E-miniC Service Manual 3rd edition Aug 2020

Due to continuing product innovation, specifications in this manual are subject to change without notice. For technical documentation purposes, the abbreviation GE is used for the legal entity names, GE Medical Systems Information Technologies, Inc. and GE Healthcare Finland Oy.

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Contents 1

About this manual ... 7 Intended use of this manual... 7 Intended audience of this manual ... 7 Manual conventions ... 7 Illustrations and names ... 8 Related documents... 8 Product availability ... 8 Trademarks ... 8 Third party trademarks ... 8 Manufacturer responsibility ... 8

2

Module introduction ... 9 E-miniC module introduction ... 9 Module compatibility ... 9 Airway gases equipment to patient connections with E-miniC, critical care setup... 9 Controls and connectors ... 9 Measurement principle... 10 CO2 measurement... 10 Main components ... 11 Gas sampling system... 11 MiniC sensor ... 14 CPU board... 14

3

Planned and corrective maintenance ...15 About the maintenance check procedures ... 15 Planned maintenance... 15 Replacement of planned maintenance parts*... 16 Required parts ... 16 Replacing planned maintenance parts*... 16 Corrective maintenance ... 17 Performing visual inspection... 18 Performing functional check ... 18

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Required tools... 18 Making connections for the functional check ... 18 Configuring monitor for CO2 functional check ... 18 Testing E-miniC module features ... 19 Completing the functional check ... 21 4

Configuration and calibration...23 Configuration ... 23 Calibration and adjustments... 23 Sample flow rate adjustment ... 23 Gas calibration ... 25

5

Troubleshooting...29 Troubleshooting guidelines ... 29 Performing visual inspection... 29 Troubleshooting checklist... 30 Gas sampling system troubleshooting ... 30 MiniC sensor troubleshooting... 31 Viewing device information... 31 Service log files... 31 Viewing log files... 31 Downloading log files... 31 Messages related to CO2 ... 32 Troubleshooting CO2 measurement ... 34

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Disassembly and reassembly...37 Disassembly guidelines ... 37 Serviceable parts... 37 Service limitations ... 37 ESD precautions ... 38 Protection from dust ... 38 Before disassembly ... 38 Required tools... 39 Disassembly procedures ... 39 Detaching the module casing ... 39 Detaching the pump unit... 39 Detaching the MiniC assembly... 40

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Reassembling the module ... 40 7

Service parts...41 Ordering parts ... 41 Exploded view of Single-width Airway Module, E-miniC... 42 Gas exhaust connectors ... 43 List of FRUs for E-miniC... 44

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About this manual

1

Intended use of this manual This manual contains instructions for the planned and corrective maintenance of the acquisition module. This manual must be used together with the monitor’s service manual for important safety and installation information. Use the manual as a guide for maintenance procedures and repairs considered field repairable. Where necessary the manual identifies additional sources of relevant information and technical assistance. See the monitor’s service manual for an overview of the patient monitoring system, information needed for system installation and for planned and corrective maintenance of the monitor. See the monitor’s supplemental information manual for the technical specifications, default settings and compatibility information, including electromagnetic compatibility. See the monitor’s user manual for the instructions necessary to operate the device safely in accordance with its function and intended use.

Intended audience of this manual This manual is intended for service representatives and technical personnel who maintain, troubleshoot, or repair this device.

Manual conventions This manual uses the following styles to emphasize text or indicate an action. Also note the terminology conventions.

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Item

Description

bold

Indicates hardware keys and connectors.

bold italic

Indicates menu options, software keys and messages.

italic

Indicates terms for emphasis.

>

Indicates menu options to select consecutively.

select

The word select means choosing and confirming.

supplemental information

In this manual, the phrase supplemental information refers to information that appears in the Supplemental Information Manual or supplements provided.

NOTE

Note statements provide application tips or other useful information.

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About this manual

Illustrations and names This manual uses illustrations as examples only. Illustrations in this manual may not necessarily reflect all system settings, features, configurations, or displayed data. Names of persons, institutions, and places and related information are fictitious; any similarity to actual persons, entities, or places is purely coincidental.

Related documents ●

CARESCAPE monitor’s service manual

●

CARESCAPE monitor’s user manual

●

CARESCAPE monitor’s supplemental information manual

●

Cleaning and Disinfecting Supplement

●

Supplies and Accessories Supplement

Product availability NOTE

Due to continual product innovation, design and specifications for these products are subject to change without notice.

Some of the products mentioned in this manual may not be available in all countries. Please consult your local representative for the availability.

Trademarks GE, GE Monogram, and CARESCAPE are trademarks of General Electric Company.

Third party trademarks All third party product and company names are the property of their respective owners.

