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FAQ

Frequently Asked Questions

What is the most commonly used adhesive type?

“Mild is the most commonly used adhesive strength currently in the UK. This is mainly because the adhesive is gentle and more applicable for sensitive skin types. However, Standard adhesive is advisable for longer procedures where condensation build-up is more common; Standard is more porous and circumvents this issue.”

Box quantities or Unit of Measure?

“EyeGard is supplied in boxes of 50 pairs, whereas EyeGuardian is supplied in boxes of 100 pairs.”

How does the Vapor-Clean remove anesthetic vapors?

The Vapor-Clean filter canisters contain granules of medical grade activated charcoal.  Volatile anesthetic vapor molecules are captured and held by the activated charcoal granules.

Can the Vapor-Clean be reused?

No.  The Vapor-Clean is a single patient use device.  A new set of Vapor-Clean filters should be used for each patient.  At the conclusion of the anesthetic procedure, the Vapor-Clean filters should be discarded.

Can the Vapor-Clean be used if Malignant Hyperthermia (MH) is detected intra-operatively?

Yes. Installation of the Vapor-Clean intra-operatively removes residual anesthetic vapors emitted by the anesthesia gas machine as well as vapors emitted by the patient.  Placement of the Vapor-Clean at any time ensures that no vapor will be inhaled by the patient.

Does the Vapor-Clean work with all anesthetic gases?

Yes.  The Vapor-Clean has been tested and proven effective at removing >99% of isoflurane, sevoflurane and desflurane.

What is the shelf life of the Vapor-Clean?

The shelf life is a guaranteed minimum of two years.

How soon after installation of the Vapor-Clean is the anesthesia gas machine free of trace anesthetic vapors? 

Tests showed that the concentration of vapor was less than 5 parts per million in less than 2 minutes.

Why does the Vapor-Clean include two activated charcoal filters?

The primary reason for including two filters is to increase anesthetic gas removal in the intra-operative application.  Additionally, the dual filter prevents inhalation of vapor in case one of the anesthesia machine’s non-rebreathing valves fails.  An additional safety reason for the dual filter configuration is to minimize the possibility of inadvertent placement of a single charcoal filter  on only the expiration hose port.

Has the Vapor-Clean been cleared by the Food and Drug administration?

Yes.  The Vapor-Clean has been cleared by FDA for removal of unwanted anesthetic vapors.  The 510(k) clearance number is K092031.

During development, was the Vapor-Clean tested on actual malignant hyperthermia-susceptible patients?

No.  The Vapor-Clean was not tested on actual MH susceptible patients.  However, it has been demonstrated effective at removing >99% of anesthetic vapors in rigorous bench testing, and has been used successfully on many MH-susceptible patients worldwide since its introduction.

Which anesthesia gas machines require Vapor-Clean filters?

Published studies show that the newer Draeger anesthesia gas machines (Primus, Apollo, Fabius) and GE-Ohmeda (Aestiva) require 50-75 minutes of continuous gas flush at 10 L/min before residual vapor concentrations are less than the save level of 5 parts per million.  It is likely that other new machines that contain plastic parts require similar preparation times.

What is the source of residual anesthetic vapor in the anesthesia gas machine?

Plastic parts (valves, tubing, bellows, etc.) within the anesthesia gas machine absorb anesthetic vapor.  These absorbed gases are then slowly released when the machine is used for a new patient during a subsequent anesthetic procedure.

Does use of the Vapor-Clean during a MH case eliminate the need for dantrolene to be given?

No.  The Vapor-Clean only clears the anesthesia machine of trace anesthetic agents that can trigger MH.  Dantrolene is still required to treat the disease process of MH

The nose gets cold quickly. How can this site get a better signal than a finger?

The tip of the nose may get cold quickly, but the area where the Nasal Alar SpO2 Sensor is applied is at the side of the nares, close to the cheek. This area maintains excellent perfusion as it is supplied by the last branch of the external and the first branch of the internal carotid arteries – the internal carotid is the same vessel that supplies blood to the brain. This region of the nose is resistant to frostbite even when the ears and fingers are affected.

How is the sensor applied?

The Nasal Alar SpO2 Sensor sensor comes packaged with an applicator that makes it very easy to apply. Simply squeeze the applicator to open the sensor and slip over the fleshy area at the side of the nose – either side. Release the squeeze on the applicator and slide out to remove. The sensor may have to be pushed further onto the ala after removal of the applicator. The sensor is held in place by a small clip with soft cushions that apply minimal pressure on the tissue, but holds it securely without any adhesive.

Is there any skin prep required? What if there is lotion on the nose or the area is greasy?

