HAGER WERKEN LaserHF standard User manual

Dental Combination Device
Laser plus radio frequency
User Manual
LaserHF®

LaserHF®„standard“

User Manual
Page 4 Advices and warranty
Page 5 Comments to content/scope of delivery
Page 6 Laser light - mode of action
Page 7 Laser protection and safety regulations
Page 8 Radio frequency (HF) – mode of action
Page 9 Technical data
Page 10 Caution and safety regulations (i.e. safety goggles)
Page 12 Operator‘s ordinance
Page 13 Preparation to start the device/labelling
Page 14 Device description/dual user conception
Page 16 Start the unit
Page 21 Selection of the correct radio frequency (HF) mode
Page 22 Set appropriate intensity
Page 23 HF (radio frequency) CUT MODE
Page 24 HF (radio frequency) COAG MODE
Page 25 HF (radio frequency) BIPOLAR MODE
Page 27 LASER MODE
Page 30 PDT/LLLT MODE
Page 31 Processing guidance for LaserHF handpieces, acc. EN ISO 17664:2004
Page 31 Troubleshooting
Page 31 Environmental protection guideline
Page 32 Catalog of error messages
Page 34 Clinical applications laser
Page 35 Clinical applications radio frequency (HF)
Index
This user manual contains information, which are copyright protected and are not allowed to be partly or completely copied
or stored on microfilm or electronic items and should not be distributed without the written permission by
Hager &Werken GmbH & Co.KG.
If errors occur or if contents of this user manual are not clearly formulated, please inform Hager & Werken GmbH & Co.KG.
Copyright © 2022 - Hager & Werken GmbH & Co.KG

User Manual
Please carefully read this user manual!
Read this user manual carefully, and familarize yourself with the use and functions of the unit and all accessories, before you start
using the device.
Should you fail to follow the instructions, the following problems may occur:
• Serious injuries to the patient
• Serious injuries to the operator or to the service personal
• Damage or malfunction of the unit or of the accessories
Intended purpose
The LaserHF device is used for cutting, coagulating, removal (laser and radio frequency surgical) and irradiation (laser therapeu-
tic, photodynamic therapy, low level laser therapy, whitening „bleaching“) of soft tissue in dentistry. No essential performance
features according to EN 60601-1 are assigned to the device.
Areas of application
The LaserHF device is intended for the use in professional dentistry, and must only be operated by personnel skilled or trained in
dental laser and radio frequency surgery.
Modifications
The manufacturer has the right to modify the appearance and technical data because of new product developments.
The marks: “ WA R N I NG “, “ATT ENTION“ and “REMARK“ contain important Tips.
Responsibility of manufacturer
Warranty and liability by Hager &Werken GmbH & Co KG is given, if:
• installation and start of operation is done by own personal or by personal authorized by the manufacturer
• installation and safety measures comply with national norms and regulations
• the unit is used in accordance with the user manual
• the unit is used under supervision of a LSO (Laser Safety Officer)
• no changes are made to the device and its accessories, unless authorized by the manufacturer.
Warranty
The LaserHF unit has a legal warranty of 12 months.
4
HAGER & WERKEN GmbH & Co. KG
Ackerstraße 1
47269 Duisburg, Germany
T [phone]
F [phone]
[e-mail]
www.hagerwerken.de

