Predicate Devices

K003068, K023289, K040642, K093633, K103625

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ventilator technology and microprocessor control, not AI/ML algorithms.

Therapeutic

Yes
The device is a ventilator, a medical device used to assist or replace breathing for patients, which directly impacts their health and treatment.

Diagnostic

No

Explanation: The Savina 300 is described as a ventilator, which is a therapeutic device used to assist or control breathing, not to diagnose a condition. Its intended use is for ventilation and airway monitoring, not for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "turbine driven ventilator" with a "12.1" color touch screen" and a "ventilation unit... a microprocessor-controlled ventilator," indicating significant hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the Savina 300 is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the Savina 300 is a ventilator for providing respiratory support to patients. This is a life-support device that interacts directly with the patient's respiratory system.
Device Description: The description details a turbine-driven ventilator that controls air and oxygen delivery. This aligns with the function of a respiratory support device, not a device used to examine specimens from the human body.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) or to provide information about a physiological state, health, or disease based on such examination.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. The Savina 300's function is to assist with breathing, which is a therapeutic intervention, not a diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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)

Product codes (comma separated list FDA assigned to the subject device)

CBK

Device Description

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.
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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults and pediatric patients starting from 5 kg (11 lbs) bodyweight.

Intended User / Care Setting

Savina 300 is only intended to be used by trained medical personnel.

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)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance complies with the following standards: IEC 60601-1 : 1988 + A1: 1991 + A2: 1995, IEC 60601-1-2: 2007, IEC 60601-2-12: 2001, IEC 60601-1-4: 1996 + A1: 1999, IEC 60601-1-6 : 2006, IEC 60601-1-8: 2006, ISO 14971: 2007, Corrected version 2007-10-01, ISO 17664: 2004, IEC 62304: 2006, RTCA-DO 160G: 2010 All applicable clauses referring to radiated electromagnetic emissions and mechanical safety, ISO 21647: 2005, ISO 10993-1: 2009 + Cor. 1: 2010, FDA Draft Reviewer Guidance for Ventilators: 1995, ASTM Standard F1100 - 90 (Reapproved 1997).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K003068, K023289, K040642, K093633, K103625

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

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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.

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

2

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Anya C. Harry -S 2014.08.08 10:45:21 -04'00'

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Image /page/3/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue and the background is white. The two dots above the "a" are also blue.

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 (451) 882-3648 Fax No.: + 49 (451) 882-3018

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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Image /page/4/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is in blue color. The two dots above the "a" are also blue. The background is white.

Classification:

Class 2

Regulation No.	Device	Product Code
Preferred Code:
868.5895
For predicates:
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
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.

5

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.

6

Image /page/6/Picture/1 description: The image shows the word "Dräger" in blue font. The font is bold and sans-serif. The two dots above the "a" are also blue. The background is white.

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

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

7

Image /page/7/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue and the background is white. The two dots above the "a" are also blue.

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

Comparison of Technological Characteristics between Savina 300 and Predicates

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

8

SAVINA 300

Image /page/8/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 background is white.

| Specification | Savina 300 SW 4.n | Savina
(legally marketed device) | IACS WS CC
(legally marketed device) | Oxylog 3000 Plus
(legally marketed device) | | | | | |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------|--|----|--|
| Environment of use | Savina 300 is intended for
the following environments
of use:

In intensive care wards, in
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 not mounted on
Savina 300) | - In the Intensive Care
ward, in the recovery room
and generally for hospital
use.
During transfer of
ventilated patients within
the hospital.
During secondary
transport from one hospital
to another. | Suitable for stationary
use in hospitals or
hospital-like facilities or
for intrahospital patient
transport.

Not intended for use in:

