Diamond SmartLyte User manual

ECO 9085 SOP05-5038F Rev.05 Effective Date: 12/06/18 Page 2 of 81
SMARTLYTE ELECTROLYTE ANALYZER is a Registered Trademark of Diamond Diagnostics Inc.
The Diamond Diagnostics SMARTLYTE analyzer is for In Vitro Diagnostic use.
Diamond Diagnostics Inc
333 Fiske Street
Holliston, MA 01746
Diamond Diagnostics Kft
Óradna Street 6
1044 Budapest Hungary
 2009 SMARTLYTE ELECTROLYTE ANALYZER. All rights reserved.
Registered in the United States Patent and Trademark Office
The information in this manual was correct at the time of printing. However, Diamond
Diagnostics Inc continues to improve products and reserves the right to change the
specifications, equipment, and maintenance procedures at any time without notice.
If the system is used in a manner differently than specified by Diamond Diagnostics Inc., the
protection provided by the equipment may be impaired. See warning and hazard statements.

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Important Information!
This Service Manual contains important warnings and safety information to be observed by the user.
This instrument is only intended for one area of application which is described in the instructions. The
most important prerequisites for application, operation and safety, are explained to ensure smooth
operation. No warranty or liability claims will be covered if the instrument is applied in areas other
than those described or if the necessary prerequi
sites and safety measures are not observed.
The instrument is only to be operated by qualified personnel capable of serving these prerequisites.
Only accessories and supplies either delivered by or approved by DIAMOND are to be used with the
instrument.
Due to the operating principle of the instrument, analytical accuracy not only depends on correct
operation and function, but also upon a variety of external influences beyond the manufacturer’s
control. Therefore, the check results from this instrument must be carefully examined by an expert,
before further measures are taken based on the analytical results.
Instrument adjustment and maintenance with removed covers and connected power mains are only to
be performed by a qualified technician who is aware of the dangers involved.
Instrument repairs are only to be performed by the manufacturer or qualified service personnel.
For a detailed service training video for your SmartLyte Analyzer, please visit:
http://www.diamonddiagnostics.com/video/video_SmartLyte.htm
Symbol Explanation
Attention symbol - Refer to the Operator's Manual or Service Manual for further
instructions. This symbol is located on the inside of the instrument.
Type B instrument symbol - An instrument of the B type falls under safety
categories I, II, or III, or has an internal power supply providing the required
insulation against discharge current and reliable ground connections.
Important Information!

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Operating Safety Information
• This instrument falls under Safety Category I.
• This instrument is a Class B instrument.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference's, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
Warning: Changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user's authority to operate the equipment.
Note: This equipment has been checked and found to comply with the limits for a Class
B
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to
provide
reasonable protection against harmful interference in a residential installation. This equipment
generates, uses, and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference
to radio communication.
However, there is no guarantee that interference will not
occur in a particular installation. If this
equipment does not cause harmful interfer ence to radio or television reception, which can be
determined by turning the equip ment 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 antenna
• Increase the separation between the equipment and receiver
• Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
• Consult the dealer or an experienced radio TV technician for help
Caution:
•
The instrument is designed as a conventional device (closed, not waterproof type).
• Do not operate the instrument in an explosive environment or in the vicinity of explosive
anesthetic mixtures containing oxygen or nitrous oxide.
• This instrument is suitable for continuous operation.
•
The power plug is to be plugged into a ground socket only. When using an extension cord, make
sure that it is of the proper size and is properly grounded.
• Any breakage of the ground lead inside or outside the instrument or a loose ground
connection can cause a hazardous condition when operating the instrument. Intentional
disconnection of the grounding is not permitted.
•
When replacing the fuses, make sure that they are of the same type and rating as the
original fuses. Never use repaired fuses or short-circuit the fuse holders.
Operating Safety Information

