PDF Manual - Integramouse
Contents
1. e During highly infectious diseases the mouthpiece must only be used once The interval between changes of the mouthpiece must be determined by a doctor or an expert advisor e Take regular breaks when you are working with computers Physical signs of tiredness include eye pain neck stiffness and other accompanying signs A ten minute break per hour of work is recommended e The device must not be used in atmospheres enriched with oxygen or other combustible gases 5 SCOPE OF SUPPLY O1 GEBRAUCHEAMMVEISL IntegraMouse PLUS After opening the packaging please check the delivery for completeness and check whether the IntegraMouse Plus or the accessories show any sign of damage or defects If this is the case contact your dealer immediately Figure 1 Scope of supply LIFEtool article number Quantity Description Ki a LIFEtool IntegraMouse Plus MELLE 2 LIFEtool IntegraMouse Plus Connect IM Connect 11211 LIFEtool IntegraMouse Plus mouthpiece a LE nein en EEE a ES ER i 6 PRODUCT DESCRIPTION 6 1 Components and operating elements 1 IntegraMouse Plus 2 Mouthpiece with membrane 3 Silicon tube 4 IM Connect Figure 2 Components of the IntegraMouse Plus Figure 3 Operating elements on the IntegraMouse left and IM Connect right 1 ON OFF key and calibration Battery power display Joystick mode display J Analogue joystick with key 1 and key 2 Cursor mode displ2. LIFEISSI SOLUTIONS INSTRUCTIONS FOR USE Version 1 2 integraMouse Plus including accessories DEAR CUSTOMER Thank you for choosing a LIFEtool product and for choosing to use the IntegraMouse Plus as a valuable input device for your computer These instructions for use contain useful and important information Please read this manual carefully before using IntegraMouse Plus for the first time LIFEtool and your authorised IntegraMouse dealer will be happy to answer your questions We wish you every success with your IntegraMouse Plus Contents Tes GOMAC POPRRGBERSDEHBERGBEREBEBDUEREERVEERDBEECHERSEEREUENEREESHERSBELOUERSBEENULHEREFUREEERREUEBEREEEULEEREROREERBRESUEILBERSURRR 4 25 NOLES On Me INSIUCHONS TOUSE nee 4 3 Product information and use as per regulations ccccccccseeeeeeeeeeeeeeeeeeeseeeeseeeeseeeeneeeesees 5 7s ramos 21 AV Kod 1 9 Lom eed ee 6 9s SCOPE OF SURpWVee nee 7 Gx SPIOQUELDESENPUON EEE 8 6 1 Components and operating elements 224u0224002000000nn nenne nenn nenne nenne nenne nennen 8 6 2 Accessories And spare DANS aan een ar 10 Te COMMS SO MMA ct nak ct a eth ete 12 7 1 SN rt introauctionTto ntal peration zus 12 fae GenetallAstallati n notes a sesusenasunesnn us 12 7 3 SWILCHINg On and aclvalngzeeiseeselenislenlelteielinielieielunelieie 14 71 4 Valbral hss 222 2s 2er 15 7 5 Using the IntegraMouse Plus silicon tube 2uu022000200000n0nn
3. 21 9 HYGIENE MAINTENANCE AND TESTING In order to guarantee the long and safe operation of the IntegraMouse Plus the following activities are necessary e Regular cleaning and regular changing of the mouthpiece e Regular changing of the membrane e Regular cleaning of the device e Regular proper charging of the battery in wireless mode e Regular metrological testing and maintenance e General care when dealing with the individual components The individual points are described below in more detail In the case of errors or problems with the IntegraMouse Plus do not try to repair the product or its accessories This can invalidate the guarantee and severely damage the device Always contact the manufacturer or your dealer O The life expectancy of the IntegraMouse Plus has been set by the manufacturer at 5 years from the date of manufacture see the serial number of the device After this date no service can be guaranteed 9 1 Cleaning the mouthpiece and changing the membrane Two mouthpieces are included with the IntegraMouse Plus in order to ensure regular cleaning without interrupting use d The replacement and subsequent cleaning of the mouthpiece should be carried O out in the home about once per week In the case of higher levels of contamination or in the case of illness more frequent cleaning is recommended If there is visible damage or there are signs of wear and tear on the mouthpiece use a new mouthpiece
4. CONTACT wf MANUFACTURER S ADDRESS LIFEtool Solutions GmbH Hafenstra e 47 51 A 4020 Linz AUSTRIA INTERNET www integramouse com 2 NOTES ON THE INSTRUCTIONS FOR USE Please read these instructions for use completely before first use and keep them for reference for later use The triangle symbol indicates warnings i e when failure to follow the instructions may result in hazardous situations O The information symbol indicates general notes and information The symbol with the snake on a green star indicates subject specific information e g for medical personnel or hospital visitors Instructions for use are valid for the IntegraMouse Plus device version and its specific accessories Issue date 2012 09 Technical changes reserved 3 PRODUCT INFORMATION AND USE AS PER REGULATIONS IntegraMouse Plus is a medical product made using the latest technology It complies with European standards and harmonised norms that are based on the Medical Device Directive and has therefore been awarded the CE mark Details of this can be found in Chapter 17 Declaration of Conformity IntegraMouse Plus is a fully adequate computer mouse that is operated with the mouth For the operation of computer games a joystick mode and a cursor mode are provided This allows persons who are no longer able to operate a traditional mouse to use a computer According to the Medical Device Directive IntegraMouse Plus compensates for
5. swallowing such objects Danger of suffocation 16 8 APPLICATION AND FUNCTIONALITY The IntegraMouse Plus is an input device for your computer The input device works as a standard computer mouse mouse mode or optionally as a joystick joystick mode or as a keyboard cursor mode Movements of the mouthpiece by the mouth are captured by a sensor A small deflection of the mouthpiece is enough to cause the controller to respond As well as movement sucking and blowing on the mouthpiece are also used for input e g left and right mouse click N Only put the mouthpiece so far into your mouth that your teeth reach the groove on the mouthpiece If you have put the silicon tube on ensure that it is seated securely and only put the mouthpiece so far into your mouth that you cannot extend your lips and teeth over the silicon tube 8 1 Switching on the IntegraMouse Plus The IntegraMouse Plus can be switched on in the following ways e Plug in the live USB cable or ensure a power supply via USB switching on the computer e Plug in the power pack and connect to the mains e Hold the ON OFF button for at least 300 ms During switching on the IntegraMouse Plus is calibrated all LED displays light up one after the other as running lights The IntegraMouse Plus is then in mouse mode f The IntegraMouse Plus must not be moved during calibration During the running light sequence you can also recognise possible defective LEDs
6. 5000 Lux The room installation must comply with the relevant regulations in Austria OVE EN1 OVE ONORM E8001 OVE EN7 OVE ONORM E8007 as relevant Storage conditions Ambient temperature 5 C to 45 C Rel humidity 20 to 80 with no condensation Atmospheric pressure 750 mbar to 1080 mbar Always keep the device in the undamaged original packaging After storing for a long time it may be necessary to recharge the battery and disinfect the device Ensure that no mechanical influences weighing down by other objects shaking etc occur during storage Transport conditions Ambient temperature 5 C to 55 C C Rel humidity 20 to 80 with no condensation Atmospheric pressure 750 mbar to 1080 mbar Transport is carried out in the original packaging Ensure that no mechanical influences weighing down by other objects shaking etc occur during transportation 29 12 WASTE DISPOSAL The IntegraMouse Plus is to be disposed of according to Directive 2002 96 EC WEEE Waste Electrical and Electronic Equipment as an old electrical and electronic device valid in the European Union and other European countries with separate waste disposal systems be treated as household waste Instead this product should be brought to the designated disposal point for the recycling of electrical and electronic devices If the product is properly disposed of you help to avoid negative influences on the environment and harm to health wh
7. as these will not light up 8 2 Three operating modes Mouse Joystick Cursor The active operation mode is shown by blue LEDs on the front of the IntegraMouse Plus see table 1 The display LED for joystick mode is marked with J the one for cursor mode with C If one of the two LEDs is lit the relevant mode is active If neither of the LEDs is switched on the mouse mode is active LED J LED C Mode gt Z o S Joystick mode Table 1 Diagram of the operating modes 17 After plugging in and activating the IntegraMouse Plus is automatically in mouse mode Mouse mode mouse function Small movements of the mouthpiece cause the mouse pointer on the screen to move correspondingly In the same way as a normal computer mouse it can be moved across the screen in a continuous and dynamic way from very slowly to very quickly and placed accurately to the pixel To steer the mouse pointer place the mouthpiece between your lips and press it with lip movements in the desired direction in which the mouse pointer should move across the screen The mouse buttons are activated by sucking and blowing In the standard configuration the left mouse button Is activated by short sucking on the mouthpiece opening and the right button is activated by short blowing on the mouthpiece opening Two short sucks equate to a double click of the left mouse button A short suck and holding the air in the mouthpiece enables objects to be moved acr
8. disabilities to enable the operation of a computer Possible users are persons with high level paraplegia with arms amputated on both sides or advanced diseases such as muscular dystrophy amyotrophic lateral sclerosis or multiple sclerosis IntegraMouse Plus is connected to the computer by a USB cable and Is Plug and Play capable i e it is recognised and installed completely automatically as a Human Interface Device HID Power is also supplied via the USB cable Alternatively the IntegraMouse Plus can communicate with the computer via a wireless radio link connection in the 2 4 GHz ISM Band With this option the power is supplied from the inbuilt battery or the power pack included IntegraMouse Plus is mainly designed to be used in dry rooms in stationary settings on a PC or laptop These include living rooms clinics rehabilitation centres institutes schools universities and similar However usage in dry outside areas i e on patios is also possible The ambient temperatures during application must be between 10 C and 40 C Avoid direct sunlight The placing and positioning of the IntegraMouse Plus must not be changed during use tilt etc Also the IntegraMouse Plus must not be influenced by external forces for example accelerations The mouthpiece can be changed Cleaning is possible according to Chapter 9 Hygiene maintenance and testing In clinical areas the one time use of the mouthpiece is strongly recommended Th
9. modes are switched through in turn Mouse mode Joystick mode Cursor mode j Figure 9 Sequence of the operating modes In quick succession 2 blows 2 sucks 1 blow j Sucking blowing combination for a change of modes by the user p The modes can only be used one after another not at the same time The O operation of programmes which require the use of several input devices e g games with keyboard and joystick is only possible if the input devices are not used at the same time Overview of the assignment of the actions in the relevant modes The standard assignments in the relevant modes can be seen in this table Mouthpiece action Joystick mode Mouse pointer goes up Arrow up Movement down Mouse pointer goes Joystick down Arrow down down Movement left Mouse pointer goes left Joystick left Arrow left right Sucking Left mouse button Button 1 Space key Right mouse button Button 2 Enter or Return Table 2 Standard assignments in the relevant operating modes Combined movements are also possible e g diagonals 20 8 3 IntegraMouse Plus energy saving mode In order to save power during battery operation the IntegraMouse Plus has an in built energy saving mode This begins automatically when e the device is not used for 30 seconds e the computer to which the IntegraMouse Plus is connected goes into standby mode Energy saving mode ends automatically when e the user moves the mouthpiece or quick
10. of the test level Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the IntegraMouse Plus and its accessories requires continued operation during powermains interruptions it is recommended that the IntegraMouse Plus and its accessories be powered from an uninterruptible power supply or a battery The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low 36 Guidance and manufacturer s declaration electromagnetic immunity The IntegraMouse Plus and its accessories are intended for use in the electromagnetic environment specified below The customer or the user of the IntegraMouse Plus and its accessories should assure that they are used in such an electromagnetic environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the IntegraMouse Plus and its accessories including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1
11. 2VP 150 kHz to 80 MHz Conducted RF d 1 2VP 80 MHz to 800 MHz IEC 61000 4 6 3 V m 80 MHz to 2 5 GHz d 2 3VP 800 MHz to 2 5 GHz Radiated RF where P is the maximum output power rating of the IEC 61000 4 3 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 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol R NOTE 1 At 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 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 IntegraMouse Plus and its accessories are used exceeds the applicable RF compliance level above the IntegraMouse Plus and its accessories should be observed to verify normal operation If abnormal performance is observed addition
12. Etool SPARE PART IntegraMouse Plus power pack 11 7 COMMISSIONING 7 1 Short introduction to initial operation e Install the mounting system recommended by LIFEtool or by your LIFEtool dealer on your desired workstation Carefully place the mouthpiece and membrane on the IntegraMouse Plus Position the IntegraMouse Plus on the stand The bracket of the IntegraMouse Plus has three openings for left right and bottom mounting e Move the device into a working position which is balanced and comfortable for the user e For initial use we recommend operation with the cable connected in order to guarantee the charging of the internal battery For this connect the IntegraMouse Plus to your computer via the USB cable supplied e The IntegraMouse Plus switches on automatically and the calibration process is shown through the running LEDs fy Do not move the IntegraMouse Plus during calibration e he operating system of your computer automatically recognises and installs the IntegraMouse Plus as a standard mouse e After the installation has been completed the IntegraMouse Plus is ready for use Detailed instructions on initial operation and use can be found on the following pages In addition you can watch training videos for operation at www youtube com enter keyword IntegraMouse 7 2 General Installation notes The IntegraMouse Plus and also the IM Connect are Plug and Play capable and function with standard USB
13. N ISO 10993 1 2009 EN ISO 10993 10 2009 EN ISO 10993 12 2009 EN ISO 14971 2007 EN 62304 2006 EN 62366 2008 Wir erkl ren in alleiniger Verantwortung dass das oben beschriebene Produkt und Zubeh r in der gelieferten Ausf hrung den Anforderungen der Richtlinie 93 42 EWG und den sterreichischen Medizinproduktegesetzes BGBl 657 1996 i d g F entsprechen Die Produkte werden mit der CE Kennzeichnung versehen We declare under sole responsibility that the product including accessories described above as delivered are in compliance with directive 93 42 EEC and the Austrian medical device law BGBl 657 1996 in the presently valid edition The products are CE marked Linz 09 12 2011 S Gdseh ftsf hre MCES LifeTool Solutions GmbH A 4020 Linz Hafenstr 47 51 Tel 43 0 732 9015 5270 Fax 5271 offica lifetool solutions at www lifetool solutions at 39
14. according to the Medical Devices Operator Ordinance and the relevant Standards e g EN 62353 Responsibility for compliance lies with the operator of the IntegraMouse Plus 26 10 PERMISSIBLE SYSTEM The IntegraMouse Plus is intended for use as an input device for a computer PC or laptop Please only use the USB cable supplied or work in wireless mode Please ensure that your computer or laptop and all other devices which are connected to it printer etc comply with the relevant regulations EN 60950 In rooms used for medical purposes regulations to protect the patients area must be adhered to The patients area is defined as an area of 1 5 meters around the user see figure 15 Within this area only medical products may be used The IntegraMouse Plus and its accessories are medical products The computer is usually office equipment however it can also be a special Medical Computer The following possibilities apply 1 Computer within the patients area o Medical Computer according to EN 60601 1 and EN 60601 1 1 o Computer according to EN 60950 with an optional limit on touch current through the application of an additional protective earthing or an isolating transformer 2 Computer outside of the patients area o Use of wireless mode and ensuring observance of the patients area o Computer according to EN 60950 with an optional limit on touch current through the application of an isolating transform
15. al measures may be necessary such as re orienting or relocating the IntegraMouse Plus and its accessories Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 37 Recommended separation distances between portable and mobile RF communications equipment and the IntegraMouse Plus and its accessories The IntegraMouse Plus and its accessories are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the IntegraMouse Plus and its accessories can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the IntegraMouse Plus and its accessories as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output u power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz W 800 MHz to 2 5 GHz d 1 2VP d 1 2VP d 2 3VP 12 12 23 face en One se he ee ee ee E ee ee eee For transmitters rated at a maximum output power not listed above the recommended separation distance can be determined using the equation applicable to the frequency of the transmitter where P is the maximum outputpower rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 An additional factor of 10 3 is used in calculating the recommended s
16. and dispose of the old mouthpiece 22 For thorough cleaning disinfection with boiling water thermo disinfection is recommended Then proceed as follows 1 Pull the mouthpiece off forwards in a straight movement Removal is very simple and possible without using larger amounts of force see Figure 10 Figure 10 Removing the mouthpiece 2 Remove the membrane by pushing and dispose of it see Figure 11 Figure 11 Removing the membrane 3 Heat pure clear water and bring it to the boil 100 C 4 Place the mouthpiece carefully into the boiling water In order to do this use an aid e g a spoon 5 When doing this ensure that the mouthpiece is completely covered with water Possible air bubbles on the surface of the mouthpiece also on the inner side must be removed e g by stirring so that the surface is completely covered with boiling water 6 Leave the mouthpiece for at least 3 minutes and ideally 5 minutes in boiling water Ensure that the water temperature does not fall below 93 C 7 Remove the mouthpiece with a tool e g spoon and leave the mouthpiece to drip and dry on aclean surface 8 Before you use the cleaned mouthpiece again ensure that it is completely dry and has cooled to room temperature 23 9 Any limescale can be removed using a soft cloth 10 After drying and cooling place a new membrane on the mouthpiece see figure 12 Ensure that the membrane is properly placed on the mou
