Dr.Muller SUPER GL easy Bedienungsanleitung

Instructions for use

SUPER GL easy

SUPER GL easy+

Valid from Version: 3.23

Effective from August, 2012

Manufacturer / Copyright:

Dr. Müller Gerätebau GmbH

Burgker Str. 133

D – 01705 Freital

Distributor:

Service – Hotline:

Monday – Friday from 7 a.m. until 6 p.m.

If you have any questions concerning our products or would like to

place an order, please contact:

+49 (0)351 649 12 93

+49 (0)351 64 50 42

Or contact us via:

Fax: +49 (0)351 649 15 04

Email: supp[email protected] or info@glukose.de

You will find the current version of this manual on our website

www.glukose.de

Contents

20.08.2012 Page 2 of 42 Rev. 04

A) Contents

Page Rev.

A Contents 2 04

B List of illustrations 4 04

C List of symbols 5 04

1 Preface 6 04

1.1 Introduction 6 04

1.2 The SUPER GL easy / SUPER GL easy+ 6 04

1.2.1 Basic matters 7 04

1.2.2 Equipment and accessories 8 04

1.2.3 Overview of functions 8 04

1.3 Indication / Contraindication 9 04

1.4 Manufacturer's liability 9 04

1.5 Warranty 9 04

2 Safety 10 04

2.1 Introduction 10 04

2.2 Responsibility / Training of user 10 04

2.3 General safety instructions 10 04

2.4 Product-specific safety instructions 11 04

2.5 Maintenance interval 11 04

3 Description of the analyser 12 04

3.1 Introduction 12 04

3.2 Purpose 12 04

3.3 Measuring principle 13 04

3.3.1 Measuring principle glucose / lactate determination 13 04

3.3.2 Measuring principle hemoglobin determination 15 04

3.3.3 Displaying plasma reference glucose values 16 04

3.4 Structure and appearance 16 04

3.5 Accessories 16 04

3.6 Consumables 17 04

4 Operation - Part 1 18 04

4.1 Introduction 18 04

4.2 Safety instructions 18 04

4.3 Installing the equipment 19 04

4.4 Setting up the equipment 20 04

4.5 Preparing of measuring process 23 04

4.5.1 General 23 04

4.5.2 Sample preparation 24 04

4.6 Measuring operation 26 04

4.6.1 Calibration 26 04

4.6.2 Patient sample 26 04

4.6.3 Measure samples with bar code 27 04

4.6.4 Active controls 27 04

4.7 Method 27 04

4.8 Printer settings 28 04

4.9 Switching off the equipment 28 04

Contents

20.08.2012 Page 3 of 42 Rev. 04

5 Operation - Part 2 29 04

5.1 Introduction 29 04

5.2 Menu functions 29 04

5.2.1 Stand by / „Measurement Menue“ 29 04

5.2.2 Stand by / “Function Menue” 29 04

5.2.2.1 Calibration 30 04

5.2.2.2 Display results 30 04

5.2.2.3 Delete results 30 04

5.2.2.4 Copy results 30 04

5.2.2.5 Output results 30 04

5.2.2.6 Washing 31 04

5.2.2.7 Set time 31 04

5.2.2.8 Plasma reference glucose 31 04

5.3 Functions when switching on device 31 04

5.4 DIL switch settings 33 04

5.5 Functions of the cards 34 04

5.6 Quality control 35 04

6 Maintenance and troubleshooting 36 04

6.1 Introduction 36 04

6.2 Maintenance 36 04

6.3 Servicing 36 04

6.3.1 Cleaning and disinfection 36 04

6.3.2 Change of sensor 37 04

6.3.3 Change of containerkit 37 04

6.3.4 Change of pump head 38 04

6.3.5 Taking equipment out of operation 39 04

6.3.6 Prepare equipment for transport 39 04

6.4 Reporting and repairing faults 40 04

6.4.1 Warnings 40 04

6.4.2 Measurement errors 40 04

6.4.3 Equipment errors 41 04

6.4.4 Measuring errors 41 04

7 Technical data 42 04

List of illustrations

20.08.2012 Page 4 of 42 Rev. 04

B) List of illustrations

Page Rev.

