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1. Action alarm Function Description Display screen Change the battery at the earliest convenient time but not later than five hours after the low battery Battery When the battery CHANGE alarm monitoring power is becoming low BATTERY Caution If the battery power is too low the ECOLITE 4000 will not function at all 6 4 AFTER USE 6 4 1 SWITCHING OFF THE DEVICE Switching off manually The ECOlite 4000 can be switched off when treatment is no longer required or it is necessary to interrupt it by pressing the ON OFF button on the front of the unit for approximately 3 seconds e An audible signal will confirm the unit is switched off e The current settings will be stored automatically Switching off automatically lf the device is switched on or being used but no breathing has been detected by the ECOlite 4000 for one minute e The display shows CHECK CANNULA and an audible signal sounds e After another 30 seconds without any corrective action inhalation the unit will switch off e The current settings will be stored automatically AN After ending a therapy close the valve on the supply in order to avoid wasting oxygen 6 4 2 DISCONNECTING THE DEVICE Before disconnecting the ECOlite 4000 from the gas source e Close the oxygen supply from the cylinder reservoir disconnect the connector of the spiral hose from the device and take off the nasal cannula e Disconnect the spiral hose from the oxygen sour2. 2 EEC relating to medical devices Class lla European Economic Area Regulatory status EEA 0 5 to 8 l min which corresponds to 5 80 ml Cycle output bol Functional performance per bolus a monitoring Alarms Te ne o oxygen supply No inhalation inhalation 0 5 1 5 I min 30 Accuracy 2 8 I min 15 Power supply Battery 2x LR6 AA Alkaline 1 5 V Oxygen supply Minimum 4 litres per minute Height 101 mm Dimensions Width 85 mm Dimensions and weight Depth 32 mm Weight 184 g without battery Operating 10 C to 40 C Ambient temperature Storage 40 C to 70 C Transport 40 C to 70 C Operating 25 to 95 Environmental conditions Relative humidity Storage 25 to 95 Transport 25 to 95 Operating 80 106 kPa Atmospheric pressure Storage 70 106 kPa Transport 70 106 kPa 10 12 Q GLOSSARY Consult Instruction for use Suitable for Home care UN Eaton BF type equipment Nasal canula connection Keep away from heat and Keep away from oil wr Serial number and grease Rom Upper and lower humidity limit m Order number K Upper and lower temperature limit EE Fragile Date of manufacture O Batch number Take back equipment for recycling Outlet parameter Do not dispose equipment into CR unsorted municipal waste WARRANTY The Standard Warranty period is two years from date of receipt by the GCE Customer or if this is not known 2 years from time of the product manufacture s
3. ECOlite 4000 EN GAS SAVER INSTRUCTION FOR USE i Ol ECOlite 4000 aencdilint Page 1 12 GCE mediline Security in action FOREWORD e The GCE ECOlite 4000 unit is a medical device for conserving oxygen classifi ed as Class Ila pursuant to e Directive 93 42 EEC concerning medical devices e Compliance with the basic requirements of Directive 93 42 EEC is on the basis of EN ISO 18779 e According to the type of protection from electrical shock the product is included in Class BF e The product can be used simultaneously with a pacemaker INTENDED USE ECOlite is for use by patients who have been prescribed oxygen therapy by a health professional Oxygen therapy is intended for the treatment of a wide range of pulmonary diseases and support treatment for cardiovascular diseases The ECOlite equipment enables efficient dispensing of oxygen to the patient by eliminating the wastage of oxygen which normally occurs with constant flow systems In principle a controlled pulse of oxygen is delivered to the patient in the initial phase of inspiration This ensures the oxygen gas reaches the alveoli in the initial phase of inspiration and the remaining airways are not unnecessarily filled with oxygen The oxygen saving is substantial and the mucous membrane is proportionally less stressed due to the reduced drying out effect from the oxygen The dosage and timing of oxygen delivery is controlled by a microproces
4. ECOlite 4000 may only be used with approved accessories and ina mode prescribed by the physician Using it for a therapy other than oxygen therapy is not permitted Connection of the device to the oxygen source must conform to applicable national standards Never use a lubricant or oils with the oxygen supply device since spontaneous ignition may occur Do not put the ECOlite 4000 into operation with the presence of open flames e g during smoking and do not use humidifiers The ECOlite 4000 must be used in accordance with the information for EMC given in this Instruction for use Transportable and mobile high frequency equipment can have influence on the ECOlite 4000 Various equipment can influence each other during operation To mitigate the influence it might be necessary for example to change the position of such equipment or to shield it The product and the related equipment must be protected from mechanical damage and kept out of the reach of unauthorised persons KEEP THE PRODUCT AND ITS ASSOCIATED EQUIPMENT AWAY FROM e heat sources fire cigarettes flammable materials oil or grease especially be careful if hand cream is used water dust National laws decrees and regulations in relation to the prevention of accidents due to pressure equipment and environmental protection must be observed OXYGEN CONTRA INDICATIONS A At atmospheric pressure up to 60 oxygen is harmless 100 oxygen produces a coug
