HTI BioChem FC-360 User manual

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL
High Technology, Inc.
109 Production Road, Walpole MA 02081 USA
Automatic Chemistry Analyzer
HTI BioChem FC-360
Operator’s Manual
Document Number
:
OM-E-FC-360-30
Revision Level
:
Rev. 3
Effective Date
:
8/15/2016

High Technology, Inc.
109 Production Road,
Walpole MA 02081 USA
Document Number
OM-E-FC-360-30
Revision Level
Rev. 3
Prepared by
J.S. Bolio
Approved by
S. Titov
Effective Date
8/15/2016
Operator’s Manual: HTI BioChem FC-360
HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL I
Contents
INTENDED USE ........................................................................................................................................................1
1TRANSPORTATION, STORAGE AND UNPACKING......................................................................................4
TRANSPORTATION AND STORAGE.......................................................................................................4
UNPACKING INSTRUCTIONS..................................................................................................................5
2INSTALLATION.................................................................................................................................................7
ELECTRICAL REQUIREMENTS...............................................................................................................7
DIMENSIONS.............................................................................................................................................7
ENVIRONMENTAL REQUIREMENTS......................................................................................................8
MOVING THE INSTRUMENT....................................................................................................................8
PC MINIMUM REQUIREMENTS...............................................................................................................8
INSTRUMENT PLACEMENT AND PREPARATION.................................................................................8
WIRES AND TUBING CONNECTION.......................................................................................................9
Washing solution..............................................................................................................................11
2.7.1.1 Washing solution for probe and cuvettes .....................................................................................................................11
2.7.1.2 Washing solution for probe and cuvettes when running turbidimetric methods.........................................................12
INSTALLATION........................................................................................................................................12
PC configuration...............................................................................................................................12
2.8.1.1 Install analyzer software. .............................................................................................................................................. 12
Analyzer setup..................................................................................................................................13
3ANALYZER TECHNICAL SPECIFICATIONS ................................................................................................14
GENERAL SPECIFICATIONS.................................................................................................................15
SAMPLE/REAGENT TRAY......................................................................................................................15
CUVETTES/REACTION TRAY................................................................................................................15
DISPENSING ARM AND HYDRAULIC SYSTEM....................................................................................16
CUVETTE WASHER................................................................................................................................16
PHOTOMETER........................................................................................................................................16
ISE MODULE (OPTIONAL) .....................................................................................................................16
SOFTWARE.............................................................................................................................................17
POWER REQUIREMENT........................................................................................................................17
DESCRIPTION OF ELECTRONIC CIRCUITS........................................................................................17
TYPES OF SAMPLES .............................................................................................................................18
TYPES OF REACTIONS .........................................................................................................................18
TYPES OF METHODS ............................................................................................................................18
4GENERAL FUNCTIONS..................................................................................................................................18
MAIN PARTS OR MODULES..................................................................................................................18
Sample/Reagent Tray ......................................................................................................................19
Dispensing Arm and Probe ..............................................................................................................20
Cuvette/Reaction Tray .....................................................................................................................20
Cuvette Washer................................................................................................................................22
Hydraulic System .............................................................................................................................23
Optical System.................................................................................................................................24
ISE Module (Optional)......................................................................................................................25
DESCRIPTION OF THE OPERATING CYCLE.......................................................................................25
Reaction Preparation Cycle .............................................................................................................26
Incubation and Reading Cycle .........................................................................................................26
Cuvette Washing Cycle....................................................................................................................26
ISE processing cycle (Optional).......................................................................................................26

High Technology, Inc.
109 Production Road,
Walpole MA USA 02081
Document Number
OM-E-FC-360-30
Revision Level
Rev. 3
Prepared By
J.S. Bolio
Approved By
S. Titov
Effective date
8/15/2016
Operator’s Manual: HTI BioChem FC-360
II HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL
5BASIC OPERATIONS .....................................................................................................................................27
INITIAL CONFIGURATION OF THE PROGRAM....................................................................................27
DAILY OPERATION.................................................................................................................................27
PROGRAMMED MAINTENANCE ...........................................................................................................28
6SOFTWARE TABS..........................................................................................................................................29
MAIN WINDOW OF THE SOFTWARE....................................................................................................29
OPERATIONS TAB..................................................................................................................................30
REAGENTS TRAYS TAB ........................................................................................................................33
Reagent position ..............................................................................................................................33
PAT RESULTS TAB.................................................................................................................................35
Patient results search.......................................................................................................................37
Advanced search..............................................................................................................................40
CAL RESULTS TAB.................................................................................................................................44
CON RESULTS TAB................................................................................................................................45
SAMPLE POSITIONS TAB......................................................................................................................47
7OPERATIONS MENU......................................................................................................................................48
ADD SAMPLES AND METHODS............................................................................................................48
Add Sample......................................................................................................................................49
7.1.1.1 Add Patient...................................................................................................................................50
7.1.1.2 Add Calibrator ..............................................................................................................................52
7.1.1.3 Add Control ..................................................................................................................................52
Add Methods....................................................................................................................................53
MODIFY SAMPLE....................................................................................................................................54
DELETE SAMPLES AND METHODS......................................................................................................55
Delete Sample..................................................................................................................................56
Delete Selected Method...................................................................................................................57
PENDING: SAVE, LOAD AND IMPORT PENDING REQUESTS ...........................................................58
Save Pending...................................................................................................................................59
Load Pending...................................................................................................................................59
Import from CSV...............................................................................................................................60
SAMPLES TO TRAY................................................................................................................................60
SAMPLES TO TRAY (BARCODE) (OPTIONAL).....................................................................................63
WASH CUVETTES ..................................................................................................................................67
START......................................................................................................................................................68
STOP........................................................................................................................................................69
PAUSE .....................................................................................................................................................69
PRINT RESULTS.....................................................................................................................................71
REPEAT RESULTS .................................................................................................................................74
RELOAD SAMPLES ................................................................................................................................75
EXPORT RESULTS.................................................................................................................................75
8METHODS MENU............................................................................................................................................76
SETTINGS: METHODS CONFIGURATION............................................................................................76
General Tab .....................................................................................................................................77
Factor Tab........................................................................................................................................79
Reference Values Tab......................................................................................................................82
Specials Tab.....................................................................................................................................83
8.1.4.1 End Point Reagent Blank.............................................................................................................83
8.1.4.2 End Point Sample Blank ..............................................................................................................85
8.1.4.3 Kinetics.........................................................................................................................................87
8.1.4.4 Fixed Time Kinetics......................................................................................................................89
Advanced tab ...................................................................................................................................91
ISE METHODS SETTINGS (OPTIONAL)................................................................................................94

High Technology, Inc.
109 Production Road,
Walpole MA 02081 USA
Document Number
OM-E-FC-360-30
Revision Level
Rev. 3
Prepared by
J.S. Bolio
Approved by
S. Titov
Effective Date
8/15/2016
Operator’s Manual: HTI BioChem FC-360
HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL III
General Tab (ISE)............................................................................................................................94
Factor tab (ISE)................................................................................................................................96
Special Tab (ISE).............................................................................................................................97
Advanced tab (ISE)..........................................................................................................................98
REAGENTS IN USE AND PROFILES...................................................................................................100
SAVING METHODS...............................................................................................................................101
LOADING METHODS............................................................................................................................102
SAVING PROFILES...............................................................................................................................103
LOADING PROFILES ............................................................................................................................103
9CALIBRATORS MENU .................................................................................................................................104
SETTINGS .............................................................................................................................................104
SAVING CALIBRATORS FILES............................................................................................................106
LOADING CALIBRATORS FILES .........................................................................................................106
10 CONTROLS MENU ...................................................................................................................................106
SETTINGS .............................................................................................................................................107
SAVING CONTROLS FILES..................................................................................................................108
LOADING CONTROLS FILES...............................................................................................................108
11 STATISTICS MENU...................................................................................................................................108
LEVY-JENNINGS OF PATIENTS..........................................................................................................108
LEVY-JENNINGS OF CALIBRATORS..................................................................................................110
LEVY-JENNINGS OF CONTROLS........................................................................................................111
QUALITY CONTROL .............................................................................................................................112
12 MAINTENANCE MENU.............................................................................................................................115
SETTINGS .............................................................................................................................................116
Serial Port Tab ...............................................................................................................................116
Files Tab.........................................................................................................................................116
Database Tab.................................................................................................................................118
Ages Tab........................................................................................................................................120
Reports Tab....................................................................................................................................121
Memory Tab...................................................................................................................................123
Language/ Style Tab......................................................................................................................124
Access Control Tab........................................................................................................................125
CUVETTES STATUS.............................................................................................................................125
CONTAINERS STATUS ........................................................................................................................127
PROGRAMMED WASHING ..................................................................................................................127
TIP CLEANING ......................................................................................................................................128
COMMUNICATIONS..............................................................................................................................129
Commands Console.......................................................................................................................129
Serial Port Log................................................................................................................................130
VALIDATIONS........................................................................................................................................131
Stray Light......................................................................................................................................132
Photometer Precision.....................................................................................................................133
Photometric Accuracy ....................................................................................................................134
Photometric Linearity .....................................................................................................................135
6. Select Maintenance Validations Photometric Linearity Cuvette Number OK ..............135
Diluter Precision.............................................................................................................................137
Precision test P150 and P250........................................................................................................139
12.7.6.1 P150 Method..............................................................................................................................141
12.7.6.2 P250 Method..............................................................................................................................143
INSTRUMENT........................................................................................................................................145
Calibration......................................................................................................................................145

High Technology, Inc.
109 Production Road,
Walpole MA USA 02081
Document Number
OM-E-FC-360-30
Revision Level
Rev. 3
Prepared By
J.S. Bolio
Approved By
S. Titov
Effective date
8/15/2016
Operator’s Manual: HTI BioChem FC-360
IV HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL
12.8.1.1 Photometer calibration ...............................................................................................................145
12.8.1.2 Cuvettes calibration....................................................................................................................146
Diluter purge...................................................................................................................................146
Washer purge.................................................................................................................................147
Initialize ..........................................................................................................................................147
ISE (Optional).................................................................................................................................147
12.8.5.1 Start up.......................................................................................................................................148
12.8.5.2 Calibrant A purge .......................................................................................................................149
12.8.5.3 Calibrant B purge .......................................................................................................................149
12.8.5.4 Calibration ..................................................................................................................................149
12.8.5.5 Clean..........................................................................................................................................150
12.8.5.6 Pumps Calibration......................................................................................................................150
12.8.5.7 Bubble Sensor Calibration .........................................................................................................151
12.8.5.8 Electrode replacement ...............................................................................................................151
12.8.5.9 Reagent Kit Replacement ..........................................................................................................152
12.8.5.10 Reconnect ..............................................................................................................................153
13 ADVANCED OPERATIONS......................................................................................................................153
CONFIGURATION OF THE PRINTING FORMATS..............................................................................153
FILE EXCHANGE...................................................................................................................................156
IMPORTING SAMPLES FROM AN ADMINISTRATION PROGRAM ...................................................156
EXPORTING RESULTS TO THE ADMINISTRATION PROGRAM ......................................................157
DETERMINATION OF PRECISION OF AN ANALYTIC METHOD.......................................................161
DIRECT READING OF THE SOLUTION ABSORBANCE.....................................................................161
14 ISE MODULE: DESCRIPTION AND OPERATION (OPTIONAL) ............................................................163
ELECTRODES.......................................................................................................................................164
FLUID MANAGEMENT..........................................................................................................................165
SAMPLE TYPE ......................................................................................................................................165
Sample Handling and Collection....................................................................................................166
14.3.1.1 Serum.........................................................................................................................................166
14.3.1.2 Plasma .......................................................................................................................................166
14.3.1.3 Urine Samples............................................................................................................................166
14.3.1.4 Matrix Effects..............................................................................................................................166
Reagent Kit Electronic Key ............................................................................................................167
SAMPLE ASPIRATING AND DISPENSING..........................................................................................167
CALIBRATION CYCLE ..........................................................................................................................167
CLEAN CYCLE ......................................................................................................................................169
PURGE A CYCLE..................................................................................................................................169
PURGE B CYCLE..................................................................................................................................169
SIP CYCLE.............................................................................................................................................169
OFF CYCLE (UNDER ELECTRODE REPLACEMENT COMMAND) ...............................................169
PUMP CALIBRATION CYCLE...........................................................................................................170
BUBBLE CAL CYCLE........................................................................................................................170
MAINTENANCE.................................................................................................................................170
Before starting daily operation ...................................................................................................170
Daily Maintenance......................................................................................................................170
Shutdown Procedure..................................................................................................................171
ISE Module re-activation............................................................................................................171
ISE TROUBLESHOOTING ................................................................................................................171

High Technology, Inc.
109 Production Road,
Walpole MA 02081 USA
Document Number
OM-E-FC-360-30
Revision Level
Rev. 3
Prepared by
J.S. Bolio
Approved by
S. Titov
Effective Date
8/15/2016
Operator’s Manual: HTI BioChem FC-360
HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL V
15 MAINTENANCE PROGRAM.....................................................................................................................175
DAILY MAINTENANCE..........................................................................................................................175
Before starting daily operation .......................................................................................................175
Maintenance Instrument Diluter Purge .............................................................................................175
During the daily operation ..............................................................................................................176
Upon finishing with the daily operation...........................................................................................176
WEEKLY MAINTENANCE.....................................................................................................................176
MONTHLY MAINTENANCE ..................................................................................................................176
External washing of cuvettes .........................................................................................................176
General cleaning of the instrument................................................................................................177
Back-up of files in use....................................................................................................................177
ISE MODULE MAINTENANCE PROGRAM (OPTIONAL) ....................................................................178
Recommended Component Replacement Schedule (low volume user).......................................178
Recommended Replacement Schedule (high volume user) .........................................................178
MAINTENANCE ACCORDING TO PROGRAMMED ALARMS ............................................................179
Maintenance Levels according to cycles of use counters..............................................................179
Maintenance Level 1......................................................................................................................179
15.5.2.1 Disinfecting the reagent tray ......................................................................................................179
15.5.2.2 Disinfecting the tubing and cleaning of the containers...............................................................180
15.5.2.3 General cleaning of the instrument............................................................................................180
15.5.2.4 Axes lubrication..........................................................................................................................180
15.5.2.5 Cleaning of the washer circuit filter ............................................................................................181
15.5.2.6 Replacement of the Teflon seals in the piston pump.................................................................181
15.5.2.7 Flushing Pump Membrane replacement....................................................................................181
15.5.2.8 Diluter Liquid Diaphragm Pump Membrane replacement..........................................................181
Maintenance Level 2......................................................................................................................181
15.5.3.1 Disinfecting the reagent tray ......................................................................................................181
15.5.3.2 Disinfecting the tubing and cleaning of the containers...............................................................181
15.5.3.3 General cleaning of the instrument............................................................................................181
15.5.3.4 Axes lubrication..........................................................................................................................181
15.5.3.5 Cleaning of the washer circuit filter ............................................................................................181
15.5.3.6 Replacement of the Teflon seals in the piston pump.................................................................181
15.5.3.7 Flushing Pump Membrane Replacement...................................................................................181
15.5.3.8 Diluter Liquid Diaphragm Pump Membrane Replacement ........................................................182
15.5.3.9 Cuvettes replacement ................................................................................................................182
AS NEEDED MAINTENANCE...............................................................................................................182
Database Initialization (every 10.000 tests)...................................................................................182
Lamp replacement..........................................................................................................................183
Cuvettes Replacement (see item 15.5.3.8)....................................................................................185
15.6.3.1 Interferential filters replacement.................................................................................................185
Sample / Reagent probe replacement ...........................................................................................185
Replacing the fuses........................................................................................................................189
Special Wash .................................................................................................................................189
Replacing O-rings of piston pump..................................................................................................189
Replacing filters of washing system...............................................................................................189
Electrode replacement (For analyzers with ISE Module installed) ................................................190
15.6.9.1 Replacing ISE peristaltic pumps tubing (For analyzers with ISE Module installed)...................191

High Technology, Inc.
109 Production Road,
Walpole MA USA 02081
Document Number
OM-E-FC-360-30
Revision Level
Rev. 3
Prepared By
J.S. Bolio
Approved By
S. Titov
Effective date
8/15/2016
Operator’s Manual: HTI BioChem FC-360
VI HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL
16 PREPARING SOLUTIONS........................................................................................................................191
WASH SOLUTION.................................................................................................................................191
Washing solution for probe and cuvettes.......................................................................................191
Washing solution for probe and cuvettes when running turbidimetric methods ............................192
TIP CLEANING SOLUTION...................................................................................................................192
SPECIAL WASHING SOLUTION FOR MAINTENANCE ACCORDING TO NEED..............................192
SPECIAL WASHING SOLUTION FOR TURBIDIMETRIC TECHNIQUES WITH LATEX.....................192
DISINFECTING SOLUTION ..................................................................................................................192
17 TROUBLESHOOTING...............................................................................................................................192
INTRODUCTION....................................................................................................................................192
CHEMICAL PROBLEMS........................................................................................................................194
High results ....................................................................................................................................195
Low Results....................................................................................................................................196
Erratic Results................................................................................................................................196
Only one affected sample for all of the methods............................................................................197
Only one affected method for all of the samples............................................................................198
INSTRUMENTAL PROBLEMS..............................................................................................................199
Connections and supplies..............................................................................................................199
Diluter.............................................................................................................................................200
Washer...........................................................................................................................................200
Sample/reagent probe....................................................................................................................200
Reaction Cuvettes Tray..................................................................................................................201
Sample/Reagent Tray ....................................................................................................................201
Software .........................................................................................................................................201
HARDWARE MESSAGES.....................................................................................................................202

