During the 1980 s, in order to satisfy an enquiry from an important North American company in the medical field, Gandus Saldatrici designed and began

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2 During the 1980 s, in order to satisfy an enquiry from an important North American company in the medical field, Gandus Saldatrici designed and began to manufacture their first sealer for medical pouches. Over the following years Gandus Saldatrici has become one of the European leaders in the market. With its varied range of ten models Gandus Saldatrici can now satisfy any packaging needs of medical disposables in either pre-made pouches or reels. Every year Gandus Saldatrici invests 50% of its R & D budget in developing their medical sealers. Thanks to this, during the last five years Gandus Saldatrici has been able to launch a new model into the market every ten months. After developing the sealing and coding technologies, the company is now focussed on the technical solutions required to ensure seal repeatability and function parameter recording to fully comply with ISO standards. In order to satisfy the increasing demand for total control and traceability of the sealers functions, in conjunction with its top of the range models, Gandus Saldatrici can now also supply two software versions, to record, store and manage the three sealing parameters; temperature, time and pressure.

3 All the models are designed and manufactured to ISO 9001:2000 quality standards. The company s experience has matured during the years and considered unique and the level of service offered we believe gives a strong competitive advantage. Furthermore Gandus Saldatrici proudly assures short delivery times, always available spares and innovative solutions.

4 minirò H-net In order to improve traceability of the packaging products in the medical market, Gandus Saldatrici designed the minirò H-net which has the highest specifications in the Gandus range of sealers for medical disposables and fully meets the ISO11607 standard. It is equipped with an electronic printer which is connectable with external units. Due to constant technical improvements the minirò H-net assures the repeatability of seal results constantly monitoring all the important function parameters (temperature, speed and pressure) Technical features minirò H-net has been designed for large volumes both in the hospital and medical industry. It will seal at 10 mts/min The LC Display has 4 lines with 24 characters in each one. One of the main features of the very reliable machine is the alphanumeric membrane keyboard. Seal Multi-line sealing 15mm width, with temperature adjustment with + or 1% tolerance, to fully satisfy ISO standards. Interfaces Three Com Ports placed in the rear side of the machine allow connection of the sealer to external units: label printer, personal computer, palmtop, or optical scanner.

5 Functions The highly developed minirò H-net allows settings of more than 30 functions, from the password to the management of the data storage, date formats, printer settings, counters, language choice and the maintenance menu. Programming All program functions can be easily set from the built in membrane keyboard. To make it easy and avoid any possible mistakes Gandus Saldatrici has introduced the Bar Code Designer. This software when installed on a PC creates in an easy and quick way, a sequence of printing steps in bar code format, which represent all the settable functions. The operator can set the sealer reading the pre-set data through an optical scanner linked to the machine, quickly and very simply avoiding any mistakes. Data storage Remote Management Software allows the machines functioning data to be stored, in order to assure traceability of the sealing parameters according to the pouch and/or the working time. This software allows this machine and the minirò H- net VP to be connected to a palmtop and PC allowing all the sealing parameters to be downloaded. These records can then be stored on the PC and managed in Excel. Sealing parameters control minirò H-net VP version monitors the correct function of all the parameters in real time, constantly monitoring that the temperature, pressure and speed are within the set tolerances. Should any be out of tolerance the machine will immediately stop. A printout showing temperature, pressure and speed values can be produced to confirm the correct setting of sealing parameters. Printing The built-in dot matrix printer will print dates, batches, codes and any other information directly on the pouch during the sealing phase. It can also be connected to an external thermal printer to print bar codes or other data on adhesive labels. Alarms and safety minirò H-net is equipped with different alarms to help monitor correct functioning control. An audible alarm sounds and the machine will stop to indicate incorrect sealing parameters, ink cartridge empty, exhausted battery or scheduled maintenance is due. Maintenance and Service All sealers are supplied with a Test and Conformity Certificate. Gandus Saldatrici offers a periodic sealer recalibration and maintenance service, scheduled by the machine itself. minirò H-net VP pressure control

6 Medical H 460 / H 610 The well known Medical series, which was Gandus Saldatrici s first sealer developed for the medical sealer field, has been updated with the latest Medical H 460 and Medical H 610 models. These impulse sealers combine user friendly and reliability in a design that has evolved over the years. Technical features Medical H 460 / 610 are built in stainless steel with epoxy powder painted steel base chassis. The new control panel placed sideways allows a comfortable easily cleanable working table behind the sealing jaws. Functions The machine has independent adjustment of the sealing and cooling times. Medical H 460 / 610 can be used for pouches in any sealable material: Paper/polypropylene, Tyvek, or polyethylene. Roll holder and Cutting device Medical H 460 / 610 in GT version are supplied equipped with a built-in roll holder and cutting device. Special attention was given to the design of the cutting device, which allows a quick and reliable cutting of reels up to 500mm wide. Medical H 460 with roll holder and cutting device Seal Impulse seal is 8mm wide which conforms to ISO standards. On these latest models the sealing jaws have been increased in length to allow sealing pouches up to 460mm or 610mm wide.

