Respironics Inc Murry Ridge Lane Murrysville, PA USA

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1 Respironics Inc Murry Ridge Lane Murrysville, PA USA

2 Profile Lite Youth Nasal Mask Youth Nasal Mask 1 Table of Contents 2 Package Contents 3 Intended Use 4 Warnings 6 Disposal 7 Symbols 8 Before Use 8 Cleaning Instructions 11 Removing and Attaching the Headgear 12 Replacing the Gel Spacer 13 Putting on the Mask 14 Taking off the Mask 15 Getting the Child to Wear the Mask 16 Sleep-overs 17 Specifications 18 Operating and Storage Conditions 18 Reorder Information 19 Limited Warranty Caregiver Instructions

3 2 Package Contents Youth Nasal Mask (nasal gel mask with headgear) Caregiver Instructions Smart Kids Guide A G Figure 1 C D E B F A = Gel Spacer B = Mask Gel Cushion C = Exhalation Port D = Mask Swivel E = Tubing (Connects to Device) F = Headgear Tab G = Top Strap

4 Caution: US federal law restricts this device to sale by or on the order of a physician. 3 Intended Use The Youth Nasal 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. The mask is to be used on patients 7 years or older (>40lbs/20kg) for whom CPAP or bi-level therapy has been prescribed. Important Note: An exhalation port is built into the Youth Nasal Mask so a separate exhalation port is not required. Important Note: Device pressures should be verified when used by other vendor s auto-titrating devices. Caregiver Instructions

5 4 Warnings This mask is not suitable for providing life support ventilation. The mask contains small parts which could result in a choking hazard. This mask is designed for use with CPAP or bi-level systems recommended by your health care professional or respiratory therapist. Do not wear this mask unless the CPAP or bi-level system is turned on and operating properly. Do not block or try to seal the exhalation port. Explanation of the Warning: CPAP systems are intended to be used with special masks with connectors which have vent holes to allow continuous flow of air out of the mask. When the CPAP machine is turned on and functioning properly, new air from the CPAP machine flushes the exhaled air out through the attached mask exhalation port. However, when the CPAP machine is not operating, enough fresh air will not be provided through the mask, and exhaled air may be rebreathed. This warning applies to most models of CPAP systems. Rebreathing of exhaled air for longer than several minutes can, in some circumstances, lead to suffocation. Warning A warning indicates the possibility of injury to the user or operator. Caution A caution indicates the possibility of damage to the device. Note A note places emphasis on an operating characteristic.

6 If oxygen is used with the device, the oxygen flow must be turned off when the device is 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. Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame. At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure settings, patient breathing pattern, mask selection, and the leak rate. This warning applies to most types of CPAP and bi-level machines. Some users may experience skin redness, irritation, or discomfort. If this happens, discontinue use and contact your healthcare professional. At low CPAP or EPAP pressures the flow through the exhalation port may be inadequate to clear all exhaled gas from the tubing. Some rebreathing may occur. Appropriate patient monitoring should be used as medically necessary. The gel mask is not customizable. Do not attempt to heat. Hand wash prior to first use. Inspect the mask for damage or wear (cracking,crazing, tears, cushion damage resulting in gel exposure, etc). Discard and replace any components as necessary. Use of a nasal or full face mask may cause tooth, gum, or jaw soreness 5 Caregiver Instructions

7 6 or aggravate an existing dental condition. Consult your physician or dentist if symptoms occur. If an additional exhalation device is added to the patient circuit, you may need to adjust the pressure level to compensate for the additional leak of the exhalation device. Disposal Dispose of in accordance with local regulations.

8 Symbols Symbol Description 7 Warning or Caution Prescription required Consult instructions for use Note Tip Caregiver Instructions

9 8 Before Use Hand wash mask. Read and understand the caregiver instructions. Read the child guide with the child and answer any questions they may have. Clean the patient s face. Cleaning Instructions For Multi-Patient Use: Visit or contact Respironics Customer Service at (USA or Canada only) or at to obtain Mask Disinfection Instructions. For Home Use: The mask and tubing should be cleaned daily.

10 Cleaning the Mask 1. With the headgear attached, hand wash mask (Figure 2) in warm water with a mild liquid dishwashing detergent. 9 Caution: Do not use bleach, alcohol, or cleaning solutions containing bleach or alcohol, or cleaning solutions containing conditioners or moisturizers. 2. Rinse thoroughly. Pat with a towel and air dry completely before use. 3. Inspect the mask for damage or wear (cracking,crazing, tears, cushion damage resulting in gel exposure, etc). Discard and replace any components as necessary. Cleaning the Headgear The headgear should be cleaned weekly or as needed by hand or machine wash in the gentle Figure 2 It is not necessary to disconnect the headgear for daily use and cleaning. Caregiver Instructions

11 10 cycle. Connect the headgear tabs so they do not catch other items in the laundry. Lay the headgear flat or line dry. Do not place the headgear into the dryer. Slight readjustment of the headgear straps may be needed after repeated washings. Figure 3 Inspect Mask Ports must be clear of debris and gel barrier cannot be torn.

