Richmar Intensity Select Combo Tens EMS IF and Microcurrent Electrotherapy Instruction Manual

INTENSITY™ Select Combo II
INSTRUCTION MANUAL

Intensity Select Combo Tens EMS IF and Microcurrent Electrotherapy

This manual is valid for the Select Combo II
This instruction manual is published by Compass Health Brands Corp.
Compass Health Brands Corp. reserves the right to improve and amend it at any time without prior notice. Amendments may however be published in new editions of this manual.
All Rights Reserved Revision B© 2023
United States Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner
Conformity to safety standards
Compass Health Brands Corp. declares that the device complies with following normative documents:
IEC60601-1, IEC60601-1-2, IEC 60601-2-10,
IEC62366, IEC60601-1-11, ISO10993-5, ISO10993-10,
ISO10993-1, ISO7010

InTENSity Select Combo II Compass Health Brands

INTRODUCTION

1.1 General
The InTENSity Select Combo II stimulator is a portable electrotherapy device featuring four therapeutic modes: Transcutaneous Electrical Nerve Stimulator (TENS), Neuromuscular Electrical Stimulation
(NMES), Interferential (IF) and Russian which are used for pain relief.
The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of device are controlled by the buttons on the front panel. The intensity level is adjustable according to the needs of patients.
1.2 Medical Background
Explanation of pain
Pain is an unpleasant sensation that can serve a useful purpose by alerting us to a possible injury or disease. When the body is functioning normally, pain serves as a warning system that something is not right.
Without pain a person would not know when to avoid danger or seek medical help. Pain becomes a problem when it continues after treatment has started or long after an injury is healed.
How TENS work?
There is nothing “magic” about Transcutaneous Electrical Nerve Stimulation (TENS). TENS is intended to help relieve pain. The TENS unit sends comfortable impulses through the skin to stimulate the nerve (or nerves) in the treatment area. In many cases, this stimulation will greatly reduce or eliminate the pain sensation the patient feels. Pain relief varies by individual patients, mode selected for therapy, and the type of pain. In many patients, the reduction or elimination of pain lasts longer than the actual period of stimulation (sometimes as much as three to four occurs. You may discuss this with your physician or therapist.
How NMES works
Neuromuscular Electrical Stimulation (NMES) is an internationally accepted and proven way of treating muscular injuries. It works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise passively. This device is low frequency and in conjunction with the square wave pattern allows the stimulation to work directly on the muscle groups. This is being widely used in hospitals and sports clinics for the treatment of muscular injuries and for the re-education of paralyzed muscles, to prevent atrophy in affected muscles and improving muscle tone and blood circulation.
The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. Normal muscular activity is controlled by the central and peripheral nervous systems, which transmit electrical signals to the muscles. NMES works similarly but uses an external source (the stimulator) with electrodes attached to the skin for transmitting electrical pulses into the body. The pulses stimulate the nerves to send signals to with normal muscular activity.
EXPLANATION OF IF
treatment modality. Interferential stimulation is characterized by two alternating-current sine waves or square waves of differing frequencies that “work” together to produce an interferential current that is also known as a beat pulse or alternating modulation frequency. One of the two currents is usually held at 5,000Hz,and the other can be held constant or varied over a range of 5,001 to 5150Hz. Because of the frequency, the interferential wave meets low impedance when crossing the skin to enter deep into soft tissues. The interferential currents at the spinal cord level. This deep tissue penetration stimulates reduction. It utilizes the low electric-current to stimulate muscle nerves to achieve the symptomatic relief of chronic intractable pain, post-traumatic pain, and post-surgical pain.
EXPLANATION OF RUSSIAN
Russian stimulation uses medium frequencies to provide electrical stimulation to muscle groups and is used to reduce muscle spasms form of electro- stimulation with a Symmetrical Biphasic Square waveform produced by dividing a 2,500Hz carrier frequency into 20 – 80Hz packets. This method was claimed by its author (Kots) discomfort to the patient.
1.3 Indication for use
Select Combo II Stimulator may be used for the following conditions:

1. Symptomatic relief of chronic intractable pain.
2. Post traumatic pain.
3. Post surgical pain.
4. Relaxation of muscle spasm.
5. local
6. Prevention or retardation of disuse atrophy.
7. Muscle re-education.
8. Maintaining or increasing range of motion.
9. Immediate post-surgical stimulation of muscles to prevent venous thrombosis.

IMPORTANT SAFETY PRECAUTIONS AND WARNINGS

It is important that you read all the warning and precautions included in this manual because they are intended to keep you safe, prevent injury and avoid a situation that could result in damage to the device.

SAFETY SYMBOLS USED IN THIS MANUAL

WARNING| Indicates a potentially hazardous situation which, if not avoided, could result in serious injury and equipment damage.
---|---
CAUTION| Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the device or other property.

Contraindications
This stimulator must not be used in combination with the following medical devices:

• This device should not be used for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed.

• This device should not be used when cancerous lesions are present in the treatment area.
  skin eruptions (e.g. phlebitis, thrombophlebitis, varicose veins, etc.).

• Electrode placements must not be applied to sites that might cause transcerebrally (through the head).

• Do not use this device if the patient has a demand-type cardiac pacemaker, device. Such use could cause electric shock, burns, electrical interference, or death.

• This device should not be used over poorly enervated areas.

• Epilepsy

• Serious arterial circulatory problems in the lower limbs

• Abdominal or inguinal hernia

• Do not use this device if have heart disease without consulting your physician.

WARNING
DO NOT USE THIS DEVICE UNDER THESE CONDITIONS

• Consult with your physician before using this device, because the device may cause lethal rhythm disturbances in certain susceptible individuals.
  heart or lung or respirator.

• 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.

• Over areas of skin that lack normal sensation.

• On the opposite sides of your head since the effects of stimulation of the brain are unknown.

• Simultaneous connection of a patient to a high frequency surgical device may result in burns at the site of the electrodes and cause possible damage to the device.

• Operation in close proximity to a shortwave or microwave therapy device may produce instability in the device output.

DO NOT USE ON THESE INDIVIDUALS

• Pregnant women, because the safety of electrical stimulation during pregnancy has not been established.
• Children or infants, because the device has not been evaluated for pediatric use.
• Persons incapable of expressing their thoughts or intentions.

DO NOT USE THIS DEVICE DURING THESE ACTIVITIES

• When in the bath or shower
• While sleeping
  While driving, operating machinery, or during any activity in which electrical stimulation can put you at risk for injury.

PAIN MANAGEMENT WARNINGS

• If you have had medical or physical treatment for your pain, consult with your physician before using this device.
• If your pain does not improve, becomes seriously chronic or severe, or continues for more than five days, stop using the device and consult with your physician.
• The mere existence of pain functions as a very important warning telling us that something is wrong. Therefore, if you suffer from any serious illness, consult your physician in order to confirm that it is advisable for you to use this TENS Stimulator.

WARNINGS AND PRECAUTIONS REGARDING THE PADS

• Apply pads to normal, healthy, dry, clean skin (of adult patients) because it may otherwise dispute the healing process.
• If you experience any skin irritation or redness after a session, do not continue stimulation in that area of the skin.

NEVER APPLY THE PADS TO:

• The head or any area of the face.
• Any area of the throat because this could cause severe mused spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
• Both sides of the thorax simultaneously (iateral or front and @ back), or across your chest because the introduction of electrical current may cause rhythm disturbances which could be lethal.

CAUTION
WARNINGS AND PRECAUTIONS REGARDING THE PADS

• United States Federal Law restricts this device to sale by or on the order of a physician o licensed practitioner
• Do not bend or fold because the pad may not function propery. Place the pads onto the plastic film and then store into the sealed package when not in use.
• Do not apply cintment or any solvent to the pads or to your skin because it will disrupt the pads from functioning properly.
• The pads are already pre-gelled and will adhere to your skin.
• To avoid damage to the adhesive surface of the pads, put the pads only on the skin or on the plastic film provided.
• Place the pads at least 1 inch apart on your skin. The pads should never touch each other.
• Make sure the components are connected well and the pads are fixed on the part of the body you wish to treat or the therapy may not be effective.

DO NOT USE YOUR PADS THIS WAY

• Pads should not touch each other when placed onto your skin.
• Do not place on your spine or backbone.
• Pad should not touch any metal object, such as a beft buckle or necklace.
• Pads should not be placed simultaneously on the soles of both feet.
• Pads should not be placed simultaneously on the calves of both legs.
• Do not share pads with another person. This may cause a skin irritation or infection. Pads are intended for use by one person.
• Do not place or relocate the pads while the device is on.
• Always tur the power off before removing or changing the pad location.
• Do not leave pads attached to the skin after treatment.

CAUTION WHILE USING THE STIMULATOR

• If the stimulator is not functioning properly or you feel discomfort, immediately stop using the device.

• Do not use for any other purpose except for what it is intended for.

• Do not insert the electrode plug into any place other than the jack on the main unit.

• Do not mix Alkaline and Manganese batteries as this will shorten the battery life.

• Do not pull on the electrode cord during treatment.

• Do not use the device while wearing electronic devices such as watches as this may damage the device.

• Do not use near a cell phone as this may cause the stimulator to malfunction.

• Do not bend or pull the end of the cord.

• When pulling out the cord from the device, hold the plug and pull.

• Replace the cord when broken or damaged.

• Do ot throw the batteries into a fire. The batteries may explode.

• Dispose of the device, batteries, and components according to applicable legal regulations. Unlawful disposal may cause environmental pollution.

• The size, shape and type of pads may affect the safety and effectiveness of electrical stimulation.

• The electrical performance characteristics of pads may affect the safety and effectiveness of electrical stimulation.

• Using pads that are too small or incorrectly applied, could result in discomfort or skin burns.
  Itis recommended not to exceed a current density of 2 mA/cm2,otherwise skin irritations or bums can occur. We recommend the below:

• Please use specic size electrodes provided by manufacturer to avoid skin irritations or burns.

• For smaller electrodes, the maximum current setting of the waveform should be appropriately reduced.

• Please place the electrodes carefully, ensure that the entire surface of the electrode has good contact with the skin and does not lift on any of the comers.

• Please space the electrodes at least 2″ but not more than 6″ apart, per channel. If using Interferential, make sure each each electrode from each channel are criss-crossed (placed diagonally across) from each other.

