Conroy Qseal auto Operator's Manual

Battery powered tube sealer with handle

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Operator´s Manual

CS524 Battery Powered Tube Sealer with Handle

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Page 1 Operator´s Manual CS524 Battery Powered Tube Sealer with Handle...
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 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.
Page 3: Table Of Contents
Warnings and Cautions ........................... 2 1. Scope ................................4 1.1 Introduction ..........................4 1.2 Performance and specifications ..................4 1.3 Qseal-auto parts and spare parts ..................11 1.4 Symbols/markings description ..................13 2. Installation .............................15 2.1 Unpacking and inspection ....................15 2.2 Environmental requirements ...................16 2.3 Installation procedure ......................16 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 Warning! Qseal-auto is not intended for use in an oxygen rich environment. Warning! Qseal-auto 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. Caution!
Page 6: Scope
1. Scope This chapter contains a description and specifications of the Qseal-auto, a Battery Powered Tube sealer with handle from Conroy Medical AB. 1.1 Introduction Qseal-auto 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.
Page 7 Sealing capacity: 1500 seals/charge with PVC tubes up to 6.2 mm (0.24”) outer diameter at 20 °C (68 °F). Sealing time: 1-2 sec., max 5 sec. depending on tubing. Operation: Continuous, max 480 seals per hour. Intended purpose: Intended for sealing tubes and bags in blood component sets. Qseal-auto is intended to be used by trained medical pro- fessionals.
Page 8 The Qseal-auto 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 Table 1: Guidance and Manufacturer’s Declaration – Electromagnetic Emission The CS524 Qseal-auto Battery Powered Bench Top Sealer is intended for use in the electromag- netic environment specified below.
Page 9 Table 2: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The CS524 Qseal-auto is intended for use in the electromagnetic environment specified below. The customer or the user of the Qseal-auto should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance...
Page 10 Table 4: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The CS524 Qseal-auto is intended for use in the electromagnetic environment specified below. The customer or the user of the Qseal-auto should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance...
Page 11 Table 6: Recommended separation distance between portable and mobile RF communications equipment and the CS524 Qseal-auto The CS524 Qseal-auto is intended for use in the electromagnetic environment in which radi- ated RF disturbances are controlled. The customer or the user of the CS524 Qseal-auto can help prevent electro-magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CS524 Qseal-auto as recom- mended below, according to the maximum output power of the communications equipment.
Page 12: Front View
Front view 3-coloured LED Yellow Connector green: power on “Seal” for the yellow: low battery red: error/empty battery Coaxiable cable Rear view Power switch Battery unit CS524 Qseal-auto Operator´s manual...
Page 13: Qseal-Auto Parts And Spare Parts
1.3 Qseal-auto parts and spare parts 1.3.1 Qseal-auto, REF CS524 Qseal-auto comprises the parts listed below: Description Main Hand Coaxial Cable Battery Unit Unit 2.3 m Charger Part No. 52400000 52100000 52182400 52410110 Description Mains Holder Connector Kit for handle Part No.
Page 14 1.3.2 Qseal-auto spare parts (user interchangeable parts) Description Hand Unit Battery Unit Coaxial Cable Holder 2.3 m for handle 952100001 952430000 52182400 8 2100 600 Description Battery Charger Mains Connector Battery Charger with Mains Connector Kit 952410110 952410120 952410100 1.3.3 Accessories Description Re-inforced Coaxial Cable Sealer bench mate...
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. This marking reflects compliance with EN 60601-1 and national standards for USA (ANSI/AAMI ES60601-1:2005) and Canadian (CSA C22.2 No. 60601-1)markets. Class II Battery charger: double insulation during charging. Battery charger UL recognised component for Canada and U.S.A.
Page 16 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 Main unit complete 1 Hand unit complete...
Page 18: Environmental Requirements
2.2 Environmental Requirements To keep the instrument operating at its best, please observe the following: • The instrument should be placed on a flat surface free from dust, solvents and acidic vapor. • Use the instrument in an area free from vibration and with a room temperature of 15 - 35°C (60 - 95°F), and relative humidity 10% - 90%.
Page 19 2.3.2 Battery unit installation and battery charging Connect as following: Connect the charger to the Battery connector. Plug the charger into a main power supply. The charger can be connected to main voltages between 100 and 240 Volts. Fast charge takes about 4 hours. When the charge indication on the charger flashes slowly (trickle charge), the battery is fully charged.
Page 20: Functional Description
3. Functional Description This chapter describes how Qseal-auto 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-auto 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 The Coaxial cable is a special shielded coaxial cable, which transfers the RF-energy, the control signal and the air pressure, between the Main- and the Hand-unit. The Hand unit consists of a tube with cable-connection, Air cylinder, Seal button and indication light which shows orange during sealing.
Page 22: Operating Instructions
4. Operating Instructions This chapter describes the use of the instrument. Warning! RF energy during seal procedure and movement of electrode. Warning! Qseal-auto 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.
Page 23: How To Seal Tubes
❷ ❸ ❶ 4.2 How to Seal Tubes Warning! Do not allow hand unit to come in contact with donor. 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 Hand unit. Check that the tube is placed between the electrodes in the slot.
Page 24: If The Sealer Doesn´t Start
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: Cleaning
5. Cleaning This chapter gives information on the cleaning (procedure, frequency) of the Main and Hand units. The Sealer requires minimal maintenance for efficient operation. Follow the cleaning procedure below. Warning! For your own safety always turn off the power switch and remove the battery unit.
Page 26: Main Unit
5.1 Main 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 Main unit.
Page 27: Troubleshooting
6. Troubleshooting Maintenance performed by the user is limited to changing Main- or hand unit, battery unit, coaxial cable and charger. 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.
Page 28: Head Unit
6.2 Hand Unit Problem Probable cause Recommended action The sealing Wet or dirty electrodes. Dry/clean the electrodes, see chapter 5.2 doesn’t start. No ”click” when you press Change Hand unit. the SEAL-button. No connection. Check coaxial cable connections. Coaxial cable broken. Change coaxial cable.
Page 29: Parts Replacement
6.3 Parts Replacement Battery unit replacement For information see 2.3.2. Coaxial cable replacement 1. Turn off the power switch and disconnect the Coaxial cable from the main unit and hand unit. 2. Replace the coaxial cable with the same type or an equivalent model (see chapter 1.3).
Page 30: 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 31 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 32: Product Disposal
• Do not dispose Qseal-auto as unsorted municipal waste. • Collect the Qseal-auto separately. • Use the collection and return systems available to you. For more information on return, recovery or recycling of Qseal-auto, please contact your local Conroy Medical Sales Office. CS524 Qseal-auto Operator´s manual...
Page 33: 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 CS524 Qseal-auto Operator´s manual...
Page 36 Operator´s Manual CS524 Battery Powered Tube Sealer with Handle conroymedical.com...

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