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10. Specific requirements for the US market

To U.S.A Customers:

The User Manual packaged with the nerve stimulator includes all the procedures and re-
quirements for operation the Stimuplex

®

HNS 12 Nerve Stimulator. Please heed all warnings

and recommendations presented in the manual. For our US customers only, the following
revisions and/or additions should be used in place or in conjunction with the information
provided within the manual.
Thank you.
B. Braun Medical Inc.

10.1. Addition to Section “5.6. Maintenance and safety checks” of

the Manual

Service and Technical Support:
If, during the initial warranty period, the Stimuplex

®

HNS 12 fails to respond to the operating

or troubleshooting procedures listed in this manual and the cause cannot be determined,
discontinue using the unit and contact B. Braun Medical Customer Service for further in-
struction regarding Warranty Service Support and Repair:

B. Braun Medical Inc.
824 Twelfth Avenue
Bethlehem, PA 18018-3524, USA
Ph: 1-800-227-2862

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Содержание Stimuplex HNS 12

Страница 1: ...Stimuplex HNS 12 Nerve Stimulator for Peripheral Regional Anesthesia User Manual GB ...

Страница 2: ...71 0 Fax 1 610 758 9020 Fax 49 0 761 20716 20 Fax 49 0 5661 71 4845 Email inquiry bbraunusa com Email info stockert de Email StimuplexHNS12 bbraun com http www bbraunusa com http www stockert de http www bbraun com The Stimuplex HNS 12 may only be used in applications for which this product is intended Federal US law restricts this device to sale by or on the order of a physician Meliseptol Stimup...

Страница 3: ...tor dial and keys 24 2 2 3 Sound 26 2 2 4 LED 26 2 2 5 Display modes 27 2 2 6 Menu structure 29 3 Operation of the Stimuplex HNS 12 32 3 1 Stand by 32 3 2 Selecting the current adjustment range 33 3 3 Selecting the stimulation current 34 3 4 Selecting the stimulus duration 34 3 5 Selecting the stimulation frequency 37 3 6 Current threshold display 37 3 7 Checking the battery voltage 38 3 8 Additio...

Страница 4: ... 43 5 Initial setup maintenance and notes 46 5 1 Testing the Stimuplex HNS 12 46 5 2 Special technical features 47 5 3 Technical data 48 5 4 Battery 49 5 5 Cleaning and disinfecting the Stimuplex HNS 12 50 5 6 Maintenance and safety checks 50 5 7 Equipment logbook Specific requirement for use on German market 51 5 8 Notices 51 5 9 Error messages 52 5 10 Instruments and accessories 56 6 References ...

Страница 5: ... 5 10 Specific requirements for the US market 75 10 1 Addition to Section 5 6 Maintenance and safety checks of the Manual 75 ...

Страница 6: ...on including a discussion of the principle of constant current stimulation For your study of its operational fundamentals we recommend that you have a Stimuplex HNS 12 with all of its accessories at hand and functional so that you can learn about the functions in practical exercises It is helpful to simulate the patient with a wet paper tissue or a small sponge soaked in saltwater The saline solut...

Страница 7: ... direct contact of the injection needle with the nerve is intentionally avoided The Stimuplex HNS 12 nerve stimulator shall be used only by medical personnel trained and experienced in the techniques of peripheral nerve stimulation and only in the clinical environment not in home care environment Since peripheral electrical nerve stimulation PNS is no substitute for the anatomical knowledge requir...

Страница 8: ... stimula tion The A alpha motor fibers have the shortest chronaxia 50 100 µs The afferent fibers that transmit pain sensation Aδ and C fibers require a longer pulse 150 and or 400 µs at a minimum current Mixed peripheral nerves can be localized using short pulses 0 10 ms without triggering pain sensations For pure sensory nerves a longer pulse is recommended 0 30 ms 0 50 ms or 1 00 ms When unipola...

Страница 9: ...cial attention must be paid as the current density at needle tip can exceed 2 mA cm2 depending on stimulation settings The Stimuplex HNS 12 is meant for long term usage 1 2 Intended Use The nerve stimulator is intended for localisation of nerves in peripheral regional anesthesia Under no circumstances may it be used on a patient undergoing surgery 1 3 Indications Surgical interventions on the uppe...

