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Docon SealM

Docon Seal

Appendix

Page 61 of 68

The Docon Seal satisfies all test levels in accordance with IEC 60601-1-2
Edition 4 (table 4 to 9).

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.

Содержание Docon Seal

Страница 1: ...Docon SealM Docon Seal Mobile sealing unit Instructions for use en...

Страница 2: ......

Страница 3: ...tion specifications and figures in these instructions for use is indicated by the version number on the last page M ller Medical GmbH reserves the right to make changes in terms of technology func tio...

Страница 4: ...Page 4 of 68...

Страница 5: ...at conventions employed 13 1 3 Manufacturer s responsibility 13 1 4 Operator s obligation to exercise diligence 14 1 5 Non product related additional equipment 17 2 Intended use 18 2 1 Proper use inte...

Страница 6: ...e 3 c 22 3 6 Seal handle 23 3 7 Welding electrodes 23 3 8 Lever 23 3 9 Docon Seal Handle 24 3 10 BNC connecting cable 24 3 11 Accessories 25 3 11 1 Charger and adapter 25 3 11 2 Transport case 26 3 11...

Страница 7: ...w of button signal statuses 31 4 6 Suitable operating environments Docon Seal SealM 32 5 Application and operation 33 5 1 The sealing process 33 5 1 1 Overview of signal statuses on Docon Seal Handle...

Страница 8: ...46 8 4 Transport 46 8 5 Disposal 48 9 Appendix 49 9 1 Technical data 49 9 2 Electromagnetic emissions 52 9 2 1 Docon SealM 53 9 2 2 Docon Seal 54 9 3 Electromagnetic immunity 54 9 3 1 Docon SealM 55 9...

Страница 9: ...Page 9 of 68 IMPORTANT READ CAREFULLY PRIOR TO USE KEEP IT FOR LATER REFERENCE...

Страница 10: ...information is essential for avoiding risks to the donor and operating personnel and avoiding damage to and malfunctioning of the device 1 1 1 Symbols in the instructions for use Caution Information 1...

Страница 11: ...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 th...

Страница 12: ...tation 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 symb...

Страница 13: ...ety reliability and suitability for use of the devices if Assembly expansions resetting changes and repairs are performed by individuals authorised by the manufac turer The electrical installation in...

Страница 14: ...knowledge and experience The Docon Seal series devices are subject to special pre cautionary measures with respect to electromagnetic com patibility EMC and must be installed and operated in ac cordan...

Страница 15: ...Safety Instructions Page 15 of 68 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 u...

Страница 16: ...lightly damaged make sure not to roll over cables Keep the cables away from heat sources This prevents the isolation from melting which could cause a fire or an electric shock Do not use force to push...

Страница 17: ...sfy the relevant EN specifications e g EN 60950 for data processing devices and EN 60601 1 for electromedical devices Whoever connects additional devices to the signal input or output part is the syst...

Страница 18: ...cal 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...

Страница 19: ...eal 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 If the temperature of the seal gene...

Страница 20: ...tions on page 51 page 34 Due to its integrated battery pack the device must be disposed of properly Batteries must not be disposed of as domestic waste Physical properties mean that as the battery age...

Страница 21: ...e caps fitted to front and back protect the devices as well as the BNC seal handle connection against any impacts 3 5 Connection options The following connection options are available with the Docon S...

Страница 22: ...n 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 t...

Страница 23: ...lood removal tube directly attached to the donor This ensures greater safety when sealing the tube Various PVC tubes with different diameters and wall thicknesses can be sealed The sealing time is aut...

Страница 24: ...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 Only the original seal handle may be c...

Страница 25: ...ional devices to the signal input or output part is the system configurer and thus responsible for ensuring that the valid version of EN 60601 1 is observed Should you have any queries please contact...

Страница 26: ...dicator This signal display can indicate green and orange statuses The following table provides you with an overview Status Colour LED Operating mode ready for opera tion Green Lit Operating mode char...

Страница 27: ...nts 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...

Страница 28: ...Weight incl packaging 2400g Dimensions of the Docon SealM and Docon Seal with packaging Width x height x depth 340 mm x 80 mm x 300 mm 4 2 Unpacking the device and checking the scope of supply The de...

Страница 29: ...The device may only be used by specialist staff 4 3 1 Connecting and charging the Docon SealM battery Fully charge the Docon SealM before initial commissioning The charge process can take up to 4 5 h...

Страница 30: ...e 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 Switc...

Страница 31: ...on the Docon Seal by pressing the on off button 5 The LED of the on off switch lights green Further steps as described in Chapters 4 3 2 to 4 3 4 4 5 Overview of button signal statuses Status Colour...

Страница 32: ...uses and stationary vehi cles provided that the devices are not connected to the vehi cle s DC power supply Professional healthcare facilities with specific requirements Clinics rooms in A E hospital...

Страница 33: ...ks appear in the welding seam repeat the sealing process 10 mm to the left or right beside the welding seam already created 6 After correctly performing the sealing process disconnect the hose by pull...

Страница 34: ...rface of the tube at the point where the seal is to be made is dry and free of dirt Sealing stops immediately when you release the seal handle lever The tube must not be subjected to mechanical loadin...

