SUPPORT-FAQs

Our team of executives frequently undergo online and offline training workshops organized by the principal manufacturers to upgrade their knowledge and understanding of the products and the relative technology. Magal strongly believes that these training sessions go a long way in providing first-hand support to the clients and end-users. Our principals have a highly committed approach to customer support. Magal will pull all stops to ensure that even the slightest of difficulties encountered by the clients/ end-users are quickly and satisfactorily resolved; and where necessary, with an active intervention of the principal manufacturers.

Some frequently asked questions are briefly answered below:

Q?

Is the LMA™ device safe in the MRI environment?

A.

The LMA ProSeal™, LMA Classic™, and LMA Flexible™ and LMA Fastrach™ endotracheal tube are MR safe when properly positioned and secured with tape under the following conditions:

Shielded MRI system with static magnetic fields of 1.5 Tesla or less

Gradient magnetic fields of 20 Tesla/second or less, and

Maximum whole body averaged specific absorption rate [SAR] of 1.4 W/kg [1.1 W/kg for LMA-Fastrach™ endotracheal tube] for 30 minutes of imaging

If MRI is done in close proximity to the LMA Flexible™, LMA ProSeal™ or LMA Fastrach™ endotracheal tube, there will be distortion of the image in the area surrounding the airway due to the wire component of the airway tube

The LMA Unique™ has not been tested for MRI compatibility; however, its characteristics would be most similar to the LMA Classic™, as both of these LMA™ airways only have a small amount of metal within the valve in the pilot balloon

The LMA Fastrach™ is contraindicated for use with MRI

Q?

Can I use the LMA™ airways in laser surgery?

A.

The LMA Classic™, LMA Flexible™ and LMA Unique™ have been studied in vitro with various types of lasers and clinical reports have appeared in the literature; however, there are no recommendations for use of the LMA™airways in laser surgery.

Q?

What are the steps to be followed for inserting the LMA™ device?

A.

Some of the most common mistakes made while inserting the LMA™ airway include:

Inadequate anaesthesia may cause coughing or breath holding. Immediately deepen anaesthesia and manually ventilate the patient.

Sub-optimal head/ neck position: When inserting the LMA ProSeal™, LMA Unique™, LMA Classic™ and LMA Flexible™, keep the patient's head in the sniff position. When inserting the LMA Fastrach™ and LMA Supreme, keep the patient's head in the neutral position.

Incorrect mask deflation: Attempting to insert the LMA™ airway with the cuff partially inflated increases the chances of a down folded epiglottis.

Failure to press the LMA™ airway into the palatopharyngeal curve during insertion
Lack of water-soluble lubricant on the posterior surface of the LMA™ cuff
Using a mask that has surpassed its useful life of 40 insertions: The cuff and airway tubes of the reusable LMA™ devices are manufactured from silicone. With each use, the silicone degrades and loses flexibility. Prior to use, be sure to perform the manufacturer recommended Pre-Use Performance Tests.

Q?

What is the risk of aspiration with the LMA™ airway?

A.

The incidence of clinically detectable regurgitation with the LMA™ airway into the pharynx has been reported in various publications at approximately 0.1%. The incidence of aspiration with the LMA™ airway is low [~2:10,000] and is comparable to the incidence of aspiration associated with outpatient general anaesthesia with the face mask or endotracheal tube.
The following are practical guidelines to minimize risk of aspiration:
• Carefully select the patient and surgical procedure according to approved indications and contraindications
• Avoid inadequate anaesthesia upon insertion of the LMA™ airway and during surgery
• Avoid lubrication of anterior surface, excessive lubrication, or use of lidocaine gels containing non-aqueous solvents or silicones
• Ensure adequate neuromuscular reversal prior to termination of general anaesthesia
• Avoid gastric distention [minimize peak airway pressures, avoid inadequate paralysis and routinely place a gastric tube when anaesthetizing small infants].

Q?

How to select the correct size of LMA™ airway?

A.

