BIO-FLASH Limited Release - Biokit

1st March 2012
312 / 1BF / MKT
BIO-FLASH
Limited Release
Biokit is pleased to announce the Limited Release of the BIO-FLASH system,
together with the first wave of eleven BIO-FLASH reagents in the field of
Infectious Diseases (ID).
This Limited Release is a sign of our confidence in the high quality experience that
this new system can offer to you and your customers. This confidence is not only
subjective, it is also supported by the CE mark registrations granted to all the
components involved in the project (instrument, consumables, reagents, calibrators
and controls).
It is essential for Biokit to carefully monitor these first installations of the system in
selected markets. Together with the partners involved in this launch, we want to
ensure complete understanding of the system and the materials provided to final
customers in order to assure a win–win situation.
We currently have an inventory available for shipping to affiliates and distributors
especially chosen for the Limited Release. In order to guarantee first class supply
in the future, we ask you to continue communicating any sales expectations,
questions or comments that you may have so that we can be ready when the full
release starts in few months. For this reason we encourage you to arrange calls
through your Area Manager to discuss any situations with logistic implications.
All Technical Services and Product Managers trained in our BIO-FLASH ID
courses already have copy of the documents and marketing tools to support the
Limited Release.
BIOKIT S.A.
Can Malé, s/n. 080186 Lliçà d’Amunt
Barcelona, Spain
Tel. +34 93 860 9000
Fax +34 93860 9009
www.biokit.com
“Converting research into real solutions”

Documents and marketing tools available:
1. Biokit video presentation
2. Biokit (Werfen) presentation (PPT)
3. BIO-FLASH video presentation
4. Biokit. Milestones in ID (PPT)
5. BIO-FLASH presentations (PPT)
5.1. Instrument Overview
5.2. ID Reagent Menu
5.3. User Training
5.4. User Maintenance
6. Understanding BIO-FLASH Reaction (PPT)
7. TORC, Hepatis and HIV insert sheets (PDF)
8. Library of Applications (TORC, SEROLOGY and Verification kits)
9. Tutorial: How to install applications (TORC and SEROLOGY –Hep. and HIV-)
10. VERIFICATION CHECK (Excel)
11. Sample volumes (PPT)
12. Reagents presentation and performance summary (Excell)
13. SALESMAN DOSSIER (Word)
14. CAP TODAY June 2010. Automated immunoassay analyzers (PDF)
15. IA-ID Market Description (PPT)
16. BIO-FLASH Marketing Presentation (PPT)
17. ID Market Scenario EDMA (PPT)
18. BIO-FLASH Competitors (PPT)
19. Competitors Menu Study: Diasorin & Biomerieux (PPT)
20. Technical Information TORC and HEP+HIV
20.1. RUBELLA: disease & tech. characteristics of the reagents (PPT)
20.2. TOXOPLASMA: disease & tech. characteristics of the reagents (PPT)
20.3. CMV: disease & tech. characteristics of the reagents (PPT)
20.4. HBV: disease & tech. characteristics of the reagents (PPT)
20.5. HCV: disease & tech. characteristics of the reagent (PPT)
20.6. HIV: disease & tech. characteristics of the reagent (PPT)
21. Informative videos: TORC, Hepatitis and HIV
22. Copy of RGTS CE registration (PPT)
23. BIO-FLASH Brochure & specs (PDF)
24. Biokit Brochure (PDF)
25. BIO-FLASH poster (PDF)
26. MDSS (PDF)
27. BIO-FLASH Service Manual
28. BIO-FLASH. Quick reference guide
29. BIO-FLASH Operator’s Manual
30. Technical bulletins (Word)
31. BIO-FLASH: Part list & Consumables
32. BIO-FLASH: Recommended Spare Part List
33. BIO-FLASH ID: Lockout Specs (Word)
BIOKIT S.A.
Can Malé, s/n. 080186 Lliçà d’Amunt
Barcelona, Spain
Tel. +34 93 860 9000
Fax +34 93860 9009
www.biokit.com
“Converting research into real solutions”

If you have not yet trained your Technical Service and/or Product Manager in the BIO-FLASH ID, let
me take this opportunity to recommend you enrol them as soon as possible in the training courses
scheduled for this year. Remember that in order to maintain the quality of these courses, the number
of places is limited and admission will be by strict order of registration.
Please contact Montse Armengol (montse.armengol@biokit.com) to obtain the registration form.
Yours sincerely,
Ricard Forns
Marketing and Technical Services Director
BIOKIT S.A.
Can Malé, s/n. 080186 Lliçà d’Amunt
Barcelona, Spain
Tel. +34 93 860 9000
Fax +34 93860 9009
www.biokit.com
“Converting research into real solutions”

montse.armengol@biokit.com
Course interest:
Please indicate what specific course you
would like to attend
Course date :
Course location: Biokit – Barcelona
Participant Company
Name of Participant
Last Name
Participant Country
Email address
Cellular phone during
your stay in Spain
Experience level with
Lab instrumentation
Beginner
Intermediate
Advanced
Years of experience
Instruments used
• Training sessions will be conducted in English
• It is recommended that each attendant brings a laptop
• The training administrator will arrange for hotel accommodations when flight confirmation has been provided
• Attendants are financially responsible for hotel accommodations and expenses
INTERESTING ISSUES TO DISCUSS DURING VISIT
COMMENTS

