Sirona C5+ Turn, C5+ Installation Requirements

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General information Sirona Dental Systems GmbH
Installation Requirements
60 27 978 D3415
2 D3415.021.03.08.02
Changes since the last version 06.2013:
Chapter or section, page
1.2 Connection to the public drinking water supply ....... 7
1.3 Media quality ........................................................... 8
2.4 Standards/Approvals ............................................. 30
About this document
This document describes the installation requirements for the C5
+
, C5+Turn dental treatment centers.
The following sets of Installation Instructions describe the subsequent installation procedure:
REF 59 57 472 (C5+)
REF 59 74 675 (C5+Tur n )
You will also need the following drilling template in order to fasten the treatment center securely to the floor:
REF 58 71 673
General information
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Sirona Dental Systems GmbH List of Contents Installation Requirements C5
+
, C5+Tu r n
60 27 978 D3415 D3415.021.03.08.02
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1 Preparations.......................................................................................................................... 5
1.1 Safety........................................................................................................... 6
1.2 Connection to the public drinking water supply ........................................... 7
1.3 Media quality................................................................................................ 8
1.4 Supply lines in the termination panel........................................................... 9
1.5 Underfloor installation of SIVISION connections ......................................... 12
1.6 Mounting plates for equipment with fixed cuspidor (not for C5
+
Turn) ....................................................................................... 13
1.7 Mounting plates for equipment with swiveling cuspidor (not for C5
+
Turn) ....................................................................................... 14
1.8 M1 adapter plate for equipment with swiveling cuspidor (not for C5
+
Turn) ....................................................................................... 15
1.9 Demonstration chair plate C5
+
Turn ............................................................. 16
2 Dimensions, technical data ................................................................................................. 17
2.1 Dimensions of the C5+ 1:20 ......................................................................... 18
2.2 Dimensions of the C5+ Turn 1:20................................................................. 21
2.3 Technical data ............................................................................................. 28
2.4 Standards/Approvals ................................................................................... 30
3 Electromagnetic compatibility ............................................................................................ 33
3.1 Accessories ................................................................................................. 34
3.2 Electromagnetic emission............................................................................ 35
3.3 Immunity to interference .............................................................................. 36
3.4 Working clearances ..................................................................................... 38
3.5 Foot control wireless interface..................................................................... 39
List of Contents
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List of Contents Sirona Dental Systems GmbH
Installation Requirements C5
+
, C5+Tu r n
60 27 978 D3415
4 D3415.021.03.08.02
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C5+, C5+Tur n
60 27 978 D3415 D3415.021.03.08.02
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1 Preparations
1.1 Safety .................................................................................................................................... 6
1.2 Connection to the public drinking water supply ..................................................................... 7
1.3 Media quality ......................................................................................................................... 8
1.4 Supply lines in the termination panel ..................................................................................... 9
1.5 Underfloor installation of SIVISION connections ................................................................... 12
1.6 Mounting plates for equipment with fixed cuspidor (not for C5
+
Turn) .................................. 13
1.7 Mounting plates for equipment with swiveling cuspidor (not for C5
+
Turn) ........................... 14
1.8 M1 adapter plate for equipment with swiveling cuspidor (not for C5
+
Turn) .......................... 15
1.9 Demonstration chair plate C5
+
Turn ....................................................................................... 16
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+
, C5+Tu r n
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Identification of the danger levels
To prevent personal injury and material damage, please observe the warning and safety information provided in the present Operating Instructions. Such information is high­lighted as follows:
DANGER
An imminent danger that could result in serious bodily injury or death.
WARNING
A possibly dangerous situation that could result in serious bodily injury or death.
CAUTION
A possibly dangerous situation that could result in slight bodily injury.
NOTICE
A possibly harmful situation which could lead to damage of the product or an object in its environment.
IMPORTANT
Application instructions and other important information.
Tip: Information on making work easier.
General safety information
WARNING
The installation must be carried out in accordance with the requirements stated in our Installationsvoraussetzungen.
