Respironics Image 3 SE Gebrauchsanleitung

Instructions for Use
Intended Use - The Image 3 SE Disposable Full Face Mask is intended to provide a patient interface
for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that
have adequate alarms and safety systems for ventilator failure, and which are intended to administer
CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency,
or obstructive sleep apnea.
The mask is disposable and for single patient use. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation, in the
hospital/institutional environment only.
Warnings
• This mask does not include an anti-asphyxia valve that would allow a patient to
breathe if the ventilator failed.
• In the event of ventilator failure, use of this mask requires the same level of
attention and assistance as the use of a tracheal tube.
• This mask must be used with ventilators which have adequate alarms and safety
systems for ventilator failure.
• This mask should not be used on patients who are uncooperative, obtunded,
unresponsive, or unable to remove the mask.
Notes
• Verify that the mask and headgear are the correct size.
• Dispose of this mask in accordance with local regulations.
Contraindications
This mask is contraindicated for patients without a spontaneous respiratory drive. This mask may not be suitable for persons 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 uncooperative, obtunded, unresponsive, or unable to remove the mask.
Before Each Use
• Verify that the therapy device, i.e., ventilator, including the alarms and safety systems, has been validated prior to use.
• Check for the blue elbow on the mask, and note that the mask does not include an anti-asphyxia valve that would allow a patient to breathe if the ventilator failed.
• With the headgear disconnected, wash the mask cushion and inner mask shell in warm water with a mild dishwashing detergent. Do not use bleach, alcohol, cleaning solutions
containing alcohol, or any strong household cleaners. Do not use cleaners containing conditioners or moisturizers. Rinse
thoroughly. Air dry. Note: Do not attempt to clean the headstrap. Replace the headstrap if it becomes soiled.
• Inspect the mask and replace it if the cushion has hardened or is torn, or if any parts are broken.
• Wash the patient's face.
• Verify therapy device pressure(s).
Using the Mask
Step 1.
Hold the mask lightly against the patient's face and slide the headgear over their head. You may want to
disconnect one of the swivel clips before putting the headstrap on the patient. Reconnect the swivel clip after the
headstrap is in position.
Step 2.
Connect the patient circuit to the 22mm blue elbow.
Step 3.
Turn on the noninvasive ventilator. Instruct the patient to breathe normally.
®
Step 4.
Unfasten the Velcro tabs on the headstrap and gradually tighten to ensure the mask is tight enough to achieve
minimal mask cushion leak and a comfortable fit.
Step 5.
Adjust the headstrap until the mask has minimal cushion leaks and fits comfortably. Adjust the upper side straps
first, making sure that they are above the ears. Adjust the lower side straps, making sure the headgear securely fits
the back of the head. Re-adjust the strap tension if leaks occur as the patient's position changes. DO NOT
overtighten the straps. Overtightening can cause or worsen leaks.
Removing the Mask
To quickly remove the mask, remove the swivel clip ball from the mask socket to release the headgear.
Reconnecting the Headgear and Mask
Step 1.
Slide the headgear swivel clips into the faceplate until they lock.
Step 2.
Insert the two lower side straps through the appropriate swivel clip. Fold back and press the hook tab on each strap until the strap is
secure.
Step 3 .
Insert the middle strap (from the top of the headgear) through the slot on the top of the mask faceplate. Fold back and press the hook
tab until the strap is secure.
Step 4 .
Position the upper side straps so they are comfortably above the ears, and tighten as necessary.
Step 5 .
To shorten the top strap, overlap the strap and position the hook tab to a convenient length.
Covered by one or more of the following patents:
English
Des 464,727 and 475,453. Other patents pending.
SE
(Standard Elbow)
1009591 Small with Headgear (each)
1009593 Medium with Headgear (each)
1010879 Large with Headgear (each)
452040 NG Tube Sealing Pad (10/pack)
1004877 Disposable 3 Strap Headgear
SINGLE PATIENT USE
ONLY
LATEX-FREE
• Contact the physician if the patient experiences unusual chest discomfort, shortness
of breath, stomach distention, belching, or severe headache when he awakens or when
he is receiving positive airway pressure.
• If the patient experiences skin irritation, consult the physician.
• To minimize the risk of vomiting during sleep, the patient should avoid eating or
drinking for three hours before using the mask. This mask is not recommended if the
patient is taking a prescription drug that may cause vomiting.
• If the patient has respiratory insufficiency or respiratory failure, he/she should wear
this mask ONLY when therapy is being delivered.
• If a nasogastric (NG) tube or similar device is in place, use the optional NG tube
sealing pad. Position the pad so that its flat surface is against the patient's face and the
C-shaped opening surrounds the tube.
Reorder Numbers
1018575 Small with Headgear (10/pack)
1018576 Medium with Headgear (10/pack)
1018577 Large with Headgear (10/pack)
1009723 Headgear Swivel Clips, 2 pack
www.respironics.com
The deadspace associated with this mask
is between 210 cc and 335 cc.
The maximum unintended leak from parts
of the mask and its connectors is 9.4 LPM
at 20 cm H 2 0 and 12.6 LPM 35 cm H 2 O.
1014530
HM 12/4/03