Technical Manual
Contents
1. The large buttons approx 10 mm diameter ensure a very good tactile feedback upon switch activation The large contact surface minimizes mechanical stress on the protective overlay The average lifetime of these switches is estimated at over 1 million operations All print of text and colors of the keyboard overlay is located on the rear side Thus the overlay has a very high resistance towards scratches and wear In fact potential damage to text and colors can only occur when the whole foil has been penetrated The overlay resists the detergents very well because there is no contact between the agents and the print 5 a 1 2 3 4 5 6 Technical Manual TOF Watch TOF Watch S and TOF Watch SX Short Setup Procedure Patient not relaxed Place electrodes in position attach the acceleration transducer to the thumb with adhesive tape perpendicular to the direction it moves Turn on the TOF Watch S SX by pressing the ON OFF button and holding it down for 1 second Adjust the stimulation current by pressing the mA uC up or down arrow buttons Administer the induction agent When the patient is sedated adequately press the CAL button for automatic calibration optional and hold it down for 1 sec Press the TOF button and hold it down for 1 sec to obtain repetitive TOF stimulation The TOF Watch S SX is now ready for monitoring the neuromuscular transmission b Patient already relaxed The use of automati2. Technical Manual TOF Watch TOF Watch S and TOF Watch SX Technical Manual TOF Watch TOF Watch S and TOF Watch SX TOF Watch is a registered trademark in one or more countries Objective Neuromuscular Transmission Monitoring devices Technical Manual June 2009 Schering Plough Corporation Marketing Anesthesia I II Sa 2 III Ne R IV Ne SR VI gt SR Ao ss gt R TS Technical Manual TOF Watch TOF Watch S and TOF Watch SX GENERAL INFORMATION eese esee eee eene sten tuse ta sns ta sens tastes tuse ta sensus eta sene ta sens enses tuae 5 DERVICE POLIGY 5 reete DeC epe doter e Mum 5 WARRANTY netter eec itr ode aea irt d re Beto irte eret 5 GENERAL INFORMATION ON DEVICES eeeeeeee esee ense en enne ea sns ta sins tn sees snae ta sos en aen 6 LIST OF SALES PACKAGES AND ACCESSORIES ccccccccecsesssaeceeececeesseaeeeeececeeseaesesececeessaeeeeeeeceeneaaeea 6 POWER SUPPLY ioco emo OG RO RERUM e Y RR PARET Orr epa Ure Ere ore yen 7 6 2077 MEE 7 Battery WANNE S ea tote io etti eoe iE Rege soe bo Dol Casu b festa repens aud 7 TOF WATCH S SX CABLES 5 ir rere tero re Eepe Ora SEA S iPab S rE ESER EEEn 8 Insertion and recognition eese sees enne tre nennen rennen enne enne nn enne amp SEEN IM amp KEYBOARD 2t2i2sei ssisissicavt AT E ues ndiacessebesstbensoveybeosesstonass 8 SHORT SETUP
3. TEST PROCEDURE ieee SRE EEE Pe Rte GE E NES AEE e PUR toscencesveu segues snares NEEE teseds outed 17 Routine CHECK procedure une Ren tu dete eee 17 Technical check procedure ee ee RR Ole e tr Rm eet ko tb ertet 18 Technical check record form teet tetigere tenen 19 OTHER USEFUL INFORMATION eeeeeeee eese enses enata tuse ta tune ta sensn sesto sees suse tatnen 20 APPENDIX queen 21 TOF W ATCH DEVICES AND ACCESSORIES eese enne nnn tn tnnt tnie teens nein innen 22 Devices CT EEUURS 23 General accessOries v s sioe er rn re SEHE A ees ead ca eek eeu e RU ae 25 Accessories for TOF Watch TOF Watch S eese tenerte rennen 29 Accessories for TOE Watcli SX riit penc ea neo equ 30 TOFPSEink QNOiACCESSOTICS os use IR er eene dys cate Shes suited ee eee yen esto ico eoe 31 Technical Manual TOF Watch TOF Watch S and TOF Watch SX l General I nformation This manual is designated to provide the marketing and sales staff with background information on the TOF Watch TOF Watch S and TOF watch SX and accessories The manual is meant for INTERNAL USE ONLY and should not be provided to third parties 1 Service policy The TOF Watch TOF Watch S and TOF Watch SX do not contain any serviceable parts Therefore a real service manual is not available for these devices However in many markets the biomedical engineer at the hospital s technical department or the tender
