Ambu Airway Management

Transcription

1 Ambu Airway Management

2 Ambu Fields of Excellence Ambu's company philosophy has always been the desire to make life easier for doctors and to find innovative products that can save lives. Innovation and entrepreneurship are key for Ambu. Always have been. Always will be. Anaesthesia With the innovative development of the first self-inflating resuscitator, the Ambu bag in 1956, Ambu forever changed the history of saving lives. Now more than half a century later we are still dedicated to the development of innovative products that help save lives and simplify workflow and the daily life of the anaesthetists to the benefit of the patients. Within the field of anaesthesia Ambu offers a wide range of products from resuscitators, face masks and laryngeal masks to the highly innovative single-use flexible video scope. Products that all have their own place in the difficult airway algorithm. Emergency Care We consistently focus on developing new devices to improve patient care and make the work of our customers easier. In the field of emergency care we offer a broad assortment of products, from resuscitators, suction pumps and CPR barriers to our well-known training manikins and immobilisation devices. Patient Monitoring & Diagnostics In 1971, a Danish engineer by the name of Jan Rasmussen recognized the need to obtain reliable traces from biosignals. Since then we have been leading the way in the design and development of high quality single-use electrodes for accurate diagnosis. Ambu offers a complete range of electrodes for different applications to meet your needs. Ambu past, present and future Ideas may be conceived in one person s head, however, it takes a collaboration of minds to see them evolve into real products. Since 1937, we have been leading the way in healthcare. We develop ideas whether they arrive through meticulous research or by a clever question asked by a customer. All that matters is that we transform ideas into efficient solutions that work to our customer s advantage and improve patient safety. We listen to your needs Our desire to listen to the needs of healthcare professionals has been the driving force behind the development of the Ambu bag, the Blue Sensor electrodes or the world s first single-use videoscope, the ascope. Ambu devices are used every day to rescue, revive, diagnose, monitor or train. We are proud of this. But our products do nothing on their own. They are only useful in the skilled hands of doctors, nurses and paramedics around the world. The next decade Our customers tell us that they need reliable high-quality products ready for immediate use. They expect excellent service and on-time delivery. They need innovation to help improve patient outcomes and optimise efficiency. They want training and clinically meaningful evidence. Above all, our customers want us to truly understand the challenges of their patient care and to collaborate on the development of future solutions. We are determined to continue to develop best-inclass products and the services you expect for your work each and every day. We do it now and we will do so for many decades to come. Ambu's commitment to quality Ambu products are designed and manufactured to comply with all relevant internationally recognised standards. Our entire organisation is committed to providing products that match the high expectations of users and patients, fully meet the requirements defined by standards and guidelines. The Ambu quality management system operates under ongoing consideration for maintaining ISO quality management system certification, and is subject to regular inspections by the regulatory authorities in compliance with the international standard for medical device manufacturers. Our commitment to quality includes an ongoing effort to improve on feedback, and forward product requests from our customers. 2 3

3 Index Suggested clinical procedure Primary Clinical Setting Laryngeal Masks 6 Ambu AuraOnce 8 Ambu AuraStraight 9 Ambu AuraFlex 10 Ambu Aura-i 11 Ambu AuraGain Ambu Aura40 13 Ambu Cuff Pressure Gauge 14 Face Masks 15 Ambu UltraSeal 16 Ambu Disposable 17 Ambu King Ambu Silicone 19 Ambu Open Cuff 20 Resuscitators 21 Ambu SPUR ll 22 Ambu Oval Silicone 23 Ambu Oval Silicone Plus 24 Ambu Mark IV 25 Ambu Peep Valves 26 Ambu Pressure Manometer 26 ET Tube Holder 27 Breathing Bags 28 King Breathing Bags 29 Reusable resuscitator - Spare parts 30 Technical Specifications 33 Laryngeal Masks 33 Face Masks 31 Resuscitators 32 Breathing Bags 46 Order Information 48 Laryngeal Masks 48 Face Masks 49 Resuscitators 51 Breathing Bags 54 Please note that product availability may vary from country to country. Please contact Ambu for further information. 4 5

4 Laryngeal Masks Ambu AuraOnce Ambu developed the first single use, anatomically curved laryngeal mask, the Ambu AuraOnce. A laryngeal mask that is single-moulded, with a reinforced tip and printed information on the pilot balloon. The AuraOnce has been tested in various studies. During a Meta-analysis, where the AuraOnce was compared with other first generation laryngeal masks in adult sizes. It demonstrates higher sealing, ease of insertion and less traumatic 1. This gives clinicians the confidence to ventilate the anaesthetised patient without harm and unnecessary use of time. For the paediatric sizes, the AuraOnce perform nicely with a fast insertion, a high first attempt success rate together with a high overall insertion success rate. Furthermore, the laryngeal mask stays in place after insertion even without forcing it down with the use of tape 2. By choosing the AuraOnce as a first Generation laryngeal mask for patients undergoing general anaesthesia, you will get a safe and cost-efficient laryngeal mask, when comparing key performance parameters against several other supra glottis airway devices 3. Ambu AuraStraight The AuraStraight was designed for use in the anaesthesia department; with the well-known 1st generation straight form, it provides users with the choice between curvatures. AuraStraight comes in a full range of 8 sizes from neonate to large adult. The reinforced tip and EasyGlide surface aids the ease of insertion end extraction. Ambu AuraFlex The Ambu AuraFlex with wired tubing designed specifically to avoid occlusion of the airway tube, when used for certain special procedures. The pilot balloon attaches all the way to the connector part of the laryngeal mask, preventing interference in the surgical area. The AuraFlex is tested to support surgery at the ENT department including tonsillectomy with the use of gag 4 as for surgery in near face area, where the laryngeal mask tube and head changes position during surgery. The seal performance and the endoscopic view has shown to be better in different head positions with the Ambu AuraFlex than with a general first generation laryngeal mask 5. AuraGain The 2 nd generation laryngeal mask, Ambu AuraGain, facilitates gastric access in all sizes, with a size 16 Fr in adult laryngeal masks. A high sealing (up to 40 cmh2o) performance, has already been tested in the evaluation 10. The wider inner diameter combined with shorter airway tube, supports intubation and bronchoscopy diagnostic procedures. The AuraGain laryngeal mask can be used, for almost every laryngeal mask procedure and will take you to the next level. Studies using the AuraGain in gynaecologic laparoscopy and laparoscopic cholecystectomy shows high airway sealing when the patients head is placed in different position and a non-obstructed epiglottis view tested with a flexible bronchoscope, this places AuraGain among the very best performing 2 nd generation laryngeal masks on the market 11. Ambu Aura product selection table AuraOnce & Aura Straight ASA 1-2 ENT Head movement x AuraFlex x x Bronchoscopy AuraGain can be used for a variety of planned and rescue procedures in the paediatric airway management. The high sealing performance, ease of placing gastric tube and low post-operative complications 13 gives you several reasons to choose AuraGain in the paediatric setting. Ambu Aura40 The Ambu Aura40 is the world's first reusable laryngeal mask to feature a built-in curve that carefully replicates natural human anatomy. This curve is molded directly into the tube so correct insertion is easy without abrading the upper airway. Our unique curve also ensures that the patient's head remains in a more natural position when the mask is in use without extra stress on the upper jaw. Moreover, Aura40 is specially designed to give the airway tube the flexibility needed to adapt to individual anatomical variances and a wide range of head positions. Difficult airways/ Emergency Laparoscopic procedures Higher ventilation pressure Aura-i x x (x) AuraGain x x x x x x Ambu-i The Ambu Aura-i, is a laryngeal mask with a wider inner diameter combined with a shorter airway tube and biteblock. It has been designed to facilitate the difficult airway and emergency situations, and can be used as an everyday device with intubation capability. The Aura-i facilitates intubation with standard tubes due to the shorter airway tube. The recommended tube size can be seen on device after insertion. Furthermore, the Aura-i can remain in place after intubation, just take out the air of the cuff to avoid trauma and you will have the opportunity to perform a controlled awakening and extubation. The Aura-i has a higher sealing performance than first generation laryngeal masks in tests and together with a high first attempt success rate during flexible intubation you get safety and certainty in emergency situations 6. The wider inner diameter is a benefit in bronchoscopy diagnostics procedures like EBUS and TBNA and makes it possible to ventilate and perform bronchoscopy at same time. The diagnostic procedures can be done in combination with deep sedation techniques, giving a fast recovery time without increased pain 7. During paediatric cardiopulmonary resuscitation, laryngeal masks are mentioned as an alternative to intubation in the ERC 2015 guidelines. Test of the Aura-i has shown to be useful for airway management during chest compression in children 8, furthermore flexible scope assisted intubation through the Aura-i has been verified down to the size 1½ laryngeal mask used in children of 1 month of age 9. (x) no gastric access Ref. list: 1. Comparative efficacy and safety of the Ambu AuraOnce laryngeal mask airway during general anaesthesia in adult; a systematic review and metaanalyse. Baidya, Chandralekha, Darlong V, Pandey R et al. Anaesthesia 2014 Sep; 69(9): Performance of the pediatric-sized i-gel compared with the Ambu AuraOnce laryngeal mask in anesthetized and ventilated children. Theiler LG, Kleine- Brueggeney et al. Anesthesiology 2011 Jul; 115(1): Is the lowest price material the better cost efficacy choise? Weil G et al. Ann Fr Anesth Reanim Sep-Oct; 33 (9-10), Article in French. 4. Comparative two center study of single use Auraflex versus LMA flexible disposable supraglottis airways in adults undergoing ENT surgery. Grush, Raga, Janderwerth, Hinkebein et al. Anaesthesia, Jan Clinical and endoscopic comparison of the single use laryngeal mask (AuraFlex) in 3 different positions of the head. M. Eric, G. Antonio, B Ester. Eur J Anasthesiol 2008; 25(Suppl 44): 10AP The use of the Ambu Aura-i supraglottic airway in an isga-first rescue strategy. Søren B. Laursen, Frank Samsøe Jensen et al. Chicago ASA 2011 A Flexible bronchoscopy through laryngeal mask Ambu Aura-i for diagnostic procedure. Nella A et al. ESA 2014 Stockholm. 8. Simulation analysis of three intubating supraglottic devices during infant chest compression. Kohama H, Komasawa N et al. Pediatr. Int 2015 Feb; 57(1): A Randomized trial comparing the Aura-i with the air-q intubating laryngeal airway as conduits for tracheal intubation in children. Narasimhan Jagannathan, Lisa E. Sohn, Amod Sawardekar et al. Pediatric Anesthesia 22 (20) Multicenter evaluation of the Ambu AuraGain in normal airways. auragain.aspx 11. Comparison of Ambu AuraGain vs LMA Supreme in patients undergoing gynaecologic laparoscopy Lopez A, Martinez-Camacho A et al.. Role of laryngeal mask airway in laparoscopic cholecystectomy. José M Beleña, Ernesto Josué Ochoa et al. World J Gastrointest Surg Nov. 27, 7(11): A randomized comparison of the Ambu AuraGain and the LMA Supreme in infants and children. Jagannathan N, Hajduk J., Sohn L et al. Anaesthesia 2016 Feb; 71(2) :

