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DEFIGARD 5000®

Defibrillator and Monitor


*0-48-0060*
Art. no.: 0-48-0060 Rev.: a

User Guide
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 a complete list of all distributors and subsidiaries is provided on our
internet site:
http://www.schiller.ch
Sales information can also be obtained from:
[email protected]

Manufacturer
SCHILLER Médical S.A.S. Tel: + 33 3 88 63 36 00
4, rue Louis Pasteur Fax: +33 3 88 94 12 82
F-67162 Wissembourg E-mail: [email protected]
Web: www.schiller.fr

Address headquarters
SCHILLER AG Tel: +41 (0) 41 766 42 42
Altgasse 68 Fax: +41 (0) 41 761 08 80
CH-6341 Baar, Switzerland E-mail: [email protected]
Web: www.schiller.ch

Article no.: 0-48-0060 Rev.: a


Issue date: 05.12.05
S.Art.no.: 2.510599
DEFIGARD 5000 User Guide

Table of Contents
1 Safety Notes .............................................. 5
1.1 Responsibility of the User .................................................. 5
1.2 Intended Use ........................................................................ 5
1.3 Organisational Measures..................................................... 6
1.4 Operational Precautions ...................................................... 6
1.5 Operation with other Devices .............................................. 7
1.6 Maintenance .......................................................................... 7
1.7 General Safety Notes ........................................................... 8
1.8 Additional Terms .................................................................. 8
1.8.1 Implied Authorisation.......................................................................... 8
1.8.2 Terms of Warranty ............................................................................. 8
1.9 Display Symbols/Indicators................................................. 9
1.9.1 Symbols Used in this User Guide ...................................................... 9
1.9.2 Symbols Used on the Device ........................................................... 10
1.9.3 Symbols Used on the Battery........................................................... 10
1.9.4 Symbols Used on the Electrode Package........................................ 11

2 Components and Operation .................. 12


2.1 Design.................................................................................. 12
2.1.1 Available Options ............................................................................. 13
2.1.2 Overview of the Configurable Settings............................................. 13
2.2 Operating Elements............................................................ 14
2.2.1 Front Side......................................................................................... 14
2.2.2 Back Panel ....................................................................................... 15
2.2.3 Paddle Operation Elements ............................................................. 16
2.2.4 LEDs ................................................................................................ 16
2.2.5 Display ............................................................................................. 17

3 Start-up and Initial Preparation ............. 18


3.1 Mains and Battery Operation............................................. 18
3.1.1 Connecting the Unit to the Mains and Switching it on...................... 18
3.1.2 Battery Operation ............................................................................. 19
3.1.3 Operation with External Constant Voltage Source........................... 19
3.2 Switching off and Disconnecting from Mains.................. 20
3.2.1 Internal Safety Discharge................................................................. 20
3.2.2 Mains Supply Interruption ................................................................ 20
Art. no.: 0-48-0060 Rev.: a

3.2.3 Ensuring Operational Readiness ..................................................... 20


3.3 Inserting Printing Paper .................................................... 21
3.4 Operation............................................................................. 22
3.4.1 Direct Menu Access ......................................................................... 22
3.4.2 Accessing Menus and Function Keys via Display Fields ................. 23

4 Monitoring ............................................... 24
4.1 Softkeys, Waveforms and Measurement Fields .............. 24
4.2 Alarm Messages ................................................................. 25
4.3 ECG and Heart Rate Monitoring ........................................ 26

Page 1
DEFIGARD 5000

4.3.1 Quick Diagnosis of the ECG Using Defibrillation Electrodes ........... 26


4.3.2 Connecting a 3-Lead ECG Patient Cable ........................................ 26
4.3.3 Connecting a 4- or 10-Lead ECG Patient Cable.............................. 27
4.3.4 Starting ECG Monitoring .................................................................. 28
4.3.5 Monitoring a Pacemaker Patient...................................................... 28
4.3.6 ECG Menu ....................................................................................... 29
4.3.7 ECG Error Messages....................................................................... 29
4.4 SPO2 Monitoring................................................................. 30
4.4.1 Starting SpO2 Monitoring and Test.................................................. 30
4.4.2 SpO2 Menu...................................................................................... 31
4.4.3 SpO2 Error Messages ..................................................................... 31
4.5 NIBP Monitoring.................................................................. 32
4.5.1 Starting NIBP Monitoring ................................................................. 33
4.5.2 NIBP Menu....................................................................................... 34
4.5.3 NIBP Error Messages ...................................................................... 34
4.6 Trend Display ...................................................................... 35
4.6.1 Displaying Trends ............................................................................ 35
4.6.2 Deleting the Trend Memory ............................................................. 37
4.6.3 Transmitting the Event Memory ....................................................... 37

5 Defibrillation ............................................38
5.1 Rules and Safety Notes...................................................... 38
5.1.1 Additional Safety Notes for SAED Mode.......................................... 39
5.1.2 Defibrillating Children....................................................................... 39
5.2 General Function ................................................................ 40
5.2.1 Activating the Manual or Automatic Defibrillation Mode................... 40
5.2.2 Manual Defibrillation - Procedure..................................................... 40
5.3 Manual Defibrillation Using Paddles................................. 41
5.3.1 Marking Events ................................................................................ 41
5.4 Manual Defibrillation Using Pads...................................... 42
5.4.1 Applying the Pads ............................................................................ 42
5.4.2 Checking the Electrodes .................................................................. 43
5.4.3 Manual Defibrillation Using Pads - Procedure ................................. 44
5.5 Internal Defibrillation.......................................................... 45
5.6 Synchronised Defibrillation ............................................... 46
5.6.1 Switching to Synchronised Defibrillation .......................................... 46
5.6.2 Synchronised Defibrillation – Procedure.......................................... 47
5.7 Semiautomatic Defibrillation ............................................. 48
5.7.1 Semiautomatic Defibrillation (SAED) – Procedure........................... 48
5.7.2 Defibrillation - Procedure ................................................................. 51
5.8 Defibrillator Error Messages.............................................. 53

6 Pacemaker ...............................................54
Art. no.: 0-48-0060 Rev.: a

6.1 Pacemaker Function........................................................... 54


6.1.1 Fixed-Rate Mode (Fix) ..................................................................... 54
6.1.2 Demand Mode ................................................................................. 54
6.1.3 Overdrive Mode ............................................................................... 54
6.2 Safety Notes ........................................................................ 55
6.3 Guidelines for the Application of External Pacemakers . 55
6.3.1 Attaching the Pacer Pads ................................................................ 56
6.4 Start-up of the Pacemaker ................................................. 57
6.4.1 Pacemaker Display .......................................................................... 57
6.4.2 Selecting Pacemaker Mode ............................................................. 57

Page 2
DEFIGARD 5000 User Guide

6.4.3 Pacemaker Settings Operational Mode Fix...................................... 58


6.4.4 Demand Mode.................................................................................. 58
6.4.5 Overdrive Mode................................................................................ 59

7 Finishing the Therapy ............................ 60

8 Intervention Summary ........................... 61


8.1 Printing Curves and Measured Values ............................. 62
8.1.1 Example of a Defibrillator Shock Printout......................................... 62
8.1.2 Printer Error Messages .................................................................... 62

9 Default and User-Defined Thresholds .. 63


9.1 User-Defined Thresholds ................................................... 64
9.1.1 ECG Menu ....................................................................................... 64
9.1.2 SpO2 Menu ........................................................................................ 64
9.1.3 NIBP Menu....................................................................................... 65
9.1.4 User-Defined Thresholds Menu ................................................... 65
9.1.5 Unit Settings Menu ........................................................................ 66

10 Default Values ......................................... 67


10.1 Default Threshold Values for Adults ................................ 67
10.2 Default Threshold Values for Neonates ........................... 67
10.3 Default Device Settings ..................................................... 68
10.3.1 Alarms .............................................................................................. 68
10.3.2 NIBP................................................................................................. 68
10.3.3 Language ......................................................................................... 68
10.3.4 Screen Colour .................................................................................. 68
10.3.5 Mains Filter....................................................................................... 68
10.3.6 Serial Number .................................................................................. 68
10.3.7 Hardware Number............................................................................ 69
10.4 Working Hour Meter .......................................................... 69
10.5 Ethernet ............................................................................... 69
10.6 Options ................................................................................ 69
10.7 Releases .............................................................................. 70
10.8 PC Download ..................................................................... 70
10.9 Locking the Device ............................................................ 70

11 Maintenance ............................................ 71
11.1 Maintenance Interval .......................................................... 71
Art. no.: 0-48-0060 Rev.: a

11.1.1 Visual Unit Check............................................................................. 71


11.1.2 Defibrillator Test ............................................................................... 71
11.1.3 Functional Test................................................................................. 72
11.1.4 Alarm Tests ...................................................................................... 72
11.2 Maintenance Interval for the Battery ................................ 73
11.2.1 Battery Disposal ............................................................................... 73
11.2.2 Disposal at the End of the Device's Useful Life ............................... 73
11.3 Cleaning .............................................................................. 74
11.3.1 Cleaning the Casing......................................................................... 74
11.3.2 Accessories and Disposables .......................................................... 74
11.4 Error Detection ................................................................... 75
11.4.1 General Errors.................................................................................. 75

Page 3
DEFIGARD 5000

11.4.2 Technical Error Messages ............................................................... 76

12 Technical Data ........................................77


12.1 System Data ........................................................................ 77
12.2 Defibrillation Pulse ............................................................. 79
12.3 Technical Data - Measured Values.................................... 81
12.3.1 ECG ................................................................................................. 81
12.3.2 NIBP - Non-Invasive Blood Pressure............................................... 81
12.3.3 SpO2 - Pulsoximetry ........................................................................ 82
12.3.4 Storage of Intervention (Option)....................................................... 82
12.4 Technical Pacemaker Data ................................................ 82

13 Appendix .................................................83
13.1 Accessories DEFIGARD 5000............................................ 83
13.2 Literature ............................................................................. 85
13.3 Glossary .............................................................................. 85

14 Index ........................................................87

Art. no.: 0-48-0060 Rev.: a

Page 4
Safety Notes 1
DEFIGARD 5000 User Guide Responsibility of the User 1.1

1 Safety Notes
1.1 Responsibility of the User
V The device must only be used by qualified physicians or other persons (only
AED mode) trained in early defibrillation.
V The numerical and graphical results as well as any interpretation suggested by
the device must be examined with respect to the patient's overall clinical condi-
tion and the quality of the recorded data.
V The indications given by this equipment are not a substitute for regular checking
of vital functions.
V Make sure that the user has read and understood the user guide, and especially
these safety notes.
V Damaged or missing parts must be replaced immediately.
V It is the owner's responsibility that the valid regulations for safety and prevention
of accidents are observed.
V The device must be stored inaccessible to children.
V Properly dispose of the package material and make sure it is out of children's
reach.

