C Trach Instruction Manual Issue PAK2100003b

Instruction Manual English

Copyright © The Laryngeal Mask Company Limited, 2006 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means electrical, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher. LMA, LMA Classic, LMA CTrach, LMA Fastrach, LMA Flexible, LMA ProSeal, LMA Unique, The Laryngeal Mask Company Limited logo and its component parts are trademarks of The Laryngeal Mask Company Limited. The information given in this document is correct at the time of going to press. The manufacturer reserves the right to improve or modify the products without prior notification. Manufacturer’s Warranty: Please refer to the relevant manufacturer’s warranty provided in the LMA CTrach™ CD ROM. This warranty covers all defects and damage resulting from faulty materials or workmanship. This warranty is voided if damage is caused by improper use or treatment of the equipment, or an attempt to open the Viewer and the cradle case. Repair may only be carried out by The Laryngeal Mask Company Limited or any of its authorised service centres. The warranty covering the reliability and proper functioning of the equipment is voided if the user or any other unauthorised person tries to perform repairs. If the Viewer or charger exhibits any such defects or damage, a new unit will be supplied. If covered by the warranty, this will be done free of charge; otherwise the customer will be invoiced for the cost incurred. The Laryngeal Mask Company Limited will recover and properly dispose of old equipment. Caution: Specific product information applies in the USA. Contact LMA North America Inc. for details. www.LMANA.com

CONTENTS

1

DEVICE DESCRIPTION

1

10

REMOVING THE LMA CTrach™ AIRWAY PRIOR TO EXTUBATION 14

1.1 1.2 1.2.1 1.2.2

Introduction Description The LMA CTrach™ Airway The LMA CTrach™ Viewer

1 2 2 3

11

FAILURE TO INTUBATE

16

3

11.1 11.2 11.3

Downfolded epiglottis LMA CTrach™ too small or too large Other causes

16 17 17

2

INDICATIONS AND USAGE

3

CONTRAINDICATIONS

3

12

LMA CTrach™ VIEWER DESCRIPTION AND INSTRUCTIONS FOR USE

17

4

WARNINGS AND CAUTIONS

4

5

PRECAUTIONS

5

6

ADVERSE EFFECTS

5

7

PREPARATION FOR USE

6

7.1 7.2 7.3 7.4

Cleaning Sterilisation Performance tests Pre-insertion preparation

6 6 7 8

8

INSERTION

9

8.1

Selection of correct size of LMA CTrach™ Airway 9 Standard insertion of the LMA CTrach™ Airway 9

8.2

9

9.1 9.2

INTUBATION THROUGH THE LMA CTrach™ AIRWAY Introduction Passing the ETT through the LMA CTrach™ after identifying and aligning the glottic aperture with the centre of the Viewer display

12 12

13

12.1 Instructions for use 12.1.1 Viewer description 12.1.2 Operations 12.1.3 Preparation for use 12.1.4 Connection to LMA CTrach™ Airway 12.1.5 Device cleaning and disinfection 12.2 Troubleshooting 12.3 Battery indicator and charging 12.4 Storage and transport 12.5 Technical data 12.5.1 LMA CTrach™ Viewer specifications 12.5.2 Charger cradle specifications

18 18 18 18 19 20 20 20 21 21 21 21

13

FURTHER INFORMATION

21

14

LMA CTrach™ SPECIFICATIONS

21

15

APPENDIX

23

1

1

2

DEVICE DESCRIPTION

1.1 Introduction The LMA CTrach™ is a modified LMA Fastrach™, with an integrated fibreoptic system, which permits visualisation of the anatomical structures immediately in front of the aperture of the mask. Visualisation is achieved by connecting a detachable, portable colour display, the LMA CTrach™ Viewer, to the LMA CTrach™ Airway after insertion. When in position, the Viewer is just above the patient’s chin, so that it is directly in line with the actual anatomy being displayed. Thus, the LMA CTrach™ is designed to allow users to observe that the glottic aperture is aligned with the mask aperture prior to passing an endotracheal tube (ETT). As with a conventional laryngoscope, actual passage of the tube through the vocal cords can also be observed. However, unlike the view obtained using a laryngoscope, the LMA CTrach™ Viewer provides a view from the under side of the ETT. Like its predecessor, the LMA Fastrach™, the LMA CTrach™ Airway also shares the unique feature that it can be used as an airway device in its own right, enabling ventilatory control and patient oxygenation to be continuous up to the moment of intubation, thereby lessening the likelihood of desaturation. It also permits single-handed insertion from any user position without moving the head and neck from a neutral position, and can also be placed without inserting fingers in the patient's mouth. The detachable, light-weight, portable, LMA CTrach™ Viewer is powered by a rechargeable battery. The Viewer slots into place in front of the connector on the LMA CTrach™ Airway by means of a magnetic latch connector. When positioned, the Viewer is located immediately overlying the larynx. This makes the LMA CTrach™ an intuitive system to use, because the larynx is seen on the display in the same position as the actual anatomy. Thus, while manipulating either the endotracheal tube or the device itself, the user’s arm-brain co-ordination is preserved.

The LMA CTrach™ can be used in the same situations as the LMA Fastrach™ - to avoid desaturation during intubation - anticipated or unexpected difficult intubation for anatomical reasons - difficult intubation due to the need for manual in-line neck traction - difficult facemask ventilation, due to the need for manual inline neck traction or for anatomical reasons - difficult extubation - emergency situations where there is restricted access to the patient or when personnel with intubation skills are not available, or where there is suspected cervical spine injury - To minimise physiological disturbance1,2 Because the LMA CTrach™ can be used either as an airway device in its own right, or simultaneously as an intubating tool, ventilatory control is continuous. It will continue to aid oxygenation of the patient while intubation equipment is being prepared and up to the moment of passing the ETT. Like intubation with the LMA Fastrach™, correct insertion of the LMA CTrach™ does not require or cause significant movement of the head and neck. 1 Baskett PJF, Parr MJA, Nolan JP. The Intubating Laryngeal Mask. Result of a multicentre trial with experience of 500 cases. (Anaesthesia 1998; 53: 1174-1179) 2 Choyce A, Avidan MS, Harvey A, et al. The cardiovascular response to insertion of the intubating laryngeal mask airway. (Anaesthesia 2002; 57 (4): 330-333)

LMA CTrach™ Viewer

Anatomically curved airway tube

Handle Fibreoptic channels run along the airway tube

Epiglottic elevating bar

Cuff LMA CTrach™ Airway

Inflation indicator balloon

Inflation line

Valve

Figure 1: Features of the LMA CTrach™ system.

