Schiller PHYSIOGARD Touch 7 User manual

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DEFIGARD
TOUCH 7
1):4*0GARD
TOUCH 7

User guide
Art. no.: 0-48-0227 Rev.: g * 0-48-0227 *

Manufacturer
SCHILLER MEDICAL Phone [phone]
4, rue Louis Pasteur Fax [phone]
F- 67160 Wissembourg E-mail: [email protected]
Web: www.schiller-medical.fr
Sales and Service Information
The SCHILLER sales and service centre network is world-wide. For the address of your
local distributor, contact your nearest SCHILLER subsidiary.
In case of difficulty, you can find a complete list of all distributors and subsidiaries on our
Internet site:
http://www.schiller.ch
Sales information can also be obtained from:
[e-mail]
Art. no./revision: Date Note
0-48-0227 a 16.12.2014 Version a for testing
0-48-0227 b 3.06.2015 Updated version for validation
0-48-0227 c 1.09.2015 Updated version with minor changes
0-48-0227 d 7.04.2016 Add new feature CO2 and
PHYSIOGARD Touch 7 and other changes.
0-48-0227 e 25.01.2017 Adding correction according to Mantis. Add
IBP and Pacemaker.
0-48-0227 f 3.11.2017 Update to Software revision 6
0-48-0227 g 8.02.2018 Adding correction according to Mantis .
The DEFIGARD Touch7 bears the CE-0459 mark (Notified Body LNE/G-MED), indicating its compli-
ance with the essential requirements of the Annex I of the Medical Device Directive 93/42/EE re-
garding safety, functionality and labelling. The requirements apply to patients, users and third per-
sons who come into contact with this device within the scope of its intended use. First declaration
26.04.2015
The PHYSIOGARD Touch 7 bears the CE-0459 mark (Notified Body LNE/G-MED), indicating its com-
pliance with the essential requirements of the Annex I of the Medical Device Directive 93/42/EE re-
garding safety, functionality and labelling. The requirements apply to patients, users and third per-
sons who come into contact with this device within the scope of its intended use. First declaration
7.04.2016
Article no.: 0-48-0227 Rev.: g
Issue date: 8.02.2018
Translation: original
SW ≥6

Page 3
User guide
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
Table of Contents
1 Safety notes .............................................. 9
1.1 User profiles.......................................................................... 9
1.2 Intended Use ......................................................................... 9
1.3 Contraindication for use .................................................... 10
1.4 Responsibility of the User ................................................ 11
1.5 Organisational Measures................................................... 11
1.6 Safety-Conscious Operation ............................................. 12
1.7 Operation with other Devices............................................ 13
1.8 Maintenance........................................................................ 13
1.9 Hygiene................................................................................ 14
1.10 Networks and Internet........................................................ 14
1.11 Additional Terms ................................................................ 15
1.11.1 Implied Authorisation........................................................................ 15
1.11.2 Terms of Warranty ........................................................................... 15
1.12 Display Symbols/Indicators............................................... 16
1.12.1 Symbols Used in this User Guide .................................................... 16
1.12.2 Symbols used on the device ............................................................ 17
1.12.3 Symbols Used on the Batteries........................................................ 18
1.12.4 Symbols Used on the Electrode Package........................................ 19
2 Components and Operation .................. 20
2.1 Design.................................................................................. 20
2.1.1 Standard unit and options ................................................................ 21
2.1.2 Additional accessories ..................................................................... 21
2.2 Operating Elements............................................................ 22
2.2.1 Front panel DEFIGARD®Touch 7 ................................................... 22
2.2.2 Front panel PHYSIOGARD®Touch 7.............................................. 23
2.2.3 Back Panel....................................................................................... 24
2.2.4 LEDs ................................................................................................ 24
2.2.5 Display ............................................................................................. 25
3 Initial Operation ...................................... 26
3.1 External DC supply and Battery Operation...................... 26
3.1.1 External DC Supply Operation ......................................................... 26
3.1.2 Battery Operation............................................................................. 27
3.1.3 Operation with external constant voltage source ............................. 28
3.1.4 Operation ambulance charging bracket ........................................... 29
3.1.5 Operation of the desktop charging bracket ...................................... 29
3.1.6 Operation and fixing during intervention .......................................... 30
3.2 Switching off and disconnecting from the external DC supply
31
3.2.1 Lock Touch screen........................................................................... 31
3.2.2 Internal safety discharge.................................................................. 31
3.2.3 Interruption of external power supply ............................................... 31
3.2.4 Ensuring Operational Readiness ..................................................... 32
3.3 Operation............................................................................. 33
3.4 Printing ................................................................................ 34
3.4.1 Pairing Bluetooth devices................................................................. 34
3.4.2 Brother Printer Overview.................................................................. 34

