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Provisional guidelines (1980) for listing specifications of clinical chemical analysers
Clin. Biochem. 13 (6) 244-248 (1980)
SPECIAL REPORT By the
International Federation of Clinical Chemistry Scientific Committee Expert Panel on Instrumentation [FCC Document 1980 Stage 2, Draft 1 1980-10-02 with a view to an IFCC Recommendation
PROVISIONAL G U I D E L I N E S (1980) FOR LISTING SPECIFICATIONS* OF CLINICAL CHEMICAL ANALYSERS Prepared by : K. O k u d a
Comments on these proposals should be sent before: 1981-09-30 to: Dr. F.L. Mitchell Division of Clinical Chemistry Clinical Research Centre Watford Road Harrow, Middlesex HA1 3UJ U.K. Comments from the viewpoint of languages other than English are encouraged. EP Members: F.L. Mitchell (London, U.K., Chairman) - K. Okuda (Osaka, Japan), T.D. Geary (Adelaide, Australia), Ch. Collombel (Lyon, France), R. Haeckel (Hanover, G.F.R.), R.G. Nadeau (New Jersey, U.S.A.). These Guidelines have been prepared for the Expert Panel by K. 0kuda with the collaboration of many colleagues both in Japan and other countries. After extensive review by the Panel early drafts were circulated widely to scientists in clinical laboratories as well as in industry. Many helpful comments were taken into account in the preparation of further drafts. The proposals have been discussed by the Area Committee on Instrumentation of the American National Committee for Clinical Laboratory Standards and again helpful comment has been taken into account. CONTENTS 1. Introduction .........................................
2. General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Chemical processor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5. Signal measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6. Signal handling .......................................
(1.) Introduction 1-i Many chemical analysers are now available for use in the field of clinical chemistry but as their specifications are not listed in a uniform format, it is difficult from the study of manufacturers' literature to select the i n s t r u m e n t most appropriate for a particular use. The Expert Panel considered that a standard format should be prepared to facilitate u n d e r s t a n d i n g of their relative merits. 1-2 It is suggested that manufacturers should use the following guidelines in the description of instruments. They should then state that they have done so, but if such a s t a t e m e n t is made, no information mentioned in the guidelines must be excluded unless it obviously does not apply to the instrum e n t in question. 1-3 Many of the items listed are not directly applicable to all i n s t r u m e n t s and appropriate modification is then suggested. It is hoped that in the i n t e r e s t of uniformity, manufacturers, in addition to providing the information requested, will also adhere to the same presentation format. For brevity, in this document, items are given only in the form of headings. 1-4 Similar guidelines have been produced for spectrometers in clinical chemistry (1) and are in preparation for flame emission and atomic absorption spectrometers and nephelometers.
(2.) General information 2-1 Model name and number. 2-2 Name and address of manufacturer 2-3 Date of completion of this listing of specifications by the m a n u f a c t u r e r 2-4 Brief history of the need for and development of the analyser 2-5 Function and any special feature of i n s t r u m e n t or system (maximum 100 words) 2-6 S u m m a r y of general specifications for i n s t r u m e n t or system 2-6-1 Mode of sampling 2-6-2 T r a n s p o r t 2-6-3 Chemical analytical processing 2-6-4 T e m p e r a t u r e control 2-6-5 Measuring 2-6-6 Signal handling 2-6-7 Type and format of data output
7. Data handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8. Additional technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (3.) Sampling 9. Information which should be available separately and locally ................................. 10. Photograph .......................................... ii. References ...........................................
* The publication of this document in Clinical Biochemistry is not intended to be an endorsement of the proposals it contains. It has been printed essentially without further editing, as a service to the profession of Clinical Chemistry - Editor-in-chief.
