Getinge Flow-i User manual

mars 25, 2020
Stockholm, Sweden
To whom it may concern
Maquet Critical Care AB
Röntgenvägen 2
S-17154 Solna
Sweden
www.getinge.com
CUSTOMER NOTIFICATION LETTER
COVID-19 Pandemic
Ventilating ICU patients using Flow-i, Flow-c and Flow-e
anesthesia machines
Dear all,
In view of the situation with the coronavirus, Novel Coronavirus (2019-nCoV), and the possibility to
repurpose Flow-i, Flow-c and Flow-e anesthesia machines for use in the ICU as a ventilator only,
Getinge would like to draw your attention to important information in the following three sections:
1. General information and warnings
2. Preparations for use
3. Key system differences (between Flow anesthesia machines and ICU-ventilators)
Rebreathing
Manual and automatic ventilation (MAN/AUTO) and APL
O2flush
Sampling line and watertrap
AGSS (Anesthesia Gas Scavenging System)
Emergency ventilation
Alarms and monitoring
System checkout
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1. General information and warnings
As outlined in the user manuals the Flow family systems are intended for use:
in administrating anesthesia while controlling the entire ventilation of patients with no
ability to breathe, as well as in supporting patients with a limited ability to breathe.
by healthcare professionals, trained in the administration of anesthesia
on neonate to adult patient populations.
hospital environments, except MRI environments.
When not in operation, the systems are designed for in-hospital transport.
The following information is being provided as a guidance. Using the anesthesia device outside of
the intended use as specified in the user manual and as noted above (e.g. long-term ventilation) is
considered off-label use. If the user (health care provider) decides to use the anesthesia device
off-label, he/she is responsible to make this determination and so at his/her own (liability) risk. The
risk benefit assessment has to be made by the responsible health care provider based on the
circumstances. Please also be aware that this information is only intended for the duration of the
COVID-19 emergency.
Maquet Critical Care AB is providing the following information for a better understanding of how the
anesthesia device functions so that the health care provider can make the decisions on how to
proceed when using a Flow-i, Flow-c and Flow-e anesthesia system for use in the ICU as a
ventilator only.
Please be specifically aware of the following:
-The devices are specified for a usage during surgical or diagnostic interventions under
constant supervision of a trained user. It is therefore important that the personnel using the
anesthesia device is familiar and well trained of the user interface, the controls and the
alarms of the machine or that the user is supervised by someone who is. This has to be
determined by the health care provider based on the situation on the site.
-Certain patients are susceptible to malignant hyperthermia and it is therefore important to
prepare the anesthesia device prior to treating such patients. Make sure to follow the
instructions in the Cleaning and Maintenance Manual (for US - MCV00011319_REVA).
-The User manual states that a resuscitator always must be available at the anesthesia
device to mitigate if any mal-functioning of the device should occur that disturbs the oxygen
intake of the patient.
-The anesthesia device is designed with alarms that are constantly supervised by the user
and safety measures that are dependent on user presence. The healthcare provider must
be aware of this and take appropriate actions so that it is always possible to react on
alarms perform safety measures.
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-Please be aware that nebulization of drugs is not approved with this anesthesia device.
Using aerosol therapy might affect the device negatively causing malfunctinon.
-The anesthesia device is not validated or intended for use with active humidication. Should
this nevertheless be used the HME filter at the y-piece cannot be connected to the system,
as the humidification created will be filtered by the HME filter and will thus not reach the
patient. This will most likely also result in excessive condensate in the anesthesia device. If
active humidification is used the system shall run with high fresh gas flows and be
equipped with filters on both the inspiratory and expiratory limbs and close monitoring of
the ventilatory and patient parameters is mandatory. Dual heated breathing circuits should
not be used.
-If inhalation anesthestic agents are used as sedation the user must be aware of that the
surplus of the agents could be transported out into the environment. It is therefore
important to connect an Anesthesia Gas Scavenging System (AGSS) to the system.
-Reprocessing of applicable parts of the the anesthesia device shall be performed
according to the information in the Cleaning and Maintenance Manual, ie between each
patient after treating a known carrier of pulmonary contagious agents.
-Please ensure that the system has the latest avaliable software installed.
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2. Preparations for use
For more detailed information see section 3 in this letter.
Check that the manual resuscitator is readily available and is working correctly.
Remove the vaporizers by lifting up the front and gently pulling outwards.
If the system is equipped with N2O gas module and/or with the alarm options Mute Apnea Alarms
and/or HLM/CPB (heart lung machine mode/cardio
pulmonary bypass) these should be turned off in the
Service & Settings menu. The alarm modes above will
silence and, for HLM/CPB, disable crucial alarms and
are not to be used in the ICU. Please contact a certified
Getinge trained service engineer to assist.
Connect breathing circuit according to user manual.
Use a high quality antiviral HMEF (heat and moisture
exchange filter) placed between the breathing circuit and the patient’s airway, this will protect the
machine from contamination.
The gas sampling line should be connected to the HMEF on the machine side of the filter to ensure
sampled gas is not contaminated as it enters the water trap.
Make sure to use an expiratory bacterial/viral filter, to minimize cross-contamination. Make sure to
follow the filter manufacturer’s recommendations for exchange interval of the filters.
Perform a system checkout (SCO) according to instructions on screen.The test will take 6-8 minutes.
Back-up gas cylinders are included in the check out procedure should they be connected.
Set alarm sound level to 100% and modify alarm limits accordingly
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3. Key system differences
Rebreathing
The most significant difference between intensive care ventilators anesthesia devices is that
anesthesia ventilators are based on a rebreathing system and adjustable fresh gas flows. This
means that depending on the set fresh gas flow, expired gases will be rebreathed.
If non-rebreathing is desired, we recommend the user to set the fresh gas flow higher than the
patients expired minute volume. If the user to set the fresh gas flow to 20 l/min, the system is
designed to automatically adjust the fresh gas flow to just above the patient’s minute volume and
thus guarantee a non-rebreathing system.
If the fresh gas flow is set to less than expired minute volume, part of the expired gas will be
returned to the inspiratory limb.
In a circlular system, expiratory gas is purified in the CO2 absorber before it is mixed with fresh gas
and delivered to the patient. This requires the use of a CO2absorber to prevent high CO2levels in
the circuit.
Please be aware that if high fresh gas flows are used, the CO2 absorber will not be part of the
breathing circuit and thus not be consumed.
When the gas passes through the soda lime, CO2is absorbed and water and heat are produced. A
higher rebreathing fraction could thus humidify and warm inspiratory gases and may make active
humidification redundant.
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Anesthesia machine operators should change the absorber when the absorption material changes
from white to pink/violet as the measured inspired CO2increases (indicating no more CO2can be
absorbed). The activation of an inspiratory CO2-high alarm limit helps to directly inform the user
about undesired levels of inspiratory CO2 (FiCO2).
Another very important aspect of using rebreathing is that due to patient oxygen consumption and
dilution effects within the circle system, the inspired O2-level might differ to that of the set O2
concentration in the fresh gas delivered from the system. Make sure to continuously
monitor inspired and expired values of O2, (FiO2, EtO2) and CO2(FiCO2and EtCO2).
Should the FiO2decrease below 21% the Flow anesthesia system has a built in safety feature,
O2Guard, that will automatically set the O2setting to 60% and, if set lower, raise the fresh gas flow
to 1 l/min. Please see the User Manual for further information.
Manual and automatic ventilation (MAN/AUTO) - APL
Manual ventilation is carried out using a traditional breathing
bag connected to the patient cassette through a breathing
bag tube. During manual ventilation the ventilator is passive
which means that the patient is not ventilated unless the
manual bag is pressed and the APL is set accordingly.
The MAN/AUTO ventilation switch is an electrical switch
used to select manual or automatic ventilation. The APL
(adjustable pressure limit) valve relieves the patient circuit of
excess pressure at user defined values and ventilates the
gas into the Anesthetic Gas Scavenging System (AGSS).
When the MAN/AUTO switch is set to “MAN” the manual
ventilation valve opens and the manual ventilation bag is
connected to the breathing system.
