Azteca AC-470 Product Specification

Product Description
Azteca AC-470 is a fully automatic high-speed pre & post
vacuum steam sterilizer.
This model is an electrically heated sterilizer, which operates with
saturated steam as a sterilizing agent, and has a temperature
range of up to 137ºC (279ºF) and pressure up to 2.3 bars (34 psi).
The autoclave is classified as Class IIb according to MDD
93/42/EEC. The autoclave is designed as a Large Steam Sterilizer
in accordance with EN285 and as Class I in accordance with
EN60601-1, continuously operated, ordinary equipment without
applied parts and without signal input-output parts. The device is
not intended for use in the presence of flammable mixtures.

The sterilizer includes the following features:

 Large capacity sterilization chamber

 Built-in steam generator
 Vacuum pump for evacuation of the chamber
 Fully automatic door locking system
 Water reservoirs for process and used water retention
 Water pump for water circulation
 Condenser and collector for condensation and collection of
water Languages
 Temperature sensors and a pressure transducer to monitor
both vacuum and pressurized states The operator panel is set up with following standard languages
 Control valves operating at programmed intervals (maximum 20 languages per Sterilizer):

□ English □ German □ French □ Spanish

Application □ Czech □ Russian □ Hungarian □ Polish
□ Turkish □ Romanian □ Bulgarian □ Norwegian
The unit is designed to cover a large field of applications for
hospitals, medical centers and as secondary sterilizer for Standards
emergency cases at Operating Theatres. Azteca AC-470 sterilizer complies with following standards
and codes:
Dimensions  CE 0473 Approved by the British Notified body Intertek
– AMTAC.
Chamber: Inner Dia. x Depth: 400 x 750 mm  EN 285:2006 + A2:2009 – Large Steam Sterilizers.
Chamber volume, net.: 90 Litres. (1STU)  Medical Device Directive (MDD) 93/42/EEC.
External W x H x D: 750 x 630 x 970 mm  EN/IEC 61010-1:2001 – Safety of electrical equipment
– General Requirements.
Configuration and Options  EN 61010-2-040:05 Safety requirements for electrical
equipment for measurement, control and laboratory
Model Heating Doors use.
□ Azteca AC-470 □ Electric, 400V, AC □ Single  EN 61326:1997 + A1(98) + A2(01) (Directive
89/336/EEC) – (EMC) Electromagnetic compatibility.
Available Accessories  EN 61000-6-2; EN 61000-6-4 Electromagnetic
compatibility (EMC)-Generic standards- Emission and
Standard: Immunity for industrial environments.
 Pressure Equipment Directives (PED) 97/23/EC
□ Built-in Ink or Thermal Printer Essential safety requirements.
□ RS 232 Communication Port  ISO 17665-1:2006 – Sterilization of health care
□ One Stainless Steel Tray Holder with Two Trays products Moist heat Part: Requirements for the
development, validation and routine control of a
Optional: sterilization process for medical devices.
 Quality Management System Standards:
□ Reverse-Osmosis System  ISO 9001: 2008 – Quality Management Systems-
□ Air Detector Requirements.
□ SD Card & Reader  ISO 13485:2012 – Quality systems - Medical devices -
□ HMI PC Software Particular requirements for the application of ISO 9001.
□ SES 285 Sterilizer Evaluation System  EN ISO 14971 –Risk Management for Medical device.
□ Stainless Steel Cabinet
□ Internal Shelf for 1 STU
□ Sterilization Container/Basket

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Standard features
 Safety Devices - Numerous safety features including: a
• Microprocessor controlled steam sterilizer - Using steam
safety valve, thermostat, a temperature sensor, a water
under pressure as the sterilizing agent for wrapped or
detection electrode in the steam generator, pressure
unwrapped goods such as fabrics, surgical instruments,
sensors, a door locking device and software safety features.
utensils, and other heat and moisture stable materials at
temperatures from 121°C to 134°C. The Azteca AC-470
 Alarms – Depending on the state of the input and of the
sterilizer is a pre-and post-vacuum sterilizer designed to cover
installed accessories, the controller is capable of providing
a large field of applications for hospitals, medical centers and
an audio alarm, as well as displaying and/or printing several
as secondary sterilizer for emergency cases at Operating
alarms, including:
Theatres. Within the health care services, sterilization of
□ Door Unlock □ Temperature/Pressure Error □ Low/High
medical supplies is an essential issue in the battle against the
Temperature □ Low/High Pressure □ Low Vacuum
advance of many infectious diseases. In order to improve the
and more.
quality of sterile supply, international standards, which specify
the requirements for the equipment, and procedures in the
sterilization departments in health care facilities, have been  Door locking mechanism –The door system is automatic
developed. and based on a ring locking mechanism, driven by a geared
electric motor, preventing the opening of the door by a
• Design and Construction - The Azteca AC-470 sterilizer safety pin.
meets the highest standards requirements for quality, safety A lock ring grips the door and locks it securely.
and operation. Stainless steel pressure vessels 316 L To facilitate the locking process, a partial vacuum is created
conforms to the Pressure Equipment Directive (PED). The when closing the door which holds the door down while it is
inner shell, door(s) and jacket are designed for a maximum being closed, until the safety ring has mechanically locked
working pressure of 2.76 bar and full vacuum. The sterilizer’s the door. A locking device prevents the door from being
framework and housing are also made of stainless steel. The opened accidentally. The door lock can only be unlocked if
highly efficient, high-quality Hanno-Tech insulation material the unloading temperature has been reached and the
releases no particles; thus, the Azteca AC-470 sterilizer can sterilization chamber is in a depressurized state.
be used under clean room conditions.
 Water system – The sterilizers are equipped with 2 Water
Reservoirs: one for the tap water for the liquid ring vacuum
• Chamber- The vessel, with a coil jacketed round chamber, is pump and one for drain water. Water is circulated in the
made of corrosion-resistant electro-polished stainless steel water pump and converted to saturated steam.
316 L, and is thus easy to clean.
The Sterilizers are supplied as a stand-alone unit. A
• Exterior – Combination of stainless steel cover and plastic for Reverse-Osmosis water purification system is available in
front panel. order to avoid the need to refill the water reservoirs. This
system improves the quality of the water used to generate
• Steam generator – Equipped with a built-in 5.8 kW steam steam. The use of mineral-free water will contribute to better
generator, made of stainless steel 316 L. The large capacity performance and longer life of the Sterilizers’ chamber.
of the heaters enables steam to always be ready for  Energy saving mode - The Sterilizers are equipped with an
operation, and thus contributes to a very fast cycle. Energy Saving Mode which is activated when the unit is not
used after a certain period of time. This Mode reduces
• Vacuum system –Equipped with a Liquid ring vacuum pump, power consumption by approximately 12% to 30% and is
combined with a heat exchanger, and is a pre- and post-
vacuum sterilizer having the following features: thus environmental friendly.

An air removal stage (pre-vacuum), before starting the

sterilizing stage.
- A post-sterilization drying phase, based on the combined
operation of heat and vacuum with air inlet pulses.
In order to improve the efficiency of the vacuum pump –
capability and speed– a heat exchanger is installed on the
outlet piping of the chamber.
The advantages of the pre-vacuum sterilizer are as follows:
- Removal of air pockets from packs and porous load and
most kinds of hoses (rubber, plastic etc.) by vacuum at the
first stage of the cycle.
- Better steam penetration into the load; resulting in effective
sterilization.
Better temperature uniformity.
Better drying of materials due to the vacuum achieved in the
chamber at the end of the sterilization cycle.

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 Control system / Touch screen panel – A microprocessor Collected data can be downloaded into a computer
based control system, state of the art “Free scale” technology, equipped with proprietary PC Software. 2 Gigabyte SD card
automatically controls all programs including the sterilization collects up to 40 years logging data, including: the selected
cycle. The system includes a 5.7” digital touch-screen graphic cycle, start time, cycle stages, temperature / pressure, end
display, communication, self and remote diagnosis and PC time, cycle status (pass / fail), etc.
connection for external documentation and printing. It ensures An optional Ethernet Connection enables
a reliable, safe and user-friendly operation. The displayed controlling, monitoring and connecting your Azteca
information is available for users in a variety of languages. AC-470 with no need of additional software.
During the sterilization cycle the control system measures,
controls and shows in digital display: the time, chamber  Sterilizer Evaluation System (SES 285) – A totally
pressure and sterilization status. While the power is off, the independent monitoring and documenting system, the
non-volatile memory keeps the status of the Sterilizer, and the “SUPERVISOR”, compares the parameters recorded by the
real-time clock, driven by its own back-up battery, keeps basic automated sterilization process control system with
running the date and time. the parameters recorded by its own completely independent
sensor system. The “SUPERVISOR” performs a cross
checking of the timing/stages/cycles of the sterilization
according to the limits and tolerances defined in EN285, and
sends it to the user alarms in case the parameters are not
accepted.
The ‘SUPERVISOR” is connected
to a printer which registers all
parameters and provides
documentary proof of the
sterilization processes.

 Reverse Osmosis (water softener) – A Reverse Osmosis

system shall be used to improve the quality of the water
used to generate steam in the electric steam generator. The
use of mineral-free water will contribute to better
performance and longer life of the autoclave’s chamber. The
water purification system uses a high quality
booster pump which can provide 6.8 bar
water pressure to pass through the
 Operation – Operating is simple: close the door, select the membrane even under low water pressure
cycle on the Touch-Screen Panel, and press the Start Key. area. The booster pump prevents damage,
The cycle will run automatically. At the end of the cycle, by prolongs the life of the membrane and
pressing the ‘Open Door’ button on the Touch-Screen Panel, improves solids +99% of all organics +99%
the door will automatically open. of all bacteria.

 Cabinet – Stainless Steel Cabinet with

 Printer – The unit supplied with an storage space available upon request.
integrated ink printer or with thermal printer. Size: 755 x 785 x 785mm
Each cycle can be documented by the
printer which records the preset and actual
parameters of the cycle: the selected  Internal Shelf – The unit can be supplied
cycle, cycle parameters, date, time, with 1 internal shelf for 1 STU container
temperature, pressure, errors, etc. The last upon request. Size: 236 x 10 x 550mm
60 cycles’ data is automatically stored in
memory, and can be re-printed.
 Sterilization Containers / Baskets –
Aluminum sterilization containers
Options and Accessories and stainless steel wire baskets
are available in different sizes.
 Monitoring and Documentation Software
(HMI Software) – Powerful PC Windows
based software is available for monitoring,  Tray holder – Stainless steel tray holder for up to 4 trays (2
logging control and service. big and 2 small) is available. The unit standard supplied with
one tray holder and 2 trays
 Data collection – Sterilization cycles’ data (1 big and 1 small).
can be collected online trough standard
RS232 connection, enables connecting the  Stainless Steel Trays –
computer and the Sterilizer using the PC Stainless steel trays in 2 sizes.
Software (optional). Big tray: 320 x 20 x 580mm,
Small tray: 220 x 20 x 580mm
Sterilization cycles’ data can be also collected online on a SD
Card through an optional SD Card Slot.

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Cycle descriptions
Azteca AC-470 offers 7 different cycles: 5 sterilization cycles, and 2
test cycles. Additional cycles are available upon request. 4 - Prion 134°C /18 min, 20 min dry
The two available test programs are the Vacuum Test for checking Sterilizing wrapped instruments.
the integrity of the chamber and piping system and the Bowie & Load weight <18 kg. With drying stage.
Dick test which checks the efficiency of the sterilization process.

 Sterilization temperature: 134ºC, –0°C +3°C.

t1 = Conditioning  Sterilization time: 18 minutes.
t2 = Sterilization stage  Dry Time: 20 minutes.
t3 = Exhaust and dry  Vacuum pulses: 4.
stage
 Average cycle time: 55 minutes.

6– Porous 121°C /20 min, 20 min dry

Sterilizing of heat sensitive materials and
textiles.
Load weight <6 kg. With drying stage.

 Sterilization temperature: 121ºC, –0°C +3°C.

 Sterilization time: 20 minutes.
 Dry Time: 20 minutes.
 Vacuum pulses: 4.
1 - Flash 134°C /3 min (Warm Up).  Average cycle time: 55 minutes.

Sterilizing unwrapped instruments.

Load weight <18 kg. Without drying stage.

 Sterilization temperature: 134ºC, –0°C +3°C.

 Sterilization time: 3 minutes.
 Vacuum pulses: 4. 8 – Bowie and Dick test 134°C /3.5 min, 1 min
 Average cycle time: 20 minutes. dry (Hollow load A)

This is a test program, with fixed sterilization

2 - Unwrapped 134°C /3 min, 2 min dry parameters of 134°C and 3.5 min., drying time
(Dynamic sterilizer chamber pressure). of 1 min., which cannot be modified by the
operator.
Sterilizing unwrapped instruments.
Load weight <18 kg. With drying stage.  Sterilization temperature: 134ºC, –0°C +3°C.
 Sterilization time: 3.5 minutes.
 Dry Time: 1 minute.
 Sterilization temperature: 134ºC, –0°C +3°C.
 Vacuum pulses: 4.
 Sterilization time: 3 minutes.
 Average cycle time: 21 minutes.
 Dry Time: 2 minutes.
 Vacuum pulses: 4
 Average cycle time: 21 minutes.
9 – Leak test (Vacuum test)
3 - Wrapped 134°C /3.5 min, 15 min dry The vacuum pump is activated until the
pressure reaches a level of at least 15 kPa, all
Sterilizing wrapped instruments.
the valves and pump shut down. The following 5
Load weight <18 kg. With drying stage.
min. is for the stabilization condition of the
chamber.
 Sterilization temperature: 134ºC, –0°C +3°C. From now on along the next 10 min. the
 Sterilization time: 3.5 minutes. allowable decrease of pressure is 0.13 kPa /
 Dry Time: 15 minutes. min. (or 1.3 kPa for 10 min.)
 Vacuum pulses: 4.
 Average cycle time: 35 minutes.

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Technical Data Azteca AC-470

External dimensions W x H x D 750 x 630 x 970 mm (29.5 x 24.8 x 38.2 inch)
Maximum depth (door open) 1475 mm (58.1")
Chamber volume, net. 90 Litres.
Chamber shape Cylindrical 316L, welded, sand-blasted
Chamber Dimensions, Inner Dia. x Depth 400 x 750 mm
Weight 170 kg
Shipping weight 195 kg
Shipping dimensions W x H x D 820 x 880 x 1120 mm (32.3 x 34.6 x 44.1 inch)
Mineral free water reservoir volume With Reverse Osmosis system – External reservoir 8.3 Litres (2.2 gal)
Min. water quantity allowing the cycle 1 Litres
Average water consumption during the cycle 12 Litres (3.2 gal)
Max. Water temp. at the reservoirs 65ºC (149ºF)
Max. Working pressure 2.7 bar (39 psi)
Min. Working pressure -0.9 bar (-13.5 psi)
Heaters power 5800W + 900W (Silicone heater)
Jacket Electrical Silicone Heater
Peak sound level < 70 dB
Max electric power (to 230 V) 7 kW, 3 phase, 400V - 16A, 50/60 Hz
Voltage fluctuation ±10%
Operation Electronic with microprocessor
Controls Digital
Display 5.7˝ LCD Color Display, Resistive Touch Screen
Integrated printer Yes -(Standard)
Standard RS232, USB connection for service technicians and Ethernet connection
Connection to PC
as an option
No. of trays 2 (Standard – 1 Big and 1 Small) 2 more available upon request
Tray Holder dimensions W x H x D 363 x 230 x 430 mm (14.3 x 9.1 x 16.9 inch)
Big stainless steel tray (2 in total) (320 x 20 x 580mm) or Small stainless steel
Available trays optional
tray (2 in total) (220 x 20 x 580mm) or 1 internal shelf (236 x 10 x 550mm)
Maximum load for tray 4.5 kg (9.9 lb)
Maximum solid load 18 kg (39.6 lb)
Maximum textile load 6 kg (13.2 lb)

Number of Cycles 7 cycles - 5 sterilization cycles and 2 test cycles

Wrapped or non-wrapped, solid, hollow load products Type A and porous

Cycle type (stated load types)
products.
Sterilization temperatures 121-134°C
Special / Test Cycles Bowie & Dick test and Vacuum test

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Azteca AC-450 Product Specification

Technical Data Azteca AC-470

Air removal Fractionated vacuum
Drying system Vacuum
Total time: Flash134-(20 min) unwrapped +hollow134 (21 min) , prion, porous 134
Suggested Cycle time (minutes)
(55 min), wrapped 134-(35 min)
Stand-by Yes
Appearance of Face Painted quality steel and plastic
Automatic water filling Standard
Automatic water draining Standard

Door locking device Fully automatic, ring door locking device.

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