NAHE e CUT operator’s manual PN 409110-006 Revision A marquetie | CcéE Medical SystemsNOTE Due to continuing product innovation, specications in this manual are subject to change without notice. © Copyright Marquette Medical Systems, Inc. 1998, Allrights reserved. ‘Trademorked names appear throughout this document. Rather than list the names and entities that own the, aa crits or moert a trademark symbol with each mention ofthe trademarked name, the publisher states that | itisusing the names only for editorial purposes and to the benefit ofthe trademark owner with no intention of improperly using the trademark. ‘ACCUSKETCH, AccuVision, APEX, AQUA-KNOT, ARCHIVIST, Autoseq, BABY MAC, CardioSery, CardioSmart, sec eay CardioWindow, CASE, CD TELEMETRY, CENTRA, CHART GUARD, CINE 35, CORO, COROMETRIES GHG PLUS, Digitore, Digital DATAQ, E for M, EAGLE, Event-Link, HELLIGE, IMAGE STORE, LASER SXP, MAC. GNC TAR MACTRODE, MARQUETTE, MARQUETTE MAC, MARQUETTE UNITY NETWORK, MARS, MAX, MADITEL, MEL, MEI in the elrcle logo, MEMOPORT, MEMOPORT C, MINISTORE, MINNOWS, Monarch 6000, MULTELINK, MULTISCRIPTOR, MUSE, MUSE CV, Neo-Trak, NEUROSCRIPT, OnlineABG, OXYMONITOR. see cutt PRESSURE. SCRIBE, QMI, QS, Quantitative Medicine, Quantitative Sentinel, Qwik Connect Spal RAMS RSVP, SAM, SEER, SOLAR, SOLARVIEW, Spectra 400, Spectra-Tel, ST GUARD, TRAM, TRAM-NET, He ALRAC TRAMSCOPE, TRIM KNOB, UNITY logo, UNITY NETWORK, Vari-X, Vart-X Cardiomatio, VaniCally VAS, Vision Care Filter, are trademarks of Marquette Medical Systems, Inc, registered in the Unieed States Patent and Trademark Office 12S1, 15SL, AccuSpeak, ADVANTAGE, BAM, BODYTRODE, Cardiomatic, CardioSpeak, CD TELEMETRY®-LAN, sae ee COPE, Corolation, Corometrics Sensor Tip, DASH, EDIC, HI-RES, IMAGE VAULT, IMPACT af SNTELLIMOTION, INTER-LEAD, IQA, LIFEWATCH, MARQUETTE MEDICAL SYSTEMS, MARQUE’ RESPONDER, MENTOR, MicroSmart, MMS, MRT, MUSE CardioWindow, OpSENSOR, OMS, Premiums RAG, UI VERTRACE, SMART-PAC, SMARTLOOK, Spectra-Overview, Tximline, UNITY, Universal, are trademarks of ‘Marquette Medical Systems, Inct CE Marking Information Complianoe Exceptions General Information Mh ees 20 Tradl uC ck CB E89 is conformity withthe provisions ofthe Council Directive 98/42/EEC concerning ‘medial devices and us the essential requirements of Annex 1 of this thst, Te product in u-nerferncepoeton cas Ain. acetic with EN 55011, For devices manufactured in the United States, the CE:mark is applied under the authority of Notified Body GMED (0459). For devices manufactured in Germany, the CE mark is applied under the authority of Notified Body VDE (0366). ‘The country of manufacture and appropriate Notified Body can be found on the ‘equipment labeling, ‘The product withthe requirements of standard EN 60601-1-2 “Electromagnetic Compatibility - Medica! Electrical Equipmen:” ‘The CE marking prescribed above is only found on the equipment labeling of the 230V European equipment. Only applicable equipment will bear the CE, marking. “The safety and effectiveness ofthis device has been verified agsinst previously distributed devices, Although all standards applicable to presently marketed ‘devices may not be appropriate for prior deviees (.c. electromagnetic ‘compatibility standards), this device will not impair the safe and effective use of those previously distributed devices, Sec user's information. ‘he Secie 2600 fread EMC Iman nally Peorssance ‘Users should be aware of known RF sources, such as radio or TV stations and hhand-held or mobile two-way radios, and consider them when installing a ‘medical device or system, ‘Be aware that adding accessories or components, or modifying the medical ‘device or system may degrade the EMI performance. Consult with qualified ‘personnel regarding changes tothe sytem configuration.Mate Malt, Maru aig Gin 200 Wea Tver Avene Mano Stu 3, D791) Fe P.O, Hor 8181 — = vad, Wish) : USA ‘ ‘Tok #1 44385000 Tel 49761 45430 Pax +1 4143853790 Panis 7614548 