KaVo Globus 1078 S User manual

Instructions for use
Globus 1078 S
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
Table of contents 1
1 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 terms and conditions 3
1.4 Transportation and storage 4
1.4.1 Currently valid packaging ordinance 4
1.4.2 Damage in transit 4
1.4.3 Information on the packaging: Storage and transportation 5
2 Safety 7
2.1 Description of safety instructions 7
2.1.1 Warning symbol 7
2.1.2 Description of danger levels 7
2.1.3 Structure 7
2.2 Purpose – Proper use 7
2.2.1 General information 7
2.2.2 Product-specific 10
2.3 Safety instructions 10
2.3.1 General 10
2.3.2 Product-specific 11
3 Product description 14
3.1 Treatment unit 14
3.2 Unit base 15
3.3 Device body with patient unit 16
3.4 Dentist unit 17
3.5 Assistant unit 18
3.6 Key fields 19
3.7 Footswitch 20
3.8 Technical Specifications 21
3.9 Rating plate and identification plate 23
4 Operation 26
4.1 Turn the unit on and off 26
4.2 Change from a right-handed to left-handed design 27
4.3 Adjusting the patient chair 33
4.3.1 Swing the armrest (extra) 33
4.3.2 Adjusting the backrest 33
4.3.3 Adjust head rest 34
4.3.4 Turning the head cushion 38
4.3.5 Adjust chair position 39
4.3.6 Safety shut-off 43
4.3.7 Special chair functions 46
4.4 Move the dentist's unit 46
4.5 Adjust the height of the assistant unit 47
4.6 Swing the patient unit by hand 47
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4.7 Setting functions 48
4.7.1 Select memory level Dentist 1 or Dentist 2 48
4.7.2 Fill the tumbler and rinse the spittoon 48
4.7.3 Turn the x-ray image viewer on and off 49
4.7.4 Activate bell 49
4.7.5 Turn the treatment light on and off using the cold light button 49
4.7.6 Set the time and use the timer (only with Memospeed) - Set the
time 49
4.7.7 Use the function keys (only with the Memospeed) 50
4.8 Using instruments 51
4.8.1 Save instrument-specific settings 51
4.8.2 Select a memory level with the Memospeed 51
4.8.3 Using the turbine 52
4.8.4 Using the INTRA Lux Motor K 200 and INTRA Lux Motor KL 701
54
4.8.5 Operating the PIEZOlux 56
4.8.6 Using the triple and multifunction handpiece 59
4.8.7 Setting the spray mist suction device and saliva ejector 61
5 Preparation methods DIN EN ISO 17664 62
6 Adaptable accessories and kits 63
6.1 Unit base 63
6.2 Patient chair 63
6.3 Patient unit with device body and assistant unit 63
6.4 Dentist unit 64
7 Troubleshooting 65
8 Do safety checks 67
8.1 Measure protective conductor resistance 67
8.2 Measure equivalent unit leakage current 69
8.3 Measure equivalent patient leakage current 70
9 Data on electromagnetic compatibility according to EN60601-1-2
73
9.1 Electromagnetic Transmissions 73
9.2 Resistance to electromagnetic interference 73
9.3 Recommended safe distance between portable and mobile HF tel‐
ecommunications equipment and the treatment unit 74
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1 User instructions
1.1 User guide
Requirement
Read these instructions prior to first use to prevent misuse and damage.
1.1.1 Abbreviations
Abbre‐
viation
Explanation
GA Instructions for use
PA Care instructions
REC Assembly instructions
TA Technician's instructions
STK Safety checks
IEC International Electrotechnical Commission
RA Repair instructions
EMC Electro magnetic compatibility
1.1.2 Symbols
See the section Safety/Warning Symbols
Important information for users and technicians
CE mark (Communauté Européenne). A product with this mark meets the
requirements of the applicable EU directive.
Action required
1.1.3 Target group
This document is for dentists and office personnel.
1.2 Service
Service hotline:
[phone]
[email protected]
Please indicate the product serial number in all requests.
Additional information can be obtained at: www.kavo.comAdditional information can
be obtained at: www.kavo.com
1.3 Warranty terms and conditions
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 the material or
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processing for a period of 12 months from data of purchase, subject to the following
conditions:
Upon justified complaints of flaws or a short delivery, KaVo will make good its war‐
ranty by replacing the product free of cost or repairing it according to the customer's
wishes. Other claims of any nature whatsoever, in particular with respect to com‐
pensation, 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, rubber parts and the colour‐
fastness 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 ordinance
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.
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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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.
3. Leave the product and packaging in the condition in which you received it.
4. Do not use a damaged product.
Note
Failure on the part of the recipient to comply with one of the above obligations will
mean that the damage will be considered to have arisen following delivery (in ac‐
cordance with ADSp. Art. 28).
Outside of 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.
2. Leave the product and packaging in the condition in which you received it.
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 the damage immediately or at least 7 days after the delivery to the de‐
livery company.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use a damaged product.
Note
Failure on the part of the recipient to comply with one 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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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
2.1.1 Warning symbol
Warning symbol
2.1.2 Description of danger levels
The safety instructions cited herein with the three levels of danger will help avert
property damage and injury.
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.
2.1.3 Structure
DANGER
The introduction describes the type and source of the danger.
This section portrays the possible consequences of non-observance.
▶The optional step covers necessary measures for avoiding hazards.
2.2 Purpose – Proper use
2.2.1 General information
The user must ensure that that the unit works properly and is in a satisfactory con‐
dition before each use.
The KaVo Globus 1078 S is a dental treatment unit in accordance with ISO 7494
that has a dental patient chair in accordance with ISO 6875. This KaVo product is
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for dental purposes only and should only be used by medical professionals. The
product may not be used for a purpose for which it was not intended.
"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.
Responsibility is accepted for the safety, reliability and performance of the compo‐
nents supplied by KaVo provided:
▪ installation, expansions, adjustments, changes or repairs are carried out by
technicians trained by KaVo or third parties authorised by KaVo, or by the per‐
sonnel of authorised distributors.
▪ The device must be operated in accordance with the instructions for use, care
and installation.
▪ The IT components supplied by the operator meet the technical requirements in
these instruction for use for hardware and software, and they are installed and
set up according to the descriptions of these components.
▪ During maintenance, observe all the requirements of VDE 0751-1, "Repeated
tests and test before startup of electronic medical devices and systems - general
guidelines".
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.
The safety checks (SC) must be done at 2-year intervals.
Authorized to repair and service the KaVo product:
▪ Technicians from KaVo branches with appropriate product training
▪ Technicians of authorised dealers specially 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
medical devices operator ordinance (Medizinprodukte-Betreiberverordnung,
MPBetreibV).
Note
The product must be cleaned and serviced according to instructions if it is not to
be used for a long period.
Note
Only those accessories may be used that are approved for the device.
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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 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 med‐
ical electronics.
Note
KaVo cannot guarantee that accessories, lines and transformers not delivered by
KaVo will correspond 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 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:
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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.
International (EU)
For country-specific information on disposal, contact your dental supplier.
2.2.2 Product-specific
Use and target group
The KaVo Globus 1078 S is for treating children and adults in a dental context.
The device may only be used by medical professionals.
For technician jobs that require greater pressure than when working in the oral cavity
such as grinding prostheses, etc., a special technician's machine must be used. The
bearings of these machines are correspondingly stronger.
2.3 Safety instructions
2.3.1 General
The KaVo product is not permitted to be used in areas subject an explosion hazard.
CAUTION
Premature wear and malfunctions from improper servicing and care.
Reduced production time.
▶Perform regular proper care and maintenance.
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CAUTION
Insufficient hygiene.
Transmission of pathogens.
▶To maintain the hygienic system, observe the care and servicing instructions.
WARNING
Injury or damage from damaged functional parts.
When functional parts are damaged, it can cause additional damage or personal
injury.
▶When functional parts are damaged, stop working and eliminate the damage
or contact a service technician.
▶Check the electrode lines and accessories for damage to the insulation.
CAUTION
Risks from electromagnetic fields.
The functions of implanted systems (such as pacemakers) can be influenced by
electromagnetic fields.
▶Ask patients before treatment!
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!
2.3.2 Product-specific
CAUTION
Moving the dentist's unit or assistant's unit.
The patient or treatment personnel may be injured or crushed.
▶Be aware of the patient and practice personnel when moving the dentist's unit
or assistant's unit.
CAUTION
Danger of crushing during automatic chair movement.
The patient or treatment personnel can be clamped.
▶Monitor the patient and treatment personnel when changing the chair position.
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CAUTION
Germ formation.
Infections.
▶Before starting, rinse all the water drain lines without instruments.
▶Before startup and after the device has not been used for a while (weekends,
holidays, vacations, etc.), rinse or purge the air and water lines.
▶Thoroughly disinfect.
▶Actuate the tumbler filler several times.
CAUTION
Third party device connection kit (optional): Hazard of reinfection from standing
water.
Infections.
When a water-using unit is connected to the third-party connection kit, always per‐
form the following tasks on the device:
▶Before starting, rinse all the water drain lines without instruments (if applicable).
▶Before startup and after the device has not been used for a while (weekends,
holidays, vacations, etc.), rinse or purge the air and water lines.
▶Make sure that the water-using unit is resistant to H2O2 since the water is steri‐
lised with OXYGENAL 6 (at a concentration up to 0.02%).
CAUTION
Damage to the instrument hoses from stickers.
Instrument hoses can explode.
▶Do not affix stickers or adhesive tape.
CAUTION
Long stay in the patient chair.
Decubitus formation.
▶Take precautions against the formation of decubitus in long treatments.
WARNING
Injury or infection hazard from laid down instruments.
Given the arrangement of the instruments, injury or infections in the hand and un‐
derarm can arise when reaching for the tray holder or operating device. Increased
risk of infection from diseased patients.
▶Be aware of the arrangement of the instruments when accessing the tray holder
or operating device.
CAUTION
Danger of injury from tipping the treatment unit.
Injury to the patient and user.
▶Do not support yourself on the swinging arm.
▶Do not sit on the head or foot end of the patient chair when it is in a horizontal
position.
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CAUTION
Danger of injury from overload.
The patient chair can collapse.
▶Do not subject the patient chair to a load above its limit (135 kg).
CAUTION
Hair may become caught in the patient's chair when the headrest is moved.
Injuries.
▶When moving the patient chair and headrest, be aware of the patient's hair and
that of the practice personnel.
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3 Product description
3.1 Treatment unit
① Standard headrest ⑤ Armrest (extra)
② SOMATIC headrest ⑥ Chair base
③ 2-joint headrest ⑦ Comfort backrest
④ Seat ⑧ Progress backrest
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3.2 Unit base
① Pivotable swing arm for holding the
patient unit, device body and assis‐
tant unit
④ Main fuse
② Supply unit, customer connection of
power, water, compressed air,
wastewater and suction air
⑤ Main switch
③ Rating plate
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3.3 Device body with patient unit
① Patient unit ④ Device body
The central control is in the device
body.
② Tumbler filler ⑤ Pressurised water bottle (extra)
③ Spittoon bowl ⑥ Footswitch
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3.4 Dentist unit
① Small x-ray viewer ⑥ Alternately use the INTRA LUX Motor
K 200 or INTRA LUX Motor KL 701
② Memospeed, Memodent ⑦ Keys and display field
③ Brake ⑧ Instrumentation like ⑥
④ Triple-function handpiece ⑨ PIEZOlux
⑤ Turbine
The arrangement of the instruments can be changed if desired.
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3.5 Assistant unit
① Three-function handpiece or multi‐
functional handpiece
④ Saliva ejector
② Spray mist suction ⑤ Satelec Mini LED
③ Key and display field
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