2320 Telescope Warmer Instruction Manual Index : 10-04-4.0

Important general instructions for use Ensure that this product is only used as intended and described in the instruction manual, by adequately trained and qualified personnel, and that maintenance and repair is only carried out by authorized specialized technicians. Operate this product only in the combinations and with the accessories and spare parts listed in the instruction manual. Use other combinations, accessories and wearing parts only if they are expressly intended for this use and if the performance and safety requirements are met. Reprocess the products before every application and before returning them for repair as required by the instruction manual in order to protect the patient, user or third parties. Subject to technical changes! Due to the further development of our products, illustrations and technical data may deviate slightly from the data in this manual.

CAUTION - USA only: Federal law restricts this unit to be used or sold, except under the supervision of a medical doctor.

GERMANY RICHARD WOLF GmbH D--75438 Knittlingen Pforzheimerstr. 32 Tel.: (..49)--(0)7043--35--0 Fax:(..49)--(0)7043--35300 MANUFACTURER

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Tel.: 847--913 1113 Fax: 847--913 1488

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW 17 0HB Tel.: 020--8944 7447 Fax: 020--8944 1311

E--mail: [email protected] Internet: www.richard--wolf.com

E--mail: sales&[email protected] Internet: www.richardwolfusa.com

E--mail: [email protected] Internet: www.richardwolf.uk.com

BELGIUM N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 B--9031 Gent --Drongen Tel.: +32 9.280.81.00 Fax: +32 9.282.92.16

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F--51100 Reims Tel.: +33 3.26.87.02.89 Fax: +33 3.26.87.60.33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A--1160 Wien Tel.: +43 1-- 405 51 51 Fax: +43 1-- 405 51 51--45

E--mail: [email protected]

E--mail: [email protected]

E--mail: [email protected] Internet: www.richard--wolf.at

HA--E155

0

Symbol

Designation OFF (disconnection from power supply) ON (connection to power supply) Caution, observe ACCOMPANYING DOCUMENTS!

8033.90

Operate only with tube inserts

Fuse A Registered Trademark of ETL, a Recognized Testing Laboratory, listing compliance as Medical Electrical Equipment to standard UL 60601-1 and CAN/CSA C 22.2 No. 601.1 Identification in conformity with Medical Devices Directive 93/42/EEC only valid if the product and/or packaging is marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally marked with the code number of the notified body (0124)

SAFETY INSTRUCTIONS: A second telescope warmer should be at hand if the device fails. The tube inserts are not delivered in sterile condition. Before every use the tube inserts must be reprocessed as described in chapter 5.

2.1.1 .

3a

Combinations IMPORTANT!

In addition to this instruction manual follow the manuals of the products used in combination with this product.

HA-E 155

2.1.2

General requirements on products/components of a combination The general requirements depend on whether the products/components are inside or outside the patient environment. Patient environment

R = 1.5 m h = 2.5 m Patient environment

Acc. to UL 60601--1: R = 1.83 m (6 feet) ; h = 2.29 m (71/2 feet)

Medically used room Inside the patient environment

MP

MP

µ

µ

MP

NMP

µ

µ

MP

NMP

µ

**

outside the patient environment

Non--medically used room

Requirements / measures Leakage currents to clause 19 IEC/EN 60601--1--1 *

--

--

--

--

--

a) additional protective earth connection (to be clarified with manufacturer), or

MP

b) with additional isolating transformer **

NMP

µ MP

NMP

µ

µ

--

--

MP

MP or NMP

µ

µ

additional isolating transformer according to IEC/ EN 60601--1--1 **

additional separating device according to IEC/ EN 60601--1--1

a) common protective earth connection, or b) additional protective earth connection (to be clarified with manufacturer), or c) additional separating device (to avoid earth/ground loops in the case of a potential difference) Functional connection

µ power supply grid

MP NMP

= medical electrical device according to IEC/ EN 60601-1, UL 60601-1, CSA C22.2 No. 601 = non-medical electrical device in accordance with the relevant product-specific IEC/ EN/ UL/ IEC standards

* If connected via a joint mains/power cord under normal conditions the earth leakage current of the system must not exceed 500 µA (300 µA for systems in acc.with UL 60601-1).