1.2 Intended Use


V The DEFIGARD® 5000 is a defibrillator used for the treatment of ventricular fi-
brillation (VF) and ventricular tachycardia (VT). The DG 5000 additionally has a
pacemaker function. The monitoring side of the DEFIGARD 5000 gives the most
important parameters: ECG, SpO2 and NIBP and allows continuous monitoring
of the patient from the beginning to the end of the intervention.
V The device is only intended for single patient use.
V The DEFIGARD® 5000 is intended for hospital use.
V The device can be used for adults and children with the corresponding accesso-
ry.
V The defibrillator may only be used if the following symptoms are found:
– non-responsive
– no respiration
– no pulse
V The defibrillator must not be used in semiautomatic mode (AED) if the person:
– is responsive
– is breathing
– has pulse
V The DEFIGARD® 5000 is an emergency device that must be ready for use at
Art. no.: 0-48-0060 Rev.: a

any time and in any situation. Make sure that the device is always connected to
the mains or vehicle power supply.
V Only operate the device in accordance with the specified technical data.
V Do not use the device in areas where there is any danger of explosion or in the
presence of flammable gases such as anaesthetic agents.

Page 5
1 Safety Notes
1.3 Organisational Measures DEFIGARD 5000

1.3 Organisational Measures


V Before using the unit, ensure that an introduction regarding the unit functions
and the safety precautions has been provided and understood.
V Always store the user guide handy near the device. Make sure that the user
guide is always complete and readable.
V In addition to this user guide, also legal and other binding regulations for the pre-
vention of accidents and for environment protection must be observed.

1.4 Operational Precautions


V This user guide, and especially these safety notes, must be read and observed.
V 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. For this reason:
– Do not touch the patient, the electrodes or other conducting objects during a de-
fibrillation
– Do not defibrillate the patient in a puddle of water or on other conducting surfac-
es.
– Switch the device off when it is no longer used.
V To grant the patient's safety, it must be ensured that neither the electrodes, in-
cluding the neutral electrode, nor the patient, or persons touching the patient,
come into contact with conducting objects (e.g. RS-232 interface - see Fig. 3.1 on
page 15), even if these are earthed.
V Changes, including concerning operational behaviour, affecting safety must be
immediately reported to the responsible.
V Only connect original SCHILLER accessories to the device.
V Before switching on, check if the unit's casing and electrode connection are un-
damaged.
V Do not expose the device to great temperature variations over a long period of
time. Too great temperature variances can cause condensation water on the
unit. If condensing water should occur nevertheless, dry the unit, the defibrilla-
tion electrodes and all connections.
V Special caution must always be taken on intracardiac application of medical
equipment. Especially make sure that no conducting parts connected to the iso-
lated patient input (patient, plug, electrodes, sensor) come into contact with oth-
er, earthed conductive objects, as this might short-out the patient's isolation and
remove the protection of the isolated input.
V Position the device so that there is no possibility of it falling on the patient or floor. Art. no.: 0-48-0060 Rev.: a

Page 6
Safety Notes 1
DEFIGARD 5000 User Guide Operation with other Devices 1.5

1.5 Operation with other Devices


V Use only accessories and other parts recommended or supplied by SCHILLER
AG. Use of other than recommended or supplied parts may result in injury, inac-
curate information and/or damage to the unit.
V 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 5000
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
DEFIGARD 5000.
V 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). Further-
more, all configurations shall comply with the valid version of the system standard
IEC/EN 60601-1-1. Everyone who connects additional equipment to the signal in-
put part or signal output part configures a medical system, and is therefore re-
sponsible that the system complies with the requirements of the valid version of
the system standard IEC/EN 60601-1-1. If in doubt, consult the technical service
department or your local representative.
V Magnetic and electrical fields of X-ray equipment, tomographs, radio systems,
cellular phones etc. can disturb the unit's function. Avoid using such devices and
keep a sufficient distance from them.
V The charging of energy and the release of the defibrillation impulse can disturb
other devices. Check these devices before their further use.
V Sensors and devices that are not defibrillation proof must be disconnected from
the patient before a shock is triggered.
V If the patient has a pacemaker implanted, do not position the electrode directly
onto the pacemaker. Check the pacemaker after the defibrillation.
V The input terminals of the DEFIGARD® 5000 are protected against the influenc-
es of high-frequency electrosurgical equipment. Nevertheless, precautions must
be observed when high-frequency devices are used at the same time. 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.

1.6 Maintenance
V Danger of electric shock! Do not open the device. No serviceable parts inside.
Refer servicing to qualified personnel only.
V Before cleaning, switch the unit off and remove the battery.
Art. no.: 0-48-0060 Rev.: a

V Do not use high temperature sterilisation processes (such as autoclaving). Do


not use e-beam or gamma radiation sterilisation.
V Do not use aggressive or abrasive cleaners.
V Do not, under any circumstances, immerse the device or cable assemblies in liq-
uid.

Page 7
1 Safety Notes
1.7 General Safety Notes DEFIGARD 5000

1.7 General Safety Notes


V Operating a device with a defective casing or defective cables constitutes a dan-
ger to the patient or user! For this reason:
– Immediately replace a damaged unit, or damaged cables and connections.

1.8 Additional Terms


1.8.1 Implied Authorisation
Possession or purchase of this device does not convey any express or implied li-
cense to use the device with replacement parts which would alone, or in combina-
tion with this device, fall within the scope of one or more patents relating to this de-
vice.

1.8.2 Terms of Warranty


Your SCHILLER DEFIGARD 5000 is warranted against defects in material and man-
ufacture for the duration of one year (as from date of purchase). 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 at-
tempt 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 perform-
ance of the apparatus if:
• assembly operations, extensions, readjustments, modifications, or repairs are car-
ried out by persons authorized by him, and
• the DEFIGARD 5000 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.

Art. no.: 0-48-0060 Rev.: a

Page 8
Safety Notes 1
DEFIGARD 5000 User Guide Display Symbols/Indicators 1.9

1.9 Display Symbols/Indicators


1.9.1 Symbols Used in this User Guide
The hazard levels are classified in accordance with ANSI Z535.4. The following over-
view shows the used safety symbols and pictograms used in this manual.

For an imminently hazardous situation which, if not avoided, will result in death or
serious injury.

For a potentially hazardous situation which, if not avoided, could result in death or
serious injury.

For a potentially hazardous situation which, if not avoided, may result in minor or
moderate injury. It may also be used to alert against damage to equipment.

For general safety notes like those in this chapter.

For electrical hazards, warnings or precautionary measures when dealing with elec-
tricity.

NOTE For possibly dangerous situations, which could lead to damage to property or
system failure or IMPORTANT for helpful user information.

Reference to other user guides.


Art. no.: 0-48-0060 Rev.: a

Page 9
1 Safety Notes
1.9 Display Symbols/Indicators DEFIGARD 5000

1.9.2 Symbols Used on the Device


BF symbol. The device's signal input is defibrillation protected.

Signal input type CF: High-insulation port, suited for intracardiac application, defibril-
lation protected.

Notified body for CE certification. (G-MED)

Note: Follow the instructions in the documentation.

SCHILLER potential equalisation.

Symbol for the recognition of electrical and electronic equipment


The device must be disposed of in a municipally approved collection point or recy-
cling centre when it is no longer required.
Improper disposal harms the environment and human health due to dangerous sub-
stances contained in the equipment.

1.9.3 Symbols Used on the Battery

The unit/component can be recycled.

Battery may not be disposed of with domestic refuse.

Do not burn, saw up or crash the battery.

Rechargeable battery

Do not short the battery


Art. no.: 0-48-0060 Rev.: a

Storage temperature for the battery:


Unlimited: 0...+40 °C

Expiration date

Page 10
Safety Notes 1
DEFIGARD 5000 User Guide Display Symbols/Indicators 1.9

1.9.4 Symbols Used on the Electrode Package


Open the electrode package

Peel off the protective foil

Disposable item; do not reuse

Do not bend packing

Storage temperature for the electrodes

Expiration date
Art. no.: 0-48-0060 Rev.: a

Page 11
2 Components and Operation
2.1 Design DEFIGARD 5000

2 Components and Opera-


tion
The DEFIGARD® 5000 is a lightweight mains and battery powered defibrillator fea-
turing an ECG monitor, a recorder, SpO2 measurement, NIBD and a transcutaneous
pacemaker. It is designed for clinical use. Defibrillation is possible in non-synchro-
nised or synchronised mode.
Moreover, the device can be switched to automatic defibrillation (AED operation) by
pressing a single key.

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 re-
quirements of the applicable standards. If you have questions in this matter, please
contact SCHILLER.

2.1 Design
Power Supply The DEFIGARD® 5000 is either powered by the mains or an integrated rechargeable
battery. The capacity of one battery is sufficient for:
• 190 shocks with max. energy or
• 2 hours monitoring

Defibrillator The DEFIGARD® 5000 is a defibrillator featuring biphasic pulsed defibrillation im-
pulse – Multipulse Biowave®. The defibrillation is done using paddles, disposable
adhesive electrodes (pads) or spoons (internal defibrillation), 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 defibril-
lation energy levels accordingly. In the AED mode, the user will be given visual and
audible instructions (display/loudspeaker).

External cardiac pacemaker The DEFIGARD® 5000 pacemaker function can at any time be activated via the ad-
hesive electrodes. In the menu, the fix, demand and overdrive operational modes
can be selected.

Monitoring The DEFIGARD® 5000 monitoring function gives all important parameters – ECG,
SpO2 and NIBP. The parameters are indicated in figures and as waveforms on the
large LCD display.

