E2-DigiMask - NASAL VERSION CUSTOMIZED NASAL INTERFACE AND ACCESSORIES

Transcription

1 E2-DigiMask - NASAL VERSION CUSTOMIZED NASAL INTERFACE AND ACCESSORIES TECHNICAL INFORMATION & DATA SHEET English version - ndgm part # USA REV 2HRI DEFINITIONS 1. E2-DigiMask Nasal is a respiratory medical interface whose shell is specifically made for one Patient for CPAP, Bi-Level mechanical ventilation. Patients involved with such a medical mask assembly are generally affected by Chronic Obstructive Respiratory insufficiencies. The methods of ventilation to be used are pressure related. Pressure can be delivered at one constant and continuous level (CPAP) or at two variable levels of pressure (Bi-level Pressure ventilation). Single pressure or Two pressure levels therapies can be delivered either continuously or intermittently with C02 venting features. E2-DigiMask Nasal should only be used upon medical prescription. 2. E2-DigiMask Nasal customized interface was designed for all patients being at least 30KG weight, whose human data to make the mask shell where acquired with Inventor s designed equipment and selected materials. Each customized nasal interface is called E2-DigiMask nasal. That custom shell is identified with a specific code allocated by the manufacturer which does not refer to Patients identity. Patient ID is unknown to the manufacturer of interfaces. 3. E2-DigiMask Nasal works along with a skin interface called E2-DigiSkin. E2-DigiSkin will attach to the mask headgear with two lateral locking systems (one to the right, the other to the left, called «Smart Clips». E2-DigiSkin is aimed to ensure an effective and comfortable seal with human skin while CPAP Therapy is delivered. E2-DigiSkin comes in three different sizes : Large Medium and Petite. The manufacturer will provide the correct E2-DigiSkin size to fit each custom mask shell, taking into account the mask shell perimeter. 4. E2-DigiMask Nasal will connect to the respiratory tubing using a specific ball joint system called E2- DigiPort.. E2-DigiPort is with CO2 vent holes and Deflector. 5. E2-DigiMask Nasal works with specific headgears called E2-DigiStrap. E2-DigiStrap offers three different models : o Simple Version with 3 sizes Large, Medium and Petite o Total Version with 3 sizes Large, Medium and Petite o Total PolyNET version with 3 sizes Large, Medium and Petite 6. For all questions about the method of acquisition and how the mask shells and accessories are made, please contact your local distributor, manufacturing licensed centers or the original manufacturer : E2MA s.a. 42, rue des Erables Mercières aux Bois La Croix Saint Ouen France Tel : Fax: e2ma@e2ma-sa.com Web: 7. E2-DigiMask, E2-DigiPort, E2-DigiStrap are trade marks belonging to E2MA s.a. 8. E2-ImaGik et E2-DigiSoft software systems developed to ensure proper 3D human acquisition numeric information and to allow the numeric design of each nasal shell according to defined R&D parameters. These software systems can be used only after the effective payment of license fees. E2MA s.a. owns E2- ImaGik et E2-DigiSoft copyrights. MAKERS OF RESPIRATORY VALVES SINCE 1938 HANS RUDOLPH, inc Wyandotte Kansas City, MO USA Phone: USA & Canada Fax: hri@rudolphkc.com Website: Hans Rudolph, inc., an ISO 9001, ISO EN Certified Company, and our products carry the CE-Mark.

2 9. E2-ImaGik Projector provides colored straps on the target. The projector is attached to a standard digital camera. 10. Part numbers and product components list : E2-DigiPort TM Ball joint connector Part E2-DigiPort assembly with CO2 vent mm OD connecting ring mm ID connecting ring Cap plugs (02) for sampling ports E2-DigiSkin TM Skin interface envelope for mask shell Part Large size E2-DigiSkin Medium size E2-DigiSkin Petite size E2-DigiSkin E2-DigiStrap TM HEADGEAR Part E2-DigiStrap Total Large NO Smart clips E2-DigiStrap Total Medium NO Smart clips E2-DigiStrap Total Petite NO Smart clips E2-DigiStrap Simple Large NO Smart clips E2-DigiStrap Simple Medium NO Smart clips E2-DigiStrap Simple Petite NO Smart clips E2-DigiStrap Total PolyNET Large NO Smart clips E2-DigiStrap Total PolyNET Medium NO Smart clips E2-DigiStrap Total PolyNET Petite NO Smart clips Smart clips assemblies: 1 pack E2-DigiMask TM Nasal Customized interface Part Nasal custom shell E2-ImaGik - 3D acquisition software & hardware Part License number E2MA s.a E2-ImaGik Projector E2-ImaGik Projector and Digital camera assembly Manufacturer warranty : Each of the above-listed components benefit from a 6 months manufacturer warranty, date of shipment. Should the product assembly be found defective due to improper product use or because product instructions are not followed up are enough conditions to cancel the manufacturer warranty. Shelf life for each product component with the exception of the mask shell is limited to 5 years, date of shipment. Any product defect should be reported to the Manufacturer via his authorized representative by following the procedure in place and described at the end of this manual. Any product being returned to the manufacturer outside the limits set by the procedure will automatically be rejected. 13. Only those entities with an authorized client number can place an order for E2-DigiMask Nasal interface and accessories. 2

