Sensa Core ST-200 aQua Operator's Manual

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OPERATOR’S MANUAL

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ST-200 aQua Operator’s Manual

ST-200 aQua

Na/K/iCa/Li/pH/Cl Electrolyte Analyzer

OPERATOR’S MANUAL

SENSA CORE MEDICAL INSTRUMENTATION PVT. LTD.

Plot No.3, Export Promotion Industrial Park,

Pashamylaram, Sangareddy (Dist), Hyderabad, Telangana, 502307.

www.sensacore.com, Tel: +08455 223400.

sales@sensacore.com

ST-200 aQua Operator’s Manual

Understanding the ST-200 aQua Electrolyte Analyzer

…...

Intended Use

…..

Summary and Explanation

…..

Operational Hazards and Precautions

…..

Analyzer Installation

…..

Unpacking

…..

Component Installation/Replacement

…..

Fluid control valve

…..

Reference housing

…..

Building the Electrodes stack

…..

Installation of tubing

…..

Reagent Pack Installation

…..

Analyzer Restoration

…..

Printer Setup

…..

Power Up

…..

Operating the Analyzer

…..

Calibration

…..

Analyze Sample

…..

Daily Cleaner

…..

Standby

…..

Sub Menus

…..

Analyze Urine

…..

Stored Results

…..

Reagent Pack Consumption

…..

Quality Control

…..

Operator Functions

…..

Diagnostics

…..

User menu

…..

Setup menu

…..

PREFACE

ST-200 aQua Operator’s Manual

Parameters

…..

Select iCa Unit

…..

Sample Handling and Collection

…..

Whole Blood

…..

Serum

…..

Plasma

…..

Urine

…..

Expected Values

…..

Maintenance

…..

696.Principles of Operation

…..

ISE Theory

…..

Specifications of Na/K/iCa/Li/pH/Cl

…..

728.Troubleshooting

…..

Introduction

…..

Flow path system

…..

Flow errors

…..

Electrode Assembly

…..

Reagent Pack

…..

Bubble Detector

…..

Printer

…..

Display Messages

…..

10.

Appendices

…..

Warranty

…..

ST-200 aQua Operator’s Manual

S/N

Figure

Figure no.

Page no.

ST-200 aQua

Fluid control valve

Reference electrode

Reference electrode removal

Building the Electrode Stack

Parameter combinations

Pump assembly modules

Pump tube installation

Reagent pack installation

10.

Vent holes on reagent pack caps

11.

Printer setup

12.

Back view connection

13.

Aspirating sample

14.

Aspirating daily Cleaner

15.

Pressing Standby button

16.

Aspirating urine

17.

Correction Factor-Slope

18.

Correction Factor-Intercept

19.

Flow path system

20.

Bubble detector

21.

Flow cell cover

FIGURES

ST-200 aQua Operator’s Manual

ST-200 AQUA ELECTROLYTE ANALYZER (6 Ch)

1. Understanding the ST-200 aQua Electrolyte Analyzer

A. Intended Use

The ST-200 aQua is an automated, microprocessor-controlled analyzer for measurement of sodium, potassium, ionized calcium, Lithium, Chloride & pH in serum, plasma, whole blood, diluted urine and cerebrospinal fluid.

To obtain accurate results, the ST-200 aQua must be operated with Our Company’s specially packaged calibrant and bovine-based control materials and be maintained as described in this manual.

B. Summary and Explanation

Designed for fast, efficient use, the ST-200 aQua provides clinically accurate analysis for patient diagnosis and treatment. The analysis takes 75 seconds and requires approximately 150 micro liters of serum, plasma, whole blood, CSF or 400 micro liters of diluted urine (65 seconds urine analysis cycle).

You will be guided through the display menu by pressing on keypad the “Y” or “N” button in response to questions and messages that appear on the display. Calibration is automatic, but can be performed on demand. A unique reagent pack contains Cal “A” & Cal “B” to calibrate the analyzer. The ST-200 aQua Electrolyte analyzer has a external waste container for analyzed samples and solutions, eliminating the need to handle biological waste materials.

Many medication states the cause of temporary imbalance of the body’s electrolyte, requires necessary treatment to the patient. Drugs for hypertension act as diuretics, causing the body to excrete high levels of potassium in the urine. Imbalances in the body’s potassium level affect the neurological and muscular activity of the body. Drugs that influence sodium concentration include all diuretics, chloropropamide, vasopressin, antihypertensive agents and corticosteroids. Sodium imbalance is often associated with dehydration and edema. Chloride values are seen in metabolic acidotic states and in salt losing renal diseases.

ST-200 aQua Operator’s Manual

C. Operational Hazards and Precautions

Read the operator’s manual before setting up or operating the ST-200 aQua electrolyte analyzer.

Observe all warnings, notes and key information in this manual.

Failure to leave the ST-200 aQua electrolyte analyzer to power with the REAGENT PACK in place could damage the electrodes and cause blockage.

There are no operator serviceable parts inside the ST-200 aQua electrolyte analyzer. If electromechanically problems are suspected, DO NOT attempt to open the back cover. Contact your authorized technical service representative.

The power cord of the ST-200 aQua electrolyte analyzer must be connected to a matching ground outlet supplying 110 VAC, 50/60 Hz 0r 230 VAC, 50/60 Hz, as indicated on the label on the rear panel of the analyzer.

The ST-200 aQua electrolyte analyzer contains sensitive electronics and must be properly grounded. The ST-200 aQua electrolyte analyzer should not be plugged into a circuit protected by a GFI (Ground Fault Interrupter).

The environment should be as free as possible from dust, mechanical vibrations, and electrical interference. Avoid proximity to brush-type motors (certain type of centrifuges), diathermy instruments, flickering fluorescent lights and arcing contacts of any kind. Do not install the ST200 aQua electrolyte analyzer near heat producing equipment or near incandescent lighting.

BIOHAZARD

When collecting and handling biological specimens, the center for Disease control (CDC) recommends that all samples be considered biohazards which may be contaminated with HIV or other pathogens. Any replaceable item which comes in contact with biological samples, including the sample probe, solution valve, probe wipers, sample tube, sample detector, electrodes, electrode connectors, membrane assembly, electrode housing, pump tubing and solutions pack may contain potentially contaminated material. Treat all components, during use and dispose, as you would use any biohazardous material.

ST-200 aQua:

ST-200 aQua Operator’s Manual

Figure 1

ST-200 aQua Operator’s Manual

a. Fluid Control Valve:

Valve holder

INSTALLATION

2. Analyzer Installation

A. Unpacking

Upon arrival, carefully remove the ST-200 aQua electrolyte analyzer and accessories from shipping containers and place on solid work surface. Visually inspect ST-200 aQua electrolyte analyzer for any damage sustained during shipment. If any damage is found, please inform to your nearest authorized dealer of ST-200 aQua electrolyte analyzer.

B. Component Installation/Replacement

To install or replace ST-200 aQua electrolyte analyzer components, follow the procedures in this chapter. New ST-200 aQua electrolyte analyzers are shipped with the fluid control valve and two pump motors.

Valve is mounted in ST-200 aQua for the supply of Calibrant A, Calibrant B solutions as per requirement. It controls the flow of Calibrant solutions by moving the lock pin.

Valve Side View Valve Top View

Figure 2

Pinch Valve handling:

For removing or replacement of Valve should be done by using proper

star screw driver if not screw driver will damage the valve holder.

While tightening pinch valve’s screws there should not apply extra pressure and it should not be super tight. Every time valve should be handled gently.

ST-200 aQua Operator’s Manual

b. Reference Housing:

Flow Cell

Reference Seal

Internal Filling Solution

Reference Membrane

Remove the reference electrode from its package. Wipe the outside of the reference electrode to dry. Make sure all surfaces are clean and dry. Reference housing consists of a KCl solution. It comes with black lock on the seal to avoid transportation leakage of KCl Solution. Remove the black

lock part from the seal of Reference housing mandatory before installation.

Figure 3

Reference Housing: Electrode Removal

Remove the SM lock from the top of the Bubble detector and Slide the electrode stack up at least one inch by gently pushing up on the last pin.

Figure 4

ST-200 aQua Operator’s Manual

c. Building the Electrode Stack:

Assemble the electrode by following the arrow marks and bubble detector by inserting seals in between every electrode and bubble detector. Make sure that the arrow mark on the electrodes should indicates upper side, each component should be clean and dry and also there should be a seal at the bottom of electrode. Stack the electrodes as shown in fig.

Figure 5

ST-200 aQua Electrolyte analyzer comes with two blocks of 3 in 1 electrodes. The block 1 comes with two types of parameter combinations i.e; K, Na & K, Na, iCa and the block 2 comes with 8 types of parameter combinations as per the requirement (refer Figure 6).

Electrode housing must be in place to ensure proper operation. Upon replacement of electrode blocks, use new electrode rubber seal. The seals must be clean and dry.

MODEL 1 -- K/ Na MODEL 2 -- K/ Na /Cl MODEL 3 -- K/ Na /iCa MODEL 4 -- K/ Na /iCa /Cl MODEL 5 -- K/ Na /iCa /Li MODEL 6 -- K/ Na /iCa /pH MODEL 7 -- K/ Na /iCa /Li/pH MODEL 8 -- K/ Na /iCa /pH/Cl MODEL 9 -- K/ Na /iCa /Li/Cl MODEL 10 -- K/ Na /iCa /Li /pH/Cl

Loading the Stack

d. Installation of tubing:

ST-200 aQua Operator’s Manual

Figure 6

Slide the electrode stack into the electrode housing. Push down firmly until the bubble detector snaps into position.

Carefully install the bubble detector and the electrode blocks into the electrode housing in such a manner that electrode blocks silver pins should be inserted in female connector.

Do not force the electrode housing into place. If the electrode blocks are properly installed, the electrode housing should slide easily into position.

The ST-200 aQua Electrolyte analyzers comes with two pump motors.

The first pump motor is used for the flow of CAL-A & CAL-B solutions in to the electrode housing in control with the valve. Its inflow is from the valve and outflow is to the bubble detector flow cell and electrode housing. Connect its outflow tube at the side of the flow cell pin.

The second pump motor is used for the flow of sample, QC, CAL-A & CALB fluids from electrode housing to the waste bottle. Its inflow is from electrode housing and outflow is to the waste bottle. Its pump tube has two stoppers. One stopper (red) is connected at the base of the electrode housing and the other stopper (blue) is connected to the waste bottle.

ST-200 aQua Operator’s Manual

Figure 7

ST-200 aQua Operator’s Manual

1. Module base: It is fixed to the chassis through a lock at the top of

2. Rollers: It consists of grove at its bottom and a knob on the front

3. Pump tubing: Insert the tubing as per the direction by holding the

4. Front cover: It is used to lock the rollers and pump tubing as

Figure 8

Pump tube installation procedure:

base as shown in the figure. We need to place the base bottom side first followed by the top, which consists of lock.

side. Grove side should be inserted to the base knob.

roller firmly after applying the grease around it as shown in the figure.

shown in the figure. Ensure that the tag of pump tubing should be above the front cover lock.