Optimal use of the LMA™ airway depends, in part, on appropriate size selection. The patient selection information in the table below should be used only as an approximate guide. Clinical judgment based on many patient factors, including patient anatomy and physiology as well as weight, should be used in selecting an LMA™ airway size.

chart

In general, the size 4 LMA™ airway will be suitable for most adult female patients, and the size 5 LMA™ airway for adult males up to 100 kg. The new size 6 is intended for adult patients over 100 kg. The size 3 LMA™ airway should be considered as a paediatric size.

It is very important not to exceed the maximum cuff inflation amounts. If the maximum inflation volume of air is necessary to maintain a seal, the use of a larger size mask should be considered. Clinical studies have shown that a better seal is obtained using a larger size with less air. Using too small a mask and over-inflating the cuff will decrease cuff compliance, and may result in a poor fit within the pharyngeal space. Increased leak, gastric insufflations, and mal-positioning are more likely when the maximum cuff volume is exceeded, and may be associated with adverse events.

Consider changing to a larger size mask if leaks occur when the lungs are inflated to peak airway pressure < 20 cm H2O, but check first that this is not due to inadequate anaesthesia.
It is better to use a large size with small inflation volumes than a small size excessively inflated. Always have a larger and smaller size LMA™ airway immediately available.

Q?

Can the reusable LMA™ airways be cleaned and sterilized with alternate methods such as Steris®, Sterrad®, or pasteurization?

A.

The Laryngeal Mask Company Limited [LMC], manufacturer of the LMA™ airways, only recommends steam sterilization for their reusable products, at 134°C with a hold time of at least 10 minutes. The other methods listed above have not been validated by LMA.

Q?

Do any LMA™ devices contain latex?

A.

All LMA™ devices are latex-free. The LMA Classic™, LMA Flexible™, LMA Fastrach™ and the LMA ProSeal™ are made primarily of medical-grade silicone. LMA Unique™ and LMA Supreme™ are made primarily of medical-grade PVC.

Q?

How long LMA™ airway can be placed in a patient during the procedure and post procedure?

A.

LMA Classic™, LMA Flexible™, LMA Unique™ & LMA ProSeal™

The maximum duration for which an LMA™ airway can safely be used is not yet known; however, there is increasing evidence that the LMA™ airway may be safe for elective procedures in healthy patients lasting 4 to 8 hours in the hands of experienced users. If the LMA™ airway is used for prolonged periods, the respiratory function must be closely monitored, and a heat and moisture exchanger should be used. Also, intra cuff pressures should be checked periodically and maintained at 60 cm H2O. Nitrous oxide diffusion tends to cause a rise in intra cuff pressure in the LMA™ cuffs made of silicone. This may result in mal-position, postoperative sore throat, or other adverse events.

LMA Fastrach™

There are reports of pharyngeal edema and increased mucosal pressure attributed to the rigidity of the airway tube. Therefore, it is recommended the LMA Fastrach™ be removed once intubation has been accomplished. If the LMA Fastrach™ is left in place after intubation, the cuff should be partially deflated [to a pressure of 20-30 cm H2O].
The LMA Fastrach™ can be used as a stand-alone device for ventilation. There are no clinical data on how long the LMA Fastrach™ may be left in place, but there are anecdotal reports of leaving the LMA Fastrach™ in place for up to 4 hours without sequelae. If a clinical decision is made to leave the LMA Fastrach™ in place, the tube should be stabilized in the neutral position to prevent unnecessary movement.

Q?

LMA-EMERGENCY: What is the role of the LMA™ airway in the new American Heart Association [AHA] Guidelines?

A.

In adult Basic Life Support [BLS], the LMA™ airway is recommended as an alternative airway device to the bag-mask. The LMA™ airway may be considered a first choice resuscitation airway for BLS providers who are not trained in intubation.

In adult Advanced Cardiovascular Life Support [ACLS], the LMA™ airway is recommended as a Class II a device, defined as ‘Interventions are acceptable, safe, and useful-Considered within standard of care, reasonably prudent physicians can choose-Considered optional or alternative interventions by majority of experts’ The LMA™ airway is an airway adjunct and can be used if tracheal intubation is not possible.

In Paediatric Advanced Life Support [PALS], the LMA™ airway is classified as a Class Indeterminate device, defined as ‘Interventions can still be recommended for use, but reviewers must acknowledge that research quantity/ quality fall short of supporting a final class decision-Indeterminate is limited to promising interventions’. Therefore, the LMA™ airway may be utilized depending on the situation at the time of the arrest.

In Neonatal Resuscitation, the LMA™ airway is an alternative defined as ‘Cannot intubate-Cannot ventilate’ situation.

Q?

What are the medications approved for use with LMA MAD nasal- intra nasal drug delivery device?

A.

We provide a medication delivery system to the clinician to allow them to deliver intranasal medications that they feel are appropriate for the clinical situation.

We do not provide any medications.

We can provide information on many medications that have been studied and shown to be useful for intra-nasal medication delivery.

Q?

What is the LMA MAD Nasal™ dead space?

A.

The LMA MAD Nasal™ dead space [using a 3 ml syringe] is only 0.07 ml – round it up to 0.1 ml for clinical purposes and accuracy of dosing. For example, if the patient needs to receive total of 0.6 ml of medication with the LMA MAD Nasal™, the clinician needs to draw up 0.7 ml – 0.6 ml will go to the patient and 0.1 ml will remain inside the tip of the LMA MAD Nasal™ at the end of the procedure.

Q?

Is the LMA MAD Nasal™ one time use?

A.

LMA MAD Nasal™ is single patient use. It cannot be sterilized effectively. It may be reused only on the same patient for the same procedure.

Q?

How is the LMA MADgic™ used to accomplish fibre optic intubation?

A.

First spray the tongue, palate, uvula and posterior pharynx with local anaesthetic. After adequate time, insert an oral airway with the LMA MADgic™ bent to fit through the airway, or simply bend the device and advance it beyond the tongue base. Now atomize anaesthetic via the LMA MADgic™ onto the glottis and proximal trachea in 5-10 brief sprays [1 cc] as the patient takes deep inspirations – their cough will eventually diminish indicating adequate anaesthetic effect. Insert the FOB and, if desired, under direct visualization spray a jet of anaesthetic at the vocal chords and carina –confirming adequate anaesthesia. Proceed to intubation.

Q?

On what types of patients is the LMA MADgic™ typically used?

A.

The LMA MADgic™ can be used on both awake and fully induced patients. In the patient who is awake, careful application of topical anaesthetics results in complete anaesthesia of the airway, improving conditions for intubation. In the fully induced patient, the LMA MADgic™ rapidly applies topical anaesthetics to the glottic opening, larynx and trachea prior to intubation [or extubation], reducing sympathomimetic responses during these procedures. It can also be used at the end of a case to anaesthetize the glottic opening – reducing or eliminating cough during extubation.

Q?

What medications can be used with LMA MADgic™ device?

A.

The LMA MADgic™ allows the clinician to use whatever medications or mixture of medications he/ she wishes. It can be refilled and reused on the same patient.

Q?

If pre-packaged Lidocaine/ Lignocaine spray bottles are available for topical anaesthesia, why should LMA MADgic™ be used?

A.

Versatility: Clinician can choose medications, concentration and dose with the LMA MADgic™, not an option with a pre-packaged device.

Flexible stylette: The LMA MADgic™ stylette allows the clinician to shape the applicator to fit into the trachea, nose, down LMA™, etc.

Position independent: Pre-packaged bottles do not spray upside down, the LMA MADgic™ does.

Cost: Many consider the cost per case of these prefilled bottles to be less than the LMA MADgic™ if 100% of the drug in the bottle is used. However, these containers are often misplaced after only a few uses [or they expire] – wasting the drug and actually resulting in higher cost per patient.

Cross infection risk: The re-useable bottles are often not cleaned between cases – just replaced on the medication cart. Clinical investigations have noted patient secretions all over these devices.

Q?

How to clean a Tracheostomy tube?

A.

