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EN 285
TYPE TEST ISO 9001
ISO 13485
EN 17665-1 EN 285 CERTIFICATE ISO 14001
VALIDATION

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Dear Client,

We would like you to have the best efficiency of our product manufactured and tested with extreme care
in our modern facilities. Therefore we recommend you to read this manual completely and keep it as a
reference booklet.
Please call our service in case of any failure.
Please do not let any person who is not authorized by our company to interfere to the device, in order
not to cause more harm to your device which may affect its performance and electrical safety negatively.

Contact Information

İvedik Organize Sanayi Bölgesi

1453. Sok. No: 3, 06370 Ostim-Yenimahalle ANKARA / TÜRKİYE
Tel : +90.312.395 57 95 / Fax : +90.312.395 57 96
http://www.eryigit.com.tr/
[email protected]

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 Print History
All rights reserved. Except the cases permitted within the framework of copyrights, copying and modifying
this manual and/or translating it to another language is strictly prohibited without prior written permission.

Year of Printing : January 2015

Revision :5
Location : Ankara

The Manufacturer may change and update the information in this document without prior notice.

Warranty

ERYIGIT Medical Devices Inc. provides one year of warranty starting from the delivery date of the device you
purchased.

Declaration of Conformity

The Name of the Manufacturer : ERYIGIT Medical Devices Inc.

The Address of the Manufacturer : İvedik Organize Sanayi Bölgesi, 1453. Sok. No: 3, 06370
Ostim, ANKARA / TURKEY
Product Name : Steam Sterilizer

Model Name : GOLDBERG Series

We herewith declare that this product specified above conforms the covering directives of 93/42/EEC Medical
Devices and 97/23/EEC Pressure Equipment Directives and the standards given below.

Safety : TS EN 60601-1
EMC : TS EN 60601-1-2
LVD : TS EN 61010-2-040
Medical Device : TS EN 285
Pressure Device : EN 13445-1
EN 13445-2
EN 13445-3
EN 13445-4
EN 13445-5
Inst. Validation : TS EN ISO 17665-1

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Contents Page No

Section 1: Points to Mark 6-10

1.1. Recycling Information
1.2. Safety Information
1.3. Safety Issues Which Are Not Covered By Guarantee
1.4. Safety Specifications- Instructions on Loading Materials
1.5. Safety System Features of GOLDBERG Series Steam Sterilizers
1.6. General Safety Rules
Section 2: Control Systems and Their Specification in GOLDBERG Series Sterilizers 11-13
2.1. Device Control Systems and Programs Used
2.2. Sterilization Control System
2.3. Bowie-Dick
2.4. Printer
2.5. System Monitoring Program
2.6. Steam Quality Test
2.7. Electronic Test System (ETS)
2.8. Touch screen features
2.9. PLC System features
Section 3: Technical Specification Tables 14-16
3.1. Chamber dimensions
3.2. Device Dimensions – Single Sliding Door
3.3. Device Dimensions – Double Sliding Door
3.4. Device Dimensions – Single Flywheel Door
3.5. Device Dimensions Double Flywheel Door
3.6. Device Dimensions – Vertical Type
3.7. General Technical Info
3.8. Volume and Power Table of Sterilizer Models
3.9. Chamber
3.10. Generator
3.11. General Technical Information
3.12. Production types and door types
3.13. Chamber Material Layout Capacity
3.14. Height-Pressure Variation Graphic
Section 4: Instructions 17-22
4.1. Sterilizer Installation Instructions
4.2. Operating Instructions of the sterilizer
4.3. Operator Maintenance Instructions
4.4. Calibration Instructions
Section 5: Warranty Conditions 23-25
5.1. Warranty Conditions
5.2. Conditions Not Covered By Warranty
Section 6: Components and Descriptions of the Sterilizer 26-27
Section 7: Operation of Touchscreen 28-39
Maintenance and Repair 40-42
Circuit Diagrams 43-50
Mechanical Flow Diagram 51
Certificates 52-54

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Section 1: Points to Mark

1.1. Recycling Information

o Old devices are not useless garbage! Valuable raw materials may be gathered for reusing with an
environmentalist process of recycling.
o Remove the electricity connection of the old devices. Remove the feeder cable under control of an
authorized person.
o Your new device has been packed properly to avoid any damages during transportation. The package
of the new device is made of materials which do not harm the environment and can be recycled. You
can help protecting the environment by recycling the package.
o Don’t let children to play with the package or the parts of the package. They may be drown because of
the foldable carton and silver paper.
o Recycle the package. All materials used in packaging are non-polluting. Wooden parts are not
chemically processed.
o You can receive information on recycling procedures of old devices and packages and recycling
centers, from your dealer or the municipality.

1.2. Safety Information

o Before using the device read the “Usage and Assembling İnstructions” carefully. These instructions
include valuable information on installation, placement, usage and maintenance of the device.
o If you are going to give the device to another person or corporation, give this booklet to them as a
source of information.
o Manufacturer is not responsible for the results, which happened because of not reading or not
applying the instructions written below.
o Don’t run damaged of defective devices. If you are not sure, refer to your dealer or authorized
technical service.
o Installation, placement and the connection of the devices should be done under the assembling
instructions. Be sure that the connection values on electrical panel and type plate which device is
going to be connected are compatible with each other.
o The safety about the device’s electricity connection is satisfied if and only if institutes ground line is
done properly and under appropriate directives.
o In case of malfunction, maintenance and cleaning remove the electricity connections of the device. To
do this properly, turn down the paco switch at the network connection panel and close the fuses.
o Repairs on the electrified devices have to be done only by authorized experts.
o Be careful that dangerous situations may occur for the user if the repairs are not done properly or
done wrong.
o Do not close or choke the water and steam release holes
o Don’t let any unauthorized person to do anything to the device.

1.3. Safety Issues Which Are Not Covered By Guarantee

The external factors listed below may affect device working properly and repairs for these issues are
going to be billed.

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1. Devices operating voltage is 380 V AC ± 10 V and it cannot be operated with any other electrical
power. Damages due to this reason are subject to charge of payment.

