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Summary of Contents for Conroy Qseal-extra
- Page 1 Operator´s Manual CS624 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.
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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 ..................4 1.3 Qseal-extra 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... -
Page 4: Warnings And Cautions
Warning! If any of the components of Qseal-extra are exposed to blood, they must be cleaned with an appropriate disinfectant solution. Warning! The instrument must always be connected to a grounded outlet and with appropriate alternating current mains source, 100-130 or 230V~. - Page 5 State in which the user and/or patient is established. Warning! Qseal-extra is not intended for use in an oxygen rich environment. Warning! Qseal-extra is not intended to be used with flammable anaesthetics and not intended for use in conjunction with flammable agents.
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Page 6: Scope
Powered Tube sealer with handle from Conroy Medical AB. 1.1 Introduction Qseal-extra 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 Operation: Continuous, max 480 seals per hour. Intended purpose: The intended clinical benefit of Qseal-extra 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 8 Table 1: Guidance and Manufacturer’s Declaration – Electromagnetic Emission The CS624 Qseal-extra Battery Powered Bench Top Sealer is intended for use in the electromag- netic environment specified below. The customer or the user of the CS624 Qseal-extra should assure that it is used in such an environment.
- Page 9 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The CS624 Qseal-extra is intended for use in the electromagnetic environment specified below. The customer or the user of the Qseal-extra should assure that it is used in such an environment. Immunity Test...
- Page 10 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The CS624 Qseal-extra is intended for use in the electromagnetic environment specified below. The customer or the user of the Qseal-extra should assure that it is used in such an environment. Immunity Test...
- Page 11 RF communications equipment and the CS624 Qseal-extra The CS624 Qseal-extra is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CS624 Qseal-extra can help prevent electro-magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CS624 Qseal-extra as recom- mended below, according to the maximum output power of the communications equipment.
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Page 12: Front View
Front view Power switch Battery unit Connector for the Coaxiable cable Rear view CS624 Qseal-extra Operator´s manual... -
Page 13: Qseal-Extra Parts And Spare Parts
1.3 Qseal-extra parts and spare parts 1.3.1 Qseal-extra, REF CS624 Qseal-extra comprises the parts listed below: Description Main Hand Coaxial Cable Unit Unit 2.3 m Part No. 624000000 62500000 62500100 Description Mains Mains Adapter Connector Kit Part No. 62460100 64662000... - Page 14 1.3.2 Qseal-extra spare parts (user interchangeable parts) Description Main Hand Coaxial Cable Unit Unit 2.3 m Part No. 962450000 962500000 962500100 Description Mains Mains Adapter Connector Kit Part No. 962460100 964662000 CS624 Qseal-extra Operator´s manual...
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Page 15: Symbols/Markings Description
Class II Battery charger: double insulation during charging. Battery charger UL recognised component for Canada and U.S.A. Symbol for “CATALOGUE NUMBER”. Symbol for “WARNING”. Symbol for “CONSULT USER MANUAL”. Symbol for “CONSULT OPERATOR MANUAL”. Symbol for “SERIAL NUMBER”. CS624 Qseal-extra Operator´s manual... - Page 16 Collect Product separately. Use collection and return systems available to you. Product brought to EU market after August 13 , 2005. 3 LED lights: Green when the power is on, orange during seal, green/red blink when battery empty. Symbol for “MEDICAL DEVICE”. CS624 Qseal-extra Operator´s manual...
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Page 17: Installation
If any parts are missing or if the parts are damaged, report it immediately. Please keep all shipping and packaging materials, as they may be required for later transportation, at least during the warranty time. CS624 Qseal-extra Operator´s manual... -
Page 18: Environmental Requirements
If the LED does not light up check that the battery is correctly inserted and charged. Perform a test seal on an empty or water filled tube to ensure proper operation. Caution! Ensure that all cables are connected before turning the power on. CS624 Qseal-extra Operator´s manual... - Page 19 To remove the battery, press down the locking button and carefully slide the battery out of the device. Caution! Ensure that all parts are connected before turning the power on. Caution! To prevent possible damage to the device or the battery, never drop the bat- tery into the device. CS624 Qseal-extra Operator´s manual...
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Page 20: Functional Description
3.1 Description of Sealing The indication for use of Qseal-extra 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 Front view functions of Main unit, with LED, battery location and one Connector (see the picture below). ❶ Power switch; turns the equipment power on and off. (I=ON/0=OFF) ❷ Connector for the special coaxial cable. ❸ Battery location. Front of Main unit. ❶ ❷ ❸ CS624 Qseal-extra Operator´s manual...
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Page 22: Operating Instructions
This chapter describes the use of the instrument. Warning! RF energy during seal procedure and movement of electrode. Warning! Qseal-extra 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
If you should make two or more seals, they should not be within 1 cm (½”) of each other, otherwise the resulting pressure in the tube may cause micro- scopic cracks and holes in the seals. CS624 Qseal-extra Operator´s manual... -
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
Do not use chemical or abrasive cleaners such as acetone, ammonia or similar. Do not use sharp edged tools for cleaning, which could damage the finish of the units. Caution! Do not allow liquid to flow into the electronic part of the equipment. CS624 Qseal-extra Operator´s manual... -
Page 26: Main Unit
We recommend some sealing tests before resuming use, ensure that the electrode moves smoothly in the hand unit. Caution! Do not dip the units in liquid, as they are not waterproof. Intruding liquid will cause malfunction, tiny arcs and reduce the lifetime use. CS624 Qseal-extra Operator´s manual... -
Page 27: Troubleshooting
LED is fast Time out. Check the seal pattern. flashing red. Trigger released. Check the seal pattern. °C °F The battery is protected with a self-resetting auto fuse against overtemperature (70 /158 and short circuit. CS624 Qseal-extra Operator´s manual... -
Page 28: Head Unit
Coaxial cable broken. Contact your local C.M. representative. Seal lamp flickers. Coaxial cable broken. Change coaxial cable or contact your local C.M. representative. Seal lamp doesn’t Main unit inoperative. Contact your local C.M. representative. light but electrode moves. CS624 Qseal-extra Operator´s manual... -
Page 29: Parts Replacement
6.3 Parts Replacement Battery unit replacement For information see 2.3.2. Coaxial cable replacement Turn off the power switch and disconnect the Coaxial cable from the main unit and hand unit. Replace the coaxial cable with the same type. CS624 Qseal-extra Operator´s manual... -
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: 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 32: Product Disposal
7.3 Product Disposal Product Disposal For Qseal-extra disposal (and accessories) at the end of the calculated life cycle of 7 years, please ensure the following: • Do not dispose Qseal-extra as unsorted municipal waste. • Collect the Qseal-extra separately. -
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 CS624 Qseal-extra Operator´s manual... - Page 36 Operator´s Manual CS624 Battery Powered Tube Sealer with Handle conroymedical.com...
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