B. Braun Aquaboss CCS User manual

Instructions for use
CCS
Concentrate supply
Rev. 2.8 Date 2019-02-04
Software version 1.00
Art. no.: LA53591_EN_BAV

Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Instructions
Notes on operating instructions

Notes on operating instructions
Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Instructions
Dear customer,
If you have any difficulties with the system that cannot be solved with the aid of these operating instruc-
tions, please contact B. Braun directly, your nearest service technician or authorised B. Braun partner with
as precise a description of the fault as possible, and always have the system data on hand.
These operating instructions must always be kept on the site where the water treatment system is
installed.
The operating instructions contain basic instructions which must be heeded before operation and mainte-
nance. For this reason, they must be read by the fitter and specialist staff/operator responsible before the
system is put into operation. In addition, they must always be available for reference on site.
The system operator is obliged to heed the working, maintenance and technical safety check processes
described in these operating instructions and their respective intervals.
If these operating instructions are not followed, B. Braun cannot guarantee safe system operation.
B. Braun reserves the right to alter sections of these operating instructions or technical data without prior
notice.
If you have any questions about these operating instructions or would like to send us your comments or
suggestions for improvement, please do not hesitate to contact us directly.
B. Braun Avitum AG
Schwarzenberger Weg 73-79
34212 Melsungen
Germany
Tel.: [phone]
Fax: [phone]
www.bbraun.com
Your personal service
______________________________
Name
is on 24h standby duty and can be contacted by phone at:
______________________________

Rev. 2.8 Date 2019-02-04
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CCS
Instructions
Notes on operating instructions
Suggestions for improvement
When you are working with these operating instructions, you may have an idea that could contribute to
improving the contents. Please do not keep this idea to yourself; let us have your suggestions. This will
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Please include further pages if necessary. You can also include pages you have copied from the
operating instructions and improved by adding comments.
Please send your suggestions to:
B. Braun Avitum AG
Schwarzenberger Weg 73-79
34212 Melsungen
Germany
Fax: [phone]

Notes on operating instructions
Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Instructions
Notes on operating instructions
The operating instructions contain information regarding the safe use of the system.
The user must convince himself of the correct function and proper state of the medical product before put-
ting it to use, and heed the operating instructions and other information and maintenance instructions
enclosed.
The operator is to be instructed on the following points and committed to observe them:
• The user must undertake to operate the system only in proper condition. The system must not be
used or applied if there are any faults that could cause harm to patients, employees or third parties.
The user must ensure that the devices function and are in proper condition prior to any use.
• The operator is to be instructed on hazards, rules of behaviour and any safety measures necessary
when dealing with the substances used, instructed on what to do in the event of an emergency and
in first aid.
• The operator is to be instructed on the permissible operating data (e.g. setting data for safety and
monitoring systems, functional tests).
• The operator is to be instructed on system servicing, routine check and elimination or irregularities
in operation.
• The operator is to be instructed on safe procedures handling the products. This includes theoretical
principles, proper handling and conditions for application.
• Using instructions and tests, the operator must provide for cleanness and orderliness where the
product is used.
• The operator is obliged to regulate the responsibilities during commissioning, operation and servicing
quite clearly so that these are met by everyone, so that there is no confusion about expertise from
a safety point of view.
• The medical product may only be operated according to its intended purpose in accordance with the
regulations of the current German medical product operator ordinance.
• The medical product may only be set up, operated and used by people who have the required training
or knowledge and experience.
• The user is obliged to inform his superior/the operator immediately as to any changes on the system
that affect safety and to observe all the safety instructions.

Rev. 2.8 Date 2019-02-04
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Instructions
Notes on operating instructions
Signs and symbols used in the operating instructions
Signs and symbols used at the control cabinet
DANGER The signal word indicates a high-risk hazard which, if not avoided, will cause death or
severe injury.
WARNING The signal word indicates a medium-risk hazard which, if not avoided, will cause death or
severe injury.
CAUTION The signal word indicates a low-risk hazard which, if not avoided, will cause death or
severe injury.
ATTENTION
The signal word warns of material and environmental damage.
NOTE The signal word points to suggestions / details on the economical use or just to a simpler
work step.
→This symbol indicates a cross reference to a chapter within these operating instructions.
Protective earth connection
Ground connection
Observe the operating instructions
OFF (power supply, disconnect from mains supply)
ON (power supply, connect with mains supply)
Dangerous voltage
Note: residual risks. Refer to the requirement to obtain safety-related information
in the user manual.
The medical device manufacturer displays in accordance with the EU 90/385/EEC,
93/42/EEC and 98/79/EU Directives.
It shows the date on which the medical device was manufactured.
It shows the manufacturer’s item number, so that a specific medical device can be
identified.
It shows the manufacturer’s serial number, so that a specific medical device can be
identified.
A symbol for temperature limits. This shows the temperature limit values between
which the medical device can be safely exposed.