2. Cretaceous Water: Water supplying the device should be appropriate to EN285 standard. Otherwise
the lime in the water may affect the resistance, vacuum motor, check valves, solenoid valves, the
water system, danfosses and other stainless parts and block the operation. Damages due to this
reason are not covered by guarantee and are subject to charge of payment.

3. According to the EN 285, the specifications of the water entering the device should be as below.
Otherwise damages due to water oriented issues will not be covered by guarantee and are subject to
charge of payment. Specifications of the water:

Determinant Feeding Water

Residue in Vaporization < 10 mg/L
Silicate (Si02) < 1 mg/L
Iron < 0,2 mg/L
Cadmium < 0,005 mg/L
Lead < 0,05 mg/L
Heavy metals other than iron, cadmium, lead < 0,1mg/L
Chloride (Cl) < 2 mg/L
Phosphate (P2O5) < 0,5 mg/L
Conductivity (25 °C) < 5 |j.S/cm
pH Value (Acidity Value) 5 - 7,5
View Free of sediment, clear, colorless
Asperity (Σ Earth Alkali Ions) < 0,02 mMol/L
Note – Conformation should be tested with known analytical methods

4. According to the EN 285 the specifications of the steam, entering the device should be:

Determinant Condensation
Silicate (Si02) < 0,1 mg/L
Iron < 0,1 mg/L
Cadmium < 0,005 mg/L
Lead < 0,05 mg/L
Heavy metals other than iron, cadmium, lead < 0,1mg/L
Chloride (CI') < 0,1 mg/L
Phosphate (P2O5) < 0,1 mg/L
Conductivity (25 °C’ta) < 3 |j.S/cm
pH Value (Acidity Value) 5 ila 7
View Free of sediment, clean,colorless
Asperity (Σ Earth Alkali Ions) < 0,02 mmol/L
Note – A method for taking condensation samples can be found in Section 22.4.

5. Narrow Outlay: The outlay of the device should be made of a heatproof metal pipe with minimum
diameter of 1”. Damages due to usage of not advised materials will not be covered by guarantee and
are subject to charge of payment.

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 6. Inadequate Water: Inadequate water delays or stops the sterilization and may cause failure. Damages
due to this issue will not be covered by guarantee and are subject to charge of payment.

7. Ambient temperature should be between +20 °C - +30 °C.

8. Humidity ratio should be between %30 - %50. Damages on sterilizers’ electronic and electrical parts
due to this issue will not be covered by guarantee and are subject to charge of payment.

1.4. Safety Specifications

Instructions on Loading Materials;

 Woven fabric materials and big packages should be loaded to lower shelf and small packages should be
loaded to upper shelf.

 Load in such a way that paper faces to paper and plastics faces plastic surfaces.

 Do not load the packages tightly.

 Place packs vertically and equipment containers horizontally to the lower shelf.

 If equipment containers are going to be placed horizontally to the sterilizer then you may place two
sets successively via using wire baskets.

 Release 5 – 10 cm space between the surface of the sterilizer and the packs. Also release space
between packs.

 The chamber volume should be loaded by considering its STU capacity. STU capacities are explained in
article 3.13 (1 STU = 30 x 30 x 60 cm).

 Place fabric sets as the ones concave inside placed side by side and slightly faced to downwards.

 Never place heat and humidity sensitive materials, Vaseline like greasy materials, liquids and power
tools inside the sterilizer for sterilizing.

1.5. Safety System Features of GOLDBERG Series Steam Sterilizers

 System gives warning operator when water runs out. When necessary system cuts the
power/electricity.

 System gives warning when the door left open and the cycle program does not start till the door get
closed.

 System gives warning when steam is not supplied and the program does not start till the steam is
provided.

 The door is not opened till the pressure in sterilization chamber reduces to atmospheric pressure.

 System gives warning with sound when line voltage drops down.

 System gives warning when in case of over pressure.

 Pressures sensors warn about the pressure errors.

 System gives warning in case of wire break-off and sensor failures.

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  Temperature sensing element shows (PT 100) failures on the display and informs the operator.

 Sterilizer chamber is tested under 3.8 bar working pressure and 6 bar testing pressure.

 System provides the evacuation of the steam securely in case that the over pressure occurs in the
sterilization chamber and the steam generator.

 System keeps the pressure inside the chamber under control as the door to be opened in any time
when the program does not run.

 System checks the door side seal with the pressure indicator.

 System has a door seal providing leak proofing during the chamber pressure reduces to atmospheric
pressure.

 System keeps the doors locked when the pressure difference between the chamber pressure and the
atmospheric pressure is ±100 milibar.

 System informs the difference between the chamber pressure and the atmospheric pressure through
the warning indicators.

 System has an emergency button to open doors.

 System does not allow to open the doors when the inner pressure is greater than 0,13 atmospheric
pressure and vacuum pressure is greater than 0,033 atmospheric pressure.

 Device has a pre-vacuum system. In vacuum phase, -0,8 (minus point eight) atmospheric pressure can
be achieved from 2 (two) atmospheric pressure in 3 (three) minutes maximum.

 Cycle programs runs if the temperature of the sterilization chamber reduces in acceptable ranges.
Printer can record both situations with their occurrence time.

1.6. General Safety Rules

Samples

WARNING: Used for the situations related with the health and life safety of the patient or the
operator.

CAUTION : Used for the dangerous situations related with the mounting and the material.

OPINION: Used for the general instructions related with the operation of the device.

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 The Rules

Steam Sterilizers of GOLDBERG Series can be stopped running by an emergency stop button in case
of any emergency. In emergency device evacuates the pressurized air in the chamber for safety
reasons.

Steam Sterilizers of GOLDBERG Series must be operated by qualified personnel and the operator
should be only person responsible for the device.

In case of any cancellation of the running program or an emergency stop, the material loaded for
sterilization must be re-prepared and sterilization must start from the beginning.

Nothing should be left or stored inside the sterilizer when it is not in use.

The materials after sterilization are hot, operator should wear gloves to prevent injuries during
unloading.

It should be well known by the operator to use which sterilization program for which material, if
not it should be asked to the manufacturer of the material.

When a new model of the device is manufactured; EN 285 standard Appendix F articles are exactly
applied to this new model.

Do not operate the device more than 8 (eight) hours in a day.

Wear gloves to unload the sterilized material out of the chamber.

Immediately clean the chamber in case of any liquid spilling inside of it.

Deionized water should not be used in order to get good result when measuring the water level.

Water conductivity must be 50 µS/cm in minimum.

Maximum flow and operation flow rate and max/min supply pressure for steam should be at least 3
bar/min.

All the details of like pressure, temperature and each phase or sub-phase ending can be printed out at
the end of sterilization together with time record of cycles.

Water consumption in a cycle can vary between 75 Lt-115 Lt.

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Section 2: Systems And Their Specification In GOLDBERG Series Sterilizers

2.1. Device Control Systems And Programs Used:

 Monitoring sterilization phases via PLC (Programmable Logistic Controller).

 Managing sterilization processes with the colored touch screen.
 Full control via control unit which passes electromagnetic compatibility tests.
 Microprocessor controlled main control system.
 Programs passed conformance test according to the EN 285 and EN 17665-1-2 standards.
Ready To Use Programs

 Bowie-Dick Test Program (Appropriate to EN285, 19.Chapter and 26.1-prEN867.3-clause 13.7.1.14-

26.1-8.3.2.1 conditions and standards.)
 Leak Test Program
 134°C Solid Materials
 134°C Textile Materials
 The option for special additional program capacity of 20 programs is available.

2.2. Sterilization Control System

 Network connection via Ethernet connection (TCP/IP) (optional)

 Ability to connect to central computer system or other computers or distance access via RS 232
output socket.
 User can access failure information, on screen or with sound.
 Parameter selected for program can be monitored on graphic display, changed and saved.
 All pressure measuring can be measured with electronic pressure transducer without using
presostat and pressure switch.
 Ability to continuously control the device’s safety components with PLC system.
 Ability to monitor the parameters during sterilization;
1. Which program is used
2. Step number and name of the sterilization phase
3. Pressure and heat values of chamber
4. Time of sterilization phase and name of failure in case a failure happens.
2.3. Bowie-Dick:

Non-homogenous parameters below are controlled with the color change test of the Bowie-Dick Test
paper, which is appropriate to EN 867-4 Standard:

 Deficiency of vacuum pumping function, air remaining at the device.

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  Existence of a potential leak at autoclave medium.

 Existence of overheated vapor or vapor containing driblets.

 Existence of non-condensate gases.
Bowie-Dick testing varies to the frequency of usage, unless the hospital has special conditions, and can
be performed once in a day or once in a week. Besides, this test should be performed for the cases
that the sterilization process is thought to be not appropriate.

2.4. Printer :

The parameters listed below can be monitored with a 40 columned alphanumeric printer with thermal
technology.

 Name of the Institution – Device Serial Number – Installation Number (if exists) – Date – Time
 Device Volume – Sequential Sterilization Number – Program Number
 Pre-vacuum time and phase number
 Pre-heating time and phase number
 Sterilization temperature – pressure – time
 Drying Temperature – Pressure – Time
 Failure messages that may happen in the system
 Total sterilization time
NOTE: Data cannot be stored for long time as the printer output is thermal paper. For this reason it
may be useful to take a photocopy of the thermal paper and keep it. Data should be stored for eleven
years according to EN 285 standard. Customer may request a dot-matrix printer to keep the data as
printed version. This is optional.

2.5. System Monitoring Program:

 Optional, “RS232 output socket” exists.

2.6. Steam Quality Test:

The parameters given below can be monitored during the run of GOLDBERG Sterilizers. These
parameters are monitored with respect to the relation between the pressure and the heat values.

 Wet steam
 Saturated steam
 Hot steam
 Over heating
Air leak test can also be monitored by a program in the device.

2.7. Electronic Test System (ETS):

The parameters controlled by ETS in sterilizers are given below:

 Whether the air left or not in the chamber,

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  Steam penetration,
 Leak test,
 Sterilization Parameter Indicators
 Interpretation for diagnostic purpose
 Early warning system
 Identification of the source of the problem
 Whether the overheated steam exists or not
 Calibration control
 Dilution Factor/Air Residue Calculating
 Engineering test (thermometric tests and air detection function test at small and full load)
 Data record storage and electronic calculation of death curve
2.8. Touch Screen Features:

 7” size, 65,000 color

 256 page, RS232 , RS422, USB Port and a printer port
 Simulation feature
 Fractional Monitoring of the processes
 Multi program (can be increased when required) and 20 Programs selection
 Multi program (can be increased when required) and 20 special program entering
 16,000 permanent memory and archive data
2.9. PLC System Features:

 10 Kb memory
 16 input adjustable socket connection
 16 output adjustable socket connection
 2 Analog input, 1 Analog output
 24 VDC Supply socket connection (Special Power Supply circuit to prevent influencing from
voltage variations)
 Real time and date
 Double port RS 232

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Section 3: Technical Specification Tables

3.1. Chamber dimensions of GOLDBEG Series

Chamber 160 Lt 250 Lt 300 Lt 422 Lt 550 Lt 675 Lt 840 Lt 75 Lt 75 Lt

Volume
Model GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG
160 250 300 422 550 675 840 75 75V
Diameter - - - - - - - 400 400
Height
(Mm) 400 500 500 670 670 750 750 - -
Width
(Mm) 400 500 500 670 670 750 750 - -
Depth
(Mm) 1000 1000 1200 1000 1250 1200 1500 600 600
(Mm)

3.2. Device Dimensions – Single Sliding Door

Model GOLDBERG 160 GOLDBERG 250 GOLDBERG 300 GOLDBERG 422 GOLDBERG 550 GOLDBERG 675 GOLDBERG 840

Width (mm) 800 900 900 1080 1080 1180 1180

Depth (mm) 1530 1630 1830 1630 1930 1780 2080
Height (mm) 1750 1850 1850 2000 2000 2100 2100

3.3 Device Dimensions – Double Sliding Door

Model GOLDBERG 160 GOLDBERG 250 GOLDBERG 300 GOLDBERG 422 GOLDBERG 550 GOLDBERG 675 GOLDBERG 840

Width (mm) - 1080 1080 1180 1180 1280 1280

Depth (mm) - 1375 1580 1375 1625 1580 1880
Height (mm) - 1850 1850 2000 2000 2100 2100
3.4. Device Dimensions – Single Flywheel Door

Model GOLDBERG 160 GOLDBERG 250 GOLDBERG 300 GOLDBERG 422 GOLDBERG 550 GOLDBERG 675 GOLDBERG 840

Width (mm) 780 880 880 990 990 1130 1130

Depth (mm) 1530 1630 1730 1630 1830 1730 1980
Height (mm) 1750 1850 1850 2000 2000 2050 2050

3.5. Device Dimensions Double Flywheel Door

Model GOLDBERG 160 GOLDBERG 250 GOLDBERG 300 GOLDBERG 422 GOLDBERG 550 GOLDBERG 675 GOLDBERG 840

Width (mm) - 1080 1080 1180 1180 1280 1280

Depth (mm) - 1240 1400 1240 1490 1450 1750
Height (mm) - 1850 1850 2000 2000 2050 2050

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3.6. Device Dimensions – Vertical Type

Model GOLDBERG 75 GOLDBERG 75V

Width (mm) 890 1050
Depth (mm) 600 620
Height (mm) 1210 1230

3.7. General Technical Info

Packed Medical and Surgical Instruments 134o C
Textile Materials 134o C
Bowie & Dick Test 134o C
Leak Test S
Additional (spare) Programs O
O: Optional S: Standard

3.8. Volume and Power Table of Sterilizer Models

Model GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG
160 250 300 422 550 675 840 160 250

Chamber
160 250 300 422 550 675 840 75 75
Volume (Lt)
Generator
Power ( 3 20KW 30 KW 30 KW 40 KW 40 KW 50 KW 60 KW 13 KW 13 KW
phase / 400
Power
±10 V AC) 30 KW 30 KW 40 KW 40 KW 50 KW 50 KW 60 KW 20 KW 20 KW
Requirement
Main
¾”Pipe ¾”Pipe 1”Pipe 1”Pipe 1”Pipe 1”Pipe 1”Pipe ½”Pipe ½”Pipe
Installation Values

Steam
4-6 Bar 4-6 Bar 4-6 Bar 4-6 Bar 4-6 Bar 4-6 Bar 4-6 Bar 3Bar 5 Bar
Supply
Air : 6-8 bar pressure, flow rate=100 Lt/d. 3/8’’ Pipe connection (for sliding door models)
Generator
60 Lt 60 Lt 60 Lt 60 Lt 70 Lt 70 Lt 70 Lt 16 Lt 16 Lt
Volume

3.9. Chamber - Test Results

Generator Water ½”Pipe ½”Pipe
2-4 Bar 30Lt/h 4 Bar 30 Lt/h
Chamber Test Pressure 7 Bar
Chamber Test Temperature 150 °C
Chamber Working Pressure 2,8 Bar
Chamber Working 140 °C
Temperature
3.10 Generator - Test Results

Generator Water ½”Pipe ½”Pipe 2-4

2-4Bar 40 Lt/h Bar 50 Lt/h
Generator Test Pressure 7 Bar
Generator Test Temperature 160 °C
Generator Working Pressure 3 Bar

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 Generator Working Temp 150°C

3.11. General Technical Information - Weight

GOLDBE GOLDBERG
Model GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG
160 250 300 422 550 675 840 RG 75 75V

Device (kg) 610 750 890 1050 1110 1310 1520 175 175

Device filled
680 820 960 1130 1190 1390 1600 195 195
with water
Packaged
(kg) 780 900 1070 1250 1290 1510 1720 225 240
Device (kg)

3.12. Production types and door types

GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBE GOLDBERG

Model
160 250 300 422 550 675 840 RG 75 75V
Chamber
160 Lt 250 Lt 300 Lt 422 Lt 550 Lt 675 Lt 840 Lt 75 Lt 75 Lt
Volume
Single Sliding
X X X X X X X
Door
Double Door X X X X X X
Single Flywheel
X X X X X X X X X
Door
Note: 75 liter flywheel door vertical type sterilizer is manufactured with vacuum or no vacuum option.

3.13. Chamber Material Layout Capacity

GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG GOLDBERG

Model 75 75V
160 250 300 422 550 675 840

Chamber
160 Lt 250 Lt 300 Lt 422 Lt 550 Lt 675 Lt 840 Lt 75 Lt 75 Lt
Volume
STU Capacity 2 4 5 8 10 12 15 - -

3.14. Height-Pressure Variation Graphic

Height

Atmosphere Pressure
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Section 4: Instructions

4.1. Sterilizer Installation Instructions (Installation Pre-Arrangements)

4.1.1. Water System Line & Drainage

a. The water entering to the device has to come through a softener.
b. Water’s asperity level must be determined and it has to be maximum 7 Frs.
c. Connections should not be accomplished unless the user is sure about the quality of the water.
d. If the water is supplied from hospital then the pressure must not be more than 3 bars.
e. There has to be clipper valve at the point of connection with the water.
f. The water system has to be in a position where it is isolated from the electrical system
g. The water system has to be well protected so that unauthorized person cannot step in.
h. Metal pipes have to be used for drainage.
i. Drainages connection part at the floor should not exceed 5 cm height.
j. The diameter of the pipes used in drainage must not be smaller than 1 inch.
k. There must not be sharp and low distanced turnings and narrowing’s in the drainage line.
l. Drainage’s exit’s distance to main disposal manhole should not be lower than 1.5 meters.
m. PVC based materials must not be used for drainage.

4.1.2. Electrical System & Panel

a. Installed capacity at the place where device is going to be installed has to be known.
b. The electric line entering to the panel must be single piece of cable. Cables added to each
other must not be used. Depending on the device model cables have to be 4x10 mm2, 4x16
mm2 or 4x25 mm2.
c. The ground line entering to the panel has to be done according to the necessary standards and
by authorized persons.
d. All switches and fuses used on the panel have to be high quality.
e. Panel should be distant from the water system or line.
f. Electricity supplying the panel has to be enough to provide 3 phase 380 V AC ±10 V power.
g. Depending on the electric power consumed by the device, there has to be used enough fuses
on the panel.
h. As our devices are designed and manufactured under IEC 60601-1-2 basis, they produce no
critical interference with the other devices.