Table of Contents
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1. Introduction ..................................................................................................................................................... 6
2. General Description .......................................................................................................................................... 7
2.1. Reported Configurations ........................................................................................................................... 7
2.2. Operating Configurations .......................................................................................................................... 7
3. Software Operation ......................................................................................................................................... 10
3.1. Software Operation - SMARTLYTE....................................................................................................... 10
3.2. Service Menu .......................................................................................................................................... 27
4. Description of Modules ................................................................................................................................... 32
4.1. Mechanical Assemblies........................................................................................................................... 32
4.1.1. Front Door Assembly...................................................................................................................... 32
4.1.2. Aspiration Assembly....................................................................................................................... 33
4.1.3. Electrode Tray Assembly................................................................................................................ 34
4.1.4. Peristaltic Pump Rotor CN-A4014 ................................................................................................. 34
4.1.5. Peristaltic Pump Motor CN-A4012 ................................................................................................ 35
4.1.6. Solenoid Valve Assembly............................................................................................................... 36
4.1.7. Printer Assembly CN-A4020/CN-A4060 ....................................................................................... 38
4.1.8. Power Supply Subassembly CN-A4019 ......................................................................................... 39
4.1.9. CPU Board CN-A4053/CN-A4061 ................................................................................................ 40
4.1.10. RFID Board CN-A4054 .............................................................................................................. 41
4.1.11. Valve Board CN-A4018.............................................................................................................. 42
4.1.12. Display Board CN-A4017/CN-A4059........................................................................................ 42
4.2. Fluid Pack ............................................................................................................................................... 43
4.2.1. Standard A ...................................................................................................................................... 43
4.2.2. Standard B and C ............................................................................................................................ 43
4.2.3. Reference Solution.......................................................................................................................... 43
4.2.4. Waste Liquids ................................................................................................................................. 43
4.2.5. Pinch Valve Tubing Set, AV-BP5193D ......................................................................................... 45
4.3. Electronics .............................................................................................................................................. 47
4.3.1. CPU Board ...................................................................................................................................... 48
4.3.2. Valve Board CN-A4018 ................................................................................................................ 50
4.3.3. Display Board CN-A4017/CN-A4059............................................................................................ 50
4.3.4. Graphic Printer CN-A4060 ............................................................................................................. 51
5. Maintenance and Troubleshooting .................................................................................................................. 52
5.1. Maintenance............................................................................................................................................ 52
5.2. Error Messages and Troubleshooting ...................................................................................................... 53
6. Adjustments .................................................................................................................................................... 61
6.1. Sample Sensor Adjustment ..................................................................................................................... 61
6.2. Temperature Adjustment......................................................................................................................... 62
6.3. Display, Contrast and Backlight Adjustment........................................................................................... 63
7. Illustrated Parts List ....................................................................................................................................... 64
8. Interface Specifications .................................................................................................................................. 69
8.1. Interface Information............................................................................................................................... 69
8.2. Example Data String Information............................................................................................................ 70
8.3. Example Data String Information............................................................................................................ 71
9. SMARTLYTE Schematics ............................................................................................................................... 76
9.1. CPU Board.............................................................................................................................................. 76
9.2. Printer ..................................................................................................................................................... 80
9.3. Display.................................................................................................................................................... 81
9.4. Valve....................................................................................................................................................... 81

1 Introduction
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1. Introduction
The Service Manual for the SMARTLYTE Electrolyte Analyzer contains the technical information
needed to ensure easy fault identification. This
manual is intended to be complementary to the
Operator's Manual where
detailed instructions for operation, maintenance and troubleshooting are
provided.
As for all clinical instrumentation, a thorough understanding of the principles of operation is
prerequisite to attempting service of this product. Training
along with experience will enhance the
use of this manual.
Service and repair of the SMARTLYTE analyzer should be performed only by qualified repair
technicians. Care should be taken when removing the covers as hazardous voltages are exposed.
Use only accepted electronic check procedures and static protection when replacing and handling
all electronic parts.
This manual is divided into 9 chapters to facilitate location of technical information. Chapter 2
provides specifications and operating configuration information. Chapter 3 includes flow charts for
all system functions and detailed operation of system check procedures. In Chapter 4, all
mechanical, fluidic and electronic assemblies are described. Chapter 5 outlines routine maintenance
and troubleshooting procedures. Chapter 6 includes electronic adjustments and Chapter 7 provides
the system block diagram and all circuit schematic diagrams and wiring interconnection
information. In Chapter 7, part identification, location and description is provided by the illustrated
parts list. Finally, in Chapter 8 interface specifications are provided for the RS232 output.

