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Operator´s Manual CS529 Bench Top Sealer for Heavy-Duty Use...
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Every effort has been made to ensure that the information in this document is correct, but we make no guarantee to this effect and would appreciate any observations regard- ing the contents of this document. We may make improvements and alterations to the instrument and these changes will be incorporated in new issues of this publication when practicable.
Warnings and Cautions The general safety information in the manual is for operating personnel. Specific notes, cautions and warnings are found throughout the manual where applicable. Please read the Operator’s manual carefully before use. Note! Identifies conditions that should be noted carefully. Caution! Identifies conditions that could result in damage to the equipment.
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Warning! Qseal-opti is not intended to be used with flammable anaesthetics and not intended for use in conjunction with flammable agents. Warning! Do not modify this equipment without authorization of Conroy Medical or Conroy Medical authorized representative. Warning! Qseal-opti is not intended for use in an oxygen rich environment.
1. Scope This chapter contains a description and specifications of the Qseal-opti, a Bench top sealer from Conroy Medical AB. 1.1 Introduction Qseal-opti is a fully automatic system for sealing PVC tubes, especially for tubes in blood pack systems. Following the sealing procedure the tube is easily pulled apart, due to the distinct sealing pattern, with no damage to the blood inside the tubes.
1.2 Performance and Specifications The table below lists the physical specifications. Parameter Value/ Description REF CS529: Qseal-opti, a complete sealing system, which includes Main unit, built-in Head unit, Power cord and Operator’s manual. Type of PVC tube: Different types and sizes of tubes up to 6.2 mm outer diameter can be sealed due to a sophisticated sensing system, which automatically adapts sealing time.
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Electrical safety: Class I The Qseal-opti is used in the same environment as medical equipment (hospitals and blood banks). It must be used by highly qualified personnel. Manufacturer Conroy Medical AB according to MDR: Haesthagsvaegen 14A SE-194 52 Upplands Vaesby SWEDEN...
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Table 1: Guidance and Manufacturer’s Declaration – Electromagnetic Emission The CS529 Qseal-opti Bench Top Sealer is intended for use in the electromagnetic environment specified below. The customer or the user of the CS529 Qseal-opti should assure that it is used in such an environment.
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Table 2: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The CS529 Qseal-opti is intended for use in the electromagnetic environment specified below. The customer or the user of the Qseal-opti should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance...
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Table 4: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The CS529 Qseal-opti is intended for use in the electromagnetic environment specified below. The customer or the user of the Qseal-opti should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance...
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Table 6: Recommended separation distance between portable and mobile RF communications equipment and the CS529 Qseal-opti The CS529 Qseal-opti is intended for use in the electromagnetic environment in which radi- ated RF disturbances are controlled. The customer or the user of the CS529 Qseal-opti can help prevent electro-magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CS529 Qseal-opti as recom- mended below, according to the maximum output power of the communications equipment.
Front view 2 coloured LED indicator “Seal” LED indicator Slot with start switch Front electrode Head unit Release button for front electrode Rear view Power switch Power receptacle Carrying rod Release grip Type label for Head unit CS529 Qseal-opti Operator´s manual...
1.3 Qseal-opti parts and spare parts 1.3.1 Qseal-opti, REF CS529 Qseal-opti comprises the parts listed below: Description Main unit Head unit Power cord, 2.5 m Part No. 52900000 52930000 820 981 00 Order separate power cord for: Description Australia 8 7901 1252 8 7901 1253 8 7901 1254 List of all cables and maximum lengths of cables, transducers and other accessories...
1.4 Symbols/Markings Description On instrument and labels: Symbol for “MEDICAL DEVICE”. This marking reflects compliance with the Council Directive 93/42/EEC on Medical Devices. Symbol for “CATALOGUE NUMBER”. Symbol for “WARNING”. Symbol for “CONSULT OPERATOR MANUAL”. Symbol for “SERIAL NUMBER”. Symbol for “DATE OF MANUFACTURE”. Symbol for ”MANUFACTURER”.
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Symbol for “KEEP DRY”. Symbol for “HANDLE WITH CARE / FRAGILE”. Symbol for “ATMOSPHERIC PRESSURE LIMITATIONS”. Symbol for “NON-IONIZING RADIATION”. Symbol (WEEE 2002/96/EC) - Do not dispose Product as municipal waste. Collect Product separately. Use collection and return systems available to you. Product brought to EU market after August 13 , 2005.
