celitron operacion ingles.doc

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Integrated Sterilizer &

Shredder (ISS)

OPERATION MANUAL

QA090051 V1.10.1 Feb. 2011

Orig ina l instructions

of 84

TABLE OF CONTENTS

PARAGRAPH PAGE NO.

1. General …………………………………………………………. 4

1.1 Incoming Inspection …………………………………………….. 4

1.2 Warranty ………………………………..……………… .………….. 4

2. General Information .……………… …..………………………… 6

2.1 Introduction …………………………………………………….…… 6

2.2 B i o - H a z ar d S t er i l iz e r an d Shredder- explanation . .. ... .. ... .. ....

8

2.3 Operating Conditions ………………………………………….… . 9

2.4 Required Utilities . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .

9

2.5 Environment Emission Information ……………………… .….… . 10

2.6 Electromagnetic Compatibility (EMC) …………………….…. .. 10

2.7 Symbol Description ………………………………………………… 11

2.8 Specifications ……………………………………………………… . 11

2.9 Construction ……………………………………………… ………… 11

2.10 Water quality ...........………………………………………… ….. 12

2.11 Directives and Standards ………………………………….…… 14

2.12 Storage and Transportation ………………………………… .…… 14

2.13 Safety Devi ces ................………………… ………………….... 15

3. Cycles Descriptions ...................................................... . 16

3.1 Waste Sterilization . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .

16

3.2 Dynamic Test …………............. . ................ ............. ............ 17

3.3 Washing c y cle . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .

17

4. GUI (Graphic User Interface) description .……………… …... 18

4.1 Foreword …………………………………………………….…….... 18

4.2 GUI overview ………………………………………….… ................ 18

4.3 Main Screen . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... ..

18

4.4 On Process Screen ……………………… .….… ...................... 23

4.5 Keys on the Main Screen ………………………………………… 24

4.6 System Setup …………………….….......... ................ ............. 25

4.7 System messages …………………………………………………. 45

PARAGRAPH PAGE NO.

5.

5.1

Preparation before Sterilization

Waste Collection and Segregation

...................................... . 53

……………………………. 53

5.2 Loading . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... 55

5.3 Load discharge when process fa ils

. .. ... .. ... .. .... .. ... .. ... .. .... .. .57

5.4 Unloading …………………………………………………………. 57

6. Installation Instructions .................................................. . 58

6.1 Mounting . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. . 58

6.2 Piping . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. 60

6.3

6.4

6.5

Drain Connections

Power Connection

Protective Earthing

. .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... . 60

. .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... . 61

. .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. .. 61

6.6 Setting Atmospheric pressure parameter ……………………… 62

7. Operating Instructions .................................................... . 64

8. Maintenance Instructions ............................................... . 66

8.1 Preventive and Periodical Maintenance . .. ... .. ... .. .... .. ... .. ... .. .66

8.2 Maintenance task s to be carried out regula rly

. .. ... .. ... .. .... ..68

8.3 Emergency actions for Chamber under steam pressure . .. ... .. 68

8.4 Troubleshooting . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. ... 69

9. Valves Numbering ........................................................ . 74

10. Spare Parts list …………………………………………………….. 75

Appendixes ............................................................................. . 77

Drawings:

Electrical drawings . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... . 78

Piping schematic drawing . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. ....81

Pneumatic Drawing . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... . 83

EC Declaration of Conformity . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... ..

FIGURES: PAGE NO.

Fig. 1- Stand-by Screen …………………………………………………………………. 19

Fig. 2- Ready Status Screen ………………………………………………………….…. 20

Fig. 3- Error Screen ……………………………….………………..………………….…. 21

Fig. 4- Door Screen……………………………………………………………………….. 22

Fig. 5- On-process Screen ………………………………………………………………. 23

Fig. 6- Main Menu Screen ………………………….…………………………………… 25

Fig. 7- Set Clock Screen …………………………………………………….…………… 26

Fig. 8- Select Cycle Screen …………………..………………………………………... 27

Fig. 9- Language Screen ………………………………………………………………... 28

Fig. 10- Code Screen ………..………..…………………………………………………. 29

Fig. 11- Menu Screen……………………………………………………………….……. 30

Fig. 12- Parameters Screen……………………………………………………………… 31

Fig. 13- Set Parameters Screen………………………………………………………… 32

Fig. 14- Analog Inputs Screen………………………………………………….….…… 33

Fig. 15- Calibration Screen……………………………………………………………... 34

Fig. 16- Set Gain & Offset Screen………………………………………………….….. 35

Fig. 17- Calculate Gain & Offset Screen…………………………………………… 36

Fig. 18- Calculation of Gain & Offset by two points………………………….…. 38

Fig. 19- Analog Inputs Screen (same as fig. 14)……………………..….………. 39

Fig. 20- Digital Inputs/Outputs Screen………………………………………………… 40

Fig. 21- Contrast Screen………………………………………………………………… 41

Fig. 22- Process History Screen……………………………………………………….. 43

Fig. 23- The Tower Lamp…………..………………………………….....……………… 44

Fig. 24- Waste Segregation…………..………………………………………………… 53

Fig. 25- Load Position …………..………………………………………………….…… 56

Fig. 26- Unload Position …………..………………………….………………………… 56

Fig. 27- Working Position ...…………..………………………………………………… 56

Fig. 28- Utilities Connections on the rear side …………..………..……………… 58

Fig. 29- Recommendation for Room space for the ISS installation (top view) 59

Fig. 30- Power Connection……………………………………………………………… 61

Fig. 31- External Dimensions…………………………………………………………… 63

1. General

The device should be used as de scribed in this manual only.

The following are the Instruction before operating the device:

1.1 Incoming Inspection

Immediately upon reception of your product, examine the packaging

material and contents for shipment damage (such as: scratched panel

surfaces, broken knobs, etc). Report any such insta nce to yo ur dealer or

point of purchase.

All Celitron Medical Technologies Kft. prod ucts are tested and inspected

prior to shipment.

1.2 Warranty

Celitron Me dical Technologies Kft. warrants that the equipment has been

carefully te sted and inspected and has left the fact ory in prop er working

conditions, free of visible defects. Celitr on Medica l Technolo gies Kft.

warrants th e equipment to be free from defects in ma terial and

workmanship, under normal use and operation.

Note :

In case you meet some difficult ies and yo u do no t find the solution in

the manual:

Contact ou r represen tative.

Inform him with mode l and se rial number of the device

Describe the difficulty.

For ISS built with a printe r: send a copy of the last printout.

Reparation is accepted after ge tting authorization from the company.

Shipment (both ways): all costs are paid by the owner.

We accept this guaranty only if the unit is purchased from an authorized

full service dealer.

Note: The place of installation sha ll have a contractual connect ion to

a third party in char ge of handling hazardous substances in case of

leak ages fr om the machin e which cannot be handled by a

technician at short notice.

DO NOT SERVICE THE UNIT BY YOURSELF

Remarks:

The warranty does not include and does not replace routine

treatment and preventive maintenance.

Details of our Technical Service Department:

Celi tron Medical Technologi es Kft.

2600 Vác

Avar utca 5

Hungary

Phone: +36 27 512 267

Fax: +36 27 512 268

[email protected] m

mailto:[email protected]

mailto:[email protected]

2. General Information

2.1 Introduction

This device is a Steam Sterilizer with an integrated Shredder, intended fo r

treatment of Medical Waste in ho spitals and clinics.

The device shall not be used for disposal of Infectious chemical wastes

that requir e special treatment, or ganic materials, Blood and blood

products, unrecognizable human body parts and partials of organ s

remaining after surgery and other kind of medical treatment, laboratory

and pathology examination materials, and particles of those (unless local

country regulations allow it ).

This device's model is an electrically heated B i o - h a z a r d sterilizer, w h i

c h operates with satu rated steam as a sterilizin g agent, and has

a tempera ture range of up to 138 C (280 .4 ºF) and pressure up to 2.

4 bars (35 psi). The device is designed as a Large Steam Sterilizer in

accordance with EN285, continuously operated, ordinary equipment

without applied parts and without signal input-output parts. The device i s

not intended for use in the presence of flammable mixtures.

The device is constructed of st ainless steel and is heated by saturated

steam supplied by an external steam generator. All metal parts in

the

inner surfaces are made of stainless steel. The device's chamber is

equipped with one door, provided with an automatic lock ing mechanism,

activated by compressed air, preventing the openin g of the door by a

safety lock.

The ISS's op erating cy cles are us er-speci fied. Only on e general program is

available: Sterilization and shredding 138 ° C/ 10 Minutes, bottom (fast)

exhaust, 5 minutes drying. In addition, a Dynami c test program and a

washing cy cle are av ailable. The servic e cycles are prot ected by code

and may be operated by technical staff only:

- Sterilization and shredding 138°C/ 10 minutes without bottom (fast)

exhaust.

- Sterilization 138°C/ 10 minutes without shredding, and without bottom

exhaust (fas t).

The control system of the device is based on state of the art

microcomputer technology, ensuring a highly reliable and safe

operation. The computerized control unit ensures a fully automatic

operation through the entire cy cle; he nce after setting the pre-selected

data and st arting the operation, no further intervention is necessa ry.

