Caremaxx 60500 - Medical device TREBS - Free user manual and instructions

USER MANUAL Caremaxx 60500 TREBS

GB Unit and controls

1. Unit
2. Battery compartment
3. Warning lamp
4. ON-button
5. Cable connector for nasal applicator
6. Cable
7. Applicator base
8. Nasal applicator

2 Interesting facts about allergies

Allergies – Why are they becoming more frequent? 21

Hay fever – A trifling complaint?

Hay fever – How it arises.

What can help to combat this over-reaction?

How phototherapy using the Bionase can help you.

The benefits of your phototherapy with Bionase.

3 Starting up

Packaging / Scope of supply 22

Activation / replacing the battery

4 Phototherapy with Bionase

Use of the Bionase appliance 23

Duration and frequency of application

Preventive treatment

Phototherapy – safe and effective

5 General

Cleaning and care 24

Notes on disposal

Technical data

6 Warranty 26

Warranty and repair conditions

Technical data 27

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Introduction

Thank you for your confidence.

Valued customer,

Congratulations on purchasing the Bionase. You have bough a quality product from Caremaxx. Treatment with your Bionase appliance is very easy and can be carried out almost anywhere. The applications lasting only approx. 4 minutes can provide you with a significant improvement within the shortest of times, Please read carefully through the appliance's instructions for use and follow the safety instructions to ensure safe operation and the best possible effect before using it for the first time. Keep these instructions for use in a safe place and include them if the appliance is passed on to a third party.

Thanks you for purchasing the Bionase. We wish you every success with it.

The Bionase appliance from Caremaxx carries the CE symbol (conformity symbol) confirming the appliance's conformity to "Guideline 93/42/EEC of the Council dated 14 June 1993 governing medicinal products". The corresponding conformity declaration is available at Caremaxx's premises.

Bionase is imported into EC by: (authorized EU representative in accordance with the MPG)

Trebs BV, 6467JE, Kerkrade, The Netherlands

Sales are made through: Caremaxx NV, 6467JE, Kerkrade, The Netherlands

We reserve the right to make technical modifications for the improvement and further development of the product.

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Safety notes

• The appliance is licensed for home therapy and must not be used for commercial purposes. It cannot take the place of a visit to the doctor.
  • Children may only use the appliance under adult supervision.
• Keep the battery out of the reach of children. The battery is not rechargeable. Do not short-circuit the battery or throw it into a fire.
• Hand it in to your dealer or a local collection point for recycling.
• Only use the appliance for the purpose defined in the instructions for use. The right to claim under the warranty will expire in the event of misuse.
• Only use the nasal applicators from Caremaxx.
• Do not under any circumstances attempt to repair the appliance yourself. Contact your specialist dealer.
• Applications with the Bionase are generally perceived as pleasant. Cut short the application immediately if you experience sudden pain or the application becomes unpleasant and consult your doctor.
• The appliance will have limited or no effectiveness in the case of chronic inflammations of the nasal mucosa, deformations of the nasal septum or polyps.

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2 Interesting facts about allergies

Allergies – Why are they becoming more frequent?

Illnesses caused by allergies such as hay fever and allergic reaction to house dust an animal hair have almost doubled in the last few years. It is not yet medically clear why more and more people are suffering from allergic symptoms. Exaggerated hygiene in childhood may hamper the development of the immune system and favour allergies. It is certain, however, that along with heredity increased environmental pollution plays a significant role in the development of allergies.

Hay fever – A trifling complaint?

Hay fever, otherwise known as allergic rhinitis, is not actually a fever and does not necessarily have anything to do with hay. It is not caused by a virus but by pollen. Hay fever should always be taken seriously. The allergy can spread to the lower respiratory passages, leading to chronic disorders and finally to asthma. Your doctor can provide you with a diagnosis and the correct individual advise for you.

Hay fever – How it arises.

It is our immune system's job to fend off and render harmless any contaminants that invade our bodies. In the case of an allergy, the immune system over-reacts to these contaminants. Even the tiniest amounts of allergens, such as flower pollen for example, are enough to include the typical hay fever symptoms:

• Agonising desire to sneeze combined with violent sneezing attacks;
  • Swollen, itchy nasal mucosa;
• Itchy, watery, swollen eyes.

