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Chapter 6: Technical Safety Checks / maintenance procedures

TSC/MA report AquaBplus


Customer number/customer name: Inventory number:
Tester’s name: Operating hours:
Software version: Equipment code:
Service report number: Serial number:
Cat. No. Description Operating Measured value/ /NA
state correction
Information:  = successful inspection item / NA = non-applicable inspection item
Options installed:
AquaBplus B2 – –  /
AquaBplus HF – –  /
AquaBplus UF – –  /
RingBase – –  /
RingUnit / wall-mounted inlet unit Number of ring mains:  /
Housing – –  /
Emergency mode – –  /
Fluid Fly Loop – –  /
Set units 
a) bar, L/h, °C, m, °dH – – 
b) psi, gal/h, °F, ft, ppm CaCO3 – – 
1 Tests/measures conducted with device switched off
TSC 1.1 Power supply cord checked for signs of damage. Off – 
TSC 1.2 Externally accessible fuse checked for specified rating. Seal checked for signs Off – 
of damage, where applicable.
TSC 1.3 Presence and legibility of labels and inscriptions checked. Off – 
TSC 1.4 Device checked for damage and contamination. Off – 
Target value: The device’s mechanical condition allows continued safe use of
the device as intended.
MA 1.5 The control cabinet seal of the AquaBplus HFshows no signs of damage. Off – 
Testing the feed water
TSC 1.6 Activated carbon filter: Total chlorine checked at outlet. Off / 
Target value: Total chlorine < 0.1 mg/l mg/L / ppm
TSC 1.7 Softener: Soft water checked at outlet. Off / 
Target value: Hardness < 1° dH °dH/ppm CaCO3
MA 1.8 SDI checked at outlet. Off /  /
Target value: SDI < 3
2 Electrical safety check following (DIN) EN 62353:2015, IEC 62353:2014,
Information: Turn the device off.
Note: AquaBplus must be permanently connected.
TSC 2.1 Protective earth resistance measured and checked. Off / Ω 
Target value: ≤ 0.3 Ω with power supply cord
3 Operating parameters
Information: Switch on the device.
TSC 3.1 Legibility of the display checked. STANDBY – 
TSC 3.2 Setting values checked. STANDBY – 
TSC 3.3 Configuration checked. On – 
TSC 3.4 Message memory checked. On – 
4 Checking the sensors
TSC 4.1 Permeate conductivity (CD-P) checked. SUPPLY / µS/cm 
TSC 4.2 Soft water conductivity (CD-F) checked. SUPPLY / µS/cm 
TSC 4.3 Permeate temperature (T-P) checked. SUPPLY / °C / °F 
TSC 4.4 Soft water temperature (T-F) checked. SUPPLY / °C / °F 
TSC 4.5 Concentrate pressure (P-C) checked. SUPPLY / bar/psi 
TSC 4.6 Check and evaluation of permeate conductivity (conductivity at final stage): SUPPLY – 
1 Measured values: – 
Permeate conductivity CD-Pcurrent / µS/cm 
Yield / % 
Soft water conductivity CD-Fcurrent / µS/cm 
2 First measured values (scaled): – 
Permeate conductivity CD-P0 / µS/cm 
Soft water conductivity CD-F0 / µS/cm 
Rejection rate R / % 

6-2 Fresenius Medical Care AquaBplus SM-EN 9A-2019


Chapter 6: Technical Safety Checks / maintenance procedures

Service report number: Serial number:


Cat. No. Description Operating Measured value/ /NA
state correction
5 Checking the functions
TSC 5.1 Permeate pressure measured externally. SUPPLY – 
Target value: Last supply ports ≥ 2.0 bar.
TSC 5.2 External alarm system checked. SUPPLY – 
TSC 5.3 Leakage sensor checked. SUPPLY – 
TSC 5.4 Emergency mode checked. SUPPLY – 
Testing options
AquaBplus B2 option  /
Note: AquaBplus B2 must be permanently connected.
TSC 5.5 Protective earth resistance, maximum 0.3 Ω (with power supply cord). Off / Ω 
TSC 5.6 Permeate conductivity (CD-Ps) checked. SUPPLY / µS/cm 
TSC 5.7 Permeate temperature (T-Ps) checked. SUPPLY / °C / °F 
TSC 5.8 Concentrate pressure (P-Cs) checked. SUPPLY / bar/psi 
AquaBplus HF option  /
Note: AquaBplus HF must be permanently connected.
TSC 5.9 Protective earth resistance, maximum 0.3 Ω (with power supply cord). Off / Ω 
TSC 5.10 Temperature (T-Hin) checked (compared with T-P). SUPPLY / °C / °F 
TSC 5.11 Temperature (T-Hout) checked (compared with T-P). SUPPLY / °C / °F 
TSC 5.12 Temperature (T-sup) checked (compared with T-P). SUPPLY / °C / °F 
TSC 5.13 Heat disinfection performed without any errors and recorded accordingly. Heat / A 
– Flow heaters checked for correct function. disinfection
RingBase option  /
TSC 5.14 Permeate stop valve (V22) checked. SUPPLY – 
Tank control option  /
TSC 5.15 Tank sensors checked. SUPPLY – 
TSC 5.16 Tank fill valve checked. SUPPLY – 
AquaBplus UF option  /
TSC 5.17 Rinse valves checked. RINSE – 
Fluid Fly Loop option  /
TSC 5.18 Fluid Fly Loop shows no signs of mechanical damage. Off – 
TSC 5.19 The integrated cable clamp is functional. Off – 
TSC 5.20 The sampling valve (if present) is functional. Off – 
TSC 5.21 The device connection shows no signs of damage. Off – 
TSC 5.22 Fluid Fly Loop checked for leaks. Off – 
Basic remote control option  /
TSC 5.23 Start button pressed. System switches to SUPPLY. STANDBY – 
TSC 5.24 Stop button pressed. System switches to STANDBY. SUPPLY – 
TSC 5.25 Failure checked. On – 
6 Final tasks
TSC 6.1 Procedure recorded on the machine record and in the Medical Device Register. STANDBY –  /
TSC 6.2 All waste properly disposed of. STANDBY – 
TSC 6.3 All documents completed. STANDBY – 
Confirmation of the inspection
Service report number: Serial number:
Test equipment used (type and serial number):

Inspection comments:

Date of inspection: Tester’s signature: Tester’s stamp:

#FMESIG_3##

Assessment of the inspection


The device is released for its intended use.  Yes  No Date of next inspection:
The inspection label has been attached to the device.
Assessment comments:

Date of assessment: Signature of representative of the responsible Stamp of the responsible organization:
organization:

#FMESIG_4##

Fresenius Medical Care AquaBplus SM-EN 9A-2019 6-3

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