The selected program, the main phases of the cycle and the status of the

machine are contr olled and displayed on digital readouts. For pr ocess

documentation, the important information concerning operatio n can be

printed in hard copy (optional).

For optimal contr ol accuracy of the sterilization param eters, the system is

equipped with temperature sensors PT100 and two pressure transducers

having the following functions:

A temperature sens or for chamber te mperature (contr ol and

printout).

A temperature sens or for the Filt er's te mperature (contr ol and

printout).

A temperature sensor for the Drain box's temperature (control and

monitoring).

A pressure transducer for chamber pr essure (control and printou t).

A pressure transducer fo r ge nerator pressure (control of the

generator and monito ring).

A pressure transducer in the over-pressurized sealing area fo r the

knife shaft (safety and monitoring).

The panel located on the fron t panel en ables the operator to start and

stop the cy cle.

The ma chine is intended to be used by a pers on with know ledge an d

experien ce in the use of the machi ne, according to the user manual

and training.

The machine is intended to be operated by the operator in an upri ght

stan ding positi on. The operator starts th e machine after putting the

waste into the vessel.

The machine is intended to be maintained by a skil led/qu alified

technici an following the instructions gi ven in the technician

manual and training.

Only technical personnel havi ng proper qualifications and holding

technical documentation (inclu ding a technician manual) an d

adequate information are au thorized to service the device .

Only authorized pers onnel should have access to select th e program

and ch ange the major parameters by usin g th e key.

2.2 Bio-Hazard Sterilizer and Shredder- explanation

The ISS processes Regulated Medical Waste into ordinary Municipal Solid

Waste. This means that the resultant steril e output can be safely disposed

as regular waste.

The violent action of the shredding blades allows st eam to penetrate the

waste more efficiently and eliminates the possibility of cold spots.

The resultan t waste is unrecognizable and reduced by 50-80%.

Post processing, the tr eated waste is suitab le for regular disposal.

A short explanation of the process (see piping diagram at annex 1): afte r

loading the chamber, the door automatically closes and the chamber

rotates to working position (fully vertical).

At this stag e, 1 vacuum pulse of up to 35kPa is implemented through

valve no. 9, through the Bio filter. Afte r vacuum is created, steam is

introduced through a lower steam filter (valve no. 3), until sterilization

temperatur e is achieved. Th e shredder blades start rotating from the

moment of cycle starting.

During the inflation of the cham ber with steam, the Bio filter valve (6) is

opened, until the steam is replacing the air completely. This valve

releases air through the Bio-filter to the drain box.

The drain box includes a float switch and a temperature sensor, to verify

that no blockage ha s occurred , and to control the temperature of wate r

going to the drain. In case of blockage, the exhaust will be stopped and a

failure indication will be provided.

During sterilizat ion, the bio filter functions as an integral part of the

chamber (b eing sterilized).

Compressed air is introduced through va lve no. 4 (Clean fi lter) to clean

the fi lt er.

The shredder's Blades:

The vessel is equipped with a multipurpose shredder/crusher blade on the

bottom, to ensure use of the full volume of the vessel. It is regulated by

an electric motor wh ich drives the knife shaft through a tooth belt. The

shaft connects the knife to the motor through the bearing housing and

the sealing area. The motor is of 5.5kW and is sufficient to rota te the shaft

with an RPM of 300- 1400 for v a rious operations. The blades are mounted

on the shaft and are designed in a way that it shreds waste such as

paper, small textile, plastic and glass. The blade is made of h igh carbon

steel with hardened cutting edges.

2.3 Operating Conditions

This device is for indoor use only!

The device should be loaded only with autoclavable material! See

paragraph 5.1, Waste Collection an d Segregation, for more details

on allowed materials.

The environment shall not exceed an ambient temp erature of 40ºC

and a relative humidit y of 85% respectively.

The operation altitude shall no t be over 2000 meters (ambient

pressure shall not be lower than 80 kPa (11.6 psi)).

Caution!

Waste water should be brough t into the public net in accordance

with th e lo cal rules or requirements . Only non-hazardous liquids

shall be disposed in public sewage!

2.4 Required Utilities

Electrical: 400V 3-ph, 16 or 25 kW

Optional- External Steam: 30 KG /hr. at 6 bar

Water: 30 l/ min. cold water, ½" connection

Drain: 2"-4"

Compressed Air: 6 ba r

HVAC: St andard computer environment, 10 air exchanges/hour in

room, machine co nnection to outside vent.

2.5 Environment Emission Information

The peak sound leve l generated by the device is less than 90

db A with background noise of 80 db A.

The total heat per hour transmitted by the device is < 100 Wh.

The device is not a source of electromagnetic emissions for

medical purposes. Th e level of the EMC Emissions was tested by a

certified laboratory according to the list of relevant standards (see

clause 2.10), and found to be in compliance with the

requirements.

Note:

The nois e level of the machine has been meas ured and found in

compliance with stan dards. However, the noise level also

depends on envi ronmental fa ctors (such as echo, acou stics ) . T

o avoid damage to the operators, after installation, it is

recommended to check the noise level acco rding to local

regulati ons. In case the noise appear s too high, use protective

measurements such as ear covers.

2.6 Electromagnetic Compatibility (EMC)

The installa tion and the service of the device sh ould consider special

precautions regarding EMC according to the information accompanying

in this user and service manual.

Warning - The use of cables, pumps, transducers or any other

electrical elements other than those spec ified by Celitr on Medical

Technologies as replacement parts may result in increased

EMMISIONS or decr eased IMMUNI TY of the device.

Warning - the device should no t be used adjacent to or stacked

with other equipments.

Warning -the device should no t be connected to th e same power

line with other equipments.

Warning -Portable and mobile RF co mmunications equipment such

as cellular phones can affect the oper ation of the device.

2.7 Symbol Description

This sign indicates the need of caution. Read accurately

all the notes beside this sign.

This sign informs about hot surface.

This sign po ints to the Grounding connection

This sign po ints Danger of High Voltage.

2.8 Specifications

MOD E L ISS AC -5 50 ISS AC -575 Chamber size (mm)

Diam D

500 600

500 800

Chamber volume (Ltr) 110 160 Weight (Kg) 500 600 External Dimensions (W xHxD) 130x20 0x1 9 4 cm Chamber Door 1 A ut omat i c Doo rSter i lizat ion Temper at u r e 121 ° C - 140 °C Steam Source Saturated St eam Steam Pr essure 2.5 - 3.5 BA RTest Pr essure 5.0 B A RCom p re sse d Air 5.0 - 7.0 B A RWater Source Pressure

Filtered Tap Wate r1.0 - 6.0 BA R

Power So urce 3-Ph.4 0 0 V, 50 /6 0 Hz Kw in clu ding St eam Gen e r at o r 16Kw 25Kw

2.9 Construction

The main parts of the device are made of materials as indicated below:

Chamber is built of stainless steel AISI 316L thickness 4mm.

Door is made of stainless steel AISI 304.

2.10 Water Quality

The Mineral- free wate r supplied to the steam generator should have the

physical characteristics and maximum acceptable level of co ntaminants

indicated in the table below:

Maximum values of contaminants in Feed water and Condensate in accordance wi th Standard EN 285

Contaminant Feed water Condensate

Evaporation residue ≤ 10 mg /l -

Silicium oxide, SiO2 ≤ 1 mg/l ≤ 0.1 mg / kg

Iron ≤ 0.2 mg/l ≤ 0.1 mg / kg

Cadmium ≤ 0.005 mg/l ≤ 0.005 mg/kg

Lead ≤ 0.05 mg/l ≤ 0.05 mg / kg

Rest of heavy metals except Iron, Cadmium, Lead ≤ 0.1 mg/l ≤ 0.1 mg / kg

Chloride (Cl) ≤ 2 mg/l ≤ 0.1 mg / kg

Phosphate(P2 O5 ) ≤ 0.5 mg/l ≤ 0.1 mg / kg

Conductivity (at 25°C) ≤ 5 ms /cm ≤ 3 ms /cm

pH value 5 to 7 5 to 7

Hardness ≤ 0.02 mmol/l ≤ 0.02 mmol/l

Appearancecolorless clean withoutsediment

colorless clean withoutsediment

Compliance with the above data should be tested in accordance with

acknowledg ed analytical methods, by an authorized laboratory.

Attention:

The use of water for Sterilizers that does not comply wi th the table

above may have severe impact on the workin g life of th e sterilizer and

can in validate th e manufactu rer’s guar antee.

The aforem entioned requirements conce rning the water supp ly are also

valid for st eam supplied from boilers installed at the customer’s site ,

which enter the sterilizer chamber and co me in contact with the produc

ts or packaging.

2.10.1 R e v e rs e Os m o si s

A Reverse Osmosis system is highly reco mmended for use to im prove the

quality of the water used to ge nerate steam into the device's chamber.

The use of mineral-free water will contribute to better performance and

longer life of the device.

2.10.2 Water for th e cleaning System and th e Drain Cooling

The feed water supp lied to the liquid ring ejector must meet the followin g

requirements:

Hardness: 0.7 - 2 mm ol/l, 4-12 °(German) of CaCO 3 ,

7. 2-21°(F rench) of C a C O 3 , 72- 215 mg/l of CaCO 3

The use of soft water is stri ctly forbidden!

