Levitronix PuraLev i30SU, User Manual

Page: 37 / 41

User Manual for PuraLev
®
i30SU
www.levitronix.com
PL-4051-00, Rev03, DCO# 20-275
37
6
Instructions for Use of Pump Head
6.1 Description and Preparation
6.1.1 Description
The DCP-30 pump heads are designed for single
use applications in the Life Science industries in
connection with the
PuraLev ® i30SU pump system
components. The wetted parts are made out of
biocompatible materials (FDA, USP VI, Animal-
Free), which can be gamma sterilized.
The
Pump Head is mounted to the MagLev Driver
(integrated motor and controller) via the Pump
Head Socket . The motor is connected to a
controller generating the currents for rotation and
the levitation of the impeller.
Figure 32: Single-use pump head concept
Before using the DCP-30 pump head make
yourself familiar with the following warnings,
cautions and instructions.
6.1.2 Inspection Prior to Use
The pump head should be inspected prior to use
for any damage. Do not use the pump head if any
damage is found. Contact
Levitronix
®
regarding
return of any suspected pump head.
6.1.3 Traceability
For full traceability of the pump head the 6 digit
serial number located on the top of the pump head
shall be used. On the labels of the packaging and
on the biocompatibility declaration this serial
number is the one on the lid (see
Figure 33 ).
Figure 33: Serial number for traceability of pump head
(left: on pump head, right: on label of package and the biocompatibility declaration)
6.2 General Warnings and Cautions
!
WARNING
High Magnetic Field Strength of Impeller.
The pump head contains a rotor magnet with high
field strength. Pace maker may be influenced and
magnetic forces may lead to contusions. Keep
distance to pace makers and handle pump heads with
care.
CAUTION
Magnetic Forces
Pay attention to the magnetic forces when handling
the pump head. It has to be avoided that magnetic
parts are attracted resulting in contamination or da-
mage (for example cracks) of the housing or impeller.
Specifically pay attention to the magnetic forces,
when handling two pump heads at the same time.
CAUTION
Gamma Sterilization
The pump heads DCP-30 have been tested to be
robust against gamma radiation with a dose up to
40 kGy.
Handle the pump heads with care, especially after
gamma radiation with doses above 25 kGy, since the
radiation exposure decreases the flexibility of the
pump head material.
Single-Use
Pump Head
DCP-30
Pump Head Socket
(Bayonet type)
PHS-i30
Locking Pin
Integrated
MagLev Driver
Unique 6 digit serial number for pump head
(Example here: ABC 123)