Fresenius Medical Care DIASAFE 2008 K User manual

FRESENIUS USA
2008K HEMODIALYSIS SYSTEM
TECHNICIAN’S
MANUAL
Part Number 490049 Rev A
FRESENIUS USA
2637 SHADELANDS DRIVE
WALNUT CREEK, CALIF. 94598
[phone]
[phone]
Copyright  2000 Fresenius USA, Inc.

2008K Technician’s Manual i
TABLE OF CONTENTS
ISPECIFICATIONS
II GENERAL WARNINGS AND CAUTIONS
III HYDRAULIC DESCRIPTION
IV ELECTRONIC CIRCUIT DESCRIPTION
VMODULE DESCRIPTION
VI CALIBRATION AND INSTALLATION PROCEDURES
VII TROUBLESHOOTING
VIII MAINTENANCE

SECTION I
SPECIFICATIONS

Section I – Specifications
2008K Technician’s Manual I-1
SPECIFICATIONS
2008K HEMODIALYSIS MACHINE
Dimensions
Floor space Approximately 54 cm wide by 63 cm deep
Height 133 cm
Total weight Approximately 73 kg
Electrical
Power Supply—Main Single phase AC 120 V ±10% 60 Hz ±3 Hz must be
connected to a circuit which is equipped with a hospital
grade receptacle and is protected by circuit breaker and
ground fault circuit interrupter (GFCI). Resistance from
chassis to ground must be < 0.2 ohm.
Power Consumption Does not exceed 12.5 amps
Fuses 6.3 amp medium blow fuse, 2 each
16 amp double pole rocker switch circuit breaker for
heater
External Connections A. Alarm output normally open and normally closed
switch contacts reflecting alarm state. 24 V, 0.2
amp max.
B. Alarm input
C. External alarm light or traffic light beacon
Isolated RS232 and leakage current isolation per UL 544
between the machine and external computer
Heat Dissipation to Room 600 to 700 BTU/hr.

Section I – Specifications
I-22008K Technician’s Manual
Water
Back Flow Prevention Integral back flow prevention provided by external vent
to atmosphere in water inlet circuit.
Water Pressure Min 20 psi; max 105 psi
Water Temperature Min 10 °C; max 25 °C
Quality AAMI Standard, RD5, 1992
Drain 3 feet maximum height. Must comply with local codes
and must maintain a free fall air gap between drain hose
and building drain.
Rinsing Temperature 37° C. Flow rate 620 ml/min. Time between
10 and 60 minutes (internally selectable)
Concentrate Supply
Concentrate Pressure Max suction height 3 feet
Max supplied pressure 2 psi
Dialysate Flow
Adjustment Range Sequential (0)/100/200/300/400/500/600/700/800 ml/ min., selectable in the Dialysis screen;
Dialysate on/off key
Partial Dialysate Collection From Drain line, intermittent collection using a 3 Liter
PD drain bag as a collection device with a Safe-Lock
connector (optional).
Proportional Mixing System
Acid Volumetric, selectable:
1:34
1:44
1:35.83
1:35.1
Acetate 1:34
Adjustment Range 130 to 155 mEq/L Na+
Bicarbonate Volumetric, selected with associated acid ratio
1:27.6
1:19.1
1:24.5
1:28.6

Section I – Specifications
2008K Technician’s Manual I-3
Concentrate Supply (cont.)
Adjustment Range 20 to 40 mEq/L Bicarbonate
Monitoring Conductivity Temperature compensated conductivity display with
automatically set alarm windows ±0.5 mS/cm around
calculated conductivity. User can adjust an additional
±0.5mS/cm within this range. Conductivity is based on
the concentrates’ compositional data entered in the
Dialysate screen at the standard temperature of 25°C.
Range of Display 10.0 to 17.0 mS/cm corrected to 25° C. Alarm limits will
not go below 13.0 or above 16.0 mS/cm.
Dialysate Heating
Nominal Value of Temperature
Temperature Display
35 to 39° C, ( selectable in 0.1 ° C steps )
Range 35 to 39° C with alarm limit window
automatically adjusted to 2° C above and below set point.
Alarm window will not go below 30° or above 41° C.
Heater 1.3 kW, electronically controlled.
Heat Disinfection
Temperature 83 ±8° C at NTC 3
Flow Rate 600 ml/min.
Pre-rinse either 7min. @ 600ml/min or 20min. @
300ml/min. (user selectable)
Time Between 10 and 60 minutes (internally selectable)
Chemical Disinfection
Temperature 37° C (set point applicable)
Flow Rate 620 ml/min.
Time Between 10 and 60 minutes (internally selectable)
Blood Pump
Display of flow rate 20 to 600 ml/min, depending on pump segment ID.
Internal diameter of pump segment 2 to 10 mm (0.08" to 0.4")
Tube length 32 cm minimum (12-5/8")
Level adjust Up only
Power outage use The pump can be manually operated with a hand crank.

