Time saving with simple operation Height-adjustable arm Swivel range suction head Internal cable routing ergo vac LT Operating Manual Arm swiveling
Sales and Service Information mbnet Engineering GmbH has a network of customer service, sales and information centers. Ask the next mbnet Engineering GmbH sales representative for the local distributor nearest you. For a complete list of all sales and branch offices, please visit our website: www.mbnet.de. More information can also be obtained by writing to: info@mbnet.de. The ergo vac LT suction unit bears the CE-Label (IEC 60601-1, Class I, Type CF with defibrillation protection), which proves that the applicable basic requirements in terms of safety, function and labeling under EC Directive 93/42 Appendix I concerning medical devices have been met. The requirements relate to patients, users and third parties who come into contact with this device within the scope of its intended use. Date of issue: 30.10.2016 mbnet Engineering GmbH Kirschauer Strasse 37a D-02681 Callenberg Telephone +49 (0) 3592 34 83 0 Fax +49 (0) 3592 34 34 4 E-mail info@mbnet.de Website www.mbnet.de
Operating Manual ergo vac LT Table of Contents 1 Safety Instructions... 4 1.1 Operator Responsibility... 4 1.2 Organizational Measures... 4 1.3 Proper Use... 4 1.4 1.5 Contraindications... 4 Safe Operation... 5 1.6 Safe Handling of Electronics... 5 1.7 Operation with Other Devices... 5 1.8 Maintenance... 5 1.9 Warranty Provisions... 6 1.10 Safety Symbols and Pictograms... 6 1.10.1. Symbols Used in this Document... 6 1.10.2. Symbols Used on the Device... 7 2 Introduction... 8 2.1 Elements of Suction device... 8 2.1.1 Scope of Delivery... 8 2.1.2 Options... 8 2.2 Suction Electrode Leads... 8 2.3 Control Box with Control Panel... 8 2.4 Cable Arm... 9 2.5 Connections... 9 3 Operation... 10 3.1 Getting Started and Location... 10 3.2 On/Off... 10-11 3.3 Power Supply... 11 3.3.1 Displays for Mains or Battery Power... 11 3.3.2 Isolation from Power Grid... 11 5.4 Right Precordial (C4r)... 15 6 Application... 16 6.1 Operating Conditions... 16 6.2 Sequence of Taking a Reading... 16 7 Maintenance... 17 7.1 Visual Inspection... 17 7.2 Cleaning of Housing and Cables... 18 7.2.1 Cleaning Electrodes... 19 7.2.2 Cleaning Connecting Cables... 19 7.2.3 Approved Cleaning Agents... 19 7.2.4 Non-approved Cleaning Agents... 19 7.3 Disinfection... 20 7.3.1 Approved Disinfectants... 20 7.3.2 Non-approved Disinfectants... 20 7.4 Battery... 20 7.4.1 Charging the Battery... 20 7.4.2 Battery Disposal... 21 7.5 Inspection Report... 21-21 7.5.1 Replacement of Parts with Limited Service Life, every 3-5 Years... 22 8 Troubleshooting... 22 8.1 Frequent Problems... 22 8.2 Eliminating Electromagnetic Interference... 23 8.3 Warrant... 23 8.4 Parts and Consumables... 24-24 4 Controls... 11 4.1 Suction Levels... 12 4.2 Blowing out Air... 12 4.3 Cleaning... 12 5 Placement of Electrodes... 12 5.1 Basics... 12-13 5.2 Identification and Color Code for Electrodes... 13 5.3 Resting CG with 10-lead Patient Cable... 14 9 Technical Data... 24 9.1 Pump Module... 24 9.2 Patient Module... 25 9.3 System Cable... 25 9.4 Electrodes... 25 9.5 Cable Arm... 25 9.6 Safety Standards... 25 6
ergo vac LT Operating Manual 1 Safety Instructions 1.1 Operator Responsibility The device may only be used by qualified doctors or trained and medical staff. The responsibilities of the operational and maintenance staff must be determined by the operator. Ensure that the staff has read and understood the operating manual. This applies in particular to these safety instructions. Damaged or missing parts must be replaced immediately. The safety, reliability and functioning of the device can only be guaranteed if the prescribed maintenance intervals in the Maintenance chapter are observed. 1.2 Organizational Measures The unit may only be put into operation if its functions and the necessary safety precautions have been explained by a medical product advisor. Always keep the operating manual close to where the unit is being used. Make sure that it is always complete and legible. Observe operating and maintenance instructions. 1.3 Proper Use The unit is an ECG suction device and is operated in combination with conventional ECG devices. The device is suitable both for resting as well as stress ECG tests and is used for patients of both sexes and of all origins and ages (beneficial for patients 7 years and older, also depending on height). The device is suitable for use inside hospitals, cardiology centers, outpatient clinics and medical practices. The device can be safely used on patients wearing pacemakers. Always use the device according to the given technical specifications. The device is not designed for sterile or outdoor use. This unit is a CF type device. It is defibrillation-proof if the original mbnet Engineering GmbH suction lines are used. As a precautionary measure, the electrodes should be removed where possible prior to defibrillation. 1.4 Contraindications The device is not intended for sterile use. The device must not be used in explosive environments or in areas where flammable gases, for example anesthetics, are used. The device is not suitable for use directly at the heart. The device is not suitable for use in an MRI scanner. Page 4
Operating Manual ergo vac LT 1.5 Safe Operation Ensure that the staff has read and understood the operating manual and in particular these safety instructions. The housing of the device must not be touched during defibrillation. To ensure the safety of the patient, neither the electrodes (including neutral electrodes) nor the patient or persons touching the patient may coming into contact with conductive parts, even if they are grounded. Any changes, including those in performance, which may pose a safety hazard must be immediately reported to the person in charge. Only use the accessories and disposable parts supplied or recommended by mbnet Engineering GmbH. The use of third-party accessories or disposable parts may result in injuries, inaccurate information and / or damage of the equipment. 1.6 Safe Handling of Electronics Operating the device without proper grounding or with defective cables puts the life of the patient or the operator at risk! Therefore: The device must not be used if it is not properly grounded or the power cord is damaged and/or suspected to be damaged. Any damaged cable connections and power plugs must be replaced immediately. Electrical safety devices such as fuses must not be changed. Only use the specified type of fuse when changing fuses. 1.7 Operation with Other Devices If the device is part of a medical system, it must be ensured that only the original suction lines supplied by mbnet Engineering GmbH are connected to the device. Portable communication devices, HF radios and equipment bearing the symbol: (non-ionizing electromagnetic radiation) may impair the operation of this device. 1.8 Maintenance Electric shock hazard. Do no open the device. It does not contain any parts that can be repaired by the user. Maintenance work may only be performed by a qualified technician authorized by mbnet Engineering GmbH. Turn off and unplug the device before cleaning. Do not subject the device to high-temperature sterilization processes (such as autoclaving) or to electron beam or gamma ray sterilization. Do not use aggressive cleaning agents or abrasives. Under no circumstances must the device or the cables be immersed in a cleaning liquid. Page 5
ergo vac LT Operating Manual 1.9 Warranty Provisions Under the company GTC, your device carries a warranty on material and manufacturing defects. This does not include damage caused by carelessness or improper use. The warranty covers the free replacement of the defective part. Any liability for consequential damage is excluded. The warranty is null and void if unauthorized or unqualified persons attempt to repair the device. In the event of a defect, the damaged device must be sent to the nearest mbnet Engineering GmbH outlet or directly to the manufacturer. The manufacturer can only warrant the safety, reliability and functioning of the device if: the device is installed and any additions, readjustments or repairs are carried out by persons authorized by the manufacturer and the device and the approved components are used according to the manufacturer's instructions and the prescribed maintenance intervals according the Maintenance chapter were observed. We make no other warranties. mbnet Engineering GmbH assumes no guarantee for the commercial usability and suitability of the product or product components for a particular purpose. 1.10 Safety Symbols and Pictograms 1.10.1 Symbols Used in this Document The hazard levels are classified according to ISO 3864-2 standards. The following overview shows the safety symbols and pictograms used in this manual. For general safety instructions listed in this chapter. For electrical hazards, warnings or precautions in dealing with electricity. Notice of a possibly dangerous situation that could lead to property damage or system failure. Important or useful information. Reference to other instructions. Warning of an imminent danger that could cause serious bodily injury or death. Warning of a potentially dangerous situation that could cause serious bodily injury or death. Warning of a potentially dangerous situation that could lead to minor personal injury. Can also be used as a warning of material damage. Page 6