Notes on operating instructions
Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Instructions
General Warnings, Important, Notice
DANGER Electrical shock
Dangerous voltage when control cabinet is open.
→Switch off the device at the main switch and unplug from the mains.
WARNING Hemodialysis concentrate can irritate the skin. It is not suitable for consumption. In the
event of skin or mucous membrane irritation, rinse thoroughly with water and consult
a physician.
WARNING If the system is at a standstill unexpectedly, the user should not change to a different
operating status immediately. Someone could have brought the system to a standstill for
manual intervention and forgotten to secure it against being switched back on. Unexpected
switch-on can lead to serious injuries.
WARNING In order to prevent patient hazards, maintenance, STK or service work should be done
during dialysis-free times.
WARNING Component failure if one does not conduct the maintenance and safety technical
inspections!
Stoppage of the concentrate supply and therefore no supply and distribution of
haemodialysis concentrates possible.
→Non-adherence to the manufacturer’s maintenance instructions could lead to
a functional impact on the system.
→An annual safety inspection (STK) is prescribed by B. Braun-authorized experts.
WARNING Danger of poisoning by released construction materials, and hazard to patients due to
system failure.
→After maintenance, repair, exchange of components or other changes, the operator must
provide documented evidence that the system corresponds to the original specifications
(such as material compatibility).
CAUTION The concentrates to be pumped must be free of crystalline soiling and precipitates.
CAUTION Incorrect commissioning of the system can lead to damage to the system and personal
injury.
ATTENTION
The use of other accessories, cables or transformers with the CCS device lead to an
increase in jamming and a reduction in noise immunity.
ATTENTION
The user must ensure that the devices function and are in the proper condition before using
the combination of devices.

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Instructions
Notes on operating instructions
ATTENTION
It must be ensured that additional equipment that is connected to the analogue and digital
interfaces of the device satisfies the appropriate EN specifications (e.g. EN 60950 for data
processing devices, EN 61010-1 for measuring/control/laboratory devices and EN 60601-1
for electro-medical devices). Furthermore, all configuration must satisfy the valid version of
EN 60601-1-1. The person who connects additional equipment to the signal input or output
sections is a system configurator and is therefore responsible for ensuring that the valid
version of system standard EN 60601-1-1 is observed. If you have any questions, please
contact your local dealer of the Technical Services department.
ATTENTION
Medical devices which are directly or indirectly connected (ring leads, haemodialysis
devices) must be secure against 5 bars pressure.
ATTENTION
The choice of concentrate mixing equipment for dialysis is the responsibility of the dialysis
physician.
To prevent idling of the connected ring piping, a check valve must be installed either in the
concentrate mixing system or in the ring piping.
ATTENTION
The input of incorrect values may impair the proper functioning of the control or the
operational safety of the system.
Settings must be carried out only by authorised technical staff.
ATTENTION
During venting, the pressure in the supply line can move above the normal operating
pressure. To protect any pressure devices connected from possible damage, they have to
be disconnected before venting.
ATTENTION
Care must be taken that the hydraulic part of the system can be installed under the minimum
tank level.
ATTENTION
The CCS is an electrical medical device. Special EMC safety measures are necessary and
the system must be installed in line with the EMC information provided in this instruction
booklet.
NOTE Only original parts from B. Braun may be used. B. Braun does not accept any liability for
damage caused by spare parts, consumables or accessories that are not original B. Braun
parts.
NOTE Residual risks remain despite the measures taken to avoid such risks.
NOTE The intended use is the pumping and distribution of liquid acid hemodialysis concentrates.
NOTE The devices of the CCS series are medical electrical equipment which is subject to special
safety measures with regard to EMC and must be installed and put into operation in
accordance with the instructions in Section 2, Chapter 6.
Portable and mobile HF communication equipment can influence medical electrical
equipment.
The devices of the CCS series must not be stacked or used directly next to or with other
devices. If this is necessary, the equipment must be observed in order to check proper
operation in this arrangement.
NOTE The Aquaboss central concentrate supply is designed for safe operation in combination with
Aquaboss®products (ring leads, reverse osmosis system).

Notes on operating instructions
Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Instructions
NOTE The materials used meet the requirements of the DIRECTIVE 2011/65/EU OF THE EUROPEAN
PARLIAMENT AND THE COUNCIL of 8 June 2011 on the restriction of the use of certain
hazardous substances in electrical and electronic equipment (ROHS).
NOTE The operating hours remain saved even when the EPROM is replaced.
NOTE An error message overwrites an alarm message. The first error message is retained even
if further “errors” are established.
NOTE Only have experienced transport specialists carry out transportation.
NOTE Initial system switch-on must be carried out by trained specialists.
NOTE The system may only be commissioned by trained and skilled personnel or by a trained
representative authorized by B. Braun.
When handling liquid haemodialysis concentrates, it is mandatory to refer to the
manufacturer's safety provisions!
NOTE Only original spare parts, accessories and consumables from B. Braun are to be used
→Section 2, page 8-1 and →Section 1, page 3-1.
B. Braun does not accept liability for damage caused by the use of other spare
parts, accessories and consumables.
NOTE Portable and mobile HF communication equipment can influence lectrical medical
equipment.
NOTE The EMC test is carried out under the condition that the important performance features
are fulfilled without alarms being generated which are defined in the software specification
V1.00 Rev. 00, paragraph 7.
NOTE No frequencies other than those specified in EN 60601-1-2 Ed. 4, have been tested.

Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Instructions
Notes on operating instructions

Notes on operating instructions
Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Instructions
These operating instructions comprise two sections:
Section 1 – Operating Instructions
Here you will find subjects important for normal operation of the system.
1. Safety
2. Area of application and intended use
3. Accessories List
4. Use in combination with other equipment
5. Return and disposal
6. Function and Modes of Operation
7. Operation
8. System data parameters
9. Faults / Causes / Correction
Section 2 – Supplementary Operating Instructions
Here you will find the essential instructions for commissioning the system, routine check
and technical safety system checks.
1. Handover declaration for the operating instructions
2. Transport and setup
3. Work prior to commissioning
4. Initial commissioning
5. System key data
6. Technical data
7. Medical product log Aquaboss®CCS
8. Spare parts list

Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Instructions
Notes on operating instructions

Notes on operating instructions
Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Instructions

Contents
Section 1 – Operating Instructions
Rev. 2.8 Date 2019-02-04
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Section 1
Page 1
Section 1 – Operating Instructions
1. Safety..................................................................................... 1-1
1.1 General safety ................................................................................................ 1-1
1.2 Safety during repair, servicing and maintenance ....................................... 1-1
1.2.1 Operational safety ............................................................................................ 1-1
1.2.2 Functional safety .............................................................................................. 1-1
1.2.3 Risks due to non-observance of safety instructions ......................................... 1-2
1.2.4 Impermissible operating modes ....................................................................... 1-2
1.3 Microbiological safety.................................................................................... 1-2
1.4 Residual risks ................................................................................................. 1-2
1.5 Cleaning .......................................................................................................... 1-2
2. Area of application and intended use................................. 2-1
2.1 Operational features ...................................................................................... 2-1
2.2 Important performance features................................................................... 2-1
2.3 Application regulations ................................................................................. 2-1
2.4 Contraindications and side effects............................................................... 2-2
2.4.1 Contraindications ............................................................................................. 2-2
2.4.2 Side effects ...................................................................................................... 2-2
3. Accessories List ................................................................... 3-1
4. Use in combination with other equipment ......................... 4-1
5. Return and disposal ............................................................. 5-1
6. Function and Modes of Operation ...................................... 6-1
6.1 General............................................................................................................ 6-1
6.1.1 CCS with hydraulic part and supply via pump(s).............................................. 6-1
6.1.2 Set-up / Basic Function .................................................................................... 6-2
6.1.3 Turning the system on...................................................................................... 6-3
6.1.4 CPU watchdog ................................................................................................. 6-3
6.1.5 Power pack watchdog ...................................................................................... 6-3

