KaVo KEY Laser 3+ 1343 User manual

Instructions for use
KEY Laser 3+ 1343
KEY Laser III 1243 upgraded
Always be on the safe side.

Distributed by:
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
Tel. [phone]
Fax [phone]
Manufacturer:
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com

Table of contents
1 User instructions ........................................................................................................................................ 4
1.1 Service .............................................................................................................................................. 4
1.2 Purpose – Proper use ........................................................................................................................ 4
1.2.1 Training opportunity .............................................................................................................. 4
1.2.2 Effects .................................................................................................................................. 5
1.2.3 Indications and contraindications ......................................................................................... 5
1.3 Important instructions ........................................................................................................................ 7
1.3.1 Registration .......................................................................................................................... 7
1.4 Packages .......................................................................................................................................... 7
1.4.1 Weight and IDs ..................................................................................................................... 7
1.4.2 Packaging ordinance of August 28,1998 .............................................................................. 8
2 Safety ........................................................................................................................................................ 9
2.1 Safety instructions ............................................................................................................................. 9
2.1.1 Description of danger levels ................................................................................................. 9
2.1.2 Hazard levels ........................................................................................................................ 9
2.1.3 Warning symbol .................................................................................................................... 9
2.1.4 Structure ............................................................................................................................... 9
2.2 Laser safety ..................................................................................................................................... 10
2.2.1 Safety instructions .............................................................................................................. 10
2.3 Safe use .......................................................................................................................................... 11
2.3.1 General Safety Instructions ................................................................................................ 11
2.3.2 Disposal of electronic and electrical devices ...................................................................... 13
2.3.3 Personal eye protection ...................................................................................................... 14
2.3.4 Safety of the construction ................................................................................................... 14
2.3.5 Electromagnetic compatibility ............................................................................................. 14
2.4 Safe laser range .............................................................................................................................. 15
2.4.1 Warning lamps ................................................................................................................... 16
2.4.2 Warning signs ..................................................................................................................... 16
2.5 Electromagnetic compatibility .......................................................................................................... 16
2.5.1 Electromagnetic Transmissions ......................................................................................... 17
2.5.2 Resistance to electromagnetic interference ....................................................................... 17
2.5.3 Recommended safe distances ........................................................................................... 19
3 Device description ................................................................................................................................... 20
3.1 KEY Laser 3+ 1343 (Mat. no. 1.006.4200) ...................................................................................... 20
3.1.1 Multifunctional foot control .................................................................................................. 21
3.1.2 Rear of the laser device ..................................................................................................... 22
3.2 Touchscreen .................................................................................................................................... 23
3.3 Type plate and power rating plate ................................................................................................... 24
3.4 Location to affix the laser warning plates and laser reference ........................................................ 26
3.5 Technical data and requirements .................................................................................................... 27
4 Operation ................................................................................................................................................. 30
4.1 Emergency-off switch ...................................................................................................................... 30
4.2 Fill the spray water .......................................................................................................................... 30
4.3 Laser hose and handpieces ............................................................................................................ 31
4.3.1 Laser hose .......................................................................................................................... 31
4.3.2 Couple the handpieces ....................................................................................................... 32
4.3.3 Undo the connection .......................................................................................................... 33
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
Table of contents
1/76