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4.1.3. Space Requirements in General

a. Floor and walls have to be suitable for cleaning and preventing the dust and microbial
pollution.
b. Ceilings have to be constructed in order to minimize condensation, accumulation of dirt and
possible pollution sources. They must not allow adhesion and adsorption.
c. Air conditioning has to allow the polluted air formed in the place to move out from clean area
to polluted area at a speed of minimum 10 cycles per hour or has to allow it to be send outside
after filtering.

4.1.4. Ambient Temperature and Humidity

a. The temperature of the place where the device is going to be installed has to be between +20
°C - +30°C.
b. Air conditioning system has to be installed in order to stabilize the ambient temperature.
c. When the ambient temperature is absorbed from one line, cold air has to be given to the place
from another line.
d. Ambient humidity must be between 30% - 50%.

4.1.5. Compressed Air

a. There has to be a drying compressor to provide the compressed air for devices.
b. Compressor’s pumping up pressure has to be between 6 - 8 bars.
c. Compressed air should be also clean and involve no water or excessive humidity.
d. The connection between the air coming from the compressor and the device has to be
controlled.
4.1.6. Connection

a. Connect water to the device, prevent if there are any leaks and control the buoy.
b. Fix and tie the drainage and tighten up the hose bracelets.
c. Tie up the cables coming from the electric panel to the device panel tightly.
d. Your device is ready to operate.

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 HOSPITAL LAYOUT

Will be 1 ½ “ if
exceeds 12 m.

Cable length for sterilizers of 40 KW and over is max 8m (thickness 4X16 mm + ground line)
Cable length for sterilizers fewer than 40 KW is max 8m (thickness 4X10 mm + ground line).
1. Water supply line (PPr Pipe ½”),
2. Glob valve,
3. Water inlet ¾”,
4. Drain outlet 1 ¾”,
5. Nipple,
6. Sleeve coupling 1”,
7. Manhole (waste water drain-resistant to heat (160 oC) metal Pipe at least 1”)
8. Electric panel board (must be 80A contactor switch inside.)

NOTE: There must be at least 60 cm distance of space at the rear and side of the device, the distance between
the ceiling and top of the device should be at least 150 cm.

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4.2. Operating Instructions Of The Sterilizer

4.2.1. Preparation and controls

a. Before use please read “User & Service Manual”. In case of any error or failure check this
manual. If the failure still remains call service.
b. Check the device chamber whether it is empty, clean and the shelves are in place.
c. Check the electrical, water, drain and air connections are OK.
d. Check the water reservoir is full of water, keep input valve always open.
e. Check the air gauge indicates the enough level of air. (If air and water exist in the device then it
starts to get heated.)
f. In double sliding door types check the door on the clean side is closed.
g. Ensure that door gaskets are properly in place.
h. Be aware of that “EMERGENCY STOP” button is not pressed before the device is switched on.
4.2.2. Loading

a. Prepare the material to be sterilized. Load the material as to keep space of 5-10 cm from
chamber walls. Keep the 1/3 of chamber volume empty. (It is recommended to use loading
trolley and loading basket for loading).
b. Press on “EMERGENCY STOP” button in case of an emergency.
c. Open the valves on jacket, chamber and generator to evacuate the pressure in an emergency.
4.2.3. Running

a. Press on the “power” button in the front panel.

b. See the main menu on the screen.
c. See “No steam” message on the screen. “No water” and “no air” messages will disappear. If
not there is a failure and device will give error sound. Check the water and air supply.
d. Device will start to heat by resistances. When generator pressure manometer reaches to
approx. 3.2 bar (Green zone), air manometer reaches to 3 bar and jacket pressure to 2.8 bar
device will be ready and “no steam” message will disappear. Now the device is ready to use.
e. If the device is flywheel door type, close the door manually, if it is sliding door type, door will
be closed automatically.
4.2.4. Program Selection

a. “Ready” lamp will on.

b. Push the automatic use button on the touch screen.

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 c. Select the suitable program.
d. Use up-down arrows on select program section. (Ex: 134 °C Textile, 121 °C surgical
instruments)

4.2.5. Program Start

a. Press on the “START” button on the lower right corner of the screen and start the program.
b. Ensure that the door is closed. Then the device will run the selected program.

4.2.6. Program Stages

a. Check the program stages on the screen. See pre-vacuum, pre-heat, sterilization and drying
steps are running in sequence on the screen.
b. Monitor the graphical display and watch the sterilization steps.
c. In case of power cut during the sterilization a new menu will appear and ask whether to
resume the program. It is recommended to select “NO”.
d. Program will be completed automatically according the values selected by the operator. Then
“RECORD MENU” will appear with a sound warning. Record the values by pressing “RECORD”
button.
e. Take out the print out from the printer and see the sterilization is successfully completed. If
not repeat the sterilization.

4.2.7. Program End

a. Following the end of sterilization the door will automatically be opened if it is a sliding type. If
it is a flywheel type it will be opened by the operator manually following the end signal. Do not
apply force to open the door.
b. Watch the door opening on the clean side if your sterilizer is double sliding door type.
c. Never open the other door when one of the doors is opened.

4.2.8. Unloading

a. Sterilized materials are carefully unloaded by the operator.

b. Sterilization is successfully completed and the device is ready for the next sterilization process.
c. Switch off the device by pressing “POWER” button if a new sterilization will not be performed.

4.3. Operator Maintenance İnstructions

1. Never change or let it change the stabilization position of the device done by manufacturer
during the installation. Do not modify the installation position.
2. Unload the materials by using loading trolley after the sterilization.
3. Check any residues of textile particles in the chamber.
4. Clean the door gaskets once in a week with a recommended cleaning spray.

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 5. Do not touch the electrical and mechanical parts without the permission of authorized service
engineer.

6. Do not let the device move from its location during the general or specific cleaning of the
sterilization center.
7. Clean the surface of the device once in a week with a recommended maintenance spray.
8. Do not use hard materials that may cut or scratch during the maintenance.
9. Check the quality of the water and the air entering the device. Inform the qualified personnel
in case of any unwanted situation.
10. Empty and replace the water in the generator once in a month.
11. For a long term non-use disconnect the electrical and water connections.
12. Do not let the unqualified person to do maintenance.
13. Never put any material in the chamber other than the materials to be sterilized.
14. Never wipe inside the chamber with a material containing chemical composition.
15. Do not use liquids of flammable and oily nature during the maintenance.

4.4. Calibration Instructions

Sensor Specifications
1. Heat sensor : Thermocouple
Measuring range : 0-200 degree centigrade
Sensitivity : 0.01 degree centigrade.

2. Pressure sensor : Digital Manometer

Measuring range : -0.9 - 10 Bar
Sensitivity : 0.01 Bar

4.4.1. Temperature Calibration

a. Unscrew the coupling fitted for calibration.
b. Connect the temperature sensor (calibrated and specified above).
c. Specify the sample reference values for required temperature. (121 °C, 134 °C)
d. Press the 121 °C button on the manual control of the device.
e. Wait until the temperature indicator reaches to 121 °C.
f. When it reaches to 121 °C, note the value of the calibrated temperature sensor.
g. Note 5 separate values of the temperature indicator on the device and the calibrated
temperature sensor connected to the device, in one minute intervals.

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 h. If the temperature difference is out of the range of specified standards, adjust the
temperature sensor value on the touch screen.
i. Repeat the steps from 1 to 8 for the calibration of 134 °C.

4.4.2. Pressure Calibration

a. Unscrew the coupling fitted for calibration.
b. Connect the pressure sensor (calibrated and specified above).
c. Specify the sample reference values for required pressure. (-0.7 bar, 0.0 bar, 1.2 bar, 2.2 bar)
d. Press the 134 °C button on the manual control of the device.
e. Wait until the pressure indicator reaches to 2.2 bars.
f. When it reaches to 121 °C, note the value of the calibrated pressure sensor.
g. Note 5 separate values of the pressure indicator on the device and the calibrated pressure
sensor connected to the device, in one minute intervals.
h. If the pressure difference is out of the range of specified standards, adjust the pressure sensor
value on the touch screen.
i. Repeat the steps from 1 to 8 for the calibration of 1.2 bar, 0.0 bar, -0.7 bar by pressing the
related button on the screen.

Section 5: Warranty Conditions

5.1. Warranty Conditions

a. Product is under warranty along the period described in the warranty certificate against the
material, labor and manufacturer errors from the date of delivery on the invoice bill. The dates
on the Original Warranty Documents are obligatory for the signing parties.
b. Export products are under warranty of 1 year if otherwise specified. This period may be
extended with special agreements.
c. It is not allowed to do maintenance, service, parts replacement, etc. during the warranty
period by any person who is not authorized by ERYIGIT Medical Devices Inc. Device will be out
of warranty in case of any intervention and/or determination of any unauthorized action.
d. Any damage and failure occurred due to intervention of unauthorized person are not covered
by warranty. Labor is free of charge during the warranty period.
e. Repair time starts from the day after the date of written notice to the authorized dealer or to
ERYIGIT Medical Devices Inc. Excess time will be added to warranty period.
f. Scratches and fractures occurred on the outer body, plastic parts and PLC screen during the
loading, unloading and carrying after the delivery and damages or failures due to misuse are
not covered by warranty.
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g. Fire and stroke of lightning, low or excess line voltage, false installation and connection of
electricity, running the device under the voltage different from the specified value on the
product label are not covered by warranty.

h. Recovery of the failures occurred under the conditions of out of warranty are against
remuneration. Indemnification cannot be claimed for the situations out of warranty.
i. Failure notice in the country of Turkey will be replied back in the following 48 hours and the
device will be brought back to the running condition in 10 working days.
j. In case of a failure notice would be from a foreign country; as long as the visa procedures,
climate conditions, transport conditions and communication difficulty in a foreign languages
are figured out, device will be brought back to the running condition without abiding to a time
limit.
k. Identification of the failure and requirements will be carried out by technical staff of ERYIGIT
Medical Devices Inc.
l. Cases related to the repairing on site or on authorized services are subject to the approval of
the operator or the administration.
m. Payment is not claimed for the periodic maintenances specified in the agreements.
n. Eryigit Medical Devices Inc. will be intervener in case of written notice of the consumers about
the conflictions with authorized services who carry out the maintenance and repairing.
o. Device has 10 (ten) years of maintenance, repairing and spare parts warranty against
remuneration following the end of warranty period.
p. If the consumer demands, maintenance and repairing contract can be signed following the end
of warranty period.
q. ERYIGIT Medical Devices Inc. is not responsible from probable risks originated from the usage
of non-original spare parts on the devices manufactured by ERYIGIT Medical Devices Inc.
r. Conditions written in the “User Manual” supplied together with the device are also included to
the conditions out of warranty.
s. This warranty stands as long as the consumer or the institution as operator completely fulfills
the responsibilities on its side.
t. Warranty Certificate is prepared as two complete original copies. Any revisions on these
documents and on the label of the device indicating the serial number are not allowed.
u. Invoice bill of the material have to be kept all along the warranty period. Materials that are not
submitted with their invoice bill are dropped off the warranty provision.
v. The utilization of this certificate of warranty is under the permission of the Head Office of The
Prevention of Consumer Rights and Competition under the Industry and Trade Ministry of

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 Turkish Republic in accordance with the law numbered as 4077 and as per notification article
numbered as TRKGM-95/116-117.

