Moller Medical Docon 7 Скачать руководство пользователя страница 4

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Docon

Contents

Page 4 of 74

Contents

General safety information .......................................................................... 8

1.1

Explanation of the safety symbols employed ............................................................8

Symbols in the instructions for use ...............................................................8

Symbols on the device .................................................................................8

Symbols on the display ................................................................................9

Symbols on the retail packaging ...................................................................9

1.2

Explanation of the format conventions employed ................................................... 11

1.3

Manufacturer's responsibility .................................................................................. 11

1.4

Operator's obligation to exercise diligence ............................................................. 11

1.5

Non-product-related additional equipment .............................................................. 13

Intended use ............................................................................................... 14

2.1

Proper use - intended use ...................................................................................... 14

2.2

Combination with other products ............................................................................ 14

2.3

Essential performance features .............................................................................. 14

Product description ................................................................................... 15

3.1

Control elements .................................................................................................... 15

Touchscreen .............................................................................................. 15

Reset button ............................................................................................... 15

3.2

Tray ........................................................................................................................ 15

3.3

Clamp..................................................................................................................... 16

3.4

Device handles ....................................................................................................... 16

3.5

Accessories and options ........................................................................................ 16

Docon 7 mobile II LSC ............................................................................... 16

Holder for Docon 7 mobile II LSC ............................................................... 17

Docon 7 Basic Barcodereader .................................................................... 18

Docon 7 status indicator ............................................................................. 18

Docon 7 sealing option

– sealing handle .................................................... 19

Docon 7 battery .......................................................................................... 23

Docon 7 transport case .............................................................................. 25

Содержание Docon 7

Страница 1: ...Docon Blood mixing scales 7 Instructions for use en...

Страница 2: ......

Страница 3: ...lated in any way whatsoever without prior written approval from M ller Medical GmbH The status of the information specifications and figures in these instructions for use is indicated by the version n...

Страница 4: ...exercise diligence 11 1 5 Non product related additional equipment 13 2 Intended use 14 2 1 Proper use intended use 14 2 2 Combination with other products 14 2 3 Essential performance features 14 3 Pr...

Страница 5: ...switch on 34 Switch off 34 4 4 Operation with other devices 34 4 5 Suitable operating environment 34 4 6 Operation in IT networks 35 4 7 Use of RFID tagged blood bag systems 35 Preparation of the blo...

Страница 6: ...uage submenu 51 Locale submenu 52 Donation submenu 53 Communication submenu 53 Validation submenu 54 Info submenu 55 6 2 Remedying of errors 55 6 3 Service 57 7 Care 58 7 1 Cleaning and disinfection 5...

Страница 7: ...Docon 7 Contents Page 7 of 74 Docon 7 Seal 65 Docon 7 RFID 66 Docon 7 WLAN option 67 9 3 Electromagnetic immunity 68 9 4 Recommended separation distances 70 9 5 Accessories 71...

Страница 8: ...nel and also avoiding damage to and malfunctioning of the device Symbols in the instructions for use Caution Information Symbols on the device Caution hot surface Sealing handle Tissue burns can resul...

Страница 9: ...the display A USB memory stick is connected Docon 7 is connected to the power supply Clamp open Clamp closed Battery operation charge level display Battery indicator while charging Akkuanzeige beim La...

Страница 10: ...itation Temperature limit Manufacturer Date of manufacture YYYY MM DD Total length Caution Fragile handle with care Top store the right way up Attention Under US Federal law this device may be only so...

Страница 11: ...and national deviations are observed The conditions stated in the technical data are observed The manufacturer undertakes to accept old devices as per the German Electrical and Elec tronic Device Act...

Страница 12: ...60601 1 In such cases a separator e g an isolation transformer approved for medical use must be used Position the Docon 7 during normal donation operation so that the user is able to simply disconnect...

Страница 13: ...ce interfaces must demonstrably satisfy 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 sig...

