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Moller Medical Docon Seal Instructions For Use Manual

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  • Page 1 All manuals and user guides at all-guides.com ® Docon SealM ® Docon Seal Mobile sealing unit...
  • Page 2 All manuals and user guides at all-guides.com...
  • Page 3 All manuals and user guides at all-guides.com © Möller Medical GmbH. All rights reserved. No part of this documentation may be reproduced or translated in any way whatsoever without prior written approval from Möller Medical GmbH. The status of the information, specifications and figures in these instructions for use is indicated by the version number on the last page.
  • Page 4 All manuals and user guides at all-guides.com Page 4 of 68...

  • Page 5: Table Of Contents

    Operator's obligation to exercise diligence ......14 Non-product-related additional equipment ......17 Intended use ..............18 Proper use – intended purpose Docon Seal M ...... 18 Proper use – intended purpose Docon Seal ....18 2.1.1 Combination with other products ........... 18 Essential performance features ..........
  • Page 6 BNC seal handle connection ........22 3.5.2 Charger socket Docon SealM (Figure 2, b) ....22 3.5.3 Mains connection Docon Seal (Figure 3, c)....22 Seal handle ................23 Welding electrodes ..............23 Lever ..................23 Docon Seal Handle ..............24 3.10 BNC connecting cable ............
  • Page 7 Commissioning the Docon Seal ..........30 4.4.1 Connecting and commissioning the Docon Seal..31 Overview of button signal statuses ........31 Suitable operating environments Docon Seal / SealM... 32 Application and operation ..........33 The sealing process ............... 33 5.1.1 Overview of signal statuses on Docon Seal Handle .................34...
  • Page 8 Disposal.................. 48 Appendix ................49 Technical data ................ 49 Electromagnetic emissions............. 52 9.2.1 Docon SealM .............. 53 9.2.2 Docon Seal ..............54 Electromagnetic immunity ............54 9.3.1 Docon SealM .............. 55 9.3.2 Docon Seal ..............58 Recommended separation distances ........62 9.4.1...
  • Page 9 All manuals and user guides at all-guides.com IMPORTANT READ CAREFULLY PRIOR TO USE KEEP IT FOR LATER REFERENCE Page 9 of 68...

  • Page 10: General Safety Instructions

    Information 1.1.2 Symbols on the device Caution, hot surface Docon Seal Handle: Tissue burns can result due to incor- rect use or if the electrodes on the seal handle come into direct contact with tissue. Serial number Lithium ion battery...

  • Page 11: Symbols On The Retail Packaging

    All manuals and user guides at all-guides.com Docon SealM Docon Seal General Safety Instructions Return and disposal as per the WEEE Directive Refer to instruction manual/booklet Class II equipment Conform ANSI/AAMI ES 60601-1 CAN/CSA 22.2 No. 60601-1-08 Alternating current The rating plate is located on the back of the device.
  • Page 12 All manuals and user guides at all-guides.com Docon SealM Docon Seal General Safety Instructions Keep dry Limitation Temperature limitation Manufacturer Fragile, handle with care Attention: Under US Federal law, this device may be only sold to a physician or ordered by a physician.

  • Page 13: Explanation Of The Format Conventions Employed

    All manuals and user guides at all-guides.com Docon SealM Docon Seal General Safety Instructions Explanation of the format conventions employed In these instructions for use, different fonts are used to improve orientation Font Bold Buttons in instructions. Device options, buttons and references to chapter and Italics sections in the body text.

  • Page 14: Operator's Obligation To Exercise Diligence

    The user must not touch one or several device connections and the donor at the same time! The Docon Seal Handle may be used in the vicinity of the donor. While the Docon SealM is being charged on the power unit, no sealing processes are permitted.
  • Page 15 All manuals and user guides at all-guides.com Docon SealM Docon Seal General Safety Instructions Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or donor is established.
  • Page 16 Do not expose the Docon Seal series devices to excessive heat or fire. Do not subject the Docon Seal series devices to major im- pacts. If excessive heat, fumes or smoke are seen, immediately dis- connect the Docon Seal series devices from the power sup- ply.

  • Page 17: Non-Product-Related Additional Equipment

    All manuals and user guides at all-guides.com Docon SealM Docon Seal General Safety Instructions Non-product-related additional equipment Additional equipment which is connected to the analogue and digital device interfaces must demonstrably satisfy the relevant EN specifications (e.g. EN 60950 for data processing devices and EN 60601-1 for electromedical devices).

  • Page 18: Intended Use

    Proper use – intended purpose Docon Seal 2.1.1 The Docon Seal is a medical device and is used for sealing the tubes dur- ing blood donation, plasmapheresis or when processing and storing blood bags and to facilitate simple disconnection. The device can also be used to seal tubes attached to donors.

  • Page 19: Product Description

    Unit base Figure 1: Docon SealM Docon SealM, Docon Seal The Docon Seal series devices supply the required HF energy through the BNC connection cable to the Docon Seal Handle. Up to 150 successive sealing processes can be carried out.

  • Page 20: Integrated Battery Pack (Docon Seal M Only)

    On/Off button and status display The Docon Seal series devices are switched on and off using the button on the front panel. This status display provides you with information about the operational and charge state of the devices.

  • Page 21: Protective Caps

    All manuals and user guides at all-guides.com Docon SealM Docon Seal Product description Protective caps The rubber-like protective caps fitted to front and back protect the devices as well as the BNC seal handle connection against any impacts. Connection options...

  • Page 22: Bnc Seal Handle Connection

    3.5.3 Mains connection Docon Seal (Figure 3, c) The Docon Seal is connected to the mains via the mains connection socket (Figure 3, c ) using the original mains connection cable. Page 22 of 68...

  • Page 23: Seal Handle

    Figure 4: (Docon Seal Handle) Seal handle The Docon Seal Handle is an automated sealing unit used to seal PVC tubes, particularly the blood removal tube directly attached to the donor. This ensures greater safety when sealing the tube.

  • Page 24: Docon Seal Handle

    33). 3.10 BNC connecting cable The BNC connecting cable links the Docon Seal Handle to the Docon SealM and transmits HF energy. The seal handle complies with the electrical safety require- ments of a type B applied part as per EN 60601.

  • Page 25: 3.11 Accessories

    All manuals and user guides at all-guides.com Docon SealM Docon Seal Product description Additional equipment which is connected to the analogue and digital device interfaces must demonstrably satisfy the rele- vant EN specifications (e.g. EN 60950 for data processing de- vices and EN 60601 for medical electrical devices).

  • Page 26: 3.11.2 Transport Case

    All manuals and user guides at all-guides.com Docon SealM Docon Seal Product description 3.11.1.1 Overview of charger signal statuses As well as the display on the Docon SealM, the charger has its own signal indicator. This signal display can indicate green and orange statuses. The following table provides you with an overview.

  • Page 27: 3.11.3 Mains Cable

    The device components are safely stored and transported in the transport case. Any adapters not required can remain in the case. 3.11.3 Mains cable Use the country-specific power cable to connect the Docon Seal device to the power supply (power outlet). Use the power cable to power the Docon Seal.

  • Page 28: Setup And Commissioning

    340 mm x 80 mm x 300 mm Unpacking the device and checking the scope of supply The delivery of a device of the Docon Seal series comprises a cardboard box and a transport case. When unpacking ensure that no parts remain in the packaging.

  • Page 29: Commissioning The Docon Sealm

    All manuals and user guides at all-guides.com Docon SealM Docon Seal Setup and commissioning • 1 x Docon SealM or Docon Seal • 1 x Docon Seal Handle • 1 x BNC connecting cable • 1 x charger (Docon Seal M only) •...

  • Page 30: Connecting The Seal Handle

    On/Off switch. Commissioning the Docon Seal Whenever the Docon Seal is handled and used, precise knowledge and compliance with these instructions for use is necessary. These instructions do not replace user training. The device may only be used by specialist staff.

  • Page 31: Connecting And Commissioning The Docon Seal

    Connect the power cable on the back of the housing to the Do- con Seal power socket. Insert the power cable into a socket. Turn on the Docon Seal by pressing the on/off button. The LED of the on/off switch lights green. Further steps as described in Chapters 4.3.2 to 4.3.4.

  • Page 32: Suitable Operating Environments Docon Seal / Sealm

    Docon SealM Docon Seal Setup and commissioning Suitable operating environments Docon Seal / SealM The Docon Seal / SealM is suitable for environments in the following areas: • Home-based health care Department stores, schools, lodgings (places of residence, nursing homes), hotels, guest houses and stationary vehi-...

  • Page 33: Application And Operation

    (see Overview of signal statuses on Docon Seal Handle, page 34). Possible causes: soiled hoses or dampness. In this case, repeat the sealing process on a clean and dry place.