GENERAL PRECAUTIONS

• The long-term effects of electrical stimulation are unknown.
• Apply stimulation to only normal, intact, clean, dry, and healthy skin.
• TENS is not effective in treating the original source or cause of the pain, including headache.
• TENS is not a subsitute for pain medications and other pain management therapies.
• TENS devices do not cure disease or injuries.
• TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a protective mechanism.
• Effectiveness is highly dependent upon patient selection by a pracitioner qualified in the management of pain patients.
• 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.
• Use caution i 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 the menstruating or pregnant uterus.
• Use caution if stimulation is applied over areas of skin that lack normal sensation.
• Keep unit away from young children. The unit contains small pieces that may be swallowed. The electrode cord can cause strangulation. Immediately contact your physician should any of these things occur.
• Use this device only with the leads, electrodes, and accessories recommended by the manufacturer.
• Keep unit out of the reach of young children.

POSSIBLE ADVERSE REACTIONS

• Do not use to treat one region for extended periods of time (more than 30 minutes a session, up to 2 times/day) or muscles in that region may become exhausted and sore.
• You may experience skin irrtation and burns beneath the stimulation electrodes applied to your skin.
• You should stop using the device and consuit with your physician if you experience adverse reactions from the device.
  Note: Always use electrodes that are legally marked and sold in the United States under 510K guidelines.

PACKAGE CONTENTS

3.1 Front and Rear Panel

1. LCD Display: Operating state of the device
2. Body Part Buttons: Select body part or treatment program
3. Channel 1 Intensity Buttons: Increase or decrease the output intensity of channel 1.
4. Setbutton: Press this button to enter the setting status
5. Power Button: Press once to turn on. Press and hold for 3 seconds to tum off.
6. Channel 2 Intensity Buttons: Increase or decrease the output intensity of channel 2.
7. Pause/Mode Button; Press this button to change treatment modes (TENS, NMES, IF & RUSS). Press button again to pause active treatment status
8. LED: Charging indicator light.
9. Output Sockets: Lead wire output sockets
10. Battery compartment cover.
11. Belt Clip.
12. USB charging port.

3.2 LCD Display

1. Displays waveform mode.
2. Displays home screen
3. Displays set mode
4. Displays output state: start, pause, lock
5. Hour Indicator for compliance meter
6. Cycle Time
7. Displays output intensity of channel 1, pulse width and pulse rate Beat L
8. Displays therapeutic body part: hand, foot, shoulder, arm, leg and back
9. Displays therapeutic mode: TENS, NMES, IF & RUSS
10. Low-battery indicator
11. Load indicator
12. Indicates compliance meter mode
13. Displays the treatment time
14. Display output intensity of channel 2, Beat H

SPECIFICATIONS

4.1 Technical Information

(optional)
Operating Conditions| 5°C to 40°C (41°F to 104°F) with a relative humidity of 30% – 75%,atmospheric pressure from 700 to 1,060 hPa
Storage and Transport Conditions| -10°C to 55°C (14°F to 131°F) with a relative humidity of 10%-90%,atmospheric pressure from 700 to 1,060 Hpa
Dimensions| 11.7 × 6 × 2.1 cm (LWH)
Weight| 3.5 oz. (Without battery)
Electrode Detection Function| The amplitude level will be reset to 0mA when the amplitude level is 10mA or greater and an open circuit at either channel is detected.

Technical Specifications

load),1mA/ step
Pulse Width (Adjustable)| TENS:| 50~400uS
NMES:| 200~400uS
IF:| 100/200/400uS
RUSSIAN:| 400uS
Pulse Rate| From 1 to 150 Hz
Treatment Time| TENS/EMS/IF: 5~90min RUSS: 5~60min

4.2 Program Parameters
TENS

Body Part| Program| Treatment Time| Pulse Rate| Pulse Width|

Cycle Time

---|---|---|---|---|---
| P1| 20 Min.| 80 – 100Hz| 100 – 120µs| 10 Sec
P2| 20 Min.| 4Hz| 150 – 200µs| 20 Sec
| P1| 20 Min.| 80 – 100Hz| 100µs| 10 Sec
P2| 20 Min.| 10Hz| 220 – 260µs| 20 Sec
| P1| 20 Min.| 100Hz| 100µs| Fixed
P2| 20 Min.| 1 – 10Hz| 200µs| 20 Sec
| | 20 Min.| 80 – 100Hz| 100µs| 10 Sec
P2| 20 Min.| 4Hz| 200 – 260µs| 20 Sec
| | 20 Min.| 120Hz| 100 – 120µs| 10 Sec
P2| 20 Min.| 1 – 10Hz| 150 – 200µs| 20 Sec
| P1| 20 Min.| 80 – 120Hz| 100 – 120µs| 10 Sec
P2| 20 Min.| 1 – 10Hz| 200µs| 20 Sec
Body Part| Program| Treatment Time| Pulse Rate| Pulse Width
---|---|---|---|---
All Therapeutic Parts| U1| Adjustable 5 – 90 mins| Adjustable 1 – 150 Hz| Adjustable 50 – 400µs

NMES

Body Part| Program| Treatment Time| Pulse Rate| Pulse Width| Contract Time| Relax Time|

