Manual Rotary Heat Sealers Type: F108TX-P/USB PROTEC List of Content: Page:

INTRODUCTION 2

GENERAL DESCRIPTION 2

APPLICATION 4

SAFETY PRECAUTIONS 5

TRANSPORT AND STORAGE 6

INSTALLATION 7

FIRST SET UP 8

CONNECTION DRAWING 9

OPERATING INSTRUCTIONS 10

CONTROL PANEL 10

MENU SETTINGS 111 ALARMS 16 CHANGING THE TEMPERATURE 17

TEMPERATURE CONTROL 18

DAY COUNTER 19

CHANGING THE COUNTER SIGNAL 20

MAINTENANCE & SUPPORT 21

PREVENTIVE MAINTENANCE 21

TECHNICAL DATA 21

MAINTENANCE 22

ACCESSORIES AND REPLACEMENTS 23

TROUBLESHOOTING 24

SUPPORT 24

TECHNICAL DRAWINGS 25

CERTIFICATE OF CONFORMITY 27

TEST CERTIFICATE 28

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Introduction Thank you for selecting and purchasing a Famos Heat Sealer. These instructions include information on the machine, its function, and operation. 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 from the date of the delivery; 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 & Support’ or contact your local supplier.

Yours Sincerely,

Famos bv

Statement to this manual Famos bv reserves all rights to modify these operating instructions. Famos bv has made all possible efforts to make this manual free of inaccuracies and omissions. If you note any errors or unclear points, please advise us. Trademarks The F108TX-P/USB PROTEC® is a trademark of Famos bv , All rights reserved. Proprietary Notice The digital embedded software included in your heat sealer is Copyright to the manufacturer © 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 the Manufacturer. Copyright © Famos bv The right to make changes is reserved.

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GENERAL DESCRIPTION This heat sealer is especially designed for the heat sealing of sterilization packaging material used to protect instruments. Sealing other materials than indicated in the section ‘Application’ on page 4 could cause serious damage to the heat sealer and all resulting costs will not be covered within the guarantee period. If there are any doubts that your Famos heat sealer is suitable to seal your packaging material, contact your dealer or Famos directly. All Famos rotary heat sealers conform to the German Directives (DIN 58.953 part 7) that are drawn up for sealing packing material as indicated in section ‘Application’. The Famos heat sealer is NOT a medical device as per the current Medical Device Directive (MDD).

Use of the sealers is not allowed 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.

The sealer can be used by children of 8 years and older as well as by individuals who have a diminished capability physically, sensorially or mentally or a lack of experience or knowledge, under condition that they are either being supervised or that they have been taught how to use the sealer securely and that they understand the dangers which can occur. Children are not allowed to play with the machine. Cleaning and user’s maintenance cannot be used by children without supervision.

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APPLICATION

The Famos rotary heat sealer is suitable for sealing the following sterilization materials:

Laminate packing material

Paper packing material suitable for heat sealing

Tyvek® packing material (if sealer is manufactured as a Tyvek sealer) For the correct temperature setting of the heat sealer for the different packing materials refer to the manufacturer of these packaging materials. The Famos rotary heat sealer is not suitable for sealing the following material:

Polyethylene foil

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 other 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).

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SAFETY PRECAUTIONS

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. 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. 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. Automatic feed-in Although the automatic packaging 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. 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 shall not be used.

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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 cannot move within its box. Using other packaging materials than the originals can lead to damage both inside 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 original 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.

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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. Before unpacking, please check whether the packaging is OK. If this is not the case please notify the forwarder to claim transport damages. Famos bv is not responsible for these damages and does not accept any claim arising from this. 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 for sealer

RS 232 cable (only for models with parameter control)

Ethernet converter (RS232 to Ethernet) (only for Ethernet models)

Power supply cable for converter (only for Ethernet models)

CD-ROM with: o Sealer Monitor USB software

(only applicable for F108TX-P and DEP/DBC models)

Manual Sealer Monitor USB software (only for F108TX-P and DEP/DBC models) An Ethernet cable is not included. In order to guarantee correct function it is recommended to install the heat sealer at a spot where the machine:

has enough space for ventilation.

it is not exposed to direct sunlight or some other heat source.

it is not subject to vibrations or shocks.

it is dust free. Direct sunlight can activate the transportation mechanism within the machine which is switched on by an optic-sensor which is sensitive to light (for F108TI and F108TX only).

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FIRST SET UP

1. Verify that the on/off switch is off (please refer to drawing ‘rear side view’ in section Connection Drawing). If the on/off switch is positioned at 0 it means that the machine is switched off.

2. 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 APPROVED. 3. 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 approximately 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.

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)

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CONNECTION DRAWING Rear view of the Heat Sealer

For F108 and F108TX PROTEC the RS232 connection can be used for software updates. For the F108TX-P/USB the RS232 connection can also be used to read out parameters in an external software program.

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OPERATING INSTRUCTIONS

Control Panel

Keys Temperature adjustment Adjusting the sealing temperature

Reverse transport key Transporting the packaging to the left

Production counter Adjusting the production counter

Production counter alarm Setting the alarm for the production counter

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Menu Settings

While switching the machine on the following screen is displayed:

This screen is displayed for 3 seconds. When pressing the button within these three seconds the following screen will appear:

By pressing the button one can run through the next 6 settings: - Language - Date - Time - Force upper limit - Service counter - Total counter - Monitor - USB firmware

Changing a setting can be done by pressing the button and then scroll through with the and the button. You can confirm your setting by pressing .

To leave the settings menu press the button.

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Language In the language menu as displayed on the previous page, one can change the operation language.

Date In this menu the date can be changed.

Time In this menu the time can be changed. Force upper limit

By using the force upper limit you can set the limit at which force the machine will give an alarm. The preset limit of 120 Newton is recommended. When the pressure would be higher than 120 Newton during the sealing process the machine gives an alarm. To change the setting to have the machine give an alarm earlier (when pouches for example are fed in double) just set the limit down to 110-115 Newton. The machine should only give an alarm in case of a bad seal or when pouches are being fed in double. However, in case the machine gives an alarm even though the seal is good, the upper alarm limit should be set higher.

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Service counter

The service counter menu shows the quantity after which the heat sealing machine gives an alarm for service. Recommended is to set the quantity to the amount of seals which are made during six months. This means that the machine would give an alarm every six months to remind you on the service needed. In order to increase the quantity at which the sealer should give alarm, press the button to enter the service counter menu. Then press the button to increase the quantity and confirm your setting by pressing the button. To reset the alarm press the button within 5 seconds after the alarm. The counter starts counting again as from zero until it has reached the set service counter.

Total counter

Total counter menu shows the total amount of seals made with your heat sealer.

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Monitor

The F108TX-P-USB/ETH is equipped with a so-called “In-Process check” to check the most vital seal parameters, which are:

- Temperature - Sealing Speed - Force

The values of these three parameters are continuously monitored for each and every seal that is made by this machine and the values are being indicated in the Monitor menu. Due to this feature the quality of all seal parameters is constantly checked. When one of the parameters is out of tolerance the sealer will indicate this through its LCD-display and warn the user by a beep. More details about these alarms can be found further in this manual.

When you are not in the monitor screen and you are in the menu screen while sealing, the parameters will be shown as well.

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The machine is equipped with a USB-module which is located at the back of the machine. When you connect a USB stick to the module, a log will be made of the parameters of each seal. The number of the seal is being indicated in the file Each log will look like this: Identification Number of seal, date; time; temperature ; pressure ; speed. These logs will be stored on the stick in a text file called LOG.txt. This file can be read out on a pc. For the F108TX-P-USB/ETH a software program is available which allows you to view and monitor the parameters real time. This program is to be installed on a pc. The sealer can be connected to a pc by means of the RS 232 port at the back of the machine. This software program is not standard included and is available on request. USB firmware With this option you can easily update the software. Connect the USB stick with the latest software version to the USB port at the back of the machine.

