Miltenyi Biotec MACS TubeSealer User manual
MACS® TubeSealer
User Manual
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 Prodigy System are included in the Australian Register of Therapeutic
Goods (ARTG) and are therefore approved for supply: CliniMACS Prodigy, CliniMACS CD34 Reagent, CliniMACS
Prodigy Tubing Sets, 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.
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unit within their business or organization.
CliniMACS, CliniMACS Prodigy, MACS, and the Miltenyi Biotec logo are registered trademarks or trademarks of Miltenyi
Biotec B.V. & Co. KG and/or its affiliates in various countries worldwide. All other trademarks mentioned in this
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MACS® TubeSealer
User Manual
Issued: 2020-05
38004/04
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Germany
Miltenyi Biotec Technical Support:
+49 2204 8306-8484
+49 2204 8306-80 (hotline)
+49 2204 8306-89
www.miltenyibiotec.com
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3
Essential information
This user manual provides instructions, warnings, precautions, and other
important information for the use of the MACS® TubeSealer which is an
accessory to the CliniMACS Prodigy®. For information on the use of the
CliniMACS Prodigy, specific applications run on the CliniMACS Prodigy, or
further information, warnings, and precautions regarding the operation of the
CliniMACS Prodigy System, refer to the respective CliniMACS Prodigy User
Manual.
The operation of the CliniMACS Prodigy System must be performed by
trained operators only. Before putting the system into operation, care-
fully read and understand the safety information, warnings, precautions,
and instructions for proper operation of the MACS TubeSealer provided
in the instructions for use of the CliniMACS Prodigy System components
(including, without limitation, the safety information in this user manual,
chapter 3 “Important safety information”) and in any safety-related
recommendations issued by Miltenyi Biotec. The operator must adhere to
all instructions and procedures at all times during the operation of the
heat sealer, confirming that all safety information, warnings, precautions,
and instructions are observed. Failure to follow the safety information,
warnings, precautions, and instructions contained in the instructions for
use could result in heat sealer malfunction, property damage, personal
injury, and/or death. Equipment safety may be compromised if the heat
sealer is not used according to the manufacturer’s instruction.
Retain the instructions for use for future reference. They should be kept
accessible and readily available, together with all other safety and
operating documentation, during the entire life cycle of the heat sealer
for all personnel responsible for installation, operation, and
maintenance.
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Table of contents
1 Introduction 7
1.1 General information 7
1.2 Technical support 7
2 Glossary 9
2.1 Graphical depiction 9
2.2 Glossary of symbols and terms 10
3 Important safety information 11
4 MACS® TubeSealer 17
4.1 Regulatory information 17
4.2 Technical data 18
4.3 Components of the MACS® TubeSealer 19
4.4 Unpacking and installation 20
4.4.1 Unpacking and inspection of spare part 20
4.5 Operating instructions 20
4.5.1 Description of sealing 21
4.5.2 Environmental requirements 22
4.6 Cleaning and disinfection 23
4.7 Disposal 25
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1
INTRODUCTION
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Introduction
1.1 General information
The MACS TubeSealer is a fully automatic accessory for sealing PVC and EVA
tubing. The hand unit is connected to the CliniMACS Prodigy by a cable. The
sealing takes place in the hand unit when the trigger is pressed. All CliniMACS
Prodigy Tubing Sets as well as different types and sizes of tubing can be used
and the necessary sealing time is self-adaptive to fit the tubing used.
1.2 Technical support
For information or support, contact Miltenyi Biotec Technical Support:
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Germany
+49 2204 8306-8484
+49 2204 8306-80 (hotline)
+49 2204 8306-89 (operation hours)
www.miltenyibiotec.com/support
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2
GLOSSARY
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2
Glossary
2.1 Graphical depiction
The following chart depicts the panels used in this user manual to inform the
user about potential risks if the outlined warnings and precautions are not
followed. The hazard level classifies the hazard, as described below. The level,
type, and source of the hazard, as well as potential consequences, prohibitions,
and measures are indicated as follows. Icons on the left side specify the risk.
Indicates a hazardous situation which, if not avoided, could result in
death or serious injury.
Indicates a hazardous situation which, if not avoided, could result in minor or
moderate injury.
Addresses practices or information not related to personal injury but may lead
to property damage.
IMPORTANT
Advises the user of important practices or information not related to personal injury
nor property damage.
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2.2 Glossary of symbols and terms
An overview of symbols and terms used for the MACS TubeSealer is provided in
the CliniMACS Prodigy User Manual (Instrument). The glossary of symbols
depicts the symbols used for labeling of the CliniMACS Products.
