TECHNICIAN MANUAL
HYDROGEN PEROXIDE LOW TEMPERATURE STERILIZER Models: P50, P80, P110, P160
Cat. No. MAN205-0441001EN Rev. B Tuttnauer Fax:
Europe b.v., Paardeweide 36, 4824 EH, Breda, P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423540
+31/76-5423510,
TABLE OF CONTENTS PARAGRAPH
1
2
GENERAL
PAGE NO.
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1.1
Incoming Inspection Inspection
1.2
Warranty
1.3
Warranty Statement
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4 4 4 4
CHAPTER I – PlazMax STERILIZER DISCRIPTION
5
2.1
5
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PlazMax Sterilizer discription discription
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2.1.1
What is PlazMax?
2.1.2
Warnings and Notes – Low temperature sterilization by PlazMax Sterilizing agent agent
6
2.1.3
Sterilizing agent exclusively for PlazMax
7
2.1.4
Electrical Safety
2.1.5
Components Description with Part Number
2.1.6
Warning Messages
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5
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2.2
2.3
3
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9
10
58
PlazMax sterilizing agent agent action method
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60
2.2.1
New generation sterilization sterilization method
60
2.2.2
Sterilizing Agent properties
61
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Material Sterilization
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2.3.1
Materials which can can be sterilized in the PlazMax
2.3.2
Materials which cannot cannot be sterilized by the PlazMax
2.4
Loading the PlazMax PlazMax sterilization chamber chamber
2.5
Sterilization Cycles
2.6
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2.5.1
Cycle I - Advanced Cycle
2.5.2
Cycle II – Normal Cycle
2.5.3
Cycle III – Endoscopes Cycle
Test Cycles
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2.6.1
Cycle V – Penetration Test
2.6.2
Cycle VI – Leakage Test
2.6.3
Cycle VII – Leakage + Penetration Test
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2.7
Unloading devices sterilized on PlazMax
2.8
Sterilization Process monitoring
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2.8.1
Cycle Report
2.8.2
Chemical Indicator (CI)
2.8.3
Biological Indicator (BI)
2.8.4
Lumen Test – PCD PCD (Process Challenge Challenge Device)
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62 62 62 63 64 64 65 65 66 66 66 66 67 67 67 69 70 72
CHAPTER II – PlazMax STERILIZER INSTALLATION
74
3.1
How to unpack the sterilizer
74
3.2
Installation requirements requirements
3.3
Moving PlazMax sterilizer
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1
75 75
TABLE OF CONTENT (cont.) PARAGRAPH
4
5
PAGE NO.
CHAPTER III – PlazMax OPERATING INSTRUCTIONS 4.1
Sterilizer External Appearance
4.2
Preparing PlazMax for Operation
4.3
Adjusting Date and Time
4.4
Preparation of the sterilization process
4.5
Sterilizing Agent Feeding
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4.5.1
Sterilizing Agent Missing
4.5.2
Refilling:
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CHAPTER IV – MAINTENANCE 5.1
Preventive Maintenance
5.2
Repairing procedures
5.3
Supervision software
5.4
Transducer Calibration
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6
CHAPTER V – FAQ
7
CHAPTER VI – TECHNICAL DATA AND WARRANTY
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ANNEX 1: INSTALLATION PLANS Single Door Model
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Double Door Model
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ANNEX 2: CHECKLIST FOR INSTALLATION AND OPERATIONAL QUALIFICATION
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Installation Qualification and Operational Qualification Check List
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ANNEX 3: PREVENTIVE MAINTENANCE PLAN
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LEVEL 1 MAINTENANCE (Every 6 months or after 750 Cycles) LEVEL 2 MAINTENANCE (Every year or after 1500 Cycles) Other actions to take:
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ANNEX 4: MECHANICAL DRAWING
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2
76 76 77 78 78 85 85 85 89
90 90 91 95 96
100 101 101 101 102 102 103 103 104 105 106
TABLE OF CONTENT (cont.) DRAWINGS
Electrical Switch Board
PAGE NO. ...................................................................................................
Smart-WellTM Incubator Mechanical Drawing 1/2 Mechanical Drawing 2/2
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3
21 71
106 107
1
GENERAL Read the manual carefully, before beginning any operation on the sterilizer!
1.1 Incoming Inspection The sterilizer should be unpacked and inspected for mechanical damage upon receipt. Observe packing method and retain packing materials until the unit has been inspected. Mechanical inspection involves checking for signs of physical damage such as: scratched panel surfaces, broken knobs, etc. If damage is apparent, contact your dealer or point of purchase, so that they may notify the manufacturer and file a claim with the appropriate carrier. All Tuttnauer products are carefully inspected prior to shipment and all reasonable precautions are taken in preparing them for shipment to assure safe arrival at their destination.
1.2 Warranty We certify that this instrument is guaranteed to be free from defects in material and workmanship for one year against faulty components and assembly with the exception of glassware, lamps and heaters. The warranty does not include and does not replace routine treatment and preventive maintenance to be performed according to instructions in this manual. Our obligation is limited to replacing the instrument or parts, after our examination, if within one year after the date of shipment they prove to be defective. This warranty does not apply to any instrument that has been subjected to misuse, neglect, accident or improper installation or application, nor shall it extend to sterilizers that have been repaired or altered by an unauthorized person. The Sterilizer should not be used in a manner not described in this manual!
1.3 Warranty Statement The warranty registration must be completed and returned to our service departments; within fourteen (14) days of purchase or the warranty will be void. Our Technical Service Department can be reached at: Tuttnauer Europe b.v., Paardeweide 36, 4824 EH, Breda, P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423510, Fax: +31/76-5423540, E-mail:
[email protected] Note: If there is any difficulty with this instrument, and the solution is not covered in this manual, contact our representative or us first. Do not attempt to service this instrument yourself. Describe the difficulty as clearly as possible so we may be able to diagnose the problem and provide a prompt solution. If the sterilizer is equipped with a printer, send along a copy of the last printout for our inspection. If replacement parts are needed, stipulate the model and serial number of the machine. No sterilizers will be accepted for repair without proper authorization from us. All transportation charges must be paid both ways by the owner. This warranty will be void if the unit is not purchased from an authorized full service Tuttnauer dealer.
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2
CHAPTER I – PlazMax STERILIZER DISCRIPTION
2.1 PlazMax Sterilizer discription 2.1.1
What is PlazMax? PlazMax is the new low temperature sterilizer studied and prepared to sterilize medical devices in general and thermo-sensitive medical devices. PlazMax sterilization process is based on the hydrogen peroxide vapor injection in a sterilization chamber at a controlled temperature. This equipment has two doors allowing the sanitary barrier, and includes a high vacuum system. The automation system is composed of a computer with a touch screen and a PLC with analogical and digital outputs. Thanks to the vaporizer used in the PlazMax, it is possible to sterilize medical devices with hydrogen peroxide vapor (H2O2) as the sterilizing agent. One of the characteristics of the PlazMax is to enable fast sterilization cycles and a system that allows the dosing into the vaporizer in a complete absence of air. The sterilization chamber is filled with hydrogen peroxide after the relative humidity inside the chamber has been reduced. The sterilization occurs inside the PlazMax chamber by means of hydrogen peroxide saturation. The vaporization drop device has advantages in comparison to the traditional devices, like the precision obtained with the sterilizing agent dripping, by using a capillary tube inside the vaporizer, and the doses variability applied through a computer control system which permanently monitories the device functioning through several pressure and temperature probes. Regarding the injection, the sterilizer has a capillary tube inside the vaporizer, which transforms the liquid into pulverized gas; The sterilization process occurs after reaching 1 mbar pressure in the vaporizer and the whole process occurs in vacuum; The vaporizer is physically open to the chamber and there is no valve between the vaporizer and the chamber. The vaporizer is part of this same chamber; The control system is based on the chamber pressure.
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2.1.2
Warnings and Notes – Low temperature sterilization by PlazMax Sterilizing agent a. Safety gloves
When directly handling the sterilizing agent, you should use safety gloves. You can use gloves for additional safety despite the Sterilizing agent is in a closed bottle and the perforation is done automatically. b. Inhalation
The long exposure to the sterilizing agent can be dangerous. The sterilizing agent vapour inhalation can cause burning and irritation of the respiratory tract. If vapour is inhaled, you should breathe fresh air and if there was a prolonged inhalation, seek medical advice. c. Contact with the eyes
The long exposition to the sterilizing agent can cause irritation and damage to the eyes. The sterilizing agent and its components are not poisonous but can cause irritation. The vapour causes discomfort to the mucous membrane and to the eyes. The contact of the eyes with the sterilizing agent can be very dangerous because it can burn the cornea. d. Contact with skin
The sterilizing agent can cause skin irritation and itching. In case of contact with skin, immediately rinse with plenty of water and seek medical advice. e. Accidental ingestion
Sterilizing agent ingestion can cause serious damages and even death. You must prevent the contact of your mouth with the sterilizing agent. If the sterilizing agent is ingested drink water to dilute it; do not induce vomit and seek medical advice. f.
Storage
We recommend that the bottles are stored in a fresh and dry place and kept away from the sun light, at room temperature.
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2.1.3
Sterilizing agent exclusively for PlazMax a. Sterilizing agent safety
The sterilizing agent safety is assured at two levels: Only the use of recommended sterilizing agent is allowed as the system will only recognize the recommended bottle of PlazMax Sterilizing Agent. Any contact of the operator with the sterilizing agent is avoided since the recharge drawer only opens after the operator indication when the sterilizer warns about the need of a new supply of sterilizing agent. The supplying is possible only after the placing of a new bottle. The refilling begins automatically after the operator’s instruction on the touch screen. The refilling process of the sterilizer is completely automatic, avoiding any accidental contact with the operator. After the automatic emptying of the bottle the drawer opens, allowing the closure of the bottle - using a tap supplied within the recharges kit – and then its removal from the drawer. The bottle can be disposed off in the domestic waste or can be sent to the residual circuit recommended by the hospital’s infection control. The sterilizing agent is not toxic but it is corrosive as it is hydrogen peroxide (H 2O2). Each recharges box includes instructions and recommendations on convenient handling of the sterilizing agent. The sterilizing agent should be stored away from the sun light, at room temperature, preferably in a dry and cool place. b. Dosing system and perforating unit
The dosing system is ensured by an assembly of components that include the drawer for the bottle placing, the perforating unit and the bottle identification unit. A peristaltic pump places the sterilizing agent into the sterilizer tank. The feeding unit also removes the residues remaining in the tubes. The support where the sterilizing agent recharge is placed is made of nylon. When required the drawer opens to allow the bottle insertion. This bottle is automatically transported to the perforation unit and the sterilizing agent is pumped into the tank. To know if the bottle was correctly placed there is a detector that checks the validity and that makes its authentication. The perforator is an electric or pneumatic system which actuates a needle that perforates the bottle and removes the sterilizing agent from its interior.