3 CAUTION 1. E2-DigiMask Nasal mask assembly and or components are all LATEX free products. 2. All E2-DigiMask Nasal used materials have been carefully selected by the manufacturer to be biocompatible with all skin contact points. Should patient skin irritations be appearing after the use of E2- DigiMask Nasal mask, please contact your physician.. 3. E2-DigiMask Nasal mask is made for medical applications and will require a medical prescription from specialized physicians. Evidence for such a medical prescription might be required by the manufacturer or his authorized representative prior of one purchase order validation and acceptance. 4. E2-DigiMask Nasal mask has been specifically designed to meet requirements set for interfaces used in Positive Pressure Ventilation therapies, whether there is one continuous or various continuous or intermittent pressures values set. Pressure values are set by authorized medical specialists. Those pressure values should be strictly respected when E2-DigiMask Nasal mask is used. 5. E2-DigiMask Nasal mask should never be used sealed on the face as long as the air generator is not switched on. Prior to install E2-DigiMask Nasal mask, please ensure that the air generator is switched on and works properly. a. Prior to install E2-DigiMask Nasal mask, please ensure that the E2-DigiPort, please check that the E2-DigiPort air is properly vented via the Deflector. Never obstruct the Deflector area. b. The non-observation of the above-mentioned procedure may create a risk of asphyxia. 6. E2-DigiPort comes with sampling port plugs. Please, make sure that the ports when not used are always plugged with their appropriate caps. 7. Be aware that bags used to pack E2-DigiMask Nasal can be once opened a source of asphyxia if left in non-responsible hands. It is important, once the product assembly is unpacked, that you get rid of the bags according to disposal rules that apply to your country. 3

4 EXPLODED VIEW E2-DigiMask nasal 4

5 E2-DigiStrap TOTAL E2-DigiStrap SIMPLE Smart Clip mâle 1 Part L Part M Part P Part L Part M Part P Pressure-Flow curve : E2-DigiMask Nasal VENTED L/Min pressure L/Min Cm H2O Caution - E2-DigiMask nasal Mask is shipped completely assembled. Accessories to complete the custom mask shell comply with the medical prescription, the air generator used and the purchasing order placed with the manufacturer. The manufacturer and his authorized representative cannot be responsible and liable if upon the first product delivery, the mask assembly is not complete or does not fully comply with the medical prescription or the air generator used due to improper purchasing procedures. Should the product assembly received be found quality defective, please fill out the quality form attached to this manual and return it to your distributor or your product manufacturer. - E2-DigiMask Medical Dealer is skillful about NIV equipment. - The proper complete adjustment of E2-DigiMask nasal mask is the medical dealer s responsibility. The Medical Dealer is responsible for providing adequate training to mask users. - Never return the mask assembly or one component without having a Return Authorization Number (RAN) - It is important to always keep the serial number of mask shells in a safe place so that the manufacturer can easily duplicate the shell in a reduced period of time. 5

