Miltenyi Biotec CliniMACS Plus System User manual

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CliniMACS® Plus System User Manual (Canadian edition)
37091

37091/04 – ch20 (Issued: 2020-06)
CliniMACS® Plus SystemCliniMACS® Plus System
User Manual (Canadian edition)
Software 2.4x
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Germany
Miltenyi Biotec Technical Support:
[phone]
[phone] (hotline)
[phone]
[email protected]om
www.miltenyibiotec.com

The CliniMACS System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed,
manufactured and tested under a quality system certified to ISO 13485. In the EU, the CliniMACS System components
are available as CE-marked medical devices for their respective intended use, unless otherwise stated. In the US, the
CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing
Set TS and CliniMACS Tubing Set LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved as a Humanitarian Use Device
(HUD), authorized by U.S. Federal law for use in the treatment of patients with acute myeloid leukemia (AML) in first
complete remission. The effectiveness of the device for this indication has not been demonstrated. All other products
of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application
or Investigational Device Exemption (IDE). In Australia, the following components of the CliniMACS Plus System are
included in the Australian Register of Therapeutic Goods (ARTG) and are therefore approved for supply: CliniMACS Plus
Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Set, CliniMACS Tubing Set LS, CliniMACS Depletion Tubing Set,
and CliniMACS PBS/EDTA Buffer. Only those products which are included in the ARTG may be used in Australia. CliniMACS
MicroBeads are for research use only and not for human therapeutic or diagnostic use.
Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research use only and not for
therapeutic or diagnostic use.
Copyright © 2020 Miltenyi Biotec and/or its affiliates. All rights reserved.
No part of this publication may be reproduced, stored in a retrieval system, transmitted, published, or distributed in any
form or by any means, electronically, mechanically, by photocopying, microfilming, recording, or otherwise, without the prior
written consent of Miltenyi Biotec; however, notwithstanding the foregoing, the owners of the CliniMACS Plus System may
make copies solely for purposes of training personnel in the use and servicing of the unit within their business or organization.
CliniMACS, MACS, and the MACS logo are registered trademarks or trademarks of Miltenyi Biotec B.V. & Co. KG and/or its
affiliates in various countries worldwide. All other company, product and service names, logos and brands used herein are
property of their respective owners and are for identification purposes only.

37091/04 – ch20 (Issued: 2020-06) III
Table of contents
Table of contents
1 General ................................................................... 1
1.1 Introduction ....................................................................................... 1
1.2 Service information ............................................................................... 2
1.3 The CliniMACS® Plus Instrument .................................................................... 3
1.3.1 Regulatory information ............................................................................ 3
1.3.2 Intended purpose .................................................................................. 3
1.3.3 Warnings and precautions ......................................................................... 4
1.3.4 Specifications ...................................................................................... 6
1.3.5 Guidance and manufacturer’s declaration on electromagnetic compatibility ......................... 8
1.3.6 Components of the CliniMACS® Plus Instrument ................................................... 11
1.3.7 Unpacking and installation ........................................................................ 13
1.3.8 General set-up menus ............................................................................. 17
1.3.9 Cleaning .......................................................................................... 19
1.3.10 Maintenance ..................................................................................... 19
1.3.11 Instrument disposal ............................................................................... 19
2 Glossary .................................................................. 1
2.1 Glossary of symbols ................................................................................ 1
2.1.1 Safety symbols ..................................................................................... 1
2.1.2 Symbols used for labeling of products .............................................................. 1
2.2 Glossary of terms .................................................................................. 5
3 Customer information ..................................................... 1
3.1 MACS® Magnetic Cell Separation ................................................................... 1
3.2 The CliniMACS® Plus System ........................................................................ 1
3.3 Additional materials required ...................................................................... 2
3.4 Equipment required ............................................................................... 3
3.5 General warnings and precautions ................................................................. 4
3.6 Labeling of cells with CliniMACS® Reagents ......................................................... 7
3.7 High-gradient magnetic cell separation ............................................................. 7
3.8 CliniMACS® Plus Separation strategies .............................................................. 8
3.8.1 Enrichment strategy ............................................................................... 9
3.8.2 Depletion strategy ................................................................................ 10
4 Four STEPS to your target cells ............................................. 1

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4 STEP 1: Cell preparation and magnetic labeling
CliniMACS® CD34 Reagent ......................................................... 1
