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CARESCAPE™ V100 Vital Signs Monitor

1. ode Source Definition on i Probable Source or Problem Silenced Display System Failsafe error No Mains PWA issue blank high pitch alarm 891 System Hostcomm command forced safe state No Check comms cable connections 892 System Hostcomm buffer full No Check comms cable connections 920 NIBP Comm timeout between main No Mains PWA issue processor and nibp subprocessor 921 NIBP Startup communication failure with No Mains PWA issue NIBP processor 922 NIBP NIBP processor reports communication No Mains PWA issue timeout 923 NIBP Determination time too long No Mains PWA issue 930 SpO gt No status from module for 60 10 sec No Verify SpO gt configuration is Fatal error reported by module correct type Parameter turned on no hardware installed in unit 940 Temp TEMP data samples less than 45 in 5 No Mains PWA issue sec while idle 950 NIBP NIBP pump on during idle or over No Pneumatic assembly failure current detected 951 NIBP NIBP valve stuck closed during cuff No Pneumatic assembly failure typing 952 NIBP NIBP PT2 higher than 150 for greater No Pneumatic assembly failure than 15 seconds while idle 970 Printer Time base failure No Mains PWA issue 971 System RAM test failure No Mains PWA issue 972 System ROM checksum failure No Mains PWA issue 973 System Secondary 12C communication error No Mains PWA issue during initialization 974 System Calibration data invalid on initialization No Calibrate unit or u
2. 3 6 Configuring Your V100 Monitor L cece cece eee eee eens 3 7 Operating Modes x desi eden DANI LESE ENG Nes 3 7 Clinica Md train iux alar 3 7 Gonfiguration Mode ii en di 3 7 Advanced Configuration Mode LL 3 11 A e RET ERRARE ET 3 12 Host Communications Connector oooooooccocccccconoooom 3 15 DB15 Connector Pin Assignments 6 0000 cece eee eens 3 15 Connection Details 2 0 e ence eae 3 15 Maintenance 4 1 Preventative Maintenance cee eee cece eee eee ne 4 3 erum e 4 3 Integrity of Hoses and Cuffs eerus tirer ccc cece eee ees 4 3 Visual Inspection u e i xl e e i ERL eee 4 3 Cleaning seceded Ate IRAE adidas idad 4 4 Cleaning the Monitor i oi thee eer du e edd 4 4 CMT IS NE tom seen uu MEA ERI SEM NE a ae rn en Ane 4 5 Temperature DEVICES oes so enter RARI 4 6 SPOZISENSOTS cus E NS 4 6 Long Term Storage cee ee cece eee eee eect eee e en 4 6 Battery Cares iia as tac ire saddens 4 7 Replacing the Battery Laikas 4 8 2037106 001B CARESCAPE V100 Vital Signs Monitor iii Parameter Level Functional Testing o oooooooooooo 4 9 NIBPZ cori a etu el ure qt NM Nt t 4 9 Ternperdtule a e Be 4 9 Ohmeda Nellcor and Masimo SpO2 Technologies 4 10 Calibration Procedures and Tests oooooooccoccoccocccocororo o 4 10 Annual Proced res cesses ga ed eske aan 4 10 Parameter Test Proced
3. H ier o 258 50 5500 n 00 00 300 50 solos moi Figure 1C Cuff Oscillation From A Clinical Measurement Invasive Pressure Cuff Pressure What Do Simulator Manufacturers Say The DNI Nevada Fluke Biomedical CuffLink manual states Since the CuffLink produces the same response independent of the inflate deflate cycle or the algorithm used by the monitor we offer the term Target Value as an approximation of the patient s actual blood pressure 5 B 4 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Appropriate Use of NIBP Simulators Appropriate Use of NIBP Simulators Why Use Simulators Summary BioTek NIBP Pump 2 Fluke Biomedical manual in response to the question of why monitor readings differ from the target values on the simulator states Neither the monitor or the NIBP Pump 2 is broken Some monitors were designed to give readings close to those obtained by the Auscultatory method of blood pressure determinations Other monitors have been designed to agree with Invasive blood pressure readings It is well known that Invasive and Auscultatory NIBP readings on the same subject can be quite different 6 Both of these statements indicate that these simulators cannot be used to demonstrate the accuracy of an NIBP monitor Simulators provide a method for producing repeatable signals that can be used to check that the monitor is responding to noninvasive blood pressure signals Reference values
4. SpO Configuration Settings Procedure for units with Ohmeda TruSignal Technology 1 With the monitor off press and hold the Menu button at the same time as pressing the On Off button until the display test completes Press the Menu button until LF appears in the Pulse Rate window Use the buttons to select the option To exit the configuration mode turn the unit off To continue with additional configuration settings press the Menu button CAUTIONS The LF mode must be set according to each country s electrical power utilities implementation The LF mode must be checked and reset any time the monitor is set to or reverts to factory default settings If the LF mode is set incorrectly the susceptibility to ambient light is increased and low perfusion performance may be effected resulting in inaccurate readings Procedure for units with Nellcor Technology 1 With the monitor off press and hold the Menu button at the same time as pressing the On Off button until the display test completes Press the Menu button until nOd response mode appears in the Pulse Rate window Use the buttons to select the option Press the Menu button once SAt SatSeconds appears in the Pulse Rate window Use the buttons to select the option CARESCAPE V100 Vital Signs Monitor 2037106 001 B Installation Configuring Your V100 Monitor 6 To exit the configuration mode turn the unit off To conti
5. 20 box NOP Disposable LNOP Disposable LNOP Blue 2027273 001 SpO Sensor Masimo L NOP Reusable Finger Sensor LNOP DCIP Pediatric 2002799 001 SpO Sensor Masimo LNOP Reusable Finger Sensor LNOP DCI Adult 2002800 001 LNOP DCI SpO gt Sensor Masimo LNOP Reusable Multisite Sensor LNOP YI 2010463 001 SpO Sensor Masimo L NOP Reusable Tip Clip Ear Sensor LKNOP TC I 2027274 001 SpO Sensor Masimo L NOP Reusable Finger Sensor Adult DC 195 2009745 001 SpO Sensor Masimo L NCS DCI Reusable Adult Sensor 2027258 001 SpO Sensor Masimo L NCS DCIP Reusable Pediatric Sensor 2027259 001 SpO Sensor Masimo L NCS TC I TipClip Reusable Ear Sensor 2027261 001 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 5 Parts List Drawings and Replacement Service Parts Part Part description Part number SpO Sensor Masimo LNCS Adult Transparent Adhesive Sensor 20 box 2027253 001 SpO Sensor Masimo LNCS Pdtx Pediatric Adhesive Sensor 20 box 2027254 001 SpO Sensor Masimo LNCS Inf L Infant Adhesive Sensor 20 box 2027255 001 SpO Sensor Masimo LNCS Neo L Neonatal Adhesive Sensor 20 box 2027256 001 SpO Sensor Masimo LNCS NeoPt L Neonatal PT Adhesive Sensor 20 box 2027257 001 SpO Cable Assy 2 4M Masimo LNOP SpO
6. MLPOGUCTION RE 2 8 Overall Principles of Operation 0c kaka aa 2 8 SPO2 EET 2 9 Cuff Blood Pressure NIBP and Pulse lt 2 9 DINAMAP SuperSTAT Algorithm aaa 2 10 SYStOllE SEdrCA A ana near ee 2 11 DINAMAP Classic and Auscultatory Reference Algorithm 2 12 SYSTOIIE SEALEN uuu u een iss sap lana 2 13 Reference Used to Determine NIBP Accuracy lt 2 13 CARESCAPE V100 Monitors With Intra Arterial Reference DINAMAP SuperSTAT and Classic Technology 2 14 CARESCAPE V100 Monitors With Auscultatory Reference DINAMAP Auscultatory Reference Technology 2 14 Temperdture tc al mess EDS 2 14 Host Communication Port isses 2 14 Functional Description kaka aka ak 2 14 Main Boara PWA nn a da ERE a a 2 15 User Interface UI Board PWA Lai aaa aaa 2 15 SPOZLPWA nee park ii sa di a8 ai dien 2 16 Prinltet Los ana ran nur RR RR 2 16 Prie rridtics s roue ne ia 2 16 Optical Switch oto erre er ete eere A A 2 16 CARESCAPE V100 Vital Signs Monitor 2037106 0018 Installation 3 1 Connections sn AAA ee 3 3 RIGHL SIGE Panel t ta atto na 3 3 RE nd nian 3 3 Powering the Monitor un ca os aan 3 4 POWER SOUFEBS nu A en ER ad Rai 3 4 B ttery Chargingis mens getan era 3 4 BATTERK OK E an ia aaa duae EE ra Des E M t 3 5 Battery Aldrms etie pie a dias 3 5 ELS Battery LOWS ee a EASA A aa 3 6 Unpacking and Preparation for Installation
7. The CARESCAPE V100 Vital Signs Monitor is protected PX 1 against vertically falling drops of water and conforms with the IEC 529 standard at level of IPX1 Vertically falling drops shall have no harmful effects to the Monitor 1 8 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Introduction Service Requirements Service Requirements Follow the service requirements listed below m Refer equipment servicing to GE Medical Systems Information Technologies authorized service personnel only m Any unauthorized attempt to repair equipment under warranty voids that warranty m tisthe user s responsibility to report the need for service to GE Medical Systems Information Technologies or to one of GE s authorized agents m 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 m Regular maintenance irrespective of usage is essential to ensure that the equipment will always be functional when required Equipment ID The following graphic illustrates the components of the monitor s serial number GEMS IT Global Serial Number Format 13 Digit HHH HH HH HHH HH Misc Prototype refurbish etc Manufacturing site Sequential serial number up to 9999 Fiscal week Year 3 character product code Intended Audience This manual is intended for service representativ
8. 1 minute For soil on the soft part of the closure or the cuff itself wipe the material off with a soft cloth For persistent contamination on the soft part of the closure use a soft bristled brush to loosen particles Rinse with copious amounts of distilled water Repeat until no visible contamination remains For soil on the hook part of the closure use a soft bristled brush to remove the material and rinse with copious amounts of distilled water Repeat until no visible contamination remains Spray the 1096 bleach solution on the affected area until the area is saturated Allow the cuff to sit for 5 minutes Wipe away any excess solution and rinse the cuff again with distilled water Allow 2 hours for drying NOTE The user has the responsibility to validate any deviations from the recommended method of cleaning and disinfection 2037106 001 B CARESCAPE V100 Vital Signs Monitor 4 5 Maintenance Long Term Storage Temperature Devices SpO Sensors For additional information on infection control procedures contact GE Medical Systems Information Technologies Technical Support Do not immerse predictive temperature probes The probe may be cleaned with a solution of 10 bleach in water Use a cloth or sponge just damp not wet and avoid getting any liquid into the interior of the probe Adhesive sensors are sterile and for single use only Reusable sensors should be cleaned before reuse with a 7096 alcohol solutio
9. 2 4 m 2017002 003 SpO Cable Assy 3 6M Masimo LNOP SpO gt 3 6 m 2017002 001 SpO Cable Assy 3M Masimo LNC 10 SpO gt 3 m 2027263 002 SpO Accessory Masimo Replacement Posey Wrap LNOP NeoPt L Neonatal 12 box 2010466 001 SpO Accessory Masimo Tape Bag for LNOP NEO 100 box 2010467 001 SpO Accessory Masimo Tape Cleanshield Multisite LNOP YI 100 box 2010468 001 SpO Accessory Masimo Disposable Standard Multisite Wrap Adult Ped Neonatal Adhesive Attachment Wraps use with LNOP Y Multisite Reusable Sensor 100 box 2010469 001 SpO Accessory Masimo Tape Standard Petite Wrap LNOP YI 100 box 2010470 001 SpO Accessory Masimo Adhesive Tape for LNOP VI 12 box 2010471 001 Temperature Alaris Temperature Oral Probe Sensor Turbo Temperature Long White Cord 2008774 001 Alaris Temperature Rectal Probe Sensor Turbo Temperature Long Rectal White Cord 2008775 001 Alaris Probe Covers Probe covers 20 box 615118 Power Battery Battery Lead Acid 6 V 3 0Ah 633178CR 12W Power Supply Power supply Universal 12W 100 250VAC 12VA 2018859 001 Printer Replacement Paper Printer paper roll 10 box 089100 Mounting Options Roll Stand Rollstand CARESCAPE GCX Version 2033297 001 Pole Mount Pole Mount 2009762 001 Power Supply Mo
10. 2037106 001 B Maintenance Long Term Storage Battery Care If it becomes necessary to store the Monitor for an extended period of time first fully charge then remove the battery Then store the Monitor and the battery in the original packaging materials Batteries should always be fully charged before being placed in storage Batteries should not be left in storage more than 6 months without removal and full recharge A fully charged battery in good condition will provide sufficient power to operate a Monitor for approximately 8 11 hours depending upon configuration and use It is best to keep the battery charged as fully as practical and never store the Monitor with the battery in a discharged condition When the battery will no longer hold a charge remove and replace it Failure to replace the battery with the same GE Medical Systems Information Technologies part number may result in shorter battery life Battery charging will take place as long as the Monitor remains connected to an external DC power source NOTE After replacing batteries an E00 error code is normal The user settings and date time revert to the factory default setting CAUTIONS To ensure that the battery will be ready for portable operation keep the Monitor connected to a mains supply whenever possible Repeated failure to fully charge the battery will result in a significant reduction in battery life The expected lifetime of the battery largely
11. Installation Unpacking and Preparation for Installation After plugging the monitor into DC power The BATTERY LOW indicator when the monitor is on and CHARGING indicator illuminate The BATTERY LOW indicator turns off when the battery level reaches a sufficient charge level to operate without the BATTERY LOW alarm active E13 Battery Low At any time while the high priority BATTERY LOW alarm is active certain actions can trigger the E13 BATTERY LOW alarm any attempt to start an NIBP determination or a printout This alarm is giving you additional warning that the battery charge is critically low NOTE At this time it is highly recommended to plug the monitor into external DC power The E13 error code appears in the min window The BATTERY LOW indicator flashes This alarm can be silenced by pressing the Silence button The user is not able to initiate 999 any new NIBP determinations of any type any printouts Unpacking and Preparation for Installation Unpack and identify the contents of all shipping materials Remove the V100 Monitor Unpack the AC cord Fun p Plug the AC cord into the AC Mains input on the external power supply and plug the supply DC output into the back of the Monitor 5 Plugthe AC cord into a Hospital Grounded AC receptacle The word CHARGING will illuminate green on the front of the Monitor indicating that an AC source is available Prior to usage it is necessary to charg
12. Masimo LNOP SpO cable assembly 24m 7 9 ft 2037106 001 B CARESCAPE V100 Vital Signs Monitor C 7 Electromagnetic Compatibility EMC Electromagnetic Compatibility EMC CARESCAPE V100 Monitor Part No Description ee 2002800 001 Masimo LNOP Reusable Finger Sensor LNOP DCI Adult 1 0 m 3 3 ft 2027263 002 Masimo LNC 10 cable assembly 3 0m 10ft 2002799 001 Masimo LNOP Reusable Finger Sensor LNOP DCI Pediatric 1 0m 3 3 ft 2027258 001 Masimo LNCS Reusable Adult Sensor Not Specified 2010458 001 Masimo Disp Adhesive Sensor LNOP ADT Adult 20 box Not Specified 2010459 001 Masimo Disp Adhesive Sensor LNOP PDT Pediatric 20 box Not Specified 2010461 001 Masimo Disp Adhesive Sensor LNOP NeoPT Neonatal 20 box Not Specified 2010460 001 Masimo Disp Adhesive Sensor Bridge LNOP NEO Neonatal 20 Not Specified box 2017089 001 Masimo Disp Adhesive Sensor LNOP Neo L Neonatal 20 box Not Specified 2017090 001 Masimo Disp Adhesive Sensor LNOP NeoPT L Neonatal 20 box Not Specified 2027269 001 Masimo Disp Adhesive Sensor Transparent Tape LNOP Adult 20 Not Specified box 2027270 001 Masimo Disp Adhesive Sensor Transparent Tape LNOP Pediatric Not Specified 20 box 2027271 001 Masimo LNOP Disposable LNOP Hi Fi Sensor Neonatal Adult 20 Not Specified box 2027272 001 Masimo LNOP Disposable LNOP Hi F
13. Parts List Drawings and Replacement Ordering Parts Ordering Parts Service Parts Compatible Parts This section of the manual provides parts lists for the V100 Monitor Parts lists should be used in conjunction with the other chapters of this manual GE makes every effort possible to provide the most up to date reference documentation for your equipment However in special cases involving field installed upgrades the revision level of a diagram or parts list in this manual may not reflect the revision level of your unit s subassemblies When discrepancies are found contact your GE Medical Systems Information Technologies Service Representative NOTE Fab drawings are not contained in this manual Part Part description Part number NIBP NIBP Adult 12ft Air hose adult ped 12 ft gray 107365 NIBP Neonate 12ft Air hose neonatal 12 ft light blue 107368 NIBP Adult 24ft Air hose adult ped 24 ft gray 107366 NIBP Cuff Classic Cuff Neonate Classic Cuf assortment pack neonatal 2 tube M slip 2693 NIBP Cuff Classic Cuff Various Classic Cuf assortment pack various 2 tube screw 2692 NIBP Cuff Soft Cuff Various Soft Cuf assortment pack various 2 tube screw 2695 NIBP Cuff Soft Cuff Neonate Soft Cuf assortment pack neonatal 2 tube M slip 2694 NIBP Cuff Dura Cuff Adult Dura Cuf assortment pack adult 2 tube screw 2698 NIBP Cuff Dura Cu
14. V100 Fascia Kit POL FRU 2037103 039 CARESCAPE V100 Fascia Kit POR CONT FRU 2037103 040 CARESCAPE V100 Fascia Kit RU FRU 2037103 041 CARESCAPE V100 Fascia Kit SLO FRU 2037103 042 CARESCAPE V100 Fascia Kit SP FRU 2037103 043 CARESCAPE V100 Fascia Kit SWE CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Service Parts FRU 2037103 022 CARESCAPE V100 All Hardware Kit NOTE Each Hardware kit includes the following Description QTY ADHESIVE BACKED CABLE TIE MOUNT 75X 75 5 CABLE TIE LOCKING NYLON 6 6 3 1 X0 09 5 CABLE TYE WRAP 10 CONN PLASTIC TEE 4 EXTRUSION GROMMET HANDLE 3 FILTER 40 MICRON 10 FOOT RND 12 7 DIA X 3 5H SELF ADHSV 20 KIT SCREWLOCK FEMALE WITH THREAD LOCK 3 SCREW M3X12 SELF TAP TORX 20 SCREW MACH PNHD 832X2 1 2 SS VIBRATITE 6 SCREW MACH PNHD PHIL 440X3 16 SS VIBRATITE 20 SCREW NO6 TORX PAN 1 0 INCH VIB 4 SCREW SELF TAP TORX ZINC 20 SCREW SELF TAP TORX ZINC 3 SCREW NO8 POZI PAN 75IN VIB 20 SPACER STEEL ZINC 20 SPEAKER CLAMP RING 3 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 19 Parts List Drawings and Replacement Service Parts Description QTY STANDOFF MASIMO SpO 4 STANDOFF NELLCOR SpO 4 STANDOFF OHMEDA SpO2 4 TUBING SILICONE 1 8ID X 1 40D 1 foot TUBING SILICONE CLEAR 3 32
15. Vital Signs Monitor 2037106 001 B C Electromagnetic Compatibility EMC For your notes C 2 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Electromagnetic Compatibility EMC Electromagnetic Compatibility EMC CARESCAPE V100 Monitor Electromagnetic Compatibility EMC CARESCAPE V100 Monitor Changes or modifications to this system not expressly approved by GE Medical Systems can cause EMC issues with this or other equipment This system is designed and tested to comply with applicable regulation regarding EMC and must be installed and put into service according to the EMC information stated in this appendix CAUTION Use of portable phones or other radio frequency RF emitting equipment near the system may cause unexpected or adverse operation The equipment or system should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the equipment or system should be tested to verify normal operation in the configuration in which it is being used Guidance and Manufacturer s Declaration Electromagnetic Emissions The V100 Monitor is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to assure that the V100 Monitor is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions Group 1 The equipment uses RF energy only for its internal fun
16. accuracy has been established using an invasive central aortic blood pressure reference More recently the CARESCAPE V100 Monitor has also been validated against a manual auscultatory reference Clinical vs Simulator Readings There are a number of reasons why the clinical studies are required for the measurement of NIBP accuracy Many physiologic measurements e g ECG HR eTCO2 can be taken with little interaction between the monitor and the patient These devices can typically be validated using previously recorded patient data Unlike the transducers electrodes used in these devices the NIBP cuff has two functions In addition to sensing the pressure pulses in the cuff the cuff occludes and then releases the patient s artery to create the conditions that allow blood pressure to be measured An artificial arm would need to test both the sensing and occluding functions of the cuff and mimic the nonlinear dynamics of the artery to provide an effective clinical simulation While this has been attempted 4 there are no effective arms available Commercial NIBP simulators do attempt to test both functions of the NIBP cuff Pressure signals are generated by the simulator in response to the inflation and deflation cycles of the monitor While the cuff may be in the system it is wrapped on a mandrel The ability of the cuff to transducer pressure signals or to occlude the artery is not tested There are further limitations to the pre
17. covers The size shape and thermal characteristics of the probe covers can affect the performance of the instrument Inaccurate readings or retention problems may occur unless IVAC probes and probe covers are used Refer to Appendix D for reorder codes Battery Battery Specifications Capacity 6V 3 3 Ahr sealed lead acid battery Battery life 8 1 hours standard deviation of 0 46 with a usage scenario of NIBP determinations every 15 minutes with SpO and temperature active 11 5 hours standard deviation of 0 53 non SpO versions with a usage scenario of NIBP determinations every 15 minutes with temperature active Charge time Approx 5 hours from full discharge when the monitor is off Approx 8 hours when the monitor on Default Settings Alarms Alarm volume 5 NIBP Non Adult ped Neonate patient specific Systolic mmHg HIGH 200 100 LOW 80 40 Diastolic mmHg HIGH 120 60 LOW 30 20 A 12 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Technical Specifications and Default Settings Default Settings Ohmeda SpO Nellcor SpO Masimo SpO gt Temperature Inflation pressure 160 100 for Auscultatory Inflation pressure 135 100 for SuperSTAT Inflation pressure for Classic 160 110 Cycle button default 15 min SpO 96 HIGH alarm limit 100 SpO 96
18. depends on the way in which the Monitor is used Never fully discharge the battery To prolong battery life connect the Monitor to AC power source when not in use 2037106 001 B CARESCAPE V100 Vital Signs Monitor 4 7 Maintenance Long Term Storage Replacing the Battery 1 Unplug the Monitor from the DC power source 2 Looking at the bottom of the V100 Monitor remove the battery compartment cover by removing the four screws that secure the cover and help card tray 3 Remove the help card tray and battery door cover 4 Remove the old battery and disconnect the wires Attach the battery wires to the new battery ensuring the red terminal 4 is connected to the red wire and the black terminal is connected to the black wire 5 When reconnecting battery power the monitor enters fatal mode To clear the alarm press the On Off button 6 Insert the battery into the compartment 7 Then replace the cover help card tray and screws Insert the external DC power converter plug into the external DC power socket and plug into an AC outlet NOTES Error code E00 appears MEMORY LOST alerting you that the user settings including alarm limits and inflation pressure and date time will go back to default values Configured settings and time date will NOT be lost when reset due to pressing and holding the On Off button regardless of whether the DC charger is attached Configured settings and ti
19. digits MAX I 2 digits MAX FAST 2 digits SC A adult 2 digits 2037106 001 B CARESCAPE V100 Vital Signs Monitor A 7 Technical Specifications and Default Settings Specifications Specifications Nellcor sensor accuracy SC PR neonate 3 digits SC NEO 3 digits MAX R 3 5 digits OxiCliq OxiCliq A 2 5 digits OxiCliq P 2 5 digits OxiCliq N adult 2 5 digits OxiCliq N neonate 3 5 digits OxiClig 2 5 digits Reusable sensor models D YS infant to adult 3 digits D YS neonate 4 digits D YS D YSE 3 5 digits D YS amp D YSPD 3 5 digits DS 100A 3 digits OXI A N adult 3 digits OXI A N neonate 4 digits OXI P I 3 digits Neonatal sensor accuracy When sensors are used on neonatal subjects as recommended the specified accuracy range is increased by 1 digit as compared to adult usage to account for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood For example MAX N accuracy on neonates is 3 digits rather than 2 digits Sensor light source Wavelength Infrared 890 nm nominal Red 660 nm nominal Power dissipation Infrared 22 5 mW max Red 30 mW max The MAX N D YS OXI A N and OxiCliq N were tested on patients gt 40 kg The accuracy specification has been determined between saturations of 80 100 Informatio
20. from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above the equipment should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the equipment POver the frequency range 150 KHz to 80 MHz field strengths should be less than 3 V m 2037106 001 B CARESCAPE V100 Vital Signs Monitor C 5 Electromagnetic Compatibility EMC Electromagnetic Compatibility EMC CARESCAPE V100 Monitor Recommended Separation Distances The table below provides the recommended separation distances in meters between portable and mobile RF communications equipment and the V100 Monitor The V100 Monitor is intended for use in the electromagnetic environment on which radiated RF disturbances are controlled The customer or the user of the V100 Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the V10
21. jn d8 Suiqn1 lt gt IO 9q0J4 20ds WDADDIG 190 89 HUN 2 17 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Equipment Overview Functional Description 2 18 CARESCAPE V100 Vital Signs Monitor 2037106 001 B 3 Installation For your notes 3 2 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Installation Connections Connections Right Side Panel 1 External DC power socket used with approved GE Medical Systems Information Technologies AC DC power converter ONLY pm Rear Panel C 2 Datainterface connector host communications port 15 pin D type RS 232 serial port for use only with equipment conforming to IEC 60601 1 configured to comply with IEC 60601 1 1 3 Printer door 2037106 001 B CARESCAPE V100 Vital Signs Monitor 3 3 Installation Connections Powering the Monitor Power Sources Battery Charging The V100 Monitor is designed to operate from an internal lead acid battery NOTE The V100 Monitor is not designed to operate without a functional internal battery Prior to each use inspect the power supply cord to ensure proper connection and condition With external DC power connected the green CHARGING indicator will light to indicate that the battery is charging This indicator remains active whether the unit is on or off An audible two beep sounds whenever the DC charger is connected disconnected Battery charging will
22. obtained from a particular make and model of an NIBP monitor can be used to confirm that no changes have occurred after service to that same type of monitor Simulators can also be used to test for leaks and conduct static pressure calibration of NIBP monitors and as part of preventive maintenance programs The accuracy of an NIBP monitor can only be determined by comparison to a clinical blood pressure reference NIBP simulators are useful for certain types of testing but should not be used for accuracy testing Figure 2A Cuff Oscillation From A Clinical Measurement 2037106 001 B CARESCAPE V100 Vital Signs Monitor B 5 Figure 2B Cuff Oscillation From A Simulator Measurement References 1 FDA CDRH Non Invasive Blood Pressure NIBP Monitor Guidance March 10 1997 2 ANSI AAMI SP10 2002 Manual Electronic or Automated Sphygmomanometers 3 EN 1060 4 2004 Specification for non invasive sphygmomanometers Part 4 Test procedures to determine the overall system accuracy of automated non invasive sphygmomanometers 4 Mieke S Substitute of simulators for human subjects Blood Press Monit October 1 1997 2 5 251 256 5 DNI Nevada CuffLink Non Invasive Blood Pressure Analyzer Operating and Service Manual Revision E 11 97 6 NIBP Pump 2 Noninvasive Blood Pressure Simulator and Tester Operations Manual Revision C January 2003 Bio Tek and NIBP Pump 2 are trademarks of Bio Tek Instruments CARESCAPE V100
23. or pole mounted Portability Carried by recessed handle Power requirements Power converter universal P N 2018859 001 Protection against electrical shock Class II AC input 100 to 250VAC 12VA DC output voltage 12VDC at 1A The AC mains power adapter contains a nonresettable and nonreplaceable fuse Monitor Protection against electrical shock Internally powered or Class II when powered from specified external power supply DC input voltage 12 VDC supplied from a source conforming to IEC 60601 1 Fuses The monitor contains three fuses The fuses are mounted within the monitor The fuses protect the low voltage DC input the battery and the remote alarm output The 5 V output on the host port connector is regulated by internal supply Battery Refer to Battery Section Environmental Operating temperature 5 C to 40 C 41 F to 104 F Operating atmospheric pressure 700 hPa to 1060 hPa 2037106 001 B CARESCAPE V100 Vital Signs Monitor A 3 Technical Specifications and Default Settings Specifications General Specifications Storage transportation Storage temperature 20 C to 50 C 4 F to 122 F Atmospheric pressure 500 hPa to 1060 hPa Humidity range 5 to 95 noncondensing Radio frequency Complies with IEC Publication 60601 1 2 2004 Medical Electrical Equipment Electromag
24. power sequentially to the two stepper motor windings Together these signals CONTROL DATA cause the printer to print a graphic hardcopy of the patient vital sign values and trend data It also causes the printer to print a hardcopy of error logging and service record data The printer has a built in sensor to monitor the printer paper presence When the printer is out of paper it sends a PAPER OUT signal to the primary processor The pneumatics consists of a pump a deflate valve and a dump valve The pneumatics inflates deflates the cuff during NIBP determinations During normal operation the pneumatics are controlled by the primary processor If a failsafe mode or overpressure condition occurs the NIBP processor provides the appropriate control signals to insure a safe condition where the cuff vents to ambient atmosphere pressure The optical switch indicates whether the temperature probe is inserted in the probe holder or not The Main Board powers the switch CARESCAPE V100 Vital Signs Monitor 2037106 001 B Equipment Overview Functional Description D JOQ O1 UOD Kisnog A9 IQ DUJ81X3 p4bog IN 92DJJ91U Je ug Jaq A ddns samod 20 payojos Jayoads o 3u02 olpny 011u0 dua 1 0 00 d8IN 1d T ld p IDOY UIDIN WUD ajouway 292 1031 1104 Sy DIDQ JOMUO WWOD ISOH u21IMS pando puondo D109 104Ju0 dwaL agolg duis pJOHUB a3ADA AUNG
25. print an error log that stores up to 40 error code entries The log is a rolling list that once 40 entries are stored deletes the oldest entry in order to add the most recent entry The error log is saved until the monitor experiences a memory loss then all entries are deleted Procedure to View and Print Error Code History Log 1 Enter the Advanced Configuration Mode ACF by holding down the Minus and Menu buttons while powering up the monitor pressing the On Off button 2 The monitor briefly displays the software revision then displays ACF in the Systolic window 3 The monitor is now in Advanced Configuration Mode 4 Toview the error log use the History button to step through the log in reverse order of when the error occurred oldest appears first 5 The Systolic window shows the Year the error occurred 6 The Diastolic window shows the Day the error occurred 7 The MAP window shows the Month the error occurred 2037106 001 B CARESCAPE V100 Vital Signs Monitor 5 3 Troubleshooting Alarm Code Interpretation 8 The SpO window shows the Time the error occurred 9 The Pulse Rate window shows the error code that occurred at the recorded time 10 To print the error log press the Print button while viewing the log 5 4 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Troubleshooting Alarm Code Interpretation Error Codes
26. the instruction cards DITS 2 Remove the battery compartment door and adhesive pad 3 The battery can now be removed 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 29 Parts List Drawings and Replacement Assembly Disassembly of FRUs Rear Case 1 Remove remaining two screws from the bottom of the monitor 2 Setmonitor upright 3 Carefully remove the front faceplate 4 Remove screws behind black overlay 5 Setmonitor on its face and open the printer door 6 Carefully remove the rear case 7 Unplug speaker cable and temperature module cable if installed from circuit board 6 30 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Assembly Disassembly of FRUs Printer 1 Liftthe 2 black tabs and remove printer cable 2 Remove printer assembly 3 Unplug air hose from valve and filter 4 Remove remaining 3 cable assemblies 5 Locate and release retention tab and slide back sub chassis 6 Remove sub chassis and set aside 7 Remove pneumatic assembly from sub chassis 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 31 Parts List Drawings and Replacement Assembly Disassembly of FRUs SpO Board 1 Remove 2 screws securing SpO gt board NOTE Threaded standoffs have screws on both ends 2 Remove SpO gt board Front Bezel 1 Remove 2 SpO connector screws 2 Unplug 2 pneumatic hoses from bezel
27. to 3 cm in induced hypoxia studies in the range of 70 100 SpO against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 6896 of the population 1The Masimo SET SpO parameter with LNOP Neo Pt sensors has been validated for neonatal motion accuracy in human blood studies on neonates while moving the neonate s foot at 2 to 4 cm against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 6896 of the population The Masimo SET SpO parameter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 stimulator and Masimo s simulator with signal strengths of greater than 0 0296 and a 96 transmission of greater than 596 for saturations ranging from 70 to 100 This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 6896 of the population Specifications Masimo sensor accuracy SpO range S del ensor mode 70 to 100 LNOP LNOP ADT 2 digits without motion LNOP NEO 3 digits without motion 2037106 001 B CARESCAPE V100 Vital Signs Monitor A 9 Technical Specifications and Default Settings Specifications Specifications Masimo sensor accuracy LNOP NEO L Foot 3 digits without m
28. with the V100 Monitor are used CARESCAPE V100 Vital Signs Monitor 2037106 001 B Introduction Equipment Symbols Equipment Symbols The following symbols are associated with the V100 Vital Signs Monitor NOTE The model of the monitor determines which symbols appear on it A Attention consult accompanying documents idmeovoooveooess gt Silence Alarms Increase decrease adjustable settings Menu Inflate Stop Cycle History Print On Off External communications port connector Battery Power Charging External DC power input Class Il equipment according to IEC 60536 Defibrillator proof type BF equipment 2037106 001 B CARESCAPE V100 Vital Signs Monitor 1 7 Introduction Equipment Symbols Manufacturer This symbol is accompanied by the name and the address of the manufacturer Manufacturing Date This symbol is accompanied by the date of the manufacturing ree European authorized representative Te 500hPa Packaging label depicting the transportation and storage atmospheric pressure range of 500 to 1060 hPa 1060hPa WASTE OF ELECTRICAL AND ELECTRONIC EQUIPMENT WEEE This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment
29. 0 Monitor as recommended below according to the maximum output power of the communications equipment Separation Distance in Meters m According to Frequency of Transmitter Rated Maximum Output Power of Transmitter in 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 12VP d 12VP d 23VP Watts 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equitation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE These guidelines may not apply in all instances Electromagnetic propagation is affected by absorption and reflection from structures objects and people C 6 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Electromagnetic Compatibility EMC Electromagnetic Compatibility EMC CARESCAPE V100 Monitor Compliant Cables and Accessories CAUTION The use of accessories transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the equipment or system The table below lists cables transducers and other
30. 1 of 16 decoder demultiplexer one at a time and then reads at the signal on SW MUX A LOW on SW MUX indicates that the switch is asserted 2037106 001 B CARESCAPE V100 Vital Signs Monitor 2 15 Equipment Overview Functional Description SpO PWA Printer Pneumatics Optical Switch The V100 Monitor can be configured for use with either a Ohmeda Nellcor or Masimo SpO gt PWA The SpO PWA provides continuous readings of oxygen saturation and pulse rate Additional circuitry on the Main Board provides power data communications and isolation between SpO gt PWA and primary processor Patient data received from the finger sensor is filtered amplified and analyzed on the SpO PWA The information is sent to the Main Board via the optically coupled electrically isolated serial connection The primary processor receives the data and routes it to the UI board for display The data is also sent to the printer if specified The printer receives power from the Main Board and communicates with the primary processor Printer presence and print head temperature is indicated by PR TH signal to the primary processor When a print command is sent to the printer from the primary processor the following will occur PR CLK signal transfer the data into print head PR DI signal serial dot to be printed PR LAT signal latch the data stream into the head PR ST1 6 cause the head to print various sections PR M1 4 signals control
31. 114 nous 03SN LAN ATNO 4 NO IVIN3INO Q31VULSNTI NI Q311VISNI 38 1SnW s INVINOdNI LON SI NOIAIVIN3IMVO un220 IM 3SV2 vI HLIM 32N3833831NI YO NOIIVIN3INO XOuddV JHL NI 97 2 40 39NVU NOISN3I V OL N3LSV4 A138N9IS 38 TIVHS 311 dIZW LNVLYOdNI LON SI ALIYWIOd 3801vV33i NOILN3134 YOLIINNOS HLIM NO9I V SGYUVB NOILN3L34 Nid LIVLNOI 40 NOILVINIIUO ONIUNSNI YOLIFNNOD dW d OLNI SNId LOVLNOD QV31 3YIM JAVA dWnQ 1YISNI 5 m S OT81 NI 9 W N 8 9 0 OL 3NOYOL S 0F81 NI v W N 2659 0 OL 3NOYOL z xwenissvens wainiue 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 24 Parts List Drawings and Replacement 13077 JONN 11635 390v4 NO 310v1 11M 130v 335 1N30N3430 3OvnoNY SQ v2 13m 138v1 QILNIYd M N 403 Nu3QlAOUd 3D1AY3S 1V201 YNOA 12VINOD YO 3Sn3sy ONV JAON3Y S138V1 YIBGANN IVIYIS ONY 1300N 1V3H H3AO2 OL 3YIHOV ONY 3dVL 3 S3HQV HOYA 9NIXOVGB S 0781 NI 8 W N v06 0 OL NMOHS NOI1V2O XOUuddV NI v U3A02 OL ONY 3dVl JAISIHOV HOYA 9NIMOVB JAOM3Y 3NOYO1 3u3HQV 3AOWI3Y TVNIWY3l G38 Ol 318VO Q38 ALIYVIOd JLON 31849 A8311V8 Ol AYILIVO 123NNOO NBOHS NO I1V2O 31VM XONAdY Ni 1301 JWI 138Y1 YIGNON 1Y183S ONY 1300 6 25 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement UL awos 35V2 1083 8 ININNDI TY WMA 310M QuvOg NIVA HLIM OJONTINI NOIL
32. 1D 7 32 OD 1 foot WSHR 10 FENDER WASHER 1 00 OD STAINLE 4 FRU 2037103 022 CARESCAPE V100 Keypad Kit NOTE Printer version shown For non printer versions the print key will need to be trimmed before installation See FRU installation instructions and parts drawing for further details CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Service Parts FRU Main Reference Guide Drawing For quick reference use the following FRU Main Reference Guide drawing 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 21 Parts List Drawings and Replacement Service Parts wm wo oo H H m m gt 2 o o EB E gt o c e rf o wz o o ro x z oo JE o o o a a See iw zo us Las ou 22 z gt o o Bs c o o r Za EELEE sh NOS ik A N N IN S RE ANY WEE AN CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Service Parts QJLVYLSNANTI Sv 9NOL DI 1SVI4 SdV183AO 3AOHNO9 JTIONVH 3UNSN3 HILON HLIM NOI TW ONY 1349VY8 HONOYHL SYOLINANOI YIAVIAS 0334 S O TB1 NI 8 W N v06 0 OL 3NOYOL 7 S O B1 NI 9 W N 819 0 OL 3NOYOL Y gt gt E CL NN LEA 6 23 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement
33. 3 Remove 4 torx head screws along the bottom of main board 4 Liftunitand remove bezel 6 32 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Assembly Disassembly of FRUs Main Board 1 Remove 5 torx head screws Display Board 1 Carefully lift the Main board away from the UI board 2 Collect the 5 spacers used to align the Main and UI board 3 Liftthe UI board away from the front panel qz ai io 4 The monitor is now completely disassembled 5 Reverse the above sequence to reassemble the monitor 6 Be careful not to pinch any cables or tubing during reassembly NOTE Updated Instructions may be included in your replacement parts kit always review all material included in your kit 2037106 001 B CARESCAPE V100 Vital Signs Monitor Parts List Drawings and Replacement Assembly Disassembly of FRUs 6 34 CARESCAPE V100 Vital Signs Monitor 2037106 001 B A Technical Specifications and Default Settings For your notes A 2 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Technical Specifications and Default Settings Specifications Specifications General General Specifications Mechanical Dimensions Height 7 7 in 19 5 cm Width 8 6 in 21 9 cm without temperature 10 0 in 25 4 cm with temperature Depth 5 3 in 13 5 cm Weight Including battery 5 4 Ib 2 4 kg Mountings Self supporting on rubber feet
34. 37103 056 FRU CARESCAPE V100 BATTERY X5 BATTS All SpO technology labels included Select applicable label per monitor configuration Main boards configured with SuperSTAT NIBP algorithm Nellcor SpO5 and Temperature enabled Reconfigure as applicable per monitor configuration Refer to Installation Section 3 for more details All UI board LEDs installed Cover LEDs with applicable fascia per monitor configuration d Check valve has directional arrow indicating correct orientation for assembly Fully charge battery before initial use Refer to Installation Section 3 for more details f Kit includes all versions of fascia and display covers Install per monitor configuration 9 Remove Print button for non printer versions of monitor Refer to following assembly drawings 6 10 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Service Parts FRU Photos FRU 2037103 003 CARESCAPE Plastic Kit W Printer NOTE Rear case with printer shown FRU 2037103 004 CARESCAPE V100 Temperature Kit 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 11 Parts List Drawings and Replacement Service Parts FRU 2037103 005 CARESCAPE V100 Printer Assembly FRU 2037103 006 CARESCAPE V100 BZL BP ONLY FRU 2037103 052 CARESCAPE V100 BZL BP TEMP FRU 2037103 053 CARESCAPE V100 BZL BP SpO FRU 2037103 054 CARESCAPE V100 BZL BP
35. 50 Fax 86 21 5208 2008 GE Medical Systems Information Technologies a General Electric Company going to market as GE Healthcare www gehealthcare com
36. 6 001 B CARESCAPE V100 Vital Signs Monitor 6 15 Parts List Drawings and Replacement Service Parts GHS DER LL e ema e FRU 2037103 016 CARESCAPE V100 Battery X1 BATT FRU 2037103 056 CARESCAPE V100 Battery X5 BATTS FRU 2037103 017 CARESCAPE V100 Speaker CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Service Parts FRU 2037103 018 CARESCAPE V100 Cable Kit n FRU Number Description Language FRU 2037103 019 CARESCAPE V100 Fascia Kit EN FRU 2037103 025 CARESCAPE V100 Fascia Kit GER FRU 2037103 026 CARESCAPE V100 Fascia Kit CH FRU 2037103 027 CARESCAPE V100 Fascia Kit cz 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 17 Parts List Drawings and Replacement Service Parts FRU Number Description Language FRU 2037103 028 CARESCAPE V100 Fascia Kit DA FRU 2037103 029 CARESCAPE V100 Fascia Kit DU FRU 2037103 030 CARESCAPE V100 Fascia Kit FIN FRU 2037103 031 CARESCAPE V100 Fascia Kit GRE FRU 2037103 032 CARESCAPE V100 Fascia Kit GRE FRU 2037103 033 CARESCAPE V100 Fascia Kit HU FRU 2037103 034 CARESCAPE V100 Fascia Kit IT FRU 2037103 035 CARESCAPE V100 Fascia Kit JA FRU 2037103 036 CARESCAPE V100 Fascia Kit KOR FRU 2037103 037 CARESCAPE V100 Fascia Kit NOR FRU 2037103 038 CARESCAPE
37. 6 001 B Introduction Disposal of Product Waste Patient Applied Parts Packaging Material Monitor Certain patient applied parts such as those with adhesive disposable SpO gt sensors are intended for single use and should be disposed of properly as medical waste in accordance with regional body controlled guideline Other patient applied parts such as blood pressure cuffs should be cleaned according to instructions Inspect reusable applied parts for wear replace as necessary and dispose of used product as medical waste in accordance with regional body controlled guideline Retain original packaging materials for future use in storing or shipping the Monitor and accessories This recommendation includes corrugated shippers and inserts Whenever possible recycle the packaging of accessories and patient applied parts At the end of its service life the product described in this manual as well as its accessories must be disposed of in compliance with the guidelines regulating the disposal of such products If you have questions concerning disposal of the product please contact GE Medical Systems Information Technologies or its representatives 2037106 001 B CARESCAPE V100 Vital Signs Monitor 1 13 Introduction Disposal of Product Waste 1 14 CARESCAPE V100 Vital Signs Monitor 2037106 001 B 2 Equipment Overview For your notes 2 2 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Equipment Ove
38. AP SuperSTAT Auscultatory Classic m SpO Ohmeda TruSignal Nellcor or Masimo m Temperature Alaris Turbo Temp The model of the monitor determines which parameters are in your monitor Please refer to applicable sections Using the V100 Monitor a clinician can measure display and record patient vital sign data that is derived from each parameter The monitor is also capable of alerting the clinician to changes in the patient s condition or when it is unable to effectively monitor the patient s condition All of the main operations of the V100 Monitor are easy to use and only a button touch away Please review the factory default settings and where applicable enter settings appropriate for your use Overall Principles of Operation The V100 Monitor is a portable unit that receives power from an internal rechargeable Lead Acid Battery When the ON OFF button is pressed the Main Board is brought out of a sleep mode and turns on the power regulators The power regulators provide conditioned power from the Lead Acid Battery The external DC source is used only to charge the Lead Acid Battery Once the V100 Monitor is energized a self test is performed The self test automatically tests the main functions of the V100 Monitor Failure of the self test will set the V100 Monitor into a fail safe mode with an audio alarm Under normal operating conditions the V100 Monitor is ready to record the patient vital signs using three external atta
39. APE V100 Monitor C 3 Guidance and Manufacturer s Declaration Electromagnetic EMISSIONS ata ote C eet ee nennen ein S CR To C 3 Guidance and Manufacturer s Declaration Electromagnetic AM RECETTE C 4 Recommended Separation Distances lt C 6 Compliant Cables and Accessories C 7 vi CARESCAPE V100 Vital Signs Monitor 2037106 0018 1 Introduction For your notes 1 2 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Introduction Revision History Revision History Each page of this manual has a revision letter located at the bottom of the page This letter identifies the revision level of the entire manual This may be important ifyou have different manuals and you do not know which is the most current For the initial release all pages have the revision letter A For the second update all pages receive the revision letter B The latest letter of the alphabet added to the table below corresponds to the most current revision Revision Comment A Release of new manual B Updated CE marking information Manual Purpose This manual supplies technical information for service representatives and technical personnel so they can maintain the equipment to the assembly level Use it as a guide for maintenance and electrical repairs considered field repairable Where necessary the manual identifies additional sources of relevant information and technical assistance See the operator s manual for the
40. Drawing lt 6 21 Assembly Disassembly of FRUS cece cece eee e ee ee eee 6 29 Monitor Disassembly Procedure lt 6 29 A me ts Ra lab ol bath salts as ae ot RC TM 6 29 Redr CaSe in a ea 6 30 O E een E ae ER S Ree 6 31 SPO2 BGAFA its sin bete ete Dese te e 6 32 A DT 6 32 Mal Bo m 6 33 Displdy BOGE Qs sc s t teta la te dere bd as 6 33 A Technical Specifications and Default Settings caviar AL Specification A 3 GENET u ee ai Ue ER EE d A 3 PRINTER u arias A 4 NIBP ra rn BER etis A 4 OhMEAASPO2 scusa pep uns aan anal as aa ee A 5 NEellESESBO2 ae tdt po EA A 7 Less a ERDE aa aa dla aten ol o A ml elo eg A 7 MaSsIMO OI v REOR RU RR SE A 9 Temperature 4 sd ast np dent letter nd menus A 11 Battery nasser nr CREER E E e ues A 12 Default Settings dido ti end A 12 Al ros dt a dei a A 12 NIBP ou TT A 12 ONMEDA SPO iom a vt a reale A 13 Nelleor Sp92 oH ee A 13 M SIMO SDO Z tacita atender tsi an dep ln A 13 Termperat re cs eoe zr ER RR a EN er T PAM A 13 2037106 001B CARESCAPE V100 Vital Signs Monitor V Appropriate Use of NIBP Simulators B 1 Appropriate Use of NIBP Simulators oooooommmmmoo B 3 NIBP AECUFAGY ats ee er tb ed b os ta B 3 Clinical vs Simulator Readings lt B 3 What Do Simulator Manufacturers Say LL B 4 Why Use SItm lgtors anti nee as B 5 SUMMIT ras tt en NN uh imp a mn eh B 5 Electromagnetic Compatibility EMC el Electromagnetic Compatibility EMC CARESC
41. GE Healthcare CARESCAPE V100 Vital Signs Monitor Service Manual Systolic MAP Cuff Inflate Stop A ADULT NEONATE Diastolic AUTO CYCLE HISTORY amp BATTERY OK INFLATE PRESSURE Pulse Rate ALARM VOLUME BATTERY LOW PULSE VOLUME CHARGING SpO2 Temperature CARESCAPE V100 Vital Signs Monitor English 2037106 001 B paper 2007 2008 General Electric Company All Rights Reserved GE Healthcare CARESCAPE V100 Vital Signs Monitor Service Manual Systolic Inflate Stop ADULT NEONATE Diastolic AUTO CYCLE HISTORY 4 BATTERY OK INFLATE PRESSURE Pulse Rate K ALARM VOLUME C BATTERY LOW PULSE VOLUME X CHARGING bpm LOW SpO2 Temperature HIGH LOW CARESCAPE V100 Vital Signs Monitor English 2037106 001 B paper O 2007 2008 General Electric Company All Rights Reserved NOTE The information in this manual also applies to CARESCAPE V100 Vital Signs Monitor software version RAA There are no user apparent differences among these software versions Due to continuing product innovation specifications in this manual are subject to change without notice NOTE For technical documentation purposes the abbreviation GE is used for the legal entity name GE Medical Systems Information Technologies Listed below are GE Medical Systems Information Technologies trademarks All other trademarks contained herein are the property of their respective owners Ohmeda Oximetry and othe
42. LOW alarm limit 90 Line frequency mode 60 for 60 Hz SpO HIGH alarm limit 100 SpO 96 LOW alarm limit 90 Response mode 1 for Mode 1 Normal response SatSeconds 0 SpO 96 HIGH alarm limit 100 SpO gt 96 LOW alarm limit 90 Averaging time 12 seconds FastSAT mode 0 for Off Sensitivity mode 2 for Low Perfusion Unit of measure F 2037106 001 B CARESCAPE V100 Vital Signs Monitor Technical Specifications and Default Settings Default Settings CARESCAPE V100 Vital Signs Monitor 2037106 001 B D Appropriate Use of NIBP Simulators For your notes B 2 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Appropriate Use of NIBP Simulators Appropriate Use of NIBP Simulators Appropriate Use of NIBP Simulators NIBP Accuracy Noninvasive Blood Pressure NIBP monitors are approved for sale in the U S by the FDA 1 and in Europe through the CE Mark Both of these processes require that the accuracy of NIBP monitors be established through clinical testing the use of NIBP simulators is not acceptable GE Healthcare has established accuracy using the AAMI SP 10 standard 2 and a similar standard exists in Europe 3 The AAMI standard specifies that the accuracy of NIBP monitors can be determined using either an invasive intra arterial or noninvasive auscultatory blood pressure reference Over the last 30 years DINAMAP
43. LSE VOLUME Refer to Operating Modes in this section for a description of clinical mode NOTE ADULT indicator encompasses both adult and pediatric patients SpO sensor connector attach SpO cables here NIBP connector attach NIBP cuff hoses here Inflate Stop button starts a manual NIBP determination or stop any NIBP determination Temperature probe holster stores temperature probe Cycle button used to select NIBP mode of manual auto cycle or Stat mode Temperature probe cover storage stores probe covers 2 4 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Equipment Overview Front Panel 11 History button activates the history mode to view stored patient data The most recent entries are displayed first Press and hold the button for 2 seconds to clear all entries stored the adaptive inflate pressure setting returns to the configured setting Refer to the History Section of this manual for more information 12 Print button prints currently displayed values or all stored entries when in history mode 13 On Off button controls on off state of monitor push for power on and push again for power off 14 Temperature probe connector attach temperature probe cable here Front Panel Systolic Pa i MAP Cuft 24 15 gt we 93e 16 a i L Ll mr 25 E NEONATE 26 Diastol
44. PE V100 Monitor Guidance and Manufacturer s Declaration Electromagnetic Immunity The V100 Monitor is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to assure that the V100 Monitor is used in such an environment Immunity Test EN 60601 Test Level ua Electromagnetic Environment Guidance Portable and mobile RF communications equipment should not be used closer to any part ofthe equipment including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 V rms P IEC 61000 4 6 150 KHz to 80 MHz d 12 Radiated RF 3 V m 3 V m JP IEC 61000 4 3 80 MHz to 2 5 GHz d 1 2 80 MHz to 800 MHz d 23 JP 800 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol U Note 1 At 80 MHz and 800 Mhz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by reflection
45. Patient data can also be retrieved through this port For further information reference the Host Communication manual Functional Description The following paragraphs provide the functional interface relationship The V100 Monitor contains a number of electrical amp electro mechanical assemblies These assemblies are m Main Board PWA m User Interface UI Board PWA m SPO PWA optional Printer optional Pneumatic Valve Manifold PVM Optical Switch optional 2 14 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Equipment Overview Functional Description Main Board PWA The V100 Main Board is based on the NXD LPC2366 integrated microprocessor The microprocessor integrates Flash ROM RAM A D converter with input multiplexer SPI interface and timers into one chip This microprocessor is the primary processor for the V100 Monitor It services and controls the Patient Parameter Interface PPI devices printer UI Board Real Time Clock audio circuit and host communication There are three TI MSP430 secondary processors that control Power NIBP and Temperature The Power Processor controls the watchdog primary processor reset and power supply control The Power processor is powered at all times The NIBP processor controls pneumatic safety interlock timing check and NIBP control The temperature processor controls the temperature parameter Independent software in the primary and secondary processor periodically
46. SpO amp TEMP NOTE Kit includes only 1 bezel CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Service Parts FRU 2037103 007 CARESCAPE V100 Inner Chassis Kit NOTE Kit includes 4 adhesive backed feet FRU 2037103 008 CARESCAPE V100 PRTR Door X1 Rollers X5 NOTE Kit includes 1 printer door with label and 5 printer rollers 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 13 Parts List Drawings and Replacement Service Parts FRU 2037103 010 CARESCAPE V100 Main Board NOTE 1 Each main board comes with all parameters installed For monitors that do not include specific options Printer SpO Temperature these options must be turned off while the monitor is in configuration mode NOTE 2 Each main board comes configured with the SuperSTAT NIBP algorithm If your monitor was originally configured with the Auscultatory or Classic NIBP Algorithm the algorithm must be changed while the monitor is in configuration mode M r FRU 2037103 012 CARESCAPE V100 Ul Board 6 14 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Service Parts FRU 2037103 013 CARESCAPE V100 SpO Nellcor FRU 2037103 023 CARESCAPE V100 SpO Masimo FRU 2037103 024 CARESCAPE V100 SpO Ohmeda NOTE 1 All 3 SpO boards shown Kit includes only one NOTE 2 Nellcor hardware shown Kit includes matching hardware 203710
47. SpO adapter into the SpO gt connector on the front of the unit 3 Activate the Leakage Tester verify and record the temp circuit leakage current Temp Circuit Leakage Test 1 Setup an IEC 60601 1 approved leakage tester to apply 240 VAC to the isolated temperature circuit 2 Plugtemp probe adapter into the temp jack 3 Activate the Leakage Tester verify and record the temp circuit leakage current 2037106 001 B CARESCAPE V100 Vital Signs Monitor 4 17 Maintenance Test Results Form Test Results Form Description Min Max Actual Pass Fail N A LEAKAGE Pneumatic Leakage Result mmHg 0 6 PRESSURE TRANSDUCER VERIFICATION Pressure reading at 200mmHg top display Systolic 197 203 Pressure reading at 200mmHg bottom display 197 203 Diastolic Pressure reading at 150mmHg top display Systolic 147 153 Pressure reading at 150mmHg bottom display 147 153 Diastolic Pressure reading at 100mmHg top display Systolic 97 103 Pressure reading at 100mmHg bottom display 97 103 Diastolic Pressure reading at 50mmHag top display Systolic 47 53 Pressure reading at 50mmHag bottom display Diastolic 47 53 OVERPRESSURE VERIFICATION Overpressure threshold Adult mmHg 305 325 Overpressure threshold Neonate mmHg 150 165 BUTTONS NIBP Determination Initiated E80 displayed on SYSTOLIC display Audible alarm can be silenced Silenced LEDs flas
48. VIN3IUO Q31VALSNIII NI O311VLSNI 38 LSAW E INVINOdWI LON SI NOIIVIN3IBNO 2 1331 83MO Ol 1H9IY_Y3MO1 nous ONILYVLS S OTB NI 9 W N 819 0 OL 3NOYOL 801101 SY SMIONIT OL oy 0 ONIS ONIGNL nd SMO 1104 SY SHI9N31 OL i 8 GNIs ONIGNI 102 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 26 Parts List Drawings and Replacement 6 27 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement U N LET eM Ll eae ja YI P A e EA o o uu gt 3 3 2o 3 ow a a a xz ox w w w x P 2 2 zz 2 a a 2 6 lt lt x Zo o o o P z v lt lt gt w o o P lt Zo p x 3 z5 x w 23 I P lt gt za lt a 3 3 m v P x a gt o x a o 5 o a e z a 5 6 28 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Assembly Disassembly of FRUs Assembly Disassembly of FRUs Monitor Disassembly Procedure The following procedure is sequential i e you must remove the battery and rear case to remove the printer etc CAUTION Internal electronic components are susceptible to damage by electrostatic discharge To avoid damage when disassembling the monitor observe the standard precautions and procedures for handling static sensitive components Battery 1 Remove 4 screws securing
49. ages NOTES m Only transducer calibration pages are available until calibration is valid m Calibration and other service mode setting changes will not be retained unless the Save Settings operation is executed on the final Service Mode options page CARESCAPE V100 Vital Signs Monitor 2037106 001 B Installation Configuring Your V100 Monitor After all options pages have been displayed the display will return to the 1 service mode page initial calibration page To save service mode settings the Service Mode option pages are as follows Displayed on Monitor Function O in min window Refer to calibration section for functions 1 in min window Refer to calibration section for functions 2 in min window Refer to calibration section for functions 3 in min window NIBP Algorithm Type loaded Displayed in MAP Cuff display window 1 DINAMAP Classic NIBP 2 DINAMAP Auscultatory NIBP 3 DINAMAP SuperSTAT NIBP Warning Changing setting effects NIBP performance 4 in min window SpO gt Type loaded Displayed in SpO2 display window 0 No SpO 1 Nellcor 2 Masimo 3 Ohmeda Warning Incorrect setting will cause fatal 930 alarm during operation 5 in min window Temperature loaded Displayed in Temperature display window 0 No Temp 1 Turbo Temp 2037106 001 B CARESCAPE V100 Vital Signs Monito
50. al or hospital environment IEC 61000 4 4 1 kV for input output 1 kV for input lines output lines Surge 1 kV differential mode 1 kV differential Mains power should be that of a typical IEC 61000 4 5 mode commercial or hospital environment 2 kV common mode 2 kV common mode 596 U gt 95 dip in Uy 596 U gt 95 dip in for 0 5 cycles U for 0 5 cycles Voltage dips 4096 U gt 60 dip in Uy 4096 U 6096 dip Mains power should be that of a typical short for 5 cycles in Us for 5 cycles commercial or hospital environment If the interruptions user of the equipment requires continued and voltage lt 70 U gt 30 dip in U lt 70 U gt 30 dip operation during power mains interruptions variations on power supply input lines IEC 61000 4 11 for 25 cycles 596 U gt 95 dip in Uy for5s in U for 25 cycles 596 U 9596 dip in Uy for 5s it is recommended that the equipment be powered from an uninterruptible power supply or a battery Power Frequency 50 60 Hz Magnetic Field 3 A m 3 A m Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment IEC 61000 4 8 NOTE U is the AC mains voltage prior to application of the test level C 4 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Electromagnetic Compatibility EMC Electromagnetic Compatibility EMC CARESCA
51. applicable accessories with which GE Medical Systems claims EMC compliance NOTE Any supplied accessories that do not affect EMC compliance are not included Part No Description fiie Temperature Cables and Probes 2008774 001 Turbo Temp Oral Probe White cord Blue 3 0m 10 ft 2008775 001 Turbojets Rectal Probe White cord Red 3 6 m 12 ft Oximetry Cables and Sensors 70124033 Nellcor Multisite Sensor D YS Reusable Not Specified 70124021 Nellcor DuraSensor Reusable Finger Probe DS 100A 10m 33ft 2021406 001 Cable Assy SpO Nellcor OxiMax Smart 30m 10 ft 2025350 001 Cable Assy SpO Nellcor OxiMax Coro Version EF keying 3 0 m 10 ft 2021406 002 Cable Assy SpO Nellcor OxiMax Smart 1 2M A ft 407705 005 SpO Sensor Max R Adhesive Nasal 24 box Not Specified 70124026 SpO Sensor Max I Infant Adhesive Sensor 24 box Not Specified 70124032 SpO gt Sensor Max N Neonate Foot Adhesive Sensor 24 box Not Specified 70124022 SpO Sensor Max P Pediatric Finger Adhesive Sensor 24 box Not Specified 70124027 SpO gt Sensor Max A Adult Finger Adhesive Sensor 24 box Not Specified 2028117 001 SpO gt Sensor Max AL Adult Long Finger Adhesive Sensor 24 box Not Specified 414248 001 OXIBAND OXI P I Pediatric Infant Sensor Not Specified 41428 002 OXIBAND OXI A N Adult Pediatric Sensor Not Specified 2017002 001 Masimo LNOP SpO cable assembly 3 6m 12ft 2017002 003
52. asive blood pressure obtained at the central aortic region CARESCAPE V100 Monitors With Auscultatory Reference DINAMAP Auscultatory Reference Technology In these monitors the reference blood pressure is the auscultatory method for adult and pediatric populations For neonatal populations the reference is the invasive blood pressure obtained at the central aortic region NOTE For neonatal determinations the SuperSTAT algorithm is always used Temperature The V100 Monitor uses Alaris Turbo Temp technology to measure patient temperature The Turbo Temp probe contains a heating element that preheats the probe to reduce determination time The heating function is controlled by the Main Board The Turbo Temp probe also contains a thermistor that indicates the temperature When the probe is attached to the temperature connector and patient the signal generated by the thermistor is routed to the Main Board The Main Board converts the thermistor signal along with status information i e ORAL or RECTAL probe indicators to a DIGITAL signal The Main Board then processes the DIGITAL signal and displays the patient temperature on the UI Board and printer in Celsius or Fahrenheit Host Communication Port The Host Comm Port is used to interface the V100 Monitor with other electronic devices a central nurse s station or remote alarm device Signals can be sent to the V100 Monitor to initiate blood pressure determinations and other functions
53. atory Specific technologies are available in select markets All user interface options instructions for use and alarms will be the same for all technologies The NIBP parameter is included in all models Blood pressure is monitored noninvasively in the V100 Monitor by oscillometric method NOTE For neonatal populations the reference is always the intra arterial pressure monitoring method When the cuff and hose are attached to the V100 Monitor and a Non Invasive Blood Pressure NIBP determination is initiated the pump inflates the cuff Pressure transducers PT1 and PT2 monitor pressure information The pneumatic manifold has one valve which is used to deflate the cuff Valve control is through the Main Board Once determinations are made for the systolic NIBP and diastolic NIBP the Main Board calculates the pulse rate Mean Arterial Pressure MAP The results are then displayed on the UI Board and sent to the printer if the user presses the Print button The Pneumatics are controlled by the NIBP processor The NIBP processor monitors pressure information from PT2 If an over inflation condition occurs the OVERPRESSURE signal is routed to the Pneumatics to release the air pressure The Main Board also generates an alarm condition with the speaker sounding and error code message on the UI Board 2037106 001 B CARESCAPE V100 Vital Signs Monitor 2 9 Equipment Overview DINAMAP SuperSTAT Algorithm DINAMAP SuperSTAT Algorith
54. chments the temperature probe SpO gt sensor and cuff Interface with a central station or other device is accomplished through the host communication port on the back of the V100 Monitor NOTES m Priorto each use inspect the power supply cord to ensure proper connection and condition m Be sure to unplug the Monitor before transport 2 8 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Equipment Overview Overall Principles of Operation SpO The SpO probe has a built in sensor When the SpO sensor is attached to the SpO connector and patient the probe senses both heart rate and oxygen saturation The analog signals are routed to the SpO PWA Ohmeda Nellcor or Masimo The analog signals are analyzed on the SpO PWA The results are digitized and sent to the Main Board via opto couplers The couplers provide patient isolation as well as serial data interface The Main Board temporarily stores the data and routes it to the UI Board for display and or printer A reset signal to the SpO PWA is also provided so that power up sequencing is correct If the SpO gt circuit quits communicating to the Main Board the Main Board will attempt to reset the SpO PWA Cuff Blood Pressure NIBP and Pulse The NIBP parameter in the V100 Monitor is available with three types of DINAMAP NIBP technologies two calibrated to intra arterial pressure Classic and SuperSTAT and one calibrated to the auscultatory method Auscult
55. communicate when the software systems are operating properly When either system stops processing or detects an error it stops communicating with the other Either system upon detecting a failure can assert a safe state herein called FAILSAFE of the hardware Upon entering a FAILSAFE condition the Main Board will perform the following tasks Parameter monitoring disabled Alarm tone sounding from speaker Pneumatic FAILSAFE deflate the cuff pump off Normal communications interface disabled Remote alarm is in alarm state Hard keys except ON OFF key inactive The ON OFF key can reset the Monitor and end the FAILSAFE condition The FAILSAFE condition will terminate automatically after 5 minutes to preserve battery power All regulated DC power isolated and non isolated is generated on the Main Board from Battery supply The external DC input is used to charge the battery via charging circuitry on the Main Board User Interface UI Board PWA The UI Board is used as a message center It displays patient vital signs alarms status monitor set up limit violation NIBP cycle and the time the data was received The primary processor on the Main Board controls the UI Board When the primary processor reads the parameter signals it decodes the signals and routes the display information to the UI Board The UI assembly also provides hardkey switches for the V100 Main Board The primary processor asserts a HIGH on the 16 outputs of the
56. component or assembly could jeopardize the safe and effective operation of the monitor The following table offers details of each of the corresponding bubble numbers that appear on the exploded engineering assembly drawing drawing is located after this table Photos of each FRU follows NOTE FRU numbers are subject to change Bubble Number Part Number Description 2 2037103 002 FRU CARESCAPE Plastic Kit No PRTR 3 2037103 003 FRU CARESCAPE Plastic Kit W PRTR 4 2037103 004 FRU CARESCAPE V100 TEMPERATURE KIT 5 2037103 005 FRU CARESCAPE V100 Printer Assembly 60 2037103 006 FRU CARESCAPE V100 BZL BP ONLY 7 2037103 007 FRU CARESCAPE V100 Inner chassis kit 8 2037103 008 FRU CARESCAPE V100 PRTR DOORX1 ROLLERS X5 10b 2037103 010 FRU CARESCAPE V100 Main Board 12 2037103 012 FRU CARESCAPE V100 UI Board 13 2037103 013 FRU CARESCAPE V100 SpO gt NELLCOR 152 2037103 015 FRU CARESCAPE V100 Pneumatic Kit 16 2037103 016 FRU CARESCAPE V100 BATTERY X1 BATT 16 633178CR BATTERY LEAD ACID 6 VOLT 3 0 AH 17 2037103 017 FRU CARESCAPE V100 Speaker 18 2037103 018 FRU CARESCAPE V100 Cable kit 19f 2037103 019 FRU CARESCAPE V100 Fascia Kit EN 6 8 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Service Parts Bubble Number Part Number Descripti
57. ction EN 55011 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class B EN 55011 Harmonic Emissions Class A The equipment is suitable for use in all establishments including IEC 61000 3 2 domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage Fluctuations Complies Flicker Emissions IEC 61000 3 3 2037106 001 B CARESCAPE V100 Vital Signs Monitor C 3 Electromagnetic Compatibility EMC Electromagnetic Compatibility EMC CARESCAPE V100 Monitor Guidance and Manufacturer s Declaration Electromagnetic Immunity The CARESCAPE V100 Monitor is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to assure that the V100 Monitor is used in such an environment Immunity Test EN 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge ESD IEC 61000 4 2 6 kV contact 8kVair 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical Fast 2 kV for power supply 2 kV for power Mains power should be that of a typical Transient Burst lines supply lines commerci
58. d to the maximum allowed for the selected patient type In any operating mode if a patient s systolic pressure exceeds the inflation pressure of the monitor the monitor will begin normal deflation sequence detect the absence of a systolic value stop deflation reinflate to a higher than initial inflation pressure and resume normal deflation sequence In manual mode if a previous valid systolic pressure is displayed and less than 2 minutes old and the new systolic pressure oscillations are compared with the previous valid determination and the monitor thinks that the systolic was not obtained the monitor will inflate the cuff to a pressure above the immediately preceding inflation Reference Used to Determine NIBP Accuracy To establish accuracy of an NIBP device manufacturers have used several different types of references The reference blood pressures may be obtained by invasive pressure monitoring at the central aortic region or at the radial sites The reference blood pressures may also be obtained by noninvasive methods like auscultatory method using cuff and stethoscope NOTE For neonatal mode the reference is always the intra arterial pressure monitoring method 2037106 001 B CARESCAPE V100 Vital Signs Monitor 2 13 Equipment Overview Functional Description CARESCAPE V100 Monitors With Intra Arterial Reference DINAMAP SuperSTAT and Classic Technology For these monitors the NIBP is referenced to the inv
59. e items carefully and check them against the checklists enclosed within the accessory boxes If an accessory is missing or if an item is in a nonworking condition contact GE Medical Systems Information Technologies Customer Service immediately It is recommended that all the packaging be retained in case the V100 Monitor must be returned for service in the future 2037106 001 B CARESCAPE V100 Vital Signs Monitor 2 3 Equipment Overview Basic Components Basic Components Buttons 10 Silence button mutes audible alarms Any other active alarm that can be acknowledged is also removed whenever this key is pressed When pressed the silence icon bell lights red to indicate that audible alarms have been silenced for 2 minutes Alarm silence can be cancelled by pressing the Silence button again Alarms button used to view or adjust parameter alarm limit settings buttons Plus Minus used when you are in the following modes limit menu cycle and history When you are in limit or menu setting pressing the button increases and decreases an adjustable setting When you are in cycle or history mode pressing the buttons displays the next or previous cycle selection or entry in the history list respectively When you reach the beginning or ending of a list a negative key click sounds Menu button accesses menu settings that can be adjusted INFLATE PRESSURE ADULT and NEONATE ALARM VOLUME and PU
60. e the Monitor for 12 hours This charge calibrates the battery charging circuitry with the charge status of the battery 3 6 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Installation Configuring Your V100 Monitor Configuring Your V100 Monitor Operating Modes The V100 Monitor can operate in one of four modes clinical configuration advanced configuration and service Clinical Mode Clinical mode is the Monitor s normal operating mode While this mode is active alarm limits and a few other commonly used settings are adjustable All parameters are available for monitoring in this mode Configuration Mode Configuration and advanced configuration modes display the software revision and allow you to configure defaults for some settings that are available in clinical mode as well as some less commonly used settings that are only adjustable in these modes A fatal error history is also available in the advanced configuration mode No parameters are operable in these modes therefore patient monitoring is suspended Configuration Mode Settings Monitor settings such as HIGH LOW alarm settings changed in the Clinical Mode will not be retained after the monitor is powered off To retain alarm and parameter settings the changes must be done in the configuration mode Date Time settings are also entered in the configuration mode To enter the configuration mode with the Monitor off press and hold the Menu button at the sam
61. e time as pressing and holding the On Off button for 3 seconds The Monitor enters the configuration mode For a few seconds immediately after power up in this mode the Systolic and Diastolic windows display the major and minor version codes The version codes are numbers that represent the letters of the English alphabet which are designated to the currently loaded version of the monitor firmware e g 1 indicates A 2 indicates B etc At the same time the NIBP Algorithm selected in the monitor is displayed in the min minutes display window as follows m AUSC if the monitor is configured with auscultatory NIBP Algorithm m STAT if the monitor is configured with DINAMAP SuperSTAT Algorithm m CLAS if the monitor is configured with DINAMAP Classic Algorithm Display Window Major software revision Systolic Minor software revision Diastolic Type of NIBP technology min 2037106 001 B CARESCAPE V100 Vital Signs Monitor 3 1 Installation Configuring Your V100 Monitor These displays appear only during the first part of the power up sequence and are not selectable and cannot be changed After a moment this version information is cleared and the monitor displays the 1 page of configuration mode which simply displays CFG in the Systolic window Pressing the Menu button cycles through all the configuration option pages After all options pages have been displayed the display returns to the 1 co
62. e to neonate NIBP limits or inflation pressure settings AUTO CYCLE indicator lights green to indicate auto mode is the chosen NIBP mode flashes to indicate you are making a change to the auto mode Min window displays the NIBP mode if manual or Stat as well as the cycle time when taking auto NIBP determinations HISTORY indicator flashes to indicate you are in history mode BATTERY OK indicator lights green to indicate the monitor is operating on battery power and that the battery is sufficiently charged BATTERY LOW indicator lights amber to indicate low charge for the battery 45 min or less when solid 5 min or less when flashing CHARGING indicator lights green to indicate presence of external power source and battery charging Temperature window lights 4 digit red LED to indicate measured temperature 2 6 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Equipment Overview Product Compliance Product Compliance The CARESCAPE V100 Monitor is classified in the following categories for compliance with IEC 60601 1 Internally powered or Class II when powered from external supply Transportable For continuous operation Not suitable for use in the presence of flammable anesthetics Not for use in the presence of an oxygen enriched atmosphere oxygen tent Type BF applied parts IPX1 degree of protection against ingress of water Sterilization Disinfection see Appendix C Maintenance Software is devel
63. enance Parameter Level Functional Testing Pneumatic Leakage Testing NOTE To enter Service Mode press and hold the Cycle button while pressing Ur E We INS E 6 7 8 9 the On Off button Turn unit on and enter Service Mode Press Cycle button and 1 should appear in the min window Close the valve on the inflation bulb Using the inflation bulb inflate the system to 210 mmHg Allow the system to stabilize for 5 seconds it is normal to see some decrease in pressure at this point Start the stopwatch and record the pressure value After 60 seconds record the pressure value The leakage rate is the difference between the first and second readings Record and verify the leakage rate 10 Turn the V100 Monitor off Pressure Transducer Verification NOTE To enter Service Mode press and hold the Cycle button while pressing 10 11 12 13 14 15 16 the On Off button Turn unit on and enter Service Mode The min window should display 0 Open the valve on the inflation bulb and remove all pressure from the system manometer reads zero Press Cycle button and 1 should appear in the min window Use the inflation bulb to inflate the cuff hose and pressure indicator setup to 200 mmHg Record and verify the pressure reading that appears in the Systolic window Record and verify the pressure reading that appears in the Diastolic window Use the valve on the bulb to reduce pressure to 150 mmHg Rec
64. ental All loaners provided to customers must be returned within the specified time stated on the loaner agreement or a rental fee will be incurred Repair parts can be ordered from GE Medical Systems Information Technologies Via phone 1 800 558 7044 or Via FAX 1 800 421 6841 Exchange replacement assemblies such as Circuit Board Assemblies also are available ask the Customer Support representative for details Please allow one working day for confirmation of your order All orders must include the following information m Facility s complete name address and phone number m FAX number m Your purchase order number m Your GE Medical Systems Information Technologies account number Disposal of Product Waste As you use the V100 Monitor you will accumulate solid wastes that require proper disposal or recycling These include batteries patient applied parts and packaging material Batteries CAUTION Do not incinerate batteries The sealed rechargeable backup battery contains lead and can be recycled The rechargeable memory battery is of the Sealed Lead Acid form Discharge this battery prior to disposal Place the battery in packaging which electrically isolates its contents Do not puncture or place the battery in a trash compactor Do not incinerate the battery or expose it to fire or high temperatures Dispose in accordance with regional body controlled guideline 1 12 CARESCAPE V100 Vital Signs Monitor 203710