Operating Manual ergo vac LT 1.10.2 Symbols Used on the Device CF symbol protecting against defibrillation voltage. But it is only defibrillation-proof with the original mbnet Engineering GmbH patient cable. To be disposed of as electronic waste. Caution, consult accompanying documents. Manufacturer. Date of Manufacture. CE label. Follow manufacturer's instructions. Page 7
ergo vac LT Operating Manual 2 Introduction The ergo vac LT is an ECG suction device for recording heart potentials during resting and stress ECGs and sending the data to the ECG device. The built-in control panel allows for easy operation and efficient configuration of the device. 2.1 Elements of the Suction Device Overview Control box Control Cable Vacuum Hose Pump module Suction line Electrode elements Patient Cable 2.1.1 Scope of Delivery Standard Model Resting and stress ECGs Mains operation 2.1.2 Options Battery operation 2.2 Suction Electrode Leads The ten shielded, interference-free electrode lines are trouble-free and stand out by virtue of their low abrasion and high flexibility. 2.3 Control Box with Control Panel What makes the control box stand out is its optimal user ergonomics. It consists of a control panel, control electronics and defibrillation protection. The control panel features white and green backlighting as well as push buttons. The control panel is easy to operate and to clean. Page 8
Operating Manual ergo vac LT ON/OFF Control box Stop ECG Clean Suction power 2.4 Cable Arm The special feature of the cable arm consists of its hidden cable routing as well as its 300 movable arm. 2.5 Connections The unit may only be connected to the following devices: ECG devices that meet IEC 60601-1 standards. ECG monitors that meet IEC 60601-1 standards. The unit must not be connected to Class B ECG devices. Any connection to unauthorized hardware is at your own risk. It may also void the warranty. Page 9
ergo vac LT Operating Manual Fuse Pump Module Power Power Switch Vacuum Hose Control Cable The patient cable and leads meet the CF safety standard, i.e. they are electrically isolated and fully insulated, defibrillation-proof and suitable for intracardiac application. The unit only meets the CF standard with the original mbnet Engineering GmbH suction lines. 3 Operation 3.1 Getting Started Electric shock hazard. The device must not be used if it is not properly grounded or the power cable is damaged or suspected to be damaged. Location The device must not be stored or operated in a wet, humid or dusty area. It must also not be exposed to direct sunlight or heat from other sources. The device must not come into contact with acids or acidic fumes. The device must not be placed in the immediate vicinity of X-ray or diathermy devices, large transformers or electric motors. 3.2 On/Off The unit is switched on and off with the button. When pressing the ON button, the electrode can be sucked to the skin of the patient by applying light pressure with the fingers. Page 10
Operating Manual ergo vac LT Turn off the unit when not in use for a longer time. Never apply suction when the electrodes are in a cleaning fluid. When pressing the button, the suction pump creates a vacuum for about 5 seconds and then turns off automatically. 3.3 Power Supply 3.3.1 Displays for Mains or Battery Power The unit can be connected to the mains or be supplied from the built-in battery (option). In both modes the button on the control panel will light up. Battery Life (Option): Battery being charged: Recharging Times: The internal battery provides power for up to two hours of continuous use Should the battery charge level fall below 20%, the suction indicator will start to blink and indicate that the battery needs to be recharged. A completely depleted battery takes about 3.5 hours to fully charge (when power is off). If the device is switched on during charging, the charging time may be longer. The battery is charged when the device is connected to the mains. The device can remain connected to the power grid without causing damage to the device or battery. The device can remain connected to the power grid without risk for the battery. Battery recharging time if depleted: about 3.5 hours if the unit is not in use Charging time when in use: about 10 hours 3.3.2 Isolation from Power Grid To isolate the device and the power supply from the mains, pull the power plug. Page 11
