LOEWENSTEIN medical CARA Full Face Mask User Manual

LOEWENSTEIN medical CARA Full Face Mask User Manual

Operation

The following figures show you how to adjust, apply, remove, dismantle and assemble the mask:

1. Putting on the mask
2. Adjusting the mask
3. Removing the mask
4. Dismantling the mask
5. Assembling the mask

Assembly Instruction

Introduction

Intended use

The CARA Full Face 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 in the following situations: necessity for immediate intubation; 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 facial skin; 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 certain whether one of these situations applies to you, please consult your attending physician or medical advisor. Please also observe the contraindications in the instructions for use of your therapy device.

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. Should such side effects occur, please contact your attending physician or medical advisor.

Safety

Safety information

Risk of injury from mask parts breaking off!
Deteriorated mask parts or those under severe strain may come off and put the patient at risk.

• Note useful life.

• Check mask parts regularly and replace prematurely if necessary.
  Risk of injury from excessive leaking!
  Excessive leaking can lead to under-supply to the patient.

• Activate low pressure/leak alarms on the therapy device.

• Use the correct mask size and check that it is securely in position.
  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.

• Patients who are unable to take the mask off themselves must be monitored by qualified nursing staff.
  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.
  Risk of injury from lack of cleaning!
  The mask may show contamination, which can possibly put the patient at risk.

• Clean the mask before using for the first time (see section entitled “Cleaning and hygiene treatment”).

• Clean the mask regularly.

General information

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.

Product description

Overview

A diagram of the individual parts can be found on the title page.

1. Headgear
2. Link
3. Elbow
4. Anti-asphyxia valve
5. Rotating sleeve
6. Mask body
7. Headgear clip
8. Mask cushion

Compatible devices

The therapy pressure required may vary between different mask types, so prescription of a suitable therapy pressure should in each case involve adjusting/ adapting therapy to suit the mask type which is also  going to be used during therapy itself.

Exhalation system

The mask has an integrated exhalation system. The link and mask body are shaped so that there is a gap between these parts. The exhaled air can escape through this gap.

Anti-asphyxia valve

WARNING

Risk of asphyxia if anti-asphyxia valve not working properly!

Residues may cause the valve to stick and lead to CO2 being re-inhaled.

• Check before every use that the openings of the anti-asphyxia valve are clear

If the therapy device fails, the anti-asphyxia valve opens so that the patient can breathe ambient air.

Cleaning and 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

1. Dismantle mask (see Figure 4 ).
   

2. 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.0r: Put the mask parts in the dishwasher.| | X
   Wash headgear by hand.| | X

3. Rinse all parts with clear water.

4. Allow all parts to air-dry.

5. Perform a visual inspection.

6. If necessary: replace damaged parts.

7. Re-assemble mask (see Figure 7 ).
   

Discolorations of mask components do not impair the functionality of the mask.

Hygiene treatment (clinical sphere)

On change of patient, inadequate hygiene treatment may lead to a risk of infection for the patient. In the event of a change of patient, subject the mask to a hygiene treatment in line with the Information on hygiene treatment brochure. The brochure can be found on the manufacturers website. We will send you this brochure on request.

Disposal

You can dispose of all parts in domestic waste.

Troubleshooting

slightly.
** Draft in the eye.| Mask too loose.| Tighten headgear slightly.
Mask does not fit.| Contact your specialist dealer.
Fault| Cause| Remedy**
---|---|---

Therapy pres- sure is not reached.

| Mask not correctly adjusted.| Re-adjust mask (see Figure 2).


Mask cushion damaged.| Replace mask cushion.
Patient circuit leaking.| Check connectors, check tubes properly located.
Anti-asphyxia valve defective (only vented).| Replace the mask.

Technical specifications

93 mm x 145 mm x 89 mm95 mm x 160 mm x 90 mm95 mm x 174 mm x 91 mm

Weight Size S Size M Size L| 93 g97 g102 g
Dead space Size SSize M Size L| 180 ml219 ml244 ml
Therapy pressure range| 4 hPa – 25 hPa
Tube connection: tapered connection toEN IS0 5356-1vented|

Ø 22 mm (male)

Temperature range: 0perationTransport and storage| +5 °C to + 40 °C-20 °C to +70 °C
---|---
Flow resistance at 50 l/minat 100 l/min| 0.15 hPa0.5 hPa
Flow resistance, anti- asphyxia valve Inspiration at 50 l/min: Exhalation at 50 l/min:| **** 0.6 hPa0.8 hPa
Switching pressure Anti-asphyxia valve• 0pen:• Close:| **** 0.5 hPa2.2 hPa
quoted two-figure noise emission value toIS0 4871:-  Sound pressure level- Sound power level-  Uncertainty factor| **** 19 dB(A)27 dB(A)3 dB(A)
Service life| 5 years
Useful life| up to 12 months 1
Standards applied| EN IS0 17510:2020

The mask materials deteriorate if exposed to e.g. aggressive detergents. In individual cases it may be necessary to replace mask parts sooner.

Pressure/flow curve

The characteristic pressure/flow curve shows the leakage flow as a function of therapy pressure.

Materials

Only use the mask after consulting your physician if you are allergic to any of the following substances:

PA (polyamide), SI (silicone),PP (polypropylene)

No parts of the mask contain latex, PVC (polyvinyl chloride) or DEHP (diethylhexyl phthalate).

Markings and symbols

The following symbols may be applied to the device, the device label, accessories or packaging.

directives/regulations)

Warranty

Lowenstein Medical Technology gives the customer a limited manufacturer warranty on new original Lowenstein Medical Technology products and any replacement part fitted by Lowenstein Medical Technology 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 liability 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.

Declaration of conformity

The manufacturer Lowenstein Medical 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.

References

• Menschen im Mittelpunkt | Löwenstein

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