7
To ensure that no sterilizing agent remains in the tubes, the system injects air into the aspiration circuit. The perforator has an electric or pneumatic cylinder with sensors which determines the position of the movements related with the feeding of the sterilizing agent and informs the operator of any possible malfunction.
Drawer with bottle holder
c. Sterilizing Agent dosing
The sterilizer has a tank which storages the sterilizing agent, from which it is dosed into the sterilization chamber. When the sterilizing agent is missing in the tank, a message is displayed on the touch screen. The operator must supply the sterilizer with sterilizing agent whenever the screen indicates that. The sterilizer does not work if there isn’t enough sterilizing agent for the processing of one cycle. The sterilizing agent feeding can only be done before the cycle start and when the “Refill Sterilizing Agent” button is active. If the recommended bottle is inserted, the system will allow drawer to close, the bottle is punched and the refill of sterilizing agent into the tank is accomplished. At the end of operation, the information is transmitted to the operator on screen.
the the the the
For extra security, when placing the recharges in the drawer, you can use safety gloves. The bottle containing the sterilizing agent has a programmed micro chip including the validity and packaging date of the bottle. When the bottle passes through the refilling unit, the chip program is updated, preventing the reutilization of the same bottle. At the end of the refilling process, the system prints the related data. d. Sterilizing agent leakage
Be sure that the sterilizing agent is recommended for the PlazMax. The use of wrong bottles of sterilizing agent may cause leakage. In case of leakage, use protection gloves and clean with abounding water.
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2.1.4
Electrical Safety PlazMax was made in order to supply a high level of electric safety in what concerns the operator and the technician. All the control system is 24V DC. All the places which can result in electric risk are signalled, that is, high voltage current transformer and respective connections to the electrodes. All the PlazMax ventilation components are 24V DC, except for a few 230V connections: sterilizations’ chamber heating elements, doors’ heating elements, vaporizer heating element, high voltage transformer and vacuum pump. The rest of the components are 24V DC. The PlazMax electrical switchboard has protection and safety components as circuit breakers, relays. There is also a tap on the electric switchboard to avoid accidental contact.
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2.1.5
Components Description with Part Number
1.
Touch Screen A 5.7”.touch screen is placed on the Loading Side panel. In this element you can select the desired cycles and visualize all the cycle phases. This computer has a Windows CE. Note: The software is in a file (NORFlash) inside the WIN CE Operating System. The software name is “HGSterilizator”
Touch Screen Part Nº 400602
10
2.
ON/OFF Button There is an ON/OFF button on the front panel for connecting and disconnecting the PlazMax.
ON/OFF Button (Behind cover) Part Nº 300101
Once turned ON, the sterilization chamber and the doors take around 5 - 10 minutes to warm up and keep at a predefined temperature. If minimum conditions don’t occur then the cycle will not run and a message will be displayed on the touch screen warning the operator about it. When minimum conditions are attained the cycle will run automatically.
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3.
Printer This is a matrix panel printer with memory, where all the cycle data is registered. At the end of each cycle a report is printed including all the cycle phases and the time spent for each phase. The report indicates if the cycle passed or failed. The paper missing is indicated by the red lamp (3) on the front cover.
Matrix Printer Part Nº 401601
Printer External appearance:
2- FEED switch
Front cover Pa er cuttin
3- Paper lamp
art 12- Mounting bracket
4- Knob
5- Ribbon cover Fixed axis Case
12
1- I/F connector
Rear cover
8- PNE sensor
6- Paper holder
Roller
7- PE sensor
Ratings seal 9- DIP switch
11- POWER lamp 10- Back switch
13
Printer Parts description: 1.
7.
The printer can be connected to the signal line of various kinds of host via a cable. Please ensure that both the printer and the host are turned off before connecting or disconnecting. This connector also has a power input. Connect the FG terminal to the earth. Cable connected differs with the interface. FEED Paper is fed while this switch is pressed and switch held. Turning the printer power on while pressing and holding this switch causes self printing to start. In the memory switch setting mode, various kinds of setting are available by pressing this switch. Power lamp Lights/blinks when the paper has become scarce or run out. The lighting status depends on the memory switch setting. Blinks when mechanism error or the like occurs depending on the condition of memory switch setting. knob Used to set paper or to open the front cover when setting or replacing. Ribbon Opened/closed when replacing the ink ribbon cover cassette. Can open when you pull the left side of the front face toward you. Paper Printing paper is set and fixed here. holder Insert the print paper into the paper inlet and then set the paper. PE sensor Detects no paper condition.
8.
PNE sensor
2.
3.
4. 5.
6.
I/F connector (Interface connector)
Detects paper low condition. This function is enabled or disabled depending on the mode or memory switch setting. 9. DIP switch This switch allows basic initial setting. Use this switch before turning on the printer. 10. Back switch Press this switch to use special function. This switch is not used in normal operation. 12. Mounting A bracket to hold the printer body. bracket Hold the printer to the panel or the like by using the two screws supplied.
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Rack mounting: 1. As in the following drawing, insert the main body into the rack; 2. Insert the main body on the rear side with mounting bracket, using the screws to fix it; 3. After fixing the main body, confirm the opening/closing operation of the front panel.
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I/F Cable connection: connection:
Matrix Printer Part Nº 401601 Connection Cable Part Nº 601602
1. Hold the protruding section at the rear of the printer cover and lift it up in the indicated direction. 2. Confirm that the main power supply is off; 3. Assure that the power supply satisfies the voltage and current capacity according to the specifications; 4. Firmly connect, in the appropriate direction, the power supply and the main body of the printer using the attached cable. The connector is at the bottom of the main body as shown in drawing. This cable is larger than the communication cable, which is red, and comes in orange colour for +5V use, and in black for GND. 5. Connect a cable to the power supply. Pay attention not to connect it in reverse polar.
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Opening/closing of the front panel: 1. Apply your finger on the blue projection on the left side of the front panel, pulling it forward when the lock is released. It opens by about 180º centring on the fixed axis. 2. For closing, press the front panel, tightly close it until a click sound is heard. Also confirm on closing that paper is free of slackening. Opening/closing of ribbon cover: 1. When paper is out of the front cover, cut it off; 2. Apply your finger on the dent (indicated by a arrow) on the left side of the ribbon cover, pulling it forward; 3. For closing, press the ribbon cover, close it tightly.
Front cover
Ribbon cover Knob
Setting ribbon cassette: 1. Open the ribbon cover after confirming that the power is turned off. 2. In case the paper is out of front cover, cut or remove it. 3. Check on the correct direction of a new ribbon cassette. Insert the ribbon between the printing head and the platen and press the cassette down from the knob side. 4. Turn the ribbon cassette knob in the arrowed direction and remove slack. On replacing a ribbon cassette, pull it out by holding the “PULL” part.
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Ribbon Cassette Part Nº 401602
Always use ribbon cassettes recommended by Tuttnauer.
18
Setting paper: 1. Open the front panel; 2. Remove the core with the paper holder turned in the arrow direction. Press the FEED switch to remove the remaining paper. Do not pull off the paper forcibly. 3. Use the paper with its end cut straight at right angle or obliquely as shown in the figure; 4. Set the roll paper while turning the paper holder in the arrow direction and placing paper roll core onto the holder; 5.
Insert the end of print paper into the paper insertion slot of the printer. When auto loading function is enabled, paper is loaded automatically. When auto loading function is disabled, insert the paper into the insertion slot while pressing and holding the FEED button. Keep the FEED switch held until paper appears from the paper exit;
6. Eliminate slack on the printing paper and close the front panel. Be sure not to catch paper;
Paper Roll Part Nº 401603
Note: To feed paper, do not pull it forcibly. Always use the FEED switch.
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Paper: 1. Use the paper roll with the beginning of winding (innermost end of the paper roll) treated as follows: 2. No fold and well aligned to inside diameter; 3. No flap; 4. Not pasted to the paper core (if any); 5. Coloured side not facing PNE (Paper Near End) sensor (otherwise, variations in PNE sensor detection may occur.)
