UNISTERI HP - NP - en 2018-09 - V4.00

UNISTERI HP ®
Steam sterilizer
Instructions for use
UNISTERI HP_np_en 2018-09_V4.00

© BMT Medical Technology s.r.o.
The Instructions for use is protected by copyright law, the owner of the copyright being the
company BMT Medical Technology s.r.o. The Instructions for use is designed for personal use
only and it is not allowed to make it available to public in any way, as a whole or in parts. Breach
of the above stated regulations is considered to be a breach of the owner´s copyrights.
The Instructions for Use

- make an integral part of the product,
- must be kept for the whole service life of the product,
- must be handed over to any following holder or user of the product,
- must be completed with all and any notifications received from the manufacturer.
CONTENTS:
1 EXTENT OF VALIDITY....................................................................................................... 7
2 GENERALLY........................................................................................................................ 7
2.1 important instructions....................................................................................................................7
2.2 intended purpose..............................................................................................................................8
2.3 installation of the unit....................................................................................................................8
2.4 sterilization.......................................................................................................................................8
3 STEAM STERILIZATION.................................................................................................... 8
3.1 performance check..........................................................................................................................8
3.1.1 check by chemical process test.....................................................................................................8
3.1.2 check by chemical test of sterilization........................................................................................8
3.1.3 check by means of the bowie-dick test (bd-test).........................................................................8
3.1.4 check built in the unit......................................................................................................................8
3.1.5 check by means of biological indicators......................................................................................9
3.2 preparation of the sterilizer load................................................................................................9
3.2.1 textiles...............................................................................................................................................9
3.2.2 instruments.......................................................................................................................................9
3.2.3 rubber load........................................................................................................................................9
3.2.4 loads of special material.................................................................................................................9
3.2.5 liquids...............................................................................................................................................10
3.3 what may be sterilized....................................................................................................................10
4 DESCRIPTION OF THE UNIT ......................................................................................... 10

4.1 technical description.....................................................................................................................10
4.2 pressure device...............................................................................................................................10
4.2.1 assembly of the sterilizer pressure devices.............................................................................10
4.2.1.1 pressure chamber...........................................................................................................................10
4.2.1.2 steam generator.............................................................................................................................10
4.2.1.3 piping................................................................................................................................................. 11
4.2.1.4 safety and pressure equipment.................................................................................................... 11
4.3 doors................................................................................................................................................ 11
4.4 loading and unloading................................................................................................................... 11
4.5 control system plc......................................................................................................................... 11
4.6 data archiving, data export............................................................................................................ 11
4.7 simcon (ecosoft)............................................................................................................................. 11
4.8 steam supply.................................................................................................................................... 11
5 SPECIFICATIONS ............................................................................................................ 12
5.1 technical specifications.................................................................................................................12
5.2 indicating and operating elements.................................................................................................12
5.2.1 operation and material loading side............................................................................................12
5.2.2 the side of unloading the material .................................................................................................13
6 PROGRAMS - BASIC....................................................................................................... 13
6.1 heating .............................................................................................................................................13
6.2 universal .........................................................................................................................................13
6.3 universal containers .....................................................................................................................13
6.4 rubber...............................................................................................................................................13
6.5 bd - test ...........................................................................................................................................13
6.6 vacuum test vt.................................................................................................................................13
6.7 instruments quickly .......................................................................................................................14
6.8 other programs .............................................................................................................................14
6.9 programs use and validation.........................................................................................................14
7 ATTENDANCE OF THE DEVICE..................................................................................... 14
7.1 basic operations of the attendance............................................................................................14
7.1.1 touch display...................................................................................................................................14
7.2 everyday putting into operation .................................................................................................14
7.3 the device operation.......................................................................................................................15
7.3.1 inserting the material and program start..................................................................................15
7.3.2 unloading of the sterilized material ..........................................................................................16
7.4 switching off the apparatus.........................................................................................................16
7.5 program interruption....................................................................................................................17
7.6 information - display.......................................................................................................................17
7.6.1 actual operational information, monitoring of the input media.............................................17
7.6.2 course of the cycle - information...............................................................................................17
7.7 menu - users setting and services...............................................................................................18
7.7.1 display settings...............................................................................................................................19
7.7.2 date and time....................................................................................................................................19
7.7.3 print - setting..................................................................................................................................20
7.7.4 automatic start...............................................................................................................................20
7.7.5 change of the program parameters............................................................................................21
7.7.6 review of the inputs and outputs................................................................................................22
7.7.7 system versions..............................................................................................................................22
7.7.8 air detector.....................................................................................................................................22
7.7.9 chip card...........................................................................................................................................22
7.7.10 steam source - change of steam supply manner........................................................................24
7.7.11 supplementary commentary............................................................................................................24
7.7.12 protocol history, memory card....................................................................................................25
7.7.13 errors history................................................................................................................................25
7.7.14 automatic door opening.................................................................................................................26
7.7.15 automatic device switching - off..................................................................................................26
7.8 access rights (log on)...................................................................................................................26
7.8.1 open user.........................................................................................................................................26
7.8.2 individual access rights.................................................................................................................26
7.8.2.1 log on - change of the level.........................................................................................................26
7.8.2.2 administrator...................................................................................................................................27
7.8.2.2.1 setting the mode - individual access rights/open user............................................................27
7.8.2.2.2 password administration and access securing..........................................................................27
7.8.2.2.3 daily charge counter.....................................................................................................................29
7.8.2.2.4 choosing a third variable in the recording table.....................................................................29
7.9 audit trail.........................................................................................................................................29
8 OPERATION FAILURES................................................................................................... 29
8.1 technical safety devices................................................................................................................29
8.1.1 error messages, unloading of the charge in case of failure.................................................29
8.1.2 operational message......................................................................................................................30
8.2 electric energy outage.................................................................................................................30
8.3 outage of input media pressure (media monitoring)..................................................................30
8.4 blocking the operation in case of electrical energy deficiency............................................30
9 MAINTENANCE, CLEANING AND ATTENDANCE....................................................... 30

9.1 cleaning............................................................................................................................................30
9.2 printer attendance.........................................................................................................................30
9.2.1 servicing elements..........................................................................................................................31
9.2.2 indication of the printer state.....................................................................................................31
9.2.3 paper loading...................................................................................................................................31
9.3 sealing system of the sterilisation chamber.............................................................................32
9.3.1 fixed sealing....................................................................................................................................32
9.3.2 flexible / movable sealing..............................................................................................................32
9.4 time intervals for maintenance....................................................................................................32
9.5 interval of steam generator maintenance..................................................................................33
9.6 putting the device out of operation............................................................................................33
10 STEAM GENERATOR....................................................................................................... 33
10.1 steam generator operation...........................................................................................................34
11 ADDITIONAL MATERIAL AND CONSUMABLES......................................................... 34

11.1 sterilization chamber equipment..................................................................................................34
11.2 consumables....................................................................................................................................34
12 STERILIZER INSTALLATION ......................................................................................... 34

12.1 building site preparation and requirements...................................................................................34
12.2 requirements on service connections........................................................................................34
12.2.1 cooling water (for the vacuum pump) - kw.................................................................................35
12.2.2 feed water for the steam generator - dw..................................................................................35
12.2.3 drain - a.............................................................................................................................................35
12.2.4 electric power connection - e......................................................................................................35
12.2.5 pressure air - dl..............................................................................................................................35
12.2.6 steam for sterilization - fd...........................................................................................................35
12.2.7 softened water (for housing cooling) - ew................................................................................35
12.3 device assembly and putting into operation...............................................................................36
12.3.1 before the first device use...........................................................................................................36
12.4 transport instruction...................................................................................................................36
13 TRANSPORT AND STORAGE........................................................................................ 36

13.1 transport.........................................................................................................................................36
13.2 storage.............................................................................................................................................36
14 WAY OF LIQUIDATION..................................................................................................... 36
14.1 package.............................................................................................................................................36
14.2 unit....................................................................................................................................................37
15 REGULATIONS AND STANDARDS................................................................................ 37

16 WARRANTY AND SERVICE............................................................................................ 37
17 SUPPLEMENT................................................................................................................... 37
17.1 sterilization of solutions in open bottles with self-cooling.................................................37
17.1.1 simple sterilization of solutions.................................................................................................37
17.1.2 sterilizing of solutions with fo parameter................................................................................38
17.2 solution sterilization with the forced housing cooling.........................................................38
17.3 arnold steaming programmes.......................................................................................................38
17.4 large display (lcd) on the unloading side as well.....................................................................39
17.5 protocol of sterilization program..............................................................................................39
17.6 unicrash type programme..............................................................................................................40
17.7 error reporting..............................................................................................................................41
APPENDICES:
installation plans 336-1, 336-2, 559-1, 559-2, 636-1, 636-2
chart of tubular interconnection, unisteri hp 336: 11000151826, 11000151825, 11000162159,

Z476764, Z473671
Z476764
11000175805, Z476764
1 EXTENT OF VALIDITY • Pay attention to Chapter Operation of the unit

before the first use. Incorrect operation may cause
damage the unit.
This sterilizer user manual is valid for below mentioned • If the sterilizer is used in a not intended way, the
instrument models: protection provided by it can be impaired.
Name: UNISTERI® HP
Danger of electric shock
Models:
SPS 336-1 FD, ED,FDED
• As long as the unit is connected with the power network,
it is forbidden for the operating personell to take off or
SPS 336-2 FD, ED,FDED
SPS 636-1 FD, ED,FDED open the covers of the unit. These activities as well as
SPS 636-2 FD, ED,FDED the work on electrical parts may be performed only by an
SPS 559-1 FD, ED,FDED authorized person.
SPS 559-2 FD, ED,FDED Danger of burns and injury of the operator
Abbreviations and symbols used in the Instructions for use: • Liquids in closed bottles shall not be sterilized in the unit!
FD External source. • The doors of the sterilizer shall not be opened before the
ED Integrated source. end of the sterilization program.
FDED Either external or integrated source. • The sterilizer load is hot after sterilization, use gloves
when unloading it!
The below stated user manual does not have to be
consistent in details with your device model, it depends
on configuration of optional device components.
• After a long-term operation of the unit, the
upper part of the sterilizer’s door may be heated up to
Abbreviations and symbols used in the Instructions for use: a temperature over 70 °C; therefore burns of the operator
are possible. Please be extremely carefull!
! Danger of damage of the sterilizer
• You must not put or place any things, liquids etc on the
WARNING „Warning“ alerts the user to the possibility of personal sterilizer.
injury. • The sterilizer load is hot after sterilization, use gloves when
unloading it!
• Ventilation holes of the apparatus must not be covered.
• Requirements for the operating media must comply with
CAUTION „Caution“ alerts the user to the possibility of damage the properties mentioned in the documentation.
to the equipment. Sterilization of Solutions
In case of sterilization of water solutions, make sure, if the
NOTE „Note“ alerts the user to pertinent facts and conditions. adjusted final temperature for door opening and charge release
An authorized person is a person, who on basis of professional from the chamber corresponds to the altitude of the instrument.
education or theoretical and practical experience, has proved This temperature is displayed as parameter of the sterilization
sufficient knowledge regarding the problems of the steam cycle during its selection.
sterilizers documented by a written authorization to service 1. Attention! If the temperature of the opening does not
activities on the UNISTERI® HP unit, issued by the manufacturer. correspond to the below mentioned values, the program
for sterilisation of solutions must not be used till its correct
adjusting! Call the service.
The temperature of door opening in case of sterilisation of

liquids - correction to the altitude:
2 GENERALLY altitude above open closed bottles closed bottles-
sea level bottles - glass flexible
0 - 400 m 94 °C 79 °C 89 °C
401 - 800 m 92,5 °C 77 °C 87 °C
2.1 IMPORTANT INSTRUCTIONS 801 - 1200 m 91 °C 76 °C 86 °C
1201 - 1600 m 90 °C 75 °C 85 °C
! 1601 - 2000 m 88,5 °C 73 °C 83 °C
WARNING
2001 - 2400 m 87 °C 72 °C 82 °C
• The steam sterilizer UNISTERI® HP may be 2400 - 2800 m 86 °C 71 °C 81 °C
operated only by persons, who, on basis of their >2800 m 85 °C 70 °C 80 °C
training or knowledge and practical experience,
guarantee correct and proper operation. Workers
in charge of using the sterilizer shall be trained for
this activity and acquainted with the Instructions
for use. The keeper is held responsible for proper
training of the personnel in operating the sterilizer.
• The unit shall be used in accordance with the
Instructions for use to secure safety.
UNISTERI HP_np_cz 2018-09_V4.00 7/44

1.1 INTENDED PURPOSE 2.1 PERFORMANCE CHECK
!
WARNING he steam sterilizer UNISTERI® HP is a device
T 2.1.1 CHECK BY CHEMICAL
intended for use in the healthcare for moist heat
sterilization of unwrapped and wrapped medical
PROCESS TEST
devices including invasive devices according to the
EU directive 93/42/EEC, intended by their • Chemical process tests react by colour change already
manufacturer for sterilization by moist heat. on the presence of the sterilization media and serve for
distinguishing between goods prepared to sterilization and
goods already sterilized.
1.2 INSTALLATION OF THE UNIT • Every package unit must be provided with a chemical
process test indicator (it is also possible to use
a selfadhesive chemical process test indication tape, which
Assembly of the unit, its installation and first putting into
is stuck onto the package containing goods to sterilize).
operation may be performed only by an authorized person
• Use only wrapping material and indication tape destinated
in accordance with the instructions contained in Chapter 12
for steam sterilization.
„Installation of the unit“.
• This test cannot be used to prove that the sterilized load is
really sterile!
1.3 STERILIZATION
2.1.2 CHECK BY CHEMICAL TEST
Sterilization is a process which kills any viable microorganisms OF STERILIZATION
inclusive of their especially resistant spores.The sterilization
inactivates viruses irreversibly. Sterilization kills also organisms, • The chemical test of sterilization reacts by a colour
whose do not directly induce any disease of the patient, but
change in case the required values of some or all
might endanger him by weakening his organism.
sterilization cycle parameters have been reached.
• Use only chemical tests destinated for steam sterilization
and the test evaluating methodology (colour change
evaluation) recomended by the producer.
2 STEAM • This test cannot be used to prove that the sterilized load
is really sterile as well!
STERILIZATION
2.1.3 CHECK BY MEANS OF THE
During steam sterilization, saturated water steam condensates BOWIE-DICK TEST (BD-TEST)
on the material being sterilized, what causes its heating.
The condensate penetrates through the cellular shell of the
microorganism directly to the cell nucleus and destroys it due to • Perform the BD-test regularly every day before the
thermal energy transfer. From the said it is obvious that, inspite beginning of sterilization, after having run the first
of a relatively short sterilization exposure and low temperature, sterilization cycle with an empty chamber.
the sterilization effect of saturated steam is very high. Steam • The BD-test confirms the correct course of the sterilization
sterilization is suitable for sterilizing textiles made of cotton and program (venting, fractional course of vacuum, sterilization
heat resistant textile blends, metal goods with sufficient corrosion temperature during the exposure, steam quality...).
resistance and many articles made of rubber, plastics, ceramics • Perform the BD-test by strictly following the instructions
and glass. The used sterilization temperature is mostly 134 of the indicator manufacturer.
°C. Sensitive rubber articles, parts made of plastics, glass and • If you sterilize common porous materials in the device, it
sensitive mechanical appliances are sterilized at 121 °C. To suffices to perform the BD-test according to EN ISO 11140-4.
assess objects that are to be sterilized in saturated water vapour, • If you sterilize hollow objects, the BD-test must be
follow the instructions for use of such objects manufacturers. In performed using a process challenge device (PCD)
questionable cases, you should make sure at first whether such according to EN 867-5.
objects are resistant to increased temperature, moisture, and
temperature and pressure changes resulting from the sterilization
procedure. If this is not known in individual cases, you should 2.1.4 CHECK BUILT IN THE UNIT
make sure by a testing sterilization.
Steam sterilizers are provided with the possibility to print

a report on the course of the sterilization program and
CAUTION a record on the course of pressure and temperature. The
W
ater steam shall not be used to sterilize organic
mentioned prints serve as foundation for the documentation
materials such as wool, leather, optical fibres and
proving the quality of the sterilization process.The way
other thermally unstable articles. Act upon the data
of using these documents is determined by the person
from the manufacturer or importeur of the material
responsible for the operation of the unit.
to be sterilized.
8/44 UNISTERI HP_np_en 2018-09_V4.00

heavy accessible parts easier. Mutually connected instruments

2.1.5 CHECK BY MEANS OF or their parts create narrow gaps, which are quickly filled with
BIOLOGICAL INDICATORS condensate during steam sterilization. The thermal energy,
accumulated in the instrument, is transfered also to the
• A check by means of biological indicators of living spores condensate collected in the said gaps, which is being heated
provide reliable evidence about the sterilizer fitness for use. up to the sterilization temperature as well. But in comparison
• Follow the manufacturers’ instructions and proceed in with direct heating by condensing saturated water steam this
accordance with the locally applicable regulations. process requires much more time.
2.2 PREPARATION OF 2.2.3 RUBBER LOAD

THE STERILIZER LOAD
Rubber is principally sealing material. Sterility of rubber parts
When saturated water steam enters the chamber, can be achieved on condition that the individual surfaces
condensation of the steam on the loaded goods takes place. remain separated from each other. Rubber aprons or
Yet, a large quantity of air and other non-condensable gases kerchiefs can be sterilized with the aid of thicker textile pieces
restrain an ideal transfer of thermal energy from steam onto inserted between the surfaces of rubber material; here textiles
the goods being sterilized. Removal of mentioned gases and assist in penetration of steam. To avoid damage of rubber by
securing satisfactory drying of the sterilized load belong to heat, sterilization is performed at lower temperature of 121 °C
the most important tasks of the steam sterilization technology. and with longer sterilization exposure time. Having finished
The sterilized material plays an important role in this case. the sterilization cycle, it is necessary to remove the rubber
load from the hot sterilization chamber as soon as possible.
Decisive parameters co-acting during sterilization:
• Quantity of heat supplied into the sterilizer load, i.e. the
temperature rise, weight and specific heat of the loaded 2.2.4 LOADS OF SPECIAL MATERIAL
material.
• Flow resistance, i.e. the factor influencing the speed
of air removal from the sterilizer load. A large quantity of condensate is created in thick-wall
• Uneven distribution of moisture due to condensate hoses. In case that the hoses are not laying horizontally,
dropping down during sterilization of instruments. the condensate concentrates in the lowest part of the hose.
Venting of deep cavities in catheters and in some instruments
NOTE When choosing the proper sterilization programme, is very difficult. a lot of residual air and condensate remain
adjusting and loading some material into the sterilization between flat parts of the instrument if there is a narrow gap
chamber, follow preferentially the instructions for use of the between them during sterilization. Such parts and hollow
manufacturer of such sterilizable material. bodies shall be also sterilized with fractional vacuum pre-
cycles with a sufficiently long sterilization exposure.
In case of trays loaded with goods and stacked one over
the other in the chamber it is necessary to secure suitable
2.2.1 TEXTILES removal of residual air, and thus making penetration of steam
easier, by insertion of sufficiently thick textile layers between
Folded textiles consume a large quantity of thermal energy the individual trays. Due to condensation of steam it would be
when being heated. Due to their large airflow resistance very difficult to separate, after sterilization, the trays stacked
folded textiles hold back air. Therefore textile loads with without using textile pads. Objects of dish or spoon shape
layers oriented in the sterilization chamber horizontally should should be turned with their mouths down.
be sterilized only at fractional course of vacuum. In case of Vessels with covers or other containers without open outlets
vertically arranged textile layers, the air removal from the can get deformed due to the alternation of steam pressure
space between the individual textile pieces is substantially and vacuum, or they can be non-sterile. Such objects are not
simpler. Textile pieces should not be compressed each suitable for steam sterilization.
other, also their location in the sterilization container Empty bottles are recommended to be sterilized with their
should be loose. The specific mass of standardly wrapped bottoms up, using the program with 121 °C. In the opposite
textiles is approximately 0.11 kg/dm3, what corresponds to case, the condensate accumulated during sterilization at the
approximately 5-6 kg/STM (STM ═ sterilization module). bottom of an empty bottle cools down very quickly during the
drying in vacuum. Consequently a heavy heat stress arises in
the glass, which could cause cracking of the bottle. Never put
2.2.2 INSTRUMENTS the bottles by their whole bottom’s surface on a metal support.
Silicone prostheses, as well as some endoscopes may be
sterilized in saturated water steam. Follow the instructions of
When heating heavy instruments a large quantity of
their producer.
condensate arises on their surface, which is droping down and
humidifies the other goods being located in the lower part of Hollow bodies and bodies with untight closures can be
the sterilization chamber. Therefore it is advantageous to locate sterilized by steam only in case that the interior space of this
heavy instruments on lower trays. The quantity of condensate body is filled with sufficient quantity of water. The heated wall
is substantially dependent on the character and weight of the in contact with water causes evaporation in the interior space
instruments itself. Articulated instruments should have been of the body, but it is necessary to consider the time needed
opened or disassembled before loading them into the chamber, for equalization of the temperatures.
what makes the removal of residual air and condensate from

• easy and comfortable operation,

2.2.5 LIQUIDS • modest maintenance,
• external covering made of stainless steel,
The program for sterilization of liquids in open bottles is • modern design,
delivered as supplementary equipment (addition). This • wide offer of the additional equipment (additive).
program has a specific course and the temperature of liquid
being sterilized is scanned by a movable sensor.
3.2 PRESSURE DEVICE
2.3 WHAT MAY BE STERILIZED The pressure devices of the stabiliser are designed, produced
and tested according to the procedures given by the EU
Directive No. 2014/68/EU. Pressure devices of a sterilizer,
! are made as an assembly that is defined by piping schemes.
Safety of operation of this assembly is connected with the
WARNING Inside the apparatuses UNISTERI® HP it is possible working safety of the complete sterilizer and it is described
to sterilize only such material, which is permitted for in the appropriate chapter of these instructions. Procedures
a steam sterilization by the manufacturer: for maintenance, cleaning, attendance of pressure parts,
• instruments, inclusive recommended intervals are also included in these
• textile, instructions. Inspection and periodical checks of the sterilizer
• objects made form rubber, pressure devices at the user’s place are regulated by national
• objects made form plastics (withstanding the sterilization regulations for operation of pressure devices.
temperature),
• water solutions in opened bottles (only by corresponding
programme for solution sterilisation!).
• qater solutions in closed bottles (only by a programmewith 3.2.1 ASSEMBLY OF THE STERILIZER
forced cooling for solution sterilization and after consulting PRESSURE DEVICES
the sterilizer manufacturer!).
• pressure chamber of the sterilizer (according to the
required volume and number of doors);
• electric steam generator;
• piping;
3 DESCRIPTION OF THE • safety and pressure equipment.
UNIT
3.2.1.1 PRESSURE CHAMBER
Technical data of pressure equipment are contained in the

3.1 TECHNICAL DESCRIPTION documentation supplied together with the sterilizer.
Information for continuous checking of the pressure vessel

The UNISTERI® HP unit is a modern steam sterilizer with during operation:
1-2 STM of usable volume.
Sterilizer type Permitted number of
Technical features: sterilization cycles
• single-door (single sided) or double-door (double sided) type, UNI 336* 30 000
• built-in steam generator, UNI 559* 31 000
• fractional vacuum by means of a heavy-duty water-ring UNI 636* 34 500
pump,
*Version: single-door (1), double-door (2), right (R), left (L).
• sterilization chamber with a heated jacket made of
stainless steeel,
• material of the chamber AISI 316L,
• automatic microprocessor control (two microprocessors
3.2.1.2 STEAM GENERATOR
master and slave),
• check of the individual sterilization phases during the General description
whole cycle, The electric steam generator serves for production of pure
• easy control of 8 programs by means of multi-function steam from completely demineralized water. It is an additional
pushbuttons, device of the sterilizer. The produced steam can contain
• LCD display showing commands for the operator, phases neither hydrazin(N2H4) nor other volatile, corrective chemicals
nor corrosion inhibitors. The steam generator can be supplied
of the sterilization cycle, error messages, etc.,
only with properly treated, completely demineralized water.
• intuitive control and communication,
We recommend to use the treatment method of reverse
• control of steam pressure by means of sensors
osmosis. The generator is equipped with the device for
independent on the atmospheric pressure,
thermic degasification of feedwater of the generator.
• doubled pressure and temperature sensors for an
independent check of the sterilization process, Equipment
• easy installation, • Digital pressure gauge displaying the generator pressure;
Pressure sensor for steam overpressure regulation;

