USER MANUAL

Date of last revision:

INS00079 09/2023
CC/IFU/042/23/H

Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ

Contents
Copyright ........................................................................................................................................................... 6

Disclaimer .......................................................................................................................................................... 6

1 Safety instructions and precautions ..................................................................................................... 7

1.1 Usage of this manual .................................................................................................................................. 7

1.2 Symbols ...................................................................................................................................................... 7

1.2.1 Symbols used in this manual....................................................................................................... 7
1.2.2 Keywords used in this manual .................................................................................................... 7
1.2.3 Symbols used on the instrument and accessories ...................................................................... 8

1.3 Safety instructions .................................................................................................................................... 10

1.3.1 Safety instructions for installation ............................................................................................ 10
1.3.2 Safety instructions for transportation ...................................................................................... 10

1.4 Precautions ............................................................................................................................................... 11

1.4.1 Precautions prior to operation ................................................................................................. 11
1.4.2 Precautions during operation ................................................................................................... 11
1.4.3 Precautions when preparing blood and urine samples ............................................................ 12
1.4.4 Precautions for maintenance and storage after usage ............................................................. 12
1.4.5 Precautions for waste disposal ................................................................................................. 12

2 Introduction ....................................................................................................................................... 13

2.1 Intended use of the instrument ................................................................................................................ 13

2.1.1.1 EC cartridge ..................................................................................................................... 13
2.1.1.2 EC cartridge plus iCa ........................................................................................................ 13

2.2 Measurement and calibration methods ................................................................................................... 14

2.2.1 Measurement ........................................................................................................................... 14
2.2.2 Calibration ................................................................................................................................. 14
2.2.3 Measurement evaluation.......................................................................................................... 14

2.3 Scope of supply ......................................................................................................................................... 15

2.4 Description of the instrument and accessories ......................................................................................... 16

2.4.1 Instrument ................................................................................................................................ 16
2.4.2 EC cartridge ............................................................................................................................... 19

2.5 Specifications ............................................................................................................................................ 20

2.5.1 General specifications of the instrument and accessories ....................................................... 20
2.5.2 Environmental parameters ....................................................................................................... 21
2.5.3 Measured parameters .............................................................................................................. 21
2.5.4 Sample parameters ................................................................................................................... 22
2.5.5 Materials and supplies .............................................................................................................. 22

3 User interface guide ........................................................................................................................... 23

3.1 General information ................................................................................................................................. 23

3.2 Levels of access......................................................................................................................................... 23

3.3 Keyboard .................................................................................................................................................. 24

EC 90 User Manual 1
 CONTENTS

3.4 Barcode reader ......................................................................................................................................... 25

3.5 Button design ........................................................................................................................................... 27

3.5.1 Regular screen buttons ............................................................................................................. 27
3.5.2 Workflow status buttons .......................................................................................................... 27
3.5.3 Selection buttons ...................................................................................................................... 28

3.6 Top bar ..................................................................................................................................................... 28

3.7 Bottom bar ............................................................................................................................................... 28

3.7.1 System status ............................................................................................................................ 29
3.7.2 System notice ............................................................................................................................ 29

4 Operation .......................................................................................................................................... 30

4.1 Start-up..................................................................................................................................................... 30
4.1.1 Installation and incoming inspection ........................................................................................ 30
4.1.2 Tube engagement and clip removal ......................................................................................... 31
4.1.3 Connecting the instrument to main power .............................................................................. 34
4.1.4 Guided start-up ......................................................................................................................... 35
4.1.5 Inserting printer paper (optional) ............................................................................................. 40

4.2 Economy mode ......................................................................................................................................... 41

4.2.1 Interval settings ........................................................................................................................ 41
4.2.2 Manual activation ..................................................................................................................... 42
4.2.3 System reinitialization ............................................................................................................... 43

4.3 Measurement ........................................................................................................................................... 44

4.3.1 Main menu overview ................................................................................................................ 44
4.3.1.1 Device status button ....................................................................................................... 45
4.3.1.2 EC cartridge status .......................................................................................................... 45
4.3.1.3 Parameter status ............................................................................................................. 46
4.3.1.4 Smart calibration ............................................................................................................. 46
4.3.2 Performing measurements ....................................................................................................... 47
4.3.2.1 Single measurement ....................................................................................................... 47
4.3.2.2 Serial measurement ........................................................................................................ 52

4.4 Results ...................................................................................................................................................... 53

4.4.1 Results menu overview ............................................................................................................. 53
4.4.1.1 Results table .................................................................................................................... 53
4.4.1.2 Electrolyte levels ............................................................................................................. 54
4.4.1.3 Error flags ........................................................................................................................ 54
4.4.2 Printing data.............................................................................................................................. 56
4.4.3 Filtering data ............................................................................................................................. 57
4.4.4 Exporting and deleting data ...................................................................................................... 59
4.4.5 Exporting data via LIS ................................................................................................................ 61

4.5 Quality Control ......................................................................................................................................... 62

4.5.1 QC concept ................................................................................................................................ 62
4.5.2 QC menu overview.................................................................................................................... 63
4.5.3 QC materials.............................................................................................................................. 64
4.5.3.1 Material screen overview ................................................................................................ 64
4.5.3.1.1 Material table ......................................................................................................... 64
4.5.3.1.2 Adding control solutions......................................................................................... 65
4.5.3.1.3 Modifying control solutions ................................................................................... 66

EC 90 User Manual 2
 CONTENTS

4.5.3.1.4 Deleting control solutions ...................................................................................... 67

4.5.4 Performing QC .......................................................................................................................... 68
4.5.5 QC results .................................................................................................................................. 71
4.5.5.1 Results screen overview .................................................................................................. 71
4.5.5.1.1 QC results table ...................................................................................................... 71
4.5.5.1.2 QC electrolyte levels and out-of-control results .................................................... 72
4.5.5.1.3 Levey-Jennings chart .............................................................................................. 73
4.5.5.1.4 Data processing ...................................................................................................... 76
4.5.5.1.5 Error flags ............................................................................................................... 76

4.6 Calibration ................................................................................................................................................ 77

4.6.1 Calibration concept ................................................................................................................... 77
4.6.2 Calibration menu overview ....................................................................................................... 78
4.6.3 Performing calibrations ............................................................................................................ 80
4.6.4 Calibration results ..................................................................................................................... 81
4.6.4.1 Slope screen overview .................................................................................................... 81
4.6.4.1.1 2P CAL results table ................................................................................................ 81
4.6.4.1.2 Slope values and statistics ...................................................................................... 82
4.6.4.1.3 Data processing ...................................................................................................... 82
4.6.4.1.4 Error flags ............................................................................................................... 83
4.6.4.2 1P screen overview ......................................................................................................... 84
4.6.4.2.1 1P CAL results table ................................................................................................ 84
4.6.4.2.2 Voltage values and statistics .................................................................................. 85
4.6.4.2.3 Data processing ...................................................................................................... 85
4.6.4.2.4 Error flags ............................................................................................................... 86

5 Maintenance ...................................................................................................................................... 87

5.1 Maintenance menu overview ................................................................................................................... 87

5.2 Decontamination and cleaning ................................................................................................................ 88

5.2.1 General information ................................................................................................................. 88
5.2.2 Recommended decontaminants ............................................................................................... 89

5.3 Fluidic schematic ...................................................................................................................................... 90

5.4 Routine maintenance ............................................................................................................................... 91

5.4.1 Daily .......................................................................................................................................... 91
5.4.1.1 Checking the EC cartridge status ..................................................................................... 91
5.4.1.2 Checking the printer paper ............................................................................................. 92
5.4.1.3 Cleaning the instrument surfaces ................................................................................... 92
5.4.1.4 Cleaning the touch screen ............................................................................................... 93
5.4.1.5 Cleaning the sample aspiration unit................................................................................ 94
5.4.2 Weekly ...................................................................................................................................... 95
5.4.2.1 Checking the air tube for crystallisation ......................................................................... 95

5.5 Periodic maintenance ............................................................................................................................... 96

5.5.1 Annually .................................................................................................................................... 97
5.5.1.1 Replacement of the peristaltic pump tube ..................................................................... 97
5.5.1.2 Replacement of the needle block ................................................................................. 101
5.5.1.3 Replacement of the valve tubes .................................................................................... 105
5.5.2 3-year service .......................................................................................................................... 113

5.6 On-demand maintenance ....................................................................................................................... 115

EC 90 User Manual 3
 CONTENTS

5.6.1 Changing the EC cartridge ....................................................................................................... 115

5.6.2 Changing the EC Biosensor ..................................................................................................... 120
5.6.2.1 Initiate wetting routine ................................................................................................. 126
5.6.3 Cleaning the tubing ................................................................................................................. 127
5.6.4 Cleaning the EC cartridge compartment ................................................................................. 134
5.6.5 Replacing printer paper rolls................................................................................................... 136
5.6.6 System and performance tests ............................................................................................... 137

5.7 Records ................................................................................................................................................... 138

5.8 Shutdown for long-term storage ............................................................................................................ 140

5.8.1 Pre-shutdown maintenance ................................................................................................... 140
5.8.2 Performing shutdown ............................................................................................................. 141
5.8.3 Post-shutdown maintenance .................................................................................................. 144

6 Setup ............................................................................................................................................... 148

6.1 Set-up menu overview ............................................................................................................................ 148

6.2 Operation settings .................................................................................................................................. 149

6.3 Printer ..................................................................................................................................................... 152

6.4 LIS 154

6.5 System .................................................................................................................................................... 155

6.6 Users ....................................................................................................................................................... 159

6.6.1 Adding user accounts .............................................................................................................. 159
6.6.2 Modifying user accounts ......................................................................................................... 160
6.6.3 Deleting user accounts ............................................................................................................ 161

6.7 SW Update.............................................................................................................................................. 162

6.8 QC settings ............................................................................................................................................. 163

6.9 Info ......................................................................................................................................................... 166

7 Troubleshooting ............................................................................................................................... 167

7.1 General guidance ................................................................................................................................... 167

7.2 Performing troubleshooting ................................................................................................................... 168

7.2.1 Parameter status warnings ..................................................................................................... 169
7.2.2 Events indicated by error and warning pop-ups ..................................................................... 170
7.2.3 Events related to analyser processes ...................................................................................... 173
7.2.4 Events related to parameters ................................................................................................. 176
7.2.5 Events related to out-of-control measurements .................................................................... 178

8 Analytical performance .................................................................................................................... 181

8.1 Precision ................................................................................................................................................. 181

8.1.1 Plasma ..................................................................................................................................... 181

8.2 Accuracy ................................................................................................................................................. 181

8.2.1 Plasma – NIST .......................................................................................................................... 181
8.2.2 Aqueous – Gravimetry ............................................................................................................ 182
8.2.3 Urine ....................................................................................................................................... 183

8.3 Linearity .................................................................................................................................................. 184

EC 90 User Manual 4
 CONTENTS

8.3.1 Plasma ..................................................................................................................................... 184

8.3.1.1 Na+ plasma linearity ...................................................................................................... 184
8.3.1.2 K+ plasma linearity ......................................................................................................... 185
8.3.1.3 iCa2+ plasma linearity .................................................................................................... 185
8.3.1.4 Cl- plasma linearity ........................................................................................................ 186
8.3.2 Aqueous .................................................................................................................................. 186
8.3.2.1 Na+ aqueous linearity .................................................................................................... 186
8.3.2.2 K+ aqueous linearity ...................................................................................................... 187
8.3.2.3 iCa2+ aqueous linearity .................................................................................................. 187
8.3.2.4 Cl- aqueous linearity ...................................................................................................... 188
8.3.3 Urine ....................................................................................................................................... 188
8.3.3.1 Na+ urine linearity ......................................................................................................... 188
8.3.3.2 K+ urine linearity ............................................................................................................ 189
8.3.3.3 Cl- urine linearity ........................................................................................................... 189

8.4 Interferences........................................................................................................................................... 190

EC 90 User Manual 5
 Copyright
Copyright © 2022, Erba Lachema s.r.o. All rights reserved.

This manual contains material proprietary to Erba Lachema and is proteced by copyright laws.
Therefore, the manual and any of its content must not be modified, reproduced, transmitted or
translated without the written consent of Erba Lachema.

Disclaimer
While every effort has been made to ensure the accuracy and completeness of the provided
information, it cannot be guaranteed that the manual is free of errors. Therefore, Erba Lachema shall
not be held responsible and disclaims all liability for any loss or damage resulting from errors or
ommissions in this document.

The content and specifications of the manual are subject to change without prior notice.

Any misusage or unspecified modifications to the instrument will void the warranty and may result in
injuries. All operators are urged to carefully read and follow the safety instructions and precautions
which are intended to protect them against injuries and the instrument from damage.

EC 90 User Manual 6
 SAFETY INSTRUCTIONS AND PRECAUTIONS

1 Safety instructions and precautions

1.1 Usage of this manual
This manual provides all information and data required for the optimal operation and maintenance of
the EC 90 series. The manual only shows an exemplary product of the series, therefore the described
functions and illustrations may differ from those on your device.

Attention! Please read this manual carefully before starting operation!

Store the manual in a safe place accessible at all times for future reference.

Hint A table of contents at the beginning of this manual and each chapter enables quick access to
information.

1.2 Symbols

1.2.1 Symbols used in this manual

The following symbols are used to enhance readability of this manual:

Biological Risks
All sections/text passages marked with this symbol describe processes which
involve working with potential biological hazards.

1.2.2 Keywords used in this manual

Hint Useful hints and tips are marked with this keyword.

Link This keyword indicates instructions which are linked with actions in the user
interface.

Read Please read first / Path

If this keyword is shown the reader is referred to another chapter or section of
this manual.

EC 90 User Manual 7
 SAFETY INSTRUCTIONS AND PRECAUTIONS

Attention! All sections/text passages marked with this word identify operations and/or
certain conditions and hazards that may result in damage or malfunction.

Warning! All sections/text passages marked with this word include information which
contribute to the prevention of physical injury.

1.2.3 Symbols used on the instrument and accessories

The following standardised symbols are used to label the instrument and EC cartridges:

Attention (caution)
Read all safety instructions and precautions.

See Instructions for Use

Read the user manual before operation.

Biological Risks
Certain biological risk is related to this product due to the
nature of materials which are used for analyses.

Classified collection of electrical and electronic equipment

The product should not be disposed of together with regular household
waste at the end of its service life. The disposal and recycling of waste must
comply with with local and national regulations.

In vitro diagnostic medial device

The product is registered as in-vitro diagnostic medical device.

CE marking of conformity
Device complies with the Regulation (EU) 2017/746 on IVD MD

Serial number
Denotes the serial number of the product to enable specific identification.

Manufacturer
Indicates the manufacturer of the product.

Catalogue Number
Denotes the manufacturer’s catalog number to enable identification of the
product.
Lot Number
Denotes the manufacturer’s batch code to enable identification of the batch
or lot.

EC 90 User Manual 8
 SAFETY INSTRUCTIONS AND PRECAUTIONS

Storage Temperature
Store the product at the specified temperatures.

Expiry Date
Indicates the date after which the product must not be used.

Content is sufficient for <n> tests

The product contents are sufficient for the given number of tests.

Humidity Limitation
Indicates the range of humidity to which the medical device can be safely
exposed.

EC 90 User Manual 9
 SAFETY INSTRUCTIONS AND PRECAUTIONS

1.3 Safety instructions

1.3.1 Safety instructions for installation

• Select a suitable and secure location for installing the instrument. Do not place the device on
uneven or unstable surfaces. A drop impact may cause damage to the device or lead to injuries.
• Do not install the device in proximity to gas outlets.
• Use only the genuine power cords supplied with the instrument.
• Use only AC power provided by the mains (grounded standard socket). Overvoltage may
damage the device and increase the risk of fire. Ensure that the device is only supplied with a
mains voltage in the accepted range of 100 – 240 V. It is recommended to use a UPS backup
power supply in order to ensure operation of the analyzer during power outages or temporary
losses of voltage, thus allowing for proper switching off the analyzer without the risk of loss of
measured results
Attention! • It is recommended to utilize a supply network with a TT system or a TN system.
• Do not place objects on the instrument. The resulting loads might lead to malfunctioning and
the drop impact of heavy items could damage the device or lead to injuries.
• Do not use damaged power cords. These pose serious hazards such as electric shock, burns
and risk of fire.
• The instrument may only be connected to approved devices that do not harm or endanger the
operator.
• The device may not be disassembled, repaired or modified by operators.
• Never touch the power plug with wet hands. Do not allow moisture to penetrate the
instrument. Avoid liquids and other moisture sources while installing the device.
• Ensure that the power cord is only plugged into grounded sockets. Use a socket that is easily
accessible.

1.3.2 Safety instructions for transportation

• Dropping the instrument while carrying or during transport may cause damage to the
device.
Attention!
• The instrument must be protected against shock.
• Use the original packaging for transportation.

Before switching off the instrument, a proper shutdown procedure must be performed. For
Attention!
detailed instructions, refer to the section Shutdown for long-term storage on page 140.

To move the instrument, flip the toggle switch to the OFF position and unplug the power cord.
Disconnect the barcode scanner, if present. Firmly grip the bottom of the device with both hands and
lift carefully.

EC 90 User Manual 10
 SAFETY INSTRUCTIONS AND PRECAUTIONS

1.4 Precautions
Any serious incident that has occurred in relations to the device shall be reported to the manufacturer
and the competent authorities of the Member State in which the user and/or the patient is established.

1.4.1 Precautions prior to operation

• Samples must be stored adequatly before testing to protect the samples from
contamination and denaturation.
• The instrument should be checked for dust and other contaminants at regular intervals.
Attention! • The device may only be installed in clean, dry and well-ventilated areas.
• Keep the instrument away from heat–radiating devices (e.g. heaters) and devices with
strong electromagnetic radiation. These may cause thermal distortion of plastic parts and
could adversely affect the measurement performance.

