NextStart 2.0.95 serial key or number

User Manual
Ref:

Int. Ref. Doc.: RABEEN

User Manual
Ref: - Int. Ref. Doc.: RABEEN
Contents

Foreword
1. Document Update 6

2. Legal Information

Introduction 11
1. Warning and Precautions 12

2. Operational Conditions 16

3. Instrument Overview 21

4. Labels and Connections 23

5. Printer

Specifications
1. Technical Specifications

2. Physical Specifications 38

3. Reagent Specifications 40

4. Analysis Specifications 42

5. Limitations 43

Software 45
1. Software Overview 46

2. Menus Description 47

3. Software Buttons Description 50

4. Using the Software

Quality Assurance 61
1. Quality Control Overview

User Manual i
Ref: - Int. Ref. Doc.: RABEEN
 2. Quality Control by Control 63

3. Quality Control by Test

4. Westgard Rules 82

5. Logs

6. Test Counter (On Request) 92

Workflow
1. Sample Materials

2. Workflow Overview

3. Start of Day

4. Reagent Status

5. Calibration and Control

6. Patient Samples

7. Common Tasks in a Working Day

8. End of Day

Settings
1. Reagent Management

2. Calibration and Control Configuration

3. Application Configuration

4. System Configuration

Maintenance and Troubleshooting

2. Maintenance

3. Troubleshooting

ii User Manual
Ref: - Int. Ref. Doc.: RABEEN
Alarms
1. System Warnings and Alarms

2. Sampling Alarms

3. Analytical and Quality Flags

4. ISE Error Codes

Description and Technology

2. Data Analysis

User Manual iii

1. Document Update 6
Revisions
What's New?

2. Legal Information
Declaration of Conformity 8
Notice of Liability
Trademarks 8
Graphics
Document Symbols
Typographical Conventions 9
Copyright © by HORIBA ABX SAS 10

User Manual 5
Ref: - Int. Ref. Doc.: RABEEN
Foreword
Document Update

1. Document Update

Revisions

Reference Internal Reference Software Version Document Date Issued

This document applies to the latest software version listed and higher versions.
When a subsequent software version changes the information in this document, a new electronic
edition (USB flash drive and/or online help) is released and supplied by HORIBA Medical.
To update a paper document, please contact your local HORIBA Medical representative.

Documentation instructions (USB flash drive)

What's New?

Here is the list of major updates in this document release:

Software Version X

Item Description Chapter

6 User Manual
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 Foreword
Document Update

User Manual Corrections and Additions

Item Description Chapter

User Manual 7
Ref: - Int. Ref. Doc.: RABEEN
Foreword
Legal Information

2. Legal Information

Declaration of Conformity

This product complies with the Standards and Directives named in the Declaration of Conformity.
The latest version of the EC Declaration of Conformity for this product is available on manicapital.com-
manicapital.com

Notice of Liability

The information in this manual is distributed on an "As Is" basis, without warranty. While every
precaution has been taken in the preparation of this manual, HORIBA Medical will not assume any
liability to any persons or entities with respect to loss or damage, caused or alleged to be caused
directly or indirectly by not following the instructions contained in this manual, or by using the
computer software and hardware products described herein in a manner inconsistent with our
product labelling.

Trademarks

Microsoft and Windows are registered trademarks of Microsoft Corporation.

Graphics

All graphics including screens, printouts and photographs are for illustration purposes only and are
not contractual.

8 User Manual
Ref: - Int. Ref. Doc.: RABEEN
 Foreword
Legal Information

Document Symbols

To alert the operator of potentially hazardous conditions, symbols described in this chapter are
provided wherever necessary throughout the manual.

Emphasizes information that must be followed to avoid hazard to either the operator or the
environment, or both.

Emphasizes information that must be followed to avoid possible damage to the instrument
or erroneous test results.

Emphasizes information that can be helpful to the operator before, during or after a
specific operational function.

Gives a summary of what can be achieved if the task is performed.

Typographical Conventions

Before you start using this documentation, you should become familiar with the following
typographical conventions.
Indicates, from the main screen, the
sequence of menus you have to go
through to begin the procedure.

Indicates, from the main screen, the

Used for interface items (buttons,

Used for windows titles, dialog boxes

External links can be used to retrieve

User Manual 9
Ref: - Int. Ref. Doc.: RABEEN
Foreword
Legal Information

Internal links can be used when

The Related information box provides

Copyright © by HORIBA ABX SAS

All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written
permission of HORIBA Medical.

