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KLS Martin MCO 25 plus, Инструкция по эксплуатации

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Instructions for Use 

CO

2

 Laser System MCO 25 plus 

20 

Revision 5.5 

3.9

 

Laser Safety Officer 

According to the German Accident Prevention Directive BGV B2 (Laser Radiation), the operator 
must appoint a laser safety officer in writing. This person is also responsible for the following: 

•

 

Implementation of safety measures 

•

 

Instruction of all persons working with the device in the safety measures 

•

 

Instruction of all persons using the device in the operation of the device 

•

 

Marking of the laser area with signs 

•

 

Inspection of the warning signals 

•

 

Safe storage of the keys 

•

 

Correct connection of the device in case of location changes 

•

 

Keeping of the medical product log 

3.10

 

User 

The user is responsible for safe and proper use of the medical laser system. He or she must 
ensure that all safety precautions are complied with, and be familiar with the laser-specific 
surgical technique. 

3.11

 

Electrical Safety 

The device conforms to protection class 1 (IEC 60601), which means that it must be connected 
to a properly earthed mains according to its technical data, see section 13 “Technical Data”, 
page 109. 

•

 

Use only the mains cable included in the delivery. 

•

 

Mains cable and plugs must not show any signs of damage. 

•

 

The laser system must never be activated if any part of the casing is not attached 
correctly. If the casing is not properly closed, laser radiation may escape uncontrollably, 
and dangerous electrical voltages or currents may be exposed. 

3.12

 

Grounding the Unit 

The unit is grounded via the ground conductor integrated in the mains cable. This is an 
important prerequisite for the safe operation of the unit. If the mains cable is correctly 
connected in accordance with relevant electrotechnical regulations, proper grounding is 
automatically ensured. 
The yellow-and-green equipotential bonding cable is intended for use in cases where potential 
equalization is required for laser operation (e.g. when using the Limax

®

 120 for intracardiac 

interventions). 

Содержание MCO 25 plus

Страница 1: ...English CO2 Laser System MCO 25 plus Instructions for Use 90 238 52 55 Revision 5 5 Date of Release 2015 08 Valid from software version V5 40 hardware release HW 02 and software release SW 02...

Страница 2: ...a situation which if not avoided will result in death or serious injury Follow Instructions for Use Follow Instructions for Use Reference number for ordering Gebr der Martin products item number Seri...

Страница 3: ...sportation See section 13 Technical Data page 109 for valid values Fragile avoid pressure and shock Arrows pointing up transport and store upright Manufacturing date Manufacturer Do not use if packagi...

Страница 4: ...Up 15 3 3 Laser Safety 16 3 4 Danger of Explosion and Fire 18 3 5 Protection of the Patient 18 3 6 Requirements for Treatment Rooms 19 3 7 Safety Requirements for the Laser Surgery Device 19 3 8 Safet...

Страница 5: ...Preparing the Mirror Joint Arm for Use with a Scanner 39 5 8 1 Mounting a Scanner Normal Scan 40 5 8 2 Laying the cable for the scanner 41 5 8 3 Scanner Handpiece Standard 127 mm 42 5 8 4 Scanner Han...

Страница 6: ...6 10 3 Line Scanning with Super Pulse 76 6 10 4 Super Pulse Line Scanning With Cycle 77 6 10 5 Continuous Line Scanning 77 6 10 6 Overlap 78 6 11 Memory Functions 78 6 11 1 Storing of Parameters 78 6...

Страница 7: ...ature Error 102 11 2 4 Water Flow Error 102 11 2 5 Confirming 102 11 3 Other Messages 103 11 4 System Troubles without Display Messages 104 12 Accessories 105 12 1 List of Approved Accessory Equipment...

Страница 8: ...ttlingen Germany Tel 49 7461 706 0 Fax 49 7461 706 193 info klsmartin com www klsmartin com 1 2 Scope of Delivery Laser surgery device MCO 25 plus MCO 25 plus HNO Laser surgery device MCO 25 plus Mirr...

