Thermo Scientific BRAHMS KRYPTOR compact PLUS User Manual
B·R·A·H·M·S KRYPTOR
compact PLUS
User Manual | Version R08
106172 I SW 7.06.00 I Date 21.02.2018
B·R·A·H·M·S GmbH
B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 2 of 30
Name REF
B.R.A.H.M.S KRYPTOR compact PLUS 106172
B.R.A.H.M.S KRYPTOR compact PLUS Reading Module 106174
B.R.A.H.M.S KRYPTOR compact PLUS Pipetting Module 106173
B.R.A.H.M.S KRYPTOR BUFFER 89970
B.R.A.H.M.S KRYPTOR compact SOLUTION 1 89981
B.R.A.H.M.S KRYPTOR compact SOLUTION 2 89982
B.R.A.H.M.S KRYPTOR compact SOLUTION 3 89983
B.R.A.H.M.S KRYPTOR compact SOLUTION 4 89984
B.R.A.H.M.S KRYPTOR compact DILCUP 89985
B.R.A.H.M.S KRYPTOR compact REACT 89986
B.R.A.H.M.S KRYPTOR compact PLUS:
Instrument and consumables
Content changes versus previous version
• Add new laser labels
• Add UDI, USA: Rx only and cTUVus labels
• Add information about preventive maintenance frequency by service engineer
• Modification of related software version
• Add CE and IVD label on back side
B·R·A·H·M·S GmbH
B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 3 of 30
Labelling ................................................................................................................................................................. 4
Safety Instructions ................................................................................................................................................ 6
Introduction ............................................................................................................................................................ 8
Instrument Components ....................................................................................................................................... 9
Description of the System Status Window ....................................................................................................... 11
Main Menus .......................................................................................................................................................... 12
The Tool Palette ................................................................................................................................................... 13
Work Surface Colour Codes ................................................................................................................................ 14
Sample Carousel .................................................................................................................................................... 14
Reagent Area ......................................................................................................................................................... 15
Reaction Area ........................................................................................................................................................ 16
Dilution Plate .......................................................................................................................................................... 16
B.R.A.H.M.S KRYPTOR compact SOLUTIONS 1 to 4 ........................................................................................... 17
Fluidic System ....................................................................................................................................................... 17
Routine Work ....................................................................................................................................................... 18
Start-up .................................................................................................................................................................. 18
Maintenance ......................................................................................................................................................... 18
Reagent registration .............................................................................................................................................. 19
Reconstitution of reagents .................................................................................................................................... 19
Perform a calibration .............................................................................................................................................. 19
Run controls ........................................................................................................................................................... 20
Run patient samples with barcode ........................................................................................................................ 20
End of day .............................................................................................................................................................. 20
Analytes with Pre-incubation ............................................................................................................................. 21
Important User Information ............................................................................................................................... 23
Barcodes Specifications ...................................................................................................................................... 25
Troubleshooting Guide ....................................................................................................................................... 26
Result Window Messages ..................................................................................................................................... 26
Degraded Mode ..................................................................................................................................................... 28
Contents
B·R·A·H·M·S GmbH
B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 4 of 30
Labelling
Symbol Explanation
Laser, danger to eyes
Location: on fluidic hood,
on barcode readers
Electrical risk
Location: high voltage power supply,
inside electronic boxes
Biohazard
Location: waste bottle plug, wash station,
waste pump, clot detection board
Thermal risk
Location: reaction area entrance
Electrostaticsensitive part
Location: inside electronic boxes
User hazard
Location: on sample and cooling trays
Caution - Class 3B invisible laser
radiation when open.
Avoid exposure to the beam
Location: on reader head shielding
Caution - Class 3B invisible laser
radiation when open and
interlocks defeated.
Avoid exposure to the beam
Location: on side panel, access to the laser
Laser light
Do not stare into the beam.
