User Manual

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

Medical device

Electronic Stem Generator

User Manual

 1370

This manual was created by the Electronic Stem Generator manufacturer, ZIR IMPLANT SRL and is

an official, required reference to the proper use of the device

All devices produced by ZIR IMPLANT SRL are RoHS compliant

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 1 of 40

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu  
Electronic Stem Generator – User Manual  
TABLE OF CONTENTS  
INTRODUCTION4
1. ELECTROMAGNETIC THERAPY AND PROLIFERATION OF STEM CELLS6
2. PRECAUTIONS AND WARNINGS7
3. OBJECTIVES10
4. INDICATIONS FOR USE11
5. CONTRAINDICATIONS AND PRECAUTIONS12
5.1. Contraindications12
5.2. Precautions12
5.3. Undesirable side effects12
6. SYMBOLS13
7. THE OPERATING ENVIRONMENT OF Electronic Stem Generator14
8. DESCRIPTION OF Electronic Stem Generator17
8.1. Generator of Sinusoidal Signal Module17
8.2. Accessories of Electronic Stem Generator18
8.2.1. The Dental Applicator, code: DAP18
8.2.2. The Facial Applicator, code: FAP19
8.2.3. Battery Charger, code: BCH19
8.2.4. Applicator Connector, code: ACN20
8.2.5. USB Service Connector, USBC20
8.2.6. Protective hard case20
8.3. Principle of operation21
8.4. Clinical benefits22
8.5. Performance characteristics22
9. INSTALLATION OF Electronic Stem Generator23
9.1. Unpacking23
9.2. Cleaning and decontamination of Electronic Stem Generator before use23
9.3. Charging the batteries24
9.4. Moving the Electronic Stem Generator25
10. COMPUTER SPECIFICATIONS THE ESG_USB_Update APPLICATION26
11. INSTALLATION & ACTIVATION OF ESG_USB_Update APPLICATION27
11.1. Installation/Activation of ESG_USB_Update Application27
11.2. Loading of therapy hours27
11.2.1. Online activation of therapy hours30
11.2.2. Phone activation (Call Center) of therapy hours30
12. NECESSARY PROGRAMS FOR UPTADING OF THERAPY HOURS31
13. USB CABLE INSTALLATION32
14. OPERATING INSTRUCTIONS33
14.1. Preparing for use33
14.2. Putting into operation of Electronic Stem Generator33
15. SERVICE35
15.1. Background35
15.2. Loss of warranty35
15.3. Description of defects35
15.4. Handling of Electronic Stem Generator before shipping35
15.5. Shipping36
No. 004.004-EN, Edition 1, Revision 4, November 2018Page 2 of 40 

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu www.stemgenerator.eu

Electronic Stem Generator – User Manual

16.Electronic Stem Generator SPECIFICATIONS37
17. LABELING OF Electronic Stem Generator38
18.RECYCLING OF Electronic Stem Generator39
No. 004.004-EN, Edition 1, Revision 4, November 2018Page 3 of 40

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

INTRODUCTION

Thank you for choosing the cellular regeneration therapies developed and implemented by the means of the Electronic Stem Generator.

It is required to read through these pages before first connecting, turning on, or using your device and to always keep this document as a reference for future uses of your Electronic Stem Generator.

Please read this document thoroughly. Should you have any questions, please contact the representative from whom you purchased the device.

Electronic Stem Generator devices are medical devices which produce visible results which can be objectively measured through clinical methods. The treatment with the electromagnetic field of low frequency is no longer a secret, covering at this moment many fields in cosmetics and medicine

CAUTION!

The Electronic Stem Generator is not intended for use by persons (including children) with reduced physical, sensory or mental capabilities, or lack of experience and knowledge, unless they have been given supervision by a person responsible for their safety. Children should be supervised to ensure that they do not play with the device.

Installation and operation of Electronic Stem Generator – Warnings

WARNING: Electronic Stem Generator must be installed and put into operation according to the information in this document.

Yours faithfully,

ZIR IMPLANT SRL’ Team

Copyright

This document is the intellectual property of ZIR IMPLANT SRL. Any form of reproduction, partial or total use thereof is permitted only with the written consent of the company.

This document has been prepared on the basis of ZIR IMPLANT SRL, in accordance with the current level of knowledge. ZIR IMPLANT SRL reserves the right to revise or amend schemes or any other details manually without customer notification. For any change, the revised document will be made available to the competent authorities.

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 4 of 40

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

ZIR IMPLANT SRL cannot provide any guarantees regarding information from other sources and accepts no responsibility if they are used.

User of Electronic Stem Generator is not authorized to replace any accessory or component thereof, except those described in this document, for conducting current maintenance operations.

NOTE:

On request, send to ZIR IMPLANT SRL by e-mail (bogdanvladila@yahoo.com), we can send to you this manual on paper form within 7 calendar days at no additional cost to the user.

NOTE:

Our website, www.stemgenerator.eu, where you downloaded this manual fulfill requirements of personal data protection, according to Directive 95/46/EC on the protection of individuals with

regard to the processing of personal data and on the free movement of such data.

WARNING:

The device must be used only when the batteries are the main power source.

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 5 of 40

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

1.ELECTROMAGNETIC THERAPY AND PROLIFERATION OF STEM CELLS

The greatest potential is offered by Embryonic Stem Cells, which posess “totipotency” in the earliest stages of embrionic development (up to the blastocyst stage).

Adult stem cells are generally, only “multipotent”, except for the umbilical cord wharton jelly, where are still located pluripotent stem cells. The umbilical cord blood also is rich in hematopoietic stem cells.

There are etical restriction that prevent the use of human embrionic stem cells, as well as the use of fetal stem cells.