Страница 9: ...br der Martin In addition a responsible person designated by the operator must have been instructed in the proper handling application and operation of the device as well as in its permissible combina...

Страница 10: ...ply with the operating instructions Improper handling of the device the mirror joint arm or any accessory equipment shall exclude liability by the manufacturer even for damage during the warranty peri...

Страница 11: ...t the Product Management Tel 49 7461 706 243 Fax 49 7461 706 190 Should you have any technical questions or questions concerning maintenance contracts or training courses please contact our Martin Ser...

Страница 12: ...ly In particular be sure to heed all cautions warnings and danger notices Keep this document accessible to users at all times In addition observe the Instructions for Use of the micromanipulators Mini...

Страница 13: ...g symbols and signal words WARNING Life hazard or serious injury Indicates a situation which if not avoided could result in death or serious injury CAUTION Danger of minor injury Indicates a situation...

Страница 14: ...lar requirements for the safety of diagnostic and therapeutic laser equipment IEC 60601 1 4 2001 04 4 Collateral standard Programmable electrical medical systems IEC 60601 1 6 2010 10 Usability IEC 62...

Страница 15: ...the personnel Medical product log created Registration of the device with the trade association and with the authority responsible for occupational safety Handover of the fully operational device and...

Страница 16: ...vice card respectively Instructions of use for device and accessory equipment Accident and damage reports for cases of personal injury must be reported to the relevant authorities immediately 3 3 Lase...

Страница 17: ...t directly look into the red pilot laser light The protective goggles mentioned above do not protect from the red pilot laser light Also see section 3 8 Safety Notes for the Pilot Laser page 19 During...

Страница 18: ...e and explosion must be taken If surgical interventions pose a danger of using the laser in the region of the tracheal tube which could lead to laser induced tube ignition it is mandatory to use metal...

Страница 19: ...tions They may be used only with suitable attachment filters that meet the requirements for laser protection goggles The laser system must never be turned on as long as not all parts of the casing are...

Страница 20: ...ue 3 11 Electrical Safety The device conforms to protection class 1 IEC 60601 which means that it must be connected to a properly earthed mains according to its technical data see section 13 Technical...

Страница 21: ...er safety lock remains closed until the foot switch is activated and the laser light thus released A clearly audible acoustic signal is sounded during emission of laser light Regarding the laser activ...

Страница 22: ...supervision and if safety is ensured by a qualified person and if such work is required in the context of training 3 16 Warning and Information Labels Laser class label on the rear panel see section...

Страница 23: ...plus Revision 5 5 23 3 16 1 Positions of safety notes key switch and EMERGENCY STOP switch 1 Information label to indicate the laser exit opening 2 EMERGENCY STOP switch 3 Key switch 4 Laser warning l...

Страница 24: ...System NOTICE Check laser delivery system Since the visible pilot laser light aiming beam follows the same path through the laser delivery system as the infrared laser light working beam it can be con...

Страница 25: ...rs Through the semitransparent mirror part of the laser light is coupled out and subsequently used for medical purposes Main characteristics of laser light High degree of beam parallelism beam has a v...

Страница 26: ...of the tissue thermal conductivity and thermal absorption capacity e g water content and perfusion rate There are numerous possible applications for the MCO 25 plus Apart from its low penetration dep...

Страница 27: ...e must be set up in such a way that the mains cable on the rear of the device can be disconnected quickly and easily NOTICE Danger of injuries due to electrical shock resulting from incorrect connecti...

Страница 28: ...wing section Unblock the 2 front casters before any transport The cooling water of the laser is frost proof down to a temperature of 10 C 14 F Do not transport the MCO 25 plus laser at temperatures of...

Страница 29: ...e CO2 Laser System MCO 25 plus Revision 5 5 29 5 4 Front Side 1 Display and control panel 2 EMERGENCY STOP switch 3 Key switch 4 Warning labels 5 Laser surgery device MCO 25 plus 6 Focusing handpiece...

