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Manual

C-PRO

21 

5.7  CE Regulations 

The  C-Pro  micromanipulator  was  accredited  by  the  notified  body  in  accordance  with  the 
European directive 93/42 for medical equipment. Therefore, the device is labeled with the 
CE mark.  

The device was tested for mechanical safety. All parts used by A.R.C. Laser for the WOLF 
Laser comply with CE regulations. 

Any additional equipment that needs to be attached to the device must require the official 
approval  of  the  local  inspection  authority.  No  modifications  for  the  device  are  allowed  as 
these may have a serious risk potential and will void the regulatory approval as well as the 
warranty. 

A device book and the test approval number are included with the device. 

5.8  RoHS2 Regulations 

Our  company  operates  worldwide  and  considers  the  protection  of  the  environment  and 
natural  resources  as  a  corporate  obligation.  Based  on  individual  tests  we  can  for  the 
products  of  ARC  Laser  GmbH  confirm  that  these  substances  are  not  present  in 
concentrations  according  to  our  knowledge,  the  marketing  of  which  is  prohibited  in 
accordance with the applicable requirement of Directive 2011/65/EG (RoHS2).  

5.9  Stickers Labels and Markings 

The  C-Pro  has  various  warning  labels  in  accordance  with  the  European  directives  and 
Health Canada, intended to prevent any laser users to become exposed to laser radiation 
because  of  improper  use.  You  can  identify  the  arrangement  of  these  labels  with  the 
following drawings. 

IDENTIFICATION PLATE 

Manufacturer

 



Date of 
manufacturing 

Serial number

no disposal in

domestic waste 

See Manual

Warning label  

Warning label laser beam 

Modification label  

Indicates the actual modification state of C-Pro  

Содержание C-Pro

Страница 1: ...User Manual C Pro Micromanipulator Medical Device A R C LASER GmbH Bessemerstr 14 90411 N rnberg Germany phone 49 911 21779 0 fax 49 911 21779 99 info arclaser de...

Страница 2: ...t A R C LASER GmbH Bessemerstr 14 D 90411 N rnberg Germany TEL 49 911 21779 0 FAX 49 911 21779 99 Revision Date Nov 22 2017 File Manual_C PRO_10600nm_rev3 docx Revisions Date 12 10 2020 Author Christi...

Страница 3: ...or 12 4 4 Connecting the C Pro to the Surgical Microscope 12 4 4 1 Microscope compatibility 12 4 4 2 Connecting the C Pro 13 4 5 Connecting the Micromanipulator to the Laser 14 4 5 1 Connecting the ar...

Страница 4: ...trolling the laser beam 29 7 4 Dismantling 29 7 5 Quick guide 30 7 6 C Pro performance test after installation 30 8 TECHNICAL DATA 31 8 1 Dimensions 31 8 2 General 31 9 SERVICE 32 9 1 Introduction 32...

Страница 5: ...ntire user manual without an explicit written consent by A R C Laser GmbH Approved copy or parts extracted from this user manual as licensed by A R C Laser GmbH shall include references to the origina...

Страница 6: ...laser beam The main fields of application are indications in the field of ENT and gynecology CAUTION The device may only be operated by specially trained personnel who have knowledge of the medical e...

Страница 7: ...the beam in the field of vision Fig 1 Beam path at the micromanipulator 2 2 Mirror and Lens Based Systems Micromanipulators are divided into mirror based and lens based systems depending on their stru...

Страница 8: ...e C Pro instead of lenses as is common with many other manufacturers If the operating field is very weakly illuminated two target beams may be seen due to the light refraction at the deflecting mirror...

Страница 9: ...or the connection and the application of the micromanipulator see figure 4 Note The C Pro and all accessories should always be stowed in the appropriate recesses in the case after use The joystick and...

Страница 10: ...ease inform A R C Laser GmbH as soon as possible in case parts are missing or damaged 3 3 Storage Conditions Transport and storage conditions Temperature 10 C to 60 C Relative humidity 5 85 The C Pro...

Страница 11: ...o light up when the laser is in operation This ensures warning to prevent accidental entry to the room without protective goggles Please store the laser protective goggles at the entrance of the room...

Страница 12: ...t the top and the underside of the deflection mirror for burn in and contamination Hold the micromanipulator in a firm grip 4 Note Never touch the coated side of the deflection mirror 5 If cleaning is...

Страница 13: ...see figure 5 3 Push The dovetail adapter attached to the micromanipulator into the adapter plate so that the lens of the microscope is located centrally above the housing of the micromanipulator As a...

Страница 14: ...e thread adapter Make sure the articulated arm is in the correct position see figure 7 8 The articulated arm is taken out of the holder by means of slight pressure of the two fingers so that the conne...

Страница 15: ...trated operating area The laser must be positioned in such a way that the articulated arm is within the operating range shown in figure 10 4 6 2 Angular position of the articulated arm The two arms of...

Страница 16: ...line with the angular range mark red green red label on the first leg see figure 11 right After the laser has been placed in the positions described in 4 5 1 and 4 5 2 the laser and the operating mic...

Страница 17: ...r In addition you can refer to the regulations of the American National Standard Agency ANSI Z136 3 1996 American National Standard for the Safe Use of Lasers in Health Care Facilities and ANSI Z136 1...

Страница 18: ...protected from catching fire This can be achieved by the use of fire resistant instruments venturi ventilation humidification and non burning gas mixtures The anesthesia staff should use fire resistan...

Страница 19: ...address reorders to A R C Laser GmbH indicating the wavelength or the item number of the goggle Should you require any additional information on protective goggles please contact your local A R C Las...

Страница 20: ...materials as this may cause a fire The pedal switch controlling the laser Pulse should never be outside the range of the operator holding the laser hand piece fiber It is prohibited that any person ot...

Страница 21: ...company operates worldwide and considers the protection of the environment and natural resources as a corporate obligation Based on individual tests we can for the products of ARC Laser GmbH confirm t...

Страница 22: ...been tested for operation in heights exceeding 2 000 m above sea level The following ambient conditions must be met Operating conditions Temperature 15 C to 35 C Relative humidity 75 not condensing A...

Страница 23: ...n training all trained persons are mentioned in the device book wherein a person as responsible for the security is registered This person is subsequently entitled to instruct other people on the unit...

Страница 24: ...s equipped with the following components see figure 13 Fig 13 Components on the C Pro connection for articulated arm adapter positioning ring operating distance dovetail focusing defocussing lever def...

Страница 25: ...na Vario 1 x ME02157 thread adapter for articulated arm 1 x ME12033 hand rest long 1 x VP12000 transportation case C Pro 1 x ZU01084 cleaning set selected when ordering For information on accessories...

Страница 26: ...the beam diameter is set the lower the energy density for the same laser parameters The power density is defined by the following formula with The unit of is In the table below the energy densities a...

Страница 27: ...cused before the target beam can focused see figure 14 3 Get the laser ready Press the grey button standby in the lower right corner of the display It will change into yellow button ready 4 The desire...

Страница 28: ...this lever position for tissue cutting Moving the lever in the direction D defocused will cause an increase in the beam diameter A defocused beam is used for coagulation and vaporization of tissue In...

Страница 29: ...ted by turning the cap Fig 17 C Pro from the surgeon s perspective left focus defocus center joystick right hand rest The size of the operating area depends on the operating distance Minimum 50 x 30 m...

Страница 30: ...be adjusted as required 7 6 C Pro performance test after installation To ensure that the C Pro is working well please perform the following test routine after installation 1 Put a wooden spatula in f...

Страница 31: ...dth x height Weight 570 g 8 2 General Designation Micromanipulator Type C Pro Transmission 70 5 Wavelength CO2 laser 10600 nm Maximum power CO2 laser 30W CW 10W CW Super Puls Operating distance 200 50...

Страница 32: ...trained by A R C Laser GmbH This includes also any type of optics cleaning within the laser system This includes also any type of optics cleaning within the laser system 9 2 Care and Maintenance by th...

Страница 33: ...ning set ZU01084 Pre cleaning For cleaning the mirror please turn the micromanipulator over so that the underside of the deflecting mirror points upwards Fig 20 Position of the C Pro at the beginning...

Страница 34: ...eflecting mirror by means of lens cleaning tissue 2 The cleaning tissue should overlap on the side facing the observer so that the observer can hold the tissue with the tweezers without touching the m...

Страница 35: ...he lens cleaning tissue may only be used once a fresh tissue should be used for each additional cleaning operation The steps described should be repeated as often as necessary until the mirror surface...

Страница 36: ...ination of the operating area Explanation see chapter 7 1 No target beam Switch on the laser Activate the target beam Check the operating distance of the adjusting ring Micromanipulator is loose Check...

Страница 37: ...sing of the device shall be passed on to A R C Laser GmbH within 24 hours Parts returned during the warranty period upon the explicit request of A R C Laser GmbH are subject to the written confirmatio...

Страница 38: ...Manual C PRO 38 Notes...

Страница 39: ...Manual C PRO 39 Notes...

Страница 40: ...Manual C PRO 40...

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