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Electrical Switch Board
1 Module. Analogical Inputs (Transducer) Part Nº 400106
Socket Part Nº 601105
2 Modules. Analogical Inputs (probes) Part Nº 400105 6 Modules. Digital Outputs Part Nº 400108
Main Switch Part Nº 402601
1 Module. Top Part Nº 140109 Power Supply 24V. Part Nº 405101 Power Supply 5/12V. Part Nº 405105
1 Module. Digital Inputs Part Nº 400107
Electrical Contactor Part Nº 403601
1 PLC Part Nº 400101 Complete Relay Part Nº 403101 Relay Part Nº 403102
Solid state relay Part Nº 402601
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Connectors “G”
Connectors “F”
Connectors “E” Connectors “A”
Connectors “B”
Connectors “C”
22
Connectors “D”
Electrical Switch Board Connectors List and Labelling (Note: Numbering of all connectors is always from left to right) CONNECTORS “A”
1 2 3 4 5 6 7 8 9 10 11 12
High Voltage Transformer Vacuum Pump Vaporizer Heating Element Door 1 Heating Element Door 2 Heating Element Chamber Heating Element N N N N N N
230V 230V 230V 230V 230V 230V 230V 230V 230V 230V 230V 230V
CONNECTORS “B”
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
N N N N N N N +24V Vaporizer 2 Valve -24V Vaporizer 2 Valve +24V Dirt Zone Door Interlock +24V Clean Zone Door Interlock Tank Pump -24V Tank Pump +24V +24V +24V +24V +24V Top Ventilator -24V Top Ventilator -24V -24V
23
230V 230V 230V 230V 230V 230V 230V Label: EV 2 Label: EV 2 Label: BE 1 Label: BE 2 Label: DOS 2 Label: DOS 2
Label: VT 2 Label: VT 2
Label: RA 1 Label: RA 2 Label: RA 3 Label: RA 4 and RA 5
CONNECTORS “C” Note: Connections from the top 1 +12V – Tank Ventilator 2 -12V – Tank Ventilator 3 -12V – Peltier Plate 4 +12V - Peltier Plate
Label: VT 1 Label: VT 1 Label: PP 1 Label: PP 1
CONNECTORS “D”
1 +24V – Side panel Ventilators 2 -24V - Side panel Ventilators 3 -24V – Dosing Pump 4 +24V – Dosing Pump 5 -24V – Ventilation Valve 6 +24V – Ventilation Valve 7 -24V – Buzzer 8 +24V – Buzzer + - Tank Transducer - - Tank Transducer + - Chamber Transducer - - Chamber Transducer
Label: VT 3 and VT 4 Label: VT 3 and VT 4 Label: DOS 1 Label: DOS 1 Label: EV 1 Label: EV 1
Label: TP 2 Label: TP 2 Label: TP 1 Label: TP 1
CONNECTORS “E”
1 2 3 4 5 6 7 8 9 10 11 12
Label: ST 5 Label: ST 5 Label: ST 6 Label: ST 6 Label: ST 2 Label: ST 2 Label: ST 3 Label: ST 3 Label: ST 4 Label: ST 4 Label: ST 1 Label: ST 1
Burner Probe PT100 Burner Probe PT100 Tank Probe PT100 Tank Probe PT100 Door 1 Probe PT100 Door 1 Probe PT100 Door 2 Probe PT100 Door 2 Probe PT100 Chamber Probe PT100 Chamber Probe PT100 Vaporizer Probe PT100 Vaporizer Probe PT100
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CONNECTORS “F”
1 2 3 4 5 6 7 8 9 10 11 12
Clean Zone Door Switch Input Dirt Zone Door Switch Input Closed Drawer Position Opened Drawer Position Closing Drawer Output Opening Drawer Output Needle Up Position Needle Down Position Needle coming Up Output Needle coming Down Output Drain Valve opening Output Drain Valve closing Output
Label: MI 2 Label: MI 1 Label: MI 4 Label: MI 4
Label: MI 3 Label: MI 3
Label: VV 1 Label: VV 1
CONNECTORS “G”
1 2 3 4 5 6 7 8
T (Hearth) +5V (connection from the top) -5V (connection from the top) -24V +24V ON/OFF Button 230V ON/OFF Button 230V N 230V
Label: IM 1 Label: IM 1 Label: ET 1 Label: ET 1 Label: IG 1 Label: IG 1
Relays Positioning
1 2 3 4 5 6 7 8 9 10
High Voltage Transformer Vacuum Pump Vaporizer Heating Element Door 1 Heating Element Door 2 Heating Element Chamber Heating Element Side panels Ventilators Dosing Pump Inversion Peltier Plate Exhaust Valve
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Label: R 1 Label: R 2 Label: R 3 Label: R 4 Label: R 5 Label: R 6 Label: R 7 Label: R 8 Label: R 9 Label: R 10
Bechkoff modules - Inputs / Outputs Type
Módule
Ref
Digital Input Digital Input Digital Input Digital Input Digital Input Digital Input Digital Input Digital Input
1 1 1 1 1 1 1 1
750-430 750-430 750-430 750-430 750-430 750-430 750-430 750-430
1 5 2 6 3 7 4 8
Sns : Peroxid Aspiration device Up Sns : Peroxid Aspiration device Down Sns : Peroxid Container Out Sns : Peroxid Container In Sns : Peroxid Container Presente Sns : Air Pressur Ok Sns : Dirty Zone Door Closed Sns : Clean Zone Door Closed
Digital Output Digital Output Digital Output Digital Output
2 2 2 2
KL2114 KL2114 KL2114 KL2114
1 5 4 8
Cmd Feeding Pump Cmd Dosing Pump Cmd Vaporizator Pump Valve Cmd Close Escape Valve
Digital Output Digital Output Digital Output Digital Output
3 3 3 3
KL2114 KL2114 KL2114 KL2114
1 5 4 8
Cmd Tank 1 Cool Element Cmd Vaporizator 1 Valve Cmd Vaporizator 2 Heating Element Cmd Ventilation Valve
Digital Output Digital Output Digital Output Digital Output
4 4 4 4
KL2114 KL2114 KL2114 KL2114
1 5 4 8
Cmd Chamber Heating Element Cmd Door 1 Heating Element Cmd Door 2 Heating Elemen Cmd Open Escape Valve
Digital Output Digital Output Digital Output Digital Output
5 5 5 5
KL2114 KL2114 KL2114 KL2114
1 5 4 8
Cmd High Voltage Transformer Cmd Vacuum Pump Cmd Down Needle Cmd Up Needle
Digital Output Digital Output
6 6
KL2114 KL2114
1 5
Digital Output Digital Output
6 6
KL2114 KL2114
4 8
Cmd Safety Main Switch Cmd Out Peroxid Container Cmd Peroxide Purg Valve (Neumatic System) Cmd Invert Dosing Pump
Digital Output Digital Output Digital Output Digital Output
7 7 7 7
KL2114 KL2114 KL2114 KL2114
1 5 4 8
Cmd Dirt Zone Door Unlocked Cmd Clean Zone Door Unlocked Cmd End Cycle Buzzer Cmd In Peroxide Container
Analogic Input - PT100 Analogic Input - PT100 Analogic Input - PT100 Analogic Input - PT100
8 8 8 8
KL3204 KL3204 KL3204 KL3204
1,2 5,6 3,4 7,8
Probe Chamber ProbeTank Cool1 Probe Vaporizator 2 Probe Door 1
Analogic Input - PT100
9
KL3204
1,2
Probe Door 2
26
Connection Description
Type
Módule
Ref
Analogic Input - PT100 Analogic Input - PT100 Analogic Input - PT100
9 9 9
KL3204 KL3204 KL3204
5,6 3,4 7,8
Prob Burner Temperature (free) (free)
Analogic Input - 0/10 V Analogic Input - 0/10 V
10 10
750-452 750-452
1,2 5,6
Transducer Chamber Transducer Tank
1
5
Inp1 Inp2 2
6
Inp3 Inp4 3
7
1
5
Otp1 Otp2 2
6
24V
24V
3
7
0V
0V
4
8
1
5
PT1 PT2 2
6
PT1 PT2 3
7
Connection Description
1
5
AI1+ AI2+ 2
6
AI1-
AI2-
3
7
0V
0V
4
8
Inp5 Inp6
4
8
PT3 PT4 4
8
Inp7 Inp8
Otp3 Otp4
PT3 PT4
750-430
KL2114
KL3204
27
750-452
4.
Sterilization Chamber The sterilization chamber is totally made of a material resistant to corrosion. Inside the chamber there are 4 Teflon rails in order to ensure that there is enough space between the chamber and the basket, providing a correct circulation of the sterilizing agent. You can use gloves to unload the chamber. The chamber heating is made electrically and the temperature is controlled by the control system. The heating elements are installed around the chamber as a coat and are made of a high quality and safe silicone with fibre glass material. STERILIZATION CHAMBER Lock
Door hinge
Chamber door
Teflon rails
Lock holder
Sterilization chamber
CHAMBER ACCESS
It is possible to Access the chamber with probes and Transducer trough clamp connections. Clamp connections Oil Levelto access the chamber Glass
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5.
Vacuum Pump
Oil Level Glass
Vacuum Pump Motor
Humidity Condenser Part Nº 200103
Oil Separator Part Nº 200104
Vacuum Pump Part Nº 200102
Vacuum Pump Exhaust Tube Part Nº 201103
29
6.
Exhaust Valve
Exhaust Valve Part Nº 201602
30
7.
Protection Filters a) Vacuum Pump Inlet-filter – Part Nº 202108 This filter is between the humidity condenser and the Vacuum Pump. It must be cleaned or replaced periodically. It is composed by: 1. Centring-ring and filter assembly 2. O-ring 3. Inlet-port.
b) Chamber exhaust Filter – Part Nº 103604 Clean the mesh filter on the bottom of the chamber periodically.
c) Injection circuit Filter This filter is inside the tube that comes from the peristaltic pump to the injection valve. Use gloves to remove the tube. Clean the filter with abounding water.
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8.
Aeration Filter
Aeration Filter Part Nº 104101
9.
Aeration Valve
Aeration Valve Part Nº 101102
Clamp connections Part Nº 200106 Clamp joint Part N.º 201101
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10. Chamber Transducer
Transducer Part Nº 301602
Clamp connections Part Nº 200106 Clamp joint Part N.º 201101
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11. Doors The doors temperature is around 50ºC. Avoid touching doors. You can use gloves for unloading material from the chamber, especially if you have sensitive skin. The doors ensure PlazMax correct operation and provide a sanitary barrier thanks to micro switches and electromagnetic sealers that keep the doors perfectly sealed during the cycle. The doors are totally made of material resistant to corrosion and warmed up to a controlled temperature. By the end of the cycle, the operator is informed that the cycle has been concluded and the door opening is now available for the PlazMax unloading. The operator can choose the door through which he wants to do the unloading. The two doors cannot be opened simultaneously. Door Hinge
Silicone door gasket Part Nº 202601 Complete Hinge (Plate) Part Nº 922101 Complete Hinge (Nylon door post) Part Nº 922101 Sterilization chamber
Complete Hinge (Hinge dowel pin) Part-No. 922101
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Lock and holder
Hinge dowel pin complete Part-No. 993108
To replace the lock, it is necessary to remove the holder which fixes the micro switch and the door interlock magnet. Micro Switch and Door Interlock Adjustment screws Door interlock Part Nº 100101 Lock holder Part Nº 993101 Adjustment screw Micro Switch Part Nº 300601
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Door Micro Switch Adjustment With the door closed, adjust the screw until establish a contact between points 1 and 2 on the micro switch. Then open and close the door and verify if the contact has been established. If necessary adjust the screw again.
