Sentec SDM Service Manual

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

trademarks of SenTec AG / © 2019 SenTec AG. All rights reserved. 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. 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

1 INTRODUCTION 1

1.1 Related Documents 2

1.2 Safety Information 4

2 THE SENTEC DIGITAL MONITORING SYSTEM (SDMS) 11

2.1 Components 11

2.2 The SenTec Digital Monitor (SDM) 12

3 MAINTENANCE/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

4 TROUBLESHOOTING 44

4.1 How to use the troubleshooting list 44

4.2 Troubleshooting List 46

5 REPAIRS 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

6 SOFTWARE UPDATES 79
7 DISPOSAL 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

8 APPENDIX 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

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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

1

1 Introduction

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

2

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

3

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

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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.

1 Introduction

SenTec Digital Monitoring System

5

1.2.1 General Safety Information

WARNING: The SenTec Digital Monitoring System (SDMS) is to

be operated by qualified personnel only. Read this manual,
accessory Directions for Use, all precautionary information, and
specifications before use.

WARNING: The SenTec Digital Monitor (SDM) is not intended
for diagnosis, it is intended only as an adjunct in patient
assessment. It must be used in conjunction with clinical signs
and symptoms. The SDM is a cutaneous blood gas monitor and
not a blood gas analyzer.

WARNING: Do not use SDMs, sensors, cables, or connectors
that appear damaged.

WARNING: Carefully route and fix cables to reduce the
possibility of patient entanglement or strangulation.

WARNING: To ensure patient safety, do not place the SDM in
any position that might cause it to fall on the patient.

WARNING: Do not lift the SDM by the sensor cable or the AC
power cord because they could disconnect from the SDM,
causing the SDM to fall on the patient.

WARNING: Do not spray, pour, or spill any liquid on the SDM,
its accessories, connectors, switches, or openings in the chassis.
If the SDM has been wetted accidentally, it must be removed
from AC power, wiped dry externally, allowed to dry thoroughly,
and inspected by qualified service personnel before further use.

WARNING: Keep the SDM (as well as any discarded parts) out
of reach of children under the age of 5 years. Some parts of the
SDM are small enough to be swallowed and may block the
trachea.

WARNING: Explosion and flammability hazards. Do not use the
SDM in the presence of flammable anesthetics / gases or other
flammable substances in any environment which has increased
oxygen content.

1 Introduction

HB-005615-j

6

WARNING: The SDMS only can be used in patients undergoing
hyperbaric therapy if the SDM (monitor) remains outside the
hyperbaric environment.

WARNING: The SDM is protected against electrostatic/
defibrillator discharge. Parameter display may be temporarily
affected during discharge/ defibrillation, but will rapidly recover.
Precisely follow the instructions given in the defibrillator manual.

WARNING: This device has been tested and found to comply
with the requirements for medical devices according to the IEC
60601-1-2, and the Medical Device Directive 93/42/EEC. These
requirements are designed to provide reasonable protection
against harmful interference in a typical medical installation.

WARNING: To ensure protection of patient, operator and
equipment from the effects of defibrillation and diathermy/
electro-surgery, cables manufactured by SenTec AG must be
used.

WARNING: During normal operation (except transport), it is
recommended that the monitor is always connected to the AC
power outlet.

WARNING: Do not connect the SDM to an electrical outlet
controlled by a wall switch, because the SDM may be accidentally
turned off once the battery is depleted.

WARNING: To avoid risk of electric shock, this equipment
should be connected to a supply mains with protective earth.
Ensure that power and protective ground lines are connected
correctly. If case of doubt (e.g. as this may be the case during
home use of the SDM) disconnect the SDM from the outlet and
use the battery power during patient monitoring.

WARNING: Do not use the protective earth terminal for any
other purpose than protective earthing or functional earthing.

WARNING: For US, respectively Japan: Grounding reliability
can only be achieved when the SDM is connected to an
equivalent receptacle marked HG (Hospital Grade), respectively
HGJ (Hospital Grade Japan).

1 Introduction

SenTec Digital Monitoring System

7

WARNING: The SDM should not be used adjacent to or stacked
with other equipment as these can cause electromagnetic
interference and thereby result in incorrect measurements. If
adjacent or stacked use is necessary, the SDM should be
observed to verify normal operation in the configuration it is to
be used.

WARNING: Certain types of mobile telecommunication
equipment could potentially interfere with SDM operation. Mobile
telecommunication equipment should not be used within five
meters (16.4 feet) of the SDM. Otherwise, degradation of the
device performance could result.

WARNING: The use of accessories, sensors, and cables other
than those specified may result in increased emission and/or
decreased immunity and inaccurate readings of the SDM.

WARNING: When connecting/ mounting the SDM to accessory
equipment (e.g. PCs, PSG-Systems, (wireless) networks, roll
stands, mounting plates, incubators, etc.)), verify proper
operation before clinical use of the SDM and accessory
equipment. In certain cases it may be required that the SDM and
the accessory equipment must be connected to a grounded AC
outlet. In case of doubt consult qualified technicians.

WARNING: Accessory equipment (e.g. a PC) connected to the

SDM’s data ports must be certified according to the IEC 60950

standard. All resulting combinations of equipment must be in
compliance with the IEC standard 60601-1 systems
requirements. Anyone who connects accessory equipment to the
SDM configures a medical system and is, therefore, responsible
for ensuring that the resulting system complies with the
requirements of standard IEC 60601-1 and the electromagnetic
compatibility standard IEC 60601-1-2.

WARNING: The mains power supply of the SenTec Digital
Monitor (SDM) is separated by two Means of Patient Protection
(MOPPs) between the sensor port (for the applied part, the
sensor) and the interface connectors. The three interface
connectors - serial data port, Multipurpose I/O port (analog
outputs, nurse call), LAN port - of the SDM are not separated
from each other. If at a time accessory equipment is connected
to only one of the three interface connectors no additional safety
measures are necessary to comply with the requirements of IEC
60601-1. If however accessory equipment is simultaneously

connected to two or three of the SDM’s interface connectors

1 Introduction

HB-005615-j

8

additional safety measures may be required to be compliant with
the requirements of IEC 60601-1. In case of doubt consult
qualified technicians.

WARNING: The Roll Stand, model RS_SDM, is intended for use
with the SDM only or in combination with the Cable Cleat, model
CC_SDM, and the SDM. The mounting plates are intended for
use with the SenTec Digital Monitor (SDM) only. Do not use the
accessories for devices from other manufacturers than SenTec
together with SenTec Digital Monitoring System (SDMS).

WARNING: Do not attach the basket of the Roll Stand, model
RS_SDM, in any position that might cause it to tip over and
possibly fall on the patient. Ensure that the Roll Stand does not
tip over with and without the SDM being mounted to it.

WARNING: This warning applies to all SDMs with serial
numbers less than or equal to 302968 provided that the open
thread has not been replaced by a blind thread already or is not
sealed with slotted setscrew and thread locking adhesive. A

screw entering 17 mm (0.67 inches) into one of the SDM’s screw
holes may touch the primary part of the SDM’s power supply. If

this screw is electrically conducting the resulting short circuit
may cause an electrical isolation failure and, consequently, if the
SDM is connected to AC power an electrical shock may occur to
a person touching this screw or any other electrically conducting
material being in contact with this screw.

CAUTION: To maintain monitor readiness in-between
monitoring if using a SenTec TC Sensor:

1. ALWAYS clean the sensor before putting it into the

Docking Station!

2. ALWAYS store the clean sensor in the Docking Station!

3. ALWAYS keep the monitor switched on!

CAUTION: Do not immerse the SDM nor the connectors of any
connecting cables in liquid solution. Plugs and connectors
meticulously have to be kept clean and dry at all times.

1 Introduction

SenTec Digital Monitoring System

9

CAUTION: To ensure accurate performance and prevent device
failure, do not subject the SDM to heavy moisture, such as direct
exposure to rain. Such exposure may cause inaccurate
performance or device failure. If the SDM becomes wet
accidentally, it should be removed from AC power, wiped dry
externally, allowed to dry thoroughly, and inspected by qualified
service personnel before further use.

CAUTION: Do not sterilize any parts of the SDMS by irradiation,
steam, ethylene oxide, or H2O2 plasma.

CAUTION: Ensure that the SDM is properly grounded when
operating on AC power. If you are uncertain whether the AC
outlet is properly grounded, disconnect the SDM from the outlet
and use the battery power. Contact a qualified electrician to
examine the outlet for ground connections.

CAUTION: When installing/setting up the SDM, ensure that the
SDM can easily be disconnected from the AC power source at
any given time.

CAUTION: Use only hospital-grade power cords provided by
SenTec.

CAUTION: Ensure to always use the correct type and rating of
live and neutral fuses. Otherwise you risk damage or malfunction
of the SDM.

CAUTION: If the monitor is operated on an AC power source
with a depleted battery and the AC power is subsequently lost,
the monitor will shut down immediately.

CAUTION: Ensure that the fan of the SDM is clear of any
obstructions and that the SDM is located in a well-ventilated
dust-free atmosphere. Failure to do so could cause damage or
malfunction of the SDM.

1 Introduction

HB-005615-j

10

1.2.2 Safety Information regarding Repair and

Service Operations

WARNING: Maintenance and repair requiring removal of the

case or covers must be performed by SenTec authorized service
personnel.

WARNING: Before attempting to open or disassemble the SDM,
disconnect the device from the AC power outlet.

WARNING: Before replacing fuses of the SDM, disconnect the
device from the AC power outlet.

WARNING: Use only accessories and spare parts supplied or
recommended by SenTec AG. Do not perform other service and
repair activities than specified and described by SenTec AG.
Failure to comply may result in physical injury, inaccurate
measurements, and/or damage to the device.

WARNING: Chemicals from a broken LCD display panel are
toxic when ingested. Use caution when handling a SDM with a
broken display panel. Electronic components may content toxic
chemicals. Do not ingest chemicals from a broken electronic
component.

WARNING: Dispose of battery in accordance with local
requirements and regulations.

CAUTION: Follow ESD (Electrostatic discharge) precautions
when working with the SDM, especially when disassembling and
reassembling the SDM and when handling any of the
components. Use an ESD protective wrist-strap and table-mat
connected to Earth while working with the electronics.

CAUTION: When reassembling the SDM tighten the screws to
a torque of 5 Nm. Over-tightening could strip out the screw
holes, rendering the part unusable.

2 The SenTec Digital Monitoring System (SDMS)

SenTec Digital Monitoring System

11

2 The SenTec Digital Monitoring

System (SDMS)

2.1 Components

The SenTec Digital Monitoring System (SDMS) comprises the following main
components:

Table 2 Components of the SDMS

REF

Product

SDM

SenTec Digital Monitor (including mains power cord)
SDMs with firmware version SMB SW-V08.00/ MPB SW-V06.00 are available

with/without factory preconfigured PO2-option.

VS-A/P/N

V-Sign™ Sensor 2 (for PCO2, SpO2/PR monitoring)

OV-A/P/N

OxiVenT™ Sensor (for PCO2, PO2, SpO2/PR monitoring)

AC-YYY

Digital Sensor Adapter Cable (to connect VS-A/P/N or OV-A/P/N to SDM; YYY=150,

250, 750 cm)

EC-MI

Ear Clip (to apply SenTec TC Sensors at earlobe of patients with mature/ intact skin)

MAR-MI

Multi-Site Attachment Ring MAR-MI (to apply SenTec TC Sensors to patients with

mature/ intact skin)

MAR-SF

Multi-Site Attachment Ring MAR-SF (to apply SenTec TC Sensors to patients with

sensitive/ fragile skin)

SA-MAR

Staysite™ Adhesive for the Multi-Site Attachment Rings (attaches complementary

the MAR-SF/MI to the skin with an additional adhesive film)

GEL-04

Contact Gel (contact liquid to apply SenTec TC Sensors to the patient)

MC-R

Membrane Changer (to change the membrane of SenTec TC Sensors)

MC-I

Membrane Changer Insert (separately bagged, single-use Inserts for the MC-R)

GAS-0812

Service Gas (needed to calibrate SenTec TC Sensors)

V-STATS_CD

V-STATS™ (PC based Trend Data Download/ Analysis, Remote Monitoring, and

Configuration Software for SenTec Digital Monitors)

Note:

The components listed above do not necessarily correspond to the scope of
delivery. Please refer to SenTec’s Webpage (www.Sentec.com/products) for
additional information and other available accessories.

2 The SenTec Digital Monitoring System (SDMS)

HB-005615-j

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2.2 The SenTec Digital Monitor (SDM)

2.2.1 Front Panel

1 Trend Display Area
2 Numerical Display Area
3 Menu/ Previous Level Button
4 AUDIO PAUSED/OFF Button
5 AUDIO PAUSED/OFF Indicator (yellow LED)
6 Door Handle
7 Docking Station Door

(colored dot in center of door indicates the
SDM’s PO2 activation status: blue if
activated, orange otherwise)

8 Enter Button
9 Display Button
10 AC Power/Battery Indicator

(green/yellow LED)

11 UP/DOWN Buttons
12 ON/OFF Indicator (green LED)
13 Status Bar
14 Speaker (on the side)

Figure 1 Front Panel of the SDM

Note:

SDMs with firmware version SMB SW-V08.00/ MPB SW-V06.00 are available
with and without activated PO2-option. If the PO2-option is activated the
colored dot in the Docking Station Door of the respective SDM will be blue,
otherwise orange.

2 The SenTec Digital Monitoring System (SDMS)

SenTec Digital Monitoring System

13

2.2.2 Rear Panel

15 Sensor Connection Port
16 Multipurpose I/O-Port

(Nurse call, analog output)

17 Serial Data Port (RS-232)
18 Network Port (LAN)
19 Gas Bottle Slot

20 Fan
21 Equipotential Terminal Connector

(ground)

22 Fuse Holder
23 AC Power Connector
24 ON/OFF Switch

Figure 2 Rear Panel of the SDM

WARNING: Refer to

section 1.2.1

for warnings related to

connecting/mounting the SDM to accessory equipment.

CAUTION: Ensure to always use the correct type and rating of
live and neutral fuses. Otherwise you risk damage or malfunction
of the SDM.

CAUTION: Ensure that the fan of the SDM is clear of any
obstructions and that the SDM is located in a well-ventilated
dust-free atmosphere. Failure to do so could cause damage or
malfunction of the SDM.

3 Maintenance/Safety & Functionality Tests

HB-005615-j

14

3 Maintenance/Safety &

Functionality Tests

At normal use there is no internal adjustment or new calibration of the SDM required.
However, to guarantee continuous performance, reliability and safety of the SDMS
routine checks and maintenance procedures (including cleaning/disinfection) as well
as safety checks should be performed regularly.

Routine checks and maintenance procedures that can be performed by the operator
are provided in the

Instruction Manual for the SDMS

. Instructions for cleaning and/or
disinfecting the SenTec Digital Monitor (SDM) and the ‘Digital Sensor Adapter Cable’,
are provided in the

Technical Manual for the SDM

. Please refer to the respective
Directions for Use for instructions for cleaning and/or disinfection of SenTec TC
Sensors. For a better overview and documentation of periodic routine checks and
maintenance to be performed by the operator the SenTec form

HB-007601 “SDMS

Maintenance Checklist”

(

see section 8.7

) is available (refer to the Manual CD).