1.4.2 Precautions during operation

• The instrument is intended to be used by healthcare professionals such as medical
doctors and well–trained laboratory personnel.
• If the instrument is used in a manner not specified by the manufacturer, the protection
provided by the device may me impaired and the warranty may be lost.
• Avoid external influcences such as vibration or shock during measurement.
• Do not open any flaps of the instrument during measurement.
• Avoid spilling liquids onto the instrument. Do not allow liquids to penetrate the interior
of the insturment. If the device has gotten wet, immediately pull the power plug and
contact the technical support team.
• Always wear protective gloves to prevent potential infection.
• Do not move the instrument during operation.
• Use only the genuine power cords that are supplied with the instrument. Do not unplug
the device during operation.
• While a biosensor is installed, the instrument must be operated continuously to ensure
Attention! its performance. If the environmental conditions do not guaranty a continuous power
supply, please use an uninterrupted power source (UPS).
• Ensure that the EC cartridge is inserted correctly.
• In case of malfunctioning do not attempt to disassemble the device. Please contact your
dealer or the technical support team.
• Before inserting a new EC cartridge ensure that the RFID chip has not been removed . If
the RFID tag is missing, the device will not be able to indentify the cartridge and
measurements cannot be performed.
• The measuring mode can only be cancelled before manual or automatic sample
aspiration. To cancel a measurement (e.g. due to wrong parameter or sample type
selection) simply close the sample cover. Once the sample has been aspirated, the
measurement cannot be cancelled.
• Use the device only at ambient temperatures of + 15 °C to + 35 °C and relative humidities
of 15 % to 90 %.

Attention! Before switching off the instrument, a proper shutdown procedure must be performed.
For detailed instructions, refer to the section Shutdown for long-term storage on page
140.

EC 90 User Manual 11
 SAFETY INSTRUCTIONS AND PRECAUTIONS

1.4.3 Precautions when preparing blood and urine samples

• Whole blood samples may be directly measured or further processed to create plasma
and serum samples.
• Whole blood samples must be measured within 30 minutes after collection or chilled in
an ice-water slurry.
• For the reporting of ionized calcium in whole blood samples, it is advised to store syringes
at 4 °C for a maximum of four hours.
Attention!
• Take care to prevent hemolysis in blood samples during handling and processing of
specimens
• Urine must be diluted 1:3 (1 part urine and 2 parts diluent v/v) to permit accurate
measurements. Use only the recommended urine diluent.
• Use only sample containers spray-coated with sodium heparin. Do not use EDTA or
citrate as anticoagulants. This may result in incorrect measurement results.

1.4.4 Precautions for maintenance and storage after usage

• To fully disconnect the instrument from the mains supply, flip the toggle switch to the off
position and unplug the power cord from the socket.
• The mains safety fuses may only be replaced by qualified electricians or other experts.
• Do not store the instrument in humid locations or areas that are exposed to humidity or
temperatures above or below the specified range.
• Store the device on even and stable surfaces, protected against vibrations and shock.
• The instrument must not be stored together with chemicals or gases.
Attention! • The device shall be stored at ambient temperatures of + 2 °C to + 35 °C and relative
humidities of 15 % to 90 %.
• Contaminants shall be removed with recommended disinfectants using damp cloths such
as wipes or gauze pads. Always wear protective gloves while cleaning.
• Do not use substances such as benzene or acetone. These chemicals may cause damage
to the instrument.
• Follow the storage instructions specified in this manual. Observe all safety precautions
when moving the device.

• Pay attention to all warning labels on the device.

• Device components may contain biological fluids, which potentially pose an infection
risk. Wear protective gloves!

1.4.5 Precautions for waste disposal

• The instrument and its accessories should not be disposed of together with regular
Attention! household waste at the end of their service life.
• The disposal and recycling of waste must comply with with local and national regulations.

• Specimens may be contaminated with pathogenic microorganisms (bacteria, viruses etc.)

which can cause infectious diseases such as hepatitis B. All samples must therefore be
considered as potentially infectious and should be handled with care.
• Sample containers must be handled according to the national regulations for safe
treatment and disposal of medical waste.

EC 90 User Manual 12
 INTRODUCTION

2 Introduction
2.1 Intended use of the instrument
Automatic analyser intended for in vitro quantitative determination of specific electrolytes in whole
blood, serum, plasma and diluted urine. The instrument is able to determine the concentration of so-
dium (Na+), potassium (K+), ionized calcium (iCa2+) and chloride (Cl-). The results for tested electrolytes
can be used for screening, monitoring and diagnosis of diseases associated with ionic imbalance as
kidney disease, disorders of acid-base balance, nutritional disorders and digestive tract function. For
professional use in clinical laboratory only.

The parameter settings depend on the selected cartridge:

2.1.1.1 EC cartridge
IVD kit intended for calibration and quantitative determination of sodium (Na+), potassium (K+) and
chlorides (CI-) on the EC 90 analyzer. Intended for screening, monitoring and diagnosis of diseases
associated with ionic imbalance as kidney disease, disorders of acid-base balance, nutritional disorders
and digestive tract function. For professional use in clinical laboratory only.

2.1.1.2 EC cartridge plus iCa

IVD kit intended for calibration and quantitative determination of sodium (Na+), potassium (K+),
ionized calcium (iCa2+) and chlorides (CI-) on the EC 90 analyzer. Intended for screening, monitoring
and diagnosis of diseases associated with ionic imbalance as kidney disease, disorders of acid-base
balance, nutritional disorders and digestive tract function. For professional use in clinical laboratory
only.

Malfunctions of the instrument may occur if it is used in any different manner than defined in
Attention! this manual. In this case, incorrect analysis results may be shown and the operator can be
harmed or injured.

Use only the accessories supplied by Erba Lachema for operating the EC 90 series. These include
Attention! e.g. the EC cartridges, EC Biosensors, quality control material, printer paper or washing unit.
Please read the instruction for use for detailed information.

EC 90 User Manual 13
 INTRODUCTION

2.2 Measurement and calibration methods

2.2.1 Measurement
The electrolyte sensors are potentiometric sensors which measure the potential difference between
an ion-selective electrode (ISE) and a reference electrode immersed in a sample liquid. The electro-
chemical potential between the sample side and the solid contact of the ion-selective membrane is
proportional to the concentration of the corresponding ion in the sample. Replace with: These poten-
tials are electronically amplified, recorded and calculated using the Nernst Equation.

2.2.2 Calibration
Calibration is performed with two aqueous solutions containing different known ion concentrations.
The use of two calibration points to calculate the measurement value as well as the constant internal
monitoring of the calibrations ensures the accuracy and precision of the measurement results. The
calibration solutions in the EC cartridges are specifically designed for this system.

Use only the EC cartridges supplied by Erba Lachema for performing calibrations on the EC 90
Attention!
series, otherwise the correctness of measurement values cannot be guaranteed.

2.2.3 Measurement evaluation

Before making a medical decision based on the measured electrolyte values, the test results
Attention! must be carefully examined by a health professional who will take the patient's clinical
condition into consideration.

The instrument supports quality control (QC) functions. QC tests can be performed on different levels.
For normal and high levels the QC materials ERBA NORM and ERBA PATH can be purchased from Erba
Lachema. It is recommended to perform QC measurements according to your local laboratory
guidelines.

For further information on QC measurements, please refer to chapter 4 Operation and read
Read
the section Quality Control on page 62.

EC 90 User Manual 14
 INTRODUCTION

2.3 Scope of supply

The standard scope of supply includes the following components:
Table 1

Qty System component Details

1x Instrument EC 90 Electrolyte Analyser
with European/Russian plug
3x Power cord with Indian plug
with Brazilian plug
1x USB flash drive incl. latest instrument software and user manual
incl. relevant steps needed for installation and performing
1x Quick start guide
measurements, QC and calibrations
1x Printer paper Thermal paper roll
1x Washing unit incl. biosensor dummy, EC cartridge connector and tubing
1x Accessory box Content can be taken from the list included in the box

Please check the package contents for completeness and signs of visible damage immediately
Attention! after delivery/unpacking. If the consignment is incomplete or contains damaged parts, the
device should not be used. In this case, please contact your dealer or local distributor.

The following accessories may be purchased independently:

Table 2

Accessories Details Product code

Type M REG00056
Type L REG00057
EC cartridge
Type S REG00058
Type XS REG00065
Type M REG00062
Type L REG00063
EC cartridge plus iCa
Type S REG00061
Type XS REG00066
EC Biosensor needs to be inserted to the upper part of EC cartridge REG00064
ERBA NORM – 4x5 pack BLT00080
ERBA NORM – 10x5 pack XSYS0123
Quality control material ERBA PATH – 4x5 pack BLT00081
ERBA PATH – 10x5 pack XSYS0124
MISSION CONTROL LEVEL 1-2-3 DD-92123

EC 90 User Manual 15
 INTRODUCTION

incl. most used parts for maintenance and replacement

Maintenance kit such as valve tubes, pump tube, needle block, fittings, 10020754
springs etc.
EC urine diluent Diluent solution for urine samples REG00059
Printer paper Thermal paper rolls 51000230

2.4 Description of the instrument and accessories

2.4.1 Instrument
Front view

Figure 1

EC 90 User Manual 16
 INTRODUCTION

Front door open

Figure 2
Sample cover open (sample aspiration unit)

Figure 3

EC 90 User Manual 17
 INTRODUCTION

Back view

Figure 4
Left view

Figure 5

For information about the fluidic system of the instrument, please refer to chapter 5 Maintenance
Read
and read the section Fluidic schematic starting on page 90.

EC 90 User Manual 18
 INTRODUCTION

2.4.2 EC cartridge

The EC cartridge assembly consists of the reagents, EC Biosensor and cartridge connector. This
Hint
single-unit consumable enables easy and efficient handling.

Leakage protection components

Figure 6

Connector unit

Figure 7

EC 90 User Manual 19
 INTRODUCTION

2.5 Specifications

2.5.1 General specifications of the instrument and accessories

Table 3

Product data
Voltage range 100 – 240 VAC
Electrical data Frequency 50/60 Hz
Power consumption 60 W
Protection class Class B
Classification Overvoltage category II
Pollution degree 2
Width 268 mm
Instrument Height 334 mm
Depth 425 mm
Dimensions
Width 98 mm
EC cartridge Height 154 mm
Depth 202 mm
Instrument 7.1 kg
Weight
EC cartridge 1.2 kg
Seiko thermal line printer
Type
LTP01-245-12
Resolution W 8 dots/mm × H 16 dots/mm
Printer
Printing speed 25 mm/s
Paper width 58 mm
Paper Length Max. OD 60 mm roll
Type TFT-LCD, CAP T/P
Touch Screen Format 8.4 inch
Resolution 600 x 800 pixels

EC 90 User Manual 20
 INTRODUCTION

2.5.2 Environmental parameters

Table 4

Temperature/ Humidity / Stability

Ambient temperature 15°C to 35°C
Operating Relative humidity 15 % to 90 %
conditions Altitude < 2000 m
Instrument
Location Indoor use only
Storage and Temperature 2°C to 35°C
transport Humidity 15 % to 90 %
Ambient temperature 15°C to 35°C
Operating
Relative humidity 15 % to 90 %
conditions
Altitude < 2000 m
Temperature 2°C to 30°C
EC cartridge Humidity 15 % to 90 %
Storage
18 months from date of
Shelf life
manufacture
Temperature 2°C to 30°C
Transport
Humidity 15 % to 90 %

2.5.3 Measured parameters

Table 5

Measuring range Precision Precision Resolution

Specified for
[mmol/L] within run between runs [mmol/L]
Whole blood
Serum/Plasma 100 – 200  1 % CV  2 % CV
Na+ 0.1
Aqueous
Diluted urine (1:3) 25 – 400  5 % CV  5 % CV
Whole blood
Serum/Plasma 1 – 15  1 % CV  2.5 % CV
K+ 0.01
Aqueous
Diluted urine (1:3) 10 – 180  5 % CV  5 % CV
Whole blood
2+
 0.02 SD in  0.03 SD in
iCa Serum/Plasma 0.1 – 2.5 0.01
mmol/l mmol/l
Aqueous
Whole blood
Serum/Plasma 50 – 170  1 % CV  2.5 % CV
Cl- 0.1
Aqueous
Diluted urine (1:3) 40 – 400  5 % CV  5 % CV
1) Please note that iCa2+ can only be measured with the EC cartridge plus.

EC 90 User Manual 21
 INTRODUCTION

2.5.4 Sample parameters

Table 6

Measurement data
Whole blood
Serum/Plasma
Types
Aqueous
Diluted urine (1: 3)
90 µl (standard)
Required volumes 35 µl
200 µl (diluted urine – 1:3)
Throughput 90 samples/h
Typical time to display 35 s

2.5.5 Materials and supplies

Table 7

Supply specifications
Sample containers Tubes spray-coated with sodium heparin as anticoagulant
Urine diluent EC urine diluent
acryl-des®
- based on quaternary ammonium compounds
- registered trademark of Schülke & Mayr GmbH
Recommended surface Meliseptol®
disinfectants - based on alcohol
- registered trademark of B. Braun Medical AG
1-3 % NaClO solution
- based on chlorine

EC 90 User Manual 22
 USER INTERFACE GUIDE

3 User interface guide

3.1 General information
This chapter provides basic information about the design of the EC 90 series graphical user interface
(UI). This should help the user to facilitate the operation of the instrument. Be aware that the manual
shows only an exemplary product of the series, therefore the illustrations may differ from those on
your device.

Hint It is recommended to read this chapter before initial operation of the instrument!

3.2 Levels of access

The instrument can be operated by users with different access rights. In general, three different user
levels are implemented in the software: User, Admin and Service. The following table provides a brief
overview of individual permissions for User and Admin levels of access. As the Service user level is only
assigned to service technichians, it is not further discussed in this manual.
Table 8

User level Short description of access rights and permissions

• Perform sample/QC measurements and calibration
• View & evaluate the corresponding results
User
• Perform maintenance routines
• Configure basic system settings
Extended User permissions which enable to
• Perform software updates
Admin • Configure user accounts
• Configure critical settings
(Operation and QC settings)
Service Special access rights for service technicians which are not granted to end users

For detailed information on User and Admin access rights and how to assign them to user accounts,
Read please refer to chapter 6 Setup and read the section
Users starting on page 159.

EC 90 User Manual 23
 USER INTERFACE GUIDE

3.3 Keyboard
The instrument is entirely operated via touchscreen. Tapping in any text field will display the on-screen
keyboard. Type the desired text and press ENTER to store the text or value on the instrument. Click
the X button to close the keyboard.

Figure 8

Figure 9

If required, a mouse, keyboard or barcode reader can be connected to the instrument via USB. It is not
possible to use a USB receiver for the use of a unifying mouse or keyboard.

EC 90 User Manual 24
 USER INTERFACE GUIDE

3.4 Barcode reader

For certain inputs it is possible to read the data with a barcode reader. The barcode reader is connected
to the instrument via USB. To read in data, press the corresponding input field or, if available, the
barcode button.

Figure 10

The keyboard will appear, but no input is necessary. To cancel the scanning, press the X button on the
keyboard.

The following barcode readers are approved for the EC90:

• GRYPHON GD4130-WH
• GRYPHON D432
• Symbol LS2208

• Zebra (Motorola) LS2208

For testing a barcode reader follow the steps below:

1. Go to the Quality Control menu by pressing the corresponding button in the top bar.
2. Switch from QC results to QC materials by pressing MATERIAL.
3. Press the add new QC material button.

4. Press the barcode button next to QC lot.

EC 90 User Manual 25
 USER INTERFACE GUIDE

Figure 11

5. Scan the barcode below. If “Erba-EC90” is automatically filled in, the barcode reader is com-
patible.

Figure 12

6. Press cancel.

EC 90 User Manual 26
 USER INTERFACE GUIDE

3.5 Button design

3.5.1 Regular screen buttons

Text label and icon buttons are the core components of the user interface. By pressing them, the
assigned actions are executed. Their colors contain information about the button status or access
rights which are required to perform the assigned actions.
Table 9

Design Description/use Access rights

Default or active status User

Selected or inactive status User

Attention or warning Admin

Information Service

3.5.2 Workflow status buttons

The status buttons are implemented in pop-ups displaying operation or maintenance workflows only.
These workflows compose of a series of sequential tasks which must be completed by the operator.
The button gives information on the level of user interaction required to complete the current task.
Upon confirmation of successful completion, the button will change to the checked state and can no
longer be pressed.
Table 10

Design Description/use
This step requires user interaction. In order to proceed, the operator must
confirm successful completion of the task by pressing the status button.

This step requires user interaction. The system will automatically detect
successful task completion and proceed with the next step.

This step or procedure has been successfully completed.

EC 90 User Manual 27
 USER INTERFACE GUIDE

3.5.3 Selection buttons

Selection label and icon buttons are implemented in specific pop-ups as well as the setup submenus.
Individual settings and features may be activated or deactivated by pressing the provided buttons.
Table 11

Design Description/use

This setting is deselected.

This setting is selected.

3.6 Top bar

The top bar is visible in every screen of the UI, with exception to the login screen and when the
instrument is running in the economy mode. It enables easy navigation and access to the the individual
menus of the instrument.

Figure 13

3.7 Bottom bar

The bottom bar is visible in all screens of the UI, with exception to the login and economy mode screen.
It provides the user with important information about the system.

Figure 14

EC 90 User Manual 28
 USER INTERFACE GUIDE

3.7.1 System status

The system status icons and descriptions inform the operator on the current status of the instrument.
Depending on which action the instrument is currently performing, the icon colors and descriptions
change automatically.
Table 12

Icon and instrument status Description/use

The instrument is ready for operation.

The instrument is not ready for operation due to ongoing or

pending maintenance and set-up procedures.
The instrument is busy operating or due to ongoing start-up,
shutdown or maintenance procedures

3.7.2 System notice

The system notices inform the operator about important upcoming procedures and pending tasks.
Table 13

Notice Description/use
Announces the time of next automatic calibration which will be
performed according to the set intervals.

The installed cartridge has exceeded its specified service life.

Informs the operator about due periodic maintenance tasks.

The pump could not be sucessfully calibrated during the last 2P

calibration.
Initial aspiration of reference and calibration solutions was
unsuccessful.
There is not enough memory available for operation. Back up
and delete data to to clear the memory.
There is not enough memory available for operation. Back up
and delete QC data to to clear the memory.

EC 90 User Manual 29
 OPERATION

4 Operation
4.1 Start-up

Carefully follow these steps in a sequential order to avoid any failures and malfunctions during
Attention!
initial operation of the instrument.

4.1.1 Installation and incoming inspection

Make sure to select a suitable and secure location for installing the instrument. Do not relocate the
device after start up. Place the instrument on a flat, level surface which is not subject to direct sunlight.
If the instrument has been stored in a cold room or was transported at low temperatures, be aware
that condensate may have formed which could cause failure of the instrument. Wait for the
instrument to equilibrate to room temperature for at least one hour before initial operation.

The following conditions must be met for correct installation:

• Ambient temperature: + 15 °C to + 35 °C
• Avoid direct sunlight, vibrations and strong electromagnetic fields (electric transformers, X-ray
equipment, mobile phones...).
• Place on a stable, flat work surface.
• Relative humidity: 15 % to 90 %
• Allow sufficient free space around the instrument for air circulation and electrical connections
(power cord,…)
• Ensure correct mains voltage: 100 to 240 VAC

After the instrument has been set up at a location that meets the required conditions, execute the
following steps to ensure the instrument is ready for operation:

1. Check that the instrument and all required accessories are present by comparing the package
contents with the scope of supply. If anything is missing, please inform your dealer or local
distributor immediately.

Read The Scope of supply can be found on page 15.

2. Inspect the instrument and accessories for any signs of damage. If damage is noted, the
instrument should not be used. Please inform your dealer or local distributor immediately.

EC 90 User Manual 30
 MAINTENACE

4.1.2 Tube engagement and clip removal

7. Engage the peristaltic pump tube according to the following procedure:
a) Open the maintenance door.

Figure 15

b) Remove the protective foam block.

Figure 16

EC 90 User Manual 31
 MAINTENACE

c) Rotate the lever of the peristaltic pump to the upper position to clamp the tube.

Figure 17

8. Engage the valve tubing according to the following procedure:

a) Remove the tube clips by pulling them from the respective valve heads V1, V2 and V3.

Figure 18

EC 90 User Manual 32
 MAINTENACE

b) Valve tube 5 can be accessed via the left side panel of the instrument. Unscrew and
remove the the back screws (A) and remove the panel (B).

Figure 19

c) Pull off the tube clip from valve head V5.

Figure 20

d) Reinstall the left side panel and close the maintenance door.

Store the tube clips and foam block away in a safe place. They must be reinstalled to keep the
Hint
instrument safe during transportation or long-term storage of the instrument.

EC 90 User Manual 33
 MAINTENACE

4.1.3 Connecting the instrument to main power

1. Connect and plug in the power cord.
2. Turn on the instrument by flipping the toggle switch to the ON position.

Figure 21

EC 90 User Manual 34
 MAINTENACE

4.1.4 Guided start-up

As soon as the instrument has finished booting up, the login screen is displayed. The user interface (UI)
will automatically guide the operator through the start-up procedure:

1. Select the operator’s name from the drop-down list and enter the password. Press LOGIN to
continue.

Figure 22

For initial start-up, the following dummy user is provided for login:
Hint • Operator: UserOne
• Passwort: 12345

Read The UserOne has Admin level. For further information on users and access rights please read
chapter Setup and read section Users on page 159.

EC 90 User Manual 35
 MAINTENACE

2. The PUT INTO OPERATION setup pop-up window opens. From this window the operator must
set the current date and time and select the desired interface language. Press SAVE to con-
tinue.

Figure 23

3. The PUT INTO OPERATION routine is initiated automatically. Follow the on-screen instructions
until completion.

Figure 24

a) Confirm successful tube engagement and clip removal by pressing the corresponding
status button.

Figure 25

EC 90 User Manual 36
 MAINTENACE

4. Insert a new EC cartridge according to the following procedure:

a) Open the front door of the instrument (A) and lift the lever arm up (B).

Figure 26

b) Remove the cap (A), cap sealing (B) from the EC cartridge and insert the EC Biosensor (C).

Figure 27

EC 90 User Manual 37
 MAINTENACE

c) Insert the EC cartridge until stop.

Figure 28

d) Carefully close the lever arm (A). As the correct insertion of the cartridge is essential for
successfully establishing the fluidic and electrical connection, a built-in security feature will
assist the operator (B).

Figure 29

EC 90 User Manual 38
 MAINTENACE

e) If the cartridge has been correctly inserted, the front door can be closed.

Figure 30

f) Confirm successful cartridge insertion by pressing the corresponding status button.

Figure 31

5. The PRIME UP and CALIBRATION procedures are initiated automatically. The status is displayed
in the progress bar. During prime-up, the initial aspiration of the reference and calibration
solutions is performed and verified.

Figure 32

6. If a new EC cartridge is inserted the WETTING will start automatically. For wetting plasma,
serum or blood can be used. Follow the on-screen instructions until completion. It is required
to perform 10 wetting cycles. The status is displayed in the progress bar.

EC 90 User Manual 39
 MAINTENACE

Figure 33

7. This procedure is followed by an automatic 2-point calibration. Once the procedures have
been completed the window will close automatically, and the main screen is presented. All
parameters will be ready for measurement.

For detailed information on the purpose of calibration, please refer to chapter 4 Operation and
Read
read the section Calibration concept on page 77.

4.1.5 Inserting printer paper (optional)

1. Open the printer flap.

Figure 34

2. Insert the printer paper roll. Make sure that the end of the rolls feeds up from the bottom and
not the top.

EC 90 User Manual 40
 MAINTENACE

Figure 35

3. Close the printer flap and make sure that the paper is properly positioned between the flap
and instrument housing.

Figure 36

The heat-sensitive coating of the printer paper is only single-sided. It must therfore be ensured
Hint
that the paper roll is inserted correctly.

4.2 Economy mode

Over weekends and for short-term periods during which the instrument is not used, the system should
be run in the economy (eco) mode. This mode supports to save reagents and protects the instrument
from clotting and crystallisation of liquid reagents.

4.2.1 Interval settings

By default, the instument will switch to the eco mode after 4 hours of inactivity.
Hint
The interval settings can be changed by Admin level users.

Read For information on how to adjust the interval settings, please refer to chapter 6 Setup and read
the section Operation settings on page 149.

EC 90 User Manual 41
 MAINTENACE

4.2.2 Manual activation

1. Go to the main menu.

Figure 37

2. Press the standby icon button on the main screen.

Figure 38

EC 90 User Manual 42
 MAINTENACE

4.2.3 System reinitialization

The economy mode is indicated by a dim screen with a single icon.
To reinitialise the system, press the power on icon in the lower right corner. Depending on the duration
of the eco mode, a 1- or 2-point calibration is performed. Afterwards, the instrument will be ready for
operation.

Figure 39

EC 90 User Manual 43
 MAINTENACE

4.3 Measurement

4.3.1 Main menu overview

The main screen provides the operator with all basic information and functions required for
performing sample measurements. Additionally, it accomodates icons for device status, USB export,
activation of economy mode and user logout.

Figure 40

For information on how to perform a data backup, please refer to chapter 4 Operation and read
Read
section Exporting and deleting data on page 59.

EC 90 User Manual 44
 MAINTENACE

4.3.1.1 Device status button

By pressing the device status button, the system status information is shown in a pop-up window.
The pop-up shows if the device is not usable (system lock), when there is information regarding the
EC cartridge (e.g. expired) or the sensor cartridge (e.g. no valid slopes) or when maintenance is
pending (e.g. needle block). Pressing the info icon on the right side will show an additional pop-up
with detailed information. If no system related information is available the button is grayed out.

Figure 41

4.3.1.2 EC cartridge status

EC cartridges supply the instrument for a limited number of measurements during their service life.
The main screen automatically displays the number of remaining tests which can be performed with
the currently installed cartridge. Additionally, it keeps track of how many days the cartridge has been
in use. As soon as the fill level or service life reach certain threshold values, the status field and
speedometer color will change from green to orange and from orange to red.
Table 14

EC cartridge status Reagent fill level Remaning service life

≥ 10 % ≥ 9 days

9-5% 8 - 4 days

≤4% ≤ 3 days

EC 90 User Manual 45
 MAINTENACE

4.3.1.3 Parameter status

The button colors and warnings inform the operator about the status of the parameters. Calibrated
parameters may be selected/deselected for measurements as desired. Uncalibrated parameters are
automatically locked and specified as “not calibrated”. They are not available for measurement. By
default, out-of-control parameters are active and no warning is triggered.
Table 15

Design Description/use Possible warnings

Parameter active
QC not OK
(ready for measurement)

Parameter deselected
deactivated
(press to activate)

QC not OK
Parameter locked
not calibrated
(not ready for measurement)
PUMP CAL NOT OK (system notice)

Parameter locked
Slope out of range
(not ready for measurement)

Hint The level of strictness (warning/locking) for out-of-control QC measurements can be set by Admin
level users.

For detailed information, please refer to chapter 6 Setup and read the section QC settings on page
Read
163.

4.3.1.4 Smart calibration

As soon as single/multiple parameters are locked because the are “not calibrated”, the CAL FOR READY
button is active. Pressing the button will initiate a smart calibration. This implies that the system first
evaluates the current status of the instrument and then performs either a 1-point or 2-point calibration
as required. Afterwards, all parameters are ready for measurement.

EC 90 User Manual 46
 MAINTENACE

Figure 42

4.3.2 Performing measurements

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

4.3.2.1 Single measurement

1. Start a measurement by pressing the corresponding button on the main screen.

Figure 43

2. The MEASURE selection pop-up window opens.

Figure 44

EC 90 User Manual 47
 MAINTENACE

Figure 45

EC 90 User Manual 48
 MAINTENACE

a) Select the sample type from the first drop-down list. The following sample types are
available for measurement:
• Blood
• Plasma/Serum
• Aqueous
• Urine

Urine samples are measured according to a specific procedure which requires two sample
Hint
aspirations.

Standard mode
In the standard mode the measurement is performed directly after aspiration of the sample.

Measure Urine
Urine samples are measured according to a specific procedure which requires two sample
aspirations. During first aspiration the tubing and sensors are pre-rinsed with sample
(V  110 µl). This is done to prevent a carry over caused by the calibration solution. The actual
measurement is performed after second sample aspiration (V  90 µl). Hence, this mode
requires a larger sample volume (V  200 µl) per measurement.

b) Select the sample volume from the second drop-down list. The following sample volumes
are available for measurement:
• 35 µl
• 90 µl

Hint By default, measurements are performed in the standard mode with 90 µl of sample.

c) To assure proper sample and patient identification select the PATIENT drop down button
and enter all information required:
• Sample ID (maximum 22 characters)
• Patient ID (maximum 22 characters)
• Last/first name
• Birth Date
• Age

It is recommended to provide this information for each measurement to ensure tracebility of the
Hint
results. However, these fields are not mandatory.

EC 90 User Manual 49
 MAINTENACE

Hint The age will be filled in automatically as soon as a birth date has been selected. Therefore, the
calendar entry must be deleted before entering a different age.

d) Press START to continue.

3. The MEASURE routine is initiated. Follow the on-screen instructions to perform the
measurement:

Figure 46

a) Lift the sample cover (A) and pass the sample to the needle (B).

Figure 47

EC 90 User Manual 50
 MAINTENACE

b) The sample will be automatically aspirated when the proximity sensor is triggered. To
trigger aspiration, approach the sensor with an outstretched finger and remain within its
proximity for at least 1 second.

Figure 48

c) Alternatively, press the corresponding button to manually start the sample aspiration.

Figure 49

Automatic aspiration with the help of the proximity sensor can be enabled/disabled by Admin level
Hint
users.

For information on how to enable and configure the proximity sensor, please refer to chapter 6
Read
Setup and read the section System on page 155.

d) A sound notification will chime when aspiration has been completed.

e) Retract the sample container from the needle and close the sample cover.
e) Now the measurement is performed. After it has been completed, the MEASURE window
will close.

Figure 50

EC 90 User Manual 51
 MAINTENACE

4. The measured values are displayed in a pop-up window. The window closes automatically after
5 seconds.
5. The results menu opens automatically (see Figure 52). If you want to measure a new sample,
press the provided measurement button. You will be directly forwarded to the MEASURE
selection pop-up window (see Figure 44) without having to go back to the main screen.

Figure 51

4.3.2.2 Serial measurement

In case you want to run multiple tests on a single patient sample, there is the possibility to peform
serial measurements. After the first measurement is completed simply lift the sample cover instead of
pressing the measurement button (see Figure 51). This will immediately initiate the MEASURE routine
without opening the selection pop-up window (see Figure 46).

Sample identification is provided by the sample ID counter which is activated and automatically
Hint incremented after each serial measurement. This value is displayed next to the sample ID in the
results table.

EC 90 User Manual 52
 MAINTENACE

4.4 Results

4.4.1 Results menu overview

Hint The results menu it is automatically displayed upon completion of a sample measurement.

The results screen provides access to all test results. It contains functions for scanning through the
records as well as for printing, filtering and exporting data. Additionally, it accomodates a
measurement button which enables the operator to directly start a new measurement.

Figure 52

4.4.1.1 Results table

The test results are listed in chronological order of measurement. Each record provides quick access
to essential information such as the measured electrolyte levels or sample ID and test number. The
test number value is a useful feature which facilitates sample identification. This counter is
automatically incremented after each measurement. For serial measurements, the sample ID is also
supplemented by a counter. This number indicates how many serial measurements have been
performed (for example, bl_1_3 #03). Use the horizontal scroll bar to display further details such as
the operator, sample type or patient information. By pressing the vertical arrow buttons the entire
results table may be scanned. Individual results can be selected for printing or displaying error
information by tipping on the respective record.

EC 90 User Manual 53
 MAINTENACE

4.4.1.2 Electrolyte levels

By default, the electrolyte concentrations are expressed in mmol/l and deviations from the
Hint
reference values are displayed. These settings may be changed by Admin level users.

Each record displays the determined electrolyte concentrations in the sample. Single arrows next to
measured values indicate whether the concentrations are above or below the physiological range. The
applicable range varies with the age of the patient. If desired, this display function can also be disabled.

Figure 53

Read For information on how to adjust the displayed parameter units and reference value settings,
please refer to chapter 6 Setup and read the section Operation settings on page 149.

4.4.1.3 Error flags

Error (E) and message (M) codes inform the operator about errors and other events which may occur
during measurement. They replace the affected parameter values and are shown in red to make them
easily noticeable. In case of process errors which affect all parameters, an icon appears in the error
flag column and measurement values are not determined.

Figure 54

Read For information on error/message codes and their meanings, please refer to chapter 7
Troubleshooting and read the section Events related to parameters on page 176.

EC 90 User Manual 54
 MAINTENACE

For process errors the operator can directly retrieve details about the occurrence of the event.
6. Select the measurement by tipping on the respective record.
7. Press the event info icon.

Figure 55

8. An information pop-up window opens. The provided description gives a brief overview of the
detected errors and other events. Pressing the info icon on the right side will show an
additional pop-up with detailed information.

Figure 56

Read For further information on process errors and how to resolve them, please refer to chapter 7
Troubleshooting and read the section Events related to analyser processes on page 172.

EC 90 User Manual 55
 MAINTENACE

4.4.2 Printing data

Automatic printing of sample measurement and QC results can be enabled/disabled by operators

Hint
with User level access. Individual records or filtered data may also be printed out manually.

1. To manually print out data, press the print icon in the respective screen.

Figure 57

2. The PRINT pop-up window opens. Depending on the screen and previous actions of the
operator, different buttons will be active.

Figure 58

a) Press SELECTED to print the selected data record.

This button is only active if an individual record has been previously selected.
b) Press FILTERED DATA to print the list of filtered data records.
This button is only active if a filter has been previously applied.

Hint If the pop-up window is closed during ongoig printing, the printing process will be canceled.

For information on how to adjust the printer settings please refer to chapter 6 Setup and read the
Read
section Printer on page 152.

EC 90 User Manual 56
 MAINTENACE

4.4.3 Filtering data

Filtering can be used to search for and display specific results and records. Apply a filter in order
Hint
to print out particular records of a dataset.

1. Press the filter icon in the respective screen.

Figure 59

2. A pop-up window will appear.

Figure 60

a) Enter or select the desired filter criteria. Depending on the dataset, the records can be
filtered by various elements such as
• Date
• Test #
• Error flag
• etc.
b) Press APPLY to confirm your selection.

EC 90 User Manual 57
 MAINTENACE

3. The respective data table will display the list of filtered records (see Figure 61 as example).

Figure 61

4. Press the active filter icon to remove the filter and show all records.

Figure 62

EC 90 User Manual 58
 MAINTENACE

4.4.4 Exporting and deleting data

The entire dataset can be saved by exporting them to a USB flash drive. Afterwards, the operator
Hint can free up memory space by deleting this data from the instrument. It is recommended to back
up important data before performing a full system shutdown.

Hint Only use USB sticks with FAT or FAT32 formatting. Other formats might not work on the
instrument.

1. Go to the respective screen from which you want to export data.

2. Press the export icon in the respective screen.

Figure 63

3. The REPORT pop-up window opens. Follow the on-screen instructions to export the respective
records to a USB flash drive and optionally delete the data from the system:

Figure 64

a) Insert the USB flash drive.

b) Wait for data transmission to be completed. The status is displayed in the progress bar.