ergo vac LT Operating Manual 4 Controls The controls are located on the front of the control box and control the entire suction system. 4.1 Suction Levels The system's suction lines can be individually adjusted for each patient using 5 suction levels. When the unit is turned on, it activates an average default level (about -150 mbar). The current suction level is indicated by the green LEDs on the control panel. The highest level is about -220 mbar and should only be used in extreme cases (a lot of body hair). The suction level must in each case be adjusted to the patient's skin type! The device must not be used if the skin is broken. Strong suction or long-term exposure to suction may result in hematomas! Particular caution is especially required with older patients. The operator of the unit should ask the patient how he or she feels! The electrodes should not be applied to the skin of the patient for more than 25 minutes. 4.2 Blowing out Air 4.3 Cleaning When pressing the button, the suction unit will be blown out with compressed air for about 5 seconds and then turned off automatically. When the system is in standby mode, it can blow out the air from the suction lines by pressing the cleaning button. The cleaning is stopped by pressing the button. The system then reverts back to standby mode. Never apply suction when the electrodes are in a cleaning fluid. 5 Placement of Electrodes Make sure that neither the patient nor the conducting parts of the patient connection or the electrodes (including the neutral electrodes) come into contact with other persons or conductive parts (even if they are grounded). 5.1 Basics To get good data, it is important to apply the electrodes with care (see placement positions on pages 13-15) and make sure that the electrodes make good contact. To obtain optimal signals and achieve the best quality possible when taking an ECG, the resistance between the skin and the electrodes must be kept as low as possible. For this reason, the following points should be observed: Page 12
Operating Manual ergo vac LT 1 Only use the electrode types recommended by mbnet Engineering GmbH. 2 To increase the conductivity and adhesion of the electrodes to the skin: 3 Check the electrode resistance. shave the areas of skin to which the electrodes are applied, if necessary. thoroughly clean these areas of skin with alcohol or water and soap. Let dry the skin thoroughly before applying the electrodes. 4 If the electrode contact is outside the tolerance: remove the electrode and use an abrasive cleaning pad or abrasive cleaning gel to remove the upper layers of the epidermis. Apply the electrode. 5 Ensure that the patient is warm and relaxed before you start the procedure. 6 After the procedure, remove the electrodes by pressing on the cleaning button. Clean the suction or vacuum electrodes according to the manufacturer's instructions. * The use of special abrasive cleaning gel is very effective in reducing the electrical resistance of the skin 5.2 Identification and Color Codes for Electrodes The color scheme of the electrodes in this chapter corresponds to Code 1 (IEC). Below you will find the corresponding color scheme in accordance with Code 2 (AHA). IEC AHA IEC Labels Color AHA Labels Color Extremities R L F red yellow green RA LA LL white black red Thorax according to Wilson C1 C2 C3 C4 C5 C6 white / red white / yellow white / green white / brown white / black white / purple V1 V2 V3 V4 V5 V6 brown / red brown / yellow brown / green brown / brown brown / black brown / purple Neutral N black RL green Page 13
ergo vac LT Operating Manual 5.3 Resting ECG with 10-lead Patient Cable Placement of Electrodes for Standard Readings C1 red C2 yellow C3 green C4 brown C5 black C6 purple R red L yellow N black green F With a child, it is sometimes difficult to place all electrodes. In this case, the electrode C4 can be placed on the right side of the thorax and the lead indicator setting can be programmed to V4r. IEC Labels AHA Labels Connecting ECG Patient Cable C1, red V1, red Fourth intercostal space, right edge of sternum C2, yellow V2, yellow Fourth intercostal space, left edge of sternum C3, green V3, green Halfway between C2 and C4 C4, brown V4, blue Mid-clavicular line, fifth intercostal space C5, black V5, orange Anterior axillary line, at the height of C4 C6, purple V6, purple Mid-axillary line, at the height of C4 L, yellow LA, black Left arm (resting ECG) R, red RA, white Right arm (resting ECG) F, green LL, red Left foot (resting ECG) N, black RL, green Right foot (resting ECG) Page 14