6 INTRODUCTION Intended use, Indications and contraindications E2-DigiMask nasal is a customized respiratory interface to deliver non invasively, intermittently or continuously one or two levels of pressure. The mask shell is designed for one given patient. Such a mask shell is always identified with one specific serial number. Unpack your E2-DigiMask nasal mask and check on all components integrity. - store the shell interface serial number for easy retrieval. - Trash bags and boxes. After reading, store this manual for easy retrieval. Intended Use: The Hans Rudolph Series One Reusable Adult E2-DigiMask TM Nasal CPAP/NIPPV Mask is a custom-fit, reusable, single patient multi-use, adult nasal CPAP and noninvasive positive pressure ventilation mask which incorporates passive exhaust vents at the patient connection. It is intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilation devices that require this passive exhaust vent configuration. Indications for Use & Environment: The Masks are specifically indicated for use on adult patients for treatment of obstructive sleep apnea or any other conditions requiring CPAP or non-invasive ventilatory support in homes, hospitals, and other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect. Contraindications: The masks will not remain sterile between repeated single-patient uses and should not be placed over open wounds that are prone to infection. Cleaning, disinfection, and sterilization procedures are included as part of the Instructions for Use. The Masks may not be suitable for use on patients with the following conditions: 1. open wounds that are prone to infection 2. hemodynamic or cardiorespiratory instability 3. unconsciousness 4. claustrophobia, anxiety, or other discomfort with nasal mask 5. facial or nasopharyngeal deformity, beard, or other inability to fit mask & seal properly 6. excessive nasal secretions 7. upper airway obstruction or facial trauma 8. barotrauma 9. recent facial surgery 10. patients unable to remove mask 11. patients requiring immediate intubation Complications: The Masks are non-invasive devices. The silicone surface which is applied directly to the patient s skin is soft, pliable and a biocompatible material. The masks are safe in both construction and use. This has been confirmed by the performance of Verification and Validation Testing, 6

7 Following are some possible minor to moderate complications: 1. infection due to improper use over open wounds 2. skin irritation after prolonged use caused by rubbing of the mask 3. nasal or dental pain or deformity 4. drying of pharyngeal and nasal mucosa 5. eye irritation or conjunctivitis 6. gastric distention and abdominal pain or flatulence from ingested air 7. some slight discomfort after prolonged use 8. decreased secretion clearance especially during upper respiratory tract infections General Device Description: The Hans Rudolph Series One Reusable Adult E2-DigiMask TM Nasal CPAP/NIPPV Masks system consist of the following components: 1. E2-ImaGik proprietary projector (at user site) 2. User s digital camera meeting certain minimum requirements 3. E2-ImaGik and E2-DigiSoft proprietary software (at production site) 4. Nasal E2-DigiMask customized mask cone 5. E2-DigiSkin sleeve 6. E2-DigiPort articulated knee-joint 7. E2-DigiStrap adjustable head gear The Nasal E2-DigiMask cone is customized to fit a particular patient s face. All that is required is a single picture of the patient s face taken with the user s digital camera (meeting certain minimum requirements) in combination with the proprietary E2-ImaGik projector. This results in a conventional JPG picture file which is subsequently sent to the mask production site. The user also has to take a special picture for calibration purposes the first time he or she uses that E2-ImaGik projector and digital camera combination. This calibration picture as well as the camera information is sent to the production site and is stored within the E2-ImaGik software. It is used to authenticate each patient JPG picture received. Once the JPG picture is received at the production site via (or some other transport means), the manufacturing process begins. The JPG picture is transformed into a three-dimensional file of the patient s face by the proprietary E2-ImaGik software. The proprietary E2-DigiSoft software then takes over. It allows HRI to determine the dimensions of the customized mask cone for production. The E2-DigiSkin is a single-piece elastic silicone rubber sleeve which fits over the E2-DigiMask TM customized mask cone. It includes a nasal mask cone envelope and two headgear extensions with lateral strap connectors. Three E2-DigiSkin TM sizes are available to accommodate various sizes of customized Nasal E2- DigiMask TM cones: small, medium and large. These are shipped to the user already assembled to the E2- DigiMask TM cone. The E2-DigiPort articulated knee-joint consists of a 21.5 to 22.5 mm conical connector for the respiratory circuit, two standard connectors for accessories, and a 15 mm ID male clip to E2-DigiMask TM piece. The E2- DigiPort TM is the component that has the built-in passive mask vents. There are three sizes of the E2-DigiStrap adjustable around-the-neck headgear and three sizes of E2- DigiStrap over-the-head adjustable headgear. All have easily accessible window space at both left and right E2-DigiSkin headgear connecting levels to quickly allow safe and easy opening and closing of headgear clips. Headgear foam material promotes patient comfort. All components are easily cleanable in accordance with the Instructions for Use. Device Materials: The E2-DigiSkin sleeve, which comes into contact with the patient s skin, is constructed of latex-free silicone rubber. This material has successfully undergone biocompatibility testing at a nationally recognized biological testing laboratory. The E2-DigiPort TM which can come into contact with the humidified air stream is composed of biocompatible polycarbonate plastic material. The E2-DigiMask TM cone is constructed of 7

