These operating instructions are valid from software version 1.3.

Transcription

1 Operating Instructions ATMOS S 042 NPWT English These operating instructions are valid from software version 1.3. GA1GB Index: 24

2 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.de 2

3 Table of contents 1.0 Introduction Notes on operating instructions Intended use (indication) Function Explanation of pictures and symbols Scope of delivery Transport and storage For your safety Special precautionary measures Setting up and starting up Device overview Buttons and symbols Prepare and assemble vacuum unit Charging the battery Connection and removal of shoulder strap Attachment and removal of secretion canister Connecting/removing the vacuum unit with the wound dressing set Attachment of the universal bracket (Accessories) Attaching/removing the vacuum unit at/from the universal bracket Operation Basic functions Switching the vacuum unit on and off Setting the negative pressure Starting/interrupting the therapy Switching the intermittent mode on and off Key lock Selecting the language Basic settings Brightness Day/Night Mode Warning messages Battery discharged Hose blocked Secretion canister full Leakage Service required Negative pressure 50 mmhg Battery service life exceeded Automatic switching off Period tests Cleaning and care General advice Cleaning of the device surface Cleaning of the shoulder strap Recommended disinfectants Hygienic plan Maintenance and service General advice Repairs Handling of batteries Exchange of batteries Sending in the device Troubleshooting Accessories, consumables and spare parts Technical data Disposal Notes on EMC Guidance and manufacturer's declaration - electromagnetic emissions Guidance and manufacturer's declaration - electromagnetic immunity Recommended safety distance between portable and mobile RF Communications equipment and the ATMOS S 042 NPWT For your notes... 39

4 1.0 Introduction 1.1 Notes on operating instructions These operating instructions are valid from software version 1.3. 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-times. This 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. Reproduction, even partial, is only permitted with written permission from ATMOS. These operating instructions must always be kept available near the device. Care and period tests 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 period tests 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 Appendix I of the 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 A safe function of the system as well as the conformity with the directive 93/42/ EEC is only guaranteed when the secretion canister provided by the manufacturer is used. 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 use (indication) Main function: Generation of a controlled negative pressure on an acute or chronic wound. Medical indications / application: Acute and chronic wounds. 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. 4

5 User profile: Doctors, medical auxiliaries without restrictions. Patient groups: Patients of all ages with and without restrictions. Application organ: Chronic and acute wounds on the skin which do not close by primary wound healing. Application time: Under normal conditions for a continuous application over a period of more than 30 days. Application site: Suitable for application in clinics, medical fields and home environment. The application of the negative pressure device may only be conducted under physicians instructed and by medically trained staff. Contraindications: Contraindications exist by patients with malignant tumour wounds (non enteric fistulas) which have not yet been examined, osteomyelitis or necrotic tissue. The ATMOS S 042 NPWT must not be applied to exposed nerves, anastomotic areas, blood vessels or organs. The negative pressure device 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). The product is: active Sterility: Secretion canister system is sterile. Single-use product/reprocessing: Secretion 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 diaphragm pump. During operation the pump creates a vacuum in the wound dressing, the hose 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 performance feature is the regulation (in the normal case) and the limitation (in the 1st fault) of the maximum possible negative pressure of the pump to approx mmhg. 5

6 1.4 Explanation of pictures and symbols Short cuts / symbols contained in these operating instructions Please read, important information General information Move, plug... in this direction 2 This product is not re-sterilizable. Numeration Turn, shift... in this direction Graphic symbols contained in these operating instructions Warning, special diligent notice! Professional disposal Symbols ATMOS S 042 NPWT SN Serial number Observe operating instructions! REF Order number Observe operating instructions! Manufacturing date Manufacturer The CE sign shows that this product meets the appropriate requirements of the EC Directives. 1.5 Scope of delivery IP33 Application parts type BF Protection class II Type of protection Attention! Prior to dispatch, the ATMOS S 042 NPWT was subjected to an extensive functional test and was carefully packed. Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt (see delivery note). Vacuum unit Battery recharging unit Operating Instructions Shoulder strap Mains cable 1.6 Transport and storage The device may only be transported in a upholstered and protective shipping box. Please note down and immediately report any damages which occurred during shipping. After the transport of the unit in temperatures below 0 C or prior to first start up it should be kept at room temperature for at least six hours. If the device is not acclimatized it may not be used as damage to the diaphragms of the pump could occur. 6