Страница 14: ...il the general criteria for blood donations are permitted to donate blood e g Guidelines for the Preparation of Blood and Blood Components and for the Use of Blood Components and Guide to the preparat...

Страница 15: ...utton applying gentle pressure Reset button If the Docon 7 stops functioning properly and no longer reacts to the usual inputs press the Reset button This can be found on the rear of the device to the...

Страница 16: ...guarantee maximum safety for donors the clamp is closed immediately in the event of a power failure when operating with a 230 V network This can be countered if the device is fitted with a battery 3...

Страница 17: ...ocon 7 mobile II LSC Depending on the situation at hand the following holders are available for the Docon 7 mobile II LSC Table base Plug in base Swan neck Table assembly system for assembly on the Do...

Страница 18: ...area simplifying reading long barcodes from a shorter distance Figure 3 Docon 7 Basic Barcodereader Docon 7 status indicator The Docon 7 status indicator can be secured in a raised position to improve...

Страница 19: ...sealing handle see Sealing procedure on page 20 The sealing handle corresponds to the electrical safety requirements of a type B applied part as per EN 60601 Only the original sealing handle may be c...

Страница 20: ...handle starts flashing 4 Now open the sealing handle lever and remove the tube 3 5 5 2 Cleaning the sealing handle To rule out any risk to the user pull the connecting cable out of the sealing handle...

Страница 21: ...handle head come into contact 2 Press the plunger pins in on both sides until an audible click is heard see Figure 7 and Figure 8 Use a ballpoint pen or similar to push in the plunger pins 3 Push the...

Страница 22: ...rode and is aligned with the corresponding incision in the handpiece see Figure 11 3 Pull the lever with the electrode on the handpiece until both pins emit an audible click see Figure 12 and Figure 1...

Страница 23: ...ttery in the rear compartment of the case will be auto matically charged If the device only has an internal battery only this battery will be charged Only original batteries may be used with the Docon...

Страница 24: ...rsion battery functionality of the Docon 7 is only ensured by the external battery in the transport case 3 5 6 3 Battery charge display Charging is signalised both on the display and via a LED on the...

Страница 25: ...e the top part of the case on the floor Then place the bottom part together with the Docon 7 on the top part The batteries in the transport case can only be exchanged when the case is open Push the la...

Страница 26: ...designated recess see Figure 18 on the right Finally lower the front of the Docon 7 and lock the lever The device is now ready for operation again The sliding compartment on the rear of the case allow...

Страница 27: ...ion and tighten by hand Ensure that the projection on the connection is inserted correctly in the case section Then place the table top on the aluminium section and also hand tighten using the star sh...

Страница 28: ...the Docon 7 can be trans mitted to a PC It is not included in the scope of delivery CAUTION To allow the stick to be used in the Docon 7 it must be configured accordingly Create a folder named Docon...

Страница 29: ...con 7 see Figure 21 a BNC plug in connector Sealing handle only with Docon 7 with seal option b 2 x USB Reading of donation data via the USB stick External barcode scanner LED status indicator c Power...

Страница 30: ...rt is the system configurer and thus responsible for ensuring that the valid version of EN 60601 1 is observed When connecting a LAN network a suitable hub approved for medical use or a galvanic isola...

Страница 31: ...ayed The symbols shown are explained on page 9 Mains operation If the Docon 7 is supplied with current via the power cord the plug symbol confirms this operating mode Battery operation The current cha...

Страница 32: ...Docon 7 with packaging Width x height x depth 585 mm x 370 mm x 380 mm 4 2 Unpack the device and check the scope of supply The Docon 7 delivery comprises a cardboard box When unpacking ensure that no...

Страница 33: ...r For mobile blood donations place the upper part of the case on the floor then place the bottom part of the case with the Docon 7 on this upper part When the Docon 7 is set up for the first time or w...

