Heska Element DC Manuel utilisateur

Element DC

Veterinary Chemistry Analyzer

product manual

Introduction

Thank you for purchasing the Element DC® Veterinary Chemistry Analyzer

The Element DC is a diagnostic medical device for veterinary hospital use to analyze blood by colorimetric end-point, rate

and ISE tests, using the DRI-CHEM SLIDES.

Before using this equipment, please read this manual carefully to follow the precautions so that you can operate it

correctly.

Keep the manual near the Element DC, so that you can refer to it whenever necessary.

CAUTIONS

1. No part or all of this manual may be reproduced in any form without prior permission.

2. The information contained in this manual may be subject to change without prior

notice.

3. FUJIFILM shall not be liable for malfunctions and damage resulting from installation,

relocation, remodeling, maintenance, and repair done by other than dealers specified

by FUJIFILM.

4. FUJIFILM shall not be liable for malfunctions and damage of FUJIFILM products due

to the use of products of other manufacturers not supplied by FUJIFILM.

5. FUJIFILM shall not be liable for malfunctions and damage resulting from remodeling,

maintenance, and repair using repair parts other than those specified by FUJIFILM.

6. FUJIFILM shall not be liable for malfunctions and damage resulting from negligence of

precautions and operating methods contained in this manual.

7. FUJIFILM shall not be liable for malfunctions and damage resulting from use under

environment conditions outside the range of conditions required for proper use of this

product, such as power supply, installation environment, etc. contained in this manual.

8. FUJIFILM shall not be liable for malfunctions and damage resulting from natural

disasters such as fires, earthquakes, floods, lightning, etc.

Introduction

Element DC

Veterinary Chemistry Analyzer

SECTION 1: SAFETY USAGE AND HANDLING PRECAUTIONS

1.1 Deﬁnition of Speciﬁc Safety Precautions....................................................................................................................................................................1

1.2 Precautions Before Operating This Equipment......................................................................................................................................................1

1.3 Biohazards and Disposal.......................................................................................................................................................................................................2

1.4 Explosive Hazards......................................................................................................................................................................................................................2

1.5 Electrical Hazards ......................................................................................................................................................................................................................2

1.6 Electromagnetic Compatibility (EMC)..........................................................................................................................................................................3

1.7 Moving Parts ................................................................................................................................................................................................................................3

1.8 Installation Site Requirements..........................................................................................................................................................................................4

1.9 Test Results for Diagnosis.....................................................................................................................................................................................................4

1.10 DRI-CHEM SLIDES......................................................................................................................................................................................................................5

1.11 QC Card System.........................................................................................................................................................................................................................7

1.12 Handling Samples.....................................................................................................................................................................................................................7

1.13 Sampler Cover.............................................................................................................................................................................................................................7

1.14 Diluents and Reference Fluid.............................................................................................................................................................................................7

1.15 DRI-CHEM AUTO TIPS, Sample Tubes, and DRI-CHEM MIXING CUPS.......................................................................................................8

1.16 Light Source Lamp...................................................................................................................................................................................................................8

1.17 Recording Paper ........................................................................................................................................................................................................................8

1.18 Warning Labels...........................................................................................................................................................................................................................9

SECTION 2: COMPONENT NAMES AND FUNCTIONS

2.1 Component Names..............................................................................................................................................................................................................10

2.2 Names and Functions of Touch Panel Display.....................................................................................................................................................12

2.2.1 TOP Dialogue .....................................................................................................................................................................................................12

2.2.2 Test Preparation Dialogue..........................................................................................................................................................................13

2.2.3 Mode Function Dialogue............................................................................................................................................................................17

2.2.4 Result Search Dialogue................................................................................................................................................................................17

2.2.5 Help Dialogue....................................................................................................................................................................................................19

2.3 Names and Functions of Screen Keyboard............................................................................................................................................................20

2.3.1 Ten-Key Input Dialogue...............................................................................................................................................................................20

2.3.2 Alphanumeric Input Dialogue ................................................................................................................................................................21

Table of Contents

Element DC

Veterinary Chemistry Analyzer

SECTION 3: PRINCIPLES OF OPERATION

3.1 Slide Loading............................................................................................................................................................................................................................25

3.2 Sample Loading......................................................................................................................................................................................................................25

3.3 Sampling and Spotting......................................................................................................................................................................................................25

3.4 Incubation ..................................................................................................................................................................................................................................25

3.5 Photometer and Potentiometer Readout...............................................................................................................................................................25

3.6 Disposal of Consumables..................................................................................................................................................................................................26

3.7 Preparations...............................................................................................................................................................................................................................26

3.7.1 List for Daily Maintenance Before Use................................................................................................................................................26

3.7.2 Preparations before Turning the Power On (Daily Maintenance before Use #1).....................................................26

3.7.3 Turning the Power On (Daily Maintenance before Use #2)...................................................................................................27

3.7.4 List for Daily Maintenance after Use....................................................................................................................................................29

3.7.5 Turning the Power Oﬀ (Daily Maintenance after Use)..............................................................................................................29

3.7.6 Sample Racks......................................................................................................................................................................................................30

3.7.7 Producing Samples Using Sample Tubes.........................................................................................................................................31

3.7.8 QC Card System................................................................................................................................................................................................32

3.8 Measurement...........................................................................................................................................................................................................................33

3.8.1 Basic Measurements (excluding ISE tests and tests that require dilution)...................................................................33

3.8.2 Usage of the WORK LIST Button.............................................................................................................................................................36

3.8.3 ISE Tests..................................................................................................................................................................................................................38

3.8.4 Tests that Require Dilution.........................................................................................................................................................................39

3.8.5 Setting Slides......................................................................................................................................................................................................42

3.8.6 Rerunning Tests ................................................................................................................................................................................................43

3.9 Sample Barcode Reader.....................................................................................................................................................................................................44

3.9.1 Operating Procedures...................................................................................................................................................................................45

3.10 Editing Sample No. and Sample ID.............................................................................................................................................................................46

SECTION 4: PERIODIC MAINTENANCE

4.1 User Daily/Periodic Maintenance.................................................................................................................................................................................48

4.2 Cleaning the Air Filters........................................................................................................................................................................................................48

4.2.1 Cleaning Procedures .....................................................................................................................................................................................48

4.3 Cleaning the Incubator, Spotting Part and ISE Unit .........................................................................................................................................49

4.4 Cleaning the Slide Reader ................................................................................................................................................................................................54

4.4.1 Cleaning Procedure........................................................................................................................................................................................54

4.5 Replacing the Recording Paper.....................................................................................................................................................................................55

4.5.1 Replacement Procedure..............................................................................................................................................................................55

4.6 Replacing and Cleaning the Light Source Lamp ...............................................................................................................................................56

4.6.1 Replacement and cleaning procedure..............................................................................................................................................56

4.7 Inspecting and Replacing the Sampler O-ring....................................................................................................................................................58

4.7.1 Inspecting the Sampler O-ring...............................................................................................................................................................58

4.7.2 Replacing the Sampler O-ring.................................................................................................................................................................66

SECTION 5: TROUBLESHOOTING

5.1 Error Indications......................................................................................................................................................................................................................61

5.1.1 Error Codes Table.............................................................................................................................................................................................61

5.1.2 Printout Indications Table...........................................................................................................................................................................63

5.2 Troubleshooting.....................................................................................................................................................................................................................65

5.2.1 Startup Errors......................................................................................................................................................................................................65

5.2.2 Display or Printer Trouble ...........................................................................................................................................................................65

5.2.3 Slide Reading Error .........................................................................................................................................................................................65

5.2.4 Sampler Errors....................................................................................................................................................................................................66

5.2.5 Photometer Errors...........................................................................................................................................................................................68

