Instructions for use GENTLEray 980 | US

Transcription

Instructions for use
GENTLEray 980 | US
Always be on the safe side.
Distributed by:
KaVo Dental Corporation
11729 Fruehauf Drive
Charlotte, NC 28273 USA
Tel.: 847 550 6800
Fax: 847 550 6825
Manufacturer:
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com
Table of contents
Table of contents
1
2
3
4
5
User instructions ........................................................................................................................................ 3
1.1 User guide ....................................................................................................................................... 3
1.1.1 Abbreviations ...................................................................................................................... 3
1.1.2 Symbols .............................................................................................................................. 3
1.1.3 Target group ....................................................................................................................... 3
1.2 Service ............................................................................................................................................ 3
1.3 Warranty provisions ......................................................................................................................... 4
1.4 Transportation and storage ............................................................................................................. 4
1.4.1 Currently valid packaging regulations ................................................................................ 4
1.4.2 Damage in transit ............................................................................................................... 4
1.4.3 Information on the packaging: Storage and transportation ................................................ 5
Safety ........................................................................................................................................................ 7
2.1 Description of safety instructions ..................................................................................................... 7
2.1.1 Warning symbol .................................................................................................................. 7
2.1.2 Structure ............................................................................................................................. 7
2.1.3 Description of hazard levels ............................................................................................... 7
2.2 Proper use ....................................................................................................................................... 7
2.2.1 General information ............................................................................................................ 7
2.2.2 Product-specific .................................................................................................................. 9
2.3 Safety instructions ......................................................................................................................... 12
2.3.1 General information .......................................................................................................... 12
2.3.2 Product-specific ................................................................................................................ 12
Product description .................................................................................................................................. 16
3.1 GENTLEray 980 ............................................................................................................................ 16
3.2 Technical Data .............................................................................................................................. 17
3.3 Scope of delivery ........................................................................................................................... 19
3.4 Signage ......................................................................................................................................... 19
3.4.1 Rating plate ...................................................................................................................... 19
3.4.2 Warning and informational signs ...................................................................................... 20
3.5 Function description ...................................................................................................................... 22
First use ................................................................................................................................................... 24
4.1 Installation instructions .................................................................................................................. 24
4.2 Unpack the device ......................................................................................................................... 24
4.3 Connect the door contact .............................................................................................................. 25
4.4 Connect the footswitch. ................................................................................................................. 25
4.5 Connect the bare fibre .................................................................................................................. 26
4.6 Connect the unit to the electrical power supply ............................................................................. 27
Operation ................................................................................................................................................. 29
5.1 Safety equipment ......................................................................................................................... 29
5.1.1 Turn off the device with the power switch ........................................................................ 29
5.1.2 Turn on the device with the key-operated switch ............................................................. 29
5.1.3 Turn the laser off with the emergency-off switch .............................................................. 29
5.1.4 Turn the laser beam on and off with the footswitch .......................................................... 29
5.1.5 Standby mode ................................................................................................................. 30
5.1.6 Automatic shutoff .............................................................................................................. 30
5.2 Switching the machine on ............................................................................................................. 30
5.3 Main menu ..................................................................................................................................... 31
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Table of contents
5.4
"Settings" menu ............................................................................................................................ 32
5.4.1 Open the "Settings" menu ................................................................................................ 32
5.4.2 Change settings ............................................................................................................... 33
5.5 "Indication list" menu ..................................................................................................................... 34
5.5.1 Select indication ............................................................................................................... 34
5.5.2 Display information on the indication ................................................................................ 35
5.5.3 Change and save parameters of an indication ................................................................. 35
5.6 "Treatment" menu .......................................................................................................................... 36
5.6.1 Open the "Treatment" menu ............................................................................................. 36
5.6.2 Changing parameters ....................................................................................................... 36
5.7 Treatment ...................................................................................................................................... 38
5.7.1 Check door contact .......................................................................................................... 38
5.7.2 Make the laser ready ........................................................................................................ 38
5.7.3 Release the treatment beam ............................................................................................ 40
5.8 Switching the machine off ............................................................................................................. 41
6 Care ......................................................................................................................................................... 43
6.1 Machine cleaning and care .......................................................................................................... 43
6.1.1 Manual cleaning ............................................................................................................... 43
6.1.2 Machine cleaning ............................................................................................................. 43
6.2 Machine disinfection ...................................................................................................................... 44
6.2.1 Manual disinfection ........................................................................................................... 44
6.2.2 Machine disinfection ......................................................................................................... 44
6.3 Sterilisation in a steam steriliser .................................................................................................... 44
6.3.1 Sterilisation ....................................................................................................................... 44
7 Maintenance and safety checks .............................................................................................................. 46
7.1 Regularly perform safety checks ................................................................................................... 46
7.2 Scope of the annual safety checks ................................................................................................ 46
7.2.1 Bases ............................................................................................................................... 47
7.2.2 Implementation ................................................................................................................. 47
7.3 Preparations for changing location and transport .......................................................................... 48
8 Troubleshooting ....................................................................................................................................... 49
8.1 Malfunctions with error messages ................................................................................................. 49
8.2 Malfunctions without error messages ............................................................................................ 50
9 Information on electromagnetic compatibility .......................................................................................... 51
9.1 Emitted electromagnetic interference ............................................................................................ 51
9.2 Electromagnetic Immunity ............................................................................................................. 52
9.3 Electromagnetic Immunity ............................................................................................................. 52
9.4 Recommended safe distance ........................................................................................................ 53
10 Replacement parts and accessories ....................................................................................................... 55
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1 User instructions | 1.1 User guide
1 User instructions
1.1 User guide
Requirement
Read these instructions prior to first use to avoid misuse and prevent damage.
1.1.1 Abbreviations
Abbre‐
viation
In‐
struc‐
tions
for Use
PA
MA
TA
STK
IEC
RA
EMC
Explanation
Instructions for Use
Care instructions
Assembly instructions
Technician's instructions
Safety checks
International Electrotechnical Commission
Repair instructions
Electromagnetic compatibility
1.1.2 Symbols
See the Safety/Warning Symbols section
Important information for users and technicians
CE mark (European Community). A product bearing this mark meets the
requirements of the applicable EU directive.
Action required
1.1.3 Target group
This document is for dentists and dental office staff.
1.2 Service
Service hotline:
+49 7351 56-2800
Service.Laser@kavo.com
Please indicate the product serial number in all requests.
Additional information can be obtained at: www.kavo.com
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1 User instructions | 1.3 Warranty provisions
1.3 Warranty provisions
KaVo provides the end customer with a warranty that the product cited in the hand‐
over certificate will function properly and guarantees zero defects in respect of ma‐
terial and processing for a period of 12 months from data of purchase, subject to
the following conditions:
In the event of justified complaints due to defects or short delivery, KaVo may
choose to fulfil the terms and conditions of the warranty either by supplying a re‐
placement product free of charge or repairing the defective product. Other claims
of any nature whatsoever, in particular with respect to compensation, are excluded.
In the event of default and gross negligence or intent, this shall only apply in the
absence of mandatory legal regulations to the contrary.
KaVo cannot be held liable for defects and their consequences due to natural wear,
improper cleaning or maintenance, non-compliance with operating, maintenance or
connection instructions, calcination or corrosion, contaminated air or water supplies
or chemical or electrical factors deemed abnormal or impermissible in accordance
with factory specifications.
The warranty does not usually cover bulbs, glassware, optical components, rubber
parts and the colourfastness of plastics.
Defects or their consequences that can be attributed to interventions on or changes
made to the product by the customer or a third party are excluded from the warranty.
Claims from this warranty can only be asserted when the transfer form (copy) be‐
longing to the product has been sent to KaVo, and the original can be presented by
the operator or user.
1.4 Transportation and storage
1.4.1 Currently valid packaging regulations
Note
Only valid for the Federal Republic of Germany.
Properly dispose of and recycle the sales packaging, in accordance with the relevant
packaging regulations, through waste management businesses or recycling com‐
panies that run a comprehensive return system. KaVo has licensed its sales pack‐
aging in accordance with this directive. Please conform with the regional, public
waste-disposal system regulations.