4.4 Switching on .................................................................................................................................... 34
4.4.1 Energy-saving mode .......................................................................................................... 36
4.5 Using the touchscreen ..................................................................................................................... 36
4.6 Ready state ..................................................................................................................................... 37
4.6.1 Trigger laser pulses ............................................................................................................ 38
4.6.2 Interrupting ready mode ..................................................................................................... 38
4.6.3 Ending ready mode ............................................................................................................ 39
4.7 Setting pulse energy and pulse frequency ...................................................................................... 39
4.7.1 Selecting the pulse energy ................................................................................................. 39
4.7.2 Select pulse frequency ....................................................................................................... 40
4.7.3 Display of average performance ....................................................................................... 40
4.8 User test with handpiece 2060 ........................................................................................................ 40
4.9 Modes .............................................................................................................................................. 41
4.9.1 Switch mode ....................................................................................................................... 42
4.9.2 Standard therapy mode ...................................................................................................... 42
4.9.3 S-PULSE (short pulses) ..................................................................................................... 43
4.9.4 Detection mode .................................................................................................................. 43
4.9.5 Feedback mode .................................................................................................................. 43
4.10 Setting the threshold ....................................................................................................................... 44
4.11 Spray settings .................................................................................................................................. 45
4.11.1 Media default ...................................................................................................................... 45
4.11.2 Footswitch .......................................................................................................................... 46
4.11.3 Spray test ........................................................................................................................... 47
4.12 System menu .................................................................................................................................. 47
4.13 Programs ......................................................................................................................................... 48
4.13.1 Program selection .............................................................................................................. 48
4.13.2 Program selection menu .................................................................................................... 48
4.13.3 Delete program ................................................................................................................... 49
4.14 Program settings ............................................................................................................................. 49
4.14.1 New program ...................................................................................................................... 50
4.14.2 Reset the new settings ....................................................................................................... 51
4.14.3 Pilot beam setting ............................................................................................................... 51
4.15 Handpiece selection ........................................................................................................................ 51
4.16 Detector adjustment ........................................................................................................................ 52
4.16.1 Check or change the reference value ................................................................................ 53
4.16.2 Start adjustment ................................................................................................................. 53
4.16.3 Determining the zero value ................................................................................................ 54
4.16.4 Determine reference value ................................................................................................. 54
4.16.5 Complete detector adjustment ........................................................................................... 55
4.17 Spray regulation .............................................................................................................................. 55
4.18 Switching off .................................................................................................................................... 56
4.19 System menu .................................................................................................................................. 57
5 Setup methods according to DIN EN ISO 17664 .................................................................................... 59
5.1 Manual cleaning .............................................................................................................................. 60
5.2 Machine cleaning ............................................................................................................................ 60
5.3 Manual disinfection .......................................................................................................................... 60
5.4 Automated disinfection .................................................................................................................... 61
5.5 Sterilisation ...................................................................................................................................... 61
5.6 Cooling circuit .................................................................................................................................. 61
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
Table of contents
2/76

6 Safety checks .......................................................................................................................................... 62
6.1 Scope of tests .................................................................................................................................. 62
6.2 Safety check of energy .................................................................................................................... 62
6.3 Handpieces ..................................................................................................................................... 63
6.4 Protective conductor test according to DIN VDE 0751 Part 1 ......................................................... 63
6.5 Replacement device leakage current test according to DIN VDE 0751 Part 1 ............................... 63
6.6 Additional tests ................................................................................................................................ 64
6.7 Safety check report (example) ........................................................................................................ 65
7 Accessories ............................................................................................................................................. 66
7.1 Handpieces ..................................................................................................................................... 66
7.2 Warning signs .................................................................................................................................. 67
7.3 Laser safety goggles ....................................................................................................................... 68
7.4 references ....................................................................................................................................... 69
8 Malfunctions ............................................................................................................................................ 70
8.1 Error messages ............................................................................................................................... 70
8.2 Warning ........................................................................................................................................... 70
8.3 Malfunctions .................................................................................................................................... 70
8.4 Troubleshooting ............................................................................................................................... 71
9 Assembly instructions .............................................................................................................................. 73
9.1 Floor composition ............................................................................................................................ 73
9.2 Media ............................................................................................................................................... 73
9.2.1 Spray water ........................................................................................................................ 73
9.2.2 Spray air ............................................................................................................................. 73
9.3 Electrical connection ....................................................................................................................... 73
9.3.1 Customer ............................................................................................................................ 73
9.3.2 On the unit 230 V version ................................................................................................... 74
9.3.3 On the unit 100-127 V version ............................................................................................ 74
9.4 Transportation and storage ............................................................................................................. 74
9.4.1 In the dental practice .......................................................................................................... 74
9.4.2 Outside of the dental practice ............................................................................................. 74
9.5 What should be done if there is damage from transportation? ........................................................ 75
9.6 Setup plan ....................................................................................................................................... 75
9.7 Installing the door switch ................................................................................................................. 75
10 Setup plan ............................................................................................................................................ 0
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
Table of contents
3/76