WARNING
Installation may be carried out only by personnel specifical­ly authorized by Sirona.
WARNING
For reasons of product safety, this product may be operated only with original Sirona accessories or third-party accessories expressly approved by Sirona. The user is responsible for any damage re-
sulting from the use of non-approved accessories. If any equipment not approved by Sirona is con­nected, it must comply with the applicable stan­dards, e.g.:
• IEC 60950-1 for information technology equip­ment and
• IEC 60601-1 for medical electrical equipment. In case of doubt, contact the manufacturer of the system components.
WARNING
Any person who assembles or modifies a medical electrical system complying with the standard IEC 60 601-1 Chapter 16 by combining it with other equipment (e.g. by connecting a PC) is responsible for ensuring that the requirements of this regula­tion are met to their full extent for the safety of the patients, the operators and the environment.
NOTICE
The floor must be flat and level (DIN 18 202). A mounting plate must be used for uneven floors (see Section 1.6, "Mounting plates for equipment with fixed cuspidor (not for C5+ Turn)" on page 13).
CAUTION
The floor must have a minimum loading capacity of 0.5N/ cm².
CAUTION
Interference of electromedical devices caused by radio tele­phones: To ensure the operational readiness of electromedical de­vices, the use of mobile radio telephones in the practice or hospital area is prohibited.
CAUTION
Electromagnetic compatibility: The unit should not be op-
erated in the immediate vicinity of other devices. If this proves to be unavoidable, the unit should be monitored to ensure that it is operating properly.
1.1 Safety
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,
Treatment center with isolation from public drinking water supply
Provided it is equipped with a disinfection system, the treat­ment center fulfills the requirements of EN 1717 (free outlet with sections 20 mm and the German Gas and Water Association (DVGW). It is intrinsically safe in accordance with worksheet W540 and therefore also fulfills the W270 requirements as well as the requirements for plastics used in the transport of drinking water. It can be connected directly to the public drinking water supply.
The treatment center therefore also bears the symbol for the German Gas and Water Association (DVGW) along with the rating plate.
Treatment center without isolation from public drinking water supply
If compliance with EN 1717 is stipulated nationally, appro­priate equipment must be installed beyond the treatment center to protect the public drinking water system.
This applies to device versions without a disinfection sys­tem.
The treatment center then does not bear the DVGW icon.
Please always adhere to the national requirements with regard to connecting treatment centers to the public drink­ing water supply.
1.2 Connection to the public drinking water supply
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Water quality
Lime deposits and corrosion residues in tap water can lead to the following malfunctions:
Premature clogging of the filters in the unit
Rapid clogging of the fine water paths and jets in the treatment instruments
For these reasons, the following points must be observed:
Permitted water pressure: 2.5 bar (36.25 psi) to 6 bar (87 psi)
Permitted minimum flow volume: 3 l/min
For water hardness (total hardness) of 2.2 mmol/l (= 12 °dH), install water softeners. Set the blend hardness to 1.4 mmol/l (= 8 °dH).
Install a conventional fine filter; fineness: > 80 µm (0.08 mm).
Installation must be performed in compliance with the recommendations of the national installation require­ments (e.g. EN 1717).
The water quality must comply with the national re­quirements for drinking water.
The connection must be made to cold water.
When laying the water pipe to the treatment center, comply with the following instructions to reduce the quantity of micro-organisms in the feed pipe:
– Avoid long stub lines to the treatment center.
– Carry out the installation so that, where possible,
other main consumers (such as the sink) are fed from the same line downstream of the treatment center connection.
– Avoid laying the supply line parallel to hot water
pipes.
Observe EN 1717 concerning protection of the public drinking water supply. For details please refer to chap­ter „Connection to the public drinking water supply” on page 7.
Air quality
The air for driving the turbines, for cooling the drives and for the cooling spray must be free from oil, dry and hygienically faultless.
Suction pipe
Install steam trap K.
