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Diaglobal DP 310, Operating Manual

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Diaglobal DP 310 Operating Manual Download Page 10

10 

2021-01 

6.

 

Quality control according to the Guideline of the 
German Medical Association

1)

 

 
The Vario Photometer II has been specially developed for near-patient immediate 
diagnostics  with  unit-use  reagents  (German  Medical  Association,  part  B,  chapter 
2.1.5).  According  to  the  guideline  of  the  German  Medical  Association,  there  is 
therefore  no    obligation  to  participate  in  surveys  (German  Medical  Association, 
part  B,  chapter  2.2,  paragraph  (3)  a).  The  user  only  has  to  carry  out  internal 
quality checks. 
 
Internal  quality  assurance  is  carried  out  in  the  form  of  a  weekly  accuracy  check 
(calibration)  with  subsequent  documentation  of  the  measured  value.  The 
corresponding protocol forms are available from Diaglobal free of charge. 
 
We recommend using the Diaglobal control solutions LAC QS and GLU QS to check 
the accuracy of lactate and glucose determinations

.  

 

We recommend using the blood control HEM QS and ERY QS with target values in 
the  normal  concentration  area  for  checking  the  accuracy  of  determinations  of 
haemoglobin, haematocrit and erythrocyte counts. 
 
For all other parameters we recommend using the universal control sera from the 
company, Roche, www.roche.de: 

PreciControl ClinChem Multi 1 Order-No.: 05 947 626 190 (4 x 5 mL) for normal range 
PreciControl ClinChem Multi 2 Order-No.: 05 947 774 190 (4 x 5 mL) for pathological range 
 

In agreement with the requirements of the German Medical Association, a test of 
the  device  function  (see  operating  instructions,  chapter  8.5)  is  integrated  in  the 
Vario  Photometer  II,  therefor  a  daily  test  by  means  of  a  standard  manual  test 
(German  Medical  Association,  part  B,  chapter  2.1.5,  paragraph  (2)  is  not 
necessary. 
 
The  Vario  Photometer  II  is  suitable  for  the  speedy  detection  of  gestational 
diabetes  and  fulfils  the  requirements  of  the  Maternity  Guidelines

2)

  and  the  S3-

Directive

3)

.  Glucose  can  be  measured  from  whole  blood  as  well  as  from  venous 

plasma. The displayed measured value is - according to the requirements - always 
related to venous plasma. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1)  

Guideline of the German Medical Association for the quality assurance of laboratory medical examinations 

   Deutsches Ärzteblatt | Jg. 116 | Heft 51-52 | 23. Dezember 2019 

2)  

BAnz. Nr. 36, S914 

3)  

AWMF-Register Nr. 057/008 

Summary of Contents for DP 310

Page 1: ...1 2021 01 Vario Photometer II DP 310 Operating Manual Version 5 13 5 13 SI Edition 2021 01 ...

Page 2: ...r an automatic test of the device function has also been integrated Therefore the Vario Photometer II complies with the requirements of the guidelines of the German Medical Association With the Vario Photometer II 13 clinical chemical parameters can be determined The device can be supplied with SI units of measurement on request see chapter 9 Technical Data table Measuring Ranges The kits and acce...

Page 3: ...asurement 11 7 2 End point measurement taking the sample s blank value and pre programmed measuring time into account 11 7 3 Multipoint measurement taking the sample s blank value and recognition of the end point into account 12 7 4 Multipoint measurement taking the sample s blank value and calculation of the end point into account 12 7 5 2 point kinetics fixed time reaction with fixed incubation ...

Page 4: ...ma and cerebrospinal fluid The Vario Photometer fulfils the basic requirements of Appendix I of Directive 98 79 EC regarding in vitro diagnostics The conformity of the device with Directive 98 79 EC is confirmed by the use of the CE marking Manufacturer Diaglobal GmbH Innovationspark Wuhlheide Köpenicker Str 325 Haus 41 12555 Berlin Tel 49 0 30 6576 2597 Fax 49 0 30 6576 2517 E Mail info diaglobal...

Page 5: ...netic waves Operation on a horizontal surface Please observe the following instructions for use Insert a rechargeable battery or normal battery if the device is to be operated independently of a power supply or connect the photometer to a power supply unit Press the ON ENTER key Fig 1 to activate the internal device check which is automatically carried out by the device The device is then immediat...

Page 6: ...compartment cover Connect the battery to the push button contact and insert it into the device Replace the battery compartment cover and screw in the knurled screws Please note The Vario Photometer plus can be operated using a power supply without the need to remove the rechargeable battery or the normal battery The rechargeable battery cannot be charged while it is installed A separate battery ch...

