SAMIX ES500 User manual

Instruction Manual SAMIX®ES500
EN122017

SAMIX®ES500
Original Instruction Manual
© 2017 SAMIX GmbH
This instruction manual is protected by copyright laws. Disclosure, as
well as reproduction of this document, utilization and communication of
its content, are prohibited, unless explicit written consent has been gran-
ted by SAMIX GmbH. Offenders will be held liable for the payment of
damages. All rights reserved in the event of the grant of a patent, utility
model or design.

Inhaltsverzeichnis
1 Basic comments .........................................................................5
1.1 General specications...........................................................5
1.2 Intended use .........................................................................5
1.3 Foreseeable misuse..............................................................5
1.4 Limits of operating range.......................................................5
1.5 Manufacturer's warranty........................................................6
1.6 Scope of delivery...................................................................6
1.7 Manufacturer's Customer Service.........................................6
2 Safety ...........................................................................................7
2.1 Structure of safety notices.....................................................7
2.2 General safety notices ..........................................................8
2.3 Safety devices.......................................................................9
3 Technical description ...............................................................10
3.1 Technical data .....................................................................10
3.2 Product range......................................................................10
3.2.1 Mixing blade.............................................................11
3.2.2 Jars..........................................................................13
3.2.3 Assignment of mixing blades to the jars ..................15
4 Transportation, packaging and storage .................................17
4.1 Transportation .....................................................................17
4.2 Packaging ...........................................................................17
4.3 Storage................................................................................17

5 Initial operation .........................................................................18
5.1 Site selection.......................................................................18
5.2 Initial operation....................................................................19
5.3 Function check ....................................................................19
6 Operation...................................................................................21
6.1 Control panel and display....................................................21
6.2 Preparation of mixing unit ...................................................23
6.3 Preparation of mixing process.............................................25
6.4 Switching on and selecting the operating mode..................26
6.5 Mixing process in AUTO operating mode............................29
6.5.1 Starting the mixing process .....................................29
6.5.2 Switching off and removing the mixing unit .............31
6.6 Mixing process in MANUAL operating mode.......................32
6.6.1 Starting the mixing process .....................................32
6.6.2 Manual free spin motion ..........................................34
6.6.3 Switching off and removing the mixing unit .............37
6.7 Final operations...................................................................38
7 Maintenance, repair and cleaning ...........................................41
7.1 Service and warranties in Germany ....................................41
7.2 Maintenance........................................................................42
7.3 Cleaning ..............................................................................43
8 Fault causes/troubleshooting..................................................44
8.1 Instructions in the event of faults.........................................44
8.2 Fault messages...................................................................45
8.3 Possible fault sources to avoid............................................46
9 Waste disposal..........................................................................48

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SAMIX GmbH
Basic comments
1 Basic comments
1.1 General specications
The SAMIX®ES500 is manufactured by SAMIX GmbH, and its safety has been che-
cked by the TÜV Rhineland.
For safe operation, and to avoid personal injuries and material damage,
• the instruction manual must be read carefully and understood,
• the instruction manual must always be available at the mixer and observed.
The current instruction manual describes the structure, operating principle and hand-
ling of the SAMIX®ES500 mixer.
1.2 Intended use
The SAMIX®ES500 mixer is solely intended for the manufacture of pharmaceutical
and cosmetic products.
1.3 Foreseeable misuse
The following usage is considered foreseeable misuse:
• use of excessively large jars (nominal volume: 1000 ml)
• operation of mixing blades without jar
• implementing the mixing process in MANUAL operating mode, whereby the shaft of
the mixing blade is not properly engaged in the bayonet mount of the device
• no coaxial guidance of the jar to the device
1.4 Limits of operating range
SAMIX®devices are designed for operation in a normal room atmosphere. An ambi-
ent temperature of 15 - 30 °C and relative air humidity below 80% are recommended.