7 2.0 For your safety General information The ATMOS S 042 NPWT was produced in accordance with IEC! /EN and with VDE safety class ll. It may only be connected to a properly installed earthed wall socket. Dispose of wrappings accordingly. Please observe national regulations! ATMOS is not liable for personal injury and damage to property if For your safety -- no original ATMOS parts are being used, -- the advice for use in these operating instructions is not being observed, -- assembly, new settings, alterations, extensions and repairs have been carried out by personnel not authorised by ATMOS. During operation, the user is obliged to regularly check the vacuum unit for proper function. In the unlikely event of failure of the vacuum unit, the user must take precautions to continue the treatment of the patient 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. Dangers for users, patients and third parties Protect yourself against an electric shock. Power cables, accessories and access cables need to be checked for defects prior to setting up the device. Damaged cables must 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 power cable. The device does not have a power switch. Ensure that the power supply unit is easily accessible and can be disconnected from the power supply at all times. To disconnect the device from the mains supply, first remove the plug from the wall outlet. Then disconnect the connection line from the device. Never touch plug or line with wet hands. Do not modify the device without permission of 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 power cable, secretion hose and shoulder strap out of the reach of children. You should regularly check where these items are located. Confirm therapeutic success! ATMOS always recommends having a replacement device ready to hand. So you can continue the therapy even in the event of equipment failure. 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, exudative or acute enteric fistula wounds and with fresh flaps/transplants. 7

8 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 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. Depending on the negative pressure chosen, location and course of the hose, a secretion column in the hose can cause the negative pressure in the wound to not correspond to the selected value. Therefore, always place the vacuum unit at the same level or lower than the patient. For negative pressure values 50 mmhg, possible hose blockages in the hose system can not be detected. Thus check the wound dressing and entire hose system at regular intervals! How frequently the wound dressing and the hose system need to be checked 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 hose by regularly checking the hosing system and its connections for leakages and kinks. The control panel must be clearly visible and accessible for the operator. Modifications to the therapy settings on the device may only be conducted by health care professionals. Prior to start up the device, the user must verify correct functioning of the optical and acoustic display. Avoid the risk of the device falling to the floor. After a fall always contact the ATMOS Service or an authorized service partner. Change of dressing: Please observe the operating instructions for use of the applied wound dressing sets. Regularly check the filling level of the secretion canister to ensure problem-free operation of the vacuum unit. If the maximum filling level is achieved, please replace the secretion 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. 8

9 Risk of infection! The device should always be used in vertical position.! Prior to use please check the packing of the sterile product, the secretion canister and the vacuum hose on any damage. Do not use damaged secretion canisters. Repeated reuse of components which are marked with a 2 is forbidden. In case of repeated reuse these components lose For your safety their function and there is a high infection risk. No secretion may enter the device. If secretion has penetrated the device, it may not be operated again until it has been checked by the customer service centre. The removal of the canister from the device during the therapy may only be performed by trained professionals. Danger of explosion! The ATMOS S 042 NPWT is not designed for use in explosion-hazardous areas and in oxygen rich environments. Explosion-hazardous areas may be caused by the use of flammable anaesthetics, skin cleansing products and skin disinfectants. Avoid damage to the device. Please observe the ambient conditions stated in the technical data (chapter 9.0). 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 influence 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. Do not allow any disinfectant to get into the unit. If disinfectant has penetrated the device, then it must be dried thoroughly and subsequently an efficiency control must be conducted. If the desired target vacuum is reached then the device may continue to be used. If not it may not be operated again until it has been checked by the customer service centre. Before connecting the device it needs to be checked whether the requested mains voltage of the device matches the mains voltage of the mains power supply. Never place the device directly beside other devices. Do not stack the device! After the transport of the unit in temperatures below 0 C or prior to first start up it should be kept at room temperature for at least six hours. If the device is not acclimatized it may not be used as damage to the diaphragms of the pump could occur. 2.1 Special precautionary measures Special precautionary measures are indicated for patients with acute bleeding, 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 sufficiently 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. By 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. 9

10 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 For your safety 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 have knowledge in the field of special medical applications which the ATMOS S 042 NPWT was designed for. 10

11 3.0 Setting up and starting up 3.1 Device overview Front side Touch screen On/off button Charging plug connector Secretion canister (not included in the scope of delivery) Secretion canister release button 2 Rear side Secretion canister connections Carrying strap hinge Type plate Canister guide USB connectors (no function for users) 9 Secretion canister Bacterial filter 12 Canister guide The hose must not be clamped! Do not use clamps! Because of EP B1 valid in AT, BE, CH, DE, DK, ES, FR, GB, GR, IE, IT, LI, LU, MC, NL, PT, SE. 11