3-1 N a t u r e of specimen Urine Plasma Other 3-2 S p e c i m e n pretreatment required or available in in-
strument Column Dialysis Other
245
SPECIAL R E P O R T
3-3 Specimen container 3-3-1 Type {shape and material) 3-3-2 Total volume 3-3-3 Nonusable volume ("dead volume") 3-4 Operation of the system 3-5 Specimen protection from deterioration (prior to, or after presentation to instrument) Changes in temperature (not temperature control) Evaporation Light Gas diffusion Other 3-6 Specimen identification system (available or not) If available, give the method{s) 3-7 Maximum number of specimens per batch without re feeding 3-8 Interrupt capability to insert "stat" or emergency specimens. If availabale give degree of interference with normal running 3-9 Specimen and test throughput 3-9-1 Fixed or programmable Is automatic stop mechanism fitted? 3-9-2 Time required for each assay and rate of throughput of specimens 3-9-2-1 Maximum and minimum times and throughput rates 3-9-2-2 Tabulate for all chemical methods the time needed for one, five and one hundred specimens 3-10 Mechanism of specimen transport Turntable Endless chain drive Conveyor belt Other 3-11 Sampling mechanism 3-11-1Type Piston Rotating valve Proportioning pump Other 3-11-2Brief description of principle Drive mechanism of sampler 3-12 Sample aspiration and dispensing 3-12-1 Sample aspiration/dispensing, automatic/manual 3-12-2Volume of sample to be picked up/delivered 3-12-3If ajustable 3-12-3-1 Mechanism 3-12-3-2 Adjustment range 3-12-3-3 Adjustment increments 3-13 Carryover 3-13-1Carryover of analyte and reagent + 3-13-2Means for reduction (washing sampling tip, coating, etc.) 3-14 Inaccuracy + Sample/reagent ratio should be stated if relevant 3-15 Imprecision + Sample/reagent ratio should be stated if relevant
(4.) Chemical processor 4-1 General approach 4-1-1 Continuous flow 4-1-2 Discrete 4-1-3 Centrifugal 4-1-4 Combined and other 4-2 Mode of analytical system 4-2-1 Reagent 4-2-1-1 Prepacked reagents Available/mandatory from instrument supplier; from other suppliers Free choice of reagents including home made 4-2-1-2 Form of reagents Powder Tablet Liquid Other 4-2-2 Measurement approach 4-2-2-1 Single point/specify, as in Pardue (2) 4-2-2-2 Kinetic assay, variability of technique/ specify, as in Pardue (2) 4-2-2-3 Combination 4-2-3 Programmes* 4-2-3-1 Fixed programme* 4-2-3-1-1 Modifiable If yes, give the method(s) e.g. punched or magnetic card by user or manufacturer 4-2-3-2 Freely programmable* If yes, give the method(s) e.g. punched or magnetic card by user or manufacturer; key board 4-2-3-3 Special programmes* available
4-2-4 Blank correction (yes/no} e.g. reagent blank kinetic blank If yes, give the method(s) 4-2-5 Profile {multiple assay) {yes/no) If yes, give the method(s) 4-2-5-1 Selectable or fixed 4-2-5-2 Sequential {serial} or simultaneous (parallel} 4-2-6 Standards {calibrators) 4-2-6-1 Number of standards (calibrators) 4-2-6-2 Type of standard used e.q. aqueous or protein containing 4-2-6-3 Automatic computation of concentration relative to standards (calibrators} (yes/no} 4-2-7 Limitations of the system 4-3 Repertoire of analyte assays N u m b e r of different types of assay that may be performed at the same time on the same instrument
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4-3-1 Single/multi test -- sequential parallel 4-3-2 Minimum number of sequential or parallel tests at initial installation 4-3-3 Increment number of sequential or parallel tests which may be added 4-3-4 Maximum number of sequential or parallel tests 4-3-5 If multitest, can operation continue if one or more test units become inoperative? 4-3-6 Is repertoire fixed by manufacturer or chosen by user? 4-3-7 If repertoire can be changed, what is changeover time for each method? 4-3-8 Itemize methods available. Against each method give within-batch and between-batch imprecision ÷ 4-3-9 If fixed chemical methods can be modified or different techniques applied freely by user, how is programme* changed: i.e. keyboard, magnetic or punched cards, tapes, knobs, plug-board, etc.? 4-4
Reagent dispensing 4-4-1 Mechanism Piston Valve Proportioning pump Other 4-4-2 Number of dispensing stations per instrument/test 4-4-3 Volumes 4-4-3-1 Fixed 4-4-3-2 Adjustable c.f. 3-12-3 4-4-4 Inaccuracy ÷ See 3-14 Imprecision ÷ 4-4-5 See 3-15
4-5 Reagent addition and mixing 4-5-1 Precautions, corrosive reagents etc. 4-5-2 Reagent volume required for priming and/or dispensing. Reagent consumption per test. 4-5-3 Mixing mechanism Mechanical stirring Gas: jet/bubbling Rotation Centrifugal action Mixing coil Other 4-5-4 Ability to programme* 4-5-5 Separation or isolation If yes, give the method(s)
÷ Method of determination should be immediately evident; full details of technique should be available on request. "Where 'programming' of any type is mentioned, details should be given of the type of hardware and/or software used, together with the method of user modification, if this is possible.
4-6 Reaction vessel Test tube (plastic or glass) Tubing U-tube Plastic bag Centrifugal rotor Other 4-7 Means of transport and transfer of reaction mixture 4-7-1 Type Turntable Endless chain drive Conveyor belt Tubing with induced flow Centrifugal Other 4-7-2 Manual/automatic 4-7-3 Disposable/re-usable reaction vessel If re-usable, washing mechanism and fractional carryover ÷ Washing/drying of vessel Suction Decantation Jet washing (tap/distilled water) Other 4-8 Time control of reaction period 4-8-1 Minimal lag time in seconds between start of reaction and first possible reading 4-8-2 Range of controllable reaction interval (incubation time) 4-8-3 Range of total reaction time during which measurement can be made 4-8-4 Inaccuracy + and imprecision + of time control 4-9 Temperature control and monitoring system 4-9-1 Heating Bath-type Electro thermostatic block Other 4-9-2 Cooling 4-9-3 Range of temperature setting --Fixed - - Multipoint -Continuously variable 4-9-4 Temperature control - L o c a t i o n (reaction vessel, reagent etc) -- Method 4-9-5 Monitoring - Location -Method 4-9-6 Ambient temperature tolerance Miminum --Maximum 4-9-7 Time required to reach selected temperature for systems specified in 4-10-4 4-9-8 Humidity control; if required (inside instrument) 4-9-9 Eval~oration loss/if any 4-10 Calibration and/or procedure for maintaining precision and accuracy of results 4-10-1Amount of time required 4-10-2Frequency
SPECIAL R E P O R T
(5.) Signal measuring Follow the related guidelines e.g. absorption photometer (1) Note -- It may not be necessary to provide here, as much detail as is requested in the other guidelines. However, it is intended that the general format should be followed and the main points included.
(6.) Signal handling Follow the related guidelines e.g. absorption photometer (1) See note under * (7.) Data handling 7-1 I/O Port specification of output format with an example of data BCD Serial A S C I I RS 232 Other 7-2 Microprocessor (type, size and function} Output available? If so, describe 7-3 Output - F o r m a t , fixed or variable -- Method, printout or display 7-3-1 Contents 7-3-1-1 Test data e.g. concentration or other 7-3-1-2 Specimen identification 7-3-1-3 Additional information - r e f e r e n c e values -- other 7-3-1-4 Units 7-4 Automatic warning Number and type of errors which are indicated automatically e.g. outside limits, non-linear, abnormal, invalid, other 7-5 Data storage If yes, give type and quantity of information stored
(8.) Additional technical data 8-1 Requirements 8-1-1 Line voltage, amperage and frequency requirement including tolerated intervals, starting currents, load and continuous load, grounding (3) 8-1-1-1 Power surge protection Safety shut-off switch 8-1-2 Water supply 8-1-2-1 Tap water, distilled 8-1-2-2 Volume rate 8-1-2-3 Pressure 8-1-3 Air pressure and/or vacuum 8-1-4 Gas 8-1-4-1 Type and purity 8-1-4-2 Volume rate 8-1-4-3 Pressure
247
8-1-5 Any other supply required 8-1-6 Laboratory environment 8-1-6-1 Humidity 8-1-6-2 Other than temperature 8-1-7 Dimensions (height, length, width) Mass (weight) 8-2 Miscellaneous 8-2-1 Reagent supply for analyser If special reagents are required give details of availability in relevant countries 8-2-2 Alarm (yes/no) Give details of function of monitoring system 8-2-3 Starting period, up to time when first specimen may be inserted 8-2-3-1 From off 8-2-3-2 From stand-by mode 8-2-4 Environmental impact and safety Corrosive reagents Toxic waste Noise Precautions for operator e.g. dangerous radiation (laser, xenon, y-ray, vibration, fumes, biological hazards) Other 8-2-5 Maintenance -- routine and preventive: time and frequency c.f. ASI-1 document of NCCLS (4) 8-2-6 Waste handling e.g. drainage required: any special requirements for waste disposal 8-2-7 Optional accessories, e.g. recorder 8-2-8 Operator training requirement c.f. TSI-6 document of NCCLS (5)
(9.) Information which should be available separately and locally 9-1 Cost 9-1-1 9-1-2 9-1-3 9-1-4 9-1-5
Instrument Parts Options Training Single use items: Cups Cuvettes Reagents 9-1-6 Estimated cost per test 9-2 Service and maintenance; degree of maintenance possible with normal laboratory staff Availability of service, e.g. 24h/day and from what location 9-3 Other special information (10.) A photograph of an outside view of the instrument should be provided together with a block diagram illustrating the method of operation of the main system. If similar diagrams of subsystems would aid clarity, these should be provided also.