It is recommended that qualified service personnel performs the maintenance and
a complete safety and functionality test as specified in this Manual at regular intervals
(recommended every 12 month but at least every 24 months). Use the

HB-005638

“Protocol for Safety & Functionality Test” (see section 8.1 "Protocol for Safety &

Functionality Test")

to guide you through the complete "Safety & Functionality Test"

and to document your test results. To perform a complete "Safety &

Functionality Test" all tests described in this chapter MUST be performed.

Note: Prior to maintenance, service or repairs all components of the SDMS must be

cleaned and disinfected. If equipment is send to service personnel, a local
SenTec representative or to SenTec AG a completed

“Certificate for

Disinfection” (see section 8.7

) must be attached.

WARNING: If any of the tests specified below fails, the

respective problem must be fixed before the equipment is
returned to the user.

3 Maintenance/Safety & Functionality Tests

SenTec Digital Monitoring System

15

3.1 SenTec TC Sensors

Verify that the sensor has been cleaned / disinfected as described in the Directions for
Use of the sensor. If necessary remove dried up gel / electrolyte reminders with a soft
brush while immersing the (membraned) sensor into clean tap water.

3.1.1 Cleaning and Disinfection

For cleaning and disinfection procedures for the SenTec TC Sensors please refer to the
respective Directions for Use.

3.1.2 Visual Inspection

Visually inspect the sensor body, cable and membrane for damage. Check the cable
plug and its connectors for damages.

If any of the components of the sensor is irreversibly damaged, replace the sensor
with a new SenTec TC Sensor.

3.1.3 Labeling

Check presence/legibility of the serial number (label on the plug of the sensor cable).

If the serial number label is not present / legible then connect the sensor to a SDM,

switch the monitor on, read the sensor’s serial number in the menu "System
information”, and write it on the plug of the sensor cable.

3.1.4 Sensor LEDs

Connect the sensor to the SDM and switch on the monitor. Verify that the sensor emits
red light and is recognized by the SDM. When using an OxiVenT™ Sensor additionally
verify that the sensor also emits green light.

Note: In order to be able to verify the function of the green LED, pO2 must be enabled

(software option) and the pO2 parameter must be enabled (under `enabled
parameters´).

Then insert the sensor into the Docking Station. Verify that the calibration screen
activates.

If the above described functions do not operate properly refer to

section 4.2.1

“Troubleshooting PCO2 / PO2 monitoring"

to further evaluate the problem.

3.1.5 Sensor Temperature Display

Check that the measured sensor temperature (as displayed by the temperature

indicator located in the Status Bar of the SDM`s display) is within ±0.3 °C of the
currently selected ‘Sensor SET Temperature’ (e.g. as displayed in the upper right

corner of the `Ready for use´ or calibration screen: ).

3 Maintenance/Safety & Functionality Tests

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16

3.1.6 Sensor Temperature Surveillance

Note: The ‘Sensor Temperature’ Icon in the Status Bar indicates the measured sensor

temperature (in °C).

Connect the sensor to the SDM and switch on the monitor. Verify that the sensor
temperature reaches the SET temperature within 2 to 3 minutes. Then immerse the
sensor into clean tap water of 45°C - 50°C and verify that the measured sensor
temperature increases (i.e. by observing the temperature indicator located in the
Status Bar of the SDM`s display). Verify that the red sensor LED switches off, a low
priority alarm starts to sound and that the message "Temp. limiter active" (or ‘Sensor
problem 38’, ‘Sensor problem 42’) displays.

If the message “Sensor Fault xx” was triggered you must restart the SDM to reset the
message. Do not use the sensor if the message “Sensor Fault xx” is not reset by power
cycling the SDM. Instead contact qualified service personnel or your local SenTec
representative.

Do not use the sensor if the test fails!

CAUTION: Ensure that the temperature of the water bath is

< 50°C. Temperatures above 50°C may damage the sensor.

3.1.7 Cleaning / Inspecting without Membrane

1. Remove the sensor membrane using the membrane remover located at the

bottom of the Membrane Changer as shown in the figure below (note that the
Membrane Changer is shown upside down). Step : Slide the SenTec TC Sensor
into the membrane remover with its membrane facing the bottom of the
Membrane Changer. Step : Lift the SenTec TC Sensor up to remove the
membrane from the sensor body.

Figure 3 Removal of the Membrane from the TC Sensor

CAUTION: Do not touch any of the measuring units in the

center of the sensor surface after removing the sensor
membrane. Do not rub the sensor surface.

3 Maintenance/Safety & Functionality Tests

SenTec Digital Monitoring System

17

CAUTION: Do not leave the sensor without membrane in air.
Perform the following steps uninterrupted.

2. Immerse the sensor into clean, room temperature tap water for 3 minutes.

3. Use a soft brush to completely remove dried up gel / electrolyte residues from

the grooves on the sensor circumference.

4. Softly rinse the sensor with clean tap water.

5. Tap the sensor dry using a clean lint-free towel. Pay attention not to touch the

ring and the pH-glass in the center of the sensor surface. Do not rub the sensor
surface!

6. Inspect the ring around the pH-glass for damages and brownish color (

see

Figure 4 Top view of the V-Sign™ Sensor

). Note that the same criteria apply

for the OxiVenT™ Sensor.

If the ring around the pH-glass is broken, parts of it are missing, the brown color is
lost, or the ring has a metallic luster, then replace the sensor with a new SenTec TC
Sensor.

The sensor has an intact brown ring around the
pH-glass.

The ring around the pH-glass is intact but has a
metallic luster, this sensor needs to be replaced

Figure 4 Top view of the V-Sign™ Sensor

7. Inspect the sensor to ensure that the grooves on the sensor circumference are

clean and intact. If the grooves on the sensor circumference are damaged
replace the sensor with a new SenTec TC Sensor.

8. OxiVenT™ Sensor only: Verify that the white oxygen sensing spot (i.e. off-

centered, white, circular spot) is present and intact.

9. If the visual inspections (steps 6 to 8) passed remembrane the sensor using the

Membrane Changer (for instructions please refer to the Directions for Use of the
Membrane Changer).

10. After placing a new membrane, verify that

a) the membrane ring is intact and securely seated on the sensor.

b) there are no air bubbles between membrane and sensor surface.

3 Maintenance/Safety & Functionality Tests

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18

In case of loose fit, damage or trapped air you must repeat the
membrane change. Otherwise confirm the membrane change in the menu of

the monitor and calibrate sensor.

Figure 5 Inspection after remembraning the sensor

3.1.8 PCO2 / PO2 Sensitivity & Calibration Duration

WARNING: A wrong barometer reading or a gas leak can lead

to a false positive/negative test result. Prior to performing a
‘Sensitivity Test’ verify Docking Station integrity/cleanliness (

see

section 3.3 “Docking Station”

) and barometer function (

see

section 3.2.11 “Barometric Pressure”

).

Note:

If the procedure below is not strictly followed the ‘Sensitivity Test’ will abort.
Strictly observe the indicated times. ‘Sensor problem 12’ (PCO2 sensitivity)
or ‘Sensor problem 72’ (PO2 sensitivity) will only reset, if the test was

successful.

Note:

If a V-Sign™ Sensor is connected to the SDM the function ‘Sensitivity Test’
will test the sensor`s PCO2 sensitivity. If an OxiVenT™ Sensor is connected
to the SDM the function ‘Sensitivity Test’ will test the sensor`s PCO2 and

PO2 sensitivity in parallel.

Test the PCO2/PO2 sensitivity as follows:

1. Verify that the sensor SET temperature is 42°C (in case of a V-Sign™ Sensor) or

43°C (in case of an OxiVenT™ Sensor) and that the local atmospheric pressure
is at least 600 mmHg (80 kPa) (see respective icon).

Note:

You may optionally activate the display of the calibration curve by

using “V-STATS™” (PC-Software for the SDM).

2. Insert the sensor into the Docking Station.

3. Use the menu-function ‘Measurement Settings / PCO2 Settings / Sensitivity Test’

OR the menu-function ‘Measurement Settings / PO2 Settings / Sensitivity Test’ to
activate the test (both menu-functions will initiate the same test). The Status

3 Maintenance/Safety & Functionality Tests

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19

Message ‘Open DS door’ displays (accompanied by a high pitched two beep signal

tone).

4. Open the Docking Station door within 1 minute to expose the sensor to ambient

air. As soon as the door is open the Status Message changes back to ‘Sensitivity
Test’.

5. After 2 minutes the Status Message ‘Insert sensor into DS’ and the ‘Insert in DS’

- pictures appears, insert the sensor into the Docking Station within 10 minutes.

6. Once the sensor is placed in the Docking Station, the sensor will automatically

calibrate. In the Status Bar the Status Message ‘Sensitivity Test’ is displayed,
while ‘Calibration in progress’ is displayed on the screen.

7. In order to determine the calibration duration note down the time interval

between message ‘Calibration in progress’ is displayed on the screen until ‘Leak
test in progress’ (see step 8) is displayed on the screen.

8. After sensor calibration, a leak test of the Docking Station is automatically

performed. In the Status Bar the Status Message ‘Sensitivity Test’ is displayed,
while ‘Leak test in progress’ is displayed on the screen.

If the ‘Sensitivity Test’ for PCO2 failed, ‘Sensor problem 12’ will display when the sensor
is in the Docking Station and PCO2 subsequently will be flagged as invalid.

If the ‘Sensitivity Test’ for PO2 failed, ‘Sensor problem 72’ will display when the sensor
is in the Docking Station and PO2 subsequently will be flagged as invalid.

Please refer to troubleshooting P0305

(see section 4.2.1 “Troubleshooting PCO2 /

PO2 monitoring”

) before you repeat the test.

If the ‘Sensitivity Test’ passed, the Status Message ‘Ready for use’ appears.

Calibration Duration: The calibration duration should be shorter than 14 minutes. If
the calibration duration is longer than 14 minutes `PCO2 slow´or ‘Sensor problem 11’
or ‘Sensor problem 71’ is displayed. Refer to troubleshooting P0304.

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20

3.1.9 PCO2 / PO2 Slope Test

Tools:

 Sensor Tester Unit (alternatively an SDM can be used)
 V-STATS Software (optional, to enable calibration curve on SDM)
 interface online log software, e.g. “Hterm” freeware available in

the internet (optional, for easier on-line logging of calibration
values)

Note:

For a V-Sign™ Sensor only the PCO2 Slope Test must be performed. For an
OxiVenT™ Sensor both, PCO2 and PO2 Slope Test, must be performed.

Note:

The Slope Test can also be performed using a second SDM instead of a
Sensor Tester Unit. Also, a single SDM can be used (requiring changing gas
bottles after each step). If you use one single SDM, make sure that

the correct gas bottle with the correct gas concentration (with 8%
CO2, 12% O2) remains in the SDM at the end of the test.

Note:

Prior performing the Slope Test please ensure that the sensor is properly
stabilized, i.e. stored for at least 4 hours in the Docking Station with the
monitor switched on. For an overview about the Slope Test please refer to

Figure 6 Examples: PCO2 and PO2 Slope Test

.

Note:

After the test ensure to reset all parameters and settings to the ones
originally selected by your customer

1. You may optionally activate the display of the calibration curve by using “V-

STATS” (PC-Software for the SDM).

2. Verify proper function of the SenTec Sensor Tester (ST-DSU). In particular verify

the integrity of the Docking Station. Verify the expiration date of the test gas
bottles.

3. Power-cycle the SDM before starting the Slope Test (i.e. turn the SDM off and on

again to ensure that the next calibration is a so-called `Initial Calibration´, which
calibrates both, the PCO2 and PO2 channel).

4. Verify that the sensor SET temperature is 42°C or else set the sensor temperature

to 42°C (for V-Sign™ Sensor and OxiVenT™ Sensor), the ‘Severinghaus
Correction Mode’ is set to AUTO and that the local atmospheric pressure is at
least 600 mmHg (80 kPa) (see respective icon). Note down the atmospheric
pressure value. If you are using an OxiVenT™ Sensor ensure that the PO2­parameter is enabled (e.g. select Neo-mode and enable PCO2/PO2 parameters
and set sensor SET-temperature to 42°C).

5. Insert the sensor into the Docking Station of the SDM. Sensor calibration starts

automatically. If not: Use the menu-function ‘Measurement Settings / PCO2

Settings / Calibrate sensor’ to manually activate the sensor calibration (note: In
case of an OxiVenT™ Sensor this function will initiate a PCO2 and PO2

calibration). After the calibration (with 8% CO2, 12% O2) is finished please wait
6 minutes (this is to ensure that no gas leak is present in the Docking Station of
the SDM).

3 Maintenance/Safety & Functionality Tests

SenTec Digital Monitoring System

21

6. Insert the test bottle with 5% CO2 and 6% O2 into the Sensor Tester. Use the

menu-function ‘PCO2 Settings / Calibrate Sensor’ or press the ENTER Button
twice to start a calibration. Record PCO2 (5%) and PO2 (6%), i.e. the PCO2/PO2
values just before termination of the calibration. After the calibration is finished
please wait 6 minutes (this is to ensure that no gas leak is present in the Docking
Station of the SenTec Sensor Tester).

Note: If you are using an SDM for the Slope Test and in case of an OxiVenT™
Sensor the message `Sensor Problem 73´ appears on the SDM at this stage. This
is an expected behavior of the sensor.

7. Compare the measured PCO2 (5%) and PO2 (6%) with the values expected for

the respective local atmospheric pressure (see Slope Test Control Table). PCO2
(5%) should be within 5_min and 5_max. PO2 (6%) should be within 6_min and
6_max.

8. Remove the sensor from the Docking Station of the Sensor Tester, insert the

sensor into the Docking Station of the SDM and use the menu-‘PCO2 Settings /
Calibrate Sensor’ to start a calibration (with 8% CO2, 12% O2).

Note: In case of an OxiVenT™ Sensor the message `Sensor Problem 73´ will
disappear from the SDM`s display at this stage.

9. Insert the test bottle with 30% CO2 and 21% O2 into the Sensor Tester. Use the

menu-function ‘PCO2 Settings / Calibrate Sensor’ or press the ENTER Button
twice to start a calibration. Wait until calibration is finished and record PCO2
(30%) and PO2 (21%), i.e. the PCO2 value just before termination of the
calibration.

Note: If you are using an SDM for the Slope Test and in case of an OxiVenT™
Sensor the message `Sensor Problem 73´ appears on the SDM at this stage. This
is an expected behavior of the sensor.

10. Compare the measured PCO2 (30%) and PO2 (21%) with the values expected

for the respective local atmospheric pressure (see Slope Test Control Table).
PCO2 (30%) should be within 30_min and 30_max. PO2 (21%) should be within
21_min and 21_max.

11. In case of an OxiVenT™ Sensor: In order to clear the message `Sensor Problem

73´ you must do either of the following: a) power-cycle the SDM; b) connect the
OxiVenT™ Sensor to a different SDM; or c) perform a calibration with the
standard gas concentration (i.e. with 8% CO2, 12% O2).

12. If you have used one single SDM for the Slope Test, always perform a calibration

with the standard gas concentration (i.e. with 8% CO2, 12% O2) at the end of
the Slope Test.

If the readings are outside the respective limits replace the sensor and
report to SenTec the sensor behavior/replacement.

