Diamond SmartLyte Plus User manual

ECO 9099 SOP05-5090F Rev.00 Effective Date: 12/20/18 Page 2 of 58
SMARTLYTE® PLUS ELECTROLYTE ANALYZER is a Registered Trademark of Diamond Diagnostics Inc.
The Diamond Diagnostics SMARTLYTE®PLUS analyzer is for In Vitro Diagnostic use.
Diamond Diagnostics Inc
333 Fiske Street
Holliston, MA 01746
Diamond Diagnostics Kft
6 Oradna Street
1044 Budapest Hungary
2009 SMARTLYTE®PLUS 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.

ECO 9099 SOP05-5090F Rev.00 Effective Date: 12/20/18 Page 3 of 58
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 prerequisites 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 PLUS Analyzer, please visit:
http://www.diamonddiagnostics.com/video/video_SMARTLYTE PLUS.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!

ECO 9099 SOP05-5090F Rev.00 Effective Date: 12/20/18 Page 4 of 58
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 interference to radio or television
reception, 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 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 handling electronic components such as – CPU, RFID PCB, Interface-PC, and printer PCB
– ESD (Electronic Sensitive Device) protection is recommended. ESD mats should be used when
handling and working with these electronic components. ESD packaging is recommended for
transportation.

Table of Contents
ECO 9099 SOP05-5090F Rev.00 Effective Date: 12/20/18 Page 5 of 58
1. Introduction ................................................................................................................................................. 7
1.1. General Description............................................................................................................................ 8
1.1.1. Measurement .................................................................................................................................. 8
1.1.2. Operating Configurations .............................................................................................................. 8
1.2. Software Operation........................................................................................................................... 10
1.3. Description of Modules.................................................................................................................... 11
1.3.1. Mechanical Assemblies............................................................................................................... 11
1.3.1.1. Front Door Assembly ............................................................................................................... 11
1.3.1.2. Rear Panel Subassembly........................................................................................................ 14
1.3.1.3. Power Supply Subassembly ................................................................................................... 15
1.3.1.4. Power Inlet Module Subassembly ......................................................................................... 16
1.3.1.5. CPU Board (CN-A4405) .......................................................................................................... 17
1.3.1.6. Aspiration Assembly................................................................................................................. 21
1.3.1.7. Electrode Tray Assembly ........................................................................................................ 26
1.3.1.8. Peristaltic Pump Rotor (CN-A4014)....................................................................................... 29
1.3.1.9. Peristaltic Pump Motor............................................................................................................. 30
1.3.1.10. Solenoid Valve System ........................................................................................................ 31
1.3.1.11. Printer Assembly (CN-A4060)............................................................................................. 34
1.3.1.12. RFID Board (CN-A4054)...................................................................................................... 36
1.3.1.13. Valve Board (CN-A4018)..................................................................................................... 36
1.3.1.14. Display Board (CN-A4406).................................................................................................. 38
1.3.1.15. Interface PC........................................................................................................................... 39
1.4. Fluidic Modules.................................................................................................................................. 40
1.4.1. Standard A..................................................................................................................................... 40
1.4.2. Standard B and C......................................................................................................................... 40
1.4.3. Reference Solution ...................................................................................................................... 40
1.4.4. Waste Liquids ............................................................................................................................... 40
1.4.5. Fluidic Flow Path .......................................................................................................................... 41
1.4.6. Pinch Valve Tubing Set (AV-BP5193) ...................................................................................... 42
1.4.7. Fluidic Diagram............................................................................................................................. 45
1.5. Electronics .......................................................................................................................................... 46
1.5.1. Block Diagram of SmartLyte® Plus........................................................................................... 46
1.5.2. CPU Board .................................................................................................................................... 46
1.5.3. Power Circuits............................................................................................................................... 48
1.5.4. Microcontroller .............................................................................................................................. 48
1.5.5. EMF and Noise Shielding ........................................................................................................... 48
1.5.6. Fluid Pack Sensor ........................................................................................................................ 48
1.5.7. Valve Drivers................................................................................................................................. 49
1.5.8. Pump Motor Driver....................................................................................................................... 49
1.5.9. Input Amplifiers............................................................................................................................. 49
1.5.10. Temperature Sensor circuit..................................................................................................... 49
1.5.11. Analog Channel and A/D Converter ...................................................................................... 49
1.5.12. CPU board Connector ............................................................................................................. 49
1.5.13. Valve Board ............................................................................................................................... 49
1.5.14. Display Board............................................................................................................................ 50
1.5.15. Printer ......................................................................................................................................... 50
1.5.16. Shielding and Grounding......................................................................................................... 50
1.5.17. Interface PC............................................................................................................................... 50
2. Scheduled Maintenance......................................................................................................................... 51