I. General information ........................................................................... 1
II. Materials required ............................................................................. 2
CliniMACS® Plus CD34 System components .................................................... 2
Additional materials ........................................................................... 2
III. Preparative steps .............................................................................. 3
Preparation of the CliniMACS® PBS/EDTA Buffer ................................................ 3
Labeling and preparation of bags .............................................................. 3
IV. Preparation of leukapheresis product .......................................................... 4
Analysis ....................................................................................... 4
Transfer into Cell Preparation Bag .............................................................. 5
Dilution ....................................................................................... 6
Centrifugation ................................................................................ 7
Volume adjustment ........................................................................... 7
V. Magnetic labeling of cells ..................................................................... 9
Incubation with the CliniMACS® CD34 Reagent ................................................. 9
Removal of excess reagent ................................................................... 10
CliniMACS® CD19 Reagent ......................................................... 1
I. General information ........................................................................... 1
II. Materials required ............................................................................. 2
CliniMACS® Plus CD19 System components .................................................... 2
Additional materials ........................................................................... 2
III. Preparative steps .............................................................................. 3
Preparation of the CliniMACS® PBS/EDTA Buffer ................................................ 3
Labeling and preparation of bags .............................................................. 3
IV. Preparation of leukapheresis product .......................................................... 4
Analysis ....................................................................................... 4
Transfer into Cell Preparation Bag .............................................................. 5
Dilution ....................................................................................... 6
Centrifugation ................................................................................ 7
Volume adjustment ........................................................................... 7
V. Magnetic labeling of the cells .................................................................. 9
Incubation with the CliniMACS® CD19 Reagent ................................................. 9
Removal of excess reagent ................................................................... 10

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Table of contents
4 STEP 1: Cell preparation and magnetic labeling (continued)
CliniMACS® TCRα/β-Biotin ......................................................... 1
I. General information ........................................................................... 1
II. Materials required ............................................................................. 2
CliniMACS® Plus TCRα/β-Biotin System components ............................................ 2
Additional materials ........................................................................... 2
III. Preparative steps .............................................................................. 3
Preparation of the CliniMACS® PBS/EDTA Buffer ................................................ 3
Labeling and preparation of bags .............................................................. 3
IV. Preparation of leukapheresis product .......................................................... 4
Analysis ....................................................................................... 4
Transfer into Cell Preparation Bag .............................................................. 5
Dilution ....................................................................................... 6
Centrifugation ................................................................................ 7
Volume adjustment ........................................................................... 7
V. Labeling of the cells with the CliniMACS® TCRα/β-Biotin ........................................ 9
Incubation with the CliniMACS® TCRα/β-Biotin ................................................. 9
Removal of excess conjugate .................................................................. 9
VI. Magnetic labeling of the cells with the CliniMACS® Anti-Biotin Reagent ........................ 12
Incubation with the CliniMACS® Anti-Biotin Reagent .......................................... 12
Removal of excess reagent ................................................................... 13

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4 STEP 2: Start of the CliniMACS® Plus Instrument and choice of separation program
CD34 SELECTION 1/2 .............................................................. 1
Switch-on of the CliniMACS® Plus Instrument ....................................................... 1
Choice of separation program CD34 SELECTION 1/2 ................................................. 1
DEPLETION 2.1 ................................................................... 1
Switch-on of the CliniMACS® Plus Instrument ....................................................... 1
Choice of separation program DEPLETION 2.1 ....................................................... 1
Sample parameter input ........................................................................... 3
DEPLETION 3.1 ................................................................... 1
Switch-on of the CliniMACS®Plus Instrument ....................................................... 1
Choice of separation program DEPLETION 3.1 ....................................................... 1