ST-200 aQua Operator’s Manual

e. Reagent Pack Installation:

Reagent packs consists CAL-A and CAL-B solutions in separate containers. Do not squeeze the reagent pack. Remove the caps and seals of the CAL-A and CAL-B containers. Hold the reagent pack in your hand and place reagent pack into back side slot of the analyzer; connect the CAL-A tube cap to the CAL-A container and CAL-B tube cap to the CAL-B container respectively as shown in below figures. Make sure that the caps should be fixed and tighten properly.

Do not use expired reagent pack. The electrode should be exposed to ST-200 aQua reagent all time so that it will protect electrode from getting damaged.

ST-200 aQua Operator’s Manual

Figure 9

Note: Don’t place the ST-200 aQua reagent packs open to atmosphere. Because,

the solutions gets escape from the containers. Only the small vent holes on the

caps should be open for air inlet as shown below figure.

Figure 10

ST-200 aQua Operator’s Manual

 Place the instrument into Maintenance mode.

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

DIAGNOSTICS

1. DAILY CLEANER

2. MAINTENANCE

3. SENSORS

4. FLOW

5. HARDWARE

6. REAGENT PACK

ENTERING MAINTENANCE

Please wait …

 To clean the flow path:

1. Enter in to maintenance mode and remove the electrode housing

2. Remove the reagent pack CAL-A & CAL-B flow tubes from the

3. Remove the first pump motor tubing from the roller. Take the DI

 To clean the electrode blocks:

***MAINTENANCE ***

N→ Exit

C. Analyzer Restoration:

To remove or replace any ST-200 aQua components, restore the ST-200 aQua in following order:

Press 1

↓

Press 2

Cleared liquid from the tubing

by disconnecting first pump outflow tube from the bubble detector flow cell pin and disconnect the second pump motor inflow (red) tube from the electrode housing.

caps and valve.

↓

water in to the bold needle syringe, connect it to the tubing and flush it with DI water and air.

If the Calibration slopes are out of range. Then, clean the electrodes by flushing with DI water/CAL A. Do not use any plain or spring needle to clean the electrode block.

ST-200 aQua Operator’s Manual

1. Use only the printer paper provided by your ST-200 aQua

2. Do not permit the printer to operate without printer paper

3. In this situation go to SETUP MENU, press default setting enter

4. Do not apply any lubricants, grease or other materials to the

D. Printer Setup:

The built-in printer will provide a permanent record of calibration and analysis results. Other data can also be requested for printing. If required, the printer can be turned off. (To prevent damage to the printer mechanism, the printer must be turned off if the ST-200 aQua electrolyte analyzer runs out of printer paper.)

Refer to the following precautions:

In order to open the printer door lift the left side lock upward direction. To install the roll of paper into the printer, cut off the beginning section of paper that has tape or adhesives. After installing the paper, close the cover on the top of the housing until the door gets locked.

Use of the ST-200 aQua electrolyte analyzer printer requires some precautions:

electrolyte analyzer distributor.

installed.

the PRINTER section and select the required option “Y” or “N” for Printer ON /OFF. The absence of paper during printer operation will cause premature printer failure.

printer assembly under any circumstances. Failure to comply with the above requirements will void the printer warranty.

Printer setup

Figure 11

ST-200 aQua Operator’s Manual

SENSACORE

ELECTROLYTE ANALYZER

Ver : XXXXXX

E. Power Up:

Confirm that the ST-200 aQua electrolyte analyzer voltage setting on the rear cover matches the outlet voltage. When all the components have been assembled, plug the ST-200 aQua electrolyte analyzer into a grounded outlet. When the ST-200 aQua electrolyte analyzer is plugged in, the power is ON. The Na/K/iCa/Li/pH/Cl analyzer will display,

When the ST-200 aQua electrolyte analyzer displays SYSTEM UNCALIBRATED PLEASE CALIBRATE, installation is complete. After initial setup, do not unplug the ST-200 aQua electrolyte analyzer unless it must be moved to another location.

Diagram of Back view connections:

Figure 12

ST-200 aQua Operator’s Manual

INITIALIZING…

ACQUIRING RANGES

Please Wait…

SENSACORE

System Uncalibrated

Please Calibrate….

Na* K* iCa* Li* pH* Cl*

CALIBRATE

Y→ Continue N→ Exit

PUMPING AIR

SELF CHECK

Searching pack

OPERATING THE ANALYZER

3. Operating the Analyzer

A. Calibration

The instrument has to be calibrated when it is switched ON or it automatically calibrates on set calibrated frequency after four hours or eight hours as per set frequency.

Following is the calibration procedure:

A. Calibration

Switch ON the instrument

↓

Press CALIBRATE key

↓

Press Y Displays PUMP CALIBRATION STEPS

↓

PUMPING CAL A

To clean the electrodes

CAL B MEASUREMENT

Na = ______ mV K = ______ mV iCa= ______ mV Li = ______ mV pH = ______ mV Cl = ______ mV

CAL A MEASUREMENT

Na = ______ mV K = ______ mV iCa= ______ mV Li = ______ mV pH = ______ mV Cl = ______ mV

ST-200 aQua Operator’s Manual

↓

PUMP CAL A TEST

Pump CAL = 1137

↓

PUMPING AIR

↓

… 3 cycles

Air, Liquid Air, Liquid

Air, Liquid

Displays CAL B milli volts on display E.g.: Na= 13.46 mV

Displays CAL A milli Volts on display E.g: Na = 33.27 mV

K = 30.64 mV iCa = 66.31 mV Li = 67.48 mV pH = -31.05 mV Cl = 66.45 mV

↓

…3 cycles Air, Liquid Air, Liquid Air, Liquid

K = 48.59 mV iCa = 54.76 mV Li = 50.77 mV pH = -61.24 mV Cl = 50.42 mV

ST-200 aQua Operator’s Manual

CALIBRATION SLOPE

Na = _______ K = _______ iCa = _______ Li = _______ pH = _______ Cl = _______

↓

Finally the instrument displays calibration slope and is ready for analysis.

E.g.: Calibration Slope

Na = 67.10 K = 61.77 iCa = 36.54 Li = 76.02 pH = 58.53 Cl = 51.54

If any parameter is not calibrated then it will show * beside that parameter in home screen. So that, we can clearly see the status of instrument.

B. Analyze Sample

To obtain patient’s sample, follow the procedure and precautions described under sample handling and collection. Quality control material should be run prior to patient sample analysis.

Aspirating sample

Figure 13

ST-200 aQua Operator’s Manual

ANALYZE SAMPLE

Y→ Continue N→ Exit

is Sample Ready?

Y→ Continue N→ Exit

Positioning Sample

SAMPLE MEASUREMENT

Na = ______ mV K = ______ mV iCa= ______ mV Li = ______ mV pH = ______ mV Cl = ______ mV

Processing…

Na = ______ mV K = ______ mV iCa= ______ mV Li = ______ mV pH = ______ mV Cl = ______ mV

Once system is calibrated then it is ready to analyze patient samples, press Analyze key

Press Y

↓

Take the sample by the pipette, drop it in the flow cell and Press Y

↓

Please wait …

↓

Sample is positioned into the sensors

Displays given SAMPLE milli Volts on display.

E.g. Na = 32.39 mV

K = 49.08 mV iCa = 53.72 mV Li = 56.63 mV pH = -78.90 mV Cl = 54.12 mV

↓

Displays CAL A milli Volts on display.

↓

ST-200 aQua Operator’s Manual

ANALYZE SAMPLE

Na = 140.9 mmol/L K = 4.02 mmol/L iCa = 1.25 mmol/L Li = 1.15 mmol/L pH = 7.516 Cl = 100.2 mmol/L

Na+

: 20.0 - 250.0 mmol/L

K+

: 0.2 - 40.0 mmol/L

iCa++

: 0 - 10.0 mmol/L

Cl-

: 20.0 - 200.0 mmol/L

: 0 - 5.0 mmol/L

pH : 5.0 - 9.0

Na+

: 20.0 - 250.0 mmol/L

K+

: 0.2 - 40.0 mmol/L

iCa++

: 0 - 10.0 mmol/L

Cl-

: 20.0 - 200.0 mmol/L

: 0 - 5.0 mmol/’L

: 5.0 - 9.0

Eg. Na = 33.76 mV

K = 49.54 mV iCa = 54.33 mV Li = 48.52 mV pH = -62.32 mV Cl = 49.73 mV

↓

Result Outside the measurement ranges as follows will not be reported WHOLE HAPERIN BLOOD

SERUM, PLASMA & CSF:

If iCa unit is in mg/dL, then the measurement range is 0-40 mg/dL.

C. Daily Cleaner

Execute Daily Cleaner Solution every day mandatory to remove protein deposition from the sensors. The daily cleaner is required and is essential for trouble-free analyzer operation. Following is the procedure of daily cleaner.

Giving daily cleaner

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

DIAGNOSTICS

1.DAILY CLEANER

2.MAINTENANCE

3.SENSORS

4.FLOW

5.HARDWARE

6.REAGENT PACK DAILY CLEANER

is Cleaner Ready?

Y→ Continue N→ Exit

ST-200 aQua Operator’s Manual

Press MENU

Press 1

Figure 14

↓

Take the Cleaning Solution by the pipette, drop it in the flow cell and Press Y

↓

ST-200 aQua Operator’s Manual

Aspirating

Please Wait …

CLEANING

Performing…

PUMPING AIR

PUMPING CAL A

PUMPING AIR

Clean Cycle Performed

PUMPING AIR

PUMPING CAL A

CAL B MEASUREMENT

Na = ______ mV

K = ______ mV iCa= ______ mV Li = _______ mV pH = ______ mV Cl = ______ mV

CAL A MEASUREMENT

Na = ______ mV

K = ______ mV iCa= ______ mV Li = ______ mV pH = ______ mV Cl = ______ mV

↓

Displays CAL B milli Volts

↓

…….3 cycles of Cal B

Air, Liquid Air, Liquid

Air, Liquid

↓

….......3 cycles of Cal A

Air, Liquid Air, Liquid Air, Liquid

↓

Displays CAL A milli Volts

PUMPING AIR

PUMPING CAL A…

PUMPING CAL A

CAL B MEASUREMENT

Na = ______ mV K = ______ mV iCa= ______ mV Li = ______ mV pH = ______ mV Cl = _______ mV

CAL A MEASUREMENT

Na = ______ mV K = ______ mV iCa= ______ mV Li = ______ mV pH = ______ mV Cl = ______ mV

Searching pack

To clean the electrodes

ST-200 aQua Operator’s Manual

↓

PUMP CAL A TEST

Pump CAL = 1460

↓

PUMPING AIR

↓

Displays CAL B milli volts on display

↓

… 3 cycles

Air, Liquid Air, Liquid

Air, Liquid

↓

…3 cycles Air, Liquid Air, Liquid Air, Liquid

Displays CAL A milli Volts on display

↓

ST-200 aQua Operator’s Manual

CALIBRATION SLOPE

Na = _______ K = _______ iCa = _______ Li = _______ pH = _______ Cl = _______

*** STANDBY ***

N→ Exit

EXITING

STANDBY MODE

Finally displays calibration slope & instrument is ready for analysis.

D. Standby

Placing the ST-200 aQua in STANDBY mode reduces reagents consumption by discontinuing automatic calibrations. The analyzer does, however, draw a small amount of calibrant A solution to prevent the electrodes from drying out which is called as “Sipping”. To place the ST200 aQua in standby mode, press STANDBY key.

After pressing STANDBY key

Press N

Pressing Standby Button:

↓

Figure 15

E. Sub Menus

i. Diagnostics

ST-200 aQua Operator’s Manual

ii. User Menu

ST-200 aQua Operator’s Manual

iii. Setup Menu

ST-200 aQua Operator’s Manual

iv. Parameters

ST-200 aQua Operator’s Manual

Note: Star (*) Indicates Blank

ST-200 aQua Operator’s Manual

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

ANALYZE TYPE

1.SERUM/PLASMA

2.URINE

3.WHOLE BLOOD

4.QUALITY CONTROL

5.NON DETECTABLE

ANALYZE TYPE

URINE

N→ Exit

SETUP MENU

1.ANALYZE TYPE

2.DATE/TIME

3.PRINTER

4.PRINT-PARAMETER

5.PRINT-mV

6.PATIENT-ID

F. Analyze Urine

To obtain urine sample, follow the procedure and precautions described under sample handling and collection.

Dilute 200 microlitres of urine specimen with 1 mL (1000 microlitres) of urine diluent’s (this corresponds to 1 part urine and 5 parts urine diluent’s resulting in 1:5 dilutions).

Note: In urine mode only Na, K, Cl parameters are measured but not all.

After dilution change Analyze type to URINE mode by following below steps

Press MENU

↓

Aspirating urine:

ANALYZE URINE

Y→ Continue N→ Exit

is Urine Ready?

Y→ Continue N→ Exit

Positioning Urine

URINE MEASUREMENT

Na = ______ mV K = ______ mV Cl = ______ mV

ST-200 aQua Operator’s Manual

Figure 16

Set instrument in Urine type as follows:

↓

Press Y

Take the diluted urine solution by the pipette, drop it in the flow cell and Press Y

↓

Please Wait …

↓

ST-200 aQua Operator’s Manual

Processing …

Na = ______ mV K = _____ mV Cl =______ mV

ANALYZE URINE

Na = 379.90 mmol/L K = 78.22 mmol/L Cl = 357.76 mmol/L

Na+

35 - 1000 mmol/L

K+

50 - 200 mmol/L

Cl-

25 - 500 mmol/L

1. Sample Results

2. QC Results

3. Urine Results

milli Volts of urine sample will be display. e.g. Na = 10.15 mV

K = 76.56 mV

Cl = 64.26 mV

↓

milli Volts of CAL A will be displayed on the display.

e.g. Na = 33.68 mV

K = 49.47 mV

Cl = 49.80 mV

↓

Result Outside the measurement ranges as follows will not be reported

URINE RANGE

G. Stored Results

Press MENU 2. USER MENU 4. PRINT STORED RESULTS

The ST-200 aQua has data storage and recovery capability of 2 Lakhs+ patients results, 25000 Urine results and 100 QC results. All results from the oldest day will be deleted when the storage capacity has been reached. Therefore it is important to request a printout of data as the storage capacity is approached if you desire to retain a copy of all the stored results.

ST-200 aQua Operator’s Manual

STORED SAMPLE RESULTS

Please Enter ‘5’ Dig

Patient ID :

XXXXX

Y→ Continue N→ Clear

STORED SAMPLE RESULTS

Searching ...

P.ID: XXXXX Na = _______ K = _______ iCa = ______ Cl = ______ Li = _______ pH = _______

Y → Print N → Exit

SEARCHING PATIENT ID:

ST-200 aQua is having a feature to search patient results by entering Patient ID. User should enter patient ID (up to 5 numeric digits), after Pressing Y it will display results on screen, user can take print out by pressing Y button again.

Press Y

↓

Press ‘Y’ to print displayed result or press ‘N’ to exit.

H. Reagent Pack Consumption

The ST-200 aQua monitors fluid consumption automatically. The percentage of the reagent pack that has been consumed can be checked whenever required by answering ‘Y’ to REAGENT PACK CONSUMPTION, the percentage of the reagent pack that has been left is displayed and printed. ST-200 aQua will instruct the operator to change pack by displaying message as INSUFFICIENT PACK PLEASE REPLACE, when 90% of the reagent pack solution has been consumed. Please make a note that due to variations in pump tubes elasticity analyzer gives ‘Air in CAL-A’ or ‘Air in CAL-B’ if Reagent pack shows solution left as 10-15 %.

Reagent Pack Installation

ST-200 aQua Operator’s Manual

a) Diagnostics

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

respectively as shown in below figures. Make sure that the caps should be fixed and tighten properly.

Do not use expired reagent pack. The electrode should be exposed to ST-200 aQua reagent all time so that it will protect electrode from getting damage.

Incompatible pack

If unauthorized reagent pack is trying to use in analyzer then it will display Incompatible pack on screen. Use authorized reagent pack.

I. Quality control

Use ST-200 aQua Quality controls on a daily basis to verify the accuracy and precision of your analyzer. If the ST-200 aQua is calibrated and your quality control results are within specified range, you can be confident in the results obtained.

Run all the control levels daily. Data may be stored in memory for future statistical analysis.

To perform quality control sample, set up ANALYZE TYPE as QC in set up menu. Refer to the Quality control ranges in performance certificate provided with the quality control solutions. Do not use control materials containing ethylene glycol and other stabilizer, as they may give incorrect results and/or damage the ST-200 aQua electrode blocks.

J. Operator Functions

Following are the steps to operate ST-200 aQua in the form of flow diagram.

1. DAILY CLEANER:

The diagnostics routine permits the operator to check and test key operating functions of the ST-200 aQua.

Following is the flow chart of diagnostics menu.

Press MENU

Press 1

ST-200 aQua Operator’s Manual

DIAGNOSTICS

1.DAILY CLEANER

2.MAINTENANCE

3.SENSORS

4.FLOW

5.HARDWARE

6.REAGENT PACK DAILY CLEANER

is Cleaner Ready?

Y→ Continue N→ Exit

Aspirating

Please Wait …

CLEANING

Performing…

PUMPING AIR

PUMPING CAL A

PUMPING AIR

Clean Cycle Performed

PUMPING AIR

PUMPING CAL A

CAL B MEASUREMENT

Na = ______ mV

K = ______ mV iCa= ______ mV Li = _______ mV pH = ______ mV Cl = ______ mV

↓

Press 1

↓

Take the Cleaning Solution by the pipette and drop it in the flow cell and Press Y

↓

…….3 cycles of Cal B

Air, Liquid Air, Liquid

Air, Liquid

↓

Displays CAL B milli Volts

CAL A MEASUREMENT

Na = ______ mV

K = ______ mV iCa= ______ mV Li = ______ mV pH = ______ mV Cl = ______ mV

Displays CAL A milli Volts

PUMPING AIR

PUMPING CAL A…

PUMPING CAL A

CAL B MEASUREMENT

Na = ______ mV K = ______ mV iCa= ______ mV Li = ______ mV pH = ______ mV Cl = _______ mV

CAL A MEASUREMENT

Searching pack

ST-200 aQua Operator’s Manual

↓

….......3 cycles of Cal A

Air, Liquid Air, Liquid Air, Liquid

↓

To clean the electrodes

↓

PUMP CAL A TEST

Pump CAL = 1460

↓

PUMPING AIR

↓

… 3 cycles

Air, Liquid Air, Liquid

Air, Liquid

Displays CAL B milli volts on display

↓

…3 cycles Air, Liquid Air, Liquid Air, Liquid

ST-200 aQua Operator’s Manual

Na = ______ mV K = ______ mV iCa= ______ mV Li = ______ mV pH = ______ mV Cl = ______ mV

CALIBRATION SLOPE

Na = _______ K = _______ iCa = _______ Li = _______ pH = _______ Cl = _______

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

DIAGNOSTICS

1.DAILY CLEANER

2.MAINTENANCE

3.SENSORS

4.FLOW

5.HARDWARE

6.REAGENT PACK

ENTERING MAINTENANCE

Please wait …

Displays CAL A milli Volts on display

↓

Finally displays calibration slope & instrument is ready for analysis.

2. MAINTENANCE:

Whenever operator wants to switch off the instrument then operator

should activate maintenance mode then he can switch off the instrument.

Press MENU

Press 1

↓

Press 2

Cleared liquid from the tubing

↓

Press N it will display

EXITING MAINTENANCE

Please wait …

SENSACORE

System Uncalibrated

Please Calibrate

Na* K* iCa* Li* pH* Cl*

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

DIAGNOSTICS

1.DAILY CLEANER

2.MAINTENANCE

3.SENSORS

4.FLOW

5.HARDWARE

6.REAGENT PACK

SENSORS

1.SENSOR CAL A-mV

2.SENSOR CAL B-mV N→ Exit

CAL A MEASUREMENT

***MAINTENANCE ***

N→ Exit

Press Calibrate Key.

ST-200 aQua Operator’s Manual

↓

3. SENSORS:

Sensors is used to check mV of the electrodes for each reagent separately

Press MENU

Press 1

Press 3

↓

Press1

↓

SENSOR CAL A-mV

↓

SENSOR CAL A-mV

Na = ______ mV K = ______ mV iCa = ______ mV Li = ______ mV pH = ______ mV Cl = ______ mV

Displays milli Volts of CAL A

SENSORS

1. SENSOR CALA-mV

2. SENSOR CAL B-mV

CAL B MEASUREMENT

SENSOR CAL B-mV

Na = ______ mV K = ______ mV iCa = ______ mV Li = ______ mV pH = ______ mV Cl = ______ mV

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

Press N

Press 2

ST-200 aQua Operator’s Manual

… 3 cycles of Cal A

Air, Liquid

Air, Liquid Air, Liquid

↓

SENSOR CAL B-mV

↓

…. 3 cycles of Cal B

Air, Liquid

Air, Liquid Air, Liquid

↓

Displays milli Volts of CAL B on display.

4. FLOW:

It is used when, inserting new reagent pack or troubleshooting flow issues in instrument by priming CAL A, CAL B & ALL.

Press 1

↓

DIAGNOSTICS

1.DAILY CLEANER

2.MAINTENANCE

3.SENSORS

4.FLOW

5.HARDWARE

6.REAGENT PACK

Press 4

FLOW

1.REAGENT PRIMING

2.PUMP CALIBRATION

3.VALVE TEST

N→ Exit

REAGENT PRIMING

1.PRIME CAL A

2.PRIME CAL B

3.PRIME ALL

N→ Exit

PRIMING CAL A

Please wait …

PRIMING CAL A

Priming Completed

N→ Exit

REAGENT PRIMING

1.PRIME CAL A

2.PRIME CAL B

3.PRIME ALL

N→ Exit

PRIMING CAL B

Please wait …

Reagent Priming

Press 1

ST-200 aQua Operator’s Manual

↓

Press 1

↓

Air is aspirated followed by CAL A through electrode housing.

↓

Press 2

Air is aspirated followed by CAL B through electrode housing.

↓

PRIMING CAL B

Priming Completed

N→ Exit

Press N

PRIMING CAL B

Priming …

REAGENT PRIMING

1.PRIME CAL A

2.PRIME CAL B

3.PRIME ALL

N→ Exit

PRIMING CAL B

Please wait …

PRIMING CAL A

Please wait….

PRIMING CAL A

Priming Completed

N→ Exit

REAGENT PRIMING

1.PRIME CAL A

2.PRIME CAL B

3.PRIME ALL

N→ Exit

FLOW

1.REAGENT PRIMING

2.PUMP CALIBRATION

3.VALVE TEST

N→ Exit

PUMPING AIR

Press 3

ST-200 aQua Operator’s Manual

↓

Air is aspirated followed by CAL B through electrode housing.

↓

Press N

↓

Air is aspirated followed by CAL A through electrode housing.

↓

Pump Calibration

Press 2

↓

ST-200 aQua Operator’s Manual

PUMPING CAL A

PUMP CAL A TEST

Pump CAL = 1545

N→ Exit

FLOW

1.REAGENT PRIMING

2.PUMP CALIBRATION

3.VALVE TEST

N→ Exit

VALVE TEST

1.CAL A FLOW

2.CAL B FLOW

3.CAL A/B In Flow

4.AIR FLOW

N→ Exit

CAL A FLOW ON

N→ STOP

CAL A FLOW OFF

N→ Exit

VALVE TEST

1.CAL A FLOW

2.CAL B FLOW

3.CAL A/B In Flow

4.AIR FLOW

N→ Exit

↓

Instrument performs pump calibration using Cal A & displays the pump steps.

VALVE TEST:

VALVE TEST is used to clean the flow path of valve, by using DI water & syringe

Press 3

↓

Press 1

Clean the CAL A flow path of valve before counter reaches ‘0’.

↓

Press N

↓

ST-200 aQua Operator’s Manual

CAL B FLOW ON

N→ STOP

CAL B FLOW OFF

N→ Exit

VALVE TEST

1.CAL A FLOW

2.CAL B FLOW

3.CAL A/B In Flow

4.AIR FLOW

N→ Exit

CAL A/B In Flow ON

N→ STOP

CAL A/B In Flow OFF

N→ Exit

VALVE TEST

1.CAL A FLOW

2.CAL B FLOW

3.CAL A/B In Flow

4.AIR FLOW

N→ Exit

AIR FLOW ON

N→ STOP

↓

Press 2

Clean the CAL B flow path of valve before counter reaches ‘0’.

↓

Press N

↓

Press 3

Clean the CAL A/B flow path (inlet) of valve and the tubing of first pump motor before counter reaches ‘0’.

Press N

↓

Press 4

Clean the flow cell which is present on the top of the bubble detector before counter reaches ‘0’.

↓

Press N

AIR FLOW OFF

N→ Exit

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

DIAGNOSTICS

1.DAILY CLEANER

2.MAINTENANCE

3.SENSORS

4.FLOW

5.HARDWARE

6.REAGENT PACK

HARDWARE

1.SAMPLE DETECTOR

2.PUMP MODULE

3.SOFTWARE VERSION

N→ Exit

SAMPLE DETECTOR TEST

PUMPING AIR

SAMPLE DETECTOR TEST

Air Detected

PUMPING LIQUID

Liquid Detected

N→ Exit

5. HARDWARE:

Press 1

ST-200 aQua Operator’s Manual

↓

Press 5

Sample detector

Press 1

↓

Liquid flows through bubble detector

↓

ST-200 aQua Operator’s Manual

HARDWARE

1.SAMPLE DETECTOR

2.PUMP MODULE

3.SOFTWARE VERSION

N→ Exit

PUMP SPEED → FAST

PUMP SPEED → SLOW

N→ Exit

HARDWARE

1.SAMPLE DETECTOR

2.PUMP MODULE

3.SOFTWARE VERSION

N→ Exit

SOFTWARE VERSION:

XXXXX

Date : DD-MM-YYYY

N→ Exit

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

Pump module functionality:

Press 2

Both Pump rotates and checks its statuses.

↓

Software version:

Press 3

↓

It shows the version & date

6. REAGENT PACK:

It shows the information of reagent pack like consumption, reagent pack lot no. or pack volume & information about CAL A, CAL B concentrations.

Press 1

↓

DIAGNOSTICS

1.DAILY CLEANER

2.MAINTENANCE

3.SENSORS

4.FLOW

5.HARDWARE

6.REAGENT PACK

Press 6

REAGENT PACK

1.REAGENT PACK ID

2.REAGENT PACK INFO

3.REAGENT PACK

CONSUMPTION

REAGENT PACK ID

:BE91132C000007E0 OEM/NON OEM:NON OEM DISTRIBUTOR ID: XX1 LOT NO: XXXXX PACK VOLUME: 450 mL

N→ Exit

REAGENT PACK

1.REAGENT PACK ID

2.REAGENT PACK INFO

3.REAGENT PACK

CONSUMPTION

REAGENT PACK INFO

MANUFACTURED ON: ****** EXPIRY DATE: ******

Y→ Continue

Press 1

ST-200 aQua Operator’s Manual

↓

REAGENT PACK ID

Please Wait…

↓

Press N

Press 2

↓

REAGENT PACK INFO

Please Wait …

↓

Reagent pack manufacturing and expiry date is displayed.

Press Y

↓

ST-200 aQua Operator’s Manual

CAL A CONCENTRATION

Na : 148.0

K : 4.10 iCa : 1.40 Cl : 127.00 Li : 0.30 pH : 7.400

CAL B CONCENTRATION

Na : 75.00 K : 2.10 iCa : 2.90 Cl : 60.00 Li : 2.00 pH : 6.78

N→ Exit

REAGENT PACK

1.REAGENT PACK ID

2.REAGENT PACK INFO

3.REAGENT PACK

CONSUMPTION

REAGENT PACK CONSUMPTION

Please Wait…

REAGENT PACK CONSUMPTION

Solution left : 98%

N→ Exit

NO OF SAMPLES : 10 TOTAL SAMPLES : 253

N→ Exit

Concentration of CAL A is displayed. Press Y

Concentration of CAL B is displayed. Press N

↓

Press 3

↓

Consumption of reagent pack is displayed in %. Press N

↓

No. of samples means total samples performed with the particular reagent pack since from pack installation. Total samples means total samples performed in the analyzer since from installation.

ST-200 aQua Operator’s Manual

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

USER MENU

1.NORMAL RANGES

2.CALIBRATION FREQUENCY

3.SIPPING FREQUENCY

4.PRINT STORED RESULTS

5.AUTO-STANDBY

6.CORRECTION FACTOR

RESETTING RANGES

Please wait…..

AQUIRING RANGES

Please wait….

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

NORMAL RANGES

1.RESET RANGES

2.USER SETTINGS

b) USER MENU

Users menu permits the operator to check and test key operating functions of the ST-200 aQua. Following is the flow chart of users menu.

Press 2

↓

Press 1

↓

Please make a note that if you press the RESET RANGES then instrument reset all the ranges to Default factory settings.

Press 1

↓

RANGES RESETTED

↓

NORMAL RANGES: USER SETTINGS

Press 2

↓

USER MENU

1.NORMAL RANGES

2.CALIBRATION FREQUENCY

3.SIPPING FREQUENCY

4.PRINT STORED RESULTS

5.AUTO-STANDBY

6.CORRECTION FACTOR

Press 1

USER SETTINGS

1.SAMPLE RANGES

2.URINE RANGES

3.QC1 RANGES

4.QC2 RANGES

5.QC3 RANGES

SAMPLE RANGES

1.Na

2.K

3.iCa

4.Cl

5.Li

6.pH N→ Exit

SAMPLE RANGES

Na MAX : 150.00

Na MIN : 135.00

Y→ Edit N→ Exit

-------EDIT-------

Na MAX : 150.00

Na MIN : 135.00

1→ Mx 2→ Mn N→ Exit

Na MAX :

Y→ Save N→ Clear

NORMAL RANGES

1.RESET RANGES

2.USER SETTINGS

Press 2

ST-200 aQua Operator’s Manual

↓

Press 1

↓

Press required parameter to be changed and enter its maximum and minimum ranges.

Example: Press 1

Press Y

↓

Press 1

Enter the value and press ‘ Y ‘ to Save and ‘ N ‘ to Clear. Similarly, for all the parameters in Sample, Urine & QC Ranges.

↓

ST-200 aQua Operator’s Manual

USER MENU

1.NORMAL RANGES

2.CALIBRATION FREQUENCY

3.SIPPING FREQUENCY

4.PRINT STORED RESULTS

5.AUTO-STANDBY

6.CORRECTION FACTOR

CALIBRATION FREQUENCY

STATUS : 4 HOURS

Y→ 4 HOURS N→ 8 HOURS

SIPPING FREQUENCY

STATUS : 30 MINS

Y→ 30 MINS N→ 1 HOUR

USER MENU

1.NORMAL RANGES

2.CALIBRATION FREQUENCY

3.SIPPING FREQUENCY

4.PRINT STORED RESULTS

5.AUTO STANDBY

6.CORRECTION FACTOR

CALIBRATION FREQUENCY

Instrument will perform automatic calibration for every 4 hours /8 hours for good

performance of the instrument.

Press 2

↓

Press Y to select 4 hours or N to select 8 hours calibration frequency.

SIPPING FREQUENCY

For every 30min /1 hour instrument takes 400ul of liquid to make electrodes wet

this is called sipping. Here we can select the sipping time frequency.

Press 3

↓

ST-200 aQua Operator’s Manual

USER MENU

1.NORMAL RANGES

2.CALIBRATION FREQUENCY

3.SIPPING FREQUENCY

4.PRINT STORED RESULTS

5.AUTO STANDBY

6.CORRECTION FACTOR

PRINT STORED RESULTS

1.Sample Results

2.QC Results

3.Urine Results

STORED SAMPLE RESULTS

Please Enter ‘5’ Dig

Patient ID:

XXXXX

Y→ Continue N→ Clear

P.ID :XXXXX

Na= 135.89 K = 4.215 iCa= 1.083 Cl = 92.559 Li= 0.00 pH= 7.06

Y→ Print N→ Exit

PRINT RESULTS

Press 4

PRINT STORED SAMPLE RESULTS:

Press 1

↓

Enter Patient ID maximum up to 5 numeric digits which you want to search Press Y

↓

STORED SAMPLE RESULTS

Searching …

↓

Press “Y” to print displayed result or press “N” to shift to next result screen.

PRINT STORED QC RESULTS:

CONTROL in settings menu.

For storing QC results separately user must select ANALYZE TYPE to QULATIY

ST-200 aQua Operator’s Manual

PRINT STORED RESULTS

1.Sample Results

2.QC Results

3.Urine Results

-- QC Samples --

1. Last 1-25 samples

2. Last 26-50 samples

3. Last 51-75 samples

4. Last 76-100 samples

N→ Exit

RESULT : 00

Y→ Next N→ Exit

RESULT : 01

Na= 135.89 K = 4.215 iCa= 1.083 Cl = 92.559 Li= 0.00 pH= 7.06

Y→ Print N→ Exit

RESULT : 01

Na= 135.89 K = 4.215 iCa= 1.083 Cl = 92.559 Li= 0.00 pH= 7.06

Y→ Next N→ Exit

Press 2

↓

Depending upon the result required select the range option.