Door Interlock Adjustment - Untie the adjustment screws; -
On the Supervision Software turn ON the interlock;
-
Move the interlock system in order to be possible to open and close the door without blocking in the interlock;
-
On the Supervision Software turn OFF the interlock. The internal mobile parts of the interlock must be loose.
Springs and Nuts for the Door Adjustment
Adjustments Springs and Nuts
When closing the door, place an A4 paper sheet on the lock side and verify that the sheet is pressed between the door gasket and the front side of the sterilization chamber. Adjust the screw nuts near the springs, in order to obtain the same sheet pressing in all the surface of the gasket.
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Door gasket
Silicone door gasket Part Nº 202601
Instructions to replace the door gasket: 1. Open the door; 2. Remove the door gasket; 3. Clean the gasket rail in order to remove the glue waste. You can clean it with a Scotch brit; 4. Place a silicone glue thread in the centre of the rail; 5. Place the gasket without stretching or shrinking; 6. Close the door and wait the silicone glue to dry before using the sterilizer.
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12. Sterilizing Agent Tank The sterilizing agent tank has been designed specifically to store the PlazMax sterilizing agent. Inside the tank there is an electronic reader that informs the PLC and the operator (on the screen) about the available sterilizing agent level in the tank. The tank is totally insulated and has in its side a device that controls and keeps temperature stability. The heat dissipation is ensured by the assembly of a ventilator/fan. This tank has been studied so no pressure can be generated inside.
Sterilant Agent Tank
Circuit tubes Connection unions
Peristaltic Pumps
Cooling system Temperature probe
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13. Burner The burner is totally made of aluminium with two ceramic electrodes and it is fed by a high voltage transformer. In order to ensure that the device works correctly it includes a PT 100 probe which will inform the operator about the burning state at the end of the cycle. The burner has clamps in its entry and exit. This element is placed in the lower side of the sterilization chamber near the exhaust valve in the unclean side. The burning is done inside the chamber where the high tension is placed in order to burn the sterilizing agent. The burner alters the composition of the sterilizing agent, decomposing it into oxygen, water and free radicals.
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Burner spare parts
Clamp connections Part Nº 201102 Clamp joint Part Nº 201101 Temperature probe Part Nº 301101
Electrode Part Nº 202104
Burner body Part Nº 202101 PTFE joint Part Nº 202107
O-ring Part Nº 202105
O-ring Part Nº 202106 Glass Part Nº 202103
Electrode pair Part Nº 202104
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14. High voltage High voltage can cause fatal injuries. The high voltage is used to begin the burning of the sterilizing agent at the sterilization chamber exit. It is dangerous to touch the items with High Voltage sign when the power is “ON”. Verify that the high voltage is “OFF” before doing any related repairing. Preferably disconnect the power supply.
High Voltage Transformer Part Nº 200601
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15. Vaporizer The vaporizer unit is installed on the bottom of the sterilizer chamber. The vaporizer is totally made of stainless steel and is involved by a heating element. The heating is automatic. That type of heating element never flames up by it self, even when submitted to excessive temperatures. If eventually the temperature exceeds 20ºC more than normal, the Main Switch will disconnect. The external side is protected to prevent accidental contact. Temperature is controlled by the control system. The vaporizer is composed by a cylinder with a clamp connection. All the electrical and mechanical connections have a rapid dismantling and the following elements are part of the Vaporizer:
Heater;
Vaporizer Valve;
Capillary tube;
Probe;
Filter.
The vaporizer is mounted on one of the exits of the sterilization chamber and it is controlled by the internal software. In the beginning of each cycle, PlazMax will verify the heating status and the temperature of the sterilizer heating components, including the vaporizer heater.
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Vaporizer Valve Part Nº 101103
Rapid union Part Nº 103109
Capillary tube Part Nº 203102
Vaporizer Part Nº 203103
Rapid curve union Part Nº 103104
Note: When making assembling, all the connections must be well sealed with PTFE strip (not liquid).
Vaporizer Valve
Vaporizer
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16. Peristaltic Pumps Rapid T union Part Nº 103107 Rapid curve union Part Nº 103104 Inside this tube there is a filter
Aspiration tube
Tank Pump Part Nº 100601
Sterilizing Agent Tank
Clamp that fixes the rubber tube holder
Dosing Pump Part Nº 100601
Rubber tube Part Nº 100602
Rubber tube holder
To replace the rubber tube, rotate the clamp to loosen the holder. Then remove the rubber tube from the holder, replace the tube and put it back on the holder. Fix the holder again with the clamp.
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17. Sterilizing Agent Supplying System Supplying system is composed by the drawer that opens to install the recharge bottle on the holder, the RFID reader, and Electrical System (or Compressed air system) to move the Drawer and the Needle that punches the sterilizing agent bottle.
Drawer and Holder for the recharge bottle
Drawer front panel Part Nº 990107
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Bottle holder Part Nº 103601
RFID Reader
Bottle Holder Part Nº 103601
RFID bottle recognizing
RFID reader + Connection cables Part Nº 401101
Replacing the RFID Reader
1. 2. 3. 4. 5.
6. 7. 8.
9.
Remove the drawer front panel untying the screws. Remove the sterilizer lower front panel. On the Supervision Software move the drawer out. Turn OFF the sterilizer. Untie the fixing nut that fixes the holder to the servo motor screw (the screw must be fixed, it can not rotate while doing this operation). Disconnect the PLC cable and the Touch Screen cable. Disconnect the Connectors “G” wires 2 and 3 corresponding to the RFID reader cable. Take the bottle holder with the RFID Reader out of the machine and unscrew the reader from the holder and replace it fir the new reader with cables. Assemble all the components again.
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Drawer with electrical system
Servo Motors 102101 Part Nº 102103
Servo Motor Screw Part Nº 102103
Servo Motor Screw Part Nº 102103
Servo Motor Screw limitation Part Nº 102102
Needle Command Board Part Nº 402101
Drawer Command Board Part Nº 402101
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Drawer and Needle Switches Part Nº 200603
Inside the limitation there is a little screw to fix the limitation to the servo motor screw
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Instructions to disassemble the Drawer and Needle Servo Motors 1. Remove the nuts on the tip of the servo motor screws;
2. Disconnect the switch’s plugs from the command boards; 3. Unscrew the servo motors and remove them; 4. Assemble the new servo motor and make the required connections; 5. Adjust the servo motors movement according to the instructions below.
Instructions to adjust the Drawer movement Loosen the little screws that fix the limitations to the servo motor screw. Rotate the limitations to the left or to the right to limit the total movement of the servo motor screw. The drawer opening movement must be adjusted in a way that allows the operator to insert the sterilizing agent bottle on the drawer holder in a comfortable way. The closing movement must close the drawer till the drawer panel touches the sterilizer panel without forcing it.
After the adjustments, tighten the little screws of the limitations.
Instructions to adjust the Needle movement Loosen the little screws that fix the limitations to the servo motor screw. Rotate the limitations to the left or to the right to limit the total movement of the servo motor screw. The movement of going up must be adjusted in a way that the needle does not come out the guide. The movement of coming down must allow the needle to touch the bottom of the agent bottle without forcing it. After the adjustments, tighten the little screws of the limitations.
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18. Heating Elements PlazMax sterilizer is equipped with the following heating elements: a)
Sterilization chamber heaters
Chamber heater (unclean side) Part Nº 500101
Temperature probe Part Nº 301101
Chamber heater (clean side) Part Nº 500102
In order to disassemble the heater it is necessary to remove the insulation that involves the chamber.
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b)
Doors heaters
The door heater is placed between the door and the holder plate
Fixing Plate Part Nº 500107
Door heater Part Nº 500104
Replacing the door heater:
1. Remove the door handle and dislodge the door panel. 2. Unscrew the fixating nuts of the plate that holds the heater. 3. Disconnect the heater cable. 4. Place de new heater and connect the cable. Assemble all the components again.
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c)
Vaporizer heater
Heating element + Connector with 2 connections Part Nº 500105
Metallic fixers Part Nº 500106
Temperature probe
Replacing the Vaporizer Heating Element
1. Remove the vaporizer isolation and cut the metallic fixers. 2. Disconnect the heater connector. 3. Remove the heater and place the new one. 4. Connect the heater connector. 5. Reassemble the vaporizer isolation and the metallic fixers. Note: The temperature probe that is between the heater and the vaporizer body must be place in the bottom and at the centre of the vaporizer.
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19. Temperature Probes PlazMax sterilizer has several temperature probes at the following components: 1. 2. 3. 4. 5.
Chamber; Doors; Vaporizer; Burner; Tank.
All the probes are equal and all have the same Part Nº 301101 The probes have connectors with 3 connections.
20. Sterilizing Agent Tank Cooling System
Sterilizing Agent Tank
Cooling System: Peltier Plate + Ventilator Part Nº 501109
Cooling block is fixed to the tank with two screws behind the tank isolation.
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21. External Ventilators The PlazMax has two types of ventilators. One is permanent and it is placed on the top of the sterilizer and the others are located on the side panels of the sterilizer and they only work during the cycle. All the Ventilators are 24V.
Grid with protection mesh Part Nº 501104
Grid fixers
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Ventilator Part Nº 501102
22. Feet /Wheels
Foot / wheel Part Nº 994101
The feet are made of anti-skidding material. Thanks to the levelling wheels, it is very easy to move the sterilizer to the place it is going to be installed. To down the wheels, turn the orange/red notched ring on each wheel, clockwise. Once on the installation site, turn the orange/red notched ring on each wheel, counter-clockwise, to low down the feet and lift the wheels. Make sure that the sterilizer is levelled.