5.2.6 Transfer Errors.....................................................................................................................................................................................................69

5.2.7 Temperature Control Errors.......................................................................................................................................................................69

5.2.8 Circuit Board Malfunction ..........................................................................................................................................................................70

5.2.9 QC Card/DI Card Read Error......................................................................................................................................................................71

5.2.10 Slide Loading Errors........................................................................................................................................................................................71

5.2.11 Errors Related to ISE Tests...........................................................................................................................................................................71

5.2.12 Errors Related to Data Communication or Sample Barcode Reader...............................................................................73

5.2.13 Other Errors.........................................................................................................................................................................................................74

SECTION 6: MODE SETTINGS AND FUNCTIONS

6.1 Mode Setting Procedure and Description .............................................................................................................................................................75

6.1.1 Mode Setting Procedure.............................................................................................................................................................................75

6.1.2 How to Select Each Mode..........................................................................................................................................................................76

6.2 Control Mode <Normal>..................................................................................................................................................................................................77

6.2.1 Execution of the Control Mode..............................................................................................................................................................77

6.3 Date & Time Settings <Normal> ..................................................................................................................................................................................77

6.4 Display Brightness <Normal>........................................................................................................................................................................................77

6.5 Buzzer Volume <Normal> ................................................................................................................................................................................................78

6.5.1 Error Sound..........................................................................................................................................................................................................78

6.5.2 Test End Sound .................................................................................................................................................................................................79

6.6 Lamp Conﬁguration <Normal>....................................................................................................................................................................................80

6.7 Display Information <Normal>.....................................................................................................................................................................................82

6.7.1 Error log.................................................................................................................................................................................................................82

6.7.2 Display Temperature & Humidity...........................................................................................................................................................83

6.7.3 Lot Information.................................................................................................................................................................................................83

6.7.4 DI Card Information........................................................................................................................................................................................84

iii

6.8 Basic/External I/F Settings <Admini.>.......................................................................................................................................................................86

6.8.1 Language Setting............................................................................................................................................................................................86

6.8.2 Date Format Setting.......................................................................................................................................................................................87

6.8.3 Host I/F Settings...............................................................................................................................................................................................88

6.8.4 Barcode Reader.................................................................................................................................................................................................92

6.9 Display Settings <Admini.>.............................................................................................................................................................................................94

6.9.1 Unit Conversion................................................................................................................................................................................................94

6.9.2 Display Method for Outside of Measurement Range...............................................................................................................95

6.9.3 Reference Interval Settings........................................................................................................................................................................97

6.9.4 Result Display Setting................................................................................................................................................................................101

6.9.5 Sample No./ID Settings.............................................................................................................................................................................102

6.9.6 Work List Selection Setting.....................................................................................................................................................................103

6.10 Coeﬃcients/Test Settings <Admini.>.....................................................................................................................................................................103

6.10.1 Correlation Coeﬃcients............................................................................................................................................................................104

6.10.2 Lot Compensation Coeﬃcients...........................................................................................................................................................108

6.10.3 Dilution Factor................................................................................................................................................................................................111

6.10.4 Spotting Count ..............................................................................................................................................................................................112

6.10.5 Print Sheets of Test Results .....................................................................................................................................................................112

SECTION 7: OTHER FUNCTIONS

7.1 Data Communication.......................................................................................................................................................................................................115

SECTION 8: SPECIFICATIONS/CONSUMABLES

8.1 Speciﬁcations and Standard Accessories.............................................................................................................................................................117

8.1.1 Speciﬁcations..................................................................................................................................................................................................117

8.1.2 Standard Accessories .................................................................................................................................................................................118

8.2 Consumables and Optional Accessories..............................................................................................................................................................118

8.2.1 Consumables ..................................................................................................................................................................................................118

8.2.2 Optional Accessories..................................................................................................................................................................................119

SECTION 9: GLOSSARY.........................................................................................................................................................................................................................121

Safe Usage and Handling Precautions

This section contains safety precautions which must be followed for the safe operation of the Element DC® Veterinary

Chemistry Analyzer.

