MyndStep 800102 User Manual Download Page 35

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2. Accessories

2.1 Lead Wire

The side for connecting device output socket;

The side for connecting electrodes.

2.2 Self-adhesive Electrode

The part which contacts the patient is the backside of the electrode, and the material is a conductive

hydrogel. When using, place the electrodes on the patient's skin, and connect the snap button of the
electrode to the electrode lead hose. Before applying electrodes to the patient skin, you should use
alcohol or soapy water to clean the skin first.

Summary of Contents for 800102

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Page 3: ...linical Instructions 5 Safety Instructions 8 EMC Guidance 21 Inspection of the Goods 29 Overview of the Unit 31 MyndStep Application 36 Operation Guidance 61 Care and Maintenance 69 Troubleshooting 73 Technical Specifications 76 Assistance 80 Warranty 81 ...

Page 4: ... become familiar with the controls as well as the accessories before operating the unit Specifications put forward in this manual were effective at the time of publication However owing to the continually improving policy of MyndTec Inc any changes to these specifications may be made at any time without obligation on the part of MyndTec Inc Before administering any treatment to a patient the user ...

Page 5: ...pinal Cord Injury SCI Traumatic Brain Injury TBI Multiple Sclerosis MS Cerebral Palsy CP The MyndStep system uses an accelerometer and an inclinometer to signal stimulation of the common peroneal nerve which stimulates the anterior tibialis muscle The motor output ankle dorsiflexion will lift the foot to clear the ground s surface during ambulation and manage a step curb doorsill and stairs Workin...

Page 6: ...4 AC Input Processor PWM Intensity Adjustment Pulse Generating Electrode Current Feedback Communication of Mobile Phone APP and Bluetooth Bluetooth Chip Battery Power Adapter Button ...

Page 7: ... phase of gait and appropriate electrical stimulation of the leg and ankle muscles may improve gait by flexing the foot of persons who have lost or impaired function Contraindications 1 Do not use it on persons with implanted demand type cardiac pacemakers or defibrillators 2 Do not use it on persons with severe heart failure or arrhythmia 3 Do not use on persons with histories of seizure disorder...

Page 8: ...ment area with bleeding tendency metal matter or tuberculous lesions 9 Do not place the electrodes over areas in which symptoms of existing thrombosis or thrombophlebitis are present 10 Do not place the electrodes over areas with acute suppurative inflammation symptoms 11 Do not place the electrodes over areas of skin allergy infection rash wound or scars 12 Do not place the electrodes over malign...

Page 9: ...e and consult your doctor if you experience adverse reactions to the device Possible adverse reactions may include the following skin irritation beneath the electrodes burns beneath the electrodes headaches or other painful sensations ...

Page 10: ...ructions Symbols 1 Medical Device Symbols Symbols Explanation Manufacturer Date of Manufacture Proper waste disposal for electrical and electronic equipment WEEE See disposal for instructions Type BF Applied Part s ...

Page 11: ... Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he she practices to use or order the use of the device This device emits non ionizing radiation This symbol indicates that this device is a Class II equipment according to IEC 60601 1 when charging Refer to the instruction manual booklet ON OFF Button ...

Page 12: ...ge Symbols Symbols Explanation This Way Up Fragile handle with care Keep Dry Temperature Limitation between 20 C and 55 C Humidity Limitation less than 93 Atmospheric Pressure Limitation between 86kPa and 106kPa ...

Page 13: ...ting this equipment The definitions of these symbols are as follows Text with a CAUTION indicator will explain possible safety infractions that could potentially cause minor to moderate injury or damage to equipment Text with a WARNING indicator will explain possible safety infractions that will potentially cause serious injury and equipment damage Refer to the Instruction Manual Booklet ...

Page 14: ...lying with IEC 60601 1 Warnings and Cautions Please carefully read and understand the following warnings and cautions to ensure the safe and correct use of MyndStep and prevent injury Read understand and practice the precautionary operating instructions Know the limitations and hazards associated with using MyndStep Observe the precautionary and operational decals placed on the unit ...