12 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 Start button When touching this button for two seconds the vacuum unit can be switched on and off. Starts therapy. Stop button Stops therapy. Menu button For calling up submenus. Plus button For increasing the displayed values. Int Cont mmhg Min. Minus button Intermit button Continuous button Intermittent menu Save/Back Up For decreasing the displayed values. For activation of the intermittent vacuum treatment. When activated it is framed green. For activation of the continuous vacuum treatment. When activated it is framed green. Touch this button to access the intermittent menu. Here you can set the intermittent parameters for optimisation of therapy. When activated it is framed green. 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. Down Close This button is used to scroll downwards in menus. This button is used to close the warning window and to suppress the alert. 12

13 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 3.3 Prepare and assemble vacuum unit Charging the battery Prior to first start up of the ATMOS S 042 NPWT the battery must be fully charged. Only the battery recharging unit supplied by ATMOS should be used. The vacuum unit should be recharged in a cool place without direct solar irradiation. At ambient temperatures above 25 C the charging time could be prolonged drastically. Improper use of the device may lead to serious damage. Defects which occur due to improper handling of the device are not covered by the guarantee. Connect the plug of the battery recharging unit to the charging connector of the vacuum unit. Connect the battery recharging unit with the supplied country specific power cable. Plug the mains plug into the socket. The vacuum unit then displays the battery charging status on the screen. The symbol changes. When the battery is fully charged (the symbol no longer changes) remove the mains plug from the socket. After that remove the charging plug from the charging socket of the vacuum unit. If the charging status of the battery is low, then the vacuum unit will raise an alert and the screen with display a warning window (see chapter Warning messages). If the battery is too low for further operation the vacuum unit switches off automatically. 13

14 3.3.2 Connection and removal of shoulder strap 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 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. 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. Unlocking the negative pressure unit for removal 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 with the snap link. Depending on the negative pressure chosen, location and course of the hose, a secretion column in the hose can cause the negative pressure in the wound not to correspond to the selected value. Therefore, always place the vacuum unit at the same level or lower than the patient. 14

15 3.3.3 Attachment and removal of secretion canister 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. Prior to use please check the packing of the sterile product, the secretion canister and the vacuum hose on any damage. Do not use damaged secretion canisters. Attachment of secretion canister Carefully remove the sterile secretion canister from the peel packaging. Ensure that the attached hose does not fall onto unsterile ground. Now place the canister - with a slight incline - into the guide pins of the device 13. Tilt the secretion canister in 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 Disconnect the secretion canister as described in the chapter Connecting/removing the vacuum unit with the wound dressing set. Press the release button (blue) at your vacuum unit and remove the secretion canister in a slightly inclined position. Correctly dispose of the secretion canister. Please observe national disposal regulations Connecting/removing the vacuum unit with the wound dressing set The ATMOS negative pressuresystem has a double lumen suction hose system to prevent blocking of the suction hose. Ensure that the connections are always correctly connected in order to avoid faults. Connecting Connect the hose ends of the canister and the wound dressing kit with each other. The hose must not be clamped! Do not use clamps! Because of EP B1 valid in AT, BE, CH, DE, DK, ES, FR, GB, GR, IE, IT, LI, LU, MC, NL, PT, SE. 15

16 Removal Press the release button of the hose connector laterally and keep it pressed. Now pull the two ends apart. 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 hose must not be clamped. Please do not use any clamps Attachment of the universal bracket (Accessories) Depending on the negative pressure chosen, location and course of the hose, a secretion column in the hose can cause the negative pressure in the wound to not correspond to the selected value. Therefore, always place the vacuum unit at the same level or lower than the patient. Turning the 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. Pull the fixing pin from the fixing at the bottom side of the stand holder. Turn the holder clamp until the fixing pin clicks into place at the next fixing. Ensure that the fixing pin is correctly clicked into place before attaching the vacuum unit on top. 16

17 Attaching the holder clamp Turn the turning knob of the holder clamp counter-clockwise until the clamp can be attached to the desired fixture. Turn the turning knob clockwise to fix the holder clamp. Ensure that the stand holder is firmly attached to the desired fixture Attaching/removing the vacuum unit at/from the universal bracket 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. 17

