SphingoTec Nexus IB10 Instruction manual

022-00088 REV C
Nexus IB10
Quick User Guide v1.0
Disclaimer:
This Quick User Guide refers to CE-IVD
marked products based on the Nexus
IB10 technology. These products are
cered and approved for the Europe-
an Economic Area (EEA) only.
Human diagnosc use of such products
may be subject to local regulaons.
This Quick User Guide does not replace
or substute for the Instrucons for
Use of the respecve products. The
products may only be used for the in-
tended use dened in their respecve
Instrucons for Use.
CONTACT DETAILS/ FIRST LINE SUPPORT

1How to use EQC
Nexus IB10 will detect the EQC
and run test
Press “QC”
Tray opens. Load EQC disc
Nexus IB10 EQC is for tesng a performance check of the Nexus IB10 system.
Performance checks of the system should ideally be carried out once on a daily
basis prior to paent tesng. NO SAMPLE PIPETTING
1.1
1.2
1.3
Press “Run”1.4
1.5
1.6 EQC test takes approximately two
minutes to run and displays/prints
results
Conrm all EQC results show as
“pass”
1.7
If results display “Fail”, clean the
EQC disc with a lint free, dry s-
sue. Repeat the process. If results
sll display “Fail”, contact your
local technical support
1.8
From the Home Screen press
“New Analysis“

How to run a paent sample
on Nexus IB10
Once the tray opens, place the
test disc onto the tray
Ensure paent sample is equili-
brated to room temperature and
gently mixed by inversion. (check
IFU for compable an-coagulant
for the test)
Enter paent ID or oponally scan
barcode with a barcode reader
Nexus IB10 will detect the
product type and run test
Pipee sample onto Test disc
using a precision pipee xed or
adjusted to 500 µL (for details
see next page “how to pipee a
sample“)
Press “New Analysis”
Press “Analysis”
2.3
2.4
2.5
2.6
2.7
2.8
Press “Run”
IB10 sphingotest assay will run
for 20 minutes; results can be
recorded or printed out
2.9
2
2.1
2.2

How to pipee a sample
Using a precision pipee (xed or adjusted to 500 µL), slowly draw sample
into the pipee p, avoiding bubbles
Posioning the tapered pipee p at a 45 degree angle, pierce the X on the
red dot to expose the sample channel inlet on the Test disc
Slowly express the paent sample into the inlet applying minimum but
connuous force on the pipee plunger
Express sample to the First Stop on the pipee.
Do NOT express sample to the second stop; overlling will cause invalid
results
3.1
3.2
3.3
3.4
3

Result interpretaon guide for controls,
EQC and real paent results
Date and me
of measurement
Person who runs
the test
Paent ID or
name
Test type
LOT number of
the test that was
performed
Serial number of
the instrument
Quantave
paent result
Upper or lower
reference limit
Internal control line
of the performed test
Current soware
version on the
instrument
4

How to use external controls
Bring external controls to room
temperature and gently mix well
Select “QC level”
Nexus IB10 Instrument will
detect the product type and run
test
Press “New Analysis”
Using a precision (xed or
adjustable)pipee, pipee 500μL
onto disc
Press “QC”
Tray opens, load test disc and press
“Run“
Press “OK”
Test results display/print in 20
minutes
Refer to the Controls product
insert or reference documentaon
for assigned values and verify
results are within range
5.10
5.9
5.8
5.7
5.65.1
5.2
5.3
5.4
5.5
5

Open the paper lid (pull the lid
upward by the handle)
Unwind a new paper roll so that
the leading edge comes out from
the boom, facing the user
Remove the used roll
Gently insert a new roll into the
receptacle, and conrm that the
paper comes out through the
front of the printer while holding
the leading edge
Close the lid and make sure that
the paper is posioned between
the lid and the front of the printer
How to exchange paper roll
6.1
6.4
6.3
6.2
6.5
6

Key Technical Specicaons
CATEGORY ITEM SPECIFICATIONS
Input/Output
Thermal Paper
(recommended)
HANSOL PAPER 65GSM Paper width (58
mm, 2.36”)
Paper roll size: max. 40 mm (1.57”)
weight 60g
Barcode Scanner
(oponal)
USB-HID (Human Interface Device)
Type 1D Barcode Scanner (rated current
less than 500 mA)
*Model# Hyperion 1300g made by Honey-
well is recommended
Interface
Ethernet 10/100 Base-T
USB Host 2 USB 1.1 ports
USB Client USB 2.0 port
Opcal
Light Source Backlight Unit (BLU) with LED
Detecon CMOS Image Sensor
Memory Capacity Maximum Memory
Capacity
5000 reports for regular tests
Power AC Adapter Input: AC 100 – 240 V, 1.5 A, 50 – 60 Hz
Output: DC 19 V, 4.74 A, 90 W
Operang
Environment
Temperature 15 ˚C – 32 ˚C (59-89,6˚F)
Humidity 0 – 85%
Storage
Environment
Temperature -20 ˚C – 40 ˚C (-4-104˚F)
Humidity 0 – 85%
Dimension 177 mm (W) x 330 mm (D) x 177 mm (H)
7