The reason for this is an over-reaction of our defence mechanism. As soon as the flower touches the mucous membranes of the nose and eyes, the body mobilises all its defences. Too many antibodies are created. These sit on the so-called mast cells.

The mast cells in turn release tissue substances (primarily histamine) that lead to the typical miseries of hay fever.

What can help to combat this over-reaction?

Of course, the easiest way of preventing an allergy is to consistently avoid all substances that trigger allergies. However, in practice this is hardly possible as one can come across allergens not only outside but also at home (due to house dust) or in foodstuffs.

In addition to drug treatment using antihistamines and cortisone, inoculations and acupuncture, specialist centres successfully use cost-intensive phototherapy. In this case red light rays of one wavelength (approx. 660nm) are generated by special light emitting diodes to eliminate the allergic symptoms and the over-sensitivity.

How phototherapy using the Bionase can help you.

Phototherapy is a new type of allergy treatment without drugs.

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Now with your Bionase from Caremaxx you can quite easily carry out yourself what until recently was only available as a very cost-intensive therapy in special centres. Diodes that are able to emit red light of exactly the right wavelength (approx. 660nm) have been developed for the Bionase. Alleviation of allergic symptoms and lessening of the over-sensitivity of the nasal mucosa sets in at this wavelength.

The benefits of your phototherapy with Bionase:

• Phototherapy is a drug-free treatment.
- The highly effective application lasting only approx. 4 minutes can be carried out practically anywhere.
- The treatment has no effect on other organs or body parts due to its use locally.

The typical symptoms of hay fever were significantly reduced in a clinical test using the Bionase. Some symptoms were alleviated or even eliminated completely in a matter of only a few hours. In the majority of patients it was possible to identify a clear improvement in the condition within two weeks.

3 Starting up

Packaging / scope of supply

We would like our high-quality medical products to reach you in the same condition as they left us. For this reason your Bionase is packed in a sturdy protective package made from environmentally compatible materials. If you do not want to use the box for storing the appliance, it may be

sent for recycling with your waste paper. Please dispose of the plastic films at the local waste site. The package contains the following parts:

• 1 Bionase appliance
• 1 Battery (monobloc 9 Volt, 6LR61)
• 1 Nasal applicator
• 1 Instructions for use

Please consult your dealer if you discover that the appliance is damaged or fails to function as expected after unpacking.

Activation / replacing the battery

Important: The 9V monobloc battery is already inserted on delivery of the appliance. The contacts are protected with an insulating strip to prevent the battery from discharging. This insulating strip must be removed prior to starting the appliance up for the first time. Press down on the symbol on the battery compartment lid (back of the appliance) and at the same time slide it in the direction of the arrow. Now pull out the insulating strip by the tab. Then replace the battery compartment lid and slide it upwards until it clicks audibly into place. After approx. 100 applications, the green pilot LED will flash after pressing the ON button if the battery power is insufficient for another application. Open the battery compartment (as describes above), remove the spent battery and insert a new 9 volt monobloc battery 6LR61 (in the position shown inside the battery compartment). Close the battery compartment again.

Caution! Batteries may not be disposed of with your domestic waste under any

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circumstances. Hand them in to your dealer or to your local collection point for recycling.

4 Phototherapy with Bionase

Use of the Bionase appliance

• Insert the plug on the cable of the nasal applicator into the socket of your Bionase appliance.
• The nasal applicator must be spread slightly apart to allow the LEDs to be inserted in the nostrils. Insert the LEDs as far as possible into the nostrils. The nasal applicator should nevertheless sit comfortably.
• Press the ON button to start the treatment and begin light emission. The green pilot LED on the front of your Bionase will be lit constantly during use.
• Light emission will be ended automatically after approx. 4½ minutes. The green pilot LED will go out thus indicating that the application has ended.
• Now remove the applicator from nostrils.

Notes:

• If the green pilot LED flashes that indicates that the cable is not plugged in correctly or that there is insufficient voltage in the battery for an application.
• If the green pilot LED neither I up nor flashes this indicates that the battery has been incorrectly inserted or is completely discharged.

Duration and frequency of application

• An application with the Bionase appliance only lasts approx. 4 minutes. During this time, the LEDs radiate red light having a wavelength of approx. 660nm and a defined intensity. The automatic shut-off ensures that the duration of treatment always remains the same and prevents the nasal mucosa from being overloaded.
  • The Bionase should be used three times a day at the beginning of treatment.