  • Page 34: Overview Of Signal Statuses On Docon Seal Handle

    10 mm between each sealed point. Check the quality of the seals visually and periodically. Storage conditions After use, store the Docon Seal series devices in accordance with the hy- giene regulations. Also note the storage conditions on page 51. Page 34 of 68...

  • Page 35: Battery Care When Storing The Docon Sealm

    LED lights up orange, continue charging the unit. Energy-saving mode The Docon Seal / Docon SealM features an energy-saving mode that switches the device off automatically 45 minutes after the last welding op- eration. This energy-saving mode is activated as standard upon delivery.
  • Page 36 Remove the charger from the Docon SealM (Docon SealM only). Then press the On/Off button for at least 7 seconds. After this time, the Docon Seal / Docon SealM device switches to the con- figuration menu where you can switch from or to the energy-sav- ing mode.
  • Page 37 3 to 5 after restarting the device. When the Docon Seal / Docon SealM device is in the con- figuration menu, it is not possible to perform welding op- erations.

  • Page 38: Remedying Of Errors

    Remedying of errors A number of errors are listed in this chapter which could occur in connec- tion with the Docon Seal series devices. Several possible solutions are given for each error. The suggestions should be performed in the order given until the error is remedied. The devices must always be turned off when connecting and disconnecting plug connections.
  • Page 39 • Make sure that the device is con- nected to the mains (Docon Seal only). Error due to moisture in the Remove all plugs from the device and the plug connection.

  • Page 40: Service

    Docon SealM Docon Seal Service Service The Docon Seal series devices must not be opened by users. Service measures may only be performed by ser- vice teams who have received appropriate training from the manufacturer. Only send cleaned and disinfected devices to the service team.
  • Page 41 All manuals and user guides at all-guides.com Docon SealM Docon Seal Service Hersteller: Möller Medical GmbH Wasserkuppenstr. 29-31 36043 Fulda, Germany Tel.: +49 (0) 661 / 9 41 95-0 Fax: +49 (0) 661 / 9 41 95-850 http://www.moeller-medical.com e-mail: info@moeller-medical.com Service Tel.: +49 (0) 661 / 9 41 95-108...

  • Page 42: Care

    To rule out any risk to the user, pull all connecting cables out of the device before cleaning. Sterilisation methods such as autoclaving and ethylene oxide sterilisation render the devices of the Docon Seal series unusable. Do not use sharp objects for cleaning.

  • Page 43: Cleaning The Docon Seal Handle

    Cleaning the Docon Seal Handle To rule out any risk to the user, pull the connecting cable out of the Docon Seal Handle before cleaning. Sterilisation methods such as autoclaving and ethylene ox- ide sterilisation render the Docon Seal Handle unusable.
  • Page 44 All manuals and user guides at all-guides.com Docon SealM Docon Seal Care Plunger pins Figure 7 Figure 8 Plunger pins Figure 9 Figure 10 Press the lever as described in Figure 7 against the handpiece until the two electrodes in the handle head come into contact.
  • Page 45 All manuals and user guides at all-guides.com Docon SealM Docon Seal Care The round handpiece and electrodes should be cleaned with a lint-free cloth. The removed lever with electrode can be washed under run- ning water. Dry all parts carefully. Ensure that the electrodes are com- pletely dry to avoid spark discharge.

  • Page 46: Maintenance

    Only use the Do- con SealM/Docon Seal if the devices are functioning safely and/or are safe to operate. Otherwise, they must be repaired immediately by the service team.
  • Page 47 Inside this case. The devices are protected from external damage. If a device of the Docon Seal series is sent to the service team, it must be packed in its original packaging as this provides the device with the best possible protection from external damage.

  • Page 48: Disposal

    - 20 °C 30 minutes 50 °C Disposal Docon Seal series devices and accessories These devices include materials which must be disposed of in an environmentally friendly manner. The European Di- rective 2012/19/EU on waste electrical and electronic equip- ment (WEEE2) applies to this device. This device thus bears the symbol with a crossed-out bin on the rating plate.

  • Page 49: Appendix

    50-60 Hz Current consumption: 0.6 A Input 25.2 V DC, 2 A Protection class: Type of protection: IP 20 Electrical connection of Docon Seal Voltage 100 - 240 VAC (alternating cur- rent) Frequency: 50 - 60 Hz Current consumption: 1.7-0.71 A...
  • Page 50 All manuals and user guides at all-guides.com Docon SealM Docon Seal Appendix Sealing PVC tube specification: 4.0 - 6.0 mm external Ø; 0.75 mm wall thickness Filler media: Air / 0.9% NaCl solution / whole blood / blood components Sealing times:...
  • Page 51 All manuals and user guides at all-guides.com Docon SealM Docon Seal Appendix Transport and storage information Temperature: -20°C to +50°C Humidity: less than 90% relative humidity Weight with packaging: 2400g Width x height x depth Packaging dimensions: 340 mm x 80 mm x 300 mm 700 –...

