Medonic M16C-US Manual de usuario

Art no 1504155 May 2006

Medonic M-series

Contents

PREFACE.................................................................................................................................................. 3

Introduction................................................................................................................................... 3

SECTION 1: SAFETY INSTRUCTIONS ...................................................................................................... 5

Section Overview........................................................................................................................... 5

1.1 Intended Use ............................................................................................................................ 5

1.2 Safety Instruction.................................................................................................................... 6

1.3 Biohazards................................................................................................................................ 6

1.4 Emergency Procedure............................................................................................................. 7

1.5 Warning Signs in Manual....................................................................................................... 7

1.6 Signs on Equipment................................................................................................................. 8

SECTION 2: INSTALLATION .................................................................................................................. 10

Section Overview......................................................................................................................... 10

2.1 Unpacking / Operating Placement & Environment........................................................... 10

2.2 Installation Checklist and Menu......................................................................................... 12

2.3 Analyzer Cable, Interface, and Printer Connections........................................................ 14

2.4 Reagent Installation.............................................................................................................. 15

2.5 Changing Reagents................................................................................................................ 18

2.6 Power Supply........................................................................................................................ 18

SECTION 3: GENERAL OVERVIEW....................................................................................................... 20

Section Overview......................................................................................................................... 20

3.1 General Instrument Overview.............................................................................................. 20

3.2 Menu Structure...................................................................................................................... 21

3.3 System Flow........................................................................................................................... 23

3.4 Sample Volume, Throughput, and Parameters.................................................................. 24

SECTION 4: INSTRUMENT SETUP ......................................................................................................... 25

Section Overview......................................................................................................................... 25

4.1 Menu Selection....................................................................................................................... 25

4.2 Initial Setup............................................................................................................................ 26

4.3 Advanced Setup..................................................................................................................... 27

4.4 Reagent Setup........................................................................................................................ 31

4.5 User Interface ........................................................................................................................ 33

SECTION 5: SAMPLE ANALYSIS............................................................................................................ 36

Section Overview......................................................................................................................... 36

5.1 Preparations before Analysis................................................................................................ 36

5.2 Startup Sequence................................................................................................................... 37

5.3 Background Count................................................................................................................ 39

5.4 Sample Identification............................................................................................................ 39

5.5 Analyzing the Sample (Open Tube)..................................................................................... 40

5.6 Analyzing the Sample (Pre-dilution procedure)................................................................. 42

5.7 Analyzing the Sample (Micro Pipette Adapter, MPA)....................................................... 44

5.8 Analyzing the Sample (Cap Piercing Device)...................................................................... 47

5.9 Analyzing the Sample (Autoloader)..................................................................................... 48

5.10 Results................................................................................................................................... 52

SECTION 6: QUALITY CONTROL (QC) AND BLOOD CONTROL MEMORY........................................ 54

Section Overview......................................................................................................................... 54

6.1 Quality Control (QC)............................................................................................................ 54

6.2 Levey-Jennings Plots............................................................................................................. 56

6.3 Initialization and Use of Xb Function.................................................................................. 58

SECTION 7: CALIBRATION.................................................................................................................... 59

Section Overview......................................................................................................................... 59

7.1 Preparations before calibration........................................................................................... 59

7.2 Calibration............................................................................................................................. 60

SECTION 8: CLEANING,MAINTENANCE &TRANSPORT .................................................................... 64

Section Overview......................................................................................................................... 64

8.1 Daily Cleaning........................................................................................................................ 64

8.2 Monthly Cleaning.................................................................................................................. 65

8.3 Six (6) Month Cleaning......................................................................................................... 66

8.4 Re-location of instrument (within the laboratory) ............................................................. 67

8.5 Short Term Shutdown (<12h) .............................................................................................. 67

8.6 Re-packaging and Long Term Shutdown (>12h)............................................................... 68

8.7 Permanent Shut-Down and Storage .................................................................................... 69

8.8 Disposal Information............................................................................................................. 69

SECTION 9: PARAMETER AND SYSTEM INFORMATION MESSAGES................................................... 70

Section Overview......................................................................................................................... 70

9.1 Out-of-Range and Information Message Indicators .......................................................... 70

9.2 System Information Messages.............................................................................................. 71