5 Ambu AuraOnce Ambu AuraStraight Ambu AuraOnce is the ideal 1. generation laryngeal masks for achieving and maintaining control of the airway during routine and emergency anaesthetic procedures in fasted patients. It is also an excellent option when unexpected difficulties arise in connection with airway management. Available in eight convenient sizes. The Ambu AuraOnce features a special 70 curve that carefully replicates natural human anatomy. Moulded directly into the tube for additional safety, the unique shape of the mask makes correct insertion fast and easy without putting extra stress on the upper jaw. Moreover, like all Ambu laryngeal masks, AuraOnce has a higher oropharyngeal seal pressure to ensure reliable ventilation. AuraOnce has also proven to be particularly useful in establishing a clear airway during resuscitation in profoundly unconscious patients with absent glossopharyngeal and laryngeal reflexes who may need artificial ventilation. The Ambu AuraStraight provides users with an even greater choice and an alternative to the already popular AuraOnce curved laryngeal mask for use both in anaesthesia and emergency medicine. Ambu AuraStraight comes in a full range of 8 sizes from neonate to large adult. Reinforced tip resists folding over during insertion and plugs the upper esophageal sphincter Convenient depth marks for monitoring correct position of the mask Ergonomically shaped airway tube for firm and ergonomical grip during insertion Soft cuff ensures a good seal with low mucosal pressure Reinforced tip resists folding during insertion and plugs the upper esophageal sphincter Cuff and airway tube moulded as single unit for extra safety no separation Pilot balloon identifies mask size and provides precise tactile indication of degree of inflation Convenient depth marks for monitoring correct position Packaged sterile and ready for use in colour-coded pouches MR safe Phthalate-free material. Does not contain natural rubber latex Cuff and airway tube moulded as single unit for extra safety - no separation The surface has an EasyGlide texture to ease insertion Extra soft cuff ensures the best possible seal with least possible mucosal pressure Less invasive than endotracheal tube Pilot balloon identifies mask size and provides precise tactile indication degree of inflation Packaged sterile and ready for use Colour coded pouch with directions for use Available in 8 sizes fitting a wide range of patients MR safe and compatible Phthalate-free material. Does not contain natural rubber latex 8 9

6 Ambu AuraFlex Ambu Aura-i Ambu AuraFlex is a disposable, flexible laryngeal mask which is specially designed for ENT, ophthalmic, dental and other head and neck surgeries. The challenge of a flexible laryngeal mask is the combination of needs: the ease of insertion and security of the airway needed by the anaesthesiologist, the flexibility and room to work needed by the surgeon and the need to protect the patient from residual proteins. Ambu AuraFlex combines these needs in an innovative, single-use solution. Ambu Aura-i is a disposable laryngeal mask designed for everyday use. Pre-formed to follow the anatomy of the human airway, the soft rounded curve of the Aura-i ensures fast and easy placement and guarantees long-term performance. Aura-i is the preferred everyday routine device for establishing an airway where an ET-tube is deemed unnecessary.in case of a change in surgery procedure, where the end-game is to intubate the patient, Aura-i can be used as conduit for direct endotracheal intubation assisted by a flexible scope (such as the Ambu ascope 3). The airway tube is designed to allow easy passage of an appropriately sized ET-tube. Can stay in after intubation, just deflate cuff and continue ventilation on ET Tube. Aura-i comes in a complete range of 8 sizes, suitable for infants, pediatrics and adults. High flexibility of the reinforced airway tube enables positioning away from the surgical field without loss of seal Integrated pilot tube eases the surgeons work and reduces the risk of cutting the pilot tube during surgery Kink-free wire-reinforced airway tube eliminates the risk of airway tube occlusion Full range from size 2 through size 6 - widest range of possible uses Thin and soft feel of the cuff with EasyGlide surface for easy and smooth insertion and removal Reinforced tip eases insertion and prevents folds during insertion - easy, fast and accurate positioning Depth marks for visual control of correct positioning of the mask Packaged sterile and ready for use Colour-coded packaging with directions for use Phthalate-free material. Does not contain natural rubber latex Built-in anatomically correct curve for fast and easy insertion Intubating capability using standard ET-tubes Reinforced tip resists folding over during insertion and plugs the upper esophageal sphincter Bite resistance in the connector block prevents occlusions Convenient depth marks for monitoring correct position Pilot balloon identifies mask size and provides precise tactile indication of degree of inflation Navigation marks for guiding flexible scope Color-coded packaging with directions for use MR safe Phthalate-free material 10 11