8 PETG plastic material. The E2-DigiStrap TM materials consist of polyester sponge, polyamide and Velcro TM materials with polycarbonate clips. These materials are routinely worn in clothing in direct contact with human skin and are fully biocompatible. QUALITY and MATERIALS Components materials and recyclability Product/component Materials Percentage Recyclability Method Customized E2-DigiMask Nasal shell Polyethylene Terephthalate Glycol (PETG) 100% Incineration E2-DigiPort and Smart Clips Polycarbonate 100% Incineration E2-DigiSkin Medical Silicone 100% Incineration E2-DigiStrap Polyester Polyamide 75% 25% Incineration EQUIPMENT IS SHIPPED CLEAN BUT NOT STERILE - E2-DigiMask nasal mask assemblies or accessories are packed after being washed at the factory site. All E2-DigiMask nasal mask products are delivered clean, non-sterile.. - Should product packaging be damaged over transportation, it is recommended that all mask components be washed prior to be used. CAUTION Transport liability and storage - The manufacturer cannot be liable for damages created to the packaging and products over transportation. - E2-DigiMask nasal mask and components should be stored in a clean and dry environment with low humidity at temperatures not being above or below: +35 C / -5 C. Silicone parts should not be directly exposed to sunlight as the sunlight will cause silicone to yellow with no affect on the product performance. 8

9 English version ndgm part # USA REV2 AUG 05 E2-DigiMask Nasal Mask CLEANING AND WASHING INSTRUCTIONS The manufacturer recommends to daily wash E2-DigiMask nasal mask assembly after usage. - Washing by hands: separate the headgear from the mask using Smart Clips o E2-DigiMask nasal without headgear: submerge the product assembly into warm water with mild neutral ph detergent. Soak the mask assembly during 5 minutes. Scrub the mask with a soft brush. Please, note that all mask components should be disassembled once every two weeks and be thoroughly cleaned, piece by piece as above-mentioned. Rinse the device with warm tap water at least 3 different times for one minute. Dry the inside and outside of the mask with a clean, lint free cloth. o E2-DigiStrap Headgear : please, check all symbols on the headgear label first. Submerge the headgear into warm water below 30 C with a mild neutral ph detergent. Soak the mask assembly for 5 minutes. Repeat that operation 3 times. Dry the headgear with outside air or in the drying machine. Should you be using a drying machine, never set the drying temperature above 30 C and for no longer than 5 minutes. Prior to insert the headgear into the drying machine, make sure that Velcro pads are attached to the headgear so that they don t attach on other clothes. - Dishwasher : the complete E2-DigiMask nasal mask assembly with E2-DigiStrap headgear attached are dishwasher safe use short economical cycles only with 40 maximum. Use a low ph detergent such as those made for glasses. When taking your E2-DigiMask nasal mask assembly out of your dishwasher, leave it for a few minutes in fresh air for a complete drying process and to eliminate residual humidity. Once every two weeks, completely disassemble your E2-DigiMask nasal mask components and proceed the same way for dishwasher cleaning. CAUTION Chlorine, alcohol, bleach and heavy ph detergents solutions are prohibited for washing your mask or headgear. CAUTION equipment integrity after cleaning and washing Check each of the components: visual and functional replace defective components prior to product use. 9

10 INSTRUCTIONS of USE E2-DigiStrap Headgear (Simple and Total models) Manual Part # USA REV2 AUG Proper size selection: Simple or Total models Neck perimeter in cm Size code Up to 36 cm Petite P 37 cm to 42 cm Medium M Above de 42 cm Large L Please, check from shirt neck size or use a meter to select the size that you need. 2. Model selection: Simple or Total Please, check from the table below to select the proper headgear type that you need : Patient circuit type Patient stress level E2-DigiStrap model Light, single limb with no added Low Simple valves. Reactive and autonomous patient Light, single limb with no added Medium Simple valves. Reactive and 80 % autonomous patient Light, single limb with no added High Total valves. Reactive but unconsciousness risks and threats Single limb with added valves and N/A Total Y piece Heavy ICU patient circuit with Y piece N/A Total Upon shipment from the production center, E2-DigiMask Nasal arrives completely assembled

11 Installing and adjusting the headgear and the mask assembly E2-DigiMask Nasal is shipped completely assembled. ACTION SIMPLE TOTAL POLYNET Unpack the mask assembly and check product integrity Unlatch one of the lateral Velcro pads Connect the tubing to E2-DigiPort and switch the blower on Install the mask assembly on the face. Patient should have his chin on the chest. Pull on the two lateral Velcro pads un until leaks are eliminated. Patient can stand comfortably. Adjust the upper Velcro strap of the total headgear model around the head Note : there is no need to strongly tight the headgear on the face to eliminate leaks. 11

