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

Table of Contents

1 Introduction	7
Description	7
Physical Specifications	7
Environmental Specifications	8
Performance Specifications	8
CO2 Measurement	8
AWRR derived from CO2 Waveform	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
Watertrap	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

1

Introduction

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.

The module produces graphical wave data, and inspired and end-tidal numeric data for the following gases:

•CO2

•N2O

•One volatile anesthetic agent

•O2

It also generates a numeric for the patient’s airway respiration rate (AWRR).

The Agent Identification feature identifies which anesthetic agent is being used.

Physical Specifications

Size (H x W x D):	90mm x 370mm x 467mm (3.54 x 14.6 x 18.4 in)
Weight:	6.3 kg (13.9 lb)

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1 Introduction

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 CO2 the humidity correction can be set to “wet” or “dry”.

Wet: p [mmHg] = c [Vol%] * (p_abs - p_H2O)/100

Dry: p [mmHg] = c [Vol%] * p_abs /100

Where p = partial pressure, c = gas concentration, p_abs = pressure in breathing circuit, p_H2O = 47 mmHg, partial pressure of water vapor of exhaled gas (37 oC, 100% rh).

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)
	± 5 rel. % (30 - 76 mmHg)
Resolution:	1 mmHg
Rise-time:	410 msec typical

The total system response time is the sum of the sample delay time (3 seconds) and the rise time (410 msec typical)

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Performance Specifications

1 Introduction

AWRR derived from CO2 Waveform

Range:	0 to 60 rpm
Accuracy:	± 2 rpm
Resolution:	1 rpm
Detection Criteria:	6 mmHg variation in CO2

N2O Measurement

Range:	0 to 85 vol%
Accuracy:	± 1.5 vol% + 5% relative
Resolution:	1 vol%
Rise-time:	510 msec typical

O2 Measurement

	Range:			0 to 100vol%
	Accuracy:			± 3 vol%
	Resolution:			1 vol%
	Rise-time:			640 msec typical
Anesthetic Agent Measurement
	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 vol% + 4.0% relative		0.05(0-10)	< 540
							0.1 (10.1-20)
Alarm Ranges
	Agent				High Range		Low Range
	AWRR			10 - 60 rpm		0 - 59 rpm
	ETCO2			20 - 76 mmHg		10 - 75 mmHg

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1 Introduction

Performance Specifications

Agent		High Range		Low Range
IMCO2	2 - 20 mmHg		none
inN2O	0 - 82 vol%		none
inO2	19-100 vol%		18 - 99 vol%
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
Alarm:	Within 2 seconds after this criterion is met, if no automatic zero
	occurs

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.

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General Measurement Principles

1 Introduction

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.

•O2 Sensor.

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1 Introduction

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

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Theory of Operation

1 Introduction

Figure 2 Pneumatic System

The pneumatic system works in the following way:

1Eliminates residual water and fluids from patient sample gas using the watertrap.

2Splits the patient’s sample gas flow (150ml/min) into the measurement path (120ml/min) and drainage path (30ml/min).

3Passes the patient’s sample gas in the measurement path at 120ml/min through the measurement bench (O2 analyzer, DIR Head).

4Delivers zero calibration gas to the sample cells for the periodic zeroing.

5Exhausts the patient’s sample gas, the zero calibration gas, and the span calibration gas.

6Monitors for an occlusion in the sampling pneumatics.

Pump

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.

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1 Introduction

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.

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Theory of Operation

1 Introduction

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, CO2 and N2O)

–the O2 cell

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.

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.

Two sealed spheres are filled with N2 and mounted on a rotating suspension within a magnetic field. A 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.

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1 Introduction

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.

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Theory of Operation

1 Introduction

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.

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1 Introduction

Theory of Operation

18

2

Installation 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.

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.

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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	7			4	3
					1
	2

Figure 5 The Rear Panel

1Local 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.

2RS232 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)

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Connections to the Sample Gas Exhaust

2 Installation and Patient Safety

3Equipotential Grounding Terminal; this is used to connect the AGM to the hospital’s grounding system.

4Line protection fuses, T1 A H 250V.

5Anesthetic gas exhaust. If N2O and/or other inhalation anesthetics are used during anesthesia, 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.

6Zero Gas Exhaust

7Fan Filter

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	Tubing includes two parts:
		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)

1Fit the male luer lock connection (2) of the shorter tube, to the female side of the M1656A Gas Exhaust Return Filter.

2Fit the female luer lock connection (3) of the longer tube, to the male side of the M1656A Gas Exhaust Return Filter.

3Fit the open end (7) of the longer tube to the AGM’s Anesthetic Gas Exhaust.

4Fit the open end (5) of the shorter tube to the ventilation circuit.

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2 Installation and Patient Safety

Setup and Configuration Procedures

Figure 6 Setting Up the M1655A Gas Exhaust Return Line

1M1656A Gas Exhaust Return Filter

2Female luer lock

3Male luer lock

4Dampener

5Shorter tube

6Connecting tube

7Longer 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:

1A ventilator reservoir where the suction pressure does not exceed 0.3-0.4 mmHg or

2A 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.

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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.

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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 3- wire 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.

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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