What is the FeelSafe Pro?

The FeelSafe Pro is a tent bed system consisting of a tent, a tent frame, and a bed base. It is designed to provide a controlled and protected environment for patients who are at significant risk of injury if they fall out of bed or leave the bed without assistance. The system allows the patient to move within a defined space while reducing the risk of falls and unsafe bed exits.

Is the FeelSafe Pro a medical device?

Yes. The FeelSafe Pro tent bed is a Class I medical device under Regulation (EU) 2017/745 on medical devices. It bears the CE marking and is subject to internal product verification and release processes. The unique serial number on the product label at the foot end of the bed supports traceability for complaints, defects, maintenance, and incident reporting.

Who is allowed to use the FeelSafe Pro?

The FeelSafe Pro is intended for use by medical professionals and trained care providers. All care providers must be fully trained before using the tent bed. They must understand the instructions for use, the warnings and labels on the product, the patient’s care plan, and the organisation’s policy on freedom-restricting measures.

For which patients is the FeelSafe Pro intended?

The FeelSafe Pro is intended for adult patients who are at high risk of injury from falling out of bed or leaving the bed without help. The patient must be at least 146 cm tall, weigh between 40 and 165 kg, and have a Body Mass Index of 17 or higher. Each patient must have an approved care plan before the FeelSafe Pro is used. For paediatric patients, the bed must only be used in the level, flat position and only under appropriate medical authority and supervision.

Is the FeelSafe Pro a freedom-restricting intervention?

Yes. When used with closed access panels, the FeelSafe Pro restricts the patient’s freedom. The same rules apply as for other freedom-restricting measures. It must only be used when clinically justified, when prescribed or authorised by the appropriate medical authority, and when there is no suitable less restrictive alternative. The device should always be used for the shortest possible period and as part of an approved care plan.

When should the FeelSafe Pro not be used?

The FeelSafe Pro should not be used when one or more contraindications apply. Examples include aggressive, violent, or self-destructive behaviour; the presence of multiple lines, drains, or tubes; acute respiratory or cardiac support needs; cardiogenic or septic shock; claustrophobia; PICA eating disorder; suicide risk; use in critical care environments such as an ICU; patient size or weight outside the permitted limits; and situations where breathable materials are medically required to prevent breathing problems. If the patient remains restless or becomes restless in the bed, stop using the bed immediately and look for another solution with the medical team.

Can a patient be left unattended in the FeelSafe Pro?

A patient must never be left without proper monitoring. Monitoring must follow the institution’s safety policy, the medical certificate, and the patient’s care plan. During the first hours of use, the patient must be checked carefully to determine whether the FeelSafe Pro meets the patient’s needs and whether the patient is comfortable and responds well. Human Protection recommends in-room checks during the first two hours and uninterrupted auditory or visual monitoring during the following two hours.

How should the patient’s freedom and wellbeing be safeguarded?

The FeelSafe Pro must be used in combination with the patient’s individual care plan. Care providers should follow instructions about daily freedom moments outside the bed and take into account the patient’s needs for food, movement, walking, relaxation, toilet visits, and personal care. The patient and family should be informed about the call button if its use is permitted by the care plan.

Where should the FeelSafe Pro be placed?

The room must be large enough to accommodate the FeelSafe Pro and allow safe access in emergencies. There should be enough space around the bed to reach the patient quickly and to remove the patient safely if required. The bed must be positioned so the patient cannot push against, propel themselves from, or injure themselves on walls, furniture, heaters, or other objects, even when the bed is raised or adjusted.

What are the room and electrical requirements?

The room should have an easily accessible 220V wall socket near the bed. The power cord must never create a tripping hazard and must be kept away from moving parts during use and transport. The space under the bed must remain clear. Smoking is prohibited in rooms where the FeelSafe Pro is used. The bed, tent, and bed linen must never be exposed to open flames, smoking materials, mobile heaters, or other heat sources.

Who should install or assemble the FeelSafe Pro?

