Summary of Contents for Mortara Instrument ELI 100
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REF: 9502-057-50 A1 ELI 100 Operator’s Manual ________________________________________________________________ CAUTION: Federal law restricts this device for sale to and use by or on the order of a physician.
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This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. ELI 100 is a trademark of Mortara Instrument, Inc.
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Bologna, Italy Toll-free Service Number: 888-MORTARA Phone: 39-051-6645-360 Fax: 414-354-4760 Fax: 39-051-6651-012 E-mail address: sales@mortara.com Mortara Instrument, Inc., GMBH (Germany) 24 hour technical support Henricistr. 124 Over 120 trained field service technicians 45136 Essen Same day shipment of replacement parts...
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Failure to do so may cause undue failure and possible health hazards. Equipment Identification Mortara Instrument equipment is identified by serial numbers on the back or bottom of the device. Care should be taken so that these numbers are not defaced.
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Warranty Information Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Products”) shall be free from defects in material and workmanship under normal use, service and maintenance for the warranty period of such Product from Mortara or an authorized distributor or representative of Mortara.
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UL2601-1, IEC 601-1 or IEC 601-2-25, consideration should be given to the requirements of IEC 601-1-1. • The ELI 100 has not been designed for use with high-frequency (HF) surgical equipment and does not provide a protective means against hazards to the patient.
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ELI 100. The external modem and its power supply must comply with the requirements of IEC 60950, safety of information technology equipment, including electrical business equipment.
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• After operating the ELI 100 using battery power, always reconnect the power cord and depress the I on the I/O power switch. This ensures that the batteries will be recharged for the next time you use the ELI 100. The...
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Equipment Symbols Symbol Delineation Attention, consult accompanying documents Alternating current Protective earth (ground) Earth (ground) Fuse Telephone line (modem) Defibrillator-proof type CF input Thermal paper Equipotentiality Output/Transmit...
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Input ON (power) OFF (power) "ON" only for part of Equipment "OFF" only for part of Equipment Stop (of action) Shift key (to enter upper case text) Space key Enter key (accept data/return) ⌫ Backspace/Delete key Initiate printing of 12-Lead ECG viii...
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Initiate printing of continuous rhythm strip High-speed serial data Eject Indicates compliance to applicable EEC directives...
System Description ............................1-1 ELI 100, Illustration ............................1-2 ELI 100 Specifications ............................ 1-3 Setup and Installation ............................. 1-4 ELI 100, Two Views: Left Side and Rear ......................1-4 Rear (Fuse Installation)........................... 1-5 Configuration Settings............................. 1-5 Initial Configuration ............................1-7 Protected Configuration ..........................
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Protected Configuration Screen O........................1-17 Site Name ................................1-17 Protected Configuration Screen P ........................1-17 Key Click Volume Setting ..........................1-18 Persistent Configuration ..........................1-19 Load Thermal Paper............................1-20 Apply Power..............................1-20 ELI 100 Supply List............................1-21 Operation Starting the System ............................2-1 Operation .................................2-1 AC Power Operation............................2-1 Battery Operation.............................2-1 Patient Preparation............................2-2 Patient Hookup ..............................2-2...
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Self-Test Printout Sample, Pg. 1 of 2......................6-3 Self-Test Printout Sample, Pg. 2 of 2......................6-4 Cleaning and Inspection ..........................6-5 Inspecting the ELI 100 ............................ 6-5 Cleaning the ELI 100 ............................6-5 Cleaning the Patient Cable ..........................6-5 Cleaning the Writer Printhead......................... 6-5...
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Glossary ............................. G-1 Index ................................ I-1 Figures Figure 1-1 ELI 100 ............................1-2 Figure 2-1 ELI 100 Left and Rear ........................1-4 Figure 3-1 ELI 100 Rear (Fuse Installation) ....................1-5 xiii...
Text that appears on the screen, such as C:\Portrait, appears in normal, Arial font. System Description The ELI 100 is a diagnostic electrocardiograph capable of acquiring and printing ECG data in a hospital and/or clinical environment. If the ELI 100 is equipped with the computerized interpretation option installed and is enabled, which is at the user’s discretion, the acquired electrocardiogram may assist in allowing the physician to...
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ELI 100_____________________________________________________________________________ The ELI 100 consists of: • Electrocardiograph • ELI 100 Operator’s Manual and short form instruction card • Accessory Kit Figure 1-1, ELI 100, Illustration...