Ramp Up/Down

---|---|---|---|---|---|---|---
| P1| 20 Min.| 40Hz| 300µs| 12 Sec| 20 Sec| 2 Sec
P2| 20 Min.| 50Hz| 300µs| 12 Sec| 30 Sec| 2 Sec
| P1| 20 Min.| 45Hz| 300µs| 12 Sec| 20 Sec| 2 Sec
P2| 20 Min.| 55Hz| 300µs| 12 Sec| 35 Sec| 2 Sec
| P1| 20 Min.| 10Hz| 300µs| 12 Sec| 20 Sec| 2 Sec
P2| 20 Min.| 15Hz| 300µs| 12 Sec| 30 Sec| 2 Sec
| P1| 20 Min.| 60Hz| 300µs| 12 Sec| 20 Sec| 2 Sec
P2| 20 Min.| 70Hz| 300µs| 12 Sec| 30 Sec| 2 Sec
| P1| 20 Min.| 20Hz| 300µs| 15 Sec| 30 Sec| 2 Sec
P2| 20 Min.| 25Hz| 300µs| 12 Sec| 50 Sec| 2 Sec
| P1| 20 Min.| 30Hz| 300µs| 12 Sec| 20 Sec| 2 Sec
P2| 20 Min.| 35Hz| 300µs| 12 Sec| 30 Sec| 2 Sec
All Body Parts| U1| Min: 5 – 90,
Step: 5min Default: 20Min| 1 – 100Hz
Step: 1Hz Default: 40Hz| 200 – 400µs
Step: 5 Default: 300uS| 5 – 30s
Step:1s Default: 12s| 5 – 60s
Step: 1s Default: 20s| 1 – 9s
Step: 1s Default: 2s
Body Part| Program| Treatment Time| Carrier F| | Pulse Width| Beat Low| Beat High|

Cycle Time

---|---|---|---|---|---|---|---|---
| P1| 20 Min.| 10,000Hz| 100µs| 1Hz| 100Hz| 10 Sec
P2| 20 Min.| 5,000Hz| 200µs| 1Hz| 100Hz| 20 Sec

| P1| 20 Min.| 10,000Hz| 100µs| 50Hz| 150Hz| 10 Sec
P2| 20 Min.| 5,000Hz| 200µs| 50Hz| 150Hz| 20 Sec
| P1| 20 Min.| 10,000Hz| 100µs| 1Hz| 20Hz| 10 Sec
P2| 20 Min.| 5,000Hz| 200µs| 1Hz| 20Hz| 20 Sec
| P1| 20 Min.| 10,000Hz| 100µs| 1Hz| 50Hz| 10 Sec
P2| 20 Min.| 5,000Hz| 200µs| 1Hz| 50Hz| 20 Sec
| P1| 20 Min.| 10,000Hz| 100µs| 60Hz| 120Hz| 10 Sec
P2| 20 Min.| 5,000Hz| 200µs| 60Hz| 120Hz| 20 Sec

| P1| 20 Min.| 10,000Hz| 100µs| 1Hz| 30Hz| 10 Sec
P2| 20 Min.| 5,000Hz| 200µs| 1Hz| 30Hz| 20 Sec
All Body Parts| U1| Min: 5 – 90, Step is 5min Default: 20Min| N/A| 100µs, 200µs, 400µs change in a cycle, default: 100uS| 1 – 149Hz
tep is 1, default: 1Hz| 81 – 200Hz
Step is 1, Default: 81Hz| 1 – 20s Step is 1, Default: 20s

RUSSIAN (RUSS) RUSSIAN (RUSS)

Body Part| Program| Treatment Time| Carrier F| Pulse Width| | Burst Time| Burst F| Contraction| Relaxation|

Ramp Up/Down

---|---|---|---|---|---|---|---|---|---|---
| P1| 15 Min.| 2,500Hz| 400µs| Burst/interval 10ms each Duty cycle 50%| 40Hz| 12s| 20s| 2s
P2|

15 Min.

|

2,500Hz

|

400µs

| Burst/interval 10ms each Duty cycle 50%| 50Hz| 12s| 30s| 2s
|

P1

|

15 Min.

|

2,500Hz

|

400µs

| Burst/interval 10ms each Duty cycle 50%|

45Hz

|

12s

|

20s

|

2s

P2| 15 Min.| 2,500Hz| 400µs| Burst/interval 10ms each Duty cycle 50%| 55Hz| 12s| 30s| 2s
| P1| 15 Min.| 2,500Hz| 400µs| Burst/interval 10ms each Duty cycle 50%| 10Hz| 12s| 20s| 2s
P2| 15 Min.| 2,500Hz| 400µs| Burst/interval 10ms each Duty cycle 50%| 15Hz| 12s| 35s| 2s
| P1| 15 Min.| 2,500Hz| 400µs| Burst/interval 10ms each Duty cycle 50%| 60Hz| 12s| 20s| 2s
P2| 15 Min.| 2,500Hz| 400µs| Burst/interval 10ms each Duty cycle 50%| 70Hz| 12s| 30s| 2s
| P1| 15 Min.| 2,500Hz| 400µs| Burst/interval 10ms each Duty cycle 50%| 20Hz| 12s| 20s| 2s
P2| 15 Min.| 2,500Hz| 400µs| Burst/interval 10ms each Duty cycle 50%| 25Hz| 12s| 30s| 2s
| P1| 15 Min.| 2,500Hz| 400µs| Burst/interval 10ms each Duty cycle 50%| 30Hz| 12s| 30s| 2s
P2| 15 Min.| 2,500Hz| 400µs| Burst/interval 10ms each Duty cycle 50%| 35Hz| 12s| 50s| 2s
All Body Parts| U1| Min: 5 ~ 60, Step is 5min Default: 20Min| N/A| N/A| N/A| N/A| 5 ~ 30s
Step is 1, Default: 12s| 5 ~ 60s Step is 1, Default: 20s| 1 ~ 9s Step is 1, Default: 2s

4.3 Waveform Information
TENS

NMES

INSTRUCTIONS FOR USE

5.1 Battery
Installation of Battery
Push down on the belt clip to release it. Remove the battery cover and insert the battery, as shown on the diagram. Replace the battery cover and belt clip. For battery charging instructions, please see page 41.

Disposal of Battery Depleted batteries do not belong in the household waste.
Dispose of the batteries according to the your federal, state and local regulations. As a consumer, you are obligated by law to retum depleted batteries .
CAUTION

1. Keep the battery and the product out of the range of children.
2. Battery may not be dismantled, thrown into fire or short-circuited.
3. Protect battery from excess heat, Take the battery out of the product if the product is not used for a long period of time.
4. Aways replace with the same type of battery.

5.2 Connecting Electrodes
Take the pads out of the sealed package; insert the pin of the lead wire into the electrodes pigtail. Make sure there is no bare metal exposed.

CAUTION
‘Always use electrodes with CE mark, or which are legally marketed in the US under 510(K) procedure.
5.3 Connecting Lead Wires

1. Before proceeding to this step, be sure the device is completely turned OFF.
2. Insert the lead wires into the output sockets located on the top of the device.
3. Holding the insulated portion of the connector, push the plug end of the wire into one of the sockets (see drawing); one or two sets of wires may be used.
4. This device has two output receptacles controlled by Channel 1 and Channel 2 at the top of the unit. You may choose to use one channel with one pair of lead wires or both channels with two pairs of lead wires. Using both channels gives the user the advantage of stimulat- ing two different areas at the same time.

Note: If you use only one Channel, only plug in 1 lead wire at the top of the unit
5.4 Turn on The Device
Press the [ ] button to turn on the device.
CAUTION
Before using the device for the first time, you are strongly advised to take careful note of the contraindications and safety measures detailed at the beginning of this manual (Safety information), as this powerful equipment is neither toy nor a gadget!
5.5 Setting a New Program
There are 6 therapeutic body part buttons available — neck, shoulder, hand, low back, knee and foot. Each therapeutic part has 3 programs — P1, P2 and U1 for a total of 72 programs.

1. Press [ M/ ] button to select the treatment mode (TENS, NMES, IF, RUSS). FAEN
2. Select a body part on the device and press it.
3. The body part will display on the LCD screen.
4. Press the same button again to select one of the 3 programs (suchas P1, P2 or U1).

Manual TENS Program — U1
A. Select Body Part
Press the “M/II” button to choose TENS mode. Then select the body part which you want to treat. Press the body part button until the LCD displays program “U1”

B. Set Treatment Time
Press [ $ ] button to enter treatment time and the “min.” will flash.
Then press [ +] or [ =] button to adjust the treatment time.

C. Set Pulse Rate
Press [ $ ] button to enter the pulse rate and the “Hz” will flash.
Press [ +] or [ =] button to adjust pulse rate.

D. Set Pulse Width
Press [ $] button to enter the pulse width and the “us” will flash. Then press [ +] or [ =] button to adjust the pulse width.

Set Preset TENS Programs — P1 and P2
A. Select Body Part
Press the “M/II” button to choose TENS mode. Then select the body part which you want to treat. Press the body part button until the LCD displays program “P1” or “P2″

B. Set Treatment Time
Press [ §] button to enter the treatment time and the “Min” will flash.
Press [ +] or [ =] button to adjust treatment time. After you finished settings, press the [ S ] or [ ® button to confirm, the device will go back to the home screen.

C. Start Treatment
Press [CH14] or [CH24] to increase the output intensity of channel 1 and/or channel 2. Press [CH1-] or [CH2-] to decrease the output intensity of channel 1 and/or channel 2.
Manual NMES Program — U1
A. Select Body Part
Select the body part which you want to treat. Then press the body part button until the LCD displays program “U1” like the following:

B. Set Treatment Time
Press [ $ ] button to enter treatment time and the “min.” will flash.
Then press [ +] or [ =] button to adjust the treatment time.

C. Set Pulse Rate
Press [ S ] button to enter the pulse rate and the “Hz” will flash.
Press [ +] or [ =] button to adjust pulse rate.

D. Set Pulse Width
Press [ §] button to enter the pulse width and the “us” will flash. Then press [ +] or [ -] button to adjust the pulse width.

E. Set Ramp Up Time
Press [ $] button to set the ramp up and down time and the “sec.” will flash and you will see the below image circled in red on the screen.
Then press [ +] or [ =] button to adjust the treatment time.

F. Set Contraction Time
Press [ §] button to set the contraction time and the “sec.” will flash along with the symbol circled in red below. Then press [ +] or [ = | button to adjust the time.

G. Set Relaxation Time
Press [ §] button again to set the relaxation time and the “sec.” will flash along with the picture circled in red below. Then press [ +] or [ =] button to adjust the time.

After you finished settings, press [ (] button to confirm, the device will back to standby status.
H. Start Treatment
Press [CH1+] or [CH24+] to increase the output intensity of channel 1 and/or channel 2. Press [CH1-] or [CH2-] to decrease the output intensity of channel 1 and/or channel 2.
Set Preset NMES Programs — P1 and P2
A. Select Body Part
Press the “M/II” button to choose NMES mode. Then select the body part which you want to treat. Press the body part button until the LCD displays program “P1” or “P2”

B. Set Treatment Time
Press [ S ] button to enter the treatment time and the “Min” will flash.
Press [ +] or [ = ] button to adjust treatment time. After you finished settings, press the [ S ] or [ ¢) button to confirm, the device will go back to the home screen.
C. Start Treatment
Press [CH1 ] or [CH24] to increase the output intensity of channel 1 and/or channel 2. Press [CH1-] or [CH2-] to decrease the output intensity of channel 1 and/or channel 2.
Manual IF (Interferential) Program — U1
A. Select Body Part
Select the body part which you want to treat. Then press the body part button until the LCD displays program “U1” like the following:

B. Set Treatment Time
Press [ §] button to enter treatment time and the “min.” will flash.
Then press [ +] or [ =] button to adjust the treatment time.

C. Set Pulse Width
Press [ §] button to enter the pulse width and the “us” will flash. Then press [ +] or [ =] button to adjust the pulse width.

D. Set Pulse Beat (Low & High)
Press [‘$ ] button to enter the pulse beat and the “Hz” will flash.
Press [ +] or [ ] button to adjust pulse beat.

E. Set Cycle Time
Press [ ] button to set the cycle time and the “sec.” will flash and you will see the below image circled in red on the screen.
Then press [ +] or [ =] button to adjust the treatment time.

After you have finished with the settings, press the [ & ] button to confirm, the device will go back to the home screen.
F. Start Treatment
Press [CH1+] or [CH24+] to increase the output intensity of channel 1 and/or channel 2. Press [CH1-] or [CH2-] to decrease the output intensity of channel 1 and/or channel 2.
Set Preset IF (Interferential) Program — P1 or P2
A. Select Body Part
Press the “M/II” button to choose IF mode. Then select the body part which you want to treat. Press the body part button unti the LCD displays program “P1” or “P2”

B. Set Treatment Time
Press [ $] button to enter the treatment time and the “Min” will flash.
Press [+] or [ -] button to adjust treatment time. After you finished setings, press the [ $ ] or [ & Jbutton to confirm, the device will go back to the home screen.

C. Start Treatment
Press [CH14] or [CH24] to increase the output intensity of channel 1 and/or channel 2. Press [CH1-] or [CH2-] to decrease the output intensity of channel 1 and/or channel 2.
Manual RUSS (Russian) Program — U1
A. Select Body Part
Select the body part which you want to treat. Then press the body part button until the LCD displays program “U1” like the following:

B. Set Treatment Time
Press [ $ ] button to enter treatment time and the “min.” will flash.
Then press [ +] or [ =] button to adjust the treatment time.

C. Set Ramp Up Time
Press [ $] button to set the ramp up and down time and the “sec.” will flash and you will see the below image circled in red on the screen.
Then press [ +] or [ =] button to adjus( the treatment time.

D. Set Contraction Time
Press [ §] button to set the contraction time and the “sec.” will flash along with the symbol circled in red below. Then press [ +] or [ = | button to adjust the time.

E. Set Relaxation Time
Press [ $] button again to set the relaxation time and the “sec.” will flash along with the picture circled in red below. Then press [ +] or [ =] button to adjust the time.

After you have finished with the settings, press the [ & ] button to confirm, the device will go back to the home screen.
F. Start Treatment
Press [CH1 ] or [CH24] to increase the output intensity of channel 1 and/or channel 2. Press [CH1 -] or [CH2-] to decrease the output intensity of channel 1 and/or channel 2.
Set Preset RUSS Programs — P1 and P2
A. Select Body Part
Press the “M/II” button to choose RUSS mode. Then select the body part which you want to treat. Press the body part button until the LCD displays program “P1” or “P2”

B. Set Treatment Time
Press [ $ ] button to enter the treatment time and the “Min” will flash.
Press [ +] or [ =] button to adjust treatment time. After you finished settings, press the [ S ] or [ ¢ Jbutton to confirm, the device will go back to the home screen.

C. Start Treatment
Press [CH1+] or [CH24+] to increase the output intensity of channel 1 and/or channel 2. Press [CH1-] or [CH2-] to decrease the output intensity of channel 1 and/or channel 2.
CAUTION

1. If the electrodes are not placed fimly on skin or the device has not connected with the electrodes or lead wires securely, and the output intensity level is equal to or greater than 10mA, the intensity will stop automatically.
2. If the stimulation levels become uncomfortable, reduce the intensity o a comfortable level. Contact your medical practitioner if the problems pesist.

D. Pause or Stop Treatment
If there is an immediate need to pause treatment, press the [ M/ | button and the “II” will display on the LCD. Press it again to continue treatment or press [ ()] button to stop treatment and the device will return to the Pome soreen. .
5.6 Turn OFF Device
Press and hold [ (] button until the device turns off.
CAUTION
If there is no operation in the panel for 3 minutes in the standby status, the device will shut off automatically and you will hear a beep sound.
5.7 Other Important Functions
Safety Lock Feature
The lock function automatically activates after there is no operation in the panel for 20 seconds while in treatment status. The indicator “e0” will display on the LCD .
This is a safety feature to prevent accidental changes to your settings and to prevent accidentally increasing the output intensity level. Press [CH1-] or [CH2-] button to unlock.

