IVYX Scientific 16L Lab Autoclave Steam Sterilizer Instruction Manual

Steam Sterilizer
Operation Manual
ASS090
REV-D
Operation Documentation

Regulatory Requirement

This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

Revision History

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on manufactory. If you need to know the latest revision, please contact your distributor, sales representative, or our service department.

Conformance Standard
The content of this manual is fit for the sterilizers.
Above sterilizer accords with the requirements of European Class N:
93/ 42/ EEC
97/ 23/ EC
EN 61010 -1
EN 61010 -2 -040
EN 13060
EN 61326 -1

European Authorized Representative
DTF Technology s.r.l.
Address:Piazza velasca 6, 20122 Milano, Italy
Tel: 390284893641
Fax: 39 02 84718594

This equipment complies with the regulatory requirements 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.
Certification
Manufactory is certified with EN ISO 9001 and EN ISO 13485.
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 equipment 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, check appendixes.

Introduction

1.1 Attention
This manual contains necessary and sufficient information to operate equipment safely, such as optimal usage, secure and reliable operation, regular and correct servicing requirements.
Read and understand all instructions in this manual before attempting to operate equipment.
Keep this manual with the equipment at all times. Periodically review the procedures for operation and safety precautions.

1.2 Usage Indication
Application to all wrapped or non-wrapped, solid, hollow load products type A and porous products or related articles.
This sterilizer can be used for dental clinic, laboratory, surgical room, emergency room, ophthalmology, gynecology and steam, cosmetic hospital and so on, by dentists and professionals.
1.3 Contraindication
There is no any contraindication of this equipment.

Safety

2.1 Explanation Symbol
Device Icon Description

“ATTENTION” – Consult accompanying documents, alert the user to refer to the manual or other instructions when complete information cannot be provided on the label.
“ATTENTION” – Pay attention to the high temperature in the chamber, and to the sterilizer exterior when exhausting system is running.
****“PROTRCTIVE EARTH” – Indicates the protective earth (grounding) terminal.
“CAUTION” – Dangerous voltage (the lightning flash with arrowhead), indicates electric shock hazards.

Label Icon Description

| Symbol for
“SERIAL NUMBER”| | Symbol for “MANUFACTURER”
---|---|---|---
| Symbol for
“CATALOGUE
NUMBER”| | Symbol for
“AUTHORISED
REPRESENTATIVE IN
THE EUROPEAN COMMUNITY
| Symbol for
“DATE OF
MANUFACTURE”| | Symbol for
“CAUTION”

Manual Prompt

Note| Indicates that concerning information which easier or helpful in the operation.
---|---
Caution| 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 may exist which through inappropriate conditions or actions will or can cause:
• Severe personal injury;
• Substantial property damage;
• Substantial damage to equipment.

CAUTION
INDICATES PRECAUTIONS OR RECOMMENDATIONS THAT SHOULD BE USED IN THE OPERATION.

2.2 General Safety Recommendation

• The user is responsible for operation and servicing the sterilizer in accordance with the instructions listed in this manual.
• The sterilizer could not be used for liquid.
• The sterilizer has not been designed to operate in the presence of gas or explosive vapors.
• The trays and the load will still be hot at the end of each cycle. Use the tray holder provided to remove each tray from the chamber.
• Do not open the door of the chamber during the sterilization programs. Do not open the door until the pressure inside chamber is getting to 0bar.
• Do not put your hands or face on the cover of the sterilizer during the sterilization programs.
• Do not remove the instruction plate or any label from the sterilizer.
• Do not pour water or any other liquid over the sterilizer.
• Do not fill the caustic matter in the chamber.
• Use only high quality distilled water.
• Unplug the main lead before inspecting or servicing the machine.
• Only an approved technician using original spare parts can carry out repairs and maintenance.
• During the transportation, the sterilizer should be carried by two people in case of turning over.
• Do not use the equipment for cooking.

2.3 Operation Risk
Please take attention on avoid operation risk during operation.

Scald risk

• Every time open the door after finish one cycle, please keep an appropriate distance, because the chamber still have rudimental steam with high temperature, avoid to be scalded.
• Every time open the door after finish one cycle, please not touch the main door and chamber, because of high temperature, avoid to be scalded.

Pollution risk
Please clean the chamber after every time, avoid rudimental contamination left inside chamber.

2.4 Protection Device

scalded.

Receiving and Installation

3.1 Check the Package
Please check package carefully when you receive the equipment.

3.2 Unpacking the Accessory

Open the door and take out all the accessories, item listed below:

3.3 Installation Environment

After remove the package, the sterilizer should be set in a level place which at least has 5 cm distance with each side (20cm of the top) as followed:

• The sterilizer should be set in a place with good ventilation;
• The temperature of environment: 5-40℃;
• The humidity of environment: ≤85%;
• Atmosphere pressure: 860Hpa～1060Hpa;
• An earth connection is essential.

