SAVINA 300 SAVINA 300, COUNTRY VARIANTS

K121886 · Draeger Medical GmbH · CBK · Aug 8, 2014 · Anesthesiology

Device Facts

• Record ID: K121886
• Device Name: SAVINA 300 SAVINA 300, COUNTRY VARIANTS
• Applicant: Draeger Medical GmbH
• Product Code: CBK · Anesthesiology
• Decision Date: Aug 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients starting from 5 kg (111bs) bodyweight. Savina 300 offers mandatory ventilation modes supporting spontaneous breathing, and airway monitoring. Savina 300 is intended for the following environments of use: - In intensive care wards, recovery rooms and generally for hospital use - During the transport of ventilated patients within the hospital - During secondary transport from one hospital to another (without trolley, monitor not mounted on Savina 300) - During transport flights with aircraft (without trolley, monitor is not mounted on Savina 300)

Device Story

Savina 300 is a turbine-driven, microprocessor-controlled intensive care ventilator. It takes ambient air as input, with optional O2 from central supply, bottles, or low-pressure sources. It provides pressure- and volume-controlled mandatory and spontaneous breathing modes (e.g., VC-CMV, VC-SIMV, PC-APRV, SPN-CPAP/PS). The device features a 12.1" color touchscreen for displaying waveforms, numeric parameters, trends, and loops. It is operated by trained medical personnel in hospitals or during transport. The system monitors airway pressure, tidal volume, FiO2, and respiratory rate, triggering visual/audible alarms if parameters exceed preset limits. It includes AutoFlow to regulate inspiratory flow and avoid pressure peaks, and supports CO2 measurement. The device interfaces with Dräger equipment and third-party devices via MEDIBUS. It benefits patients by providing automated, synchronized respiratory support and continuous monitoring across various clinical environments.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-12, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-1-8, ISO 14971, ISO 17664, IEC 62304, RTCA-DO 160G, ISO 21647, ISO 10993-1, and ASTM F1100-90.

Technological Characteristics

Turbine-driven, microprocessor-controlled ventilator. 12.1" color touchscreen interface with rotary knob. Materials comply with ISO 10993-1. Connectivity via MEDIBUS. Power: 100-240V AC or internal lead-acid gel battery (3.5 Ah). Sterilization: Reprocessing per ISO 17664. Software: IEC 62304 compliant. Features include flow/pressure sensors, optional CO2 monitoring, and O2 suction.

Indications for Use

Indicated for ventilation of adult and pediatric patients ≥ 5 kg bodyweight in intensive care, recovery, hospital settings, and during intra-hospital or secondary transport (including aircraft).

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• Savina (K003068)
• Savina NIV Option (K023289)
• Savina with LPO (K040642)
• Infinity Acute Care System Workstation Critical Care (K093633)
• Oxylog 3000 Plus (K103625)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 8, 2014

Dräger Medical GmbH Mr. Ulrich Schröder Director Regulatory & Clinical Affairs Moislinger Allee 53-55 23542 Luebeck, Germany

Re: K121886

Trade/Device Name: Savina 300 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: June 10, 2014 Received: June 16, 2014

Dear Mr. Schröder:

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. 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.

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Page 2 - Mr. Schroeder

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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### Indications for Use

510(k) Number (if known) K121886

Device Name

SAVINA 300

Indications for Use (Describe)

Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients starting from 5 kg (111bs) bodyweight.

Savina 300 offers mandatory ventilation modes supporting spontaneous breathing, and airway monitoring.

Savina 300 is intended for the following environments of use:

- In intensive care wards, recovery rooms and generally for hospital use

- During the transport of ventilated patients within the hospital
- During secondary transport from one hospital to another (without trolley, monitor not mounted on Savina 300)

- During transport flights with aircraft (without trolley, monitor is not mounted on Savina 300)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary according to 21 CFR 807.92

#### Applicants Name and Address:

Draeger Medical GmbH Moislinger Allee 53-55 23542 Luebeck Germany

Establishment Registration Number: 9611500

#### Contact Person:

Ulrich Schröder Director Regulatory & Clinical Affairs

Tel. No.: + 49 [phone] Fax No.: + 49 [phone]

