Sartorius 16419 Operating Instructions Manual
Operating Instructions | Betriebsanleitung
Sterisart® Universal Pump 16419
Sterisart
®
Universal-Pumpe 16419
1000072189
English .............................................Page 3
Deutsch ............................................Seite 21
Contents
1 General Safety Information ......................................4
®
2 Intended Use of the Sterisart
3 Important Notes on the Safe and Proper Usage of the Sterisart
Universal Pump ...............................................5
4 Unpacking the Pump and Checking the Equipment Supplied.............6
5 Description of the Sterisart
6 Startup......................................................9
7 Application..................................................10
8 Operating the Sterisart
9 Cleaning and Sanitization ......................................12
10 Installation in an Isolator.......................................13
11 Important Notes Concerning the Warranty .........................13
Universal Pump .......................5
®
®
Universal Pump.........................7
®
Universal Pump 16419 .....................11
12 Troubleshooting ..............................................14
13 Technical Specifications........................................15
®
14 Ordering Information for the Sterisart
Universal Pump ...............16
15 Ordering Information for Consumables ...........................17
16 Literature...................................................18
17 Storage and Shipping..........................................18
17.1 Storage .........................................................18
17.2 Returning Devices and Parts........................................18
18 Disposal ....................................................19
18.1 Information on Decontamination ...................................19
18.2 Disposing of Device and Parts ......................................19
18.2.1 Information on Disposal ....................................19
18.2.2 Disposal ..................................................19
19 Conformity..................................................20
20 Legal information about licenses and trademarks ...................20
20.1 Millipore™.......................................................20
Contents 3
1 General Safety Information
Explanation of Safety Symbols Used
These operating instructions contain important information which is visibly marked.
This information must be observed in order to avoid hazards to users as well as to
avoid damage and|or malfunctions to the device.
Symbols in the operating instructions:
Important Note! Important information
Danger! General danger with risk of injury
Laser warning
General information and|or help
Symbols on the manufacturer‘s ID label
AC voltage
Return and disposal
Observe instructions for use
Manufacturer
4 General Safety Information
2 Intended Use of the
®
Sterisart
The new Sterisart® Universal pump is a peristaltic pump equipped with appropriate
devices for attaching a closed sterility test system and a sample container.
The pump draws liquid from the sample container into the specially designed double
tubing, distributing the liquid equally to both sample containers of the sterility test
system. The sample is rinsed in a similar way. After the nutrient media is added, the
sample containers are incubated for a prescribed time and evaluated.
Universal Pump
3 Important Notes on the Safe
®
and Proper Usage of the Sterisart
Universal Pump
– The Sterisart® Universal pump must be switched off before any electrical
connections are made or broken (e.g. when plugging in or unplugging the power
cable or foot switch).
– The Sterisart® Universal pump must only be used with the original current-carrying
parts supplied with it (power cable with ferrite core, D-Sub connecting cable and
foot switch). The D-Sub protective cap supplied must cover the port when the
D-Sub connecting cable is not connected.
– The Sterisart® Universal pump is designed for use with Sterisart® NF filtration
systems. The suitability of any other tubing must be approved by Sartorius.
– Only plastic and glass bottles with a filling volume of 500 ml or less are permitted
to be placed in the delivered bottle holder.
– Only authorized Sartorius service technicians are allowed to open the pump
housing.
– Do not expose the Sterisart® Universal pump to extreme temperatures.
– Improper use or handling will invalidate the manufacturer‘s guarantee.
– Sterisart® Universal pump may only be used with a grounded, readily accessible and
fuse-protected electrical outlet that complies with national standards.
Intended Use of the Sterisart® Universal Pump 5
4 Unpacking the Pump and Checking
the Equipment Supplied
When unpacking the Sterisart® Universal pump 16419 make sure not to leave
any parts in the packaging. The equipment supplied includes the following accessories
(one of each):
– Sterisart® Universal pump 16419
– Power cable (depends on country rating)
– Container for draining
– Pump cover for container for draining (Sterisart® units)
– Drain tubing
– Fastening arm
– Bottle holder
– Support rod
– Bow
– Clamping lever with sleeve
– Operating instructions German | English
6 Unpacking the Pump and Checking the Equipment Supplied
5 Description of the Sterisart®
Universal Pump
Fig. 1
The Sterisart® Universal pump 16419 (see Fig. 1) consists of pump housing (1) with pump
head (2), lever (3), bow (4) and handles (5). On the right handle, there is also a bolt with
a tilting lock for the container for draining (11). The selecting knob (6) is at the front on
the right. The stand (7) with the holding ring for bottles (8) and fastening arm (9) and the
optional ampoule breaker (10) is located on the left side of the pump.
The container for draining (Fig. 1; 11) for the sterility test containers is located on the
right side of the pump. The drain tubing can be attached to the appropriate connector
(barb) on the container for draining (Fig. 1; 12).
Laser warning
The internal barcode scanner emits a laser beam.
Do not look directly into the beam.
Description of the Sterisart® Universal Pump 7
1 2 3 4 5 6
Fig. 2
Located on the rear panel (see Figure 2): a laser warning label (1), On|Off switch (2),
AC power socket (3), socket for the foot switch (4), an RS-232 interface port for
connecting a PC/MMC card reader (5) and the manufacturer’s ID label (6).
8 Description of the Sterisart® Universal Pump
6 Startup
Set up the Sterisart® universal pump ergonomically in a suitable area (cleanroom,
laminar flow work bench, isolator).
Before initial start-up, the accessories supplied must be assembled on the Sterisart®
Universal pump. Please proceed in the following order:
– At the back left, push the support rod (Fig.1, 7) onto the pin of the upper part of the
pump until it is firmly in place. The holes in the foot of the support rod allow the
positioning of the support rod to be altered.
– Fasten the bottle holder (Fig. 1, 8) and the fastening arm (Fig. 1, 9) to the support
rod. If necessary, attach the ampoule breaker (Fig. 1, 10) beforehand.
– Insert the bow (Fig. 1, 4) and the clamping lever (Fig. 1, 3) on the corresponding
bolts on the top of the pump. The lever is jacketed in a plastic sleeve, which can be
removed for cleaning. If signs of wear appear on this sleeve after it has been in use
for some time, it can be re-ordered as a spare part (see chapter “Ordering informa-
tion for the Sterisart® Universal Pump”).
– After connecting the drain tubing to the barb (Fig. 1, 12) of the container for drain-
ing (Fig. 1, 11); attach the container for draining to the appropriate bolts on the
right handle (Fig. 1, 5). The container for draining and the cover plate are attached
by moving the tilting lock.
– Fasten the end of the drain tubing to the appropriate drain.
Very Important Note!
Always make sure that there is a sufficient liquid level differential (> 5 cm) between the container for draining and the drain. This makes safe drainage possible
and prevents backflow into the container for draining. Make sure that the drain
tubing is kept lower than the pump to prevent the drain pan from overflowing.
Treat the waste as a biohazard. Only dispose of it in accordance with current
regulations.
– Plug the foot switch into the designated socket located on the rear panel (see Fig. 2,
4). Fasten the plug to the socket by turning it clockwise.
– Plug the power cable into the male power socket on the back of the Sterisart®
Universal pump and into a grounded electrical outlet (Fig. 2, 3).
– Use the On|Off switch (Fig. 2, 2) at the rear side of the Sterisart® Universal pump to
turn it on.
Startup 9
7 Application
Caution!
General danger with risk of injury
Do not operate the Sterisart® Universal pump until the tubing has been properly
installed. The pump may only be operated with the tubing inserted and only by
one person at a time. Never pump any flammable, corrosive or explosive fluids.
Users should always wear tight-fitting clothing (no ties, etc.).
To be able to operate the pump, Sterisart® sterility test systems must be installed
beforehand. To do this, follow the steps given below:
Remove the sterility test systems from their respective packaging and place the sterility test sample containers in the container for draining on the right side of the pump.
– Now open the lever and the bow.
– Keep the tubing around the rotor of the pump (the arrow on the fixed part sur-
rounding the pump head indicates the subsequent direction of rotation), so that no
kinks occur and the tubing is not under tension (Fig. 3). The tubing is attached by
simply inserting it (with it lying on the ground) and fastening the lever (Fig. 4). In
this way, the tubing is automatically correctly positioned.
Important Note!
When threading the tubing, make sure that it is not kinked or twisted.
Fig. 3
10 Application
– To start the pumping process, the tubing must be fully inserted and the lever
must be engaged. A safety function ensures that the pump does not start if the
lever or the bow are open.
– After threading the tubing and closing the lever, insert the removal spike/needle of
the Sterisart® NF system as described in the instructions for the Sterisart® NF steril-
ity test system. Then attach the test liquid container (e.g., bag or bottle) by hanging
it on the support rod (bag) or by placing it in the holding ring on the support rod
(bottle). The holding ring accepts bottles of various sizes. The holder must be turned
so that the sterility test system tubing is not under tension after the spike | needle
has been inserted and so that the spike | needle cannot slip out of the container.
For testing ampoules, an ampoule breaker is also attached to the support rod.
Use the integrated knife to scratch the neck of the ampoule, then snap off the top.
The broken-off top of the ampoule falls into the collection container (which can be
emptied later).
– For the following pumping process, make sure that the Sterisart® NF sample
containers are correctly positioned in the intended holders, and that the tubing
has been inserted without tension or kinking.
Important Note!
When the lever is opened, the Sterisart® Universal pump is turned off
immediately by a safety function. In this event, the Sterisart® Universal pump
can be restarted after adequately closing all components.
8 Operating the Sterisart® Universal
Pump 16419
The Sterisart® Universal Pump 16419 can be started up either by pressing the selec-
ting knob or by activating the optional foot switch. The speed can be smoothly adjusted using the selecting knob. The pump is switched off by again pressing the selecting knob or by releasing the foot switch.
Fig. 4
Operating the Sterisart® Universal Pump 16419 11
9 Cleaning and Sanitization
Caution!
Ports on the back panel are not tight.
The Sterisart® Universal pump is not suited for sanitization (gaseous or atomized)
with peracetic acid, hydrogen peroxide, or other decontamination procedures
commonly used in isolators, unless it is built into an isolator countertop. These
types of disinfectant can be used when the pump has been professionally
installed in the isolator.
– Before cleaning the pump rotor, turn off the main power switch and unplug the
power cable.
The following parts of the pump have to be removed for cleaning:
– Bow, lever, support rod and container for draining
– Disconnect the pump head:
– The rotor must be turned by hand until the marking on the upper side (black dot)
is pointing backwards.
– The marking indicates the position of the fastening screw that is located in the
rotor mid-section.
– Loosen this screw with a 4-mm Allen wrench. Do not turn the screw out
completely.
– Pull the rotor upwards.
– Pull the speed-selecting knob upwards.
Comply with the IP protection rating! No liquid may enter the Sterisart®
Universal pump. Disconnect the pump from line voltage before any cleaning,
maintenance, or repair work.
Cleaning stainless steel surfaces:
The stainless steel housing can be cleaned at regular intervals. Clean stainless steel
parts with a wet cloth. Customary cleaning agents suitable for stainless steel can be
used without risk. For surface sanitization, use commercially available disinfectants
that are suitable for stainless steel.
Do not use any cleaning agents on the stainless steel housing that contain sodium
hydroxide or acetic, sulfuric or citric acid. The use of steel wool cleaning sponges is
prohibited.
All stainless steel surfaces can be cleaned by wiping with a moist cloth and with the
following products:
– Peracetic acid, H2O2 and acetic acid (2.5%)
– Quaternary ammonium
– Formaldehyde and glutaraldehyde
– Isopropyl alcohol
– Ethanol 70%
Autoclavable at 121°C for 20 min. are bow, lever, speed selecting knob, support rod,
bottle holder, counter-bottle holder and container for draining (complete).
12 Cleaning and Sanitization
Never autoclave the pump rotor and never submerge it into any liquid.
Only use a slightly moistened cloth | tissue for cleaning | desinfecting.
After cleaning, all parts should be secured as described in Chapter “6 Startup,”
page 9. The rotor is assembled as follows:
– The rotor shaft has a groove on the side turned towards the back.
– Push the rotor upwards onto the shaft.
– Turn the marking on the rotor towards the back, so that the groove on the rotor
shaft aligns with the marking on the rotor
– Tighten the screw in the rotor to guarantee that the rotor is firmly seated.
10 Installation in an Isolator
The installation must be carried out by the isolator manufacturer.
To install the Sterisart® Universal pump in an isolator, it must be opened up first.
Make sure to unplug it from AC current (mains supply) before opening it!
During assembly, please follow the installation instructions precisely (part of the
installation kit for isolators, order number 1ZE---0050). The instructions are available
separately from the manufacturer.
11 Important Notes Concerning the
Warranty
The correct functioning and safe use of the Sterisart® Universal pump is only guaranteed when it is operated according to the information given in these instructions.
The equipment manufacturer is responsible only for effects on safety, dependability
and performance of the instrument if assembly, extensions, new settings, changes or
repairs are carried out by persons authorized by him to do so, if the electrical installation in the room is in conformance with IEC requirements and if the equipment is
used in accordance with these operating instructions.
Any changes made to the Sterisart® Universal pump will invalidate the manufacturer‘s
warranty unless they are previously agreed to by authorized Sartorius Service staff, or
carried out by them.
Installation in an Isolator 13
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