Страница 35: ...ntinue charging the unit After not being used for 6 months the battery must be re charged to reach a charge state of at least 65 The state of charge can be read off the display on the charger The LED...

Страница 36: ...e energy sav ing mode This is indicated by a change in the colour of the status LED Depending on which mode is set energy saving or contin uous operation the status LED either flashes orange or is per...

Страница 37: ...on menu it is not possible to perform welding op erations When the Docon Seal Docon SealM device is in contin uous operation it monitors the current charge status of the integrated battery Docon SealM...

Страница 38: ...ns Should these suggestions not help to remedy the error the defect must be resolved by the M ller Medical GmbH service team Errors Solution The Docon SealM cannot be turned on Charge the Docon SealM...

Страница 39: ...r off Make sure that the battery is fully 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...

Страница 40: ...erformed by ser vice teams who have received appropriate training from the manufacturer Only send cleaned and disinfected devices to the service team When returning a device of the Docon Seal series e...

Страница 41: ...ical 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...

Страница 42: ...he device Lint free soft tissues are to be used for wipe down disin fection and cleaning Clean using a cloth dampened with mild soap solution or 70 isopropane solution After cleaning disinfect the sur...

Страница 43: ...ow into the electronic compo nents of the seal handle Do not use sharp objects for cleaning To guarantee the functionality and safety of the seal handle it must be cleaned regularly You will find a li...

Страница 44: ...the handpiece until the two electrodes in the handle head come into contact 2 Press the plunger pins in on both sides until an audible click is heard see Figure 8 and Figure 9 Use a ballpoint pen or...

Страница 45: ...d spark discharge Assembly of the handpiece and lever with electrode after cleaning Figure 11 Figure 12 Figure 13 Figure 14 1 Place the lever with electrode on the handpiece and ensure that the lever...

Страница 46: ...ety check as per the German Medical Devices Operator Ordinance MPBetreibV must be performed at least every 12 months It ensures that the basic safety and the electromagnetic characteristics of the dev...

Страница 47: ...provides the device with the best possible protection from external damage Please note that the Docon Seal series devices are elec tromechanical devices They must not be thrown If con densation forms...

Страница 48: ...ust 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...

Страница 49: ...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 Input 25 2 V DC 2 A Protection class II T...

Страница 50: ...d components Sealing times 1 5 s Docon SealM Successive sealing procedures For ambient temperature 150 10 C to 40 C Sealing processes battery charge up to 2000 Docon Seal Successive sealing procedures...

Страница 51: ...less than 90 relative humidity Weight with packaging 2400g Packaging dimensions Width x height x depth 340 mm x 80 mm x 300 mm Air pressure 700 1050 hPa Operating conditions Temperature 10 C to 40 C H...

Страница 52: ...increase emission levels or reduce the interference resistance of the 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...

Страница 53: ...e acc to CISPR 11 Group 2 The Docon SealM must emit electromagnetic energy to ensure that it performs its in tended function Electronic devices in the vicinity could be influenced RF electromagnetic i...

Страница 54: ...function Electronic devices in the vicinity could be influenced RF electromagnetic interference acc to CISPR 11 Class B Application area see Chapter 4 6 Harmonic emissions acc to IEC 61000 3 2 Class...

Страница 55: ...ial the relative humidity should be at least 30 15 kV air dis charge 15 kV air dis charge Power fre quency 50 60 Hz magnetic field acc to IEC 61000 4 8 30 A m 30 A m Magnetic fields of the supply freq...

Страница 56: ...MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propa gation is affected by absorption and reflection by structures objects...

Страница 57: ...scope of delivery included an approved charger that has already passed these tests Electrical fast transients bursts acc to IEC 61000 4 4 Surges IEC 61000 4 5 Voltage dips short interruptions and volt...

Страница 58: ...Surge voltages surges IEC 61000 4 5 1 kV differ ential mode 1 kV differen tial mode The quality of the supply voltage should be compara ble to that for a typical shop or hospital environment Surge vol...

Страница 59: ...ntinued operation during power mains inter ruptions it is recommended that the device be powered from an uninterruptible power supply Power fre quency 50 60 Hz magnetic field acc to IEC 61000 4 8 30 A...

Страница 60: ...ction of the de vice s performance Radiated HF disturb ance value acc to IEC 61000 4 3 10V m 80 MHz to 2 7 GHz Table 9 of IEC 60601 1 2 Ed 4 10V m 80 MHz to 2 7 GHz Table 9 of IEC 60601 1 2 Ed 4 Notes...

Страница 61: ...601 1 2 Edition 4 table 4 to 9 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...

Страница 62: ...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 9 4 2 Docon Seal See Chapter 9 3 2 9 5 Acc...

Страница 63: ...5981 Docon SealM power adapter UK 93005985 Docon SealM power adapter US 93005986 Docon SealM power adapter AU 93005989 Instructions for use EN Docon SealM Docon Seal 9306028 Docon Seal item numbers an...

Страница 64: ...con Seal 9306028 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 o...

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Страница 68: ...ersion 0086 02 02 Order number for instructions for use REF 93006028 M ller Medical GmbH Wasserkuppenstra e 29 31 36043 Fulda Germany Tel 49 0 661 94 19 5 0 Fax 49 0 661 94 19 5 850 http www moeller m...

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