DERIGARD & PHYSIOGARD TOUCH 7 User Guide rev 0-48-0227g Feb 2018

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: [email protected]

Manufacturer SCHILLER MEDICAL 4, rue Louis Pasteur F- 67160 Wissembourg Web:

Phone +33 3 88 63 36 00 Fax +33 3 88 94 12 82 E-mail: [email protected] www.schiller-medical.fr

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 compliance with the essential requirements of the Annex I of the Medical Device Directive 93/42/EE regarding safety, functionality and labelling. The requirements apply to patients, users and third persons 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 compliance with the essential requirements of the Annex I of the Medical Device Directive 93/42/EE regarding safety, functionality and labelling. The requirements apply to patients, users and third persons 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

DEFIGARD/PHYSIOGARD Touch 7

User guide

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

Art. no.: 0-48-0227 Rev.: g

1.11.1 Implied Authorisation... 15 1.11.2 Terms of Warranty ... 15

1.12

Display Symbols/Indicators... 16

1.12.1 1.12.2 1.12.3 1.12.4

Symbols Used in this User Guide ... 16 Symbols used on the device ... 17 Symbols Used on the Batteries... 18 Symbols Used on the Electrode Package... 19

2

Components and Operation ... 20

2.1

Design... 20

2.1.1 2.1.2

Standard unit and options ... 21 Additional accessories ... 21

2.2

Operating Elements... 22

2.2.1 2.2.2 2.2.3 2.2.4 2.2.5

Front panel DEFIGARD®Touch 7 ... 22 Front panel PHYSIOGARD®Touch 7... 23 Back Panel ... 24 LEDs ... 24 Display ... 25

3

Initial Operation ... 26

3.1

External DC supply and Battery Operation ... 26

3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6

External DC Supply Operation ... 26 Battery Operation ... 27 Operation with external constant voltage source ... 28 Operation ambulance charging bracket ... 29 Operation of the desktop charging bracket ... 29 Operation and fixing during intervention ... 30

3.2 31

Switching off and disconnecting from the external DC supply

3.2.1 3.2.2 3.2.3 3.2.4

Lock Touch screen... 31 Internal safety discharge ... 31 Interruption of external power supply ... 31 Ensuring Operational Readiness ... 32

3.3

Operation... 33

3.4

Printing ... 34

3.4.1 3.4.2

Pairing Bluetooth devices... 34 Brother Printer Overview... 34 Page 3

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 4.2.2 4.2.3 4.2.4 4.2.5

Alarm priority... 38 Operator’s position... 38 Alarm list ... 38 Physiological alarms ... 39 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 4.4.2 4.4.3 4.4.4 4.4.5 4.4.6 4.4.7 4.4.8 4.4.9 4.4.10

Quick Diagnosis of the ECG Using Defibrillation Electrodes ... 43 Connecting a 4- or 10-wire ECG patient cable ... 43 Connecting a 4-wire ECG patient cable... 44 Connecting a 10-wire ECG patient cable... 44 Starting ECG monitoring ... 45 Monitoring a pacemaker patient... 46 Curve list ... 47 HR Module (ECG)... 47 ECG messages... 47 Print and pdf formats... 48

4.5

Diagnostic ECG (R-ECG)... 49

4.6 4.6.1 4.6.2 4.6.3 4.6.4

SpO2-, SpCO, SpMet monitoring (Option) ... 50 Inaccurate or incorrect measurement result ... 51 Starting SpO2 monitoring and test... 52 SpO2 Module ... 52 SpO2error and information messages ... 53

4.7

NIBP monitoring ... 55

4.7.1 4.7.2 4.7.3

Starting NIBP monitoring ... 57 NIBP Menu... 58 NIBP Information and Error Messages ... 58

4.8

IBP Monitoring ... 59

4.8.1 4.8.2 4.8.3 4.8.4 4.8.5

Preparing an IBP measurement... 59 Start IPB measurements... 60 IBP menu settings... 60 IBP zeroing ... 61 IBP alarms/messages ... 61

4.9

Temperature monitoring ... 62

4.9.1 4.9.2 4.9.3

Start temperature monitoring ... 62 Temperature menu settings ... 62 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 CO2 sensor... 66 4.10.6 Sensor LED indications... 67 4.10.7 Settings etCO2 menu... 67 4.10.8 Curve list ... 67 4.10.9 CO2 error messages... 68

