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Servo-air Lite Ventilator System is an assist ventilation in spontaneously breathing patients who require mechanical ventilation due to respiratory failure or chronic respiratory insufficiency. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring. Servo-air Lite Ventilator System is intended for adult and pediatric patients weighing 15 kg and above. Servo-air Lite Ventilator System is to be used only by healthcare professionals. Servo-air Lite Ventilator System is to be used only in professional health care facilities and for transport within these facilities. It is not intended for transport between health care facilities.

The Servo-air Lite Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The Servo-air Lite Ventilator System is based on the cleared reference device Servo-air Ventilator System (K192604), with additions based on reference device Servo-u Ventilator System (K201874). The ventilator delivers controlled or supported breaths to the patient, with constant pressure, using a set oxygen concentration. The ventilator can also deliver High Flow therapy with a constant flow. Servo-air Lite contains a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard). Accessories for CO2 monitoring are available as options. The Servo-air Lite Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings. The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.

The Servo-u Ventilator System is: - intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients - to be used only by healthcare providers - to be used only in professional healthcare facilities and for transport within these facilities The Servo-n Ventilator System is: - intended for respiratory support, monitoring and treatment of neonatal and pediatric patients - to be used only by healthcare providers - to be used only in professional healthcare facilities and for transport within these facilities The Servo-u MR Ventilator System is: - intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients - to be used only by healthcare providers - to be used only in professional healthcare facilities and for transport within these facilities - to be used in MR environment according to specified conditions - with 1.5 T or 3 T MR scanners - outside magnetic fields >20 mT/200 Gauss

The Servo-u/n/u MR Ventilator Systems 4.1 consist of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The Servo-u/n/u MR Ventilator Systems 4.1 are based on the cleared predicate device Servo-u/n Ventilator Systems 2.1 (K180098) with some improvements. The ventilation modes in the Servo-u/n/u MR 4.1 are the same as the predicate device. Standard configurations of available modes and optional modes do differ between the devices, i.e. Servo-u/n/u MR 4.1. The ventilators deliver controlled or supported breaths to the patient, with constant flow, constant pressure, using a set oxygen concentration. The ventilators can also deliver High Flow therapy with a constant flow. The Electrical activity of the diaphragm (Edi) is a measurement of the patients own breathing efforts. The Edi functionality makes it possible to monitor Edi activity in all ventilation modes, High Flow therapy as well as in Standby. NAVA stands for Neurally Adjusted Ventilatory Assist and is a supported mode of ventilation based on the Edi, delivering assist in proportion to and synchronized with the patient's respiratory drive. NAVA is available as an invasive and a non-invasive mode. The included parts related to this mode, such as Edi module and Edi catheters are identical to the cleared predicate devices Servo-u/n 2.1 (K180098). Servo-u/n contain a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard). It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098). Not available on Servo-u MR. Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098). The Servo-u/n/u MR Ventilator Systems will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings. The alarm handling is similar to the one used in the cleared predicate devices Servo-u/n 2.1 (K180098). The Servo-u/n/u MR Ventilator Systems contain provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport. The batteries are identical to the one used for the cleared predicate devices Servo-u/n 2.1 (K180098).

The indication for Flow-c/Flow-e Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration. The indication for the Flow-i/Flow-c/Flow-e Anesthesia system is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

Flow-i, Flow-c and Flow-e Anesthesia systems within the Flow Anesthesia family 4.7 are high-performance Anesthesia systems designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult. Flow Anesthesia family is a software-controlled semi-closed system for inhalation Anesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide). The Flow-i/-c/-e 4.7 consists of a core, where gases are mixed and administered, and a User Interface where the settings are made and ventilation and anesthesia are monitored. The Flow-i/-c/-e 4.7 is based on the cleared predicate device FLOW-i 4.2 (K160665) with some improvements.

The Servo Guard is a bacterial/viral filter for applications in respiratory care.The filter is intended to be used in patient circuits to reduce the spread of viruses and bacteria from patient/persomel and to protect the patient circuits and ventilators from contamination. The filter shall only be used with the ventilators Servo-i and Servo-s.