Press 1

↓

Press Y

Press ‘ Y ‘ to print displayed result or press ‘ N ‘ to shift to next result screen. Press N

Press ‘ Y ‘ to display next result or press ‘ N ‘ to Exit.

Press ‘ Y ‘

↓

ST-200 aQua Operator’s Manual

RESULT : 02

Na= 133.54 K = 4.129 iCa= 1.083 Cl = 94.645 Li= 0.00 pH= 7.09

Y→ Print N→ Next

PRINT STORED RESULTS

1.Sample Results

2.QC Results

3.Urine Results

STORED URINE RESULTS

Please Enter ‘5’ Dig

Patient ID:

XXXXX

Y→ Continue N→ Clear

STORED SAMPLE RESULTS

Searching…

P.ID :XXXXX

Na= 382.28 K = 70.99 Cl= 374.82

Y→ Print N→ Exit

Press ‘ Y ‘ to print displayed result or press ‘ N ‘ to obtain next result.

PRINT STORED URINE RESULTS:

Press 3

↓

Enter Patient Id maximum up to 5 numeric digits which you want to search Press Y

Press ‘ Y ‘ to print displayed result or press ‘ N ‘ to shift to next result screen.

AUTO STANDBY

which depends on calibration frequency. If calibration frequency is 4 hrs, calibration occurs after 4 hrs from the previous calibration after that analyzer automatically goes into STANDBY mode.

↓

AUTO STANDBY option is used to ON the STANDBY mode automatically,

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

Press 2

USER MENU

1.NORMAL RANGES

2.CALIBRATION FREQUENCY

3.SIPPING FREQUENCY

4.PRINT STORED RESULTS

5.AUTO-STANDBY

6.CORRECTION FACTOR

AUTO-STANDBY

STATUS : ON

Y→ON N→OFF

USER MENU

1.NORMAL RANGES

2.CALIBRATION FREQUENCY

3.SIPPING FREQUENCY

4.PRINT STORED RESULTS

5.AUTO-STANDBY

6.CORRECTION FACTOR

SLOPE/INTERCEPT

1. Na

2. K

3. Cl

4. iCa

5. Li

6. pH

SLOPE/INTERCEPT

SLOPE FACTOR:

[ 01.00 ]

INTERCEPT:

+[ 00.00 ]

Y→ SET N→ Next

Press 5 for Auto-Standby

ST-200 aQua Operator’s Manual

↓

Press Y to On and N to Off

CORRECTION FACTOR

Press 6

Press 1

↓

Note: - By default Slope factor value is 01.00 & Intercept is 00.00.

ST-200 aQua Operator’s Manual

SLOPE FACTOR:

Slope factor is used for multiplying the factor with the result obtained.

Figure 17

In the above graph, green line indicates the normal/reference state (All the control levels lie with its range as per the Q.C sheet provided in the Q.C box) and red line indicates the error/out-off state (Electrodes are reading either higher or lower).

After running all the three controls only, we can confirm that whether slope factor/intercept should be added depending upon its readings.

In the above graph level-1, level-2 and level-3 of any parameter is reading on higher side. In this case we have to add slope factor between 0.5 to 1. So, that level-1, level 2 and level 3 results will be multiplied by that factor. E.g.: In the above graph, when all the three Q.C levels are analyzed. We have got Na on higher side. In this case, we have to insert slope factor of 0.92. Now, 0.92 will be multiplied with the result of Na (e.g.: 130*0.92=119).

After adding slope factor we should run all the three controls and verify whether selected parameter (parameter which needed correction) lie within its range. Slope factor should be added and verified until the parameter lie in its range.

If level-1, level-2 and level-3 of Na is reading on lower side (i.e. reverse of above case). Then, we have to add slope factor between 1to 1.5. So, that level-1, level 2 and level 3 results will be multiplied by that factor.

Y = m X + C

Where, m = slope. If we add slope factor from 0.5 to 1, then our output(Y) will be decreased. Since, slope factor will be multiplied with X (obtained result). Similarly, if we add slope factor from 1 to 1.5, then our output will be increased. Since, slope factor will be multiplied with X (obtained result).

Note: Slope factor ranges from 0.5 to 1.5 for Na, K, iCa, pH, Li, Cl parameters individually.

ST-200 aQua Operator’s Manual

SLOPE/INTERCEPT

SLOPE FACTOR:

[ 01.00 ]

INTERCEPT:

+ [ 00.00 ]

Y→ ‘+’ N→ ‘- ‘

INTERCEPT:

Intercept is used if all the three control values read either higher or lower.

Figure 18

(i.e.) y = mx + c

Where m is the slope of the line and C is the y-intercept, which is the y-coordinate of

the location where line crosses the y axis.

For increasing/decreasing all the control values to desired level we have to select + or -10 variation for Na, Cl & + or – 0.5 variation in K, pH, iCa, Li. In the above graph of intercept, Na is reading all the three control levels higher approximately by 10. In this case we have to subtract intercept as 10.00 and verify it by running all three controls. Similarly, for all the parameters intercept can be added according to their requirement and respectively intercept ranges.

Note: - By default Slope factor value is 01.00 & Intercept is 00.00

Select + or – 10 variation for Na, Cl & + or – 0.5 variation in K, pH, iCa, Li according to the necessity for result.

Press N

ST-200 aQua Operator’s Manual

SLOPE/INTERCEPT

1. Na

2. K

3. Cl

4. iCa

5. Li

6. pH

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

SETUP MENU

1.ANALYZE TYPE

2.DATE/TIME

3.PRINTER

4.PRINT-PARAMETER

5.PRINT-mV

6.PATIENT-ID

ANALYZE TYPE

1.SERUM/PLASMA

2.URINE

3.WHOLE BLOOD

4.QUALITY CONTROL

5.NON DETECTABLE

ANALYZE TYPE

SERUM/PLASMA

N→ Exit

ANALYZE TYPE

1.SERUM/PLASMA

2.URINE

3.WHOLE BLOOD

4.QUALITY CONTROL

5.NON DETECTABLE

C) Setup Menu

Setup menu permits the operator to check and test key operating functions of the ST-200 aQua.

Following is the flow chart of setup menu.

Press 3

Press 1

↓

Press N

Press 2

↓

ANALYZE TYPE

URINE

N→ Exit

Press N

ANALYZE TYPE

1.SERUM / PLASMA

2.URINE

3.WHOLE BLOOD

4.QUALITY CONTROL

5.NON DETECTABLE

ANALYZE TYPE

WHOLE BLOOD

N→ Exit

ANALYZE TYPE

1.SERUM / PLASMA

2.URINE

3.WHOLE BLOOD

4.QUALITY CONTROL

5.NON DETECTABLE

ANALYZE TYPE

QUALITY CONTROL

N→ Exit

ANALYZE TYPE

1.SERUM / PLASMA

2.URINE

3.WHOLE BLOOD

4.QUALITY CONTROL

5.NON DETECTABLE

ANALYZE TYPE

NON DETECTABLE

N→ Exit

Press 3

Press N

ST-200 aQua Operator’s Manual

↓

Press 4

Press N

Press 5

Non Detectable

↓

sometimes bubble detector will not detect sample gives air in sample, and then change the mode to NON DETECTABLE & run sample. Please make a note that after completion of sample analyze setup analyze to SERUM mode.

If there is any sample which consists of high Bilirubin (Lipemic samples)

ST-200 aQua Operator’s Manual

SETUP MENU

1.ANALYZE TYPE

2.DATE/TIME

3.PRINTER

4.PRINT -PARAMETERS

5.PRINT-mV

6.PATIENT-ID

DATE/TIME

DATE : MM DD, YYYY

TIME : HH:MM:SS

Y→ SET N→ NEXT

Select month

June

Y→ SET N→ NEXT

Select date

Y→ SET

Select Year

Y→ SET

DATE/TIME

DATE : June 23, 2017

TIME : ---:---:---

Y→ SET N→ NEXT

Date / Time:

By using this option user can change the Date & Time of the instrument. By using Y button we can select the field which we want to change & by using N button we can change the field.

Press 2

↓

Press Y

Set the Time: Hours

Select Hour:

Y→ SET

DATE/TIME

DATE : June 23, 2017

TIME : 11:---:---

Y→ SET N→ NEXT

Set the Time: Minutes

DATE/TIME

DATE : June 23, 2017

TIME : 11:47:---

Y→ SET N→ NEXT

DATE/TIME

DATE : June 23, 2017

TIME : 11:47:30

Y→SET N→NEXT

SETUP MENU

1.ANALYZE TYPE

2.DATE/TIME

3.PRINTER

4.PRINT-PARAMETERS

5.PRINT-mV

6.PATIENT-ID

ST-200 aQua Operator’s Manual

Select Minute:

Y→ SET

Set the Time: Seconds

Press N

The date and time has been set.

PRINTER:

User can switch OFF the printer if not required.

Select Seconds:

Y→ SET

↓

ST-200 aQua Operator’s Manual

PRINTER

STATUS : ON

Y→ON N→OFF

SETUP MENU

1.ANALYZE TYPE

2.DATE/TIME

3.PRINTER

4.PRINT-PARAMETERS

5.PRINT-mV

6.PATIENT-ID

PRINT PARAMETERS

1.Na

2.K

3.Cl

4.iCa

5.Li Y→ Next N→ Exit

SETUP MENU

1.ANALYZE TYPE

2.DATE/TIME

3.PRINTER

4.PRINT-PARAMETERS

5.PRINT-mV

6.PATIENT-ID

PRINT – mV

STATUS : ON

Y→ON N→OFF

Press 3

Press Y to ON, press N to OFF the printer status

Press 4

↓

If your required parameter is present in this screen then select the parameter by pressing appropriate number, if not then press Y button to see more parameters.

↓

PRINT PARAMETERS

6.pH

7.All N→ Exit

Press corresponding number for parameters details which to be analyzed and printed And press N to exit.

Print –mV:

If user don’t want to print mill volts (mV) of CAL A, CAL B but only wants results

then Print –mV can be deselected.

Press 5

↓

Press Y to ON, press N to OFF the PRINT – mV status

ST-200 aQua Operator’s Manual

SETUP MENU

1.ANALYZE TYPE

2.DATE/TIME

3.PRINTER

4.PRINT-PARAMETERS

5.PRINT-mV

6.PATIENT-ID

PATIENT-ID

- - - - - - - - - - -

STATUS : OFF

- - - - - - - - - -

1→ MANUAL 2→ AUTO

N→ OFF

 We can set manual & auto status for PATIENT ID (i.e.) press 2 for AUTO status, it

 In MANUAL status (i.e.) we have to provide PATIENT ID for each sample as per

Press Menu

1. K Na * * * *

2. K Na * * * Cl

3. K Na iCa * * *

4. K Na iCa * * Cl

5. K Na iCa Li * *

6. K Na iCa pH * *

Y → Next N→ Exit

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

PATIENT ID:

Patient ID should be ON to get previous stored results. If patient –ID option is

deselected then instrument will not ask to enter patient ID while analyzing.

Press 6

↓

takes the PATIENT ID spontaneously in serial wise for each sample without giving PATIENT ID.

requirement.

