Ambu Aura40 Directions for Use

EN

1. Warnings/Cautions

Throughout these directions for use, appropriate warnings are given describing potential safety hazards associated with use of the Ambu Aura40. WARNING The user should be familiar with the following warnings prior to use of the Ambu Aura40. • The Ambu Aura40 is delivered non-sterile and must be cleaned and sterilized before initial use and before each subsequent use. • Lubricate only the posterior tip of the cuff to avoid blockage of the airway aperture or aspiration of the lubricant. • To avoid trauma, do not use force at any time during insertion of the Ambu Aura40. • Adhere strictly to the recommended cuff inflation volumes as specified in Table 1. Never over-inflate the cuff after insertion. • In case the Ambu Aura40 is used in a fasted patient who may have retained gastric contents, measures should be taken to empty the stomach contents and administer appropriate antacid therapy. Examples include, but are not limited to, moderate obesity and hiatal hernia. • In patients with severe oropharyngeal trauma, the Ambu Aura40 should only be employed when all other attempts to establish an airway have failed. • Use of a nasogastric tube may make regurgitation likely because the tube may interfere with the function of the lower oesophageal sphincter. • The Ambu Aura40 is flammable in the presence of lasers and electrocautery equipment CAUTION • US federal law restricts this device to be sold to or on the order of a physician. • For use only by clinicians trained in the use of an Ambu Aura40. • Ensure that the device is not in any way damaged before use. • Make a brief functional check before using the device. Failure of any one test indicates that the device should not be used. • If airway problems persist or ventilation is inadequate, the Ambu Aura40 should be removed and reinserted or a secure airway established by other means. • Patients should be adequately monitored at all times during use. • The secure function of all anaesthetic breathing system connectors should be checked before the breathing circuit is established. • To minimize contamination, always wear gloves during the preparation and insertion of the Ambu Aura40. • Have a spare Ambu Aura40 ready and prepared for immediate use. • The Ambu Aura40 has not been tested during MRI.

4

492 4610 40 Aura40_V03_0810.indd 4-5

2. Introduction

2.1. Intended use The Ambu Aura40 is intended for use as an alternative to the facemask for achieving and maintaining control of the airway during routine and emergency anaesthetic procedures in fasted patients. The Ambu Aura40 may also be used where unexpected difficulties arise in connection with airway management The mask may also be preferred in some critical airway situations. The Ambu Aura40 may also be used to establish a clear airway during resuscitation in the profoundly unconscious patient with absent glossopharyngeal and laryngeal reflexes who may need artificial ventilation. The device is not intended for use as a replacement for the endotracheal tube, and is best suited for use in surgical procedures where tracheal intubation is not deemed necessary. 2.2. Contraindications The Ambu Aura40 does not protect the patient from the consequences of regurgitation and aspiration. The Ambu Aura40 should only be used in patients, who have been clinically evaluated by a clinician familiar with anaesthesia, as eligible for a laryngeal mask airway. When the Ambu Aura40 is used in the profoundly unconscious patient in need of resuscitation or in an emergency patient with a difficult airway situation (i.e. “cannot intubate, cannot ventilate”), there is a risk of regurgitation and aspiration. This risk must be carefully balanced against the potential benefit of establishing an airway (see the guidelines established by your own local protocol). The Ambu Aura40 should not be used for resuscitation or emergency treatment of patients who are not profoundly unconscious and who may resist insertion.

3. Specifications

0086

The Ambu Aura40 function is in conformity with Council Directive 93/42/EEC concerning Medical Devices. ASTM F 2560-06 Standard Specification for SupraLaryngeal Airways and Connectors. A summary of the methods, materials, data and results of clinical studies that validate the requirements of this standard is available on request, if applicable The Ambu Aura40 is a reusable device, delivered non-sterile. See figure . Ambu Aura40

5

8/23/2010 1:21:24 PM

EN

4. Principles of operation

Mask size #1

#1½

#2

#2½

#3

#4

#5

#6

Patient weight

<5 kg

5-10 kg

10-20 kg

20-30 kg

30-50 kg

50-70 kg

70-100 kg

>100 kg

Maximum cuff inflation volume

4 ml

7 ml

10 ml

14 ml

20 ml

30 ml

40 ml

50 ml

Maximum intracuff pressure

60 cm H2O

 Airway connector

15 mm male (ISO 5356-1)

Min. I.D. Tube

5,2 mm

7,3 mm

8,6 mm

8,5 mm

8,5 mm

9,6 mm

10,6 mm

11,3 mm

Max. O.D. Tube

10,5 mm

13 mm

15 mm

17,5 mm

17,5 mm

20 mm

22,5 mm

25 mm

Luer-connector (ISO 594-1)

Inflation valve Storage temperature Internal volume of ventilatory pathway Pressure drop

10 °C to 25 °C 5,5 ml

8 ml

11 ml

15 ml

16 ml

21 ml

30 ml

36 ml

<1.0 cm H2O at 15 l/min

<0.6 cm H2O at 15 l/min

<0.7 cm H2O at 15 l/min

<0.5 cm H2O at 15 l/min

<1.6 cm H2O at 15 l/min

<0.9 cm H2O at 15 l/min

<0.5 cm H2O at 15 l/min

<0.2 cm H2O at 15 l/min

Min. interdental gap

15 mm

17 mm

19 mm

21 mm

25 mm

29 mm

31 mm

33 mm

Internal pathway

10,3 cm

12,0 cm

13,8 cm

15,9 cm

15,9 cm

17,8 cm

20,0 cm

22,0 cm

Table 1. Specifications for the Ambu Aura40

3.1. Materials The Ambu Aura40 is 100% latex free. The materials used for the product and packaging are: Part  Airway connector / Tube/Cuff  Inflation Valve / Pilot balloon/Manual vent  Pilot tube Packaging - Pouch

Table 2. Material used for the Ambu Aura40 See figure  Ambu Aura40

Material Polysulphone Silicone Polyester/Polypropylene/Nitrile/Stainless steel Silicone Silicone Tyvek/PET/PE

The mask is designed to conform to the contours of the hypopharynx with its lumen facing the laryngeal opening. When correctly inserted, the distal tip of the cuff rests against the upper oesophageal sphincter. The Ambu Aura40 comes in eight different sizes for use in patients of different weight. See table 1 for selection guidelines and max. inflation volumes. Please note that the cuff inflation volumes shown in table 1 are maximum volumes. Applying the stated maximum inflation volume may respond to a cuff pressure above the maximum of 60 cm H2O. It is recommended to continuously monitor the cuff pressure. WARNING Make sure the manual vent is closed during clinical use See figure . Correct position of the Ambu Aura40 in relation to anatomical landmarks. Anatomical Landmarks A – Esophagus G – Hyoid Bone B – Trachea H – Tongue C – Cricoid ring I – Buccal cavity D – Thyroid cartilage J – Nasopharynx E – Laryngeal inlet K – Incisors F – Epiglottis

Aura40 1 – Patient end 2 – Size marking 3 – Ventilatory opening 4 – Ventilatory pathway 5 – Normal depth of insertion marks 6 – Machine end

Table 3. Description of anatomical landmarks and Ambu Aura40 parts

5. Preparation for use

5.1 Cleaning and sterilization Cleaning and sterilization as described below must be carried out before initial use and before each subsequent use as the Ambu Aura40 is delivered non-sterile. The Ambu Aura40 can be used a maximum of 40 times provided the recommended cleaning, sterilization and handling procedures are followed. Proper cleaning and sterilization of the device is essential to ensure continued safe usage up to 40 times. A record card for sterilization of the Ambu Aura40 accompanies every device from delivery. To ensure a proper documentation of the sterilization cycles, the record card should be completed each time the Ambu Aura40 is sterilized. Ambu A/S has validated the instructions provided in 5.1.1. and 5.1.2. as being capable of preparing an Ambu Aura40 for re-use. Any deviation from the instruction provided should be properly evaluated for effectiveness and potential adverse consequences. The cleaning and sterilization instructions in 5.1.1. and 5.1.2 have been validated in accordance with EN ISO 17664 and AAMI TIR 12.

6

492 4610 40 Aura40_V03_0810.indd 6-7

7

8/23/2010 1:21:24 PM

EN

CAUTION Handle the Ambu Aura40 carefully as it is made of silicone, which can be torn or punctured. Avoid contact with sharp or pointed objects. WARNING Do not replace or disassembly any components of the Ambu Aura40 as is may cause product failures. 5.1.1 Cleaning instruction It is recommended to follow the described validated manual or automated cleaning procedure to ensure proper cleaning. It is important to keep the manual vent closed during cleaning to prevent exposure of the inflation valve to any liquid. See figure A. Closed manual vent CAUTION Liquid in the inflation system may cause premature inflation valve failure.

The Ambu Aura40 should be kept moist between the time of use and subsequent cleaning. Remove excess soil with disposable cloth/paper wipe. Thoroughly rinse the Ambu Aura40 in cold running tap water to avoid protein coagulation It is recommended to use one of the two following cleaning methods: A) Manual cleaning Wash the device thoroughly in water using a mild detergent until all adherent visible soil is removed. It is recommended that the Ambu Aura40 is washed with neodisher® MediClean forte (manufactured by Dr. Weigert). The working solution should be prepared by using 30 ml of detergent per litre water. The Ambu Aura40 should be immersed in the working solution and allowed to soak for 15 minutes.

CAUTION All detergents should be used in the recommended dilution/concentration, temperature, water quality (e.g., ph, hardness), and exposure (soak or contact) time, in accordance with the detergent manufacturer’s directions.

To ensure proper cleaning of the airway tube a soft bristle brush is recommended. Brushes should fit tightly, but be able to move back and forth in the area being cleaned. Never use hard brushes or other materials that might damage the silicone cuff or surface. Remove all cleaning residues by thoroughly rinsing the cuff and the airway tube in running warm tap water for 1 minute. Make sure that the water passes through the tube. Closely examine the Ambu Aura40 to ensure that all visible foreign matter has been removed. Repeat the above procedure if necessary. If liquid is noticed in the inflation valve, shake the pilot balloon and tap the inflation valve and manual vent against a towel to remove excess liquid. Dry the device using a soft clean cloth. B) Automated cleaning After rinsing under cool running tap water soak the device in a mild detergent such as Neodischer® MediClean forte (manufactured by Dr. Weigert) or Endozime® (manufactured by Ruhof Corporation). Prepare the solution according to the manufacturer’s instructions using warm tap water and soak for 30 minutes. After soaking place the devices in an automated washer. The following automated cleaning procedure ahs been validated in a STERIS 444 washer Phase

Recirculation time (minutes)

Water temperature

Pre-wash 1

2:00

Cold tap water

Detergent type and concentration N/A

Enzyme wash

2:00

Hot tap water

Neodisher MediClean forte (5/8 fl.oz / gallon water; 38 ml / 5 litre water). Endozime (1 fl.oz / gallon water; 32 ml / 5 litre water)

Wash

2:00

66°C

Neodisher MediClean forte (5/8 fl.oz / gallon water; 38 ml / 5 litre water). Endozime (1 fl.oz / gallon water; 32 ml / 5 litre water)

Rinse 1

0:15

Hot tap water (60°C)

N/A

Table 4. Automated cleaning procedure CAUTION Effective cleaning must be carried out to achieve proper sterilization

After automated washing the device must be removed from the washer and dried with a soft clean cloth. The lumen must be dried using filtered pressurized air. 5.1.2 Sterilization instruction

The only recommended sterilization method is steam autoclaving. Strictly adhere to the following validated instruction to ensure proper sterilization and to prevent damage. The manual vent must be in open position. The Ambu Aura40 should be placed in an appropriate steam autoclave-proof bag before steam autoclaving. Ensure that the pack is large enough to contain the device without stressing the seals.

WARNING Do not use germicides, disinfectants, or chemical agents such as glutaraldehyde, ethylene oxide, phenol-based cleaners, iodine-containing cleaners or quaternary ammonium compounds to clean or sterilize the Ambu Aura40. The material absorbs such substances, resulting in exposure of the patient to potentially severe tissue burns and possible deterioration of the device. Do not use an Ambu Aura40 that has been exposed to any of these substances.

8

492 4610 40 Aura40_V03_0810.indd 8-9

9

8/23/2010 1:21:24 PM

EN

WARNING The manual vent must be open prior packaging for sterilization to avoid irreparable damages to the cuff and pilot balloon. The following sterilization cycle according to AAMI TIR 12 is recommended. Sterilizer type Gravity displacement Dynamic air removal (pre-vacuum)

Preconditioning pulses N.A.

Minimum temperature 135°C

Full cycle time 10 Min.

Minimum dry time 30 Min.

3

135°C

3 Min.

30 Min.

Table 5. Parameters for gravity-displacement and dynamic air removal steam sterilization cycles. The record card should be completed each time the Ambu Aura40 is sterilized. After sterilization the Ambu Aura40 should be stored in accordance with accepted hospital practice. The Ambu Aura40 should not be exposed to direct sunlight or elevated temperatures during storage. Store in unopened pouches at temperature between 10ºC/50ºF and 25ºC/77ºF. 5.1.3 Cleaning and sterilization recommendations Applicable methods  Applicable  Not applicable Ambu Aura40

Cleaning Manual cleaning *

Washing machine *

Sterilization Gravity displacement Dynamic air removal Steam sterilisation (pre-vacuum) ** **

Table 6. Cleaning and sterilization recommendations

5.2.1. Test 1 - Visual inspection Closely examine the Ambu Aura40 for any damage, such as perforation, scratches, blockage, loose parts, etc. Do not use the Ambu Aura40 if it is damaged in any way. WARNING Do not use the Ambu Aura40 if the mask connector does not fit tightly into the outer end of the airway tube. Do not use the Ambu Aura40 if the manual vent does not fit tightly or is disconnected from the pilot balloon. Check that the airway connector on the Ambu Aura40 is fitted tightly to the airway tube. Ensure that it cannot easily be pulled off. Do not twist the connector as this may break the seal. Closely examine the pilot balloon for any damages and make sure that the manual vent fit tightly. 5.2.2. Test 2 - Inflation/deflation test Make sure that the manual vent is closed prior to carrying out this test. Ambu recommends deflating the cuff of the Ambu Aura40 completely. Once deflated, check the cuff thoroughly for any wrinkles or folds. Over-inflate the cuff to the appropriate volume as specified in Table 7. Check that the inflated cuff is symmetrical and smooth. There should not be any bulge nor any sign of leakage in the cuff, pilot tubing or pilot balloon.