Page 7: ...le decontaminating solutions commonly used in clinical chemistry laboratories such as Mikrozid AF Liquid Bacillol plus 3 Kohrsolin or similar are recommended for cleaning the device and the surface Before cleaning the unit with a soft cloth and the decontaminating solution it must be switched off and the electrical power supply must be disconnected Make sure that no liquids get into the device The...

Page 8: ...lasma CK from blood1 2 3 20 CK 321 CK from serum2 20 CK 121 GOT ASAT2 40 GOT 442 GPT ALAT2 40 GPT 442 Lactate 40 LAC 142 Lactate rapid 40 LAC 342 Urea1 3 20 HST 321 Glucose 40 GLU 142 Triglycerides 40 TRI 142 HDL Cholesterol1 3 20 HDL 321 Cholesterol 40 CHO 142 Creatinine2 20 KRE 121 Haemoglobin SLS method 40 HB 342 Erythrocytes 40 ERY 142 Haematocrit 40 HCT 142 1 Mini centrifuge required Art no D...

Page 9: ...g mark 250 LH 006 Cuvette rack 1 LH 007 Micropipettor pipetting aid 1 LH 009 Cellulose swabs 500 LH 010 Cellulose swab box 1 LH 011 Alcohol pads non sterile 100 LH 012 Powder free nitrile gloves size M 200 LH 020 Capillaries 20 µL heparinised end to end 100 LH 024 Capillaries 20 µL with ring mark 250 LH 035 Safety lancets extra orange 1 8 mm 200 LH 050 Reaction tubes to separate the plasma 500 LH ...

Page 10: ...minations of haemoglobin haematocrit and erythrocyte counts For all other parameters we recommend using the universal control sera from the company Roche www roche de PreciControl ClinChem Multi 1 Order No 05 947 626 190 4 x 5 mL for normal range PreciControl ClinChem Multi 2 Order No 05 947 774 190 4 x 5 mL for pathological range In agreement with the requirements of the German Medical Associatio...

Page 11: ...endpoint absorbance is measured after a specified time has elapsed Parameter Creatinine CRE Calculation Concentration Absorbance x Factor Measuring time 2 minutes The samples are measured one after the other 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 Parameter UREA Calculation Concentration...

Page 12: ... reaction in the cuvette is started The course of the reaction is monitored by the instrument The endpoint is calculated using several absorbance values recorded at different times Parameters Glucose GLU Lactate rapid LAC rapid Measuring times Glucose 2 minutes Lactate rapid 1 minute 7 5 2 point kinetic fixed time interval reaction with fixed incubation time and fixed measuring time T 37 C 7 5 1 C...

Page 13: ...e ON ENTER key After incubation of 5 minutes the first absorbance A1 is measured After another 10 minutes the second absorbance A2 is measured For series measurement the photometer specifies a time interval 15 seconds For series lengths of N 6 the ON ENTER key must be used to switch to the A2 measurement For N 6 the device performs the switchover automatically The measured enzyme activities of the...

Page 14: ...or left arrow key CK 321 CK 121 GOT GPT LAC LAC rapid HST GLU TRI HDL CHO CHO KRE HB SLS ERY HCT ABS365 ABS520 Pressing the right arrow key activates the next test while pressing the left arrow key returns to the previous test The selected test is shown in the upper right corner of the display Confirm test selection with the ON ENTER key 8 4 Switching the device off To switch the device off press ...

Page 15: ...er part of the cuvette where the liquid is with bare hands If this should happen accidentally clean the vials with a fluff free cloth before use Cleaning with a fluff free cloth is recommended in any case Even if the package is still new and unopened Fingerprints on the cuvette lead to incorrect measurement results 3 If blood is taken from the fingertip or earlobe note that the first drop that for...

Page 16: ...omplete transfer of the sample is done by ejecting it several times with the help of the push button on the micropipetter Please note The micropipetter is only used when the capillary is filled with the sample It is not needed for filling the capillary The capillary is filled by the capillary action alone 9 During series measurements make sure that the order of the samples is not reversed Otherwis...

Page 17: ...VDE 0875 Inaccuracy 0 5 at A 1 000 Relative photometric short time standard deviation 0 1 Measuring ranges DP 310 DP 310 SI CK in blood CK 321 0 0 2500 U L 0 0 2500 U L CK in serum CK 121 0 0 2000 U L 0 0 2000 U L GOT ASAT 10 500 U L 10 500 U L GPT ALAT 10 500 U L 10 500 U L Lactate 0 2 30 mmol L 0 2 30 mmol L Lactate rapid 0 2 20 mmol L 0 2 20 mmol L Urea 5 200 mg dL 0 8 35 mmol L Glucose 20 630 ...

Page 18: ...irements 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 23 12 2019 Note on electromagnetic compatibility a The photometer meets the requi...

