P8000 3/12-Channel ECG Unit - Frank's Hospital Workshop

1 P8000 User : 9740440041 Rev.: aP80003/12- channel ECG UnitP8000 User : 9740440041 Rev.: aP80003/12- channel ECG UnitDistributed by:ESAOTE : +39 055 4229 1 Via Di Caciolle 15 Fax: +39 055 4229 20850127 Firenze, by:SCHILLER AGPhone: +41 (0) 41 766 42 42 Altgasse 68 Fax: +41 (0) 41 761 08 80,CH-6341 Baar, SwitzerlandE-mail: and Service InformationThe ESAOTE sales and service centre network is world-wide. For the address ofyour local distributor, contact your nearest ESAOTE subsidiary. In case of difficul-ty a complete list of all distributors and subsidiaries is provided on our internet site: : 9740440041 Rev.

2 : aIssue date: : by:ESAOTE : +39 055 4229 1 Via Di Caciolle 15 Fax: +39 055 4229 20850127 Firenze, by:SCHILLER AGPhone: +41 (0) 41 766 42 42 Altgasse 68 Fax: +41 (0) 41 761 08 80,CH-6341 Baar, SwitzerlandE-mail: and Service InformationThe ESAOTE sales and service centre network is world-wide. For the address ofyour local distributor, contact your nearest ESAOTE subsidiary. In case of difficul-ty a complete list of all distributors and subsidiaries is provided on our internet site: : 9740440041 Rev.: aIssue date: : Page 1 User Guide : 9740440041 Rev.

3 : aContents1 Safety notes .. of the User .. Use .. Measures .. Operation .. Facilities .. with other Devices .. Symbols and Pictograms .. of Warranty .. 72 Introduction .. Features .. Philosophy Functions or Tasks .. Components of the Panel .. Screen .. 133 Operation .. and Initial Preparation .. Operation .. ON and OFF .. the Mains Supply .. Printing Paper .. contrast Patient Data .. 174 Resting ECG .. Placement .. Lead Positions for Additional and Neutral Electrodes Identification and Colour Code.

4 Electrode Resistance Indication .. and Patient cable Check (Lead Test).. of Operation and Procedural Mode .. 25 Page 2 : 9740440041 Rev.: Mode .. (and Manual Printout) (option).. the Recordings .. 305 Setup .. the SETUP Menu .. in the Setup Format 1 and 2 Internal Printer .. Format 1 and 2 External .. (Only with version C) .. (only with version m = Memory) .. and Information .. Print Setup .. Communications Test .. Installing New Software Options (Upgrade).

5 Update the Software .. Default 446 Care & Maintenance .. (RS-232) Monthly Check .. interval for the battery .. the battery .. disposal .. the fuse and mains voltage .. the the Patient Cable .. the Thermal Print the Recording Paper .. Paper Handling .. and Disposables .. 517 Technical Data .. Data for Standards .. 548 Index ..55 Page 3 Safety notes1 User GuideResponsibility of the : 9740440041 Rev.: a1 Safety Responsibility of the User Intended Use Organisational MeasuresVThis device must only be used by qualified doctors or trained medical numerical and graphical results and any interpretation given must be exami-ned with respect to the overall clinical condition of the patient and the general re-corded data indications given by this equipment are not a substitute for regular checkingof vital the competencies of the personnel for operation and that personnel have read and understood

6 These operating instructions. Inparticular this chapter safety notes" must be read and damaged or missing components replaced operator is responsible for compliance with all applicable accident preventionregulations and safety P8000 is a 3/12-Channel , ECG device used for the recording, analysis andevaluation of ECG Recordings. Recordings made with the P8000 can be used asa diagnostic aid for heart function and heart conditions. The P8000 is designedfor indoor use and can be used for all patients of both sexes, all races, and is no danger for patients with Only operate the device in accordance with the specified technical system is not designed for sterile use nor is it designed for outdoor not use this unit in areas where there is any danger of explosion or in the pre-sence of flammable gases such as anaesthetic unit is CF classified and defibrillation protected only when the originalpatient cable is used.

7 However, as a safety precaution when possible, removeelectrodes before product is not designed for internal product is not designed for di-rect cardiac using the unit , ensure that an introduction regarding the unit functions andthe safety precautions has been provided by a medical product these operating instructions in an accessible place for reference when re-quired. Make sure that they are always complete and the operating instructions and maintenance operating instructions do not override any statutory or local regulations, orprocedures for the prevention of accidents and environmental OperationPage 4 : 9740440041 Rev.

8 : Safety-conscious Safety FacilitiesVMake sure that the staff has read and understood the operating instructions - par-ticularly the "Safety Notes" not touch the unit casing during must be ensured that neither the patient nor the electrodes (including the neu-tral electrode) come into contact with other conducting objects (even if these areearthed).VImmediately report any changes that impair safety (including operating beha-viour) to the person not place any liquids on the unit . If liquid should be spilled over the device,immediately disconnect the device from the mains and wipe it.

9 The device mustbe serviced before the device without the correctly rated fuse, or with defective cables,constitutes a danger to life. Therefore: Do not operate the unit if the earth connection is suspect or if the mains lead isdamaged or suspected of being damaged. Damaged cable connections and connectors must be replaced immediately. The electrical safety devices, such as fuses, must not be altered. Ruptured fuses must only be replaced with the same type and rating as the ori-ginal. Page 5 Safety notes1 User GuideOperation with other : 9740440041 Rev.

10 : with other only accessories and other parts recommended or supplied by of other than recommended or supplied parts may result in injury, inaccurateinformation and/or damage to the equipment connected to the analogue and/or digital interfaces must becertified according to the respective IEC standards ( IEC/EN 60950 for dataprocessing equipment and IEC/EN 60601-1 for medical equipment). Furthermoreall configurations shall comply with the valid version of the system standard IEC/EN 60601-1-1. Everybody who connects additional equipment to the signal inputpart or signal output part configures a medical system, and is therefore responsi-ble that the system complies with the requirements of the valid version of the sy-stem standard IEC/EN 60601-1-1.