Figure 65

EC 90 User Manual 59
 MAINTENACE

c) To free up memory space, confirm to delete the exported data by pressing DELETE.

Figure 66

d) Wait until deletion is completed.

e) Remove the USB flash drive. Afterwards, the REPORT window will close automatically.

Figure 67

Deleting data

1. press the delete icon in the perspective screen.

Figure 68

2. The DELETE pop-up window opens. Depending on the screen and previous actions of the
operator, different buttons will be active.

Figure 69

a) Press SELECTED to delete the selected data recors.

This button is only active if an individual record has been previously selected.

EC 90 User Manual 60
 MAINTENACE

b) Press FILTERED DATA to delete the list of filtered data records.

This button is only active if a filter has been previously applied.

4.4.5 Exporting data via LIS

1. Go to the respective screen from which you want to export data.

2. Press the LIS export icon in the respective screen.

Figure 70

3. The LIS pop-up window opens. Depending on the screen and previous actions of the operator,
different buttons will be active.

Figure 71

a) Press SELECTED to export the selected data records.

This button is only active if an individual record has been previously selected.
b) Press FILTERED DATA to export the list of filtered data records.
This button is only active if a filter has been previously applied.

EC 90 User Manual 61
 MAINTENACE

4.5 Quality Control

4.5.1 QC concept
Quality control (QC) is an important tool for analytical laboratories to ensure the high quality of the
results. It verifies the ability of the instrument to perform accurate and precise measurements. The EC
90 series supports manual QC testing. The measurement performance of the instrument can be
verified using different levels.

Attention! It is recommended to perform QC measurements according to your local laboratory guidelines.

The following QC materials can be purchased from Erba Lachema:

• ERBA NORM for normal levels
• ERBA PATH for high levels (pathological range)

It is recommended to only use the QC material supplied by Erba Lachema for performing QC
measurements on the EC 90 series. If alternative QC material is used, be aware that the
Attention! operator must take the responsibility to determine and add mean target values and standard
deviations to the specific material. Be careful to choose the correct matrix (aqueous,
plasma/serum or urine) when adding an alternative control solution.

Read The list of available accessories can be found in the section Scope of supply on page 15.

Information on how to prepare the QC material for the measurements should be taken from the
enclosed package inserts. The lot number of a control solution can be found on the label of each vial
or the package inserts. The latter also contains the target values and standard deviation for each
electrolyte parameter.

EC 90 User Manual 62
 MAINTENACE

4.5.2 QC menu overview

The QC menu provides the operator with functions for performing QC measurements and viewing the
corresponding results as well as for managing the QC material database. The operator can switch
between two different screens by pressing the corresponding buttons (see Figure 72). The results
screen contains the QC results and the material screens provides access to the QC material database.
Measurements can be initiated from the results screen by pressing the provided button.

Figure 72

Hint The default view of the QC menu is set to the results screen.

EC 90 User Manual 63
 MAINTENACE

4.5.3 QC materials
4.5.3.1 Material screen overview
The QC material database provides access to all registered control solutions. It enables the operator
to add new or delete obsolete control lots as well as to modify existing material records. The database
can be accessed from the QC menu. Press the corresponding button to switch to the material screen.

Figure 73

Hint The default view of the QC menu is set to the results screen.

Figure 74

4.5.3.1.1 Material table

The QC materials are listed in order of the lot number. Each record provides quick access to essential
information such as the level, expiry date or control solution type. Use the horizontal scroll bar to
display the target values and standard deviations for each electrolyte parameter. By pressing the
vertical arrow buttons the entire material table may be scanned. Individual lots can be selected for
modification or deletion by tipping on the respective record.

EC 90 User Manual 64
 MAINTENACE

4.5.3.1.2 Adding control solutions

Before the measurement, the QC material must be registered in the database. Information on the
Hint
QC material can be taken from the vial labels and package inserts.

1. To add a new lot, press the respective button provided on the QC material screen.

Figure 75

2. The ADD pop-up window opens. Enter all information about the control solution or press the
barcode button to scan the barcode on the QC material to automatically insert the data.

Figure 76

Press SAVE to complete the registration and close the pop-up window.

Figure 77

For information on barcode reader, please refer to chapter 3 User interface guide and read section
Read
Barcode reader on page 25.

EC 90 User Manual 65
 MAINTENACE

4.5.3.1.3 Modifying control solutions

This function enables the operator to correct values and other information for previously added
control materials. If any data entered in Figure 77 is incorrect, this can be modified after completing
registration.

1. Select the material by tipping on the respective record.

2. Press the matching button provided on the QC material screen.

Figure 78

3. The MODIFY pop-up window opens. Edit the existing material data as desired or press the
barcode button to scan the barcode on the QC material to automatically insert the data.

Figure 79

Press SAVE to save all changes and close the pop-up window.

Figure 80

For information on barcode reader, please refer to chapter 3 User interface guide and read section
Read
Barcode reader on page 25.

EC 90 User Manual 66
 MAINTENACE

4.5.3.1.4 Deleting control solutions

This function should only be used in rare cases, for example if there is not enough storage space to add
a new QC material.

Attention! Be aware that all data related to the control material will also be deleted!

1. Select the material by tipping on the respective record.

2. Press the matching button provided on the QC material screen.

Figure 81

3. Confirm that you want to delete the control solution and all related measurement data by
pressing DELETE.

Figure 82

For information on how to perform a data backup, please refer to chapter 4 Operation and read
Read
section Exporting and deleting data on page 59.

EC 90 User Manual 67
 MAINTENACE

4.5.4 Performing QC

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

1. Start a QC measurement by pressing the corresponding button on the QC menu results screen.

Figure 83

2. The MEASURE QC selection pop-up window opens.

Figure 84

a) Select the level of the previously registered control solution from the first drop-down list.
b) Select the lot number of the previously registered control solution from the second drop-
down list. Before starting the measurement, verify if the entered lot number matches that
on the vial label.
c) Press START to continue.
3. The MEASURE QC routine is initiated. Follow the on-screen instructions to perform the
measurement:

Figure 85

EC 90 User Manual 68
 MAINTENACE

a) Lift the sample cover and pass the QC vial to the needle.

Figure 86

b) The control solution will be automatically aspirated when the proximity sensor is triggered.
To trigger aspiration, approach the sensor with an outstretched finger and remain within
its proximity for at least 1 second.

Figure 87

c) Alternatively, press the corresponding button to manually start the aspiration.

Figure 88

Automatic aspiration with the help of the proximity sensor can be enabled/disabled by Admin level
Hint
users.

EC 90 User Manual 69
 MAINTENACE

For information on how to enable and configure the proximity sensor, please refer to chapter
Read
6 Setup and read the section System on page 155.

d) A sound notification will chime when aspiration has been completed.

e) Retract the vial from the needle and close the sample cover.
f) Now the QC measurement is performed. After it has been completed, the MEASURE QC
window will automatically close.

Figure 89

g) The measured values are displayed in a pop-up window. The window closes automatically
after 5 seconds.
h) The results are listed in the QC menu results screen (see Figure 91).

EC 90 User Manual 70
 MAINTENACE

4.5.5 QC results
4.5.5.1 Results screen overview
The results screen enables the operator to perform QC measurements and provides access to all QC
results. It can be accessed from the QC menu. Press the corresponding button to switch to the results
screen.

Figure 90

The default view of the QC menu is set to the results screen. The measurement results can be
Hint
visualized as table or Levey-Jennings chart.

Figure 91

4.5.5.1.1 QC results table

The QC results for the selected level and lot number are listed in chronological order of measurement.
Each record provides quick access to essential information such as the measured electrolyte levels,
operator or QC test number. The test number is an auto-increment counter which facilitates the
tracking of measurements. Use the horizontal scroll bar to display the QC sample type. By pressing the
vertical arrow buttons the operator can scan through the entire results table for the respective lot.
Individual results can be selected for printing or displaying error information by tipping on the
respective record.

EC 90 User Manual 71
 MAINTENACE

4.5.5.1.2 QC electrolyte levels and out-of-control results

The level of strictness (warning/locking) for out-of-control QC measurements can be set by Admin
Hint
level users.

Read For detailed information, please refer to chapter 6 Setup and read the section QC settings on
page 163.

Each record displays the determined electrolyte concentrations in the control solution in mmol/l. If
out-of-control measurements are set to trigger warnings or locking of parameters, an icon appears in
the error flag column indicating that the selected Westgard rules have been violated.

Figure 92

In this case, the operator can directly retrieve details about the violated QC rules:
9. Select the measurement by tipping on the respective record.
10. Press the event info icon.

Figure 93

11. An information pop-up window opens. The provided description gives a brief overview of the
detected Westgard rule violations for the individual parameters. Pressing the info icon on the
right side will show an additional pop-up with detailed information.

Figure 94

For information on QC errors and how to resolve them, please refer to chapter 7 Troubleshooting
Read
and read the section Events related to out-of-control measurements on page 178.

EC 90 User Manual 72
 MAINTENACE

4.5.5.1.3 Levey-Jennings chart

1. Press the Levey-Jennings icon to graphically visualise the QC measurement data.

Figure 95

2. The Levey-Jennings pop-up window will display the plotted data for the selected paramter, QC
level and lot number. The red lines indicate the out-of-control limits. The statistical evaluation
provides information on the mean, standard deviation and coefficient of variation for the given
number of QC measurements.

Figure 96

3. Individual QC measurements may be excluded from the graph and statistical calculation. By
tipping on the respective data point, the operator can display detailed information about the
measurement.

Figure 97

EC 90 User Manual 73
 MAINTENACE

4. Press the REJECT button to exclude the data point from the evaluation.

Figure 98

5. Use the horizontal arrow buttons to scroll to the next QC measurement dataset.
6. To assign an individual target value to the QC material a lab mean can be calculated from at
least four measuring points:
a) Select a start point and press LAB MEAN START.

Figure 99

EC 90 User Manual 74
 MAINTENACE

b) Select an end point and press LAB MEAN END.

Figure 100

c) Press CALCULATE LAB MEAN.

Figure 101

EC 90 User Manual 75
 MAINTENACE

d) Confirm to apply the lab mean and ISD to all parameters.

Figure 102

Hint Please note that Westgard rule violations are not recalculated.

4.5.5.1.4 Data processing

Read For information on how to print, filter and export data, please refer to chapter 4 Operation Results
and read the respective sections starting on page 53.

4.5.5.1.5 Error flags

Error (E) and message (M) codes inform the operator about errors and other events which may occur
during QC measurement. They replace the affected parameter values and are shown in red to make
them easily noticeable. In case of process errors which affect all parameters, an icon appears in the
error flag column and measurement values are not determined.

Figure 103

Read For information on error/message codes and their meanings, please refer to chapter 7
Troubleshooting and read the section Events related to parameters on page 176.

EC 90 User Manual 76
 MAINTENACE

For process errors, the operator can directly retrieve details about the occurrence of the event.
1. Select the QC measurement by tipping on the respective record.
2. Press the event info icon.

Figure 104

3. An information pop-up window opens. The provided description gives a brief overview of the
detected errors and other events. Pressing the info icon on the right side will show an
additional pop-up with detailed information.

Figure 105

Read For further information on process errors and how to resolve them, please refer to chapter 7
Troubleshooting and read the section Events related to analyser processes on page 172.

4.6 Calibration

4.6.1 Calibration concept

The purpose of calibration is to assign the measured potential differences to known concentrations of
ions contained in two different aqueous calibration solutions. From these values, a calibration
database is recorded. These data are required for obtaining accurate and precise measurement results
for the analysis of biological and aqueous sample liquids.
Table 16

Solution Content
Na+ 150 mmol/l, K+ 5 mmol/l, iCa2+ 1.25 mmol/l, Cl- 103 mmol/l, buffer,
Calibration solution 1
preservative, wetting agent
Na+ 105 mmol/l, K+ 2 mmol/l, iCa2+ 2.34 mmol/l, Cl- 71.1 mmol/l, buffer,
Calibration solution 2
preservative, wetting agent
Reference solution K+ 1.2 mol/l, buffer, preservative, wetting agent

EC 90 User Manual 77
 MAINTENACE

The instrument supports two modes of calibration:

• 1-point calibration (1P CAL)

• 2-point calibration (2P CAL)

By default, 1-point and 2-point calibrations are performed at periodic intervals, but they can also be
performed manually on demand. Additionally, 1-point calibrations are initiated automatically after
every measurement. The operator also has the option to perform a smart calibration (CAL FOR READY).
In this case the system first evaluates the status of the instrument and then initiates either a 1P or 2P
CAL as required. The calibration solutions CAL1 and CAL2 are included in the EC cartridges specifically
designed for this concept.
Table 17

Parameter Upper Slope Limit Lower Slope Limit

Na+ 9.9 mV 6.3 mV
+
K 24.00 mV 17.19 mV
2+
iCa -6.77 mV -10.46 mV
Cl- -6.5 mV -9.7 mV

Use only the EC cartridges supplied by Erba Lachema for operating the EC 90 series. Otherwise
Attention!
the correctness of measurement values cannot be guaranteed.

Read The list of available accessories can be found in the section Scope of supply on page 15.

4.6.2 Calibration menu overview

The calibration menu provides the operator with functions for performing calibrations and for viewing
and managing the calibration database. The operator can switch between two different screens by
pressing the corresponding buttons (see Figure 106). The slope screen contains the results for 2-point
calibrations and the 1P screen for 1-point calibrations. Calibrations can be initiated from either screen
by pressing the provided calibration button.

EC 90 User Manual 78
 MAINTENACE

Figure 106

Hint The default view of the calibration menu is set to the slope screen.

EC 90 User Manual 79
 MAINTENACE

4.6.3 Performing calibrations

Hint 1P CAL is periodically performed every hour and 2P CAL every 12 hours.

Read For information on how to adjust the automatic calibration intervals, please refer to chapter 6
Setup and read the section Operation settings on page 149.

1. Start a calibration by pressing the corresponding button in one of the calibration menu
screens.

Figure 107

2. The CALIBRATE selection pop-up window opens.

Figure 108

a) Press 1P CAL to perform a 1-point calibration.

b) Press 2P CAL to perform a 2-point calibration.
c) Press CAL FOR READY to perform a smart calibration.
The system will evaluate the status of the instrument and perform either a 1P or 2P CAL as
required.
3. The respective CALIBRATION procedure is initiated. After it has been completed, the
CALIBRATE pop-up window will close automatically.

Figure 109

EC 90 User Manual 80
 MAINTENACE

4.6.4 Calibration results

4.6.4.1 Slope screen overview
The slope screen provides access to the results of 2-point calibrations. It can be accessed from the
calibration menu. Press the corresponding button to switch to the slope screen.

Figure 110

Hint The default view of the calibration menu is set to the slope screen.

Figure 111

4.6.4.1.1 2P CAL results table

The 2P CAL results are listed in chronological order of measurement. Each record provides quick access
to essential information such as the determined slope values or calibration type and test number. The
type indicates whether the calibration was performed manually by the operator or automatically
according to the set intervals. The cal number is an auto-increment counter which facilitates the
tracking of measurements. Use the horizontal scroll bar to display the name of the operator. By
pressing the vertical arrow buttons the entire results table may be scanned. Individual results can be
selected for printing or displaying error information by tipping on the respective record.

EC 90 User Manual 81
 MAINTENACE

4.6.4.1.2 Slope values and statistics

The results of 2-point calibrations are referred to as “slope” values. The slope is calculated from two
measured calibration voltages and is therefore expressed in mV. The calibration data may also be
visualized as line graph by pressing the statistics icon.

Figure 112

The statistics pop-up window will display a graphical representation of the calibration data according
to selection. The drop-down lists enable the operator to choose between parameters as well as 1-point
or 2-point calibration values. By tipping on the respective data point, the operator can display detailed
information about the calibration.

Figure 113

An EC cartridge change is indicated by a dashed vertical line and a EC Biosensor change is indicated
Hint
by a dotted vertical line.

4.6.4.1.3 Data processing

Read For information on how to print, filter and export data, please refer to chapter 4 Operation Results
and read the respective sections starting on page 53.

EC 90 User Manual 82
 MAINTENACE

4.6.4.1.4 Error flags

Error (E) and message (M) codes inform the operator about errors and other events which may occur
during 2-point calibration. They replace the affected slope values and are shown in red to make them
easily noticeable. In case of process errors which affect all results, an icon appears in the error flag
column and slope values are not determined.

Figure 114

Read For information on error/message codes and their meanings, please refer to chapter 7
Troubleshooting and read the section Events related to parameters on page 176.

For process errors, the operator can directly retrieve details about the occurrence of the event.
12. Select the calibration by tipping on the respective record.
13. Press the event info icon.

Figure 115

14. An information pop-up window opens. The provided description gives a brief overview of the
detected errors and other events. Pressing the info icon on the right side will show an
additional pop-up with detailed information.

Figure 116

Read For further information on process errors and how to resolve them, please refer to 7
Troubleshooting and read the section Events related to analyser processes on page 172.

EC 90 User Manual 83
 MAINTENACE

4.6.4.2 1P screen overview

The 1P screen provides access to the results of 1-point calibrations. It can be accessed from the
calibration menu. Press the corresponding button to switch to the 1P screen.

Figure 117

Hint The default view of the calibration menu is set to the slope screen.

Figure 118

4.6.4.2.1 1P CAL results table

The 1P CAL results are listed in chronological order of measurement. Each record provides quick access
to essential information such as the determined calibration voltages or calibration type and test
number. The type indicates whether the calibration was performed manually by the operator or
automatically according to the set intervals. The cal number is an auto-increment counter which
facilitates the tracking of measurements. Use the horizontal scroll bar to display the name of the
operator. By pressing the vertical arrow buttons the entire results table may be scanned. Individual
results can be selected for printing or displaying error information by tipping on the respective record.

