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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

Содержание SmartLyte Plus

Страница 1: ......

Страница 2: ...ngary 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 m...

Страница 3: ...ect 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 wh...

Страница 4: ...ference 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 con...

Страница 5: ...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...

Страница 6: ...ge 6 of 58 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 ...

Страница 7: ...his 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 di...

Страница 8: ...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 t...

Страница 9: ...ce 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 Prote...

Страница 10: ...tion 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 ...

Страница 11: ...3 Description of Modules 1 3 1 Mechanical Assemblies 1 3 1 1 Front Door Assembly The front door assembly is comprised of the following parts 1 Front Door 2 Plastic Window 3 EMI Window 4 Door Magnets Figure 1 3 Front Door Assembly Front View Front Door Assembly Plastic Window on Front ...

Страница 12: ... when opened will extend beyond and below the work surface 2 Remove the red ground connector from the Right Angle Tab by grasping the red connector and pulling to the left exposing the Right Angle Tab Figure 1 5 Figure 1 5 Door Ground Connector Red 3 Then remove the ground screw external tooth washer right angle tab and hex nut Figure 1 6 Ground Connector EMI Window beneath Plastic Door Magnets Ri...

Страница 13: ...wo layers the EMI window and the plastic window Both can be replaced in the field 1 From the rear side of the door Figure 1 4 gently press the window and snapping the EMI and plastic window out the front side of the door 2 Verify that the copper conductive tape is still adhered to the both the front and back surface of the door 3 Remove adhesive backing from the EMI Window 4 Place the EMI Window f...

Страница 14: ...h Connectors and Power Supply 1 Ensure power is off 2 Disconnect RS232 cable if attached 3 Disengage the 4 screws in the corners of the back case 4 Move the back case a few inches away from the chassis 5 Disconnect cables and wires so that the rear case can be separated from the front case Figure 1 8 Figure 1 9 Connectors and cables on CPU board Interface PC with 4 USB Ports LAN connection Com Boa...

Страница 15: ... Power Supply Subassembly the Rear Panel must be removed first 1 Ensure the power is off 2 Remove the Rear Panel according to Section 1 3 1 2 3 Disconnect the Power Inlet Module Connector Figure 1 10 Figure 1 10 Rear Panel with Power Supply and Main Power Receptacle 4 Remove Ground Cables from Power Inlet Module and left side of Dual Tab 5 Finally remove the four screws securing Blue Ring Connecto...

Страница 16: ...ow the instructions in Section 1 3 1 2 to separate the Rear Panel from the Front Case 2 Remove Ground Wire from the Power Inlet Module Figure 1 13 Rear Panel with Power Inlet Module 3 Turn over the Rear Panel 4 Remove the two screws on the external face of the Rear Panel Figure 1 14 Power Inlet Module Connector Ground Wire Connector Power Inlet Module Side of Dual Tab Connect to Power Inlet Module...

Страница 17: ...U Board CN A4405 The CPU board can be replaced when there is a malfunction ESD precautions should be exercised to prevent damaging the electronic components To remove and replace the CPU 1 First remove the Rear Panel according to instructions in Section 1 3 1 2 to expose the CPU board 2 Once the Rear Panel is removed unplug the Display cable from the CPU board ...

Страница 18: ...de 5 Remove the 6 screws with their plastic washers that hold the CPU board to front case Figure 1 16 circled in red 6 Carefully pull the CPU board off the alignment pin Figure 1 16 circled in white Ensure the RFID board and the printer is not dislodged 7 Handle board carefully so as to not damage the Electrode Pins on the front of the CPU board 8 Each Pin can be removed by pulling the Electrode P...

Страница 19: ...Effective Date 12 20 18 Page 19 of 58 Figure 1 17 Front Case Assembly No CPU Board 9 Lay the board on an ESD mat or packaging Figure 1 18 CPU Board Back Shield Display Cable Connector Valve Board Connector Power Cable Connector RS232 Serial Port ...

Страница 20: ... This will prevent Electrode Pins from being pushed too far into the socket 3 Place board on alignment pin Figure 1 16 4 Check that Electrode Pins are placed in front case without pushing pins into their sockets 5 Also verify RFID board is not dislodged 6 Secure CPU Board to the front case using the screws and plastic washers previously removed Leave screws slightly loose 7 Check that each Electro...

Страница 21: ... the CPU board 9 When all pins are visible tighten all screws without over tightening 1 3 1 6 Aspiration Assembly This module is comprised primarily of two subassemblies the Aspiration Sub Assembly and the Sample Probe Figure 1 21 Aspiration Assembly Sample Probe Fill Port White Sample Probe Holder Block Sample Door Aspiration Sub assembly 5 Electrode Pin Mating Holes ...