65. es and technical personnel who maintain troubleshoot or repair this equipment 2037106 001 B CARESCAPE V100 Vital Signs Monitor 1 9 Introduction Service Policy Intended Use General Use m The V100 Monitor is intended to monitor one patient at a time in a clinical setting m Federal law U S A restricts this device to sale by or on the order of a physician m To ensure patient safety use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies Parts and accessories used shall meet the requirements of EN60601 1 1 m Disposable devices are intended for single use only They should not be reused m Periodically and whenever the integrity of the monitor is in doubt test all functions Related Manuals Manual Title 2036991 001 CARESCAPE V100 Vital Signs Monitor Operator s Manual Service Policy Service Contracts Assistance The warranty for this product is enclosed with the product in the shipper carton All repairs on products under warranty must be performed or approved by Product Service personnel Unauthorized repairs will void the warranty Only qualified electronics service personnel should repair products not covered by warranty Extended warranties can be purchased on most products Contact your Sales Representative for details and pricing If the product fails to function properly or if assistance service or spare parts are required contact C
66. ff Child Dura Cuf assortment pack child 2 tube screw 2697 NIBP Cuff Dura Cuff Various Dura Cuf assortment pack various 2 tube screw 2699 SpO Ohmeda SpO gt Cable Assy 3M OxyTip Interconnect cable Ohmeda 3 m OXY ES3 SpO Sensor Finger Sensor with UN connector 1m OXY F UN SpO Sensor Wrap Sensor with UN connector 1m OXY W UN SpO Sensor Ear Sensor with UN connector 1 m OXY E UN SpO gt Sensor Sensitive Skin Sensor with UN connector 4m OXY SE 3 SpO gt Sensor Adult Pediatric Adhesive Sensor 25 box OXY AP 25 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 3 Parts List Drawings and Replacement Service Parts Part Part description Part number SpO gt Sensor Adult Pediatric Adhesive Sensor 10 box OXY AP 10 SpO gt Sensor AllFit Adhesive Sensor 0 9 m 10 box OXY AF 10 SpO gt Sensor Integrated finger sensor 4m OXY F4 GE SpO Sensor Integrated ear sensor OXY E4 GE SpO Sensor OxyTip Integrated Finger Care connector 2 m OXY F2 GE SpO Sensor OxyTip Integrated Ear Care connector 2 m OXY E2 GE SpO Accessory OxyTip wide replacement tape adhesive OXY RTW SpO Accessory Foam wrap replacement large weight range gt 3 kg OXY RWL SpO Accessory Foam wrap replacement medium weight range gt 3 kg OXY RWM SpO Accessory Foam wrap replacement small weight range 3 kg OXY RWS SpO Accessory OxyTip replacement tape A
67. ger Yes Reposition SpO sensor E20 SpO gt SpO gt sensor disconnected Yes Sensor disconnected E21 SpO SpO gt replace sensor Yes Replace SpO gt sensor E25 SpO gt SpO lost pulse Yes Reposition SpO sensor E61 Temp Temp probe broken No Replace temperature probe E63 Temp Temp disconnected Yes Check for correct probe E66 Temp Temperature probe too hot Ves Replace probe E80 NIBP Overpressure Yes Check for pinched or occluded internal tubing E82 NIBP Excess air in cuff Yes Wrong cuff type Failed valve on pneumatics assembly 5 6 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Troubleshooting Alarm Code Interpretation Error Code m Can be er Problem Source Definition Silenced Probable Source E83 NIBP NIBP pump timeout Yes Leak in cuff or o ring in hose Internal leak in tubing or pneumatic valve Pump not turning on E84 NIBP NIBP total timeout Yes Pneumatic assembly failure E85 NIBP NIBP level timeout Yes Cuff placement on patient Minor leak in cuff Pneumatic assembly failure E89 NIBP NIBP no determination Yes Cuff placement on patient Acknowledging an alarm by pressing the Silence button cancels the alarm 2037106 001 B CARESCAPE V100 Vital Signs Monitor 5 7 Troubleshooting Alarm Code Interpretation 5 8 CARESCAPE V100 Vital Signs Monitor 2037106 001 B O Parts List Drawings and Replacement For your notes 6 2 CARESCAPE V100 Vital Signs Monitor 2037106 001 B
68. gt Turn unit off Power on the Monitor During the power up self test verify all 7 segment LED display segments and all discrete LEDs illuminate Repeat power up cycle until all LEDs are checked Plug the power supply into the Monitor Verify that the CHARGING indicator is illuminated NOTE For best results it is important to be seated and not moving talking eating and or smoking etc while taking your blood pressure If you are uncertain as to the proper technique consult the operation manual Remove the calibration set up and attach an adult cuff and hose be sure to select the correct cuff size Press Start Stop button on monitor to begin a determination Record Systolic Diastolic map and heart rate from the Monitor display Wait 1 minute then press Cycle button to initiate a determination in Auto NIBP mode Record Systolic Diastolic map and heart rate from the Monitor display Wait 1 minute then press Cycle button until stat is displayed in the min window to initiate a determination in STAT mode Record Systolic Diastolic map and heart rate from the Monitor display Press Start Stop button end STAT mode CARESCAPE V100 Vital Signs Monitor 2037106 001 B Maintenance Parameter Level Functional Testing NIBP Overpressure Verification oN o Fr wm np Remove the cuff hose from the monitor restrict airflow from cuff hose port Press Start Stop to begin NIBP determination Verify E80 is di
69. h Overpressure alarm can be cleared Alarm button is functioning DISPLAY All 7 Segment LEDs Light Correct Color All Discrete LEDs Light Correct Color EXTERNAL DC DETECTION Charging indicator LED illuminated 4 18 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Maintenance Test Results Form Description Min Max Actual Pass Fail N A NIBP DETERMINATION Systolic reading mmHg Diastolic reading mmHg MAP reading mmHg Heart rate reading bpm Systolic reading mmHg Diastolic reading mmHg MAP reading mmHg Heart rate reading bpm Systolic reading mmHg Diastolic reading mmHg MAP reading mmHg Heart rate reading bpm NIBP OVERPRESSURE E80 displayed on SYSTOLIC display Pump will not start Overpressure alarm can be cleared TEMPERATURE TEST Temperature reading at 80 2 F 79 99 F 80 5 F Temperature reading at 98 6 F 98 4 F 98 8 F Temperature reading at 107 8 F 107 5 F 108 1 F SpO2 Pulse Value Displayed Saturation Value Displayed Signal Strength Bar displayed on SpO display Alarm is silenced error display remains Pulse Value Saturation Value Displayed Signal Strength Bar PRINTER TEST Printout is generated cleanly Temp Circuit Leakage Curren
70. h other changes press the Menu button CFG will appear in the Systolic window To change parameter settings press the Menu button and select the parameter function To change alarm settings press the Alarms button Inflation Pressure Default Setting Procedures 1 Enter the configuration mode with the Monitor off press and hold the Menu button at the same time as pressing and holding the On Off button for 3 seconds Use the buttons to increment or decrement the inflate pressure default setting To exit the configuration mode turn the unit off To continue with additional configuration settings press Menu 2037106 001 B CARESCAPE V100 Vital Signs Monitor 3 9 Installation Configuring Your V100 Monitor Alarm Default Settings Procedures 1 Enter the configuration mode with the Monitor off press and hold the Menu button at the same time as pressing and holding the On Off button for 3 seconds After the unit enters the configuration mode press Alarms At any point in the configuration mode menu Alarms default can be selected To set or change the default setting press the Alarms button to select alarm setting Use the buttons to increment or decrement the individual settings NOTE For the Alarms default setting to be saved you must advance the menu through the SpO settings To exit the configuration mode turn the unit off To continue with additional configuration settings press Menu
71. he BATTERY LOW alarm is not active the BATTERY OK indicator is backlit green When about 45 minutes of battery charge remains The low priority BATTERY LOW alarm is issued The BATTERY LOW indicator illuminates This alarm can be silenced by pressing the Silence button The BATTERY LOW alarm will re alarm every 10 minutes after it s been silenced If the alarm is not silenced the alarm is re issued every 8 seconds The monitor continues to operate normally When about 5 minutes of battery charge remains The low priority BATTERY LOW alarm escalates to a high priority BATTERY LOW alarm The BATTERY LOW indicator flashes Any NIBP determination in progress at the time of the alarm escalation is allowed to finish Any Stat mode cycle that was initiated before the alarm escalation is allowed to finish The user is not able to initiate any new NIBP determinations of any type any printouts NOTE At this time it is highly recommended to plug the monitor into external DC power When 5 minutes of battery charge expires After 5 minutes of high priority BATTERY LOW alarm the monitor enters a battery low shutdown No error code is displayed The BATTERY LOW indicator flashes The monitor alarms for 2 5 minutes then shuts down completely CAUTION You must plug the monitor into DC power before resuming monitoring 2037106 001 B CARESCAPE V100 Vital Signs Monitor 3 5
72. he V100 Monitor checking pressure calibration pneumatic leakage pneumatic system overpressure point temperature calibration 200 and 400 and verification of the SpO system 300 and 400 Perform the following maintenance procedures as required When the pneumatic integrity of any NIBP cuff and hose is in doubt replace the cuff and hose and discard the questionable accessories The monitor and its components should be carefully inspected prior to installation once every 12 months thereafter and each time the equipment is serviced Carefully inspect the equipment for physical damage to the case the display screen and the keypad Do not use the monitor if damage is determined Refer damaged equipment to qualified service personnel Inspect all external connections for loose connectors or frayed cables Have any damaged connectors or cables replaced by qualified service personnel Inspect the display face for marks scratches or other damage Physical damage to a flat panel display glass may pose an implosion hazard Have the flat panel display replaced by qualified service personnel if necessary Safety labels and inscription on the device are clearly legible 2037106 001 B CARESCAPE V100 Vital Signs Monitor 4 5 Maintenance Cleaning Cleaning Cleaning the Monitor CAUTIONS Never pour or spray water or any cleaning solution on the equipment or permit fluids to run behind switches into connectors
73. he monitor cuffs or accessories 4 4 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Maintenance Cleaning Cuffs Monitor Display To clean the display screen use a soft clean cloth dampened with a glass cleaner Never spray the glass cleaner directly onto the display and never use alcohol or petroleum based products General The cuff must be thoroughly cleaned with the specified detergent before reuse The additional use of household bleach as described below provides at least intermediate level disinfection Apply cuff hose plugs before cleaning The following cleansing procedure was repeated 20 times on DURA CUF Blood Pressure Cuffs and once on SOFT CUF Blood Pressure Cuffs without affecting the performance of the cuff While this procedure is adequate for cleaning disinfection it may not remove all stains Do not immerse hoses Do not immerse cuffs without prior application of cuff hose caps Materials Enzymatic detergent such as ENZOL enzymatic detergent US or Cidezyme enzymatic detergent UK Distilled water 10 solution of household bleach 5 2596 sodium hypochlorite in distilled water Soft cloths and soft bristled brushes Spray bottles Procedure Prepare the enzymatic detergent according to the manufacturer s instructions and the 1096 bleach solution in separate spray bottles Spray the detergent liberally on device If the material is dried on allow the cuff to sit for
74. hen using remote alarm the V100 Monitor should be considered the primary alarm source The secondary alarm is used for secondary purposes only 2037106 001 B CARESCAPE V100 Vital Signs Monitor 5 15 Installation Host Communications Connector Pin Function 1 Common 2 nverted TTL Transmit Data 3 nverted TTL Receive Data 4 5 volts 5 o connection 6 o connection 7 Common 8 Remote Alarm 9 o connection 10 o connection 11 RS232 Transmit Data TxD 12 o connection 13 RS232 Receive Data RxD 14 o connection 15 o connection 3 16 CARESCAPE V100 Vital Signs Monitor 2037106 001 B 4 Maintenance For your notes 4 2 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Maintenance Preventative Maintenance Preventative Maintenance General Integrity of Hoses and Cuffs Visual Inspection WARNING Failure on the part of all responsible individuals hospitals or institutions employing the use of this device to implement the recommended maintenance schedule may cause equipment failure and possible health hazards The manufacturer does not in any manner assume the responsibility for performing the recommended maintenance schedule unless an Equipment Maintenance Agreement exists The sole responsibility rests with the individuals hospitals or institutions utilizing the device Preventative maintenance tasks include cleaning t
75. i Sensor Neonatal Adult 20 Not Specified box 2027273 001 Masimo LNOP Disposable LNOP Blue Infant Thumb Toe Sensor Not Specified 20 box 2010463 001 Masimo LNOP Reusable Multisite Sensor LNOP YI Not Specified 2027274 001 Masimo LNOP Reusable Tip Clip Ear Sensor LKNOP TC I Not Specified 2009745 001 Masimo LNOP Reusable Finger Sensor Adult DC 195 Not Specified 2027259 001 Masimo LNCS DC IP Reusable Pediatric Sensor Not Specified 2027261 001 Masimo LNCS TC I TipClip Reusable Ear Sensor Not Specified 2027253 001 Masimo LNCS Adult Adhesive Sensor 20 box Not Specified 2027254 001 Masimo LNCS Pediatric Adhesive Sensor 20 box Not Specified 2027255 001 Masimo LNCS Infant Adhesive Sensor 20 box Not Specified 2027256 001 Masimo LNCS Neonatal Adhesive Sensor 20 box Not Specified 2027257 001 Masimo LNCS Neonatal PT Adhesive Sensor 20 box Not Specified OXY ES3 Ohmeda interconnect cable reusable 3 0 m 10 ft OXY F UN Ohmeda Finger sensor with UN connector 1 0m 3 3 ft CARESCAPE V100 Vital Signs Monitor 2037106 001 B Electromagnetic Compatibility EMC Electromagnetic Compatibility EMC CARESCAPE V100 Monitor Part No Description oe OXY W UN Wrap Sensor with UN connector 10m 3 3ft OXY E UN Ear Sensor with UN connector 10m 3 3 ft OXY E4 GE Integrated Ear Sensor 4 0 m 13 1 ft OXY F4 GE Integrated Finger Sensor 4 0 m 13 1 ft OXY SE 3 Sensitive Skin Sensor w
76. ic AUTO CYCLE Rf HIGH e Dl 5 1 7 m Li Low HISTORY 29 18 a PRESSURE Pulse Rate ES BATTERY OK 30 L ALARM VOLUME m 1 BATTERY Low 31 PULSE VOLUME j m CHARGING 32 21 SpO2 T Temperature E Low EEE T 33 15 Silence icon silences audible alarms for 2 minutes silence icon bell lights 16 Systolic window indicates measured systolic NIBP in mmHg 17 Diastolic window indicates measured diastolic NIBP in mmHg 18 INFLATE PRESSURE indicator flashes to indicate you are making a change to the inflation pressure Adjustable for adult ped and neonate patients 19 ALARM VOLUME indicator flashes to indicate you are making a change to the alarm volume 20 PULSE VOLUME indicator flashes to indicate you are making a change to the pulse volume 21 Pulse Rate window shows pulse rate in beats per minute 22 SpO gt pulse indicator flashing red LED bar indicates that pulses are being derived from SpO signals 23 SpO window indicates oxygen saturation in 96 24 MAP Cuff window indicates measured mean arterial pressure MAP in mmHg and shows cuff pressure during NIBP determination 2037106 001 B CARESCAPE V100 Vital Signs Monitor 2 5 Equipment Overview Front Panel 25 26 2T 28 29 30 31 32 33 ADULT indicator lights to indicate you are making a change to adult ped NIBP limits or inflation pressure settings NEONATE indicator lights to indicate you are making a chang
77. ic display window indicating that the monitor is in advanced configuration mode You can then press the Menu button to cycle through all the advanced configuration mode option pages After all options pages have been displayed the display will return to the 1 advanced configuration mode page displaying ACF You can use the and buttons to make changes to settings After making changes simply cycle the power to return to normal operation mode Changes are automatically be retained 2037106 001 B CARESCAPE V100 Vital Signs Monitor 3 11 Installation Configuring Your V100 Monitor Service Mode The advanced configuration mode option pages are as follows Displayed on Monitor Function ACF Advanced Configuration Mode announcement No settings are entered on this page ren Remote mode O Remote mode is disabled 1 Remote mode is enabled default Adr Host Comm unit address 32 This is the default value 126 max br Host Comm bit rate bits per sec 0 300 bps 1 600 bps 2 1200 bps 3 2400 bps 4 4800 bps 5 9600 bps default 6 19200 bps nod Host Comm mode O Host Comm Command mode default 1 1846 Compatibility mode 1846 mode requires user to also select 600 bps Service mode is entered by holding the Cycle button while powering on with the On Off button You can press the Cycle button to advance through the available service mode p
78. ied temperature probe to the corresponding connection A predictive temperature will begin once the probe is removed from its holster Place the probe in the holster after completion of the Temp cycle 2037106 001 B CARESCAPE V100 Vital Signs Monitor 4 9 Maintenance Parameter Level Functional Testing Ohmeda Nellcor and Masimo SpO Technologies The SpO gt sensor is an assembly consisting of two parts the sensor and the extender cable Connect the cables prior to attaching to the Monitor An SpO gt reading will be displayed within moments of attaching the sensor to either a simulator or to your finger Calibration Procedures and Tests NOTE All devices are tested and calibrated during manufacturing and are Annual Procedures certified for operation at installation To adequately test the safety and integrity of the V100 Monitor the following test equipment is recommended 12VDC power supply IEC 60601 1 approved leakage tester Digital manometer with range to 350 mmHg Stopwatch timer capable of measuring seconds Adult NIBP cuff Neonate NIBP cuff hose inflation bulb and associated tubing Calibration kit p n 320246 available through GE Medical Systems SpO cable for appropriate SpO type if SpO is installed TE 1811 Temperature Probe Simulator if TEMP is installed available from Cardinal Health Inc Printer paper if PRINTER is installed 3 diameter rigid cylinder mandrel SPO connector with a
79. ies used must meet the requirements of the applicable IEC EN 60601 series safety standards and or the system configuration must meet the requirements of the IEC 60601 1 1 medical electrical systems standard Periodically and whenever the integrity of the device is in doubt test all functions 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 m use of the accessory in the PATIENT VICINITY and m evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601 1 and or IEC 60601 1 1 harmonized national standard If the installation of the equipment in the USA will use 240V rather than 120V the source must be a center tapped 240V single phase circuit References to Persons Places and Institutions References to persons places and institutions used within this manual are solely intended to facilitate user comprehension of the V100 Monitor s use and functions Extreme care has been taken to use fictitious names and related information in the examples and illustrations provided herein Any similarity of this data to persons either living or dead and to either current or previously existing medical institutions should be regarded as coincidental 1 4 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Introducti
