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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 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.
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! 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!
1. Scope This chapter contains a description and specifications of the Tubestrip, a Portable Automatic Tube Stripper from Conroy Medical AB. 1.1 Introduction Tubestrip is a fully automatic system for stripping PVC or EVA tubes, especially for tubes in blood pack systems. Following the procedure the tube is emptied of its content, 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 CS109: Tubestrip, a complete tube stripping system, which includes Battery module, Tube Stripping 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 used.
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During use: Internal power supply. The Tubestrip 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 CS109 Tubestrip Automatic Tube Stripper is intended for use in the electromagnetic envi- ronment specified below. The customer or the user of the CS109 Tubestrip should assure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment - Guidance...
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Table 2: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The CS109 Tubestrip is intended for use in the electromagnetic environment specified below. The customer or the user of the Tubestrip should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance...
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Single charger station Power indicator Connection point for mains adapter Mains adapter for Plug kit for mains adapter, single charger station single charger station CS109 Tubestrip Operator´s manual...
1.3 Tubestrip parts and spare parts 1.3.1 Tubestrip, REF CS109 Tubestrip comprises the parts listed below: Description Battery Tube Single Mains Plug kit for module Stripping charger adapter, mains adapter, module station single charger single charger station station 64650000 10900000 64660000 64661900 64662000...
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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 9646661000 964662100 964662200 1.3.3 Tubestrip spare parts (user interchangeable parts) Description Battery Tube Single Mains...
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”.
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Symbol for “SERIAL NUMBER”. Symbol for “MEDICAL DEVICE”. Symbol for “Handle with care / FRAGILE”. Symbol for “KEEP DRY”. 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 Tube Stripping module 1 Battery module...
2.3 Installation Procedure Preparing the tube stripper 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 easily reachable mains socket outlet.
3. Functional Description This chapter describes how Tubestrip works, where the connectors and the indica- tions are placed on the unit and their functions. 3.1 Description of Tube Stripping The indication for use of Tubestrip is a need for stripping of tubing in blood component sets during blood and plasma donation or other blood component preparation.
3.3 Checking the battery module The battery level indication on the tube stripping module keypad, is in steps of twenty- five percent. The battery can be recharged at any time or at least when prompted by a blinking battery indicator. The tube stripping function will be blocked if attempted when the level is <20%, battery indicator led 1 blinks or switches off.
When the button is released or the rollers stop, stripping is finished. Remove the tubing. Check the tube for leakage. Caution! In case of unit malfunction (intermittent operation, poor performance quality) contact your local Conroy Medical representative for assistance. CS109 Tubestrip Operator´s manual...
4.3 If the Tube Stripper Doesn´t Start The Tube Stripper has several safety functions. Before tube stripping, these functions con- trol and identify whether it is possible to strip the tube. The table below covers the com- mon 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 bat- tery module and tube stripping module. The unit requires minimal maintenance for efficient operation. Follow the cleaning procedure below. Warning! For you own safety always disconnect the tube stripping module from the 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.
6. Troubleshooting Maintenance performed by the user is limited to changing battery module, tube stripping module, charger station and mains adapter. The following information covers common problems and offers suggested solutions. 6.1 Battery module Problem Probable cause Recommended action Charge level No voltage.
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Error Indication Table Error Indication Probable cause Recommended action 1 blink Keypad/ Restart the tube stripping module and re-try. If problem re- Power error. mains change tube stripping module or contact your local C.M. representative. 2 blink Temperature Wait until blinking stops. Restart the tube stripping module error.
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 Tubestrip separately. • Use the collection and return systems available to you. For more information on return, recovery or recycling of Tubestrip, please contact your local Conroy Medical representative. 8. Local Sale Office CS109 Tubestrip 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 CS109 Tubestrip Operator´s manual...
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