Страница 22: ... for easy replacement 1 Sample Probe Assembly AV BP5006D Figure 1 21 2 Aspiration Sub Assembly CN A4010 Figure 1 21 3 Fill Port Sub Assembly AV BP9043D Figure 1 21 Figure 1 22 Sample Probe Assembly AV BP5006D Figure 1 23 Aspiration Subassemlby CN A4010 Figure 1 24 Fill Port Assembly AV BP9043D Intake Tubing Probe Fill Port Holder Sample Door Fill Port ...

Страница 23: ...e sample probe from its position Figure 1 21 It is recommended to replace the Sample Probe each year To replace the Sample Probe assembly 1 Align the bottom of the sample probe in the white Sample Probe holder block and press the replacement assembly into place 2 Press the top of the sample probe near the intake tubing to ensure the probe is completely snapped into the white Sample Probe Holder 3 ...

Страница 24: ...Ethernet connectors must be removed first Figure 1 28 Rear Case with Connectors Power Supply 1 Ensure power is off before proceeding 2 Disconnect RS232 cable if attached 3 Disengage the 4 screws in the corners of the back case 4 Move the back case a few inches away from the chassis 5 Disconnect cables and wires so that the rear case can be separated from the front case Figure 1 29 a Disconnect the...

Страница 25: ...isconnect Figure 1 29 Figure 1 29 Connectors and cables on CPU Board 6 Remove the two rear screws using a hex key Figure 1 29 7 Then remove the front securing screw using the same hex key Figure 1 30 Figure 1 30 Front Hex Screw for Aspiration Sub Assembly 10 Check that the sample intake tubing is disconnected from the sample detector Figure 1 25 11 Disconnect the reagent supply tubing red tag from...

Страница 26: ...Main Operations Menu Maintenance Hold in Maintenance 2 Disconnect the sample sensor cable from the analyzer Figure 1 31 3 Remove the sample intake tubing on the right side of the assembly where the sample sensor is located Figure 1 31 Figure 1 32 Electrode Tray with electrodes installed 4 Unplug the Reference Tubing Connector 5 Disconnect the waste tube green tag from the left side of the electrod...

Страница 27: ...ectrode Tray Towards you 8 Use each hand to press the plastic tabs on the right and left side of the electrode tray assembly towards the center of the tray 9 Slide the Electrode Tray towards you to completely release the tray and remove the assembly from the analyzer Figure 1 34 Figure 1 34 Electrode Tray Locking Tabs The sample sensor on the right and the electrode locking mechanism on the left c...

Страница 28: ...1 Introduction ECO 9099 SOP05 5090F Rev 00 Effective Date 12 20 18 Page 28 of 58 Figure 1 35 Locking Mechanism Installation Figure 1 36 Sample Sensor Installation ...

Страница 29: ...ure 1 37 Peristaltic Pump Rotor on Analyzer To Remove the Rotor 1 Unwind front and back Peri Pump tubing from the Motor shaft Figure 1 38 Figure 1 38 Unwinding Peri Pump Tubing 2 Grasp the Rotor Assembly firmly and pull away from the instrument To install the Rotor Assembly 1 Align the rotor flat interface with the flat on the motor shaft Figure 1 39 Figure 1 39 Peristaltic Pump Rotor Front Tubing...

Страница 30: ... motor 1 Remove the Peristaltic Pump Rotor according to the procedure above Section 1 3 1 8 2 Remove the rear panel and CPU Board as described in Section 1 3 1 2 3 Locate the Pump Motor electrical connector plugged into the valve board Figure 1 40 4 Disconnect the motor connector Figure 1 40 Figure 1 40 Connectors and cables on CPU board Pump Motor 5 On the front of the analyzer remove the four sc...

Страница 31: ...in CN 4155 and the indicator cap CN 4018 The Crimp Pin applies pressure to the tubing to shut off fluid flow The Indicator Cap holds the Crimp Pin in place Figure 1 43 Peristaltic Pump Motor Figure 1 44 Crimp Pin and Indicator There are 5 solenoid valves one each for Standard A A Standard B B Standard C C Reference Solution R and Air V The removal of each solenoid valve is identical Figure 1 45 Cr...

Страница 32: ...rds Figure 1 46 Valve positions 3 Push down on Indicator cap in the direction of the arrow to slide it off the solenoid valve shaft 4 Then remove the Crimp Pin from the solenoid shaft To install the crimp pin and cap the instrument must be on 1 Place the instrument in Hold in Maintenance mode Main Operations Menu Maintenance Hold in Maintenance 2 Access the Check Valve menu in Diagnostic Menu Main...