18 4.0 Operation 4.1 Basic functions Switching the vacuum unit on and off Switching on the vacuum 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. Confirm your entry with in order to return to the main screen. 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. For negative pressure values 50 mmhg, possible hose blockages in the hose system cannot be detected. Thus check the wound dressing and entire hose system at regular intervals How frequently the wound dressing and the hose system need to be checked depends on the patient as well as the wound. Observe the instructions from the attending physician. With negative pressure values 50 mmhg, it is physically impossible to transport a secretion column over a higher height difference. Therefore, never place the negative pressure unit higher than the patient to prevent sagging hoses Starting/interrupting the therapy 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. To interrupt therapy, to change the secretion canister or to finish therapy, touch the key. Finally remove the secretion canister according to chapter Attachment and removal of the secretion canister and replace it with a new secretion canister. Start the therapy again by pressing the key. If the therapy is not restarted then the device will switch off automatically after 30 minutes (see chapter 4.2 Warning messages ). 18

19 4.1.4 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. In the intermittent mode the difference between the set vacuum values must be at least -20 mmhg. A smaller difference is prevented by the negative pressure unit. Switching the intermittent mode on To switch on the intermittent mode press the Int key. The key appears on the screen. This key indicates the mmhg Min. set values of the intermittent mode and is framed in green. Change values To adapt the preset values touch the You reach the intermittent menu key. mmhg Min. 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. Now touch the or key to set the desired value. To save the newly set values touch the key. 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 Key lock The ATMOS S 042 NPWT is equipped with an automatic key lock. 1. Automatic activation of the key lock If no adjustments are made to the settings on the screen over a period of one minute then the key lock is automatically activated. This prevents accidental operation of the device. The symbol appears in the display. When the key lock is activated the display turns black after 5 minutes. 2. Manually activate the key lock The key lock can be manually activated after all the therapy values are set and the therapy is started. When the symbol blinks you can activate the key lock. Press the symbol to activate the key lock. When the key lock is activated the display turns black after 5 minutes. 19

20 sym- 3. Unlock the key lock Briefly touch the screen. The screen is activated when the bol appears and blinks. Touch the symbol. The symbol appears and blinks. Touch the symbol. As soon as the symbol blinks the key lock is deactivated. If you do not touch both the symbols and within 6 seconds the key lock remains activated. Now you must touch the screen once again so that the symbol appears Selecting the language Various languages can be set on the ATMOS S 042 NPWT. Proceed as follows: Press the key to reach the submenu. Select the field Language. Enter the language selection menu. Select the desired language here by touching the screen. A tick appears next to the selected language. To save the settings touch the key Basic settings Touch the key to reach the submenu. Select the field Basic settings. You will be asked whether you wish to return to the basic settings. Press Yes to return to the basic settings. Press No to cancel. The set language is not changed by returning to Basic settings. 20

21 4.1.8 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. Now set the desired value with the and keys. To save the settings touch the key. The screen reacts with a delay of two seconds Day/Night Mode The negative pressure unit has a day/night mode, the device adjusts automatically to the environmental lighting. During battery operation During battery operation the screen turns black after 5 minutes. Under low ambient light conditions display has dark background illumination. During mains operation If the device is connected to the mains power and the room brightness is low, the background screen in the display becomes dark. 21

22 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. After 5 minutes 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 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. For negative pressure values 50 mmhg, possible hose blockages in the hose system cannot be detected. Thus check the wound dressing and entire hose system at regular intervals How frequently the wound dressing and the hose system need to be checked depends on the patient as well as the wound. Observe the instructions from the attending physician. With negative pressure values 50 mmhg, it is physically impossible to transport a secretion column over a higher height difference. Therefore, never place the negative pressure unit higher than the patient to prevent sagging hoses Battery discharged The warning window (picture Battery discharged ) appears if the remaining operating time is less than one hour. Please connect the power supply unit as quick as possible. By touching the key this warning message can be suppressed for 5 minutes. The therapy can be continued unhindered. If the message is ignored, the negative pressure unit switches off automatically in order to protect the battery (see Chapter Automatic switching off ) Hose blocked The error message (picture below) appears if the negative pressure unit detects a blockage in the canister or hosing system. The following causes can trigger the error message: Kinks in the hosing system: Store the hose in such a way that kinks cannot 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. If the fault cannot be rectified by way of the above measures, the secretion canister should be changed. 22