Data storage The ECG and trends are saved in the device. Three ECG curves can be printed on
Art. no.: 0-48-0060 Rev.: a

the integrated printer:

Data transmission • Easy transmission of a 12 lead ECG by GSM or standard modem connected to the
back of the device
• USB connector for use with for example, a memory stick to copy the stored data
• Ethernet connector for software updates

Page 12
Components and Operation 2
DEFIGARD 5000 User Guide Design 2.1

2.1.1 Available Options


• Additional battery, type Li/ion; 10.8 V, 4.3 A

2.1.2 Overview of the Configurable Settings


The following settings can be configured by the SCHILLER after-sales service:
• Voice volume
• Energy levels of the first, second and third shocks, individually for adults and chil-
dren
Art. no.: 0-48-0060 Rev.: a

Page 13
2 Components and Operation
2.2 Operating Elements DEFIGARD 5000

2.2 Operating Elements


2.2.1 Front Side

On/off key
Analysis key
Shock key
Loudspeaker
Microphone

Navigation and configuration


key

Paper compartment
release

Softkeys

Paddle
Start printer

Paddle NIBP connection


SpO2 connection
ECG patient cable connection
Art. no.: 0-48-0060 Rev.: a

Fig. 2.1 Control elements of the DG5000's front

Page 14
Components and Operation 2
DEFIGARD 5000 User Guide Operating Elements 2.2

2.2.2 Back Panel

1 2

10 4

8 7 6

Fig. 2.2 Control elements at the DG5000's back

(1) Swing-out fastening bows


(2) Additional battery (option)
(3) Signal output (QRS trigger, 1-channel ECG, remote alarm)
(4) USB connector for use with a memory stick to copy the stored data
(5) Fuses
(6) Mains connector
(7) Potential equalisation
(8) Connection for an external constant voltage source 11.5...48 VDC (e.g ambu-
lance)
(9) RS-232 interface for GSM or standard modem
(10) Ethernet connector for software updates
Art. no.: 0-48-0060 Rev.: a

V The plug-in connections are only designed for the connection of equipment or
accessories supplied by SCHILLER.

Page 15
2 Components and Operation
2.2 Operating Elements DEFIGARD 5000

2.2.3 Paddle Operation Elements

Keys for energy charging and release


of the defibrillation impulse

Energy selection key

Key for start and


stop of the recorder

Fig. 2.3 Paddles operation elements

2.2.4 LEDs
The LEDs give the following information:

(1) Operation with external constant voltage source


1 2 3 (2) Flashes while the battery is being recharged
(3) Unit connected to the mains

Fig. 2.4 Keys and LEDs


Art. no.: 0-48-0060 Rev.: a

Page 16
Components and Operation 2
DEFIGARD 5000 User Guide Operating Elements 2.2

2.2.5 Display
The display can vary according to the settings and used options. E.g. when 4 leads
are selected, the SpO2 waveform field is not displayed and only the measured values
to the right are visible.

Patient type - adult or neonate Battery charge status/mains supply


Synchronous pulse Remaining alarm suppression time or alarm
OFF
Date/time Display field for system and alarm messages Alarm delayed or off

System messages Function keys

ECG amplitude
ECG waveform
field
HR ECG 0.25/0.5/1/2 cm/mV

When more than


ECG leads
3 ECG curves
are displayed,
the SpO2 wave-
form field is re-
Volume QRS tone
moved.

ECG calibration
impulse 1 mV
Start recording

SpO2 waveform Start/stop NIBP


field measurement

Manual Paddle N
Synchro Confirmation or turn-
I ing off of alarms
B
P
Selected energy: 90 J
Start printer

Display field for defibrillator or pace- NIBP measuring field


maker mode
NIBP mode interval, manual or con-
tinuous
P
A DEMAND 80 P/min
C Alarm Type Indicators
E P 0 mA
Alarm active
Pacemaker message
Alarm delayed
Art. no.: 0-48-0060 Rev.: a

Alarm off with audible signal

Alarms permanently off

Fig. 2.5 Display elements of the DEFIGARD 5000

Page 17
3 Start-up and Initial Preparation
3.1 Mains and Battery Operation DEFIGARD 5000

3 Start-up and Initial Prepara-


tion
V Danger of electrical shock. Do not operate the unit if the earth connection is sus-
pect or if the mains lead is damaged or suspected of being damaged.
V Please read the safety notes in section 1 before initial operation.
V Danger of explosion! The device is not designed for use in areas where an ex-
plosion hazard may occur. Also, it is not permitted to operate the defibrillator in
an oxygen-enriched environment or in the presence of flammable substances
(gas) or anesthetics. Oxygenation in the vicinity of the defibrillation electrodes
must be strictly avoided.
V Danger of electrical shock. The DEFIGARD® 5000 is a high-voltage therapy de-
vice. Improper use of the device can endanger life. Always follow the instructions
given in this user guide.
V The user must make sure that there are no conductive connections between the
patient and other persons during ECG analysis and defibrillation.
V Avoid defibrillation in very moist or wet surroundings.

3.1 Mains and Battery Operation


3.1.1 Connecting the Unit to the Mains and Switching it on
1. Connect the mains cable to the rear of the unit (3) and to the mains
(100 V – 240 V). The mains voltage LED is lit and the battery charge LED
flashes.
2. If necessary, connect the potential equalisation cable (2) to the central potential
equalisation socket.
3. Press the on/off button.
4. Check the settings according to section Default and User-Defined Thresholds on
page 63.
5. Connect the other needed cables.

1 2 3

Fig. 3.1 Connections


Art. no.: 0-48-0060 Rev.: a

To prevent leakage current, the device must be connected to the room's central po-
tential equalisation via the potential equalisation socket.
A potential equalisation cable (article no. U50030) can be obtained from SCHILLER.

Page 18
Start-up and Initial Preparation 3
DEFIGARD 5000 User Guide Mains and Battery Operation 3.1

3.1.2 Battery Operation


Charging the Battery

Important
The internal battery is automatically recharged when the device is connected to the
mains (or an external constant voltage source). The battery requires approx. 1 hour
1 to be 80% recharged.
The recharging of the battery is indicated by the LED below the battery symbol.
– LED (1) flashes while the battery is being recharged.

Fig. 3.2 LED battery operation

Battery Low Indication


When the battery is low, a flashing battery symbol is displayed at the top of the
screen. The arrows show which of the batteries (upper or lower ) is low.
Fig. 3.3 Battery low indication

3.1.3 Operation with External Constant Voltage Source

The DEFIGARD® 5000 can be connected to an external 11.5...48 V constant voltage


source (e.g. vehicle battery) by a technician (see 1, Fig. 3.1). For this, the following
must be observed:
• The negative terminal of the ambulance power supply must be connected to chas-
sis.
• The connecting leads must have a minimum diameter of 1.5 mm2. All terminals and
plugs must be designed to withstand high currents.
• The positive lead must be protected with a 10 A fuse.
– The LED lights up when the device is powered from the external DC
source.
Art. no.: 0-48-0060 Rev.: a

Page 19
3 Start-up and Initial Preparation
3.2 Switching off and Disconnecting from Mains DEFIGARD 5000

3.2 Switching off and Disconnecting from Mains


1. Press the on/off button.
2. Select Yes using the configuration key (1).
3. Confirm the selection by pressing the configuration key.
4. Remove the mains cable Fig. 3.1 to disconnect the device from the mains if you
do not want to recharge the battery.

3.2.1 Internal Safety Discharge


The DEFIGARD® 5000 has an internal safety discharge circuit for internal dis-
charge of the stored energy. The defibrillator displays the message "Internal dis-
charge" during the safety discharge. The energy is internally discharged when

• the shock is not delivered within 20 s of charging


• a lead failure occurs
• a lower energy value is selected while the defibrillator is charging
• a shock is delivered into open air
• the battery voltage is insufficient
• the device is defective
• the device is turned off
Furthermore the residual energy stored in the defibrillator 100 ms after shock release
is always discharged internally.

3.2.2 Mains Supply Interruption

If the mains supply is interrupted, the device automatically switches over to battery
operation. The user settings are maintained. These settings can be saved.

3.2.3 Ensuring Operational Readiness

• Do not expose the device to direct sunlight, or extremely high or low temperatures.
The ambient temperature should be in the range of 0 °C...50 °C. Lower or higher
ambient temperatures will have a negative impact on the battery's life.
Art. no.: 0-48-0060 Rev.: a

To ensure its readiness for use, the device runs a self-test to check the unit and the
battery. The self-test is run:
• when the device is turned on
• automatically (the self-test intervals can be defined by the user in the settings).
If the device detects an error during the self-test, an error message is displayed.

Page 20
Start-up and Initial Preparation 3
DEFIGARD 5000 User Guide Inserting Printing Paper 3.3

3.3 Inserting Printing Paper


Important
The device is delivered without printing paper installed. Only use original SCHILLER
printing paper. The thermo-paper is sensitive to heat, humidity and chemical va-
pours. Store the paper in a cool and dry area.

1. Press the locking catch (1) upwards. The printer door opens downward.
2. Insert paper and pull it up. Be sure that the paper lies behind the cover (2).
3. Close the cover. Be sure that the paper lies exactly between the rails (3).

3
Art. no.: 0-48-0060 Rev.: a

Page 21
3 Start-up and Initial Preparation
3.4 Operation DEFIGARD 5000

3.4 Operation
The menus can be accessed in two ways:
• Direct access by pressing the navigation button
• By turning the navigation button to select the desired box and then pressing the
button to enter the menu

3.4.1 Direct Menu Access


1. Press the navigation button (1). When the button is pressed twice, the main menu
is directly opened and step 2 is dropped.
1 2. The main menu is opened by pressing the Menu softkey (2). The main menu is
displayed. (See Fig. 3.5)
3. To select, display or modify a menu, turn and press the button.
4. To exit a menu, press Enter .

Fig. 3.4 Turn and press the navigation


button

System messages
Menu
HR ECG

Edition

Main menu Sync

ECG Menu
Manual Paddle N
DIA NIBP Menu
Synchro
I
SpO2 Menu
B
Selected energy: 90 J P
Art. no.: 0-48-0060 Rev.: a

Fig. 3.5 Display with main menu

The threshold values can be changed either via the different menus or directly in the
threshold menu .
The time, volume and printer configuration can be set in the unit settings menu
.