1 User instructions
1.1 Service
Service hotline:
[phone]
[email protected]
Please indicate the product serial number in all requests.
Additional information can be obtained at: www.kavo.com
To ensure that the KEY 3+ / III upgraded maintains its value and is always ready for
use, have it serviced once a year as recommended.
Observe the respective national regulations.
The servicing covers all testing and safety checks.
1.2 Purpose – Proper use
Note
The KEY Laser 3+ / III upgraded is a dental treatment device in accordance with
ISO 74 94.
The device can be used in hospitals and private practices and can be transported.
Note
The device is not suitable for use in surgical theatres.
Note
The KEY Laser 3+ / III upgraded may not be used in areas in which flammable
anaesthetics or flammable agents are used for disinfection or skin cleaning.
The KEY Laser 3+ / III upgraded is for use by physicians. The treating physician is
exclusively responsible for determining the suitability of the device and selecting the
corresponding treatment methods.
The KaVo KEY Laser 3+ / III upgraded is a universally usable erbium laser for den‐
tistry in the dental environment for oral, jaw and facial surgery. With its variable pulse
lengths, it is appropriate for treating enamel, bone and concrements and for pro‐
cessing soft tissue, (mucosa, muscle and connective tissue).
Note
A current application manual can be obtained at any time from KaVo.
1.2.1 Training opportunity
Training options are available at www.kavo.com "Fortbildung" [Continuing educa‐
tion].
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
1 User instructions | 1.1 Service
4/76

1.2.2 Effects
The physiological and biological effects of laser radiation on tissue, safety consid‐
erations (effects on the eye) and treatment instructions are described in a separate
application manual.
1.2.3 Indications and contraindications
Therapy Indications Contraindications
General Patients who suffer from photoder‐
matosis and photosensitive patients
(photoallergies).
Surgery on patients with serious
diseases of the hemopoietic system
(such as haemophilia and leukae‐
mia).
Ablation of primary carious lesions
in the region far from the pulp
Primary carious lesions in the re‐
gion far from the pulp.
Crown stump preparations
Cavities for preparing cast fillings
without subsequent mechanical
treatment
Ablation of primary carious lesions
in dentin close to the pulp
Primary carious lesions in the re‐
gion close to the pulp.
Crown stump preparations
Cavities for preparing cast fillings
without subsequent mechanical
treatment,
Ablation of secondary carious le‐
sions
Secondary carious lesions that are
filled with composite (small cavities
or residual composite), or cement.
Amalgam fillings must be mechani‐
cally removed before laser therapy.
Given the good reflection of IR radi‐
ation by gold, gold fillings must be
mechanically removed beforehand.
Crowns must be mechanically re‐
moved before laser therapy.
Metal should not be irradiated since
it can heat the surrounding tissue.
Likewise, spatter from removed
metal can damage peripheral tissue
and quickly damage the window.
Dentin conditioning Condition the dentin surface to pro‐
mote the adhesion of the filling in
cavities that were upgraded using
the KEY Laser 3+ / III or were pre‐
pared by a rotating instrument.
None known.
conditioning the enamel Condition the enamel surface to
promote the adhesion of composite
fillings in cavities that were upgra‐
ded using the KEY Laser 3+ / III or
were prepared by a rotating instru‐
ment.
None known.
Fissure sealing Preventative seal of caries-free mo‐
lars and premolars
Enhanced fissure sealing after initial
preparation of the curious fissure.
None known.
root canal disinfection: Reduction of germs in the root canal
after mechanical preparation for vi‐
tal extirpation or treatment of an in‐
fected canal.
None known.
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
1 User instructions | 1.2 Purpose – Proper use
5/76