Assembly should preferably be carried out by two people to ensure stability and prevent injury. The tent must be fitted correctly over the frame, all zips must be closed correctly, and the foam padding must remain in place around the frame. The plastic seal around the foam padding must not be removed. After assembly, the mattress must be placed in the mattress compartment and the compartment must be fully zipped closed.

Which mattresses may be used?

The mattress compartment is designed for a comfort mattress measuring 90 x 200 x 12 cm. The mattress must always be fully enclosed in the mattress compartment. The FeelSafe Pro is not suitable for air mattresses. In the patient space, only the supplied Human Protection top mattress of 5 cm thickness may be used. Using another top mattress can create a suffocation risk.

What is the self-open set?

The self-open set is an inner pull cord that can be attached to the zip puller on the inside of the right-hand panel. When used, it allows the patient to open the FeelSafe Pro from within. The cord can also be removed so the bed cannot be opened from within. If the snap buckles are closed, they override the self-open function. Whether this function is used must be decided carefully and must fit the care plan and the intended degree of freedom.

What must be checked before leaving the patient unattended?

Before leaving the patient unattended, care providers must always review the safety checklist and confirm that the bed is safe, correctly positioned, and used according to the care plan. This includes checking the tent and mesh, mattress placement, hygiene, bed height, castors, zips, quick-release fasteners, bed location, drainage openings, call button, and the position of the lying surface.

How do care providers access the patient?

The FeelSafe Pro has four access panels: two side panels, one panel at the head end, and one panel at the foot end. The side panels can be opened fully and secured at the top with Velcro strips, allowing care providers to reach the patient. Before opening a panel, ensure that the patient is in a safe position and cannot fall. After care, close the panel using the zip pullers, secure the quick-release fastener, and test the zip along its full length.

How should the zips be used safely?

Always use the zip pullers to open and close the panels. Never pull the panels open by force, as this can damage the fabric, zips, or sliders. Inspect the zips for wavy sections, misalignment, damaged sliders, broken teeth, missing pullers, or gaps. Never use the bed if a zip is damaged, incorrectly closed, or does not function properly.

What are quick-release fasteners used for?

Quick-release fasteners provide additional security by connecting to the zip pullers and reducing the risk of the patient opening the tent bed independently. After closing a fastener, always pull on the clip to verify that it is securely locked. Damaged or non-functioning fasteners must be replaced immediately.

How can the tent be opened in an emergency?

In an emergency, first try to open the tent normally using the zip on the side panel. If that zip fails, try another access panel. If the zips are inaccessible or fail to open, dressing scissors may be used to cut the mesh so the patient can be helped quickly. Emergency procedures, including resuscitation procedures, must always be aligned with the institution’s own policy.

How should the tent and mattresses be cleaned?

The tent and mattresses should be wiped with a clean cloth using an all-purpose cleaner dissolved in water, following the dosage instructions on the cleaning product, or with a damp microfibre cloth. Do not use abrasive products on the tent. After cleaning, wipe the surfaces dry with a clean, dry cloth. For the bed base, always follow the bed base manufacturer’s cleaning instructions.

When is disinfection required?

Disinfection is required when the tent, bed base, or mattresses are contaminated with blood or other bodily fluids, or when final disinfection is indicated for a patient with an infectious disease such as Norovirus or particularly resistant micro-organisms. Blood and bodily fluids must be thoroughly removed before disinfectant is applied. Use a CTGB-approved disinfectant and follow the product instructions, including the required contact time.

How should the tent be washed?

The tent must always be washed before use with a new patient. Close all zips and Velcro strips before washing to prevent damage. Wash the tent at a maximum temperature of 30°C to prevent shrinkage and wear. Use a bactericidal detergent where appropriate. Use an extra-large washing machine with a capacity of at least 18 kg, wash one tent at a time, use no more than 50% of the machine load capacity, use a high water level, and spin at a maximum of 500 rpm. Remove the tent immediately after washing and air dry it completely before reuse.

Which cleaning products must not be used?

Never use bleach, harsh detergents, solvents, or abrasive products. Excessive heat or aggressive chemicals may damage the fabric backing and reduce the water-repellent properties of the tent. Do not remove the foam mattress from its cover for cleaning or disinfection. Do not clean the foam rolls on the frame, as this can damage the foam and make it unusable.

