Cristofoli vitale 12 Скачать руководство пользователя страница 1

CRISTÓFOLI’S MISSION

CRISTÓFOLI QUALITY AND ENVIRONMENTAL POLICY

 

To develop innovative solutions to protect life and promote health.

    Cristófoli Equipamentos de Biossegurança Ltda., established at Rodovia BR-158, nº 127, Jardim Bandeirantes in Campo 
Mourão, Paraná, Brazil, manufactures biosafety equipment to assist the health care, having the following policy: "To develop 
innovative solutions for health care by using agile, robust, and objective processes to better serve its customers. To fulfill all 
the requirements of the applicable standards, promote the continuous improvement of its quality and environmental 
standards,  prevent  pollution,  reduce  its  environmental  impact,  and  continuously  train  its  staff,  achieving,  therefore,  a 
sustainable and profitable maximization of its value." Rev. 2.

*BPF: Brazilian standard similar to GMP - Good Manufacturing Practices (FDA / US)

Vitale Class 12/21 Autoclave 

13485

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Cristófoli,  Brazilian  importing  company  and  manufacturer  of  health  products
certified  by  ISO  13485  -  Health  Products  -  Quality  Management  System  - 
Requirements for Regulatory Purposes and compliance with RDC 16/2013 - *BPF - 
Boas Práticas de Fabricação - ANVISA requirements.

Содержание vitale 12

Страница 1: ...ll the requirements of the applicable standards promote the continuous improvement of its quality and environmental standards prevent pollution reduce its environmental impact and continuously train its staff achieving therefore a sustainable and profitable maximization of its value Rev 2 BPF Brazilian standard similar to GMP Good Manufacturing Practices FDA US Vitale Class 12 21 Autoclave 13485 D...

Страница 2: ...clave Failure Indications Performing a New Initial Cycle Technical Data Quality Control Preventive Maintenance Monitoring Troubleshooting How To Proceed When Service Is Needed Guidance for Final Disposal of the Equipment Warranty Terms Use Instructions Quick Guide 03 04 04 04 05 06 07 08 08 10 11 11 12 12 13 14 14 15 16 Manual Vitale Class Ingl Rev 4 2018 INDEX CRISTÓFOLI A U T O C L A V E S U S E...

Страница 3: ...of Manufacture Boas Práticas de Fabricação 4 P B F LOT SN Fragile handle with care Dangerous Electrical Tension Serial Number Lot number Keep out of Sunlight Recyclable Keep Dry ISO 13485 13485 DE S G A E M S E T T Ã S I O S Antimicrobial Painting 135 ºC BPF Brazilian standard similar to GMP Good Manufacturing Practices FDA US CRISTÓFOLI A U T O C L A V E S U S E R M A N U A L ...

Страница 4: ...alve opening closing deaerating and depressurizing These processes are part of the proper functioning of the equipment Cristófoli is not responsible for accidents that might occur due to the jolts caused by the noises produced by the autoclave When the handle to open the door the operator must do it easily Never use too much force pulling for it may damage the equipment s internal mechanisms It is...

Страница 5: ...NSTRUÇÕES PRESSÃO MÁXIMA DE OPERAÇÃO CAPACIDADE CONFORMIDADE NORMA NBR 11817 Fig 1 5 liters FUSE HOLDER HOW TO IDENTIFY YOUR AUTOCLAVE The Identification label removal will cause automatic loss of warranty STERILIZATION CHAMBER BASE COVER TEMPERATURE SENSOR INTERNAL STEAM EXITS DOOR Panel Lid set LID DOOR GASKET HANDLE TRAY HOLDER TRAYS SAFETY VALVE ANTI VACCUUM PANEL HANDLE KEYBOARD IDENTIFICATIO...

Страница 6: ...m table below Table 1 AUTOCLAVE CIRCUIT BREAKER VOLTAGE Vitale Class 12 Vitale Class 21 WIRING GAUGE Fordistancesupto5m 16ft fromthecircuitbreakertotheoutletusedto connecttheequipment use2 5mmwiring From5to15m 16to46ft use4mm andfrom15to50m 46to164ft use6mm NOTE Forthe21 litersmodel 127V fordistancesupto15to35m 49to114ft use6mm wiring and 8mmfor114to164ftdistance 8 A 127 220 V 12 A NOMINAL CURRENT...