Therapy Indications Contraindications
Incision, excision Incision for draining abscesses.
Frenectomy, incision of cheek liga‐
ments
Excision of fibromas, flap fibromas,
Gingivectomy for gingiva hyperpla‐
sias or excision of hyperplasias.
Preprosthetic surgery: Alveolar flab‐
by ridge, vestibuloplasty, implant
exposure, hyperplasia, epulides,
papillomas, fibromatosis, benign
growths.
Malignant tumours, obligate pre‐
cancerous tumours, hemangiomas
(According to the present state of
knowledge)
Ablation of diseases of the oral mu‐
cosa covering flat areas
Simple mucosal diseases such as
Leukoplakia simplex, idiopathic leu‐
koplakia, Lichen ruber planus, hy‐
perkeratosis and aphthae.
Malignant tumours, obligate pre‐
cancerous tumours, hemangiomas
(according to the present state of
knowledge)
Implant exposure Exposure of the implant post after
transgingival or subgingival healing
in the alveolus by excision or inci‐
sion of the mucosal hood in two-
phase implants. The implant coping
(of plastic, metal or ceramic) should
completely cover the implant post.
None known.
Fibroma excision Pediculate fibromas, broad-based
fibromas or flap fibromas on soft/
hard gums, cheek mucosa, lips,
tongue margin or tongue base and
gingiva, hyperplasias, including
epulis, Granuloma teleangiectati‐
cum
None known.
Frenectomy Correction of high-inserted lip,
tongue and cheek ligaments that
extend too far into the alveolar ridge
or the marginal gingiva and thereby
impair function, phonetics, the seat
of the prosthesis, et cetera.
None known.
Root tip resection Root tip resection of teeth with per‐
iapical lesions on which prior endo‐
dontic treatment was unsuccessful,
or in which a revision is not recom‐
mendable (such as large cysts or a
large prosthetic restoration).
Use of the KEY Lasers 3+ / III up‐
graded for opening the bone win‐
dow and for root tip resection.
As usual (particularly in regard to
systemic diseases). Close to an in‐
ferior nerve canal.
Poor accessibility.
Root canals that are provided with
metal pins extending to the apex.
Curettage Removal of subgingival concre‐
ments in periodontal pockets with
periodontitis with closed or open
curettage.
None known.
Curettage with detection Removal of subgingival concre‐
ments on subgingival root surfaces
with periodontitis with closed door
open curettage including the detec‐
tion function of the KEY Lasers 3+ /
III upgraded.
None known.
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
1 User instructions | 1.2 Purpose – Proper use
6/76

1.3 Important instructions
Note
The instructions fur use must be read by the user before start-up to prevent im‐
proper use and damage.
It is possible that the product may be modified or improved on the basis of new
technical developments. An entitlement to update the product does not follow.
KaVo cannot accept responsibility for damage caused by:
▪ External factors beyond its control (poor media quality or defective installation)
▪ The use of incorrect information,
▪ Improper use,
▪ Improper installation, startup and repairs.
The KEY Laser 3+ / III upgraded may only be installed, repaired and serviced by
technicians who have successfully passed KEY Laser 3+ / III upgraded training.
Permits become void upon non-observance.
Note
only original KaVo replacement parts may be used.
Note
The device may not be altered without the manufacturer's permission.
Note
Additional steps for installation or startup as well as service of the KEY Laser 3+ /
III upgraded must be performed by a technician trained by KaVo. These steps are
described in training documents. The technician obtains these after successfully
completing training for the KEY Laser 3+ / III upgraded.
1.3.1 Registration
The operator in the Federal Republic of Germany is required to register the KEY
Laser 3+ / III upgraded before first to start up at:
▪ the responsible trade board
▪ the responsible Employee Liability Insurance
The respective national regulations regarding operation must be observed in other
countries.
1.4 Packages
1.4.1 Weight and IDs
See also: 3.5 Technical data and requirements, Page 27
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
1 User instructions | 1.3 Important instructions
7/76

