ORACLE™ 452 ORAL MASK
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The Oracle™ Oral Mask is intended for multiple patient or single patient adult use
by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level
ventilator treatment. For optimal humidification it is recommended that you use the
Oracle™ Oral Mask with the Fisher & Paykel Healthcare SleepStyle™ 600 Series CPAP
system with ThermoSmart™ Technology.
Fitting Your Mask
Refer to the mask assembly diagram.
1) Attach Headgear by re-connecting one of the clips (J).
2) Pull the SnapFlap™ Cover (A) back to the retracted position.
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3) Insert the Silicone Seal (B) into the mouth, one side at a time. It should sit in the gum region
between the cheeks and the teeth. Move your lips around so they fit comfortably all the
way over the Silicone Seal.
4) Return the SnapFlap™ Cover (A) back to its normal position, and adjust the mask tightness
by rotating the Dial
5) With Headgear (I) sitting loosely around base of neck, re-connect clip.
6) Adjust Headgear with Velcro™ tab (l1) to remove slack.
7) Use Nasal Plugs (H) for at least the first two weeks of use. Refer to Nasal Plug Instructions.
8) Connect to CPAP/Bi-Level machine set at prescribed pressure.
Fitting Tips
If the mask leaks around the teeth, tighten the SnapFlap™ Cover
If problems persist, try using the large Silicone Seal, which is included in your Oracle™
Mask box
It is recommended to use the Headgear with your Oracle™
and performance. However, if preferred, it is optional to discontinue use of Headgear.
Do not overtighten Headgear.
To release clip, simply pull on the Easy-Release Cord (l2).
If discontinuing use of Headgear, simply remove by unhooking both clips from SnapFlap™
Cover.
PATIENT INSTRUCTIONS FOR USE
(C) as shown.
.
(A) by rotating the Dial (C).
Oral Mask for optimum comfort
Oral
K
I
G
A
F2
C
F1
I2
I1
B
F
J
D
E
Using Your Mask
Oral CPAP/Bi-Level bypasses the nasal airway and requires optimum humidity.
For best results, use with Fisher & Paykel Healthcare SleepStyle™ 600 Series CPAP
system with Thermosmart™ Technology at the following settings:
Comfort Setting 3
Climate Setting 3
Heated Humidification MUST be used in conjunction with the Oracle™
1) Ensure water chamber is filled.
2) Breathe through your mouth only.
3) Use nasal plugs for at least the first two weeks.
Oral Mask.
Dryness
If you are using the SleepStyle™ 600 Series CPAP system and experiencing a dry
mouth, try the following:
1) Turn the comfort up one setting per night until a slight misting occurs in the Flexitube (D).
2) Alternatively if you find there is a high level of moisture build up in the tube, decrease the
comfort by one setting at a time until only slight misting occurs in the Flexitube
3) If you are still experiencing dryness, it could be due to a small air leak out of the nose. Nasal
Plugs
(H) will restrict this leak and help to retain some moisture in your mouth.
This should help you to achieve an optimum level of humidity and increase the comfort of your
therapy.
If you are experiencing a dry mouth and not using the SleepStyle™ 600 Series CPAP
system, try the following:
1) Increase the humidity on your machine.
2) If you still experience dryness, it could be due to a small air leak out of the nose. Nasal Plugs
(H) will restrict this leak and help to retain some moisture in your mouth.
(D).
E
S
P
T
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Nasal Plugs
Nasal Plugs are used to aid in the training of natural mouth breathing. It is
optional to discontinue use after the first two weeks. However, use Nasal Plugs if
H
you experience any of the following:
If discontinuing use of Nasal Plugs, replace the Non-rebreathing Valve
female swivel
Instructions for Use
1) Your Nasal Plugs (H) come in three sizes, S / M / L.
2) Insert medium sized silicone Nasal Plugs into nose so that the base of the plugs are just
inside the nostrils.
3) The plug should fit comfortably inside the nose and should seal off the flow of air.
If not content, try the other sizes.
4) Use the Oracle™
Oral dryness Nasal leak Poor sleep Quality
(K).
Oral Mask as you normally would, with the Nasal Plugs inserted.
(E) with the provided
Oracle™
Exhaust Flow (l/min)
452 Oral Mask Exhaust Flow
Assembling Your Mask
Your Oracle™ Oral Mask comes assembled and ready to use. However, when you
need to clean your mask follow these instructions for reassembly.
1) Insert the flat end of the Centre Body (G) into the Silicone Seal (B). Ensure it is pulled up over
all of the plastic lugs properly.
