English ATMOS S 042 NPWT. Operating instructions B Index: 22

Transcription

1 English Operating instructions ATMOS S 042 NPWT B Index: 22

2 Table of contents 1.0 Introduction Notes on operating instructions Intended purpose (indication) Function Explanation of symbols Scope of supply Transport and storage For your Safety Special precautionary measures Presentation Device overview Buttons and symbols Prepare and assemble vacuum unit Charge battery Connection and removal of shoulder and hip strap Attachment and removal of secretion canister Connecting/removing the vacuum unit with the wound dressing set Attachment of stand holder Attachment / removing the vacuum unit at / from the stand holder Operating Basic functions Switch on/off vacuum unit Set negative vacuum pressure Start/interrupt therapy Switch on/off intermittence Key lock Language selection Basic settings Brightness Day / Night mode Warning messages Battery empty Tube clogged Canister full Leakage Battery lifetime exceeded Automatoc turning off Safety-related check Cleaning and care General information on cleaning and disinfection Cleaning the device surface Cleaning the shoulder and hip strap Recommended disinfectants for surfaces Hygiene plan Maintenance and services Basic information Repairs Handling of rechargeable batteries Exchange of accumulators Trouble-shooting Accessories, consumables and spare parts Accessories Consumables Spare parts Technical specifications Disposal Notes on EMC Further information, accessories, consumables and spare parts are available from: ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Straße Lenzkirch Germany Phone Fax (Service Centre) atmos@atmosmed.com 2

3 1.0 Introduction 1.1 Notes on operating instructions These operating instructions are valid from software version 1.1. These operating instructions contain important notes on how to operate the ATMOS S 042 NPWT safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and down-time. That increases, amongst other things, the reliability and service-life of the device. Please also observe the operating instructions for the dressing kits and secretion canisters. The operating instructions for the ATMOS S 042 NPWT presuppose that their contents are known. These operating instructions serve not only for new operating personnel to be instructed in its use, but also for use as a reference manual. Full or partial reproduction is subject to prior written approval from ATMOS. These operating instructions must always be kept available near the device. Care and safety inspections in conjunction with professional execution provide for operational safety and readiness for use of your ATMOS S 042 NPWT and are therefore a must besides regular cleaning. Repair work and safety inspections may be carried out only by expert personnel authorised by ATMOS. By applying only original spare parts you will have the guarantee that operational safety, readiness for work and the value of your ATMOS S 042 NPWT will be preserved. The product ATMOS S 042 NPWT bears CE marking CE 0124 according to the EC Directive of the council for medical products 93/42/EEC and meets the basic requirements of annex I of this Directive. The product ATMOS S 042 NPWT complies with all applicable requirements of the directive 2011/65/EC restricting the use of certain hazardous substances in electrical and electronic equipment ( RoHS ). The declaration of conformity and our general standard terms and conditions can be obtained on our website at The quality management system applied at ATMOS has been certified according to international standards EN ISO 9001 and EN ISO Prior to start-up please peruse chapter 2.0 For your safety, in order to be prepared for any possible dangerous situations. 1.2 Intended purpose (indication) Main function: Generation of a controlled negative pressure on an acute or chronic wound. Med. Indication/ application: For application on humans. Specification of the main function: As a result of the generated controlled negative pressure wound secretion and infected materials are transported from the wound via a wound dressing with a connecting hose system and is then collected in a secretion canister. Due to the negative pressure the cell growth and the blood flow are encouraged. Application organ: Chronic and acute wounds on the skin which do not close by primary wound healing. Duration of application: Under normal circumstances a continuous application over a period of more than 30 days. Application environment: Suitable for application in clinics, medical fields and home enviroment. The application of the negative pressure device may only be conducted under physicians instructed and by medical expert staff. Contraindications: Contraindications exist by patients with malignant tumor wounds (non enteric fistulas) which hane not yet been examined, osteomyelitis or necrotic tissue. The ATMOS S 042 NPWT must not be applied to exposed nerves, anastomis areas, blood vessels or organs.the vacuum unit must not be used: - for non-medical applications - in the presence of flammable or explosive gases or liquids The system is not evaluated for the emergency medicine in the rescue area (rescue vehicle, accident location) This product is: Active Sterility: canister system is sterile Disposable product / reprocessing: Canisters are disposable products 1.3 Function The ATMOS S 042 NPWT is a particularly convenient suction device for negative pressure wound therapy. The vacuum unit is operated by an electromotive maintenance-free membrane pump. During operation the pump creates a vacuum in the wound dressing, the tubing system and the secretion canister; this vacuum is used to suck secretions. The vacuum unit automatically creates, controls and monitors the set therapy values. The secretion is collected in the respectively provided secretion canister. A special filter technology prevents penetration of liquids, bacteria and odours into the device. Therapy settings can be made using the touch screen. The vacuum unit is equipped with a rechargeable lithium ionic battery. Safe recharging of the battery is ensured by a microprocessor-controlled electronic charge system located in the vacuum unit. The main characteristic is the regulation (in a normal case) and the limitation (in the event of a fault) of the maximum possible negative pressure of the pump to approx. -500mmHg. 3

4 1.0 Introduction 1.4 Explanation of symbols Short cuts / symbols contained in this manual Please read, important information General information Move, plug... in this direction 2 This product is not re-sterilisable. Numeration Turn, shift... in this direction Pictures contained in this manual Warning, special diligent notice Professional disposal Symbols on the ATMOS S 042 NPWT SN Serial number Please observe operating instructions REF Order number Please observe operating instructions Manufacturing date Application part type BF Manufacturer The CE sign shows that this product meets the appropriate requirements of the EC Directives. IP33 Protection class II Type of protection 1.5 Scope of supply Prior to dispatch, the ATMOS S 042 NPWT was subjected to an extensive functional test and has been carefully packed. Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt (see delivery note). 1.6 Transport and storage The transport of the device may be effected only in a dispatch carton upholstered and offering suffi cient protection. Please document and report damages in transit immediately. vacuum device mains cable The unit must be allowed to stand for up to six hours at room temperature prior to starting up for the fi rst time following transport at temperatures below freezing. The unit may not be operated if it has not acclimatised as this might damage its diaphragms. shoulder strap operating instructions battery recharger 4

5 2.0 For your Safety General Information For your Safety The ATMOS S 042 NPWT is designed in accordance with IEC /EN It is a device which meets the VDE protection class II. It may only be connected to a properly installed earthed wall socket. Dispose of the packing material in a proper manner. Please observe national regulations ATMOS is not responsible for damage to people or goods if non-original ATMOS parts are used, the information in these operating instructions are disregarded, assembly, new installations, modifi cations, extensions and repairs are done by people who are not authorised by ATMOS. Prior to putting into operation the device, mains cable, accessories and connecting cables have to be checked for any damage. Damaged cables have to be replaced immediately. During operation, the user is obliged to regularly check the negative pressure unit for proper function. In the unlikely event of failure of the negative pressure unit, the user has to make arrangements to continue the treatment of patients with suitable methods. Please observe all precautionary measures for infection control of patients and the care personnel generally applicable to you and your institution in order to reduce the risk of infections and transfer of pathogens. Please take corresponding protective measures (e.g. wearing of gloves, protective coat, face and eye protection) if contacting body liquids or handling contaminated parts. These operating instructions correspond to the design of the device and the situation of the safety standards on which they are based when they were printed. The circuits, processes, names, software programmes and devices are all covered by patents. Danger for users, patients and third parties Protect yourself against an electric shock. Prior to putting into operation the device, mains cable, accessories and connecting cables have to be checked for any damage. Damaged cables have to be replaced immediately. Only undamaged mains connection must be used. Only use the provided medical power supply unit (manufacturer: GlobTek Inc., model: GTM T2). Do not use an extension lead. You may only disconnect the device from the power supply via the mains cable. The device does not have a mains switch. Ensure that the mains cable is easily accessible and can be disconnected from the power supply at all times. To disconnect the device from the mains fi rst pull out the plug from the wall socket. Only then disconnect the connection cable from the device. Never touch the plug or cable with wet hands. Do not change anything on the device without prior permission from the manufacturer. The patient should not take a shower or have a bath when using the ATMOS S 042 NPWT. Interruption of therapy for such purpose should only be made in consultation with the attending physician. Risk of strangulation Keep the mains cable, secretion hose and shoulder strap out of the reach of children. You should regularly check where these items are located. Confirm therapeutic success Continuous vacuum is recommended rather than intermittent vacuum with regard to instable structures, e.g. instable chest wall or injured fascia. This helps to reduce movement and stabilise the wound bed. Continuous vacuum treatment is generally recommended for patients with an increased risk of bleeding, exsudative or acute enteric fi stula wounds and with fresh fl aps/transplants. Wound exudate or blood can accumulate in the wound dressing. This can lead to maceration, infection or an undetected haemorrhage. Therefore regularly check the dressing. How frequently the wound dressing needs to be checked and changed depends on the patient as well as the wound. Observe the instructions from the attending physician. Blockages in the wound dressing, partial blockages in the hose system and small-scale leakages cannot be recognized by the device. In such a case the device continues to be fully functional even though there is no negative pressure at the wound or the pressure is too low. Therefore regularly check the wound pressure. How frequently the wound dressing needs to be checked and changed depends on the patient as well as the wound. Observe the instructions from the attending physician. If you have 2 wounds connected to the device via a Y-connector then please pay attention to the following: Wounds which are connected to a negative pressure system via a Y-connector must be regularly checked by health care professionals. The device only recognizes leakages and blockages when they appear simultaneously in the hose between the device and the Y-connector or in both hoses between the Y-connector and the wound. If the leakage or blockage is only in one of the hoses between the Y-connector and the wound then the device does not recognize this. The acoustic and visual warning does not appear. As a result health care professionals must check the secretion hose for blockages and the negative pressure at the wound. Avoid the risk of dislocation or clogging of the tube by regularly checking the hosing system and its connections for leakages and kinks. The control panel should always be clearly in view for the operators and be easy to reach. Modifi cations to the therapy settings on the device may only be conducted by health care professionals. Prior to start up the device, the user should verify correct functioning of the optical and acoustic display. Avoid the risk of the device falling to the fl oor. If the device should fall always contact the ATMOS Service or 5