1.4.2 Packaging ordinance of August 28,1998
Note
Only valid for the Federal Republic of Germany
Properly dispose of and recycle the sales packaging according the applicable pack‐
aging ordinance through waste management businesses or recycling companies
within a comprehensive return system. KaVo has licensed its sales packaging in
accordance with this directive. Please follow the regional public waste disposal
system.
Styrofoam
EPSY GmbH
Kaiser Friedrich Promenade 89
81348 Bad Homburg v. d. H.
08062-3691
08062-8574
Ethafoam
SCHERTLER VERPACKUNGEN
Eulatalstraße 31-39
Postfach 1720
86622 Neuburg/Donau
08431-5060
08431-50660
How do I identify Ethafoam (PE foam = non-crosslinked polyethylene foam)?
▪ It is elastic but cannot be completely compressed
▪ It is not permeable to air
▪ It does not break up (an important difference from Styrofoam)
▪ It is not absorbent
Cardboard
RESY GmbH
Hilpertstr. 22
Postfach 4212
64295 Darmstadt
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
1 User instructions | 1.4 Packages
8/76

2 Safety
2.1 Safety instructions
2.1.1 Description of danger levels
Safety instructions with three hazard levels are used in this document for avoiding
personal and property damage.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property, or mild or
moderate physical harm.
WARNING
WARNING
indicates a hazardous situation that can cause death or serious injury.
DANGER
DANGER
indicates the maximum hazard level. indicates a directly hazardous situation that
can cause death or serious injury.
2.1.2 Hazard levels
DANGER indicates the maximum hazard level. indicates a directly hazardous sit‐
uation that can cause death or serious injury.
WARNING indicates a hazardous situation that can cause death or serious injury.
CAUTION indicates a hazardous situation that can cause damage to property, or
mild or moderate physical harm.
2.1.3 Warning symbol
Warning symbol
2.1.4 Structure
DANGER
The introduction describes the type and source of the danger.
This section describes the potential consequences of non-observance.
▶The optional step covers measures necessary for avoiding hazards.
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
2 Safety | 2.1 Safety instructions
9/76

2.2 Laser safety
2.2.1 Safety instructions
Medical Device Law (only applicable for Germany)
The KEY 3+ / III upgraded is a class II b device according to EC directive 93/42/
EEC.
In Germany, operators, equipment managers and users are obliged to operate their
equipment in accordance with the Medical Device Act regulations.
In particular, such devices may only be operated in accordance with the generally
recognized rules of technology and occupational health protection and accident
protection regulations.
Note
Country-specific provisions must be observed when operating a medical laser. In
the Federal Republic of Germany, the respectively valid version of the regulations
of German professional associations on safety (BGV) for laser radiation BGV B2
must also be observed.
Accessories by other manufacturers may not be used.
Note
The operator must install a warning light and warning sign before each entrance
door to the treatment room in which the KEY Laser 3+ / III upgraded is located.
(identification of the laser treatment room according to BGV B2)
In addition, operators in Germany are required to keep a medical device book. Our
service technician can be of assistance in filling it out.
Note
The medical device book is included in the delivery.
Legal provisions
Apply and meet the overarching guidelines and/or national laws, national regula‐
tions and the rules of technology for medical devices applicable for startup and use
of the KaVo product for the intended purpose.
Observe IEC 60825-1 in its entirety.
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
2 Safety | 2.2 Laser safety
10/76

Safety checks
Note
Make sure that the devices undergo regular annual safety checks and document
the results.
Information on the schedule and scope of the safety checks are in the assembly
instructions.
Requirements for correct operation
Responsibility is assumed for the safety, reliability and performance of the unit when:
▪ Installation, expansions, adjustments, changes or repairs must be done by tech‐
nicians trained by KaVo.
▪ Individuals have been assigned the responsibility of protecting the laser.
▪ The electrical system in the relevant room meets the requirements and regula‐
tions of VDE 0107 and VDE 0100.
▪ The unit is operated according to the instructions for use. All the provisions of
VDE 0751 are followed in maintenance.
This unit has been tested in accordance with:
▪ IEC 60601-1/VDE 0750 part 1
▪ ISO 7494
▪ IEC 60825-1 / VDE 0837 part 1
▪ VDE 0750 part 2-22
2.3 Safe use
2.3.1 General Safety Instructions
CAUTION
Malfunctions due to electromagnetic fields.
The product meets the applicable requirements regarding electromagnetic fields.
Given the complex interactions between equipment and cell phones, the product
may be influenced by a cell phone that is in use.
▶Do not use cell phones in medical offices, hospitals, or laboratories.
▶Put electronic devices such as e.g. computer storage media, hearing aids etc.
down during operation!
The KaVo product is not permitted to be used in areas subject an explosion hazard.
The user must ensure that that the unit works properly and is in a satisfactory con‐
dition before each use.
CAUTION
Danger from damaged operating parts
When operating parts are damaged, they may not be used.
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
2 Safety | 2.3 Safe use
11/76

