Atlan

K230931 · Drägerwerk AG Co. Kgaa · BSZ · Jul 23, 2023 · Anesthesiology

Device Facts

• Record ID: K230931
• Device Name: Atlan
• Applicant: Drägerwerk AG Co. Kgaa
• Product Code: BSZ · Anesthesiology
• Decision Date: Jul 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 02 measurement - Device monitoring - Anesthetic gas receiving system The following options are additionally available: - Patient-gas measurement module for 02, CO2, N2O, and anesthetic gases - 02 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).

Device Story

Atlan anesthesia workstation; delivers volatile anesthetic agents and provides patient ventilation. Inputs: medical gases (O2, Air, N2O) from central supply or cylinders. Operation: electronically or mechanically controlled gas mixer creates gas mixture; anesthetic breathing system delivers gas to patient via laryngeal mask, breathing mask, or endotracheal tube; piston-driven ventilator supports controlled/assisted ventilation; integrated scavenger removes waste gases. Used in OR/clinical settings by clinicians. Features: gas/ventilation monitoring, RFID for accessory compatibility (water traps, flow sensors, absorbers), and system self-tests. Output: real-time waveforms, numeric parameters, and trends on 15" touchscreen. Clinicians use data to adjust ventilation/anesthesia delivery. Benefits: precise gas delivery, patient safety via integrated monitoring/alarms, and support for low/minimum-flow anesthesia.

Clinical Evidence

Bench testing only. Verification and validation activities included electrical safety, EMC, biocompatibility, software/cybersecurity, alarm system performance (IEC 60601-1-8), anesthetic workstation requirements (ISO 80601-2-13), respiratory gas monitoring (ISO 80601-2-55), and usability engineering (IEC 60601-1-6, IEC 62366-1). Waveform performance compared to predicate per ASTM-F1101.

Technological Characteristics

Anesthesia workstation; piston-driven ventilator; electronically or mechanically controlled gas mixer. Features 15" TFT LCD touchscreen, rotary knob, and RFID for accessory identification. Gas monitoring via side-stream paramagnetic (O2) and infrared spectrometry (CO2, N2O, anesthetic agents). Connectivity includes RFID for Infinity ID accessories. Complies with AAMI ANSI ES60601-1, ISO 80601-2-13, ISO 80601-2-55, and IEC 62304.

Indications for Use

Indicated for inhalational anesthesia and/or patient ventilation during surgical or diagnostic interventions in adults, pediatric patients, and neonates.

Regulatory Classification

Identification

A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).

Predicate Devices

• Perseus A500 (K133886)

Reference Devices

• Dräger Primus US Apollo (K042607)
• Maquet Flow-I (K191027)
• GE Aisys CS2 (K170872)
• Dräger Fabius CS/Fabius Tiro (K042419)
• Fabius (K011404)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 23, 2023

Drägerwerk AG Co. KGaA Marianne Selent Regulatory Affairs Manager Moislinger Allee 53-55 Lübeck, Schleswig-Holstein 23542 Germany

Re: K230931

Trade/Device Name: Atlan Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine For Anesthesia Or Analgesia Regulatory Class: Class II Product Code: BSZ Dated: June 23, 2023 Received: June 23, 2023

#### Dear Marianne Selent:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# James J. Lee -S

James J. Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K230931

Device Name Atlan

#### Indications for Use (Describe)

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 02 measurement
- Device monitoring
- Anesthetic gas receiving system

The following options are additionally available:

- Patient-gas measurement module for 02, CO2, N2O, and anesthetic gases
- 02 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).

Indications

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

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Premarket Notification Summary

| Submitter: | Drägerwerk AG & Co. KGaA<br>Moislinger Allee 53-55<br>23542 Lübeck, Germany<br>Establishment's registration number: 9611500 | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Official correspondent: | Dr. Marianne Selent<br>Regulatory Affairs Manager<br>E-Mail: [e-mail]<br>Telephone: [phone] | |
| US agent: | Darlene Thibodeau<br>Head of Quality Assurance and Compliance<br>E-mail: [e-mail]<br>Telephone: [phone] | |
| Date prepared: | July 18, 2023 | |
| Device Name: | Trade name:<br>Common name:<br>Classification name:<br>Regulation number:<br>Product code:<br>Class: | Atlan<br>Anesthesia machine<br>Gas-machine, anesthesia<br>21 CFR §868.5160<br>BSZ<br>II |
| Predicate Device: | Perseus A500, K133886 | |
| Reference Devices: | Dräger Primus US Apollo, K042607<br>Maquet Flow-I, K191027<br>GE Aisys CS2, K170872<br>Dräger Fabius CS/Fabius Tiro, K042419 | |

Drägerwerk AG & Co. KGaA is submitting a traditional 510(k) premarket notification for a new device, the Atlan anesthesia workstation.

### Device Description

The Atlan anesthesia workstation was developed and is manufactured by Dräger in Lübeck, Germany. The anesthesia workstation is specified for inhalational anesthesia using volatile

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anesthetic agents and/or patient ventilation, including the delivery of oxygen and the monitoring of device functions as well as the patient's and/or anesthetic parameters. Atlan is available in different device variants and can be upgraded by software and hardware options as well as attachable accessories.

The Atlan anesthesia workstation consists of four major subsystems, each of which operates on its own specific principle while interacting with the other subsystems to achieve the intended use. These major subsystems include:

- Gas reception and delivery, i.e., gas mixer o
- o Anesthetic breathing system
- o Anesthetic ventilator
- o Anesthetic gas scavenger

The Atlan anesthesia workstation receives medical gases from a cylinder or central gas supply, creates a gas mixture, or composition, and delivers this mixture at a determined flow rate to the anesthetic breathing system.

Atlan's anesthetic breathing system is the interface between the anesthesia workstation and the patient. Its purpose is to deliver the gas composition to the patient. While doing so, the anesthetic breathing system converts the continuous gas flow to the patient's intermittent respiratory flow, supports controlled or assisted ventilation, and allows for gas sampling and pressure measurements. Furthermore, the anesthetic breathing system conditions the inspiratory gas by means of a heater and removes carbon dioxides from the patient's expired qas.

The anesthetic ventilator drives fresh gas from the anesthetic breathing system to the patient and expired gas to the anesthetic gas scavenger.

Atlan's integrated anesthetic gas scavenger collects all waste anesthetic gases received from the breathing circuit and passes it on to a hospital disposal system.

The anesthesia workstation is also comprised of several minor subsystems whose interactions with the main subsystems help to address considerations of patient safety and system integrity. The minor subsystems include:

- o Gas monitoring
- o Ventilation and airway monitoring
- Device monitoring, including system self test o
- Embedded control display o
- RFID capabilities o

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#### Indications for Use

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 02, CO2, N2O, and anesthetic gases
- 02 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).

#### Indications

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

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#### List of Consensus Standards

| Standard Number and Version | Title |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI ANSI ES60601-1:2005/(R)2012<br>and A1:2012, C1:2009/(R)2012 and<br>A2:2010/(R)2012 | Medical electrical equipment - Part 1: General requirements<br>for basic safety and essential performance |
| ANSI AAMI IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests |
| AIM 7351731 Rev. 2.00 2017-02-23 | Medical Electrical Equipment and System Electromagnetic<br>Immunity Test for Exposure to Radio Frequency<br>Identification Readers - An AIM Standard |
| IEC 60601-1-6 Edition 3.1 2013-10 | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential performance -<br>Collateral standard: Usability |
| ANSI AAMI IEC 60601-1-8:2012 | Medical electrical equipment - Part 1-8: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: General requirements, tests and<br>guidance for alarm systems in medical electrical equipment<br>and medical electrical systems |
| ISO 80601-2-13:2011 AMD 1 2015 AMD<br>2 2018 | Medical electrical equipment -- Part 2-13: Particular<br>requirements for basic safety and essential performance of<br>an anaesthetic workstation |
| ISO 80601-2-55:2018 | Medical electrical equipment - Part 2-55: Particular<br>requirements for the basic safety and essential performance<br>of respiratory gas monitors |
| ISO 14971:2019-12 | Medical devices - Application of risk management to<br>medical devices |
| IEC 62366-1 Edition 1.0 2015-02<br>Including Corrigendum 1 (2016)] | Medical devices - Part 1: Application of usability engineering<br>to medical devices |
| ANSI AAMI IEC 62304 Edition 1.1 2015-<br>06 | Medical device software - Software life cycle processes |
| ANSI AAMI ISO 10993-1: 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation<br>and testing within a risk management process |
| ISO 18562-1:2017-03 | Biocompatibility evaluation of breathing gas pathways in<br>healthcare applications - Part 1: Evaluation and testing<br>within a risk management process |
| ANSI AAMI ISO 17664:2017 | Processing of health care products - Information to be<br>provided by the medical device manufacturer for the<br>processing of medical devices |
| IEC/TR 60601-4-2 Edition 1.0 2016-05 | Medical electrical equipment - Part 4-2: Guidance and<br>interpretation - Electromagnetic immunity: performance of<br>medical electrical equipment and medical electrical systems |