3 Maintenance/Safety & Functionality Tests

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22

Figure 6 Examples: PCO2 and PO2 Slope Test

3 Maintenance/Safety & Functionality Tests

SenTec Digital Monitoring System

23

Slope Test Control Table CO2 – in mmHg (after 5% and 30% CO2 calibration)

Pcal = value after calibration with 8%CO2.

Table is only valid for sensor temp. of 42°C.

Patm

Pcal

5_min

5_ideal

5_max

30_min

30_ideal

30_max

600

33.5

19.0

19.8

21.1

123

134

144

605

33.8

19.2

20.0

21.3

124

135

145

610

34.1

19.4

20.2

21.5

125

136

146

615

34.4

19.6

20.4

21.7

127

137

148

620

34.7

19.8

20.6

21.9

128

138

149

625

35.0

19.9

20.8

22.1

129

139

150

630

35.3

20.1

21.0

22.3

130

140

151

635

35.6

20.3

21.1

22.5

131

142

152

640

35.9

20.5

21.3

22.7

132

143

154

645

36.2

20.7

21.5

22.9

133

144

155

650

36.5

20.9

21.7

23.1

134

145

156

655

36.8

21.0

21.9

23.3

135

146

157

660

37.1

21.2

22.1

23.5

136

147

159

665

37.4

21.4

22.3

23.7

137

148

160

670

37.7

21.6

22.5

23.9

138

150

161

675

38.0

21.8

22.7

24.1

139

151

162

680

38.3

21.9

22.9

24.3

140

152

163

685

38.6

22.1

23.0

24.5

141

153

165

690

38.9

22.3

23.2

24.7

142

154

166

695

39.2

22.5

23.4

24.9

143

155

167

700

39.5

22.7

23.6

25.1

144

156

168

705

39.8

22.9

23.8

25.3

145

157

170

710

40.1

23.0

24.0

25.5

147

159

171

715

40.5

23.2

24.2

25.7

148

160

172

720

40.8

23.4

24.4

25.9

149

161

173

725

41.1

23.6

24.6

26.1

150

162

174

730

41.4

23.8

24.7

26.3

151

163

176

735

41.7

24.0

24.9

26.5

152

164

177

740

42.0

24.1

25.1

26.7

153

165

178

745

42.3

24.3

25.3

26.9

154

167

179

750

42.6

24.5

25.5

27.1

155

168

181

755

42.9

24.7

25.7

27.3

156

169

182

760

43.2

24.9

25.9

27.5

157

170

183

765

43.5

25.1

26.1

27.7

158

171

184

770

43.8

25.2

26.3

27.9

159

172

185

3 Maintenance/Safety & Functionality Tests

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24

Slope Test Control Table CO2 – in kPa (after 5% and 30% CO2 calibration)

Pcal = value after calibration with 8% CO2.

Table is only valid for sensor temp. of 42°C.

Patm

Pcal

5_min

5_ideal

5_max

30_min

30_ideal

30_max

80.0

4.46

2.54

2.64

2.81

16.4

17.8

19.2

80.7

4.50

2.56

2.67

2.84

16.6

18.0

19.3

81.3

4.54

2.58

2.69

2.86

16.7

18.1

19.5

82.0

4.58

2.61

2.72

2.89

16.9

18.3

19.7

82.7

4.62

2.63

2.74

2.92

17.0

18.4

19.8

83.3

4.66

2.66

2.77

2.94

17.1

18.6

20.0

84.0

4.71

2.68

2.79

2.97

17.3

18.7

20.2

84.7

4.75

2.71

2.82

3.00

17.4

18.9

20.3

85.3

4.79

2.73

2.84

3.02

17.6

19.0

20.5

86.0

4.83

2.76

2.87

3.05

17.7

19.2

20.6

86.7

4.87

2.78

2.89

3.08

17.9

19.3

20.8

87.3

4.91

2.80

2.92

3.10

18.0

19.5

21.0

88.0

4.95

2.83

2.95

3.13

18.1

19.6

21.1

88.7

4.99

2.85

2.97

3.16

18.3

19.8

21.3

89.3

5.03

2.88

3.00

3.18

18.4

19.9

21.5

90.0

5.07

2.90

3.02

3.21

18.6

20.1

21.6

90.7

5.11

2.93

3.05

3.24

18.7

20.2

21.8

91.3

5.15

2.95

3.07

3.26

18.8

20.4

22.0

92.0

5.19

2.98

3.10

3.29

19.0

20.5

22.1

92.7

5.23

3.00

3.12

3.32

19.1

20.7

22.3

93.3

5.27

3.02

3.15

3.34

19.3

20.8

22.4

94.0

5.31

3.05

3.17

3.37

19.4

21.0

22.6

94.7

5.35

3.07

3.20

3.40

19.5

21.1

22.8

95.3

5.39

3.10

3.22

3.42

19.7

21.3

22.9

96.0

5.43

3.12

3.25

3.45

19.8

21.5

23.1

96.7

5.47

3.15

3.27

3.48

20.0

21.6

23.3

97.3

5.51

3.17

3.30

3.50

20.1

21.8

23.4

98.0

5.55

3.19

3.32

3.53

20.2

21.9

23.6

98.7

5.60

3.22

3.35

3.56

20.4

22.1

23.7

99.3

5.64

3.24

3.38

3.58

20.5

22.2

23.9

100.0

5.68

3.27

3.40

3.61

20.7

22.4

24.1

100.7

5.72

3.29

3.43

3.64

20.8

22.5

24.2

101.3

5.76

3.32

3.45

3.66

20.9

22.7

24.4

102.0

5.80

3.34

3.48

3.69

21.1

22.8

24.6

102.7

5.84

3.37

3.50

3.72

21.2

23.0

24.7

3 Maintenance/Safety & Functionality Tests

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25

Slope Test Control Table PO2 – in mmHg (after 6% and 21% O2 calibration)

Pcal = value after calibration with 12% O2

Table is only valid for sensor temp. of 42°C.

Patm

Pcal

6_min

6_ideal

6_max

21_min

21_ideal

21_max

600

72.0

34

36

38

118

126

134

605

72.6

34

36

38

119

127

135

610

73.2

35

37

38

120

128

136

615

73.8

35

37

39

121

129

137

620

74.4

35

37

39

122

130

138

625

75.0

36

38

39

123

131

139

630

75.6

36

38

40

124

132

140

635

76.2

36

38

40

125

133

141

640

76.8

36

38

40

126

134

142

645

77.4

37

39

41

127

135

144

650

78.0

37

39

41

128

137

145

655

78.6

37

39

41

129

138

146

660

79.2

38

40

42

130

139

147

665

79.8

38

40

42

131

140

148

670

80.4

38

40

42

132

141

149

675

81.0

38

41

43

133

142

150

680

81.6

39

41

43

134

143

151

685

82.2

39

41

43

135

144

152

690

82.8

39

41

43

136

145

154

695

83.4

40

42

44

137

146

155

700

84.0

40

42

44

138

147

156

705

84.6

40

42

44

139

148

157

710

85.2

40

43

45

140

149

158

715

85.8

41

43

45

141

150

159

720

86.4

41

43

45

142

151

160

725

87.0

41

44

46

143

152

161

730

87.6

42

44

46

144

153

162

735

88.2

42

44

46

145

154

164

740

88.8

42

44

47

146

155

165

745

89.4

42

45

47

147

156

166

750

90.0

43

45

47

148

158

167

755

90.6

43

45

48

149

159

168

760

91.2

43

46

48

150

160

169

765

91.8

44

46

48

151

161

170

770

92.4

44

46

49

152

162

171

3 Maintenance/Safety & Functionality Tests

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26

Slope Test Control Table PO2 – in kPa (after 6% and 21% O2 calibration)

Pcal = value after calibration with 12% O2

Table is only valid for sensor temp. of 42°C.

Patm

Pcal

6_min

6_ideal

6_max

21_min

21_ideal

21_max

80.0

9.6

4.6

4.8

5.0

15.8

16.8

17.8

80.7

9.7

4.6

4.8

5.1

15.9

16.9

18.0

81.3

9.8

4.6

4.9

5.1

16.0

17.1

18.1

82.0

9.8

4.7

4.9

5.2

16.2

17.2

18.3

82.7

9.9

4.7

5.0

5.2

16.3

17.4

18.4

83.3

10.0

4.7

5.0

5.2

16.4

17.5

18.5

84.0

10.1

4.8

5.0

5.3

16.6

17.6

18.7

84.7

10.2

4.8

5.1

5.3

16.7

17.8

18.9

85.3

10.2

4.9

5.1

5.4

16.8

17.9

19.0

86.0

10.3

4.9

5.2

5.4

17.0

18.1

19.1

86.7

10.4

4.9

5.2

5.5

17.1

18.2

19.3

87.3

10.5

5.0

5.2

5.5

17.2

18.3

19.4

88.0

10.6

5.0

5.3

5.5

17.4

18.5

19.6

88.7

10.6

5.1

5.3

5.6

17.5

18.6

19.7

89.3

10.7

5.1

5.4

5.6

17.6

18.8

19.9

90.0

10.8

5.1

5.4

5.7

17.8

18.9

20.0

90.7

10.9

5.2

5.4

5.7

17.9

19.0

20.2

91.3

11.0

5.2

5.5

5.8

18.0

19.2

20.3

92.0

11.0

5.2

5.5

5.8

18.2

19.3

20.5

92.7

11.1

5.3

5.6

5.8

18.3

19.5

20.6

93.3

11.2

5.3

5.6

5.9

18.4

19.6

20.8

94.0

11.3

5.4

5.6

5.9

18.6

19.7

20.9

94.7

11.4

5.4

5.7

6.0

18.7

19.9

21.1

95.3

11.4

5.4

5.7

6.0

18.8

20.0

21.2

96.0

11.5

5.5

5.8

6.0

19.0

20.2

21.4

96.7

11.6

5.5

5.8

6.1

19.1

20.3

21.5

97.3

11.7

5.5

5.8

6.1

19.2

20.4

21.7

98.0

11.8

5.6

5.9

6.2

19.3

20.6

21.8

98.7

11.8

5.6

5.9

6.2

19.5

20.7

22.0

99.3

11.9

5.7

6.0

6.3

19.6

20.9

22.1

100.0

12.0

5.7

6.0

6.3

19.7

21.0

22.3

100.7

12.1

5.7

6.0

6.3

19.9

21.1

22.4

101.3

12.2

5.8

6.1

6.4

20.0

21.3

22.5

102.0

12.2

5.8

6.1

6.4

20.1

21.4

22.7

102.7

12.3

5.9

6.2

6.5

20.3

21.6

22.9

3 Maintenance/Safety & Functionality Tests

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3.1.10 Sensor Characteristics

Pressing the ‘ENTER’ Button on the SDM, while the sub-menu ‘System Information’ is
open activates a second system information screen, which displays the sensor
characteristics (for PCO2 and PO2).

3.1.11 Function Test: PCO2

/ PO2

Calibrate the TC Sensor and apply it to the ear of a healthy person: Verify, that the
PCO22 readings equilibrate (stabilize) within 2 to 10 minutes and are within 33 to 47
mmHg after stabilization.

In case of an OxiVenT™ Sensor additionally test PO2 function:

Power-cycle the SDM (i.e. switch it off and on again). Then calibrate the OxiVenT™
Sensor. After successful calibration the PO2 function test can be performed as follows:
Open the Docking Station Door in order to expose the sensor to ambient air. Then
enable the ‘Enforced Sensor On Patient Mode’ in order to start measuring PO2 (i.e. by
entering the Quick Access Menus and selecting ‘Start Monitoring’). Wait until PO2
readings equilibrate (stabilize), usually within 2 to 10 minutes. Check the atmospheric
pressure (Patm) and verify that PO2 readings are within the range shown in the tables
below. Note that PO2 ranges in the tables below are only valid for ambient
temperatures between 18°C and 28°C and relative humidity between 30% r.H. and
60% r.H.!

If these requirements are not met refer to

section 4.2.1 “Troubleshooting PCO2 / PO2

monitoring”

to further evaluate the problem.

Note:

In case of an OxiVenT™ Sensor it is recommended to check the remaining
‘Usage Time’ / ‘Life Time’. This can be done on the SDM`s `Sub-menu
System Information´ (refer to the

Technical Manual for the SDM

for further

information).

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PO2 Function Test Control Table PO2 – in mmHg and kPa

PO2 ranges are valid for ambient temperatures between 18°C and 28°C and relative
humidity between 30% r.H. and 60% r.H!

Patm
[mmHg]

ambient_
min

ambient
PO2

ambient_
max

Patm
[kPa]

ambient_
min

ambient
PO2

ambient_
max

600

116

123

130

80.0

15.4

16.4

17.4

605

117

124

131

80.7

15.6

16.6

17.5

610

118

125

133

81.3

15.7

16.7

17.7

615

119

126

134

82.0

15.9

16.9

17.8

620

120

128

135

82.7

16.0

17.0

17.9

625

121

129

136

83.3

16.1

17.1

18.1

630

122

130

137

84.0

16.3

17.3

18.2

635

123

131

138

84.7

16.4

17.4

18.4

640

124

132

139

85.3

16.6

17.6

18.5

645

125

133

140

86.0

16.7

17.7

18.6

650

126

134

141

86.7

16.8

17.8

18.8

655

127

135

142

87.3

17.0

18.0

18.9

660

128

136

143

88.0

17.1

18.1

19.1

665

129

137

144

88.7

17.3

18.3

19.2

670

130

138

145

89.3

17.4

18.4

19.3

675

132

139

146

90.0

17.5

18.5

19.5

680

133

140

147

90.7

17.7

18.7

19.6

685

134

141

148

91.3

17.8

18.8

19.8

690

135

142

149

92.0

18.0

19.0

19.9

695

136

143

150

92.7

18.1

19.1

20.0

700

137

144

151

93.3

18.2

19.2

20.2

705

138

145

152

94.0

18.4

19.4

20.3

710

139

146

153

94.7

18.5

19.5

20.5

715

140

147

154

95.3

18.6

19.6

20.6

720

141

148

156

96.0

18.8

19.8

20.7

725

142

149

157

96.7

18.9

19.9

20.9

730

143

151

158

97.3

19.1

20.1

21.0

735

144

152

159

98.0

19.2

20.2

21.2

740

145

153

160

98.7

19.3

20.3

21.3

745

146

154

161

99.3

19.5

20.5

21.4

750

147

155

162

100.0

19.6

20.6

21.6

755

148

156

163

100.7

19.8

20.8

21.7

760

149

157

164

101.3

19.9

20.9

21.8

765

150

158

165

102.0

20.0

21.0

22.0

770

151

159

166

102.7

20.2

21.2

22.1

3 Maintenance/Safety & Functionality Tests

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3.1.12 Function Test: SpO2 + PR

Apply the sensor to the earlobe of a healthy person: Compare SpO2 and PR readings
against the readings of a reference pulse oximeter (e.g. N595 with Durasensor 100
from Nellcor). The SpO2 and PR reading should be within ± 3% SpO2 and ± 3 bpm,
respectively.

If this requirement is not met refer to

section 4.2.1 “Troubleshooting SpO2 / PR

monitoring”

to further evaluate the problem.

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3.2 SenTec Digital Monitor

3.2.1 Cleaning and Disinfection

Clean or disinfect the SDM (including AC power cord) as often as required per
institutional ordinances (recommended weekly). For cleaning and disinfection
instructions refer to the

Technical Manual for the SDM

(HB-005752).

