Manual Rotary Heat Sealers. Type: F108TX. List of content : Introduction 2. General description 3. Application 4. Safety precautions 5

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1 Manual Rotary Heat Sealers Type: F108TX List of content : Page: Introduction 2 General description 3 Application 4 Safety precautions 5 Transport and storage 6 Installation 7 First Set-up 8 Connection drawing 9 Operating instructions Maintenance & Support - Preventive Maintenance 16 - Technical data 16 - Maintenance 17 - Accessories and replacements 18 - Troubleshooting 19 - Technical drawings Support 23 Documents - Declaration of conformity 24 - Test certificate 25

2 Introduction Thank you for selecting and purchasing a Famos Heat Sealer. This machine is an excellent choice which safeguards and enhances the packaging of your instruments for many years. Famos has put a lot of effort into the design and production of this heat sealer and guarantees the availability of spare parts for a minimum of ten years after the equipment has been supplied to you. All Famos Heat Sealers are delivered with a two year warranty after production date with exception of parts which wear and tear due to normal use. All these parts will be available at your local Famos dealer. In case of any requirement for after-sales support, please refer to the chapter Maintenance and Support or contact your local supplier. Yours Sincerely, Famos bv Statement to this manual Famos bv has made an incredible effort to make this manual free of inaccuracies and omissions. However Famos bv assumes no responsibility or liability for: errors contained in this manual, incidental, special or consequential damages arising out of the furnishing of this manual, the use of this manual in operating the equipment, or in connection with the performance of the equipment when so operated. Trademarks The Famos logo is a trademark of Famos bv, All rights reserved. Proprietary Notice The digital embedded software included in your heat sealer is Copyright 2003 Famos bv. All rights reserved. This software may not be reproduced, modified, displayed, transferred, or copied in any form or in any manner or on any media, in whole or in part, without the prior express written permission of Famos bv Copyright Copyright 2005 Famos bv, Noorderpoort 20, 5916PJ Venlo The Netherlands. All rights reserved. This document may not be copied, in whole or in part, not transferred to any other media or language, without prior written permission of Famos bv.

3 General description This heat sealer is especially designed for the heat sealing of packaging material used to protect instruments. Sealing other materials than indicated on page 4 could cause serious damage to the heat sealer and all resulting costs will not be covered within the guarantee period. When there are doubts if your Famos heat sealer is suitable to seal your packaging material, contact your Famos dealer or Famos directly. All Famos rotary heat sealers conform to the Dutch and German Directives (R3280 en DIN Teil 7) that are drawn up for sealing packing material as indicated on page 4. The Famos heat sealer is NOT a medical device as per the current Medical Device Directive (MDD). WARNING Federal law prohibits use of the sealers in the direct presence of patients (for example, in operation theatres). The minimum distance between the heat sealing machines and patients should be 1.5m. WARNING

4 Application The Famos rotary heat sealer is suitable for sealing the following materials: Laminate packing material Sterilization, paper packing material suitable for heat sealing Tyvek (if sealer is manufactured as a Tyvek sealer) For the correct temperature setting of the heat sealer for the different packing materials we refer to the manufacturer of these packaging materials. The Famos rotary heat sealer is not suitable for sealing the following material: Polyethylene foil Soft PVC foil Hard PVC foil Polyamide foil Polypropylene foil The above list is just a small summary of known materials which are not suitable to be sealed with a rotary heat sealer. Many more materials are not suitable to be sealed with this kind of a heat sealer. When you have doubts please contact your Famos dealer. (To seal above mentioned materials please contact your dealer for an alternative Famos sealer).

5 Safety precautions WARNING not to open The heat sealer should not be opened by unauthorized staff to avoid any injuries caused by electric shock or by the transport mechanism. WARNING Guarantee and warranty will become void as soon as the heat sealer has been opened by unauthorized staff without prior written permission by Famos bv. WARNING Ventilator Obstructing the ventilator at the bottom of the heat sealer could cause overheating to the electronic components within the heat sealer. This could cause serious damage to the heat sealer. Please check the cleanliness of the finger protector grill of this ventilator regularly, to avoid clogging which will cause improper cooling. Cleaning the grill should be done with the power supply socket disconnected from the heat sealer. WARNING WARNING Automatic feed-in Although the automatic paper feed-in of the heat sealer is protected, one should prevent small articles (like small tips of instruments) from being fed in together with the packaging. These objects may cause internal damage to the transportation mechanism as well as to your instruments. Never put objects other than packaging material into the heat sealer. WARNING WARNING Power supply The only power supply cable which may be used to connect your heat sealer to the power supply socket is the one which is supplied together with the machine. Other power supply cables may not be used. WARNING

6 Transport and storage The heat sealer should always be transported in its original box or appropriate return box provided and stowed in such a way that the machine can not move within its box. Using other packaging materials than the originals can lead to damage on the in- and outside of the heat sealer. For packaging instructions please contact your Famos dealer. There are no special storage instructions except that the casing should be kept dry. Please store the standard transport box, including filling foam, for future use, as you might like to ship the heat sealer for preventive maintenance or calibration. This will ensure a maximum level of protection (if properly placed) against transportation damages.