EC 90 User Manual 84
 MAINTENACE

1P CAL is performed after each sample measurement. The periodoc calibration 1P Auto will
Hint
therefore only be performed if there was no measurement in the preceding hour.

4.6.4.2.2 Voltage values and statistics

The results of 1-point calibrations are voltage values and therefore expressed in mV. The calibration
data may also be visualized as line graph by pressing the statistics icon.

Figure 119

The statistics pop-up window will display a graphical representation of the calibration data according
to selection. The drop-down lists enable the operator to choose between parameters as well as 1-point
or 2-point calibration values.

Figure 120

An EC cartridge change is indicated by a dashed vertical line and a BioSensor change is indicated
Hint
by a dotted vertical line.

4.6.4.2.3 Data processing

Read For information on how to print, filter and export data, please refer to chapter 4 Operation Results
and read the respective sections starting on page 53.

EC 90 User Manual 85
 MAINTENACE

4.6.4.2.4 Error flags

Error (E) and message (M) codes inform the operator about errors and other events which may occur
during 1-point calibration. They replace the affected voltage values and are shown in red to make them
easily noticeable. In case of process errors which affect all parameter results, an icon appears in the
error flag column and calibration values are not determined.

Figure 121

Read For information on error/message codes and their meanings, please refer to chapter 7
Troubleshooting and read the section Events related to parameters on page 176.

For process errors, the operator can directly retrieve details about the occurrence of the event.
1. Select the calibration by tipping on the respective record.
2. Press the event info icon.

Figure 122

3. An information pop-up window opens. The provided error list gives a brief overview of the
detected errors and other events. Pressing the info icon on the right side will show an
additional pop-up with detailed information.

Figure 123

Read For further information on process errors and how to resolve them, please refer to chapter 7
Troubleshooting and read the section Events related to analyser processes on page 172.

EC 90 User Manual 86
 MAINTENACE

5 Maintenance
5.1 Maintenance menu overview
The maintenance menu provides the operator with information and functions required for perfoming
cleaning and other maintenance procedures. Additionally, it accomodates the power off icon to carry
out a full system shutdown. Depending on the user level, routines can be initiated and submenus can
be accessed by pressing the corresponding icon buttons.

Figure 124

The following table provides a short summary of the functions implemented for the different menu
buttons.
Table 18

Short description of available functions

EC
View information on batch number, expiry date and reagent supply status for the
cartridge
currently installed EC cartridge
status
View intervals and due dates for periodic maintenance tasks and directly initiate the
Schedule
corresponding UI guided maintenance routines
Cleaning Initiate the routine for cleaning the tubing or cleaning the screen
Tests Initiate instrument tests
Wetting Initiate wetting routine
Change EC Initiate the consumable change routine for removing the current and installing a new
cartridge EC cartridge
Technical View technical controls for pump, sensors and valves
Records View instrument, RFID and log data

EC 90 User Manual 87
 MAINTENACE

Shut down Initiate the shutdown routine to perform a full shutdown of the instrument

5.2 Decontamination and cleaning

Pay attention to the warning labels on the device. Components such as the aspiration needle,
fluidic connector or tubing etc. contain biological fluids, which potentially pose an infection
risk. These components must be handled with care in accordance with the safety regulations
for handling potentially infectious material.

In order to prevent direct contact with biological substances, adequate personal protective
equipment such as lab coats, protective gloves or safety glasses must be worn. Disinfection and
Attention!
cleaning procedures must be followed. Ensure that laboratory safety guidelines are followed
at all times. Risk of infection!

5.2.1 General information

The purpose of external surface decontamination is to minimize the risk of infection during use of the
instrument or replacement of device parts which have come in contact with biological samples.

The following external cleaning procedures must be performed at regular intervals according to the
instructions provided in this manual:

• Instrument surfaces
• Touch screen
• Sample aspiration unit

Internal decontamination refers to the cleaning of the tubing and is performed on demand.
Particularly, this cleaning procedure must be carried out in case the instrument will be put out of
operation for a long period of time (shutdown procedure).

For information on how to perform decontamination, please read the corresponding sections for
Read
each component.

EC 90 User Manual 88
 MAINTENACE

5.2.2 Recommended decontaminants

Use only specified liquid surface disinfectants!

When handling these liquids, ensure that the laboratory safety guidelines are followed.
Attention! Immediate action should be taken if any irritation to skin, eyes or mucous membranes occurs.

Do not use substances such as benzene or acetone. These chemicals may cause damage to
the instrument.

External decontamination

For external decontamintation, only the specified liquid disinfactants should be used. The following
disinfectants have been tested and are recommended for surface disinfection of the instrument:

• an alcohol-free rapid disinfectant based on quaternary ammonium compounds

e.g. acryl-des®
• a ready-to-use fast-acting alcoholic surface disinfectant
e.g. a Meliseptol®
• 1–3 % NaClO (sodium hypochlorite) solution
a widely used chlorine-based disinfectant

Other substances not similar to the listed materials might cause damage to the instrument surfaces.

Disinfectants must not be poured or sprayed directly onto the instrument to prevent
Attention! malfunctioning or damage of electronic components. Use disposable cloths such as soft paper
towels or gauze pads to apply the disinfectant and wipe the surfaces.

Internal decontamination

The tubing is cleaned by first rinsing the tubes with deproteiniser solution (max 1% NaOCl solution)
and subsequently with deionised water. For this purpose, a washing unit is included in the scope of
supply.

Read The Scope of supply can be found on page 15.

EC 90 User Manual 89
 MAINTENACE

5.3 Fluidic schematic

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

Figure 125

EC 90 User Manual 90
 MAINTENACE

5.4 Routine maintenance

5.4.1 Daily
5.4.1.1 Checking the EC cartridge status
EC cartridges supply the instrument for a limited number of measurements during their service life.
The main screen automatically displays the number of remaining tests which can be performed with
the currently installed cartridge. Additionally, it keeps track of how many days the cartridge has been
in use. As soon as certain threshold values are reached, the status field and speedometer color will
change from green to orange and from orange to red. This indicator should be checked on a daily basis,
to ensure that a cartridge change is performed in time.
Table 19

EC cartridge status Reagent fill level Remaning service life

≥ 10 % ≥ 9 days

9-5% 8 - 4 days

≤4% ≤ 3 days

1. Detailed information on the EC cartridge can be accessed by pressing the corresponding button
in the maintenance menu.

Figure 126

EC 90 User Manual 91
 MAINTENACE

2. The EC CARTRIDGE STATUS pop-up window displays essential information about the currently
installed EC cartridge.

Figure 127

For information on how to change the EC cartridge, please read the section Changing the EC
Read
cartridge on page 115.

5.4.1.2 Checking the printer paper

The printer paper rolls are equipped with a low paper warning mark. A red stripe on the edges
Hint indicates the end of the roll. A new paper roll should be inserted immediately, as soon as the
warning stripe appears.

Whether a paper roll exchange is required should be checked on a daily basis to ensure that enough
printer paper is available.

For information on how to replace the thermal printer paper rolls, please read the section
Read
Replacing printer paper rolls on page 136.

5.4.1.3 Cleaning the instrument surfaces

All surfaces of the instrument including sample cover, front and maintenance door as well as printer
flap must be decontaminated on a daily basis. Wipe down the instrument using disposable cloths
dampened with one of the specified disinfectants. Heavily soiled surfaces require precleaning with
swabs or cellulose wipes moistened with deionised water.

Attention!
Disinfectants must not be poured or sprayed directly onto the instrument.
Warning!

EC 90 User Manual 92
 MAINTENACE

5.4.1.4 Cleaning the touch screen

Use only disposable cloths (e.g. wipes, soft paper towels, gauze pads) dampened in suitable
Attention
disinfectant solutions. Do not use disinfectant sprays!

1. Press the corresponding button in the maintenance menu.

Figure 128

2. Select Clean Screen.

Figure 129

3. The screen will be dimmed and the CLEAN SCREEN routine is initiated.
During this routine, the touch screen is disabled for 30 seconds to allow screen disinfection.
Afterwards, the window will automatically close and the maintenance menu is shown.

Figure 130

EC 90 User Manual 93
 MAINTENACE

5.4.1.5 Cleaning the sample aspiration unit

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

1. Lift the sample cover.

Figure 131

2. Use a disposable cloth and cotton bud to apply and clean the needle (A) and needle guide (B)
with a suitable disinfectant.

Figure 132

3. Use disposable disinfectant wipes to clean the sample cover.

4. Close the sample cover.

EC 90 User Manual 94
 MAINTENACE

5.4.2 Weekly
5.4.2.1 Checking the air tube for crystallisation

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

1. Open the maintenance door.

Figure 133

2. Starting from valve 4, visually inspect the entire length of the air tube for evidence of crystal
growth.

Figure 134

3. Remove detected crystals by gently rolling and squeezing the tube between the fingers. The
next calibration routine will flush the contamination into the waste.
4. Close the maintenance door.

EC 90 User Manual 95
 MAINTENACE

5.5 Periodic maintenance

Periodic maintenance tasks consist of services and replacement of parts which must be performed
according to a pre-defined schedule.

1. To access the maintenance schedule, press the corresponding button in the maintenance
menu.

Figure 135

2. The SCHEDULE pop-up window gives an overview of all periodic maintenance tasks and their
due dates. If a task is overdue, the date will be shown in red. The routines are initiated by
pressing the respective icon buttons.

Figure 136

a) Press the pump icon to initate the REPLACE PUMP TUBE routine.
b) Press the needle block icon to initiate the REPLACE NEEDLE BLOCK routine
c) Press the valve head icon to initiate the REPLACE VALVE TUBES routine.
d) Press the service icon to initiate the SERVICE routine.

It is recommended to only use the spare parts included in the maintenance kit supplied by Erba
Attention! Lachema, as the functionality of the instrument cannot be guaranteed when other sparte parts
are installed for maintenance purposes.

Read The list of available accessories can be found in the section Scope of supply on page 15.

EC 90 User Manual 96
 MAINTENACE

5.5.1 Annually
5.5.1.1 Replacement of the peristaltic pump tube

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

1. To replace the pump tube, press the respective button provided in the maintenance submenu
SCHEDULE.

Figure 137

2. Initiate the pump tube replacement routine by pressing REPLACE.

Figure 138

3. The REPLACE PUMP TUBE pop-up window opens. Follow the on-screen instructions until
completion.

Figure 139

Attention! Do not take any action until the RINSING and EMPTYING procedures have completed!

EC 90 User Manual 97
 MAINTENACE

4. The RINSING and EMPTYING procedures are initiated automatically. The status is displayed in
the progress bar.
First, the pump tube is rinsed to remove potential contamination. Afterwards, the tube is
emptied to prevent the spilling of supernatant fluid during maintenance. Once the procedures
have been completed, the pump tube can be replaced.
5. Change the peristaltic pump tube and connectors according to the following procedure:
a) Open the maintenance door.

Figure 140

b) Rotate the lever of the peristaltic pump to the lower position (until stop) and remove the
tube by pulling it carefully from the mounting support.

Figure 141

EC 90 User Manual 98
 MAINTENACE

c) Disconnect the tube by pulling it from the tube adapters. Connect the new pump tube to
the adapters by sliding the tube over the entire olive until stop.

Figure 142

d) Insert the connected tube into the tube grips of the pump.

Figure 143

Attention! Ensure that the tube is inserted correctly according to the direction of flow.

EC 90 User Manual 99
 MAINTENACE

e) Verify the correct placement of the adapters by checking whether the markings on the
adapter match those on the mounting support (red adapter to red dot). Make sure that the
tube fits into the tube grips.

Figure 144

f) Rotate the lever back to the upper position and close the maintenance door.

Figure 145

g) Confirm successful pump tube replacement by pressing the corresponding status button.

Figure 146

EC 90 User Manual 100

 MAINTENACE

6. A CALIBRATION procedure is executed. The status is displayed in the progress bar. Once the 1-
point calibration has been completed the window will close automatically.

Figure 147

5.5.1.2 Replacement of the needle block

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

1. To replace the needle block, press the respective button provided in the maintenance sub-
menu SCHEDULE.

Figure 148

2. Initiate the needle block replacement routine by pressing REPLACE.

Figure 149

EC 90 User Manual 101

 MAINTENACE

3. The REPLACE NEEDLE BLOCK pop-up window opens.

Figure 150

4. Change the needle block according to the following procedure:

a) Lift the sample cover.

Figure 151

EC 90 User Manual 102

 MAINTENACE

b) Unfasten the needle guide by carefully turning it 90° in counterclockwise direction.

Figure 152

c) Remove the needle guide (A) and needle block (B) from the sample aspiration unit.

Figure 153

EC 90 User Manual 103

 MAINTENACE

d) Insert the new needle block and reinstall the needle guide (A). Fasten by turning it 90° in
clockwise direction (B).

Figure 154

e) Close the sample cover.

f) Confirm successful needle block replacement by pressing the corresponding status button.

Figure 155

5. A CALIBRATION procedure is executed. The status is displayed in the progress bar. Once the 1-
point calibration has been completed the window will close automatically.

Figure 156

EC 90 User Manual 104

 MAINTENACE

5.5.1.3 Replacement of the valve tubes

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

1. To replace the valve tubes, press the respective button provided in the maintenance submenu
SCHEDULE.

Figure 157

2. Initiate the valve tube replacement routine by pressing REPLACE.

Figure 158

3. The REPLACE VALVE TUBES pop-up window opens. Follow the on-screen instructions until
completion.

Figure 159

Attention! Do not take any action until the EMPTYING procedure has completed!

EC 90 User Manual 105

 MAINTENACE

4. The EMPTYING procedure is initiated automatically. The status is displayed in the progress bar.
Once the procedure has been completed, the operator can continue.
5. Remove the currently installed EC cartridge according to the following procedure:
a) Open the front door (A) and lift the lever arm up (B).

Figure 160

b) Remove the EC cartridge by pulling carefully.

Figure 161

The cartridge must be removed with caution to prevent the spilling of potentially infectious liquids.
Avoid denting or crushing the cardboard by exerting pressure on the side walls.

6. Insert the washing unit. Install a full bottle of DI water inside the EC cartridge compartment
and insert the three tubes which are tied together. Guide the single tube into an empty waste
bottle. Confirm successful insertion of the components by pressing the corresponding status

EC 90 User Manual 106

 MAINTENACE

button. The washing procedure is automatically initiated. The status is displayed in the
progress bar.

Figure 162

Figure 163

7. After WASHING has been completed, remove the water bottle from the EC cartridge
compartment and confirm the removal by pressing the corresponding status button.

Figure 164

8. The EMPTYING procedure is automatically initiated. The status is displayed in the progress bar.
Once the procedure has been completed, the operator can continue.
9. Remove the washing unit and waste bottle from the cartridge compartment and confirm the
removal by pressing the corresponding status button.

Figure 165

EC 90 User Manual 107

 MAINTENACE

10. Change the valve tubes according to the following procedure:

a) Open the maintenance door to access valve tubes 1 – 4.

Figure 166

b) Unscrew the back screws and remove the left side panel to access valve tube 5.

Figure 167

EC 90 User Manual 108

 MAINTENACE

c) Lift the the silicon valve tubing from the tube guides and valve heads V1 – V5.

Figure 168

Figure 169

d) Disconnect the valve tubes (A) from from the four-port cross (B) and/or FEP tubes (C).

Figure 170

EC 90 User Manual 109

 MAINTENACE

e) Connect the new valve tubes with the four-port cross and/or FEP tubes.
f) Insert the new valve tubes into the tube guides and respective valve heads V1 – V5. Ensure
that the tubes have been properly positioned.

Ensure that electrical wire connections are not loosened during replacement of valve tube 2.
Attention! Note that sufficient force must be applied to remove and insert the tubing into the tube guides
and valve heads.

Attention! Please note that the tubes are of different lengths. Make sure to install the correct ones. Note
the instructions in the maintenance kit.

g) Reinstall the left side panel and close the maintenance door.
h) Confirm successful valve tube replacement by pressing the corresponding status button.

Figure 171

11. Reinstall the old or insert a new cartridge according to the following procedure:
a. Remove the cap (A) and cap sealing (B) from the new EC cartridge and insert the EC
Biosensor (C) (if applicable).

Figure 172

EC 90 User Manual 110

 MAINTENACE

b. Insert the EC cartridge until stop.

Figure 173

c. Carefully close the lever arm (A). As the correct insertion of the cartrige is essential for
successfully establishing the fluidic and electrical connection, a built-in security feature will
assist the operator (B).

Figure 174

EC 90 User Manual 111

 MAINTENACE

d. If the cartridge has been correctly inserted, the front door can be closed.

Figure 175

e. Confirm successful cartridge insertion by pressing the corresponding status button.

Figure 176

12. The PRIME UP and CALIBRATION procedures are initiated automatically. The status is displayed
in the progress bar. During prime-up, the initial aspiration of the reference and calibration
solutions is performed and verified.
13. If a new EC cartridge is inserted the WETTING will start automatically. For wetting plasma,
serum or blood can be used. Follow the on-screen instructions until completion. It is required
to perform 10 wetting cycles. The status is displayed in the progress bar.

Figure 177

14. This procedure is followed by an automatic 2-point calibration. Once the procedures have
been completed the window will close automatically.

EC 90 User Manual 112

 MAINTENACE

Figure 178

5.5.2 3-year service

The 3-year service consists of the following maintenance procedures:

• Replacement of the
- peristaltic pump tube, connectors and silicon adapters
- needle block
- valve tubes

• Full decontamination of the instrument (external and internal)

- During internal decontamination (CLEANING routine), the tubing must be cleaned with
deproteiniser solution and deionised water.

• System test

For information on how to perform these tasks, please read the corresponding sections in the
Read
respective chapters.

