II.2 Características particulares del proyecto
II.2.7 Residuos
Check the zero point according to Chapter 9:
Calibration / Adjustment (see Part 14.1: Dialysate pressure, page 9-33). With the dialysate circuit open, the water level must be
approx. 10 cm above the shunt interlock.
Re 9.1 Zero point checked (flow off)
Operating condition: CALIBRATION
Re 9.2 Slope checked
Operating condition: CALIBRATION
Re 10 Checking extracorporeal components
Re 10.1 Blood pumps: Check the blood pump rate.
Operating condition: CALIBRATION / BP-Rate CHECK
Re 10.2 Operating condition: CALIBRATION
Check the changeover points according to table (see chapter 11.2.1.25, page 11-25).
Re 10.3 Blood pump stop alarm checked.
Operating condition: CALIBRATION
Opening of the blood pump cover initiates a BP stop alarm after 30 sec (factory setting).
Re 10.4 Venous line clamp closes after blood alarm.
Operating condition: CALIBRATION
The venous tube clamp must close in the event of blood alarm.
Re 10.5 Pressure of approx. 2 bar in the venous bubble catcher.
Operating condition: CALIBRATION
The pressure may not drop by more than 0.1 bar within 3 minutes. Generate a pressure of approx. 2 bar in the venous bubble catcher. The pressure may not drop by more than 0.1 bar within 3 minutes (see chapter 9.3.1.3, page 9-51).
Re 11 Setup settings (PC Service program)
Re 11.1 Make Setup settings in the Service program and transfer data to the
4008S dialysis device. The dialysis device is in calibration mode / CALIBRATION.
Operating condition: CALIBRATION
Re 11.4 Print setup data.
Operating condition: CALIBRATION
Re 12 Checking the electrical safety
Electrical safety
According to (DIN) EN 62353: 2008, IEC 62353: 2007
Re 12.1 Visual inspection performed according to item 1 (Preparation).
Operating condition: Off
– Fuses accessible from the outside comply with the indicated values. – Labels and identifications are present and legible.
– The mechanical condition permits further safe use. – No damage or contaminations detectable.
– Power cable not damaged.
Re 12.2 Measure protective earth resistance.
Max. 0.3Ω (with power cable) Operating condition: Off
The protective earth resistance must be checked on the following measurement points.
Measurement point: power supply unit (power supply unit housing)
Re 12.3 Measure leakage current (device leakage current).
Operating condition: Dialysis mode
Differential current measurement according to figure 5
Direct measurement according to fig. 4
Basic conditions:
– Measurement of the protective earth resistance performed. – Perform the measurement with the hemodialysis device being at
operating temperature. – Dialysate:
Dialysis temperature: ≥ 37 °C Dialysate flow:≥ 300 ml/min Conductivity:≥ 13 mS/cm
– When performing a direct measurement, the following precautions also must be observed:
The device must be insulated when installed.
All external connections must have been removed from the device. The line voltage during the measurement will be recorded, as well as the maximum device leakage current, scaled to the nominal voltage of the power supply. Maximum device leakage current: 500 µA
Example:
Line voltage during measurement: 225 V Device leakage current:
mains polarity 1: 180 µA mains polarity 2: 120 µA
Maximum value of both mains polarities: 180 µA Nominal voltage of power supply: 230 V
Scaled to nominal voltage 184 µA (180 µA: 225 V x 230 V = 184 µA Device leakage current < 500 µA: OK Additional requirements:
If the value scaled to the nominal voltage is higher than 90 % of the admissible alarm limit (= 450 µA), the last measured value or the first measured value must additionally be considered for the rating.
If the device leakage current has considerably increased since the last measurement or has continuously increased since the first
measurement (slow deterioration of the insulation), or if the sum composed of the current value plus the difference since the last measurement is > 500 µA, the measurement has not been passed. Example 1:
Example 2:
Device leakage current: 470 µA Last measured value: 390 µA
470 + (470 – 390) = 470 + 80 = 550; not passed
Re 13 Functional test
Re 13.1 T1 test performed
Operating condition: dialysis mode
Perform additional checks only after completion of the T1 test. T1 test passed without errors.
Re 14 Final check
Re 14.1 Power failure alarm – continuous sound – text displayed: Emergency
operation
Operating condition: dialysis mode
Re 14.2 Activation of air separation of degassing pump
Operating condition: dialysis mode
Text display with further air separation and OD senses opaque: Fill program
Re 14.3 Set temperature at a desired value of 37 °C (36.8 to 37.2 °C)
Operating condition: dialysis mode
Re 14.4 Expected conductivity value
Operating condition: dialysis mode
Compare the conductivity displayed on the monitor with the specifications on the acid / concentrate container.
Re 14.5 Run the disinfection program.
Operating condition: cleaning / disinfection
Re 14.6 Make entries in the medical device register.
Operating condition: Off
Re 14.7 Operating Instructions and accessories package complete and match
the device.
Operating condition: Off
Re 14.8 Attach TSC inspection label.
Comments:
Use this section to note down any irregularities which occurred during the check.
Date, signature, stamp
Performance of the check must be confirmed with the date, the signature of the person performing the check and a stamp.
Assessing the test The device has been released for further use. Attach inspection label.
It must be ensured that the intended use of the device will not present a hazard to patients, operators and other third parties.
Within the scope of the overall assessment, the tester must make a definite decision whether the device may be used or not. The
responsible organization must immediately be informed of any defects detected.
Date of next inspection:
The next inspection date has to be entered in the report.
The intervals specified by the manufacturer have to be observed.
Comments:
Use this section to note down any irregularities which occurred during the assessment.
Date, signature, stamp:
Assessment of the initial start-up has to be confirmed with date, tester's signature and stamp.
3.4
Decommissioning / removal from service / recommissioning
3.4.1
Decommissioning
3.4.2
Removal from service
3.4.3
Recommissioning
4
Specifications
4.1
Dimensions and weight
Dimensions Height: approx. 137 cm (without IV pole) Width: approx. 48 cm
Depth: approx. 48 cm (without housing footing) Base: approx. 48 x 63 cm2
Weight Approx. 86 kg (without options)
4.2
Type label (identification of the device)
The type label shown is only an example. The decisive criterion is the data specified on the type label of the device .
1 Identification of electric and electronic devices
2 Connection values
3 Protection against ingress of liquids: drip-proof
4 Caution: consult accompanying documents
5 EC: Equipment Code
6 Degree of protection against electrical shock: type B
4.3
Electrical safety
Electrical safety (classification according to EN 60601-1, IEC 601-1)
Type of protection against electrical shock
Safety class I
Degree of protection against electric shock
type B
Degree of protection against ingress of liquids
drip-proof
Leakage currents According to EN 60601-1
4.4
Electrical supply
Line voltage 100 V AC, ±10 %, 47 to 63 Hz, 16 A 110 V AC, ±10 %, 47 to 63 Hz, 15 A 120 V AC, ±10 %, 47 to 63 Hz, 14 A 127 V AC, ±10 %, 47 to 63 Hz, 14 A 220 V AC, ±10 %, 47 to 63 Hz, 9 A 230 V AC, ±10 %, 47 to 63 Hz, 9 A 240 V AC, ±10 %, 47 to 63 Hz, 9 A
The decisive criterion is the line voltage and the operating current specified on the type label of the device.
Power supply (internal)
+5 V, +0.3 V short-circuit-proof +12 V, +0.4 V, short-circuit-proof +24 V, ±0.7 V, short-circuit-proof
Battery Lead-acid battery (maintenance-free)
18 V (= 3 x 6 V) / 3 Ah