12 ACTION SIMPLE TOTAL POLYNET Adjust the third attachment pad according to needs and if the third attachment point is required To release the headgear, use one of the Smart Clips. NOTE : There is no need to make the headgear too tight on the face : E2-DigiSkin with the two elastic silicone tensors will smoothly follow your head movements, keeping the mask stable, leak-free and comfortable on the face. CAUTION regularly check on your headgear product integrity After each ventilation procedure, after each washing procedure, check on your headgear adjustments and proceed with necessary adjustments if required. HEADGEAR RELEASE and REINSTALLATION In routine situations, just unlock the two Smart clips (left or right) to release the mask. The headgear will maintain your set adjustments. To readjust the headgear, follow the above instructions. CAUTION Releasing the mask in urgent or in panic situations. Under urgent or panic situation, it is always possible to release the headgear : - By pulling on one (or both ) of the lateral Velcro pads. - By pulling the headgear and mask assembly above the head. 12

13 INSTRUCTIONS of USE Ball Joint connector E2-DigiPort and ring connectors to tubing Manual part # USA REV4 AUG 05 English E2-DigiPort is a ball-joint type of connector that connects to the mask shell and to the respiratory tubing. E2- DigiPort significantly contributes to the quality and efficacy of CPAP and Bi-level pressure therapy. CAUTION Vented E2-DigiPort E2-DigiPort is with CO2 venting features. The technical features applying to E2-DigiPort are shown in the technical E2-DigiMask data sheet. E2-DigiPort CO2 venting feature is designed according to the norms applying to CPAP ventilation. E2-DigiPort vent feature is a calibrated device. Blocking the venting, adding or accumulating other vented devices to the patient circuit or using air generators working with software systems that do not take into consideration E2-DigiPort current validated venting parameters may create technical issues when CPAP therapy is delivered.: - Don t Block E2-DigiPort venting holes and the Deflector. - Don t cumulate with E2-DigiPort any additional vented valve with the patient circuit. - Don t use air generators that do not comply with validated norms in CPAP Therapy 1. Selecting connector ring Selecting connector ring 15mm ID 15mm OD 22mm ID 22mm OD Tubing End Size 15mm OD 15mm ID 22mm OD 22mm ID Connector Ring Select the connector ring according to the diameter of tubing used : 22mm Internal diameter or 15mm internal diameter - 22mm Outside diameter or 15mm Outside diameter. 2. Assembling E2-DigiPort I - Vented half-sphere to the custom mask shell ii- Half sphere to the connecting ring 13

14 iii Complete vented E2-DigiPort assembly E2-DigiPort is composed of : i. One first half-sphere (with CO2 vent holes and deflector) that snaps in or unsnaps from the nasal customized interface E2-DigiMask nasal. That first half-sphere offers 360 of rotation around the mask piece. ii. One second half-sphere that snaps into the first. The two half-spheres together provide another 360 of rotation and also allow 120 flexible movements upwards and downwards. That second half-sphere ends with a snap-in ring connector. That part of E2- DigiPort provides two sampling ports iii. The ring connector (4 different diameters) provides another 360 of rotation. Once the ring is assembled to the connector, it cannot be unclipped. NOTE : E2-DigiPort offers 1200 of rotations which not only allows the respiratory tubing to be positioned at required position but also to reduce its pulling effects. E2-DigiPort assembly: A B C a- The first half-sphere snaps in the respiratory interface shell. b- The second half-sphere snaps in the first one and in the connecting ring. Sealing of the two spheres operates when air is delivered by the generator c- The ring connector adapts to the respiratory tubing. d- Check all connections. 14

