PANDA Bench Top Sterilizer System User Manual Rev 0 July 2012

Revision History REV

ISSUE DATE

REASON FOR CHANGE

Rev-A

2008.12.18

First Issue

Rev-B

2010.01.01

Version Change

Rev-C

2011.08.31

Version Change

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained by the Manufacturer. If you require the latest revision, please contact your distributor, sales representative, or service dept.

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Regulatory Requirements Conformance Standards The content of this instruction is fit for sterilizers. The above sterilizer is in accordance with the requirements of European Class B: 93/42/EEC 97/23/EC EN 61010-1 EN 61010-2-040: EN 13060 EN 61326-1

European Authorized Representative DNA Consulting G.C.V. Address: Burgemeester Jean Neyberghlaan 41–Bus 014 B-1090 Jette (Brussels) Belgium Tel: + (32) (0) 496 / 341 884 This product complies with the regulatory requirement of the following: • Council Directive 93/42/EEC concerning medical devices: The CE label affixed to the product testifies compliance to the Directive. The location of the CE marking is shown in this manual.

Certifications Manufacturer is ISO 9001 and ISO 13485 certified.

Original Documentation The original document was written in English.

Declaration of Conformity Council Directive 93/42/EEC concerning medical devices: The CE label affixed to the product testifies compliance to the Directive. The location of the CE marking is shown in this manual. In this manual there are present the CE Certification and the Conformity. Review the appendices.

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Table of Content Regulatory Requirement...1 Revision History...2 Regulatory Requirements...3 Table of Content ...4 Chapter 1 Introduction...6 1.1 Attention ...6 1.2 Usage Indications ...6 1.3 Contraindication...6 Chapter 2 Safety...7 2.1 Explanation Symbol...7 2.2 General Safety Recommendations...9 2.3 Safety Parts ...10 2.3 Operation Risk ... 11 2.4 Protection Device ... 11 Chapter 3 Receiving and Installation ...12 3.1 Check the Package ...12 3.2 Unpacking the Accessories ...12 3.3 Optional Accessories...13 3.4 Installation Environment...13 3.5 Set...13 3.6 Power Connection ...14 Chapter 4 Description and Specification ...15 4.1 Front View of the Sterilizer...15 4.2 Rear View of Sterilizer...16 4.3 Opened View of Sterilizer ...16 4.4 External Size ...17 4.5 Loading Size ...17 4.6 Specification...17 4.7 Sterilization Cycle ...19 4.8 Internal Printer ...19 Chapter 5 Panel and Functions ...20 5.1 Controlling Panel（pic 5-1）...20 5.2 Menu ...21 5.3 Window of Sterilization Process ...29 Chapter 6 Operation Process ...31 6.1 Power On...31

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6.2 Distilled Water Adding...31 6.3 Alarming If Used Water Reservoir Is Full ...32 6.4 Selecting Sterilizing Program ...32 6.5 Loading Instrument ...33 6.6 Closing The Door...34 6.7 Starting a Working Cycle ...35 6.8 End Of The Sterilization Working Cycle. ...36 6.9 Power Off ...36 6.10 Abnormal Exiting...37 6.11 Sudden Power Off ...38 Chapter 7 Essential Information...40 7.1 Please Ensure the Following...40 7.2 And Please Do Not...40 Chapter 8 Maintenance...41 8.1 Maintenance Schedule Chart ...41 8.2 Daily Maintenance ...41 8.3 Weekly Maintenance (More Often If Necessary) ...42 8.4 Monthly Maintenance ...43 8.5 Other Maintenance...44 Chapter 9 Servicing By the Approved Technician ...45 Chapter 10 Transportation and Storage ...46 10.1 Preparation before Transportation and Storage ...46 10.2 Draining ...46 10.3 Conditions For Transportation And Storage ...46 10.4 Package ...46 Appendix 1 Instrument Which Need To Sterilize...47 Appendix 2 Alarm List...48 Appendix 3 Electric and Hydraulic Drawings...49 Hydraulic Drawing...49 Electric Drawing(E MODEL)...50 Appendix 4 The Standards Of Testing ...51

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Chapter 1 Introduction 1.1 Attention v

This manual contains necessary and sufficient information to operate the unit safely, and with optimal efficiency and reliability. This manual also outlines the regular and

correct servicing requirements. v

Read and understand all instructions in this manual before attempting to use the product.

v

Keep this manual with the equipment at all times. Periodically review the procedures for operation and safety precautions.