2. Installation This chapter involves unpacking, temperature requirements and installation of the instrument. 2.1 Unpacking and Inspection Visually inspect the cardboard box for damage. Report any damage immediately. Lift the instrument out of the cardboard box and place it on a flat surface. The instrument is shipped in one cardboard box that includes: 1 Main unit 1 Power cord...
2.3 Installation Procedure Preparing the sealer for use Connect the power cord to the receptacle at the rear of the Main unit. Plug the power cord into a grounded outlet. Perform a test seal on an empty or water filled tube to ensure proper operation. Note! The instrument has an automatic auto range sensor, which means that it changes automatically to the correct main voltage 115 or 230 V ~.
3. Functional Description This chapter describes how Qseal-opti works, where the connectors and the indica- tions are placed on the unit and their functions. 3.1 Description of Sealing The indication for use of Qseal-opti is a need for seal and separation of tubing or bags in blood component sets during blood and plasma donation or other blood component preparation.
3.2 Description of Equipment Qseal-opti consists of a Main unit with built-in Head unit. Below is a short description of each component. The Main unit consists of the following modules: • Power entry module, mains filter, and separate on/off switch. •...
4. Operating Instructions This chapter describes the use of the instrument. Caution! Inspect all parts of the instrument for defects before use. Warning! Qseal-opti uses radio frequency (RF) energy to generate heat for sealing. Users should be cautious of potential electrical shocks or hazards while handling this sealer.
4.2 How to Seal Tubes Note! The tube must be dry on the outside. Put the tube to be sealed down to the bottom of the slot ❶ of the Head unit. Gently press the tube down to hit the start switch and to start the sealing process.
4.3 If the Sealer Doesn´t Start The Sealer has several safety functions. Before sealing, these functions control and iden- tify whether it is possible to seal the tube. The table below covers the common probable causes for problems and suggests some recommended actions. Probable cause Recommended action Wet tube...
5. Cleaning This chapter gives information on the cleaning (procedure, frequency) of the Main and Head units. The Sealer requires minimal maintenance for efficient operation. Follow the cleaning procedure below. Warning! For you own safety always turn off the power switch and disconnect the Power Cord.
5.1 Main Unit Cleaning may be required as a result of spilled drops of blood or once per week. If spillage occurs, the unit must immediately be removed from service and cleaned com- pletely before resuming use. Use a soft lint-free tissue, moistened with a mild detergent to clean the outside of the Main unit.
6. Troubleshooting Maintenance performed by the user is limited to changing Head unit and power cable. The following information covers common problems and offers suggested solutions. 6.1 Main Unit Problem Probable cause Recommended action LED doesn’t light No Voltage. Check power supply. up green.
6.3 Parts Replacement Power cord replacement • Turn the power switch off and disconnect the power cord. • Replace the power cord with the same or an equivalent model (see Section 1.3). Head unit replacement • Turn the power switch off and disconnect the power cord. •...
7. Warranty and Service Information on the warranty and the service provided by Conroy Medical is listed below: 7.1 Warranty Conroy Medical guarantees that the equipment shall be free from defects in material and workmanship when delivered to the original purchaser. Conroy Medical´s sole ob- ligation shall be limited to repair or replacement, at Conroy Medical´s option and ex-...
A brief written description of the problem should be attached to the instrument when it is returned for service. Conroy Medical will not be responsible for unauthorized returns or for units damaged in shipment due to improper packing.
• Collect the Qseal-opti separately. • Use the collection and return systems available to you. For more information on return, recovery or recycling of Qseal-opti, please contact your local Conroy Medical Sales Office. 8. Local Sale Office CS529 Qseal-opti Operator´s manual...
Regulation (EU) MDR 2017/745 for medical device and Directive 2011/65/EU (RoHS). This declaration is supported by the quality system approval to ISO 13485 issued by Intertek IMNB. This declaration of conformity is issued under the sole responsibility of Conroy Medical AB. Upplands Vaesby, 2024-10-07 Place and date Nicklas Lundman, CEO CS529 Qseal-opti Operator´s manual...
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Operator´s Manual CS529 Bench Top Sealer for Heavy-Duty Use conroymedical.com...
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