Manufacturer responsibility GE is responsible for the effects on safety, reliability, and performance of the equipment only if: ●

Assembly operations, extensions, readjustments, modifications, servicing, or repairs are carried out by authorized service personnel.

●

The electrical installation of the relevant room complies with the requirements of the appropriate regulations.

●

The equipment is used in accordance with the instructions for use.

●

The equipment is installed, maintained and serviced in accordance with the instructions provided in the related service manuals.

WARNING

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SAFETY HAZARD. To avoid risks to personnel and patient, or damage to the equipment, only perform maintenance procedures described in this manual. Unauthorized modifications can lead to safety hazards.

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Module introduction

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E-miniC module introduction This document provides information for the maintenance and service of the Single-width Airway Module, E-miniC. The Single-width Airway Module provides airway and respiratory measurements. Letter C in the module name stands for CO2.

Module compatibility For detailed information regarding module, monitor, and accessory compatibility, see the supplemental information provided.

Airway gases equipment to patient connections with E-miniC, critical care setup

1.

E-miniC module

2.

Sampling line connector on the water trap

3.

Gas sampling line

4.

Adapter with sampling line connector

5.

Heat and moisture exchanger with filter (HMEF)

Controls and connectors Front panel of the E-miniC module and the back of the module:

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Module introduction

1.

Water trap latch

2.

Sampling line connector

3.

Mini D-fend water trap

4.

Sample gas outlet There are two types of connectors as indicated in the following figure:

a. Module with Luer exhaust connector: use Luer gas exhaust lines. b. Module with GE custom exhaust connector: use GE gas exhaust lines. Connector

Module

Description

D25 connector

E-miniC

Module bus connector

Measurement principle CO2 measurement E-miniC is a side stream gas analyzer, measuring real time concentrations of CO2. It is a non-dispersive infrared analyzer that measures absorption of the gas sample by using an optical narrow band filter. The infrared radiation detector is a thermopile. Concentration of CO2 is calculated from absorption measured at 4.2 to 4.3 μm. The following illustrates the absorbance of CO2:

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Module introduction

Main components Gas sampling system The sampling system draws a gas sample to the analyzer at a fixed rate. The gas sampling system samples the measured air to the module and removes water and impurities from it. A sampling line is connected to the water trap. The pump draws gas through the sampling line to the miniC sensor. After the measurement, the gas is exhausted from the sample gas out connector. The sample flow is nominally 150 ml/min. The following illustrates the MiniC block diagram:

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Module introduction

Mini D-fend The sample is drawn through the sampling line. The gas then enters the module through the water trap where it is divided into two flows, a main flow and a side flow. The main flow goes into the analyzer. This flow is separated from the patient side by a hydrophobic filter. The side flow creates a slight subatmospheric pressure within the Mini D-fend water trap which causes fluid removed by the hydrophobic filter to collect in the bottle.

Zero valve The main flow passes through a magnetic valve before proceeding to the analyzer. This valve is activated to establish the zero point for the MiniC sensor. When the valve is activated, room air is drawn through a filter into the internal system and the gas sensor.

Dehumidification tube A dehumidification tube is used between the water trap and the zero valve to balance the sample gas humidity with that of ambient air. The tube will prevent errors caused by the effect of water vapor on gas partial pressure, when humid gases are measured after calibration with dry gases.

Gas analyzers After the zero valve and dehumidification tube, the gas passes through the miniC sensor.

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Module introduction

Sample flow differential pressure transducer The sample flow differential pressure transducer measures pressure drop across a restrictor and calculates the sample flow from the pressure difference.

Working pressure transducer The working pressure transducer measures differential pressure between the tubing and ambient air near the miniC sensor. The following messages are based on the obtained pressure values: Sample line blocked, Check Water Trap, Replace Water Trap, and Check sample gas out.

Absolute pressure transducer The absolute pressure transducer measures real-time ambient pressure.

Sampling pump The gas sampling pump is a membrane pump run by a DC motor. Sample flow is measured with a differential pressure transducer across a known restriction. The motor is automatically controlled to maintain a constant flow even when the Mini D-fend water trap ages and starts to get occluded. It also enables the use of sample tubes with varying lengths and diameters. NOTE

In no occasion is the flow reversed towards the patient.

The following illustrates the gas tubing layout:

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Module introduction

MiniC sensor The miniC sensor is a non-dispersive infrared analyzer measuring absorption of the gas sample at 4.2 to 4.3 μm infrared wavelength, which is selected using an optical narrow band filter. The IR lamp is a filament surrounded by thermal isolation. There is a hole in the isolation, passing radiation to a conical measuring chamber with 3 mm length. From the sample chamber, the radiation goes into a thermopile detector with an optical filter in front of it. The temperature sensor measures the temperature of the miniC sensor and it is used for temperature compensation. The miniC sensor is connected to the CPU board and they cannot be replaced separately.