HORIBA ABX SAS

10 User Manual
Ref: - Int. Ref. Doc.: RABEEN
 Introduction

1. Warning and Precautions 12

2. Operational Conditions 16
Environment 16
Location 16
Grounding 17
Humidity and Temperature Conditions 17
Electromagnetic Environment Check
Main Power Supply 18
Environmental Protection
Storage Conditions and Transportation
Installation 19
Package 20

3. Instrument Overview 21

4. Labels and Connections 23

5. Printer

User Manual 11
Ref: - Int. Ref. Doc.: RABEEN
Introduction
Warning and Precautions

1. Warning and Precautions

Work safety reliability and general characteristics are guaranteed by HORIBA Medical under the
following conditions:
■ User manual must be entirely read, and personnel trained by a HORIBA Medical representative
before attempting to operate the instrument.
■ The user always operates with full knowledge and appreciation of instrument warnings and alarms.
■ Always refer to labelling and HORIBA Medical instructions in order to avoid compromising system
integrity.
This instrument must be operated as instructed in the user manual. Any other use might compromise
system integrity and might be hazardous for the operator.
This instrument complies with Standards and Directives named in the Declaration of Conformity. The
latest version of the Declaration of Conformity for this instrument is available online at manicapital.com-
manicapital.com

■ The reagents and accessories stipulated by HORIBA Medical have been validated in
accordance with the European Directive for in vitro medical devices (98/79/EC).
■ The use of any other reagents and accessories may place the performance of the
instrument at risk, thus engaging user responsibility. In this case, HORIBA Medical
takes no responsibility for the device nor for the results rendered.
■ Disposable gloves, eye protection and lab coat must be worn by the operator.
■ Local or national regulations must be applied in all the operations.
■ Mobile phones should not be used in proximity of the instrument.
■ All peripheral devices should comply with relevant standards.

Limited Warranty

The duration of warranty is stipulated in the Sales conditions associated with the purchase of this
instrument. To validate the warranty, ensure the following is adhered to:
■ The system is operated under the instructions of this manual.
■ Only software or hardware specified by HORIBA Medical is installed on the instrument. This
software must be the original copyright version.
■ Services must be done by recommendation from HORIBA Medical, provided by an authorized
technician using only approved spare parts and at least once per year or more, depending on the
number of samples.
■ The electrical supply of the laboratory adheres to national or international regulations.
■ The system is operated according to HORIBA Medical recommendations.
■ Specimens are collected and stored in normal conditions.
■ Reagents used are those specified or recommended by HORIBA Medical.
■ Proper tools are used when maintenance or troubleshooting operations are performed.

If this instrument has been supplied to you by anyone other than HORIBA Medical or an
authorized representative, HORIBA Medical cannot guarantee this product in terms of
specification, latest revision and latest documentation. Further information may be
obtained from your authorized representative.

12 User Manual
Ref: - Int. Ref. Doc.: RABEEN
 Introduction
Warning and Precautions

Safety Precautions

Electronic and Moving Parts

The following parts must not be handled or checked by the user:

Operator injury may occur from an electric shock. Electronic components can shock and
injure the user. Do not dismantle the instrument nor remove any components (covers,
doors, panels, etc.) unless otherwise instructed within this document.
Danger of explosion if battery is not replaced correctly! When replacing the battery, always
use the same and/or equivalent type recommended by the manufacturer. Dispose of used
batteries according to the manufacturer specific instructions.

Moving parts: It is strictly forbidden to disable sensors as it may cause operator injuries.
Protection covers must not be opened during instrument operations. Opening the doors
and covers during instrument operations triggers the instrument emergency stop.

Biological Hazard

Consider all specimens, reagents, calibrators, controls, etc. that contain human
specimen extracts as potentially infectious! Use established, good laboratory working
practices when handling specimens. Wear protective gear, gloves, lab coats, safety
glasses and/or face shields, and follow other biosafety practices as specified in OSHA
Blood borne Pathogens Rule (29 CFR part ) or equivalent biosafety
procedures.

All accessible surfaces of the instrument can be potentially contaminated by human

The manufacturer uses disinfectant products for instrument decontamination and highly recommends
it to decontaminate your instrument. Refer to the Maintenance and Troubleshooting > Maintenance >
Other Procedures > To Decontaminate your Instrument chapter to perform the instrument cleaning
and decontamination procedure.

Related information:
■ To Decontaminate your Instrument, p

User Manual 13
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Introduction
Warning and Precautions

Graphics and Symbols

Switch off position Switch on position

Alternating current Manufacturer

This product conforms to the EC

Caution, consult accompanying

Laser Electrostatic sensitive device

Pinch point! Be careful not to

This product should be disposed of and

Notice of environment-friendly
Up
use period

Fragile, handle with care Keep dry

Do not stack Temperature limitation

14 User Manual
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 Introduction
Warning and Precautions

Batch code Reference Number

Use by Install before

Reagent Buffer

Calibrator Control

Content Single use only

Consult Instruction for Use Packaging recycling mark

Green Dot: participation in RESY: cardboard recycling symbol in

ERP (Enterprise Resource

User Manual 15
Ref: - Int. Ref. Doc.: RABEEN
Introduction
Operational Conditions

2. Operational Conditions

Environment

The operation of the Pentra C should be restricted to indoor location use only.
The instrument is operational at an altitude of maximum m ( ft).
The instrument is designed for safety from voltage surges according to INSTALLATION CATEGORY II
and POLLUTION DEGREE 2 (IEC ).
Please contact your local representative for information regarding operation locations when it does
not comply with the recommended specifications.