7 Ambu AuraGain Ambu Aura40 Ambu AuraGain is the only anatomically curved SGA with integrated gastric access and intubation capability in all sizes, taking patient safety and airway management efficiency to a new level. The AuraGain is Ambu s 2nd generation laryngeal mask, satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. Ambu Aura40 is a reusable laryngeal mask for everyday use. Aura40 has a special curve that carefully replicates natural human anatomy. Molded directly into the tube, the unique shape makes correct insertion fast and easy. Aura40 s curve also ensures that the patient s head remains in a more natural position when the mask is in use without extra stress on the upper jaw. Moreover, Aura40 is specially designed to give the airway tube the flexibility needed to adapt to individual anatomical variances and a wide range of head positions. Aura40 features our special reinforced tip, which helps prevent folds during insertion that can cause improper positioning and possible airway leak. In short, positioning is fast and accurate, each and every time. Integrated gastric access channel for managing gastric content The original anatomical curve, ensuring rapid placement Intubating capability using standard ET-tubes Integrated bite absorption area prevents airway occlusion Pilot balloon identifies mask size and provides tactile Indication of degree of inflation Navigation marks for guiding flexible scope MR safe Phthalate-free material. Does not contain natural rubber latex Built-in anatomically correct curve for fast and easy insertion Reinforced tip resists folding over during insertion and plugs the upper esophageal sphincter Color-coded pilot balloon identifies mask size and provides precise tactile indication of degree of inflation Ergonomically shaped for firm grip during insertion Cuff and airway tube molded as single unit for extra safety - no separation Extra soft cuff ensures the best possible seal with least possible internal pressure Convenient depth marks Does not contain natural rubber latex Autoclavable up to 40 times 13

8 Ambu Cuff Pressure Gauge Face Masks Ambu has a long history in the production and selling of quality masks for use both within the hospital and pre-hospital area. All Ambu face masks are compatible with the different models and sizes of our resuscitators. There are several options for choosing the correct face mask according to the needs of the user and the patient. Ambu offers a fully transparent, reusable and disposable version of the classic blue silicone masks. The masks are typically used to support ventilation during the preparation of anaesthesia of the patient for the operation. They have always been a great addition to the already existing Ambu resuscitators. Quality, effectiveness and comfort is recognised by all users. Ambu has expanded with the acquisition of King Systems. Ambu King Masks are designed for comfort and safety, and are "The leading mask design. The edge is extremely flexible and feels sticky for excellent seal on the patient. These masks are superior in all shapes and sizes. The Ambu Cuff Pressure Gauge is designed to inflate and monitor the pressure of laryngeal masks and intubation tubes with low-pressure cuffs. The dial has two zones of measurement graded in cm H 2 O with colour coding for optimum visibility. The Luer connection allows the gauge to be connected to laryngeal masks or intubation tubes, either directly or via the connecting tube. The Ambu Cuff Pressure Gauge has an ergonomic design and is easy to operate thanks to the integrated inflation bulb and release valve. It addresses the particular needs of anaesthesia and resuscitation services. The Ambu disposable or UltraSeal face masks meet all-important features that users need, providing an airtight seal with minimal applied pressure. The mask is transparent for visual inspection of bleeding, vomiting and spontaneous breathing. The design and the shape of the cap is assured to support user manipulation during long-term ventilation. All our masks conform to the ISO rules relation to the size of the connections, and are compatible with all models of ventilation balloons on the market. Simple and robust design Compatible with all Ambu laryngeal masks H 2 O graded in cm Easy-to-use inflation bulb and release valve Large dial for optimal display Standard Luer connector Phthalate-free material. Does not contain natural rubber latex 14 15

9 Ambu UltraSeal face masks Ambu Disposable face masks The Ambu UltraSeal face mask is an anatomically correct disposable face mask designed specifically for anaesthetic departments. It is a single use disposable face mask that comes both with and without a check valve. Sizes 3, 4, 5 and 6 come with a hook ring for attachment of the mask with a strap. The current range consists of 4 paediatric sizes, and 3 adult sizes up to size 6 Large Adult. The Ambu disposable face mask is an anatomically shaped mask designed for use with manual and automatic fans and ventilators. The mask comes in an assortment of 6 different sizes, and comes with or without a control valve, providing a good seal and minimum pressure on the patient. Transparent and crystal clear dome secures easy observation of the patient s condition during use Very soft anatomically shaped cuff that enables a tight seal with a minimum of pressure applied. Colour code on the package for quick and easy size identification All sizes are individually delivered in a clean medical box of 20 pieces total, or as single units. Hook ring on all versions apart of the neonate and infant dimensions. The hook ring can simply be removed if not needed Phthalate-free material. Does not contain natural rubber latex Thumb Support for user convenience Soft, moulded, air filled edge to tightly fit on the face of the patient Crystal clear dome for easy observation of the condition of the patient For use with a single patient. Time-consuming cleaning, sterilisation and disinfection procedures are not necessary. The potential risk of cross infection is excluded. Hook ring on all versions apart from the neonate and infant dimensions. The hook ring can be removed if not needed Phthalate-free material. Does not contain natural rubber latex 16 17

10 Ambu King Mask disposable face masks Ambu Silicone face masks Because of the innovative quality design of the Ambu King Mask, it is the market leading anaesthesia mask design available today. The Ambu King Mask has a thin and tacky cuff which improves the ability to create a ventilation seal on a variety of patients. The design with rounded edges secures a smooth grip and user comfort. The Ambu King Mask is made of phthalate-free PVC material for patient and user safety. Furthermore, the Ambu King Mask can be used in a MR environment, as it is MR Safe. The Ambu King Mask is also available in a scented version with Fresh Scent, Bubble Gum, Strawberry and Cherry scents. The Sweet Dreams masks release soothing aroma from natural oils in mask cushion. The Ambu Silicone Face Mask is designed for use with manual and automatic resuscitators and ventilators. Ambu Silicone Face Mask is self-inflating for an easy and tight seal. The cuff pressure may be regulated (except for mask size 0A). Cushion is extremely pliable and tacky to the touch, for an excellent face seal Anatomically shaped cuff enabling a tight seal with minimum applied pressure Clear dome for easy observation of the patient s condition Ribbed on top of the cushion, for a no-slip grip Flexible, self-expanding dome Color-coded hook rings for easy size identification* *Not available for sizes 1 and 2 Transparent dome for visual check of bleeding, vomitus and spontaneous breathing Thumb rest for a tight, easy seal Comfortable design and texture The buttoned-on cuff enables easy removal for cleaning Can be autoclaved repeatedly at 134 C (except size 0A) Available in 7 sizes Size 0 with boring impedes ventilation pressures higher than approx. 40 cm H2O, enabling the user to administrate correct ventilation on small children with a body weight of at least 15 kg (3 years) 19

11 Ambu Open Cuff Silicone face masks Resuscitators With the innovative development of the new selfinflating "Ambu bag" in 1956, Ambu has forever changed the history of resuscitation. Today, after more than half a century, Ambu is still involved in the development of innovative products that help save lives and simplify working conditions for anaesthetists and the benefit of patients. In the field of airway management Ambu offers a wide range of products, from the resuscitator, face masks and laryngeal masks to flexible disposable videoscopes and video laryngoscopes. These products all have their place in the difficult airway algorithm. Mark IV - reusable Mark IV are available in two sizes: The Ambu Mark IV Adult designed for manual ventilation of adults and children with a body weight of down to approximately 15 kg (3 years), and the Ambu Mark IV Baby for infants and children with a body weight of up to about 20 kg (4-5 years). 100 % latex-free Mark IV gives you exceptional visual and tactile lung condition feedback during manual resuscitation, making operation safer and more secure. Oval - reusable Ambu Open Cuff Silicone Face Masks have been designed by paying special attention to creating a comfortable fit, both for adults and children. The Open Cuff Silicone Face mask can be used with both manual and automatic resuscitators, and the silicone s transparency provides good visibility of the patient during use. The small round sizes have been specifically developed to fit the facial anatomy of children. All masks in the range are made of soft silicone, are reusable, and can be autoclaved at 134. SPUR ll - disposable Working with the Ambu bag, Spur II, gives you the opportunity to handle an emergency situation fast and safe. The Ambu Spur II has a single-shutter valve for reliable functionality vs. more common duck bill valve. Duck Bill valve is more sensitive to fluids and humidity as it uses two thin disc valves instead of single valve. The single-shutter valve contains the valve housing, one valve disc and the expiration connector. Ambu Oval and Oval Plus Reusable Resuscitator offers you an up-to-date reusable resuscitation bag for manual ventilation of all your patients from neonates through to adults with improved recoil time and enhanced size and grip properties. It provides you with a range of benefits that will help you in your daily work and increase your patients safety. Transparent for visual check of bleeding, vomitus, and spontaneous breathing An optimized shape in a phtalat-free material, ensures the best recoil time and superior control. We included the safe-grip surface and handle for ease of use. Spur II is disposable, as requested, to avoid all cross contamination risks. Available in 6 different sizes All models can be autoclaved repeatedly at 134 C 20 21