Page 4

Art. no.: 0-48-0227 Rev.: g

DEFIGARD/PHYSIOGARD Touch 7

DEFIGARD/PHYSIOGARD Touch 7

User guide

4.11 4.11.1 4.11.2 4.11.3 4.11.4 4.11.5 4.11.6 4.11.7

CO2 Sidestream ... 69 ISA gas analyser (sidestream measurement) ... 69 Initial operation of the ISA gas analyser... 71 Sensor LED indications... 71 Respiration rate alarms ... 72 Settings etCO2 menu... 73 Curve list ... 73 Zero adjustment of the CO2 sidestream 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

Art. no.: 0-48-0227 Rev.: g

5

Defibrillation ... 78

5.1

Application guidelines and safety notes ... 78

5.1.1 5.1.2

Additional safety information for AED Mode ... 79 Defibrillating children/neonates ... 80

5.2

General function ... 81

5.2.1 5.2.2 5.2.3

Activating the manual defibrillation mode... 82 Activating the automated (AED) defibrillation mode... 83 Manual defibrillation procedure ... 84

5.3

Manual Defibrillation Using Pads... 85

5.3.1 5.3.2 5.3.3 5.3.4

Applying the adult and paediatric electrodes ... 85 Applying the electrodes... 86 Checking the electrodes... 87 Manual Defibrillation Using Pads Procedure... 88

5.4

Synchronised defibrillation ... 89

5.4.1 5.4.2 5.4.3 5.4.4

Warning erroneous triggering... 89 Setup switching from synchronized to unsynchronized mode ... 89 Function of the Synchronized Defibrillation Procedure ... 90 Synchronised defibrillation procedure ... 91

5.5

Semi-automated defibrillation ... 92

5.5.1 5.5.2 5.5.3

Semi-automated defibrillation (AED) procedure... 92 Voice messages in AED Mode... 93 Defibrillation procedure ... 94

5.6

CPR Guide... 96

5.6.1 5.6.2 5.6.3

SCHILLER LifePoint... 96 FreeCPR ... 97 Metronome settings... 97

5.7

Defibrillator Technical Messages... 98

Page 5

DEFIGARD/PHYSIOGARD Touch 7

6

Pacemaker ...99

6.1

Pacemaker Function... 99

6.1.1 6.1.2

Fixed-rate mode (Fix)... 99 Demand mode ... 99

6.2

Safety Notes ... 100

6.3

Guidelines for the Application of External Pacemakers 100

6.3.1 6.3.2

Attaching the pacer pads ... 101 Checking the electrodes ... 101

6.4

Start-up of the Pacemaker ... 102

6.4.1 6.4.2 6.4.3 6.4.4 6.4.5

Pacemaker display... 103 Selecting pacemaker mode ... 103 Pacemaker settings operational mode fix ... 104 Demand Mode ... 105 Switching from pacemaker to defibrillation ... 105

7

Finishing the Therapy ...106

8

Intervention summary ...107

8.1

Post-intervention ... 108

8.1.1 8.1.2 8.1.3

Reviewing intervention file on the device... 108 Transmitting the intervention file ... 108 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

Page 6

10.2

Functional test ... 114

10.2.1 10.2.2 10.2.3 10.2.4 10.2.5 10.2.6

Visual inspection of the device and accessories... 114 Battery check ... 114 Defibrillator key test ... 114 Auto Test ... 115 Functional test - measured values ... 115 Alarm tests ... 115

10.3

Update Software ... 117

10.3.1 10.3.2

Update via USB ... 117 Update via Server ... 117

10.4

Maintenance interval of the batteries ... 118

10.4.1 10.4.2

Replacing the batteries ... 118 Battery disposal ... 118

10.5

Cleaning... 119

10.5.1

Detergents ... 119

10.6

Disinfection ... 120

10.6.1 10.6.2

Disinfectant ... 120 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

Art. no.: 0-48-0227 Rev.: g

10.1.1 Maintenance Interval Table... 112 10.1.2 Service/Shelf life ... 113

DEFIGARD/PHYSIOGARD Touch 7

User guide

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

Art. no.: 0-48-0227 Rev.: g

12.2.1 Shock Advisory System ... 137

12.3

Pacemaker... 138

12.4

Technical data - monitoring... 139

12.4.1 12.4.2 12.4.3 12.4.4 12.4.5 12.4.6 12.4.7

ECG ... 139 Features of pacemaker pulse rejection ... 140 NIBP - non-invasive blood pressure... 141 IBP - invasive blood pressure ... 141 Temperature... 141 SpO2 - pulsoximetry... 142 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

Page 7

DEFIGARD/PHYSIOGARD Touch 7

12.7.2 12.7.3

Electromagnetic immunity... 156 Recommended minimum distances... 158

13

Appendix ...159

13.1

Accessories and disposables ... 159 Accessories DEFIGARD/PHYSIOGARD Touch 7... 159 Literature ... 161