3.2.2 Visual Inspection

Visually check the entire SDM for possible damages.

If you detect a damage, the SDM needs to be repaired according to

section 5 "Repairs".

3.2.3 Labeling

Check the SDM for presence and legibility of the following labels and symbols:
Front panel: Symbols for buttons and LED’s (

see Figure 1 Front Panel of the SDM

).

Rear panel: Labels of all ports, connectors and switches; label with SN, REF and

, CE label, UL label and WEEE Disposable label (

see Figure 2 Rear

Panel of the SDM

).

If the above requirements are not met contact your local SenTec representative or
send back the monitor according to

section 8.6 "Instructions for Shipment”.

For SenTec authorized service technicians only: If the above requirements

for the front panel are not fulfilled then replace the SDM Case, upper part according
to the

Repair Manual for the SDMS

(HB-005755).

3.2.4 Electrical Safety Check

The SenTec Digital Monitoring System (SDMS) has been designed to comply with the
standards IEC 60601-1, ANSI/AAMI ES60601-1 and CAN/CSA-C22.2 No.60601-1 (UL
and cUL). To ensure electrical safety of the equipment it is recommended that
qualified service personnel performs the electrical safety check once a year (but
every two years the latest) and after repair.

The electrical safety tests for the SDMS have to be performed in accordance with the
standards IEC 60601-1, ANSI/AAMI ES60601-1 (USA) or CAN/CSA-C22.2 No.60601-1
(Canada) for instruments classified as Class 1 and Type BF (defibrillation proof).
Technicians must be familiar with these standards applicable to the institution and the
country. Test equipment and its application must comply with the applicable standard.

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31

3.2.4.1 High potential test according to IEC 60601-1

Note:

If the cover of the SDM has not been opened, this test is not required.

Tools

 AC High potential tester (e.g. Model 7530DT HypoULTRA®II

from Associated Research, Inc.)

WARNING: Before performing the high potential test read the
operating instructions of the AC High potential tester.

WARNING: Never touch the equipment under test or anything
connected to it while high voltage is applied during the high
potential test. High voltage can lead to injury or death.

The sensor is an applied part of Type BF. The interface ports of the SDM meet the
same requirements as the sensor port and are tested in an analogous manner.

The high potential test for accessible parts is performed with a voltage of 1500 VAC
during 60 seconds between the following connections of the SDM:

Table 3 Connections for the High Potential Test, AP

High Potential Test, Accessible Parts (AP)

Connection 1

Connection 2

1. Measurement

Phase connected to neutral of the AC
power cord

Equipotential Terminal

Figure 7 Connections for the High Potential Test, AP

Setup with Model 7530DT HypoULTRA®II from Associated Research, Inc.

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32

The high potential test for patient circuits is performed with a voltage of 3000 VAC
during at least 1 second between the following connections of the SDM:

Table 4 Connections for the High Potential Test, PC

High Potential Test, Patient Circuits (PC)

Connection 1

Connection 2

2. Measurement

Phase connected to neutral of the AC
power cord

Ground of the sensor connection port

3. Measurement

Phase connected to neutral of the AC
power cord

Ground of the Serial Data Port

4. Measurement

Ground of the Sensor connection port

Ground of the Serial Data Port

Figure 8 Connections for the High Potential Test, PC

Setup with Model 7530DT HypoULTRA®II from Associated Research, Inc.

If a disruptive discharge occurs refer to

section 4.2.4 "SDM specific troubleshooting"

to further evaluate the problem.

3.2.4.2 Safety test according to IEC 60601-1

Tools

 Safety analyzer for tests according to IEC 60601-1 (e.g.

601PROXL International Safety Analyzer from BIO-TEK)

If the required equipment is not available, send the SDM to your local SenTec
representative for testing.

3 Maintenance/Safety & Functionality Tests

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33

WARNING: Before performing the safety test read the
operating instructions of your safety analyzer.

WARNING: Never touch the equipment under test or anything
connected to it while high voltage is applied during the high
potential test. High voltage can lead to injury or death.

The sensor is an applied part of Type BF. The interface ports of the SDM meet the
same requirements as the sensor port and are tested in an analogous manner.

The safety test is performed according to IEC 60601-1. The following connections must
be tested (while the SDM is switched on):

 Protective Earth Resistance Test: Earth wire of the AC power cord, equipotential

terminal (ground,

see Figure 2 Rear Panel of the SDM

), gas bottle (Caution:
the container might be insulated from the thread by the color). The resistance
between two of these must be less than 0.2 Ω. Minimum current: USA = 1 A,
Europe = 5 A

 Insulation Resistance Test: AC Power Connector – housing (equipotential

terminal). The resistance must be more than 2 MΩ

 Patient Insulation Resistance: Sensor Connection Port (Ground) – housing

(equipotential terminal). The resistance must be more than 2 MΩ

 Earth Leakage Current: The current must be below 500 A
 Enclosure Leakage Current: The current must be below 100 A
 Patient Leakage Current Test: Sensor Connection Port (Ground) and interface

(Ground of the Serial Data Port) – all other connectors. The current must be
below 100 A

If the above described functions do not operate properly, the SDM needs to be
repaired. Refer to

section 4.2.4 "SDM specific troubleshooting"

to further evaluate the

problem.

Check the AC power cord for damages of the isolation. Check the connectors for
damages.

The AC power cord must be tested when connected to the AC power outlet. Thereby
the cable must be swayed to detect potential cable breaks or loose contacts. The AC
power cord must be tested together with the Ground Integrity.

If the above specifications are not met, then the AC power cord needs to be replaced
by a new AC power cord from SenTec AG, see

section 8.2 “Testing Accessories and

Spare Parts”.

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34

Figure 9 Connections for the Safety Test

Setup with 601PROXL International Safety Analyzer from BIO-TEK

3.2.5 POST

After turning on the SDM performs a power-on self-test (POST), which tests the SDM’s
circuitry and functions (internal test). The display, as well as the visual and audible
indicators (i.e. LED’s and speaker) are activated. The result of the POST is indicated
by a  (passed) or  (failed) symbol. If no problems are detected during the POST the
message ‘passed’ () is displayed; else the message ‘failed’ () is displayed.

Note: The message "FLASH Memory Inside" is displayed on the POST screen, if the
hardware version of your monitor supports a non-volatile FLASH memory.

Note: The message "LAN Interface supported" is displayed on the POST screen, if the
hardware version of the SDM supports the LAN interface.

Note: The message “LED Backlight” is displayed on the POST screen, if the backlight
is a LED type.

If the POST fails, an error message shows up at the bottom of the POST screen, refer
to P0405

(see section 4.2.4 "SDM specific troubleshooting”).

The SDM needs to be

repaired according to

section 5 "Repairs".

For SenTec authorized service technicians only: Replace the defective

parts according to the

Repair Manual for the SDMS

(HB-005755).

3 Maintenance/Safety & Functionality Tests

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35

3.2.6 Keyboard

1. Activate the Main Menu by pressing

2. Select the menu "System Settings" by going down in the menu using

3. Activate the selection by pressing

4. Select the item "Key Click" by navigating through the menu using or

5. Activate the selection by pressing once.

6. Adjust the volume of the Key Click by using the UP and DOWN Button.

When the Key Click is ON you hear a beep when pushing a button.

7. Push the Display Button twice to exit the menus.

8. If you push the AUDIO PAUSED / OFF Button the AUDIO PAUSED / OFF

Button Indicator (yellow LED) should light up (note: if the parameter “Alarm
Volume” is set to OFF pressing the AUDIO PAUSED / OFF Button has no function).

If the above described functions do not operate properly contact your local SenTec
representative or return the monitor according to

section 8.6 "Instructions for

Shipment”.

For SenTec authorized service technicians only: If the above requirements

for the Keyboard are not fulfilled then replace the SDM Case, upper part according
to the

Repair Manual for the SDMS

(HB-005755).

3.2.7 Clock Settings

Verify that the clock settings are correct. If necessary, adjust the clock in the SDM
Menu "System Settings  Date / Time".

Power cycle the SDM and control the clock settings.

If the clock settings are not correct refer to

section 4.2.4 "SDM specific

troubleshooting"

to further evaluate the problem.

For SenTec authorized service technicians only: Replace the defective

parts according to the

Repair Manual for the SDMS

(HB-005755).

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36

3.2.8 Display/LED’s

Check indicator LED’s and the display for defects:

1. Connect the SDM to AC power. Switch the SDM OFF and ON again: During the

POST, the Alarm Mute Indicator (yellow LED) and the ON/OFF Indicator (green
LED) are activated. The AC Power/Battery Indicator LED is lit yellow (battery
charging) or green (battery full). Refer to

Figure 1 Front Panel of the SDM

for location of the indicator LED’s.

2. Control the readability of the following critical areas: graph window, numerical

displays, status bar may be accepted.

If the above described functions do not operate properly contact your local SenTec
representative or send back the monitor according to

section 8.6 "Instructions for

Shipment”.

For SenTec authorized service technicians only: If the above requirements

for the LEDs are not fulfilled then replace the SDM Case, upper part according to the

Repair Manual for the SDMS

(HB-005755).

If the above requirements for the display are not fulfilled then replace the display
according the

Repair Manual for the SDMS

(HB-005755).

3 Maintenance/Safety & Functionality Tests

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37

3.2.9 Speaker (POST)

Switch ON the SDM and verify three signal tones of 0.2 seconds each during the POST.

If the speaker does not sound during the POST refer to

section 4.2.4 "SDM specific

troubleshooting"

to further evaluate the problem.

3.2.10 Fan

The fan should briefly activate during POST. The fan should rotate freely and without
causing unusual noises. The fan should rotate without obstruction when you blow into
the fan slits on the rear panel of the SDM (note that the fan needs to be off during this
test).

If the above described functions do not operate properly refer to

section 4.2.4 "SDM

specific troubleshooting"

to further evaluate the problem.

3.2.11 Barometric Pressure

Tools

 Reference Barometer

Compare the barometric pressure measured by the SDM against a calibrated reference
barometer. The barometric pressure measured by the SDM is displayed in the status
bar if PCO2 is enabled and if the sensor is in the docking station. The unit (mmHg or
kPa) depends on the setting of the menu parameter "Pressure Unit".

If the difference between the two barometric pressure readings is larger than
± 3 mmHg (0.4 kPa) the SDM has to be repaired. Refer to

section 4.2.4 "SDM specific

troubleshooting"

to further evaluate the problem.

3.2.12 Analog Output

Tools

 Multimeter
 SenTec Test Connector Multipurpose I/O

For a detailed description of the analog output refer to the

Technical Manual for the

SDM

. The analog output is part of the Multipurpose I/O Port (see

Figure 2 Rear

Panel of the SDM)

.

Measure the Analog Output voltages for the Pleth Waveform (Pin 1+2), for PR (pin
3+4), for SpO2 (Pin 5 + 6), and for PCO2 (Pin 7 + 8) using a voltmeter. To facilitate
the connection of the lead of the voltmeter to the pins, it is recommended to use the
SenTec Test Connector Multipurpose I/O (

see section 8.2 “Testing Accessories and

Spare Parts”

) or a 26 pin Mini Delta Ribbon connector (e.g. 3M part no. 10126-

3000VE).

In the menu "Interfaces / Analog Outputs" the parameter range that is attributed to
the 0 to 1 Volt output range can be changed for PCO2, SpO2, and PR. During
measurements on the patient the voltage differential varies proportionally from 0 to 1
Volt as the pin's parameter varies over the selected parameter range.

Activating the menu function "Calibration Sequence" in the menu "Interfaces / Analog
Outputs" causes for all parameters the output of 1 Volt during 60 seconds, followed
by the output of 0 Volt during another 60 seconds. When the calibration sequence is
running the current output voltage is indicated on the display.

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38

Note: By pressing ENTER it is possible

a) to change from 1 Volt to 0 Volt (if output of 1 Volt is active)
b) to stop the calibration sequence (if output of 0 Volt is active)

If the above described functions do not operate properly, the SDM needs to be
repaired. Refer to

section 4.2.4 "SDM specific troubleshooting"

to further evaluate the

problem.

3.2.13 Serial Data Port (RS-232)

For a detailed description of the Serial Data Port (RS-232) refer to the corresponding
section of the

Technical Manual for the SDM

. The Serial Data Port is located on the

rear panel of the SDM (

see Figure 2 Rear Panel of the SDM

).

To verify the data transmission to an external device (e.g. PC) activate the protocol
"SenTecLink" (proceed as described in the

Technical Manual for the SDM)

.

Connect one end of a serial cable to the serial data port (RS-232) of the SDM and
connect the other end of the cable to a serial port of your PC. If your computer has no
serial port but USB-ports an USB232 Converter Cable can be used.

Start V-STATS software on your PC. Select the appropriate COM-port in the Sub-menu

"Communication / Settings … "). Start the sub-menu “Communication / with SDM (via
Serial Interface) …”, this opens dialog “Communication with SDM (via Serial Interface)”
with the “Connection Status” indicator showing the status of the communication

between V-STATS™ and the SDM (for detail description see

V-STATS Instruction

Manual

).

Verify that data transmission between V-STATS™ and the SDM works properly. The
“Connection Status” indicator lights green if the connection is established and the
communication is successful between V-STATS™ and SDM.

If the above described functions do not operate properly, the SDM needs to be
repaired. Refer to

section 4.2.4 "SDM specific troubleshooting"

to further evaluate the

problem.

3.2.14 LAN Test

In order to test correct LAN communication the following steps need to be
performed:

 You will need a network environment to plug in your PC running a registered

V-STATS™ and the SDM. Alternatively you may use a crossover LAN cable and
connect the PC and SDM. Attach PC and SDM to the network.
Note: Please consult the online help of V-STATS™ for further information.

 Configure the SDM and connect the SDM to the PC via serial cable .
 Run V-STATS™ (latest version) and open the dialog-window “Communication with

SDM (via Serial Interface)…” by clicking on the respective big button in the center

main window or on the icon in the upper menu-bar of the graphic window or by
using the menu “Communication / with SDM (via Serial Interface) …”

3 Maintenance/Safety & Functionality Tests

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39

 Activate/check LAN link: Click on the control ‘Profiles / SDM settings’ and select

‘Interfaces’ tab of Current SDM Profile. Verify that ‘LAN selectable’ is checked and
that ‘LAN’ is set to ‘On’. Also select appropriate setting for ‘DHCP mode’, depending
on your network configuration (set to ‘Off’ in case of direct connection with
crossover cable). Enter IP address when DHCP mode was set to ‘Off’. Normally the

other settings can be left at their defaults.

 Close ‘Profiles / SDM settings’ window.
 On the SDM: navigate to menu Interfaces  LAN interface. If in DHCP mode you

should now see the IP address assigned by the DHCP server.

 With V-STATS™: Using the trial mode of V-CareNeT™ start a remote monitoring

session with the SMD.

 Note: consult online help if you need specific help on how to start the

communication.

 Verify that a green icon is shown in the V-CareNeT™ Control Window for the

connection status of the SDM (LAN test 1).

 After admitting a patient: The Remote Monitoring Window is shown, click in the

black data field and open the Additional Data window.

 Verify that the time displayed in the status bar of the window corresponds to the

time of the SDM (lagging no more than 5 seconds) and that the serial number in
the Monitor Configuration / Status Information field corresponds to the serial
number of the device under test (LAN test 2).

