Search Results
Found 1 results
510(k) Data Aggregation
K Number
K230931Device Name
Atlan
Manufacturer
Drägerwerk AG Co. KGaA
Date Cleared
2023-07-23
(111 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
Drägerwerk AG Co. KGaA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
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 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
Ask a Question
Page 1 of 1