Saebo SaeboStim Pro User manual

INSTRUCTION MANUAL
Saebo
SaeboStim Pro

SaeboStim Pro Introduction
Saebo
1
Introduction
Saebo is pleased to provide you with the SaeboStim Pro, a functional
electrical stimulation device designed to minimize muscle weakness, improve
function, and re-educate and strengthen weakened muscles.
The SaeboStim Pro complements the Saebo program. Whether applying the
stimulation before or after the Saebo treatment or combining stimulation with
the Saebo technology, providing multiple evidence-based treatment solutions
can enhance overall functional recovery.
This manual contains important information for both the person who will use
the SaeboStim Pro and the clinician who may provide and setup the device.
Please consult your physician prior to starting treatment with the SaeboStim
Pro. Please be sure to review all information carefully.
If you have questions or require further information, please contact:
Saebo, Inc.
2459 Wilkinson Boulevard, Suite 120-B
Charlotte, NC 28208
Tel: [phone]
www.saebo.com

SaeboStim Pro
Index
Introduction .................................................................................................... 1
List of Symbols ............................................................................................ 3,4
Contraindications ....................................................................................... 4 - 6
Warnings ..................................................................................................... 6,7
Adverse Reactions ........................................................................................... 7
EMC, Caution .................................................................................................. 8
Guidance and Manufacture's Declaration.................................................... 9 -17
Intended Use ................................................................................................ 19
Description of Device and Controls .......................................................... 20, 21
Display Screen Symbols and Description ................................................... 22,23
Getting Started .............................................................................................. 24
Installing Batteries ........................................................................................ 25
Clean Skin ..................................................................................................... 26
Plug in Electrode Wires ............................................................................. 26, 27
Powering the SaeboStim Pro ........................................................................ 28
Select and Start a Program ...................................................................... 29-35
Sensory Electrical Stimulation (SES) Program ............................................ 36,37
Usage of Electrical Pads ................................................................................ 38
Care and Maintenance .............................................................................. 39,40
Program Information ............................................................................... 42 -46
Troubleshooting ........................................................................................... 47
Technical Support, Warranty ......................................................................... 48
Index

SaeboStim Pro
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other household waste
Refer to user manual
Serial Number
 Thenumberofthenotiedbody(0123)
European Authorized Representative
3
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual

SaeboStim Pro
Contraindications
• If you are in the care of a physician, consult with your physician before using
this device.
• If you have had medical or physical treatment for your pain, consult with your
physician before using this device.
• Do not apply stimulation over your neck because this could cause severe
 musclespasmsresultinginclosureofyourairway,dicultyinbreathing,or
 adverseeectsonheartrhythmorbloodpressure.
• Do not apply stimulation across your chest because the introduction of
electrical current into the chest may cause rhythm disturbances to your heart,
which could be lethal.
• Do not apply stimulation over open wounds or rashes, or over swollen, red,
 infected,orinamedareasorskineruptions(e.g.,phlebitis,thrombophlebitis,
varicose veins).
List of Symbols (continued)
Fragile
Keep upward
Keep dry
The protection level against water is IP22
4
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
List of Symbols
Contraindications, that may cause danger
Mandatory requirement or may cause an injury or physical
discomfort
Type BF Equipment
Use with Caution
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This product must not be disposed of with other
household waste
Refer to user manual
IP22

SaeboStim Pro
Contraindications (continued)
• Do not apply stimulation over, or in proximity to, cancerous lesions.
• Do not apply stimulation over metal implants.
• 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 device is in use.
• Donotusethisdeviceifyouhaveacardiacpacemaker,implanteddebrillator,
or other implanted metallic or electronic device. Such use could cause electric
shock, burns, electrical interference, or death.
• Do not apply stimulation when in the bath or shower.
• Do not apply stimulation while driving, operating machinery, or during any
activity in which electrical stimulation can put you at risk of injury.
• Do not use the device on children, if it has not been evaluated for pediatric use.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not use near short-wave, microwave. (such as 1m)
• Patients with heart disease, severe hypertension and skin disorder are forbidden
to use this product.
• Patients with epilepsy are forbidden to use this product.
• Patientswithactivehemorrhage,acutepurulentInammation,malignant 
neoplasms, thrombophlebitis, sepsis and cardiopulmonary failure are forbidden
to use this product.
• Do not use this product for purpose other than treatment.
• Do not apply this product to unconscious patients.
• Do not disassemble, repair or rebuild this product.
• Do not touch the charging connector/battery and the patient simultaneously
when charging/using.
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SaeboStim Pro
Contraindications (continued)
• Stimulation should not be applied over the carotid sinus nerves, particularly in
 patientswithaknownsensitivitytothecarotidsinusreex.
• Stimulation should not be applied over the neck or mouth. Severe spasm of the
laryngeal and pharyngeal muscles may occur and the contractions may be strong
 enoughtoclosetheairwayorcausedicultyinbreathing.
• Stimulation should not be applied transthoracically in that the introduction of
electrical current into the heart may cause cardiac arrhythmias.
• Stimulationshouldnotbeappliedoverswollen,infected,orinamedareasor
skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
Warnings
• The safety of electrical stimulation during pregnancy has not been established.
• You may experience skin irritation or hypersensitivity due to the electrical
stimulation or electrical conductive medium (gel).
• If you have suspected or diagnosed heart disease, you should follow precautions
recommended by your physician.
• If you have suspected or diagnosed epilepsy, you should follow precautions
recommended by your physician.
• Use caution if you have a tendency to bleed internally, such as following an
injury or fracture.
• Consult with your physician prior to using the device after a recent surgical
procedure, because stimulation may disrupt the healing process.
• Use caution if stimulation is applied over areas of skin that lack normal
sensation.
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SaeboStim Pro
Warnings (continued)
• Keep this device out of the reach of children.
• Use this device only with the gel pads and accessories recommended by the
manufacturer.
• Please use with caution when the output current density exceeds 10mA/cm2
(r.m.s).
• Please use with caution if the used areas have structural deformity.
• Patients should not move the electrode while using this stimulator.
• Please stop using this product if the body shows any physical abnormality.
• If the device has been stored in a cold or hot environment, allow it at least
5 minutes to acclimate to room temperature before operating.
Helpful Hint: Patients with sensory loss should not over-stimulate.
Consult your health professional for proper setup and protocol.
Adverse Reactions
• Skin irritation and burns beneath the electrodes have been reported with the use
of powered muscle stimulators.
• You should stop using the device and should consult with your physician if you
experience any adverse reactions from the device or electrodes.
• It is normal to get some skin reddening after a session. This fades quickly.
• You should always take rests between therapy sessions. If the reddening does
not disappear after a couple hours, discontinue use of the system, and contact
www.saebo.com.
• There is a small percentage of people that may have allergic reactions to gel and
will need special hypo allergic gels. 7

SaeboStim Pro
• If any skin irritation or allergy occurs, please stop using the stimulator
 immediatelyandfollowdoctor’sinstructions.
• Do not position on allergic area.
Electromagnetic Compatibility (EMC)
This equipment generates, uses, and radiates radio frequency energy. The equipment
may cause radio frequency interference to other medical or non-medical devices and
to radio communications.
If this equipment is found to cause interference, which can be determined by turning
onandotheequipment,theoperatororqualiedservicepersonnelshouldtake
following actions:
• Reorientorrelocatetheaecteddevice;
 • Increasethedistancebetweentheequipmentandtheaecteddevice;
 • Powertheequipmentbyanothersource;
• Consult the service engineer for further suggestions.
Caution
 • Itisthecustomer’sresponsibilitytoassurethatthisequipmentandvicinity
equipment comply with the contents of IEC 60601-1-2 4th Edition.
• Do not use any device that might send out RF signals, including cell
phone, radio transceiver and radio control products, which might cause
operation parameters beyond the standards. please shutdown these devices
when you are near the equipment. Operator has the responsibility to warn
user or any others to comply with this rule.
• Manufacturer will not responsible for any unauthorized actions that cause
interference.
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