KaVo ARCUSevo User manual

Instructions for use
ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000

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

Contents
1 User instructions ................................................................................................................ 5
1.1 User guide .................................................................................................................... 5
1.1.1 Abbreviations..................................................................................................... 5
1.1.2 Symbols............................................................................................................ 5
1.1.3 Target group ..................................................................................................... 5
1.2 Service......................................................................................................................... 5
1.3 Warranty provisions....................................................................................................... 6
1.4 Transportation and storage............................................................................................. 6
1.4.1 Currently valid packaging regulations ................................................................... 6
1.4.2 Damage in transit .............................................................................................. 6
1.4.3 Information on the packaging: Storage and transportation ..................................... 7
2 Safety.................................................................................................................................. 9
2.1 Description of safety instructions..................................................................................... 9
2.1.1 Description of hazard levels................................................................................. 9
2.1.2 Warning symbol................................................................................................. 9
2.1.3 Structure........................................................................................................... 9
2.2 Intended use................................................................................................................. 9
2.2.1 General information............................................................................................ 9
2.2.2 Product-specific.................................................................................................. 11
2.2.3 Disposal ............................................................................................................ 11
2.3 Safety Instructions ........................................................................................................ 11
3 Product description ............................................................................................................ 13
3.1 Scope of delivery........................................................................................................... 13
3.2 ARCUSevo .................................................................................................................... 14
3.3 ARCUS ......................................................................................................................... 15
3.4 Technical data............................................................................................................... 15
4 Operation............................................................................................................................ 17
4.1 ARCUSevo .................................................................................................................... 17
4.1.1 Adapting the facial bow....................................................................................... 17
4.1.2 Mount the facial bow .......................................................................................... 17
4.1.3 Removing the facial bow ..................................................................................... 19
4.2 ARCUS ......................................................................................................................... 20
4.2.1 Adapting the facial bow....................................................................................... 20
4.2.2 Placing the facial bow ......................................................................................... 20
4.2.3 Removing the facial bow ..................................................................................... 22
5 Reprocessing steps in accordance with DIN EN ISO 17664...............................................23
5.1 Cleaning ....................................................................................................................... 23
5.1.1 Preparations at the site of use ............................................................................. 23
5.1.2 Machine cleaning................................................................................................ 23
5.1.3 Manual cleaning ................................................................................................. 23
5.2 Disinfection................................................................................................................... 23
5.2.1 Manual disinfection............................................................................................. 23
5.2.2 Automated disinfection ....................................................................................... 24
5.3 Packaging ..................................................................................................................... 24
5.4 Sterilisation................................................................................................................... 24
Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
Contents
3 / 30

5.5 Storage ........................................................................................................................ 24
6 Accessories ......................................................................................................................... 25
7 Spare parts sheet ...............................................................................................................26
Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
Contents
4 / 30

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
1 User instructions | 1.1 User guide
1 User instructions
1.1 User guide
Requirement
Read these instructions prior to first startup to avoid misuse and prevent dam-
age.
1.1.1 Abbreviations
Ab-
brevi-
ation
Explanation
IfU Instructions for use
CI Care instructions
AI Assembly instructions
TI Technician's instructions
SC Safety checks
IEC International Electrotechnical Commission
RI Repair instructions
EMC Electromagnetic compatibility
PI Processing instructions
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:
[phone]
[e-mail] or [e-mail]
Please indicate the product serial number in all requests!
For further information, please visit: www.kavo.com
5 / 30