(11.) References.
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248
mittee for Clinical Laboratory Standards, 771 East Lancaster Avenue, Villanova PA 19088, U.S.A. ASI-1 Preparation of manuals for installation, operation and repair of laboratory instruments, 771 East Lancaster Avenue, Vfllanova, PA 19088, U.S.A.
REFERENCES 1.
2. 3.
Haeckel, R., Collombel, Ch., Geary, T.D., Mitchell, F.L., Nadeau, R.G., and Okuda, K. Provisional Guidelines (1979)for Listing Specifications of Spectrometers in Clinical Chemistry. Clin. Chim. Acta 103, 249F-258F {1980). Pardue, H. Cli~ Chem. 23, 2189-2201 (1977). TSi-5, Power requirements for clinical laboratory instruments and for laboratory power lines. National Corn-
5.
JF
TSI-6, Guidelines for service of clinical laboratory instruments, National Committee for Clinical Laboratory Standards, 771 East Lancaster Avenue, Villanova, PA 19088, U.S.A.
SPECIAL REPORT By the
International Federation of Clinical Chemistry Scientific Committee Expert Panel on Instrumentation [FCC Document 1980 Stage 2, Draft 1 1980-10-02 with a view to an IFCC Recommendation
PROVISIONAL G U I D E L I N E S (1980) FOR LISTING SPECIFICATIONS* OF CLINICAL CHEMICAL ANALYSERS Prepared by : K. O k u d a
Comments on these proposals should be sent before: 1981-09-30 to: Dr. F.L. Mitchell Division of Clinical Chemistry Clinical Research Centre Watford Road Harrow, Middlesex HA1 3UJ U.K. Comments from the viewpoint of languages other than English are encouraged. EP Members: F.L. Mitchell (London, U.K., Chairman) - K. Okuda (Osaka, Japan), T.D. Geary (Adelaide, Australia), Ch. Collombel (Lyon, France), R. Haeckel (Hanover, G.F.R.), R.G. Nadeau (New Jersey, U.S.A.). These Guidelines have been prepared for the Expert Panel by K. 0kuda with the collaboration of many colleagues both in Japan and other countries. After extensive review by the Panel early drafts were circulated widely to scientists in clinical laboratories as well as in industry. Many helpful comments were taken into account in the preparation of further drafts. The proposals have been discussed by the Area Committee on Instrumentation of the American National Committee for Clinical Laboratory Standards and again helpful comment has been taken into account. CONTENTS 1. Introduction .........................................
2. General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Chemical processor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5. Signal measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6. Signal handling .......................................