Страница 30: ...2 Mains Fuses 6 Connection socket for foot switch 3 Cable clamp 7 Type plate 4 Socket for interlock connector 5 5 1 Type Plate The type plate 7 Fig 5 1 can be found on the back of the device It contai...

Страница 31: ...round wire NOTICE Do not use splitting boxes or extension cords 5 5 3 Equipotential Grounding Pin The device can be connected to the potential equalization system in the operating theater at the equip...

Страница 32: ...UTION Risk of injury by accidental laser activation The foot switch is equipped with magnetic reed contacts Magnetic fields in the immediate vicinity can cause accidental activation of the foot switch...

Страница 33: ...Fig 5 1 If the interlock connector is plugged into the foot switch socket operation is not possible An message appears on the display The laser surgery device cannot be switched into LASER READY mode...

Страница 34: ...STANDBY mode The laser treatment can be continued without interruption 5 6 Preparing the MCO 25 plus Laser for Attaching the Mirror Joint Arm Unscrew protection cap from the thread 1 Remove gray cap...

Страница 35: ...the spring force by means of a latch 2 during transport In mounted state this latch allows force free movement the arm and return to the upright parking position when not used Fig 5 3 Transport positi...

Страница 36: ...rt of the arm to be plugged into the laser surgery device 2 Arm latch locked unlocked Working position locked Arm remains in upright position 3 Setting for spring tension handpiece scanner normal spri...

Страница 37: ...After mounting the arm it must be secured by engaging the latch By doing so unintentional loosening of the arm in the thread which would result in imprecise beam generation can be avoided Turn latch 4...

Страница 38: ...focused which bears significant hazard potential Preparing the arm for the focusing handpiece Ensure that the lever 2 is set to handpiece Note the lever 2 is set to handpiece by factory default Unscre...

Страница 39: ...the stronger value Unburden the mirror joint arm by pulling it towards the user Change arm latch 1 from locked position to unlocked position Swivel arm slightly backwards until adjusting lever 2 can...

Страница 40: ...and scanner handpieces 6 Connection socket for control cable MICRO POINT R NOTICE Damage to activated device The scanner and laser must never be connected or disconnected electrically while the device...

Страница 41: ...long the mirror joint arm Leave enough room for the cable on the joints of the arm Only thus is unimpeded movement of the arm possible 2 Scanner cable connection on scanner 3 Flushing air hose connect...

Страница 42: ...anner handpiece 127 mm Power 10 25 W Figure size 2 8 mm Scan shapes Triangle rectangle square hexagon ring line Scan speed low middle high The scan speed defines the dwell time of the laser at the app...

Страница 43: ...n 5 8 1 Mounting a Scanner Normal Scan page 40 For fractionated scanning the scanner handpieces SOFT FRAC and POWER FRAC are used Fig 5 10 Fractionated scanner for the MCO 25 plus A Scanner casing Sof...

Страница 44: ...ilts slightly forwards Tighten setting screw of the rotary fixation 2 Rotation of the mirror joint arm is prevented For use of the laser surgery device the arm can be removed from the holder by slight...

Страница 45: ...parallel position to the floor at position 2 Keep holding the arm at 3 and it move forwards in a curve Press arm into lateral holder 5 The mirror joint arm is secured The laser surgery device can now...

Страница 46: ...authorized use If the device is not being used remove the key and store it in a safe location 6 1 Switching on the Device CAUTION All persons present in the laser room must wear laser protection goggl...

Страница 47: ...ely The device is not de energized The switch locks in place when pressed Deactivating the EMERGENCY STOP Turn EMERGENCY STOP switch to the right or to the left until the latch unlocks and the red swi...

Страница 48: ...ed by entering the pulse duration and pulse frequency 6 4 1 Changing Modes Simultaneously press the key STANDBY when switching on the device with the key switch The options TIME SETUP time mode and FR...

Страница 49: ...When switching on the device with the key switch keep the SELECT key pressed until a selection list of the available languages appears on the display Use the arrow keys to move the cursor to the desir...

Страница 50: ...y pad Fig 6 2 Operating panel with display showing starting screen and key pad After turning the key switch the MCO 25 plus shows a starting screen on the display It displays the KLS Martin logo and t...

Страница 51: ...y M3 STANDBY laser operation not possible Memory M4 PILOT pilot laser on off Memory M5 LASER READY MCO 25 plus is ready for laser light activation TRIANGLE scan shape triangle CW continuous laser outp...

Страница 52: ...se operation D Display and display elements P Keys for parameter pre settings and navigation S Keys for STANDBY PILOT und LASER READY M Memory keys F Function keys for operation mode selection C Scann...

Страница 53: ...are shown Fig 6 4 Control panel with display in Frequency Mode CW and pulse operation D Display and display elements P Keys for parameter pre settings and navigation arrow keys S Keys for STANDBY PIL...

Страница 54: ...during power check P1 Selection of laser parameters This key cyclically scrolls through the parameters shown on the display from top to bottom The selected parameter appears inverted on the display P...

Страница 55: ...Function key lit yellow C1 Scan shape triangle Selects the scanner function repeated pressing rotates the triangle by 90 counterclockwise Scanner key lit yellow single scan periodic with F5 MCO 25 plu...

Страница 56: ...treated area light 20 medium 50 strong 80 D4 Cycle length Duration of a cycle in ms or s 0 1 10 s F3 F4 D4 C Handpiece Selects the scanner handpiece Scanner handpiece 127 and 200 mm micromanipulators...

Страница 57: ...ible with the MCO 25 plus This laser mode is often called CW continuous wave Parameters in Continuous Operation Power output average power Use the SELECT key to select the field POWER Increase or decr...

Страница 58: ...peatedly when the key is held down The selected value is shown on the LCD display Setting range 10 25 W in steps of 1 W Pulse duration Use the SELECT key to select the field PULSE duration of power In...

Страница 59: ...f 1 W Pulse duration The pulse duration is set as in single pulse mode see section 6 6 2 Single Pulse Mode page 57 Setting range 5 ms 10 s Pulse pause Pause Use the SELECT key to select the PAUSE fiel...

Страница 60: ...To In steps of 0 1 s 1 s 0 1 s 1 s up to 10 s 1 s Setting ranges for cycle pause From To In steps of 0 1 s 1 s 0 1 s 1 s 10 s 1 s Setting ranges for cycle rate From To In steps of 0 1 Hz 10 Hz 0 1 Hz...

Страница 61: ...h is activated the laser generates a sequence of short light pulses in the set intervals until the foot switch is released again Only the pulse intervals and the pulse frequency can be set on the disp...

Страница 62: ...splay L1 Laser emission display D1 Maximum power P1 Select key D2 Size of scan shape P2 P3 Adjustment keys D3 Scanner speed M1 M5 Memory keys D4 Focal length of scanner handpiece F1 F4 Operating mode...

Страница 63: ...ring 4 8 mm 6 13 mm Straight line 1 6 mm 1 9 mm Curved line 1 6 mm 1 9 mm Strongly curved line 1 6 mm 1 9 mm Tab 6 4 Figure size of scan shapes for scanner handpieces NOTICE The energy density is the...

Страница 64: ...in the selectable pause time The pause time can be set to OFF for forced ablation using the scanner To do this reduce the time by pressing the key until OFF appears Energy density The field D7 Fig 6...

Страница 65: ...ection SOFT FRAC Setting ranges POWER 10 25 W FIGURE SIZE 2 10 mm SCAN SHAPES Triangle rectangle polygon FILL FACTOR LIGHT 20 of area filled MEDIUM 50 of area filled STRONG 80 of area filled Energy de...

Страница 66: ...AC to the scanner and select the setting POWER FRAC in the menu HAND PIECE When using the scanner the laser generates a surface filling number of spots with a diameter of 0 2 mm Setting POWER FRAC exa...

Страница 67: ...r use with scanner casing Soft Scan Plus R Connect micromanipulator to the scanner casing Soft Scan Plus R using the red adapter connector included in the delivery see section 6 10 1 Connection page 7...

Страница 68: ...mm 4 15 mm 4 18 mm 5 21 mm 6 24 mm Square 3 12 mm 4 15 mm 4 18 mm 5 21 mm 6 24 mm Rectangle 6 12 mm 7 15 mm 9 18 mm 10 21 mm 12 22 mm Hexagon 3 12 mm 4 15 mm 4 18 mm 5 21 mm 6 24 mm Circle 3 12 mm 4 1...

Страница 69: ...J cm Scanning speed MICRO POINT 225 mm 10 25 10 25 10 14 6 8 17 14 34 27 38 HIGH MIDDLE LOW MICRO POINT 250 mm 10 25 10 25 10 17 5 5 14 11 27 22 37 HIGH MIDDLE LOW MICRO POINT 300 mm 10 25 10 25 10 23...

Страница 70: ...cal length of the MICRO POINT 2 2R in the menu HAND PIECE This setting combined with the different scan shapes allows minimal laser areas down to 0 4 mm The following table shows the different figure...

Страница 71: ...ctivated as long as the foot switch is pressed 6 9 2 CYCLE CYCLE PAUSE Setting TIME MODE Setting range 10 ms 10 s CYCLE RATE Setting FREQUENCY MODE Setting range 0 1 5 Hz Fig 6 10 Setting CYCLE SCAN h...

Страница 72: ...r handpiece D5 Cycle pause option when F5 is held down D6 Pilot laser brightness D7 Resulting energy density D8 Type and orientation of line C5 Selection key for line scanning press repeatedly to sele...

Страница 73: ...OTICE The angle setting of the line on the display does not match that in the operation area It depends on the position of the laser relative to the user and on the current position of the scanner as...

Страница 74: ...Scanner casing Soft Scan Plus R 5 MICRO SWITCH 3 Control socket for MICRO SWITCH connector Connect Soft Scan Plus R 2 to the mirror joint arm see section 5 8 1 Mounting a Scanner Normal Scan page 40 I...

Страница 75: ...ght or curved line and its orientation can be done via the micromanipulator Fig 6 13 Micromanipulator MICRO POINT 2R with MICRO SWITCH 1 Key for clockwise rotation 2 Key for selection of line curve 3...

Страница 76: ...shapes you can also use the super pulse mode instead of continuous laser light Press the SUPERPULSE key F4 and then directly the line key C5 This function is shown next to the scanning line on the di...

Страница 77: ...e line is scanned cyclically as long as the foot switch is activated Between every scan the laser is stopped for the duration of the cycle pause time 6 10 5 Continuous Line Scanning The cycle pause ca...

Страница 78: ...aps 6 11 Memory Functions 6 11 1 Storing of Parameters NOTICE When switching from Time Mode to Frequency Mode and back the stored parameters are lost The names of the storage locations can be carried...

Страница 79: ...ocation The menu allows deleting existing names changing them or entering a new name for the memory location The following message is displayed DO YOU WANT TO ENTER NEW TEXT Option NO the existing nam...

Страница 80: ...r number S1 STANDBY key used to delete a letter or number After entry select the field STORE and confirm by pressing SELECT key P1 The MCO 25 plus laser accepts the name and the parameters and saves t...

Страница 81: ...he message PLEASE CONNECT SCANNER By pressing the STANDBY key S1 Fig 6 3 page 52 the message can be deleted Install scanner only when laser is switched off The stored parameters appear on the display...

Страница 82: ...aser but are not effective against the red pilot laser light Do not look directly into the pilot laser light Point the pilot laser light to a bright surface The pilot laser beam must regardless of the...

Страница 83: ...pressing the key LASER READY S3 the red pilot laser beam is automatically switched on The yellow lamp on the PILOT key S2 indicates that the pilot laser is activated 6 12 2 Deactivating the Pilot Las...

Страница 84: ...key a second time within 3 s If the key is not pressed a second time within 3 s the pilot laser remains activated If the key is pressed a second time within 3 s the pilot laser is deactivated You can...

Страница 85: ...ndpiece is pointed at the operation area and all measures to avoid laser induced fires and explosions described above are complied with NOTICE Risk of damage to optics of the focusing handpiece Make s...

Страница 86: ...anently lit yellow CAUTION Danger of physical injury due to wrong parameters Before activating the foot switch on the control panel check the set parameters once more Switch on the laser light by pres...

Страница 87: ...the MCO 25 plus is switched on the display shows the starting screen for about 10 s It shows the KLS Martin logo and the software version Check the blue display for screen errors After a system check...

Страница 88: ...til the display appears correctly The contrast of the LCD display can be adjusted and adapted to the ambient conditions Press and hold the SELECT key Additionally press one of the 2 arrow keys The key...

Страница 89: ...plus to a separate mains socket Put on protective goggles Protect the eyes of the patient Mark the laser area Close the doors of the treatment room Activate warning lamps Check Unlock EMERGENCY STOP s...

Страница 90: ...ER READY button MCO 25 plus is ready LED is lit yellow Activate foot switch Actuate foot switch and apply laser light Apply laser light Setting laser unit to STANDBY Press STANDBY key MCO 25 plus is n...

Страница 91: ...each surgery Hospital staff Cleaning and disinfecting the unit s external surfaces after each surgery Hospital staff Inspection of the electrical connections and cables for potential defects every 6...

Страница 92: ...sing handpiece and the mirror joint arm be emitted centrally from the focusing handpiece There must be no diffused red light 8 2 2 Test of the Optical System Use laser with focusing handpiece f 127 mm...

Страница 93: ...with WARNING Risk of serious injury from defective accessories A non functional unit or defective accessories can endanger the patient or user as well as affect the intended functions of the unit The...

Страница 94: ...ption Optics and optical application parts must be checked for transmission before use To this purpose the pilot laser light can be used NOTICE After the cleaning process the angular pieces and the EN...

Страница 95: ...e wiping Replace optics if the degree of soiling is too high or if they are damaged Do not dispose of optics as normal household waste Defective optics will be disposed of by the technical service of...

Страница 96: ...e REF 1 Tip 2 Tube 3 Optics A Scanner 127 mm 76 500 50 04 76 500 51 04 76 500 52 04 76 500 53 04 B Scanner 200 mm 76 500 60 04 76 500 61 04 76 500 62 04 76 500 63 04 9 2 Parts of the Angles Illustrati...

Страница 97: ...e CO2 Laser System MCO 25 plus Revision 5 5 97 9 3 Parts of the ENT Set Illustration ENT set REF A Optics 76 600 01 04 B Tube 76 600 11 04 Attachment 0 76 600 02 04 Attachment 90 76 600 03 04 Attachme...

Страница 98: ...top 127 mm 76 100 20 04 Backstop 200 mm 76 100 25 04 Adapter 76 200 15 04 Angle 120 76 200 10 04 Angle 90 76 200 05 04 ENT handpiece tube 76 600 11 04 ENT attachment 0 76 600 02 04 ENT attachment 90 7...

Страница 99: ...O 17665 1 2006 ANSI AAMI ST79 recommends a minimum cycle time of 4 min at 132 C 270 F for dynamic air removal steam sterilization cycles Please follow the instructions of the user manual of your steam...

Страница 100: ...Scanner handpiece 200 mm 76 500 61 04 76 500 62 04 Scanner handpiece SOFT FRAC 76 501 38 04 76 501 08 04 Scanner handpiece POWER FRAC 76 502 31 04 76 502 21 04 Backstop 127 mm 76 100 20 04 Backstop 20...

Страница 101: ...1 Interlock Error The message INTERLOCK ERROR appears on the display There are 2 possible causes for this message The external interlock circle is interrupted It is closed by plugging the interlock c...

Страница 102: ...e any faults in the cooling water flow cycle the message WATER FLOW ERROR is displayed This message often appears in case of air bubbles in the cooling water cycle Keep the laser activated for a while...

Страница 103: ...Maximum power D7 current power The current power output is used for the application as usual Should the message that prompts the user to confirm the current power output appear more often than expect...

Страница 104: ...h and pull out No laser emission when pressing the foot switch 1 Foot switch is not connected Connect foot switch 2 Device is in STANDBY mode Set device to Laser Ready Pilot laser light is not visible...

Страница 105: ...aser protection goggles CO2 for spectacle wearers D 9000 11000 L4 RH DIN CE acc to 89 686 EEC PPE 76 100 51 04 Laser protection goggles CO2 and Nd YAG D 1060 L6 RH DIN CE acc to 89 686 EEC PPE DI 10 6...

Страница 106: ...Foot Switch for CO2 Laser system MCO 25 plus 77 200 00 04 12 5 Scanner Description REF Add on kit scanner Soft Scan Plus R for MCO 25 plus 76 500 00 04 Scanner installation 76 500 20 04 Scanner head...

Страница 107: ...Storz laparoscope 76 500 43 04 12 7 Micromanipulators MINI POINT Description REF Micromanipulator MINI POINT gynecology 76 400 00 04 Adapter system Zeiss for MINI POINT 76 400 10 04 Adapter system Ka...

Страница 108: ...ith the MCO 25 plus laser the following safety distances NOHD nominal ocular hazard distance must be observed If these distances are exceeded the allowed limit values for laser treatment and radiation...

Страница 109: ...mrad without focusing handpiece Laser tube sealed off DC excited Minimum tube lifetime 2 000 h max 24 months Pilot laser wavelength 635 nm Class of pilot laser 3R diode laser Pilot laser power 5 mW c...

Страница 110: ...l 55 dB A at full load 55 dB A Dimensions H W D 1 180 290 450 mm mirror joint arm retracted 2 000 290 450 mm mirror joint arm in working position Weight 57 kg Ambient conditions for transportation and...

Страница 111: ...s Device class MDD IIb Serial number Inv number Operating hours Operator Location Tests as in IEC 62353 section 5 1 to 5 3 NOTICE To avoid damaging the device measuring the insulation resistance is no...

Страница 112: ...0601 1 4 1 Protective grounding conductor resistance 0 2 4 2 Ground leakage current 0 5 mA 5 Measurement of the safety relevant output parameters 5 1 Check calibration with external power meter accept...

Страница 113: ...mpliance level Electromagnetic environment Guidance RF emissions according to EN 55011 Group 1 The device uses RF energy only for its internal function Therefore RF emission is very low and it is unli...

Страница 114: ...typical commercial or hospital environment Surge according to IEC 61000 4 5 1 kV voltage phase phase 2 kV voltage phase earth 1 kV voltage phase phase 2 kV voltage phase earth Mains power quality sho...

Страница 115: ...separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b Interfere...

Страница 116: ...t P of transmitter in watts 150 kHz to 80 MHz P d 17 1 80 MHz to 800 MHz P d 17 1 800 MHz to 2 5 GHz P d 33 2 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 7 3 7 7 4 100 11 7 11 7 23 3...

Страница 117: ...ecific user instructions 16 3 Disposal In designing the device we tried to avoid using composite materials wherever possible This allows a high degree of recycling We therefore offer to take the devic...

Страница 118: ...5820 6251 china klsmartin com Martin Nederland Marned B V 1270 AG Huizen The Netherlands Tel 31 35 523 45 38 nederland klsmartin com KLS Martin L P Jacksonville Fl 32246 USA Tel 1 904 641 77 46 usa kl...

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