Roche ACCU-CHEK Inform II Manual de usuario
Operator’s Manual
Base Unit HUB
Inform II
A
CCU-
C
HEK
®
General Information
The contents of this manual, including all graphics and photographs, are the
property of Roche Diagnostics. No part of this document may be reproduced
or transmitted in any form or by any means, electronic or mechanical, for any
purpose, without the express written permission of Roche Diagnostics.
Roche Diagnostics has made every reasonable effort to ensure that all the
information contained in this manual is correct at the time of printing.
However, Roche Diagnostics reserves the right to make any changes necessary
without notice as part of ongoing product development.
The manual is intended for the US Market only.
This manual was created by the Roche Diagnostics Commercial Education
department. Direct questions or concerns regarding the contents of this
document to:
Roche Diagnostics
Commercial Education Department
9115 Hague Road
P.O. Box 50457
Indianapolis, IN 46250-0457
USA
ACCU-CHEK, ACCU-CHEK INFORM, AND COBAS are trademarks of Roche.
All other trademarks are the property of their respective owners.
© 2013, Roche Diagnostics.
US Order Number: 4987-00-0213
Distribution in USA by: Roche Diagnostics, Indianapolis, IN
This operator’s manual is printed in the US.
Additional copies of this document can be obtained by contacting Roche
Diagnostics Customer Focused Fulfillment at 1-800-428-5030. Request the US
order number listed above.
On the packaging, on the back label of the instrument and in the manual you may encounter the
following symbols, shown here with their meaning:
Lot number
For in vitro diagnostic use
This product fulfills the requirements of Directive 98/79/EC on
in vitro diagnostic medical devices.
Catalog number
Please consult instructions for use.
Caution (refer to accompanying documents). Please refer to safety-related
notes in the manual accompanying this instrument.
Manufacturer
Store at
Revision History
Revisions to this document are provided by Roche Diagnostics when necessary. No
part of this document may be reproduced in any form or by any means without prior
written consent.
Publication
Reference Number
Date Revision Purpose
4987-00-0213 February 2013 New document
Table of Contents
1Introduction
Indications for use ...........................................................................................6
Contents of the pack .......................................................................................6
Safety information............................................................................................6
Operating conditions .......................................................................................7
2ACCU-CHEK Inform II Base Unit HUB System
Device elements overview .............................................................................9
Power supply.................................................................................................. 13
Operating the device .................................................................................... 13
Important notes ............................................................................................. 15
Self test............................................................................................................ 16
3Cleaning
Cleaning the Base Unit HUB ....................................................................... 17
4
Operating conditions and technical data................................................. 19
Storage and transport conditions.............................................................. 19
5Troubleshooting.......................................................................................20
6Information about the software license.....................................21
7Warranty.......................................................................................................22
If you need technical help, call ACCU-CHEK®Customer Care Service Center
at 1-800-440-3638, 24 hours a day, 7 days a week, 365 days a year.
1
The ACCU-CHEK®Inform II Base Unit HUB is intended for use as
an accessory to the ACCU-CHEK Inform II System. The
ACCU-CHEK Inform II Base Unit HUB transfers data from the
ACCU-CHEK Inform II Base Unit Light and docked ACCU-CHEK
Inform II meter to a data management system as an aid in
monitoring the effectiveness of glucose control. The ACCU-CHEK
Inform II system is meant for in vitro diagnostic use by healthcare
professionals in clinical settings.
This system is limited to healthcare professional use only.
•4serialcableswithRJ-25connectorsonbothsides
•BaseUnitHUB
•USBcable
•Powersupply(adapter provided separately)
Only trained healthcare professionals may operate the ACCU-CHEK
Inform II system. The system includes the ACCU-CHEK Inform II
Base Unit HUB. The system can include or may include the
ACCU-CHEK Inform II Base Unit or the ACCU-CHEK Inform II
Base Unit Light. Operators must also have received comprehensive
instruction in the operation, quality control and care of the ACCU-
CHEK Inform II system.
Be sure to read the Important Safety Instructions and Additional
Information section in chapter 1 of the ACCU-CHEK Inform II
Operator’s Manual before operating the system for the rst time.
NOTE: The ACCU-CHEK Inform II Base Unit HUB may only be
used in combination with the ACCU-CHEK Inform II Base
Unit Light and not with the ACCU-CHEK Inform II Base
Unit.
INTRODUCTION
Indications for use
Contents of the pack
Safety information
6
7
To ensure that your ACCU-CHEK Inform II Base Unit HUB functions
properly, observe the following guidelines:
•Onlyusethedeviceataroomtemperaturebetween
37°Fand122°F(3°Cand50°C).
•Useonlymainsvoltageof100Vto240V(±10%),50/60Hz.
•Useonlythestandard12Vcabledpowersupplyformedical
use.
Caution: Electromagnetic interference
The ACCU-CHEK Inform II system complies with both the
electromagnetic immunity requirements and radio interference
immunity requirements at the frequency and test levels according
toENISO15197AnnexA.Thesystemalsocomplieswiththe
electrostaticdischarge(ESD)immunityrequirementsasspecied
in IEC 61000-4-2 and complies with applicable electromagnetic
emissions(EMC)requirementsaccordingtoEN61236.The
system’s emissions of the energy used are low and not likely to
cause interference in nearby electronically driven equipment.
ElectrostaticDischarge(ESD)isanelectricalchargeatrest,most
commonlyknownasstaticelectricity.ToavoidESD,donotusethe
meter in a very dry environment, particularly one in which synthetic
materials(e.g.,carpets)arepresentthatmightcausedamaging
static discharges, or near electronic equipment that is a source of
electromagnetic radiation.
Operating conditions
Introduction
1
8
A
C
B
D
E
I
2
FG
H
Base Unit HUB
Front view
Base Unit HUB
Back view
Base Unit Light
Back view
9
ALED
Light indicating the device status.
ACCU-CHEK Inform II Base Unit HUB status display
•Lightsupred:Powersupplyisconnected,applicationis
starting up
•Lightsupgreen:Ready
•Flashesred(oncepersecond):Error
•Lightsupblue:Congurationmode
BEthernet/RJ45 connector
Usedforremotecongurationandcommunication
C, F RJ25 connectors
Used for communication and alternative power supply on
both the ACCU-CHEK Inform II Base Unit HUB(C) and
theACCU-CHEKInformIIBaseUnitLight(F).
DUSB
Usedforlocalconguration
Connection ports
The following connection ports are located on the back
of the ACCU-CHEK Inform II Base Unit HUB and the
ACCU-CHEK Inform II Base Unit Light:
B, D Data ports—USB(D)andEthernet(B) ports for
connecting the device to a host computer
E, G Power adaptor—Pluginthepowersupplyhere:(E) on
theACCU-CHEKInformIIBaseUnitHUBand(G) on the
ACCU-CHEK Inform II Base Unit Light.
NOTE: The ACCU-CHEK Inform II Base Unit Light does
not require a power supply cord when connected to the
ACCU-CHEK Inform II Base Unit HUB.
Device elements
overview
The Base Unit HUB
2
10
2
The Base Unit Hub
10
I
Base Unit HUB
Back view
* Option 3 is not applicable as a communication mode for the
ACCU-CHEK Inform II Base Unit HUB.
*
Otros manuales para ACCU-CHEK Inform II
4
Tabla de contenidos
