LOWENSTEIN medical WM 68325b Nasal Mask Instruction Manual
- June 1, 2024
- LOWENSTEIN medical
Table of Contents
LOWENSTEIN medical WM 68325b Nasal Mask Instruction Manual
with the warranty periods from date of purchase listed below. The warranty
conditions are available on the manufacturer’s website. We will also send you
the warranty conditions on request.
Please bear in mind that any claim under warranty and liability shall be void
if neither the accessories recommended in the instructions for use nor genuine
spare parts are used.
In the event of a claim under warranty, contact your specialist dealer.
12 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 provisions of the Medical Device Regulations (EU) 2017/745. The
unabridged text of the Declaration of Conformity can be found on the
manufacturer’s website.
In the EU: As a user and/or patient, you must report any serious incidents occurring in conjunction with the product to the manufacturer and to the responsible authority.
1 Operation
The figures show the following steps for operating the mask:
- Putting on the mask
- Adjusting the mask
- Removing the mask
- Dismantling the mask
- Assembling the mask
For blind and partially-sighted users An electronic version of the instructions for use is also available on the manufacturer’s website.
2 Introduction
2.1 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 link between the patient and the ventilator.
2.2 Contraindications
The mask must not be used on patients weighing < 30 kg. The mask must not be used in the following situations: Immediate intubation required, loss of consciousness, acute vomiting. The mask may be used in the following situations only with particular caution: Pressure points and acute injuries to the skin of the face; skin allergies involving the face; deformities of the face or nasopharynx; acute pain affecting the face; cough reflex restricted or absent; claustrophobia; acute nausea. If you are not sure whether one of these situations applies to you, consult your healthcare professional. Observe the contraindications in the instructions for use of your device.
2.3 Side effects
The following side effects may occur with use of the mask: 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.
If these side effects occur, contact your healthcare professional.
2.4 Clinical benefit
Transfers the therapeutic efficacy of the ventilator to the patient
3 Safety
Risk of injury due to damaged mask parts or those under strain!
⇒ Perform a visual inspection before every use and after every cleaning
operation.
⇒ Note useful life (see section entitled “Technical Data”).
⇒ Replace mask parts if necessary.
Risk of injury due to the use of oxygen!
Oxygen can become deposited in clothing, bedlinen, and hair. Supplying oxygen
without a safety device can lead to fire. ⇒ Use an oxygen safety valve.
⇒ Follow the instructions for use for the oxygen supply system.
⇒ Set up oxygen sources at a distance > 1 m from the device.
⇒ Do not smoke.
⇒ Avoid naked flames.
⇒ Ventilate the room well.
⇒ Keep mask free from oil and grease.
Risk of injury due to patient receiving inadequate supply!
⇒ Activate low pressure/leakage alarms on the ventilator.
⇒ Use the appropriate mask size and check that it is securely in position.
⇒ Monitor patients with restricted spontaneous breathing.
Risk of injury from re-inhalation of CO2!
⇒ Only use the mask when therapy is in progress. ⇒ Only use the mask within
the quoted therapy pressure range.
⇒ Patients unable to remove the mask themselves must be monitored by a nurse.
⇒ Do not close off exhalation systems.
Risk of injury due to escape of anesthetic gas or atomization of drugs!
⇒ Do not use the mask during anesthesia.
⇒ Do not use the mask to atomize drugs.
Risk of injury from inadequate cleaning!
⇒ Clean mask parts before using for the first time
(see section entitled “Cleaning and reprocessing”).
⇒ Clean the mask regularly. ⇒ When selecting a detergent, consider potential
allergies.
⇒ On change of patient in a hospital environment: Comply with the document
entitled Information on reprocessing (see section entitled “Reprocessing”).
⇒ For patients with a compromised immune system or particular background of
illness, disinfect mask parts daily following consultation with the healthcare
professional.
4 Product description
A diagram of the individual parts can be found on the title page.
Compatible devices
In some device combinations, actual pressure does not correspond to the
therapy pressure displayed by the device. Have the device adjusted by a
healthcare professional so that actual pressure in the mask corresponds to
therapy pressure. This setting should be made using the type of mask used
during therapy.
Exhalation system
The mask has an integrated exhalation system. The exhaled air escapes through
a gap.
5 Cleaning and reprocessing
5.1 Clean mask
-
Wash your hands before starting cleaning.
-
Dismantle mask (see Figure 4 ).
-
Wash mask by hand (max. 30 °C, 1 ml mild deter-gent in 1 l water) in accordance with the table below:
All parts can be washed in a dishwasher once a week (max. 70 °C, mild detergent, max. program length 90 minutes, top basket, separate rinse). -
Rinse all parts with clean water.
-
Allow all parts to air-dry.
-
Perform a visual inspection for cracks and deformation. Replace damaged parts. Discoloration is not a problem.
-
Assemble mask (see Figure 5 ).
5.2 Reprocessing (clinical environment)
In the event of a change of patient, follow the instructions in the document entitled Information on reprocessing. The document can be found on the manufacturer’s website. We will send you the document on request.
5.3 Disposal
Dispose of the mask in domestic waste. In the clinical environment: Dispose of the mask in accordance with hospital regulations.
6 Troubleshooting
7 Technical data
8 Materials
No parts of the mask contain latex, PVC (polyvinyl chloride) or DEHP (diethylhexyl phthalate). In the event of allergies to the materials listed, only use the mask following agreement with the healthcare professional.
9 Characteristic pressure/flow curve
10 Markings and symbols
The following markings and symbols may be applied to the device, accessories or packaging.
11 Warranty
Löwenstein Medical Technology gives the purchaser of a new original Löwenstein Medical Technology product and of a spare part fitted by Löwenstein Medical Technology a limited manufacturer warranty in accordance with the warranty conditions applicable to the product in question and in accordance
Manufacturer
Löwenstein Medical
Technology GmbH + Co.KG
Kronsaalweg 40
22525 Hamburg, Germany
T: +49 40 54702-0
F: +49 40 54702-461
www.loewensteinmedical.com
References
Read User Manual Online (PDF format)
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