17. at the user first of all assumes an ergonomic sitting and working position in front of the screen and that the IntegraMouse Plus is only then brought into the mouth of the user in a fatigue proof working position Ensure that you have enough space in which to work and a good view of the screen Pay attention to your position in relation to sources of disturbance e g dazzling sunlight through windows Lack of ergonomics can lead to eye pain headaches or muscle tension The IntegraMouse Plus can also be used in an inclined or lying position It is important that the calibration e g after plugging in the USB cable only occurs after setting up the workstation You can recalibrate the position at any time by quickly pressing the ON OFF button 13 7 3 Switching on and activating Next you must decide in which operating mode you wish to operate the IntegraMouse Plus e Connected by cable i e directly connected to the computer via USB cable e Wireless transmission with battery powered operation of the IntegraMouse Plus e Wireless transmission with operation of the IntegraMouse Plus via the power pack included IntegraMouse Plus in cable connected mode 1 Connect the IntegraMouse Plus to your computer via the USB cable supplied 2 The IntegraMouse Plus switches on automatically and the calibration process is shown through the running LEDs O If the IntegraMouse Plus is in wireless mode cable connected operation can be initiated d
18. ay C Cursor keys space key and enter key Connect key Standby LED USB port Jack socket enables connection of an external sensor 3 5 mm mono jack for the manual change between the three operating modes mouse joystick cursor CO N O A A W N Figure 4 Reverse side of the IntegraMouse Plus oO All operating elements are latex free and free from poisonous components 6 2 Accessories and spare parts An overview of the technical data can be found in Chapter 15 Product and performance data IntegraMouse Plus Connect IM Connect The IM Connect is plugged into the USB port of the computer and serves as a radio receiver in wireless mode IntegraMouse Plus mouthpiece The mouthpiece is in direct contact with the user s lips and is therefore the applied part The mouthpiece is removable therefore it can be replaced or cleaned separately rt The applied part mouthpiece is of type B IntegraMouse Plus power pack The power pack is used for charging the battery and also for supplying the IntegraMouse Plus with power in wireless mode For safe operation only use this power pack IntegraMouse Plus USB cable The USB cable is used to connect the IntegraMouse Plus with the computer in cable connected mode The internal battery of the IntegraMouse Plus is also charged at the same time For safe operation only use this USB cable IntegraMouse Plus membrane The membrane is necessary for the sucking bl
19. by caretully stretching the membrane with a suitable object e g the top round end of a ballpoint pen However you have the option to connect auto click software or external sensors via suitable switch interfaces in order to activate the left and or right mouse button in an alternative way Your dealer will be happy to advise you about this 30 Can I change the speed of the mouse pointer Yes In the mouse settings options of your operating system Can I change or swap the assignment of the mouse buttons Yes In the mouse settings options of your operating system Can I set the double click speed Yes In the mouse settings options of your operating system Can I write texts with the IntegraMouse Plus Yes Windows 7 for example offers a free on screen keyboard under Start All Programs Accessories Windows Mobility Center Recommendations for more convenient on screen keyboards that are available to buy e g with predictive text can be obtained from your dealer After changing the mouthpiece the mouse pointer can no longer be moved Ensure that the mouse is correctly connected and ready to be used check the LEDs Check that the mouthpiece is in the correct position and recalibrate After changing the membrane the mouse buttons can no longer be activated Recalibrate Check that the membrane is positioned securely and is not damaged After cleaning the mouthpiece cannot be placed on the control unit or is difficult to put o
20. ce off and store it according to Chapter 11 Ambient conditions e Use within strong electromagnetic fields can cause the device to malfunction e The device must not be opened by the user as this would invalidate the manufacturer s guarantee Repairs may only be carried out by the manufacturer or its authorised partners Incorrect handling of the internal battery can especially lead to hazards e Persons who produce a large amount of saliva must not use the IntegraMouse Plus The IntegraMouse Plus may be used in combination with the attached IntegraMouse Plus silicon tube only by such persons that are not in danger of swallowing such objects e The IntegraMouse Plus must not be used on moving systems e g wheelchairs or on systems with changes of position e g changes of inclination The IntegraMouse Plus must not be used for the operation of life supporting or safety devices such as emergency call installations medication dosing apparatus medical expert systems etc e Children under 3 years of age are not permitted to operate the IntegraMouse Plus e The IntegraMouse Plus must not be used in connection with HF surgical units or defibrillators e A combination with other devices than those described in Chapter 10 Permissible system is not permissible Any other combination with medical products or other products leads to the system integrator becoming the system manufacturer and also taking on responsibility for the product
21. cted to the public low voltage power supply Voltage fluctuations network that supplies buildings used for domestic flicker emissions purposes IEC 61000 3 3 35 Guidance and manufacturer s declaration electromagnetic immunity The IntegraMouse Plus and its accessories are intended for use in the electromagnetic environment specified below The customer or the user of the IntegraMouse Plus and its accessories should assure that they are used in such an environment Immunity test IEC 60601 test level Compliance level nn Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst 2 kV for power supply lines 2 kV for power supply lines IEC 61000 4 4 1 kV for input output lines 1 kV for input output lines Surge 1 kV differential mode 1 kV differential mode EC 61000 4 5 2 kV common mode 2 kV common mode 6 kV contact 6 kV contact 8 kV air 8 kV air lt 5 UT lt 5 UT gt 95 dip in UT gt 95 dip in UT Voltage dips short for 0 5 cycle for 0 5 cycle interruptions and 40 UT 40 UT voltage variations 60 dip in UT 60 dip in UT on power supply for 5 cycles for 5 cycles input lines 70 UT 70 UT 30 dip in UT 30 dip in UT IEC 61000 4 11 for 25 cycles for 25 cycles lt 5 UT lt 5 UT gt 95 dip in UT gt 95 dip in UT gt 5s 5s Power frequency 50 60 Hz magnetic field 3 A m 3 A m IEC 61000 4 8 NOTE Uris the a c mains voltage prior to application
