Bredent HELBO TheraLite Manual de usuario

PHOTODYNAMIC THERAPY

HELBO®

User Manual

HELBO®TheraLite Laser

and additional accessories for the antimicrobial Photodynamic therapy

Version 14 06/2017

S I N C E 1 9 7 4

PHOTODYNAMIC THERAPY

HELBO®User Manual for HELBO® TheraLite Laser

Table of contens

1. ANTIMICROBIAL PHOTODYNAMIC THERAPY (aPDT) 3

1.1. INTRODUCTION 3

1.2. COMPONENTS (AN OVERVIEW) 4

1.3. CLINICAL PROCEDURE (IN RED) 5

1.3.1. Periodontology 6

1.3.2. Endodontics 7

1.4. THE PHOTOBIOLOGICAL EFFECT 8

2. THE HELBO® THERALITE LASER: 9

2.1. PRODUCT DESCRIPTION AND PURPOSE 9

2.2. CONTROL ELEMENTS 10

2.3. APPLICATION 10

2.3.1. Contraindications / Side effects 11 11

2.4. HELBO® FIBRE OPTICS 12

2.4.1. HELBO® 3D Pocket Probe 13

2.4.2. HELBO® 2D Spot Probe 14

2.4.3. HELBO® 3D Endo Probe 15

2.5. START-UP 16

2.5.1. Batteries 16

2.5.2. Operating states / displays 17

2.5.3. Main switch 18

2.5.4. Button 18

2.6. MAINTENANCE / SERVICE 19

2.7. CLEANING 19

2.8. POWER SUPPLY 20

2.8.1. Changing the batteries 20

2.8.2. Battery storage 21

2.9. SAFETY INSTRUCTIONS / WARNING NOTICES 22

2.10. EMC (ELECTROMAGNETIC COMPATIBILITY) 24

2.11. TECHNICAL SAFETY CHECK in accordance with EN 62353 28

2.12. TECHNICAL DATA 29

2.13. CE MARKING 30

2.14. DISPOSAL 31

2.15. TROUBLESHOOTING 31

2.16. LASER EMERGENCY STOP 33

2.17. Warning signs / Information signs / General signs 34

2.18. GENERAL INFORMATION ABOUT LASER SAFETY 35

2.19. GUARANTEE 36

PHOTODYNAMIC THERAPY

HELBO®User Manual for HELBO® TheraLite Laser

Version 14 06/2017

1. ANTIMICROBIAL PHOTODYNAMIC THERAPY (aPDT)

1.1. INTRODUCTION

Antimicrobial photodynamic therapy represents a method of treating superﬁcial bacterial infections locally.

This therapy involves applying a dye (phenothiazine chloride) to the infected area after having mechanically

cleaned it. After an exposure time of at least 60 seconds, excess dye is rinsed away. This is followed by exposure

of the dyed, infected tissue to the HELBO® TheraLite Laser. The ﬁbre optic used depends on the area being treated.

The HELBO® 2D Spot Probe is used on larger areas, and includes a spacer to ensure that the power density necessary

for therapeutic purposes is maintained. It radiates divergent beams of light outwards and forwards.

The HELBO® 3D Pocket Probe is used to treat infected pockets, and the HELBO® 3D Endo Probe is designed for

use on infected root canals.

Staining the pathogenic bacteria with the dye and then exposing them to the laser results in targeted transfer

of the light energy to the ambient oxygen, converting it quantum-energetically into short-lived, antimicrobially

active singlet oxygen (= type II photodynamic reaction). The singlet oxygen’s oxidative effect breaks down both

the bacteria and the surrounding bioﬁlm matrix, which explains the source of aPDT’s targeted decontamination

effect on localised, superﬁcial infections. As such, using the HELBO® aPDT to remove pathogens alleviates the

body’s inﬂammatory reaction.

The 660-nm laser light also has a photobiological effect on the healthy cells of the tissue being treated, further

amplifying the therapy’s ability to reduce inﬂammation and promote wound healing.