1.2 Usage Indications Application to all wrapped or non-wrapped, solid, hollow load products type A and porous products or related articles. This sterilizer is suitable for use in the following environments: dental clinics, laboratories, surgical rooms, emergency rooms, cosmetic hospitals and so on. It is recommended that the unit be operated by doctors and professionals with appropriate training and knowledge.

1.3 Contraindication There is no contraindication of this equipment.

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Chapter 2 Safety 2.1 Explanation Symbol Device Icon Description “ATTENTION” – Consult accompanying documents” is intended to alert the user to refer to the operator manual or other instructions when complete information cannot be provided on the label. “ATTENTION” – Pay attention to the high temperatures in the chamber, and to the sterilizer exterior when the system is in operation with particular care during the exhausting stage. “Protective Earth” - Indicates the protective earth (grounding) terminal.

“CAUTION” - Dangerous voltage” (the lightning flash with arrowhead) is used to indicate electric shock hazards.

Label Icon Description Symbol for "SERIAL

Symbol for

NUMBER"

"MANUFACTURER"

Symbol for "CATALOGUE

Symbol for "AUTHORISED

NUMBER"

REPRESENTATIVE IN THE EUROPEAN COMMUNITY

Symbol for "DATE OF

Symbol for "CAUTION"

MANUFACTURE"

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Manual Prompt Note Caution

Indicates pertinent information which is will assist with use of the unit or is highly helpful with unit operation Indicates that a potential hazard may exist which through inappropriate conditions or actions will or can cause: • Minor injury • Property damage. • Damage to machine

Warning

Indicates that a specific hazard is known to exist which through inappropriate conditions or actions may cause: •

Severe personal injury

•

Substantial property damage

•

Substantial damage to machine

NOTE: Indicates precautions or recommendations that should be used in the operation.

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2.2 General Safety Recommendations v

The user is responsible for operation and servicing the sterilizer in accordance with the instructions listed in this manual.

v

This sterilizer is not suitable for liquid processing and should NOT be used for liquids.

v

The sterilizer has not been designed to operate in the presence of gas or explosive vapours.

v

The trays and the load will still be hot at the end of each cycle. Use the tray holder to remove each tray from the chamber.

v

Do not open the door of the chamber during the sterilization cycle.

v

Do not put your hands or face on the cover of the water tank when the sterilizer is running.

v

Do not remove the instruction plate or any label from the sterilizer.

v

Do not pour water or any other liquid over the sterilizer.

v

Do not fill caustic liquid into the water tank.

v

Do not fill caustic matter in the chamber.

v

Use only high quality distilled water.

v

Unplug the mains lead before inspecting or servicing the machine.

v

Only an approved technician using original spare parts should carry out repairs and maintenance.

v

In case of transport, drain both water tanks completely, allow the sterilization chamber to cool down and preferably use the original packaging.

v

The articles under sterilization should be removed by special tools when the temperature is over 40℃.

v

Handling of the sterilizing trays should be done by use of the special tools provided.

v

During transportation, the sterilizer should be handled by two people.

v

Notice! This product must be placed in a location such that access to the power supply is easily accessible. Never place the unit in a location where the power supply is inaccessible.

v

Do not cover the water tank during usage

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2.3 Safety Parts Temperature Protection Part Name

Function

Temperature Protector

Cut off current when the steam generator temperature is too

(Steam Generator)

high.

Temperature Protector

Cut off current when the heating ring temperature is too high.

(Heating Ring) Electronic Protection Part Name Double Fuse

Function Will be broken circuit if the connected power is too high or unstable.

Electronic Filter

Will filter the electromagnetic interference during operation

Mechanical Protection Part Name Jiggle Switch

Function To ensure the door is closed completely for avoiding the risk of safety

Tray Tong

Avoid scald when removing articles from the chamber

Control Part Part Name Temperature Sensor

Function To measure temperature inside the chamber

(Inside Chamber) Temperature Sensor

To measure the heating ring temperature

(Heating Ring) Temperature Sensor

To measure steam generator temperature

(Steam Generator) Pressure Sensor

To measure chamber pressure

PCB Control

Control system for controlling the process of sterilization

CAUTION

MANUFACTURER IS NOT HELD RESPONSIBLE FOR ANY ARBITRARY DISASSEMBLY, AMENDMENT OF THE UNIT, BY UNAUTHORIZED PERSON OR UNPROFESSIONAL TECHNICIAN.