12 Ambu SPUR II disposable resuscitator Ambu Oval Silicone reusable resuscitator The invention of the "Ambu bag" resuscitator in 1956 started Ambu on it's continuous journey developing products that others may not consider possible. Today the term "Ambu bag" is used all over the world as a generic term for a resuscitator, however only Ambu manufacture the real "Ambu bag" The Ambu SPUR II (Single Patient Use Resuscitator) is designed for manual ventilation of neonates through to adults with M-Port for direct capnography recording and posibility of direct attachment of PEEP valve and Manometer, without interuption of ventilation or additional connectors. The Ambu Oval Silicone resuscitator has been designed for the manual ventilation of neonates through to adults. It is a reusable silicone resuscitator. The textured surface of the silicone resuscitators combined with the unique support strap ensures that a comfortable and firm grip is guaranteed, allowing for effective ventilation over extended periods, without the problem of hand fatigue. A pressure limitation valve is optional for the adult version and has been included into the design of the paediatric versions to ensure the safety of the patient.* * International guidelines recommend that all manual resuscitators for infant and pediatric patients should be equipped with a pressure limitation mechanism so the airway pressure does not exceed 45 cm H2O. DIRECT etco 2 Capability (sidestream) Integrated handle for reliable functionality Features our SafeGrip surface to ensure a secure grip onto the bag Unique shape is small and easy to hold. The ergonomic, lightweight design of Ambu SPUR II is made for optimal user handling and support even during extended ventilations Phthalate-free material. Does not contain natural rubber latex Reduced fatigue during manual ventilation Ergonomic bag design secures optimal user handling and support during extended ventilation. The bag has superior surface and grip properties. The hand strap ensures a good grip, which helps to reduce fatigue during manual ventilation; also for users with small hands. Ambu Oval Silicone Resuscitators is easy to disassemble. An effective procedure for cleaning and sterilization can be used. Can be autoclaved at 134 C. Low weight Optimal user handling and support during extended ventilation. The patient valve with swivel enables free positioning of the bag without removing the mask from the patient

13 Ambu Oval Plus Silicone reusable resuscitator Ambu Mark IV reusable resuscitator The Ambu Oval Plus version is a standard Ambu Oval Silicone Resuscitator, with a Mark IV inlet valve. Thus the entire unit is compatible with Mark IV. The resuscitators are semi-transparent allowing for a visual check of the patient s condition. Ambu Oval Plus Silicone Resuscitators are designed for manual ventilation of paediatrics through to adults. The textured surface of the silicone resuscitators combined with the unique support strap ensures that a comfortable and firm grip is guaranteed, allowing for effective ventilation over extended periods, without the problem of hand fatigue. The resuscitators are semi-transparent allowing for a visual check of the patient s condition. A pressure limitation valve is optional for the adult version and has been included into the design of the paediatric versions to ensure the safety of the patient.* * International guidelines recommend that all manual resuscitators for infant and pediatric patients should be equipped with a pressure limitation mechanism so the airway pressure does not exceed 45 cm H2O. Available in two sizes, the Ambu Mark IV Adult and Mark IV Baby resuscitators are easy to hold, easy to use and completely autoclavable for reuse. Designed in accordance with the original double wall principle, the new 100 % latexfree Ambu bags are more robust and provide users with exceptional visual and tactile lung condition feedback during manual resuscitation, making operation safer and more secure. Built-in pressure limitation prevents compression if there is any resistance in the patient s airways. Both Mark IV Adult and Baby are made of silicone rubber and are 100 % latex-free. Both sizes feature a swivel between the patient valve and the mask, as well as between the valve and bag, making it possible to change positions or switch hands without interrupting patient ventilation. Reduced fatigue during manual ventilation Ergonomic bag design secures optimal user handling and support during extended ventilation. The Ambu Oval Silicone resuscitator is easy to disassemble. An effective procedure for cleaning and sterilization can be used. Can be autoclaved at 134 C. Double wall bag provides built-in pressure limitation for patient safety Unique single-shutter valve system for reliable functionality Integrated handle for user comfort and uniform compression Entire Mark IV resuscitator, including the closed reservoir, can be autoclaved at 134 degrees. Closed reservoir also suitable for Mark IV Baby Pressure-limiting valve with override cap on Mark IV Baby for added infant protection The bag has superior surface and grip properties. The hand strap ensures a good grip, which helps to reduce fatigue during manual ventilation; also for users with small hands. Low weight Optimal user handling and support during extended ventilation. The patient valve with swivel enables free positioning of the bag without removing the mask from the patient

14 Ambu PEEP Valves Ambu ET Tube Holder Ambu PEEP Valves are designed for use with manual resuscitators or ventilators, where specified by the manufacturer. Positive End Expiratory Pressure is in general used to maintain adequate oxygenation of the blood. PEEP is more specific recommended in assisted ventilation of preterm infants. MR conditional, up to 3 Tesla (only disposable PEEP valve) Ambu PEEP Valves have been designed to provide unique resistance characteristics when used with manual resuscitators, ventilators, anaesthesia machines and CPAP systems where specified by the manufacturer Ambu PEEP Valves can be fitted directly to the patient valve of any original Ambu resuscitator without additional connectors The Ambu endotracheal tube holder is designed with a quick connect ratchet system that allows a fast and secure fixation of the endotracheal tube after insertion into the trachea, even using only one hand. It has an integrated bite block to ensure no additional equipment needs to be used for the intubation. The patient cannot bite on the endotracheal tube so the intubation is safe. As a single patient use product the Ambu ET Tube Holder minimizes the risk of cross infections. The Ambu ET Tube Holder is easy to use and can be placed on patients needing a 3 mm - 9 mm ET Tube. It can be use on both adults and children. The Ambu ET Tube Holder is available with a rubber strap or soft Velcro strap Ambu Disposable Pressure Manometer The Ambu Disposable Pressure Manometer for single patient use is intended to be used for monitoring the patient's airway pressure. The Ambu Disposable Pressure Manometer is suitable for use with Ambu resuscitators or other resuscitators, hyperinflation bags, CPAP masks or circuits. Designed to secure the ET tube in place after insertion in the trachea Comfortable closed cell foam padded backing Eliminates the need for tape and timely taping procedures Integrated bite block Quick Connect Ratchet System Non-latex strap with strap inducer for easy application around head MR and CT Scan safe Latex and PVC free The slim design makes it easy to monitor pressure with minimum obstruction of the view of the patient s face As a single patient use product, the Ambu Disposable Pressure Manometer minimises the risk of cross infections Phthalate-free material. Does not contain natural rubber latex The manometer has a colour coded scale to give enhanced visual support during ventilation. The colour coding scale is only for visual support. The correct ventilation pressure must be determined by the medical professional 26 27