For this reason, the HELBO® TheraLite Laser is also suitable for use in low-level laser therapy (LLLT), i.e., for use

without dye in order to promote wound healing. Known effects of 660-nm LLLT on tissue include pain relief;

promotion of epithelialisation, collagen synthesis and blood vessel formation; oedema reduction; bruise healing;

and scar tissue conversion.

PHOTODYNAMIC THERAPY

HELBO®User Manual for HELBO® TheraLite Laser

1.2. COMPONENTS (an overview)

HELBO® TheraLite Laser

• Diode laser with integrated power control and innovative ﬁbre optics

• Exceptional light power allows short treatment times; mains-power independent for greater mobility (battery

mode)

• Small, light and ergonomically perfect for fatigue-free operation

HELBO® 3D Pocket Probe: for infected pockets

• Three-dimensional, uniform, lateral exposure

• Angled for optimum access to all areas, including distal areas

• Sterile disposable product to prevent spread of bacteria

• Power density > 60mW/cm2

HELBO® 3D Endo Probe: for infected root canals

• Three-dimensional, uniform, lateral exposure

• Increased apical radiation

• More ﬂexible ﬁbre optic for effective use in root canals

• Greater probe rigidity

• Sterile disposable product to prevent spread of bacteria

• Power density > 55mW/cm2

HELBO® 2D Spot Probe: for infected surfaces

• Concentrated two-dimensional exposure

• Spacer and active ﬁeld marker ensures optimum power density

• Sterile disposable product to prevent spread of bacteria

• Power density > 100mW/cm2

HELBO® Endo Seal

• Light-curing one-component lacquer for dentine sealing

HELBO® T-Controller: (T = Time &Therapy Control)

• Aesthetic

• Functional

• Simple control of

relevant performance parameters for

assured therapy success

• Optimum time &therapy control

HELBO® CHARGER SET

• Microcontroller-controlled charging function

• Automatic refreshing program to care for your battery

• High-end NiMH batteries with 800 mAh typical

PHOTODYNAMIC THERAPY

HELBO®User Manual for HELBO® TheraLite Laser

Version 14 06/2017

1.3. CLINICAL PROCEDURE (in red)

 Control of relevant process parameters with the HELBO® T-Controller

Brief instructions Activity

(at device)

Display Acoustic

signal

Therapy stage Next stage

Initial situation:

Rinse mouth 2x

None None None Rinse patient’s mouth twice for

approx. 20 sec. with sufﬁcient

water / remove saliva and blood

from the areas to be treated

Switch main switch to „on“

Main switch in “on“

position

Switch main

switch to „on“

Tooth ﬁelds 1-8 ﬂash (red) None Select corresponding tooth ﬁeld

according to the number of teeth

to be treated

Press corresponding tooth

ﬁeld according to the num-

ber of teeth to be treated

Pressing the correct

tooth ﬁeld, application

of phenothiazine

chloride dye

Press corre-

sponding tooth

ﬁeld according

to the number

of teeth to be

treated

Tooth ﬁelds according to the

number of teeth to be treated

are permanently lit

None Dye application and distribution

(if necessary) using the air

blower on the multi-functional

syringe to ensure thin, uniform

coverage of the entire surface

Monitoring dye exposure

time by pressing the Go/

Break key

Pressing the Go/Break

key. Phenothiazine

chloride dye exposure

time: 60 -180 sec.

Press Go/Break

button

Tooth ﬁelds according to the

number of teeth to be treated

are permanently lit / “photosen-

sitizer” display (blue) is perma-

nently lit for 60 sec. and ﬂashes

slowly for another 120 sec.

Beep Dye exposure (60-180 sec.) Rinsing using the multi-

functional syringe and

suctioning off excess dye

Rinsing and suction of

excess phenothiazine

chloride dye

None “Photosensitizer” display (blue)

ﬂashes rapidly

None Rinsing using the multi-function-

al syringe (including in the

pocket!) and suctioning off

excess dye

Press Go/Break button once

more; exposure of ﬁrst tooth

with the HELBO® TheraLite

Laser for 60 sec.