22. drives This means that they are automatically recognised and installed by common operating systems after being plugged in The IntegraMouse Plus is thereby automatically recognised as a standard mouse standard joystick and keyboard The installation process usually runs in the background dependant on the operating system Therefore the IntegraMouse Plus is ready to be used after only a short time During initial installation it takes a short time until the IntegraMouse Plus is ready for use When plugging in the IntegraMouse Plus to a computer that Is already known the IntegraMouse Plus is ready for use straight away 12 Installing the IntegraMouse Plus and components Install the stand recommended by LIFEtool or by your LIFEtool dealer on your desired workstation The bracket of the IntegraMouse Plus has three openings for left right and bottom mounting Secure the IntegraMouse Plus on the stand in the intended mounting place with the locknut Figure 7 and then bring the IntegraMouse Plus into the final desired working position Figure 6 Figure 7 Installing the IntegraMouse Plus Figure 6 Correct working position Do not use the IntegraMouse Plus on mobile or moving systems Ensure that the IntegraMouse Plus is positioned away from your face so that no hazards can arise e g by a third person bumping into you Be careful where you place the available cable In order to avoid collisions with the IntegraMouse Plus ensure th
23. e enables the operation of computer games and programmes that can be controlled with the cursor keys arrow keys the space key and the enter key The four eight directions are actuated by the movement of the mouthpiece The space key and the enter key are available through sucking and blowing Activated cursor mode is indicated by the lighting up of the associated blue LED Additional notes apply to all three operating modes O In order to operate a complete keyboard e g in order to enter letters or whole texts to compose e mails and so on the operating system of your computer usually makes an on screen keyboard available Your LIFEtool dealer will be glad to advise you on more powerful on screen keyboards that are available at cost with additional setting options d Many applications especially games can be terminated using the ESC key This O function is also available to users of the IntegraMouse Plus by means of the following sucking blowing combination In quick succession blow for 3 seconds briefly suck 2 x briefly blow 1 x 19 Switching between the modes After plugging in and activating the IntegraMouse Plus is in mouse mode as standard In order to switch between modes you have the following options e By connecting and using an external sensor e By the following sucking blowing combination two quick blows then two quick sucks within 2 seconds and one quick blow within 1 second Through this the
24. eparation distance for transmitters in the ISM frequency bands between 80 MHz and 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 38 17 DECLARATION OF CONFORMITY F LifeTool Solutions GmbH N Hafenstra e 47 51 A 4020 Linz o Ki D AUSTRA Life T ool E office lifetool solutions at W http www integramouse com R Solutions GmbH KONFORMIT TSERKL RUNG DECLARATION OF CONFORMITY Produktspezifikation product details Produktbezeichnung product name IntegraMouse Plus Type type IntegraMouse Plus Systemkomponenten Hauptger t Funkempf nger Mundst ck Membran Netzteil systems components main unit RF receiver mouth piece membrane power supply unit Klassifizierung nach RL 93 42 EWG Anhang IX Klasse nach Regel 5 Classification according 93 42 EEC annex IX Class according rule 5 Konformit tsbewertung assessment details Verfahren nach RL 93 42 EWG Anhang VII Konformit tserkl rung route of directive 93 42 EEC annex VII declaration of conformity Angewandte Normen used standards Harmonisierte Normen harmonized standards EN 60601 1 2006 EN 60601 1 1 2001 EN 60601 1 2 2001 A1 2006 EN 980 2008 EN 1041 2008 E
25. er fA a Figure 15 Definition of the patients area according to EN 60601 1 Computer within the patients area 1 and computer outside of the patients area 2 27 The operator who connects the IntegraMouse Plus to the computer must satisfy the requirements of EN 60601 1 1 and the relevant laws and standards for electrical installation In the case of a connection with devices outside of the same medical rooms it may be necessary to install a means of Isolation into the data line External sensor A suitable sensor can be plugged into the built in 3 5 mm mono jack socket and used for switching between the operating modes mouse joystick cursor mode Only potential free external sensors may be used Ask the manufacturer or your dealer for further information on this Figure 16 External sensor Further medical products in the patients area Basically the use of further medical products in the patients area that are not directly coupled with the IntegraMouse Plus e g ECG breathing apparatus is possible In doing this pay attention in every case to the instructions for use of the other medical product and get orientation from the protective guidelines in Chapter 16 28 11 AMBIENT CONDITIONS Operating conditions Ambient temperature 10 C to 40 C Rel humidity 20 to 80 with no condensation Atmospheric pressure 750 mbar to 1080 mbar Light intensity lt
26. ich could be caused by inappropriate disposal The recycling of material will preserve our natural resources For further information about recycling this product please contact your household refuse collectors the manufacturer or your dealer This symbol on the product or on the packaging means that this product cannot MEN Individual non electric components including mouthpieces silicon tubes and individual membranes can be disposed of with household rubbish Please pay attention to hygienic aspects Contact the responsible authorities for disposal if necessary 13 FREQUENTLY ASKED QUESTIONS AND ANSWERS Do I need specific drivers or software for installation No The IntegraMouse Plus is automatically recognised as a standard mouse or Standard joystick and standard keyboard and installed on your operating system plug amp play for the operating systems Windows XP Windows Vista Windows 7 Linux Max OS X Can I also use the IntegraMouse Plus with Apple or Linux Yes The IntegraMouse Plus can be used with Mac OS X or higher versions The IntegraMouse Plus should work with all Linux operating systems that support USBs do not have the strength required to operate the mouse buttons by sucking or blowing Can I change the sensitivity of the sucking blowing stimuli The necessary sucking blowing stimuli of the IntegraMouse Plus were set by the factory at a particular range and cannot be altered Exertion can be reduced
27. ly presses the ON OFF button do not hold down e apower supplying USB cable is plugged in e the computer to which the IntegraMouse Plus is connected wakes up from standby mode again O Energy saving mode is basically not noticeable to the user because the IntegraMouse Plus activates again immediately on interaction Attention only with movement of the mouthpiece but not sucking or blowing 8 4 Switching off the IntegraMouse Plus The IntegraMouse Plus can only be switched off in active mode LEDs for the battery power display light up If the IntegraMouse Plus is in energy saving mode this can be exited by a short press of the ON OFF key By pressing the ON OFF key for at least 3 seconds the IntegraMouse Plus can be switched off All LEDs on the IntegraMouse Plus go out a When battery power is low the IntegraMouse Plus switches itself off automatically When it is switched off no more energy is needed from the battery 8 5 Wake on USB The Wake on USB function permits the inactive computer to activate the connected IntegraMouse Plus on the USB port This function must be supported by the hardware and by the operating system Further information can be found in the instructions for your computer and in its operating system LD Wake on USB with the IntegraMouse Plus only works via the connected USB cable not in wireless mode and only on the USB ports of the computer that are directly on the mainboard
28. n Through warming thermo disinfection the mouthpiece bends and therefore no longer fits optimally on the control unit Before you use the cleaned mouthpiece again please ensure that the mouthpiece is completely dry and has cooled to room temperature The mouse pointer moves independently on the screen Recalibrate Can I set the IntegraMouse Plus to environmental control The IntegraMouse Plus is a computer mouse and may only be connected with those environmental control systems that are designed for use with a computer mouse Unable to connect IM Connect and IntegraMouse Plus Check that the IntegraMouse Plus battery is charged sufficiently If necessary connect it to the power pack included Follow the instructions as described in Chapter 7 3 31 Wake on USB is not working although everything on the computer is set correctly Wake on USB only works in cable connected mode and only with USB ports that are located directly on the mainboard Connect the IntegraMouse Plus to a suitable USB port with the helo of a USB cable and change the USB connection if necessary 14 KEY TO THE SYMBOLS CE SN Applied part type B CE mark Conformity with Medical Device Directive 2007 47 EC Disposal in accordance with WEEE Directive 2002 96 EC HF transmission radio Warning Follow the instructions for use Information on use Serial number in the format Components M C Version Year 2 digits 4 digit continuous n
29. ng long periods of work it can be necessary to begin a manual calibration e g after readjusting the device or weight changes in the mouthpiece due to the collection of moisture or in strong changes in the light conditions sunlight To begin manual calibration you have the following options By quickly pressing the ON OFF button By the following sucking blowing combination Blow for 3 seconds suck for 3 seconds with max 1 second pause in between The calibration occurs automatically for the selected mode and is displayed by running LEDs on the IntegraMouse Plus Blow for 3 seconds Suck for 3 seconds Maximum pause between both actions 1 second fi Sucking blowing combination for calibration by the user 7 5 Using the IntegraMouse Plus silicon tube lf you prefer a softer surface on the mouthpiece push the silicon tube included over the mouthpiece opening up to the second groove see Figure 8 Carry out calibration after putting on the silicon tube Check regularly whether the silicon tube is still completely pressed on and correct the position if need be th ei Figure 8 Correct placing of the silicon tube Never use any other than the original silicon tube and always ensure that the silicon tube is sitting securely on the mouthpiece Only put the mouthpiece so far into your mouth that you cannot extend your lips and teeth over the silicon tube The silicon tube may only be used by persons that are not in danger of
30. nnnnnnnnnnnnnnnnnnn nennen 16 8 Application and functionality u 400440040ne nenn nnnnenenn nenn anne nene nenn nun nene nenn nnne nenn nenn nenn 17 8 1 Switching on the IntegraMouse Plus 0222200202002000 00000 none nenn nenn nenn nennen 17 8 2 Three operating modes Mouse Joystick CurSOl ccccccccsseeeseeeeaeeeeseeeseeeaees 17 8 3 IntegraMouse Plus energy SAVING MOE cccccceeeeceeeeceeeeseeeeneeeeseeeeseeeeseeeseneenees 21 8 4 Switching off the IntegraMouse PIUS cccccccsecessecesseeeseseeseeesaeeecaseesaeeeseeeesaes 21 8 5 MNakeon USB unsre 21 9 Hygiene maintenance and testing Surcsusisiisicieienieiiiiaileiilellelileilieii 22 9 1 Cleaning the mouthpiece and changing the MEMbrane cccccceeeeseeeeeeeeeeeeeeees 22 g2 Glednng the COV Esera E ate tee ee 25 93 MECGCIAIOING ING Daliery ss 26 9 4 MEIOLO9ICAL IEelINg enisete a ee 26 10 Permissible SVSICM tasesmiiscteiuasiromnnesnnianaema een 27 Tie SAMDIENECONGIIDN SEE E E 29 12 Waste ASOSAN A a a a AA 30 13 Frequently asked questions and ANSWEIS cccccccsseceesesensecenseeenseeenseeensesensesensesenees 30 14 Keyta INES VIM DOIS a 32 15 Pr d tand DEMOrMaNGe Qdla zus ea reale 33 16 Electromagnetic compatibility u u04040 Rene nnnnenene nenn nenne nenn nenn nenne nenn nenn nenne nenn nennen 35 Iv iDeclaratlon Cl COMOnMny ic iccse ce cessctotageesuinciesee E A 39 1
31. not yet required Off below 20 Low battery please charge Table 3 Battery power display Charging The charging of the battery occurs via the power pack included or by connection to the computer via the USB cable In both cases use the mini USB socket on the reverse of the IntegraMouse Plus Plugging in is only possible in one direction The charging process begins immediately after plugging in and takes 2 3 hours Progress is indicated on the battery display LED 1 LED 2 Battery power Note SSS Off Battery is Leave power pack plugged in until charging being charged process is completed green green Battery fully Power pack can be unplugged charged Table 4 Charging process display Only use the power pack or the USB cable supplied to charge or operate the mouse Even when you have another power pack with mini USB available e g from a mobile telephone do not use this to charge or operate the IntegraMouse Plus The power pack included is a special power pack for medical purposes N Never change the battery yourself If you suspect a problem with the battery contact the manufacturer or your dealer 9 4 Metrological testing Every medical product especially when being used in a clinical environment should regularly be checked for safety Regular safety testing at the most every 24 months can be carried out by the operator by authorised service personnel or by the manufacturer e g in Austria and Germany
