Xavant STIMPOD MMS460 Manual Download Page 6

Guidance and manufacturer’s declaration – electromagnetic immunity

The STIMPOD NMS460 is intended for use in the electromagnetic environment specified below. The customer or the user of the STIMPOD NMS460 should assure that it is used in such an 
environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3V at 0.15 - 80MHz and 6V at ISM 

Frequency. 

Home Healthcare: 3V at 0.15 - 80MHz, and 

6V at ISM and Radio Amateur Frequency.

3 V/m (10V/m Home Healthcare) at 

80 - 2,700MHz, AM Modulation. And 

9-28V/m at 385-6000MHz, Pulse Mode and 

other Modulation (upon Risk Analysis).

3V at 0.15 - 80MHz and 6V at ISM 

Frequency. 

Home Healthcare: 3V at 0.15 - 80MHz, and 

6V at ISM and Radio Amateur Frequency.

3 V/m (10V/m Home Healthcare) at 

80 - 2,700MHz, AM Modulation. And 

9-28V/m at 385-6000MHz, Pulse Mode and 

other Modulation (upon Risk Analysis).

Portable and mobile RF communications equipment should be used no 
closer to any part of the STIMPOD NMS460, including cables, than the 

recommended separation distance calculated from the equation applicable 

to the frequency of the transmitter.

Recommended separation distance

d = 1,2   

 80 MHz to 800 MHz

d = 2,3   

 800 MHz to 2,5 GHz

where P is the maximum output power rating of the transmitter in watts 

(W) according to the transmitter manufacturer and d is the recommended 

separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an 

electromagnetic site survey, 

a

 should be less than the compliance level in 

each frequency range. 

Interference may occur in the vicinity of equipment marked with the 

following symbol:

 

NOTE 1  

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2  

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a

  Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV 

broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be 
considered. If the measured field strength in the location in which the STIMPOD NMS460 is used exceeds the applicable RF compliance level above, the STIMPOD NMS460 should 
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the STIMPOD NMS460.

v

Summary of Contents for STIMPOD MMS460

Page 1: ...PRODUCT CODE XT 46006 EN XM400 31A04 07...

Page 2: ...i...

Page 3: ...be observed to verify normal operation in the configuration in which it will be used The patient should avoid contact with metallic objects that are grounded produce an electrical conductive connectio...

Page 4: ...e stimulators are a symptomatic treatment and as such suppresses the sensation of pain that would otherwise serve as a protective mechanism Effectiveness is highly dependent upon patient selection by...

Page 5: ...healthcare pro fessional only This equipment system may cause radio interference or disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re orienting or re...

Page 6: ...e d 1 2 80 MHz to 800 MHz d 2 3 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separatio...

Page 7: ...pplicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separa...

Page 8: ...er 4 1 8 Shutdown 4 1 9 Symbols on device battery clip 4 2 Setting up Device Defaults 5 2 1 Languages 5 2 2 Stimulation Mode 5 2 3 Pulse Width Options 6 2 4 Stimulating Frequency 6 2 5 Countdown Timer...

Page 9: ...n those supplied with the STIMPOD NMS460 may result in serious injury NOTE Standard ECG Electrodes can be used for the anode Such ECG electrodes need to conform to ANSI AAMI EC12 on disposable ECG ele...

Page 10: ...s to Enter in setup menu Stimulating LED indicator Flashing Green Stimulus delivered Flashing Red Open Circuit detected Menu Pulse Width Button Press to toggle between Pulse Widths Press and hold to a...

Page 11: ...too high higher than 13 kOhm This is most likely caused by a poor grounding electrode skin connection Pause This warning informs the user that the PAUSE button was pressed The STIMPOD NMS460 will pau...

Page 12: ...ircuit Detection A few milliseconds prior to the actual stimulation an impedance measurement is made to detect whether the connection between the STIMPOD NMS460 and the patient comprises a closed circ...

Page 13: ...croll down the menu to EXIT MENU and press enter A conformation screen will show your selection with an option to ACCEPT YES will take you back to the main Setup Menu NO will take you to the previous...

Page 14: ...ter A confirmation screen will show your selection with an option to ACCEPT YES will take you back to the main Setup Menu NO will take you back to the previous screen 2 5 Countdown Timer DEFAULT 10 mi...

Page 15: ...rstheusertheoptiontoenteruserinformation Twolinesof20 characters each may be entered This user information will be displayed for two seconds when unit is switched on as per example Use the Wheel to na...

Page 16: ...ld flash GREEN and if sound is enabled in the menu a beep should be heard each time a stimulus is delivered Stimulus should occur at the set frequency 1 2 or 5 Hz Use the adjusting wheel and slowly in...

Page 17: ...er Consumption 17mA Weight 130g Dimensions 145mm x 90mm x 30mm Operating Temperature 10 40 Celsius Storage and Transport Temperature 0 50 Celsius Operating Humidity 90 Relative Humidity 3 3 Cleaning a...

Page 18: ...e NMS 460 PERIPHERAL NERVE STIMULATOR ONLY XT 46000 No cables or accessories NMS 460 PERIPHERAL NERVE STIMULATOR KIT XT 46001 Including Mapping Probe Carry Case IFU NERVE MAPPING CABLE XT 46003 CARRY...

Page 19: ...11...

Page 20: ...Unit 102 The Tannery Industrial Park 309 Derdepoort Rd Silverton Pretoria South Africa 0184 Tel 27 0 12 743 5959 Fax 27 0 86 547 0026 E mail support xavant com Web www xavant com...

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