Vario Photometer DP 300 Operating Manual

1
Vario Photometer
DP 300
Operating Manual
Version 5.11 / 5.11 SI
2
Dear customer,
Thank you for selecting Diaglobal’s Vario Photometer and for the confidence you have
placed in us.
The Vario Photometer belongs to a new generation of small mobile instruments which
are being developed by Diaglobal GmbH and are specially designed for on-site analysis.
An automatic operational device check has been additionally integrated with the actual
software version V5.4. The Vario Photometer therewith complies with the requirements
of the regulations of the German Medical Association which came into effect on
15.02.2008 and will be binding from 01.04.2010.
The Vario Photometer can be used to determine 12 clinical-chemical parameters.
The device can be delivered on request, with SI-units (see chapter 9. Technical data,
table measuring ranges)
The kits and accessories which are required to carry out the tests and measurements
are also available from Diaglobal GmbH.
All the best for your work with the new Vario Photometer !
Yours
Diaglobal GmbH
3
Table of contents
Page
1.
General information regarding the Photometer
4
2.
Installation
5
3.
3.1
3.1.1
3.1.2
3.2
Description of the instrument
Power supply
Mains power operation
Network-independent operation
Measuring system
5
6
6
6
6
4.
4.1
4.2
4.3
4.4
Service
Calibration
Maintenance
Disturbances
Disposal
7
7
7
7
7
5.
5.1
5.2
5.3
Required reagents and laboratory accessories
Reagents / parameter list
Control materials
Laboratory aids
7
7
8
8
6.
Internal quality control
9
7.
7.1
7.2
Measuring process
End point measurement
End point measurement, taking the sample’s blank count
and pre-programmed measuring time into account
Multipoint measurement, taking the sample’s blank point
and recognition of the end point into account
Multipoint measurement, taking the sample’s blank point
and calculation of the end point into account
9
9
7.3
7.4
9
10
10
8.
8.1
8.2
8.3
8.4
8.5
Measurement
Switching the instrument on
Self-testing when switching on
Test selection
Switching the instrument off
Integrated operational device checks
11
11
11
11
11
11
9.
Technical data
13
10.
General guidelines and notes
14
11.
Appendix: “Step-by-step measurement”
14ff.
4
1.
General information regarding the Photometer
Device name:
Vario Photometer
Model:
DP 300
Features:
In-vitro diagnostics, measuring instrument for the
determination of selected clinical-chemical
parameters in blood, serum / plasma and liquor.
The Vario Photometer fulfils the basic requirements of Appendix I of Directive
98/79/EC regarding in-vitro diagnostics.
The conformity of the instrument with Directive 98/79/EC is confirmed by the use
of the CE marking.
Manufacturer:
Diaglobal GmbH
Innovationspark Wuhlheide
Köpenicker Str. 325
12555 Berlin
Tel:
+49 - 30 - 65 76 25 97
Fax:
+49 - 30 - 65 76 25 17
E-Mail: info@diaglobal.de
http://www.diaglobal.de
5
2.
Installation
Please observe the following instructions for use:
Insert the rechargeable battery if the instrument is to be used networkindependent or connect the photometer to the power supply unit.
Press the key <ON/ENTER> (Fig. 1) to activate the internal instrument check
which is automatically carried out by the instrument.
Following this, the instrument is immediately ready for measuring.
3.
Description of the instrument
Cuvette shaft
Display
Function keys
Fig. 1
6
3.1.
Power supply
The Vario Photometer can be operated as desired using a power supply, a (9V
block) battery or (model 6F22 or PP3) rechargeable battery.
3.1.1 Mains power operation
The power supply connector plug is connected to the instrument’s socket.
The Vario Photometer is provided with a power supply unit (6-9V=) for operation
at 230 V/50 Hz.
3.1.2 Network-independent operation
Insertion of the rechargeable battery or the normal battery:
Unscrew the knurled screws on the bottom side and remove the cap. Connect
the rechargeable battery or the normal battery using the push-button contact and
insert it. Place the cap back on top and fasten the knurled screws.
