Hillrom NP50 Monodensity High Resilience Foam Mattress Instructions

Monodensity High Resilience Foam
Mattress Instructions

Safety and Usage Tips

• Intended Use
  The NP50 mattress benefits are pressure ulcer prevention help. It is suitable for low to moderate-risk adult patients, within a recommended weight range of 30 kg and 150 kg.
  Environment
  It can be used as a mattress in the following environments, as defined in the standard IEC 60601-2-52:

• Application environment 1 (acute care);

• Application environment 2 (short-term care in hospitals or other medical establishments);

• Application environment 3 (long-term care in medical establishments);

• Application environment 5 (outpatients or ambulatory care).

Contraindications
The NP50 mattress is not designed to come into direct contact with damaged skin and it is not suited to patients with atypical anatomies.
Intended Users
The NP series mattresses are designed to be used by Qualified Staff for patient care from several care application environments.
First Use
Hill-Rom recommends that the mattress be disinfected before first use.
User Instructions
Carefully read all the instructions. Failure to do so could result in equipment damage and injury.
Understanding the Symbols

| Manufacturer
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| Device Reference
| Batch Code
| CC (Country Code): Country of manufacture
Date of Manufacture (YYYY-MM-DD)
| Medical Device

Hillrom™ NP50 Monodensity High Resilience Foam Mattress Instructions for Use

| Unique Device Identification
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| A safe Working Load is the greatest permissible load that can be applied after which damage may occur on the mattress. Safe working load, including the total weight of the patient, accessories, and the load supported by these accessories.
| Medical Device conformity mark
| Biological Hazard Warning
| WARNING
This symbol indicates that the failure to follow the associated recommendation can put the patient or the user in danger, or damage the device.
| Refer to the Instructions For Use
| Does not contain natural latex in accordance with ISO 7000

Before Placing the Patient on the Mattress
Remove the NP50 mattress from its polyethylene packaging. Take care not to damage the mattress with scissors or cutters. Check that the zip fastener is fully closed. Store the mattress at ambient temperature (18 to 20°C) for at least 24 hours. Make sure that the mattress is correctly installed and well centered on the sleep surface. Cover the mattress with a sheet to avoid direct contact between the patient’s skin and the surface of the mattress.
Complying with Conditions for Use

Supervision is advisable if the top edge of the side rail is less than 22 cm above the mattress. When the patient is left unattended, it is recommended to place the bed in the lowest position.
Failure to properly assess the fit of the NP50 mattress and bed frames could result in the risk of entrapment which may cause serious injury or death.

• If necessary, place a plate between the patient and the mattress when performing cardio-pulmonary reanimation (external heart massage).

Transferring the Mattress from one Bed to Another
Never leave the patient on the mattress during transfer.
Make sure that the bed chassis brakes are applied to prevent any accidental movements. If the mattress has handles, use them to transfer the mattress more easily. While handling the mattress, all necessary precautions must be taken to avoid any damage. Do not work on the device when it is occupied.

Cleaning and Disinfecting

Cleaning and disinfection are two separate procedures.
Complying with Safety Instructions

• Check that the brakes are applied on the bed on which the mattress is installed.
• Lock out all electric functions.
• Never clean the mattress by pouring water on it, nor with a high-pressure jet.
• Never use water at a temperature of more than 70°C.
• Refer to the recommendations of the cleaning and disinfecting of the product provided by the manufacturer.
• Thoroughly dry the mattress before reusing it.
• Suitable individual protective equipment must be worn during the steps of the cleaning operation (blouse, gloves, eye protection, etc.).

Failure to implement one or more of these recommendations may lead to damage or deterioration, preventing the use of the device and rendering the warranty void.

Controlling Infection

Insufficient Cleaning = Risk of Infection (biological danger)!
All parts must be kept clean at all times in order to avoid the risk of infection. All necessary precautions must be taken to eliminate all visible soiling.

The following recommendations are not designed to replace cleaning and disinfection protocols drawn up by the hygiene officer or by other bodies for your hospital in the event f particular infectious situations.