Low Battery Indicator
When the low power indicator “ ” displays on the LCD, stop the device and charge the battery.
Charging the Battery
NOTE: Battery comes pre-charged.
Proceed as follows to recharge the battery:

• This device cannot be used while charging.
• Make sure that the device has been switched off.
• Make sure that the device is no longer connected to the patient (the output cables and electrodes must be disconnected).
• Connect the USB cable to the charging port on the top of device.
• Connect the USB cable to the wall outlet or USB port.
• When the device is charging, the indicator light will be red.
• It could take up to 6 hours to reach a full charge.
• When charging is completed, the indicator light will be green.

After the battery has been recharged, disconnect the cable from the wall outlet or USB port and the device is ready to be used again.
The life of a rechargeable battery depends on the number of recharging/ rundown cycles it undergoes and how these cycles are performed.
The following suggestions will help prolong the life of the battery:

• Whenever the device is not used frequently, charge the battery once a month.
• For longer battery life, discharge the battery as much as possible during battery operation.

CAUTION

1. Please use the standard charger provided by the manufacturer or agent.
2. When you are using the device, never connect it to the charger. If you do, the device will turn off automatically.
3. When charging is complete, you are strongly advised to disconnect the charger

5.8 Patient Compliance Meter
You can store 90 sets of treatment records and a total treatment time of up to 100 hours on this device.
A. Check and Delete Individual Records
In standby, press [ M/II ] button and hold for 3 seconds to enter the compliance meter records. The LCD will show the number of records and treatment time (as shown in the below picture). Press [ + ] or [ − ] buttons to check each record. To delete a record, press [ S ] button and hold for 3 seconds.

B. Check and Delete Accumulative Records
Individual records menu, press [ II ] button to switch to accumulative records menu. Press [ S ] button holding for 3 seconds and all of records will be deleted followed by a beeping sound.

CAUTION
The records will be permanently deleted and can be not restored if you follow the delete records method mentioned above.

CLEANING AND STORAGE

6.1 Cleaning the Unit

1. Turn unit off and disconnect the lead wires from the unit.
2. Clean the device after use with a soft, slightly moistened cloth   and wipe gently.
   • Do not use chemicals (like thinner, benzene).
   • Do not let water get into the internal area.

Note:

 This device and accessories (including the electrodes) do not   require sterilization.

6.2 Cleaning the Electrode Pads

1. Turn the power off and remove the lead wires from the electrodes.
2. Wash the electrodes when the adhesive surface becomes dirty and/or   the electrodes are difficult to attach.
   •  To “wash” the pads, place a small drop of water on your clean   fingertip and rub the water across the entire gel part. Place the  adhesive part face up and let it air dry until the water is absorbed and has been reconstituted. Do not wipe with a tissue paper or cloth. If the electrode still does not stick properly, replace them  with new electrodes.

CAUTION

1. The life of electrodes may vary by the frequency of washing, skin condition, and storage state.
2. If the electrodes no longer stick to your skin or the electrodes are broken, you should replace new electrodes.
3. Before applying the self-adhesive electrodes, it is recommended to wash and degrease the skin, and then dry it.
4. Do not turn on the device when the electrodes are not positioned on the body.
5. Never remove the self-adhesive electrodes from the skin while the device is still turned on.
6. If replacement electrodes are necessary, use only electrodes that are the same size (2″ x 2″) as the electrodes provided with the Select Combo II.
7. Use of electrodes that are larger may reduce the effect of the stimulation. Use of electrodes that are much smaller than the electrodes provided with the Select Combo II may increase the chance of skin irritation or electrode burns occurring under the electrodes.
8. Always use electrodes that have been cleared for marketing in the USA by the FDA.

6.3 Storing The Electrode Pads and Lead Wires

1. Turn the device off and remove the lead wires from the unit.
2. Remove the electrodes from your body and disconnect the lead wires from the electrodes.
3. Place the electrodes onto the plastic film and then store into the sealed package.
4. Wrap the lead wires and store into the sealed package.

6.4 Storing the Unit

1. Place the unit, electrodes, lead wires and manual back into the carrying case. Store the box in a cool, dry place, -10ºC ~ 55ºC; 10% ~ 90% relative humidity.
2. Do not keep in places that can be easily reached by children
3. When not in use for a long period, remove the battery before storage.

TROUBLESHOOTING

Problem| Possible Causes|

Possible Solution

---|---|---
The unit cannot power on| Are the batteries exhausted?| Charge or replace the batteries.
Are the batteries installed correctly?| Insert the batteries observing polarity.
Stimulation weak or cannot feel any stimulation| Electrodes dried out or contaminated| Replace with new electrodes
Electrodes are not securely attached to the skin.| Reconnect the electrodes
Lead wires Old/worn/damaged| Replace with new lead wires
Stimulation is uncomfortable| Intensity is too high| Decrease intensity.
Electrodes are too close together| Reposition the electrodes at least 1-1∕2 ” apart.
Electrode active area size is too small.| Replace electrodes with ones that have an active area no less than 25.0cm2 (5cm*5cm).
May not be operating the device according to the manual.| Please check the manual before use
Intermittent output| Lead wires| Verify connection is secure.
Turn down the intensity.
Rotate lead wires in socket 90°. If still intermittent, replace lead wire.
If still intermittent after replacing lead wire, a component may have failed. Call the repair department.
Stimulation is ineffective.| Improper electrode place- ment| Reposition the electrodes at least 1-1∕2” apart.
Unknown| Contact clinician.
The skin becomes red and/or you feel a stabbing pain| Using the electrodes on the same site every time.| Re-position the electrodes. If at any time you feel pain or discomfort stop use immediately.
The electrodes aren’t stuck onto the skin properly| Ensure the electrodes are stuck securely on the skin.
The electrodes are dirty.| Clean the electrodes according to description in this manual or replace with new electrodes.
The surface of the electrode was scratched.| Replace with a new electrode.
Output current stops during therapy| The electrodes come off the skin.| Turn off the device and place the electrodes again.
The lead wires are disconnected| Turn off the device and reconnect the lead wires.
The power of the batteries has been exhausted.| Charge or replace the batteries.
Li rechargeable battery pack doesn’t last or life is short| Brand new or stored batteries| This is normal operation. Please charge and use in device. You must do this 3 – 5 times before full capacity is reached.
Used Li rechargeable battery has reached end of life| Charge the battery. If this does not work, replace the battery.