** e.g. Richard Wolf Video Trolley with ”isolating transformer”.

HA-E 155

3b

2.1.3 .

2.2

Specific requirements on the products/components of a combination IMPORTANT! Persons combining products to form a system are responsible for not impairing the system’s compliance with the performance and safety requirements, and that the technical data and the intended use are adequately fulfilled. Electromagnetic interference or other types of interference occurring between this product and other products can cause failures or malfunctions. When selecting the system components ensure that they meet the requirements for the medical environment they are used in, in particular IEC/ EN 60601-1-1. In case of doubt contact the manufacturer(s) of the system components. Do not touch connecting devices for electrical connections between the different components (such as signal input and output connections for video signals, data exchange, control circuits, etc.) and the patient at the same time.

Electromagnetic compatibility (EMC)

NOTE: The device or system in the following called product always relates to the Telescope Warmer 2320 Guidance and manufacturer’s declaration - electromagnetic emissions The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment. Emissions measurement/test

Compliance

Electromagnetic environment -- Guidance

HF emissions to CICPR 11

Group 1

The product uses HF energy for its internal function. The HF emission level is extremely low and it is not likely to cause any interference in nearby electronic equipment.

HF emissions to CISPR 11

Class B

Harmonic emissions to IEC 61000--3--2

Class A

In conformity with IEC 61000--3--3 “Voltage fluctuations / flicker emissions”

The product is suitable for use in all establishments, including domestic establishments and those directly connected to the public low--voltage power supply network that supplies buildings used for domestic purposes.

Guidance and manufacturer’s declaration - electromagnetic immunity The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment. Immunity tests

IEC 60601 test level

Compliance

Electromagnetic environment -- guidance

Electrostatic Discharge (ESD) to IEC 61000--4--2

± 6 KV contact ± 8 KV air

Yes

Floors should wood, concrete or ceramic tile. If the floors are covered with synthetic material, the releative humidity should be at least 30%.

Electrical fast transients, bursts to IEC 61000--4--4

± 2 KV for power supply lines ± 1 KV for input/output lines

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Surge voltage (surges) to IEC 61000--4--5

± 1 KV differential mode ± 2 KV common mode

Yes

Mains/line power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines to IEC 61000--4--11

Voltage dip for 0.5 cycle > 95% UT * Voltage dip for 5 cycles > 60% UT * Voltage dip for 25 cycles > 30% UT * Voltage dip for 5 sec > 95% UT *

Yes

Mains/line power quality should be that of a typical commercial or hospital environment. If the user of the product requires continued operation during power mains/line interruptions it is recommended that the product be powered from an uninterruptible power supply or battery.

Power frequency (50/60 Hz) magnetic field, to IEC 61000--4--8

3 A/m

Yes

Power frequency magnetic fields should be at levels characteristic of a typical location in a commercial or hospital environment.

* NOTE: UT is the line/mains voltage prior to application of the test level.

3c

HA-E 155

Guidance and manufacturer’s declaration - electromagnetic immunity for products that are not life-supporting The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment. Immunity test

Compliance level

IEC 60601 test levels

Electromagnetic environment -- guidance

Portable and mobile RF communications equipment should be used no closer to any part of the product, including cables, than the recommended separation distance calculated from equation applicable to the frequency of the transmitter. Recommended separation distance:

d = 1.2 p P d = 1.2 p P for 80 MHz to 800 MHz d = 2.3 p P for 800 MHz to 2.5 GHz

Conducted HF interference to IEC 61000--4--6

3 Vrms 150kHz to 80 MHz

Radiated HF interference to IEC 61000--4--3

3 V/m 80 MHz to 2.5 GHz

Yes

REMARKS:

P = Nominal power output rating of the transmitter in watts (W) (according to the transmitter manufacturer)

d = recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1, should be less than the compliance level in each frequency range2. Interference may occur in the vicinity of devices with the following symbol:

At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may no apply in all situations, as the propagation of electromagnetic waves is affected by absorption and reflexion from buildings, objects and people.

