Moller Medical Docon SealM Instructions For Use Manual
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Moller Medical Docon SealM Instructions For Use Manual

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Summary of Contents for Moller Medical Docon SealM

  • Page 1 ® Docon SealM ® Docon Seal Mobile sealing unit...
  • Page 3 © 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 Page 4 of 68...

  • Page 5: Table Of Contents

    Proper use – intended purpose Docon Seal ....18 2.1.1 Combination with other products ........... 18 Essential performance features ..........18 Product description ............19 Docon SealM, Docon Seal ............. 19 3.1.1 Integrated battery pack (Docon Seal M only) ....20 On/Off button and status display......... 20...
  • Page 6 Protective caps ............... 21 Connection options..............21 3.5.1 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 ..................
  • Page 7 The sealing process ............... 33 5.1.1 Overview of signal statuses on Docon Seal Handle .................34 Storage conditions ..............34 Battery care when storing the Docon SealM......35 Energy-saving mode .............. 35 Remedying of errors ............38 Service ................40 Care................... 42 Cleaning and disinfection the devices........
  • Page 8 Service documents ............. 46 Transport ................46 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 ........
  • Page 9 IMPORTANT READ CAREFULLY PRIOR TO USE KEEP IT FOR LATER REFERENCE Page 9 of 68...

  • Page 10: General Safety Instructions

    Docon SealM Docon Seal General Safety Instructions General Safety Instructions Explanation of the safety symbols employed In these instructions for use, important information is indicated visually. This information is essential for avoiding risks to the donor and operating personnel and avoiding damage to and malfunctioning of the device.

  • Page 11: Symbols On The Retail Packaging

    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 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. Further information on the symbols used can be found on our homepage: www.moeller-medical.com/glossary-symbols.

  • Page 13: Explanation Of The Format Conventions Employed

    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 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. The device itself prevents this from happening. Page 14 of 68...
  • Page 15 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 When cleaning, ensure that no cleaning agent runs into the connector sockets. Remove the charger from the Docon SealM or the power cord from the Docon Seal before cleaning. Replace connecting cables of all kinds even if they are only slightly damaged;...

  • Page 17: Non-Product-Related Additional Equipment

    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

    Intended use Proper use – intended purpose Docon Seal M The Docon SealM is a medical device and is used for sealing the hoses during blood donation or when processing and storing blood bags and to facilitate simple disconnection. The device is transportable and can also be used to seal hoses attached to donors.

  • Page 19: Product Description

    BNC - seal handle connection (Docon Seal Handle) 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)

    2000 sealing processes. The battery does not reach full capacity until after a few charge cycles. If not in use for extended periods, the Docon SealM must be stored in a charged state. See Storage conditions After use, store the Docon Seal series devices in accord- ance with the hygiene regulations.

  • Page 21: 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 The following connection options are available with the Docon SealM: Figure 2: Connection options on the Docon SealM a: BNC seal handle connection...

  • Page 22: Bnc Seal Handle Connection

    The BNC socket (Figure 2 and Figure 3, a) serves to connect the BNC cable and the associated original Docon Seal Handle. 3.5.2 Charger socket Docon SealM (Figure 2, b) The internal battery is charged via the charger socket (Figure 2b) with the help of the relevant original charger device.

  • Page 23: Seal Handle

    Docon SealM Docon Seal Product description BNC – connecting cable Sealing indicator (Docon Seal Handle Lever Welding electrodes 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.

  • Page 24: Docon Seal Handle

    Docon SealM Docon Seal Product description Docon Seal Handle The sealing process is indicated by an LED on the seal handle (see Appli- cation and operation on page 33). 3.10 BNC connecting cable The BNC connecting cable links the Docon Seal Handle to the Docon SealM and transmits HF energy.

  • Page 25: 3.11 Accessories

    3.11.1 Charger and adapter Figure 5: Charger Use the adapter to adapt the charger to the country-specific power supply (socket). Use the charger to charge the Docon SealM battery (see Con- necting and charging the Docon SealM battery , page 29).

  • Page 26: 3.11.2 Transport Case

    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

    Docon SealM Docon Seal Product description 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).

  • Page 28: Setup And Commissioning

    Only send the devices in its original transport case and its associated packaging to prevent transport damage. The scope of delivery of the standard versions of Docon SealM and Do- con Seal include the following: Page 28 of 68...

  • Page 29: Commissioning The Docon Sealm

    Plug the charger connector on the back of the housing into the Docon SealM. Plug the charger into a socket. Note the voltage values stated on the charger. The internal battery on the Docon SealM is now charging and the LED on the On/Off switch flashes orange. Page 29 of 68...

  • Page 30: Connecting The Seal Handle

    Connect the other end of the cable to the Docon SealM and, once again, secure by turning it clockwise. 4.3.3 Switching on To switch on the Docon SealM, press the On/Off switch on the front of the device. 4.3.4 Switching off After completing the sealing processes, turn off the Docon SealM by press- ing the On/Off switch.

  • Page 31: Connecting And Commissioning The Docon Seal

    Further steps as described in Chapters 4.3.2 to 4.3.4. Overview of button signal statuses Colour Status Ready for operation Green Remaining capacity of battery 10- Green Flashing (Docon SealM only) Residual capacity of battery <10% Orange Flashing (Docon SealM only) Error status or BATTERY empty Orange Charging Orange...

  • 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

    Docon SealM Docon Seal Application and operation Application and operation The sealing process Place the tube to be sealed in the recess on the seal handle. Press the seal handle lever as far as it will go. The LED on the seal handle lights up and sealing starts automatically.