Note:

The use of heavy scaled water for th e cleaning and cooling, can cause

blocking of the valves/pipes and pu t the elements out of operation.

This invalidates the guaran tee for the device.

2.11 Directives and Standards

Technical Standards

Pressure Eq uipment Directive 97 /23/EC (PED)

Machinery Directive 2006/42/EC.

EN 60204-1:2006+ A1:2009 Safety of machinery- Electrical

equipment of machines- Part 1: General requirements .

EN 61000 -6-2 Electromagnetic compatibility (EMC)- Generi c

standards- Immunity for industria l environm ents.

EN 61000 -6-4 Electromagnetic compatibility (EMC)- Generi c

standards- Emission st andard for industrial environments.

EN 285:2006– Large Steam Sterilizers.

ISO 17665- 1 (200 6)- S t erilization of health care products Moist heat

Part 1: Requirements for the development, valida tion and routine

control of a sterilizat io n process for medica l devices .

ISO 12100-1, ISO 12100-2- Safety of machinery - Basic concepts,

general pr inciples for design.

ISO 14121-1, ISO/TR 14121-2- Safety of machinery - Risk assessment

Quality standards

The compa ny's quality management system meets the following quality

standards:

ISO 9001:2008– Quality Management System- Requirements.

2.12 Storage and Transportation Conditions

The storage environm ent ambient temperature should be in the

range of 0- 50ºC and a relative humidity of 90% respectively.

The storage and transportation altitude shall not be over 2400

meters (ambient pressure shall not be lower than 76 kPa (

11.02 psi)).

The atmospheric pressure range should be of 700 – 1060 hPa

diapason.

Equipment may be moved only with empty Water Reservoirs.

The device shall be transported packed in wooden boxes, upon

wooden pallets. The boxes' dimensions are approximately

50x230x23 0 cm and 120x190x1 90 cm, in an upright position!

2.13 Safety Devices

Approved Thermostats-

These safety components interrupt the heating element in case of the

temperature above 150ºC f o r chamber and 170ºC f o r steam

generator. In order to precede the work, the user needs to push the

reset button.

Pressostat-

This safety component interrupts the he ating elem ent in the steam

generator in case of the pressure above 3.3 BAR.

Certified Safety Valves-

This safety component releases the pressures above 2.76 BAR

(Chamber) and 3.5 BAR (Steam Generator).

Safety switches:

1 Exte rnal Emergency stop switch, connected to a 3-ph conta ctor;

1 Internal Emergency stop switch, connected to a 3-ph conta ctor;

1 Main Door Safe ty Sw itch.

Motor Frequency Cont rollers-

This controller includes an overlo ad detect or and dis-connect or .

3. Cycles Descriptions

The device offers 1 sterilization cycle, 1 test cycle and 1 cleaning cycle.

3.1 W aste Sterilization

Sterilization temperature: 138ºC (273ºF), –0°C +3°C, (–0°F +5.4°F)

Sterilization time: 10 minutes.

Dry Time: 5 minutes.

Vacuum pulses: 1.

Average cycle time: 25 minutes.

Cycle Sequence

L o a d i n g : waste is loaded into the chamber. The door closes and the

chamber rotates to the process position (fully vertical).

Sh re ddi n g : The shredder starts working with the start of the cycle in different

speeds, as required. The shredder continues working in high speed for 2

minutes. After this time elapses, the shredder stops working.

St e r i li z a t i o n s t age : The cycle starts with one vacuum pulse to 35kPa, to

remove the air from the chamber. He a t ing Stage : Steam is introduced into

the chamber until the sterilization temperature is reached (138°C and

pressure of 312kPa); temperature and pressure are controlled at the

required sterilization level for the sterilization time. The Bio Filter valve

is working in shoot mode of 3 seconds opened and 30 seconds closed

throughout the sterilization stage.

Exhaust stage : the shredder starts working in low speed. The Top exhaust

valve opens to reduce pressure via a bio-hazard filter down to 150kPa

(Exhaust Press parameter). When pressure is lower than 150 kPa, the Fast

Exhaust valve opens.

D r ain : Liquids and steam are rapidly exhausted from the chamber to the

drain box, until pressure equalizes atmospheric pressure. The shredder's

blades are working.

D r yi n g s t age : vacuum is created in the chamber for 5 min. During the drying

stage, the Bio-Filter out valve works in shoot mode of 2 seconds On and 45

seconds Off, atmospheric pressure is achieved in the chamber by

controlling the Compressed air to chamber and the top Exhaust valves via

the bio-hazard filter, until the end of the cycle.

Unloadin g : the chamber rotates to the unloading position and the waste is

evacuated to the bin.

Note: it is important to implement the following test (Dynamic test)

at least once every working week, to detect leaks which may cause

infection to the operator and the environment!

3.2 Dynamic test

The purpose of this test is to detect leakages under pressure.

Operations Sequence

Water and steam are introduced into the EMPTY chamber at 138°C

for a preset pressure (2.4 bar), for 5 min.

The shredder is operated to create a vortex.

During periodic Maintenance, or if a leak has been detected during

this test, a technician may use leak detection foam to detect the

source of leakages during this test.

3.3 Cleaning cycle

Operations Sequence

Water and steam are introduced into the EMPTY chamber for 5 min;

steam is introduced to the filter to clean any remaining residues.

The system holds a temperature of 60°C in the chamber for 2

minutes, while the shredder is working in high speed.

Pressurizing the chamber to 150 kPa with steam and compressed air.

Drainage of the water and residue into the drain box via the Fast

Exhaust valve.

Adding Water for 2 minutes. The shredder's motor is stopped.

Pressurizing the chamber to 110 kPa with steam and compressed air.

Drainage of the water into the drain box via the Fast Exhaust valve.

4. GUI (Graphic User Interface) description

4.1 Foreword

The intent of this section is to provide in formation about the SCS2-285

control syst em's Graphic User Inte rface. This paragraph will:

Provide a general overview of th e GUI.

Explain how to operate the control system and how to perform all

available actions using GUI.

List all existing textual and graphic messages and in dicators which

the system provides.

4.2 GUI Overview

4.2.1 The LCD display

The GUI of the SCS2-285 control system is based on LCD Display with color

range: RGB 18 bit, Resolution: 320xRGBx240 pixels.

4.2.2 Touch Panel

The GUI has a Touch panel used for user input.

4.2.3 GUI structure

The GUI is based on screens. A Screen is what is displayed on the LCD in a

given time. A Screen presents useful information such as temperature,

textual messages, icons etc. A Screen also contains required keys. Based on

the system process, the screens will be changed. In this case the GUI will

display required information and will allow required input from the user.

4.3 Main Screens

The Main screens enable basic User-Machine interaction. The main screens

display the data when the device is on standby mode and displays different

data when the system performs sterilization process. 3 types of main screens

are available:

4.3.1 Stand-by Screen

This screen is automatically displayed after the system is started. This screen

is used to display useful information when the system is on Stand-by: Ready

status of the machine, Errors, Failures and other messages are displayed.

The Main screen enables setup of the system: selecting a program,

parameter setup and many other operations that will be described later in

this paragraph.

ChamberPressure

ChamberTemperature

Clock

LoadNumber

Message

SelectedCycle

Fig. 1- Stand-by Screen

4.3.1.1 Displayed data on Stand-By screen

Selected Cycle- the device is designed to run several different cycles. It

represents the current selected cycle. This field includes the textual cycle

name and the cycle symbol.

Message – In this line the user will get informative messages, faults, results

and instructions.

Clock – Current time of the control system.

Chamber Pressure – Current chamber pressure, the unit ( k P a , P S I , e t c. )

will be shown too.

Load Number – the total cycle's counter. With every cycle this value will be

increased by one. The counter is used to determine the maintenance status

of the device.

4.3.1.2 Ready Stat us

Fig. 2- Ready Status Screen

If the machine is not ready to perform a sterilization process, the reason will

be displayed on Stand-by screen. In this case, the ‘START’ key is

unavailable. If the device is ready to perform a sterilization cycle, “Ready”

message is displayed and ‘START’ key is visible.

4.3.1.3 Error/Failure

Fig. 3- Error Screen

If an error occurs, or a sterilization process fails, the reason will be displayed.

The system will not respond until the ‘CLEAR’ key will be pressed.

4.3.1.4 Door Operation

a. On the main screen press the Door key. This will display the

‘DOOR’ screen:

Fig. 4- Door Screen

b. Touch the required field in order to rotate the chamber to the correct

position.

LOAD- will open the door while the chamber is in Load position.

UNOAD- will rotate the chamber to Unloading position.

CLOSE- will rotate the chamber to Working position and close the door in

order to start a cycle.

STOP- will stop the process.

4.4 On-Process Screen

This screen is displayed when the device is performing the sterilization

process. All relevant data during the process is displayed on this screen.

ProcessStatus

ChamberTemperature

ProcessGraph

ChamberPressure

SelectedCycle

Fig. 5- On-process Screen

4.4.1 Displayed data on Process screen

Process Status – A textual indicator which describes the sterilization process.

Process Graph – Process progress. The graph displays Chamber Pressure as

a function of time.

Process Timer – Time since the process had started.

Chamber Temperature - Current chamber temperature in °C.

Chamber Pressure - Current chamber pressure in kPa.