15 INSTRUCTIONS of USE E2-DigiSkin Skin Interface and Smart Clips Manual part # USA REV2 AUG 05 English E2-DigiSkin is a medical silicone rubber type of envelope designed to envelop the custom mask shell. E2-DigiSkin is used at the same time as one skin interface (E2-DigiSkin, E2-DigiMask nasal shell envelope is also one smooth and comfortable cushion applying to the face. E2-DigiSkin is made in different sizes : Petite Medium and Large. The choice of the correct size is made by the mask shell manufacturer and is based on each mask shell perimeter. Smart clips female connectors will connect to each E2-DigiSkin lateral tensors. 1- Assembly : E2-DigiKin on E2-DigiMask nasal customized shell Large Medium Petite a- Make a note of the upper and lower portions of E2-DigiSkin. Turn the large opened of the DigiSkin inside out as you would do for putting a shock on your foot. b- Position the upper part of the mask shell with the upper part of E2-DigiSkin and center the two product holes in alignment with each other. c- Ensure that the shell is matted with the inner groove of E2-DigiSkin and adjust the whole assembly d- Snap fit E2-DigiPort. The ball-joint connector should be free of rotations from the mask shell and insert Smart Clips female part on each of E2-DigiSkin. CAUTION Upper and lower E2-DigiSkin, E2-DigiSkin and Smart Clips Installing E2-DigiSkin or mask shell or Smart Clips up-side-down will not allow the proper use and performances of your E2-DigiMask nasal customized product assembly. Read the manual and try again. Some practical information for best performances - Wash your face with soapy water prior to each ventilation procedure - Ensure that the mask is properly adjusted. - There is no need to over-tighten the headgear - Don t hesitate to contact your DME or physician to better understand all benefits from E2-DigiMask nasal mask assembly. - Don t hesitate to replace your E2-DigiMask nasal mask components when they have been used excessively for long period of time or if your body weight has fluctuated to a large degree. End of Technical information and Data sheet See appendixes 15

16 APPENDIX 1- RETURNING DEFECTIVE EQUIPMENT or ACCESSORIES E2-DigiMask nasal mask and accessories are made according to the most effective quality procedures and controls. The manufacturer follows ISO 9001:2000 and ISO 13485:2003 quality management procedures and SD Sustainable Development guidelines. It may however happen that the product or any accessory will be found defective when being unpacked and used. These products will benefit from the manufacturer warranty as long as all instructions of the manual were properly applied to the product and its accessories. Upon a product quality report, the manufacturer will implement corrective actions so that the issue is not met again. A permanent quality improvement process is one of the manufacturer s commitments. CAUTION Equipment can only be returned with a Return Authorization Number (RAN). Protecting the complete E2-DigiMask nasal mask human chain from product research to product use is the manufacturer s permanent concern. For that reason, any claimed defective product being returned to the manufacturer without a Return Authorization Number (RAN) will be immediately destroyed upon receipt (product and packaging) and the sender will not be able to claim damages since this instruction makes him aware of the procedure. RETURN EQUIPMENT PROCEDURE a- Inform your medical dealer about any equipment being defective.. b- Provide a written report to describe the quality issue: specify the serial number of your E2-DigiMask nasal shell. c- If at all possible, provide evidence of the issue, with a photo as instance. d- Sent your report and documentation to your medical dealer or authorized distributor. e- Await further instructions from your medical dealer or authorized distributor : i. Should the defective product evidence report be enough, you will be provided with a replacement part or product assembly free of charge, under warranty terms. ii. OR, you (or your DME/Authorized distributor) will be provided with one Return Authorization Number and address where to return the defective product. That procedure is for manufacturer s for further investigation and quality improvement. IN THAT CASE ONLY WITH A RAN : Thoroughly wash the product per instructions contained in the manual. Make a clear written statement onto the package with: the serial number of the E2-DigiMask nasal interface to which the product apply, add «Product washed and clean» and clearly mention your RAN. Your DME &/or distributor will be getting the final conclusions about the product incident. Any received package that does not clearly show above-mentioned written indications will be immediately destroyed upon receipt and the sender will not be able to claim damages since this instruction makes him aware of the procedure. 16

17 APPENDIX 2- QUALITY QUESTIONNAIRE Please, spend some of your time to complete the below questionnaire aimed to help us better serve all E2- DigiMask nasal users. Please, return the questionnaire via or post directly to your authorized distributor or to the original manufacturer. Who are you? Patient Your E2-DigiMask nasal interface serial number(s) DME Physician Distributor Other Are your observations about? E2-DigiMask nasal interface User manuals E2-DigiPort E2-ImaGik Software E2-DigiSkin E2-Imagik Hardware Simple E2-DigiStrap E2-DigiSoft Software Total E2-DigiStrap Others Are your remarks about? DME Delivery times Installation conditions Physician Transport Distributor Date of equipment delivery Date of questionnaire MM/DD /YY MM/DD /YY Your comments, observations and remarks : Original manufacturer address : E2MA s.a. 42, rue des érables Mercières aux Bois LA CROIX SAINT OUEN France Central e2ma@e2ma-sa.com. Web : 17