4. OK e check that stimulation current is above 10 mA 2uC in case of surface electrodes or 1 mA 0 04 uC for the needle electrodes local anesthesia e hold both connectors with the surface against each other e perform a repetitive 1 Hz stimulation if the symbol keeps flashing the cable is defective Flashing or 7 flashing surface needle electrode Indicates too high a skin resistance e can be caused by a poor quality of electrodes e the skin is not cleaned properly dirty skin Cleaning of the skin with isopropyl alcohol and the use of good quality electrodes such as Neotrode will ensure a proper skin resistance Flashing and 7 both surface and needle electrode symbols flashing simultaneously Indicates that no stimulation cable is connected to the TOF Watch surface or needle electrode 11 Technical Manual TOF Watch TOF Watch S and TOF Watch SX PTC flashing PTC cannot be performed because all necessary conditions are not present This error happens when e PTC is performed from pause mode when 1 Hz 0 1 Hz or TOF have not been not equal to 0 in the last 15 seconds e use TOF stimulation if 0 responses do a PTC e When the patient has 5 or more responses during the 15 single twitch stimulations preceding the tetanic stimulation e use TOF stimulation e stop the external noise movements of the hand e When PTC is activated before the time out period of 2 minutes is over TOF Watch automatically exclu
5. PROGEDURE 3 5 ra aas rne Rte hes see re RE e nas IA SA EE P a EYES 9 Patient not relaxed iie e eene eset en aie o Eo FETE VRESE 9 Patient already relaxed ee eese eee entente easet assassina trennen 9 CALIBRATION 3 essed teins aid ava ae aree d rate ate 10 TOF Watch Calibration sequence esee eese eee ne enne 10 TOF Watch S SX Calibration sequences eese eene nnne 10 C libr tion sequence Tortone eae b epe re reto e tU RE Ee Sore tee e berg 10 Calibration Sequence 25 reete OOo eet rag tet bebe te EU e Spe re pee ae ates 10 ERROR MESSAGES 2515 perti oO D UD OT e ro tee ee REA EO Pe E TRESS 11 CLEANING ADVICE FOR TOF W ATCH S SX esee eene enn ennemi nennen 13 REGULATORY INFORMATION eeeee eene teens tn stata seta tu seta sone ta sens enses enses sonent nen 14 GENERAL INFORMATION eale hinaa er did etie 14 ON CE MARKING etcetera ier et tein reri e eher ere ren 14 Establishing standards uiae deep eiie ee i et bdo vers e Eden 15 Third party GssessOFs zc idera ee ie S nee E Ne Dt ER E RE e RH UEU Hagen A RE egeo dn 15 A transparent SYSTEM M 15 DECLARATIONS OF CONFORMITY diinteri areae oaa aeaaea Ea possis roras aen SEE NEE RE ennt inserieren enne 15 TECHNICAL INFORMATION sseseseseceesesorsesesescesoroesesesecoesosoesesececoesoroesesecoeeesoroeseseeoeeosoesese 16 SPECIFICATIONS COMPARISON ertoe orere iorn EEEE EEE EEEE EER E E tree teen 16
6. done by using a number of 1 Hz stimulations 10 Technical Manual TOF Watch TOF Watch S and TOF Watch SX 7 Error messages s LI Flashing acceleration transducer Transducer signal unstable too low too high This error can only happen when the TOF Watch is being calibrated or when the read out exceeds 140 Transducer signal too low e first check the movement of the thumb is it moving and what is the direction e then make sure the transducer s movement is perpendicular to the thumb movement furthermore the transducer should not be positioned too high since the end of the thumb is not always vertical but often bents horizontally e check the stimulation current and adjust if necessary e for neonates and infants it is possible that the thumb movement is not sufficient a spatula could be used to extend the thumb the transducer installed at the end of the spatula Transducer signal too high e the movement of the thumb is too high the transducer should be positioned nearer to the thumb base e thethumb is hitting something large deceleration Transducer signal unstable e is the transducer fixed properly e external movements could have moved the hand e the thumb should be moving freely the remaining fingers should be well taped away Flashing Oord 7 surface needle electrode connection Means missing or bad surface or needle electrode connection The cable may be defect How to test if the cable is
7. issuing authority may demand a Service Manual The data in this section allow every company to compile easily its own Service Manual Although requirements differ in each market it may be advisable to include following items 1 Declaration of conformity Product leaflet Warranty information Test procedure description Short setup procedure description Error messages list Cleaning advise TOF Watch TOF Watch S and TOF Watch SX package and accessories list 2 Warranty The TOF Watch TOF Watch S and TOF Watch SX are guaranteed for 1 year a period of 13 months from date of shipment by N V Organon International As the TOF Watch TOF Watch S and TOF Watch SX are a non serviceable device no repairs will be made a defective instrument will simply be replaced free of charge Warranty towards the end user is a matter to be handled by the national company or the distributor It may be advisable and or compulsory to notify the customer of the conditions of the warranty ON g9 c RB c M Technical Manual TOF Watch TOF Watch S and TOF Watch SX I General information on devices 1 List of sales packages and accessories See Appendix VI 1 TOF Watch devices and accessories Technical Manual TOF Watch TOF Watch S and TOF Watch SX 2 Power supply a General The use of a good quality alkaline 9 Volt battery is recommended The battery is not included in the sales package Initial tests show a life span of approximately 200
8. medical devices from syringes and blood bags to drug delivery systems and monitoring equipment and classifies devices into groups according to the risk to the patient involved with any potential failure of the device Class is the lowest category and is for the least risk carrying devices with non sterile non measuring functions and Class III covers the highest risk categories with complex functions such as drug delivery systems b Third party assessors Although some devices in Class are approved and awarded the CE mark on the responsibility of the manufacturer devices covering more critical areas have a more rigorous approval procedure compliance is considerably more demanding and requires external validation All third party assessors called Notified Bodies must adhere to regulations specified in the directive for which they are appointed and can only be appointed to such a position after gaining approval from their governments under the directive A Notified Body must be a registered company within the EEA and gain approval from its own government to become a Notified Body A Notified Body must be independent and have the expertise impartiality and integrity to do the job required of it The directives lay down stringent criteria for the appointment of these bodies and for their regular inspection by their governments Manufacturers can gain third party approval from any of the Notified Bodies and once established a Notified B
9. voltage also decreases gradually 9 Check that there is no read out of acceleration transducer signal when the acceleration transducer is kept complete still during stimulation and that a reading is present if the acceleration transducer is shaken during a stimulation Connect a 1000 Ohm 1 resistor to the LA stimulation cable and connect an oscilloscope across the two terminals of the resistor Connect the LA stimulation cable to the TOF Watch 10 Adjust the current setting to the maximum current 6 mA and start a 1 Hz stimulation Check by means of the connected oscilloscope that the peak to peak voltage across the 1000 Ohm resistor is equal to 6 Volt tolerance 10 Check that the pulse width of the stimulation pulse equals 40 uS tolerance 15 measured from 50 to 50 11 Decrease the stimulation current gradually and see that the amplitude of the stimulation voltage also decreases gradually The results of the above described tests must be recorded see from on next page and filed device record If any of the above tests cannot be successfully passed must the device be repaired or the user of the device must be notified that the functionality and or safety of the device are impaired 18 Technical Manual TOF Watch TOF Watch S and TOF Watch SX C Technical check record form Manufacturer Model TOF Watch Organon Ireland Ltd Drynam Road Swords SN Co Dublin Ireland Distributor Functional an
10. TOF Watch S and TOF Watch SX Ill Regulatory information 1 GENERAL INFORMATION Organon Ireland Limited is EN ISO 13485 certified for medical devices All TOF Watch devices comply with world wide registration requirements including FDA and CE Medical Device Directive MDD rules The TOF Watch devices are classified as Class IIA devices by EU MDD and as Class II by FDA The CE certificate is in accordance with the requirements of Annex V section 3 2 Production Quality Assurance of Council Directive 93 42 EEC concerning Medical Devices The TOF Watch devices comply amongst others with EN 60601 1 Electromedical devices General Safety IEC 601 2 10 Particular requirements for the safety of nerve and muscle stimulators EN 60601 1 2 Electromedical devices Electromagnetic Compatibility Complete registration information and documentation file is available at the Global Regulatory Affairs department 2 ONCE Marking From June 13 1998 all medical devices sold in the European Economic Area EEA have to carry a CE mark On January 1st 1995 new regulations were brought into being European Medical Devices Directive 93 42 EEC establishing standards for the approval and monitoring of medical devices covering all aspects from design and clinical investigation to manufacturing and post market surveillance These regulations have replaced existing not only regulatory requirements in individual countries and establish a pan Eur
11. USA www schering plough com