1.4.2 Damage in transit
In Germany
If the packaging is visibly damaged on delivery, please proceed as follows:
1. The recipient of the package must record the loss or damage on the delivery
receipt. The recipient and the representative of the shipping company must sign
this delivery receipt.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use the product.
4. Report the damage to the shipping company.
5. Report the damage to KaVo.
6. You must contact KaVo before returning a damaged product.
7. Send the signed delivery receipt to KaVo.
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1 User instructions | 1.4 Transportation and storage
If the product is damaged but there was no discernable damage to the packaging
upon delivery, proceed as follows:
1. Report the damage to the shipping company immediately and no later than 7
days after delivery.
2. Report the damage to KaVo.
4. Do not use a damaged product.
Note
Failure on the part of the recipient to comply with any of the above obligations will
mean that the damage will be considered to have arisen following delivery (in
accordance with ADSp. Art. 28).
Outside Germany
Note
KaVo is not liable for damage arising from transportation.
Immediately inspect the delivery after receipt!
If the packaging is visibly damaged on delivery, please proceed as follows:
1. The recipient of the package must record the loss or damage on the delivery
receipt. The recipient and the representative of the shipping company must sign
this delivery receipt.
Without this evidence, the recipient will not be able to assert a claim for damages
against the shipping company.
3. Do not use the product.
If the product is damaged but there was no discernable damage to the packaging
upon delivery, proceed as follows:
1. Report any damage to the shipping company either immediately or no later than
7 days after delivery.
3. Do not use a damaged product.
Note
Failure on the part of the recipient to comply with any of the above obligations will
mean that the damage will be considered to have arisen following delivery (in
accordance with CMR law, Chapter 5, Art. 30).
1.4.3 Information on the packaging: Storage and transportation
Note
Please keep the packaging in case you need to return the product for servicing or
repair.
The symbols printed on the outside are for transportation and storage, and have the
following meaning:
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1 User instructions | 1.4 Transportation and storage
Transport upright with the arrows pointing upwards!
Fragile - protect against impact!
Protect from moisture!
Permissible stacking load
Temperature range
Humidity
Air pressure
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2 Safety | 2.1 Description of safety instructions
2 Safety
2.1 Description of safety instructions
2.1.1 Warning symbol
Warning symbol
2.1.2 Structure
DANGER
The introduction describes the type and source of the hazard.
This section describes the potential consequences of non-observance.
▶ The optional step includes necessary measures for hazard prevention.
2.1.3 Description of hazard levels
Safety instructions with three hazard levels are used in this document to prevent
personal and property damage.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property or mild to mod‐
erate injuries.
WARNING
WARNING
indicates a hazardous situation that can cause death or serious injury.
DANGER
DANGER
indicates a hazardous situation that can directly cause death or serious injury.
2.2 Proper use
2.2.1 General information
The user must ensure that the unit works properly and is in satisfactory condition
before each use.
This KaVo product is intended only for use in the field of dentistry. The product may
not be used for a purpose for which it was not intended.
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2 Safety | 2.2 Proper use
"Proper use" includes following all the instructions for use and ensuring that all in‐
spections and service tasks are performed.
The overarching guidelines and/or national laws, national regulations and the rules
of technology applicable to medical devices for start-up and use of the KaVo product
for the intended purpose are to be applied and complied with.
Users have a duty to:
▪ Only use equipment that is operating correctly
▪ to protect himself, the patient and third parties from danger.
▪ to avoid contamination from the product.
During use, national legal regulations must be observed, in particular:
▪ the applicable health and safety regulations.
▪ the applicable accident prevention regulations.
To guarantee constant readiness for use and maintenance of value of the KaVo
product, the recommended annual servicing must be done.
Yearly safety inspections are required.
Authorized to repair and service the KaVo product:
▪ Technicians from KaVo branches with appropriate product training.
▪ the technicians of the KaVo franchised dealers specifically trained by KaVo.
In Germany, operators, equipment managers and users are obliged to operate their
equipment in accordance with the MPG regulations.
The services encompass all the test tasks required in accordance with § 6 of the
operator ordinance (MPOperator V).
Note
The product must be cleaned and serviced according to instructions if it is not to
be used for an extended period of time.
Note
Only those accessories may be used that are approved for the device.
Information on electromagnetic compatibility
Note
Based on EN 60601-1-2 concerning the electromagnetic compatibility of electro‐
medical devices, we need to point out that:
• Medical electrical devices are subject to special precautionary measures regard‐
ing electromagnetic compatibility and must be commissioned in accordance with
the KaVo assembly instructions.
• portable and mobile high-frequency communications devices may interfere with
electrical medical devices.
See also: 9 Information on electromagnetic compatibility, Page 51
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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 the compliance of accessories, lines and transformers not
supplied by KaVo with EMC requirements of EN 60601-1-2.
Disposal
Note
Any waste which is generated must be recycled or disposed of in a manner which
is safe both for people and for the environment. This must be done in strict com‐
pliance with all applicable national regulations.
Questions on proper disposal of the KaVo product can be answered by the KaVo
branch.
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 disassembly / disposal, the product must be completely reprocessed (dis‐
infected, sterilised) according to the chapter on "Reprocessing methods".
For more information, please contact KaVo (www.kavo.com) or your dental sup‐
plier.
2.2.2 Product-specific
The GENTLEray 980 is an air-cooled diode laser with an emission wavelength of
980 nm.
The device can be used in hospitals and private practices and can be transported.
The GENTLEray is to be used by physicians and trained medical personnel under
medical supervision. The decision regarding the suitability of the unit and the se‐
lection of the corresponding treatment methods are exclusively the responsibility of
the treating physician.
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Idications
The GENTLEray 980 diode laser is suitable for use for intra- and extra-oral surgery,
including incision, excision, hemostasis, coagulation and vaporization of soft tissue,
as:
▪ Frenectomy
▪ Frenotomy
▪ Biopsy
▪ Operculectomy
▪ Implant Recovery
▪ Gingivectomy
▪ Gingivoplasty
▪ Gingival Troughing
▪ Crown Lengthening
▪ Hemostasis of Donor Site
▪ Removal of Granulation Tissue
▪ Laser-assisted Flap Surgery
▪ Debridement of Deseased Epithelial Lining
▪ Incisions and Draining of Abscesses
▪ Tissue Retraction for Impressions
▪ Papillectomy
▪ Vestibuloplasty
▪ Excision of Lesions
▪ Leukoplakia
▪ Exposure of Unerupted/Partially Erupted Teeth
▪ Removal of Hyperplastic Tissues
▪ Treatment of Aphthous Ulcers
▪ Sulcular Debridement
▪ Pulpotomy
▪ Pulpotomy as an Adjunct to Root Canal Therapy
▪ Light Activation of Bleaching Materials
Contraindications
Those patients who suffer from photodermatosis and who are photosensitive (pho‐
toallergies) may not be treated.
The preferential therapy must be carefully considered in light of the patient’s indi‐
vidual situation when they have malignant tumors and obligate precancerous le‐
sions.
Note
The manufacturer assumes no responsibility for the direct effects or side effects
that arise from therapeutic or surgical or use of the system. The sole responsibility
lies with the medical personnel.
Micropulse mode
The micropulse mode increases the efficiency of cutting in soft tissue. In this mode,
the laser emits micropulses at a constant peak power of 12 W and a fixed pulse
length of approximately 25 µs. The average power is varied by changing the length
of pauses between the individual pulses.
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The average power is adjusted using the power setting. The resulting average power
is shown in the power display.
Note
Working in burst mode is recommended to prevent the tissue from overheating in
micropulse mode.
① Power setting
② Display micropulse mode (inactive)
③ Average power
Note
The average power is also affected by varying the pulse and pause times.
CAUTION
Unintentional use of micropulses
Tissue damage
▶ Micropulse mode ② must be manually activated if its use is desired.
▶ Before each treatment, the user must check whether the micropulses are active
or inactive.
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2 Safety | 2.3 Safety instructions
CAUTION
Micropulses emit high peak energy to the tissue.
Tissue damage
▶ Use this mode with care.
▶ Do not use micropulses to bleach teeth or for decontamination.
