Operators Manual
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Page 1
Note to the users of the EML105, ABL5xx, ABL SYSTEM 6xx, ABL7xx Series, ABL800 FLEX and ABL800 BASIC analyzers Introduction
This note to users outlines a change in the operator’s and reference manual for your EML105, ABL5xx, ABL SYSTEM 6xx, ABL7xx Series, and/or ABL800 FLEX and ABL800 BASIC analyzer.
Brief overview of the change
Operator’s manual: Limitations of use and known interfering substances: CAUTION - Known interfering substances Substance
Interference –
–
ClO4 (drugs)
For ClO4 , interference on cCa2+ (1.25 mmol/L level) has been detected: cCa2+ (1.25 mmol/L level): 0.20*.
* Depending on the pH level
Reference manual: Change/Description Interference on
–
For ClO4 , interference on cCa2+ (1.25 mmol/L level) has been detected. The interference results for ClO4– are as follows: Interference on…
Substance ClO4– 1.5
Test Conc.
mmol/L
cK+
cNa+
cCa2+
cCl
(4 mmol/L level)
(150 mmol/L level)
(1.25 mmol/L level)
(110 mmol/L level)
-
-
0.20*
8-30
* Depending on the pH level A "-" indicates that interference has not been measured on the respective parameter.
Technical documentation
The manual will be updated with the above information as part of the next manual update.
Instructions to user
Please place this note to the users in the binder of your manual.
© 2009 Radiometer Medical ApS. All Rights Reserved. 995-521. 200912A.
Note to users of the ABL700 Series analyzers, from software version 3.836 Mandatory upgrade of the manual
The manuals for the ABL700 Series analyzers, from software version 3.836, must be upgraded with regard to the information on cleaning solution. The procedure for adding cleaning additive has been changed for the abovementioned analyzers and from now on the following instructions must be followed:
Cleaning solution with cleaning additive installation
1.
Remove the foil from the DosiCapZip and unscrew it (Figs. 1+2).
2.
Turn the DosiCapZip upside down and screw it onto the container again (Figs. 3+4). CAUTION: If the contents of the DosiCapZip or the container have been spilt by accident, both the container and the DosiCapZip should be discarded to prevent incorrect concentrations in the solution. T
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3.
Invert the container at least 20 times to dissolve the additive (Fig. 5).
4.
Place the container horizontally so that the solution may enter the DosiCapZip and leave it for 3 minutes (Fig. 6).
5.
Invert the container again at least 20 times to fully dissolve the additive (Fig. 7).
6.
Unscrew the lid from the new solution container.
7.
Remove the used solution container by holding it on the sides and pulling.
8.
Scan the barcode of the new solution, using the barcode reader.
9.
Place the new solution container in position on the analyzer and push it firmly onto the connector as far as possible.
10.
Press Restart to restart the analyzer.
© Radiometer Medical ApS, 2700 Brønshøj, Denmark, 2008. All Rights Reserved. 994-590. 200810A.
Cleaning solution with cleaning additive – general information
T
Item Cleaning Solution 175 mL
Code No. 944-123
Type S7375
Use: For cleaning the measuring system of the ABL700 Series analyzers. Contains: Salts, buffer, anticoagulant, preservatives, surfactants and enzyme. Safety Data Sheet may be obtained from your local distributor. Storage: At 2-10 °C. Stability in use: The Cleaning Solution with the Cleaning Additive is stable for 2 months in use. Analyzer: Perform cleaning every 8th hour. CAUTION – Risk of personal injury Do not breathe dust (S22). Avoid contact with skin (S24). Irritating to eyes and skin (R36/38). Wear suitable gloves (S37). May cause sensitization by inhalation and skin contact (R42/43). In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible) (S45). T
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Texts no longer valid in the manuals
Due to new cleaning solutions, information about Cleaning solution S7370 and Cleaning additive S5370 is no longer valid. Below is a list of the sections in the manual that must be ignored. ABL700 operator's manual, from software version 3.836: Chapter 1: Introduction: Warning/Cautions and Notes:
"Cleaning Additive May cause sensitisation by inhalation and skin contact. Do not breathe dust. Avoid contact with skin. Wear suitable gloves. In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)." Warning no longer relevant. T
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Chapter 2: What is What: Main Components - Front:
Cleaning Solution S7370: S7370 is no longer valid. Use S7375 instead.
Chapter 4: Analyzer Menus and Programs: Starting the Analyzer After Long-Term Shutdown, Items Required:
S7370 is no longer valid. Use S7375 instead.
Chapter 12: Troubleshooting: Fluid Transport Troubleshooting Procedure:
Text about Cleaning Additive no longer relevant. Follow the new procedure above instead.
Chapter 14: Specifications and Accessories: Accessories and Ordering Information, ABL700 Series Solutions:
Text about Cleaning Solution S7370 no longer relevant. Use new Cleaning Solution, S7375, code no: 944-123 instead.
Accessories and Ordering Information, Other Accessories:
Text about Cleaning Additive no longer relevant
Index:
Cleaning Additive references no longer relevant.
Technical documentation
The manual for the ABL700 Series analyzers will be updated with the above information when reprinted.
Instructions to user
This update kit includes a note to the user with the changes and a new date of issue page of the manual. Please place the note to the user in the binder of the ABL700 Series manual and replace the date of issue page with the new corresponding page, then discard the old page.
Note to the users of the ABL700 Series analyzers, from software version 3.836 Introduction
This note to users outlines a change in the manual for your ABL700 Series analyzer, software version 3.836.
Brief overview of the change
Recommended Replacement Intervals The following table lists the part replacement intervals as recommended by Radiometer. NOTE: The replacement intervals below are guidelines only and based on the average use of the analyzer (40 samples per day); under no circumstances do they guarantee the lifetime of the replacement items. For analyzers with high throughput, the replacement intervals should be adjusted accordingly in the Replacement schedule. Action Interval Replacing metabolite and reference electrode membranes
1 month
Replacing blood gas and electrolyte electrode membranes
3 months
Replacing pump tubing
6 months
Replacing inlet gasket
6 months
Replacing fan filter
as required
Replacing electrodes
as required
Replacement of items such as solutions, waste container, gas containers and printer paper, are not scheduled and are to be replaced as required. Their status can be viewed on the Replacement Status screen. Technical documentation
The manuals will be updated with the above information as part of the next manual update.
Instructions to user
Please place this note to the users in the binder of your manual
© 2009 Radiometer Medical ApS. All Rights Reserved. 995-565. 200912A.
Table of Contents
ABL700 Series
Operator’s Manual
1.
Introduction
2.
What is What
3.
Touch Screen Elements
4.
Analyzer Menus and Programs
5.
Setup Programs
6.
Patient Samples
7.
Quality Control
8.
Calibration
9.
Replacement of System Components
10. Disk Functions
11. Data Logs
12. Troubleshooting
13. Sampling Procedures
14. Specifications and Accessories
15. Appendix
Index - Date of Issue
System performance The procedures described in this manual must be observed in order to ensure proper system performance, and to avoid hazards. Radiometer cannot provide or verify system performance characteristics if the system is not installed, used and maintained in accordance with Radiometer procedures or if accessories not meeting the specifications provided by Radiometer are used. Radiometer warrants that the data media on which the software included in the system is furnished is free from defects in material and workmanship under normal use for three (3) months from the date of delivery as evidenced by a copy of invoice or receipt. Third-party software and trademarks The ABL700 Series analyzers comprise the Microsoft® Windows®95, VxWorks® and Sybase® SQL Anywhere® software. By using the system, you accept the terms of the Software License Agreement(s) of the provider(s) of the above software as shown in the End User License Agreement(s) in the analyzer start up picture and to the terms of the Microsoft®Windows®95 End-User Agreement included in this manual. If you cannot accept the terms of the Software License Agreement(s), you should not use the system, but immediately contact your provider for a return of the system and a refund of the purchase price. Microsoft® and Windows® are trademarks of Microsoft Corporation. VxWorks® is a registered trademark of WindRiver Systems Incorporated. Sybase® SQL Anywhere® is a registered trademark of Sybase Incorporated. Warranties and disclaimer Radiometer makes no warranties, express or implied, other than expressly stated. Any warranties expressly stated in this document are conditional upon the system being installed, used and maintained in accordance with Radiometer procedures, including that only accessories meeting the specifications provided by Radiometer are used. Radiometer disclaims any liability for system performance if the system is not installed, used and maintained in accordance with Radiometer procedures or if accessories not meeting the specifications provided by Radiometer are used. Further, Radiometer disclaims any liability for loss of data and direct, consequential or other damages, including loss of profit or loss of business, whether such claim for damages is based upon contract, negligence or tort (including strict liability), and even if Radiometer has knowledge of the possibility of the potential damage or loss.