12. ation room OR or intensive care unit ICU before connection and initiation a 1 For surface stimulation 1 Check that the surface electrode current is above 10 mA or 2 0uC Short circuit the electrode connectors Start a 1 Hz repetitive stimulation and see that no errors occur Boo m If acceleration transducer is present shake the transducer and observe random changing percent 96 readouts in display 5 Open the electrode short circuit and observe that the TOF Watch S SX stops the current stimulation flashes bad surface electrode connection symbol in the display and gives a double beep a 2 For needle electrode stimulation loco regional anesthesia 1 Check that the needle electrode current is above 1 mA or 0 04uC Short circuit the electrode connectors Start a 1 Hz repetitive stimulation and see that no errors occur Boom Open the electrode short circuit and observe that the TOF Watch S SX continues stimulation and gives a double beep each time stimulation is carried out the bad needle electrode connection symbol is flashing in the display 17 Technical Manual TOF Watch TOF Watch S and TOF Watch SX b Technical check procedure If regular checks of neuromuscular monitoring devices are required within national legislation is it recommend that these checks be carried out at an annual basis at least The person carrying out a check shall by means of his education knowledge and practical experience be qualifie
13. c calibration on patients already relaxed will result in incorrect selection of internal gain due to fading 1 3 4 Place electrodes in position attach the acceleration transducer to the thumb with adhesive tape perpendicular to the direction it moves Turn on the TOF Watch S SX by pressing the ON OFF button and holding it down for 1 second Adjust the stimulation current by pressing the mA uC up or down arrow buttons Press the TOF button and hold it down for 1 sec to obtain repetitive TOF stimulation Since no control twitch height has been established the response to single twitch cannot be used to measure patient relaxation Therefore only the TOF ratio informs about the recovery of a patient Technical Manual TOF Watch TOF Watch S and TOF Watch SX 6 CALIBRATION With the TOF Watch S SX in stop mode pressing down the CAL button for more than one second starts the calibration sequence a TOF Watch Calibration sequence Ten ST stimulations are performed the first 7 stimulations are used to set the gain in the acceleration circuit the last 3 ones are used to check the stability of the signal If the response of the transducer is not adequate at standard gain the gain is changed If the response with the highest gain remains insufficient within the first 7 stimulations the signal is too low see the Errors section Calibration is stopped and the transducer symbol flashes in the display If the transducer respon
14. cturer the authorised representative the notified body if applicable the product and where appropriate a reference to harmonized standards or other normative documents 15 Technical Manual TOF Watch TOF Watch S and TOF Watch SX IV Technical information 1 SPECIFICATIONS COMPARISON The table below gives a quick overview and comparison between the functions of the TOF Watch TOF Watch S and TOF Watch SX X see P button X see P button X TOF stimulation programmable 1 60 min repetition time P user programmable button yes functions programmable DBS TET OFF Stimulation current range impedance cera pc ae Calibration of acceleration transducer 1 mode auto 2 mode auto 2 mode auto sensitivity User programmable TOF amp TOF alarms 2 upper amp lower limits OFF count or TOF Automatic power switch off after 2 hours of no operation Surface temperature sensor 20 E T Fiber ones line Data dump from device Nerve location LA 1 Hz stimulation Current range impedance 0 6 mA 5 Ko 0 6 mA lt 5 Ko 0 6 mA 5 KO Pulse width 40 us 40 us 40 us 16 Technical Manual TOF Watch TOF Watch S and TOF Watch SX 2 Test procedure a Routine check procedure The TOF Watch S SX is designed with all possible self checking controls to ensure optimum safety However in many hospitals a daily routine is in place to check all monitoring devices in the oper
15. d safety check Tested 6 Functional test ood 8 Current adjustment neuromuscular monitoring 9 Acceleration transducer d 11 Signature stamp 19 Technical Manual TOF Watch TOF Watch S and TOF Watch SX V Other Useful information For further information on service and maintenance please consult the Operating Manuals included in the sales package or contact the Marketing Anesthesia of Schering Plough 20 Technical Manual TOF Watch TOF Watch S and TOF Watch SX VI APPENDIX 21 Technical Manual TOF Watch TOF Watch S and TOF Watch SX 1 22 TOF Watch devices and accessories Content Organon article no 79950219 Product description Negative stimulation lead 5 pcs Positive stimulation lead 5 pcs Acc transducer lead TOF Watch TOF Guard Main TOF Watch cable Local anesthesia cable for TOF Watch Thumb adapter acceleration transducer 50 pcs Eye adapter acceleration transducer 50 pcs TOF Watch IV Pole clamp Battery lid for TOF Watch 25 pcs Hand adapter for acc transducer Strap for Hand adapter 10 pcs Electrodes Neotrode 3 x 100 pcs Complete TOF Watch SX cable Thermistor lead 5 pcs TOF Link USB sales package TOF Link cable 3 m TOF Link cable 0 25m TOF Watch SX Interface RS232 adapter Technical Manual TOF Watch TOF Watch S and TOF Watch SX a Devices ART NO DESCRIPTION 79950161 TOF Watch 1 Instructions for us