Press Go/Break button

once more, exposure

with HELBO® TheraLite

Laser: 60 sec. per tooth/

per cm2

Press Go/Break

button

Tooth ﬁeld “1” ﬂashes, tooth

ﬁelds of the teeth not yet treat-

ed are permanently lit, 60 sec.

display indicates exposure time

in 10 sec. intervals

Beep Exposure of ﬁrst tooth with

the HELBO® TheraLite Laser for

60 sec.

Exposure of the remaining

teeth with the HELBO®

TheraLite Laser for 60 sec.

each

Exposure of the remain-

ing teeth: 60 sec. per

tooth/per cm2

None Tooth ﬁeld “2” (3-8) ﬂashes,

tooth ﬁelds still requiring treat-

ment are permanently lit, 60

sec. display indicates exposure

time in 10 sec. intervals, tooth

ﬁelds of teeth already treated

are not lit

Beep

(every

10 sec.

after each

additional

tooth)

Exposure of the remaining teeth

with the HELBO® TheraLite Laser

for 60 sec. per tooth

End of therapy after last

sound is heard (all tooth

ﬁelds 1-8 ﬂash)

Conclusion of therapy:

Rinse

Turn off device

by pressing

„on/off“ button

None None Thoroughly rinse patient’s mouth None

Other func-

tions:

Press Go/Break

button during

treatment

Tooth ﬁelds still to be treated

are permanently lit / 60 sec.

display ﬂashes

None

Press RESET

button during

treatment

Starting point: All tooth ﬁelds

ﬂash

„Check Bat-

tery“ warning

light

Lights up early when battery

power is low => change battery

None

PHOTODYNAMIC THERAPY

HELBO®User Manual for HELBO® TheraLite Laser

1Perform professional dental cleaning.

Important: Removing concrement from the tooth/root surface ensures better

access to the bioﬁlm.

The aPDT procedure is performed immediately or no more than 1-2 days

after cleaning (aPDT is recommended on the following day in particular

if there is excessive bleeding after cleaning).

1.3.1. Periodontology

2Apply phenothiazine chloride dye starting at the fundus of the pocket

Important: Any pockets of air down inside the dental pocket will prevent the

phenothiazine chloride dye from reaching all the bacteria.

3Leave the phenothiazine chloride dye on for at least one minute -- three minutes

when treating pockets > 6 mm or persistent, refractory infections.

Important: Only bacteria stained blue will be killed.

4Rinse pocket thoroughly with H2O– remove excess dye, including at the bottom

of the pocket (use suitable rinsing device).

Important: Apply a very thin layer of phenothiazine chloride dye so that not too

much light will be absorbed and the laser light has its full desired

effect.

5Circular exposure for approx. 1 minute (in 6 areas) per tooth/cm².

Important: Only sufﬁciently exposed bacteria are killed.

Ensure proper condition of optics and preferably recharge

batteries daily.

PHOTODYNAMIC THERAPY

HELBO®User Manual for HELBO® TheraLite Laser

Version 14 06/2017

1Prepare the tooth in the conventional manner forendodontic purposes.

Important: Dental dam recommended; preparation to ISO 45 is best (manually or

by machine), rinse afterwards (H2O), then dry with paper tips, which are

then left in place in the canals.

1.3.2. Endodontics

2Apply HELBO® Endo Seal all over the crown area and allow light-curing to take place.

Important: Diffusing dye can cause permanent discolouration, so protecting this

area is essential.

3Remove paper tips and apply phenothiazine chloride dye, working from apical

to coronal.

Important: This prevents air pockets so that the phenothiazine chloride dye

reaches all bacteria; when treating small areas (< ISO45), use a suitable

instrument (e.g., Lentulo) to transfer the dye apically.

4Leave the phenothiazine chloride dye for at least one minute.

Important: Only bacteria stained blue will be killed.

5Remove any excess phenothiazine chloride dye -- preferably by rinsing with

H2O and drying thoroughly using paper points.

