User Manual 2015
Contents
1. light whenever it recog nizes the R peak A blue LED indicates that the heart rate is over 40 but below 120 beats per minute In case the heart rate is not within the set limits this is indicated with red LED Do not use the device in conjunction with a defibrillator or within the vicinity of MRI equipment Too much body hair may disrupt electrode operation Do not use any wireless communication devices in proximity of the device A strong electric or magnetic field may cause false heart beat indication May cause mild skin irritation to those with a sensitive skin Modification of the device is strictly forbidden Patient movements may cause false heart beat indication Fast or irregular heart beats may cause temporary red heart beat indication turning into blue Blue heart beat indication may take several seconds e Tall T wave may cause erroneous heart beat indication Warning Using the Device Picture 1 Open the package by tearing Picture 2 Remove the sticker s protective film from the base of the device Picture 3 Adhere the device to the patient with the Sticker The recommended installation location is the patient s left side of the chest between the pectoral muscle and the costal arch at a 20 degree angle Picture 3b Alternative installa tion location Picture 4 Move the detachable LED unit to a place in clear view such as the patient s face the edge of the stretcher or above the2. patient s clothing Leave some slack in the unit s cable and ensure that the cable does not rub against a zipper for instance Picture 5 Remove activation sheet After removal the blue LED of the LED unit should remain lit for 5 seconds In a model DHBI 2 the numeric display shows Check whether the LED unit s light indication functions correctly 10 seconds after activation a red or a blue light should blink on every heart beat If after activation the device does not detect the patient s heart beat check the heart beat by removing the device and installing it again at the left side of the chest between the collarbone and the pectoral muscle as in picture 3b In these cases patient s heart beat should be checked with alternative means The device may be faulty if the lights do not turn on or they turn on in the other order Discard the faulty device and use one that functions correctly Warning When you are installing the device avoid pressing directly on the top of the elec trodes When the hydrogel in the electrode pad is pressed it can suffuse the sticker area and re move the sticker from the skin The product will adhere well when you press the sticker from the side of the electrodes Note The device may temporarily be re Note The device turns off automatically moved and re adhered to allow patient after it has been detached for more than treatment 10 minutes Product can be reattached within two hou
3. the in dication light completely while the heart rate display will stay in the dim mode The display and its normal brightness will return if you press it again End of Use After removing the device from the pa tient the red LEDs remain lit for 10 minutes and then switch off automatically After use normally dispose of the product as electrical and electronic waste Devices contaminated by blood or other secretions have to be disposed of as biologically contaminated electrical or electronic hazardous waste a Symbols Individually packaged The device is for single use only Protected against spraying water For waste disposal the device is classified as an electronic device according to WEEE directive 2002 96 E4 BF Type applied part Technical Specifications Key Features e Disposable e Activates when the activation sheet is removed e Adjustable LED brightness e Visualizes the patient s heart beat with a light e Long usage time Technology Single use ECG based heart rate measurement Measurement range of 20 300 BPM Heat rate Measurement accuracy 2 BPM Three ECG electrodes AgCI on the electrode membrane Integrated heart rate measuring electronics LED unit s cable length 45 cm Packaged hermetically Battery powered
4. 24 Spektikor disposable ECG indicator USER MANUAL DHBI 1 and DHBI 2 Rev 30 2303201 Manufacturer Spektikor Oy Elektroniikkatie 3 90560 Oulu Finland www spektikor com CE 0598 The product is classified as a medical device in compliance with directives 2002 96 EC WEEE 93 42 EEC and 2002 95 EC ROHS Usage Time and Temperature DHBI 1 over 20 hours 35 50 C 31 122 F DHBI 2 over 6 hours 35 50 C 31 122 F Storage weight less than 10 kg Long term storage 4 years between 0 35 C 32 95 F Short term storage 2 weeks between 25 65 C 13 149 F Min a Max 40 C 435 C 32 F 4 95 F Long term storage ts EALA Not for children Min a Max 25C 65 C 13 F 4 149 F Short term storage i Read instructions before use Read instructions before use Patents and patents pending FI 20106249 EP11190444 7 and 13 303 744 USA NATO CAGE Code A653G NATO Stock Numbers 6515 58 000 6107 7434 7435 7436 7437 and 7438 Spektikor DHBI 1 and DHBI 2 are trademarks of Spektikor Oy Spektikor is the tool for professionals to easily monitor and detect changes to a patient s heart rate Spektikor is ad hered to the patient like regular ECG electrode with the adhesive located in the base of the device The LED unit can be detached and moved to a spot in good view The device indicates the ECG curve by flashing the
5. rs Heart Beat Indication Upon activation of the device first the blue LED remains lit for 5 seconds followed by continuously lit red LEDs When after installation the heart beat is detected a blue LED or two red LEDs DHBI 1 or one red LED DHBI 2 blink on every heart beat In case no heart beat is detected the red LEDs remain continuously lit In case the batteries are running low or when the device detects a technical failure the blue and red LEDs blink simultaneously with one second intervals DHBI 1 The device is ready for use DHBI 2 contains the three digit numeric heart rate display a blue LED and a red one During operation the display shows the current heart rate value beats per minute bpm If the device does not detect a heart rate this is indicated by three lines If the battery alarm is activated the screen lights up the code E DHBI 2 Use in low dark light DHBI 1 DHBI 1 2013 includes a button that can help you regulate the brightness level of the heart rate indication The first press will dim the indication light Normal brightness will return if you press it again DHBI 2 DHBI 2 includes a button that can help you regulate the brightness level of the heart rate indication The indication light and screen will dim if you use the dim mer button The first press will dim the indication light and the heart rate dis play The second press will dim
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