After the 3-year service has been successfully performed, the completion must be confirmed
according to the following procedure:

EC 90 User Manual 113

 MAINTENACE

1. Press the respective button provided in the maintenance submenu SCHEDULE.

Figure 179

2. The SERVICE pop-up window opens.

3. Confirm successful performance of the 3-year service by pressing the corresponding status
button.

Figure 180

4. Confirm successful performance of the system check by pressing the corresponding status
button.

Figure 181

5. The SERVICE pop-up window will close automatically.

Figure 182

EC 90 User Manual 114

 MAINTENACE

5.6 On-demand maintenance

5.6.1 Changing the EC cartridge

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

1. Press the corresponding button in the maintenance menu.

Figure 183

2. Initiate the EC CARTRIDGE change routine by pressing the EC cartridge button.

Figure 184

3. The CHANGE EC CARTRIDGE pop-up windodw opens. Follow the on-screen instructions until
completion.

Figure 185

Attention! Do not take any action until the EMPTYING procedure has completed!

EC 90 User Manual 115

 MAINTENACE

4. The EMPTYING procedure is initiated automatically. The status is displayed in the progress bar.
Once the procedure has been completed, the EC cartridge can be changed.
5. Remove the currently installed EC cartridge according to the following procedure:
a) Open the front door (A) and lift the lever arm up (B).

Figure 186

b) Remove the EC cartridge by pulling carefully.

Figure 187

The cartridge must be removed with caution to prevent the spilling of potentially infectious liquids.
Avoid denting or crushing the cardboard by exerting pressure on the side walls.

EC 90 User Manual 116

 MAINTENACE

6. Install a new cartridge according to the following procedure:

a) Remove the cap (A) and cap sealing (B) from the new EC cartridge and insert the EC
Biosensor (C).

Figure 188

b) Insert the new EC cartridge until stop.

Figure 189

EC 90 User Manual 117

 MAINTENACE

c) Carefully close the lever arm (A). As the correct insertion of the cartrige is essential for
successfully establishing the fluidic and electrical connection, a built-in security feature will
assist the operator (B).

Figure 190

d) If the cartridge has been correctly inserted, the front door can be closed.

Figure 191

e) Confirm successful cartridge insertion by pressing the corresponding status button.

Figure 192

EC 90 User Manual 118

 MAINTENACE

7. The PRIME UP and CALIBRATION procedures are initiated automatically. The status is displayed
in the progress bar. During prime-up, the initial aspiration of the reference and calibration
solutions is performed and verified.
8. After PRIME UP the WETTING will start automatically. For wetting plasma, serum or blood can
be used. Follow the on-screen instructions until completion. It is required to perform 10
wetting cycles. The status is displayed in the progress bar.

Figure 193

9. This procedure is followed by an automatic 2-point calibration. Once the procedures have
been completed the window will close automatically.

Figure 194

EC 90 User Manual 119

 MAINTENACE

5.6.2 Changing the EC Biosensor

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

1. Press the corresponding button in the maintenance menu.

Figure 195

2. Initiate the EC CARTRIDGE change routine by pressing the BioSensor button.

Figure 196

3. The CHANGE BIOSENSOR pop-up window opens. Follow the on-screen instructions until
completion.

Figure 197

Attention! Do not take any action until the EMPTYING procedure has been completed!

EC 90 User Manual 120

 MAINTENACE

4. The EMPTYING procedure is initiated automatically. The status is displayed in the progress bar.
Once the procedure has been completed, the EC cartridge can be changed.
5. Remove the currently installed EC cartridge according to the following procedure:
a) Open the front door (A) and lift the lever arm up (B).

Figure 198

b) Remove the EC cartridge by pulling carefully.

Figure 199

The cartridge must be removed with caution to prevent the spilling of potentially infectious liquids.
Avoid denting or crushing the cardboard by exerting pressure on the side walls.

EC 90 User Manual 121

 MAINTENACE

6. Install a new EC Biosensor according to the following procedure:

a) Remove EC Biosensor by pressing the position lock and then pulling it out.

Figure 200

b) Pull the sensor completely out of the holder.

Figure 201

c) Enter the lot number from the new EC Biosensor. The lot number can be read from the
sensor packaging.

Figure 202

EC 90 User Manual 122

 MAINTENACE

Figure 203

d) Insert the the sensor until stop. There is a clicking sound when the home position is reached.

Figure 204

e) Insert the EC cartridge with the new EC Biosensor until stop.

Figure 205

EC 90 User Manual 123

 MAINTENACE

f) Carefully close the lever arm (A). As the correct insertion of the cartrige is essential for
successfully establishing the fluidic and electrical connection, a built-in security feature will
assist the operator (B).

Figure 206

g) If the cartridge has been correctly inserted, the front door can be closed.

Figure 207

h) Confirm successful cartridge insertion by pressing the corresponding status button.

Figure 208

EC 90 User Manual 124

 MAINTENACE

7. The PRIME UP and CALIBRATION procedures are initiated automatically. The status is
displayed in the progress bar. During prime-up, the initial aspiration of the reference and
calibration solutions is performed and verified.

Figure 209

8. After PRIME UP the WETTING will start automatically. For wetting plasma, serum or blood
can be used. Follow the on-screen instructions until completion. It is required to perform 10
wetting cycles. The status is displayed in the progress bar.

Figure 210

9. This procedure is followed by an automatic 2-point calibration. Once the procedures have
been completed the window will close automatically.

EC 90 User Manual 125

 MAINTENACE

5.6.2.1 Initiate wetting routine

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

1. Press the corresponding button in the maintenance menu.

Figure 211

2. For wetting plasma, serum or blood can be used. Follow the on-screen instructions until
completion. Follow the on-screen instructions until completion. It is required to perform 10
wetting cycles. The status is displayed in the progress bar.

Figure 212

3. After the wetting routine a 2-point calibration is performed automatically.

EC 90 User Manual 126

 MAINTENACE

5.6.3 Cleaning the tubing

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

1. Press the corresponding button in the maintenance menu.

Figure 213

2. Select System Clean.

Figure 214

3. Initiate the tubing cleaning routine by pressing CLEAN.

Figure 215

EC 90 User Manual 127

 MAINTENACE

4. The CLEANING pop-up window opens. Follow the on-screen instructions until completion.

Figure 216

5. The EMPTYING procedure is initiated automatically. The status is displayed in the progress bar.
Once the procedure has been completed, the system can be cleaned.
6. Remove the currently installed EC cartridge according to the following procedure:
a) Open the front door (A) and lift the lever arm up (B).

Figure 217

EC 90 User Manual 128

 MAINTENACE

b) Remove the EC cartridge by pulling carefully.

Figure 218

The cartridge must be removed with caution to prevent the spilling of potentially infectious liquids.
Avoid denting or crushing the cardboard by exerting pressure on the side walls.

7. Insert the washing unit and close the lever arm. Install a cleaning solution (max 1% NaOCl)
inside the EC cartridge compartment and insert the three tubes which are tied together. Guide
the single tube into an empty waste bottle. Confirm successful insertion of the components by
pressing the corresponding status button. The cleaning procedure is automatically initiated.

Figure 219

Figure 220

EC 90 User Manual 129

 MAINTENACE

8. After CLEANING has been completed, remove the cleaning solution from the EC cartridge
compartment and confirm the removal by pressing the corresponding status button. Steps 7
and 8 are repeated three times.

Figure 221

9. Install a full botte of DI water inside the EC cartridge compartment and re-insert the three
tubes. Confirm successful insertion by pressing the corresponding status button. The washing
procedure is automatically initiated.

Figure 222

Figure 223

10. After WASHING has been completed, remove the water bottle from the EC cartridge
compartment and confirm the removal by pressing the corresponding status button. Steps 9
and 10 are repeated three times.

Figure 224

11. The EMPTYING procedure is automatically initiated. The status is displayed in the progress bar.
Once the procedure has been completed, the operator can continue.

EC 90 User Manual 130

 MAINTENACE

12. Remove the washing unit and waste bottle from the cartridge compartment and confirm the
removal by pressing the corresponding status button.

Figure 225

13. Reinstall the old or insert a new cartridge according to the following procedure:
a) Remove the cap (A) and cap sealing (B) from the new EC cartridge and insert the EC
Biosensor (C) (if applicable).

Figure 226

EC 90 User Manual 131

 MAINTENACE

b) Insert the EC cartridge until stop.

Figure 227

c) Carefully close the lever arm (A). As the correct insertion of the cartrige is essential for
successfully establishing the fluidic and electrical connection, a built-in security feature will
assist the operator (B).

Figure 228

EC 90 User Manual 132

 MAINTENACE

d) If the cartridge has been correctly inserted, the front door can be closed.

Figure 229

e) Confirm successful cartridge insertion by pressing the corresponding status button.

Figure 230

14. The PRIME UP and CALIBRATION procedures are initiated automatically. The status is displayed
in the progress bar. During prime-up, the initial aspiration of the reference and calibration
solutions is performed and verified.
15. If a new EC cartridge is inserted the WETTING will start automatically. For wetting plasma,
serum or blood can be used. Follow the on-screen instructions until completion. It is required
to perform 10 wetting cycles. The status is displayed in the progress bar.

Figure 231

EC 90 User Manual 133

 MAINTENACE

16. This procedure is followed by an automatic 2-point calibration. Once the procedures have
been completed the window will close automatically.

Figure 232

5.6.4 Cleaning the EC cartridge compartment

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

To avoid unnecessary waste of reagents, it is recommended to clean the cartridge compartment

Hint when a cartridge removal is required (for example during the CHANGE EC CARTRIDGE or after the
SHUTDOWN routine).

1. Open the front door (A) and lift the lever arm up (B).

Figure 233

2. Remove the EC cartridge by pulling carefully.

EC 90 User Manual 134

 MAINTENACE

Figure 234

The cartridge must be removed with caution to prevent the spilling of potentially infectious liquids.
Avoid denting or crushing the cardboard by exerting pressure on the side walls.

3. Use a disposable cloth dampened in one of the specified disinfectants (e.g. 3% NaClO) to wipe
the compartment.
4. Check the fluidic connector for crystallisation and clean with an appropriate tool if required.
5. Close the front door.

EC 90 User Manual 135

 MAINTENACE

5.6.5 Replacing printer paper rolls

1. Open the printer flap and remove the used paper roll core from the well.

Figure 235

2. Insert the new printer paper roll. Make sure that the end of the rolls feeds up from the bottom
and not the top.

Figure 236

3. Close the printer flap and make sure that the paper is properly positioned between the flap
and instrument housing.

Figure 237

The heat-sensitive coating of the printer paper is only single-sided. It must therfore be ensured
Hint
that the paper roll is inserted correctly.

EC 90 User Manual 136

 MAINTENACE

5.6.6 System and performance tests

1. Press the corresponding button in the maintenance menu.

Figure 238

2. To perform one of the tests press the respective button or select/disselect the field.

Figure 239

Each filling routine reduces the filling level, thus the operating time and the remaining samples can
Hint
be reduced.

EC 90 User Manual 137

 MAINTENACE

5.7 Records
All data concerning the device, the RFID or the processes are stored in the records. To find the
information press on the corresponding button in the maintenance menu.

Figure 240

As a default, the table of the LOG records is displayed. By pressing the corresponding button the user
can switch between LOG, RFID and INSTRUMENT records. Use the horizontal scrolll bar to display all
columns. By pressing the vertical arrow buttons the entire record table can be scanned. For the LOG
and INSTRUMENT table there is the possibility to set a filter and export the data. Furthermore, there
is the option to generate a QR code with the information of these tables. This can be done by pressing
the QR button. On request, the code can be photographed and sent to the service team for
troubleshooting.

Figure 241

EC 90 User Manual 138

 MAINTENACE

Figure 242

Read For information on how to filter and export data, please refer to chapter 4 Operation Results and
read the respective sections starting on page 53.

EC 90 User Manual 139

 MAINTENACE

5.8 Shutdown for long-term storage

A full shutdown of the instrument should only be performed in case of long-term storage. Do
not use this feature if you want to continue using the EC cartridge. For short-term periods
Attention!
during which the instrument will not be operated, preferably use the economy mode to save
liquid reagents.

If the instrument will be out of operation over a long period of time – for example during long-term
storage – a proper shutdown procedure must be performed. This procedure consists of several
maintenance routines and steps:

• Pre-shutdown maintenance
- Consists of preparatory tasks which should be performed before shutdown

• Actual shutdown of the instrument

- Refers to the initiation of the SHUTDOWN routine

• Post-shutdown maintenance
- Consists of tasks which must be performed after the instrument has been fully switched
off

5.8.1 Pre-shutdown maintenance

Before shutting down the system, it is recommended to export important data to a USB flash drive.

For information on how to perform a data backup, please refer to chapter 4 Operation and read
Read
section Exporting and deleting data on page 59.

EC 90 User Manual 140

 MAINTENACE

5.8.2 Performing shutdown

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

1. Press the corresponding button in the maintenance menu.

Figure 243

2. Initiate the shutdown routine by pressing SHUT DOWN.

Figure 244

3. The SHUT DOWN pop-up window opens. Follow the on-screen instructions until completion.

Figure 245

4. The EMPTYING procedure is initiated automatically. The status is displayed in the progress bar.
Once the procedure has been completed, the operator can continue.
5. Remove the currently installed EC cartridge according to the following procedure:

EC 90 User Manual 141

 MAINTENACE

a) Open the front door (A) and lift the lever arm up (B).

Figure 246

b) Remove the EC cartridge by pulling carefully.

Figure 247

The cartridge must be removed with caution to prevent the spilling of potentially infectious liquids.
Avoid denting or crushing the cardboard by exerting pressure on the side walls.

6. Insert the washing unit. Install a full bottle of DI water inside the EC cartridge compartment
and insert the three tubes which are tied together. Guide the single tube into an empty waste
bottle. Confirm successful insertion of the components by pressing the corresponding status
button. The washing procedure is automatically initiated.

Figure 248

EC 90 User Manual 142

 MAINTENACE

Figure 249

7. After WASHING has been completed, remove the water bottle from the EC cartridge
compartment and confirm the removal by pressing the corresponding status button.

Figure 250

8. The EMPTYING procedure is automatically initiated. The status is displayed in the progress bar.
Once the procedure has been completed, the operator can continue.
9. Remove the washing unit and waste bottle from the cartridge compartment and confirm the
removal by pressing the corresponding status button.

Figure 251

10. Press the provided status button to initiate the instrument shutdown.

Figure 252

EC 90 User Manual 143

 MAINTENACE

11. The screen will go dark and an information pop-up window opens. To fully shut down the
instrument, the toggle switch must now be flipped to the OFF position (O).

Figure 253

5.8.3 Post-shutdown maintenance

Pay attention to the warning labels. These components must be handled with care!
Wear protective gloves! Risk of infection!

The instrument must be prepared for long-term storage by performing the following maintenance
routines and steps:

• Decontamination of the instrument

- instrument surfaces
- touch screen
- sample aspiration unit
- EC cartridge compartment

• Relaxation of the peristaltic pump tubing

• Insertion of valve tube clips

For information on how to perform decontamination, please read the corresponding sections for
Read
each component.

EC 90 User Manual 144

 MAINTENACE

1. Open the maintenance door to access the pump tube and valve tubes 1 – 3.

Figure 254

2. Unscrew the back screws and remove the left side panel to access valve tube 5.

Figure 255

EC 90 User Manual 145

 MAINTENACE

3. Relax the pump tube by rotating the lever of the peristaltic pump to the lower position (until
stop).

Figure 256

4. Insert the tube clips into each valve head V1, V2, V3 and V5

Figure 257

EC 90 User Manual 146

 MAINTENACE

Figure 258

Ensure that electrical wire connections are not loosened during clip insertion into valve 2. Note
Attention!
that sufficient force must be applied to properly insert the tube clips.

Hint If the instrument will be transported, the protective foam block must also be inserted.

5. Reinstall the left side panel and close the maintenance door.

EC 90 User Manual 147

 SETUP

6 Setup
6.1 Set-up menu overview
The setup menu allows the operator to retrieve information and configure the instrument for the
laboratory use. Depending on the user level, the available submenus can be accessed by pressing the
corresponding icon buttons.

Figure 259

The following table provides a brief overview of the available settings which can be configured for the
individual submenus.
Table 20

Short description of available settings

Operation Configure settings for sample measurements and results evaluation as well as for
settings calibration and eco mode intervals
Printer Enable/disable automatic printing of results and configure printout header
LIS Establish and configure communication with the laboratory information system
System Configure global system settings such as time, date, sound, language and lights
Users Add, modify and delete user accounts for the instrument
SW Update Initiate the installation of a new software version
QC settings Configure how to deal with out-of-control results and select Westgard rules
Info View system information about the instrument, components and software

Read For detailed information on the individual submenu settings, please read the corresponding
sections of this chapter.

EC 90 User Manual 148

 SETUP

6.2 Operation settings

Hint The operation settings submenu can only be accessed by Admin level users.

1. Press the corresponding button in the setup menu.

Figure 260

2. The OPERATION SETTINGS pop-up window opens. From this submenu the operator can
a) enable/disable and adjust the economy mode – this feature allows the operator to auto-
matically activate the eco mode according to regular time or day intervals.

Figure 261

b) adjust the time intervals for 1-point and 2-point calibrations.

EC 90 User Manual 149

 SETUP

Figure 262

c) adjust the parameter units shown in the results menu table.

Figure 263

EC 90 User Manual 150

 SETUP

d) set correlation adjustment values – this feature allows the operator to obtain measurement
values equivalent to values determined by other instruments measuring electrolyte param-
eters. The values are applied for patient measurements but not for QC measurements.

Figure 264

e) enable/disable the comparison of measurement results to standard reference values, select

the sample type and between adults and children, set new standard reference values.

Figure 265

EC 90 User Manual 151

 SETUP

6.3 Printer

Hint The printer submenu is accessible for all user levels.

