User manual (English) - Quickels® Systems AB
Contents
1. USER MANUAL 14 DECAPUS III Service and maintenance DAILY PREVENTIVE MAINTENANCE Inspect the condition of the equipment daily and check e Check that the Quickels electrodes have been changed and the filters are not full e Check signal modules patient cables recorder cable and power supply for visible damage e g worn insulation defective contacts etc e Replace cables if needed e Check that the recorder cable is properly connected to the ECG printer e Check that the arm and table fixation are properly fixed e Check for any cracks or defects that might make it possible to get into the internal electronics areas unintentionally CLEANING Cleaning should be done as needed or in accordance Authorisation to perform with a schedule P service and maintenance Disconnect the system from the mains supply by Servicing may only be performed by withdrawing the plug from the mains socket qualified personnel e Clean the plastic casings of the system and the patient cables with a cloth moistened with a solution N of mild detergent and water Caution e Thoroughly wipe the unit dry after cleaning with a Decapus Ill must not be sterilised clean soft cloth or paper towel or immersed in fluids Neither should n l l l fluids be allowed to be sucked e f needed disinfect with a cloth moistened with through the system surface disinfectant disinfecting agent with ethanol 702. SIGNAL MODULE Signal module with filter that absorbs 1 5 ml of fluid QUICKELS ELECTRODES Q The easily replaceable Quickels electrodes contain a primary filter that can absorb 1 ml of fluid and prevents fluid borne contamination from entering the system The electrode itself is coated with silver silver chloride for high signal quality ARM Q The easily adjustable arm supports the patient module and simplifies patient movement from rest to stress position Arm movements are adjusted using the three friction screws POWER SUPPLY O Connects to an earthed mains supply Pump fastening other arm fastenings and ECG adapters for ECG printers are available as accessories Patient module The parts The patient module consists of a control panel control electronics and a defibrillation protector The control panel has touch buttons and is easy to use and clean Q Indicator for electrode change after 10 measurements Button for acknowledgement of replacement 4 4 buttons for setting desired negative pressure On off button to shut off the vacuum pump to loosen electrodes after measurement Battery operation and charging status indicator l Sna abc DP I Mains power indicator Q c lt s c c c c Marking panel for leads Service needed indicator Contact authorised service technician USER MANUAL DECAPUS III
3. The system s 10 Quickels electrodes must be replaced at the same time then press the acknowledgement button after changing them USER MANUAL DECAPUS III How to use Decapus III 1 PERFORMING SAFETY CHECKS Check that there is no visible sign of damage on the system Ensure that the safety requirements in the section mportant safety information have been complied with Ensure that the system is connected to ECG equipment according to the section Important safety information Decapus Ill must not be used for ECG recordings for longer than 40 minutes at a time Operator ECG system for a stress test 2 PREPARING THE SYSTEM Check that there are Quickels electrodes on all signal modules v Adjust the position of the arm so that the patient module comes close to the patient The vacuum pump starts when you select the appropriate vacuum level with buttons 1 4 on the patient module For good ECG recording the patient must be able to lie completely relaxed Arms and legs must not touch any other objects in the room Reduce the antenna effect by gathering the cables together Example of how to place the 12 3 PERFORMING MEASUREMENTS Moisten the area thoroughly where the electrodes are to be attached using a dressing with salt solution or spray on a salt solution Never spray the Quickels electrodes or signal modules directly The filter would become full of fluid and
4. connection the vacuum pump starts when the vacuum level is selected with buttons 1 4 on the control panel If the vacuum pump is left turned on during battery operation it will shut down automatically after one hour Battery operation option means that Decapus III can function as a completely mobile system Battery charging occurs automatically when the system is connected to the mains and the vacuum function is off The life time is around 400 charging cycles The battery charging time is about 2 hours and the runtime is about 3 5 hours which corresponds In the event of battery failure the a approximately to service light on the patient module e 50 resting ECGs 5 min per round lights up contact an authorised V e 10 ECG stress tests 20 min per round service technician 11 Signal modules Signal module and electrodes Fit each of the signal modules to the patient cable with the a corresponding marking Ensure that the patient cable is properly connected to the signal module with a tight fit and not being loose e os OSG d Electrodes should be replaced after every 10 measurements which is indicated by a diode on the front of the patient module All 10 electrodes in the system must be changed at the same time The N acknowledgement button on the All 10 electrodes are replaced at the control panel of the patient module same time should then be pressed in
5. 80 propanol 70 80 or aldehyde 2 4 Z N e Wipe dry afterwards Annual maintenance If the hospital or institution does not have an acceptable schedule for cleaning and inspection of this appa ratus this may result in failure of the apparatus and health risks Annual maintenance must be performed by qualified personnel EU Declaration of Contormity We QUICKELS SYSTEMS AB BJORNNASVAGEN 21 SE 114 19 STOCKHOLM SWEDEN TELEPHONE 46 8 709 49 00 FAX 46 8 709 00 12 E MAIL INFO QUICKELS COM declare that the product below conform to applicable requirements in the Swedish Medical Products Agency s regulations on technical medical products LVFS 2003 11 The products thereby also conform to the requirements of Directive 93 42 EEC MDD Medical Device Directive and conform to the standards for electromedical equipment safety IEC 60 601 1 1988 and A1 A2 IEC 60 601 2 25 1993 and A1 Also with Biocompatibility In vitro cytotoxicity ISO 10993 5 Skin irritation ISO 10993 10 Allergy ISO 10993 10 The product also fulfil the applicable requirements of the European Parliament and Council s Directives 2011 65 EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment RoHSII and 2012 19 EU on waste comprising or containing electrical or electronic products WEEE Type Vacuum application of ECG electrodes Product class MDD Class lla GMDN 36369 Name Decapus Ill Ca
6. once per day and at least after every tenth patient to maintain the system s function and lifetime When Decapus Ill is equipped with a lithium ion li ion battery this must not be thrown away when reached the end of their useful life but sent for recycling DEFIBRILLATION PROTECTION The symbol on the back of the patient module means that Decapus Ill has built in protection against defibrillation voltages and that the system has been tested and approved for use in connection with defibrillation The system has been designed so that it cannot be damaged even if the defibrillator electrodes come into contact with the Quickels electrodes During defibrillation never touch the patient or any other conductive item that is in contact with the patient EXPLOSION RISK Decapus Ill is not designed for use in locations where there is an explosion risk FIRE AND EXPLOSION HAZARD Decapus Ill contains a li ion battery as an option Only replace the battery with the type specified WARNING You must read the user manual before using the system Conductive parts of patient cables Quickels electrodes and signal modules including the neutral leads and the electrode must not come into contact with other conductive parts including earth protection The USB input must only be connected when Decapus Ill is being serviced i e never when the system is near or connected to a patient CURRENT LEAKAGE The patient module cables are ga
7. salt bridges would be created Fasten the Quickels electrodes to the patient by gently pressing the top of the signal module this opens the valve in the signal module creating negative pressure Ma If necessary adjust the pressure level to reduce the risk of suction marks 13 How to use Decapus lll contd Only salt solution should be used Otherwise there is a risk of skin damage A Change electrodes regularly To ensure the apparatus is not damaged the Quickels electrodes must be changed when the filter is full or after every 10 patients A Do not pull the cables They may break 4 AFTER MEASUREMENT Press the on off button on the control panel to release the Quickels electrodes from the patient If no button on the patient module is pressed for an hour the vacuum pumps shuts off automatically If the system is equipped with a battery it must always be connected to the mains when not in use to recharge the battery When the electrode change lamp lights replace the Quickels electrodes and acknowledge this by pressing the button If you choose to use Quickels electrodes for more than one patient wipe them off with a cloth moistened with 70 alcohol between uses Replace the Quickels electrodes at least once per day to maintain signal quality If needed disinfect the signal modules with 70 alcohol or surface disinfectant Wipe dry with a cloth afterwards
8. EC 60 601 1 e Decapus Ill must not be connected to ECG apparatus of Safety Classification B according to IEC 60 601 1 SYSTEM CONSTRUCTION Decapus IIl is a system made up of modules What is stated in this User manual about safe use assumes that Decapus III is used in its entirety i e that no part of Decapus Ill is replaced with other equipment The same applies to all the system s cables Decapus IIl is marked with this symbol This is the international warning symbol to indicate that use of the equipment may be dangerous It is therefore important that you read this user manual carefully Before any equipment is used the operator must ensure that there is no sign of damage Take any necessary action if Fluid has been spilled onto the system The cover or casing is split damaged or missing Cables or connectors show signs of damage The system has suffered possible mechanical damage e g fallen on the floor Safety precautions should be taken when ECG measurements are to be taken from patients fitted with a pacemaker or other electric stimulator Important safety information conta Decapus III must only be used as a vacuum applicator for ECG electrodes in the way described in this user manual Quickels Systems AB will not guarantee the equipment s function if it is exposed to higher levels of electromagnetic interference than it has been tested for Quickels electrodes must be replaced at least