23 4.2.3 Secretion canister full The following causes can trigger the error message: Secretion canister full: Exchange the secretion canister. Blockage of the bacterial filter in the secretion canister: If the bacterial filter has become moist with secretion, it becomes blocked. Exchange the secretion canister. By touching the key this warning message can be suppressed for 5 minutes. In order to prevent blockage of the bacterial filter make sure that the negative pressure unit is set up in stable position Leakage 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 canister is firmly connected to the negative pressure unit. 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 Service required This error message will be triggered if there is any damage to the pump. The negative pressure unit may no longer be applied and must be checked by the service Negative pressure 50 mmhg For negative pressure values 50 mmhg, possible hose blockages in the hose system cannot be detected. Thus check the wound dressing and entire hose system at regular intervals! How frequently the wound dressing and the hose system need to be checked depends on the patient as well as the wound. Observe the instructions from the attending physician. Never place the negative pressure unit higher than the patient and prevent sagging hoses. This warning message can be closed by touching the key and only reappears when the therapy is started again. 23

24 4.2.7 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. 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 battery replaced by the manufacturer as soon as possible Automatic switching off If a power supply unit has not been connected, in spite of repeated "Battery discharged" warning messages, the negative pressure unit switches itself off automatically after 30 minutes. The negative pressure unit can only be switched on again once a power supply unit has been connected, thereby recharging the battery Period tests A period test is required every two years. This will be displayed on the vacuum unit. This warning message can be closed by touching the key and only appears again when the negative pressure unit is restarted. 24

25 5.0 Cleaning and care 5.1 General advice Handling of the negative pressure unit determines to a large extent its reliability and safety. The hygiene measures are necessary measures for the protection of patients and users, and to maintain functional reliability of the vacuum unit. Clean and disinfect the surface of the negative pressure unit acc. to the procedure which applies to other electronic non-submersible medical products. Prior to cleaning please remove the power cable, power supply unit and charging plug from the device. The described action relating to cleaning and disinfection resp. sterilisation do not substitute the relevant instructions which must be adhered to prior to operation! Some disinfectants could cause discolouring to some of the plastic parts. Prevent liquids from penetrating the device. Please observe the operating instructions for use prescribed by the manufacturers of disinfectants. Pay attention regarding their concentration suitability for use and the contact time. Do not use -- Disinfectants which contain organic or inorganic acids or bases as they could cause corrosion damage. -- Disinfectants containing chloramides or phenol derivatives, since these may cause stress cracks in the material used for the housing of the unit. Always wear disposable gloves for any work you perform. For disinfection all the surface disinfectants which are stated in chapter 5.4 Recommended disinfectants are suitable. Prior to cleaning the device please remove and dispose of all disposable parts like secretion canister, dressing and hoses. When the device is used on another patient, all parts which come into contact with the suction material must be disposed of (secretion canister, hoses and dressing kits). We recommend that you always document all maintenance work and exchange of parts in writing. 5.2 Cleaning of the device surface Prior to using the device on a new 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 being used by the same patient the surface should still be cleaned at least once every week with a damp (not wet) cloth and afterwards be disinfected with a surface disinfectant. The device should never be autoclaved, rinsed under running water or immersed into any liquids! 5.3 Cleaning of the shoulder strap Prior to using the device on another patient the shoulder strap must be exchanged or hand washed at max. 40 C with soapy water (cleaning agent). 25

26 5.4 Recommended disinfectants Disinfectant Ingredients (in 100 g) Manufacturer Green & Clean SK Dismozon pur (Granulate) End of product 12/2014 Dismozon plus (Granulate) Kohrsolin FF (Application concentrate) Kohrsolin extra (Application concentrate) Bacillol 30 Foam Perform 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) magnesium monoperoxyphthalate hexahydrate 80 g Bode Chemie, Hamburg magnesium monoperoxyphthalate hexahydrate 95.8 g Bode Chemie, Hamburg glutaral benzyl-c12-c18-alkyldimethyl-ammonium chlorides Didecyldimethylammonium chloride (ethylenedioxy)dimethanol glutaral Didecyldimethylammonium chloride ethanol propan-2-ol propan-1-ol N-Alkylaminoprpylglycin Pentapotassium-bis(peroxymonosulphate)-bis(sulphate) 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 45 g Schülke & Mayr, Norderstedt SaniCloth Active Didecyldimethylammonium chloride < 1 g Ecolab, Düsseldorf Incidin Active peracetic acid < 1 g Ecolab, Düsseldorf Mikrozid Sensitive Wipes Mikrobac Tissues benzyl-c12-16 alkyldimethyl-, chloride; Didecyldimethylammonium chloride benzyl-c12-14-alkyl [(ethylphenyl)methyl]dimethyl-, chlorides benzyl-c12-c18-alkyldimethyl-ammonium chlorides Didecyldimethylammonium chloride 0.26 g 0.26 g 0.26 g < 1 g < 1 g Schülke & Mayr, Norderstedt Bode Chemie, Hamburg All cleaning and disinfectant agents with the above mentioned ingredients are also suitable for cleaning the vacuum unit. When using disinfectants containing aldehyde and amines at the same object colour changes may occur. 5.5 Hygienic plan WHAT HOW WHEN Details C D S after each application daily weekly monthly After each patient Vacuum unit Canister X X X Manual wipe cleaning X X X Manual wipe disinfection X Single use product -> not for reconditioning, change after use Shoulder strap X X X At 40 C handwash Dressing kit X X X C = Cleaning, D = Disinfection, S = Sterilization Single-use product -> not for reprocessing, change after use 26