9.3 Parameter Limitations of Automated Blood Cell Counters.............................................. 73

SECTION 10: TECHNOLOGY ................................................................................................................. 77

Section Overview......................................................................................................................... 77

10.1 Measuring Principles........................................................................................................... 77

10.2 Counting Time RBC & WBC............................................................................................. 78

10.3 WBC Differentials............................................................................................................... 79

10.4 Photometric Method –HGB Hemoglobin......................................................................... 80

10.5 Parameter Definitions......................................................................................................... 80

SECTION 11: SPECIFICATIONS ............................................................................................................. 82

Section Overview......................................................................................................................... 82

11.1 General................................................................................................................................. 82

11.2 Short List of Specifications................................................................................................. 83

11.3 Parameter Ranges ............................................................................................................... 84

11.4 Reagents and Reagent Consumption................................................................................. 85

SECTION 12: TROUBLESHOOTING ....................................................................................................... 86

Section Overview......................................................................................................................... 86

12.1 Communication Issues ........................................................................................................ 86

12.2 General Information Displays............................................................................................ 88

12.3 Warning Displays................................................................................................................ 93

12.4 Aspiration Issues.................................................................................................................. 98

12.5 Troubleshooting Other Issues ............................................................................................ 99

INDEX................................................................................................................................................. 100

APPENDIX A......................................................................................................................................... 101

APPENDIX B......................................................................................................................................... 107

Preface

Introduction

Instrument

description

Medonic M-Series 3-part hematology analyzer produced by Boule Medical for

human application.

Serial number

Serial number is located on the rear of the instrument.

Figure 1.1

Figure 1.1 Figure 1.2

Software version

The software version is displayed when starting up the instrument.

Instrument

List of models

Product

code

Product name

1400073

M-series M16M US

1400074

M-series M16C-US

1400075

M-series M16S BD ABR US

Additional

Documentation

Additional documentation is available from your authorized distributor.

Current additional documentation is listed below:

User Definable Settings

Operator requirements

The following operator requirements must be fulfilled before operating

the Medonic M-Series hematology system.

Basic skills in a laboratory environment.

Basic skills in hematology.

Awareness of IVD (EU)/FDA (US) requirements regarding laboratory

equipment.

The operator must read and understand this manual.

Optional accessories

and consumables

Accessories and consumable lists are available from your local

distributor.

Manufacturer’s details

Boule Medical AB

Domnarvsgatan 4

SE-16353 Spånga, Sweden

Website: www.medonic.se

Distributor details

Clinical Diagnostic Solutions

1800 NW 65th Ave

Plantation, FL 33313 USA

Toll Free: 1-800-453-3328

Direct: 1-954-791-1773

Fax:1-954-791-7118

Website: www.cdsolinc.com

International

standards and

regulations

SS-EN ISO 18113-3:2011

IVD 98/79/EG

SSEN 61010-2-101 (Low Voltage Directive 2006/95/EC)

EN 61326 (2006) (EMC 2004/108/EC)

2012/19/EU WEEE

Standards harmonized with FDA

Date of Issue

February 2016 Article no: 1504472

Software version

Firmware 2.9.4

Third-party Software

For information see Appendix B.

Section 1: Safety Instructions

Section Overview

Introduction

This section describes the safety features and warnings associated with the

Medonic M-Series.

Contents

This section contains the following topics:

Topic

See Page

Intended Use

Safety Instructions

Biohazards

Emergency Procedures

Warning Signs in Manual

Signs on Equipment

1.1 Intended Use

Description

The Medonic M-Series is a fully automatic hematology analyzer intended for

in vitro diagnostic testing of human blood samples under laboratory

conditions.

Operator

Requirements

Operator must have basic laboratory skills and be aware of good laboratory

practice.

Warranty

limitations

Service must be performed by Boule Medical AB (hereafter referred to as

Boule), CDS or by service personnel authorized by Boule.

Use only original spare parts and Boule authorized reagents, controls,

calibrators and cleaners. (If these products are substituted it may void your

warranty)

Operators and laboratory supervisors are responsible that Boule products are

operated and maintained according to the procedures described in manuals,

control inserts and technical bulletins.