Press the button. Now you will be asked if you are certain that you want to update the software. Press to confirm. Now the software will be updated.

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Alarms

The machine is equipped with a pressure alarm. The upper limit is preset at 120N, but it can be adjusted in the force upper limit menu as explained on page 12. The lower limit is fixed on 90 Newton and cannot be changed. When the pressure would be outside the limits, the above shown alarm is shown. The machine is also equipped with a speed alarm which cannot be changed by the user. When the sealing speed drops underneath 8 meters per minute the above shown alarm is shown. All alarms can be confirmed with the button on the keyboard.

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Changing the Temperature

Press one of the two buttons or and keep it pressed for two seconds until the following screen will appear:

By keeping one of the two buttons or pressed the temperature will start to run random from 50°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 of 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 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 Famos dealer for assistance.

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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, during 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.

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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.

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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 and keep it pressed for two seconds until the following screen appears.

By keeping the button or 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 or one can switch on or off the counter signal. 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.

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MAINTENANCE & SUPPORT

Preventive Maintenance

In order to guarantee 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.

12.210.300 Transport belts

30.200.039 Teflon strip on heating elements

30.200.041 Teflon strip on guiding bars

30.100.174 Timing belt pulley

For the article numbers and descriptions of all other parts we refer to your Famos dealer and/or to the technical documentation.

Technical Data

Temperature range : 50 - 199 °C

Running speed : 8,5 m/min ± 5%

Seal seam width : 12mm (flat seal), 15mm (rib seal)

Sealing force : 100 ± 5% 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 70 W

Main voltage : 220/240VAC 50/60Hz, 100/120 VAC 60Hz

Dimensions : 438x289x137 mm

Weight : 12 Kg To avoid the risk of electric shock do not open the casing of the sealer. Repairs should be undertaken by experts only.

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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 twice 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.

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ACCESSORIES AND REPLACEMENTS

The following accessories and parts are available:

Accessories

Part.# Description 30.100.623 Front table for Famos F108 PROTEC models 30.100.620 Roller front table for Famos F108 PROTEC models

Spare parts

Famos bv 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.

Part.# Description 12.210.300 Transportation belts (2 pcs / sealer) 30.200.039 Teflon strip for heating elements (2 pcs / sealer) 30.200.041 Teflon strip for guiding bars (2 pcs / sealer) 30.100.174 Timing belt pulley ( 3 pcs / 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.

Part.# Description 29.330.058 Keyboard Famos F108T / TX 98.200.089 Display Famos F108 98.200.120 Fan assembly F108 / F110 / F220 PROTEC 60x60x25mm 98.200.112 Main PCB board Famos F108 98.200.044 Motor 220/240VAC 98.200.093 Motor 100/120VAC (JAPAN/ USA)

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TROUBLESHOOTING

Malfunction Possible Cause Solutions

No display, fan Power supply Check power cable Check if power supply is switched ON

Temperature is not reached

Wrong temperature setting Check temperature setting in menu

Seal is not OK Temperature Service

Check temperature settings in menu Have the machine checked by your local Famos dealer

Machine gets hot Fan is broken Change fan (machine can get warm after switching off while the fan stops running. This is normal.)

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 the Famos distributors have spare parts in stock. These are readily available. If you don’t know your local Famos distributor, please contact Famos bv directly at service@famos.nl or call +31-77-354.88.00 - 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 www.famos-medical.com has details of our product range as well as further contact details.

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Technical drawings

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Certificate of Conformity

and

Certificate of Origin

EC declaration of compliance

In accordance with Appendix 11 sub A of Directive 2006/42/EC 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 2006/42/EC

European standard EN 60335-1:2012-16 EN 60335-2-45:2012-08 ZEK 01.4-08

EMC guideline (Richtlinien 89/336/EEG)

Low voltage guideline 2006/95/EG

ISO 11607-2

DIN 58953:7:2010

All heat sealers have been fully tested and comply with the latest European guidelines for heat sealing machines.

Product Type F108TX-P-USB from 1-9-2014 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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