There is no prep required as there is no adhesive used. However, for optimal performance, sunscreens, foundations, and powders should be removed from the side of the nose prior to use by degreasing according to the practice in your facility.

Does the sensor squeeze the nose?

The sensor was designed paying specific attention to the applied pressure. The cushions encapsulating the optical components are molded in a soft, medical grade silicone with smooth skin contacting surfaces. These smooth surfaces provide a high coefficient of friction, allowing the sensor to stay in place with minimal pressure, and without the use of adhesives. The light pressures allow for the use of a very flexible plastic clip with thin cross sections. It is very lightweight to further enhance patient comfort.

How about the wire coming off the sensor? How is that managed?

The sensor wire is very thin and lightweight and will not pull on the sensor. It can be looped over the patient’s ear (like a nasal cannula) to keep it out of the way. The wire can be secured to the cheek with tape and this is recommended when the sensor wire is looped over the patient’s ear.

It seems uncomfortable to have something on your nose?

The Nasal Alar SpO2 Sensor is actually very comfortable to wear and becomes “invisible” to the patient. The sensor applies minimal pressure on the tissue and can be worn for extended periods of time. And, the hands are free for normal patient functions like eating, drinking, sleeping or talking.  The nasal alar sensor was validated in a usability study for 7-days of continuous use and was preferred by study participants over the finger sensor.

What if the patient has a nasal oxygen cannula?

The Nasal Alar SpO2 Sensor will not interfere with the nasal cannula. And the oxygen supply will not affect the sensor’s ability to determine a reliable measurement.

What if the patient has a mask?

The flex cable from the sensor is paper thin and can pass under a mask without affecting the seal. If used with heated humidification through a mask, the sensor should be used for no longer than 24 hours and the site checked frequently.

How long can the sensor be left in place?

Because it uses no adhesive on the nasal ala, the Nasal Alar SpO2 Sensor can be used for the patient’s entire length of stay. We recommend that the sensor site be inspected at least every 8 hours and the application site changed as necessary if circulation or skin integrity is compromised. During low perfusion, the sensor site needs to be assessed frequently for signs of tissue ischemia, which can lead to pressure necrosis. Persons with pre-existing skin conditions may be more susceptible to tissue damage.

Can I clean and re-use the sensor?

The Nasal Alar SpO2 Sensor is a disposable, single patient use device. The device cannot be cleaned or sterilized without potential damage to critical components. Re-use may cause unreliable readings and, if the sensor is used on more than one patient, there is a risk of cross contamination.

What monitors will work with the Nasal SpO2 Sensor?

The Nasal Alar SpO2 Sensor is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.

For what purpose and for whom is Monidrop® intended?

Monidrop® is designed for the basic IV therapy in hospital wards and for home health care.

What liquids can be used when using Monidrop®?

Antibiotics, general purpose IV solutions, blood products, and regular nutrients.

Can Monidrop be cleaned using the normal cleaning liquid chemicals?

Monidrop® can be cleaned and disinfected using the regular medical device cleaning methods and chemicals. For more information, please see the user manual.

How is the infusion flow rate adjusted?

Flow rate is adjusted by using the clamp, and the infusion speed can be seen on the screen (ml/h). Monidrop® monitors the infusion but does not adjust it.

Can Monidrop be used for the same purpose as a syringe pump?

Monidrop® is designed to improve the quality of care in infusion therapy that is often conducted manually without the assistance of any electronic device.

Does Monidrop® require a device-specific IV infusion set?

Monidrop® is compatible with the most commonly used drip sets with 20 drops/ml. It can be quickly fastened on to the drip chamber.

What kinds of alarms can be set?

The user can set alarm limits for the target infusion speed (ml/h), total volume (ml), or elapsed time. In case of alarm, Monidrop® indicates alarms with LED lights and sounds. The alarm can also be set to silent mode, e.g. during night time.

How do the alarms work?

An audio alarm will be given for medium level alarms. The alarm light will display a yellow LED light, indicating a low priority alarm, and a blinking yellow light indicates a medium priority alarm. If there are no alarms, the LED light is green.
Alarms are described in detail in the user manual. Alarms may occur due to the fact that the infusion speed deviates from the preset alarm limits or the infusion speed is outside the measurement range of 6ml/h…1200ml/h. Also, a low battery alarm will be given with a sound and a LED light.

How is Monidrop® charged and can it be used while charging?

The device can be charged with the device’s charger, which is included in the sales package. Monidrop® can be used while charging.

Does the device have wireless connectivity?

Wireless connectivity can be implemented to the hospital network as a separate feature.