____________________________________________________________________________Section 1 ELI 100 Specifications Leads available: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 ECG input: Simultaneous input from all 12 leads Input impedance: Meets the requirements of ANSI/AAMI EC11 Input dynamic range: Meets the requirements of ANSI/AAMI EC11...
Power will appear on the LCD screen. If fuse is removed, stored data and configuration settings will be lost. 100The battery fuse is installed in the back of the unit, as pictured above. The fuse is installed so the ELI 100 can store data, operate on the internal battery, and save the configuration settings.
____________________________________________________________________________Section 1 NOTE: If you remove the battery fuse after the ELI 100 is in operation, any ECGs stored in the unit will be lost and the initial and protected configuration settings will change to their default settings. The persistent site and cart number configuration settings will be preserved.
Details to access the protected and persistent configuration menus follow. The custom ID format, which is designed in the E-SCRIBE system, can be downloaded to the ELI 100. When you select (0) DWNLD ID, the following screen appears: NOTE: The site number must be configured in the cardiograph and recognized as an established, valid site number at the E-Scribe before downloading the custom ID.
Protected Configuration The protected configuration menu allows the user to define the ELI 100 operational conditions that do not change on a daily or patient-to-patient basis. Once you set these default conditions, you will rarely need to use the protected configuration program again.
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Storage Format There are two available storage format options in the ELI 100. One format stores 2.5 seconds of each of the twelve leads. The other storage format option, which is the default setting, stores the full 10 seconds of all twelve leads.
Main Menu Plot Format The ELI 100 automatically analyzes ECGs and prints the interpretation on the ECG printout. The Plot Format option allows you to select or suppress the “interpretive” text on the ECG report. NOTE: A qualified physician should review the computer generated ECG interpretation before the treatment of any patient.
ELI 100_____________________________________________________________________________ Protected Configuration Screen D Plot Plot Freq: 150Hz Channels: Exit to Main Menu The ECG plot frequency default setting is 150Hz, or select 40Hz. The recommended setting is 150Hz. Plot Channels This option defines the default for the available plot channels. The plot options are: Format Option ECG Data 2.5-second graph of 12 leads in...
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____________________________________________________________________________Section 1 The patient's name, ID number, race, age, height, weight, gender and medications are printed across the top left section of the printout. Measurements are printed in the middle to include ventricular rate, P-QRS-T axes, PR interval, QRS duration and QT/QTc. On the top right of the printout, the ECG interpretation and reason statements are printed.
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ELI 100_____________________________________________________________________________ STD Format at 50 mm/sec 1-12...
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____________________________________________________________________________Section 1 STD Format with Long ID 1-13...
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ELI 100_____________________________________________________________________________ STD Format with Short ID 1-14...
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____________________________________________________________________________Section 1 4CH Format Option The 4CH (short) format is a 4" by 11" strip containing a condensed graph of the 12 leads in a 4-channel format. Three channels contain a labeled median complex for each of the 12 leads, and the fourth channel contains a 10- second rhythm strip of lead II.
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ELI 100_____________________________________________________________________________ The date and time of acquisition, location, writer speed for the median complexes and rhythm strip, plot frequency and software version are printed across the bottom of the printout. The median complexes are arranged in columns or leads I, II, III; aVR, aVL, aVF; V1, V2, V3; and V4, V5, V6. Ten seconds of lead II are printed below the median complexes.
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____________________________________________________________________________Section 1 2PG Format Option The 2PG (two-page) format is a 4" by 22" strip containing one page in the STD format (refer above) followed by one page containing 3 channels of rhythm leads II, V1, and V5. The following print is an example of the 2PG format: The patient ID information, measurements, ECG interpretation, acquisition time, location, writer speed and software version number are printed on the rhythm strip in the same format as the STD format.
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ELI 100_____________________________________________________________________________ MSR Format Option The MSR format option is available when selecting a copy (CPY) of an ECG from the ECG Print Option screen or ECG Maintenance screen, Section 5. This option is not available when selecting a plot channel format in Configuration screen D.
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____________________________________________________________________________Section 1 R wave amplitude [µV] R wave duration [ms] S wave amplitude [µV] S wave duration [ms] R' wave amplitude [µV] R' wave duration [ms] S' wave amplitude [µV] S' wave duration [ms] ST segment displacement at J point [µV] ST segment displacement at the mid-point between STJ and STE [µV] ST segment displacement at the end (defined as 1/8 the...
The baud rate determines the serial port’s data transmission rate in bits per second (bps). The baud rate is set to 38400 bps for direct data transmission between the ELI 100 and another unit; and for a direct connection to the E- SCRIBE system;...
