Supplement
Atlan A300, A300 XL, A350, A350 XL
WARNING
To properly use this medical device, read and comply with the instructions for use and this supplement.
Anesthesia workstationSoftware 1.0n
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Supplement to the instructions for use
Atlan A300, A300 XL, A350, A350 XLAnesthesia workstation
Supplement to the instructions for use
● Keep this supplement with the instructions for use.
This supplement updates the information of the instructions for use in the following chapters.
Safety-related information
Essential performance features
The following text has been updated:
Gas measurement
– Breathing gas monitoring:
– Set value for FiO2
– Inspiratory and expiratory measured values for O2, CO2, N2O, and anesthetic gas; automatic anesthetic agent identification (only with the patient-gas measurement module)
The gas composition is measured with ISO accuracy.
– Monitoring of breathing gas concentrations:Alarms will be issued depending on the set alarm limits or if the gas measurement fails.
Overview
Safety functions
Backup manual mode
The following text has been changed:
In various technical fault situations, the backup manual mode enables a direct changeover to manual ventilation in order to continue the therapy. When the backup manual mode is activated, an acoustic and optical alarm signal is issued with high priority. The alarm is automatically downgraded to low priority after 20 seconds (see "Alarm delay, alarm escalation, and alarm deescalation", page 8).
Instructions for use Part number Edition
Atlan A300, A300 XL, A350, A350 XL SW 1.0n
9056001 2 – 2019-04 and higher
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Assembly and preparation
Overview
The following table has been changed:
Assembly and preparation
Safety instructions
Mechanical safety
Accidental movement of the trolley
The remedy for the following safety instruction has been updated:
An unbraked device may accidentally move during operation. As a result, user and patient could be put at risk.
► Prevent this by actuating the central brake and the rear castor brakes, and check their function.
Transport
A remedy has been added to the following safety instruction:
If the device collides with an obstacle during transport, the pressure reducers may be damaged. Take the following measures before transporting:
► If no gas cylinders are connected, fasten the pressure reducers with the hook-and-loop straps of the cylinder holders.
Remedies for the following safety instruction have been updated and added:
During transport, the device may tip over due to incorrect handling or carelessness. Personal injury or property damage may result as a consequence.
► Remove accessories mounted on the column cover before transport.
► When pushing the device, hold on to the standard rail with handle (right side of the device).
► After transport, perform a visual inspection for damage.
Fault Safety function
Mains power supply failure
Uninterruptible power supply provided by internal battery
– Battery operation possible for at least 45 minutes, typically 120 minutes
– Automatic deactivation of the breathing system warmer to increase battery runtime
Supplement | Atlan A300, A300 XL, A350, A350 XL SW 1.0n 5
Assembly and preparation
Electrical safety
Interfaces
The remedy for the following safety instruction has been updated:
Connecting devices to the data interfaces (serial ports and network ports) can lead to an increased leakage current. If the protective ground conductor of one of these devices fails, the patient leakage current may rise above the permissible values. This may result in an electric shock and the user and patient may be at risk.
► Only use USB devices that do not have their own power supply.
► Only connect devices or networks to a serial port, or to the network port, that have a maximum nominal voltage of 24 V DC and meet one of the following standards:
– IEC 60950-1 / IEC 62368-1: Ungrounded SELV circuits
– IEC 60601-1 (as of 2nd edition): Touchable secondary circuits
► Have the leakage current checked by service personnel.
► If the permissible value is exceeded, disconnect the devices from the serial ports.
► Do not touch the interface ports and the patient simultaneously.
Before first operation
Inserting the O2 sensor cell
The following information has been added:
Before inserting the O2 sensor cell, make sure the date and time are correctly set on the device. Otherwise, there may be errors in the lifespan monitoring of the sensor cell.
Intrahospital transport
Increasing the tipping stability during transport
The following steps have been changed:
1. Carefully fold the arms with any mounted accessories against the device, (e.g., patient monitor, data management system, syringe pumps). Insert the additional pull-out work surface. Fold down the additional foldable work surface.
4. Remove all objects from the standard rails.
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Assembly and preparation
Gas supply
Connecting gas cylinders with screw connections
The following step has been added:
Connecting to the gas scavenging system
Active anesthetic gas scavenging
The following step has been changed:
CAUTIONRisk of ambient air contaminationIf the anesthetic gas receiving system is not connected to the disposal system, contamination of the ambient air with anesthetic gas may result.
► Connect the anesthetic gas receiving system correctly to the disposal system.
1. Connect the scavenging hose (1) to the nozzle on the AGS. When an external anesthetic gas monitor is in use, connect the sample gas outlet on the monitor with port (3) using the supplied hose connector.
Selecting and connecting patient-specific accessories
Fitting the breathing circuit and the filters
Permissible hose configurations
The following text has been added:
If a filter is used on the inspiratory port and a very low fresh-gas flow has been set, increased condensate will form in the filter and in the inspiratory flow sensor. This can lead to incorrect flow measurement or to flow measurement failure. Dräger recommends a fresh-gas flow of at least 1 L/min, particularly during minimal-flow anesthesia lasting several hours.
4. If no gas cylinders are connected, secure the pressure reducers (4) with the hook-and-loop straps (3) so they do not bang against the rear of the device.
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Getting started
Connecting a non-rebreathing system
The precautionary statement in the following step has been changed:
WARNINGRisk of excessively high airway pressureWithout a pressure release valve or breathing bag, airway pressure may become too high.
► Only non-rebreathing systems with breathing bags or pressure release valves which comply with ISO 80601-2-13 may be connected.
1. Select a suitable non-rebreathing system.
Getting started
Turning on the device
The following step has been changed:
Operation
Setting and starting the therapy
The following information has been added to step 2:
When the device is equipped with inspiratory O2 measurement and is used in combination with an external anesthetic gas monitor, the extracted sample gas is not fed back into the breathing system.
If this sample gas flow is not taken into consideration when the fresh-gas delivery is set, a lack of fresh gas may result. Increase the fresh-gas flow accordingly, especially for minimal-flow anesthesia and low-flow anesthesia.
The extracted sample gas flow causes a discrepancy between the set inspiratory and the measured expiratory VT. This discrepancy affects the displayed measured values for VT, MV, ∆VT, and MVleak.
Tests
Performing the tests
System test and leakage test
The following text was updated for step 4:
During the automatic system test, the progress of the initialization and the system test is displayed in area (8). Remain by the device during the initialization.
2. Set the main switch to the position.
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Ending operation
Ending operation
Storing the device
The following step has been changed:
Alarms
The following heading has been changed:
Alarm delay, alarm escalation, and alarm deescalation
The following table row has been changed:
Ventilation alarms
The table row has been added:
1. Set the main switch to the position.
Alarm Priority Priority Priority
Note(Low)
Caution(Medium)
Warning(High)
Cardiac bypass mode still active?
--- If a minute volume of >50 % of the suggested value is measured after CBM mode has been activated for >60 seconds
---
Alarm Priority Priority Priority
Note(Low)
Caution(Medium)
Warning(High)
Backup manual mode activated
>20 s --- 0 to 20 s
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Configuration
Configuration
Specifying the start settings
System setup > Therapy
Vertical tab "Fresh gas" (only with electronically controlled gas mixer)
The following table row has been updated:
Troubleshooting
Alarm – Cause – Remedy
The following alarms have been added:
Headline/ Parameter
Setting rangeDescription
Minimal O2 flow (carrier gas: Air)[mL/min]
Off; 50 to 300200
Off; 50 to 300200
Off; 50 to 300200
Sets the minimal O2 flow that is deliv-ered when Air is used as carrier gas.
Do not set the value too low, but suit-able for the patient category. The rec-ommendation is, e.g., 200 for adults, 100 for pediatric patients, and 50 for neonates.
Priority Alarm Cause Remedy
! 255 Expiratory flow sensor failure
Failure of the flow sensor. Replace the flow sensor and perform a leakage test.
! 80 Flow sensor calibration required
The flow sensor calibration is invalid.
Perform the leakage test.
The sensor is not calibrated. The breathing system has been replaced or discon-nected since last calibration.
Perform the leakage test.
! 255 Inspiratory flow sensor failure
Failure of the flow sensor. Replace the flow sensor and perform a leakage test.
! 75 Patient-gas measurement module is calibrating
The automatic calibration of the patient-gas measurement module is in progress.
Wait for the calibration to complete.