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
1 User instructions | 1.3 Warranty provisions
6 / 30
1.3 Warranty provisions
The following warranty conditions apply to this KaVo medical device:
KaVo provides the end customer with a warranty of proper function and guar-
antees zero defects in respect of material and processing for a period of 12
months from the date of the invoice, subject to the following conditions:
In case of justified claims, KaVo will honour its warranty with a free replace-
ment or repair. Other claims of any kind whatsoever, in particular with respect
to compensation, are excluded. In the event of default, gross negligence or in-
tent, this shall only apply in the absence of mandatory legal regulations to the
contrary.
KaVo shall not be liable for defects and consequences thereof that have or may
have arisen from natural wear, improper handling, improper cleaning, servicing
or care, non-compliance with operating or connection instructions, calcination
or corrosion, contaminated air or water supplies as well as chemical or electrical
influences that are deemed abnormal or non-permissible in accordance with
KaVo's instructions for use or other manufacturer's instructions. The warranty
granted does not usually extend to lamps, optical fibres made of glass and
glass fibres, glassware, rubber parts, and the colourfastness of plastic parts.
All liability is excluded if defects or consequences thereof originate from manip-
ulations of or changes to the product made by the customer or a third party
without authorisation by KaVo.
Service warranty claims will only be accepted if the product is submitted along
with proof of purchase in the form of a copy of the invoice/delivery note. The
dealer, purchase date, type, and serial number must be clearly evident from
this document.
1.4 Transportation and storage
1.4.1 Currently valid packaging regulations
Note
Only valid for the Federal Republic of Germany.
Dispose of and recycle the sales packaging appropriately in accordance with
current packaging regulations, employing waste management or recycling com-
panies. Comply with the comprehensive return system. KaVo has had its sales
packaging licensed for this purpose. Please comply with 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.

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
1 User instructions | 1.4 Transportation and storage
4. Report the damage to the shipping company.
5. Report the damage to KaVo.
6. Consult with KaVo first, before returning a damaged product.
7. Send the signed delivery receipt to KaVo.
If the product is damaged but there was no discernable damage to the pack-
aging on 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 any of the above-men-
tioned obligations will mean that the damage will be considered to have
arisen following delivery (in accordance with the General German Freight For-
warders' Terms and Conditions, Art. 28).
Outside Germany
Note
KaVo shall not be held liable for damage arising from transportation.
The shipment must be checked on arrival.
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 pack-
aging on delivery, proceed as follows:
1. Report any damage to the shipping company immediately and no later than
7 days after delivery.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use a damaged product.
Note
If the recipient fails to comply with any of the above-mentioned obligations,
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 servi-
cing or repair.
7 / 30

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
1 User instructions | 1.4 Transportation and storage
8 / 30
The symbols printed on the outside are for transportation and storage, and
have the following meaning:
Transport upright with the arrows pointing upwards!
Fragile - protect against impact!
Protect from moisture!
Permissible stacking load
Temperature range
Humidity
Air pressure
SN Serial number
REF Material number
Type Device type
CE mark according to Medical Devices Directive EC 93/42
HIBC Code
Manufacturer
GOST R certification
GOST R certification
Date of manufacture - Year - Month - Day
EAC conformity mark (Eurasian Conformity)
Read and take note of the content of accompanying documents
Follow the instructions for use

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
2 Safety | 2.1 Description of safety instructions
2 Safety
2.1 Description of safety instructions
2.1.1 Description of hazard levels
The warning and safety notes in this document must be observed to prevent
personal injury and material damage. The warning notes are designated as
shown below:
NOTICE
In cases which – if not prevented – could lead to material damage.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property or mild to
moderate injuries.
WARNING
WARNING
indicates a hazardous situation that can lead to serious or fatal injury.
DANGER
DANGER
indicates a maximal hazard due to a situation that can directly cause death or
fatal injury.
2.1.2 Warning symbol
Warning symbol
2.1.3 Structure
DANGER
The introduction describes the type and source of the hazard.
This section describes potential consequences of non-compliance.
▶The optional step includes necessary measures for hazard prevention.
2.2 Intended use
2.2.1 General information
The functional safety and proper condition of the device must be checked be-
fore each use of the device.
This KaVo product is intended for use in dentistry only. Any other type of use is
not permitted.
9 / 30

