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.
5

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.
6

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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SaeboStim Pro
Table 1
GuidanceandManufacture’sDeclaration–ElectromagneticEmission
Thisequipmentisintendedforuseintheelectromagneticenvironmentspecied
below. User should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment -
guidance
RF emissions
CISPR 11
Group 1 This equipment uses RF energy
only for its internal function.
Its RF emissions are very low
and are not likely to cause any
interference in nearby electronic.
RF emissions
CISPR 11
Class B This equipment is suitable for
domestic establishments and
those directly connected to the
public low-voltage power supply
network.
Harmonic emissions
IEC 61000-3-2
Class A
Voltageuctuations/icker
emissions
IEC 61000-3-3
Complied
9

SaeboStim Pro
Table 2
GuidanceandManufacture’sDeclaration–ElectromagneticImmunity
Thisequipmentisintendedforuseintheelectromagneticenvironmentspecied
below. User should assure that it is used in such an environment.
Immunity test IEC60601 test
level
Compliance
level
Electromagnetic environment -
guidance
Electrostatic
discharge
(ESD)
IEC 61000-
4-2
±8kV contact
±2kV, ±4kV,
±8kV, ±15kV air
±8kV contact
±2kV, ±4kV,
±8kV, ±15kV
air
Floors should be wood, concrete
or ceramic tile. Humidity should
be at least 30% if it is synthetic
materials.
Electrical fast
transients/
bursts (EFT)
IEC 61000-
4-4
±2kV
100kHz
repetition
frequency
±2kV
100kHz
repetition
frequency
Main power quality should be
that of a typical commercial or
hospital environment.
Surges
IEC 61000-
4-5
±0.5kV, ±1kV
line-to-line
±0.5kV, ±1kV,
±2kV line-to-
ground
±0.5kV, ±1kV
line-to-line
±0.5kV, ±1kV,
±2kV line-to-
ground
10

SaeboStim Pro
Table 2 (Continued)
Voltage dips
IEC 61000-4-11
0%UT;0.5
cycle
At 0°, 45°, 90°,
135°, 180°,
225°, 270° and
315°
0%UT;0.5cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
Mains power quality should
be typical commercial or
hospital environment. UPS
power is recommended if
this device needs to be used
continuously.
0%UT;1cycle
and
70%UT;25/30
cycles
Single phase:
at 0°
0%UT;1cycle
and
70%UT;25/30
cycles
Single phase: at 0°
Voltage
interruptions
IEC 61000-4-11
0%UT;250/300
cycle
0%UT;
250/300 cycle
RATED power
frequency
magneticelds
IEC 61000-4-8
30A/m
50Hz or 60Hz
30A/m
50Hz or 60Hz
Power frequency magnetic
eldsshouldbeatlevels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: UT is the A.C. mains voltage prior to application of the test level.
11

SaeboStim Pro
Table 3
GuidanceandManufacture’sDeclaration–ElectromagneticImmunity
Thisequipmentshouldbeusedintheelectromagneticenvironmentspeciedbelow.
User should assure that it is used in such an environment.
Immunity
test
IEC60601 test
level
Compliance
level
Electromagnetic environment -
guidance
Conducted
RF
IEC 61000-
4-6
3Vrms
150 kHz to 80
MHz
3Vrms Portable and mobile RF
communications equipment should
be used no closer to any parts than
the recommended separation distance
that calculated from the equation
applicable to the frequency of the
transmitter.
6Vrms
in ISM and
amateur radio
bands between
150 kHz and 80
MHz (a)
6Vrms Recommended separation distance:
Pd 2.1=
150 kHz to 80 MHz
Pd 2.1=
80MHz to 800 MHz
Pd 3.2=
800MHz to 2.7GHz
Radiated RF
IEC 61000-
4-3
10 V/m
80MHz to
2.7GHz
10 V/m
EPd /6=
at RF wireless communications
equipment bands (Portable RF
communications equipment
12

