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BMC iVolve F1A, User Manual, Page: 2 / 15

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iVolve F1A Full Face Mask User Manual V2.0

 

 

 

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Table of Contents 

iVolve F1A Full Face Mask ............................................................ 1 

Intended Use ................................................................................. 1 

Before Using the Mask .................................................................. 2 

Components of the iVolve F1A Full Face Mask ............................ 4 

Getting the Right Cushion Size ..................................................... 5 

Fitting the Mask ............................................................................. 6 

Disassembling the Mask ............................................................... 7 

Cleaning the Mask at Home .......................................................... 8 

Reprocessing the Mask between Patients .................................... 9 

Reassembling the Mask ................................................................ 9 

Troubleshooting ........................................................................... 10 

Technical Specifications .............................................................. 11 

Storage ........................................................................................ 12 

Disposal ....................................................................................... 12 

Symbols ....................................................................................... 12 

Limited Warranty ......................................................................... 13 

 

Summary of Contents for iVolve F1A

Page 1: ...English iVolve F1A Full Face Mask User Manual 0123 ...

Page 2: ...the Mask 2 Components of the iVolve F1A Full Face Mask 4 Getting the Right Cushion Size 5 Fitting the Mask 6 Disassembling the Mask 7 Cleaning the Mask at Home 8 Reprocessing the Mask between Patients 9 Reassembling the Mask 9 Troubleshooting 10 Technical Specifications 11 Storage 12 Disposal 12 Symbols 12 Limited Warranty 13 ...

Page 3: ...f your mask Intended Use The iVolve F1A Full Face Mask channels airflow non invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure CPAP or bi level system The iVolve F1A Full Face Mask is to be used by adult patients 66 lb 30 kg for whom positive airway pressure therapy has been prescribed intended for single patient re use in the home environm...

Page 4: ... exhaled port may be inadequate to clear all exhaled gas from the tube Some rebreathing may occur To minimize the risk of vomiting during sleep the patient should avoid eating or drinking for three hours before using the mask This mask is not recommended if the patient is taking a prescription drug that may cause vomiting Do not use the mask without the Non Rebreathing Valve in place This mask sho...

Page 5: ...seal and comfort of the mask may not be effective optimum therapy may not be achieved and leak or variation in the rate of leak may affect the function of the flow generator Stop using the iVolve F1A Full Face Mask and consult your physician or sleep therapist if you have ANY adverse reaction to the use of the mask Refer to your flow generator manual for details on settings and operational informa...

Page 6: ...iVolve F1A Full Face Mask User Manual V2 0 4 13 English Components of the iVolve F1A Full Face Mask Components of the iVolve F1A Full Face Mask ...

Page 7: ...e following drawing describes the different features of face and the length of the face H you need to measure The masks are available in three different sizes Choose the appropriate size according to the table below Getting the Right Cushion Size H H mm Size 80 H 90 S 90 H 100 M 100 H 115 L ...

Page 8: ...re Pull the upper straps over your head and hold the mask against your face Bring the lower straps below your ears and loop them into the lower hooks on the headgear frame 4 5 6 Adjust the upper headgear straps evenly until they are comfortable Adjust the lower headgear straps evenly until they are comfortable Connect the air tubing to the swivel Then turn on the device and adjust the mask to the ...

Page 9: ... tubing Detach the headgear straps by unthreading the upper and lower straps from the hooks of the headgear frame Remove the elbow assembly from the cushion frame and then pulling away the headgear frame 4 Remove the thin pad and cushion from the cushion frame and detach the cushion from the thin pad ...

Page 10: ...If any visible deterioration of a component is apparent cracking crazing tears etc the component should be discarded and replaced Daily After Each Use To optimize the mask seal facial oils should be removed from the cushion before use Handwash the mask by gently rubbing in warm 30 C water using mild soap or diluted dishwashing detergent If the pick off port cover requires cleaning use a soft brist...

Page 11: ...he BMC website www bmc medical com If you do not have internet access please contact your BMC representative Reassembling the Mask 1 2 3 Fit the cushion into the thin pad to form a cushion assembly Lock the cushion assembly securely into the cushion frame Gently push the headgear frame onto the cushion frame 4 5 Insert the elbow assembly to the cushion frame Attach the headgear straps to the frame...

Page 12: ...ing to the instructions in Reassembling the Mask section Mask s thin pad is misaligned or creased on the face Make sure the thin pad is properly aligned according to the instructions in Reassembling the Mask section Make sure the thin pad has no creases Check the cushion and thin pad and reposition the mask over your face Mask s cushion and thin pad may be dirty Clean the cushion and thin pad acco...

Page 13: ...e The inspiratory resistance of the mask in combination with the Non Rebreathing Valve is 0 6 cmH2O per L S The expiratory resistance of the mask in combination with the Non Rebreathing Valve is 1 7 cmH2O per L S The Non Rebreathing Valve open to atmosphere pressure 0 9 cmH2O The Non Rebreathing Valve closed to atmosphere pressure 1 0 cmH2O Sound DECLARED DUAL NUMBER NOISE EMISSION VALUES in accor...

Page 14: ...roughly clean and dry before storing it for any length of time Store the mask in a dry place out of direct sunlight Disposal The iVolve F1A mask does not contain any hazardous substances and may be disposed of with your normal household refuse Symbols System and Packaging Caution consult accompanying documents Indicates a Warning or Caution and alerts you to a possible injury or explains special m...

Page 15: ...ial consumer To exercise the rights under this warranty contact the local authorized dealers The expected service life of iVolve F1A Full Face Mask is one year MANUFACTURER BMC MEDICAL CO LTD Room 110 Tower A Fengyu Building No 115 Fucheng Road Haidian 100036 Beijing PEOPLE S REPUBLIC OF CHINA Tel 86 10 51663880 Fax 86 10 51663880 Ext 810 EU AUTHORISED REPRESENTATIVE Shanghai International Holding...

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