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Summary of Contents for Respironics Profile Lite
- Page 1 Profile Lite 1067778 JDH 04/9/2010 INSTRUCTIONS FOR USE © 2010 Koninklijke Philips Electronics N.V. All rights reserved.
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Page 2: Table Of Contents
ProfileLite Nasal Gel Mask Table of Contents Intended use Warnings symbols cleaning Instructions system one resistance control Putting on the Mask and Headgear removing the Mask and Headstrap replacing the Gel spacer reforming the Mask comfort tips Disposal specifications Limited Warranty reorder Information InstructIons for use... - Page 3 ProfileLite Nasal Gel Mask Figure 1 A = Gel Forehead Spacer B = Mask Cushion C = Exhalation Port (Do not block) D = Removable Port Cap ProfileLite...
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Page 4: Intended Use
US federal law restricts this device to sale by or on the order of a physician. Intended Use the Profile Lite nasal Gel Mask is intended to provide an interface for application of cPAP or bi-level therapy to patients. the mask is for single patient use in the home or multi-patient use in the hospital/ institutional environment. -
Page 5: Warnings
Warnings: • this mask is not suitable for providing life support ventilation. • this mask is designed for use with cPAP Warning or bi-level systems recommended by your health care professional or respiratory A warning indicates the therapist. Do not wear this mask unless the possibility of injury to cPAP or bi-level system is turned on and the user or operator. - Page 6 not operating. Explanation of the Warning: When the device is not in operation, and the oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulate within the device enclosure. oxygen accumulated in the device enclosure will create a risk of fire. •...
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Page 7: Symbols
Symbols Symbol Description General Caution or Warning Consult instructions for use System One Resistance Control Note Does not contain natural rubber latex ProfileLite... -
Page 8: Cleaning Instructions
Mask cleaning and Disinfection Instructions to reprocess the mask between patients. these instructions can be obtained by visiting www.sleepapnea.com or contacting respironics customer service at 1-800-345-6443 (usA or canada) or 1-724-387-4000. InstructIons for use... -
Page 9: System One Resistance Control
System One Resistance Control this mask uses the system one resistance control setting . this symbol may appear on your therapy device. this symbol represents the level of mask resistance compensation. Match the setting to the mask if appropriate. Important Notes: •... -
Page 10: Removing The Mask And Headstrap
exhalation elbow. turn the cPAP or bi-level system on. Lie down and breathe normally through your nose, keeping your lips closed. unhook the straps and gradually tighten Figure 3 them until the mask has minimal leaks and fits comfortably. A = Use blue tabs for Note: the headstrap has two sets of tabs for smaller sized heads better adjustment. -
Page 11: Replacing The Gel Spacer
Replacing the Gel Spacer replace the gel spacer if it is punctured, leaking or damaged. see the last page of these instructions for order information. Before attaching a new gel spacer, remove the headgear from the mask following the Figure 4 instructions below. - Page 12 Caution: Do not heat the mask by placing it into the microwave or conventional oven. the mask will be damaged. using tongs or a similar utensil, slowly place the mask into the water being careful to keep the water from spilling over (figure 7).
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Page 13: Comfort Tips
Comfort Tips • clean your face and mask thoroughly before each use. • Make sure the mask is the correct size for your face. • Do not overtighten the headgear. overtightening can irritate your face, increase leaks, or cause damage to the mask. •... - Page 14 Intentional Leak Pressure vs. Leak Rate Profile Lite Profile Lite w/ 22mm elbow Pressure cmH o (hPa) InstructIons for use...
- Page 15 Pressure Drop cm H O (hPa) 50 sLPM 100 sLPM Large Deadspace ≤ 281 cc. Storage Conditions temperature -4° f to 140° f (-20° c to 60° c) 15% to 95% rH, non-condensing ProfileLite...
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Page 16: Limited Warranty
LIMITED WARRANTY Respironics, Inc. warrants that its mask systems (including mask frame and cushion) (the “Product”) shall be free from defects of workmanship and materials for a period of ninety (90) days from the date of purchase (the “Warranty Period”). -
Page 17: Reorder Information
1002373 Profile Lite Mask, L 1004292 Gel retrofit spacers, s 1004291 Gel retrofit spacers, L 1008869 Gel retrofit spacers, XL 1004086 Profile Lite Mask w/headstrap, P 1004087 Profile Lite Mask w/headstrap, s 1004088 Profile Lite Mask w/headstrap, Ms 1004089 Profile Lite Mask w/headstrap, M...
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