5.2. Conditions Not Covered By Warranty

a. Damages and failures would occur due to not use of proper electrical connections and proper
voltage specified for the device by the manufacturer,
b. Damages and failures would occur due to improper connection of electrical installation,
improper location without flattening, improper mounting,
c. Damages and failures would occur due to necessary repairing of electrical system by
unauthorized service staff,
d. Damages and failures would occur due to running of the sterilizer by unqualified and untrained
staff,
e. Damages and failures would occur due to closing or causing to be clogged of water inlet and
steam outlet of the device,
f. Damages and failures would occur due to site modifications and repairing where the device is
installed, failures due to bursting plumbing..
g. Damages and failures would occur due to not removing the lime in the water or not softening
the water supplied to device,
h. Damages and failures would occur due to ambient temperature and moisture ratios not being
in the range of required values,
i. Damages and failures would occur due to shearing, piercing and scratching hardness of the
materials loaded to the device,
j. HEPA filters should be replaced in 3-6 months period with respect to atmospheric pollution of
the environment. HEPA filters are out of warranty and subject to a fee.
k. Solenoid valves are out of warranty and subject to a fee.
l. Check valves are out of warranty and subject to a fee.
m. Heating resistances are out of warranty and subject to a fee.
n. Door gaskets and center gaskets and cleaning sprays are out of warranty and subject to a fee.
o. Side panels covering sterilizer are out of warranty and subject to a fee.
p. Damages and failures due to intervention of unauthorized staff in foreign countries are out of
warranty.
q. Installation of software and software upgrade are subject to a fee.
r. Damages and failures due to fire and stroke of lightning, flood and inundation, low or excess
line voltage and acts of God specified by the law are out of warranty and subject to a fee.
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 s. Damages and failures due to loading, unloading and transport that are uncontrolled by Eryigit
Medical Devices Inc. inside or outside the countries of Turkey after the final acceptance are
out of warranty and subject to a fee.

Section 6: Components & Descriptions

6.1. Components and Descriptions of The Sterilizer

No Component Description

It is the framework of the sterilizer holding all the components of the

device. Side panels on it are easily removable so that it has easy access for
technical service. Device movement is easily provided by wheels connected
1 Chassis
to the frame and can be fixed by adjustable foots. Optionally manufactured
from AISI 304 grade stainless steel or carbon steel structural tube
(40X40mm) powdered by electrostatic dye (oven drying).

Sterilization Manufactured as rectangular prism or in cylindrical shape. Sterilization is

2 Room, performed inside it. Manufactured from AISI 316L or AISI 316 Ti grade
Chamber stainless steel. Chamber wall thickness is 6 mm.

3 Air Detector Operator is warned by air detector in case of any air leak in the chamber.

Provides heating chamber wall allowing the steam circulation on the outer

4 Steam Jacket surface of the chamber. Steam jacket and device door are manufactured
from AISI 304, AISI 316L or AISI 316 Ti grade stainless steel.

It is a separate unit where the steam is generated for sterilization

processes. Working pressure 3 bar manometer pressure. Produces steam

Steam with a saturation level at least 98 %. Heat is supplied by electrical

5
Generator resistances and water level is controlled by electrodes. It is manufactured
from AISI 316L or AISI 316Ti grade stainless steel. Tested in high pressures
electrical and mechanical safety is provided.
Electrical Used to produce saturated steam by heating the water in the steam
6 Resistance
generator. Manufactured from stainless steel, each one as 10 kWa.
(Heater)
Glass fiber is used as an isolation material in Autoclave chamber and

7 Isolation heating areas. Maximum heat radiated to the environment is tested as 45

°C (±3°C) thanks to the isolation.

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 Boiling of the water in the steam generator causes waves occurring on the
water surface and waves cause error in measuring the water level.
8 Water level box
Therefore water level is measured in water level box directly connected to
the steam generator.

Measure the water level in steam generator as low, high and safety levels.
Water level
9 Those probes provide the necessary volume of water and prevent to reduce
probes
water level under the resistance level.

Filters and cleans the air entering the device by Hepa Filters having 0.3
10 Filtration
micron porous 99,99 % bacterial filtering feature.

Chamber Removes the excess pressure when the chamber pressure reaches to the
11
Safety Valve critical level.
Jacket Safety Removes the excess pressure when the jacket pressure reaches to the
12
Valve critical level.
Pressure Sensitivity of calibrated pressure sensors is 1 % at 0.5 bar.
13
Sensors
Generator Removes the excess pressure when the generator pressure reaches to the
14
Safety Valve critical level.
15 Solenoid Valve Controls the movement (opening- closing) of the steam.
16 Water Used to supply the necessary water to device (Condense Tank)
Reservoir Measures the temperature in the chamber, jacket and in the generator,
PT100 (Heat
17
Sensor) enables the calibration of the device.
It is the entrance to be used for connection of PT100 to the device to do the
PT100 port for inspection of Authorized organization for the device calibration and
18 inspector
validation. There are two ½” independent pressure and temperature
organization
connection ports for the processes.
Used for the isolation of the door. Made of 100 % vulcanized silicon. Used in
19 Gasket
doors and in the center of flywheel doors.
It is the part that provides isolation of the chamber from outer atmosphere.
20 Door Flywheel or sliding types are available. Both door types provide the
isolation of chamber via vulcanized, heat resistant gaskets.
21 Control Panel It has 4-digit multi password feature and authorization is available.
Device has thermal or cartridge striped printer. Printer has automatic
22 Printer
winding mechanism. Printer is optional.
Internet It is possible to monitor failures, program loading and improving when the
23 Connection
necessary software loaded. There is optional RS232 connection.
Module

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 Device has stand-by feature and provides electricity and water saving about
24 Stand By
70-75 per cent.
Movement and Device has 4 wheels for easy movement. For stability, device has adjustable
25 Stability of the
rubber foots.
Device
Monitoring Monitoring Display is an LCD touch screen, temperature, time, date
26
Display pressure, and program stages are monitored.

Section 7: Operation of Touchscreen

Figure 1- Main Menu

 After the device is switched on, it is ready for sterilization and on the screen figure.1 will come up.

 By touching on “Menu” on screen figure.5 will be displayed.

 By touching on “Program” on screen figure.6 will be displayed.

When you press this button, the door will be open and figure.2 will be displayed.

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 Figure.2

When you press this button, the door will be close and figure.3 will be displayed.

Figure.3

If there is a problem at the sliding door, it will not work and figure.4 will be displayed on screen.

Figure 4

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 Figure.5

 Leak test: Leak test menu will come up.(Figure.5.1)

 Settings: You can change the settings of device.

 Reports: You can see the previous sterilization process and take a report about this process.