Страница 34: ...rm by pressing Shut Down on the dia logue window that appears 4 4 Operation with other devices Never operate the Docon 7 directly for distance see chapter 4 7 beside or in conjunction with other devic...

Страница 35: ...IT components or updating or upgrading devices in the IT network 4 7 Use of RFID tagged blood bag systems By fitting the blood bag systems with RFID tags the Docon 7 can read and write To do so passi...

Страница 36: ...with RFID tags To do this attach tag 1 to the top of the whole blood bag as shown in Figure 25 It must be positioned in the middle on the left and the RFID chip must be aligned with the inside of the...

Страница 37: ...ned at the bottom on the right and again the RFID chip must be aligned with the inside of the system This helps to prevent possible malfunctions from the down stream centrifugation process Figure 27 R...

Страница 38: ...Docon 7 Setup and commissioning Page 38 of 74 Figure 28 RFID tag positions on the bag system Middle tag chip chip Bottom tag Top tag chip...

Страница 39: ...n the tray and that the blood removal tube is not trapped between the clamp and tray if the tray is tilted backward After the tube has been successfully recognised you will be requested to close the c...

Страница 40: ...eturn to the donation screen Inflow error messages The Docon 7 can monitor inflow in ml per minute The inflow is only measured when the system is resting just before the tray starts to swing again It...

Страница 41: ...Signal description on display Inflow too low Paused audio No Overview of signal status for Inflow too high Physiological signal status Measured inflow too high Technical signal status N A Signal limi...

Страница 42: ...verall weight of the stored blood including the bag system is shown You can freely select how g and ml are displayed when adjusting the settings The Docon 7 has once again been set to the basic settin...

Страница 43: ...updates Data management via WLAN manually and in online mode Bidirectional data transmission Creation reading and writing of setup files The software is available in the most diverse languages and is...

Страница 44: ...rred Now press the Data button to transfer the donation data The data counter goes back to zero after a successful transmission Process data In order to make the EDP data available to the blood bank t...

Страница 45: ...g submenu and make settings there 2 Make your settings and confirm by pressing Accept to save the parameters and return to the system menu 3 Only press Cancel if you wish to return to the system menu...

Страница 46: ...pecified only text box is shown here Maximum value Not specified only text box is shown here Figure 30 Password submenu display on the Docon 7 1 Press the Password button to open the setting area 2 Cl...

Страница 47: ...th additional activation of the menu item Communication Options submenu The relevant device options can be imported with this setting Option 1 WLAN Option 2 Sealer Option 3 Scanner Option 4 RFID Activ...

Страница 48: ...se note that operation with batteries implies greater brightness and higher power consumption The minimum display brightness is limited to a minimum value to ensure that the Docon 7 can be operated wh...

Страница 49: ...Minimum value 0 Maximum value 100 1 Press the Display button 2 Regulate the volume of the audio signals using the slider or the buttons 3 Press Accept to confirm and save the settings Energy submenu...

Страница 50: ...uch the display briefly to turn it on again 6 1 4 2 Switch off the Docon 7 With this setting you define the switch off time for the Docon 7 if it is not operated If this function is not desired set th...

Страница 51: ...by clicking on the relevant option 3 Press Accept to confirm and save the setting Language submenu Define the desired language setting here Figure 34 Language submenu display on the Docon 7 1 Press t...

Страница 52: ...time Figure 35 Locale submenu display on the Docon 7 1 Press the Locale button 2 Make the desired settings Date and time Set the correct date and time using the and buttons Date time format Press the...

Страница 53: ...and graphic adaptions can be made Figure 36 Donation submenu display on the Docon 7 1 Press the Donation button 2 Select one of the desired setups by touching the relevant button 3 Press Accept to con...

Страница 54: ...Figure 37 Communication submenu display on the Docon 7 Validation submenu This function enables the 500 g validation of the Docon 7 to be repeated or checked An internal data set is saved for each val...