4.5 Keys on the main screens

Select Cycle

Pressing this key will display ‘Select Cycle’ screen, which enables changing

current cycle. This key is enabled only when the device is on standby.

Start New Cycle

Pressing this key will start the selected cycle. This key is available when the

device is ready to perform a new process.

Open Door

This key is available on standby, when inside conditions (pressure and

temperature) are not dangerous. Pressing this key will open the chamber

door.

Reset Error

This key is displayed when the device is on standby and an Error/Failure

occurs. Pressing this key will reset the error and will return the device to

normal mode. (In some cases, pressing this button will display ‘ENTER CODE’

screen, if the error reset is allowed to authorized people only).

Menu Key

Pressing this key will show the ‘MENU’ screen. It enables setup of the system.

4.6 System Setup

Pressing the key on the main screen, will show the ‘MENU’ screen:

Fig. 6- Main Menu Screen

Select the required setup action by pressing the icons shown on the screen.

Pressing the ‘EXIT’ key will go back to the main screen.

4.6.1 Setting the system's clock

The Time is represented in HH:MM:SS format.

The Date is represented in DD/MM/YYYY format.

a. On the main screen press the menu key. This will display the

‘MENU’ screen.

b. On the Menu screen press the ‘CLOCK’ key. This action will

display the ‘SET CLOCK’ screen:

Fig. 7- Set Clock Screen

c. Touch the required field (Date/ Time).

d. Use Up and Down keys to modify the field value.

e. Press the SET key to save new clock values.

Pressing the EXIT key will exit the ‘SET CLOCK’ screen without saving.

4.6.2 Selecting the Cycl e

Pressing the Program Icon on the main screen will show the

‘SELECT CYCLE’ screen:

Fig. 8- Select Cycle Screen

This screen displays a list of all available cycles of the machine.

a. Select required cycle using the Up and Down keys.

b. Press SET key to select the required cycle.

Pressing the EXIT key will cancel the ‘SELECT CYCLE’ screen.

Note: Some of the cycles are protected by code.

4.6.3 Setting the Language


‘MENU’ screen.

b. On the Menu screen press the ‘LANGUAGE’ key. This action will

display the ‘LANGUAGE’ screen:

Fig. 9- Language Screen

c. Touch the required language.

d. Press the SET key to change the system language.

Pressing the EXIT key will cancel the ‘LANGUAGE’ screen.

4.6.4 Starti ng the Cycl e

The cycle start is performed from the 'MAIN' screen. Press the 'START' key

Note:

to start the selected cycle.

The 'START' key will be displayed only if the device is ready and 'READY'

message is displayed.

Sometimes starting a new cycle operation is protected by a code. In this

case pressing the 'START' key will open the 'CODE' screen and will enable

inserting the code. After code verification, the cycle will start.

4.6.5 Typi ng the code

In order to perform protected operations, the system will display the code

screen:

Fig. 10- Code Screen

To enter the code:

a. Use the NUMBER keys to enter the code.

b. Press SET key to submit.

In order to clear the code use ‘BACK’ key.

Pressing the EXIT key will cancel the ‘ENTER CODE’ screen.

4.6.6 Chan ging the parameters of the selected cycle

The system allows changing parameters of the selected program.

a. On main screen press the menu key. This will display the ‘MENU’

screen.

b. On ‘MENU’ screen press the ‘OPTIONS’ key. The ‘ENTER CODE’

screen will be displayed. After typing the code and submitting, the system

will display the ‘OPTIONS’ screen:

Fig. 11- Menu Screen

c. Browse the menu list using the UP and DOWN keys

and select 'Change Parameters' option.

d. When 'Change Parameters' option is selected, pressing SET key

will display the ‘PARAMETERS' screen. Only submitted by user-level,

parameters will be displayed.

Fig. 12- Parameters Screen

e. Browse the list using the 'UP' and 'DOWN' keys to select

the required parameter.

f. Press the SET key to submit the selection. ‘SET PARAMETER’ screen will be displayed:

Fig. 13- Set Parameters Screen

g. Use ‘BACK’ key to clear the parameter value field. Use numeric

buttons to type a new value.

h. Press SET key to submit.

Pressing the EXIT key will cancel the ‘CHANGE PARAMETER’ screen.

Note: Parameters are protected by Min/Max values and only allowed

values will be accepted.

4.6.7 C a li b r ati on of a n al og i n pu ts


‘MENU’ screen.

b. On the ‘MENU’ screen press the ‘OPTIONS’ icon. The ‘ENTER CODE’ screen will be displayed. After typing the code and submitting, the

system will display the ‘OPTIONS’ screen.

c. Browse the menu list using the UP and DOWN keys and

select 'Calibration' option. Pressing the SELECT key will display‘ANALOG INPUTS’ screen:

Fig. 14- Analog Inputs Screen

On 'ANALOG INPUTS' screen the names and real-time values of all-analog

inputs which the system has are displayed.

d. Browse the analog inputs list using the UP and DOWN keys

and select the required input. Press Calib key to submit.

Pressing SELECT key will display 'CALIBRATION' screen:

Fig. 15- Calibration Screen

e. Browse the ‘CALIBRATION list using the UP and DOWN

and select the required operation.

4.6.7.1 Available Calibrat ion Operat io ns

Change Gain & Offset – Direct typing of Gain and Offset values.

Calculate Gain & Offset – Calculating Gain and Offset by two points.

Restore Values – Restore Gain and Offset values with factory defaults.

4.6.7.2 Manually Chan ging Gain an d Offset

a. To change the Gain and the Offset, use 'UP' and 'DOWN' keys

and select 'Change GainOffset' option from the ‘CALIBRATION’ list.

Press SET key to submit. ‘SET GAIN OFFSET’ screen will be displayed:

Fig. 16- Set Gain & Offset Screen

b. Use the Left and Right keys to move the cursor the

next/previous field.

c. Use the Up and Down keys to modify the field value.

d. Press SET key to submit.

Press ‘EXIT’ key to cancel.

Note: By pressing the ‘Set’ key, the system saves new values to the

system’s RAM, meaning that if power off happens at this time, new values

will be reset to previous. The system saves Gain and Offset values

permanently to the flash only when going to the ‘OPTIONS’ screen.

4.6.7.3 Calculating Gain and Offset by two points

a. Use the 'UP' and 'DOWN' keys and select 'Calc.

GainOffset' option from the ‘CALIBRATION’ list. Press SELECT key tosubmit. ‘CALC.GAIN OFFSET’ screen will be displayed:

Fig. 17- Calculate Gain & Offset Screen

b. Use Left and Right keys to move the cursor the

next/previous field.

c. Use Up and Down keys to modify the field value.

d. Press SET key , the system will calculate new gain and offset and will save the result automatically.

Pressing the ‘READ’ key will replace current selected field value with

value of the analog input.

Press ‘EXIT’ key to cancel.

Note: By pressing the ‘Set’ key, the system saves new values to the

system’s RAM, meaning that if power off happens at this time, new values

will be reset to previous. The system saves Gain and Offset values

permanently to the flash only when going to the ‘OPTIONS’ screen.

4.6.7.3.1 Calculation explan at ion

The Calculation of the calibration values for the analog inputs (temperature,

pressure) is performed in a digital way and not by adjustment of trimmer

pots.

The temperature and pressure measuring circuits are designed with

components having a 1-% precision. The temperature circuit is linear and

has an output of 100mV÷ 2 4 0 0 mV for a temperature range 20÷150 °C. The

pressure circuit is also linear and has an output of 100mV÷2 400 for a

pressure range 0 to 400 kPa. The measuring at the A/D is void for values

higher than 2400mV or lower than 100mV.

It is clear that even though the precision of the components of the circuit is

1%, the accumulated error can reach 5%, therefore the calibration is

necessary. The system is provided with non-erasable memory in which the

offset and gain data of the sensors are stored. This data may be fed to the

system through programming or through the machine.

This paragraph describes the calibration of temperature and pressure

through the machine, the programming calibration procedure is altogether

identical.

The machine is based on the calculation of offset and gain from two points,

for example if the actual pressure is 100kPa and the system measures and

displays 90kPa and if the actual pressure is 300kPa and the system measure

and displays 310kPa, the graph of the actual and measured values will look

like this:

Fig. 18- Calculation of Gain & Offset by two points

The calibration method enables to introduce these data into the system in

order to perform the automatic correction of the OFFSET and GAIN.

It is recommended to find the two points, which have to be fed to the

system, before performing the calibration.

1. Browse the calibration list using the UP and DOWN keys and select the

required:

a. Read.H: - Read high value of the analog input.

b. Act. H: - Actual high value of the analog input.

c. Read.L: - Read low value of the analog input.

d. Act. L: - Actual low value of the analog input.

4.6.8 Monitoring System’s I/O

The GUI enables to view system’s I/O. The system has analog inputs, digital

inputs and digital outputs.

4.6.8.1 Analog Inputs


‘MENU’ screen.




select 'Analog Inputs' option. Pressing the SET key will display‘ANALOG INPUTS’ screen:

Fig. 19- Analog Inputs Screen (same as fig.14)

4.6.8.2 Digital Inputs/Outputs

a. Browse the menu list using the UP and DOWN keys and

select 'Digital I/O' option. Pressing the SET key will display ‘DIGITALINPUTS & OUTPUTS’ screen:

Fig. 20- Digital Inputs/Outputs Screen

4.6.9 Adjustin g LCD cont rast


‘MENU’ screen.




select ‘Screen Contrast’ option. Pressing the SET key will display‘SCREEN CONTRAST’ screen:

Fig. 21- Contrast Screen

d. Use the UP and DOWN keys to change the contrast.