#### Applicants US Contact Person

Beth Zis Director Regulatory Affairs

Tel. No.: 978 3798 285 Fax No.: 978 3798 335

#### Date submission was prepared:

June 2012

#### Device Name:

Trade Name: Savina 300 Common Name: Intensive Care Ventilator

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#### Classification:

Class 2

| Regulation No. | Device | Product Code |
|------------------------------------------------------------|--------------------------------------|--------------|
| Preferred Code:<br>868.5895<br>For predicates:<br>868.5895 | Ventilator, continuous, facility use | 73CBK |
| | Ventilator, continuous, facility use | 73CBK |

#### Reason for the 510(k): Substantial Equivalence

The technological concept of the Savina 300 is equivalent to Savina. The functionality is equivalent to the Infinity Acute Care System Workstation Critical Care and the flight transport indication is equivalent to the Oxylog 3000 Plus.

| 510(k) No. | Trade name | Company |
|------------|---------------------------------------------------------|----------------------|
| K003068 | Savina | Draeger Medical GmbH |
| K023289 | Savina NIV Option | Draeger Medical GmbH |
| K040642 | Savina with LPO | Draeger Medical GmbH |
| K093633 | Infinity Acute Care System<br>Workstation Critical Care | Draeger Medical GmbH |
| K103625 | Oxylog 3000 Plus | Draeger Medical GmbH |

#### Legally Marketed Device to which Substantial Equivalence is claimed:

#### Executive Summary

This submission comprises the critical care ventilator Savina 300 for the ventilation of adult and pediatric patients in intensive care units, in recovery rooms and generally for hospital use. Savina 300 is also intended during the transport of ventilated patients within the hospital, during secondary transport from one hospital to another and during transport flights with fixed-wing aircraft.

Savina 300 is a turbine driven ventilator with a 12.1" color touch screen for easy handling, providing tube and mask based ventilation capabilities. Air is taken from ambient. O2 can be taken from central gas supply, bottle supply (with appropriated accessories) or from another low pressure oxygen source (LPO).

The ventilation unit of the Savina 300 is a microprocessor-controlled ventilator. The Savina 300 provides overpressure ventilation and adjustable oxygen concentration with pressureand volume-controlled automatic and spontaneous breathing modes.

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Image /page/5/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue and the two dots above the "a" are also blue. The word is the logo for the Dräger company, which is a German company that makes medical and safety technology.

Savina 300 provides the following ventilation modes:

Volume-controlled ventilation:

- · VC-CMV (Volume Control-Continuous Mandatory Ventilation)
- · VC-AC (Volume Control-Assist Control)
- · VC-SIMV (Volume Control-Synchronized Intermittent Mandatory Ventilation)
- · VC-MMV (Volume Control-Mandatory Minute Volume Ventilation)

Pressure-controlled ventilation:

- · PC-SIMV+ (Pressure Control Synchronized Intermittent Mandatory Ventilation plus)
- · PC-APRV (Pressure Control Airway Pressure Release Ventilation)
- · PC-AC (Pressure Control Assist Control)

Support of spontaneous breathing:

· SPN-CPAP (Spontaneous-Continuous Positive Airway Pressure)

Additionally the ventilation unit features special modes to complement the ventilation modes. If breathing of a spontaneously breathing patient stop, Apnea Ventilation switches over automatically to volume-controlled mandatory ventilation.

By switching on the flow trigger, the mandatory strokes are synchronized with the patient's spontaneous breathing attempts.

With AutoFlow, the inspiration flow is decelerated and regulated and thus pressure peaks can be avoided.

The human interface supports simultaneous display of patient waveforms, parameter data, alarm display and annunciation.

The Savina 300 produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits. The Savina 300 can interface with specific Dräger Medical therapeutically and diagnostic equipment, as well as third party devices via a MEDIBUS data connection.

Savina 300 provides CO2 measurement as waveform and end tidal CO2 measurement.

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#### Indications for Use:

Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients starting from 5 kg (11lbs) bodyweight.

Savina 300 offers mandatory ventilation modes, ventilation modes supporting spontaneous breathing, and airway monitoring.

