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Universal XactTrace

®

 User Instructions 

12 

Safety Standards 

This device complies with the following electrical safety standards:  

 

IEC 60601-1:Ed. 3.1 - General Requirements for Basic Safety and Essential 
Performance 

 

IEC 60601-1-6:Ed. 3.1 

– Collateral Standard: Usability 

 

EMC Standards 

 

IEC 60601-1-2:Ed. 4.0 - Electromagnetic Disturbances 

– Requirements and 

Tests 

Table 1 

– Electromagnetic Emissions 

Guidance and manufacturer’s declaration –  

electromagnetic emissions

 

The 

Universal XactTrace Belt 

is intended for use in the electromagnetic environment 

specified below. The customer or the user of the equipment should assure that it is used in 
such an environment. 

 

Emissions test 

Compliance 

Electromagnetic environment 

– guidance 

RF emissions 
CISPR 11 

Group 1 

The 

Universal XactTrace Belt 

uses RF energy 

only for its internal function. Therefore, its RF 
emissions are very low and are not likely to cause 
any interference in nearby electronic equipment. 

RF emissions 
CISPR 11 

Class B 

The Universal XactTrace Belt is suitable for use in 
all establishments other than domestic, and may 
be used in domestic establishments and those 
directly connected to the public low-voltage power 
supply network that supplies buildings used for 
domestic purposes. 

Harmonic 
emissions IEC 
61000-3-2 

Not Applicable  

Voltage 
fluctuations/ flicker 
emissions 
IEC 61000-3-3 

Not Applicable  

Содержание Universal XactTrace

Страница 1: ...cifications Intended Use The Universal XactTrace system measures respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders The respiratory effort signals...

Страница 2: ...s 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 sa...

Страница 3: ...munity Indicates the Authorized representative in the European Community Swiss Medical Device Ordinance MedDO Swiss Authorized Representative Swiss authorized representati ve Indicates the Authorized...

Страница 4: ...rt 1 General requirements Importer Indicates the entity importing the medical device into the locale ISO 15223 1 Symbol 5 1 9 Symbols to be used with information to be supplied by the manufacturer Par...

Страница 5: ...ty or strength of the source may disrupt the performance of the device For these reasons special precaution regarding electromagnetic compatibility EMC is needed when the device is installed and put i...

Страница 6: ...lengthen the belt 1 Slide the left adjustment buckle toward the center of the belt A loop forms as shown 2 To tighten the loop hold the left end of the belt while pulling the right end Keep the adjus...

Страница 7: ...use two thorax sensors or two abdomen sensors in the same recording Using two sensors of the same type will cause interference between the sensors and could result in poor signal quality 1 Connect a...

Страница 8: ...ery operated sensor turns on when snapped to both ends of the belt When the sensor turns on the lights located on the front side of the belt lock illuminate for a few seconds to indicate the battery s...

Страница 9: ...ctrical and Electronic Equipment WEEE the WEEE may not be disposed of as unsorted municipal waste Return the WEEE Universal XactTrace sensor to the Embla European Representative see last page for cont...

Страница 10: ...o 41 C 40 F to 106 F Storage 18 C to 48 C 0 F to 120 F Relative Humidity Operation 15 95 non condensing Storage 10 95 non condensing Pressure Withstands atmospheric pressures from 0 5 1 06 bar Output...

Страница 11: ...g Snaps Nickel coated spring steel Nickel is non touchable during the intended use Over molding Thermoplastic elastomers TPE Safety Standards Conformity Description Properties Classification Type Inte...

Страница 12: ...user of the equipment should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Universal XactTrace Belt us...

Страница 13: ...M at 1 kHz Proximity Fields from RF Wireless Communications Equipment IEC 61000 4 3 See Enclosure Port Immunity to RF Wireless Communications Equipment Table below Rated Power Frequency Magnetic Field...

Страница 14: ...RS 460 FM 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz...

Страница 15: ...Under no circumstances shall Embla or our distributors be liable for any loss of revenues or damage direct consequential or incidental including loss of profit property damage or personal injury aris...

Страница 16: ...resentations or warranties of any kind whatsoever with respect to this document Natus Medical Incorporated disclaims all liabilities for loss or damage arising out of the possession sale or use of thi...

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