Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Subscribe to Our Youtube Channel
Related Manuals for Globus AMI-LIFE
Summary of Contents for Globus AMI-LIFE
- Page 1 AMI-LIFE REV.3 ‐ 29 MARCH 2022 ...
- Page 2 AMI-LIFE DEAR CUSTOMER, THANK YOU FOR CHOOSING A GLOBUS PRODUCT. WE REMAIN AT YOUR DISPOSAL FOR ANY ASSISTANCE OR ADVICE YOU MAY NEED DOMINO s.r.l. via Vittorio Veneto 52 31013 - Codognè - TV - Italy Ph. (+39) 0438.7933 Fax.
-
Page 3: Table Of Contents
AMI-LIFE Table of contents TECHNICAL FEATURES ....................5 Device ........................5 Technical features of EMS currents: ................. 5 Disposal of the device ....................6 Declaration of conformity ..................6 INTENDED USE ......................7 The class risk of the device is IIa................... 7 EQUIPMENT ......................... 8 LABELLING AND SYMBOLS .................... 9 Device ........................11 Electrodes ......................11 Dashboard and keyboard ..................12 Display and interface ..................... - Page 4 AMI-LIFE Turn on ........................20 “Last 10” Menu ...................... 20 "Program List" menu ..................... 21 Start program ......................21 How to Increase and decrease intensity..............21 Display during execution ..................21 How to pause the program ..................21 How to stop the program ..................22 “Favorites” Menu ....................22 “Treatments” Menu ....................22 "Advanced" menu ....................22 PROGRAM LIST ......................25 Programs – Dysphagia ................... 25 ELECTRODE POSITION ....................
-
Page 5: Technical Features
AMI-LIFE TECHNICAL FEATURES Device Dimensions: 160x99x35.4 mm Weight: 404 g Case: ABS Protection level of the case: IP 20 + IP02 Use Conditions Temperature: From 0°C to 35°C Maximum relative humidity: 15% to 93% Atmospheric pressure: from 700 hPa to 1060 hPa Storage and transport conditions Temperature: From -10°C to 45°C... -
Page 6: Disposal Of The Device
AMI-LIFE Battery Battery Pack: Ni-MH 7.2 V 1.8 Ah Disposal of the device Do not throw the device or parts of it into the fire; dispose of the product in the specialized centers and respecting the regulations in force in your country. When the product has to be disposed of, the user can give it back to the retailer when purchasing a new device. -
Page 7: Intended Use
AMI-LIFE INTENDED USE The product has an estimated usable life of 5 years. It is advisable to return the device to the producer and/or the authorized center to perform security and maintenance checks every 2 years. The number of treatments depends on the battery charge. -
Page 8: Equipment
AMI-LIFE EQUIPMENT The electrostimulation device is supplied with all the necessary cables and electrodes; therefore, when you open the package, check that the basic equipment is complete. If some elements are missing, contact your authorized retailer immediately. -
Page 9: Labelling And Symbols
AMI-LIFE LABELLING AND SYMBOLS Warning The device can emit an output over 10mA or 10V This symbol indicates that the device complies with the directives on medical devices (93/42/EEC 47/2007/EEC). The number of the notified body is 0476. - Page 10 AMI-LIFE It indicates the pressure of the environment in which the device and the accessories are transported and stored. It indicates the humidity of the environment where the device and the accessories are used and stored. IP20 It indicates water protection.
