background image

 

 

 

Declaration of conformity 
Déclaration de conformité 
Dichiarazione di conformità 

FATech Diagnostics Italia, Srl 

declare under our sole responsibility that the product, 
déclarons sous notre seule responsabilité que le produit, 
dichiariamo sotto nostra unica responsabilità, che il prodotto, 

VEGA MB-97  Cassette Printer,

 

to which this declaration relates is in conformity with the following standard(s) or other normative 

documents. 
auquel se réfère cette déclaration est conforme à la (aux) norme(s) ou au(x) document(s) 

normatif(s). 
a cui si riferisce questa dichiarazione è conforme alla/e seguente/i norma/e documento/i normativa/

e

 

Instrument Compliance 

FATech Diagnostics Italia herby declares the equipment specified conforms to the Classification(s), 

Directive(s) and Standard(s) set forth in this document. 

FATech Diagnostics Italia produces laser systems within one of two classes as identified and classi-

fied by theCDRH. These are Class I and Class IV. (see CDRH 21 CFR (J) 1040.1 - 1040 .5). End 

user of the equipment should be familiar with ANSI, CDRH and OSHA standards for radiation emit-

ting devices as they apply to them also. 

Certifications: 

- [Saf] IEC 61010-2-101:2015  

- [Saf] IEC 61010-1:2010  

-

[EMC] EN 61326-1:2012  

-

[EMC] EN 61000-3-2:2019 

-

[EMC] EN 61000-3-3:20 

-

FCC CFR 47 Part 15 Subpart B and ICES-003 Issue 7 

Page    of  

6

26

Declaration of Conformity

Summary of Contents for VEGA MB-97

Page 1: ...US Version Page of 1 26 VEGA MB 97 Operator s Manual...

Page 2: ...text onto VEGA MB 97 Cassettes hence reducing errors due to misidentification of cassette blocks or specimen slides caused by illegible handwriting The VEGA MB 97 Cassette Printer comes equipped with...

Page 3: ...te click on HUB and you will get a new screen Modify cassette maga zine 13 Section 4 Creating a new User 15 Generate a copy of the parameter list 16 Data Export 16 Section 5 Troubleshoot cassette jam...

Page 4: ...nts Never attempt to dismantle or repair the laser head In case of malfunction con tact a FATech Diagnostics Italia Service representative Any of the actions mentioned above may result in permanent ey...

Page 5: ...de any of the safety interlocks on the instruments Apart from a class 4 laser the instrument contains moving machinery that may cause damage to the user if the above advices are not followed Changes o...

Page 6: ...rme alla e seguente i norma e documento i normativa e Instrument Compliance FATech Diagnostics Italia herby declares the equipment specified conforms to the Classification s Directive s and Standard s...

Page 7: ...grid Laser Label Cooling Fan grid USB Port Interlock Key ON OFF Switch Power supply socket Organizer connector Remote Interlock USB Interlock Key ON OFF Switch Remote Interlock Power supply sock Orga...

Page 8: ...LED Indicators Page of 8 26 Cassette hoppers Spare hoppers carousel Cassette dispensing chute LED Indicator label...

Page 9: ...ses 120V 4 Amp 240V 3 Amp Max dBA Sound level 55dBA Max Power 70W Over Voltage Category II Index Protection IP55 Hubs 6 Cassette Capacity 80 Cassettes per Hub 480 Cassettes total Print Speed Up to 12...

Page 10: ...of the cover When the system will be ready the emergency button will turn RED Launching VEGA Software 1 Double click the VEGA icon 2 Enter User Name and Password Default values administrator administ...

Page 11: ...ady to receive information to mark cassettes When the box is red COMMUNICATION ERROR is dis played there is a communication problem and the system requires technical assistance An Error code will also...

Page 12: ...point the user can load the three maga zines facing forward To access the other three 3 magazines press the LOAD button a second time This will rotate the magazine HUB 180 Once cassette loading is com...

Page 13: ...ect Print Prioritizing Cassettes When a cassette of any type is required with priority Ex Reprint Extra cassette it is possible to either press the function Priority or send a command through the LIS...

Page 14: ...Page of 14 26...

Page 15: ...le to return to the main UI 1 Click on New 2 Select User Type a Click on the down arrow Select either Administrator Power User or User 3 Curser to the User Name Enter the name of the new user 4 Next c...

Page 16: ...Pa rameter Select the printer icon This will automatically generate in C the file VEGA parameters Data Export It is possible to define an interval of time in the Archive and print all cases The folder...

Page 17: ...id Inspect the cassette tray and if present remove the piece that got stuck After solving the problem put the lid back put the hooper carousel in its original position and press the side button Emerge...

Page 18: ...ible to manually remove it and replace it with an empty one A sensor positioned at the back of the Sorter verifies the presence of any residual cassette The user can always command the manual frontal...

Page 19: ...ws With a brush remove any dust residual that might have deposited on the chute Replace the lid and the carousel Power ON the unit and press the Emergency button that will turn RED Power on the PC Dou...

Page 20: ...ers and laser systems are ex empt from all control measures The Class 1 designation does not apply during times of mainte nance or service where the safety controls of the device are defeated or other...

Page 21: ...mal Injury The most common cause of laser induced tissue damage is thermal in nature where the tissue proteins are denatured due to the temperature rise following absorption of laser energy The ther m...

Page 22: ...ting No requirement No requirement Should have Shall have Nomi nal Hazard Zone Analysis Required Shall have Nomi nal Hazard Zone Analysis Required Standard Operat ing Procedures No requirement No requ...

Page 23: ...ional buyers to the final user of the WEEE always under the Buyer s responsibility Noncompliance by the Buyer with the above mentioned obligations may lead to the application of criminal sanctions as...

Page 24: ...nerate eye injury WARNING FOR USERS DIODE Lifespan The component emitting light LED Light Emitting Diode is normally subject to degrade over time On heavy workload conditions the DIODE can have a fast...

Page 25: ...itions 1 This device may not cause harmful interference an d 2 This device must accept any interference received including interference that may cause undesired operation Product names NOVA ENB 91 VEG...

Page 26: ...ion however they are subject to change without notification All trademarks and registered trademarks are property of FATech Diagnostics Europe Duiven The Nederlands FATech Diagnostics Europe BVl t Hol...

Reviews: