Patient Interface The Key to Better Patient Compliance

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1 C1 C2 The Key to Better Patient Compliance The demands made on the ventilation mask are enormous. In addition to a perfect fit, the mask has to withstand high therapy pressures, work quietly, allow the patient to exhale easily and be easy to use and kind to the skin. Our ventilation masks satisfy all these requirements, with some masks specialized for particular needs. The perfect mask is essential for good patient compliance. We offer the comfortable, the proven silicone and SilkGel variants of the family and the reliable. Thanks to the versatility of our products, every patient can find the mask that suits him best.

2 Our ma C3 sks... are q... fit pe... are c Concept... are e The Key to Better Patient Compliance... are s... let th... with The comfortable ones uiet r fectly o m fo r t able to a s y to u kin-frie e patie st and h we a r se ndly nt e x ha igh the le easil ra p y p r SilkGel Gel (gel) (gel) Full Face y e s su re s SilkGel Full Face Full Face Gel (gel) (gel) WEINMANN SilkTec Our coating WEINMANN SilkTec of liquid silicone rubber adds to With such a high degree of cleanliness, WEINMANN SilkTec fulfills wearing comfort. It is much smoother and therefore more hygienic than conventional coatings. the health care industry s basic requirements for medical products. The bestsellers Full Face Full Faceplus with chin support Nasal pillow mask * Weinmann s own sound level test: db(a) at 10 hpa measured in accordance with DIN EN ISO 3744 (from distance of one meter); only nasal pillow mask Solid and reliable Therapy devices SOMNOvent CR SOMNOplus Sleep therapy Our masks are compatible with all our SOMNO and VENTI products. Their compatibility is key to creating ideal treatment conditions and improving therapy compliance. VENTIlogic LS Ventilation therapy C4

3 C5 1 C6 Nasal and full face mask with Weinmann SilkTec Mask cushion 2 Forehead cushion 3 Forehead support adjustment 5 4 Headgear clips 5 WEINMANNstrap 6 Crossband : Full Face and Nasal Masks Tube anchoring strap Hook-and-loop tabs Mask frame Ball-and-socket joint Exhalation system 8 The mask s shape, fastening and setting elements were designed with ease of use in mind. Because it is so easy to put on and comfortable to wear, wins over patients, medical staff and dealers. Saves time and effort Medical staff benefit from the simplified mask fitting on the patient while patients appreciate the easy, intuitive operation that reduces the need for assistance from doctors and dealers. improves therapy compliance and effectiveness. With feedback from several tests we were able to optimize the fit and reduce to a minimum the risk of leakage and pressure points, especially around the nasal root. Enhanced with SilkTec is equipped with a special coating called WEINMANN SilkTec on the mask cushion and forehead cushion. It feels silkysoft against the skin and, in comparison to other silicone products, is much more comfortable to wear. Perfect fit Thanks to more precision Larger and softer around nasal root More accurate size adjustment Saves time Quick and easy to put on and take off Forehead cushion fitted on support Pre-set positions numbered for quick adjustment of forehead support Headgear clips with simple latch Easy to use WEINMANNstrap always holds mask in place New, optimized cut of elastic headgear WEINMANNstrap With adjustable cross-strap to prevent slippage Tube anchoring strap for optional fastening to reduce leverage on tube Color-coding of hook-and-loop and inside/outside of strap to avoid mix-ups Nearly indestructible Polyamide makes flexible yet extremely stable for better shape retention. More comfortable With pleasant touch of WEINMANN SilkTec Only the mask cushion and forehead cushion coated with Weinmann SilkTec come in contact with the skin. For increased wearing comfort. Weinmann SilkTec simplifies cleaning because nothing sticks to it. Freedom of movement And peace and quiet at night, thanks to exhalation system design The ball-and-socket joint lets patient turn in any direction. Exhalation system is very quiet HMV-Positionsnummern as air flow is directed through gap, away from patient and sleeping partner Single layer mask cushion is more hygienic

