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BT-410F and BT-410A Operation manual

 

P/N:410-ENG-OPM-EUR-R12 

Bistos Co.,Ltd. 

2021,05 

0 Safety information

 

Before  using  BT-410F  and  BT-410A,  read  this  entire  manual  and  be  fully  understood  the  following  safety 
information to prevent injury of patient and user. 
Observe all precautions to ensure the safety of the patient and those near the instrument. 
 

0.1 Symbols used 

The  following  symbols  identify  all  instructions  that  are  important  to  safety.  Failure  to  follow  these 
instructions can lead to injury or damage to the device. When used in conjunction with the following words, 
the symbols indicate: 

WARNING 

Identifies  conditions  or  practices  that  might  present  danger  or  possible  injury  to  the 
patient and/or user. 

CAUTION 

An instruction that, if not followed, can result in a condition that could damage the light. 

NOTE 

Background information provided to clarify a particular step or procedure. 

The following symbols are placed on product, label, packaging and this manual in order to stand for the 
information about: 

 

Stand-by 

 

 

Those symbols identify safety information.   
Warning and caution necessarily well-know when operating the device or control 
in order to avoid undesirable consequences. 

 

Indicates the manufacturer. 

 

Indicates the production date. 

 

Serial number 

 

Authorized representative in the European Community 

 

Refer to Operation Manual 

 

Indicates the temperature limitation for transport and storage. 

 

Humidity limitation for transport and storage. 

 

Keep dry. Transport package shall be kept away from rain. 

 

Fragile, handle with care 

 

Indicate correct upright position on the transport package. 

 

Indicate  that  the  product  contains  the  recyclable  parts  depending  on  whether 
there  is a  collection mechanism  within the  local  community  for  those  particular 
materials. 

 

The  product  conforms  to  European  Medical  Directive  93/42/EEC  as  amended  by 
2007/47/EC and meets applicable health, safety and environmental requirements. 

 
0.1.1 Symbols on the power adapter 

 

Polarity of DC power connector / DC Adaptor 

 

This symbol indicates that the power adaptor is a class II device. 

Summary of Contents for BT-410A

Page 1: ...BT 410F and BT 410A Head worn light Operation Manual Keep this manual for future reference P N 410 ENG OPM EUR R12...

Page 2: ...e However no responsibility is assumed by Bistos Corporation For its use or any infringements of patents or other rights of third parties that may result from its use No license is granted by implicat...

Page 3: ...7 2 1 Product outlook and description 7 2 2 Loupe optional assembly 8 2 3 Astral lamp optional assemble 9 3 Operation 9 3 1 Adjust the headband 9 3 2 Turn on the power 9 3 3 Focusing the light 9 3 4...

Page 4: ...n product label packaging and this manual in order to stand for the information about Stand by Those symbols identify safety information Warning and caution necessarily well know when operating the de...

Page 5: ...old environment to a warm humid location Do not attempt to service the BT 410F and BT 410A Only qualified service personnel should attempt any needed internal servicing 0 3 Battery warnings WARNING Do...

Page 6: ...rief Device Description Product Features Model Configurations 1 2 Brief device description This Head worn light is used for medical examination by fixing it on the head and illuminating with condensed...

Page 7: ...0A has Fixed Focus lens but BT 410F has Variable focus lens BT 410F and BT 410A system consists of the following function and elements Model BT 410F BT 410A Control of Light Intensity X O Control of L...

Page 8: ...ration 2 1 Product outlook and description Fig 2 1 BT 410A outlook and description Headband height adjustable part Headband part Headband size adjustable part Protect band Power On Off button LED indi...

Page 9: ...e shown below Fig 2 3 Loupe Assembly 2 3 Astral lamp optional BT 410A only assembly The astral lamp can be assembled at the bottom of light source Remove the lens cap from the light source and connect...

Page 10: ...e high charging voltage may cause the device malfunction 3 3 Focusing the light BT 410F only You can adjust the focal length between 25 30 cm Adjust the focus for the best light quality before treatme...

Page 11: ...r is unseparated When charging unseparated be sure the device turned off To separate or assemble the battery pack refer below Fig 3 1 Battery pack assembly method Fig 3 2 Battery pack separation metho...

Page 12: ...s during surgery or other cases 4 Maintenance and cleaning 4 1 Checking the light intensity It is recommended that the intensity of the light be checked before each use and at least every six months W...

Page 13: ...h device or you have further questions please contact Bistos customer center 6 Specifications The BT 410F and BT 410A head worn light is classified as follows in accordance with EN IEC 60601 1 Categor...

Page 14: ...ons flicker emissions IEC61000 3 3 Complies WARNING The BT 410F and BT 410A should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the device should be...

Page 15: ...equency magnetic fields should be at levels characteristic of a typical commercial or hospital environment Conducted RF IEC61000 4 6 3 Vrms 150 kHz to 80 MHz 6 Vrms in ISM bands between 0 15 MHz and 8...

Page 16: ...d with the following symbol IEC 60417 Ref no 5140 Non ionizing electromagnetic radiation Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all si...

Page 17: ...t is manufactured and passed through strict quality control and inspection Compensation standard concerning repair replacement refund of the product complies with Framework Act on Consumers noticed by...

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