Page 19: ...ss ON ENTER key Wait for device check and confirm with ON ENTER 2 Select test Press arrow key until required test appears 3 Confirm required test Press ON ENTER 4 Switch off Press both arrow keys at the same time Note If SERVICE appears in the display after the device check the device has a defect In this case please contact our customer service at 49 0 30 6576 2597 ...

Page 20: ...n with ON ENTER key Wait for device check confirm with ON ENTER Select CK 321 confirm with ON ENTER ON ENTER ON ENTER CK 321 CK Measurement START 7 Follow the display insert sample 1 into the photometer Measuring is displayed wait for 10 seconds Then remove the cuvette and incubate it again Proceed in the same way with all other cuvettes in the correct order Then press ON ENTER 8 Time 10 minutes c...

Page 21: ...Switch photometer on with ON ENTER key Wait for device check confirm with ON ENTER Select CK 121 confirm with ON ENTER ON ENTER ON ENTER CK 121 CK Measurement START 8 All measured values can now be displayed one after the other by pressing the right arrow key 6 Follow the display insert sample 1 into the photometer Measuring is displayed wait for 10 seconds Then remove the cuvette and incubate it ...

Page 22: ...or GPT confirm with ON ENTER 6 Note When inserting the cuvette into the photometer make sure that the capillary is positioned at the side of the cuvette wall and aligns with the black arrow on the front foil This ensures that the measurement is not disturbed by the capillary ON ENTER ON ENTER GOT GOT Measurement START 9 All measured values can now be displayed one after the other by pressing the r...

Page 23: ...Zero point adjustment Insert cuvette with sample Fig 3 into photometer zero point is stored in memory Remove cuvette after signal tone 4 Switch photometer on with ON ENTER key Wait for device check confirm with ON ENTER Select the required test confirm with ON ENTER 6 Replace screw cap with starter cap ON ENTER ON ENTER M1 LAC Sample 01 insert 9 Time is displayed wait for measured value 7 Turn cuv...

Page 24: ...lect the required test confirm with ON ENTER 5 After the zero point adjustment of the last cuvette replace all screw caps with starter caps ON ENTER ON ENTER M1 LAC Sample 01 insert 8 Read the measured value of the 1st cuvette remove cuvette Insert 2nd cuvette read the measured value remove cuvette and so on 6 Turn all cuvettes simultaneously upside down repeat several times 7 First press ON ENTER...

Page 25: ... times 6 CHO 142 Zero point adjustment Insert cuvette with sample Fig 4 into photometer zero point is stored in memory Remove cuvette after signal tone 5 CHO 142 Switch photometer on with ON ENTER key wait for device check and confirm with ON ENTER Select HDL CHO confirm with ON ENTER Start with the measurement of CHO 7 CHO 142 Replace screw cap with starter cap of CHO 142 ON ENTER ON ENTER M1 CHO...

Page 26: ...o point adjustment Take an unprocessed HDL 321 cuvette blank from the package and insert it into the photometer Zero point is stored in memory 16 HDL 321 Insert cuvette with sample Fig 13 in photometer Read measured value ON ENTER ON ENTER HDL Insert blank HDL Sample 01 insert 13 HDL 321 Turn cuvette upside down several times Wait for 5 minutes 10 CHO 142 The cholesterol value is stored in memory ...

Page 27: ... point is stored in memory Remove cuvette after signal tone 5 Switch photometer on with ON ENTER key Wait for device check confirm with ON ENTER Select UREA confirm with ON ENTER 7 Replace screw cap with starter cap Turn cuvette upside down several times ON ENTER ON ENTER M1 UREA Sample 01 insert ON ENTER M2 UREA Sample 01 00 30 Measuring M1 UREA Sample 02 insert or ENTER 8 First press ON ENTER Th...

Page 28: ...3 Transfer 500 µL of the sample serum plasma into the cuvette Then insert the cuvette immediately into the dry block thermostat 5 After switching the photometer on wait for device check and confirm with ON ENTER Select CRE confirm with ON ENTER ON ENTER 7 Wait for measured value 2 minutes 6 Insert cuvette into photometer Time is displayed ON ENTER CRE Sample 01 00 15 Measuring CRE Sample 01 insert...

Page 29: ...ro point adjustment Insert an unprocessed cuvette from package into photometer Zero point is stored in memory 4 Switch photometer on with ON ENTER key Wait for device check confirm with ON ENTER Select the required test confirm with ON ENTER In regard to series measurement After zero point setting any number of additional samples can be measured ON ENTER ON ENTER HB SLS Insert blank Zero HB SLS 0 ...

Page 30: ...est you want to check Mix well Now the cuvette contains a sample with a known concentration 3 Leave the cuvette for 1 minute 4 Switch photometer on with ON ENTER key Wait for device check confirm with ON ENTER Select the required test confirm with ON ENTER 6 Replace control cap with starter cap ON ENTER GLU 8 First press ON ENTER then insert cuvette into photometer Wait for measured value Compare ...

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