The rechargeable battery cannot be charged whilst it is installed. A separate
battery charger is required for this purpose.
Please note:
The Vario Photometer can be operated using a power supply and it is not
necessary to remove the rechargeable battery or the normal battery for this
purpose.
3.2
Measuring system
The optical section is shown in Fig. 2.
Focus
Cuvette
Fig. 2
The light emitted by an LED is first selected by an interference filter IF (HBW ~ 5
nm) in its spectral ranges (520 nm and 546 nm) and then guided concentrated to
the cuvette in the shaft. After it has passed through the cuvette, a broadband
photo sensor converts the light falling onto its sensor surface to current,
proportional to its intensity.
7
4.
Service
4.1
Calibration
The instrument is works calibrated when supplied - it is not necessary for the
customer to calibrate it.
4.2
Maintenance
After the expiration of warranty we recommend regular yearly maintenance of
the instrument.
4.3
Disturbances
If any disturbances or problems occur, simply call us. We can answer most
questions on the telephone. Faulty instruments must be sent to our Berlin
address. We can lend our customers an instrument whilst theirs is being repaired.
4.4
Disposal
We take back instruments free of charge which are no longer needed or cannot
be repaired and dispose of them.
5.
Required reagents and laboratory accessories
5.1
Reagents / parameter list
The following tests can be measured by the Vario Photometer:
Parameter
Sample material
Tests/pack Art. No.
Blood
Serum
Plasma
Lactate
+
-
+
40
LAC 142
Lactate-rapid
+
-
+
40
LAC 342
Glucose
+
+
+
40
GLU 142
Cholesterol
+
+
+
40
CHO 142
HDL-Cholesterol*
+
+
+
20
HDL 321
Triglycerides
+
+
+
40
TRI 142
Haemoglobin
+
-
-
40
HB 142
Haemoglobin (SLS-Method)
+
-
-
40
HB 342
Erythrocytes
+
-
-
40
ERY 142
Haematocrit
+
-
-
40
HCT 142
Urea
-
+
+
40
HST 321
Uric acid
-
+
+
40
HSR 342
Creatinine**
-
+
+
40
KRE 142
Bilirubin
-
+
+
40
BIL 142
Bilirubin for newborn*
+
+
+
40
BIL 142
* Minicentrifuge (Art.-No. DZ 002) required
** Dry block heater (Art.-No. DZ 003) required
8
5.2
Control materials
Art. No.
HEM QS
ERY QS
Haemoglobin control
Reference for monitoring accuracy and precision of the haemoglobin
measurement for normal range
Erythrocytes- und Haematocrit control
Contents
5 x 1 mL
Reference for monitoring accuracy and precision of the haematocrit and
erythrocytes meas. for normal range
5 x 1 mL
GLU QS
Glucose control 100mg/dL
3 x 4 mL
LAC QS
Lactate control set 2mmol/L ; 4mmol/L ; 10mmol/L
3 x 4 mL
BIL QS
Bilirubin control caps
20 caps
DIA QS
5.3
Description
Lyophilizates for accuracy and precision control of the bilirubin meas.
System-Check
Lyophilizates for accuracy and precision control of the system photometer
and reagent
20 caps
Laboratory aids
Art. No.
Description
Contents
LH 001
Blood lancets
500
LH 004
Capillaries 10 µL, with ringmark
250
LH 006
Cuvette rack
1
LH 007
Micropipettor (pipetting aid)
1
LH 009
Cellulose swabs
LH 010
Cellulose swab box
LH 011
Alkohol pads, non-steril
100
LH 012
Latex gloves, size 6-7 small or 7-8 medium
100
LH 020
Capillaries 20µL, heparinized, end-to-end
100
LH 031
Microvettes CB 300
100
LH 034
Safety Lancets Neonatal, pink 1.2 mm
200
LH 035
Safety Lancets Extra, orange 1.8 mm
200
LH 050
Reaction tubes to isolate the plasma
500
LH 055
Pipette tips, 50-1000µL blue
500
LH 060
Capillaries 60µL, heparinized, end-to-end
LH 500
Pipette fix 500µL
1
DZ 002
Minicentrifuge
1
DZ 003
Dry block heater
1
500
1
5 x 20
All reagent kits, control materials and other materials are supplied by Diaglobal
GmbH and can be stored and transported together with the Vario Photometer in a
practical case.
