Ce Marking Application Year; Service Requirements - GE CARESCAPE ONE User Manual

CARESCAPE ONE User Manual DRAFT 26 October 2017
System introduction

CE marking application year

CE marking application year: 2018

Service requirements

Follow the service requirements listed below.
Refer servicing of the equipment to qualified service personnel only. Service
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personnel servicing this product must have an appropriate technical qualification,
or equivalent work experience, and be familiar with the service requirements
described in this manual and in any related service documentation. Service training
for the product is recommended.
Any unauthorized attempt to repair equipment under warranty voids that warranty.
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It is the user's responsibility to report the need for service to GE or to one of their
●
authorized agents.
Failure on the part of the responsible individual, hospital, or institution using this
●
equipment to implement a satisfactory maintenance schedule may cause undue
equipment failure and possible health hazards.
Regular maintenance, irrespective of usage, is essential to ensure that the
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equipment will always be functional when required.
WARNING
CAUTION
54
The characters used in the UDI marking represent specific identifiers.
In the example above:
Device identifier:
(01) = GS1 global trade item number (GTIN) of the device.
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1234567891234 = Global trade item number.
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Production identifiers:
(21) = GS1 application identifier for the serial number of the device.
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SJN14241237HA = Serial number.
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(11) = GS1 application identifier for the manufacturing date of
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the device.
150628= Manufacturing date: year-month-day (YYMMDD).
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Note that for some product types the production identifier can have
other elements instead of the ones listed above:
(10) = GS1 application identifier for the batch or lot number,
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followed by the batch or lot number.
(17) = GS1 application identifier for the expiration date of the
●
device, followed by the expiration date.
Do not perform any service activities on the monitor in the
patient vicinity while a patient is connected to the monitor.
DISPOSAL. At the end of its service life, the product described
in this manual, as well as its accessories, must be disposed of
in compliance with the guidelines regulating the disposal of
each product. If you have any questions concerning disposal
of a product, please contact GE or its representatives.
CARESCAPE ONE 2094480-001