CPU board The CPU board contains a processor, memories and all the analog signal processing needed. A miniC sensor is attached to the board with a flexible PCB. Also supply voltage and an RS485 serial channel are connected to the CPU board using another flex cable. Analog signals (CO2, temperature, absolute and differential pressures, and lamp current signals) are fed to a 16-bit A/D converter. The processor controls the A/D converter and calculates the CO2 percentage and respiration rate from this data. The processor controls sample flow by adjusting the pump voltage based on the differential pressure signal. The processor also controls the current of the IR source and keeps it constant. Calibration data is stored on the EEPROM.

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Planned and corrective maintenance About the maintenance check procedures

This chapter describes the planned and corrective maintenance check procedures for the product. To help ensure the equipment remains in proper operational and functional order and maintains its essential performance and basic safety, follow the corrective and planned maintenance instructions. The tests and the replacement of planned maintenance parts that are related to the essential performance and basic safety are marked with the *. The cleaning precautions, cleaning requirements, cleaning procedures, and recommended cleaning solutions are described in the monitor’s user manual or supplemental information provided. For details about cleaning, disinfecting and sterilizing the accessories, see the instructions for use in the accessory package. Record the results of the planned and the corrective maintenance check procedures to the eCheckforms delivered in the electronic manual media. WARNING

SAFETY HAZARD. To avoid risks to personnel and patient, or damage to the equipment, only perform maintenance procedures described in this manual. Unauthorized modifications can lead to safety hazards.

CAUTION

EQUIPMENT DAMAGE. Do not apply pressurized air or gas to any outlet or tubing connected to the monitor. Pressure may destroy sensitive elements.

Planned maintenance WARNING

PATIENT SAFETY. Planned maintenance must be carried out at the specified interval. Failure to implement the maintenance schedule may cause equipment failure and possible health hazards.

Perform the planned maintenance procedure completely every 12 months after installation. Perform the procedure in the following order:

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1.

Replacement of planned maintenance parts *

2.

Visual inspections

3.

Functional check

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Planned and corrective maintenance

Replacement of planned maintenance parts* Required parts Replace the following parts that wear in use at the following interval. Description

Pieces

Replacement interval

Dehumidification tube

1

Once a year

Mini D-fendTM O-ring

2

Once a year

Zero valve air filter

1

Once every 3 years

GE recommends that you replace the Mini D-fend water trap and the gas sampling line as part of the planned maintenance procedure. NOTE: See the supplemental information provided for compatible accessories.

Replacing planned maintenance parts* Replace the specified planned maintenance parts according to the following procedure. For more information, see chapter Disassembly and reassembly and chapter Service parts. 1.

Replace the zero valve air filter once every 3 years. a. Use a small flat blade screwdriver to pull the old zero line air filter. b. Attach a new zero line air filter into place.

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2.

Replace the dehumidification tube and check the condition of the internal tubing. a. Replace the 300 mm dehumidification tube in the sample gas line between the Mini D-fend water trap and the zero valve unit. b. Check that the tubing inside the module is not contaminated. Any contamination inside the tubing may indicate that the valve or sensor is contaminated, too. This can increase a risk of faulty operation in valve or sensor. You cannot clean the gas sensor in the field. Therefore, replace the whole E-MiniC assembly with a new one. NOTE: The dehumidification tubes do not include the silicon fittings they connect to. Use the original silicon fittings unless they are damaged or leaking.

3.

Replace the Mini D-fend O-rings. a. Detach the Mini D-fend. b. Detach the old rubber O-rings that are around the metal Mini D-fend connectors e.g. using a small flat blade screwdriver. Pay special attention not to scratch the metal Mini D-fend connectors and thus causing leaking. c. Set the new rubber O-rings into place and attach a new Mini D-fend.

Corrective maintenance Perform the following check procedure after any corrective maintenance, before taking the product back into clinical use:

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Planned and corrective maintenance

Required checkout procedure Performed service activity

Visual inspection

Functional check

Front cover replacement

All steps

Not applicable.

Mini D-fend O-rings

All steps

Perform the following tests: ● Check the gas sampling system for

possible leakages. * ● Check sample flow rate. *

Module case opened either for troubleshooting purpose or for replacing any of the internal parts.

All steps

All steps

Performing visual inspection 1.

Detach the module from the module slot and check that: a. The front cover is intact. b. All connectors and intact, clean and attached properly. c. The module casing and the latch are clean and intact. d. The metal D-fend connectors and the D-fend O-rings are clean and intact. e. The module and gas sampling tubes are clean and intact.

Performing functional check Required tools ●

A barometer.

●

A mass flowmeter for measuring air flow, minimum measurement range 100-300 ml/min, accuracy 5% or better in the 100-300 ml/min range.

