Supplement Atlan A300, A300 XL, A350, A350 XL … · Supplement | Atlan A300, A300 XL, A350, A350...

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

2 Supplement | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

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Supplement | Atlan A300, A300 XL, A350, A350 XL SW 1.0n 3

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


Assembly and preparation

Overview

The following table has been changed:


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



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.



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


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.


Ending operation

Ending operation

Storing the device


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


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.


Reprocessing

Reprocessing

Reprocessing procedures

Validated reprocessing procedures


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 % – –


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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02


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.)


Technical data

Fresh-gas delivery with mechanically controlled gas mixer

Ventilator


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.


Technical data

Measuring systems and displays


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


Technical data

Gas measurement with O2 sensor


Operating characteristics


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


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)


Height 1403 mm (55.2 in)


Work surface of the compact version



Work surface of the large version



Additional pull-out work surface



Additional folding work surface




Technical data


Interfaces and ports


Relevant standards


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


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


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


– 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


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")


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





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.

Date post:	20-Sep-2020
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