Sample parameter input ........................................................................... 3

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Table of contents
CliniMACS® Tubing Set and CliniMACS Tubing Set LS ................................ 1
Preparation for tubing set installation .............................................................. 1
Attach Cell Collection Bag .......................................................................... 1
Attach Priming Waste Bag and insert pre-column ................................................... 2
Insert separation column and load valve no. 5 ...................................................... 4
Load valves nos. 1, 2, 3, and 4 ....................................................................... 5
Load pump tubing ................................................................................. 6
Load valves nos. 7 and 8 ............................................................................ 7
Load valves nos. 6, 9, 10, and 11 .................................................................... 7
Recheck all tubing and attachments ................................................................ 8
Seating of valves ................................................................................... 8
Attach CliniMACS® PBS/EDTA Buffer ................................................................ 9
Start priming ..................................................................................... 10
Check during the priming ......................................................................... 10
Final check of all tubing and attachments .......................................................... 10
Integrity test ...................................................................................... 11
Connect Cell Preparation Bag ..................................................................... 13
Final check of the liquid sensor .................................................................... 13
Alternative installation of CliniMACS® Tubing Sets .............................................. 1
CliniMACS® Depletion Tubing Set .................................................. 1
Preparation for tubing set installation .............................................................. 1
Attach Non-Target Cell Bag, Reapplication Bag, and insert separation column ........................ 2
Load valves nos. 1, 2, 3, 4, and 5 .................................................................... 4
Load pump tubing ................................................................................. 5
Load valves nos. 6, 7, 8, 9, and 10 ................................................................... 6
Recheck all tubing and attachments ................................................................ 6
Seating of valves ................................................................................... 6
Attach CliniMACS® PBS/EDTA Buffer ................................................................ 7
Start priming ...................................................................................... 8
Check during the priming .......................................................................... 8
Final check of all tubing and attachments ........................................................... 8
Integrity test ....................................................................................... 9
Connect Cell Preparation Bag ..................................................................... 11
Final check of the liquid sensor .................................................................... 12
4 STEP 3: Installation of CliniMACS® Tubing Sets

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4 STEP 4: CliniMACS® Plus Separation
CD34 SELECTION 1/2 .............................................................. 1
Separation procedure .............................................................................. 1
Disconnect bags and record process code .......................................................... 3
Unload tubing set and shutdown ................................................................... 4
Analysis of cells .................................................................................... 4
DEPLETION 2.1 ................................................................... 1
Separation procedure .............................................................................. 1
Disconnect bags and record process code .......................................................... 3
Unload tubing set and shutdown ................................................................... 4
Analysis of cells .................................................................................... 4
DEPLETION 3.1 ................................................................... 1
Separation procedure .............................................................................. 1
Disconnect bags and record process code .......................................................... 3
Unload tubing set and shutdown ................................................................... 4
Analysis of cells .................................................................................... 4
5 Troubleshooting .......................................................... 1
5.1 Preparation of the leukapheresis product ........................................................... 1
5.2 CliniMACS® Plus Instrument and CliniMACS Tubing Sets ............................................. 1
5.3 Automated cell separation ......................................................................... 3
5.4 Cell separation performance ...................................................................... 10

1 General
1.1 Introduction
The CliniMACS® Plus System offers a set of tools making high
quality standard cell separations available for therapeutic
applications. The CliniMACS Plus System is based on the
magnetic cell separation technology (MACS® Technology)
developed by Miltenyi Biotec B.V. & Co. KG. Miltenyi Biotec has
made these products available for clinical applications meeting
the requirements of European Regulatory Standards.
Miltenyi Biotec as the manufacturer of the CliniMACS Plus
System does not give any recommendations regarding the use
of separated cells for therapeutic purposes and does not make
any claims regarding a clinical benefit.