High Technology, Inc.
109 Production Road,
Walpole MA 02081 USA
Document Number
OM-E-FC-360-30
Revision Level
Rev. 3
Prepared by
J.S. Bolio
Approved by
S. Titov
Effective Date
8/15/2016
Operator’s Manual: HTI BioChem FC-360
HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 1 of 222
INTENDED USE
BioChem FC-360 is a photometric analyzer for clinical chemistry, it is meant to perform automated analytic
procedures for “in vitro” diagnosis.
Terms of use
1. The instrument must be installed by trained personnel.
2. This instrument is Class 1, Type b, IPX0.
3. The instrument must be used by trained personnel
4. Operation room requirements: Room temperature 20-25ºC; Humidity: 20- 85% (no condensation).
5. The instrument must be connected to a supply line according to current national regulations.
6. This instrument must not be used for purposes other than the ones it has been built for.
7. After switching on the instrument, wait 10 minutes before beginning analysis.
8. After powering off, wait at least 20 seconds before restarting.
9. If line variations are higher than 10%, a ferroresonant voltage regulator or a 1500 VA uninterruptible power
supply (UPS) is recommended.
10. Read the entire User’s Manual before using the instrument
11. The laboratory must count on a special residues collection service, to handle wastes.
12. Do not discard the analyzer, neither its accessories, along with domestic residues. Check the local terms for
its correct elimination. Is the user’s responsibility to deliver the analyzer in the indicated pickup point for
recycling of electric and electronic devices, otherwise get in contact with HTI or its authorized agent to
proceed to its removal in a safe and ecological way.
13. Use only expendables and spare parts provided by HTI or its authorized agent.
14. If any failure occurs, contact your local authorized technical service dept., or contact HTI.
Precautions
Electrical Risks
As with any electronic equipment, electric shock is always a potential threat. Extreme caution should be used
when working around the instrument to avoid contact with any electrical wire or components. DO NOT attempt to
work in any electronic compartment while the power is ON.
Mechanical Risks
Keep lids closed when the instrument is working.
Do not touch mechanical arms or other moving parts while the instrument is working.
Do not wear rings, bracelets, necklaces, etc. as they may get caught in operating mechanical systems.
Do not try to change or touch sample tubes, reagents, etc. when the instrument is running to prevent breakage
and/or an accident when the Reagent Sample Tray moves.
Make sure that the instrument is paused to add reagents, samples, etc.

High Technology, Inc.
109 Production Road,
Walpole MA USA 02081
Document Number
OM-E-FC-360-30
Revision Level
Rev. 3
Prepared By
J.S. Bolio
Approved By
S. Titov
Effective date
8/15/2016
Operator’s Manual: HTI BioChem FC-360
Page 2 of 217 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL
Chemical risks
Always wear protective apparel when operating the analyzer (gloves, safety glasses, etc.). Follow specific
recommendations on the bottles of each reagent or washing solution.
Read safety information of materials provided by manufacturers to be aware of possible danger and to learn how
to prevent it.
Biological risks
Rings and long nails can easily break gloves and increase exposure to biological risks. Always treat samples and
reagents as potentially infectious.
Waste and waste deposits must be treated as toxic and biologically hazardous. Handle them and eliminate them
in accordance with routine laboratory protocols.
Follow in force standards given by local sanitary authority.
Eye risks
Do not look straight at barcode detector light beams.
Do not look straight at the light source of spectrophotometers since they can emit ultraviolet rays.
Warnings about the instrument and laboratory practices
The use of calibrators is recommended; refer to reagent manufacturer instructions for specific calibration
instructions.
Symbols used in the manual and the instrument
Warning
Ground Connection
Manufacturing Date
Consult instructions for use
Biological risk
Fuse
This symbol denotes the Catalog number