Pressing the SELECT key will save new contrast.

4.6.10 Proces s History

The system saves last cycle’s printouts and enables printing of the saved

cycles (optional- for device with a printer).

In order to print a cycle from the history:


‘MENU’ screen.




select ‘Cycle History' option. Pressing the ‘SET’ key will display

‘HISTORY’ screen:

Fig. 22- Process History Screen

On the ‘HISTORY’ screen, the list of saved logs is displayed.

d. Browse the history list using the UP and DOWN keys and select the required log.

4.6.11 Ex ternal ke y o p erat io n

The user interface includes four external operating buttons:

Green button: If the chamber is not in operational position, pressing the

green button will bring chamber to operational position and close the door. If

the system is ready, pressing the green button will start the sterilization

cycle.

Red Button: Stops any movement of the chamber and door. When the

sterilizer is in a sterilization cycle, pressing the red button will abort the cycle

and "Manual Stop" indication will be displayed.

Up Button: Pressing this button while the device is not during a sterilization

process will bring the chamber to a LOADING position.

Down button: Pressing this button while the device is not during a sterilization

process will bring the chamber to an UNLOADING position. While the

chamber is in UNLOADING position, pressing the DOWN button will operate

the shredder's motor for 4 seconds and will open the Clean filter valve for 2

seconds. This action is performed in order to help waste to fall out to the bin.

4.6.12 The Tower Lamp

The tower lamp is a signaling device located on top of the

machine, to help visualize the machine status from distance.

The lamp has 4 modes:

Steady RED- A error has occurred. The relevant Error message

will be displayed on the screen in parallel.

Flashing RED – the machine is in process.

Steady GREEN- the machine is ready to start a cyle, or a cycle

has successfully ended. The relevant "Ready" message will be

displayed on the screen in parallel.

Flashing GREEN- the machine is preparing but is not yet ready

(steam is heating, etc.). The relevant "Not Ready" message will

be displayed on the screen in parallel.

Fig. 23-

The Tower Lamp

System messages

4.6.13 Error Messages

System errors are disp layed in RED color on the main screen. When the

device is on process, the error will fai l t h e steriliza t i o n cycl e . The RED

l ight in the towe r lamp will be On. Reset error operation is required in order

to bring the sy stem to the normal mode.

When an error occurs in the sy stem, the ‘Caution’ icon will be

displayed on the main screen.

01-Temp1 Cut.

This message is displayed when the Chamber Temperature sensor fails.

02-Low Temp.

The temperature drops for more than 5 seconds below the sterilization

temperature during ‘Sterilize’ stage.

03-High Temp.

This error occurs in one of the following cases:

Heating Stage:

If chamber temperature is higher than ‘Limit Temperature’ for more than 10

seconds.

Sterilization Stage:

If temperature rises to 3°C (6°F) above sterilization temperature during the

sterilization stage for 10 seconds.

04-Exh Valv.Err.

This error may occur on Standby or Exhaust stages when removing pressure

from the chamber takes a long time.

05-High GenPress.

This error may occur if the steam generator's pressure is too high for any

reason.

06- Pistons error.

This message is displayed when the door operation pistons are found in

unreasonable positions.

07-High Pressure

This message is displayed if the Chamber Pressure raises 40 kPa above

sterilization pressure during the sterilization stage.

08-Low Pressure

This message is displayed if the Chamber Pressure drops 10 kPa below

sterilization pressure during the sterilization stage.

09-Ring Sw. Err.

This message is displayed if the Lock Door mechanism fails.

10-Door SW. Err.

This message is displayed if the Door closed switch is in wrong position.

11-Door Open

This message is displayed if during the sterilization process the system

detects that the door is not closed.

12-Manual Stop

This message is displayed if the sterilization cycle is aborted after the 'STOP'

key is pressed.

13- Air Error

This message is displayed on process when the system fails to pressurize the

chamber with compressed air.

14- Low Vacuum

This message is displayed if the system can't create required vacuum

conditions in the chamber after 20 minutes.

15-Low Heat

This message is displayed if the system can't create required pressure

conditions in the chamber after 20 minutes during the Pre heating and

Heating stages.

16-Press1 Cut

This message is displayed when the Chamber Pressure sensor fails.

17-Chamb Move Err

This message is displayed if the chamber's position is incorrect.

18-Doors Sw Err

This message is displayed when the door switches are in an abnormal

position.

19-Ring Open Err

This message is displayed if the Door's Ring Unlock process fails.

20-Err Water Pump

This message is displayed when the Water Pump which supplies water to

steam generator fails.

21-Test Fail

This message is displayed when the Dynamic Test cycle fails.

22-No I2C Com.

This message is displayed when the communication between the main

electrical board and I/O board fails.

24-Chamb Angle Err

This message is displayed if the chamber's position is incorrect.

25-No Gen.Source

This message is displayed if there is no mineral free water in the reservoir.

4.6.14 Information process and system stat us Messages

'Not ready' messages are displayed in YELL OW or WHITE color to indicate

the device's status on standby. If one of the ‘Stand-by’ messages is

displayed, the ‘START’ button is unavailable and it is not possible to st art

a new cycle.

'Status messages' are displayed in or de r to monito r the device's status

and cycle progress.

No Gen Water

This message is displa yed if there is no water in the generator.

Door Open

The message is displa yed when the Door is no t closed.

No Steam

This message is displayed if the generator pressure is too low. The message

disappears when the pressure is above required pressure.

No Compressed ai r

This message is displayed if compressed air supply has been interrupted.

No Seal Press

This message is displayed if pressure in the sealing is too low.

4.6.14.1 The following messages are displayed in YELLOW when the

chamber is in moving process:

6-OperPos D.Open

The machine is waiting for the door to reach its safety position before

chamber movement.

7-OperPos Go Back

The chamber is moving back

8-L o ad DoorClosed

The machine is wait ing for the door to be completely open when in lo

ad position.

9-Load DoorMiddle

The machine is wait ing for the door to be completely open when in lo

ad position.

10-Load Go Back

The chamber is moving back to Load position.

11-Load Go Forward

The chamber is moving forwar d to Load po sition.

12-Serv.DoorOpen

The machine is waiting for the door to reach its safety position before the

chamber is moving to service position.

13-Serv.Go Back

The chamber is moving back to service po sition.

14-Serv.Go Forward

The chamber is moving forwar d to service position.

15-Unload D.Close


chamber is moving to unload position.

16-Unload D.Open


chamber is moving to unload position.

17-Unload Go Back

The chamber is moving back to unload po sition.

18-Unload GoFrwrd

The chamber is moving forwar d to service position.

19-Limit AT M.Prs

The machine is waiting for the pressure in the chamber to reac h its safety

value before the cham ber is moving.

Safety Sw Off

Main door is open.

Check Safety Sw

Safety Switch is faulty.

Basket miss ing

The trash ba sket (bin) is missing.

4.6.14.2 Exhaust stage messages ( White color):

Exh Water Cooling

Cooling of the chamber through the water sprinkler.

Exh Pres surizing

Pressurizing the cham ber with compr esse d air befo re water removal.

Exh Water Remove

Removing water from the chamber.

Exh Finalizing

The machine is waiting for the safety pressure and temperature in the

chamber.

4.6.14.3 Status Messages:

Status messages are displayed in order to monitor the device's status and

cycle progress.

Ready

This message is displayed on standby stage when the device is ready to

start a new cycle.

FAIL

This message is displayed on standby stage when sterilization cycle fails.

Door Open

This message is displayed on standby stage when the door is open.

Opening Door

This message is displayed on standby stage when the door is on unlocking

process.

Water Inlet

This message is displayed on process when the water inlets to the chamber

the chamber.

Steam O n

This message is displayed on Heating stage when the system creates

pressure by steam in the chamber.

Heating to Ster.

This message is displayed on Heating stage when the system creates

sterilization conditions.

Sterilizin g

This message is displayed on Sterilization stage.

Exhaust

This message is displayed on Exhaust stage.

Dry

This message is displayed on Dry stage.

CYCLE END

This message is displayed on standby stage when the sterilization cycle

successfully ends.

TEST ENDE D

The message is displa yed when the Dynamic Test is finished.

5. Preparation before Sterilization

5.1 Waste Collection and Segregation

The treatm ent in the ISS requires that different kinds of waste shall be

worked up on separately. This requir es responsibility of all involve d

employees at the hospital, so that the segregation of waste is done at

the stage of waste ge neration.

Follow the below recommendations for waste segregation:

Fig. 24- Waste Segregation

Note: Any segregation method to be implemented shall be in

compliance with local rules and regulations.

Note: Bags can be supplied upon request.

The Manufacturer's recommendations concerning the ster ilization of

each ty pe of material/ item shall be taken into consideration.