For the manufacturing and use of target cells in humans
the national legislation and regulations –e.g., for the EU the
Directive 2004/23/EC (human tissues and cells) or the Directive
2002/98/EC (human blood and blood components)– must
be followed. Thus, any clinical application of the target cells is
exclusively within the responsibility of the user of a CliniMACS
Plus System.
Before using the CliniMACS Plus System or any components
outside the European Economic Community, the regulatory
approval of the CliniMACS Plus System or any CliniMACS
Component in the country must be confirmed.
In Canada, any clinical application of the output product
must be performed in accordance with applicable Canadian
legislation and regulations that pertain to cellular therapies (e.g.
for advanced cellular therapies, the applicable sections of the
Food and Drugs Act and the Food and Drug Regulations).
Limited warranty
Should the CliniMACS Plus System
be used in a manner not explicitly
described in this manual, all warranties
will be null and void.
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General
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1.2 Service information
Miltenyi Biotec Technical Support (Clinical)
For any information regarding the CliniMACS Plus System and
its components, contact the Miltenyi Biotec Technical Support:
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Germany
[phone]
[phone] (hotline)
[phone]
[email protected]
www.miltenyibiotec.com
CliniMACS Plus Instrument information
Record below the model and serial number located on the back
of the CliniMACS Plus Instrument. The operator should refer to
these numbers when calling to obtain information or request
service on the instrument.
Model no.:
Serial no.:
Software version: 2.41
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1.3 The CliniMACS® Plus Instrument
1.3.1 Regulatory information
The CliniMACS Plus Instrument conforms to the Medical Device
Directive MDD 93/42/EEC:
The CliniMACS Plus Instrument complies with the following
standards:
IEC/EN/SN EN 61010-1
UL 61010-1
CAN/CSA-C22.2 No. 61010-1
IEC 60601-1-2
EN 60601-1-2
For applied standard version refer to the respective Certificate
of Conformance.
The CliniMACS Plus Instrument is in conformity with Directive
2011/65/EU of the European Parliament and of the Council of
8 June 2011 on the restriction of the use of certain hazardous
substances in electrical and electronic equipment.
The CliniMACS Plus Instrument is UL Listed (see Figure 1.1).
For regulatory status in countries outside Europe, contact the
authorized local Miltenyi Biotec Service Provider.
1.3.2 Intended purpose
The CliniMACS Plus Instrument including its software is intended
for the in vitro separation of human cells from heterogeneous
cell populations in combination with a CliniMACS Tubing Set,
CliniMACS Reagents and CliniMACS PBS/EDTA Buffer only.
Figure 1.1: UL listing mark, listed as laboratory
equipment
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General
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1.3.3 Warnings and precautions
1. Read and observe all operating instructions carefully (see
Figure 1.2).
2. Equipment safety will be compromised if it is not used
according to the manufacturer’s instructions.
3. The CliniMACS Plus Instrument is equipped with an
extremely strong permanent magnet generating a strong
magnetic field. There is a risk of severe personal injury for
persons carrying pacemakers, brain shunts, or electronic
medical implants.
Keep any magnetic information carriers (such as credit cards
or magnetic tapes), electronic equipment (such as hearings
aids, measuring and control instruments, computers and
watches), and magnetizable tools and objects at a distance
of at least 30 cm from the magnetic cover. These items
may be affected or damaged by the magnetic field (see
Figure 1.3).
4. Column insertion: Do not try to insert the separation
column into the separation column holder or remove the
separation from there in case the magnet unit is switched
on. Contact Miltenyi Biotec Technical Support.
5. The instrument is a protection class I device and may only
be plugged into an outlet with a grounded connection.
6. Before cleaning or maintenance of the instrument, the
power cord cable should be disconnected.
7. To disconnect theinstrument fromthepowersupply unplug
the power cord. Only use the originally supplied power
cord. Ensure that the main switch as well as the connector
for the power cable are easily accessible and located as
close to the operator of the instrument as possible.
8. To prevent the risk of an electric shock, do not remove
the back cover of the instrument. The instrument may
be opened and any spare parts may be exchanged by
authorized personnel only.