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O2flush
Pressing the O2flush button manually supplies the system with an additional gas flow of approx. 50
l/min from the O2gas supply. The flow will continue as long as O2flush button is depressed. During
the O2flush activation, the system will hold the set PEEP.
Sampling line and water trap
Always connect the sampling line to the HME-filter located on the endo-tracheal tube, this will
minimize the risk of contaminating the anesthesia machine.
The Flow anesthesia machines are equipped with a side-stream multigas analyzer with an
integrated O2sensor. The length and inner diameter of the sampling line determine how long time it
will take before the gas data and curves information is displayed on the screen. There will, in
other words, be a delay in values and waveforms of several seconds compared to the ICU-
ventilators. Connection of several sampling lines in order to extend the line’s reach will increase
this time.
The water trap, sampling line and connectors are all part of a system optimized for the patient gas
analyzer to protect it from condensed water, secretions, bacterial contamination and dust. The
water trap comprises a filter housing (with hydrophobic anti-bacterial filter), and a water container
for separated waste. The filter housing has one gas sampling inlet that is connected to the
sampling tube.
The sampling line is not reusable and must be replaced between patients or when the cleanliness
of the tubing or connector is compromised.
Check the water trap and sampling line regularly and discard/empty any water present in the water
trap. Empty or discard the water trap after 17 hours of active use, or when half full. The content of
the water trap should be handled as as biological hazardous waste.
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AGSS (Anesthesia Gas Scavenging System)
Caution: If inhalational anesthetic agents are used it is important to ensure that the machine is
connected to a scavenging system as describe in the manual.
When the AGSS is connected to the rear of the system, the flowmeter on the front indicates the
rate of evacuation.The minimum level of evacuation flow is indicated by the floater being above the
dashed area, corresponding to a flow of approx. 25 l/min. If the central scavenging system is
inactive, the gases will be emitted into the room.
Emergency ventilation
Allows patient to be manually ventilated in case of system failure
(i.e mains power and battery) or other electronic failure and is
accessible behind cover on front of machine. Replaces fresh gas
flow (with 100% O2) and electronic APL function.
During emergency ventilation the system cannot deliver anesthetic
agents.
Alarms and monitoring
An anesthesia machine is designed for presence of a trained specialist by it´s side.
There are no lamps or remote monitoring, once an alarm is no longer valid it is not audible
or visible anymore and the sound of the alarms in general are lower than an ICU-ventilator.
Taking this into consideration it is crucial that the clinician in charge has full control of the screen
for the visual alarms and the sound turned up to 100%.
Alarm limits will need to be adapted for each patient.
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The alarm area on the screen can display up to three alarms, listed in order of severity.Should
there be more ongoing alarms a number will be visible to the right (in this case 4). Pressing the
number shows up to 10 ongoing alarms.For previous alarms press “trends” on the same page.
Leakage
Should a leakage occur an alarm will be activated. In general the leakage will not be compensated.
This is especially important during volume controlled ventilation modes. It´s important to find the
source of leakage in order to rectify it as well as following of the patient´s vital signs and ventilation
metrics.
System checkout
To ensure correct system functionality, optimal performance and patient safety, the System checkout
procedure must be performed once a day, or before connecting the first patient within a running 24 hour
period. Should the duration of the treatment exceed this period a message prompting the user to perform a
new system checkout will appear. The system will continue to ventilate independent of this message that will
remain as a reminder. With risk for minor device malfunctiong after 24 h, such as drifting values, it is
possible to continue ventilation for 72 h before conducting System checkout. In order to perform a new
system checkout the system needs to be in Standby and thus the patient needs to be disconnected from the
ventilator and manually ventilated with a resuscitator. The test will take 6-8 minutes Make sure to document
the settings before going to Standby as the machine will reset to startup configurations.
If you have any questions or remarks to this topic, please do not hesitate to contact your local
Getinge representative.
Yours sincerely,
Miray Kärnekull, MD Lena Evander
Medical Director Product Management Anesthesia
Maquet Critical Care AB Maquet Critical Care AB
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