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Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR

17

4.5 Symbols employed

4.5.1 Symbols on the packaging

Symbol

Meaning

Manufacturer

Date of manufacture

Medical device

Article no.

Serial number

Number of products in the product packaging

Unique Device Identifier

Consult the printed or electronic instructions for use

Note for the user to consult the instructions for use for important cau-
tionary information such as warnings and precautions.

Fragile, handle with care

Keep dry

Temperature limit

Humidity limit

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Содержание UNIDRIVE Select

Страница 1: ...Instructions for use UNIDRIVE Select en...

Страница 2: ...illustrations product descriptions and texts are the intellectual property of KARL STORZ SE Co KG Their use and reproduction by third parties require the express approval of KARL STORZ SE Co KG All ri...

Страница 3: ...ts 8 3 5 Risk of explosion and fire 9 3 6 Dangers from electrical current 9 3 7 Damage due to ingress of liquid in electrical components 10 3 8 Electromagnetic interference 10 3 9 Failure of products...

Страница 4: ...uct 42 7 1 1 Maintenance 42 7 2 Changing a fuse 42 7 3 Safety inspection in accordance with IEC 62353 44 7 3 1 Visual inspection 44 7 3 2 Electric measurements 44 7 3 3 Functional test 44 7 4 Repairin...

Страница 5: ...mpatible products are not followed patients users and third parties may be injured or the product may be damaged Read the instructions for use of the compatible products carefully and follow all the s...

Страница 6: ...e imminent risk If this is not avoided it could lead to death or serious injuries CAUTION CAUTION Designates a possible imminent risk If this is not avoided it could lead to minor injuries NOTICE NOTI...

Страница 7: ...nd central cardiovascular system Beyond that there are no contraindications for use of the medical devices directly associated with the medical devices 2 4 Target user populations The medical device m...

Страница 8: ...of the product may work with it Check that the product is suitable for the procedure prior to use Check the correct configuration of the product after every software update Check the product for the f...

Страница 9: ...side of the hazard zone Do not use the product in the presence of flammable anesthetics The product must not be operated in oxygenated environments Only connect or disconnect the power plug to or from...

Страница 10: ...tic compatibility and must be installed and commissioned according to the tables on electromagnetic compatibility If other products e g for MRT CT diathermy electrocautery or RFID emit electromagnetic...

Страница 11: ...orted operated or reprocessed under unsuitable conditions patients users or third parties may be injured and the device can be damaged Observe the ambient conditions listed in the instructions for use...

Страница 12: ...eshooting in the OR is easier since any faults that may occur a motor fault for example are displayed automatically Two motors can be connected simultaneously via two connections e g two drill handpie...

Страница 13: ...is recommended that the suitability of the products for the intended procedure be checked prior to use Please note that the products listed here may not yet be available in all countries due to differ...

Страница 14: ...se 2 x T 4 0 AH 250 V IEC 127 format Power consumption 200 VA Electrical protection class I Applied part type according to IEC 60601 1 BF Degree of protection acc to IEC 60259 IPX1 protection from dri...

Страница 15: ...e Rotation Micro ear burr Minimum speed 2 000 rpm 10 Maximum speed 12 000 rpm 10 Start up maximum speed 12 000 rpm 10 Rotation mode Rotation DrillCut X II shaver Minimum speed 300 rpm 10 Maximum speed...

Страница 16: ...pm 10 Start up maximum speed 35 000 rpm 10 Rotation mode Rotation DrillCut X II Spine Minimum speed 300 rpm 10 Maximum speed 12 000 rpm 10 Start up maximum speed 12 000 rpm 10 Rotation mode Rotation S...

Страница 17: ...ate of manufacture Medical device Article no Serial number Number of products in the product packaging Unique Device Identifier Consult the printed or electronic instructions for use Note for the user...

Страница 18: ...number after the CE mark indicates the responsible notified body The EU directives relevant to the product can be found in the EU Decla ration of Conformity which can be requested from KARL STORZ 4 5...

Страница 19: ...s Separate collection of electrical and electronic devices Do not dispose of in household refuse CE marking With this marking the manufacturer declares the conformity of the prod uct with the applicab...

Страница 20: ...own Increase value Decrease value 4 6 Ambient conditions Storage and transport conditions Temperature 15 C 60 C 5 F 140 F Relative humidity non condensing 5 85 Air pressure 600 1 080 hPa Average life...

Страница 21: ...fire Patients users and third parties may be injured Ensure that there is sufficient air circulation Keep air inlets and outlets free CAUTION Breakable glass Risk of injury The glass of the screen wil...

Страница 22: ...ord Push the power plug fully into the power socket The standby button lights up white 3 Connect the Ethernet cable for combination with ENDOMAT SELECT UP220 4 Connect the footswitch cable to the fron...