7 Installation Your heat sealer has been carefully packed and stowed to avoid any damage during transportation. The packaging has been tested and will protect the heat sealer during normal transportation handling. REMARK Before unpacking, please check whether the packaging is OK. If this is not the case please notify the forwarder to claim transport damages. Famos is not responsible for these damages and does not accept any claim arising from this. REMARK Although each delivery has been checked prior to shipment, please check the content. If something is missing please report immediately to your local Famos distributor. The transportation box contains the following: - Heat sealer - Power supply cable - CD-ROM with: o Users manual in printable PDF format o Short manual for basic use of your heat seal o Material sample sealed In order to guarantee correct functioning it is recommended to install the heat sealer at a spot: - where the machine has enough space for ventilation. - where it is not exposed to direct sunlight or some other heat source. - where it is not subject to vibrations or shocks. - where it is dust free. REMARK Direct sunlight can activate the transportation mechanism within the machine which is switched on by an opto-sensor which is sensitive to light (for F108TI and F108TX only). REMARK

8 First set up Verify that if the on/off switch is off (please refer to drawing rear side view on page 9). If the on/off switch is positioned at 0 it means that the machine is switched off. REMARK Connect the power supply cable to the heat sealer first and then to a grounded socket with the correct voltage (according to type label at the rear side of the sealer) by means of the supplied power cable. ALWAYS USE A GROUNDED POWER SUPPLY SOCKET WHICH IS APROVED REMARK Switch the on/off switch to I. At this time the heat sealer s display will mention temperature is too low, please wait. From this moment on it takes ± 5 minutes before the pre-set temperature (at 180 ) is reached. Two beeps will indicate that the pre-set temperature has been reached and the display will switch to the stand-by screen. Now the heat sealer is ready for use. REMARK Before you start sealing your packaging, please check the required temperature level as specified by your packaging material supplier / manufacturer. If the temperature is not 180 C (degrees Celsius), adjust the temperature accordingly (please refer to the operating instructions). REMARK

9 Connection drawing Rear view of the Heat Sealer

10 Operating instructions Content Part 1 General control feasibilities - Control panel 11 - Changing the temperature 12 - Reverse transport 12 - Temperature control 13 - Day counter 14 - Changing the counter signal 15 Famos bv, Venlo. The right to make changes is reserved.

11 Part 1: General control feasibilities Control panel Keys Temperature adjustment Reverse transport key Production counter Production counter alarm Adjusting the sealing temperature. Transporting the packaging to the left Adjusting the production counter To set the alarm for the production counter

12 Changing the temperature: Press one of the two buttons following screen will appear. and keep it pressed for two seconds until the By keeping one of the two buttons pressed (+ or -) the temperature will start to run random from 100 C until 199 C. Release the button when you have reached the required temperature. When the set temperature is reached, insert the packaging material on the left hand of the machine. The optical sensor in the machine will detect the material and the transportation belts will guide the pack through the machine. If packaging material gets stuck in the machine do not try to tear it out. Press the red reverse button and keep it pressed until the material will leave the machine again on the left hand side. If the material does not come out fully, contact your local dealer for assistance.

13 Temperature control The heat sealer will take approximately 5 minutes to heat up from room temperature to 180 C. During the sealing process there can be a small deviation in temperature with a maximum of 5 C, after which the heat sealer will not allow the user to proceed until the set temperature has been reached again. When the new set temperature is higher than the present temperature the heat sealer will show the following screen. The heat sealer will beep when the set temperature is reached. When the new set temperature is lower than the present temperature the heat sealer will show the following screen. The heat sealer will beep when the set temperature is reached.

14 Day counter The day counter is displayed in the right upper corner of the display (#:000). During a day of sealing the counter will show how many packs have been sealed. To reset the day counter press the button for a few seconds. The day counter will now be set on 000 again. After the machine has been switched on and off the day counter will be reset to 000 again.

15 Changing the counter signal: The counter signal is used to warn the user by a beep at the time the pre selected quantity of packs have been sealed. This option is useful when larger quantities of packs have to be sealed. Press the button appear. and keep it pressed for two seconds until the following screen will By keeping one of the two buttons pressed the counter will start to run until a maximum of 999. Release the button when you have reached the required point where you would like to receive a warning. By pressing on of the two buttons signal. one can switch on or off the counter When the heat sealer has given a beep you can set a new counter signal again to the pre-set value entered before. To do this reset the day counter to 000 again.

16 Maintenance & Support Preventive maintenance In order to guarantee an optimal functioning of the heat sealer and in order to prevent corrective maintenance, we advise to have the machine checked and cleaned at least twice a year. During this inspection the following parts are checked on wear and tear and if necessary replaced Transport belts Teflon strip on heating elements Teflon strip on guiding bars For the article numbers and descriptions of all other parts we refer to your dealer and/or to the technical documentation. Technical data - Temperature range : C - Running speed : ± 9 m/min - Seal seam width : 15 mm (grooved seal) 12mm (flat seal) - Sealing force : 100 ± 10% Newton - Fuses : 2 x 3.15AT, 1 x 1,6AT, 1 x 250MAT (220/240VAC) : 2 x 5AT, 1 x 3,15AT, 1 x 500MAT (100/120VAC) - Power consumption : max. 365 W, average 180 W - Main voltage : 220/240VAC 50/60Hz, 100/120 VAC 60Hz - Dimensions : 405x290x160 mm - Weight : 12 Kg Warning To avoid the risk of electric shock do not open the casing of the sealer. Repairs should be undertaken by experts only which are authorized by Famos bv.

17 Maintenance Routine maintenance There is no need for routine maintenance other than regularly cleaning the ventilator on the bottom of the machine. This will prevent dust from clogging the grills of the finger protector, which would result in insufficient cooling. Preventive maintenance The Famos Heat Sealers are subject to preventive maintenance once a year. In some countries a higher rate of preventive maintenance is required by guidelines of the local Central Sterilization Organization. Please check whether this is applicable to your area.

18 Accessories and replacements The following accessories and parts are available: Accessories Art.nr. Description Front table for F108 series Roller front table for F108 series Spare parts Famos will stock spare parts for all its heat sealers, 10 years old or less. In many cases even spare parts for machines older than 10 years are available. When ordering parts it is very important to mention the model number as well as the serial number of your heat sealer. The serial number is displayed on the back of your heat sealer. During preventive maintenance the following parts are checked for wear and tear and if necessary replaced. Art.nr. Description Transportation belts (2 pcs / sealer) Teflon strip for heating elements (2 pcs / sealer) Teflon strip for guiding bars (2 pcs / sealer) Timing belt pulley ( 3pcs / sealer) Replacement parts When ordering replacement parts always mention the serial number of your heat sealer with the order. The serial number is displayed on the back of your heat sealer. Art.nr. Description Keyboard F108TX Display F Fan F108 60x60mm Main PCB board F108 TX Motor 220/240VAC Motor 100/120VAC (USA)

19 Troubleshooting Symptom Possible Cause Solution No Display, fan Power supply Check power cable Check if power supply is switched ON Temperature is Wrong temperature Check temperature setting in menu not reached setting. Seal is not OK Temperature Check temperature settings in menu Service Have the machine checked by your dealer

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23 Support Support is available wherever Famos heat sealers are installed and in operation. - Distributor The official distributor of Famos will be best equipped to support our machines. Famos distributors are trained and skilled professionals who can help you to maintain and repair your Famos heat sealer. In most circumstances Famos distributor have spare parts in stock. These are readily available. If you don t know the Famos distributor, please contact Famos bv directly at service@famos.nl or call Supplier of your packaging materials If the sealing of packaging material is not successful, please contact your supplier of the packaging material as in most cases they will support you in solving your problem. - Direct contact If you cannot find your local Famos distributor, contact Famos bv directly. Our website has details of our product range as well as further contact details.

24 Certificate of Conformity and Certificate of Origin EC declaration of compliance In accordance with Appendix 11 sub A of Directive 98/37/EG which dates from 1998, we hereby declare that the listed products conform with the published specification and comply with the requirements of the following European Directives and Standards and to their current amendments: Machines guideline 98/37/EG European standard EN : A: A1:2004 EN :2003 EN 50366:2003 EMC guideline (Guideline 89/336/EEG) Low voltage guideline 2006/95/EG All heat sealers have been fully tested and comply with the latest European guidelines for heat sealing machines. Product Type F108 series from Certificate of origin Herewith it is certified that the listed equipment has been manufactured in a member state (The Netherlands) of the European Community. Famos bv T.J.E. van Gardingen General Manager

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