Страница 55: ...ncel button 6 2 Remedying of errors A number of errors are listed in this chapter which could occur in connection with Docon 7 Several possible solutions are given for each error The solutions propose...

Страница 56: ...bout a change the device must be checked by the service team The wrong fields are se lected when entering data via the touchscreen In this case the device must be checked by the service team Problems...

Страница 57: ...must be carried out in order to rule out the possible risk of infection Consumables must be disposed of as per the hygiene guidelines Manufacturer M ller Medical GmbH Wasserkuppenstr 29 31 36043 Fulda...

Страница 58: ...nded disin fectant Meliseptol During disinfection follow the instructions of the disinfectant manu facturer Ensure that the cleaning agents and disinfectants have completely evaporated before using th...

Страница 59: ...orted in the cold and set in a warm room the Docon 7 must not be switched on until the condensa tion water has evaporated Please note in particular any water on the battery contacts and the sealing ha...

Страница 60: ...European Directive 2012 19 EU on waste electrical and electronic equipment WEEE2 applies to this device This device thus bears the symbol with a crossed out bin on the rating plate Return devices and...

Страница 61: ...ireless transfer of donor data also possible online 2 Seal option Sealing of the blood removal tube directly at the donor s bed 3 Optional internal battery 4 RFID option If required the desired device...

Страница 62: ...erating life 10 years Electrical connection Voltage 100 240 VAC alternating current Frequency 50 60 Hz Current consumption 1 10 0 46 A Power consumption 110 VA Current consumption seal version 1 75 0...

Страница 63: ...ty Air pressure Operating altitude 30 to 75 relative humidity 790 1050 hPa 3000 m Sound level Signal sound pressure level 73 5 dB A 3 5 dB A Noise level of the blood mixing scale during routine use wi...

Страница 64: ...n 7 Notes Page 64 of 74 External battery Type Lithium ion battery Voltage 22 2 V Capacity 4500 mAh Energy 99 9 Wh Internal battery Type Lithium ion battery Voltage 22 2 V Capacity 3000 mAh Energy 66 6...

Страница 65: ...ces in the vicinity could be influ enced RF electromagnetic interference acc to CISPR 11 Class B For areas of application see chapter 4 5 Harmonic emissions acc to IEC 61000 3 2 Class A Voltage fluctu...

Страница 66: ...magnetic interference Compliance Electromagnetic environment guidelines RF electromagnetic inter ference acc to CISPR 11 Group 1 To satisfy its intended function the Docon 7 has to emit electromagneti...

Страница 67: ...50 5 825 GHz 802 11g ISM band 2400 2 4835 GHz Effective radiated power ERP Frequency range MHz IEEE standard 802 11 Effective radiated power ERP 2400 2483 5 b 89 536 mW 2400 2483 5 g 93 541 mW 2400 24...

Страница 68: ...l commercial or hospital environment Voltage dips short in terruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles...

Страница 69: ...closer to any part of the Docon 7 including ca bles than the recommended separation distance calculated from the equation applicable to the frequency of the trans mitter Recommended separation distan...

Страница 70: ...TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured...

Страница 71: ...Number 00003674 Docon 7 RFID modification kit Article Number 92016029 Docon 7 mobile II LSC Article Number 00003739 Docon 7 Status Indicator Article Number 00003717 Docon 7 Transport Case Article Num...

Страница 72: ...f 74 Docon 7 Transport Case Basic Article Number 00003919 Docon 7 Transport Case Basic Article Number 00003818 Docon 7 WALN Router Article Number 00003855 Docon 7 Scanner Cradle with swan neck short A...

Страница 73: ......

Страница 74: ...version 0079 00 01 M ller Medical GmbH Wasserkuppenstrasse 29 31 36043 Fulda Germany Tel 49 0 661 94 19 5 0 Fax 49 0 661 94 19 5 850 www moeller medical com info moeller medical com Order number for...

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