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Reprocessing
Reprocessing
Reprocessing procedures
Validated reprocessing procedures
The following information has been added:
Preparation
Disassembling the patient-specific accessories
The following precautionary statement for step 1 has been changed:
WARNINGRisk of infectionUsed sample lines and water traps may be infectious due to the breathing gases that passed through them.
► Replace the sample line regularly in the following situations:
– If the sample line is connected to the filter on the Y-piece, replace it daily.
– If there is no filter fitted to the Y-piece and the sample line is connected directly to the Y-piece, replace the sample line after every patient.
► Remove the sample line from the water trap.
► Initially leave the water trap fitted to prevent infectious fluid from spurting out. Remove the water trap only after surface disinfection.
► Empty or replace the water trap according to its instructions for use.
Machine reprocessing
Preparation
Disassembling the patient-specific accessories
The following listing has been added:
Required aids:
– Hose for connecting the breathing bag arm
– Hose for connecting the absorber insert
– Flushing adapter for the sensor cap of the O2 sensor
– Cleaning plate for CLIC adapters
Procedure Agent Manufac-turer
Con-centra-tion
Con-tact time
Tem-perature
Neutralizing Neodisher Z Dr. Weigert 0.1 % – –
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Reprocessing
Positioning the components
The following chapter has been corrected:
CLIC adapter (option)
● Lay the CLIC adapter in the basket with the cleaning plate facing downwards.
The following chapter has been added:
Piston diaphragm
● Place the piston diaphragm with the opening facing downwards on an injector nozzle.
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Service
Service
Inspection
Remote service
The following text has been updated:
The device supports the following remote service functions:
– Help Ticket
– Remote Device Check
Further information on the remote service function can be obtained from Dräger.
Technical data
Fresh-gas delivery
The following information has been updated:
Fresh-gas delivery with electronically controlled gas mixer
The following information has been changed:
Gas mixer
O2 flush 25 to 75 L/min at a supply pressure of 2.7 to 6.9 kPa x 100 [bar] (39 to 100 psi; 0.27 to 0.69 MPa)
O2 flow with integrated flowmeter
Range Off; 1 to at least 10 L/min at a supply pressure of 2.7 kPa x 100 [bar] (39 psi or 0.27 MPa)
O2 flow with external flowmeter
Range Off; 1 to at least 10 L/min at a supply pressure of 2.7 kPa x 100 [bar] (39 psi or 0.27 MPa)
Fresh-gas flow FG flow
Information The maximum flow dispensed can be reduced depending on the ambient pressure or temperature. At the limits of the permissible operating conditions, a rate of at least 13.5 L/min is reached. (An STPD flow of 13.5 L/min corre-sponds to an ATPD flow of 22.1 L/min at 620 hPa ambient pressure, for instance.)
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Technical data
Fresh-gas delivery with mechanically controlled gas mixer
Ventilator
The following information has been updated:
Setting range for fresh-gas flow
The following text has been added:
Information The specified setting range can be reduced depending on the ambient pressure or temperature. At the limits of the permissible operating conditions, a rate of at least 10 L/min is reached. (An STPD flow of 10 L/min corresponds to an ATPD flow of 16.3 L/min at 620 hPa ambient pressure, for instance.)
Time-based settings
Pressure rise time Slope (T10...90 time) 0 to 2 seconds;±25 % of the set value or ±200 ms (the larger value applies)
Ratio of inspiratory time to expiratory time I:E
1:50 to 50:1
Inspiration termination criterion Insp term (as a percentage of the maximum inspiratory flow) for pressure supported breaths
5 to 80 %±5 % absolute error
Proportion of plateau time % Tplat to inspiratory time Ti for mandatory breaths in the VC - CMV, VC - SIMV, and VC - SIMV / PS modes
0 to 60 %±10 % absolute error
Volume-based and flow-based set-tings
Inspiratory flow Flow Minimum 0.1 L/min, maximum >120 L/min Results from the following set values:- VT and Ti in volume-controlled ventila-tion modes- Pinsp and Ti in pressure-controlled ventilation modes.Applies for mains operation or in the first 5 minutes of battery operation with a fully charged battery. In other situa-tions, the inspiratory flow may be restricted to 75 L/min.