1 = The field strength of fixed transmitters (e.g. base stations for radio telephones, land mobile radios, amateur radio, radio broadcast and TV broadcast, ...), cannot be predicted theoretically with accuracy. To assess the EMC environment due to fixed transmitters an electromagnetic site survey should be conducted. If the measured field strength in the location in which the product is used exceeds the applicable compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product. 2 = Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.

The recommended separation distances between portable and mobile HF telecommunication devices and devices which are not life-supporting The product is intended for use in an electromagnetic environment with HF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunications equipment and the product. Separation distance as a function of transmitter frequency (m)

Rated nominal output power of the transmitter (Watts)

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

d = 1.2 p P

d = 1.2 p P

d = 2.3 p P

For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can be determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W). REMARKS: At 80 MHz and 800 MHz the higher frequency range applies. These guidelines may no apply in all situations. Electromagnetic propagation is affected by absorption and reflexion from buildings, objects and people.

HA-E155

3d

CAUTION! Danger of faults and malfunctions. To guarantee the safety of the user, the patient and others use only accessories and spare parts specified by the manufacturer of this product. Other accessories or spare parts can cause the emission of increased electromagnetic radiation or reduced immunity against interference.

. IMPORTANT!

Medical devices are subject to special precautions with regard to electromagnetic compatibility (EMC). Make sure you observe the notes on EMC for installation and operation. Medical electrical devices can be influenced by mobile HF communication devices. If it is necessary to stack the devices or place them next to each other and HF interference is observed, make sure you observe the intended use of the devices.

3e

HA-E 155

7

Technical data

7.1

Technical data of device Voltage

Frequency

Current rating A

Fuse

Hz

Power consumption VA

V µ

2320.001

220 - 240

50/60

240

1.0

T 1.25 H

2320.002

100 - 127

50/60

165

1.3

T 1.6 H

Model/type

Electromagnetic compatibility (EMC) to

IEC / EN 60601-1-2

Medical Devices Directive 93/42/EC

Category I

Group in acc. with MedGV

3

Safety class in acc. with EN/IEC 60601-1; (UL 60601-1 / CSA C22.2 No.601.1 - for USA)

I

Degree of protection against the ingression of liquids

IP 20 (not protected)

Duty type

Continuous operation This device is not protected against explosions (Do not operate this device in flammable environments)

Degree of protection if used in the presence of flammable gasses Weight

3.7 kg (8.2 lbs)

Dimensions WxHxD

7.2

A

205 mm x 124 mm x 314 mm

Operating, storage, transport and shipping conditions

Operating conditions

+ 10°C to + 40°C , 30% to 75% rel. humidity atmospheric pressure 700 hPa to 1060 hPa

Storage, transport and shipping conditions

- 20°C to + 60°C , 10% to 90% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

.

7.3

To protect the products from damage during transport and shipment we recommend using the original packaging material.

Spare parts and accessories Items

Model/type

Designation Spare parts

1

64068.004

Fuse T 1.6 H (pack of 10St.)

1

64068.003

Fuse T 1.25 H (pack of 10)

