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HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:1
Program version 10.xx
Performance and specification - Control
System
Note
• When accuracy ranges are written as e.g. “(±1 ml/min or
±1%)” the widest range is valid.
• For the qualified technician, the Service Manual for the
AK 200 ULTRA S dialysis machine is available. The Service
Manual provides all the necessary information for the safe and
required maintenance of the machine.
Note
Double Needle
8:2 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx
Air Detection
Heparin Administration
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:3
Program version 10.xx
Dialysis fluid preparation
Temperature
Fluid flow
Conductivity
Concentration
Concentrates
pH supervision
8:4 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx
Degassing
Fluid flow
Ultrafiltration control
Constant TMP in on-line mode, where TMP for AK 200 ULTRA S dial-
ysis machine is defined as the difference, Pb out - Pd out, where Pb out
is the venous drip chamber pressure and Pd out is the pressure measured
in the dialysis fluid, where it enters the machine after the dialyzer.
Substitution fluid
Substitution fluid flow rate 0.3 to 27.0 litres/h (±10%) at 500 ml/min
flow rate. Limitations at lower flow rates.
Substitution volume max. 150 litres
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:5
Program version 10.xx
Profiling
UF-rate 0 to 4 l/h
Na+, Acetate mode 115 to 160 mmol/l
Na+, Bicarbonate mode 130 to 150 mmol/l
HCO3-, Bicarbonate mode 20 to 40 mmol/l
Half-times:
Diascan
Accuracy is valid in HD double needle and on-line HDF postdilution,
for blood flows 200 to 500 ml/min and fluid flows 500 to 700 ml/min,
UF profiling is allowed.
8:6 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx
Disinfection and Cleaning
Temperature and time in different phases and concentration of
disinfectant are possible to preset. The values in this specification are
the default values and what the machine has been validated against.
Follow the instructions from the manufacturer of the disinfectant, to set
the correct dilution and dwell time. All disinfection programs in the
AK 200 ULTRA S dialysis machine are tested in accordance with the
French standard NFS 90-304 and established to fulfil the requirements
expressed in the same standard. Time for disinfection programs is
estimated and may vary.
All values below are applicable for the 230V AC variant. For the 115V
AC variant add 7 minutes to all heating programs.
Temperature 93 °C
Fill up phase 13 minutes
Circulation phase 15 minutes
Drain phase 4 minutes
Total time 32 minutes
Decalcification CleanCart-C
Cleaning CleanCart-A
Temperature 93 °C
Fill up and mixing phase 13 minutes
Circulation phase 15 minutes
Rinse/Drain phase 15 minutes
Total time 39 minutes
Temperature 93 °C
Concentration 20 % citric acid
Concentration in machine 2 % citric acid; i.e. diluted 1 + 9
Consumption Approx. 260 ml
Fill up and mixing phase 19 minutes
Circulation phase 15 minutes
Rinse/Drain phase 10 minutes
Total time 44 minutes
Temperature 93 °C
Fill up phase 13 minutes
Circulation phase 15 minutes
Low flow heat phase 20 minutes
Drain phase 4 minutes
Total time 52 minutes
Decalcification CleanCart-C
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:7
Program version 10.xx
Cleaning CleanCart-A
Temperature 93 °C
Fill up phase 13 minutes
Circulation phase 15 minutes
Low flow heat phase 20 minutes
Rinse/Drain phase 11 minutes
Total time 59 minutes
8:8 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx
Peracetic Acid Program
Hypochlorite Program
Formaldehyde Program
Concentration of 4% formaldehyde
disinfectant
Concentration in machine 4% ; i.e. not diluted
Consumption Approx. 3000 ml
Fill up and mixing phase 25 minutes
Dwell time 20 minutes
Rinse/Drain phase 67 minutes
Total time 108 minutes including 20 min dwell time
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:9
Program version 10.xx
Other programs, total time
8:10 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx
Water supply
Drain
Power supply
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:11
Program version 10.xx
Connection of external equipment
External equipment intended for connection to signal input, signal
output or other connectors, shall comply with relevant IEC standard
(e.g. IEC 60950 for IT equipment and the IEC 60601 series for medical
electrical equipment). In addition, all such combinations - systems -
shall comply with the standard IEC 60601-1-1, Safety requirements
for medical electrical systems. Equipment not complying to IEC
60601 shall be kept outside the patient environment, as defined in the
standard. (The normal distance can be mentioned i.e. at least 1.5 m
from the patient or the patient support.) Any person who connects
external equipment to signal input, signal output or other connectors
has formed a system and is therefore responsible for the system to
comply with the requirements of IEC 60601-1-1. If in doubt, contact
qualified technician or your local representative. Use of other cables
may result in increased emissions or decreased immunity for the
equipment or system. Protective caps shall be attached when the
connectors are not in use.