CAUTION
Hazard of air embolism and skin emphysema.
There is a danger that the insufflation of spray in open wounds in the surgical area
can cause air embolisms and skin emphysema.
▶Avoid the insufflation of spray in open wounds in surgical area!
CAUTION
Damage from long periods of disuse
Due to stagnation, damage can arise during first use or after periods of disuse
(weekends, holidays, vacation, etc.).
▶Rinse or blow out spray-conducting lines in treatment devices.
▶Remove the handpiece from the holder, and operate intermittently with spray.
CAUTION
Hazards from the unsupervised use of lasers
Before leaving the treatment room, turn off the KEY Laser 3+ / III upgraded and
protect against unauthorized use:
▶Turn off the main power switch.
▶Remove the key from the key-operated switch.
CAUTION
Hazard from previous illness and susceptibility to haemorrhaging
Haemorrhaging or other reactions dangerous to patients.
▶Ask patients about prior illnesses, haemophilia, etc. before treatment.
CAUTION
Damage from tipping
The laser device contains a water cooler for cooling.
▶Never tip the KEY Laser 3+ / III upgraded or lay it on its side!
CAUTION
Damage from transport
Property damage
▶Only pull the KEY Laser 3+ / III upgraded on the grip along the device when
transporting it.
▶When transporting it over a threshold, only pull in the direction of the arm and
slightly lift the device.
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
2 Safety | 2.3 Safe use
12/76

Pacemakers
CAUTION
Risks from electromagnetic fields.
The functions of implanted systems (such as pacemakers) can be influenced by
electromagnetic fields.
▶Observe current updates in journals.
▶Ask patients before treatment.
▶Have the patient present identification that he or she wears a pacemaker to
assess potential hazards.
▶Evaluate the risks and benefits.
▶Take suitable emergency precautions and immediately react to any changes
in health.
▶Monitor symptoms such as elevated heart rate, irregular pulse and dizziness.
These can indicate problems with a pacemaker.
2.3.2 Disposal of electronic and electrical devices
Note
According to EC directive 2002/96 concerning used electrical and electronic devi‐
ces, this product is subject to the cited directive and must be disposed of accord‐
ingly within Europe.
Before disassembling / disposing of the product, it must be completely processed
(disinfected, sterilized) according to the section "Preparation methods"
Additional information can be obtained from KaVo (www.kavo.com) or your dental
supplier.
For final disposal, contact:
Germany
To return an electrical device, proceed as follows:
1. At the homepage www.enretec.de of enretec GmbH, you can download a form
for a disposal request under the menu item eom, or you can use it as an online
request.
2. Fill out the request with the corresponding information, and send it as an online
request or by fax [phone]) to enretec GmbH.
The following avenues are also available for questions and for initiating a dis‐
posal request:
Telephone: [phone]
E-mail: [email protected] and
Post: enretec GmbH, eomRECYCLING Department
Kanalstraße 17
16727 Velten
3. Yourmovabledevice will be picked up in your practice, and yourpermanently in‐
stalledunit will be picked up at the curb at your address on the agreed deadline.
The owner or user of the device will bear the costs for disassembly, transporta‐
tion and packaging.
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
2 Safety | 2.3 Safe use
13/76