1

2440.03

Power cord (Europe), 3.0 m

1

8033.90

Tube insert

1

15135.036

Screw cap Accessories

1

6.08

Cleaning brush ' further accessories on request

HA-E 155

8

:LFKWLJH DOOJHPHLQH $QZHQGXQJVKLQZHLVH 'DV 3URGXNW QXU EHVWLPPXQJVJHPl‰ XQG XQWHU %HDFKWXQJ GHU *HEUDXFKVDQZHLVXQJ GXUFK HQWVSUHFKHQG DXVJHELOGHWHV XQG TXD OLIL]LHUWHV )DFKSHUVRQDO HLQVHW]HQ :DUWXQJ XQG 5HSDUDWXU QXU GXUFK DXWRULVLHUWH )DFKNUlIWH 'DV 3URGXNW QXU LQ GHQ .RPELQDWLRQHQ XQG PLW GHP =XEHK|U XQG GHQ (UVDW]WHLOHQ EHWUHLEHQ GLH LQ GHU *HEUDXFKVDQZHLVXQJ DQJH JHEHQ VLQG $QGHUH .RPELQDWLRQHQ =XEHK|U XQG 9HUVFKOHL‰WHLOH QXU GDQQ YHUZHQGHQ ZHQQ GLHVH DXVGUFNOLFK IU GLH YRUJHVH KHQH $QZHQGXQJ EHVWLPPW VLQG XQG /HLVWXQJVPHUNPDOH VRZLH 6LFKHUKHLWVDQIRUGHUXQJHQ QLFKW EHHLQWUlFKWLJHQ 'LH 3URGXNWH YRU MHGHU $QZHQGXQJ XQG 5FNVHQGXQJ ]XP 6FKXW] YRQ 3DWLHQW $QZHQGHU XQG 'ULWWHQ HQWVSUHFKHQG GHU *H EUDXFKVDQZHLVXQJ DXIEHUHLWHQ 7HFKQLVFKH bQGHUXQJHQ YRUEHKDOWHQ 'XUFK :HLWHUHQWZLFNOXQJHQ N|QQHQ $EELOGXQJHQ XQG 7HFKQLVFKH 'DWHQ JHULQJIJLJ DEZHLFKHQ

.RPELQDWLRQHQ

9RUDXVVHW]XQJ IU HLQH JHPHLQVDPH $QZHQGXQJ GHU YHUVFKLHGHQHQ 3URGXNWH LVW GLH hEHUHLQVWLPPXQJ LQ GHU =ZHFNEHVWLP PXQJ XQG GHQ UHOHYDQWHQ 7HFKQLVFKHQ 'DWHQ 1XW]OlQJH 'XUFKPHVVHU 6SLW]HQVSDQQXQJ XVZ  'LH *HEUDXFKVDQZHLVXQJHQ GHU LQ .RPELQDWLRQ HLQJHVHW]WHQ 3URGXNWH PVVHQ EHDFKWHW ZHUGHQ %HL +)$QZHQGXQJHQ ]XVlW]OLFK GLH *$6  µ+LQZHLVH ]XU +)$QZHQGXQJµ EHDFKWHQ .HQQ]HLFKQXQJ LQ hEHUHLQVWLPPXQJ PLW GHU 5LFKWOLQLH (:* EHU 0HGL]LQSURGXNWH JLOW QXU ZHQQ GDV 3URGXNW XQGRGHU GLH 9HUSDFNXQJ PLW GLHVHU .HQQ]HLFKQXQJ YHUVHKHQ LVW 3URGXNWH DE GHU .ODVVH ,,D VLQG ]XVlW]OLFK PLW GHU .HQQ1U GHU %HQDQQWHQ 6WHOOH  JHNHQQ]HLFKQHW

 'LH µ*HQHUHOOHQ +LQZHLVH ]XU $XIEHUHLWXQJ YRQ VWDUUHQ 5 :ROI(QGRVNRSHQ XQG =XEHK|Uµ %HVWHOO1U *$-  PV VHQ EHDFKWHW ZHUGHQ 'RUW VLQG GLH 9HUIDKUHQ GHWDLOOLHUW EHVFKULHEHQ

%HWULHEV /DJHU XQG 7UDQVSRUWEHGLQJXQJHQ %HWULHEVEHGLQJXQJHQ

 •& ELV  •&   ELV  UHO )HXFKWH  /XIWGUXFN  K3D ELV  K3D

/DJHU XQG 7UDQVSRUWEHGLQJXQJHQ

 •& ELV  •&   ELV  UHO )HXFKWH  /XIWGUXFN  K3D ELV  K3D

 8P 6FKlGHQ EHLP 7UDQVSRUW GHU 3URGXNWH ]X YHUPHLGHQ HPSIHKOHQ ZLU ]XP 9HUVDQG GLH 2ULJLQDOYHUSDFNXQJ ]X YHUZHQGHQ (QWVRUJXQJ GHV 3URGXNWHV 9HUSDFNXQJVPDWHULDO XQG =XEHK|U =XU (QWVRUJXQJ PVVHQ GLH JHOWHQGHQ OlQGHUVSH]LILVFKHQ 9RUVFKULIWHQ  *HVHW]H HLQJHKDOWHQ ZHUGHQ  :HLWHUH ,QIRUPDWLRQHQ N|QQHQ EHLP +HUVWHOOHU DQJHIRUGHUW ZHUGHQ

