Atlan A300 series Instructions for Use sw 1.0n Edition 2 April 2019

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Instructions for use

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

Contents

Contents 1

2

3

4

5

6

Information about this document ...

7

1.1 1.2 1.3 1.4

Typographical conventions ... Use of terms ... Illustrations... Trademarks...

7 7 7 7

Safety-related information...

9

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9

Intended use ... Indications... Contraindications ... Environments of use ... Essential performance features ... User group requirements ... Information on safety instructions and precautionary statements... Safety instructions ... Additional information ...

9 9 9 10 10 11 11 12 14

Overview ...

15

3.1 3.2 3.3

Hardware ... Functional scope... Gas flow diagram...

15 31 42

Assembly and preparation ... 4.1 Safety instructions ... 4.2 Mounting of accessories ... 4.3 Before first operation ... 4.4 Intrahospital transport ... 4.5 Gas supply... 4.6 Connecting to the gas scavenging system ... 4.7 Preparation for an operation day / after cleaning and sterilization.. 4.8 Selecting and connecting patient-specific accessories... 4.9 Connecting and replacing consumables...

45

Operating concept...

79

5.1 5.2 5.3

Screen ... Color concept... Selecting and setting ...

79 83 84

Getting started...

86

6.1 6.2 6.3 6.4 6.5

86 86 86 87 88

Safety instructions ... Turning on the device ... Checking the device configuration... Checking the operational readiness ... Emergency start-up ...

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

45 52 55 59 59 65 67 67 75

3

Contents

7

8

9

Operation ...

89

7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 7.13 7.14

Safety instructions ... Starting the therapy ... Adjusting the therapy ... Special forms of therapy ... Using fields with special functions ... Customizing the screen display ... Displaying additional data... Setting the volume ... Adjusting the alarms ... Changing the patient data... Exporting data... Other settings ... Ending the therapy... Change of patient ...

89 93 96 100 103 107 113 115 116 119 119 120 122 124

Tests ...

126

8.1 8.2 8.3 8.4

Status of the device functions... Available test types... Performing the tests... Checklist in the walk-through mode...

126 127 127 136

Ending operation...

151

At the end of the OR day ... Storing the device ... Disconnecting the mains power supply ...

151 151 151

9.1 9.2 9.3

10 Alarms ... 10.1 10.2 10.3 10.4 10.5 10.6 10.7

Safety instructions ... Displaying alarms ... Response to alarms... Adopting alarm settings when changing the ventilation mode... Alarm delay and alarm escalation... Activation of alarms after breath detection ... Intelligent alarm behavior...

11 Configuration...

165

11.1 11.2 11.3 11.4 11.5 11.6

Device settings ... Setting the date and time... Specifying the start settings... Transferring device configurations... Activating software options ... Overview of configurable screen contents...

165 165 166 181 182 184

12 Troubleshooting ...

190

12.1 12.2 12.3 12.4 12.5

4

152 152 152 154 159 160 163 164

Leakage ... Power supply failure ... Failure of the gas supply... Failure of fresh-gas delivery (electronically controlled gas mixture) Failure of the piston ventilator...

190 191 192 194 195

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

Contents

12.6 Failure of the O2 sensor... 12.7 Flow measurement failure ... 12.8 Screen fault or failure of the graphical user interface ... 12.9 Complete failure... 12.10 Problems with the active anesthetic gas receiving system (AGS) .. 12.11 Cylinder pressure reducer ... 12.12 Support request ... 12.13 Alarm – Cause – Remedy...

195 198 198 198 199 201 201 201

13 Reprocessing...

222

13.1 Safety instructions ... 13.2 Information on reprocessing ... 13.3 Classifications for reprocessing ... 13.4 Reprocessing list ... 13.5 Reprocessing procedures... 13.6 Preparation ... 13.7 Surface disinfection with cleaning... 13.8 Disassembly ... 13.9 Disassembling the breathing system ... 13.10 Machine reprocessing... 13.11 Fitting and assembly... 13.12 Preparation before the next use ... 13.13 Brief instructions for reprocessing ...

222 223 224 225 225 227 229 230 238 242 249 258 260

14 Service ...

262

14.1 14.2 14.3 14.4 14.5

Safety instructions ... Definition of service terminology... Inspection ... Maintenance ... Repair ...

262 262 262 265 265

15 Disposal ...

266

15.1 15.2 15.3

Safety instructions ... Disposing of the device... Disposing of accessories ...