16. d to carry out such work 1 Check the overall condition of the instrument for mechanical defects which might influence on the performance and safety of the device 2 Checkthe overall condition of the accessories for mechanical defects which might influence on the performance and safety of the device 3 Check that the user manual device record are available and in such a condition that the proper use of these are possible 4 Check that relevant safety information on the device labeling is readable 5 Checkthat the condition of the used battery is sufficient to carry out normal operation of the device Connect a 1000 Ohm 1 resistor to the surface electrode stimulation cable and connect an oscilloscope across the two terminals of the resistor Connect the surface electrode stimulation cable and the acceleration transducer cable to the TOF Watch 6 Switch the device ON and check that all functions and associated display information are functional and as described in the user manual 7 Adjust the current setting to the maximum current 60 mA and start a 1 Hz stimulation Check by means of the connected oscilloscope that the peak to peak voltage across the 1000 Ohm resistor is equal to 60 Volt tolerance 10 Check that the pulse width of the stimulation pulse equals 200 uS 300 uS tolerance 15 measured from 50 to 50 8 Decrease the stimulation current gradually and see that the amplitude of the stimulation
17. des the use of the PTC button for 2 minutes after successful operation of PTC or TET If activated before the time out period has expired an attention beep will sound If no other stimulation is running device in stop mode PTC will be shown flashing for 5 seconds TET flashing Till 2 minutes after a TET or PTC stimulation the use of TET is excluded If activated before the time out period has expired an attention beep will sound If no other stimulation is running device in stand by mode TET will be shown flashing for 5 seconds Battery Empty Low Replace the battery by a new 9V high quality alkaline or NiCd nickel cadmium battery Notice that when switching the TOF Watch on and prior to every stimulation the battery voltage is measured Internal Error The self tests have detected an error in the device 12 Technical Manual TOF Watch TOF Watch S and TOF Watch SX 8 Cleaning advice for TOF Watch S SX The TOF Watch S SX case overlay and display may be cleaned with a damp cloth mild cleaning agents or alcohol can be applied to above mentioned parts Thorough cleaning of the device can be achieved by using a cloth moistured with either 7096 ethanol methanol a chlorohexidine solution or 0 596 hypochlorite Other chemical cleaners may damage the case finish and are not recommended Do not use abrasive cleaners as these will damage the surface Do not allow liquid to enter the case 13 Technical Manual TOF Watch
18. e 1 TOF Watch 1 TOF Watch Patient cable 79950214 79950160 TOF Watch S Containing 1 Instructions for use 1 TOF Watch S 1 TOF Watch Patient cable 79950214 PICTURE 23 Technical Manual TOF Watch TOF Watch S and TOF Watch SX ART NO DESCRIPTION 79950162 TOF Watch SX Containing 1 Instructions for use 1 TOF Watch SX 1 TOF Watch SX Patient cable 79950213 79950157 TOF Watch SX interface Philips Containing 1 Instructions for use 1 TOF Watch SX 1 TOF Watch SX Patient cable 79950213 1 TOF LINK RS 232 interface 1 TOF LINK interface cable 0 25 m 79950208 PICTURE 24 Technical Manual TOF Watch TOF Watch S and TOF Watch SX b General accessories ART NO DESCRIPTION 79950074 Negative stimulation lead 5 pcs Part of all TOF Watch sales packages and TOF Watch complete cables 79950075 Positive stimulation lead 5 pcs Part of all TOF Watch sales packages and TOF Watch complete cables 79950163 TOF Watch SX TOF Guard acceleration transducer Part of all TOF Watch sales packages and TOF Watch complete cables PICTURE 25 Technical Manual TOF Watch TOF Watch S and TOF Watch SX ART NO PICTURE DESCRIPTION 79950215 TOF Watch main cable Part of all TOF Watch sales packages and TOF Watch complete cables 79950006 Stimulation cable 1 5 m for needle electrode LA One lead to be connected to a s
