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SHOULDER PACEMAKER

TM

- User Manual 04-06EN

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Содержание SHOULDER PACEMAKER SPM Series

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Страница 2: ...SHOULDER PACEMAKERTM User Manual 04 06EN 2 ...

Страница 3: ... SUPPLIED 8 TECHNICAL FEATURES 10 INSTRUCTIONS FOR USE 13 FUNCTIONING OF THE DEVICE 15 DEVICE DESCRIPTION 15 BASIC INSTRUCTIONS 15 BEGINNING OF A STIMULATION SESSION 15 CHOICE OF THE PROGRAM 15 PROGRAM SELECTION 15 START OF STIMULATION 15 STOP AND SWITCH OFF THE STIMULATOR 15 BATTERY CHARGE STATUS AND STIMULATOR CHARGING PROCEDURE 15 ALARMS 16 PROGRAMS 16 MANUAL MODE 16 AUTOMATIC MODE 16 TRAINING ...

Страница 4: ...ore using the device Shoulder Pacemaker TM This manual is an informative document and not an independent training text for the use of the product For proper training please contact our support and assistance team at the following address info shoulderpacemaker com Technical assistance is provided by our team Any problem encountered must be reported to the address provided above Our team will provi...

Страница 5: ...ove function 6 7 8 It should be emphasized that not all shoulder disorders can be treated by muscle electrostimulation the competent doctor is responsible for selecting the correct indication and treatment based on the extent of the injury and the patient s medical history Conventional electrical muscle stimulation imposes a pre defined rhythm on the users patients as they need to adapt the speed ...

Страница 6: ...nesia The user must receive adequate training before using the device for the first time A maximum of 30 minutes of device use is required to complete a stimulation session based on Shoulder Pacemaker TM technology PERSON DESIGNATED AS THE SUBJECT OF THE TREATMENT The person designated to be rehabilitated with the Shoulder Pacemaker TM device is a person who can express himself understand and exec...

Страница 7: ...imulator Do not use the Shoulder Pacemaker TM device in areas where unprotected equipment is present for the emission of electromagnetic radiation Portable communication devices can interfere with electro medical devices In case of doubt about the use of the stimulator near another medical device contact the manufacturer of the device in question or the doctor The recommended operating temperature...

Страница 8: ...with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However th...

Страница 9: ...nd MySPM Home applications must be installed on a mobile phone tablet compatible with BLE communication and that runs on the Android operating system version 6 0 onwards and with at least 100MB of free disk space to allow installation and saving files The SPM01K3 kit configuration contains 1 electrostimulator REF SPM01 MySPM application REF SPM01A1 Medical device according to Directive 93 24 EEC a...

Страница 10: ...d from each other Shape of the pulses compensated biphasic wave in order to exclude any component of direct current and avoid residual polarizations on the skin Maximum pulse intensity instantaneous value 300 mA Maximum intensity of the pulses intended as an effective value mediated on 1s 10 mA Duration of a pulse 10 to 200 μs Maximum amount of electricity for one pulse 10 2 microcoulombs Pulse fr...

Страница 11: ...IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable Table 1 electromagnetic emissions Guidance and manufacturer s declaration electromagnetic immunity Shoulder Pacemaker TM is designed to operate in the electromagnetic environment specified below The customer or user of the device should ensure that it is used in such an environment Proof of Immunity Te...

Страница 12: ...the transmitter frequency Proof of Immunity Test level of IEC 60601 Level of compliance Recommended separation distance d RF Irradiate IEC 61000 4 3 10 V m da 80 MHz a 2 7 GHz 10 V m d 30 cm Proximity field immunity from IEC 61000 4 3 RF wireless communication devices TETRA 400 380 390 MHz 27 V m 27 V m d 30 cm GMRS 460 FRS 460 430 470 MHz 28 V m 28 V m LTE Band 13 17 704 787 MHz 9 V m 9 V m GSM 8...

Страница 13: ... protection in the area of the arm that will be in contact with the stimulation device Ensure that the protective layer covers the skin and avoids direct contact between it and the stimulation device The stimulator is posteriorly equipped with an elastic band to be positioned around the right or left arm based on the side of the pathology to be rehabilitated Make sure Velcro fixing is stable on th...

Страница 14: ...5 seconds P1 Training 7 seconds P2 Training 9 seconds P3 Training 11 seconds P4 Only for the SPM01K2 SPM01K3 SPM01K4 kits Wireless mode W The Manual Operating program M is performed at the beginning of the usage session to let the patient familiarize with the muscle sensation induced by stimulation The program allows the user to adjust the intensity of stimulation with a wheel followed by a phase ...

Страница 15: ...rt immediately after selecting the program The selection of the program must be confirmed by pressing the button As long as the choice is not confirmed the red led in correspondence of the selected program is in flashing mode If the program has been erroneously selected do not confirm the selection with the button and turn the wheel to return to the program selection phase START OF STIMULATION The...

Страница 16: ...ditions static phases and then activate it again when these conditions are no longer verified To establish the level of stimulation initially the subject manually chooses the maximum tolerated stimulation value Manual selection implies that the subject by rotating the wheel progressively increases the intensity of the stimulation Once the maximum tolerated intensity level has been reached the subj...

Страница 17: ...t the stimulator is switched off Proceed by disconnecting the conductive cables from the stimulator and insert the USB charging cable in the space provided Then connect the cable to a power supply capable of delivering 5V and at least 275mA Wait until the device has been recharged signaled by the complete lighting of the red LED band REPLACEABLE PARTS The replaceable parts of the system which requ...

Страница 18: ...ge the position of the electrodes slightly Stimulation causes discomfort The electrodes lose their adhesiveness and no longer provide adequate contact with the skin then they must be replaced The electrodes are worn and must be replaced Change the position of the electrodes slightly The device does not work Check that the device is charged If the device still does not work contact our customer ser...

Страница 19: ...REF V 25 50 75 100 125 150 maximum value FSTIM Hz 35 typical value TSTIM μs 100 typical value ZLOAD Ω 500 extreme precautionary value 2000 typical value 5000 Table 5 Stimulation parameters and load resistances considered in the example tables ZLOAD 500 Ω TSTIM 100 μs FSTIM 35 Hz VREF 25 50 75 100 125 150 VPEAK V 24 43 48 85 73 28 97 71 122 13 146 56 VEFF_STIM V 10 06 20 11 30 17 40 23 50 29 60 34 ...

Страница 20: ...re and system updates and for software problems troubleshooting during product use contact the NCS Lab support team info ncs company com info shoulderpacemaker com 39 059 669813 Via Pola Esterna 4 12 41012 Carpi MO The e mails sent to the above address will be replied within 48 hours ...

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