3.2.15 Capacity of Rechargeable Lithium Battery

Tools

 A PC with a terminal emulation software

Test using a PC:

1. Connect the SDM to AC power and wait until the battery is completely charged.

(AC Power/Battery Indicator on the front panel of the SDM (

see Figure 1

) lits

green).

2. Adjust the brightness in the menu "Systems Settings / Display Settings" to 100%.

3. Activate the communication protocol "SenTecLink" in the menu "Interfaces /

Serial Interfaces".

4. Connect the Serial Data Port (RS-232) of the SDM to an external PC and record

the on-line data using a terminal program.

5. Activate data recording using a terminal program and disconnect the SDM from

AC power.

6. When the battery capacity is below 10% the status message "Battery Low"

displays and the status code "LB" is recorded. Once the remaining battery is

critical the message “Battery critical” displays and the status code “BC” is output.

The time stamp of the last data set recorded on the PC corresponds to the time
when the battery was empty and the SDM switched off automatically. With the
first and last time stamps of the recorded data set you can calculate the running
time.

3 Maintenance/Safety & Functionality Tests

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In case of a SDM with a display with ‘CCFL Backlight’ a new, fully charged battery
provides approximately 6 hours of monitoring time (if SLEEP MODE = OFF) and
approximately 13 hours (if SLEEP MODE = ON).

In case of a SDM with a display with ‘LED Backlight’ a new, fully charged battery provides
approximately 11 hours of monitoring time (if SLEEP MODE = OFF) and approximately
16 hours (if SLEEP MODE = ON).

Note: The message ‘LED Backlight’ displays on the POST screen (

see section 3.2.5

POST) and in the sub-menu “System Settings / Display Settings” if the display of
your SDM uses an ‘LED Backlight’.

If the above described functions do not operate properly, the SDM needs to be
repaired. Refer to

section 4.2.4 "SDM specific troubleshooting"

to further evaluate the

problem.

3.2.16 Display, Alarm

Initiate a low priority alarm (e.g. by disconnecting the SenTec TC Sensor from the
SDM). Verify that the corresponding status message is displayed in the status bar.

If the above described functions do not operate properly, the SDM needs to be
repaired. Refer to

section 4.2.4 "SDM specific troubleshooting"

to further evaluate the

problem.

3.2.17 Speaker, Alarm

Initiate a low priority alarm (e.g. by disconnecting the SenTec TC Sensor from the
SDM). Verify that the audible component of a low priority alarm is audible (one burst
of two pulses (1 dyad) repeated every 15 seconds).

If the above described functions do not operate properly, the SDM needs to be
repaired. Refer to

section 4.2.4 "SDM specific troubleshooting"

to further evaluate the

problem.

3.2.18 Nurse Call, Alarm

Tools

 SenTec Test Connector Multipurpose I/O

Verify that the menu parameter ‘Interfaces / Nurse Call’ is set to ON. Then initiate a

low priority alarm (e.g. by disconnecting the SenTec TC Sensor from the SDM during
a monitoring session). The Nurse Call feature is relay-based and can be tested with
the SenTec Test Connector Multipurpose I/O,

see section 8.2 “Testing Accessories and

Spare Parts”.

Note: The nurse call function is not active if the auditory alarm signals of the SDM

are paused or permanently switched off.

If the above described functions do not operate properly, the SDM needs to be
repaired. Refer to

section 4.2.4 "SDM specific troubleshooting"

to further evaluate the

problem.

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3.3 Docking Station

3.3.1 Cleaning and Disinfection

Clean or disinfect the Docking Station (including the Docking Station gasket) as often
as required per institutional ordinances (recommended weekly) using a cotton swab
moistened with 70% isopropanol.

3.3.2 Visual Inspection

Inspect the Docking Station door and the gasket for mechanical damages. The closing
mechanism must lock properly.

If you detect a possible damage, replace the defective part according to

section

5 "Repairs".

Note: We recommend changing the gasket of the Docking Station annually.

Figure 10 Correct orientation of the Docking Station Gasket

3.3.3 Gas Level Indicator

Tools

 Full

Service Gas

bottle

Check the functionality of the gas level indicator using a new gas bottle.

1. Screw in a new gas bottle and switch the SDM ON.

2. Insert the sensor in the Docking Station and verify that the "100% gas icon"

displays in the status bar.

3. Remove the gas bottle from the SDM and verify that the yellow "0% gas icon"

displays in the status bar.

If the expected result is not observed, refer to

section 4.2.4 "SDM specific

troubleshooting"

to further evaluate the problem.

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3.4 Digital Sensor Adapter Cable

3.4.1 Cleaning and Disinfection

Clean or disinfect the `Digital Adapter Cable´ as often as required per institutional
ordinances (recommended weekly). For cleaning and disinfection instructions refer to
the

Technical Manual for the SDM

(HB-005752).

3.4.2 Visual Inspection

Check the Digital Sensor Adapter Cable for damages of the isolation. Check the Digital
Sensor Adapter Cable connectors for damages.

If you detect damages, the Digital Sensor Adapter Cable needs to be replaced by a
new Digital Sensor Adapter Cable.

3 Maintenance/Safety & Functionality Tests

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3.5 Opening the Membrane Changer

If the sensor is blocked within the Membrane Changer at any position, it can be opened
as follows:

Identify the 6 latches holding together top and bottom part of the Membrane Changer
together (see Figure 11 Opening the Membrane Changer). Insert a screwdriver
behind the latches and use it as leverage to break out the 6 latches.

WARNING: Wear protective goggles while breaking out the 6
latches.

CAUTION: This procedure will irreversibly destroy the
Membrane Changer, but not harm the sensor if executed with
care.

latches

removed
latches

Figure 11 Opening the Membrane Changer

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4 Troubleshooting

This section describes problems, possible causes and recommended corrective actions.
Repairs (without having to open the SDM cover) are described in

section 5 "Repairs"

.
Repairs that require opening the cover of the SDM are to be performed by SenTec
authorized service technicians only and are described in detail within the

Repair

Manual

.

Prior to maintenance, service or repairs all components of the SDMS must be cleaned
and disinfected. If equipment is send to service personnel, a local SenTec
representative or to SenTec AG a completed

“Certificate for Disinfection” (see section

8.7

) must be attached.

If you need to return devices for service or repair follow the shipment instructions in

section 8.6 “Instructions for Shipment”.

Send defective parts together with the completed

"Repair or Investigation Request

Form"

to your local SenTec representative. The

"Repair or Investigation Request Form"

may be copied from

section 8.3 “Repair or Investigation Request Form”.

4.1 How to use the troubleshooting list

The troubleshooting list describes possible defects of the device. The problems are
numbered (PXXXX) unambiguously. Please reference the respective PXXXX code
whenever applicable.

The trouble shooting list comprises up to three levels of recommended actions to be
performed

[1] by the operator (shaded in dark grey) and, if the problem persists,
[2] by a qualified technician (shaded in light grey), i.e. troubleshooting at

service level (according to this manual) and, if the problem persists,

[3] by SenTec authorized service technicians only (no shading), i.e.

troubleshooting at repair level (according to the

Repair Manual

).

Note:

Take into account that the operator might not have performed the corrective
actions recommended at operator-level and/or might not have identified the
problem correctly. Therefore, check other possible causes and problems.

The example in

Table 5 Example of a Troubleshooting Procedure

explains how to

work with the troubleshooting list.

4 Troubleshooting

SenTec Digital Monitoring System

45

Table 5 Example of a Troubleshooting Procedure

Problem

Possible cause

Recommended action(s)

Trouble
shooting level

P0XXX

PCO2

too low

Wrong/instable
barometric pressure
during calibration

Verify that the barometric pressure reading of the
SDM is stable during calibration and does not
deviate from a known calibrated reference
barometer by more than 5 mmHg (0.7 kPa).

Otherwise contact qualified service personnel.

a

(operator)

SDM defective

If problem persists contact SenTec authorized
service personnel.

b

(qualified

technician)

MPB
(Multiparameterboard,
SM1A) defective

Replace MPB according to section 5.16.

To be performed by SenTec

authorized service technicians only.

c

(SenTec

authorized

technician)

PCO2 sensitivity of the
sensor too low

Test the PCO2 sensitivity (see section 3.1.8 PCO2
/ PO2 Sensitivity & Calibration Duration).

If the test is not passed, remembrane the sensor
and repeat the test.

After a renewed missing of this difference, consult
qualified service personnel.

a

(operator)

Clean the sensor as described in section 3.1.7
Cleaning / Inspecting without Membrane and
perform the `Sensitivity Test´ as described in
section 3.1.8.

If problem persists contact SenTec authorized
service personnel.

b

(qualified

technician)

SenTec TC Sensor
defective

If problem persists the sensor is defective. Replace
it by original replacement parts.

To be performed by SenTec

authorized service technicians only.

c

(SenTec

authorized

technician)

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46

4.2 Troubleshooting List

This section describes problems, possible causes and recommended actions for
troubleshooting.

Note:

Shadings in the troubleshooting table reflect different levels of
recommended actions, i.e. for the operator (dark grey), qualified service
personnel (light grey) and SenTec authorized service technicians (no
shading),

see section 4.1 “How to use the troubleshooting list”

for details.

4.2.1 Troubleshooting PCO2 / PO2 monitoring

When comparing PCO2/ PO2 values displayed by the SDM with PaCO2/ PaO2 values
obtained from arterial blood gas (ABG) analysis, pay attention to the following
points:

 Carefully draw and handle blood samples.
 Blood sampling should be performed in steady state conditions.
 The PaCO2/ PaO2 value obtained from ABG analysis should be compared to the

SDM’s PCO2/ PO2 reading at the time of blood sampling.

 In patients with functional shunts, the sensor application site and the arterial

sampling site should be on the same side of the shunt.

 If the menu-parameter ‘Severinghaus Correction Mode’ is set to ‘Auto’, the PCO2

values displayed by the SDM are automatically corrected to 37 °C (regardless of

the patient’s core temperature). When performing the ABG analysis, be sure to
properly enter the patient’s core temperature into the blood gas analyzer. Use
the blood gas analyzer’s ‘37°C-PaCO2’ value to compare with the SDM’s PCO2

value.

 Verify proper operation of the blood gas analyzer. Periodically compare the blood

gas analyzer’s barometric pressure against a known calibrated reference

barometer.

Note: This section only is applicable for SenTec TC Sensors with PCO2 and/ or PO2

enabled.

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47

Table 6 Troubleshooting PCO2/ PO2 Monitoring

Problem

Possible Cause(s)

Recommended corrective action(s)

P0100

After sensor
application or

a ‘TC artifact’

PCO2 values
increase
slowly or PO2
values
decrease
slowly or do
not stabilize
within 10
minutes

Sensor loosely
attached to patient
(air between sensor
and skin; no
contact liquid)

Verify that the sensor is securely attached
and ensure that air gaps are eliminated
between the skin and the sensor. If needed,
reapply the sensor (on same or an alternate
site). For instructions refer to the

Quick

Reference Guide for the SDMS

or the

Instruction Manual for the SDMS

.

Consider to use the Staysite™ Adhesive
(model SA-MAR) to complementary attach
Multi-Site Attachment Rings if more secure
sensor attachment is required, e.g. in high
humidity environments, for patients who
perspire profusely and/or in challenging
patient motion conditions.

Note: Typically PaCO2 is > 25 mmHg in
humans and PCO2 of ambient air < 0.5
mmHg. If the contact between the sensor
and skin is not hermetically sealed PCO2
readings, consequently, may increase slowly

after sensor application or a ‘TC artifact’ and

be too low thereafter.
Note: Typically PaO2 is < 100 mmHg in

humans and PO2 of ambient air > 130
mmHg. If the contact between the sensor
and skin is not hermetically sealed PO2
readings, consequently, may decrease slowly

after sensor application or a ‘TC artifact’ and

be too high thereafter.

Note: Also refer to Status Messages ‘Check
sensor application’, ‘PCO2 stabilizing’, ‘PO2
stabilizing’, or ‘PCO2/ PO2 stabilizing’ (refer to

the

Technical Manual for the SDM

).

Sensor applied to a
measurement site
that is inadequate /
not recommended
for PCO2/ PO2
monitoring

Apply sensor to a recommended
measurement site with an appropriate Sensor
Attachment Accessory. For instructions refer
to the

Quick Reference Guide for the SDMS

or the

Instruction Manual for the SDMS

.

Excessive use of
contact liquid

Remove sensor. Clean sensor and
measurement site with an alcohol pad.
Reapply the sensor using only one drop of
contact liquid.

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48

Problem

Possible Cause(s)

Recommended corrective action(s)

PCO2 and/ or PO2
part of the sensor
is slow

Refer to P0304

P0101

PCO2 too low

OR

PO2 too high

Sensor loosely
attached to patient
(air between sensor
and skin; no
contact liquid)

Refer to identical ‘Possible Cause’ in P0100

for recommended corrective action(s)

Sensor applied to a
measurement site
that is inadequate/
not recommended
for PCO2/ PO2
monitoring

Refer to identical ‘Possible Cause’ in P0100
for recommended corrective action(s)

Arterio-venous
shunts, e.g. ductus
arteriosus.

Ensure that the sensor site and thee arterial
sampling site are on the same side of the
shunt

PCO2 part of the
sensor unstable
(causing drift)

Allow the sensor to stabilize for an additional
1 – 2 hours, i.e. store the sensor in the
Docking Station with the monitor being
switched on (refer to the

Technical Manual

for the SDM

for additional sensor stabilization

related information).
Note: After switching-on the monitor or after

membrane change, it is recommended to
store the sensor in the Docking Station with
the monitor being switched on for the
duration indicated by the yellow information

message ‘Recommended Sensor Stabilization
[min]: on’ the “Ready for use” screen and on
the “Calibration” screen (see

Technical

Manual for the SDM

).

Wrong / expired
calibration gas was
used during last
calibration

Verify that SenTec Service Gas is used. If
expired replace with a new gas bottle!

Wrong / unstable
barometric pressure
during last
calibration

Refer to P0408

PCO2 and or PO2
sensitivity of the
sensor low/
deterioriated

Refer to P0305

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49

Problem

Possible Cause(s)

Recommended corrective action(s)

PO2 Measurement
is influenced by
high ambient light
levels

Shield SenTec TC Sensor from strong
ambient light.

Note: Refer to Status Message ‘High ambient
light’ (with Status Code ‘SA’).

Clean/Inspect the sensor as described in

section 3.1.7 “Cleaning / Inspecting without
Membrane”

and perform the ‘Sensitivity Test’

as described in

section 3.1.8 “PCO2 / PO2

Sensitivity & Calibration Duration

”.

If problem persists contact SenTec authorized
service personnel.

Significant PCO2
drift

Verify that the sensor is not affected by loose
fit of the membrane, trapped air under the
membrane. If needed perform an
unrequested membrane exchange (activate

the menu “Membrane Change”). After

membrane exchange calibrate the sensor and
allow the PCO2 part of the sensor to stabilize
for 4 hours.

If no remembraning is needed allow the
sensor to stabilize for an additional 2 – 3
hours.

SDM defective

Contact SenTec authorized service personnel
or our local SenTec sales representative.

MPB
(Multiparameter­board, SM1A)
defective

Replace MPB according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SenTec TC Sensor
defective

Perform the PCO2 Slope Test according to

section 3.1.9 “PCO2 / PO2 Sensitivity &
Calibration Duration”

. If the PCO2 slope test

fails replace sensor.

