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
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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
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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.

Safety
20.08.2012 Page 11 of 42 Rev. 04
- To avoid the risk of electric shock, do not place either the equipment or the
power supply unit in water or other liquids. If the cable or power supply
unit are damaged in any way, the power supply unit should no longer be
used. Never touch the power supply unit plug with wet hands. The power
supply unit should only be used in closed, dry spaces and must be
protected from damp.
2.4 Product-specific safety instructions
- The equipment should only be used in accordance with the described
indication and the defined bans and restrictions on use must be adhered to
(contact the manufacturer if necessary).
- The equipment should only be operated when standing on a level,
horizontal surface. Wide temperature fluctuations and draughts, direct
sunlight or vibrations should be avoided as they can lead to faulty readings.
- We expressly point out that if the equipment is incorrectly used the
intended protection measures for the analyser may be ineffective.
- Stop working immediately if there is a fault! Before further use of the
equipment, note the instructions on cleaning and on reporting and
remedying faults. After consultation with the manufacturer or the relevant
authorised sales company, it may be necessary to send the equipment to
the manufacturer or authorised sales company for repair.
- Use only original accessories and replacement parts to avoid damage to
equipment and persons. Repair work should only be carried out by the
manufacturer or companies authorised by the manufacturer.
- The use of reagents and consumables not expressly recommended by the
manufacturer may lead to serious reading and functional faults and is
therefore not approved.
- If the equipment is opened by the user without authorisation, liability for
the equipment and any damage caused by this is excluded.
2.5 Maintenance intervals
The SUPER GL easy / easy+ needs servicing once a year by assigned specialist
staff. A warning will appear on the screen once the service interval has elapsed.
If the service is not carried out, this can lead to incorrect readings which are not
the responsibility of the manufacturer.
You can find further instructions in the chapter on servicing and remedying faults.

Description of the analyser
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3 Description of the analyser
3.1 Introduction
This chapter describes the measuring principle, the construction and accessories
and the consumable materials for the analyser.
This chapter provides preliminary information – but you can find more details on
the operation and function of the equipment in the chapters “Operation – Part 1”
and “Operation – Part 2”.
3.2 Purpose
The SUPER GL easy / easy+ analyser is an automatic analyser for the
determination glucose and / or lactate and / or hemoglobin in 1+50 diluted
samples, e.g. in hemolysed blood samples.
Possible sample material:
- 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 may contain the following anticoagulants / glycolysis inhibitors:
heparin, citrate, fluoride, EDTA.
When using non-flouride-stabilized sample
material, the 15-minute period from taking the
sample until stabilising with haemolysis system
solution should not be exceeded.
The diluted sample material identified with haemolysis system solution is
removed from closed reaction cups.
In detail, the equipment features the following performance characteristics:
- Determination of glucose and / or lactate using the enzymatic-
amperometric measuring principle
- Determination of hemoglobin using photometric measuring principle
- Automatic individual sample measurement
- Automatic calibration
- Serial printer interface
- Serial RS 232 electronic data processing interface
- Interface for PS/2 keyboard or bar code reader
 depending on sensor type
  depending on model of equipment

Description of the analyser
20.08.2012 Page 13 of 42 Rev. 04
3.3 Measuring principle
3.3.1 Measuring principle glucose and lactate determination
Determination of glucose and lactate with the SUPER GL easy / easy+ is based
on an electro-chemical measuring principle with a biosensor. System solution,
calibration, control or patient material is extracted with the aid of a piston pump.
The electrodes in the sensor are separated from the flow of liquid by barrier
layers in which the immobilised enzyme is found. The following illustrations show
the flow diagram of the equipment and the reactions running in the sensor:
Fig. 3.1 Flow chart Type SUPER GL easy
Fig. 3.2 Flow chart Type SUPER GL easy+

Description of the analyser
20.08.2012 Page 14 of 42 Rev. 04
Fig. 3.3 Diagram of measuring principle
Fig. 3.4 Reactions in glucose sensor
Fig. 3.5 Reactions in lactate sensor

Description of the analyser
20.08.2012 Page 15 of 42 Rev. 04
Fig. 3.6 Flow chart photometer
3.3.2 Measuring principle for hemoglobin determination
The hemoglobin in the blood is photometrically determined. To avoid serious
environmental load, the sodium dodecyl sulfate method is used instead of the
hemoglobin cyanide method.
The photometer unit, consisting of LED, flow cuvette, interference filter, photo
detector and electronic evaluation unit, is arranged in front of the biosensor and
the pump. These are used to determine an extinction equivalent value for the
sample solution. The dependence of the extinction on the concentration is
described by the Lambert-Beer-Bouguer law. Under the constraints defined
there, the size of the extinction is proportional to the material concentration.
Determining hemoglobin
The hemoglobin is released from the erythrocytes by the haemolysis which takes
place in the reaction cup after addition of the sample. This reacts with the
sodium dodecyl sulfate contained in the solution in the cup to produce a stable
colour complex.
The pump is used to add the resulting sample solution to the flow cuvette and
the extinctionequivalent quantity is produced with a wave length of 530 nm. With
the aid of a mathematical function, the hemoglobin concentration of the sample
is calculated and produced from this quantity. The parameters for the
mathematical function have been produced by measuring samples with known
hemoglobin content and securely stored in the equipment.