266 266 266

16 Technical data ...

267

16.1 Safety instructions ... 16.2 General information ... 16.3 Ambient conditions ... 16.4 Fresh-gas delivery ... 16.5 Fresh-gas delivery with electronically controlled gas mixer ... 16.6 Fresh-gas delivery with mechanically controlled gas mixer ... 16.7 Ventilator... 16.8 Breathing system ... 16.9 External fresh-gas outlet... 16.10 Anesthetic gas receiving system (AGS) ... 16.11 Active AGS ... 16.12 Passive AGS... 16.13 Measuring systems and displays... 16.14 Gas measurement ...

267 268 268 269 269 270 270 272 274 274 274 275 275 279

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

5

Contents

16.15 Gas measurement with PGM... 16.16 Gas measurement with O2 sensor... 16.17 Display of calculated values ... 16.18 Operating characteristics ... 16.19 Interfaces and ports ... 16.20 Relevant standards... 16.21 Diagrams ... 16.22 EMC declaration ... 16.23 Device combinations... 16.24 Emission of high-frequency energy ... 16.25 Connections to IT networks ... 16.26 Open-source software ...

279 281 282 283 287 289 290 291 293 293 294 297

17 Principles of operation ...

297

17.1 17.2 17.3 17.4 17.5 17.6 17.7 17.8

Safety instructions ... Description of the ventilation modes... Description of the ventilation drive... Improving the CO2 measurement by means of an HME filter... Minimum O2 delivery ... Influence of patient category, weight, and age on device behavior Support of Infinity ID accessories ... Schematic illustration of the acoustic signals ...

297 298 307 308 310 311 312 313

18 Annex ...

314

18.1 18.2 18.3 18.4

Abbreviations ... Symbols ... Product labels ... Overview of the menu structure...

314 317 322 323

19 Password ...

325

19.1

6

Configuration password for Atlan A300, A300 XL, A350, A350 XL Software 1.0n ...

325

Index ...

327

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

Information about this document

1

Information about this document

1.1

Typographical conventions Text

Bold, italicized text indicates labels on the device and screen text.

1.

Numbers with a period indicate the individual steps within a process sequence. The numbering for each new process sequence starts once more at number 1.

a.

Lower-case letters with a period indicate secondary process steps. The lettering for each new higher-level process step starts once more with the letter a.

►

This triangle indicates individual steps without any specific order.

(1)

Numbers in parentheses refer to elements in illustrations.

1

Numbers in illustrations denote elements referred to in the text.

–

Dashes indicate listings.

>

The greater-than symbol indicates the navigation path in a dialog. This symbol indicates information that will facilitate the use of the product.

1.2

Use of terms Dräger uses the term "accessories" not only for accessories in the sense of IEC 60601-1, but also for consumables, removable parts, and attached parts. The product "Atlan A300, A300 XL, A350, A350 XL" is also referred to as "Atlan".

1.3

Illustrations Illustrations of products and screen content in this document may differ from the actual products depending on configuration and design.

1.4

Trademarks

1.4.1

Trademarks owned by Dräger Trademark Atlan® AutoFlow® Infinity® D-Vapor® Drägersorb® MEDIBUS® ServiceConnect® WaterLock®

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

7

Information about this document

Trademark E-Vent® The following web page provides a list of the countries in which the trademarks are registered: www.draeger.com/trademarks

1.4.2

Trademarks owned by third-party manufacturers Trademark ®

Selectatec

Trademark owner Datex-Ohmeda

Dismozon® Mikrobac®

BODE Chemie

Korsolex® Neodisher Mediclean®

Dr. Weigert

acryl-des® Mikrozid®

Schülke & Mayr

Perform® Actichlor® OxyCide®

Ecolab USA

BruTab 6S®

Brulin

Dispatch®

Clorox

Klorsept®

Medentech

Descogen® Oxygenon®

Antiseptica

Virkon®

DuPont

SteriMax®

Aseptix

Cleanisept®

Dr. Schumacher

Trademark used Trademark owner under license BIPAP

8

Respironics

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

Safety-related information

2

Safety-related information

2.1

Intended use This device is intended for use in anesthetizing adults, pediatric patients, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is equipped with the following basic functions: – Ventilation monitoring – Inspiratory O2 measurement – Device monitoring – Anesthetic gas receiving system The following options are additionally available: – Patient-gas measurement module for O2, CO2, N2O, and anesthetic gases – O2 insufflation Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents. Ventilation is accomplished on the patient through a laryngeal mask, a breathing mask, or an endotracheal tube. The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow). A non-rebreathing system, such as the Bain, Mapleson, Kuhn, or Waters system, may be used at the external fresh-gas outlet.

