helena BioSciences C Series User manual

Helena Biosciences Operator Manual:
Helena C-1, Helena C-2, Helena C-4
HL-2-P-3448 Rev. 3 Page 1
Operator Manual
Helena C-Series Family
Helena C-1 • Helena C-2 • Helena C-4
For In-Vitro Diagnostic use
Instrumentation and reagents for human coagulation and haemostasis
Copyright © 2020, Helena Biosciences Europe

Helena Biosciences Operator Manual:
Helena C-1, Helena C-2, Helena C-4
HL-2-P-3448 Rev. 3 Page 2
Updates
Operator Manual Revision Date of Issue Am endments
Rev.1 2019-12 First edition
Rev. 2 2020-06 Minor updates throughout prior to the first distribution of the instrument.
Rev.3 2020-07 Correction to accessories listed on page 9.

Helena Biosciences Operator Manual:
Helena C-1, Helena C-2, Helena C-4
HL-2-P-3448 Rev. 3 Page 3
Copyright Copyright © 2020 by Helena Biosciences Europe; Neither the
Operator's Manual nor any part thereof may be copied, digitally
processed or otherwise transferred without written permission
from Helena Biosciences Europe. The software for Helena
Biosciences Europe products is the intellectual property of Helena
Biosciences Europe, which the company retains all rights to usage
of the software. The purchaser of a Helena C-Series instrument
acquires rights of use for this software
Trademarks Helena C-Series is a trademark of Helena Biosciences Europe. Other
product names used in this Operator's Manual are trademarks of
the respective companies.
Manufacturer Helena Biosciences Europe
Gateshead
Tyne and Wear
NE11 0SD
United Kingdom
Phone: [phone]
Email: [e-mail]
Internet: http://www.helena-biosciences.com
Warranty The Helena C-Series is warranted for a period of one year after
delivery or first installation. It covers any defects in material,
functionality or workmanship. The first installation must be
registered online at www.c-series.com (see chapter “Registration”)
The warranty expires in case of failures caused by
 Accidents, neglected maintenance & service, abuse or misuse.
 Using unauthorised reagents, consumables or spare parts.
 Unauthorised service. Any repair or service must be performed
by authorised persons.

Helena Biosciences Operator Manual:
Helena C-1, Helena C-2, Helena C-4
HL-2-P-3448 Rev. 3 Page 4
1. Introduction ................................................................................................................................7
1.1 Symbols ............................................................................................................................. 7
1.2 Views of the device ........................................................................................................... 8
1.3 Consumables / Accessories ............................................................................................... 9
1.4 Intended use ................................................................................................................... 10
1.4.1 Comparison of the Helena C-Series Family ................................................................ 10
1.4.2 Test Methods .............................................................................................................. 12
1.4.3 Specimen Collection ................................................................................................... 12
1.4.4 Measurement Principle .............................................................................................. 13
1.4.5 Clotting method (PT, aPTT,..) ..................................................................................... 14
1.4.6 Chromogenic Method (Antithrombin): ...................................................................... 14
1.4.7 Immunoturbidometric Method (D-Dimer): ................................................................ 14
1.5 Safety information .......................................................................................................... 15
1.5.1 Safety information for operation ............................................................................... 15
1.5.2 Safety information for materials ................................................................................ 15
1.5.3 Safety information regarding risk of health ............................................................... 16
1.5.4 Safety information for cleaning, maintenance and servicing..................................... 17
1.5.5 Electrical Safety .......................................................................................................... 18
1.5.6 Recycling of the instrument ....................................................................................... 18
2. Installation of the Helena C-Series .......................................................................................... 19
2.1 Scope of delivery ............................................................................................................. 19
2.2 Conditions of operation .................................................................................................. 20
2.3 First Installation .............................................................................................................. 21
2.4 Switching on and off ....................................................................................................... 22
2.5 Display Protection Foil .................................................................................................... 23
2.6 External Thermal Printer ................................................................................................. 23
2.7 External Barcode Scanner ............................................................................................... 23
2.8 TECAM SMART ................................................................................................................ 24
2.9 Registration ..................................................................................................................... 25
3. Operation of the Helena C-Series ............................................................................................ 26
3.1 Homescreen .................................................................................................................... 26
3.2 Input patient identification ............................................................................................. 27
3.3 Test selection .................................................................................................................. 28
3.4 Measurement ................................................................................................................. 29
3.5 System settings ............................................................................................................... 30
3.6 Test Settings .................................................................................................................... 32
3.7 Review results ................................................................................................................. 34
4. Ticket system ........................................................................................................................... 35
5. Service Functions ..................................................................................................................... 37
5.1 System Information ........................................................................................................ 37
5.2 Optic Check ..................................................................................................................... 38
5.3 System report ................................................................................................................. 39
5.4 Adjust temperature ........................................................................................................ 40
5.5 Overview of Mainboard .................................................................................................. 41
5.6 Typical Failures................................................................................................................ 42

Helena Biosciences Operator Manual:
Helena C-1, Helena C-2, Helena C-4
HL-2-P-3448 Rev. 3 Page 5
6. Hidden Functions ..................................................................................................................... 43
6.1 Reset to factory default .................................................................................................. 43
7. Working with TECAM Smart .................................................................................................... 44
8. Cleaning and maintenance ...................................................................................................... 45
8.1 Cleaning .......................................................................................................................... 45
8.2 Decontamination ............................................................................................................ 45
8.3 Regular maintenance ...................................................................................................... 45
9. Appendix .................................................................................................................................. 46
9.1 Technical data ................................................................................................................. 46

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Helena C-1, Helena C-2, Helena C-4
HL-2-P-3448 Rev. 3 Page 6
List of figures
Figure 1: Top view – Helena C-1 ............................................................................................................. 8
Figure 2: Rear view ................................................................................................................................ 8
Figure 3: Side view ................................................................................................................................ 8
Figure 4: Determination of turning point in clotting method ................................................................... 14
Figure 5: System Information ............................................................................................................... 25
Figure 6: Registration of Helena C-series ............................................................................................... 25
Figure 7: Homescreen Helena C-Series .................................................................................................. 26
Figure 8: Input Patient ID ..................................................................................................................... 27
Figure 9: Test selection Helena C-2/C-4. ................................................................................................ 28
Figure 10: Test selection Helena C-1. .................................................................................................... 28
Figure 11: Screen during measurement ................................................................................................ 29
Figure 12: Quickmenu Helena C-Series .................................................................................................. 30
Figure 13: System settings Helena C-2 and Helena C-4. .......................................................................... 31
Figure 14: Test Setting 1 ...................................................................................................................... 32
Figure 15: Test Setting 2 ...................................................................................................................... 33
Figure 16: Review results ..................................................................................................................... 34
Figure 17: QC Report ........................................................................................................................... 34
Figure 18: Ticket System, LOGIN ........................................................................................................... 35
Figure 19: Ticket System, Voucher ........................................................................................................ 35
Figure 20: Ticket System, Input Code .................................................................................................... 36
Figure 21: Ticket System, TECAM SMART .............................................................................................. 36
Figure 22: System Information ............................................................................................................. 37
Figure 23: Optic Check ......................................................................................................................... 38
Figure 24: Mainboard .......................................................................................................................... 41
Figure 25: Welcome Screen and Factory Default .................................................................................... 43
Figure 26: TECAM SMART .................................................................................................................... 44

Helena Biosciences Operator Manual:
Helena C-1, Helena C-2, Helena C-4
HL-2-P-3448 Rev. 3 Page 7
1. INTRODUCTION
This device left the factory in fault-free condition regarding its safety and engineering
functionality. To maintain this condition and ensure risk-free operation, the operator
must comply with the safety warnings and information in this Operator's Manual.
Use the Helena C
-
Series only in compliance with the instructions in this
Operator's Manual. Otherwise, the manufacturer shall exclude the liability
for any damages to the Helena C-Series, patients or operators.
1.1 SYMBOLS
The following standard symbols are used in this manual:
Symbol Meaning Explanation
Courier Info Key on keypad.
CAPS Info Screen message.
Read Indicates important information and tips.
 Info Describes reaction of the Helena C-Series to
operator input.
Warning
Risk of possible health damage or considerable
damage to equipment, if warning is not
heeded.
Danger Potential risk to operating personnel or
equipment due to electric shock.
Biohazard Equipment can be potentially infectious due to
the samples and reagents used.
Laser Radiation Avoid direct eye exposure.
WEEE
Separate collection of electrical and electronic
waste at the end of life, as required by
European legislation

