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Xltek EMU40EX Battery Pack 

 

User Manual

 

 

 

 

12 

GLOSSARY OF SYMBOLS 

Symbol 

Standard 

Reference 

Standard Title 

Symbol Title 

Explanation 

 

Not applicable  Not applicable 

An indication of 
Medical Device 

This product is a medical device. 

 

21 CFR Part 
801.109(b)(1) 

Labeling-Prescription 
devices 

Prescription only 

Indicates that the product is 
authorized for sale by or on the 
order of a licensed healthcare 
practitioner. 

 

ISO 15223-1 
Symbol 5.4.5 
(Reference 
Annex B for 
the general 
prohibition 
symbol) 

Medical devices 

— 

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

Not made with natural 
rubber latex 

Indicates that the medical device is 
not made with natural rubber latex. 

 

2012/19/EU 

Waste Electrical and 
Electronic Equipment 
(WEEE) 

Disposal at end of 
operating life 
instructions 

Indicates that electrical and 
electronic equipment waste should 
not be discarded together with 
unseparated waste but must be 
collected separately. 

 

ISO 15223-1 
Symbol 5.1.1 

Medical devices 

— 

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

Authorized 
representative in the 
European Community 

Indicates the Authorized 
representative in the European 
Community. 

 

ISO 15223-1 
Symbol 5.1.3 

Medical devices 

— 

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

Date of manufacture 

Indicates the date when the 
medical device was manufactured. 

 

ISO 15223-1 
Symbol 5.1.6 

Medical devices 

— 

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

Catalogue number 

Indicates the manufacturer’s 
catalogue number so that the 
medical device can be identified. 

 

ISO 15223-1 
Symbol 5.1.7 

Medical devices 

— 

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

Serial number 

Indicates the manufacturer's serial 
number so that a specific medical 
device can be identified. 

 

ISO 15223-1 
Symbol 5.4.3 
Annex A 
#A.15 

Medical devices 

— 

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

Consult instructions for 
use 

Indicates an instruction to consult 
an electronic instructions for use 
(eIFU). 

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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