 System: You can see the working process with a visual data.

 Program set: It allows to the users to make their special program (It will request a password which will
be given by our company).

 Custom Programs: It allows using custom programs which was prepared by the user.

 Press button to reach previous menu.

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 Figure 1- Main Menu

When you press leak test, you will see figure.5.1on screen. Press “start” for the leak test.

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 Figure.5.1

After leak test starts, figure 5.2 will come up to the screen.

Figure.5.1.A

After the test ends, you will see the test result in the upper right corner. Press button to stop test.

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When you press “settings” on menu, figure.5.2 will comes up on the screen.

Figure.5.2

In this menu you can set up date, time, pre-heat timing and pre vacuum timing. Also user can turn on/off the
printer. When user touch the screen, a small keyboard will show up and user can change the settings from
this keyboard after enter the password. Red lock button is for technical service.

When you press the “reports” button on the screen, figure.5.3 will come up to the screen.

Figure.5.3

In the report page you can find older process information and take a report from printer.
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When you press “system monitoring” button, you can see the system visually. (Figure.5.4)

Figure.5.4.

When you press “program set”, figure.5.5 will come up to the screen.

Figure 5.5.

User can enter the password and set up the programs.

When you press “custom program” button, figure.5.6 will come up to the screen.

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 Figure.5.6

From this menu you can see the custom programs who was made by the user and start the system.

Figure.6

From the menu, user can choose the program which wants to use and start the process.

Programs

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 P1: Fabric
P2: Surgical Instrument
P3: Liquid
P4: Silicon
P5: Flash
P6: Prion
P7: Rubber
P8: Bowie-Dick,

If there is a problem with the system, figure.7 will come up to the screen.

Figure.7

Couple of seconds later a warning will show up on the screen about the problem. (Figure.8)

Figure.8

If there is pressure detected on the device, system will equalize the pressure.

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 Figure.9

Figure.10

f the user touch middle of the screen on this menu (figure.10), a screen will come up which shows the pressure
and temperature of the device momentarily. When user touches this screen again, the previous screen will
come up.

Figure.11

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If any problem occurs when the system works, a warning (figure.12) will come up on the screen. When this
warning comes up, user should cut off electrical supply of the device and call the technical service immediately.

Figure.12

In the sterilization process if the electricity cut off, process will stop and a warning (figure.13) will show up.
With the arrival of electricity, a warning will show up again (figure.14). After that user can choose to continue or
stop the sterilization process.

Figure.13
CAUTİON: If the system cannot provide the convenient conditions, even the user wants to continue the process
will stop.

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 Figure.14

In the sterilization process, to stop the system press button for an emergency situation . When you see the
figure.14 on the screen, select button to terminate the sterilization process.
When the sterilization process completes, figure.15 will show up. Press button
to record the data. To terminate the operation select button.

Figure.15

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Maintenance and Repair

Page 41 / 57
INFORMATION ABOUT SERVICE

1. Hygiene

 The hygiene of steam sterilizer devices are conducted following the producer company’s
recommendations.

 Inside of the chamber, basket’s rail, strainer, loading cart and the interior surface of the door are
cleaned by a damped cloth dipped into detergent warm water.

 A wet cloth without scrub cleans the plastic surface of the control panel.

 Rubbing polishes exterior surface of the device with a stainless polisher.

2. User Instruction for Sterilizer Maintenance

 Never change and let someone to change the stabilization - balance position that is made by the
producer company during maintenance. Do not change the place of installation.

 After the sterilization process, unload the sterile materials by loading cart.

 Control if there are textile particles that might be kept in the chamber.

 Clean the cover gaskets with the recommended spray once in a week.

 Without the permission of the technical service, do not ever custom the electric electronic and
mechanic components of the devices.

 Do not allow to displaced the device during the cleaning.

 The recommended stainless spray should clean the stainless exterior surface of the device once in a
week.

 During the maintenance, do not use materials having cutting and scraping features.

 Check the quality of the water and air coming to device. If you see an un-solicited status, please inform
the authorities.

 Drain and replace the water in the generator once in a month.

 Disconnect the electric and water connection if the device will not be used for a long time.

 Do not give permission to the personnel, who lack training and authority, for device maintenance.

 Do not ever put anything but the materials to be sterilized in the device.

 Do not ever clean inside of the chamber with materials of chemical compositions.

 During maintenance, do not use petroleum-based, inflammable, oily and shining liquids following any
environmental factor.

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3. Gasket change

After changing the gasket, spray gasket surface with gasket sprayer at least once a month.

Silikon
Conta

A-A

A-A

Gasket change

4. Resistance

When resistances are exposed to high temperatures, over time it can be calcification at the resistance.
Accordingly replace the resistances at least once every six months.

5. Sensors

9 GENERATOR PRESSURE SAFETY SWITCH

10 CHAMBER PRESSURE TRANSMITTER 1

11 CHAMBER PRESSURE TRANSMITTER 2

12 GENERATOR PRESSURE TRANSMITTER

13 JACKET PRESSURE TRANSMITTER

6. Electrode

Due to exposure high temperature, it may be calcification at the electrode.

Accordingly replace the electrodes at least once every six months.

Note: At the device, water tank has 1 and the generator has 3 water sensing electrodes.

If there is calcification in the water, please use “water softener device”.

CIRCUIT DIAGRAMS

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STEAM STERILIZER MECHANICAL FLOW DIAGRAM

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CERTIFICATES

MDD 93/42/EEC CERTIFICATE PED 97/23/EEC CERTIFICATE

ISO 9001:2008 CERTIFICATE

ISO 13485:2003 CERTIFICATE

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 ISO 14001:2004 CERTIFICATE EN 285 TYPE TEST CERTIFICATE

CERTIFICATE OF ACCREDITATION EN 285 VALIDATION TEST REPORT

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İvedik Organize Sanayi Bölgesi
Özanadolu Sanayi Sitesi 1453. Sok. No:3
Ostim, Yenimahalle – Ankara
Phone : +90.312.395 57 95
Fax : +90.312.395 57 96
E-mail : [email protected]
[email protected]
Web Page 57 / 57
: www.eryigit.com.tr