Class 2 laser product
Location: on fluidic hood
Symbol Explanation
Serial number
of Reading Module
Serial number
of Pipetting Module
Identification
of the machine
Alternative current (AC)
Humidity range
Temperature range
Medical device conforms to
IVD Directive 98/79/EC
Consult instructions for use
Medical device is CE certified
to conform with the
IVD Directive
Date of manufacturing
Name and address of the
Manufacturer
Protective nominal value
(Rating of electrical fuse)
Electric and electronic equipments
have to be selectively collected
under the manufacturer
respons ibility B·R·A·H·M·S GmbH
V~
T 5A
+18 °C
+30 °C
N
20 %
85 %
B·R·A·H·M·S GmbH
B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 5 of 30
Symbol Explanation
Product reference number
of the assembly
Barcode that provides UDI
information according to FDA
regulations
Federal law restricts this device
to sale by or on the order of a
licensed healthcare practitioner
(applicable to USA classification
only)
cTUVus logo
106172
USA: Rx only
Labelling of
B.R.A.H.M.S KRYPTOR compact SOLUTIONS
SGH 05 Corrosion
SGH 07 Exclamation Mark
B·R·A·H·M·S GmbH
B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 6 of 30
The safety instructions of the User Manual allow the
user to avoid injury to persons, material damages and
environmental contamination.
It is mandatory for users of Thermo Scientific™
B.R.A.H.M.S™ KRYPTOR™ compact PLUS to pay
particular attention to SAFETY INSTRUC TIONS written
in the B.R.A.H.M.S KRYPTOR compact PLUS Manual.
Installation of the B.R.A.H.M.S KRYPTOR compact
PLUS can only be performed by a properly trained service engineer. At the time of installation all performance specifications will be verified. Any attempt to
install, repair or modify the instrument by unauthorized
personnel is not allowed.
The system has to be maintained every 6 months by
an authorized and qualified engineer following the
procedures described in the service manual that is
provided only to the qualified engineers.
This in vitro device must only be used by qualified and
trained personnel according to GMP guide lines. Local
health and safety regulations must also be taken into
account.
Reading and interpretation of results must be done by
a qualified user.
B.R.A.H.M.S KRYPTOR compact PLUS must only be used
with materials, equipment and accessories specified in the
B.R.A.H.M.S KRYPTOR compact PLUS Manual.
B.R.A.H.M.S KRYPTOR compact PLUS analyser is a
Class 2 laser product.
Caution: Use of controls or adjustments or performing
any procedures other than those specified herein may
result in hazardous radiation exposure.
Precaution for installation
Indoor use only
Altitude Up to 2000 m
Temperature range 18
…30 °C
Humidity 20-85% (non condensing)
Corrosion Protection against 1N HCl,
1N NaOH, decontamination
solution, bleached reagent
Electrical mains 100-240 V~, mains supply
voltage fluctuations up to
± 10% of the nominal voltage
50-60 Hz
Power 465 VA
Transient overvoltage: category II
Placement Clearance distance:
Behind: 5 cm
Side-left: 10 cm
Side-right: 20 cm
Disconnecting device should be
accessible.
Transport conditions -20
…70 °C
Long term storage 0
…50 °C
Input and output connections
Caution:
On the serial communication ports, connect only a
RS-232 link (Very low safety voltage).
On the USB port, connect only the specific USB cable
provided (Very low safety voltage).
On Waste bottle cap (liquid level and mechanical
sensor), connect only the specific cable provided (Very
low safety voltage).
Electromagnetic compatibility
Changes or modifications not expressly approved by
B·R·A·H·M·S GmbH could void the user’s authority to
operate the equipment.
B·R·A·H·M·S KRYPTOR compact PLUS is compliant
with class B product requirements as defined in IEC
61326-2-6 standard.
B·R·A·H·M·S KRYPTOR compact PLUS complies with
the emission and immunity requirements describ ed
in EN 61326-2-6. The electromagnetic environment
should be evaluated prior to operation of the device.
Do not use this device in close proximity to sources
of strong electromagnetic radiation (e.g. unshielded
intentional RF sources), as these may interfere with
the proper operation.
Electrical security
Do not connect B.R.A.H.M.S KRYPTOR compact PLUS
to a power supply before ensuring that the voltage
setting is correct.
The analyzer can be used with a power supply (mains)
voltage of 100-240 V~ (50-60 Hz). Verify the voltage of
the local power supply (mains) to be used. Always plug
the analyzer into a grounded outlet. Operating tech ni cians and maintenance personnel are urged to follow
sound electrical safety practices at all times.
Although all metal parts of the analyzer are at ground
potential (zero voltage), they should never be touched
with one hand while touching a plumbing fixture, radiator, AC-operated device or other grounded object with
the other.
Before opening the analyzer, remove the power cable
from the power outlet. Do not replace components or
attempt any repairs with the analyzer switched on.
Do not operate the analyzer in an atmosphere contain ing explosive gases since components of the analyzer
could generate sparks.
Avoid spilling fluid on or into the analyzer at any time.
All spills should be wiped up promptly.
If the equipment is used in a manner not specified by
Safety Instructions
B·R·A·H·M·S GmbH
B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 7 of 30
B·R·A·H·M·S GmbH, the protection provided by the
equipment may be impaired.
Biohazardous
When working with human serum, controls and calibrators all accessible parts of the analyzer must be
consi dered as biohazardous. The pipette tip, sample
cassettes, reagent cassettes, carousel drip pan, and
analyzer deck should be routinely disinfected.
Concerning all areas exposed to patient potential
infectious material or to user contact follow the clean ing requirements and use 5% Hypochloride solution
for decontamination. (See B.R.A.H.M.S KRYPTOR compact PLUS Manual, chapter maintenance.)
It is strongly recommended to wear gloves and a
special coat.
Waste
The reagents and the waste must disposed of as
potential infectious laboratory waste according to local
regulations.
Dilution plate, reaction plate
Before disposing of the dilution plate as well as the
reaction plate stick the adhesive cover film with
bio hazard sign on the plate. The adhesive covers are
supplied with the plates.
B.R.A.H.M.S KRYPTOR compact SOLUTIONS 1 to 4
For detailed information read the safety instructions for
use inserts.
Safety data sheets are available at International Product
Support on request.
Laser
Concerning the sample carousel barcode reader (Class
2 laser) and the manual barcode reader do not look at
the laser. Avoid direct eye exposure.
Class 2 lasers are limited to a maximum output power
of 1 milliwatt and the beam must have a wavelength
be tween 400 and 700 nm. A person receiving an eye
exposure from a Class 2 laser beam, either accidentally
or as a result of someone else’s deliberate action (mis use) will be protected from injury by their own natural
aversion response. This is a natural involuntary response that causes the individual to blink and avert their
head thereby terminating the eye exposure. Repeated,
deliberate exposure to the laser beam may not be safe.
The laser inside the instrument (Class 3B laser) emits
an invisible radiation whose characteristics are the following:
Laser Type LTB SRS
Beam Deviation (mrad) 3*3 5*8
Pulse Length (ns) 2.5 <3.5
Max Peak Power (kW) 100 45
Repetition Rate (Hz) 20 20
Class 3B lasers may have sufficient power to cause an
eye injury, both from the direct beam and from reflections. The higher the output power of the device the
greater the risk of injury. Class 3B lasers are therefore
considered hazardous to the eye.
The laser is only accessible by opening the instrument
cover. The instrument cover (side access panel) is
equipp ed with a safety interlock, which stops laser
beam im me dia tely.
For further information see latest version of
B.R.A.H.M.S KRYPTOR compact PLUS Manual and
latest version of B.R.A.H.M.S KRYPTOR instructions for use for reagents and consumables.
B·R·A·H·M·S GmbH
B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 8 of 30
Intended use
B.R.A.H.M.S KRYPTOR compact PLUS is a fully automated system for in vitro diagnostic. B.R.A.H.M.S
KRYPTOR compact is an autoanalyser which can
perform biochemical investigations.
It is used for measurement of patient samples in
random access mode routinely.
B.R.A.H.M.S KRYPTOR compact PLUS is a closed
system and can only operate utilising special reagents
offered by B·R·A·H·M·S GmbH. The system is based
on TRACE technology (Time-Resolved Amplified Cryptate Emission). The system and the reagents are under
con tinuous develop ment by B·R·A·H·M·S GmbH.
TRACE – the unique measuring principle
of B.R.A.H.M.S KRYPTOR compact PLUS
The measurement principle of B.R.A.H.M.S KRYPTOR/
KRYPTOR compact is based on TRACE technology,
which measures the signal that is emitted from an
immuno complex with time delay.