Page 22
Start-up and Initial Preparation 3
DEFIGARD 5000 User Guide Operation 3.4

3.4.2 Accessing Menus and Function Keys via Display Fields


1. Select the desired display field using the navigation button (1). The selected dis-
play field (2) is shown with a different background colour and flashes. The
softkeys (3) change their functions depending on the selected field.
1
2. The selected menu (4) is displayed by pressing the navigation button.
3. To leave the menu, press the navigation button twice.

Fig. 3.6 Turn and press the navigation


button

2 3

System messages

HR ECG
ECG Menu

Number of curve(s) 3
Lead channel 1 I, II, III
Lead channel 2 DEFI
0.5
HR SpO2
QRS beep Medium
Speed 25 mm/s
Patient Adult
High threshold 130 Manual
Paddle
DIRECT
DIA
Low threshold 40

Exit

Fig. 3.7 Menu access via display field


Art. no.: 0-48-0060 Rev.: a

Page 23
4 Monitoring
4.1 Softkeys, Waveforms and Measurement Fields DEFIGARD 5000

4 Monitoring
The operation and menu access are detailed on page 22.

4.1 Softkeys, Waveforms and Measurement


Fields
The waveform and measurement fields are automatically displayed when the device
is switched on, whereas the ECG and SpO2 are only displayed when the correspond-
ing patient cable or sensor is connected.
The device can basically be operated via the softkeys on the right of the display. The
functions of these keys vary according to the selected waveform field.

System messages

HR ECG

Manual Paddle N
DIRECT
I
B
P
Selected energy: 90 J

Settings
The settings that are defined via the softkeys or menus remain saved when the unit
Art. no.: 0-48-0060 Rev.: a

is switched off and will automatically be active when it is switched on again.

Page 24
Monitoring 4
DEFIGARD 5000 User Guide Alarm Messages 4.2

4.2 Alarm Messages


Physiological Alarms
1 2
When a measurement reading exceeds an alarm limit, an alarm is triggered after
3 seconds and
• the measurement value field 3 flashes red
• an interrupted alarm sounds (4 beeps/s)
HR ECG • An error message is displayed on the top of the alarm field
Technical Alarms
3 When a technical error occurs:
• An error message is displayed on the top of the alarm field
• an interrupted alarm sounds (2 beeps/s)
• A question mark is displayed instead of the measurement reading (4)
• if a threshold value is exceeded, -?- is displayed.
Contrary to alarms due to violation of alarm limits, which must be acknowledged by
pressing a key (5) according to the settings, this alarm clears automatically as soon
as its cause is no longer present.
4
Suppressing an Alarm Sound
Suppress the alarm by pressing the button (5):
• If you press the button briefly, the alarm remains suppressed for 2 min and the sym-
bol (1) is replaced by the remaining time in minutes.
5 • If you keep the button pressed for approx. 3 s, it remains shut off until it is reacti-
vated by the same button. The ∞ symbol is displayed instead of the time (1) and a
beep sounds every 2 min.
The measurement reading will flash red until it returns to the normal range.

Activating the Alarm Sound


Fig. 4.1 Alarm indicators
To reactivate the alarm, press the button (5) again.

In some countries it is not permitted to disable audio alarms permanently.


Therefore, this function can be configured. (See page 68, section 10.3.1.)

Alarm Symbols (2)

Alarm active

Alarms suppressed for 2 minutes. This symbol is displayed when the alarm suppres-
Art. no.: 0-48-0060 Rev.: a

sion key (5) is pressed.

Threshold value alarms off (except min. HR and min. pulse SpO2). This symbol is dis-
played when the alarm suppression key (5) is pressed, but only if the alarm settings
are off. Technical alarms will still be issued.

Alarms permanently off. This symbol is displayed when the alarm suppression key
(5) is pressed for 3 s, but only if the alarm settings in the device settings menu are
permanently off.
(See page 68, section 10.3.1.)

Page 25
4 Monitoring
4.3 ECG and Heart Rate Monitoring DEFIGARD 5000

4.3 ECG and Heart Rate Monitoring


V False diagnosis . Only use silver/silver-chloride electrodes if the patient may
have to be defibrillated while the ECG is being displayed. Other electrodes may
create high polarisation voltages and the ECG trace on the monitor and on the
recording may simulate cardiac arrest.
V Danger of destroying the device during defibrillation! The device is only type CF
protected if the original SCHILLER patient cables are used.
V Patients with a pacemaker must be observed continuously because the heart
rate from the pacemaker might still be registered in case of a cardiac arrest or
some arrhythimas.

Important
The guidelines for patient electrode placement are provided as an overview only.
They are not a substitute for medical expertise.

4.3.1 Quick Diagnosis of the ECG Using Defibrillation Electrodes


For a quick diagnosis, the ECG signal can be recorded from the patient's thorax using
the defibrillation electrodes. In all other situations, we recommend acquiring the ECG
via ECG electrodes and the patient cable.
If no patient cable is connected, the ECG is automatically sensed with the defibrilla-
tion electrodes (lead designation "DEFI").

Fig. 4.2 Defibrillation electrodes

4.3.2 Connecting a 3-Lead ECG Patient Cable


ECGs acquired with a 3 or 4-lead patient cable are automatically displayed in chan-
nels 1 and 2, if no other parameter is activated.
Red Yellow

When a patient cable is connected and the adapter module for defibrillation elec-
Green trodes is inserted, you can select the signal source in the ECG menu.
Art. no.: 0-48-0060 Rev.: a

Fig. 4.3 3-lead cable

Page 26
Monitoring 4
DEFIGARD 5000 User Guide ECG and Heart Rate Monitoring 4.3

4.3.3 Connecting a 4- or 10-Lead ECG Patient Cable


ECGs acquired with the 10-lead cable are displayed in all three channels, if no other
parameter is activated.
Red Yellow

White

When a patient cable is connected and the adapter for defibrillation electrodes is in-
white to C1...C6 serted, you can select the signal source in the ECG menu.

Green
Black

Fig. 4.4 4- and 10-lead cable


Art. no.: 0-48-0060 Rev.: a

Page 27
4 Monitoring
4.3 ECG and Heart Rate Monitoring DEFIGARD 5000

4.3.4 Starting ECG Monitoring

Amplitude
1. Apply the electrodes as shown in Fig. 4.3 or Fig. 4.4.
0.25, 0.5, 1, 2 cm/mV 2. Connect the patient cable to the ECG signal input.
3. Define the ECG settings directly via the softkeys.
Display of amplitudes 4. Open the ECG menu and check the settings.
I...V6

Fig. 4.5 ECG softkeys

4.3.5 Monitoring a Pacemaker Patient

V Erroneous HR readout. In the monitoring of pacemaker patients, we cannot ex-


clude the possibility of pacer pulses being counted as QRS complexes. There-
fore, pacemaker patients should always be watched closely. We recommend
monitoring pacemaker patients by means of the plethysmogram ( HR
source = SpO2 in the ECG or SpO2 menu).

When monitoring the heart rate of pacemaker patients, it is important that the device
will only count the QRS complexes and reject the pacer pulses.
The DEFIGARD® 5000 has an electronic pacer pulse suppression algorithm which
rejects the pacer pulses so they are not counted as QRS complexes. Depending on
the pacemaker model used and on the position of the electrodes, the compensation
pulse following every pacer pulse may be considered as a QRS complex. In this sit-
uation and when the pacer pulse is ineffective, the displayed heart rate may lead to
a misinterpretation, and the device will not give alarm in the case of bradycardia or
asystole. It depends on the pacer pulse parameters whether or not the compensation
pulse is counted as a QRS complex.
For pacemaker patients, the ECG signal amplitude should be greater than 1 mV.

If the source of the heart rate is SpO2, this is indicated by the HR <- SpO2 symbol and
a flashing S.

Art. no.: 0-48-0060 Rev.: a

Fig. 4.6 Indication HR source SpO2

Page 28
Monitoring 4
DEFIGARD 5000 User Guide ECG and Heart Rate Monitoring 4.3

4.3.6 ECG Menu


Menu Parameter Description Value
ECG a
Number of curve(s) Number of the curves displayed. When the 0 / 1 / 2 / 3 / 6 /12
number is 6, SpO2 is not displayed.
Lead channel 1 Preselection of the standard waveform Defi/I, II, III/aVR, aVL, AVF/V1,V2,V3/
groups that should be displayed. V4, V5, V6
Lead channel 2 Preselection of the standard waveform bDefi/I, II, III/aVR, aVL, AVF/V1, V2,
groups that should be displayed. V3/V4, V5, V6
ECG amplitude setting. 0.25 / 0.5 / 1 / 2 cm/mV

c
Source based on which the heart rate HR ECG/HR SpO2
should be determined.
QRS sound Volume of the systolic sound Off/Low/Medium/High
Speed Speed of the ECG curve display 25/50 mm/s
Patient Selection of patient type Adult/Neonate
d
High threshold High heart rate threshold 140...300/Off
c
Low threshold Lower heart rate threshold Off/60 (range 30...125)

a. The number of displayed ECG curves and selectable leads is determined by the type of the patient cable connected.
b. The "Defi" option is only available when a patient cable and an adapter module with defibrillation electrodes are connected.
c. When the patient has a cardiac pacemaker, the HR source must be set to SpO2 (see page 28).
d. The threshold values are only displayed after the user's threshold values have been opened once in the threshold values menu.
(See page 63, section 9.)

4.3.7 ECG Error Messages


Alarm Cause Remedy
CONNECT THE ELEC- • Electrodes not attached to the pa- « Check the contact between the electrodes and the pa-
TRODES! tient; come off; bad contact tient's body
• Electrodes defective; line break « Check the ECG cable and electrodes
• Device defective « Have the device repaired
FIBRILLATION • Ventricular fibrillation or tachycar- « Physiological alarm!
dia with a rate exceeding 180 p/
min
Art. no.: 0-48-0060 Rev.: a

Page 29
4 Monitoring
4.4 SPO2 Monitoring DEFIGARD 5000

4.4 SPO Monitoring


2

• The pulsoximeter enables the continuous non-invasive monitoring of the functional


oxygen saturation of the arterial haemoglobin and the pulse rate. When the signal
is received from the patient sensor, this signal is used to calculate the patient's
functional oxygen saturation and pulse rate.
• The display shows the continuous progress of the numeric SpO2, pulse rate,
plethysmographic waveform and signal quality values.
• The displayed plethysmographic curve is not proportional to the pulse volume.
• The update period of the measurement readings on the display is 0.2 seconds.
• According to the relevant standards, the temporary alarm suppression must be set
to a maximum of 2 minutes.