Before using this equipment, please read this chapter carefully and follow the precautions given, so that you can operate it

correctly.

1.1 Definition of Specific Safety Precautions

Speciﬁc safety precautions are noted by the terms WARNING, CAUTION, IMPORTANT, and additional information by NOTE.

The respective meanings are as follows:

WARNING

Indicates hazardous situations that may lead to serious injury, even death or the transmission of infectious agents if

the precaution is not followed.

CAUTION

Indicates hazardous situations that may lead to minor or moderate injury or physical damage if the caution is not

followed.

IMPORTANT

Indicates improper handling that could have an adverse effect on the accuracy of the measurement values if the

precaution is not followed.

Indicates procedures requiring special attention, instructions that must be followed, supplementary explanations, etc.

1.2 Precautions Before Operating This Equipment

CAUTION

Before using this equipment, please read this Instruction Manual carefully so that you can operate the equipment

correctly.

CAUTION

Whenever you operate this equipment, be sure to observe the precautions described in this manual. Failure to do so

may subject you to injuries, cause property damage, or produce incorrect test results.

CAUTION

This equipment is only to be operated by personnel appropriately trained for its intended use and correct operation.

CAUTION

The operators must be appropriately trained for the usage of the key (sampler cover lock) to follow the usage and its

cautionary statements. Refer to Section 1.13, Sampler Cover.

CAUTION

Do not remodel the Element DC. Otherwise, the safety will not be guaranteed.

Section 1: Safe Usage and Handling Precautions

Element DC

Veterinary Chemistry Analyzer

CAUTION

In the mode functions described in Section 6, there are 2 kinds of modes: one is the administrator mode, which

can only be operated by administrators; another is the normal mode, which can be operated by normal operators.

The important mode functions, which affect test results such as correlation coefficient settings, can only be

operated in the administrator mode. The administrator modes must be operated only by the administrators who

have the responsibility for the use of the analyzer. Inputting a password in the password input dialogue allows the

administrators to operate the administrator modes.

1.3 Biohazards and Disposal

WARNING

As used (contaminated) consumables (e.g., DRI-CHEM SLIDES, DRI-CHEM AUTO TIPS, DRI-CHEM MIXING CUPS and

sample tubes) and contaminated swabs or cloths used for cleaning the equipment are infectious waste, process

the waste correctly in compliance with any applicable regulations in your country, such as by incineration, melting,

sterilization or disinfection.

WARNING

When discarding the Element DC body that may be contaminated with blood samples, be sure to process it correctly

in compliance with any applicable regulations in your country because it must never be disposed of as a general

waste.

WARNING

When handling samples (blood) and performing maintenance (cleaning the analyzer), always follow biohazard

procedures (e.g., wearing gloves, lab coat, and safety goggles), referring to the sample handling rules of your facility.

If any part of the body comes in contact with samples, immediately rinse the contaminated body part thoroughly

under running water and then use ethyl alcohol as a disinfectant. Seek medical assistance if necessary.

WARNING

Do not touch used slides and tips with bare hands as this may cause contamination. If any part of the body comes in

contact with contaminated consumables, immediately rinse the contaminated body part thoroughly under running

water and then use ethyl alcohol as a disinfectant. Seek medical assistance if necessary.

WARNING

When samples come into contact with the analyzer components, immediately clean and disinfect the components.

1.4 Explosive Hazards

WARNING

As this equipment is not explosion-proof, be sure not to use flammable and explosive gas around the equipment.

1.5 Electrical Hazards

WARNING

The power supply voltage applied to the equipment is AC100–240V.

To avoid electrical shock, observe the following precautions:

Avoid installation sites where water may splash, etc., on the equipment.

Make sure that the equipment is properly grounded to a protective earth lead for indoor wiring.