(1.) Introduction 1-i Many chemical analysers are now available for use in the field of clinical chemistry but as their specifications are not listed in a uniform format, it is difficult from the study of manufacturers' literature to select the i n s t r u m e n t most appropriate for a particular use. The Expert Panel considered that a standard format should be prepared to facilitate u n d e r s t a n d i n g of their relative merits. 1-2 It is suggested that manufacturers should use the following guidelines in the description of instruments. They should then state that they have done so, but if such a s t a t e m e n t is made, no information mentioned in the guidelines must be excluded unless it obviously does not apply to the instrum e n t in question. 1-3 Many of the items listed are not directly applicable to all i n s t r u m e n t s and appropriate modification is then suggested. It is hoped that in the i n t e r e s t of uniformity, manufacturers, in addition to providing the information requested, will also adhere to the same presentation format. For brevity, in this document, items are given only in the form of headings. 1-4 Similar guidelines have been produced for spectrometers in clinical chemistry (1) and are in preparation for flame emission and atomic absorption spectrometers and nephelometers.
(2.) General information 2-1 Model name and number. 2-2 Name and address of manufacturer 2-3 Date of completion of this listing of specifications by the m a n u f a c t u r e r 2-4 Brief history of the need for and development of the analyser 2-5 Function and any special feature of i n s t r u m e n t or system (maximum 100 words) 2-6 S u m m a r y of general specifications for i n s t r u m e n t or system 2-6-1 Mode of sampling 2-6-2 T r a n s p o r t 2-6-3 Chemical analytical processing 2-6-4 T e m p e r a t u r e control 2-6-5 Measuring 2-6-6 Signal handling 2-6-7 Type and format of data output
7. Data handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8. Additional technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (3.) Sampling 9. Information which should be available separately and locally ................................. 10. Photograph .......................................... ii. References ...........................................
* The publication of this document in Clinical Biochemistry is not intended to be an endorsement of the proposals it contains. It has been printed essentially without further editing, as a service to the profession of Clinical Chemistry - Editor-in-chief.
3-1 N a t u r e of specimen Urine Plasma Other 3-2 S p e c i m e n pretreatment required or available in in-
strument Column Dialysis Other
245
SPECIAL R E P O R T
3-3 Specimen container 3-3-1 Type {shape and material) 3-3-2 Total volume 3-3-3 Nonusable volume ("dead volume") 3-4 Operation of the system 3-5 Specimen protection from deterioration (prior to, or after presentation to instrument) Changes in temperature (not temperature control) Evaporation Light Gas diffusion Other 3-6 Specimen identification system (available or not) If available, give the method{s) 3-7 Maximum number of specimens per batch without re feeding 3-8 Interrupt capability to insert "stat" or emergency specimens. If availabale give degree of interference with normal running 3-9 Specimen and test throughput 3-9-1 Fixed or programmable Is automatic stop mechanism fitted? 3-9-2 Time required for each assay and rate of throughput of specimens 3-9-2-1 Maximum and minimum times and throughput rates 3-9-2-2 Tabulate for all chemical methods the time needed for one, five and one hundred specimens 3-10 Mechanism of specimen transport Turntable Endless chain drive Conveyor belt Other 3-11 Sampling mechanism 3-11-1Type Piston Rotating valve Proportioning pump Other 3-11-2Brief description of principle Drive mechanism of sampler 3-12 Sample aspiration and dispensing 3-12-1 Sample aspiration/dispensing, automatic/manual 3-12-2Volume of sample to be picked up/delivered 3-12-3If ajustable 3-12-3-1 Mechanism 3-12-3-2 Adjustment range 3-12-3-3 Adjustment increments 3-13 Carryover 3-13-1Carryover of analyte and reagent + 3-13-2Means for reduction (washing sampling tip, coating, etc.) 3-14 Inaccuracy + Sample/reagent ratio should be stated if relevant 3-15 Imprecision + Sample/reagent ratio should be stated if relevant