Страница 10: ... as well as the applicable collateral standards The user should be aware that even when all rules are complied with for each piece of equipment under worst circumstances all leakage currents or auxiliary patient coupled currents can add up and produce unacceptably high levels that can endanger the patient The user must there fore check in advance whether the interconnected equipment might exceed a...

Страница 11: ...t the needle tip and cause irreversible destruction to the nerve fibers in this proximity At the same time the ported stimulator can rectify the high frequency energy which leads to extremely high direct currents and voltage potentials at the electrodes The direct current stimulation generated as a result can be very painful and strong and trigger irreversible electrophysiological reactions 6 To p...

Страница 12: ...coustic warning whenever the target stimulation current is set below this value 13 If the stimulator shows a direct current or an offset direct current at the outlet the stimulator should not be used and must be returned to the manufacturer for repair These failures can be detected by performing a simple functional test with the testing resistor see Section 5 1 Testing the Stimuplex HNS 12 14 The ...

Страница 13: ...ee Section 9 Electromagnetic compatibility EMC 19 Do not use the device after ingress of liquids Ingress of liquids or humidity can cause an electronic failure 20 To avoid damage to the connecting cable and the device do not hold or carry the device by its connecting cables and or its accessories Do not wrap the cable around the device or around other equipment 21 Wrapping the connecting cable dur...

Страница 14: ...act the stimulation outcome and under certain circumstances may lead to adverse stimulation effects in the tissue 29 Before and during use the device the connecting cable and their plugs must be kept completely clean and dry Moisture and contamination will impair the function of the nerve stimulator and or the stimulation outcome 30 Be aware of the position of metallic implants in the tissue e g p...

Страница 15: ...ous substances in electrical and electronic equipment RoHS II Directive 2012 19 EU Directive 2012 19 EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment WEEE FDA 21 CFR 21 Part 801 FDA Code of Federal Regulations Title 21 Part 801 Subpart A Labeling FDA 21 CFR 21 Part 820 FDA Code of Federal Regulations Title 21 Part 820 QS regulation Subpar...

Страница 16: ...e processes IEC 62353 Medical electrical equipment Recurrent test and test after repair of medical electrical equipment IEC 62366 Medical devices Application of usability engineering to medical devices ISO 13485 Medical devices Quality Management Systems Requirements for regulatory purposes ISO 14971 Medical devices Application of risk management to medical devices ISO 15223 1 Medical devices Symb...

Страница 17: ...nerve stimulator that allows the user to select the desired current mA exactly between the two electrodes skin electrode anode and stimulation needle cathode Nevertheless a stimulator with constant current settings must be equipped with a very high output impedance ideally infinity to reduce the resistances possible in the external circuit to negligible levels and to display the actually flowing c...

Страница 18: ... functions of Stimuplex HNS 12 Stimuplex and Contiplex stimulation needles as well as the connecting cable by B Braun are designed to work in perfect harmony Only in this way can an optimum of precision and reliability be achieved For more in depth knowledge about the use of this device its risks and side effects we rec ommend studying in detail the relevant literature cited in the References Sect...

Страница 19: ... 19 Overview of the Stimuplex HNS 12 Nerve Stimulator ...

Страница 20: ...r to the middle 4 polar plug The plug connector configuration prevents wrong polarity connection 2 Check if the battery is installed 3 Press the Stand by key to switch on the Stimuplex HNS 12 While you are holding down the Stand by key to switch on Stimuplex HNS 12 important equipment param eters are indicated in the unit s display After releasing the key the device automatically runs a self test ...

Страница 21: ...ted and the LED is not flashing If the target stimulation current is 0 00 mA and the actual stimulation current flowing does not deviate by more than 0 04 mA from the target stimulation current the green LED lights up or yellow if the optionally adjustable current threshold has been undershot and a stimulation frequency sound becomes audible The actual current is indicated automatically and only i...

Страница 22: ...nd the click or beep sound starts ticking louder at a higher pitch 8 To switch off the nerve stimulator hold down the Stand by key until the display disap pears switch off time 1 second If the key is released during this switch off phase the device switches back to ON status Refer specifically to the Section Warning and Safety information before using the Stimuplex HNS 12 on a patient If the devic...

Страница 23: ...ee electrical pulses of varying pulse duration at any given amperage The two accurate 0 1 ms pulses are sequenced with a pulse of longer duration e g 0 3 ms A longer duration pulse elicits motor responses at greater distance at lower frequency in creasing sensitivity The shorter pulses maintain the accuracy underlying successful nerve location whereas the longer duration pulse enables stimulation ...

Страница 24: ...or the Stimuplex Switch no longer available for continuing use of a remaining Stimuplex Switch please see instructions for use of Stimuplex Switch 2 2 2 Current regulator dial and keys Current regulator dial The current regulator dial is used to adjust the target stimulation current The dial can be turned infinitely but is graduated The maximum currents 5 or 1 mA can be achieved either with 2 turn...

Страница 25: ... desired stimulus duration Hz key Sets the desired stimulation frequency Stand by key On and off switch for the Stimuplex HNS 12 Briefly press the Stand by key To jump from the menu mode to the normal stimulation mode or to immediately delete a potentially existing mark ing in the stimulation mode e g 5 00 mA MENU arrow keys For navigation and settings in the menu The Stimuplex HNS 12 is very user...

Страница 26: ...n current The type of sound can be selected in the Setup menu Tone Mode The user can choose between a click and a beep sound When warnings actual stimulation current target stimulation current target stimulation current current threshold automatic switch off EEPROM and errors are signaled the click or beep changes to a louder and higher signal pitch Whenever any key is operated a short clear beep ...

Страница 27: ... mode With or without electrical charge nC display when in SENSe mode the stimulus duration of the three stimulus impulses generated per second is shown instead of the electrical charge nC 2 Stimulation mode with warning Actual stimulation current less than target stimula tion current ...

Страница 28: ... and down arrow keys and must be confirmed by pressing the right arrow key if applicable The checkmark then appears at the corresponding position 4 Error display mode For example indicating that the stimulation voltage is too low If an error message appears in the LCD display the device is automatically switched off within 8 seconds During this process the target stimulation current is set to zero...

Страница 29: ...tion 1 00 ms 0 50 ms optional 0 30 ms 0 10 ms 0 05 ms optional Frequency 2 Hz 1 Hz SENSe 3 Hz Current threshold On or Off no Info Battery level date serial no version Distributor Manufacturer USER INFO future option currently not available Activate infrared interface future option currently not available ...

Страница 30: ...ariable tone On or Off no Dial turns 1 or 2 Contrast 0 to 8 Automatic switch off 0 to 10 min in min increments 15 to 30 min in 5 min increments Date HH MM YYYY MM DD Language GB English D German F French E Spanish I Italian P Portuguese S Swedish NL Dutch ...

Страница 31: ... Czech SK Slovak SLO Slowenian PL Polish TR Turkish EST Estonian LV Latvian LT Lithuanian BG Bulgarian CN Chinese J Japanese Options Factory standard Yes Y Confirm using the right arrow key El charge nC On or Off no Auto adjust current On or Off no Add stimulus duration On or Off no SENSe On or Off no ...

Страница 32: ... Language English can only be changed in the menu is not reset by the Factory setting option If a language nor comprehensible to user should accidentally be set please follow Setup Language menu to reset to your country language 3 1 Stand by Switch on Press the Stand by key After the key is released a self test not displayed is run the stimulation mode is displayed and the device is ready for oper...

Страница 33: ...o ways 1 Selecting the current range for future switch on procedures Switch on the device Activate the Main Menu using the right arrow key and activate Current range using the right arrow key Select the desired range using the up or down key indicated by on the left and confirm with the right arrow key appears on the right next to the selection Switch off the device The current range now selected ...

Страница 34: ...30 ms and 1 00 ms these values are equivalent to those on Stimuplex HNS 11 If these 3 values are not sufficient for your application you can activate the menu item Add stimulus duration in the menu Setup Options appears next to Add stimulus duration on the right You can then choose between the values from the second series below The second series includes 0 05 ms 0 10 ms 0 30 ms 0 50 ms and 1 00 m...

Страница 35: ...80 0 89 mA 0 10 0 10 0 36 ms 0 90 0 99 mA 0 10 0 10 0 39 ms 1 00 1 09 mA 0 10 0 10 0 42 ms 1 10 1 19 mA 0 10 0 10 0 46 ms 1 20 1 29 mA 0 10 0 10 0 49 ms 1 30 1 39 mA 0 10 0 10 0 52 ms 1 40 1 49 mA 0 10 0 10 0 55 ms 1 50 1 59 mA 0 10 0 10 0 58 ms 1 60 1 69 mA 0 10 0 10 0 62 ms 1 70 1 79 mA 0 10 0 10 0 65 ms 1 80 1 89 mA 0 10 0 10 0 68 ms 1 90 1 99 mA 0 10 0 10 0 76 ms 2 00 2 24 mA 0 10 0 10 0 84 ms...

Страница 36: ... setting during an application only ms key Press the ms key The current value is highlighted by a border By repeatedly pressing the ms key the next higher value appears from the numerical series selected above Repeat edly press the ms key switch on all values consecutively The displayed value is immediately active The border disappears after approx 3 seconds 3 Changing the configured setting durin...

Страница 37: ...pplication Press the Hz key The set value is highlighted by a border By repeatedly pressing the Hz key the other value appears Repeatedly pressing the Hz key switches on the values alternately The displayed value is now active for this application the highlighting disappears after approx 3 seconds 3 6 Current threshold display Highlight the option Current threshold in the Main Menu and confirm usi...

Страница 38: ...u Navigate with the up down keys until the highlighting arrow is in front of the menu item Info Press the right arrow key to open the Info menu In the upper row the battery s remaining capacity is indicated in and volt 3 8 Additional information Menu info The menu Info has 5 pages With the up down keys you can scroll through these pages The version number format has the following meaning Version 1...

Страница 39: ... are immediately saved with the checkmark If you forget this and Stimuplex HNS 12 meanwhile switches off au tomatically the previous values remain configured 4 1 Setting switch on values for stimulation parameters Press the right arrow key MENU to activate the Main Menu 4 1 1 Current adjustment range The desired switch on value for the current range can be set under the menu item Current range Nav...

Страница 40: ...uring an application has no impact on the currently set values 4 1 3 Frequency The desired switch on value for the stimulation frequency can be set under the menu item Frequency Navigate with the up down keys until the marking arrow is in front of the menu item Frequency Press the right arrow key to confirm the menu item thereby activating the desired switch on value for the stimulation frequency ...

Страница 41: ... is not required here Use the option Variable tone to set whether the tone pitch should be dependent on the target stimulation current or whether you desire a consistent stimulation tone over the entire setting range Activate this option with the right arrow key appears on the right or inactivate it disappears The setting is active immediately 4 2 2 Dial turns The setting accuracy can be adjusted ...

Страница 42: ...lies from the last time the stimula tor has been operated It is factory set to 20 minutes on delivery The switch off time can be set to between 0 and 30 minutes If the value is set to 0 the device does not switch off automatically Open the Setup menu select the option Auto switch off and open it with the right arrow key Using the up or down key set the desired automatic switch off time The increme...

Страница 43: ...hting the desired language with the up or down key and activating your selection with the right arrow key appears on the right When switching to another language than English the English terms for Setup and Language menus are always additionally displayed behind the terms for the selected language to enable the user to reset the language when he unintentionally changed it 4 2 7 Options This menu p...

Страница 44: ...e 5 00 mA Dial turns 1 Stimulus duration SENSe Contrast 5 0 10ms 0 10ms 0 15ms 1 0ms Autom switch off 20 Min Frequency SENSe 3 Hz El charge nC Off Tone Beep Auto adjust current On Volume 5 Add stimulus duration Off Variable tone On SENSe On 4 2 7 2 Displaying the electrical charge of the stimulation pulse electrical charge nC By activating this menu item the electrical charge to be given off per s...

Страница 45: ...ulus duration is lowered with the ms key and then increased again without the dial being operated in the interim the target stimulation current is turned up to the old value again In the Setup menu open Options highlight Auto adjust current and activate or deactivate with the right arrow key 4 2 7 4 Additional stimulus duration With this option you can add the stimulus durations 0 05 ms and 0 50 m...

Страница 46: ...ge from 0 10 to 5 00 mA The warning Patient current lower than your setting must appear in the display the warning signal must be audible and the LED in the stimulation frequency must light up red 3 Now connect the electrodes clip and plugs using the 10 kΩ resistance supplied as an accessory At this time recheck the entire adjustment range to make sure that no warning is displayed the LED lights u...

Страница 47: ...the pulse of Stimuplex HNS 12 is shaped by extremely fast active pulse drivers at both slopes An output amplifier specially designed for this application has an extraordinarily wide dynamic range and generates reproducible settings even below 0 10 mA The latest microcomputer technology has made it possible to integrate performance features into the Stimuplex HNS 12 that until now could only be pro...

Страница 48: ...ent measuring accuracy 5 or 0 04 mA which one is greater in a 0 5 kΩ to 12 kΩ load Impedance measuring range 1 kΩ 90 kΩ for target stimulation current 0 5 mA Impedance measuring accuracy 10 20 for target stimulation current 1 mA 1 mA Sound pressure level 51 dB 54 dB 63 dB for stimulation warning error Weight 250 g IP protection class IPX0 Operational Environmental Conditions Temperature 0 C to 40 ...

Страница 49: ...used for a long period of time the battery must be removed to prevent leakage The battery compartment is located in the base of the nerve stimulator Open the compartment Change the battery ensuring correct polarity Then close the compartment When inserting the battery please insure that polarity is correct and that there is a firm connection between the battery and the contacts Use only 9 V alkali...

Страница 50: ...vents acids and sodium hydroxide solution Disinfectants containing iodine or dyes can discolor the housing and should not be used 5 6 Maintenance and safety checks Check the serviceable condition of the Stimuplex HNS 12 and accessories on each occasion before use A defective instrument must not be used Electromedical equipment may only be repaired by the manufacturer or by an organization expressl...

Страница 51: ...nd the name of the instructed persons 2 4 Deadlines and dates for performing prescribed safety checks and mechanical in spections and their results and the date of maintenance work including the name of the person or company responsible for carrying out these measures 5 8 Notices General notes The cables of the nerve stimulator Stimuplex HNS 12 should be positioned in such a way that they do not c...

Страница 52: ...ecks the battery voltage periodically If the voltage is less than 6 00 V an error message will be displayed and the device will switch off automatically The used battery must be replaced immediately An empty battery can leak damaging the device and making it unusable If the device is not used for a longer period of time it is imperative that the battery is removed Any damage caused by a leaking ba...

Страница 53: ...emory error 4 CPU computer error 5 ROM program memory error 6 ADC analog digital converter error 7 Frequency error Signal Specification All specification values have 10 tolerance Stimulation Information Signals Reset Action Tone variable LED Pattern Frequency Repetition On Color Repetition 1 Hz Stimulation ti 2 kHz to 0 925 kHz 1 s 0 05 s green 1 s 2 Hz Stimulation ti 2 kHz to 0 925 kHz 0 5 s 0 05...

Страница 54: ...rent threshold SENSe ca 3 Hz Stimulation 3 impulses in 1 s 350 ms 350 ms 300 ms tiTii 2 kHz 1 2 kHz 1 s 0 05 s yellow 1 s Patient current lower than your setting 1 Hz Stimulation tiTii 2 7 kHz 1 4 kHz 1 s 0 05 s red 1 s Patient current lower than your setting 2 Hz Stimulation tiTii 2 7 kHz 1 4 kHz 0 5 s 0 05 s red 0 5 s Patient current lower than your setting SENSe ca 3 Hz Stimulation 3 impulses i...

Страница 55: ...ROR Device defective Service required 8s Switch off time ti 2 7 kHz 0 25 s 0 25 s 0 5 s 0 05 s Red 0 25 s 0 25 s 0 5 s CPU ERROR Device defective Service required 8s Switch off time ti 2 7 kHz 0 25 s 0 25 s 0 5 s 0 05 s Red 0 25 s 0 25 s 0 5 s ROM ERROR Device defective Service required 8s Switch off time ti 2 7 kHz 0 25 s 0 25 s 0 5 s 0 05 s Red 0 25 s 0 25 s 0 5 s ADC ERROR Device defective Serv...

Страница 56: ...ge K U EEPROM INIT then appears during every switch on procedure In this case the device might run at slightly changed stimulation settings Please send in the device immediately to the manufacturer or distributor for repairs or testing Loading a language If an error occurs when changing the language the device will automatically switch back to English During this procedure the LCD may briefly go b...