- Treatment should be spread over the course of a day. The first application should be carried out either before or after breakfast and the last in the evening before going to bed whilst the third application can be carried out during the day simply by taking the appliance with you and using it when the opportunity arises.

Note:

The application should be continued for at least one week and preferable two to achieve the desired treatment result.

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Preventive treatment

Your Bionase appliance may be used not only in the acute phase of the illness but also as a preventive measure. You will most likely know the period during which your allergy starts or the type of pollen that causes it. Find out about the current pollen count situation, e.g. on the internet. This way you can gain experience of when the different types of pollen are likely to be most active in your area and take preventive measures in good time.

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Begin prophylactic treatment a good week before the pollen that triggers your allergy is forecasted. Even at this stage you should carry out an application three times a day depending on the severity of your allergy.

Phototherapy – safe and effective The red light used for phototherapy with Bionase has no negative effects on the nasal mucosa. Even with therapy continued over a longish period, there is no fear of any structural impairment of the tissue when no more than three applications per day are administered. If your doctor suggests medical treatment due to the severity of your allergy, it may be combined with phototherapy without hesitation. There are no known interactions with anti-allergenic drugs such as antihistamines or corticosteroids.

5 General

Cleaning and care

• Clean both LEDs after each use with a damp cloth and a mild soap.
• Do not use aggressive detergents stiff brushes under any circumstances.
• Do not immerse either the applia or the cable with the LEDs in water. If liquid has managed to get into the appliance, remove the battery immediately and contact your specialist dealer.
• The nasal applicator may be disinfected with an alcoholic disinfectant, e.g. 70% ethanol.
• You may purchase additional nasal applicators from your specialist dealer

so that your Bionase appliance can be used by several people under hygienic conditions.

• Remove the battery from the appliance if you do not intend to use it for a longish period. This will prevent the battery from leaking.
• No further maintenance or checking is necessary if the appliance is used in accordance with these instructions for use.

Notes on disposal

This product must not be disposed together with the domestic waste.

All users are obliged to hand in all electrical or electronic devices, regardless of whether

or not they contain toxic substances, at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner.

Please remove the battery before disposing of the equipment. Do not dispose of old batteries with your household waste, but dispose of them at a battery collection station at a recycling site or in a shop. Consult your municipal authority or your dealer for information about disposal.

6 Warranty

Warranty and repair conditions

Please contact your dealer or the service centre in case of a claim under the warranty. If you have to send in the unit, please enclose a copy of your receipt and state what the defect is.

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The following warranty terms apply;

• The warranty period for Caremaxx products is three years from the date of purchase. In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.

- Defects in material or workmanship will be removed free of charge within the warranty period.

- Repairs under warranty do not extend the warranty period either for the unit or for the replacement parts.

- The following is excluded under the warranty:

a. All damage which has arisen due to improper treatment, e.g. non-observance of the user instructions.
b. All damage which is due to repairs or tampering by the customer or unauthorized third parties.
c. Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre.
d. Accessories which are subject to normal wear and tear.

5 Liability for direct or indirect consequential losses caused by the unit are excluded even if the damage to the unit is accepted as a warranty claim.

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Technical data
Model: Bionase
Application: Phototherapy for allergic reactions of the nasal mucosa
Duration of the application:	41⁄2 minutes +/- 10%
Frequency of application:	Maximum 3 applications per day
Light emission:
Storage condition:	-20°C to +50°C, maximum 85% relative humidity, non-condensing
Operating conditions:	+10°C to +40°C, maximum 70% relative humidity, non-condensing
Dimensions:	approx. 90x65x30mm
Weight:	approx. 120g including battery
Battery:	9 Volt type 6LR61
Service life of battery:	approx. 100 applications
Appliance classification:	BF
Article No:	60500
EAN Code :	87 17964 60500 5

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Caremaxx NV

Euregiopark 18

NL-6467JE, Kerkrade

The Netherlands

Tel.: +31 (0)45 - 5 280 389

Fax: +31 (0)45 - 5 233 518

E-mail: [e-mail]

www.caremaxx.nl

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Caremaxx®

Inhalt

1 Einführung