391.” EC Declaration of Conformity Dossier No. CE-C-030 Product details: 1. Name: Series 2000 Treadmill T2000-}00C XXX 2. Product Part number: 3. Classification: Class Ila per Annex IX, Rule10 of the Council Directive 93/42/EEC 4, Intended use: ‘The Series 2000 Treadmill consists of a motor drive system, elevation system, bed assembly and an letonic assembly. Standard features include a sop switch fall handel set, and a 60-inch long walking surface, ‘The device is intended to be used in conjunction with any one ofthe several Marquette Medical Systems ECG stress testing systems forthe purpose of administering a controlled exercise load during a diagnostic stress ex ‘The device is intended for use under the direct supervision of aHoensed health care practitioner. Assessment details: 5. Notified Body: G-MED France Number: 0459 6.Conformity Route: Corometics Maca Systems, nc asa G-MED EC Cerificate of approval oft ull Quality Asura Syton va ‘Annex I point 3 Directive $3/42/EEC conceming medical devices. Device categories include patent montoring ‘oftware and paint dat management. The Quality Sytem has teen ISO 9001 snd EN 46001 cerca, 7.EC Certificate Number(s): 0063/82P4/2; 00638001/2; 006314600172 8, Certification date(s): July 8, 1996 - foreach ites ‘We declare that the device described above is in compliance with the following directives, standards and normative documents: 1. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 2, EN 60601-1:1990, A1:1993 / IEC 601-1:1988, A1:1991 3. EN 60601-1-2:1993 /TEC 601-1.2:1993, ‘The technical documentation is maintained in the CE Regulatory File of: ‘Corometrics Medical Systems, Inc. 61 Bares Park Road North ‘Wallingford, CT 06492 USAIntroduction | Manual Information Revision History Manual Purpose Gonvention onan Safety information Responsibility of the Gena Equipment Symbols ‘Warnings and Cautions Service Information .. Service Regu Equipment Identification.Introduction, Marl rfermatin Manual Information \ SS Revision History Revision Date Comment Fach page of the document has the document part number andreviion letter atthe bottom ofthe page, The eislonlter denies the document's update level, ‘The revision history ofthis document is summarized in the table below. [8 | ray 1998 Initial release of manual Manual Purpose ‘This manual contains the instructions necessary to operate the equipment safely in accordance with its function and intended use, ‘These instructions include but are not limited to: m= an explanation of the function of controls and indicators, = the sequence of operation, = connection and disconnection of detachable parts and accessories, and = instructions for operator cleaning, preventive inspection and maintenance. ‘Where necessary the manual identifies additional sources of relevant information and/or technical assistance,Introduction: Mal Information Conventions ‘Those are the conventions wsedn this manual Satety Messages , DANGER safety messages indicate an imminently hazardous situation hf not avoided, WILL result in death or serious ino ARON afte idx potently hava sation ch fot avoided, COVLDresutin death reiusu CAUTION safety messages indicate a potentially hazardous situation ‘which, ifnot avoided may result in minor ot moderate injury. [NOTE messages provide additional user information. Definitions ' Items shown in Black text are keys on the text tobe centered, or hardware items such as buttons or switches on the equipment. stems shown in Italicized text are software terms which identify ‘ment items, buttons, or options in various windows. ‘To perform an operation which appears with a plus (sign pbenveen the names of two keys, you press and hold the first Key Wihle pressing the second key once. This is called a keystroke combination. For example, “Press CtrlBse” means to press and hold down the Ctrl key while pressing the Esc key. When instructions are given for typing a precise text string with ae br more spaces, the point