International (EU)
For country-specific information on disposal, contact your dental supplier.
2.3.3 Personal eye protection
All of the persons that are in the range of the laser during treatment must wear laser
safety goggles. The laser safety goggles must be in conformance with safety level
L3 (DIN EN 207), wavelength 2.94 µm.
See also: 7 Accessories, Page 66
CAUTION
Laser beam hazard
Irreversible eye damage.
▶Observe the instructions accompanying the laser safety goggles.
▶Do not activate the laser when the handpiece is not mounted.
▶Never look into the distal end of the handpiece, laser hose coupling or the laser
hose, either with or without the laser safety goggles!
2.3.4 Safety of the construction
The KEY Laser 3+ / III upgraded was constructed according to the relevant safety
standards such as IEC 60601-1 , IEC 60825-1 and VDE 0837 .
Numerous measures have been undertaken to ensure both active safety with sub‐
stantial comfort during use.
The user will not be directly aware of many of these measures:
▪ Directly after turning the device on, the microprocessor control will run a self-
check.
▪ Then a series of safety-relevant components will be operated and tested. If the
test is unsuccessful, the device will turn off again.
▪ If the test is successful, the device will go to standby mode.
▪ During operation, the proper functioning of the microprocessor control and all
safety-relevant components is continuously checked.
▪ Maximum value was placed on preventing the malfunctioning of individual com‐
ponents from endangering the physician, dental personnel, patients, or third
parties.
2.3.5 Electromagnetic compatibility
Note
Based on EN 60601-1-2 concerning the electromagnetic compatibility of electro‐
medical devices, the following should be noted:
• Medical electrical devices are subject to special measures regarding electromag‐
netic compatibility and must be operated in accordance with KaVo assembly in‐
structions.
• Portable and mobile high-frequency communications devices can influence elec‐
trical medical devices.
- Further details on the technical EMC description can be made available on re‐
quest.
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
2 Safety | 2.3 Safe use
14/76

CAUTION
Damage from incorrect accessories
The use of other accessories, transformers and lines than those indicated (with the
exception of transformers and lines that KaVo sells as replacement parts for in‐
ternal components) can increase transmission or reduce the electromagnetic im‐
munity of the product.
▶Only use accessories recommended by KaVo.
Note
KaVo cannot guarantee that accessories, lines and transformers not delivered by
KaVo will correspond with EMC requirements of EN 60601-1-2.
2.4 Safe laser range
Note
Each time the KEY 3+ / III upgraded is started, the regulations for operating lasers
must be observed.
The room must be identified by the required warning signs and lights at all points
of entry.
m
a
e
B
-
r
e
s
a
L
m
a
e
B
-
r
e
s
a
L
① Warning lamps ② Warning signs
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
2 Safety | 2.4 Safe laser range
15/76

2.4.1 Warning lamps
In the planning stage, make sure that warning lights are installed at all entrance
doors to the treatment rooms in which the KEY Laser 3+ / III upgraded is operated.
If possible, install the electronics as follows:
The warning lights operate when power is applied to the socket for the KEY Laser
3+ / III upgraded.
The warning lights must be installed by a professional electrician.
Note
The warning lamps are not included with the delivery of the KEY Lasers 3+ / III
upgraded.
2.4.2 Warning signs
The current warning signs are to be affixed at eye height to the entrance doors to
the treatment room in which the KEY laser 3+ / III upgraded is used and be visible
from the outside.
Note
The warning signs are included in the accessories.
See also: 7 Accessories, Page 66
2.5 Electromagnetic compatibility
The KEY Laser 3+ / III upgraded is for use in an environment like the one cited
below. The customer or user of the KEY Laser 3+ / III upgraded must ensure that it
is operated in such an environment.
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
2 Safety | 2.5 Electromagnetic compatibility
16/76