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
2 Safety | 2.2 Intended use
10 / 30
"Proper use" includes compliance with all instructions for use and the inspection
and maintenance intervals.
The overarching guidelines and/or national laws, national regulations and the
rules of technology applicable to medical devices for startup and use of the
KaVo product for the intended indications for use must be applied and followed.
KaVo accepts liability for the safety, reliability, and performance of components
supplied by KaVo, provided:
▪ installation, instructions, expansions, adjustments, changes or repairs were
carried out by technicians trained by KaVo or third parties authorised by
KaVo, or by the personnel of authorised distributors.
▪ the unit was operated in accordance with the instructions for use, servicing
and assembly.
It is a responsibility of the user:
▪ to only use equipment that is operating correctly,
▪ to protect him or herself, the patient and third parties from hazards, and
▪ to prevent contamination from the product
The applicable national legal regulations must be observed during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and startup of medical
devices.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
The following persons are authorised to conduct repairs and servicing and the
safety check on the KaVo product:
▪ Technicians of KaVo branch offices after appropriate product training.
▪ Specifically KaVo-trained technicians of KaVo franchised dealers.
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, MP-
BetreibV).
Note
The product must be reprocessed and serviced according to instructions be-
fore and after extended period of time in which it is not used. Only use hy-
gienic perfect products on the patient!
Note
Only accessories licensed for use with this machine may be used.
Note
All components contacting the patient's mucous membranes must be steril-
ised before the initial start-up.

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
2 Safety | 2.3 Safety Instructions
2.2.2 Product-specific
The ARCUSevo / ARCUS facial bow records the position of the patient's maxilla.
When creating a prosthesis, a working or tooth model can be correctly posi-
tioned in an articulator.
The facial bow is suitable for recording the Frankfurter horizontal and Camper's
plane.
2.2.3 Disposal
Note
Any waste which is generated must be recycled or disposed of in strict com-
pliance with all applicable national regulations in a manner which is safe both
for people and the environment.
If you have any questions regarding proper disposal of the KaVo product,
please contact the KaVo branch.
2.3 Safety Instructions
Note
All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.
NOTICE
Premature wear and malfunctions from improper servicing and care.
Reduced product life.
▶The product does not need any special servicing to maintain its mechanical
properties. Do not use oils or greases.
WARNING
Injury or damage from damaged functional parts.
If functional parts are damaged, it can cause additional damage or personal in-
jury.
▶If functional parts are damaged: discontinue your work and have the dam-
age repaired.
▶Perform a visual inspection and a functional check before you use the
device.
CAUTION
The reference pointer may touch the patient.
Eye injury, knock/startling
▶When you place the facial bow, position the reference pointer in resting po-
sition away from the face. Move the reference pointer slowly and carefully
towards the patient while avoiding any contact with the skin.
11 / 30

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
2 Safety | 2.3 Safety Instructions
12 / 30
CAUTION
Bruising at the ear
Injuries
▶Before you place the facial bow, set a sufficient distance considering the
head size of the patient. Carefully place the earbuds in the auditory canals
and fix them without injuring the patient. After completion of the measure-
ment, return the earbuds to their starting position.

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
3 Product description | 3.1 Scope of delivery
3 Product description
3.1 Scope of delivery
Figure Name
Facial bow ARCUSevo / ARCUS incl.
Earbuds
Nose support
Reference pointer
Bite fork support
Bite fork
Instructions for use
13 / 30

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
3 Product description | 3.2 ARCUSevo
14 / 30
3.2 ARCUSevo
①Bow ②Fastening nut for the earbud
③Earbud ④Nose support
⑤Lock lever for the nose support ⑥Reference pointer for the Frank-
furter horizontal and Camper's
plane
⑦Fastening nut of the bite fork sup-
port
⑧Adjustment wheel for adjusting the
facial width
⑨Bite fork support ⑩Knurled screw of the bite fork sup-
port
⑪Bite fork

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
3 Product description | 3.3 ARCUS
3.3 ARCUS
①Arch ②Earbuds
③Fastening nuts for earbuds ④Nose support
⑤Lock lever for the nose support ⑥Reference pointer for FH + CP
⑦Clamping lever for adjustment of
the facial width
⑧Fastening nut of the bite fork sup-
port on the ARCUS
⑨Bite fork support ⑩Toggle screw of the bite fork sup-
port
⑪Bite fork
3.4 Technical data
Dimensions and weights of the ARCUSevo
Facial width 100 mm to 185 mm
Weight 250 g
Weight of bite fork/bite fork support 100 g
Dimensions and weights of the ARCUS
Facial width 106 mm to 186 mm
Weight 200 g
Weight of bite fork/bite fork support 100 g
Ambient conditions
Permissible operating temperature 10 °C to 40 °C
Relative Humidity 5% to 95% (non-condensing)
Storage temperature -20 °C to 55 °C
15 / 30