6 2.0 For your Safety an authorized service partner. Change of dressing: Please observe the respective instructions for use of the used wound dressing sets. Please regularly check the fi lling level of the secretion canister to ensure problem-free operation of the vacuum unit. If the maximum fi lling level is achieved, please replace the canister with a new secretion canister. The set negative pressure should never cause pain. If the patient states discomfort, you should consider a reduction of the negative pressure. Risk of infection The device should always be used in vertical position. Prior to use please check the secretion canister and the connecting tubes on any damage. Do not use damaged secretion canisters. Multiple use of components which are marked with a 2 is forbidden. In case of repeated use these components lose their function and there is a high infection risk. No secretion may enter the device. If wound secretion has entered the device it must be checked by the customer service before it is used again. Removal of the canister from the device during therapy should only by made by instructed personnel. Danger of explosion The ATMOS S 042 NPWT is not designed for operation within areas where there is a risk of explosion and in oxygen rich enviroments. Areas that are at risk from explosions can arise due to the use of combustible anaesthetics, skin cleaning and skin disinfecting materials. Avoid damage to the device The environmental conditions given in the Technical Specifi cations (section 9.0) must be observed. When the device is in operation patients, users and third parties must adhere to the ambient conditions. Temporary lower deviations resp. higher deviations of the ambient temperature have no infl uence to the device functions. However if you do not comply with the ambient temperature over a longer period of time the device can get damaged. Disfectant should not enter the device. If disfectant has penetrated the device, then it must be dried thoroughly and subsequently an effi ciency control must be conducted. If the desired target vacuum is reached then the device may continue to be used. If not, the device must undergo a service check before it resumes operation. Prior to start up the device it should be checked whether the mains voltage and frequency correspond to the values stated on the device. Never place the device directly beside other devices. Never stack the device After a long journey at temperatures under the freezing point the device must be allowed to stand for up to six hours at room temperature before it is used for the fi rst time. If the device is not acclimatised, it must not be operated, since the diaphragm of the unit might be damaged if it runs in this condition. 2.1 Special precautionary measures Special precautionary measures are indicated for patients with acute bleedings, coagulation disorders as well as for patients treated with anticoagulants. Here, the 800 ml secretion canister should not be used. In case of sudden or increased bleeding, treatment should be stopped immediately. In such a case the attending physician should be informed, and suitable haemostatic measures should be taken. Blood vessels and organs should be suffi ciently protected by overlying fascias, tissue or other protective layers. Special precautionary measures should be taken in case of infected, weakened, irradiated or sutured blood vessels or organs. Bone fragments or sharp edges may damage blood vessels or organs, and thus should be covered or removed before application of negative pressure wound therapy. Wounds with intestinal fistulas should only be treated with ATMOS S 042 NPWT when observing special precautionary measures. With movable parts of the body which cannot be immobilised, a continuous (but not intermittent) therapy is indicated to minimise irritations. Therapy should be stopped in the case of spinal injuries of the patient with development of an autonomic hyperreflexia. The ATMOS S 042 NPWT was not evaluated for application in paediatrics. Before prescribing application with a child, please verify weight and height of the patient. The ATMOS S 042 NPWT is not compatible with MRT (magnetic resonance tomography). Thus, do not operate the ATMOS S 042 NPWT in the vicinity of an MRT. During operation, transport, repair, cleaning and disposal of the ATMOS S 042 NPWT or its accessories, reasonable general precautionary measures should be taken. Improper handling may result in the risk of inhalation of infectious substances or the risk of contamination to internal parts of the device. The vacuum unit must only be used by a physician or - upon medical request - by qualified and authorised personnel. The user should be correspondingly trained and should provide of knowledge in the field of special medical applications which the ATMOS S 042 NPWT was designed for. 6

7 3.0 Installation and starting-up 3.1 Device overview Front: Rear: Touch screen On/Off button Charging plug connector Secretion canister (not included in the scope of delivery) Secretion canister releasing device Secretion canister: Secretion canister connections Carrying strap hinge Name plate Canister guide USB connectors (no function for users) During the therapy the USB connections have no function. They may only be used by an authorized service. Never plug in an active device Bacteria filter Canister guide 7

8 3.0 Installation and starting-up 3.2 Buttons and symbols The ATMOS S 042 NPWT is equipped with a touch screen. The whole operation is performed by touching the buttons displayed on the screen. Operation: The buttons on the screen always indicate what will happen after pressing the respective button. Attention Any touch of the screen will be signalised with a sound. However, such button sound does not indicate that the selected button is activated. Button Name Function On/Off button When touching this button for two seconds the vacuum unit can be switched on and off. Start button Stop button Menu button Plus button Minus button Intermit button Continuous button Intermittent menu Save/Back Up Down Close Starts therapy. Stops therapy. For calling up submenus. For increasing the displayed values. For decreasing the displayed values. For activation of the intermittent vacuum treatment. When activated it is green framed. For activation of continuous vacuum treatment. When activated it is green framed. Touch this button to access the intermittent menu. Here you can set the intermittent parameters for optimisation of therapy. When activated it is green framed. With this button you save the set value and go back one menu level. Attention: If you do not want to save the set values, wait until the screen returns to the previous menu level. This button is used to scroll upwards in menus. This button is used to scroll downwards in menus. This button is used to close the warning window and to suppress the alert. Symbol Definition Battery charging status. Key lock activated. Key lock deactivated. Leakage display. Shows leak tightness and/or leakage of the system using the colours green, yellow and red. (Only visible during therapy) Alert is suppressed. If the cause for the alert is remedied, the symbol will automatically disappear. USB stick connected. 8

