SHOULDER PACEMAKER
TM
- User Manual 04-06EN
8
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
Do not use the Shoulder Pacemaker
TM
device or the charging cable if they are damaged or open. There is a risk of electrical discharge
Immediately disconnect the power supply in case of temperature increase or abnormal odors, or if smoke comes from the adapter or
from the appliance
Do not place the device in the recharging area in a confined space. There is a risk of electrocution
Keep the Shoulder Pacemaker
TM
device out of reach of children and animals
Do not allow any foreign body (earth, water, metal, etc.) to enter the device
Do not apply stimulation during sleep
Do not use the stimulator while driving or operating machinery
Do not use the device directly in contact with the patient's arm, place a medical device certified skin-saving adhesive layer
REGULATIONS
To guarantee the safety of users, the Shoulder Pacemaker
TM
device was designed, manufactured and distributed in compliance with the
amended European directive 93/42/EEC concerning medical devices.
The Shoulder Pacemaker
TM
device also complies with the IEC 60601-1 standard relating to the general safety requirements for electromedical
equipment, to the IEC 60601-2 standard on electromagnetic compatibility, to the IEC 60601-2-10 standard on particular safety rules for
neuromuscular stimulators and to the CEI EN 60601-1-11 on the home use of electro-medical equipment..
The Shoulder Pacemaker
TM
device also complies with the European Directive 2012/19/EU on Waste Management from Electrical and
Electronic Equipment (WEEE). All products bearing the WEEE mark must be separated from household waste and sent to special collection and
recycling stations. It is mandatory to follow the common procedures adopted within your own hospital, clinic and home, in order to properly
dispose of it.
INFORMATION TO THE USER
1. For devices approved under Part 15, the user’s manual or instruction manual for an intentional or unintentional radiator shall caution the
user about changes or modifications to the device (Section 15.21).
2. For Class A and Class B digital devices, information to the user is required to include the following statements (Section 15.105):
NOTE: This equipment has been tested and found to comply 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, 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 following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the
equipment.
RF RADIATOR EXPOSURE STATEMENT
The device Shoulder Pacemaker should be installed and operated with minimum distance of 5 mm between the radiator and your body. The
case of the device guarantees the fulfillment of this requirement and therefore allows its direct application on the body by means of elastic
bands.
PRODUCT DESCRIPTION
MATERIAL AND ACCESSORIES SUPPLIED
READ CAREFULLY
– A user manual is provided together with the device. It serves as the main reference for both hardware and software use. It
is essential that the user and all personnel involved in using the product fully understand the contents of the manual and follow the
instructions provided during all phases of the implemented protocol.
The Shoulder Pacemaker
TM
product can be used in
stand-alone mode
or in
wireless mode
. In the wireless mode the device is provided in
combination with an usb receiver and a dedicated control software executed on a pc/laptop or with a mobile phone/tablet application
according to the sales kit.
For only stand-alone mode version, the content of the SPM01K1 kit is:
1 electrostimulator (REF: SPM01);
1 elastic band;
1 pair of conductor cables (code SPM-S);
1 charging cable (code SPM-C);
2 bags of pre-sealed electrodes for electrostimulation with standard clip coupling with 4mm head and conductive surface not less
than 5cm2 (Medical device according to Directive 93/24/EEC);
1 pack of protective skin protection system (Medical device according to Directive 93/24/EEC).
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