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2.3 Operation Risk Please take attention to avoid risk during operation. Scald risk v

At the completion of every cycle, please keep an appropriate distance, as the chamber may still have rudimental steam with high temperature, precaution must be taken to avoid scalding.

v

At the completion of every cycle, please do not touch the main door and chamber, due to the risk of high temperature, and possible scalding.

Pollution risk Please clean the chamber after every use to avoid rudimental contamination left inside chamber

2.4 Protection Device Device Name Heat resistant glove

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Function Recommended during loading and unloading of articles, to avoid scalding.

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Chapter 3 Receiving and Installation 3.1 Check the Package Please inspect packaging and labelling when you receive the product.

Front

Flank

Item

18 Model

23 Model

Packing Size

652×549×486mm

762×549×486mm

Packing Weight

59kg

66kg

3.2 Unpacking the Accessories Open the package and remove the product, remove the plastic bag, open the chamber door to inspect all the accessories and check as followed:

No.

Part Name

Qty

1

Tray frame

1 piece

2

Trays

3 sets

3

Tray removal tong

1 piece

4

Draining tube

1 piece

5

Adding water tube

1 piece

6

Power supply cable

1 piece

7

Door gasket

1 piece

8

Operation manual

1 piece

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2

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3.3 Optional Accessories Name

Model

QTY

Memory

≥ 1G

1

Disk

Picture

3.4 Installation Environment The sterilizer should be located such that there is a minimum clear distance of 10cm on each side and 20cm clear above the unit, adequate loading and unloading space in front of the unit is required as followed:

The sterilizer should be located with good ventilation. The temperature of the environment: 5-40℃. The humidity of the environment: ≤85% Atmosphere pressure: 70KPa ~ 106KPa An earth connection is required. CAUTION

DO NOT L OC ATE AN Y AR TI CL E S WHI CH ARE HE AT S E NS I TI V E NE AR THE S TE RI L IZ E R.

3.5 Location v

The sterilizer should be located on a stable level surface.

v

The sterilizer cooling and vent area must be clear with adequate ventilation space as directed above. NEVER COVER.

v

Do not put anything on the top of the sterilizer.

v

Do not put anything in front of the door, to avoid accident when opening the door.

v

Do not put any corrosive items near the sterilizer to avoid accident or risk.

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3.6 Power Connection v

The sterilizer should be connected with a stable and separated power source.

v

The power socket is located at the back of the sterilizer

v

Please confirm the connection of the power complies with the specification of the nameplate at the back of sterilizer.

CAUTION

DO NOT BEND THE POWER CORD TO AVOID DAMAGE DO NOT PUT ANY HEAVY ACTICLES ON THE POWER CORD TO AVOID DAMAGE DO NOT USE OTHER POWER CORDS TO AVOID DAMAGE TO THE STERILIZER

Wrong

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Chapter 4 Description and Specification 4.1 Front View of the Sterilizer

4 8

7

9

3

2

1

Name

6

5

Description

1．Drainage Port

For Main Water tank

2．Filling Water Port

For automatic water fill.

3．Drainage Port

For used water tank

4．Filling Water Port

Manually

5．Internal Printer

Internal printer to print sterilization record after completed cycle.

6．USB Port

Insert memory disk to save a sterilization record after completed cycle.

7．Power Supply Switch

Main power switch

8．Displaying W indow

Display of temperature, pressure or other sterilization information during the cycle.

9．Door Handle

Pull out door handle with safety lock to open and close the door.

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4.2 Rear View of Sterilizer

15 12

14

11

13

10

Name

Description

10．Power socket

Connect power source

11．Fuse

Unit protection when the power is unstable.

12．Print out port

Service port and secondary output port

13．Relief Valve

Over pressure chamber protection.

14．Nameplate

Basic information of Manufacturer

15．Vent area

Output heat from the condenser vent.

4.3 Opened View of Sterilizer

16 18

19 17

Name 16. Air Filter

Description Filtered air to chamber.

17. Door Gasket

For sealing the door

18. Tray Holder

To load the sterilized instruments.

19. Pressure Protector

It ensure the door cannot be opened when chamber with pressure or during the cycle.