●

P/N: 755534-HEL Calibration Gas Regulator.

●

P/N: M1006864 Calibration Gas Regulator (US only).

●

P/N: 755580 Calibration gas 5% CO2 and air, package of 4 cans.

●

3 m / 10 ft gas sampling line.

●

A pressure manometer with either an integrated or separate pressure pump.

NOTE: See the supplemental information provided for compatible accessories.

Making connections for the functional check Disconnect the module from the monitor, if connected.

Configuring monitor for CO2 functional check 1.

Configure the CO2 waveform field to the monitor screen with adequate priority.

2.

Select Gases > CO2 > Setup and configure: FiO2 level: 21-40%

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Planned and corrective maintenance

Testing E-miniC module features 1.

Check the gas sampling system for possible leakages. * a. Disconnect the module from the monitor. b. Connect a new Mini D-fend water trap to the module. c. Connect a new gas sampling line to the sampling line connector in the water trap. d. Connect the other end of the gas sampling line to a pressure manometer and a pressure pump. e. Block the "Sample Gas Out" connector. f.

Pump 100 mmHg ± 20 mmHg pressure to the gas sampling system. Let the pressure stabilize for approximately 10 seconds.

g. Check that the pressure reading does not drop more than 6 mmHg during 1 minute. 2.

Check the sample flow rate. * NOTE: Gas measurement is not available during the first 1 minute after the module is connected due to warm-up. Message Calibrating Gas Sensor is shown in the waveform field. Wait until warm-up is completed before proceeding with the next steps. NOTE: The ambient temperature and air pressure influence the flow rate measured by the flow meter. A flow meter, which has been calibrated at 21.1°C (70°F) and 760 mmHg (1013 mbar), measures the flow rate correctly under the same conditions, i.e. in room temperature at sea level. A flow rate correction as instructed by the manufacturer of the flow meter needs to be performed when measuring flow rate under other conditions, for example in high altitude. a. Connect the module with the gas sampling line to the monitor. b. Connect the gas sampling line to the sampling line connector in the water trap. c. Connect the other end of the gas sampling line to a flowmeter. d. Check the sample flow rate reading from the flowmeter. The flow rate should be within the specification limit 150 ± 25 ml/min. NOTE: You need to readjust if the measured value is not within the specification limits. Adjust the sample gas flow rate according to the instructions in section Sample flow rate adjustment. NOTE: If the sampling pump is noisy, it indicates possible problems with the motor bearing. In this case GE Healthcare recommends that you replace the noisy sampling pump with a new one.

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Planned and corrective maintenance

3.

Test the zero valve functionality. * a. Connect the gas regulator to the calibration gas container. b. Connect the end of the gas sampling line to the regulator on the gas container. Leave the regulator overflow port open to room air. c. Select Monitor Setup > Main Setup > Parameter Setup > Gases. d. Select CO2 > Setup and check that Gas Module (Mod) has been selected as Measurement Source. e. Select Monitor Setup > Defaults & Service > Service Calibrations. f.

Enter the Username and the Password and press Enter to access the Service / Calibrations menu.

g. Select Gases. h. Start feeding calibration gas. Wait until the CO2 value in the calibration menu rises to approximately 5%. i.

Open the zero air valve to room air by selecting Zero valve : Off button (zero position).

j.

Check that the CO2 value in the calibration menu drops back near to 0%.

k. Stop feeding the calibration gas. l.

Turn the zero valve back to the normal measurement position by selecting Zero valve : On button.

4.

Perform the gas calibration according to the instructions in section Gas calibration. *

5.

Use a barometer to check the operation of the absolute pressure sensor. * a. Check that the ambient pressure value shown in the Main menu for calibrations does not differ more than ± 10 mmHg from the value shown by the barometer.

6.

Check the occlusion detection. * a. Block the tip of the sampling line with your finger. b. Check that the message Sample line blocked appears to the parameter window within 30 seconds.

7.

Check the air leak detection. * a. Detach the Mini D-fend water trap. b. Check that the message Check Water Trap appears to the parameter window within 30 seconds.

8.

Gas exhaust blockage * a. Block the gas exhaust connector with your finger. b. Check that the Sample gas out message appears in the parameter window within 30 seconds.

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9.

Check the airway gases. * a. Breathe a minimum of 5 times to the tip of the sampling line. b. Check that a normal CO2 waveform appears to the waveform field and the EtCO2 and FiCO2 values are updated to the parameter window.

10. Check the apnea detection. a. Stop breathing to the gas sampling line. b. Check that an Apnea alarm appears to the message field within 30 seconds.

Completing the functional check

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1.

Select Discharge Patient or Reset Case to discard any changes made to the monitor configuration during the functional check.

2.

Disconnect the test setup.

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