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Product description

Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR

Item

Order no.

Flexible HD video cystoscope

11272VHU

Video bronchoscope

11900BP

Video bronchoscope HD

11910T

Video bronchoscope HD

11910D

Video bronchoscope

11910P

Video bronchoscope

11910S

Video choledochoscope

11292VP

Video choledochoscope

11292VPU

Video choledochoscope

11292VS

Video choledochoscope

11292VSU

Veterinary videoendoscope

60278VS

Veterinary videoendoscope

60278VSU

Video Mediastinoscope

10973HD

C-Line connection

Item

Order no.

C-MAC S Imager

8403XS

C-MAC S Imager

8403XSI

C-MAC S Pediatric Imager

8403XSP

C-MAC Video laryngoscope MAC #0

8403EXC

C-MAC Video Laryngoscope MAC #2

8403KXC

C-MAC Video Laryngoscope MAC #3

8403AX

C-MAC Video laryngoscope MAC #3

8403AXC

C-MAC Video Laryngoscope MAC #4

8403BX

C-MAC Video laryngoscope MAC #4

8403BXC

C-MAC Video laryngoscope D-BLADE

8403HX

C-MAC Video laryngoscope D-BLADE, Ped.

8403HXP

C-MAC Video Laryngoscope MIL #0

8403DXC

C-MAC Video Laryngoscope MIL #1

8403GXC

C-MAC Video Laryngoscope MIL #2

8403MXC

Flex. Intubation Videoscope

11301ABX

Flex. Intubation Videoscope

11302BDX

Flex. Intubation Videoscope

11303BNX

Flex. Intubation Videoscope

11304BCX

C-MAC VS

10331BX

CMOS Video Rhino-Laryngoscope

11102CM

Содержание TELE PACK +

Страница 1: ...Instructions for use TELE PACK 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: ...l current 10 3 6 Electromagnetic interference 10 3 7 High light intensity 10 3 8 Hot components 10 3 9 Failure of products 10 3 10 Observing ambient conditions 11 3 11 Risk of explosion and fire 11 3...

Страница 4: ...ngs 38 6 11 3 Worklist mode 38 6 11 4 Worklist settings 39 6 11 5 Network dialog 40 6 11 6 Local settings 41 7 Maintenance servicing repairs and disposal 42 7 1 Maintaining the product 42 7 1 1 Mainte...

Страница 5: ...Table of contents Instructions for use TELE PACK CQH848_EN_V2 0_08 2022_IFU_CE MDR 5 10 1 Troubleshooting 51 11 Overview of mitigating warnings 52 12 Subsidiaries 53...

Страница 6: ...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 7: ...otes in the instructions for use must be observed The warnings use the following levels of danger WARNING WARNING Designates a possible imminent risk If this is not avoided it could lead to death or s...

Страница 8: ...c and therapeutic procedures that in order to be performed successfully require the energy materials parameters provided by the applicable device as per the Technical data section of the instruction m...

Страница 9: ...ing instructions before initial use and every subsequent use 3 3 Correct handling and product testing If the product is not handled correctly patients users and third parties may be injured Only perso...

Страница 10: ...6 Electromagnetic interference Medical electrical devices are subject to special precautions regarding electromagnetic compatibility If other devices e g MRT CT diathermy electrocautery or RFID emit...

Страница 11: ...parties When using explosive narcotic gases Operate the product outside of the hazard zone Do not use the product in the presence of flammable anesthetics The product must not be operated in oxygenat...

Страница 12: ...nnection 2 X Line 2 USB 2 0 2x 6 Lateral connection area 3 Connection for stroboscopy microphone 7 Light connection 4 Camera connection 1 C Line 8 ON OFF button 1 2 3 4 5 6 7 8 9 10 11 12 13 TELE PACK...

Страница 13: ...S HX P TH111 IMAGE1 S D1 TH115 IMAGE1 S D1 TH116 C Line connection Article Order no H1 Camera head TH130 4 2 2 Videoendoscopes X Line connection Item Order no CCD Video Rhino Laryngoscope 11101VP CCD...