SOFTWARE
Chemiluminescence Analyzer
Intuitive operator interface
Easy-to-follow pictograms for routine tasks
Extremely reduced learning curve
Quick view of the run status in real time
Multiple accesses to database information
Configurable patient report
Levey-Jennings QC charts
Consumption statistics
User-friendly manual, computer based and contextual help
Touch screen interface
INFECTIOUS DISEASES MENU:
Toxo IgG
Toxo IgM
Rubella IgG
Rubella IgM
CMV IgG
CMV IgM
HCV
HIV-1+2
HBsAg
anti-HBc
anti-HBs
Under development
Syphilis
Chagas
HTLV
HIV Ag/Ab
HBeAg
anti-HBe
HSV I IgG
HSV II IgG
HSV IgM
08186 Lliçà d’Amunt - Barcelona - Spain
Tel.: (34-93) 860 90 00 - Fax: (34-93) 860 90 17
E-Mail: biokit@biokit.com www.biokit.com
REGISTERED
FIRM
3100-9669/10/08 ed. 4/2011

only opened by the instrument when the reagent probe is ready
to pipette one of the reagents. The rest of the time it is closed.
This reduces reagent evaporation and dust contamination and,
together with the refrigeration system, provides excellent on board
reagent stability.
Reagent cartridges have a barcode which includes the Master
Calibration Curve, used for calibrating the entire reagent lot. This
Master Calibration Curve together with reagent stability reduces
reagent usage and hands-on operation time.
6 Sample Probe: Used to pipette samples and diluents.
®
The sample probe is equipped with a Clot Detection system based
on pressure differential technology. This ensures accurate sampling
is a fully automated, benchtop, random access and
multiparametric immunoassay system.
and prevents false negative results due to fibrin clots. The needle
also has a Liquid Level Sensor including Crash Detection.
Magnetic particle separation with flash
chemiluminescent detection delivers exceptional
clinical performance, offering immunoassays with
high sensitivity and extremely large dynamic ranges.
SYSTEM DESCRIPTION
1 Safety Covers: The sample and reagent modules are protected
by lockable covers, that increase operation safety and reduce the
effect of the external environment on the instrument, minimizing
2 Cuvette Loader Module: The exclusive cuvette loader system
can contain up to 280 disposable cuvettes organized in 20 columns
with 14 cuvettes per column. These columns are automatically
separated into individual cuvettes and transferred into the
incubator module. The cuvette loader controls the number of
available cuvettes on-board and displays a warning message
when the supply is low. New cuvettes can be added to this module
at any time.
tubes, providing a total capacity of 30 samples on-board.
A variety of primary or aliquot sample tubes, cups and false
bottom tubes can be accommodated in the rack sectors.
The flexibility of the instrument makes it possible to work with
STAT, automated rerun, reflex tests and calculated testing
minimizing operator handling.
The sample rack sectors configuration allows continuous sample
loading, which facilitates workflow efficiency.
The sample probe is coated with a ceramic compound which,
together with the cleaning solution, reduces the carry-over below
0.1 ppm.
7 Reagent Pipettor: Used for aspirating and dispensing
intermediate reagents and the reagent with magnetic particles.
This probe is also coated with a ceramic compound to prevent
carry-over contamination between reagents, and has a Liquid
Level Sensor including Crash Detection.
8 Distributor/Incubator: The distributor module provides slots
the evaporation of samples and reagents and helping to maintain
temperature control. The BIO-FLASH instrument will not operate
if any of the access covers remain open.
3 Sample Module: The sample carrousel is designed to hold up
to 6 rack sectors, each one capable of accommodating 5 sample
4 Reagent Module: Up to 20 reagent cartridges can be held
in the reagent carrousel, which is cooled to 4ºC.
for up to 46 reaction cuvettes, and incubates all the reaction
steps to 37ºC. The distributor’s rotation system ensures a quickchange
of the cuvette position between the cuvette loader,
MagWash station, dispense positions and Luminometer.
The reagent cartridges are carried by the carrousel to designated
locations where the reagent pipettor can operate.
9 Magnetic Wash Station: The MagWash station is an arc-
The reagent module mixes the innermost vial of the cartridge to
ensure homogenization of magnetic particles while the reagent
is aspirated. This ensures exceptional precision in result generation.
shaped array with 8 wash stations located inside the incubator
module. This station carries out the separation of magnetic
particles from other reaction liquids.
5 Reagent Cartridges: The innovative reagent cartridge includes
10 Luminometer: The Luminometer receives the processed
all necessary reagents in four sealed tubes with a piercing cover.
To start using the reagents, simply push the cover, which opens
the tube’s seal. Once this is done, reagent cartridges are ready
to be inserted into the instrument and ready for operation.
samples and activates them with trigger reagents to obtain a
flash chemiluminescent signal. The measurement device is a
photomultiplier tube that translates light into electrical signals.
The reagent cartridge cover also has a mobile system that is