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23. Panel’s Knobs
Enchased face
The handle is up locked, just pull the handle Panel handle Part Nº 991603
24. Panel fixing system Rapid nipple lang Part Nº 993601
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4mm Nut
Rapid spring for nipple Part Nº 993602
25. Cover Panels
Top panel Part Nº 990106 Side panel Part Nº 990105
Upper panel of unloading (back) side Part Nº 990103
Lower panel of unloading side Part Nº 990104
Side panel Part Nº 990105 Upper panel of loading side Part Nº 990102
Lower panel of loading side Part Nº 990101
Drawer front panel Part Nº 990107
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2.1.6
Warning Messages PlazMax makes a permanent validation on the different phases. In case of phase failure, the PlazMax will indicate that trough a warning message on the screen. Note: Whenever a failure occurs after the cycle start, the PlazMax processes an emergency aeration or a cleaning cycle.
Missing Sterilizing Agent
If this message persists after refilling, please call technical assistance. Missing StartUp Conditions
This message shows up when a cycle is started having the sterilizer cold. The sterilizer is waiting for temperatures and/or sterilizing agent. When the necessary conditions are achieved, the sterilizer starts up automatically. If this message persists on the screen there is a problem on a probe. Please call technical assistance. PLASMA Temp. FAILURE
Please call technical assistance. Cycle Manually Stopped
This message shows up on the screen every time you RESET the sterilizer. If a cycle was running, the sterilizer will perform automatic functions to allow the doors to open and will indicate FAILED CYCLE. PLASMA FAILURE during Ventilation
Please call technical assistance. Maximum Cycle Time Achieved
Please check the load to verify if eventually you loaded materials which can not be sterilized in the PlazMax sterilizer, or if you loaded too much material.
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PLASMA FAILURE during Exhaustion
Please call technical assistance. Maximum Waiting Time Achieved
Please check the load to verify if eventually you loaded materials which can not be sterilized in the PlazMax sterilizer, or if you loaded too much material. FAILURE DURING DIFFUSION
Please check the load to verify if eventually you loaded materials which can not be sterilized in the PlazMax sterilizer, or if you loaded too much material. Material is NOT IN CONFORMITY
This message shows up at the Test Cycles to indicate the operator that it is not possible to sterilize devices on those cycles. If by mistake materials are loaded on those cycles, these wont be sterilized. FAILED Test
Repeat the cycle to confirm if the failure persists. In that case, call technical assistance. FAILED Leakage Test
Repeat the cycle to confirm if the failure persists. In that case, call technical assistance.
System in Alarm
This message is showed on the touch screen in case of average on the system. Press “Restart”. If the system does not restart call technical assistance.
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2.2 PlazMax sterilizing agent action method The PlazMax sterilizer inactivates the micro-organisms due to the low temperature sterilizing agent vapour, without leaving toxic waste. The PlazMax sterilizing agent is an essential factor for the micro-organisms’ inactivation. This technology can be used for the sterilization of a wide range of medical devices, particularly appropriated for heat and humidity sensitive instruments.
2.2.1
New generation sterilization method PlazMax sterilizer is often called he new generation sterilization method due to the following main reasons: Fastness: The process takes less than 20 minutes for the normal cycle and approximately 30 minutes for the advanced cycle;
The sterilization method only requires electrical energy; The ventilation is not necessary, contrary to the sterilization by gas; The material maximum temperature is less than 55ºC;
Safety: The operator establishes no contact with the sterilizing agent;
Greater adequacy to lumen sterilization; The injection method interacts by considering the quantity of material inside the chamber, allowing a safe sterilization in every possible loading; PlazMax performs self-testing cycles;
Environment friendly: The packaging material is cellulose free;
The process does not consume water;
Low cost: PlazMax cycles are very economic;
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2.2.2
Sterilizing Agent properties The PlazMax sterilizing agent is clear, colourless and it looks like water and has a proper odour. It is not flammable; it is soluble with water independently of the sterilizing agent concentration. The boiling temperature is 115ºC and it freezes at -50ºC. The sterilizing agent is not toxic even if it is corrosive. The PlazMax sterilizer utilizes the sterilizing agent vapour in order to rapidly sterilize medical instruments without leaving toxic waste. Sterilizing agent instructions of use: Before taking the bottle out of the plastic bag, verify that there are no liquid drops or leakage inside this bag (in case of sterilizing agent leakage, use safety gloves in order to take the bottle off the plastic bag and clean it before putting it onto the drawer holder).
Take the bottle off the plastic bag;
Place the bottle on the drawer holder.
Take the bottle cap off, only after placing the bottle on the holder.
In case of skin contact with the sterilizing agent, clean immediately with abounding water. In case of injury or feeling unwell, seek medical advice, and if possible, show the product label.
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2.3 Material Sterilization 2.3.1
Materials which can be sterilized in the PlazMax
2.3.2
Metals Any material that manufacturers recommend to be sterilized by this method. Stainless steel 300 series Aluminium 6000series Titanium Non metals Acrylonitrite butadiene styrene (ABS) Delrin EVA (Etheyl vinyl acetate) Fluorinated ethylene propylene (PTFE) Glass, USP type I borosilicate Low density polyethylene Latex Low density polyethylene Monel Neoprene rubber (polychloroprene) Nylon Phenolic resin Polycarbonate Polyethylene terephthalate (PET) Poly (methyl methacrylate (PMMA) Poly (phenyl sulfone) Polypropylene Polystyrene Polysulfone Teflon (PTFE) Polyurethane Polyvinyl chloride (PVC) Silicone
Materials which cannot be sterilized by the PlazMax
Absorbent materials (cellulose); Wood, linen, paper, spongeous materials; Liquids; Powder; Oil; Instruments with lumen, having less than 1 mm diameter and over 10 m length.
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2.4 Loading the PlazMax sterilization chamber The PlazMax chamber has 4 PTFE guiding rails to assure the existence of space between the chamber walls and the materials, allowing the free circulation of sterilizing agent. We recommend that all sterilization material should be packed in polypropylene or tyvek pouches. We do not recommend the use of cellulose variations or tissue for the packaging of the medical devices, because these materials are sterilizing agent absorbent and turn the ventilation more difficult. The materials to be sterilized must have been properly processed. They must be clean and completely dry. Note: If you overload the sterilizer, you must close the door and wait for 5 minutes before starting the cycle.
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2.5 Sterilization Cycles PlazMax sterilizer has three Sterilization Cycles as follows:
2.5.1
Cycle I - Advanced Cycle It is similar to the Normal Cycle, but with Diffusion phases much longer. The Advanced Cycle is used for the general medical devices sterilization, including lumen and hollow instruments, in containers or pouches. It takes approximately 30 minutes. The essays made with the PlazMax PCDs (Lumen Kit) confirm that Advanced Cycle has the capacity to sterilize the following lumen:
Diameter ≥ 1 mm and extension ≤ 3 meters, with one closed end. Diameter opened.
≥ 1
mm and extension
≤ 10
meters, with both ends
The Advanced Cycle is composed by two phases of Preparation for Diffusion, two phases of Diffusion, two phases of Exhaustion of the sterilizing agent and Ventilation. This is how the cycle runs:
Phase 1: Exhaustion: This is a vacuum and humidity exhaustion phase and it runs during a few minutes. Phase 2: Preparation for Diffusion: This phase consists on creating, in the chamber and vaporizer, conditions for the diffusion. Phase 3: Diffusion: In this phase, an aqueous solution of sterilizing agent is injected into the chamber and diffused after being vaporized. The sterilizing agent diffuses in the chamber by surrounding the items to sterilize and starting de micro-organisms inactivation.
Phase 4: Sterilizing agent (Plasma) Exhaustion: In this phase, the chamber is in exhaustion and all the gas removed from the chamber is burnt.
Phase 5: Preparation for Diffusion 2
Phase 6: Diffusion 2
Phase 7: Sterilizing agent (Plasma) Exhaustion 2
Phase 8: Ventilation: Here the chamber is ventilated so no waste of sterilizing agent remains on the material. End of Program: At the end of the cycle, a report about the cycle phases is processed and the operator is informed if the cycle was done successfully or if it failed. At the end of the cycle it is possible to open the doors.
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2.5.2
Cycle II – Normal Cycle The Normal Cycle is used for the superficial sterilization with fast process. It can be used for medical devices sterilization, that accidentally have contact with the floor. This cycle is not recommended for hollow devices. But, the essays made with the PlazMax PCDs (Lumen Kit) confirm that Normal Cycle has the capacity to sterilize the following lumen:
Diameter ≥ 1 mm and extension ≤ 2 meters, with one closed end Diameter opened
≥
1 mm and extension
≤
5 meters, with both ends
The process takes less than 20 minutes, depending on the medical devices type. The Normal Cycle is composed by two phases of Preparation for Diffusion, two phases of Diffusion and two phases of Sterilizing agent Exhaustion. The cycle runs as follows:
Phase 1: Exhaustion;
Phase 2: Preparation for Diffusion;
Phase 3: Diffusion;
Phase 4: Sterilizing agent (Plasma) Exhaustion;
Phase 5: Preparation for Diffusion 2;
Phase 6: Diffusion 2;
Phase 7: Sterilizing agent (Plasma) Exhaustion 2;
Phase 8: Ventilation;
End of Program.
At the end of the cycle, a report is generated with the cycle phases and informing if the cycle was done successfully or if it failed. At the end of the cycle you can open the doors.
2.5.3
Cycle III – Endoscopes Cycle The Endoscopes Cycle is used for the sterilization of Flexible Endoscopes only. It sterilizes one or two endoscopes. The essays made with the PlazMax PCDs (Lumen Kit) confirm that this cycle has the capacity to sterilize the following lumen:
Diameter ≥ 1 mm and extension ≤ 3 meters, with one closed end Diameter opened.
≥ 1
mm and extension
≤ 10
meters, with both ends
The process takes about 35 minutes. Endoscopes Cycle is similar to Advanced Cycle but the Exhaustion phase is longer and temperatures are lower. 65
2.6 Test Cycles Besides the sterilization cycles PlazMax sterilizer also performs Test Cycles:
2.6.1
Cycle V – Penetration Test Composed by one phase of Preparation for Diffusion, one phase of Diffusion and one phase of Sterilizing agent Exhaustion. The cycle runs as follows:
Phase 1: Exhaustion;
Phase 2: Preparation for Diffusion;
Phase 3: Diffusion;
Phase 4: Sterilizing agent (Plasma) Exhaustion;
Phase 5: Ventilation; End of Program.