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IMPORTANT SAFETY INFORMATION
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Important safety information
The operation of the CliniMACS Prodigy System must be performed by
trained operators only. Before putting the system into operation, care-
fully read and understand the safety information, warnings, precautions,
and instructions for proper operation of the MACS TubeSealer provided
in the instructions for use of the CliniMACS Prodigy System components
(including, without limitation, the safety information in this user manual,
chapter 3 “Important safety information”) and in any safety-related
recommendations issued by Miltenyi Biotec. The operator must adhere to
all instructions and procedures at all times during the operation of the
heat sealer, confirming that all safety information, warnings, precautions,
and instructions are observed. Failure to follow the safety information,
warnings, precautions, and instructions contained in the instructions for
use could result in heat sealer malfunction, property damage, personal
injury, and/or death. Equipment safety may be compromised if the heat
sealer is not used according to the manufacturer’s instruction.
Retain the instructions for use for future reference. They should be kept
accessible and readily available, together with all other safety and
operating documentation, during the entire life cycle of the heat sealer
for all personnel responsible for installation, operation, and
maintenance.
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Hazards to users, instrument damage, and/or malfunction, unpredictable
results, premature wear and tear, and/or reduced life time of the heat
sealer if the following safety information, warnings, precautions, and
instructions are not observed at all times when using the heat sealer.
• Always operate, handle, use, and maintain the heat sealer in accordance with
the safety information, warnings, precautions, instructions, and
recommended procedures provided in the user manual and other written
instructions issued by Miltenyi Biotec. Do not deviate from these operating
instructions and procedures.
• Always ensure that the heat sealer is operated, handled, used, and
maintained only by appropriately skilled and trained personnel familiar with
the construction, operation, and hazards involved with the heat sealer. The
heat sealer is intended for the use in the professional facility healthcare
environment. The heat sealer is not intended to be used near active HF
surgical equipment. The customer or user should assure that it is used in
such an environment.
• Always operate, handle, use, and maintain the heat sealer in compliance
with all applicable laws, rules, regulations and administrative provisions,
including, without limitation, all regulations regarding health and safety at
work and, as appropriate, the safety of medical devices, as applicable at the
location where the heat sealer is operated.
• Always use the heat sealer for its designated purpose (in accordance with
the product documentation and within its performance limits), and not in
any other manner or for any other purpose.
• Never use the heat sealer with consumables, accessories, transducers, and/or
cables other than those approved by Miltenyi Biotec to ensure safe and
proper operation of the heat sealer. Note: The use of consumables,
accessories, transducers, and/or cables not expressly approved by Miltenyi
Biotec could void the warranty and/or invalidate the authority to operate
this heat sealer under applicable regulations.
• Always follow the maintenance recommendations of Miltenyi Biotec and
appropriate product standards. Note: Initial installation, maintenance, and
service of the heat sealer must only be performed by authorized local
Miltenyi Biotec Service Provider.
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IMPORTANT SAFETY INFORMATION
3
• Defects should be addressed immediately. If there is any doubt regarding
the proper functioning of the heat sealer, do not use the heat sealer and
contact the authorized local Miltenyi Biotec Service Provider or Miltenyi
Biotec Technical Support as soon as possible.
• Never change or modify the heat sealer except with Miltenyi Biotec’s prior
written approval. Note: Changes or modifications to the heat sealer not
expressly approved by Miltenyi Biotec could void the warranty and/or
invalidate theoperator’s authority to operate the heat sealer under
applicable regulations.
Failure to comply with the safety information, warnings, precautions, and
instructions in the user manual (and in other safety related publications
issued by Miltenyi Biotec for use with the heat sealer) could lead to
improper or incorrect use, handling or care of the product and cause a
hazard, and could result in death, serious personal injury, and/or
property damage, heat sealer malfunction, or damage, premature wear
and tear, and reduced heat sealer life time, and may void the warranty
and/or invalidate the authority to operate the heat sealer under
applicable regulations. Miltenyi Biotec accepts no liability for
consequences arising from failure to comply with the safety information,
warnings, precautions, and instructions provided herein.
If concerned about the safe use of the heat sealer or additional safety
information regarding the CliniMACS Prodigy System is required, contact the
authorized local Miltenyi Biotec Service Provider or Miltenyi Biotec Technical
Support.
Always follow local working area safety instructions and laboratory policies, as
well as standards for health, safety, and prevention of accidents. Contact the
local authority governing electrical power supply, building constructions,
maintenance, or safety for more information about the safe installation and
operation of the heat sealer.
Electrical hazard. The heat sealer is intended for indoor use only. Water
ingress may lead to an electrical short and could result in electric shock or
spread of fire.
Do not use the heat sealer in a wet or damp location or if it has been exposed to
moisture. Avoid high humidity or condensation and protect the heat sealer from
contact with water. Do not allow fluids to enter the interior of the heat sealer. Do
not operate the heat sealer if liquids have spilled into the heat sealer. Fluid
containers must be handled with caution when in the area of the heat sealer.