To be performed by SenTec authorized

service technicians only.

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50

Problem

Possible Cause(s)

Recommended corrective action(s)

P0102

PCO2 too
high

OR

PO2 too low

Low perfusion at
the (hypoperfused)
measurement site

Limitation of the method. Evaluate the
patient status. Shock, low cardiac
index,hypothermia and inadequate local
vasodilatation are physiological limitations of
the method. Avoid any mechanical pressure /
stress on the measurement site. Verify that
the sensor temperature is appropriately
selected for the specific patient/ skin
condition at the measurement site and the
enabled parameters. When selecting/
increasing sensor temperature carefully
balance benefit (more accurate
measurements) versus risk (potential skin

burns). Carefully read the section “Sensor

Temperature & Site Timer” in the

Technical

Manual for the SDM

.

Remember: In most patients PO2
monitoring requires higher temperatures than
PCO2 monitoring. In newborns, PO2
correlates with PaO2 almost in a one to one
relationship at a sensor temperature of 43 to
44 °C, whereby the accuracy of PO2
compared to PaO2 is best up to PaO2 = 80
mmHg (10.67 kPa), above which it
increasingly tends to read lower than PaO2
(especially in adults).

Sensor applied to a
measurement site
that is inadequate /
not recommended
for PCO2
monitoring.

Refer to identical ‘Possible Cause’ in P0100

for recommended corrective action(s)

Arterio-venous
shunts, e.g. ductus
arteriosus.

Ensure that the sensor site and thee arterial
sampling site are on the same side of the
shunt

Presence of
hyperoxemia (PaO2
> 100 mmHg)

Remember: In newborns, PO2 correlates
with PaO2 almost in a one to one relationship
at a sensor temperature of 43 to 44 °C,
whereby the accuracy of PO2 compared to
PaO2 is best up to PaO2 = 80 mmHg (10.67
kPa), above which it increasingly tends to
read lower than PaO2 (especially in adults).

PCO2 part of the
sensor unstable
(causing drift)

Refer to identical ‘Possible Cause’ in P0101

for recommended corrective action(s)

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51

Problem

Possible Cause(s)

Recommended corrective action(s)

Wrong / expired
calibration gas was
used during last
calibration

Refer to identical ‘Possible Cause’ in P0101

for recommended corrective action(s)

Wrong / unstable
barometric pressure
during last
calibration

Refer to P0408
Undetected gas
leak in Docking
Station.

Refer to P0502

PCO2 and or PO2
sensitivity of the
sensor low/
deteriorated

Refer to P0305

PO2 Measurement
is influenced by
high ambient light
levels

Shield SenTec TC Sensor from strong
ambient light.

Note: Refer to Status Message ‘High ambient
light’ (with Status Code ‘SA’) (see

Technical

Manual for the SDM

).

Clean/Inspect the sensor as described in

section 3.1.7 “Cleaning / Inspecting without
Membrane”

and perform the ‘Sensitivity Test’

as described in

section 3.1.8 “PCO2 / PO2

Sensitivity & Calibration Duration

”.

If problem persists contact SenTec authorized
service personnel.

Docking Station
door mechanically
defective

Replace Docking Station door according to

section 5.5 “Replacement, Docking Station
Door”

.

Gasket defective

Replace gasket according to

section 5.6

“Replacement, Docking Station Gasket”

.

SDM defective

Contact SenTec authorized service personnel
or our local SenTec sales representative.

Calibration Module
defective

Replace Calibration Module according to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Docking Station
Module defective

Replace Calibration Module according to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

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Problem

Possible Cause(s)

Recommended corrective action(s)

P0103

PCO2 and/ or
PO2 suddenly
change /
change very

fast (‘TC
artifact’)

Sensor loosely
attached to patient
(air between sensor
and skin; no
contact liquid)

Refer to identical ‘Possible Cause’ in P0100

for recommended corrective action(s)

Adhesive pad of Ear
Clip / Multi-Site
Attachment Ring
does not stick any
more

Reapply the sensor with a new Ear Clip /
Multi-Site Attachment Ring. Pay attention not
to wet the adhesive. For instructions refer to
the

Quick Reference Guide for the SDMS

or

the

Instruction Manual for the SDMS

.

Consider to use the Staysite™ Adhesive
(model SA-MAR) to complementary attach
Multi-Site Attachment Rings if more secure
sensor attachment is required, e.g. in high
humidity environments, for patients who
perspire profusely and/or in challenging
patient motion conditions.

Electrocautery, HF
surgery,
defibrillation
(mainly PCO2
specific)

The values will come back to normal after
electrocautery, HF surgery or defibrillation.

P0104

PCO2 and/ or
PO2 changes
very slowly

Sensor applied to a
measurement site
that is inadequate /
not recommended
for PCO2
monitoring.

Refer to identical ‘Possible Cause’ in P0100

for recommended corrective action(s)

Excessive use of
contact liquid

Refer to identical ‘Possible Cause’ in P0100

for recommended corrective action(s)

PCO2 and/ or PO2
part of the sensor
is slow

Refer to P0304.

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53

4.2.2 Troubleshooting SpO2 / PR monitoring

Note:

This section is applicable for SenTec TC Sensors (if SpO2 / PR are
enabled) and for SenTec’s oximetry sensors.

Table 7 Troubleshooting SpO2/ PR Monitoring

Problem

Possible Cause(s)

Recommended action(s)

P0200

SpO2 and /
or PR too low
or too high

Venous pooling
(e.g. Trendelenburg
position)

Limitation of the method. For placement of
the sensor on the earlobe, forehead or cheek:
avoid conditions where the head is positioned
lower than the heart.

Some
cardiovascular
pathologies (e.g.
causing cardiac
arrhythmias)

Limitation of the method.

Inadequate local
blood flow at the
measurement site

Evaluate the patient status. Shock, low
cardiac index, inadequate local vasodilatation
are physiological limitations of the method.

Verify the sensor application and the
appropriateness of the monitoring site.

Avoid any mechanical pressure / stress on the
sensor or measurement site. Secure the
sensor cable with adhesive tape and a
clothing clip

Note: Refer to the Status Message ‘SpO2 low
signal’ (see

Technical Manual for the SDM

).

Electrocautery, HF
surgery,
defibrillation

The values will come back to normal after
electro-cautery, HF surgery or defibrillation.

Sensor applied to a
measurement site
that is inadequate /
not recommended
for SpO2
monitoring.

Apply sensor to a measurement site
recommended/ approved for SpO2/ PR
monitoring with an appropriate Sensor
Attachment Accessory. For instructions refer
to the

Quick Reference Guide for the SDMS

or

the

Instruction Manual for the SDMS

.

Artifacts due to
patient movements

Verify the sensor application and the
appropriateness of the monitoring site.
Secure the sensor cable with adhesive tape
and a clothing clip.

Note: Refer to the Status Message ‘SpO2
signal quality’ (see

Technical Manual for the

SDM

).

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Problem

Possible Cause(s)

Recommended action(s)

SpO2/ PR
Measurement is
influenced by high
ambient light levels

Shield SenTec TC Sensor from strong ambient
light (e.g. lamps).

Note: Refer to Status Message ‘High ambient
light’ (with Status Code ‘HA’) (see

Technical

Manual for the SDM

).

Dysfunctional
hemoglobin

Physiological limitation of the method. In
patients with high carboxyhemoglobin levels
(e.g. smokers) functional saturation
measured with a pulse oximeter will
overestimate functional saturation determined
with a CO-oximeter.

Excessive use of
contact liquid
causing light
shunting

Remove the SenTec TC Sensor. Clean sensor
and measurement site with an alcohol pad.
Reapply the sensor using only one drop of
contact liquid.

Intravascular dyes

Limitation of the method. Dyes used as
tracer, contrast medium, etc. may absorb
light at the same wavelength as the one used
for pulse oximetry measurements.

4.2.3 Sensor specific troubleshooting

Table 8 Sensor specific troubleshooting

Problem

Possible Cause(s)

Recommended action(s)

P0300

Despite a
SenTec TC
Sensor is
connected to
the SDM the
message

‘Connect
sensor’

displays

Bad contact (cables
not properly
connected)

Verify connections (disconnect and reconnect
all cables) and – if necessary – power cycle
the SDM.

SenTec TC Sensor
and / or ‘Digital
Sensor Adapter
Cable’ defective

To identify the defective part, exchange the
‘Digital Sensor Adapter Cable’ or the SenTec
TC Sensor and try again (if necessary
permute and try on a different SDM).

In case of damage of the SenTec TC Sensor
replace it by original replacement parts.

In case of damage of the ‘Digital Sensor
Adapter Cable’ replace it by original

replacement parts.

SDM defective

If problem persists contact qualified service
personnel.

SDM defective

Refer to

section 4.2.4 “SDM specific

troubleshooting

” to further evaluate the

problem.

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55

Problem

Possible Cause(s)

Recommended action(s)

P0301

Despite
oximetry
sensor is
connected to
the SDM the
message

‘Connect
sensor’

displays

Bad contact (cables
not properly
connected)

Verify connections (disconnect and reconnect
all cables) and – if necessary – power cycle
the SDM.

Oximetry sensor
and / or ‘SpO2
Adapter Cable’
defective

To identify the defective part, exchange the

‘SpO2 Adapter Cable’ or the oximetry sensor

and try again (if necessary permute and try
on a different SDM).

In case of damage of the oximetry sensor
replace it by original replacement parts.

In case of damage of the ‘SpO2 Adapter
Cable’ replace it by original replacement

parts.

SDM defective

If problem persists contact qualified service
personnel.

SDM defective

Refer to

section 4.2.4 “SDM specific

troubleshooting

” to further evaluate the

problem.

P0302

Sensor’s red

LED does not
light
(message

‘Connect
sensor’ not

displayed)

As a safety
precaution sensor
or SDM did switch
off all power
consuming parts

Refer to Status Messages ‘Temp. limiter
active’, ‘Sensor problem 38’, ‘Sensor problem
42’, ‘Sensor fault 39’, ‘Sensor fault 43’ (see

Technical Manual for the SDM

).

Red LED defective

Refer to messages ‘Sensor problem 20’,
‘Sensor fault 20’ and ‘Sensor fault 21’ (see

Technical Manual for the SDM

).

P0303

Message

‘Sensor
problem 10’

Membrane related
(no or defective
membrane)

Membrane the sensor if membrane is
missing. Change the membrane if it is
damaged, has a loose fit, or if there is
trapped air or dry electrolyte under the
membrane.

Wrong / expired
calibration gas was
used during last
calibration

Verify that SenTec Service Gas is used.
If expired replace with a new gas bottle!

Substantial gas leak
in Docking Station

Refer to P0502

Note: In this situation the message ‘Gas leak
in DS’ would not display as ‘Sensor problem
10’ has a higher internal rank.

PCO2 electrode
contaminated

If after having changed the sensor membrane
the problem persists contact qualified service
personnel.

4 Troubleshooting

HB-005615-j

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Problem

Possible Cause(s)

Recommended action(s)

Clean the sensor as described in

section 3.1.7

“Cleaning / Inspecting without Membrane”.

Then calibrate the sensor.

SenTec TC Sensor
defective

If the problem persists the SenTec TC Sensor
is defect. Replace it with a new one.

Calibration Module
defective

Replace the Calibration Module according to
the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SDM defective

Refer to

section 4.2.4 “SDM specific

troubleshooting

” to further evaluate the

problem.

P0304

PCO2 slow
(too slow) /
Message

‘Sensor

problem 11,
14’

OR

PO2 slow
(too slow) /
Message

‘Sensor
problem 74’

Membrane related
(defective or dried
up electrolyte)

Change the membrane :

- if it is damaged or missing, has a loose fit,

or if there is trapped air or dry electrolyte
under the membrane

- sensor calibration takes almost 14

minutes or cannot be completed within 14
minutes

Note: If the PCO2 calibration takes 14

minutes the message ‘PCO2 slow’ displays

and PCO2 subsequently will be flagged as
questionable.

Note: If the PCO2 calibration cannot be
finished within 14 minutes the message

‘Sensor problem 11’ displays and PCO2

subsequently will be flagged as invalid.
Note: If the calibration cannot be finished

within approx. 30 minutes – due to failed
extended calibration – the message ‘Sensor

problem 14’ displays and PCO2 subsequently

will be flagged as invalid.
Note: If the PO2 calibration cannot be

finished within 14 minutes the message

‘Sensor problem 74’ displays and PO2

subsequently will be flagged as invalid.

PCO2 electrode
and/ or white PO2
sensing spot
contaminated

If after having changed the sensor membrane
the calibration still takes almost 14 minutes or
cannot be completed within 14 minutes
contact qualified service personnel to clean
the sensor without membrane.

Clean the sensor as described in

section 3.1.7

“Cleaning / Inspecting without Membrane”.

Then calibrate the sensor.

4 Troubleshooting

SenTec Digital Monitoring System

57

Problem

Possible Cause(s)

Recommended action(s)

SenTec TC Sensor
defective

If the problem persists the SenTec TC Sensor
is defect. Replace it with a new one.

P0305

PCO2
sensitivity of
the sensor
low /
Message

‘Sensor
problem 12’

OR

PO2
sensitivity of
the PO2
sensor low /
Message

‘Sensor
problem 72’

Membrane related
(defective or dried
up electrolyte)

Change the membrane:

- if it is damaged or missing, has a loose fit,

or if there is trapped air or dry electrolyte
under the membrane

- if the ‘Sensitivity Test’ fails.

Note: If the ‘Sensitivity Test’ fails the
message ‘Sensor problem 12’ displays and

PCO2 subsequently will be flagged as invalid

Note: If the ‘Sensitivity Test’ fails the
message ‘Sensor problem 72’ displays and

PO2 subsequently will be flagged as invalid

PCO2 electrode
and/ or white PO2
sensing spot
contaminated

If after having changed the sensor membrane
the ‘Sensitivity Test’ still fails contact qualified
service personnel to clean the sensor without
membrane.

Clean/Inspect the sensor as described in

section 3.1.7 “Cleaning / Inspecting without
Membrane”

and perform the ‘Sensitivity Test’

as described in

section 3.1.8 “PCO2 / PO2

Sensitivity & Calibration Duration

”.

If problem persists contact SenTec authorized
service personnel.

SenTec TC Sensor
defective

If the problem persists the SenTec TC Sensor
is defect. Replace it with a new one.

Docking Station
Solenoid Valve
defective

Note: Only for SMB

7.00 or lower.

If problem persists the Docking Station
Solenoid Valve is defective. Replace it by
original replacement parts according to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0306

Status
Message

‘Temp. limiter
active’ /

Message

‘Sensor

problem 38-

42’

Temperature of the
SenTec TC Sensor
is increased, e.g.
because of
warming lamps or
electric blankets

Shield sensor from heat.

SenTec TC Sensor
defective

If the problem persists the SenTec TC Sensor
is defect. Replace it with a new one.

SDM defective

Refer to

section 4.2.4 “SDM specific

troubleshooting”

to further evaluate the

problem.

4 Troubleshooting

HB-005615-j

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Problem

Possible Cause(s)

Recommended action(s)

P0307

Sensor is
blocked in
Membrane
Changer tool

Membrane change
tool is blocked

Open the Membrane Change Tool as
described in

section 3.5 “Opening the

Membrane Changer”.