19. ead 79950074 1 Positive stimulation lead 79950075 1 acceleration transducer 79950163 29 Technical Manual TOF Watch TOF Watch S and TOF Watch SX d Accessories for TOF Watch SX ART NO PICTURE DESCRIPTION 79950213 TOF Watch SX complete cable Part of article number 79950162 and 79950157 Containing 1 TOF Watch main cable 79950215 1 Negative stimulation lead 79950074 1 Positive stimulation lead 79950075 1 acceleration transducer 79950163 1 TOF Watch SX thermistor 79950151 79950151 TOF Watch SX thermistor 5 pcs Part of article number 79950162 and 79950157 1 pcs 30 e TOF Link and accessories ART NO PICTURE DESCRIPTION 79950155 TOF LINK USB interface incl TOF MONITOR program Optical to USB adapter cable and TOF Watch SX Monitor program facilitates online TOF Watch SX data capture on a Computer desktop or laptop Containing 1 CD with TOF Watch SX Monitor program 1 TOF LINK USB interface 1 TOF LINK interface cable 3m 79950154 79950154 TOF LINK interface cable 3 m Part of article number 79950155 79950208 TOF LINK interface cable 0 25 m Part of article number 79950157 31 32 ART NO DESCRIPTION 79950219 TOF Watch SX Interface RS232 adapter Part of article number 79950157 PICTURE NOTES 33 Schering Plough Corporation 2000 Galloping Hill Road Kenilworth N J 07033 0530
20. hours with a 400 mA battery of continuous stimulation under worst conditions surface electrodes 5 kOhm 60 mA 1 Hz stimulation When the battery is replaced the setup values will not be lost The default settings are stored in an EEPROM This Electrical Erasable Program Read Only Memory stores the setup values for a minimum of 10 years b Battery Warnings The battery is tested when the TOF Watch S SX is powered on and before every stimulation either user stimulation or self test stimulation b 1 Battery low This warning advises the user to change the battery before next operation If battery low is detected the battery low symbol will flash for 1 min and thereafter be shown steady Any ongoing stimulation will continue The symbol will be shown until the device measures a battery voltage exceeding 8 5 V when a new battery has been inserted b 2 2 Battery empty This warning advises the user that the TOF Watch S SX cannot function due to the condition of the battery If an empty battery is detected the TOF Watch S SX stops any stimulation and will show the battery empty symbol together with Err From this state it is only possible to turn off the device If it is turned on again without changing the battery the TOF Watch S SX continues to show the same display The battery empty warning will only be removed when battery level is exceeding 8 5 V when the TOF Watch S SX is switched on when a new battery has been in
21. ody can operate anywhere in the world Where a notified body is involved in the production control phase according to the applicable directives its identification number most follow the CE marking The manufacturer or the authorised representative established in the Community affixes the identification number under the responsibility of the notified body c A transparent system These new directives cover all aspects of the device from gaining pre market approval to in use monitoring There is even incident monitoring with requirements placed on manufacturers to report incidents associated with fault or failure of a device which could cause or did cause serious injury or death Such an incident is required to be reported to the government of the country in which it occurred It is anticipated that these directives will offer an open and transparent system of approval and monitoring of medical devices and should help to ensure that standards are maintained throughout Europe regardless of the country or area of use 3 Declarations of conformity Declaration of Conformity The manufacturer or authorised representative established within the Community must draw up an EC declaration of conformity as part of the conformity assessment procedure provided for in the New Approaches Directives The EC Declaration of Conformity should contain all relevant information to identify the Directives according to which it is issued as well as the manufa
22. opean system for regulating devices to ensure the same high degree of protection for patients wherever they live It applies to all medical devices sold in the EEA regardless of their country of origin Manufacturers must ensure that products meet specific requirements gaining third party approval in the case of the more complex devices and affix the CE mark to confirm that a product meets the required standards Using different requirements for products that are placed on the European market hinders the free movement of goods and services within the EU In order to avoid these problems the new approach directives have been established Harmonized standards have to be used to avoid re inspection and the trade barriers in the different countries The Medical Device Directive MDD is such a new approach directive that impose essential requirements on products concerning safety health environmental and consumer protection To show that a product complies with the new approach directive the CE mark is fixed CE stands for Conformit Europ enne The period between January 1 1995 and June 13 1998 was the transitional period giving the manufacturers and importers time to set in place the procedures for the new directives During this time manufacturers could choose to comply with either the old or the new regulations 14 Technical Manual TOF Watch TOF Watch S and TOF Watch SX a Establishing standards The new directive encompasses all