Operating Manual ergo vac LT 5.4 Right Precordial (C4r) The ACC/AHA guidelines recommend to examine all patients with myocardial infarction and inferior ST-segment elevation for signs of a possible RV ischemia or RV infarction; this examination is carried out with a right precordial C4r lead. C1 rot C4 brown C2 yellow C3 green C5 black C6 purple R rot L yellow N black F green IEC Labels AHA Labels Connecting ECG Patient Cable C1, white / red V1, brown / red Fourth intercostal space, right edge of sternum C2, white / yellow V2, brown / yellow Fourth intercostal space, left edge of sternum C3, white / green V3, brown / green Halfway between C2 and C4 C4, white / brown V4, brown / blue Fifth intercostal space to the right of the mid-clavicular line. C5, white / black V5, brown / orange Anterior axillary line, at the height of C4 C6, white / purple V6, brown / purple Mid-axillary line, at the height of C4 L, yellow LA, black Left arm R, red RA, white Right arm F, green LL, red Left foot N, black RL, green Right foot Page 15
ergo vac LT Operating Manual 6 Application Do not take an ECG until you have read and understood the safety instructions at the beginning of this operating manual. The device is a CF type device. When taking an ECG, ensure that neither the patient nor the conducting parts of the patient connection or the electrodes (including the neutral electrodes) come into contact with other persons or conductive parts (even if they are grounded). The device must not be used if the power cable is damaged or suspected to be damaged. 6.1 Operating Conditions The device is not suitable for continuous operation; switch off after use. High-frequency fields and radiation can affect the quality of ECG readings. The device can be operated under the following ambient conditions: Ambient temperature: between +10 C and +40 C Relative humidity: between 30 % and 75 % Air pressure: between 700 hpa and 1060 hpa 6.2 Sequence of Taking a Reading 1 Prepare the patient 2 Turn on the device and apply the electrodes 3 Ask the patient how he/she is feeling (check electrode suction level) 4 Determine and adjust suction level / the lower the level, the easier it is on the skin! Level 1 & 2: for smooth skin Level 4: for medium hairy skin Level 3: for slightly hairy skin Level 5: for very hairy skin 5 Take the reading 6 Turn off vacuum pump by pressing button; the electrodes will come off the patient on their own 7 The device automatically turns off after 10 seconds 8 (Optional) In case of prolonged stress tests and/or heavily perspiring patients, the system can blow out air by pressing the cleaning button 9 Clean the electrodes Page 16
Operating Manual ergo vac LT 7 Maintenance The device must be inspected at regular intervals (chapter 7.5). The results must be recorded in writing and compared with the values in the accompanying documents. Maintenance work not described in this chapter may only be carried out by qualified and authorized technicians. The following table provides information on the inspection intervals and the person(s) responsible for maintenance checks. The regulations in different countries may call for additional or different inspection intervals and tests. Interval Inspection & Tests Responsibility Before each use Visual inspection of the unit and ECG electrodes User Every 6 months Every 12 months Visual inspection of the unit (see page 21, 7.5 inspection report) - Cables and accessories - Power cable Functional tests in accordance with the instructions (see page 21, 7.5 inspection report) Safety check in accordance with Sect 6 MPBetreibV (Medical Devices Operator Ordinance) User Qualified personnel 7.1 Visual Inspection Visually inspect the device and connection cables for the following: Housing, device and power cable (no damage or cracks). Membrane keypad (no damage or cracks). Electrode cable insulation and connectors (no damage). No cracking, abrasion or wear of the connecting leads. Input/output connectors (no damage or cracks). In addition to the visual inspection, the device should be turned on and all functions on the control panel should be checked. This ensures: That the device is functioning properly. That the display is functioning properly. Any defective devices or damaged cables must be replaced immediately. Page 17