9. Movement or vibration may affect the instrument. Do not
place the instrument next to any equipment that vibrates
or can cause the instrument to move.
10. There are no components which can be serviced or
calibrated by the operator.
Figure 1.2: Consult instructions for use.
Figure 1.3: Strong magnetic field
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11. Never leave the instrument unattended during a run. If
an error occurs, the cell separation can be interrupted by
the user at the current step and the operator will have 600
seconds to correct certain errors. If the instrument has
not been restarted after this time period, the run will be
aborted.
12. The pump door should not be left open at any time during
a run. If left open for more than 600 seconds, the run in
process will be aborted.
13. Do not open the door of the peristaltic pump when it is
moving. Keep away from all moving parts.
14. Fluid containers must be handled with caution when near
the instrument. Avoid spills. Do not operate the instrument
if it has been exposed to moisture. Avoid ingress of any
liquid into the valves.
15. Afterrunningapatientsampleandpriortodecontamination,
the instrument should be treated as a biohazard.
16. The instrument may be used repeatedly. It is not intended
for disposal after single use. It must be returned to Miltenyi
Biotec for final disposal (see section 1.3.11).
17. Only components (e.g. CliniMACS Reagents, CliniMACS
Tubing Sets) recommended by the manufacturer must be
used.
18. Allow sufficient air circulation around the instrument
–at least 15 cm on all sides– during operation to ensure
adequate cooling. In the absence of adequate circulation,
ambient air may not cool the instrument to acceptable
operating temperatures.
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1.3.4 Specifications
The technical data of the CliniMACS Plus Instrument are listed
in Table 1.1. WARNING! The instrument shall not be used
outside its specifications.
Technical data
Model CS3
REF 151-01
Dimensions Width: 70 cm
Height: 90–140 cm
Depth: 60 cm
Weight 35 kg
Input voltage 100–240 VAC (Single phase alternating current)
Power
consumption
350 VA
Power source An uninterruptible power source is recommended
(reliable, noise free utility). Recommended UPS: APC
Smart-UPS 1500 VA USB & Serial 230 V, manufactured
by APC (American Power Conversion) or equivalent.
Instrument
power
Instrument power inlet IEC-320-C13
A country specific power cord is supplied with the
CliniMACS Plus Instrument.
Frequency 50/60 Hz
Fuses 2×T4A/250V, 5×20 mm
Use only fuses with UL and European approvals,
acc. to IEC 127-2/III, EN 60127-2/III, DIN 41662.
Operation
conditions
+10 °C to +30 °C (+50 °F to +86 °F) with 0% to 85%
humidity at an altitude of max. 2000 m.
Supply voltage fluctuations up to ±10% of the
nominal voltage. Transient over-voltages present
on the mains supply: category II. The instrument is
suitable for rated pollution degree 2. The instrument
is intended for indoor use only.
Storage
conditions
–10 °C to +60 °C (+14 °F to +140 °F) with 0% to 85%
humidity, when contained and sealed in the outer
packaging provided by the manufacturer
Table 1.1: Technical data of the CliniMACS Plus Instrument
Caution
Changes or modifications not expressly
approved by the manufacturer of the
CliniMACS Plus System could invalidate
the user’s authority to operate this
system.
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- Protection class:
The instrument is a protection class I device (acc. to
DIN 61140) and may only be plugged into an outlet with a
grounded conductor. The protection category according to
DIN EN 60529 is IPX 0.
- Interferences:
This equipment has been tested and found to comply
with the limits for a class A digital device, pursuant to part
15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a
residential installation. This equipment generates, uses
and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause
harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be
determined by turning the equipment offand on, the user
is encouraged to try to correct the interference by one or
more of the following measures:
• Redirect or relocate the receiving antenna.
• Increase the space between the equipment and receiver.
• Connect the equipment to an outlet which is not on the
same circuit as the receiver.
• Consult the dealer or an experienced radio/TV
technician for help.