Страница 33: ...hen finished exit menu by pressing CANCEL To remove the entire Solenoid Valve Sub Assembly 1 First follow the steps above for the removal of the Indicator Cap and Crimp Pin 2 Remove the two screws on each side of the solenoid shaft Figure 1 44 3 Remove the rear panel and the CPU Board as described in Section 1 3 1 2 4 Each solenoid has an electrical connection to the valve board which must be unpl...

Страница 34: ...r compartment is fully exposed 3 Partially slide the paper tray out 4 Tear the paper roll from the printer and completely remove the paper roll and the paper tray Do not pull the paper from the printer as this can damage the printer 5 To remove paper from the printer press the feed button 6 Slide fingers under the printer green board along the side to the back until an opening is detected 7 Holdin...

Страница 35: ...ding tracks and slide a printer onto the analyzer 3 Press the printer firmly into place to ensure proper connection to the CPU board 4 Verify the printer is working by running a printer test under the Diagnostic Menu Main Operations Menu Diagnostics Check Printer 5 Compare the print out to Figure 1 50 to verify correct function Figure 1 50 Pinter test Note Never attempt to dislodge paper from the ...

Страница 36: ...mage may occur Figure 1 51 RFID Board 1 3 1 13 Valve Board CN A4018 Valve board has multiple connections to devices on a single platform The Aspiration Assembly Solenoid Valves Peri Pump Motor all plug into the valve board The lamp that lights the measurement pathway is also located on this board To access the board 1 The Rear Panel and CPU with RFID boards described in Section 1 3 1 2 must be rem...

Страница 37: ...the measurement pathway when fluids flow Figure 1 53 Valve Board Top The Bottom side of the Valve Board seven connectors for the Aspiration Assembly Solenoid Valves and Pump Motor Figure 1 54 Valve Board Bottom Valve Board Peri Pump Motor Plug Washer Screw to secure Valve Board Solenoid Valve Plugs Aspiration Assembly Plug Valve Board Ribbon Cable and Connector Lamps ...

Страница 38: ...play board To remove the display board 1 Follow the steps for removing the Rear Panel in Section 1 3 1 2 2 Then follow all steps for removal of the CPU board 3 Unplug the sample sensor cable from the front Figure 1 55 Valve Board Front 4 Then remove three screws and each of the 50 degree spacers to remove the display board Figure 1 56 Valve Board Front Display Screen Sample Sensor Connector Displa...

Страница 39: ... Effective Date 12 20 18 Page 39 of 58 Figure 1 57 Valve Board Rear 1 3 1 15 Interface PC This unit is located on the Rear Panel See figure 4 42 Figure 1 58 Interface PC Display Cable Connector Data Module Connector Interface PC Module SD Card ...

Страница 40: ...act to the sample Once measurement is complete the peristaltic pump moves the fluid back to the Fluid Pack into the Waste Container 1 4 2 Standard B and C The process for STD B and STD C is identical to that of STD A with the exception of the operation of solenoid valves B and C These solenoid valves are operated in reverse order of STD A aspiration 1 4 3 Reference Solution The reference solution ...

Страница 41: ...1 Introduction ECO 9099 SOP05 5090F Rev 00 Effective Date 12 20 18 Page 41 of 58 1 4 5 Fluidic Flow Path Figure 1 59 Fluid Flow ...

Страница 42: ...rocedure outlined in Section 1 3 1 10 to remove the indicator cap and crimp pin from each solenoid valve This facilitates the removal of tubing from each solenoid 4 Pull the two pump tubes of the peristaltic pump tube set off the pump rotor 5 Unplug the reference from the connector Use a towel to absorb any reference solution that leaks from the housing 6 Pull out the white reference solution tube...

Страница 43: ...n left side 17 Install the reference tube and reference solution tube connector 18 Place tubing into Left Guide Track with shortest first Waste In to the longest Standard A 19 Place all Standard A B C Reference solution and Air tubings into their tracks followed by their respective crimp pin then the indicator cap 20 Snap peristaltic pump into place 21 Connect the red tagged tube to the bottom of ...

Страница 44: ...1 Introduction ECO 9099 SOP05 5090F Rev 00 Effective Date 12 20 18 Page 44 of 58 Figure 1 62 Pinch Valve Tubing Set Diagram R Reference A Standard A V Vent B Standard B C Standard C R V A B C ...

Страница 45: ...1 Introduction ECO 9099 SOP05 5090F Rev 00 Effective Date 12 20 18 Page 45 of 58 1 4 7 Fluidic Diagram Figure 1 63 Fluidic Diagram SmartLyte Plus FLUIDIC DIAGRAM ...

Страница 46: ...icate over the interconnected flat ribbon cables Figure below represents the top level electronic design of the SmartLyte Plus Figure 1 64 Architecture showing top level electronic design 1 5 2 CPU Board Figure 1 64 shows CPU block diagram CPU board is responsible for following peripherals features Pump Valve Printer RS232 LIS Lamp Temperature Sensor Sample Sensor Signal processing RFID Fluid pack...

