SHOULDER PACEMAKERTM - User Manual 04-06EN 2
SHOULDER PACEMAKERTM - User Manual 04-06EN SUMMARY THE FUTURE OF STIMULATION 4 DISCLAIMER 4 INTRODUCTION 5 MAIN FEATURES 6 INTENDED USE 6 PERSON DESIGNATED AS THE SUBJECT OF THE TREATMENT 6 USED MATERIAL 6 ENVIRONMENTAL REQUIREMENTS 7 SECURITY MEASURES 7 REGULATIONS 8 INFORMATION TO THE USER 8 RF RADIATOR EXPOSURE STATEMENT 8 PRODUCT DESCRIPTION MATERIAL AND ACCESSORIES SUPPLIED 8 8 TECHNICAL FEATURES 10 INSTRUCTIONS FOR USE 13 FUNCTIONING OF THE DEVICE 15 DEVICE DESCRIPTION
SHOULDER PACEMAKERTM - User Manual 04-06EN THE FUTURE OF STIMULATION TM Welcome to the future and thank you for choosing Shoulder Pacemaker . TM Shoulder Pacemaker is the most innovative product for the stimulation of scapular muscles. TM Shoulder Pacemaker is a wearable neuromuscular stimulator. TM Shoulder Pacemaker brings electrical stimulation of the scapular muscles to a new level of rehabilitation. DISCLAIMER TM Please read this manual carefully before using the device Shoulder Pacemaker .
SHOULDER PACEMAKERTM - User Manual 04-06EN INTRODUCTION The shoulder is a very complex joint, mainly stabilized by the coordinated activation of several muscles that keep the joint in position. If this control system fails, severe dyskinesia, functional restrictions, and instability can occur. TM The Shoulder Pacemaker device is an electrical muscle stimulator, internally powered and used for medical purposes.
SHOULDER PACEMAKERTM - User Manual 04-06EN MAIN FEATURES TM TM What is Shoulder Pacemaker ? Shoulder Pacemaker is a muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction through the passage of electric current by means of conductive electrodes positioned on the body area of interest.
SHOULDER PACEMAKERTM - User Manual 04-06EN WARNING: Never apply the electrodes: near the head on the front and side of the neck in a contralateral position (i.e. with the two poles placed on opposite segments of the body) on or near injuries of any kind (sores, edemas, burns, irritations, eczema, tumor lesions, etc.
SHOULDER PACEMAKERTM - User Manual 04-06EN During the stimulation session, do not disconnect any part of the device in tension. You must first turn off the device To recharge the device always use the cable supplied by the manufacturer TM Do not use the Shoulder Pacemaker device or the charging cable if they are damaged or open.
SHOULDER PACEMAKERTM - User Manual 04-06EN For wireless mode feature, it is necessary to use a laptop on which the Shoulder Pacemaker Control software 1.1.2.0 is installed or an Android mobile phone/tablet on which the MySPM or MySPM@Home applications is installed. The Shoulder Pacemaker Control 1.1.2.0 software must be installed on a computer with one of the following operating systems: MS Windows 7, MS Windows 8, MS Windows 8.1, MS Windows 10.
SHOULDER PACEMAKERTM - User Manual 04-06EN The device has a degree of protection for the casings of electrical equipment equal to IP 22 (protected against solid bodies greater than 12mm in diameter, protected from falling drops of water with a maximum tilt of 15°). TM The FCC ID of the Shoulder Pacemaker is 2ATZJ-SPM and it is affixed in the back side of the device as show in the figures.
SHOULDER PACEMAKERTM - User Manual 04-06EN Guidance and manufacturer's declaration - electromagnetic emissions TM Shoulder Pacemaker 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.
SHOULDER PACEMAKERTM - User Manual 04-06EN Guidance and manufacturer's declaration - electromagnetic immunity TM Shoulder Pacemaker 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.
SHOULDER PACEMAKERTM - User Manual 04-06EN INSTRUCTIONS FOR USE We strongly recommend that you carefully read the contraindications and safety measures described in the "Intended Use" chapter of this manual. WARNING: Use this device only with cables, electrodes and accessories recommended by NCS Lab. Preliminary checks • Make sure the stimulator battery is fully charged before each use session. • Make sure that at least 2 electrodes are available to stimulate the muscles of interest.
SHOULDER PACEMAKERTM - User Manual 04-06EN The most correct procedure would be to start from a low level and then increase to a higher level when switching to a new electrostimulation cycle. At the end of a cycle you can start either a new cycle with the next higher level, or carry out a session maintenance training with the last level used. The maximum stimulation level delivered by the stimulator is 150V.
SHOULDER PACEMAKERTM - User Manual 04-06EN FUNCTIONING OF THE DEVICE DEVICE DESCRIPTION The device is managed by rotating the wheel (a) and pressing the button (b). The status of the device (on, off, stimulation, charging) is indicated by the yellow led in the center of the device (c). The management of the menu and the regulation of the intensity of the stimulation are revealed by the turning on, off or flashing of the band of the red leds (d), that are switched on in sequence according to wheel rotation.
SHOULDER PACEMAKERTM - User Manual 04-06EN ALARMS Alarm activation is signaled by the lighting of the red led placed as described in (e). For a low charge level, this red led lights up in permanent flashing mode to indicate to the user the battery status and therefore the need to stop stimulation. This led lights up when the battery charge level falls below a specific critical threshold value (20%) for the battery.
SHOULDER PACEMAKERTM - User Manual 04-06EN Refer to the specific user manuals on the management of the Shoulder Pacemaker Control Software 1.1.2.0 supplied with the SPM01K2 kit or on using the app MySPM supplied with the SPM01K3/SPM01K4 kit The Basic Instructions described above remain valid even in wireless mode.
SHOULDER PACEMAKERTM - User Manual 04-06EN TROUBLESHOOTING Stimulation does not produce the usual feeling Check that all settings are correct Check that the electrodes are positioned appropriately Change 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 do
SHOULDER PACEMAKERTM - User Manual 04-06EN APPENDIX A The following tables set out some relevant quantities calculated using a simplified stimulation circuit analysis for settable stimulation reference parameters. The following quantities are considered.
SHOULDER PACEMAKERTM - User Manual 04-06EN CONTACTS For more information on software 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.
