Gradian Health Systems Universal Anaesthesia Machine

Target SDGs

Market Suggested Retail Price

$19,900.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

Gradian Health Systems, Homintec, Meditek SARL, Labonet, Mediquip Global, Afritool, MEMS, KAS Medics, Joint Medical Stores, Sonergy Diagnostics, all listed on the website with relevant contact information.

Manufacturing/Building Method

Mass produced in an ISO-certified factory. Manufacturing partner is OES Medical.

Intellectural Property Type

Patent

User Provision Model

As of August 2020, a quote can be requested on the Gradian Health website. Health centres can obtain a UAM through the many distributors partnered with Gradian Health.

Distributions to Date Status

700+ operating rooms are equipped with this system.

Design Specifications

The Universal Anaesthesia Machine (UAM) delivers safe anaesthesia in any hospital, including those where unreliable electricity and shortages of compressed medical gases preclude the use of conventional machines. Its combination of continuous flow and draw-over anaesthesia qualifies it for use in facilities from world-renown hospitals to resource-constrained district hospitals in low-income countries. The optional ventilator provides electrically-driven automatic ventilation in volume and pressure control modes, and will operate without mains power for up to 6 hours on rechargeable battery power. A video demonstration of the device is available on the Gradian Health website. Design Specifications Physical And Electrical: - - Dimensions: 146cm x 53cm x 69cm; 130kg - - Aluminum frame with vertical dove mount side rails - - Mains power supply: 240V, 50-60Hz - - Oxygen monitor power: CE-marked, fused, medical grade Isolator and surge protected components & sockets - - 3.5” touch screen for oxygen monitor & alarms - - Front lockable castors Oxygen Supply And Monitoring: - - Integrated oxygen concentrator with dual filters - - O2 flow rate: 0.1 to 10 liters per minute - - Maximum O2 concentration: 95% - - Maximum concentration available at all flow rates - - Alternative O2 sources: cylinder, pipeline or portable - - Multi-diameter hose connector for portable O2 - source Permits adjustment of air /oxygen mixture - - Room air intake when minute volume > fresh gas flow Glass flow meter accurate to +/- 2.5% at 100% O2 Integrated, calibrated inspiratory oxygen monitoring Pressure sensitive apnea alarm - - Adjustable minimum and maximum O2 alarm settings - - Ten hour battery backup, trickle charge from mains power Optional Use Of Nitrous Oxide: - - Pipeline or cylinder sources - - N2O automatically shut off if O2 falls below 25% Differentiated flow control knob - - Independent glass flow meter accurate to +/- 2.5% Ventilation: - - Unique bellows for adult and pediatric ventilation Made from durable, long-lasting silicone rubber 1600cc capacity - - Inspiratory pressure relief valve at 55cm water Silicone inflating balloon valve at the expiratory port Standard adult and pediatric breathing systems - - - - Accepts standard scavenging devices Vaporizers: - - Stainless steel and plated brass construction - - Separate units for isoflurane and halothane - - Seamless transition from continuous to draw-over mode 120ml capacity Rear Panel Connector: - - Mains isolator switch - - 2 UK style power sockets - - Oxygen and nitrous pipeline - - Cylinder connectors Multi-diameter external oxygen hose connector  

Product Schematics

Technical Support

Gradian Health Systems trains local biomedical technicians to perform first line service. They also offer internet and phone support, spare parts by courier shipment and regional service providers. Whenever Gradian Health installs a machine, they provide a complimentary, on-site product training for the hospital’s clinical and technical staff. Customer support and training materials can be found in the customer support. The warranty lasts two years. Gradian Health provides two preventative maintenance checks per year, an inventory of locally stored spare parts, unlimited repairs, 24/7 customer service and troubleshooting via email, phone, and Whatsapp, and a suite of technical resources available in multiple file formats and languages.

Replacement Components

Gradian Health Systems provides courier delivery of spare parts and regional service representatives.

Lifecycle

Two year warranty

Manufacturer Specified Performance Parameters

A built-in oxygen concentrator produces up to 10 liters per minute of 95% oxygen. If power and compressed gas are unavailable, the UAM automatically converts to draw-over mode, continually delivering consistent anesthesia.

Vetted Performance Status

According to the Gradian Health website, after performing approximately 23,000 cases using the early product versions in Malawi, and validated by the first 2,000 patients in the UK and Nepal, the UAM proved to be safe, effective and rugged and earned CE certification. Recognizing that the UAM could have an impact wherever hospitals have insufficient resources and fragile infrastructure, Gradian Health Systems was launched in 2010 to introduce the UAM worldwide and provide training and service support to users. "The Universal Anaesthesia Machine was found to be reliable, safe and consistent across a range of tests during targeted functional testing" according to Anesthesia Journal, on a study conducted at a range of hospitals in the U.K.

Safety

Surgery and anaesthesia can be inherently dangerous. Gradian Health addresses this in many categories within their website. First, the oxygen monitor continuously displays inspired oxygen content. If using nitrous oxide, the system automatically disables N2O gas flow if a hypoxic mixture is detected. The oxygen monitor lasts up to ten hours on battery backup during power outages. The ventilator offers alarms for disconnect, high pressure, apnoea and other conditions. Next, the UAM operates with or without electricity and compressed gas. The integrated oxygen concentrator produces up to 10 liters per minute of 95% oxygen. If power is lost and no other source of oxygen is available the UAM converts automatically to draw-over mode using room air. The bellows allows assisted breathing in all situations. The electric ventilator works without compressed gas and up to six hours on battery backup during mains failures.

Complementary Technical Systems

The UAM Ventilator is an optional complementary component that provides electrically-driven automatic ventilation in volume and pressure control modes.

Academic Research and References

Compliance with regulations

The UAM is CE-certified and manufactured in an ISO-qualified factory.

Evaluation methods

The UAM was clinically evaluated for pediatric use in a 200 patient study at the Royal Hospital for Children. Patients ranged from 34 weeks to 16 years in age, and 1.6 to 82kg in weight. Patient complications were limited to three cases of post-extubation laryngospasm.

Other Information

Winner of the USAID's Saving Lives at Birth program grant.