Resources

What standards does MOVES® SLC™ comply with?
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
BS EN 794-3: Lung Ventilators – Particular requirements for emergency and transport ventilators
What roadworthiness and air worthiness standards does the system comply with?
- MOVES® SLC™ was evaluated for roadworthiness through testing to standard BS EN 794-3 (lung ventilators – particular requirements for emergency and transport ventilators).
- 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- 810G.
How many physiological readings/traces does MOVES display on the screen at once?
MOVES® SLC™ concurrently displays SpO2, Heart Rate, PetCO2, PiCO2, FiO2, Respiratory Rate, NIBP, Patient Temperature (2 channels), Invasive Blood Pressure (3 channels), ventilator parameters PIP, PEEP and Vte, oxygen concentrator flow rate and suction pressure, when suction is activated.
Two real-time charts or trends can be concurrently displayed on the MAIN screen as well:
- 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™ also has a dedicated ECG screen that, when selected, displays all 12 ECG leads simultaneously.
Furthermore, an optional, separate, Remote Screen Interface tablet can be connected to the MOVES® SLC™. The Remote Screen Interface can be used to fully control the MOVES® SLC™, and allows for the display of two real-time charts or trends (as described above) in addition to those displayed on the device’s embedded user interface, or the navigation to other device screens (for example, the ECG screen) while maintaining display of the MAIN screen on the device’s embedded user interface (or vice-versa).
Is MOVES® SLC™ capable of Invasive Blood Pressure monitoring and how many channels?
- 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).
Is MOVES® SLC™ suitable for use on paediatric and neonate patients? Does it come with suitable accessories and attachments for these patients?
- 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.
What is the operator adjustable tidal volume range for the ventilator in mL?
When operated in a volume control ventilation mode, the operator adjustable tidal volume range is 50 mL to 750 mL.
What is the operator adjustable FiO2 concentration range for the ventilator in percentage?
The operator adjustable FiO2 range, when ventilating, is AIR (21%), 30%, 40%, 50%, 60%, 70%, 85%, MAXIMUM (~93%), which is achieved as follows:
- Integrated Air Pump: AIR (21%)
- Integrated Oxygen Concentrator: 30%, 40%, 50%, 60%, 70%, 85%, MAXIMUM (~93%)
- External, flow-controlled oxygen, supplied at less than 2.5 LPM, can be connected to MOVES® SLC™ to provide an FiO2 up to 99%
How many physiological readings/traces does MOVES display on the screen at once?
MOVES® SLC™ concurrently displays SpO2, Heart Rate, PetCO2, PiCO2, FiO2, Respiratory Rate, NIBP, Patient Temperature (2 channels), Invasive Blood Pressure (3 channels), ventilator parameters PIP, PEEP and Vte, oxygen concentrator flow rate and suction pressure, when suction is activated.
Two real-time charts or trends can be concurrently displayed on the MAIN screen as well:
• 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™ also has a dedicated ECG screen that, when selected, displays all 12 ECG leads simultaneously.
Furthermore, an optional, separate, Remote Screen Interface tablet can be connected to the MOVES® SLC™. The Remote Screen Interface can be used to fully control the MOVES® SLC™, and allows for the display of two real-time charts or trends (as described above) in addition to those displayed on the device’s embedded user interface, or the navigation to other device screens (for example, the ECG screen) while maintaining display of the MAIN screen on the device’s embedded user interface (or vice-versa).
Does the ventilator automatically adjust the delivered flow to compensate for variable leaks?
Yes
Does MOVES® SLC™ compensate for altitude? And how?
- 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
What is the flow rate of oxygen in the ventilator? Range?
- 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 approximately 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.
- For further information on circle-circuits and anesthesia conservation, click here.
What is the operator adjustable inspiratory flow rate in LPM?
- 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.
Does the system provide an oxygen flush capability?
- 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
What pressure and flow rate does the system provide negative pressure suction?
The suction pressure is adjustable from 100 mmHg to 325 mmHg, with a flow rate of 20 LPM.
Is the suction system suitable for oropharyngeal and tracheal aspiration?
Yes.
Does the suction system have a continuous and intermittent vacuum mode?
The integrated suction function of the MOVES® SLC™ can be operated both continuously and intermittently.
What is the suction flow rate?
The suction flow rate is 20 LPM.
How long does it take the system to reach a vacuum level of 300 mmHg?
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.
What is the volume of the suction canister provided?
The suction canister provided with the MOVES® SLC™ has a volume of 800 mL
Does the system come with autoclavable suction canisters & disposable liners or disposable suction canisters?
MOVES® SLC™ is provided with disposable suction canisters but can be used or provided with any kind of suction canister (such as those with disposable liners, etc.).
Can the system be connected to multiple suction canisters at one time?
Yes
Does the suction canister/suction system prevent overflow of aspirated material?
Yes, the suction canister provided with the system prevents overflow of aspirated material.
Does the system provide airway humidification?
- 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.
If so, what temperature does it warm the air to for invasive & non- invasive ventilation?
Natural humidification and heating of the inspired respiratory gas, as described above, results in respiratory gas that is maintained at body temperature.
If so, what flow rates of oxygen and air for invasive and non-invasive ventilation (LPM)?
Natural humidification and heating of the inspired respiratory gas, as described above, is independent of ventilatory gas flow.
Does MOVES® SLC™ have defibrillation capability?
- 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™.
How is CO removed from the body?
- Carbon monoxide (CO) is more attracted to hemoglobin than oxygen (O2).
- Only small concentrations of CO are required to result in many attachment sites on hemoglobin being replaced by CO.
- When exposure to CO is stopped, CO is slowly replaced by O2 from air, which is 21% O2. 4. By increasing O2 concentration by 5 times to 100% O2, the rate of replacement of CO by O2 increases by 5 times that of room air.
What is the mechanism for hyperbaric chamber treatment of CO poisoning?
- By increasing the pressure of O2 by 3 times, as occurs in hyperbaric chamber, there are 3 times more O2 molecules in the same volume present and the rate of replacement of CO will increase again by 3 times.
- This means that in the hyperbaric chamber the replacement of CO is 3 times as fast as just giving 100% O2.
- Since giving 100% O2 replaces CO 5 times as fast as room air, the hyperbaric chamber results in CO elimination that is 3 x 5 = 15 times as fast as room air.
What is the mechanism for ClearMate™ treatment of CO poisoning?
- As the blood passes by the lung, CO diffuses into the lung.
- Breathing 100% O2 causes the CO to diffuse into the lung 5 times as fast as breathing room air (21% O2)
- Increasing the breathing rate by 3 times resting breathing, the lungs, and therefore the blood, are cleared of CO 3 times as fast.
- This increased rate of elimination is on top of the 5 times increase in the rate of CO elimination from breathing pure O2.
- As such, increasing ventilation by 3 times with ClearMate™ results in the elimination of CO by 3 x 5 = 15 times that on room air – same as the hyperbaric chamber.
Does this work even at high blood concentrations of CO?
- The rates of elimination of CO were studied in dogs (Fisher et al., 1999) which were poisoned to 70% carboxyhemoglobin, which is near the fatal level for dogs and humans.
- The animals were treated in the hyperbaric chamber as well as with ClearMate™.
- The rates of elimination of CO were the same with ClearMate™ as with hyperbaric O2.
Does this work in humans?
- Humans were exposed to CO and then the rates of elimination of CO were examined while breathing O2 at different rates of ventilation (extents of breathing). (Takeuchi et al., 2000).
- The rates of elimination of CO were found to increase with increased ventilation.
- The optimal rate of elimination occurred at about 3 times resting breathing. This is about the breathing rate of healthy people after walking up one or two fights of stairs.
- So, yes, it works in humans.
So, should we just ask humans to hyperventilate?
- It is a common experience that people cannot hyperventilate for long as they become light headed and uncomfortable.
- This is because hyperventilation also eliminates carbon dioxide from the blood.
- Hyperventilation and loss of carbon dioxide is bad for the patient.
So, how do we arrange to eliminate CO and not carbon dioxide? Are there carbon dioxide sensors, flow sensors and feed-back loops?
- We have designed ClearMate™ to replace the carbon dioxide in exact proportion that it is being lost so the carbon dioxide level in the blood stays the same regardless of how hard the patient breathes.
- There are no carbon dioxide sensors or flow meters or any other electronics.
- ClearMate™ is a simple mechanical device that contains some standard valves that passively and automatically replaces exactly the amount of carbon dioxide that is lost, regardless of the extent and pattern of breathing.
- Because the carbon dioxide replacement is locked in mechanically, the system is perfect and cannot be fooled.
How do you get the patients to hyperventilate? What if they won’t cooperate?
- Patients who are breathing spontaneously on the ClearMate™ circuit will automatically hyperventilate by the following mechanism:
- They get 100% O2. Contrary to what most people think, O2 is a respiratory stimulant, NOT a respiratory depressant. Those who need some convincing may review the following references: (Rucker et al., 2002; Iscoe & Fisher, 2005; Becker et al., 1995; Becker et al., 1996).
- The ClearMate™ can be used to control the carbon dioxide in the blood. The user can use the ClearMate™ to slightly increase the carbon dioxide level which also stimulates ventilation.
If there is a hyperbaric chamber available, do I still need a ClearMate™?
- The efficacy of treatment of CO poisoning depends very much on the time to treatment, especially for pregnant patients.
- The hyperbaric chamber typically takes at least 2 hours to prepare.
- ClearMate™ is portable and treatment can be started right at the time of rescue and continued in the ambulance.
- Even if it takes only 20 minutes to pick up the patient and arrive at the hospital, in that 20 minutes the CO level would fall to half.
- In an hour, the CO levels may be too low to detect. This is an advantage in places that don’t have hyperbaric chambers.
- Treatment with ClearMate™ does not prevent or delay treatment with a hyperbaric chamber, if one is available.
What advantages are there to using the ClearMate™? Why isn’t giving them 100% O2 good enough?
- As discussed, 100% O2 increases the CO elimination by 5 times.
- With ClearMate™, this increase in elimination goes to 15 times.
- One would think that giving people 100% O2 must provide more O2 to the brain than just giving them air.
- However, when this is tested, it has been shown that administering O2 actually reduces the brain blood flow, and the net effect is less O2 delivered to the brain. (Rucker et al., 2002)
- If the O2 is administered with ClearMate™, the carbon dioxide levels are maintained and the O2 delivery to the brain is maintained. (Rucker & Fisher, 2006)
If this is true, the ClearMate™ should be able to increase the elimination from the blood of any volatile substance. Has this been tested?
- Yes. Anesthetics are volatile hydrocarbons. With ClearMate™, anesthetics are quickly cleared and patients wake up quickly. (Katznelson et al., 2008;Katznelson et al., 2010;Katznelson et al., 2011)
Is the ClearMate™ as safe as hyperbaric oxygen?
- Safer.
- There is no foreseeable harm to increased ventilation at normal carbon dioxide in almost anyone – certainly when compared to risk of continued exposure of tissues to CO.
- Complications from hyperbaric chambers can include ruptured ear drums, trauma to sinuses, seizures, strokes from decompression, and others
What is the cost comparison?
- Hyperbaric chambers require large capital outlay for the equipment and infrastructure, and have large maintenance requirements.
- ClearMate™ costs an order of magnitude less to purchase and requires no infrastructure to maintain. Its consumables are few and inexpensive.
If it’s so simple, effective and inexpensive, why has it taken so long to become available?
- The historical reason for this is given in a recent publication (Fisher et al., 2011). The abstract from this publication is reproduced below:
- “At the start of the 20th century, CO poisoning was treated by administering a combination of CO2 and O2 (carbogen) to stimulate ventilation. This treatment was reported to be highly effective, even reversing the deep coma of severe CO poisoning before patients arrived at the hospital. The efficacy of carbogen in treating CO poisoning was initially attributed to the absorption of CO2; however, it was eventually realized that the increase in pulmonary ventilation was the predominant factor accelerating clearance of CO from the blood. The inhaled CO2 in the carbogen stimulated ventilation but prevented hypocapnia and the resulting reductions in cerebral blood flow. By then, however, carbogen treatment for CO poisoning had been abandoned in favour of hyperbaric O2. Now, a half-century later, there is accumulating evidence that hyperbaric O2 is not efficacious, most probably because of delays in initiating treatment. We now also know that increases in pulmonary ventilation with O2-enriched gas can clear CO from the blood as fast, or very nearly as fast, as hyperbaric O2. Compared with hyperbaric O2, the technology for accelerating pulmonary clearance of CO with hyperoxic gas is not only portable and inexpensive, but also may be far more effective because treatment can be initiated sooner. In addition, the technology can be distributed more widely, especially in developing countries where the prevalence of CO poisoning is highest. Finally, early pulmonary CO clearance does not delay or preclude any other treatment, including subsequent treatment with hyperbaric O2.”
What is the mechanism for hyperbaric chamber treatment of CO poisoning?
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How is CO removed from the body?
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WENQING WU, YUNYU MA, FANG JIANG
A Clinical Study of Treatment for Delayed Neuropsychoneural Sequela Caused by Acute CO Poisoning with ClearMate™ Gas Poisoning First Aid Ventilator
Translated from original text: Chinese Journal of Clinicians (Electronic Edition), January 2015, Vol 12.24, No. 12
Joseph A. Fisher, Lashmi Venkatraghavan and David J. Mikulis
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Neuroimaging Assessment of Cerebrovascular Reactivity in Concussion: Current Concepts, Methodological Considerations, and Review of the Literature
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Assessment of Myocardial Reactivity to Controlled Hypercapnia with Free-breathing T2-prepared Cardiac Blood Oxygen Level–Dependent MR Imaging
Published Online: Apr 17 2014 https://doi.org/10.1148/radiol.14132549
Poublanc J, Crawley AP, Sobczyk O, Montandon G, Sam K, Mandell DM, Dufort P, Venkatraghavan L, Duffin J, Mikulis DJ, Fisher JA.
Measuring cerebrovascular reactivity: the dynamic response to a step hypercapnic stimulus.
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Identifying Significant Changes in Cerebrovascular Reactivity to Carbon Dioxide.
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