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44

Note 2

These guidelines may not apply in all situations. Electromagnetic propaga-
tion is affected by absorption and refl ection from structures, objects and 
people

a)  The ISM (industrial, scientifi c and medical) bands between 150 kHz and 80 MHz are 6.765 MHz 

to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 
40.70 MHz.

b)  The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the 

frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable 
communications equipment could cause interference if it is inadvertently brought into patient 
areas. For this reason, an additional factor of 10/3 is used in the calculating the recommended 
separation distance for transmitters in these frequency ranges.

c)  Field strengths from fi xed transmitters, such as base stations of 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 fi xed RF 
transmitters, an electromagnetic site survey should be considered. If the measured fi eld strength 
in the location in which the MultiStim SWITCH is used exceeds the applicable RF compliance level 
above, the MultiStim SWITCH should be observed to verify normal operation. If abnormal per-
formance is observed, additional measures may be necessary, such as reorienting or relocating the 
MultiStim SWITCH.

d) Over the frequency range of 150 kHz to 80 MHz, fi eld strengths should be less than 10 V/m.

Limitation of Warranty/Disclaimer

PAJUNK

®

 GmbH Medizintechnologie guarantees to manufacture its products with greatest possible 

care.
THIS IS THE ONLY VALID GUARANTEE, AND IT SHALL REPLACE ALL OTHER WARRANTIES GIVEN AND 
REPRESENTATIONS MADE. It shall be observed, that due to the biological differences of the persons to 
be treated, no product is always absolutely effective under all environmental conditions and circum-
stances. Components of the sets manufactured by PAJUNK

®

 GmbH Medizintechnologie, as well as their 

individual components are compatible with each other. Before the use of individual products/sets of 
PAJUNK

®

 GmbH Medizintechnologie in connection with products from other companies, the user must 

ensure the application-specifi cal compatibility of the individual products. PAJUNK

®

 GmbH Medizin-

technologie has no infl uence on the application of the product, on the diagnosis of the patient and on 
the handling of the product outside of the company. PAJUNK

®

 GmbH Medizintechnologie can neither 

guarantee a benefi cial nor a complication-free application of the product. PAJUNK

®

 GmbH Medizin-

technologie therefore assumes no liability for damages and costs. 
PAJUNK

®

 GmbH Medizintechnologie will replace products showing a defi ciency, which is to be rep-

resented by PAJUNK

®

 GmbH Medizintechnologie. Employees of PAJUNK

®

 GmbH Medizintechnologie 

shall not be authorised to amend the aforementioned conditions, to extend liability, or to accept or 
consent to additional product-related obligations.

General Notes

In accordance with U.S. law, this product may only be sold by a physician or upon his prescription.
All rights to change or modifi cation of the product shall remain reserved.
Products are free of latex.
Made in Germany – manufactured by PAJUNK

®

 GmbH Medizintechnologie

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XS190174B MultiStim SWITCH GB.indd   44

XS190174B MultiStim SWITCH GB.indd   44

12.03.10   13:53

12.03.10   13:53

Содержание MultiStim SWITCH

Страница 1: ...MultiStim SWITCH and MultiStim SENSOR Setting the trend in nerve stimulation Plexus and Epidural Anaesthesia...

Страница 2: ...e following advantages The MultiStim SENSOR supports patient friendly percutaneous localization and identification of nerves with the aid of a stimulation handle the PEG electrode Percutaneous Electro...

Страница 3: ...ent which can be corrected immediately Integrated safety functions High precision microprocessor controlled adjustment of constant current Device type BF Battery 9 V Current intensity max 6 mApp 20 mA...

Страница 4: ...ed through the skin without requiring a puncture which will evoke a reflexive response when the nerve is encountered The cannula is introduced at the insertion point identified by means of this method...

Страница 5: ...tatus indicator in the display The intensity and the frequency of the stimulation current as well as the pulse width can be adjusted separately for both outputs This button will remain without functio...

Страница 6: ...N OFF PAUSE Pulse width Turning knob Pulse width Battery condition Patient resistance Current intensity Actually flowing current NOMINAL ACTUAL current Active output for example Cannula MultiStim SWIT...

Страница 7: ...Y patient cable point PAJUNK has set new standards in electrical nerve stimulation because for the first time ever it provides the option for alternative stimulation by means of cannula or by stimulat...

Страница 8: ...mmediate identification and correction of a misplaced cannula before mechanical or chemical injuries The revolution in the nerve stimulation More safety through the indication of pat are caused Becaus...

Страница 9: ...o analogous bar graphs The measurement of the resistance connected therewith is only possible if the highly precise PAJUNK stimulation cannula are used An individual threshold value can be predefined...

Страница 10: ...be increased to 20 mA and will therefore correspond with the specific requirements of epidural stimulation The intensity and the frequency of the stimulation current as well as the pulse width can be...

Страница 11: ...s these steps will be correspon dingly large at great distances to the nerve and will become smaller as the cannula approaches the nerve see accompanying table Automatic adjustment of the current inte...

Страница 12: ...n of stimulation cannula and monopolar handle 1151 94 32 Accessories 1 Patient cable for the connection of stimulation cannula 1151 94 13 2 PEG cable for the connection of stimulation cannula and mono...