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

    Docon SealM Docon Seal Application and operation 5.1.1 Overview of signal statuses on Docon Seal Handle Colour Status Sealing Orange Sealing complete Orange Flashing Sealing defective Orange Flashing rapidly Short circuit detected Orange Flashing rapidly Ready for sealing Orange Switched off Make sure that the surface of the tube, at the point where the seal is to be made, is dry and free of dirt.

  • 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 Docon Seal Application and operation It is only possible to switch between energy-saving mode and continuous operation with a fully charged battery (Docon SealM only) and without a charger connected (Docon SealM only). Proceed as follows: Before switching modes, charge the device until the status LED on the device and the LED on the charger are lit up green (Docon SealM only).
  • 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

    Should these suggestions not help to remedy the error, the defect must be resolved by the Möller Medical GmbH service team. Solution Errors • The Docon SealM cannot be Charge the Docon SealM. turned on. • The Docon Seal cannot be Check the correct plug connection of turned on.
  • Page 39 Make sure that the battery is fully will not switch on or off charged (Docon SealM). • Make sure that the Docon SealM is disconnected from the charger once the battery is fully charged. • Make sure that the device is con- nected to the mains (Docon Seal only).

  • 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 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 Fax: +49 (0) 661 / 9 41 95-850 e-mail:service@moeller-medical.com...

  • Page 42: Care

    Docon SealM Docon Seal Care Care Cleaning and disinfection the devices 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.

  • Page 43: Cleaning The Docon Seal Handle

    Docon SealM Docon Seal Care 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 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. Press the plunger pins in on both sides until an audible "click" is heard (see Figure 8 and Figure 9).
  • Page 45 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

    Docon SealM Docon Seal Care Pull the lever with the electrode on the handpiece until both pins emit an audible "click" (see Figure 13 and Figure 14). Press the lever twice and make sure that the electrodes move uni- formly and are not loose.
  • Page 47 Docon SealM Docon Seal Care on page 49). For daily transport, the scope of delivery includes a transport case. 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

    Docon SealM Docon Seal Care Warm-up / cool-down phase without case Transport temperature 90 minutes - 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.

  • Page 49: Appendix

    Length x width x height and Docon Seal 185 mm x 94 mm x 61 mm Weight [kg]: 900 g (excluding the seal handle) Electrical connection charger / Docon SealM input Voltage: 100-240 V AC Frequency: 50-60 Hz Current consumption: 0.6 A...
  • Page 50 Docon Seal Successive sealing procedures 300 (at 25 °C) For ambient temperature 150 (at +10 °C to +35 °C) 120 (at +35 °C to +40 °C) Docon SealM battery: Type: Lithium ion battery Voltage: 22.2 V Capacity: 2250 mAh Energy: 49.95 Wh...
  • Page 51 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 – 1050 hPa...

  • Page 52: Electromagnetic Emissions

    This radiated emissions level can interfere with devices located near the Docon Seal series devices. If abnormal performance is observed on other adjacent devices, additional measures may be neces- sary, such as reorienting or relocating the Docon SealM. Page 52 of 68...

  • Page 53: Docon Sealm

    Measurement of Compliance ment - guidelines electromagnetic in- terference RF electromagnetic Group 2 The Docon SealM must emit interference acc. to electromagnetic energy to CISPR 11 ensure that it performs its in- tended function. Electronic devices in the vicinity could be influenced.

  • Page 54: Docon Seal

    Docon SealM Docon Seal Appendix 9.2.2 Docon Seal Electromagnetic environ- Measurement of Compliance ment - guidelines electromagnetic in- terference RF electromagnetic Group 2 The Docon Seal must emit interference acc. to electromagnetic energy to CISPR 11 ensure that it performs its in- tended function.

  • Page 55: Docon Sealm

    Notes: U is the AC mains voltage prior to application of the test level. The Docon SealM is intended for use in the electromagnetic environment specified below. The customer or operator should ensure that the Docon SealM is used in an environment such as this.
  • Page 56 RF transmitters, an electro- magnetic site survey should be considered. If the measured field strength in the location in which the Docon SealM is used exceeds the applicable RF compliance level above, the Docon SealM should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Docon SealM.
  • Page 57 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 • Conducted RF acc. to IEC 61000-4-6 The Docon SealM satisfies all test levels in accordance with IEC 60601-1- 2 Edition 4 (table 4 to 9). Page 57 of 68...

  • Page 58: Docon Seal

    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- charge Electrostatic dis- crete or ceramic tile. If floors...
  • Page 59 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- input lines quires continued operation for 5/6...
  • Page 60 Docon SealM Docon Seal Appendix Electromagnetic environment - IEC 60601- Compliance Immunity guidelines test level level test 3 Veff 3 Veff 150 kHz to 150 kHz to 30 MHz 30 MHz Recommended separation dis- tance: Conducted 6 Veff in ISM 6 Veff in ISM RF acc.
  • 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

    See Chapter 9.3.1 9.4.2 Docon Seal See Chapter 9.3.2 Accessories Procurement options for accessories: From Möller Medical GmbH or your direct distributor Docon SealM item numbers and accessories Docon SealM 00003681 Docon SealM (control unit) 92014152 Docon Seal Handle 92013574...
  • Page 63 BNC connecting cable, length 1.8 m 93005638 Docon SealM transport case 93005938 93005948 Docon SealM charger (without power adapter) Docon SealM power adapter, EU 93005981 Docon SealM power adapter, UK 93005985 Docon SealM power adapter, US 93005986 Docon SealM power adapter, AU...
  • Page 64 Docon Seal Appendix 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 68 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 – 850 http://www.moeller-medical.com info@moeller-medical.com...

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