Savina 300 is intended for the following environments of use:

- In intensive care wards, recovery rooms and generally for hospital use

- During the transport of ventilated patients within the hospital

- During secondary transport from one hospital to another (without trolley, monitor not mounted on Savina 300)

- During transport flights with aircraft (without trolley, monitor is not mounted on Savina 300)

#### List of Performance Testing:

Performance complies with the following standards:

| Applied external Standards | |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 : 1988 + A1: 1991<br>+ A2: 1995 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance |
| IEC 60601-1-2: 2007 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral standard:<br>Electromagnetic compatibility - Requirements and<br>tests |
| IEC 60601-2-12: 2001 | Medical electrical equipment - Part 2-12:<br>Particular Requirements for the safety of lung<br>ventilators - critical care ventilators |
| IEC 60601-1-4: 1996 + A1: 1999 | Medical Electrical Equipment - Part 1-4: General<br>requirements for safety - Collateral standard:<br>Programmable Electrical Medical Systems |
| IEC 60601-1-6 : 2006 | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential<br>performance - Collateral standard - Usability |
| IEC 60601-1-8: 2006 | Medical electrical equipment - Part 1-8: General<br>requirements for basic safety and essential<br>performance - Collateral standard: General<br>requirements, tests and guidance for alarm<br>systems in medical electrical equipment and<br>medical electrical systems |
| ISO 14971: 2007, Corrected<br>version 2007-10-01 | Medical devices - Application of risk management<br>to medical devices |
| ISO 17664: 2004 | Sterilization of medical devices - information to<br>be provided by the manufacturer for the<br>reprocessing of resterilizable medical devices |
| IEC 62304: 2006 | Medical Device Software - Software Life Cycle<br>Processes |

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| Applied external Standards | |
|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| RTCA-DO 160G: 2010<br>All applicable clauses referring<br>to radiated electromagnetic<br>emissions and mechanical<br>safety | Environment Conditions and Test Procedures for<br>Airborne Equipment |
| ISO 21647: 2005 | Medical electrical equipment - Particular<br>requirements fort he basic safety and essential<br>performance of respiratory gas monitors with<br>Technical Corrigendum |
| ISO 10993-1: 2009 + Cor. 1:<br>2010 | Biological Evaluation of medical devices - Part 1:<br>Evaluating and testing |
| FDA Draft Reviewer Guidance<br>for Ventilators: 1995 | |
| ASTM Standard F1100 - 90<br>(Reapproved 1997) | Standards Specification for Ventilators Intended<br>for Use in Critical Care |

## Comparison of Technological Characteristics between Savina 300 and Predicates

| Specification | Savina 300 SW 4.n | Savina<br>(legally marketed device) | IACS WS CC<br>(legally marketed device) | Oxylog 3000 Plus<br>(legally marketed device) |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer<br>US FDA 510(k) number | Dräger Medical GmbH<br>K121886 | Dräger Medical GmbH<br>K003068 (Savina) | Dräger Medical GmbH<br>K093633 | Dräger Medical GmbH<br>K103625 |
| | | K023289 (NIV Option)<br>K040642 (LPO Option) | | |
| FDA Regulation number | To be assigned | 868.5895 | 868.5895 | 868.5895 |
| FDA Product code | CBK | CBK | CBK | CBK |
| FDA Classification | Continuous ventilator,<br>Class 2 | Continuous ventilator,<br>Class 2 | Continuous ventilator,<br>Class 2 | Continuous ventilator,<br>Class 2 |
| Intended use | Savina 300 is a ventilator<br>intended for the ventilation of<br>adults and pediatric patients<br>starting from 5 kg (11 lbs)<br>bodyweight. | Long-term ventilator for<br>intensive care. For patients<br>requiring 50 mL tidal<br>volume upwards. | The Infinity Acute Care<br>System Workstation<br>Critical Care (in the<br>following called IACS WS<br>CC) is intended for the<br>ventilation of adult,<br>pediatric and neonatal<br>patients. | The Oxylog 3000 plus is<br>a time-cycled, volume<br>controlled and pressure<br>controlled emergency<br>and transport ventilator<br>for patients requiring<br>mandatory or assisted<br>ventilation with a tidal<br>volume from 50 mL<br>upwards. |
| Intended User | Savina 300 is only intended<br>to be used by trained<br>medical personnel | Savina is only intended to<br>be used by trained medical<br>personnel | IACS WS CC is only<br>intended to be used by<br>trained medical<br>personnel | Oxylog 3000 plus is only<br>intended to be used by<br>trained medical<br>personnel |