1.2 Description The LMA CTrach™ is a 2 component system comprising the LMA CTrach™ Airway and LMA CTrach™ Viewer 1.2.1 The LMA CTrach™ Airway The LMA CTrach™ Airway is latex-free and incorporates the following features (See Figure 1): - A rigid, anatomically-curved airway tube terminating in a standard 15mm connector. The tube is wide enough to accept a cuffed, 8mm endotracheal tube (ETT) and short enough to ensure passage of the ETT cuff beyond the vocal cords. The dorsal surface of the LMA CTrach™ Airway tube is calibrated at approximately 1cm intervals. The calibrations act as a guide for an airway manoeuvre described in section 11.1 of this instruction manual. In addition, it is fitted with a rigid handle, permitting one-

handed insertion, removal and adjustment of the device in relation to the larynx, as well as serving to steady the device whilst inserting an ETT through it or passing a tube behind it into the oesophagus. - Two built-in fibreoptic channels are positioned on either side of the lateral borders of the curved airway tube, protected within reinforced sheaths. The 2 fibreoptic bundles comprise the light guide, to illuminate the anatomy, and a 10,000 pixel image guide to transfer the image of the larynx to the Viewer. The 2 fibreoptic bundles converge and emerge to terminate at a fixed angle of 30˚ with respect to the plane of the mask at the distal end of the Airway tube, under the epiglottic elevating bar, to optimise light projection into the larynx. This angle ensures that when the mask is correctly placed, the fibreoptic view is directed approximately towards the

3

centre of the laryngeal inlet unless the larynx itself is displaced or distorted by local pathology. When the larynx is distorted or displaced, the user may need to manipulate the handle of the device to locate the glottic aperture. Caution: the built-in fibreoptics are fully autoclavable and should not be removed from the device at any time.

Note: The device measures more than 25mm in transverse diameter at its widest point. - An Epiglottic Elevating Bar (EEB) in the mask aperture. The distal end of the EEB is not fixed to the mask floor, allowing it to elevate the epiglottis when an ETT is passed through the aperture. The EEB has been modified with an aperture or viewing window to enable the user to view the anatomy in front of the bar and thus verify correct device position and make any necessary changes to position prior to passing the ETT. - A magnetic latch connector is located at the top of the LMA CTrach™ Airway tube for securely attaching the detachable LMA CTrach™ Viewer onto the Airway. The dual fibreoptic channels come together in this proprietary connector. Exact fibreoptic alignment of the Viewer with the Airway is ensured, to produce an image of the larynx. - Prior to using the LMA CTrach™ System, fibreoptic alignment of the Viewer with the Airway is confirmed by moving the focus wheel until a clear, sharp colour image is displayed on the Viewer. The LMA CTrach™ Airway is a reusable device. Before each use it must be cleaned and sterilised in accordance with the procedures set out in section 7 of this manual. The manufacturer, The Laryngeal Mask Company, recommends that the device be used as an airway management device for maximum of 20 times before being discarded. A record card is provided for tracking usage of the device. The Viewer is intended for multiple uses if properly maintained in accordance to the recommendations stated in this manual.

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1.2.2 The LMA CTrach™ Viewer The LMA CTrach™ Viewer provides the light source, image treatment and user interface. The image of the larynx is displayed on the high resolution 86mm LCD colour display. The Viewer comprises a high efficiency LED, proprietary optical system and the latest technology CCD (charged couple device) sensor to convert the image into the digital image displayed on the Viewer. It is light-weight (~200g), portable and wireless. The Viewer is powered by a rechargeable battery, which when fully charged provides up to 30 minutes continuous use. There is a self standing or wall mountable charger cradle for recharging the Viewer when it is not in use. The Viewer is attached to the LMA CTrach™ Airway by slotting it onto the magnetic latch connector. Once the Viewer is in place and the power is on, function keys enable adjustment of light, brightness, image gain, colour and image position (see Section 12.1.2). To facilitate teaching, a USB 2.0 port enables the user to record and download images onto a computer.

2

INDICATIONS AND USAGE

The LMA CTrach™ Airway is indicated as an alternative for the facemask for achieving and maintaining control of the airway in routine and emergency situations, including anticipated or unexpected difficult intubation situations. The LMA CTrach™ is indicated for use as a guide for intubation of the trachea. It is not indicated for use as a replacement for the endotracheal tube. Additionally, the LMA CTrach™ Airway is indicated as a method of establishing a clear airway in the profoundly unconscious patient who presents with absent glossopharyngeal and laryngeal reflexes.

protection. The LMA CTrach™ is therefore contraindicated for routine use in the following patients: - Non-fasted patients, including patients whose fasting cannot be confirmed, and in other situations where there may be retained gastric contents. - Patients who are grossly or morbidly obese, more than 14 weeks pregnant, or those with multiple or massive injury, acute abdominal or thoracic injury, any condition associated with delayed gastric emptying, or using opiate medication prior to fasting. - Patients with fixed decreased pulmonary compliance, such as patients with pulmonary fibrosis, because the LMA CTrach™ forms a low pressure seal around the larynx. - Adult patients who are unable to understand instructions or cannot adequately answer questions regarding their medical history, since such patients may be contraindicated for LMA CTrach™ use. - Patients whose head needs to be turned to the side during surgery. - Patients in the prone position. When used in the profoundly unresponsive patient in need of resuscitation, or in a difficult airway patient in an emergency situation (ie “cannot intubate, cannot ventilate”), the risk of regurgitation and aspiration must be weighed against the benefit of establishing an airway. The LMA CTrach™ should not be used in the emergency situation in patients who are not profoundly unconscious and who may resist LMA CTrach™ insertion. The metal tube and handle of the LMA CTrach™ make it unsuitable as an airway during magnetic resonance imaging. (b) When used as a guide for intubation of the trachea: Intubation through the LMA CTrach™ is contraindicated in the presence of oesophageal or pharyngeal pathology.

3

CONTRAINDICATIONS

a) When used alone:

4

WARNINGS AND CAUTIONS

Since the LMA Fastrach™ does not protect against regurgitation, the LMA CTrach™ is also unlikely to offer

- In order to use the LMA CTrach™ safely and effectively, the user must be familiar with the information in this manual

and use it accordingly. It is recommended that initial experience be gained in elective, non-difficult airway patients. Practice in intubation training manikins is also recommended. - For successful insertion and use of the device, reflexes must be obtunded. A patient may otherwise cough or develop laryngeal spasm during attempted insertion of the device or intubation through it. - For detailed instructions on the use of an ETT, please refer to the relevant manufacturer’s instructions for use. Do not attempt to use an ETT in an inappropriate or contraindicated manner. - The use of a standard, curved, plastic ETT is not recommended as it may be associated with increased likelihood of laryngeal trauma. The Laryngeal Mask Company recommends using the LMA Fastrach™ ETT. It is recommended that the LMA CTrach™ Airway be removed once intubation has been accomplished. If, however, a clinical decision is made to leave the LMA CTrach™ in place after intubation, the LMA CTrach™ Airway cuff should be deflated to 20~30 cm H2O pressure and care taken to avoid unnecessary movement of the head and neck from the neutral position. If the LMA CTrach™ is the sole airway, it is very important that cuff pressure is monitored and the tube is stabilised in the neutral position to prevent unnecessary movement. There are currently no clinical data on how long the LMA CTrach™ may be left in place. - There are data based on cadaveric and patient studies suggesting that the LMA Fastrach™ may exert pressure on the unstable cervical spine. The clinical significance of this pressure is unknown. The LMA Fastrach™ has been used successfully in cases involving patients with cervical spine disorders. Clinicians must weigh the theoretical risk against the benefits of establishing an airway with the LMA CTrach™ in patients with suspected cervical spine pathology. - As with all reusable devices, the components of the LMA CTrach™ will degrade over time and therefore the number of uses must be limited. With proper cleaning, sterilisation and handling, the LMA CTrach™ Airway is warranted for a maximum of 20 uses. Continued use beyond this number is not recommended as degradation of the components may occur, resulting in impaired performance or abrupt failure.