4 C7 C8 E 1 E2 E3 The Family Choose the best combination for your needs. Among your choices are the silicone and gel variants of the nasal and full face masks, which are presented on the next three pages. Members of the family:, GEL and SilkGel. F E 4 D 3 D 2 A Ball-and-socket set A1 Anti-asphyxia valve A2 Rotating sleeve E Forehead support E1 Gel forehead cushion E2 Silicone forehead cushion D 1 A3 Elbow A4 Retaining ring B Ball-and-socket set NV (NV = non-vented) C Mask body C1 Mask body E3 Fine adjustment E4 Coarse adjustment F Headgear, including clips C 2 C 1 C2 Pressure measurement connection D Mask cushion D1 Silicone mask cushion A 4 with chin support D2 Silicone mask cushion D3 Gel mask cushion F 1 A 3 You can use the masks of our family for sleep apnea and ventilation patients. The modular system lets you customize the mask for a perfect fit and the ball-and-socket joint adds to the patient s wearing comfort. The very quiet exhalation system on our masks is designed so that the air flow does not disturb the patient or his bed partner. Modular design of the family What s so special about our masks is their modular design. It guarantees a perfect fit by allowing nearly all components silicone or gel to be combined with each other. The interchangeable parts also help you to optimize your inventory management. All parts except the mask body may be ordered separately The mask body of our masks is available in sizes S to XL. The body is suitable for the soft silicone mask cushion, the firmer silicone mask cushion for higher pressures (for ventilation) and gel-filled cushion. You can also choose between silicone and gel for the forehead cushion. The elbow, which comes in a vented or nonvented variant, is easily attached to the body just like all the other components. Except for the mask body, all parts are available separately, so you can alternate the use of silicone and gel parts or use them interchangeably. Features of the nasal and full face masks in the family: Therapy comfort Ball-and-socket joint for freedom of movement and a secure mask fit The very quiet exhalation system lets the patient and his bed partner sleep soundly. Integrated pressure measurement connection allows quick and simple pressure measurement at the mask. Small and light: increases patient compliance. Non-allergenic, skin-friendly materials (latex-free) with surface structure that prevents sweating. Two silicone mask cushions to choose from: Low and medium therapy pressure up to 30 hpa High therapy pressure up to 40 hpa Optionally available with integrated exhalation system Operating convenience Easy to adjust Mask cushion attaches easily by pressing with palm of hand Many replacement parts available Vented elbow (including anti-asphyxia valve when indicated): transparent; non-vented elbow: blue Breathable headgear with practical clips Two-way adjustable forehead support, broad forehead cushion Easy to clean Safety The quick-release cord for fast removal of the mask is optionally available with all full face masks. B A 2 A 1

5 C9 C10 The Family of Masks Full Face Full Face plus Tube anchoring over the head GEL Nasal and full face masks with silicone cushion Weinmann s silicone mask The silicone variant of our is available as a nasal or full face mask. The advantages are described under The Family (Page C7). SilkGel Full face and nasal masks SilkGel SilkGel Nasal and full face mask with mask cushion and forehead cushion of gel Weinmann s SilkGel masks with WEINMANN SilkTec The SilkGel variants are available as nasal and full face masks. This generation of individually assembled masks is known for outstanding wearing comfort, thanks to the high-quality material WEINMANN SilkTec, which coats the mask and forehead cushions. Its extremely smooth surface feels soft and silky and guarantees comfort. The flexible cushion simplifies handling of our SilkGel masks. The gel parts, which are made leakproof by their inter-laced structure, can be cleaned quickly and easily. Features of the SilkGel masks: More wearing comfort, thanks to the smooth coating of WEINMANN SilkTec Easy to clean because hardly anything can adhere to the surface Simple-to-use headgear: The optimized cut and the colorcoded tabs make the headgear even easier to use. Tube anchoring strap on the headgear is an optional way to fasten device tube Extra storage or transport bag for patient Comfortable fit Some parts of polyamide, an extremely durable and stable yet flexible material GEL Nasal and full face mask with mask cushion and forehead cushion of gel Weinmann s Gel Masks The gel variant of the ventilation masks is available for both the nasal mask and the full face mask Full Face. Our custom assembly gel masks are known for their wearing comfort. The flexible cushion makes it easy to fit the mask to the patient. Everything about their handling is trouble-free. The gel parts are easy to clean and, thanks to the interlaced gel structure, are leakproof too. You can combine gel parts with all silicone parts from other members of the family and select different sizes (S, M and L) to find just the right fit of the right mask for every patient. Additional features of the GEL masks are: Sleeve of skin-friendly silicone filled with gel Mask cushion and forehead cushion of gel Especially hygienic single-layer mask body Extremely quiet (): Four standard models in four sizes (S, M, L and XL) packed, ready to use Full Face (): Three variants in four sizes (S, M, L and XL) for different areas of use: Full Face, vented (incl. exhalation system), with soft cushion, for pressures up to 30 hpa (OSA) Full Face 40 hpa, vented (incl. exhalation system), with firm cushion, up to 40 hpa Full Face NV 40 hpa, non-vented (without exhalation system with firm cushion, up to 40 hpa (Ventilation) Full Face plus ( with chin support): This variant of the family of masks offers you the advantages of the two-chamber principle: The first chamber covers the nose and mouth. Like the Full Face, this mask ensures minimum dead space. The second chamber, the lower part of the mask body, holds the chin as needed without generating an annoying flow of air on the chin. Small holes prevent sweating. In keeping with the modular system concept, all parts except the mask cushion are identical to Full Face. Tip: Full Face plus is particularly suitable for ventilation patients and for bearded patients. S M L XL

6 C11 C12 Nasal pillow mask SOMNOplus with integrated exhalation system and headgear, pre-assembled SOMNOplus Anchoring possibilities for device tube: over the head, to the left or right side, directed toward chest Quiet, quieter, quietest that s our new mask, the nasal pillow mask NP 15. As the name tells you, it is very quiet at only 15 db(a) *. That s like the sound of leaves rustling in the breeze. Thanks to the mask s two ball-and-socket joints and the tubeanchoring options, NP 15 guarantees unlimited freedom of movement without compromising on stability. The new mask sets the stage for restorative and healthy sleep. Top features of NP 15 the quietest nasal pillow mask has two ball-and-socket joints: one ball-and-socket joint on the mask body allows unlimited freedom of movement. the second ball-and-socket joint between mask and device hose ensures a stable, non-leak fit. two tube-anchoring options integrated pressure measurement connection no disruptive drafts ideal fit made of skin-friendly silicone different colors on the Velcro tabs (light blue on top, dark blue on the bottom) simplify handling of headgear pillows move separately adjustable cross-strap on headgear vertical adjustment of forehead support Competitive Comparison The ear never sleeps, so for sound and restorative sleep, we need peace and quiet. Our sleep can be disrupted by noises that measure about 20 db(a), which is as loud as a the ticking of a clock. The comparison of competitors masks with ours shows that all tested masks* are at least 3.3 db(a) louder than. Just 3 db(a) more is an sound level increase of 20%! Sound level db(a) db(a) difference Competitors * Weinmann s own sound level test: db(a) at 10 hpa measured as specified in DIN EN ISO 3744 (from a distance of one meter); only nasal pillow masks allows the patient to move around in his sleep as much as he wants to while the mask stays in place. The nasal mask has a ball-and-socket joint that picks up head movements and gently directs them to the hose. The hose can t lift the mask up or cause disruptive leaks. With the ready-to-use variant of, SOMNOplus, everything comes pre-assembled: the freedom of movement mask with integrated exhalation system and the headgear WEINMANNstrap (page C13) made of breathable material and equipped with EasyClip. The patient can quickly and easily secure the mask with the clips. The entire SOMNOplus set is designed to let the patient get out of bed without having to remove the mask. One simple movement separates the connection hose from the mask at a point between ball-and-socket joint and exhalation system. The difference is clear: with you order only the mask and have the option of assembling your own customized set with headgear and exhalation system. On the other hand, SOMNOplus is ready for immediate use. Compliance In medical terms compliance means the patient s willingness to follow the doctor s orders for long-term treatment. The word adherence is also used to describe the patient s actions either taking medicine or following a prescribed regimen or treatment even when the patient himself does not believe in the EasyClip Both nasal mask variants share the following features: Hardly any CO 2 rebreathing Reduced tension on hose for better air-tightness Also available in size XS () Simple operation Easy adjustment Reduced pressure on face Ball-and-socket joint guarantees freedom of movement. ISO cone: Adaptation to all conventional exhalation systems () Kind to skin; mask doesn t stick to skin effectiveness of the therapy or considers it unpleasant or fails to see immediate improvement. Masks are an essential part of successful treatment. If a mask doesn t fit, the degree of patient compliance declines and the overall success of treatment is threatened.