____________________________________________________________________________Section 1 Auto Delete This option defines the ECG auto delete status in the directory. Deleted ECGs will be removed as the directory becomes full. The selections are: OFF = ECG is never automatically deleted from the directory. PLT = ECG is automatically deleted from the directory after plotting. XMT = ECG is automatically deleted from the directory after transmission.
ELI 100_____________________________________________________________________________ Pre-append site number to patient ID When yes is selected for this configuration setting, the site ID, followed by a dash, will be displayed when the user enters the patient ID. The user will not be able to erase the site ID and dash before entering the patient ID. The patient ID with the site ID pre-appended shall become the true patient ID and be displayed that way whenever the patient ID is displayed and printed.
This option defines whether or not the ELI 100 is to save all newly acquired ECGs in the directory. If the selected configuration option is set to OFF, the ELI 100 asks if you wish to save each new ECG after it prints. A “YES”...
Cart#: Site Number Read only Display. This option identifies the site of your ELI 100. Site numbers designate the hospital, clinic, or institution for ECG records stored in a Mortara Instrument, Inc., E-SCRIBE system and must be defined for transmitting. You can use up to four digits for the site number; numbers from 0 to 9999 are supported. See Persistent Configuration for details to edit site number.
The LONG format is identical to the STD format except that it includes the patient's first name, room and comment fields. The CUSTOM format, which is designed in the E-SCRIBE system, can be downloaded to the ELI 100. When you select the CUSTOM format and press the ENTER key, the following screen appears.
ELI 100_____________________________________________________________________________ Rhythm Lead Selection This option defines the programmable rhythm strip selections for 3-channel rhythm strips. Using the 4, 5, and 6 soft keys, you can toggle through each of the 12 leads to select the entries for the three channels. The factory-set default values are: Channel 1: Lead II Channel 2: V1...
____________________________________________________________________________Section 1 Key Click Volume Setting This option defines the data entry click loudness. Press the soft key (2) to toggle through and select soft, medium or loud. EXTERNAL MODEM The external modem initialization string is accessed by selecting ALT + SPF from the main menu and then ALT + I.
ELI 100_____________________________________________________________________________ %T19, 0, XX Country Australia Czech Republic 25 Hong Kong Hungary India Indonesia Japan Korea New Zealand Philippines Poland Singapore South Africa Slovenia Persistent Configuration The persistent configuration menu allows the user to define the site number and the cart number. Begin from the Initial Configuration menu (ALT+SPF from the main screen).
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____________________________________________________________________________Section 1 After the new numbers are entered, the user will have the option of saving them to FLASH memory. Saving new #’s will erase directory. Save new #’s?: If you choose to save the newly programmed site and cart numbers, the following message appears: Program FLASH with new Site/Cart #’s? 1-29...
ELI 100_____________________________________________________________________________ Load Thermal Paper Paper Installation Procedure To open the writer, push the writer bar to the right. This releases a latch, which makes an audible click. Once released, pull up and back on the bar to open the writer cover. To install paper: Insert a four-inch roll of thermal paper into the writer trough, as pictorially represented on the inside of the writer.
To apply power to the electrocardiograph unit: Plug the power cord into an AC wall outlet and into the back of the ELI 100. Flip up the I/0 power switch, to the I position (flat to the side of the unit). The I /0 power switch can and should remain in the I position at all times.
P/N 9502-057-50 ELI 100 Operator’s Manual • P/N 9503-038-01 ELI 100 Short Form Instruction Card To order additional supplies, contact a Mortara Instrument customer service representative at: Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, WI 53224 Phone: 888-MORTARA (414) 354-1600...
If the batteries are not charged adequately, the message BATTERY LOW appears on the LCD screen. If the battery fuse is not installed correctly or is not functioning, a blank screen is displayed on the ELI 100. See Section 6, “Troubleshooting.”...
NOTE: If no keys are pressed for about four minutes, the ELI 100 turns itself off to conserve battery power. The only exception to this operation is when the user prints a continuous rhythm strip or if the AC power is on.
New Patient? STAT NOTE: If the patient is connected to the electrocardiograph and you press the ECG or RHY key, the ELI 100 automatically begins the 10-second ECG acquisition while you are entering the patient's identification data. Therefore, you should instruct the patient to relax in a recumbent position to ensure that the ECG is free from noise and artifact due to patient activity.
ELI 100_____________________________________________________________________________ ID Menu Prompts Depending on the ID format configured at setup, a series of LCD prompts tells you what patient information to enter. After you type in the requested data and press the ENTER key, the blinking cursor moves sequentially to the next data entry field.
____________________________________________________________________________Section 2 ID Menu Sequence, Long Format Screen Prompts Data Entry Instructions Last name: Type the patient's last name (up to 20 characters). Press ENTER. First name: Type the patient's first name (up to 10 characters). Press ENTER. Patient ID: Type the patient's identification number (up to 12 digits) using the numeric keys.
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ELI 100_____________________________________________________________________________ ID Menu Sequence, Long Format, Continued Medication 1: Press the forward or backward arrows (soft keys 8 and 9) to scroll the list of 10 groups for a selection: Blank (no entry) Digitalis Beta Blocker Quinidine/Norpace Diuretic Calcium Antagonist Proc/Lido/Tocainide Other Antiarrhythmic Psychotropic...
ID information, which you can add to an ECG. You should begin routine ECGs by connecting the patient to the ELI 100 and entering the patient identification information as described in Section 2. After you complete the last data entry field on the ID...
ELI 100_______________________________________________________________________ ECG Analysis The ELI 100 analyzes the ECG in approximately three seconds. The LCD screen briefly displays the following status condition: ANALYZING ECG The writer then prints an 8 1/2" by 11" strip that graphs the 12-lead ECG data in the format selected at setup.
______________________________________________________________________Section 3 Format Option ECG Data 2.5-second graph of 12 leads in a 3-channel format (Standard) Condensed graph of 12 leads in a 4-channel format (3 channels contain a labeled median complex; 4th channel is a 10-second rhythm strip of Lead II) Standard format PLUS a 3-channel 10-second strip of each Leads V1, II, V5 (Two Page)
ELI 100_______________________________________________________________________ Selecting an E-SCRIBE Patient File The Request Selection screen (on the next page) appears when you select the REQ function. The top line of the LCD displays the name and ID of each patient on file • To scroll through the list of patients, use the << (6) (previous) and >> (7) (next) keys or access the patient data with the keyboard by entering the first letter of the last name.
Acquiring Routine Rhythm Strips You should begin routine rhythm strips by connecting the patient to the ELI 100 and entering the patient identification information as described in Section 2. After you complete the last data entry field on the ID menu and press the ENTER key, the rhythm strip begins printing.
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ELI 100_____________________________________________________________________________ The GRP key (0) selects a new lead group. The available groups are: LEAD GROUP DESCRIPTION I, II, III 3-channel format aVR, aVL, aVF 3-channel format V1, V2, V3 3-channel format V4, V5, V6 3-channel format Frontal 6-channel format: I, II, III, aVR, aVL, AVF Precordial 6-channel format: V1, V2, V3, V4, V5, V6 The Writer Speed key (2) changes paper speed options (25 mm/s, 50 mm/s, 5 mm/s, 10 mm/s).
An ECG may be listed in the directory but have a “deleted” status. The directory keeps deleted ECGs in the event that you may want to recover an ECG at some later time. However, the ELI 100 will write over a deleted ECG if the directory is full.
ECG, or it may cause a reset of the electrocardiograph configuration and directory. If a reset occurs, the ELI 100 displays an error message indicating that you must reconfigure the setup parameters. If this occurs, contact your Mortara Service Representative for assistance.
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EX key: Returns you to the Patient ID screen. The first patient name to appear on the Patient Selection screen depends on the most recent action that took place in the ELI 100. You will see a patient name for one of the following: •...
Press the YES key (4) to erase all the selected patient's ECGs or press the NO key (6) to return to the Patient Selection screen. NOTE: Erasing ECGs permanently removes the records from the ELI 100. There is no way to recover an erased ECG.
____________________________________________________________________________Section 5 Listing a Patient's ECGs To list all the ECGs for a specific patient, select the patient's name and press the LIST key. The writer produces a printout similar to the illustration below. Patient Directory Name Patient ID Date Time PLT XMT RTV 19:33:02...
ELI 100_____________________________________________________________________________ Erasing a Specific ECG To erase a specific ECG record for the selected patient's name, use the << or >> keys to select the ECG that you want to erase. The LCD screen displays a message asking you to confirm your instruction to erase the ECG. ERASE ECG –...
• Connect the ELI 100 to a standard telephone jack with the provided phone line cable. Plug the cable into the telephone jack located on the left side of the ELI 100 and the other end into a telephone wall jack. However, if you are using an external modem, connect the provided phone line cable to the back of the modem and connect to a standard telephone jack.
ELI 100_____________________________________________________________________________ Sending ECGs To batch transmit all ECGs from the ELI 100 directory, select the Main Menu and press the XMT function key on the right side of the keyboard. NOTE: You cannot batch transmit deleted ECGs. Once you have used the batch mode of transmission, you cannot batch transmit the same ECGs again. However, you can transmit the ECGs individually from the Directory Maintenance screen.
____________________________________________________________________________Section 5 Batch Plotting You can batch plot (print) ELI 100 unplotted ECGs. Press the BATCH PLT key on the Special Function screen. The unit automatically prints all the directory’s received or retrieved unplotted ECGs. Downloading a Request List The ELI 100 can download and process a patient request list that identifies the ECGs needed from the E-SCRIBE system.
• Edit or update patient identification information by pressing the ID key. The LCD screen displays the ID menu. See Section 2 for instructions on how to enter patient ID information. NOTE: You cannot directly enter requests on the ELI 100. To do so, you must first download requests from an E-SCRIBE.
____________________________________________________________________________Section 6 6 Maintenance and Troubleshooting Troubleshooting Chart LCD Message Problem Correction BATTERY LOW Unable to acquire Charge the battery with AC ECG. power. BATTERY LOW Unable to print. Charge the battery with AC CANNOT USE PRINTER power. (No message; screen is Blank screen.
(RAM). If there is an error in the memory's write or read process, the address location of the error is displayed in brackets [ ] on the screen. If this occurs, contact your Mortara Service Representative. To exit the Self-Test mode, turn the ELI 100 OFF and then back ON.
All cords and connectors are securely seated in their corresponding connections. • The thermal writer paper is installed grid side up. CAUTION: Do not attempt to clean the ELI 100 or patient cable(s) by submerging into a liquid, autoclaving, or steam cleaning. Cleaning the ELI 100: Disconnect the power source.
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ELI 100_____________________________________________________________________________...
In addition to having records of this information, the system information provides a warranty record of when your system was placed in service. System Information Log Manufacturer: Product Information: Mortara Instrument, Inc. Name of Unit/Product: ELI 100 7865 N. 86th St. Milwaukee, WI 53224 Date of Purchase: ___/___/_____ Telephone Numbers: Purchased Unit From: ____________________...
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ELI 100_____________________________________________________________________________ For questions or service information when calling in, have the serial number and the reference number available. The Serial Number and Part Number (REF) are found in the following places: Product Information Serial Number and Ref. Number (REF) Figure A-a Serial Number –...
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_____________________________________________________________________________Glossary Glossary TERM DEFINITION Arrhythmia Irregularity in the rhythm. Augmented lead (aVL, aVR, aVF) The difference between one site and the average of the potential of two other sites; unipolar extremity leads. Baseline drift The QRS complexes are present, but the baseline wanders due to poor skin/electrode contact and/or patient movement.
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ELI 100_____________________________________________________________________________ ST segment Ventricular repolarization. The end of the S wave (J point) to the beginning of the T wave. Tachycardia A rapid heart rate.
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ECG Selection Screen Description 3-1 ELI 100 Specifications 1-3 Parameters, Operational 1-6 ELI 100 Supply List 1-21 Patient Files, E-SCRIBE 3-4 100ELI 100, Illustration 1-2 Patient Hookup 2-2 ELI 100, Two Views: Left Side and Rear 1-4 Patient ID Screen Description 5-5...
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Protected Configuration Screen B 1-9 Storage Format1-8 Protected Configuration Screen C 1-9 Storage Sensitivity1-9 Protected Configuration Screen D 1-10 Supplies, ELI 100 1-18 Protected Configuration Screen E 1-11 System Description 1-1 Protected Configuration Screen F 1-11 System Information Log A-1...
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INSTALL ENCLOSED FUSE ATTENTION! BEFORE OPERATING UNIT. BEIGEFÜGTE SICHERUNG VOR ACHTUNG! INBETRIEBNAHME INSTALLIEREN. ATTENZIONE! INSTALLARE IL FUSIBILE FORNITOPRIMA DI ACCENDERE L’APPARECCHIO. COLOCAR EL FUSIBLE ANTES ATENCION! DE ENCENDER EL APARATO. INSTALLER LE FUSIBLE CI- ATTENTION! JOINT AVANT D’UTILSER L’APPAREIL. OBS! MONTERA MEDFÕLJANDE SÃKRING FÕRE UPPSTART.
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