9 3.0 Installation and starting-up 3.3 Prepare and assemble vacuum unit Connection and removal of shoulder and hip strap Charge battery 4 3 Attention The battery should be fully charged before fi rst commissioning of the ATMOS S 042 NPWT. Only the charger supplied by ATMOS should be used. The negative pressure unit should be recharged in a cool place without any direct solar radiation. Recharging period is prolonged if the ambient temperature is >25 C. Improper use of the device may lead to serious damage. The guarantee does not cover any damage due to improper handling. 1 5 Snap link for attachment to the negative pressure unit Snap link for attachment to the negative pressure unit Snap link for attachment to the negative pressure unit Strap closure for attachment to the bed Strap closure for attachment to the bed 2 Connect the charging plug of the charger to the charging connector of the vacuum unit. Attaching the shoulder strap Take the snap link and hook it to one of the attachment loops on your negative pressure unit. Now hook the other snap link to the second attachment loop on your negative pressure unit. Connect the charger with the supplied countryspecific power cord. Attaching the negative pressure unit to patient s bed To prepare attachment to a patient s bed hook the snap link instead of snap link to the device.. Now you only need to connect the strap ends and to each other, to attach the negative pressure unit to a patient s bed. Connect the mains plug to the mains outlet. The vacuum unit then displays the moving symbol on the screen. When the battery is fully charged (the symbol does not move any more ), disconnect the mains plug from the mains outlet. Unlocking the negative pressure unit for removal Disconnect the charging plug from the charging connection of the vacuum unit. Information: If the charging status of the battery is low, then the vacuum unit will raise an alarm and the screen with display a warning window (see chapter Warning messages). If the battery is too weak for further operation, the vacuum unit will automatically switch off. Press the unlocking device of the strap closure laterally and keep it pressed. Now pull the two ends apart. To make it ready for shoulder attachment exchange the snap link wtih the snap link. 9

10 3.0 Installation and starting-up Attachment and removal of secretion canister Connecting/removing the vacuum unit with the wound dressing set Attention The secretion canisters of your vacuum unit are sterile units which can be used in sterile surgery environments. Please observe the respective operating instructions of the secretion canisters. Attention The ATMOS vacuum system provides of a double lumen suction tubing system to prevent blocking of the suction tube. Ensure that the connections are always correctly connected in order to avoid faults. Attachment of secretion canister: Carefully remove the sterile secretion canister from the peel packaging. Ensure that the attached tube does not fall onto unsterile ground. Connecting: Connect the tube ends of the container and the wound dressing kit with each other. Now place the canister - with a slight incline - 13 into the guide pins of the device Tilt the secretion canister into the direction of the vacuum unit until it clicks into place 14. Perform a slight tension test at the secretion canister to ensure that it is tightly fitted to the device. Removal of secretion canister: Remove the secretion canister as described in the chapter Connecting/removing the vacuum unit with the wound dressing set. Tube must not be clamped Do not use clamp means Because of EP B1 valid in AT, BE, CH, DE, DK, ES, FR, GB, GR, IE, IT, LI, LU, MC, NL, PT, SE. Press the unlocking button (blue) at your vacuum unit and remove the secretion canister in a slightly inclined position. Properly dispose of the secretion canister. Pay attention to country-specifi c regulations for disposal. 10

11 3.0 Installation and starting-up Removal: Pull the fixing pin from the fixing at the bottom side of the stand holder. Press the lateral unlocking button of the tube connector and keep the button pressed. Turn the holder clamp until the fixing pin clicks into place at the next fixing. Pull apart both ends. Attention Ensure that the fixing pin correctly clicked into place before attaching the vacuum unit on top. Prior to disposal break off the sealing plugs on the connector and plug it into the secretion hose on the device. This will ensure that the secretion cannot leak from the canister. The tube may not be clamped. Please do not use any clamps. Attaching the holder clamp: Turn the turning knob of the holder clamp clockwise until the clamp can be attached to the desired fixture Attachment of stand holder (accessory part) Turning of holder clamp: The stand holder may be attached horizontally and vertically - to plates (e.g. table boards), pipes and stands with a diameter up to 40 mm. Turn the turning knob clockwise to fix the holder clamp. Attention Ensure that the stand holder is firmly attached to the desired fixture. 11

12 3.0 Installation and starting-up Attaching/removing the vacuum unit at/from the stand holder Attention Firmly hold the vacuum unit during the whole process. Place the vacuum unit onto the stand holder. Ensure that the thread at the bottom of the vacuum unit is directly above the fixing screw of the stand holder. Turn the fixing screw counter-clockwise to fix the vacuum unit. Removal of the vacuum unit is performed in reversed order. 12