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1.3.5 Guidance and manufacturer’s declaration on electromagnetic compatibility
Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs
to be installed and put into service according to the EMC information provided in the accompanying documents.
Note: The emissions characteristics of this instrument make it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this
instrument might not offer adequate protection to radio-frequency communication services. The user might
need to take mitigation measures, such as relocating or re-orienting the instrument.
WARNING! Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the CliniMACS Plus
Instrument, including cables specified by the manufacturer. Otherwise, degradation of the performance
of this equipment could result.
EMC compliance with IEC 60601-1-2:2014 has been attested for the provided power cable. The use of other
power cables may result in increased electromagnetic emissions or decreased immunity of the CliniMACS Plus
Instrument. If the provided power cable is missing, contact Miltenyi Biotec for information on a replacement part.
Guidance and manufacturer’s declaration – Electromagnetic emissions
The CliniMACS Plus Instrument is intended for the use in the professional facility healthcare environment. The instrument is not
intended to be used near active HF surgical equipment. The customer or user of the instrument should assure that it is used in
such an environment.
Emissions test Compliance
RF Emissions
CISPR 11
Group 1
RF Emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/Flicker emissions
IEC 61000-3-3
Complies
Table 1.2: Guidance and manufacturer’s declaration – Electromagnetic emissions
WARNING! Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
Based on technical limitations of the internal power supply voltage, interruptions on power supply input lines for
longer than 10 ms may lead to cessation of the separation process (power failure). The separation process cannot
be resumed after a power failure. It is recommended that the instrument is powered from an uninterruptible
power supply or a battery that starts up within 10 ms.
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Guidance and manufacturer’s declaration – Electromagnetic immunity
The CliniMACS Plus Instrument is intended for the use in the professional facility healthcare environment. The instrument is not
intended to be used near active HF surgical equipment. The customer or user of the instrument should assure that it is used in
such an environment.
Immunity test IEC 60601-1-2 Test level Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
±8 kV contact discharge
±2 kV, ±4 kV, ±8 kV, ±15 kV air discharge
±8 kV contact discharge
±2 kV, ±4 kV, ±8 kV, ±15 kV air discharge
Electrical fast transients
(Bursts)
IEC 61000-4-4
±2 kV 100 kHz repetition frequency
Power supply lines
±1 kV 100 kHz repetition frequency
Input/output lines
±2 kV 100 kHz repetition frequency
Power supply lines
±1 kV 100 kHz repetition frequency
Input/output lines
Surges
IEC 61000-4-5
±0.5 kV, ±1 kV line to line
±0.5 kV, ±1 kV, ±2 kV line to ground
±0.5 kV, ±1 kV line to line
±0.5 kV, ±1 kV, ±2 kV line to ground
Voltage dips, interruptions,
and variations
IEC 61000-4-11
0% UTduring 0.5 cycle
@ 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°
0% UTduring 1 cycle and
70% UTduring 25/30 cycles (single phase) @ 0°
0% UTduring 250/300 cycle
0% UTduring 0.5 cycle
@ 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°
0% UTduring 1 cycle and
70% UTduring 25/30 cycles (single phase) @ 0°
Rated power frequency
magnetic field
IEC 61000-4-8
30 A/m 50Hz or 60Hz 30 A/m 50 Hz or 60 Hz
Conducted disturbances
induced by RF fields
IEC 1000-4-6
3 V (0.15 MHz to 80 MHz)
6 V in ISM bands between
0.15 MHz and 80 MHz 80% AM @ 1kHz
3 V (0.15 MHz to 80 MHz)
6 V in ISM bands between
0.15 MHz and 80 MHz 80% AM @ 1 kHz
Radiated RF EM fields
IEC 61000-4-3
3 V/m (80 MHz–2.7 GHz)
80% AM @ 1kHz
3 V/m (80 MHz–2.7 GHz)
80% AM @ 1 kHz
Proximity fields from RF
wireless communication
equipment
IEC 61000-4-3
See table below:
Specifications for immunity to RF wireless
communication equipment
See table below:
Specifications for immunity to RF wireless
communication equipment
NOTE UTis the a.c. mains voltage prior to application of the test level.
