Qlci2 - Linak Inline LA20 User Manual

20. QLCI2 (MEDLINE CARELINE
®
Usage
• Operation temperature: + 5 °C to + 40 °C
• Storage temperature: - 10 °C to + 50 °C
• Relative humidity: 20% to 80% - non-condensing
• Atmospheric pressure: 700 to 1060 hPa (3000 m)
• Height above sea level: Max . 3000 meters
• Approvals IEC60601-1
ANSI/AAMI ES60601-1
CAN/CSA-22 .2 No 60601-1
EN 45501 / OIML R76
EU type examination according to 2014/31/U
• Compatibility: All OpenBus control boxes
• Flammability rating: UL V0
• Latex free: Yes
Approvals
An OEM application approval according to EN45501
Typically the LINAK Weighing Solution will be classified as a "non-automatic weight" system .
If a LINAK Weighing Solution system is applied to a bed AND classified as such, the system MUST be "first-time" verified and sealed .
The verification and sealing is typically carried out in one of two ways:
1. Verification by the Bed manufacturer himself.
It prescribes that the manufacturer is certified to carry out the verification .
The certification can be obtained through a Notified Body that performs auditing and approval of the procedures and the quality system in the
manufacturing company .
An example from Denmark:
'DS Certificering' is the only Notified Body in Denmark, certified to carry out approvals of quality systems for manufacturing and calibration of 'non-
automatic weight' systems . Within Europe it is however possible to use any other Notified Body from one of the EU member states .
When certified the Bed manufacturer obtains a type approval certificate to prove they are certified to manufacture and calibrate their own "non-
automatic weight" system .
2. Verification by "first-time" verification Bodies.
In Denmark there are three Notified Bodies available for the verification and sealing of the application: Force Technology, Dansk Kalibreringsteknik and
Trescal . Again any other Notified Body from an EU member state can be used . "First-time" verification can take place at either the manufacturer or at
the destination of use .
Requirements in both situations:
• The Type Approval Certificate number MUST be marked at the label on the weight unit .
• The Type Approval Certificate must be issued according to and including reference to the Directive for "non-automatic weights" 2009/23/EC (new non-
modified version of 90/384/EEC) .
)
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Page 262 of 295
The Quad Load Cell Interface 2 (QLCI2) for the
hospital and care segment is a scale system ac-
cessory with weighing capabilities and Out of Bed
functionality .
The housing, makes the QLCI2 easy to mount by
unique slide-on brackets and has an IPX6 Wash-
able DURA ingress protection .
TM
The QLCI2 supports the LINAK OpenBus
offering a high level of customisation .
LINAK A/S delivers the OpenBus™ system only
and is not responsible for any products (i .e . prod-
ucts from 3 party suppliers) other than LINAK
rd
products or the compatibility of such products
with the LINAK OpenBus™ system .
system
TM