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Technical data
Measuring systems and displays
The following information has been updated:
Volume
Information The measured volume values displayed already take account of the compliance of the breathing circuit. For devices with the integrated patient-gas measure-ment module (PGM), the sample gas flow of the gas measurement is also taken into consideration as soon as CO2 respiratory phases are detected. For devices without integrated PGM, the specified accuracies apply if the anesthetic gas compensation is cor-rectly set (see the chapter "Anesthetic gas compensation").
Central supply
Range 0 to 9.8 kPa x 100 [bar]0 to 140 psi0 to 0.98 MPa
Accuracy (up to 7 kPa x 100 [bar]) ±4 % or ±0.2 kPa x 100 [bar] (the larger value applies)±4 % or ±3 psi (the larger value applies)±4 % or ±0.02 MPa (the larger value applies)
Resolution of displayed value 0.1 kPa x 100 [bar]1 psi0.01 MPa
Gas cylinders
Range 0 to 250 kPa x 100 [bar]0 to 3600 psi0 to 25 MPa
Accuracy ±4 % or ±6 kPa x 100 [bar] (the larger value applies)±4 % or ±87 psi (the larger value applies)±4 % or ±0.6 MPa (the larger value applies)
Resolution of displayed value 1 kPa x 100 [bar]1 psi0.1 MPa
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Technical data
Gas measurement with O2 sensor
The following information has been updated:
Operating characteristics
The following information has been updated:
Drift Compensated by calibration against ambient air, which is required at the lat-est every 7 days in the context of the system test
O2
Accuracy (according to ISO 80601-2-55) ±(2.5 Vol% + 2.5 % of the measured value) for gas mixtures with anesthetic gas concentrations up to a maximum of 2 Vol% (kPa) of halothane, isoflurane, enflurane, or sevoflurane or up to a maximum of 8 Vol% (kPa) of desflurane
±(7.5 % of the measured value) for gas mixtures with anesthetic gas concentra-tions up to a maximum of 4 Vol% (kPa) of halothane, or up to a maximum of 5 Vol% (kPa) of isoflurane, enflurane, or sevoflurane or up to a maximum of 15 Vol% (kPa) of desflurane
Gas supply
Supply pressure for O2, Air, N2O 2.7 to 6.9 kPa x 100 [bar]39 to 100 psi0.27 to 0.69 MPa
Maximum short-term peak inlet flow at a supply pressure of 6.9 kPa x 100 [bar] (100 psi or 0.69 MPa)
O2 135 L/min (applies only when there is no distribution piece for the central O2 supply)
Air
Without bronchial suction system 50 L/min
Including a directly connected bron-chial suction system
130 L/min
N2O 40 L/min
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Technical data
Pressure reducers (permanently installed)
Permissible inlet pressure (PV)
Air, O2 Up to 200 kPa x 100 [bar] (2900 psi, 20 MPa)
N2O Up to 60 kPa x 100 [bar] (870 psi, 6 MPa)
Noise emissions from device
Sound pressure L(A) of the alarm tones at the user's operating location, measured according to IEC 60601-1-8
Secondary acoustic alarm signal and mains power supply failure alarm
≥50 dB(A) and ≤75 dB(A)
Dimensions of the device, including the breathing system and the ventilator (a tolerance of ±5 mm (0.2 in) applies for all specified dimensions)
Compact version with plug-in connector for 1 vaporizer (may deviate with accessory equipment)
Width 745 mm (29.3 in)
Height 1403 mm (55.2 in)
Depth 692 mm (27.2 in)
Large version with plug-in connectors for 2 vaporizers (may deviate with accessory equipment)
Width 933 mm (36.7 in)
Height 1403 mm (55.2 in)
Depth 724 mm (28.5 in)
Work surface of the compact version
Width 470 mm (18.5 in)
Depth 380 mm (15.0 in)
Work surface of the large version
Width 710 mm (28.0 in)
Depth 380 mm (15.0 in)
Additional pull-out work surface
Width 340 mm (13.4 in)
Depth 245 mm (9.6 in)
Additional folding work surface
Width 300 mm (11.8 in)
Depth 425 mm (16.7 in)
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Technical data
The following information has been updated:
Interfaces and ports
The following information has been updated:
Relevant standards
The following information has been added:
Protection classes
Degree of protection IP11 in compliance with IEC 60529, fulfills ISO 80601-2-13
Serial ports
Information Only connect devices that meet the requirements of IEC 60950-1 / IEC 62368-1 for ungrounded SELV cir-cuits and the requirements of IEC 60601-1 (as of the 2nd edition) for touchable secondary circuits with a maximum nominal voltage of 24 V DC.
