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Saebo SaeboStim Pro Instruction Manual Download Page 5

Sae

bo

Stim 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 notified 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 

Summary of Contents for SaeboStim Pro

Page 1: ...INSTRUCTION MANUAL Saebo SaeboStim Pro ...

Page 2: ......

Page 3: ... 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 informat...

Page 4: ...vice 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 In...

Page 5: ...t Type BF Equipment Use with Caution Non Ionizing Radiation Date of Manufacture Manufacturer This product must not be disposed of with other household waste 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 t of Symbols Contraindicatio...

Page 6: ...ontinued 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 C...

Page 7: ...ery 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 ...

Page 8: ...s 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 h...

Page 9: ...fore 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...

Page 10: ...ons Reorient or relocate the affected device Increase the distance between the equipment and the affected 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 ...

Page 11: ...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 ...

Page 12: ...tic 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 environme...

Page 13: ...tinuously 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 fields IEC 61000 4 8 30A m 50Hz or 60Hz 30A m 50Hz or 60Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or h...

Page 14: ... 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 P d 2 1 150 kHz to 80 MHz P d 2 1 80MHz to 800 MHz P d 3 2 800MHz to 2 ...

Page 15: ...nded separation distance in meters Field strengths from fixed 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 Elec...

Page 16: ... strengths from fixed 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 fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in whi...

Page 17: ...0 390 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 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation b 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 IDEN 820 CDMA 850 LTE Band 5 Pulse modulation b 18 Hz 2 0 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 2...

Page 18: ...e 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 ...

Page 19: ...Hz P d 2 1 80MHz 800MHz P d 2 1 800MHz 2 7GHz P d 3 2 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 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 a...

Page 20: ...SaeboStim Pro 18 ...

Page 21: ...mmediate post surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion In addition Transcutaneous Electrical Nerve Stimulation TENS is used as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems and chronic pain syndroms SaeboStim Pro Features 2 Independent Channels 10 NMES Programs 3 TENS Programs...

Page 22: ...ity level or activate the Trigger Mode in Channel A If icon B is flashing on the screen the user can set the Intensity level or activate the Trigger Mode in Channel B The flashing will stop following 10 seconds of no operation 3 Pause Trigger Key The Pause Trigger Key T serves both functions Pause When the stimulator is running a treatment program press the Pause Trigger Key once to pause the trea...

Page 23: ...tput intensity The Lock icon will display on the screen Press and hold for 2 seconds to unlock the intensity keys The lock icon will disappear from the screen 5 Intensity Once the desired Channel Key is pressed and flashing press the Intensity Keys to the corresponding Channel to adjust the intensity levels in the treatment The intensity increment is 1 mA Pressing button during treatment increases...

Page 24: ... into the ports on the top portion of the device 8 DC Jack The stimulator can be powered though the USB cord For USA shipments only an AC adaptor will also be provided Connect one end to a power source and other to the connector on the left side of the unit 1 5 2 3 4 8 9 9 6 6 9 10 Figure 2 22 ...

Page 25: ...ntensity Bar when activated the intensity bar will increase and decrease corresponding to the contraction and relaxation cycle on each Channel 7 P1 indicates the current treatment program 8 Time length of time remaining 9 Arrow when Trigger Mode is activated an arrow symbol will appear below the corresponding Channel 10 FWSRT custom icons appear when pressing the Program Key for 3 seconds Descript...

Page 26: ...ct between the device and the Electrode Pads Electrode Pads The Electrode Pads are connected to the stimulator through the Electrode Wires providing stimulation to the desired muscle Power Adapter Power Cord This supplies power for the stimulator when it is not powered by batteries The Power Adapter is for US customers only Carrying Case The stimulator can be stored securely in the Carrying Case B...

Page 27: ...compartment and slide firmly to remove See Figures 4 5 A directional arrow on the battery cover indicates the direction in which the cover opens The correct poles and how to insert the battery is marked by the image of a battery and its connections in the compartment To close the battery compartment slide the battery cover so the connections meet and let it click in by applying slight pressure Re ...

Page 28: ...rt is on the skin Plug in Electrode Wires The Electrode Wires provided with the unit are inserted into the Output Ports OUT A OUT B located at the top of the Stimulator The wire connectors have been designed so they will insert and connect firmly into place If only one Electrode Wire is needed plug it into Outlet A See Figures 6 7 Figure 6 Figure 7 26 ...

