Hillrom Np150 Viscoelastic High Resilience Foam Mattress Instruction Manual

Hillrom™ NP150 Viscoelastic
High Resilience Foam Mattress
Instructions for Use  

Safety and Usage Tips

Intended Use
The NP150 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 NP150 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
	Device Reference
	Batch Code
	CC (Contry Code): Country of manufacture Date of Manufacture (YYYY-MM-DD)
	Medical Device

	Unique Device Identification
250kg	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 NP150 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

Symbol	Feature	Use
	Temperature	+10°C to +40°C
	hygrometry	30% – 85%
	Atmospheric Pressure	700 mbar – 1060 mbar

Supervision is advisable if the top edge of the side rail is less than 22 cm above the mattress.
It is recommended that when the patient is left unattended the bed be left in the lowest position.
Failure to properly assess the fit of the NP150 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 Disinfection
Cleaning and disinfection are two separate procedures.
Safety Recommendations

• Check that the brakes are applied on the bed on which the mattress is installed.
• Lock out all electrical 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 for 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 phases 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.
Infection Control

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 remove all visible stains and soiling.
The following recommendations are not designed to replace more appropriate cleaning and disinfection protocols drawn up by the hygiene officer or by other bodies of your hospital for particular infection situations.
General Recommendations
The cleaning and disinfecting method described below applies specifically to this device and all its accessories and is designed to save time and help combat nosocomial infections more effectively.
Hill-Rom recommends that the NP150 mattress be disinfected prior to 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, you are advised to replace it.
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		Tetra hydrofu ra n

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 Disinfection after the Departure of a Patient or when Changing the Sheets
Recommended cleaning products
Terralin® Protect (Schülke) 1
Concentration: 5 ml/l (=0.5%), contact time: 1h.
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.

Disinfection
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.
	Chlorine-based solutions can be used. Concentration must be less than or equal to a 10,000 ppm
	Ethanol (alcohol) can be used. Concentration must not exceed ¼ of ethanol for ¾ of water.

a. Authorized concentration on the mattress ASS004XT
Proceed with the final steps before reusing the cleaned and disinfected mattress (See “Reinstalling the cover”, page 3).
Cleaning and Disinfecting at Regular Intervals or in the Event of High Risk of Contamination
Follow the same instructions as above (See “Cleaning and Disinfection after the Departure of a Patient or when Changing the Sheets”, page 2), but with the products listed  below.
Using the Recommended Products
After the departure of patients with infectious diseases:
• Dismozon® Pur (Bode)
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 on areas with labels and markings; use reduced pressure.
• Carefully dry and check for water penetration before reuse.

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

• Application time recommended by the supplier: approximately 1 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: on each change of patient.

Machine Washing the Mattress Cover
Do not always machine-wash, as doing so will reduce the lifetime of the components. Resort to 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 (See “Mattress/foam/cover combinations”, page 3)
Orientate properly the cover on the foam regarding the marking located on the foam in the feet are toward the top.
Mattress / foam / cover combinations

Performing the Final Steps

• Always remove all traces of the products used when washing or disinfecting the device.
• 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

Symbol	Feature	Transport / Storage*
	Temperature	-30°C to +50°C
	Hygrometry	20% – 85%
	Atmospheric Pressure	700 mbar – 1060 mbar

*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.

Specifications

The NP150 mattress must only be used with the covers mentioned in the Spare Parts table (see page 4).
Mattress weight: 11 kg.
Spare parts
For any information about spare parts, please give the part number printed on the side of the mattress when you call.

Covers references

a. Cover TEX004XT replaces TEX004
NOTE :
The color of the cover may vary and is non-contractual.

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.

Accessories

The Mattress Extensions are provided to extend the mattress length.

Regulatory Requirements
The CE conformity mark applicable to class I Medical Devices was applied for the first time in 2008.

Mattresses comply with the following standards:
For 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 of February 1991 (France)

In addition for the mattress ASS004XT

• UNI 9175
• BS 6807:2006
• BS 7177:2008 for medium hazard

Country of manufacture (ISO 3166-1)

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 164224.

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

References

• Advancing Connected Care | Hillrom