Confidentiality The contents of this document shall not be reproduced or communicated to any third party without the prior written consent of Radiometer.
Changes This document is subject to change without notice and you are urged to contact Radiometer to verify whether the document has been changed. While every effort is made to ensure the correctness of the information provided in this document as changed from time to time, Radiometer disclaims any liability for errors and omissions.
Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, PICO and CLINITUBES are trademarks of Radiometer Medical ApS. © 2008 Radiometer Medical ApS. All rights reserved.
End User License Agreement for the ABL700 Series Analyzers T
You have acquired a device ("DEVICE") THAT INCLUDES SOFTWARE LICENSED BY Radiometer Medical ApS from Microsoft Licensing Inc. or its affiliates ("MS"). Those installed software products of MS origin, as well as associated media, printed materials, and "online" or electronic documentation ("SOFTWARE") are protected by international intellectual property laws and treaties. The SOFTWARE is licensed, not sold. All rights reserved. IF YOU DO NOT AGREE TO THIS END USER LICENSE AGREEMENT ("EULA"), DO NOT USE THE DEVICE OR COPY THE SOFTWARE . INSTEAD, PROMPTLY CONTACT THE SUPPLIER OF THE INSTRUMENT FOR INSTRUCTIONS ON RETURN OF THE UNUSED DEVICE(S) FOR A REFUND. ANY USE OF THE SOFTWARE, INCLUDING BUT NOT LIMITED TO USE ON THE DEVICE WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA (OR RATIFICATION OF ANY PREVIOUS CONSENT). GRANT ON SOFTWARE LICENSE. This EULA grants you the following license: • You may use the SOFTWARE only on the DEVICE. • NOT FAULT TOLERANT. THE SOFTWARE IS NOT FAULT TOLERANT. RADIOMETER MEDICAL ApS HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE, AND MS HAS RELIED UPON RADIOMETER MEDICAL ApS TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR SUCH USE. • NO WARRANTIES FOR THE SOFTWARE. THE SOFTWARE is provided "AS IS" and with all faults. THE ENTIRE RISK AS TO SATISFACTORY QUALITY, PERFORMANCE, ACCURACY, AND EFFORT (INCLUDING LACK OF NEGLIGENCE) IS WITH YOU. ALSO, THERE IS NO WARRANTY AGAINST INTERFERENCE WITH YOUR ENJOYMENT OF THE SOFTWARE OR AGAINST INFRINGEMENT. IF YOU HAVE RECEIVED ANY WARRANTIES REGARDING THE DEVICE OR THE SOFTWARE, THOSE WARRANTIES DO NOT ORGINATE FROM, AND ARE NOT BINDING ON, MS. • Note on Java Support. The SOFTWARE may contain support for programs written in Java. Java technology is not fault tolerant and is not designed, manufactured, or intended for use or resale as online control equipment in hazardous environments requiring fail-safe performance, such as in the operation of nuclear facilities, aircraft, navigation or communication systems, air traffic control, direct life support machines, or weapons systems, in which the failure of Java could lead directly to death, personal injury, or severe physical or environmental damage. Sun Microsystems, Inc. has contractually obligated MS to make this disclaimer. • No Liability for Certain Damages. EXCEPT AS PROHIBITED BY LAW, MS SHALL HAVE NO LIABILITY FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISNG FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE SOFTWARE. THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE. IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN EXCESS OF US. TWO HUNDRED FIFTY DOLLARS (U.S.$250.00). • Limitations on Reverse Engineering, Decompilation and Disassembly. You may not reverse engineering, decompile, or disassemble the SOFTWARE, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation. • SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS. You may permanently transfer rights under this EULA only as a part of a permanent sale or transfer of the DEVICE, and only if the recipient agrees to this EULA. If the SOFTWARE is an upgrade, any transfer must also include all prior versions of the SOFTWARE. • EXPORT RESTRICTIONS. You acknowledge that SOFTWARE is of US-origin. You agree to comply with all applicable international and national laws that apply to the SOFTWARE, including the U.S. Export Administration Regulations, as well as end-user, end-user and country destination restrictions issued by U.S. and other governments. For additional information on exporting the SOFTWARE, see http://www.microsoft.com/exporting/.
