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Summary of Contents for Conroy Qseal multi
- Page 1 Operator´s Manual CS629 Bench Top Sealer...
- Page 2 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 regar- ding 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.
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Page 3: Table Of Contents
Warnings and Cautions ............................2 1. Scope ..................................4 1.1 Introduction ............................4 1.2 Performance and specifications ....................5 1.3 Qseal-multi parts and spare parts ...................12 1.4 Symbols/markings description ....................13 2. Installation ................................15 2.1 Unpacking and inspection ......................15 2.2 Environmental requirements .....................15 2.3 Installation procedure ........................16 2.3.1 Stand Alone............................ -
Page 4: Warnings And Cautions
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. - Page 5 Warning! The instrument must always be connected to a grounded outlet and with appropriate alternating current mains source, 100 or 240 V ~. Warning! Do not modify this equipment without authorization of Conroy Medical or Conroy Medical authorized representative. Warning! Qseal-multi is not intended for use in an oxygen rich environment.
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Page 6: Scope
1. Scope This chapter contains a description and specifications of the Qseal-multi, a Bench top sealer from Conroy Medical AB. 1.1 Introduction The intended clinical benefit of Qseal-multi is safe sealing of tubes and bags. Intact seals minimize the risk for contamination and discards of blood component and provide safety for the user and patient. -
Page 7: Performance And Specifications
Max. 1000 seals/hour with PVC tubes up to 5 mm outer diameter (wall thickness 0,56 mm) at 20°C (68°F). For information concerning EVA tubes, contact your local Conroy Medical representative. Sealing time: 0.6 up to 3 sec. depending on tubing. - Page 8 Class I The Qseal-multi 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 CS629 Qseal-multi Operator´s manual...
- Page 9 Table 1: Guidance and Manufacturer’s Declaration – Electromagnetic Emission The CS629 Qseal-multi Bench Top Sealer is intended for use in the electromagnetic environ- ment specified below. The customer or the user of the CS629 Qseal-multi should assure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment - Guidance...
- Page 10 Table 2: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The CS629 Qseal-multi is intended for use in the electromagnetic environment specified below. The customer or the user of the Qseal-multi should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance...
- Page 11 Table 4: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The CS629 Qseal-multi is intended for use in the electromagnetic environment specified below. The customer or the user of the Qseal-multi should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance...
- Page 12 Table 6: Recommended separation distance between portable and mobile RF communications equipment and the CS629 Qseal-multi The CS629 Qseal-multi is intended for use in the electromagnetic environment in which radi- ated RF disturbances are controlled. The customer or the user of the CS629 Qseal-multi can help prevent electro-magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CS629 Qseal-multi as recom- mended below, according to the maximum output power of the communications equipment.
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Page 13: Front View
Front view 3 coloured LED display Optic sensor Sealing module Front cover with tube slot Rear view Type label USB connector Power switch Main inlet CS629 Qseal-multi Operator´s manual... -
Page 14: Qseal-Multi Parts And Spare Parts
1.3 Qseal-multi parts and spare parts 1.3.1 Qseal-multi, REF CS629 Qseal-multi comprises the parts listed below: Description Sealing unit Power cord, 2.5 m Part No. 64900000 82098100 Power cord available for the following countries, order separately: Description USA/Japan Australia/NZ 879011252 879011253 879011254 List of all cables and maximum lengths of cables, transducers and other accessories... -
Page 15: Symbols/Markings Description
1.4 Symbols/Markings Description On instrument and labels: This marking reflects compliance with the Council Directive 93/42/EEC on Medical Devices. Symbol for “CATALOGUE NUMBER”. Symbol for “CONSULT USER MANUAL”. Symbol for “WARNING”. Symbol for “CONSULT OPERATOR MANUAL”. Symbol for “SERIAL NUMBER”. Symbol for “DATE OF MANUFACTURE”. -
Page 16: Led Indications
Symbol for “TEMPERATURE LIMIT”. Symbol for “RELATIVE HUMIDITY LIMITATIONS”. Symbol for “ATMOSPHERIC PRESSURE LIMITATIONS”. Symbol for “KEEP DRY”. Symbol for “HANDLE WITH CARE / FRAGILE”. Symbol for ”NON-IONIZING RADIATION”. Symbol (WEEE 2002/96/EC) - Do not dispose Product as municipal waste. Collect Product separately. -
Page 17: Installation
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 Sealing unit 1 Power cord... -
Page 18: Installation Procedure
2.3 Installation Procedure 2.3.1 Stand alone Preparing the sealer for use Connect the power cord to the receptacle at the rear of the Sealing unit. Plug the power cord into a grounded outlet. Perform a test seal on an empty or water filled tube to ensure proper operation. 2.3.2 Multi set-up Ensure rails positioning and number of units dependent on the number of seg- ments required. -
Page 19: Programming För Single Or Multi Use
2.3.3 Programming for Single or Multi Use All units should be turned off and front covers removed. 2.3.3.1 Programming for Multi Use Programming Master: Cover the optic sensor and turn on the unit. Wait until the red error LED stops blinking and the unit goes to Master mode by lighting 1 yellow and 1 green LED. -
Page 20: Functional Description
3. Functional Description This chapter describes how Qseal-multi works, where the connectors and the indi- cations are placed on the unit and their functions. 3.1 Description of Sealing The indication for use of Qseal-multi 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. -
Page 21: Operating Instructions
4. Operating Instructions This chapter describes the use of the instrument. Warning! Qseal-multi uses radio frequency (RF) energy to generate heat for sealing. Users should be cautious of potential electrical shocks or hazards while hand- ling this sealer. Always keep your fingers away from the electrodes in the slot. Never place any object other than the PVC tube between the electrodes. - Page 22 The tube activates the sealing process. The sealing electrodes press the tube to- gether and the “Seal Indicator” on the Sealing unit lights up. The sealing time is normally 0.5 to 3 seconds. Avoid stretching the tube during the sealing process. Note! Keep the tube in position until the light goes out.
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Page 23: If The Sealer Doesn´t Start
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... -
Page 24: Cleaning
5. Cleaning This chapter gives information on the cleaning (procedure, frequency) for the Sea- ling unit. 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. -
Page 25: Sealing Unit
5.1 Sealing Unit Cleaning may be required as a result of spilled drops of blood or when required after inspection. 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 Sealing head and cover. -
Page 26: Troubleshooting
6. Troubleshooting Maintenance performed by the user is limited to changing main unit and power cord. The following information covers common problems and offers suggested solutions. 6.1 Main Unit Problem Probable cause Recommended action Power on indica- No Voltage. Check power supply. tor doesn’t light Check that main switch is on. -
Page 27: Warranty And Service
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-... -
Page 28: Service
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. -
Page 29: Product Disposal
• Collect the Qseal-multi separately. • Use the collection and return systems available to you. For more information on return, recovery or recycling of Qseal-multi, please contact your local Conroy Medical Sales Office. 8. Local Sale Office CS629 Qseal-multi Operator´s manual... -
Page 30: Eu Declaration Of Conformity
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 CS629 Qseal-multi Operator´s manual... - Page 32 Operator´s Manual CS629 Bench Top Sealer conroymedical.com...
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