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Durr Dental 6024100001, Инструкция по установке и эксплуатации

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20 Sealing log

After the sealing process, the relevant sealing data is stored in a text file. The file can be saved to the SD
card in the unit or to a connected PC via a documentation program. The individual fields are separated
by a semicolon.

Explanation

1

Hygopac View; item description

2

6024100001; order number

3

xxxxx; serial number

4

yyyyy ; firmware version

5

Time; comprising the date, time and **time zone**.

6

LOT; sequential batch number.

7

Temperature; temperature during the sealing process.

8

Pressing force during sealing.

9

Speed; the speed at which the sealing process took place.

10 Result; this indicates whether the seal was OK.
11 OQ; Daily operating qualification, see "14.2 Daily function assessment".
12 PQ; Annual performance qualification. This entry appears automatically once a year and requests

permission to carry out the performance qualification, see "14.3 Annual Performance Qualification".

Appendix

6024100132L02 1906V003

31

EN

Содержание 6024100001

Страница 1: ...EN Hygopac View Installation and operating instructions 6024100132L02 6024100132L02 1906V003 ...

Страница 2: ......

Страница 3: ...sport locks 12 7 2 Electrical connections 12 8 Commissioning 13 8 1 Monitoring the unit via the net work 13 8 2 Handover of the device 14 9 Configuring the unit 14 9 1 Selecting the access level 14 9 2 Language selection 14 9 3 Set the date and time 14 9 4 Adjusting the temperature 15 9 5 Set the speed for the belt trans port 15 9 6 Set standby time 15 9 7 Configuring the network 15 9 8 Touch scre...

Страница 4: ...4 17 1 Caution messages 24 17 2 Fault messages 24 17 3 Note messages 24 18 Tips for operators and service techni cians 25 18 1 Displaying the sealing parame ters 25 18 2 Fault on the unit 25 18 3 Error messages on the touch screen 25 Appendix 19 Menu structure 29 20 Sealing log 31 Contents 2 6024100132L02 1906V003 EN ...

Страница 5: ...g symbol The warnings are structured as follows SIGNAL WORD Description of the type and source of danger Here you will find the possible conse quences of ignoring the warning Follow these measures to avoid the danger The signal word differentiates between four levels of danger DANGER Immediate danger of severe injury or death WARNING Possible danger of severe injury or death CAUTION Risk of minor ...

Страница 6: ... sterilisation packaging 2 2 Intended use The unit is designed to provide validated thermal sealing for sterilisation packaging in accordance with EN ISO 11607 1 both bags and rolls in the medical sector e g clinics dental practices and medical surgeries 2 3 Improper use Any use of this appliance these appliances above and beyond that described in the Installa tion and Operating Instructions is de...

Страница 7: ...pproved by Dürr Dental Only use only original wear parts and replace ment parts Dürr Dental accepts no liability for dam ages or injury resulting from the use of non approved accessories or optional accessories or from the use of non origi nal wear parts or replacement parts The use of non approved accessories optional accessories or non genuine wear parts replacement parts e g mains cable can hav...

Страница 8: ...20 051 50 10 0 cm x 100 m 6020 052 50 15 0 cm x 100 m 6020 053 50 25 0 cm x 100 m 6020 055 50 3 3 Optional accessories The following optional articles can be used with the unit Hygopac Sealcheck 6022100027 Network cable 9000 119 071 Hygofol Station 6022 600 00 Instrument table 6022 700 00 Hygoprint 6020 080 50 3 4 Consumables The following materials are consumed during operation of the device and ...

Страница 9: ...5 Wear parts and replacement parts Information about replacement parts is available from the portal for authorised specialist dealers at www duerrdental net Product description 6024100132L02 1906V003 7 EN ...

Страница 10: ... approx min 3 Rate of sealing adjustable m min 5 7 9 Tolerance of the set throughput speed Limit values m min 1 min 4 max 10 Sealing seam Total width Sealed width mm 17 13 Pressing force general range N 60 120 Duty cycle 80 S3 30 min Noise level dB A 70 Dimensions W x H x D cm 37 x 17 x 14 Weight kg 7 8 TFT touch screen 2 8 Noise level in accordance with ISO 3744 Ambient conditions during storage ...

Страница 11: ...th responsibility for compiling all technical documentation F Hatzfeld Head of Development Equipment The address is identical to the address of the manufacturer Low voltage guideline 2014 35 EU in its valid version Electromagnetic Compatibility EMC Directive 2014 30 EU in its current version Directive 2011 65 EU on the restriction of the use of certain hazardous substances in electrical and electr...

Страница 12: ...re and the current actual temperature are shown on the touch screen The operator is reminded of the operational qualification every day This is done after the device reaches the target temperature for the first time at the start of working To do this a seam sealing test is per formed and then assessed e g with Hygopac Sealcheck If the seam sealing test is successful this must be confirmed by press...

Страница 13: ...The unit is ready for the next sealing process The unit has a standby mode If this is activated in the menu under System Settings Standby the unit will switch off automatically after the set time if it is not used 30 minutes are preset The unit contains an SD card on which the relevant sealing parameters are saved The data can be transferred to a computer using a card reader Alternatively the data...

Страница 14: ...ce The device warms up during operation keep a good distance to heat sensitive devices A minimum gap equal to the width of the packaging must be provided to the side to allow insertion and removal of the sterile prod uct packaging that is to be sealed Do not cover the ventilation slots 6 3 Information about electrical connections The unit has no main power switch The unit must be set up so that th...

Страница 15: ... the unit The temperature of the device is pre set to 180 C for Hygofol transparent sterilisa tion packaging from Dürr Dental The speed of the belt transport is pre set to Medium Carry out a function check of the device Perform a sealing test If the test seal is not OK adjust the tempera ture and or speed as required 8 1 Monitoring the unit via the network If the device is connected to the network...

Страница 16: ...vel The adjustment options depend on the selected access level Only a qualified expert is permitted to change the settings in the Service Techni cian access level Access level Rights Operator Querying device information Sealing parameters Administrator In addition to the User rights System settings administra tive For operators e g hygiene officer Service Tech nician In addition to the Administrat...

Страница 17: ...etwork After the network settings have been changed it is necessary to restart the device This saves the changed settings Requirements ü Access level Administrator or Service Techni cian selected If DHCP is activated then the settings are applied automatically Deactivate DHCP if you wish to adjust the settings manually Tap System Settings Network Deactivate DHCP Tap IP Address enter the data and t...

Страница 18: ...start screen appears on the touch screen LOT 123456 10 07 12 10 2018 Aufheizen auf 180 C 80 C Folientransport press the touch screen and keep pressing until the symbol appears Press the centre of the circle and keep press ing until the colour changes to green Drücken Sie in die Mitte des Kreises Repeat this process at three different points these are automatically chosen 1 2 3 The display then sho...

Страница 19: ...are various recommendations for working with sterile product packaging Select sufficiently large packaging Only fill packaging to 75 of its capacity to ensure that the sealing seams are tension free The distance between the sealing seam and the sterilised material should be at least 3 cm To the packaging from being cut or pierced sharp instruments should be covered with suit able protective equipm...

Страница 20: ...iew shows all currently active messages Here the messages are divided into the following categories Fault Unit will no longer function When the error has been remedied it may be neces sary to acknowledge the error message Notice After acknowledgement the unit will continue to work but only with limited functions Note Important information for the operator e g about the current status of the device...

Страница 21: ...oil remains in the device without an error message being generated Place the sterilisation packaging up against the stop this is the only way to ensure that the light barrier will be trig gered Observe the maximum foil width of 75 cm Assess the sealing seam after process is com pleted see 14 2 Daily function assessment Label the packaging with the expiry date and required additional information e ...

Страница 22: ...e work is due For further information please refer to the VistaSoft Monitor manual order number 2110300001 13 Adjustment of the adjustable stop The adjustable stop allows the distance between the sealing seam and the edges to be adjusted to one of four different distances max 30 mm min 15 mm The foil protrusion provides sufficient material for opening the sterilisation pack aging and thus ensures ...

Страница 23: ...es in the Seam sealing test OK screen to switch the unit to ready for operation If the outcome of the operational qualifica tion is not satisfactory tap No in the Seam sealing test OK screen The following appears on the screen Please adjust temperature Tap OK Adjust the temperature directly via the menu as required Tap Save Repeat the operational qualification If the operational qualification is u...

Страница 24: ...lowing output media and to archive them accordingly SD memory card Computer via the network 15 1 Securing the sealing log Remove the SD card from the unit Read the sealing records see 20 Sealing log on the PC and save them After saving the data delete the sealing records from the SD card Insert the empty SD card into the unit We recommend taking out the SD card at regular intervals and additionall...

Страница 25: ...he products specified in these instructions have been subjected to material compatibility testing by Dürr Dental Read the operating instructions for the disinfectants Wear protective gloves 16 1 Unit surfaces The unit surface must be cleaned and disinfected of any contamination or visible soiling Dürr Dental recommends using the disinfectants FD 322 FD 333 and FD 350 NOTICE Liquid can cause damage...

Страница 26: ...ed for too long Sealing speed too high Please repeat the sealing process Sealing speed too low Please repeat the sealing process 17 2 Fault messages The unit will no longer function When the error has been remedied it may be necessary to acknowledge the error message Message Fault Power supply unit defective Device overheating Please wait Temperature sensor defective Foil transport blocked Heating...

Страница 27: ... card has been inserted Insert an SD card when the unit is switched off If no SD card is to be used deactivate the function in the menu SD card not detected Remove the SD card with the unit switched off and re insert it SD card write protected Remove the write protection SD card defective Replace the SD card with a new one SD card write error Restart the device SD card defective With the device sw...

Страница 28: ...f a persistent fault contact a Service Tech nician Pressing force set incorrectly Pressing force too low Please repeat the sealing pro cess One off fault Please repeat the sealing pro cess Defective force measuring sys tem Acknowledge the message Check the sealing seam for dirt and inclusions Check the pressing force in the load free state via the menu under Sealing Parameters see also 18 1 Displa...

Страница 29: ...sistent fault contact a Ser vice Technician Speed measuring system defec tive Sealing speed too high Please repeat the sealing pro cess One off fault Repeat the sealing process Speed measuring system defec tive Acknowledge the message Carry the foil along with the same speed that is specified by the unit or use an instru ment table Check the trans port system for any visible signs of dirt or conta...

Страница 30: ...t or broken cable Inform your Service Techni cian Heating defective It is possible that the heat up phase is not reached Inform your Service Techni cian Pressing operation defective The pressing force is possibly insufficient Inform your Service Techni cian Motor current blocked The mechanical system is possi bly stiff sluggish Inform your Service Techni cian Troubleshooting 28 6024100132L02 1906V...

Страница 31: ...ings Language 1 3 German DE English EN Date time 2 3 Automatic Enabled Disabled Date Time Time zone UTC 2 Network 2 3 DHCP Enabled Disabled MAC IP address 000 000 000 000 Netmask 000 000 000 000 Gateway 000 000 000 000 Syslog IP address 000 000 000 000 Syslog port 514 Syslog heartbeat Enabled Disabled Standby 2 3 Enabled Disabled Validation 1 3 Operational qualifica tion Performance qualifi cation...

Страница 32: ...B SN Device usage data LOT Operating hours Path counter Alarm history 3 see 17 1 Caution messages 1 Visible from access level Operator or higher 2 Visible from access level Administrator or higher 3 Visible from access level Service Technician or higher Appendix 30 6024100132L02 1906V003 EN ...

Страница 33: ...e comprising the date time and time zone 6 LOT sequential batch number 7 Temperature temperature during the sealing process 8 Pressing force during sealing 9 Speed the speed at which the sealing process took place 10 Result this indicates whether the seal was OK 11 OQ Daily operating qualification see 14 2 Daily function assessment 12 PQ Annual performance qualification This entry appears automati...

Страница 34: ......

Страница 35: ......

Страница 36: ...Hersteller Manufacturer DÜRR DENTAL SE Höpfigheimer Str 17 74321 Bietigheim Bissingen Germany Fon 49 7142 705 0 www duerrdental com info duerrdental com ...

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