13 4.0 Operation 4.1 Basic functions Switching the negative pressure unit on and off How to switch on the negative pressure unit: Touch the key for two seconds. When used for the first time the language selection menu appears. Select the desired language here by touching the screen. A tick appears next to the selected language Switching the intermittent mode on and off With your negative pressure unit, you have the option of selecting between continuous and intermittent mode. In contrast to the continuous mode, which operates with a negative pressure that remains the same, the intermittent mode allows therapy with changing pressure intervals. Switching the intermittent mode on: To switch on the intermittent mode press the key. The key appears on the screen. This key indicates the set values of the intermittent mode and is framed in green. Confirm your entry with main screen. in order to return to the To switch the negative pressure unit off touch the key for two seconds Setting the negative pressure On initial delivery, the ATMOS S 042 NPWT is preset to a negative pressure of 125 mmhg. By touching the key, you can increase the negative pressure in steps of 5 mmhg. To reduce the negative pressure, touch the key. Change values: To adapt the preset values touch the You reach the intermittent menu. key. How to adjust the preset values: Touch the value you would like to change with a finger. The respective field is marked in dark blue Starting/interrupting the therapy Attention Before starting the therapy, ensure that everything is properly connected and that all the therapy parameters have been set. To start therapy, touch the key. The negative pressure unit starts to generate the set negative pressure. Now touch the or key to set the desired value. To save the newly set values touch the key. Attention The values are only saved if the intermittent menu is closed with the key. If you do not wish to accept the values, you have set, wait until the screen automatically returns to the main menu, but do not touch the screen for this. To interrupt or to finish therapy, touch the key. Attention If the therapy is not started again the device switches itself off after 30 minutes (after warning massage). 13

14 4.0 Operation Key lock The ATMOS S 042 NPWT is equipped with an automatic keylock. 1. Automatic activation of the keylock. If no adjustments are made to the settings on the screen over a period of one minute then the keylock is automatically activated. This prevents accidental operation of the device. The symbol appears in the display. When the keylock is activated the display turns black after 5 minutes. 2. Manual activation of the keylock. When the therapy values are set and therapy is initiated then the keylock can be manually activated. When the - symbol blinks you can activate the keylock Selecting the language Various languages can be set on the ATMOS S 042 NPWT. Proceed as follows: Press the key to reach the submenu. Now select the field Language to enter the language selection menu. Touch the symbol to activate the keylock. When the keylock is activated the display turns black after 5 minutes. 3. Unlock the keylock Briefl y touch the screen The screen is activated when the symbol appears and blinks.. Select the desired language now in the language selection menu by touching the screen. A tick appears next to the selected language. To save the settings touch the Basic settings key. Touch the key to reach the submenu. Now select the field Basic settings. You will now be asked whether you wish to return to the basic settings. Touch the symbol. The symbol appears and blinks. Touch the symbol. As soon as the symbol blinks the keylock is deactivated. If you do not touch both the symbols and within 6 seconds the keylock will be reactivated. Now you must once again touch the screen so that the symbol appears. Press Yes to return to the basic settings. Press No to cancel. Attention The set language is not changed by returning to Basic settings. 14

15 4.0 Operation Brightness Your negative pressure unit automatically adjusts the brightness of the screen to match the prevailing brightness of the room. If the preset brightness does not meet your requirements, you can adjust the brightness as follows. Touch the key to reach the submenu. Now select the field Brightness. The field is marked in dark blue and the and keys are shown on the right hand side Day / Night mode The negative pressure unit features a day / night mode. This means that it automatically reacts to match the prevailing brightness of the room. Storage battery mode: If the device is set to storage battery mode, the screen goes black after 5 minutes. If the brightness of the room is low, the background screen in the display becomes dark. Mains power mode: If the device is connected to the mains power and the room brightness is low, the background screen in the display becomes dark. Now set the desired value with the and keys. To save the settings touch the key. Attention The screen reacts with a delay of two seconds. 15

16 4.0 Operation 4.2 Warning messages In the case of a warning the health care professionals must be informed immediately. If the key is pressed the acoustic and visual warning can be suppressed for 5 minutes then the warning is repeated. Please note that the device cannot recognize all critical situations. Therefore in the following cases there is no warning: Wound exudate or blood can accumulate in the wound dressing. This can lead to maceration, infection or an undetected haemorrhage. Therefore regularly check the dressing. How frequently the wound dressing needs to be checked and changed depends on the patient as well as the wound. Observe the instructions from the attending physician. Blockages in the wound dressing, partial blockages in the hose system and small-scale leakages cannot be recognized by the device. In such a case the device continues to be fully functional even though there is no negative pressure at the wound or the pressure is too low. Therefore regularly check the wound pressure. How frequently the wound dressing needs to be checked and changed depends on the patient as well as the wound. Observe the instructions from the attending physician Storage battery low The warning window (picture Storage battery low ) appears if the remaining operating time is less than one hour. Please connect the mains charger as soon as possible. By touching the key this warning message can be suppressed for 5 minutes and the therapy can be continued unhindered. Attention If the message is ignored, the negative pressure unit switches off automatically in order to protect the storage battery (see Chapter Automatic switching off ) Tube blocked The error message (picture below) appears if the negative pressure unit detects a blockage in the container or tubing system The following causes can trigger the error message: Kinks in the tubing system: Store the tube in such a way that no kinks can occur. Blockages at the connection points: Check all connection points for possible blockage and incorrect connections By touching the key this warning message can be suppressed for 5 minutes. Attention If the fault cannot be rectified by way of the above measures, the exudate container should be changed. 16