9. NNE Oule ers This compensation applies on the condition that Quickels is notified of the stated defects during the guarantee period and as soon as these have been discovered Quickels obligations under this guarantee are also on condition that the buyer of the products accepts i all costs of return carriage to Quickels main premises or another place specifically designated by Quickels or an authorised dealer of representative of Quickels and ii the entire risk of loss during transport It is expressly agreed that Ouickels liability is limited and that Quickels does not act as an insurer In accepting and purchasing a product the buyer confirms and agrees that Quickels is not responsible for loss or damage directly or indirectly caused by any event or consequence of this with regard to the products If Quickels should become liable to anyone under any rule of law other than the express guarantee stated here for loss or damage Quickels liability is limited to the lower of the actual loss or damage or the original purchase price of the product when sold USER MANUAL DECAPUS III Technical data GENERAL ENVIRONMEN TAL REQUIREMENTS PUMP MODULE PATIENT MODULE POWER SUPPLY CABLES PATIENT CABLE QUICKELS ELECTRODE BATTERY SIGNAL IN OUT PUMP MODULE STAND SERVICE APPLICATION Satety Ambient temperature Relative humidity Air pressure Power consumption Negative pressure Airflow Measureme
10. Pump module The parts The pump module includes vacuum pump silencer pulsation dampers pressure sensor and control electronics battery as an option Power supply input Quickels AB Decapus Ill Art QN 4321 S N 987654 Control cable input from patient module Vacuum hose input from patient module USB connection gt Never connect to anything other than the intended Battery status is indicated by four levels on the power sypply control panel gt e Steady green lights in fields 1 4 indicate Only connect with Decapus III patient module the charge level of the battery e Ablinking orange light in the lowest field indicates low battery level After use the system should be connected to an earthed mains socket to recharge the battery gt The USB input must only be connected when Decapus Ill is being serviced i e never when the system is near or adhered to a patient e When battery capacity reaches the minimum level the system shuts off and shows only a blinking orange light if Li ion battery Fire and explosion hazard the operator presses any button on the Never use any other kind of battery control panel e A green blinking light indicates that the battery is charging During charging the steady lights show the battery s level of charge gt The battery may only be replaced by a qualified service technician Battery operation During operation on battery without mains
11. USER MANUAL Decapus Il Contents gt gt Quickels Systems AB Bjornnasvagen 21 SE 114 19 Stockholm SWEDEN Telephone 46 8 709 49 00 Fax 46 8 709 00 12 E mail info quickels com This is Decapus III Important safety information Key to symbols Decapus Ill system design Patient module Pump module Signal module och electrodes How to use Decapus III Service and maintenance EU Declaration of Conformity Statement Guarantee exe hn TT 10 11 12 14 is 16 1 18 verd o This is Decapus Ill a as T riri Decapus IIl is hygienic easy to use and time saving The system has all the advantages that are normally associated with vacuum application but lacks the disadvantages Vacuum ECQ with flow compensated negative pressure prevents the negative pressure from significantly exceeding the level selected on the patient module Double filters efficiently prevent fluid borne contaminants from being sucked into the system and causing an obstruction The easily exchangeable Ouickels electrodes can be replaced as necessary which means that from a hygienic point of view Decapus lll is comparable to adhesive electrodes In special situations the signal modules can easily be replaced with adhesive electrodes UNIOUE SIGNAL MODULE AND FILTER What makes Decapus Ill unique are the patented signal modules and Quickels electrodes Quickels electrodes are easy to attac
12. esponsibility of any kind for errors or omissions that may be found in this document Quickels Systems AB does not undertake to update the information in this document or to maintain its relevance 17 Guarantee Your guarantee from Quickels Systems AB Quickels Systems AB hereinafter called Quickels hereby guarantees Quickels products hereinafter called products from defects in materials and manufacture with normal use service and maintenance during the guarantee period for such products from Quickels or authorised dealers of Quickels representatives Normal use service and maintenance means operation and care in accordance with the respective instructions and or directions This guarantee does not cover damage to products caused by one or more of the following circumstances Damage during carriage b Parts and or accessories for the products that do not come from or are not approved by Ouickels c Incorrect handling incorrect use carelessness and failure to follow instructions and or directions d Accident a disaster that affects the products e Changes or modifications to products without the consent of Quickels f Other circumstances that reasonable lie outside Quickels control or that do not arise during normal operation CD COMPENSATION UNDER THIS GUARANTEE IS LIMITED TO 1 REPAIR OR REPLACEMENT WITHOUT CHARGE FOR WORK OR MATERIALS 2 PRODUCTS THAT ARE CONFIRMED TO BE DEFECTIVE AFTER IDP EN O
