Sentec SDM Manuale utente

For the SenTec Digital Monitoring System

(Software Version SMB V08.02; MPB V06.02)

HB-005615-j Service Manual

Warranty

The manufacturer warrants to the initial purchaser that each new SenTec Digital

Monitor will be free from defects in workmanship and materials. The manufacturer’s

sole obligation under this warranty is to at its own choice repair or replace any monitor

–for which the manufacturer acknowledges the warranty cover –with a replacement

monitor.

Warranty Exclusions and System Performance

SenTec AG can neither guarantee or verify instrument performance characteristics nor

accept warranty claims or product liability claims if the recommended procedures are

not carried out, if the product has been subject to misuse, neglect or accident, if the

product has been damaged by extraneous causes, if accessories other than those

recommended by SenTec AG are used, if the warranty seal on the lower side of the

monitor is broken, or if instrument repairs are not carried out by SenTec authorized

service personnel.

CAUTION: Federal law (U.S.) restricts this device to sale by or on the order of a physician.

Patents/Trademarks/Copyright

International Industrial Design No. DM/054179, Japanese Design No. 1137696, U.S.

Design Patent No. D483488.

Canadian Patent No. 2466105, European Patent No. 1335666, German Patent No.

50111822.5-08, Spanish Patent No. 2278818, Hongkong Patent No. HK1059553, U.S.

Patent No. 6760610.

Chinese Patent No. ZL02829715.6, European Patent No. 1535055, German Patent No.

50213115.2, Spanish Patent No. 2316584, Indian Patent No. 201300, Japanese Patent

No. 4344691, U.S. Patent No. 7862698.

SenTec™, V-Sign™, V-STATS™, V-CareNeT™, V-Check™, Staysite™, OxiVenT™,

Advancing Noninvasive Patient Monitoring™, and Illuminate Ventilation™ are

this document may not be reproduced in any form or communicated to any third party

without the prior written consent of SenTec AG. While every effort is made to ensure

the correctness of the information provided in this document, SenTec AG assumes no

responsibility for errors or omissions. This document is subject to change without

notice.

SenTec AG, Ringstrasse 39, 4106 Therwil, Switzerland, www.sentec.com

Patient Monitor

IN ACCORDANCE WITH IEC 60601-1; ANSI/AAMI ES60601-1; CAN/CSA C22.2 No.

60601-1, IEC 60601-1-2, IEC 60601-2-23, ISO 80601-2-61.

 Contents 
 
SenTec Digital Monitoring System i 
Contents 
Contents i 
Figures ii 
Tables ii 
Abbreviations ii 
1INTRODUCTION 1 
1.1 Related Documents 2 
1.2 Safety Information 4 
2THE SENTEC DIGITAL MONITORING SYSTEM (SDMS) 11 
2.1 Components 11 
2.2 The SenTec Digital Monitor (SDM) 12 
3MAINTENANCE/SAFETY & FUNCTIONALITY TESTS 14 
3.1 SenTec TC Sensors 15 
3.2 SenTec Digital Monitor 30 
3.3 Docking Station 41 
3.4 Digital Sensor Adapter Cable 42 
3.5 Opening the Membrane Changer 43 
4TROUBLESHOOTING 44 
4.1 How to use the troubleshooting list 44 
4.2 Troubleshooting List 46 
5REPAIRS OF THE SDM 73 
5.1 Prior to Repair 74 
5.2 Replacement, Tip-up Foot 74 
5.3 Replacement, Silicon Foot 75 
5.4 Replacement, main fuses 75 
5.5 Replacement, Docking Station Door 76 
5.6 Replacement, Docking Station Gasket 77 
6SOFTWARE UPDATES 79 
7DISPOSAL 80 
7.1 SenTec Digital Monitor 80 
7.2 Cables 80 
7.3 SenTec TC Sensors 80 
7.4 Service Gas Bottle 80 
7.5 Consumables 80 
8APPENDIX 81 
8.1 Protocol for Safety & Functionality Test 81 
8.2 Testing Accessories and Spare Parts 81 
8.3 Repair or Investigation Request Form 81 
8.4 Repair Reporting Form 81 
8.5 Customer Feedback Form 81 
8.6 Instructions for Shipment 81 
8.7 Certificate for Disinfection 81 
8.8 SDMS Maintenance Checklist 82 
8.9 Interfaces - Pin Assignement 82 
8.10 Technical Specifications 86 
8.11 Contact 86 

