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SHOULDER PACEMAKER

TM

 - 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. 

The Shoulder Pacemaker

TM

 device is an electrical muscle stimulator, internally powered and used for medical purposes. The  device induces 

muscle  contractions  by  means  of  passage  of  electric  current  through  conductive  electrodes  positioned  on  the  body  areas  of  interest.  The 
Shoulder Pacemaker

TM

 device can be used to stimulate the shoulder and periscapular musculature in patients with non-physiological muscle-

activation pattern.  

Electrostimulation  in  general  is  an  effective  training  method  for  muscles.  The  Shoulder  Pacemaker

TM

  is  primarily  designed  to  re-educate 

patients in terms of their muscle activation pattern. Focus group is rapresented by posterior shoulder instability patients without any structural 
defects to bone, tendons, muscles or nerves that merely suffer from a malcoordination of their muscle activation leading to severe instability 
symptoms.  In  this  particular  patient  group  preliminary  results  have  been  very  encouraging  (1,2).  Furthermore,  the  Shoulder  Pacemaker

TM

 

device can as well be used in other pathologies including but not limited to preoperative and postoperative muscle strengthening for different 
types of shoulder surgery. There is evidence that electrical muscle stimulation treatment has a positive effect on infraspinatus and shoulder 
external rotation force production after rotator cuff repair surgery (3) or infraspinatus strength in a non-operative setting as well (4). Even in 
reverse shoulder prosthesis preoperative and postoperative muscle strangthening has been shown to improve the clinical outcome (5) making 
the  application  of  electrical  muscle  stimulation  in  these  patients  feasible.  It  would  seem  that  in  neurological  patients,  the  benefits  of  the 
electrostimulation could be lower than in the orthopaedic patients as nerve lesions lead to muscle disactivation, atrophy and fatty infiltration 
with partial or complete loss of function that can be irreversible. Nonetheless, research has shown that even in patients with hemiparetic or 
hemiplegic  shoulder  pain,  subluxation  and  loss  of  function  due  to  stroke,  electrical  muscle  stimulation  treatment  can  improve  muscle 
activation, reduce pain and improve 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 and timing of 
intervals of their motion to the electrical impulse. This limitation is overcome by the Shoulder Pacemaker

TM

 device thanks to the fact that the 

movements performed by the subject's arm are identified by sensors placed inside the device, and the stimulation is automatically adapted to 
the patients motion thus greatly improving the applicability during a dedicated exercise program. The training performed with the Shoulder 
Pacemaker

TM

  device  aimes  at  automated  activation  of  hypoactive  muscle  groups  during  motion  with  the  goal  to  help  the  users/patients  to 

retrain their muscle activation pattern by means of a feed-forward mechanism. 
 

(1) Moroder et al, Use of shoulder pacemaker for treatment of functional shoulder instability, Obere Extremität (2017), 12(2): 103-108 
(2)Moroder  et  al,  Shoulder-Pacemaker  Treatment  Concept  for  Posterior  Positional  Functional  Shoulder  Instability,The  American  Journal  of 
Sports Medicine (2020), 48(9): 2097-2104 
 (3) Reinold et al, The effect of neuromuscular electrical stimulation of  the infraspinatus on shoulder external rotation force production after 
rotator cuff repair surgery, The American Journal of Sports Medicine (2008), 36(12): 2317-2321 
(4)  Yanase  et  al,  Electrical  Stimulation  to  the  Infraspinatus  on  Hypertrophy  and  Strenght  of  the  Shoulder,  International  Journal  of  Sports 
Medicine (2018), 39(11): 828-834 
(5) Uschok et al, Reverse shoulder arthroplasty: the role of physical therapy on the clinical outcome in the mid-term to long-term follow-up, 
Archives of Orthopaedic and Trauma Surgery (2018), 138(12): 1647-1652 
(6) Jeon et al, The effects of electromyography-triggered electrical stimulation on shoulder subluxation, muscle activation, pain, and function in 
persons with stroke: A pilot study, Neurorehabilitation (2017), 40(1): 69-75 

(7) Chuang et al, Effect of EMG-triggered neuromuscular electrical stimulation with bilateral arm training on hemiplegic shoulder pain and arm 
function after stroke: a randomized controlled trial, Journal of NeuroEngineering and Rehabilitation (2017), 14(1):122 

(8) Wilson et al, The effect of Peripheral Nerve Stimulation on Shoulder Biomechanics: A Randomized Controlled Trial in Comparison to Physical 
Therapy, American Journal of Physical Medicine & Rehabilitation (2017), 96 (3): 191-198

 

 

Summary of Contents for SHOULDER PACEMAKER SPM Series

Page 1: ......

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

Page 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 ...

Page 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...

Page 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 ...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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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