2) Orient SnapFlap™ Cover (A) into position shown. Rotate Dial (C) to screw onto Centre Body (G).
3) Connect Elbow (F) to the Centre Body (G) and the Flexitube (D) to the Elbow (F).
4) Connect the Non-Rebreathing Valve (E) to the Flexitube (D).
Cleaning Your Mask At Home
To ensure continuing safety and comfort for your Oracle™
Before first use:
1) Hand wash the Headgear in pure soap dissolved in lukewarm water. Do not soak for longer
than
10 minutes, then rinse in fresh water and allow to air dry out of direct sunlight.
Before each Use:
1) Inspect the mask for deterioration. Do not use if damaged.
2) Inspect the Non-Rebreathing Valve (E). Ensure the silicone flaps are present and undamaged.
After each Use:
1) Disassemble the Silicone Seal (B) & SnapFlap™
2) Wash all parts except the Headgear (I) and Diffuser (F1) in pure soap dissolved in lukewarm
water. Do not soak for longer than
out of direct sunlight.
3) Alternatively, the Silicone Seal (B) may be soaked for 10 minutes in a clean solution of
approximately 30 fl oz (
fresh water and allow to air dry out of direct sunlight.
NOTE: Do NOT immerse Elbow (F) unless Diffuser material (F1) has been removed.
The Diffuser
becomes noisy or deteriorates. It should last two to three months. Small dots may
the Diffuser
with, or without the Diffuser
Every 7 Days:
1) Hand wash the Headgear in pure soap dissolved in lukewarm water. Do not soak for longer
Caution:
(F1) should not be washed or rinsed. Simply replace it with a new diffuser if it
(F1) – these do not affect its performance. The Oracle™
than
10 minutes, then rinse in fresh water and allow to air dry out of direct sunlight. It is not
necessary to remove the Clip
Do not soak the mask for longer than 10 minutes.
Do not wash the mask in the dishwasher.
Do not clean the mask with products containing alcohol, chlorine, antibacterial agents or
bleach.
Do not store the mask in direct sunlight.
The above actions may deteriorate or damage the mask and shorten its life.
If your Oracle™
1L) of water and 2 fl oz (50mL) of antiseptic mouthwash. Rinse in
(F1) and Diffuser Cap (F2).
(H) from the headgear when washing.
Oral Mask weakens or cracks, discontinue use immediately.
The Oracle™ Oral Mask and accessories are Latex free.
Cover
(A) from the Centre Body (G).
10 minutes, then rinse in fresh water and allow to air dry
Oral Mask:
Oral Mask may be used
appear on
Oxygen/Pressure Port Connector
If pressure readings and/or additional oxygen are required, an Oxygen/Pressure
Port Connector is available. (Product 900HC452)
1) Connect the large end of the Connector (T) to the Non-Rebreathing Valve (E) and the small
end of the connector to the main breathing tube
2) Open the Port Cap(s) (P) and place the Pressure and/or Oxygen Tube (S) firmly over the
Port(s).
The two Ports are identical; either Port may be used for oxygen or pressure measurement.
Only remove the Port Cap from Ports that are being used.
Note: 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.
Warning: If oxygen is used with this CPAP/Bi-Level machine, the oxygen flow must be turned
off when the CPAP/Bi-Level machine is not operating.
Explanation of Warning: When the CPAP/Bi-Level device is not in operation, and the oxygen
flow is left on, oxygen delivered into the ventilator tubing may accumulate within the CPAP/
Bi-Level machine enclosure. Oxygen accumulated in the CPAP/Bi-Level machine enclosure
will create a risk of fire.
Warning: Do not smoke while using or in the vicinity of someone using oxygen with this
mask.
Warning: Do not use Polyvinyl Chloride (PVC) Pressure and/or Oxygen tubing. Use silicone
tubing instead
Explanation of Warning: Contact with PVC can cause premature cracking of ports.
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(R) .
Technical Specifications
Exhaust Flow Information
All masks for CPAP and Bi-Level have exhaust flow holes to expel the air that you exhale from
the mask. The Oracle™ Oral Mask incorporates the unique Fisher & Paykel Healthcare Diffuser
system that is designed to diffuse the air that is expelled from the mask. This noticeably
reduces draft and noise.
The Diffuser does not significantly change the amount of air flowing from the mask, therefore
the mask can be used with or without the Diffuser. It is important that these vents are not
blocked by any object. This controlled leak ensures all exhaled CO
Pressure (cmH
Flow (l/min) 16 22 27 32 36 40 43 46 50 53 55 57
Resistance to Flow
Pressure drop through mask @ 50 l/min 0.1 cmH
Pressure drop through mask @ 100 l/min 0.5 cmH
Mask Dead Space
16cc
Operating Conditions
Operating pressure range is 3-25 cm H
Operating temperature range is 40-120°F (5-50°C)
Valve activation/deactivation pressure is 2 cm H
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O
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O
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is expelled from the mask.
