PHILIPS Respironics TrueBlue User manual

1
TrueBlue
Instructions for Use
Intended Use
The TrueBlue 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 (>66lbs/30kg)
for whom CPAP or bi-level therapy has been prescribed.
Notes:
• An exhalation port is built into this mask so a separate exhalation port is not required.
• This mask is not made with natural rubber latex or DEHP.
Caution
U.S. Federal law restricts this device to sale by or on the order of a physician.
Symbols
Warning or Caution Note Tip
Consult Instructions for
Use
Not Made With Natural
Rubber Latex
System One Resistance
Control
Warnings
• This mask is not suitable for providing life support ventilation.
• 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.
• 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.
ENGLISH

2
• 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.
• 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.
• The gel mask is not customizable. Do not attempt to heat.
• Use of a nasal or full face mask may cause tooth, gum, or jaw soreness or aggravate an existing dental
condition. Consult your physician or dentist if symptoms occur.
Before Use Read and Understand the Instructions
• Hand wash the mask.
• Wash your face.
• Do not apply moisturizer/lotion to your face or hands prior to handling/wearing the mask.
Cleaning Instructions
Hand wash the mask before first use and daily. The headgear should be hand washed
weekly, or as needed. The headgear does not need to be removed for daily cleaning of the
mask. To disassemble the mask for cleaning, please refer to the Removing and Attaching the
Mask Cushion later in this document.
1. Hand wash the mask and headgear in warm water with a mild liquid dish washing
detergent.
Caution: Do not use bleach, alcohol, cleaning solutions containing bleach or alcohol, or
cleaning solutions containing conditioners or moisturizers.
Caution: Any deviation from these instructions may impact the performance of the
product.
2. Rinse thoroughly with water and air dry out of direct sunlight. Make sure the mask is dry
before use. Lay the headgear flat or line dry. Do not place the headgear into the dryer.
Warning: Inspect the mask for damage or wear (cracking ,crazing, tears, cushion damage
resulting in gel exposure, etc). Discard and replace any components as necessary.
Institutional Disinfection
For multi-patient use in the hospital/institutional environment, use the Disinfection Guide
to reprocess the mask between patients. These instructions can be obtained by visiting us
online at www.philips.com/respironics or by contacting Philips Respironics Customer Service
at 1-800-345-6443 (USA or Canada) or at 1-724-387-4000.
Figure 1
A = Exhalation Chip (do not block holes or
remove chip)
B = Forehead Support Bracket and Gel
Forehead Pad
C = Headgear Crown Tab
D = Headgear Crown Strap
E = Headgear Side Strap
F = Headgear Lower Strap
G = Mask Cushion and Flap
H = Spring
I = Swivel
J = Headgear Clip
A
B
C
D
E
F
G
H
I
J

3
Philips Respironics System One Resistance Control
Your mask when combined with a Philips Respironics System One
device, provides optimal resistance compensation. This mask value
is X1 and should be set by your provider.
Notes:
• Compare the mask to the device. See your device manual if the
values do not match.
• System One is not compatible with masks that use a separate
exhalation device.
Putting on the Mask
1. Disconnect one headgear clip before putting on the headgear
(Figure 2) by turning the clip outward, just like you would turn
a key.
2. Before putting on the mask, connect the flexible tubing from
your therapy device to the swivel on the mask. Slide the
headgear on over your head.
3. Turn on the airflow.
4. Hold the mask cushion over your nose and reconnect the
headgear clip after you have the headgear in position (Figure 3).
Achieving the Right Fit
1. Adjust the headgear side straps evenly so the forehead pad is
resting comfortably on the forehead (Figure 4). To adjust,
peel the headgear tabs away from the headgear straps,
evenly adjust straps, then press tabs against the headgear
straps to reattach.
2. Adjust the headgear lower straps evenly. To adjust, peel
the headgear tabs away from the headgear straps, evenly
adjust straps, then press tabs against the headgear straps to
reattach. The mask should rest comfortably against your face.
3. Adjust the headgear crown strap, if necessary. If the
headgear side straps are resting on your ears, adjust the
headgear crown strap to lift the straps slightly off your ears
(Figure 5).
Note: Do not overtighten the headgear crown strap as it
may cause the headgear to bunch.
4. Minimal leaks are acceptable. Small adjustments are needed
to eliminate excessive leaks. We suggest performing the
adjustments in the following order:
a) If leaks occur, reseat the mask by pulling the mask faceplate
directly away from your face and set it gently back into place
(Figure 6). This allows the cushion to create a new seal on the
face. Do not pull the mask by the elbow.
b) For leaks around the eyes, adjust the side straps.
c) For leaks around the top lip, adjust the lower straps (Figure
7).
d) Repeat the sequence as necessary.
5. Lay down and assume different sleeping positions while moving your head around. If
there are any air leaks, make any final adjustments. Some air leakage is normal.
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
Figure 7