Страница 57: ... 35 mm 22 G x 2 0 70 x 50 mm 21 G x 2 0 80 x 50 mm 21 G x 4 0 80 x 100 mm 20 G x 6 0 90 x 150 mm Contiplex D needles 15 bevel 18 G x 2 1 8 1 3 x 55 mm 18 G x 4 3 8 1 3 x 110 mm Contiplex D needles 30 bevel 18 G x 2 1 8 1 3 x 55 mm Contiplex D catheter set Contiplex catheter 0 41 x 0 71 x 400 mm with 20G Contiplex D cannula 15 bevel 1 1 x 33 mm with 20G Contiplex D cannula 15 bevel 1 1 x 55 mm Cont...

Страница 58: ...ith 20 bevel with Contiplex catheter 0 45 x 0 85 x 500 mm 18 G x 2 1 3 x 50 mm 18 G x 4 1 3 x 100 mm 18 G x 6 1 3 x 150 mm Contiplex S Ultra Needles with 20 bevel with Contiplex catheter 0 45 x 0 85 x 1000 mm 18 G x 2 1 3 x 50 mm 18 G x 4 1 3 x 100 mm 18 G x 6 1 3 x 150 mm Contiplex S Ultra 360 Needles with 20 bevel 18 G x 2 1 3 x 50 mm 18 G x 4 1 3 x 100 mm 18 G x 6 1 3 x 150 mm Contiplex S 360 o...

Страница 59: ...x 360 only for China Needles with 30 bevel 22G x 1 1 3 0 7 x 35 mm 22G x 2 0 7 x 50 mm 22G x 3 1 8 0 7 x 80 mm 20G x 4 0 9 x 100 mm 20G x 6 0 9 x 150 mm Stimuplex Onvision 22G x 2 0 7 x 50 mm 22G x 3 1 8 0 7 x 80 mm 20G x 4 0 9 x 100 mm 22G x 4 3 4 0 9 x 120 mm 20G x 6 0 9 x 150 mm Stimuplex Pen Pen for stimulation of nerves through skin for the purposes of nerve mapping before nerve block applica...

Страница 60: ...n Regional Anaesthesie 13 172 7 März P 1990 Kann bei der elektrischen Nervenstimulation aus der Intensität der Mus kelkontraktion auf den Abstand zum Nerven geschlossen werden Regional Anaesthesie 13 179 8 Selander D Edshage S Wolff T 1979 Paraesthesiae or no paraesthesiae nerve lesions after axillary block Acta anaesthesiol scand 23 27 9 Kaiser H Die periphere Nervenstimulation In Niesel HC Hrsg ...

Страница 61: ... ms or 0 30 ms or 0 50 ms or 1 00 ms Stimulation frequency 1 Hz 2 Hz or SENSe Output voltage Û 95 V without load open Output impulse current Î maximal 1 00 mA or 5 00 mA short circuit Ca 3 Hz 3 impulses in 1 s 350 ms 350 ms 300 ms see Section 3 4 Selecting the stimulus duration for more details ...

Страница 62: ... 120 1 0 400 0 5 0 1 50 0 3 150 1 0 500 0 6 0 1 60 0 3 180 1 0 600 0 7 0 1 70 0 3 210 1 0 700 0 8 0 1 80 0 3 240 1 0 800 0 9 0 1 90 0 3 270 1 0 900 1 0 0 1 100 0 3 300 1 0 1000 1 2 0 1 120 0 3 360 1 0 1200 1 6 0 1 160 0 3 480 1 0 1600 1 8 0 1 180 0 3 540 1 0 1800 2 0 0 1 200 0 3 600 1 0 2000 2 5 0 1 250 0 3 750 1 0 2500 3 0 0 1 300 0 3 900 1 0 3000 3 5 0 1 350 0 3 1050 1 0 3500 4 0 0 1 400 0 3 120...

Страница 63: ...Appendix B according to IEC 60601 2 10 Load impedance as a function of battery voltage Setting stimulation current 5 00 mA Load impedance as a function of battery voltage Setting stimulation current 1 00 mA ...