7 S L L Full Face C13 C14 Accessories Headgear WEINMANNstrap Silentflow 2 Noise suppressor Headgear WEINMANNstrap WM / WM Our headgear WEINMANNstrap offers you a perfect fit and simple handling. Thanks to the cross-strap, which fits every head shape and size, annoying slippage is a thing of the past. Leverage on the device tube can be eliminated by the optional tube anchoring strap. The color-coded parts simplify operation. The colors of the hook-and-loop tabs on the headgear call to mind a postcard from a summer vacation: sky blue on the top and dark blue like the ocean on the bottom. strap WM The proper fit of a mask depends on the mask s composition and the headgear. If the headgear is inflexible, the mask can press tightly on the face. If it is made of low-quality material that wears out, the mask can slip out of place. If it is difficult to put on, the patient could lose the motivation that is so crucial to successful therapy. You will never have such problems with strap. Our headgear is made of high-quality breathable materials that make it skin-friendly, elastic and robust for a long-lasting fit and easy care. strap and its four quick-close clips can be cleaned in the washing machine. strap Quick-release cord Headgear accessories Quick-release cord WM In an emergency the quick-release cord lets the patient or nurse quickly and easily detach the mask. In hospital, for example, when a patient has to vomit or at home when the patient wakes from a nightmare or becomes disoriented, it is easy to detach the mask from the patient. The quick-release cord is simply attached with a clip and hook-and-loop fastener. Exhalation systems Silentflow 2 WM Exhalation systems attached to the mask body often cause loud and annoying noise. In contrast, the clever design of our exhalation system Silentflow 2 ensures undisturbed sleep for the patient. The exhaled air quietly escapes through the gap and flows along the hose. The cover over the exhalation gap keeps the air from streaming directly toward the patient s body and prevents disruptive drafts. Silentflow 2 can be used in combination with all non-vented nasal masks. Noise suppressor WM In our noise suppressor the air silently bubbles through the micropores. Like Silentflow 2, it can be used in combination with all nasal NV masks. Endoscope adapter Endoscope accessory Endoscope Adapter WM Up until now an endoscopic examination of a ventilated patient required interrupting the ventilation, taking off the mask and putting it back on. Stressful moments for both patient and medical staff. While ventilation is stopped, the patient can face dangerous oxygen deficiency. The situation in turn puts the staff under pressure. With our new endoscope adapter, all of that is history. In order to conduct an endoscopic examination of your patient without trouble and without interrupting ventilation, simply replace the elbow on the mask with the endoscope adapter. Then guide the endoscope through the opening. M Product monograph Mask fitting templates S Mask Fitting Template Nasal Pillow Mask Mask cleaning instructions M Nasal How should I clean my accessories? 2 Brochure product monograph Interface between man and machine A Product Monograph with Usage Tips Fitting template NP 15 Nasal Cleaning instructions for patient use Our product monograph entitled tells you about the composition of our masks, the functions of their individual components and the role of masks in ventilation therapy. You can also find tips about their ideal use and handling.you can order the monograph free of charge from us or download a copy from weinmann.de, Science + Research, Medical Background Information. The right fit of a mask can greatly increase the patient s satisfaction. Therefore, careful fitting of the mask is extremely important. Our fitting template has proven to be very helpful in finding the right size quickly and easily for every patient. We offer two different fitting templates: one for the nasal and full face masks in the family,,, SOMNOplus and another for the nasal pillow mask NP 15. You can order the free fitting templates from our Customer Service (Tel. +49-(0) ) Fitting template family,, and SOMNOplus The cleaning process greatly affects patient s compliance