Exhibit 71 - Docket Alarm
Contents
1. if you frequently experience nasal irritation and consult your physician e If oxygen is used with the flow generator the oxygen flow must be turned off when the flow generator is not operating Explanation of the Warning When the flow generator is not in operation and the oxygen flow is left on oxygen delivered into the ventilator tubing may accumulate within the flow generator enclosure Oxygen accumulated in the flow generator enclosure will create a risk of fire This warning applies to most types of flow generators e Please refrain from smoking while oxygen is in use Note At a fixed flow rate of supplemental oxygen flow the inhaled oxygen concentration will vary depending on the pressure settings patient breathing pattern interface selection and the leak rate Willow Nasal Pillows System User Manual V4 Parts of the Willow Headgear Assembly gt Tube Retainer gt Tube Retainer CV Back Strap Pillow Sleeve Panels Swivel 5A x Figure 1 Construction of the Willow Willow Nasal Pillows System User Manual V4 Nasal Pillows Sizes You can choose the appropriate nasal pillows from S M and L sizes depending on individual dimensions Figure 2 The dimensions of the nasal pillows Fitting the Willow Insert the rectangular block Rotate the panel to a proper Thread the top and back at the smaller end of the position Fix the other panel straps through t2. 5 Willow Nasal Pillows System User Manual V4 Daily Mi Handwash the pillow sleeve assembly short tube assembly and cap in warm approx 30 C soapy water for one minute Use pure soap Rinse the components well with drinking quality water and allow to air dry out of direct sunlight and heat Note Insure that the vent holes are not blocked Use a soft bristle brush to clean the vent Weekly aaa Gently handwash the headgear and all components in warm approx 30 C and soapy water Use only pure soap and water Rinse the components well and allow them to air dry out of direct sunlight CAUTION e Donotuse solutions containing bleach chlorine alcohol aromatics moisturizers antibacterial agents or scented oils to clean any part of the system or air tubing These solutions may cause damage and reduce the life of the product e Exposing any part of the system or tubing to direct sunlight or heat may cause deterioration e If any visible deterioration of a component is apparent cracking crazing tears etc the component should be discarded and replaced Reassembling the Willow t Ar NN r NG P 4 T an F Wrap the pillow sleeve Insert the pillow sleeve edges Hold the clip and align the around the frame in the into the groove of the frame circle in its middle with the correct position Make Make sure assemble itinthe one on the frame Gently sure the nasal pillows are right side or it can n
3. Exhibit 71 35 Willow Nasal Pillows System User Manual Table of Contents Willow Nasal Pillows System o oo oooooooo Intended Use me rice bs ae es a a ee Bee ee Medical Information 0 Parole WOW e 22 30 0 baog 0 Nasal Pillows SIZ6S lt 22 22 2 21 ba ea Fitting the Willow es cional ara Er aaa a ra dite ws Using Tube Retainer Optional Removing the Willow aa 22 4 2 See at od bees Disassembling for Cleaning cece eee ees Cleaning the Willow in the Home 00 0c eee Reassembling the Willow 2 Additional IMOMNAUNON 234 2 esse rare DISDOSAL 0 000 000 Technical Specifications aaa cc ee es SYMBO S AAP Mis AA PS Willow Nasal Pillows System User Manual V4 Willow Nasal Pillows System Thank you for choosing Willow Nasal Pillows System The Willow nasal pillows system is light flexible and quiet It is designed to minimize contact with your face and to maximize comfort during therapy This user guide provides you with the information you need for the correct use of your system Intended Use The Willow is intended for adult patients gt 30Kg prescribed continuous positive airway pressure or Bi level therapy and it is intended for single patient reuse in the home environment CAUTION Federal law restricts the sale of this device to sale by or on the order of a physici
4. an Medical Information Note The Willow does not contain latex PVC or DEHP materials If you have ANY reaction to any part of the system discontinue use and consult your sleep therapist WARNING and CAUTION e This system should be used only with flow generators CPAP or Bi level recommended by your physician or respiratory therapist It should not be used unless the flow generator is turned on and operating properly The vent holes should never be blocked e Explanation of the Warning Flow generators are intended to be used with special interfaces with connectors which have vent holes vent holes are located on the elbow or separate exhalation devices to allow continuous flow of air out of the interface When the flow generator is turned on and functioning properly new air from the flow generator will flush the exhaled air out through the attached exhalation port However when the flow generator is not operating eg power failure not enough fresh air will be provided through the system and exhaled air may be re breathed In this situation remove the Willow immediately e The exhaust vent flow is lower at lower system pressure see section Technical Specifications for Pressure Flow Curve details If the system pressure during expiration is too low there may not be enough exhaust vent flow to completely flush the air delivery hose of exhaled air before the start of the next inspiration e Discontinue using the Willow
5. e injury or explains special measures for the safe and effective use of the device 8 Willow Nasal Pillows System User Manual V4 Limited Warranty It is warranted that the Willow Nasal Pillows System including its components frame pillow sleeve headgear tubing and other accessories shall be free from defects in material and workmanship for a period of ninety 90 days from the date of purchase by the initial consumer To exercise the rights under this warranty contact the local authorized dealers or 3B Medical Inc 1142 N Scenic Highway Lake Wales FL 33844 USA Email info 3Bproducts com Tel 863 226 6285 Fax 863 226 6284 3B 3B Medical Inc 1142 N Scenic Highway Lake Wales FL 33844 USA Email info 3Bproducts com Tel 863 226 6285 Fax 863 226 6284