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1.5 Manufacturer's warranty
As a customer, you also receive explicit warranty rights from the manufacturer with
the enclosed manufacturer's warranty. Please note the details in the enclosed docu-
mentation.
1.6 Scope of delivery
Check your purchase for completeness immediately upon receipt. The scope of de-
livery includes:
• SAMIX®ES500
• Accessories
• Instruction manual
When checking for completeness, please also observe the information in the enc-
losed document "Installation Qualication (IQ)".
If there are parts missing or damaged, please contact the manufacturer.
1.7 Manufacturer's Customer Service
SAMIX GmbH
Am Köhlersgehäu 50
98544 Zella Mehlis
Germany
www.samix.com
[email protected]
Tel.: [phone]
Fax: [phone]

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SAMIX GmbH
Safety
2 Safety
2.1 Structure of safety notices
The safety notices in this document are marked with safety symbols and designed in
accordance with the SAFE principle. They contain information on the type and source
of danger, possible consequences, as well as measures to prevent the danger.
DANGER
Warns against an accident which occurs when the instructions are not followed. The accident
leads to serious, possibly life-threatening, injuries or death, for e.g. by touching high-voltage
electrical units.
WARNING
Warns against an accident which occurs when the instructions are not followed. The accident
leads to serious, possibly life-threatening, injuries or death, for e.g. by touching high-voltage
electrical units.
CAUTION
Warns against an accident which occurs when the instructions are not followed. The accident
may cause minor injuries, for e.g. burns, wounds, incisions or bruises.
ATTENTION
Warns against possible material damage.
NOTICE
Important general information.
NOTICE
Important information on environment protection.

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2.2 General safety notices
WARNING
Risk of injury from rotating parts and during the automatic lifting function!
Do not touch rotating parts! Keep long hair, ties, scarves, etc., away from rotating parts and
the lifting mechanism.
Only use mixing blades with the SAMIX® ES500 in jars which have been rmly screwed in.
In the event of an emergency, immediately switch off the device using the power switch or
disconnect the connector!
WARNING
Risk of injury from handling hazardous materials!
Do not operate SAMIX®devices in a dangerous atmosphere. Observe the relevant safety re-
gulations when handling hazardous substances (for e.g. combustible liquids such as alcohol)!
HINWEIS
If the device has been disconnected from the mains while performing a mixing program, the
mixing process has to be repeated. The mixing program is not continued after the interruption.
HINWEIS
If the mixing process was mechanically interrupted, the device switches off due to an overload
and has to be switched off for cooling using the power switch. After cooling the mixing process
has to be repeated.
Also observe the following information in order to avoid material damage:
• Only connect SAMIX®devices to appropriately grounded sockets with 230 V or with
country-specic nominal voltage which have been installed in accordance with DIN
VDE 0100.
• Acclimatize the SAMIX®ES500 to room temperature for roughly 30 minutes before
the initial operation or after a prolonged storage time in cold rooms.
• SAMIX®devices are designed for operation in a normal room atmosphere. Only
operate the SAMIX®devices at an ambient temperature of 15 - 30 °C and relative
humidity below 80%.
• Only operate the mixing blade in jars which have been fastened with screws.
• Do not immerse SAMIX®devices in water.
• Only allow skilled electricians to install or remove electrical parts.
NOTICE
If SAMIX®devices are not used in accordance with this instruction manual or with products not
supplied or recommended by the manufacturer, the warranty becomes null and void and the
intended protection may be affected.

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SAMIX GmbH
Safety
2.3 Safety devices
For substances with high viscosity, a cooling time of 30 minutes is required after a
mixing period of 5 minutes at maximum speed (2100 rpm) in order to not overload the
SAMIX®ES500. The possible working time of the device increases if substances with
a lower viscosity or lower quantities are used.
NOTICE
In the event of an overload, a thermal safety element shuts down the SAMIX®ES500.

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3 Technical description
3.1 Technical data
Name Value
Mains connection 230 V/50 Hz; 120 V/60 Hz
Overall power consumption 270 W
Power consumption (mixing engine) 220 W
Power consumption (lifting engine) 50 W
Type of operation KB 5
30 minute interval after 5 minutes of mixing
Protection class I
Protection type IP 21
Adjusting knob electronically controlled in 10 stages (650 - 2100 rpm)
Time setting innitely variable (electronic)
SAMIX®jar size 15 - 500 ml (nominal volume)
Weight 9.5 kg
Dimensions (L x B x H in mm) 300 x 300 x 650
Conformity sign CE sign
Tab. 1: Technical data
3.2 Product range
The SAMIX®product range includes:
• Standard mixing blade (SMB)
• Disposable blade (DSP)
• Jars
• Dosing aids (vario nozzles, applicators and ExactDose)
• Removal or lling aids (spindle, coupling and the SAMIX®jar pump with a nominal
volume from 300 ml)
All SAMIX®products are compatible with each other.

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SAMIX GmbH
Technical description
3.2.1 Mixing blade
Due to the even upward and downward movement of the SAMIX®jar (see section
„3.2.2 Jars“), a consistent mix of the substances is achieved with use of the mixing
blade (SMB or DSP).
NOTICE
Do not use mixing blades which are bent or defective in any other way.
Wetting the SAMIX®jar and the SAMIX®mixing blade with an ointment base protects the plas-
tic parts against abrasion and wear. Discoloration of the mixing blade is generally harmless.
NOTICE
Mixing blades cannot be placed in the microwave.
Cleaning the mixing blade
ATTENTION
Risk of material damage!
SAMIX®devices and products cannot be treated with sharp objects or abrasive cleaning
agents.
1.Clean the mixing blade with cellulose.
2.Wash the mixing blade under hot water or in the dishwasher.
Standard mixing blade (SMB)
Standard mixing blades (see Fig. 1) are adjusted to the respective jar (see section
„3.2.3 Assignment of mixing blades to the jars“).
Fig. 1: Standard mixing blade (SMB)

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Before use, check whether
• the mixing blade is the right length and size
• the mixing blade is clean. If necessary, disinfect the mixing blade (for e.g. with 70%
isopropyl alcohol).
Disposable blade (DSP)
NOTICE
In the case of substances with strong colors, it is recommended to use the disposable blade.
Disposable blades (see Fig. 2) are adjusted to the respective jar (see section „3.2.3
Assignment of mixing blades to the jars“).
Fig. 2: Disposable blade (DSP): Overview
The DSP are supplied in dispensers, which allow individual removal with the shaft.
Before the mixing process, apply gentle pressure to the mixing blade of the DSP and
turn it in an anticlockwise direction with the shaft of the DSP.
NOTICE
Ensure correct orientation in accordance with Fig. 3. The injection point faces upwards, the
slanted outer contours face downwards.

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SAMIX GmbH
Technical description
After the mixing process, the shaft of the DSP is disconnected from the mixing blade
of the DSP by turning in a clockwise direction (see Fig. 3).
Fig. 3: Disposable blade (DSP): Assembly and disassembly
1 DSP shaft 2 Injection point
NOTICE
The cleaning is restricted to the shaft of the DSP.
3.2.2 Jars
Fig. 4: Jar
1 Jar housing 3 Jar cap
2 Jar lid 4 Jar base (movable)

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Jars (see Fig. 4) have a movable base and can be mixing and dispensing containers.
The jar lid seals the jar without a loss of the active ingredients. As mixing containers,
jars guarantee manufacture in the air-reduced mixing chamber free of evaporation
and contamination. As dispensing containers, jars correspond to the quality assu-
rance guideline of the German Chamber of Pharmacists. The small dispenser ope-
ning without an environmental contamination area guarantees the minimization of
negative quality effects (for e.g. by nger germs) as required by § 13 ApBetrO for the
dispensing of the ointment or cream from the jars.
NOTICE
A jar is a disposable container and cannot be rinsed before use. Otherwise, the inspected
sterility is jeopardized.
SAMIX®jars are supplied in the following sizes:
Nominal volume
(lling volume)
Nominal volume
(lling volume)
Nominal volume
(lling volume)
15 (28) ml 50 (70) ml 300 (390) ml
20 (33) ml 100 (140) ml 500 (600) ml
30 (42) ml 200 (280) ml 1000 (1250) ml
Tab. 2: Jar sizes
NOTICE
Only use jars with a nominal volume up to 500 ml for the SAMIX®ES500.
Jars are supplied sealed in a lm sleeve.
NOTICE
Also after the beginning of the lm sleeve it is recommended to store non-used jars in the lm
sleeve to protect against possible dust contamination.
NOTICE
SAMIX®jars are subject to regular checks in accordance with ZL packaging regulation DK
II/94. An analysis certicate is issued after batch-dened inspections. The documentation of
primary packaging material in the pharmacy includes the retention of the manufacturer's in-
spection certicate (analysis certicate) after a visual incoming test. This is adhered to the
lm sleeve containing the jars. It can be removed from the lm sleeve and kept with the
documentation.
NOTICE
SAMIX®jars are designed for one-off use. Multiple usage as a mixing container is not permit-
ted for hygienic and technical reasons.

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SAMIX GmbH
Technical description
3.2.3 Assignment of mixing blades to the jars
NOTICE
An incorrect assignment of the mixing blades to the jars can trigger fault messages or mean
that the incorrectly prepared mixing unit cannot be screwed into the oscillation arm.
Standard mixing blade (SMB)
Ensure correct assignment of the mixing blades to the corresponding jars. The SMB
for jars with a nominal volume of 100, 200, 300 and 500 ml have the same diameter
of the mixing blade, but differ in the length of the shaft (see Fig. 5).
Disposable blade (DSP)
There are also different shaft lengths for DSP. The two available DSP shafts are
marked for the use of jars with a nominal volume between 15 and 100 ml or 200 ml,
and must be combined with the respective DSP. For jars with a nominal volume of
100 and 200 ml, the same DSP are used but with different shafts.
NOTICE
Also observe the operating instructions enclosed with the mixing blade shafts.

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Fig. 5: Assignment of the standard mixing blade with different shaft lengths

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SAMIX GmbH
Transportation, packaging and storage
4 Transportation, packaging and storage
4.1 Transportation
CAUTION
Risk of crushing when lifting and transporting the SAMIX®ES500.
It is recommended to call on the assistance of a second person when lifting and transporting
the SAMIX®ES500.
The SAMIX®ES500 is sent in a cardboard box.
4.2 Packaging
Store the packaging (cardboard box and inserts) in case you have to send in the
SAMIX®ES500.
4.3 Storage
Protect the SAMIX®ES500 against direct sunlight, extreme humidity and huge tem-
perature uctuations.
Store the SAMIX®ES500 at an ambient temperature between +15 °C and +30 °C and
relative humidity below 80%.

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5 Initial operation
CAUTION
Risk of crushing when lifting and transporting the SAMIX®ES500.
It is recommended to call on the assistance of a second person when lifting and transporting
the SAMIX®ES500.
5.1 Site selection
Choose a suitable location for the SAMIX®ES500. Observe the following information:
• Position the SAMIX®ES500 on steady, even ground.
• Ensure that there is enough space for the operation of the SAMIX®ES500. The
power switch and mains connector must be easily accessible.
• SAMIX®devices satisfy the safety standards for laboratory equipment. Choose a
location for the device which prevents handling by unauthorized people.
• Ensure good ventilation in the area of the SAMIX®ES500.
• Choose a location away from the direct air ow of air conditioning systems, hea-
ters, open windows or fans.
• Protect the SAMIX®ES500 against direct sunlight, extreme humidity (max. 80%)
and high temperature uctuations. An ambient temperature between +15 °C and
+30 °C is recommended.
• Keep the SAMIX®ES500 clean, dry and dust-free.
NOTICE
When checking for suitable erection conditions, please also observe the information in the
enclosed document "Installation Qualication (IQ)".

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SAMIX GmbH
Initial operation
5.2 Initial operation
ATTENTION
Risk of material damage from condensation in the device!
Acclimatize the SAMIX®ES500 to room temperature for roughly 30 minutes before the initial
operation, in the case of low temperatures or after a prolonged storage time in cold rooms.
1.Check the supply connections. Observe the information in the enclosed document
"Installation Qualication (IQ)".
CAUTION
Risk of injury from unexpected startup of the device!
Before connecting the SAMIX®ES500, check that the power switch at the pedestal is switched
off on the back of the device.
2.Connect the power cord of the SAMIX®ES500 to the socket.
The device is now ready for operation.
NOTICE
In the event of an emergency, the SAMIX®ES500 can be shut down by switching off the de-
vice with the power switch or disconnecting the power cord from the socket.
5.3 Function check
Perform a function check in accordance with the details under "Function check or
initial operation" in the enclosed document "Installation Qualication (IQ)".
NOTICE
The operation of the SAMIX®ES500 using the control panel and display is described in detail
in chapter „6 Operation“.

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1
2
5
4
3 6
Fig. 6: SAMIX®ES500
1 Drive head 4 Oscillation arm
2 Control panel and display 5 Mixing unit
3 Power switch 6 Power cord