How often must the FeelSafe Pro be inspected?

The tent and frame must be inspected at least once a month and before use with a new patient. Maintenance staff should also inspect the device whenever the tent has been removed for washing. The inspection should include the tent fabric, mesh, zips, sliders, Velcro, quick-release fasteners, top mattress, comfort mattress, foam rolls, frame, correct placement of the tent on the bed base, and the presence of the manual and self-open set.

What is the expected service life?

With average use, the expected service life of the FeelSafe Pro tent is 5 years or 50 washes, provided it is cleaned and maintained according to the instructions for use. If any part does not function properly during use, the bed must be taken out of service immediately and Human Protection B.V. must be contacted for replacement or repair.

When must the bed not be used?

Never use the FeelSafe Pro if the tent frame is damaged, if zips cannot be opened or closed easily and securely, if the frame is bent or damaged, if the frame is not correctly attached to the bed, if parts are missing, or if the tent, panels, mesh, fasteners, or mattress components are damaged. Remove the patient from the bed immediately if a safety issue is identified.

How should the FeelSafe Pro be stored?

The device is intended for normal indoor environments. It may be stored in a warehouse or storage space with normal ambient temperature and humidity. Avoid high humidity and excessive moisture, as these may damage the product materials. Recommended use conditions are a temperature of +10°C to +40°C and relative humidity of 30% to 75%. Recommended storage conditions are a temperature of +5°C to +45°C and relative humidity of 30% to 75%.

How should the bed be moved?

Use the transport handles located at the corners of the bed. Before moving the bed, make sure the lying surface is flat and horizontal, unplug the power cord and secure it to the designated Velcro strap, check the castors, lower the bed surface, and unlock the central wheel brakes. After moving the bed, reconnect the power cord and keep it away from moving parts.

Which accessories may be used?

Only accessories recommended by Human Protection B.V. may be used. Available accessories include the 12 cm comfort mattress, the 5 cm memory foam top mattress, and the resuscitation board with cover. Accessories that are not recommended may create risks for the patient or damage the product.

Why is a zip difficult to open or close?

A zip may be difficult to use if fabric, bedding, dirt, or other material is caught in it. Gently pull the zip in the opposite direction until it becomes free. Then inspect the tent for damage, wear, holes, and broken zip teeth. Always use the zip puller and never force the access panel open.

Why does the zip split after closing?

If the zip splits after closing, the slider may be damaged and may no longer align the zip teeth correctly. Do not use the FeelSafe Pro in this situation. Contact Human Protection B.V. to arrange repair and, if needed, a replacement bed.

What should I do if the patient scratches the mesh?

Remove the patient from the tent bed and consult the physician, medical team, or care plan to determine the appropriate care response. Scratching or damaging the mesh can compromise patient safety and product integrity.

Can IVs, drainage lines, monitoring lines, or call buttons be used?

Yes, but only if included in the medical certificate or care plan and only through the designated drainage openings. Never pass lines through the mesh. Ensure the line flow is not obstructed and check that lines do not become trapped when the bed is raised or lowered. Use of lines with agitated or aggressive patients must be approved by the physician or medical team and may require additional monitoring.

Can a hoist be used with the FeelSafe Pro?

Most hoists can be used in combination with the FeelSafe Pro, provided there is enough clearance under the tent frame. The leg height of the hoist should be no more than 13 cm. The access panel on the opening side measures approximately 110 x 178 cm, allowing transfers with many hoists. Always check the institution’s transfer policy and the patient’s care plan before using a hoist.

Who should be contacted for defects, incidents, repairs, or replacement parts?

Defects, complaints, incidents, repair requests, and replacement part orders should be reported directly to Human Protection B.V. Always provide the product’s serial number when reporting an issue. Human Protection B.V. can also provide information about service and maintenance contracts, replacement beds, and repair options.

This FAQ is a practical support document and does not replace the official instructions for use, the patient’s approved care plan, clinical judgement, institutional protocols, or applicable legal requirements.