1. Press the corresponding button in the setup menu.

Figure 266

2. The PRINTER pop-up window opens. This submenu allows the operator to
a) enable/disable automatic printing of sample measurement and QC results and
b) configure the printout header to include the name of the operator, address of the labora-
tory and patient information.

Figure 267

EC 90 User Manual 152

 SETUP

Figure 268

Hint By default, automatic printing of results is disabled.

EC 90 User Manual 153

 SETUP

6.4 LIS

Hint The LIS settings submenu can only be accessed by Admin level users.

The EC 90 series provides a connection to a Laboratory Information System (LIS). The connection can
be established either via LAN or RS232. To establish the connection, plug in the corresponding cable
and follow the steps below:
1. Press the corresponding button in the setup menu.

Figure 269

2. The LIS pop-up window opens. From this submenu the operator can
a) enable/disable the LIS connection
b) select between LAN connection or RS232 connection
3. If LAN connection is selected it is possible to
a) enter the ASTM Host and ASTM Port in the corresponding fields
b) enable/disable the automatic obtaining of the IP address , the Netmask and the Gateway
by checking the DHCP box, otherwise these data must be entered manually
4. If RS232 connection is selected there are no more entries needed

Figure 270

EC 90 User Manual 154

 SETUP

Figure 271

If the LIS connection is established, it is indicated by the LIS symbol in the bottom bar.

Figure 272

Read For information on how to export data via LIS, please refer to chapter 4 Operation Results and
read the respective sections starting on page 53.

6.5 System

Hint The system settings are accessible for all user levels.

1. Press the corresponding button in the setup menu.

Figure 273

EC 90 User Manual 155

 SETUP

2. The SYSTEM pop-up window opens. From this submenu the operator can
a) Change the software language, set the date and change the date format, set the time and
change the time format

Figure 274

b) Adjust the sound volume level or mute the system

Figure 275

EC 90 User Manual 156

 SETUP

c) enable/disable the proximity sensor and adjust its sensitivity

Figure 276

d) enable/disable the light illuminating the sample aspiration unit

Figure 277

EC 90 User Manual 157

 SETUP

e) adjust the sensitivity and the reaction time of the touch screen and test the settings

Figure 278

Read For information on how to use the proximity sensor please refer to chapter 4 Operation and read
the section Performing measurements starting on page 47.

EC 90 User Manual 158

 SETUP

6.6 Users

Hint Only Admin level users can access the users submenu to add, modify or delete new users.

1. Press the corresponding button in the setup menu.

Figure 279

2. The USERS pop-up window opens.

Figure 280

This submenu enables the configuration of user accounts for the instrument. The provided
table lists the existing accounts in descending order of operator ID. This ID is a consective
number which is automatically assigned during account creation. Additionally, the entries
show the operator name and access rights that were assigned to each user. Via scroll bar the
entire list of operators may be scanned. Individual user accounts may be selected for
modification or deletion by tipping on the respective record.

6.6.1 Adding user accounts

1. To add a new user account, press the respective button provided in the setup submenu USERS.

Figure 281

EC 90 User Manual 159

 SETUP

2. The ADD pop-up window opens.

Figure 282

a) Assign the level of access by pressing the corresponding USER or ADMIN button
b) Enter the new operator name (4 – 10 characters)
c) Enter and confirm the password (4 – 10 characters)
d) Press the SAVE button to save all changes and close the pop-up window.

6.6.2 Modifying user accounts

1. Select the user account by tipping on the respective record.
2. Press the matching button provided in the setup submenu USERS.

Figure 283

3. The MODIFY pop-up window opens. Edit the existing user account as desired. Press SAVE to
save all changes and close the pop-up window.

Figure 284

EC 90 User Manual 160

 SETUP

6.6.3 Deleting user accounts

1. Select the user account by tipping on the respective record.
2. Press the matching button provided in the setup submenu USERS.

Figure 285

3. Confirm that you want to delete the user account by pressing DELETE.

Figure 286

Hint The operator name will be deleted from all results, QC results and calibration slope and 1P tables.

Hint UserOne cannot be deleted, but can be modified.

EC 90 User Manual 161

 SETUP

6.7 SW Update

Only Admin level users can initiate a software update installation. To upgrade your EC 90
Hint
Analyzer please refer to your local service engineer or distributor.

Attention!
By performing a software update, all calibration and results data may be deleted from the
instrument! It is also possible that users may be deleted!

Attention!
The current software version will be deleted when the update is started.

1. Press the corresponding button in the setup menu.

Figure 287

2. Insert a USB stick with the new software and the appropriate language file. Make sure that no
old software or language file is stored on the USB stick. There are two language packs available
– the default one consists of: English, German, French, Spanish, Portuguese. The other pack
cosisits of: English, Polish, Czech, Ukrainian, Russian. If you want to use Slavic lanugaes in your
instrument, please contact your local service.
3. Confirm that you want to update the software of the instrument by pressing UPDATE.

Figure 288

4. Wait until the system has shut down (screen will go dark).
5. The system performs the software update and is ready to use after the reboot.

EC 90 User Manual 162

 SETUP

Only use USB sticks with FAT or FAT32 formatting. Other formats might not work on the
Hint
instrument.

6.8 QC settings

Hint The QC settings submenu can only be accessed by Admin level users.

1. Press the corresponding button in the setup menu.

Figure 289

2. The QC SETTINGS pop-up window opens.

Figure 290

From this submenu the operator is able to

a) Configure how out-of-control measurements are handled. The level of strictness can be set
to:
• None
QC measurement results will not have any effect on the parameter status. In case
of out-of-control measurements, no warning will be triggered and parameters will
not be locked in the main screen.

• Warning

EC 90 User Manual 163

 SETUP

The operator will be warned if parameters are out-of-control. In this case the main
screen parameter status will indicate “QC not OK”.

EC 90 User Manual 164

 SETUP

• Locking
The out-of-control parameters will be locked in the main screen and therefore
cannot be measured.
Warning or locking can be removed by a valid QC measurement with the same material and
level. Alternatively, Admin level users can manually remove locks by pressing the provided
button in the QC settings submenu (see Figure 290).

b) Select the Westgard rules which are used for evaluation of QC results.
Westgard rules/multirules
Westgard rules use statistical methods such as mean value (x ) and standard deviation () to
determine out-of-control measurements. The combination of several rules leads to a multirule
QC procedure. The following rules are available and may be selected for evaluation:
Table 21

Rule Description
13 A single control measurement exceeds the x ± 3 limit
12 A single control measurement exceeds the x ± 2 limit
22 Two consecutive control measurements exceed the x ± 2 limit
7T Seven control measurements trend in the same direction
2of32 Two out of three control measurements exceed the x ± 2 limit
One consecutive control measurement in a group exceed the x + 2 limit and
R4
another one of the group exeed the x - 2 limit
41 Four consecutive control measurements exceed the x ± 1 limit
10x Ten consecutive control measurements fall on one side of the x

By default, the operator is not actively informed about out-of-control measurements (no warning
Hint
triggered or locking of parameters) and only the 13 control rule is selected.

EC 90 User Manual 165

 SETUP

6.9 Info

Hint The info submenu is accessible for all user levels.

1. Press the corresponding button in the setup menu.

Figure 291

2. The INFO pop-up window opens. From this submenu, technical information on the instrument
can be retrieved. This includes the
a) instrument type and serial number as well as
b) versions of the software, user interface and electrical components.

Figure 292

EC 90 User Manual 166

 TROUBLESHOOTING

7 Troubleshooting
7.1 General guidance
This chapter is designed to assist the operator with identifying and solving information, warning and
error events which may occur during regular operation of the instrument. It also provides instructions
how to get technical assistance from Customer Support.

The first step is to understand the normal operation and required preventive maintenance of the
analyser. A good working experience with the analyser is essential for a successful troubleshooting.

EC 90 User Manual 167

 TROUBLESHOOTING

7.2 Performing troubleshooting

Troubleshooting can be divided into two logical steps:

1) Identification of the event

The operator should be able to identify the event by receiving information, warnings and error
messages on the screen indicating what kind of incident has been detected. There are several ways
how an event will be depicted on the display:

• Parameter status in the main screen

- deactivated
- not calibrated
- QC not ok

• Information, error and warning pop-ups

For several events, the system notice in the bottom bar will display messages after closing the
respective pop-up window:
- EC CARTRIDGE EXPIRED
- PUMP CAL NOT OK
- PRIME UP FAILED
- MEMORY SPACE EXCEEDED
- QC MEMORY SPACE EXCEEDED
• Event codes and info icon in the results, QC results or calibration slope/1P screens
Errors and other events are indicated either by information icons (arrows, exclamation mark)
in the error flag column and next to the measured calibration, sample and QC values, or by
receiving error and message codes (e.g. M001, E003) for the affected parameters. By pressing
the event info icon button an information pop-up window with the description of the detected
event appears.

2) Corrective actions
Many errors occurring during normal operation can be effortlessly corrected by the operator alone or
with additional assistance from Customer Service. Common events and their respective corrective
actions are listed in the following tables, starting on page 169.

If issues cannot be resolved according to the instructions given below, or additional technical
assistance is required, please contact Customer Service providing the following information:
• Instrument model and serial number
• Description of the event and operating environment
• Lot number of EC cartridge
• Related data and report

EC 90 User Manual 168

 TROUBLESHOOTING

7.2.1 Parameter status warnings

Table 22

Warning Probable causes Corrective actions

Deactivated Parameter deselected (1) Press to activate

Not calibrated Unsuccessful calibration of (1) Smart calibration (CAL FOR READY)
single/multiple parameters (2) Check calibration slope/1P screens
a) Identity event (see chapters Events
related to analyser processes and Events
related to parameters)
b) Perform corrective actions according to
troubleshooting instructions

QC not ok QC rule violation (warning or (1) Check QC results screen

locking activated) a) Identify QC rule violation (see chapter
Events related to out-of-control
measurements)
b) Perform corrective actions according to
troubleshooting instructions

EC 90 User Manual 169

 TROUBLESHOOTING

7.2.2 Events indicated by error and warning pop-ups

Table 23

Error/warning Probable causes Corrective actions

CAL1 prime up Aspiration of CAL1 reagent (1) Press PRIME UP to continue
failed failed due to: (2) Check EC cartridge status (sufficient reagents)
Valve clip not removed (3) Perform CAL1 filling routine (TESTS)
(4) Check Valve 3 (TESTS) and valve tube
Blocked or leaking fluidic
(5) Initiate CHANGE EC CARTRIDGE routine
path
a) Check fluidic connector on instrument for
Clogged sample needle or
crystallisation and clean with an
needle block
appropriate tool if required
Leaking fluidic fittings b) Reinsert current EC cartridge
EC cartridge error c) Insert new EC cartridge

CAL2 prime up Aspiration of CAL2 reagent (1) Press PRIME UP to continue

failed failed due to: (2) Check pump tube
Lever arm not closed (3) Check EC cartridge status (sufficient reagents)
(4) Check for correct insertion of EC cartridge
Pump tube not clamped
(5) Perform CAL2 filling routine (TESTS)
Valve clip not removed
(6) Check Valve 1 (TESTS) and valve tube
Blocked or leaking fluidic (7) Check sample needle and needle block for
path clogging
Clogged sample needle or (8) Initiate CHANGE EC CARTRIDGE routine
needle block a) Check fluidic connector on instrument for
Leaking fluidic fittings crystallisation and clean with an
appropriate tool if required
EC cartridge error
b) Reinsert current EC cartridge
c) Insert new EC cartridge

KCl prime up failed Aspiration of KCl reagent (1) Press OK to continue

failed due to: (2) Check EC cartridge status (sufficient reagents)
Valve clip not removed (3) Perform KCl filling routine (TESTS)
(4) Check Valve 5 (TESTS) and valve tube
Blocked or leaking fluidic
(5) Initiate CHANGE EC CARTRIDGE routine
path
a) Check fluidic connector on instrument for
Clogged sample needle or
crystallisation and clean with an
needle block
appropriate tool if required
Leaking fluidic fittings b) Reinsert current EC cartridge
EC cartridge error c) Insert new EC cartridge

Please change EC EC cartridge expires or runs (1) Press CHANGE to reinitialise system (quit
cartridge within out of reagents while economy mode)
the next <#> days analyser is in economy mode (2) Initiate CHANGE EC CARTRIDGE routine
(3) Insert new EC cartridge

EC 90 User Manual 170

 TROUBLESHOOTING

Error/warning Probable causes Corrective actions

Parameter slope is Slope values out of range (1) Press CHANGE or OK to continue
out of range. Option 1:
Please deactivate
(2) Deactivate the parameter
parameter or
a) Switch to main screen
change the
b) Click on the corresponding parameter to
biosensor.
deactivate it
Option 2:
(2) Smart calibration (CAL FOR READY)
(3) Initiate WETTING routine
(4) Change the Biosensor
a) Initiate CHANGE EC CARTRIDGE routine
b) Change the biosensor manually
a) Reinsert current EC catridge

Code not matching Incorrect EC cartdrige code (1) Initiate CHANGE EC CARTRIDGE routine
(2) Insert new EC cartridge with correct code

Pump calibration Pump calibration values out (1) Press OK (reinitialises system when in
failed. Please of range economy mode)
change the pump Pump tube worn out (2) Initiate REPLACE PUMP TUBE routine
tube a) Change pump tube
Limited (QC) Internal memory nearly full (1) Press OK
memory space (2) Apply filter (optional)
available. Please (3) Initiate REPORT routine by pressing on export
back up and delete icon button
data. a) Back up desired data
b) Confirm to delete data

(QC) Memory Internal memory full (1) Press OK

space exceeded. (2) Apply filter (optional)
Please back up and (3) Initiate REPORT routine by pressing on export
delete data. icon button
a) Back up desired data
b) Confirm to delete data

EC cartridge not RFID tag missing or defect (1) Initiate rereading of RFID tag (TESTS)
detected RFID reader error (2) Check if RFID tag is available on EC cartridge
(3) Insert new EC cartridge

EC cartridge End of service life (days in (1) Check EC cartridge status

service life use) has been reached (2) Check date and time
exceeded (3) Press CHANGE
(4) Initiate CHANGE EC CARTRIDGE routine
(5) Insert new EC cartridge

EC 90 User Manual 171

 TROUBLESHOOTING

Error/warning Probable causes Corrective actions

Maximum number End of service life has been (1) Initiate CHANGE EC CARTRIDGE routine
of measurements reached (all measurements (2) Insert new EC cartridge
reached have been consumed)
EC cartridge End of shelf life reached (1) Check EC cartridge status
expired (2) Check date and time
(3) Press CHANGE
(4) Initiate CHANGE EC CARTRIDGE routine
(5) Insert new EC cartridge

Reagents empty EC cartridge reagents empty (1) Initiate CHANGE EC CARTRIDGE routine
(2) Insert new EC cartridge

Printer door not Printer door is open (1) Close the printer door
closed!

Printer paper No paper in the printer (1) Insert paper in the printer
missing!
Incompatible
Incompatible language file, (1) Remove the USB stick
language file.
the software update and the (2) Save the correct language file on the stick
Please repeat the
language file do not (3) Insert the USB stick
installation with
correspond (4) Press OK
<language file>
Removed EC cartridge while
(1) Do not remove EC cartridge while processing
Cancelled calibration
(2) Keep the flap closed while processing
Open flap while calibration

EC 90 User Manual 172

 TROUBLESHOOTING

7.2.3 Events related to analyser processes

Table 24

Icon Description Probable causes Corrective actions

Cal1 filling Measurement chamber not (1) Initiate 1-point calibration
filled (2) Perform CAL1 filling routine (TESTS)
Fluidic error (3) Initiate CHANGE EC CARTRIDGE
routine
a) Reinsert current EC cartridge, or
b) Insert new EC cartridge
KCl filling KCl filling not OK (1) Initiate 1-point calibration
(2) Perform KCl filling routine (TESTS)
(3) Check valve 5 (TESTS)
(4) Initiate CHANGE EC CARTRIDGE
routine
a) Reinsert current EC cartridge, or
b) Insert new EC cartridge
(5) Check fluidic connector on instrument
for crystallisation and clean with an
appropriate tool if required
CAL2 detection CAL2 filling not OK (1) Smart calibration (CAL FOR READY)
Flap not closed (2) Perform CAL2 filling routine (TESTS)
(3) Check valve 3 (TESTS)
Bubble sensor error
(4) Check air tube (valve 4) for
crystallisation
(5) Perform cleaning routine
(6) Initiate CHANGE EC CARTRIDGE
routine
a) Reinsert current EC cartridge, or
b) Insert new EC cartridge
(7) Check fluidic connector on instrument
for crystallisation and clean with an
appropriate tool if required
CAL 2 volume CAL2 volume too small (1) Initiate 2-point calibration
Sample sensor error (2) Perform CAL2 filling routine (TESTS)
(3) Check valve 3 (TESTS)
(4) Check EC cartridge status (sufficient
reagents)
CAL2 positioning Air bubbles in calibration (1) Smart calibration (CAL FOR READY)
solution (2) Check EC cartridge status
(3) Check air tube (valve 4) for
cristallization
(4) Perform CAL2 filling routine (TESTS)

EC 90 User Manual 173

 TROUBLESHOOTING

(5) Initiate CHANGE EC CARTRIDGE

routine
a) Check sensor contacts and contact
pins in instrument for wetness and
dry contacts if required
b) Insert new EC cartridge
Sample detection Sample filling not OK (1) Repeat measurement with new
Sample not detected sample
(2) Check aspiration needle for clogging
Inappropriate sample

Icon Description Probable causes Corrective actions

Sample volume Sample volume too small (1) Repeat measurement with
Sample removed too fast a) Sufficient sample volume
from sample needle b) Sample free of bubbles
Air bubbles in sample