9
6.
Internal quality control
We recommend using the Diaglobal control solutions LAC QS and GLU QS to
check the accuracy of measurements of lactate and glucose.
We recommend using the blood control HEM QS and ERY QS with target value in
the normal concentration area for checking the accuracy of measurements of
haemoglobin, haematocrit and erythrocyte counts.
We recommend using the Diaglobal control caps BIL QS to check the accuracy of
measurements of bilirubin.
We recommend using the Diaglobal control caps DIA QS to check the accuracy
and precision of the system photometer and reagent.
For all other parameters we recommend using the universal control sera from
company Roche, www.roche.de:
Precinorm U Order-No.: 10 171 735 122 (4 x 5 mL) for normal range
Precipath U Order-No.: 10 171 760 122 (4 x 5 mL) for pathological range
7.
Measuring process
7.1
End point measurement
The absorbency after reaching the end point is measured.
It is measured against the reagent’s blank count.
Parameters: Haemoglobin (HB), Haemoglobin-SLS (HB SLS), Erythrocytes (ERY),
Haematocrit (HCT), Uric Acid (UA), HDL Cholesterol (HDL/CHO)
Calculation
Concentration = Absorbance x Factor
The erythrocyte and haematocrit counts are determined using stored reference
curves.
7.2
End point measurement, taking the sample’s blank count and preprogrammed measuring time into account
After measurement of the sample blank count, the colour reaction is started in
the cuvette and the end point absorbency is measured after a preset period has
lapsed.
Parameters: Bilirubin (BIL), Bilirubin for the newborn (BIL N), and Creatinine
(CRE).
Calculation: Concentration = Absorbance x Factor
Measurement time: 2 Minutes
The samples are measured in succession:
Sample 01: Measurement 1 (sample blank value)
Sample 01: Measurement 2 (result)
Sample 02: Measurement 1 (sample blank value)
Sample 02: Measurement 2 (result)
etc.
10
Parameter: UREA (UREA)
Calculation: Concentration = Absorbance x Factor
Measurement time: 10 Minutes
Blanks of the samples are
Sample 01: Measurement
Sample 02: Measurement
Sample 03: Measurement
etc.
measured
1 (sample
1 (sample
1 (sample
in succession:
blank value)
blank value)
blank value)
Results are measured one after another:
Sample 01: Measurement 2 (result)
Sample 02: Measurement 2 (result)
Sample 03: Measurement 2 (result)
etc.
7.3
Multipoint measurement, taking the sample’s blank point and recognition
of the end point into account
After measurement of the sample blank value (= measurement 1), the colour
reaction is started in the cuvette. The reaction process is monitored by the
instrument (= measurement 2). The measuring procedure is stopped as soon as
the end point is reached.
The time needed to reach the end point is temperature-dependent. It is normally
2 - 6 minutes for the lactate test. If temperatures are close to freezing point,
measuring times of up to 20 minutes may result, dependent on the parameters.
Both single measurements and series measurements can be selected.
If single measurements are made, the samples are measured one after another.
For series measurements, all E1 values are measured first.
Parameters: Lactate (LAC), Cholesterol (CHO), Triglycerides (TRI)
Calculation of concentration in plasma = Absorbance Difference x Factor
7.4
Multipoint measurement, taking the sample’s blank point and
calculation of the end point into account
After measurement of the sample blank value (= measurement 1), the colour
reaction is started in the cuvette. The reaction process is monitored by the
instrument. The end point is calculated using several absorbency values recorded
at different times.
Parameters: Glucose (GLU), Lactat-rapid (LAC-rapid)
Measuring times: Glucose 2 minutes
Lactat-rapid 1 minute
11
8.
Measurement
8.1
Switching the instrument on
Press the <ON / ENTER> key
8.2
Self-testing when switching on
A self-testing of the digital and analogue circuit occurs when switching on the
instrument. The operational device check proceeds automatically after the
switching-on. It lasts ca. 5 seconds, after this the device is ready for measuring.