User Manual
5
Explanations to the user manual
Important directives, especially for technical safety and security, are mentioned:
WARNING DANGER
The safety of the patient, the operator, or a third person is in risk. If information is not consi-
dered, persons can be in danger.
ATTENTION
This information advices to special service procedures or caution measures, which must be
considered to avoid damage to the unit.
REMARK
This is general and special information to clarify important and helpful instructions.
Scope of Delivery
LaserHF - REF 452 462
LaserHF bare fiber AS 200/240 REF 452 463
LaserHF bare fiber AS 320/385 REF 452 464
LaserHF handpiece 8W Laser Red REF 452 465
LaserHF handpiece PDT Laser Orange REF 452 466
Electrodes:
HF-CUT electrode No. 1, yellow shaft REF 452 403
HF-CUT electrode No. 2, yellow shaft REF 452 404
HF-CUT electrode No. 15, yellow shaft REF 452 407
HF-CUT electrode No. 13, yellow shaft REF 452 411
HF-COAG electrode No. 31 , blue shaft REF 452 415
Hf-COAG electrode No. 33 , blue shaft REF 452 416
HF handpiece yellow 1,50 m REF 452 423
HF handpiece blue 1,50 m REF 452 425
Neutral electrode REF 452 421
Hager iSpec laser protective glasses, yellow, 808-1064 nm REF 355 630
Hager iSpec laser protective glasses, over glasses, yellow, 808-1064 nm REF 355 631
Hager iSpec laser protective glasses, over glasses, blue 650-660 nm REF 355 632
Hager iSpec laser protective glasses, for patients REF 355 633
Plug door contact/interlock
Foot pedal (Steute MKF 1S-MED-AP SK12 IP protection X8)
User manual / Medical product journal
(Bipolar forceps optional)

User Manual
Laser light and radio frequency energy can both be used to convert electromagnetic radiation into heat. The basic tissue interac-
tion of laser and radio frequency applications are nearly the same, especially compared in their clinical appearance. Additional to
heat effects the laser radiation can be used at low power to perform therapeutic and photoactive applications.
Interaction of laser light
THERMAL INTERACTION
If laser light is transmitted by thin glass fibers an extreme power density can be cre-
ated at the fiber output surface. Tissue with mainly water content strongly absorbs
the laser radiation and creates heat. The water will be evaporated in shortest time,
biological material then will be vaporized – this effect can be used to coagulate and
cut tissue as well as to kill pathogen germs. For the most effective way it is necessary
to use a wavelength, which is well absorbed in water – the LaserHF unit uses a wave-
length of 975 nm, in a maximum of absorption.
THERAPEUTIC INTERACTION / LLLT
Laser light does not only perform tissue vaporization or coagulation of blood vessels, more than that it can stimulate cells in a
therapeutic sense. In the LLLT (Low Level Laser Therapy) the laser power densities are less than in thermal applications, much
smaller than 1 W/cm2. Appropriate wavelengths can be found in the red spectral range from 630 – 680 nm, the LaserHF unit uses
660 nm.
LLLT applications are wound healing (stimulation of cell growth), pain treatment (release of nerve irritation) and the treatment of
eczema (stimulation of lymphatic vessels).
PDT
As an integral part of the LaserHF device, a second laser source with a red wavelength is added for PDT (Photo Dynamic Therapy).
Using an appropriate substance like Toluidine-Blue, the bacteria in tooth pockets, root canals and caries cavities can be stained –
the color molecules will be accumulated in the cell walls of micro organisms, and then afterwards irradiated with red laser light.
Due to the laser irradiation oxygen radicals are generated which mortify those cells. The exact way it works can be found in the
user manual for PDT.
6

User Manual
WARNING DANGER
• When separating the laser fiber from the laser device, always cover the connections with the protective
caps provided.
• This laser device must not be used in the vicinity of flammable materials or in areas where there is a risk
of explosion.
• Materials enriched with oxygen such as cotton wool can catch fire due to the high temperatures of the
laser light.
• All flammable solutions that are used to clean and disinfect the LaserHF must have evaporated before
the device is used.
• Be aware of the risk of fire from flammable gases.
• The laser vapor contains tissue particles. Bear the risk of infection in mind and wear a mask at all times.
Attention
Take into account the maximum bending radius of the light guide:
• Short-term (during treatment): 100 x the radius of the light guide
• Long term (during storage) 600 x the radius of the light guide
• Never bend or jam the light guide, it could break.
• The light guide can get damaged if strongly bent within the handpiece or if improperly guided. This can
pose health risks to patients, dentists and assistants.
• Never pull on the light guide.
Further information on laser fibers can be found in the separate UMN for laser fibers.
NOHD (eye safety distance) approx. 1.5 m when the unprotected eye is irradiated for ten seconds (passage
of the light guide NA = 0.22).
WARNING DANGER
Laser radiation is very dangerous for the highly sensitive, unprotected eye. Therefore, when using laser ra-
diation, both the staff and the patient must wear the safety glasses included in the scope of delivery.
When using the 975 nm laser (red handpiece), the user(s) must wear the glasses with a yellow filter and the
patient must wear the full protective glasses.
When using the PDF laser (orange handpiece), the user(s) must wear the glasses with a blue filter and the
patient must wear the full protective glasses.
Specifications of the eye protection: Protective filter yellow: 808 - 1064 nm D LB6 + IR LB8 + M LB10
Protective filter blue: 665 - <670 DIR LB4
Patient safety glasses: >315 - 1400 D LB6 + IR LB9 + M LB7
The explanation of the specification is included with every pair of glasses.
Laser protection and safety regulations in the dental practice
7

