B. Braun Aquaboss CCS, Инструкция по эксплуатации

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Medical product log Aquaboss
®
CCS
Section 2 – Operating Instructions
Rev. 2.8 Date 2019-02-04
Software version 1.00
CCS
Chapter 7
Page 7-5
The system was taken over in perfect working order
10. Safety markings
Replaced Carried out /
OK
Last replacement
month / year
Values / data / remarks R V
10.1 Existing markings and lettering checked for
damaged and replaced if necessary  
X X
11. Inspection of the earthing equipment
connections
Replaced Carried out /
OK
Last replacement
month / year
Values / data / remarks R V
11.1 Earth terminal fitted tightly to rail
 
X X
11.2 Clamps on earth terminal tightened  
X X
11.3 Earthing bolts for door tightened
 
X X
11.4 Earthing bolts for mounting plate tightened  
X X
11.5 Earthing bolts for housing tightened
 
X X
12. Junction boxes
Replaced Carried out /
OK
Last replacement
month / year
Values / data / remarks R V
12.1 Tighten all clamps on junction box FU1  
X X
12.2 Tighten all clamps on junction box FU2  
X X
12.3 Tighten all clamps on junction box FU3  
X X
13. Repeat test for electric medical devices in accordance
with DIN EN 62353 (IEC 62353)
Values / data / remarks W V
Test equipment number:
Test executed in accordance with DIN EN 62353 (IEC 62353)
13.1 Visual inspection:
Mains connection cable, complete system: 
OK

n.OK
13.2 Protective conductor resistance: Measured value Limit value
13.3 Measurement between mains connection cable and housing R
SL
< 0,300

X
13.4 Measurement between mains connection cable and mounting plate R
SL
< 0,300

X
13.5 Measurement between mains connection cable and door/front plate R
SL
< 0,300

X
13.6 Measurement between mains connection cable and
ground connection of concentrate pipe
R
SL
< 0,300

X
13.7 Insulation resistance:
Gauge all conductive parts that can be touched R
ISO
> 2,0 M

X
13.8 Leakage current:
Equivalent leakage current: I
EGA
< 1,0 mA
X
Functional test
Measuring protocol available
Executed 
OK

n.OK

OK

n.OK

OK

n.OK
ATTENTION
14. Handover Carried out /
OK
R V
14.1 Start dialysis / standby operating mode 
X
14.2 Attach test label 
X X
Next STK due at the latest: (MM/YY)

STK + certificate: The CCS has been checked for correct functionality. The CCS is safe to operate under the conditions of proper use.
................................................................................................. .................................................................................................
Service technician, block letters City / date, signature
................................................................................................. .................................................................................................
System operator, block letters City / date, signature