Вы находитесь на странице: 1из 24

Chapter 7

Technical data and specifications -


AK 200 S
Contents

Performance and specification - Control System . . . . . . . . . . . . . . . . . 7:2


Blood Flow Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:2
Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:3
Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:3
Blood Volume Sensor (BVS) . . . . . . . . . . . . . . . . . . . . . . . . . . 7:3
Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . 7:3
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:4
Dialysis fluid preparation (BiCart Select mode only) . . . . . . . . 7:5
Ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5
Substitution fluid (Low volume HDF) . . . . . . . . . . . . . . . . . . . . 7:5
Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:5
Diascan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:6
Disinfection and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:6
Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:9
Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:10
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:10
Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . 7:10
Battery Back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:12
Performance and specification - Supervisory system . . . . . . . . . . . . . . 7:13
Blood Pressure Supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:13
Air Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:14
Heparin Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:14
Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:14
Dialysis fluid preparation (BiCart Select mode only) . . . . . . . . 7:14
Ultrafiltration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:15
Substitution fluid (Low volume HDF) . . . . . . . . . . . . . . . . . . . . 7:15
Blood leak detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:15
Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:16
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:16
Materials in contact with water, concentrates and dialysis fluid . . . . . . 7:17
Polymers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:17
Metals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:17
Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:17
Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:18
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:18
Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:18
Electromagnetic environment . . . . . . . . . . . . . . . . . . . . . . . . . . 7:18
China RoHS declaration table according to SJ/T 11363–2006 . . 7:21
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7:23

HCEN9287 Revision 02.2010 Tech. data and specifications - AK 200 S 7:1


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 S dialysis machine is available. The Service Manual
provides all the necessary information for the safe and required
maintenance of the machine.
Note

Blood Flow Control


Values for the blood pump(s) are based on the arterial blood pump with
a pump segment of 7.9 mm and 2.0 mm wall thickness. For paediatric
blood tubes with pump segment of 4.0 mm it is also possible to set
blood flow to 10 or 15 ml/min. Accuracy is then ±5 ml/min.

Double Needle

Blood Flows in HD, single 20 to 500 ml/min (±10 ml/min or ±15%)


pump:
Blood Flows in Low 20 to 500 ml/min (±10 ml/min or ±15%)
volume HDF:
Accumulated blood 0 to 327 litres (±0.6 l * treatment time (h)
volume: or ±15%)

Single Needle Single Pump

Arterial flow: 20 to 500 ml/min (±10 ml/min or ±18%)


Time control: 2 to 20 sec (±1 sec), Arterial and venous
time. The actual clamp opening time is
depending on blood flow rate, size of
expansion chamber and pressure limits.
Pressure control: 10 to 600 mmHg (±50 mmHg), venous
pressure control
Accumulated blood 0 to 327 litres (±0.6 l * treatment time (h)
volume: or ±18%)

Single Needle Double Pump (HD only)

Double pump-A 20 to 800 ml/min


Double pump-V 20 to 800 ml/min
Mean Flow-SN/DP 10 to 400 ml/min (±10 ml or ±15%)
Accumulated blood volume 0 to 99.9 litres (±0.6 l * treatment time
(h) or ±15%)
Stroke Volume-SN/DP 20 to 60 ml/stroke (±15%) at a cycle time
< 20 s

7:2 Tech. data and specifications - AK 200 S HCEN9287 Revision 02.2010


Program version 10.xx
Air Detection

Sensitivity Bubbles larger than 1 μl will be trapped


by the drip chamber. An alarm will be
issued if the blood level falls below the
middle of the air detector.
Venous drip chamber size 22 mm
(diameter)

Heparin Administration

Heparinization 0/0.5 to 10 ml/h (±1 ml or 0.2 ml *


heparinization time (h) or ±5%)
Stop time, can be preset 0 to 4.00 h.min (±1 min) (20 min)
(Default)
Syringe size, can be preset 10 to 30 ml (30 ml)
(Default)
Maximum counter pressure +650 mmHg
The accuracy is based on tests with 20 ml and 30 ml syringes

Blood Volume Sensor (BVS)

Relative blood volume - 40% to + 10% from reference value


∆BV (Standard deviation ±3%) Sensor active
for Hb ≥ 80 g/l and blood flow ≥180
ml/min

Blood Pressure Monitor (BPM)


The alarm limits below can be preset. The value put in brackets and in
italics is the default value.