Location

Keep in mind that the instrument weighs approximately kg ( lb).
To move the instrument, four persons are required.
The lifting handles provided in the installation kit must be used.

■ Place your instrument on a clean and leveled table or workbench.

16 User Manual
Ref: - Int. Ref. Doc.: RABEEN
 Introduction
Operational Conditions

The Power switch and Power supply connection should always be accessible. When
positioning the system for operational use, leave the required amount of space for easy
access to these items.

Grounding

Proper grounding is required when installing the system. Check the wall outlet ground (earth) for
proper grounding to the facilities electrical ground. If you are unsure about the outlet grounding,
contact your facilities engineer to verify the proper outlet ground.

Humidity and Temperature Conditions

Instrument operating temperature: from +15°C (+59°F) to +32°C (+90°F). If the instrument is stored
at a temperature lower than +10°C (+50°F), it should stand for one hour at normal room temperature
before use.
Humidity Conditions: Relative humidity of 20% - 85% maximum, without condensation.
Temperature gradient: 2°C (°F) per hour.

Electromagnetic Environment Check

The instrument has been designed to produce less than the accepted level of electromagnetic
interference in order to operate in conformity with its destination, allowing the correct operation of
other instruments also in conformity with their destination.
In case of suspected electromagnetic noise, make sure that the instrument has not been placed in the
proximity of electromagnetic fields or short wave emissions, e.g. Radar, X-rays, Scanners, Cell
phones, etc.

Do not perform analysis while cover is open or not correctly fixed. Electromagnetic noise
can affect the data or disrupt a nearby instrument.

User Manual 17
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Introduction
Operational Conditions

Main Power Supply

It is recommended to install the system on UPS (Uninterruptible Power Supply).

Grounding is required. Make sure the earth wall-plug is correctly connected to the laboratory
grounding system. If there is no such system, a ground stake should be used.
Use only the main supply cable delivered with the instrument.
Main power supply voltage fluctuations must not exceed +/- 10% of the nominal voltage.

■ Always disconnect the system from the supply before servicing.

Environmental Protection

Used Accessories and Consumables Disposal

Instrument Disposal
This product should be disposed of and recycled at the end of the useful life in
accordance with European Directive /96/EC on Waste Electrical and Electronic
Equipment (WEEE) and/or European Directive /66/EC on batteries and
accumulators.

If any doubt, please contact your local representative.

Storage Conditions and Transportation

Instrument storage and transportation temperatures: from °C (-4°F) to +50°C (+°F).
Analyzer exposure to rainfall and extended sunlight must be avoided. The outdoors storage of the
analyzer is prohibited.

18 User Manual
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 Introduction
Operational Conditions

Before the shipping of an instrument by transporter, whatever the destination, an

Keep in mind that the instrument weighs approximately kg ( lb).
To move the instrument, four persons are required.
The lifting handles provided in the installation kit must be used.

Before instrument removal from use, transportation or disposal, perform a general cleaning and a
draining of your instrument.

Related information:
■ To Decontaminate your Instrument, p

Installation

A representative will install your instrument, printer and software.

The cooling unit will be installed with your instrument.

For further information about the cooling unit, refer to the cooling unit manual.

Package content:
■ Pentra C with or without ISE module (option)
■ Cooling unit
■ Ethylene glycol 2 x 1 L
■ Keyboard (for computer connection)
■ Power supply cable
■ Power strip
■ Software version USB flash drive
■ Reagent Application USB flash drive
■ Documentation USB flash drive
■ Safety Information booklet
■ Installation kit
■ Accessory kit
■ Printer
■ Lifting handles
■ Waste tank
■ Water tank
■ External sample cover

User Manual 19
Ref: - Int. Ref. Doc.: RABEEN
Introduction
Operational Conditions

Only HORIBA Medical approved accessories should be used with the Pentra C

Package

Factory package of the analyzer Pentra C and its implements consists of firm corrugated
cardboard, polyethylene foil and inner foam plastic framework. Package protects analyzer and its
implements from adverse factors of outside environment.

20 User Manual
Ref: - Int. Ref. Doc.: RABEEN
 Introduction
Instrument Overview

3. Instrument Overview

The Pentra C includes several parts.