However, the use of adult stem cells (such as wharton jelly stem cells, umbilical cord blood stem cells) or of mesenchimal stem cells and adipose stem cells is permited, and their use in regenerative medicine is under intense investigation.

Umbilical cord stem cells are currently collected and stored in cell banks, being available in case of need, for “autologous” transplantation. One major problem is content of stem cells in cord blood, which does not permit the treatment of an adult.

Alternative sources of stem cells are “mesenchymal stem cells” (or “bone marrow stem cells”) to be found in many tissues, but readily available from bone marrow, and adipose tissue stem cells. For the typical MSC, differentiation is possible into osteocytes, adipocytes, chondrocytes, myocytes (smooth, skeletal and cardiac). The same differentiation patterns are possible for adipose derived MSCs.

More elaborate tests have proved the potential of these cells to differentiats into cells of the ectodermal layer (e.g. hepatocytes).

Apart of these, there are also the IPS (induced pluripotency stem cells), that have the general potential porvided by ESCs, but there are more safety concern for the use of these cells in regenerative medicine.

For the adult, the most convenient source of stem cells seems to be adipose tissue; at the same ratio of stem cells, adipose tissue is available in larger amount than any other tissue, so it seems that is worh investigating this source and its potential applications. Secondary sources are also stem cells in the oral mucosa and in the dental pulp.

No matter the origin of these stem cells, their availability is very limited, and usually, the quantity of cells is rarely achieved only by isolation, therefore a step (or steps) of in vitro propagation are needed to reach the optimal amount of cells.

While media and supplements have been designed for in vitro propagation and for induction of differentiation towards various lineages, additional means to stimulate proliferation of stem cells are needed, in order to obtain larger amounts of cells and shorter the time for their proliferation. One such approach is the use of Electronic Stem Generator device, which, in tests on Adipose Derived Stem Cells provided an average stimulation of about 20%, with no interference to the stem cell behaviour and characteristics.

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 6 of 40

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

2. PRECAUTIONS AND WARNINGS

ATTENTION:

Do not use the Electronic Stem Generator if you are in doubt regarding its proper functioning or any other problem!

Do not use the Electronic Stem Generator in locations where flammable or explosive substances are found.

Before using the Electronic Stem Generator, you must make sure that the solvents and flammable solutions used for cleaning and disinfection have evaporated completely. You also need to pay particular attention to the risk of ignition of endogenous gases!

ATTENTION:

Only use the power supply provided with the Electronic Stem Generator; use of other elements can damage the device!

Connect the Electronic Stem Generator only with the USB port of your computer!

 Read all instructions, cautions and warnings before use. The Electronic Stem Generator is intended for the exclusive use by persons with normal physical, sensory and mental capabilities with experience and knowledge appropriate to their age (over 18 years). The Electronic Stem Generator Device is not intended for use as the sole method of treatment of diseases listed in Chapter 3 of this manual and cannot substitute for approved medical opinions.

Patient and user safety – WARNINGS

WARNING: NEVER connect the wet charger to the electrical wire. NEVER use wet hands when in contact with the device. Always ensure that the voltage on the rating label of the charger corresponds to the mains voltage in your home. Always connect the charger to a proper electrical outlet – 230 V AC

WARNING: Connect the charger and the applicator to the appropriate muzzle. An incorrect connection can have as a result the failure of the device.

WARNING: Keep the Electronic Stem Generator away from children and pets. Penetration in the mouth of hair or stains from pet can cause contamination and/or respiratory health problems.

WARNING: Users should check the Electronic Stem Generator, ensuring that it is sufficiently clean, before each use, to avoid contamination.

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 7 of 40

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

WARNING: Do not strangle the connection cable; this can cause the malfunction of device.

WARNING: People with implanted electronic equipment, such as pacemakers and intra- cardiac defibrillators, must not use the Electronic Stem Generator.

WARNING: Pregnant women should not be treated with Electronic Stem Generator.

WARNING: Therapy should not take place while the user is connected to high-frequency surgical equipment. It may cause problems with the stimulator.

WARNING: Do not use the Electronic Stem Generator in the vicinity of shortwave or microwave therapy equipment, since this may affect the output power of the device.

WARNING: Do not use the Electronic Stem Generator on a gas or electric cooking top or over or near an open flame. Keep the device far from heat and hot surfaces.

WARNING: Never use the device while you are sleeping.

WARNING: The supply cord of recharging connector cannot be replaced. If it is damaged, the recharging connector is no longer usable. Using a damaged supply cord can result in electric shocks.

WARNING: Do not store or use the device in environments with excessive humidity, dust, and oily aerosols or where in can be splashed with water ping.

WARNING: The personal computer must not be situated closer than 1.5 m from user.

WARNING: Use of Electronic Stem Generator device is a complementary therapy and does not replace conventional treatment. Do not interrupt or modify the current treatment protocols recommended by a physician.

Maintenance of Electronic Stem Generator – Warnings

WARNING: Do not immerse the Electronic Stem Generator and do not allow liquids to moisten the device or component.

WARNING: Do not attempt to sterilize the Electronic Stem Generator by wet or dry heat methods.

WARNING: Disconnect the Electronic Stem Generator from mains voltage supply before cleaning.

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 8 of 40

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

WARNING: Electromagnetic Interference (EMI) can affect the proper performance of the Electromagnetic Stem Generator. It can return to normal operation by eliminating the source of interference.

WARNING: Do not attempt to open, disassemble or service the Electronic Stem Generator. Do not crush, puncture, short external contacts, do not dispose them in fire or water. Do not expose to temperatures exceeding 550C.