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### Comparison to Predicate and Reference Devices

| Specification | Subject Device<br>Atlan | Predicate Device<br>Perseus A500 | Reference Device(s) |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Drägerwerk AG & Co. KGaA | Drägerwerk AG & Co. KGaA | - |
| 510(k) Number | - | K133886 | - |
| Regulation Number | 868.5160 | 868.5160 | - |
| Product Code | BSZ | BSZ | - |
| Classification name | Gas-machine - Anesthesia | Gas-machine - Anesthesia | - |
| Regulatory Class | 2 | 2 | - |
| Indications for Use | The device is specified for inhalational anesthesia<br>and/or patient ventilation in accordance with the<br>intended use during surgical or diagnostic inter-<br>ventions. | Perseus is specified for inhalational anesthesia and/or<br>patient ventilation in accordance with the intended use<br>during surgical or diagnostic interventions. | - |
| Target Population /<br>Patient Population | This device is intended for use in anesthetizing adults,<br>pediatric patients, and neonates. | The Perseus anesthesia workstation is intended for<br>use in anesthetizing adults, children, and neonates. | - |
| Technological Characteristics | | | |
| Gas reception,<br>supplies | Via:<br>• Central gas supply<br>• Reserve gas cylinder | Via:<br>• Central gas supply<br>• Reserve gas cylinder | - |
| Gas reception,<br>reserve gas cylinder | • Basic cylinder support (cylinders closed if central<br>supply available to prevent unintentional emptying<br>if the central supply fails or falls below the<br>specified level; the backup cylinders must be<br>opened manually) or<br>• Advanced cylinder support (cylinders open even if<br>central supply available; if the central supply fails,<br>cylinder supply automatically used) | • Basic cylinder support (cylinders closed if central<br>supply available to prevent unintentional emptying<br>if the central supply fails or falls below the<br>specified level; the backup cylinders must be<br>opened manually) or<br>• Advanced cylinder support (cylinders open even if<br>central supply available; if the central supply fails,<br>cylinder supply automatically used) | - |
| Specification | Subject Device<br>Atlan | Predicate Device<br>Perseus A500 | Reference Device(s) |
| Gas delivery,<br>gases/gas<br>composition | Electronically controlled mixer<br>• Air/O2<br>• O2/N2O (optional)<br>• O2 flush (button on mixer front)<br>Mechanically controlled mixer<br>• Air/O2/N2O (N2O optional)<br>• O2 flush (button on mixer front) | Electronically controlled mixer<br>• Air/O2<br>• O2/N2O (optional)<br>• O2 flush (button on mixer front)<br>Mechanically controlled mixer<br>• Air/O2/N2O (N2O optional)<br>• O2 flush (button on mixer front) | - |
| Gas delivery, Safety<br>Oxygen Ratio<br>Controller (SORC) | Yes<br>Electronically controlled gas mixer:<br>O2 to N2O ≥25%<br>Mechanically controlled gas mixer:<br>O2 to N2O ≥21% | Yes<br>Electronically controlled gas mixer:<br>O2 to N2O ≥25%<br>Mechanically controlled gas mixer:<br>O2 to N2O ≥21% | - |
| Gas delivery, control | Electronically or manually | Electronically or manually | - |
| Gas delivery, auxiliary<br>oxygen | Optionally in one of three ways:<br>• integrated in the gas mixer front for both<br>electronically and mechanically controlled gas<br>mixer variants<br>• externally mounted as a flowmeter for the<br>mechanically controlled gas mixer variant only<br>• not included at all, but only if the mechanically<br>controlled gas mixer is configured | • integrated in the gas mixer front for both<br>electronically and mechanically controlled gas<br>mixer variants | - |
| Anesthetic breathing<br>system | Integrated, supports partial rebreathing<br>• low-flow anesthesia<br>• minimum-flow anesthesia | Integrated, supports partial rebreathing<br>• low-flow anesthesia<br>• minimum-flow anesthesia | - |
| Anesthetic ventilator,<br>drive type | Piston | Blower | Primus US Apollo (K042607):<br>Piston |
| Specification | Subject Device<br>Atlan | Predicate Device<br>Perseus A500 | Reference Device(s) |