17 4.0 Operation Container full Storage battery service life exceeded If the average lifetime of the battery is reached, this message will be displayed with every new start of the vacuum unit. The following causes trigger the error message: Container full: Change the exudate container. Blockage of the bacteria filter in the canister: If the bacteria filter has become moist with exudate, it becomes blocked. Change the exudate container. By touching the key this warning message can be suppressed for 5 minutes. Attention In order to prevent blockage of the filter make sure that the negative pressure unit is set up in stable position Leakage This warning message can be closed by touching the key and only appears again when the negative pressure unit is restarted. In order to avoid operational failure of the negative pressure unit have the storage battery replaced by the manufacturer as soon as possible Automatic switching off If a mains charger has not been connected, in spite of repeated "Storage battery low" warning messages, the negative pressure unit switches itself off automatically Attention The negative pressure unit can only be switched on again once a mains charger has been connected, thereby recharging the storage battery. This error message is triggered by leakage in the system which cannot be compensated for by the negative pressure unit. Check the wound dressing for any leakage. Check all connections for leakage. Check whether the container is firmly connected to the negative pressure unit Safety check A safety check is needed every two years. The following warning window appears if this condition is true. By touching the key this warning message can be suppressed for 5 minutes. If it is not possible to rectify the leakage with these measures then the wound dressing and the hose system must be replaced. This warning message can be closed by touching the key and only appears again when the negative pressure unit is restarted. 17

18 5.0 Cleaning and care 5.1 General information on cleaning and disinfection The way the device is used determines its reliability and safety. These hygiene measures are indispensable for protecting the patient and the user and for maintaining a safe and reliable device. Clean and disinfect the surface of the negative pressure device acc. to the procedure which applies to other electronic non-submersible medical products. Prior to cleaning please remove the mains cable, power supply and charging plug from the device. The described measures for cleaning and disinfection do not replace valid rules for operating the device Plastic parts might get dyed by some disinfectants. Prevent liquids from penetrating the device. Please observe the instructions for use prescribed by the manufacturers of disinfectants. Especially regarding concentration, their suitability for use and the contact time. Do not use disinfectants containing concentrated organic or anorganic acids or bases, since these may cause corrosion damages. disinfectants containing chloramides or phenol derivatives since these may cause stress cracks in the material used for the housing of the unit. Please always wear disposable gloves for any work you perform. For disinfection all the surface disinfectants are suitable which are stated in chapter 5.4 Recommended disinfectants. Prior to cleaning the device please remove and dispose all disposable parts like secretion canister, dressing and tubes. Basically all parts (secretion canister, tubes and dressing kits) must be disposed which come into contact with suction material when the device is used in another patient. We recommend you to document any maintenance work and also any exchange of parts. 5.2 Cleaning the device surface Prior to use the device in another patient the complete device surface must always be cleaned with a damp (not wet) cloth and disinfected with a surface disinfection solution. It is important that disinfectant does not enter the device. Do not use a spray disinfectant directly on the device, but spray it on a cloth (only damp not wet) During cleaning and disinfection the device must be switched off. Do not switch the device back on until the cleaning and disinfectants on the surface have dried completely. In case the device is used in one patient only the device surface should be cleaned if it is contaminated however at least once every week with a damp (not wet) cloth and afterwards be disinfected with a surface disinfectant. Attention The device may never be autoclaved, rinsed under running water or immersed into any liquids 5.3 Cleaning the shoulder strap Prior to use the device in another patient the shoulder strap must be exchanged or hand washed at max. 40 C with soap sud (cleaning agent). 18

19 5.0 Cleaning and care 5.4 Recommended disinfectants for surfaces Disinfectant Ingredients (in 100 g) Manufacturer Green & Clean SK Di alkyl dimethyl ammonium chloride Alkyl dimethyl ethyl benzyl ammonium chloride Alkyl dimethyl benzyl ammonium chloride < 1 g < 1 g < 1 g Metasys, Rum (Austria) Dismozon pur (granulate) End of product 12/2014 Dismozon plus (granulate) Kohrsolin FF (Application concentrate) Kohrsolin extra (Application concentrate) Bacillol 30 Foam magnesium monoperoxyphthalat Hexahydrate magnesium monoperoxyphthalat Hexahydrate glutaral benzyl-c12-c18-alkyldimethylammoniumchloride didecyldimethylammoniumchloride (ethylendioxy)dimethanol glutaral didecyldimethylammoniumchloride ethanol propan-2-ol propan-1-ol N-Alkylaminoprpylglycin 80 g Bode Chemie, Hamburg 95,8 g Bode Chemie, Hamburg Any cleaning and disinfectant agents with the above mentioned ingredients are also used for cleaning the vacuum device. Discolouration may result if disinfectants containing aldehydes and amines are used on the same object. 5 g 3 g 3 g 14,1 g 5 g 8 g 14 g 10 g 6 g < 1 g Bode Chemie, Hamburg Bode Chemie, Hamburg Bode Chemie, Hamburg Perform pentakalium-bis(peroxymonosulphate)-bis(sulphate) 45 g Schülke & Mayr, Norderstedt SaniCloth Active didecyldimethylammoniumchlorid < 1 g Ecolab, Düsseldorf Incidin Active Peracetic acid < 1 g Ecolab, Düsseldorf Mikrozid Sensitive Wipes Mikrobac Tissues benzyl-c12-16-alkyldimethyl, chlorides didecyldimethylammonium chloride benzyl-c12-14-alkyl [(ethylphenyl)methyl]dimethylammonium, chlorides benzyl-c12-c18-alkyldimethylammoniumchloride didecyldimethylammoniumchloride 0,26 g 0,26 g 0,26 g < 1 g < 1 g Schülke & Mayr, Norderstedt Bode Chemie, Hamburg 5.5 Hygiene plan What How When Notes C D S After each procedure Daily Weekly Monthly After each patient Negative pressure X X X Manual wipe cleaning device X X X Manual wipe disinfection Canister X Single use product -> not suitable for reprocessing exchange after use Shoulder strap X X X At 40 C handwash Dressing Kit X X Single use product -> not suitable for reprocessing exchange after use C= Cleaning, D= Disinfection, S= Sterilisation 19