Contents This manual contains the following topics: Contents ...1 TU
UT
1. Introduction ... 1-1 Names and Intended Use... 1-2 Limitations of Use... 1-6 Known Interfering Substances ... 1-7 Warning/Cautions and Notes ... 1-9 2. What Is What – ABL700 Series Analyzer ... 2-1 Main Components - Front... 2-2 Main Components - Rear ... 2-4 Measuring Section ... 2-5 Inlet Module... 2-7 Thermal Printer ... 2-8 Communication Ports... 2-9 Bar Code Reader ... 2-10 The AutoCheck Carousel... 2-11 3. Touch Screen Elements ... 3-1 Main Display... 3-2 Top Section Elements ... 3-3 Center Section Elements ... 3-6 Bottom Section Elements... 3-10 Screen Navigation via External Keyboard... 3-12 4. Analyzer Menus and Programs... 4-1 ABL700 Series Menu Structure... 4-2 The Main Menu and Status Indicators ... 4-3 Analyzer Tasks... 4-5 Tutorials ... 4-7 Online Help... 4-8 Auxiliary Programs... 4-10 Utilities Programs ... 4-13 Installation ... 4-17 Power Down Program and Restarting the Analyzer ... 4-18 Long-Term Shutdown... 4-20 Starting the Analyzer After Long-Term Shutdown ... 4-22 Selecting Default Settings... 4-23
Contents
ABL700 Series Operator’s Manual
5. Setup Programs... 5-1 General Information... 5-2 Analysis Setup Programs ... 5-5 Patient Report Setup ... 5-15 Calibration Setup Programs ... 5-23 Quality Control Setup Programs... 5-26 Replacement Setup Programs ... 5-42 Parameters and Input Programs ... 5-49 Analyzer Settings ... 5-56 Operators and Passwords ... 5-60 Corrective Actions ... 5-65 Printers Programs... 5-68 Disk Functions Setup Programs... 5-71 Miscellaneous Setup ... 5-74 Communication Setup Programs ... 5-77 Set Language Program... 5-85 6. Patient Samples... 6-1 General Information... 6-2 Syringe Samples... 6-6 Expired Air Samples ... 6-8 Capillary Samples ... 6-9 Patient Identification... 6-12 Selecting Parameters ... 6-17 Patient Result ... 6-18 _
Calculation of FShunt and ctO2(a- V )... 6-24 B
B
Patient Result Messages... 6-25 7. Quality Control ... 7-1 General Information... 7-2 Quality Control Measurement... 7-5 AutoCheck Measurement... 7-8 Quality Control Identification... 7-10 Quality Control Results... 7-12 Quality Control Status ... 7-16 Quality Control Result Messages... 7-18
2
ABL700 Series Operator’s Manual
Contents
8. Calibration ... 8-1 General Information... 8-2 Calibration Process and Result ... 8-4 Calibration Status... 8-6 Unscheduled Calibrations ... 8-8 Interrupted, Pending or Expired Calibrations ... 8-9 tHb Calibration ... 8-10 Calibration Result Messages... 8-13 9. Replacement of System Components ... 9-1 Replacement Status and Conditions... 9-2 AutoCheck Status and Carousel Packing... 9-5 Replacements in the Ready Mode... 9-7 Replacements in the Replacement Mode ... 9-10 Replacements in the Hold Mode... 9-13 Replacing a Membrane or Electrode... 9-16 Replacing the Pump Tubes ... 9-19 Replacing the Inlet Gasket Unit and the Probe ... 9-22 10. Disk Functions ... 10-1 General Information... 10-2 Backing Up All Data... 10-4 Restoring All Data ... 10-6 Saving Setup ... 10-8 Loading Setup ... 10-10 Creating a WDC Report... 10-12 Export Data Logs ... 10-14 Export/Import Archives ... 10-16 11. Data Logs... 11-1 General Information... 11-2 Patient Reports Log... 11-4 Patient Profile Log ... 11-8 Quality Control Log... 11-12 Calibration Log ... 11-18 Activity Log... 11-22 Archived Data Logs ... 11-26