,PSRUWDQW JHQHUDO LQVWUXFWLRQV IRU XVH

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

&$87,21  86$ RQO )HGHUDO ODZ UHVWULFWV WKLV XQLW WR EH XVHG RU VROG H[FHSW XQGHU WKH VXSHUYLVLRQ RI D PHGLFDO GRFWRU

&RPELQDWLRQV

,I WKH YDULRXV SURGXFWV DUH XVHG LQ FRPELQDWLRQ LW LV DEVROXWHO QHFHVVDU WKDW WKH DUH FRPSDWLEOH LQ WKHLU LQWHQGHG XVH DQG UHOHYDQW WHFKQLFDO GDWD ZRUNLQJ OHQJWK GLDPHWHU SHDN YROWDJH HWF )ROORZ WKH LQVWUXFWLRQ PDQXDOV RI WKH SURGXFWV XVHG LQ FRPELQDWLRQ ZLWK WKLV SURGXFW )RU +) DSSOLFDWLRQV SOHDVH DOVR IROORZ *$6  µ,QVWUXFWLRQV RQ +) $SSOLFDWLRQµ 6PERO LQ FRQIRUPLW ZLWK 0HGLFDO 3URGXFWV 'LUHFWLYH (& 2QO YDOLG LI WKH SURGXFW DQGRU WKH SDFNDJLQJ LV LGHQWLILHG ZLWK WKLV VPERO 3URGXFWV DV RI FDWHJRU ,,D DUH DGGLWLRQDOO LGHQWLILHG ZLWK WKH FRGH QR RI WKH FRPSHWHQW GHSDUWPHQW RU DXWKRULW  

 )ROORZ WKH µ*HQHUDO LQIRUPDWLRQ RQ WKH UHSURFHVVLQJ RI ULJLG 5 :ROI HQGRVFRSHV DQG DFFHVVRULHVµ 2UGHU QR *$-  ZKHUH WKH SURFHGXUHV DUH GHVFULEHG LQ GHWDLO

2SHUDWLQJ VWRUDJH DQG VKLSSLQJ FRQGLWLRQV 2SHUDWLQJ FRQGLWLRQV

 •& WR  •&   WR  UHO KXPLGLW  $LU SUHVVXUH  K3D WR  K3D

6WRUDJH DQG VKLSSLQJ FRQGLWLRQV

 •& WR  •&   WR  UHO KXPLGLW  $LU SUHVVXUH  K3D WR  K3D

 127(

7R SUHYHQW GDPDJH GXULQJ WKH WUDQVSRUW RU VKLSPHQW RI WKH SURGXFWV ZH UHFRPPHQG XVLQJ WKH RULJLQDO SDFNDJLQJ PDWHULDO

'LVSRVDO RI WKH SURGXFW SDFNDJLQJ PDWHULDO DQG DFFHVVRULHV )RU WKH GLVSRVDO REVHUYH WKH UHOHYDQW UHJXODWLRQV DQG ODZV YDOLG LQ RXU FRXQWU  )RU IXUWKHU LQIRUPDWLRQ SOHDVH FRQWDFW WKH PDQXIDFWXUHU 5'(876&+/$1' 5,&+$5' :2/) *PE+ ' .QLWWOLQJHQ 3IRU]KHLPHUVWU  7HO     )D[    

