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MOVES® SLC™ complies with several internationally recognized standards based on the functions it integrates, as detailed below:
- ISO 14971: Standard for the application of risk management to medical devices
- IEC/EN 60601-1: Medical Electrical Equipment – General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical Electrical Equipment – Part 1-2: General requirements for safety (Collateral standard: Electromagnetic compatibility requirements and tests)
- IEC 60601-1-8: Medical Electrical Equipment – Part 1-8: General requirements for safety
(Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems)
- ISO 80601-2-12: Medical Electrical Equipment – Part 2-12: Particular requirements for basic
safety and essential performance of critical care ventilators
- IEC 60601-2-27: Medical Electrical Equipment – Part 2: Particular requirements for the
safety, including essential performance, of electrocardiographic monitoring equipment
- IEC 80601-2-30: Medical Electrical Equipment – Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
- IEC 60601-2-34: Medical Electrical Equipment – Part 2: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
- IEC 60601-2-49: Medical Electrical Equipment – Part 2-49: Particular requirements for the
safety of multifunction patient monitoring equipment
- IEC 62304: Medical Device Software – Software life cycle processes
- ISO 8359: Oxygen Concentrators for Medical Use – Safety requirements
- ASTM E1112-00: Specification for electronic thermometer for intermittent
determination of patient temperature
- MOVES® SLC™ was also evaluated for roadworthiness and airworthiness by the United Stated Army Aeromedical Research Laboratory (USAARL) through testing to the Joint Enroute Care Equipment Test Standard (JECETS) and standard MIL-STD-810H.
- Real-Time Charts: ECG (all 12 leads individually), Invasive Blood Pressure (channels 1, 2 or 3), Plethysmograph (Pulse Oximetry), Airway Pressure and PCO2.
- Trends (at intervals of 30 minutes, 1, 2, 4, 8, 16 and 24 hours): FiO2 / SpO2, PetCO2, PIP, Patient Temperature (both TEMP1 and TEMP2 channels), HR, ABP (available under IP1, IP2, or IP3 channels), CVP (available under IP1, IP2, or IP3 channels), ICP (available under IP1, IP2, or IP3 channels), NIBP, SpO2, PI, SpCO, SpHb, SpMet, SpOC and PVI.
- MOVES® SLC™ has three invasive blood pressure channels, which can be independently configured to display arterial blood pressure (ABP), central venous pressure (CVP) or intracranial pressure (ICP).
- MOVES® SLC™ is intended for use with adult and paediatric patients who weigh between 10 kg and 120 kg.
- MOVES® SLC™ is provided with suitable accessories for paediatric patients, including paediatric non-invasive blood pressure (NIBP) arm cuffs and pulse oximeter finger clips, as well as consumable paediatric temperature probes and airway filters.
- MOVES® SLC™compensates for altitude up to 18,000 feet (5,486 meters).
- MOVES® SLC™ has three embedded, redundant barometric pressure sensors that continuously report their measurements to the ventilator (for flow and pressure compensation) and respiratory gas monitoring system
- Oxygen is provided to the MOVES® SLC™ ventilator by the integrated oxygen concentrator.
- The integrated oxygen concentrator, when running, provides product gas with an oxygen concentration of up to 93% at a flow rate of 2.5 LPM.
- MOVES® SLC™ is a circle-circuit (rebreather-type) ventilator, which captures and recycles the patient’s exhaled respiratory gas in order to greatly increase the efficiency of oxygen delivery, and as such, only low flow oxygen is required to provide the patient with a high FiO2.
- The inspiratory flow rate is not directly operator adjustable.
- The inspiratory flow rate is determined through ventilator settings such as respiratory rate, peak inspiratory pressure or tidal volume (depending on mode of control; pressure or volume), inspiratory-expiratory ratio or inspire time and so forth.
- When ventilating with MOVES® SLC™, the integrated oxygen concentrator can be set to run continuously (FiO2 set to MAXIMUM), providing oxygen flush at 2.5 LPM. Furthermore, flow-controlled oxygen from an external source can be connected to MOVES® SLC™ to provide oxygen flush at flow rates up to 15 LPM.
- MOVES® SLC™ does not have, or require, a high-pressure oxygen inlet connection and as such, cannot provide an oxygen flush at greater flow rates than indicated above.
Using the standard suction canister and tubing supplied with the MOVES® SLC™, a vacuum level of -300 mmHg is reached in less than 4 seconds after activation of suction.
- MOVES® SLC™ is a circle-circuit (rebreather-type) ventilator, which captures and recycles the patient’s exhaled respiratory gas in order to greatly increase the efficiency of oxygen delivery. As such, the patient’s inspired respiratory gas is naturally humidified by the patient as they rebreathe their exhaled respiratory gas.
- As well, the CO2 absorbent material found in the device’s Ventilator Cartridge (and required in the circle-circuit ventilator) becomes moist and warms to body temperature as it absorbs the patient’s exhaled CO2, which also provides humification to the inspired gas.
- It is noted that MOVES® SLC™ does not have a dedicated airway humidification function.
- Defibrillation is applied to treat cardiac dysrhythmias, sometimes caused by cardiac arrest. Defibrillation is not applied to patients without a detectable pulse or absent heart function. As such, in the battlefield or disaster environments, defibrillation is rarely useful and infrequently applied. The vast majority of patients requiring treatment have suffered some form of injury caused by physical trauma with the medical support vectored to “damage-control” or resuscitative surgery and life support capability to military personnel or others who have sustained traumatic injury.
- As such, MOVES® SLC™ does not have integrated defibrillator or the related pacer functionality. These trauma patients rarely require defibrillation, as cardiac-related issues in trauma patients generally originate from blood loss (hypovolemia). In an Intensive Care Unit (ICU), where the treatment of cardiac arrest and cardiac dysrhythmias is more prevalent than in a battlefield or disaster environment, there is typically, at most, a defibrillator available in a “crash-cart” type setup, which works as a perfect adjunct to MOVES® SLC™.