P0308

SenTec TC
Sensor
calibration
does not
start

Sensor temperature
is too low

Wait until the sensor temperature is less than

0.5 °C below the SET temperature.

If problem persists, test the same sensor
connected to another SDM using another
extension cable.

SenTec TC Sensor
defective

If the problem persists the SenTec TC Sensor
is defect. Replace it with a new one.

SDM defective

If problem (i.e. testing the sensor connected
to another SDM) does not persist, then the
problem is related to the SDM, refer to

section 4.2.4 “SDM specific troubleshooting”

,

to further evaluate the problem.

P0309

OxiVenT™

Sensor
connected to
SDM, but
PO2
measurement
flagged to be
invalid or not
available

PO2 option of the
SDM not activated
or – if activated ­PO2 not enabled in
the menu of the
SDM

Ensure that PO2 option of the SDM is
activated and PO2 is enabled in the menu of
the SDM. After doing so, verify that the off­centered white spot is illuminated in green
cyan color.

LED of the PO2­module defective

The sensor can still be used for monitoring of
the other parameters but PO2. Replace
OxiVenT™ Sensor if you wish to continue
monitoring PO2.

Note: In this case the SDM should display
the message ‘Sensor problem 70’ (see

Technical Manual for the SDM

).

Photodiode of the
PO2-module
defective

The sensor can still be used for monitoring of
the other parameters but PO2. Replace

OxiVenT™ Sensor if you wish to continue

monitoring PO2.
Note: In this case the SDM should display

the message ‘Sensor problem 71’ (see

Technical Manual for the SDM

).

4 Troubleshooting

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59

Problem

Possible Cause(s)

Recommended action(s)

PO2-module error
detected

General PO2-module error detected (e.g. off­centered white spot missing).

The sensor can still be used for monitoring of
the other parameters but PO2. Replace

OxiVenT™ Sensor if you wish to continue

monitoring PO2.
Note: In this case the SDM should display

the message ‘Sensor problem 73’ (see

Technical Manual for the SDM

).

4.2.4 SDM specific troubleshooting

Table 9 SDM specific troubleshooting

Problem

Possible Cause(s)

Recommended action(s)

P0400

SDM not
operational,
SDM LEDs
not
illuminated

SDM switched off

Switch on SDM.

SDM not connected
to mains and
battery depleted

Connect the SDM to the mains. Allow battery
to charge.

Mains power supply
defective

Choose another mains power supply for
connecting the SDM.

SDM defective

Switch the SDM off and on again.
If problem persists contact qualified service

personnel.

Main fuses
defective

Replace main fuses according to section 5.4
Replacement, main fuses.

SDM defective

Contact SenTec authorized service personnel.

AC/DC Power
Supply not
connected

Connect AC/DC Power Supply according to
the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

AC/DC Power
Supply defective

Replace AC/DC Power Supply according to
the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

4 Troubleshooting

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Problem

Possible Cause(s)

Recommended action(s)

SMBM
(Motherboard)
defective

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0401

Display is
dark, AC
Power /
Battery
indicator
(green /
yellow LED)
illuminated

ON / OFF
indicator
(green LED)
dark

SDM switched off

Switch on SDM.
If problem persists contact qualified service

personnel.

SDM defective

Contact SenTec authorized service personnel.

Power ON/OFF
Switch not
connected

Connect Power ON/OFF Switch according to
the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Power ON/OFF
Switch defective

Replace Power ON/OFF Switch according to
the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBC (Controller
Board) defective

Replace SMBC according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBM
(Motherboard)
defective

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0402

fully charged
Battery is
discharged
after less
than 4 h

Battery defective

Contact qualified service personnel.
SDM defective

Contact SenTec authorized service personnel.

Insufficient capacity
of the rechargeable
Lithium Battery

Replace Rechargeable Lithium Battery
according to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Rechargeable
Lithium Battery
defective

Replace Rechargeable Lithium Battery
according to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

4 Troubleshooting

SenTec Digital Monitoring System

61

Problem

Possible Cause(s)

Recommended action(s)

MPB
(Multiparameterboa
rd, SM1A) defective

Replace MPB according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBC (Controller
Board) defective

Replace SMBC (Controller Board) according to
the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Docking Station
Module defective

Replace Docking Station Module according to
the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBM
(Motherboard)
defective

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Display Module
defective

Replace Display Module according to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0403/P0504

Display is
dark, ON /
OFF indicator
is illuminated
OR
Display is not
readable
(dark)

SDM in Sleep Mode

Press any button.
If the problem persists switch the SDM off

and on again.
If problem persists contact qualified service

personnel.

Brightness not
adjusted correctly.

Switch the monitor off and on again. Then
readjust the brightness (‘UP/DOWN Buttons’).

SDM defective

Switch the SDM off and on again.
If problem persists contact qualified service

personnel.

SDM defective

Contact SenTec authorized service personnel.

Display Module not
connected

Connect Display Module according to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Display Module
defective

Replace Display Module according to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

4 Troubleshooting

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Problem

Possible Cause(s)

Recommended action(s)

SMBC (Controller
Board) defective

Replace SMBC according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBM
(Motherboard)
defective

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0405

POST screen
does not
disappear

POST failed

Write down the Error code, switch the SDM
off and on again.

If problem persists contact qualified service
personnel.

SDM defective

Contact SenTec authorized service personnel.

SMBC (Controller
Board) defective

Replace SMBC according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBM
(Motherboard)
defective

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0406

SDM does
not react if
any button is
pressed

Menu-Access
disabled

Refer to P0420

SDM firmware is
not responding
(firmware has
crashed)

Switch the monitor off and on again.
If problem persists contact qualified service

personnel.

SDM defective

Contact SenTec authorized service personnel.

Keyboard not
connected

Connect Keyboard according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Keyboard defective

Replace Keyboard according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

4 Troubleshooting

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63

Problem

Possible Cause(s)

Recommended action(s)

SMBC (Controller
Board) defective

Replace SMBC according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBM
(Motherboard)
defective

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0407

‘Watch
battery low’

displays

Internal watch /
clock battery is low

Must be replaced, contact qualified service
personnel.

Note: Refer to the sub-section ‘POST’ in the

Technical Manual for the SDM

and to Status

Messages ‘Watch battery low’ and ‘Set Date /
Time’.

SDM defective

Contact SenTec authorized service personnel.

Internal battery on
SMBC (Controller
Board) low

Replace internal battery on SMBC according
to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBC (Controller
Board) defective

Replace SMBC according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0408

Wrong /
unstable
barometric
pressure

Barometer chip
defective

Verify that the barometric pressure reading of
the SDM is stable during calibration and does
not deviate from a known calibrated reference
barometer by more than 3 mmHg (0.4 kPa).
Otherwise contact qualified service personnel.

Note: The ‘Barometer Icon’ only displays if

PCO2 is enabled and the SenTec TC Sensor is
connected to the SDM and inside the Docking
Station.

Note: Also refer to Status Messages ‘Atm. P.
unstable’ and ‘Barometer fault’.

SDM defective

Contact SenTec authorized service personnel.

MPB
(Multiparameter­board, SM1A)
defective

Replace MPB according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

4 Troubleshooting

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Problem

Possible Cause(s)

Recommended action(s)

P0409

Fan is noisy

Fan defective or
polluted

Remove mains connection and – if active –
wait until fan operation stops, then clean
ventilation slots.

Contact qualified service personnel if problem
persists.

SDM defective

Contact SenTec authorized service personnel.

Fan polluted

Clean case and Fan according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Fan defective

Replace Fan according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0410

Fan is
blocked

Fan defective or
polluted

The fan has to be able to rotate freely. Check
ventilation slots if something is blocking the
fan.

If problem persists contact qualified service
personnel.

SDM defective

Contact SenTec authorized service personnel.

Fan not connected

Connect Fan according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Fan polluted

Clean case and Fan according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Fan defective

Replace Fan according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBC (Controller
Board) defective

Replace SMBC according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

4 Troubleshooting

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65

Problem

Possible Cause(s)

Recommended action(s)

SMBM
(Motherboard)
defective

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0411

No sound

Auditory alarm
signals are PAUSED
or OFF

Reactivate auditory alarm signals (if
necessary)

Volume is on
minimum

Adjust the volume in the menu “Alarm
Settings”.

Speaker is defective

Verify that 3 beeps are audible during POST.
If problem persists contact qualified service
personnel.

SDM defective

Contact SenTec authorized service personnel.

Speaker not
connected

Connect Speaker according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Speaker defective

Replace Speaker according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBC (Controller
Board) defective

Replace SMBC according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBM
(Motherboard)
defective

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0412

AC Power Cord is
defective

Replace the AC Power Cord.

Power Entry
Module defective

Contact qualified service personnel.
Fuse Holder not

mounted correctly

Mount Fuse Holder correctly according to

section 5.4 “Replacement, main fuses”

.

SDM defective

Contact SenTec authorized service personnel.

4 Troubleshooting

HB-005615-j

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Problem

Possible Cause(s)

Recommended action(s)

It is not
possible to
connect the
AC power
cord in the
SDM AC
power
connector

AC Power
Connector defective

Replace AC Power Connector according to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0413

Disruptive
discharges
during the
high tension
test

SDM defective

Contact SenTec authorized service personnel.

SMBM
(Motherboard)
defective

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0414

Wrong or no
analog
output

SDM defective
or
wrong / defective

cable

Contact qualified service personnel.

SDM defective

Contact SenTec authorized service personnel.

SMBC (Controller
Board) defective

Replace SMBC according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBM
(Motherboard)
defective

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0415

No communi­cation over
RS-232

Wrong serial
communication
protocol

Make sure to select appropriate serial
protocol

SDM defective
or
wrong / defective

cable

Contact qualified service personnel.

SDM defective

Contact qualified service personnel.

SDM defective

Contact SenTec authorized service personnel.

SMBC (Controller
Board) defective

Replace SMBC according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

4 Troubleshooting

SenTec Digital Monitoring System

67

Problem

Possible Cause(s)

Recommended action(s)

SMBM
(Motherboard)
defective

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0416

No alarm on
speaker,
nurse call

Auditory alarm is
muted

Auditory alarm signals can be muted for 1
minute, 2 minutes or permanently with the
Alarm Mute Button.

Push the Alarm Mute Button.
Refer to P0411.

SDM defective

Contact qualified service personnel.

SDM defective

Contact SenTec authorized service personnel.

SMBC (Controller
Board) defective

Replace SMBC according to the

Repair Manual

for the SDMS

.

To be performed by SenTec authorized

service technicians only.

SMBM
(Motherboard)
defective

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0417

Safety test
does not
comply

SDM defective

Contact SenTec authorized service personnel.

Protective Earth
Resistance is more
than 0.2 Ω

Control the Protective Earth wiring between
the AC Power Connector, the Equipotential
Terminal and the Gas bottle.

To be performed by SenTec authorized

service technicians only.

Protective Earth
wiring defective

If problem persists, replace Protective Earth
according to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Leakage current
too high

Replace SMBM according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

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HB-005615-j

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Problem

Possible Cause(s)

Recommended action(s)

P0418

Gas Level
Indicator
shows wrong
indication

Gas level indicator
shows wrong
results

Repeat the test with the same sensor
connected to the same SDM using the
Docking Station of another SDM (Both SDMs
need to be switched on).
Make sure the sensor is in the Docking
Station and the door is closed correctly, wait
5 seconds.
Contact qualified service personnel if the
problem persists.

SDM defective

Contact SenTec authorized service personnel.

DS Module
defective

Replace DS Module according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0419

Despite a
SenTec TC
Sensor is
connected to
the SDM the
message

‘Connect
sensor’

displays

Refer to P0300

P0420

SDM Menu
cannot be
accessed

Menu cannot be
activated when
pressing menu
button, a long low
tone is audible
instead

Blocked menu access: Menu access has been
deactivated by the Responsible Organization.

4 Troubleshooting

SenTec Digital Monitoring System

69

4.2.5 Docking Station specific troubleshooting

Table 10 Docking Station specific troubleshooting

Problem

Possible Cause(s)

Recommended action(s)

P0500

Docking
Station door
does not
close
properly

Sensor cable
jammed in the door

Adjust cable and close the Docking Station
door properly.

Sensor not inserted
properly in the
Docking Station
door.

Insert the sensor properly and close the door.
Mechanical defect
of the Docking
Station door

Contact qualified service personnel.

Mechanical defect
of the Docking
Station door

Replace Docking Station door according to

section 5.5 “Replacement, Docking Station
Door”

.

Gasket not placed
correctly

Place gasket correctly in the chamber in the
Docking Station according to

section 5.6

“Replacement, Docking Station Gasket”

.

Docking Station
door mechanically
defective

Replace Support for Docking Station Door
according to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0501

Message

‘Docking
Station Fault’

is displayed

Contaminations
(e.g. gel residues)
disturb the gas flow

Clean Docking Station and SenTec TC Sensor
and then insert the sensor into the Docking
Station.

If problem persists contact qualified service
personnel.

Note: Refer to the

Instruction Manual for the

SDMS.

Docking Station
defective

Contact SenTec authorized service personnel.

Docking Station
Module defective

Replace Docking Station Module according to
the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0502

Message ‘Gas

leak in DS’ is
displayed or
a gas leak is

Sensor not properly
positioned in
Docking Station
during last
calibration.

Verify that the sensor is clean and is properly
placed into the holder at the inside of the
Docking Station door and that the door
properly closes (refer to the

Instruction

Manual for the SDMS

).

4 Troubleshooting

HB-005615-j

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Problem

Possible Cause(s)

Recommended action(s)

suspected
(see Status
Code DP02 in
memory
dump)

Gasket of Docking
Station
contaminated

Clean the Docking Station gasket with a
cotton swab with 70% isopropanol. Remove
any residual threads and fibers and allow to
dry.

Note: Always clean the sensor before
inserting it into the Docking Station.

Gasket of Docking
Station defective or
missing

Carefully inspect the gasket and verify that it
is present and well embedded in its notch.

If damaged contact qualified service
personnel.

Docking Station
door and / or
closing mechanism
defective

Carefully inspect the door and the closing
mechanism for mechanical or functional
damage. The closing mechanism must
properly lock in place.

If damaged contact qualified service
personnel.

Docking Station
door mechanically
defective

Replace Docking Station door according to

section 5.5 “Replacement, Docking Station
Door”

.

Gasket defective /
missing

Place gasket correctly in the chamber in the
Docking Station according to

section 5.6

“Replacement, Docking Station Gasket”

.

SDM defective

Contact SenTec authorized service personnel.

Calibration Module
defective

Replace Calibration Module according to the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Docking Station
Module defective

Replace Docking Station Module according to
the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

Note: Also refer to messages ‘Gas leak in DS’, ‘Leak test in

progress’ described in the

Technical Manual for the SDM

.

P0503

Service Gas
bottle cannot
be installed
properly

Plastic lid of the
new Service Gas
bottle not removed

Remove the plastic lid and install the Service
Gas bottle.

Foreign body in the
slot for the Service
Gas bottle

Switch off the SDM, disconnect it from the
mains supply and remove the foreign body
from the slot on the rear panel of the SDM.

4 Troubleshooting

SenTec Digital Monitoring System

71

Problem

Possible Cause(s)

Recommended action(s)

Thread of the
Service Gas bottle
is damaged

Use a new Service Gas bottle and install it as
described in

Instruction Manual for the SDMS

.