Note:
In case during the testing it should emerge that one of the device functions does
not satisfy the required settings, the following display appears: <SERVICE>
In this case please switch off the instrument.
Please call the Service of Diaglobal GmbH (tel. 0049 / 30 / 6576 2597) or contact
your speciality retailer.
8.3
Test selection
Press the <ON / ENTER> key
Select the desired method using from the menu using the right or left arrow key:
LAC - LAC-rapid - GLU - CHO - HDL/CHO - TRI - HB - HB-SLS - ERY - HCT UREA - UA - CRE - BIL - BIL N - ABS520 - ABS546
Press the right arrow key to mark the respective next test and the left arrow key
to return to the previous test. The test currently selected is shown in the upper
right-hand corner of the display.
Confirm test selection by pressing the <ON / ENTER> key
8.4
Switching the instrument off
To switch the instrument off, press the keys together.
8.5
Integrated operational device checks
Self-testing when switching on
The testing of the device’s digital and analogue circuit occurs automatically
already when switching on the instrument.
Please see chapter 8, point 8.2.
Differential measurements
All measurements are based on differential measurements, i.e. after having
chosen the desired test the instrument requests a reference measurement
with a blank value cuvette. Thus, a reference basis to the measured value is
established so that minor deviations may be compensated.
12
Measurement range controls
The measurement ranges of all measurement results indicated in the
display become verified by an integrated measurement range control. An
error display appears when exceeding the measurement range.
All measurement ranges, which are separately defined for each parameter,
are documented in the respective package inserts as well as in the
operating manual, chapter 9, technical data.
Plausibility controls
When performing multiple point measurements the extinction, which was
measured first, represents the reference basis. The programme tests the
individual measured values for plausibility. In case particular requirements
(e.g. A2 > A1 for rising reactions) are not met, an error message is
displayed.
13
9.
Technical Data
Storage temperature:
- 20°C...70°C
Operating temperature:
0°C...40°C
Dimensions:
200 x 100 x 50 mm
Weight:
450 g
Measuring principle:
Absorption metering with a single-beam (Fig. 2),
choppered operation
Projection:
LED
Spectroscopic apparatus:
Interference filter
Measuring wavelengths:
520 nm / 546 nm
Spectral half-width value:
~ 5 nm
Extraneous light influence:
Negligible
Interface:
V24 (9600, 8, n, 2)
Power supply:
9V battery or rechargeable battery block 6F22
or PP3 optional plug-in power pack
Warm-up time:
0 min
Interference suppression:
According to DIN VDE 0871 and DIN VDE 0875
Measuring ranges:
DP 300
DP 300 SI
Lactate
0.2 - 30 mmol/L
0.2 - 30 mmol/L
Lactate-rapid
0.2 - 20 mmol/L
0.2 - 20 mmol/L
Glucose
20 - 630 mg/dL
1.1 - 35 mmol/L
Cholesterol
20 - 1300 mg/dL
0.5 - 35 mmol/L
HDL-Cholesterol
10 - 200 mg/dL
0.2 - 5 mmol/L
Triglycerides
20 - 2000 mg/dL
0.2 - 23 mmol/L
Haemoglobin
0.0 - 50 g/dL
0.0 - 31 mmol/L
Haemoglobin (SLS-method)
0.0 - 50 g/dL
0.0 - 31 mmol/L
Erythrocytes
1.0 - 10 Mio/µL
1.0 - 10 Mio/µL
Haematocrit
5 - 90 %
5 - 90 %
Urea
5 - 200 mg/dL
0.8 - 35 mmol/L
Uric acid
0.0 - 25 mg/dL
0.0 - 1500 µmol/L
Creatinine
0.0 - 5 mg/dL
0.0 - 440 µmol/L
Bilirubin
0.0 - 50 mg/dL
0.0 - 850 µmol/L
Bilirubin f. newborn
0.0 - 50 mg/dL
0.0 - 850 µmol/L
ABS 520nm
E = 2.500
E = 2.500
ABS 546nm
E = 2.500
E = 2.500
Inaccuracy:
< 0.5 % at E = 1.000
Relative photometric
short-time standard deviation:
< 0.1 %
14
10.