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## SAVINA 300

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| Specification | Savina 300 SW 4.n | Savina<br>(legally marketed device) | IACS WS CC<br>(legally marketed device) | Oxylog 3000 Plus<br>(legally marketed device) | | | | | |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------|--|----|--|
| Environment of use | Savina 300 is intended for<br>the following environments<br>of use:<br>- In intensive care wards, in<br>recovery rooms and<br>generally for hospital use<br>- During the transport of<br>ventilated patients within the<br>hospital<br>- During secondary transport<br>from one hospital to another<br>(without trolley, monitor not<br>mounted on Savina 300)<br>- During transport flights<br>with aircraft (without trolley,<br>monitor not mounted on<br>Savina 300) | - In the Intensive Care<br>ward, in the recovery room<br>and generally for hospital<br>use.<br>- During transfer of<br>ventilated patients within<br>the hospital.<br>- During secondary<br>transport from one hospital<br>to another. | Suitable for stationary<br>use in hospitals or<br>hospital-like facilities or<br>for intrahospital patient<br>transport.<br><br>Not intended for use in:<br>- In hyperbaric chambers<br>- For magnetic<br>resonance imaging<br>(MRT, NMR, NMI)<br>- With flammable gases<br>or anesthetic agents<br>- In areas with<br>combustible or explosive<br>substances<br>- In rooms without<br>adequate ventilation | - Mobile use for<br>emergency patients, in<br>both outdoor and<br>indoor environments.<br>- During transport in<br>ambulances or<br>aircraft, including<br>helicopters.<br>- In accident and<br>emergency<br>departments.<br>- When moving<br>ventilated patients<br>around the hospital.<br>- In the recovery room. | | | | | |
| Modes of ventilation | Volume-controlled<br>ventilation:<br>VC-CMV<br>VC-AC<br>VC-SIMV<br>VC-MMV<br>Pressure-controlled<br>ventilation:<br>PC-AC,<br>PC-SIMV+<br>PC-APRV<br>Support of spontaneous<br>breathing:<br>SPN-CPAP/PS | Volume-controlled<br>ventilation:<br>IPPV<br>IPPV Assist<br>SIMV<br>Pressure-controlled<br>ventilation:<br>SIMV+<br>Support of spontaneous<br>breathing:<br>CPAP/ASB | Volume-controlled<br>ventilation:<br>VC-CMV<br>VC-AC<br>VC-SIMV<br>VC-MMV<br>Pressure-controlled<br>ventilation:<br>PC-AC<br>PC-SIMV+<br>PC-APRV<br>Support of spontaneous<br>breathing:<br>SPN-CPAP/PS<br>SPN-CPAP/VS<br>SPN-PPS | Volume-controlled<br>ventilation:<br>VC-CMV<br>VC-AC<br>VC-SIMV/PS<br>Pressure-controlled<br>ventilation:<br>PC-SIMV+<br>Support of spontaneous<br>breathing:<br>SPN-CPAP<br>SPN-CPAP/PS | | | | | |
| Non Invasive Ventilation | √ | √ | √ | √ | | | | | |
| Pressure Limited Ventilation<br>(PLV) | Optional in VC modes<br>without AF | Optional with IPPV, SIMV,<br>SIMV/ASB | Optional in VC modes<br>without AF | -- | | | | | |
| Apnea Ventilation | Optional with VC-SIMV,<br>SPC-CPAP | Optional with SIMV,<br>SIMV/ASB, CPAP/PS | Optional with PC-SIMV,<br>PC-BIPAP, VC-MMV,<br>VC-SIMV, SPN-PPS,<br>SPN-CPAP, SPN-<br>CPAP/VS | Optional with SpnCPAP | | | | | |
| Pressure Support (PS)<br>(Assisted Spontaneous<br>Breathing) (ASB)) | Oprional with SPN-CPAP,<br>PC-BIPAP, VC-SIMV | Optional with CPAP,<br>BIPAP, SIMV | Optional with PC-SIMV,<br>VC-SIMV, PC-BIPAP,<br>SPN-CPAP, VC-MMV,<br>Var. PS | Optional with VC-SIMV,<br>PC-SIMV+, SpnCPAP | | | | | |
| Flow trigger<br>Intrinsic PEEP | √<br>Optional | √<br>-- | √<br>Optional | √<br>-- | | | | | |
| Inspiratory termination criterion | √ | -- | √ | -- | | | | | |
| Sigh | Optional: 2 strokes / 3 min | Optional: 2 strokes / 3 min | Optional: variable | (optional) with VC-CMV,<br>VC-AC, VC-SIMV | | | | | |
| AutoFlow | (optional) with VC-CMV, VC-<br>AC, VC-SIMV, VC-MMV | (optional) with IPPV, SIMV | (optional) with VC-CMV,<br>VC-SIMV, VC-MMV, VC-<br>AC | | | | | | |
| Special procedures: | - Man. insp./hold<br>- Exp. Hold. | - Insp./hold | - Exp. Hold. | - Insp./hold | | | | | |
| Medication nebulization | optional | optional | optional | -- | | | | | |
| 02 suction | √ | √ | √ | -- | | | | | |
| Therapy types | Monitoring sensors: | - Invasive ventilation (Tube) | | -- | | - Invasive ventilation<br>(Tube) | | -- | |
| Flow sensor | √ | √ | √ | -- | | | | | |
| Pressure sensor | √ | √ | √ | -- | | | | | |

