Human Protection · FeelSafe Go · EA003

Important principle

Basic knowledge

What is the FeelSafe Go?

The FeelSafe Go is a tent bed consisting of a bed tent installed on a bed base. The bed tent forms a small, defined environment around the person in bed. Its purpose is to provide a sense of security and reduce external stimuli.

Is the FeelSafe Go a medical device?

Yes. The FeelSafe Go is classified as a Class I medical device under Regulation (EU) 2017/745 on medical devices (MDR) and bears the CE marking.

What is the difference between a bed tent and a tent bed?

The instructions for use describe a bed tent as a standalone construction installed on top of a bed base that forms a safe or shielded space around the person in bed using textile panels. A tent bed is the combination of this bed tent with the bed base, intended to be used as a single unit.

Is the FeelSafe Go freedom-restricting?

No. This is an important characteristic of the FeelSafe Go. The bed tent is designed to provide a sense of security without being freedom-restricting. The side panels are not closed off, but fall shut.

Can the user leave the FeelSafe Go independently?

Yes. Care professionals must take into account that the user can leave the FeelSafe Go via both long sides.

Does the FeelSafe Go prevent someone from rolling out of bed?

No. The FeelSafe Go does not prevent someone from rolling out of bed. The FeelSafe Go is therefore not suitable for patients with an increased risk of falling.

Does the FeelSafe Go prevent someone from unintentionally getting out of bed?

No. The bed tent has no function that prevents the user from leaving the bed independently. The instructions for use explicitly warn that the FeelSafe Go does not prevent the user from leaving the bed unintentionally.

Indication and preparation

What is the FeelSafe Go intended for?

The FeelSafe Go is intended to provide a sense of security and fewer external stimuli. The user is given a safe, defined but non-freedom-restricting space.

For which users can the FeelSafe Go be suitable?

According to the instructions for use, the FeelSafe Go can be used for people with forms of:

• restlessness;
• disorientation;
• impulsive behaviour;
• agitation;
• anxiety.

Can the FeelSafe Go help with sensory sensitivity?

The intended purpose of the FeelSafe Go is to create a sense of security and reduce external stimuli by providing a small, defined space.

Who may use the FeelSafe Go professionally?

According to the instructions for use, this medical device is intended for use by medical professionals.

Must care providers be trained in advance?

Yes. All care providers must be fully trained in the use of the following before use:

• the FeelSafe Go tent bed;
• the bed tent;
• the associated bed base.

Must the care provider know the care plan?

Yes. Care providers must know the user’s care plan before use. They must also know how closely and how often the user must be checked.

Must the user be introduced to the FeelSafe Go beforehand?

Yes. The user must be made familiar with the tent before use. Nursing staff must inform the user about the functions that are relevant to them.

Safe application

The instructions for use list the following contraindications:

• increased risk of falling;
• need for back support in order to stand;
• multiple lines, drains, and/or tubes;
• claustrophobia;
• suicidal ideation.

Use is also discouraged for people with an increased risk of suffocation. If a care professional has determined that breathable materials in bed are necessary to prevent breathing problems, this device is not suitable.

Is the FeelSafe Go suitable for someone with an increased risk of falling?

No. An increased risk of falling is explicitly included as a contraindication. The FeelSafe Go does not prevent someone from rolling out of bed or leaving the bed unintentionally.

Can the FeelSafe Go be used for claustrophobia?

No. Existing claustrophobia is a contraindication. The instructions for use also state that the FeelSafe Go is not suitable for users who become claustrophobic during use.

Is the FeelSafe Go suitable with multiple lines, drains, or tubes?

No. The presence of multiple lines, drains, and/or tubes is listed as a contraindication in the instructions for use.

Can the FeelSafe Go be used with an increased risk of suffocation?

Use in people with an increased risk of suffocation is discouraged. If it has been determined that breathable materials in the bed are necessary to prevent breathing problems, use of the FeelSafe Go is not suitable.

What should I do if the user may injure themselves or others?

Remove the user from the FeelSafe Go tent bed immediately when there is a risk of self-injury or injury to others.

What should I do if the user tries to damage the tent?

Even when the user tries to damage the FeelSafe Go, the user must be removed from the tent bed immediately according to the instructions for use.

How should the user be monitored during first use?