WARNING: Examine the presence of defects on the supply cables / connectors and components. In case of any defect, do not use the Electronic Stem Generator until its replacement.

WARNING: To reduce the risk of fire or electric shock, use only the recommended accessories and do not expose the Electronic Stem Generator to rain or moisture. Do not disassemble; device contains no parts that can be repaired by the user. For troubleshooting, call ZIR IMPLANT SRL service personnel or qualified and authorized by ZIR IMPLANT SRL personnel.

WARNING: Use only accessories and spare parts supplied by ZIR IMPLANT SRL; Use of other accessories can reduce the operational safety of the Electronic Stem Generator.

WARNING: It is not permitted any modification of these s.

Use of Electronic Stem Generator – Warnings

WARNING: Is forbidden the use radio transmission equipment, mobile phones, etc., in the vicinity of the Electronic Stem Generator, because it can affect the performance.

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 9 of 40

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

3. OBJECTIVES

This User Manual is created by the manufacturer, ZIR IMPLANT SRL. It supplies the basic information and operation of the ESG_USB_Update software and device interface. This manual does NOT provide medical interpretation or medical advice in any way.

Any statement within the manual is not intended to indicate a medical claim or diagnosis or therapy facility for a specific condition. The use of any facility described should not be considered as approaching or substituting in any way for medical advice, diagnosis or therapy. Patients and users of the Electronic Stem Generator should exercise due diligence in ensuring that they are informed and consult with a licensed healthcare practitioner.

Any statement within the manual is not intended to indicate a diagnostic claim. Only a licensed diagnostician can diagnose with any information available under the diagnostician’s expertise. The device is for medical electromagnetic therapy only.

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 10 of 40

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

4. INDICATIONS FOR USE

Electronic Stem Generator is used in on treatment of dental diseases, such as:

∙Predisposition to periodontitis

∙Periodontitis

∙Bone destruction

∙Postoperative and post-implantation recovery

by providing proliferation of stem cells with the aid of electromagnetic field.

As an adjunctive effect of treatment with medical device: Facial Applicator, in combination with Electronic Stem Generator, very favorable cosmetic results are obtained.

Indications for use – Warnings

WARNING: Do not use the Electronic Stem Generator for anything other than its intended use.

∙Therapy: the Electronic Stem Generator is recommended for daily use (sessions of 2 hours), depending on the severity of the disorder and the advice of the physician.

∙Use of Electronic Stem Generator is a complementary therapy and does not replace conventional treatment. Do not interrupt or modify the current treatment protocols recommended by a physician.

∙The Electronic Stem Generator is intended to be used by an individual person, according to details on the dental applicator label.

∙Interactions with other medications: Electronic Stem Generator may be used together with any other medications.

WARNING: Before use, you must make sure the batteries are charged so that they can sustain a therapy session that lasts 2 hours. The battery level indicator is displayed on screen immediately after pressing the ON/OFF button.

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 11 of 40

SC ZIR IMPLANT SRL

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19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

5. CONTRAINDICATIONS AND PRECAUTIONS

5.1.Contraindications

Do not use on people with epilepsy or a history of epilepsy

Do not use this device on people with a pacemaker

Do not use on people with electrical hyper reactivity

Do not use on pregnant women

Do not use on in people under 18 years

Do not use on people who are under the influence of drugs or alcohol

Don not use on people with hemorrhages

Do not use on people with cancerous tumors

5.2.Precautions

The Electronic Stem Generator is not intended for use by persons (including children) with reduced physical, sensory or mental capabilities, or lack of experience and knowledge, unless they have been given supervision by a person responsible for their safety. Children should be supervised to ensure that they do not play with the device

Use caution with psychotic persons or persons with histories of electro-shock

Use this device only powered from batteries, free from wall current.

5.3.Undesirable side effects

A slight feeling if light-headedness after a session. Please note that this may be due to the patient’s own health such as high blood pressure or the sudden standing up after being in a relaxed, reclined position during the session. If this feeling feels in any way abnormal or of a concern, then the patient should see their primary healthcare practitioner

The patient might sweat excessively, report nausea and dizziness. If this occurs, place a cool wet rag over the eyes gently with light pressure, tell the patient to relax breathe deeply, and wait about 5 to 10 minutes for the vasovagal storm to pass

 Any serious incident that has occurred in relation to Electronic Stem Generator medical devices should be reported to ZIR IMPLANT S.R.L. and the competent authority of the Member State in which the user and/or patient is established.

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 12 of 40

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

6. SYMBOLS

ManufacturerYear of manufacture
Means that it is absolutelyCompliance with European
necessary for the user to readDirective 93/42 / EEC
the user manual before 
starting the utilization of the 
device 
Type BF piece withThe serial number
application to the patient 
 This symbol, adjacent to a
Product referenceterminal, indicates that, under
 normal use, hazardous
 voltages may be present
 The European Union logo on
Double insulationwaste electrical and
 electronic equipment. Allow
 return for proper disposal
Thermal limitsHumidity Limits
Do not use if package isKeep dry
damaged 
Fragile, Handle with careRecyclable packaging
No. 004.004-EN, Edition 1, Revision 4, November 2018Page 13 of 40

SC ZIR IMPLANT SRL

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19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

7. THE OPERATING ENVIRONMENT OF Electronic Stem Generator

Environment – Warnings

WARNING: Protecting the patient and the user is essential and a requirement of the laws. Injuries can be caused from two sources:

∙A short circuit when the current is directed to the ground by the patient

∙Surge and lightning.

They may not happen when the generator of sinusoidal signals uses only the batteries as power source.

Injuries can be avoided by plugging the power cord from the battery charger and checking regularly for any damage. If the cord or the plug is damaged, it must be replaced by the manufacturer or qualified person in order to avoid an electrical hazard.