15 Breathing Bags King Breathing Bags King Breathing bags are designed with the clinician in mind. The shape and the tri-pleat design offers a better fit to a range of hand sizes and improves the grip around the bag. The hourglass-shaped Contour breathing bag even further reduces hand fatigue. The thin yet durable latex-free material provides the clinician with an excellent feel for lung compliance during ventilation. King Breathing bags come in a standard green colour. But it is also the only breathing bag in the market currently that has a range of coloured breathing bags, targeted towards paediatric population. With the Rainbow Breathing Bags children can pick their colour of choice and this can create a calming effect before induction. King Breathing bags include a complete range of latexfree bags in sizes 0,5 ltr, 1,0 ltr, 2,0 ltr and 3,0 ltr with different types of connectors in compliance with ISO regulations. The Rainbow Breathing bags are a colourful option for infants and children. In addition to pediatric anesthesia breathing bags, the Contour breathing bags with an hourglass shape provide a better fit and grip. Thin yet durable design Five standard sizes offer a bag to fit any patient The hourglass-shaped Contour breathing bag reduces hand fatigue Tri-pleat design offers a better fit Thin and durable surface maximizes clinician feel and ability to assess patient lung activity The hourglass-shaped Contour breathing bag efficiently delivers required gas volume 28 29

16 Ambu Reusable Resuscitator Spare Parts Oval Silicone Plus Oval Silicone Description Item number 1 Outlet cap (option) Expiratory connector Valve disc for patient valve (set of 10) Patient valve housing with pop-off valve Adult patient valve with pressure limiting valve complete Adult patient valve complete Adult Bag Valve disc small Flange nut Available in Override cap Adult patient valve housing Inlet valve housing Inlet valve housing cover Reservoir housing Reservoir cap Ambu Mark IV inlet valve complete Reservoir bag Reservoir bag complete Extension tube with 2 connectors, Length 30 cm Extension tube with 2 connectors, Length 90 cm Extension tube with 2 connectors, Length 105 cm Connector 28 mm female taper for mounting on inlet connector of the patient valve Connector 24 mm female taper for mounting on outlet connector of the bag Description Item number 1 Outlet cap (option) Expiratory connector Valve disc for patient valve (set of 10) Patient valve housing with pop-off valve Adult patient valve with pressure limiting valve complete Adult patient valve complete Adult Bag Inlet valve housing Inlet valve housing cover Inlet valve complete Valve disc small Flange nut Available in Reservoir bag Available in Override cap Adult patient valve housing Inlet valve housing and housing cover Flange nut and reservoir bag Manometer port cap Available in (Adult) 19 Extension tube with 2 connectors, Length 30 cm (Paediatric) Extension tube with 2 connectors, Length 90 cm Paediatric Bag Extension tube with 2 connectors, Length 105 cm Patient valve housing Connector 28 mm female taper for mounting on inlet connector of the patient valve Expiratory connector Connector 24 mm female taper for mounting on outlet connector of the bag Patient valve disc Paediatric Bag Paediatric patient valve with pressure limiting valve complete Patient valve housing Strap, complete with name plate Expiratory connector Patient valve disc Paediatric patient valve with pressure limiting valve complete

17 Technical Specifications Mark IV Description Item number 1 Outlet cap (option) Expiratory connector Valve disc for patient valve (set of 10) Patient valve housing with pop-off valve Adult patient valve with pressure limiting valve complete Adult patient valve complete A Ambu Mark IV inner bag B Ambu Mark IV outer cover C Ambu Mark IV connector, complete Valve disc small Flange nut Available in Override cap Adult patient valve housing Inlet valve housing Inlet valve housing cover Reservoir housing Reservoir cap Ambu Mark IV inlet valve complete Reservoir bag Reservoir bag complete Extension tube with 2 connectors, Length 30 cm Extension tube with 2 connectors, Length 90 cm Extension tube with 2 connectors, Length 105 cm Connector 28 mm female taper for mounting on inlet connector of the patient valve Connector 24 mm female taper for mounting on outlet connector of the bag A Ambu Mark IV Baby inner bag B Ambu Mark IV Baby outer cover C Ambu Mark IV Baby connector, complete Patient valve housing Expiratory connector Patient valve disc Paediatric patient valve with pressure limiting valve complete Strap, complete with name plate Laryngeal masks Ambu AuraOnce Infant Mask size Packaging color code Patient weight Maximum cuff inflation volume Adult #1½ #2 #2½ #3 #4 #5 #6 < 5 kg 5-10 kg kg kg kg kg kg >100 kg 4 ml 7 ml 10 ml 14 ml 20 ml 30 ml 40 ml 50 ml 9.6 mm 20 mm 10.6 mm 22.5 mm 11.3 mm 25 mm 44,2 g 62,3 g 76,6 g 21 ml 30 ml 38 ml Maximum intra-cuff pressure Airway connector Min. I.D. Tube Max. O.D. Tube Inflation valve Weight Internal volume of ventilatory pathway 60 cm H2O 5.2 mm 10.5 mm 7.3 mm 13 mm 8.6 mm 15 mm 9,8 g 13,5 g 19,4 g 5.5 ml 8 ml 11 ml 15 mm male (ISO ) 8.5 mm 8.5 mm 17.5 mm 17.5 mm Luer cone ISO ,1 g 30,8 g 15 ml 16 ml <0.8 cm <1.0 cm <0.8 cm <2.0 cm <1.2 cm <0.8 cm <0.5 cm <1.2 cm H2O H2O at 15 l/ H2O at 30 l/ H2O at 30 l/ H2O at 60 l/ H2O at 60 l/ H2O at 60 l/ H2O at 60 l/ at 15 l/min min min min min min min min Min. interdental gap 15 mm 17 mm 19 mm 21 mm 25 mm 29 mm 31 mm 32 mm Internal pathway 10.3 cm.0 cm 13.8 cm 15.9 cm 15.9 cm 17.8 cm 20.0 cm 22.0 cm Specialized use Max. FOB size 2.7 mm 2.7 mm 3.9 mm 3.9 mm 5.4 mm 5.4 mm 5.4 mm 5.4 mm Pressure drop 11 7A Product Phthalate-free Material Tube/Cuff Yes PVC Airway connector Yes PCTG Pilot balloon Inflation valve body Yes Yes PVC PVC Inflation valve plug Yes Polypropylene (PP) Inflation valve stem Yes Silicone The Ambu AuraOnce is not made with natural rubber latex Pediatric # Packaging Quantity Pouch 1 Box 10 Material Tyvek /Polyethelene Terephtalate (PET)/ Polyethylene (PE) Cardboard 7B 7C A C 24 B

