CPAP SILICONE
FULL FACE MASK
INtENdEd USE
The CPAP/VPAP Mask is intended to be used for patients who have
been prescribed CPAP or VPAP therapy and are under the specific
direction of a physician. It is used in conjunction with continuous
positive airway pressure (CPAP/VPAP) devices in home, hospital and
Institutional environments.
CONtrAINdICAtIONS
This mask may not be suitable for patients with the following conditions:
impaired cardiac sphincter function, excessive reflux, impaired cough
reflex and hiatal hernia. It should not be used if the patient is
unresponsive, obtunded, unable to remove the mask, or uncooperative.
WArNINgS
• This mask should only be used with CPAP systems recommended
by your physician or respiratory therapist.
• Do not use this mask unless the CPAP or VPAP system is turned
on and operating properly.
• Never block the mask’s vent holes or exhalation port.
Note: CPAP systems are intended to be used with special masks
with vent holes in either the connectors or the mask that allow
continuous flow out of the mask. When the CPAP device is turned on
and functioning properly, new air from the CPAP device flushes the
exhaled air out through the mask’s exhalation port. However, when the
CPAP device is not operating, enough fresh air will not be provided
through the mask and exhaled air may be rebreathed. Rebreathing of
exhaled air for several minutes can in some circumstances lead to
suffocation.
• If oxygen is used with the CPAP system, the oxygen flow must be
turned off when the CPAP device is not in operation.
Note: When the CPAP device is not in operation and the oxygen flow
is left on, oxygen delivered into the ventilator tubing may accumulate
within the CPAP device’s enclosure and create a risk of fire.
Note: At a fixed flow rate of supplemental oxygen, the inhaled
oxygen concentration will vary depending on the pressure setting,
patient’s breathing pattern and leak rate.
• Do not smoke if oxygen is in use.
• Contact a health care professional in the event chest discomfort,
shortness of breath, stomach distention, belching, or severe
headache are experienced.
• Avoid eating or drinking three hours before using this mask to
minimize the risk of vomiting during sleep.
• Do not use this mask if you are taking medication that may cause
vomiting.
CautioN: At low CPAP pressures the flow through the exhalation
port may be inadequate to clear all exhaled gas from the tubing and
some rebreathing may occur.
• Must only be used by persons who have received adequate
training from qualified medical personnel.
• Used in combination with other medical devices might alter the
performance of the mask.
CAUtION
USA federal law restricts this device to sale by or on the order of a
physician.
The use of bleach, chlorine, alcohol or aromatic-based solutions may
cause hardening and reduce the life of the product.
FEAtUrES
• One piece molded silicone rubber; small, light and comfortable.
• Clear mask allows a good view of mouth and nasal area.
• Low dead space results in low CO
2
build up.
• Dual swivel 360° rotating elbow and tubing connector.
• Headgear with Velcro fasteners provides maximum versatility and
movement.
CLEANINg INStrUCtIONS
• Detach headgear from mask.
• Handwash gently with mild soap and warm water (30˚C), rinse the
mask and components thoroughly. Note - Headgear should only
be hand washed with mild soap by gently rubbing in warm water at
30°C. No washing machine, no ironing.
• Allow mask and components to air dry before reusing. Do not
place in direct sunlight.
• Replace mask if there are cracks, tears or excessive discoloration.
• The D100 is dishwasher safe if placed in top rack.
• important Note: When removing the mask for cleaning, there
is no need to unfasten the Velcro tabs. Simply unclip the lower
buckles and remove the upper headgear straps from the slots
in the mask frame. Replace after cleaning.
• To remove the mask and headgear, simply unbuckle both
buckles (A3 & A4) from the mask frame and pull off the mask.
• To reuse the mask and headgear, simply place upper headgear
over head and hook both buckles.
• This product does not require maintenance.
Please follow assembly instructions below:
DeVilbiss
®
is a registered trademark of
DeVilbiss Healthcare.
© 2013 DeVilbiss Healthcare LLC. 08.13
All Rights Reserved. A-D100F Rev. B
EN
ReF:
Date of
Manufacture:
Use By:
Consult instructions for use
EC
REP
Manufactured for
DeVilbiss Healthcare LLC
100 DeVilbiss Drive
Somerset, PA 15501-2125 • USA
800-338-1988 • 814-443-4881
eu Representative
mdi europa GmbH
Langenhagener Str. 71
D-30855 Langenhagen, Germany • Tel: +49 511 39089530
Email: [email protected] • internet: www.mdi-europa.com
DeVilbiss Healthcare GmbH
Kamenzer Straße 3
68309 Mannheim GeRMANy
+49-621-178-98-230
Manufactured by HSiNeR Co., Ltd
312, Jhongshan Rd., Shengang Dist
Taichung City 429, Taiwan
Tel: 886-4-25152480 • Fax: 886-4-25152482
Email: [email protected] • Web Site: http://www.hsiner.com
2
Identify headgear fastening positions
on the mask.
5
Pull the upper headgear strap A2
through the slot B2 on the mask,
making sure the Velcro faces outward
Fasten the Velcro tab.
3
Pull the upper headgear strap A1
through the slot B1 on the mask,
making sure the Velcro faces outward.
4
Fasten the Velcro tab.
Place headgear with Velcro side
down on a flat surface. Detach 2
Velcro tabs on A1 & A2.
1
Place the headgear over your head
and adjust both upper headgear
straps to a comfortable tension.
6
Hook the plastic buckle A3 onto B3
and A4 onto B4 on mask frame.
7
Adjust both lower headgear straps A3
& A4 to a comfortable tension.
9
Readjust both upper headgear straps
A1 & A2 to a comfortable tension.
8
ensure the overhead strap is in
proper position to avoid slippage.
10
a1
a2
a3
a4
B1
B2
B3
B4
LATEX
Not made with natural rubber latex.
Therapy Pressure (cmH2O)
Exhaust Flow Rate at Given Therapy Pressure
Exhaust F
lo
w
R
at
e (LP
M)
Storage relative humidity: < 85%
Operation temp: -18°C - 50°C
Storage temp: -40°C - 60°C
ReSiStaNCe
(cmH
2
o)
50LPM 100LPM
D100F
0.24
0.62
MoDeL
VoLuMe (ML)
D100F-S
296.6
D100F-M
339.4
D100F-L
367.8
Expected Service Life
• Mask Frame Components = 6 months
• Headgear = 3 months
• Mask Cushions = 3 months
Size: Assembled Mask (without Headgear): 161mm (H), 90mm (W),
69mm (D)
Weight: Mask incl. Headgear: 122g; Headgear: 31g
Materials used:
Mask frame: Polycarbonate (PC))
Forehead Pad: Silicone
Headgear: Nylon + Spandex
Cushions: Silicone
The mask system does not contain latex materials. This product does not
contain PVC or Phthalates.
