Gradian Comprehensive Care Ventilator (CCV)
Gradian Health Systems
The Gradian CCV is a mechanical ventilation system meant for use in low-oxygen and electricity settings.
The Gradian Comprehensive Care Ventilator (CCV) is a mechanical ventilation system. It is meant to be used for critically ill patients in hospital settings and has a battery life of up to 21-hours. The machine is portable and features an internal air compressor.
This product was selected for inclusion in WHO’s 2021 Compendium of Innovative Health Technologies for Low‐Resource Settings.
The product is distributed by the manufacturer. There are also distributors in several countries around the world: Homintec (Benin, Togo), Meditek SARL (Burkina Faso), HeiDoctor (Ghana), Labonet (Guinea), Avoma Group (Mozambique, Swaziland), Biomedical Engineering Foundation of Nepal (Nepal), Artemis Life (Nigeria), Medical Engineering Solutions, Ltd (Rwanda), Medical Equipment Management Systems (Sierra Leone), Kas Medics, Ltd (Tanzania), Joint Medical Store (Uganda), Sonergy Diagnostics, Ltd (Zambia).
Contact Gradian for pricing information.
Goal 3: Good health and well-being
Critically-ill patients, from infant/paediatric to adult (>5 kg).
As of December 2019, over 200 units have been distributed. Due to the COVID-19 epidemic the distributions have likely increased.
Type of ventilator as defined by WHO specifications and the patient group that can use the device as specified by the manufacturer (weight in kg if specified).
Does the ventilator display PEEP, Peak Pressure, Tidal Volume, Ventilator Mode Indicatory Status?
Are the following main alarms available: High/low FiO, high/low minute volume (MV), high/low inspiratory pressure, breathing circuit disconnect, apnoea, gas supply failure, power failure, low battery?
Is the air source external or internal? If internal, what technology is used to provide the air source? Does the ventilator have O2 low pressure capability?
The Gradian CCV is a ventilator meant for use in a variety of situations. In short, the product consists of the central control system with various accessories for ease of use. The product has a 7-hour battery life and comes with a battery pack that can add up to 14 hours of battery life, giving a total of 21 hours of battery life. There is a hook on the central control system that allows the system to be hung, and the product also has a rolling stand for ease of transport. The user interface consists of several digital displays. There is an internal air compressor that can be used when external sources are not accessible. There is also an oxygen reservoir that can be used with an oxygen concentrator or flowmeter if a pipeline or cylinders are unavailable. The system allows the operator to pre-program custom ventilation mode settings for specific disease conditions.
The product dimensions are: 34 x 13 x 35 cm. The system weight is 8.5 kg. The product has an ABS casing and has ingress protection compliant with IP22 and has a reusable silicone breathing circuit.
Provided by the manufacturer. Each country with a product distributor has a team of biomedical engineers and technicians that are available to provide technical support.
The particle filter should be checked every 3 months and replaced if visibly dirty. Batteries should be replaced every 3 years. HME (heat and moisture exchanger) filters should be discarded between patients.
The lifetime of the product is 6+ years and requires comprehensive maintenance after 6 years to ensure proper function and safety. The product comes with a 3 year warranty which covers remote support, yearly preventative maintenance, and repairs of non-consumable parts due to manufacturing defects.
Manufacturer specified performance targets include: multi-environment use, broad-featured capability, ease of use, low cost ownership, and reliable and local customer support.
U.S. FDA, D.L.S. Electronic Systems, Inc., Toxikon Corporation, Garwood Laboratories: An NTS Company, and Aegis Labs, Inc.
The CCV User Guide offers substantial information regarding the safety of the product and should be consulted for a complete understanding of the necessary safety precautions.
The product requires a reliable power source to for battery recharging. An alternate means of ventilation should be available while using the CCV in case of a mechanical or system problem.
A. O. Ademuyiwa et al., 2020 COVID-19 Preparedness within the Surgical, Obstetric and Anesthetic Ecosystem in Sub Saharan Africa, Ann. Surg., 272(1):e9-e13.
M. Shahid, 2019 Prototyping of artificial respiration machine using AMBU bag compression, in ICEIC 2019 – International Conference on Electronics, Information, and Communication, pp. 1-6.
Winner of the Saving Lives at Birth Award to improve maternal and newborn healthcare in Zambia.
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