Страница 13: ...Peripheral Epidural Spinal MultiStim SWITCH XS190174B MultiStim SWITCH D indd 1 XS190174B MultiStim SWITCH D indd 1 08 04 10 11 47 08 04 10 11 47...

Страница 14: ...TUP functions 35 5 1 1 SETUP LEVEL 1 Volume control 35 5 1 2 SETUP LEVEL 2 Setting of the initial parameters for Cannula mode 36 5 1 3 SETUP LEVEL 3 Setting of the initial parameters for Catheter mode...

Страница 15: ...s Suitcase for storing SWITCH and accessories Please observe by all means The patient main cable of the MultiStim SWITCH is compatible with that of the MultiStim SENSOR due to its technical design Ple...

Страница 16: ...esive electrode will lead to a malpositioning of the stimulation cannula please ensure that the adhesive electrode which functions as a neutral electrode here is in sufficiently sound contact with a l...

Страница 17: ...unintentional short circuits or leakage currents These may lead to partial or even total diversion of the stimulation currents which will cause the stimulation effect to decline or even to fail compl...

Страница 18: ...indicated exactly on the display Current constant devices which permit the selection of the current intensity mA for the stimulus impulse have gained acceptance within the last few years For the Multi...

Страница 19: ...circuit is closed i e stimulation current is running through the patient The control sound will become more intensive in this case Due to a high stimulus voltage of max 95 Vss this renders an exceptio...

Страница 20: ...e impulse bandwidth Mode Impulse frequency 3 4 The elements of the display Symbol Meaning Indicates must current is displayed in mA Indication of the electrical patient circuit Electric circuit not cl...

Страница 21: ...0 1 description see table in chapter Setup Level 5 4 Operation 4 1 Pre operational check Please observe Equipment with divergent behavior may not be put into operation In this case please contact the...

Страница 22: ...m the one described in 3 and 4 then a faulty cable could be the cause short circuit interruption Check the function once more with a second cable Finally remove the red short cir cuit plug from the so...

Страница 23: ...bandwidth are separately adjustable for both of the two outputs see SETUP functions 4 6 Mode catheter CATH Aside of stimulation using an invasive stimulation cannula MultiStim SWITCH addition ally of...

Страница 24: ...Incremental step 0 00 mA 0 50 mA 0 02 mA 0 mA 2 mA 0 1 mA 0 50 mA 1 00 mA 0 05 mA 2 mA 5 mA 0 2 mA 1 00 mA 2 00 mA 0 10 mA 5 mA 10 mA 0 5 mA 2 00 mA 4 00 mA 0 20 mA 10 mA 20 mA 1 0 mA 4 00 mA 6 00 mA...

Страница 25: ...TUP button for a longer period of time min 2 seconds will permanently store the volume value currently indicated on the display A monitoring sound is audible during the store procedure The device will...

Страница 26: ...3 8 4 Please observe The settings for the frequency and the impulse bandwidth must be adjusted in normal operation i e before pressing the SETUP button for the first time The intensity of the current...

Страница 27: ...n which allows you to adjust the pulse width for the cannula mode Here the pulse width selection mode can be selected by means of the turnable key button You can either choose manual selection Selecti...

Страница 28: ...rned to the manufacturer for repair Please ask your dealer if you need assistance he will be glad to help you Please indicate the error code in the repair order The following error codes are possible...

Страница 29: ...of the functionality test before the first operational use of the device 2 Date and time of the familiarization as well as the names of the persons familiarized with the opera tion of the device 3 Dat...

Страница 30: ...ding 15 s are possible particularly for fall time 12 Notes warnings If you have adjusted a stimulation current intensity 0 06 mA or 0 2 mA during operation in the CATH mode and 0 00 mA are indicated i...

Страница 31: ...laration Electromagnetic Emissions according to EN 60601 1 2 2007 5 2 2 1 Table 1 MultiStim SWITCH is intended for use in the electromagnetic environment specified below The customer or user of the Mu...

Страница 32: ...EC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Not applicable Not applicable Surges according to IEC 61000 4 5 1kV line s to line s 2kV line s to earth Not applicable Not applica...

Страница 33: ...quation applicable to frequency of the transmitter Recommended separa tion distance d 3 5 U1 P for 150kHz to 80MHz d 12 U1 P for 80MHz to 800MHz d 23 U1 P for 800MHz to 2 5GHz where P is the maxi mum...

Страница 34: ...e guarantees to manufacture its products with greatest possible care THIS IS THE ONLY VALID GUARANTEE AND IT SHALL REPLACE ALL OTHER WARRANTIES GIVEN AND REPRESENTATIONS MADE It shall be observed that...

Страница 35: ...hthalates as identified Does not contain latex Contains latex Non pyrogenic Pieces Catalog number Unique identifier Batch Identification Use by date Date of manufacture Device Type BF Catalogue Excerp...

Страница 36: ...H Medizintechnologie Karl Hall Stra e 1 D 78187 Geisingen Germany Telefon 07704 9291 0 Telefax 07704 9291 600 www pajunk com 0124 XS190174B MultiStim SWITCH E indd 136 XS190174B MultiStim SWITCH E ind...

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