with therapy and the service life of the individual mask components. The parts of our masks can be washed by hand in lukewarm water with a mild detergent or in a washing machine or dishwasher or sterilized by steam up to a temperature of 134 C. In our patient brochure How should I clean my accessories?, we give you recommendations on when and how you should clean the mask components. In addition to the cleaning schedules, our instructions for hospital use also list the procedures (i.e., chemical and thermal disinfection and sterilization) that Weinmann has validated and approved for use on individual components. Both brochures can be downloaded from weinmann.de, Homecare, Download, Brochure. Cleaning instructions for hospital use This notice concerns all mask types and mask parts which are to be disinfected/sterilized for use by a new patient in a hospital, sleep lab or ventilation unit. Please observe also the instructions for use for each mask type or part. The information is presented as follows: Table 1, Mask parts to be disinfected/sterilized; Table 2, Our recommended and validated disinfecting and sterilization procedures; and Table 3, List of active ingredients used and ingredient groups. Important instructions: If the institution responsible for processing (e.g., hospital) uses a different procedure or exceeds the disinfection or sterilization cycles, the institution assumes the responsibility for any effect on the masks. Discoloration of the forehead cushion and mask seal can occur. These changes do not impair the mask s function. Pay strict attention to the manufacturer s instructions when using cleansing, disinfecting or sterilizing agents. Please observe the instructions for use and safety data sheet for the handling of cleansing, disinfecting and sterilizing agents so as not to threaten the health of personnel. Our recommended and validated procedures for disinfection/sterilization We recommend the disinfectants Gigasept FF (new), Cidex OPA and Aniosyme DD1. An independent and accredited test laboratory has proven the compatibility and effectiveness for these disinfectants. Please observe the manufacturers instructions for these products. The procedure described is based on DIN EN ISO Sterilization of Medical Devices Information to be provided by the manufacturer for the processing of resterilizable medical devices. Important information about the choice of cleansing and disinfecting agents: The following should be considered when choosing a cleansing or disinfecting material: that it is suitable for the cleaning or disinfecting of synthetic materials, that a disinfectant with certified effectiveness (e.g., VAH/DGHM- or FDA approval or CE sign is used and that it is compatible with the cleansing agent used. The concentration and contact time provided by the manufacturer of the cleansing or disinfecting agent must be strictly observed. Note: Notice regarding disinfection/sterilization of Weinmann-masks in hospital use The Sterility Assurance Level (SAL) of the reusable mask components is 10-6 or one in a million when the mask components are disinfected or sterilized as described in the following procedures.

8 C15 C16 Overview The comfortable ones Bestsellers the complete collection Robust and reliable Full Face SilkGel / GEL SilkGel Full Face / Full Face GEL Full Face Nasal pillow mask SOMNOplus WM-Nummer Mask vented vented vented non-vented vented non-vented vented S M L XL / / / / / / / / / / / / hpa vented NV non-vented NV 40 hpa non-vented vented hpa vented NV 40 hpa non-vented Full Face plus vented vented non-vented vented Nasal Full face Silicone Gel Weinmann SilkTec coating SilkGel SilkGel SilkGel SilkGel vented non-vented Major use: sleep apnea therapy * * * * Major use: ventilation Pressure range 4-30 hpa 4-30 hpa 4-40 hpa 4-40 hpa 4-40 hpa 4-40 hpa 4-30 hpa 4-40 hpa 4-30 hpa 4-40 hpa 4-30 hpa 4-40 hpa 4-40 hpa 4-30 hpa 4-25 hpa 4-30 hpa 4-30 hpa Anti-asphyxia valve Ball-and-socket joint Sizes Adjustable forehead support Pressure measurement connection Quick-release cord (optional) External exhalation system can be added

Patient Interface. Central element in successful therapy. Patient Interface

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