Fresenius Medical Care AquaA, Instructions For Use Manual

Page: 227 / 240

Chapter 15: Appendix
Fresenius Medical Care AquaA IFU-EN-US 06B-2021 227
Documentation, maintenance
A Operational data acquisition
(see chapter 4.10.5.1 on
page 83)
– Date and time when the data was collected
– Permeate conductivity CD-P
– Permeate temperature T-P
– Inlet conductivity CD-F
– Inlet temperature T-F
– Permeate pressure P-P
– Concentrate pressure P-C
– Feed flow FL-F
– Diversion FL-C
– Permeate consumption
– Daily consumption
– Efficiency (desired)
– Efficiency (current)
– Rejection rate IFU,
ODR

B Operational data acquisition
AquaA2 (see chapter 4.10.5.2
on page 87) - Date and time
when the data was collected
– Permeate conductivity CD-Ps
– Permeate temperature T-Ps
– Feed pressure P-Fs
– Permeate pressure P-Ps
– Concentrate pressure P-Cs
– Feed flow FL-Fs
– Diversion FL-Cs
– Daily consumption
– Rejection rate IFU, TD

C Report of heat disinfections
(see chapter 4.10.2.3 on
page 74)
– Start of the heat disinfection program
– Duration of the heat disinfection program
– Type of heat disinfection program
– Temp 1: Temperature 1 reached
– Temp 2: Temperature 2 reached
– Consumption: Dialysis water consumption from the
AquaHT tank during heat
disinfection.
– A0: The A0 value achieved during heat disinfection
IFU, TD

D Maintenance (staff) (see
chapter 11.2 on page 155)
– Refill softener salt
– Check for leakage
– Soft water sample
– Replace the filter cartridges IFU

E Report on the most recent
activities (see chapter 4.10.2.4
on page 75)
– SUPPLY : Last start of SUPPLY mode
–
RINSE
: Last start of
RINSE
mode. This includes rinsing of the
AquaA
as well as the
RINSE-Water pretreatment
.
– CHEMICAL DISINFECTION : Last start of a chemical disinfection.
– DECALCIFICATION : Last start of a decalcification.
– ALKALINE CLEANING : Last start of an alkaline cleaning.
– RING MAIN HEAT DISINFECTION : Last start of a ring main heat disinfection. This
activity is only displayed when using an AquaHT .
– MODULE HEAT DISINFECTION : Last start of a module heat disinfection. This
activity is only displayed when using an AquaHT .
IFU

Miscellaneous
A Various items (see
chapter 15.7.3 on page 239),
(see chapter 8.1 on
page 142), (see chapter 15.1
on page 219), (see
chapter 11.1 on page 155)
– Collection of microbiological samples
– Ordering accessories (filter, salt)
– Medical Device Register
– Intervals for Technical Safety checks IFU, TD

IFU = Instructions for Use
ODR = Operational data acquisition report
TD = Training documentation
Reference to the Instructions for Use:
The device has been approved for use with the consumables, accessories and options listed in the Instructions for Use. Should the responsible
organization wish to use consumables, accessories or options other than those listed in the Instructions for Use, the responsibility to ensure
the correct function of the device lies exclusively with the responsible organization.
Trainer
Name
Date, signature
Training subjects Filed in