SDM is defective

Contact qualified service personnel.

SDM defective

Contact SenTec authorized service personnel.

Docking Station
Module defective

Replace Docking Station Module according to
the

Repair Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

P0504

Consumption
of the

Service

Gas

is higher
than usual
(message

‘Gas leak in
DS’ does not

display)

Low pressure side
residual gas flow
too high

Verify whether DP01 status code is flagged.
Contact qualified service personnel.

High pressure part
of the Docking
Station Module is
leaky

Contact qualified service personnel.

Unstable sensor
requiring too many
calibrations

Remembrane sensor and observe gas
consumption.

If problem persists, contact qualified service
personnel.

SDM defective

Contact SenTec authorized service personnel.

Gasket in the
Docking Station
Module thread for
the Service Gas is
polluted or
damaged

Clean gasket in the Docking Station Module
thread according to the

Repair Manual for the

SDMS

.

To be performed by SenTec authorized

service technicians only.

Docking Station
Solenoid Valve
defective

If problem persists the Docking Station
Solenoid Valve is defect. Replace it by original
replacement parts according to the

Repair

Manual for the SDMS

.

To be performed by SenTec authorized

service technicians only.

4 Troubleshooting

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72

Problem

Possible Cause(s)

Recommended action(s)

P0505

Sensor
calibration
does not
start, Sensor
LED is
illuminated

Refer to P0308

P0506

Gas Level
Indicator
shows wrong
indication

Refer to P0418

5 Repairs of the SDM

SenTec Digital Monitoring System

73

5 Repairs of the SDM

Repairs described in this chapter do not require opening the SDM`s cover and shall be
carried out by qualified service personnel only.

Repairs that require opening the cover of the SDM are to be performed by SenTec
authorized service technicians only (i.e. trained by SenTec AG or accredited partners)
and are described in detail within the

Repair Manual

.

Prior to maintenance, service or repairs all components of the SDMS must be cleaned
and disinfected. If equipment is send to service personnel, a local SenTec
representative or to SenTec AG a completed

“Certificate for Disinfection” (see section

8.7

) must be attached.

If you need to return devices for service or repair follow the shipment instructions in

section 8.6 “Instructions for Shipment”.

Send defective parts together with the completed

"Repair or Investigation Request

Form"

to your local SenTec representative. The

"Repair or Investigation Request Form"

may be copied from

section 8.3 “Repair or Investigation Request Form”.

To ensure traceability – a regulatory requirement – SenTec AG needs to know the
serial and LOT numbers as well as software versions of all components of the SDMS.

This means, if you replace parts of the SDM of if you perform a software
update you must report the serial number of the respective SDM and the
serial and LOT numbers of the replaced parts using the

“Repair Reporting

Form”

see

section 8.4

to your local distributor.

For spare parts and test tools refer to in

section 8.2 “Testing Accessories and Spare

Parts”.

Tools

 Screwdriver large slotted 3 mm
 A pair of pointed tweezers
 A pair of normal tweezers

WARNING: Maintenance and repairs requiring removal of the
case or covers may only be carried out by SenTec authorized
service personnel trained by SenTec AG or accredited partners.

WARNING: Use only accessories and spare parts supplied or
recommended by SenTec AG. Do not perform other service and
repair activities than specified and described by SenTec AG.
Failure to comply may result in physical injury, inaccurate
measurements, and/or damage to the device.

5 Repairs of the SDM

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74

WARNING: Before replacing fuses of the SDM, disconnect the
device from the AC power.

CAUTION: Follow ESD (Electrostatic discharge) precautions
when working with the SDM, especially when disassembling and
reassembling the SDM and when handling any of the
components. Use an ESD protective wrist-strap and table-mat
connected to Earth while working with the electronics.

5.1 Prior to Repair

1. Prior to repair all components of the SDMS must be cleaned and disinfected as

described in the corresponding section of the

Technical Manual for the SDM

.

Check that the sender completed and enclosed the

"Disinfection Certificate" (see

section 8.7

).

2. If necessary, clean and disinfect the device as described in the corresponding

section of the

Technical Manual for the SDM

.

3. Set the ON/OFF Switch of the SDM to OFF.

4. Disconnect all connections on the rear panel of the device.

5.2 Replacement, Tip-up Foot

1. Follow the procedure described in section 5.1 "Prior to Repair".

2. Fold out the tip-up foot. Expand it on one side to release the first pin from the

positioning hole. Then remove the whole Tip-up foot.

3. Fix the new tip-up foot (see

section 8.2 “Testing Accessories and Spare Parts”

)
by inserting one pin into the positioning hole on one side. Enlarge the tip-up foot
and engage the second pin on the other side.

Pin

Figure 12 Replacement, Tip-up Foot

5 Repairs of the SDM

SenTec Digital Monitoring System

75

5.3 Replacement, Silicon Foot

1. Follow the procedure described in

section 5.1 "Prior to Repair".

2. Clean the groove for the silicon foot with a cotton swap soaked with 70%

isopropanol.

3. Put one drop of silicon glue (see

section 8.2 “Testing Accessories and Spare

Parts”

) in the groove.

4. Insert the new silicon foot into the groove by pressing firmly.

5. Allow the glue to dry.

Figure 13 Replacement, Silicon Foot

5.4 Replacement, main fuses

1. Follow the procedure described in

section 5.1 "Prior to Repair"

.

2. Remove the fuse holder from the AC Power Connector by compressing the two tabs

on both sides of the lid and pulling out the fuse holder according to

Figure 14

Replacement, Main Fuses

.

3. Replace the defective fuses with time delay, high breaking capacity fuses, by fuses

with rated current as specified on the SDM rear panel (see section 8.2 “Testing
Accessories and Spare Parts”)

4. Reinsert the holder into the AC Power Connector.

Fuse drawer

Figure 14 Replacement, Main Fuses

5 Repairs of the SDM

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76

5.5 Replacement, Docking Station Door

1. Follow the procedure described in

section 5.1 "Prior to Repair"

.

2. Open the Docking Station Door (to an angle of approximately 120° (

see Figure 15

Docking Station Door Insertion

).

3. Lift the mounting link for the hinge and remove the Docking Station Door by

pulling it out and pressing it down at the same time.

4. Insert the new Docking Station Door (parallel to the case) with an aperture angle

of the door of 45° (see

section 8.2 “Testing Accessories and Spare Parts”

). The
door must not be closed further, as this could damage the pressure spring. First
press on the bottom, then on the top of the door to insert the hinge into the
mounting link.

5. Switch on the monitor.

6. Put the sensor into the Docking Station to calibration the sensor. After calibration

wait 6 minutes to verify that the message `Gas leak in DS´ does not display.

approx. 120º

mounting link for the hinge
pressure spring

Figure 10 Docking Station Door removal

mounting link for the hinge

Figure 15 Docking Station Door Insertion

5 Repairs of the SDM

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77

5.6 Replacement, Docking Station Gasket

1. Follow the procedure described in

section 5.1 "Prior to Repair".

2. Open the Docking Station door.

3. Remove the defective gasket using tweezers. Take care not to damage the lining

groove.

4. Clean the lining groove using a cotton swap soaked with 70% isopropanol, allow

to dry.

Note: Do not use grease or talcum powder for pre-treatment of gasket before inserting
it. Clean especial carefully the lining groove, as described above, if grease or talcum
powder has been used before.

5. Insert a new (asymmetric) gasket (see

Figure 16 Replacement, Docking

Station Gasket and Figure 17 Positioning of the Docking Station Gasket

) by
pressing it with a cotton swab soaked with 70% isopropanol into the lining
groove. Make sure that no cotton fibers remain on the gasket as this might cause
leak problems.

6. Allow to dry.

7. Switch on the monitor.

8. Put the sensor into the Docking Station to calibration the sensor. After calibration

wait 6 minutes to verify that the message “Gas leak in DS” does not display.

gasket

Figure 16 Replacement, Docking Station Gasket

5 Repairs of the SDM

HB-005615-j

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Figure 17 Positioning of the Docking Station Gasket

6 Software Updates

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79

6 Software Updates

The field-upgradable software of the SDM consists of two items:

1. SMBC – Controller Board software (User Interface, Memory and Interface

management)

2. MPB – Multiparameterboard software (Signal Analysis Algorithm)

The SMBC and MPB software can be updated by trained and authorized personnel by
flashing a new version in the flash memory of the existing boards (note: detailed
instructions are included in separate documents).

WARNING: Software updates of the SDM must be carried out
by trained and authorized personnel. Software updates must be
reported to SenTec by using the Repair Reporting Form,

see

section 8 “Appendix”

, to ensure traceability.

7 Disposal

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80

7 Disposal

The SDMS is constructed with environment-friendly material. It contains electronic
printed circuit boards, a display, cables and lithium batteries.

Do not incinerate equipment or gas bottles.

WEEE Disposal: European consumers are obliged by law to dispose Waste Electrical
and Electronic Equipment (WEEE) according to the WEEE Directive:

1. All electrical and electronic waste, must be stored, collected, treated, recycled

and disposed of separately from other waste

2. Consumers are obliged by law to return electrical and electronic devices at the

end of their service lives to the public collection points set up for this purpose
or point of sale. Details to this are defined by the national law of the respective
country.

Note: By recycling materials or other forms of utilizing old devices, you are making an
important contribution to protecting our environment.

7.1 SenTec Digital Monitor

Return the SDM to your local SenTec representative or dispose it according to local
regulations.

7.2 Cables

Dispose the cables according to local regulations. The copper contained can be
recycled.

7.3 SenTec TC Sensors

Return the SenTec TC Sensors to your local distributor.

7.4 Service Gas Bottle

Dispose the gas bottles according to local regulations. Make sure that only empty gas
bottles are disposed.

WARNING: Pressurized container. Protect from sunlight and do
not expose to temperatures exceeding 50°C (122°F). Do not
pierce or burn, even after use. Do not spray on a naked flame
or any incandescent material.

7.5 Consumables

All material used is considered "non critical". The consumables may be disposed with
the regular garbage collection.

8 Appendix

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81

8 Appendix

8.1 Protocol for Safety & Functionality Test

This protocol is intended to be used by qualified service personnel.

Please refer to the document:

HB-005638

8.2 Testing Accessories and Spare Parts

WARNING: Use only testing accessories and spare parts

supplied or recommended by SenTec AG. Use of other than
supplied or recommended parts may result in physical injury,
inaccurate measurement and/or damage to the device.

Contact SenTec authorized service personnel.

8.3 Repair or Investigation Request Form

Please refer to the document:

HB-005643

8.4 Repair Reporting Form

Please refer to the document:

HB-005729

8.5 Customer Feedback Form

Please refer to the document:

HB-006872

8.6 Instructions for Shipment

Please refer to the document:

HB-005891

8.7 Certificate for Disinfection

Please refer to the document:

HB-005637

8 Appendix

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82

8.8 SDMS Maintenance Checklist

This checklist is intended to be used by the operator.

Please refer to the document:

HB-007601

8.9 Interfaces - Pin Assignement

WARNING: The mains power supply of the SenTec Digital

Monitor (SDM) is separated by two Means of Patient Protection
(MOPPs) between the sensor port (for the applied part, the
sensor) and the interface connectors. The three interface
connectors - serial data port, Multipurpose I/O port (analog
outputs, nurse call), LAN port - of the SDM are not separated
from each other. If at a time accessory equipment is connected
to only one of the three interface connectors no additional safety
measures are necessary to comply with the requirements of IEC
60601-1. If however accessory equipment is simultaneously

connected to two or three of the SDM’s interface connectors

additional safety measures may be required to be compliant with
the requirements of IEC 60601-1. In case of doubt consult
qualified technicians.

8 Appendix

SenTec Digital Monitoring System

83

8.9.1 Sensor Connection Port

Figure 18 Sensor Connection Port

Table 11 Pin Assignment, Sensor Connection Port

Pin(s)

Signal

1 - 3

(reserved)

4

Signal Ground

5

Received Data (RX, from Sensor)

6

Transmitted Data (TX, to Sensor)

7 - 9

(reserved)

10

5 V, for sensor supply only

11

Supply Ground

12

3.3 V, for sensor supply only

13 - 14

(reserved)

8 Appendix

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8.9.2 The Serial Data Port (RS-232)

1 5

6 9

Figure 19 Serial Data Port (RS-232)

Table 12 Pin Assignment, Serial Data Port (RS-232)

Pin(s)

Signal

1

(reserved)

2

Transmitted Data (TX, from SDM)

3

Received Data (RX, to SDM)

4

(reserved)

5

Signal Ground

6 – 9

(reserved)

8.9.3 Multipurpose I/O Port

Figure 20 Multipurpose I/O Port

8 Appendix

SenTec Digital Monitoring System

85

Table 13 Pin Assignment, Multipurpose I/O Port

Pin(s)

Signal

Signal Range

Voltage

Analog Output

1

Pleth Signal

Voltage: 0 – 1.05 V
Parameter Range: min – max (not

selectable)

2

Pleth Ground

3

PR Signal

Voltage: 0 – 1.05 V
Parameter Range: 30–80, 30–125,

50–120, 100–250, 30–250 (bpm)

4

PR Ground

5

SpO2 Signal

Voltage: 0 – 1.05 V
Parameter Range: 0-100, 50-100,

70-100, 85-100 (%)

6

SpO2 Ground

7

PCO2 Signal

Voltage: 0 – 1.05 V
Parameter Range: 10-50, 25-55,

25-75, 35-100, 60-140, 75-200,
120-200, 0-75, 0-100, 0-200
mmHg / 1.5-7, 3.5-7.5, 3.5-10.0,

4.5-15.0, 8-18.0, 10.0-27.0, 16.0-

27.0, 0-10.0, 0-15.0, 0-27.0 kPA

8

PCO2 Ground

9 – 13

(reserved)

14

Ground

15 - 16

(reserved)

17

Ground

18 - 19

(reserved)

20 - 21

Ground

22

3.3 V, max. 15 mA

23

Ground

Nurse Call

24

Common lead for Nurse Call
relays 1 + 2

-

-

(24 + 25)

Nurse Call relay 1

open, close

closes upon SDM

audible alarm

(24 + 26)

Nurse Call relay 2

close, open

opens upon SDM

audible alarm

Note:

Output of PO2, PI and HP data via the Analog Output is currently not
supported.

8 Appendix

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86

8.9.4 Network Port (LAN)

The LAN port of the SDM is used to communicate with external computer based data
collection systems. The LAN port is located on the rear panel of the SDM. The LAN port
is a standard 10Base-T Ethernet connector. Use Category 3 (Cat3) or preferably
Category 5 (Cat5) Ethernet cables for connection of the monitor to a network hub or
switch. You may also use a cross-over Ethernet cable for direct connection of the
monitor to a computer without a hub or switch.

Note: While trend data are downloaded via the LAN interface the serial interface of

the SDM is inactivated. Once data download via the LAN interface is completed
the serial interface is reactivated.

8.10 Technical Specifications

See the corresponding section of the

Technical Manual for the SDM

.

8.11 Contact

Phone: [phone]

Monday to Friday, 08:30 - 12.00 und 14.00 - 17:00 (GMT +01:00)

e-Mail: [e-mail]

8 Appendix

SenTec Digital Monitoring System

87

HB-005615-j

Date of release: 02/2019