4008 S

TSC / MA report
(Version V10)

Technician's name: Customer / customer no.:

RSUD Pelabuhan Ratu

Device type including option(s) / Serial no.: Inventory no.:
software version:

12.1 9SXA0YCJ
Service report no.: Operating hours: Equipment code:

RID2208818 8599 640

No. Designation Operating state Corrected Meas. value 
1 Visual inspections
TSC 1.1 The fuse accessible from the outside corresponds to the specified Off – – 
value or seal is undamaged.
TSC 1.2 Labels and inscriptions are present and legible. Off – – 
TSC 1.3 Mechanical condition permits further safe use. No signs of damage Off – – 
or contamination affecting correct function.
TSC 1.4 Rotor(s) cleaned. Rotor(s) on the line roller pump(s) show no signs Off – – 
of damage and are fully functional. Color coding of rotor(s)
checked.
TSC 1.5 Power cable not damaged. Off – – 
2 Preventive measures
MA 2.1 Sealing plungers in suction tubes replaced and lubricated; rivets Off 
replaced.
MA 2.2 Detent rubber seal of rinse chambers checked for proper function. Off – – 
MA 2.3 Vent valve (V92), check valve (V117, with CDS option) replaced. Off – – 
MA 2.4 Filter / filter sieve replaced: Off – – 
F74 (before UF pump), F76 (after V43), F148 (between V100 and
rinse chamber), F149 (between V99 and rinse chamber), F119
(with CDS option), disinfectant filter
MA 2.5 Dialysate filter (F73) or sieve replaced. Off – – 
MA 2.6 O-rings in dialyzer couplings replaced. Off – – 
MA 2.7 Sampling valve is functional. Off – – 
MA 2.8 Fan filter replaced. Off – – 
MA 2.9 Running band and line segment of air separation pump replaced. Off – – 
MA 2.10 Only applicable when using Puristeril 340, Puristeril plus: Off – – 
Disinfectant valve V84 (yellow label) replaced.
MA 2.11 Filter (F210) replaced (if present). Off – – 
MA 2.12 bibag® connector, O-rings replaced. Off – – 
MA 2.13 There are no dirty or shabby tubes. Off – – 
MA 2.14 Interval: every second TSC / MA. Off – – 
Battery and accumulator changed.
3 General checks
TSC 3.1 Check of DIP switches PCB LP 1631 (CPU 1): Off – – 
– Without Central Delivery System:
Array 2, switch 7 is ON
– With Central Delivery System:
Array 2, switch 8 is ON

Check of DIP switches PCB LP 632 (CPU 2):

– Array 1, switch 3 is OFF
– Array 2, switch 5 is OFF
4 DIASAFE® plus
MA 4.1 DIASAFE® plus filter life checked. Off – – 
MA 4.2 Hydrophobic filter (F111) and hydrophobic filter / test valve (F184) Off – – 
replaced.
5 bibag®
MA 5.1 Switching pressure of PSW 134 checked: DIAGNOSTICS – – 
130 mbar +30 mbar
Chapter 6: Technical safety checks / maintenance procedures

