Lonza 4D-Nucleofector User manual

› created: 2019-06-13 › revised: page: 1 of 2
Inspection Equipment for 4D-Nucleofector™ LV Unit
This inspection equipment is a fixed resistor cartridge (560 Ω resistor) that can be used to check the functionality
(electrical performance) of the 4D-Nucleofector™ LV Unit prior to use.
AXP-1005
Inspection Equipment 4D-Nucleofector™ LV Unit
Test cartridge orientation: External part for handling (A)
and internal part for insertion into cartridge slot (B).
Test cartridge inserted into 4D-Nucleofector™ LV unit
Instructions for use:
1. Switch on the 4D-Nucleofector™ System. If already
turned on go back to the home screen
2. Select “LV Unit” and then “1 mL cartridge”
3. Insert inspection equipment
4. Select any solution code (needs to be done first to be
able to select a pulse code)
5. Select the first pulse code setting indicated in the
table below (CA-100) and press OK
6. Press START
7. Observe the LEDs on the front of the inspection
equipment
8. Check the result window on the screen (for expected
results see table below)
9. Repeat steps 5-8 for remaining program codes (EN-
200, FF-100 and CA-137). Press the “Back” Button to
enter different program code
Pulse
code Expected Result
CA-100 The six LEDs do not flash up.
No error message.
EN-200 The six LEDs flash up twice each for more than
1 sec. No error message.
FF-100 The six LEDs flash up twice each for less than 1
sec. No error message.
CA-137 The six LEDs flash up twice each for less than 1
sec. No error message.
IMPORTANT NOTE: Please do not use other pulses as the ones
indicated as this may damage the test equipment. If you want to use
another pulse for a certain reason, please contact Lonza to verify whether
that pulse might be suited.
Note: For a full IQOQ of the device, please refer to the respective IQOQ protocol.

› created: 2019-06-13 › revised: page: 2 of 2
Quality Certification
Inspection Equipment 4D-Nucleofector™ LV Unit
AXP-1005
Inspection Equipment 4D-Nucleofector™ LV Unit
Test cartridge orientation: External part for handling (A)
and internal part for insertion into cartridge slot (B).
Hereby Lonza Cologne, Germany confirms that this
Inspection Equipment for the 4D-Nucleofector™ LV Unit
has passed a quality control procedure comprising:
 Optical check
 Mechanical check
 Electronic check
 Safety Check
Standards
The Inspection Equipment 4D-Nucleofector™ LV Unit was
tested by TÜV Rheinland Product Safety GmbH and found
to be in compliance with the following standards:
− IEC 61010-1
Declaration of Pack Material
For packing materials, no natural wood is used.
For further details regarding technical specifications and
technical standards, please refer to the use instructions
(page 1) or contact your local representative.
Dr. Rainer Hammermann
Head of Quality