V Only use sensors listed in the order information for SpO2 measurement with the
DEFIGARD® 5000. Other oxygen transducers (sensors) may lead to improper
performance.
V The information in this user guide does not overrule the instructions given in the
user guide of the sensor, which must also be observed.
V Never use a pulsoximeter during MR imaging. Induced current could potentially
cause burns, and the pulsoximetry may affect the image and the accuracy of the
measurements.
V Before using the sensor, carefully read the sensor directions for use.
V Tissue damage can be caused by incorrect application or use of a sensor. In-
spect the sensor site as described in the sensor directions for use to ensure skin
integrity and correct positioning and adhesion of the sensor.
V Do not use damaged patient cables, damaged sensors or a sensor with exposed
optical components.
V Substances causing disturbances: Carboxyhaemoglobin can lead to falsely high
measurement readings. The degree of the deviation approximately corresponds
to the quantity of carboxyhaemoglobin. Colours or substances containing col-
ours that influence the natural blood pigments can also lead to incorrect meas-
urement readings.
V Exposure to excessive illumination, such as surgical lamps (especially those
with xenon light source), bilirubin lamps, fluorescent lights, infrared heating
lamps or direct sunlight, can affect the performance of an SpO2 sensor. To pre-
vent exposure to excessive illumination, ensure that the sensor is correctly ap-
plied and that it is covered with an opaque material, if required. If these meas-
ures are neglected, excessive illumination can lead to incorrect measurements.
V Change the position of the sensor at least every 4 hours, and every 2 hours if
the perfusion is low.

4.4.1 Starting SpO2 Monitoring and Test


Art. no.: 0-48-0060 Rev.: a

3 1. Apply the SpO2 sensor to the patient. Insert the patient's forefinger into the probe
as far as it will go, and make sure that the finger tip covers all of the probe window.
This is to prevent that extraneous light reaches the photodetector.
2. Activate the module by connecting the SpO2 sensor to the device.
3. Set the lower SpO2 alarm limit to 99%.
4. When the measured value exceeds the alarm limit, an alarm is issued.
5. Reset the alarm limit to its original value.
1 2

Fig. 4.7 SpO2 measurement field

Page 30
Monitoring 4
DEFIGARD 5000 User Guide SPO2 Monitoring 4.4

4.4.2 SpO2 Menu


Menu Parameter Description Value
SpO2 SpO2 curve Display of the SpO2 curve Yes/no
(1) Average Definition of the integration time for the cal- 8/16 seconds
culation of the displayed average value
aSource based on which the heart rate HR ECG/HR SpO2
should be determined
Speed Speed of the SpO2 curve display 25/50 mm/s
Patient Selection of patient type Adult/Neonate
High pulse threshold High pulse alarm limit (130...250)/Off
Low pulse threshold Low pulse alarm limit Off/50 (range 30...125)
(3) bHigh SpO2 threshold High oxygen alarm limit 100/Off (range 55...250)

(2) bLow SpO2 threshold Low oxygen alarm limit Off/85 (range 50...99)

a. When the patient has a cardiac pacemaker, the HR source must be set to SpO2 (see page 28).
b. The threshold values are only displayed after the user's threshold values have been opened once in the threshold values
menu. (See page 63, section 9.)

4.4.3 SpO2 Error Messages


Alarm Cause Remedy
Low perfusion • Weak pulse « Check/reapply the sensor
• Bad sensor positioning
TOO MUCH LIGHT! • Sensor is disturbed by ambient light « Reduce ambient light
CAPTOR PROBLEM! • Sensor failed « Replace the sensor
ARTEFACTS! • Measurement disturbed by external influ- « Patient must not move
ences
SENSOR OFF PATIENT! • Sensor not connected to the patient or « Check the contact between the sensor and the
lose patient
SEARCH PULSE! • Device is searching for the pulse « Make sure that the sensor is well connected to
the patient
CAPTOR PROBLEM! • Wrong or defective sensor « Replace the sensor
NO CAPTOR! • SpO2 sensor failed or disconnected « Replace the sensor
Art. no.: 0-48-0060 Rev.: a

Page 31
4 Monitoring
4.5 NIBP Monitoring DEFIGARD 5000

4.5 NIBP Monitoring


The non invasive blood pressure is measured by the oscillometric method. The cri-
teria for this method are the pressure pulsations superimposed, with every systole,
on the air pressure in the cuff, rather than the associated sounds (there is no micro-
phone in the cuff).
The module performs single measurements and automatic measurements at se-
lectable intervals.
During blood pressure measurements the cuff must be on a level with the heart. If
this is not ensured, the hydrostatic pressure of the liquid column in the blood vessels
will lead to incorrect results. When the patient is sitting, standing or supine during
measurements, the cuff is automatically at the correct level.
The blood pressure can be measured in mmHg or in kPa.

V To prevent extensive pressure on the extremity, it is very important to choose


the correct cuff size and to check the setting in the panel System/Patient (Adult,
Pediatric, Neonatal).
V In case of long-term monitoring or automatic operation, the connected body ar-
eas of the patient and the extremity to which the cuff is attached must be
checked regularly for signs of ischaemia, purpura and/or neuropathy.
V The cuff must not be attached to a limb that is already used for interventions
such as infusions.
V To prevent incorrect measurement results, make sure that the tube is not com-
pressed.

To prevent erroneous SpO2 measurements, the blood pressure cuff should not be
positioned on the limb on which the SpO2 is measured.

Art. no.: 0-48-0060 Rev.: a

Page 32
Monitoring 4
DEFIGARD 5000 User Guide NIBP Monitoring 4.5

4.5.1 Starting NIBP Monitoring


1. Note the cuff size for the respective patient type.
2. The cuff is attached to the left or right upper arm. About 4 cm above the elbow (on
children and infants a little closer).
Patient Patient type
3. Connect the cuff tubing to the connection sleeve and make sure it properly locks
into place.
Cycle times or manual 4. Define the NIBP settings directly via the softkeys.
measurement – Patient type – adult or neonate. (Indicated at the top right.)
– Setting of the cycle time or manual measurement
– Start of the NIBP measurement

Start of NIBP meas- 5. Open the NIBP menu and check the settings.
urement 6. Start the NIBP measurement by pressing the softkey.
7. To disconnect the cuff tube, press the milled shell of the connecting sleeve back-
wards.
Fig. 4.8 NIBP softkey

Display of the cycle time or The following settings are available for the cycle time:
manual measurement
3/3 min Time remaining until the next measurement/cycle time
Manual The measurement is manually initiated by pressing the softkey.
Continuous A measurement is taken every 10 seconds for a certain period
N of time. The period can be set in the range of 5...15 min.
I
B
P

The NIBP measurement must be initiated via the NIBP start softkey, regardless of
this setting.

When the measurement is started, the measurement readings are replaced by the
Fig. 4.9 NIBP measuring field cuff pressure and the number of attempts.
Art. no.: 0-48-0060 Rev.: a

Page 33
4 Monitoring
4.5 NIBP Monitoring DEFIGARD 5000

4.5.2 NIBP Menu


Menu Parameter Description Value
NIBP Cycle time setting Manual, Continuous or cycle of 1/2/3/
5/10/15/20/30/40/90 minutes

Patient Selection of patient type Adult/Neonate


Unit Unit setting of mmHg or kPa mmHg / kPa
Calibration Calibration of the NIBP module This function requires a password from
the service department
a
High SYS threshold High systolic alarm limit 180 (70...250)
aLow SYS threshold Low systolic alarm limit 70 (Off/50...225)
a
High MAP threshold High alarm limit for average pressure 160 (25...250)
a
Low MAP threshold Low average limit for average pressure 50 (Off/20...245)
a
High DIA threshold High diastolic alarm limit 110 (15...200)
aLow DIA threshold Low diastolic alarm limit 40 (Off/10...195)

a. The threshold values are only displayed after the threshold menu has been opened once. (See section 9, page 63.)

4.5.3 NIBP Error Messages


Alarm Cause Remedy
NIBP error • NIBP module failed « Replace the device
Zero pressure • No pressure can be measured « Check cuff and connection
• Device defective « Replace the device
Low pressure • Pressure below limits « Check cuff and connection
Insufficient pressure • Pressure in the cuff remains too « Check cuff and connection for leaks
low
Bad cuff • Pressure too high because « Check cuff and connection
- Too small cuff applied
- Tube buckled
Measure too long • Measurement time exceeded with « Check cuff and connection
no results « Make sure that the cuff is well applied
ARTEFACTS! • Measurement disturbed by exter- « The patient must not move during measurement
nal influences
Low pulse • Pulse amplitude too low « Apply cuff correctly
Measure too old • Last measurement more than « None (just for information); if required, start a new meas-
15 minutes ago urement
Art. no.: 0-48-0060 Rev.: a

Pump >20 s • Pumping running time exceeded « Check cuff and connection for leaks

Page 34
Monitoring 4
DEFIGARD 5000 User Guide Trend Display 4.6

4.6 Trend Display


The trends present the vital signs collected over a period of time in an easy to read
format. You can choose between the graphic format (trend curve) and the tabular for-
mat.

4.6.1 Displaying Trends

1. Press the navigation button.


2. Press the Edition softkey.
3. Press the trend key (1).
1 4. Press trend curve (2) or trend table (3) key.
5. Configure the desired curves or table values in the respective menu and confirm
your settings with OK. The table or curve is displayed.
2

Fig. 4.10 Accessing the trend displays

Curve Settings

HR P/min Yes
SpO2 % Yes Up to two curves can be displayed.
NIBP mmHg NO 1. Select the curve combination with Yes.
OK 2. Confirm your settings with OK. The trend display is opened.

Fig. 4.11 Curve settings

Table Settings

HR P/min Yes
When "NIBP Measure" is selected for the "Period" parameter, the selected values are
Art. no.: 0-48-0060 Rev.: a

SpO2 % Yes
recorded for every NIBP measurement.
NIBP mmHg NO 1. Select the required table values with Yes.
Period 2 min 2. Select the desired recording period.
3. Confirm with OK. The trend display is opened.
OK

Fig. 4.12 Table settings

Page 35
4 Monitoring
4.6 Trend Display DEFIGARD 5000

Trend Display for HR/SpO2 Curves

Moving forward and back-


ward by one page
Exit

Change of the time axis in the Change of the vertical


range of 1 to 24 hours scale

Trend Table

HR SpO2 NIBP
Time p/min % mmHg
14:00 75 98 120 / 75
14:02 75 98 /
14:04 75 98 /
14:06 75 98 /
14:08 75 98 /
14:10 75 98 120 / 75
14:12 75 98 /
14:14 75 98 /
14:16 75 98 /
14:18 75 98 /
Art. no.: 0-48-0060 Rev.: a

14:20 75 98 120 / 75
14:22 75 98 /
14:24 75 98 /
14:26 75 98 /

Exit
To the begin-
ning of the ta-
ble
Table printout
Forward or backward To the end of
the table

Page 36
Monitoring 4
DEFIGARD 5000 User Guide Trend Display 4.6

4.6.2 Deleting the Trend Memory


1. Press the navigation button.
2. Press the function key Edition.
3. Press the trend function key (1).
4. Press the delete function key (3).
1
5. Confirm with or cancel with .

2
3

Fig. 4.13 Deleting trend data

4.6.3 Transmitting the Event Memory

1. Press the navigation button.


2. Press the function key Edition.
3. Press the memory function key (1).
4. Transmit the data by pressing the transmission function key (2).

5. To cancel the transmission, press .

2
1

Fig. 4.14 Transmitting trend data


Art. no.: 0-48-0060 Rev.: a

Page 37
5 Defibrillation
5.1 Rules and Safety Notes DEFIGARD 5000

5 Defibrillation
5.1 Rules and Safety Notes
Observe the following guidelines to ensure successful and safe defibrillation. Other-
wise the lives of the patient, the user and bystanders are in danger.

V The patient must:


– not come into contact with other persons during defibrillation.
– not come into contact with metal parts, e.g. bed or litter, or be positioned on wet
ground (rain, accident in swimming pool), to prevent unwanted pathways for the
defibrillation current, which may endanger the assistants.
V Do not allow the defibrillation electrodes to come into contact with other elec-
trodes or metal parts which are in contact with the patient.
V The patient's chest must be dry, as moisture causes unwanted pathways for the
defibrillation current. For safety, wipe off flammable skin cleansing agents.
V Owing to the high currents, there is a risk of skin burns at the site of the elec-
trodes. This is why the electrodes must not be placed on or above:
– the sternum, clavicle or mamillas
V Immediately prior to the shock, the heart massage (CPR) and artificial respira-
tion must be stopped and bystanders must be warned.
V Defibrillating a patient with an implanted pacemaker is likely to impair the pace-
maker function or cause damage to the pacemaker. For this reason, do not apply
the defibrillation electrodes in the vicinity of the pacemaker, have an external
pacemaker at hand, and check the implanted pacemaker for proper functioning
as soon as possible after the shock.

V Equipment damage! Sensors and devices that are not defibrillation proof must
be disconnected from the patient before a shock is triggered.

Art. no.: 0-48-0060 Rev.: a

Page 38
Defibrillation 5
DEFIGARD 5000 User Guide Rules and Safety Notes 5.1

5.1.1 Additional Safety Notes for SAED Mode


In addition to the guidelines set forth in section 5.1, the following rules must be ob-
served when using an SAED, as failure to do so may compromise the success of the
defibrillation or endanger the patient's life.

V The user is committed to verify the prerequisites for the use of the SAED by
checking for lack of consciousness, lack of breathing and lack of circulatory
signs using the ABCD system (BLS algorithm).
V The device must only be used if the following symptoms are found:
– non-responsive
– no respiration
– no pulse
V If, in the course of treatment, a patient spontaneously regains consciousness, a
defibrillation shock that may have been advised just before must not be deliv-
ered.
V To ensure correct analysis of the heart rhythm, the patient must lie as still as pos-
sible and must not be touched, as this can lead to incorrect analysis results due
to artefacts.
V If, in SAED mode, the ECG signal changes such that the shock is not recom-
mended, the shock delivery is automatically blocked.

5.1.2 Defibrillating Children

V Please note that less energy is needed for children.


For the first defibrillation of infants and small children using biphasic shock, ap-
prox. 1 joule/kg body weight is released. An increase to 2 joules/kg body weight
is possible when the defibrillation is repeated.
V For the defibrillation of children, the pediatric clip-on electrodes must be at-
tached to the paddles or pediatric pads must be used.
Art. no.: 0-48-0060 Rev.: a

Page 39
5 Defibrillation
5.2 General Function DEFIGARD 5000

5.2 General Function


• The DEFIGARD® 5000 works with biphasic pulsed defibrillation impulse. De-
pending on the factory settings, the device either switches automatically from syn-
chronized to non-synchronized defibrillation or the mode has to be changed man-
ually using the Sync button.
• The required energy for a successful defibrillation depends on the patient's age,
thickness of the tissue and constitution. For emergency medical treatment, AHA/
ERC recommend (biphasic impulse):
– 1st shock with 90 joules; if unsuccessful
– 2nd shock with 130 joules; if unsuccessful
– 3rd shock with 180 joules
• When a patient cable is connected, you can select in the ECG menu if the ECG
should be recorded via the separate ECG electrodes or the defibrillation elec-
trodes. You can select a higher energy value while the defibrillator is charging. The
device will charge to the new level. It is not possible, however, to reduce the
charged energy. In this case, the stored energy will be discharged internally and
you will have to recharge the defibrillator.

5.2.1 Activating the Manual or Automatic Defibrillation Mode


When the device is switched on, it selects the defibrillation mode based on the con-
nected electrodes.
• Paddles = manual defibrillation
• Spoons = manual defibrillation
• Adhesive electrodes = manual or automatic defibrillation (configurable)
You can switch from automatic to manual defibrillation by pressing the relevant
softkey.

5.2.2 Manual Defibrillation - Procedure

Manual
1. Charge of the required energy with
Paddle
DIRECT
– paddles via the energy selection switch and the red charging/release button
– adhesive electrode or spoon via keyboard
Selected energy: 90 J 2. Release of the shock with
– paddles via both red charging/release buttons
– adhesive electrode and spoon via shock button on the device

More energy

Less energy
Art. no.: 0-48-0060 Rev.: a

Charge

Fig. 5.1 Defibrillator window

Page 40
Defibrillation 5
DEFIGARD 5000 User Guide Manual Defibrillation Using Paddles 5.3

5.3 Manual Defibrillation Using Paddles


V Delivering a shock to a patient normal heart rhythm may induce ventricular fibril-
lation. For this reason, first read the general rules and safety information in sec-
tion 5.1.
V Electric shock hazard! Turn off the device before exchanging the defibrillation
electrodes; exchanging the electrodes on a charged defibrillator initiates an in-
ternal safety discharge.

• The defibrillation shock can be triggered only when the electrodes are applied to
the patient and the skin resistance does not exceed a certain level. Otherwise the
energy will be discharged internally when the shock is released!
• When the shock is not delivered within 20 s of charging, it will be discharged inter-
nally.

1. Remove the paddles from their compartments.


2. Carefully dry the paddles and the handles in particular, if they are wet.
3. Apply an ample amount of electrode cream to the paddle surfaces.
4. Apply the paddles as shown in Fig. 5.2:
STERNUM: right sternal edge at the level of the 2nd intercostal space
APEX: left axillary line at the level of the 5th intercostal space
5. Select the required energy via the energy selection button.
6. Initiate charging by pushing one of the red buttons on the paddles. The bar dia-
gram shows the energy charging process.
7. Do not touch the patient any more and warn all those present.
8. As soon as the charging process is completed,
– a beep sounds
Keys for energy charging and release – the message "Defibrillator ready" is displayed
of the defibrillation impulse – the two shock keys on the paddles light up
9. Press the paddles firmly down onto the thorax.
10. Simultaneously press both buttons on the paddles.
Energy se-
After delivery of the shock, the audio signal stops and the recorder starts (if con-
lection key
figured). The recording can be stopped at any time by pressing the green button
on the paddle or the button on the device (see "recording" section).
11. Monitor the patient's ECG.
12. When no further shocks are required, switch the energy selection button back to
"0" and turn the device off.
13. Finish the therapy. (See page 60.)

Fig. 5.2 Paddle application

5.3.1 Marking Events


Art. no.: 0-48-0060 Rev.: a

Each time you push the event button, the menu with your event texts will appear. You
can select one of these texts with the softkey and this text will be recorded in the data
report with the time of day.
The key texts are configurable.

Fig. 5.3 Event button

Page 41
5 Defibrillation
5.4 Manual Defibrillation Using Pads DEFIGARD 5000

5.4 Manual Defibrillation Using Pads


V Delivering a shock to a patient with normal heart rhythm may induce ventricular
fibrillation. For this reason, first read the general rules and safety information in
sections 5.1 and 5.2.
V Electric shock hazard! Turn off the device before exchanging the defibrillation
electrodes; exchanging the electrodes on a charged defibrillator initiates an in-
ternal safety discharge.

5.4.1 Applying the Pads

V Only use the pads up to their expiration date. Please note that the indicated ex-
piration date only applies if the vacuum pack is intact.
V The pads are pre-gelled, so there is no need to use extra contact agent.
V Do not reuse the pads.

Adult and Pediatric Electrodes

Large electrodes The large electrodes are intended for adults and children from a body weight of
25 kg.

Small electrodes The small electrodes are intended for children with a body weight under 25 kg.
Applying the Electrodes

V Good contact between the skin and the adhesive electrodes must be ensured.
Suntan oil, sand or salt reduce the adhesive quality.
V The applied pads must have good contact with the patient's skin, and air bubbles
under the pads must be avoided. To do so, stick on one end of the pad, then
smooth it out to the other end.

1. Clean and dry the application points for the electrodes (Fig. 5.4). Shave if the pa-
tient's chest is hairy. Only clean the skin by vigorously rubbing it with a dry cloth.
2. Apply one electrode above the right nipple. Do not apply it on the clavicle (une-
ven).
STERNUM: right sternal edge at the level of the 2nd intercostal space
3. Apply the other electrode slantwise below the left breast as illustrated in Fig. 5.4.
APEX: left axillary line at the level of the 5th intercostal space
4. Make sure that the connections are positioned on the outside so they do not
hinder heart massage (CPR).
Art. no.: 0-48-0060 Rev.: a

Fig. 5.4 Electrode application points

Page 42
Defibrillation 5
DEFIGARD 5000 User Guide Manual Defibrillation Using Pads 5.4

5.4.2 Checking the Electrodes


If the resistance between the skin and an electrode is too high, the message CON-
NECT THE ELECTRODES is issued. Proceed as follows:
1. Alternately press the electrodes/pads down firmly and check when the message
disappears. Carefully press that pad onto the patient's skin once again.
If the message does not disappear,
2. remove both defibrillation electrodes
3. wipe rests of contact agent off with a cloth
4. shave the two application points to remove the epidermal skin layer
5. apply new defibrillation pads to these points
Art. no.: 0-48-0060 Rev.: a

Page 43
5 Defibrillation
5.4 Manual Defibrillation Using Pads DEFIGARD 5000

5.4.3 Manual Defibrillation Using Pads - Procedure


1. Connect the electrode cable to the adapter.
2. When the device is started in SAED mode, switch to manual mode by pressing

the softkey. A safety discharge is first carried out and the energy is set to
130 J.

3. Select the energy via the softkeys.


Adult Pads
DIRECT 4. Initiate the energy charging by pressing "Charge".

Selected energy: 130 J

V Danger of electric shock!


• Do not, under any circumstances, touch the patient during shock delivery.
• Make sure that the patient does not touch any conducting objects.
More energy
5. Trigger the shock by pressing the button .

Less energy

Charge

Fig. 5.5 Manual defibrillation using pads

Art. no.: 0-48-0060 Rev.: a

Page 44
Defibrillation 5
DEFIGARD 5000 User Guide Internal Defibrillation 5.5

5.5 Internal Defibrillation


V Patient hazard! Use only sterilised electrodes for internal defibrillation. Sterilise
internal electrodes before each use (see section 10 "Maintenance").

Spoon-shaped electrodes whose contours must match the dimensions of the heart
are used for internal defibrillation. The electrode surface must make full contact with
the heart. Internal electrodes are available in four different sizes (see order informa-
tion in section 12). As the electrodes are in direct contact with the heart, less energy
is required than for external (transthoracic) application. Therefore, the defibrillator
does not accept energy settings above 30 joules. The following energy levels are
available: 2, 4, 6, 8, 15, 30 joules.

1. Connect the spoons' electrode cable to the adapter.


2. Position the spoons on the heart.

3. Select the energy using the +/- J keys.


Manual Spoons
DIRECT 4. Initiate the energy charging by pressing "Charge".

Selected energy: 15 J

V Danger of electric shock!


• Do not, under any circumstances, touch the patient during shock delivery.
• Make sure that the patient does not touch any conducting objects.
More energy
5. Trigger the shock by pressing the button .

Less energy
Art. no.: 0-48-0060 Rev.: a

Charge

Fig. 5.6 Defibrillator window

Page 45
5 Defibrillation
5.6 Synchronised Defibrillation DEFIGARD 5000

5.6 Synchronised Defibrillation


V Erroneous triggering, interpretation hazard.
– For synchronised defibrillation, the ECG electrodes should be applied as far
from the defibrillation electrodes as possible (e.g. on the limbs).
– Use only silver/silver-chloride electrodes, if you acquire the ECG via separate
ECG electrodes. These electrodes prevent polarisation voltages which may be
caused by the defibrillation shock, resulting in an ECG trace on the monitor
screen or recording that simulates cardiac arrest.

V Disturbed ECG trigger! Signal Signal noise may disturb the ECG signal and
cause artefacts. This must be considered chiefly in the synchronised mode and
in demand pacing. For this reason, the following should be observed:
– Do not touch the device during defibrillation to prevent electrostatic noise
– Keep the patient cable away from power cords, transformers etc.
V To achieve adequate ECG signal quality for reliable triggering, ensure that
– the ECG signal is free of artefact
– there are no major fluctuations in amplitude
– the displayed trigger pulses are positioned exactly over the R-wave

5.6.1 Switching to Synchronised Defibrillation

The mode can be changed manually or automatically.

1. Go to the defibrillator window using the navigation key.


2. Press the key. The Sync key appears.
Sync 3. Using the Sync key, select synchronised or direct defibrillation. The setting Syn-
chro (1) or Direct is displayed in the defibrillator window.

1
Manual
Paddles
Synchro

Selected energy: 90 J

Fig. 5.7 Switching to/display of synchro-


nised defibrillation
Art. no.: 0-48-0060 Rev.: a

Page 46
Defibrillation 5
DEFIGARD 5000 User Guide Synchronised Defibrillation 5.6

5.6.2 Synchronised Defibrillation – Procedure

For synchronised defibrillation, the defibrillation shock is delivered in synchronisation


with the heart action, as the heart is still working. As a prerequisite, the patient's ECG
signal must be supplied to the defibrillator. After the physician has triggered the de-
fibrillation shock, the trigger signal for the actual shock delivery will be derived from
the subsequent QRS complex (25 ms after the trigger mark on the monitor screen
(1)).
The defibrillation mode can be switched automatically or manually between unsyn-
chronised and synchronised, depending on the factory settings (this setting can be
found in the Defibrillator menu - see page 66, section 9.1.5).

2 When the switchover is automatic, the DEFIGARD® 5000 switches to the synchro-
1
nised mode when it detects a QRS complex. If no QRS complex is detected for more
Manual
Paddles
than 3 seconds, the message SYNCRO (2) is replaced by SYNCHRO END and an au-
Synchro
dible signal sounds. After 3 more seconds, it switches from SYNCHRO (2) to DIRECT
defibrillation.
Selected energy: 90 J With devices set to manual switch, the mode is changed using the key. However, if
the device does not detect a QRS complex in the synchronised mode, the shock will
be delivered directly after 6 seconds. We recommend performing synchronised de-
fibrillation with pads and at the same time acquiring the ECG signal via the pads. As
Fig. 5.8 Synchronised defibrillation an alternative, the ECG can be acquired with ECG electrodes. You select the signal
source with the source button in the ECG menu.

Synchronised defibrillation using When using paddles for synchronised defibrillation, you can configure if the ECG
paddles must be recorded via separate ECG electrodes (Synchro using paddle - No) or if
the recording can be done using either separate ECG electrodes or the paddles
(Synchro using paddle - Yes). Defibrillation with pads is described on page 42; de-
fibrillation with paddles on page 41, and the application of ECG electrodes on page
42. Check that with each QRS complex
• the QRS beep sounds
• the trigger marks (1 - Fig. 5.8) and the "QRS blip" appear
Be aware that after initiation of the shock the actual shock will be released with the
next trigger signal derived from the ECG.
Art. no.: 0-48-0060 Rev.: a

Page 47
5 Defibrillation
5.7 Semiautomatic Defibrillation DEFIGARD 5000

5.7 Semiautomatic Defibrillation


V Delivering a shock to a patient normal heart rhythm may induce ventricular fibril-
lation. For this reason, first read the general rules and safety information in sec-
tions 5.1 and page 5.1.139.
V Electric shock hazard! Turn off the device before exchanging the defibrillation
electrodes; exchanging the electrodes on a charged defibrillator initiates an in-
ternal safety discharge.
V Do not use the anterior-posterior electrode placement for semiautomatic defibril-
lation.
V If, in the course of treatment, a patient spontaneously regains consciousness, a
defibrillation shock that may have been advised just before must not be deliv-
ered.
V During HF surgical interventions, ECG analysis is not permitted in the semiauto-
matic mode.

5.7.1 Semiautomatic Defibrillation (SAED) – Procedure


The user is guided through all operation steps by spoken and displayed instructions.

Automatic Pads Adult The SAED mode is automatically activated when the adapter for adhesive electrodes
DIRECT is inserted. (See page 66, section 9.1.5.)
After start-up, the user is prompted by a flashing symbol to connect the pads. When
the analysis key is pressed, there is a spoken message that the electrodes should be
connected to the patient, if this has not been done yet. After this, the user is advised
to stay clear of the patient. The analysis takes approximately 10 seconds.

Device detects a shockable rhythm If the analysis program detects a shockable rhythm, the defibrillation energy is
charged and the user is prompted to deliver the shock. Shockable rhythms are:
• Ventricular fibrillation
• Ventricular tachycardia with a rate exceeding 180 p/min
Even if the device detects a shockable rhythm, a shock must only be delivered if lack
of breathing and lack of circulatory signs have been established.
If the shock is not successful, the device automatically charges the defibrillation en-
ergy for a second or a third shock.

The following standard energy levels are preset:

Shock Adults Neonates


1 130 joules 15 joules
Art. no.: 0-48-0060 Rev.: a

2 130 joules 30 joules


3 150 joules 50 joules

The SCHILLER after-sales service can adjust different energy settings.

Page 48
Defibrillation 5
DEFIGARD 5000 User Guide Semiautomatic Defibrillation 5.7

Shock unsuccessful If also the 3rd shock is unsuccessful, the device prompts the user to:
• carry out alternately artificial respiration and heart massage.
• start a new ECG analysis after one minute. Depending of the configuration, this
new analysis can be started automatically.