where the spacebar must be pressed is indicated as: , The purpose of the <> preekets is to ensure you press the spacebar when required. Enter means to press the “Enter” or “Return” key on the Keyboard. Do not type “enter” LAARAAAAAAAMAANAAAA A AAR ARARABAvuuUuU -— tet ay ratn Safety Information Ss Responsibility of the Manufacture General uur isp ctl a h rly, and peformane oly i : 4 Assembly operations, extensons,readjustments,molications, ortepairs are carried Out by persons authorized by Marquet, The electrical installation ofthe relevant room complies with the requirements ofthe appropriate regulations. = The equipment is used in accordance with the instructions for use, ‘This device is intended for use under the direct supervision of alicensed health care practitioner. To ensure patient safety, use only parts and accessories manufactured or recommended by Marquette Medical Systems, Contact Marquette Medical Systems for information before connecting any devices to this equipment that are not recommended in this ‘manual. If the installation of this equipment, in the USA, will use 240 V rather than 120V, the source must be a center-tapped, 240 V, single-phase circuit. Parts and accessories used must meet the requirements of the applicable IEC 601 series safety standards, and/or the system configuration must meet the requirements of the IEC 601-1-1 medical electrical systems standard. ‘The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to.a reduced level of safety of the resulting system. Consideration relating to the choice shall include: use of the accessory in the PATIENT VICINITY; and '™ evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 601-1 and/or IEC 601-1-1 harmonized national standard,| Introduction: Safety Information Equipment Symbols —*etolowingymbosappearon the equipment A ot 0 > This symbo means that yo ust pay tern oth dca led wht tquipment, calls attention to the things to which you must pay spc attention - portion and whn the equipment i operated in conjunction wth ther qupment, In Euop, hs symbol mean dangerous righ vue. Inte Und Sats, hs Symbo represents te eauton notice below A CAUTION SEs To reduce the risk of electric shock, do NOT remove cover (or back). Refer servicing to qualified personnel. ‘Type B equipment. Typa B equipment is suitable fr intentional extemal and internal ‘application to the patient, excluding direct conductive connection to the patient's hear. ‘Aternating current (AC) @ Equipotential (This is the ground lug.) Protective earth (ground)a Introduction: Safety Infomation Warnings and Cautions ray Koop hands, har, Jowelry, and loose clothing away from moving parts. AWARNING Ey | Replace only with the ALWARNING ‘same type and rating Rn Sica! treadmill during saws elevation changes. Otherwise, serious injury could resuit. AWARNING — ee This is Class | eauipment. The mane _AWaARNING plug must be connected! © [g to an appropriate power er os er. cable avay trom sere moving parts. “AWARNING Se Do NOT contact unit or A\WARNING patient duri e Setiritation” nay ieee. assembly, pn 8380-006, aa every month. naa > AWARNING AWARNING Wait until treadmill belt Operate the treadmill > a cal ato aIntroduction: Service Information Service Information ener ence Service Requirements fr eupmen sero Marquet Medal Syms author service personne! only, Any unauthorized attempt to repair equipment under warranty volds that warranty, [tis the wser' responsiblity to report the need for service to Marquette Modal Systems oto one of their authorized agents, Failure on the part of the responsible individual, hospital, or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. ‘Regular maintenance, irrespective of usage, is essential to ensure that the Series 2000 treadmill will always be functional when required ‘Technical specifications describing the equipment can be found in the “Series 20000 treadmill field service manual,” PN 409110-004. Equipment Identification Every Marquette Medical Systems device has a unique serial number for identification. The serial number appears on the product label on the base of each unit 1 A} —e aes ' sean re ee tem Name Description ‘A | name of device ‘Series 2000 treadmill, a 8 | mmanitacturet Marquette Medical Systems, Ine G | serial number Unique identifier D> | device characteristics One or two letters that further describe the unit for example: P = prototype not conforming to marketing specification; R= refurbished equipment: S = special [product documented under Specials part numbers; U = upgraded unit E | division FeCardiology @=Monitoring J = Cath Lab F | product sequence umber | Maniffactuting number (of total units manufactured) G | product code ‘Two-character product descriptor YS = Series 2000 treadmill 4 ‘year manifactired 721997, 8- 1998, 94999, {and so on) E iLEquipment Overvigw Inde USE on... Preparation for Use Safe Handling Guidelines Equipment Assembly Handle Set. Emergency Stop Switch... Connector Locations Operating instructions Electrical Safety Tests Operating Controls Power Switch Emergency Stop Switch Controlling the Treadmill... Emergency Stop Switch Check ...Introduction: Service Information Service Information Service Requirements ed equipment servicing to Marquette Medical Systems’ authorized se Equipment Identification personnel only, Any unauthorized attempt to repair equipment under warranty voids that warranty. {tothe wer’ respons to report the wee for service to Marquete edo ims or one of tel uae agen, Fallon he prtof th respon dividual, opt ot buon ‘using this equipment to implement a satisfactory maintenance heats ‘may cause undue equipment failure and possible health Regular maintenance, irrespective of usage, is essential to ensure that ‘the Series 2000 treadmill will always be functional when required Technical specifications describing the equipment can be found in the “Series 20000 treadmill eld service manual," PN 4091 10-004 Every Marquette Medical Systems device has a unique serial number for identification. The serial number appears on the product label on the base of each unit. [SS soon eee es ET roe STE He . nT cae WSxNos1 5 / %) worsens 721997, 8="1998, 9 1999, (and so on) tem Name Description ‘A | name of device ‘Series 2000 treadmill 4 B | manitactirer ‘Marquette Medical Systems, Ine C | serial number Unique identifier | device characteristics ‘One or two letters that further desoribe the unit, for example: conforming to marketing specification; R = refurbished equipment; S = special product documented under Specials part numbers; U = upgraded unit E | division F=Cardiology —G=Monitoring J = Gath Lab F | product sequence number "| Manifactuting nimber (of total units manufactiréd) 6 | product code ‘Two-character product descriptor YS = Series 2000 treadmill Hh | year manaitactured I month manufactured Ae MarcEquipment Overview: interided Use - Intended Use ‘The Series 2000 Trend is intended for ue with any one ofthe several | Marquette Medical ystems ever tenting systems othe MTC) | (manual treadmil contol fr administering controled exercise | Joad during a diagnostic stress test, Standard features include the | eee and along, 60-inch walking surface, ‘The emergency stop switch is intended for emergency situations where immediately stopping the treadmill is required to deliver appropriate ‘emergency care to the patient or health care provider, as implied by the ‘American Heart Association “Guidelines for Clinical Exercise Testing Laboratories” (1995). Its not intended for routinely stopping theEquipment Overview: Preparation for Use Preparation for Use : i ‘ EL | i ‘The Series 2000 Treadmill ships preset ieee 2% grade. Safe Handling ‘This sight elevation provides for free wheel movement and prevents the € Guidelines shroud rom scraping the foot. Ifyou are moving the treadmill after it has been in operation, use the controlling equipment to set the grade to approximately 7%. Then remove power and disconnect all cables to the treadmill before moving the unit Follow the steps below to move the treadmill. We recommend thattwo © people work together since the treadmill may be too heavy for some individuals to lift and lower safely. € 1. Lifteendof te bed assembly abouts heighs keeping Jnees bent and backs straight as you lift, 2. Rotate the treadmill in the direction you want to go (the ‘treadmill will pivot on its wheels) and push forward. 3, When you have maneuvered the treadmill into its new location, gently lower the end of the bed assembly to the floor. stinnnnnnnnnaneannnEquipment Overview: Preparation for Use Equipment bly The Series 2000 Treadmill ships completely assembled except for the 4 quipment Assembly handle set and the emergency stop switch. Attach the handle set and emergency stop switch before applying power to the unit [ENO a ‘AG recommended by the Amalia Hoat | Assocation Exercise Standards (Special Report, Vol 82, No 6), the treadmill should have front and side rails installed for patients to steady themselves. An emergency stop Switch must be visible and readily | aocessioa, rr! Handle Set 1. Insert the wood front handrail into the metal side rails, then align the predriled holes and screw in the two Phillips screws on both sides. Assemble the optional side rails in the same way. Pace the assembled front handrail ino the metal mounting, brackets on the front comers of the shroud, Usi the su Allen wrench and four bolts, secure the ieee the eee |. Place the assembled side rails into the side mounting holes and Sctew in the two bolts on each side. SS Wood Front Handrail > Screw Ss 2 Wood Side Handrail oa rato ar eae sittings i ownage | i a aioe Right Side. 25Equipment Overview: Preparation for Use 4. Attach the side rails to the front rail with the mated T-brackets ‘Tighten the two T-bracket bolts with the Allen wrench. ‘Align the side ralis to the pi diiled guide holes in the front ral, } © | 4 Emergency Stop ‘Switch 1. Attach the two clamp pieces to the assembled, latching, Lager Emergency Stop rea 2 BR Ts tae ie : Comme i 7 ‘wont? 2. Position thé clamps around the treadmill front handrail and secure with the supplied screw and nut. 3. Connect the cable from the emergency stop switch to the mating connector on the treadmill’s rear connector panel.“ 4, Use the cord clips to attach the cable along the front han ean ON TrradtilMaintenance and Technical Specifications: Technical Spe: Technical Specifications DIAC Spectication ‘Manirivm Rated Load 482 kg (460 ls) | Drive Motor 3.0HP, brushless, DC motor Elevation Motor O18 HP Belt Speed Range 0.0 to 22.6 km/h (00 13.5 mph) at 220V, @ 50/60 Hz continuously variable, zero mph start-up Belt Speed Tolerance +#0.16km/h (20.1mph) Belt Speed Acceletion’ecelartion | Approximately 0.8 kes (05 mphisee) Elevation Range 0.00 25.0% grade, continuously variable Elevation Range Increase/Decrease | 1.14%h/sec, @ 60 Hz P| Manuel Treamil Conover (Optional) ncn. OF, Up, Down, Fast, Sow, Automatic Procol Selection, Elapsed Time, Distance Traveled ‘Automatic Protocols: 15 exercise and 15 rehabiitation (Includes Bruce, Naughton, Bake I, Ellesad, Low Performance) ‘Maximum Leakege Current 100 A, chassis to ground ) — S antettace Either RS-292 port or RS-422 serial port, 9600 baud Mode of Operation Continuous Degree of protection against ingress!”’| ‘Ordinary of water se] Le tom Specification Weigit © | 1814 kg (doo iby Walking Area 45.7 cm x 152.4 om (18 in x60 in) Floor Space Required ‘TBI coh x195.6 om (29 in X77 in) Walking Surface Height 14.0 om (5.5 in) | Handrail Height Above Walking Front! 101.6 cm (40 in) [ surface Side: Maximum 88.9 cm (35 in) doscencing at 5° angle to 81.3 cm (32 in) ES Fanon Stes Rane | tem Specification Power Reguirements 200 to 265 VAC, 60 Hz, single phase, 20/A, NEMA 6-20 R wall socket (dedicated circuit recommended) | Power Consumption | 1540 wats, 16.4 Revision A ‘Series 2000 Treadmit 35 400110-008