5. arked or on the front side of the device functions are being used Chapter 6 3 4 dosing for a flow rate of 0 5 1 5 I m is 30 ue change the operating mode e Press the two buttons marked and simultaneously a LANGUAGE sign will appear and holding it for approximately 2 seconds y the range of 0 5 8 litres per minute as displayed g i e Flow rates are adjusted in the interval of 0 5 e Supply settings can be adjusted at any time e The sensitivity of the sensor in the device is 0 13 for a flow rate of 2 8 I m it is 15 cenediline mamma e On the ECOlite 4000 device that is switched off press the button and hold it down Afterwards e Using the ON OFF button go to the MAN AUTO setting and using the buttons set the mode 6 3 2 OXYGEN SUPPLY VOLUMES on the screen by means of numerals and a ETERRA litre per minute by pressing the control buttons during use unless the fl ow blocking or key lock cm of water column the accuracy of oxygen raphic display of range 6 3 3 LANGUAGES To set the language e On the ECOlite 4000 device that is switched off press the button and hold it down Afterwards press the ON OFF button and also hold it down A PRESS KEY sign will appear Press the two buttons marked and simultaneously a LANGUAGE sign will appear e Set the required language by pressing the buttons e You will confirm your selection and simultaneously exit the setting by pre
6. ce e Remove the batteries from the device e Visually check the device or accessories for contamination and put it preferably into the shipping container It is necessary to take out the batteries if the ECOlite 4000 is not in use for some time ACCESSORIES e Standard accessories include e Cannula e Batteries Note For current spare part list please contact GCE e A nasal cannula designed for single use is supplied in addition to the ECOlite 4000 device as a standard Its design being made up of segments prevents a possible injury of the patient or his her choking When the cannula is used more times there is a danger of infection A This product contains the phthalates GCE s r o dissuade to use this product for children nursing mothers and pregnant women because these matters are dangerous e Additional accessories they are not part of the delivery comprises a portable belt bag a portable rucksack for the complete assembly and a cart for transporting the assembly For more detailed information contact the supplier 8 12 CLEANING Cleaning of the device Clean the device as necessary with a clean dry cloth Do not immerse it in water or any other cleaning liquid The nasal cannula is designed for single patient use Do not immerse the device in water or any liquid AN Do not use rough or abrasive cleaning materials as damage may result AN Do not expose the device to high temperature such as to a
7. ce in a good and legible condition throughout the product s lifetime 9 3 REPAIRS Repairs may only be carried out by persons authorised by GCE Each product sent for a repair to a person authorised by GCE shall be properly packed The reason for a repair must be clearly specified A short description of the fault and any reference to the complaint number will be helpful Some repairs concerning the replacement of damaged or missing components may be carried out by the product s user The following components may only be replaced e Cannula e Batteries e Spiral hose with connection e Battery compartment cover AN Besides batteries use original GCE parts only 9 12 A It is strictly forbidden to modify service or repair the product by personnel not employed or authorized by GCE 9 4 ENVIRONMENT There are no known risks associated with disposal of the ECOlite 4000 at the end of its lifetime Batteries and electronics should be disposed of at a specialised recycling facility The other components may be recycled in a standard manner 9 5 SPECIFICATIONS Specifications Product name Mediline ECOlite 4000 Oxygen Conserving device Manufactured bv The Mediline ECOlite 4000 has been y manufactured at GCE Manufacturer s information The month and year of manufacture is shown Year of Manufacture on the serial number label on the rear of the unit This mark on the product indicates compliance with Directive 93 4
8. des Manual shown as MANUAL on the display screen e In this mode the device will be delivering oxygen at the volume set on the display on each inhalation e The value on the display is fi xed and will remain so regardless of the user s breathing rate Aine shown as AUTO on the display screen In the automatic mode the operation of the unit is dependent on the user s breathing rate e If the breathing rate is less than 15 breaths per minute oxygen being delivered will be dosed in the volume selected by the user and shown on the display screen e If the breathing rate is higher than 15 breaths per minute the oxygen fl ow rate will automatically increase in a linear way up to double the flow rate of oxygen pre set on the screen but it will not exceed the maximum flow rate of 8 litres per minute The preset oxygen fl ow rate will be indicated in full symbols and digits on the screen with the additional amount indicated as half symbols A The flow rate and operating mode shall be prescribed by your physician so that it best suits your heath condition AN When using the device keep the connecting elements and the cannula in such a position in order to prevent any danger to the patient s health or life press the ON OFF button and also hold it down APRESS KEY sign will appear e You will confirm your selection and simultaneously exit the setting by pressing the ON OFF button e Oxygen flow rates can be adjusted to values in scale m