(For E model) Or Electronic Locker (For Ei model)

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4.4 External Size

Item

LK/MMQ.D0.020

LK/MMQ.D0.025

Size of Closed Door

557×471×401

667×471×401

Size of Opened Door

827×471×401

987×471×401

4.5 Loading Size The loading size of the sterilizer is as shown:

LK/MMQ.D0.020

LK/MMQ.D0.025

4.6 Specification Basic specification Rated Voltage: a.c.220V-230V, 50Hz Rated power: 1500VA（LK/MMQ.D0.020） 1700VA（LK/MMQ.D0.025） Fuse: T10A Operation temperature: 5～40℃ The board affording weight: 4000 N/m

2

Noise :< 50db The maximum capacity of a plate: 1000g The frequency of water drainage: once a day, drain the water when the system indicates “waste water over” during operation. The maximum duration of test cycle: 90mins. The maximum thermal radiation energy under the condition of 20℃~26℃ :<2000J.

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Sterilizer chamber: Material: Medical grade stainless steel Maximum Working Pressure: 2.3 bar Minimum Working Pressure: -0.9 bar Maximum Operating Temperature: 136℃ Chamber volume: 18L (Φ245×320mm) 23L (Φ245×450mm) Loading size: 18L (198×204×319) 23L (198×204×385) 2

Max. Loading weight: 18L (3.07kg/cm )

2

23L (3.21kg/cm )

Working Pressure/Temperature: 1.10～1.30bar/121℃~122℃；2.10～2.30bar/134℃~135℃ Water volume for one cycle: 0.16L（min）0.18L（max）

Sterilizer steam safety valve: Safety release pressure: 2.5 bar

Water tank Main water tank volume: 18L (3.5L) CAUTION

23L (4L)

WATER ADDED INTO MAIN WATER TANK MUST BE DISTILLED WATER! WATER TEMPERATURE MUST BELOW 40℃

Used water tank volume: 18L (3.5L)

23L (4L)

Test Method Vacuum Test B&D Test Helix Test

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4.7 Sterilization Cycle (bar)

Pressure

2.0 1.0 Start

End

0 Times

-1.0 1 2

3

1-2 pre-heating

2-3 pre-vacuum

3-4 sterilizing

4-5 air-discharging

5-6 drying

6-7 stabilizing

4

5

6 7

1-7 entire duration Table-Types of sterilization cycles Type

Description of intended use The sterilization of all wrapped or non-wrapped, solid, hollow load products type A

B and porous products as represented by the test loads in this standard. The sterilization of products as specified by the manufacturer of the sterilizer including non-wrapped solid products and at least one of the following: porous S products, small porous items, hollow load products type A, hollow load products B, single wrapped products, multiple-layer wrapped products. NOTE 1

The description identifies ranges of products and test loads. Non wrapped sterilized instruments are intended either for immediate use or for non

NOTE 2 sterile storage, transport and application (e.g. to prevent cross infection).

4.8 Internal Printer Internal printer will print sterilization record after the completed cycle. Printer page size: width: 55-56mm, Max diameter: 40mm CAUTION

THE PRINTER PAGE SHOUD NOT BE STORED UNDER SUNLIGHT OR NEAR ANY HEAT SOURCE. STORAGE HUMIDITY CAN NOT BE OVER 70%, STORAGE TEMPERATURE MUST BE BETWEEN 15°C AND 35℃

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Chapter 5 Panel and Functions 5.1 Controlling Panel (pic 5-1)

1

5.1.1 Integrated display

2

v

Display of chamber pressure, unit is: bar

v

Display of chamber temperature, unit is:℃

3

v

Display o f cycle progress.

4

v

Display of alarm/error code, refer to error codes for fault

5

detection.

6 5.1.2 Up

button

pic 5-1 Use the Up button to advance through the menu of cycles. 5.1.3 Down

button

Use the Down button to navigate back through the menu of cycles. 5.1.4

Button

Press this button, to enter into the cycle program choice menu, and then press

or

button to choose the cycle program as you need. 5.1.5

Button

This button is used for confirmation of the start or end of the cycle and removing any program malfunction. After you select a program, press this button to confirm it. Press the button again will start a working cycle. To abort the selected cycle press this button for 5 seconds, the working cycle will stop immediately. When error code is displayed, use this button to stop the alarm and return to the working cycle. 5.1.6

Button

Filling water button, it is used for filling the water to the main water tank automatically. CAUTION

PLEASE CONTACT YOUR DISTRIBUTOR OR AUTHORIZED SERVICE REPRESENTATIVE WHEN AN ERROR CODE IS DISPLAYED.

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