General Guidelines and Notes
EC Directives
1. Directive 98/79/EC on in vitro diagnostic devices
EN / ISO standards
2. EN ISO 9001:1994, Quality Management Systems, Model for quality
assurance in design, development, production, installation and
servicing
3. EN ISO 13485, Medical devices, Requirements for regulatory purposes
4. EN ISO 14971, Medical devices - Application of risk management to
medical devices
5. EN 61010 –1, Safety requirements for electrical equipment for
measurement, control and laboratory use - Part 1: General
requirements
6. EN 61010 -2-101, Safety requirements for electrical equipment for
measurement, control and laboratory use - Part 2-101: Particular
requirements for in vitro diagnostic (IVD) medical equipment
7. EN 61326 –1, Electrical equipment for measurement, control and
laboratory use - EMC requirements - Part 1: General requirements
8. EN 61326-2-6, Electrical equipment for measurement, control and
laboratory use - EMC requirements - Part 2-6: Particular requirements
- In vitro diagnostic (IVD) medical equipment
9. EN 592, Instructions for use for in vitro diagnostic instruments for
professional use
National directives and recommendations (Germany)
10. Guidelines for Quality Assurance of Laboratory Examinations of the
German Medical Association of 24.08.2001
Note on electromagnetical compatibility
a) This photometer meets the requirements of the IEC 61326 series of
standards regarding electromagnetic radiation and interference
immunity.
b) Do not use this unit near to sources of intense electromagnetic
radiation as these may disturb its correct functioning. During the
measurement, a distance of at least 1 m should be kept between an
operative (turned on) mobile telephone and this photometer.
Note on the unit's internal quality control
This unit checks its functionality when it is turned on.
Moreover, it performs electronically controlled individual tests during the
measurement causing an error message when defined conditions are not
met.
11.
Appendix:
“Step-by-step measurement”
Please refer to the illustrations in the how-to manual “Step by Step”
Step by step instructions
Device manual
1. Switch on:
2. Select test:
Press ON/ENTER
Press arrow key until required test
appears
Wait for device check and confirm with
ON/ENTER
3. Confirm required test:
4. Switch on:
Press ON/ENTER
Press both arrow keys at the same time
Note:
If SERVICE appears after the device
check, the device has a fault.
In this case, please contact our customer
service at +49 (0) 30-6576-2597.
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
LAC 142 / LAC 342 / GLU 142 / CHO 142 / TRI 142
Single measurement
1. Insert capillary with
sample into cuvette
M1
Sample 01
insert
LAC
ON
2. Wash out sample with
micropipetter
M1
Sample 02
insert or
ENTER
3. Screw on cap
Turn cuvette upside down
several times
LAC
ON
ENTER
4. Switch on photometer with
ON/ENTER
Wait for device check, confirm
with ON/ENTER
Select the required test,
confirm with ON/ENTER
ENTER
5. Blank adjustment:
Insert cuvette with sample (fig. 3)
into photometer, blank is stored in
memory
6. Replace screw cap against
starter cap
Remove after signal tone
M2
Sample 01
Measuring
LAC
00:30
ON
ENTER
7. Turn cuvette upside down
several times
8. First press ON/ENTER
9. Timing appears
Thereafter insert cuvette in
photometer
Wait for result
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
LAC 142 / CHO 142 / TRI 142
Serial measurement
M1
Sample 01
insert
LAC
ON
ENTER
1. Wash out samples from
capillaries into cuvettes with
micropipetter
2. Screw on cap
Turn cuvette upside down
several times
3. Switch on photometer with
ON/ENTER
Wait for device check, confirm
with ON/ENTER
Select the required test,
confirm with ON/ENTER
M1
Sample 19
insert or
ENTER
LAC
ON
ENTER
4. Blank adjustment:
Insert cuvette with samples (fig. 2)
into photometer, blank is stored in
memory
5. After blank adjustment of
the last cuvette replace all
screw caps against starter
caps
6. Turn cuvettes upside down
several times at the same
time
Ensure correct order of samples !