D) Parameters:

Depending upon requirement change model of the analyzer ensure that Electrode blocks stacking should be done according to the order in parameter option.

Where * indicates blank electrode.

Press 4

↓

ST-200 aQua Operator’s Manual

1. K Na iCa Li pH *

2. K Na iCa pH * Cl

3. K Na iCa Li * Cl

4. K Na iCa Li pH Cl

N→ Exit

 By selecting the parameters as per requirement & arrange the

1.DIAGNOSTICS

2.USER MENU

3.SETUP MENU

4.PARAMETERS

5.SELECT iCa UNIT

iCa UNITS

UNIT : mmol/L

Y → mg/dL N→ mmol/L

If your required model is present in this screen then select the model by pressing appropriate number, if not then press Y button to see more models

electrode blocks as per parameters.

Note: In 5thModel Li parameter depends on Na and iCa parameters,

If Na or iCa or both Na & iCa not calibrated, Li won’t be analyzed.

E) Select iCa Unit:

Depending up on user requirement can select iCa measuring units to

mg/dL or mmol/L. By default it is in mmol/L.

Press: MENU

Press 5

↓

ST-200 aQua Operator’s Manual

1. Collect the specimen by venipuncture into a Lithium-Heparin or

2. Mix the specimen by gently inverting and rotating the tube. Do not

3. Analyze specimens within one hour of collection; beyond this time

4. For analysis on Na/K/iCa/Cl/Li/pH analyzer, specimens should be

1. Collect the specimen by venipuncture into an untreated (red-topped)

2. Let blood stand for 20-30 minutes to allow clot formation.

3. Rim the clot with an applicator stick, then centrifuge the tube for

4. Serum may be analyzed immediately or stored at 4ºC for 24 hours or

HANDLING AND COLLECTION

4. Sample Handling and Collection

Warning

other pathogens. Treat all specimens and collection devices and tools as biohazardous materials.

A. Whole Blood

Whole blood specimens should be drawn carefully to avoid hemolysis. Elevated potassium values may indicate a hemolyzed specimen; if hemolysis is suspected, a new sample should be drawn and analyzed. Finger stick methods should be avoided since they can result in elevated potassium values.

: Human body fluid specimens may be contaminated with HIV or

Sodium-Heparin (green-topped) evacuated blood collection tube. For Lithium analysis, a sodium-Heparin (green-topped) tube must be used. Do not use ammonium heparin, EDTA or NaF tubes. Note the time of collection.

shake.

falsely elevated potassium levels may be obtained.

measured within 3-5 minutes.

B. Serum

tube. Fill the tube to at least 2/3 of the total volume. Note the time of collection.

10-15 minutes and transfer the serum to a clean specimen tube.

frozen at -20ºC for up to one week. Sample must be brought to room temperature and mixed well before assaying.

ST-200 aQua Operator’s Manual

1. Collect the specimen by venipuncture into a Sodium-Heparin (green-

2. Mix the specimen by gently inverting the tube. Do not shake.

3. Centrifuge the specimen within one hour of collection. Carefully

4. Analyze plasma samples within 4 hours of collection. Refrigerated

1. Follow standard clinical procedures for collection of random and

2. Refrigerate urine specimens until time of analysis.

3. Centrifuge urine specimens to remove cellular matter, crystals etc.

4. Dilute the urine specimen with one part of the supernatant to 5

To obtain accurate results, samples should be free of any clots, fibrin, etc., which would obstruct sample flow and affect results. The use of a serum clearing agent is strongly recommended.

If a serum separator tube is utilized, care must be taken to avoid inserting the sample probe into the gel layer. This can create obstructions in the sample probe and electrodes.

Serum samples offer no advantage over whole blood specimens for stat analysis but if the sample has to be stored, serum specimens are preferable.

C. Plasma

topped) evacuated blood collection tube. The heparin level should not exceed 15 IU per mL of tube volume. Note the time of collection.

remove the top plasma layer for analysis. Use a Pasteur pipette or a syringe fitted with a blunt-tipped needle for this procedure.

samples must be brought to room temperature and centrifuged prior to analysis.

D. Urine

For complete sample preparation and storage information, the user should refer to the standard clinical chemistry procedures published by NCCLS.

24-hour urine specimens.

parts of urine diluent (1:5). Urine must be diluted.

Do not attempt to analyze undiluted urine.

ST-200 aQua Operator’s Manual

Sodium

(Na+)

135 to 150 mmol/L

Potassium

(K+)

3.5 to 5.0 mmol/L

Ionized Calcium

(iCa++)

1.10 to 1.35 mmol/L

Chloride

(Cl-)

94 to 110 mmol/L

Lithium

(Li+)

0.30 to 1.50 mmol/L

pHpH7.35 to 7.45

Sodium

(Na+)

40 to 220 mmol/L

Potassium

(K+)

20 to 125 mmol/L

Chloride

(Cl-)

100 to 250 mmol/L

E. Expected Values

The values given in below tables (table 1 & 2) are intended to be used only as a guide. Each laboratory or testing site should establish its own range of normal values, taking into account factors such as age, sex, diet and other determinants of electrolyte levels.

Whole Blood, Serum, Plasma

Urine (mmoL/L)

Table 1

Table 2

ST-200 aQua Operator’s Manual

MAINTENANCE

5. Maintenance

The ST-200 aQua electrolyte analyzer requires very little operator maintenance. The only maintenance required is to run the daily cleaning solution every day mandatory. All other maintenance is performed by replacing the components as described in the schedule below. When you wish to perform routine or any other maintenance function, go to the MENU option and Select “Maintenance”. The instrument gets ready for maintenance by priming the fluidic line with air. Follow the menu prompts to perform the replacement.

ST-200 aQua Operator’s Manual

PRINCIPLES OF OPERATION

6. Principles of Operation

A. ISE Theory

Electrolyte measurements in blood products were traditionally performed using flame photometry, in which a sample, diluted with a known concentration of a reference ion (usually lithium or cesium), is aerosolized and passed through a flame which excites the caution. They re-emit the energy as light of different frequencies; the amplitude of this emission is proportional to the ion concentration in the sample. The development of sodium and pH-selective glass, and selective organic compounds for potassium and chloride, has permitted the development of sensors capable of measuring biological fluids directly, throughout the physiological range. These sensors are known as Ion selective electrodes.

The ST-200 aQua electrolyte analyzer measures sodium, potassium, ionized calcium, lithium and chloride in biological fluids, using ion selective electrode technology. The flow-through sodium electrodes contain plasma tube, specially formulated to be sensitive to sodium ions. The flowthrough potassium electrodes employ a plastic tube, incorporating neutral carrier ionophores. The flow-through Ionized Calcium electrodes includes a plastic tube, specially formulated to be selective to Calcium ions. The flowthrough Lithium electrodes includes a plastic tube, specially formulated to be selective to Lithium ions. The flow-through Chloride electrodes includes a plastic tube, specially formulated to be selective to Chloride ions. The flow-through pH electrode includes a plastic tube, specially formulated to be selective to Hydrogen ions. The potential of each electrode is measured relative to a fixed, stable voltage established by the silver/silver chloride reference electrode. An ion selective electrode develops a voltage that varies with the concentration of the ion to which it responds. The relationship between the voltage developed and the concentration of the sensed ion is logarithmic, as expressed by the Nernst equation:

E = Eº + RT ln (aC)

Where:

E = the potential of the electrode in sample solution Eº = the potential developed under standard conditions RT/nF = A temperature dependent “constant” termed the slope (s) n = 1 for sodium, potassium, chloride, lithium and pH n = 2 for calcium ln = Natural log a = Activity coefficient of the measured ion in the solution C = Concentration of the measured ion in the solution

ST-200 aQua Operator’s Manual

Comparative method of measurement is utilized. First, the analyzer measures the potential developed when the sample is aspirated through the electrodes. Next, cal A is aspirated through the electrodes. The difference in the two potentials is related logarithmically to the concentration of ions in the sample divided by their respective concentrations in the calibrant solution. Since the difference in potentials and the concentration of the ions in the calibrant solution are known, the analyzer can calculate the concentration of the ions in the sample solution, in accordance with the Nernst equation, rewritten as:

E-Eº = S ln (Ci (x) / Ci (s)) or Ci(x) = Ci(s) x 10ˆ (E-Eº)/ S

Where: E = ISE potential developed in sample solution

Eº = ISE potential developed in the calibrant solution

S = Electrode Slope calculated during calibration Ci(x) = Concentration of ion “I” in the sample Ci(s) = Concentration of ion “I” in the calibrant solution

“S”, the slope, is determined during calibration using Cal A and B, which are known levels of ions.

The ST-200 aQua electrolyte analyzer aspirates and measures Cal A, followed by Cal B. The ST-200aQua finally aspirates additional Cal “A” solution and measures it. The two Cal “A” readings are compared for drift and each measurement is checked for instability (noise). The slope is calculated from the difference between the second Cal A reading and the Cal B reading. A slope outside the built-in software limits will be flagged and displayed as low or high. The ST-200 aQua electrolyte analyzer will detect excessive drifts or noise and display the appropriate error message.

ST-200 aQua Operator’s Manual

SPECIFICATIONS OF Na/K/iCa/Cl/Li/pH

7. Specifications

Sample : Whole heparin blood, Serum, Plasma,

Cerebrospinal fluid & Diluted Urine

Sample size : 150 micro liters of Whole heparin blood, Serum,

Cerebrospinal fluid, Plasma & 400 micro liters of diluted (1:5) Urine

Method : Direct Measurement by Ion Selective Electrode

(ISE)

Detection Range : Blood

iCa

Li pH : 5.0 – 9.0

Urine

Serum and Plasma

iCa

Li pH : 5.0 – 9.0

: 20.0 – 250.0 mmol/L : 0.2 – 40.0 mmol/L : 0 – 10.0 mmol/L : 20 – 200.0 mmol/L : 0 – 5.0 mmol/L

: 35 - 1000 mmol/L : 50 - 200 mmol/L : 25 - 500 mmol/L

: 20.0 – 250.0 mmol/L : 0.2 – 40.0 mmol/L : 0 – 10.0 mmol/L : 20 – 200.0 mmol/L : 0 – 5.0 mmol/L

If iCa unit is in mg/dL, then the measurement range is 0-40 mg/dL.

Reproducibility (serum) Performed according to a modified NCCLS protocol EP5-T2

ST-200 aQua Operator’s Manual

Reproducibility (expected)

Day to day (n=20)

C.V. <1% C.V. <2% C.V. <2% C.V. <2%

C.V. <2.5% C.V. < +_0.03 C.V. <+-3 C.V. <5%

Reproducibility (expected)

Day to day (n=20)

C.V<5% C.V<5% C.V<5%

URINE Reproducibility Na (Urine STD.) K

: 35 – 1000 mmol/L : 50 – 200 mmol/L : 25 – 500 mmol/L

Analysis Time : 75 sec. (Blood) / 65 sec. (Urine)

Data Storage : 200000+ Patient results, 25000 Urine

results and 100 QC results.

Calibration : Automatic or on Demand.

Output : 128x64 Graphics Display With Y/N

Numeric Keypad 24 column thermal printer

Ambient Conditions : 10-37°C (60-90°F), <85% humidity.