 
 
HB-005615-j 
ii 
Figures 
Figure 1 Front Panel of the SDM 12 
Figure 2 Rear Panel of the SDM 13 
Figure 3 Removal of the Membrane from the TC Sensor 16 
Figure 4 Top view of the V-Sign™ Sensor 17 
Figure 5 Inspection after remembraning the sensor 18 
Figure 6 Examples: PCO2 and PO2 Slope Test 22 
Figure 7 Connections for the High Potential Test, AP 31 
Figure 8 Connections for the High Potential Test, PC 32 
Figure 9 Connections for the Safety Test 34 
Figure 10 Correct orientation of the Docking Station Gasket 41 
Figure 11 Opening the Membrane Changer 43 
Figure 12 Replacement, Tip-up Foot 74 
Figure 13 Replacement, Silicon Foot 75 
Figure 14 Replacement, Main Fuses 75 
Figure 15 Docking Station Door Insertion 76 
Figure 16 Replacement, Docking Station Gasket 77 
Figure 17 Positioning of the Docking Station Gasket 78 
Figure 18 Sensor Connection Port 83 
Figure 19 Serial Data Port (RS-232) 84 
Figure 20 Multipurpose I/O Port 84 
 
Tables 
Table 1 Related Documents 2 
Table 2 Components of the SDMS 11 
Table 3 Connections for the High Potential Test, AP 31 
Table 4 Connections for the High Potential Test, PC 32 
Table 5 Example of a Troubleshooting Procedure 45 
Table 6 Troubleshooting PCO2/ PO2 Monitoring 47 
Table 7 Troubleshooting SpO2/ PR Monitoring 53 
Table 8 Sensor specific troubleshooting 54 
Table 9 SDM specific troubleshooting 59 
Table 10 Docking Station specific troubleshooting 69 
Table 11 Pin Assignment, Sensor Connection Port 83 
Table 12 Pin Assignment, Serial Data Port (RS-232) 84 
Table 13 Pin Assignment, Multipurpose I/O Port 85 
 
Abbreviations 
AHP Absolute Heating Power 
CO2 Carbon dioxide 
DS Docking Station (calibration unit being integrated in the SDM) 
HP Heating Power 
HPM Heating Power Mode 
LED Light emitting diode 
MRI Magnetic Resonance Imaging 
O2 Oxygen 
PaCO2 Arterial carbon dioxide partial pressure 
PaO2 Arterial oxygen partial pressure 
PcCO2 Cutaneous carbon dioxide partial pressure (i.e. the CO2 partial pressure at the skin 
surface) 
PCO2 Used to display/label tcPCO2 on the SDM and –unless explicitely stated otherwise –
throughout this manual 
PcO2 Cutaneous oxygen partial pressure (i.e. the O2 partial pressure at the skin surface) 

SenTec Digital Monitoring System iii

PI Pulsation Index

PO2 Used to display/label tcPO2 on the SDM and –unless explicitely stated otherwise -

throughout this manual

POST Power-On Self-Test

RO Responsible Organization

PR Pulse rate

RHP Relative Heating Power

RMI Remote monitoring interrupted

SaO2 Arterial oxygen saturation

SDM SenTec Digital Monitor

SDMS SenTec Digital Monitoring System

SpO2 Functional oxygen saturation of arterial hemoglobin as measured with a pulse

oximeter

TC Transcutaneous

tcPCO2 Transcutaneous carbon dioxide partial pressure, i.e. an estimate of PaCO2 calculated

from the measured PcCO2 and displayed/labeled on the SDM and - unless explicitly

stated otherwise - throughout this manual as ‘PCO2’

tcPO2 Transcutaneous oxygen partial pressure, i.e. an estimate of PaO2 calculated from the

measured PcO2 and displayed/labeled on the SDM and - unless explicitly stated

otherwise - throughout this manual as ‘PO2’