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Contents
Section 1 – Operating Instructions
6.2 Modes of operation ........................................................................................ 6-3
6.2.1 System OFF ..................................................................................................... 6-3
6.2.2 Manual mode ................................................................................................... 6-3
6.2.3 Automatic mode ............................................................................................... 6-3
6.3 Venting ............................................................................................................ 6-3
6.4 Economy mode............................................................................................... 6-3
6.5 Pressure regulation........................................................................................ 6-4
6.5.1 Switch-on monitoring........................................................................................ 6-4
6.5.2 Pump start-up................................................................................................... 6-4
6.5.3 Pressure regulator............................................................................................ 6-4
6.6 Container replacement .................................................................................. 6-4
7. Operation............................................................................... 7-1
7.1 Display and keyboard .................................................................................... 7-1
8. System data parameters ...................................................... 8-1
8.1 Menu structure ............................................................................................... 8-1
8.2 Langauge, menu item 0 ................................................................................. 8-2
8.3 Entering the date/time, menu item 1............................................................. 8-2
8.4 Input of automatic on/off, menu item 2 ........................................................ 8-2
8.5 Container reset, menu item 3 ........................................................................ 8-3
8.6 Pressure alarm reset, menu item 4............................................................... 8-3
8.7 Service interval, menu item 5........................................................................ 8-3
8.8 System data, menu item 6 ............................................................................. 8-4
8.8.1 Display of system data, menu 6A display......................................................... 8-4
8.8.2 System data menu 6B Program ....................................................................... 8-6
8.9 Maintenance program, menu item 7 ............................................................. 8-7
8.9.1 Maintenance program, setting outputs ............................................................. 8-7
8.9.2 Maintenance program, observing inputs .......................................................... 8-7
8.9.3 Maintenance program, venting......................................................................... 8-8
8.10 Fault history, menu item 8............................................................................. 8-9
9. Faults / Causes / Correction ................................................ 9-1
9.1 Fault messages .............................................................................................. 9-1
9.1.1 Types of faults .................................................................................................. 9-1

Safety
Section 1 – Operating Instructions
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Chapter 1
Page 1-1
1. Safety
1.1 General safety
The Aquaboss® Central Concentrate Supply CCS, abbreviated to CCS below, has been designed accord-
ing to the latest technical standards and is fail-safe.
Improper or irregular use can put the operating personnel at risk. Therefore, the following is applicable:
• Read and carefully observe these operating instructions, especially the safety instructions.
• Keep the operating instructions near the CCS.
• Commissioning, operation and routine check is only to be carried out by authorized, trained and
B. Braun-instructed skilled workers. Electrical work is to be carried out only by authorized, trained and
instructed electricians.
• Without exception, all local safety and accident prevention regulations are applicable for operating the
system. These regulations must be observed and maintained at all times.
• Please observe instruction and warning signs.
• Consult a doctor immediately in the case of injuries, accidents or inflammation of the skin.
1.2 Safety during repair, servicing and maintenance
1.2.1 Operational safety
• If the product to be processed is damaging to the health, contact should be avoided. If contact does
occur, first-aid must be carried out on the premises.
• Do not modify, remove, bypass or bridge safety devices.
• Do not allow the pumps to run dry!
1.2.2 Functional safety
When the housing is opened:
Maintenance and repair work may only be carried out by authorized specialists.
WARNING Hemodialysis concentrate can irritate the skin. It is not suitable for consumption. In the
event of skin or mucous membrane irritation, rinse thoroughly with water and consult
a physician.
WARNING If the system is at a standstill unexpectedly, the user should not change to a different
operating status immediately. Someone could have brought the system to a standstill for
manual intervention and forgotten to secure it against being switched back on. Unexpected
switch-on can lead to serious injuries.
WARNING In order to prevent patient hazards, maintenance, STK or service work should be done
during dialysis-free times.
DANGER Electrical shock
Dangerous voltage when control cabinet is open.
→Switch off the device at the main switch and unplug from the mains.
NOTE Only original parts from B. Braun may be used. B. Braun does not accept any liability for
damage caused by spare parts, consumables or accessories that are not original B. Braun
parts.