M2
Sample 01
Measuring
M2
LAC
Sample 19
5.28 mmol/L
LAC
00:30
ON
ON
ENTER
ENTER
7. First press ON/ENTER
Thereafter insert cuvette 1 in
photometer
Timing appears
Wait for result
8. Read the measured value of
cuvette 1, remove cuvette
Insert cuvette 2, read the
measuring value, remove
cuvette
9. Repeat the process until the
measured value of the last cuvette
is displayed
Pay attention to correct assignment and sequence of samples!
etc.
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
HDL 321
Additionally required: Cholesterol-test (CHO 142)
page 1
1. HDL 321
2. HDL 321
3. CHO 142
Insert 60 µL of sample (e-t-e
capillary) into the reaction
tube "R" and mix well
Insert reaction tube „R“ with
capillary into centrifuge
Insert capillary with 10 µL
sample in cuvette
Leave 5 minutes
Continue with CHO 142
Centrifugate 5 minute
M1
Sample 01
insert
CHO
ON
M1
Sample 02
insert or
ENTER
CHO
ON
ENTER
ENTER
4. CHO 142
5. CHO 142
6. CHO 142
Wash out sample with
micropipetter
Blank adjustment:
Screw on cap
Switch on photometer with ON/
ENTER, wait for device check,
confirm with ON / ENTER
Turn cuvette upside down
several times
Select the HDL/CHO, confirm with
ON/ENTER
Insert cuvette with sample (fig. 4)
into photometer, blank is stored in
memory
Remove after signal tone
Start with CHO measurement
M2
Sample 01
Measuring
CHO
00:30
ON
ENTER
7. CHO 142
8. CHO 142
9. CHO 142
Replace screw cap against
CHO 142 starter cap
Turn cuvette upside down
several times
First press ON/ENTER
Thereafter insert cuvette in
photometer
Timing appears
Wait for result
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
HDL 321
Additionally required: Cholesterol-test (CHO 142)
page 2
10. CHO 142
11. HDL 321
12. HDL 321
Cholesterol value is stored in
memory
Remove 500 µL supernatant from
the centrifuged reaction tube
"R" (fig. 2) and transfer it into a
cuvette
Screw on HDL 321 starter cap
CHO cuvette remains in
Photometer
Continue with HDL 321
HDL
HDL
Sample 01
insert
Insert
blank
ON
ON
ENTER
ENTER
13. HDL 321
14. HDL 321
15. HDL 321
Turn cuvette upside down
several times
After 5 minutes waiting time
remove CHO 142 cuvette from
photometer
Blank adjustment:
Wait 5 minutes
HDL measurement is
prompted
Insert non-treated HDL 321
cuvette from package into
photometer, blank is stored in
memory
Remove after signal tone
In regard to serial measurement
Up to 20 samples can be measured
in series.
16. HDL 321
Insert cuvette with sample
(fig. 13) in photometer
Read result
First the measurement of all CHO
142 - samples must be performed as
usual. Thereafter the measurement
of the corresponding HDL 321 samples is carried out.
Pay attention to correct assignment
and sequence of samples!
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
HB 142 / HB 342 / ERY 142 / HCT 142
1. Insert capillary with blood
sample into cuvette
2. Wash out blood with
micropipetter
3. Screw on cap
Turn cuvette upside down
several times
Wait 3 minutes
HB 342: wait 30 seconds
HB-SLS
Zero
HB-SLS
0
Insert
blank
ON
ON
ENTER
4. Switch on photometer with
ON/ENTER
Wait for device check,
confirm with ON/ENTER
Select the required test,
confirm with ON/ENTER
HB-SLS
Sample 01
insert
ON
ENTER
5. Blank adjustment:
Insert non-treated cuvette
from package into
photometer
ENTER
6. Remove cuvette after
signal tone
Blank is stored in memory
HB-SLS
Sample 01
12.6 g/dL
ON
ENTER
7. Insert cuvette with blood
sample (fig. 3) into photometer
In regard to serial
measurement
Read result
After blank setting any number of
additional samples can be
measured
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
HST 321
Additionally required: minicentrifuge
1. Insert 20 µL sample (e-t-e
capillary) into the reaction
tube "R" and mix well
2. Insert reaction tube „R“
with capillary into centrifuge
Centrifugate 1 minute
Hint: Pay attention to an even
load of the centrifuge!