2 General Descriptions
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2. General Description
Specifications
2.1.Reported Configurations
Measuring Range Resolution
Whole Blood
Serum
Plasma
Sodium Na
+
40 - 200 mmol/L 0.1 mmol/L
Potassium K
+
1.5 -15 mmol /L 0.01 mmol/L
Chloride Cl
-
50 - 200 mmol/L 0.1 mmol/L
Calcium Ca
++
0.3 - 5.0 mmol/L 0.01 mmol/L
Lithium Li
+
0.2 – 5.5 mmol/L 0.001 mmol/L
Urine
Sodium Na+ 1 - 300 mmol/L 1.0 mmol/L
Potassium K+ 5 - 120 mmol/L 0.1 mmol/L
(60 - 120 mmol/L w. addit. dilution)
Chloride Cl- 1 - 300 mmol/L 1.0 mmol/L
Calcium and Lithium are not measured in urine samples.
2.2.Operating Configurations
Sample type Whole blood, serum, plasma, urine
Sample device Syringe, sample cup, collection tube
Sample size
95 uL
Analysis time 50 seconds
Sample rate 60 per hour

2 General Descriptions
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Measurement
Sodium (Na
+
) sensor Ion-selective, flow-through, glass capillary electrode
Potassium (K+) sensor Ion-selective, flow-through, liquid membrane electrode
Chloride (Cl-) sensor Ion-selective, flow-through, liquid membrane electrode
Calcium (Ca++) sensor Ion-selective, flow-through, liquid membrane electrode
Lithium (Li+) sensor Ion-selective, flow-through, liquid membrane electrode
Reference System Open liquid junction, flow-through electrode
Calibration Fully automatic
1 point with each sample
2 point every 4 hrs (Lithium, 3 point)
Standby Suspends Calibrations
Warm-up time 1 minute
Temperature Room temperature, 15 - 32° C, 60 - 90° F
Humidity Maximum 85% relative humidity, non-condensing
Data management Quality Control memory storage, 3 levels, 500 values each;
calculation of mean, standard deviation, and coefficient of
variation (CV)
Samples, 1000 measurements
Diagnostic Programs User-controlled diagnostics, YES/NO operation via the display or
Keyboard
Electronics Microprocessor-controlled
Display LCD dot-matrix, 2 line, and 16 characters per line
Printer Integral thermal printer, 16 character width

2 General Descriptions
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Interface RS232C Serial Port,
USB Ports, 2
for Keyboard (provided) and Barcode Scanner (Optional)
Electrical requirements
100 - 240 V, 50/60 Hz,
1.4 A max.
Self-adjusting
Nominal power
Consumption
50 W
Dimensions
Height 12.2";
335mm
Width
12.4"; 315m
Depth
12.0"; 295mm
Weight approx. 13 lbs; 6kg
Classifications
Safety category I B (according to EN 60601-1, IEC 601-1)
Device type
Mode of operation Continuous operation
Protection classification IP 20
Explosion protection T
he device is not designed for operation in explosive
environments.
Approvals
CSA, IEC 1010 (TUV/GS), CE, FCC Class B
Data subject to change without notice. Technical information is supplied for general
informational purposes only.

3 Software Operation
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3. Software Operation
3.1.Software Operation - SMARTLYTE
Software operation of the SMARTLYTE analyzer can be accessed by YES/NO selection on the
analyzer front panel or through the function keys in the keyboard. The following flow chart
diagrams are provided to identify operating sequences of the SMARTLYTE Analyzer:
1. Overall Program Operating Flow
2. Main Menu
3. Measurement Sequence
4. Print Reports Menu
5. QC/Standard/Dialysate/Urine Sample Menu
6. Maintenance Menu
7. Operator Settings Menu
8. Instrument Settings Menu
9. Service Menu
10. Calibration Sequence
The SERVICE MENU is also provided with a more detailed description of each
check configurations for use in checking instrument subassemblies.

3 Software Operation
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1. OVERALL FLOW

3 Software Operation
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2. MAIN MENU - HUMAN

3 Software Operation
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3. MEASUREMENT SEQUENCE

3 Software Operation
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4. A. PRINT REPORTS-SAMPLES

3 Software Operation
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4.B PRINT REPORTS – QC ETC.

3 Software Operation
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5. QC-STD-DIALYSATE-URINE SAMPLE

3 Software Operation
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6. MAINTENANCE

3 Software Operation
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7.A. OPERATOR SETTINGS H TO V

3 Software Operation
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7.B. OPERATOR SETTING H TO V

3 Software Operation
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8.A. INSTRUMENT SETTINGS QC