13.4

Glossary ... 161

14

Index ...163

Art. no.: 0-48-0227 Rev.: g

13.2 13.3

Page 8

DEFIGARD/PHYSIOGARD Touch 7

User guide

Safety notes User profiles

1 1.1

1 Safety notes The PHYSIOGARD® Touch 7 is a monitor. The DEFIGARD® Touch 7 is an emergency monitor / defibrillator.

1.1 Physician

User profiles 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 Defibrillator

Art. no.: 0-48-0227 Rev.: g

 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 defined by the user. – On demand: Current level and frequency are defined by the user. The unit monitors the ECG signal and generates pacemaker pulses if the pulse rate falls below 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.

Page 9

1 1.3

Safety notes Contraindication for use

DEFIGARD/PHYSIOGARD Touch 7

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 preeclampsia 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 





1.3

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 CO2 sensors are intended for use with adult, paediatric and infants populations.

Contraindication for use 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 %.

Art. no.: 0-48-0227 Rev.: g



Page 10

DEFIGARD/PHYSIOGARD Touch 7

1.4

User guide

Safety notes Responsibility of the User

1 1.4

Responsibility of the User  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 connections. 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.

1.5

Organisational Measures

Art. no.: 0-48-0227 Rev.: g

 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.

Page 11

1 1.6

Safety notes Safety-Conscious Operation

1.6

DEFIGARD/PHYSIOGARD Touch 7

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.  

Page 12

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.

Art. no.: 0-48-0227 Rev.: g

 

DEFIGARD/PHYSIOGARD Touch 7

1.7

User guide

Safety notes Operation with other Devices

1 1.7

Operation with other Devices  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.

Art. no.: 0-48-0227 Rev.: g

 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.

1.8

Maintenance  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.

Page 13

1 1.9

Safety notes Hygiene

DEFIGARD/PHYSIOGARD Touch 7

1.9

Hygiene  

1.10

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.

Networks and Internet 

  

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:

Art. no.: 0-48-0227 Rev.: g

– 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 alterations of the system are possible – limiting the data transmission between the host and other systems/networks to a minimum

Page 14

DEFIGARD/PHYSIOGARD Touch 7

User guide

1.11

Additional Terms

1.11.1

Implied Authorisation

Safety notes Additional Terms

1 1.11

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 • the DEFIGARD® Touch 7/PHYSIOGARD® Touch 7 and approved attached equipment is used in accordance with the manufacturer's instructions.

Art. no.: 0-48-0227 Rev.: g

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.

Page 15

1 Safety notes 1.12 Display Symbols/Indicators

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. 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

Touch-sensitive areas This symbol is used to designate touch-sensitive areas that might not be self-evident.

Move up or down.

Move to the right or left

Page 16

Art. no.: 0-48-0227 Rev.: g

Touch (to open/close menus and perform functions)

DEFIGARD/PHYSIOGARD Touch 7

1.12.2

User guide

Safety notes Display Symbols/Indicators

1 1.12

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.

Art. no.: 0-48-0227 Rev.: g

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.

Page 17

1 Safety notes 1.12 Display Symbols/Indicators

IP55

DEFIGARD/PHYSIOGARD Touch 7

The device is protected against dust and spraying water from all directions.

Used for electrical dangers during defibrillation (DEFIGARD® Touch 7)

1.12.3

Symbols Used on the Batteries Common symbols 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

Power battery (Li-Ion) Rechargeable battery

Storage temperature for the power battery: Unlimited: -10...+40 °C Limited: -20...+65 °C for 48 hours Safety primary cell (Li/MnO2)

Storage temperature for the primary cell: Unlimited: 15...+25 °C Limited: 0...+60 °C for 48 hours Read the instruction for use

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Art. no.: 0-48-0227 Rev.: g

Non rechargeable battery

DEFIGARD/PHYSIOGARD Touch 7

1.12.4

User guide

Safety notes Display Symbols/Indicators

1 1.12

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

Art. no.: 0-48-0227 Rev.: g

Keep out of direct sunlight

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2 2.1

Components and Operation Design

DEFIGARD/PHYSIOGARD Touch 7

2 Components and Operation 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 nonsynchronised 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. 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.

2.1

Design 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

PHYSIOGARD® Touch 7

• 100 shocks with maximum energy or • >6 hours of monitoring • >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 7 monitoring 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.

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Art. no.: 0-48-0227 Rev.: g

Power supply