M1
Sample 01
insert
UREA
3. Remove 500 µL
supernatant from the reaction
tube "R" and transfer it into a
cuvette
M1
UREA
Sample 02
insert or
ENTER
ON
ON
ENTER
4. Screw on cap and turn
cuvette upside down several
times
ENTER
5. Switch on photometer with ON/
ENTER
Wait for device check, confirm
with ON/ENTER
Select UREA confirm with ON/
ENTER
M2
Sample 01
Measuring
6. Blank adjustment:
Insert cuvette with sample (fig. 4)
into photometer, blank is stored in
memory
Remove after signal tone
UREA
00:30
ON
ENTER
7. Replace screw cap against
starter cap
Turn cuvette upside down
several times
8. First press ON/ENTER
9. Wait for result
Thereafter insert cuvette in
photometer
Hint
Time (10 minutes) is displayed
Serial measurement up to 20
samples: procedure is similar to
serial measurement of LAC 142
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
HSR 342
1. Insert 100 µL serum/
plasma into cuvette
2. Screw on starter cap from
plastic bottle
3. Turn cuvette upside down
several times
UA 342
UA 342
Sample 01
insert
Insert
blank
ON
ON
ENTER
4. Leave at room
temperature for 10 minutes
5. Switch on photometer with
ON/ENTER
Wait for device check,
confirm with ON/ENTER
Select UA 342
confirm with ON/ENTER
ENTER
6. Blank adjustment:
Insert non-treated cuvette
from package into
photometer, blank is stored in
memory
Remove after signal tone
UA 342
Sample 01
4.52 mg/dL
ON
ENTER
7. After 10 minutes of waiting
time insert cuvette (Fig. 3) into
the device
Read the measured value
In regard to serial
measurement
After blank setting any
number of additional samples
can be measured
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
KRE 121
Example: 6 samples
Additionally required: Thermostat (30 min. preheated)
1. Pipette 1 mL buffer
solution in each cuvette
Close cuvettes
2. Incubate cuvettes 7
minutes in the preheated
thermostat
Note: Work on each cuvette
individually, one after the
other
3. Insert 500 µL sample in
the cuvette and return it
immediately in the
thermostat to avoid cooling
CRE
Sample 01
insert
ON
CRE
00:15
ON
ENTER
4. Incubate cuvette exactly for
1 minute, meanwhile switch on
photometer
Sample 01
Measuring
ENTER
5. Switch on photometer with ON/
ENTER
6. Insert cuvette into
photometer
Wait for device check, confirm with
ON/ENTER
Time (2 minutes) is displayed
Select CRE, confirm with ON/ENTER
CRE
Sample 01
0.95 mg/dL
ON
ENTER
7. Wait for result
8. Read the measured value,
remove cuvette and repeat the
process in the same way with all
other cuvettes, starting from pt 3.
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
BIL 142 / BIL 142 N
Additionally required: minicentrifuge
1. Insert capillary with sample into
cuvette
2. Wash out sample with
micropipetter
BIL 142: 100 µL
3. Screw on cap
Turn cuvette upside down
several times
BIL 142 N: 10 µL
Sample collection for BIL 142 N
see next page
BIL
Sample 01
insert
BIL
Sample 01
ENTER
ON
ON
ENTER
4. Switch on photometer with
ON/ENTER
Wait for device check, confirm
with ON/ENTER
Select BIL or BIL N,
confirm with ON/ENTER
ENTER
5. Blank adjustment:
Insert cuvette with sample (fig. 3)
into photometer, blank is stored in
memory
6. Exchange screw cap
against starter cap
Remove after signal tone
Sample 01
Measuring
BIL
00:30
ON
ENTER
7. Turn cuvette upside down
several times
8. First press ON/ENTER
9. Timing appears
Thereafter insert cuvette in
photometer
Wait for result
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
BIL 142 / BIL 142 N
Sample collection: BIL 142 N
Additionally required: minicentrifuge , microvette
1. Withdraw about 50 µL blood
with microvette from heel
2. Insert microvette in
centrifuge
Close microvette
Zentrifugate 1 minute
Hint: Pay attention to an
even load of the centrifuge!