18 Ambu AuraStraight Infant Pediatric Adult Mask size #1 #1 1/2 #2 #2½ #3 #4 #5 #6 Packaging colour code Patient weight <5 kg 5-10 kg kg kg kg kg kg >100 kg Maximum cuff inflation volume 4 ml 7 ml 10 ml 14 ml 20 ml 30 ml 40 ml 50 ml Maximum intra-cuff pressure 60 cm H 2 O Airway connector 15 mm ISO Min. I.D. Tube 5.7 mm 6.5 mm 7.4 mm 8.9 mm 9.8 mm 10.7 mm 11.0 mm.1 mm Max. O.D. Tube 9.6 mm 11 mm.2 mm 14.4 mm 16.1 mm 17.6 mm 19.3 mm 19.5 mm Inflation valve Luer cone ISO Appropriate storage temperature +10 C C Weight 9,8 g 13,6 g 17,8 g 27,0 g 38,2 g 44,9 g 62,9 g 69,6 g Internal volume of ventilatory pathway 3.5 ml 5.4 ml 6.7 ml 9.7 ml 13 ml 15 ml 20 ml 22 ml Pressure drop <1.5 cm H2O at 15 l/min <1.0 cm H2O at 15 l/min <1.9 cm H2O at 30 l/ min <1.0 cm H2O at 30 l/min <2.2 cm H2O at 60 l/ min <1.8 cm H2O at 60 l/ min <1.2 cm H2O at 60 l/min <1.2 cm H2O at 60 l/min Min. interdental gap.8 mm 15.1 mm 17.1 mm 20 mm 23 mm 25.4 mm 27.4 mm 28.7 mm Internal Pathway 10.9 cm 11.6 cm 14.4 cm 15.9 cm 16 mm 17.1 mm.8 mm 20.4 cm Specialized use Max. FOB size 2.7 mm 2.7 mm 3.9 mm 3.9 mm 5.4 mm 5.4 mm 5.4 mm 5.4 mm Ambu AuraFlex Pediatric Adult Mask size #2 #2½ #3 #4 #5 #6 Packaging Colourcode Patent weight kg kg kg kg kg >100 kg Maximum cuff inflation volume 10 ml 14 ml 20 ml 30 ml 40 ml 50 ml Maximum intra-cuff pressure 60 cm H 2 O 60 cm H 2 O 60 cm H 2 O 60 cm H 2 O 60 cm H 2 O 60 cm H 2 O Airway connector 15 mm male (ISO) 15 mm male (ISO) 15 mm male (ISO) 15 mm male (ISO) 15 mm male (ISO) 15 mm male (ISO) Min. I.D. Tube 6 mm 6 mm 7.5 mm 7.5 mm 8.5 mm 8.5 mm Max. O.D. Tube 9.7 mm 9.7 mm 11.5 mm 11.5 mm.5 mm.5 mm Inflation valve Luer cone ISO Luer cone ISO Luer cone ISO Luer cone ISO Luer cone ISO Luer cone ISO Weight 19.5 g 23.1 g 31.0 g 35.2 g 46.3 g 53.4 g Internal volume of ventilatory pathway 8.5 ml 8.5 ml 14 ml 14 ml 19 ml 19.5 ml Pressure drop <0.2 cm H 2 O at <0.2 cm H 2 O at <0.3 cm H 2 O at <0.3 cm H 2 O at <0.2 cm H 2 O at <0.2 cm H 2 O at 30 l/min 30 l/min 60 l/min 60 l/min 60 l/min 60 l/min Min. interdental gap 19 mm 22 mm 23 mm 27 mm 30 mm 33 mm Internal Pathway 22 cm 22 cm 24.5 mm 24.5 mm 26.5 mm 27 cm Specialized use Max. FOB size Product Phthalate-free Material Airway tube Yes PVC Cuff Yes PVC Airway connector Yes PCTG Pilot Balloon Yes PVC Inflation valve Yes PVC/Silicone Pilot tube Yes PVC The Ambu AuraStraight is not made with natural rubber latex Packaging Quantity Material Pouch 1 Tyvek /Polyethylene Terephthalate (PET)/ Polyethylene (PE) Box 10 Cardboard Product Phthalate-free Material Airway tube Yes PVC/Stainless Steel Cuff Yes PVC Pilot tube Yes PVC Inflation Valve Yes PVC/Silicone The Ambu AuraFlex is not made with natural rubber latex Packaging Quantity Pouch 1 Tyvek/PA/Polyethylene (PE) Box 10 Cardboard 34 35

19 Ambu Aura-i Infant Pediatric Adult Mask size #1 #1½ #2 #2½ #3 #4 #5 #6 Packaging color code Patient weight < 5 kg 5-10 kg kg kg kg kg kg >100 kg Maximum cuff inflation volume 4 ml 7 ml 10 ml 14 ml 20 ml 30 ml 40 ml 50 ml Maximum intra-cuff pressure 60 cm H 2 O Airway connector 15 mm ISO Min. I.D. Tube 6.3 mm 6.9 mm 8.7 mm 10.0 mm 11.0 mm.4 mm.7 mm.7 mm Inflation valve Luer cone ISO Appropriate storage temperatur +10 C C Weight 11 g 15 g 21 g 35 g 38 g 56 g 77 g 98 g Internal volume of ventilatory pathway 5 ml 6 ml 9 ml 14 ml 14 ml 24 ml 31 ml 36 ml Pressure drop <1.2 cm H 2 O at 15 l/min <0.8 cm H 2 O at 15 l/min <1.0 cm H 2 O at 30 l/min <0.8 cm H 2 O at 30 l/ min <2.0 cm H 2 O at 60 l/ min <1.2 cm H 2 O at 60 l/min <0.8 cm H 2 O at 60 l/ min <0.5 cm H 2 O at 60 l/min Min. interdental gap 15 mm 17 mm 20 mm 24 mm 26 mm 30 mm 33 mm 35 mm Internal pathway 9.1 cm 10.7 cm.2 cm 14.6 cm 14.2 cm 16.2 cm 17.8 cm 19.2 cm Intubation use Max. ET-tube The Ambu Aura-i is developed in conformity with the Council Directive 93/42/EEC concerning medical devices. Product Phthalate-free Material Airway tube Yes PVC Cuff Yes PVC Airway connector Yes PVC Pilot balloon Yes PVC Inflation valve Yes PVC/Silicone Pilot tube Yes PVC The Ambu Aura-i is not made with natural rubber latex Packaging Quantity Pouch 1 Tyvek /Polyethelene Terephtalate (PET)/Polyethylene (PE) Box 10 Cardboard Ambu AuraGain Pediatric Mask size #1 #1½ #2 #2½ #3 #4 #5 #6 Packaging color code Patient weight <5 kg 5-10 kg kg kg kg kg kg >100 kg Maximum cuff inflation volume 4 ml 7 ml 10 ml 14 ml 20 ml 30 ml 40 ml 50 ml Maximum intra-cuff pressure 60 cm H 2 O Airway connector 15 mm ISO Min. I.D. Tube 6.6 mm 7.2 mm 9.0 mm 10.2 mm 11.0 mm.7 mm.9 mm.9 mm Inflation valve Luer cone ISO Appropriate storage temperatur +10 C C Weight 14 g g 25 g 40 g 45 g 63 g 86 g 88 g Internal volume of ventilatory pathway 3.3 ml 4.4 ml 10.2 ml.3 ml 17 ml 25 ml 33 ml 33 ml Pressure drop 0.0 cm H2O at 15 l/min 0.0 cm H2O at 15 l/min 0.1 cm H2O at 30 l/min 0.1 cm H2O at 30 l/min <0.1 cm H2O at 60 l/min Adult <0.1 cm H2O at 60 l/min 0.1 cm H2O at 60 l/min <0.0 cm H2O at 60 l/min Min. interdental gap 11.6 mm 13.2 mm 16.2 mm.5 mm 21.0 mm 24.0 mm 25.9 mm 26.6 mm Internal pathway 9.4 cm 11.0 cm.7 cm 15.6 cm 14.2 cm 16.2 cm 19.0 cm 19.0 cm Intubation use Max. ET-tube Gastric channel use Max gastric tube 6 FR 8 FR 10 FR 10 FR 16 FR 16 FR 16 FR 16FR The Ambu AuraGain is developed in conformity with the Council Directive 93/42/EEC concerning medical devices. Product Phthalate-free Material Airway tube Yes PVC Cuff Yes PVC Airway connector Yes PCTG Pilot balloon Yes PVC Inflation valve Yes PVC/Silicone Pilot tube Yes PVC Gastric tube Yes PVC Packaging Quantity Pouch 1 Tyvek /Polyethelene Terephtalate (PET)/Polyethylene (PE) Box 10 Cardboard The Ambu AuraGain is not made with natural rubber latex