Warranty

limitations in

depth

Each Boule system is tested using recommended reagents, controls,

calibrators and cleaners. All performance claims are generated as part of this

complete system.

Boule products do NOT make diagnoses on patients. Boule intends its

diagnostic products (systems, software and hardware) to be used to collect

data reflecting the patient’s hematological status. This data, in conjunction

with other diagnostic information and the evaluation of the patient’s

condition, can be used by a trained clinician to establish a patient’s diagnosis

and to define clinical treatment.

1.2 Safety Instruction

Description

Boule incorporates safety features within the instrument in order to protect the

operator from injury, the instrument from damage and the test results from

inaccuracies.

Restrictions

In order to insure the safety of the operator and instrument follow the

instruction below:

Do not use the instrument outdoors.

Do no modify the instrument.

Do not remove the cover. (Authorized personnel only)

Do not use the instrument for other purposes than described in this manual.

Do not spill blood or other fluids on the instrument in such a way that it can

leak through the instrument casing. (This might result in electrical

malfunction or personal injury)

Do not drop or place objects on the analyzer.

Do not use this device in close proximity to source of strong electromagnetic

radiation (e.g. unshielded international RF sources), as these can interfere

with the proper operation.

Do not use power supply other than supplied by your local distributor.

Important

Unauthorized modification of the instrument might result in erroneous

results or risk for electrical shock.

Spilling fluids into the instrument might cause electrical malfunction and/or

personal injury.

Handling of

reagents

If a reagent comes in contact with eyes, rinse with running water for several

minutes. If symptoms occur seek medical attention.

If the reagent comes into contact with skin, wash affected area with water.

If swallowed, rinse out mouth. If persistent symptoms occur seek medical

attention.

Refer to MSDS at www.cdsolinc.com for further details.

SDS Sheets are available for all reagents.

1.3 Biohazards

Description

As there are no assurances of the absence of HIV, Hepatitis B or C viruses or

other infectious agents in blood samples, controls, calibrators and waste these

products should be handled as potentially biohazardous.

Support

documentation

Protection of Laboratory Workers From Infectious Disease Transmitted by

occupationally acquired infections –2nd Edition, Approved Guidelines

(2001) Document M29-T2 promulgated by the Clinical and Laboratory

Standards Institute, CLSI (NCCLS).

Follow local regulatory documentation.

Handling of

biohazardous

material

Use universal precautions when handling samples and discarding waste.

Handle any exposure according to established laboratory protocol

regulations.

The instructions for analyzer decontamination and disposal can be found on

the Medonic home page, www.medonic.se under support.

1.4 Emergency Procedure

In case of

emergency

If there are any obvious signs of malfunction such as smoke or liquid leaking

out of the instrument proceed as follows:

Step

Action

Disconnect the main power supply immediately by pulling out the

cord from the main supply.

Contact your authorized distributor.

1.5 Warning Signs in Manual

Warning Signs

The following warning signs in the manual are used to identify possible

hazards and to call on the operator’s attention to this condition.

Sign

Function

Warning

Indicates operation procedures that could result

in personal injury if not correctly followed.

Caution

Indicates operation procedures that could result

in damage or destruction of equipment if not

strictly observed.

Important

Emphasizes operating procedures that must be

followed to avoid erroneous results.

Mandatory Action

Indicates that protective clothing, gloves or gog-

gles must be used when performing described

procedures.

1.6 Signs on Equipment

Description

Signs placed on the instrument define areas that need special attention or areas

that contain danger. See IVD Symbol Table on page 9.

Signs on equipment

Figure 1.3 Figure 1.4

Figure 1.5 Figure 1.6

Batch code

Serial number

Catalogue number

Manufacturer

Authorised*

Representative in the

European Community

Biological Risks

Fragile, handle with

care

Use by

In vitro diagnostic

medical device

Lower limit of

temperature

Upper limit of

temperature

Temperature

limitation

CONTROL L 16

CONTROL N 16

Consult instructions

for use

Control

Low control, 16

parameters

Normal control, 16

parameters

CONTROL H 16

CAL

CONT

High control, 16

parameters

Calibrator

Content

Recycling

WEEE

Figure 1.7 IVD Symbol Table

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