ergo vac LT Operating Manual 7.2 Cleaning of Housing and Cables Turns off and unplug the device before cleaning. Under no circumstances must the device be immersed in a cleaning liquid or subjected to sterilization with hot water, steam or air. Do not autoclave the device and accessories. Do not immerse the device in liquids. The use of other cleaning agents with high acid content, or which are otherwise unsuitable, may damage the device (causing cracks and wear of the plastic housing, among other things). Always follow the manufacturer's instructions regarding dilution of the cleaning agent. Do not use any of the following cleaning agents or similar agents: ethyl alcohol, ethanol, acetone, hexane, aggressive or abrasive powder or materials and cleaning agents that attack the plastic. The patient cable and other connection cables must not be subjected to severe mechanical stresses. To disconnect the electrodes, pull on the connector and not on the cable. To avoid damage, the cable should always be placed so that no one can trip over it and no trolley will run over it. When cleaning the device, make sure that all information and safety-relevant inscriptions on the device (be it labels, stickers or engravings) do not come off and remain legible. Check the device and accessories thoroughly before cleaning. Make sure that there is no damage and that the buttons and connections are working properly mechanically. Bend the cable carefully and check it for damage, excessive wear, exposed wires and bent connectors. Make sure that all connectors properly snap into place. To clean the device, only wipe the surfaces of the housing and the connecting cables with a damp (not wet) cloth. If necessary, grease and fingerprints can be removed with a noncorrosive household cleaner or a 70% alcohol solution. Wipe the equipment with a cloth dampened with an approved cleaning agent (see chapter 7.2.3) (the cloth should only be moist, not wet). Thoroughly wipe off any excess cleaning agent. Make sure that no liquid pools or gets into connectors, switches or gaps. Should some liquid nevertheless get into connectors, dry them with warm air and then check that the device is still working properly. 7.2.1 Cleaning Electrodes NEVER use metallic or sharp objects to clean the electrodes. These can be irreparably damaged. Page 18
Operating Manual ergo vac LT Make sure that the suction unit is working in cleaning mode when immersing the electrode in a cleaning liquid. Incorrect operation and sucking in cleaning liquid can cause irreparable damage to the device. When the suction cup is removed from the electrode element, make sure that the suction cup is seated straight on the electrode element and the inner seal lip is closed. Also ensure that hose attachment of the suction cup is not twisted or warped. Check the system for air tightness by conducting a short function test. Suction cups whose seal lips are not seated properly emit a clearly audible whistling sound. 7.2.2 Cleaning Connecting Cables 1 Check the cable for damage before cleaning. Carefully bend all parts of the cable and examine the cable insulation for cracks, damage or excessive wear, exposed wires and bent connectors. 2 Wipe the device with a cloth dampened with an approved cleaning agent (the cloth should only be moist, not wet); the approved cleaning agents are listed below. 3 Hold the cable with the cloth in the middle of the cable; wipe 20 cm of the cable with the cloth each time until the entire cable is clean. Never clean the cable over its entire length at one time, as this may cause damage to the cable insulation. 4 Thoroughly wipe off any excess cleaning agent. Make sure that no liquid pools or gets into connectors, switches or gaps. Should some liquid nevertheless get into connectors, dry them with warm air. 7.2.3 Approved Cleaning Agents 70% isopropyl alcohol neutral, mild cleaning agents all products intended for cleaning plastic 7.2.4 Non-approved Cleaning Agents Do not use any products containing the following: Ethyl alcohol Acetone Hexane Scouring powder Plastic-dissolving materials Page 19
ergo vac LT Operating Manual 7.3 Disinfection Disinfection eliminates certain bacteria and viruses. Please refer to the manufacturer's instructions. For disinfection, commercially available disinfectants for clinics, hospitals and medical practices can be used. Disinfect the device in the same way as described in the chapter on cleaning (see chapter 7.2). 7.3.1 Approved Disinfectants Isopropyl alcohol 70 % Propanol (70-80 %) Ethyl hexanol Aldehydes (2-4 %) Ethanol (70-80 %) All products suitable for ABS plastic 7.3.2 Non-approved Disinfectants Organic solvents Ammonia-based cleaning agents Abrasive cleaning agents 100 % alcohol, Virex, Sani-Master Sani-Cloth -, Ascepti -, Clorox wipes HB Quat Conventional detergents (e.g. Fantastic, Tilex etc.) Conductive solutions Solutions or products containing the following: Acetone Ammonium chloride Betadine Chlorine, wax or wax compounds Ketone Sodium salt 7.4 Battery No maintenance is required for the battery. Depending on use, the battery should be replaced about every 4 years or if the battery life falls significantly below 1 hour. As long as the device is not in use, you should make sure that the battery is not completely depleted. Should the device not be used for more than three months, the battery must be protected from complete discharge by recharging it. 7.4.1 Charging the Battery Should the battery charge level fall below 20%, the suction indicator will start to blink and indicate that the battery needs to be recharged. A completely depleted battery takes about 3.5 hours to fully charge (when power is off). If the device is switched on during charging, the charging time may be longer. Page 20
Operating Manual ergo vac LT The device can stay connected to the power grid without risk to the battery. 1 Connect the device to the power grid. 2 The button light will flash every 2 seconds. 3 Once the battery is fully charged, the button light will stay on. 7.4.2 Battery Disposal The battery must be brought to a recycling center in accordance with the relevant regulations of a country or sent back to mbnet Engineering GmbH. Danger! Risk of explosion! The battery must not be incinerated or treated as municipal waste. Danger! Acid-burn risk! Do not open the battery under any circumstances. 7.5 Inspection Report The operating manual must have been read prior to inspection Recommended inspection interval: every 6 months Serial Number: Test Results Date Visual inspection (external condition) housing intact electrode connection sockets undamaged Presence & condition of accessories ECG suction lines operating manual power cord Functional test Turn on device Suction level regulation Battery check power cord works battery indicator appears Comments: For intervals of repeat testing, see instructions of ECG manufacturer Inspection carried out by: * In case of error, please contact the service department of your hospital, your mbnet Engineering GmbH representative or the local customer service: (Name) (Telephone) Page 21
ergo vac LT Operating Manual 7.5.1 Replacement of Parts with Limited Service Life, Every 3-5 Years Internal battery Inspection Results Replaced Replace the internal battery if the battery life falls significantly below 1 hour. Device sent to mbnet Engineering GmbH for replacement of battery. Replaced on: The inspector 8 Troubleshooting 8.1 Possible Errors Error Possible Causes & Indications Error Localization & Troubleshooting Pump is not working (no audible noise) Loose connecting plug at pump No power Firmly push in connecting plug Pump is working, but there is no suction Loose hose connection at pump or leaking hose Hoses are kinked or pinched Check hose connection for tight fit Eliminate cause Weak suction Leaking hose connection at pump Check suction lines for tight fit Loose suction line in control box Pump is working, but there is no or little suction, electrodes are falling off during cardiac stress test Leaking suction line Suction cups not seated properly on electrode element Suction cup hose attachment twisted or rolled up Exchange suction line Firmly seat suction cup over electrode element Battery is totally depleted Battery is defective and/or doesn't work Dirty electrode elements or suction cups Electrode elements and suction cups Prolonged time of non-use Device minimum: 3.5 hours connected to power grid Battery life has been exceeded Contact customer service Should these tips be of no help in fixing the problem, please call your mbnet Engineering GmbH dealer or directly contact mbnet Engineering GmbH. Please have your model name and serial number ready. They are listed on the type label on the pump housing. Page 22