12 Removing and Attaching the Headgear 11 To remove the headgear from the mask, undo the headgear tabs by peeling back the tabs and pulling each strap out through the slots on the mask faceplate. To attach, thread the tabs (Figure 4) through the headgear slots. The sticky side should face away from the mask. Fold the tabs back to catch the straps. The headgear is equipped with two sets of tabs (Figure 5) for better adjustment. For larger size heads, use the black tabs. For smaller size heads, use the blue tabs. The tabs that will not be used can be removed using a pair of scissors. Figure 4 Thread the tabs through the slots then fold back to catch the straps. Figure 5 Two sets of tabs for better adjustment Caregiver Instructions

13 12 Replacing the Gel Spacer Inspect the forehead gel spacer for damage. If the gel material is exposed due to puncture or tear, discard the damaged gel spacer and replace the gel spacer (Figure 6) with a new one. 1. Remove the top headgear straps. 2. Squeeze the hook tabs on the bottom of the spacer until the hooks clear the slot. 3. Swing the bottom of the gel spacer away from the forehead arm. The top tabs will disengage. Figure 6 Replace Gel Spacer Squeeze hook tabs inward and swing the bottom of the spacer out and away. 4. Place the top tabs of the new gel spacer into the top slot.

14 5. Press the bottom tabs into the bottom slot until the hooks engage the slot. 13 Give a gentle tug to make sure the new gel spacer is connected to the forehead arm. Putting on the Mask The patient should be shown these steps and should demonstrate the ability to perform each of these unassisted. 1. Hold the mask lightly against the patient s face and pull on the headgear (Figure 7) over the patient s head. If needed, undo or loosen the headgear tabs on the bottom straps. 2. Connect the CPAP or bi-level tubing to the exhalation elbow on the mask. Figure 7 Pull on Headgear Easily goes on over the patient s head. Caregiver Instructions

15 14 3. Turn on the CPAP or bi-level system. 4. Instruct the patient to lie down (Figure 8) and breathe in and out normally through his nose, keeping his lips closed. 5. Unhook the headgear tabs and gradually tighten the straps until the mask has minimal leaks and fits comfortably. Figure 8 Lie Down Close lips and breathe in and out normally through the nose. Taking Off the Mask Because the headgear stretches, you should be able to slide the mask (Figure 9) over the patient s head. If necessary, undo the headgear tabs on the bottom straps.

16 The patient should practice taking off the headgear in front of you and a mirror until they can remove the mask and headgear without supervision. 15 Getting the Child to Wear the Mask Since adults need time to adjust to getting CPAP or bi-level therapy, it is almost certain that the child will also need time to adjust. Therefore, we offer the following tips. Be patient and give encouragement. Let the child play with the mask, take it apart, and put it back together. Begin working with the child during the day when they are more alert. After he becomes comfortable wearing the mask Figure 9 Slide the Mask The headgear stretches, but undo the bottom headgear tabs if necessary. Comfort Tip! DO NOT overtighten the straps. Overtightening can cause or worsen leaks. Caregiver Instructions

17 16 and receiving therapy during the day, it should become easier toward bedtime hours. Use entertainment media as a way to distract the child (radio, television, favorite movie or game). Consider a reward system (similar to potty training). Sleep-overs Before allowing the child to host a sleep-over or to sleep over at a friend s house, speak with the parents. This will help the household of the friend understand the need for CPAP therapy, and help your child to feel more comfortable.

18 Specifications 17 Warning: The technical specifications of the mask are provided for your healthcare professional to determine if it is compatible with your CPAP or bi-level therapy device. If used outside these specifications, or if used with incompatible devices, the mask may be uncomfortable, the seal of the mask may not be effective, optimum therapy may not be achieved, and leak, or variation in the rate of leak, may affect device function. Intentional Leak 30 Caregiver Instructions

19 18 Pressure Drop cm H 2 O (hpa) 50 SLPM 100 SLPM Youth Mask:.1.4 Deadspace 90 ml Operating and Storage Conditions Operating: +41º to +104º F (+5º to +40º C) 5% to 95% relative humidity, non-condensing Storage: -4º to +140º F (-20º to +60º C) 15% to 95% relative humidity, non-condensing Reorder Information REF Headgear Youth Nasal Mask and Visit for a complete list of products and reorder numbers, or contact Customer Service at (USA or Canada only) or at to obtain a product catalog (REF ).

20 19 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 ). If the Product fails under normal conditions of use during the Warranty Period and the Product is returned to Respironics within the Warranty Period, Respironics will replace the Product. This warranty is non-transferable and only applies to the original owner of the Product. The foregoing replacement remedy will be the sole remedy for breach of the foregoing warranty. This warranty does not cover damage caused by accident, misuse, abuse, negligence, alteration, failure to use or maintain the Product under conditions of normal use and in accordance with the terms of the product literature, and other defects not related to materials or workmanship. This warranty does not apply to any Product that may have been repaired or altered by anyone other than Respironics. Respironics disclaims all liability for economic loss, loss of profits, overhead, or indirect, consequential, special or incidental damages which may be claimed to arise from any sale or use of the Product. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. THIS WARRANTY IS GIVEN IN LIEU OF ALL OTHER EXPRESS WARRANTIES. Caregiver Instructions

21 20 IN ADDITION, ANY IMPLIED WARRANTY, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, IS SPECIFI- CALLY DISCLAIMED. SOME STATES DO NOT ALLOW DISCLAIMERS OF IMPLIED WARRANTIES, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY ALSO HAVE OTHER RIGHTS, WHICH VARY FROM STATE TO STATE. To exercise your rights under this limited warranty, contact your local authorized Respironics, Inc. dealer or Respironics, Inc. at 1001 Murry Ridge Lane, Murrysville, Pennsylvania 15668, (USA and Canada only) or Koninklijke Philips Electronics N.V. All rights reserved.

Instructions for Use. Amara View minimal contact full-face mask

Instructions for Use. Amara View minimal contact full-face mask Amara View minimal contact full-face mask Instructions for Use Intended Use This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single