3
Contents
ABL700 Series Operator’s Manual
12. Troubleshooting... 12-1 General Information... 12-2 Forced Hold Causes ... 12-5 Troubleshooting Messages... 12-7 Fluid Transport Troubleshooting Procedure ... 12-50 Inlet Probe Troubleshooting Procedure ... 12-52 Inlet Troubleshooting Procedure... 12-53 Leak Troubleshooting Procedure... 12-54 Electrode Troubleshooting Procedures ... 12-55 Pump Troubleshooting Procedure... 12-57 Fluid Transport System Description ... 12-58 13. Sampling Procedures... 13-1 Causes of errors in preanalytical phase... 13-2 Preparation prior to arterial/venous sampling ... 13-5 Preparation prior to capillary sampling... 13-7 Sampling devices ... 13-8 Storage and preparation prior to analysis... 13-9 Sampling procedures... 13-12 References... 13-14 14. Specifications and Accessories ... 14-1 Specifications... 14-2 Accessories and Ordering Information ... 14-13 Symbols Overview... 14-19 15. Appendix ... 15-1 Cleaning the Analyzer... 15-2 Checklist ... 15-4 Radiometer Default Settings ... 15-5 Contents of Setup Settings ... 15-16 Calibration Verification ... 15-19 Index T
Date of Issue T
4
1. 1. Introduction Introduction
This chapter gives you an introduction to your ABL700 Series analyzer. The chapter briefly describes the intended use of the analyzer, lists all measured parameters and the substances known to interfere with the measurements, and summarizes all the warning/caution notices that appear throughout the manual.
Contents
This chapter contains the following topics. 1-2
Names and Intended Use...
X
Limitations of Use...
X
1-6 X
Known Interfering Substances ...
X
Warning/Cautions and Notes ...
1-7 X
X
1-9 X
X
1. Introduction
ABL700 Series Operator's Manual
Names and Intended Use Proprietary Name
ABL700 Series Blood Gas, Oximetry, Electrolyte and Metabolite Systems.
Requirement to the Operator
The analyzer should be used by personnel who have received special education and training with regard to procedures utilizing in vitro diagnostic medical devices.
Measuring Capabilities
The ABL700 Series analyzers are designed for use on undiluted whole human blood and expired air. The following parameters can be measured on blood: Parameter Group
Parameters
pH/blood gas: pH (acidity) pCO2 (carbon dioxide tension) B
B
pO2 (oxygen tension) B
Oximetry:
B
ctHb (total hemoglobin concentration) sO2 (oxygen saturation) B
B
FO2Hb (fraction of oxyhemoglobin in total hemoglobin) B
B
FCOHb (fraction of carboxyhemoglobin in total hemoglobin) FHHb (fraction of deoxyhemoglobin in total hemoglobin) FMetHb (fraction of methemoglobin in total hemoglobin) FHbF (fraction of fetal hemoglobin) cK+ (potassium ion concentration)
Electrolytes:
P
P
cNa+ (sodium ion concentration) P
P
cCa2+ (calcium ion concentration) P
P
cCl– (chloride ion concentration) P
Metabolites:
P
cGlu (D-glucose concentration) cLac (L(+)-lactate concentration) ctBil (concentration of total bilirubin in plasma)
The following parameters can be measured on expired air samples: pCO2 Carbon dioxide tension B
pO2 B
B
B
Oxygen tension Continued on next page
1-2
ABL700 Series Operator's Manual
1. Introduction
Names and Intended Use, Continued T
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A list of all derived parameters calculated or estimated from the measured parameters is given in Chapter 14, Specifications and Accessories.