VOM V-CareNeT™ Only Mode

1 Introduction

SenTec Digital Monitoring System

1Introduction

This Manual provides information on

maintenance and safety and functionality tests for the SenTec Digital

Monitoring System (SDMS) intended for qualified personnel only (

see

section 3

);

troubleshooting for the SDMS (

see section 4

). The troubleshooting list covers

three levels of recommended troubleshooting procedures a) for the operator,

b) for qualified personnel, and c) for SenTec authorized technicians only;

repair procedures that do not require opening the cover of the SDM intended

for qualified personnel only (

see section 5

Note:

Repairs that require opening the SDM cover are described within SenTec`s

Repair Manual for the SDMS

(which is distributed to SenTec authorized

service personnel only). Within this manual, activities described as “for

SenTec authorized service technicians only” refer to activities described in

detail within the

Repair Manual for the SDMS

(HB-005755).

This manual must be read carefully prior performing service or repairs.

Section

1.2, "Safety Information"

must be read and understood.

This Manual contains confidential information. The contents of this

document may not be reproduced in any form or communicated to any third

party without the prior written consent of SenTec AG.

1 Introduction

HB-005615-j

1.1 Related Documents

To perform service or repairs you must know how to operate the SDMS. The SDMS

consists of the SenTec Digital Monitor (SDM), sensors and accessories.

Refer to the following Manuals and Directions for Use:

Table 1 Related Documents

System

component

Manual

Content

SDMS

Manual CD

With the exception of the

Repair Manual for the SDMS

all documents listed in this Table are available on the

Manual CD.

SDMS

Quick Reference Guide

for the SDMS

Routine Use: The Q

uick Reference Guide for the SDMS

summarizes the key essentials on just 2 pages.

SDMS

Instruction Manual for

the SDMS

Getting started / Using the SDMS: The

Instruction

Manual for the SDM

S highlights the essential points

when using the SDMS. To ensure proper operation of

the SDMS, precisely follow the instructions provided in

the

Instruction Manual for the SDMS

step by step.

Contains routine checks and maintenance procedures

that can be performed by the operator.

SDM

Technical Manual for the

SDM

HB-005752

The

Technical Manual for the SDM

provides detailed

information on the SenTec Digital Monitor (SDM).

SDMS

Service Manual for the

SDMS (present manual)

Provides information on maintenance, safety and

functionality tests, troubleshooting and repair

procedures that do not require opening the cover

of the SDM as well as on service/maintenance

procedures for sensors.

SDMS

Repair Manual for the

SDMS

HB-005755

The

Repair Manual for the SDMS

covers repair

procedures on the opened SDM. The

Repair Manual

for the SDMS

is distributed to SenTec authorized

service personnel only.

Sensors /

Disposables

Respective Directions for

Use

Additional information on SenTec TC Sensors, the

Membrane Changer and Membrane Changer Insert, the

Ear Clip, the Multi-Site Attachment Rings, and SenTec’s

Staysite™ Adhesive is provided in the respective

Directions for Use.

V-STATS™

Installation Manual for

V-STATS™

This manual describes the procedures to install

V-STATS™ on a PC.

V-STATS™

Instruction Manual for

V-STATS™

The Instruction Manual for V-STATS™ provides detailed

information on V-STATS™.

1 Introduction

SenTec Digital Monitoring System

Note:

Related forms (as referenced within this manual) are listed in

section 8

“Appendix”.

Note:

The

Quick Reference Guide for the SDMS

and the

Instruction Manual for the

SDMS

in all available languages can also be downloaded from SenTec’s

Webpage (https://www.sentec.com/education/customer-portal).

Information / Instructions about the Digital Sensor Adapter Cable, the

Contact Gel and the Service Gas are provided in the

Instruction Manual for

the SDMS

and the

Technical Manual for the SDM

Note:

SDMS related tutorials are available for online viewing

at http://www.sentec.com/tv

1 Introduction

HB-005615-j

1.2 Safety Information

Warnings

This symbol identifies a WARNING statement. Warnings alert

users to potential serious outcomes (death, injury, or adverse

events) to the patient, user, or environment.

Cautions

This symbol identifies a CAUTION statement. Cautions alert

users to exercise appropriate care for safe and effective use of

the product and the care necessary to avoid damage to the

product that may occur as a result of use or misuse.

Carefully read all safety information in this Manual and in the

Technical Manual for the

SDM (HB-005752)

before operating the device or performing service/repairs.

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