Roche ACCU-CHEK Inform II User manual

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.
 •4serialcableswithRJ-25connectorsonbothsides
 •BaseUnitHUB
 •USBcable
 •Powersupply(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:
 •Onlyusethedeviceataroomtemperaturebetween
37°Fand122°F(3°Cand50°C).
 •Useonlymainsvoltageof100Vto240V(±10%),50/60Hz.
 •Useonlythestandard12Vcabledpowersupplyformedical
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
toENISO15197AnnexA.Thesystemalsocomplieswiththe
electrostaticdischarge(ESD)immunityrequirementsasspecied
in IEC 61000-4-2 and complies with applicable electromagnetic
emissions(EMC)requirementsaccordingtoEN61236.The
system’s emissions of the energy used are low and not likely to
cause interference in nearby electronically driven equipment.
ElectrostaticDischarge(ESD)isanelectricalchargeatrest,most
commonlyknownasstaticelectricity.ToavoidESD,donotusethe
meter in a very dry environment, particularly one in which synthetic
materials(e.g.,carpets)arepresentthatmightcausedamaging
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
 •Lightsupred:Powersupplyisconnected,applicationis
starting up
 •Lightsupgreen:Ready
 •Flashesred(oncepersecond):Error
 •Lightsupblue:Congurationmode
BEthernet/RJ45 connector
 Usedforremotecongurationandcommunication
C, F RJ25 connectors
Used for communication and alternative power supply on
both the ACCU-CHEK Inform II Base Unit HUB(C) and
theACCU-CHEKInformIIBaseUnitLight(F).
DUSB
 Usedforlocalconguration
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)andEthernet(B) ports for
connecting the device to a host computer
E, G Power adaptor—Pluginthepowersupplyhere:(E) on
theACCU-CHEKInformIIBaseUnitHUBand(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.
*

11
The Base Unit HUB 2
HRemovable connector cover
 UsedfortheRJ25connector(ACCU-CHEKInformIIBase
UnitLight(s)only)
IMode switch
 Aswitch(USBcongurationswitch),onthebackofthe
ACCU-CHEK Inform II Base Unit HUB and under the
plastic cover, sets the ACCU-CHEK Inform II Base Unit
HUB to one of two different modes of operation.
Position Mode Description
1Conguration The Base Unit HUB acts as a mass
storage device on the USB port.
This method of communication
with the Base Unit HUB includes
writingandreadinglesusinga
mountedlesystem.
2Serial(ICI)
and Ethernet
(POCT1-A)
Communication via Ethernet
-or-
The Base Unit HUB converts meter
communication(IrDA)received
ontheIRwindowoftheBaseUnit
HUB to wired Ethernet.
Note: The Base Unit HUB cannot
handle Serial and Ethernet
conversion simultaneously. Both
communication paths will be
handled one after the other by
means of timeouts.
Note: The position of the switch may be changed while the
ACCU-CHEK Inform II Base Unit HUB is powered.

12
2 The Base Unit HUB
C
B
E
F
H
Base Unit HUB
Back view
Base Unit Light
Back view

The power cord supplied with the ACCU-CHEK Inform II Base Unit
Light can be operated with the power adaptor provided with the
ACCU-CHEK Inform II Base Unit HUB. The power supply can also
be ordered separately.
The power supply and adaptor must be connected to create a
power supply cord. The power supply cord connects to the
ACCU-CHEK Inform II Base Unit HUB and power outlet to create
power and functionality of the system.
Caution: For continued safety and reliability, use only the power
supply provided with your system or ordered from Roche.
1.Connectthepowersupplytothepoweradapter(E). Then
connect the the power cord to the ACCU-CHEK Inform II Base
Unit HUB and the outlet.
2.ConnectanEthernet/RJ-45cabletothebackofthe
ACCU-CHEKInformIIBaseUnitHUB(B)andtoanRJ-45
network outlet.
3.OncetheACCU-CHEKInformIIBaseUnitHUB has power,
connectittoaACCU-CHEKInformIIBaseUnitLight(s):
a.Removetheconnectorcover(H) on the ACCU-CHEK Inform II
BaseUnitLight(s),usingasmallscrewdriverorsimilartool.
b.PlugtheRJ25cable(providedwiththeACCU-CHEKInform
IIBaseUnitHUB)totheRJ25port(F) on the ACCU-CHEK
InformIIBaseUnitLight(s).
c.ConnecttheotherendofthecabletooneoftheRJ25ports
(C) available on the ACCU-CHEK Inform II Base Unit HUB.
Note: Differences between Ethernet or RJ-45 and RJ-25 cables.
• An RJ45 uses 8 wires and 8 contacts for connection in
Ethernet network.
• An RJ25 uses 6 wires using 6 contacts for connection and
cannot be plugged into an RJ-45 port for connectivity.
Power supply
Operating the device
13
The Base Unit HUB 2

