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Summary of Contents for Conroy Qseal free
- Page 1 Operator´s Manual CS646 Cordless Battery 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-free parts and spare parts ...................13 1.4 Symbols/markings description ..................15 2. Installation .............................17 2.1 Unpacking and inspection ....................17 2.2 Environmental requirements ...................17 2.3 Installation procedure ......................18 3. -
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 5 100-130 or 230V~. Warning! Disconnect the device from power source before performing any mainte- nance and cleaning procedure. Warning! Do not modify this equipment without authorization of Conroy Medical or Conroy Medical authorized representative. Caution!
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Page 6: Scope
1. Scope This chapter contains a description and specifications of the Qseal-free, a Portable Battery sealer from Conroy Medical AB. 1.1 Introduction Qseal-free is a fully automatic system for sealing PVC or EVA 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. -
Page 7: Performance And Specifications
1.2 Performance and Specifications The table below lists the physical specifications. Parameter Value/ Description REF CS646: Qseal-free, a complete sealing system, which includes Battery module, Sealing module, Charging station, Mains adapter, Plug kit and Operator’s manual. Type of PVC tube: Different types and sizes of tubes up to 6.2 mm (0.24”) outer diameter can be sealed due to a sophisticated sensing system, which automatically adapts sealing time. - Page 8 The Qseal-free is used in the same environment as medical equipment (hospitals and blood banks). It must be used by highly qualified personnel. Patent pending. Manufacturer Conroy Medical AB according to MDR: Haesthagsvaegen 14A SE-194 52 Upplands Vaesby SWEDEN CS646 Qseal-free Operator´s manual...
- Page 9 Table 1: Guidance and Manufacturer’s Declaration – Electromagnetic Emission The CS646 Qseal-free Portable Battery Sealer is intended for use in the electromagnetic envi- ronment specified below. The customer or the user of the CS646 Qseal-free 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 CS646 Qseal-free is intended for use in the electromagnetic environment specified below. The customer or the user of the Qseal-free 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 CS646 Qseal-free is intended for use in the electromagnetic environment specified below. The customer or the user of the Qseal-free 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 CS646 Qseal-free The CS646 Qseal-free is intended for use in the electromagnetic environment in which radi- ated RF disturbances are controlled. The customer or the user of the CS646 Qseal-free can help prevent electro-magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CS646 Qseal-free as recom- mended below, according to the maximum output power of the communications equipment.
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Page 13: Battery Module
Sealing module Tube slot Display Release button Front cover Battery module Seal button CS646 Qseal-free Operator´s manual... - Page 14 Single charger station Power indicator Connection point for mains adapter Mains adapter for Plug kit for mains adapter, single charger station singel charger station CS646 Qseal-free Operator´s manual...
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Page 15: Qseal-Free Parts And Spare Parts
1.3 Qseal-free parts and spare parts 1.3.1 Qseal-free, REF CS646 Qseal-free comprises the parts listed below: Description Battery Sealing Single Mains Plug kit for module module charger adapter, mains adapter, station single charger single charger station station 64650000 64600000 64660000 64661900 64662000 List of all cables and maximum lengths of cables, transducers and other accessories... - Page 16 1.3.2 Accessories (order separately) Connection point for mains adapter Power indicators Description Multi charger station Mains adapter Cable kit for mains adapter, multi charger station multi charger station 964661000 964662100 964662200 1.3.3 Qseal-free spare parts (user interchangeable parts) Description Battery Sealing Single Mains...
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Page 17: 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. Class II mains adapter: double insulation during charging. Mains adapter UL recognised component for Canada and U.S.A. Symbol for “CATALOGUE NUMBER”. Symbol for “WARNING”. -
Page 18: Led Indications
Symbol for “TEMPERATURE LIMIT”. Symbol for “RELATIVE HUMIDITY LIMITATIONS”. Symbol for “ATMOSPHERIC PRESSURE LIMITATIONS”. Symbol to indicate information about the battery. 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. -
Page 19: 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 module 1 Battery module... -
Page 20: Installation Procedure
2.3 Installation Procedure Preparing the sealer for use Fit correct mains input plug to the mains adapter. The changeable mains plug is available for European continent, UK, USA/Canada and Australia/New Zealand and as IEC standard 320 C8. Attach the mains adapter to the charge station. Plug the mains adapter into the mains. -
Page 21: Functional Description
3. Functional Description This chapter describes how Qseal-free 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-free 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 22: Description Of Equipment
3.2 Description of Equipment Qseal-free consists of a battery module and a sealing module. Below is a short descrip- tion of each component. The sealing module consists of an RF-generator with intelligent sense control, the mo- bile electrode (which can be removed for cleaning). The sealing module uses a little power between sealing. -
Page 23: Operating Instructions
4. Operating Instructions This chapter describes the use of the instrument. Caution! Inspect all parts of the instrument for defects before use. Check sealing pat- tern if sealing module, battery module or complete sealer is dropped. Caution! Always check the seals when the battery capacity is low (1 indicator bar or less). -
Page 24: How To Seal Tubes
Caution! In case of sealer malfunction (intermittent operation, poor seal quality, the sea- ling time seems too long or too short) contact your local Conroy Medical representative for assistance. Caution! Periodically check the pattern of the sealing visually (see picture below). -
Page 25: 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 26: Cleaning
5. Cleaning This chapter gives information on the cleaning (procedure, frequency) of the bat- tery module and sealing module. The sealer requires minimal maintenance for efficient operation. Follow the cleaning procedure below. Warning! For you own safety always disconnect the sealing module from the battery module. -
Page 27: Battery Module
5.1 Battery module 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 battery module. -
Page 28: Troubleshooting
6. Troubleshooting Maintenance performed by the user is limited to changing battery module, sealing module, charger station and mains adapter. The following information covers com- mon problems and offers suggested solutions. 6.1 Battery module Problem Probable cause Recommended action Charge level No voltage. -
Page 29: Sealing Module
6.2 Sealing module Problem Probable cause Recommended action The sealing Wet electrodes. Dry the electrodes, see chapter 5.2. doesn’t start. Dirty electrodes. Clean the electrodes, see chapter 5.2 Wet tube. Dry the tube and electrodes, try again. Tiny arcs between the electrodes. Dry the electrodes and try again. - Page 30 Error Indication Table Error Probable cause Recommended action Indication 1 blink Display/ Restart the sealing unit and re-try. If problem remains change Power error. sealing module or contact your local C.M. representative. 2 blink Temperature Wait until blinking stops. Restart the sealing unit and re-try. error.
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Page 31: 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 32: Product Disposal
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 33: Local Sale Office
8. Local Sale Office CS646 Qseal-free Operator´s manual... -
Page 34: 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... - Page 36 Operator´s Manual CS646 Cordless Battery Sealer conroymedical.com...
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