With a vacuum of pu >0.18 bar back pressure on the bottom connection, the treatment center must be retrofitted with the "Vacuum limiter" retrofit kit (REF 59 68 826).
1.3 Media quality
N
>80 µm
Air
Suction machine
oil-free
Cold water
Dilution hardness
(drinking water quality)
1 bar = 100 kPa = 14.5 psi
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1.4 Supply lines in the termination panel
5
3
6
6
6
7
Center base plate opening to floor
1
2
4
9
1
3/
8
min.
500mm
20”
7, 6
max.
60mm
2 3/8”
3 4 5
max. 5 mm 3/16”
max. 5 mm 3/16”
3/8”
12
10 x 1mm
10 x 1mm
3/8
x 1/32“
3/8
x 1/32“
1
3
/8“
Foot end
3
6
.
5
m
m
5
0
m
m
3
6
.
5
m
m
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Observe the national regulations for electrical installa­tions (e.g. VDE 0100, VDE 0100, Part 710).
Comply with the national regulations for water supply installations (e.g. EN 1717) and sewage installations (e.g. EN 12056-1).
For the suction pipe, observe the instructions in the Suction Machine Installation Instructions.
For fastening the pipe ends in the installation field, we recommend using an installation template. They can be ordered from Sirona under REF 33 15 830.
If necessary, you can also prepare the template your­self based on the above sketch (not true to scale!).
Supply lines in the termination panel
Table 1: Supply lines
Item Description
1 Water inlet pipe 10x1 mm,
corner valve outlet 3/8"
2 Compressed air inlet pipe 10x1mm, corner
valve outlet 3/8"
3 Suction pipe DN40 HT-PP DIN 19560 (polypro-
pylene, inner diameter 36.5mm!)
4 Water drain DN40 HT-PP DIN 19560 (polypro-
pylene, inner diameter 36.5mm!)
5 Installation pipe, DN40 HT-PP DIN 19560
(polypropylene, 40mm!)
6 Suction machine control cable ( )and call
cables ( ) 3x1.5mm
2
7 Power cable 3x1.5mm2
Fuse: 16A slow-blow Recommended: Type B automatic circuit breaker
8 Not applicable
9 Installation pipe (or corresponding flat duct) for
additional requirement e.g. practice network connecting cable
,
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Supply above the floor, "above-floor installation"
The supply pipe ends, corner valves and cables must be routed as shown above.
The retrofit kit for above-floor installation (REF 33 17 265) is required for installation.
CAUTION
For cleaning, flush the air and water pipes thoroughly (metal chips!).
Supply through the floor, "underfloor installation"
1. The top edges of the corner valves for air and water
must not protrude more than 60mm above the upper surface of the finished floor.
2. The suction and drain pipes must be flush with the up­per surface of the floor (a deviation of +5mm is permis­sible). Internal diameter for both pipes: 36,5 mm.
3. The electrical cables must protrude at least 500mm.
Supply lines in the termination panel
>500mm
<5mm
<60mm
>20“
3/8“
<3/16“
<2 3/8“
Ø 36,5 mm
10x1 mm 3/8” x 1/32”
DN 40
>5
00mm
200mm
250mm
> 20’’
8’’
10’’
Ø 36,6mm
3/8“
20
Ø 36,5 mm
Installation template
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Important information for the installer
Depending on the prevailing local conditions, the existing cable set can be installed in the cable duct of an underfloor installation by an installer prior to the installation of the treatment center. In this case, please observe the following:
Proceed with extreme care when running the cables. Par- ticularly cables L15 and L38 are very sensitive, and must never be kinked or twisted. The cables must not overlap or cross one another.
RS232 (L37) and the XGA cable (L38) are not yet cut to length and terminated on the PC side. It would be impossi­ble to pull the cables through when installing them under floor level if a sub D connector were already connected. These cables should always be pulled.
Free length A of cables at the treatment center end: Length A = 600mm
If S video cable L15 is equipped with both a female and a male connector, make sure that the female connector (socket) points to the connection box of the treatment cen­ter.
