Philips M1026B User manual
M1026B Anesthetic Gas Module
Service Guide
Anesthetic Gas Module
M1026B
Patient Monitoring
Part Number M1026-9020A
Reordering Number: 453563499691
*M1026-9020A*
S PHI
1Table of Contents
1 Introduction 7
Description 7
Physical Specifications 7
Environmental Specifications 8
Performance Specifications 8
CO2 Measurement 8
AWR R d eri ved fro m C O2 Wav ef o rm 9
N2O Measurement 9
O2 Measurement 9
Anesthetic Agent Measurement 9
Alarm Ranges 9
Alarm Delay 10
Apnea Alarm 10
INOP Alarms 10
General Measurement Principles 11
Theory of Operation 11
Main PC Board 12
Power Supply 12
Pneumatic System 12
Pump 13
Water trap 14
Sample Flow Through the Pneumatic Path 14
O2 Sensor 15
Specifications 15
Measurement Principle 15
The DIR Head Assembly 17
2 Installation and Patient Safety 19
Physical Installation 19
Environment 19
Making Connections to the AGM 20
Connections to the Sample Gas Exhaust 21
Returning the Gas Sample 21
Setting Up the Gas Return 21
Removing the Gas Sample 22
Setup and Configuration Procedures 22
Altitude Configuration 22
Connect Sample Input Tubing 23
Post-Installation Checks 23
3
Safety Requirements Compliance and Considerations 23
Explanation of Symbols Used 23
Power Supply Requirements 24
Grounding the System 24
Equipotential Grounding 24
Combining Equipment 25
3 Checking and Calibrating the Anesthetic Gas Module 27
Access Service Functions of the M1026B Anesthetic Gas Module 27
When and how to check the Philips M1026B Anesthetic Gas Module 27
Equipment required for checking 28
Checks and adjustments 28
Pneumatic Check 28
Leak Check 31
Zero Calibration 34
Span Check 36
Disposal of Empty Gas Cylinder 40
Flowrate Check 41
Total Flowrate Check 41
Flow Calibration 42
4 Maintaining the Anesthetic Gas Module 47
Preventive Maintenance (PM) Tasks 47
Cleaning 48
Replace PM Parts 48
Replacing the Pump Oulet Filter and the Bacterial Filters 48
Replacing the Fan Filter 49
Replacing the Watertrap Manifold Seals 49
Test and Inspection Matrix 51
When to Perform Test Blocks 53
Safety Tests 53
5 Troubleshooting the Anesthetic Gas Module 57
INOPs 58
Troubleshooting 60
Troubleshooting Table: 61
6 Repairing the Anesthetic Gas Module 63
Introduction 63
Event Log 64
Removing the Top Cover 64
Replacing the Power Supply 68
Replacing the O2 Cell 70
Replacing the Pneumatic Assembly 71
4
7 Parts List 75
Service Equipment 77
5
6
This chapter contains the following information on the M1026B Anesthetic Gas Module:
• A description of the Module, including its physical, environmental and performance specifications
• A general explanation of the measurement principles that the Module uses to measure gas
concentrations
• The theory of operation of the Module, its components and how they work.
Description
The Philips M1026B Anesthetic Gas Module works together with the IntelliVue MP40/50/60/70/90
and the ACMS and V24/26 patient monitors through an RS232 serial interface. It measures the airway
gases of ventilated patients who are under general gas anesthesia, or emerging from it.
1
1Introduction
The module produces graphical wave data, and inspired and end-tidal numeric data for the following
gases:
•CO
•N
• One volatile anesthetic agent
•O
It also generates a numeric for the patient’s airway respiration rate (AWRR).
The Agent Identification feature identifies which anesthetic agent is being used.
2
O
2
2
Physical Specifications
Size (H x W x D):
Weig ht: 6.3 kg (13.9 lb)
90mm x 370mm x 467mm (3.54 x 14.6 x 18.4 in)
7
1Introduction Environmental Specifications
Environmental Specifications
Operating Temperature: 10 to 40°C (50 to 104°F)
Storage Temperature: -20 to 70°C (-4 to 158°F)
Humidity Limit (Operating): up to 95% RH max @ 40 °C (104 °F).
non-condensing
Humidity Limit (Storage): up to 95% RH max @ 70°C (158 °F).
non-condensing
Altitude Range (Operating): -381 to 3048m (-1,250 to 10,000 ft)
Altitude Range (Storage): -305 to 5,486m (-1,000 to 18,000 ft)
Warm-up Time: Full Accuracy after selftest is finished (max. 2 min)
Performance Specifications
All Performance and accuracy specifications are valid based on gas sample tubing M1658A, including
watertrap M1657B, and airway adapter 13902A.
Humidity Correction: For CO
Wet: p [mmHg] = c [Vol%] * (p_abs - p_H
Dry: p [mmHg] = c [Vol%] * p_abs /100
Where p = partial pressure, c = gas concentration, p_abs = pressure in breathing circuit, p_H
mmHg, partial pressure of water vapor of exhaled gas (37
For all other gases the readings are always given as dry values.
Sample Flow Rate: 150 ml/min.
Sample Delay Time: All measurements and alarms are subject to a delay of 3 seconds.
Total System Response Time = the sum of the delay time and the rise time.
CO2 Measurement
Range: 0 to 76 mmHg
Accuracy: ± 1.5 mmHg (0 - 30 mmHg)
Resolution: 1 mmHg
Rise-time: 410 msec typical
the humidity correction can be set to “wet” or “dry”.
2
O)/100
2
o
C, 100% rh).
± 5 rel. % (30 - 76 mmHg)
O = 47
2
The total system response time is the sum of the sample delay time (3 seconds) and the rise time (410
msec typical)
8
Performance Specifications 1Introduction
AWRR derived from CO2 Waveform
Range: 0 to 60 rpm
Accuracy: ± 2 rpm
Resolution: 1 rpm
Detection Criteria: 6 mmHg variation in CO
N
O Measurement
2
Range: 0 to 85 vol%
Accuracy: ± 1.5 vol% + 5% relative
Resolution: 1 vol%
Rise-time: 510 msec typical
O
Measurement
2
Range: 0 to 100vol%
Accuracy: ± 3 vol%
Resolution: 1 vol%
Rise-time: 640 msec typical
Anesthetic Agent Measurement
2
Agent Range (vol%) Accuracy Resolution Rise Time
Halothane 0 - 7.5 ± (0.1 vol% + 4.0% relative) 0.05 < 900
Enflurane 0 - 7.5 ± (0.1 vol% + 4.0% relative) 0.05 < 620
Isoflurane 0 - 7.5 ± (0.1 vol% + 4.0% relative) 0.05 < 610
Sevoflurane 0 - 9.0 ± (0.1 vol% + 4.0% relative) 0.05 < 570
Desflurane 0 - 20.0 ± (0 . 1 v o l % + 4 . 0 % r e l a t i v e 0 . 0 5 ( 0 - 1 0 )
Alarm Ranges
AWRR 10 - 60 rpm 0 - 59 rpm
ETCO
0.1 (10.1-20)
Agent High Range Low Range
2
20 - 76 mmHg 10 - 75 mmHg
< 540
9
1Introduction Performance Specifications
Agent High Range Low Range
IMCO
inN2O0 - 82 vol% none
inO
2
et SEV 0.1 - 9.0 vol% 0.0 - 8.9 vol%
in SEV 0.1 - 9.0 vol% 0.0 - 8.9 vol%
et DES 0.2 - 20.0 vol% 0.0 - 19.8 vol%
in DES 0.2 - 20.0 vol% 0.0 - 19.8 vol%
Halothane, Enflurane, Isoflurane
et 0.1 - 7.5 vol% 0.0 - 7.4 vol%
in 0.1 - 7.5 vol% 0.0 - 7.4 vol%
Alarm Delay
10 seconds if no automatic zero calibration occurs within that time.
Apnea Alarm
Delay Range: 10 - 40 seconds
Criterion No detected breath within the adjusted delay time
2
2 - 20 mmHg none
19-100 vol% 18 - 99 vol%
Alarm: Within 2 seconds after this criterion is met, if no automatic zero
INOP Alarms
INOP alarms are triggered if:
• The Philips M1026B Anesthetic Gas Module is disconnected or switched off.
• The equipment malfunctions.
• Zero calibration has failed.
• Zero calibration is in progress.
• The gas sample tube is occluded, or the water trap is full.
• The Philips M1026B Anesthetic Gas Module is unable to measure.
• Gas contaminant is detected.
• Agent mixture detected.
• Anesthetic agent detected but not selected.
• The module is in self-test.
• No breath detected.
occurs
10
General Measurement Principles 1Introduction
General Measurement Principles
The M1026B Anesthetic Gas Module uses a technique called Dispersive Infrared (DIR) absorption to
measure the concentration of certain gases. The gases measured by the M1026B Anesthetic Gas
Module (except oxygen) absorb infrared (IR) light and each gas has its own absorption characteristic.
The gas is transported into a sample cell. A diffraction grating is used to scan the relevant wavelength
range of the IR light that passes through the sample cell. The higher the concentration of gas the more
IR light is absorbed, and from the amount of IR light measured, the concentration of gas present can
be calculated.
Individual gases have an individual spectral fingerprint. A mathematical algorithm is used to analyze
the spectrum and to identify and quantify the anesthetic agents in the gas.
Oxygen is measured by an additional sensor in the M1026B Anesthetic Gas Module using its
paramagnetic properties.
Theory of Operation
Figure 1 shows the functional blocks within the Philips M1026B Anesthetic Gas Module.
Figure 1 Anesthetic Gas Module Functional Block Diagram
The main components of the Philips M1026B Anesthetic Gas Module are:
• Main PC Board.
• Power Supply.
•Pneumatic Assembly.
Sensor.
•O
2
11
1Introduction Theory of Operation
• DIR optics.
Main PC Board
The electronics subsystem, with memory (FLASH & RAM), multiplexers, A-D converter, and power
line supervision, is responsible for the following functions:
• The acquisition and processing of data from, and control of, the anesthesia gas measurement
analyzer.
• The acquisition and processing of data from the oxygen analyzer.
• Controlling the pneumatic system.
• Controlling the communications between the M1026B and the host monitoring system.
The M1026B electronics subsystem has one communications channel, connected to an external RS232
port.
The M1026B functionality is controlled by Flash Memory resident software.
Power Supply
The input voltage is 100V - 240V. The output voltages are ±12V and +3.3V.
Pneumatic System
The main parts of the pneumatic system are:
• Watertrap.
• Pneumatics assembly including:
– pump outlet filter
– two flow restrictors
– four bacterial filters
– three solenoid valves
– dampening volumes
•Pump
12
Theory of Operation 1Introduction
Figure 2 Pneumatic System
Pump
The pneumatic system works in the following way:
1 Eliminates residual water and fluids from patient sample gas using the watertrap.
2 Splits the patient’s sample gas flow (150ml/min) into the measurement path (120ml/min) and
drainage path (30ml/min).
3 Passes the patient’s sample gas in the measurement path at 120ml/min through the measurement
bench (O2 analyzer, DIR Head).
4 Delivers zero calibration gas to the sample cells for the periodic zeroing.
5 Exhausts the patient’s sample gas, the zero calibration gas, and the span calibration gas.
6 Monitors for an occlusion in the sampling pneumatics.
The software-controlled pump generates the flow through the system and pulls the gas from the airway
adapter through the measurement subsystems to the exhaust outlet. It also delivers the zero calibration
gas to the sample cells of the measurement subsystems for the periodic zero procedures and it exhausts
the patient’s sample gas, the zero calibration and field calibration gases.
The flow-rate control logic drives the pump as hard as necessary to maintain the selected flow rate. A
partial occlusion or an inefficient pump results in the pump being driven harder. A serious occlusion
results in the pump being driven at or near its maximum load. This triggers a logic, which then reports
an occlusion.
13
1Introduction Theory of Operation
Watertrap
Figure 3 Watertrap
The watertrap consists of two water separation filters, two water fuses and a water reservoir. The gas
sample coming from the patient may contain fluids which are separated from the gas at the first water
separation filter. The gas is then split into two paths, the “measurement” path with the main part of the
total gas flow (including water vapor) continuing on the “dry” side of the separation filter and the
“drainage” path (containing any liquid droplets) with the smaller amount of the total flow continuing
on the “wet” side of this filter through the water reservoir. At the pump both gas paths are recombined.
The watertrap proper includes “water fuses” in both the “measurement” and the “drainage” paths,
consisting of a material that swells when getting wet (when the reservoir is full or when fluid penetrates
the separation filter and enters the “measurement” path) and blocks the respective path at the inlet of
the unit. Once the “water fuses” are blown, any passage of fluid is blocked and the gas flow resistance
increases so that an occlusion is detected.
Sample Flow Through the Pneumatic Path
The drainage path serves to withdraw fluid separated at the first water separation filter from the gas
sample into the watertrap reservoir.The drainage path leads into the large watertrap reservoir where all
liquid water and other fluids are collected. When the drainage path leaves the watertrap through a
water separation filter and a through a water fuse it leads through a bacterial protection filter and flow
restrictor directly to the pump. This flow restrictor determines the percentage distribution between
drainage and measurement path flow.
14
Theory of Operation 1Introduction
The measurement path leads through the first water separation filter and through a water fuse on into
the measurement system. The patient sample gas (on the measurement path) then flows through a
bacterial protection filter to solenoid valve #0. Room air for the zero calibration is alternatively input
(via a filter) to this solenoid valve. The solenoid valve switches between the two gases depending on the
current mode of operation - normal measurement or zero calibration.
The patient sample gas or zero calibration gas then flows through the measurement subassemblies:
– the DIR Measurement Assembly (for measurement of anesthetic agent, CO
–the O
From here it is passed to the flow sensor which consists of a differential pressure transducer and a flow
restrictor. The flow sensor determines, stabilizes and limits the flow rate of the sampled gas.
Then the patient sample gas or zero calibration gas flows to the pump. Before reaching solenoid valve
#2 and the pump, it joins the drainage path again.
After the gas has passed through solenoid valve #1 it is routed through a filter to the Sample Gas
output. Alternatively, the zero gas is output to the zero gas outlet port by this solenoid valve.
2
cell
O2 Sensor
Specifications
Weight 150 g
Size (HxWxD) 65 x 30 x 65 mm
Measurement Principle
The O2 sensor uses a fast O2 measurement technique that utilizes O2 paramagnetic properties.
and N2O)
2
Two sealed spheres are filled with N
mirror is mounted centrally on the suspension and light is shone onto the mirror. The reflected light is
directed onto a pair of photocells. Oxygen attracted into the magnetic field displaces the nitrogen filled
spheres, causing the suspension to rotate. The photocells detect the movement and generate a signal.
and mounted on a rotating suspension within a magnetic field. A
2
15
1Introduction Theory of Operation
The signal generated by the photocells is passed to a feedback system which passes a current around a
wire mounted on the suspension. This causes a motor effect which keeps the suspension in its original
position. The current flowing around the wire is directly proportional to the concentration of oxygen
within the gas mixture.
16
Theory of Operation 1Introduction
The DIR Head Assembly
Figure 4 Anesthetic Gas Module DIR Head Assembly
The DIR head functions as follows:
The infrared light source is a tungsten filament lamp.
The Anesthetic Gas Module sample cell is constructed of a glass tube with a highly reflective gold
coated internal surface that serves as a light pipe. The sample cell length is designed to provide an
adequate absorption length to obtain the desired signal-to-noise ratio for the weakest anticipated
absorption. Sapphire serves as the sample cell window material for the two ends of the sample cell.
The gas sample to be analyzed enters the sample cell through the gas inlet and leaves it through the gas
outlet. While in the cell, the gas sample is penetrated by light from the infrared light (IR) source. This
light is dispersed via a single diffraction grating. The attached brushless DC rotary actuator working in
tune with an encoding mechanism ensures that the grating is always in the correct position. The
dispersed light is reflected by a mirror and lastly hits a dual filter/detector package.
Software then takes the data from the scan of the dispersed component wavelengths to produce a
characteristic curve, its shape determined by the relative concentrations of different gases in the sample.
A thermistor in the outlet gas stream measures the sample gas temperature. A transducer measures
sample gas pressure. Knowledge of sample gas pressure and sample gas temperature is vital for accurate
gas measurements.
Zero calibration capability is provided to maintain long-term, stable gas concentration measurement.
17
1Introduction Theory of Operation
18
2Installation and Patient Safety
This chapter describes how to install the Philips M1026B Anesthetic Gas Module. It details the
operating environment required by the Philips M1026B Anesthetic Gas Module as well as instructions
on how to affix the local language labels and physically connect it to the monitor. Next, the patient
safety information is detailed. Finally, this chapter describes the software setup required and any postinstallation checks that have to be performed before using the Philips M1026B Anesthetic Gas Module
together with a reminder of the preventive maintenance (PM) checks and their frequencies.
Physical Installation
This section describes the operating and storage environment for the Philips M1026B Anesthetic Gas
Module, affixing the local-language labels, connecting to the monitor, and fitting the gas exhaust
return system.
2
CAUTION The Philips M1026B Anesthetic Gas Module must be positioned horizontally on a level surface. To
avoid condensed water collecting in the patient sample tube, it is recommended that the Philips
M1026B Anesthetic Gas Module is positioned at or above patient level, wherever possible.
Environment
WARNING Possible explosion hazard if used in the presence of flammable anesthetics.
The environment where the Philips M1026B Anesthetic Gas Module is used should be free from
vibration, dust, corrosive or explosive gases, and extremes of temperature and humidity.
For a cabinet mounted installation with the monitor, allow sufficient room at the front for operation
and sufficient room at the rear for servicing with the cabinet access door open.
The Philips M1026B Anesthetic Gas Module operates within specifications at ambient temperatures
between 15°C and 40°C, 2 minutes after switching it on.
Ambient temperatures that exceed these limits could affect the accuracy of this instrument and cause
damage to the components and circuits. Allow at least 2 inches (5cm) clearance around the instruments
for proper air circulation.
CAUTION If the Philips M1026B Anesthetic Gas Module has been stored at temperatures below freezing, it needs
a minimum of 4 hours at room temperature to warm up before any connections are made to it.
19
2 Installation and Patient Safety Making Connections to the AGM
Make sure that the Philips M1026B Anesthetic Gas Module is free of condensation before operation.
Condensation can form when equipment is moved from one building to another, thus being exposed
to moisture and differences in temperature.
Making Connections to the AGM
All connections to the AGM are made on its rear panel. Refer to Figure 5.
6
5
Figure 5 The Rear Panel
1 Local power connector; this is a 3-pin connector, used to connect the AGM to the local line voltage
supply.
The Anesthetic Gas Module can be operated from an ac power source of 100 - 240 V ± 10%, 50/60
Hz. The adjustment is made automatically by the power supply inside the module.
2 RS232 Connector (RS232 Interface); this is a 25-pin “D” type connector, used to connect the
AGM to the monitor.
The connection to an IntelliVue patient monitor can be made with the following cables:
– M1026B#K11 1 m (M1026-61001)
– M1026B#K12 3 m (M1026-61002)
– M1026-61003 10 m
The connection to an ACMS patient monitor can be made with the following cables:
– M1181A#A52 or M1026B#K01 1 m (M1181-61658)
– M1181A#A51 3 m (M1181-61632)
– M1181A#A5A 10 m (M1181-61630)
The connection to a V24/V26 patient monitor can be made with the following cable:
– M1204-60192 (1.2 m)
7
2
4
1
3
20
Connections to the Sample Gas Exhaust 2 Installation and Patient Safety
3
Equipotential Grounding Terminal; this is used to connect the AGM to the hospital’s grounding
system.
4 Line protection fuses, T1 A H 250V.
5 Anesthetic gas exhaust. If N
pollution of the operating room should be prevented. Once the gas sample has passed through the
AGM, it should either be returned to or removed from the anesthesia circuit.
6 Zero Gas Exhaust
7 Fan Filter
O and/or other inhalation anesthetics are used during anesthesia,
2
Connections to the Sample Gas Exhaust
Returning the Gas Sample
You will need the following equipment to return the gas sample to the anesthesia circuit:
Equipment Part Number Comments
Gas Exhaust Return Line M1655A Tub in g i n c l ud e s t w o pa r t s :
Tube A = 50cm long
Tube B = 3m long
Gas Exhaust Return Filter M1656A Single patient use only
NOTE The M1655A may not be available in all countries.
Setting Up the Gas Return
(see diagram Figure 6)
1 Fit the male luer lock connection (2) of the shorter tube, to the female side of the M1656A Gas
Exhaust Return Filter.
2 Fit the female luer lock connection (3) of the longer tube, to the male side of the M1656A Gas
Exhaust Return Filter.
3 Fit the open end (7) of the longer tube to the AGM’s Anesthetic Gas Exhaust.
4 Fit the open end (5) of the shorter tube to the ventilation circuit.
21
2 Installation and Patient Safety Setup and Configuration Procedures
Figure 6 Setting Up the M1655A Gas Exhaust Return Line
1 M1656A Gas Exhaust Return Filter
2 Female luer lock
3 Male luer lock
4 Dampener
5 Shorter tube
6 Connecting tube
7 Longer tube - connected to AGM exhaust port
Removing the Gas Sample
To remove the gas sample from the anesthesia circuit, a scavenging system needs to be connected to the
AGM’s Anesthetic Gas Exhaust. If you intend to use a scavenging system with the AGM, one of the
following parts must also be connected to protect it against malfunction:
1 A ventilator reservoir where the suction pressure does not exceed 0.3-0.4 mmHg or
2 A scavenging interface, properly set and maintained (see scavenging interface manufacturer’s
instructions).
Setup and Configuration Procedures
This section describes final setting up and configuration procedures that must be completed after the
AGM is connected to the monitor and switched on before the AGM is used for monitoring.
Altitude Configuration
The altitude setting for the monitor is important as it is used as a reference to check the AGM ambient
pressure measurement.
22
Post-Installation Checks 2 Installation and Patient Safety
See your monitor service guide for details.
Connect Sample Input Tubing
Connect the sample input tubing to the watertrap at the luer lock connector. For details, refer to the
Instructions for Use.
Post-Installation Checks
See Test and Inspection Matrix for details.
WARNING Do not use the instrument for any monitoring procedure on a patient if you identify anything which
indicates impaired functioning of the instrument.
Safety Requirements Compliance and Considerations
The Philips M1026B Anesthetic Gas Module complies with the following international safety
requirements for medical electrical equipment:
• UL 2601-1
• IEC-60601-1
• CSA C22.2 No. 601.1-M90
• EN 60601-1
• EN 60601-1-2
Explanation of Symbols Used
Attention, consult accompanying documents.
Indicates that the instrument is type CF and is designed to have special
protection against electric shocks (particularly regarding allowable leakage
currents, having an F-Type isolated (Floating) applied part), and is
defibrillator proof.
A gas output.
A gas input.
23
2 Installation and Patient Safety Safety Requirements Compliance and Considerations
Equipotential grounding terminal.
RS232 communication port.
Fuse.
Protective earth ground.
Electrical shock hazard.
The Anesthetic Gas Module is protected against the effects of defibrillation and electrosurgery.
Power Supply Requirements
The system and the Anesthetic Gas Module can both be operated from an AC supply of 100 - 240V
±10%, 50 - 60Hz.
Grounding the System
To protect the patient and hospital personnel, the cabinet of the installed equipment has to be
grounded. The equipment is supplied with a detachable 3-wire cable which grounds the instrument to
the power line ground (protective earth) when plugged into an appropriate 3-wire receptacle. If a 3wire receptacle is not available, consult the hospital electrician.
WARNING Do not use a 3-wire to 2-wire adapter.
Equipotential Grounding
Protection class 1 instruments are already included in the protective grounding (protective earth)
system of the room by way of grounding contacts in the power plug. For internal examinations on the
heart or the brain, Computer Module and Display Module of the System and the Philips M1026B
Anesthetic Gas Module must have separate connections to the equipotential grounding system.
One end of the equipotential grounding cable (potential equalization conductor) is connected to the
equipotential grounding terminal on the instrument’s rear panel and the other end to one point of the
equipotential grounding system. The equipotential grounding system assumes the safety function of
the protective grounding conductor if ever there is a break in the protective grounding system.
24
Examinations in or on the heart (or brain) should only be carried out in rooms designed for medical
use incorporating an equipotential grounding system.
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