WARNING: The dust and lint can affect the correct functioning of the device

The power supply of the Generator of sinusoidal signals of the Electronic Stem Generator

Voltage:3,7Vcc (batteries)

Temperature and humidity during use

The Electronic Stem Generator can operate within the limits of 15 – 300C. The air humidity must be in the range 30-80% at 250C.

Lighting

Lighting of the space where used Electronic Stem Generator is must provide optimum visibility to the user.

Chemicals and flammable

During therapy with Electronic Stem Generator, all flammable or combustible gases that are used in the space must be stopped. Substances or cleaning solvents or other chemicals must be stored in separate areas to avoid their self-ignition. Do not use the Electronic Stem Generator in the same space in the same time with devices that provide oxygen to patients with respiratory diseases.

Interference with other electronic devices

For optimum performance, it is recommended that all electronic devices such as cell phones, radios or other devices of this kind, to be at a distance of at least 1.5 meters. This reduces the potential for external interference.

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 14 of 40

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19 Razboieni street, Breaza, Prahova – Romania

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www.stemgenerator.eu

Electronic Stem Generator – User Manual

Electronic Stem Generator is designed to be used in typical domestic or clinical environments and is approved according to EMC safety standard of EN 60601-1-2.

      Electromagnetic compatibility        
              
               
  The Electronic Stem Generator is intended to be used in the electromagnetic environment specified   
  below. The user should make sure it is used in this environment         
                  
  Emission trial   Level test EN   Compliance   Electromagnetic environment –    
      60601       Guide        
                 
  Electrostatic discharge   ± 6 KV contact   ± 6 KV contact   The support should be wooden,    
  EN 61000-4-2   ± 8 KV air   ± 8 KV air   concrete or tile. If the support is    
              covered with a synthetic material; the  
              relative humidity should be at least    
              30%.        
              
  Far transient bursts   ± 2 kV for the   ± 2 kV for the   The main power supply quality should  
  EN 61000-4-4   feed cables   feed cables   be the one of a traditional commercial  
      ± 1 kV for the   ± 1 kV for the   or hospital environment     
      input/output   input/output            
      cables   cables            
              
  Voltage shocks   Differential   Differential   The main power supply quality should  
  EN 61000-4-5   mode ± 1 kV   mode ± 1 kV   be one of a traditional commercial or  
      Common   Common   hospital environment      
      mode ± 2 kV   mode ± 2 kV            
              
  Dips, brief outages   • <5% UT – for   • <5% UT – for   The main power supply quality should  
  and   10 ms   10 ms   be one of a traditional commercial or  
  power voltage   • 40% UT – for   • 40% UT – for   hospital environment      
  variation   100 ms   100 ms            
  EN 61000-4-11   • 70% UT – for   • 70% UT – for            
      500 ms   500 ms            
           
  Magnetic field with   3 A/m   3 A/m   The magnetic field with the network   
  the           frequency should be at a characteristic  
  network frequency           level of a location in a traditional  
  (50/60 Hz)           commercial or hospital environment  
  EN 61000-4-8                    
                 
  Conducted RF   3 Vrms   3 Vrms   PortableandmobileRF  
  EN 61000-4-6   150 kHz to 80 MHz   150 kHz to 80   communication devices should not be  
          MHz   used at a distance from the standard  
              ElectronicStem Generatorincluding  
  Radiated RF   3 V/m       the cables, lower than the  
  EN 61000-4-3   80 MHz to 2.5 GHz   3 V/m   recommendedseparationdistance,  
          80 MHz to 2.5   calculatedwiththeapplicable  
          GHz   formulas depending on the emitter  
              frequency.        
              Recommended separation distance   
              d = 1.16 √ P       
              d = 1.16 √ P 80 MHz to 800 MHz    
              d = 2.33 √ P 800 MHz to 2.5 GHz    
              Where P is the maximum rated output   
              of the transmitter in watts (W) by the   
              transmitter manufacturer and d the   
              recommendedseparation distancein   
              meters (m).        
                       
No. 004.004-EN, Edition 1, Revision 4, November 2018   Page 15 of 40

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Electronic Stem Generator – User Manual

The field levels emitted by the fixed RF transmitters, determined by an electromagnetic measurement of the site, should be lower than the compliance level in each frequency band.

Interference may occur in the vicinity of the devices bearing the following symbol: 

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www.stemgenerator.eu

Electronic Stem Generator – User Manual

8. DESCRIPTION OF Electronic Stem Generator

The Electronic Stem Generator contains the following:

∙Generator of sinusoidal signal module

∙eDoctor_USB_Device_Manager software, version 1.4

8.1.Generator of Sinusoidal Signal Module

Jack for dental/facial applicator connector

Command and control panel

ON/OFF

The Generator of Sinusoidal Signal Module, consists of a case comprising:

1.Basic PCB

2.Control panel

3.ON/OFF button

4.LCD screen

5.ACCU – size batteries NCR 18650 Li-Ion

The hole for the charger cable is on the right lateral side of the Generator of Sinusoidal Signal Module:

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Electronic Stem Generator – User Manual

The eDoctor_Device_Manager Software, version 1.4 is an application that runs the Electronic Stem Generator device to allow loading of therapy hours, together with ESG_USB_Update application.

8.2. Accessories of Electronic Stem Generator

8.2.1. The Dental Applicator, code: DAP

The Dental Applicator, code: DAP, is a custom-made medical device; its components

are:

1.Coil with a support made of galvanized blackboard

2.Foils made of biocompatible silicone (same as dental trays)

3.Cable for connection to Generator of Sinusoidal Signal Module

The assembly is designed so that generates field lines between the two parallel walls of the tray and placed sideways from of the dental arch. The magnetic field pervades the dental arch and allows the proliferation cells of interest.

