Hillrom NP150 Viscoelastic High Resilience Foam Mattress Instruction Manual
- June 5, 2024
- Hillrom
Table of Contents
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
Ref.
Mattress| Ref. Foam| Ref. Cover| Dim. / cm
---|---|---|---
NP150 Viscoelastic
ASS033| UPH033| TEX033| 14 x 85 x 198
ASS034| UPH034| TEX034| 14 x 90 x 198
ASSO48| UPH048| TEX048| 14 x 90 x 203
ASS004XT| UPH004| TEX004XT| 14 x 85 x 198
ASS075| UPH075| TEX075| 14 x 80 x 190
ASS076| UPH076| TEX076| 14 x 90 x 198
ASS081| UPH081| TEX081| 14 x 80 x210
NP150 Viscoelastic X-Ray
ASS095| UPH095| TEX095| 14 x 85 x 198
ASS099| UPH099| TEX099| 14 x 90 x 198
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
Ref.
Mattress| Ref. Foam| Ref. Cover| Dim. / cm
---|---|---|---
NP150 Viscoelastic
ASS033| UPH033| TEX033| 14 x 85 x 198
ASS034| UPH034| TEX034| 14 x 90 x 198
ASSO48| UPH048| TEX048| 14 x 90 x 203
ASS004XT| UPH004| TEX004XT| 14 x 85 x 198
ASS075| UPH075| TEX075| 14 x 80 x 190
ASS076| UPH076| TEX076| 14 x 90 x 198
ASS081| UPH081| TEX081| 14 x 80 x210
NP150 Viscoelastic X-Ray
ASS095| UPH095| TEX095| 14 x 85 x 198
ASS099| UPH099| TEX099| 14 x 90 x 198
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
Ref. | Ref. Mattress | Type of seam | Dim. / cm |
---|
NP150 Viscoelastic
TEX033| ASS033| Welded| 14 x 85 x 198
TEX034| ASS034| Welded| 14x 90x 198
TEX048| ASSO48| Welded| 14x 90 x 203
TEX004XTa| ASS004XT / ASS004| Welded| 14 x 85 x 198
TEX075| ASS075| Welded| 14x 80x 190
TEX076| ASS076| Welded – Right Angle Corners| 14 x 90 x 198
TEX081| ASS081| Welded| 14x 80x 210
NP150 Viscoelastic X-Ray
TEX095| ASS095| Welded| 14 x 85 x 198
TEX099| ASS099| Welded| 14x 90x 198
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
References | Description |
---|---|
ASSO43 | NP Mattress Extension(14 x 9 x 85 cm) |
ASSO44 | NP Mattress Extension(14 x 18 x 85 cm) |
ASS077 | NP Mattress Extension(28 x 18 x 90 cm) |
ASS078 | NP Mattress Extension (20 x 21 x 85 cm) |
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
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