5

6

- The device is delivered non-sterile and must be cleaned and sterilised before initial use and before each subsequent use. - Failure of any one performance test described in section 7 indicates that the device has passed its useful life and should not be used. - Lubricate only the posterior surface of the LMA CTrach™ mask tip during insertion to avoid blockage of the aperture or aspiration of the lubricant. - Never use the handle as a lever during insertion as this will cause the mask to press into the tongue, making insertion more difficult (see section 8 for insertion instructions). - Do not exceed the maximum recommended inflation volumes during use. Normally about half the maximum recommended volume is appropriate. - Do not attempt to insert the LMA CTrach™ Airway with LMA CTrach™ Viewer attached. - Always remove the LMA CTrach™ Viewer before attempting to remove the LMA CTrach™ Airway from the patient. - To avoid damage to the eyes, do not look directly at the LMA CTrach™ Viewer light source.

5

PRECAUTIONS

a) Device preparation - Careful handling is essential. Some components of the LMA CTrach™ Airway are made of medical grade silicone which can be torn or perforated. Avoid contact with sharp or pointed objects at all times. - Do not expose the valve (the white plastic piece protruding from the blue pilot balloon) to any cleaning solution as it may cause premature valve failure. - Any air or moisture left in the cuff will expand in the high temperature and low pressure environment of the autoclave, causing irreparable damage to the cuff and/or blue pilot balloon. - The integrity of the LMA CTrach™ materials may be adversely affected by autoclave temperatures exceeding 275°F or 135°C. - Gloves should be worn during the preparation and insertion of the LMA CTrach™ to minimise contamination. b) During use - Failure to remove the stabiliser rod prior to unthreading the LMA CTrach™ over the ETT may result in damage to the pilot balloon or inflation line of the ETT.

Caution: Ensure the anaesthesia circuit connector does not interfere with the connection between the Airway and Viewer. Interference can result in an unclear image that can not be corrected with the focus wheel. Caution: The image displayed on the Viewer can become obscured if lubricant comes in contact with the fibreoptics. Do not pass the lubricated ETT beyond the EEB (or transverse marker line on the LMA Fastrach™ ETT) whilst pre-lubricating the LMA CTrach™ Airway. Caution: Ensure the Viewer has sufficient battery charge before use. Caution: Always pre-focus the LMA CTrach™ Viewer prior to use.

6

ADVERSE EFFECTS

- Both minor adverse effects (e.g. sore throats) and major adverse effects (e.g. aspiration) following standard LMA™ (LMA Classic™) use have been reported in literature. - There is one report of oesophageal perforation following intubation attempts through the LMA Fastrach™. The patient was subsequently found to have radiological evidence of preexisting oesophageal pathology. In addition to minor sore throat and hoarseness, there have been isolated reports of vallecular bleeding, pharyngeal oedema, and epiglottic oedema with LMA Fastrach™ use. - Review of published literature shows the incidence of aspiration with the LMA™ airway is low (0.012%), with the main causes being inappropriate patient selection and inadequate depth of anaesthesia.3 - The incidence of sore throat following LMA™ Airway use is approximately 13%, and is usually mild and shortlived3; however, severe or prolonged sore throat, sometimes accompanied by dysphagia and tissue burns, has been reported in patients in whom an improperly cleaned or sterilised reusable mask has been used. Information regarding warnings and preparation for use is provided in Section 4 and 7 of this manual. - Infrequent neurovascular events reported with LMA™ airway use include cases of hypoglossal nerve injury, tongue numbness secondary to lingual nerve injury, tongue cyanosis, tongue macroglossia, recurrent laryngeal nerve injury and vocal cord paralysis. These complications are most likely the result of malposition or excessive intracuff pressure, causing

compression of nerves and/or blood vessels. Cuff malposition or excessive cuff pressure can be exacerbated by incorrect mask size, prolonged surgery and use of nitrous oxide. 3 Brimacombe JR, Laryngeal Mask Anesthesia. Principles and Practice, Saunders 2004.

7

PREPARATION FOR USE

Warning: The LMA CTrach™ is delivered non-sterile and must be cleaned and sterilised before initial use and before each subsequent use. The packaging cannot withstand the high temperatures of autoclaving and should be discarded before sterilisation. The LMA CTrach™ Viewer cannot withstand autoclaving and must be disinfected between each patient use following the separate instructions supplied in Section 12. Warning: Careful handling is essential as some components are made of medical grade silicone which might be torn or perforated. Avoid contact with sharp or pointed objects at all times. After use, handle the device in a manner that will minimise the risk of healthcare personnel exposure to biohazardous material. 7.1 Cleaning – instructions for airway device only – (See separate instructions in Section 12 for LMA CTrachTM Viewer) - Thoroughly wash the cuff and airway tube in warm water, with a dilute (8-10%) sodium bicarbonate solution, until all visible foreign matter is removed. Mild detergents are also acceptable for cleaning the Airway when used per the manufacturer’s instructions at the proper dilutions. The detergent must not contain skin or mucous membrane irritants. A specific cleaner found to be compatible with LMA™ airway use is Endozime® (Ruhof, Valley Stream, NY). - Warning: Do not use germicides, disinfectants, or chemical agents such as glutaraldehyde (Cidex®), or ethylene oxide, phenol-based cleaners, iodine-containing cleaners, or quarternary ammonium compounds to clean or sterilise the LMA CTrach™. Such substances are absorbed by the LMA CTrach™ materials resulting in exposure of the patient to unnecessary risk and possible deterioration of the

LMA CTrach™. Do not use an LMA CTrach™ that has been exposed to any of these substances. - Caution: Do not expose the LMA CTrach™ valve (the white plastic piece protruding from the blue pilot balloon) to any cleaning solution as it may cause premature valve failure. If the inner valve is exposed to a cleaning solution, rinse thoroughly under warm flowing tap water, remove excess moisture, and allow to dry. - Clean the interior of the airway tube using a small soft bristle brush (approximately 17mm in diameter). Ensure the whole interior of the metal tube is cleaned. Gently insert the brush into the airway tube from the mask end, taking care not to damage the EEB, which should be lifted carefully out of the way before inserting the brush. Caution: Never insert the brush into the viewing aperture of the EEB in order to gain access to the airway tube, as this may cause damage to the fibreoptic lens which lies immediately behind the aperture. To clean secretions from the aperture in the EEB, lift the EEB carefully away from the fibreoptic lens area before gently cleaning with a soft brush. - Thoroughly rinse in warm, flowing tap water to remove cleaning residues. Carefully inspect surfaces to ensure that all visible foreign matter has been removed. - The fibreoptic lenses of the LMA CTrach™ Airway and Viewer should be cleaned using an alcohol soaked wipe and blown dry. When dust particles or black speckling is seen on the Viewer image, remove the Viewer and wipe the top of the magnetic latch connector with an alcoholic wipe. Replace the Viewer to confirm the particles have been removed. Repeat if necessary. Caution: The image displayed on the Viewer can become obscured if lubricant comes into contact with the fibreoptics. Do not pass the lubricated ETT beyond the EEB (or the transverse marker line on the LMA Fastrach™ ETT) either whilst pre-lubricating the LMA CTrach™ Airway tube or prior to visualisation of the vocal cords. - Repeat the above steps as necessary. - Warning: Failure to properly clean, rinse, and dry a device may result in retention of potentially hazardous residues or in inadequate sterilisation.