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HL-2-P-3448 Rev. 3 Page 8
1.2 VIEWS OF THE DEVICE
FIGURE 1: TOP VIEW – HELENA C-1
FIGURE 2: REAR VIEW
FIGURE 3: SIDE VIEW
Home Screen
Coloured Touch Display
Complete area is prewarmed to 37°C
1 x Reagent position Ø24mm
2 x Reagent position Ø22mm
(1 position will be stirred on Helena
C-2 and Helena C-4)
2 x Reagent positions Ø13mm
10 x Cuvette incubation positions
(x20 on Helena C-2 and Helena C-4)
1 x Cuvette measurement positions
(x2 for Helena C-2, x4 for Helena C-4)
5V: Power in
PC: LIS or PC
SERVICE: Software update
PRINTER: Serial printer
BARCODE: Handheld barcode scanner (serial)

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HL-2-P-3448 Rev. 3 Page 9
1.3 CONSUMABLES / ACCESSORIES
Helena C-Series products available
REF Product Description
C-1X Helena C-1 1 x single channel semi-automated coagulation analyser
with starter kit.
C-2X Helena C-2 1 x two channel semi-automated coagulation analyser
with starter kit.
C-4X Helena C-4 1 x four channel semi-automated coagulation analyser
with starter kit.
C-101V Single Cuvettes (Voucher) 500 x single use cuvettes with activation card.
AC4302 Stir Bars 4x stirring magnets. Required to mix Thromboplastin L
reagent for PT testing.
AC4300 Reagent Container (22.5mm) 100x plastic containers for holding reagent.
C-104 Reagent Tube (11.0mm) 100x plastic containers for holding reagent.
C-011 Reagent Adapter 22.5 – 24.2mm 1x Reagent adapter Ø 24.5 – 22.5 mm. Helps to place
vials with different sizes.
C-013 Display Protection Foil 1x protection foil, to save glass from scratches. Kit
includes, foil, clean tissues & remover tool.
C-02 TECAM Smart Software A small local LIS and data management software
package.
C-01 Thermal Printer 1x thermal printer, to print results, calibration data or
system information. Supplied with UK power lead and C-
015 interface cable.
C-016 Thermal Printer Paper 5 x rolls of paper for use with C-01
C-014 Barcode Scanner 1x external, handheld CCD-barcode reader. Reads 1D or
QR codes for patient ID and cuvette vouchers.
2503600 Download cable 1x data cable for transfer of information between
analyser and TECAM smart software.
C-015 Interface Cable 1 x Interface cable for Thermal Printer.

Helena Biosciences Operator Manual:
Helena C-1, Helena C-2, Helena C-4
HL-2-P-3448 Rev. 3 Page 10
1.4 INTENDED USE
The Helena C-Series is designed to carry out blood coagulation tests such as PT,
APTT, TT, Fibrinogen, single factor tests, chromogenic and immunoturbidometric
tests (Antithrombin, D-dimer etc.) on human citrated plasma. The instrument
must be used for the intended purposes and good technical condition maintained
as described in this document. It is designed for use in a laboratory or clinical
environment by trained operators. It is not intended for home use.
1.4.1 COMPARISON OF THE HELENA C-SERIES FAMILY
The Helena C-Series includes three different versions, Helena C-1, Helena C-2 and Helena C-4.
Helena C-Series
Helena C-1 Helena C-2 Helena C-4
Reagent and Optic block prewarmed to 37°C
Cuvette prewarm 10x 20x 20x
Reagent prewarm, 24mm 1x 1x 1x
Reagent prewarm, 22mm 2x 2x 2x
Microtubes prewarm 2x 2x 2x
Reagent stirrer No 1x 1x
Printer, RS232 Yes
Barcode Scanner, RS232 External handheld barcode scanner for 1D or QR labels
To read patient-ID and vouchers.
LIS, USB Yes
Firmware Update, USB Yes
Measurement
Optic channels 1 2 4
Optic wavelength 405nm
(UV)
405nm
(UV)
405nm
(UV)
Cuvette, total volume Single, 75µL Single, 75µL Single, 75µL
Global Clotting Assays PT+aPTT+Fib+TT PT+aPTT+Fib+TT PT+aPTT+Fib+TT
Special Clotting Assays - All factors, LA All factors, LA
Chromogenic Assays - AT, PC AT, PC
Latex enhanced Assays D-Dimer D-Dimer D-Dimer