13. h to the patient s skin Decapus Ill automatically maintain the chosen negative pressure level even if leakage occurs and air gets in This means that Quickels electrodes stay fastened and give a good contact with little risk of the patient feeling uncomfortable or getting suction marks The primary filter in Quickels electrodes is a super absorbent and can absorb up to 1 ml of fluid The secondary filter which is in the signal module provides further protection and never needs changing Quickels Systems AB s innovations in the Quickels electrodes and signal modules make Decapus III a hygienic and reliable system that seldom needs to be shut off to clean blocked signal modules or patient cables The reinforced patient cables with high tensile strength to ensure good signal quality over long periods The system is defibrillation protected BATTERY OPERATION MEANS FREEDOM Decapus Ill has a battery operation with built in charger as an optional extra which makes it completely mobile The battery is a lithium ion type giving a long operating period 3 5 hours and a fast charging cycle 2 hours USER MANUAL DECAPUS III 4 N NS YN e O O Important safety information SAFETY CLASSIFICATION Decapus III complies with the safety requirements of the International Electrotechnical Commission publication IEC 60 601 1 Safety of Medical Electrical Equipment Safety Classification Group l type CF with defibrillat
14. ins nstruct ons Protection for pen Battery status Catalogue defibrillation 4 levels number voltage Date of Caution Serial number manufacture Warning Batch code tli Manufacturer USER MANUAL DECAPUS III Decapus lll system design Friction hand T l m 4 Printer cable J alt Va on i a Te P ee A rinter Wk ses os fj E FN NS SN IF lj Vacuum hose ET T Control cable e Smm PATIENT MODULE O Decapus Ill is controlled from the control panel on the patient module The control cable and vacuum hose connect the patient module with the pump module B The recorder cable connects to an ECG printer PUMP MODULE Q The pump module includes vacuum pump silencer vacuum and pulsation dampers control electronics and as an option a rechargeable battery PATIENT CABLES 9 The ten shielded interference free patient cables are low friction type and are highly flexible Like the signal modules they are clearly marked with identification complying with IEC standards A connector 4 mm in diameter allows adhesive electrodes to be used Z N The recorder cable must only be connected to MDD 93 42 EEG approved ECG printers of type CF according to IEC 60 601 1 Decapus IIl consists of pump module patient module power supply control cable vacuum hose recorder cable patient cables signal modules Quickels electrodes table fixation and arm
15. ion protection and Classification Group lla in accordance with the Medical Device Directive 93 42 EEC WARNING OF POWERFUL ARM SPRING Check that the fricition screw in the middle of the arm is tight when the arm is unpacked otherwise the arm may spring up In the interests of safety hold the arm together with a firm grip when the tape is removed The arm is locked with a friction screw CONNECTION TO AN EARTHED ELECTRICAL SOCKET The safety classification states that Decapus Ill may only be connected to an earthed socket Note Connection must not be via a multi socket extension to which other electrical equipment that does not have the same safety classification as specified above is connected IMPORTANT INFORMATION ABOUT RADIO TRANSMISSION EQUIPMENT ETC Decapus Ill complies with the EMC requirements of IEC 60 601 1 2 Radio transmission equipment etc must not be used in the vicinity of the apparatus since this could affect its function Special care must be taken when using powerful interference sources such as for diathermy and similar and also ensure that diathermy cables etc are not located on or near the Decapus Ill In case of doubt please consult responsible personnel or the supplier CONNECTION TO ECG PRINTERS AND MONITORS The Decapus III printer cable may only be connected to e ECG printers and monitors that comply with Medical Device Directive 93 42 EEG and are defibrillation protected type CF according to I
16. lvanically insulated from the pump module and from earth guaranteeing that electric current through the patient is kept at a safe level If a Quickels electrode the ECG connector or the patient cables come into contact with other conductors there is a risk of patient shock This applies whether the object is earthed or not No equipment not approved by Quickels Systems AB may be connected or there is a danger of current USER MANUAL DECAPUS III Important safety information conta leakage occurring If other electrical equipment which is not classified according to the above is used in the same premises or in the vicinity of the patient appropriate precautions must be taken CLEANING Cleaning should be made daily e Cleaning should be carried out only with a damp cloth and mild detergent soap solution or washing up liquid Wipe dry afterwards Important safety information conta documented showing what has been done when where and by whom company and signature WASTE HANDLING At the end of their useful lifetime the product and any replaced parts must be treated as electronic waste WEEE in accordance with the local system for recycling Other materials such as paper and plastic are recycled as such Contact your local authority or the supplier for more information e f necessary disinfect with a cloth soaked with 70 alcohol or surface disinfectant Wipe dry afterwards e None of the eq