2.2

Indications The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.

2.3

Contraindications The device has no product-specific contraindications. It is the responsibility of the user to select the appropriate treatment for the patient’s underlying disease. The patient's condition must be continually monitored for any potential changes. The safety information must be followed for patients suspected of malignant hyperthermia, patients with ketoacidosis, and patients who are under the influence of alcohol. Observe the following information: "Therapy and applications", page 89. The device administers medical gases such as O2, N2O, Air (medical compressed air), and volatile anesthetic agents (halothane, enflurane, isoflurane, sevoflurane, desflurane). For contraindications to the applied medical gases, strictly follow the instructions for use of the medical gases.

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

9

Safety-related information

2.4

Environments of use The device is designed for use in rooms in which therapeutic or diagnostic interventions can be performed under constant supervision of users. According to IEC 60601-1-2, the use of the device is only permissible in hospitals and comparable facilities with a Class A electromagnetic environment. Do not use the device in the following environments: – Outside buildings – On intensive care units – During patient transport – In vehicles, airplanes, helicopters, and on ships – In areas where oxygen concentrations above 25 Vol% or combustible or explosive gas mixtures can occur. – In rooms with magnetic field applications (e.g., magnetic resonance imaging)

2.5

Essential performance features Correct functioning of the essential performance features ensures that the product can be used in accordance with its intended use. The product has the following essential performance features: General – Supply of the anesthesia workstation with O2: If the O2 supply (central gas supply or gas cylinder) fails, an alarm is issued. – Supply of the patient with adequately oxygenated breathing gas: If the breathing gas contains insufficient levels of O2, an alarm is issued. – Supply of an adequate anesthetic gas concentration to the patient: When the anesthetic gas is measured by means of an integrated patient-gas measurement module, an alarm will be generated if the anesthetic gas concentrations are too high. – Monitoring of the airway pressure: Alarms are issued depending on the set alarm limits. Gas measurement – Breathing gas monitoring: – Set values for FiO2 – Inspiratory and expiratory measured values for O2, CO2, N2O, and anesthetic gas; automatic anesthetic agent identification (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.

10

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

Safety-related information

2.6

User group requirements The term "user group" describes the responsible personnel who have been assigned by the operating organization to perform specific tasks on the product.

2.6.1

Duties of the operating organization The operating organization must ensure the following: – Each user group has the required qualification (e.g., has undergone specialist training or acquired specialist knowledge through experience). – Each user group has been trained to perform the task. – Each user group has read and understood the relevant chapters in this document.

2.6.2

User groups Clinical users This user group uses the product in accordance with the intended use. Reprocessing personnel This user group performs reprocessing activities. Service personnel This user group installs the product and performs service activities. If product-specific skills or tools are required, then the service activities must be performed by specialized service personnel. The specialized service personnel have been trained by Dräger to perform these specific service activities on this specific product.

2.7

Information on safety instructions and precautionary statements Safety instructions and precautionary statements warn of risks and give instructions for the safe use of the product. Failure to observe them may lead to personal injury or property damage.

2.7.1

Safety instructions This document contains sections with safety instructions which warn of risks. The type of risk and the consequences of non-compliance are described in each safety instruction.

2.7.2

Precautionary statements Precautionary statements relate to action steps and warn of risks that may arise when performing the action steps. Precautionary statements precede the action steps.

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

11

Safety-related information

The following warning signs and signal words indicate precautionary statements and differentiate the possible consequences of non-compliance. Warning sign Signal word WARNING

Consequences of non-compliance May result in death or serious injury.

CAUTION

May result in moderate or minor injury.

NOTICE

May result in property damage.

2.8

Safety instructions

2.8.1

Instructions for use Personal injury and property damage may arise if this product is used contrary to the information in these instructions for use. ► Follow these instructions for use. ► Only use this product in accordance with its intended use. ► Keep these instructions for use in an accessible location. Make sure that the instructions for use are compatible with the device software. ► Follow the instructions for use of all the products that are used with this product. These instructions for use do not provide any information on the following: – Risks that are obvious to the user – Consequences of foreseeable misuse of the product – Possible negative effects on patients with one or more diseases

2.8.2

Symbols and product labels Failure to observe symbols and product labels may result in personal injury and property damage. ► Observe the symbols and product labels.