Important: Excess dye will absorb light energy and may prevent correct light

application; root canals must be completely dry.

6Expose for 1 minute per canal: Strive for contact exposure – as close as possible to

the stained bacteria, including in an apical direction.

Important: Only adequately exposed bacteria are killed.

Ensure proper condition of optics and preferably recharge

batteries daily.

7Seal canals and mechanically remove (ﬁnisher!) any dye residue in the crown area.

Important: Thanks to signiﬁcant reduction in the number of bacteria, deﬁnitive

obturation can be performed immediately.

PHOTODYNAMIC THERAPY

HELBO®User Manual for HELBO® TheraLite Laser

1.4. THE PHOTOBIOLOGICAL EFFECT

What is achieved by the photobiological effect?

• Inﬂammation is suppressed

• Wounds heal faster

• Pain is reduced

How does the photobiological effect work?

• The mitochondria in the cells are stimulated, the inhibiting inﬂuences on the metabolism and the energy

supply are reduced.

Why does the photobiological effect work?

• The radiation with blue to red laser light (wavelength 380 nm to 700 nm) stimulates the synthesis from ADP

to ATP through oxidative phosphorylation.

The so-called low-level laser therapy (and thus the photobiological effect) is a regulation therapy. It increases the

circulation where required by the respective indication and conversely inhibits it for those indications where it is not

required. The same regulatory behaviour is effected by the laser treatment in the case of the immune reaction too.

PHOTODYNAMIC THERAPY

HELBO®User Manual for HELBO® TheraLite Laser

Version 14 06/2017

2. The HELBO® TheraLite Laser

2.1. PRODUCT DESCRIPTION AND PURPOSE

The HELBO® TheraLite Laser is an

• active,

• electrical,

• therapeutic

• hand-held

medical device intended for temporary use.

The HELBO® TheraLite Laser is designed for exposing tissue surfaces to laser light with a wavelength of 660 nm

at a ﬁxed area dose. The laser light is not transferred to the desired point via the laser device itself -- this happens

only in combination with the ﬁbre optics intended for this purpose (HELBO® 3D Pocket Probe, HELBO® 2D Spot Probe

and HELBO® 3D Endo Probe).

The HELBO® TheraLite Laser is a battery-powered, hand-held, mobile Class 2M laser device. The front part of

the HELBO® TheraLite Laser has a ﬁbre optic connector. Three different coloured LEDs near the button indicate

the device’s operational status. The laser is equipped with a number of safety features, including a time delay, a

main switch, reverse polarity protection for batteries in the contact cap, a battery warning function, and a laser

beam locking apparatus.

The HELBO® TheraLite Laser emits the monochromatic, coherent light in the red spectral range necessary for

antimicrobial photodynamic therapy (aPDT) and low-energy laser therapy (LLLT). It is not possible to use the

HELBO® TheraLite Laser without ﬁbre optics, as the device will not emit light without them. The ﬁbre optics have

a maximum power of 40 mW and emit light in the visible range at wavelengths of 660 to 667 nm

PHOTODYNAMIC THERAPY

HELBO®User Manual for HELBO® TheraLite Laser

2.2. CONTROL ELEMENTS

2.3. APPLICATION

The HELBO® TheraLite Laser has been specially developed and manufactured for use in context of antimicrobial

photodynamic therapy and low-level laser therapy.

It may only be used in combination with the HELBO® ﬁbre optics specially designed for it. These light guides are

used for different purposes and each have speciﬁc indications.

The treating physician or dentist is solely responsible for selecting patients to receive this treatment.

Potential dental indications include:

• Periodontal disease

• Peri-implantitis

• Endodontitis

• Alveolar disinfection

• Bone necrosis

• Disorders of the skin or mucous membranes

• Tooth decay

Combination display:

• Laser ready –

• Emissions –

• Battery warning indicator

The following are located on the rear side:

• Laser warning label

• Indication of the laser class

• Serial number and technical data

• CE mark

• Manufacturer’s label

Start button

Luer connection for HELBO® ﬁbre optics

Main switch

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