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HL-2-P-3448 Rev. 3 Page 11
Software features
Reagent Dual LOT
manage two different lots for each test No Yes Yes
Test Calibration
LOT, expiry and up to 5 points for each
test
Yes Yes Yes
Reagent Barcode
Input LOT + Expiry Yes Yes Yes
Patient Barcode
Input patient ID by barcode scanner up to
16char
Yes Yes Yes
System Barcode
Input voucher tickets by barcode scanner
or smart device
Yes Yes Yes
Result Database
save recent 100 results onboard No Yes Yes
Double Determination
Run patient twice and display mean value
No Yes Yes
Stopwatch function
count up or down incubation time 1x 2x 4x
Result Identification
Patient ID or sample ID or Auto ID Yes Yes Yes
Real Time Clock Yes Yes Yes
Change language
EN, ESP, ITA, FR, DE, RO, PL, DA, NL, SR,
ET, FI, HR, LV, LT, PT, SE, SK, SI, CS, HU
Yes Yes Yes
Start test at reagent addition
No additional starter pipette required Yes Yes Yes
Visualise Reaction Curve
TECAM Software required Yes Yes Yes
Link to LIS over USB or network/ASTM
TECAM SMART Software required Yes Yes Yes

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HL-2-P-3448 Rev. 3 Page 12
1.4.2 TEST METHODS
The following tests are provided to detect defects of the human coagulation
system, which can be bleeding or thrombosis and the monitoring of anti-
coagulation drugs like Heparin or Warfarin.
1.4.3 SPECIMEN COLLECTION
Type: Human citrated plasma
Collection: Vein puncture, 1:10 mixed sodium citrate 3.2% (0.105M)
Centrifugation: 10min at 1500g
Storage: Max 4h after collection at room temperature
Bilirubin: < 50mg/dl
Haemoglobin: < 9000mg/l
Triglyceride: < 2500g/l
Always confirm specific
specimen preparation and handling conditions for the
test and reagent being used. This information can be found in the product
specific IFU’s or referenced in the Helena C-Series User Guide (HL-2-P-3429).
Test Name Specimen Method Helena C-Series
Helena C-1 Helena C-2 Helena C-4
PT Prothrombin Time plasma clot Yes Yes Yes
APTT Activated Partial
Prothrombin Time
plasma clot Yes Yes Yes
FIB Fibrinogen plasma clot Yes Yes Yes
TT Thrombin Time plasma clot Yes Yes Yes
AT Antithrombin plasma chromogen No Yes Yes
DD D-Dimer plasma immuno Yes Yes Yes
Factors Factors II, V, VII, VIII,
IX, X, XI, XII
plasma clot No Yes Yes
PC Protein C plasma chromogen No Yes Yes
LA-S Lupus Screen plasma clot No Yes Yes
LA-C Lupus Confirm plasma clot No Yes Yes

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HL-2-P-3448 Rev. 3 Page 13
1.4.4 MEASUREMENT PRINCIPLE
The detection of plasma clotting is based on a photometric principle. No mechanical aids
like mixing bars are required. Blood plasma is filled into a cuvette. Special reagents are
added, which initiate the blood coagulation. The cuvette is transmitted by ultraviolet light
during the coagulation process. When the sample starts to clot a change of light absorbance
is measured. The time from measurement start, to change of light (turning point) is called
clotting time and expressed in seconds [s].
The conversion of coagulation time into a specific test unit is one using a linear, hyperbolic,
semi-logarithmic or double-logarithmic interpolation of the stored calibration points. The
current mathematical model is printed out in "TEST SETUP." Values outside the calibration
range are calculated by extrapolation and flagged as " * ".
Unit Info Decimal
places
Maximum
value
s seconds 1 -
% activity 1 250.0
U units 0 29999
INR Int. ratio 2 99.00
R ratio 2 99.00
NR polish ratio 0 250
mg/dl 0 999
g/l 2 99
IE/ml Int. Units 2 99
mg/l 2 999
µg/ml 3 9.000
ng/ml 0 27500
µg/l 0 27500
IU/mL Int. Units 2 99.00
R = clotting time / normal time
NR = 100 *(normal time/clotting time)
INR = Ratio ISI (International Normal Ratio)
IU/mL = IE/mL = International Units (1.00 IU/mL = 100 % activity)