2.8.3

Monitoring the patient's condition The monitoring of the patient's condition can range from direct observation to electronic monitoring by means of medical devices. If the patient's condition is not adequately monitored, the patient may be put at risk. ► Monitor the patient's condition in an appropriate manner and at appropriate intervals. N2O, O2, CO2 and, where necessary, anesthetic gases must be monitored when patients are ventilated. If no monitoring is available or the sensors are not ready for operation, the patient will not be adequately monitored and may be put at risk. ► Provide for suitable monitoring of O2, CO2, N2O, and anesthetic gases in accordance with ISO 80601-2-55. ► Provide for suitable substitute monitoring in the event of a fault.

12

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

Safety-related information

2.8.4

Accessories and components Compatible accessories The use of faulty or incompatible accessories may compromise the functional integrity of the product. Personal injury and property damage may occur as a consequence. ► Use only compatible accessories. The accessories that are compatible with this product are listed in the list of accessories supplied with the product. ► Use only accessories that are in good working order. Instructions for use for accessories If accessories or connected devices are used contrary to the information in the associated instructions for use, this may lead to user errors, incorrect use, or incorrect reprocessing. Personal injury and property damage may occur as a consequence. ► Follow the instructions for use for all accessories, e.g.: – Water traps – Flow sensors – CLIC adapter – CLIC absorber – Soda lime – Breathing hoses – Masks – Filter – Bronchial suction – Vaporizer – Manual resuscitator – AGSS terminal unit

2.8.5

Color codes and labels In some countries, the arrangement and display of the gases on the status display and the virtual flow tubes on the screen may deviate from the illustrations shown in this document. ► Always pay attention to the respective color codes and labels.

2.8.6

Device Penetrating liquid Penetrating liquid may cause the following: – Damage to the device – Electric shock – Device malfunctions Personal injury and property damage may occur as a consequence. ► Ensure that no liquid penetrates the device. ► Do not place any containers containing liquids above or on the device.

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

13

Safety-related information

Housing Under the housing, there are live electrical components, which may cause an electric shock. ► The housing may only be opened by those user groups that are assigned to that particular measure.

2.8.7

Service If service activities are not performed regularly or properly, malfunctions may occur that can result in personal injury and property damage. ► Perform the service in accordance with the chapter "Service".

2.8.8

Reprocessing Reusable products must be reprocessed, otherwise there is an increased risk of infection. ► Perform the reprocessing in accordance with the chapter "Reprocessing".

2.8.9

Modifications to the product Modifications to the product may lead to malfunctions and unforeseen risks. This may result in injury to the patient or the user or in property damage. ► Do not modify this product.

2.8.10

Network security The impermissible use of data interfaces may result in property damage and personal injury. ► Only make connections to data interfaces with permission from the responsible organization (IT representative and the hospital equipment officer). ► Observe the following information: "Connections to IT networks", page 294.

2.9

Additional information

2.9.1

Use of Infinity ID components Ownership or purchase of this medical device with RFID technology only includes the right to use the medical device and RFID technology in conjunction with products approved by Dräger and in strict compliance with these instructions for use. No intellectual property rights or any rights to the use of the medical device or RFID technology are hereby granted, either explicitly or implicitly, which are contrary to the above-mentioned conditions.

2.9.2

Training Training for users is available via the Dräger organization responsible (see www.draeger.com).

14

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

Overview

Overview

3.1

Hardware

3.1.1

Front

3.1.1.1

Large version 36437

3

No. 1 2 3 4 5 6 7 8 9 10

Designation Screen

Description Enables user inputs by touchscreen and rotary knob. Plug-in connectors for vaporiz- Enable the connection of up to 3 vaporizers. ers Backup manual switch (behind Used to switch to backup manual mode in the flap) the event of malfunctions of the device. Gas mixing unit Produces a gas mixture from the selected gases (e.g., O2 and Air). Work surface Used for storing, e.g., documents. Pull-out writing tray (option) Provides additional work surface. Viewing window for piston ven- Allows visual checking of the movement of tilator the piston ventilator. Lockable drawer Provides additional storage space. Trolley with footrest and cen- Used for moving the device. The central tral brake brake locks the two front castors. CO2 absorber Absorbs CO2 from the patient’s breathing gas.