-
Page 11: Device
AMI-LIFE Device Model: DK7-088-0200-EU PRI: 100-240V 50-60Hz 0.07A max SEC: 8.8V 200mA Nerve and Muscle stimulator: Ami lIFE Input power: 8.8V 200mA IP20 Battery power: 7.2V 1.4A Output: 20mA (1000Ω) *TYPEWWYYXXXXX* A4R301900949 Internal battery: 7.2V NiMH 1800mAh The first 4 digits of the serial number indicate the week and year of manufacture of the device you purchased (for example, if the code is *** 2319 *****, it means that the device was manufactured in week 23 of 2019). -
Page 12: Dashboard And Keyboard
AMI-LIFE Dashboard and keyboard Increase/decrease intensity buttons * button Function button P+ button Back/left button Right/User Button P- button ON/OFF/OK button NOTE: when the 3" message appears, it means that by holding the button down for 3 seconds the function is activated. -
Page 13: Display And Interface
AMI-LIFE Fn (Runtime) If pressed in combination with other buttons, it modifies their button function. If pressed alone during stimulation, it selects the Runtime mode (time, frequency and amplitude modification) Intensity button It increases/decreases the stimulation intensity of the corresponding channel. Display and interface Name of the program Work and rest time XXXXXXXX ... -
Page 14: Preparing The Device For Use
AMI-LIFE PREPARING THE DEVICE FOR USE To ensure maximum safety, the device must be used respecting the rules and the limitations indicated by the user manual. The manufacturer declines all responsibility with reference to a different use from what is indicated in this manual. -
Page 15: How To Connect The Cables
- It must be used with transcutaneous neurostimulation electrodes suitable for the use on the front of the neck. Only use electrodes supplied by Medical Kira Srl or Globus (Domino srl). - It must be kept out of the reach of children. - Page 16 AMI-LIFE 1. Do not apply on damaged skin 2. Clean the skin with a cleansing wipe 3. Let it dry for 30 seconds 4. Remove the electrodes from the package 5. Attach the specific cables to the electrodes 6. Remove the protective stickers placed on the side flaps 7.
-
Page 17: Battery
AMI-LIFE Before starting the treatment, always check the functionality of the electrodes Battery The device is supplied with a set of rechargeable nickel-metal hydrate batteries (7.2V, 1.8Ah) with high performance and without memory effect. The battery has an estimated usable life of 6 months without use. The number of re-uses (discharge and recharge) depends on the type of stimulation and the frequency with which the treatments are performed. -
Page 18: Safety Precautions
- If the cables are damaged, replace them with original spare parts and do not use them anymore. - Use only Medical Kira Srl or Globus (Domino srl) branded electrodes. - Current densities higher than 2mA/cmq (effective value) for each electrode must require special attention from the user. -
Page 19: Relative Contraindications
AMI-LIFE Contraindications Stimulation should not be applied: • if skin lesions or cancerous lesions are present in the treatment area • in cases where swallowing is prevented by other concomitant neurological disorders or by structural alterations of the apparatus •... -
Page 20: Instructions For The Use Of The Device
AMI-LIFE INSTRUCTIONS FOR THE USE OF THE DEVICE For a correct operation of the device, proceed as follows: - connect the cables to the sockets provided in the device; - connect the electrodes to the specific connectors at the ends of the cables;... -
Page 21: Program List" Menu
AMI-LIFE c - delete from list "Program List" menu By selecting "Program List", the following areas are displayed: - Dysphagia - Face Use the P+ and P- buttons of the joypad to select the desired area and press OK to confirm. -
Page 22: How To Stop The Program
AMI-LIFE How to stop the program To stop the program in advance, turn the device off by holding OK down for about 3 seconds. “Favorites” Menu The "Favorites" menu allows you to save your most used programs on a special memory, up to 15 for each user. -
Page 23: User Selection
AMI-LIFE Mode 2+2 User selection Work time Setup Turn off Mode 2+2 The device allows to execute 2 different programs at the same time, to treat two patients or two muscular groups simultaneously. How to set multiple treatments: There are two options to run two programs simultaneously: a) Select "2+2 mode"... - Page 24 AMI-LIFE In order to have access to the favorite programs and the "Last 10", the user just has to select his/her USER. The programs stored in this area can be used only by a specific user. NOTE : Every time the device is turned on, the latest user is displayed.
-
Page 25: Program List
AMI-LIFE PROGRAM LIST The following programs have been subject to certification. Because of the presence of clinical programs, this product is a medical device. Therefore it is certified by the Kiwa Cermet Italia S.p.A. Body n. 0476 according to the 93/42/EEC EU directive for medical devices. -
Page 26: Electrode Position
AMI-LIFE ELECTRODE POSITION The main cutaneous landmarks for the position of the electrodes: lower edge of the jaw, hyoid bone, thyroid and cricoid cartilage. The midline is very important. The figure shows the main landmarks drawn on the skin to know how to place the electrodes correctly. - Page 27 AMI-LIFE Variant of position A designed to optimize hypoglossal nerve recruitment. Figure 2: position A2 Fig.2 Position B Electrodes subhyoid, parallel and lateral to the midline (vertical). Figure 3: position B Fig.3 REV.3 ‐ 29 MARCH 2022 ...
- Page 28 AMI-LIFE Variant of position B designed to optimize recruitment in very short necks or in the presence of tracheotomies. Figure 4: position B2 Fig.4 Variant of position B2 designed to optimize and synchronize the recruitment of tongue and suprahyoid/subhyoid muscles Figure 5: position B3 Fig.5...
- Page 29 AMI-LIFE Position C The copy of the suprahyoid electrodes is horizontal while the subhyoid one is vertical and median. Figure 6: position C Fig.6 Variant of position C, the suprahyoid electrode is divided. Figure 7: position C2 Fig.7 REV.3 ‐ 29 MARCH 2022 ...
- Page 30 AMI-LIFE Variant of position C2, also called "cross". Figure 8: position C3 Fig.8 Position D The copy of the suprahyoid electrodes is vertical and median while the subhyoid one is horizontal across the thyroid cartilage. Figure 9: position D Fig.9...
- Page 31 AMI-LIFE Position E The two pairs of electrodes are located vertically on the midline of the neck, one suprahyoid and the other subhyoid. Figure 10: position E Fig.10 Position F The two pairs of electrodes are both in a suprahyoid position and parallel to the lower edge of the mandible, position known as the "anterior digastric".
-
Page 32: Maintenance And Cleaning
AMI-LIFE MAINTENANCE AND CLEANING Device - In case of actual or alleged malfunctioning, do not tamper with the device and do not try to repair it by yourself. - Do neither intervene on the device nor open it. Only specialized and authorized centers can repair it. -
Page 33: Warranty
AMI-LIFE Make sure that the electrodes do not touch each other and do not overlie one over the other. Once the package has been opened, the electrodes can be used for 25-30 applications. The electrodes must always be replaced if they do not stay perfectly in contact with the skin. - Page 34 NOTE: Before returning the device for repairs, we recommend reading carefully the user instructions in the manual and visiting the Globus website. If you have to return the product for repair, please contact your dealer or the Globus customer service.
-
Page 35: Emc Accompanying Documents
AMI-LIFE EMC accompanying documents Essential performance PERFORMANCE CONDITION RISK ACCEPTED EVENT Electrostimulation. External Display information The machine must stop the disturbance no longer readable. stimulation. (Burst). The machine must maintain the stimulation and accept the commands. Lack of internal... - Page 36 AMI-LIFE load the default settings present in copy in the memory and indicate on the display that the reset has been carried out. Unreadable display. The machine must check the value of the contrast setting. If it is out of range, the machine must reset the value to the default one.
- Page 37 AMI-LIFE REV.3 ‐ 29 MARCH 2022 ...
- Page 38 AMI-LIFE REV.3 ‐ 29 MARCH 2022 ...
- Page 39 AMI-LIFE REV.3 ‐ 29 MARCH 2022 ...
- Page 40 AMI-LIFE REV.3 ‐ 29 MARCH 2022 ...
Need help?
Do you have a question about the AMI-LIFE and is the answer not in the manual?
Questions and answers