Description of the analyser
20.08.2012 Page 16 of 42 Rev. 04
3.3.3 Plasma-related glucose values
If this function is switched on (explanation of function in the relevant chapter),
this means that the haematocrit value is also determined in addition to the
glucose. Both values are calculated and a plasma-related value is also produced
if full blood samples are used.
If this function is switched off (explanation of function in the relevant chapter), this
means that the glucose value is produced from full blood samples.
3.4 Structure and appearance
Appearance:
Fig. 3.7 View of equipment Fig. 3.8 Accessories
Deliverables
Description Quantity
SUPER GL easy / SUPER GL easy+ 1
Mains cable 1
Power supply unit for device and printer 1
Instruction manual 1
Optional
Printer DPU 414 1
Printer cable 1
EDP cable 1
3.5 Accessories
As described and illustrated above, the SUPER GL easy / easy+ is supplied with
standard accessories. Additional optional accessories can be ordered. The
manufacturer or the authorised sales company will be happy to provide
information on the relevant options.

Description of the analyser
20.08.2012 Page 17 of 42 Rev. 04
3.6 Consumables
The following consumable materials are required for operating the analyser.
- Prefilled reaction cups without capillary tubes or with end-to-end capillary
tubes or with open-end capillary tubes for taking samples
- Calibration solution
- Containerkit for haemolysis system solution and waste
- Glucose sensor or glucose/lactate sensor
- Control materials
Please find the details for using these consumable materials in the operating
chapter of these instructions for use or in the relevant packaging inserts.

Operation – Part 1
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4 Operation – Part 1
4.1 Introduction
This part of the instructions for use summarises all the information needed for
daily operation of the equipment.
In Part 2 there is a summary of all the additional information important for
understanding the functions, additional functions and certain sources of error.
The operating staff must inform themselves about both parts and should also be
able to interpret technically the readings obtained.
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.
4.2 Safety instructions
As already mentioned, some safety instructions must be observed when operating
the equipment in order to ensure correct and error-free work:
- The equipment must be operated for the described indication only. Before
using the equipment, please read all the instructions for use – carefully,
especially the regulations on sampling –.
- Each user is responsible for keeping to 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.
- Use for personal use is expressly forbidden.
- During daily work, regular quality control of the readings obtained should
be noted and additional control readings carried out if necessary.
- The equipment should not be switched off or disconnected from the power
supply when it is still operating. If this should happen, it can lead to faults
in function when it is next switched on. If faulty functioning or incorrect
readings are suspected, please inform those responsible for the equipment.
They may then need to discuss the matter with the manufacturer or the
sales partner in order to solve the problem.
- 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, rinsing with water is sufficient. You can find more information on
this in the safety data sheet for each solution.
- We expressly point out that if the equipment and consumable materials are
not used correctly the protective measures provided for the equipment may
be ineffective.

Operation – Part 1
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4.3 Installation of the equipment
Before first using the equipment please check that the equipment and accessories
are complete by using the list in 3.4. If the accessories are not complete, please
contact your sales partner immediately.
All parts delivered should also be checked to see that they are intact. Proper
operation can only be ensured if original parts and accessories are used. Other
parts or damaged parts must NEVER be used.
Stand the equipment on a horizontal, level and dry work surface. Please choose a
position so that the equipment is protected from direct sunlight and extreme
temperature variations, as this can impair the reading results.
Conditions at the set-up site:
- No direct influence of moisture
- No direct sunlight
- No strong electromagnetic fields or ionising radiation
- No rapid temperature change caused by windows, doors, air conditioning,
etc.
- Level, waterproof surface
- The whole placement surface must be completely free of the floor
Connecting the equipment to the electricity supply (see Fig. 4.1):
Make sure that the voltage given on the power supply unit matches your mains
supply.
Mains connection of the equipment is carried out via the supplied power supply
unit. Connect the mains connection lead to the power supply unit. Insert the plug
into the power supply unit connection on the right side of the housing (marked
with “DC 12V”) and insert the mains connection lead plug into the socket.
Connecting the printer (see Fig. 4.1):
If the SUPER GL easy / easy+ is used with the DPU 414 printer, the printer’s
voltage supply comes via the second power supply unit connection. The voltage
adapter must be switched between the printer and the power supply unit. The
printer cable plug is inserted into the printer connection on the right side of the
equipment housing (“Printer”) and connected to the appropriate socket on the
back of the printer.
EDP – connection (see Fig. 4.1):
Insert the EDP connection cable into the EDP connection socket on the right side of
the housing and connect the other end to the EDP. Make sure you follow the
information in the interface description and from your EDP – company.

Operation – Part 1
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The following illustration shows the connections on the right side of the housing of
the SUPER GL easy / easy+:
also PS/2 – keyboard possible
DIL - switch
Control lamp for using battery device
Fig. 4.1 View of connector panel
4.4 Setting up the equipment
If the equipment has been installed as described above, the following steps must
be carried out so that the equipment can begin working:
1. install the sensor (chapter 6.3.2)
2. install the containerkit (chapter 6.3.3)
3. put on pump head (chapter 6.3.4)
4. insert operation card or a special card
5. select determination method and measuring unit using the DIP switch
This procedure completes the installation of the device.
Warning! To avoid loss of data, the device must not be
switched off unless in “STAND BY” mode or if required
by a corresponding error message.
Turn on the device by a short press at the MENUE key (sound “beep” will show
that device turns on).