The distance between the two walls of the total tray is given by the metal support that is custom made according to the size of the arch of the patient on which is carried-out electromagnetic field exposures. Size of the metallic support is defined by arch footprint and the realization of the model in dental laboratory.

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8.2.2. The Facial Applicator, code: FAP

The Facial Applicator, FAP, is made of:

1.Coil

2.A layer of hypoallergenic adhesive tape; over the coil

3.The assembly consisting of the coil and adhesive tape is covered with fabric material (different colours) woven from polyester, polyamide and Carbon. This fabric is hypoallergenic and has an antimicrobial treatment to maintain freshness, reducing the opportunity for bacteria to grow and spread. Also, this fabric is woven of fibers with unique cross sections that create micro-channels. These micro-channels carry-or “wick”-moisture away from skin. This fabric is lint free, and release almost no lint or contaminating particles that can irritate the skin and infiltrate pores. Friction and skin abrasiveness are virtually eliminated.

4.Cable for connection to Electronic Stem Generator medical device.

The assembly is designed so that generates field lines in the area of the teeth at a distance of about 14-15 mm (representing the thickness of the cheek wall). The magnetic field pervades the dental arch and allows the proliferation cells of interest

8.2.3. Battery Charger, code: BCH

Works in linear mode, and charges the battery in a constant current/constant voltage (CC/CV) profile.

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8.2.4. Applicator Connector, code: ACN

Connection between Dental Applicator, DAP or Facial Applicator, FAP and the Electronic Stem Generator Device (Generator of Sinusoidal Signal Module), is done via a two-wire copper conductor levels with a jack male / female type Binder (Male/Father jack attached to generator module).

8.2.5. USB Service Connector, USBC

Special cable, USBC, is for connecting the Electronic Stem Generator to the PC/Laptop.

8.2.6. Protective hard case

All components are placed into PVC protective hard case with special compartments.

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8.3. Principle of operation

External sinusoidal electromagnetic fields penetrate the skin without resistance and have a regenerative effect on the damaged tissue. Current knowledge indicates these magnetic fields have a regulating effect on metabolism, cell growth, and cell differentiation. In addition, the ability of electromagnetic fields to activate the exchange of molecular messengers, such as calcium, and to improve oxygen supply and blood flow to the tissue, thereby stimulating cell metabolism is the subject of ongoing worldwide research programmes.

The cell as a communication center in the human body is dependent on its ability to serve as the receiver of the data received from the environment. The cells are sensitive to external fields, such as electromagnetic field; these fields transmit information that cells use them at the atomic level to coordinate physiological processes (WR Adey). Physicist Herbert Frölich found that cells oscillate or vibrate into group, which allows the formation of a communication network (Frölich oscillations).

Information travels almost instantaneously through the human body through the field. Frölich also established that the living matrix forming cells of the human body, form a crystal lattice in which the body becomes extremely sensitive to signals received from the environment.

The cell membrane is actually a lipid layer that separates the internal structures thereof, of the body. There are various ion concentrations, both inside and outside the cell, such as Na +, K + and Cl +, which has a positive or negative electrical charge.

Two major forces determine how the movement of ions into and out of the cell:

∙Chemical force and

∙Electrical force

Since the human body contains large amounts of water, it is expected that the interaction with the electromagnetic field is an important part of the process that determines the biological effects.

Many of the effects of electric and magnetic fields on biological systems are a result of ion transport from one place to another; ions attract water molecules which bind to the different modes (configurations) and various forces.

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8.4.Clinical benefits

∙Electro-medicine, or healing with electromagnetic field covers non-invasive therapy without side effects

∙Electromagnetic regeneration of gingival tissues, without pain

∙Special comfort for the patient

∙Easy to use

8.5.Performance characteristics

Using the Electronic Stem Generator in combination with Dental Applicator or Facial Applicator helps to reduce:

∙The healing and treatment time of related medical conditions

∙The treatment costs.

After using the Electronic Stem Generator in combination with a Facial Applicator, for both female and male patients, a rate of the cellular mass growth was identified with an average of 40% in the problematic detected areas. After the measurements, the results show a significant improvement of the skin, as well as wrinkle reduction, due to increase in DNA synthesis and in the production of collagen.

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9. INSTALLATION OF Electronic Stem Generator

Please do not unpack the Electronic Stem Generator package, do not install or adjust the device before reading the present chapter. If you have any questions regarding the installation / adjustment of the device, consult qualified personnel of ZIR IMPLANT SRL.

The user can contact ZIR IMPLANT SRL or its representative:

∙For assistance, if necessary, in the installation, use and maintenance of Electronic Stem Generator

∙To communicate an operation not previously taken into account

9.1.Unpacking

Carefully unpack the box and check its contents. The packaging has been specially designed to ensure optimum protection of Electronic Stem Generator components during transport; however, if a particular component is damaged or missing, do not use the; contact ZIR IMPLANT SRL. Save the original packaging for possible return of the Electronic Stem Generator, when unforeseen events occur that require service or repairs.

Inside the box you will find the following:

  Electronic Stem Generator, ESG   1 piece  
       
        
  Accessories      
        
  Dental Applicator, DAP   1 piece  
        
  Facial Applicator, FAP   1 piece  
        
  Battery Charger, BCH   1 piece  
        
  Applicator Connector, ACN   1 piece  
        
  USB service connector, USBC   1 piece  

9.2.Cleaning and decontamination of Electronic Stem Generator before

use

The Electronic Stem Generator and its accessories are supplied in non-sterile condition.

 WARNING: Some methods for decontamination of Electronic Stem Generator Device can lead to increased wear. Check the device and cables before use, for signs of wear.

 WARNING: Use of accessories or cables other than those supplied by ZIR IMPLANT SRL, can damage the Electronic Stem Generator.

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CAUTION: Examine the presence of defects in the power cable and components. In case of a fault, do not use the Electronic Stem Generator, until its replacement.

 WARNING: Do not allow ingress of water or detergent into the jacks for connecting the applicator.

To clean the device, use a cloth dampened with soapy water, 70% isopropyl alcohol and 10% chlorine bleach diluted in distilled water, phenolic germicidal agent Matar® (0.5 oz.: 1 gal. of deionized water) or chlorhexidine. You can also use normal household disinfectants and wipes. Matar® is trademark of their respective owner.

To clean the dental applicator, use effervescent tablets denture cleanser diluted in water (which contains Sodium bicarbonate and other ingredients), such as Fixaplus 56,®. Fixaplus 56 and COREGA 3® are trademarks of their respective owners.

∙Insert an effervescent tablet into a warm (not hot) water container in an amount sufficient to cover the dental applicator

∙Leave the dental applicator in the solution obtained for 3 minutes

∙Clean the dental applicator with the solution obtained using a soft toothbrush

∙Rinse the dental applicator under the jet of water.

∙The remaining solution is discarded immediately after use.

To clean the facial applicator, use a cloth dampened with soapy water, 70% isopropyl alcohol and 10% chlorine bleach diluted in distilled water, benzoic tincture, Betadine®, phenolic germicidal agent Matar® (0.5 oz.: 1 gal. of deionized water) or chlorhexidine. You can also use normal household disinfectants and wipes. Betadine® and Matar® are trademarks of their respective owners.

9.3. Charging the batteries

In the OFF mode connect the cable of the charger in the apparatus, and then connect the charger to an electrical socket. The muzzle for the charger cable is positioned in the right lateral side of the Electronic Stem Generator.

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Hold the charger in the socket until the battery is fully charged (40 min).

After charging the batteries to their full capacity, disconnect the charger from the apparatus and plug it out.

Only recyclable batteries recommended by the manufacturer are to be used. It is strictly forbidden to use regular batteries instead of the original battery provided.

9.4. Moving the Electronic Stem Generator

Electronic Stem Generator components are light, being portable; it can be located and conveniently positioned near the therapy area (for example, can be placed on a table).

Before moving Electronic Stem Generator, make sure the following conditions are

met:

∙The device is switched off

∙All accessories and cables are disconnected

∙If you place the Electronic Stem Generator on a table or other support, make sure they are fixed and not subject to shocks, vibrations or other uncontrolled motion.

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10.COMPUTER SPECIFICATIONS THE ESG_USB_Update

APPLICATION

It is advisable to dedicate a laptop to the program. It is advisable to only install the recommended software and to follow the ‘Installation’ instructions.

∙It is recommended to have an Intel Core CPU (Core 2 duo) with a speed over 2 GHz.

∙The Electronic Stem Generator has a USB port. You may be connected directly using a USB cable

∙The Operating Systems needed is ‘Windows XP’, ‘Windows 7’ ‘Windows Vista’, ‘Windows 10’

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11.INSTALLATION & ACTIVATION OF ESG_USB_Update

APPLICATION

11.1. Installation/Activation of ESG_USB_Update Application

In order to provide a more professional service to our customers we are now able to offer 24 hour internet activation. Please follow the instructions below and if you have any difficulties please contact your broker for assistance.

These instructions are for users to activate their own software online. If you do not have internet access please contact your broker.

A.You will be able to pay with PayPal, either with your own PayPal account or your credit card.

1.After you pay online for therapy hours (see 11.2.), you will be redirected to the page www.stemgenerator.eu where you can view your order status and receive the download link for the client application.

2.Click the received link to download the ESG_USB_Update application

3.Run the ESG_USB_Update, running the downloaded application according to point 1.

These instructions are for users who want to activate the software by phone (Call center).

B. You will be able to pay by payment order or directly into bank account.

1.After you pay by payment order or directly into bank account, for therapy hours (after receiving a price offer and payment account by phone from our broker), you will be redirected to the page www.stemgenerator.eu where you can see the download link for the application.

2.Click the received link to download the ESG_USB_Update application

3.Run the ESG_USB_Update, running the downloaded application according to point 1.

The ESG_USB_Update startup screen without a device connected to your PC will show you in the following screen:

11.2. Loading of therapy hours

1.Connect the Electronic Stem Generator to the computer using the USB service connector, type USB-miniUSB.

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2.Press ON/OFF button (ON position) and start the device. On computer screen will appear the following window:

3.Select green/blue button to connect the device to ESG_USB_Update application. On screen will appear next windows with following information:

∙The firmware version of the ESG device

∙SN – physical serial number of this device

∙A serial number consisting of a group of 2 numbers separated by the character “-” is displayed, a number that will change after each treatment period update – this number must:

-Introduced in the appropriate field within the online page, if method A is used to update treatment hours and according to which another serial number will be generated as a result of online checks

-Communicated to the Call center operator or to our broker with whom the discussion was held to obtain a price offer and the bank account to which the amount needed to buy the treatment hours was transferred. The Call Center operator, after making the above-mentioned payment validity checks, according to this serial number, will return another number to the client with which he can activate the purchased hours on the device

∙In the empty boxes next to the text “Enter the code” the two groups of numbers will be filled in:

-Received from the online page (if it was chosen online update method)

-Received from the Call Center operator if it was chosen phone update method (Call Center)

∙After entering the two groups of numbers, press the “Activate”

4.After pressing the button, the following confirmation window is activated:

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And the following message will be displayed on your device screen:

5.To close the ESG_USB_Update application, tap the blue arrow then restart the device to update the treatment hours

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11.2.1. Online activation of therapy hours

In order to provide a more professional service to our customers we are now able to offer 24-hour internet activation of therapy hours. Please follow the instructions below and if you have any difficulties please contact you broker for assistance.

These instructions are for users to activate their own therapy hours online. If you do not have internet access, please contact your broker.

You will be able to pay with your credit card.

1.Visit the website: www.stemgenerator.eu

2.Click ‘Buy’ on top menu

3.Select ‘100 hours’ package’ if you want to load another 100 hours of therapy or KIT

SYSTEM GENERATOR if you want to buy an Electronic Stem Generator medical device

4.Please click on „Finalize the order”.

5.It requires a valid CIF to ensure there is a legal entity, please insert CIF No.

6.Connect the Electronic Stem Generator to PC and run ESG_USB_Update application. The application will display the serial number needed to update the treatment hours. Insert this number

7.Insert the serial number of the Electronic Stem Generator device that you have, the serial number provided by the ESG_USB_Update application to generate the activation code hours of treatment

8.Insert billing data (e-mail, phone)

9.There are two options of paying the activation fee:

∙Through a credit or debit card. To do so, please fill in the form and click on

„Review order and Continue”. You will receive by e-mail and SMS the recharge code

∙Through a Payment Order (when we have the confirmation of payment from the bank, we will send to you the recharge code by code by SMS

10.You will receive by e-mail your recharge code

11.After receiving the recharge code, please insert it in the ESG_USB_Update application and click on “Activate”.

12.After the device is restarted, treatment hours will be updated

11.2.2.Phone activation (Call Center) of therapy hours

In order to provide a more professional service to our customers we are now able to offer phone activation of therapy hours (Call Center). Please follow the instructions below and if you have any difficulties please contact you broker for assistance.

These instructions are for users to activate their own therapy hours by phone. You will be able to pay with your credit card.

1.Contact the Call Center at the specified phone number or contact your broker

2.Obtain a price offer from our broker or Call Center operator for the number of hours that you need, obtain at the same time the most convenient and quick way to pay and verify your payment

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3.After making the payment as directed by your Call Center operator or our broker, you need to connect the Electronic Stem Generator to your computer and run the ESG_USB_Update application. The application will display the serial number needed to update the treatment hours. Communicate this number to the Call Center operator or to our broker.

4.After the operator makes the payment checks, it will generate an activation code for the number of treatment hours that you have selected, which will be communicated to you.

5.You will receive by e-mail your recharge code

6.After receiving the recharge code, please insert it in the ESG_USB_Update application and click on “Activate”.

7.After the device is restarted, treatment hours will be updated

12.NECESSARY PROGRAMS FOR UPTADING OF THERAPY HOURS

This page details programs you need to have on your computer.

1.Necessary:

a.Internet Explorer 4 or later Web browser. This program is necessary to go through the Online Activation process.

b.The ESG_USB_Update application – the application through which the treatment hours are updated in the Electronic Stem Generator medical device (Note: this application works on any newer operating system than Windows XP)

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13. USB CABLE INSTALLATION

Note that the MAXIMUM recommended length of a USB cable is 2 meters (6 feet 7 inches). An USB cable longer than this will most likely reduce the communication between the operating laptop and the Electronic Stem Generator. Used cable is USB- miniUSB type.

1.Plug in the USB cable into PC/Laptop after that into Electronic Stem Generator (the Generator of Sinusoidal Signal Module must be switched on point).

2.The ‘Hardware installation wizard’ wills advice you of the new hardware and its dialogue box as follow:

3.After a short period of time, a new notification message announces that the device is of the USB Human Interface Device type and that once detected and classified, it is ready for use.

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14.OPERATING INSTRUCTIONS

14.1.Preparing for use

Before using the Electronic Stem Generator, make sure the following are met:

∙Cables are intact.

∙Case of device was cleaned and disinfected according to detailed instructions in this user manual.

∙The dental applicator was connected via binder plug, to the device

∙The batteries are charged

14.2.Putting into operation of Electronic Stem Generator

1.Turn the device ON by pressing the ON/OFF button for at least 3 seconds. Immediately after the device started, on the screen of the device there will appear an E- Doctor indicator and below the charging level of the chargers, the message ANSA will appear which means that the applicator is not connected to the Electronic Stem Generator yet. After connecting the applicator to the Electronic Stem Generator, the message ANSA will disappear, and this indicates the fact that there is an electromagnetic field set at the pre-established parameters given by the manufacturer.

From this moment on, the following can be seen on the screen

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∙The name E-Doctor

∙Date and time

∙Treatment credit (optional)

∙Time of current session

∙Battery charging level

2.The dental applicator is placed in the mouth of the patient, this is U-shaped, and is made so that at the end of its pole pieces to create an electromagnetic field that crosses the area of interest. In the top of its are placed two oval coils in parallel on both sides of the dental arch that generates an electromagnetic field with shape and amplitude imposed by the device. Between the pole of the loop (halfway between them) arises a constant amplitude sinusoidal electromagnetic field approx. 0,750 mT and constant frequency of 7.6920 Hz.

3.Apply the Facial Applicator as shown bellow:

4. Place the muzzle of the accessory (ANSA) in the superior side of the device

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5.Press the ON/OFF button to activate the Electronic Stem Generator and hold the device on for the entire treatment session.