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185043569 Rev H
Multi-Patient Cleaning Instructions
Your Oracle™ Oral Mask is provided patient ready. To re-use between patients please follow the
guidelines below.
Cleaning/ Desoiling
Before cleaning, remove visible soil by disassembling and thoroughly cleaning the mask with a
small brush under running potable tap water.
FAILURE TO PROPERLY CLEAN THIS DEVICE MAY RESULT IN INADEQUATE DISINFECTION
High Level Disinfection Parameters
Thermal Disinfection
Soak parts in hot water bath for 30 minutes at 70˚C (158˚F).
or
10 minutes at 80˚C (176˚F)
OR
Cidex® OPA
Follow manufacturer instructions for high level disinfection.
Immerse for 30 minutes at 20°C (68°F).
Rinse thoroughly in potable water.
OR
Sporox® II
Follow manufacturer instructions for high level disinfection.
Immerse for 30 minutes at 20°C (68°F).
Rinse thoroughly in potable water.
SNAPFLAP™
COVER
CENTRE BODY
SILICONE SEAL
ELBOW
DIFFUSER CAP
FLEXITUBE
NON-REBREATHING VALVE
FEMALE SWIVEL
HEADGEAR
DIFFUSER
Handwash the Headgear in pure soap dissolved in
lukewarm water. Air dry out of direct sunlight.
Replace with new part.
THE ORACLE™ ORAL MASK HAS BEEN VALIDATED TO WITHSTAND 20 CYCLES OF THE ABOVE PARAMETERS.
DO NOT USE IF DAMAGED
Disclaimer: It is the user’s responsibility to qualify any deviations from the recommended methods of reprocessing.
Instructions for Use
Replace with new part.
NASAL PLUGS
Warnings
This CPAP mask should be used only with CPAP/Bi-Level systems recommended by your
physician or respiratory therapist. A mask should not be used unless the CPAP/Bi-Level
system is turned on and operating properly. The vent slots associated with the mask should
never be blocked.
Explanation of Warning: CPAP/Bi-Level systems are intended to be used with special masks
with connectors which have vents holes to allow continuous flow of air out of the mask.
When the CPAP/Bi-Level machine is turned on and functioning properly, new air from the
CPAP/Bi-Level machine flushes the exhaled air out through the attached mask exhalation
port. However, when the CPAP/Bi-Level machine is not operating, enough fresh air will not
be provided through the mask, and exhaled air may be rebreathed. Rebreathing of exhaled
air for longer than several minutes can in some circumstances lead to suffocations.
At low CPAP pressures the flow through the exhalation port may be inadequate to clear all
exhaled gas from the tubing. Some rebreathing may occur.
Do not use the mask without the Non-Rebreathing Valve in place while using nose plugs.
This valve ensures CO
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rebreathing is kept to a minimum in the event of power failure.
Do not use the mask if vomiting, feeling nauseous or with an oral or throat infection.
Discontinue using the mask if there is an allergic reaction, irritation, ulceration or
inflammation due to any part of the mask. Consult your physician if this occurs.
If re-using the Oracle™ Oral Mask between different patients, refer to the Multi Patient
Cleaning Instructions for the Oracle™ Oral Mask.
Replace the Non-Rebreathing Valve every 12 months.
Use the Oracle™ Oral Mask only with the headgear provided.
To avoid putting pressure on teeth, do not overtighten Headgear.
Do not use if patient suffers from bruxism.
Use of this device may cause tooth soreness, gingival soreness, and/or tooth movement.
If symptoms occur, a physician or dentist should be consulted before continuing use.
Cautions
Use the mask for its intended use only as directed in this booklet.
The prescribing physician should consider the dental history and oral health status of the
patient prior to prescribing the device.
If a patient has loose teeth or periodontal disease, a dentist should be consulted prior to use.
If a patient using this device develops these symptoms, a dentist should be consulted before
continuing use.
Contraindications
This mask should also not be used by anyone incapable of removing the mask unaided, in
the case of vomiting and aspiration, without continuous supervision.
Aust Patent Numbers:
746 574 / 765 265
Other Patents Pending
FOR ADDITIONAL INFORMATION CONTACT YOUR LOCAL HEALTHCARE PROVIDER
© Fisher & Paykel Healthcare Limited
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