20 Ambu Aura40 Infant Pediatric Adult Mask size #1 #1½ #2 #2½ #3 #4 #5 #6 Colour/code pilot balloon Patient weight < 5 kg 5-10 kg kg kg kg kg kg >100 kg Maximum cuff inflation volume Maximum intra-cuff pressure 4 ml 7 ml 10 ml 14 ml 20 ml 30 ml 40 ml 50 ml 60 cm H 2 O Airway connector 15 mm male (ISO ) 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 Inflation valve Luer cone (ISO 594-1) Weight 13.5 g.3 g 24.6 g 33.9 g 38.3 g 53.2 g 73.0 g 90.5 g Internal volu-me of ventilatory pathway 5.5 ml 8 ml 11 ml 15 ml 16 ml 21 ml 30 ml 36 ml Pressure drop < 1.2 cm H 2 O at 15 l/min < 0.8 cm H 2 O at 15 l/min < 1.0 cm H 2 O at 30 l/min < 0.8 cm H 2 O at 30 l/min < 2.0 cm H 2 O at 60 l/min < 1.2 cm H 2 O at 60 l/min < 0.8 cm H 2 O at 60 l/min < 0.5 cm H 2 O at 60 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.0 cm 13.8 cm 15.9 cm 15.9 cm 17.8 cm 20.0 cm 22.0 cm Face Masks Ambu King face mask Size Weight 1 15g 2.4g g g g g 7RD 51.3g Part Material Cuff PVC Polyvinyl Chloride (Phthalate-free) Crown Polycarbonate Hook ring Polycarbonate Valve Body Polycarbonate Valve Stem Silicone Rubber Valve Plug PP Polypropylene Product Tube/cuff Airway connector Pilot balloon/manual vent Inflation valve adapter Inflation valve core Inflation valve body Inflation valve cap Inflation valve Inflation valve Packaging Pouch Box Environment PVC-free DEHP-free Ambu Cuff Pressure Gauge Specifications Dimension (lenght x width x height) Diameter of dial Weight Usage temperature Storage temperature Tubing connection Lenght of tubing Material Silicone Silicone Polyester Polyester Polypropylene (PP) Polypropylene (PP) Nitrile Stainless Steel Tyvek/PA/Polyethylene (PE) Terephthalate (PET)/Polyethylene (PE) Cardboard Yes Yes 150 x 75 x 75 mm 68 mm 166 g + 5 to +40 C + 5 to +40 C Luer type 100 cm Ambu Ultra Seal face mask Adult Size Weight without check value Weight with check value # 2-3 Toddler 37 g 38 g # 4 Small adult/child 44 g 45 g # 5 Medium adult 53 g 54 g # 6 Large adult 72 g 73 g Ambu UltraSeal face mask Pediatric Size Weight without check value Weight with check value # g 9.9 g # 1.4 g 13.2 g # g 20 g # g 26.1 g Product Material Mask dome Polyvinylchloride Cushion Polyvinylchloride Packaging Quantity Material Pouch 1 PP (Polypropylene) Box 20 Cardboard Product Inflation handle Dial Suspension hook Tubing Pressure adjustment button Material PVC Aluminium/Copper/Silicone Polyamide PVC Copper/Polyamide 38 39

21 Ambu Disposable face mask Size Neonate Infant Toddler Small adult/child Medium adult Large adult Ambu Silicone face mask Size Weight 0A Infant 28 g 0 Infant w.boring 39 g 0 Infant 38 g 2 Child 63 g 3/4 Adult/Child 78 g 4 Adult 80 g 5 Adult 105 g 6 Adult 105 g Ambu Open Cuff face mask Weight 9 g 14 g 25 g 33 g 47 g 49 g Product Phthalate-free Material Dome YES Polyvinylchloride Cuff YES Polyvinylchloride Check valve YES Polycarbonate Packaging Quantity Material Pouch 1 PP (Polypropylene) Box 20 Cardboard Product Cuff Cuff size 0A Dome Mask connector Size Weight 0 Infant 13 g 1 Infant 26 g 2 Child 41 g 3 Child 54 g 4 Adult/Child 76 g 5 Adult 102 g Material with foam filling Resuscitators Ambu SPUR ll without M-port disposable resuscitator Infant Paediatric Adult Stroke volume one hand 150 ml 450 ml 600 ml Stroke volume two hands 1000 ml Resuscitator volume 220 ml 635 ml 1475 ml Dimensions (length x diameter) 168 x 71 mm 234 x 99 mm 295 x 7 mm Weight, incl. reservoir and mask 140 g 215 g 314 g Pressure-limiting valve 4.0 kpa (40 cm H 2O) 4.0 kpa (40 cm H 2O) Dead space < 6 ml < 6 ml < 6 ml Inspiratory resistance Expiratory resistance Reservoir volume max kpa (1.0 cm H 2O) at 50 I/min 0.2 kpa (2.0 cm H 2O) at 50 I/min 300 ml (bag) 100 ml (tube) Parts Bag Patient valve housing Patient Connector Splash guard (only available with Adult and Pediatric versions) Expiratory connector Patient valve disc Luer connector Cap on M-Port Locking ring Valve in Pressure limiting valve Lock in Pressure limiting valve Override clip in Pressure limiting valve Spring in Pressure limiting valve Inlet valve housing Inlet valve housing cap Inlet valve disc Reservoir bag Reservoir tube Oxygen tube Manometer port cap / tube adaptor max kpa (5.0 cm H 2O) at 50 I/min 0.27 kpa (2.7 cm H 2O) at 50 I/min max kpa (5.0 cm H 2O) at 50 I/min 0.27 kpa (2.7 cm H 2O) at 50 I/min 2600 ml 2600 ml Raw materials SEBS SB PP SEBS PP LSR (Liquid Silicone Rubber) HIPS (High Impact Polystyrene) SEBS PC ABS ABS PC Stainless steel PC Adult and Pediatric: SB Infant: PC LSR (Liquid Silicone Rubber) LDPE (Low-density polyethylene plastics) EVA (Ethylene Vinyl Acetate copolymer) + PP (Polypropylene) PVC PE Product Mask Material 40 41

22 Ambu SPUR ll with M-Port disposable resuscitator Adult Pediatric Infant Stroke volume one hand 600 ml/ two hands 1000 ml 450 ml 150 ml Resuscitator volume 1475 ml 635 ml 220 ml Dimensions (length x diameter) 295 x 7 mm 234 x 99 mm 168 x 71 mm Weight incl. reservoir O 2 tube/ mask 314 g 215 g 140 g Pressure-limiting valve Pressure limiting valve*: 4.0 kpa (40 cm H 2 O) 4.0 kpa (40 cm H 2 O) 4.0 kpa (40 cm H 2 O) Dead space <6 ml <6 ml <6 ml Inspiratory resistance without Max kpa (5.0 cm H 2 O) O 2 at 50 l/min Expiratory resistance Max kpa (2.7 cm H 2 O) at 50 l/min Max kpa (5.0 cm H 2 O) at 50 l/min Max kpa (2.7 cm H 2 O) at 50 l/min Bag reservoir volume 2600 ml 2600 ml 300 ml Tube reservoir: Max kpa (1.0 cm H 2 O) at 5 l/min Max. 0.2 kpa (2.0 cm H 2 O) at 5 l/min Length: 245 mm (10 ) Diameter: 22 mm (7/8 ) Volume: 100 ml Patient connector: Outside 22 mm male (ANSI/ISO) 22 mm male (ANSI/ISO) 22 mm male (ANSI/ISO) Ambu Oval Silicone reusable resuscitator Description Adult Paediatric Neonate Stroke volumes 700 ml 450 ml 150 ml Patients weight > 30 kg (10 years) kg (1-10 years) < 10 kg (1 year) Total bag volume 1475 ml 635 ml 220 ml Dimensions (length x diameter) 291 mm x 8 mm (11.45 in. x 5 in.) 245 mm x 99 mm (9.65 in. x 3.9 in.) Oxygen reservoir volume 2600 ml 2600 ml 100 ml Patient connector Outside Patient connector Inside Expiratory connector (for PEEP valve attachment) Forward and backward leak Operating temperature Storage temperature 22 mm (ISO) 15 mm (ISO) 30 mm male (ISO) Not measurable - C to 50 C (-4 F to 2 F) at humidity between 15% and 95% -40 C to 60 C (-40 F to 140 F) at humidity between 40% and 95% 165 mm x 70 mm (6.49 in. x 2.7 in.) Patient connector: Inside 15 mm female (ANSI/ISO) 15 mm female (ANSI/ISO) 15 mm female (ANSI/ISO) Expiratory connector (for PEEP valve 30 mm male (ISO) 30 mm male (ISO) 30 mm male (ISO) attachment) Forward and backward leak Not measurable Not measurable Not measurable M-Port Standard Luer LS 6 Standard Luer LS 6 Standard Luer LS 6 Recommended operating temperature Storage - C to +50 C - C to +50 C - C to +50 C Tested at -40 C and + 60 C according to EN ISO Parts Bag Patient valve housing Patient Connector Splash guard (only available with Adult and Pediatric versions) Expiratory connector Patient valve disc Luer connector Cap on M-Port Locking ring Valve in Pressure limiting valve Lock in Pressure limiting valve Override clip in Pressure limiting valve Spring in Pressure limiting valve Inlet valve housing Inlet valve housing cap Inlet valve disc Reservoir bag Reservoir tube Oxygen tube Manometer port cap / tube adaptor Tested at -40 C and + 60 C according to EN ISO Raw materials SEBS SB PP SEBS PP LSR (Liquid Silicone Rubber) HIPS (High Impact Polystyrene) SEBS PC ABS ABS PC Stainless steel PC Adult and Pediatric: SB Infant: PC LSR (Liquid Silicone Rubber) LDPE (Low-density polyethylene plastics) EVA (Ethylene Vinyl Acetate copolymer) + PP (Polypropylene) PVC PE Tested at -40 C and + 60 C according to EN ISO This product does not contain natural rubber latex. The bags are made of silicone rubber Parts Bag Patient valve housing Patient Connector O-Ring (only patient valves with swivel) Expiratory connector Outlet cap (option) Valve discs Reservoir bag Flange nut Pressure limiting valve Override cap Bag support connector Inlet valve cover Inlet valve housing Cap for manometer port Inlet valve cover (Neonate) Inlet valve housing (Neonate) Reservoir tube Raw materials Polypropylene, reinforced Polyvinylchloride Polypropylene, reinforced /stainless steel Polyoxymethylene Polyoxymethylene Polypropylene/EPDM rubber Polyethylene 42 43