8
Interaction of radio frequency (HF)
If radio frequency is guided through very thin metal electrodes, a very large electro-magnetic power density is created in the tissue
layer. The water is abruptly heated up in these cells which leads to coagulation and rupture, respectively.
THERMAL INTERACTION (MONOPOLAR)
CUTTING (CUT) / COAGULATION (COAG)
At monopolar cutting the radio frequency current is led from the device
via a work electrode and a large neutral electrode back to the device. The
current density at the treatment point is very high, but it is very low at
the neutral electrode.
The electric current density leads to a fast and strong heating in tissue,
which can be used for cutting and coagulation.
THERMAL INTERACTION (BIPOLAR)
At bipolar application the current is going from one side of an instru-
ment (i.e. forceps) to the other side of the device. The current flows into
the tissue over one side of the instrument and back to the HF surgical
device over the other side of the instrument.
The advantage of this technology is to apply the current in an exact de-
fined area, so it can be used for selective coagulation and closing of small
vessels.
User Manual

9
User Manual
Technical Data
Laser
Wavelength + Power Diode Laser: 975 nm ± 10 nm, 8 Watt, Lk 4
Pulse Of Duration: Mode: cw and pulsed: 5, 25, 50, 100 Ms
Wavelength + Power Pdt/Lllt: 660 nm ± 5 nm, cw, max. 100 mw, Lk 3b
Wavelength + Power Pilot Laser: 660 nm, 2 mw, Lk1
Hf
Frequency + Power: Monopolar 2.2MHz max. 50 W at 1000 ohm load
Bipolar 2.2 MHz max. 45 W at 250 ohm load
Coagulation 2.2MHz max. 45 W at 1000 ohm load
Permanently /pulsed
Operating temperature +10 °C - +40 °C
Storage temperature -20 °C - +60 °C
Air humidity When in operation: <85 %, non-condensing
When not in operation: < 90 %, non-condensing
Air pressure When not in operation: 500 hPa - 1080 hPa
When in operation: 700 hPa - 1080 hPa
Power supply 230 V Ac, 50/60 Hz
Unplug the power plug for an all-pole disconnection of the device
Power consumption Max. 1.5 A
Power fuse 2 x TI. 6 AH
Classification medical device Class IIb
Duty cycle Continuous Operation 1 Min., Interval Time 4 Min.
Applicators Fiber with SMA
200 µ m – endodontics
320 µm – periodontics, implantology
320 µm – pdt, Lllt
Autoclavable
Handpiece Autoclavable (only standard version)
Safety According to DIN EN ISO DIN EN ISO 60601-1
Electromagnetic Compatibility According to DIN EN ISO 60601-1-2
Safety Hf Surgery Equipment According to DIN EN ISO 60601-2-2
Safety Laser According to DIN EN ISO 60601-2-22
HF handpiece cable, yellow Length 1.50m
HF handpiece cable, blue Length1.50m
HF Bipolar cable, optional accessory Length 1.50m
HF neutral electrode line Length 1.50m
Foot switch cable Length 2.50m
Cable for door contact switch Unlimited
Power cable Length 2.50m
Cables

