LOEWENSTEIN medical CARA Nasal Mask Instruction Manual
- June 12, 2024
- LOEWENSTEIN medical
Table of Contents
LOEWENSTEIN medical CARA Nasal Mask
Product Information
- Product Name: CARA Nasal Mask
- The CARA Nasal Mask is a product manufactured by Technology GmbH + Co. KG. It is designed for treating sleep apnea and providing non-invasive and non-life-sustaining ventilation for patients with respiratory insufficiency. The mask serves as a connecting element between the patient and the therapy device.
Product Description:
The CARA Nasal Mask consists of the following components:
- Headgear
- Forehead support
- Elbow
- Rotating sleeve
- Mask body
- Mask cushion
Intended Use:
The CARA Nasal Mask is intended for use in the treatment of sleep apnea and
for providing ventilation to patients with respiratory insufficiency. It
should be used within the quoted
therapy pressure range. The mask should not be used during anesthesia. It is
important to monitor patients with restricted spontaneous respiration to
ensure the mask does not slip or fall off, as this can render the therapy
ineffective.
Contraindications:
The mask may not be suitable for use, or may require caution, if any of the
following symptoms are present:
- Erosions and ulcerations
- Skin allergies
- Flush of the facial skin
- Pressure marks on the face
- Claustrophobia
- Anxiety
- Deformities of the face or nasopharynx
- Intake of medication which may induce vomiting
- The necessity for immediate intubation
Side Effects:
Some potential side effects of using the CARA Nasal Mask may include nasal
congestion, dry nose, dry mouth in the morning, feeling of pressure in the
sinuses, irritated conjunctiva, skin rashes, pressure marks on the face, and
irritating noises when breathing.
Product Usage Instructions
Putting on the mask:
- Adjust the headgear straps to ensure a secure and comfortable fit.
- Position the mask cushion over the nose, ensuring a proper seal.
- Secure the forehead support in place.
Adjusting the mask:
- Ensure the mask is properly aligned with the face and there are no leaks.
- Adjust the headgear straps as needed for a snug fit without causing discomfort.
Removing the mask:
To remove the mask, gently lift it off the face while holding the headgear
straps.
Dismantling the mask:
To dismantle the mask, carefully detach the rotating sleeve, mask body, and
mask cushion from each other.
Assembling the mask:
To assemble the mask, connect the rotating sleeve, mask body, and mask
cushion together in the correct order.
Note: It is important to follow the specific instructions provided by your therapy device’s user manual for low pressure/leakage alarms and overall usage.
Operation
The following figures show you how to adjust, apply, remove, dismantle and assemble the mask:
- Putting on the mask
- Adjusting the mask
- Removing the mask
- Dismantling the mask
- Assembling the mask
Introduction
Intended use
The CARA mask is used for treating sleep apnea and for non-invasive and non-
life-sustaining ventilation of patients with respiratory insufficiency. It
serves as a connecting element between the patient and the therapy device.
Contraindications
The mask may not be used, or may be used only with particular caution, if any
of the following symptoms are present:
erosions and ulcerations, skin allergies, flush of the facial skin, pressure
marks on the face, claustrophobia, anxiety, deformities of the face or
nasopharynx, intake of medication which may induce vomiting, the necessity for
immediate intubation. Please also observe the contraindications in the
instructions for use of your therapy device.
Side effects
Nasal congestion, dry nose, dry mouth in the morning, feeling of pressure in
the sinuses, irritated conjunctiva, skin rashes, pressure marks on the face,
irritating noises when breathing.
Safety
Risk of injury from the supply of oxygen!
Oxygen can become deposited in clothing, bedlinen and hair. In conjunction
with smoking, naked flames or electrical equipment, it can cause fires and
explosions.
- Do not smoke.
- Avoid naked flames.
Risk of injury from re-inhaling CO2!
If the mask is used incorrectly, CO2 may be re-inhaled.
- Do not close off the exhalation system of the mask.
- Only put on the mask for an extended period if the therapy device is running.
- Only use the mask within the quoted therapy pressure range.
- Do not use the mask on patients who are unable to take it off themselves.
Risk of injury if the mask slips!
If the mask slips or falls off, the therapy is ineffective.
- Monitor patients with restricted spontaneous respiration.
- Activate low pressure/leakage alarms on the therapy device.
Risk of injury from anesthetic gases!
Anesthetic gas may escape through the exhalation valve and put third parties
at risk.
- Never use the mask during anesthesia.
Product description
Overview
A diagram of the individual parts can be found on the title page.
- Headgear
- Forehead support
- Elbow
- Rotating sleeve
- Mask body
- Mask cushion
Compatible devices
With many combinations of device, actual pressure in the mask will not
correspond to prescribed therapy pressure, even if the therapy device is
displaying the correct pressure. Have the combination of devices adjusted by a
physician or specialist dealer so that actual pressure in the mask corresponds
to therapy pressure.