This test is validated by the operator, by placing lumen PCDs (Process Challenge Device) with chemical and biological indicators 105, inside the sterilization chamber, and by checking the indicators results at the end of the cycle. In this cycle you must use the following PCDs:
2.6.2
Lumen with 5 meters, with both ends opened Lumen with 2 meters, with one end closed
Cycle VI – Leakage Test This is to check the sterilization chamber tightness. Consists on a submission of the chamber to a vacuum, with a stop of the Vacuum Pump and the drain valve closed, on a time counting, and on a verification of the pressure variations inside the chamber.
2.6.3
Cycle VII – Leakage + Penetration Test It is possible to perform both Leakage and Penetration Tests consecutively. The operator must remember to place the PCDs with the chemical and biological indicators, inside the chamber, as indicated for the Penetration Test.
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2.7 Unloading devices sterilized on PlazMax When the cycle is finished correctly, the operator is informed that one of the doors can be accessed. The operator has the possibility to choose which door will be open, knowing that opening one of the doors prevents the opening of the opposite one. In case of a failed cycle it is only possible to open the loading door (Unclean Side).
2.8 Sterilization Process monitoring PlazMax sterilization process can be monitored by four different means: Cycle Report printout Chemical Indicators Biological Indicators Lumen Test - PCD
2.8.1
Cycle Report After the sound signal which informs the end of the cycle, the sterilization process data is printed out. The operator must check the cycle result on the Report printed out, to verify that the cycle was concluded properly. Examples of Reports are found on the next page. Whenever the PlazMax needs maintenance, a message will be written in the cycle report warning about this fact. After each refilling of sterilizing agent the system will print the refilling data also. At the end of the cycle remove the printout from the printer.
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Examples of Cycles Reports
The Report includes data like the type and number of cycle, the several phases, the result, total time of the cycle, and space for the operator signature.
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2.8.2
Chemical Indicator (CI) The chemical indicators are used to detect if there was enough sterilizing agent inside the packs, indicating the result of the medical devices processing. The CI for the PlazMax completely responds to the period of exposition to the sterilizing agent, assuring its efficiency. We recommend placing one strip of SteriTec chemical indicator Cross-Checks P (ref. CI 115) inside in each pack to be sterilized.
Chemical indicator for hydrogene peroxide
Purple
Sterilant agent exposure
Pink
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2.8.3
Biological Indicator (BI) BIs are used for the sterilization process monitoring, Tap with incor orated CI
Plastic tube
Breakable glass ampoule
Stainless steel disc
The EZTest BIs have a defined quantity of inoculated spores in a small disc in stainless steel placed inside a plastic tube with the breakable glass ampoule which includes a culture media. We recommend the use of SGM EZTest (ref. EZH/6) biological indicators. They are available for hydrogen peroxide plasma sterilization processes, and have Geobacillus Stearothermophilus spores. The culture media changes its colour from purple to yellow when the culture is positive. After the sterilization process, the BI must be incubated according to the manufacturer instructions. If the sterilization process fails, the BI changes its colour from purple to yellow. If the BI remains purple it means that the sterilization was successful. The BI cap has a CI which turns from blue to pink when exposed to the sterilizing agent.
In case the CI does not change its colour in a pack, the sterilization of this pack shoul NOTE: The BI must be placed in sealed pouch before being placed in the chamber.
No colour change, there is no bacteriological grow.
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Change of colour to yellow. It means that the sterilization process failed
Smart-WellTM Incubator
Features:
Fast biological positive results in 3 – 5 hours of incubation; Really biological system; Easy evaluation step by step; Automatic documentation; Alarm in case of sterilization process fail; 100% verifiable results.
“ SPORES DON’T LIE”
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2.8.4
Lumen Test – PCD (Process Challenge Device) a. Lumen Kit The sterilization process monitoring can be performed with flexible lumen kits.
In the kit, there are two types of lumen: opened on both sides and opened only on one side. The difference is only the total length of the lumen.
10 meter Lumen: Consists on a chamber for the indicators positioning and on each side of the chamber a capillary 5 meters long with 1 mm of diameter. 5 meter Lumen: Consist on a chamber for the indicators positioning and on each side of the chamber a capillary 2,5 meters long with 1 mm of diameter. 3 meter Lumen: Consists on a chamber for the indicators positioning, sealed on one of the sides and having a capillary 3 meters long with 1 mm of diameter on the other side. 2 meter Lumen: Consists on a chamber for the indicators positioning, sealed on one of the sides and having a capillary 2 meters long with 1 mm of diameter on the other side.
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b. How to use the lumen kit (PCD)
1. Prepare the PCD; 2. Verify if the lumen is cleaned (free of water drops and/or dust); 3. Place a chemical and a biological indicator 10 5 into the PCD chamber;
4. Place the PCD with the indicators inside the sterilizer chamber; Note: Also a biological indicator EZTest 106 must be placed in sterilizer chamber, outside the PCD. 5. Process the cycle; Note: These are the PCDs you must use for the following cycles: Advanced Cycle 4 PCD’s (10 meters, 5 meters, 3 meters and 2 meters) Normal Cycle
2 PCD’s (5 meters and 2 meters)
Endoscopes Cycle
4 PCD’s (10 meters, 5 meters, 3 meters and 2 meters)
Penetration Cycle
2 PCD’s (5 meters and 2 meters)
6. Remove the PCD from the chamber; 7. Verify the chemical indicator result and incubate de biological indicator in a suitable incubator. c. What to do in case of lumen test failure
If the chemical indicator does not show colour change, repeat the cycle to confirm if the failure remains. In that case, contact your PlazMax distributor for technical assistance.
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3
CHAPTER II – PlazMax STERILIZER INSTALLATION
3.1 How to unpack the sterilizer 1. If the pack is damaged during transport, inform your supplier immediately. 2. Unpack the machine in a ample space. 3. Remove the external packing. 4. Remove the fixing screws that hold the machine to the pallet. 5. Lift the machine using the rising supports (fig. 1). 6. Before placing the machine on the ground check if the wheels are down and the feet are up.
Wooden walls Pallet
Fig. 1 7. Once on the installation site, rotate the toothed wheel in the base of each one of the wheels counter-clockwise, to lift the wheels and leave the machine on the feet. Make sure that the sterilizer is levelled. NOTE: The feet are made of anti-skidding material.
FOOT DOWN
FOOT UP AND WHEEL DOWN
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3.2 Installation requirements 1. The PlazMax electric supply is 230V AC mono-phase (frequency 50/60 HZ). The voltage must correspond to the required one; 2. The sterilizer energy consumption is approximately 4 kW. The available power on the place where the sterilizer is being installed must be over 4 kW; 3. Verify if this place offers the required electric specifications; 4. Confirm the supplied voltage; 5. The voltage must be mono-phase; 6. In a normal situation the room temperature should be kept between 15 and 40ºC for the sterilization process to run efficiently;
Installation plan:
PlazMax sterilizer must be installed according to the plans on ANNEX 1 on this manual. Installation Qualification and Operational Qualification Checklist is on ANNEX 2.
3.3 Moving PlazMax sterilizer Thanks to the levelling wheels, it is very easy to move the sterilizer to the place it is going to be installed and then level it. The machine must be moved on its own base since it has wheels that make that easier. Once on the installation site, low the sterilizer feet following the instructions on this Chapter.
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4
CHAPTER III – PlazMax OPERATING INSTRUCTIONS
4.1 Sterilizer External Appearance
4.2 ON/OFF Button Behind cover
Touch Screen
Matrix Printer
Chamber Loading Door Sterilizing Agent Supplying Drawer
Cabinet Base
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Preparing PlazMax for Operation 1. Remove the touch screen protection; 2. Take out the screw caps on the sterilizing supply drawer. Unscrew de drawer panel and remove it. Remove the lower front panel and verify the vacuum pump oil level. The oil must be between minimum and maximum level marks;
Oil level glass
3. Take out the lower panel on the clean side and remove the sterilizing agent box, ATTENTION The doors are blocked for transport/shipping. To unblock them proceed as follows:
4. Connect the sterilizer to the electric power; 5. Push ON/OFF button on the Unclean Side panel; 6. Supply the sterilizer with sterilizing agent (following the touch screen instructions); 7. Select one of the programmes and the unclean side door will be unblocked. Open the door and remove the User Manual and any other items that have been placed inside the chamber;
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4.3 Adjusting Date and Time 1. Press “Maintenance” button on the left upper side of the touch screen; 2. Press “Setup” button; 3. Press “Date/Time”; 4. Adjust the Time using the buttons “+” and “-“; 5. Press “>>” under the Time to validate the inserted time; 6. Adjust the Date using the buttons “+” and “-“; 7. Press “>>” under the Date to validate the inserted date; 8. Press “Exit” to return to the Main Menu
4.4 Preparation of the sterilization process 1. Choose the intended cycle on the Touch Screen:
Cycle I – Advanced Cycle
Cycle II - Normal Cycle
Cycle III – Endoscopes Cycle
Screen 2 – Test Cycles (access code required)
Below you will find an image of the Main Screen. Main Screen: Maintenance 12:00:00 PM
Cycle I - Advanced Cycle II - Normal Cycle III - Endoscopes
SCREEN 2
Sterilizing Agent Level
Sterilant Agent Level information
Refill Sterilant Agent
Refilling Sterilant Agent Button
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2. Open the door and place the material baskets inside the chamber 3. Close the door and press “ Start Cycle” on the touch screen.
12:00:00 PM
Cycle I Advanced
Start Cycle Return
It is possible to return to the main menu if you want to change the cycle
Note: If you wish to run a cycle different than the selected one, you can do
that without the need to open the doors. Instead of pressing “Start Cycle” you press “Return”. On the Main Menu you select the desired cycle. In case the PlazMax has been switched off for a long time it will take 5 to 10 minutes to warm up. If there are no conditions to start the cycle, the screen will inform that the sterilizer is waiting for conditions
12:00:00 PM
Cycle I Advanced Program starts after conditio ns exist
Return
When the conditions exist the cycle starts automatically.