Specifications
Type
Operation modes
Time to first result
Throughput
Samples
Sample loading
Tube type
Sample ID
Capacity
Dilutions
Flash chemiluminescence
Random access & batch mode
STAT function
< 30 minutes
64 tests/hour for typical assays
Continuous loading
Primary tubes of varying sizes;
- Tubes: Outside diameter between 10-16mm, lenght between 75-100mm
- Cup-on-tube and micro cup (1.5 ml)
Positive sample identification with barcode; Code 128, Code 39, Codabar (NW7), Interleave 2 of 5
30 positions
Sample pre-dilution and post-dilution (re-run) available. Reflex tests.
Sampling Probe
Specific reagents
Reaction cuvettes
Washing station
Incubation
Sample volume
Level sense
Cleaning
Carry over
Available Assays
Identification
Storage temperature
On board reagents stability
Cuvettes type
Cuvettes on board
Capacity of washing bottles
Incubation temperature
From 10µl to 200µl (assay dependent)
Capacitance liquid level sensor with clot detection.
Internal and external
< 0.1 ppm
20 on board reagent cartridges
Positive barcode ID
On board refrigerated 4ºC.
> 2 months for typical assays
Disposable cuvettes
280
8 work stations
5 litres
37ºC ± 0.5ºC
Detector
Detector
Emited light
High performance photo multiplier
Isoluminol 420 nm
Calibration
Type
Master curve
Working curve
Calibrators
Master curve by test and lot specific
Up to 12 points, barcoded
Calculated from master curve and 2 calibrators
Barcoded vials
QC
Others
Connectivity requirements
Power consumption
Electrical requirements
Instrument size
Weight
Noise level
Ambient conditions
Working area dimensions
Radiated energy
Electromagnetic compatibility (EMC)
Levey-Jennings charts
Barcoded control vials
ASTM compliant RS-232 or TCP-IP with batch and host query, bi-directional
115VAC at 5.5 amps and 230VAC at 2.75 amps
100-240VAC with electrical variations of up to ± 10% on the nominal supply
and with supply frequencies of 50-60 Hz
Height 50 cm (19.7 inches)
Height with Reagent Cover Open 60 cm (23,6 inches)
Width 84 cm (33 inches)
Depth 61 cm (24 inches)
Aprox. 80 Kg (176 Ibs)
60 dBA mesured from the front (1meter of distance)
Temperature 15ºC - 30ºC
Relative humidity 5% - 85% (non-condensing)
Barometric range 800 - 550 mmHg
Width of table > 51cm (20 inches)
Height of table 92 cm (36 inches)
Lenght of table 150 cm (59 inches)
aprox. 600 WATTS (2.050 BTU per hour)
Class A
08186 Lliçà d’Amunt - Barcelona - Spain. Tel.: (34-93) 860 90 00 - Fax: (34-93) 860 90 17. E-Mail: biokit@biokit.com www.biokit.com

Simple to use
No reagent handling: self-contained, ready-to-use, precalibrated reagent cartridges
Integrated barcode reader for reagent cartridges and samples
Cartridges refrigerated at 4ºC and stable up to more than 2 months onboard
Calibrators & controls barcoded
Easy rack-loading system accommodates up to 30 samples
Windows interface and touchscreen, flat LCD monitor with intuitive prompts
Fast and efficient
Up to 20 reagent cartridges onboard
Available 24 hours/day, 7 days/week
Up to 64 tests/hour
Time to first result: ~ 30 minutes
Random or batch sample processing
Continuous sample loading
Clot detection
STAT function
Highly accurate
Automated chemiluminiscent technology boosts accuracy and sensitivity
Each assay is precalibrated to assure accuracy and standardization
High sensitivity (isoluminol)
No optical interference
Reliability
Automatic reflex testing
Automatic results validation
Westgard multi-rules
Levey-Jennings charts
08186 Lliçà d’Amunt - Barcelona - Spain. Tel.: (34-93) 860 90 00 - Fax: (34-93) 860 90 17. E-Mail: biokit@biokit.com www.biokit.com