8:12 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx
External serial interface
RS-232
RS-422
External interface
External interface
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:13
Program version 10.xx
Battery Back-up
8:14 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx
Performance and specification -
Supervisory system
Note
• When accuracy ranges are written as e.g. “(±1 ml/min or
±1%)” the widest range is valid.
Note
Venous Pressure
Arterial Pressure
System Pressure
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:15
Program version 10.xx
Air Detection
Heparin Administration
Temperature
Conductivity
8:16 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx
Ultrafiltration
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:17
Program version 10.xx
Physical data
References
Assembly Drawing: K22200
8:18 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx
Materials in contact with water,
concentrates and dialysis fluid
Polymers
Silicon rubber
Santroprene
PVC (Polyvinylchloride)
PEEK (Polyetherketone)
PEX (Polyethylene)
PP (Polypropylene)
PP (Polypropylene reinforced with talcum)
PSU (Polysulphone)
PVDF (Polyvinylidene fluoride)
PTFE (Polytetrafluoro ethylene)
Metals
Stainless steel SS2343
Stainless steel SS2353
Stainless steel SS2562
Titanium
Platinum
Others
Carbon
Ceramic, Steatite 221
Ceramic, Aluminium oxide (Al2O3)
Ceramic, Zirconium oxide (ZrO2)
Glass
Ferrite (Barium-Strontium- Ferrit)
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:19
Program version 10.xx
Environmental data
Operation
If condensation occur when moving the equipment between locations
with different temperatures and high relative humidity (e.g. outdoor
and indoor locations), the inside of the equipment shall be allowed to
dry before switching on the equipment.
Electromagnetic environment
The AK 200 ULTRA S dialysis machine is intended for use in the
electromagnetic environment specified below. The customer or the
user of the AK 200 ULTRA S dialysis machine should assure that it
is used in such an environment.
8:20 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx
Immunity test IEC 60601 Compliance level Electromagnetic enviroment-guidance
test level
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or
discharge (ESD), ±8 kV Air ±8 kV Air ceramic tile. If floors are covered with
IEC 61000-4-2 synthetic material, the relative humidity
should be at least 30 %.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that
transient/burst, lines lines of a typical commercial or hospital
IEC 61000-4-4 ±1kV for ±1kV for environment.
input/output lines input/output lines
Surge ±1kV for ±1kV for Mains power quality should be that
IEC 61000-4-5 differential mode differential mode of a typical commercial or hospital
±2kV for ±2kV for common environment
common mode mode
Voltage <5 % UT <5 % UT Mains power quality should be that
dips, short (>95 % dip in UT) (>95 % dip in UT) of a typical commercial or hospital
interruptions for 0,5 cycle for 0,5 cycle environment. If the user of the
and voltage 40 % UT 40 % UT AK 200 ULTRA S dialysis machine
variations on (60 % dip in UT) (60 % dip in UT) requires continued operation during power
power supply for 5 cycles for 5 cycles mains interruptions, it is recommended
input lines. 70 % UT 70 % UT that the AK 200 ULTRA S dialysis
IEC 61000-4-11 (30 % dip in UT) (30 % dip in UT) machine be powered from an
for 25 cycles for 25 cycles uninterruptible power supply or a
<5 % UT <5 % UT battery.
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should
(50/60 Hz) be at levels characteristic of a typical
magnetic field location in a typical commercial or
IEC 61000-4-8 hospital environment.
Note
• UT is the a.c. mains voltage prior to application of the test level.
Note
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:21
Program version 10.xx
Immunity test IEC 60601 Compliance level Electromagnetic enviroment-guidance
test level
Portable and mobile RF communications
equipment should be used no closer to
any part of the AK 200 ULTRA S dialysis
machine, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3V d = 1.2 P
IEC 61000-4-6 150 kHz to 80
MHz
Radiated RF 3 V/m 3 V/m d = 1.2 P 80 MHz to 800
IEC 61000-4-3 80 MHz to 2,5
d = 2.3 P 800 MHz to 2,5 GHz
GHz
Radiated RF - 30V/m where P is the maximum output power
mobile phones rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic
site survey2, should be less than the
compliance level in each frequency
range3.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Note
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Note
2 Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in
the location in which the AK 200 ULTRA S dialysis machine is used exceeds the
applicable RF compliance level above, the AK 200 ULTRA S dialysis machine
should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating
the AK 200 ULTRA S dialysis machine.
3 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m.
8:22 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx
Recommended separation distances between portable and mobile RF communications equipment
and the AK 200 ULTRA S dialysis machine
The AK 200 ULTRA S dialysis machine is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the AK 200 ULTRA S dialysis
machine can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the AK 200 ULTRA S dialysis
machine as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of (m)
transmitter
W
150kHz - 80MHz 80MHz - 800MHz 800MHz - 2500MHz
⎡ 3,5 ⎤ ⎡ 3,5 ⎤ ⎡7⎤
d =⎢ ⎥ P d =⎢ ⎥ P d=⎢ ⎥ P
⎣ 3⎦ ⎣ 3⎦ ⎣ 3⎦
100 12 12 23
Rated maximum - - ⎡7⎤
d=⎢ ⎥ P
output power of ⎣ 30 ⎦
mobile phone
2W - - 0.33
GSM/3G
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
Note
• At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
• These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Note
零件名称 有毒有害物质或元素
Part Name Toxic or hazardous Substances and Elements
铅 汞 镉 六价铬 多溴联苯 多溴二苯醚
Lead Mercury Cadmium Hexavalent Polybrominated Polybrominated
(Pb) (Hg) (Cd) Chromium (CR biphenyls (PBB) diphenyl ethers
(VI)) (PBDE)
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:23
Program version 10.xx
电路板组件
Printed Circuit X O O O O O
Board Assemblies
电气元件以及 电
缆线材
Electromechanical X O O O O O
Components
including wiring
电源组件
X O O O O O
Power Supply
电池元件
X O O O O O
Batteries
金属件
O O O O O O
Metals
塑料件
O O O O O O
Plastics
外壳
O O O O O O
Enclosures
O: 表示该有毒有害物质在该部件所有均质材料中的含量均在SJ/T11363-2006标准规定的限量要求以下.
O: Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is below the
limit requirement in SJ/T11363-2006.
X: 表示该有毒有害物质至少在该部件的某一均质材料中的含量超出SJ/T11363-2006标准规定的限量要求.
X: Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for this
part is above the limit requirement in SJ/T11363- 2006.
8:24 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx
Standards
The machine complies with the following standards:
HCEN9297 Revision 02.2010 Tech. data and specifications - AK 200 ULTRA S 8:25
Program version 10.xx
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8:26 Tech. data and specifications - AK 200 ULTRA S HCEN9297 Revision 02.2010
Program version 10.xx