Страница 23: ...bles to the motor outputs To do this align the red dot on the cable with the red dot on the relevant socket 6 To avoid damaging the cables pull on the plug when removing the cables 5 4 Putting the pro...

Страница 24: ...e standby button lights up green after 40 to 50 seconds a signal sounds and the following start screen appears If no application instrument or motor is connected the following start screen appears If...

Страница 25: ...on is expanded again 6 If a KARL STORZ pump is not being used close the message The following message appears 7 Put the pump used into operation 8 Change the language see chapter Setting the language...

Страница 26: ...ducts Dispose of disposable products in accordance with the applicable regulations WARNING Expiry date passed Risk of infection Check the expiry date Check the packaging for damage Never use products...

Страница 27: ...lever of the tubing set counterclockwise The following screen appears on the ENDOMAT SELECT 3 Connect the tubing ends with the irrigation bag puncture needle or with the irrigation connector on the in...

Страница 28: ...ed examples are used to illustrate how handpieces are selected Other handpieces can be chosen accordingly 6 1 1 High speed micro motor 1 Connect the motor see chapter Connecting the product p 21 The f...

Страница 29: ...ect the desired burr e g High speed burr 80 k The following screen appears 5 Set the speed see chapter Setting the speed p 33 6 1 2 DrillCut X II 35 1 Connect the motor see chapter Connecting the prod...

Страница 30: ...Application Instructions for use UNIDRIVE Select PCC270_EN_V1 0_02 2022_IFU_CE MDR 30 3 Select the desired handpiece The following screens appear 4 Set the speed see chapter Setting the speed p 33...

Страница 31: ...PCC270_EN_V1 0_02 2022_IFU_CE MDR 31 6 1 3 INTRA motor 1 Connect the motor see chapter Connecting the product p 21 The following screen appears 2 Tap on the Arrow to expand the handpiece selection 3 S...

Страница 32: ...et the speed see chapter Setting the speed p 33 6 1 4 Micro ear burr 1 Connect the motor see chapter Connecting the product p 21 The following screen appears 2 Set the speed see chapter Setting the sp...

Страница 33: ...elect the handpiece e g High speed burr 80k see chapter Selecting the handpiece p 28 The handpiece screen appears with the maximum speed value 2 Tap the speed value The Minus button appears 3 Tap the...

Страница 34: ...rotation 1 Select the handpiece e g High speed burr 80k see chapter Selecting the handpiece p 28 2 The handpiece screen appears 3 Tap on the Forward button to change the direction of rotation 4 Altern...

Страница 35: ...for longer than 2 seconds to switch between the two motor connectors see chapter Operating the footswitch p 36 6 5 Setting the irrigation flow WARNING Insufficient irrigation Risk of injury When rota...

Страница 36: ...2 seconds The irrigation flow starts with the preset value 2 Release the left pedal The irrigation flow stops 3 Press the left pedal briefly The irrigation flow is either increased or reduced dependin...

Страница 37: ...he button 1 for longer than 2 seconds to switch between the two motor connections 6 7 Settings 1 Tap on the Settings button on the top right of the touchscreen The Settings screen appears with the fol...

Страница 38: ...want to use The language is saved 3 Browse back through the screen with the Arrow The Settings screen appears 6 7 3 Setting the brightness and volume 1 In the Settings screen tap on the Further settin...

Страница 39: ...creen tap on the Further settings sub menu The Further settings screen appears 2 Tap on the Event log sub menu The Event log screen appears 3 Tap on the desired line to call up the entry on the event...

Страница 40: ...etting 10 ml min Down The value is reduced by 10 ml min down to the lowest value and starts again with the highest setting 6 7 6 Setting the motor stop behavior 1 In the Settings screen tap on the Sto...

Страница 41: ...Application Instructions for use UNIDRIVE Select PCC270_EN_V1 0_02 2022_IFU_CE MDR 41 6 8 Switching off the product 1 Switch off the product with the stand by button...

Страница 42: ...g maintenance intervals are recommended Interval Activity To be performed by annually Safety test KARL STORZ service techni cians 7 2 Changing a fuse WARNING Undesired current flow Risk of injury Live...

Страница 43: ...22_IFU_CE MDR 43 2 Remove the defective fuse 3 Insert the new fuse Only use fuses with the same fuse ratings see chapter Technical data p 14 4 Introduce the screw inserts into the power fuse holder ag...

Страница 44: ...y mechanical damage 2 Check labels for readability 7 3 2 Electric measurements Limit values for electrical measurements can be found in the current IEC 62353 1 Measure the protective ground resistance...