2. The NEUTRAL ELECTRODE should be in close contact with a correspondingly prepared suitable area of the PATIENT‘S
body with its entire surface, as defined by the PRODUCER.
3. The PATIENT should not get in touch with any metal parts that are grounded or have a significant earth capacitance
(e.g. operating table supports, etc.).
4. Skin-to-skin contacts (e.g. between the arms and the body of the PATIENT) should be avoided, e.g. by inserting dry gauze. The
cable leading to the LaserHF device should neither touch the patient nor any other wires. Instruments which are temporarily
not in use during the treatment have to be kept away from the patient, e.g. on the instrument table.
5. The output power should be set as low as possible for the corresponding purpose.
6. An obviously low output value or functional failure of the LaserHF device in usual operation can be caused by insufficient
contact of the NEUTRAL ELECTRODE or insufficient contact in its connections. In such case, the contact of the NEUTRAL
ELECTRODE and its connections should be checked before setting a higher output power.
7. The use of ignitable anesthetics or combustible gases like nitrous oxide (N20) and oxygen should be avoided if a surgical inter-
vention is executed in the head area, unless these substances are aspirated. If possible, non-ignitable ingredients should be used
for cleaning and disinfection. Ignitable ingredients used as cleaning and disinfection agents or as solvents for adhesives should
have evaporated before the use of the HF Surgery.
8. For patients with pacemakers or other active implants, there is a potential DANGER of disturbance of the pacemaker function
or damage to the pacemaker. In case of doubt, consult an expert.
9. The accessories must have a minimum accessory reference voltage of 500 V. Only use the original accessories contained in the
scope of delivery and offered by the manufacturer to achieve maximum safety for the patient and the dentist. The characteri-
stics of the applied parts and wires are adapted to the output power and output voltage of the device, so that a safe operation is
ensured for all operation modes and settings.
10. The device must be disconnected from the power supply during cleaning.
The LaserHF device may only be put into operation after the instructions have been given by the operator and in compliance with
the prescriptions and safety provisions.
1. A minimum distance of apprx. 20 cm from any wall must be kept at all times during operation.
Protection and safety provisions in the dental office for the use of radio frequency (HF) surgery of
the LaserHF device
WA R N I NG
The device must only be connected to a power supply with an earth wire in order to avoid the risk of an
electric shock.
Check the cables, handpiece and electrodes as well as the foot pedal on visible damage before
starting up the LaserHF device. Instruments with brittle or faulty insulation must not be used
as they pose a danger of injury.
When operating the LaserHF device, unpredictable malfunctions might occur that could cause un-
wanted output power increase.
User Manual
10

11
11. Service and maintenance tasks must only be executed by authorized specialized personnel.
12. The radiation emitted by the LaserHF device during operation can interfere with the functionality of other electric devices.
Computers, laptops and mobile phones should be kept away from the LaserHF device. Data on computers and laptops should
be saved beforehand.
13. If any safety provisions and operating instructions contained in this manual are violated, any warranty and liability of the
manufacturer is cancelled.
14. In operating rooms, the device must only be used with pedal switches with AP labeling.
User Manual

12
Operator regulation
According to Councel Directive 93/42/EEC, the device is classified as medical device unit class IIb. Thus all directions of the Eu-
ropean operator regulation apply, including those for devices according to Appendix I.
§ 5: Operation and execution
§ 6: Technical controls
§ 7: Medical product documentation
Technical controls:
The user is committed to perform technical controls on a regualar basis, in accordance with the following specifications:
Period: Every 12 months, starting with date of delivery and after each repair.
Covering:
Visual check of the unit and accessories
Check according to IEC 62353 (VDE 0751)
- Protective earth resistance
- Alternate leakage current
- Alternate patient leakage current
Function check
- Main switch
- Touch display
- Receptacles
- Emergency switch
Measurement of radio frequency (HF) output power at a load of 1 kΩ:
- Output CUT (50W)
- Output COAG (45W)
- Output (45W)
Measurement of laser output power (calibration of the laser output)
- Output PDT (10mW and 100mW)
- Output Laser (100mW and 8W)
All results of measurements must be documented according to IEC 62353 (VDE 0751) concerning the first measured values. If
defects occur during the controls, the user is responsible to initiate repair.
User Manual
Legend (for adjacent label)
Attention laser
Manufacturer
CE mark
Foot control
Door contact switch
Follow the instructions for use
Disposal
Defibrillation-protected applied part
Non-iosing radiation
Date of manufacture