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
3 Product description | 3.4 Technical data
16 / 30
Information on the planes and reference points
Frankfurter horizontal ② (FH):
Connection between the infraorbital point ① and porion ③
Camper's plane ⑤ (CP):
Connection between the subnasal point ④ and Targus medialis ⑥
The angle difference between the FH and CP is 15o.

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
4 Operation | 4.1 ARCUSevo
4 Operation
4.1 ARCUSevo
4.1.1 Adapting the facial bow
ARCUSevo
▶Turn the adjustment wheel ③.
ðThe earbuds ② move further apart. The bow ① can be placed on the pa-
tient.
4.1.2 Mount the facial bow
The facial bow is mounted with reference to the Frankfurter horizontal and the
Camper's plane.
CAUTION
Non-approved registration materials
Hazard for the patient
▶Use approved registration materials only!
CAUTION
The reference pointer may touch the patient.
Eye injury, knock/startling
▶When you place the facial bow, position the reference pointer in resting po-
sition away from the face. Move the reference pointer slowly and carefully
towards the patient while avoiding any contact with the skin.
▶Place the prepared bite fork in the patient's mouth. The fastening pin must
be situated on the side of the right upper jaw.
17 / 30

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
4 Operation | 4.1 ARCUSevo
18 / 30
▶Adapt the bow ⑥ to the width of the patient's face.
▶Insert the earbuds ⑦ into the outer auditory channel of the patient.
▶Align the facial bow with the desired reference point (infraorbital point for
the Frankfurter horizontal or the subnasal point for the Camper's plane).
▶Affix the nose support ① with the the lock lever ②.
Note
If the Frankfurter horizontal is used, the reference pointer must be inserted
with the pointer guide at position ④ as in the picture.
If the Camper plane is used, the reference pointer must be moved with the
pointer guide below the adjustment wheel at position ⑤.
▶Remove the knurled screw ②.
▶Shove the bite fork support ③ onto the bite fork ④.
▶Suspend the bite fork support ③ on the facial bow and tighten it with the
fastening nut ①. Make sure that the guide pins of the bite fork support ③
engage in the guide groove of the facial bow.
See also: following picture.
▶Tighten the knurled screw ② to affix the bite fork ④.

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
4 Operation | 4.1 ARCUSevo
①Guide pins of the bite fork support ②Guide groove of the facial bow
4.1.3 Removing the facial bow
▶Open the lock lever ④ of the nose support ③, push back the nose support
③ and fix.
▶Turn the setting wheel ⑤ to remove the earbuds ② of the facial bow ①
from the ears.
▶Completely remove the facial bow from the patient with bite fork ⑥ fixed in
the correct position.
For information on the transfer into the articulator, see the instructions for use
of the KaVo PROTAR Articulator.
19 / 30

Instructions for use ARCUSevo - 1.005.0900 / ARCUS - 0.622.5000
4 Operation | 4.2 ARCUS
20 / 30
4.2 ARCUS
4.2.1 Adapting the facial bow
ARCUS
▶Open the clamping lever ⑦ and open up the bow ①.
ðThe bow ① can be placed on the patient.
4.2.2 Placing the facial bow
The facial bow is mounted with reference to the Frankfurter horizontal and the
Camper's plane.
CAUTION
Non-approved registration materials
Hazard for the patient
▶Use approved registration materials only!
CAUTION
The reference pointer may touch the patient.
Eye injury, knock/startling
▶When you place the facial bow, position the reference pointer in resting po-
sition away from the face. Move the reference pointer slowly and carefully
towards the patient while avoiding any contact with the skin.
▶Place the prepared bite fork ⑪ in the patient's mouth.