The followin g types of waste can be pr ocessed in the ISS:

Syringes

Dialyzers

Scalpels

Small textiles (max. 20 %/ load)

Test

Complete Sharps Containers

Food Waste from healthcare fa cilities*

Other Bio-Medical Hazardous Waste

* It is ve ry i m po rtan t to kn o w th at the fo od waste to be steri lize d a nd sh red

de d by ISS sha l l be co nsi s ted o f al re ady coo ke d fo od, th at i s le fto v ers

fro m th e pa tien ts’ meals (co ok e d o r bo iled ve ge tab le s , small pie ces of chi c

ken mea t o r chick en b o nes, l iqui ds, such as water o r sou p, sma l l pie ces o f co

ok ed o r boil e d bee f, small piec es o f b oiled c ow b ones, e t c. ), NOT o f re

mainin g de bri s fro m the kitche n be fore c ook in g food ( l a r ge co w bo nes, b

ee f , unco oke d veg e tabl es, etc.)

According to Medical Waste categorization, prov ided is the allowed

categories: S=sharps; I=isolation waste; L=lab wastes excludi n g

chemical s ; SW=soft wastes such as contaminated bandages and gloves;

LB=limited amounts of blood and b o dy fluids; A=animal waste;

TCT=trace-contamina ted chem otherape utic waste; PH=pha rmaceutical

waste e x c l udin g ch e m ical s .

Place an empty bag into the Waste Bin before starting the cycle. At

the end of the cycle, close th e bag and dispose it a designated

waste collection area . (Note th at the waste is considered

non- hazardous at this stage).

Recommendation: on ce a week, use a biologic al spore test indica tor

(connected to the door) in any load to make sure sterilization is

performed.

5.2 Loading

When loading the waste to be steril iz ed into the chamber, observe the

rules de scribed in this chapter.

Before each cycl e, verify that the door gasket and the surface that

the gasket is pr essed on are clean an d intact.

Do not overload the chamber as th is can have adverse effects on

the results of the sterilization an d drying programs !

CAUTION- during loading and unloading, be carefu l not to slip on

wet floor!

The Operator is instru cted to wear protective measuremen ts (gloves,

long cl oths, bio- mask and glasses) in accordance with local safety

regulati ons and good practice , in order to avoid contact with Bio-

hazardous waste, hot surface, shar p edges or moving parts !

Maxi mu m Load :~25kg o r 1 25 l i te r

Chamber positions during Loading & Unloading:

Fig. 25- Load Position Fig. 26- Unload Position

Chamber position during Cycle:

Fig. 27- Working Position

5.3 Load discharge when process fails

In case of failure, th e chamber will be sealed an d the door remains

closed until a Technician with a special code fixes the problem and

continues the cycle. In any case that the Fail enables completion of the

sterilization process, th e cycle will be forced to continue until steriliz atio n

is reached and the User will get an indication at the end of the cycle on the

type of the failure. The machine cannot be restar ted withou t fixing the error

first.

In case of process fa il, in order to exit th e process, implement the steps

below:

Press on the "CLEAR" button (low er left button on the touch screen).

Type the Technician code in order to complete the RESET process

by alphanumeric table.

Go back to the Main screen and open the door .

5.4 Unloading

On completion of the cycle, the load shall be imme diately removed from

the devie and a visual inspection shall be made to assure that the load is

dry, or that sterilizing indicators have made the required color change.

CAUTION- during loading and unloading, be carefu l not to slip on

wet floor!

The Operator is instru cted to wear protective measuremen ts (gloves,

long cl oths, bio- mask and glasses) in accordance with local safety

regulati ons and good practice , in order to avoid contact with Bio-

hazardous waste, hot surface, shar p edges or moving parts !

DraiElectricityconnection

External

6. Installation Instructions

Only qualified and authorized pe rsonnel are allowed to install,

check, test, maintain and service the devi ce.

Comp. AirInlet

n Outlet

Mineral Free Water connection

SteamConnection

Water Inlet

Fig. 28- Utilities Connection on the rear side of the ISS (illustration)

6.1 Mounting

After unpacking the device, ch eck that the Serial Number (S/N) on its

nameplate corresponds wi th the package number.

Place the device on a level surface, leaving ade quate space of

minimum 4m x 3m, height 2.4m around it for operat ion and service

requirements. (Also see fig. 29 below).

The ambient temperature around the device must not exceed

40ºC and 80% humi d ity.

Do not use the device in presence of dangerous gases and vapors.

The floor in the device area must be Waterproof and non

flammable , with working temperature 150°C or higher.

The floor construction should contain drain hole in the lowest place

of floor. All device ar ea floor co nstruction have to provide incline

toward the drain ho le, in orde r that the rest of the water will be

able to flow out through the drain without obstacles.

The ceiling above the device should be Waterproof and non

flammable with working temperature 150°C or higher. The space

between ceiling and top level of the device is designated to

prevent the steam concentr atio n in the emergency cases, an d the

room shall be we ll ventilated outside.

It is recommended to use Fluore scent lighting. The stroboscopic

effect of the lighting should be minimized in the plant room by the

use of two tube fittings suitably adapted for this purpose or by the

use of two phases for the lighting circuits. The fittings should be

sited longitudinally between the devices.

The access to technician service area shou ld be only for

qualifie d and au thorized pe rs onnel, having prop er in

structions and wh ich have been trai ned by the company.

Fig. 29- Recommendation for Room space for the ISS installation (top view)

6.2 Piping

Connect th e feed wa ter inlet to the wate r reservoir, using a 1/2”

pipe, 3-4 atmospheric bars, with a carbon-active filter.

Connect th e air connector from the device to the building's air

source using a 10/8 mm plastic pneumatic tube, 6-8

atmospheric bars. If there is no external air sour ce use an

independent small air compresso r.

6.3 Drain connections

Connect dr ain outlet box to the drain 2"-4"

Note: The drain bo x is a potential source of contamination.

Therefor e, the place of installatio n is oblige d to:

Usage of an air filter (At the air “chimney” of the drain box).

The connection into the drain water system shall be made in

compliance to local rules and regulations; the user shall be

acquainted with local laws b e fore installation and apply the

local rules.

6.4 Power connection

The device must be connect ed to the Power with a safety

approved Power cord in accordance with local and n a tional

regulations and/or rule s, includin g all required connection: R, S, T,

N, and GND! The minimum allowable current should be 38 A,

or

8AWG square section.

The Ma ximum Length- 2.5m with the Square of cross section at

leas t # 8AWG.

(Illustration only!)

Fig. 30- Power Connection

6.5 Protective Earthing

The Wall fuse box for the device's power supply (400V/50Hz, 32A or

40A) should be equipped wi th a match in g earthing clamp (o r

Earthing screw) at least 8AWG (10mm 2 ).

Avoid direct contact with live parts or areas th at ar e marked with a

"High voltage" sign!

Prel im in a ry ch eck -up

After installation and prior to putting the machine into operation, the

following pr eparing and check-out pr ocedure is to be fulfilled:

Check that the water and drain inlets ar e correctly co nnected to

the utilities and the manual taps on the external line s and on the

device's piping are open.

Check all the manual bypass screws (on the base of the pilot

solenoid valves), are set in neutral position, i.e. the slit on the

head of the screw is set in horizontal position.

Search for leaks and fix piping joints if necessary.

Check at the elec tric al network switchboard, that th e circuit of

the device is switched on and fuses or circuit breakers are not

interrupted, and that the correct voltages are present in the

device's ge nerator co ntrol box, according to the specifications.

Check that circuit breakers in th e control box are switched on.

If the results of the above checkouts are positive, the device is

ready for operation.

6.6 Setting Atmospheric pressure parameter

In case the device is installed in a new geographic loca tion, with

different atmospheric pressure, the At mospheric pressure parameter shall

be adjusted. Changing ATM parameters shall be made as follows:

Menu->Options->Enter Code-> Change Parameters ->ATMPressure.

The parameter's name is: "ATMPressure" and its default value is 100kPa.

In order to adjust the parameter, check what the Atmospheric pressure in

the new location is, and program the value accordingly. (See para. 4.6.6-

Changing the parameters of the selected cycle as a general explanation

of changing parameters).

EXTERNAL DIMENSIONS

Fig. 31- External Dimensions

7. Operating Instructions

Open the feed water manual valve.

Set the incoming compressed air pressure to 8 bar, and set the

regulator's pressure in the machine to 6 bar.

Turn on the main power switch, to power the electric system of the

machine.

Wait until the tower la mp is green and no t flashing, which indicates

the machine is ready, and the display has a "Ready" message.

Watch the pressure parameter on the screen, indicating the rising of

steam pressure. When the pressure reaches 3 bars the

steriliz ation cycle can be started. Open the door.

Load the sterilizer, keeping in mind the recommendations

described in ‘Preparation befo re Steriliz ation' (Para. 5).

Close the door, the word OK appears in the first row, indicating that

the device is ready to start operation.

Press the START key to operate the cycle. The enti re ster i l iz ation

process au tomaticall y proceeds. The 'START' icon on the co

ntrol panel is light.

At the end of the cycle a buzzer sound will be heard continuously,

and the word END will be displayed. Open the door by pressing

the

'DOOR' key. Press the STOP key to cancel the alarm.

N o te : In ca s e of fail e d c y cl e or manual stop by operator,

the reason for failure is displayed on th e screen. At the end of

the cycle an in terrupted sound is heard.