Table 1.3: Guidance and manufacturer’s declaration – Electromagnetic immunity
The performance of the device that was determined to be essential performance:
1. Establishing and maintaining the intended flow path.
2. Delivering the specified flow.
3. Setting the necessary magnetic field in the separation column.
4. Displaying user information on progress of the process.
5. Running the sequence as intended.
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Guidance and manufacturer’s declaration – Electromagnetic immunity to RF wireless communication equipment
Test
Frequency
(MHz)
Band
(MHz)
Service Modulation Maximum
Power
(W)
Distance
(m)
Immunity
Test Level
(V/m)
Compliance
Level (V/m)
385 380
–
390
TETRA 400 Pulse
modulation
18 Hz
1.8 0.3 27 27
450 430
–
470
GMRS 460, FRS 460 FM ±5 kHz
deviation 1
kHz sine
2 0.3 28 28
710
745
780
704
–
787
LTE Band 13, 17 Pulse
modulation
217 Hz
0.2 0.3 9 9
810
870
930
800
–
960
GSM 800/900, TETRA 800,
iDEN 820, CDMA 850,
LTE Band 5
Pulse
modulation
18 Hz
2 0.3 28 28
1720
1845
1970
1700
–
1990
GSM 1800; CDMA 1900;
GSM 1900; DECT; LTE Band
1, 3, 4, 25; UMTS
Pulse
modulation
217 Hz
2 0.3 28 28
2450 2400
–
2570
Bluetooth, WLAN,
802.11 b/g/n, RFID 2450,
LTE Band 7
Pulse
modulation
217 Hz
2 0.3 28 28
5240
5500
5785
5100
–
5800
WLAN 802.11 a/n Pulse
modulation
217 Hz
0.2 0.3 9 9
Table 1.4: Guidance and manufacturer’s declaration – Electromagnetic immunity to RF wireless communication equipment
37091/04 – ch20 (Issued: 2020-06)
CliniMACS® Plus System User Manual (Canadian edition)
1 – 10

1.3.6 Components of the CliniMACS® Plus
Instrument
The key components of the CliniMACS® Plus Instrument are an
integrated computer, a magnetic separation unit, a peristaltic
pump, a liquid sensor, and pinch valves.
The integrated microcomputer controls all electromechanical
components of the instrument and directs the system to perform
procedures in a standard sequence. The keypad and display
guide the operator through the set-up procedure and allow
monitoring of automatic system operations (see Figure 1.4).
The magnetic separation unit includes the movable permanent
magnet and the separation column holder for the separation
column. During the separation, the peristaltic pump controls the
flow rate through the tubing sets. The liquid sensor monitors the
flow of labeled cell suspension into the tubing set. Disruption
of continuous fluid flow through the sensor automatically
advances the separation program to the next phase of the
separation process. Eleven pinch valves ensure controlled flow
of buffer and cell suspension throughout the procedure.
The CliniMACS Plus Software offers the operator the choice
between various separation programs. For further details see
chapter 4. The CliniMACSPlus Instrument and CliniMACS Tubing
Sets allow the operator to perform cell separations in a closed
and sterile system.
The power connection module (see Figure 1.5) is located at the
rear of the instrument. Viewed from behind, the connection
consists of two sections. The left section is the recessed male
3-pin connector to which the power cord is attached. The right
section is the main ON/OFF switch. When positioned to the left,
the switch is ‘OFF’ (O). When positioned to the right, the switch
is‘ON’(I).
Figure 1.4: Display with touchscreen
Run
key
Key-
pad
Enter
key
Undo
key
Stop
Key
Important
This CliniMACS Plus System User Manual
only contains the instructions for clinical
applications using the CliniMACS
Reagents.
Figure 1.5: Power connection
Main ON/OFF switch
Power connection,
recessed male 3-pin connector
37091/04 – ch20 (Issued: 2020-06)
General
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