger parameter Volume Sync VC SIMV PS Activate Pps parameter Volume Sync PressSupp VC CMV AutoFlow Vol AF mode Volume AF VC SIMV AutoFlow Activate Trigger parameter Volume AF Sync VC SIMV PS AutoFlow Activate Pps parameter Volume AF Sync PressSupp PC CMV Press mode Pressure PC SIMV Activate Trigger parameter Pressure Sync PC...

Страница 25: ...selection Sync on Volume Control SIMV AF VC SIMV PS AutoFlow Activate PS parameter Volume Control SIMV AF PS PC CMV Pressure Control selection Sync off Pressure Control CMV PC SIMV selection Sync on Pressure Control SIMV PC SIMV PS Activate PS parameter Pressure Control SIMV PS PC APRV Press Ctrl APRV Pressure Control APRV SPN CPAP PS Pressure Support CPAP Pressure Support SPN CPAP Pressure Suppor...

Страница 26: ... A is at the COSY position as shown in the picture We also recommend that you secure the switch in the COSY position to prevent unintentional switching by using tape for example In Variant B please ensure that the fresh gas connection from the FGO to the COSY breathing system is installed properly For further details please refer to the IFU and watch https www youtube com watch v Sw5idUnpIZg ...

Страница 27: ... 5 Increasing fresh gas flow by opening the emergency O2 flow control Follow the description below to additionally increase the fresh gas flow by opening the emergency O2 flow control This additional gas is added to the already set fresh gas flow of the mixer As only oxygen will be added the FiO2 will increase An alarm will occur the priority can be reduced by resetting the alarm Perseus electroni...

Страница 28: ... 1 25 2 5 2 5 5 5 7 5 7 5 80 1 85 0 65 3 7 1 3 7 4 2 6 11 1 3 9 100 2 5 0 5 0 10 0 15 0 Example Patient with ARDS ideal bodyweight IBW 80 kg protective tidal volume 6 ml kgBW Fresh Gas O2 Concentration 40 Fresh Gas Flow 150 of Minute Volume Expected Minute Volume IBW x 6 ml kg x Respiratory Rate Expected Minute Volume 80 kg x 6 ml kg x 14 min 480 ml x 14 min 6 7 L min Fresh Gas Flow Expected Minut...

Страница 29: ...aken into account The following remarks should only be considered as an ultima ratio if a corresponding supply bottleneck exists or is unavoidable Depending on the therapy goal and the available options the alternatives given and the associated consequences must be weighed by the responsible user possibly together with users who are very familiar with the anesthesia devices used The sequence of th...

Страница 30: ...much humidity in the breathing system 32 6 No fresh soda lime available 33 6 1 Decision tree 34 7 Only soda lime of lower quality granular soda lime is available 35 8 No fresh water trap for the gas measurement Waterlock2 is available 35 9 No sample gas line is available 36 10 No breathing system filter is available 36 10 1 Decision tree 37 11 No disposable breathing circuit is available 38 12 Red...

Страница 31: ... active AGS additional to the fresh gas flow IV medication needed for sedation Low soda lime consumption Drying out of the soda lime but no patient harm e g compound formation as no volatile anesthetic agent must be used No room air contamination Reduced humidity in the circle system 2 Shortage in IV medication for sedation Use alternative IV drugs for sedation Avoid usage of volatile anesthetic a...

Страница 32: ...mergency delivery remove the breathing bag including the hose between the breathing bag and the breathing system or the flexible breathing bag arm Do not use volatile anesthetic agents Without volatile agents you avoid the formation of toxic substances e g Compound A when the CO2 absorber has dried out Always use IV medication With Perseus A500 the FG flow of the electronic gas mixer might be limi...

Страница 33: ...breathing system WARNING Monitor the FiO2 concentration closely as the concentration may decrease due to dilution with ambient air set the FiO2 alarm limit accordingly 6 No fresh soda lime available If possible Ventilate patients with a foreseeable high CO2 production with an ICU ventilator Anesthesia devices should rather be used for patients with an expected normal or lower CO2 production Set th...

Страница 34: ...Page 34 38 6 1 Decision tree ...

Страница 35: ...seus 7 Only soda lime of lower quality granular soda lime is available Use a dust filter on the reusable absorber Part number MX50115 or as an alternative bacterial filter IBF MK02588 Exchange the filter with every change of the soda lime 8 No fresh water trap for the gas measurement Waterlock2 is available Empty the water trap regularly at the latest when it is half full In this case continue usi...

Страница 36: ... General information on the filter setup and necessary reprocessing measures are in the customer letter SARS CoV 2 and handling of Dräger Anesthesia Workstations https www draeger com en us_us Home novel coronavirus outbreak Overview of Dräger filter HME types and abbreviations for the decision tree MF HME Mechanical filter with HME Dräger TwinStar HEPA MF Mechanical filter Dräger SafeStar EF HME ...

Страница 37: ...Page 37 38 10 1 Decision tree ...

Страница 38: ...p no filter at the inspiration port use mechanical filter if possible with HME at the Y piece TwinStar HEPA or SafeStar Set narrow alarm limits for FiO2 MV low Paw high and insp CO2 high Use the longest possible hoses with water traps in the inspiration and expiration limb Perform a system test of the anesthesia devices every 24 h For devices of the Apollo and Fabius famliy remove condensate out o...

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