In hyperbaric chambers
For magnetic
resonance imaging
(MRT, NMR, NMI)
With flammable gases
or anesthetic agents
In areas with
combustible or explosive
substances
In rooms without
adequate ventilation | - Mobile use for
emergency patients, in
both outdoor and
indoor environments.
During transport in
ambulances or
aircraft, including
helicopters.
In accident and
emergency
departments.
When moving
ventilated patients
around the hospital.
In the recovery room. | | | | | |
| Modes of ventilation | Volume-controlled
ventilation:
VC-CMV
VC-AC
VC-SIMV
VC-MMV
Pressure-controlled
ventilation:
PC-AC,
PC-SIMV+
PC-APRV
Support of spontaneous
breathing:
SPN-CPAP/PS | Volume-controlled
ventilation:
IPPV
IPPV Assist
SIMV
Pressure-controlled
ventilation:
SIMV+
Support of spontaneous
breathing:
CPAP/ASB | Volume-controlled
ventilation:
VC-CMV
VC-AC
VC-SIMV
VC-MMV
Pressure-controlled
ventilation:
PC-AC
PC-SIMV+
PC-APRV
Support of spontaneous
breathing:
SPN-CPAP/PS
SPN-CPAP/VS
SPN-PPS | Volume-controlled
ventilation:
VC-CMV
VC-AC
VC-SIMV/PS
Pressure-controlled
ventilation:
PC-SIMV+
Support of spontaneous
breathing:
SPN-CPAP
SPN-CPAP/PS | | | | | |
| Non Invasive Ventilation | √ | √ | √ | √ | | | | | |
| Pressure Limited Ventilation
(PLV) | Optional in VC modes
without AF | Optional with IPPV, SIMV,
SIMV/ASB | Optional in VC modes
without AF | -- | | | | | |
| Apnea Ventilation | Optional with VC-SIMV,
SPC-CPAP | Optional with SIMV,
SIMV/ASB, CPAP/PS | Optional with PC-SIMV,
PC-BIPAP, VC-MMV,
VC-SIMV, SPN-PPS,
SPN-CPAP, SPN-
CPAP/VS | Optional with SpnCPAP | | | | | |
| Pressure Support (PS)
(Assisted Spontaneous
Breathing) (ASB)) | Oprional with SPN-CPAP,
PC-BIPAP, VC-SIMV | Optional with CPAP,
BIPAP, SIMV | Optional with PC-SIMV,
VC-SIMV, PC-BIPAP,
SPN-CPAP, VC-MMV,
Var. PS | Optional with VC-SIMV,
PC-SIMV+, SpnCPAP | | | | | |
| Flow trigger
Intrinsic PEEP | √
Optional | √
-- | √
Optional | √
-- | | | | | |
| Inspiratory termination criterion | √ | -- | √ | -- | | | | | |
| Sigh | Optional: 2 strokes / 3 min | Optional: 2 strokes / 3 min | Optional: variable | (optional) with VC-CMV,
VC-AC, VC-SIMV | | | | | |
| AutoFlow | (optional) with VC-CMV, VC-
AC, VC-SIMV, VC-MMV | (optional) with IPPV, SIMV | (optional) with VC-CMV,
VC-SIMV, VC-MMV, VC-
AC | | | | | | |
| Special procedures: | - Man. insp./hold
Exp. Hold. | - Insp./hold | - Exp. Hold. | - Insp./hold | | | | | |
| Medication nebulization | optional | optional | optional | -- | | | | | |
| 02 suction | √ | √ | √ | -- | | | | | |
| Therapy types | Monitoring sensors: | - Invasive ventilation (Tube) | | -- | | - Invasive ventilation
(Tube) | | -- | |
| Flow sensor | √ | √ | √ | -- | | | | | |
| Pressure sensor | √ | √ | √ | -- | | | | | |

9

SAVINA 300

Image /page/9/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 horizontally oriented and centered.