| Anesthetic ventilator,<br>basic ventilation types | • Spontaneous breathing<br>• Manual ventilation<br>• Automatic (or controlled) ventilation<br><span style="padding-left: 20px;">○ Pressure-controlled</span><br><span style="padding-left: 20px;">○ Volume/flow-controlled</span> | • Spontaneous breathing<br>• Manual ventilation<br>• Automatic (or controlled) ventilation<br><span style="padding-left: 20px;">○ Pressure-controlled</span><br><span style="padding-left: 20px;">○ Volume/flow-controlled</span> | - |
| Anesthetic ventilator,<br>features | • Compliance compensation<br>• Fresh-gas decoupling | • Compliance compensation<br>• Fresh-gas decoupling | - |
| Anesthetic ventilator,<br>ventilation modes,<br>applicable to all<br>patient populations | Manual / Spontaneous<br>Man/Spon | Manual / Spontaneous<br>Man/Spon | - |
| | - | Manual / Spontaneous with CPAP, optional when PS option enabled | - |
| | Continuous positive airway pressure / Pressure-controlled ventilation,<br>CPAP / PSV | CPAP / Pressure Support | - |
| | Pressure-controlled ventilation – Controlled mandatory ventilation,<br>PC – CMV | Pressure Control - CMV | - |
| | Pressure-controlled ventilation – Synchronized intermitted mandatory ventilation,<br>PC – SIMV | Pressure Control - SIMV+ | - |
| | Pressure-controlled ventilation – Synchronized intermitted mandatory ventilation – Pressure support,<br>PC – SIMV/PS | Pressure Control - SIMV+ / PS | - |
| | Volume-controlled ventilation – Controlled mandatory ventilation / AutoFlow,<br>VC – CMV/AutoFlow | Volume Control - CMV / AF | - |
| | Volume-controlled ventilation – Synchronized intermittent mandatory ventilation/AutoFlow,<br>VC – SIMV/AutoFlow | Volume Control - SIMV / AF | - |
| Specification | Subject Device<br>Atlan | Predicate Device<br>Perseus A500 | Reference Device(s) |
| | Volume-controlled ventilation – Synchronized<br>intermittent mandatory ventilation/Pressure<br>support/AutoFlow,<br>VC - SIMV/PS/AutoFlow | Volume Control - SIMV / AF / PS | |
| | Volume-controlled ventilation – Controlled mandatory<br>ventilation,<br>VC - CMV | Volume Control - CMV | |
| | Volume-controlled ventilation – Synchronized<br>intermittent mandatory ventilation,<br>VC - SIMV | | Primus US Apollo (K042607):<br>Volume-controlled ventilation<br>with Synchronization<br>Volume Mode Sync. |
| | Volume-controlled ventilation – Synchronized<br>intermittent mandatory ventilation/Pressure support,<br>VC – SIMV/PS | | Primus US Apollo (K042607):<br>Volume-controlled ventilation<br>with Pressure Support<br>Volume Mode Press. Support |
| Anesthetic ventilator,<br>ventilation modes,<br>applicable to all<br>patient populations,<br>maneuvers | Inspiration hold, or “inspiratory pause” or “manual<br>inspiration”<br>Insp. Hold | | Maquet Flow-i (K191027):<br>Inspiratory Hold |
| | Expiration hold, or “expiratory pause”<br>Exp. Hold | | Maquet Flow-i (K191027):<br>Exspiratory Hold |
| | One-step recruitment, or “sustained inflation” | | GE Aisys CS2 (K170872):<br>Procedure “Vital capacity” |
| | Multi-step recruitment, or “incremental PEEP” | Pressure Control - APRV | GE Aisys CS2 (K170872):<br>Procedure “Cycling” |
| Specification | Subject Device<br>Atlan | Predicate Device<br>Perseus A500 | Reference Device(s) |
| Anesthetic ventilator,<br>additional operation<br>modes | | External fresh-gas outlet (optional) | |
| | Cardiac Bypass Mode (CBM) | Cardiac Bypass Mode (CBM) | |
| | Monitoring mode<br>- the anesthesia machine must be equipped with an<br>integrated respiratory gas measurement module<br>- for patient gas monitoring<br>- no fresh-gas delivery | | Primus US Apollo (K042607):<br>Monitoring mode<br>- for use during standby (not<br>available during automatic<br>ventilation)<br>- no fresh-gas delivery<br>- general time function displayed<br>on screen for timing events |
| | Pause mode<br>- ventilation stopped<br>- if equipped with an electronically controlled gas<br>mixer, gas delivery also stopped<br>- gas concentration measurement active, waiting for<br>respiratory phases<br>- remains in this operation mode until deliberately<br>switched to a specific ventilation mode<br>- configurable Timer [for all patient categories]<br>allows defined period after which an alarm is<br>posted to remind user to initiate ventilation<br>manually<br>- total elapsed time displayed | Pause mode<br>- ventilation is st…