Страница 7: ... Vitale Class 21 Close the door and press to begin 2 1 The performance of the autoclave is directly related to the atmospheric pressure which varies according to the altitude of where is it installed The following instructions will guide you on how to perform the Initial Cycle of your autoclave This reinforces that your autoclave will efficiently work at the location where it is installed Fig 6 If...

Страница 8: ...used fuse is the glass 6 35x32 AGLF fast acting If substitution is needed see Troubleshooting page 13 DOOR KEY Internal device that prevents the functioning of the equipment if the door is not properly closed TEMPERATURE VS PRESSURE DATA CROSSING ELECTRONIC SYSTEM Internal system that automatically cancels the cycle if any problem is detected with pressure reading DOOR LOCKING Internal device whic...

Страница 9: ... not exceed 75 of the chamber capacity Place the envelopes always with the paper table 4 side upturned it the steam resulting on a fast and efficient drying and for th s eases penetration process e ame reason boxes and trays must be totally perforated so that allows steam circulation and makes drying easier c d e Press to start the autoclave will beep once and the LED Aquecendo Secando Heating Dry...

Страница 10: ...ter that the heating drying LED will blink with 2 beeps every 4 seconds indicating the need to slightly open the door for a proper drying figures 10 and 11 ATTENTION When opening the autoclave for drying see the correct position of the door figures 10 and 11 Keep the handle all the way down fig 11 Vitale Class performs drying with open door It is usual that in this moment some steam comes out thro...

Страница 11: ...ze 28 5 mm approximate value 127 220V AC 95 254 V 50 60 Hz 1600 Watts 485 Watts hour 2 216 kPa 2 2 kgf cm 100ºC 15ºC a 40ºC Up to 3500 m 10363350017 12 liters 17 7 kg 19 4 kg Stainless Steel 22 x 30 cm 35 x 34 5 x 48 5 cm 15 5 x 1 2 x 28 cm small 20 x 1 2 x 28 cm large 67 mm approximate value 127 220V AC 95 254 V 50 60 Hz 1200 Watts 336 Watts hour 2 216 kPa 2 2 kgf cm 100ºC 15ºC a 40ºC Up to 3500 ...

Страница 12: ...nitorização Física e Química on www youtube com CC available Door gasket cleaning Remove the gasket by pulling it after that clean it with a cloth which does not shed moistened with water and place it on the lid again Sterilizing monitoring biological test Peform biological test every 7 days To obtain more information about how to perform the chemical tests consult www cristofoli com at the sessio...

Страница 13: ...ed to the outlet The key was not pressed to turn the autoclave on Blown fuse Verify if there s a power failure in your area Connect the power cord to the outlet properly Press Replace the fuse that is located near to the power chord unplug the autoclave remove the cover of the fuse holder take out the damaged fuse put the new one replace the cover and turn on the equipment THE AUTOCLAVE PRESSURE G...

Страница 14: ...possible to determine how long is it as it varies according to the intensity and how the equipment is used or handled Exception made for the component lid which must be replaced every 10 years CRISTÓFOLI EQUIPAMENTOS DE BIOSSEGURANÇA LTDA makes clear its concern already demonstrated by the implementation of the Environmental Management System according to standard NBR ISO 14001 2004 and strongly r...

Страница 15: ...y the buyer owner The warranty will be voided in cases of Problems arising from natural causes such as floods lightning etc Use of non distilled water for the operation of the autoclave Damage caused by accidents such as dents drops short circuits fire etc Damage caused by humidity excessive exposure to sun light and salinity Sinister theft or robbery Improper use installation of the equipment and...

Страница 16: ... the end of the process the LED will be on Wait until the temperature of the material decreases to handle it 16 USE INSTRUCTIONS QUICK GUIDE Read carefully the Instruction Manual TIEMPO DE SECADO For altitudes above 2 000 m the sterilization time is 20 minutes Maximum drying temperature 129 C Default Program Extra Drying PROGRAMS STERILIZATION TEMPERATURE STERILIZATION PRESSURE STERILIZATION TIME ...

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