4
Note: The spring should only be slightly compressed when final adjustments have been
made. The spring is intended to allow the mask to float and self-adjust to the face. If the
mask is overtightened, it can hinder the mask’s performance and seal.
Note: Do not overtighten the headgear.
Comfort Tips
• The headgear should fit both loosely and comfortably. If your skin bulges around the
mask, loosen the headgear.
• Reseat the mask. Pull the mask by the sides of the faceplate directly away from the face
then gently set it back into place.
• For pressure at the bridge of the nose, loosen the side straps.
• For pressure on the top lip, loosen the lower straps.
• If the headgear side straps are lying on your ears, adjust the headgear crown strap to
slightly lift the headgear off your ears. The headgear should lay flat against your head. If it
is bunching, adjust the headgear crown strap to allow the headgear to flatten.
• To help stabilize the mask, adjust the headgear crown strap. This will help keep the mask
from sliding down on the face.
Removing the Mask
Disconnect the lower straps by removing one or both headgear clips.
Slide the headgear over your head.The entire headgear stretches for easy removal.
Removing and Attaching the Mask Cushion
Removing:
1. Pull outward on the three attachment tabs on each side of the
mask cushion until this cushion separates from the mask frame
(Figure 8).
2. Remove the gel cushion and flap to allow for cleaning.
Attaching:
1. To replace the gel cushion, place the gel cushion inside the flap
and press into place.
2. Place the flap and gel cushion over the spring and press down
along the sides and bottom of the flap until it clicks into place. If
the spring is not correctly seated inside the flap, you may hear a
whistling noise when the airflow is applied.
Removing and Attaching the Forehead Pad
1. To remove the gel forehead pad, simply grasp the pad and
peel it away from the forehead support bracket (Figure 9).
2. To attach, place the gel forehead pad into the forehead
support bracket. Line up the tabs and press the forehead gel
cushion into place. The gel pad is correctly in place when the
tabs on the forehead bracket are over the white base of the
gel pad.
Figure 9
Figure 8

5
Specications
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. The pressure flow curve shown
below is an approximation of expected performance. Exact measurements may vary.
Pressure Flow Curve
10
20
30
40
50
60
70
Flow Rate (SLPM)
0
10
0 5 10 15 20 25 30
Pressure cm H2O
Resistance
Drop in Pressure at
50 SLPM 100 SLPM
All sizes 0.1 cm H2O 0.7 cm H2O
Deadspace Volume
Petite 88 mL
Small 108 mL
Medium 108 mL
MediumWide 124 mL
Large 122 mL
Sound Levels
A-weighted Sound Power Level 32 dBA
A-weighted Sound Pressure Level at 1 m 23 dBA
Disposal
Dispose of in accordance with local regulations.
Storage Conditions
Temperature: -4º to 140º F (-20º to +60º C)
Relative Humidity: 15% to 95% non-condensing