Derived Parameters
T
Chapter 6 in the Reference Manual gives a full description of all measured, derived, and input parameters available on the ABL700 Series analyzers. T
Versions of the ABL700 Series Analyzers
T
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The measuring capabilities of the ABL700 Series analyzers and the analyzer versions are listed below. NOTE: The following abbreviations for parameter groups were used: BG = pH/blood gases; MET = metabolites; OXI = oximetry. T
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Analyzer ABL700
Expired
ABL705
Expired
ABL710 ABL720
Expired
Measuring Modes, μL
Measured Parameters
Syringe - S85 μL and Capillary - C55 μL
All available
Capillary – pH only
pH
air
pCO2, pO2 B
B
B
B
Ampoule QC
All available
Other fluids (S85 and C55)
All available
Syringe - S165/95 μL and Capillary - C165/95
All available
Syringe - S85 μL BG and Capillary - C55 μL pH+BG
pH, pCO2, pO2
Capillary – pH only
pH
air
B
B
B
pCO2, pO2 B
B
B
B
B
Capillary - C35 μL MET
cGlu, cLac
Ampoule QC
All available
Other fluids (S85 and C55)
All available
Syringe - S85 μL and Capillary - C85 μL
All available
Capillary - C55 μL pH+BG
pH, pCO2, pO2
Capillary - C35 μL OXI
Available oximetry
Capillary – pH only
pH
air
T
T
B
B
B
pCO2, pO2 B
B
B
B
B
Ampoule QC
All available
Other fluids (S85 and C85)
All available Continued on next page
1-3
1. Introduction
ABL700 Series Operator's Manual
Names and Intended Use, Continued T
Versions of the ABL700 Series Analyzers (continued) T
Analyzer ABL725 ABL715
T
Measuring Modes (μL) Syringe - S195/95 μL and Capillary - C195/95 μL
Measured Parameters All available
Syringe - S85 μL pH+BG+OXI pH/blood gases and available oximetry Capillary - C55 μL pH+BG+OXI
Expired
ABL730
Expired
ABL735
Expired
Capillary - C35 μL MET
cGlu, cLac
Capillary - C35 μL OXI
Available oximetry
Capillary – pH only
pH
air
T
T
pCO2, pO2 B
B
B
B
Ampoule QC
All available
Other fluids (S195, C195)
All available
Syringe - S85 μL and Capillary - C85 μL
All available
Capillary - C55 μL pH+BG+OXI
pH/blood gases, oximetry +FHbF +ctBil
Capillary - C35 μL OXI
Oximetry + FHbF + ctBil
Capillary – pH only
pH
air
T
T
T
pCO2, pO2 B
B
B
T
B
Ampoule QC
All available
Other fluids (S85, C85)
All available
Syringe - S195/95 μL and Capillary - C195/95 μL
All available
Syringe – S85 μL pH+BG+OXI
pH/blood gases, oximetry +FHbF +ctBil
Capillary - C55 μL pH+BG+OXI
pH/blood gases, oximetry +FHbF +ctBil
Capillary - C35 μL MET
cGlu, cLac
Capillary - C35 μL OXI
Oximetry + FHbF + ctBil
Capillary – pH only
pH
air
T
T
T
T
T
T
T
pCO2, pO2 B
B
B
T
B
Ampoule QC
All available
Other fluids (S195, C195)
All available Continued on next page
1-4
ABL700 Series Operator's Manual
1. Introduction
Names and Intended Use, Continued T
T
Animal Blood
Animal blood has not been tested on the ABL700 Series analyzers. Some components in animal blood differ from those in human blood, and variations in the composition of blood from different animal species may also exist.