7 Medical H 460 / H 610 Digital AccuTemp The latest design in the popular Medical series is the Digital Accutemp version. This new model reaches the highest performance and control levels for an impulse sealer. These sealers steadily control the three sealing parameters, temperature, pressure and time during the seal cycle in order to guarantee the repeatability of the seal quality. Detail of the command panel Control of the sealing parameters Digital Accutemp system is a very accurate and sophisticated control system. During every sealing cycle the system monitors up to 60 times per second the three sealing parameters: temperature, pressure and time. In the event of any change from the values set by the operator and manufacturer, the machine will activate an alarm and immediately stop. Remote Management Software Functions Many functions are available on these versions: sealing times, temperature which automatically controls the cool cycle, sealing wire auto-calibration, counter setting and the multi-language menu. Interfaces Medical H 460 / 610 Digital Accutemp can be connected to a personal computer and/or to a datalogger printer. Data recording Remote Management Software for Digital Accutemp allows setting of the sealer through a computer, connected by a Com Port. The same software allows the recording of the machine functioning data, in order to guarantee the traceability of the sealing parameters according to the pouch and.or the working time of the sealer. Thanks to this connection you can download the functioning data of the sealing parameters (time, pressure and temperature). These records can then be stored on a PC and managed in Excel. The software can also create charts, which can be stored or printed to be kept as documents of process validation. Maintenance and Service All machines are supplied with a Test and Conformity Certificate. Gandus Saldatrici offers a periodical recalibration and maintenance service. Datalogger Datalogger is an external printer, which can be connected to the Medical Digital Accutemp. The printer records the trend of the sealing parameters and prints them on data sheet, which can be stored.

8 Command panel with digital display minirò H-data minirò H-data data is one of the latest developments of sealing machine to seal and print medical pouches conforming to the ISO11607 standard. Quick and reliable, it is easy to program the many functions available. This machine is equipped with a built-in dot matrix printer to print dates, codes and batches on the pouches as required by the latest traceability standards. Technical features minirò H-data has been designed to be used in sterilization central units where large volume production is required. It is equally at home in small hospital units or operation rooms. Built from epoxy coated steel with a 304 stainless steel cover, it seals at 10 metres/minute, the LC display has 2 lines with 16 characters and the operator interface is via a membrane keypad. Seal Multi-line seal 12mm wide, with temperature adjustment tolerance of +or- 1%, to fully satisfy ISO requirements. The sealer is also equipped with an alarm, which will immediately stop the machine if the temperature is 5 over or under the desired value. Functions The control software in the minirò H-data gives easy user friendly access to a wide range of functions. Through the multi-language menu it is possible to set the temperature, the time and the calendar, the date format and the expiry period. Furthermore, the software manages two settable counters. Printing minirò H-data is equipped with a dot matrix printer to print on the pouch the sterilization and expiry dates, as well as the batch or the operator code. It is possible to choose among different printing sizes, settable by the operator. Complete text can be printed by using the EN980 symbols. Maintenance and Service All machines are supplied with a Test and Conformity Certificate. Gandus Saldatrici offers a periodical recalibration and maintenance service.

9 minirò H-seal Although the minirò H-seal is the basic model in the Gandus range of medical rotary sealers, it has many features. This model has been designed to be used in hospitals and in the medical industry. minirò H- seal is used for continuous production with good seal quality. Technical features Infeed speed 10 mt/min. minirò H-seal is finished in epoxy painted steel with a top cover made in AISI 304 stainless steel. The user friendly keypad and two line display are mounted flush in the top cover to allow easy cleaning of the sealer. Functions Through the minirò H-seal menu the required sealing temperature can be set. A counter is also available in the menu, this will keep its memory even when the sealer is switched off. The software also manages the machine diagnostics and will display warnings for main board, sensor faults or loss of data. Seal Multi-line seal 12 mm wide, free edge 0-30 mm. Seal quality is maintained by a temperature control tolerance ± 1%, of set point to satisfy ISO requirements. Sealer is equipped with alarm which immediately stops the machine if temperature varies by more than ± 5 from set value. Command panel with digital display Maintenance and Service All machines are supplied with a Test and Conformity Certificate. Gandus Saldatrici offers a periodical recalibration and maintenance service.

10 REBI Among Gandus medical sealers, REBI is the most compact model, with its small dimensions and high performance. REBI represents the ideal solution for those users who have limited space and budget. To improve ease of operation the REBI is supplied complete with a front pack support tray. Technical features Speed of sealer is 6metre/minute. Although small dimensions, the REBI has a high capacity throughput. The body is epoxy coated and finished in two colours. Functions The REBI boasts an LC display temperature controller, normally seen on more expensive models. REBI also has the energy saving feature associated with higher specification sealers. If there is a delay of 10 seconds or more between pouches being presented to the sealer, the motor drive stops, REBI starts automatically when the next pouch is put into the sealer. Seal Temperature control panel Multi-line seal 12mm wide. Seal quality is maintained by a temperature control tolerance ± 1%, of set point to satisfy ISO requirements. Sealer is equipped with alarm which immediately stops the machine if temperature varies by more than ± 5 from set value. Printing REBI is also available in REBI PRT version, equipped with integrated 9 dots printer, with ink cartrige, for printing of sterilization and expiration dates, with Clear and EN symbols. Maintenance and Service All machines are supplied with a Test and Conformity Certificate. Gandus Saldatrici offers a periodical recalibration and maintenance service.