Systolic pressure range1 60 - 250 mmHg


Low alarm limit 60 - 250 mmHg (100 mmHg)
High alarm limit 60 - 250 mmHg (150 mmHg)
Diastolic pressure range1 40 - 200 mmHg
Low alarm limit 40 - 200 mmHg (40 mmHg)
High alarm limit 40 - 200 mmHg (100 mmHg)
Mean pressure range1 45 - 235 mmHg
Low alarm limit 45 - 235 mmHg (75 mmHg)
High alarm limit 45 - 235 mmHg (115 mmHg)
Pulse rate range 40 - 200 bpm (±2 bpm or ±2 % of
reading)
Low alarm limit 40 - 180 bpm (40 bpm)
High alarm limit 40 - 180 bpm (150 bpm)

1 Meets ANSI/AAMI SP-10 (1992). Mean error ±5 mmHg. Standard deviation


8 mmHg

HCEN9287 Revision 02.2010 Tech. data and specifications - AK 200 S 7:3


Program version 10.xx
Dialysis fluid preparation

Temperature

Dialysis Fluid Temperature 30-39 °C (+0,5/-1,5 °C) (+0,5/-2,0 °C)


with UFD-kit at fluid flow < 500 ml/min.
Accuracy is valid only if dialysis fluid
temperature is greater or equal to ambient
temperature.
Temperature low alarm, can 28 to 40 °C (35°)
be preset (Default)
Temperature high alarm, 28 to 40 °C (39°)
can be preset (Default)

Fluid flow

Dialysis Fluid Flow Rate 300 to 700 ml/min (±10 ml/min)

Conductivity

Conductivity measuring 0.1 - 20 mS/cm (±0.1 mS/cm)


Alarm limits in Acetate ±5 % of set value
mode
Alarm limit in Bicarbonate ±5% of set value for A-step conductivity
mode, A-step
Alarm Limit in Bicarbonate ±5% of set value for B-step conductivity
mode, B-step
Alarm limits are extended to 10% for maximum 2 minutes of 10
minutes

Concentration

Na+, Acetate mode 115 to 160 mmol/l (±4 mmol/l)


Na+, Bicarbonate mode 130 to 150 mmol/l (±6 mmol/l)
HCO3-, Bicarbonate mode 20 to 40 mmol/l (±6 mmol/l)

Concentrates

Max. pressure for +50 kPa


concentrates

pH supervision

pH measurement of 1 to 9.9 pH units (±0,2 pH units for


Dialysis Fluid pH 5 to 9, ±0,5 pH units for pH<5 or
pH>9)
pH low alarm, can be preset 1 to 15 pH units (6 Acetate mode, 6.5
(Default) Bicarb mode)
pH high alarm, can be 1 to 15 pH units (8 Acetate mode, 7.8
preset (Default) Bicarb mode)

7:4 Tech. data and specifications - AK 200 S HCEN9287 Revision 02.2010


Program version 10.xx
Degassing

Degassing pressure in -700 to -500 mmHg (±30 mmHg) (-630


Acetate mode, can be preset mmHg) Minimum 75 mmHg absolute
(Default) pressure
Degassing pressure in -700 to -500 mmHg (±30 mmHg) (-580
Bicarbonate mode, can be mmHg) Minimum 75 mmHg absolute
preset (Default) pressure

Dialysis fluid preparation (BiCart Select mode only)

Fluid flow

SelectBag Proportioning 1:400 (±3%)


Ratio SelectBag Proportioning Ratio is defined
as the quotient SelectBag flow/dialysis
fluid flow

Ultrafiltration control

UF volume max. 30 litres (±50 ml or ±50 ml * passed


treatment time (h) or ±2.5%)
UF-rate 0.0 to 4.0 l/h
Treatment Time 0.05 to 9.59 hour.minute (±1 minute)

Substitution fluid (Low volume HDF)

Substitution fluid flow rate 1.0 to 2.0 l/h (±10%)

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:

Degressive Set in h.min, 10 to 25% of remaining


treatment time
Progressive Set in h.min, 75 to 90% of remaining
treatment time

HCEN9287 Revision 02.2010 Tech. data and specifications - AK 200 S 7:5


Program version 10.xx
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.

Clearance, K 0 to 350 ml/min (±10%)


Cumulated water volume 0 to 100 l (±10%)
cleared of urea, Kt
Dialysis dose, Kt/V 0 to 3 (±10%)
Plasma sodium, Na+ 130 to 160 mmol/l

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 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 5 minutes to all heating programs. For the 115V AC S
UFD variant add 7 minutes to all heating programs.

Heat disinfection Program

Temperature 93 °C
Fill up phase 10 minutes (13 minutes with UFD-kit,
(optional))
Circulation phase 15 minutes
Drain phase 4 minutes
Total time 29 minutes (32 minutes with UFD-kit,
(optional))

Heat disinfection Program with CleanCart

Decalcification CleanCart-C
Cleaning CleanCart-A
Temperature 93 °C
Fill up and mixing phase 12 minutes (13 minutes with UFD-kit,
(optional))
Circulation phase 15 minutes
Rinse/Drain phase 5 minutes (11 minutes with UFD-kit,
(optional))
Total time 32 minutes (39 minutes with UFD-kit,
(optional))

7:6 Tech. data and specifications - AK 200 S HCEN9287 Revision 02.2010


Program version 10.xx
Heat disinfection Program with liquid citric acid

Temperature 93 °C
Concentration 20 % citric acid
Concentration in machine 2 % citric acid; i.e. diluted 1 + 9
Consumption Approx. 200 ml
(Approx. 230 ml with UFD-kit,
(optional))
Fill up and mixing phase 15 minutes
(18 minutes with UFD-kit, (optional))
Circulation phase 15 minutes
Rinse/Drain phase 12 minutes
(11minutes with UFD-kit, (optional))
Total time 40 minutes
(43 minutes with UFD-kit, (optional))

Heat disinfection Program with WRO 300 H

Temperature 93 °C
Fill up phase 10 minutes (13 minutes with UFD-kit,
(optional))
Circulation phase 15 minutes
Low flow heat phase 20 minutes
Drain phase 4 minutes
Total time 49 minutes (52 minutes with UFD-kit,
(optional))

Heat disinfection Program with CleanCart including WRO 300 H

Decalcification CleanCart-C
Cleaning CleanCart-A
Temperature 93 °C
Fill up phase 10 minutes (13 minutes with UFD-kit,
(optional))
Circulation phase 15 minutes
Low flow heat phase 20 minutes
Rinse/Drain phase 11 minutes
Total time 56 minutes (59 minutes with UFD-kit,
(optional))

Peracetic Acid Program

Concentration of 3.5 % peracetic acid


disinfectant
Concentration in machine 0.1 %; i.e. diluted 1 + 34
Consumption Approx. 65 ml
(Approx. 75 ml with UFD-kit, (optional))
Fill up and mixing phase 12 minutes
(17 minutes with UFD-kit, (optional))
Dwell time 10 minutes
Rinse/Drain phase 26 minutes
(46 minutes with UFD-kit, (optional))
Total time 48 minutes including 10 min dwell time
(73 minutes including 10 min dwell time
with UFD-kit, (optional))

HCEN9287 Revision 02.2010 Tech. data and specifications - AK 200 S 7:7


Program version 10.xx
Low concentration Peracetic Acid Program

Concentration of 0.35 % peracetic acid


disinfectant (0.35 % peracetic acid with UFD-kit,
(optional))
Concentration in machine 0.01 % ; i.e. diluted 1 + 34
(0.01 % ; i.e. diluted 1 + 34 with UFD-kit,
(optional))
Consumption approx. 65 ml
(approx. 75 ml with UFD-kit, (optional))
Fill up and mixing phase 12 minutes
(17 minutes with UFD-kit, (optional))
Dwell time 10 minutes
Rinse/Drain phase 19 minutes
(31 minutes with UFD-kit, (optional))
Total time 38 minutes including 10 min dwell time
(54 minutes including 10 min dwell time
with UFD-kit, (optional))

Hypochlorite Program

Concentration of 0.5% available chlorine (approximately


disinfectant 70% of sodium hypochlorite
concentration)
Concentration in machine 0.5% ; i.e. not diluted
Consumption Approx. 2000 ml
(Approx. 2500 ml with UFD-kit,
(optional))
Fill up and mixing phase 12 minutes
(25 minutes with UFD-kit, (optional))
Dwell time 10 minutes, Maximum 20 min
Rinse/Drain phase 26 minutes
(42 minutes with UFD-kit, (optional))
Total time 45 minutes including 10 min dwell time
(73 minutes including 10 min dwell time
with UFD-kit, (optional))

Formaldehyde Program

Concentration of 4% formaldehyde
disinfectant
Concentration in machine 4% ; i.e. not diluted
Consumption Approx. 2000 ml
(Approx. 2500 ml with UFD-kit,
(optional))
Fill up and mixing phase 12 minutes
(25 minutes with UFD-kit, (optional))
Dwell time 20 minutes
Rinse/Drain phase 45 minutes
(67 minutes with UFD-kit, (optional))
Total time 74 minutes including 20 min dwell time
(108 minutes including 20 min dwell
time with UFD-kit, (optional))

7:8 Tech. data and specifications - AK 200 S HCEN9287 Revision 02.2010


Program version 10.xx
Central Disinfection Program

Concentration of 0.1% peracetic acid or 0.5% available


disinfectant chlorine
Concentration in machine Not diluted
Consumption Approx. 3100 ml
(Approx. 3600 ml with UFD-kit,
(optional))
Dwell time Must be preset, maximum 20 min. for
hypochlorite
Total time 32 minutes (dwell time not included)
(63 minutes (dwell time not included)
with UFD-kit, (optional))

Other programs, total time

Rinse/Drain with CleanCart 31 min (32 min with UFD-kit, (optional))


Rinse/Drain 12 min (13 min with UFD-kit, (optional))
Drain 4 min

External Cleaning 70% ethanol or 60% Isopropanol

Water supply

Water Supply Flow Rate


Treatment 300 to 750 ml/min
Disinfection 0 to 1150 ml/min
Inlet Water Pressure
to regulator 120 to 800 kPa
to machine 85 to 120 kPa
Inlet Water Temperature
Treatment +5 to +30 °C
Disinfection +5 to +90 °C
Inlet Water Quality Inlet water quality must comply with
local regulations and if no such regulation
is available follow ISO 13959. Level
for conductivity shall not exceed 0.1
mS/cm. It is possible to use water with
higher conductivity if it consists mainly
of sodium salts. This may however affect
the accuracy of the fluid composition.
Inlet tube length Maximum 5 m or the specially designed
spiral PEX tubing

HCEN9287 Revision 02.2010 Tech. data and specifications - AK 200 S 7:9


Program version 10.xx
Drain

Drain (length of tube) Maximum 5 m


Drain capacity Minimum 1.0 l/min
Drain outlet Maximum 1.2 m above floor
If the optional air-gap on the machine is used the distance between the
air-gap and the drain must not be less than 0.3 m. For an electrically
adjustable stand in its lowest position this means that the drain must
not be higher than 580 mm. For a mechanically adjustable stand in its
lowest position the drain must not be higher than 550 mm.

Power supply

Mains Voltage 115; 230 V AC (±10%)


Frequency 50 to 60 Hz (±5 Hz)
Power Consumption Max. 2250 W at 230 V
Max. 1650 W at 115 V
Mains cable: 3 conductor cable, Length max. 3 m
rating 250 V 10 A, 13 -16A
Mains cable connector: Certified to IEC 60320/C19
Mains cable plug: Earthed plug, 250 V AC / 13 -16 A,
approved or Hospital grade, earthed plug,
125 V AC / 15 A, approved.
Earth Leakage Current max 500 μA
Patient Leakage Current max 100 μA
Fuses 2 x T 12 A
All leakage currents are specified without external equipment
connected to the machine.

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.

7:10 Tech. data and specifications - AK 200 S HCEN9287 Revision 02.2010


Program version 10.xx
External serial interface

External connector P 63 8 pin REDEL contact, black. RS-232


or RS-422 compatible connection. Opto
insulated fulfilling IEC 60601-1-1.
Attached cable length 2.5 m unshielded.
External equipment Serial port for connection to PC used for
logging and preset.

RS-232

Max input voltage ± 15 V DC


High level min output + 5 V DC
voltage
Low level max output - 5 V DC
voltage
Max output current ± 5 mA

RS-422

Max input voltage ± 7 V DC


Diff. input threshold ± 0.2 V DC
voltage
Diff. max. output voltage 5 V DC
Diff. min. output voltage 2 V DC
Short circuit output current 100 mA

External interface

External connector P 79 8 pin REDEL, yellow, configured as 1


make- and 2 change over- relay contacts.
Attached cable length 2.9 m unshielded.
External equipment Port for connection to central alarm
system and remote control of water
system.
Contact ratings
Max voltage 24 V AC or DC
Max current 100 mA AC or DC

External I/O Interface

External connector P 76 8 pin REDEL blue. Opto insulated


fulfilling IEC 60601-1-1. Attached cable
length 1,5 m unshielded.
External equipment Connection to Gambro UF Calibration
Unit. Service purpose only.

External interface

External connector P 64 8 pin RJ-45


External equipment Ethernet port for connection to network
intended for Exalis computer system,
download, preset and logging

HCEN9287 Revision 02.2010 Tech. data and specifications - AK 200 S 7:11


Program version 10.xx
Battery Back-up

Battery back-up of power 24 volt, 6.5 Ah


supply
Running time >15 minutes
Fuse T 15 A

7:12 Tech. data and specifications - AK 200 S HCEN9287 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

Blood Pressure Supervision


The alarm limits below can be preset. The value put in brackets and in
italics is the default value.

Venous Pressure

Operating range -700 to +750 mmHg


(±10% at -700 to -500 mmHg)
(±5 mmHg or 3% at -500 to +500 mmHg)
(±10% at +500 to +750 mmHg)
Alarm limit HIGH max +600 mmHg (+300 mmHg)
Alarm limit LOW min -50 mmHg (-50 mmHg)
When blood is detected the operator is
requested to centralize the alarm limits
and the low limit is by default set to +10
mmHg

Arterial Pressure

Operating range -700 to +750 mmHg


(±10% at -700 to -500 mmHg)
(±5 mmHg or 3% at -500 to +500 mmHg)
(±10% at +500 to +750 mmHg)
Alarm limit HIGH max +750 mmHg (+250 mmHg)
Alarm limit LOW min. -700 mmHg (-250 mmHg)

System Pressure

Operating range -700 to +750 mmHg


(±10% at -700 to -500 mmHg)
(±5 mmHg or 3% at -500 to +500 mmHg)
(±10% at +500 to +750 mmHg)
Alarm limit SN/DP HIGH +300 mmHg (+175 mmHg)
max
Alarm limit SN/DP LOW -200 mmHg (+10 mmHg)
min.
Alarm limit SP HIGH max +750 mmHg (+150 mmHg)
Alarm limit SP LOW min. -
Alarm limit Low-Volume +750 mmHg (+150 mmHg)
HDF HIGH max
Alarm limit Low-Volume -300 mmHg (+100 mmHg)
HDF LOW min

HCEN9287 Revision 02.2010 Tech. data and specifications - AK 200 S 7:13


Program version 10.xx
Air Detection

Sensitivity Bubbles larger than 1 μl will be trapped


by the drip chamber. An alarm will be
issued if the blood level falls below the
middle of the air detector.
Venous drip chamber size 22 mm
(diameter)

Heparin Administration

Heparinization volume ±0.3 ml of set value (±1 ml or 0.2 ml *


alarm limit heparinization time (h) or ±5%)
The accuracy is based on tests with 20 ml and 30 ml syringes

Dialysis fluid preparation

Temperature

Temperature alarm (fixed) 40 °C (±1 °C)

Conductivity

Alarm limits in Acetate ±5% of set value


mode
Alarm Limit in Bicarbonate ±5% of set value for A-step conductivity
mode, A-step
Alarm Limit in Bicarbonate ±5% of set value for B-step conductivity
mode, B-step
Alarm limits are temporarily extended to 10%. Maximum mean
deviation for a 5 hour treatment is 0.2 mS/cm.

Dialysis fluid preparation (BiCart Select mode only)

Dialysis Fluid Flow Rate 300 - 700 ml/min (±9 ml/min)


Dialysis Fluid Flow Rate ±5%
alarm limit
SelectBag Proportioning 1:400 ±12%, alarm given within 20
Ratio alarm limit minutes. For larger errors the alarm time
is shorter.
SelectBag Proportioning Ratio is defined
as the quotient SelectBag flow/dialysis
fluid flow

7:14 Tech. data and specifications - AK 200 S HCEN9287 Revision 02.2010


Program version 10.xx
Ultrafiltration

Dialysis fluid flow 300 - 700 ml/min


operating range
UF rate supervision -4.0 to +4.0 l/h (±2 ml/min) Accuracy ±5
ml/min verified at start-up.
UF rate supervision, max ±1-10 ml/min, (±5 ml/min)
allowed difference between
control and protective
system, can be preset
(Default)
Accumulated UF volume ±0.10 - 2.0 l (±0.80 l) or ±0.10 l/h *
alarm limit, can be preset passed treatment time (h)
(Default)
Treatment Time Control 0.05 to 9.59 hour.minute (±1 minute)
TMP supervision alarm -200 to +550 mmHg (±15 mmHg) For
AK 200 S dialysis machine, TMP 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 (Low volume HDF)

Infusion volume ±15% of calculated volume (±10%)


supervision alarm

Blood leak detection

Sensitivity ≥0.35 ml blood/min, haematocrit 32%


±2%, at 700 ml/min dialysis fluid flow
rate
Alarm response time 7 seconds
(diffusion mode)

HCEN9287 Revision 02.2010 Tech. data and specifications - AK 200 S 7:15


Program version 10.xx
Physical data

Depth Approx. 610 mm


Width Approx. 570 mm
Total Height Adjustable heights 1175 - 1340 mm
Five position stand 1152 - 1382 mm
Floor Area 573 x 753 mm
Weight Blood Monitor Approx. 17 kg
Weight Fluid Monitor Approx. 40 kg
Weight Stand Approx. 24 to 31 kg
Infusion Stand Height 1300 to 2150 mm
Max. load 10 kg
Transportation One man installation
Fitting into a normal Estate car

References
Assembly Drawing: K22100

7:16 Tech. data and specifications - AK 200 S HCEN9287 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)

HCEN9287 Revision 02.2010 Tech. data and specifications - AK 200 S 7:17


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.

Ambient Temperature range +18 to +35 °C


Relative Humidity range 15 to 85% RH
Air Pressure range (atm. 700 to 1060 hPa
pressure)
Maximum altitude ≈ 2000 m above see level

Transportation and storage


During transportation and storage the equipment has to be kept in
its original packing. If transportation or storage time is more than
15 weeks, the environmental data relating to the operation has to be
followed. The maximum ambient temperature for transportation and
storage in 96% Relative humidity is +40 °C.

Ambient Temperature range -20 to +70 °C


Relative Humidity range 10 to 96% RH
Air Pressure range (atm. 500 to 1060 hPa
pressure)

Electromagnetic environment
The AK 200 S dialysis machine is intended for use in the
electromagnetic environment specified below. The customer or the
user of the AK 200 S dialysis machine should assure that it is used
in such an environment.

Emissions test Compliance Electromagnetic environment – guidance


RF emissions Group 1 The AK 200 S dialysis machine uses RF energy
CISPR 11 only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause
any interference in nearby electronic equipment
RF emissions Class B The AK 200 S dialysis machine is suitable for use in
CISPR 11 all establishments, including domestic establishments
and those directly connected to the public low-voltage
power supply network that supplies buildings used
for domestic purposes
Harmonic emissions Class A (Not applicable
IEC 61000-3-2 for 115 V version)
Voltage fluctuations Complies (Not
/flicker emissions applicable for 115 V
IEC 61000-3-3 version)

7:18 Tech. data and specifications - AK 200 S HCEN9287 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 S dialysis machine requires
variations on (60 % dip in UT) (60 % dip in UT) continued operation during power mains
power supply for 5 cycles for 5 cycles interruptions, it is recommended that the
input lines. 70 % UT 70 % UT AK 200 S dialysis machine be powered
IEC 61000-4-11 (30 % dip in UT) (30 % dip in UT) from an uninterruptible power supply or
for 25 cycles for 25 cycles a battery.
<5 % UT <5 % UT
(>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

HCEN9287 Revision 02.2010 Tech. data and specifications - AK 200 S 7:19


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 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 S dialysis machine is used exceeds the applicable
RF compliance level above, the AK 200 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 S dialysis machine.
3 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m.

7:20 Tech. data and specifications - AK 200 S HCEN9287 Revision 02.2010


Program version 10.xx
Recommended separation distances between portable and mobile RF communications equipment
and the AK 200 S dialysis machine
The AK 200 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 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 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⎦

0,01 0.11 0.11 0.23


0,1 0.37 0.37 0.74

1 1.2 1.2 2.3


10 3.7 3.7 7.4

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

China RoHS declaration table according to SJ/T 11363–2006

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)

HCEN9287 Revision 02.2010 Tech. data and specifications - AK 200 S 7:21


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.

7:22 Tech. data and specifications - AK 200 S HCEN9287 Revision 02.2010


Program version 10.xx
Standards
The machine complies with the following standards:

IEC 60601-1 General requirements for safety, Class I, type B

IEC 60601-2-16 Particular requirements for safety of haemodialysis,


haemodiafiltration and haemofiltration equipment

IEC 60601-2-30 Particular requirements for the safety of automatic


cycling indirect blood pressure monitoring equipment

IEC 60601-1-2 Electromagnetic compatibility

EN 1060-1 Non-invasive sphygmomanometers Part 1: General


requirements

EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary


requirements for electromechanical blood pressure measuring systems

NFS 90-304 Medico-surgical equipment Hemodialysis equipment

HCEN9287 Revision 02.2010 Tech. data and specifications - AK 200 S 7:23


Program version 10.xx
This page is intentionally left blank

7:24 Tech. data and specifications - AK 200 S HCEN9287 Revision 02.2010


Program version 10.xx