80. instructions necessary to operate the equipment safely in accordance with its function and intended use Ordering Manuals A paper copy of this manual will be provided upon request Contact your local GE representative and request the part number on the first page of the manual Safety Information The information presented in this section is important for the safety of both the patient and operator This chapter describes how the terms Danger Warning Caution Important and Note are used throughout the manual In addition standard equipment symbols are defined 2037106 001 B CARESCAPE V100 Vital Signs Monitor 1 3 Introduction Safety Information Responsibility of the Manufacturer General GE is responsible for the effects on safety reliability and performance only if m assembly operations extensions readjustments modifications or repairs are carried out by persons authorized by GE m the electrical installation of the relevant room complies with the requirements of appropriate regulations and m the monitor is used in accordance with the instructions of use This device is intended for use under the direct supervision of a licensed health care practitioner This device is not intended for home use Federal law restricts this device to be sold by or on the order of a physician Contact GE for information before connecting any devices to the equipment that are not recommended in this manual Parts and accessor
81. into the recorder or into any ventilation openings in the equipment Do not let fluid pool around connection pins Never immerse monitor or accessories in any liquid Do not attach the monitor or accessories to a patient until it is thoroughly dry Failure to follow these cleaning recommendations may melt distort or dull the finish of displays and cases blur lettering on labels embrittle cases and lead to cracks and breakage or cause equipment failures Use of non approved cleaning agents is not considered normal wear and repair or replacement of parts is not covered under warranty Monitor Exterior Disconnect the monitor from AC power before cleaning or disinfecting its surface The exterior surfaces of CARESCAPE Monitors may be cleaned with a dampened lint free cloth Wipe off all cleaning solutions with a clean dry cloth and let air dry for at least 15 minutes Use one of the following approved solutions m Mild soap diluted m Commercial diluted bleach solution or bleach wipe m Commercial diluted ammonia solution m 10 solution of household bleach 5 2596 sodium hypochlorite in distilled water Never use the following cleaning agents Abrasive cleaners or solvents of any kind Acetone Ketone Betadine Alcohol or petroleum based cleaning agents Any type of solution that contains ammonium chloride conductive solutions wax or wax compounds m Sodium salts NOTE Never autoclave or steam clean t
82. ith UN connector 4 0 m 13 1 ft OXI AF 10 ALLfit Adhesive Sensor 10 box 0 9M 3 ft OXV AP 25 Adult Pediatric Adhesive Sensor 25 box Not Specified OXV AP 10 Adult Pediatric Adhesive Sensor 10 box Not Specified Accessories 600028 AC cable Hospital Grade AHA 24m 8ft 2018859 001 Universal AC DC adapter Not Specified 320760 Isolated Level Converter ILC 1926 Not Specified 354550CR Isolated Level Converter ILC 1931 Not Specified 2024500 001 Patient ID IR Cable Not Specified 487208CR DINAMAP Compact Remote Alarm Cable Not Specified 418497 002 Cable Assy Telemetry Interface Dinalink 1 8m 6 ft 683235 Cable Assy Dinamap PLUS Compact to V link transmitter EX 165cm 2037106 001 B CARESCAPE V100 Vital Signs Monitor C 9 Electromagnetic Compatibility EMC Electromagnetic Compatibility EMC CARES CAPE V100 Monitor For your notes C 10 CARESCAPE V100 Vital Signs Monitor 2037106 001 B GE Medical Systems Information Technologies Inc 8200 West Tower Avenue Milwaukee WI 53223 USA Tel 1414355 5000 1800 558 5120 US only Fax 41414 355 3790 GE Medical Systems Information Technologies GmbH Munzinger Stra e 3 5 D 79111 Freiburg Germany Tel 497614543 0 Fax 49 76145 43 233 Asia Headquarters GE Medical Systems Information Technologies Asia GE China Co Ltd 24th Floor Shanghai MAXDO Center 8 Xing Yi Road Hong Qiao Development Zone Shanghai 200336 P R China Tel 86 21 5257 46
83. lay is 98 6 F 0 2 F Set the simulator to 107 8 F Record and verify the reading in the temp display is 107 8 F 0 2 F 11 Calibration is complete If the monitor does no pass the calibration verification then contact Technical Support SpO Perform only if equipped with SpO module 1 Connect the appropriate SpO probe and cable to the SpO connector Place the probe on your finger 2 Verify the unit displays a Pulse value Soturation value Signal Strength Bar Graph 3 Remove the sensor from your finger to generate a SpO SENSOR OFF FINGER alarm and to sound the speaker 4 Pressthe Silence button 5 Verify the sound has stopped and the SpO gt SENSOR OFF FINGER error is Cleared 6 Re apply the SpO gt sensor to your finger 7 Verify the unit displays a Pulse Value Saturation value Signal Strength bar Graph Printer Output Test 1 Load Paper into the print mechanism 2 Press Print button 3 Verify the printer outputs a record and print quality is good 4 16 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Maintenance Parameter Level Functional Testing Safety Testing 1 Connect leakage tester to unit as shown above NOTE Connection to SpO connector shown switch red lead to temperature connector to test temperature circuit SpO gt Circuit Leakage Test 1 Setup an IEC 60601 1 approved leakage tester to apply 240 VAC to the isolated SpO circuit 2 Plug
84. ll leads shorted Temperature connector with all leads shorted DC input connector with both wires shorted CAUTION Calibration equipment should always be kept dry and free of particulate matter Moisture or foreign substances introduced to the pneumatic system will likely cause damage to the Monitor and or the accessories Perform the following test procedures every 12 months or whenever the accuracy of any reading is in doubt CARESCAPE V100 Vital Signs Monitor 2037106 001 B Maintenance Parameter Level Functional Testing Parameter Test Procedures Complete the Test Record at the end of this section as tests are performed NOTES m This test is written so that a knowledgeable technician who is familiar with the V100 Monitor and the test equipment and will be able to follow the test procedure m To enter Service Mode press and hold Cycle button while pressing the On Off button Setup 1 Connect manometer to unit as shown 2 Tan inflation bulb into the pneumatic setup 3 Consult the following diagram for pneumatic setup guidelines 2 NIST CALIBRATED DIGITAL MANOMETER INFLATION MANDREL D 33 mas LOW ADULT le Diastolic AUTO CYCLE Bo INFLATE PRESSURE Pulse Rate E BATTERY ALARM VOLUME 3 i BATTERY Low bem PULSEVOLUME fa leer carana SpO gt CALIBRATION KIT 12 AIR HOSE 2037106 001 B CARESCAPE V100 Vital Signs Monitor 4 11 Maint
85. llFit Sensor Bears 100 box OXY RTB SpO Accessory OxyTip replacement tape AllFit Sensor Blue 100 box OXY RT SpO Accessory Infant Foam Sandal use with OxyTip Sensitive Skin sensor OXY SND 3 box SpO Nellcor SpO gt Cable Assy 3M Cable Assy SpO Nellcor OxiMax 3 m Smart 2021406 001 SpO gt Cable Assy 3M Cable Assy SpO Nellcor OxiMax 1 2 m Smart 2021406 002 SpO Sensor Max A Adult Finger Adhesive Sensor 24 box 70124027 SpO Sensor Max AL Adult Long Finger Adhesive Sensor 24 box 2028117 001 SpO gt Sensor Max P Pediatric Finger Adhesive Sensor 24 box 70124022 SpO gt Sensor Max N Neonate Foot Adhesive Sensor 24 box 70124032 SpO gt Sensor Max I Infant Adhesive Sensor 24 box 70124026 SpO Sensor Max R Adhesive Nasal 24 box 407705 005 SpO gt Sensor OXIBAND OXI P I Pediatric Infant Sensor 414248 001 SpO gt Sensor OXIBAND OxI A N Adult Neonate Sensor 414248 002 SpO Sensor OXIBAND OXI A N Adult Neonate Sensor 70124035 EMEA SpO Sensor Nellcor Multisite Sensor D YS Reusable 70124033 SpO Sensor Nellcor DuraSensor DS 100A 70124021 SpO Sensor Nellcor DuraSensor DS 100A 407705 006 US 6 4 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Service Parts Part description Part number SpO Acce
86. m The oscillometric method of determining NIBP is accomplished by a sensitive transducer which measures cuff pressure and pressure oscillations within the cuff For the first determination taken on a patient the algorithm stores the pattern of the patient s oscillation size as a function of the pressure steps For subsequent manual auto or Stat determinations taken within 2 minutes of a previous determination of the same patient as few as four pressure steps may be necessary to complete the determination process In auto mode the data is stored for up to 16 minutes When employing fewer pressure steps the system uses the stored information from the previous blood pressure determination to decide the best pressure steps to take The algorithm measures the consistency of pulse size to tell if the oscillations taken at a step are good and if more steps are needed The first determination settles at an initial target pressure of 135 mmHg adult mode and 100 mmHg neonate mode depending on initial target pressure preset To allow for rapid settling of cuff pressure the monitor will momentarily inflate to a higher pressure then immediately deflate to the target pressure After inflating the cuff the NIBP parameter begins to deflate The oscillations versus cuff pressure are measured to determine the mean pressure and calculate the systolic and diastolic pressures During an NIBP determination the parameter deflates the cuff one step each time i
87. me date will NOT be lost when the battery is 4 8 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Maintenance Parameter Level Functional Testing disconnected while the DC charger is attached i e monitor is plugged in Configured settings and time date WILL be lost if the battery is disconnected while the DC charger is not attached i e monitor is not plugged in 8 Resetthe date time and applicable user settings CAUTION Do not touch either the pin of the DC input connector or the terminals within the battery compartment and the patient at the same time Replacement batteries can be obtained from GE Medical Systems Information Technologies Fuses The monitor contains three fuses The fuses are mounted within the monitor The fuses protect the low voltage DC input the battery and the remote alarm output The 5 V output on the host port connector is regulated by internal supply Fuses are not replaceable Parameter Level Functional Testing After the initial configuration is complete perform functional testing of each of the parameters using the accessories supplied with the V100 Monitor Refer to the operation manual for more detailed parameter specific instructions NIBP Perform a blood pressure by connecting the supplied hose and cuff together then attaching to the front of the V100 Monitor Press the Start button on the front to begin the NIBP cycle Temperature Connect the suppl
88. n If low level disinfection is required use a 1 10 bleach solution Do not use undiluted bleach 596 5 2596 sodium chlorite or any cleaning solution other than those recommended here because permanent damage to the sensor could occur Do not sterilize the sensor by irradiation steam or ethylene oxide If disposable sensors or their packaging are damaged they must be disposed of as advised in this appendix To clean or disinfect the sensor 1 Saturatea clean dry gauze pad with the cleaning solution Wipe all surfaces of the sensor and cable with this gauze pad 2 Saturate another clean dry gauze pad with sterile or distilled water Wipe all surfaces of the sensor and cable with this gauze pad 3 Dry the sensor and cable by wiping all surfaces with a clean dry gauze pad Long Term Storage If it becomes necessary to store the Monitor for an extended period of time remove all attached accessories Attach the original packing inserts and place the Monitor into the original shipping container Battery life is significantly reduced if the battery is left in a discharged state For long term storage fully charge the battery then remove the battery from the unit and periodically charge the battery For more information refer to the Storage and Battery Care section below Long term storage at high temperatures can lead to deterioration of seals and separators and should be avoided 4 6 CARESCAPE V100 Vital Signs Monitor
89. n about wavelength range can be especially useful to clinicians A 8 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Technical Specifications and Default Settings Specifications Masimo Sp0 Masimo SpO Specifications Measurement range SpO 1 to 10096 Pulse rate 25 to 240 bpm Perfusion range 0 02 to 2096 Accuracy and motion tolerance Saturation Without motion adult pediatric 70 to 100 2 digits Without motion neonate 70 to 100 3 digits With motion adult pediatric neo t 70 to 100 3 digits Low perfusiont 70 to 100 2 digits 0 to 69 unspecified Pulse rate Without motion 25 to 240 bpm 3 digits With motion normal physiologic range 25 to 240 bpm 5 digits The Masimo SET SpO gt parameter with LNOP Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70 100 SpO against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population The Masimo SET SpO parameter with LNOP Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a nonrepetitive motion between 1 to 5 Hz at an amplitude of 2
90. ndow 9 Press and hold Menu button until monitor beeps and the number in the MAP Cuff window decrements by 1 which acknowledges that data was saved 10 Turn the Monitor off Overpressure Verification NOTE To enter service mode press and hold Cycle button while pressing the On Off button 1 Wait a few seconds after entering service mode Press Cycle button so that the min window changes from O to 1 2 Use the inflation bulb to inflate close to 300 mmHg Slowly inflate 1 to 2 mmHg sec until valve opens and pressure is released 3 Record and verify pressure at which valve opens 4 Press Cycle button and 2 should appear in the min window 5 Use the inflation bulb to inflate close to 150 mmHg Slowly inflate 1 to 2 mmHg sec until valve opens and pressure is released 6 Record and verify pressure at which valve opens 7 Turn unit off 2037106 001 B CARESCAPE V100 Vital Signs Monitor 4 13 Maintenance Parameter Level Functional Testing Button Testing LED Tests External DC Verification NIBP Determination OO cem S SLS SES Disconnect the cuff hose assembly and power on the unit Press Inflate Stop button Verify a NIBP determination has been initiated Block pump port and verify E80 alarm Verify flashing red indicator of Silence button Press Silence button verify alarm has been removed Press Alarm button several times verify unit cycles through all alarm settings li e SYS DIA SpO
91. netic Compatibility Requirements and Tests and CISPR 11 Group 1 Class B for radiated and conducted emissions Printer Printer Specifications Printer type Thermal dot array Resolution 384 dots inch horizontal Paper type The paper roll used by the printer must be compatible with GE PN 770137 Languages printed English German French Italian Spanish Portuguese Brazil and Portugal Hungarian Polish Czech Finnish Swedish Danish Dutch Norwegian and Slovak Languages not printed text printed in English only Russian Greek Korean and Japanese NIBP NIBP Specifications Cuff pressure range Normal operating range 0 to 290 mmHg adult ped 0 to 145 mmHg neonate Blood pressure accuracy Classic and Auscultatory Meets ANSI AAMI standard SP 10 1992 mean error lt 5 mmHg standard deviation lt 8 mmHg Blood pressure accuracy SuperSTAT Meets ANSI AAMI standard SP 10 2002 mean error lt 5 mmHg standard deviation lt 8 mmHg Maximum determination 120 s adult ped 85 s neonate Overpressure cutoff 300 to 330 mmHg ladult ped 150 to 165 mmHg neonate A 4 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Technical Specifications and Default Settings Specifications NIBP Specifications BP range Classic and Auscultatory Systolic 30 to 245 mmHg ladult ped 40 to 140 mmHg neonate MAP 15 t
92. nfiguration mode page displaying CFG You can use the and buttons to make changes to settings After making changes simply cycle the power to return to normal operation clinical mode Changes are automatically retained The Menu selections appear in the following order Refer the each manual section for settings options NOTE Menu selections for SpO settings are different depending upon the SpO technology your monitor contains Pulse Rate Setting Window LED Display Window Comment Display Inflate pressure Systolic XXX numeric XXX numeric ADULT indicator illuminated adult ped INFLATE PRESSURE indicator flashing Inflate pressure Systolic XXX numeric XXX numeric NEONATE indicator illuminated neonate INFLATE PRESSURE indicator flashing Line frequency mode SpO gt 50 or 60 LE AC line frequency Ohmeda TruSignal only u SpO gt mode SpO 1or2 find User selects the averaging Nellcor only technique 1 Normal Response 2 Fast Response SpO gt sat SpO 0 10 25 50 100 GAL User selects the SMART Sat Nellcor only tolerance level SpO mode SpO 4 6 8 10 12 14 16 find User selects the number of Masimo only seconds over which data is averaged 4 to 16 SpO sat SpO gt Oor1 SAR Fast Sat Mode 0 Off 1 On Masimo only SpO gt sensitivity SpO gt 1 2 3 SEn 1 Low Perfusion Maximized Masimo only 2 Low Perfusion Default 3 for engaging Adapti
93. nit never calibrated Mains PWA issue 975 System Could not save calibration data No Mains PWA issue 976 System Power supply voltage has peaked No External power brick issue above 18 Volts incorrect power supply 979 System Unknown power processor mode No Mains PWA issue received on power up 2037106 001 B CARESCAPE V100 Vital Signs Monitor 5 5 Troubleshooting Alarm Code Interpretation Error Code m Can be Sr Problem Source Definition Silenced Probable Source 980 System Heap memory exhausted No Mains PWA issue 984 System Unused vector called No Return unit for evaluation 985 System RTK 400hz timer re entry No Return unit for evaluation 986 System RTK 50hz timer re entry No Mains PWA issue 989 System RTK overrun No Mains PWA issue 994 System Stack overflow No Mains PWA issue 999 System Background task stalled No Mains PWA issue E10 Printer Printer no paper Yes No paper in printer Printer problem E11 Printer Printer too hot Yes Printer problem E13 Battery Battery low Ves Battery too low to operate the unit Charge battery External DC source failed Replace battery BATTERY Battery Battery is running low Ves Plug monitor in to recharge LOW E00 Battery Memory lost Yes Usually noted after changing batteries User settings and date time revert to default settings SpO gt SpO gt Sensor off fin
94. nue with additional configuration settings press the Menu button Procedure for units with Masimo Technology 1 With the monitor off press and hold the Menu button at the same time as pressing the On Off button until the display test completes 2 Press the Menu button until nOd averaging time appears in the Pulse Rate window Use the buttons to select the option Press the Menu button once SAt FastSAT appears in the Pulse Rate window Use the buttons to select the option ON UD e oen Press the Menu button once SEn sensitivity mode appears in the Pulse Rate window gt Use the buttons to select the option 8 Toexit the configuration mode turn the unit off To continue with additional configuration settings press the Menu button Advanced Configuration Mode Advanced Configuration mode is entered by holding the Menu button and the button simultaneously while powering on with the On Off button For a couple of seconds immediately after power up in this mode the Systolic and Diastolic display windows will display the major and minor version codes The version codes are numbers that represent the letters of the English alphabet which are designated to the currently loaded version of the monitor firmware e g 1 indicates A 2 indicates B etc After a moment this version information is cleared and the monitor displays the 1 page of configuration mode which simply displays ACF in the Systol
95. o 215 mmHg adult ped 30 to 115 mmHg neonate Diastolic 10 to 195 mmHg adult ped 20 to 100 mmHg neonate BP range SuperSTAT Systolic 30 to 290 mmHg ladult ped 30 to 140 mmHg neonate MAP 20 to 260 mmHg adult ped 20 to 125 mmHg neonate Diastolic 10 to 220 mmHg adult ped 10 to 110 mmHg neonate Pulse rate range Classic and Auscultatory 30 to 200 beats min adult ped 30 to 220 beats min neonate Pulse rate range SuperSTAT 30 to 240 beats min adult ped 30 to 240 beats min neonate Pulse rate accuracy 3 5 or 3 bpm GE CRITIKON BP cuffs are used NOTE All CARESCAPE V100 Monitor regulatory and accuracy studies have been performed using GE CRITIKON BP cuffs Use only GE CRITIKON BP cuffs The size shape and bladder characteristics can affect the performance of the instrument Inaccurate readings may occur unless Ohmeda SpO Ohmeda SpO Specifications Measurement range SpO 1 to 100 Pulse rate 30 to 250 bpm Perfusion range 0 05 to 2096 Accuracy Saturation Adult 70 to 100 2 digits whichever is greater without motion Neonate 70 to 100 3 digits without motion Adult Neonate 70 to 100 3 digits during clinical motion 2037106 001 B CARESCAPE V100 Vital Signs Monitor A 5 Technical Specifications and Default Settings Specifications Ohmeda SpO Specifica
96. on 22 2037103 022 FRU CARESCAPE V100 ALL HARDWARE KIT 23 2037103 023 FRU CARESCAPE V100 SpO MASIMO 24 2037103 024 FRU CARESCAPE V100 SpO OHMEDA 25 2037103 025 FRU CARESCAPE V100 Fascia Kit GER 26 NA NA 27 2037103 027 FRU CARESCAPE V100 Fascia Kit CZ 28 2037103 028 FRU CARESCAPE V100 Fascia Kit DA 29 2037103 029 FRU CARESCAPE V100 Fascia Kit DU 30 2037103 030 FRU CARESCAPE V100 Fascia Kit FIN 31 2037103 031 FRU CARESCAPE V100 Fascia Kit FRE 32 2037103 032 FRU CARESCAPE V100 Fascia Kit GR 33 2037103 033 FRU CARESCAPE V100 Fascia Kit HU 34 2037103 034 FRU CARESCAPE V100 Fascia Kit IT 35 2037103 035 FRU CARESCAPE V100 Fascia Kit JA 36 2037103 036 FRU CARESCAPE V100 Fascia Kit KOR 37 2037103 037 FRU CARESCAPE V100 Fascia Kit NO 38 2037103 038 FRU CARESCAPE V100 Fascia Kit PO 39 2037103 039 FRU CARESCAPE V100 Fascia Kit PORT 40 2037103 040 FRU CARESCAPE V100 Fascia Kit RU 41 2037103 041 FRU CARESCAPE V100 Fascia Kit SLO 42 2037103 042 FRU CARESCAPE V100 Fascia Kit SP 43 2037103 043 FRU CARESCAPE V100 Fascia Kit SW 449 2037103 044 FRU CARESCAPE V100 Keypad Kit 529 2037103 052 FRU CARESCAPE V100 BZL BP TEMP 530 2037103 053 FRU CARESCAPE V100 BZL BP SpO J 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 9 Parts List Drawings and Replacement Service Parts Bubble Number Part Number Description 549 2037103 054 FRU CARESCAPE V100 BZL BP amp SpO gt TEMP 568 20
97. on Safety Information Warnings Cautions and Notes The terms danger warning and caution are used throughout this manual to point out hazards and to designate a degree or level or seriousness Familiarize yourself with their definitions and significance Hazard is defined as a source of potential injury to a person WARNING indicates a potential hazard or unsafe practice which if not avoided could result in death or serious injury CAUTION indicates a potential hazard or unsafe practice which if not avoided could result in minor personal injury or product property damage NOTE provides application tips or other useful information to assure that you get the most from your equipment Product Specific Hazards WARNINGS Do not use the CARESCAPE V100 Vital Signs Monitor in the presence of magnetic resonance imaging MRI devices There have been reports of sensors causing patient burns when operating in an MRI environment Do not use the Monitor in the presence of flammable anesthetics The use of approved accessories will provide protection from burns during HF surgery To help prevent unintended current return paths with the use of high frequency HF surgical equipment ensure that the HF surgical neutral electrode is properly connected To avoid personal injury do not perform any servicing unless qualified to do so These Monitors should not be used on patients who are connected to cardiopulmonary bypass machine
98. on sequence 170 162 154 146 138 y 1 106 98 2 I A o il I a E a S 5 al O ier OSCILLATION N I 2 AMPLITUDE i al rc HL FETTE TIME NIBP determination sequence At each step the microprocessor stores cuff pressure the matched pulse amplitude and the time between successive pulses The stepped deflation and matched pulse detection continues until diastolic pressure is determined or total cuff pressure falls below 7 mmHg The monitor then deflates the cuff to zero detected pressure analyzes the stored data and updates the screen 2 12 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Equipment Overview DINAMAP Classic and Auscultatory Reference Algorithm Systolic Search The operating cycle is composed of four parts inflation time deflation time evaluation time and wait time Wait time which varies from mode to mode is affected by the cycle time auto mode or operator intervention manual model The figure shows the basic operating cycle INFLATION TIME WAIT TIME EVALUATION TIME DEFLATION TIME DETERMINATION TIME CYCLE TIME CUFF PRESSURE TIME NIBP operating cycle If systolic pressure is not found the NIBP parameter can search at cuff pressures higher than the initial target pressure The parameter will inflate the cuff above the initial target pressure to get more data in the systolic region The pressure is limite
99. oped in accordance with IEC 60601 1 4 This equipment is suitable for connection to public mains via power adaptors as defined in CISPR 11 m The SpO parameter complies to ISO 9919 2005 m Defibrillation protected When used with the recommended accessories the monitor is protected against the effects of defibrillator discharge If monitoring is disrupted by the defibrillation the monitor will recover CARESCAPE V100 Monitor Classified with respect to electric shock fire and mechanical and other specified hazards only S R in accordance with CAN CSA C22 2 No 60601 1 Also evaluated to IEC 60601 2 30 Medical Device Directive 93 42 Accessories without the CE mark are not guaranteed to meet the Essential Requirements 0459 of the Medical Device Directive C This product conforms with the essential requirements of the The CARESCAPE V100 Monitor is protected against vertically falling drops of water and conforms with the IEC 529 PX 1 standard at level of IPX1 No harmful effects will come of vertically falling drops of water making contact with the monitor 2037106 001 B CARESCAPE V100 Vital Signs Monitor 2 7 Equipment Overview Theory of Operation Theory of Operation Introduction This section provides overall theory of operation and functional description of the V100 Monitor Monitors are available with or without integrated printers as well as the following parameters and technologies m NIBP Pulse DINAM
100. ord and verify the pressure reading that appears in the Systolic window Record and verify the pressure reading that appears in the Diastolic window Use the valve on the bulb to reduce pressure to 100 mmHg Record and verify the pressure reading that appears in the Systolic window Record and verify the pressure reading that appears in the Diastolic window Use the valve on the bulb to reduce pressure to 50 mmHg Record and verify the pressure reading that appears in the Systolic window Record and verify the pressure reading that appears in the Diastolic window CARESCAPE V100 Vital Signs Monitor 2037106 001 B Maintenance Parameter Level Functional Testing Pressure Transducer Calibration Perform only if Pressure Transducer Verification is out of tolerance as specified in Test Results Table at the end of this section NOTE To enter service mode press and hold Cycle button while pressing the On Off button Turn the V100 Monitor on and enter Service Mode The min window should display 0 Open valve on bulb to open pressure system to atmosphere Verify the manometer reads zero Press Cycle button and 1 should appear in the min window oO m 75 wm EB Close valve on bulb and slowly inflate pressure to 200 mmHg using the manometer as reference 7 Press Menu button when pressure reads exactly 200 mmHg to set calibration value 8 Tosave the calibration setting press the Cycle button until 6 appears in the min wi
101. otion Finger 2 digits without motion LNOP NEO PT L 3 digits without motion LNOP Adtx 2 digits without motion LNOP Pdtx 2 digits without motion LNOP DCI 2 digits without motion LNOP DCIP 2 digits without motion LNOP Hi Fi Neo adult Foot 3 digits without motion Finger 2 digits without motion LNOP Hi Fi Infant Ped 2 digits LNOP Blue Infant Thumb Toe 3 digits for 80 100 without motion 4 digits for 60 80 without motion 3 3 digits for 70 100 without motion LNOP YI Multi Site Foot hand 3 digits without motion Finger toe 2 digits without motion LNOP DC 195 2 digits without motion LNOP TC I 3 5 digits without motion LNCS TCI 3 5 digits without motion LNCS DC I 2 digits without motion LNCS DC IP 2 digits without motion LNCS Adult Adtx 2 digits without motion LNCS Ped Pdtx 2 digits without motion LNCS Infant L 2 digits without motion LNCS Neo PT L 3 digits without motion Resolution Saturation 96 SpO 1 Pulse rate bpm 1 Low perfusion performance 0 02 Pulse amplitude and transmission gt 5 Saturation 96 SpO 2 digits Pulse rate 3 digits CARESCAPE V100 Vital Signs Monitor 2037106 001 B Technical Specifications and Default Settings Specifications Specifications Masimo sensor accuracy Interfering substances Carboxyhemoglobin may erroneously increase readings The level of increa
102. product for repair you must have a RMA number Contact GE Medical Systems Information Technologies Follow these recommended packing instructions m Remove all hoses cables sensors and power cords from the monitor before packing m Pack only the accessories you are requested to return place them in a separate bag and insert the bag and the product inside the shipping carton m Use the original shipping carton and packing materials if available If the original shipping carton is not available m Place the product in a plastic bag and tie or tape the bag to prevent loose particles or materials from entering openings such as hose ports m Use a sturdy corrugated container to ship the product tape securely to seal the container for shipping m Pack with 4 to 6 in of padding on all sides of the product Insurance is at the customer s discretion The shipper must initiate claims for damage to the product 2037106 001 B CARESCAPE V100 Vital Signs Monitor 1 11 Introduction Disposal of Product Waste Service No Charge Rental Repair Parts A no charge rental unit is provided at no charge during the warranty period of the product when we perform the repair service m GE Medical Systems Information Technologies pays the shipping charges for a loaner sent to the customer for product repairs under the warranty m Rental units are available in non warranty situations m Thecustomer pays the shipping charges to return a r
103. r 3 13 Installation Configuring Your V100 Monitor Displayed on Monitor Function 6 lin min window Language The number displayed in Pulse Rate display window indicates the language setting These range from 0 to 20 For example 0 indicates English The language setting is used in printed reports Russian Greek Korean Chinese and Japanese are printed in English only VO Y 00 E NR O pa Eh Ebo Rc pec RES Reo qus COND C1 P CJ P0 Ro H Ne 20 English Chinese Czech Danish Dutch Finnish French German Greek Hungarian Italian Japanese Korean Norwegian Polish Portuguese Brazilian Portuguese Continental Russian Slovak Spanish Swedish In MAP Cuff window of remaining saves possible In order to save any changes made in config mode press and hold the menu button until a tone sounds Warning The number displayed in the MAP Cuff window will decrease each time the Save Settings operation is done If it reaches zero a fatal 975 alarm calibration space exhausted results and the unit will have to be serviced before operation will be possible again 3 14 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Installation Host Communications Connector Host Communications Connector All host port signals are NON ISOLATED and should be connected to equipment conforming to IEC 60601 1 1 ONLY Where isolation of data communication is required the i
104. r trademarks OxyTip Pl TruSat TruSignal TruTrak are the property of GE Medical Systems Information Technologies a division of General Electric Corporation All other product and company names are the property of their respective owners Alaris Turbo Temp and IVAC are trademarks of Cardinal Health Inc CRITIKON DINAMAP SuperSTAT and DURA CUF and SOFT CUF Blood Pressure Cuffs are trademarks of GE Medical Systems Information Technologies Masimo SET LNOP and LNCS are trademarks of Masimo Corporation Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would alone or in combination with this device fall within the scope of one or more of the patents relating to the device Nellcor OxiMax C LOCK and SatSeconds are trademarks of Nellcor Puritan Bennett T 2 CARESCAPE V100 Vital Signs Monitor 2037106 001 B 17 September 2008 Contents 1 Introduction 1 1 Revision History een ee nee wees 1 3 Manual Purpose ara a irn ds 1 3 Ordering Manuals sssssueeeeeeeeee eee nnns 1 3 Safety Information ccc ccc ccc cece cece kaka 1 3 Responsibility of the Manufacturer lt 1 4 GenetQl e near en rennen ER UE ER 1 4 References to Persons Places and Institutions 1 4 Warnings Cautions and Notes Laikais 1 5 Product Specitio EldzGldS c acer ctr eee teet qeu Ri ME nerd 1 5 Equipment S
105. rview Equipment Description Equipment Description Product Configurations The CARESCAPE V100 Vital Signs Monitor provides a small portable easy to use monitoring alternative for sub acute hospital and non hospital settings The V100 is for use on adult pediatric or neonatal patients one at a time The battery operated monitor offers noninvasive determination of systolic blood pressure diastolic blood pressure mean arterial pressure pulse rate oxygen saturation and temperature Monitors are available with or without integrated printers as well as the following parameters and technologies m NIBP Pulse SuperSTAT Auscultatory Classic m SpO Ohmeda TruSignal Nellcor or Masimo m Temperature Alaris Turbo Temp The model of the monitor determines which parameters are in your monitor Please refer to applicable sections Using the V100 Monitor a clinician can measure display and record patient vital sign data that is derived from each parameter The monitor is also capable of alerting the clinician to changes in the patient s condition or when it is unable to effectively monitor the patient s condition All of the main operations of the V100 Monitor are easy to use and only a button touch away Please review the factory default settings and where applicable enter settings appropriate for your use Each CARESCAPE V100 Monitor is supplied with an accessory pack The contents of the pack vary according to model Unpack th
106. s If powering the Monitor from an external power adapter or converter use only GE Medical Systems Information Technologies approved power adapters and converters The Monitor does not include any user replaceable fuses Refer servicing to qualified service personnel To reduce the risk of electric shock do not remove the cover or the back Refer servicing to a qualified service person If the accuracy of any determination reading is questionable first check the patient s vital signs by alternate means and then check the V100 Monitor for proper functioning Use of portable phones or other radio frequency RF emitting equipment near the system may cause unexpected or adverse operation 2037106 001 B CARESCAPE V100 Vital Signs Monitor 1 5 Introduction Safety Information NOTE WARNINGS The equipment or system should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the equipment or system should be tested to verify normal operation in the configuration in which it is being used The use of accessories transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the equipment or system CAUTIONS Do not use replacement batteries other than the type supplied with the Monitor Replacement batteries are available from GE Medical Systems Accessories and Supplies The V100 Monitor is de
107. s the basic operating cycle for an NIBP determination Inflation Time LLI Wait Time N N U 52 as 7 5 LL ES Evaluation Time O Deflation Time Determination Time Cycle Time TIME SuperSTAT NIBP auto mode If systolic pressure is not found the SuperSTAT algorithm can search at cuff pressures higher than the initial target pressure The algorithm will inflate above the initial target pressure to obtain more data in the systolic region The pressure is limited to the maximum allowed for the selected patient type The SuperSTAT algorithm evaluates the data obtained during the determination and the prior determination if it is available to determine if additional data is needed to complete the determination It can then selectively pump to a single cuff pressure to obtain the data it needs and then return to the existing deflation sequence This search process makes SuperSTAT more efficient Accuracy ofthe DINAMAP NIBP measurements was validated against the intra arterial method Do not use the auscultatory method to verify the accuracy of the SuperSTAT NIBP parameter The auscultatory method using the cuff and stethoscope determines the systolic and diastolic pressures from sounds that occur during cuff deflation Mean arterial pressure cannot be determined by this method The oscillometric method used with all DINAMAP technologies determines systolic mean and diastolic pressures for the oscillations that occ
108. se is approximately equal to the amount of carboxyhemoglobin present Dyes or any substance containing dyes that change usual arterial pigmentation may cause erroneous readings Sensor light source Wavelength Infrared 905 nm nominal Red 660 nm nominal Power dissipation Infrared 22 5 mW max Red 27 5 mW max Masimo SET Technology with LNOP Blue sensors have been validated for no motion accuracy in human blood studies on neonatal infant and pediatric patients with congenital cyanotic cardiac lesions in the range of 6096 to 10096 SpO against a laboratory co oximeter This variation equals plus or minus one standard deviation which encompasses 68 of the population Information about wavelength range can be especially useful to clinicians Temperature Temperature Specifications Scale Fahrenheit FJ Celsius C Range Predictive mode Max 41 1 C 106 0 F Min 35 6 C 96 0 F Monitor mode Max 41 1 C 106 0 F Min 26 7 C 80 0 F Monitor mode accuracy 0 1 C 0 2 F when tested in a calibrated liquid bath meets ASTM E1112 Table 1 in range specified 2037106 001 B CARESCAPE V100 Vital Signs Monitor A 11 Technical Specifications and Default Settings Default Settings Temperature Specifications Scale Fahrenheit FJ Celsius C Determination time approx 10 seconds typical NOTE Use only IVAC probes and P850A probe
109. signed to conform to Electromagnetic Compatibility EMC standard IEC 60601 1 2 and will operate accurately in conjunction with other medical equipment which also meets this requirement To avoid interference problems affecting the Monitor do not use the Monitor in the presence of equipment which does not conform to these specifications Place the V100 Monitor on a rigid secure surface Monitor must only be used with mounting hardware poles and stands recommended by GE Medical Systems Information Technologies The weight ofthe accessory basket contents should not exceed 5 Ib 2 7kg Arrange the external AC DC power converter air hoses and all cables carefully so they do not constitute a hazard Verify calibration of NIBP parameter temperature and pulse oximeter do not require calibration Ensure that the display is functioning properly before operating the V100 Monitor Do not immerse the Monitor in water If the Monitor is splashed with water or becomes wet wipe it immediately with a dry cloth Do not gas sterilize or autoclave Caution should be taken to not set ALARM LIMITS to extreme values as this can render the ALARM SYSTEM useless The V100 Monitor when used with GE Medical Systems Information Technologies approved applied parts and accessories is protected against defibrillator damage The electromagnetic compatibility profile of the V100 Monitor may change if accessories other than those specified for use
110. solated level converter should be used If external alarm control is required p n 487208CR Isolated Remote Alarm Cable Assembly should ALWAYS be used Please refer to the Information Sheet included with the isolated remote alarm cable for operational details NOTE When using remote alarm the V100 Monitor should be considered the primary alarm source The secondary alarm is used for secondary purposes only DB15 Connector Pin Assignments Connection Details Host Port Connector rear panel WARNING Auxiliary equipment connected to the V100 Monitor will result in the formation of an electromedical system and thus must comply with the requirements of EN 60601 1 1 IEC 60601 1 All host port signals are NON ISOLATED and should be connected to equipment conforming to IEC 60601 1 configured to comply with IEC 60601 1 1 ONLY Where isolation of data communication is required GE Medical Systems Information Technologies part number ILC1926 should be used If external alarm control is required GE Medical Systems Information Technologies part number 487208CR Isolated Remote Alarm Cable When a high priority alarm condition is displayed on the Monitor the remote alarm signal becomes active within 0 5 seconds The active state of the alarm signal is an open circuit In the inactive state the alarm signal is connected to ground Please refer to the Information Sheet included with the isolated remote alarm cable for operational details NOTE W
111. splayed on the Systolic window and audible alarm sounds Remove the air restriction Press Start Stop and verify that the pump does not start Press the Silence button Press the Silence button again Verify the alarm condition is cleared from the Systolic window Temperature Perform if equipped with Temp module The Alaris Turbo Temp probes cannot be calibrated These probes must be discarded after 2 years from the date of manufacture stamped into the RJ45 connector first two digits year second two digits week Refer to the illustration example 0520 fw20 in 2005 NOTE It is the responsibility of the user to maintain proper records NN PO no P Alaris Turbo Temp Probe Date Code Turn Monitor off Make sure the temp probe is properly stored in the probe well Disconnect the temp probe cable from the monitor Connect Temp simulator set to 80 2 F Turn the Monitor on Put the Monitor into temp monitor mode a partially remove the probe from the well stop when you hear the Monitor beep 2037106 001 B CARESCAPE V100 Vital Signs Monitor 4 15 Maintenance Parameter Level Functional Testing A b Quickly re insert the probe and remove again you should hear two beeps of a different tone c Atemperature value should appear quickly if not repeat Step 5b Record and verify the reading in the temp display is 80 2 F 0 2 F Set the simulator to 98 6 F Record and verify the reading in the temp disp
112. ssory Nellcor Ear Clip D YSE Sensor for 70124033 70124034 SpO Accessory Nellcor Ta pe ADH A N use with 70124035 2016130 001 SpO gt Accessory Nellcor Tape ADH P I use with Oxi P I Sensors 2016131 001 SpO Masimo SpO gt Sensor Masimo LNOP Disposable Adhesive Sensor LNOP Adt Adult 2010458 001 20 box SpO Sensor Masimo LNOP Disposable Adhesive Sensor LNOP Pdt 2010459 001 Pediatric 20 box SpO Sensor Masimo L Neonata NOP Disposable Adhesive Sensor LNOP NeoPT 20 box 2010461 001 SpO Sensor Masimo L NOP Disposable Adhesive Sensor Bridge LNOP Neo Neonatal 20 box 2010460 001 SpO Sensor Masimo L Neonata NOP Disposable Adhesive Sensor LNOP Neo L 20 box 2017089 001 SpO Sensor Masimo L Neonata NOP Disposable Adhesive Sensor LNOP NeoPT L 20 box 2017090 001 SpO Sensor Masimo L NOP Adtx Disposable Adhesive Sensor Transparent Tape LNOP Adult 20 box 2027269 001 SpO Sensor Masimo L NOP Pdtx Disposable Adhesive Sensor Transparent Tape LNOP Pediatric 20 box 2027270 001 SpO Sensor Masimo L Sensor Neonatal Adult 20 box NOP Disposable LNOP Disposable LNOP Hi Fi 2027272 001 SpO Sensor Masimo L Sensor Infant Pediatric 20 box NOP Disposable LNOP Disposable LNOP Hi Fi 2027271 001 SpO Sensor Masimo L nfant Thumb Toe Sensor
113. ssure pulses used by simulators During the deflation of the cuff the shape of the generated pressure oscillations changes as the cuff goes from systolic to diastolic pressures This is due to the fact that the artery is only open when the arterial pressure is above cuff pressure As can be seen in Figures 1A 1C the shape of the oscillation changes as the cuff pressure changes and the artery opens Commercial NIBP simulators use one waveform shape at all pressure levels which is simply scaled to reflect the oscillometric envelope In addition the shape of the oscillation generated by commercial simulators does not match the shape of a typical oscillation measured during clinical 2037106 001 B CARESCAPE V100 Vital Signs Monitor B 3 Appropriate Use of NIBP Simulators Appropriate Use of NIBP Simulators testing Figures 2A 2B These differences in the shape of the pulses can effect how an NIBP monitor analyzes the oscillometric envelope While it is possible to develop an algorithm which produces readings that correspond to the simulator settings it is preferable to use the clinical data for algorithm development Figure 1A Cuff Oscillation At Systolic Pressure Invasive Pressure Cuff Pressure ES A c MAP 110mmHg NV Res 25500 255 50 254 00 zei 255 00 255 50 N Figure 18 Cuff Oscillation From A Clinical Measurement I Invasive Pressure Cutt Pressure N hakimin Diastolic rimmHg
114. t uA 300 SpO Circuit Leakage Current LA 300 2037106 001 B CARESCAPE V100 Vital Signs Monitor 4 19 Maintenance Test Results Form 4 20 CARESCAPE V100 Vital Signs Monitor 2037106 001 B 5 Troubleshooting For your notes 5 2 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Troubleshooting Alarm Code Interpretation Alarm Code Interpretation If any other alarms appear that are not listed in the paragraphs that follow record the error message and report the failure to Customer Support Refer to the operation manual for information about patient alarms and general procedural alarms System Failures When a system failure is encountered the error code is displayed on the screen for gt 5 seconds and the system enters failsafe mode The error code is logged in the history log Pressing and holding the On Off button for between 10 and 20 seconds results in a fatal alarm The same fatal alarm occurs when reconnecting the battery refer to Maintenance Section for more detailed information on replacing batteries General system error codes are listed below If any other system or similar code appears report it to Customer Support Alarm Conditions and Error Codes When responding to a monitor alarm always CHECK THE PATIENT FIRST and then check the Monitor cuff hose and sensors Press SILENCE to reset patient alarm conditions Error Log You can view and
115. t detects two pulsations of relatively equal amplitude The time between deflation steps depends on the frequency of these matched pulses pulse rate of the patient However if the monitor is unable to find any pulse within several seconds it will deflate to the next step The process of finding two matched pulses at each step provides artifact rejection due to patient movement and greatly enhances the accuracy of the monitor The figure shows a full determination sequence for an adult patient In Stat mode some steps may require only one pulse Pump Up Pressure 180 Target Pressure 135 I CUFF PRESSURE II TIME I Full NIBP determination sequence for adult At each step the microprocessor stores cuff pressure the matched pulse amplitude and the time between successive pulses The stepped deflation and matched pulse detection continues until diastolic pressure is determined or total cuff pressure falls below 8 mmHg The parameter then deflates the cuff to zero detected pressure analyzes the stored data and updates the screen 2 10 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Equipment Overview DINAMAP SuperSTAT Algorithm Systolic Search The operating cycle is composed of four parts inflation time deflation time evaluation time and wait time Wait time which varies from mode to mode is affected by the cycle time auto mode or operator intervention manual mode The figure show
116. take place as long as the monitor remains connected to an external DC power source Charge battery pack for 12 hours before first use or after prolonged periods of storage If the monitor is idle for extended periods it should be fully charged at least once a month to ensure optimum performance The battery pack should be charged before use because a charged battery loses charge when left in storage Sealed lead acid batteries can discharge to less than 80 of charge within 60 days of storage Charging is done automatically by the monitor when the external DC power is connected The battery pack should be charged at room temperature 59 F to 86 F 16 C to 30 C You can charge or top off the battery pack at any time Do not have to wait until battery is fully discharged To prolong the life of the battery keep the monitor connected to a DC power supply whenever possible Do not allow the battery to become completely discharged A fully charged battery will power the monitor for approximately 8 11 hours depending upon configuration and usage To ensure full charge cycles replace only with a the specified battery If the monitor is to be stored for some time first charge the battery and then remove it and store it separately from the monitor 3 4 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Installation Connections BATTERY OK Battery Alarms When the Monitor is operating on battery power and t
117. tions Measurement range Low perfusion 70 to 100 x2 digits during clinical low perfusion Pulse rate Adult Neonate 30 to 250 bpm 2 digits or 2 whichever is greater without motion 30 to 250 bpm 5 digits during motion Low perfusion 30 to 250 bpm 3 digits SpO gt measurement accuracy is based on deep hypoxia studies using OxyTip sensors on healthy adult volunteer subjects Arterial blood samples were analyzed simultaneously on multiple CO oximeters This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population Applicability OXY AF and OXY AP sensors NOTE Accuracy may vary for some sensors always check the instructions for the sensor Specifications Ohmeda sensor accuracy Sensor model SpO range 70 to 100 OxyTip OXY F UN 2 digits without motion OXY W UN 2 digits without motion OXY E UN 2 digits without motion OXY SE 2 digits without motion OXY AP 2 digits without motion OXY AF 2 digits without motion OXY F2 GE 2 digits without motion OXY F4 GE 2 digits without motion OXY E2 GE 2 digits without motion OXY E4 GE 2 digits without motion Sensor light source Wavelength Infrared 930 to 950 nm nominal Red 650 to 670 nm nominal Average power 1mW Information about wavelength range can be especially
118. unting Bracket 12W Power supply roll stand bracket 2016929 001 6 6 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Parts List Drawings and Replacement Service Parts Part Part description Part number Connectivity ILC1931 DINALINK ApexPro Adapter 001931 ILC1926 Isolated Level Convertor 001926 ILC1931 DINALINK ApexPro FH adapter 001932 Cable Assy use with 001932 Cable assembly to use with 001932 394119 008 Cable Assy use with 001931 Cable assembly telemetry interface DINALINK 418497 002 Cable Assy use with 001926 Cable assembly DINAMAP to ILC 683235 001931 001932 Patient ID Patient ID IR Cable used with IR adaptor kit 2024500 001 Patient ID Kit IR adaptor kit with bracket 2026273 002 Remote Alarm Remote Alarm Cable 487208CR Manuals Operation Manual Paper CARESCAPE V100 Operator s Manual Hard Copy 2036991 001 Service Manual Paper CARESCAPE V100 Service Manual Hard Copy 2037106 001 Service Manual CD CARESCAPE V100 Service Manual CD 2037107 001 2037106 001 B CARESCAPE V100 Vital Signs Monitor 6 7 Parts List Drawings and Replacement Service Parts Field Replaceable Units FRUs FRU List WARNING REPAIR TO THE FRU LEVEL Field repairs are recommended to the field replaceable unit FRU only Attempting a field repair on a PCB or a factory sealed
119. ur in the cuff during deflation WARNING Arrhythmias will increase the time required by the NIBP parameter to determine a blood pressure 2037106 001 B CARESCAPE V100 Vital Signs Monitor 2 11 Equipment Overview DINAMAP Classic and Auscultatory Reference Algorithm DINAMAP Classic and Auscultatory Reference Algorithm The oscillometric method of determining NIBP is accomplished by a sensitive transducer which measures cuff pressure and minute pressure oscillations within the cuff The first determination sequence initially pumps up to a cuff pressure of about 160 mmHg for adult pediatric patients or 110 mmHg for neonates depending on initial target pressure preset After inflating the cuff the monitor begins to deflate it and measures systolic pressure mean arterial pressure and diastolic pressure When the diastolic pressure has been determined the monitor finishes deflating the cuff and updates the screen The monitor deflates the cuff one step each time it detects two pulsations of relatively equal amplitude The time between deflation steps depends on the frequency of these matched pulses pulse rate of the patient However ifthe monitor is unable to find any pulse within several seconas it will deflate to the next step The process of finding two matched pulses at each step provides artifact rejection due to patient movement and greatly enhances the accuracy of the monitor The figure shows the NIBP determinati
120. ures ceno here UR Reed 4 11 Pneumatic Leakage Testing LL 4 12 Pressure Transducer Verification LL 4 12 Pressure Transducer Calibration lt 4 13 Overpressure Ver fICatlont rennen ee ees ec 4 13 Button Testing usi ee ee Ie EY 4 14 LED Testes xoxo eet eU DEUS UD ME QUU ENS 4 14 External DC Verification Lakis 4 14 NIBP Determination eee bp etr e eh Re apa 4 14 NIBP Overpressure Verification LL 4 15 Temperature Perform if equipped with Temp module 4 15 SpO2 Perform only if equipped with SpO2 module 4 16 Printer Qutp t TeSt ox epe a i 4 16 SGfety TestiMd encata ande d pe lp a a reda 4 17 SpO2 Circuit Leakage Test aaa 4 17 Temp Circuit Leakage Test cece cence eee ees 4 17 Test Results Form iere Esp rm lern I 4 18 Troubleshooting 5 1 Alarm Code Interpretation 222222eeeeeeeeeeeseennen nenn 5 3 SYSTEM FAIURES 5 s tenete ts te anal 5 3 Alarm Conditions and Error Codes lt 5 3 Error COO ae ee le dla secs ted Ded 5 3 Procedure to View and Print Error Code History Log 5 3 EHFOrCOdBS rs A T 5 5 Parts List Drawings and Replacement 6 1 Ordering Parts 22 idee sea ede 6 3 CARESCAPE V100 Vital Signs Monitor 2037106 0018 Service PA a E dai 6 3 Compatible Pascua a ai 6 3 Field Replaceable Units FRUS 00 00 ais 6 8 FRU EIS rs cist er A a ee eh ene 6 8 FRU PHOLOSs s steel 6 11 FRU Main Reference Guide
121. useful to clinicians A 6 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Technical Specifications and Default Settings Specifications Nellcor SpO Nellcor SpO Specifications Measurement range SpO gt 1t0 100 Pulse rate 20 to 250 bpm Perfusion range 0 05 to 2096 Accuracy Saturation Adult 70 to 10096 2 digits Neonate 70 to 100 3 digits Low perfusion 70 to 100 2 digits Pulse Rate Adult and neonate 40 to 250 bpm 3 digits Low perfusion 40 to 250 bpm 3 digits Adult specifications are shown for OxiMax MAX A and MAX N sensors with the N 600 Satura equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population Accuracy is based on deep hypoxia studies on healthy adult volunteer subjects Arterial blood samples were analyzed simultaneously on multiple CO oximeters Applicability OxiMax MAX A MAX AL MAX P MAX I and MAX N sensors tion accuracy will vary by sensor type This variation Specifications Nellcor sensor accuracy NOTE All Nellcor OxIMAx sensors must be used with the NELL cable the SCP 10 cable RS 10 and Oxisensor II sensors are not compatible with the V100 Vital Signs Monitor SpO Range Sensor Model E Ld 2 OxIMAx MAX A MAX AL 2 digits MAX N adult 2 digits MAX N neonate 3 digits MAX P 2
122. ustomer Support Before contacting Customer Support it is helpful to attempt to duplicate the problem and to check all accessories to ensure that they are not the cause of the problem If you are unable to resolve the problem after checking these items contact GE Medical Systems Information Technologies Prior to calling please be prepared to provide m product name model number and serial number m acomplete description of the problem CARESCAPE V100 Vital Signs Monitor 2037106 001 B Introduction Service Policy Service Packing Instructions Insurance If repair parts or service are necessary you will also be asked to provide m the product serial number m the facility s complete name address and account number m a purchase order number if the product is to need of repair or when you order spare parts m the facility s GE Medical Systems Information Technologies account number if possible m the appropriate part number for spare or replacement parts If your product requires warranty extended warranty or non warranty repair service call Customer Support and a representative will assist you To facilitate prompt service in cases where the product has external chassis or case damage please advise the Customer Support representative when you call The Customer Support representative will record all necessary information and will provide you with a Return Merchandise Authorization Number RMA Prior to returning any
123. ve Probe Off Technology algorithm Temperature Temperature blank Unt Cor F indicator illuminated 3 8 CARESCAPE V100 Vital Signs Monitor 2037106 001 B Installation Configuring Your V100 Monitor Pulse Rate Setting Window LED Display Window Comment Display Year Systolic XXX numeric Ye use amp keys to change Month MAP Cuff XXX numeric NEH use amp keys to change Day Diastolic XXX numeric JAY use amp keys to change Hour min XXX numeric Hr use amp keys to change Minute min XXX numeric Nin use amp keys to change 1 Mode Systolic blank CF6 indicates configuration mode when main screen is active NOTE Refer to the SpO Section of Operators Manual for detailed descriptions of the different user selectable SpO settings Setting the Date and Time To set the date and time on the V100 Monitor you must access the configuration mode Press Menu to skip the default settings that do not require changes Refer to the table above NOTE While in configuration mode all entries stored in the clinical history are erased when the time and or date is changed Procedures 1 Press the Menu button to move from one setting to another Use the buttons to increment or decrement the setting NOTE For the date and time to be saved you must advance the menu through the minute setting To exit the configuration mode press the On Off button To continue wit
124. ymbols 2c ccc ccc cee cece aaa aka 1 7 Service Requirements cece cece eee crac 1 9 Equipment ID 35 so e pre a eee lea aede ie o edd ae 1 9 Intended Audience o ocoococcoccncconccccn corra 1 9 Intended USE nase cer nenn 1 10 General USE iu Br en aan erheben 1 10 Related Mari dls s cscs sie nen dehnen 1 10 Service Policy ici reri p OUS Rr ee vier N des 1 10 Service Contracts s iss eee o dite eek er Rex an span drain qe 1 10 ASSISTONCE erroe td en EL TRUE dao 1 10 SERVICE cte SEL EROR RUMOR EE EEUU Ife See b E adt UR 1 11 P ckinglristr ctioris are ED 1 11 INSUPGNCE are Tai napa ana as E A 1 11 Service No Charge Rental ont acia nenn 1 12 REBAIL PARES 3 ee SR EN SR ere rd 1 12 Disposal of Product Waste cece cece cece cece eee eeeees 1 12 Batterlesu d an aie clea Via Waren NACE e RR ORA a Pan hala ee 1 12 Patient Applied POMS ici Zen 1 13 Packaging Material unseren 1 13 MONILOF CP 1 13 2037106 001B CARESCAPE V100 Vital Signs Monitor Equipment Overview 2 1 Equipment Description cc cece cece cece eect eee e 2 3 Product Configu rdtlols s oce denise ne en aE aan 2 3 Basic Components cc cece ccc cece cece ee nnne 2 4 BUttONS ne ra ab ue way ona a 2 4 Front Panel ere matoer cae nenn ea eee ENO Cine nenne 2 5 Product Compliance cece cece ccc eee eee nenne 2 7 Theory of Operation ccc ccc cece cece eee enn 2 8

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CARESCAPE™ V100 Vital Signs Monitor