DOCUMENTS

ReGen Pod Manual

Pod User's eManual Version 19.09.30:1 (Click on the BULB sign to expand each section)

This is a non-controlled version of the pod manual for general use before the purchase of a pod. It may contain errors. This manual cannot be published or given to anyone without the expressed permission of BioPhotonica.

When used correctly, the Whole Body PBM pod is the ultimate tool to get a controlled release of ATP and use established pulsing frequencies to change the energy levels in the body. Many of the factory protocols and pulsing presets have names associated with illnesses but these protocols and pulsing preset are not intended to cure or treat those conditions. They are provided only as tools to be prescribed by a primary care physician. They can be used to support general wellness for people with these conditions.
Once you understand the photobiological mechanisms and the subsequent physiological effects, the Pod whole body PBM pod becomes a powerful tool providing great benefit for your patients and your business. We wants you to use it extensively and successfully and for that reason we strongly recommend that you attend one of our training courses. Please use the link at the top of the page to checkout our website where you can also join our mailing lists for future training dates, product information, conference announcements and medical news. This will help you stay up-to-date with this fast developing science and achieve the best possible results.
There are safety issues to be aware of and regulations that differ from one country to another so you should make sure that you are informed about these also. The manufacturer wants you to do well so read this manual starting with the safety information, follow instructions, attend our training courses, subscribe to our news, and contact us if you need help via the web at the link at the top of this manual.

The Pod may have unlimited users on a system but each Pod has only one “owner”. The owner can configure the system to meet their specific needs using the included app.

The Pod is complies with the international safety standard IEC 60601-1.

WARNING: – No modification of this equipment is allowed.
WARNING: – To avoid risk of electric shock, this equipment must only be connected to a supply-mains with a protective earth.
WARNING: – Do not open or attempt to modify this equipment in anyway. Failure to comply may result in electric shock or hazardous exposure to red/near
infrared (NIR) light.
WARNING: – The emergency stop shuts down all the control circuits and this will turn off the main power relay. 220 volts is still live inside the pod, even when in emergency stop is activated. – The Pod can pulse the visible red lights as low as 1Hz. Pulsing frequencies less than 60 Hz can cause seizures in epileptics. Users must be screened for light sensitivity or owners must turn on the epileptic safety override on the setup page. 
– There are no user replaceable light emitters in the Pod.
– Only use the Pod supplied power cable and connector. Do not use the Pod if the mains lead is damaged.
– For professional use only.
– Do not use the Pod near water, in or around damp locations or if you or the client is wet. Failure to comply may result in electric shock.
– Do not wear prescription glasses when operating or using the Pod. Failure to do so may result in eye damage.
– Do not operate the Pod unless you have been properly trained and you have read this user manual. Keep proper documentation of all training and certifications.
– High temperatures produced in normal use of the LED equipment may ignite some materials (e.g. cotton wool when saturated with oxygen) and solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser equipment is used.
– Do not use the the Pod when the room temperature is above 80°F (27°C).
– Client weight limit for the Pod is 450 lbs.
– Turn the power off to the the Pod before cleaning and surface wipe-down.
– If user feels uncomfortable for any reason they should immediately pause the treatment.

Do not wear prescription glasses when operating or using Pod. Failure to do so may result in eye damage.
Do not treat a user that is pregnant.
Do not treat a primary or secondary carcinoma.
– The Pod can pulse the visible red lights as low as 2Hz. Pulsing frequencies less than 60 Hz can cause seizures in epileptics. Users must be screened for light sensitivity or owners must turn on the epileptic safety override on the setup page.

Your Whole Body Light Pod consists of a spring counterbalanced upper arch cover (canopy) with a flat lower base (bench) for easy access in and out of the pod. This light pod uses LEDs arranged to emit Red (visible red light) from about 1/3 of the LED strips and Infra-red from the remaining LED strips. The light from infra-red LEDs is invisible so they always look off but the system knows when there is a failure in the infra-red emitters.
This system is WiFi connected and all the programs for the system are stored on a cloud server. When the system boots up, it checks the cloud server and automatically downloads a set of “standard” non-adaptive protocols. If it can not connect to the cloud, it will use the last set of downloaded programs. You can also send a user “adaptive” specific program to the pod using the included programs.
Adaptive protocols adjust the treatment time to accommodate for patient size and skin color. Darker and larger users will have longer treatment times. This is the best practice for any PBM system. System owners can use factory protocols, download 3rd party protocols from the app store or create custom protocols using the app or kiosk. This system is the state-of-the-art in Photobiomodulation and is a continuous improving device. Software upgrades may be installed overnight as required to improve the system.

Why are only some of the lights on during a session?
2/3 of the LEDs are emitting invisible infra-red light. They are on but you can not see this wavelength of light.

What is main difference between red and infra-red light?
Red light is quickly absorbed by the melanin in skin and the hemoglobin in blood. Infra-red light (with in the therapeutic window) can travel through tissue much more efficiency allowing a deeper chemical reaction when it interacts with the mitochondria in each cell to product ATP.

What are the wavelengths used in the Pod?
The Pod uses 633Hz, 810Hz, 850Hz and 940Hz with about 1/3 of the energy being visible red. The 810nm, 850nm and 940nm wavelengths are all within the the optimal window for maximum depth of penetration of light. The 633nm is absorbed closer to the surface of the skin.

The Pod has the following intended uses:
– To promote general wellness through photobiomodulation
– To apply red and IR light to tissue, joints, and muscles
– To generate advanced pulsed light fields associated with wellness
– As an adjunct to primary obesity therapy as part of a diet and exercise program.

INTENDED PATIENT POPULATION
Age: There are no age limitations but children under the age of 18 should get a reduced dosage.
Weight: Limited to 450 lbs (200kg.)
Height: Up to 81 Inches can be illuminated. Users who are taller may allow their feet to stick out the bottom or bend their knees.

INTENDED PART OF THE BODY APPLIED TO
All external parts, the whole body.

INTENDED USER PROFILE
The Whole Body Light Pod is designed for use by a trained personnel . The Pod can be used by:
Medical doctors
Physiotherapists
Nurses
Other therapists

INTENDED CONDITIONS OF USE
Environment: Indoors Only

In addition to the precautions about eye safety, there are several other precautions that should be observed during treatment with a cold laser. There is no evidence that any damage has been caused by the use of cold lasers but it is better to be conservative. The following condition require special care:

1. Be careful treating children and sensitive adults. Start with a the smallest dosage (like the 1st timer program) for the first treatment.
2. Avoid treating someone with a fever.
3. Avoid treating or significantly reduce the dosage for patient that may be photosensitive or have a stronger reaction to light like patients that are taking any light sensitive drugs including thyroid medication, Retin-A, tetracycline and St. John’s Wort.
4. Some practitioners avoid using PBM on patients with thyroid issues as PBM can increase thyroid production.
5. Be cautious when treating tattoo areas. The dark pigments may cause the skin to become hot.
6. Suspend therapy if the patient is feeling pain from the treatment or if they have any unusual reactions to the therapy.

Here are the most important contraindications:
1. Avoid treatment during pregnancy unless under the supervision of a primary care physician.
2. Do not treat a known or suspected cancer or tumor without approval from an oncologist or primary physician. A Pod treatment may be given for pain relief during the terminal stages of the illness. The manufacturer recommend this be done only with the informed consent of both patient and consultant involved.
3. Do NOT treat patients that are on immune suppression therapy because the light may boost the immune system.
4. Do NOT treat directly over a bacterial infection. PBM increases the blood flow and that could help spread the infection.
Pins, Metal Plates and Plastics are NOT Contraindicated: Laser may be safely used over stitches as well as metal implants, pins, plates and plastics.

PHOTO-SENSITIVITY REACTIONS
Avoid treating or significantly reduce the dosage for patient that may be photosensitive or have a stronger reaction to light like patients that are taking any light sensitive drugs including thyroid medication, Retin-A, tetracycline and St. John’s Wort.
CANCER
Do not treat a known or suspected cancer or tumor without approval from an oncologist or primary physician.. A Pod treatment may be given for pain relief during the terminal stages of the illness. The manufacturer recommend this be done only with the informed consent of both patient and consultant involved.
REACTIONS TO TREATMENT
Patients may report a number of sensations, such as localized feelings of warmth, tingling, or an increase or decrease in symptoms, within the 24-hour period immediately following ReGen Pod treatment. Other sensations that may be experienced in response to Pod therapy are nausea or dizziness. In patients with persisting or severe treatment reactions, the Pod treatments should be discontinued.
PINS, METAL PLATES, PLASTICS AND PACEMAKERS
The Pod may be safely used over metal implants, plastics and stitches and on patients fitted with a pacemaker.
HYGIENE
Observe general clinical hygiene standards and protocols.

The Pod needs to be installed in a well-ventilated room that is temperature controlled. The ideal room size is approximately 14 feet x 14 feet and the minimum room size is 12 feet x 10 feet, which allows room for the patient to prepare and enough air space to maintain a comfortable ambient room temperature. The Pod is designed to be a stationary unit requiring floor surfaces to be solid and flat to prevent unintended movement. Air from the room is used to cool the Pod:
• To be operated indoors in a dry well-ventilated environment without any contact with liquids.
• Maximum ambient room temperature should be 27°C (81°F) or less.
• Place the Pod no closer than I inch from any wall.
• Ensure nothing obstructs the airflow at each end of the canopy and bench and out of the fan openings.
• A poorly ventilated room may cause the unit to become hot and cause discomfort to the user.
• A qualified electrician is required to install room wiring to meet the local regulations for mains power supply to satisfy the Pod power requirements as specified in this manual.

Room Air Conditioning Requirements

The requirements for the room air condition are based on peak usage. The following chart shows the A/C requirements in tons for both the Q4 and Q8 systems based on the percentage of time that the system is on. In most applications, the maximum usage will be 90%. The numbers shown are the ADDITIONAL cooling requirements based on the addition of a Pod to the existing building load. For a typical Q4 installation, the room will require an additional 1 ton (12,000 BTU/hour) of cooling.

The electrical circuit where the Pod is installed must comply with state and local electrical requirements. This system uses more power than typical appliances and requires special care to make sure that the entire circuit is up to regulations.
For Pods with less than 6000 watts of specified power, the systems are designed to operate off a 4-wire 208 – 240 volts circuit with a 30 amps breaker. The system may be use on 2-phase or 3-phase power but the current draw will be about 15% higher when using 3-phase power. This system is designed for a standard 4-wire configuration(+110 volts, -110 volts, ground and neutral). A 4-wire installation allows users to plug the kiosk power cord into the back of the Pod for a cleaner install. This is preferred for commercial installations.
If the system is converted to a 3-wire device, the system will not have a grounded frame. In the event of an electrical fault, the 4th wire insures that the frame can not conduct electricity to a user. The system comes installed with a 6-foot 10-gauge 4-wire cable and standard “dryer” plug. This cable can be replaced with an equivalent twist lock cable if required.
Per the electrical standard, the left and right blades on the connector are the +120 and -120 volt legs. The round or D-shaped pin is the GROUND and the straight or L-shaped blade is the NEUTRAL. As a 4 wire device, The ground wire (typically green in the US) is attached to frame of the pod.

The Q8 system requires a circuit 50-amp breaker, electrical wire and outlet. The gauge of the wire is dependent on the length of the wire from the breaker box to the plug. This installation will be similar to a standard dryer.

Please see the training manual for complete information for using the Kiosk, App and internal touchscreen to control the Pod.

Pod Wi-Fi Setup

Both the Pod and the Kiosk requires WiFi access to move programs between the kiosk. cloud and Pod. At the bottom of the internal display is the unique name given your Pod. This is the universal identifier for this system similar to a serial number.

  • If the name of the pod is shown in Green, the system has a good WiFi connection.
  • If the name of the pod is shown in Yellow, the system is attached to the internet but not to the database.
  • If the name of the pod is shown in RED, then the system does not have a good WiFi connection. When this happens the system starts searching for WiFi connection. If it does not find one, it will turn itself into an Bluetooth hot-spot. Using a phone or tablets with Bluetooth turned on, go to your Bluetooth settings and click on the Pod option. Once you attach to the pod through Bluetooth, the system will help you setup the WiFi connection for the Pod on your mobile device. Select a network and add the password. The system will complete the WiFi setup process.

Kiosk WiFi Setup

The Kiosk is driven from an 12.9 Ipad pro. This system also requires WiFi setup when it is first used in a new facility. Please follow the standard Apple instructions for adding the kiosk to the network. You are not required to buy any additional services through Apple to use this interface but you may choose to add additional features.

Kiosk Lock-down

If the Kiosk is being used as a self serve interface to the pod, you can increase the security and reliability by putting the Ipad in Guided Access Mode. This will only allow the self serve application to be executed on the Ipad.
To initiate Guided Access mode on the Ipad, go to Settings Icon and Select General > Accessibility > Guided Access
Flip the switch to on (green) position. Exit settings.
Now open the self serve program and then triple click the start button.
Then select Guided Access and Done. To take the Ipad out of Guided Access mode – triple click the start button. You may need to do this to change WiFi setting or do software updates.