Use COM2 to connect devices for external patient-gas measurement with the MEDIBUS communication protocol.
Alarm delay time <3 s for baud rates ≥9600<10 s for baud rates <9600
Network port Only for Dräger Remote ServiceOnly connect devices or networks that meet the requirements of IEC 60950-1 / IEC 62368-1 for ungrounded SELV cir-cuits and the requirements of IEC 60601-1 (as of the 2nd edition) for touchable secondary circuits with a maximum nominal voltage of 24 V DC.
Distribution piece for central O2 supply (optional)
Supply pressure 2.7 to 6.9 kPa x 100 [bar]39 to 100 psi0.27 to 0.69 MPa
ISO 80601-2-13Medical electrical equipment
Part 2-13:Particular requirements for basic safety and essential performance of an anaesthetic workstation
ISO 80601-2-55Medical electrical equipment
Part 2-55:Particular requirements for basic safety and essential performance of respira-tory gas monitors
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Technical data
Diagrams
The following chapter has been updated:
Pressure characteristics and flow characteristics of the breathing system
Breathing system with and without breathing hoses and filters (conforming to ISO 8835-2 and ISO 80601-2-13), fresh-gas flow Air, 10 L/min STPD, inspiratory and expiratory flows STPD:
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Pexp [hPa (cmH2O)] with neonatal breathing hose
Pexp [hPa (cmH2O)] with pediatric breathing hose
Pexp. [hPa (cmH2O)] with adult breathing hose
Pexp. [hPa (cmH2O)] without breathing hoses
Pinsp [hPa (cmH2O)] with neonatal breathing hose
Pinsp [hPa (cmH2O)] with pediatric breathing hose
Pinsp [hPa (cmH2O)] with adult breathing hose
Pinsp [hPa (cmH2O)] without breathing hoses
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Principles of operation
Connections to IT networks
RS-232 ports
The following note has been added:
Note: Every device connected within the distributed alarm system must be labeled with the following precautionary statement: Alarm signal reception is not guaranteed.
Principles of operation
Description of the ventilation modes
PC - SIMV
The following information has been updated:
– Pressure-controlled
– Time-controlled
– Machine-triggered or patient-triggered
– Synchronized inspiration
Breathing system, dry, with filled reusable CO2 absorber and soda lime dust filter MX50115
Peak flow in use [L/min]
Resistance [hPa (cmH2O)]
Man / Spon
Inspiratory Expiratory
Without breathing circuit and inspi-ratory filter
60 –3.7 5.0
30 –1.4 3.1
15 –0.3 2.2
2.5 0.7 1.6
With breathing circuit for adults MP00301, inspiratory filter MP01730
60 –5.9 5.7
30 –2.1 3.3
With breathing circuit for pediatric patients MP00331, filter MP01815 on Y-piece
15 –2.0 3.8
With breathing circuit for neonates MP00333, filter MP01815 on Y-piece
2.5 0.4 1.9
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Annex
Annex
Product labels
The following product labels have been added or updated:
Product label Explanation
If a non-rebreathing system is con-nected, make sure that the operation mode Ext. FGO is used. For more infor-mation, see "Special forms of therapy" in the chapter "Operation".
Observe the weight of the nominal con-figuration and the permissible total weight (see the chapter "Technical data").
Transport information (see "Intrahospi-tal transport")
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Annex
Symbols
The following symbols have been changed:
Symbol Explanation
Label: Do not place or attach any weights here.
Main switch on
Main switch off
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Á9056596ßÈ
Manufacturer
Drägerwerk AG & Co. KGaAMoislinger Allee 53-5523542 LübeckGermany+49 451 8 82-0
FAX +49 451 8 82-2080http://www.draeger.com
9056596 – en© Drägerwerk AG & Co. KGaAEdition: 2 – 2019-04(Edition: 1 – 2019-01) Dräger reserves the right to make modifications to the medical device without prior notice.