9. h after 6 hours and increasing breathlessness after 25 hours PERSONNEL INSTRUCTIONS AND TRAINING According to Medical Devices Directive 93 42 EEC the product provider must ensure that all personnel handling the product are provided with the operating instructions amp performance data and are fully trained to carry out that operation Trainees need to be supervised by an experienced person AN Do not use the device without being trained Training can be only done by a person with an appropriate education experience and knowledge that has been also trained by the manufacturer For further information about training programs please contact GCE PRODUCT DESCRIPTION The ECOlite 4000 is an electronic oxygen dosing device with a built in alarm function The ECOlite 4000 has a built in regulator that partially regulates the pressure In order to work it requires the supply of medical oxygen with a pressure of 1 6 5 bar and a minimum flow 4 litres per minute Oxygen flows from a cylinder reservoir through a pressure reducing valve before entering he ECOlite 4000 device and then onto the patient via a nasal cannula The incorporated microprocessor in the ECOlite 4000 regulates and controls the oxygen flow to the patient The valve which allows the oxygen to flow is open only for a very short time until the next time when the patient inhales This leads to the optimization of the amount of oxygen considering the course of inha
10. hown on the product Manufacturer The standard warranty is only valid for products handled according to Instruction for use IFU and general industry good practice and standards MANUFACTURER GCE s r o Tel 420 569 661 111 Zizkova 381 Fax 420 569 661 602 583 81 Chotebor http www gcegroup com 4 Czech Republic GCE s r o 0434 11 12 GCE Group is one of the world s leading companies in the field of gas control equipment The headquarters are in Malmo Sweden and the two major supply units are located in Europe and Asia The company operates 15 subsidiaries around the world and employs more than 850 people GCE Group includes four business areas Cutting amp Welding Process Applications Medical and High Purity Today s product portfolio corresponds to a large variety of applications from single pressure regulators and blowpipes for cutting and welding to sophisticated gas supply systems for medical and electronics industry applications CCC Gas Control Equipment GCE world wide http www gcegroup com Document Nr 735800000224 Date of issue 2014 05 02 Revision Nr 02 Tl A5 BAR V1
11. lation and thus a considerable saving by up to 2 3 of the volume and mucous 3 12 membranes are not excessively loaded at the same time The dosed amount of oxygen will penetrate the alveolus and be assimilated into the blood Nasal supply Spiral hose cannula with connector applied part type BF Battery Mediline compartment ECOlite 4000 cover rear side amp emedilinc ma AN The connector on the supply spiral hose differs with its function from national standards In the event of any problem with connection please contact the distributor the manufacturer FRONT VIEW Display screen ECOlite 4000 ae Oxygen inlet ON OFF button Outlet into cannula Control buttons eae ceomedilin OPERATION 6 1 ASSEMBLY e Before use place batteries they are part of the package into the device by pressing the flexible strip open the battery compartment cover and place the batteries into it Make sure that the batteries poles are connected according to the corresponding symbols at the bottom of the compartment 4 12 e Close the battery compartment cover i Batteries LR6 1 5V Alkaline Battery compartment e Fit the spiral hose onto the connector for oxygen inlet into the ECOlite 4000 device by means of the square two button adapter A click should be felt when it is connected correctly Pull the hose gently to confirm connection e Attach the other end of spiral hose
12. ld set off both by sound and an alert on the display gt gt gt oeoc AN If there is an abnormal sound noise gas leakage or any other problem stop using the product immediately and contact the supplier A We recommend conducting a functional test Chapter 6 3 5 every time before putting the device into operation 6 3 6 ALARM AND MONITORING FUNCTIONS A built in microprocessor in the ECOlite 4000 allows permanent monitoring of the most important functions Audible alarm Niseiial Goera Indicates that the sen A picture of flash ti p sor detects the start of ing light in top right No None ion l an inhalation effort hand corner When this happens check The oxygen flow ee ates The condition and tightness of Low Oxygen from the source is spiral hose connections supply insufficient to supply Satan For adequate oxygen supply the patient Function Description Display screen Action For any kinking and damage of the hose or the device The ECOlite 4000 will switch off automatically storing the current An audible settings signal is set off for 30 s Check the cannula for and the unit obstructions and replace it if will then turn necessary off automati cally Remember to shut off oxygen supply cylinder if the unit switches off When the device is in use and no breathing CHECK takes place for one CANNULA minute Monitoring breath impulses 7 12 Audible