  • Page 52: Electromagnetic Emissions

    Docon Seal series. When used in the intended manner, the Docon Seal series devices use HF energy to seal hoses at a frequency of 40.66-40.70 MHz. Due to this spec- ified HF energy, the devices of the Docon Seal series can interfere with adjacent devices.

  • Page 53: Docon Sealm

    All manuals and user guides at all-guides.com Docon SealM Docon Seal Appendix 9.2.1 Docon SealM Electromagnetic environ- Measurement of Compliance ment - guidelines electromagnetic in- terference RF electromagnetic Group 2 The Docon SealM must emit interference acc. to electromagnetic energy to...

  • Page 54: Docon Seal

    IEC 61000-3-3 Electromagnetic immunity The Docon Seal series devices are intended for use in the electromagnetic environment specified below. The customer or operator of these devices should ensure that they are operated in an environment such as this.

  • Page 55: Docon Sealm

    All manuals and user guides at all-guides.com Docon SealM Docon Seal Appendix 9.3.1 Docon SealM Electromagnetic en- IEC 60601 - test- Compliance vironment - guide- Immunity ing level level lines test Floors should be ±8 kV contact ±8 kV contact...
  • Page 56 61000-4-3 60601-1-2 inches) from the parts and ca- Ed.4 Ed.4 bles of the Docon Seal indi- cated by the manufacturer. Non-observance may result in a reduction of the device's performance. NOTE 1: At 80 MHz and 800 MHz the higher frequency range applies.
  • Page 57 All manuals and user guides at all-guides.com Docon SealM Docon Seal Appendix Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. The following measurements were not performed because the scope of delivery included an approved charger that has already passed these tests: •...

  • Page 58: Docon Seal

    All manuals and user guides at all-guides.com Docon SealM Docon Seal Appendix 9.3.2 Docon Seal Electromagnetic environ- IEC 60601- Compliance ment - guidelines Immunity test test level level ±8 kV con- ±8 kV contact tact dis- discharge Floors should be wood, con-...
  • Page 59 All manuals and user guides at all-guides.com Docon SealM Docon Seal Appendix Electromagnetic environ- IEC 60601- Compliance ment - guidelines Immunity test test level level on power supply (60% dip in (60% dip in U the user of the device re-...
  • Page 60 RF transmitters, an electro- magnetic site survey should be considered. If the measured field strength in the location in which the Docon Seal is used exceeds the applicable RF compliance Page 60 of 68...
  • Page 61 Docon SealM Docon Seal Appendix level above, the Docon Seal should be observed to verify normal operation. If ab- normal performance is observed, additional measures may be necessary, such as reorienting or relocating the Docon Seal. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

  • Page 62: Recommended Separation Distances

    Never operate the Docon Seal series devices immediately beside or in conjunction with other devices. If operation in the proximity of or stacked with other equipment cannot be avoided, monitor the Docon Seal series devices to verify specified normal operation. 9.4.1 Docon SealM See Chapter 9.3.1...
  • Page 63 Docon SealM power adapter, US 93005986 Docon SealM power adapter, AU 93005989 Instructions for use, EN 9306028 Docon SealM / Docon Seal Docon Seal item numbers and accessories Docon Seal 00003900 Docon Seal Handle 92013574 BNC connecting cable, length 1.8 m 93005638...
  • Page 64 Instructions for Use 9306028 Docon SealM / Docon Seal Do not operate the Docon Seal Handle accessories or the BNC connecting cable with devices or systems other than those of the Docon Seal series as this would increase emission levels or could even impair the interference re- sistance of the other devices and systems.
  • Page 65 All manuals and user guides at all-guides.com...
  • Page 66 All manuals and user guides at all-guides.com...
  • Page 67 All manuals and user guides at all-guides.com...
  • Page 68 All manuals and user guides at all-guides.com Revision status 2021-01 H Software version 0086.02.02 Order number for instructions for use REF 93006028 Möller Medical GmbH Wasserkuppenstraße 29-31 36043 Fulda, Germany Tel. +49 (0) 661 / 94 19 5 – 0 Fax +49 (0) 661 / 94 19 5 –...

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