Page 15: ...he flammable anesthetic gas and oxygen or nitrous oxide In case of device failure or other obvious defects switch the unit off immediately and notify a certified service technician Adjustments or replacement of components may result in the equipment failing to meet the requirements for interference suppression The long term effects of electrical stimulation are unknown Do not apply stimulation ove...

Page 16: ... patient is in the bath or shower Do not apply stimulation while the patient is driving operating machinery or during any activity in which electrical stimulation can put the patient at risk of injury Do not use this device if you have a cardiac pacemaker implanted defibrillator or other implanted metallic or electronic device Such use could cause electric shock burns electrical interference or de...

Page 17: ...f necessary please contact the company or the company authorized maintenance personnel to replace them Please dispose of the equipment and other accessories according to local regulations Do not treat them as household waste Do not put the device in fire or water If the batteries are not properly disposed of it may cause a battery explosion Do not use the unit when it is charging Always check the ...

Page 18: ...ation is applied over the uterus when menstruating Use caution if stimulation is applied over areas of skin that lack normal sensation Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner Keep this device out of the reach of children Do not use this unit while sleeping The main unit may develop trouble or the pad may move to an unexpected reg...

Page 19: ...or hypersensitivity due to the electrical stimulation or electrically conductive medium gel Always disconnect the power charger from the mains after use Please charge the unit at least every three months during long term storage Federal law restricts this device to sale by a practitioner licensed by the law of the State Due to a mobile phone system upgrade or cyber security upgrade we will update ...

Page 20: ...d used under the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the ...

Page 21: ...mful interference and 2 this device must accept any interference received including interference that may cause undesired operation This device complies with FCC radiation exposure limits set forth for an uncontrolled environment This transmitter must not be co located or operating with any other antenna or transmitter FCC ID 2ANHPLGT 233 ...

Page 22: ...r license Communication between the main unit and the MyndStep Application on the smart phone is via Bluetooth Bluetooth Specifications Bluetooth Version 4 0 Frequency Range 2 402 GHz 2 4835 GHz Modulation Type GFSK Effective Radiated Power 0 dBm Quality of Service QoS Throughput 6 4Kb s Latency 500ms Packet Error Rate 10 ...

Page 23: ...place MyndStep adjacent to or stacked with other equipment or it could result in improper operation If such use is necessary all the devices should be observed to verify that they are operating normally Portable RF communications equipment including peripherals such as antenna cables and external antennas other than the smart phone to be used with MyndStep should be used no closer than 30 cm 12 in...

Page 24: ...sult in improper operation Accessory Information Item Cable Length Manufacturer Part Number Power cord with adapter 1 0 m Shenzhen Longxc Power Supply Co LTD 3 f B building Wentao Industrial Park Yingrenshi Yongxin Road Shiyan street Bao an District 518108 Shenzhen Guangdong PEOPLE S REPUBLIC OF CHINA Electrode lead wire 0 3 m MyndTec 800111 ...

Page 25: ...Group 1 MyndStep uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission CISPR 11 Class B MyndStep is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used fo...

Page 26: ...terial the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 0 5kV 1 kV line s to lines 0 5kV 1 kV 2 kV line s to earth 0 5kV 1 kV line s to lines Mains power quality should be t...

Page 27: ...eration during power mains interruptions it is recommended that MyndStep be powered from an uninterruptible power supply or a battery Power frequency 50 60Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the t...

Page 28: ...ance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz 80 MHz 6 V rms in ISM bands and amateur radio bands between 150 kHz and 80 MHz 80 AM at 1 kHz 3 Vrms 150 kHz 80 MHz 6 V rms in ISM bands and amateur radio bands between 150 kHz and 80 MHz 80 AM at 1 kHz N A Radiated RF IEC 61000 4 3 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz N A Proximity fields from RF wireless communic...

Page 29: ...m power W Distance m Immunity TEST LEVEL V m 385 380 to 390 TETRA 400 Pulse Modulation b 18Hz 1 8 0 3 27 450 430 to 470 GMRS 460 FRS 460 FM c 5 Hz deviation 1 kHz sine 2 0 3 28 710 745 780 704 to 787 LTE Band 13 17 Pulse Modulation b 217 Hz 0 2 0 3 9 810 870 930 800 to 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse Modulation b 18 Hz 2 0 3 28 ...

Page 30: ...ation b 217 Hz 2 0 3 28 5240 5500 5785 5100 to 5800 WLAN 802 11 a n Pulse Modulation b 217 Hz 0 2 0 3 9 NOTE a For some services only the uplink frequencies are included b The carrier shall be modulated using a 50 duty cycle square wave signal c As an alternative to FM modulation 50 pulse modulation at 18 Hz may be used because while it does not represent actual modulation it would be the worst ca...

Page 31: ...that the arrows are pointing upward Remove the transport packaging upward Remove the remaining foam material 2 Inspections Immediately upon unpacking the unit perform the following steps 1 Verify the delivery documents to ensure that the delivery is complete 2 Check the external components and accessories for possible damage due to transport 3 Verify that the packaging contains the following ...

Page 32: ...d Wire 800113 1 piece 4 MyndStep Self Adhesive Electrode with Magnetic Connection 800111 4 pieces 5 MyndStep Foot Drop Brace 800112 1 piece 6 MyndStep User Manual 800115 1 piece Other parts of MyndStep are available as accessories on demand Visit the website www myndtec com or call us at 1 888 363 058 to obtain more information ...

Page 33: ...g intensity button 4 ON OFF button 2 Decreasing intensity button 5 Output socket connect electrode lead hose 3 Indicator light see table meaning of indicator light 6 Micro USB port connect power adapter Slide the slider to output sockets when charging ...

Page 34: ...cy Stimulation on may be 10mA r m s or 10V r m s Yellow 1 Slight light Low battery cannot be used White Flash at 3Hz frequency for 1s and then turn off the unit Charging Blue Flash at 1Hz frequency Fully charged Blue Always bright Electrodes fall off during treatment White Flash at 1Hz frequency NOTE The device can deliver an output of more than 10mA r m s or 10V r m s when the output intensity is...

Page 35: ...The part which contacts the patient is the backside of the electrode and the material is a conductive hydrogel When using place the electrodes on the patient s skin and connect the snap button of the electrode to the electrode lead hose Before applying electrodes to the patient skin you should use alcohol or soapy water to clean the skin first ...

Page 36: ...34 No Model Picture Size Connector Remark 1 800111 50mm 50mm square Snap Ф 3 0 mm Standard ...

Page 37: ...35 2 3 Foot Drop Brace ...

Page 38: ... 4 3 or later mobile phone with 4 0 Bluetooth IOS 8 0 or later iPhone mobile phone with 4 0 Bluetooth 1 Download and Install You can download the MyndStep Application from the APP stores Download the Android version from Google Play and the IOS version from Apple App Store Click the MyndStep Application installation package on your phone and follow the prompts to install the application ...

Page 39: ...will search the devices automatically as shown below When it searches the interface will display the device found Click the device that has searched to connect the device until it becomes Connected which means the device has connected The Bluetooth address of the unit is below the product model You can paste this Bluetooth address on the unit to distinguish another unit ...

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Page 41: ...ation such as battery percentage hardware and software version of the device Also you can click Identified Color to select a color to distinguish other units Select a color and confirm then paste the same color label on the unit surface ...

Page 42: ... Mode Train mode is suitable for muscle training for patients who need active training to help sit or lie down It promotes muscle recovery prevents muscle atrophy improves joint range of motion and increases local blood circulation Walk mode assists patients in walking with electrical stimulation It helps patients restore their gait and provide the correct way of walking In addition it helps patie...

Page 43: ...k Train Mode at the main interface to enter this interface as shown on the left The current regulation module displays the connection status The gray circle indicates that the device did not connect Once it connects it will become blue as the following picture shows ...

Page 44: ...of the pulse Set frequency pulse width pulse duration and treatment time Take frequency setting as an example Click the frequency bar and pop up the frequency setting window as shown on the left Swipe up or down to select the desired frequency value range from 1 Hz to 80 Hz and then click the OK button The frequency bar displays the selected frequency value ...

Page 45: ...se Train Modulation Interface as shown on the left picture Set each parameter under Pulse Train Modulation The setting method is the same as the frequency setting After all the settings are complete click the OK button and the page jumps to the training mode interface ...

Page 46: ... 0 0 5 Hold time s 1 0 30 0 3 0 1 0 Ramp down time s 0 5 5 0 1 0 0 5 Interval time s 2 0 60 0 10 0 1 0 Treatment time min 1 60 10 1 Output intensity mA 2 0 100 0 1 1 Pulse Train Modulation is a type of amplitude modulation program The Interface is as shown on the left details in the Parameter Description of Pulse Train Modulation 2 The output intensity can only be adjusted after starting ...

Page 47: ...he intensity is maintained at the set level is the time when the electrical stimulation is activated Ramp down time tf the time of the intensity gradually decreases from the set level to 0 in order to avoid a sudden decrease in intensity and to make the treatment feel more comfortable Interval time ti the duration of no intensity output The interval time avoids muscle fatigue caused by long term m...

Page 48: ...le will turn blue 4 Adjust output intensity Output intensity expressed in mA defines the amplitude of the pulse After clicking the start button the output intensity can be adjusted Swipe left or right on the Current regulation circle to select the output intensity Click the button to view the interface pop up tip ...

Page 49: ...e left If you want to change the mode press and hold the stop button to stop the current treatment 6 End of the treatment At the end of the treatment the unit stops output The indicator is switched from yellow to green and flashes at 1Hz frequency and the mobile application interface shows the treatment is finished Press the OK button to return to the pre start state ...

Page 50: ...ts which had connected The gray circle indicates that the device did not connect Once it connects it will become blue 2 Electrode Placement Tips Click at this interface to view the pop up prompt box You can place the electrodes according to this guidance 3 Select right or left leg Select the left or right leg according to the actual situation This will affect the measurement of the angle ...

Page 51: ...ity is adjustable only after starting 5 Treatment Setup After setting the output frequency and pulse duration click Setup Adjust the output current and frequency according to your muscle contraction Note The therapist or patient must ensure the leg side being treated matches with the left or right leg selection on the screen This will enable the selection of the right current intensity to suit the...

Page 52: ...r After setup click next step to jump to the interface of Sensor calibration At this stage there is no electrical stimulation output Stand upright according to the figure on the APP and click on Calibrate to calibrate the sensor ...

Page 53: ...ompleted it will automatically enter the walking mode treatment interface The following parameters are displayed in real time after startup ITEM Description Displays the step numbers you have walking Displays the distance you have walked Displays the time you have spent walking ...

Page 54: ... device can trigger electrical stimulation when the patient s knee angle rises to 30 and it can trigger electrical stimulation When the patient s knee angle drops to 5 the device s electrical stimulation output is turned off The duration of electrical stimulation is 1s 3s ...

Page 55: ...53 8 Start treatment Click the start button to start the treatment The output current is the value of the previous intensity setting The intensity can be adjusted again at this step if needed ...

Page 56: ...erface and appear as shown on the left If you want to change the mode press and hold the stop button to stop the current treatment 10 End of the treatment Press and hold the stop button to stop the treatment The unit stops output and returns to the pre start state The indicator is switched from yellow to green and flashes at 1 Hz frequency ...

Page 57: ...evice will flash white at 1 Hz the treatment time stops counting down and the APP displays a pop up tip At the same time the device stops output i e the output intensity is reduced to 0 mA In this case check the connection of the electrodes and press the OK button and then restart the treatment ...

Page 58: ...ck the train mode at the main interface to enter the interface and set the frequency pulse duration treatment time and pulse train modulation parameters Click Favorites in the upper right corner then pop up the page as shown on the left set the name of the custom protocol and click the OK button ...

Page 59: ...er the custom protocol Choose one custom protocol you want and click to enter the detail page which shows the treatment parameters of the custom protocol Click Enter Treatment to enter the treatment For details please refer to clause 3 1 Train Mode Interface of this chapter 3 Delete custom protocol Swipe the custom protocol to the left and click Delete in the custom protocol interface ...

Page 60: ...58 6 Help Center Click the icon in the upper left corner of the main interface or press more at the bottom of the main interface to see more click the icon and enter the help center interface ...

Page 61: ...59 6 1 Using guidance There is some introduction on how to operate MyndStep to help you understand the use of the device ...

Page 62: ...60 6 2 FAQ MyndStep Application includes a variety of common problems and you can learn more about MyndStep and treatment ...

Page 63: ...ator on the unit flashes blue during charging The status indicator stops flashing when the battery is fully charged NOTE If the rechargeable battery of the units is not fully charged when you start treatment the batteries may run out during the treatment We advise you always fully charge the unit before you start treatment NOTE Always disconnect the power charger from the mains after use Do not us...

Page 64: ... units can be connected simultaneously and two units can perform electrical stimulation simultaneously 2 Starting a Treatment Train Mode 1 Clean the skin and pace the electrodes Use alcohol or soapy water to clean the skin and remove the grease After the skin dries place one electrode on the Common peroneal nerve and the other one at the point of tibialis anterior of the leg located outside of the...

Page 65: ...ect Train Mode and set parameters Click Train Mode at the main interface to enter the Train Mode interface set parameters such as frequency pulse duration and treatment time according to the actual situation see Clause 3 1 in chapter MyndStep Application 4 Start Treatment Click the start button and the treatment begins ...

Page 66: ... or through the buttons on the unit The output intensity should be increased slowly from small values to avoid excessive stimulation Because your body initially adapts to the intensity of the stimulation you may have to adjust the intensity level after some time to ensure optimal stimulation ...

Page 67: ...kin dries place electrodes according to the schematic of the MyndStep APP Place one electrode on the Common peroneal nerve and the other one at the point of tibialis anterior of the leg Located on the outside of the calf 2 Connect the unit Connect one end of the electrode lead hose to the electrodes and the other end to the unit ...

Page 68: ...he main interface to enter the interface click Treatment Setup and adjust output intensity 4 Fix Leg Brace After finishing setup fix the strap on the calf according to the schematic of the MyndStep APP and place the unit into the pocket of the Leg Brace ...

Page 69: ...ly transferred to the treatment interface Click the start button and then you can start your walking training 7 Adjust output intensity You can adjust the output intensity in the MyndStep interface or through the button on the unit The output intensity should be increased slowly from small values to avoid excessive stimulation Because your body initially adapts to the intensity of the ...

Page 70: ...ed In Walk Mode you need to stop the treatment manually Please press and hold the stop button to stop the treatment The unit stops output The indicator is switched from yellow to green and flashes at 1 Hz frequency Remove the electrodes electrode lead wire and leg brace from your body Stick the electrodes back to the plastic film place them in the storage box along with the main unit electrode lea...

Page 71: ...e surface of the main unit 3 Clean the Leg Brace Wipe the surface with a damp cloth or antiseptic wipe after use It can be washed if necessary moderate amount of neutral detergent soak for a short time be careful gently rinse and dry naturally Not machine washable do not use bleach Do not clean the main unit with an organic solvent such as gasoline or diluents otherwise it could be deformed and th...

Page 72: ...Check the power line to ensure no distortion fracture etc These circumstances may cause a fire hazard Please replace a new power line immediately 2 Replace the electrodes if they are damaged or torn they are past the use by date they have lost their adhesiveness Never use plaster or tape to attach them to your skin stimulation feels weaker when the stimulation is uncomfortable i e you experience a...

Page 73: ...ized 3 Disposal According to EC Directive WEEE Waste Electrical and Electronic Equipment the equipment must not be disposed of as unsorted municipal waste and must be collected separately Dispose of this product according to local regulations Contact your local authorities for information regarding the disposal of the unit and accessories ...

Page 74: ... be harmful to humans or the environment Never dispose of these batteries with household waste Please take them to an official collection point or a service center to remove the rechargeable battery and follow the local rules for a separate collection of the batteries ...

Page 75: ... mobile phone could not connect with the unit 1 The unit is not turned on 2 Mobile phone Bluetooth is not open or mobile phone Bluetooth problems 3 the distance between the mobile phone and the unit is too far 4 The unit has connected to another mobile 5 The unit is asleep and Bluetooth is stopped 6 Other reasons 1 Turn on the unit 2 Please turn on the Bluetooth on the mobile phone or change to an...

Page 76: ... The electrode lead wire has been damaged 1 Press the start button 2 Adjust the output intensity 3 Re connect the electrode lead wire 4 Replace a new electrode lead wire 5 Stimulation is uncomfortable 1 The output intensity is too high 2 Electrodes are too close together 3 Damaged or worn electrodes or electrode lead wires 4 Electrode active area size is too small 1 Decrease the output intensity 2...

Page 77: ...lead wire is poorly connected 2 The electrodes are in poor contact with the skin 3 Electrodes do not stick well 1 Re connect the electrode lead wire 2 Re connect the electrodes and lead wires 3 Replace electrodes Apply electrodes to a clean dry surface 7 The unit has output but treatment without sensation The output intensity is too low Increase the output intensity ...

Page 78: ... Treatment Mode Train Mode and Walk Mode Pulse Duration Adjustable 50 500μs increments of 10μs Pulse Frequency Adjustable 10 80Hz increments of 1Hz Pulse Train Modulation for Train Mode only Parameter Range Stepping Ramp up time s 0 5 5 0 0 5 Hold time s 1 0 30 0 1 0 Ramp down time s 0 5 5 0 0 5 Interval time s 2 0 60 0 1 0 ...

Page 79: ...stimulation output is turned off And the duration of electrical stimulation is 1s 3s Timer a Treatment time 1 60min increments of 1min b Timer tolerance 2 c When finished the device can stop output and prompt Output Intensity Adjustable 0 100mA increments of 1mA at 500Ω load Maximum Output Amplitudes V 55 V at 500 Ω Load Maximum Current r m s 50mA r m s at 500 Ω Load 2 Other Specifications Product...

Page 80: ...pected Life The expected useful life of the main unit is 4 years under normal usage 10 min per treatment 6 treatments per day The expected useful life of the electrode lead wire and leg brace is 12 months under normal usage 10 min per treatment 6 treatments per day Self adhesive electrodes Shelf life 24 months Useful life The electrodes may be used up to 15 times These numbers vary depending on th...

Page 81: ... Atmosphere Pressure 86 0 to 106 0kPa Environmental conditions of transport and storage Temperature 20 to 55 C Rel humidity 93 Atmosphere Pressure 86 0 to 106 0kPa Environmental conditions of transport and storage between uses Temperature 25 to 70 C Rel humidity 90 Atmosphere Pressure 86 0 to 106 0kPa NOTE Except for Self adhesive electrodes Works with Requires a smart phone with Bluetooth 4 0 And...

Page 82: ...rmed by the manufacturer For any assistance intervention and original spare parts please contact the manufacturer at the following address MYNDTEC INC 1900 Minnesota Court Suite 122 Mississauga ON L5N 3C9 Info myndtec com Tel 1 888 363 0581 Fax 1 877 796 4624 ...

Page 83: ...harge The warranty does not extend to wear parts To validate the warranty please complete the Warranty Card and send it with the copy of the original invoice to the email address info myndtec com within 7 working days of purchase 2 Warranty for the accessories power adapter leg brace and lithium battery The warranty period of the accessories power adapter leg brace and lithium battery is 12 months...

Page 84: ...he manufacturer the authorized dealer or a certified company service technician Defects or damage caused by labor furnished by someone other than the manufacturer the authorized dealer or a certified company service technician Any malfunction or failure in the product caused by product misuse including but not limited to the failure to provide reasonable and necessary maintenance or any use that i...

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Page 88: ...MyndTec Inc 800116 Rev 1 0 ...

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