Avalon FM20/FM30 Fetal/Maternal Monitor

Transcription

1 Avalon FM20/FM30 Fetal/Maternal Monitor Philips M2702A/M2703A Technical Data Sheet - Release J.3 The Philips Avalon FM20/FM30 fetal monitor offers a reliable, cost-effective, high-performance solution for fetal monitoring needs in clinics and hospitals, doctors practices and private households, from prenatal check-ups to antepartum monitoring of highrisk pregnancies, and during labor and delivery. With a cutting-edge feature set, including advance transducers, triplets monitoring, high-quality signal processing, and a touchscreen interface, the Avalon FM20/FM30 sets new standards for performance, flexibility, convenience, and ease of use. The unique Smart Pulse measurement integrated in the Toco transducer simplifies monitoring. Without an additional sensor, the maternal pulse rate is monitored and continuously compared with the heart rate from the fetal sensor (cross-channel verification). In combination with an Avalon CL Transducer System all fetal and maternal measurements can be monitored cableless, including twins, triplets, and Smart Pulse. The battery option gives monitoring flexibility e.g. for in-house transport or bridging mains power outage.

2 Features (FM20/FM30) Transducers and Measurements Smart transducers are comfortable to wear, waterproof, and easy to clean Ultrasound fetal heart rate monitoring of a singleton, twins, and even triplets Fetal Movement Profile (FMP) automatically detects fetal body movements for antepartum applications using ultrasound transducer External uterine activity (Toco) monitoring Smart Pulse integrated in the Toco MP transducer detects the maternal pulse rate without the need for an additional sensor (SpO 2 or MECG), and reassures correct fetal heart rate monitoring Cross-Channel Verification (CCV) detects coincidence between all fetal and maternal heart/pulse rates NST timer for antepartum applications al Non-Stress Test (NST) report software allows interpretation of fetal heart rate and Toco traces, and generates a printed report automatically for an NST, using NICHD guidelines from 2008 for electronic fetal heart rate monitoring al Maternal non-invasive blood pressure including pulse rate Heart rate with maternal ECG (MECG) Cableless monitoring in connection with an Avalon CL or Avalon CTS Fetal Transducer System Monitoring of maternal temperature in connection with the Tympanic Temperature Module Entering of manually taken maternal temperature FM30 ONLY Direct fetal heart rate monitoring with fetal ECG (DECG) including waveform display Intrauterine (IUP) pressure monitoring al Maternal pulse oximetry (SpO 2 ) and continuous maternal pulse rate Monitor High-resolution color TFT touchscreen display with a wide viewing angle, displaying fetal and maternal measurements are as large, easyto-read numerics Intuitive user functionality via the touchscreen Quick and simple cleaning due to the absence of mechanical controls Optimized size and presentation of measurements with automatic screen layouts Displaying information such as: Patient identification (including the bed label when connected to a surveillance system such as OB TraceVue/IntelliSpace Perinatal), date and time, alarm information, recorder status, and prompt and error messages Fast access to functions e.g. starting a recording or resetting the Toco baseline via Configurable SmartKeys Adjustment of the heart rate and alarm volume with an indication of the current setting Automatic channel management allowing free selectable connection of all wired fetal transducers, patient module, or remote event marker to any of the fetal sensor sockets at the left side of the monitor Identification of the relation between transducer and numeric through a blue transducer Finder LED, while the position indicator on the screen shows to which fetal sensor socket a transducer is connected Comprehensive patient data presentation, including at-a-glance patient identification, and the choice to add user-configurable notes (Roman-8 character set) al battery operation based on a built-in Smart Battery (M4605A) and on an external AC/DC power supply (M8023A #E25 option); the monitor can operate using battery power for at least four hours Recorder (FM20/FM30) Built-in six-inch high-resolution thermal array recorder with paper type detection and paper-out warning Trace output of fetal and maternal heart rates, fetal movements, and uterine activity and annotation of time, date, trace identification symbols, patient information, and software versions Maternal noninvasive blood pressure values are annotated at the end of the measurement Internal backup memory for at least 7 hours of trace data (>3.5 hours with previous hardware revision <A 00.18): Stored data recording to print a specific patient episode from a selected patient at high speed, even multiple times Bridge paper-out for printing the remaining trace data after new paper has been loaded Data recovery after an interruption of the online data transmission to an OB TraceVue/IntelliSpace Perinatal system over a LAN connection. Paper Save Mode for maternal measurements 2

3 FM30 ONLY Maternal heart rate, SpO 2 saturation, and pulse rate values are printed every five minutes Recording of six-second MECG and/or DECG wave snapshots with 25 mm/sec scaling in parallel or separate to the fetal traces Alarms When an alarm condition is fulfilled, it is signaled by the monitor in the following ways: An alarm tone sounds An alarm message is shown on the screen The numeric of the alarming measurement flashes on the screen ALARM CATEGORIES Physiological Alarms for fetal and maternal parameters (to indicate vital sign alarm limit violations, for instance) Technical Alarms (INOPs) are triggered by signal quality problems, equipment malfunction, or equipment disconnect ALARM MODES INOP only: INOPs are enabled, with audible and visual indication active (default setting) All: patient alarms and INOPs are enabled, with audible and visual indicators active ALARM SUSPENSION Alarms Off/Pause Alarms function Alarm pause period: indefinite, or one, two, or three minutes ALARM LATCHING/NON-LATCHING Visual Audible Visual and audible Standard Interfaces Cableless monitoring using the Avalon CL Transducer System, or the Avalon CTS Cordless Transducer System with connection at the fetal sensor socket al Interfaces (FM20/FM30) LAN/RS-232 System Interface The LAN/RS-232 interface has two fully isolated ports: The LAN port is for connecting the monitor to an OB TraceVue/ IntelliSpace Perinatal obstetrical information and surveillance system (revision E.0 or later) on a network. OB TraceVue/IntelliSpace Perinatal controls all patient admit/discharge events. The RS-232 port can be used for connecting the monitor to an obstetrical information and surveillance system, such as OB TraceVue/IntelliSpace Perinatal. Dual system interface support. If an obstetrical information and surveillance system is connected via LAN, another information system (EMR) can be connected via RS232 in read-only mode. Flexible Nurse Call Interface Means for alarms generated on the monitor to be signaled on an external device such as a nurse call system, a beeper, or a light Providing three general alarm relays Connection of the external device to the alarm relay of the monitor, and configurable alarm criteria Active open and closed contacts and a user-definable delay time MIB/RS-232 Interface MIB, Medical Information Bus (IEEE P1073), is a standard for interfacing medical devices, used for the Data Export functionality to export measurement values from the monitor to other devices, or to connect the Tympanic Temperature Module Device Interface (USB Interfaces) Allowing connection of USB devices (mouse, keyboard, bar code reader) to the monitor Service Features (FM20/FM30) The Configuration Mode is password-protected and allows trained users to customize the monitor configuration The Demo Mode is password-protected and is intended for training and educational purposes The Service Mode is password-protected and ensures that only trained staff can access service tests and tasks The Support Tool uses the LAN interface of the fetal monitor The Support Tool helps technical personnel to carry out configuration, upgrades, and troubleshooting on an individual monitor share configuration settings between monitors back up the monitor settings Related Products (FM20/FM30) Avalon CL and Avalon CTS Transducer System The monitor is compatible with the Avalon CL and CTS, allowing expectant mothers to be continuously monitored without wires, whether in the bath or shower, in the bed, or while ambulating. Refer to the Avalon CL and the Avalon CTS Data Sheets for further information. Avalon CL Transducer System Avalon CTS Transducer System 3

4 Tympanic Temperature Module The monitor is compatible with the Tympanic Temperature Module allowing the monitoring of maternal temperature. The temperature is taken in the ear, but result of this measurement can be automatically adjusted to correspond to a different body reference site. The result is shown on the display of the thermometer and transmitted to the monitor. Refer to the Tympanic Temperature Module Data Sheet for further information. The monitor is classified as electromagnetic emissions Class B, except whenever used with the IUP/ECG patient module M2738A, when it is classified as Class A. This ISM device complies with Canadian ICES-003. Cet appareil ISM est conforme à la norme NMB-001 du Canada. Environmental Specifications (FM20/FM30) The monitor may not meet the given performance specifications if stored and used outside the specified temperature and humidity ranges. Tympanic Temperature Module Regulatory and Standards Compliance (FM20/FM30) The monitor is in conformity with the requirements of the European Medical Devices Directive 93/42/EEC and the following major international standards: Safety, Performance IEC :2005+A1:2012 / EN :2006+AC:2010 IEC :2010 / EN :2010 IEC :2006+A1:2012 / EN :2007+AC:2010 IEC :2011 / EN :2001 ANSI/AAMI ES :2005+A1:2012+C1:2009+A2:2010 CAN/CSA C22.2# JIS T AS/NZS The possibility of hazards arising from hardware and software errors was minimized in compliance with ISO 14971:2012, IEC :2005+A1:2012/EN :2006+AC:2010. Alarm sounds are compliant with Standard IEC :2006+A1:2012 / EN :2007+AC:2010. Electromagnetic Compatibility IEC :2007/EN :2007+AC:2010 ICES-003:2012 FM20/FM30 Monitor Temperature Range Operating without battery: 0 C 45 C (32 F 113 F) with fully charged battery: 0 C 40 C (32 F 104 F) with battery charging: 0 C 35 C (32 F 95 F) Storage -20 C 60 C (-4 F 140 F) (except recorder paper) Humidity Range Operating <95% relative 40 C (104 F) Storage <90% relative 60 C (140 F) (except recorder paper) Altitude Range Operating m ( ft.) Storage m ( ft.) Transducers (M2734B/M2735A/M2736A/M2738A) Temperature Range Operating 0 C 40 C (32 F 104 F) Storage -20 C 60 C (-4 F 140 F) Humidity Range Operating <95% relative 40 C (104 F) Storage <90% relative 60 C (140 F) Altitude Range Operating m ( ft.) Storage m ( ft.) FOR FM30 ONLY Philips SpO 2 Sensors Operating Temperature Range Reusable sensors (M119xX) 10 C 37 C (50 F 98.6 F) Disposable sensors (M113xA) 0 C 55 C (32 F 131 F) 4

5 Physical Specifications (FM20/FM30) FM20/FM30 Monitor Power (without battery option) Supply Voltages 100 VAC 240 VAC ± 10% Supply Frequency Range 50 Hz 60 Hz Power consumption (current) A Dimensions and Weight Size mm/(in) ±1%: W x H x D 286 x 133 x 335 mm ± 1% (without options) (11.3 x 5.2 x 13.2 in ± 1%) Weight without battery 5.1 kg (11.2 lbs) Weight with battery 5.3 kg (11.7 lbs) Classifications Degree of Protection Against Type CF Electrical Shock Electrical Class Class II equipment Mode of Operation Continuous operation Startup Time (Time taken < 30 seconds from switching on the monitor to seeing the first parameter labels) Ingress Protection IP X1 (provided recorder drawer is shut) Transducers (M2734B/M2735A/M2736A/M2738A) Shock Resistance Withstands a 1 m drop to concrete surface with possible cosmetic damage only Water Ingress Protection Code M2734B/M2735A/ IP 68 (immersion up to 1 m water depth M2736A for 5 hours) M2738A IP 67 (immersion up to 0.5 m water depth for 30 minutes) Dimensions and Weight M2734B/M2735A/ Size (diameter) 83 mm (3.27 in.) M2736A Weight (without < 220 g (7.8 oz.) cable) M2738A Maximum size 50 x 28 x 135 mm mm/(in.): (2.0 x 1.1 x 5.3 in.) W x H x D Cable length 2.5 m Weight < 150 g (5.3 oz.) Degree of Protection Against Electrical Shock Type CF Performance Specifications (FM20/FM30) Complies with IEC :2007/EN :2008. ECG measurement follows IEC :2011+AC:2012/EN :2006+AC:2006 except clauses listed below: , Fetal/Maternal Performance Specifications Ultrasound Measurement Method Measurement Range US Resolution Display 1 bpm 200 bpm US Intensity US Frequency Printer Average output power Peak rarefactional pressure Output beam intensity (I ob ) (= spatial average - temporal average intensity) Spatial-peak temporal average intensity Effective radiating -12 db Ultrasound Pulsed Doppler bpm 1/4 bpm 3 bpm P = (7.4 ± 0.4) mw p r = (40.4 ± 4.3) kpa I ob = I sata = (2.38 ± 0.59) mw/cm2 I spta = (15.0 ± 3.2) mw/cm 2 (3.11 ± 0.74) cm 2 1 MHz ± 100 Hz US Signal range 3.5 μvpp US Burst Repetition Rate 3.0 khz Signal Quality Indication Duration Good Acceptable Poor Beat to Beat Change (max.) for Ultrasound Toco Measurement Method Sensitivity Hz 100 μs Full Half-full Empty 28 bpm Resolution Display 1 unit Measurement Range Printer Strain Gauge Sensor Element 1 unit = 2.5 g 1/4 unit 400 units 5

6 Fetal/Maternal Performance Specifications Signal Range Units Maximum Offset Range -300 units Baseline Setting 20 units Auto Offset Correction 3 seconds after connecting the transducer, the Toco value is set to 20 units Auto Zero Adjust Toco value is set to zero following a negative measurement value for 5 seconds Pulse from Toco MP Range bpm Accuracy ±2% or 1 bpm, whichever is greater Resolution 1 bpm Wavelength Range nm Emitted light energy 15 mw Maternal Heart Rate Measurement Range bpm Resolution Display 1 bpm Recorder 1/4 bpm Accuracy ± 1 bpm or 1%, whichever is greater Filter Bandwidth Hz Inop Auxiliary Current (Leads Off < 100 μa Detection) Input Signal Range MECG 150 μvpp to 6 mvpp Defibrillator Protection None ESU Protection None FM30 ONLY Direct and Maternal ECG DECG Single Lead ECG (derived from Fetal Scalp Electrode) MECG Single Lead ECG (derived from RA and LA electrodes) DECG Input Signal 20 μvpp to 6 mvpp IUP Measurement Method Passive Resistive Strain Gauge Elements Measurement Range mmhg Signal Range mmhg Resolution Display 1 mmhg Printer 1/4 mmhg Sensitivity 5 μ/v/mmhg Offset Compensation mmhg IUP Baseline Setting Accuracy (not including sensor accuracy) Auto Offset Correction Alarm Specifications (FM20/FM30) 0 mmhg ± 0.5% per 100 mmhg 3 seconds after connecting the transducer, the IUP value is set to 0 mmhg Fetal Heart Rate (Ultrasound Alarm Specifications FHR/DECG Alarm Limits Bradycardia bpm adjustable in 10 bpm steps (low limit) Default: 110 bpm Tachycardia bpm adjustable in 10 bpm steps (high limit) Default: 170 bpm FHR/DECG Alarm Delay Bradycardia seconds in steps of 10 s (low limit) Default: 240 s Tachycardia seconds in steps of 10 s (high limit) Default: 300 s Signal Loss seconds in steps of 10 s Delay MHR/MECG Alarm Specifications High Range bpm adjustable in 1 bpm steps (30 40 bpm), and 5 bpm steps bpm) Default: 120 bpm Low Range bpm adjustable in 1 bpm steps (30 40 bpm), and 5 bpm steps bpm) Default: 50 bpm Tachycardia Difference to high limit: 0 50 bpm adjustable in 5 bpm steps, Default: 20 bpm Clamping at: bpm adjustable in 5 bpm steps, Default: 200 bpm Bradycardia Difference to low limit: 0 50 bpm adjustable in 5 bpm steps, Default: 20 bpm Clamping at: bpm adjustable in 5 bpm steps, Default: 40 bpm Noninvasive Blood Pressure (FM20/FM30) Measurement Validation: In adult mode, the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP ) in relation to mean error and standard deviation, when compared to intra-arterial or auscultatory measurements (depending on the configuration) in a representative patient population. For the auscultatory reference the 5th Korotkoff 6

7 sound was used to determine the diastolic pressure. Complies with IEC :2010/EN :2010. Noninvasive Blood Pressure Performance Specifications Measurement Systolic mmhg (4 36 kpa) Ranges Diastolic mmhg ( kpa) Mean mmhg ( kpa) Accuracy Max. Std. Deviation: 8 mmhg (1.1 kpa) Max. Mean Error: ± 5 mmhg (± 0.7 kpa) Pulse Rate Range bpm Accuracy bpm: ± 5 bpm (average bpm: ± 5% of reading over noninvasive bpm: ± 10% of reading blood pressure measurement cycle) Measurement Time Typical at HR > 60 bpm Auto/manual: 30 seconds maximum time: 180 seconds Cuff Inflation Time Typical for normal cuff: Less than 10 seconds Initial Cuff Inflation Pressure 165 ± 15 mmhg Auto Mode Repetition Times 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45, 60, or 120 minutes Venipuncture Mode Inflation Inflation Pressure mmhg (3 16 kpa) Automatic deflation after 170 seconds ALARM SPECIFICATIONS NBP (FM20/FM30) Alarm Specifications Range Adjustment Systolic mmhg ( mmhg: 36 kpa) 2 mmhg (0.5 kpa) Diastolic mmhg (1.5 > 30 mmhg: 32 kpa) 5 mmhg (1 kpa) Mean mmhg ( kpa) Overpressure Settings Adjustment > 300 mmhg (40 kpa) > 2 sec not user adjustable SpO2 (FM30 only) Maternal pulse oximetry provides SpO2, pulse numerics, and a pulse trace for oxygen saturation (SpO2) of maternal aterial hemoglobin. Pulse rate is derived from SpO 2 if ECG is not connected. Complies with ISO :2011/EN :2011 (except alarm system; alarm system complies with IEC :2011/EN :2001). Measurement Validation: The SpO 2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to COoximeter measurements. Display Update Period: Typical: 2 seconds, Maximum: 30 seconds. Maximum with noninvasive blood pressure INOP suppression on: 60 seconds. The specified accuracy is the rootmean-square (RMS) difference between the measured values and the reference values. SpO 2 Performance Specifications Range 0 100% Accuracy Philips Reusable Sensors: M1191A/B, M1191AL/BL, M119 1ANL, M1192A, M1192AN = 2% (70% to 100%) M1191T, M1192T, M1194A, M1194AN, M1196A, M1196T = 3% (70% to 100%) Philips Disposable Sensors with M1943A(L): M1131A, M1901B, M1903B, M1904B = 3% (70% 100%) M1133A, M1134A = ±2% (70% 100%) NellcorPB Sensors with M1943A(L): MAX-A, MAX-AL, MAX-P, MAX-N, D-25, D-20, N-25, OxiCliq A, P, N = 3% (70% 100%) Accuracy Masimo Reusable Sensors with LNOP MP12 or LNC MP10: LNOP DC-I, LNOP DC-IP, LNOP YI, LNCS DC-I, LNCS DC-IP: 2% (70% 100%) LNOP TC-I, LNCS TC-I: 3.5% (70% 100%) Masimo Disposable Sensors with LNOP MP12 or LNC MP10: LNOP Adt, LNOP Adtx, LNOP Pdt, LNOP Pdtx, LNCS Adtx, LNCS Pdtx: 2% (70% 100%) LNOP Neo-L, LNCS Neo-L: 3% (70% to 100%) Resolution 1% Pulse Range bpm Accuracy ± 2% or 1 bpm, whichever is greater Resolution 1 bpm 7

8 SpO 2 Performance Specifications Sensors Wavelength nm information about the wavelength range range can be especially useful to clinicians (for instance, when photodynamic therapy is performed) Emitted 15 mw Light Energy Pulse 70% 100% Oximeter Calibration Range ALARM SPECIFICATIONS SPO 2 (FM30 ONLY) SpO 2 Alarm Specifications Range Adjustment Delay SpO % 1% steps (0, 1, 2, Desat 50 low alarm 1% steps 3,... 30) + limit 4 sec Pulse bpm 1 bpm steps max. (30 40 bpm) 14 sec 5 bpm steps ( bpm) Tachycardia Difference to 5 bpm steps max. high limit 14 sec 0 50 bpm Clamping at 5 bpm steps bpm Bradycardia Difference to 5 bpm steps max. low limit 14 sec 0 50 bpm Clamping at 5 bpm steps bpm External Power Supply Specifications (FM20/FM30) M8023A External Power Supply Specifications Power Specifications Line Voltage V approximately Current A Frequency Hz approximately Indicators AC Power green LED Ingress Protection for External Power Supply (M8023A) IP31 (protected against the ingress of solid foreign objects 2.5 mm in diameter or larger, and the ingress of water when water is dripping vertically) when rested on its rubber feet on a flat, level surface M8023A External Power Supply Specifications IP32 when mounted with the connectors facing downwards Battery Specifications (FM20/FM30) M4605A Battery Specifications Performance Specifications Avalon FM20/30 Battery Operating Time (with new, fully #E25 charged battery) Basic monitoring configuration: >2 hours (Display Brightness: 70%, Recorder: "On" at 3 cm/min, NBP: Auto Mode at 15 min, 2 US Transducers, 1 Toco+ with MECG, 1 Patient Module with DECG) Charge Time When monitor is off: approx. 6 hours When monitor is in use: more than 10 hours (depending on monitor configuration) Recorder Specifications (FM20/FM30) Built-in Thermal Array Fetal Trace Recorder Mechanism Thermal Array Recorder Paper and Printing Type Standard Z-fold paper Standard Speeds (realtime traces) 3 cm/min, 2 cm/min, 1 cm/min ECG Wave Recording (FM30 only. Not realtime.) Emulated 25 mm/s Print speed is variable up to 20 mm/s and depends on the print load Stored Data Recording/Trace Recovery Printout Print speed is variable up to 20 mm/s and depends on the print load Paper Advance Up to 20 mm/s Sensing Optical Reflex Sensor for black page marks 3 cm/min, 2 cm/min, 1 cm/min ± 5 mm/page 8

9 Built-in Thermal Array Fetal Trace Recorder Usable Print 128 mm Width Resolution 8 dots/mm (200 dpi) Time Delay to < 1 cm/min see trace on paper Trace Separation Twin Standard FHR2 +20 bpm Offset for FHR Classic FHR1 +20 bpm (Ultrasound/ Triplet Standard FHR2 +20 bpm DECG) FHR3-20 bpm Classic FHR1 +20 bpm FHR3-20 bpm Ordering Guide and Accessory s (FM20/FM30) You can order the Avalon FM20/FM30 fetal monitor under the product number M2702A/M2703A. To order, precede the required option number with M2702A (for example, M2702A#B71 adds the noninvasive blood pressure measurement). K options let you modify your order. The following tables give an overview of the monitor s standard capabilities, and what is available as options. Refer to Standard Accessories Included (FM30 only) on page 11 for a list of items shipped as part of the standard configuration. Start-up quantities of fetal supplies are available in five convenient kits. Features listed as options can be added at a later time (see Upgrade s (FM20/FM30) on page 17). Standard Measurements (FM20/FM30) Recommended Accessory FM20 Standard Fetal Measurements Fetal Heart Rate (FHR) via ultrasound Twins monitoring via ultrasound K01 Fetal Movement Profile (FMP) We recommend switching off FMP during labor. Toco MP FM20 Standard Maternal Measurements Maternal Heart Rate via MECG K03 electrodes You can measure MHR using the Toco + transducer Order M2735A separately (option K03) ADDITIONAL STANDARDS MEASUREMENTS (FM30 ONLY) Recommended Accessory FM30 Standard Fetal Measurements Toco MP K10 DFHR via Direct ECG (DECG) including DECG waveform Intrauterine Pressure (IUP) K03 FM30 Standard Maternal Measurements Maternal ECG and Heart Rate via K03 MECG electrodes, including MECG waveform al Measurements (FM20/FM30) Recommended Required Accessory (s) NST Report Capability Non-Stress Test reporting C71 n/a al Fetal Measurements Triple FHR via ultrasound C73 K02 al Maternal Measurements Noninvasive Blood Pressure (NIBP) with Pulse Rate Pulse Oximetry (maternal SpO 2 ) together with NBP with Pulse Rate (FM30 only) al Interfaces (FM20/FM30) Dual PS/2 Interface for keyboard and mouse connection System Interface (1 x RS232 port and 1 x LAN port) Dual MIB/RS232 interface board (for Data Export functionality and for maternal infrared temperature measurement) Quad. USB Interface (Keyboard, Mouse, Bar Code Reader) B71 K31 B73 K31 + K91 Recommended Required Accessory J22 M8024A #A01 J70 J13 J25 9

10 Recommended Required Cable and Transducer s Accessory K04 Order the Remote Event Marker ( ) Flexible Nurse Call Relay J30 Interface Avalon CL Transducer System Avalon CL Transducer System Product using option K04 K30 Avalon CTS Interface Cable M K31 Order Antimicrobial NBP Cuff assortment kit with 3 m (10 ft) connection tubing (M1599B) using option K31: M1573A; M1574A; M1575A ACCESSORIES (FM30 ONLY) CL Base Station CL Toco + MP Transducer Tympanic Temperature Module CL Ultrasound Transducer CL ECG/IUP Transducer Mounting brackets Tympanic Temperature Module Tympanic Temperature Module, including: a base station for mounting on a table, wall, or a roll stand A starter pack of 96 probe covers Adding a 1.5 m, RS232 connection cable for use with the fetal monitors Adding a 3.0 m, RS232 connection cable for use with the fetal monitors order directly from GCX Product #A #A02 Cable and Transducer s K10 Toco MP transducer and Patient Module (instead of Toco+ transducer) as standard K11 Toco+ Transducer (replaces K10) Paper Scaling s (FM20/FM30) P bpm paper scaling P bpm paper scaling Transport s (Battery and External Power Supply FM20/ FM30) E25 Battery (M4605A), external power supply (M8023A #E25) and MSL cable (1 m) Fetal Supplies Starter Kits (FM20/FM30) Accessories (FM20/FM30) Cable and Transducer s K01 The monitor comes with one ultrasound transducer. To add a second M2736A ultrasound transducer, order option K01 K02 The monitor comes with one ultrasound transducer. To add two additional M2736A ultrasound transducers, order option K02 (only in conjunction with C73) K03 Order ECG Patient Module M2738A, using option K03 (includes MECG adapter cable M1363A) Kit Standard Antepartum Kit (North America) Standard Antepartum Kit (Europe, Latin America, Asia) Standard Antepartum Kit (Japan) Contents Paper (30 240), belts, gel, belts buttons, belt clips Paper (50 210), belts, gel, belts buttons, belt clips Paper (50 210), belts, gel, belts buttons, belt clips 10

11 FETAL SUPPLIES STARTER KITS (FM30 ONLY) Fetal Accessories (FM20/FM30) Kit Contents Intrapartum DECG Kit Fetal scalp (single spiral) electrodes, fetal adhesive pad electrodes Intrapartum DECG Kit Fetal scalp (double spiral) electrodes, fetal Europe only, not for USA adhesive pad electrodes Standard Accessories Included (FM20/FM30) Quantity Ultrasound transducer 1 Toco MP transducer 1 Butterfly Belt Clips 1 per Transducer Fetal paper pack (country-specific, installed) 1 Power cable 1 Instructions for Use 1 Documentation DVD (includes Service Guide and 1 Instructions for Use) Fetal Accessories FETAL ACCESSORIES (FM30 ONLY) Part Belt (reusable, gray, water resistant) 32 mm wide, 15 m roll M4601A 1 60 mm wide, 5 belts M4602A 60 mm wide, 15 m roll M4603A 50 mm wide, 5 belts M1562B Belt (disposable, yellow, water resistant) 60 mm wide, pack of 100 M2208A Ultrasound Gel 12 Bottles 40483A 5 liter refill (with dispenser) for 40483A Shelf life: 24 months maximum Belt Buttons and Belt Clip Belt buttons, pack of 10 1 Note: 32 mm belts for use with M2738A Patient Module only 40483B M1569A Butterfly belt clip (pack of 6) Telemetry Interface Cable Telemetry interface cable Avalon CTS Cable M External Marker STANDARD ACCESSORIES INCLUDED (FM30 ONLY) Quantity Patient module for DECG, MECG, or IUP 1 monitoring (K10) DECG adapter cable MECG adapter cable M1363A 1 Transducers (FM30/FM20) Supported Transducers Part Ultrasound transducer M2736A Toco MP transducer for monitoring external Toco M2734B and maternal pulse TRANSDUCER (FM30 ONLY) Part Supported Transducers Toco + transducer for monitoring Toco, DECG, M2735A MECG, or IUP (K11) Patient Module for monitoring maternal heart M2738A rate, DECG or IUP Fetal Accessories Part DECG Accessories: New Philips DECG Solution DECG reusable leg plate adapter cable (with flushing port) DECG leg attachment electrode for DECG leg plate adapter cable DECG fetal scalp electrode: single spiral, worldwide availability DECG fetal scalp electrode: double spiral, Europe only. Not for USA DECG Accessories: QwikConnect Plus Solution DECG reusable leg plate adapter cable M1362B (QwikConnect Plus ) DECG leg attachment electrode for DECG leg M1349A plate adapter cable DECG fetal scalp electrode: single spiral, 15133E worldwide availability DECG fetal scalp electrode: double spiral, 15133D Europe only. Not for USA Koala IUP Accessories Disposable Koala IUP catheter M1333A Reusable Koala IUP adapter cable

12 MECG ACCESSORIES (FM30 ONLY) Maternal Heart Rate Accessories MECG adapter cable Foam MECG electrodes, snap-fit, for MECG adapter cable Part M1363A 40493D/E Recorder Paper (FM20/FM30) Supplied in cases of 40 packs. Each pack has 150 numbered pages Product No. Geography FHR Scale Grid Color Scale Units High-lighted 3cm Lines? M1910A USA/Canada and Asia Red/Orange mmhg Yes M1911A Europe/Japan Green mmhg and kpa No M1913A Japan Green mmhg Yes M1913J Japan Green* mmhg Yes *Bradycardia and tachycardia alarm ranges are shaded. Noninvasive Blood Pressure Accessories (FM20/FM30) Multi-Patient Comfort Cuffs and Disposable Cuffs Maternal Patient Bladder Disposable cuff Reusable cuff Limb Circumference Category Width Part No. Part No. Tubing Adult (Thigh) cm 20.0 cm M1879A M1576A M1598B (1.5 m) or Large Adult cm 16.0 cm M1878A M1575A M1599B (3.0 m) Adult cm 13.0 cm M1877A M1574A Small Adult cm 10.5 cm M1876A M1573A Cuff kit of 4 adult sizes M1578A 12

13 Antimicrobial Coated Reusable Cuffs Maternal Patient Category (color) Limb Circumference Bladder Width Part No. Tubing Adult Thigh (gray) cm 21.0 cm M4559B M1598B (1.5 m) or Adult Thigh (gray) cm 21.0 cm M4559B5 M1599B (3.0 m) pack of 5 cuffs Large Adult X-Long (burgundy) cm 17.0 cm M4558B Large Adult X-Long (burgundy) cm 17.0 cm M4558B5 pack of 5 cuffs Large Adult (burgundy) cm 17.0 cm M4557B Large Adult (burgundy) cm 17.0 cm M4557B5 pack of 5 cuffs Adult X-Long (navy blue) cm 13.5 cm M4556B Adult X-Long (navy blue) cm 13.5 cm M4556B5 pack of 5 cuffs Adult (navy blue) cm 13.5 cm M4555B Adult (navy blue) cm 13.5 cm M4555B5 pack of 5 cuffs Small Adult (royal blue) cm 10.6 cm M4554B Small Adult (royal blue) cm 10.6 cm M4554B5 pack of 5 cuffs Cuff kits containing one small adult, one adult, one large adult and one thigh cuff Cuff kits containing one small adult, one adult, one adult X-long, one large adult, one large adult X-long and one thigh cuff Soft Single Patient Single-Hose Disposable Cuffs Patient Category Limb Circumference (cm) Bladder Width (cm) Part No. Tubing Adult (Thigh) M4579B M1598B (1.5 m) Large Adult X-Long M4578B or Large Adult M4577B M1599B (3.0 m) Adult X-Long M4576B Adult M4575B Small Adult M4574B 13

14 SpO 2 Accessories (FM30 only) All listed sensors operate without risk of exceeding 41 C on the skin if the initial skin temperature is below 37 C. Philips Reusable Sensors Comments Product Adult sensor (2.0 m cable), for patients over 50 kg. Any finger, No adapter cable required. M1191B except thumb. M1191A with longer cable (3.0 m) M1191BL Small adult, pediatric sensor (1.5 m cable) for patients M1192A between 15 kg and 50 kg. Any finger except thumb.. Ear sensor (1.5 m cable) for patients more than 40 kg. M1194A. Adult clip sensor (3 m cable) for patients over 40 kg. Any M1196A finger except thumb. Adult clip sensor (2 m cable) for patients over 40 kg. Any M1196S finger except thumb. Adult sensor (0.45 m cable), for patients over 50 kg. Any Requires M1943A (1.0 m) or M1943AL M1191T finger except thumb. (3.0 m) adapter cable. Small adult, pediatric sensor (0.45 m cable) for patients M1192T between 15 kg and 50 kg. Any finger except thumb.. Adult clip sensor (0.9 m cable) for patients over 40 kg. Any M1196T finger except thumb. Special Edition (SE) No adapter cable required. M1191ANL Adult sensor (3 m cable), for patients over 50 kg. Any finger except thumb. Special Edition (SE) SE sensors work with FM30/40/50, as well as with OxiMax-compatible SpO 2 versions M1192AN Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg and 50 kg. Any finger except thumb.. of other Philips monitors. Special Edition (SE) Ear sensor (1.5 m cable) for patients more than 40 kg. M1194AN Philips Disposable Sensors Not available in the USA: Comments Product Identical to OxiMax MAX-A Requires M1943A (1.0 m) or M1943AL (3.0 m) M1904B Identical to OxiMax MAX-P adapter cable M1903B Identical to OxiMax MAX-N M1901B 14

15 Available worldwide: Comments Product Adult/Pediatric finger sensor (0.45 m cable) Requires M1943A (1.0 m) or M1943AL (3.0 m) M1131A. adapter cable Adult/Pediatric finger sensor (0.9 m cable) for M1133A patients >40 kg. Any finger except thumb.. Adult/Pediatric finger sensor (0.9 m cable) for M1134A patients >40 kg. Any finger except thumb. Adhesive-free. Nellcor Sensors Nellcor sensors must be ordered from Nellcor/Covidien. Product Comments OxiMax MAX-A Adult finger sensor (patient size >30 kg) Requires M1943A (1.0 m) or OxiMax MAX-AL OxiMax MAX-A with long cable M1943AL (3.0 m) adapter OxiMax MAX-P Pediatric foot/hand sensor (patient size kg). cable. OxiMax MAX-N Adult finger or neonatal foot/hand sensor (patient size >40 kg or <3 kg). Oxisensor II D-25 Adult sensor (patient size >30 kg) Requires M1943A (1.0 m) or Oxisensor II D-20 Pediatric sensor (patient size kg). M1943AL (3.0 m) adapter cable. Oxisensor II N-25 Neonatal/Adult sensor (patient size <3 kg or >40 kg) Use only on adult patients with FM30/40/50. OxiCliq A See OxiMax MAX-A Requires M1943A (1.0 m) or OxiCliq P See OxiMax MAX-P. M1943AL (3.0 m) adapter cable together with OC-3 OxiCliq N See OxiMax MAX-N adapter cable. Masimo LNOP Reusable Sensors Product Philips Part LNOP DC-I Adult Finger Sensor (>30 kg) LNOP DC-IP Pediatric Finger Sensor (10 50 kg) LNOP YI Multi-Site Sensor (>1 kg) n/a LNOP TC-I Ear Sensor (>30 kg) For use with this sensor the adapter cable LNOP MP12 (M ) is needed. 15

16 Masimo LNCS Reusable Sensors Product Philips Part LNCS DC-I Adult Finger Sensor (>30 kg) LNCS DC-IP Pediatric Finger Sensor (10 50 kg) LNCS TC-I Ear Sensor (>30 kg) For use with this sensor the adapter cable LNC MP10 ( ) is needed. Masimo LNOP Disposable Adhesive Sensors Product Philips Part LNOP Adt Adult Sensor (>30 kg) LNOP Adtx Adult Sensor (>30 kg) n/a LNOP Pdt Pediatric Sensor (10 50 kg) LNOP Pdtx Pediatric Sensor (10 50 kg) n/a LNOP Neo-L Neonatal (<3 kg) or Adult adhesive Sensor (>40 kg) Masimo LNCS Disposable Adhesive Sensors Product Name Philips Part LNCS Adtx Adult Sensor (>30 kg) LNCS Pdtx Pediatric Finger Sensor (10 50 kg) LNCS Neo-L Neonatal Foot Sensor (<3 kg) or Adult Finger Sensor (>40 kg) Input Devices (FM20/FM30) Slimline keyboard with integrated trackball M8024A #A01 (includes spill cover) Optical mouse M8024A #B01 Trackball M8024A #C01 Wireless trackball M8024A #C02 Hand-Track M8024A #C03 16

17 Mounting Hardware (FM20/FM30) Mounts, Carts, and Rollstands M2740A #A01 M2740A #A05 M2740A #B01 M2740A #C02 Flush Wall Mount for a flat Wall Mount (Arm) Bed Hanger Cart with fixed angle mount and wall mounting two drawers M2740A #R01 M2740A #U01 M2740A #W01 Rollstand with tray Mounting Kit for Avalon CTS for use with M2740A #C02 Wall Channel required for wall mounts A01 and A05 Upgrade s (FM20/FM30) Upgrade options are prefixed with M2702AU/ M270203AU. For example, to add a system interface upgrade, order M2702AU J70. Upgrade s Adds B71 Noninvasive Blood Pressure, no supplies included B72 Pulse oximetry (SpO 2 ), no supplies included B73 Connector cover for NBP and SpO 2 connectors C71 NST Report Capability C73 Triplets monitoring capability CL2 Support for cableless maternal measurements (IntelliVue CL NBP and CL SpO 2 ). Not available with option E25. E25 Battery upgrade for monitors with Rev. G software or higher Upgrade s Adds J13 Dual MIB/RS232 Interface for Data Export functionality, and for maternal infrared temperature measurement J22 Dual PS/2 Interface for connecting a keyboard and mouse J25 Quad. USB Interface (Keyboard, Mouse, Bar Code Reader) J30 Flexible Nurse Call Relay Interface J70 System Interface: 1 x RS232 port and 1 x LAN port K30 Avalon CTS Interface Cable M SJ3 Rel. J.3 Software Upgrade 17

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20 Philips Healthcare is part of Royal Philips How to reach us fax: Avalon FM20/M2702A and FM30/M2703A comply with the requirements of the Council Directive 93/42/EEC of 14 June 1993 (Medical Device Directive). Asia Europe, Middle East, Africa Latin America North America (toll free, US only) Please visit Koninklijke Philips N.V. All rights are reserved. Philips Healthcare reserves the right to make changes in specifications and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication. Printed in The Netherlands * APR 2014