• Operating level indicator in the generator for switching

the feeding pump on and heating elements protection if
3.5 CONTROL SYSTEM PLC
there is not enough of supply water;
• Safety level indicator for protection of the steam An important part of the unit is the double-processor
generator and heating elements it there is not enough of automatics (master-slave) which performs the service of
supply water (electrical steam generator); controlling, regulating and recording the automatic course of
• Safety thermostat for the generator and heating elements operation, and evaluates all operation and fault conditions. In
protection; case of an interruption of the automatic course of operation
• Level indicator in the reserve tank for supply water level due to external influences (outage of electric energy or of
regulation; some of the media) the automatics is able, after restoration
• Safety valve. of the normal operating conditions, either to continue the
operation or to return the unit safely into the initial status.
Main technical parameters
Technical data of pressure equipment are contained in the
documentation supplied together with the sterilizer. 3.6 DATA ARCHIVING, DATA EXPORT
The device is equipped with a 9-pin Canon connector (RS232) to

3.2.1.3 PIPING which the print data are sent. a PC can be connected there. BMT
supplies special PrinterArchiv software for PC data collection.
The software allows well-arranged collection of data sent by the
Individual pressure devices of the assembly are interconnected
sterilizer to the printer. The data are saved to the PC hard disk.
with piping according to the schemes. The maximal inside
The sterilizer can also be equipped with an integrated printer (an
diameter of the used piping is DN 32 and the product PS*DN is
accessory).
lower than 1000 bar.
NOTE If the SimCon function is switched on in the
sterilizer, the external data archiving cannot be used as
3.2.1.4 SAFETY AND PRESSURE SimCon uses the same connector and has higher priority.
EQUIPMENT
The safety and pressure equipment is described in the 3.7 SIMCON (ECOSOFT)
pipeline connection diagrams and consists mainly of:
• Safety valve V2; UNISTERI® HP can use an optional SimCon (Simple Connect)
• Level switch B90 (HW) – regulation of the operating function. It allows the sterilizer integration in the Hospital24
water level in the generator; network by means of SimCon Netbox. SimCon NetBox is
• Level switch B91 (NW) – emergency heating switch-off if a device which is connected to the sterilizer by means of a serial
the water level in the generator is low; RS232 line. The other device terminal is connected to the local
• PE3 – pressure sensor JUMO – regulation of pressure in computer network. The network server saves all sterilization
the generator; cycle records and generates the sterilization protocols. The
• Thermal fuse TE1 – protection of the heating elements procedure is uniform for all different types of devices integrated
in the generator (e.g. in case of an emergency operation in the network. The SimCon function can be switched off from
without water); the service menu and its serial channel is then free for print data
• PE1.1, 1.2, 2 – pressure sensors JUMO – regulation of sending and archiving e.g. by means of PrinterArchiv software.
pressure in the sterilization chamber jacket and chamber;
• PT1.1, 1.2 – temperature sensors PT100, JUMO – NOTE If SimCon is switched on but disabled for any
sterilization chamber temperature checking. reason (e.g. a disconnected cable etc.), neither the printer
will print nor the data will be sent to an external device. If
this happens, the cause must be corrected and the sterilizer
3.3 DOORS must then be switched off and on.
Depending on the model, the sterilization chamber is

equipped either with one or two hinged doors. The door 3.8 STEAM SUPPLY
closing is manual with an automatic locking mechanism and
door sealing. There are the following variants for steam supply
(accessories):
FD External source,
3.4 LOADING AND UNLOADING ED Integrated source,
FDED Either external or integrated source.
Sterilizers can be, according to the order, equipped with a shelf

system or transport wagons (TW) and loading wagons (BW).

4 SPECIFICATIONS 4.2 INDICATING AND OPERATING

ELEMENTS
4.1 TECHNICAL SPECIFICATIONS

4.2.1 OPERATION AND MATERIAL
Volume of the sterilizer chamber in sterilization modules: LOADING SIDE
336:1
559:1
636:2
Dimensions of the sterilization chamber:

Variant Internal dimensions of Category Volume
the chamber according to [liters]
(height × width × depth) directive No.
[mm] 2014/68/EU Touch
display
UNI 336* 320 × 320 × 625 II 73
UNI 559* 509 × 509 × 990 II 254
UNI 636* 670 × 350 × 700 II 160
*Version: single-door (1), double-door (2), right (R), left (L).
Chamber
Technical data of Used Electrical Steam Generators: doorgrab
handle
Designation Power Volume Category
input [liters] according to
directive No. Service
kW
2014/68/EU door
NAD 336-7,5* 7,5 7,2 I
NAD 559-22,5* 22,5 25 II
NAD 636-15* 15 9,9 I
*Version: right (R), left (L).
Operating voltage: ............................3 × 230/400 V ±10 %
Mains frequency: ..............................50/60 Hz ± 5%
Overvoltage installation category: ....2
Current type: .....................................3PE
Steam pressure: ...................................... 2,5 bar ± 10 %
overpressure
Medium acoustic power: ...................<65 dB(A)
Environmental conditions:
environmental temperature: .............+ 5 up to + 40 °C
maximum relative humidity: ..............85 % at 31 °C
maximal altitude: ..............................3 000 m
Other specifications and data for installation and connection of
the unit see the „Installation plan BMT“. Some parameters may
differ according to the model and destination.

4.2.2 THE SIDE OF UNLOADING 5.3 UNIVERSAL CONTAINERS

THE MATERIAL
Sterilization program with parameters:
- Standard de-aeration;
Failure Display - 134 °C/7 min;
- Intense drying.
5.4 RUBBER

- 121 °C/20 min;
- Drying standard.
5.5 BD - TEST
The Bowie-Dick test is a test of steam penetration. It is

performed at 134 °C/3,5 min checking temperature and time.
The BD - test is used to ascertain whether the deaeration and
the subsequent steaming of porous material is sufficient and
whether the required temperature is obtained in the material
Phase of the To open Stop Time to the Phase of the during the whole period of sterilization exposure. The BD-test
sterilisation the door cycle end sterilisation should be performed in a preheated state (e.g. after having
cycle cycle run a sterilization cycle with the chamber empty). Follow
the instructions in chapter 3.1.3. Follow the manufacturer’s
instructions for the test evaluation.
5 PROGRAMS - BASIC 5.6 VACUUM TEST VT
Expulsion of the air from the sterilization chamber, first of

all from the goods to be sterilized, is the basic precondition
5.1 HEATING of a successful sterilization, securing that all germs will be
killed. In the opposite case, the remaining air would create
„air nests“ inside the porous material and with regard to poor
The program for sterilizer heating to the operating temperature. thermal conductivity of the air it would not be possible to
reach the necessary sterilization temperature in said nests.
! a minimum air leakage to the sterilizer during the period of
vacuum is required. Therefore the program control is provided
WARNING The program must not be used for sterilization! with a vacuum test to prove tightness of the sterilizer chamber
We recommend to use the program in following cases: under vacuum. The vacuum test shall be run with the sterilizer
- before performing the BD test chamber empty and is performed as follows: First, the chamber
- in the end of a business day in case of the last operation is being evacuated, a 5 min. equalizing phase follows, and then
one to be the de-contamination program, program the actual test, lasting 10 minutes, is started.
of solutions sterilisation or some other program not After finishing VT program on the screen there appears the
including vacuum drying. particular message containing the test result. VT is performed
in cold operation status. In case of an inconvenient result, the
VT must be repeated and if the tightness of the device does
5.2 UNIVERSAL not conform even for the second time then it is necessary to
shut down the sterilizer. Before next use it is necessary to have
the apparatus inspected by a service technician and in case of
Sterilization program with parameters: need to repair it. Then the VTmust be performed repeatedly.
- 134 °C/7 min;
- Standard drying. !
WARNING The residual moisture in the chamber may be the
cause of an unsuccessful vacuum test.

5.7 INSTRUMENTS QUICKLY 6 ATTENDANCE OF THE

DEVICE
- Shortened de-aeration;
- 134 °C/4 min;
- Shortened drying.
6.1 BASIC OPERATIONS
! OF THE ATTENDANCE
WARNING This program may be used only in cases, where
the operational measures ensure that the sterilized
unwrapped instruments will be used immediately
without storage or transportation. In other cases, 6.1.1 TOUCH DISPLAY
where a protection of the sterilized goods by
suitable wrapping is needed, this program shall not For communication and controlling of the sterilizer there
be used. serves the touch display, on which there are displayed the
The program Tools Fast has a shortened de- necessary information. The required function is selected
aeration and that is why it is not allowed to be used with a light touch of a finger (for ca. 1 sec.) to a box being
for porous objects or objects containing so called displayed as a press-button. Controlling and communication
long cavities! with the apparatus is intuitive.
NOTE Individual programme versions may differ according to
the country of destination. 6.2 EVERYDAY PUTTING
INTO OPERATION
5.8 OTHER PROGRAMS • Perform the specified maintenance.
• Indication on the display: (readiness display)
At the request (additive) the sterilizer can be equipped
with a series of other sterilizing and disinfecting programs.
(Programs for Solutions, Endoscopes, Aloplast, Prions,
Laparoscopes, Agars, Disinfecting programs, etc.) The
sterilizer can directly dispose of up to 20 programs. Another
possibility is using the chip cards for further extension,
saving, installation and modification of programs.
5.9 PROGRAMS USE

AND VALIDATION
The sterilizer user is responsible for correct choice of sterilization

programs depending on the kind and quantity of the sterilized
objects/medical devices. According to EU Directive no. 93/42/
EEC, the manufacturer of a medical device for repeated use is
obliged to provide the device with information relating suitable
cleansing, disinfection and sterilization procedures and a limited
number of repeated uses, if any. Repeated sterilization of
a specific load (its kind, quantity, packing and storing in the
sterilizer chamber) to a required sterility level by a specific
sterilizer program can only be verified by the sterilization
procedure validation according to EN ISO 17665-1.

• Switching on the apparatus. Press a touch display

(wherever on the surface of the initial screen) On the
display there is displayed the basic screen.
• The other possibility of the program selection is pushing

the button PROGRAMS.
• Subsequently push the required program P1, P2, ….Px
• Perform V-test. Record the result of the vacuum test into of the following basic display of programs.
the apparatus´ log.
• Perform a no-load sterilization (Heating programme).
• Perform BD-test (recommended).
6.3 THE DEVICE OPERATION
6.3.1 INSERTING THE MATERIAL AND

PROGRAM START
• Open the door from the side of inserting the material

push the button OPEN.
• Insert the material for sterilization.
• Press the door slightly to close it. The chamber door will
be closed and locked automatically.
NOTE For possible finding other pages of the program
selection, use the button:
• Push the button Start.

The programme runs automatically to the end. There is actual
information on the display in the course of the sterilisation cycle.
Selection of the program

• Select the required program with push-buttons of direct
selection P1, P2, ….Px on the bottom bar of the display
(the push-buttons of fast program selection).

• Completing of the sterilization cycle is indicated In case of double door apparatuses:

acoustically. The indication on the display:
• Press the button the door on the unloading side will
open.
• Unload the sterilized material.

• Take off the typeout from the printer (additive).
The door on the side of inserting the material remains closed so
long, as long as the door on the side of unloading the material is
opened. After opening the door on the inserting side the door on
• Push the button OK. the unloading side is already blocked. After a successful course
of the programmes of BD-test and V-test it is possible to open
NOTE
only the door on the side of the inserting the material.
Button enables to switch off the audible NOTE
warning. For the purpose of lowering the thermal loss and
preventing the pollution of the internal space of the sterilizing
chamber, on condition when the apparatus is not being used,
we recommend to leave the door closed.
6.3.2 UNLOADING OF THE STERILIZED
MATERIAL
6.4 SWITCHING OFF
THE APPARATUS
In case of single door apparatuses:
• Push the door´s button OPEN, you open the door in this
procedure.
• Push the apparatus switch on the display:
Indication on the display:
• Unload the sterilized material.
The apparatus is switched off into the standby state.