Table of Contents
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2.1. Daily ...................................................................................................................................................... 51
2.2. Weekly Maintenance......................................................................................................................... 51
2.3. Monthly Maintenance ....................................................................................................................... 51
2.4. Six Month Maintenance ................................................................................................................... 51
2.5. Annual Preventive Maintenance.................................................................................................... 51
3. Troubleshooting ....................................................................................................................................... 52
3.1. Error Messages and Troubleshooting......................................................................................... 52
4. Parts List .................................................................................................................................................... 58
4.1. Consumables...................................................................................................................................... 58
4.2. Analyzer Parts for Repair ................................................................................................................ 58

1 Introduction
ECO 9099 SOP05-5090F Rev.00 Effective Date: 12/20/18 Page 7 of 58
1. Introduction
The Service Manual for the SmartLyte®Plus 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®Plus 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 4 chapters to facilitate location of technical information. Chapter 1 includes all
mechanical, fluidic and electronic assemblies are described. Chapter 2 outlines routine maintenance and
troubleshooting procedures. Chapter 3 includes troubleshooting, including error messages. Finally,
Chapter 4 includes part identification.

1 Introduction
ECO 9099 SOP05-5090F Rev.00 Effective Date: 12/20/18 Page 8 of 58
1.1. General Description
1.1.1. Measurement
SampleTypes: Whole Blood, Serum, Plasma, QC Material, Aqueous
Reported Parameters Range Measurement Resolution
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
Sample Type: Urine
Reported Parameters Range Measurement Resolution
Sodium, Na+1 - 300 mmol/L 1 mmol/L
Potassium, K+5 - 120 mmol/L 0.1 mmol/L
Chloride, Cl-50 - 200 mmol/L 1 mmol/L
Calcium and Lithium are not measured in urine samples.
1.1.2. Operating Configurations
Sample type Whole blood, serum, plasma, urine, QC material, Aqueous samples
Sample device Syringe, sample cup, collection tube
Sample size 95 uL
Analysis time 28 seconds
Sample rate 128 per hour
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 calomel electrode
Calibration Fully automatic
1 point with each sample
2 point every 4 hrs (Lithium, 3 point)
Warm-up time 2 minutes
Temperature Room temperature, 15 - 32° C, 60 - 90° F
Humidity Maximum 85% relative humidity, non-condensing

1 Introduction
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Data management Quality Control memory storage, 3 levels, 500+ values each;
Calculation of mean, standard deviation, coefficient of variation (CV)
Samples, 10000+ measurements
Diagnostic Programs Tests selected in Diagnostic Menu
Electronics Microprocessor-controlled and Interface-PC
Display Graphical touch screen, 800 x 400 pixels
Printer Integral thermal printer, 16 character width
Interface RS232C Serial Port
4 USB Ports
LAN/Ethernet
Electrical requirements 100 - 240 V, 50/60 Hz,
1.4 A max.
Self-adjusting
Nominal power
Consumption Minimum 10W/hour
Typical 25W/hour
Maximum 35W/hour
Dimensions
Height 335 mm; 13.2"
Width 315 mm, 12.4"
Depth 295 mm; 12.0"
Weight approx. 6kg; 14 lbs;
Classifications
Safety category I
Device Type B (according to EN 60601-1, 6010-2-101)
Mode of operation Continuous
Protection class IP 20
Explosion protection The device is not designed for operation in explosive environments.
Approvals CSA C22.2, EN 61010-1, CE, FCC Class B
Data subject to change without notice. Technical information is supplied for general informational
purposes only.

1 Introduction
ECO 9099 SOP05-5090F Rev.00 Effective Date: 12/20/18 Page 10 of 58
1.2. Software Operation
Software operation of the SmartLyte®Plus analyzer is accessed through the touch screen buttons. There are two
Main Menus from which all functions can be accessed. Through the Operations Menu, the Diagnostics function
can be access to aid in servicing the instrument.
Operations
Figure 1-1 Main Menu
Measurment
Figure 1-2 Measurement Menu