(4.) Chemical processor 4-1 General approach 4-1-1 Continuous flow 4-1-2 Discrete 4-1-3 Centrifugal 4-1-4 Combined and other 4-2 Mode of analytical system 4-2-1 Reagent 4-2-1-1 Prepacked reagents Available/mandatory from instrument supplier; from other suppliers Free choice of reagents including home made 4-2-1-2 Form of reagents Powder Tablet Liquid Other 4-2-2 Measurement approach 4-2-2-1 Single point/specify, as in Pardue (2) 4-2-2-2 Kinetic assay, variability of technique/ specify, as in Pardue (2) 4-2-2-3 Combination 4-2-3 Programmes* 4-2-3-1 Fixed programme* 4-2-3-1-1 Modifiable If yes, give the method(s) e.g. punched or magnetic card by user or manufacturer 4-2-3-2 Freely programmable* If yes, give the method(s) e.g. punched or magnetic card by user or manufacturer; key board 4-2-3-3 Special programmes* available
4-2-4 Blank correction (yes/no} e.g. reagent blank kinetic blank If yes, give the method(s) 4-2-5 Profile {multiple assay) {yes/no) If yes, give the method(s) 4-2-5-1 Selectable or fixed 4-2-5-2 Sequential {serial} or simultaneous (parallel} 4-2-6 Standards {calibrators) 4-2-6-1 Number of standards (calibrators) 4-2-6-2 Type of standard used e.q. aqueous or protein containing 4-2-6-3 Automatic computation of concentration relative to standards (calibrators} (yes/no} 4-2-7 Limitations of the system 4-3 Repertoire of analyte assays N u m b e r of different types of assay that may be performed at the same time on the same instrument
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4-3-1 Single/multi test -- sequential parallel 4-3-2 Minimum number of sequential or parallel tests at initial installation 4-3-3 Increment number of sequential or parallel tests which may be added 4-3-4 Maximum number of sequential or parallel tests 4-3-5 If multitest, can operation continue if one or more test units become inoperative? 4-3-6 Is repertoire fixed by manufacturer or chosen by user? 4-3-7 If repertoire can be changed, what is changeover time for each method? 4-3-8 Itemize methods available. Against each method give within-batch and between-batch imprecision ÷ 4-3-9 If fixed chemical methods can be modified or different techniques applied freely by user, how is programme* changed: i.e. keyboard, magnetic or punched cards, tapes, knobs, plug-board, etc.? 4-4
Reagent dispensing 4-4-1 Mechanism Piston Valve Proportioning pump Other 4-4-2 Number of dispensing stations per instrument/test 4-4-3 Volumes 4-4-3-1 Fixed 4-4-3-2 Adjustable c.f. 3-12-3 4-4-4 Inaccuracy ÷ See 3-14 Imprecision ÷ 4-4-5 See 3-15
4-5 Reagent addition and mixing 4-5-1 Precautions, corrosive reagents etc. 4-5-2 Reagent volume required for priming and/or dispensing. Reagent consumption per test. 4-5-3 Mixing mechanism Mechanical stirring Gas: jet/bubbling Rotation Centrifugal action Mixing coil Other 4-5-4 Ability to programme* 4-5-5 Separation or isolation If yes, give the method(s)
÷ Method of determination should be immediately evident; full details of technique should be available on request. "Where 'programming' of any type is mentioned, details should be given of the type of hardware and/or software used, together with the method of user modification, if this is possible.
4-6 Reaction vessel Test tube (plastic or glass) Tubing U-tube Plastic bag Centrifugal rotor Other 4-7 Means of transport and transfer of reaction mixture 4-7-1 Type Turntable Endless chain drive Conveyor belt Tubing with induced flow Centrifugal Other 4-7-2 Manual/automatic 4-7-3 Disposable/re-usable reaction vessel If re-usable, washing mechanism and fractional carryover ÷ Washing/drying of vessel Suction Decantation Jet washing (tap/distilled water) Other 4-8 Time control of reaction period 4-8-1 Minimal lag time in seconds between start of reaction and first possible reading 4-8-2 Range of controllable reaction interval (incubation time) 4-8-3 Range of total reaction time during which measurement can be made 4-8-4 Inaccuracy + and imprecision + of time control 4-9 Temperature control and monitoring system 4-9-1 Heating Bath-type Electro thermostatic block Other 4-9-2 Cooling 4-9-3 Range of temperature setting --Fixed - - Multipoint -Continuously variable 4-9-4 Temperature control - L o c a t i o n (reaction vessel, reagent etc) -- Method 4-9-5 Monitoring - Location -Method 4-9-6 Ambient temperature tolerance Miminum --Maximum 4-9-7 Time required to reach selected temperature for systems specified in 4-10-4 4-9-8 Humidity control; if required (inside instrument) 4-9-9 Eval~oration loss/if any 4-10 Calibration and/or procedure for maintaining precision and accuracy of results 4-10-1Amount of time required 4-10-2Frequency
SPECIAL R E P O R T
(5.) Signal measuring Follow the related guidelines e.g. absorption photometer (1) Note -- It may not be necessary to provide here, as much detail as is requested in the other guidelines. However, it is intended that the general format should be followed and the main points included.