17. nt Weight Defibrillation protection Rapid negative pressure selection Measurement Weight Model Mains voltage and frequency Current rating AC input Classification Printer cable Control cable Vacuum hose Length Tensile resistance Material Battery pack option Manufacturer Lifetime Charging Control cable input USB input DC input Length of folding arm Table fixation Software 18 MDD Classification Class lla IEC 60 601 1 class I type CF with defibrillation protection In operation 10 to 40 C In storage 10 to 40 C 25 95 no condensation 700 1060 mbar Max 35 W 0 600 mbar 7 5 litres min at the patient end H 100 mm L 240 mm W 180 mm 1 1 kg 10 kOhm with surge protection 140 V 120 200 240 280 mbar H 30 mm L 110 mm W 135 mm 1 1 kg XP Power Model AFM 45US15 100 240 V 50 or 60 Hz Max 1 1 A IEC 320 C14 Class according to IEC 60 601 1 2 m DA 15 plug socket 2 8 m DE 9 plug socket 2 8m Extremities 1 2 m Chest 1 0 m Minimum 50 N Ag AgCl sensor fulfils recommendations of AAMI Biocompatibility and toxicology studies in accordance with biocompatibility In vitro cytotoxicity ISO 10993 5 Skin irritation ISO 10993 10 and Allergy ISO 10993 10 Rechargeable Li ion battery 11 1 V capacity 2 6 Ah Quickels Systems AB Catalogue number ON D103 Approximately 400 charging cycles Charging time approximately 2 hours DE 9 socket plug USB B socket pl
18. talogue number ON D3 Stockholm February 2 2015 Quickels Systems AB J burn Krister Sj berg Managing Director USER MANUAL 16 DECAPUS III Statement Manufacturer s liability Quickels Systems AB is only liable for safety and performance if e Assembly additions adjustments changes or repairs are only performed by persons who are authorised by Quickels Systems AB e The Decapus Ill apparatus is used in accordance with the instructions The customer s liability The user of this product is responsible for ensuring that acceptable maintenance routines are introduced Failure to do this may lead to unnecessary faults and potential health risks Apparatus identification Equipment from Quickels Systems AB is identified with an item and serial number on the back of the apparatus Care should be taken not to damage the serial number labels Copyright and brand information This document contains information that is protected by intellectual property rights All rights are reserved No part of this document may be copied reproduced or translated into another language without the prior written consent of Quickels Systems AB Other important information This information may change without prior notice Quickels Systems AB offers no guarantee of any kind regarding this material including but not limited to implied guarantees of saleability and suitability for specific purposes Quickels Systems AB accepts no r
19. ug DC plug 570 650 mm Clamp measurement 10 130 mm Compatible with Windows XP 7 and 8 Changes may occur without prior notice 19 oe Technical data conta OPERATOR PROFILE INTENDED USE NORMAL USE PATIENT GROUP SYSTEM LIFETIME OTHER Clinics with ECG training health centre workers hospitals or private care centres Must understand the language used in the user manual Record ECG signals from the patient and transfer these to an ECG printer for the purpose of discovering checking various types of deviant heart rhythms The system is intended for recording rest and stress ECG although not for longer than 40 minutes Normal use means about 25 resting ECGs per day 5 min per round From 5 years Not intended for patients with open wounds or other major skin damage in the regions where Quickels electrodes are applied 10 years Materials in the Quickels electrodes and signal modules do not contain latex The material in the patient module and pump module covers is made of ABS PC plastic Changes may occur without prior notice
20. uipment should ever be immersed into fluids of any kind Nor should liquid be sucked through the system e No part of the system should ever be hot sterilised with water steam or hot air Nor should ether be used If it is decided to use the same Quickels electrodes on more than one patient clean and disinfect by wiping with a cloth dampened with 70 alcohol PREVENTIVE MAINTENANCE For safe and trouble free use of Decapus lll preventive maintenance is required at least once a year as follows e Inspection for visible damage e nspection of the arm e Inspection of cables e Check on power supply and functional earthing e Check for current leakage e Checking the pump module s vacuum functions e Checking the signal modules valve and filter functions e fthe system is equipped with a battery Check battery and charger Rectify any faults If in any doubt consult authorised service personnel For more information please see the Service manual Decapus lll SERVICE Repairs to Decapus Ill or service measures if Decapus III is not working must be performed by Quickels Systems AB or our appointed and authorised agents see www quickels com If any parts are replaced original spares must be used Measures carried out must be Key to symbols CE label Off on Non sterile Dispose of as Recycling Service needed Ael electronic waste a Follow the m Connected to manufacturer s i Keep dry i the ma
Download Pdf Manuals
Related Search