Section 312g (2) No. 3 of the German Civil Code (BGB)

§ 312g Paragraph 2 No. 3 BGB – Exclusion of the Right of Withdrawal for Hygiene Products


Legal Basis: When Does the Right of Withdrawal Not Apply?


According to § 312g Paragraph 2 No. 3 BGB, there is no right of withdrawal for certain products:


“Contracts for the supply of sealed goods which are not suitable for return due to health protection or hygiene reasons, if their seal was removed after delivery.”“

(Source: BGB § 312g)


This also applies if a seal in the form of special packaging or wrapping is not explicitly labeled as a “hygiene seal,” but is already provided by the closed product packaging ist.Bitte please note that the seal in a broader sense is not limited to a specific seal or tag, but can also be provided by an intact original packaging from the manufacturer.

This regulation serves to protect consumers and ensures that products, which cannot be resold for hygienic or health reasons, may not be returned.


What does "sealing" mean in a legal sense?


The jurisprudence confirms that a seal does not only have to be an additional protective film but also includes tamper-proof packaging that clearly defines the first use. It is crucial that the product can no longer be resold hygienically safely after opening.


Which packaging meets this requirement?


1. The original packaging of the product


✔ Many of our products are delivered in a sealed package that clearly defines the first use.

✔ This packaging not only protects the product itself but also its hygienic condition.

✔ The opening of the packaging is therefore considered as removing the seal and excludes the right of withdrawal.


2. Disposable packaging of hygiene accessories


✔ Masks, tubes, and other hygiene items are delivered in sealed individual packaging.

✔ These protective packages prevent contamination and guarantee the hygienic condition of the goods.

✔ If the seal is removed or the packaging is opened, the product cannot be returned for hygiene reasons.



 

Why is the right of withdrawal excluded?


Many of our products come into direct contact with the skin, respiratory air, or body fluids. After opening the packaging:


🔹 Hygienic safety can no longer be guaranteed.

🔹 Proper disinfection is not possible.

🔹 The product falls under the legal exclusion of the right of withdrawal.


➡ Therefore, the return of an opened product is not permitted.


Additional legal bases confirming the exclusion of the right of withdrawal


1. Recital 47 of the EU Consumer Rights Directive (2011/83/EU)


The German regulation is based on the EU Consumer Rights Directive:


“The right of withdrawal should not apply to goods which are not suitable for return due to health protection or hygiene reasons and were unsealed after delivery.”


Core argument:

An opened or used hygiene product cannot be resold hygienically and therefore falls under this regulation.


2.Case Law on "Sealing"


The European Court of Justice (ECJ) and German courts have confirmed that the original packaging is considered protective packaging:


📌 ECJ Judgment C-681/17 (FlixBus Voucher)

🔹 Sealing does not necessarily have to be an additional film.

🔹 The crucial factor is whether the product can no longer be safely used once opened.


📌 Hamburg Regional Court, Judgment of 13.10.2016 – 327 O 90/16

🔹 The return of hygiene products is excluded if they have been opened once.

🔹 Reprocessing or disinfection is not possible.


📌 Dieburg District Court, Judgment of 25.07.2019 – 20 C 484/19

🔹 Products that can come into contact with body fluids are considered sealed even without additional protective film.


Core argument:

A hygiene product that can no longer be safely used after opening is subject to the statutory exclusion of the right of withdrawal.

 


 

Conclusion


The withdrawal is excluded according to § 312g paragraph 2 no. 3 BGB.

The EU directive confirms the protection of hygiene products.

Court rulings demonstrate that the original packaging is also considered a seal.


❌ The return of an opened medical or hygienic product is excluded for health reasons.


These legal foundations serve not only to provide clarity for consumers but also to protect the health of all customers.

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Settings and Functions

Where can you have the device adjusted if you order it online?

You can use the settings of your usual CPAP therapy on the DreamStation or Dream Station Go. The steps are clearly explained in the user manual.

Is it allowed to adjust the device yourself?

The device can be adjusted by you at any time. The individual operating steps can be found in the user manual. For further assistance, we recommend contacting your sleep lab or doctor.

What is the Flex Degree Setting?

With this, you can adjust the level of air pressure relief you feel during therapy when exhaling. This feature can be activated or deactivated by your specialist dealer. If your specialist dealer activates the "Flex" feature, they will already set a specific level for you on the device. You can increase or decrease this setting to a value between 1 and 3. The setting "1" represents a low pressure relief, while higher numbers indicate greater pressure relief.

What is the ramp function?

For a more comfortable adjustment to the inspiratory pressure of your sleep therapy, you can ask your specialist dealer to set a ramp. This means you determine a low initial pressure setting and a time period during which the device increases the pressure from the ramp start pressure to the therapy pressure setting over the specified duration.

Devices

What is sleep apnea?

Sleep apnea is a common sleep disorder characterized by repeated breathing interruptions during sleep.

 

These interruptions, also called apneas, are caused by the collapse of the upper airway, preventing oxygen from reaching the lungs.

 

Apneas can significantly affect your energy levels, mental performance, and long-term health. Therefore, do not ignore potentially dangerous symptoms such as snoring and excessive daytime sleepiness, but consult a sleep specialist. Treatment can help you get the sleep you need to feel like yourself every day.

Which sleep mask is right for you?

Overview of Sleep Masks

Your mask has a significant impact on the effectiveness of your therapy. It should meet your personal needs and not cause leaks or pressure points on your face. Also, talk to your doctor about your personal habits and needs to find out which model is suitable for you.

We offer you masks from the DreamWear series, which, with their innovative design, allow a high degree of freedom of movement and are available in the Philips online shop. Additionally, you can obtain these and other Philips sleep therapy masks from a specialist retailer of your choice.

Cpap bipap difference?

Even though CPAP and BiPAP are identical in application through the mask, functionality, and opening effect, the two ventilation methods also differ in some aspects.

The most decisive difference is the air pressure. CPAP has only one air pressure setting, whereas BiPAP has two. This means a CPAP device exerts a constant pressure on the airways, while a BiPAP mask provides higher pressure during inhalation and lower pressure during exhalation. As a result, CPAP users need to exert more effort when exhaling compared to BiPAP users.

What is positional sleep apnea?

In classic sleep apnea, the airways are repeatedly blocked during sleep, leading to interruptions in breathing. Positional sleep apnea is a special form of this condition. Here, the airways are primarily blocked when lying on the back.

Sleep apnea affects sleep quality and can significantly impact performance and overall health. If you have sleep apnea and apnea events occur twice as often when lying on your back compared to lying on your side, your sleep apnea is likely positional. Sleeping on your side can significantly reduce your symptoms.

BiPAP or CPAP?

BiPAP (biphasic positive airway pressure) is a form of ventilation that combines a ventilator with spontaneous breathing. The patient can breathe spontaneously through BiPAP ventilation without interrupting the preset ventilation rate.

This is a form of ventilation in intensive care that allows for pressure-supported breathing.

It is used when the patient needs to be ventilated but should still train their own spontaneous breathing. In obstructive lung diseases such as COPD or asthma, BiPAP ventilation can only be performed with special control, as there is a risk of under- or over-supply of breathing volume.

CPAP Therapy: Assistance for Obstructive Sleep Apnea

In CPAP therapy, it is a breathing therapy that takes place during sleep.It is considered the standard therapy and is the most commonly used method for obstructive sleep apnea (OSA)

Masks

Why oxygen mask?

An oxygen mask is a device that covers the face or nose and mouth,to enable the inhalation of pure oxygen or a breathing gas mixture under difficult conditions. These include reduced atmospheric pressure, contaminated environment, or hypoxia.

When to replace CPAP masks?

Why and how often should I obtain a new CPAP mask cushion?

If any part of the system shows signs of wear (cracking, splitting, discoloration, cushion damage, etc.), you should dispose of and replace the affected component.

If you wear a face mask and notice that the valve is damaged, warped, or torn, you should replace the elbow. The mask should no longer be worn if the valve is damaged, as it can no longer fulfill its safety function.

Since the schedule for replacing the mask is tailored specifically to you, we highly recommend reading the detailed information in the user manual for your mask.

In general, the following signs indicate that the mask or one of its components should be replaced:

You need to constantly readjust the headbands,The mask no longer feels soft and springy but stiff,You feel that the treatment is not as effective as before,The mask cushion is slippery even after cleaning,The mask cushion is no longer clear and transparent,The mask cushion and frame show signs of wear, stiffness, cracks, or breaks.