Product Manual
Contents
1. as L XA I USO DS 1 A Connect the USB cable to the USB charger supplied in the box cable and the USB charger Alternatively you can plug the electronic device to your PC d Ny using the USB cable ek WU A green light will turn on It will turn off when the battery is fully recharged Unplug the electronic device from the t shirt and plug it to the power supply using the USB 1 A USB cable and USB charger In use a green blinking light indicates that remains only 5 of the battery about 30 minutes 1 B Place the SD card in your PC s card reader 1 B SD card configuration Open VJ Desktop Reader and select the option Configure SD Card in the Tools Menu A message asking to confirm the format is displayed Click Yes to confirm to finalize the configuration 13 bio FAQs of La A La I What it is Vitallacket is a medical monitoring device that allows the user to perform a ECG with all confort while wearing a t shirt with a small electronic device in the pocket Who should use it Everyone is suitable for Vitaljacket as it is a non invasive device with no contra indications Vitaljacket is recommended for everyone needing to monitorize vital signals namely people with illness cardiac problems and Professional amateurs atheletes VitalJacket can under medical prescription replace the standard systems for ambulatory ECG How long can it be used VitalJacket can be continuo2. Remove the electronic device before wash the t shirt T shirt Wash Machine wash at 30 C FABRICADO EM PORTUGAL MADE IN PORTUGAL FABRIQUE EN PORTUGAL 80 POLIAMIDA POLYAMIDE POLYAMIDE 20 ELASTANO ELASTHANE ELASTANE E XA SH CONT M COMPONENTES MET LICOS ESPEC FICOS AO FUNCIONAMENTO DA PECA CONTAINS SPECIAL METALLIC COMPONENTS FOR FUNCTION OF THE GARMENT CE MOD LE CONTIENT DES COMPOSANTS M TALLIQUES N C SSAIRES SON FONCTIONNEMENT Do not bleach Iron at low temperature Do not clean dry H w Di K Do not tumble dry bio Equipment JA Ads ae x T shirt Electrodes SD Card Electronic Device Charger 10 Dio Dressthetshire lo 1 A Clean with alcohol and dry very well the zones of the body where the electrodes will be 0 an placed l In version VitalJacket 5L Motion the placement of the electrodes must follow the image e e e e coum BE VitalJacket 5L Motion VitalJacket 1L placed inside the t shirt image A 1 A Correct placement of the electrodes In version VitalJacket 1L the placement of the electrodes should follow the orientation of the image B or image C at 1 B Fixing the springs 1 B Dress the t shirt Fix the springs inside the t shirt to the electrodes placed in your body You should hear a click 1 C Check that the electronic device has a SD card and afterw
3. Bluetooth Caution consult safety manual Ponto verde Recycable package Waste Electrical and Electronical Device Manufacturer Fragile Keep dry Keep away from heat CE Mark Medical Device Handling Scope The VitalJacket t shirt is an ECG signal and heart rate monitoring system The VitalJacket is a medical device and as such it can be used for therapeutic or diagnosis purposes of La La lL The handling should comply with the instructions described in this user s manual Disclaimer of responsibility Warranty Biodevices S A guarantees that the VitalJacket electronic device is free from material or manufacture defects for a period of 2 years from the date of the purchase except for the battery 6 months and disposable electrodes For that purpose the owner should make proof of purchase Exclusions The warranty does not cover damages caused by repairs done by people or agents not authorized by Biodevices S A The warranty does not cover damages caused by bad handling accidents or incorrect maintenance of the VitalJacket t shirt The warranty does not cover cracked broken boxes or that present signs of visible impacts Do not open this electronic device Such violation will render the warranty null and void Handling Safety Precautions Read the user s instructions provided before using the VitalJacket t shirt The bluetooth symbol in relief in the electronic device should be directed t
4. Email info biodevices pt 23 Dio