DISPOSAL

Used fully discharged batteries must be disposed of in a specially labeled collection container, at toxic waste collection points or through an electrical retailer. You are under legal obligation to dispose of batteries correctly.
Please dispose of the device in accordance with the legal obligation .

GLOSSARY OF SYMBOLS

Electrical devices are recyclable material and should not be disposed of with household waste after their useful life! Help us to protect the environment and save resources and take this device to the appropriate collection points.
Please contact the organization which is responsible for waste disposal in your area if you have any questions.
Type BF Applied Part
Please refer to instruction manual because of the higher levels of output.

ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES

• Use of accessories, transducers and cables other than those specifie or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and resut in improper operation
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Portable RF communications equipment (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, including cables specified by jlnem by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Guidance and manufacturer’s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The customer or the user assures that it is used in such an environment.
Emissions| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR11| Class B| The device is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions lEC 61000-3-2| Class A
Voltage fluctuations / flicker emissions lEC 61000-3-3| Complies
Guidance and manufacturer’s declaration — electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Electrostatic discharge (ESD) IEC 61000-4-2| ±2, ±4, ±6 kV contact
±2, ±4,
±8 kV air| ±2, ±4,
±6 kV contact
±2, ±4, ±8
kV air| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical fast transient/burst IEC 61000-4-4| ±2 kV for power supply lines
±1 kV for input/output lines| ±2kV for power supply lines| Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5| ± 1 kV line(s) to line(s)
± 2 kV line(s) to earth| ±1 kV
differential mode| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| <5% UT
(>95% dip in UT)
for 0.5 cycle 40% UT
(60% dip in UT)
for 5 cycles 70% UT
(30% dip in UT)
for 25 cycles <5% UT
(>95% dip in UT)
for 5 sec| <5% UT (>95% dip in UT)for 0.5
cycle 40% UT
(60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5 sec| Mains power quality should be that of a typical commercial or hospital environment. If the user of the DEVICE requires continued operation during power mains interruptions, it is recommended that the DEVICE be powered from an uninterruptible power supply or a battery.
---|---|---|---
Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8| 3 A/m| 3 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospitalenvironment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration- Electromagnetic immunity

The device is intended for use in. the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Conducted RF lEC 61000-4-6 Radiated RF lEC 61000-4-3| 3 Vrms 150 kHz to 80 MHz 3 V/m80 MHz to 2.5 GHz| 3 Vrms 3 V/m| Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 150kHz to 80MHz
| | | , 80MHz to 800MHz , 800MHz to 2,5GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b
| | | Interference may occur in the vicinity of equipment marked with the following symbol:
---|---|---|---
NOTE I At 80 MHz ends 800 MHz. the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a   Field 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 which the DEVICE is used exceeds the applicable RF compliance level above, the DEVICE should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the DEVICE.
b  Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.c

Recommended separation distances between portable and mobile RF communications equipment and the device .
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 device as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter (W)| Separation distance according to frequency of transmitter(m)
---|---
150 KHz to 80 MHz| 80 MHz to 800 MHz| 800 MHz to 2 .5 GHz
0.01| 0.12| 0.12| 0.23
0.01| 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 metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

WARRANTY

Please contact your dealer or the device center in case of a claim under the warranty. If you have to send in the unit, enclose a copy of your receipt and state what the defect is. The following warranty terms apply:

1. The warranty period for device is one year from date of purchase.
   In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.

2. Repairs under warranty do not extend the warranty period either for the device or for the replacement parts.

3. The following is excluded under the warranty:
   • All damage which has arisen due to improper treatment, e.g. nonobservance of the user instruction.
   • All damage which is due to repairs or tampering by the customer or unauthorized third parties.
   • Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service center.
   • Accessories which are subject to normal wear and tear.

4. Liability for direct or indirect consequential losses caused by the unit is excluded even if the damage to the unit is accepted as a warranty claim.

Manufactured for
Compass Heath Brands Corp
Toll Frea 1888 549 4945
Richmar oo .
richmarweb.com
346521074 ©2021 Compass Health Brands Corp,

Documents / Resources

| Richmar Intensity Select Combo Tens EMS IF and Microcurrent Electrotherapy [pdf] Instruction Manual
Intensity Select Combo Tens EMS IF and Microcurrent Electrotherapy, Select Combo Tens EMS IF and Microcurrent Electrotherapy, Tens EMS IF and Microcurrent Electrotherapy, IF and Microcurrent Electrotherapy, Microcurrent Electrotherapy, Electrotherapy
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References

• Home Medical Products For Seniors, Elderly, Surgery Patients
• Home Medical Products For Seniors, Elderly, Surgery Patients

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