Module Frames and Modules Technical Manual Oct 2016

Master table of contents Module Frames and Modules Technical Manual Order code #2062978-001 DVD #2062978-002 DVD 510(k) #2062973-004 paper

Description

Tab

About this manual

1

PRESTN Modules, E-PRESTN, E-RESTN, E-PRETN Patient Side Modules, E-PSM, E-PSMP Rev.01

2

PiCCO Module, E-PiCCO

3

Cardiac Output Modules E-COP and E-COPSv Rev. 01

4

Pressure Module, E-P, Pressure Temp Module, E-PT, Dual Pressure Module, E-PP

5

Masimo Module, E-MASIMO

6

Nellcor Compatible Saturation Module, E-NSATX

7

Respiratory Modules, E-sCAiOVX, E-sCAiOV, E-sCAiO, E-sCOVX, E-sCOV, E-sCO

8

Compact Airway Modules, E-CAiOVX, E-CAiOV, E-CAiO, E-COVX, E-COV and E-CO

9

Single-width Airway Module, E-miniC

10

Entropy Module, E-ENTROPY Rev. 01

11

EEG Module, E-EEG and EEG Headbox, N-EEG

12

BIS Module, E-BIS Rev. 01

13

NeuroMuscular Transmission Module, E-NMT Rev. 01

14

Module Frames F5, F7

15

PDM Module v2

16

2062973-004

Module Frames and Modules

For your notes:

2062973-004

Table of contents

Table of contents 1

About this manual 1.1 1.2 1.3 1.4 1.5

1-1

Intended use of the manual... 1-1 Intended audience of the manual... 1-1 Third party trademarks... 1-1 ESD awareness... 1-1 Service requirements... 1-1 1.5.1 Equipment identification... 1-2 1.5.2 Serial number label... 1-2 1.5.3 Device plate location... 1-3 1.5.4 Access to Webmin... 1-3

1-i 2062973-004

Module Frames and Modules

1 - ii 2062973-004

About this manual

1

About this manual

1.1 Intended use of the manual This Module Frames and Modules Technical Manual must be used in conjunction with the CARESCAPE modular monitor’s technical manual for important safety information. This manual contains instructions necessary to perform planned and corrective maintenance to the parameter modules and module frames. Use it as a guide for maintenance and repairs considered field repairable. Where necessary the manual identifies additional sources of relevant information and technical assistance. See the patient monitor’s technical manual for an overview of the patient monitoring system, information needed for system installation and for planned and corrective maintenance. See the supplemental information manual for the technical specifications, default settings and compatibility information, including electromagnetic compatibility. See the patient monitor’s user's manual for the instructions necessary to operate the device safely in accordance with its function and intended use.

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

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

1.4 ESD awareness The system complies with IEC 60601-1-2:2001 + A:2004. In accordance with IEC 60601-1-2, modules marked with the ESD warning symbol (IEC 60417-5134) require user training in ESD awareness and prevention as follows:

•

The contents of the training are specified in the local ESD Control Program Plan, issued in accordance with IEC 61340-5-1. The training should at least include an introduction to ESD and its impacts on electrical devices and how to prevent it by using appropriate personal protection equipment, proper work practices and tools.

1.5 Service requirements General service requirements and qualification requirements for the service personnel. Follow the service requirements listed below. −

Refer equipment servicing to GE authorized service personnel only.

−

Any unauthorized attempt to repair equipment under warranty voids that warranty.

−

It is the user’s responsibility to report the need for service to GE or to one of their authorized agents.

−

Failure on the part of the responsible individual, hospital, or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.

1-1 2062973-004

Module Frames and Modules

−

Regular maintenance, irrespective of usage, is essential to ensure that the equipment will always be functional when required.

1.5.1 Equipment identification Every GE device has a unique serial number for identification. A sample of the information found on a serial number label is shown below.

Description A

product code

B

year manufactured

C

fiscal week manufactured

D

production sequence number

E

manufacturing site

F

miscellaneous characteristic

1.5.2 Serial number label An example of a serial number label of an E-module is shown below.

Description TYPE Device type e.g. E-NMT SN

1-2 2062973-004

Serial number

About this manual

1.5.3 Device plate location The device plate is located between the docking rails of the PDM module and on the inside of the module frames F5 and F7.

Figure 1

Device plate location, Patient Data Module and module frames

The device plate is located beside the docking rails of the E-PSM and E-PSMP modules and on the left side of the plug-in E-modules.

Figure 2

Device plate location, E-PSM and E-modules

1.5.4 Access to Webmin Webmin can be accessed locally through the CARESCAPE monitor or remotely from a configured service laptop connected to the CARESCAPE monitor. For information about Webmin, see the CARESCAPE monitor’s technical manual.