SaeboStim Pro
Table 3 (Continued)
(including peripherals such as antenna
cables and external antennas) should
be used no closer than 30 cm (12
inches) to any part of the device).
Where “P” is the maximum output
power rating of the transmitter
in watts according to transmitter
manufacturer and “d” is the
recommended separation distance
inmeters.Fieldstrengthsfromxed
RF transmitters, as determined by an
electromagnetic site survey (b), should
be less than the compliance level in
each frequency range (c).
Interference may occur in the vicinity
of equipment marked with the
following symbol:
Note1: At 80MHz and 800MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is
aectedbyabsorptionandrefectionfromstructures,objectsandpeople.
13

SaeboStim Pro
Table 3 (Continued)
a)TheISM(industrial,scienticandmedical)bandsbetween0.15MHzand80MHzare
6.765MHzto6.795MHz;13.553MHzto13.567MHz;26.957MHzto27.283MHz;
and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80
MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3
MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz,21.0
MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to
54.0 MHz.
b)Fieldstrengthsfromxedtransmitters,suchasbasestationsforradio(cellular
/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess
theelectromagneticenvironmentduetoxedRFtransmitters,anelectromagnetic
sitesurveyshouldbeconsidered.Ifthemeasuredeldstrengthinthelocationin
which this is used exceeds the applicable RF compliance level above, this should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating.
c) Field strengths should be less than 3V/m in the frequency range of 150k-80MHz.
14

SaeboStim Pro
Table 4
TestSpecicationsforENCLOSUREPORTIMMUNITYtoRFWirelessCommunications
Equipment.
Test
Frequency
(MHz)
Band a)
(MHz)
Service a) Modulation b) Maximum
Power
(W)
Distance
(m)
ImmunIty
TEST LEVEL
(V/m)
385 380 - 390 TETRA 400
Paulse
modulation b)
18 Hz
1.8 0.3 27
450 430 - 470 GMRS 460,
FRS 460
FM C)
± 5 kHz
deviation
1 kHz sine
20.3 28
710
704 - 787 LTE Band 13,
17
Pulse
modulation b)
217 Hz
0.2 0.3 9745
780
810
800 - 960
GSM 800/900,
TETRA 800,
IDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz
20.3 28
870
930
1 720
1 700 -
1 990
GSM1800;
CDMA1900;
GSM1900;
DECT;
LTE Band 1, 3,
4,25;UMTS
Pulse
modulation b)
217 Hz
20.3 28
1 845
1 970
15

SaeboStim Pro
Table 4 (Continued)
2 450 2 400 -
2 570
Bluetooth,
WLAN,
802.11 b/g/n.
LTE Band 7
Pulse
modulation b)
217 Hz
20.3 28
5 240
5 100 -
5 800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0.2 0.3 95 500
5 785
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the
transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m test
distance to permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz be used because while
it does not represent actual modulation, it would be worst case.
Table 5
Recommended Separation Distance between Portable and Mobile RF
Communications Equipment and the Nerve and Muscle Stimulator
The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the Nerve and Muscle
Stimulator as recommended below, according to the maximum output power of the
communications equipment.
16

SaeboStim Pro
Table 5 (Continued)
This device can be used under the environment that radiated RF disturbances are
controlled. User should maintain a minimum distance between portable and mobile
RF communications equipment to prevent electromagnetic interference. Following
recommended distance is calculated according to the maximum output power of the
communication equipment.
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of transmitter (m)
150kHz-80MHz
Pd 2.1=
80MHz -800MHz
Pd 2.1=
800MHz -2.7GHz
Pd 3.2=
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance “d” in meters can be estimated using the equation applicable to the
frequency of transmitter, where “P” is the maximum output power rating of the transmitter
in watts according to the transmitter manufacturer.
Note1: At 80M and 800MHz, the separation distance for the higher frequency range
applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is
aectedbyabsorptionandrefectionfromstructures,objectsandpeople.
17

SaeboStim Pro
18