User Manual 21
Ref: - Int. Ref. Doc.: RABEEN
Introduction
Instrument Overview

1 = ISE module

2 = Sample tray

3 = Reagent tray

4 = Sampling system

5 = Mixer

6 = Cuvette changer

7 = Computer connections

8 = Reaction tray

22 User Manual
Ref: - Int. Ref. Doc.: RABEEN
 Introduction
Labels and Connections

4. Labels and Connections

Serial Number Label

The serial label is located at the back of the instrument.

Power Supply Connection

The Power switch and Power supply connection should always be accessible. When
positioning the system for operational use, leave the required amount of space for easy
access to these items.

The main power switch is located at the back of the instrument.

User Manual 23
Ref: - Int. Ref. Doc.: RABEEN
Introduction
Labels and Connections

1 = Power supply connector

Related information:
■ Analyzer Power Problems, p

Fluidic System Connections

1 = Distilled water input

Condensation water evacuation is made by gravity. Make sure that the tube goes
downward and never upward, and that it does not bend.

24 User Manual
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 Introduction
Labels and Connections

Condensation water evacuation

Dispose of waste according to your local/national guidelines for biohazard waste disposal.

Peripherals Connections

1 = Printer connection (parallel port) until the CCCN () computer reference
2 = Host connection

Since the computer reference, the printer should be connected into a USB
port.

Host connection must be set up by an authorized technician.

User Manual 25
Ref: - Int. Ref. Doc.: RABEEN
Introduction
Labels and Connections

Computer connections until the CCCN () computer reference

3 = VGA

4 = Mouse

5 = Keyboard

6 = LAN (Local Area Network)

7 = USB

8 = Loudspeaker

Computer connections since the computer reference

3 = USB

4 = LAN (Local Area Network)

5 = USB

6 = Loudspeaker

26 User Manual
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 Introduction
Labels and Connections

Warnings and Biological Hazards Labels

Warning! Biological hazard

On the cuvette changer

Near waste outputs

On the waste tank

Caution, consult accompanying documents

Back of the instrument

Near waste outputs

User Manual 27
Ref: - Int. Ref. Doc.: RABEEN
Introduction
Labels and Connections

On the reagent tray cover inside the instrument

Pinch point! Risk to trap hands / fingers

On the reagent tray cover inside the instrument

On the cuvette changer

On the reaction tray inner door

Warning! Electrostatic Sensitive Device (ESD)

On the needles

28 User Manual
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 Introduction
Labels and Connections

Warning! Hot surface

Near the spectrophotometer lamp inside the instrument

Caution - Class 2 laser radiation

On the sample tray cover

On the reagent tray cover inside the instrument

To minimize environmental interferences, the ISE module cover must always be

On the ISE module inside the instrument

User Manual 29
Ref: - Int. Ref. Doc.: RABEEN
Introduction
Labels and Connections

Cassette and Rack Labels

Reagent cassette labels

1 = Barcode label
location

2 = mm

Barcode label location

Reagent rack labels

3 = Reagent rack

4 = Calibrator reagent rack

5 = Control reagent rack

Refer to the Maintenance and Troubleshooting > Maintenance > Consumables and Spare Parts
chapter for rack labels references.

Sample rack labels

30 User Manual
Ref: - Int. Ref. Doc.: RABEEN
 Introduction
Labels and Connections

6 = Sample rack

7 = Sample cup rack

8 = Calibrator sample rack

9 = Control sample rack

Refer to the Maintenance and Troubleshooting > Maintenance > Consumables and Spare Parts
chapter for rack labels references.

You should preferably use the sample rack labels from HAX () to
HAX (). Nevertheless, if you use the 2 of 5 interleaved barcode type
without check digit, you must use the sample rack labels from HAX () to
HAX ().

Reagent and calibrator/control stickers

10 = Reagent stickers

11 = Control stickers

12 = Calibrator stickers

Related information:
■ Consumables and Spare Parts, p
■ To Register a Reagent, p

User Manual 31
Ref: - Int. Ref. Doc.: RABEEN
Introduction
Printer

5. Printer

Use the printer supplied or approved by HORIBA Medical.

Contact your local HORIBA Medical representative for more information about printer
compatibility and consumable part numbers.

32 User Manual

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Na'Mo Name: NAMO s/n: N
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Namo WebEditor Name: Pius Sodipe Sodipe Company: HERiTAGE s/n:
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KKMI4KMKHK5KHJ53I5I5IMJIHJ59ILJKJ6IL4KI6 or RegNet:
KKMI4KMKHK5KHJ53I5I5IMJIHJ59ILJKJ6IL4KI6 For the serial
enter anything between and
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Navarasa Multimedia Name: TeaM LAXiTY Company: LAXiTY s/n: NAV-
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Basic: Pro: or Pro:
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Net Demon s/n:
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