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Exhaustion Phase: Reset 12:00:00 PM Cycle N. 1
Cycle I Advanced
Exhaustion
Preparation for Diffusion Phase: Reset 12:00:00 PM Cycle N. 1
Cycle I Advanced
Preparation for Diffusio n
Diffusion Phase: Reset 12:00:00 PM Cycle N. 1
Cycle I Advanced
Diffusion
NOTE: You can abort the cycle pressing “Reset”, but, after diffusion phase, before opening the door, the sterilizer will process a cleaning cycle. If it was not running the diffusion phase it will execute the ventilation process. This operation can take a few minutes because the machine will complete the phase in order to open the Loading (Unclean side) door safely.
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Plasma Exhaustion Phase: Reset 12:00:00 PM Cycle N. 1
Cycle I Advanced
PLASMA EXHAUSTION
Preparation for new Diffusion: Reset 12:00:00 PM Cycle N. 1
Cycle I Advanced
Preparation for Diffu sion 2
Diffusion 2 Phase: Reset 12:00:00 PM Cycle N. 1
Cycle I Advanced
Diffusion 2
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Plasma Exhaustion 2 Phase: Reset 12:00:00 PM Cycle N. 1
Cycle I Advanced
PLASMA EXHAUSTION 2
Sterilization Chamber Ventilation Phase: Reset 12:00:00 PM Cycle N. 1
Cycle I Advanced
Ventilation
End of Program:
End of Program
Empty the Chamber
The screen shows the message to empty the chamber.
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End of Program
Close the Door, Confirm on Screen
End of Program
Return to Main Screen
Cycles run automatically. At the end of a Cycle properly concluded you will hear a continuous sound alarm, and the printer will printout a report with the cycle data. The operator must check the message on the touch screen and the data on the printout. In case of failure, this will be displayed on the screen and you will hear an intermittent sound alarm. The report will be printed out also.
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Test Cycles
To enter the Test Cycles, press “SCREEN 2” on the Main Menu Maintenance 12:00:00 PM
Cycle I - Advanced Cycle II - Normal Cycle III - Endoscopes
SCREEN 2
Sterilant Agent Level
Refill Sterilant Agent
Then you can choose the desired test cycle by pressing the related button Maintenance 12:00:00 PM
Out of Service Cycle V – Penetration TEST Cycle VI – Leakage TEST Cycle VII – Leakage + Penetration Return
NOTE: For the Leakage Test Cycle the screen will display “Test Properly Concluded” or “FAILED Test”. The operator must confirm with OK on the screen. The printout will always say “Material is not in Conformity” because on the sterilization point of view a test cycle is always a failed cycle.
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4.5 Sterilizing Agent Feeding 4.5.1
Sterilizing Agent Missing The sterilizer has a tank where it stores the sterilizing agent, dosing it automatically into the sterilization chamber. A level indicator displayed on the touch screen offers real time information to the operator. A warning message “Sterilizing Agent Missing” will be displayed if the level of sterilizing agent in the tank goes too low or runs out. The sterilizer will not operate if the tank doesn’t have enough agent to run a cycle. The sterilizing agent refilling can only be done before starting a cycle and when the “Refill Sterilizing Agent” is active. If the operator does not verify the need to refill the tank, the sterilizer will even so, run some cycles before displaying the message to refill the Sterilizing Agent. Maintenance 12:00:00 PM
Sterilant Agent Missi ng
Sterilant Agent Level
Sterilant Agent Level indication
Refill Sterilant Agent
4.5.2
Refilling: 1. To refill the sterilizing agent tank, press “Refill Sterilizing Agent” button on the Main Menu; Maintenance 12:00:00 PM
Cycle I - Advanced Cycle II - Normal Cycle III - Endoscopes Sterilant Agent Level
SCREEN 2
Refilling Button Refill Sterilant Agent
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2. Follow the handling instructions for the Sterilizing Agent that are inside the Sterilizing Agent package. 3. The supplying drawer will open and you can place the bottle in the holder. Only the recommended bottles will allow the operation to proceed. Without the recommended bottle the drawer will not close.
Refilling Sterilant Agent
Drawer Sliding Out …
4. Once the system recognizes the bottle, the drawer will close. Press “Start Refilling”.
Refilling Sterilant Agent Press Button to Start Refilling
Start Refilling Exit
NOTE: When placing a new recharge of sterilizing agent, the system will recognize it automatically, due to the RFID installed in each bottle that contains the information about the expire date, lot number and packaging date; When passing on the refilling system, the RFID will change its program preventing the use of the same bottle again.
The tank can support only one bottle; For extra precaution, gloves can be used when placing the bottles in the drawer.
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5. The message “Refilling Sterilizing Agent” will be displayed on the screen.
Refilling Sterilant Agent Refilling running – Punching Please wait 119s
6. During this phase the needle will punch the bottle membrane.
Refilling Sterilant Agent Refilling running – Aspiration Please wait 119s
7. During this phase the system is aspirating the agent to the tank.
Refilling Sterilant Agent Refilling running – Cleaning Please wait 8s
8. During this phase the system is cleaning the Sterilizing agent tubing.
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9. When the refilling is complete, a message will be displayed on the screen indicating that the bottle can be removed. The drawer will slide out.
Refilling Sterilant Agent Remove Bottle …
Slide In Drawer
10. Place the cap on the bottle; 11. Remove the bottle from the drawer; 12. Press the “Slide In Drawer” and the system will close the drawer automatically;
Refilling Sterilant Agent Drawer Sliding In …
13. The refilling is complete;
Refilling Sterilant Agent End of Refilling
Exit
14. Press “Exit” to return to the Main Menu. 15. After each refilling operation, the system will print a report with the refilling data. 88
5
CHAPTER IV – MAINTENANCE The maintenance purpose is to keep the good operating conditions of the machine. It consists in periodically verifying or replacing parts in the PlazMax. Maintenance MUST be done by authorized technicians, following the instructions on this Manual. When the maintenance is not periodically followed, a warning message will be printed out on the cycle report. From the Main Menu you can access some maintenance activities.
Button to access Setup.
Maintenance
With the code 11335577 the technician will be able to open or close the ventilation valve. To enter press “Ventilation Valve”.
12:00:00 PM
Setup Cycle I - Advanced
Exit
Cycle II - Normal Cycle III - Endoscopes
To set the Date and Time press “Date and Time”.
SCREEN 2
Sterilant Agent Level
To select the desired language press “Language”. If by mistake the technician “Exit” button instead of “Setup”, the system will exit the program returning to WIN CE. In that case it is necessary to turn off the sterilizer on the ON/OFF switch and turn it on again. Under no circumstance the technician should touch any of the files on WIN CE, unless with specific instructions from Tuttnauer people. That could damage PlazMax software.
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5.1 Preventive Maintenance The maintenance of the equipment must be done by Tuttnauer technicians or personnel with PlazMax training. Periodically, it is necessary to do Preventive Maintenance, such as:
Cleaning and/or replacement of some components;
Cleaning of the electrical command zone.
Preventive Maintenance must be done as shown in the tables on ANNEX 3.
5.2 Repairing procedures All the repairing must be done by technician personnel or personnel with PlazMax training. We recommend that you use protective gloves every time you need to handle components containing sterilizing agent. In this manual, you can find photos of the sterilizer components’ position with instructions of how to dismount them.
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5.3 Supervision software This software has been developed in order to make it easier for the technician to access all the operations occurring on the sterilizer software. The supervision software is able to display the pressure and temperature values of the components, and it permits to verify if the components are ON or OFF (when the component is ON it is shown in blue colour, when it is OFF it is shown in red colour). The software is also able to verify the time spent for each phase. The Supervision Software is composed of an HGSterilizator-Remote.exe file and an HGSterilizator.LNG languages file. To work, this software must be installed in a portable PC and be connected to the Touch Screen with a Crossover Cable like the shown below:
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The computer where the software will be installed must have the net configurations with the appropriated Ethernet code.
WIN XP windows:
IP address: 10.9.7.0 255.255.252.0
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SUPERVISION SOFTWARE WINDOW
It is possible to turn ON or OFF the Digital Inputs and Outputs by pressing with the mouse button.
Real values read
Required values
This box informs about the temporizer waiting, temperature and pressure values and alarms about conditions that need to be achieved for the cycle to start.
Real value
Required value or time
While the cycle is running it is possible to change the current phase time.
Note: It is not possible to turn ON a heating element if the temperature is equal or higher that the internal control of the machine. If a cycle is not running, it is possible to open or close every element on this window.
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SUPERVISION SOFTWARE AUXILIARY WINDOW
Clicking twice with mouse left button on the white box will open a new window.
New window. Clicking twice on the white box you can insert the number of cycles to the next maintenance.
There are two supervision software versions, one of them allows you to transfer encrypted files to the Touch Screen and the other one allows the connection and disconnection of the valves. This manual includes only the one that allows the connection and disconnection of the valves. All the software text is in English but it can be translated to your local language.
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5.4 Transducer Calibration This calibration Kit is available under request. With this kit it is possible to calibrate the sterilizer pressure and temperature.
Pressure transducer
PT 100 probe for the chamber temperature PT 100 probe for PT 100 probes comparison
Power supply
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6
CHAPTER V – FAQ Can I sterilize flexible endoscopes? Yes, but they must not be rolled inside the involucres and they must have the lumen ends open. Can I use common paper in the PlazMax? Yes, but it must be in very small amounts, for example, very small labels. The common paper absorbs the sterilizing agent removing it from the chamber, especially near the labels, and will result in more sterilizing agent waste. What kind of material should I use for the packaging? For the packaging, you should use polypropylene or Tyvek You should use pouches or paper prepared for this sterilization method, recommended by Tuttnauer. What kind of indicators should I use? You should use SGM H2O2 EZTest biological indicators with a population of 1.1 x 106 Geobacillus Stearothermophilus (ref. EZH/6) placed in the load. The BI is a container like the BI used in the steam sterilizers, but has the particularity of the Geobacillus Stearothermophilus being inoculated on a stainless steel disc. Our range of tests includes a BI with a population of 10 5 (ref. EZH/5) which has been developed with the purpose to be placed inside a lumen PCD also developed for this test. Our range of products also includes an Incubator with reduced incubation time of 3 to 5 hours for positive cultures. Note: This incubation system is not indicated for the BIs placed inside the lumen PCDs. Inside each pack, besides the BI, you must include PlazMax chemical indicators. How can I validate the sterilizer? Our Company’s service department has qualified personnel to validate the sterilizers. The validation kit is a small equipment which can be mounted near the PlazMax. It is independent of the automation and validates independently all the cycle data, informing the operator if the cycle passed according to the manufacturer graphs and a complete executed cycle report is supplied. .
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How can I interpret the sterilizer report? At the end of the cycle, the PlazMax prints out a report of the various cycle phases and the time spent in each phase. It records any fail during the cycle and a blank space is available so the operator can sign and validate the report. If necessary, other print outs can be done by accessing saved data. In each report are included the cycle file name saved in the system (that will be year, month, day and cycle number processed in this particular day - e.g. 20070312001). This operation is only possible if no cycle is running at the moment. Basically, the report informs that all the phases have been passed. In case of phase failure, it will appear in the report. The report indicates if the cycle passed or not. The sterilizing agent refilling can also be recorded. What is the danger level of this sterilizer? The PlazMax does not emit toxic gas. (Sterilizing agent is corrosive, but not toxic). What precautions should be considered on cleaning the PlazMax? To clean the sterilizer chamber you must turn on the sterilizer and select on of the cycles, so the doors can be unlooked. Turn off the sterilizer until the cleaning is finished. The sterilization chamber can be cleaned with a wet cloth and water. The water should not be placed directly into the chamber because it damages the vacuum pump. After the cleaning, the door should be kept open until the chamber is completely dry. Periodically, the chamber exhaustion filter must be cleaned or replaced. The chamber must be cleaned every week due to natural deposit of dust. The outside surfaces can be cleaned with appropriated cleaners. In our PlazMax range of products we have the suitable cleaners. All the cleaning actions must be done at the beginning of the day when the machine is cold. Can I burn myself when operating the PlazMax? No. The chamber and doors temperature is around 55ºC which cannot lead to accidental burnings. Nevertheless, if you have a sensitive skin, you should use gloves when unloading the chamber at the end of the cycle as the material should still be hot. How should I clean the touch screen? First you have to turn the machine “OFF” and then you can clean it with a wet cloth or with some special product for cleaning PC screens.
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Is there any risk of explosion? There is no danger. The cycle runs in vacuum. PlazMax is programmed to report any irregular situation. The equipment was developed with high concern about the personnel safety. When refilling the sterilizing agent, it is not possible to touch it directly. If you have any question, please contact the production and manufacturing department for further information. Who should do the PlazMax’s maintenance? The maintenance should only be done by the manufacturer and recommended companies with a PlazMax training. The PlazMax may have a telemaintenance service. This service is activated according to the agreement made between the manufacturer and the hospital. It’s possible, using an Ethernet connection, to verify from our facilities the entire PlazMax components and show all the information in the sterilizer screen and all the steps that should be followed. By these means, any qualified technician can replace the damaged parts that were recommended by the machine’s report. Can I use some other kind of sterilizing agent in the PlazMax? No. You cannot use any product which is not recommended for use with this equipment. PlazMax has been studied and developed together with the sterilizing agent PlazMax. It is not possible to introduce any other kind of sterilizing agent in the sterilizer tank because the PlazMax has a calculation system that detects if any non recommended sterilizing agent has been introduced. Any attempt to refill manually the PlazMax tank will be detected and PlazMax will be blocked after some cycles until the authorized technician intervention. Tuttnauer company will not take responsibility for the use of other Sterilizing Agent that is not PlazMax, or for the resulting damages. What should I do if there is an average? You have to read and note any information given by the machine. Refer to the user manual for any help. If you do not find the needed information, you should contact the manufacturer or the authorized agent. Together with your user manual you will get a Non Conformity record sheet. Please record on it all verified malfunctions, breakdowns or strange situations. These must be reported to your PlazMax supplier or manufacturer. This information is very important and will support us on constant improvement of PlazMax equipment, and for customer’s satisfaction.
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How can I buy PlazMax products? You can buy directly from the manufacturer, or from the exclusive distributors. Who has developed the PlazMax? PlazMax has been developed by a large and young team. The basis was the new method of using hydrogen peroxide as a sterilizing agent, which patent process is in registration phase. This team tried hard to make the machine performing, ergonomic, safe and also attractive. Soon, you will find in our website the names of the elements that made this project possible. If you have any opinion about the PlazMax, do not hesitate in sending it to the manufacturer and we will be pleased to take it in consideration. Our customer’s opinion is very important to us. What is the best place to install the PlazMax? The PlazMax should be placed in any ventilated room as the unit releases heat. Furthermore, concerning the two doors units, it must be mounted in sanitary barrier zones, like CSSD. The PlazMax does not require any specific connection it only requires an electrical power supply. The PlazMax includes, as an option, stainless steel sections to fix the sterilizer to the wall. How does the cycle run? The sterilizer has been studied in order to have fast cycles and even to be able to sterilize lumen. Basically, in the chamber, the cycle runs in high vacuum which is attained thanks to the most innovative vacuum technology and a double stage vacuum pump. After an initial vacuum, air is injected into the chamber by a Hepa filter in order to remove any possible humidity from the instruments to be sterilized and to lead it to the drain trap by means of the vacuum system. After the second vacuum phase, the sterilizing agent is injected into the chamber and the diffusion phase begins. After the Diffusion phase comes the exhaustion and the sterilizing agent burning phases. After the burning phase, a chamber ventilation phase follows and the cycle is concluded. Finally a report is printed out.
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7
CHAPTER VI – TECHNICAL DATA AND WARRANTY Technical Data P50 1D
P50 2D
P80 1D
P80 2D
P100 1D
P100 2D
P160 2D
1
2
1
2
1
2
2
Useful Volume
44 Lt
44 Lt
81 Lt
81 Lt
107 Lt
107 Lt
158 Lt
Total volume
47 Lt
47 Lt
83 Lt
83 Lt
109 Lt
109 Lt
162 Lt
W
420
420
420
420
420
420
420
H
180
180
320
320
420
420
420
D
620
620
620
620
620
620
920
W
700
700
700
700
700
700
700
H
1580
1580
1700
1700
1800
1800
1800
D
640
640
640
640
640
640
940
MODELS Doors
Chamber Dimensions (mm)
Sterilizer External Dimensions (mm) Weight
170 Kg 170 Kg 200 Kg 200 Kg 210 Kg 210 Kg 270 Kg 230 V
230 V
230 V
230 V
380 V
380 V
380 V
Power Frequency 50 Hz Supply
50 Hz
50 Hz
50 Hz
50 Hz
50 Hz
50 Hz
2,9 kW 2,9 kW
3 kW
3 kW
5 kW
5 kW
7 kW
Voltage
Power
Warranty
To keep the warranty valid, the PlazMax must be used under the recommendations instructed by Tuttnauer, in the User and Maintenance Manuals.
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ANNEX 1: INSTALLATION PLANS Installation Plans Single Door Model
Wall 50 cm
Chamber door m c 0 5
Front
l l a W
Single door sterilizer – view from the top
Double Door Model
Clean Side
Wall
Wall
Left Side
Right Side
Wall
Wall
Unclean Side
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ANNEX 2: CHECKLIST FOR INSTALLATION AND OPERATIONAL QUALIFICATION Installation Qualification and Operational Qualification Check List
Installation qualification
Site with 30 cm between the wall and the ventilators Electrical connection of 230 V Equipment is levelled Verify the vacuum pump oil level Remove the user manual from the sterilization chamber before connecting the machine Turn “ON” the machine Sterilizing agent feeding before cycles’ processing Place the ribbon cassette in the printer Verify the printer start up message Verify date and time The assembling is done according to the plan
Operational qualification
Process an empty normal cycle with lumen PCD with biological and chemical indicators Process an empty advanced cycle with Lumen PCD with biological and chemical indicators
Date: Technician:
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OK
Fail
ANNEX 3: PREVENTIVE MAINTENANCE PLAN Components that should be verified/replaced during the maintenance: LEVEL 1 MAINTENANCE (Every 6 months or after 750 Cycles)
Component
Verify Replace X
Vacuum pump oil;
Every 6 Months
Every Year
Cycles
X
750
Pump entry filter;
X
X
750
Vaporizer entry valve;
X
X
750
Chamber heater;
X
X
750
Doors heater;
X
X
750
Doors Switch’s;
X
X
750
Doors Hinge and Lock;
X
X
750
Vaporizer heater;
X
X
750
Bottle perforation system;
X
X
750
Drawer opening system;
X
X
750
Vaporizer filter valve
X
X
750
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LEVEL 2 MAINTENANCE (Every year or after 1500 Cycles)
Component
Verify
Replac e X
Door gasket;
Every very 6 Months Year
Cycles
X
1500
Drain valve;
X
X
1500
Condenser;
X
X
1500
Clamp gasket;
X
X
1500
HEPA filter;
X
X
1500
Burner electrodes;
X
X
1500
Burner “O” rings;
X
X
1500
Vaporizer valve
X
X
1500
Vaporizer capillary tube
X
X
1500
Unions and Tubes of Sterilizing agent circuit Peristaltic pumps rubbers
X
X
1500
X
1500
X
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Other actions to take: Every 6 Months
Action to take:
Every Year
Cicles
Vacuum test
X
750
Lumen test
X
750
Clean the sterilization chamber
X
750
Adjust Power supply voltage
X
750
Ventilators cleaning
X
750
Verify unions and tubes of compressed air circuit (if applicable)
X
750
Verify Command valves (if applicable)
X
750
Clean compressed air tank (if applicable)
X
750
Verify compressor pressure switch (if applicable)
X
750
Probes Calibration
X
1500
Transducers Calibration
X
1500
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ANNEX 4: MECHANICAL DRAWING Mechanical drawing 1/2
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