2.5.1 Electromagnetic Transmissions
Measurements of noise transmis‐
sions
Conformance Electromagnetic environment -
guidelines
HF transmission according to
CISPR 11
Group 1 The KEY Laser 3+ / III upgraded
uses HF energy only for its internal
operation. Its HF transmission is
therefore very low, and it is improb‐
able that neighbouring electronic
devices will be disturbed.
HF transmission according to
CISPR 11
Class B The KEY Laser 3+ / III upgraded is
for use in all facilities including resi‐
dential ones, and facilities that are
directly connected to a public power
supply that also supplies residential
buildings.
Transmission of harmonics accord‐
ing to IEC 61000-3-2
Class A ditto
Transmission of voltage fluctuations
or flicker according to IEC
61000-3-3
In conformance ditto
2.5.2 Resistance to electromagnetic interference
The KEY Laser 3+ / III upgraded is for use in an environment like the one cited
below. The customer or user of the KEY Laser 3+ / III upgraded must ensure that it
is operated in such an environment.
Immunity tests IEC 60601 test level Conformance level Electromagnetic environ‐
ment - guidelines
Electrostatic discharge
(ESD) according to IEC
61000-4-2
± 6 kV contact discharge ±
8 kV air discharge
± 3 kV contact discharge ±
8 kV air discharge
Floors should be made of
wood or concrete or have
ceramic tiles. When the
floor is made of synthetic
material, the relative hu‐
midity must be at least
30%.
Fast transient electrical
disturbances/ Bursts ac‐
cording to IEC 61000-4-4
± 2 kV for power lines ± 1
kV for input and output
lines
± 2 kV for power lines The quality of the supply
voltage should correspond
to that of a typical business
or hospital environment.
Surges according to IEC
61000-4-5
± 1 kV normal mode volt‐
age ± 2 kV common-mode
voltage
± 1 kV normal mode volt‐
age ± 2 kV common-mode
voltage
The quality of the supply
voltage should correspond
to that of a typical business
or hospital environment.
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
2 Safety | 2.5 Electromagnetic compatibility
17/76

Immunity tests IEC 60601 test level Conformance level Electromagnetic environ‐
ment - guidelines
Voltage interruptions,
short-term interruptions
and fluctuations of the
supply voltage according
to IEC 61000-4-11
< 5% UT
(>95% interruption)
for 1/2 period
40 % UT
(60 % interruption)
for 5 periods
70 % UT
(30% interruption)
for 25 periods
< 5% UT
(>95% interruption)
for 5 s
(250 periods)
< 5% UT
(>95% interruption)
for 1/2 period
40 % UT
(60 % interruption)
for 5 periods
70 % UT
(30% interruption)
for 25 periods
< 5% UT
(>95% interruption)
for 5 s
(250 periods)
The quality of the supply
voltage should correspond
to that of a typical business
or hospital environment.
When the user of the KEY
Lasers 3+ / III upgraded
needs continued operation
even when the power sup‐
ply is interrupted, it is rec‐
ommended to supply the
KEY Lasers 3+ / III upgra‐
ded from an uninterrupted
power supply or a battery.
Magnetic field with a sup‐
ply frequency (50/60 Hz)
according to IEC
61000-4-8
3 A/m 3 A/m Magnetic fields at the
mains frequency should
correspond to typical val‐
ues in a business and hos‐
pital environment.
Note: V T is the alternating mains voltage before the test level is used.
Immunity tests IEC 60601 test level Conformance level Electromagnetic environment -
guidelines
Conducted HF distur‐
bances according to
IEC 61000-4-6
3 V eff 150 kHz to 80
MHz outside of ISM
bandsa
10 Veff Portable and mobile radio devices
should not be used closer to the
KEY Lasers 3+ / III upgraded in‐
cluding the wires, than the recom‐
menced safe distance calculated
using the equation for the transmis‐
sion frequency.
Recommended safe distance:
d=0.35 P
d=0.35 P for 80 MHz to 800 MHz
d=0.70 P for 800 MHz to 2.5 GHz
with P as the maximum rated power
of the transmitter in Watts (W) ac‐
cording to the transmitter manufac‐
turer, and d as the recommended
safe distance in meters (m).
bThe field strength of stationary ra‐
dio transmitters should be less than
the conformance level at all fre‐
quencies in an on-site checkc.
d Close to devices that have the fol‐
lowing symbol disturbances are
possible.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not be applicable in every case. The spread of elec‐
tromagnetic waves is absorbed and reflected by buildings, objects and people.
a The ISM frequency bands (for industrial, scientific and medical applications) be‐
tween 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567
MHz; 26.957 MHZ to 27.283 MHz and 40.66 MHz to 40.70 MHz.
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
2 Safety | 2.5 Electromagnetic compatibility
18/76