The basis of the TRACE technology is non-radiative
energy transfer from a donor to an acceptor.
The proximity of donor and acceptor when they are
part of an immunocomplex and the spectral overlap
between donor emission and acceptor absorption
spectra on the one hand, intensify the fluorescent
signal of the cryptate and on the other hand they
extend the life span of the acceptor signal, permitting
the measure ment of temporally delayed fluorescence.
Precise measurement of analyte concentration
When the sample is excited with a nitrogen laser at
337 nm, the donor emits a long-life fluorescent signal
in the milli-second range at 620 nm, while the acceptor
generates a short-life signal in the nanosecond-range at
665 nm or 707 nm depending on the type of acceptor.
When the two components are bound in an immunocomplex, both the signal amplifi cation and the prolong ed life span of the acceptor signal occur at 665 nm or
707 nm, so that it can be measured over µ-seconds.
This long-life signal is proportional to the concentration
of the analyte to be measured.
Introduction
Reliable prevention of interference
Non-specific signals are eliminated by the internally
calc ulated ratio of the intensities at these wavelengths
(665/620 or 707/620).
The signal generated by the cryptate at 620 nm serves
as an internal reference and is measured simul t ane ously with the long-life acceptor signal at 665 nm or
707 nm. Interfering influences, e.g. from turbid sera,
are automatically corrected.
Amplification
by energy
transferDonor
Bound
acceptor
Unbound acceptor
Life span of the
bound acceptor
signal / time-resolved
Life span of the
unbound acceptor signal
Unbound acceptor
Immunocomplex
Excitation
of the sample
at 337 nm
Excitation
of the sample
at 337 nm
10 nsec
µsec
Long-life
acceptor signal
at 665 or 707 nm
Time in µsec
Time in nsec
Intensity
Short-life
acceptor signal
at 665 or 707 nm
Intensity
0.5
620 665 λnm
1
Signal relation 665/620 = 1
Fluorescence intensity
Donor
Acceptor
0.5
620 665 λnm
1
Signal relation 665/620 = 1
Fluorescence intensity
Donor
Acceptor
T = 100%
T = 50%
Internal correction of interfering influences
B·R·A·H·M·S GmbH
B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 9 of 30
2
3
4
1
Instrument
Components
presence. Levels of buffer and distilled water are
managed by float switches within the main body of
the instrument. When the bottle becomes red on the
VDU screen, it is possible to refill the bottles without
interruption to the current run. There is no fluid sensor
on these two bottles.
Carousel
The carousel is di vi d ed into 5 posi tions.
Positions 1, 2 and 3
are hybrid locations
which allow to put
reagent or sample
trays. Positions 4
and 5 are dedicated
only for sample trays. When the hood is open, it is
possible to turn the carousel by hand to simplify
access to each position.
3
This instrument has two parts: pipetting module
and reading module.
Pipetting Module
This part comprised a pipetting unit , fluidic system
and carrousel .
Pipetting unit
The pipetting unit consists of a heated tip sample
probe and a wash station. The heated tip uses a
capacitive liquid level detection system to aspirate
all components required to perform the biological
analysis. This includes the sample, diluent and
reagents. After aspirating the sample and reagent
components into the tip, the tip is heated to reaction temperature and acts as a pre-reaction incubator. This ensures that the fluids are at reaction temperature before dispensing in to the reaction area.
At the end of dispense, the tip is washed to avoid
carry-over contamination between samples.
Caution, any fluidic hood opening stops tip motion.
Fluidic system
The fluidic system includes 3 bottles of 5 liters.
One for the PBS wash liquid (BUFFER; order code for
the buffer: B.R.A.H.M.S KRYPTOR BUFFER) used to
wash the tubing system after pipetting. A second
bottle with distilled or deminerialized water used as
liquid system (DISTILLED WATER) by priming before
pipetting and to keep the tubing line in water during
instrument stand by or switch off. A third bottle is
used to collect liquid waste (WASTE). Only the waste
bottle contains a float sensor on the cap to manage
the liquid level and a mechanical sensor for bottle
2
1
2 3
1
Distilled or demineralized
water tank with floating
switch
PBS Tank with floating
switch
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