In case of two-door apparatuses it is possible to open the

6.5 PROGRAM INTERRUPTION doors only in the side where the material in loaded.
If for whatever reason it is necessary to interrupt the

program, it is possible to carry out it whenever in the course !
of the whole sterilization cycle. WARNING In this case the material, which should have been
sterilized, cannot be considered as to be sterile one.
• Push the button:
Indication on the display:
6.6 INFORMATION - DISPLAY
6.6.1 ACTUAL OPERATIONAL

INFORMATION, MONITORING OF
THE INPUT MEDIA
• For the display of the actual operational information push

the button INFORMATION.
On the information screen there are the basic information
about the apparatus, tests and the actual values of pressure
and temperature. The apparatuses, which are equipped with
the function media monitoring (additive), display as well
as the actual values of pressure of the input media on the
information screen. The pressures are displayed in absolute
values (absolute pressure). The pressures of the media
are continuously monitored by the automatic mode of the
The apparatus remains stopped! apparatus and in case of insufficient input pressure of some
In such a case that you want the program to be continued: medium there is displayed the appropriate operation report.
• Push the button Don't Interrupt. Report on low pressure of the medium is displayed also in
the protocol of the apparatus printer.
In such a case that you want to terminate the program and
to open the door of the sterilization chamber:
• Push the button Confirm.
For the termination of this screen, push the button for return:
• Enter the name (only if it is requested in given mode of

operation). 6.6.2 COURSE OF THE CYCLE -
• Enter the password and confirm by button Enter:
NOTE
↵ INFORMATION
The password is pre-set to empty line by the
manufacturer, in this case, a confirmation by the “Enter” In the course of the cycle it is possible to switch the screen
button is sufficient. The administrator is allowed to change into other types of information displays in the bottom menu
the names and passwords. bar.For the change of display, push the button of the
required display:
Program is automatically terminated in a controlled mode.
It will be performed a short drying, compensation of the
pressure in the chamber to the atmospheric value and the
door will be unsealed. After that it is possible to open the
door and to unload the sterilized material from the chamber.

• Basic screen of the running sterilization cycle: • Digital record of pressure and temperature:
• Simplified display of the running program with the optical

cycle indicator:
6.7 MENU - USERS SETTING AND
SERVICES
Menu makes possible for the attendance a detailed setting

of the apparatus.
NOTE Apart from the services, which are accessible for

the attendance, the sterilizers are equipped with a series of
services determined for the service. These servicing
services are not accessible for the attendance.
• For the access to the services, push the button MENU.
• Graphic record of pressure and temperature:

On this screen there are emphasized all the services, which are
accessible to the attendance. For the selection of the required
6.7.2 DATE AND TIME
service, push the button of the appropriate selection:
• Push the button MENU/Date And Time.
In order to finish, push the button for return:

• Insert the name (only if required in the given mode).
↵
• Insert the password and confirm it by pressing Enter:
6.7.1 DISPLAY SETTINGS NOTE The password is pre-set to empty line by the
manufacturer, in this case, a confirmation by the “Enter”
• Push the button MENU/Display Settings. button is sufficient. The administrator is allowed to change
On the screen it is possible to select subsequently by the names and passwords.
pushing the appropriate button: • By pushing you activate the line of time and by means of
the keyboard you set the actual time.
• By pushing you activate the line of time and by means of
the keyboard you set the actual date.
• Language - s election of the language of the

display communication.
• Palette - selection of colour environment
on the displayi. • In order to finish, push the button for return:
• Options
Silent Mode - switching off the audible
warning.
Impressive Look - s election of bigger type size on
the basic display.

6.7.3 PRINT - SETTING
• Push the button MENU/Print.

• Select the required functions from the screen.
(The data will be printed according to the actually set

configuration.)
Output Direction: • User Color Profile - this function permits the printing of
• Printer - activation of the built in printer(additive). values of custom adjustment of the colour environment.
• PrinterArchiv - activation of the output to PrinterArchiv For the termination of this screen, push the button for return:
(archiving of the output data from the sterilizer in the
computer).
Pressures And Temperatures Record NOTE In case of a failure the printer lists the appropriate
• Graphic - activation of the graphic form (line) record failure reporting. In case of a long time archiving it is
of pressures and temperatures. After pushing the button necessary to keep the record from the printer in dry and
Print period it is possible to set the required frequency of cold environment without a direct light.
the appropriate points of the graphic record (interval).
• Digital - activation of the digital form of record of
pressures and temperatures. After pushing the button 6.7.4 AUTOMATIC START
Print period it is possible to set the required interval of
listing of the values of the digital record.
This service makes possible to program the automatic start
• None - record of pressures and temperatures is switched off.
of the apparatus.
Immediate Print: It enables the selection of a vacuum test and another
• Last Protocol - this function makes possible the sterilization program.
additional printing of the last protocol from the memory • Push the button MENU/Automatic Start.
of the apparatus. (printing the data will be performed
according to the actually set configuration)
• Protocol History - this function enables choosing the
required record (last 10 records) from the history and
its printing, or displaying the record of pressure and
temperature sensors in a graphical or numerical form on
the display.
For setting of the required Date And Time of the automatic

start, push the button Date And Time and set the required
values.
By pushing the button Tomorrow Again, it is set the time of
the last (applied) automatic start and tomorrow´s date. (For
example, this button is suitable for everyday repetition of the
automatic start at the same time.)

For selection of the first program (A), push the button

Program A.
From the following screen, please, select in case of need
the required VT test. By pushing the button None Program
the VT test is omitted.
If necessary, the automatic start could be deactivated

anytime by pressing the button: Deactivate Auto. Start.
For selection of the second program (B), push the button 6.7.5 CHANGE OF THE PROGRAM
Program B. From the following screen, please, select in PARAMETERS
case of need the required sterilization program. By pushing
the button None Program the program B is omitted.
This service makes possible to adapt in the user´s mode the
selected parameters of the sterilization cycle (additive).
!
WARNING The editing may be performed only by a qualified
person! By this procedure it is possible to
significantly influence the sterilization efficiency of
the edited program! The manufacturer does not
responsible for the parameters of the program
edited in such a way!
• Push the button MENU/Program Parameter Change.
For termination push the button for return:
By pressing the button “Activate Auto. Start”, the automatic

sterilization start is activated and the device is started at
given time automatically.

operation).
↵

NOTE • For storage of the parameter change, push the button

Save. By repeating of the mentioned procedure it is
possible to change other parameters and other programs.
button is sufficient. The administrator is allowed to change
the names and passwords. • Finally in the output from the service, push the button Enter.
• Overall setting of the edited parameters, please,
subsequently record into the memory by pushing the
button Save.
NOTE
• In case of need, all preset values of the programme can

be restored by means of the D button.
• The permitted range and preset (original) value of
a parameter is shown in the brackets at each individual
parameter.
• An adjusted parameter is provided with a red mark.
Number of evacuations 4(0, 13) (3).
• If the programme data are modified, the printer record will

show it as well.
• Access to a complete set of sterilization programme
parameters and possibility to edit them from the device
screen is allowed to the service only!
• Select the required programme.
6.7.6 REVIEW OF THE INPUTS AND

OUTPUTS
This service makes possible to display the actual values

of the inputs and outputs.
6.7.7 SYSTEM VERSIONS
This service makes possible to display the actual version

of the software and hardware of the apparatus.
6.7.8 AIR DETECTOR
• Use arrows to select the required parameter. The air detector (aditivum) operates automatically and in case
of possible exceeding of threshold of the noncondensed gases
• Use the +/- button to change the parameter: +/- in the sterilizer chamber, it announces the appropriate error
• Insert the new value of the given parameter and confirm message, which interrupts the sterilization cycle. In case of
it by pressing the Enter button. (The permitted range of instruments with the activated Air detector, the corresponding
the adjusted parameter is shown in the brackets.) information is printed on the printer too. The eventual adjusting
of the Air detector is described in the service manual.
6.7.9 CHIP CARD
This service (optional equipment) allows: Programmes

copying from the chip card to the device and conversely;
Programmes deleting;
Individual programmes transferring within the device.
• Insert the chip card in the reader on the front panel of the
device (printed side up).
• Press the buttons MENU/Chip Card.

• Enter the name (only if it is requested in given mode • Press button for copying.
of operation).
NOTE
↵
button is sufficient. The administrator is allowed to change
the names and passwords. The administrator can change
the password.
• Press the Confirm button to confirm the copying.
Programmes copying from the device to the chip card:

• Press the buttons of the programmes you want to copy
and then the buttons relating to the chip card to define
where the programme is to be copied.
NOTE Select equal number of programmes on both sides

for copying!
The selected programmes will be copied to the chip card.
NOTE Programmes copying from the chip card to the

device can be performed similarly.

Programmes deleting:
• Press the buttons of the programmes you want to delete
6.7.10 STEAM SOURCE - CHANGE OF
(on one side only). STEAM SUPPLY MANNER
(only for devices with the electrical steam generator and

aditivum for combined supply - FDED). This service makes it
possible to change the actual steam source for the sterilizer.
This service allows you to change the current steam source
for the sterilizer.
Option of the supply manner (change) is made as follows:
• Press the buttons MENU/Steam Source.
• Press the Delete button and then the Confirm button.
Supply from the central (external) steam source

• Press the button External Steam Source.
To finish, press the button:
• Close the manual valve of the steam supply from the el.
generator and open the valve for the steam supply from
an external source.
Supply from the own el. generator
Check, if the valve for demi-water supply is open - DW into
the device.
Individual programmes transferring within the device: • After water is topped up, the generator starts working
• Press the button of the appropriate programme you want automatically. The electrical steam generator is ready
to transfer. to operate as soon as the working pressure is reached
• Press the button of a free (Not Defined) programme (approx. 340 kPa).
where the given programme is to be transferred. • Close the external valve of the steam supply from the
• Press the Transfer button and then the Confirm button. central source, open the manual valve of the steam
To terminate the service, press the Return button: supply from the own (integrated) generator.
NOTE
• Individual programmes can only be transferred to free 6.7.11 SUPPLEMENTARY

programme positions and on the device panel only. COMMENTARY
• The Read button allows programmes re-reading from the
chip card and their displaying on the screen. The device allows to the operating personnel to write
• Up to 20 programmes can be stored on the chip card. a supplementary commentary to individual programmes,
• Chip card UNISTERI® HP, ordering no. BMT: 010445887 respective to the charge. The commentary may be on up to
(the UNISTERI® HP card is not compatible with the chip three independent lines (eg.: product name, charge number,
cards of older BMT devices). batch number etc.). The commentary appears also on the
printer output.

How to write the commentary: a graphical or numeric way. The button Display Period [s] n
• Press the MENU/Additional Comment. allows selection of the sampling period for graphic and table
expression of temperature and pressure parameters of cycles.
• To end the mode, press the Return button:
SD memory card
The memory card is used for large-extent history saving
of sterilization protocols. The memory card allows also the
Audit Trail recording.
• Press Menu/Protocol History /Memory Card button:
• Press the button of the correspondent sterilisation programme.

• Press the button of the row (1,2,3) and write (edit) the
commentary.
• Repeat the procedure fr individual programmes and rows.
• Press the button for return to finish:
The check button On/Off activates the function „Additional

Comment“:
The memory card can be then used for any individual saved
protocol displaying.
NOTE The commentaries to individual programmes are
stored in the device memory also if the activation is off. The
6.7.13 ERRORS HISTORY
commentary is displayed together with the parameters during
the programmes selection and is printed by the printer.
Press the buttons of the service MENU/Error History.
6.7.12 PROTOCOL HISTORY, MEMORY

CARD
• Press the buttons of the service MENU/Protocol History.
This function allows showing the error messages history

(last 20).
• To end the mode, press the Return button:
This function allows the selection of the required record (last

10 records) from the history and to show on the display the
record of the pressure and temperature sensors either in

6.7.14 AUTOMATIC DOOR OPENING 6.8 ACCESS RIGHTS (LOG ON)
Setting the function of automatic sterilizer door opening The device could be used in two modes of operation:
after the end of the sterilization cycle. • Open User;
The administrator can activate this function for selected
programmes. • individual access rights.
The device is pre-set for free use (this status is displayed on
• Press MENU/Automatic Door Opening. the display by the inscription “Open User“).
6.8.1 OPEN USER
The device behaves as free equipment in this mode of

operation. The user must not log on in the mode “Open User”.
NOTE The administrator has only the possibility to set

some restriction for free use.
6.8.2 INDIVIDUAL ACCESS RIGHTS
The device enables to set access rights for the user on the
levels:
• user (device operation);
Activate the automatic door opening for selected programmes. • administrator (working place head).
• Then press the button for return:
6.8.2.1 LOG ON - CHANGE OF THE LEVEL

6.7.15 AUTOMATIC DEVICE SWITCHING
- OFF Log on, change of the access rights level (e.g. to the
administrator level):
• Press the button with the key symbol on the upper display
The function allows the device operator to choose the period of bar:
time after which the device (if not in operation) will be switched
off automatically.
• Press MENU/Automatic switch-off time.
Name: admin
• Enter the required period of time. (The pre-set name “admin” will be changed by the
administrator.)
Password: *****
(The pre-set Password: “*****” will be changed by the
administrator.)

If the name or password do not correspond during the log on

to the model stored in the memory, the device is set to the 6.8.2.2.1 SETTING THE MODE - INDIVIDUAL
lowest possible access level. The name is then set to "NL" = ACCESS RIGHTS/OPEN USER
No Login. It is not possible to start the cycle from this level.
New log on is necessary - correctly. After the device starting,
the last logged person authorised before the switching off The device could be set in the mode:
remains registered in the device. • Open User.
• Individual access rights (log on).
6.8.2.2 ADMINISTRATOR
The administrator has pre-set name to “admin” and Select the requested mode by the check button
password to “heslo”. The administrator (after log on) has, in Individual Access Rights in the upper part of the display
addition, some rights, as. (Administrator).
• Setting the mode “Individual access rights” or “Open User”.
• Passwords management and access securing.
• Daily Charge Counter. 6.8.2.2.2 PASSWORD ADMINISTRATION
• Optional analogue variable displayed in the third column in AND ACCESS SECURING
the table of variables displayed during the programme run.
If you are not a person with administrator rights to your
device, skip the whole chapter Administrator. On the right, on the Administrator button level, there is the
Default button, by which could be set the administrator name
If you are a person with administrator rights to your and password to initial values so, as they were pre-set.
device, log on as the administrator and press the MENU/ By the Administrator button, you can reach the
Administrator. “Administrator – Access securing” screen for administrator
name and password setting.
The primary display with the name “Administrator (on the

bottom bar) appears. Now, set by the Name: button the administrator name
for log on.
By the Name (LCD): button set the administrator name for
displaying on LCD and on the printer.
By the Password: ***** button set the administrator password
for log on.
Press the button for return to finish:
The display is again in the “Administrator” screen, the

administrator is still logged on, but now under a new name
and password, different from the pre-set values.

Repeat this procedure stepwise for all authorised users,

which will have the authorisation to operate the device on
the given working place.
Press the button for return to finish:
At the time of return, all data isstored in the device memory.

Example for setting the access rights of the user No.1 by
the administrator:
Setting for the mode - Individual Access Rights

On the right, on the Users button level, there is the Default
button, by which could be set the names and passwords of
all users to the initial values so, as they were pre-set.
By the Users button, you can reach the “Users – Access
securing” screen for setting of the names and passwords of
all users.
The User 1 will log in under the name “tom” and password
“1212”. His name will be displayed as “tomas”. Such user is
entitled to run the programmes except for P5; he may cancel
the error messages, set the device time, interrupt the running
programme, and change the programme parameters.
Setting for the mode - Open User
Maximal number of users is 20.

You can move now by the arrow buttons in the list of all
users. Every user has adjustable all rights, names and
password separately.
Now, set by the Name: button the name of user 1 for log on.
By the Name (LCD): button set the name of user 1 for for
displaying on LCD and on the printer. The setting of access rights for the user in the “Open User”
By the Password: button set the password of user 1 for log on. mode is similar as in the previous case.
On the panel, on the right up, set the rights of the user 1 for the:
- error cancellation; Only the services selection has different sense:
- access to the chip card; - error cancellation;
- time change; - access to the chip card;
- programme interruption; - time change;
- change of programme parameters. - programme interruption;
The selected service becomes accessible for the given user - change of programme parameters;
by the check button and it will be protected by the password The service, selected by the check button, is protected by
at the same time. the password in the “Open User” mode, other services are
On the panel down, set the rights of the user 1 for starting of free accessible. The name and password are common for all
P1 to P20 programmes. users in the “Open User” mode. Of course, the administrator is
allowed to change the name and password in the “Open User”
mode too.

6.8.2.2.3 DAILY CHARGE COUNTER 7 OPERATION FAILURES

If the Daily Charge Counter is pre-set in the device
configuration (service), the administrator can modify the Daily
Charge Counter after pressing the button Daily Charge 7.1 TECHNICAL SAFETY DEVICES
Counter. Use Auto Reset to set an automatic counter
zeroing. The counter will be zeroed on midnight. The Daily
Charge Counter works in parallel to the basic batch counter.
7.1.1 ERROR MESSAGES, UNLOADING

OF THE CHARGE IN CASE OF
FAILURE
In case of the fault report there is interrupted the running

sterilization cycle, there sounds the acoustic signal and
on the display it is listed the appropriate fault reporting, for
example:
6.8.2.2.4 CHOOSING A THIRD VARIABLE IN

THE RECORDING TABLE
The administrator can enter the third optional variable by means

of a switch on the Administrator screen. Such variable will be
then displayed in the table of variables recorded during the
programme run.
As well as in this case it is possible, if the nature of the fault
makes it possible, to terminate the interrupted sterilization cycle
and make accessible the sterilized material. The procedure is
similar as in case of the interruption of the running program.
6.9 AUDIT TRAIL Push the pushbutton OK. Indication on the display:
The function of Audit Trail (optional) is to save pre-defined

events during the sterilizer operation (e.g. error messages,
changes of the sterilization programme parameters, door
opening, sterilization switch-on and -off, user logging
change, date and time change, etc.) that are recorded
continuously to the memory card.
The records can either be read according to individual
periods, viewed or printed by means of an external PC
programme AuditReader. The Audit Trail function is
activated in the device configuration and runs automatically.
When working with AuditReader on PC, the screen Memory
Card must be displayed on the sterilizer (MENU/Protocol
History / Memory Card button).

operation).


NOTE
↵ pressure is displayed.It is applied only for units with the
built-in monitoring of the input media pressure. The sterilizer
The password is pre-set to empty line by the monitors the input media pressure continuously. In case of
manufacturer, in this case, a confirmation by the “Enter” an insufficient input pressure of some medium there appears
button is sufficient. The administrator is allowed to change the respective warning message, an acoustic signal is heard
the names and passwords. and the actual pressure is displayed. In case of an insufficient
The program, if the failure enables it, automatically terminates pressure of some input medium the start of the sterilization
itself within a controlled mode. There is performed a short program is blocked until the supply of the medium is restored.
drying, the pressure in the chamber is compensated to the The attendance is notified by the appropriate operational
atmospheric pressure and the door is unsealed. After that it message on the display. The insufficient media pressure
is possible to open the door and unload the charge from the is recorded into the printed sterilization cycle protocol. The
chamber. For two-door version apparatuses in this case it is actual media pressure values can be displayed on the display
possible to open the door only in the side of the loading of by the attendance, see the paragraph: Information, display.
material. The overview of the fault reporting (failures), which
cause the program interruption, see the Appendix to the
Direction for use. The cause of the failure must be removed 7.4 BLOCKING THE OPERATION IN
by service in most of cases. CASE OF ELECTRICAL ENERGY
DEFICIENCY
!
WARNING
In this case the material, which should have been The unit enables to block the startup of a sterilization cycle
sterilized, cannot be considered as to be sterile! or of the steam generator remotely in case of electrical
energy deficiency (energetic peak). In case the unit is
Some types of failures due to their nature do not blocked in this way there appears the respective informative
make possible the automatic program termination. message if someone tries to start it up.
In this case it is necessary the action of the service.
The removing of the sterilised material from the
chamber in this case makes also the service.
8 MAINTENANCE,
7.1.2 OPERATIONAL MESSAGE CLEANING AND
ATTENDANCE
The apparatus also notifies the attendance of incorrect
operation of the attendance or non-meeting the necessary
conditions, by means of the appropriate operational
(information) message on the display. The operational
!
message does not interrupt the sterilization cycle. WARNING Before cleaning you disconnect the apparatus from
the electric power supply. Perform cleaning in the
cold apparatus.
If the chamber or its environment could be contaminated by
7.2 ELECTRIC ENERGY OUTAGE pathogenic substances, they must be treated with a suitable
disinfectant before the service.
If a short-time outage of electric energy occurs during the
sterilization cycle and no infringement of the observed
parameters takes place, the sterilization cycle automatically 8.1 CLEANING
continues after the restoration of electric power supply. After
finishing the cycle the sterilizer load is considered sterile. In case of daily operation clean the interior of the sterilizer
In case of a longer outage of electric energy, an error is chamber and the outer surface of the unit at least once in two
reported after the restoration of electric power supply. weeks. Use only non-aggressive cleaning means for chromium
or stainless steeel without addition of abrasives which could
! cause scratching of the surface (for example, cleansers for
stainless steel dishes can be used). No aggressive cleansers
WARNING In this case, the sterilizer load can not be considered may be used to clean the external part of the device. For
sterile! cleaning of aluminium dishes or other aluminium parts, the
same agent as for tools cleaning can be used. All such cleaned
parts must then be washed in hot water.
7.3 OUTAGE OF INPUT MEDIA
PRESSURE (MEDIA MONITORING)
8.2 PRINTER ATTENDANCE
Holds only for units with the built-in monitoring of the input
media pressure.The sterilizer monitors the input media It applies only to devices in the version with built-in printer
pressure continuously. In case of an insufficient input (option) 9.2.1.
pressure of some medium there appears the respective
warning message, an acoustic signal is heard and the actual

• By slight pulling the movable lever of the cover, open the

8.2.1 SERVICING ELEMENTS printer cover. Thus the pressuring down roll of the paper
transport releases from the drive gear of the printing
On the front panel there are buttons drive. The cover can be opened easily now.
• Insert the paper roll into the paper cassette, outside

OFF/NEXT and FEED/ENTER and indication diode. with the sensitive layer, the end of the paper ca.10 mm
For routine operational attendance, i.e. paper loading and remains being pulled outside.
feed it serves only the button FEED/ENTER (paper feed).
If the button FEED/ENTER is pushed at the moment of the
switching on the power supply, the printer performs „test
after switching on“, which tests the basic functions of the
printer and prints a set of characters, found supply voltage
magnitude and version of the software - FIRMWARE. There
is not tested the communication with the controlling system.
8.2.2 INDICATION OF THE PRINTER

STATE
Two-colour luminous diode on the printer panel indicates the

state of the device.
• Firmly press the printer cover with both hands so as it
audibly snaps to the case lock. Now we can turn off the
Short green flashes (with changing - 1lights /3does not light) paper through the tearing off edge, without opening the
signals: cover and the dropping out of the roll.
• error-free state and functional readiness of the printer.
Red flashes alternate - 1 ligths /1 does not light) signalizes
one of the fault states.
• the end of paper;
• low operational temperature;
• high operational temperature;
• supply voltage out-off tolerance.
The accurate fault code is transmitted through the interface
to the controlling system (See technical documentation).
8.2.3 PAPER LOADING
• Unwind some turnings of paper off the paper roll, seize

this roll in such a manner, so as the respective paper
turnings would not loosen.
• The printer is ready to work.
Use the following paper: Thermosensitive paper DPA-
038-MG10, order number: 010096216, Thermosensitive
paper DPA-038-MG15, order number: 010447229 (15-year
guarantee of text eligibility).

Cleaning of the Sealing

8.3 SEALING SYSTEM OF THE Clean the sealing in warm soap water, use soft washrag
STERILISATION CHAMBER orcloth. Then rinse with potable water and dry.
Groove Cleaning
The device is manufactured in two versions, with two types Clean the sealing groove using a cloth and a standardmeans
of door sealing. The fixed sealing or the flexible sealing. for stainless steel (Vif, Cif etc.). Let the groove dryafter being
cleaned.
Sealing Lubrication
8.3.1 FIXED SEALING Apply a thin layer of the „Barierta“ lubricant on the sealing(supply
number BMT: 000613047).
It applies only to machine version with fixed sealing!Remove any
impurities from the door sealing. It isrecommended to use a wet Inserting the Sealing to the Groove
(foam) sponge for cleaning asit does not leave any impurities Put the sealing evenly to the groove. The glued joint mustbe
and textile fibres, hairs, etc.on the sealing – service staff. placed in the upper central part.It is important for the sealing to
be evenly distributed alongthe whole circumference and inserted
to the groove. It isnot allowed for the sealing to exceed the
groove front. Theinsertion procedure is shown in figure.
CAUTION Do not lubricate the door sealing and the door
surface!
8.4 TIME INTERVALS FOR
MAINTENANCE
8.3.2 FLEXIBLE / MOVABLE SEALING
Daily
• Clean the sifter for capturing the dirt in the chamber
bottom.
It applies only to machine version with flexible/ Monthly
movablesealing! Optimal function of the door sealing Treat the door sealing according to the procedure described in
system isconditioned by sealing and sealing groove chapter 9.3 – Sealing System of the Sterilisation Chamber.
maintenanceonce per month. It is recommended for the
sealing cleaning to be performed with slightly heated The check of the safety valves function shall be carried
sterilisation chamber,while the total time demands do not out as follows:
exceed 10 – 15 minutes.Cleaning and lubrication of the 1. Switch the unit on, start the program P6 - BD-test.
sealing may be performed bythe service staff based on 2. After the temperature has reached 134 °C disconnec the
training performed by the servicetechnician in compliance unit from the electric power mains !!
with the following procedure: 3. O pen the front device cover and turn the PV
capcounterclockwise. Protect your hands from burns
Taking the Sealing out of the Groove: bygloves. Lift the PV cone slightly till blowing and then
Carefully take the sealing out of the groove (the tool rescrewthe cap to its original position.
fortaking the sealing out is supplied together with the 4. If the SV function is correct, close the device cover.
device).Take care so as to avoid any damage of the sealing 5. If the funtionality has been found unsatisfactory, set the
andscratching of the inner surface of the groove! unit out of operation! After wards ensure a replacement of
the safety valve and then repeat the procedures 1 to 5.
CAUTION T
he safety valves function shall be checked by
Soporte de
la obturación an authorized person according to the national
regulations.
Obturación Half-yearly
de la puerta It is necessary to put the steam sterilizer after 800 cycles,
but no later than within every six months, to periodical
service inspection.
Instrumento
a quitar la Service inspection - contents:
obturación • After 800 cycles, but every six months at the latest,the
steam sterilizer must undergo a periodic serviceinspection
performed by a service technician.Service inspection –
description.
• Check the tightness of screwing, pipe joints, hoses andtanks.
• Check visually whether the sterile aeration filter fillinghas
CAUTION The sealing must not be damaged while beingtaken not been damaged and replace it if necessary.
out.Check the sealing for mechanical damage, wear • Check and set, if necessary, the anti-vacuum valve ofthe
and tearand hardness changes. In case of vacuum pump.
establishing anay of thefault, replace the sealing. • Check the lowest underpressure (vacuum) of thevacuum
pump.
• Check the temperature measurement equipment.
• Check the electric equipment, especially the

terminalconnector of the protective conductor.
• Check and set the switches, end switches, run and
CAUTION E
xcept for special cases (e.g. to prevent
wearof the chamber door closing mechanism.
• Perform the test run of the device and programme. somedamage or threat), the screws, screwed joints
etc. can onlybe tightened if there is no pressure in
Annually the device and thedevice is cold.
• Replace the door sealing preventively.
• Lubricate the door drive pin (this applies to fixed sealing Annually
only). The maintenance is the same as every six months and, in
• Clean the sifter for capturing the dirt in the inlet and addition to it:
outlet pipes. • Clean the screens for impurities catchment in the inlet
• Open the check valves, clean them and eventually and outlet piping - service. Check the inner space (visual
change the sealing. control and/or by means of an endoscope or mirror).
• Open and clean the condensate extract, eventually • Other measure are taken according to the ascertained
change the filler. device condition.
• Clean, eventually change the filter sleeve for sterile air inlet. • Open and clean the back valves and replace the sealing
• Perform the re-calibration of sensors. if necessary.
• Revision of electric parts Inspection of electric wiring,
especially the power supply, connecting and protecting
terminals. It is checked the consistency of the wiring
CAUTION Semi-annual and annual activities shall be
insulation (e.g. due to wearing through, burning etc.) and
a firm connection of wires in the terminals. Resistance of performed by an authorized person.
protecting connection is R < 0,1 ohm. The resistance of After 6,000 working cycles
power supply is not taken into account. • Inspection of the sterilization chamber.
• Perform the check of the battery voltage.
• Check the heating contactors (K4, K5) and replace them The sterilization chamber is a pressure vessel undergoingfatigue
stress due to a variable working pressure. Pressurevessels
after 4000 cycles at the latest.
undergoing fatigue stress must be monitored inaccordance with
EN 13445-3, Annex M.You can find a detailed description of
the inspection in theService Instructions.The inspection shall be
CAUTION
performed by an AuthorizedPerson – certified pressure vessels
Half-year and annual activities shall be performed inspector.
by an authorized person.
8.6 PUTTING THE DEVICE OUT OF

8.5 INTERVAL OF STEAM OPERATION
GENERATOR MAINTENANCE
If the device is to be put out of operation for a longer
Daily time(occasional use), we recommend to perform
• Visual control and operation test - operator. a sterilizationcycle with an empty chamber once in a week
• Visual control of the demineralised water supply at least.In case of a long-term putting the device out of
equipment - operator. operation,we recommend the device preservation by
a servicetechnician.
Monthly
• Check the function of the safety valve unless the national
regulation specifies otherwise. Procedure - see Chapter 9.3.
Every six months
• Generator sludging (complete discharge).Instructions for 9 STEAM GENERATOR
use.
• Open the storage tank of the supply water, checkvisually It is applied only for the apparatuses in the version with the
the storage tank and clean it if necessary. Check the built-in steam generator.
function of level meters. (It is expected that in the apparatus there is configured
• Check the function of the automatic boiler supply,security a steam generator).
in case of lack of water.
• Check the tightness of the piping joints and tighten
thescrewed connections.
• Sludge, clean and check the connecting pipes and
levelindicator chambers (B90, B91).
• Test the safety level limiter (B91 – in the
electricgenerator only).

9.1 STEAM GENERATOR OPERATION 10.2 CONSUMABLES
The steam generators are supplied with water by means ofa The consumables can be ordered under the following order
pump from a tank with regulated water level. The waterlevel numbers:
in the storage tank is controlled and monitored by means of Component name Order number
a level indicator S10. If there is not enough water,the supply
Door sealing 336 fixed 010094748
pump of the generator is blocked.
Door sealing 559 fixed 010446568
Electrical steam generator (ED) Door sealing 636 fixed 010108622
Water level in the boiler is checked by means of levelswitches.
Door sealing 336 – movable / flexible 010120942
The heating elements protection is doubled. Thelowest water
level is safeguarded by means of a safety levelswitch B91 Door sealing 559 – movable / flexible 010446762
(switch-on blocking).The supply water level is safeguarded Door sealing 636 – movable / flexible 010120943
by the level switchB90 which has a protective function as Aeration filter 000538626
well. If the level isnot automatically filled within the time limit Cleaning
(approx. 40 s),the generator heating is switched off reversibly. Cleaning means: 000544308
If the switchB90 is not submerged (enough water is pumped) „ Ultrapur sprey „- face panels 000644375
for morethan approx. 4 minutes, a breakdown is announced.
The generator is pressure-controlled by means ofa pressure „ Cif „- chamber 010096216
converter.The generator heating elements are protected Termosensitive paper DPA-038-MG10 010447229
againstoverheating (e.g. operation without water) by means ofa for printing
thermostat TE1. Chip card UNISTERI® HP 010445887
Adjusted supply water must be used for the steamgenerator.
The limit conductivity value of completelydesalted water
withdrawn from the water-treatment plantis max. 15 μS/cm at
water temperature of 20 °C (seeChapter 12.2.2). The values are
generally read directlyInstructions for use from the measurers
placed at the water desalting facility.Even though the generator
11 STERILIZER
is supplied with treated water,salt concentration in the generator
increases gradually dueto the boiler water evaporation. Such
INSTALLATION
salt concentrationwhich is harmful to the generator pressure
vessel material,causes corrosion (so called pitting corrosion).
It is thereforenecessary to desalt the generator regularly. Partial
desalting of the generator is carried out automaticallyat each CAUTION T
he sterilizer may be installed and put into
supply water filling when the desalting valve Y99 isopened for
operation by an authorized person only.
about 3 seconds.The generator sludging (complete emptying)
must beperformed every six months at least.
11.1 BUILDING SITE PREPARATION

AND REQUIREMENTS
10 ADDITIONAL MATERIAL Dimensions
AND CONSUMABLES The preliminary construction works must be
performedaccording to the BMT Installation Plan. The
dimensions arein millimetres and represent “net dimensions”
(plaster ortiling included).The device must be accessible for
service from the side(service area).If it is not possible from
space or other reasons, the deviceshould allow forward taking-
10.1 STERILIZATION CHAMBER off (one-door model). Forthis purpose, it can be provided with
EQUIPMENT wheels (optionalequipment) making the handling easy. The
device isconnected by means of flexible connectors.
As standard, the sterilizer is supplied with a basic insertallowing Installation area for the sterilizer
to place there 1 container of 1 ST size. Otherequipment can The seating surface shall be plane and horizontally
be supplied, e.g. the shelf system, BW andTW loading carts, balanced. The floor shall be made of hard, leakproof
solutions tank etc. (optional equipment). material (paving, concrete, cast floor with satisfactory
hardness, etc.).
11.2 REQUIREMENTS ON SERVICE

CONNECTIONS
Requirements towards operation media are based on

requirements and recommendations of EN 285.

11.2.3 DRAIN - A
CAUTION Not keeping the quality requirements on service The waste piping must be provided with a disconnecting
media negatively influences the unit‘s functionality trap. The waste pipes material must withstand the
and consequently causes the need of more temperature of 100 °C; see EN 285. This condition must be
frequent servicing. This may lead to a limitation of complied with only in the variant without the waste water
the warranty period or even to refusal of the aftercooling equipment.
warranty as a final consequence.
11.2.4 ELECTRIC POWER

11.2.1 COOLING WATER (FOR THE CONNECTION - E
VACUUM PUMP) - KW
Check the network connection voltage before connection
Feed water for the vacuum pump should meet the national and compare it with the type label data. The voltage and
requirements on drinking water. The water temperature shall frequency must comply. The electrical installation shall meet
be within the range 5 - 20 °C. If the water hardness exceeds the valid national regulations. a protective terminal in the lower
the value of 2 mmol/l it is absolutely necessary to install part of the unit‘s frame serves for increased protection by
a water treatment device.The water supply connection shall interconnection. a three-phase main switch, easy accessible by
be provided with a closing cock. the operator and with clearly marked switching positions ON -
OFF, shall be installed in close proximity of the unit.
Switch:
- must meet the requirements of IEC 947-1,IEC 947-3,
11.2.2 FEED WATER FOR THE STEAM - must not disconnect the protective wire.
GENERATOR - DW Dimensioning of the switch - see the „Installation plan BMT“.
For the steam generator supply, distilled and fully

demineralised water must be used, or water must be treated 11.2.5 PRESSURE AIR - DL
by means of reverse osmosis. The electrical conductivity of
the supply water must be max. 15 μS/cm. The water mains This is applied only to sterilizers with a cooling jacket. The
pipe must be provided with a stop-cock. Other parameters The pressure air shall be free of water a oil droplets. It shall
of the supply water must comply with the requirements of not contain solid particles larger than 25 μm. The service
the standard EN 285. connection shall be provided with a closing cock.
Contaminants Condensate Feed water
(steam) (generator)
Evaporation residues ≤ 1,0 mg/kg ≤ 10 mg/l
Silicium oxide SiO2 ≤ 0,1 mg/kg ≤ 1 mg/l 11.2.6 STEAM FOR STERILIZATION - FD
Iron ≤ 0,1 mg/kg ≤ 0,2 mg/l
Cadmium ≤ 0,005 mg/kg ≤ 0,005 mg/l To operate the device by the steam from the central
Lead ≤ 0,05 mg/kg ≤ 0,05 mg/l distribution, it is necessary to secure a professionally made
Heavy metals except iron, ≤ 0,1 mg/kg ≤ 0,1 mg/l distribution and the steam quality (see table in Chapter 11.3).
cadmium, lead The last condensate extract should be placed max. 2 m from
Chlorides (Cl`) ≤ 0,1 mg/kg ≤ 2 mg/l the device. The steam may contain, according to the EN 285
Phosphates (P2O5) ≤ 0,1 mg/kg ≤ 0,5 mg/l max. 3,5% V/V non-condensed gases, the dryness may not
Conductivity (at 20 °C) ≤ 3 μS/cm
be lower than 0,9 and the overheating of the free streaming
≤ 5 μS/cm1)
steam at the atmospheric pressure may not exceed 25 K.
pH value 5 up to 7 5 up to 7
The connection must be equipped by the stopcock.
Appearance colourless clear colourless clear
without sediments without
sediments
Hardness 11.2.7 SOFTENED WATER (FOR
(Σ ions of alkalin earth)
HOUSING COOLING) - EW
1) The recommended electrical conductivity according to the
standard EN 285 is 5 ≤ S/cm. Such conductivity, however, is not
required by UNISTERI® HP devices. Is valid only for the sterilizer variant with the cooling housing.The
softened water is necessary for the housing cooling. Hardness ≤
0,1°d. Water connection must be equipped by the stopcock.
CAUTION Use of supply water or steam with parameters

exceeding the values specified herein can shorten
the device life or set considerable limits to the
manufacturerguaranteed parameters. It can be
a reason for the guarantee cancellation by the
manufacturer.

11.3 DEVICE ASSEMBLY AND 11.4 TRANSPORT INSTRUCTION

PUTTING INTO OPERATION
The device assembly and its first putting into operation may
!
only be done by an authorized person. WARNING
• It is recommended to demount the side and bottom tiling • The upper part of the device is heavier. Beware of
before the device is put down from the pallet. overturning!
• When putting the device down from the pallet and handling • Depending on the model, the device can be equipped
it, hold only the fixed parts – the frame or the chamber. with travelling wheels (optional equipment) for easier
When handling the device, do not hold the face panels! moving. Such wheels are not intended for long
• The device can be moved on a hard and flat floor by means transport but for local moving only!
of integrated wheels. • When putting the device down from the pallet and
• Connect the hose connectors. Roughen the threads and handling it, hold only the fixed parts – the frame. When
wrap teflon tape around them except for the first thread. The handling the device, do not hold the face panels!
drain must be connected first. • The device has adjustable legs by means of which
• Place the device accurately to its position and install it it can be levelled at the site and fixed. Pull out the
by means of adjustable legs (the screws M10 should be legs by means of screws (M10) so as the travelling
secured against loosening by means of nuts). If the bottom wheels were approx. 1-2 mm above the floor.
face panels were demounted, remount them on the device.
• Connect the electric cable plug to the socket.
• Hoses must be positioned in the device to form large bends;
the discharge hose must not warp above the discharge
elbow-pipe on the storage tank.
• Open the closing valves. Check the installation junctions 12 TRANSPORT
sealing.
• Switch on the main electric switch on the outer power supply. AND STORAGE
• Check whether the device is in the “Ready-to Start” status.
• Switch the device on.
• Take out immediately the objects stored during the transport
in the chamber (instructions for use, revision log, etc.)!
• Check the basic device setting in the service menu. 12.1 TRANSPORT
• Check the door closing function.
• Wait till the generator is filled and pressurized to approx. The unit is being prepared for transport by an authorized
3.4 bar (absolute pressure). Manual filling of the generator person, who also dismounts the service connections. The
is recommended under concurrent monitoring of the level unit shall be transported in its original package.
indicator NW, HW by means of service menu.
• Carry out the V-test.
• Carry out the test sterilization programme.
!
WARNING The upper part of the device is heavier. Beware
• Check the setting of all temperature and pressure sensors
(in heated condition); recalibrate them if necessary. of overturning!
• Carry out the test sterilization programme.
12.2 STORAGE
11.3.1 BEFORE THE FIRST DEVICE USE
For storage the unit is being prepared by an authorized
person who dismounts the service connections, drains off
the pipework and storage tanks and dries them by pressure
CAUTION air. The sterilizer shall be put in its original package. The
The technical documentation, sterilizer storage temperature shall not drop below 4 °C.
components and equipment in a plastic pack are
placed in the sterilization chamber for transport.
Do not forget to take them out immediately after
the sterilizer is placed to its working site. When
opening the sterilization chamber, follow the
instructions of Chapter 7.1, 7.2 and 7.3.
13 WAY OF LIQUIDATION
13.1 PACKAGE
The package is made of wood, nails, cardboard, paper and

plastics, which can be recycled as like as household waste.
The materials may be recycled in full.

to consumer material, such as e.g. door sealing, materials for

13.2 UNIT recording devices, accumulators etc. If a defect occurs, draw
claims to a warranty repair directly at the nearest BMT service
For European Union countries: center. Please mention the device name and type, its serial
A product which is no more in use, is of no use for the and number and how the defect appears (error message, printer
record). Provided the warranty conditions are fulfilled there
follows, according to the consideration of the service center,
the cost-free repair or replacement of the defective part.
If the prescribed maintenance is complied with, the device
has the labelling, shall be shut down by the life exceeds 10 years. At the same time, this is the period for
user who shall inform the seller (in the Czech Republic: the which the manufacturer bears objective responsibility within
manufacturer). The product can not be put into communal the meaning of EU Directive no. 85/374/EEC for any potential
waste and it is subject to relevant mode of operation pursuant damage caused by the device operation. If you decide to
to the WEEE directive. continue using the device after the said period expiration, ask
the manufacturer or an authorized service for an expertise
For countries out of European Union: whether or not the device can still be used regarding its wear
and tear, technical condition and service availability.
The label is valid in European Union countries

only. Ask your authorities or the device seller for detailed 16 SUPPLEMENT
information about correct liquidation of electric and
electronic devices.
16.1 STERILIZATION OF SOLUTIONS

IN OPEN BOTTLES WITH SELF-
COOLING
14 REGULATIONS AND
STANDARDS It applies only to devices designed for solution sterilization with
self-cooling, equipped with appropriate option and program.
From the viewpoint of requirements on design and

manufacturing of electrical appliances and pressure vessels 16.1.1 SIMPLE STERILIZATION
this sterilizer fulfills all legal regulations, harmonized standards
and recognized rules (see EU Conformity declaration that is
OF SOLUTIONS
an inseparable part of the documentation supplied along with
each device) and is provided with all necessary safety, check This program is a simple optional program for sterilization of
and operation mechanisms. solutions in open bottles with a movable sensor.
Deaeration is of gravity type or, if wished, of forced type with
one simple evacuation. a movable sensor submerged in the
reference bottle scans the temperature of the liquids being
sterilized. The real sterilization exposure is not started until
15 WARRANTY the sterilization temperature in the bottle has been reached.
Spontaneous cooling follows the sterilization exposure. The
AND SERVICE parameters of the sterilization cycle (evacuation, sterilization
temperature, duration of sterilization exposure etc) can be
modified on request of the customer. As the temperature is
The guarantee period is marked on the certificate of scanned by a movable sensor in the reference bottle, it is
warranty. The warranty refers to manufacturing defects or necessary to ensure that the temperature in this bottle will
material defects on condition that: not become higher than the one inside the remaining load
• the product has been installed and used in accordance (for example by replacing the reference bottle or its content
with the Instructions for use, before each sterilization cycle).The temperature sensor is
• the cause of the defect was not a insufficient located in the reference bottle by dipping it at least 20 mm
maintenance, unqualified intervention in the device or into the liquid being sterilized.
damage through external impacts. The reference bottle is a bottle of the same volume and
The warranty does not relate to natural wear of material and containing the same liquid as the other bottles being
sterilized. The reference bottle is not a part of the sterilizer
delivery. In case of sterilizing liquids in small bottles, it is
permitted to choose a reference bottle with a volume large
enough to get the temperature sensor in. The reference
bottle is located in the lower part of the sterilization chamber
(theoretically the coolest part).
It is recommended to fill the bottles to be sterilized only
up to two thirds of their volume to avoid overboiling of the
content over the edge.

When using the program with evacuation, the initial

temperature of the sterilizer load shall not exceed 25 °C
16.2 SOLUTION STERILIZATION WITH
and the sterilization cycle shall be started immediately after THE FORCED HOUSING COOLING
inserting the load into the sterilization chamber in order to
avoid undesirable pre-heating and subsequent boiling of the Is valid only for the device variants with the forced
liquids during the chamber evacuation. housing cooling and air back-pressure (additive). After the
The sterilizer is not designed to sterilize aggressive liquids sterilization exposition, the cooling phase follows, when the
which would cause corrosion of the sterilization chamber cooling water (softened) is filled into the sterilizer housing
surfaces! by a controlled manner. The pressure in the sterilization
chamber is kept on proper level by an air back-pressure
during the cooling phase. The incoming pressure air is
filtered by a Bacteriologic Filter (PALL Company).
16.1.2 STERILIZING OF SOLUTIONS This cooling way enables to shorten the cycle cooling phase
WITH FO PARAMETER significantly.
This program is designed for sterilization of solutions with the

Fo parameter (additive). 16.3 ARNOLD STEAMING
Applicable only for devices for sterilizing with Fo parameter PROGRAMMES
(additive). This method of controlling is destined for the
sterilization of solutions and as well as it uses the movable Valid only for devices equipped with Arnold programmes
temperature sensor. (optional).
The Fo value of sterilizing procedure with saturated vapour 1. A
RNOLD - 97 °C (standard): Works at nominal
using is the lethality, expressed as the corresponding temperature of 97 °C with tolerance up to +4 °C; basic
time in minutes by the temperature of 121 °C in relation exposure setting: 10 min.
to the animalcules, having value of Z=10 by sterilising of 2. A
RNOLD - 75 °C (low-temperature): Works at nominal
the product and its final packing. The Fo value can be temperature of 75 °C with tolerance up to +4 °C, basic
interpreted also as the value of time in minutes, necessary exposure setting: 10 min. This programme differs markedly
for reaching the equivalent sterilising effect by standard from the standard sterilization and disinfecting programmes.
temperature of 121 °C. It differs mainly by working pressure which ranges in the
The total Fo value of the procedure considers each of underpressure region nearly for the whole period. During
heating and cooling phases of the cycle and can be exposure (75 °C), the working pressure is about -45 kPa
calculated by integration of lethal values of each of (relative pressure).
temperature periods in consideration of their duration
time. Software enables to enter the required value of Fo
parameter by using of the service programme. The real
sterilization is implemented at the temperature of 121 °C CAUTION ARNOLD - 75 °C (low-temperature) programme is
as a standard, but any other program, outlined for different
a steaming programme with a very low working
basic temperature can be used optionally.
temperature. In case of its use in combination with
The real sterilizing exposure is finished after reaching of concurrent use of sterilization programmes, the
default Fo value; the program will pass subsequently to the following operation rule, therefore, must be observed
cooling period. In this period the calculation and integration so as to ensure sterilizer’s cooling to working
of the Fo value proceeds as well. The integration calculation temperature before the use of the said programme.
of the Fo parameter is implemented with the period of 1s. In
a) We recommend to use ARNOLD - 75 °C lowtemperature
the record, the Fo parameter is recorded at the end of the
programme as the first one when the device is still cold,
sterilizing exposure (corresponds to the default value). The
for example, immediately after VT test when the sterilizer
digital record on the printer contains besides of record of
has not been heated by any previous sterilization cycle.
corresponding pressures and temperatures also the record
b) After you switch the device on, select a low-temperature
of actual Fo value.
programme (ARNOLD - 75 °C or VT test) so as to
To the advantage of this method there belongs a shortening
avoid automatic heating of the chamber jacket to high
of the cycle, defined exposition, lower thermal stress and
temperature. (This means selection of the programme
worn of the sterilized material together with keeping the
only; of course it is not necessary to switch the
sterilization efficiency.
programme on immediately.)
c) If a standard sterilization cycle (with high working
temperature) was used before, let the heated ARNOLD -
75 °C (low-temperature) programme and chamber door
open for 60 minutes at least! Then put material into the
chamber and switch ARNOLD - 75 °C (low-temperature)
programme on.

16.4 LARGE DISPLAY (LCD) ON THE 16.5 PROTOCOL OF STERILIZATION

UNLOADING SIDE AS WELL PROGRAM
Valid only for devices provided with another large display Output protocol example:
(LCD) at the unloading side (optional). This modification
allows full comfortable control of the device as well as the
sterilized material flow from both sides (according to the
device setting).

16.6 UNICRASH TYPE PROGRAMME
Valid only for a Unicrash-type programme models (optional).

The Unicrash-type programme allows implementation of some
additional procedures like e.g. pressure crash test, methylene
test, rinsing (material flooding with water + air bubbling), shower,
heating before drying, material drying. The general course of
the cycle is shown on the drawing no. KV - 487. A programme
of this type can either be started manually as a separate cycle
or can be included in (connected to) a standard sterilization
programme. In such case, Unicrash type programme shall
automatically be carried out after the end of the appropriate
sterilization programme.

16.7 ERROR REPORTING

If on the display there repeatedly appears the error reporting, it is necessary, after setting the password for the error confirmation, to
switch off and again switch on the electricity supply. If the error continues to exist, please, proceed according to the following table.
After pressing the button the service technician can suppress errors for up to 999 seconds (repeated pressing).
Error Description Debugging Who
Fatal Error Incompatible SW or HW 1. Load correct SW into all the Service

electronics boards
2. Replace the faulty electronics
board
Discharged Battery The voltage of the battery decreased below Replace the battery Service
2,7 V
Device Configuration After loading the bios, or after replacing the Set the correct configuration of the Service
Corrupted boards VP_CPUM or VP_CPUS device
Offsets Of Analog After loading the bios, or after replacing the Set the correct offsets Service
Values Corrupted boards VP_CPUM or VP_CPUS
No Connection Between Faulty communication between VP_CPUM 1. Check the cables for RS 485 Service
Mst And Bck Boards and VP_CPUS or VP_CPUB 2. Check SW in all the electronics
boards
3. Replace the faulty electronics
board
No Connection Between Faulty communication between VP_CPUM 1. Check the cables for RS 485 Service
Mst And Slv Boards and VP_CPUS or VP_CPUB 2. Check SW in all the electronics
boards
3. Replace the faulty electronics board
SG Pressure Switch High pressure in the generator 1. Check the switching of the Service
heating
2. Check the pressure switch B31
Water Level In The Switch B91 is not flooded with water for 1. Check the demi water supply Operator /
Steam Generator longer period than 250 sec. 2. Check B91 Service
3. Check the VP_CPUS electronics
board
Door 1 Unsealed The door on the loading side is not sealed 1. Check the door sealing Operator /
2. Check the valve Y09 Service
Door 2 Unsealed The door on the unloading side is not 1. Check the door sealing Operator /
sealed 2. Check the valve Y09 (Y09.1) Service
(B20.1)
Door Sealed The door is sealed 1. Wait for the door to be unsealed Operator /
2. Check B20 and B20.1 Service
High Steam Generator High Steam Temperature in the Generator 1. Check the pressure sensor PE3 Service
Temperature 2. Check the temperature sensor
PT4
3. Check the printed circuit board
VP_CPUS
4. Check the contactors K4-7
UNISTERI HP_np_en 2018-09_V4.00 41/44

High Chamber High steam temperature in the chamber 1. Check the door sealing Operator /
Temperature 2. Check the inlet steam Service
3. Check the valve Y07
4. Check temperature and pressure
sensors
Low Chamber Low temperature in the chamber 1. Perform the vacuum test. Start Operator /
Temperature again the cycle Service
2. Remove untightness
3. Check the condensate trap
4. Check the process parameters
5. Check the temperature and
pressure sensors
Phase Too Long The specified phase of the sterilization 1. Check the input media Operator /
cycle is longer than permitted 2. Check the inputs and outputs Service
Air In The Chamber - The quantity of gases unable to condensate 1. Check the sealing Operator /
Failed is above the limit 2. Check the tightness of joints Service
Voltage 24 V The voltage 24 V decreased 1. Check the fuse F4 Service
below 17 V 2. Check the door seal
3. Check the door motors
4. Check the pressure sensors
VP_CPUS and VP_PDC
Pressure Sensor Pressure sensor disconnected 1. Check the sensor and its Service
Disconnected connection
VP_CPUS
Pressure Sensor Over Pressure sensor is above limit 1. Check the sensor and its Service
Limit connection
VP_CPUS
Demi-Water Level Switch B86 is not flooded for over 180 s 1. Check the demi water supply Operator /
2. Check the sensor B 86 Service
Methylene Level B102 Switch B102 is not flooded for over 5 s 1. Check the methylene supply Operator /
2. Check the sensor B 102 Service
EEPROM Error It is not possible to read or write to 1. Switch the device off using the Operator /
EEPROM on some electronics board main switch and switch it on Service
again after 10s
2. Check connections and
electronics boards
Door 1 Not Closed Door 1 not closed 1. Close the door Operator /
Properly 2. Check the door sealing Service
3. Check the door switches
Door 2 Not Closed Door 2 not closed 1. Close the door Operator /
Door Not Closed Door not closed 1. Close the door Operator /
Water In The Chamber Water remains in the chamber after the 1. Check the waste piping including Service
cycle termination valves
2. Check the level meter S1
Watch Dog At Process VP_CPUM processor board function failed 1. Re-start the cycle Operator /
Time 2. Check the VP_CPUM… board Service

Solitary Slv Reset There was a processor reset on the 1. Check the VP_CPUS board Operator /
VP_CPUS board without resetting the 2. Check the supply voltage Service
VP_CPUM board 3. Remove a potential source of
electromagnetic interference
Fatal Error Slv VP_CPUS processor board function failed 1. Re-start the cycle Operator /
2. Check the VP_CPUS board Service
File Creating Error It is not possible to write on the SD card 1. Check the SD card Service
2. Check the VP_CPUM… board
3. Check the VP_KON board
Manual Valve V36 Or Valve V36 or V37 is not closed 1. Close the valves V36 a V37 Operator /
V37 Not Closed 2. Check the switches SV36 and Service
SV37
Door Sensor S11 The door switch S11 changes the value in 1. Open and close the door and start Operator /
the course of the cycle a new cycle Service
2. Adjust the switches S11
Door Sensor S13 The door switch S13 changes the value in 1. Open and close the door and start Operator /
the course of the cycle a new cycle Service
2. Adjust the switches S13
Door Driving Mechanism The door does not reach the limit switch 1. Check (lubricate) the door sealing Operator /
within specified time period 2. Check the door sensors Service
Unauthorized System Repeated trial of unauthorised person to An authorised person to unblock the Operator
Access access device using a valid name and
password
Mismatch In Mst/Bck Discrepancy in the memory of processors 1. Login as an Admin, change Operator /
Flash Memory - CFG Master and Back - offsets, configuration, anything in access rights and Service
access rights save it
2. Save configurations again
3. Save offsets again
Mismatch In Mst/Bck Discrepancy in the memory of processors Change some parameter in Operator /
Flash Memory - PRG Master and Back - program parameters the "Program Download" (e.g. Service
fast select) and save it
High Pressure In The At the time when the cycle is not running Check the valves Y80 and Y80.2 Service
Chamber the pressure in the chamber rises above
200 kPa
Temperature Sensor Temperature sensor disconnected 1. Check the sensor and its Service
Disconnected connection
VP_CPUS
Temperature Sensor Temperature sensor short circuit 1. Check the sensor and its Service
Short Circuit connection
VP_CPUS
Fo Parameter The value of the Fo parameter is outside Eliminate the source of interference on Service
the expected range the temperature transmitter
Program For User The user is not authorised to start the A user with sufficient authorisation Operator /
Disabled program must log in Service
Invalid Content ! The protocol has invalid content, the x Operator /
original protocol has been changed Service
See 'System Version' For a more detailed specification, see the x Operator /
'System version' Service
UNISTERI HP_np_en 2018-09_V4.00 43/44

Message Description Remedy Who
Vacuum Pump Circuit Breaker The Q1 breaker is switched off 1. Switch on the breaker Service
2. Check the vacuum pump
Water Pump Circuit Breaker The Q2 breaker is switched off 1. Switch on the breaker Service
2. Check the pump
Methylene Pump Circuit The Q3 breaker is switched off 1. Switch on the breaker Service
Breaker 2. Check the pump
Steam Generator Turned Off The generator is switched off Switch on the generator Operator
Steam Generator Turned On The generator is switched on Switch off the generator Operator
Saving Failed, Repeat Action! Saving failed 1. Repeat saving Operator / Service
2. Check connection and
electronics boards
Door Sealed The door is sealed 1. Wait for the door to be Operator / Service
unsealed
2. Check B20 and B20.1
Service Door Is Open Service door open 1. Close the door Operator / Service
Door 1 Security Bar Activated Door 1 Security Bar Activated Check the protective strip Operator / Service
Door 2 Security Bar Activated Door 2 Security Bar Activated Check the protective strip Operator / Service
Door Security Bar Activated Door Security Bar Activated Check the protective strip Operator / Service
Atmospheric Pressure Error, Atmospheric Pressure Error, Open The Open the door Operator / Service
Open The Door Door
Program For User Disabled The user is not authorised to start the A user with sufficient Operator / Service
program authorisation must log in
Insufficient Rights For This The user is not authorised to start the A user with sufficient Operator / Service
Action action authorisation must log in

... excellence
in medical,
laboratory
and pharmaceutical engineering
Manufacturer: Distributor:
BMT Medical Technology s.r.o.

Cejl 157/50, Zábrdovice
CZ 602 00 Brno
tel.: +420 545 537 111
fax: +420 545 211 750
e-mail: mail@bmt.cz
www.bmt.cz

UNISTERI HP - NP - en 2018-09 - V4.00

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UNISTERI HP ®

Instructions for use

UNISTERI HP_np_en 2018-09_V4.00

The Instructions for Use

4 DESCRIPTION OF THE UNIT ......................................................................................... 10

9 MAINTENANCE, CLEANING AND ATTENDANCE....................................................... 30

11 ADDITIONAL MATERIAL AND CONSUMABLES......................................................... 34

12 STERILIZER INSTALLATION ......................................................................................... 34

13 TRANSPORT AND STORAGE........................................................................................ 36

15 REGULATIONS AND STANDARDS................................................................................ 37

chart of tubular interconnection, unisteri hp 336:  11000151826, 11000151825, 11000162159,

1 EXTENT OF VALIDITY • Pay attention to Chapter Operation of the unit

The temperature of door opening in case of sterilisation of

! 1601 - 2000 m 88,5 °C 73 °C 83 °C

UNISTERI HP_np_cz 2018-09_V4.00 7/44

1.1 INTENDED PURPOSE 2.1 PERFORMANCE CHECK

Steam sterilizers are provided with the possibility to print

8/44 UNISTERI HP_np_en 2018-09_V4.00

heavy accessible parts easier. Mutually connected instruments

2.2 PREPARATION OF 2.2.3 RUBBER LOAD

UNISTERI HP_np_cz 2018-09_V4.00 9/44

• easy and comfortable operation,

Technical data of pressure equipment are contained in the

Information for continuous checking of the pressure vessel

10/44 UNISTERI HP_np_en 2018-09_V4.00

• Operating level indicator in the generator for switching

The device is equipped with a 9-pin Canon connector (RS232) to

Depending on the model, the sterilization chamber is

Sterilizers can be, according to the order, equipped with a shelf

UNISTERI HP_np_cz 2018-09_V4.00 11/44

4 SPECIFICATIONS 4.2 INDICATING AND OPERATING

4.1 TECHNICAL SPECIFICATIONS

Dimensions of the sterilization chamber:

12/44 UNISTERI HP_np_en 2018-09_V4.00

4.2.2 THE SIDE OF UNLOADING 5.3 UNIVERSAL CONTAINERS

Sterilization program with parameters:

The Bowie-Dick test is a test of steam penetration. It is

5 PROGRAMS - BASIC 5.6 VACUUM TEST VT

Expulsion of the air from the sterilization chamber, first of

UNISTERI HP_np_cz 2018-09_V4.00 13/44

5.7 INSTRUMENTS QUICKLY 6 ATTENDANCE OF THE

5.9 PROGRAMS USE

The sterilizer user is responsible for correct choice of sterilization

14/44 UNISTERI HP_np_en 2018-09_V4.00

• Switching on the apparatus. Press a touch display

• The other possibility of the program selection is pushing

6.3 THE DEVICE OPERATION

6.3.1 INSERTING THE MATERIAL AND

• Open the door from the side of inserting the material

• Push the button Start.

Selection of the program

UNISTERI HP_np_cz 2018-09_V4.00 15/44

• Completing of the sterilization cycle is indicated In case of double door apparatuses:

• Unload the sterilized material.

• Unload the sterilized material.

The apparatus is switched off into the standby state.

16/44 UNISTERI HP_np_en 2018-09_V4.00

In case of two-door apparatuses it is possible to open the

If for whatever reason it is necessary to interrupt the

6.6.1 ACTUAL OPERATIONAL

• For the display of the actual operational information push

• Enter the name (only if it is requested in given mode of

UNISTERI HP_np_cz 2018-09_V4.00 17/44

chart of tubular interconnection, unisteri hp 336: 11000151826, 11000151825, 11000162159,

• Language - s election of the language of the