Spare Parts; Regulatory Requirements - Hillrom NP100 Bidensity Instrucciones De Uso

Specifications
Ref.
Country
Mattress
ASS029 Europe except GB, IT TEX029
ASS030 Europe except GB, IT TEX030
ASS031 Europe except GB, IT TEX031
ASS032 Europe except GB, IT TEX032
ASS038 Europe except GB, IT TEX038
ASS063 Europe except GB, IT TEX063
ASS035 GB - IT
ASS022XT GB - IT
ASS079 Europe except GB, IT TEX079
The NP100 mattress must only be used with the covers
mentioned in the Spare Parts list (See "Spare Parts", page 4).
Mattress weight: 10 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
TEX029 ASS029
TEX030 ASS030
TEX031 ASS031
TEX032 ASS032
TEX038 ASS038
TEX063 ASS063
TEX035 ASS035
ASS022 /
a
TEX022XT
ASS022XT
TEX079 ASS079
a. Cover TEX022XT replaces TEX022
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.
®
© 2021 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.
April 2021
PROPRIETARY AND CONFIDENTIAL DRAFT: 15 April 2021
Ref. Cover Dim. / cm
14 x 85 x 198
14 x 85 x 198
14 x 90 x 198
14 x 90 x 198
14 x 90 x 203
14 x 90 x 188
TEX035 14 x 85 x 198
TEX022XT 14 x 85 x 198
15 x 90 x 203
Type of
Dim. / cm
seam
Sewn 14 x 85 x 198
Welded 14 x 85 x 198
Sewn 14 x 90 x 198
Welded 14 x 90 x 198
Welded 14 x 90 x 203
Welded 14 x 90 x 188
Sewn
14 x 85 x 198
Welded 14 x 85 x 198
Welded 15 x 90 x 203
Accessories
Part
Number
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 conformity mark applicable to class I
Medical Devices 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 Mattresses ASS022XT and ASS035.
• UNI 9175
• BS 6807:2006 Clause 9 (Crib5)
• 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 164033.
Hill-Rom S.A.S. meets the ISO 13485 and ISO 9001 standards
164033(10) - EN
Description
Hill-Rom S.A.S.
Z.I. du Talhouet
56330 PLUVIGNER - FRANCE
hillrom.com
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