Power : 100/115~VAC, 50-60 Hz, or 220~VAC.

Size & Weight : 17.5 (H) x 28 (W) x 31 (L) cm,

3.9

kg.

ST-200 aQua Operator’s Manual

Diagnostics

Flow

Reagent priming

Prime all

TROUBLESHOOTING

8. Troubleshooting

Introduction

To enhance trouble-free operation of the ST-200 aQua, it is imperative to follow the maintenance schedule outlined under ST-200 aQua maintenance.

When any error messages appear in the display, then refer to the list of “typical error messages” to locate the problem area and proceed to the appropriate section for troubleshooting instructions.

When performing troubleshooting procedures, put the analyzer in MAINTAINANCE mode.

After removing the electrodes, solutions pack or after troubleshooting or performing maintenance, the operator must do reagent priming before calibrating the analyzer. To do this, proceed to the following procedure.

↓

When reagent priming is completed, perform calibration by pressing CALIBRATE Key.

Warning: Human body fluid specimens may be contaminated with HIV or other pathogens.

Treat all specimens, collection devices and analyzer components that may come in contact with specimens as biohazards.

If the appropriate troubleshooting procedures do not correct the observed error, contact your ST-200 aQua distributors.

ST-200 aQua Operator’s Manual

 10mL syringe - 01

 Needles - 03

 Test Tubes - 10



Fuse (2 amp) - 01

 Fuse (5 amp) - 01



Electrode seals - 03

 Welco pump tube - 01

Troubleshooting Kit

Tools to help diagnose and correct problems:

ST-200 aQua Operator’s Manual

 Valve: It is used for aspirating and controlling the calibration solutions

1. While aspirating Calibrant A, the valve’s lock does not move

To waste container

A. Flow Path System

All reagents and samples flow in one direction through the entire flow path system as shown. The flow path is a open loop with one valve, two pump motors and reference housing which ensures that the electrodes will always be kept wet, an important requirement of ISE’s. All flow path connections are simple push-on, air tight connections, which requires no special tools.

Figure 19

Valve functioning:

A and B from the Reagent pack by moving the lock pin as per requirement.

because in ideal state the Calibrant B flow tube is in closed state.

2. While aspirating Calibrant B, the valve opens the Calibrant B flow tube by moving its lock and obviously closes the Calibrant A flow tube.

Note: At an ideal state the CAL-A flow path is in open condition and obviously the CAL-B flow path is in close condition.

If removal of ST-200 aQua components are required during troubleshooting, the component removal order should be as follows:

ST-200 aQua Operator’s Manual

1) Electrode housing.

2) Valve flow connections.

For example, if any electrode block requires replacement, it is necessary to go in MAINTAINANCE MENU for disconnecting flow cell tube which is also called as first pump motor outflow tube and second pump motor inflow tube from the electrode housing. Then carefully remove the electrode housing. If the solutions valve requires cleaning, the operator must remove all of the items in the above list, before removing the solutions valve. To install components on the ST-200 aQua, follow the installation order outlined under installation and replacement.

Troubleshooting is covered in the order that problems are most likely to occur. Approach troubleshooting as a logical sequence of events. Isolate the problematic area to avoid unnecessary component replacement and/or excessive downtime.

PROBLEM AREA TYPICAL ERROR MESSAGES

FLOW ERRORS AIR IN CAL A, AIR IN CAL B, AIR IN

SAMPLE, AIR IN CLEANER, & DRIFT.

ELECTRODES HIGH, LOW, DRIFT, NOISE.

REAGENT PACKS AIR IN CAL A, AIR IN CAL B,

REAGENT PACK LOW, CHANGE PACK, PACK EXPIRED, PLEASE INSERT PACK.

BUBBLE DETECTOR AIR/LIQUID NOT DETECTED.

RFID RFID READ ERROR, CONNECTION

ERROR.

B. Flow Errors

Obstructions or air leaks in the flow path and insufficient sample aspiration will result in error messages such as AIR IN CAL A, AIR IN CAL B, AIR IN SAMPLE & DRIFT. These messages indicate flow problems. A low or empty reagent pack may also cause AIR IN CAL A or AIR IN CAL B messages. If this problem exists, based on usage since the last reagent pack installation refer to reagent pack Consumption in Diagnostics Menu and troubleshooting before proceeding.

If AIR IN CAL B or LIQUID NOT DETECTED! Message appears during a SOLUTION PRIMING or calibration, and reassembled, check to make sure that the electrode blocks are installed right side up and that all electrode

ST-200 aQua Operator’s Manual

Diagnostics

Flow

Reagent priming

Prime Cal A

block connectors or seals are properly installed. Performing this function twice may eliminate the error.

FLOW ERROR (Valve fluidic error or Fluid path error): Flow error depends on following points.

1) Electrode housing.

2) Flow cell.

3) Valve.

4) Pump motors.

5) Reagent pack.

SOLUTION:

1) Electrode housing:

A) Check liquid flow as follows:

Press 1

↓

Press 4

↓

Press 1

↓

Press 1

↓

Both pumps rotates. Check the liquid is flowing through the flow cell tube by following the outflow tube of first pump motor. If liquid does not aspirated properly go to 2nd step Flow cell.

2) Flow cell:

Enter maintenance mode and remove the electrode housing. Check the flow cell, if any dust particles are present in the slot, clean it with daily cleaner or de-ionized water firmly by flushing with syringe. Also, similarly clean deposited protein from electrode blocks with daily cleaner or deionized water firmly by flushing with syringe and reassembled electrode housing carefully.

Note: Do not use the spring needle or plain needle to clean the deposited protein from electrode blocks as it contains different parameters.

Press “N” to maintenance exit. Both pumps rotates. The liquid is aspirated through the flow cell tube by following the outflow tube of first pump motor to check either liquid is flowing properly or not. If liquid is not flowing properly, then check PUMP TUBE as follows:

ST-200 aQua Operator’s Manual

Diagnostics

Maintenance

3) Valve:

Diagnostics

Flow

VALVE TEST

4) Pump motors:

Press 1

↓

Press 2

↓

Both pumps rotates. The liquid is aspirated through the first pump motor and it is removed from electrode housing by second pump motor. Check whether liquid is flowing properly or not. If not, flush or replace pump tubing.

To clean the flow path in valve, use VALVE TEST option.

Press 1

↓

Press 3

↓

Check the liquid flow through valve. Flush and clear valve tubing with deionized water by disconnecting from Reagent pack and first pump motor.

Pump modules are used to generate vacuum in pump tubes for

aspirating liquid. Both Pump module consists of four rollers.

Check whether liquid is flowing IN to the flow cell/reference housing by the first pump motor and also flowing OUT to the waste container by the second pump motor properly or not. If not, flush the pumps tubing by removing from the modules.

Remove pump tubing:

To remove the tubing follow this procedure:

ST-200 aQua Operator’s Manual

 Disconnect the inflow tube (from valve) and outflow tube (to flow cell) of

 Remove the front covers, rollers and pump tubing from the pump



Clean the module base fixed to the chassis.

 Flush the tubing with daily cleaner or de-ionized water.

 Roll the tubing with hand all around by placing on solid work surface.



Clean the outer surface of the tubing with tissue paper.

 Apply the grease to inner surroundings of module base softly.

 Take a four rollers set and apply grease gently to rollers.



Insert grove side of the rollers set to the module base knob.

 Apply grease all around the tubing and then insert it as per the



Close the module with front cover. So that rollers and pump tubing will

Diagnostics

Reagent Pack

Diagnostics

Flow

Reagent priming

Prime All

first pump motor and also disconnect the inflow tube (from reference housing, red stopper) and outflow tube (to the waste container) of second pump motor.

module bases.

Pump tube cleaning and installation:

direction by holding the roller firmly.

lock.

5) Reagent pack: Menu

↓

Press 1

Press 6

↓

(Check complete information & ID of reagent pack) Finally perform reagent priming test as follows:

Press 1

↓

Press 4

↓

Press 1

↓

Press 3

↓

ST-200 aQua Operator’s Manual

D) After priming, proceed for Calibration and check the Calibration Slope. If it is in the following range.

Na K

: Should be in between 35 to 80 mV/ decade

: Should be in between 38 to 80 mV/ decade

iCa++: Should be in between 15 to 50 mV/ decade

Cl Li

: Should be in between 35 to 80 mV/ decade

: Should be in between 30 to 100 mV/ decade

pH : Should be in between 30 to 80 mV/ decade

Then go for sample analysis or repeat calibration. After multiple calibration failure, replace the faulty electrode block.

C. Electrode Assembly

The electrode block assembly should be replaced after 6 months of use. ST-200 aQua guarantees this item’s performance for 6 months of use, but the frequency of replacement may depend on your sample volume or sample type (volume of lipemic high protein samples may necessitate more frequent changes of the electrode block assembly). ST-200 aQua customers testing 100 or more patient samples per week should replace the electrode block assembly after 6 months of use.

The electrode block assembly should be checked to prevent any leakage. At the same time, the electrode block pins and pogo pins should be inspected to make sure they are dry and clean, including the reference electrode pin and female connector, if low or erratic readings occur.

Electrodes with low calibration values (below 35 for Na/K/Li/Cl and below 15 for iCa), Drift, or Noise messages may indicate electrodes block failure. Parameter with HIGH calibration values messages most often indicate an electrode block assembly/disposable reference electrode failure.

For Na/K/iCa/Cl/Li/pH analyzer, when the electrode housing is removed for electrode replacement, maintenance, troubleshooting, etc, wait for 10 minutes after re-installation to ensure proper electrode temperature.

A Calibration values (Slopes) of the electrodes should fall within a range

of 35 to 80 for Na/Cl, 38 to 80 for K, 15 to 50 for iCa, 30 to 100 for Li & 30 to 80 for pH. If they fall outside of this range, the out-of-range values **** for “Na”, “pH”, “K”, “iCa”, “Cl”, “Li” will be flagged. The analyzer should be recalibrated. At the end of the calibration cycle, the slope values will be displayed for each electrode. The ST-200 aQua will permit sample analysis only for the electrodes that are calibrated successfully.

If Na or iCa or both Na and iCa not calibrated, Li won’t analyzed, because Li parameter depends on Na and iCa parameters.

B A Na LOW, DRIFT message indicates that an additional prime cycle

may be necessary to condition the sodium electrode.

ST-200 aQua Operator’s Manual

C A K LOW, DRIFT message may indicate that the block 1 needs replacing.

Before doing so, perform a daily cleaning cycle, as described under DAILY CLEANER. Next, perform a calibration. If the potassium calibration value remains low, replace block.

D A LOW, DRIFT message for chloride or Ionized Calcium only, may

indicate that replacement of the particular block is necessary. Before doing so, try performing a daily Cleaning, as described under DAILY CLEANER. Next, perform a calibration. If the calibration value remains low, replace the particular electrode block.

E If all parameters have low or high calibration values, the problem is

most likely with the electrode assembly or the reference electrode (on the Na/K/iCa/Cl/Li/pH analyzer, the problem may be the disposable reference electrode). It is also possible that an incorrect reagent pack is being used, the ST-200 aQua will not calibrate successfully.

F If drift messages appear for all parameters, there is most likely a flow

problem (refer to flow problems) or electrode stack assembly problem (refer to electrode stack assembly). Also, inspect the electrode blocks pins, including the reference electrode pin, to ensure that they are dry and clean. After reassembly, the analyzer should be primed and calibrated.

D. Reagent Pack

AIR IN CAL A, AIR IN CAL B, REAGENT PACK LOW, INSUFFICIENT PACK PLEASE REPLACE & EMPTY PACK PLEASE REPLACE messages may indicate that the reagent pack is empty or low.

The ST-200 aQua has an RFID (Radio Frequency Identification System) which keeps track of the reagent pack usage. The ST-200 aQua will indicate the availability of reagents in a decreasing manner i.e., 100% to 0% at every analysis.

When 10-15% of the reagent pack has remained in the reagent pack, instrument will indicate INSUFFICIENT PACK PLEASE REPLACE till it reaches 5%. Below 5% the instrument will displays EMPTY PACK PLEASE REPLACE.

E. Bubble Detector

The bubble detector detects the difference between liquid and air, which is important for proper sample positioning in the ST-200 aQua. It consists the flow cell at the top to drop the sample by the pipette. To verify performance, proceed to *DIAGNOSTICS* followed by sub menu HARDWARE and perform SAMPLE DETECTOR test.

In sample detector test, if liquid or air is not detected, clean the Bubble detector with diluted Sodium Hypochlorite (NaClO) or Daily cleaner or deionized water. Then also if not solved, replace bubble detector.

ST-200 aQua Operator’s Manual

1. To verify that the printer is turned on, enter the SETUP MENU and

2. Check the printer mechanism for any paper obstructions in the

3. If steps 1 and 2 are successful, but the printer remains inactive,

1 Press “Y” to SYSTEM NOT CALIBRATED PLEASE CALIBRATE.

2 Calibrant B and Calibrant A from the solutions pack are aspirated

3 ANALYZE SAMPLE indicates a successful calibration. If an error is

Note: Make sure that the flow cell cover should be kept on the top of the flow cell/bubble detector if the analyzer is kept in ideal state to protect from the dust.

Figure 20 Figure 21

F. Printer

If the ST-200 aQua printer fails to print, attempt the following procedures:

check PRINTER ON/OFF.

printer head area. Remove any obstructions if possible, without damaging the printer assembly or paper tear bar.

remove the analyzer power cord for ten seconds, and then reinstall the power cord. Press the paper advance button. The printer head should move across the paper and the paper should advance forward.

If the printer continues to function abnormally, contact your ST-200 aQua distributor.

Performance Verification

Periodically, the laboratory may want to verify the analyzer’s performance. ST-200 recommends the following procedures:

CALIBRATION – Automated

and measured internally.

displayed, refer to instructions in the troubleshooting section.

ACCURACY

1. Calibrate the analyzer.

2. Using the quality control kit, test each control level three times and

3. Refer to the published ranges in the “Expected Value Chart”.

4. The mean value (each day) for each parameter should fall within the

1 Collect 5 patient samples.

2 Analyze each sample 10 times consecutively on the ST-200 aQua

3 Calculate the mean, standard deviation and C.V. for each sample.

4 Compare the C.V. for sodium, potassium and chloride and the S.D.

1 Collect 20 patient samples (serum or plasma is preferable for

2 Measure each sample on the ST-200 aQua and the reference

3 Calculate the difference (Reference analyzer value ST-200 aQua

4 The laboratory director should determine acceptability.

record the data. Repeat this sequence for a total of 3 days.

published ranges.

PRECISION

and record the data.

to specifications.

ST-200 aQua Operator’s Manual

CORRELATION

Use the ST-200 aQua and a reference analyzer (ISE, flame photometer

or other) in the laboratory.

Na/K/iCa/Cl/Li/pH) and split in half.

analyzer.

value) for each sample and record.

ST-200 aQua Operator’s Manual

DISPLAY MESSAGES

Display Messages

ANALYZE SAMPLE Perform Whole heparin blood, serum,

CSF Sample analysis.

ANALYZE URINE Perform diluted urine Sample analysis.

ANALYZE QC Perform QC sample analysis.

AIR DETECTED Air detected in Sampler detector test.

AIR NOT DETECTED Air not detected in Sampler detector test.

AIR IN CLEANER Cleaning solution not detected correctly.

AIR IN SAMPLE Insufficient sample.

AIR IN CAL A Cal A not detected correctly.

AIR IN CAL B Cal B not detected correctly.

ASPIRATING Sample is being drawn into probe.

AUTO STANDBY Auto standby on/ off

CALIBRATION FREQUENCY Set auto-calibration time.

SIPPING FREQUENCY Set auto-sipping time.

CALIBRATION SLOPE Allows operator to display last calibration

Values.

CALIBRATE Allows operator to calibrate analyzer.

CALIBRATING Analyzer is calibrating.

CAL A CONCENTRATION CAL A concentration values will be

displayed.

CAL B CONCENTRATION CAL B concentration values will be

displayed.

SOLUTION LEFT Percentage reagent left in Reagent pack.

ST-200 aQua Operator’s Manual

INCOMPATIBLE PACK Pack is not suitable for the instrument.

CLEANING… Analyzer is performing daily cleaning

CLEANING CYCLE PERFORMED … Appears after daily cleaner process over.

SYSTEM UNCALIBRATED PLEASE CALIBRATE

Na/K/iCa/Cl/Li /pH HIGH… Na/K/iCa/Cl/Li /pH result obtained

is higher than the preset normal range

Na/K/iCa/Cl/Li /pH LOW… Na/K/iCa/Cl/Li /pH result obtained is

lower than the preset normal range

DATE/TIME Allows operator to change date and time

DAILY CLEANER Allows operator to perform daily cleaning

DIAGNOSTICS Allows operator to check key analyzer

Functions.

DISTRIBUTOR ID: Allows the operator to check

distributor ID

DRIFT Na/K/iCa/Cl/Li /pH Na/K/iCa/Cl/Li /pH mV drifting from

First analysis.

ENTERING STANDBY Analyzer will go into standby mode in

60 sec.

EXIT- ANALYZE SAMPLE Sample not detected correctly AIR IN SAMPLE Sample not detected PRESS ‘N’ TO EXIT

PACK EXPIRED Check the expiry date of reagent pack

EXIT CALIBRATION Exit from calibration

EXIT DAILY CLEANING Exit from daily cleaning

INSTALLED ON: Check the installation date INVALID PACK Message will appear when the reagent

pack ID is invalid. LEVEL 1 Allows the operator to select the desired LEVEL 2 QC level analysis LEVEL 3

ST-200 aQua Operator’s Manual

LIQUID DETECTED Message will appear when the liquid is

detected in sample detector test.

LIQUID NOT DETECTED Message will appear when the liquid is

not detected in sample detector test.

LOT NO: Allows the operator to check lot number

MENU Menu selection.

MAINTENANCE… Instrument is in maintenance mode.

Na/K/iCa/Cl/Li /pH Appears when power is connected or

restored after Interruption

POSITIONING SAMPLE Message will appear during sample

positioning.

PROBE IN SAMPLE? PRESS ‘Y’ TO PROCEED PRESS ‘N’ TO EXIT

PLEASE INSERT PACK Message will appear when the system has

PRIMING CAL A

PRIMING CAL B

PRIMING ALL CAL A & CAL B fluid line is being primed

PRINT LAST 600 SAMPLE RESULTS Allows operator to print 600 stored

PRINT LAST 100 QC SAMPLE RESULTS Allows operator to print 100 stored QC

Requests operator to confirm that probe is

in blood.

not detected reagent pack.

CAL A fluid line is being primed.

CAL B fluid line is being primed.

blood results

Results

PRINT LAST 100 URINE RESULTS Allows operator to print 100 stored

urine Results

PRINTER Allows operator to turn printer function on or

Off.

PRINT- mV Allows operator to select if mV is selected.

The mV readings will get flagged.

ST-200 aQua Operator’s Manual

PRINT STORED RESULTS Allows operator to display last sample

results or print stored results

PROBE IN SAMPLE Requests operator to confirm that probe

is in sample.

PROBE IN CLEANER Requests operator to confirm that probe

is in Daily Cleaning Solution

PUMPING AIR Message will appear when air pumps

PUMPING CAL A Message will appear when CAL A reagent

gets pumped

PUMPING CAL B Message will appear when CAL B reagent

gets pumped.

PUMP CAL ERROR Failure of Pump cal Test.

PUMPING LIQUID Message will appear when liquid is

pumped

PUMP SPEED = FAST Allows the operator to set the pumping

speed fast

PUMP SPEED = SLOW Allows the operator to set the pumping

speed slow

REAGENT CONSUMPTION Allows the operator to check the quantity

of the reagent solution consumed

REAGENT PACK Allows operator to check the reagent

pack details.

REAGENT PACK CONSUMPTION Allows operator to display % pack

expended

REGEANT PACK ID Allows the operator to check the pack ID

REAGENT PACK INFO Allows the operator to check the pack

information

REMOVE SAMPLE FROM PROBE Requests operator to remove sample from

probe. RFID READ ERROR When there is an error in RFID reading.

SAMPLE DETECTOR TEST Message will appear during sample detect

test

ST-200 aQua Operator’s Manual

NORMAL RANGES Used to set the Na/K/iCa/Cl/Li/pH

sample limits

ANALYZE TYPE Allows operator to select the sample type.

Eg: SAMPLE/URINE/QC

ST-200 aQua The first displayed message.

SENSOR CAL A –mV Allows the operator to display the mV

readings of CAL A reagent selected.

SENSOR CAL B –mV Allows the operator to display the mV

readings of CAL B reagent selected.

SYSTEM UNCALIBRATED This allows the operator to calibrate. If PLEASE CALIBRATE… the system is not calibrated; this

message will get displayed on the screen.

STANDBY Appears when Analyzer is in Standby

mode.

NO OF SAMPLES: Allows the operator to check the total

samples Performed.

ST-200 aQua Operator’s Manual

APPENDICES

A. Warranty

Warrants the electrolyte analyzer will be free of defects in material and workmanship for a period of twelve months from the date of purchase, except for those parts or materials which are consumed or expended in normal use. In the case of consumables or expendables, the warranty time period shall be usage time prescribed in the operator’s manual providing such consumable or expendable is used prior to any “install by” or “expiration date”. The warranty is only applicable for ST-200 aQua under normal operating conditions and maintained in accordance with the instructions in the operator’s manual and when not having been subjected to accident, alteration, or misuse. In the event of failure within the warranty period, ST-200 aQua will repair or replace any Analyzer returned. ST-200 aQua reserves the right to ask for proof of date of purchase, such as original invoice and / or maintenance records.

Representations and warranties made by any person including dealers, representatives and employees, which are inconsistent or in conflict with, or in addition to, the terms of this warranty shall not be binding upon ST-200 aQua unless in writing and signed by one of its officers.

* * * * * * *

ST-200 a ua

Auto Queue Universal Analyzer

Plot No: 3, Export Promotion Industrial Park, Pashamylaram, Sangareddy (Dist), Hyderabad - 502307. Telangana, INDIA. Telephone : +08455 - 223400 web : www.sensacore.com

Sensa Core ST-200 aQua Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual