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KLS Martin diomax, Инструкция по эксплуатации

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Instructions for Use 

Laser Surgical Unit diomax

®

 

 

Revision 6 

7 

1

 

Product Liability and Warranty 

1.1

 

General Information 

We thank you for having decided to buy a KLS Martin product. This product carries the 
CE mark, which means that it satisfies the essential requirements laid down in the EC Directive 
concerning medical devices. 
We are the manufacturer of this product: 

Gebrüder Martin GmbH & Co. KG 
A company of the KLS Martin Group 
KLS Martin Platz 1 · D-78532 Tuttlingen · Germany 
Postfach 60 · D-78501 Tuttlingen · Germany 
Tel. +49 7461 706-0 · Fax +49 7461 706-193 
[email protected] · www.klsmartin.com 

1.2

 

Scope of Delivery 

•

 

Laser surgical unit diomax

®

 

•

 

Power supply cable 

•

 

2 keys 

•

 

Equipotential bonding cable 

•

 

diomax

®

 Instructions for Use 

•

 

Interlock connector with bypass 

•

 

Footswitch 

•

 

2 laser warning signs 

•

 

Medical product log 

Содержание diomax

Страница 1: ...English Laser Surgical Unit Instructions for Use 90 336 52 50 Revision 6 Date of Release 2019 07 Valid for software version V5 00 hardware release HW 03 and software version SW 04...

Страница 2: ...use Follow instructions for use Item number Item no Serial number Store in a place protected from direct sunlight Store in a dry place Information on minimumand maximum temperature for storage and tra...

Страница 3: ...oid pressure and shock Arrows pointing up transport and store upright Manufacturing date Manufacturer Do not use if packaging is damaged CE mark of conformity This product may not be disposed of as no...

Страница 4: ...3 2 Installation and Initial Commissioning 14 3 3 Laser Safety 16 3 4 Danger of Explosion and Fire 17 3 5 Protection of the Patient 17 3 6 Requirements for Treatment Rooms 18 3 7 Safety Requirements...

Страница 5: ...3 5 1 6 Display 34 5 1 7 Rotary Knob with Ring Light 35 5 1 8 Laser Status Display 36 5 2 Connecting Laser Fibers 37 5 3 Checking the Laser Fiber Using the Pilot Laser 38 5 4 Replacing the Laser Fiber...

Страница 6: ...g and Disinfecting 64 9 Troubleshooting 65 9 1 Messages on the Display 65 9 2 Other Malfunctions 65 10 Accessories 66 10 1 Safety Distances NOHD 66 11 Tecnical Data 67 12 Safety Check SC 69 13 Guideli...

Страница 7: ...cerning medical devices We are the manufacturer of this product Gebr der Martin GmbH Co KG A company of the KLS Martin Group KLS Martin Platz 1 D 78532 Tuttlingen Germany Postfach 60 D 78501 Tuttlinge...

Страница 8: ...e laser surgery device may be used only in rooms intended for medical purposes that are marked as laser rooms The operator may operate the device only if an on site functional test has previously been...

Страница 9: ...horized by Gebr der Martin to perform such work If the repair is carried out by a person or firm specially authorized by Gebr der Martin the operator of the product is required to obtain from the repa...

Страница 10: ...ce Center Tel 49 7461 706 343 Fax 49 7461 706 408 E Mail service klsmartin com Should you have any questions concerning maintenance contracts or training courses please contact our Technical Service M...

Страница 11: ...These instructions for use are valid for software version V5 00 or higher hardware release HW 03and software version SW 04 The software version currently installed in your diomax is indicated on the i...

Страница 12: ...mbols and signal words WARNING Danger of death 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 13: ...IEC 60601 2 22 1996 12 Medical electrical equipment Particular requirements for the safety of diagnostic and therapeutic laser equipment IEC 60601 1 4 2001 04 4 Collateral standard Programmable electr...

Страница 14: ...device with the trade association and with the authority responsible for occupational safety Handover of the fully operational device and training of the personnel by Gebr der Martin or an authorized...

Страница 15: ...ted annually and must be documented by the users in written form When the device is not in use it must be protected against unauthorized use Remove key and store it in a safe location Operation mainte...

Страница 16: ...aser beam may be deflected unintentionally Therefore the following safety precautions must be strictly complied with All accesses to the laser areas must be marked with warning lamps Persons working i...

Страница 17: ...als cannot ignite Therefore oxygen must not be used as flushing medium in endoscopic applications When laser light is used in areas of organs body cavities and tubi that may contain flammable gases or...

Страница 18: ...finish to eliminate dangerous reflections as far as possible Optical systems for observation of the operation area must be designed for laser applications They may be used only with suitable attachmen...

Страница 19: ...er 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 d...

Страница 20: ...ssed any longer the emission of laser light is stopped immediately even if the preset pulse time has not ended yet The foot switch has two switches one for accessory devices and one for the laser acti...

Страница 21: ...maximum output values of the laser light For further Technical Data please also see section 11 Tecnical Data page 67 Laser warning label Information label for class 4 lasers Information label marking...

Страница 22: ...r user CAUTION Dangerous laser radiation Dangerous laser radiation may escape when the laser fibers are strongly bent beam exit on the side breaking of the fiber Be careful when using laser fibers tha...

Страница 23: ...ns make sure that the device temperature has adapted to the ambient temperature before starting the device Set up the device on a level surface such as a table or cart The device must securely stand o...

Страница 24: ...il in section 5 1 Control and Display Elements page 30 4 4 Rear of Device 1 Type plate 6 Accessory Port connection 2 Mains connection with fuses 7 Service interface 3 Equipotential grounding pin 8 Opt...

Страница 25: ...otential Grounding Pin The device can be connected to the potential equalization in the operating room via the equipotential grounding pin using the equipotential grounding cable included in the scope...

Страница 26: ...interlock Solder side of the 7 pin plug Interlock Warning Laser warning lamp contact This contact activates the warning lamps when switching on the device key switch on I All accesses to the laser ar...

Страница 27: ...the LASER READY key 2 The laser treatment can be continued See also section 9 Troubleshooting page 65 CAUTION Possible danger to the patient in case of connection of the door interlock Connecting the...

Страница 28: ...o control accessory components 4 4 7 Service Interfaces The device is equipped with interfaces for service work by authorized service personnel This connection is not suitable for user devices 4 4 8 O...

Страница 29: ...ly protective goggles for all persons in the laser area including the patient WARNING Danger of fire Avoid use of flammable anesthetics or oxidizing gases such as nitrogen oxide N2O and oxygen Materia...

Страница 30: ...described in this document can lead to dangerous radiation 5 1 Control and Display Elements 1 EMERGENCY STOP switch 5 Display 2 SMA X fiber connection socket 6 Rotary knob 3 Laser signal light 7 Key s...

Страница 31: ...diately stops the emission of laser light Press EMERGENCY STOP switch The switch locks in place The device can be switched on again after pulling out the switch 5 1 3 SMA X Fiber Connection Socket The...

Страница 32: ...tch not activated Red Laser fiber not connected Yellow LASER READY and activated foot switch Laser light emission Permanent yellow light During continuous laser operation as long as the foot switch is...

Страница 33: ...le laser fiber is connected The pilot laser is automatically activated 3 PILOT key Pressing the pilot key activates deactivates the pilot laser in STANDBY mode if a laser fiber is connected Deactivati...

Страница 34: ...se duration seconds Pulse pause seconds Cycle seconds Cycle pause milliseconds Active field 4 The highlighted field orange shows the parameter that can currently be modified Laser status display 6 see...

Страница 35: ...pressing the key LASER READY Pressing activates the rotary knob and switches the laser into STANDBY mode not ready unless the foot switch is activated White Rotary knob active Parameter fields can be...

Страница 36: ...Laser STANDBY A suitable laser fiber is connected The laser can be adjusted but not activated LASER READY The laser is ready for the emission of laser light Laser light can be emitted by activating t...

Страница 37: ...ctive cap from the SMA X plug of the supply fiber Check if the coupling side on the SMA X plug is damaged or dirty Visually check the optics of the focusing handpiece Observe the instructions for use...

Страница 38: ...r damages If red pilot laser light escapes laterally this is an obvious sign that the fiber is damaged Perpendicularly point the pilot laser from a distance of about four centimeters about 1 onto a br...

Страница 39: ...nnection socket using the SMA X plug Tighten the cap nut manually Fully screw on fiber even if the red signal lamp turns dark earlier The display shows LASER STANDBY in green color If the laser fiber...

Страница 40: ...is switched on and performs a self check for 10 30 s The blue starting screen shows the KLS Martin and diomax logo and the software version e g 5 00 in the example on the left After the system check t...

Страница 41: ...ccessory devices that are connected to the Accessory Port see section 4 4 6 Accessory Port page 28 The laser is activated by pressing the foot switch Laser light is emitted The laser symbol appears on...

Страница 42: ...ggles Avoid looking directly into the red pilot laser light Connect laser fiber see section 5 2 Connecting Laser Fibers page 37 Check laser fiber see section 5 3 Checking the Laser Fiber Using the Pil...

Страница 43: ...location Clean and disinfect the outer surfaces of the device with a cloth according to the hygiene regulations Make sure that no liquids can enter the device openings Sprays must not be used under a...

Страница 44: ...ly used program The laser starts with the stored program parameters Program modifications that were not saved are lost after a restart Some programs are pre installed when the device is shipped from t...

Страница 45: ...ctivate rotary knob by pressing it and select program by turning the rotary knob The parameters of the selected program are shown on the display For information on adjusting the parameters see section...

Страница 46: ...ay area on the left Forward If the program list is longer than shown in the display this option can be used to scroll down the list BACK Scrolls up in the list of programs At the beginning of the list...

Страница 47: ...ameter of the current program is changed Modified disappears when the program is saved under the same or a new name see section 5 12 7 Saving the Modified Program page 51 The adjustable parameters are...

Страница 48: ...while the foot switch is engaged Continuous rate Continuous rate sends the user a feedback signal when the defined amount of energy per cm is reached An additional brief sound is heard The rate time p...

Страница 49: ...er A brief audio signal is sounded when one centimeter has been treated The black bar visually demonstrates the retraction of the fiber An audio signal is sounded when the bar disappears on the left a...

Страница 50: ...ate Cycle mode A cycle consists of a series of pulses and a pause The pulses are set in the same way as in pulse mode The cycle time is the time during which the laser activates the pulse mode No outp...

Страница 51: ...ng of several pulses at least 2 with pulse pauses Cycle pause 5 ms 10 s Pause between two consecutive cycles 5 12 7 Saving the Modified Program If the current program has been modified modified is dis...

Страница 52: ...selected letter by pressing the rotary knob Use the arrow keys to move the insertion marker forward backward Delete deletes text in left direction Cancel closes the editor without changes Save closes...

Страница 53: ...Yes The program is saved with the new parameters The addition modified disappears BACK or No leads back to the Programs menu without overwriting anything 5 12 8 Deleting Programs Delete always acts on...

Страница 54: ...of pulses The log book entry is one line in the log book A confirmation query is displayed prior to saving the values and resetting the counters Confirm the query with Yes Thereafter the summation pr...

Страница 55: ...ears Save values to logfile Selection Yes a log book entry is created Selection No or BACK work can be continued without resetting of the total values Inactivity The following line appears five minute...

Страница 56: ...ly or automatically together with the start time for a treatment and can be loaded by the user If the list contains more than 14 entries you can use the command Next page down to scroll through it The...

Страница 57: ...14 Pilot Laser Select Pilot laser Pilot brightness The brightness of the pilot laser can be adjusted from 1 100 Pilot flash frequency The pilot laser can be set to either CW continuous wave or to puls...

Страница 58: ...settings Select Setup The Setup menu appears Settings can be adjusted in the following sub menus Language Screen Timeouts Date Time Alerts Service for service technicians with PIN code only Setup Lang...

Страница 59: ...determines the time until inactivity of the rotary knob after its last use Light ring bright timeout 30 s to 6 min light ring dark Setting timeout The modification timeout determines the time for mod...

Страница 60: ...Setup menu The dialog Set date Time appears Turn the rotary knob to select a field Press the rotary knob The selected field will have a blue background and can be modified Adjust the numerical value b...

Страница 61: ...the volume Select Laser activation tone and adjust the volume The laser activation tone has a minimum volume in accordance with IEC 60601 that can be increased if required Setup Service This menu ite...

Страница 62: ...er power Set pulse type Set pulse parameters Make sure laser fiber is clean Connect laser fiber to the laser device Close doors of treatment room Activate warning lamp Put on protective goggles Protec...

Страница 63: ...ry equipment before every surgery Hospital staff Inspection of the laser warning lamp before every surgery Hospital staff Use new sterile articles during every surgery Hospital staff Inspection of the...

Страница 64: ...ive cleaners disinfectants or solvents that could scratch the housing or damage the device in other ways For surface cleaning and surface disinfection use the procedure recommended by your hospital or...

Страница 65: ...wn in the information line of the display item 2 section 5 1 6 Display page 34 Example Connect fiber 1 Information line 9 2 Other Malfunctions If there are any malfunctions that the user cannot fix th...

Страница 66: ...55 04 Focusing handpiece 3 attachments with beam diameters of 0 5 1 1 5 mm 79 600 00 04 Bare Fiber 300 m Laser fiber 300 m 3 m 5 pieces 79 700 30 04 Bare Fiber 400 m Laser fiber 400 m 3 m 5 pieces 79...

Страница 67: ...cle time 20 ms 40 s Cycle pause 5 ms 10 s Single mode Output 1 20 W Pulse time 5 ms 10 s Beam guidance Laser fibers focusing handpiece Laser beam quality Numerical laser aperture 0 22 Laser fiber conn...

Страница 68: ...Environmental conditions for transport and storage Ambient temperature 25 C to 50 C 13 F to 122 F Relative humidity no condensing moisture 10 90 Atmospheric pressure 700 1 060 hPa Environmental condit...

Страница 69: ...the unit duly conforms to safety regulations The results of each check must be documented in the medical device logbook and the proper working condition of the unit confirmed by the person performing...

Страница 70: ...tery Ubatt 2 8 V replace battery if required CR2032 Lithium Error memory Select and retrieve internal memory Event log and record messages Take any required actions Emergency Stop Check of EMERGENCY S...

Страница 71: ...e emission or reduced electromagnetic interference immunity of the device and in faulty operation In case of doubt contact Gebr der Martin Guidance and manufacturer s declaration Electromagnetic emiss...

Страница 72: ...mon mode voltage 1 kV differential mode voltage 2 kV common mode voltage The quality of the supply voltage should be that of a typical commercial or hospital environment Voltage dips short power inter...

Страница 73: ...ty of equipment marked with the following symbol HF radiated disturbances according to IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 3 V m 80 MHz to 2 7 GHz Note These guidedances may not apply in all situati...

Страница 74: ...28 704 787 710 745 780 Pulsea 217 Hz 9 800 960 810 870 930 Pulsea 18 Hz 28 1700 1990 1720 1845 1970 Pulsea 217 Hz 28 2400 2570 2450 Pulsea 217 Hz 28 5100 5800 5240 5500 5785 Pulsea 217 Hz 9 Note A min...

Страница 75: ...he device is low maintenance and does not require any consumables It does not generate any waste products or materials or liquids that must be disposed of Follow the respective instructions for access...

Страница 76: ...rland klsmartin com Gebr der Martin GmbH Co KG Moscow Russia Tel 7 499 792 76 19 russia klsmartin com Gebr der Martin GmbH Co KG Dubai United Arab Emirates Tel 971 4 454 16 55 middleeast klsmartin com...

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