Страница 64: ... 64 Actual stimulation current as a function of load impedance Setting target stimulation current 5 00 mA battery voltage 9 0 V Output voltage as a function of load impedance ...

Страница 65: ... 65 Target stimulation current as a function of adjustment control setting relative to 0 Setting 2 turns ...

Страница 66: ... 66 Appendix C according to IEC 60601 2 10 ...

Страница 67: ...Infrared transmission for service only Volume Shut off procedure Remote control active Single handed remote control active The Remote Control is no longer available Remote control inactive Single handed remote control inactive The Remote Control is no longer available Patient coupled circuit open Type BF applied part Caution Remote Control Connector Single handed remote control The Remote Control ...

Страница 68: ...60601 1 2005 A1 2012 CAN CSA C22 2 No 60601 1 2014 IEC 60601 1 6 2010 A1 2013 IEC 60601 2 10 2012 A1 2016 Control No E352559 Separate collection for electrical and electronic equipment currently applicable to EU community only CE marking with number of the notified body Distributor Catalogue number Batch number Serial number Humidity limitation storage and shipping conditions Atmospheric pressure ...

Страница 69: ...of a physician Russian GOST certification Ukraine conformity assessment body sign and number Keep dry The electrical and electronic product contains some hazardous substances which can be safely used during their environment friendly use period after their environ ment friendly use period expires they shall be put into the recycling system UA TR 039 ...

Страница 70: ...p 1 The Stimuplex HNS 12 utilizes RF energy for its internal function exclusively Therefore its RF emissions are very low and are unlikely to interfere with electronic equipment in the proximity RF emissions according to CISPR 11 Class A The Stimuplex HNS 12 is suitable for use in other facilities than the residential environments and such facilities that are directly connected to a public mains n...

Страница 71: ...discharge ESD according to IEC 61000 4 2 8 kV contact discharge 2 kV 4 kV 8 kV 15 kV air discharge 8 kV contact discharge 2 kV 4 kV 8 kV 15 kV air discharge The floors should be made of wood or cement or paved with ceramic tiles If the floor is made of synthetic material the relative humidity must be a minimum of 30 Fast transient electrical disturbances bursts according to IEC 61000 4 4 2 kV for ...

Страница 72: ...180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Not applicable Not applicable Power frequency magnetic fields 50 60 Hz according to IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should correspond to the values typical to those found in commercial and hospital environments ...

Страница 73: ...smitters in watts according to the transmitter manufacturer s information and d as recommended separation distance in meters m The field strength of stationary radio transmitters should be less than the compliance level at all frequencies based on on sitea testingb Malfunctions are possible in the environment of equipment that bears this symbol Remark 1 The higher frequency range is applicable at ...

Страница 74: ...er W Separation distance as a function of modulation frequency m 80 MHz to 800 MHz 800 MHz to 2 7 GHz d 1 17 P d 2 33 P 0 01 0 12 0 23 0 1 0 37 0 74 1 1 17 2 33 10 3 69 7 38 100 11 67 23 33 For transmitters whose maximal rated power is not listed in the table above the recommended separation distance d in meters m can be calculated by applying the equation that belongs to each column where P is th...

Страница 75: ...on with the information provided within the manual Thank you B Braun Medical Inc 10 1 Addition to Section 5 6 Maintenance and safety checks of the Manual Service and Technical Support If during the initial warranty period the Stimuplex HNS 12 fails to respond to the operating or troubleshooting procedures listed in this manual and the cause cannot be determined discontinue using the unit and conta...

Страница 76: ...pport with product function com plaints B Braun Medical Inc Clinical and Technical Support 824 Twelfth Avenue Bethlehem PA 18018 3524 USA Ph 1 800 854 6851 Fax 1 610 758 9020 You will be asked to provide the following information with each complaint 1 Unit Serial Number 2 Verification of last battery replacement date 3 Verification of completion of unit Short Test 4 contact name address phone numb...

Страница 77: ......

Страница 78: ...oftware version 1 003 x Stockert GmbH B Braun Melsungen AG Bötzinger Strasse 72 Carl Braun Strasse 1 79111 Freiburg 34212 Melsungen Germany Germany Phone 49 0 761 20716 0 Phone 49 0 5661 71 0 http www stockert de http www bbraun com ...

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