7

7.2 Sterilisation (See separate instructions in Section 12 for LMA CTrach™ Viewer) Warning: Steam autoclaving is the only recommended method for sterilisation of the LMA CTrach™ Airway. Do not use ethylene oxide gas sterilisation. Adherence to the following procedures is essential to ensure sterilisation without damage to the device: - Immediately prior to steam autoclaving, remove all air from the cuff. Carefully insert a syringe into the valve port and fully deflate the cuff to a high vacuum. Ensure that the valve and the syringe are dry. Caution: Any air or moisture remaining in the cuff will expand in the high temperature and low pressure of the autoclave, causing irreparable damage to the cuff and pilot balloon. Do not use excessive force when inserting the syringe into the valve port. Remove the syringe from the valve port before autoclaving to avoid damage to the valve. - If a deflated mask immediately and spontaneously reinflates, even slightly, do not autoclave or reuse this device. This may indicate a leak in the cuff or a malfunctioning valve. It is normal, however, for the cuff to reinflate slowly over a period of several hours as the silicone material is slightly gas-permeable. - Autoclave following the autoclave manufacturer’s recommendations and applicable institution and industry guidelines for temperature and time. All autoclave cycles typically used for porous items are acceptable, provided the maximum temperature does not significantly exceed 135°C (275°F). Caution: The integrity of the materials may be adversely affected by autoclave temperatures significantly exceeding 275˚F or 135˚C. As autoclaves vary in design and performance characteristics, cycle parameters should always be verified against the autoclave manufacturer’s written instructions for the specific autoclave, the load configuration being used and applicable to national guidelines. Healthcare facility personnel are responsible for adhering to the process specified and validated in their facility and for maintaining process control. Failure to do so may invalidate the healthcare facility’s sterilisation process. - After autoclaving, allow to cool to room temperature before use.

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7.3 Performance tests The non-clinical tests described must be conducted before each use of the device. The performance tests should be conducted in an area and in a manner consistent with accepted medical practice that minimises contamination before insertion. Caution: Gloves should be worn at all times during testing, preparation and insertion. Performance test 1: Visual inspection LMA CTrach™ Airway: Examine the surface of the device for damage, including cuts, tears, or scratches. If damage is present on any surface of the device it must not be used. Particulate contamination: Examine to ensure that the device is free from blockage or loose particles. Any particles present in the tube, or on the exterior of the mask should be removed as they may be inhaled by the patient after insertion. Where available, a fibrescope may be used to examine the interior of the tube. Examine the viewing aperture in the EEB to ensure it is not blocked with secretions or has visible particulate matter adhering to it. Also carefully inspect the connector and viewing ends of the fibreoptic cables to ensure they are not contaminated with particulate matter or secretions. Warning: Do not use the LMA CTrach™ Airway when visible particles cannot be removed from inside the airway. Examine the angle between the straight part of the metal tube and the anterior plane of the inflated cuff. To provide the optimal intubation path with the head and neck in the neutral position, the angle should be just less than 90˚ and it should never exceed 90˚. Epiglottic Elevating Bar (EEB) damage: Examine the aperture in the mask. Gently probe the EEB to ensure it is not damaged. The free end of the bar should lie in contact with the floor of the mask. If it does not, it may fail to engage correctly with the epiglottis and the device should not be used. Do not attempt to repair a broken or otherwise damaged bar. Do not remove the bar. Warning: Do not use the LMA CTrach™ Airway if the EEB is broken or otherwise damaged or if the free end does not lie in contact with the floor of the mask.

Performance test 2: Deflation and inflation

7.4 Pre-insertion preparation

Cuff deflation: Carefully insert a syringe into the valve port and fully deflate the cuff so that the cuff walls are tightly flattened against each other. Remove the syringe from the valve port. Examine the cuff walls to determine whether they remain tightly flattened against each other. Warning: Do not use if the cuff reinflates immediately and spontaneously, even if only slightly.

Prior to using the LMA CTrach™ system, ensure the LMA CTrach™ Viewer is focused, using the method described to confirm fibreoptic pathway integrity, under section 7.3. Caution: Once pre-focusing of the LMA CTrach™ Airway and Viewer has been performed, the focus wheel should not be readjusted once the device is being used in a patient.

Cuff Leakage and Symmetry: Stress-test the cuff by overinflation from complete vacuum, as follows: size 3 with 30ml, size 4 with 45ml and size 5 with 60ml. Any tendency of the cuff to deflate indicates a leak and should be evident after two minutes. Examine the symmetry of the inflated cuff. There should not be uneven bulging at either end or on the sides. Warning: Do not use the LMA CTrach™ Airway if cuff leakage is present or if there is uneven bulging of the cuff when it is overinflated.

Caution: Always pre-focus before using the LMA CTrach™ system.

Inflation Indicator Balloon diameter: While the device remains overinflated, examine the blue inflation indicator balloon situated beneath the syringe port and valve. The balloon shape should be elliptical and not spherical, with no bulges. Warning: Do not use the LMA CTrachTM Airway if the inflation indicator balloon is spherical or irregular shaped. Performance test 3: Fibreoptic pathway integrity Connect the LMA CTrach™ Viewer after ensuring its battery is fully charged. The optical system is designed to focus from 7-8 mm from the end of the image fibre to infinity. Switch on the power to the display and place a sterile object (or the fibreoptic Visual Test Card) 1-2 cm away from the viewing window in the EEB. Turn the focus wheel, until the object comes into focus.

Figure 2: The LMA™ Cuff-Deflator may be used with the LMA CTrach™.

Check that the object is clearly visible and can be brought into focus after suitable focal adjustment. Loss of any part of the image indicates damage to the fibreoptic image path. Poor light transmission may indicate breakage of light-carrying fibres. Warning: Failure of any one test indicates that the device is damaged or has passed its useful life and should be discarded.

Figure 3: Place a bolus of lubricating gel on the posterior surface of the deflated mask tip; do not lubricate the anterior surface.

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Prior to insertion, the cuff should be tightly deflated with its edges angled away from the aperture side of the mask so that it forms a smooth "spoon shape" without any wrinkles. The LMA™ Cuff-Deflator (available from the distributor) is recommended to deflate the cuff (see Figure 2). Alternatively, deflation can be accomplished by pressing the mask, with its aperture side down, on a flat sterile surface, or the palm of the gloved hand. The fingers may be used to guide the cuff into the desired shape during deflation. Attempt to eliminate any wrinkles especially on the distal edge of the cuff. It is essential not only to remove all air from the cuff but to create a vacuum inside it. This is facilitated by gently pulling the air inflation line straight while withdrawing all remaining air with a large syringe. Although it is necessary to pull hard on the syringe piston to create the necessary vacuum, do not pull too hard on the inflation line, as this causes the syringe to disconnect from the valve port. A completely flat and smooth leading edge facilitates insertion, avoids contact with the epiglottis, and is important to ensure success when positioning the device. Apply a bolus of lubricant to the posterior mask tip just before insertion to prevent drying of the lubricant. Warning: Lubricate only the posterior surface of the mask to avoid blockage of the aperture or the viewing lens or aspiration of the lubricant (Figure 3). A water-soluble lubricant, such as K-Y Jelly®, may be used. Do not use silicone-based lubricants as they degrade the components. Use of lubricants containing lignocaine [USA: Lidocaine] is not recommended as they can delay the return of the patient's protective reflexes, may provoke an allergic reaction, or may affect the surrounding structures, including the vocal cords. The manufacturer recommends the use of anti-fogging solution on the fibreoptic lenses.

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INSERTION

Before using, the user should be familiar with the information in this manual. Warning: It is strongly recommended that initial experience be gained in elective, non-difficult airway patients. Practice in intubation training manikins is also recommended.

It is possible to obtain an unreliable or obstructed airway if the device is inserted incorrectly. Important points to note are assurance of an adequate depth of anaesthesia or unconsciousness, correct approach to the mouth, and the avoidance of the use of force. 8.1 Selection of correct size of LMA CTrach™ Airway Check that the size of the LMA CTrach™ Airway is correct for the patient. Clinical judgement must be used in selecting an appropriate size. Laryngeal position is not related to patient size or weight in a linear fashion. The table below is therefore an approximate guide only. LMA CTrach™ Airway Size 3 4 5

Patient Size Children 30-50kg Adult 50-70kg Adult 70-100kg

Check for correct deflation and lubrication, as described previously. Ensure a spare LMA CTrach™ Airway is available and prepared for immediate use. Pre-oxygenate and follow standard monitoring procedures. Ensure an adequate depth of anaesthesia or unconsciousness before inserting the Airway. The Airway may also be inserted with the patient awake after adequate pharyngeal topicalisation. 8.2 Standard insertion of the LMA CTrach™ Airway Position of user in relation to patient: Insertion may be achieved from any position relative to the patient’s head. Position of head: When possible, a pillow should be placed under the head to achieve a neutral position. Provided the head and neck are in the neutral position, no head or neck manipulation is required. Do not extend the head. Always insert the device before attaching the LMA CTrach™ Viewer. Inserting the LMA CTrachTM Airway: Hold the Airway by its handle between the thumb and fingers, as shown in Figure 4. Carefully position the mask tip so it is flat against the hard palate just inside the mouth, immediately posterior to the upper incisor teeth. Slide the mask tip back and forth on the palate briefly to distribute lubricant over the palate.

Slide the mask backwards following the curve of the rigid tube. Do not commence rotation as shown in Figure 5 until the straight part of the metal tube is in contact with the patient’s chin (see Figure 4a). Whilst rotating, maintain contact of the curved metal tube against the chin. It may be necessary to draw the mouth open momentarily to permit the widest part of the mask to enter the oral cavity. Do not use the handle as a lever to force the mouth open. If the patient’s anatomy makes it difficult to press the mask up against the hard palate, for example in extreme obesity combined with a short neck, insert initially with the handle angled to one or other side of the mid-line. Once the tip of the mask has started to slide down the posterior pharyngeal wall, it will be possible to return the handle position to the mid-line to complete the insertion. The elastic nature of the mask will permit it to lie flat against the palate even though the metal tube is somewhat rotated to one or other side during the first part of insertion. The tube curvature closely follows the anatomical curve of the palate and posterior pharyngeal wall with the head and neck in neutral position. Keep the mask firmly applied to the soft palate and posterior pharyngeal wall as it is swung down into place, to avoid accidental folding of the mask tip (Figure 5). Warning - never use the handle as a lever during insertion as this will cause the mask to press into the tongue, making insertion more difficult.

Note: about one half of the maximum inflation volume is usually appropriate. Warning: Do not exceed the maximum cuff inflation volumes. If leaks occur at 60cm H2O cuff pressure, either too large a tidal volume or flow rate is being used, the device is too small, is not fully inserted, or the patient is not fully anaesthetised.

Figure 4: Slide the distal end of the mask briefly up and down while pressing it against the hard palate as shown. This helps distribute the lubricant. Ensure the mask tip is not folded over at this time.

N.B. Maintain neutral position for the head and neck

Note: After insertion, the tube should emerge from the mouth directed somewhat caudally so that it is lying approximately parallel to the plane of the inner surface of the upper incisors. Inflate the cuff with just enough air to obtain a seal, corresponding to a pressure of approximately 60cm H2O (Figure 6) or to a volume sufficient to permit gentle positive pressure ventilation by hand at a tidal volume not exceeding 8ml/kg. Frequently, only half of the maximum volumes recommended in the manual are sufficient to obtain seal. LMA CTrach™ Airway Size 3 4 5

Suggested Cuff Inflation Volume 10ml 15ml 20ml

Maximum Cuff Inflation Volume 20ml 30ml 40ml

Figure 4a: The straight part of the metal tube should be in contact with the patient's chin prior to commencing the final rotational part of the insertion manoeuvre.

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Connecting to the anaesthesia system: Connect the device to standard anaesthesia connectors or inflation bellows for ventilation, taking care to avoid dislodgement. The LMA CTrach™ system is designed for use with standard 15 mm connectors.

9 INTUBATION THROUGH THE LMA CTrach™ AIRWAY

Note: Connectors that have external flanges, filter housing or external diameters beyond 23 mm can interfere with the Viewer.

In order to achieve optimal intubation, it is recommended that the following type of ETT be used with the LMA CTrach™: it should be straight, wirereinforced, cuffed, between 6-8mm internal diameter and capable of being passed entirely through the Airway, including the pilot balloon and valve. The LMA Fastrach™ ETT range has been developed by the manufacturer in collaboration with the inventor specifically for use with these devices.

9.1 Introduction

Figure 8: Hold the LMA CTrach™ Airway handle firmly while attaching the viewer and throughout the intubation procedure.

Figure 5: Swing the mask into place in a circular movement, ensuring pressure is maintained against the palate and posterior pharynx. Never use the handle as a lever. Do not press the handle inwards beyond the point at which the device fits most easily into place.

Figure 7: The LMA CTrach™ can be used on its own to ventilate the patient.

Before any further steps are taken, oxygenate the patient using gentle positive pressure ventilation to airway pressures of less than 20cm H2O and a tidal volume not exceeding 8ml/kg (Figure 7). Capnography should be used to confirm adequate gas exchange.

Figure 6: Inflate the mask, without holding the tube or handle, to a pressure of approximately 60cm H2O.

Connecting the LMA CTrach™ Viewer: Warning: Ensure the anaesthesia circuit does not interfere with the connection between the Airway and the Viewer. Only at this point should the LMA CTrach™ Viewer be attached onto the connector. Hold the Airway handle firmly while attaching the Viewer (see Figure 8). Warning: To avoid the theoretical risk of pressure trauma to the posterior pharyngeal wall, the Viewer should not be left attached to the device for prolonged periods without supporting the combined weight of the assembly using the handle.

Take care not to allow the Airway to become displaced by the weight of the Viewer. Switch on the Viewer and obtain an optimised image of the glottis. Full instructions for adjusting the Viewer image parameters are provided in section 12.1.2 of this manual. Caution: If an image of the glottis can not be seen on the Viewer, firstly ensure the Viewer is correctly attached onto the magnetic latch connector. Upon verification of correct Viewer positioning, follow the clinical troubleshooting steps described in section 11 of this instruction manual. Stabilising the LMA CTrach™ Airway: Should the Airway be left in place (either as the sole airway or after intubation has been accomplished), care should be taken to ensure its stabilisation in the neutral position, e.g. with bilateral bite blocks, as movement of the head or neck could result in less than ideal positioning. The bite blocks should be removed prior to intubation to permit adjustment of the Airway position. Warning: if the LMA CTrach™ is the sole airway, it is very important that cuff pressures are monitored and the tube stabilised in the neutral position to prevent unnecessary movement. DO NOT LEAVE THE VIEWER ATTACHED TO THE AIRWAY DEVICE FOR PROLONGED PERIODS WITHOUT MANUALLY SUPPORTING THE DEVICE HANDLE.

Warning: The use of a standard curved plastic ETT is not recommended for intubation through the LMA CTrach™ Airway as this may be associated with a higher likelihood of laryngeal trauma. For detailed instructions on the use of an ETT, please refer to the relevant manufacturer’s instructions for use. The user should be familiar with complete ETT instructions issued by the relevant manufacturer prior to use. The ETT must not be used in an inappropriate or contraindicated manner. It should be noted that the LMA CTrach™ Airway cannot be removed after intubation unless the connector can be removed from the chosen ETT. The following instructions assume that the straight, cuffed, wire-reinforced LMA Fastrach™ ETT is being used. Where intubation is to be performed immediately after insertion of the device, it is recommended that the ETT is lubricated and passed several times through the Airway tube before insertion of the Airway to distribute lubricant and ensure smooth passage of the ETT. Caution: The image displayed on the Viewer can become obscured if lubricant comes into contact with the fibreoptics. Do not pass the lubricated ETT beyond the EEB (or the transverse marker line on the LMA Fastrach™ ETT) either whilst pre-lubricating the LMA CTrach™ Airway tube or prior to visualisation of the vocal cords.

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If it is decided not to attempt intubation immediately, secure the device in the same fashion as the LMA Classic™. Stabilise the LMA CTrach™ in position, preferably with bilateral biteblocks at least 3cm thick and tape in position. DO NOT LEAVE THE VIEWER ATTACHED TO THE AIRWAY DEVICE FOR PROLONGED PERIODS WITHOUT MANUALLY SUPPORTING THE DEVICE HANDLE. 9.2 Passing the ETT through the LMA CTrach™ Airway after identifying and aligning the glottic aperture with the centre of the Viewer display

When using the LMA Fastrach™ ETT, the longitudinal line on the tube should face the handle of the device. Now, very gently pass the tube about 1.5cm past the 15cm line (or the transverse marker line on the LMA Fastrach™ ETT). Use of the Chandy manoeuvre is recommended while attempting to pass the tube. The Chandy manoeuvre involves gripping the handle firmly, using it to draw the larynx forwards a few millimeters. This is a lifting action and is not to be confused with a levering action (see Figure 10). The manoeuvre increases seal pressure and ensures optical alignment of the axes of the trachea and the ETT.

The EEB will be seen to rise as the tip of the ETT emerges from underneath it. Gently proceed to push the tube through the vocal cords (Figure 11). Once correctly placed, the Viewer should be detached and then the ETT should be inflated in accordance with standard procedures (See Figure 12). Confirm intubation by conventional means, e.g. end tidal CO2.

The steps to be followed are illustrated in Figures 9, 10, 11, 12, and 13 using the LMA CTrach™ as a sole airway device. It is assumed the glottis has been identified on the Viewer display, the patient is anaesthetised and paralysed and has been pre-oxygenated prior to commencing the following procedure.

Warning: Firstly, ensure the LMA CTrach™ Viewer has been removed from the airway device. Now use the LMA™ Stabiliser Rod to measure the approximate distance between the proximal end of the ETT and the patient's teeth.

Warning: Do not attempt to intubate through the LMA CTrach™ if the glottis has not first been identified on the Viewer display. After placing a small amount of lubricant on the cuff of the ETT, grasp the device handle with one hand and gently pass the ETT into the Airway tube, rotating it and moving it up and down within the shaft to distribute the lubricant until it travels freely through the entire extent of the tube. Do not, at this time, pass the ETT beyond the 15cm depth marker on the ETT so that the tip of the ETT does not enter the mask aperture. (Figure 9)

Then, after ensuring the patient is well oxygenated, remove the ETT connector, leaving its proximal end firmly attached to the anaesthesia hosing to prevent accidental misplacement and facilitate reconnection. Fully deflate the LMA CTrach™ Airway cuff, making sure the ETT cuff remains inflated. Figure 10: Use the handle to gently lift the device 2-3mm in the direction shown by the arrow as the endotracheal tube is advanced.

Figure 12: Inflate the cuff of the ETT.

10 REMOVING THE LMA CTrach™ AIRWAY PRIOR TO EXTUBATION Remove the Viewer as soon as intubation has been accomplished. Once intubation has been accomplished and the ETT cuff is inflated, a clinical decision must be made whether to leave the LMA CTrach™ Airway in place or remove it. IF AIRWAY IS LEFT IN PLACE, DO NOT LEAVE THE VIEWER ATTACHED TO IT FOR PROLONGED PERIODS WITHOUT MANUALLY SUPPORTING THE DEVICE HANDLE. Figure 9: Hold the device steady while passing the LMA Fastrach™ ETT up and down to lubricate.

Warning: There are reports of pharyngeal oedema and increased mucosal pressure attributed to the rigidity of the airway tube. Therefore, it is recommended that the LMA CTrach™ Airway be removed once intubation has been accomplished. If, however, a clinical decision is made to leave the LMA CTrach™ Airway in place after intubation, the cuff should be deflated to a pressure of 20-30cm H2O and care should be taken to avoid unnecessary movement of the airway tube or movement of the head or neck from the neutral position. There are currently no clinical data on how long it may be left in place once intubation has been accomplished. The procedure for removing the LMA CTrach™ Airway, while keeping the ETT in place, is as follows:

Figure 11: Continue to advance the ETT, while holding the Airway steady, until intubation has been accomplished.

Ease the LMA CTrach™ Airway out by gently tapping or swinging the handle caudally around the chin. This is the reverse of the insertion procedure. Using the curvature of the shaft, swing the mask out of the pharynx into the oral cavity while applying counter-pressure to the ETT with the finger, as shown in Figure 13. When the proximal end of the ETT is level with the proximal end of the metal tube, insert the LMA™ Stabiliser Rod to keep the ETT in place, as shown in Figure 14. Holding the LMA™ Stabiliser Rod, slide the LMA CTrach™ Airway over it until it is clear of the mouth.

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Remove the Viewer from the Airway. Ensure full oxygen saturation is maintained by using the Airway to ventilate the patient. Use only gentle manual lung ventilation to avoid stomach inflation, when using the device in this way. When the patient is optimally ventilated, swing the device outwards about 6cm and reinsert, without deflating the mask cuff (Figure 18). This technique is known as the “updown” manoeuvre. Use the "cm" markings on the Airway tube as a guide. Take care to keep the cuff inflated and do not withdraw the device further than 6cm. LMA™ Stabiliser Rod

LMA™ Stabiliser Rod removed Figure 17: Replace the ETT connector.