32. onnect flashes 5 Switch on the IntegraMouse Plus by pressing the ON OFF button and keep this pressed down for about 3 seconds Warning The IntegraMouse must be switched off and must not be connected to the power pack After the running lights have come on once the blue LEDs on the IntegraMouse Plus begin to flash alternately 6 After successful connection the green LED on the IM Connect and the IntegraMouse Plus is ready for use IntegraMouse Plus in wireless mode with supply via the power pack 1 Insert the IM Connect into one of the computer s USB ports 2 Connect the IntegraMouse Plus to a plug using the power pack 3 The IntegraMouse Plus switches on automatically and the calibration process is shown through the running LEDs 4 After successful connection the green LED on the IM Connect and the IntegraMouse Plus is ready for use 7 4 Calibration Before use the IntegraMouse Plus must be calibrated in its relevant location As a rule this happens automatically directly after switching on and plugging in the IntegraMouse Plus Automatic calibration Automatic calibration always occurs after plugging in and switching on the IntegraMouse Plus O Do not move the IntegraMouse Plus during the calibration process and do not change its position or situation This could lead to incorrect calibration and therefore to malfunctioning of the IntegraMouse Plus and make recalibration necessary 15 Manual calibration Duri
33. oss the screen drag amp drop Ly The characteristics of the mouse pointer e g the speed can be set individually in the respective operating system The assignments of left and right clicks can also be changed there For more information see the help function of your operating system O If it is not possible for the user to activate the mouse clicks by sucking and blowing the clicks can be actioned through additional auto click software Your LIFEtool dealer would be glad to advise you about this In some cases other external sensors can also be used Your LIFEtool dealer would be happy to advise you about the choice of suitable sensors and switch interfaces 18 Joystick mode joystick configuration The joystick mode enables the operation of computer games which can be played using a Windows standard joystick with two buttons The movement of the mouthpiece effects the analogue deflection of the joystick Movements can be carried out dynamically from slowly small displacement to quickly larger displacement Sucking and blowing correspond to the joystick keys 1 and 2 Activated joystick mode is indicated by the lighting up of the corresponding blue LED O The basic calibration and further settings of the joystick can be carried out individually in the settings menu of the respective operating system For more information see the help function of your operating system Cursor mode keyboard function Cursor mod
34. owing function of the IntegraMouse Plus and also functions as a mechanical protective barrier to the electronics The membrane should regularly be checked for damage and replaced IntegraMouse Plus silicon tube lf you prefer a soft surface on the mouthpiece the silicon tube can be placed over the mouthpiece This can make it more comfortable to use Pay attention to the instructions for safe use of the silicon tube in Chapter 7 5 Using the IntegraMouse Plus silicon tube 10 IntegraMouse Plus mounting system The mounting system is used for flexible installation and securing of the IntegraMouse Plus in the working position desired The mounting system can be set up for example on the table or on the bed Not included in the scope of delivery Contact the manufacturer or your dealer for further information Figure 5 Mounting system N Ensure that the IntegraMouse Plus cannot be installed with the mounting system on moving systems e g on wheelchairs There is a danger of injury e g when driving over obstacles The following optional articles can be supplied on request as deliverable accessories LIFEtool article number Description LIFEtool IntegraMouse Plus mounting system The following optional articles can be obtained on request as spare parts LIFEtool article number Description 11220 LIFEtool SPARE PART IntegraMouse Plus Connect 11221 LIFEtool SPARE PART IntegraMouse Plus USB cable 11222 LIF
35. rough this hygiene and cleanliness are guaranteed also during use by several users for example in public institutions or during use in clinics and rehabilitations centres where the risk of an infection by more resistant germs is present 4 SAFETY INSTRUCTIONS As with every medical product there are a few things that must be noted in order to ensure the safe and smooth operation of the IntegraMouse Plus e Use this product only for the intended purpose according to these instructions for use Any other use is improper and therefore dangerous The manufacturer cannot be held responsible for damages which are caused by inappropriate or improper use Good head control and mouth motor skills are required for the operation of the IntegraMouse Plus Therefore the IntegraMouse Plus must not be used by persons who suffer from e g uncontrolled spasms Tourette s syndrome or epilepsy e Only connect the device to sources of power as described in the instructions for use Otherwise dangers may occur e Do not expose the device to extreme temperatures and avoid direct sunlight This can Cause damage especially to the built in battery Do not expose the device to any shaking Knocking dropping and protect it from dirt and damp However should the device be exposed to these conditions allow your contract partner to examine it in order to ensure that it is safe and usable e If you do not use the device for extended periods of time switch the devi
36. rwise you could destroy the device In the clinical sector multiple use of the device by several users is forbidden The re use of the mouthpiece the membrane or the silicon tube is also forbidden Use these three components as disposable products and change them regularly after use e g once a day The other components should be used in accordance with the cleaning and disinfection plan Disinfection by wiping In special environments e g hospitals it is necessary to carry out regular disinfection by wiping the device The IntegraMouse Plus can be disinfected with any surface disinfectant product that is intended for the disinfection of LEXAN polycarbonate and aluminium Under no circumstances may any components of the IntegraMouse Plus be subjected to steam or water sterilisation The following cleaning products can be used Mikrozid Sensitive liquid or Mikrozid Sensitive wipes from the company Schulke amp Mayr GmbH www schuelke com Carry out the disinfection by wiping according to the manufacturer s instructions and ensure that no moisture seeps into the IntegraMouse Plus 25 9 3 Recharging the battery Battery power display On the front of the IntegraMouse Plus there is a display consisting of two light emitting diodes LEDs in the form of a battery which displays the battery power and the charging progress LED 1 LED 2 Battery power Note DL gt 100 71 Battery fully charged 70 21 Battery OK charging
37. thpiece see figure 13 Figure 12 Placing the membrane Figure 13 Correct position of the membrane 11 Carefully place the mouthpiece on the IntegraMouse Plus again Pay attention to the direction in which you placed it on and move the mouthpiece in a straight movement without using force see figure 14 Figure 14 Placing the mouthpiece N Warning Danger of scalding oO Disposal of the mouthpiece is recommended after no more than 6 months In the clinical sector the mouthpiece should be treated as a disposable product t The interval between changes of the mouthpiece must be determined by a doctor or by specialist staff advisor hygiene representative Special safety precautions must especially be obeyed when there is suspicion of infectious diseases 24 The mouthpiece or other components of the IntegraMouse Plus are not intended for any kind of sterilisation not even e g for sterilisation with steam or gamma sterilisation 9 2 Cleaning the device Clean the device regularly about once a week The parts of the IntegraMouse Plus mouthpiece IM connect power pack including cable and stand can be cleaned at any time by wiping with a damp lint free cloth Never use sharp cleaning objects to clean the components as this could destroy the surface The IntegraMouse Plus and IM Connect contain sensitive electronics Never immerse these components in water and also never use running water to clean them othe
38. ty Therefore install and use the IntegraMouse Plus only for the purposes set out in these instructions for use The IntegraMouse Plus along with the specified accessories which are also delivered cf chapter 5 Scope of supply cf chapter 3 Product information and use as per regulations and also chapter 4 Safety instructions fulfils the limit values prescribed The use of other apparatus or linking with other devices is not planned and can therefore lead to increased emission of radiation or reduced interference immunity against electromagnetic fields Also consider that the radio waves of the IntegraMouse Plus and those of the IM Connect could influence other electrical devices N Always keep a working clearance of at least 10 cm between IntegraMouse Plus or IM Connect and other medical electrical devices Note also the guidelines in the following tables Guidance and manufacturer s declaration electromagnetic emissions The IntegraMouse Plus and its accessories are intended for use in the electromagnetic environment specified below The customer or the user of the IntegraMouse Plus and its accessories should assure that they are used in such an environment Compliance Electromagnetic environment guidance RF emissions me m a The IntegraMouse Plus and its accessories are Harmonic emissions suitable for use in all establishments including Class A domestic establishments and those directly IEC 61000 3 2 conne
39. uction max 5 IntegraMouse Plus systems with 5 IM Connect on 5 computers 5x25x11 mm 11g 33 Power pack Description Input voltage Output voltage Input current Output current Output connection Protection class Adaptor kits for Measurements Weight USB cable Description Colour Length Connections Mouthpiece Description Material Application part Measurement Weight Membrane Description Material Measurements Weight Silicon tube Description Material Hardness Diameter Length Authorisations Globe Tek Model GTM41076 605 230 VAC 50 Hz 5 VDC 0 5A 1 2A Mini USB 2 North America Japan Blade Q EU R European Blade Q UK R United Kingdom Blade Q SAA R Australian Blade 74 x 43 5 x 36mm without connector cap 125 g without connector cap Qualtec USB cable 3021009 06 Black 1 8m USB type standard A USB type mini A IntegraMouse Plus mouthpiece SABIC Lexan HP3NREU Type B A 65 x 25 x 28 mm 7Q IntegraMouse Plus Membrane Hard part SABIC PP PCG H10 Soft part TPE TM3MED Diameter 17mm height 6 mm lt 1g VERSILIC S60V34B Silicon Shore A 62 5 inner outer 6 10 mm 19 1 5 mm European Pharmacopoeia 83 1 9 FDA 21CFR 177 2600 34 16 ELECTROMAGNETIC COMPATIBILITY ar The IntegraMouse Plus is a medical electrical device and is therefore subject to special safety precautions with regard to electromagnetic compatibili
40. umber e g M1 0 11 0001 Manufacturer Direct current Protection class II double insulation Use by YYYY MM 32 15 PRODUCT AND PERFORMANCE DATA IntegraMouse Plus Voltage Current Radio Sensitivity Degree of protection Duration of operation with battery Measurements Weight Compatibility 5V 0 3 A 2 4 GHz ISM Band 1dBm 1 3 mW Mouthpiece deflection max 3 mm Dynamic response characteristic Movement from about 10 g displacement force IP20 about 12 hours at continuous use about 48 hours at average use about 140 hours in standby mode 110 x 60 x 33 mm 759 From USB 2 0 Plug amp Play for the operating systems Windows XP Windows Vista Windows 7 Linux Mac OS X IntegraMouse Plus battery Description Type Nominal voltage Max charging current Max discharge current Charging time Nominal capacity Fuse Measurements Weight EEMB LP552036 Lithium polymer 3 7 VDC 1C 300 mA 2C 600 mA First time at least 3 hours usually 2 to 2 5 hours 360 mAh PCM Element Over discharge and short circuit protection 150 x 37 x 5 8 mm 7 19Q IntegraMouse Plus Connect Description Voltage Current Compatibility Transmission Radio range Parallel operation Measurements Weight IM Connect 0 1A From USB 2 0 Plug amp Play for the operating systems Windows XP Windows Vista Windows 7 LINUX Mac OS 2 4 GHz ISM Band 1dBm 1 3 mW about 5 m without obstr
41. uring operation as described above Wireless mode is then automatically deactivated and the battery is charged IntegraMouse Plus in wireless mode with battery operation In order to use wireless mode IM Connect is required 1 Insert the IM Connect into one of the computer s USB ports 2 Switch the IntegraMouse Plus on by pressing the ON OFF button The calibration process starts and will be shown by the running LEDs 3 After successful connection the green LED on the IM Connect and the IntegraMouse Plus is ready for use Ensure that the battery of the IntegraMouse Plus is charged enough when in wireless mode More information on the charging display can be found in Chapter 9 3 Recharging the battery The IntegraMouse Plus and IM Connect must be coupled for use This linking up is carried out as standard before delivery and need not be carried out by the user When replacing the IM Connect or in case of problems with the wireless connection the linking procedure can be carried out manually as follows 14 Linking up IntegraMouse Plus and IM Connect 1 Disconnect the IntegraMouse Plus from the power pack or the USB cable 2 Switch off the IntegraMouse Plus see Chapter 8 4 3 Insert the IM Connect into one of the computer s USB ports 4 Press the Connect button on the top of the IM Connect with the help of a sharp object e g ballpoint pen paper clip The linking process starts The green LED on the IM C
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