1. Bend the wire at the front end of cables L37 and L38 to form a hook.
2. Pull cables L15, L37, L38 and the grounding cable of the treatment center through the cable duct to the loca­tion of the PC.
Save the accessory parts for final installation!
1.5 Underfloor installation of SIVISION connections
2.
A
SIVISION
1.
L15, L37, L38, Protective earth conductor
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1.6 Mounting plates for equipment with fixed cuspidor (not for C5
+
Turn)
Mounting plate
Demonstration chair plate
REF 58 26 511
REF 47 08 074
For especially uneven floor conditions, a steel mounting plate is available to compensate for the irregularities of the floor (REF 58 26 511).
For floors which do not permit permanent connection of the unit (e.g. demo operation at a fair), installation on a steel demonstration chair plate is possible (REF 47 08 074).
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1.7 Mounting plates for equipment with swiveling cuspidor (not for C5
+
Turn)
Mounting plate
Demonstration chair plate
REF 58 71 913
REF 58 66 301
For especially uneven floor conditions, a steel mounting plate is available to com­pensate for the irregularities of the floor (REF 58 71 913).
For floors which do not permit permanent connection of the unit (e.g. demo operation at a fair), installation on a steel demonstration chair plate is possible (REF 58 66 301).
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1.8 M1 adapter plate for equipment with swiveling cuspidor (not for C5
+
Turn)
Adapter plate
If the C5+ is installed as a replacement for an M1 at this position, then an adapter plate, with the aid of which the existing mounting holes can be used, is available under the REF 58 70 493.
REF 58 70 493
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1.9 Demonstration chair plate C5+Turn
Demonstration chair plate
750
1266 0,5+
For floors which do not permit per­manent connection of the unit (e.g. demo operation at a fair), installa­tion on a steel demonstration chair plate is possible (REF 59 46,269).
REF 59 46 269
C5
+
Tur n
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2 Dimensions, technical data
2.1 Dimensions of the C5+ 1:20 ................................................................................................... 18
2.2 Dimensions of the C5
+
Turn 1:20 .......................................................................................... 21
2.3 Technical data ....................................................................................................................... 28
2.4 Standards/Approvals ............................................................................................................. 30
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2.1 Dimensions of the C5+ 1:20
Recommended distances from cabinet or wall.
Hazard warning:
The here mounted lamp, the dentist element / with tray (option) and the assistent element with long support arm have a wider swivelling range than the distances indicated!
Center floor opening
250
9 7/8”
> 1100
43 5/16”
> 1100
43 5/16”
2500
98 7/16”
350
13 3/4”
550
21 5/8”
with Swivellable cuspidor
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Standard upholstery
* max.: backrest and chair in highest position
min.: backrest and chair in lowest position
1212
47 3/4”
max. 1340
52 3/4”
min. 810
31 7/8”
* max. 760 30”
min. 400 15 3/4”
45
1 3/4”
1870
73 3/4”
140
5 1/2”
300
11 3/4”
with Swivellable cuspidor
SIROLUX FANTASTICLEDview
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Installation Requirements C5
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, C5+Tu r n
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180
7”
250
9 7/8”
750
29 1/2”
770
30 3/8”
45
1 3/4”
max.1500
59”
max. 1515
59 5/8"
180°
315°
max. 1200
47 1/4"
Option Tray
ca. 830
32 5/8”
2070 +50**
81 1/2” +
2“ **
max. 1200
47 1/4"
440
17 3/8”
max. 380 +15
15“ +5/8”
430 +15
17“ +5/8”
Option Support arm,
long
Option Support arm,
short
Option Swivellable
cuspidor
** according to chair height
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2.2 Dimensions of the C5+ Turn 1:2 0
250
9 7/8”
1600
63”
1600
63”
2500
98 7/16”
350
13 3/4”
Recommended distances from cabinet or wall.
Hazard warning:
The here mounted lamp, the dentist element / with tray (option) have a wider swivelling range than the distances indicated!