27 6.0 Maintenance and service 6.1 General advice 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 manufacturer s specifications every 24 months. This check should also include a check of the battery capacity. The unit does not require any further maintenance. 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 may require repairs from the manufacturer or an authorized service partner. Prior to sending in the device, please contact your service partner by phone. Liquid has penetrated the vacuum unit. Significant decrease of battery capacity. Sudden occurrence of abnormal displays on the screen. Sudden occurrence of unusual noises Operational and functional disorders which cannot be resolved by means of the hints described in the chapter Troubleshooting. Measures when sending in the vacuum unit: If the vacuum unit has to be sent in for repair after consultation with the manufacturer or an authorized service partner, we ask you to observe the following: Please send in the device complete with battery recharging unit and power cable (see scope of delivery). Please remove all disposable parts and consumables. Thorough cleaning and disinfection Airtight packing Please enclose a detailed error description 6.3 Handling of batteries Rechargeable batteries are wear parts with a limited lifetime. Under optimal condition of use, lithium-ionic batteries are usually worn after approx. 500 charge cycles and should then be replaced. Handling of the device and the batteries significantly affects lifetime of the batteries. Non-observance of the following recommendations may significantly decrease lifetime. Always store device with batteries in 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 in a high ambient temperature, the capacity of the batteries is not fully usable. 27

28 When operating the negative pressure unit at low environmental temperatures, the capacity of the batteries is not fully usable. Always charge the batteries using the respective charging accessories. Overcharging will destroy the batteries. Using other charging accessories may result in risk of explosions! 6.4 Exchange of batteries The batteries may only be exchanged by ATMOS or an authorized service partner. 6.5 Sending in the device 1. Remove and properly dispose of consumables. 2. Clean and disinfect the product and accessories according to the operating instructions. 3. Place used accessories with the device. 4. Fill in the form QD 434 Delivery complaint / return shipment and the respective decontamination certificate. && This form is enclosed to each delivery and can be found at 5. The device must be well padded and packed in suitable packaging. 6. Place the form QD 434 Delivery complaint / return shipment and the respective decontamination certificate in an envelope. 7. Affix the envelope to the outside of the package. 8. Send the product to ATMOS or to your dealer. 28

29 7.0 Troubleshooting Description Possible causes Remedy Device cannot be switched on. Battery is completely empty. Connect the power cable to the device to recharge the battery, note that the progress can be checked in the upper left hand corner of the display. Battery does not recharge and charging symbol does not light up despite proper connection to the power cable. Power cable defective or not connected properly. Power supply or internal battery is defective Check the power cable. Contact the ATMOS service or a certified service partner. Battery discharged Battery almost empty. Connect device to the supply network. The battery is charged and the state of charge is indicated in the display. Hose blocked Kinks in the hosing system. Remove the kink. Automatic switching off Blockages at the connection points. Battery empty Therapy not started Check connections resp. exchange the secretion canister. Connect device to the supply network. The battery is charged and the state of charge is indicated in the display. Switch on pump. Secretion canister Exchange secretion canister. full Leakage Wound dressing has a leakage Check wound dressing for any leakage if need be exchange the dressing. Battery service life exceeded Device is hot Connection between secretion canister and vacuum unit has a leakage. Pump does not work Liquid in the device Service life of the battery is reached Check connection between vacuum unit and canister, if need be replace secretion canister. Contact the ATMOS service or a certified service partner. Switch on the device without the secretion canister and start the therapy. Suppress the error message and run the device until the next error message appears. Subsequently conduct an efficiency control (device with canister). a) device reaches the target vacuum and can be used again by the patient. b) device does not reach the target vacuum. Contact the ATMOS service or a certified service partner. Contact the ATMOS service or a certified service partner. Please ensure sufficient air ventilation. 29