During the first hours, careful checks must be made of:

• whether the FeelSafe Go meets the user’s needs;
• whether the user is lying comfortably;
• whether the user responds well to the tent bed.

What monitoring does Human Protection B.V. recommend during first use?

Human Protection B.V. recommends checking in the room for the first two hours. During the following two hours, uninterrupted audio or visual monitoring is recommended.

Must checks still be carried out after that?

Yes. During further use, it must also be carefully assessed whether the FeelSafe Go continues to meet the user’s needs and whether the user is lying comfortably and responding well to the bed tent.

What happens if the physical or mental condition changes?

When the user’s mental or physical condition or status changes, it must be reassessed whether use of the FeelSafe Go is still necessary and appropriate.

Preparing the environment

How is the FeelSafe Go delivered?

The FeelSafe Go bed tent is delivered installed on a bed base. Upon delivery, it must be checked that the delivery is complete and undamaged. Damage or defects must be reported to the supplier in writing immediately.

Where should the tent bed be placed in the room?

Position the tent bed so that the user cannot injure themselves on:

• walls;
• furniture;
• other objects.

This must also remain safe when the bed base is raised.

Must the bed be accessible from both sides?

Yes. Make sure the FeelSafe Go tent bed is accessible from both long sides.

Why is placement especially important?

The user can leave the FeelSafe Go via both long sides. The positioning of the tent bed must take this into account.

In which position should the bed base be?

The bed base must always be in the lowest position, except during care moments.

Must the wheels be locked?

Yes. The wheels of the bed base must be locked during use. They are only unlocked when the bed is being moved. An unlocked bed can move when the user shifts position or gets out of bed, which can cause injury.

May the tent frame be damaged or bent?

No. Never use the FeelSafe Go when the tent frame is bent or broken.

How is the tent reassembled after washing?

According to the instructions for use, the tent is pulled over the blue tent frame, with the Human Protection logo placed on the long side. The four upper Velcro connections are then attached to the tent frame, and the Velcro around the four legs is secured.

How should the foam protection be reinstalled?

The U-shaped foam profile must have its open side facing the short side, so that the user is fully protected against the frame on the inside. The foam padding is placed back in the cover and attached to the long sides of the tent frame. The padding must sit on the top and inside of the frame, with the Velcro on the underside.

Before every use

Check the tent

• Is the tent clean and not contaminated?
• Are there no tears?
• Are there no thin or worn spots?
• Are the seams intact?
• Does the Velcro function properly?

Check the construction

• Is the bed tent correctly assembled?
• Are the parts in good condition?
• Are no parts missing?
• Is the tent frame not bent or broken?
• Are fasteners and connections securely attached?

Check the bed base and environment

• Is the bed base in the lowest position?
• Are the wheels locked?
• Is the bed accessible from both long sides?
• Can the user not injure themselves on walls, furniture, or other objects?

Check the care situation

• Does the use still fit the care plan?
• Is it clear how and how often the user must be checked?
• Is the user lying comfortably?
• Does the user respond well to the FeelSafe Go?
• Has the mental or physical condition changed?

What if damage is found during the check?

Do not use the FeelSafe Go if damage or defects could pose a danger to people. A FeelSafe Go with a bent or broken tent frame, or a worn or damaged tent, must not be used.

Access and exit

How does the user access and exit the FeelSafe Go?

The FeelSafe Go has side panels that are not closed off but do fall shut. This allows the user to leave the FeelSafe Go via both long sides.

Are the side panels closed off during use?

No. That is precisely an essential part of the non-freedom-restricting design: the side panels are not closed, but they do fall shut.

Do the panels prevent the user from getting out of bed?

No. Care providers must be explicitly aware that the user can leave the FeelSafe Go via both long sides. The FeelSafe Go does not prevent the user from leaving the bed unintentionally.

Must the space outside the side panels be taken into account?

Yes. Because the user can leave the bed via both long sides, the tent bed must be positioned so that the surroundings are safe and the user cannot injure themselves on walls, furniture, or other objects. In addition, the bed must be accessible from both long sides.

How should zips and quick-release fasteners be used?

The available instructions for use do not describe a closing function for the side panels using zips or quick-release fasteners as with a closed tent bed. The instructions for use explicitly state that the side panels are not closed. Therefore, the zip and quick-release fastener instructions for the FeelSafe Pro must not be applied to the FeelSafe Go.