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## SAVINA 300

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| Specification | Savina 300 SW 4.n | Savina<br>(legally marketed device) | IACS WS CC<br>(legally marketed device) | Oxylog 3000 Plus<br>(legally marketed device) |
|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| O2 sensor | ✓ | ✓ | ✓ | -- |
| Proximal temperature sensor | -- | -- | -- | -- |
| CO2 sensor | ✓ (optional) | -- | ✓ | ✓ |
| Ventilation and Device<br>Monitoring: | | | | |
| Airway pressure, PAW | ✓ | ✓ | ✓ | ✓ |
| Expiratory minute volume, MV | ✓ | ✓ | ✓ | ✓ |
| Inspiratory tidal volume, VTi<br>Inspiratory O2 concentration,<br>FiO2 | ✓ | ✓ | ✓ | -- |
| End-expiratory CO2<br>concentration, etCO2 | ✓ (optional) | -- | ✓ (optional) | ✓ |
| Apnoe time, TApnoe | ✓ | ✓ | ✓ | -- |
| Respiratory rate, fspn | ✓ | ✓ | ✓ | ✓ |
| Logistic alarms (power-, gas<br>supply failure), machine<br>malfunction | ✓ | ✓ | ✓ | ✓ |
| Displays | - Curves; three at a time | -- | - Curves; four at a time | - Curve |
| | - Numeric parameters | - Numeric parameters | - Numeric parameters | - Numeric parameters |
| | - Lists for measured values<br>and set values<br>Graphic trends | -- | - Lists for measured<br>values and set values<br>Graphic trends | -- |
| | Numeric trends | -- | Numeric trends | -- |
| | Loops | -- | Loops | -- |
| | Logbook | -- | Logbook | -- |
| Control principle | time-cycled, volume-<br>constant, pressure-controlled | time-cycled, volume-<br>constant, pressure-<br>controlled | time-cycled, volume-<br>constant, pressure-<br>controlled | time-cycled, volume-<br>constant, pressure-<br>controlled |
| Software controlled device | Yes | Yes | Yes | Yes |
| Display and control unit | | | | |
| Screen size | 12,1" | -- | 17" | -- |
| Touchscreen | ✓ | -- | ✓ | -- |
| ✓<br>Operating elements | Large color screen with<br>information and controls<br>needed for adjustment<br>and control of ventilation<br>therapy. Function softkeys on the<br>screen for rapid access<br>and selection of major<br>functions. Central rotary knob for<br>adjustment and<br>confirming settings on<br>the screen. 6 hard keys for essential<br>maneuvers and Alarm<br>reset / Audio paused | -- | Large color screen<br>with information and<br>controls needed for<br>adjustment and<br>control of ventilation<br>therapy. Function softkeys on<br>the screen for rapid<br>access and selection<br>of major functions. Central rotary knob<br>for adjustment and<br>confirming settings<br>on the screen. 1 hard keys for audio<br>paused | -- |
| Environmental Conditions | | | | |
| During operation | | | | |
| Temperature | 5 to 40 °C (41 to 104 °F) | 10 to 40 °C (50 to 104 °F) | 10 to 40 °C (50 to 104<br>°F) | -20 to 50 °C (-4 to<br>122 °F) |
| Atmospheric pressure | 700 to 1060 hPa (10.20 to<br>15.30 psi)…