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Universal XactTrace

User Instructions

Belt

Sensor

Bipolar Cable

Adjusting the Belt Size

Adjust the belt by sliding the adjustment buckles together or apart to fit a patient
circumference of 65

–200 cm (26–78 in).

To 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 adjustment buckles in a central position with equal distance
between the belt ends and adjustment buckles.

Note:

Avoid sliding the adjustment buckles to the same end of the

belt. This will make readjustment more difficult.

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...