1-3 2062973-004

Module Frames and Modules

For your notes:

1-4 2062973-004

Hemodynamic Modules E-PRESTN, E-RESTN, E-PRETN (Rev. 00) E-PSMP, E-PSM (Rev. 01) Technical Manual

2

Table of contents

Table of contents 1

Product overview 1.1 1.2

1.3

2

3

3.2 3.3 3.4

4.2 4.3

2-22

Replacement of planned maintenance parts... 2-22 3.1.1 Required parts... 2-22 3.1.2 Replacement procedures... 2-22 Visual inspections... 2-22 Electrical safety tests... 2-23 Functional check... 2-23 3.4.1 Setup... 2-23 3.4.2 ECG tests... 2-27 3.4.3 Impedance respiration tests... 2-27 3.4.4 Invasive pressure tests... 2-28 3.4.5 Temperature tests... 2-28 3.4.6 SpO2 tests... 2-28 3.4.7 NIBP tests... 2-29 3.4.8 Test completion... 2-30

Calibration and adjustments 4.1

2-20

STP/TP /ST-Settings... 2-20 2.1.1 Configuration... 2-20

Maintenance and checkout 3.1

4

Introduction... 2-1 Measurement principle... 2-2 1.2.1 ECG... 2-2 1.2.2 Respiration... 2-2 1.2.3 Invasive blood pressure... 2-2 1.2.4 Temperature... 2-2 1.2.5 Pulse oximetry... 2-3 1.2.6 NIBP... 2-5 Main components... 2-6 1.3.1 Controls and connectors... 2-6 1.3.2 E-PSM(P) and E-(P)RE(S)TN modules... 2-8 1.3.3 ECG board... 2-9 1.3.4 STP board... 2-11 1.3.5 NIBP board... 2-16

Configuration 2.1

2-1

2-31

Invasive pressure calibration... 2-31 4.1.1 Setup... 2-31 4.1.2 Procedure... 2-32 Temperature calibration... 2-33 4.2.1 Setup... 2-33 4.2.2 Procedure... 2-33 NIBP calibration... 2-34

2-i 2062973-004

Module Frames and Modules

4.3.1 Setup... 2-35 4.3.2 Procedure... 2-35

5

Troubleshooting 5.1 5.2 5.3

5.4

5.5

6

6.2 6.3

7

7.3 7.4

2-50

Disassembly guidelines... 2-50 6.1.1 ESD precautions... 2-50 6.1.2 Before disassembly... 2-50 6.1.3 Required tools... 2-51 Disassembling and reassembling procedure, E-PRESTN, E-PRETN, E-RESTN... 2-51 6.2.1 Removing the pump unit... 2-57 6.2.2 Replacing the NIBP air filter... 2-58 Disassembling and reassembling procedure, E-PSMP and E-PSM... 2-58 6.3.1 Removing the pump unit... 2-62 6.3.2 Removing the manifold unit... 2-63 6.3.3 Removing the module bus connector... 2-64 6.3.4 Replacing the NIBP air filter... 2-65

Service parts 7.1 7.2

8

Visual inspection... 2-38 Troubleshooting checklist... 2-38 Service Interface... 2-39 5.3.1 Configuration Information... 2-39 5.3.2 Device Information... 2-39 5.3.3 Log files... 2-39 Messages... 2-40 5.4.1 ECG... 2-40 5.4.2 Impedance respiration... 2-42 5.4.3 Invasive Pressure... 2-42 5.4.4 Temperature... 2-44 5.4.5 SpO2... 2-44 5.4.6 NIBP... 2-45 Troubleshooting chart... 2-49 5.5.1 Invasive Pressure... 2-49 5.5.2 Temperature... 2-49

Disassembly and reassembly 6.1

2-38

2-66

Ordering parts... 2-66 E-PRESTN, E-PRETN, E-RESTN... 2-67 7.2.1 Front cover for E-PRESTN, E-PRETN, E-RESTN... 2-70 Patient Side Modules, E-PSM, E-PSMP (Rev. 01)... 2-72 Patient Side Modules, E-PSM, E-PSMP (Rev. 00)... 2-74 7.4.1 Front panel labeling, E-PSM(P) (Rev. 00 and 01)... 2-75 7.4.2 Spare parts for PSM mounts... 2-76

Earlier revisions

2-77

Maintenance check form

2-79

2 - ii 2062973-004

Hemodynamic Modules E-PRESTN, E-RESTN, E-PRETN, E-PSMP, E-PSM

1

Product overview

1.1 Introduction This document provides information for the maintenance and service of the Patient Side Modules E-PSMP and E-PSM, and the double-width plug-in hemodynamic modules, E-PRETN, E-PRESTN and E-RESTN. These modules provide general hemodynamic parameters.

Figure 1

Patient Side Module, E-PSMP, and Hemodynamic Module, E-PRESTN.

Parameter

E-PSMP

E-PSM

E-PRESTN

E-RESTN

E-PRETN

ECG

X

X

X

X

X

Impedance respiration

X

X

X

X

X

Two invasive blood pressures

X

Two temperatures

X

X

X

X

Pulse oximetry

X

X

X

X

NIBP

X

X

X

X

X

X X

X

Equipment safety symbols Safety symbol for the E-PSMP and E-PSM modules: This symbol on the module refers to defibrillator precautions. To ensure protection against the effects of cardiac defibrillator discharge, always use the recommended cables and leadwires only (see the supplemental information manual). Using other cables or leadwires may result in damage to the equipment and compromise patient and/or user safety.

2-1 2062973-004

Module Frames and Modules

Safety symbol for the E-PRESTN, E-RESTN, and E-PRETN modules: When displayed on the module, indicates that protection against cardiac defibrillator discharge is due in part to the accessories for pulse oximetry (SpO2), temperature (T) and invasive pressure (P) measurement.

1.2 Measurement principle 1.2.1 ECG Electrocardiography analyzes the electrical activity of the heart by measuring the electrical potential produced with electrodes placed on the surface of the body. ECG reflects:

• • • •

electrical activity of the heart normal/abnormal function of the heart effects of anesthesia on heart function effects of surgery on heart function

See the patient monitor’s user’s manual for electrodes’ positions and other information.

1.2.2 Respiration Impedance respiration is measured across the thorax between ECG electrodes. The respiration signal is made by supplying current between the electrodes and by measuring the differential current from the electrodes. The signal measured is the impedance change caused by breathing. The respiration rate is calculated from these impedance changes, and the respiration waveform is displayed on the screen.

1.2.3 Invasive blood pressure To measure invasive blood pressure, a catheter is inserted into an artery or vein. The invasive pressure setup, consisting of a connecting tubing, a pressure transducer, an intravenous bag of normal saline, all connected together by stopcocks, is attached to the catheter. The transducer is placed at the same level with the heart, and is electrically zeroed. The transducer is a piezo-resistive device that converts the pressure signal to a voltage. The monitor interprets the voltage signal so that pressure data and pressure waveforms can be displayed.

1.2.4 Temperature The temperature is measured by a probe whose resistance varies when the temperature changes, called NTC (Negative Temperature Coefficient) resistor. The resistance can be measured by two complementary methods:

2-2 2062973-004

•

Applying a constant voltage across the resistor and measuring the current that flows through it.

•

Applying a constant current through the resistor and measuring the voltage that is generated across it.

Hemodynamic Modules E-PRESTN, E-RESTN, E-PRETN, E-PSMP, E-PSM

These modules use the constant current method. The NTC-resistor is connected in series with a normal resistor and a constant voltage is applied across them. The temperature dependent voltage can be detected at the junction of the resistors, thus producing the temperature signal from the patient. The signal is amplified by analog amplifiers and further processed by digital electronics.

1.2.5 Pulse oximetry A pulse oximeter measures the light absorption of blood at two wavelengths, one in the near infrared (about 940 nm) and the other in the red region (about 660 nm) of the light spectrum. These wavelengths are emitted by LEDs in the SpO2 probe, the light is transmitted through peripheral tissue and is finally detected by a PIN-diode opposite the LEDs in the probe. The pulse oximeter derives the oxygen saturation (SpO2) using an empirically determined relationship between the relative absorption at the two wavelengths and the arterial oxygen saturation SaO2. In order to measure the arterial saturation accurately, pulse oximeters use the component of light absorption giving variations synchronous with heart beat as primary information on the arterial saturation. A general limitation of pulse oximetry is that due to the use of only two wavelengths, only two hemoglobin species can be discriminated by the measurement. The modern pulse oximeters are empirically calibrated either against fractional saturation SaO2frac;

HbO 2 SaO 2 frac = ---------------------------------------------------------------------------HbO 2 + Hb + Dyshemoglobin

Formula 1

or against functional saturation SaO2func;

HbO 2 SaO 2 func = ---------------------------HbO 2 + Hb

Formula 2

Functional saturation is more insensitive to changes of carboxyhemoglobin and methemoglobin concentrations in blood. The oxygen saturation percentage SpO2 measured by the module is calibrated against functional saturation SaO2func. The advantage of this method is that the accuracy of SpO2 measurement relative to SaO2func can be maintained even at rather high concentrations of carboxyhemoglobin in blood. Independent of the calibration method, pulse oximeters are not able to correctly measure oxygen content of the arterial blood at elevated carboxyhemoglobin or methemoglobin levels.