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

15

Overview

No. 11

12

13 14

Description Used for suctioning and scavenging excess anesthetic gas and breathing gas. Used to reduce the anesthetic gas concentration released into the environment by the anesthesia machine, and to scavenge the sample gases from an anesthetic gas monitor. External fresh-gas outlet Gas outlet for a mixture of fresh gas and anesthetic gas which is fed to a nonrebreathing system. External O2 flowmeter (option) Supplies pure oxygen for O2 insufflation. Rail Used for fastening additional components.

Compact version 36438

3.1.1.2

Designation Anesthetic gas receiving system

No. 1 2 3 4 5 6 7 8 9

16

Designation Screen

Description Enables user inputs by touchscreen and rotary knob. Plug-in connectors for vaporiz- Enable the connection of up to 2 vaporizers. ers Backup manual switch (behind Used to switch to backup manual mode in the flap) the event of malfunctions of the device. Swiveling shelf (option) Used for storage. Work surface Used for storing, e.g., documents. Viewing window for piston ven- Allows visual checking of the movement of tilator the piston ventilator. Lockable drawer Provides additional storage space. Trolley with footrest and cen- Used for moving the device. The central tral brake brake locks the two front castors. CO2 absorber Absorbs CO2 from the patient’s breathing gas.

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

Overview

Designation Anesthetic gas receiving system

11

Gas mixing unit

12

External fresh-gas outlet

13

Rail

Description Used for suctioning and scavenging excess anesthetic gas and breathing gas. Used to reduce the anesthetic gas concentration released into the environment by the anesthesia machine, and to scavenge the sample gases from an anesthetic gas monitor. Produces a gas mixture from the selected gases (e.g., O2 and Air). Gas outlet for a mixture of fresh gas and anesthetic gas which is fed to a nonrebreathing system. Used for fastening additional components.

Screen 36441

3.1.2

No. 10

No. 1 2

Designation Touchscreen Alarm silence key

3

Rotary knob

4 5

Working light

6

key

key

Description Calls up functions or dialogs when touched. Suppresses the alarm tones of all active alarms for 2 minutes. Used for selecting, adjusting, and confirming settings. Lights up in color in certain situations. Illuminates the work surface. Turns the working light on or off. Dims the illuminance in 3 steps (dark, medium, and bright). Turns the device on or off.

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

17

Overview

3.1.3

Breathing system and other components

3.1.3.1

Overview

36446

The following illustration shows the device and the breathing system.

18

No. 1

Designation Pressure gauge (option)

2

Inspiratory port

3

Bag elbow with circuit plug

4

APL valve

5

Breathing system cover

6

Expiratory port

7 8

Holder Handles

9

CO2 absorber

10

Anesthetic gas receiving system

Description Indicates the airway pressure in the internal breathing system. Used to connect the inspiratory hose to the device. Used to connect the breathing bag hose. The circuit plug is used to seal the Y-piece during an automatic test. Limits the maximum airway pressure in the Manual / Spontaneous mode. Protects the breathing system underneath and provides climate control for the breathing system. Used to connect the expiratory hose to the device. Used for parking the breathing bag hose. Used for aligning the device and for stowing used breathing hoses. Absorbs CO2 from the patient’s breathing gas. Used for suctioning and scavenging excess anesthetic gas and breathing gas, to reduce the anesthetic gas concentration released into the environment by the anesthesia machine, and to scavenge the sample gases from an anesthetic gas monitor.

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

Overview

No. 11 12

13

3.1.3.2

Designation Water trap with connection for sample line Patient-gas measurement module Guide clip

Description Collects condensed water which forms in the sample line. Measures and monitors various gas concentrations in the breathing gas (O2, CO2, N2O, and anesthetic gases). Used to securely lay the O2 insufflation hose.

Version with O2 sensor

36447

The following illustration shows the device without its breathing system cover and illustrates the position of the O2 sensor.

No. 1

Designation O2 sensor

2

Sealing cap

Description Measures the inspiratory O2 concentration in the breathing gas. Seals the O2 sensor port during calibration of the O2 sensor.

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n

19

Overview

Side view from left 36462

3.1.4

No. 1 2 3 4

20

Designation Castor brake Gas cylinder holder (option) Rail Hanger yoke system (option)

Description Prevents movement of the rear castor. Secures the gas cylinders. Used for fastening additional components. Enables the connection of gas cylinders with a pin-index connector.

Instructions for use | Atlan A300, A300 XL, A350, A350 XL SW 1.0n