Description and Specification

4.1 Overview

5mins

4.2 Specification

Basic specification
Rated Voltage: AC 220V/ 50~60Hz/ 4A, or AC 110V/ 50~60Hz/ 8A if request.
Rated Power: 1400VA (8A); 1200VA (4A);
Fuse: F12AL AC220V /F25AL AC110V
Operation Temperature: 5～40℃
The Board Affording Weight: 4000 N/m
Noise :< 50db
The Max. Capacity of a plate: 1000g
The Max. Duration of using loading test: 90mins.
The Max. thermal radiation energy under the condition of 20℃~26℃: <2000J.
Sterilizer Chamber
Material: stainless steel 304 (for medical)
Work Pressure: -0.9 bar～2.5 bar
Max. Temperature: 145 ℃
Chamber Volume: 16L (Φ230×3 50mm)
Loading Size: 16L (180×180×280)
Max. Loading Weight: 16L (3.07kg/cm)
Working Pressure/Temperature: 1.1～1.3bar/ 121~122℃; 2.1～2.3bar/ 134~135℃
Water Volume for One Cycle: 0.3L～0.4L2
Sterilizer Steam Safety Valve
Safety Release Pressure: 2.45 bar
Max. Working Temperature: 160 ℃

Panel and Function

5.1. Adjust the both fore pads to ensure that the front part of Autoclave is higher than rear.

5.2. Open the door and make sure that there is no dust or impurity left inside chamber, fill 600-800ml distilled water into the chamber.

CAUTION
MAKE SURE THAT THE WATER SURFACE IS NOT HIGHER THAN THE WATER BOARD OF THE CHAMBER. IT IS NOT ALLOWED TO START THE CYCLE WITHOUT WATER.

5.3. Connect one end of the draining tube to the equipment and put the other end into the waste water tank, then to turn off the air exhausting switch.

5.4. Load the trays into the chamber with tray removal tool, and put the instruments which need to be sterilized on the trays.
5.5. Turn on the power switch, then set the sterilization temperature, temperature select switch
ON: 134℃/ 0.22Mpa/ 6mins, temperature selection OFF:121℃/ 0.12Mpa/ 25mins.

5.6. Close the door. It will start sterilization cycle automatically.
5.7. When the cycle is finished, the green lamp will be kept on. Then please turn on the air exhausting switch to release the pressure inside the chamber to 0 bar, which takes about 6 to 8mins. Then you can open the door.

CAUTION
PLEASE DO NOT OPEN THE DOOR UNTIL THE PRESSURE INSIDE CHAMBER FALLS TO 0 BAR.
5.8. Please turn off the power switch and take the instruments out.

Working Phase and Troubleshooting

equipment
Self-test turns off that air exhausting valve is open| Red light blinks| Stops 1s between every 2 rings exhausting valve| Turn off the air switch, and restart the equipment
Over temperature inside chamber| Red light blinks| Stops ls between every 3 rings| Stop heating and turn off the power
Sterilization temperature is too low| Red and yellow lights blink in turn| Stops is between every 4 rings| Turn off the power and restart the equipment after
cooling
Temperature sensor fails| Red light always on| Stops is between every 5 rings| Turn off the power and restart the equipment after
coding
Close the door improperly| Red light blinks| Stops 1s between every 1 s ring| Close the door properly
Fail to get sterilization temperature in 30mins| Yellow light blinks| Stops ls between every 6 rings| Turn off power to check if the following situations
exist: the heating ring is broken, low voltage, water inside chamber is not enough or loaded too many
instruments
In process of heating or air exhausting| Green light blinks beginning of| Rings 1 time at the working, steam discharging and
sterilizing|
In state of constant
temperature and
pressure| Green light blinks| Rings at the
beginning and
ending of constant
temperature
---|---|---
Sterilization complete
successfully| Green light always on| Stops 1s between
every 3 rings

The yellow light is always on at the temperature of 134℃. But it blinks under the situation of alarming.
Attention : the program can’t start when the door is not closed properly.

Appendix Piping and Circuit Diagram

Piping Diagram

Circuit Diagram

Documents / Resources

| IVYX Scientific 16L Lab Autoclave Steam Sterilizer [pdf] Instruction Manual
16L Lab Autoclave Steam Sterilizer, Lab Autoclave Steam Sterilizer, Autoclave Steam Sterilizer, Steam Sterilizer, Sterilizer
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