Plethysmographic pulse wave The plethysmographic waveform is derived from the IR signal and reflects the blood pulsation at the measuring site. Thus the amplitude of the waveform represents the perfusion.

2-3 2062973-004

Module Frames and Modules

Pulse rate The pulse rate calculation is done by peak detection of the plethysmographic pulse wave. The signals are filtered to reduce noise and checked to separate artifacts.

Figure 2

Absorption of infrared light in the finger

SpO 2 sensor connector

RED

Detector

Figure 3

2-4 2062973-004

Pulse oximetry probe parts layout and schematic diagram

PSM_absorption_of_infrared.vsd

IRED

Em itter

Hemodynamic Modules E-PRESTN, E-RESTN, E-PRETN, E-PSMP, E-PSM

The standard probe is a finger clamp probe which contains the light source LEDs in one half and the photodiode detector in the other half. Different kinds of probes are available from GE Healthcare.

1.2.6 NIBP NIBP (Non-Invasive Blood Pressure) is an indirect method for measuring blood pressure. The NIBP measurement is performed according to the oscillometric measuring principle. The cuff is inflated with a pressure slightly higher than the presumed systolic pressure, and deflated at a speed based on the patient’s pulse, collecting data from the oscillations caused by the pulsating artery. Based on these oscillations, values for systolic, mean, and diastolic pressures are calculated. The following parts are necessary for the NIBP measurement:

• • •

a parameter module twin hose (adult or infant model) blood pressure cuffs (various sizes)

2-5 2062973-004

Module Frames and Modules

1.3 Main components 1.3.1 Controls and connectors

Figure 4

Front and back panel connectors of E-PRESTN module

Module keys

Module

Description

Auto On/Off

E-PRESTN, E-PRETN, E-RESTN

Starts and stops autocycling NIBP measurements Starts a single NIBP measurement, and cancels any measurement.

Start Cancel Zero P1

E-PRESTN, E-PRETN

Zero P2

2-6 2062973-004

Zeroes P1 Zeroes P2

Connector

Module

Description

NIBP

E-PRESTN, E-PRETN, E-RESTN

NIBP connector (black)

P1-P2

E-PRESTN, E-PRETN

InvBP connector (red)

T1-T2

E-PRESTN, E-PRETN, E-RESTN

Temperature connector (brown)

SpO2

E-PRESTN, E-RESTN

SpO2 connector (blue)

ECG

E-PRESTN, E-PRETN, E-RESTN

ECG and impedance respiration connector (green)

D25 connector

E-PRESTN, E-PRETN, E-RESTN

Module bus connector

Hemodynamic Modules E-PRESTN, E-RESTN, E-PRETN, E-PSMP, E-PSM

 
 



 



Figure 5

 
  



Front panel and connectors of E-PSMP module and the back of the module

Module keys

Module

Description

Auto On/Off

E-PSM, E-PSMP

Starts and stops autocycling NIBP measurements Starts a single NIBP measurement, and cancels any measurement.

Start Cancel Zero P1

E-PSMP

Zero P2

Zeroes P1 Zeroes P2

Connector

Module

Description

NIBP

E-PSM, E-PSMP

NIBP connector (black)

P1-P2

E-PSMP

InvBP connector (red)

T1-T2

E-PSM, E-PSMP

Temperature connector (brown)

SpO2

E-PSM, E-PSMP

SpO2 connector (blue)

ECG

E-PSM, E-PSMP

ECG and impedance respiration connector (green)

Tab for removing the module

E-PSM, E-PSMP

Detachment tab (gray)

5 pin connector

E-PSM, E-PSMP

Module bus connector

2-7 2062973-004

Module Frames and Modules

1.3.2 E-PSM(P) and E-(P)RE(S)TN modules The modules contain three main PC boards, the STP board, the ECG board, and the NIBP board. Each of these boards contain a processor and software in the processor flash memory. The boards produce their own supply voltages from the Vmod 13.8-16 V line that is available via the module bus connector. In addition to this, the NIBP board provides +5V for the ECG and STP board non-isolated side components. The NIBP board provides also the synchronization signal for the ECG and STP board power supplies. There are two input boards; the STP input board and the ECG input board attached to the front panel of the module. The front panel has five connectors and four keys. There is one connector for two temperature measurements, one for two invasive blood pressure measurements, one for ECG, one for NIBP, and one for SpO2 measurement. The NIBP connector includes two plungers for NIBP hose identification. The keys are for NIBP Auto On/Off, NIBP Start/Cancel, P1 zero, and P2 zero. NOTE: The connectors and keys depend on the module variant, and some variants may not have all the mentioned connectors and keys.

2-8 2062973-004