**Complying with Manufacturer Recommendations

**

The cleaning and disinfecting method described below applies specifically to the mattress and its accessories and is designed to save time and help combat nosocomial infection more effectively.

Hill-Rom recommends that the mattress be disinfected before first use. When cleaning, always check the cover for cuts, tears, cracks, or snags; never use a mattress with a damaged cover. If the internal foam of the mattress is soiled and presents a risk of infection, then replace the mattress. Following other cleaning and disinfection protocols or using other products than those recommended by Hill-Rom may compromise devices and patient safety,  and void the warranty.

De-commissioning
Hill-Rom recommends that the mattress should be disinfected before de- commissioning. Customers should adhere to all federal, state, regional, and/or local laws and regulations as it pertains to the safe disposal of medical devices and accessories. If in doubt, the user of the device shall first contact Hill-Rom Technical Support for guidance on safe disposal protocols.

Products To Be Avoided
Never use cleaning agents, detergents, degreasing agents or industrial solvents containing any of the following products in order to avoid damaging the mattress:

| Phenol| | Cresol
---|---|---|---
| Hydrochloric,
Nitric or Sulfuric Acids| | Soda
| Dimethylformamide| | Tetrahydrofuran

Do not use highly acidic detergents or disinfectants (pH<4). Do not use highly basic detergents or disinfectants (pH>10). Never use abrasive cleaning materials or products,  such as scouring pads.

Cleaning and Disinfecting after the Departure of a Patient or when Changing the Sheets Using Recommended Products

• Terralin® Protect (Schülke) 1
  Concentration: 5 ml/l (= 0.5%), contact time: 1 h.
  

Cleaning
Clean the mattress with a cloth slightly dampened with hot water and a neutral detergent solution. Check that the solution does not contain any of the products to be avoided mentioned above.

Cleaning Tough Stains
Quickly wipe away any traces of pharmaceutical solutions used for the patients to avoid permanent damage to the surface.

• Remove tough stains with a soft brush and neutral detergents or a chlorine-based solution with a concentration less than or equal to 1,000 ppm or 10,000 ppm according to labeling.
• To eliminate hardened stains (excreta, and other forms of soiling), soften them by soaking them and take care to thoroughly dry the cover before putting it back on the mattress.
  

1. Terralin® Protect is listed by the V.A.H (Verbund für Angewandte Hygiene e.V.).

Disinfecting

In the event of visible soiling, Hill-Rom recommends that the mattress should be disinfected with an intermediate disinfectant  (tuberculocidal) that complies with the applicable regulations (e.g. with the requirements of regulation 2017/745/EEC).
For all other disinfectants:

| Chlorine-based solutions can be used. Concentration must be less than or equal to 1,000 ppm.
---|---
| Ethanol (alcohol) can be used. Concentration must not exceed ¼ of ethanol for ¾ of water.

Proceed with the final steps before reusing the cleaned and disinfected mattress (See “Performing the Final Steps”, page 3).

Cleaning and Disinfecting at Regular Intervals or in the Event of High

Risk of Contamination

Follow the same instructions as above Go to “Cleaning and Disinfecting after the Departure of a Patient or when Changing the Sheets” on page -2., but with the products listed below.

Using Recommended Products

After the departure of patients with infectious diseases:

• Dismozon® Pur (Bode) 1 Concentration: 40 g/l (= 4%), contact time: 1 h
  After the departure of patients with Clostridium Difficile:

• Dismozon® Pur Concentration: 15 g/l (= 1.5%), contact time: 2 h

• Anioxy-Spray WS (Anios) Ready to use, contact time: 30 min
  Dry Steam Cleaning the mattress
  Dry steam or superheated steam contains no more than 6% of water in suspension and avoids the effects of condensation. To avoid damage due to high pressure or an abnormal surface temperature, take the following precautions:

•  Do not use accessories such as high-pressure hoses (A). It is preferable to use soft non-metallic brushes (B) and wipers (C) in such a way as to reduce the pressure to an acceptable level.