Wait until the chamber reaches its position and the waste is being

evacuated to the bin. (If necessary, press the "Down" butt on to

rotate the blades). Remove the bag filled with waste.

Warning!

Loading or unloadi ng of material from the chamber can be

done only when th e door is open and in the lowest position. It is

forbidden to put a hand or any other part of the bo dy inside the

chamber whil e the door is clos in g. In order to avoid any possible

accide nt, during th e cycle, the machine is clos ed . If the door is

open, th e machine cannot work. Openin g th e door duri ng a

cycle will stop the machine. In case, fo r any reas on, a pers on is

stuck in the loading area while the door is closed, an Emerge ncy

button is mounted in side the machine, behind the display and

the contro l buttons. In case a cycl e fails, th ere is a risk of

contaminant an d biohazard. In this case opening the door is not

allowed.

8. Maintenance Instructions

Warning!

Maintenance tasks are to be performed only providing the

machine is unplugg ed from electrici ty . Before implemen ting

service, maintenance or regular cl eaning, shut the machine off

and unplug it fr om the el ectrical source. It is recommended to

verify that the machine is not powered with a volt meter.

Note: Cleaning of th e machine shall be done accordin g to the

instructions below. Do not apply an y ch emicals, steam or large

quantiti es of water, to avoid ch emical reaction s, damage to the

machine or electrocution hazard.

8.1 Preventive and Peri odical Maintenance

B e fo r e ea

ch cycle

V er i f y t h at th e d o o r gas k et a n d t h e su rf ac e th at t h e ga sk et is

pr es se d o n ar e c l ean a n d i n ta ct .

Use a soft b r ush to cle a n if ne cessary.

Caution! D o not u s e st eel woo l o r steel b r ush as this ca n

damag e the chamber!

da ily

1. Cl ean the g ask et wi th a so ft cl oth.

2. Cl ean the c ha m b er's d oor a r ea with a so ft cl o t h.

3. Run the Cleaning program .

month l y

1. A llow the safet y valv es to blow- T urn the pressure relie f n u

t coun t erclo ckwise for 2 sec ond s.

2. Ch eck tha t manu al val v e s ( b io & ste a m to ch a m be r va lves)

are bloc king th e ch a m b er.

3. (or e v e r y 20 0 cycle s ) - Repla ce th e Bio - f i lter.

4. Ch eck an d tigh ten all fasten ers a n d pa rts o f the d oo r lo c k

ing de vice whe r e nec essa r y.

3 m o nth s

1. Clea n wa ter stra iners on dra i n p i pes w h ile the device is

no t oper ate d (i dl e) .

2. Cle an th e no n-re turn val v e s .

3. Cle a n th e ex hau s t p i pes: ve r i fy se wage pi p e fro m the de vice to

the main se wa ge pi pe i s c l ean. I t is i m po rtan t to pre v en t th e o v

e r fl o w of

th e sewage liqui ds.

4 . C h ec k an d t i ghte n th e p i p i n g co n n ect i o ns w h er e n e c

e s s a r y t o avoid l ea k a g e.

A f ter 50 0 cy cl

es or 6 m o nth s

1. Repl ac e T a p wa te r f i l t e r .

2. Repl ac e RO syste m me mbrane an d fi l t er.

3. Put a fe w drops of lub r i can t on th e doo rs ' h i ng es.

6 m o nth sCl ean wate r stra ine r s on stea m and fe ed wa te r i n le t pipe s whil e t

he de vice do e s no t op era t e (idl e).

ye a r l y

1. Ch eck an d tig h ten th e ele c t r i ca l con nec t i o ns in th e elec

tric al boa rd, c o nne c t ion box , mo tors, e l

ec tr i cal val v es an d i n st rum e n t at i o n w h er e n e c e s s a r y

.

2. Ch eck Mai n swi t ch , Eme r ge nc y Swi t c hes, Doo r Sa fety Swi t

ch, Co n t ac to rs, all Te mpera t u r e and P r e s sure

sen s o r s and th e The r mo sta t . Re cali bra

te whe r e ne cessa ry.

3. Ch eck bel t and re pla c e if ne cessary.

4. Repl ac e G ask et.

5. Repl ac e Comp resse d Ai r Fil t e r .

6. Cl ean the dra i n fi l t e r (on th e wa te r re se rvoi rs, ste a m gene ra

to rs, etc.)

2 ye ars Repl ac e th e ste a m tra p s.

5 ye ars Perfo r m an overall ch e ck of the c ha m b er lo c king syste m and re pla

ce wo rn pa r t s.

A fter 10 00

wo rk ing hours Repl ac e Sh aft seali ng gask e t ( +oil i ng)

A fter 15 00

wo rk ing hours Repl ac e to oth Bel t .

A f ter 30 00

wo rk ing hours

Repl ac e Bearings ( t oge t he r with the seals, the bea ring oil,

and, if ne c e ssary, the O-ring)

A fter 40 00

wo rk ing hours Ch eck the sta t e o f the chain sproc ke t s and re plac e i f ne cessa ry

Note:

Keeping the inside of the chamber clean will lengthen its life

and its pr op er operation.

Periodical Tests

Check all safety devices from time to time and re-regulate if necessary.

Once a year, calibrate and validate the device. Periodical safety tests

derived from local rules, regulations or law shall be applied in

compliance with the la w.

8.2 Maintenance tasks to be carried out regularly

Always carry out the ster ilization cycles in accordance with the

operating manual .

Test the condition of the supply lines of the device at regular

intervals for crac ks or possible mechanical damage. After the end

of a sterilization cycle, close all the valves and taps of the supply

cables, such as those for cooling water and compressed air .

The Sterilizer is equipped with two safety valves, located at the

chamber and the steam generator. As long as the device is

regularly inspected (at least once a year) by an authorized

customer se rvice agent, the prev entive relieving of the valves is not

necessary. To chec k the operation of the safety valves, turn the

pressure relief nut counter cloc kwise for 2 seconds. Verify steam

escapes from the valve. Atte ntio n: Use protective gloves in order

not to burn your hands with the hot steam. Press the STOP key to

interrupt the oper ation, and exha ust steam from the chamber.

8.3 Emergency actions for Cham ber under steam pressure

In case of an emergency situation push the "STOP" emergency

button and disconnect the ma in 3 phase switch (left side of the

electrical box).

Cal l a t e c hnici a n t o solv e th e problem .

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8.4 Troubleshooting

Sym p t o ms

Possi b le c a uses chec k-u p s an d t e sts Corr ect ions

1. Con t rol u nit is no t en ergi zed .

No displ ays a n d ligh t s o n the fro

n t

1 . 1 T he co ntr o l c i r c u i t bre a k er is s w i t c h e d of f .

1.1 C he ck the ci rc ui t b r ea ke r a n d tu rn

the swi t ch o n .

2 . Lo w pr ess u re or n o st eam

pre s sure fro m the ex te rnal sou r c e.

2.1 Lo w p r e ssu re on th e ste a m su pply lin e.

2.2 P r e ssu re re duc er is faul ty or set to o lo w.

2.1 Fix pressure o n th e stea m su pp ly l i ne.

2.2 Se t co rrec tly o r repl ace the pre ssu

re red u ce r.

3. Stea m p r essure go es up beyon d

t h e co nt ro l p o i nt .

3.1 T he ele ctro nic pressure tran sd uce r s

or me asuri ng circui ts a r e faul ty o r ou t o f

calib ra ti on.

3.2 Lea kag e throug h the stea m to coi l val v e .

3.1 Ch eck and cali bra te p r essu re me asuri

ng circui ts o r repla ce tran sdu ce r s.

3.2 Ch eck , fix or repla c e the stea m to c oil

val v e.

4. No ste a m inle t o r lo w stea

m pre s sure.

4.1 Stea m i nle t val v e is bloc ke d o r da maged .

4 . 2 L o w pr es s u r e at t h e st e a m su pp l y li n e .

4.1 Fix or re plac e the ste a m val v e .

4.2 Ch eck the stea m suppl y p r e s sure

as descri bed i n cla use 2 abo ve .

5 . T e mp er at ur e r i s e s ab ov e t h e

pre - se t steri liza t ion val ue.

5.1 Stea m pre s sure i s too hi gh.

5.2 Stea m valve le ak s.

5 . 3 C o n t ro l s y stem pr ob l e m .

5.1 Ch eck and se t th e stea m p r e s sure fro m

th e bu ildi ng sou r c e a n d the pressure redu

ce r corre c t ly.

5.2 Fix or re plac e the ste a m val v e .

5.3 Repl ac e the con trol bo a r ds.

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Sym p t o ms


6. Fast or sl ow exh a ust pha s es

do n o t fu n c t i on ; ch amb e r p r e

ss u r e

re mains hig h o r e xha ust ta kes

too long.

6.1 T he fa st or sl ow ex h a ust va lves is stuck

o r da mag ed.

6.2 Stea m valve le ak s.


6.1 Rep air or re pla ce the d a m ag e d val v e.

6.2 Rep air or re pla ce the stea m valve.


7. D r yi ng stage doe s n ot work. 7.1 Stea m valve le ak s.


7.1 Rep air or re pla ce the stea m valve.


8. Th e a ir in let do es no t wo rk . 8.1 Ai r inl e t val v e is cl o gged or da maged .

8.2 Ai r fi l t e r is ja mmed .

8.1 Rep air or re pla ce the ai r val v e .

8.2 Repl ac e the ai r f i l t er.

9. Un sa ti sfa c tory re sul t s

of s t e r i l i z at io n p r oc es s

.

