MADM™ is a portable inline direct injection gas anesthesia vaporizer, capable of delivering isoflurane (ISO) and sevoflurane (SEVO) gas anesthesia safely and accurately using any source of ventilation in both controlled and challenging environments over a broad operating temperature range. MADM™ integrates the functions of gas anesthesia delivery and respiratory gas monitoring, and automatically adapts its operation to the type of ventilator it is connected to.
The versatility and portability of MADM™ make it ideal in more challenging environments such as field hospitals and forward-deployed surgical operations. MADM™ is quick to set up, easy to use, and has a small footprint – exactly what is required when time and space are at a premium, and mobility is required.
MADM™ is very economical in its consumption of liquid anesthetic, and automatically adapts its operation to the type of ventilator it is connected to. In a circle-circuit configuration, MADM™ automatically reduces its vaporization rate to compensate for unused anesthetic returning from the patient, resulting in a substantial reduction in liquid anesthetic consumption.
In the spring of 2019, MADM™ was used by NATO forces in Djibouti, Africa, on an evaluation basis in their forward-deployed on-base operating room. Quick to setup and easy to use, military medical personnel were operational within minutes, and identified MADM™ as providing both a simple and effective way to provide gas anesthesia both within the controlled environment of a standard operating theater, and beyond, in more challenging environments.
MADM™ has undergone real and simulated life-cycle testing to confirm reliability in various extreme use environments. It has also been evaluated for field use by the United States Army Aeromedical Research Laboratory (USAARL) and Air Force Medical Evaluation Support Activity (AFMESA). MADM™ functionality has also been tested to confirm it meets the relevant FDA and international standards for electronic medical devices for its specific functionality.
MADM™ is intended to deliver volatile anesthetic to a patient when placed in either circle or open anesthetic circuits. It vaporizes isoflurane and sevoflurane and delivers the vaporized anesthetic agent into the inspiratory limb of the breathing circuit.
MADM™ is also intended to monitor respiratory rate, CO2, and the anesthetic gases isoflurane and sevoflurane. It is intended to be connected to a patient breathing circuit for monitoring of patients to whom it is delivering volatile anesthetic gases. MADM™ is not indicated for use with a carrier gas containing nitrous oxide.
MADM™ is intended to be operated in hospitals. MADM™ is not intended to be used during patient transport.
The intended patient population is adults who weigh 40 kg (88 lbs) or more.
MADM™ is subject to any contraindication to inhaled anesthetics.
MADM™ is intended to be used by:
• Trained physicians
• Anesthesiologists
MADM™ is intended to be used for the duration of anesthetic delivery.
US Federal law restricts this device to sale by or on the order of a licensed medical practitioner.
• Isoflurane: 0 – 3.5%
• Sevoflurane: 0 – 5%
Agent Selection / Anesthetic
Concentration Delivered / End Tidal
Anesthetic Concentration / RR / PICO2 / PETCO2 / VE
3 kg (7 lbs.) – includes power supply
20 cm (8”) L x 13 cm (5”) W x 18 cm (7”) H
-20 °C to 50 °C (-4 °F to 122 °F)
10 °C to 40 °C (50 °F to 104 °F)
15% – 95% RH non-condensing Altitude: 0 – 3.0 km (10,000 ft.)
100-240 VAC 50/60 Hz + internal battery safety backup + optional standalone hot-swap battery base power supply.
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-8
ISO 80601-2-13
IEC 80601-2-55
ISO 5360
