background image

Autoclave Vitale Plus

 

Cristófoli Equipamentos de Biossegurança Ltda., established at Rodovia BR-158, nº 127, Jardim Curitiba in Campo 

Mourão, Paraná, Brasil, manufactures biosafety equipment to assist the health field having as policy: “Develop innovative 
solutions for the health field by using agile, robust and objective processes to better serve its clients. Fulfill the requirements 
for regulatory purposes of the applicable standards, promote the continuous improvement of its quality and environmental 
systems, prevent pollution, reduce its environmental impacts and continuous training of its employees, achieving this way, a 
sustainable profitability and the maximization of the company’s value”. Rev. 2.

 

Develop innovative solutions to protect life and promote health.

Cristófoli, Brazilian company importer and manufacturer of health 

products certified by ISO 9001 - Quality Management System, 

 ISO 13485 - Medical Devices - Quality Management System -

Requirements for Regulatory Purposes, ISO 14001-Environmental 

Management and *BPF - Boas Práticas de Fabricação - ANVISA.

CRISTÓFOLI’S MISSION

CRISTÓFOLI QUALITY AND ENVIRONMENTAL POLICY

*BPF - Boas Práticas de Fabricação: Brazilian standard similar to the GMP - Good Manufacturing Practices (FDA / US).

13485

 DE

S

 G

A

E

M

S

E

T

T

Ã

S

O

I

S

Содержание Vitale Plus 12

Страница 1: ...uce its environmental impacts and continuous training of its employees achieving this way a sustainable profitability and the maximization of the company s value Rev 2 Develop innovative solutions to...

Страница 2: ......

Страница 3: ...rist foli s Biosafety Consultant who provides a valuable assistance in the coordination of Crist foli s Biosafety Project complementary products research training of our employees representatives and...

Страница 4: ...ymbols Introduction Important Safety Information Installation Instructions Autoclave Components Identification Safety Devices Cycles and Messages Safety Notes How to Use the Autoclave Vitale Plus Alti...

Страница 5: ...nding Protection Terminal Fusible Autoclavable Date of manufacture Boas Pr ticas de Fabrica o 4 P B F LOT SN Fragile Handle with care Dangerous Electrical Tension Serial Number Batch code Keep away fr...

Страница 6: ...ation we recommend extra attention to this manual Autoclave sterilization although quicker and more efficient requires totally different procedures and handling while still keeping a simple operation...

Страница 7: ...y kind of use of this equipment other than the ones described in this manual SPECIAL MEASURES AND OBSERVATIONS DURING THE USE OF THE AUTOCLAVE Always make sure the door handle is properly locked befor...

Страница 8: ...he use of an exclusive circuit breaker for the outlet where you intend to install your autoclave If after following all the specifications the electrical current is still oscillating contact your loca...

Страница 9: ...of the external steam exit 8 Fig 1A Fig 3 WATER V CUT DO NOT USE THE LID KEEP THE HOSE ABOVE THE WATER LEVEL 5 liters 1 3 gallons Table 2 X NEVER CUT THE CENTRAL PIN OFF Fig 1 EXTERNAL STEAM EXIT VSPF...

Страница 10: ...use interference in the cycle EXTERNAL STEAM EXIT Located in the back part of the autoclave Fig 1 page 8 it has a diameter of 5 16 for the connection of the discharge hose which is then connected to t...

Страница 11: ...7 Door Gasket Fig 5 Display Start Key Mode Key Cancel Key Lid Panel Keyboard Handle Fig 4 CRIST FOLI A U T O C L A V E S I N S T R U C T I O N M A N U A L Fig 8 Fig 10 Fig 9 250 ml 50 ml 200 ml 150 m...

Страница 12: ...onents Identification Figs 6 and 7 page 10 VSPF VALVE Valve that works as an anti vacuum system patent pending FUSE Safety device which purpose is to protect the building electrical wiring against pea...

Страница 13: ...an no perform cleaning see manual perform biological test cooling 00 00 T 000 C p 0 00 cooling 00 00 cooling T 000 C power outage subpressure detected cancelled by user overpressure detected temp x pr...

Страница 14: ...ymbol 14 appears in some places on the autoclave This means those items require special attention and that the user must observe their references in the Instruction Manual provided with the equipment...

Страница 15: ...re for the new cycle is reached the autoclave will resume operation showing heating up When the solenoid valve shuts down the display will show the temperature and pressure rising gradually When the a...

Страница 16: ...the CANCEL key to return to the program selection mode ATTENTION Even after the beeps that indicate the conclusion of the cycle the contents of the chamber will still be hot Never touch the internal...

Страница 17: ...me ALTITUDE CALIBRATION In order for the autoclave to work properly it is necessary to perform the altitude calibration procedure Calibrate the altitude of the autoclave as shown below for this proced...

Страница 18: ...valve closed this will prevent the liquid from boiling over inside the containers when the liquids sterilization cycle was selected If the operator needs to interrupt cancel the heating sterilization...

Страница 19: ...ature of drained water Total heat in joules transmitted in one hour Proper working temperature range Proper working altitude 12 liters Aluminum 19 4 kg including components Stainless steel 21 2 kg inc...

Страница 20: ...eplace the air filter of the VSPF valve monthly Replace the thermal paste of the heating element annually The component lid Item 2 page 9 must be replaced each 10 years Replace the internal hoses annu...

Страница 21: ...hamber Preventive cleaning stainless steel chamber Door gasket cleaning Door gasket replacement Preventive Maintenance of the VSPF valve and replacement of the internal safety valve Air filter replace...

Страница 22: ...pose of the label located in the back of the equipment is to identify the autoclave technical data ATTENTION The removal of the identification label and or any other labels stickers affixed to the pro...

Страница 23: ...on See How to Proceed when Service is Needed Page 24 THE AUTOCLAVE DOES NOT SWITCH ON POSSIBLE CAUSES SOLUTION The operator connected the autoclave to the power source but didn t press the Start key N...

Страница 24: ...g the sterilization of 26 envelopes at a time 10 x 23 cm containing 6 instruments each Remember to leave some space between the envelopes to allow good steam circulation and optimize drying THE AUTOCL...

Страница 25: ...ive Maintenance Item 7 Page 19 Crist foli Equipamentos de Biosseguran a Ltda makes clear its concern already demonstrated by the implementation of the Environmental Management System according to stan...

Страница 26: ...rcuits fire etc Damage caused by humidity excessive exposure to sun light and salinity Sinister theft or robbery Improper use installation of the equipment and or plugging it into an incorrect voltage...

Отзывы: