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Neurotech avivastim xp, Instructions For Use Manual

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Summary of Contents for avivastim xp

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Page 3: ...sign products that help accelerate recovery and return patients to a more active lifestyle If you have further questions regarding AvivaStim XP please contact your prescribing physician or distributor that provided you with AvivaStim XP or neurotech at the address phone number below Yours sincerely The neurotech Team If you have questions or require further information please contact neurotech A D...

Page 4: ... full responsibility for any actions arising out of the use or misuse of this equipment Any modifications repairs or servicing must be undertaken by authorised Bio Medical Research Ltd personnel This manual is intended for the guidance of the clinician who should also decide the location of the electrodes The AvivaStim XP unit is produced by Bio Medical Research Ltd Parkmore Business Park West Gal...

Page 5: ...MODE 1 SAFETY INFORMATION TENS MODE 4 DESCRIPTION OF APPARATUS CONTROLS 7 DESCRIPTION OF APPARATUS DISPLAY 9 STEP BY STEP TREATMENT GUIDE 11 SYSTEM MAINTENANCE 15 TROUBLESHOOTING 17 TECHNICAL INFORMATION 18 PROGRAM INFORMATION 21 WARRANTY 22 ...

Page 6: ...ation and strengthening of atrophied muscle Please see page 21 Programs 1 8 for details Indications Neuromuscular Electrical Stimulation for relaxation of muscle spasms prevention or retardation of disuse atrophy increasing local blood circulation muscle re education immediate post surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion Contr...

Page 7: ...ing process c Over the menstruating or pregnant uterus and d Over areas of the skin which lack normal sensation Avoid placing the electrodes directly over metal implants if there is not at least 1 cm of muscle fiber in between However placement on the nearest muscle is possible If in doubt seek medical advice Precautions should also be taken if muscle stimulation occurs during heavy menstruation o...

Page 8: ...s a protective mechanism This device can deliver current densities in excess of 2mA cm2 when used at a high intensity with small electrodes See Technical Data for more details If any irritations skin reactions over sensitivity or other side effects occur please contact Bio Medical Research Ltd In such cases stop use immediately Irritations can usually be reduced by changing the position of the ele...

Page 9: ...Stimulation TENS program for the treatment of acute pain Please see page 21 Program 9 for details Indications Transcutaneous Electrical Nerve Stimulation TENS for an adjunctive treatment in the management of post surgical and post traumatic acute pain problems Contraindications Patients with electronic implants e g cardiac pacemaker or defibrillator as your neurotech product may interfere with the...

Page 10: ...ment on the nearest muscle is possible If in doubt seek medical advice Precautions should also be taken if muscle stimulation occurs during heavy menstruation or in the same month as the insertion of an IUP inter uterine pessary e g coil The same applies to the period 6 weeks after giving birth We recommend that stimulation is only applied around the abdominal or lower abdominal region following m...

Page 11: ...io Medical Research Ltd In such cases stop use immediately Irritations can usually be reduced by changing the position of the electrodes Note however that a slight reddening of the skin is quite normal under the electrodes during and for a short time after treatment Do not use the AvivaStim XP unit with the electrodes positioned on injection sites of medications drugs such as hor mone treatment si...

Page 12: ...used to pause the treatment session You must press and hold the button for 2 seconds to switch the unit off at the end of a treatment 2 Amplitude Controls Channels 1 and 2 Each intensity control controls one channel on the same side of the unit Pressing the upper key during treatment increases the intensity level by a factor of one for that channel Similarly pressing the lower key can decrease the...

Page 13: ...zero This function is available only at the start of a treatment session 5 Trigger Key Trigger mode When the key is pressed Trigger mode is enabled and the unit enters a contraction cycle for as long as the key is pressed When the key is released the unit enters the relaxation cycle To return to the programmed contraction relaxation cycle press any of the intensity keys The stimulation builds over...

Page 14: ...or check the battery follow the instructions provided on page 15 Connecting Leads Two sockets are positioned at the base of the unit for the insertion of the leads Fig 2 The leads are connected to the electrodes via moulded pins The electrodes and leads are removable and can be replaced if necessary Each lead is a separate channel one of which is light blue and the other dark blue Two plastic moul...

Page 15: ...contraction relaxation cycle on each channel 4 Displays the length of time left elapsed in the current session in hours minutes and seconds For a set treatment time program the timer will count down in minutes and seconds For an open treatment time it will count up from zero in minutes and hours 5 Battery status indicator indicates battery power remaining 6 Clock symbol appears when the Total Trea...

Page 16: ...it attach each lead to an electrode Fig 5 5 The AvivaStim XP is supplied with a set of electrodes The electrodes should be handled as stated in the manual Please note the following points A clinician must provide instruction on electrode placement and determine electrode sizes to be used The safety information provided in this manual must be followed The lead pins must be fully inserted into the e...

Page 17: ...ly for a period of 3 seconds The Total Treatment Time will reset to zero Display 4 The maximum Total Treatment Time is 99 hours and 59 minutes It will reset back to 00 00 when the maximum treatment time is reached 10 Slowly begin to increase the intensity on the channel you wish to use by pressing the corresponding intensity control As the intensity is being increased for a particular channel the ...

Page 18: ...nterrupt the treatment session e g to replace the electrodes briefly press the on off pause button The unit issues a beep and the pause icon appears on the display in order to signal the pause to the program Display 9 To deactivate the pause function press the on off pause button again Then the treatment session is restarted from where it was paused and the pause icon disappears from the display 1...

Page 19: ...deactivated When proper contact is restored stimulation builds over a 2 second period to the previously set intensity level 17 When the treatment is complete the stimulation will stop automatically You will hear a 10 second beep alerting you that the treatment session is complete and the display screen will appear as in Display 12 At this stage the unit should be switched off and all electrodes re...

Page 20: ...n the rear of the AvivaStim XP unit In order to open the battery compartment turn the AvivaStim XP onto the front Insert your thumb into the symbol shown on the battery compartment to unlock it and press it forwards This unlocks the battery compartment Now unfold the cover completely A directional arrow Fig 7 on the battery cover indicates the direction in which the cover opens To remove a battery...

Page 21: ...d Using other electrodes and leads may degrade performance levels Do not dispose of used electrodes and batteries in household rubbish or in an open flame dispose of them in accordance with regulations in your country Electrodes wear out over time If they are dirty or no longer adhere properly they need to be replaced Replace the leads if the sheathing is damaged and exposes the copper wire Repair...

Page 22: ...ioned Lead not fully inserted Broken lead The battery is low Faulty lead Check your skin for lotions pig ment marks dry marks or other factors that could increase resistance Faulty lead assembly Electrode faulty Poor skin electrode contact Solution Replace battery Remove battery replace correctly Remove plug re insert Replace electrode lead assembly Replace the battery Replace lead Slowly move ele...

Page 23: ...ss Park West Galway Ireland A number of symbols are provided on your unit Those not already explained are described below Power Requirements 9 Volt DC Battery Type 6F22 Inside the battery compartment indicates positive polar ity and indicates negative polarity DC Direct Current is indicated by the symbol Physical Specifications Unit Dimensions 105 x 68 x 28mm Weight Unit 3 35 oz Unit with battery ...

Page 24: ... This symbol means Type BF equipment SN stands for serial number On the rear of each XP model is the unit s individual serial number The letter preceding the serial number indi cates the year of manufacture where K denotes 2005 L denotes 2006 etc This icon on your XP model shows that the device meets the 93 42 EEC Directive for medical devices 0366 is the number of the notified body VDE 0366 Nomin...

Page 25: ...your local authorities if you need more information about collection points in your area Waste Electrical and Electronic Equipment can have potentially harmful effects on the environment Incorrect disposal can cause harmful toxins to build up in the air water and soil and can be harmful to human health ACCESSORIES Electrodes Valutrode Lite Valutrode by Axelgaard Manufacturing Company Inc Sizes 45m...

Page 26: ...Trigger None None Trigger Burst or Trigger Trigger PROGRAM INFORMATION 21 PROGRAM INFORMATION Continuous stimulation Ramp Down sec 1 1 1 5 1 0 5 0 5 0 5 0 5 Ramp Up sec 1 1 1 5 1 1 1 1 1 Relaxation sec Contraction sec Ramp Down sec Ramp Up sec NMES Programs TENS Program Note 1 For this program the output signal sequence is as follows Channel 1 enters a contraction cycle at frequency of 50Hz for 5 ...

Page 27: ...y of the intensity keys The stimulation builds over a 2 second period to the previously set intensity level WARNING The selection and setting of the program should only be made by the treating clinician WARRANTY Should your unit develop a fault within two years of purchase neurotech will undertake to replace or repair the unit and parts found to be defective with no charge for labor or materials p...

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Page 32: ...Part No XXXX XXXX Rev 1A Issued 12 09 ...

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