13
Preparation to start the device
• In order to avoid condensed water, make sure the unit has been at room temperature for quite some time (e. g. storage room or
transportation for at least 2 hours) before you use it.
• It is important that the ventilation slots are not covered and that the unit has a minimum distance to walls and
other units of 20 cm.
Safety information!
Invisible laser radiation - laser class 4
Avoid damage of eye and skin by direct or indirect irradiation.
Start up
• All national safety aspects must be fulfilled.
• Connect interlock output with door contact or use a dummy connector.
• Connect foot switch to unit.
• Connect power supply cable first to the unit, then to house power output.
• Connect fiber optic cable to the laser handpieces: open fixture, carefully feed the fibercable from the rear through the
handpiece and into the fixture, then close fixture. Insert the plug into the socket making sure to match the color of the
handpiece. Screw hand-tightwithout using a tool.
• Open the fixture at radio frequency (HF) handpieces and insert appropriate electrodes. Close fixture.
• Put the handpieces in the receptacles and connect laser light fibers and radio frequency (HF) cable with the unit.
Pay attention to the color codes
• Connect the neutral electrode.
• Push the power switch (back).
• The unit runs an IMMEDIATE self-test in the background.
Label
At the back of the device:
(For legend see page 14)
At the front of the unit:
between the two laser outputs
User Manual
6450100009
1261
D001
Type:


      

Dual User Conception:
It is possible to choose every single application (mode) by using the touch screen as well as by using the receptacle (except
BIPOLAR). For safety reasons the simultaneous selection of a mode via touch screen or via receptacle is intended in the following way:
• Whenever a button of mode is displayed in color, the mode can be started or finished using the touch screen or the receptacle switches.
• Once a mode has been selected, it cannot be interrupted with another mode button and another receptacle.
• The BIPOLAR MODE can be selected only by touch screen.
• It is possible to „pre-select“ a mode by activating the according mode button, even without taking the handpiece from the receptacle.
• With the exception of BIPOLAR, the handpiece has always to be taken out of the receptacle for activation.
Back
1. 230 v power supply with fuses and
main switch
2. Interlock
3. Foot switch
4. Potential equalization
A connection with good electrical
conductivity that minimizes diffe-
rent electrical potentials. Colloqually
often referred to as earthing.
5. Type label
6. Laser type
7. Ventilation
Front
1. Receptacle switch radio frequency (HF)
2. Display (touch screen)
3. EMERGENCY-switch
(on top of unit)
4. Receptacle switch LASER
5. Neutral electrode
6. Output HF CUT
7. Output HF COAG
8. Output HF BIPOL
9. Output laser 660 nm
10. Output laser 975 nm
1
2
34
56
7
1
2
3
4
5678910
User Manual
14

Neutral electrode
HF-electrode CUT HF-electrode COAG
Standard handpiece
HF
LASER
Fiber
Laser handpiece 975 nm
Laser handpiece 660 nm
User Manual
15

16
Start
Start the unit by using the power switch at the back of the unit.
The unit’s HF-mode is ready for use without requiring a code. When
starting the Laser and PDT program, you are asked to enter a User
Code.
Laser: Master code 9-9-9-9
(both program, Laser and PDT become activated)
PDT: User Code 0-0-0-0
(User code for persons being entitled to use the PDT Laser)
The master code entitles the operator to use the 975 nm and 600 nm
Laser. Should the master code have been used to activate the device
and should a PDT-Laser use be indicated, switch off/on the device and
activate it by entering the user code.
For your own safety, make sure to change the code during first use, see
pages 17/19.
If the user code matches the correct four-digit code, the according me-
nue appears. If however, the code input fails, you will be
asked to enter the code again.
With acceptance of the user code the main menu will appear:
CUT
COAG
BIPOL
PDT
LASER
Information
As well as display of software version
Following possibilities are available:
• Go to information menu by pressing the button in the right upper corner
• Mode selection by buttons – pressing of one of the colored buttons directly lead to a mode. If a mode selection button
is GRAY, it is not possible because another mode is active.
• Mode selection by receptacle – by taking the handpiece from the receptacle switch the appropriate mode will be selected,
if no other mode is active.
Information
= Information
- Loudness warning sound
- Return to factory settings
- Adjustment of display
- Brightness of display
- User code setting
- Language
User Manual