Operating Manual ergo vac LT 8.2 Eliminating Electromagnetic Interference The user can reduce electromagnetic interference by observing the recommended minimum distances between portable and mobile RF communications equipment (transmitters) and the device. The distance to be maintained depends on the output power of the respective telecommunications device, as shown in the following table. * "Non-ionizing electromagnetic radiation" RF Source Transmission Frequency (MHz) Power P (W) Radio telephone (Microcellular) CT1+, CT2,CT3 885-887 0.010 0.23 Distance d (m) Wireless DECT phone, Wi-Fi, UMTS cell phone 1880-2500 0.25 1.17 Mobile phone, cell phone, USA 850/1900 0.6 1.8 Mobile phone, cell phone - GSM900, - GSM850, NMT900, DCS 1800 900 850,900,1800 2 1 3.3 2.3 Walkie-Talkie (emergency services, police, fire department, maintenance crews) Cellular base stations (emergency services, police, fire department) 81-470 5 2.6 81-470 100 11.7 This table shows that mobile RF communication devices should generally not be used at a distance less than 3 meters from the device including the leads. Other steps the user can take to eliminate electromagnetic interference are: increasing the distance to the source of the interference. turning the device to change the angle of exposure to the radio waves. connecting an equipotential bonding cable. connecting the device to a different power outlet only using original parts. 8.3 Warranty mbnet Engineering GmbH accepts the statutory warranty in accordance with its sales, delivery and payment terms. All wear parts and consumables are excluded from the warranty. The warranty is forfeited: in case of damages resulting from improper and inappropriate use in case of improper installation, interventions by unauthorized persons or use of parts, consumables or spare parts not originally supplied by mbnet Engineering GmbH. Page 23
ergo vac LT Operating Manual 8.3 Warranty if changes, extensions, repairs and any other type of work was carried out on the device by a person not authorized by the manufacture if the electrical installation of the room, in which the device is connected, does not meet the VDE 0100-710 standards if the operating manual is ignored when using the device 8.4 Parts and Consumables Always use spare parts and consumables supplied by mbnet Engineering GmbH or products that are approved by mbnet Engineering GmbH. Failure to do so may pose a risk to life and / or void the warranty. All consumables and accessories for the device are available at your local distributor. A complete list of mbnet Engineering GmbH distributors can be found on the website of mbnet Engineering GmbH. If you have problems, please contact our head office directly. Our staff is always at your disposal to deal with your concerns and answer your questions. 9 Technical Data 9.1. Pump Module Dimensions Weight Power Supply Power Consumption Fuse 170 x 170 x 55 mm 1.2 kg 100-240 VAC 30 VA 2 x T1.6A/250V Battery (Option) Battery life Charging time to 100 % Charging time in use SLA (Sealed Lead Acid) Accu approx. 800 charging cycles approx. 3.5 hrs. approx. 10 hrs. Ambient conditions Operating temperature Relative humidity Air pressure during use 10 to 50 C, storage 10 to 40 C 25 to 95 % (non-condensing) 700 to 1060 hpa Vacuum Air flow 0-500 mbar 0-5.5 l/min Page 24
Operating Manual ergo vac LT 9.2 Patient Module Defibrillation protection 10 KOhm with surge protection 5 vacuum levels 80, 120, 160, 200, 220 mbar 9.3 System Cable System cable ECG connection Control cable Hose 1.9 m 15-channel in accordance with IEC Standard Norm 1.5 m 1.5 m 9.4 Electrodes Material Protection sintered Ag/AgCI, suction cup made of silicon Defibrillation-proof 9.5 Cable Arm Length Range of height adjustment 505 to 945 mm 835 mm Pivot range 300 9.6 Safety Standards Safety standard IEC/EN 60601-1 IEC/EN 60601-2-25 EMV IEC/EN 60601-1-2 Safety Class Class I in accordance with IEC/EN 60601-1 Compliance/Classification Protection CE/I in accordance with EC Directive 93/42/EEC This device is not intended for outdoor use (IP 20) Page 25
ergo vac LT Operating Manual Assurance of Compliance EC Assurance of Compliance Directive 93/42/EEC Appendix VII Directive 2007/47/EEC Appendix VII The manufacturer mbnet Engineering GmbH Kirschauer Strasse 37a D-02681 Callenberg hereby declares that the product ergo vac LT (Class I) is in compliance with the following: Directive 93/42/EEC Directive 2007/47/EEC Applied Standards IEC 60601-1 IEC 60601-1-2 IEC 60601-2-25 Manuel Bucher (Management) Callenberg, 30.10.2016 Page 26