20 6.0 Maintenance and service 6.1 Basic information Maintenance, repairs and period tests may only be carried out by persons who have the appropriate technical knowledge and are familiar with the product. To carry out these measures the person must have the necessary test devices and original spare parts. ATMOS recommends: work should be carried out by an authorized ATMOS-service partner. This ensures that repairs and testing are carried out professionally, original spare parts are used and warranty claims remain unaffected. Carry out an inspection according to the manufacturers specifications every 24 months (Germany: safety check according to 6 Medical Device Operator Ordinance). This check should also include a check of the battery capacity. Further regular maintenance work is not required. It is understood that the vacuum unit and its application parts are regularly and thoroughly cleaned and disinfected, and that it is operated in accordance with the instruction manual. Please observe any national and international regulations applicable for your institution 6.2 Repairs The following problems may require repairs at the manufacturer or an authorised service partner. Please contact the manufacturer or authorised service partner by telephone before sending the unit. Liquids entered into the vacuum unit; Significant decrease of battery capacity; Sudden occurrence of abnormal displays on the screen; Sudden occurrence of abnormal noises; Operational faults or malfunctions that cannot be remedied using the measures as stated under Remedy of operational faults and malfunctions. 6.3 Handling of rechargeable batteries Rechargeable batteries are wear parts with a limited lifetime. Under optimal condition of use, rechargeable batteries are usually worn after approx. 500 charge cycles, and should then be replaced. Handling of the device, including the batteries, significantly affects lifetime of the batteries. Nonobservance of the following recommendations may significantly decrease lifetime. Always store device with batteries at a cool and dry place (room temperature C); Always store device with batteries at a charge status of 20-40%; Due to self-discharge, the batteries should be recharged every month; batteries installed in the device should be recharged every 4-5 months; Never cover the device; never expose the device to direct sunlight; and never charge, operate or store the device in close vicinity to heaters; When charging the battery at high environmental temperatures, the capacity of the batteries is not fully usable; When operating the vacuum unit at low environmental temperatures, the capacity of the batteries is not fully usable; Always charge the batteries using the respective charging equipment. Overcharging will destroy the batteries Attention Using other charging equipment may result in risk of explosions. 6.4 Exchange of accumulators The accumulators may only be exchanged by ATMOS or an authorized service partner. Measures when sending in the vacuum unit: If the vacuum unit is to be sent in to the manufacturer or an authorised service partner after respective consultation with such manufacturer or authorised service partner please ensure the following: Please send in the device complete with charger and mains cable (see scope of delivery). Removal of any single-use and/or consumables; Thorough cleaning and disinfection; Air-tight packaging; Accompanied by a detailed error description. 20

21 7.0 Trouble-shooting Description Possible error Troubleshooting Device cannot be switched on Battery cannot be recharged, mains symbol is not shown although the device is connected to the mains. Battery is fl at Tube blocked Automatic shutdown Battery is empty Defective mains cable or the mains cable is not properly connected to the device Power supply or internal battery is defective Battery is almost discharged Kink in the tubing system Blockage in the connections Battery is dead Therapy not started Connect mains cable for recharging the battery, see battery charging status on the left of the display Check mains cable Please inform the ATMOS service or an authorized service partner. Connect the device to the mains supply, battery is recharged, battery charging status is shown on the display on the left Remove the kink Check connections resp. exchange the canister Connect the device to the mains supply, battery is recharged, battery charging status is shown on the display on the left Switch on pump Canister full Leakage Battery unusable Device is hot Device is overheated WATCH Dog Jumper... Wound dressing has a leakage Connection between canister and device has a leakage Pump does not work Liquid in the device Service life of the battery is reached WATCH Dog Jumper not set Exchange canister Check wound dressing for any leakage if need be exchange the dressing Check connection between device and canister, if need be replace canister Please inform the ATMOS service or an authorized service partner. Switch on the device without the canister and start the therapy. Surpress the error message and run the device until the next error message apears. Subsequently conduct an effi ciency control (device with canister) a) device reaches the target vacuum and can be used again by the patients b) device does not reach the target vacuum. Please inform the ATMOS service or an authorized service partner. Please inform the ATMOS service or an authorized service partner. Please provide for suffi cient ventilation of the room Please inform the ATMOS service or an authorized service partner. Please inform the ATMOS service or an authorized service partner. 21