17
Adjustment of loudness for warning sound (window)
On/Off for sound of button
Reset to factory setting
Adjustment of display (special display)
Adjustment of brightness display (window)
Brightness of pilot laser (window)
User code setting
Language: Deutsch, English (window)
Touch one of the symbol buttons – with exception of FACT SET,
SIGNAL ON/OFF, JUSTAGE DISPLAY, CODE SET – and a green
window appears. Settings can be changed by using the and but-
tons and accepted by using the button.
User Manual

18
Settings:
Sound for buttons
The sound for button confirmation can be set ON/OFF.
Brightness of display
Brightness of pilot laser
Loudness of warning sounds
Brightness of the display can be set in steps 1 – 10,
confirm with button.
Brightness of the pilot laser can be set in steps 1 – 10,
confirm with button
Loudness of the warning sounds (ATTENTION: radio frequency and
laser have different sounds) - can be set in steps 1 – 10,
confirm with button.
User Manual

19
Adjustment of display
The display can be adjusted horizontally and vertically. For this purpose
use a sharp instrument (i.e. pencil, ballpoint) and SLIGHTLY touch the
main lines, until you hear a long sound occurs. Short sounds signal the
ongoing adjustment.
Confirm by pressing the middle button, until sound occurs.
User code setting
The user of the LaserHF device can change the 4 digit codes and store
with the button.
Reset to factory settings by pressing and holding the button – until sound occurs. All storable parameters – except
CODE – will be resetted to factory settings.
If you have forgotten your USER CODE, please contact HAGER & WERKEN by email: [e-mail] and mention the
device number of your laser to receive a new user code.
User Manual

20
Precision of power setting radio frequency (HF)
The power of the radio frequency generator depends on
the tissue specific resistance and can vary within limits.
The specified 50 W are in accordance with a specific
resistance of 1 kΩ. The settings of the radiofrequency
will be displayed without the measuring unit [W] and
will be scaled in accordance with the graph.
User Manual
0
10
20
30
40
50
60
0500 1000 1500 2000
P/W
R/W
HF-Leistung in Betriebsart "Cut" vs. Last
25
50
0
10
20
30
40
0 500 1000 1500 2000
P/W
R/W
HF-Leistung vs. Last in Betriebsart "Cut/Coag" bzw. "Coag"
bei verschiedenen Leistungseinstellungen, Koagulationsgrad C4
15
30
0
10
20
30
40
0 100 200 300 400 500 600 700 800 900 1000
P/W
R/W
HF-Leistung vs. Last in Betriebsart "Bipolar Coag"
bei verschiedenen Leistungseinstellungen, Koagulationsgrad C4
15
30
Meyer-Haake Innovations GmbH / Ahlmeier GmbH 18.07.2017
0
50
100
150
200
250
300
350
0 10 20 30 40 50
U/V
Leistungsanzeige
Max. Ausgangsspannung in Betriebsart "Cut"
0
50
100
150
200
250
300
350
0 10 20 30
U/V
Leistungsanzeige
Max. Ausgangsspannung vs. Anzeige in Betriebsart
"Cut/Coag" bzw. "Coag", Koagulationsgrad C4
0
25
50
75
100
125
150
175
0 10 20 30
U/V
Leistungsanzeige
Max. Ausgangsspannung in Betriebsart
"Bipolar Coag", Koagulationsgrad C4
HF-power in operating mode „Cut“ vs. load
HF-power vs. Ioad in operating mode „Cut/Coag“ or „Coag“ in
various power settings, coagulation level C4
HF-power vs. Ioad in operating mode „Bipolar Coag“ in
various power-settings, coagulation level C4
Max.output voltage vs. visual display in operating mode
„Cut/Coag“ or „Coag“, coagulation level C4
Max. output voltage in operating mode
„Bipolar Coag“, coagulation level C4
Max. output voltage in operating mode „Cut“
Performance indicator
Performance indicator
Performance indicator