Internal use only. Ambu ascope 2. leading the way

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1 Internal use only 2 Ambu ascope 2 leading the way

2 ascope 2 - NOW we can! We listened to the customers and improved the concept using their feedback and our know-how. This is the result: "It went perfectly well this morning in the operating room with ascope 2 in Lyon : a VERY VERY VERY clear picture ; according to Dr. Bauer it looks like an HD image fully comparable to the ones they get with Olympus intubation scope & better than the ones they get with Olympus paediatric. It is a real pleasure to be 200 % confident in the device we present." Maryse Laforgue, West "So far they have intubated 4 patients - the fifth will follow in 45 minutes. 3 oral and 1 nasal were done and the picture is WONDERFUL. Here as well they went several times into a "lake of blood an secretions" and the lense could be cleaned without any problems by just shortly dipping into the muscosa. Kai-Uwe said that it is really a pleasure to be part of this experience." Markus Mauer, Central "The improvement is both dramatic and significant and we can't get this new version soon enough!" David Edwards, UK "ascope 2 Just been used again on an unbelievably difficult airway (oral carcinoma patient). The Anaesthetist was very cruel in that he kept aiming for the worst secretions and STILL could not get them to stick on the lens. His verdict: 'Miles better!'" David Edwards, UK 2

3 ascope 2 updates 8-hour timer Green handle Luer channel for topical anesthesia or oxygen and the ascope 2 is delivered with: New improved camera lens green handle for the doctors to tell the difference between the ascope and ascope 2. With the green handle in their hands they know they have 8 hours usage the oxygen connector in a small pouch fastened to the Luer channel a red foam at the tip of the cord for protection of the camera module 3

4 Connector for air source The main advantages of insufflating air or oxygen through the Luer channel are: it helps clear secretion away from the lens it assists in spraying local anesthetic agent through scopes with narrow channels it delivers oxygen (if oxygen is used) Use of flow through the Luer channel must not exceed 2.2 l/min and may only be used when paying special attention to the risk of increased pressure generated, for example the potential risk of barotraumas to the lungs. Here the connector is placed on the Luer channel and connected to the tube. 4

5 Pro s Con s Prevention of risks Oxygenation of the patient Risk of gastric distension (overinflation of the stomach) Special attention needed when applying airflow Max flow of 2.2 l/min Do not move scope up and down past the oesophagus when utilising the airflow Airflow can help clear secretion off the lens Risk of trauma and rupture of the lungs Special attention needed when applying airflow Max flow of 2.2 l/min Airflow assists in spraying of local anesthesic agent through scopes with narrow channels Risk of subcutaneous emphysema (gas or air present in the tissues underneath the skin) Special attention needed when applying airflow Max flow of 2.2 l/min Do not move scope up and down past the oesophagus when utilising the airflow Oxygen for therapeutic use is not part of the intended use and has never been part of product tests. We should therefore be very careful in our messages. 5

6 Improved camera lens With the first ascope the shape of the lens was concave with an inwardcurving surface. This meant that blood and mucous could get stuck in the small cavity or vault and thus difficult to remove when rubbing the tip against the tracheal mucosa. With the new improved lens a perfectly smooth layer of polymere is placed in front of the inward curving vault. If the lens gets into contact with blood or mucous this will just slip off again or is easily removed by rubbing the lens gently against the tracheal mucosa. The same way as when using a reusable scope. Concave ClearLens Smooth layer of polymere Blood and mucous are difficult to remove Blood and mucous just slip off the smooth surface or are easily removed The optimal focus distance of the camera lens is 1 cm and the camera lens needs time to adjust for light. The best image quality is obtained with as little light around the lens as possible and advancing the ascope 2 slowly up or down. Beware that when preparing the ascope some doctors are lubricating the inside of the ET Tube or lubricating the insertion cord of the ascope. This may result in lubricant on the lens. To clear off the lubricant wipe the lens with gauze or an alcohol wipe and check the image quality at some text. 6