The duration of a dental treatment is pre-established for a number of 100 time units (hours). Each session lasts for two hours. The sessions must take place daily (or with a maximum interval of two days in between sessions).

6.After finishing the session, turn of the device by pressing the ON/OFF button. After the therapy session ends, meaning at the moment the current session time is 00:00, the device will provide a sound signal

7.Prepare de device and the accessories for the following session by charging the battery of the device and cleansing the accessories, including the dental or facial applicator. After cleaning of the dental or facial applicator, it is kept in the self- adhesive bag in which was delivered.

15.SERVICE

15.1. Background

Electronic Stem Generator repairs should be performed only by qualified personnel that have been authorized by ZIR IMPLANT SRL; otherwise, ZIR IMPLANT SRL is not responsible for the safety, reliability and performance of the device.

15.2. Loss of warranty

Any guarantee or warranty claims to ZIR IMPLANT SRL are void if the user or an unauthorized person tries to repair the Electronic Stem Generator.

15.3. Description of defects

To enable ZIR IMPLANT SRL to conduct repairs in a short time, send the Electronic Stem Generator, accompanied by a detailed description of the defect; description should include the following:

∙Serial number of device

∙Accurate description of the defect

∙Date of delivery

∙Copy of invoice (for possible warranty)

∙Warranty of the Electronic Stem Generator

15.4.Handling of Electronic Stem Generator before shipping

To protect ZIR IMPLANT SRL personnel which performing repairs, before sending the Electronic Stem Generator for repair, cleaning and disinfecting it. ZIR IMPLANT SRL has the right to refuse repairs of Electronic Stem Generator, if they are dirty or contaminated, for safety reasons.

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15.5. Shipping

To send the defected Electronic Stem Generator to the producer/manufactured, please, use the original packaging; if this is not possible, wrap the device and all its removable parts in films of polyurethane foam and then into a carton box.

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16. Electronic Stem Generator SPECIFICATIONS

  Classification   
     
         
  Directive 93/42/EEC  Medical Device, IIa Class, Rule No. 9   
         
  EN 60601      
  Type of protection against electric shock  Class II  
  Degree of protection against electric shock  Type BF  
         
  In accordance with the method of sterilization or  NA  
  disinfection      
  According to the degree of protection required in the  NA  
  presence of flammable anesthetics mixed with air or      
  oxygen and nitric oxide      
  Operating mode  Continuous operation   
      
  EN 60529  IP40   
       
  Dimensions of Electronic Stem Generator (mm)   
      
  L x l x h   134 x 75 x 27   
     
  Weight Electronic Stem Generator (Kg)   
     
  Max. 0.247 Kg   
     
  Electrical characteristics   
     
  Voltage [power supply]   Internal electrical source: (3,7Vcc) -2 batteries (Li-  
      ion ;18650 3200mAh) at the electrical charging  
      network 100-240 V / 50-60 Hz by the means of the   
      adaptor only for the charging of the batteries   
     
  Power consumption   DC (1 A)   
    
  Dental therapy characteristics   
     
  Waveform   Sinusoidal   
     
  Frequency   7.6920 Hz   
     
  Magnetic induction   0.750 mT   
    
  Electrical protection   
     
  Electric stiffness   The device supports a voltage between the network   
      and the applicable parts of 4 KV for 1 minute  
      according to EN 60601-1.   
     
  Insulation Resistance   Min. 10 MΩ   
     
  The leakage current   Max. 10 μA, under normal conditions  
      Max. 50 μA, in single fault condition   
    
  Environmental conditions   
       
  Operating Temperature   15 – 30 0C   
       
  Transport and storage temperature   (– 25) – (+55) 0C   
       
  Humidity rated   30 – 80 % at 250 C, non-condensing   
       
      The Electronic Stem Generator device works in a  
  Other requirements   closed environment, away from direct sunlight   
       
      To minimize electrostatic discharge, is recommended   
      for wood surfaces, concrete or ceramic   
   
  Conditions for operation and maintenance   
     
  Average level of service request   6 cumulative hours / day   
     
  The normal duration of use   6 years  
          
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17. LABELING OF Electronic Stem Generator

LabelDescriptionLocation
 Identification label ofOn the back face of the
 Electronic Stem Generatorcase of the device

Labelling of accessories

Identification label of theOn the bag of the Dental
Dental ApplicatorApplicator

Identification label of the Facial Applicator

On the box of the Facial Applicator

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LabelDescriptionLocation
Identification label of theOn the cable of the Dental
Applicator connectorof Facial Applicator
Identification label of theOn the cable of the
Battery ChargerRecharging

Identification label of the USB On the USB cable service connector

Labelling of package

Identification label ofOn protective case and on
Electronic Stem Generatorcarton box
Device and its accessories 
package 

18. RECYCLING OF Electronic Stem Generator

The Electronic Stem Generator consists of components that are not biodegradable, eliminating them in the environment is not recommended.

Destruction of the Electronic Stem Generator and applicator is safe for humans, if it complies destruction mode, shown below.

At the end of the life of the Electronic Stem Generator, please go with it at recycling electrical and electronic equipment. Recycling itself is done by authorized economic operators, as required by law, taking into account that the device contains: capacitors

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 39 of 40

SC ZIR IMPLANT SRL

______________________________________________________________________________________

19 Razboieni street, Breaza, Prahova – Romania

Tel.: +40 722.66.07.66, E-mail: info@stemgenerator.eu

www.stemgenerator.eu

Electronic Stem Generator – User Manual

(containing polychlorinated biphenyls – PCB), circuit boards, components containing mercury (e.g. switches), plastics, components that contain ceramic fibers, etc.

No. 004.004-EN, Edition 1, Revision 4, November 2018Page 40 of 40