9.1 Ste r i l iz a t ion c ond itio ns o f i m p r o per

t e mp er at ure or pr es su re to o l o w , st er . t i me

t o o sho r t.

9.2 Inc o rre c t loa d ing of th e Ste r i l i zer, ai r tra p

ped in the loa d .

9.1 Se t th e te m p . and t i me co r re c

t l y acco rd ing to the so rt a nd q uan ti

ty of material.

9.2 Se e p ara. 5 " P repa rati on be fo re

Ste r i l iz a t ion" .

10. D r yi ng i nco mple te - w ast

e re mains w e t.

10.1 In su ff i cien t stea m pressu re.

10.2 Ste a m tra p d oes no t eli m ina t e

the cond en s a t e.

10.3 In co rrec t lo adi ng of the cha m be r.

1 0 . 1 S et or f i x t h e pr es su r e sw it c h.

10.2 Cl ean or re pai r th e ste a m tra p .

10.3 Rel oa d the cha m ber co rrec tl y.

(see para. 5.2)

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Sym p t o ms


11. P r o ble ms rela ted to the con trol

sys t e m .

The keypa d or di spla y i s ou t

of ord er.

No respon se when p r e ssin g a ny k

ey on the ke yb oard. Diso rdered

respo nse to manu al co ntrol s .

P r es s i n g one k e y give s t h e ef fe ct

of pre ssi ng a diffe r en t ke y. Cycle

do es no t s t a r t wh en p r e ssi ng th e

ST A RT

key.

Prin ter do es no t wo rk or pri n ting is

incoh eren t. Wh ile pressing the STO P

key, the syste m do es n o t reac t.

W h i l e s w itch i n g t h e dev i c e

on ,

11.1 Ch eck if th e fla t c able o r MO LEX

conn e c t o r s be tween th e co n t rol b oards

an d keyboa rd a r e we l l pl ug ged i n.

11.2 P ower sup ply ou t of orde r.

11.3 Con t ro l bo ards or keyboa rd faul ty.

11.4 P r in ter Pape r i s mi ssing or qu al ity

is unsu itabl e.

11.5 Fla t c able co nne cti on be twe en c on t rol

boa rd and prin ter is no t plugg ed i n co rrec tl

y. The r e are in te rrup ti ons or l oo s e co ntac

ts.

11.6 P r in ter da mag ed.

1 1 . 7 Tem per at ur e s en s o r is d i sc o nn e ct

ed or loosely co n nec te d. Se nso r d a m a g

ed.

11.8 P r e s sure transduc er i s bad . Mecha nic al

or elec tric al c onne c t ion s or tra nsd uc er da

mage d.

11.1 Fi rmly plug i n th e MOLEX c on nec to rs.

11.2 Fix the po we r sup p ly.

11.3 Rep l a ce th e d e fe cti v e b o a r d of

the mi croco mp uter uni t.

11.4 In se rt a pa pe r roll insi de the prin ter. Mak

e sure you use the co rre ct typ e o f p ape r.

11.5 Pl ug i n th e c onn e cti on or rep lace it.

11.6 Fix co nnec t i o n or re pla ce th e p r in te r.

11.7 Fix co nnec t i on or re pla ce th e se nsor.

11.8 Fix co nnec t i on or re pla ce th e transduc er.

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Sym p t o ms


1 2 . C ham be r d o es not rotate t o

its req ui r ed po sition

12.1 Ang le sen s o r i s d a m aged

12.2 D r i v e malfu nc t io n

12.3 Con t ro l syste m fa i l ure

12. Cal l a T echni cia n

13. Exh a ust is too sl ow 13.1 Fi l t e r i s clogg e d 13. Cle an the d r ai n fi l t er and run the

Cl eani ng p r ogra m. If th e p r ob le m persists,

call a tec h nicia n to cl ean th e c h a m be r fi l t e r .

14. The w ast e h a s n o t been

shred ded well in the ch a m be r

duri ng ste r i l i zation p r oc ess

14.1 In co rrec t lo adi ng of ma te rial in t

he cha m be r ( s ee p ara. 5. 2)

1 4 . 2 S h r edd e r ' s b l ad es ar e d a mage d

14.3 Mo to r malfu n c t io n

14.4 Con t ro l syste m fa i l ure


15. T h e l oa d is moi s t a t th e e n

d of steri liza t i on cycl e

15.1 In co rrec t lo adi ng of ma te rial in th e Ste r i l izer

15.2 T he ai r to ch a m b e r pi ping is b lock ed

1 5 . 3 Com p re s se d a i r sys t em ma l fun ct i o n


16. Do or do es n o t cl ose 16.1 D oo r i s no t c l ea n

16.2 O v e r l o ad/ In te rrup tio n

1 6 . 1 C le a n t he do or and t h e f l an ge

1 6 . 2 V e r i fy th at t h e c h amb e r i s n o t

overl oad ed or tha t th ere is no obj e

ct bloc king th e do or an d/ or th e

flan g e.

of 84

Sym p t o ms


1 7 . Leakage from t h e ma c h i n e One o f t h e v a l v es is faul ty- contin uou s

ly op en

In c a se of de tec t i o n of a leakag e o n

the f l o o r or s u rr oun d in g ar ea , i m me

di at el y:

E v acua te all p e rsonnel a n d sea l the room,

con t act a t echni ci an t o pr ovi d e i n stru cti

o n s a n d co ntact a third pa rty to hand le

the

haz a r d ous su bstances removal.

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9. Valves Numbering

The valves in the draw ing and this manual are numbe red according to it s

function.

1. Separator Valve Water to Separator

2. Water Chamb. Water to Chamber

3a. Steam Chamb. Steam to Chamber

3b. Steam Steam to knife block

4. Clean Filter Compressed Air to chamber

5. Comp. Air Chamb Compressed Air to chamber

6. Bio Filter Out Bio filter to drain

7. Ball valve Exhaust Fast Exhaus t

8. Cooling Drain Cooling to Drain

9. Vac. Valve Vacuum, through the Bio Fi lt er

10. Vac. Water Valv e Separator to Water Pump

11. Main Water Valve Main Water Valve

12. Main Comp. Air Valve Compressed Air Main valve

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10. Spare Parts List

Catalogue No. Part41100033 O-ring for ISS41100034 O ring for ISS 170x4 (FPM)41100035 O ring for ISS 192x4 (FPM)41100046 O ring FPM 62x2,5 for ISS41100047 O ring FPDM 85x2,5 for ISS41100048 O ring FPM 100x3 for ISS41100049 O ring FPM 150x2,5 for ISS41200001 G1/4” filter-regulator for ISS41300001 Valve 1/2 GC 2W41300003 Manual ball-and-socket valve 9100 Type for ISS41300004 Manifold for ISS spool valve41300005 Blanking plate to Manifold for ISSS Spool Valve41400001 Air operated valve brass 2" V101N209 FB41400002 Air operated valve DA-6041400003 Solenoid valve 1/2 SS OMAL 111541400004 Air operated valve DA-1541400005 Air operated valve BN 1/4 24 AC DIN41400006 Air operated valve BN 1/4 24AC 220041400007 Sol-Sol close center ¼-5/3 valve 24VAC, Coil type BN41400009 Solenoid valve on multiple sub-bases (sub-base)41400010 Solenoid valve on multiple sub-bases (header41400011 5/2 1/4” double solenoid pilot valve for ISS41400012 5/3 1/4” double solenoid pilot valve for ISS41400013 5/2 1/4” solenoid pilot valve for ISS41400016 Solenoid for ISS41700001 Non return valve 1/2" brass for ISS41700004 2/2 Way Pilot Operated Valve with Assisted Lift G1/441900001 Water pump Pedrollo PQm60 for ISS43200001 Magnetic sensor for cylinder43300001 Danfoss pressure switch KP35 for ISS43300004 Pressure switch, NO for ISS45000001 Motor for ISS SM 5,5kW 2p IEC 112 B3 400V 50Hz IP5545000002 Motor SM 0,55KW 4P B14 IEC80 400V 50Hz for ISS45200025 Blade for ISS third version knife45200028 Sealing ring for ISS sealing plug45200029 Bronze plug for ISS sealing plug46100001 Sol Spring DF- ¼-5/2 type- BN

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Catalogue No. Part

49000058 Double acting piston without damping & magnetic piston D=20mm,L=70mm,ISS

49000060 Gasket seal for ISS49000062 Simmering for ISS49000063 Simmering (TF/VITON) for ISS49000069 Gear-box CMRV-75 100 80B14 for ISS49000072 Frequency changer 0,7kW 230V 1p for ISS49000073 Frequency changer 5,5kW 400V 3p for ISS49000085 Pneumatic Cylinder ISO 6431 VDMA for ISS49000090 Mini cylinder ISO 643249000091 Mini cylinder ISO 6432 for ISS49000095 Bearing SKF NU 210 ECP_S for ISS49000096 Bearing SKF 6210_S for ISS

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Appendixes:

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Electrical Schematic diagrams of the ISS-

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Piping Schematic diagram of the ISS-

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Pneumatic diagram of the ISS-

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