Страница 47: ...1 Introduction ECO 9099 SOP05 5090F Rev 00 Effective Date 12 20 18 Page 47 of 58 Figure 1 65 CPU board block diagram ...

Страница 48: ...on right of the buzzer This processor is preloaded with customized software to control the peripherals valve pump printer RFID signal processing temperature sensor sample sensor and buzzer 1 5 5 EMF and Noise Shielding SMPS technology used to generate 24V DC supply from 110 220V AC supply CPU board has voltage regulator and switches to 14V 2 048 5 2 5 and 3 3V These linear regulators and switches ...

Страница 49: ...erature Sensor circuit This circuit creates a temperature depended voltage which is converted by software to degree C In SmartLyte Plus there is no manual adjustment needed 1 5 11 Analog Channel and A D Converter The analog inputs from the amplifiers are connected to IC U23 This IC converts analog signal to digital readings that is then used by software for instrument operation 1 5 12 CPU board Co...

Страница 50: ...is a graphics printer with 192 dots of a TP series 1 5 16 Shielding and Grounding Beside the shield for eliminating the internal noise from the power supply the entire SmartLyte Plus is equipped with a protective shield to prevent the influence of magnetic fields and other noise sources in the laboratory The internal protective shield creates a Faraday Cage that protects instrument measurements fr...

Страница 51: ...und in the Operator s Manual describing the correct method to perform routine analyzer maintenance 2 1 Daily Perform cleaning cycle at end of the day Perform conditioning cycle at end of the day Check printer paper supply 2 2 Weekly Maintenance Clean sample probe and fill port Clean exterior analyzer surfaces 2 3 Monthly Maintenance Clean reference electrode housing 2 4 Six Month Maintenance Repla...

Страница 52: ...ed in the Standard A tubing or the electrode chamber Ensure the sample sensor is securely plugged in Perform the sample sensor test to verify sensor is operating correctly Ensure that all O rings are in place Check solenoid V for proper sealing of the vent line Prime Standard A to verify fluid pack has Standard A and peri pump is functioning correctly Replace the peristaltic pump tube set to ensur...

Страница 53: ...be displayed This test is performed at the beginning of each calibration cycle Look for ref segments coming out Check for leaks around connectors tubing and electrode Ensure that the reference tubing is securely connected to the receptacle Check that reference electrode is firmly installed in the housing Check for the presence of o rings and for proper sealing of the electrodes Under DIAGNOSTICS C...

Страница 54: ...ent chamber by running a sample and examining flow when backlight is on Expired Fluid Pack Inserted Fluid Pack has passed expiry date Insert new pack Inspect electrodes Stable reading of Standard A could not be obtained within 6 aspirations for all electrodes Ensure that electrodes are properly plugged in and aligned correctly Check the locking mechanism on electrode tray to ensure properly engage...

Страница 55: ...ibration Run Check electrodes to diagnose if problem is stability of the readings SD or mV values within 100 to 100 Invalid Fluid Pack Fluid Pack is not authentic Ensure Fluid Pack is for SmartLyte Plus Go to PACK STATUS in Main Operations Menu and verify pack information Ensure pack is properly inserted Ensure RFID tag is detected Under DIAGNOSTICS press CHECK RFID Contact Customer Support Li Cal...

Страница 56: ... OPERATIONS MENU DIAGNOSTICS CHECK TEMPERATURE If temperature is not within 1 to 2 degrees of room temperature replace sample sensor If new sample sensor does not fix the error replace CPU Communication Error Bad connection between display CPU and interface PC Check the flex ribbon connectors between Display CPU and interface PC Restart the unit and ensure pump turns on at power cycle Contact supp...

Страница 57: ...try again Check valve connectors are securely connected to valve board Air in Sample Air was detected during sample aspiration Please load sample when prompted to Pre loading sample may cause this issue Check sample volume Check fluid is flowing and there are no clogs specially if whole blood samples were analyzed Check sample sensor under diagnostic menu Air in STD AB Air was detected during STD ...

Страница 58: ...INTER PAPER Replace as necessary AV BP5019D REFERENCE ELECTRODE HOUSING Replace as necessary AV BP5006D SAMPLE PROBE Replace as necessary 4 2 Analyzer Parts for Repair Replacement Part Description CN A4010 ASPIRATION ASSEMBLY CN A4060 PRINTER GRAPHIC ASSEMBLY CN 4022 BASE ISE ELECTRODE TRAY SmartLyte Plus CN A4405 BOARD CPU SmartLyte Plus CN A4406 BOARD DISPLAY SmartLyte Plus CN A4054 BOARD RFID C...

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