Dr.Muller SUPER GL easy User manual

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:
[phone]
[phone]
Or contact us via:
Fax: [phone]
Email: supp[email protected] or [e-mail]
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
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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
SN
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
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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
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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.