2.3 Safety instructions
2.3.1 General information
CAUTION
A hazard can arise from untrained persons who use the device
Injury to the patient or operator
Damage to the unit
▶ The device may only be used by persons who can properly handle it due to
their training or knowledge and practical experience. Informative courses are
also offered by KaVo Dental GmbH.
▶ The proper operation of the device should be confirmed by the signature of
trained person in the medical device book.
▶ Become thoroughly familiar with the instructions for use.
Note
The manufacturer assumes no liability for damage arising from untrained persons.
CAUTION
Hazard from electrical power
Electrical shock
▶ Do not open any protective covers.
▶ Do not place any liquids on the device.
▶ If liquids penetrate the device, immediately turn it off with the laser emergency
off switch, pull the power plug, and notify customer service.
Note
All optical components, especially the parts of the laser guidance system, must be
handled with great care and protected from dust and dirt.
Do not touch optical surfaces.
2.3.2 Product-specific
Note
The GENTLEray 980 meets the requirements of the German Medical Device Law
(MPG) and hence the EC directive for medical devices (93/42/EEC).
The GENTLEray 980 is a class IIb according to the above cited directive.
EC Directive 93/42 and the Medical Device Operation Ordinance (MPBetreibV) re‐
quire operators, supervisors and users of Class IIb devices to observe a series of
safety precautions. In particular, such devices may only be operated in accordance
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with the generally recognized rules of technology and occupational health protection
and accident protection regulations.
With medical lasers, the current version of the accident prevention regulation, "Laser
beam," by the German Institution for Statutory Accident Insurance and Prevention
must be observed. In addition, the user must keep a medical device log.
Hazards of laser beams
CAUTION
Additional for the use in Canada
The instrument must be installed and operated to CAN/CSA-Z386-92:
▶ Laser safety in health care facilities.
CAUTION
Hazard from direct or diffuse laser radiation (class 4 laser)
Irreversible eye damage
Explosion and fire hazard
▶ The conditions of laser beam accident prevention regulation BGV B2 must be
observed (only applicable for Germany). The respective national accident pre‐
vention regulations apply to other countries.
CAUTION
Laser-related fire hazard
Surfaces can absorb laser energy. This can cause the surface temperature to rise
and ignite the material.
▶ Never use the GENTLEray 980 in explosive areas.
▶ Never use flammable substances for anaesthesia, preparing the treatment or
cleaning and disinfecting the instruments.
▶ If solvents and flammable liquids are used to clean and disinfect, make sure
that they evaporate before working with the laser.
▶ Never use oxidation gases such as dinitrogen oxide (N2O) and oxygen.
▶ Be particularly careful when using oxygen since oxygen can increase the
strength and extent of a fire.
▶ Only store a minimum amount of flammable materials in the treatment room.
▶ If flammable materials are necessary for treatment, wet them.
▶ Keep articles of clothing away from the treatment unit.
▶ Keep a small fire extinguisher and water in the treatment room.
▶ Note that materials such as cotton can be flammable during normal laser use
when they are saturated with oxygen.
▶ Note than endogenous gases can explode.
CAUTION
Infection danger from laser smoke
Laser smoke can contain live tissue particles from irradiated tissue.
▶ Used a smoke exhaust system with a filter when vaporising or during ablation.
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Notification requirement
Before the laser is initially operated, the professional association and authorities
responsible for occupational safety must be notified.
Laser safety officer
A laser safety officer must be appointed in writing who is responsible for at least the
following tasks (country-specific):
▪ Monitoring the operation of the laser device
▪ Offering the operator assistance with safe operation and the necessary safety
measures
▪ Helping safety personnel to perform their tasks including instruction in important
facets of laser safety
Signs in the laser area
During operation, the area in which the maximum permissible radiation can be ex‐
ceeded, the "laser area" must be delimited and identified by a laser warning sign.
At the entrances, the operation of the laser must be announced by warning lights
and the triangular, yellow laser warning sign.
The NOHD (Nominal Ocular Hazard Distance) from the laser is so big that the entire
area in which the laser is used must be considered the laser area.
An additional laser warning sign must be provided by the manufacturer with each
laser system. We recommend affixing a sign to the entrance of the laser treatment
room to warn entering persons of the laser in the room.
Personal eye protection
All persons who are in the laser room during treatment must wear protective laser
goggles. The laser goggles must correspond to the currently valid version of the
German guideline DIN EN 207 "Personal eye protection, filters and eye protection
devices against laser beams" and must have the properties cited in the technical
data.
See also: 3.2 Technical Data, Page 17
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CAUTION
Hazard from direct and indirect laser radiation
Serious eye and skin damage
▶ Never look directly into the outlet of the handpiece or glass fibre bundle, even
with protective glasses.
▶ Identify the laser area so that no unauthorized person will enter it during treat‐
ment.
▶ Restrict access to the treatment room to the dentist and assistant.
▶ Cover windows and openings to the treatment room to prevent the laser from
accidentally exiting.
▶ Only direct the active laser to the treatment area.
▶ There may be no metal objects such as clocks or chains in the work area.
▶ No reflecting objects (instruments or holders) may be in the work area.
▶ Make sure that employees know how to turn off the laser in an emergency.
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3 Product description | 3.1 GENTLEray 980
3 Product description
3.1 GENTLEray 980
Device front
① Display with touch screen
② Laser warning light
③ Handpiece holder, right
④ Laser with emergency-off
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⑤ Key-operated switch
⑥ Fibre output with SMA socket
⑦ Vent
3 Product description | 3.2 Technical Data
Rear of device
① Connection for external contact (door
contact)
② Foot switch
③ Mains switch
④ Mains fuse
⑤ Power connection
3.2 Technical Data
General information
Beam guide
Flexible glass fibre
Display
LCD screen
Instructions for use
Touchscreen
Cooling
Internal air cooling controlled by output
power
Door contact connection
Potential-free contact 5 VDC/max. 20
mA (TTL)
Mode
With interruptions: 20 minutes operation,
10 minute pause
Dimensions (W x L x H)
18 x 26 x 17 cm
Weight
approx. 3.5 kg
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3 Product description | 3.2 Technical Data
Electrical system
Mains supply
100 to 240 V AC ± 10%, 50/60 Hz, max.
200 VA
Electrical protection class
I
Protection class for the footswitch
IP X8
Classification
Classification according to MPG
II b
Protective class of application part
BF
Laser specification
Laser type
Diode laser
Wavelength
980 ± 10 nm
Laser class
4 (D980 L3 protective glasses are better
must be worn)
Laser output
0.4 to 6 W distal
Mode
CW, single pulse, pulse sequence
Pulse length
Macropulse: Can be adjusted between
25 ms and 100 s; Micropulse: 25 µs fixed
Pulse spacing
Can be adjusted between 25 ms and 5 s
(only with micropulse)
Pulse repetition rate
2 to 20 kHz, only micropulse
Power tolerance
Max. ± 20%
Spot diameter
Bare fibre 300 µm and 200 µm; bleach‐
ing handpiece 5 mm
Beam expansion (half-angle)
Bare Fibre 220 mrad
Nominal ocular hazard distance
Bare fibre 2.5 m; handpiece 2.5 m;
bleaching handpiece 5.1 m
Laser type
Collimator laser (laser diode)
Wavelength
635 nm
Laser class
2
Laser power
< 1 mW, adjustable
UMDNS No.
12-299, therapeutic
Operating conditions
Ambient temperature
15°C to + 35°C
Relative humidity
< 70 %
Air pressure
700 to 1060 hPa
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3 Product description | 3.3 Scope of delivery
Transportation and storage conditions
Ambient temperature during transporta‐ -20℃ to +55℃
tion and storage
Relative humidity
10% to 90%
Air pressure
800 hPa to 1060 hPa
3.3 Scope of delivery
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪
▪
Base unit
Power cable
Foot switch
Door contact plug
Keys (2)
Handpiece holder, right
Fibre holder
Laser safety goggles (3)
Instructions for Use
Laser warning label
Accessories
– Bare fibre 300 µm core diameter
– Handpiece for bare fibre including cannulas (6)
3.4 Signage
3.4.1 Rating plate
Type
REF
SN
Device type GENTLEray 980
Material number, version
Year of manufacture - serial number
Read and note the content of accompanying documents.
