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Xltek EMU40EX Battery Pack 

 

User Manual

 

 

 

 

10 

COMPLIANCE STANDARDS 

 

ISO 10993-1: 2018 Biological evaluation of medical devices 

— Part 1: Evaluation and testing within a 

risk management process 

 

EN ETSI 300 019-2-1 Environmental Engineering (EE); Environmental conditions and environmental 
tests for telecommunications equipment; Part 2-1: Specification of environmental tests; Storage 

 

EN ETSI 300 019-2-2 Environmental Engineering (EE); Environmental conditions and environmental 
tests for telecommunications equipment; Part 2-2: Specification of environmental tests; Transportation 

 

ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems for 
Vibration 

 

UL1642 and IEC 62133-2:2017 Standard for Safety for Lithium Batteries 

 

IEC  60601-1:2005+A1:2012  Medical  electrical  equipment  -  Part  1:  General  requirements  for  basic 
safety and essential performance 

 

IEC 60601-1-2 Fourth Edition Medical electrical equipment - Part 1-2: General requirements for basic 
safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements 
and tests 

DISPOSAL INSTRUCTIONS 

Natus is committed to meeting the requirements of the European Union WEEE (Waste Electrical and 
Electronic Equipment) Regulations 2014. These regulations state that electrical and electronic waste 
must be separately collected for the proper treatment and recovery to ensure that WEEE is reused or 
recycled safely. In line with that commitment Natus may pass along the obligation for take back and 
recycling to the end user, unless other arrangements have been made. Please contact us for details on 
the collection and recovery systems available to you in your region a

natus.com

 

Electrical and electronic equipment (EEE) contains materials, components and substances that may be 
hazardous and present a risk to human health and the environment when WEEE is not handled correctly. 
Therefore, end users also have a role to play in ensuring that WEEE is reused and recycled safely. Users 
of electrical and electronic equipment must not discard WEEE together with other wastes. Users must use 
the municipal collection schemes or the producer/importers take-back obligation or licensed waste 
carriers to reduce adverse environmental impacts in connection with disposal of waste electrical and 
electronic equipment and to increase opportunities for reuse, recycling and recovery of waste electrical 
and electronic equipment. 

Equipment marked with the below crossed-out wheeled bin is electrical and electronic equipment. The 
crossed-out wheeled bin symbol indicates that waste electrical and electronic equipment should not be 
discarded together with unseparated waste but must be collected separately.  

 

 

Summary of Contents for Xltek EMU40EX

Page 1: ...EMU40EX Battery Pack User Manual...

Page 2: ...or in part except with the prior written permission of Natus Neurology Incorporated The copyright and the foregoing restrictions on the copyright use extend to all media in which this information is p...

Page 3: ...D USERS AND PATIENT TARGET GROUP 7 CLINICAL BENEFITS 7 CONTRAINDICATIONS AND SIDE EFFECTS 7 CHARGING THE BATTERY PACK 7 USING THE EMU40EX HEADBOX WITH THE BATTERY PACK 8 USEFUL TIPS 8 MAINTENANCE 9 SP...

Page 4: ...ording to IEC 529 The Battery Pack is not water proof Prevent detergent solution or cold sterilization agents from seeping into the electronics of the system Battery pack stored by plugging into the c...

Page 5: ...to 50 75 before storage i e charge it for about 2 hours Device dropped or damaged in transit use could lead to loss of function or delayed diagnosis Inspect the device prior to each use and do not use...

Page 6: ...Xltek EMU40EX Battery Pack User Manual 6 Fig 1 Battery Pack Fig 2 USB Power Adapter Fig 3 USB power Cable Fig 4 EMU40EX Power Cable...

Page 7: ...The EMU40EX batter pack extends the period that a patient may be in an ambulatory position or not physically connected to an amplifier base through a cable to facilitate the continuous recording of a...

Page 8: ...u do not intend to use the Battery Pack for a long time When the EMU40EX Power Cable is unplugged the Battery Pack automatically enters low power standby mode prolonging battery life All lithium batte...

Page 9: ...acity 2500 2700mAh Energy capacity 9 8Watt hours Input charging voltage 5 12VDC Charging current limited to 500 1000mA 4 2V Charging time 3 hrs Charge retention storage 80 at Humidity 65 20RH 20 to 20...

Page 10: ...ons state that electrical and electronic waste must be separately collected for the proper treatment and recovery to ensure that WEEE is reused or recycled safely In line with that commitment Natus ma...

Page 11: ...State in which the user and or patient is established Refer to the Natus website for an electronic copy of this document INSTRUCTIONS TO ACCESS THE eIFU A copy of the Instructions for Use in PDF form...

Page 12: ...ation to be supplied Manufacturer Indicates the medical device manufacturer ISO 15223 1 Symbol 5 1 2 Medical devices Symbols to be used with medical device labels labelling and information to be suppl...

Page 13: ...1 Table D 2 2 Medical electrical equipment Part 1 General requirements for basic safety and Essential performance General warning sign Indicates a hazard of potential personal injury to patient or op...

Page 14: ...Website natus com 033980 Rev 1 03 2021 A Total Service Solution Natus Systems are backed by a comprehensive extendable warranty Our support team is available around the clock Our technical staff prov...

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