7 8-hour usage time The timer has been prolonged to 8 hours of usage. The timer starts counting from the very first time the ascope 2 is plugged into the monitor. From then and the next 8 hours on there are NO restrictions. The reason that an 8-hour time period has been chosen is that this is the time period Ambu is able to guarantee. Timer Scope symbol will remain green until there are 10 minutes left of the 8 hours and then start changing to yellow and red. Start-up picture Scope time expired Please wait... Icons Ambu ascope Monitor battery icons Fully charged battery (green). Half battery capacity (orange). Low battery capacity (red). Battery error (the power plug is connected but the battery is not charging). Ambu ascope 2 operation time icons Shown on screen from start and until there are 10 minutes left (green). Shown on screen when there are between 10 and 5 minutes left (orange). Time are expiring. Less than 5 minutes left (red). Plug icons Plug is connected and the monitor battery is fully charged (green). Plug is connected and the monitor battery is half charged (orange). Plug is connected and the monitor battery power is low (red). 7

8 Is a suction channel necessary? Some anaesthesiologists never use the suction channel and some do. It is often a matter of habit. In some instances it will be an advantage to have a suction channel but in most instances not: Secretions in the upper airway Issue: Often secretions will accumulate in the upper airway Argument: It is easy to clear the airway by suctioning before the intubation procedure is initiated Secretions in the lower airway Issue: It is often not enough to use the suction channel of the scope because the lumen is too narrow to actually be able to remove all the secretions Argument: The patient can be suctioned through the ET tube as soon as this is in place 8

9 Verification of performance in anesthetised pig Method 3 doctors compared the image quality of the ascope, ascope 2 and the reusable Olympus LF- TP. Each doctor tested altogether 18 randomly chosen scopes. They did not know if they had the ascope or the ascope 2 in their hands. At certain predefined points during the intubation e.g. when standing in front of the vocal cords, they were asked to rate the image quality on a scale from 1-3 with 1 being the best. They were also asked to try to get saliva/secretion on the lens and then to remove it again by gently rubbing the tip against the tracheal mucosa. No. of scopes with no preparation As the scopes were only tested by 3 doctors in 1 pig no statistical conclusions can be drawn but never the less: The pig test verifies that the new lens has the ability to stay clean after contamination with secretion and blood. The performance of the new lens was fully comparable to the lens of the Olympus FL-TP fiberscope. Cleaning the lens against the mucosa was as easy with the ascope 2 lens as with the Olympus FL-TP fiber scope. The overall performance of the ascope 2 lens was fully comparable to the performance of the Olympus FL-TP. No. of scopes with anti-fog spray Compared to the current ascope the new lens is a major step forward and may even bring the ascope to the level of its competitors. No. of scopes ascope ascope Olympus LF-TP Total number tested

10 User Evaluation ascope 2 user evaluation Total Central UK NEM West Number of questionnaires sent out Number of questionnaires received Average image quality of reusable scope normally used Unacceptable, 2 Bad, 3 - Acceptable, 4 Good, 5 Excellent Evaluation of ascope 2 How is the image quality rated during intubation Unacceptable, 2 Bad, 3 - Acceptable, 4 Good, 5 Excellent Evaluation of ascope 2 No cleaning required during the intubation 58.0% 14.3% 55.6% 65.4% 75.0% Cleaning required during the intubation 42.0% 85.7% 44.4% 34.6% 25.0% Evaluation of cleaning of ascope 2 lens during use Cleaning by mucosa Very difficult, 2 Difficult, 3 Same, 4 - Easy, 5 - Very easy Cleaning requirement compared to reusable scope more cleaning, 2 - same cleaning, 3 - less cleaning The above results, based on 50 questionnaires, show that the image quality of the ascope 2 during intubation is almost as good as reusable scopes. 58% did not require any cleaning at all and for the 42% requiring cleaning the amount of cleaning was nearly the same as for reusable scopes. 10

11 What do the Ambu ascope TM 2 and the Personal Computer have in common? "There is no reason anyone would want a computer in their home." - Ken Olson, president, chairman and founder of DEC "I think there is a world market for maybe five computers." - Thomas Watson, chairman They are both great innovative products It took time before their needs were recognized They were born with childhood diseases 11

12 Distributed by Ambu A/S Baltorpbakken 13 DK-2750 Ballerup Danmark Tlf.: Fax: / V01 - Ambu A/S - Technical data may be modified without further notice. PDT and connection to air source are not part of indication for use in the USA.

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