Section I – Specifications
I-42008K Technician’s Manual
Single Needle System
Two Pump Procedure With two blood pumps, pressure control system with
alternating blood pumps. Alarm after 15 or 30 seconds
without an alternation of the pumps.
Heparin Pump
Type of Syringe 10 - 12 ml disposable syringe
Administration Rate 0.1 to 9.9 ml/hr
Monitoring Monitoring end of stroke
Bolus From 0.1 to 9.9 ml volume
Monitoring Elements: Blood Circuit
Arterial Pressure Monitor -300 to +500 mmHg with 3 automatically set time-delayed
alarm window limit values (±60, ±80, and ±100 mmHg of
actual pressure. (Single Needle ±80mmhg).
Venous Pressure Monitor -80 to +500 mmHg with 3 fixed window limit values of
+60, ±80, and ±100 mmHg of actual pressure. There is also
an asymmetric range initially set to ±80 mmHg which
increases the lower limit after 60 seconds. (Single Needle
+80 mmHg).
TMP Monitor +60 to -520 mmHg with automatically set time delayed
window limit values of ±60 (conventional dialysis) and
±40 mmHg (high flux dialysis). Compensation for upward
drift.
Level detector Ultrasonic impulses detect fluid level in the venous drip
chamber.
Optical Sensor Optical transmission used to detect opaque or non-opaque
presence in the blood tubing.
Clamp Closes with any blood alarm to protect patient
Venous Level Adjust Allows the fluid level in the venous drip chamber to be
raised or lowered
Arterial Level Adjust Allows the fluid level in the arterial drip chamber to be
raised
Blood Leak Detector Two color light source transmitter / sensor with a
resolution of:
minor >0.35 ml/min. of blood (hematocrit = 25%)
alarm >0.45 ml/min. of blood (hematocrit = 25%)

Section I – Specifications
2008K Technician’s Manual I-5
Ultrafiltration Control
Adjustment Range of UF Rate Volumetric Control, 0-4000 ml/hr.
1000, 2000, 3000, and 4000 ml/hr. internally maximum
rate. Adjusted in 10 ml increments.
UF Time Digital Display (0 – 9:59 hrs.) Selectable in increments
of 1 min.
UF Goal Digital Display (0 to 9,990 ml). Selectable in increments
of 10 ml.
UF Profiles Eight UF profiles (4 preset & 4 user settable) are
available for the removal of excess fluid from the
patient.
Remaining Time of Dialysis (RTD) 0-9:59 hours auto transfer from UF time, counting down
in 1-minute increments. Can adjust manually.
UF Removed Display Digital display max 9,999 ml counting in 1 ml
increments.
Additional Monitoring Alarm in case of power failure.
Functional Options
Online Clearance A means of estimating urea clearance during treatment
by measuring conductivity responses after brief
alterations in dialysate concentration.
Sodium Variation System (SVS) A means for temporarily increasing the sodium
concentration at the beginning of dialysis for patient
comfort.
Sodium Variation Profiles Three preset profiles (step, linear, and exponential) for
increasing, then decreasing the sodium concentration in
dialysate.
Blood Temperature Monitor (BTM)
(Optional) A means of temperature control for the patient and for evaluating adequacy of access flow by measuring
temperature changes in the arterial and venous lines after
temporary excursions in the dialysate temperature.
DiaSafeA means of filtering the dialysate to reduce
bacteriological exposure

Section I – Specifications
I-62008K Technician’s Manual
Blood Pressure Module
Technique Measures systolic, diastolic pressures, and heart rate
(pulse rate) using oscillometric method. MAP measured.
Cuff Deflation Interactive computer controlled. Determination for
adults requires approximately 25-30 seconds depending
on starting point, heart rate and motion artifact.
Cuff Inflation Typically 5 - 10 seconds from 0-250 mmHg.
Performance Limits
Pediatric Adult
Cuff Pressure Range 5-220 mmHg 10-325 mmHg
Initial Cuff Inflation 125 mmHg or adjustable 180 mmHg or adjustable
Systolic Determination Range 40-160 mmHg 80-260 mmHg
MAP Determination Range 25-140 mmHg 35-220 mmHg
Diastolic Determination Range 15-120 mmHg 25-200 mmHg
Pulse Rate Determination Range 40-240 BPM 40-180 BPM
Cuff Inflation Rate 5 seconds 5 seconds
Determination Time Normal Approx. 20 seconds 25-30 seconds
Overpressure Cut Off 220 mmHg 325 mmHg
Transducer Drift Auto Zeroing Auto Zeroing
Leakage Rate (Max) 3 mmHg in 4 minutes 3 mmHg in 4 minutes
Pressure Rate Offset Auto Zeroing Auto Zeroing
Alarm Preset Values (Internal alarm values
preset to provide alarm limits in the event
individual values are not entered)
Pediatric/Neonatal Adult
Systolic 160/80 200/90
MAP 120/70 120/70
Diastolic 100/60 110/50
Pulse 120/50 120/50
Inflation Pressure Auto Auto

Section I – Specifications
2008K Technician’s Manual I-7
PRODUCT IMPROVEMENT POLICY
The Fresenius 2008K Dialysis System was designed and built to comply with these specifications. It
is the intention of Fresenius USA to continuously do product development which may result in
modifications and improvements to specifications or equipment produced in the future. Such
product improvements shall not incur any obligation to make similar changes or improvements to
equipment previously produced. These changes or improvements may or may not be applicable or
usable with previously produced equipment. Where possible, improvements will be made available
at reasonable prices. Any such improvements shall not be construed as corrections of any
deficiency.
In order to properly calibrate and maintain the 2008K Dialysis System, the documentation being
used must be up to date. The current revision of a document can be obtained through the Fresenius
Customer Service department at 800-227-2572.