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Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
3.5 Connection to a ePCR system........................................... 35
3.5.1 Pairing Bluetooth devices ................................................................ 35
4 Monitoring ...............................................36
4.1 Soft keys, Waveforms and Measurement Fields ............. 36
4.1.1 View selection .................................................................................. 37
4.2 Alarm System...................................................................... 38
4.2.1 Alarm priority.................................................................................... 38
4.2.2 Operator’s position........................................................................... 38
4.2.3 Alarm list .......................................................................................... 38
4.2.4 Physiological alarms ........................................................................ 39
4.2.5 Technical alarms.............................................................................. 39
4.3 Operator-Defined Alarm Thresholds................................. 40
4.3.1 Table of wide/narrow threshold setting ............................................ 41
4.4 ECG and heart rate monitoring ......................................... 43
4.4.1 Quick Diagnosis of the ECG Using Defibrillation Electrodes ........... 43
4.4.2 Connecting a 4- or 10-wire ECG patient cable ................................ 43
4.4.3 Connecting a 4-wire ECG patient cable........................................... 44
4.4.4 Connecting a 10-wire ECG patient cable......................................... 44
4.4.5 Starting ECG monitoring .................................................................. 45
4.4.6 Monitoring a pacemaker patient....................................................... 46
4.4.7 Curve list .......................................................................................... 47
4.4.8 HR Module (ECG)............................................................................ 47
4.4.9 ECG messages................................................................................ 47
4.4.10 Print and pdf formats........................................................................ 48
4.5 Diagnostic ECG (R-ECG).................................................... 49
4.6 SpO2-, SpCO, SpMet monitoring (Option) ........................ 50
4.6.1 Inaccurate or incorrect measurement result .................................... 51
4.6.2 Starting SpO2monitoring and test................................................... 52
4.6.3 SpO2Module ................................................................................... 52
4.6.4 SpO2error and information messages .............................................. 53
4.7 NIBP monitoring ................................................................. 55
4.7.1 Starting NIBP monitoring ................................................................. 57
4.7.2 NIBP Menu....................................................................................... 58
4.7.3 NIBP Information and Error Messages ............................................ 58
4.8 IBP Monitoring .................................................................... 59
4.8.1 Preparing an IBP measurement....................................................... 59
4.8.2 Start IPB measurements.................................................................. 60
4.8.3 IBP menu settings............................................................................ 60
4.8.4 IBP zeroing ...................................................................................... 61
4.8.5 IBP alarms/messages ...................................................................... 61
4.9 Temperature monitoring .................................................... 62
4.9.1 Start temperature monitoring ........................................................... 62
4.9.2 Temperature menu settings ............................................................. 62
4.9.3 Temperature alarms......................................................................... 62
4.10 CO2 mainstream ................................................................. 63
4.10.1 IRMA mainstream gas analyser....................................................... 63
4.10.2 Preparing the IRMA sensor.............................................................. 64
4.10.3 Initial operation of the IRMA sensor................................................. 65
4.10.4 Placement of IRMA sensor .............................................................. 65
4.10.5 Zeroing of the IRMA CO2sensor..................................................... 66
4.10.6 Sensor LED indications.................................................................... 67
4.10.7 Settings etCO2menu....................................................................... 67
4.10.8 Curve list .......................................................................................... 67
4.10.9 CO2 error messages........................................................................ 68

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User guide
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
4.11 CO2 Sidestream .................................................................. 69
4.11.1 ISA gas analyser (sidestream measurement) .................................. 69
4.11.2 Initial operation of the ISA gas analyser........................................... 71
4.11.3 Sensor LED indications.................................................................... 71
4.11.4 Respiration rate alarms .................................................................... 72
4.11.5 Settings etCO2menu....................................................................... 73
4.11.6 Curve list .......................................................................................... 73
4.11.7 Zero adjustment of the CO2sidestream sensor .............................. 73
4.12 Registering events ............................................................. 74
4.13 View Trend, R-ECG and Screenshots............................... 75
4.13.1 View Trends ..................................................................................... 75
4.13.2 View resting ECG............................................................................. 75
4.13.3 View /Print Screenshots ................................................................... 76
4.14 Transmission ...................................................................... 77
4.14.1 Selecting communication media Wifi or GPRS ................................ 77
4.14.2 Transmission procedure................................................................... 77
5 Defibrillation ........................................... 78
5.1 Application guidelines and safety notes.......................... 78
5.1.1 Additional safety information for AED Mode .................................... 79
5.1.2 Defibrillating children/neonates........................................................ 80
5.2 General function ................................................................. 81
5.2.1 Activating the manual defibrillation mode......................................... 82
5.2.2 Activating the automated (AED) defibrillation mode......................... 83
5.2.3 Manual defibrillation procedure ........................................................ 84
5.3 Manual Defibrillation Using Pads...................................... 85
5.3.1 Applying the adult and paediatric electrodes ................................... 85
5.3.2 Applying the electrodes.................................................................... 86
5.3.3 Checking the electrodes................................................................... 87
5.3.4 Manual Defibrillation Using Pads Procedure.................................... 88
5.4 Synchronised defibrillation ............................................... 89
5.4.1 Warning erroneous triggering........................................................... 89
5.4.2 Setup switching from synchronized to unsynchronized mode ......... 89
5.4.3 Function of the Synchronized Defibrillation Procedure .................... 90
5.4.4 Synchronised defibrillation procedure .............................................. 91
5.5 Semi-automated defibrillation ........................................... 92
5.5.1 Semi-automated defibrillation (AED) procedure............................... 92
5.5.2 Voice messages in AED Mode......................................................... 93
5.5.3 Defibrillation procedure .................................................................... 94
5.6 CPR Guide........................................................................... 96
5.6.1 SCHILLER LifePoint......................................................................... 96
5.6.2 FreeCPR .......................................................................................... 97
5.6.3 Metronome settings.......................................................................... 97
5.7 Defibrillator Technical Messages...................................... 98

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Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
6 Pacemaker ...............................................99
6.1 Pacemaker Function........................................................... 99
6.1.1 Fixed-rate mode (Fix)....................................................................... 99
6.1.2 Demand mode ................................................................................. 99
6.2 Safety Notes ...................................................................... 100
6.3 Guidelines for the Application of External Pacemakers 100
6.3.1 Attaching the pacer pads ............................................................... 101
6.3.2 Checking the electrodes ................................................................ 101
6.4 Start-up of the Pacemaker ............................................... 102
6.4.1 Pacemaker display......................................................................... 103
6.4.2 Selecting pacemaker mode ........................................................... 103
6.4.3 Pacemaker settings operational mode fix ...................................... 104
6.4.4 Demand Mode ............................................................................... 105
6.4.5 Switching from pacemaker to defibrillation .................................... 105
7 Finishing the Therapy ..........................106
8 Intervention summary ..........................107
8.1 Post-intervention .............................................................. 108
8.1.1 Reviewing intervention file on the device....................................... 108
8.1.2 Transmitting the intervention file .................................................... 108
8.1.3 Autotest.......................................................................................... 108
9 Main Menu .............................................109
9.1 General setup.................................................................... 109
9.1.1 Device Settings Menu ................................................................. 110
10 Maintenance ..........................................112
10.1 Maintenance interval ........................................................ 112
10.1.1 Maintenance Interval Table............................................................ 112
10.1.2 Service/Shelf life ............................................................................ 113
10.2 Functional test .................................................................. 114
10.2.1 Visual inspection of the device and accessories............................ 114
10.2.2 Battery check ................................................................................. 114
10.2.3 Defibrillator key test ....................................................................... 114
10.2.4 Auto Test ....................................................................................... 115
10.2.5 Functional test - measured values................................................. 115
10.2.6 Alarm tests ..................................................................................... 115
10.3 Update Software .............................................................. 117
10.3.1 Update via USB ............................................................................. 117
10.3.2 Update via Server .......................................................................... 117
10.4 Maintenance interval of the batteries ............................. 118
10.4.1 Replacing the batteries .................................................................. 118
10.4.2 Battery disposal ............................................................................. 118
10.5 Cleaning............................................................................. 119
10.5.1 Detergents ..................................................................................... 119
10.6 Disinfection ....................................................................... 120
10.6.1 Disinfectant .................................................................................... 120
10.6.2 Cleaning and disinfecting the device, cable and sensors .............. 121
10.7 Disposal at the end of the device's useful life ............... 121
10.8 Inspection and Checklist Tables ..................................... 122

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User guide
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
10.8.1 Monthly........................................................................................... 122
10.8.2 Every 12 months ............................................................................ 123
10.8.3 Lifed-item replacement every 5 - 10 years..................................... 123
10.9 Error Detection ................................................................. 124
10.9.1 General errors ................................................................................ 124
10.9.2 Technical Information and Error Messages ................................... 125
10.9.3 Measures to prevent electromagnetic interferences ...................... 126
11 SCHILLER Charging Unit CS-1 ........... 127
11.1 Battery Charging Options................................................ 127
11.2 Inserting a battery ............................................................ 127
11.3 Control Panel .................................................................... 128
11.4 Battery Calibration ........................................................... 129
11.5 Input and Output Supplies............................................... 130
12 Technical Data ...................................... 131
12.1 System data ...................................................................... 131
12.2 Defibrillation Waveform ................................................... 134
12.2.1 Shock Advisory System ................................................................. 137
12.3 Pacemaker......................................................................... 138
12.4 Technical data - monitoring............................................. 139
12.4.1 ECG ............................................................................................... 139
12.4.2 Features of pacemaker pulse rejection .......................................... 140
12.4.3 NIBP - non-invasive blood pressure............................................... 141
12.4.4 IBP - invasive blood pressure ........................................................ 141
12.4.5 Temperature................................................................................... 141
12.4.6 SpO2- pulsoximetry....................................................................... 142
12.4.7 etCO2- Capnography .................................................................... 144
12.5 Telecommunication GSM (option) .................................. 146
12.6 Device Configuration ....................................................... 147
12.6.1 General configuration..................................................................... 147
12.6.2 ECG ............................................................................................... 148
12.6.3 Defibrillator..................................................................................... 149
12.6.4 Display ........................................................................................... 149
12.6.5 AED................................................................................................ 150
12.6.6 ECG ............................................................................................... 150
12.6.7 IBP ................................................................................................. 150
12.6.8 NIBP............................................................................................... 151
12.6.9 SpO2.............................................................................................. 151
12.6.10 Temp .............................................................................................. 151
12.6.11 EtCO2 ............................................................................................ 151
12.6.12 Time and date ................................................................................ 152
12.6.13 Event .............................................................................................. 152
12.6.14 SpO2 .............................................................................................. 152
12.6.15 Email configuration......................................................................... 152
12.6.16 Email adresses............................................................................... 153
12.6.17 Transmission.................................................................................. 153
12.6.18 Ethernet.......................................................................................... 153
12.6.19 WIFI................................................................................................ 154
12.6.20 GSM ............................................................................................... 154
12.6.21 SEMA ............................................................................................. 154
12.6.22 SUS (Schiller Update server) ......................................................... 155
12.7 Electromagnetic interferences ........................................ 156
12.7.1 Electromagnetic emissions ............................................................ 156

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Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
12.7.2 Electromagnetic immunity.............................................................. 156
12.7.3 Recommended minimum distances............................................... 158
13 Appendix ...............................................159
13.1 Accessories and disposables ......................................... 159
13.2 Accessories DEFIGARD/PHYSIOGARD Touch 7........... 159
13.3 Literature ........................................................................... 161
13.4 Glossary ............................................................................ 161
14 Index ......................................................163

Page 9
Safety notes 1
User guide User profiles 1.1
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
1 Safety notes
1.1 User profiles
Physician The DEFIGARD®Touch 7 must only be used by qualified medical or paramedic staff,
if the manual defibrillation mode is activated.
The PHYSIOGARD®Touch 7 must only be used by qualified medical or paramedic
staff.
Other persons The DEFIGARD®Touch 7 can be used by other persons (AED mode only if trained
in early defibrillation).
Training An initial training of at least 30 minutes is necessary and sufficient to use the device.
1.2 Intended Use
The PHYSIOGARD®Touch 7 is a monitor.
The DEFIGARD®Touch 7 is an emergency monitor / defibrillator.
Defibrillator
The DEFIGARD®Touch 7 defibrillation function is used for the treatment of
ventricular fibrillation (VF) and ventricular tachycardia (VT).
Transcutaneous Pacemaker
The pacemaker pulse is delivered using the same electrode pads (adult or child)
as those used for defibrillation. The frequency and current of the pacemaker
pulses are defined by the user. There are two pacemaker modes as follows:
– Fix: The pacemaker pulse is delivered at a fixed frequency and current level de-
fined by the user.
– On demand: Current level and frequency are defined by the user. The unit mon-
itors the ECG signal and generates pacemaker pulses if the pulse rate falls be-
low the defined value.
Depending on their configuration, the monitoring function of the
DEFIGARD®Touch 7 & PHYSIOGARD®Touch 7 delivers the most important
parameters – ECG, SpO2, SpCO, SpMet, CO2 – and allows continuous
monitoring of the patient from the beginning to the end of an intervention.
The devices are intended for single patient use only.
The devices are designed to meet the specific needs of ground and air rescue
services as well as in-house and inter-hospital transportation.
The devices can be used for adults, children and neonates with the
corresponding accessories.
ECG
The ECG is used to diagnose cardiac abnormalities, acute myocardial
ischaemia and infarctions in chest pain patients.

1 Safety notes
1.3 Contraindication for use
Page 10
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
1.3 Contraindication for use
NIBP
The NIBP monitor is intended for use as an aid or adjunct to diagnosis and
treatment when it is necessary to measure an adult, child and neonate patient’s
blood pressure. The NIBP can be used for patients of both sexes and all races.
This NIBP can be used on pregnant patients or patients suffering from pre-
eclampsia
IBP
Invasive blood pressure: systolic, diastolic and mean pressure.
SpO2, SpCO, SpMet
The Masimo Rainbow SET® Pulse CO sensor is indicated for use with adult and
paediatric patients during both no-motion and motion conditions, and for patients
who are well or poorly perfused.
etCO2
The IRMA mainstream sensor is intended to be connected to a patient breathing
circuit for the continuous non invasive monitoring of breath rate and inspired/
expired gases during anaesthesia, recovery and respiratory care.
The ISA gas analyser is intended to be connected to a patient breathing circuit
for the continuous non invasive sidestream monitoring of breath rate and
inspired/expired gases during anaesthesia, recovery and respiratory care.
The CO2sensors are intended for use with adult, paediatric and infants
populations.
Defibrillation (DEFIGARD®Touch 7)
The defibrillator of the DEFIGARD®Touch 7 must not be used in automated
mode (AED) when the person:
– is responsiv
– is breathing normally
– has pulse
Do not use the device in or near magnetic resonance imaging equipment (MRI).
Danger of explosion! — The device must not be used in areas where there is
any danger of explosion. There might be a danger of explosion in areas where
flammable products (petrol), flammable anaesthetic agents or products for skin
cleaning/disinfection are in use, or where the ambient air's oxygen concentration
is higher than 25 %.

Page 11
Safety notes 1
User guide Responsibility of the User 1.4
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
1.4 Responsibility of the User
1.5 Organisational Measures
The numerical and graphical results and any interpretation given must be
examined with respect to the overall clinical condition of the patient and the
general recorded data quality.
The indications given by this equipment are not a substitute for regular checking
of vital functions.
Always ensure that the screen/alarm LED of the device can be seen in case the
audible alarms cannot be heard or are turned off (see chapter 4.2.2 Operator’s
position page 38).
The AED of the DEFIGARD®Touch 7 must only be used if the following
symptoms are present:
– not responsive
– not breathing normally
– no pulse
Make sure that the user has read and understood the user guide, and especially
these safety notes.
Operating a device with a defective casing, defective cables and sensors
constitutes a danger to the patient or the user! Therefore:
– Immediately replace a damaged unit, damaged cables, sensors and connec-
tions. Damaged or missing components must be replaced immediately.
The device including sensor and accessories must be serviced on a regular
basis. (see chapter 10.1.1 page 112)
The DEFIGARD®Touch 7 is an emergency device and must be ready for
operation at any time and in all situations. Ensure that the device is always
equipped with a sufficiently charged battery and keep a spare battery at hand.
Properly dispose of the package material and make sure it is out of children's
reach.
Before using the unit, ensure that an introduction regarding the unit functions
and the safety precautions has been provided and understood.
Always store the user guide at hand near the device. Make sure that the
instructions are always complete and legible.

1 Safety notes
1.6 Safety-Conscious Operation
Page 12
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
1.6 Safety-Conscious Operation
This user guide, and especially these safety notes, must be read and observed.
Danger of electric shock!
The energy applied to the patient can be conducted through the patient to other
persons, who may suffer a lethal electric shock. Therefore:
– Do not touch the patient, the electrodes or other conducting objects during
defibrillation
– Do not defibrillate the patient in a puddle of water or on other conductive
surfaces
– Switch the device off when it is no longer used.
To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
To grant the patient's safety, it must be ensured that neither the electrodes,
including the neutral electrode, nor the patient, or persons touching the patient,
come into contact with conducting objects, even if these are earthed.
Immediately report any changes that impair safety (including operating
behaviour) to the person responsible.
Only connect original SCHILLER accessories to the device.
Before switching on, check if the unit's casing and electrode connection are
undamaged.
Only operate the device in accordance with the specified technical data.
Do not expose the device to great temperature variations over a long period of
time. Major temperature variations can cause condensation water on the unit.
Should condensing water nevertheless occur, dry the unit, the defibrillation
electrodes and all connections.
In case of strong water/liquid spraying onto the device, check the absence of
water/liquid in the battery compartment. If necessary, please remove the battery,
dry water from compartment and replace battery.
Special caution must always be taken on intracardiac application of medical
equipment. Especially make sure that no conducting parts connected to the
unit's isolated patient input (patient, plug, electrodes, sensor) come into contact
with other, earthed conductive objects, as this might short-out the patient's
isolation and remove the protection of the isolated input.
Carefully route patient cabling to reduce the possibility of patient entanglement
or strangulation.
The user shall always remain close to the patient during monitoring.
Do not place the device where the device can be controlled by the patient.
Position the device so that there is no possibility of it falling on the patient or
floor.
Do not reuse disposable accessories marked with the symbol to prevent
cross infection.
If unexpected readings are obtained, the operator should check the connections
and verify the readings according to section 10.2.5 page 115.

Page 13
Safety notes 1
User guide Operation with other Devices 1.7
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
1.7 Operation with other Devices
1.8 Maintenance
Use only accessories and other parts recommended or supplied by SCHILLER.
Use of other than recommended or supplied parts may result in injury,
inaccurate information and/or damage to the unit.
The patient can be endangered by too high leakage currents (summation of
leakage currents) if:
– several devices are connected to the patient
– other equipment is connected to the DEFIGARD®Touch 7 or
PHYSIOGARD®Touch 7.
For this reason, devices that are not required should be disconnected from the
patient, and only equipment approved by SCHILLER may be connected to the
device.
Accessory equipment connected to the analogue and digital interfaces must be
certified according to the respective IEC standards (e.g. IEC/EN 60950 for data
processing equipment and IEC/EN 60601-1 for medical equipment).
Furthermore all configurations shall comply with the valid version of the system
standard IEC/EN 60601-1. Everyone who connects additional equipment to the
signal input part or signal output part configures a medical system, and is
therefore responsible that the system complies with the requirements of the valid
version of the system standard IEC/EN 60601-1. If in doubt, consult the technical
service department or your local representative.
Magnetic and electrical fields of X-ray equipment, tomographs, portable
communication devices, HF radios and devices labelled with the symbol
can affect the operation of this device. (See section 10.9.3 Measures to prevent
electromagnetic interferences page 126.) Avoid using such devices or keep a
sufficient distance from them.
The charging of energy and the release of the defibrillation impulse can disturb
other devices. Check these devices before their further use.
Sensors and devices that are not defibrillation proof must be disconnected from
the patient before a shock is triggered.
If the patient has a pacemaker implanted, do not position the electrode directly
onto the pacemaker. Check the pacemaker after the defibrillation.
The DEFIGARD®Touch 7 & PHYSIOGARD®Touch 7 can be used together with
high-frequency electrosurgical devices. However, precautions must be
observed when such HF equipment is used. To reduce the risk of burns in the
case of a failure of the neutral HF electrode, a distance of at least 15 cm must
always be kept between the defibrillation electrodes and the HF surgical
electrodes. If in doubt, disconnect the electrodes and sensors from the unit
during use of a HF surgical device. In addition, it may affect the accuracy or
availability of the oximeter measurements.
Danger of electric shock! Do not open the device. No serviceable parts inside.
Refer servicing to qualified personnel only.
No modification of this equipment including sensor and accessories is allowed.
Before cleaning, switch the unit off and remove the battery.
Do not use high temperature sterilisation processes
(such as autoclaving). Do not use E-beam or gamma radiation sterilisation.
Do not use solvent or abrasive cleaners on either the unit or cable assemblies.
Do not, under any circumstances, immerse the unit or cable assemblies in liquid.

1 Safety notes
1.9 Hygiene
Page 14
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
1.9 Hygiene
1.10 Networks and Internet
For cleaning and disinfection observe the legal requirements applicable.
Only use cleaning agents and disinfectants recommended by SCHILLER.
Unsuitable agents can damage the device. Clean and disinfect the device in
accordance with the instructions given in this book.
When the unit is part of a network, (LAN, WLAN, HIS, etc.), transmitting over a
telephone network or any other transmission/reception medium, or if exposed to
the Internet or other insecure networks, appropriate security measures must be
taken to protect the stored patient data.
SCHILLER takes no responsibility for the configuration of Windows.
Patient data security and security of the network is the sole responsibility of the
user.
In order to guarantee the security of the network, Schiller recommends the
following:
– isolating the DEFIGARD®Touch 7 or PHYSIOGARD®Touch 7 network from
other networks
– defining access authorisation for the configuration of the host system, incl.
DEFIGARD®Touch 7 or PHYSIOGARD®Touch 7, so that no unauthorised al-
terations of the system are possible
– limiting the data transmission between the host and other systems/networks to
a minimum

Page 15
Safety notes 1
User guide Additional Terms 1.11
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
1.11 Additional Terms
1.11.1 Implied Authorisation
Possession or purchase of this device does not convey any express or implied license
to use the device with unauthorized sensors or cables which would, alone or in
combination with this device, fall within the scope of one or more of the patents
relating to this device.
1.11.2 Terms of Warranty
Your SCHILLER DEFIGARD®Touch 7 & PHYSIOGARD®Touch 7 is warranted
against defects in material and manufacture according the general term of conditions.
Excluded from this guarantee is damage caused by an accident or as a result of
improper handling. The warranty entitles free replacement of the defective part. Any
liability for subsequent damage is excluded. The warranty is void if unauthorised or
unqualified persons attempt to make repairs.
In case of a defect, send the apparatus to your dealer or directly to the manufacturer.
The manufacturer can only be held responsible for the safety, reliability, and
performance of the apparatus if:
• assembly operations, extensions, readjustments, modifications, or repairs are
carried out by persons authorised by him, and
•theDEFIGARD®Touch 7/PHYSIOGARD®Touch 7 and approved attached
equipment is used in accordance with the manufacturer's instructions.
There are no express or implied warranties which extend beyond the warranties
hereinabove set forth. SCHILLER makes no warranty of merchantability or fitness for
a particular purpose with respect to the product or parts thereof.

1 Safety notes
1.12 Display Symbols/Indicators
Page 16
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
1.12 Display Symbols/Indicators
1.12.1 Symbols Used in this User Guide
The safety level is classified according to ISO 3864-2. The following overview
contains the safety symbols and pictorals used in this user guide.
Touch-sensitive areas
This symbol is used to designate touch-sensitive areas that might not be self-evident.
Touch (to open/close menus and perform functions)
Move up or down.
Move to the right or left
For a direct danger which could lead to severe personal injury or to death.
For a possibly dangerous situation, which could lead to heavy bodily injury or to death.
For a possibly dangerous situation which could lead to personal injury. This symbol is
also used to indicate possible damage to property.
For general safety notes as listed in this section.
Used for electrical dangers, warnings and other notes in regarding operation with
electricity.
NOTE for possibly dangerous situations which could lead to damages to property or
system failure or IMPORTANT for helpful user information.
Reference to other guidelines

Page 17
Safety notes 1
User guide Display Symbols/Indicators 1.12
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
1.12.2 Symbols used on the device
BF symbol. The device's signal input is defibrillation protected.
Signal input type CF: Highly isolated port, defibrillation protected. However, it is only
defibrillation protected when used with the original SCHILLER patient cable.
Notified body of the CE certification (G-MED)
Note accompanying documents!
• Symbol for the recognition of electrical and electronic equipment.
• The device must be disposed of in a municipally approved collection point or
recycling centre when it is no longer required.
• Improper disposal harms the environment and human health due to the presence
of dangerous substances in electrical and electronic equipment.
Manufacturer symbol, manufacturing date
Read the instruction for use
Devices with WLAN or GSM
Attention: Non-ionic electromagnetic environment. The device contains an HF
transmitter.
The DEFIGARD/PHYSIOGARD Touch 7 radiates high-frequency electromagnetic
energy during telemetric ECG data transfer and can disturb other devices if not
installed and operated in accordance with the user guide.
However, even in the case of correct installation/operation, there is no guarantee that
no interferences can occur.
If the DEFIGARD/PHYSIOGARD Touch 7 causes interferences, these can be
prevented by switching off or not sending ECGs.
The user can take the following measures to solve this problem:
• Increase the distance between the disturbed device and the DEFIGARD/
PHYSIOGARD Touch 7. A minimum distance of 20 cm must be kept between the
device and a pacemaker.
• Turn the device to change the antenna's angle of radiation.
• Connect the device to a different mains connector.
For more details, see section 10.9.3 Measures to prevent electromagnetic
interferences page 126.

1 Safety notes
1.12 Display Symbols/Indicators
Page 18
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
1.12.3 Symbols Used on the Batteries
Common symbols
Power battery (Li-Ion)
Safety primary cell (Li/MnO2)
IP55 The device is protected against dust and spraying water from all directions.
Used for electrical dangers during defibrillation (DEFIGARD®Touch 7)
The unit/component can be recycled.
Battery may not be disposed of with domestic refuse.
Do not burn, saw up or crash the battery
Do not short-circuit the battery
Expiration date
Rechargeable battery
Storage temperature for the power battery:
Unlimited: -10...+40 °C
Limited: -20...+65 °C for 48 hours
Non rechargeable battery
Storage temperature for the primary cell:
Unlimited: 15...+25 °C
Limited: 0...+60 °C for 48 hours
Read the instruction for use

Page 19
Safety notes 1
User guide Display Symbols/Indicators 1.12
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
1.12.4 Symbols Used on the Electrode Package
This applies only to the DEFIGARD®Touch 7.
• Open clothes
• Open the electrode package
• Peel off the protective foil
Disposable item; Single use only
Do not bend packing
Storage temperature for the electrodes
Expiration date
Read instruction before use
Latex free
Use within 1 day after opening
Keep dry
Keep out of direct sunlight

2 Components and Operation
2.1 Design
Page 20
Art. no.: 0-48-0227 Rev.: g
DEFIGARD/PHYSIOGARD Touch 7
2 Components and Opera-
tion
The DEFIGARD®Touch 7 is a lightweight mains and battery powered defibrillator
featuring an ECG monitor, SpO2/SpCO/SpMet, etCO2,Temperature and NIBP
measurements. It is designed for clinical use. Defibrillation is possible in non-
synchronised or synchronised mode.
Moreover, the device can be switched to automated defibrillation (AED operation) by
pressing a single key
The PHYSIOGARD®Touch 7 includes the same features as the DEFIGARD®Touch
7, but without the defibrillation function.
2.1 Design
Power supply The DEFIGARD®Touch 7 and PHYSIOGARD®Touch 7 is powered by an integrated
rechargeable battery. The capacity of one battery is sufficient for:
DEFIGARD®Touch 7 • 100 shocks with maximum energy or
• >6 hours of monitoring
PHYSIOGARD®Touch 7 • >6 hours of monitoring
The battery is recharged by an external DC supply.
Defibrillator The DEFIGARD®Touch 7 is a defibrillator featuring biphasic pulsed defibrillation
impulse – Multipulse Biowave®. The defibrillation is done using disposable
adhesive electrodes (pads), which also measure the ECG signal for the analysis.
Adhesive electrodes for children and adults are available. The device recognises the
connected electrodes and selects the defibrillation energy levels accordingly. In the
AED mode, the user will be given visual and audible instructions (display/
loudspeaker).
Monitoring According to its configuration, the DEFIGARD®Touch 7 and PHYSIOGARD®Touch
7monitoring function gives all important parameters – ECG, SpO2/SpCO/SpMet,
etCO2, RR, NIBP, IBP and Temperature. The parameters are indicated in figures and
as waveforms on the large 7” (800x480) LCD display.
Data storage All intervention data – resting ECG data, lead II ECG, defibrillator ECG, SpO2 curves,
trends, events, patient data.
Data transmission • Easy transmission of a 12-lead ECG, trends and screenshots by WLAN or GSM
during intervention
• GSM, WLAN, Ethernet (via USB adapter) Communication, for software and
configuration updates and post-intervention data (PDF or Sema format)
transmissions.
Biocompatibility
The parts of the product described in this user guide, including all accessories, that
come in contact with the patient during the intended use, fulfil the biocompatibility
requirements of the applicable standards. If you have questions in this matter, please
contact SCHILLER.