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User & Service Manual 

Trex™ HD Monitoring Amplifier 

 

 

 

7

 

2. Safety and Standards Conformity 

2.1. Safety and Standards Conformity for Natus Trex HD Monitoring 

2.1.1.  Standards of Compliance and Normative References  

Electroencephalograph system, model 

Trex HD Monitoring

; rated two AA 1.5V batteries, 0.065A, 

0.170W. 

1.  Type of protection against electric shock: Internally Powered Equipment  

2.  Degree of protection against electric shock: Type BF 

3.  Degree of protection against ingress of water: IPX0 

4.  Mode of operation: Continuous 

5.  Environmental Conditions: Normal: 5-40°C, 15-93% rH, 700-1060hPa  

The essential performance of the Trex HD Monitoring amplifier system is defined in the particular 

standards IEC 60601-2-26 and ISO 80601-2-61. It is EEG equipment that incorporates a pulse oximeter 

without an alarm. 
The 

Trex HD Monitoring 

and its accessories have been designed to comply with the following national 

and international standards. 

Содержание Trex HD

Страница 1: ...Trex HD Monitoring Amplifier User Service Manual...

Страница 2: ...copyright use extend to all media in which this information is preserved This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus Neurology Incorporated or it...

Страница 3: ...arnings 23 4 Procedures and Warnings 24 4 1 Electrostatic Discharge ESD Handling Procedures and Warnings 24 4 2 Conducted Immunity Procedures and Warnings 25 5 Description of Symbols 26 6 Specificatio...

Страница 4: ...2 Battery Power with AA Batteries and External Battery Pack 49 12 Natus External Battery Pack 50 12 1 External Battery Pack Warnings and Cautions 50 12 2 Using the External Battery Pack with the Trex...

Страница 5: ...llow all instructions that are provided with the system WARNING We strongly recommend you read and follow the Safety and Warnings and Cautions section of this manual before operating this amplifier WA...

Страница 6: ...Please follow all instructions carefully NOTE In addition to reading this manual we encourage you to explore the online Help of the software to enable you to take advantage of everything that Natus h...

Страница 7: ...wered Equipment 2 Degree of protection against electric shock Type BF 3 Degree of protection against ingress of water IPX0 4 Mode of operation Continuous 5 Environmental Conditions Normal 5 40 C 15 93...

Страница 8: ...ectrical Equipment Part 1 4 General Requirements for Safety Collateral Standard Programmable Electrical Medical Systems EN ISO 80601 2 61 2011 Edition 1 Medical electrical equipment Part 2 61 Particul...

Страница 9: ...ility EMC Part 4 5 Testing and Measurement Techniques Surge Immunity Test IEC 61000 4 6 2008 EN 61000 4 6 2009 Electromagnetic Compatibility EMC Part 4 6 Testing and Measurement Techniques Immunity to...

Страница 10: ...emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Trex HD Monitoring is suitable for use in all establishments includ...

Страница 11: ...nvironment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25...

Страница 12: ...recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic Site survey3 should be less than the compliance level in each frequency range...

Страница 13: ...aximum output power of transmitter W Separation distance according to the frequency of transmitter m from 150kHz to 80MHz d 1 2 x P from 80MHz to 800MHz d 1 2 x P from 800MHz to 2 5GHz d 2 3 x P 0 01...

Страница 14: ...munications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be...

Страница 15: ...or decreased immunity of the equipment and may cause the system to be non compliant with the requirements of IEC 60601 1 2 Nonin 8000J pulse oximeter sensors used with the Trex HD Monitoring amplifie...

Страница 16: ...ance including electromagnetic immunity see Section 2 1 3 External equipment may interfere with the performance of the Trex HD Monitoring even if that other equipment complies with CISPR Emission requ...

Страница 17: ...he summation of leakage currents when all the parts of the system are interconnected no equipment other than devices connected to the Trex HD Monitoring may be powered by the isolation transformer The...

Страница 18: ...he acquisition computer The Trex HD Monitoring contains FCC ID R47F2M03GL which complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause...

Страница 19: ...ng other medical equipment such as an electrical stimulator simultaneously to the same patient may constitute a safety hazard Do NOT touch any Trex HD Monitoring system accessible metal parts and the...