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HL-2-P-3448 Rev. 3 Page 14
1.4.5 CLOTTING METHOD (PT, APTT,..)
FIGURE 4: DETERMINATION OF TURNING POINT IN CLOTTING METHOD
The final reaction in the coagulation cascade is the transformation of fibrinogen
into fibrin catalysed by thrombin. Fibrin formation increases turbidity of the
sample, which is measured by the photometer and stored as the extinction. The
result in seconds is the time from the start of the reaction to the time of half rate
of change (50% point).
1.4.6 CHROMOGENIC METHOD (ANTITHROMBIN):
The change of optical signal is not caused by clot reaction, but by the release of
colour particles (pNA) which causes a yellow colour. The change of colour is
measured at 405nm and expressed as “dE/60sec” and proportional to the
concentration or activity of analyte.
1.4.7 IMMUNOTURBIDOMETRIC METHOD (D-DIMER):
The change of light is caused by Antigen – Antibody reactions, which scatter the
light. The antibodies are linked to latex particles to amplify the optical reaction. The
change of light is proportional to the concentration of antigen, like D-Dimer and
expressed as dE/120sec

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HL-2-P-3448 Rev. 3 Page 15
1.5 SAFETY INFORMATION
1.5.1 SAFETY INFORMATION FOR OPERATION
Use only the cleaning and rinsing liquids approved by the manufacturer. Failure
to do so could result in faulty measurements or malfunctions of the Helena C-
Series. Prevent reagents from leaking into the Analyser. Failure to do so may
result in damage to the instrument and result in expensive maintenance work!
Carry out control measurements at regular intervals to ensure that the analyser
continues to function faultlessly.
If the instrument is used in a manner not specified by the manufacturer, the
warranty could be affected!
Please read the Operation manual in its entirety prior to operation, in order to
ensure a high level of performance and to avoid errors by user.
1.5.2 SAFETY INFORMATION FOR MATERIALS
Use only
Helena Biosciences Europe
approved and
labelled
material like
cuvettes, spare parts or reagents for which the instrument is intended and
validated for.
Consumables like cuvettes or yellow tips are intended as single
-
use items.
Multiple use may result in false results due to contamination. Follow the
guidance set out in the specific product IFU. Incorrect handling may result in
false results.
Do not use materials after their date of expiry. Expired IVD reagents may
cause false results.
Check correct function of manual pipette every year to ensure accurate
results.

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HL-2-P-3448 Rev. 3 Page 16
1.5.3 SAFETY INFORMATION REGARDING RISK OF HEALTH
Bleeding or Thrombosis
Diagnosis and medication of the human coagulation system based on false
results may lead to critical bleeding or thrombosis. For risk reduction it is
essential to follow the suggestions below.
Regarding risks:
Caused by faulty condition of the instrument, reagent or calibration data:
Perform a quality control before running a series of patient samples or after
reconstitution of a vial or after test calibration to eliminate failure of the
instrument, reagent or calibration data.
Caused by imprecise pipetting:
Validate your pipette every year and label it with the last date of validation.
Caused by false assignment of target values:
Run interlaboratory quality control standards.
Caused by purified water:
Use only high purified water to reconstitute controls or reagents. Check
visually that the water is free of any particles.
Caused by expired reagent:
Do not use IVD reagents or other materials after their expiry date.
Infectious Material
Consider all surfaces and materials which might be in contact with plasma or
other biological liquid as potentially contaminated with infectious material.
Avoid contact:
Wear medical infection grade protective gloves for all work involving potential
contact with infectious material and use each pair of gloves only once. Use a
hand disinfectant product, to disinfect your hands after completion of the
work.
Dispose:
Dispose of infectious materials, such as cuvette waste and liquid waste, in
accordance with local regulations.
Hygienic conditions:
The reagents intended for use with this instrument are for in vitro diagnostic
use only – DO NOT INGEST. Wear appropriate personal protective equipment
when handling all reagent components. Refer to the product safety
declaration for each specific reagent being used and the link to appropriate
hazard and precautionary statements where applicable. Any waste materials
must be considered as potentially infectious. Direct contact must be avoided.