Sample Insufficient sample volume (1) Repeat measurement with

positioning Air bubbles in measurement a) Sufficient sample volume
chamber b) Sample free of bubbles
c) New sample
Inappropriate sample
CAL1 detection CAL1 filling not OK (1) Smart calibration (CAL FOR READY)
Flap not closed (2) Perform CAL1 filling routine (TESTS)
(3) Check valve 3 (TESTS)
Sample sensor error
(4) Check air tube (valve 4) for
crystallisation
(5) Initiate “Change EC cartridge” routine
a) Reinsert current EC cartridge, or
b) Insert new EC cartridge
(6) Check fluidic connector on instrument
for crystallisation and clean with an
appropriate tool if required
CAL1 volume CAL1 volume too small (1) Initiate 1-point calibration
Sample sensor error (2) Perform CAL1 filling routine (TESTS)
(3) Check valve 3 (TESTS)
(4) Check EC cartridge status
CAL1 positioning Air bubbles in calibration (1) Smart calibration (CAL FOR READY)
solution (2) Check EC cartridge status
(3) Check air tube (valve 4) for
cristallization
(4) Perform CAL1 filling routine (TESTS)

EC 90 User Manual 174

 TROUBLESHOOTING

(5) Initiate CHANGE EC CARTRIDGE

routine
a) Check sensor contacts and contact
pins in instrument for wetness and
dry contacts if required
b) Insert new EC cartridge
Signal acquisition Electric contact failure (1) Initiate CHANGE EC CARTRIDGE
between instrument and routine
sensor a) Check sensor contacts and contact
pins in instrument for wetness and
dry contacts if required
b) Check spring contact pins for
proper alignment and
contamination
c) Reinsert EC cartridge
(2) Switch off the instrument (toggle
switch)
Pump calibration Pump calibration values out (1) Press OK (reinitialises system when in
of range economy mode)
Pump tube worn out (2) Initiate REPLACE PUMP TUBE routine
a) Change pump tube

Icon Description Probable causes Corrective actions

Open flap Flap was not closed after (1) Close flap and repeat measurement
timeout sample aspiration during
measurement routine

EC 90 User Manual 175

 TROUBLESHOOTING

7.2.4 Events related to parameters

Table 25

Code Description Probable causes Corrective actions

M001 No valid slope Calibration failure (1) Smart calibration (CAL FOR READY)
value
E003 Adjustment curve Electric contact failure (1) Initiate CHANGE EC CARTRIDGE
error routine
a) Check sensor contacts and contact
pins in instrument for wetness and
dry contacts if required
b) Check spring contact pins for
proper alignment and
contamination
c) Reinsert EC cartridge
(2) Switch off the instrument (toggle
switch)

E004 Out of range (↓) Slope/1-point calibration (1) Smart calibration (CAL FOR READY)
values out of range (below (2) Initiate WETTING routine
lower limit) (3) Initiate CHANGE EC CARTRIDGE
routine
a) Insert new EC cartridge or EC
Biosensor

E005 Out of range (↑) Slope/1-point calibration (1) Smart calibration (CAL FOR READY)
values out of range (above (2) Initiate WETTING routine
upper limit) (3) Initiate CHANGE EC CARTRIDGE
routine
a) Insert new EC cartridge or EC
Biosensor

E006 Repro nOK EC Biosensor failure (1) Smart calibration (CAL FOR READY)
(2) Initiate WETTING routine
(3) Initiate CHANGE EC CARTRIDGE
routine
a) Reinsert current EC cartridge, or
b) Insert new EC cartridge or EC
Biosensor
E007 1-point error CAL1 value failure during (1) Initiate 1-point calibration
calibration or after (2) Initiate WETTING routine
measurement (3) Repeat measurement with new
(inappropriate sample) sample

EC 90 User Manual 176

 TROUBLESHOOTING

Code Description Probable causes Corrective actions

E008 No Na value Na sensor not calibrated (1) Check if Na parameter is activated on

Na value of sample out of instrument
range (2) Smart calibration (CAL FOR READY)
(3) Measure new sample
Na parameter deactivated
(4) Initiate CHANGE EC CARTRIDGE
on instrument
routine
a) Insert new EC cartridge or EC
Biosensor
M010 Not determined Parameter deactivated (1) Activate required parameters

Out of reference Electrolyte value below (1) Deactivate comparison to standard

↓ range (↓) physiological range reference values in setup menu
(2) Check reference values

Out of reference Electrolyte value above (1) Deactivate comparison to standard

↑ range (↑) physiological range reference values in setup menu
(2) Check reference values

Out of Electrolyte value below -

measurement specified measuring range
↓↓
range (↓) (correctness not
guaranteed)
Out of Electrolyte value above -
measurement specified measuring range
↑↑
range (↑) (correctness not
guaranteed)
M020 Out of display Eletrolyte value below -
range (↓) displayable range
M021 Out of display Eletrolyte value above -
range (↑) displayable range

EC 90 User Manual 177

 TROUBLESHOOTING

7.2.5 Events related to out-of-control measurements

Table 26

Code Description Probable causes Corrective actions

M002 QC warning QC rule violation (1) Check target values for QC material
(2) Repeat QC measurement
(3) Use new QC vial
(4) Initiate CHANGE EC CARTRIDGE
routine
a) Insert new EC Biosensor
E009 QC locked QC rule violation (1) Check target values for QC material
(2) Repeat QC measurement
(3) Use new QC vial
(4) Cancel QC lock (admin rights
required)
(5) Initiate CHANGE EC CARTRIDGE
routine
a) Insert new EC Bioensor
M011 QC violation 13 for Violation of Westgard rule (1) Check target values for QC material
<parameter> (2) Repeat QC measurement
(3) Use new QC vial
(4) Cancel QC lock (admin rights
required)
(5) Initiate CHANGE EC CARTRIDGE
routine
a) Insert new EC Biosensor

M012 QC violation12 for Violation of Westgard rule (1) Check target values for QC material
<parameter> (2) Repeat QC measurement
(3) Use new QC vial
(4) Cancel QC lock (admin rights
required)
(5) Initiate CHANGE EC CARTRIDGE
routine
a) Insert new EC Bioensor

EC 90 User Manual 178

 TROUBLESHOOTING

M013 QC violation 22 for Violation of Westgard rule (1) Check target values for QC material
<parameter> (2) Repeat QC measurement
(3) Use new QC vial
(4) Cancel QC lock (admin rights required)

(5) Initiate Change EC cartridge routine

a) Insert new EC Biosensor

M014 QC violation 2of32 Violation of Westgard rule (1) Check target values for QC material
for <parameter> (2) Repeat QC measurement
(3) Use new QC vial
(4) Cancel QC lock (admin rights required)
(5) Initiate CHANGE EC CARTRIDGE routine
a) Insert new EC Biosensor

M015 QC violation 7T for Violation of Westgard rule (1) Check target values for QC material
< parameter > (2) Repeat QC measurement
(3) Use new QC vial
(4) Cancel QC lock (admin rights required)
(5) Initiate CHANGE EC CARTRIDGE routine
a) Insert new EC Biosensor

M022 QC violation R4σ for Violation of Westgard rule (1) Check target values for QC material
< parameter > (2) Repeat QC measurement
(3) Use new QC vial
(4) Cancel QC lock (admin rights required)
(5) Initiate CHANGE EC CARTRIDGE routine
a) Insert new EC Biosensor

M0M023 QC violation 41σ for Violation of Westgard rule (1) Check target values for QC material
< parameter > (2) Repeat QC measurement
(3) Use new QC vial
(4) Cancel QC lock (admin rights required)
(5) Initiate CHANGE EC CARTRIDGE routine
a) Insert new EC Biosensor

EC 90 User Manual 179

 TROUBLESHOOTING

Code Description Probable causes Corrective actions

M024 QC violation 10x Violation of Westgard rule (1) Check target values for QC material
for < parameter > (2) Repeat QC measurement
(3) Use new QC vial
(4) Cancel QC lock (admin rights required)
(5) Initiate CHANGE EC CARTRIDGE routine
a) Insert new EC Biosensor

EC 90 User Manual 180

 ANALYTICAL PERFORMANCE

8 Analytical performance
8.1 Precision

8.1.1 Plasma
Typical within-run (Swr) and between-day (Sdd) precisions of an EC 90 Electrolyte Analyser were
obtained using a plasma-based QC material. The control material was run in replicates of two twice a
day for 20 days (N = 80).
Table 27

Mean Within run Between-day

Analyte
[mmol/L] SDwr %CV SDdd %CV
Na+ 132.5 0.4 0.3 1.2 0.9
+
K 4.5 0.02 0.5 0.04 1.0
2+
iCa 0.7 0.01 - 0.02 -
Cl- 100.5 0.2 0.2 0.9 0.8

8.2 Accuracy

8.2.1 Plasma – NIST

Accuracy for plasma was obtained from measurements of plasma-based NIST standard material (3
levels) on EC 90 Electrolyte Analysers. The bias results were calculated by substracting the mean of the
measurement results from the target values of the NIST material.
Table 28

Mean Target Bias Specification

Level N per level
[mmol/L] [mmol/L] [mmol/L] [mmol/L]
1 16 118.4 120.0 1.6 ± 3.0
+
Na 2 16 138.2 139.3 1.1 ± 3.5
3 16 157.9 158.7 0.8 ± 3.9

Table 29

Mean Target Bias Specification

Level N per level
[mmol/L] [mmol/L] [mmol/L] [mmol/L]
1 16 5.73 5.75 0.02 ± 0.23
+
K 2 16 3.74 3.73 -0.01 ± 0.15
3 16 1.62 1.61 -0.01 ± 0.06

EC 90 User Manual 181

 ANALYTICAL PERFORMANCE

Table 30

Mean Target Bias Specification

Level N per level
[mmol/L] [mmol/L] [mmol/L] [mmol/L]
1 16 1.72 1.77 0.05 ± 0.08
iCa2+ 2 16 1.47 1.47 0.00 ± 0.07
3 16 1.18 1.17 -0.01 ± 0.06

Table 31

Mean Target Bias Specification

Level N per level
[mmol/L] [mmol/L] [mmol/L] [mmol/L]
1 16 96.7 94.5 -2.2 ± 3.8
-
Cl 2 16 110.1 108.5 -1.6 ± 4.3
3 16 124.5 122.6 -1.9 ± 4.9

8.2.2 Aqueous – Gravimetry

Accuracy for aqueous solutions was obtained from measurements of 5 levels of electrolyte aqueous
solutions with EC 90 Electrolyte Analysers. The bias results were calculated by substracting the mean
of the measurement results from the gravimetric target values.
Table 32

Mean Target Bias Specification

Level N per level
[mmol/L] [mmol/L] [mmol/L] [mmol/L]
1 20 176.5 180.0 3.5 ± 4.5
2 20 148.3 150.0 1.7 ± 3.8
+
Na 3 20 124.9 126.0 1.1 ± 3.2
4 20 102.5 105.0 2.5 ± 2.6
5 20 86.8 88.0 1.2 ± 2.2

Table 33

Mean Target Bias Specification

Level N per level
[mmol/L] [mmol/L] [mmol/L] [mmol/L]
1 20 7.96 8.00 0.04 ± 0.32
2 20 5.00 5.00 0.00 ± 0.20
K+ 3 20 3.22 3.20 -0.02 ± 0.13
4 20 1.97 2.00 0.03 ± 0.08
5 20 1.46 1.40 -0.06 ± 0.06

EC 90 User Manual 182

 ANALYTICAL PERFORMANCE

Table 34

Mean Target Bias Specification

Level N per level
[mmol/L] [mmol/L] [mmol/L] [mmol/L]
1 20 0.50 0.50 0.00 ± 0.05
2 20 1.26 1.25 -0.01 ± 0.06
2+
iCa 3 20 1.63 1.60 -0.03 ± 0.08
4 20 2.38 2.34 -0.04 ± 0.12
5 20 3.79 3.70 -0.09 ± 0.19

Table 35

Mean Target Bias Specification

Level N per level
[mmol/L] [mmol/L] [mmol/L] [mmol/L]
1 20 123.3 124.0 0.7 ± 5.0
2 20 102.4 103.0 0.6 ± 4.1
Cl- 3 20 86.0 86.4 0.4 ± 3.5
4 20 71.0 71.1 0.1 ± 2.8
5 20 60.6 60.8 0.2 ± 2.4

8.2.3 Urine
Accuracy for urine was obtained from measurements of 5 levels of Bio-Rad urine standard material on
EC 90 Electrolyte Analysers. The bias results were calculated by substracting the mean of the
measurement results from the target values of the standard materials.
Table 36

Mean Target Bias Specification

Level N per level
[mmol/L] [mmol/L] [mmol/L] [mmol/L]
1 10 80.9 79.7 -1.2 ± 4.0
2 10 101.8 102.8 1.0 ± 5.1
+
Na 3 10 123.4 125.9 2.5 ± 6.3
4 10 145.2 148.9 3.7 ± 7.4
5 10 171.2 172.0 0.8 ± 8.6

Table 37

Mean Target Bias Specification

Level N per level
[mmol/L] [mmol/L] [mmol/L] [mmol/L]
1 10 31.8 30.4 -1.4 ± 2.2
2 10 41.1 40.1 -1.0 ± 2.8
K+
3 10 50.3 49.5 -0.8 ± 3.5
4 10 59.6 59.4 -0.2 ± 4.2

EC 90 User Manual 183

 ANALYTICAL PERFORMANCE

5 10 67.8 69.0 1.2 ± 4.8

Table 38

Mean Target Bias Specification

Level N per level
[mmol/L] [mmol/L] [mmol/L] [mmol/L]
1 10 100.7 101.0 0.3 ± 6.1
2 10 126.2 128.3 2.1 ± 7.7
-
Cl 3 10 153.3 155.5 2.2 ± 9.3
4 10 180.2 182.8 2.6 ± 11.0
5 10 211.5 210.0 -1.5 ± 12.6

8.3 Linearity

8.3.1 Plasma
Plasma linearity as shown in the follwing table and graphs was calculated from measurements of 11
levels of plasma. Reference values for sodium (Na+), potassium (K+), ionized calcium (iCa2+) and chloride
(Cl-) were obtained using a traditional laboratory electrolyte analyser.
Table 39

Analyte N per level Slope Intercept R2 Range [mmol/L]

+
Na 20 1.007 -2.417 0.999 41 - 374
K+ 20 1.004 0.080 0.999 0.6 - 27
2+
iCa 20 1.056 -0.154 0.999 0.3 - 4.2
Cl- 20 1.100 -6.039 0.999 12 - 315

8.3.1.1 Na+ plasma linearity

Figure 293

EC 90 User Manual 184

 ANALYTICAL PERFORMANCE

8.3.1.2 K+ plasma linearity

Figure 294

8.3.1.3 iCa2+ plasma linearity

Figure 295

EC 90 User Manual 185

 ANALYTICAL PERFORMANCE

8.3.1.4 Cl- plasma linearity

Figure 296

8.3.2 Aqueous
The data from the aqueous solution accuracy in the previous section were used to calculate the
aqueous solution linearity as shown in the following table and graphs.
Table 40

Analyte N per level Slope Intercept R2 Range [mmol/L]

Na+ 20 0.982 0.272 0.998 88 - 180
+
K 20 0.990 0.042 0.999 1.4 - 8.0
iCa2+ 20 1.030 -0.020 0.998 0.5 - 3.7
-
Cl 20 0.990 0.507 0.999 60.8 -124

8.3.2.1 Na+ aqueous linearity

Figure 297

EC 90 User Manual 186

 ANALYTICAL PERFORMANCE

8.3.2.2 K+ aqueous linearity

Figure 298

8.3.2.3 iCa2+ aqueous linearity

Figure 299

EC 90 User Manual 187

 ANALYTICAL PERFORMANCE

8.3.2.4 Cl- aqueous linearity

Figure 300

8.3.3 Urine
Urine linearity as shown in the following table and graphs was calculated from measurements of 9
levels of urine. High levels were prepared by adding salts to the Bio-Rad standard urine material and
low levels were prepared by diluting the reference material, respectively, to expand the tested range.
Table 41

Analyte N per level Slope Intercept R2 Range [mmol/L]

+
Na 10 0.961 3.767 0.999 26 - 420
K+ 10 0.979 1.977 0.999 10 - 180
2+
iCa 10 1.025 -4.496 0.999 33 - 460

8.3.3.1 Na+ urine linearity

Figure 301

EC 90 User Manual 188

 ANALYTICAL PERFORMANCE

8.3.3.2 K+ urine linearity

Figure 302

8.3.3.3 Cl- urine linearity

Figure 303

EC 90 User Manual 189

 ANALYTICAL PERFORMANCE

8.4 Interferences
The following substances were found to significantly interfere with respective measurement
parameters of the instrument.
Table 42

Test Significant interference with

Substance Test matrix
concentration c Na+ c K+ c iCa2+ c Cl-
Magnesium (Mg2+) > 2.2 mmol/L ___ ___
✓ ___
Plasma
> 5.3 mmol/L ___ ___ ___
✓ Plasma
Bromide (Br-)
> 12.0 mmol/L ___ ___ ___ ✓ Urine
___
Iodide (I-) > 3.0 mmol/L ___ ___
✓ Plasma
> 3.9 mmol/L ___ ___ ___
✓ Plasma
Thiocyanate (SCN-)
> 3.6 mmol/L ___ ___ ___
✓ Urine
Hydrogenphosphate (HPO42-) > 34.0 mmol/L ✓ ___ ___ ___
Urine
___ ___
✓ ___
Plasma
pH 6.9 – 7.9 pH units ___ ___
✓ ___
Whole Blood
Citrate > 0.4 mmol/L ___ ___
✓ ___
Plasma
EDTA > 0.5 mmol/L ___ ___
✓ ___
Plasma
Ibuprofen > 5.7 mmol/L ___
✓ ___ ___
Urine

EC 90 User Manual 190

SETUP