From start to dry in the blink of an eye. STATIM® Autoclaves.

Transcription

From start to dry in the blink of an eye. STATIM® Autoclaves.
ll y
fractionated vacuum steriliser
HYDRIM M2
HYDRIM L110
washer/disinfector
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BRAVO
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26793_SciCan_Opthamology_Layout 1 16/01/12 8:08 AM Page 1
C o m p li
a
Bravo17 (220-240V, 10A 50 Hz, Printer)
Bravo17V (220-240V, 10A, 50Hz, Printer)
Bravo21V (220-240V, 10A, 50Hz, Printer)
OPTIM 33TB
AQUASTAT
surface cleaner
and disinfectant
water distiller
From start to dry in the blink of an eye.
STATIM ® Autoclaves.
Think of how many procedures you could perform in a day.
Manufactured by:
SciCan GmbH
Wangener Strasse 78
88299 Leutkirch
GERMANY
Tel.: +49 (0)7561 98343 - 0
Fax.: +49 (0)7561 98343 - 699
SciCan, Inc
701 Technology Drive
Canonsburg PA, 15317
USA
Tel.: 724 820 1600
Fax.: 724 820 1479
Toll free: 1-800 572 1211
STATIM, HYDRIM, and OPTIM are registered trademarks and Your Infection Control Specialist, AQUASTAT, and BRAVO are trademarks of SciCan Ltd.
Not all products available in all markets. Contact your local SciCan dealer for product availability.
STATIM 5000S
SD-224/2-EN 2M 08/11
SciCan Ltd
1440 Don Mills Road
O 1 2 3 Toronto, ON M3B 3P9
CANADA
Tel.: +1 416 445 1600
Fax.: +1 416 445 2727
STATIM 2000S
STATIM 5000 G4
STATIM 2000 G4
26793_SciCan_Opthamology_Layout 1 16/01/12 8:09 AM Page 3
Sterilise your micro instruments and Phaco handpieces
between patients in only 15 minutes and protect them
from heat and corrosion.
How does STATIM work so fast?
The removal of air has long been
recognised as critical to
achieving sterilisation because air
acts as a barrier to the heat
(steam) reaching and killing the
micro organisms. In fact, unless
the steriliser can evacuate air from hollow or
wrapped instruments before sterilisation begins,
100% biological kill cannot be achieved.
Pressure/Time Comparison Graph
5x
faster
The STATIM ® 5000S and 5000 G4 cassette autoclaves are the
sterilisers of choice for ophthalmologists worldwide because they
are the most gentle and feature the fastest sterilising process
available today. STATIM will enable you to treat every patient with a
complete sterile tray freshly sterilised at the Point of Care inside
the theatre.
The European Standard recognises that there is
more than one way to achieve the removal of air.
The extremely gentle action of the STATIM-cycle
displaces air from the sterilisation chamber by a
patented steam-injection, positive pressure pulse
displacement process. This STATIM process is at
least five times faster than the typical 45-70
minute cycle of conventional B-cycle vacuum
autoclaves.
With a complete sterilisation cycle of only 15 minutes, STATIM will
optimise operating theatre and clinical time management, improve
efficiency and reduce turnover time for all ophthalmology operations
and procedures including refractive and cataract surgery.
Reduce Costs
You could also reduce your investment in Phaco handpieces and
micro instruments due to the faster sterilising turnover time.
Point of care: A fresh set of sterilised instruments and handpieces for every patient.
The gentle action of the STATIM – unique among sterilisers – will
cause virtually no corrosion or heat damage to your valuable
handpieces and instruments. It’s a new formula! Speed equals
money saved and increases the number of daily surgical
procedures, without any additional investment in instruments.
Sterilisation
complete
prior to drying
Sterilisation
complete
prior to drying
Super-atmospheric
100 kPa
Sub-atmospheric
0
Minutes
20
8.5 10
30
40
Minutes
STATIM 2000S Autoclave (Hollow/Unwrapped (S) 134˚C/3.5 min)
Typical B Cycle Vacuum Autoclave (standard 134˚C/3.5 min Universal B Cycle)
(Cycle times are from warm start and load dependent)
When the ‘start button’ is pressed, the steam generator heats to the optimum temperature and a defined volume of good
quality, distilled water is pumped in and converted to steam. Then, a gentle, non-turbulent wall of steam is automatically
injected into the cassette pressure chamber which is loaded with contaminated instruments. Air is purged as the steam
courses through the cassette and is continuously expelled into a waste bottle. After any cycle is completed the drying cycle
automatically switches on, enhancing and speeding up the drying process. Sterilised instruments can safely be handled within
less than one minute after being removed from the cassette.
The hourly throughput of instruments of the STATIM is greater than
that of conventional benchtop autoclaves because of its rapid
cycle speed and five litre capacity.
Setting new standards
European Standard EN13060 defines and approves three
basic cycle classifications of small steam sterilisers.
Type of
cycle
Compare the results:
S
Solid
Unwrapped
Hollow
Unwrapped
Hollow
Unwrapped*
Hollow
Wrapped
Hollow
Wrapped*
Ruber/
Plastic
Ruber/
Plastic*
3.5 min./ 134°C
3.5 min./ 134°C
18 min./ 134°C
3.5 min./ 134°C
18 min./ 134°C
15 min./ 121°C
30 min./ 121°C
STATIM 2000S / G4
6:45
8:05
22:35
10:40
25:10
18:40
33:40
STATIM 5000S / G4
8:45
10:50
25:20
15:30
30:00
20:20
35:20
Total Cycle time w/o drying
Sterilisation time / temp
associated equipment is used only for the
sterilisation of the type of products for which
STATIM cassette autoclaves deliver dramatic improvements in process
efficiency through shorter cycle times.
Statim
“It is essential that the steriliser and
Description of approved use by EN13060
The sterilisation of products as specified by the manufacturers
of the steriliser including non wrapped solid products and at
least one of the following: porous products, small porous items,
hollow load products type A, hollow load products B, single
wrapped products, multiple-layer wrapped products
it is designed. The choice of steriliser,
sterilisation cycle or quality of services
provided can be inappropriate for a
particular load. Therefore the suitability of
the sterilisation procedure for a particular
N
The sterilisation of non wrapped solid products
B
The sterilisation of all wrapped or non-wrapped, solid, hollow
load products type A and porous products as represented
by the test loads in this standard
product needs to be verified by validation”
EN13060.
The STATIM cassette autoclave continues to meet
all EN13060 requirements.
Cycle time is dependent on instrument load.
* Choice of programme depends on the instrument manufacturer’s instructions and on the type of use (risk group).
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26793_SciCan_Opthamology_Layout 1 16/01/12 8:09 AM Page 5
The Certainty of Validation
The STATIM difference
Validation
Attractive, compact, reliable and gentle
The STATIM cassette autoclave is validated microbiologically by independent
research institutes and tested for specific instruments. These include many major
brands of ophthalmic handpieces and instruments and a number of them are
listed in the back of this brochure.
You can also monitor the STATIM sterilisation cycle on a daily basis with a
specifically designed Process Challenge Device (PCD) that makes STATIM an
autoclave that can prove its effectiveness by both biological and mechanical
means.
Monitoring
And with routine monitoring using SciCan’s ENSURE line of biological and
chemical indicators, you can be certain that STATIM is meeting the challenge of
ensuring that you, your staff, and your patients are protected against infection from
contaminated instruments.
The STATIM is small enough to fit onto a trolley inside the operating theatre. It generates little heat and virtually no noise.
The STATIM provides cycles for both wrapped & unwrapped solid and hollow instruments.
STATIM ’s steam injector system provides temperature consistency and expels the air that causes oxidation in conventional
autoclaves. The STATIM steriliser will only operate if clean, good quality, steam processed, distilled water is used and it uses
clean water every cycle, preventing the formation of rust and the build-up of bio contaminants. If the incorrect water is used, the
STATIM will not switch on and will display a warning. Independent research*3 shows that there are no detectable endotoxins in
the water reservoir of the STATIM. This further helps to reduce any potential problem with Diffuse Lamellar Keratitis (DLK).
In addition a 0.3µm biological filter ensures that the air entering STATIM ’s chamber for drying is biologically clean.
A compressor switches on immediately after the successful completion of any sterilising cycles, thereby reducing humidity
within the chamber with biologically clean dry air. Light, thin-walled STATIM cassettes promote rapid heating and cooling,
further minimising overall processing time and reducing instrument exposure to heat.
Data Collection
An undocumented sterilization cycle might as well not have been done. The
integrated printer on the STATIM 5000S can be used as a tracking device as it
provides detailed print-out records of all cycle data and parameters. The STATIM
5000S also has a 9-pin RS232 communication port that will allow the unit to be
connected to an external Data Logger that can collect cycle information and be
added to a USB stick.
Ultra-thin walled cassettes allow for
rapid heating and cooling
The STATIM G4 takes this one step further and features an integrated Data Logger
that stores all cycle information for the lifetime of the unit. A USB port allows for
the manual retrieval of cycle history. With an Ethernet connection, the STATIM G4
can be put in direct contact with your PC so this information can be viewed,
stored and printed whenever necessary. Additionally, the STATIM G4 has an
RS232 serial printer port that allows you to connect with an external printer for
record creation.
4
Precision inlet/outlet system for quick,
thorough steam injection and air purging
Schematic of forced air removal design
with combined purging
A microbiological filter prevents all
bacteria and spores larger than 0.3µm
from entering the chamber (cassette)
during the drying cycle
Easy to use
Drying
STATIM
Dri-TecC – Convection Heat Drying Technology
The STATIM 5000S is user friendly as a touch keypad and helpful LED display tells
the operator exactly what to do. STATIM is also self-diagnosing – if a problem
occurs at any stage during the sterilising cycle it will immediately be indicated on
the electronic display panel.
The STATIM 2000S & 2000 G4 use convection heat to dry instruments by
utilizing the remaining heat in the system after the sterilization phase. Heat is
captured and released into the cassette, drying wrapped instrument loads in
as little as 10 minutes.
STATIM G4
Dri-TecR – Radiant Heat Drying Technology
Following the same user friendly operation, the STATIM G4 high-resolution, 65K
color, 2.5” by 3” touchscreen offers a vivid display of messages, current cycle
information and customizable colours all with extraordinary clarity. Fully adjustable
contrast levels let you optimize the screen to the lighting in your steri-centre.
The STATIM 5000S & 5000 G4 use heat generated by the sterilization cycle
which is ‘absorbed’ by unique drying plates located in the sterilization
chamber. Heat is transferred from the drying plates directly to instruments
resulting in accelerated, full load drying in as little as 15 minutes.
5
26793_SciCan_Opthamology_Layout 1 16/01/12 8:09 AM Page 7
STATIM 2000S / 2000 G4
STATIM Specifications
Machine Dimensions:
The STATIM 2000S is a compact version of the STATIM 5000S.
It is the fastest and most effective sterilisation process available
in the world today. The STATIM 2000S autoclave is ideal for use
in the doctor’s consulting room because it takes just eight
minutes to complete a full cycle. It generates little heat, virtually
no noise and is small enough to be placed on a working surface
inside the consulting rooms and enables the economy of
sterilising instruments between patients. The STATIM 2000S
complies with the requirements of the latest standards for the
sterilisation of hollow or solid instruments whether or not these
are bagged prior to sterilisation.
Cassette Size (External):
(includes handles)
Cassette Size (Internal):
Length:
Width:
Height:
Length:
Width:
Height:
Length:
Width:
Height:
Weight (Without water):
Electrical Rating:
An optional but useful accessory for the STATIM 2000S,
the Statprinter helps to make record keeping easier and
the cycle print out can be used as a tracking device.
Validation and Standards
5000S
2000S
55 cm
48.5 cm
41.5 cm
41.5 cm
19 cm
15 cm
49.5 cm
41 cm
19.5 cm
19.5 cm
8 cm
4 cm
38 cm
28 cm
18 cm
18 cm
7.5 cm
3.5 cm
33 Kg
21 Kg
220 - 240 V, 50Hz, 6A
Accessories for STATIM
01-101613S
Cassette for STATIM 5000S
01-100008A
Cassette for STATIM 2000S
01-101649S
Cassette Seal for STATIM 5000S
01-100028S
Cassette Seal for STATIM 2000S
01-101657S
Thermal Paper (Box of 10 rolls)
01-108341
StatimHelix Test Device
99-108332
Sterilisation Helix Emulator 134˚C 3.5 min (250pcs)
Validated ophthalmic instruments
20ZPLUS
Stat-dri plus 8oz
Alcon NeoSonix Phaco handpiece
B&L Gillis irrigating-aspirating cannula
E4932
01-108263S
Instrument Basket for STATIM 5000S
Alcon
279R
B&L Gimble irrigating cannula
E4894
01-102119S
Biological Air Filter
Alcon
EJG
B&L Irrigating-aspirating handpiece
MVS 1063C
01-108341
PCD Final Assembly Kit
Chiron
6-pin
B&L Lasik cannula
E4989
01-112385S
Standard Cassette Tray with Mesh (5000 G4)
MedTec
9-pin
B&L Nichamin hydrossection cannula 26g
E4421 H
01-101709S
Mesh Rack
01-112510S
Cassette Tray (5000 Ext G4)
01-112509S
Cassette Complete (5000 Ext G4)
01-112384S
Cassette Complete (5000 G4)
01-112407S
Cassette Tray with Mesh Rack (2000 G4)
01-112406S
Cassette Complete (2000 G4)
01-112409S
Cassette Lid (2000 G4)
The above instruments were tested by third party testing agencies and passed the STATIM 2000S & 5000S’s ‘hollow
unwrapped’ cycle.
Standard
Reference
Medical Device Directive
Standards (European)
EN 13060
Small Steam Sterilisers
Standards (Safety, Europe)
EN 61010-1
Safety requirements Part 1: General requirements
EN 61010-2-040
Safety requirements Part 2-040: for steam autoclaves
EN 61326-1
EMC requirements
The STATIM complies with the requirements of international standards.
References:
1. James L Whitby, Chief of Department Microbiology and Immunology, University Hospital London, Canada. Research on the dental handpiece - the biological
indicators were killed at the start of the sterilising part of the cycle. All biological indicators were killed provided they had been subjected to a sterilisation cycle
of 90 seconds or greater.
2000 G4
49.5 cm
41.5 cm
15 cm
41 cm
19.5 cm
4 cm
28 cm
18 cm
3.5 cm
22 Kg
Order Code
Validated Phaco handpieces
Cooper Vision 9001
5000 G4
60 cm
41.5 cm
19 cm
49.5 cm
19.5 cm
8 cm
38 cm
18 cm
7.5 cm
34 Kg
Optional printer STATIM 5000 / 2000
Type:
Print:
Print Speed:
Paper Roll Capacity: approx.
01-108262S
Instrument Basket for STATIM 2000S
Thermal Printer
20 characters per line
1 line per second
80 sterilisation cycles per roll
2. Chris H Miller, Professor of Oral Microbiology, Indiana University. Research proving sterility of the Phaco handpiece in half a cycle. Copies available on request
3. James L Whitby, Chief of Department Microbiology and Immunology, University Hospital London, Canada and Victoria Hitchins, The Division of Life Sciences
Center of Devices and Radiological Health, USA Food & Drug Administration, Rockville. Research into Endotoxin Levels in Steam and Reservoirs of Table-top
Steam Sterilisers. J.Refract Surg 2002; 18: 51-57
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