Страница 20: ...to completely understand the patient s condition Significant levels of dysfunctional hemoglobins HbCO or MetHb may cause inaccurate measurements Intravascular dyes such as indocyanine green or methyle...

Страница 21: ...fier system does NOT include SpO2 or Pulse Rate alarms 3 7 Pulse Oximeter Sensor Warnings Before using carefully read the sensor directions for use Use only Nonin oximetry sensors as required for SpO2...

Страница 22: ...ze by irradiation steam or ethylene oxide See the cleaning instructions in the directions for use for reusable patient cables The oximeter sensor may not work on cold extremities due to reduced circul...

Страница 23: ...a Any abnormal pattern or out of range value is confirmed by trained medical professionals performing the test In addition to ancillary data e g SpO2 the accompanying EEG Electroencephalograph amplifi...

Страница 24: ...help reduce the incidence of component damage caused by static electricity Immediately before handling any product components assemblies drain the electrostatic charge from your body by touching a kno...

Страница 25: ...n the EEG waveforms which are coupled together with off the scale values for auxiliary sensors Follow these techniques to help identify the sources and to increase the immunity towards parasitical noi...

Страница 26: ...that a specific medical device can be identified 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 Ind...

Страница 27: ...n ME EQUIPMENT Follow Instructions for use Rx only 21 CFR 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...

Страница 28: ...rge IEC 60417 Symbol 5031 Graphical symbols for use on equipment Direct current Indicates on the rating plate that the equipment is suitable for direct current only to identify relevant terminals IEC...

Страница 29: ...Alarm inhibit Identifies the alarm inhibit on control equipment IEC 60417 Symbol 5007 Graphical symbols for use on equipment ON power Indicates connection to the mains at least for mains switches or...

Страница 30: ...56 dB Electrode Connections including common input Touchproof 4 Non Isolated DC Inputs 5 Volts Resolution 16 bit A D Impedance kOhm 2 5 5 10 25 Channel Test Signal Software selectable Sampling Frequen...

Страница 31: ...ic Pressure 700 hPa to1060 hPa Transport and Storage Temperature Range 40 C to 70 C Transport and Storage Humidity Range 10 to 100 including condensation Transport and Storage Atmospheric Pressure Ran...

Страница 32: ...Amplifier 1 Power LED 2 Status LED 3 Oximeter Photic Connection 4 Reference Input forward 5 Common Input rear 6 24 Referential Inputs two rows 7 Patient Event Button Connection 8 DC Inputs rear row 9...

Страница 33: ...User Service Manual Trex HD Monitoring Amplifier 33 7 2 Rear View NOTE Dispose of used non rechargeable batteries in accordance with local regulations and manufacturer s instructions...

Страница 34: ...toring Patient Guide Patient Instructions Booklet Diary English Trex HD Sleep Label Natus External Battery Pack Kit Carrying Case NOTE The Trex HD Monitoring is supplied with a standard label displayi...

Страница 35: ...HD Monitoring Headbox 034504 Trex HD Monitoring Carry Case 021995 Trex HD Monitoring Pouch W8190X Mini USB Cable 1 8m 5 9ft W6348H Patient Event Button 0 6m 2ft W6473H Trex HD Cable for LED Photic Sti...

Страница 36: ...stand or sit in front of the computer but not continuously The patient will sleep with the Trex HD Monitoring System and non patient worn accessories on a bedside table and is in no way supported by t...

Страница 37: ...Trex HD insert two new AA batteries while the Trex HD is disconnected from the tablet Next connect the Trex HD Monitoring headbox to the tablet via USB 9 1 3 1 Start an ambulatory monitoring study Th...

Страница 38: ...ng to internal memory Connect a fully charged battery pack to the Trex HD optional Review the Patient Guide p n 019691 with the patient 9 1 3 2 Monitor an ambulatory study To initiate monitoring after...

Страница 39: ...HD Monitoring may be disconnected from the computer after upload is complete up to 6 min for a 24 hour study NOTE If the Natus external battery pack p n 019822 is connected to the Trex HD Monitoring h...

Страница 40: ...h the back of the pouch 2 After attaching the electrodes to the patient place the Trex HD Monitoring into the pouch with the electrode wires exiting at the top or on the sides as required 3 Close the...

