Data Sheet
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Philips M1012A
Data Sheet
Cardiac Output Module The M1012A module measures Cardiac Output (C.O.) and Continuous Cardiac Output (CCO). It offers a choice of two measurement methods, the Transpulmonary Thermodilution (PiCCOTM 1) method, and the Right Heart Thermodilution method. Both measurement methods are suitable for adults, pediatric and neonatal patients (above 2 kg) in a range of Critical Care environments. The module can be connected with plug-and-play convenience to these patient monitor families: - V24 (M1205A) - CMS (M1165A/66A/75A and M1175A/76A/ 77A) - IntelliVue (M8005A, M8007A, M8010A). The module sends a thermodilution curve, cardiac output numerics, and cardiac index values to the patient monitor display.
CCO Features • CCO can be measured using the Transpulmonary Thermodilution, or PiCCOTM method. CCO measurement technology using the PiCCOTM method was developed by Philips in cooperation with Pulsion Medical Systems. In Canada, a version of the module without Continuous Cardiac Output functionality is shipped. • Values for Intrathoracic Blood Volume (ITBV) and Extravascular Lung Water (EVLW) can be derived from the Transpulmonary Thermodilution C.O. measurement (not USA). • CCO alarms can be generated from Pulse Contour Analysis when the arterial catheter used for the Transpulmonary Thermodilution is connected to 1. PiCCOTM is a trademark of Pulsion Medical Systems AG.
the module. • Continuous Systemic Vascular Resistance values can be derived from the CCO.
C.O. Features • Absolute and indexed hemodynamic values are shown. • Alarm generation from blood temperature measurement. • Patient isolation by internal optical coupling. • Hard keys on the module for direct access to the most commonly performed functions. • Light indicators identify the module in use during monitoring tasks. • Color-coded patient cable connectors for quick and easy identification. • Compact size due to surface mount technology.
Description
Module Specifications
The M1012A C.O. Module is a Cardiac Output measurement unit that can use the following thermal dilution methods:
Physical Size (HxWxD)
• Transpulmonary Thermodilution (PiCCO Method) • Right Heart Catheter Thermodilution.
99.6 x 36 x 97.5 mm (3.9 x 1.4 x 3.8 inches).
Weight
225 g (7.9 oz.).
It is designed to be used with adult, pediatric or neonatal patients (above 2kg when using the Transpulmonary Thermodilution method), in a range of Critical Care environments.
Complies with UL544, IEC 601-1, CSA C22.2 No. 125. Patient leakage current less than 10 µA at 120 V/ 60 Hz. Protected against damage from defibrillation and electrosurgery. USA Federal Law restricts this device to sale by or on the order of a physician.
The module produces a thermodilution curve and numerics for the cardiac output, cardiac index, blood temperature, and injectate temperature values.
Temperature Range
CCO only
Humidity
Intrathoracic Blood Volume (ITBV) and Extravascular Lung Water (EVLW) (not USA) can be derived from the Transpulmonary Thermodilution (PiCCO) C.O. measurement using an arterial thermodilution catheter placed downstream of the heart, in or near the aorta.
Operating
95% RH max. at 40ºC (104ºF)
Storage
95% RH max. at 65ºC (150ºF)
Using the same arterial catheter, in conjunction with the M1006B invasive pressure modules, it is possible to calculate Continuous Cardiac Output (CCO) values from Pulse Contour Analysis of the pressure measured. Systemic Vascular Resistance (SVR) is continuously calculated with the CCO measurement.
Measurement Specifications
Independent alarms are generated for CCO and Blood Temperature.
C.O. instrument accuracy
+ 3% or 0.1 l/min
C.O. repeatability accuracy
+ 2% or 0.1 l/min
Compatibility
If you use the module in a monitor that does not include the PiCCO functionality (for example a CMS monitor release earlier than C.0, or a V24/ V26 monitor), only the right heart method can be used.
Safety
Operating
0 to 55ºC (32 to 131ºF)
Storage
- 40 to 70ºC (- 40 to 158ºF)
Altitude Range Operating
Up to 4,600m (15,000ft).
Storage
Up to 15,300m (50,000ft).
Cardiac Output (Right Heart) C.O. Range
0.1 to 20.0 l/min
Instrument Specification (measured electronically)
System Specification C.O. instrument accuracy
+ 5%.or 0.2 l/min (<=10 l/min) + 8% (>= 10 l/min)
C.O. repeatability accuracy
+ 3% or 0.1 l/min
Cardiac Output (Transpulmonary) C.O. Range
0.1 to 25.0 l/min
Instrument Specification (measured electronically) C.O. instrument accuracy
+ 4% or 0.15 l/min
C.O. repeatability accuracy
+ 2% or 0.1 l/min
System Specification C.O. instrument accuracy
+ 5% or 0.2 l/min
C.O. repeatability accuracy
+ 3% or 0.1 l/min
Blood Temperature Blood Temperature Range
17 to 43°C
Injectate Temperature Injectate Temperature Range
0 to 27°C
EVLW (not available in the USA) EVLW Range
10 to 5000 ml
Standard Deviation
10% or 1 ml/kg
Ordering Information
ITBV ITBV Range
50 to 6000 ml
Accuracy
+ 10% or 30 ml
Repeatability
+ 5% or 20 ml
CCO CCO Range
0.1 to 25.0 l/min
Standard Deviation
10% or 0.3 l/min
Display Update:
2 seconds nominal
Cardiac Output Alarm Specifications
All accessories for modules are optional. These accessories are designed to have special protection against electric shocks (particularly regarding allowable leakage currents), and are defibrillator proof. Accessories C. O. Interface Cable 2.4 m + 2.4 m cable
M1643A
C.O. Temperature Probes
Tblood Alarms Alarm Limit Range 17 to 43°C Adjustment
Steps of 0.1°C (T > 35 °C) Steps of 0.5°C (T < 35 °C)
Alarm Criterion
8 seconds after the value exceeds the set limit value.
Alarm
within 2 seconds after this criterion is met.
CCO Alarms
PiCCO method: PiCCO inline M1646A temperature probe for warm injectate, Latex free, compatible with housings from PULSION Right Heart method: 0.5m standard inline 23001B injectate temp. probe, compatible with Edwards/Baxter housings Additional Accessories for both methods Set of ice buckets
14455A
Alarm Limit Range 0.1 to 25.0 l/min
Remote handswitch
15244A
Adjustment
Pulsion disposables
Steps of 0.1 l/min (CCO < 10.0 l/min) Steps of 0.5 l/min (CCO > 10.0 l/min)
Alarm Criterion
8 seconds after the value exceeds the set limit value
Alarm
within 2 seconds after this criterion is met
Arterial Catheter 4F, 16 cm, or other PV 2014 compatible catheter as validated by Pulsion L16 PiCCO Pressure Transducer Kits compatible with M1646A
PiCCO monitoring PV 8103 kit, (with M1646A, housing PV 4046) 30cm pressure line PiCCO monitoring PV8115 kit, 150cm pressure line PiCCO monitoring PV8115 kit, (with M1646A CVP housing, PV 4046, and central venous catheter): 150cm pressure line
Pulsion Pressure 30cm pressure line PV 8003 Transducer Kits 100cm pressure line PV 8010 compatible with 150cm pressure line PV 8015 Edwards/Baxter housing (required for measuring CCO) PULSION Pressure Interface Cable for disposable pressure transducer
PMK 206
Documentation
The Instructions for Use for this module is included in the documentation package shipped with the ordered system.
Philips Medical Systems is part of Royal Philips Electronics INTERESTED?
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United States: Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810 (800) 934-7372 Canada: Philips Medical Systems Canada 281 Hillmount Road Markham, ON L6C 2S3 (800) 291-6743 Europe, Middle East and Africa: Philips Medizin Systeme Böblingen GmbH Cardiac and Monitoring Systems Hewlett-Packard Str. 2 71034 Böblingen Germany Fax: (+49) 7031 463 1552
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0366
M1012A complies with the requirements of the Council Directive 93/42/EEC of 14 June 1993 (Medical Device Directive).
© Philips Medizin Systeme Boeblingen GmbH, 2002 All rights are reserved. Reproduction in whole or in part is prohibited without the prior written consent of the copyright holder. Philips Medizin Systeme Boeblingen GmbH reserves the right to make changes in specifications 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. JUN 01, 2002 5990-0584EN