| Specification | Savina 300 SW 4.n | Savina
(legally marketed device) | IACS WS CC
(legally marketed device) | Oxylog 3000 Plus
(legally marketed device) |
|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| O2 sensor | ✓ | ✓ | ✓ | -- |
| Proximal temperature sensor | -- | -- | -- | -- |
| CO2 sensor | ✓ (optional) | -- | ✓ | ✓ |
| Ventilation and Device
Monitoring: | | | | |
| Airway pressure, PAW | ✓ | ✓ | ✓ | ✓ |
| Expiratory minute volume, MV | ✓ | ✓ | ✓ | ✓ |
| Inspiratory tidal volume, VTi
Inspiratory O2 concentration,
FiO2 | ✓ | ✓ | ✓ | -- |
| End-expiratory CO2
concentration, etCO2 | ✓ (optional) | -- | ✓ (optional) | ✓ |
| Apnoe time, TApnoe | ✓ | ✓ | ✓ | -- |
| Respiratory rate, fspn | ✓ | ✓ | ✓ | ✓ |
| Logistic alarms (power-, gas
supply failure), machine
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
and set values
Graphic trends | -- | - Lists for measured
values and set values
Graphic trends | -- |
| | Numeric trends | -- | Numeric trends | -- |
| | Loops | -- | Loops | -- |
| | Logbook | -- | Logbook | -- |
| Control principle | time-cycled, volume-
constant, pressure-controlled | time-cycled, volume-
constant, pressure-
controlled | time-cycled, volume-
constant, pressure-
controlled | time-cycled, volume-
constant, pressure-
controlled |
| Software controlled device | Yes | Yes | Yes | Yes |
| Display and control unit | | | | |
| Screen size | 12,1" | -- | 17" | -- |
| Touchscreen | ✓ | -- | ✓ | -- |
| ✓
Operating elements | Large color screen with
information and controls
needed for adjustment
and control of ventilation
therapy. Function softkeys on the
screen for rapid access
and selection of major
functions. Central rotary knob for
adjustment and
confirming settings on
the screen. 6 hard keys for essential
maneuvers and Alarm
reset / Audio paused | -- | Large color screen
with information and
controls needed for
adjustment and
control of ventilation
therapy. Function softkeys on
the screen for rapid
access and selection
of major functions. Central rotary knob
for adjustment and
confirming settings
on the screen. 1 hard keys for audio
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
°F) | -20 to 50 °C (-4 to
122 °F) |
| Atmospheric pressure | 700 to 1060 hPa (10.20 to
15.30 psi) | 700 to 1060 hPa (10.20 to
15.30 psi) | 700 to 1060 hPa (10.20
to 15.30 psi) | 570 to 1200 hPa (8.27 to
17.40 psi) |
| Relative humidity | 5 to 90 % without
condensation | 5 to 90 % without
condensation | 5 to 90 % without
condensation | 5 to 95% without
condensation |
| During operation with expiratory
filter MP01781 | | | | |
| Temperature | 10 to 40 °C (50 to 104 °F) | 10 to 40 °C (50 to 104 °F) | 10 to 40 °C (50 to 104
°F) | -- |
| Specification | Savina 300 SW 4.n | Savina
(legally marketed device) | IACS WS CC
(legally marketed device) | Oxylog 3000 Plus
(legally marketed device) |
| Atmospheric pressure | 700 to 1060 hPa (10.20 to
15.30 psi) | 700 to 1060 hPa (10.20 to
15.30 psi) | 700 to 1060 hPa (10.20
to 15.30 psi) | -- |
| Relative humidity | 10 to 90 % without
condensation | 5 to 90 % without
condensation | 5 to 90 % without
condensation | -- |
| During storage and
transportation | | | | |
| Temperature | -20 to 60 °C (-4 to 140 °F) | -20 to 70 °C (-4 to 158 °F) | -20 to 60 °C (-4 to 140
°F) without PS500
-15 to 40 °C (5 to 104 °F)
with PS500 | -40 to 75 °C (-40 to
167 °F) |
| Atmospheric pressure | 600 to 1200 hPa (8.7 to
17.40 psi) | 600 to 1200 hPa (8.70 to
17.40 psi) | 500 to 1060 hPa (7.25 to
15.37 psi) | 570 to 1200 hPa (8.27 to
17.40 psi) |
| Relative humidity | 10 to 95 % without
condensation | 10 to 95 % without
condensation | 5 to 95 % without
condensation | 5 to 95% without
condensation |
| Operating Data | | | | |
| Mains power supply | | | | |
| Mains power connection | 100 V to 240 V, 50/60 Hz | 100 V to 240 V, 50/60 Hz | 100 V to 240 V, 50/60 Hz | 100 V to 240 V,
50/ 60 Hz |
| Current consumption | | | | 2.6 A (-4 to 104 °F) /
1.3 A (104° to 122 °F) |
| At 230 V | max. 1.3 A | max. 1.1 A | max. 0.8 A Ventilation
Unit with Medical Cockpit | -- |
| At 100 V | max. 3.4 A | max. 3.4 A | max. 1.8 A Ventilation
Unit with Medical Cockpit | -- |
| Protection Class | | | | |
| Temp.Sensor AWT01
(sensor connected) | Type BF | Type BF | Type BF | Type BF |
| Expiratory valve and
breathing hoses | Type BF | Type BF | Type BF | Type BF |
| CO2 sensor (sensor
fitted) | Type BF | Type BF | Type BF | -- |
| Internal battery | | | | |
| Type | Lead-acid gel batteries,
sealed, maintenance-free | Lead-acid gel batteries,
sealed, maintenance-free | NiMH battery, sealed,
maintenance-free | Lithium ion battery |
| Capacity | 3.5 Ah | 3.5 Ah | 2.5 Ah | 2.4 Ah |
| Voltage | 24 V | 24 V | 24 V | 19 V |
| Time bridged following
a mains power failure with new
and fully charged
internal
battery | typ. 45 min | min. 30 minutes (typically
40 minutes) | min. 30 minutes | 4 hours |
| Gas supply | | | | |
| O2 gauge pressure | 3 bar (43.5 psi) -10 % to 6.0
bar (87 psi) | 3 bar (43.5 psi) -10 % to
6.0 bar (87 psi) | -- | -- |
| 02 peak input flow | 180 L/min (at 2.8 bar input
pressure) | 180 L/min (at 2.8 bar input
pressure) | 130 L/min (at 2.8 bar
(40.6 psi) input pressure)
180 L/min (at 4.0 bar
(58.0 psi) input pressure) | -- |
| Dew point | 5 °C (41 °F) below ambient
temperature | 5 °C (41 °F) below ambient
temperature | 5 °C (41 °F) below
ambient temperature | -- |
| Oil concentration |