Hygiene and infection prevention

How do I clean the FeelSafe Go?

According to the instructions for use, the FeelSafe Go can be cleaned in accordance with the SRI guidelines for infection prevention. Wipe the tent with a clean cloth using an all-purpose cleaner dissolved in water according to the prescribed dosage, or with a microfibre cloth dampened with water.

Do not use abrasive agents. After cleaning, wipe the tent dry with a clean, dry cloth.

When should the FeelSafe Go be disinfected?

Disinfection is necessary in the event of contamination with blood or other bodily fluids, or for terminal disinfection when a user has an infectious disease for which disinfection is indicated. The instructions for use mention, among other things, norovirus and particularly resistant micro-organisms.

How do I handle blood or other bodily fluids?

Blood and other bodily fluids must first be thoroughly removed from all surfaces before a disinfectant is applied.

Which disinfectant may be used?

Use a CTGB-approved disinfectant and follow the instructions for the relevant product, including the prescribed contact time. Then remove excess disinfectant with a clean, dry cloth.

Must the tent be washed when changing clients?

Yes, always. When changing clients, also clean or disinfect the bed base and mattresses to prevent infections and transmission of micro-organisms.

How is the tent prepared for washing?

1. Remove the mattress and bed linen.
2. Check the blue tent frame for damage and loose parts.
3. Loosen the Velcro connections between the bed frame and the tent frame.
4. Loosen the padding on the long sides.
5. Remove the foam padding from the cover.
6. Loosen the connections around the four legs.
7. Loosen the four upper Velcro connections.
8. Carefully remove the tent from the tent frame.
9. Close all Velcro fasteners again before washing.

Why must the Velcro be closed during washing?

The rough side of the Velcro can damage the mesh during washing and attract dirt. Therefore, the Velcro must always be closed before the tent is washed.

How can the Velcro be cleaned?

After repeated use or washing, dirt can reduce adhesion. Check before every use whether the Velcro still works properly. Dirt can be removed with a stiff brush.

At what temperature may the tent be washed?

The maximum wash temperature is 30 °C to prevent shrinkage and wear. The use of a bactericidal detergent is strongly recommended.

Which washing machine should be used?

The instructions for use prescribe a machine with an extra-large capacity of at least 18 kg. Wash one tent at a time, use a maximum of 50% of the machine capacity, and a high water level. Let the machine fill completely with water before adding the cleaning agent.

At how many revolutions may the tent be spun?

At a maximum of 500 revolutions.

May the tent go in a tumble dryer?

The instructions for use prescribe that the tent be air-dried after washing. The tent must be completely dry before it is used again.

May our organisation wash the tent itself?

When an organisation chooses to wash or disinfect the tent itself, the instructions for use require prior consultation with Human Protection B.V. about the cleaning agent, machine settings, and the cleaning and disinfection process.

Without explicit approval of the process, the instructions for use state that no guarantees can be given regarding the wash result, hygienic safety, or service life.

Human Protection B.V. can also wash the tent via a specially designed washing process.

What must be checked after cleaning?

After every cleaning, the FeelSafe Go must be checked for tears, holes, and wear. Damaged parts must be repaired or replaced.

Technical reliability

How often must the FeelSafe Go be inspected?

Parts that may wear or deteriorate in quality due to use, cleaning, and disinfection must in any case be inspected every three months.

What must be checked during this inspection?

• whether parts are missing or damaged;
• whether fasteners and connections are securely attached;
• whether fasteners show no signs of wear;
• whether the tent frame is in good condition;
• whether the tent frame is not bent or deformed.

Who may carry out maintenance?

Special maintenance work must be carried out by an authorised person, for example the technical service of a care institution.

May I repair a defective part myself?

No. The instructions for use state that defective parts must not be repaired independently. Repairs to the FeelSafe Go tent bed may only be carried out by Human Protection B.V.

What is the expected service life of the FeelSafe Go?

The expected service life of the FeelSafe Go tent bed is 5 years or 50 washes.

How long does the warranty last?

The warranty applies until one year after purchase, with the invoice date being decisive. If the tent was first rented and then purchased, the date on which the first rental started applies.

Is all damage covered by the warranty?

No. The warranty excludes, among other things, damage resulting from use under unsuitable conditions, incorrect use or maintenance, misuse, abuse, unauthorised modifications or repairs, extreme heat or cold, and certain external causes such as flooding or fire.