• Do not brush and apply reduced pressure to labels and markings.

• Dry carefully and look for signs of water ingress before reusing.

Hill-Rom recommends the use of the Sanivap® method:

• Application time recommended by the supplier: approximately1 sec.
• Distance (recommended by the supplier) between the source and the surface to be disinfected: approximately 3 mm.
• Application: exterior parts of the mattress (covers).
• Frequency: for each new patient.

Machine Washing the Mattress Cover
Do not always machine-wash, as doing so will reduce the lifetime of the components. Machine-wash only if particular risks of infection occur.

| Maximum temperature: 70°C Delicates
---|---
| Only clean with oxygenated agents
| Do not iron
| Do not dry clean
| Can be tumble dried Moderate temperatures: 50° C

Reinstalling the cover
When reassembling the cover after machine washing, make sure to match with the associated foam Go to “Mattress/foam/cover combinations” on page -3.
Orientate properly the cover on the foam regarding the marking located on the foam in the feet area toward the top.

Mattress / foam / cover combinations

Performing the Final Steps

• Always remove all traces of the products used when washing or disinfecting the mattress.
• Make sure that all the parts of the mattress are perfectly dry before installing to avoid any risk of condensation forming inside the mattress.

Complying with Conditions for Transport and Storage

*Applicable only if the mattress is transported or stored in its original packaging.
The mattress must be stored in its original packaging:

• Protected against light and damp;
• At least 10 cm above floor level to prevent fluid ingress;
• Protected against dust;
• Outside passageways.

Never stack more than 15 mattresses.

1. Dismozon® Pur is listed by the V.A.H (Verbund für Angewandte Hygiene e.V.).

Specifications

The NP50 mattress must only be used with the covers mentioned in the Spare Parts list (see page 4). Mattress weight: 10 kg.

Spare Parts

For any information about spare parts, please give the reference printed on the side of the mattress when you call.

Cover references

NOTE: The color of the cover may vary and is non-contractual.

Accessories

The Mattress Extensions are provided to extend the mattress length.

Hillrom™ is a trademark of Hill-Rom Services, Inc. Terralin® is a registered trademark of Schülke & Mayr GmbH. Dismozon® is a registered trademark of Bode Chemie mbH. Sanivap® is a registered trademark of Sanivap S.A. Translation of the original instructions.

Regulatory Requirements

The CE conformity mark applicable to class I MedicalDevices was applied for the first time in 2008.

The mattresses meet the following standards:
All mattresses

• EN ISO 10993-1:2009
• EN ISO 10993-5:2009
• EN ISO 10993-10:2010
• EN 597-1:2015
• EN 597-2:2015
• GPEM/CP – Guidelines D1-90, February 1991 (France)

In addition for the Mattress ASS007

• UNI 9175
• BS 6807:2006 Clause 9 (Crib5)
• BS 7177:2008 for medium hazard

Country of manufacture (ISO 3166-1)

| FR: FRANCE
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| CN: CHINA

Contacts

Notice to Users and/or Patients:
Any serious incident that has occurred in relation to the device, should be reported to the manufacturer and the Competent Authority of the Member State in which the user and/or patient is established.
For any request or to order copies of this manual contact your national Hill- Rom representative or go to hillrom.com and order the article with the part number 163791.
Hillrom™ is a trademark of Hill-Rom Services, Inc.
Terralin® is a registered trademark of Schülke & Mayr GmbH.
Dismozon® is a registered trademark of Bode Chemie GmbH.
Sanivap® is a registered trademark of Sanivap S.A.
Translation of the original instructions.

Hill-Rom S.A.S. Z.I. du Talhouet 56330 PLUVIGNER – FRANCE
Hill-Rom S.A.S. meets the ISO 13485 and ISO 9001 standards hillrom.com
© 2022 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.
June 2022
163791(11)

References

• Advancing Connected Care | Hillrom

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