High-grade tracheostomy tubes and their accessories are supplied as ‘single-patient-use’ products and are therefore suitable for repeated use by the same patient. They can be cleaned and disinfected as necessary. Re-sterilization of these products is not permitted.
• Wash and disinfect your hands
• Remove the tracheostomy tube and its accessories and disassemble its individual parts
• Prepare the cleaning solution in the prescribed cleaning jar with the mesh basket
• Superficially pre-clean tracheostomy tube and its accessories under running water with a special cleaning brush. Use an angled brush for rigid tubes and straight brushes for flexible tubes.
• Soak the tracheostomy tube and its accessories in the prepared solution to dissolve incrustations and dried on secretions [mucous plugs]. Dwell time according to the manufacturer's instructions.
• Take the tracheostomy tube or their accessories out of the solution
• Clean the inner lumen using a cleaning brush of an appropriate size intended for this purpose and / or cleaning swabs. Avoid applying brushes to the area around the cuff, so as not to damage it, if present. Always insert brushes or the cleaning swabs from below.
• Then, rinse thoroughly with water to remove any residues of the solution that might adhere to the material.
• Carefully dry all parts. Store all parts that belong together in a clean, dry sealable container.
Never use household detergents, dental cleaning agents, alcoholic or lipid-containing solutions as they can damage the material. Their aggressive ingredients can destroy the tube or the cuff, leading to life-threatening injuries or health damage.

Q?

Why humidification process is needed?

A.

Humidification helps to keeps mucosa moist, as in normal breathing mechanism and mainly done by nose. It also helps keep the mucus thin, helps carina from drying out and prevents cracking of windpipe. Since the normal breathing procedure is compromised, it is advised to have an additional HME filter attached to outer end of tracheostomy tube to maintain moisture balance in entire mucosal layers from nose down to carina, by retaining part of the moisture and heat that is contained in the air exhaled through the HME and released back into the respiratory tract during inhalation.

Q?

What are the advantages of multiple fenestrations over single fenestration?

A.

The multiple fenestration design eliminates the risk of accidental puncture [inadvertent injury] of the posterior tracheal wall when introducing a suction catheter. Moreover, it is also associated with a lower risk of granulation tissue in-growth. A singly fenestrated tube [one-hole fenestration as opposed to multiple fenestrations] harbours the risk of damaging mucosa when it is introduced as well as the danger of puncture to the posterior tracheal wall when a suction catheter is inserted.

Q?

What is a fenestrated tracheostomy tubes and how fenestrations assist in speaking?

A.

Tubes suited for tracheostomized patients in whom vocal function of the larynx is preserved require fenestration, ideally a multiple fenestration, in the curve, where the expired air is channelled through the opening to the larynx that sets the vocal cords vibrating for phonation.
The expired air is only channelled through the larynx for voice production if,
• the previously mentioned fenestrations are present in the curve of the tube
• the lumen of the tracheostomy tube is closed with a finger, or if the positive pressure and mechanical suspension cause the speaking valve to close at every exhalation
• no auxiliary air escapes from around the tube

Q?

What is CUFFED TRACHEOSTOMY TUBE?

A.

Generally tracheostomy tubes are inserted below the vocal chords and have a bubble [also called a ‘cuff’] which fills with air that seals the airway. It also prevents liquid or particles from the mouth to pass down the trachea, thereby preventing infections. Cuffs are particularly necessary when a person has been unconscious, with a swallow deficit, altered mental status, or a compromised breathing status.

Q?

What are the complications associated with tracheostomy?

A.

The complications potentially occurring with tracheostomies can be classified as follows:

Early complications:

  • Bleeding
  • Tube mal-positioning
  • Tube obstruction caused by cuff herniation
  • The tube tip impinges on the carina or tracheal wall resulting in tube obstruction
    Pneumothorax
  • Delayed complications:

  • Blockage by secretions, either suddenly or gradually; rare when humidification and secretion suctioning are sufficient
  • Stomal infection
  • Necrosis by an overstretched trachea or overly inflated cuff
  • Mucosal ulcerations from asymmetrical cuff inflation, too strong cuff pressure or tube displacement.
  • Late complications:

  • Granuloma formation in the trachea can lead to respiratory difficulties after tracheostomy tube is removed
  • Persistent fistula in the region of the tracheostomy
  • Dilation of the trachea
  • Tracheal stenosis at the site of the tube cuff
  • Scar formation requiring surgical revision
  • Q?

    What is a ‘Tracheostomy tube’?

    A.

    A ‘tracheostomy tube’ is a breathing tube inserted into the trachea of the neck surgically. This tube acts as an artificial airway for mechanical ventilation, when normal breathing has been compromised due to various reasons like trauma or disease.