Other Fluids Mode
All parameters available on your ABL700 Series analyzer can be measured on fluids other than heparinized human whole blood. NOTE: Before using this mode you must establish "user-defined corrections" specified for the fluid in question. The corrections assume a linear correlation between the measured value and the reference instrument. The data used for establishing "user-defined corrections" have to cover the desired measuring range; an evaluation of the linearity within the range is necessary as well. If no user-defined corrections are entered, you will measure in this mode as if on heparinized whole human blood. T
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1-5
1. Introduction
ABL700 Series Operator's Manual
Limitations of Use WARNING/ CAUTION:
• The user should review the analyzer performance data to assure that the performance fulfills the user specific analytical needs. • The validity of the test results from this instrument must be carefully examined by a clinician and related to the patient’s clinical condition, before any clinical decisions are taken on the basis of the test results. T
• Bilirubin measurement in plasma requires a special capillary mode where all other parameters are deselected (see Analysis Setup in chapter 5) as only bilirubin has specifications for measurement on plasma. T
• WARNING - Risk of erroneous results. Always meticulously follow the sampling procedures described in Chapter 13: Sampling Procedures. Failure to follow these procedures may introduce clots or air bubbles in the sample and yield erroneous results. T
T
T
FHbF Measurement
The uncertainty in FHbF measurements exceeds the level required to measure normal HbF levels in the adult range (FHbF reference range is 0 - 1 %). The ABL700 Series analyzers are designed to measure HbA and HbF hemoglobins, not any other hemoglobin types.
1-6
ABL700 Series Operator's Manual
1. Introduction
Known Interfering Substances List of Interfering Substances
The following substances are known to affect or interfere with measurements on the ABL700 Series analyzers. For quantitative information on some interfering substances see Interference Tests in chapter 5 of the ABL700 Series Reference Manual. Substance
Interference
Halothane (anesthetic)
May give unreliable pO2 results.
Lipid therapy, protamine sulphate (treatment)
In OXI measurements.
Methylene Blue, HiCN (medication)
In OXI measurements.
Anions: Br − , I − , S 2− and ClO 4− (drugs)
Erroneously high cCl- results.
Anticoagulants (sampling)
Anticoagulants which contain sodium salts will give erroneously high cNa+ results. Sodium fluoride with or without EDTA and oxalate (di Na) influence cGlu results. Sodium fluoride gives erroneously high cNa+ and low cCa2+, cGlucose, and cLactate results. Tri sodium citrate influences cK+ and cGlu results. Thus RADIOMETER recommends the exclusive use of heparin as anticoagulant. Solutions containing organic preservatives may damage the ion-selective membranes of the K and glucose electrodes when introduced into the ABL700.
B
B
After measurement on blood from a patient who has received lipid therapy or protamine sulphate it may be necessary to clean the analyzer using the Cleaning program described in chapter 4: Analyzer Operation.
T
T
P
P
T
T
T
P
P
T
T
T
T
P
P
T
T
T
T
T
T
P
P
T
T
P
P
T
Erroneously high cGlu and cLac Thiocyanic Acid (degradation product from treatment with measurements. Nitroprussid. Also produced in thiosulphate treatment of cyanide poisoning) T
Glycolic Acid (ethyleneglycol degradation product)
T
T
T
Erroneously high cLac measurements. T
T
Continued on next page
1-7
1. Introduction
ABL700 Series Operator's Manual
Known Interfering Substances, Continued T
List of Interfering Substances (continued) T
T
Substance
Interference
Insufficiently stabilized blood;
Other fluids mode allows you to measure on fluids other than heparinized human blood.
caustic fluids (e.g. strong acids or bases, detergents, etc.); fluids that precipitate; fluids that affect the sensor enzymes; fluids that form complexes with the analyzer solutions (calcium);
WARNING/CAUTION: Be aware that some substances, such as listed in the left column, measured in the Other fluids mode may damage the instrument or the electrodes. This can affect the subsequent measurement on human blood or quality control solutions. T
T
T
high viscosity fluids; hydrophobic fluids; reactive fluids Carboxymethyl cellulose (CMC) Some auto-venting arterial blood samplers contain carboxymethyl cellulose (CMC) in the porous vent. CMC can dissolve into the sample and give erroneously low cCa results. Therefore we recommend to use Radiometer accessories together with our analyzers, e.g., PICO 70 arterial blood sampler which is specifically designed to minimize sample contamination with CMC. T
Galactose, glucosamine, mannose, xylose
1-8
T
Erroneously high cGlu measurements. T
T