Exhalation system
The mask has an integrated exhalation system. The forehead support and mask
body are shaped so that there is a gap between these parts. The exhaled air
can escape through this gap.
Hygiene treatment
Warning|
---|---
Risk of injury from inadequate cleaning!
Residues may congest the mask, impair the integrated exhalation system and jeopardize therapy success.
- For patients with a compromised immune system or particular background of illness, disinfect mask components daily following consultation with the physician.
Clean mask
- Dismantle mask (see Figure 4)
- Clean mask in accordance with the table below:
Action| Daily| Weekly
---|---|---
Wash mask components with warm water and a mild detergent.| X|
When washing mask parts, clean thoroughly with a cloth or a soft brush.| | X
Wash headgear by hand.| | X - Rinse all parts with clear water.
- Allow all parts to air-dry.
- Perform a visual inspection.
- If necessary: replace damaged parts.
- Re-assemble mask (see Figure 5)
Discolorations of mask components do not impair the functionality of the mask.
Change of patient
In the clinical sphere only: You must subject the mask to a hygiene treatment
in the event of a change of patient. Information on the hygiene treatment with
a change of patient can be found in a brochure avail-able on the
manufacturer’s website. We will also send you this brochure on request.
Disposal
You can dispose of all parts in domestic waste.
Troubleshooting
| Fault | Cause | Remedy |
|---|---|---|
| Pain from pressure on the face. | Mask too tight. | Loosen headgear slightly. |
| Draft in the eye. | Mask too loose. | Tighten headgear slightly. |
| Mask does not fit. | Contact your specialist dealer. | |
| Therapy pressure is not reached. | Mask not correctly adjusted. | Re-adjust mask |
(see Figure 2 ).
Mask cushion imaged.| Replace mask cushion.
Patient circuit leaking.| Check connectors, check tube properly located.
Technical specifications
| Product class to directive 93/42/EEC | IIa |
|---|---|
| Dimensions (W x H x D) Size XS Size S/M Size M/L |
- 72 mm x 112 mm x 70 mm
- 72 mm x 117 mm x 70 mm
- 72 mm x 118 mm x 70 mm
Weight Size
- XS Size
- S/M Size
- M/L
|
- 58 g
- 59 g
- 60 g
Therapy pressure range| 4 hPa – 30 hPa
Tube connection: tapered connection to EN ISO 5356-1| Ø 22 mm (male)
- Temperature range:
- Operation Storage
|
- + 5 °C to + 40 °C
- – 20 °C to + 70 °C
Flow resistance at 50 l/min at 100 l/min|
- 0.2 hPa
- 0.9 hPa
Quoted two-figure noise emission value to ISO 4871:
- Sound pressure level
- Sound power level
- Uncertainty factor
|
- 18 dB(A)
- 26 dB(A)
- 3 dB(A)
Standards applied| EN ISO 17510-2:2009
The right to make design modifications is reserved.
Pressure/flow curve
The characteristic pressure/flow curve shows the leakage flow as a function of
therapy pressure.
Materials
| Mask cushion | Silicone |
|---|---|
| Forehead support, rotating sleeve, mask body, elbow, headgear clip | PA |
(polyamide)
Headgear| Elastane, polyester, PU (polyurethane), UBL loop, cotton
No parts of the mask contain latex, PVC (polyvinyl chloride) or DEHP (diethylhexyl phthalate).
Warranty
- Löwenstein Medical gives the customer a limited manufacturer warranty on new original
- Löwenstein Medical products and any replacement part fitted by Löwenstein Medical in accordance with the warranty conditions applicable to the product in question and in accordance with the warranty periods from date of purchase as listed below. The warranty conditions are available on the website of the manufacturer. We will also send you the warranty conditions on request.
- Please bear in mind that any claim to warranty and li-ability shall be void if neither the accessories recommended in the instructions for use nor genuine replacement parts are used.
- In the event of a claim under warranty, contact your specialist dealer.
| Product | Warranty periods |
|---|---|
| Masks including accessories | 6 months |
Declaration of conformity
The manufacturer Löwenstein Medical Technology GmbH + Co. KG (Kronsaalsweg 40,
22525 Hamburg, Germany) hereby declares that the product complies with the
relevant regulations of Directive 93/42/EEC governing medical devices. The un-
abridged text of the Declaration of Conformity can be found on the
manufacturer’s website.
Löwenstein Medical Technology GmbH + Co. KG Kronsaalsweg 40
22525 Hamburg, Germany T : +49 40 54702-0
F : +49 40 54702-461
www.loewensteinmedical.de