General view SUPER GL easy / easy+ Fig. 1.1 6 04

View of equipment Fig. 1.2 8 04

Accessories Fig. 1.3 8 04

Flow chart Type SUPER GL easy Fig. 3.1 13 04

Flow chart Type SUPER GL easy+ Fig. 3.2 13 04

Diagram of measuring principle Fig. 3.3 14 04

Reactions in glucose sensor Fig. 3.4 14 04

Reactions in lactate sensor Fig. 3.5 14 04

Flow chart photometer Fig. 3.6 15 04

View of equipment Fig. 3.7 16 04

Accessories Fig. 3.8 16 04

View of connector panel Fig. 4.1 20 04

Menu structure Fig. 4.2 22 04

Sample preparation using open-end capillary Fig. 4.3 25 04

DIL - switch Fig. 5.1 33 04

Sensor holder closed Fig. 6.1 37 04

Sensor holder open Fig. 6.2 37 04

Connection containerkit Fig. 6.3 38 04

View of pump head Fig. 6.4 38 04

Pump head Fig. 6.5 38 04

Table of errors while measuring Fig. 6.7 40 04

List of technical data Fig. 7.1 42 04

List of symbols

20.08.2012 Page 5 of 42 Rev. 04

C) List of symbols

Symbols on the equipment

Symbol

Description

Biohazard

Enter - key for selecting a menu item or changing the

menu area

Menu button for selecting menu items

Follow instructions for use

IVD

in vitro diagnostics

Manufacturer

CE - conformity

serial number

Symbols on consumables

Symbol

Description

Biohazard

IVD

in vitro diagnostics

CE - conformity

read accompanying documents

Follow instructions for use

Recyclable material

Dispose of correctly

Storage temperature

REF

Item number

Cont.

Contents of package

LOT

Batch number

Use by

Symbols in instruction manual

Symbol

Description

Attention or Note

Bold/italics

Very important notes

* Explanation of terms: Authorized people are people who have gained expert

knowledge by completing training courses offered by the manufacturer or

authorized companies.

Preface

20.08.2012 Page 6 of 42 Rev. 04

1 Preface

1.1 Introduction

Congratulations on purchasing the SUPER GL easy / easy+ analyser. We hope you

will find working with your analyser satisfying and successful.

In the following chapter "The SUPER GL easy / easy+" you will find a first

overview of your analyser: what parameters you can measure, what further

devices and accessories belong to your analyser, and an overview of the device's

functionality.

Furthermore, you will receive information on safety, on liability and warranty, and

on indications or contraindications of your analyser.

For further and more detailed information, please read the corresponding

chapters.

1.2 The SUPER GL easy / SUPER GL easy+

The SUPER GL easy / easy+ analyser is a device for biochemical analysis in in-

vitro diagnostics. The device is an analyser for determination of glucose and / or

lactate respectively for determination of glucose and / or lactate and / or

hemoglobin.

Fig. 1.1 General view SUPER GL easy / easy+

 depending on sensor type

 depending on model of equipment

Preface

20.08.2012 Page 7 of 42 Rev. 04

1.2.1 Basic matters

The SUPER GL easy / easy+ was developed with the use of modern technical

resources, associated with decades of experience in the field of clinical-chemical

analyser production.

In construction and manufacture it fulfils all the legal EU regulations pertaining to

equipment for use in in-vitro diagnostics. Application of the CE mark clearly

documents compliance with the applicable standards and laws. The CE mark

means the product complies with the law and standards and ensures safety and

reliability for you and your patients.

Through the use of a sensor for high quality determination of glucose and/or

lactate and a photometer for determining hemoglobin, it is possible to fulfil all the

quality assurance requirements (e.g. the RiLiBÄK in Germany) prescribed for its

field of use with the simplest handling and lowest maintenance and operating

costs. This means that all users are able to achieve analysis results which meet

the quality requirements for professional measurements.

 depending on sensor type

 depending on model of equipment

Preface

20.08.2012 Page 8 of 42 Rev. 04

1.2.2 Equipment and accessories

Range:

Description Quantity

SUPER GL easy / SUPER GL easy+ 1

Mains cable 1

Power supply unit for equipment and printer 1

Instructions for use 1

Optional

Printer DPU 414 1

Printer cable 1

EDP cable 1

Fig. 1.2 View of equipment Fig. 1.3 Accessories

1.2.3 Overview of functios

The SUPER GL easy / easy+ analyser is an automatic analyser for the

determination of glucose and / or lactate and / or hemoglobin in 1+50 pre-

diluted samples, e.g. in hemolysed blood samples.

