Rev. 4.00 December 2014
Software version 1.04
Part 2 • Page 8-6
Maintenance and operating logs
Part 2 – Supplementary Operating Instructions
EcoRO Dia I/II (HT)
Part 2 • Chapter 8
8.4
DISINFECTION LOG (reference to document E07FB02)
Execution:
1.
Instruct the person responsible about disinfection
2.
Disconnect the dialysis machine
3.
Clearly mark that the system is being disinfected
4.
Check Hydrowatch: red indicator is not visible
5.
Carry out cleaning using program mode “C” and the cleaning log
6.
Carry out disinfection using program mode “DI” or “D”
Disinfection carried out on the following:
Disinfectant used:
1.
After disinfection (DI), the reverse osmosis system (RO) and the loop must be flushed out with permeate
2.
Specific check for residual disinfectant for:
• H
2
O
2
(peroxide test – Merck item no. 10011)
or
• Peroxyacetic acid (peroxyacetic acid test – Merck item no. 110084) or
• Chlorine (chlorine test – Merck item no. 117925)
1.
Separate check on all permeate tapping points to make sure there is no disinfectant left in the system
2.
Repeated check to ensure there is no disinfectant left in the system after the disinfected and rinsed RO has stood still for 30 min.
I have made sure that the check for residual disinfectant is negative at all tapping points
Analysis:
Overall germ count according to Ph. Eur issue 5, chap. 1167 resp. EDTNA Guidelines issue 4: setpoint < 100/ml endotoxin using LAL test: setpoint < 0.25
EU/ml
Sampling:
•
Use sterile disposable gloves
•
Clean sampling cock (at least loop feed and return) with alcohol
•
Open the sampling cock and rinse constantly for about 3–5 min.
•
Fill permeate sample into a sterile sampling vessel (at least 200 ml), close it immediately or filtrate it using a sampling filter (item no. 50346) with
sampling nipple (item no. 50327) (note the water quantity!).
•
Store the sample in a cool place and pass it on to an accredited research lab within 6 hours
End of disinfection:
.........................
Signature customer: ...............................................
Place/date
.........................
Signature technician:..............................................
Customer
Street
Postal code and city
Disinfection ordered by
on
Disinfection initiated by
on
IMPORTANT The warning and safety instructions of the operating manual must always be followed!
Reverse osmosis system
No.:
Loop
Tapping points permeate/sampling
Expiry date
Quantity
Concentration
Circulating time
Reaction time
Flushing time
NOTICE
It is guaranteed that a test to prove there is no residual disinfectant in the system will be car-
ried out at all tapping points before the next dialysis begins.
NOTICE
To prove effective disinfection, a determination of bacterial count in the permeate is recom-
mended within 5–7 days of disinfection