The Pod has a built in Bluetooth receiver and amp. This system can only attached to one Bluetooth device at a time so you must be un-paired with the currently paired device before you can pair it to another device. If the system is not paired to a device, it will be constantly searching for a device to pair to. It will be seen as “XY_BT” in the list of available devices on your personal device. Just click pair. The system will say ” The bluetooth device is connected” when the pairing is successful. There are no security settings for the amp and speakers as they are not connected to the main processor on the Pod.t

Light therapy stimulates blood flow, cellular energy (ATP), immune and anti-inflammatory effects (inflammation may go up before it goes down). The effect may be felt more by some people than others (tiredness, pain or maybe vitality and euphoria). For personal comfort, the manufacturer strongly suggests that the first session be a brief 5 minute trial and that users slowly build up to the maximum treatment of 20 minutes. The manufacturer recommends a combination of both Red Light and NIR for normal treatments. The following shows average energy distributions based on time for several systems.

Wavelengths: The system supports individual control of the 4 wavelengths 633nm, 810nm, 850nm, 940nm in order to apply dosage.
Pulsing: The system supports continuous wave, simple and complex pulsing to stimulate the body energetically.
Irradiance: 25 mW/cm2
The main setup and control features are accessible through the app or kiosk. The internal display allows user to select a program from a list (created on the app or kiosk) and start, pause and stop the system.
Max Time Watch-dog: This is software configurable system and is factory set to a maximum treatment time of 20 minutes.
Pulsing Watch-dog: This is software configurable and, when turned on, limits the pulsing of the visible red LEDs to no less than 60Hz. Voltage: 208 – 240VAC 50/60Hz .
Operating Temperature: +50°F (10°C) to +80°F (27°C)
Humidity Range: 30% to 75% RH (Non condensing)

The Pod complies with international standard IEC 60601-1-2 General Requirements for Basic Safety and Essential Performance Collateral Standard.

‘The typical EMF inside the system is 8mG. This is significantly less than most electronics. The system produces about 1/5 of the EMF near a PC and about 1/30 the EMF near a microwave.
There should be no significant risks of reciprocal interference between this and other equipment in any of the treatment modes. Nevertheless, care should be taken in order to minimize those risks. Please refer to the following.
a. Avoid close proximity of other systems and equipment.
b. Avoid close proximity or crossing of the cabling associated with other systems and equipment.
c. Confirm, if possible, EMC approvals of other systems and equipment that are in close proximity.
d. Use a filtered power source (mains supply) if available.

NOTE: When ever cleaning is conducted on the ReGen Pod, the power must be OFF and/or the main power cable should be unplugged. Use only small amounts of liquid clean and do not let it come in contact with any electrical components. Always unplug the system if any covers are uninstalled.
SUGGESTED INSPECTION
Make regular inspections of your Pod to insure proper and safe operation. It is recommended that daily inspections are made prior to first use to insure all components are working properly.
Weekly/Monthly inspections should be made as follows:
Inspect the unit’s fasteners verifying that all are firmly in place. Pay particular attention to the hinge bolts. Loose fasteners should be immediately tightened.
Inspect the counter-balance steel cables. Contact service if they do not hold the canopy up in the full open position.
Inspect the white, acrylic panels for damage. Broken, cracked or badly scratched acrylics should be immediately replaced.
Inspect for burned out diodes. If there are more than 500 diodes visibly out, contact the factory. There are up to 46,000 diodes in the system so having a few out does not affect the performance.
CLEANING
Clean and disinfect the Pod’s bench after each use. Infections can be spread through skin contact, all components which can come into contact with the user during a treatment must be disinfected after every use, this includes:
– Acrylic panels
-Head rests/pillows
-Handles, control panel and Light pod frame
The manufacturer recommends a pH Neutral, non-abrasive disinfectant cleaner, surfaces must remain visibly wet for 10 minutes. Use a disinfectant cleaner that does not contain ammonia or ammonia derivatives. Ammonia may damage the acrylic surfaces. Spray the acrylic lightly with disinfectant and wipe dry with a clean lint free cloth.
The manufacturer recommends Tersano™ cleaner for sanitizing and/or disinfecting the Pod. It will leave the glass streak-free while sanitizing the pod.
A thorough wipe down should be done at the end of each operating day to insure the surfaces are free of dirt, grease, oils, etc.