86$ 5,&+$5' :2/) 0HGLFDO ,QVWUXPHQWV &RUS  &RUSRUDWH :RRGV 3DUNZD 9HUQRQ +LOOV ,OOLQRLV  7HO    )D[   

8. 5,&+$5' :2/) 8. /WG :DWHUVLGH :D :LPEOHGRQ 6:  +% 7HO     )D[    

%(/*,80 19 (QGRVFRSLH 5,&+$5' :2/) %HOJLXP 6$ ,QGXVWULH]RQH 'URQJHQ : /DQGHJHPVWUDDW  % *HQW 'URQJHQ 7pO     )D[    

)5$1&( 5,&+$5' :2/) )UDQFH 6$5/ 5XH 'DQLHO %HUJHU =$& /D 1HXYLOOHWWH ) 5HLPV 7pO     )D[    

$8675,$ 5,&+$5' :2/) $XVWULD *HVPE+ /HGHUHUJDVVH  $ :LHQ 7HO      )D[     

5

+HUVWHOOHU LP 6LQQH GHU 5LFKWOLQLH IU 0HGL]LQSURGXNWH (:*  0DQXIDFWXUHU LQ DFFRUGDQFH ZLWK PHGLFDO GHYLFHV GLUHFWLYH ((& )DEULFDQW WHO TX·LO HVW GpILQL SDU OD GLUHFWLYH &(( SRUWDQW VXU OHV SURGXLWV PpGLFDX[  )DEULFDQWH HQ YLUWXG GH OD GLUHFWLYD &(( UHODWLYD D ORV SURGXFWRV VDQLWDULRV

6)  ,QGH[   b0 7' 



'(876&+  (1*/,6+

,QVWUXFWLRQV JpQpUDOHV LPSRUWDQWHV SRUWDQW VXU O·HPSORL 9HLOOHU j FH TXH OH SURGXLW QH VRLW XWLOLVp TXH FRQIRUPpPHQW j VD GHVWLQDWLRQ HW HQ REVHUYDQW OH PRGH G·HPSORL HW XQLTXHPHQW SDU GX SHU VRQQHO TXDOLILp HW IRUPp j FHW HIIHW /HV WUDYDX[ G·HQWUHWLHQ HW GH UpSDUDWLRQ QH VHURQW H[pFXWpV TXH SDU GHV VSpFLDOLVWHV DXWRULVpV ,O QH IDXW XWLOLVHU OH SURGXLW TX·HQ FRPELQDLVRQ DYHF OHV DFFHVVRLUHV HW SLqFHV GH UHFKDQJH TXL VRQW PHQWLRQQpV H[SOLFLWHPHQW GDQV OH PRGH G·HPSORL UHVSHFWLI 7RXWH DXWUH FRPELQDLVRQ HW SLqFH DFFHVVRLUH GH UHFKDQJH HW G·XVXUH QH VHUD XWLOLVp TXH VRXV FRQGLWLRQ TX·HOOH VRLW H[SOLFLWHPHQW GHVWLQpH j O·HPSORL SUpYX HW QH SRUWH SDV DWWHLQWH DX[ FDUDFWpULVWLTXHV QL DX[ H[LJHQFHV HQ PDWLqUH GH VpFXULWp 3RXU SURWpJHU SDWLHQW XWLOLVDWHXU HW GHV WLHUV LO IDXW VRXPHWWUH OHV SURGXLWV DYDQW WRXW HPSORL DLQVL TX·DYDQW OH UHQYRL DX WUDLWHPHQW WHO TX·LO HVW SUpYX DX PRGH G·HPSORL 6RXV UpVHUYH GH PRGLILFDWLRQV WHFKQLTXHV  /HV LOOXVWUDWLRQV HW GRQQpHV WHFKQLTXHV SHXYHQW rWUH VXMHWWHV DX[ PRGLILFDWLRQV GXHV DX[ SHUIHFWLRQQHPHQWV WHFKQLTXHV