WARNING Do not use the Ambu Aura40 if there are any bulges on the cuff or if there are any signs of leakage.

* Specific validated procedures described in 5.1.1 ** Specific validated procedures described in 5.1.2 5.2. Functional testing Functional testing as described below must be carried out before using the device. The tests should be conducted in a manner consistent with accepted medical practice that minimizes contamination of the Ambu Aura40 prior to insertion.

WARNING • Do not use and destroy the device if any one test fails. • Dispose of the Ambu Aura40 in a safe manner according to local guidelines of medical waste.

Mask Size

Over-inflation Cuff volumes

#1

#1½

#2

#2½

#3

#4

#5

#6

6 ml

10 ml

15 ml

21 ml

30 ml

45 ml

60 ml

75 ml

Table 7. Test cuff over-inflation volumes for the Ambu Aura40

CAUTION The inflation volumes specified in table 7 are for testing purposes only. These volumes are not to be used during normal use of the device – the recommended standard inflation volumes can be found in Table 1.

WARNING Make sure the manual vent is closed during functional testing and clinical use CAUTION Always wear gloves during the preparation and insertion of the Ambu Aura40 to minimize contamination. Make sure that the cuff protector has been removed from the cuff

10

492 4610 40 Aura40_V03_0810.indd 10-11

11

8/23/2010 1:21:25 PM

EN

6. Specialized use

6.1. Intubation through the Ambu Aura40 It is recommended to use an exchange catheter for intubation through the Ambu Aura40. A flexible fiberscope can be used through the Ambu Aura40 to view the airway. It is important to pre-oxygenate the patient and to use standard monitoring procedures. Fiberoptic intubation via the AmbuAura40 can be done using an exchange catheter. The Ambu Aura40 is inserted and an exchange catheter is treaded over the fiberscope. The fiberscope is inserted until carina is seen and the exchange catheter is “railroaded” and left in the trachea. The Ambu Aura40 is removed. The ET-tube is put onto the exchange catheter and “railroaded” down into the trachea. The exchange catheter is removed. 6.2 Use of the Ambu Aura40 for blind tracheal intubation There is currently no published data on blind tracheal intubation through the Ambu Aura40. We have therefore no clinical evidence to verify success rate and useful technique. We can therefore not recommend blind tracheal intubation through Ambu Aura40.

6.5 Magnetic Resonance Imaging (MRI) Ambu Aura40 has not been tested for use in MRI scanning. It is therefore not recommended for use with MRI.

7. Manufacturer’s Warranty

The Ambu Aura40 is warranted against material and manufacturing defects for forty (40) uses or a period of one (1) year from date of invoice, whichever comes first, provided that it has been used according to the instruction manual. The completed record card must accompany any Ambu Aura40 returned for evaluation of a defect. Warranty applicable only if purchased from an authorized distributor. Ambu A/S DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY.

6.3. Paediatric use The Ambu Aura40 comes in four different sizes for paediatric patients. See table 1 for selection guidelines and maximum inflation volumes. It is recommended that the Ambu Aura40 in neonates and small children is used by an anaesthesiologist familiar with paediatric patients and already experienced in adult laryngeal mask airway management. The insertion of the Ambu Aura40 in paediatric patients can be performed in the same way as described for adults following either intravenous or gaseous induction. It is important that an adequate level of anaesthesia (or unconsciousness) is achieved before insertion. The insertion should be successful at the same level of anaesthesia that would be suitable for tracheal intubation. Please note that with the Ambu Aura40, as with any form of airway management and anaesthesia in paediatric patients, where ventilation is insufficient, desaturation is likely to occur faster because of the higher oxygen consumption of paediatric patients. 6.4. Critical situations and emergencies 6.4.1. Critical situations The Ambu Aura40 is not intended for use as a replacement for the endotracheal tube. However, in cases where tracheal intubation is not suitable or has failed, the Ambu Aura40 may be used successfully to establish an airway. 6.4.2. Emergencies The Ambu Aura40 may be used during cardiopulmonary resuscitation, either as a temporary rescue airway or as a conduit to intubation. In the resuscitation situation, the patient must be profoundly unconscious with obtunded airway reflexes. The risk of regurgitation and aspiration must be balanced against the potential benefit of establishing an airway and providing oxygenation.

12

492 4610 40 Aura40_V03_0810.indd 12-13

13

8/23/2010 1:21:25 PM