3. Remove 10 µL plasma
from microvette
Continue on the previous
page fig. 2
Minicentrifuge
Order-No.: DZ 002
Microvette
Order-No.: LH 031
(100 pc. per pack.)
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
DIA QS / BIL QS
Quality assurance
Photometer testing with control caps
1. 20 control caps with
lyophilized control serum
DIA QS: glucose, lactate,
triglycerides, cholesterol, HDLcholesterol, uric acid, bilirubin
2. Screw on control cap on
the cuvette that is to be
tested
Mix well
3. Leave cuvette for 1 minute
The cuvette now contains a
sample of known
concentration
BIL QS: bilirubin, bilirubin for
newborn
GLU
ON
ENTER
4. Switch on photometer with
ON/ENTER
Wait for device check, confirm
with ON/ENTER
5. Blank adjustment:
Insert cuvette with sample
(fig. 3) into photometer,
blank is stored in memory
Select the required test,
confirm with ON/ENTER
Remove after signal tone
7. Turn cuvette upside down
several times
8. Measurement:
6. Replace control cap
against starter cap
First press ON/ENTER, thereafter
insert cuvette into photometer
Wait for result and compare it with the
target value specified in the package
insert
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
Step by step instructions
Parameter Overview
Sample material / Sample number of serial measurement
Sample material
Pos.
Article No.
Parameter
Method
Serial measurement
Blood
Bilirubin
1
BIL 142
Serum
Plasma Liquor
-
+
+
-
+
+
+
-
DPD
Neonat. Bilirubin
not possible
2
CHO 142
Cholesterol
CHOD-PAP
+
+
+
-
up to 20 samples
3
HDL 321
HDL-Cholesterol
CHOD-PAP
+
+
+
-
up to 20 samples
4
CK 321
CK-NAC / blood
UV-test, IFCC mod.
+
+
+
-
up to 6 samples
5
CK 121
CK-NAC / serum
UV-test, IFCC mod.
-
+
+
-
up to 6 samples
6
CRP 321
C-reactive Protein
Immunoturbidimetry
-
+
+
-
up to 20 samples
7
ERY 142
Erythrocytes
Turbidimetric test
+
-
-
-
unlimited
8
GLU 142
Glucose
GOD-PAP
+
+
+
-
not possible
9
GOT 442
GOT / ASAT
UV-test, IFCC 37°C
-
+
+
-
up to 6 samples
10
GPT 442
GPT / ALAT
UV-test, IFCC 37°C
-
+
+
-
up to 6 samples
11
HB 142
Haemoglobin
Cyanmethaemoglobin
+
-
-
-
unlimited
12
HB 342
Haemoglobin-SLS
SLS-method
+
-
-
-
unlimited
13
HCT 142
Haematocrit
Turbidimetric test
+
-
-
-
unlimited
14
HSR 342
Uric acid / serum
Uricase-PAP
-
+
+
-
unlimited
15
HST 321
Urea
Berthelot, mod.
+
+
+
-
up to 20 samples
16
KRE 121
Creatinine
Jaffé, kinetic
-
+
+
-
not possible
17
LAC 142
Lactate
LOD-PAP
+
-
+
+
up to 20 samples
18
LAC 342
Lactate-Rapid
LOD-PAP
+
-
+
+
not possible
19
TRI 142
Triglycerides
GPO-PAP
+
+
+
-
up to 20 samples
Diaglobal GmbH · Köpenicker Straße 325 · 12555 Berlin · +49 (0)30 6576 2597 · info@diaglobal.de · www.diaglobal.de
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