(6.) Signal handling Follow the related guidelines e.g. absorption photometer (1) See note under * (7.) Data handling 7-1 I/O Port specification of output format with an example of data BCD Serial A S C I I RS 232 Other 7-2 Microprocessor (type, size and function} Output available? If so, describe 7-3 Output - F o r m a t , fixed or variable -- Method, printout or display 7-3-1 Contents 7-3-1-1 Test data e.g. concentration or other 7-3-1-2 Specimen identification 7-3-1-3 Additional information - r e f e r e n c e values -- other 7-3-1-4 Units 7-4 Automatic warning Number and type of errors which are indicated automatically e.g. outside limits, non-linear, abnormal, invalid, other 7-5 Data storage If yes, give type and quantity of information stored
(8.) Additional technical data 8-1 Requirements 8-1-1 Line voltage, amperage and frequency requirement including tolerated intervals, starting currents, load and continuous load, grounding (3) 8-1-1-1 Power surge protection Safety shut-off switch 8-1-2 Water supply 8-1-2-1 Tap water, distilled 8-1-2-2 Volume rate 8-1-2-3 Pressure 8-1-3 Air pressure and/or vacuum 8-1-4 Gas 8-1-4-1 Type and purity 8-1-4-2 Volume rate 8-1-4-3 Pressure
247
8-1-5 Any other supply required 8-1-6 Laboratory environment 8-1-6-1 Humidity 8-1-6-2 Other than temperature 8-1-7 Dimensions (height, length, width) Mass (weight) 8-2 Miscellaneous 8-2-1 Reagent supply for analyser If special reagents are required give details of availability in relevant countries 8-2-2 Alarm (yes/no) Give details of function of monitoring system 8-2-3 Starting period, up to time when first specimen may be inserted 8-2-3-1 From off 8-2-3-2 From stand-by mode 8-2-4 Environmental impact and safety Corrosive reagents Toxic waste Noise Precautions for operator e.g. dangerous radiation (laser, xenon, y-ray, vibration, fumes, biological hazards) Other 8-2-5 Maintenance -- routine and preventive: time and frequency c.f. ASI-1 document of NCCLS (4) 8-2-6 Waste handling e.g. drainage required: any special requirements for waste disposal 8-2-7 Optional accessories, e.g. recorder 8-2-8 Operator training requirement c.f. TSI-6 document of NCCLS (5)
(9.) Information which should be available separately and locally 9-1 Cost 9-1-1 9-1-2 9-1-3 9-1-4 9-1-5
Instrument Parts Options Training Single use items: Cups Cuvettes Reagents 9-1-6 Estimated cost per test 9-2 Service and maintenance; degree of maintenance possible with normal laboratory staff Availability of service, e.g. 24h/day and from what location 9-3 Other special information (10.) A photograph of an outside view of the instrument should be provided together with a block diagram illustrating the method of operation of the main system. If similar diagrams of subsystems would aid clarity, these should be provided also.
(11.) References.
OKUDA
248
mittee for Clinical Laboratory Standards, 771 East Lancaster Avenue, Villanova PA 19088, U.S.A. ASI-1 Preparation of manuals for installation, operation and repair of laboratory instruments, 771 East Lancaster Avenue, Vfllanova, PA 19088, U.S.A.
REFERENCES 1.
2. 3.
Haeckel, R., Collombel, Ch., Geary, T.D., Mitchell, F.L., Nadeau, R.G., and Okuda, K. Provisional Guidelines (1979)for Listing Specifications of Spectrometers in Clinical Chemistry. Clin. Chim. Acta 103, 249F-258F {1980). Pardue, H. Cli~ Chem. 23, 2189-2201 (1977). TSi-5, Power requirements for clinical laboratory instruments and for laboratory power lines. National Corn-
5.
JF
TSI-6, Guidelines for service of clinical laboratory instruments, National Committee for Clinical Laboratory Standards, 771 East Lancaster Avenue, Villanova, PA 19088, U.S.A.