Technical data

Under what conditions may the FeelSafe Go be used?

The FeelSafe Go may be used indoors at:

• an average temperature of +10 °C to +40 °C;
• a relative humidity of 30% to 75%.

May the FeelSafe Go be used outside these conditions?

The instructions for use stipulate that it is not permitted to use the FeelSafe Go for purposes or under conditions other than those described in the manual.

What must be taken into account when moving the bed?

The wheels must be locked during use, except when the bed is being moved. After positioning, the wheels must therefore be locked again.

How large is the tent bed?

The dimensional drawing in the instructions for use states, among other things, a total length of approximately 228.5 cm, a width of approximately 93.5 cm, and a tent construction height of approximately 120 cm. The same drawing shows 193 cm and 89 cm for the tent.

How heavy are the parts?

• standard supplied bed base: 93.2 kg;
• FeelSafe Go tent: 3.2 kg;
• FeelSafe Go tent frame: 7.4 kg.

May the FeelSafe Go be modified?

Not without permission from the manufacturer. According to the instructions for use, modified material must be appropriately checked and tested to continue to guarantee safe use.

Which accessories can be used?

The available instructions for use do not contain a separate list of approved accessories for the EA003. Therefore, no accessories from the FeelSafe Pro FAQ are deliberately included.

How is the FeelSafe Go disposed of at the end of its service life?

The FeelSafe Go contains metal, fabric, and plastic parts. The individual parts must be disposed of in accordance with applicable local regulations.

If something goes wrong

What should I do if I discover a tear or hole?

Stop using the device if the damage could pose a danger. The instructions for use also prescribe checking the tent for tears, holes, and wear after cleaning. Damaged parts must be repaired or replaced.

What should I do if the tent frame is bent or broken?

Do not use the FeelSafe Go. The instructions for use explicitly warn never to use the bed when the tent frame is bent or broken.

What should I do if the Velcro no longer adheres properly?

Check before every use whether the Velcro is functioning properly. Dirt can be removed with a stiff brush.

What should I do if the user is lying uncomfortably or not responding well?

Carefully check whether the FeelSafe Go still meets the user’s needs. The instructions for use prescribe continuing to assess during use whether the user is lying comfortably and responding well to the bed tent.

What if the user becomes claustrophobic?

The FeelSafe Go is not suitable for users who are or become claustrophobic. In that case, use must be reconsidered.

What if the user tries to damage the tent?

When the user tries to damage the FeelSafe Go, the user must be removed from the tent bed immediately according to the instructions for use.

What if a risk of self-injury or injury to others arises?

Remove the user from the FeelSafe Go tent bed immediately when there is a risk of self-injury or injury to others.

What if the user’s physical or mental condition changes?

Reassess whether use of the FeelSafe Go is still necessary and appropriate.

What if the user gets out of the FeelSafe Go independently?

The possibility that the user leaves the bed independently is inherent to the design of the FeelSafe Go. The FeelSafe Go is not freedom-restricting and does not prevent someone from leaving the bed. The manual prescribes positioning the bed so that the user cannot injure themselves on walls, furniture, or other objects.

What should I do if a defect occurs during use?

Stop using the device if a defect occurs. Do not try to repair defective parts yourself, and contact Human Protection B.V. in the event of product issues.

Where can I find the serial number?

The unique serial number is located on one of the short sides of the bed. Always note the serial number when reporting a defect, complaint, or incident.

Where do I report a defect, complaint, or incident?

Human Protection B.V.
Droogdokkeneiland 4
5026 SR Tilburg
Nederland
E-mail: info@humanprotection.nl
Phone: +31 (0)13 536 38 07

What must happen in the event of a serious incident?

Serious incidents must always be reported to Human Protection B.V. and to the responsible local authorities.

Key message

The FeelSafe Go is intended to provide a sense of security and reduce external stimuli. It is not a freedom-restricting tent bed. The side panels are not closed off, and the user can leave the bed via both long sides. The FeelSafe Go does not prevent someone from rolling out of bed or leaving the bed unintentionally.

This FAQ is intended as practical support for care professionals and other stakeholders. The FAQ does not replace the official instructions for use, the individual care plan, or professional clinical judgement. The official instructions for use must be kept for reference.