natus Universal XactTrace User Instructions Download Page 8

Universal XactTrace

®

 User Instructions 

patient's chest. If a green light illuminates for a few seconds, the battery is 
sufficiently charged. 

5.  Using the adjustment buckles, adjust the belts so they fit the patient snugly. 
6.  Connect the cables to the appropriate inputs on the recording device. Plug 

the red and black connectors into the positive (+) and negative (-) inputs, 
respectively. 

 

Proper placement of the Universal XactTrace system 

Battery Status 

The battery-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 status. 

 

Green light.

 The battery is sufficiently charged. 

 

Yellow light.

 The battery charge is low and will be depleted in less than 10 

studies. 

 

No light.

 Replace the sensor before performing a study. 

 

Note:

 The battery cannot be replaced. Disconnect the sensor from 

the belt before storing the system.  

Storage 

Proper storage extends the life of the Universal XactTrace system. To prevent 
damage, do the following when storing the belts and cables between studies. 

Summary of Contents for Universal XactTrace

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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