Figure 13: Swing the mask out of the pharynx into the oral cavity, applying counter-pressure to ETT with the finger as shown, prior to insertion of the LMA™ Stabiliser Rod.

Figure 15: Remove the LMA™ Stabiliser Rod and steady the ETT at the level of the incisors.

Remove the LMA™ Stabiliser Rod when the LMA CTrach™ Airway cuff is clear of the mouth. Steady the ETT to prevent accidental dislodgment (Figure 15). Caution: Failure to remove the Stabiliser Rod prior to unthreading the Airway over the ETT may result in accidental extubation, or damage to the pilot balloon or inflation line of ETT.

Having replaced the LMA CTrach™ Airway into position in the hypopharynx, re-attach the Viewer to assess the anatomical position, then repeat the intubation attempt if appropriate. If still unsuccessful after two attempts, it may be necessary to use a different size of Airway. However, the manoeuvre described below may be tried before using a different size (see Section 11.2).

Grasp the ETT firmly while gently unthreading the inflation line and pilot balloon from the LMA CTrach™ Airway tube (Figure 16). Now use the LMA™ Stabiliser Rod to check the position of the ETT by again measuring the distance of the proximal end from the teeth. If, during removal of the LMA CTrach™ Airway, any displacement of the ETT has occurred, an appropriate adjustment will need to be made. Replace the ETT connector and ventilate the patient (Figure 17).

LMA™ Stabiliser Rod

Figure 14: Slide the LMA CTrach™ over the ETT and LMA™ Stabiliser Rod until it is clear of the mouth.

11 FAILURE TO VISUALISE THE GLOTTIS USING THE LMA CTrach™ AIRWAY

Figure 16: Remove the LMA CTrach™ completely, gently unthreading the inflation line and pilot balloon of the ETT.

Figure 18: To overcome a downfolded epiglottis, swing the device outwards about 6cm and then replace. a The downfolded epiglottis

11.1 Downfolded epiglottis

b Using the inflated mask as a hook to elevate the epiglottis “up movement”

If the glottic aperture cannot be identified due to a downfolded epiglottis, proceed as follows:

c Replacing mask “down movement”

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11.2 LMA CTrach™ Airway too small or too large

Figure 19: Assistant manipulating the larynx digitally to move it in a cephalad direction (upwards).

visible, try manipulating the larynx digitally to move it in a cephalad direction (upwards), as illustrated in Figure 19; if alternatively the arytenoid cartilages are seen in the middle or upper half of the view, try manipulating the larynx in the opposite direction (caudad or downwards), as illustrated in Figure 20. This manipulation must be performed by an assistant, since the intubator requires both hands to hold the device and advance the ETT when correct alignment is achieved in this way using external digital manipulation of the larynx.

The LMA CTrach™ Viewer and the charger cradle are designed and tested to comply with the Medical Device Directives 93/42/EEC.

If still unsuccessful, the same procedure may be repeated using a larger size, although sometimes a smaller size is needed since this allows more room for the larynx to be manipulated digitally. Note that the larynx is often displaced caudally by one to two centimeters during insertion. This is normal.

THIS PLUG IS NOT WATERPROOF – KEEP DRY DO NOT USE THE CHARGER CRADLE IF THE MAINS LEAD IS DAMAGED OR FAULTY.

12.1.2 Operations

Warning and Caution for AC mains leads

Caution: Always pre-focus the LMA CTrach™ Airway and Viewer, prior to using the LMA CTrach™ system, using the focus wheel (see Sections 7.3 and 7.4).

The LMA CTrach™ Viewer is supplied with an integral medical grade two pin US mains plug and three adaptors suitable for use in the UK, Europe and Australia, for your safety and convenience.

Note: Viewer symbol descriptions are provided in the appendix on page 23. The Viewer comprises a main menu for fundamental Viewer operations and a set-up menu for minor adjustments to the Viewer display.

12.1 Instructions for use

Press the (+) or (-) key to increase or decrease the selected function.

12.1.1 Viewer description for use

The LMA CTrach™ Viewer Main Menu

11.3 Other causes Switch on: Press the (ON/ key once to turn the device on. Inadequate anaesthesia and/or muscle relaxant may cause the glottis to close, preventing entry of the ETT into the larynx.

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1

5 2 6

The presence of lubricant or saliva can obscure the fibreoptic view displayed on the Viewer. Passing a suction catheter through the Airway tube can alleviate this problem.

Switch off: Press the turn device off.

7 8 9

N/ key and hold for 2 seconds to

The light output function allows adjustment of the light output.

3

If the anatomy is likely to be distorted or displaced by tumour, it may be necessary to turn the device handle to the left or right to locate the laryngeal opening. If this manoeuvre is found to be necessary, take care to avoid damaging the fibreoptic channels against the incisor teeth.

Figure 20: Assistant manipulating the larynx digitally to move it in a caudad direction (downwards).

If the LMA CTrach™ is the wrong size, either too large or too small, the proximal tip of the epiglottis only may be visible on the LMA CTrach™ Viewer display, or alternatively the arytenoid cartilages may be located in the middle or upper half of the fibreoptic view. To overcome this problem, it is possible to take advantage of the fact that the larynx is a mobile structure, in the following way: if only the proximal tip of the epiglottis is

Finally, if the glottis is clearly seen but the ETT cannot be made to pass through it, it may be helpful to rotate the ETT gently as it is passed. The straight design of the LMA Fastrach™ ETT facilitates rotation and optimises the chances of passing it through the glottis.

12 LMA CTrach™ VIEWER DESCRIPTION AND INSTRUCTIONS FOR USE Before use Caution: Ensure the Viewer has sufficient battery charge before use. Safety information (suggestions for safety)

The LMA CTrach™ Viewer set-up (configuration) menu Press and hold the “F” key for 5 seconds to switch between the main menu and the set-up menu. Figure 21: Schematic of LMA CTrach™ Viewer

1

Power

2

USB 2.0 Port

3

Focus wheel

4

Battery charge indicator

5

+

Increase selected function

6

-

Decrease selected function

7

F

Function selection

8

ON/OFF switch

9

Battery level indicator

Having entered the set-up menu, the brightness, image colour, image gain, vertical image shift and horizontal image shift functions can be selected by pressing the (F) key. The vertical image shift function enables repositioning of image displayed on Viewer. The horizontal image shift function enables repositioning of image displayed on Viewer. The brightness function allows adjustment of the image brightness.

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The image colour function allows adjustment of the image colour. The image gain function allows adjustment of the image gain detail displayed on the Viewer to be amplified. Note, this digital signal amplification may also increase digital noise and reduce picture quality.

Warning: Failure of any one test indicates that the LMA CTrach™ Airway is damaged or has passed its useful life. The Airway should be replaced.

Detachment: To detach the Viewer from the Airway, simply slide it out and away from connector. Warning: Do not attempt to insert or remove the LMA CTrach™ Airway with the Viewer attached onto it.

12.2 Troubleshooting Description

Possible cause

Action

Poor image quality

Dust or fluid trapped between lenses holder and optical fibres terminal

Check cleanliness of lenses connector

Viewer and Airway are not connected correctly

Check connection between Viewer and Airway

No image or Viewer turns off shortly after turning on

Battery has no charge Electronics circuitry fault

Charge the battery Return Viewer for servicing

Not able to turn on Viewer even after long charging time

Battery has exceeded Return Viewer for usable life servicing Electronics circuitry fault Return Viewer for servicing

12.1.4 Connection to LMA CTrach™ Airway Warning: Do not look directly into the LMA CTrach™ Viewer light source.

Return to default setting. 12.1.5 Device cleaning and disinfection Battery level indicator Fully charged

approximately 30 mins

75% charged

approximately 20 mins

50% charged

approximately 10 mins

25% charged

approximately 5 mins

“Blinking”

No charge

recharge before use

Note:

Version 1.06 - firmware version e.g. 1.06

The Viewer must be disinfected or cleaned between each patient use. Use a soft, non-abrasive moist cloth wetted with dilute (8-10% w/w) sodium bicarbonate solution or mild detergent to gently wipe all the surfaces of the Viewer until all visible contaminant or foreign matter has been removed. Caution: Do not autoclave the Viewer. Electronics components will be damaged by autoclaving conditions.

Note: Viewer software and instructions for installing and using the Viewer software are available as downloadable files in the CD ROM available with LMA CTrach™ kit. The software and accompanying instructions are also available on www.LMACO.com 12.1.3 Preparation for use

Caution: Do not rinse the Viewer under running water or soak it in fluid. The Viewer is not waterproof. Caution: Do not allow any moisture to contact the inner side of the connector socket. The socket contains image and light lenses. Figure 22: Schematic drawing showing the Viewer attachment to LMA CTrach™ Airway.

Note: Before the Viewer is to be used for the first time, fully charge the battery using the charger cradle provided. Before any procedure, it is recommended that the device is checked to ensure that it is operating properly and the battery charge is sufficient. The Viewer may be turned on without being connected to the Airway to check the battery level. If the device can not be turned on, or battery level is too low, use another LMA CTrach™ Viewer for the procedure. Recharge the current one. After ensuring that the battery level is sufficient, connect the Viewer to an LMA CTrach™ Airway. Switch on the Viewer and place a sterile object 1-2 cm away from the viewing window in the EEB. Check that the object is clearly visible and can be brought into focus after suitable focal adjustment. Loss of any part of the image indicates damage to the fibreoptic image path. Poor light transmission may indicate breakage of light-carrying fibres.

No image when Viewer Viewer and Airway are Check connection is turned on not connected correctly between Viewer and Airway

Attachment: The LMA CTrach™ Airway has a rigid connector attached to a fixation post that is welded to the stainless steel Airway tube. Hold the LMA CTrach™ Airway handle firmly while attaching the Viewer. The Viewer is attached to the Airway by slotting the female socket at the bottom of the Viewer onto this connector (Figure 22). The connection is made using a patented magnetic junction which ensures exact alignment of the fibres. Ensure the Viewer has made a positive connection with the Airway. Take care not to allow the Airway to become dislodged by the weight of the Viewer. Switch on the Viewer and adjust the light intensity and focus to obtain optimum image.

Note: After first switching on the Viewer, it takes 5 seconds for the colour temperature of the white light emitter to stabilise.

Caution: Do not wipe the Viewer with a rough cloth, especially on the display surface.

Electronics circuitry fault Return Viewer for servicing Battery is not recharged Cradle is not connected Check connection to after two hours to power supply power supply Viewer is not inserted properly Image is not clear or dark

Check Viewer insertion/position

Light guide fibre broken See preparation for use (section 7) Fluid or lubricant on distal end of the fibres

Clean fibre end inside cuff

Caution: Do not open the Viewer casing as the attempt may risk damaging electronics circuit. Doing so will void the warranty. Caution: If there is damage to the Viewer casing, if fluids enter the casing or if there is corrosion to the battery connector or metal parts, do not use the Viewer. 12.3 Battery indicator and charging The battery charge indicator will only turn on when the device is being charged: - The indicator is red when the device is under charge.

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- The indicator is green when the battery is fully charged. - The indicator is red and blinking when the charging circuit is faulty. (Do Not Use) Charging time for completely uncharged battery is approximately 2 hours. When left in the cradle, the battery will be kept between 90-100% of the full charge. Charging is only possible when the cradle is connected to the power supply and the power indicator on the charger cradle turns green.

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FURTHER INFORMATION

Notes

Laryngeal Mask Anesthesia, Principles and Practice; Second Edition, Joseph R Brimacombe; Saunders, 2004, ISBN 07020-2700-6 Use of the Intubating LMA Fastrach™ in 254 Patients with Difficult-to-manage Airways. Ferson D, Rosenblatt W, Johansen M, Osborn I, Ovassapian A; (Anesthesiology 2001; 95:1175-81) Introduction to the use of the LMA Fastrach™ - Video

Caution: Use only the cradle provided with the device for charging the device. Using a different charger may risk damaging the electronic components in the Viewer and voiding the warranty.

LMA Fastrach™ Instructions for use – Video (Both videos are produced by The Laryngeal Mask Company Limited and are available from your distributor.)

12.4 Storage and Transport An LMA CTrach™ Viewer is supplied together with the charger cradle, LMA CTrach™ Airways (size 3, 4 and 5), and 5 LMA Fastrach™ ETTs (sizes 6,6.5,7,7.5,8 mm) with stabilising rods as a kit. The Viewer may be supplied individually with its charger cradle in a box lined with protective foam. The unit should not be stored at temperatures below -40˚C or higher than 70˚C. The relative humidity must not exceed 95% during storage or use. 12.5 Technical Data

In order to use the LMA CTrach™ safely and effectively, the user must be familiar with the information in this manual and use the LMA CTrach™ accordingly. A copy of the instruction manual is available upon request to: email: [email protected]; Telephone: +44 (0)1534 872555 Inquiries of a technical or medical nature can be addressed to Professional Services: email: [email protected]; Telephone: +44 (0)1534 872555

12.5.1 LMA CTrach™ Viewer specifications Supply voltage Power consumption Display Dimension Weight

6 V DC, 700 mA 900 mAh 86mm colour TFT, 1/4 of VGA (400 x 240 pixels) Height: 80mm, Width: 115mm, Depth: 30mm

200g

12.5.2 Charger cradle specifications: Supply voltage Dimension Weight

100 – 240 VAC, 100 mA Height: 120mm, Width: 110mm, Depth: 65mm

250g

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LMA CTrach™ Airway SPECIFICATIONS

LMA CTrach™ Airway Size

Patient Selection Guidelines

Maximum Inflation Volume (ml)

3 4 5

Children 30-50kg Adult 50-70kg Adult 70-100kg

20ml 30ml 40ml

Authorised EU Representative: LMA Deutschland GmbH, Mildred-Scheel-Strasse 1, 53175 Bonn, Germany Tel +49 (0) 228 1800 180 Fax +49 (0) 228 1800 181 Email [email protected] www.LMACO.com Office Address: The Laryngeal Mask Company (Singapore) Pte Ltd 35 Joo Koon Circle, 629110, Singapore Tel +65 6349 1188 Fax +65 6349 1177 Email [email protected] Manufactured By: The Laryngeal Mask Company Limited Le Rocher, Victoria, Mahé, Seychelles

Copyright © The Laryngeal Mask Company Limited, 2006 Issue: PAK2100003b