Страница 41: ...op or on the sides as required 3 Close the zippers as much as possible so that the Trex HD Monitoring is secured in the pouch 4 Once the Trex HD Monitoring is enclosed in the pouch place the lanyard o...

Страница 42: ...t Event Button into the Patient Event connection on the headbox 3 If a Photic Stimulator is needed insert the Photic Stimulator into the Photic Stimulator connection on the base unit 4 When you are re...

Страница 43: ...els for example C3 CZ C4 T4 T5 P3 etc 7 Apply a sine wave of 50 microvolts peak to peak amplitude 10 Hz to all channels of the group using a signal generator Ensure there is a 50 Ohm load on the gener...

Страница 44: ...en an impedance check is initiated the software scans all channels in auto scan mode To Do this Start the impedance check Choose Controls Impedance Check Lock onto a channel Click Lock Channel Then ma...

Страница 45: ...or implied license to use the device with replacement parts which would alone or in any combination with this device fall within the scope of one or more of the patents relating to this device 10 2 I...

Страница 46: ...0SS Sensor Reusable Soft Small 1 m 3 ft cable 8000SS 3 Sensor Reusable Soft Small 3m 9 8ft cable 8000SM Sensor Reusable Soft Medium 1 m 3 ft cable 8000SM 3 Sensor Reusable Soft Medium 3 m 9 8 ft cable...

Страница 47: ...fect the accuracy of the measurement include the following excessive ambient light excessive motion electrosurgical interference blood flow restrictors arterial catheters blood pressure cuffs infusion...

Страница 48: ...is not used and d Two new AA batteries must be inserted This will ensure that your ambulatory amplifier has enough onboard memory and battery power to record for the duration of the study It is recomm...

Страница 49: ...OSAT must be turned off on the acquisition station b Sampling frequency must be set to 200 Hz c Wireless monitoring must not be used or minimized d Two new AA batteries must be inserted and e An exter...

Страница 50: ...supply charge the battery to approximately 40 charge prior to storing and recharge annually if not used sooner Battery should not be left in a discharged state Recharge battery immediately after use D...

Страница 51: ...ex HD Monitoring from the acquisition computer 4 Connect a fully charged battery pack to the Trex HD Monitoring using the Trex HD Monitoring cable provided 5 Place the battery pack securely in the Tre...

Страница 52: ...t Trex HD Ambulatory in the first drop down box 3 In the Channel Status section select Set manually 4 In the pane below select the following channels All DC channels DC1 DC2 DC3 and DC4 Differential C...

Страница 53: ...wipe all surfaces The Trex HD Monitoring amplifier is designed to be extremely portable As such the Trex HD Monitoring is subject to increased daily wear and tear Taking basic care of the system and...

Страница 54: ...ral state and local laws be followed for proper disposal of printed circuit boards plastics and metal parts For disposal of non Natus accessories please follow the instructions provided with these ite...

Страница 55: ...circuit such as printers mechanical beds vacuum cleaners or other potential sources of interference Install a medical grade ground to make sure that your clinic has a properly grounded electrical sys...

Страница 56: ...taskbar 3 Choose Shut Down from the Start menu 4 Select Restart the computer and click Yes Step 4 Shut Down the Computer Sometimes you need to shut down the computer completely in order to solve a pro...

Страница 57: ...E Electrical Warnings and Cautions 16 Electromagnetic Emissions 9 Electromagnetic Immunity 9 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING 11 Electromagnetic Immunity...

Страница 58: ...nt Electrical Connections 29 Physical Capabilities 29 Trex HD Monitoring Amplifier 29 Operating Parameters 30 Safety 29 Trex HDTrex HD Monitoring Amplifier Wireless Transceiver 30 Standards of Complia...

Страница 59: ...Unpacking 33 Using the Manual 6 V Verification 42 W Warnings 14 Conducted 24 Conducted Immunity 22 Electrical 16 Electrostatic 23 ESD 23 External Power Pack 49 General 14 Patient Environment 17 Pulse...

Страница 60: ...ort team staffed with technical and clinical experts 24 7 support remote support via WebEx or VPN the largest clinical and technical field support network in Neuro Sleep and customized service contrac...

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