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Anaesthetic Delivery System- Sedaconda® ACD is intended for administering isoflurane and sevoflurane to invasively ventilated patients. Administration of isoflurane and sevoflurane using Sedaconda® ACD should only be done in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of inhalational anaesthetic drugs and the recognition and management of the expected adverse effects of such drugs, including respiratory and cardiac resuscitation. Such training must include the establishment and maintenance of a patent airway and assisted ventilation. Sedaconda® ACD is intended for single use only and needs to be replaced every 24 hours or when needed e.g. at unexpected events such as sudden blockage of the airways because of secretion etc. The Sedaconda® ACD is available in Sedaconda® ACD 100 ml and Sedaconda® ACD 50 ml sizes. The instructions contained in this document apply to both devices. Sedaconda® ACD for Small Tidal Volumes and the connection of the Sedaconda® ACD to the inspiratory port of the ventilator. This placement is intended for and enables the delivery of inhaled anaesthetics to patients with tidal volumes of 30 - India CDSCO Medical Device Registration

Anaesthetic Delivery System- Sedaconda® ACD is intended for administering isoflurane and sevoflurane to invasively ventilated patients. Administration of isoflurane and sevoflurane using Sedaconda® ACD should only be done in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of inhalational anaesthetic drugs and the recognition and management of the expected adverse effects of such drugs, including respiratory and cardiac resuscitation. Such training must include the establishment and maintenance of a patent airway and assisted ventilation. Sedaconda® ACD is intended for single use only and needs to be replaced every 24 hours or when needed e.g. at unexpected events such as sudden blockage of the airways because of secretion etc. The Sedaconda® ACD is available in Sedaconda® ACD 100 ml and Sedaconda® ACD 50 ml sizes. The instructions contained in this document apply to both devices. Sedaconda® ACD for Small Tidal Volumes and the connection of the Sedaconda® ACD to the inspiratory port of the ventilator. This placement is intended for and enables the delivery of inhaled anaesthetics to patients with tidal volumes of 30 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001172_b417194a3a888b4453d0113c176b1194_0afa972064a65f47f3f707ecfd7d3045. This device is marketed under the brand name Sedaconda®. The license holder is M/s. Hansraj Nayyar Medical India, and it is classified as Device Class Class C. The approving authority is CDSCO.

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Class Class C
Anaesthetic Delivery System- Sedaconda® ACD is intended for administering isoflurane and sevoflurane to invasively ventilated patients. Administration of isoflurane and sevoflurane using Sedaconda® ACD should only be done in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of inhalational anaesthetic drugs and the recognition and management of the expected adverse effects of such drugs, including respiratory and cardiac resuscitation. Such training must include the establishment and maintenance of a patent airway and assisted ventilation. Sedaconda® ACD is intended for single use only and needs to be replaced every 24 hours or when needed e.g. at unexpected events such as sudden blockage of the airways because of secretion etc. The Sedaconda® ACD is available in Sedaconda® ACD 100 ml and Sedaconda® ACD 50 ml sizes. The instructions contained in this document apply to both devices. Sedaconda® ACD for Small Tidal Volumes and the connection of the Sedaconda® ACD to the inspiratory port of the ventilator. This placement is intended for and enables the delivery of inhaled anaesthetics to patients with tidal volumes of 30
UID: IMP/MD/2023/001172_b417194a3a888b4453d0113c176b1194_0afa972064a65f47f3f707ecfd7d3045

Brand Name

Sedaconda®

Device Class

Class C

Approving Authority

CDSCO

Product Information

200 ml. The advantage of the inspiratory side placement is that no dead space is added to the breathing circuit. In contrast to the standard placement of the Sedaconda® ACD (Sedaconda®) the inspiratory side placement only utilises the evaporator function of the Sedaconda® ACD and there is no reflection of inhaled anaesthetic. Therefore, higher inhaled anaesthetic pump rates can be expected than with standard placement, despite lower tidal volumes. Administration of isoflurane and sevoflurane using Sedaconda® ACD should only be done in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of inhalational anaesthetic drugs and the recognition and management of the expected adverse effects of such drugs, including respiratory and cardiac resuscitation. Such training must include the establishment and maintenance of a patient airway and assisted ventilation.

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