Page 29: ...sition on Skin Connect the Electrode Pads provided to the Electrode Wires No metal should be visible See Figure 8 Remove the Electrode Pads from the film by grasping the edge of the Electrode and peeling it off See Figure 9 Figure 8 Figure 9 27 ...

Page 30: ...of the icons for 2 seconds before transitioning to the start screen See Figures 11 12 Place the Electrode Pads on the precise skin location by applying the center of the Electrode first and smoothing down the edges The complete surface of the Electrodes should be in contact with the skin See Figure 10 Figure 11 Figure 12 Figure 10 On Off 28 ...

Page 31: ... the Program Key P to select the appropriate treatment program See Figures 13 14 Displayed on the screen will be P followed by the number corresponding with the Program i e P1 See Figure 15 To view the 14 preset Programs go to page 42 for more information Figure 15 Figure 13 Figure 14 Channel Key Program Key 29 ...

Page 32: ...y a factor of one for that channel Pressing button during treatment decreases the intensity level by a factor of one See Figure Figure 18 Intensity Bar Increasing Figure 17 Intensity Bar Decreasing Figure 16 Intensity Key The user can feel the stimulation when he or she increases or decreases the intensity level The Intensity Bar will increase and decrease corresponding to the contraction and rela...

Page 33: ...d the Lock Key for 2 seconds to avoid unwanted changes to the intensity level To disable the Lock function simply press and hold the Lock Key again for 2 seconds and the key symbol will disappear from the display See Figure 19 Note To pause the treatment session press and release the Pause Trigger Key T The pause icon will appear and the device will interrupt the program To resume the session pres...

Page 34: ...ld for 3 seconds to activate the Trigger Mode See Figure 22 An arrow symbol will appear below the corresponding Channel See Figure 23 When pressing the T key the stimulator enters a contraction cycle for as long as the key is pressed When the key is released the stimulator is off During the length of the Trigger Mode session the corresponding Channel will continue to flash and the arrow symbol wil...

Page 35: ...proximately 5 seconds and the arrow symbol will turn off Caution In Trigger Mode where stimulation is held constant for several continuous seconds muscle fatigue could occur Custom Program Program 15 To customize the parameters press the Program Key P and hold for 3 seconds See Figure 25 The icons of F W S R T will flash simultaneously See Figure 26 Figure 24 Intensity Key Figure 25 Program Key 33...

Page 36: ...Keys to adjust the Frequency See Figures 27 28 Figure 27 Figure 28 Intensity Key Icon Range F Frequency range 1 125Hz below 5Hz with steps of 1Hz above 5Hz with steps of 5Hz W Pulse Width range 100 350μs 10 with steps of 50μs S Contraction time range 1 10s with steps of 1s R Relaxation time range 1 10s with steps of 1s T Treatment time range 5 60 minutes with intervals of 5 minutes 34 ...

Page 37: ... set the other parameters repeat the above steps Once finished Press the Pause Trigger Key to exit the parameters setting mode See Figure 30 Note 1 The unit will automatically save the latest entries To access the custom program for future use select Program 15 Note 2 To start the custom program follow the steps under Select and Start a Program on page 29 Figure 30 Pause Trigger Key Figure 29 Prog...

Page 38: ...ation to an impaired sensory system can improve neuroplasticity motor recovery and function Clients suffering from impaired function weakness and spasticity can benefit from the much needed stimulation SaeboStim Pro offers a Sensory Electrical Stimulation program Program 14 provides SES to the arm and hand using a specialized Electro Mesh garment technology sold separately The Electro Mesh garment...

Page 39: ...should check and reconnect the Electrode Pads or ensure good skin contact is present The intensity level will be reset to zero requiring the user to press the intensity increase button to return to the desired level Figure 32 Treatment Completion When the treatment is complete the stimulation will stop automatically At this stage the unit should be turned off and all of the Electrode Pads can safe...

Page 40: ... hot water to wash the Electrode Pads Use plain water to clean the Electrode Pads and air dry Please do not bend the Electrode Pads This product s packaging and product appearance must be checked before use it is forbidden to use if there is damage dirt or deformation Electrodes cannot be placed near the heart Electrodes cannot be placed near wounds or scars If there is any pain during stimulation...

