Spare Parts; Regulatory Requirements - Hillrom NP150 Viscoelastic Instrucciones De Uso

Specifications
Ref.
Country
Mattress
NP150 Viscoelastic
ASS033 Europe except GB, IT
ASS034 Europe except GB, IT
ASS048 Europe except GB, IT
ASS004XT GB - IT
ASS075 Europe except GB, IT
ASS076 Europe except GB, IT
ASS081 Europe except GB, IT
NP150 Viscoelastic X-Ray
ASS095 Europe except GB, IT
ASS099 Europe except GB, IT
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
NP150 Viscoelastic
TEX033 ASS033
TEX034 ASS034
TEX048 ASS048
ASS004XT /
a
TEX004XT
ASS004
TEX075 ASS075
TEX076 ASS076
TEX081 ASS081
NP150 Viscoelastic X-Ray
TEX095 ASS095
TEX099 ASS099
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.
®
© 2020 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.
May 2020
PROPRIETARY AND CONFIDENTIAL DRAFT: 19 June 2020
Ref.
Dim. / cm
Cover
TEX033 14 x 85 x 198
TEX034 14 x 90 x 198
TEX048 14 x 90 x 203
TEX004XT 14 x 85 x 198
TEX075 14 x 80 x 190
TEX076 14 x 90 x 198
TEX081 14 x 80 x 210
TEX095 14 x 85 x 198
TEX099 14 x 90 x 198
Type of seam Dim. / cm
Welded 14 x 85 x 198
Welded 14 x 90 x 198
Welded 14 x 90 x 203
Welded 14 x 85 x 198
Welded 14 x 80 x 190
Welded - Right
14 x 90 x 198
Angle Corners
Welded 14 x 80 x 210
Welded 14 x 85 x 198
Welded 14 x 90 x 198
Accessories
References
ASS043 NP Mattress Extension(14 x 9 x 85 cm)
ASS044 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 marking was applied for the first time
in 2008.
CE mark applying to class I medical devices in
accordance with (see Declaration of Conformity):
• the Essential Requirements of the directive 93/42/EEC,
• the General Safety and Performance Requirements of the
Regulation (EU) 2017/745 regulation.
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
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. meets the ISO 13485 and ISO 9001 standards
164224(11) - EN
Description
Hill-Rom S.A.S.
Z.I. du Talhouet
56330 PLUVIGNER - FRANCE
hillrom.com
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