&RPELQDLVRQV

/·HPSORL GHV GLIIpUHQWV SURGXLWV OHV XQV DYHF OHV DXWUHV LPSOLTXH OD FRQIRUPLWp GH OD GHVWLQDWLRQ HW GHV GRQQpHV WHFKQLTXHV VLJQLILFDWLYHV FRPPH ORQJXHXU XWLOH GLDPqWUH WHQVLRQ GH FUrWH HWF ,O IDXW pJDOHPHQW REVHUYHU OHV LQVWUXFWLRQV GHV PRGHV G·HPSORL SRUWDQW VXU OHV SURGXLWV XWLOLVpV HQ FRPELQDLVRQ 3RXU OHV HPSORLV DX FRXUDQW +) YHXLOOH] HQ RXWUH REVHUYHU OHV ª ,QVWUXFWLRQV JpQpUDOHV SRUWDQW VXU O·HPSORL GX FRXUDQW GH KDXWH IUpTXHQFH ª UpIpUHQFH *$6  0DUTXDJH HQ FRQIRUPLWp DYHF OD GLUHFWLYH &(( SRUWDQW VXU OHV SURGXLWV PpGLFDX[ DSSOLFDEOH XQLTXHPHQW VL OH SURGXLW HWRX O·HPEDOODJH SRUWH OH PDUTXDJH FLFRQWUH /HV SURGXLWV FODVVLILpV GDQV OD FODVVH j SDUWLU GH ,,D SRUWHQW HQ RXWUH OD UpIpUHQFH GH O·RUJDQLVPH QRWLILp  

 9HXLOOH] REVHUYHU VYS OHV © ,QVWUXFWLRQV JpQpUDOHV SRUWDQW VXU OH WUDLWHPHQW G·HQGRVFRSHV ULJLGHV HW G·DFFHVVRLUHV GH OD 0DLVRQ 5 :ROI ª UpIpUHQFH *$-  (OOHV SRUWHQW VXU OHV GpWDLOV GHV SURFpGpV

&RQGLWLRQV GH IRQFWLRQQHPHQW GH VWRFNDJH HW GH WUDQVSRUW &RQGLWLRQV GH IRQFWLRQQHPHQW

7HPSpUDWXUH  GH •& j •&  KXPLGLWp UHODWLYH  GH  j  SUHVVLRQ DWPRVSKpULTXH  GH  K3D j  K3D

&RQGLWLRQV GH VWRFNDJH HW GH WUDQVSRUW

7HPSpUDWXUH  GH •& j •&  KXPLGLWp UHODWLYH  GH  j  SUHVVLRQ DWPRVSKpULTXH  GH  K3D j  K3D

 $ILQ G·pYLWHU WRXWH DYDULH GH WUDQVSRUW GHV SURGXLWV LO HVW UHFRPPDQGp GH OHV LPPRELOLVHU VRXV OHXU HPEDOODJH G·RULJLQH (OLPLQDWLRQ GX SURGXLW GX PDWpULHO G·HPEDOODJH HW GHV DFFHVVRLUHV

(Q FH TXL FRQFHUQH O·pOLPLQDWLRQ LO IDXW REVHUYHU OHV SUHVFULSWLRQV  ORLV QDWLRQDOHV DSSOLFDEOHV  3RXU G·DXWUHV LQIRUPDWLRQV YHXLOOH] FRQVXOWHU OH IDEULFDQW

,QGLFDFLRQHV JHQHUDOHV LPSRUWDQWHV SDUD OD DSOLFDFLyQ

(O SURGXFWR VyOR GHEH VHU HPSOHDGR FRQ DUUHJOR D VX ILQ SRU SHUVRQDV FXDOLILFDGDV FRQYHQLHQWHPHQWH LQVWUXLGDV REVHUYDQGR ODV LQ VWUXFFLRQHV SDUD HO XVR (O PDQWHQLPLHQWR ODV UHSDUDFLRQHV WLHQHQ TXH VHU UHDOL]DGRV SRU SHUVRQDV HVSHFLDOL]DGDV DXWRUL]DGDV 6H GHEH DSOLFDU HO SURGXFWR ~QLFDPHQWH HQ ODV FRPELQDFLRQHV FRQ ORV DFFHVRULRV ODV SLH]DV GH UHFDPELR LQGLFDGRV HQ ODV LQVWUXFFLR QHV SDUD HO XVR 2WUDV FRPELQDFLRQHV DFFHVRULRV SLH]DV GH GHVJDVWH VRODPHQWH VH SHUPLWHQ VL VH KDQ GHVWLQDGR H[SUHVDPHQWH D OD DSOLFDFLyQ HQ FXHVWLyQ VL QR LQIOXHQ DGYHUVDPHQWH VREUH ODV FDUDFWHUtVWLFDV GH UHQGLPLHQWR QRUPDV GH VHJXULGDG &RQ DQWHULRULGDG D FDGD DSOLFDFLyQ DQWHV GH GHYROYHU ORV SURGXFWRV QR GHMH GH VRPHWHUORV D OD SUHSDUDFLyQ GHVFULWD HQ ODV LQVWUXFFLR QHV SDUD HO XVR D ILQ GH SURWHJHU DO SDFLHQWH XVXDULR D WHUFHURV £1RV UHVHUYDPRV HO GHUHFKR GH LQWURGXFLU PRGLILFDFLRQHV WpFQLFDV 'HELGR D SHUIHFFLRQDPLHQWRV WpFQLFRV HV SRVLEOH TXH YDUtHQ XQ SRFR DOJXQDV LOXVWUDFLRQHV GDWRV WpFQLFRV

&RPELQDFLRQHV

&RQGLFLyQ SUHYLD SDUD OD DSOLFDFLyQ FRQMXQWD GH ORV GLVWLQWRV SURGXFWRV HV TXH FRLQFLGDQ HQ FXDQWR D VX ILQDOLGDG ORV SULQFLSDOHV GDWRV WpFQLFRV ORQJLWXG ~WLO GLiPHWUR WHQVLyQ GH FUHVWD HWF  1R GHMHQ GH REVHUYDUVH ODV LQVWUXFFLRQHV SDUD HO XVR UHIHUHQWHV D ORV SURGXFWRV XWLOL]DGRV HQ FRPLELQDFLyQ FRQ HVWH SURGXFWR 3DUD DSOLFDFLRQHV GH DOWD IUHTXHQFLD DGHPiV KDQ GH WHQHUVH HQ FXHQWD ODV µ,QGLFDFLRQHV SDUD OD DSOLFDFLyQ GH FRUULHQWH GH DOWD IUHFXHQFLDµ Q~P GH SHGLGR *$6   0DUFKDPR TXH VLJQLILFD OD FRQIRUPLGDG FRQ OD GLUHFWLYD &(( UHODWLYD D ORV SURGXFWRV VDQLWDULRV FRQIRUPH VRODPHQWH VL HO SURGXFWR R HO HPEDODMH HVWi SURYLVWR GHO PDUFKDPR GH DO ODGR /RV SURGXFWRV D SDUWLU GH OD FODVH ,,D DGHPiV OOHYDQ HO Q~PHUR GH LGHQWLILFDFLyQ GHO RUJDQLVPR QRWLILFDGR  

 6H GHEHQ REVHUYDU ODV µ,QGLFDFLRQHV JHQHUDOHV UHIHUHQWHV D OD SUHSDUDFLyQ GH ORV HQGRVFRSLRV UtJLGRV DFFHVRULRV GH 5 :ROIµ Q~P GH SHGLGR *$-   TXH FRQWLHQHQ XQD GHVFULSFLyQ GHWDOODGD GH ORV SURFHGLPLHQWRV

&RQGLFLRQHV GH VHUYLFLR DOPDFHQDPLHQWR WUDQVSRUWH &RQGLFLRQHV GH VHUYLFLR

 •& D  •&  KXPHGDG UHODWLYD  D  SUHVLyQ DWPRVIpULFD  K3D D  K3D

&RQGLFLRQHV GH DOPDFHQDPLHQWR WUDQVSRUWH

 •& D  •&  KXPHGDG UHODWLYD  D  SUHVLyQ DWPRVIpULFD  K3D D  K3D

 3DUD HYLWDU GDxRV HQ VXV SURGXFWRV GXUDQWH HO WUDQVSRUWH UHFRPHQGDPRV XWLOL]DU HO HPEDODMH RULJLQDO SDUD HO HQYtR (OLPLQDFLyQ GHO SURGXFWR PDWHULDO GH HPEDODMH DFFHVRULRV

&RQ UHVSHFWR D OD HOLPLQDFLyQ VH WLHQHQ TXH REVHUYDU ODV GLVSRVLFLRQHV  OHHV YLJHQWHV HQ HO UHVSHFWLYR SDtV  0DV LQIRUPDFLyQ VH OH SXHGH 9G SHGLU DO IDEULFDQWH

)5$1d$,6  (63$f2/