Internal Display is DarkIs the ReGen Pod plugged into the mains power? Check the source of mains power. Does the circuit breaker need to be reset on the Pod? Is the mains supply switched on? Check the circuit breaker for the mains socket, does it need to be reset? Check to make sure the emergency stop button has not been depressed by rotating the red emergency stop button clockwise to release.
Internal Display is DarkIf the internal display is not illuminated, check that the emergency stop button (big red mushroom shape button has not been depressed (rotate button clockwise to return to the normal operating condition).
Circuit Breaker tripsReset circuit breaker. If the circuit breaker continues to trip, contact the manufacturer using the link at the top of this page.
The Kiosk is not downloading to the PodConfirm that the Pod has an internet connection by looking at the bottom of the display inside the pod. If the “IP name” of the pod is RED, it is not connected to the internet. If the name is yellow it is attached to the internet but it is not communicating with the database. If the name is GREEN, it is connected and constantly download new data.If the ” IP name” is red, use a phone or Tablet with Bluetooth to attach to the Pod, Make corrections to the internet setup so that the Pod is connected and the IP name at the bottom of the display is GREEN.
Canopy fails to stay in the up or down positionSpring located on either side of the lower base should hold the canopy fully up as well as allow it to rest fully closed. If the canopy is left up for an extended period of time it may creep down, this is considered normal.,Keep the canopy closed when not in use. If the springs no longer have sufficient power to hold the canopy up in the raised position, contact your www. regenpod.com Customer Service for replacement parts.

SYMPTOM ACTION

LEDs do not stay litCheck the source of AC power. Reset circuit breaker on the ReGen Pod at the main electrical panel.
Unit seems unusually hotEnsure cooling fans are running.
Allow the Pod to cool before resuming treatment.
Ensure that fan guards and fans are clean. If the unit is too close to a wall, it should be moved away to ensure proper ventilation.
If the room temperature is too high (without the influence of the bed), increase ventilation / air conditioning.
3 YEARS STANDARD WITH AN OPTIONAL 5 YEAR CONDITIONAL WARRANTY: The manufacturer warrants that the Pod will function and perform within specification for three years from the date of delivery. This is automatically extended for another three years, if serviced by the manufacturer under a separate maintenance agreement, every year continuously up to a maximum of five years. This warranty covers all parts, labor and shipping during the warranty period with some exclusions (see below). WARRANTY EXCLUSIONS: The warranty shall not apply to equipment that has been abused, modified or damaged, or fitted with substitute parts other than parts supplied by the manufacturer. The manufacturer shall not be liable for any consequential loss or inconvenience caused by any failure of its products. In the unlikely event that the product fails within the terms of the warranty, shipping and repairs will be performed at no charge. The manufacturer maintains a network of trained service professionals to handle in-field service and repairs. To schedule a service call, use the links at the top of this page to contact service.
 

This marking on the product and literature indicates that the product and its accessories should not be disposed of with other commercial or household waste at the end of their working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate these items from other types of waste and recycle them responsibly to promote the sustainable reuse of material resources. Household users should contact either the retailer where they purchased this product, or their local government office, for details of where and how they can take these items for environmentally safe recycling. Business users should contact their supplier and check the terms and conditions of the purchase contract. This product and its accessories should not be mixed with other commercial wastes for disposal.

The manufacturer makes no claims, representations or warranties regarding the ability of this product to cure any physical or mental conditions. A qualified health professional should be consulted with regard to any condition requiring medical attention. This product is not intended to diagnose, treat, cure or prevent any disease. Consult your physician before beginning any exercise program. Neither the manufacturer, the Pod, its officers, employees or agents, nor the author of this manual, hold that the application of laser medicine and phototherapy will achieve any or all of the benefits referred to or implied in this text or in any other materials prepared or supplied by the manufacturer. There may be other dangers or consequences associated with the use of laser medicine and phototherapy, known or otherwise, which are not referred to in this manual. Whilst the manufacturer has taken all possible care in the design and manufacture of this laser unit, no responsibility can be taken by the manufacturer for the way in which it is used. The user operates the laser unit at their own risk. The manufacturer will not accept any liability for any injury or damages resulting directly or indirectly from the use of the laser unit and any associated equipment, or the information contained in this manual or any other materials or advice provided by the manufacturer to the purchaser or any officer, employee, or agent of the purchaser.

Use the information at the bottom of the page to contact us for service or to purchase additional products and services.
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