Страница 14: ...Order no C MAC S Imager 8403XS C MAC S Imager 8403XSI C MAC S Pediatric Imager 8403XSP C MAC Video laryngoscope MAC 0 8403EXC C MAC Video Laryngoscope MAC 2 8403KXC C MAC Video Laryngoscope MAC 3 840...

Страница 15: ...roscope US only 11272VUE R Video uretero renoscope FLEX XC1 091271 01 Video uretero renoscope FLEX XC1 091279 01 4 3 Technical data Description Value Power supply AC 100 240 V Operating frequency 50 6...

Страница 16: ...r languages PostScript 4 4 Symbols employed 4 4 1 Symbols on the packaging Symbol Meaning Manufacturer Date of manufacture Medical device Article no Serial number Number of products in the product pac...

Страница 17: ...A code number after the CE mark indicates the responsible notified body The EU directives relevant to the product can be found in the EU Declaration of Conformity which can be requested from KARL STOR...

Страница 18: ...vice to sale by or on the order of a physician Separate collection of electrical and electronic devices Do not dispose of in household refuse Prevention of pollution by electronic devices CE marking W...

Страница 19: ...he digital fiberscope filter anti moir anti grid filter can be set to two levels A B These filters are able to reduce interfering artifacts such as the moir effect and display of the fiberscope grid I...

Страница 20: ...s Function space Selects various camera functions and changes the product settings Setup menu Changes general product settings Display language Selects the language for the user interface Keyboard lan...

Страница 21: ...be configured In Worklist mode patient data can be retrieved from the worklist server se lected and then stored on the worklist server again Software update Updates the software of the product and of...

Страница 22: ...Meaning Video viewing Shows a recorded video The video does not correspond to the live image Network connection active Network connection disconnected Camera Footswitch Printer USB storage Internal st...

Страница 23: ...aces the selected function with a different function Moves the selected function downward in the Quick menu 4 5 Ambient conditions Storage and transport conditions Temperature 18 C 60 C 0 4 F 140 F Re...

Страница 24: ...he product to fail and start a fire Users patients and third parties may be injured Remove any blockages in the air inlets and outlets when setting up the product CAUTION Breakable glass Risk of injur...

Страница 25: ...he product 1 Connect the potential equalization cable 2 Connect the potential equalization cable to the outlet in the treatment room 3 Connect the power cord Push the power plug fully into the power s...

Страница 26: ...CQH848_EN_V2 0_08 2022_IFU_CE MDR 26 5 4 Connecting external devices 1 Connect the required peripheral devices to the USB interfaces 2 Connect the camera head Push the connector fully into the respec...

Страница 27: ...rs and third parties Switch off the light source before changing the light cable Allow the product to cool down before changing the light cable 1 Insert the light cable into the light connection until...

Страница 28: ...be placed in 2 positions to ensure proper function and to stow the holder for transport in case of mobile use 5 7 Functional test 1 Check the product and the camera head or videoendoscope for external...

Страница 29: ...ng programmed functions and for menu control Scroll down Scrolls down the menus or options Scroll up Scrolls up the menus or options Menu selection Access to the Quick menu A highlighted option is act...

Страница 30: ...operated using the camera head buttons or the keyboard the Quick menu can be accessed by pressing ENTER on the keyboard or the Menu button on the camera head or videoendoscope The configuration of the...

Страница 31: ...configuration menu is divided into 3 columns The functions can be moved replaced added or removed Up to 8 functions can be added in total The configuration is saved by restarting the product 1 2 3 1 Q...

Страница 32: ...tton assignment is fixed on the videoendoscope If two camera heads videoendoscopes are used it must be ensured that the correct source was selected for the application concerned 6 6 2 Footswitch The f...

Страница 33: ...l appear 4 Release the footswitch to close stroboscopy mode and return to steady light mode 5 Press the stroboscopy footswitch twice in quick succession to start or stop the video recording The freeze...

Страница 34: ...videos 6 9 Access and security concept There are two options for protecting the product and the sensitive areas of the menu from access by unauthorized parties Access via a password or via user accoun...

Страница 35: ...ividually definable period of inactivity has expired Once the role based access system has been activated a further menu item with the name Login appears in the main screen next to the information are...

Страница 36: ...default The Patient Data Privacy menu is divided into 3 areas Patient handling Labeling Export mode 6 10 1 Patient handling Worklist setup The worklist setup specifies whether patient data is allowed...

Страница 37: ...d data at a user defined storage location The data can be stored on an FTP server or on a worklist server The data generated are temporarily stored in the internal memory with encrypted assignment and...

Страница 38: ...name of the FTP server Port The port number used to reach the FTP server User If the FTP server requires access the access data will need to be stored Password Timeout Maximum period of time during wh...

Страница 39: ...er is to be used as a user defined storage location save the configuration for the server in the Worklist tab 2 Configure the FTP FileShare tab and enter the required data 3 Press the Connect button t...

Страница 40: ...Network dialog The network dialog can be called up via the Network settings Setup menu The settings can be changed and the user defined storage location can be specified in the network dialog The netw...

Страница 41: ...configuration is defined on the LAN tab The configuration is performed automatically via DHCP or manually Press the Connect button to test the set configuration if the data is entered manually The tes...

Страница 42: ...ational accident prevention regulations and testing intervals for medical devices for this device safety checks must be performed as repeat inspections according to IEC 62353 and recorded by a qualifi...

Страница 43: ...ted products 7 4 Disposing of the product The product meets the requirements of the Directive on Waste Electrical and Electronic Equipment WEEE Within the scope of application of this directive KARL S...

Страница 44: ...ices length 180 cm 20221070 Power cord length 300 cm 400F DVI connecting cable length 200 cm 20040086 DVI connecting cable length 300 cm 20040089 Power cord US version 200 cm 400B USB silicone keyboar...

Страница 45: ...Electromagnetic interferences Malfunction Use of this equipment adjacent to or stacked with other equipment could result in improper operation Avoid this situation If such use is necessary Ensure that...

Страница 46: ...con ductor ground The power supply quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations acc to IEC 61000 4 11 Voltage dip Dip...

Страница 47: ...elds from HF wireless communications equipment Test frequency 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 Hz...

Страница 48: ...f the transmitter in watts W according to the infor mation provided by the transmitter manufacturer and d is the recommended sepa ration distance in meters m Field strengths from fixed HF transmitters...

Страница 49: ...ments Compliance Electromagnetic environment guidelines RF emissions acc to CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are n...

Страница 50: ...listed in the table above the recommended separation distance d in meters m can be estimated using the equation from the respective col umn whereby P is the maximum rated power of the transmitter in...

Страница 51: ...mperature above 90 C Lamp is switching off after a few minutes Lamp overheated Allow the lamp to cool down to below 80 C LED temperature above 100 C Lamp overheated Turn off the lamp and let it cool d...

Страница 52: ...M including cables specified by the man ufacturer Otherwise degradation of the performance of this equipment could result WARNING Use of this equipment adjacent to or stacked with other equipment shou...

Страница 53: ...irio St 94 LT9300 Vilnius Lithuania Phone 370 5 272 0448 Mobile 370 685 67 000 E mail info lt lv karlstorz com KARL STORZ Endoskopi Danmark A S Skovlytoften 33 2840 Holte Denmark Phone 45 45162600 Fax...

Страница 54: ...td Shanghai Branch Room 701A Building 5 Room 501 Building 7 No 3000 Longdong Avenue Pilot Free Trade Zone 201203 Shanghai People s Republic of China Phone 86 21 60339888 Fax 86 21 60339808 E mail info...

Страница 55: ...Subsidiaries Instructions for use TELE PACK CQH848_EN_V2 0_08 2022_IFU_CE MDR 55...

Страница 56: ...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 CQH848 EN V2 0 08 2022 IF...

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