5. Radio equipment and telecommunications terminal equipment R amp TEE DIRECTIVE 2002 95 CE Restricting the use of certain dangerous substances in electrical and electronic equipment RoHS DIRECTIVE 2002 96 CE Waste of electrical and electronic equipment WEEE Harmonized Standards ETSIEN 300 328 V1 7 1 Electromagnetic compatibility and radio spectrum ERM Systems for broadband transmission Data transmission equipment operating in the frequency of 2 4 GHZISM band that use modulation techniques in broadband EN 301 489 part 18 17 V1 4 1 Electromagnetic compatibility EMC standard for radio equipment and services Part 17 Specific conditions for broadband transmission systems at 2 421 bio a L XA I lL Conformity with the requirements of the United States of America and Brazil Requirements Applicable FCC Certification and Anatel radio This device complies with FCC and Anatel rules Any transaction with the same is subject to two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation 22 Support and Customer Support Als Repairs and servicing shall be performed by an Authorized Service Center of Biodevices S A Biodevices Sistemas de Engenharia Biom dica S A Avenida D Afonso Henriques 1462 1 Traseiras 4450 013 Matosinhos Portugal Contacts Tel 351 220 902 540
6. in use ZN Note The electronic devices are all identified by a MAC address with the following format 00 23 FE xx xx xx 16 Biodevices Edic o O Revis o 7 Medical Devices ISO 13485 PRO D U CT MAN UAL uality management Data 28 09 2009 Data 11 07 2013 ar eee Precautions Restrictidns and Wardings Guideline and Manufacturer s Declaration Electromagnetic Emissions The Vitalacket t is intended for use in an electromagnetic environment as specified below The consumer or user of VitalJacket must ensure it is used in this environment Conformity Electromagnetic environment guidance RF emissions Group 2 CISPR 11 RF emissions Class B CISPR11 Harmonics emissions Class B IEC 61000 3 2 bio Voltage fluctuations emissions N A IEC 61000 3 3 The Vital acket sends electromagnetic energy in order to perform the planned function Nearby electronic equipment may be affected The Vitallacket is suitable for use in all establishments other than domestic and those directly connected to public low voltage network which supplies buildings for domestic use provided that the following notice misunderstood Warning This equipment is intended for use only by healthcare professionals This equipment may cause radio interference or disrupt equipment operations nearby It may be necessary to adopt procedures for mitigation such as reorienting or relocating the VitalJacket or shielding of the
7. place Note It is very important that the true effectiveness of the RF shielding and the RF filter real attenuation of the shielded place are checked to ensure they meet or exceed the specified minimum values 17 a L XA I ws lL Guideline and Manufacturer s Declaration Electromagnefic Immunity The VitalJacket is intended for use in an electromagnetic environment as specified below The consumer or user of VitalJacket must ensure it is used in this environment Immunity tests IEC 60601 test level Conformity level Guidelines Electromagnetic environment The soil must be wood concrete or ceramic tiles If soils ESD 6 kV contact 6 kV contact are covered with synthetic material the relative IEC 61000 4 2 8 kV air 8 kV air humidity should be at least 30 The quality of the power source must be like the typical Burst 2 kV power line commercial or hospital environment ESOS 1 kV inputs outputs The quality of the power source must be like the typical Surge 1 kV differencial mode N A commercial or hospital environment IEC 61000 4 5 lt 5 UT The quality of the power source must be like the typical gt 95 UT drop to 0 5 of the of commerce or hospital environment If VitalJacket cycle requires continued operation during interruptions of the power source it is recommended that the Voltage drops short Sn MITE 40 UT Vitallacket is powered by an uninterruptible power and voltage fluctuation fli
8. Product Manual Vital acket WEARABLE ECG www vitaljacket com www biodevices pt Biodevices S A E DE REFER NCIA Av D Afonso Henriques 1462 1 Traseiras C 1 01 1 N 2 O NOVO NORTE SVE O Gm REGIONAL DO NORTE 7 2013 4450 013 Matosinhos Portugal UNI O EUROPEIA Vitallacket copyright La La I This Manual cannot be copied in whole or in part otherwise reproduced or translated into another language without the prior authorization of Biodevices S A The manufacturer reserves the right to alter all information contained in this manual without prior notice bio Edic o O Revis o 7 Data 28 09 2009 Data 11 07 2013 bio Index Product Information Safety Precautions Environmental Information Requirements for Cleaning and Disinfection Equipment Dress the t shirt Color code of the electronic device Prepare the next exam FAQ s Troubleshooting and Corrective Measures Specifications Precautions Restrictions and Warnings Coding Set Element and Accessories Manufacturer s Declaration 10 ill 12 13 14 15 16 17 20 21 Product Information JA gt Ads T shirt The VitalJacket 1L has 3 springs and the VitalJacket 5L Motion has 6 springs where the signal acquisition electrodes should be connected The t shirt also has a plug inside of a pocket where the electronic device should be connected Electronic Device The electroni
9. applicable in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Note 2 Itis essential that effectiveness and efficiency of the shielding and attenuation filter of the shielded location is checked to ensure they reach the minimum specification The field strengths of fixed emitters such as broadcast stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio and TV broadcast can not be theoretically predicted with accuracy To assess the electromagnetic environment due to fixed RF transmitters should be considered an electromagnetic local inspection If the field strength far from the place where the shield is used VitaJacket exceed 3 V m the VitalJacket should be monitored to verify normal operation If anormal performance is observed additional measures may be needed such as replacing the VitalJacket site or use a shield with an efficiency of RF shielding and attenuation filter higher 19 bio e Coding Set Element ane 1 T shirt ccessorie ssories Als PCB Charger SD Card Products Manual CD with software Dectardl Manufacturer s Declar ioa o Lado Conformity with the European requirements Applicable Directives DIRECTIVE 2006 95 CE Electrical equipment for use within certain voltage limits LV DIRECTIVE2004 108 CE Electromagnetic compatibility EMC DIRECTIVE 1999 5 CE
10. ards connect it to the plug inside de y the pocketofyourt shirt A red light should start blinking When the red light is blinking normal 1 time per second the device is acquiring the signal and AS write data on SD card If the red light don t blink remove the SD card from the electronic device and put it back again If the red light is blinking fast 3 times per second the SD card is full and don t record the data 11 1 D Electronic device in operation bio Color code of the electronic device a tn device DR a 4 Redlight Working Blinking normal 1 time per second device is acquiring signal and writing data in SD card Blinking fast 3 times per second device is acquiring signal but is not recording data the SD card is full Don t blink remove the SD card from the electronic device and put it back again Green light Battery Blinking slow 1 time per 5 seconds battery under 30 Blinking normal 1 time per second battery under 15 Blinking fast 3 times per second battery under 5 Light on battery charging when the light turns off the battery is fully charged Blue light Bluetooth Blinking normal 1 time per second Bluetooth is active but is not connected to any electronic device Blinking 5 times and from then blinks slowly 1 time per 8 seconds Bluetooth is on and the electronic device is empaired with another device PC PDA etc bio 12 Prepare the next exam I ae y 2
11. c device allows acquiring the Electrocardiogram ECG signal and the heart rate All data acquired will be stored in a SD Card provided as accessory Furthermore this device has Bluetooth communication for sending receiving data The electronic device has 3 lights that indicate the state Red light heart rate Green light device charging Blue light Bluetooth connected bio lt 2 A APP 7 vital acket Vital 3 Ick Wearable r of La La lL To charge the battery of the electronic device it should be connected to the battery Battery charging and charger charger provided The green light power supply should switch on While this light is on the device is charging Accessories A SD Card is provided to be used with the electronic device The VJ Desktop Reader must be used to configure the SD Card A set of 25 electrodes is also provided for the first usages The electrodes can be bought from Biodevices S A or at a specialized store We call your attention to the fact that the system was tested with electrodes provided by Biodevices S A Biodevices S A does not take any responsibility for any bad results deriving from the use of other electrodes N Note There are electrodes on the market with different features and applications You should choose the most suitable electrodes bio Safety Precautions of LA LA 7 lL Symbols Symbol Description 4H Bb P C 1011
12. cker 60 UT drop to 5 cycles N A source or a battery 70 UT 30 UT drop to 25 cycles Interference immunity against 5 no o lt 370 UT The magnetic fields in the power frequency should be at magnetic fields with power frequency gt 95 UT drop to 5 s AN nos characteristic levels of a typical commercial or hospital 50 Hz 60 Hz t environment IEC 61000 4 8 18 of La La I Guideline and Manufacturer s Declaration Electromagnetic Immunity The VitalJacket is intended for use in an electromagnetic environment as specified below The consumer or user of VitalJacket must ensure it is used i this environment Immunity tests IEC 60601 test level Conformity level Guidelines Electromagnetic environment Interference immunity 3 Vrms to power line based The VitalJacket should only be used in a shielded location with a intereference 150 kHZ to 80 MHz N A minimum efficiency RF shielding and for each cable entering the IEC 61000 4 6 shielded location a minimum attenuation of the RF filter efficiency shield specification of the attenuation filter Field strengths outside the shielded place from fixed RF transmitters determined by an electromagnetic site inspection should be less Interference immunity 3 V m than 3 V m against radiated 3 V m interference 80 MHz to 2 5 GHz Interference may occur in the vicinity of equipment marked with this IEC 61000 4 3 symbol Note 1 These guidelines may not be
13. o the outside of the t shirt Battery charging must be done with the electronic device outside the t shirt Handle the electronic device with care avoid dropping and strong impacts The electronic device is not waterproof and may be irretrievably damaged if water is allowed inside bio Environmental Infor PROA A y ja Packing The packing is made of 100 recyclable material and it contains the respective symbol For its disposal itis mandatory to comply with a certain number of rules on packing legislation The packing material plastic bags etc should be kept out of the children s reach given thatit is potentially dangerous Electronic Device This electronic device complies with the European Directives 2002 96 EC Waste Electrical and Electronic Equipment WEEE and 2002 95 EC Restriction of Hazardous Substances RoHS The symbol contained in the product or accompanying documentation indicates that rather than handle this product as household waste it should be delivered at specialized centres that collect and recycle electrical and electronic equipment Disposal of this product must be carried out in accordance to the regulations of your local authority For information on handling recovery and recycling this product contact the respective centre in your local area the household waste pick up service or the shop where this product was purchased bio Requirements for Cleahing and Disi Requirem Cio fe tion ja
14. usly used as long as needed with no contra indications Where to buy Vitaljacket can be directly bought to Biodevices S A or to any local partner see Partners in www biodevices pt How many ECG leads There are two versions of the product the VitalJacket 1L with 1 lead and the VitalJacket 5L Motion with five leads both have the function of screening and comfortable monitoring of ECG for long periods of time The VitalJacket 1L uses three electrodes to record an ECG lead D1 The VitalJacket 5L Motion uses six electrodes to record three limb leads D1 D2 and D3 and two precordial leads How to wash Remove the electronic device box from the t shirt s pocket and follow the labeled instructions 14 bio Troubleshooting and Chrrective Mek sures Edic o O Revis o 7 Specifications of La I ole Product Description Transport and storage specifications The VitalJacket is a Class lla medical device that allows to do an continuously and noninvasively electrocardiogram ECG The product consists of a t shirt and an electronic device Electronic Device Operating Conditions Dimensions 66x38x16mm Weight including battery pack 509 Communications Specifications Bluetooth 2 0 Class 2 Power 2 5 mW Frequency 2 4 Ghz Range 10 m direct line ZN Note The index of protection against electric shock is not applicable because the electronic device is never a charge when
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