Страница 45: ...Within the scope of application of this directive KARL STORZ SE Co KG is responsible for the proper disposal of this product 1 The product must be disposed of in accordance with the applicable nationa...

Страница 46: ...cable 150 cm 20010570 Potential equipotential cable 1 m 20010670 Ethernet cable OR1 patch cable CAT6a length 2 0 m UL listed WO10275 Footswitch Article Order no Two pedal footswitch one stage UF201 Tw...

Страница 47: ...angled 80 000 rpm with inte grated irrigation 362680 High speed handpiece 70 mm straight 80 000 rpm with inte grated irrigation 362645 High speed handpiece super long 80 000 rpm 362685 INTRA handpiece...

Страница 48: ...burr 7 0 mm 70 mm 50 000 rpm 340870 High speed standard burr 0 8 mm 70 mm 50 000 rpm 340108 High speed standard burr 1 0 mm 70 mm 50 000 rpm 340110 High speed standard burr 1 4 mm 70 mm 50 000 rpm 34...

Страница 49: ...mond burr rough 4 0 mm 70 mm 80 000 rpm single use product sterile 360340ES High speed standard burr 2 3 mm 70 mm 80 000 rpm sin gle use product sterile 360123ES High speed standard burr 3 1 mm 70 mm...

Страница 50: ...0 mm 125 mm 80 000 rpm sin gle use product sterile 360140M High speed standard burr 5 0 mm 125 mm 80 000 rpm sin gle use product sterile 360150M High speed standard burr 6 0 mm 125 mm 80 000 rpm sin...

Страница 51: ...oduct sterile 360340L High speed diamond burr rough 5 0 mm 150 mm 80 000 rpm single use product sterile 360350L High speed standard burr 3 1 mm 150 mm 80 000 rpm sin gle use product sterile 360131L Hi...

Страница 52: ...burr 0 6 mm reusable sterile 12 000 rpm 460206 Diamond micro ear burr 0 7 mm reusable sterile 12 000 rpm 460207 Diamond micro ear burr 0 8 mm reusable sterile 12 000 rpm 460208 Diamond micro ear burr...

Страница 53: ...4 0 AH 250 V AC IEC 127 format 2027690 Perforator Motor without cable 362641 Perforator connecting cable for connection to the perforator mo tor 362641 362642 High speed micro motor without cable 2036...

Страница 54: ...ection to radio communication service In the rare event of interference to the radio transmission operation the user might need to take mitigation measures such as relocating or re orienting the produ...

Страница 55: ...nd voltage variations acc to IEC 61000 4 11 Voltage dip Dip to 0 for 1 cycle at 0 phase angle Dip to 70 for 25 30 cycles at 0 phase an gle Dropout to 0 for 0 5 cycles 0 45 90 135 180 225 270 and 315 p...

Страница 56: ...ields from HF wireless communications equipment Test fre quency MHz Frequency band MHz Radio service Modulation Immunity test level V m Compliance level V m 385 380 390 TETRA 400 Pulse modula tion 18...

Страница 57: ...nications equip ment should be used no closer to any part of the product including cables than the recommended separation distance calcu lated from the equation applicable to the fre quency of the tra...

Страница 58: ...s and manufacturer s declaration electromagnetic emissions The product is intended for use in such an environment as specified below The customer or user of the device should ensure that it is used in...

Страница 59: ...in the table above the recom mended separation distance d in meters m can be estimated using the equation from the re spective column whereby P is the maximum rated power of the transmitter in watts W...

Страница 60: ...ed Faulty handpiece Connect another handpiece Handpiece blocked or jammed Clean handpiece Tubing set connectors do not fit in the pump Tubing set installed incor rectly Check the connection side upper...

Страница 61: ...TEM including cables specified by the manufacturer Otherwise degradation of the performance of this equip ment could result WARNING Use of this equipment adjacent to or stacked with other equipment sh...

Страница 62: ...KARL STORZ Endoscopy Suomi OY Taivaltie 5 01610 Vantaa Finland Phone 358 0 96824774 Fax 358 0 968247755 E mail asiakaspalvelu karlstorz fi KARL STORZ SE Co KG Representative Office algirio St 94 LT930...

Страница 63: ...lding B 18F Beijing IFC No 8 Jianguomenwai Street Chaoyang District 100022 Beijing People s Republic of China Phone 86 10 5638188 Fax 86 10 5638199 E mail info karlstorz com cn KARL STORZ Endoscopy Sh...

Страница 64: ...RZ SE Co KG Dr Karl Storz Stra e 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone 49 7461 708 0 Fax 49 7461 708 105 E mail info karlstorz com www karlstorz com PCC270 EN V1 0 02 2022 IF...

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