22 8.0 Accessories, consumables and spare parts REF Accessories Shoulder strap Device bracket Consumables Secretion canister 300 ml Secretion canister 800 ml VivanoMed Foam Kit S VivanoMed Foam Kit M VivanoMed Foam Kit L VivanoMed Foam Kit XL VivanoMed Foam Kit Round VivanoMed Foam Kit Thin VivanoMed Abdominal Kit Hydrofilm, 20 x 30 cm Hydrofilm, 10 x 12,5 cm VivanoMed Foam L VivanoMed Foam M VivanoMed Foam S VivanoTec Port small VivanoTec Port VivanoTec Y-Connector ATMOS Green & Clean SK ATMOS Green & Clean MK Spare parts 2 pole mains cable Charger Strap hook right Strap hook left

23 9.0 Technical specifications Voltages V~, 50/60 Hz IEC socket IEC320, type C 8 Power consumption max. 1.5 A Power input max. 50 W Charger Manufacturer: GlobTek, Inc. Model: GTM T2 Direct current voltage 12 V DC +/- 2 %, max. 5 A via cable,1.2 m length with plug 5.5 x 2.5 x 11 mm, alternatively via car cable from the cigarette lighter Rechargeable battery, built-in Lithium-ionic, 14.4 V nominal, 2250 mah Operation time Pump Flow Negative pressure Control of negative pressure Display Operating conditions Data memory Intermit mode Earth leakage current Ambient conditions Transport and Storage Ambient conditions Operation Dimensions HxWxD Weight: - Negative pressure unit (without canister) - Secretion canister 300 ml - Secretion canister 800 ml - Power supply and mains cable Charging time approx. 2.0 h, at ambient temperatures of 20 C (temperatures >25 C increase charging period), automatic switchover to trickle charging, operation up to 16 h at 80 mmhg with 0.4 l/min leakage, capacity indication on the display, continuous operation during mains operation Membrane pump, 1 pump head max. 4,5 l/min Freefl ow (without fi lter, damper or tubes) max. 500 mmhg (pump performance at sea level), however limited mechanically and by electronic control Electronically controlled, max. 250 mmhg, min 20 mmhg in steps of 5 mmhg, secretion canister must be connected for precise vacuum control Graphic display, colour, with background lighting, with adaptation to ambient lighting conditions and automatic switch off (energy saving mode) Continuous or intermittent, operation can be selected, simultaneously battery recharging and operating possible Internal memory for therapy data: 4MB Period max. vacuum: Range between 1 min - 10 min Period min. vacuum: Range between 1 min - 10 min Setting range min. vacuum between 20 mmhg mmhg* Setting range max. vacuum between 40 mmhg mmhg* *The set minimum vacuum value between high and low is 20 mmhg Default: High = 3 min and 120 mmhg; Low = 3 min and 20 mmhg max. 0,5 ma C % air humidity without condensation at air pressure hpa C % air humidity without condensation at air pressure hpa 164 x 206 x 95 mm without secretion canister depth with 300 ml canister: max. 115 mm depth with 800 ml canister: max. 153 mm 1.20 kg 0.16 kg 0.18 kg 0.50 kg Period tests Inspection according to the manufacturers specifi cations every 24 months (Germany: safety check according to 6 Medical Device Operator Ordinance). Protection class (EN ) Device: II Charger: II Degree of protection (The application part of the suction device is the hose-canister-system.) type BF Type of protection IP 33 Classifi cation acc. to Appendix IX EC Directive 93/42/EEC IIa CE marking CE 0124 UMDNS code suction device, Wound Issue of Technical Specifi cations:

24 10.0 Disposal When the device is operated according to the operating instructions it has an expected service life of 5 years. It is assumed that a regular thorough cleaning and disinfection of the negative pressure system and the application parts is performed as well as the correct operation of the device according to the operating instructions. Any possible contamination of the negative pressure device caused by wrong operation respectively non-observance of the operating instructions cannot be excluded. The ATMOS S 042 NPWT is not comprised of any hazardous materials. Device and accessories must be decontaminated prior to disposal as secrection residuals may lead to danger. The materials of the housing can be recycled completely. The materials are to be separated carefully. Please observe national valid rules for disposal of single-use and consumable products. Pay attention to country-specifi c regulations for disposal (e. g. waste incineration). Disposal within the EC The device described above is a high-quality medical product with a long service life. After its life cycle it must be disposed of professional. According to the EC directives (WEEE and RoHS) the device may not be disposed of in domestic waste. Please observe existing national laws and rules for disposal of old devices. Disposal within the Federal Republic of Germany In the Federal Republic of Germany the law for electrical devices (ElektroG) rules the disposal of electrical devices. It must be assumed that those suction devices could be contaminated. Therefore, this type of device is excluded from the law for electrical devices. In order to guarantee a proper disposal of your old device, please either pass on your old device to your specialised dealer or send it directly to ATMOS MedizinTechnik for a professional disposal. Prior to disposal respectively before transport all secretion containers and tubes must be removed. The device surface must be disinfected. 24