6. e tube retainer into the gap of the other end Removing the Willow To remove the Willow pull the pillow sleeve assembly away from your nose and lift the headgear off your head You do not need to loosen the headgear straps Attach both ends of the tube retainer onto the top strap Willow Nasal Pillows System User Manual V4 Disassembling for Cleaning Disconnect the flow generator tubing Hold the swivel and pull it away from the flow generator tubing Detach the panels from the pillow sleeve assembly Rotate the panel until the rectangular block lies in Detach the short tube assembly To do this hold the elbow and pull it away from the frame parallel with the gap in the frame Simply pull the panels from the frame lt gt Disassemble the pillow sleeve assembly To do this detach the clip and peel the pillow sleeve off the frame Note The short tube assembly cannot be taken apart Remove clip from frame CAUTION Do not pull on the short tube or the flow generator tubing as they may get damaged To disassemble the Willow for daily cleaning follow steps 1 3 To disassemble the Willow for weekly cleaning follow steps 1 5 Cleaning the Willow in the Home Notes e Wash your hands before cleaning the mask e Wash the headgear before first time use as the dye may run It is important to always handwash the headgear e The headgear may be washed without being disassembled
7. he gaps in panel into the headgear ring inthe same way panels separately then fold on the frame Make sure the back over to secure rectangular block is inserted into the correct side OZR Put the headgear on your Gently tighten the top strap Adjust each end of the back head and Insert the nasal overtighting may cause strap overtighting may pillows into your nostrils excess pressure on your Cause excess pressure on Make sure the top strap nose upper lips passes over the top of your head Willow Nasal Pillows System User Manual V4 Alternate the adjustment of headgear straps until they rest comfortably and rotate pillow sleeve assembly to adjust nasal pillows angle to insure that they fit comfortably inside your nostrils Connect one end of the main air tubing to your flow generator and the other end to the swivel Turn your flow generator on Take time to adjust the headgear straps angle of the pillow assembly and position of the short tube assembly to achieve a secure and comfortable fit Note Refer to your flow generator manual for details on setting and operational information If you feel an air leak readjust the angle of the nasal pillows to get a better seal If you are unable to resolve any leaks you may need an alternative pillow sleeve size Using Tube Retainer Optional Wrap tube retainer over the short tube Make sure smooth surface faces outward Thread one end of th
8. ot be push the clip onto the frame pointing upwards attached tightly to the frame to secure the pillow sleeve in place Willow Nasal Pillows System User Manual V4 SY y 7 1 Attach the short tube Check positioning markers Attach the panels to the assembly to the pillow on frame and panels are on pillow sleeve assembly sleeve assembly To do this the same side Make sure the To do this insert the push the elbow into the seal headgear panels are facing rectangular block at the ring until it clicks into place out smaller end of the panel into the headgear ring on the frame Rotate the panel to a proper position Fix the other panel in the same way Thread both ends of top Fold back the straps over to Slip the headgear on your strap and back strap through secure head and adjust the position the gaps in the panels Make sure rough surface of straps sits outside Additional Information Note For additional instruction please visit our website at www 3Bproducts com An instructional video is available for viewing under the Willow tab Reassembling the Headgear When disassembled the headgear consists of four components A Left strap B Right strap C Back strap D Top strap The left and right straps are bonded and are labeled L and R The top and back straps may be distinguished by size The top strap is the shorter of the two straps Thread the back strap and top strap through the gaps of the
9. panels and secure them with the Velcro tabs Disposal The Willow Nasal Pillows System does not contain any hazardous substances and may be disposed of with your normal household refuse 7 Willow Nasal Pillows System User Manual V4 Technical Specifications Pressure Flow Curve Dead Space Information Therapy Pressure Resistance Sound Environmental Conditions Symbols System and Packaging Pressure Fl ow Curve Mn 40 30 20 10 Flow Rate Li 4 9 14 19 24 Mask Pressure cmH20 Dead space is the empty volume of the pillow sleeve and short tube assembly up to the swivel The dead space of the WillowTM for all pillow sleeve sizes is 96 mL 4 to 20 cmH20 Drop in pressure measured average for three pillow sleeve sizes at 50 L min 1 0 cmH20 at 100 L min 3 1 cmH20 DECLARED DUAL NUMBER NOISE EMISSION VALUES in accordance with ISO 4871 The A weighted sound power level of the mask is 25 dBA with uncertainty 3 dBA The A weighted sound pressure level of the mask at a distance of 1m is 18 dBA with uncertainty 3 dBA Operating temperature 5 C to 40 C Operating humidity 10 93 relative humidity non condensing Storage and transport 20 C to 55 C Storage and transport humidity 10 93 relative humidity non condensing AN Caution consult accompanying documents LOT Lot Number User Guide AR A Indicates a Warning or Caution and alerts you to a possibl
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