10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo
®
, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo
®
until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo
®
if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo
®
at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo
®
muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo
®
controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
10
INDICATION FOR USE:
The Innovo
®
is a non-implanted Neuromuscular Electrical Stimulator indicated for the strengthening of the pelvic floor
muscles in the treatment of stress urinary incontinence in adults. The Innovo
®
is indicated for prescription use only.
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other heart
problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic
area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not been
established.
• Do not use if you suffer from cancer, epilepsy or are under medical supervision for cognitive dysfunction.
• Do not use in close proximity (e.g. 1m) to shortwave or microwave therapy equipment, as this may produce
instability in the controller’s output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are administered
by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of the
gel pads and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the
front of the neck, (especially the carotid sinus), or from gel pads placed on or across the chest and the upper
back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to the
introduction of electrical current into the heart.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical
stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms),
which may not operate properly when the electrical stimulation controller is in use.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the garments, leads, gel pads, and accessories recommended by the manufacturer.
• For hygiene reasons the gel pads and garments are for single person use only. To prevent cross-infection, gel
pads and garments should not be shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to Innovo®, other than those supplied by Bio-Medical Research. Never
connect any computer leads to the controller.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or other
vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the gel pads directly over metal implants.
• For use by adults only.
• To avoid risk of choking keep gel pads, lanyard, packaging and small parts which may be broken off out of
reach of children.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the gel pads or metal studs with your fingers while the controller is switched on.
• The studs, treatment cableand gel pads must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel
pads. The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets or pests.
Please wait before using your Innovo® until:
• At least six weeks after the birth of your baby (you must consult your prescribing practitioner first).
• At least three months after having a caesarean section (you must consult your prescribing practitioner first).
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using Innovo® if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedures and where muscle contraction may disrupt the healing process;
To reposition the belt or GelPads during a session:
• Always pause the device, unfasten the garment(s) and then refasten it once the position of the gel pads has
been adjusted
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the gel pad during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
being with.
• Use of muscle stimulation devices at a high intensity can be associated with minor transient discomfort.
Ensure you used your Innovo® at a level which is comfortable to you. An effective treatment should not cause
undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Bio-Medical Research will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the Innovo® muscle stimulator provided with instructional manual which is
proprietary to Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each Innovo® controller is assigned a unique serial number,
which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
Shows which program is currently selected.
(Type 208 has one program installed.)
CONTROLLER DISPLAY
Pantalla completa con todos los iconos visualizados
Battery Power indicator:
Shows the remaining battery power.
Warning indicator:
Indicates that there is a problem with your
product - with the leads, shorts, integrated
electrodes or the controller itself.
Keylock symbol:
Appears when Keylock has been activated to
indicate that the chosen programme or intensity
level cannot be accidentally changed.
Mute symbol:
Indicates that the sound is off.
Treatment sessions:
Number of treatment sessions completed.
Treatment timer:
Displayed when viewing the total treatment
time, or the duration of a treatment session.
Maximum intensity:
This is displayed when viewing the highest
intensity reached to date, or in a particular
treatment session.
Average intensity indicator:
This is displayed when viewing the
average of all treatment sessions run to
date.
Pause symbol:
Appears whenever a treatment session
has been paused.
Programme indicator:
Shows which programme is currently
selected.
Individual treatment session indicator:
Displays each session (1-90).
Intensity indicator:
Appears during each contraction phase.
Intensity/time indicator:
Displays intensity level from each channel
and treatment time remaining.
Controller indicator:
Shows what type of information is being
displayed by the intensity/time indicator.
Electrode contact indicator:
Indicates electrodes are in poor contact
with the skin. See page 21 for more
details.