The device measures by using the sample position at the sample rotor single

samples or control samples. The results of measurement will be showed at the

display and will be printed out and also could be sended at EDP.

You can find further information in the relevant chapters on the measuring

principle and on obtaining samples.

 depending on sensor type

 depending on model of equipment

Preface

20.08.2012 Page 9 of 42 Rev. 04

1.3 Indication / Contraindication

Indication

The SUPER GL easy / easy+ analyser determines glucose and / or lactate and /

or hemoglobin in human sample material and supplies measurement values for

the diagnosis and treatment of diabetes.

Possible sample material can include:

- capillary or venous or arterial blood

- serum (not for hemoglobin)

- plasma (not for hemoglobin)

- cerebro-spinal fluid (not for hemoglobin)

- for more materials ask the manufacturer

The blood taken should contain the following anticoagulants / glycolysis inhibitors:

heparin, citrate, fluoride, EDTA.

Contraindication

The use of incorrect sample materials can lead to incorrect readings. Please call

the manufacturer if you are in doubt.

Operating the device for home testing is expressly

forbidden!

1.4 Manufacturer’s liability

Legal liability and claims under the guarantee or warranty are expressly excluded

in the following cases:

- Grossly negligent or wilful damage to the equipment, parts or consumable

materials

- Unauthorised opening of the analyser by untrained staff (without service

training)

- Force majeure (e.g. lightning strike, water damage, fire)

- Non-observance of the instructions for use and package inserts

1.5 Guarantee

Dr. Müller Gerätebau GmbH guarantees its products to the purchaser in

accordance with Directive 1999/44/EC for a period of two years from the purchase

date. Consumable materials (because of their short shelf-life) and wear and tear

of parts are expressly excepted from this as these should be changed annually

during servicing. Please find further details of replacement parts and consumables

in the relevant chapter.

 depending on sensor type

 depending on model of equipment

Safety

20.08.2012 Page 10 of 42 Rev. 04

2 Safety

2.1 Introduction

The following chapters deal with the safety of people working on the equipment.

Please read these chapters carefully BEFORE operating the equipment as they

contain the general safety instructions and information on the personal protection

of people working on the equipment and also on the protection of the equipment.

The installation of the following safety instructions

does not release the equipment user from the duty

to observe other relevant safety measures which

apply to all equipment.

2.2 Responsibility / Training of user

- The SUPER GL easy / easy+ provides measured values for the diagnosis

and treatment of diabetes.

- Use for personal use is expressly forbidden.

- An introduction to the correct use of the equipment can be given by a

member of staff from the manufacturer or authorised sales partner in

agreement with the persons working on the equipment.

- Each user is responsible for observing the safety, health and legal

regulations and for using the equipment in the proper manner only.

- Evaluation of the results and the diagnostic and therapeutic measures

derived from them must be carried out only by specialist staff authorised to

do so.

2.3 General safety instructions

- Before use of the equipment, please read all the instructions for use –

carefully, especially the regulations on taking samples –.The manufacturer’s

staff or the authorised sales company are available to answer any

questions.

- All persons working on the equipment must be made aware of the relevant

safety regulations before use and these must be kept ready to hand at all

times.

- Please note all the general safety regulations for your area of application,

such as the wearing of protective gloves and the relevant disinfection and

hygiene regulations.

- If there is any accidental skin contact with potentially infectious substances,

e.g. human samples, disinfect the affected parts of the body with a suitable

disinfectant solution.

- The haemolysis system solution is not corrosive, poisonous or seriously

harmful to skin. If there is any skin contact with the haemolysis system

solution or the calibration solution, rinsing with water is sufficient. You can

find more information on this in the safety data sheet for each solution.

Dieses Handbuch passt für folgende Modelle

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