Mode:
Operating time: 20 minutes
Pause time: 10 minutes
Classification
Type BF application part
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3 Product description | 3.4 Signage
Disposal instructions,see also:Intended use
CSA C/US mark
CE mark according to EC Directive 93/42 for medical devices
Read and note the content of accompanying documents.
3.4.2 Warning and informational signs
The laser unit has various warning and informational signs on the front and back.
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3 Product description | 3.4 Signage
Mat.
No.
①
Figure
Description
Laser with emergency-off
②
Laser warning sign
③
Caution: Hazard to fingers contact‐
ing moving parts.
④
Note: Observe the accompanying
documentation. The user is advised
to carefully read the instructions for
use before using the system.
⑤
Rotary controller for the rinse flow
⑥
Laser warning sign
⑦
Mains fuse, A 2.0 T type H
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3 Product description | 3.5 Function description
Mat.
No.
⑧
Figure
Description
Laser output at the end of the fiber
applicator
⑨
Door contact
⑩
Footswitch
3.5 Function description
Laser
a semiconductor diode laser is used in the device. In diode lasers, the beam is
generated by directly converting the supplied electrical current into laser light.
Cooling
The laser is cooled with the surrounding air. Internal coolant water is not necessary.
Several temperature sensors ensure safe operation.
To ensure cooling, the device should only be operated under the proper environ‐
mental conditions. The ambient air should be low in dust. A minimum distance of 10
cm should be maintained from solid objects at the cooling openings (such as walls).
Modes
The device operates in continuous mode (cw) and pulse mode (single pulse, se‐
quential pulse). It is designed for temporary use for up to 20 min of uninterrupted
operation. Then the device must pause for 10 minutes.
Control
A microcontroller system is responsible for the monitoring and control of all output
parameters and safety devices of the unit.
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3 Product description | 3.5 Function description
Operation
The device is operated using a touchscreen. An LCD display is provided with text
instructions. The laser output, pulse length and pulse pauses are adjustable. In ad‐
dition to the selected parameters, additional data such as the laser mode (standby
or ready), the applied laser time, and text messages in the case of malfunctions are
displayed. The laser is triggered with a foot switch or hand switch.
Beam transmission system
The laser beam is transmitted from the device to the site of treatment by means of
a flexible fibre-optic conductor. fibre-optic conductors should not be bent too much
to prevent damage. in addition, the free fibre ends may not directly touch the contact
surface of the bare fibre.
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4 First use | 4.1 Installation instructions
4 First use
4.1 Installation instructions
▶ Observe the following instructions. Nonobservance can destroy the device.
Note
After installation and each time the device's location changes from a cold to warm
environment with a difference in temperature of more than 5°C, the unit must be
acclimatized unpacked before use (laser operation)：
- for at least two hours in case of a temperature difference up to 10°C
- for at least four hours in case of a temperature difference up to 15°C
- for at least 8 hours in case of a temperature difference up to 20°C
Note
For the device to effectively cool, a minimum distance of 10 cm must be maintained
between the sides of the rear wall of the device and the wall.
CAUTION
Electrical voltage too high
Damage to the system
▶ Do not connect the contacts for remote locking and the footswitch to the mains
voltage.
Note
The contacts for the remote locking and the footswitch may never be connected to
mains power since this could seriously damage the system.
4.2 Unpack the device
▶ Acclimatize the device when packaged.
See also: 4.1 Installation instructions, Page 24
▶ Remove the device from the packaging and check if all the components are
present.
See also: 3.3 Scope of delivery, Page 19
▶ Store the packaging so that the device can be shipped securely at a later time.
▶ Turn on the device without connecting an applicator, and let it warm up for at
least 30 minutes.
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4 First use | 4.3 Connect the door contact
4.3 Connect the door contact
The connection for the door contact is on the back of the unit. The door contact is
potential-free at a max. 5 VDC and max. 20 mA.
If the remote lock contact is connected to an external contact (such as the door
contact), it can prevent the laser beam from being generated when the door contact
is opened.
The laser can only be operated when the contact is closed. The laser treatment
beam is automatically turned off when the door is opened to the laser area so that
persons entering the room are not harmd.
The supplied connection plug is factory-equipped with a short connection.
CAUTION
Electricity
Electrical shock
▶ First turn off the device and unplug it before installing the remote lock contact.
▶ Remove the short connection and connect it to the remote lock contact of the
external contacts.
Note
The external contact must be potential-free and designed for at least 12 V DC and
100 mA.
4.4 Connect the footswitch.
▶ Insert the footswitch plug all the way in the footswitch connection.
▶ Secure the footswitch plug by turning the cover to the right.
▶ Place the foot switch directly next to the device.
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4 First use | 4.5 Connect the bare fibre
4.5 Connect the bare fibre
Note
Also observe the accompanying instructions for use for the GENTLEray 981 hand‐
piece.
▶ After opening, carefully remove the bare fibre from the package and check for
damage (such as kinks).
▶ Carefully remove the protective cap of the SMA plug (bare fibre). Hold the metal
plug in your hand and do not pull on the fibre.
▶ Screw off the protective cap ① at the device.
Note
To protect the optical components in the device, the SMA socket in the device must
always be closed (with a bare fibber or protective cap ①).
Note
Only use fibres with clean fibber ends.
See also: Instructions for use for the handpiece of the GENTLEray 981
Note
The protective cap hose can be ordered under Mat. No. Mat. no. 0.065.5188 as a
replacement part.
▶ Insert the SMA plug of the bare fibre completely into the SMA socket on the front
of the device, and screw the union nut tight. Do not twist the fibres!
Note
The fibre plug must be correctly screwed into the SMA socket to keep the light fibre
from premature aging. Check this by moving the plug back and forth in an axial
direction near the kink protection. Axial play means that the bare fibre is not cor‐
rectly connected to the unit.
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4 First use | 4.6 Connect the unit to the electrical power supply
▶ Turn on the device, and check the optical quality of the fibres using the red target
beam laser spot at the end of the fibre.
The edge of the target beam laser spot may not be "frayed." A frayed edge
indicates defects or soiling of one or both fibre ends.
See also: Instructions for use for the handpiece of the GENTLEray 981
CAUTION
Danger of contamination
Damage to the device and bare fibre
▶ Always seal the coupling surface of the bare fibre and the SMA socket with the
proper protective caps.
Optionally retrofitable hose roller and handpiece holder, left
Note
When using a second handpiece (such as the optional bleaching handpiece
(Mat. no. 1.005.2895), KaVo recommends using a second mounted hose roller
(Mat. no. 1.007.0160) with the additional handpiece holder, left
Mat. no. 1.006.9284.
4.6 Connect the unit to the electrical power supply
A single-phase socket is required with at least a 200 VA fuse (type B, slow-blow).
See also: 3.2 Technical Data, Page 17
Requirement
The main switch of the unit must be in "0" position.
27/55
4 First use | 4.6 Connect the unit to the electrical power supply
▶ Insert the power cable at the power supply input at the back of the device
▶ Connect the other end of the power cable to the power supply.
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5 Operation | 5.1 Safety equipment
5 Operation
5.1 Safety equipment
The device has various safety devices that prevent improper use and unintentional
activation of the system. Everyone who uses the laser or helps handle it should be
familiar with these devices.
Note
Various safety signs are posted on the device. These signs always have to be
legible, and they must be replaced immediately when their damaged.
Note
The laser emission is indicated by a tone during the emission.
5.1.1 Turn off the device with the power switch
▶ Turn the power switch to OFF position (0) to turn off the power to the device.
5.1.2 Turn on the device with the key-operated switch
Note
The power switch must be in position I for the key-operated switch to be actuated.
The system is activated with the key-operated switch. Only authorised persons who
have access to the key can start the system. The key-operated switch can only turn
the system on when the laser emergency-off switch has not been pressed.
▶ Always remove the key after turning off the device.
▶ The key may only be kept by unauthorized persons.
5.1.3 Turn the laser off with the emergency-off switch
The laser emergency-off switch serves to turn off the laser system immediately in
an emergency. It should only be used in emergencies, that is, when it is necessary
to immediately stop the laser emission.
▶ Press the laser emergency-off switch to turn off the laser system immediately.
▶ After the emergency, turn the switch to the right until it springs out.
5.1.4 Turn the laser beam on and off with the footswitch
User the footswitch to trigger laser emission.
▶ Place the foot switch next to the treatment site.
▶ Press the foot switch for actuation.
▶ Release the footswitch to stop the laser emission.
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5 Operation | 5.2 Switching the machine on
5.1.5 Standby mode
The Standby mode prevents the laser from being unintentionally or accidentally ac‐
tivated. When the system is in Standby mode, the laser cannot be emitted. The user
can only activate the laser beam when the device is in "Ready" mode.
See also: 5.6 "Treatment" menu, Page 36
The device is in "standby" mode in the following instances.
▪ After the device is first started.
▪ When the user presses a button to select laser parameters.
▪ When the system has been in "Ready" mode for a long time and the laser has
not been activated.
▪ When the user presses the "Ready" button while the device is in "Ready" mode.
5.1.6 Automatic shutoff
As soon as the problem arises, the system automatically switches to safe mode:
▪ The electrical beam shutter closes.
▪ The diode beam is interrupted.
▪ The footswitch is deactivated.
▪ An error message appears on the screen that identifies the specific error.
See also: 8 Troubleshooting, Page 49
5.2 Switching the machine on
Before turning the device on, the following is required:
▪ The voltage on the rating plate must be the same as the local mains voltage.
▪ The device power plug is connected to the correct power supply.
▪ The SMA plug of the applicator (bare fibre or fibre with handpiece) is plugged
into the SMA socket of the fibre output on the front of the device and screwed
tight.
▪ The footswitch plug is properly connected to the foot switch socket on the back
of the device and screwed tight.
▪ The warning lights are mounted at the entrance to the laser area and are turned
on (if necessary).
▪ All the safety measures have been checked.
▶ The main switch on the rear of the device is turned on (I).
▶ Make sure that the laser emergency-off switch is deactivated (not pressed).
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5 Operation | 5.3 Main menu
▶ Insert the key into the key-operated switch, and turn it clockwise to the stop.
① Off
② Start
③ On
The start screen is shown on the display while the device automatically subjects
important and safety-relevant components to a test.
After a few seconds, the main menu appears on the display.
▶ If the device does not react after the key-operated switch is turned, make sure
that:
▪ the laser emergency off button is unlocked (by turning the red pushbutton to the
left until the lock releases and the button springs out).
▪ the main power switch on the back of the device is turned on.
▪ the main fuse on the back of the device is okay.
Check the fuse
▶ Turn the device off.
▶ Pull out the fuse box using a watchmaker's screwdriver.
▶ Check the fuse and replace it if necessary with a 2.0 A microfuse for 250 V~ with
disconnecting characteristic H (GT 2.0 A H).
5.3 Main menu
The device has a touch screen.
Functions can be selected and parameters can be set using the key fields on the
display. If it has not been deactivated, an acoustic signal sounds when you press a
key.
See also: 5.4 "Settings" menu , Page 32
31/55
5 Operation | 5.4 "Settings" menu
The parameters for the indications can be set with the "Plus" and "Minus" keys, or
"Left arrow" and "Right arrow". You run to the parameters by holding down the key.
The main menu has the following selection:
▶ Press the "Indication list" key to open the "Indication list" menu.
You can select indications, change treatment parameters and save them in the
"Indication list" menu.
See also: 5.5 "Indication list" menu, Page 34
or
▶ Press the "Direct start" key to open the "Treatment" menu.
The treatment parameters of the set indication are displayed. The device is in
"Standby" mode.
See also: 5.6 "Treatment" menu, Page 36
or
▶ Press the "Tool" key to open the "Settings" menu.
In the "Settings" menu, you can set special functions such as display settings or
signal tones, etc.
See also: 5.4 "Settings" menu , Page 32
5.4 "Settings" menu
5.4.1 Open the "Settings" menu
▶ Press the "Tool" key in the main menu.
The "Settings" menu is displayed.
32/55
5 Operation | 5.4 "Settings" menu
Pos.
no.
①
②
③
Name
Function
Contrast
Language
Pilot beam
④
Beep
Brightness of the display in percent
Language selection
Brightness of the target beam in per‐
cent
Acoustic signal each time a key is
pressed.
The circle being solid indicates that
the function is activated.
5.4.2 Change settings
▶ Press the "Plus" or "Minus" key to change the brightness of the screen or the
pilot beam.
▶ Press the "Left arrow" or "Right arrow" key to select the language.
▶ Press the "Signal tone" key to activate or deactivate the acoustic signal.
▶ Press the "OK" key to save the settings and close the menu.
or
▶ Press the "Stop" key to close the menu without saving the changed settings.
Change the display colours
The user can select from various colour schemes for the screen display.
▶ In the main menu, press the "Tool" key.
The "Settings" menu appears on the display.
▶ In the "Scheme" field, use the + and - keys to switch between the individual colour
schemes.
▶ Select the desired colour scheme by pressing OK.
▶ Adjust the brightness in the Contrast field by using the + and - keys.
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5 Operation | 5.5 "Indication list" menu
Note
It takes about 30 seconds to adapt the colour scheme. The unit shuts off the screen
during switchover. The laser warning light also flashes.
Do not turn off the device while changing the colour scheme. When the device is
turned off while the colour scheme is changing, it will take about 30 seconds more
to start the device (while the screen in blank).
5.5 "Indication list" menu
5.5.1 Select indication
▶ Press the "Indication list" key in the main menu.
The "Indication list" menu is displayed.
▶ Press the name of the indication, or scroll with the Up or Down keys to select
the indication.
The selected indication name is emphasised.
Press the "Double arrow up" or "Double arrow down" keys to scroll through the
display page.
The following selection keys are available in the "Indication list" menu:
Key
Name
Information
Operation
Information on the selec‐
ted indication is displayed.
Program
The display changes to the
"Program" menu. In the
"Program" menu, you can
change and save the pa‐
rameters of an indication.
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5 Operation | 5.5 "Indication list" menu
Key
Name
Stop
OK
Operation
The display switches to the
last displayed menu with‐
out accepting the selected
indication.
The selected education is
accepted. The display
changes to the "Treat‐
ment" menu.
5.5.2 Display information on the indication
▶ Press the "Information" key.
Information on the selected indication is shown in the display.
5.5.3 Change and save parameters of an indication
▶ Press the "Program" key in the on "Indication list" menu.
The "Program" menu is displayed.
▶ Changing desired parameters.
See also: 5.6.2 Changing parameters, Page 36
35/55
5 Operation | 5.6 "Treatment" menu
▶ Press the "Save" key to save the changed parameters.
or
▶ Press the "Stop" key to returning to the "Indication list" menu without saving the
settings.
5.6 "Treatment" menu
5.6.1 Open the "Treatment" menu
▶ Press the "Direct start" key in the main menu.
The "Treatment" menu is displayed. The device is in "Standby" mode. All the
parameters of the selected indication are displayed and can be changed.
Press of the "Fold in" and "Unfold" buttons to display additional parameters.
5.6.2 Changing parameters
The following functions and parameters are displayed and can be changed in the
Treatment menu:
36/55
5 Operation | 5.6 "Treatment" menu
Display/key
Name
Name of indication
Power display
Power
"Continuous operation"
mode
"Pulse sequence" mode
"Individual pulse" mode
Pulse length
Pulse pause
Laser time
37/55
Function
Press the "Indication list"
key to display the "Indica‐
tion list" menu.
Display of:
Pulse power Pm and
mean pulse power Pø
The set value corresponds
to the cw or pulse power
Continuous laser emission
at the set laser power as
long as the foot switch is
pressed. The laser emis‐
sion is interrupted when
the foot switch is released.
Emission of a series of pul‐
ses at the set power, pulse
length, and pulse pause as
long as the foot switch is
pressed. The pulse series
is transmitted without in‐
terruption until the foot
switch is released.
Pressing the foot switch
causes a single pulse to be
emitted at the set power
and pulse length. The la‐
ser is shut-off automatical‐
ly at the end of the pulse.
Even if the user continues
to press the foot switch.
The foot switch must be
pressed again to get an‐
other pulse.
Can be set only in pulse
sequence and single pulse
modes. The pulse length is
the duration of the emitted
pulses while the foot
switch is pressed.
Can be set only in pulse
sequence mode. The
pulse distance is the peri‐
od of time between two
consecutive laser pulses.
After the set time has ex‐
pired, the laser shuts-off
automatically.
The laser can be interrup‐
ted by releasing the foot
switch.
The timer is reset when
you switch to "Standby"
mode.
5 Operation | 5.7 Treatment
Display/key
Name
Micropulse mode
Help
Function
The circle being filled in or
the key being dark indi‐
cates that this mode is
turned on.
Information on the selec‐
ted indication is displayed.
Cancel
The most recently selec‐
ted display is shown.
Laser activation
The device switches to
"Ready" mode.
When the button has a
background of a different
colour, the device is in
"Ready" mode. When the
button has a default colour
background, the device is
in "Standby" mode.
5.7 Treatment
5.7.1 Check door contact
Requirement
The door contact is installed.
▶ Open the door.
▶ Press the "Ready" button.
An error message appears on the display.
▶ Confirm the error on the display.
▶ If an error message does not appear on the display, eliminate the door contact
malfunction, or secure the door in another manner.
5.7.2 Make the laser ready
Open "Ready" mode
CAUTION
Hazard from direct or scattered laser radiation
Serious eye damage
▶ Make sure that all of the people in the room including the patient are wearing
safety goggles.
38/55
The following safety precautions must be rechecked:
▪ All laser safety precautions have been taken.
▪ The fibre-optic conductor and handpiece are correctly connected.
▪ The aiming beam is visible on the application site.
▪ The handpiece or the end of the bare fibre is placed on the desired treatment
site.
The aiming beam indicates the treatment site and the approximate spot diameter of
the therapy beam. Since the aiming beam follows the same path through the beam
guidance system as a therapy being, the aiming beam is a good way to check the
correctness of the beam guidance system.
CAUTION
Burning hazard from damaged bare fibre
If the bare fibre is damaged, the cannula may become heated and cause burns.
▶ Monitor the optical system (especially the bare fibre) before and during use by
noting the aiming beam quality.
CAUTION
Danger of aspirating fragments of the bare fibre
When the bare fibre breaks, individual parts of the fibre can split off and be aspi‐
rated.
▶ Make sure the the bare fibre is not damaged before each treatment by pulling
gently on it.
▶ Press the "Ready" key in the "Treatment" menu.
The device is in "Ready" mode.
The laser warning appears on the display.
The device is ready to release the treatment beam.
CAUTION
Unintended triggering of the laser beam
Tissue damage
▶ Only place your foot on the foot switch at the start of treatment.
▶ If the laser beam is unintentionally released, immediately remove your foot
from a foot switch.
39/55
Changing parameters in "Ready" mode
▶ Changing desired parameters.
The device automatically switches to "Standby" mode.
▶ Press the "Ready" button.
The device is in "Ready" mode.
The laser is ready.
Turn the device off in an emergency
▶ Forcefully press the laser emergency-off switch.
The laser is immediately deactivated.
▶ After rectifying the emergency situation, turn the laser emergency off switch
slightly to the left into normal position.
The device is functional.
5.7.3 Release the treatment beam
CAUTION
Danger of contamination from living particles
Infections
▶ Utilised handpieces must be sterilised every time before they are used on a
patient!
CAUTION
Unintended effect of the laser beam
Injury hazard
▶ Observe all the regulations concerning protection from unintended effect.
▶ Only trigger the laser when the pilot beam works properly, and the fibre or the
handpiece is correctly aligned on the skin to be treated.
▶ Immediately press the laser emergency off switch when a hazardous malfunc‐
tion occurs.
CAUTION
Burning hazard from hot cannula
Burning hazard!
▶ Keep the cannula from touching soft tissue since this can become hot when
damaged and cause burns.
▶ During treatment, watch for any discolouration of the cannula which could in‐
dicate overheating. If the cannula changes colour, stop treatment.
40/55
5 Operation | 5.8 Switching the machine off
CAUTION
Interruption and deflection of the laser beam by reflecting objects
Tissue damage from stray emissions
Insufficient irradiation of the treatment site
▶ Do not aim the beam near reflecting objects. Note that objects with a dull sur‐
face can also reflect the laser beam.
▶ Press the foot switch to actuate the treatment beam.
The treatment beam is released with the set parameters.
If the timer was not set to continuous, it automatically counts down the emission
time and turns off the laser when the set time is over.
The following acoustic and visual signals indicate laser emission:
– Warning tone
– Flashing laser warning sign on the display
– Yellow flashing laser emission display on the right next to the display.
Note
If the symbols "+++" and "---" appear below the laser performance display, the
device has detected a deviation of more than 20% from the initial values. If these
symbols remain, contact service.
Interrupt laser emission
▶ Remove your foot from the foot switch to interrupt treatment.
End treatment
▶ Press the "Ready" button to switch to the safe "Standby" mode.
In this mode, you cannot accidentally trigger the laser beam.
After a long period of inactivity in "Ready" mode, the device automatically switches
to "Standby" mode.
5.8 Switching the machine off
CAUTION
Unauthorized use of the machine
Injury hazard
▶ Never leave the machine unattended while it is turned on.
▶ Turn the power switch to OFF position (0) to turn off all the power to the device.
▶ After turning off the machine, make sure that the key is removed and stored in
a safe place.
▶ Press the "Ready" button to switch to the "Standby" mode.
41/55
5 Operation | 5.8 Switching the machine off
▶ Turn the key-operated switch all the way counterclockwise to turn off the laser.
▶ Turn the power switch on the rear of the device to OFF (0).
▶ Store the fibre and handpiece in a safe place and check for soiling. Immediately
remove any dirt.
42/55
6 Care | 6.1 Machine cleaning and care
6 Care
6.1 Machine cleaning and care
Note
Only when the device is turned off.
When cleaning, make sure that no liquid enters the device since it can cause mal‐
functions.
Note
Directly spraying switches such as key-operated switches can cause long-term
contact problems. In such locations, it is better to spray a cloth with disinfectant
and wipe the site to be disinfected.
Note
In general, make sure only to use disinfectants that are approved for use on painted
and plastic surfaces in dental and medical environments.
Damage can arise to paint surfaces as well as plastics due to the variety of medi‐
cines and chemicals used in the dentist's practice.
Tests have shown that no one hundred percent surface protection can be found for
all materials that are available in the marketplace.
As damage to the surface is very much dependent on the exposure time, it is vital
that the affected areas are wiped down immediately with a moist cloth.
6.1.1 Manual cleaning
Any residue arising from disinfectants can be cleaned to a certain degree on painted
and plastic surfaces with neutral, nonabrasive rinses and cleansers.
New painted surfaces that do not cause water to bead can be cleaned with water
and nonabrasive, mild cleansers.
Distressed paints with less gloss that are darker and unclear are first cleaned as
described above and preserved with conventional paint care agents. Apply the paint
care product with a lint-free cloth in a circular motion. Then repolish with a pad or
cloth until the surface shines.
6.1.2 Machine cleaning
Not applicable.
43/55
6 Care | 6.2 Machine disinfection
6.2 Machine disinfection
6.2.1 Manual disinfection
Note
Only when the device is turned off.
The most important requirement is to use the disinfectant according to the manu‐
facturer's instructions.
Use of alcoholic disinfectants:
Disinfectants are obtainable in a wide range of concentrations.
KaVo recommends the following products on the basis of material compatibility. The
microbiological efficacy must be ensured by the products' manufacturer.
▪ Microcide (Schulte & Mayer)
▪ Dürr FD 322 (Dürr Dental)
Follow the manufacturer's instructions for use regarding application.
▶ Disinfect surface by wiping with a soft cloth and approved disinfectant.
Note
KaVo is not liable if preparations other than those listed are used.
6.2.2 Machine disinfection
Not applicable.
6.3 Sterilisation in a steam steriliser
6.3.1 Sterilisation
CAUTION
Product damage due to improper sterilisation.
Damage to the sterile product.
▶ No hot air sterilisation, no chemical cold sterilisation, do not sterilise with eth‐
ylene oxide!
CAUTION
Moisture.
Non-sterility.
▶ Ensure dryness. Autoclaves with a after-vacuum ensure dryness! In addition,
drying can be accelerated through a 10 minute drying phase with the autoclave
door open.
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6 Care | 6.3 Sterilisation in a steam steriliser
CAUTION
Product damage
Contact corrosion
▶ Remove the sterilised item from the autoclave immediately after sterilising.
Sterilise the mounted roll of tubing and the handpiece support.
Note
The mounted hose roller ① and the handpiece holder, right ② or handpiece holder,
left Mat. no. 1.006.9284) must be prepared. Preparation should directly precede
use.
▶ Sterilise the mounted hose roller ① and the handpiece holder, right ② or hand‐
piece holder, left at 134°C ± 1°C and 3.04 bar for at least 4 minutes (up to a max.
138°C).
45/55
7 Maintenance and safety checks | 7.1 Regularly perform safety checks
7 Maintenance and safety checks
7.1 Regularly perform safety checks
CAUTION
Incorrect setting of the therapy laser
Tissue damage
▶ Have customer service check the output at least once a year.
CAUTION
Wrong operation, service, testing and calibration equipment
Hazardous exposure to radiation
▶ Only use the operation, service, testing and calibration equipment cited in the
instructions for use. Other procedures may not be used.
Note
Only KaVo or technicians trained by KaVo may perform service, repairs or changes.
▶ Regularly perform safety checks, and calibrate once a year.
▶ Enters the results of the checks and calibration in the medical device log.
Interval
Before each use,
weekly
weekly
Test procedure
examine the fibre-optic
handpiece.
Check the outside of the
machine.
Test goal
The fibre handpiece must
be in proper working order.
The cable connections
must be undamaged and
firmly plugged in.
Examine the cooling sys‐ All ventilation grates of the
tem.
cooling system must be
unclogged.
7.2 Scope of the annual safety checks
Requirement
● Observe national regulations in their respectively valid version
● At least the following tests must be performed in the indicated sequence.
▶ Perform visual inspection of the machine and its accessories.
▶ Have customer service check the actual output of the laser module at the hand‐
piece and had recalibrated if necessary.
▶ Check functions.
Note
Only trained service personnel may calibrate the laser output.
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7 Maintenance and safety checks | 7.2 Scope of the annual safety checks
7.2.1 Bases
Note
Follow the instructions in the instructions for use, chapter 2: Safety.
According to VDE 0751-1 / IEC 62353:
▪ Annual safety check
▪ Device type IIb
▪ Protection class I
▪ Mobile device
▪ Type BF general
▪ Measurement according to EUL
▪ Measurement of EPL
KaVo supplies a medical device record in which you make an inventory listing and
record the main master data of the medical device. www.kavo.com/De/produkte/
praxis_einrichtungen/
The following measurements must be documented:
▪ Visually inspect the medical device and accessories
▪ Check the ratings of fuses that are accessible from outside.
▪ Protective conductor tests in accordance with VDE 0751-1/ IEC 62353
▪ Leakage current measurements in accordance with VDE 0751-1/ IEC 62353
▪ Medical device function test with reference to accompanying documentation
Note
The main switch of the device must be turned on during measurement.
7.2.2 Implementation
Measuring the protective conductor resistance
The following thresholds must not be exceeded: < 0.3 Ω with mains cable and < 0.2
Ω without.
▶ Touch the test tip to the rear wall of the housing.
47/55
7 Maintenance and safety checks | 7.3 Preparations for changing location and transport
Measurement EUL (substitute devices discharge current) according
to VDE 0751-1 / IEC 62353
The limit of < 1 mA must not be fallen below.
L
~
N
MD
Measurement EPL (patient discharge current) according to VDE
0751-1 / IEC 62353
The limit of 5 mA must not be exceeded.
L
N
MD
7.3 Preparations for changing location and transport
▶
▶
▶
▶
Pull the mains plug.
Disconnect the fibres of the handpiece.
Disconnect the foot switch.
Pull the door contact plug.
When transporting over long distances in a car or other means of transportation, it
is best to place the machine in a carrying case.
48/55
8 Troubleshooting | 8.1 Malfunctions with error messages
8 Troubleshooting
CAUTION
Life-threatening voltage when the machine is open, even when the plug is pulled
Life-threatening
▶ Do not perform repairs yourself.
In case of general malfunctions, the display shows a malfunction message with text
instructions. The touch panel cannot be used for actuation. An acoustic reaction is
also not generated when it is touched. The machine remains in this state until it is
turned off. If the error remains after the machine is turned back on, call service.
In case of malfunctions affecting safety, the device turns off within a few milliseconds
without providing a message on the display. If this is the case, or if a malfunction
rises that is not described in these instructions for use, turn off the machine by pulling
the power plug.
8.1 Malfunctions with error messages
The GENTLEray 980 is equipped with alarm systems. When these alarms are trig‐
gered, the system switches to safety mode, and laser emissions are stopped.
▶ Eliminate the error as described in the troubleshooting table.
▶ If the malfunction continues, contact KaVo Service. (Note the name of the mal‐
function and the malfunction code.)
Malfunction
Temperature too low
Code 502
Cause
Remedy
The temperature of the laser mod‐ ▶ Let the machine acclimatise until
ule is too low
it reaches its minimum operating
temperature.
▶ Then turn the machine back on.
Temperature too high
Code 501
Temperature of the laser module is ▶ Let the machine cool in Standby
too high
mode.
▶ Reactivate the laser after a
while.
Communication
Code 3xx
Internal data exchange error
▶ Turn the machine off and on.
Setup
Code 4xx
Internal data saving error
▶ Turn the machine off and at‐
tempt to turn it back on again.
Fibre not plugged in
Code 201
The SMA fibre connection is not
▶ Check the SMA fibre connection
plugged in or screwed in or pluggedplug.
in or screwed in securely.
The fiber plug must be inserted
all the way in to the device-side
SMA socket, and the union nut
must be tightened clockwise.
Door Interlock
Code 200
Door contacts are separated.
49/55
▶ Properly connect the door con‐
tacts.
8 Troubleshooting | 8.2 Malfunctions without error messages
Malfunction
Cause
Remedy
The door contact plug is not plugged ▶ or
in.
Activate the door contact switch.
The door is open
▶ Close the door.
Power supply
Code xxx
Power supply malfunction
Foot switch
Code xxx
The foot switch is already pressed ▶ Pull your foot off of the foot
when switching to the Ready mode
switch and switch to Ready
The foot switch is defective
mode.
▶ Turn the machine off and at‐
tempt to turn it back on again.
8.2 Malfunctions without error messages
Malfunction
Cause
The device suddenly turns off with‐ Unknown safety-relevant error
out an error message.
An error message not described in
these instructions for use occurs.
Remedy
▶ Pull the power plug to separate
the machine from the mains.
▶ Contact customer service.
The device does not react after turn‐ No power
ing the key holder.
▶ Check if the power cable can be
inserted in a socket.
▶ Check if the main switch is at |.
▶ Check if the laser emergency off
button is deactivated.
▶ If the problem continues, pull the
power plug and check the mains
fuses.
Pull out the fuse unit.
▶ If the problem continues, check
the line fuse of the building.
The pilot beam does not appear at Problems with the pilot beam emis‐ ▶ Exchange the fibre applicator.
the fibre outlet in the handpiece.
sion
or
Damaged fibre cable
Turn the machine off and on.
Problems with the control electron‐ ▶ If the problem continues, contact
ics
customer service.
The device does not work properly
The function keys of the display do Touchscreen miscalibrated
not react or are sporadic.
▶ Contact customer service.
No laser pulse when the footswitch The unit is instandby mode.
is pressed.
The connecting cable for the foot‐
switch is not properly connected.
▶ Press the "Ready" key.
▶ Connect the connecting cable.
50/55
9 Information on electromagnetic compatibility | 9.1 Emitted electromagnetic interference
9 Information on electromagnetic compatibility
Note
KaVo cannot guarantee the compliance of accessories, enclosed cables, and other
components not supplied by KaVo with EMC requirements of EN 60601-1-2.
Accessory part/name
Footswitch with cable
Non-heating apparatus
connecting line
Article number
Mat. no. 1.005.2885
Mat. no. 0.223.4142
Length/dimensions
< 3.0 m
< 3.0 m
Note
The GENTLEray 980 is exclusively intended for use by medical professionals. In
residential areas, the GENTLEray 980 may cause radio interference in certain cir‐
cumstances so that it may be necessary to undertake suitable measures such as
realigning, rearranging or screening the GENTLEray 980, or filtering the connection
with the public power supply.
9.1 Emitted electromagnetic interference
The GENTLEray 980 is suitable for use in an electromagnetic environment like the
one cited below. The customer and/or operator of the GENTLEray 980 should make
sure that the machine is used in an electromagnetic environment as described be‐
low.
Measuring emitted interference
Conformance
High-frequency interference
according to CISPR 11
Group 1
High-frequency interference
according to CISPR 11
Class B
Transmission of harmonics
according to IEC 61000-3-2
Class A
Transmission of voltage fluctua‐
tions/flicker
according to IEC 61000-3-3
Conforms
Guidelines for the electromagnetic
environment
The GENTLEray 980 uses HF en‐
ergy only for its internal operation.
Its HF transmission is therefore very
low, and it is improbable that neigh‐
bouring electronic devices will be
disturbed.
The GENTLEray 980 has been de‐
signed for use in all facilities includ‐
ing residential and facilities that are
directly connected to a public power
supply that also supplies residential
buildings.
buildings.
buildings.
51/55
9 Information on electromagnetic compatibility | 9.2 Electromagnetic Immunity
9.2 Electromagnetic Immunity
low.
Testing for electromag‐ Test level
Conformance level
netic immunity
according to
DIN EN 60601-1-2
Discharge of static
± 6 kV contact dis‐
± 6 kV
electricity (ESD)
charge
± 8 kV
according to
± 8 kV atmospheric dis‐
DIN EN 61000-4-2
charge
Fast transient electric
interference/bursts
according to
DIN EN 61000-4-4
Surges
according to
DIN EN 61000-4-5
Voltage interruptions,
short-term interruptions
and fluctuations of the
supply voltage accord‐
ing to DIN EN
61000-4-11
Magnetic field with the
given supply frequency
(50/60 Hz)
according to
DIN EN 61000-4-8
± 2 kV for power lines ± 2 kV
± 1 kV for input and out‐ *
put lines
± 1 kV
Push-pull voltage
± 2 kV
Common mode voltage
<5%
Ut for y periods
(>95% interruption)
40% UT
Ut for 5 periods
(60% interruption)
70 %t
Ut for 25 periods
(30 % interruption)
<5%
Ut for 5 seconds
(>95% interruption)
3 A/m
± 1 kV
± 2 kV
<5%
40 %
70 %
<5%
3 A/m
environment
Floors should be made of wood or
concrete or have ceramic tiles.
When the floor is covered with syn‐
thetic material, the relative humidity
must be at least 30%.
The quality of the supply voltage
should correspond to that of a typi‐
cal business or hospital
environment .
environment .
environment . If the user of the ma‐
chine requires continuous
Operation even when there are in‐
terruptions to the power supply, it is
recommendable to supply the ma‐
chine from an uninterrupted power
supply or a battery .
Magnetic fields at the mains fre‐
quency should correspond to typi‐
cal values in a business and
hospital environment .
Note: Vt is the alternating mains voltage before the test level is used.
*not tested since the line length is less than 3 m
9.3 Electromagnetic Immunity
low.
52/55
9 Information on electromagnetic compatibility | 9.4 Recommended safe distance
Testing the noise im‐
munity
Conducted HF distur‐
bances
according to
DIN EN 61000-4-6
Radiated HF disturban‐
ces
according to
DIN EN 61000-4-3
Test level according to
DIN EN 60601-1-2
3 Veff
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Conformance level
3V
3 V/m
environment
Portable and mobile radio devices
should not be used closer to the
GENTLEray 980 including the
wires, than the recommenced safe
distance calculated using the equa‐
tion for the transmission frequency.
Recommended safe distance:
d = [3.5/3V] P
d= [3.5/3] P m
for 80 MHz to 800 MHz
d= [7/3] P m
for 800 MHz to 2.5 GHz
with P as the rated power of the
transmitter in Watts (W) according
to the transmitter manufacturer,
and d as the recommended safe
distance in meters (m).
The field strength of stationary ra‐
dio transmitters should be less than
the conformance level at all fre‐
quencies in an on-site checka.b
Disturbances are possible close to
devices that have the following
symbol.
The field strength of stationary transmitters such as base stations of mobile tele‐
phones (cellular/cordless), mobile land radio devices, amateur radio stations, AM
and FM radio and television broadcasters cannot be theoretically predetermined.
To determine the electromagnetic environment of stationary transmitters, a study of
the location should be considered. When the measured field strength at the location
where the machine is used exceeds the above conformity level, the machine should
be watched to ensure that it is functioning properly. If it is observed that the machine
is unsuitable for use, additional measures may be required, such as a different
alignment or another location for the machine.
b
Within the frequency range of 150 kHz to 80 MHz, the field strength should be less
than 3V/m.
a
Note: These guidelines may not be applicable in every case. The spread of elec‐
tromagnetic waves is absorbed and reflected by buildings, objects and people.
9.4 Recommended safe distance
Recommended safe distances between portable and mobile high-frequency tele‐
communications devices and the GENTLEray 980 according to DIN EN 60 601-1-2
Transmission frequency
Equation
Rated power of the trans‐
mitter (Watts)
0,01
0,1
1
150 kHz to 80 MHz
d = [3.5/3] P
Safe distance
(meters)
0,12
0,37
1,17
150 kHz to 80 MHz
d = [3.5/3] P
Safe distance
(meters)
0,12
0,37
1,17
53/55
800 MHz to 2.5 GHz
d = [7/3] P
Safe distance
(meters)
0,23
0,74
2,33
9 Information on electromagnetic compatibility | 9.4 Recommended safe distance
Transmission frequency
Equation
Rated power of the trans‐
mitter (Watts)
10
100
150 kHz to 80 MHz
d = [3.5/3] P
Safe distance
(meters)
3,70
11,70
150 kHz to 80 MHz
d = [3.5/3] P
Safe distance
(meters)
3,70
11,70
800 MHz to 2.5 GHz
d = [7/3] P
Safe distance
(meters)
7,37
23,30
For transmitters whose maximum rated power is not in the above table, the safe
distance can be calculated using the equation for the respective gap, where P is the
maximum rated power of the transmitter in Watts (W) according to the information
of the manufacturer of the transmitter.
Note: These guidelines may not be applicable in every case. The spread of elec‐
tromagnetic waves is absorbed and reflected by structures, objects and people.
54/55
10 Replacement parts and accessories
10 Replacement parts and accessories
Note
KaVo notes that Medical Device Act only permits the use of accessories that have
been released for this laser and that are provided by KaVo for this laser. You can
obtain a current accessories list from KaVo at any time.
CAUTION
Damage from use of improper accessories. Damage can occur when accessory
parts by other manufacturers are used.
Only use original accessory parts.
Accessories for the GENTLEray 980 Premium
Description
Bare Fiber 200 μm, 3 m
Bare Fiber 300 μm, 3 m
982 Bleaching Handstück und Fiber
Bleaching-Fiber
Mat. No.
Mat. no. 1.006.5431
Mat. no. 1.006.4428
Mat. no. 1.005.2895
Mat. no. 1.005.2896
Replacement parts for the GENTLEray Premium
Description
Straight cannula (3)
Cannula, curved 30° (3)
Cannula, curved 70° (3)
Laser safety goggles, Value Line
Laser safety goggles XC (with insert for
people who wear glasses)
Laser warning sign
Handpiece 981, Classic (incl. 2x3 can‐
nulas)
GENTLEray 981 Austauschkit
55/55
Mat. No.
Mat. no. 1.005.2887
Mat. no. 1.005.2888
Mat. no. 1.005.2889
Mat. no. 1.005.2894
Mat. no. 1.005.3955
Mat. no. 0.236.2439
Mat. no. 1.004.9800
Mat. no. 1.007.3072
1.005.4073 · kb · 20101025 - 13 · en

Instructions for use GENTLEray 980 | US

Transcription

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