14
2 The Base Unit HUB
Caution: Use only the RJ25 cable provided with the ACCU-CHEK
Inform II Base Unit HUB.
TohelptheSystemAdministratorconguretheACCU-CHEK
Inform II Base Unit HUB, technical documentation is provided. This
technical note is stored on the ACCU-CHEK Inform II Base Unit
HUBitselfasaPDFle.Youcanaccessthislebyconnectingthe
ACCU-CHEK Inform II Base Unit HUB (D)toaPCwiththeUSB
cable.
Caution: Use only the USB cable provided with the ACCU-CHEK
Inform II Base Unit HUB.
Note: For the ACCU-CHEK Inform II Base Unit HUB, you should
plug in either a USB cable or an Ethernet cable, but not both at the
same time.
Note: When the ACCU-CHEK Inform II Base Unit Light is
connected to the ACCU-CHEK Inform II Base Unit HUB via an RJ25
cable, remove the power supply connector from the ACCU-CHEK
Inform II Base Unit Light. Power is provided by the ACCU-CHEK
Inform II Base Unit HUB via the RJ25 connection.
Note: Up to four ACCU-CHEK Inform II Base Unit Lights can be
utilized.

15
The Base Unit HUB 2
Always…
 •…handlethedevicecarefully;avoiddroppingorbumpingit
 •…operatethedeviceatanambienttemperaturebetween
37°Fand122°F(3°Cand50°C).
 •…placethedeviceonalevel,stablesurface(suchasatable)
 •…keepthedeviceclean
Never …
 •…spillliquidsonthedevice
 •…immersethedeviceinanyliquid
 •…exposethedevicetoexcessivesourcesofheatfora
prolonged time
 •…storethedeviceindamporhumidconditionswithout
protection
 •…touchthechargingterminalswithmetallicitems,suchasa
paper clip, during operation
Important notes

16
16
The ACCU-CHEK Inform II Base Unit HUB performs a self test at
regularly scheduled intervals. The self test requires that the
ACCU-CHEK Inform II Base Unit HUB software reboot. To avoid
interrupting communication between the meter and ACCU-CHEK
Inform II Base Unit HUB, the software will only self test and
reboot when communication has been idle for at least 10
minutes. The test procedure itself takes about 3 minutes—in this
time no communication between the meter and the host
computerispossible.Duringtheself-testphase,theHUBLED
indicatorturnsfromgreen(ready)tored(notready).After the self
test the ACCU-CHEK Inform II Base Unit HUB will return
automatically backtothecongurationandstateitwasinbefore
theselftestandtheLEDwillturngreen.
As part of the self test, the integrity of the ACCU-CHEK Inform II
Base Unit HUB’s internal memory is checked. In case of a failure, the
LEDashesredandthebasewillstayincongurationmodeeven
ifthemodeswitchissettoadifferentposition;noUSBorEthernet
communication will be possible.
Self test
2 The Base Unit Hub

3
17
Use the following procedure to clean the ACCU-CHEK Inform II
Base Unit HUB:
1. Placethebaseunitonalevelsurfacepriortocleaning.
2. Unplug the ACCU-CHEK Inform II Base Unit HUB.
3. RemoveaCloroxGermicialWipefromitspackaging.Squeeze
the wipe out and blot on a dry paper towel to remove any
excesssolutionfromit.
4. UseaCloroxGermicialWipetocleanbygentlywipingthe
surfaces of the base unit light being careful to remove any
visible soil or organic material. Use additional wipes as
needed.NOTE:Donotwipetheelectricalconnectorsonthe
back of the base unit
5. Drythebaseunitsurfacesthoroughlywithasoftclothor
gauzeaftercleaning.Visuallyverifythatnosolutionisseen
anywhere on the base unit at the completion of cleaning.
NOTICE Ensure the ACCU-CHEK Inform II Base Unit HUB
(includingconnectors)isthoroughlydriedaftercleaning
ordisinfecting.AashingLED(red)ontheACCU-CHEK
Inform II Base Unit HUB indicates a fault condition.
NOTICE DonotspraytheACCU-CHEKInformBaseUnitHUB
directly with solutions as this could cause the solution to
enter the case and damage the electronic components.
CLEANING
Cleaning the
Base Unit HUB

18
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19
Temperature range 37 °Fto122°F(3°Cto50°C).
Position PlacetheACCU-CHEKInformIIBaseUnit
Hubonalevelsurface(suchasatable)
Interfaces Ethernet(TCP/IP)
Height 1.3 in.
Width 6.5 in.
Length 6.5 in.
Weight 28.2oz.
Temperature range 41°Fto104°F(5°Cto40°C).
Relativehumidity 10to85%(noncondensing)
PRODUCT SPECIFICATION
Operating conditions
and technical data
Storage and transport
conditions
4

20
TROUBLESHOOTING
Display/
symptom
Root cause Possible solution
LEDisnoton Not connected to
power supply or
power supply is
defective, the
ACCU-CHEK
Inform II Base Unit
HUB is defective,
or power outlet not
active.
Disconnectandconnect
the power supply again.
Try another outlet.
LEDashes
red
Communication or
congurationerror.
Checktheconguration
and/ortheconnection
totheData
ManagementSystem
(DMS).Contactthe
DMSorITadministrator
of your institution.
If the error persists, call ACCU-CHEK®Customer Care Service
Center at 1-800-440-3638, 24 hours a day, 7 days a week, 365
days a year.
5