Make sure that all cables have been properly connected.

WARNING

Plug the power cable of the equipment into an outlet with a grounding receptacle. If the equipment is not grounded

to a protective earth lead, this may cause electrical shock.

WARNING

When plugging the power cable in or removing it from an outlet, be sure to hold onto the plug body, not just the

cable, to prevent damage to the cable.

WARNING

Do not remove covers or other parts that are secured with screws to avoid electrical shock that may result from

exposure to hazardous voltage, or injury from moving parts.

1.6 Electromagnetic Compatibility (EMC)

NOTE: This equipment conforms to the following EMC requirements:

FCC Part 15 Subpart B:2006, Class A

ICES–003 Issue No. 4, Class A

This is a class A product. In a domestic environment, this product may cause radio interference in which case the user may

be required to take adequate measures.

This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the

FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment

is operated in a commercial environment. This equipment generates and can radiate radio frequency energy and, if not

installed and used in accordance with the instruction manual, may cause harmful interference to radio communications.

Operation of this equipment in a residential area may cause harmful interference in which case the user will be required

to correct the interference at his own expense.

This Class A digital apparatus complies with Canadian ICES–003.

If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment

off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving device.

Increase the separation between the equipment.

Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.

Consult the manufacturer or field service technician for help.

CAUTION

Do not use other devices (such as mobile phone) which generate and can radiate radio frequency energy near the

Element DC. Otherwise, physical damage or malfunction on the Element DC may occur.

1.7 Moving Parts

WARNING

Do not place your hands near the moving part (sampler, slide transfer bar, spotting part) whenever operating the

equipment, including maintenance. Also use care not to get your hands, hair, clothing, or accessories caught in

moving part.

WARNING

During sample processing, ensure the LCD under cover and sampler cover are closed and locked with the key to

prevent injuries and biohazard. If fingers touch the tip which has sample inside, the sample will spill out from the tip

to cause biohazard. When the display reads [Ready to test], the sampler cover can be opened.

1.8 Installation Site Requirements

WARNING

Plug the power cable of the equipment into an outlet with a grounding receptacle. If the equipment is not grounded

to a protective earth lead, this may cause electrical shock.

CAUTION

Avoid the following installation sites:

Places where spills or water leakage may occur.

Places where the equipment is exposed to direct sunlight.

Places near sources of heat such as heaters.

Places where the temperature may drastically change.

Places where the equipment is subject to vibration or its support table is unstable.

1. Install the equipment in the following environmental conditions:

Location: Indoor use

Illumination: Below 6,000 cd/m² (lux) (Below 3,000 cd/m² (lux) when using the sample barcode reader)

Altitude: Up to 2,000 m

Transient overvoltage category: II

Pollution degree: 2

Operating temperature: 59°F to 89°F (15°C to 32°C)

Operating humidity: 30% to 80% RH (no vapor condensation)

2. Use the equipment under the following electrical requirements:

Voltage limit:100−240 V

Frequency: 50−60 Hz

Supply voltage fluctuations: ± 10%

Rated current: 2.5−1.1 A

Phase: Single

Type of protection against electrical shock: CLASS 1 EQUIPMENT

3. Plug the Element DC into an independent AC outlet separate from other devices.

4. Empty space is necessary at least 4 in (10 cm) on the back and the both sides of the equipment (Empty space on the

back is necessary to unplug the power cable connector from the appliance inlet of the equipment).

5. Unplug the equipment from the AC outlet if it will not be used for an extended period of time.

1.9 Test Results for Diagnosis

WARNING

In case that an analyzer malfunction error(s) is (are) displayed (printed) before/during test processing, or warning

indications are printed out along with test results, the test results may NOT be accurate. Refer to Section 5:

Troubleshooting and rerun the tests.

IMPORTANT

Make a diagnosis in a comprehensive manner, considering other relative test results or clinical situation.

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