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After moving the heat sealer from a cold environment, such as a cold room at
+4 °C (+39 °F), to room temperature, condensing liquid droplets may form inside
the heat sealer. It is necessary to wait for the heat sealer to dehumidify before
operating the heat sealer.
Unplug the heat sealer from the power outlet before cleaning. Do not use liquid
or aerosol cleaning agents; always use a damp cloth.
The heat sealer must be used in compliance with all specifications (see
Table 4.1) and operational procedures listed in this manual.
The heat sealer must be used by trained operators only. Operator training
will be provided by a Miltenyi Biotec Sales representative.
Follow the operating instructions while operating the heat sealer.
The heat sealer is used in the same environment as laboratory
equipment.
The heat sealer is intended for use with the CliniMACS Prodigy. Do not use
with or connect to instruments other than the CliniMACS Prodigy. If
adjacent use is necessary, the equipment or system should be observed
to verify normal operation in the configuration in which it will be used.
If any of the components of the heat sealer are exposed to blood or
biohazardous material, they must be cleaned with an appropriate
disinfectant solution (see section 4.6).
ELECTROMAGNETIC INTERFERENCE REGULATIONS:
The heat sealer emits a low level of electromagnetic (non-ionizing)
radiation during sealing. It should not be used near high-frequency
sensitive electronic equipment.
The heat sealer uses radio frequency (RF) energy to generate heat for
sealing. Never place an object other than the PVC or the EVA tubing
between the electrodes.
Medical electrical equipment needs special precautions regarding
electromagnetic compatibility (EMC) and needs to be installed and put into
service according to the EMC information. Portable and mobile RF
communications equipment can affect medical electrical equipment. For
information on electromagnetic compatibility refer to the appendix.
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IMPORTANT SAFETY INFORMATION
3
Inspect all parts of the heat sealer for the appearance of defects before use.
To guarantee safe use, only accessories delivered with the heat sealer may be
used.
If multiple seals are made along a length of tubing, the seals should be at
least 1 cm (1/2 inch) apart. Multiple seals made closer than the recommended
distance may result in rupture of the sealed tubing segment. Make three
separate seals in the tubing and cut at the middle seal. Disconnect the heat
sealer from the power source before performing any maintenance and
cleaning procedure.
In case of sealer malfunction (for example, intermittent operation, poor
quality seals, sealing time seems too long or too short), use a different heat
sealer and/or call Miltenyi Biotec Technical Support for assistance.
Periodically check the pattern of the sealing visually (see section 4.5
“Operating instructions”).
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THE MACS TUBESEALER
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MACS® TubeSealer
4.1 Regulatory information
Intended purpose
As an accessory of the CliniMACS Prodigy, the MACS® TubeSealer is intended to
seal PVC and EVA tubes of CliniMACS Prodigy Tubing Sets installed on the
CliniMACS Prodigy. The MACS TubeSealer must only be used in combination
with the CliniMACS Prodigy.
The MACS TubeSealer conforms to the Medical Device Regulation
MDR (EU) 2017/745:
The MACS TubeSealer complies with the following standards:
• IEC 60601-1 and
• IEC 60601-1-2.
For the applied standard version, refer to the respective Certificate of
Conformance.
The MACS TubeSealer 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.
IMPORTANT
Any serious incident that has occurred in relation to this product should be reported to
Miltenyi Biotec B.V. & Co. KG – using the contact information provided – and the
competent authority of the member state in which the user of this product is established
.
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4.2 Technical data
Safety and performance of the MACS TubeSealer may be compromised.
Safety and performance of the heat sealer may be compromised if it is
used outside its specifications. Do not use the heat sealer outside its
specifications.
The technical data of the heat sealer are listed in Table 4.1.
Technical data
Model MACS TubeSealer
Weight 0.35 kg
Power supply 30.5 VDC 8.3 A
RF Output Max. 80 W / 50 Ω / 40.68 MHz
Tubing specification PVC and EVA @20 °C
The heat sealer is suitable for sealing of tubing of the
CliniMACS Prodigy Tubing Sets.
Sealing time Max. 6 s depending on tubing size and type
Mode of operation Operation: 25%
Intermittens: 75%
Seal procedures 100 per hour
Continuous seal
capacity
20
Operation conditions Temperature: +15 °C (+59 °F) to +25 °C (+77 °F)
Humidity: 10 to 90% Rh (non-condensing)
Altitude: max. 2,000 meters above sea level
Storage conditions Room temperature
Avoid condensing conditions.
Table 4.1: Technical data of the MACS TubeSealer
Note: The emissions characteristics of this heat sealer 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) the heat sealer
might not offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measures, such as relocating or
reorienting the heat sealer.
Changes or modifications of the heat sealer, unless expressly approved by
Miltenyi Biotec, may void the authority to operate the heat sealer pursuant to
FCC 47 CFR.
Table of contents