23. se with the lowest gain is above the given range within the first 7 stimulations the transducer signal is too high see the Errors section Calibration is stopped and the transducer symbol flashes in the display If the acceleration response lies within the range after the first 7 stimulations the next 3 stimulations are used to evaluate the stability of the signal If unstable see the Errors section calibration is stopped and the transducer symbol flashes in the display If the transducer response is acceptable the calibration is terminated and the calibration symbol inverted triangle in the display indicates a successful calibration The calibration is advisable when 1 ST stimulation is to be used without a reference value the TW 96 doesn t provide objective information 2 the transducer signal is expected to be small e g in children or when monitoring the Orbicularis Occuli muscle b TOF Watch S SX Calibration sequences C Calibration sequence 1 Calibration of acceleration transducer sensitivity at user set current charge 200 or 300 us pulse width by using minimum 5 sec of single twitch stimulation with 500ms repetition rate 2Hz Identical to current calibration sequence in TOF Watch d Calibration sequence 2 Determination of supramaximal stimulation threshold at 200 or 300 us pulse width followed by calibration of acceleration transducer sensitivity at threshold 10 at same pulse width Both are
24. serted Technical Manual TOF Watch TOF Watch S and TOF Watch SX 3 TOF Watch S SX Cables a Insertion and recognition To prevent wrong insertion of the cables stimulation and acceleration these are mechanical coded Only the right plug fits into the designated outlet The TOF Watch can detect if a cable is inserted and which type is inserted This feature is integrated by an electrical coding in the plugs of the individual cables When the LA cable is connected to the device the TOF WATCH automatically switches to low current mode b Strength The stimulation cables are of the tensile cord type Tensile cords are cables in which there individual wires strands in each conductor are not round as usual but flat squared wires These are wound around a core thread of non conducting type This design makes the cable very flexible and is very resistant to bending wrinkling and strain The cable used for the acceleration transducer is also of a special type It tolerates a lot of bending and wrinkling In spite of the small diameter the transducer cable can tolerate a strain load without being damaged This is of course not true for the transducer cable connection 4 Keyboard The keyboard and overlay are not constructed as a conventional membrane keyboard but as separate elements The construction consists of individual switches mounted on the PCB and a separate protective overlay mounted on the enclosure of the instrument
25. urface electrode and the 2 mm diameter banana to be connected to a Local Anesthesia needle 79950152 Thumb adapter acceleration transducer 50 pcs For attaching the acceleration transducer to the thumb without plaster Using this adapter avoids damage to the cable when detaching the cable 26 Technical Manual TOF Watch TOF Watch S and TOF Watch SX ART NO PICTURE DESCRIPTION 79950207 Eye adapter acceleration transducer 50 pcs For attaching the acceleration transducer to the orbicularis oculi or corrugator suppercilii Box of 50 pcs eye adapter includes 50 pcs ready to use double sided adhesives 79950014 Mounting bracket clamp for IV pole Fits all TOF Watch devices 79950216 Battery lid for TOF Watch 25 pcs 27 Technical Manual TOF Watch TOF Watch S and TOF Watch SX ART NO DESCRIPTION 79950209 Handadapter for acceleration transducer Containing 1 Handadapter 2 Straps for handadapter 79950014 79950217 Strap for Handadapter 10 pcs Part of article number 79950209 2 pcs 79950039 Electrodes Neotrode 3 x 100 pcs 28 PICTURE Technical Manual TOF Watch TOF Watch S and TOF Watch SX c Accessories for TOF Watch TOF Watch S ART NO PICTURE DESCRIPTION 79950214 TOF Watch complete cable Part of article number 79950161 and 79950162 Containing 1 TOF Watch main cable 79950215 1 Negative stimulation l
Download Pdf Manuals
Related Search