A Breathing Circuit Bacteria Filter is intended to protect from contamination as well as to reduce particles such as dust and microbiological matters from gases used in the patient circuit of a respiratory device. The bacterial/viral filter is a disposable accessory normally used on the expiratory limb of the ventilator breathing system to reduce possible cross contamination between patient and equipment and between patient. It can also be used on the inspiratory pipe, in order to reduce dust particles to the patient.

The SERVO-U ventilator system is: - intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients - to be used only by healthcare providers - to be used only in professional healthcare facilities and for transport within these facilities For NAVA and Edi monitoring, it is in addition intended: - to provide monitoring of the patient's breathing drive - to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active - for use on all patients with no contraindication for insertion/exchange of a nasogastric tube The SERVO-n ventilator system is: - intended for respiratory support, monitoring and treatment of neonatal and pediatric patients - to be used only by healthcare providers - to be used only in professional healthcare facilities and for transport within these facilities For NAVA and Edi monitoring, it is in addition intended: - to provide monitoring of the patient's breathing drive - to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active - for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-U/n 2.1 is available in two models, SERVO-U and SERVO-n. The SERVO-U/n 2.1 consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The SERVO-U/n 2.1 is based on the cleared predicate device SERVO-U/n 1.1 (K151814), with some improvements. The ventilation modes in the SERVO-U/n 2.1 are similar as in the predicate device, even though the standard configurations of available modes and optional modes differ between the devices, i.e. SERVO-U, SERVO-n and the cleared predicate device SERVO-U/n 1.1. The ventilator delivers controlled or supported breaths to the patient, with constant flow, constant pressure or pressure proportional to the Edi signal (the electrical activity of the diaphragm) of the patient, using a set oxygen concentration. SERVO-U/n contains a dedicated controller circuit for the Aerogen Pro and Solo nebulizers (included as standard). Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. The SERVO-U/n Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and produce alarm recordings. The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.

The indication for FLOW-i Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

FLOW-i Anesthesia System is a Anesthesia system designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult. FLOW-i Anesthesia System is a software-controlled semi-closed system for inhalation Anesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide). The most important performance features of the FLOW-i Anesthesia System are: - a ventilator whose functionality is based on ICU-ventilator technology, o - the volume reflector technology. O - the electronically controlled injector vaporizers and o - the ergonomic design. O This 510(k) submission for the FLOW-i Anesthesia System is based on the following modifications: - Updates of the product for compliance with 3td edition of the 60601 standard package . - IEC 60601-1:2005 O - ISO 80601-2-13:2011 o - ISO 80601-2-55:2011 O - Implementation of a new function that provides recommended ventilation values (PBW) - Possibility to set a lower alarm limit for the Airway pressure alarm: High - Display of Airway resistance measurement following an Inspiratory and/or Expiratory Hold

The Edi catheter ENFit is intended for: - . Administrating nutrition, fluids and medications via the naso-gastro-enteric route - . Aspiration via the naso-gastroenteric route - . Transfers electrical activity (Edi signals) to compatible SERVO ventilator systems on which NAVA and NAVA NIV are available

The Edi Catheter ENFit is a sterile, single use nasogastric feeding tube that carries electrode rings that record diaphragm electrical activity (Edi signal). The Edi Catheter ENFit is an accessory to be used with patients in the range of neonates, infants, and adults together with the SERVO ventilator system. The Edi signal is used as an additional detector to improve the synchrony between the patient and the ventilator and to give the patient corresponding ventilatory support in the ventilation modes NAVA and NIV NAVA. As a nasogastric feeding tube, the Edi Catheter ENFit is used for administration of nutrition, fluids and medications, as well as and aspiration via the naso-gastroenteric route. For the 12 Fr and 16 Fr catheters, a sump lumen is available for air venting the feeding tube to the atmosphere. The new ENFit connector which is compliant with ISO 80369-3 is introduced in order to avoid misconnections with small-bore connectors used for other healthcare applications than enteral feeding.

The SERVO-U ventilator system is: - intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients - to be used only by healthcare providers - to be used only in professional healthcare facilities and for transport within these facilities For NAVA and Edi monitoring, it is in addition intended: - to provide monitoring of the patient's breathing drive - to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active - for use on all patients with no contraindication for insertion/exchange of a nasogastric tube The SERVO-n ventilator system is: - intended for respiratory support, monitoring and treatment of neonatal and pediatric patients - to be used only by healthcare providers - to be used only in professional healthcare facilities and for transport within these facilities For NAVA and Edi monitoring, it is in addition intended: - to provide monitoring of the patient's breathing drive - to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active - for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

The SERVO-U/n Ventilator System is available in two models, SERVO-U and SERVOn. The SERVO-U/n Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The SERVO-U/n Ventilator System is built on the same architecture as the cleared predicate device SERVO-i Ventilator System (K123149). The ventilation modes in the SERVO-U/n Ventilator System are identical to the ventilation modes in the cleared predicate device, even though the standard configurations of available modes and optional modes differ between the devices i.e. SERVO-U, SERVO-n and the cleared predicate device SERVO-i Ventilator System (K123149). The ventilator delivers controlled or supported breaths to the patient, with constant flow. constant pressure or pressure proportional to the Edi signal (the electrical activity of the diaphragm) of the patient, using a set oxygen concentration. NAVA (Neurally Adiusted Ventilatory Assist) is a supported mode for SERVO-U/n that uses the Edi signal as an addition to the flow/pressure trigger to synchronize the patient efforts with the onset and cycle off of supported breaths. NAVA is available in invasive and non-invasive modes. These ventilation modes are identical in the SERVO-U/n Ventilation system and the cleared predicate device SERVO-i Ventilator System (K123149). Furthermore, the included hardware parts Edi module and Edi catheters are also identical to the ones used for the cleared predicate device SERVO-i Ventilator System (K123149). SERVO-U/n contains a dedicated controller circuit for the Aerogen Pro and Solo nebulizers (included as standard). In the cleared predicate device SERVO-i Ventilator System (K123149) the corresponding nebulizer function is available as an optional module. Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. The CO2 monitoring option is updated with Capnostat 5 and the Y sensor is based on a new technology and measuring function compared to the corresponding options for the cleared predicate device SERVO-i Ventilator System (K123149). The SERVO-U/n Ventilator System will produce visual and audible alarms if any parameter varies beyond preset or default limits and produce alarm recordings. The alarm handling is very similar to the one used in the cleared predicate device SERVO-i Ventilator System (K123149), except the possibility to set alarm off for leakage related alarms in Neonatal Patient category when leakage compensation is activated. Additionally, an Inspiratory tidal volume (VT) too high alarm has been added in the neonatal patient category and three alarms have been removed in the Non-invasive modes. The system contains provisions for battery modules to supply the system in the case of mains power failure or during in-hospital transport. The batteries are identical to the one used for the cleared predicate device SERVO-i Ventilator System (K123149). System parts: The SERVO-U/n Ventilator System consists of the following parts: - User interface, where all user interactions are performed. - Patient unit with all connections to the patient, to power and gases. - Mobile cart, on wheels, for using the ventilator on either the left or the right side of the patient.

The guide wire is intended to be used as a stylet into the MAQUET Edi Catheter to stiffen it in order to simplify its placement in the intended patient population comprising adult, pediatric, infant and neonatal patients.

The function of the Guide wire for Edi Catheters is to provide the necessary stiffness to facilitate the clinicians in the placement of the Maquet Critical Care AB nasogastric feeding tube called Edi Catheter. The guide wire is inserted as a stylet into the feeding lumen of the Edi catheter prior to insertion of the Edi catheter in the patient and is removed right after the placement of the Edi catheter is completed. The Guide wire for Edi Catheter consists of symmetrical stainless steel wire surrounded by a spiral stainless steel wire which is PTFE (polytetrafluoro-ethylene) coated. It also has soft and rounded ends. A safety ribbon runs thru the length of the Guide wire and is welded at each end to contain the coil of the spring. The Guide wire for Edi Catheter is provided in a non-sterile package and is for single use only. The individually packed Guide wires are delivered to the customer in an outer plastic bag containing five (5) Guide wires.

The SERVO i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants, and adults with respiratory failure or respiratory insufficiency. SERVO-i is a ventilator system to be used only by healtheare providers in hospitals or healthcare facilities and for in-hospital transport. The added indications for use of the NAVA option is when the electrical signal from the diaphragm is intact; NA VA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso-Gastric tube. The SERVO-i Ventilator is classified as MR Conditional for 1.T. 1.5T and 3T MR scanners. This means that it is safe to use in the MR environment if the MR Environment Declaration for SERVO-i are met. The SERVO-i Ventilator System with Heliox option is indicated for use with the delivery of Air, Oxygen, or Heliox (a mixture of Helium and Oxygen). The SERVO-s Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants, and adults with respiratory failure or respiratory insufficiency. SERVO-s is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.

The SERVO-i Ventilator System (here after called SERVO-i) is intended to provide continuous ventilation for neonate to adult patients in the weight range 0.5-250 kg and with tidal volumes from 2 mL to 4000 mL. SERVO-i consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The ventilator delivers controlled or supported breaths to the patient, with either constant flow or constant pressure, using a set oxygen concentration. SERVO-i will produce visual and audible alarms if vital parameters vary beyond pre-set, or default, limits. The system contains provisions for at least two battery modules to supply the system in the case of mains power failure or during in-hospital transport. The ventilator functionality is controlled by software. The SERVO-i Ventilator System is available in three software versions. Infant. Adult and Universal. The NAVA (Neurally Adjusted Ventilatory Assist) option is a supported mode for SERVO-i that uses the Edi signal (the electrical activity of the diaphragm) as an addition to the flow/pressure trigger to synchronize the patient efforts with the onset and cycle off. The NAVA option is available in invasive and non-invasive mode. SERVO-i is MR conditional. The SERVO-i ventilator with MR option have been tested with 1.0, 1.5, 3.0 T scanners without impairing its performance or the image quality of the scanner. Each scanner and its environment form an individual device. The MR Environment Declaration describes how a SERVO-i with MR option can be qualified to be used with an MR scanner forming a safe Medical System. All vital parts of the ventilator have been tested for performance in excessive magnetic fields. The SERVO-i with Heliox option requires a different mechanical adaptor on the air supply inlet to allow a mixture of Helium and Oxygen to be connected. Furthermore is the software updated to allow safe delivery and monitoring of the Heliox gas mixture. Accessories for CO2-monitoring, nebulization and flow monitoring at the Y -piece (Y-sensor) are integrated as options in the SERVO-i and the drivers are controlled by the software in the ventilator. This 510(k) submission for the SERVO-i include changes to receive a new baseline based on compatibility to the third edition standard package of AAMVANSI 60601-1 :2005 and its collateral and particular standards for intensive care ventilators. The submission does also include modifications of the software and hardware to update existing functionalities since the last submission (K073149). The SERVO-s ventilator system (here after called SERVO-s) is based on the SERVO-i ventilator family platform. SERVO-s ventilation system is a downscaled version based on the SERVO-i ventilator system notified in K041223. The SERVO-s Ventilator System is intended to provide continuous ventilation for neonate to adult patients in the weight range 2-250 kg and with tidal volumes from 10 mL to 2000 mL. The SERVO-s Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The ventilator delivers controlled or supported breaths to the patient, with either constant flow or constant pressure, using a set oxygen concentration. SERVO-s Ventilator System will produce visual and audible alarms if vital parameters vary beyond preset, or default, limits. The system contains two internal batteries to supply the system with power in the case of mains power failure or during inhospital transport. The ventilator functionality is controlled by software. The SERVO-s Ventilator System is available in two software versions, Infant and Adult. This 510(k) submission for the SERVO-s include changes to receive a new baseline based on compatibility to the third edition standard package of IEC 60601-1 :2005 and its collateral and particular standards for intensive care ventilators. The submission does also include addition of the Infant option, patient weight range 2-10 kg, with tidal volumes from 10 mL to 350 mL and modifications of the software and hardware to update existing functionalities.