Center floor opening
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, C5+Tu r n
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250
9 7/8”
1050
41 3/8”
1050
41 3/8”
2700
106 1/4”
350
13 3/4”
1600
63”
Minimum clearances for conversion of treatment center from right-handed to left-handed version an vice versa 2700x2650mm
1084
42 3/4”
1600
63”
Cabinet right or left max. 900mm height
Center floor opening
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1050
41 3/8”
1300
51 1/8”
250
9 7/8”
3650
143 3/4”
350
13 3/4”
2034
80”
1250
49 1/4”
Minimum clearances for conversion of treatment center from right-handed to left-handed version an vice versa 3650x2350mm
Storage space max. 900mm height
Center floor opening
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, C5+Tu r n
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250
9 7/8”
1050
41 3/8”
1050
41 3/8”
2700
106 1/4”
350
13 3/4”
1084
42 3/4”
1600
63”
Equal working conditions for right-handers and left-handers: Position for right-handers
1600
63”
17°
Center floor opening
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250
9 7/8”
1050
41 3/8”
1050
41 3/8”
2700
106 1/4”
350
13 3/4”
1600
63”
Equal working conditions for right-handers and left-handers: Position for left-handers
1600
63”
1084
42 3/4”
17°
Center floor opening
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SIROLUX FANTASTICLEDview
Standard upholstery
* max.: backrest and chair in highest position
min.: backrest and chair in lowest position
1266
49 7/8”
max. 1340
52 3/4”
min. 810
31 7/8”
* max. 775 30 1/2”
min. 415 16 3/8”
45
1 3/4”
1870
73 3/4”
300
11 3/4”
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180
7”
250
9 7/8”
750
29 1/2”
770
30 3/8”
max.1500
59”
180°
315°
max. 1200
47 1/4"
Option Tray
ca. 830
32 5/8”
210°
45
1 3/4”
max. 380 +15
15“ +5/8”
2070 +50*
81 1/2” +2“ *
800 +50*
31 1/2” +2”
440
17 3/8”
430 +15
17“ +5/8”
* according to chair height
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2.3 Technical data
Technical data C5
+, C5+
Turn
Power supply line 100 V / 115 V / 230 VAC 50 / 60 Hz
Nominal current 11.5 A at 100 V AC
9,5 A at 115 V AC 4,5 A at 230 V AC
In addition, max. 6 A for external devices
Main unit fuse at 100/115 V AC T 10 A H, 250 V AC , REF 10 77 460
at 230 V AC T 6,3 A H, 250 V AC , REF 10 77 452
Transport and storage conditions Temperature: -40°C – +70°C (-40°F – +158°F)
Relative humidity: 10% – 95% Air pressure: 500hPa – 1060hPa
Operating conditions Ambient temperature: 10°C – 40°C (50°F – 104°F)
Relative humidity: 30% – 85% (no condensation) Air pressure: 700hPa – 1060hPa
Maximum load capacity of the patient chair 135kg, including accessories
Installation site
3000 m above sea level
Pollution degree 2 acc. to IEC 60664-1
Protection class Class I device
Device class in accordance with Directive 93/42/EEC
Class IIa equipment
Degree of protection against electric shock Type B applied parts,
except SIROCAM 3/SIROCAM C: Type BF applied parts
Degree of protection against ingress of water Ordinary equipment (not protected)
The foot switch has an IPX1 degree of protection against liquids (drip-proof).
Operating mode Continuous operation with intermittent loading corresponding to the
dental mode of working.
Permanently connected unit.
Year of manufacture
(on rating plate of chair)
On-site pressure readings (1 bar = 100 kPa = 14.5 psi)
Air min./max. Water min./max.
550 kPa / 750 kPa (5.5 / 7.5 bar) 250 kPa / 600 kPa (2.5 / 6 bar)
Foot control wireless interface (not possible for C5+ Turn)
Model designation: Frequency: Transmitting power: Modulation type: Range:
nanoLOC AVR 2,4 GHz – 2,4835 GHz (ISM band) < 2 mW (short range device) MDMA approx. 10 m
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Dimensions of the packaging C5
+
Dentist element, assistant element water unit Chair Upholstery SIROLUX / LEDview
120cm x 63cm x 110cm 120cm x 63cm x 96cm 157cm x 65cm x 83cm 120cm x 52cm x 40cm 10,5cm x 56cm x 28cm
Weight C5
+
(1kg = 2.2lbs) incl. / without packaging
Dentist element, assistant element water unit Chair Upholstery SIROLUX / LEDview
37kg / 13kg 44kg / 16,5kg 126kg / 96kg 13kg / 10kg 14kg / 10kg
Dimensions of the packaging C5+ Turn
Dentist element, assistant element, water unit Chair Upholstery SIROLUX / LEDview
120cm x 63cm x 176cm 157cm x 65cm x 83cm 120cm x 52cm x 40cm 10,5cm x 56cm x 28cm
Weight C5+ Turn (1kg = 2.2lbs) incl. / without packaging
Dentist element, assistant element, water unit Chair Upholstery SIROLUX / LEDview
103kg / 83kg 126kg / 96kg 13kg / 10kg 14kg / 10kg
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2.4 Standards/Approvals
Standards/Approvals
The C5+, C5+ Turn treatment center complies with the following stan­dards, among others:
IEC 60601-1 (electrical and mechanical safety plus software reli­ability)
IEC 60601-1-2 (electromagnetic compatibility)
IEC 60601-1-6 (serviceability)
ISO 6875 (Patient chair)
ISO 7494-1 (Dental treatment devices)
ISO 7494-2 (dental treatment units, water and air supply)
ISO 9680 (Operating light)
ISO 11143 (amalgam separator), see also below (if amalgam separator option is present)
EN 1717 (connection to the drinking water system),
Original language: German
This product bears the CE marking in accordance with the provisions of the Council Directive 93/42/EEC of June 14, 1993 concerning medical devices.
The treatment center meets the requirements of the Canadian Standard Association (CSA) in accordance with CAN/CSA-C22.2 No. 60601-1.
The amalgam separator achieves a separation efficiency of > 95%. The unit thus fulfills the requirements of ISO 11143. Separating procedure type 1: Centrifugal system
The amalgam separator is approved by the German Institute for Struc­tural Engineering (DIBT) and by the French International Organization for Standardization (AFNOR).
When equipped with a disinfection system, the treatment center com­plies with the technical rules and requirements on safety and hygiene for connection to the public drinking water supply.
The unit is certified according to the requirements of the German Tech­nical and Scientific Association for Gas and Water (DVGW). It is intrin­sically safe in accordance with worksheet W540. The unit thus fulfills the requirements of EN 1717, see also the chapter „Connection to the pub­lic drinking water supply” on page 7.
This unit meets the requirements of BELGAQUA and may therefore be connected to the public drinking water supply in Belgium.
0123
SIRONA
Dental Systems
GmbH 64625 Bensheim Fabrikstrasse 31
Z-64.1-14
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Standards/Approvals
The wireless modules in the wireless foot control and in the treatment center meet the requirements of the R&TTE directive 1999/5/'EC. Standards:
EN 60950-1
EN 301489-1, EN 301489-17, EN 300328
The modules meet the requirements of the Federal Communications Commission (Part 15 of the FCC Rules).
FCC ID: SIFNANOLOCAVR0108
Industrie Canada The modules meet the requirements of Industry Canada (RSS2210).
IC: 7654A-nanoLOCAVR
The current approvals for the foot control are listed on the rating label on the underside of the patient chair.
C5
®
is a registered trademark of Sirona Dental Systems GmbH.
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2 Dimensions, technical data Sirona Dental Systems GmbH
Installation Requirements C5
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C5+, C5+Tur n
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3 Electromagnetic compatibility
3.1 Accessories ........................................................................................................................... 34
3.2 Electromagnetic emission ...................................................................................................... 35
3.3 Immunity to interference ........................................................................................................ 36
3.4 Working clearances ............................................................................................................... 38
3.5 Foot control wireless interface ............................................................................................... 39
IMPORTANT
i
The C5+, C5+Turn fulfills all requirements for electromagnetic compatibility (EMC) compliant with IEC 60601-1-2.
The C5
+
, C5+Turn is referred to as "UNIT" in the following.
Observance of the following information is necessary to ensure safe operation regarding EMC aspects.
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•The UNIT may be operated only with accessories and spare parts approved by Sirona. Unapproved accesso­ries and spare parts may lead to an increased emission of or a reduced immunity to interference.
•The UNIT should not be operated immediately adjacent to other devices. If this proves to be unavoidable, the UNIT should be monitored to check and make sure that it is used properly.
The EMC measurements were performed with the following PC:
3.1 Accessories
Making the PC connection
Designation of interface cables to the PC
Supplier
XGA cable, 10m Sirona
S video cable, 10m Sirona
RS232 cable, 10m Sirona
2nd protective ground wire, 2.5mm
2
, 10m Sirona
PC as peripheral device for checking the interfaces with:
Siemens Fujitsu, Pentium IV, 3.0 GHz
Extension of the PC
Graphics card NVIDIA GeForce 7300 LE
Frame grabber card PicPort Color frame grabber
card (Leutron) REF 46 93 961
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The UNIT is intended for operation in the electromagnetic environment specified below.
The customer or user of the UNIT should make sure that it is used in such an environment.
3.2 Electromagnetic emission
Emission measurement Conformity Electromagnetic environment guidelines
HF emission according to CISPR 11 Group 1 The UNIT uses HF energy only for its internal function. The
HF emission is therefore very low, and it is improbable that nearby electronic devices might be disturbed.
HF emission according to CISPR 11 Class B The UNIT is intended for use in all facilities, including residen-
tial areas and in any facilities connected directly to a public power supply providing electricity to buildings used for resi­dential purposes.
Harmonics according to IEC 61000-3-2
Class A
Voltage fluctuations / Flicker according to IEC 61000-3-3
compliant
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The UNIT is intended for operation in the electromagnetic environment specified below.
The customer or user of the UNIT should make sure that it is used in such an environment.
3.3 Immunity to interference
Immunity interfer­ence tests
IEC 60601-1-2 test level Conformance level Electromagnetic environment
guidelines
Electrostatic dis­charge (ESD) accord­ing to IEC 61000-4-2
± 6kV contact discharge
± 8 kV air discharge
± 6kV contact discharge
± 8kV air discharge
Floors should be made of wood or concrete or covered with ceramic til­ing. If the floor surface consists of synethetic material, the relative humidity must be at least 30%.
Electrical fast tran­sient/burst according to IEC
61000-4-4
± 1kV for input and output lines
± 2kV power cables
± 1kV for input and output lines
± 2kV power cables
The quality of the supply voltage should conform to the typical busi­ness or hospital environment.
Surge voltages according to IEC
61000-4-5
± 1kV push-pull voltage
± 2kV push-pull voltage
± 1kV push-pull voltage
± 2kV push-pull voltage
The quality of the supply voltage should conform to the typical busi­ness or hospital environment.
Voltage dips, short interruptions and vari­ations of the power supply according to IEC
61000-4-11
<5% U
T
for ½ period (>95%
dip of U
T
)
40% U
T
for 5 periods (60%
dip of U
T
)
70% UT for 25 periods (30% dip of U
T
)
<5% U
T
for 5sec. (>95% dip
of U
T
)
<5% UT for ½ period (>95% dip of U
T
)
40% U
T
for 5 periods (60%
dip of U
T
)
70% UT for 25 periods (30% dip of U
T
)
<5% U
T
for 5sec.
(>95% dip of U
T
)
The quality of the supply voltage should correspond to the typical busi­ness or hospital environment.
If the user of the UNIT requires it to continue functioning following inter­ruptions of the power supply, it is rec­ommended to have the UNIT powered by an uninterruptible power supply or a battery.
Magnetic field of power frequencies (50/60 Hz) according to IEC
61000-4-8
3 A/m 3 A/m The power frequency magnetic fields
should correspond to the typical val­ues found in the relevant business and hospital environment.
Remarks: U
T
is the AC supply voltage prior to application of the test level.
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Portable and mobile radio equipment must not be used within the recom­mended working clearance from the UNIT and its cables, which is calcu­lated based on the equation suitable for the relevant transmission fre­quency.
Recommended working clearance:
Conducted HF inter­ference
IEC 61000-4-6
3V
eff
150 kHz to 80 MHz
a
3V
eff
Radiated HF interfer­ence
IEC 61000-4-3
3V/m 80MHz to 800MHz
a
3V/m 800MHz to 2.5GHz
a
3V
eff
3V
eff
where P is the nominal transmitter output in watts (W) specified by the transmitter manufacturer and d is the recommended working clearance in meters (m).
The field strength of stationary radio transmitters is based on a local inves­tigation for all frequenciesb less than the conformance level for all frequen­cies
c
.
Interference is possible in the vicinity of equipment bearing the following graphic symbol.
a. The higher frequency range applies at 80MHz and 800MHz.
b. The field strength of stationary transmitters such as the base stations of radio telephones and land mobile services,
amateur radio stations as well as AM and FM radio and television broadcasting stations cannot be accurately predeter­mined. An investigation of the location is recommended to determine the electromagnetic environment resulting from stationary HF transmitters. If the field strength measured at the UNIT location exceeds the conformance level specified above, the UNIT must be observed with respect to its normal operation at each application site. If unusual performance characteristics are observed, it may be necessary to take additional measures such as reorientation or repositioning of the UNIT.
c. A frequency range of 150 kHz to 80 MHz results in a field strength of less than 3 V/m.
Immunity interfer­ence tests
IEC 60601-1-2 test level Conformance level Electromagnetic environment
guidelines
d 12,[]P=
d 12,[]P=
at 80MHz to 800MHz
d 23,[]P=
at 800MHz to 2.5GHz
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Recommended working clearances between por­table and mobile HF communication devices and the UNIT
The UNIT is intended for operation in an electromagnetic environment, where radiated HF interference is checked. The customer or the user of the
UNIT can help prevent
electromagnetic interference by duly observing the mini­mum distances between portable and/or mobile HF com­munication devices (transmitters) and the
UNIT. These
values may vary according to the output power of the rele­vant communication device as specified above.
For transmitters whose maximum nominal output is not specified in the above table, the recommended working clearance d in meters (m) can be determined using the equation in the corresponding column, where P is the max­imum nominal output of the transmitter in watts (W) speci­fied by the transmitter manufacturer.
Annotation 1
The higher frequency range applies at 80 MHz and 800 MHz.
Annotation 2
These guidelines may not be applicable in all cases. The propagation of electromagnetic waves is influenced by their absorption and reflection by buildings, objects and persons.
3.4 Working clearances
Nominal transmitter output [W]
Working clearance according to transmission frequency [m]
150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5 GHz
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
11,21,22,3
10 3,8 3,8 7,3
100 12 12 23
d 12,[]P=
d 12,[]P=
d 23,[]P=
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Insofar as the treatment center is equipped with a foot control, one wireless module each must be installed in the foot control and in the base of the chair of the treatment center. These modules transmit the foot control signals.
CAUTION
Interference with the wireless transmission
This wireless transmission may cause interference with or be disturbed by other radio services.
Wireless module in the wireless foot control and in the treatment center
Fußschalter-Funkschnittstelle
3.5 Foot control wireless interface
Model designation: nanoLOC AVR
Frequency:
2,4GHz–2,4835GHz (ISM band)
Transmitting power: < 2 mW (short range device)
Modulation type: MDMA
Range: approx. 10 m
Page 40
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