23 Ambu Oval Plus Silicone reusable resuscitator Description Adult Paediatric Neonate Stroke volumes 700 ml 450 ml 150 ml Patients weight > 30 kg (10 years) kg (1-10 years) < 10 kg (1 year) Total bag volume 1475 ml 635 ml 220 ml Dimensions (length x diameter) 291 mm x 8 mm (11.45 in. x 5 in.) 245 mm x 99 mm (9.65 in. x 3.9 in.) Oxygen reservoir volume 1500 ml 1500 ml 1500 ml Tube open reservoir Patient connector Outside Patient connector Inside Expiratory connector (for PEEP valve attachment) Forward and backward leak Operating temperature Storage temperature 22 mm (ISO) 15 mm (ISO) 30 mm male (ISO) Not measurable 165 mm x 70 mm (6.49 in. x 2.7 in.) 100 ml - C to 50 C (-4 F to 2 F) at humidity between 15% and 95% -40 C to 60 C (-40 F to 140 F) at humidity between 40% and 95% Ambu Oval Plus Silicone Resuscitators can be autoclaved repeatedly at 134 C This product does not contain natural rubber latex. The bags are made of silicone rubber Parts Bag Patient valve housing Patient Connector O-Ring (only patient valves with swivel) Expiratory connector Outlet cap (option) Valve discs Reservoir bag Flange nut Pressure limiting valve Override cap Bag support connector Inlet valve cover Inlet valve housing Cap for manometer port Inlet valve cover (Neonate) Inlet valve housing (Neonate) Window with snap faster Reservoir housing Adapter for reservoir bag Reservoir tube Raw materials Polypropylene, reinforced Polyethersulfone/Polyurethane Polypropylene, reinforced /stainless steel Polyoxymethylene Polyoxymethylene Polypropylene/EPDM rubber Polyoxymethylene/Polypropylene Polyethylene Mark IV reusable resuscitator Mark IV Mark IV Baby Application Pulmonary resuscitation of adults and children with a body weight of more than approx. 15 kg (3 years) Pulmonary resuscitation of neonates, infants and children with a body weight of up to 20 kg (approx. 4-5 years) Maximum volume delivered 1300 ml 300 ml Length x diameter (including 275 mm x 135 mm 265 mm x 85 mm patient valve) Weight of the resuscitator (with patient valve, without oxygen reservoir and mask) 415 g 190 g Maximum frequency of ventilation Depends on the tidal volume used. The rate of expansion of the bag is sufficiently fast for all frequencies recommended for practical use Patient connector 22/15 mm (ISO) Expiration connector (for PEEP valve attachment) 30 mm male (ISO) Dead space < 5 ml < 6 ml Leaks (both ways) Non-measurable Non-measurable Inspiratory resistance -at 50 l/min kpa (-3.5 cm H2O) -at 50 l/min kpa (-3.7 cm H2O) -at 5 l/min kpa (-0.5 cm H2O) Expiratory resistance - at 50 l/min 0.26 kpa (2.6 cm H2O) -at 50 l/min 0.45 kpa (4.5 cm H2O) -at 5 l/min 0.06 kpa (0.6 cm H2O) Maximum attainable delivery pressure With compliance of 0.2 l/kpa Approx. 10 kpa (100 cm H2O) With compliance of 0.01 l/kpa Approx kpa (115 cm H2O) Pressure-limiting system The elasticity of the outer cover of the bag limits Pressure-limiting valve opening pressure the airway pressure to approx. 7 kpa (70 cm H2O) approx. 4 kpa (40 cm H2O). If the pressurelimiting valve is overridden, the elasticity of when squeezing the bag normally with one hand the outer cover of the bag limits the airway pressure to approx. 4.5 kpa (45 cm H2O) when squeezing the bag normally with one hand Bag reservoir volume 1500 ml Application temperature - C to 50 C (0 F to 2 F) Storage temperature -40 C to 70 C (-40 F to 158 F) Inspiratory resistance of the oxygen reservoir bag (without supply of oxygen) - at 50 l/min -0.1 kpa (-1.0 cm H2O) - at 5 l/min kpa (-0.1 cm H2O) The Ambu Mark IV resuscitators comply with the following standards: ASTM F (99) and EN ISO :2002. The Ambu Mark IV resuscitators are in conformity with Directive 93/42/EEC concerning medical devices. Product Inner bag Outer cover Patient valve housing Patient connector Pressure-limiting valve* Override cap* Expiration connector Cap for manometer port* Inlet valve housing Screw cap (two parts) Reservoir tube* Valve discs Strap Nameplate Window with snap fastener Connector Oxygen reservoir bag*** Adapter for reservoir bag*/*** Reservoir housing incl. cap and screw cap*** Oxygen supply tube*** Adapter for tube**/*** Extension tube**/*** Splash guard**/*** Material PSU PSU/silicone rubber PSU/stainless steel Reinforced PP PP/EPDM rubber POM POM PE Aluminium PSU POM PES/TPU POM/Reinforced PP EPDM rubber POM EPDM rubber PSU * Mark IV Baby only ** Mark IV Adult only *** Optional accessory 44 45

24 Ambu Peep Valves Dimension Length Weight 65 mm, diameter 45 mm 40 g Product Transparent plastic parts Plastic parts of valve body Adjustment cap Sealing in adjustment cap Springs Material with delrin disc and silicone oil Polyamide (nylon) EPDM rubber Stainless steel** **) The spring in the Disposable PEEP Valve 20 is made of non magnetic stainless steel. Ambu Pressure Manometer Size Length Diameter Weight Connector size 55 mm (2.17 ) 22 mm (0.87 ) 6.4 g ID 3.7 mm (.15 ) Material Product Connector Spring Housing Piston Membrane Operating temperature range Storage temperature range SEBS CuSn SB PP Silicone -ºC a 50ºC -40ºC a 60ºC Measuring Measuring Limits Accuracy 0-60 cm H2O (hpa) +/- 2 cm H2O (hpa) a 7.5, 10, 15, 20, 30 H2O (hpa) +/- 3 cm H2O (hpa) a 40 H2O (hpa) +/- 5 cm H2O (hpa) a 60 H2O (hpa) Ambu ET Tube Holder Product Blue strap White strap Inducer (yellow) Tube body holder Packaging Pouch Box Material Silicone Nylon Polypropylen (PP) Polycarbonat Polyethylen (PE) Cardboard Breathing Bags King Breathing Bags 46 Part Bag Bushing Neoprene TPO (POE) Size 1/2L 1L Weight.4g 25.2g Tape Vinyl Tape (PVC with DEHP) 2L 37.6g 3L 56.5g Material 47