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HL-2-P-3448 Rev. 3 Page 17
1.5.4 SAFETY INFORMATION FOR CLEANING, MAINTENANCE AND SERVICING
Authorized service only!
Carry out only the measures listed in this operator’s manual for maintenance,
repair and replacement. Improper manipulation of the device will void the
manufacturer's liability obligations and may make service calls necessary,
including payments which are not covered by warranty. Only authorized
Customer Service personnel may carry out servicing. Only original
replacement parts may be used. Before doing any servicing on the
instrument, it is very important to thoroughly disinfect all possibly
contaminated parts.
Cleaning and decontamination:
Before the instrument is removed from the laboratory for disposal or
servicing, it must be decontaminated. The procedure is described in chapter
“Cleaning and maintenance” and should be performed by authorised well-
trained personnel only, observing all necessary safety precautions.
Cleaning certificate required!
Instruments to be returned must be accompanied by a decontamination
certificate issued by the responsible laboratory manager. If a
decontamination certificate is not supplied, the returning laboratory will be
responsible for charges resulting from non-acceptance of the instrument.
Regard all surfaces and materials which might be in contact with plasma or
other biological liquid as potentially contaminated with infectious material.
Avoid any direct contact with decontaminants or disinfections.

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HL-2-P-3448 Rev. 3 Page 18
1.5.5 ELECTRICAL SAFETY
Precautions:
 Avoid spilling liquids into the system. In case of spilled liquids disconnect
the system from the power supply, then clean and dry all contaminated
parts.
 Remove the power cord before opening the instrument.
 Do not touch any electronic parts during operation.
 Do not operate system without proper connection to grounding.
 Never intentionally interrupt protective ground contacts.
 Never remove housing elements, protective covers or secured structural
elements, since doing so could expose parts carrying electric current.
 Make sure surfaces such as the floor and workbench are not moist while
operating the device.
 Check electrical equipment regularly. Defective leads or socket must be
replaced without delay.
Connection to power:
 The instrument is in compliance with IEC 61010-1 / 61010-2-101 and
classified as a portable instrument, class II. It does not require a safety
connection to electrical earth.
 Ensure the operating voltage setting is correct before connecting the
device to the mains power. Read chapter “installation” about electrical
conditions.
 The power cord must be easily accessible during normal operation.
EMC Statement:
The Helena C-Series is suitable for use in clinical and industrial
establishments. Tested according to standards IEC 61326-1:2013 and IEC
61326-2-6:2013. It is in compliance with the appropriate requirements of
EN 55011 and EN 61000-4 -2,3,4,5,6,8.
The maximum length of cables to external devices like printer, barcode or LIS
must be less than 3m to keep compliance with EMC
1.5.6 RECYCLING OF THE INSTRUMENT
The system must be decontaminated before being transported to an authorised
disposer for electrical waste.
The instrument must be recycled as required by guideline WEEE (2012/19/EU).
As of the 19th February 2007, Helena Biosciences Europe products meet the
European Union Waste Electrical and Electronic Equipment (WEEE) Directive.
When supplied as B2B EEE the producer invokes regulation 12.2 and passes all
WEEE obligations to the end user.

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HL-2-P-3448 Rev. 3 Page 19
2. INSTALLATION OF THE HELENA C-SERIES
2.1 SCOPE OF DELIVERY
Contents of standard delivery package for Helena C-1, Helena C-2 and Helena C-4:
Contents Qty
Helena C-Series Instrument 1
Power Supply Cable with EU, UK & US adaptors 1
Single Cuvettes (x100) 2
Reagent Containers, Ø22.5 mm (x5) 1
Reagent Tubes Ø11 mm (x5) 1
Display Protection Foil 1
Instrument ID Card 1
Instructions For Use statement 1
For items required but not provided see section 1.3.

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HL-2-P-3448 Rev. 3 Page 20
2.2 CONDITIONS OF OPERATION
Ambient conditions:
Operating Temperature
15 to 30 °C
Humidity
< 70% rel. humidity
Elevation above NN
sea level
< 3,000m
Free of dust
Grade 2
Impact resistance
According to IEC/EN 61010
-
1, 8.2.2
Not allowed
Vibrations, direct sun light and direct exposure
to air conditioning.
Electrical conditions:
100-240 VAC, 47 - 63Hz, no earthing required (Class-2)
Electrostatic Discharge (ESD):
No special requirements for ESD protection (shoes etc.)
Storage conditions:
0 - 50°C, max. 12 months in original package.
Transport conditions:
No special conditions required. The general regulations for transport can
be used.
Hygienic conditions:
Validate your hygienic management system according to international
applied Good Laboratory Practice (GLP) or similar quality standard. Any
waste material must be considered as potentially infectious. Direct contact
must be avoided. Protective gloves during operation, service or cleaning
are required.
Device environment:
No special requirements. Instruments are suitable for use in clinical and
industrial establishments.