11 DN 350 Impulse sealer for medical pouches, DN 350 is designed to be used in small analysis or medical laboratories. Operation The sealing jaws are closed by light hand pressure, electromagnet holds jaw closed for heat and cool cycle, then releases automatically at the end of the cycle (no waiting for audible sounds or indicators) Safety Heat and cool times are set by the operator and adjusted by an electronic timer. The temperature control through a NTC probe allows the repeatability and quality of the seals. The alarm and stop electronic protection in case of any faults or over working avoids the overheating and extend the sealing wires life. Maintenance and Service All machines are supplied with a Test and Conformity Certificate. Gandus Saldatrici offers a periodical recalibration and maintenance service.

12 GD 300 GD 300 is the smallest Gandus medical sealer, extremely reliable and user friendly, highly appreciated for its strong structure and the completeness of the project. Saving and Reliability GD 300 is a machine of small dimensions, especially suitable for dentists, doctors and veterinary surgeons laboratories. Sealing bar is mm 300, manual actioning through built-in lever and sealing time electronic control. Constant heat seal thanks to a thermocontrolled heating element, which keeps the temperature fixed. The sealing system needs no consumables, allowing high costs saving in terms of maintenance. The design of the machine has been projected on a vertical development, with incorporated roll holder. The machine can be positioned also on limited depth tables.

13 Technical features Roll dispenser for medical pouches, knife cuts in both directions, PR-H50 can be mounted on a wall or placed on a working table close to the sealing machine. Dispenser is useful where different lengths of pouch are required without the need of scissors or any other cutting tool. Made in stainless steel AISI 304 and anodized aluminum. PR-H50 Technical Data Max. Cut length 510 mm Bidirection knife Autosafe 4 cutting side-blade Dimensions 630 x 280 x 360 mm Weight 8,5 Kg UC 3001 Workstation mounted on a stand with castors to prepare pouches to be sterilized. Built in stainelss steel AISI 304. Composed by 1 flat working top, tickness 15/10 and upper structure with 2 shelves. Tubular stainless steel carrying structure 40 x 40. Lower flat shelf. Mounted on 4 antistatic rubber castors diameter 80 mm Support in chromate steel complete with brake and directional block. Scotch brite finishing. Work station dimensions: mm 2100 x 800 x h Available in version with adjustable height, with tubular stainless steel carrying structure with 2 pistons for the back-elevation of the top from mm 754 to mm 954. Dimensions: mm 2100 x 800 x 754/ h Accessories on demand Table lamp with magnifying lens Basket in stainless steel mm 580 x 280 x 135h Basket in stainless steel mm 210 x 350 x 200h Drawer mm 500 x 600 x 850h Cutting device mm 1200 Roll dispenser support model N. Group of 3 Schuko plugs Hold monitor support

14 Impulse sealer Constant heated sealer Rotary sealer Stainless steel construction Epoxy painted steel construction Built-in roll holder and cutting device Power Supply 230 V 50/60 Hz Power Supply 115 V 50/60 Hz Membrane keyboard Display a 1 line Display a 2 lines Display a 4 lines Sealing width Sealing height Automatic pressure adjustment Flat seal Multi-lines seal Thermo-controlled sealing jaw Digital thermoregulator Microprocessor Adjustable temperature Temperature control tolerance Infeed speed mt/min Electronic times control MODEL GD DN MEDICAL H 460 H 610 * * MEDICAL DIGITAL ACCUTEMP H 460 H 610 * * % 1% REBI 12 1% 6 REBI PRT 12 1% 6 minirò H-seal 12 1% 10 minirò H-data 12 1% 10 minirò H-net 15 1% 10 minirò H-net VP 15 1% 10 * GT version

15 Temperature control Speed control Pressure control Setting through keyboard Menu access password Time and calendar setting Sterilization and expiry dates setting Text memory Operators memory Counters Multi-language menu Scheduled maintenance Built-in printer Dates printing Text printing Printing of EC and EN 980 symbols Sealing parameters printing Label printing Temperature alarm Speed alarm Pressure alarm Time alarm Fault diagnostics alarm Connectable to PC IConnectable to Palmtop Connectable to Barcode scanner Connectable to External printer Bar Code Designer Software Remote Management Control Software Gandus Saldatrici srl reserves the right to modify the machines they manufacture without any obligation respect to those previously supplied.

16 Via Milano, 5 Tel Fax Cornaredo (MI) - Italy info@gandus.it