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User Manual 

 

Xltek EMU40EX Battery Pack

 

 

13 

Symbol 

Standard 

Reference 

Standard Title 

Symbol Title 

Explanation 

 

IEC 60601-1 
Table D.2 #10 

Medical electrical 
equipment 

— Part 1: 

General requirements 
for basic safety and 
essential performance 

Follow instructions for 
use 

Refer to instruction manual/ 
Booklet. 
 
NOTE on ME EQUIPMENT 
"Follow instructions for use” 

 

ISO 15223-1 
Symbol 5.4.4 

Medical devices 

— 

Symbols to be used with 
medical device labels, 
labelling and information 
to be supplied 

Caution 

Indicates the need for the user to 
consult the instructions for use for 
important cautionary information 
such as warnings and precautions 
that cannot, for a variety of 
reasons, be presented on the 
medical device itself. 

IEC 60601-1 
Table D.1 #10 

Medical electrical 
equipment 

— Part 1: 

General requirements 
for basic safety and 
essential performance 

 

IEC 60601-1 
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 
operator. 

 

MDR 
2017/745  

EU Medical Device 
Regulation 

CE marking 

Signifies European technical 
conformity. 

 

ISO 15223-1 
Symbol 5.3.7 

Medical devices 

— 

Symbols to be used with 
medical device labels, 
labelling and information 
to be supplied 

Temperature limit 

Indicates the (storage) 
temperature limits to which the 
medical device can be safely 
exposed. 

 

ISO 15223-1 
Symbol 5.3.8 

Medical devices 

— 

Symbols to be used with 
medical device labels, 
labelling and information 
to be supplied 

Humidity limitation 

Indicates the range of (storage) 
humidity to which the medical 
device can be safely exposed.

 

 

ISO 15223-1 
Symbol 5.3.9 
 

Medical devices 

— 

Symbols to be used with 
medical device labels, 
labelling and information 
to be supplied 

Atmospheric pressure 
limitation 

Indicates the acceptable upper 
and lower limits of atmospheric 
pressure for transport and storage. 

 

Содержание Xltek EMU40EX

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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