No. Designation Operating state Corrected Meas. value 

6 OCM
MA 6.1 Temperature / conductivity compensation test completed. CALIBRATION – – 
7 Check of hydraulics
All pressures must be checked with undamped pressure gages!
MA 7.1 Water inlet pressure (reduced): 0.9 bar to 1.4 bar CALIBRATION – – 
MA 7.2 Degassing pressure: -0.81 bar to -0.85 bar (read Note) CALIBRATION – – 
MA 7.3 Loading pressure: 1.45 bar ±0.05 bar CALIBRATION – – 
MA 7.4 Relief pressure of balancing chamber at 800 ml/min: CALIBRATION – – 
Relief pressure: 2.2 bar ±0.05 bar
8 Ultrafiltration system and membrane pumps
TSC 8.1 UF pump checked: CALIBRATION – 
Desired value: 60 strokes = 60 ml ±0.5 ml (59.6 g ±0.5 g dialysis
water)
MA 8.2 Concentrate pump calibration: Volume removal / number of CALIBRATION – – 
strokes
MA 8.3 Bicarbonate pump calibration: Volume removal / number of strokes CALIBRATION – – 
9 Extracorporeal components
MA 9.1 Arterial pressure display checked with reference meter. CALIBRATION – – 
MA 9.2 Venous pressure display checked with reference meter. CALIBRATION – – 
TSC 9.3 Blood pumps: Check of blood pump rate (BP rate TEST) CALIBRATION – – 
TSC 9.4 Single-Needle switching pressure checked according to table. CALIBRATION – – 
10 Treatment
MA 10.1 Dialysate pressure: CALIBRATION – – 
– Zero point checked (flow off)
– Slope checked
TSC 10.2 Actual temperature (NTC3): Difference between reference CALIBRATION – °C
measuring instrument and NTC3 display ±0.2 °C checked with
reference meter.
TSC 10.3 Power failure alarm – continuous sound – text display: Power Preparation – – 
Failure
TSC 10.4 Air separation: Activation of air separation pump. Preparation – – 
Text display with further air separation and blood detected (optical
detector dark): Fillprogram
TSC 10.5 Blood pump door opened and immediate stoppage of rotor Preparation – – 
checked.
Blood pump stop alarm checked.
TSC 10.6 Venous occlusion clamp closes after blood alarm. Preparation – – 
TSC 10.7 Pressure of approx. 2 bar in venous bubble catcher. Preparation – – 
Pressure must not drop by more than 0.1 bar in 3 minutes.
TSC 10.8 Conductivity display checked with reference meter (bibag® used!). Preparation – – 
11 BPM (option)
The technical measurement checks (TMC) additionally stipulated specific to country form part of the technical
safety checks (TSC).
MA 11.1 Tube connection correctly connected to device. Off – – 
MA 11.2 Internal blood pressure module, printed circuit boards, cable Off – – 
connections properly attached.
TSC 11.3 Leakage test: Pressure leakage rate ≤ 6 mmHg/min DIAGNOSTICS – 1 
TMC
TSC 11.4 Pressure test: (pressure values / tolerance) DIAGNOSTICS – – 
TMC – 250 mmHg / ±3 mmHg 250
– 200 mmHg / ±3 mmHg
– 150 mmHg / ±3 mmHg 150
– 100 mmHg / ±3 mmHg
– 50 mmHg / ±3 mmHg
TSC 11.5 Safety valve tested. – – 
TMC System emptied by opening the safety valve. Preparation
TSC 11.6 Blood pressure measurement performed. Preparation – – 
TMC

6-4 Fresenius Medical Care 4008 S (Version V10) SM-EN 11A-2016

 Chapter 6: Technical safety checks / maintenance procedures

No. Designation Operating state Corrected Meas. value 

12 Electrical safety check
According to (DIN) EN 62353:2015, IEC 62353:2014
TSC 12.1 Visual inspections performed according to item 1. Off – – 
TSC 12.2 Protective earth resistance measured. Off – Ω 
Max. 0.3 Ω (with power cable)
TSC 12.3 Device leakage current measured. Preparation – – 
 Device leakage current – differential current measurement
according to fig. 8
or
 Device leakage current - direct measurement according to fig. 7
Nominal voltage of power supply: V – –
Device leakage current, mains polarity 1: – μA
For line voltage: – V
Normalized to nominal voltage –
(maximum 500 μA, see Additional conditions) μA
Device leakage current, mains polarity 2: – μA
For line voltage: – V
Normalized to nominal voltage –
(maximum 500 μA, see Additional conditions) μA
13 Functional test
TSC 13.1 T1 test performed T1 Test – – 
TSC 13.2 Start disinfection program. Cleaning / – – 
MA Disinfection pgm
TSC 13.3 All waste properly disposed of. Cleaning – – 
TSC/ 13.4 All documents created. Cleaning – – 
MA
TSC 13.5 Only for Puristeril 340, Puristeril plus, or Diasteril: Disinfection Cleaning – – 
MA program completed successfully. Absence of residual disinfectant
verified by means of test strips after disinfection program.

Test equipment used (type and serial number):

Comments:

Date: Signature: Stamp:

07092022
#FMESIG_6##

The device is released for its intended use  Yes

(attach inspection label).  No
Date of next check:
2023
Comments:

Date: Signature: Stamp:

07092022
#FMESIG_7##

Fresenius Medical Care 4008 S (Version V10) SM-EN 11A-2016 6-5