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Chapter 1
Safety
Section 1 – Operating Instructions
1.2.3 Risks due to non-observance of safety instructions
Non-observance of safety instructions can lead to danger for the user and/or the patient. Non-observance
can lead to the following dangers, for example:
• Failure of important system functions
• Failure of prescribed maintenance methods
• Danger to persons through electrical and mechanical means
1.2.4 Impermissible operating modes
The operational safety of the system delivered is only guaranteed when the system is used for the
intended purpose. The values specified in the technical data must be kept, limit values must never
be exceeded.
1.3 Microbiological safety
Acid concentrates have a low risk of contamination. Nevertheless, connection between the devices
and the central concentrate supply must be made under defined hygienic conditions and be described
in the hygiene plan.
When central concentrate systems are used (acid concentrates), examination of the system for the
presence of fungi/micro-organisms is recommended once a year. If fungi/micro-organisms are found,
B. Braun recommends consultation with the manufacturer to agree further measures.
1.4 Residual risks
Residual risks are potential hazards which are not apparent, e.g.:
• Hazard that could arise from the product or medium, such as allergies or skin irritations.
• Hazard arising from faults in the control.
• Hazard arising from misconduct of the operator
1. Electric shock
The concentrate supply system CCS is operated with an electric voltage of 100–240 V.
Improper opening of the control cabinet or damage to the electrical supply cables can trigger an
electric shock (danger to life!).
Any work at the system that requires opening of the control cabinet or touching the connection cables,
must only be carried out when the system is switched off (main switch to "0") and with the mains power
disconnected.
If the CCS is equipped with a fixed connection, the upstream disconnection mechanism must be used
to completely separate the system from the mains power.. Supply cables, terminals and mains filter
against electromagnetic interference are installed upstream of the mains switch (1) of the CCS.
2. Leakage
In case of leakage acidic haemodialysis concentrate may escape. There is the risk of skin irrigations
and chemical burns caused by acidic haemodialysis concentrate.
1.5 Cleaning
• Cleaning with usual commercial surfactant cleaners and with water
• Loosen concentrate remnants with water
• The surfaces can be cleaned and disinfected with normal surface disinfectants
• Do not use any solvent-containing cleaners
NOTE Residual risks remain despite the measures taken to avoid such risks.

Area of application and intended use
Section 1 – Operating Instructions
Rev. 2.8 Date 2019-02-04
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Chapter 2
Page 2-1
2. Area of application and intended use
The operator is responsible for the proper operation of the system.
The Aquaboss Central Concentrate Supply CCS may only be used for the intended purpose and is
designed for a lifetime of 10 years.
2.1 Operational features
The central concentrate supply pumps up to 3 different acid hemodialysis concentrates on up to two floors.
The pumps are speed-regulated in order to meet the maximum pressure requirements at the point of
transition specified by the manufacturer.
2.2 Important performance features
Pumping of acid hemodialysis concentrates to the user without having a negative influence on their
physical, chemical or micro-biological characteristics.
The Aquaboss central concentrate supply has a short period of application as per the 93/42/EEC
Appendix IX Directive (<30 days).
2.3 Application regulations
Only liquid, acid hemodialysis concentrates (acid concentrate, A-concentrate ISO 13958) may be pumped.
• Intended use also includes observance of the commissioning, operating and maintenance instructions
provided by the manufacturer, which are an integral part of these instructions.
• The system may only be transported, installed, used and repaired by skilled workers.
• Commissioning, operation and routine check is only to be carried out by authorized, trained and
instructed skilled workers.
• Any other use of the system is considered as non-intended use. The manufacturer shall not be liable
for any damage resulting from this.
NOTE The intended use is the pumping and distribution of liquid acid hemodialysis concentrates.
NOTE The devices of the CCS series are medical electrical equipment which is subject to special
safety measures with regard to EMC and must be installed and put into operation in
accordance with the instructions in →Section 2, chapter 6.2.3.
Portable and mobile HF communication equipment can influence medical electrical
equipment.
The devices of the CCS series must not be stacked or used directly next to or with other
devices. If this is necessary, the equipment must be observed in order to check proper
operation in this arrangement.
CAUTION The concentrates to be pumped must be free of crystalline soiling and precipitates.

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Chapter 2
Area of application and intended use
Section 1 – Operating Instructions
2.4 Contraindications and side effects
2.4.1 Contraindications
The CCS may not be used:
• at expired expiry date of the connected concentrate container.
• in case of unclear chemical or microbiological quality of the concentrate.
• if the concentrates to be pumped do not comply with ISO 13958.
2.4.2 Side effects
Not known.

Accessories List
Section 1 – Operating Instructions
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Chapter 3
Page 3-1
3. Accessories List
Pos. Description Item no.
1 Control CCS
Remote control
2000300
2 Control CCS
Remote control
2000200
3 Process visualisation
Basic licence
Hardware extension
Individual licence CCS
2000100
1050170
2001060
4 Bumper guard 9500206
5 Suction and float lance for
barrel operation
93579
ATTENTION
The use of other accessories, cables or transformers with the CCS device lead to an
increase in jamming and a reduction in noise immunity.