13. n autoclave A Do not immerse the cannula or spiral hose in a liquid disinfectant the user cannot be certain they have eliminated the remaining moisture inside the hose which might damage the unit possibly endanger the patient MAINTENANCE 9 1 MAINTENANCE Prior to each use e Check the connections to the unit e Make sure that the battery does not require replacing e Check the device for physical damage e Conduct a functional test see Chapter 6 3 5 If any problem is identified with the unit contact the supplier of the ECOlite 4000 After every period of use it is recommended to e Change single use components nasal cannula e Clean the device as described above 9 2 LIFETIME AND SERVICE INTERVAL The maximum lifetime of the product is 10 years At the end of the product s life time 10 years at most the ECOlite 4000 device must be withdrawn from service To prevent reuse the owner shall make the ECOlite 4000 impossible to use or return it to GCE Contact your local representative for further details before returning the product AN No service check is needed during the 10 years lifetime of the ECOlite 4000 however all repairs to the product must be done by GCE authorised personnel GCE coding data The serial number is made up as follows YY MM XXXXX A Y 2 last numerals of the year M month X serial number A manufactured at GCE s r o CZ A The owner and user must preserve all the labels on the devi
14. sor in accordance with the chosen setting Dosage per breath is independent of breathing rate therefore additional oxygen is automatically delivered to the patient when breathing rate increases 2 1 IDENTIFIED PATIENT POPULATION e Age not specified e Weight not specified e Health status the user should not show signs of contra indications associated with the application of medical oxygen 2 2 THE DESIGNATED BODY PART OR TISSUE TYPE WHICH THE APPLICATION RELATES OR TO WHICH IT IS TO OPERATE e Oxygen therapeutic substance passes into the airways of the lungs and acts through the cardiovascular system e Cannula for application of the oxygen in contact with the skin of the face 2 3 INTENDED CONDITIONS OF USE e Environment designed for outdoor and indoor use see conditions Chapter 9 5 e Frequency of use Designed for multiple uses daily use one time use is limited by battery capacity and oxygen bottles e Location Protect from physical damage e Mobility The device is portable battery powered 2 4 INTENDED PROFILE e The device is intended for home using e Education are not subject to requirements for specialized education e Knowledge training of doctors prescribing therapy the study and knowledge of the user manual e Skills Ability to operate electronic devices 2 5 OPERATING PRINCIPLES e t must not come into contact with grease 2 12 OPERATIONAL TRANSPORT AND STORAGE SAFETY REQUIREMENTS The
15. ssing the ON OFF button and holding it for approximately 2 seconds 6 12 6 3 4 BLOCKING FUNCTION Key Lock To prevent buttons from being unintentionally pressed a key lock can be activated by pressing the control buttons and simultaneously To deactivate it press the control buttons and again Locked flow To change flow blocking e On the ECOlite 4000 device that is switched off press the button and hold it down Afterwards press the ON OFF button and also hold it down APRESS KEY sign will appear e Press the two buttons marked and simultaneously a LANGUAGE sign will appear e Using the ON OFF button go to the BLOCKED setting and using the buttons set the mode NO YES e You will confirm your selection and simultaneously exit the setting by pressing the ON OFF button and holding it for approximately 2 seconds e With activated fl ow blocking the unit will be working with the fl ow rate set on the device before blocking was activated 3 5 FUNCTIONAL TEST Switch on the ECOlite 4000 Choose a random setting e g 3 l m Breathe in through the cannula Make sure that there is a short puff of oxygen through the cannula by listening or feeling the flow Also make sure you can hear a slight click on each inhalation Check the display by pressing the and buttons the setting should change accordingly Activate the alarm by not breathing in the cannula After approx 1 minute the alarm shou
16. to the oxygen source pressure reducing valve using a standard connection quick connector e Attach a standard nasal cannula to the patient outlet connector on the ECOlite 4000 by firmly pushing the tube over the connector 6 2 SWITCHING ON e Prior to every use always check that correct components are delivered or used and make sure that they are complete and clean e If the unit is being used with an oxygen supply source with adjustable fl ow rates set the flow rate on the supply source to 4 litres per minute or to the closest setting above Check the cylinder pressure gauge or LOX system to ensure sufficient oxygen supply in the range of 1 6 5 bar e Open the oxygen cylinder valve or LOX system as instructed by your oxygen supplier e Put on the supply nasal cannula e Switch on the ECOlite 4000 by firmly pressing the on off button on the front of the unit for 2 seconds The ECOlite 4000 will automatically perform a short operating check ca 4 s e The unit is now ready for use and will operate at the basic settings AN Do not use the device if the cylinder content gauge on the supply valve is in the red low pressure zone AN Make sure that there is sufficient gas in the cylinders to complete the treatment AN Oxygen used for medical purposes is a drug when used incorrectly it may cause side effects 5 12 6 3 OPERATION 6 3 1 OPERATING MODE The ECOlite 4000 unit can be adjusted for two different operating mo
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