Page 41: ...y scrub with your fingers for a few seconds After drying it can temporarily restore its viscosity If the water is too much the viscosity will decrease Please do not use tissue or cloth to wipe the gel surface Please do not use fingernail or brush to scrape the gel surface Replace Batteries The battery icon will appear at all times during operation in the top center of the display When the stimulat...

Page 42: ... Power adapter input AC 100 240V 50 60Hz 0 3A output DC 5V 1 2A Protection against electric shock Class II Safety class BF type Protection Grade IP22 Shutdown current 0 1mA Operating current 1200mA Environmental Specifications Working Condition Temperature 5o C 40o C Relative Humidity 80 Atmospheric pressure 86Kpa 106Kpa Storage and Transport Condition Temperature 20o C 55o C Relative Humidity 93 ...

Page 43: ...SaeboStim Pro 41 ...

Page 44: ...p sec Ramp Down sec Trigger Treat Time mins 1 Upper Extremity Short Contraction 35 250 9 5 2 2 Yes 30 2 Upper Extremity Long Contraction 35 250 14 10 2 2 Yes 30 3 Note 1 Upper Extremity Alternating 35 250 9 5 2 2 No 30 4 Upper Extremity Advanced 60 250 14 10 2 2 Yes 30 5 Shoulder Subluxation 35 300 12 8 2 2 No 60 6 Lower Extremity Short Contraction 35 350 9 5 2 2 Yes 30 42 ...

Page 45: ...s 7 Lower Extremity Long Contraction 35 350 14 10 2 2 Yes 30 8 Note 2 Lower Extremity Alternating 35 350 9 5 2 2 No 30 9 Lower Extremity Advanced 60 350 14 10 2 2 Yes 30 10 Edema 5 200 3 2 0 0 No 30 11 Pain 1 4 200 No 45 12 Pain 2 125 175 No 45 13 Note 3 Pain 3 Alternating 125 4 150 250 No 45 14 Note 4 SES 50 100 No 30 15 Custom 1 125 100 350 1 10 1 10 0 0 No 5 60 43 ...

Page 46: ...d Channel B is off Then Channel B stimulates for 9 seconds including Ramp up down and Channel A is off Repeat Note 2 Program 8 Channel A stimulates for 9 seconds including Ramp up down and Channel B is off Then Channel B stimulates for 9 seconds including Ramp up down and Channel A is off Repeat See below illustration 44 ...

Page 47: ...rogram Information Continued Note 3 Program 13 Constant stimulation for 45 minutes In 12 seconds cycle it remains at 125Hz 150μs for the first 6 seconds and 4Hz 250μs for the second 6 seconds See below illustration 45 ...

Page 48: ...ove neuroplasticity motor recovery and function Clients suffering from impaired function weakness and spasticity can benefit from the much needed stimulation Program 14 provides SES to the arm and hand using a specialized Electro Mesh garment technology sold separately The Electro Mesh garments consist of an elbow sleeve arm stimulation and glove hand stimulation For optimum effectiveness conducti...

Page 49: ...ds The battery is low Replace the battery Stimulation received irregularly only at a high intensity or not at all Faulty electrode wire Replace electrode wire Stimulator stops stimulation and icon display on the screen electrode loose Check the connection between the stimulator and electrode wire Check the connection between the electrode wire and the electrode pads Check the connection between th...

Page 50: ...one year warranty starting at the date of purchase Saebo will not provide free repair for the malfunctions caused by the following behaviors Disassemble or modify the product without authorization Accidentally drop the product during use or transportation Lack of reasonable maintenance Operate not according to the instructions Repaired by unauthorized repair store 48 ...

Page 51: ...trict Shenzhen China Post Code 518118 Tel 86 755 29888818 Fax 86 755 28312625 Hotline 400 830 0991 E mail xft xft cn Website http www xft china com Authorized Distributor Saebo Inc 2459 Wilkinson Blvd Suite 120 B Charlotte NC 28208 Phone 888 284 5433 Fax 855 414 0037 Website https www saebo com US Agent Yang Lingyun 605 Sherwood Forest Place Cary North Carolina 27519 Phone 919 475 1044 49 ...

Page 52: ...www saebo com Saebo rev 1 20 ...

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