Shock successful After a successful shock, the device prompts the user to:
• check the patient's respiration and circulation and
– if no signs of circulation are present, to alternately carry out artificial respiration
and heart massage
– if signs of circulation are present, to move the patient to the lateral position

Device detects no shockable rhythm If the analysis program does not detect a shockable rhythm, the device informs the
user about the further steps:
• informs that no shock is required
• prompts the user to check the patient's respiration and circulation
– if no signs of circulation are present, to alternately carry out artificial respiration
and heart massage
– if signs of circulation are present, to move the patient to the lateral position
– after one minute, prompts the user again to start a new ECG analysis. Depend-
ing on the configuration, this new analysis can be started automatically.
Art. no.: 0-48-0060 Rev.: a

Page 49
5 Defibrillation
5.7 Semiautomatic Defibrillation DEFIGARD 5000

Voice Support in SAED Mode


When the device is switched on, it carries out a self-test and indicates the software
and hardware version. The following instructions will be spoken by the device:

Language Display Note


Stick electrodes on bare and dry chest CONNECT THE ELEC- Technical alarm:
TRODES! Electrodes not yet applied. The message disap-
pears as soon as the electrodes are correctly ap-
plied and the resistance is below 250 Ohm.
Poor connection; press the electrodes PRESS THE ELECTRODES Technical alarm:
The contact between the electrodes and the skin
is not sufficient. The patient resistance is in the
range of 250 to 400 Ohm.
Press the green button PRESS THE GREEN BUT- Heart rhythm analysis is started.
TON
Do not touch the patient. Analysis in DO NOT TOUCH THE PA-
progress. TIENT
ANALYSIS IN PROGRESS
Motion detected; stop the motion MOTION DETECTED Technical alarm:
STOP MOTION The patient was moved during the analysis and
the device could not carry out the analysis.
Device recommends a shock
DO NOT TOUCH THE PA-
Do not touch the patient, charging TIENT, CHARGING IN
PROGRESS

Stand clear of patient, press orange but- PRESS ORANGE BUTTON


ton TO SHOCK
Device does not recommend a shock
Shock not recommended
Check for signs of circulation CHECK FOR SIGNS OF CIR-
CULATION
If no signs of circulation, give two breaths, 15 CHEST COMPRESSIONS
then 15 chest compressions - continue. THEN 2 RESCUE
BREATHS - CONTINUE

Art. no.: 0-48-0060 Rev.: a

Page 50
Defibrillation 5
DEFIGARD 5000 User Guide Semiautomatic Defibrillation 5.7

5.7.2 Defibrillation - Procedure


When the device is switched on, it gives spoken and displayed instructions up to the
defibrillation. Exactly follow the instructions.

Step 1 Switching on and Preparing the Device


1. Insert the adapter for the adhesive electrodes.
2. Switch on the device by pressing the green button.
3. Check the state of the patient.
4. Connect the electrode cable to the adapter.
5. You are prompted to apply the electrodes.
6. Apply the defibrillation electrodes (see section 5.4.1, page 42). The message
CONNECT THE ELECTRODES is switched off as soon as the device measures
an acceptable electrode resistance. If it is not switched off, see section 5.4.1.
Fig. 5.9 Switch unit on

Step 2 Analysis
7. You are prompted to start the analysis.
8. Press the blue button. You are prompted not to touch the patient any more.

If the device detects ventricular fibrillation or ventricular tachycardia with a heart rate
exceeding 180 pulse/min, shock delivery follows (see step 4 - Shock Delivery); other-
wise continue with Step 4, Cardiopulmonary Resuscitation.
Fig. 5.10 Analysis
Art. no.: 0-48-0060 Rev.: a

Page 51
5 Defibrillation
5.7 Semiautomatic Defibrillation DEFIGARD 5000

Step 3 Shock Delivery


As soon as the energy for a shock is charged, the device prompts the user to deliver
the shock by pressing button 3.
V Danger of electric shock!
• Do not, under any circumstances, touch the patient during shock delivery.
• Make sure that the patient does not touch any conducting objects.

9. Deliver the shock by pressing the button .

After shock delivery, the device checks if the shock has been successful by car-
rying out an automatic analysis. If the shock was not successful, the steps 2 to 3
are repeated once or twice, whereas the preset energy levels for the 2nd and 3rd
shocks are charged. Then step 4 follows.

Step 4 Cardiopulmonary Resuscitation


Prompt to check the patient's respiration and circulation.
10. Check the patient.
– If no sings of circulation are present, carry out cardiopulmonary resuscitation.
Art. no.: 0-48-0060 Rev.: a

Alternate between two breaths and 15 cardiac massages for one minute. After
one minute, the device begins again with Step 2, Cardiopulmonary Resuscita-
tion.
– If circulatory signs are present, move the patient onto his or her side.

Page 52
Defibrillation 5
DEFIGARD 5000 User Guide Defibrillator Error Messages 5.8

5.8 Defibrillator Error Messages


Alarm Cause Remedy
SYNCHRO END • No pulse « Check ECG
BAD CASSETTE • Wrong cassette connected « Use the correct cassette
• Cassette has not completely « Lock the cassette into place
locked into place
Art. no.: 0-48-0060 Rev.: a

Page 53
6 Pacemaker
6.1 Pacemaker Function DEFIGARD 5000

6 Pacemaker
6.1 Pacemaker Function
The pacemaker is the module for external transthoracic stimulation of the heart.
The pacemaker offers two modes of operation, demand and fixed-rate pacing. The
overdrive mode can be used to correct conditions of tachycardia. In demand mode,
the pacemaker requires an ECG signal for synchronisation.
The same, large-surface adhesive electrodes used for defibrillation are also em-
ployed for pacing. They ensure good electrical contact with the skin. These elec-
trodes and a 40 ms square-wave pulse reduce painful muscle contractions provoked
by excessive current density.
It is not possible to simultaneously connect pads for defibrillation and for pacing.
Pacer rate, pulse width and current are checked when the device is turned on and
during operation; therefore a functional test of the pacemaker module is not neces-
sary.

6.1.1 Fixed-Rate Mode (Fix)


In this operating mode, the module delivers pacing pulses with user-defined current
at a user-defined rate. The selected rate remains constant and is not affected by in-
trinsic actions of the patient's heart. This is the preferred mode for cases of cardiac
arrest.

6.1.2 Demand Mode


In demand mode, the pacemaker does not deliver pacing pulses as long as the pa-
tient's intrinsic heart rate exceeds the set pacing rate. When the heart rate drops be-
low the pacing rate, the pacemaker starts emitting stimulation pulses. This can only
be ensured by continued monitoring of the ECG. The pacemaker receives the nec-
essary ECG signal via the ECG electrodes. If the module is not able to reliably iden-
tify QRS complexes, it will stimulate the heart permanently in demand mode.
The demand mode is the recommended pacing mode when the patient is at risk of
developing bradycardia or even asystole as a result of a critical event. As the pace-
maker function is controlled by the patient's ECG, the harmful competition between
intrinsic and external stimulation, which could induce ventricular fibrillation, is exclud-
ed.

6.1.3 Overdrive Mode


In the overdrive mode, the pacer will operate at three times the selected rate.
Art. no.: 0-48-0060 Rev.: a

This operating mode should be selected to correct conditions of tachycardia. The


heart is stimulated with a rate that is above the intrinsic heart rate. At the end of the
intervention, the heart rate should return to a normal rhythm.

Page 54
Pacemaker 6
DEFIGARD 5000 User Guide Safety Notes 6.2

6.2 Safety Notes


V Shock hazard!
Never touch the pads or the patient's body near the pads while the pacemaker
is in use.

V Patient hazard, equipment failure!


Equipment delivering electrical energy to the patient at the same time as the
pacemaker can disturb the pacemaker function. Particularly HF surgery equip-
ment used on a pacemaker patient may cause interference, preventing the de-
tection of QRS complexes. In this situation, the pacemaker must be set to fixed-
rate pacing (FIX). Also please note that leakage currents could be transferred to
other electric circuits, interfering with the functioning of devices connected to
these circuits.
V For safety reasons, the external pacemaker should be disconnected from the
patient in this situation and an internal pacemaker should be used.
V Accessories, wearing parts and disposables that affect the safe use of the pace-
maker and that are to be used in conjunction with the pacemaker must be tested
for safety and approved by an authorised test laboratory.

6.3 Guidelines for the Application of External


Pacemakers
These guidelines apply to all pacemakers, irrespective of type and manufacturer.
All electrical devices that deliver energy to patients in any form or have an electrically
conductive connection to the patient are a potential source of danger.
As the user is responsible for the safe application of the devices, observance of the
instructions given in the user manual and of the guidelines below is of utmost impor-
tance.
• Pacemakers must only be used under the supervision of qualified and authorised
staff.
• Observe the user guide for the pacemaker's operation.
• The patient must not be left unattended during pacing.
• It is assumed that the patient's ECG is being monitored to be able to assess the
effect of pacing.
• When positioning the patient, take care that no electrically conductive connections
exist between the patient and earthed metal parts (puddles of water, for instance,
are capable of conducting the electrical current). Although the pacer current output
is required to be floating, this is an additional safety precaution to ensure that the
pacemaker current pulse flows only between the pacemaker electrodes.
• Set all values for the pacemaker to position 0, or the lowest value.
Art. no.: 0-48-0060 Rev.: a

• Position stationary pacemakers close to the patient.


• After each defibrillation, check that the pacemaker is functioning properly.

Page 55
6 Pacemaker
6.3 Guidelines for the Application of External Pacemakers DEFIGARD 5000

6.3.1 Attaching the Pacer Pads

• The same electrodes used for defibrillation are also employed for pacing.
• For children with a body weight under 15 kg, pads with a surface of 28 cm2 should
be used.
• For children weighing more than 15 kg, pads with a surface of 78 cm2 should be
used.

The application of electrodes is detailed in section 5.4.1 on page 42.

Anterior-Posterior Placement

1. Apply the dorsal electrode (+) to the left scapular area and the precordial elec-
trode (-) near the left lower sternal edge.
2. Connect the pace pads to the device.
If the dorsal electrode cannot be used, apply anterior-anterior placement.

Dorsal electrode

Fig. 6.1 Anterior-posterior placement

Anterior-Anterior Placement

1. Apply the “+” electrode on the right side below the clavicle and the “-” electrode to
the left of the axillary line on a level with the 5th intercostal space so they do not
hinder heart massage.
2. Connect the pace pads to the device.

Fig. 6.2 Anterior-anterior placement Art. no.: 0-48-0060 Rev.: a

Page 56
Pacemaker 6
DEFIGARD 5000 User Guide Start-up of the Pacemaker 6.4

6.4 Start-up of the Pacemaker


• The device can at any time be switched from defibrillation to pacing mode if re-
quired.
• When the pacemaker is switched on, the current value is set to 0.

6.4.1 Pacemaker Display

Softkeys for defi- Softkeys for pace- 1. Select the defibrillator display using the navigation button.
brillator maker 2. Display the pacemaker function by pressing the STIM softkey .
The softkeys for the pacemaker settings (Fig. 6.3) and the pacemaker values are dis-
mA + played.

mA -

Charge P x3
On-off

STIM DEFI

Freq

Fig. 6.3 DEFI and STIM softkeys

6.4.2 Selecting Pacemaker Mode

1. Select the defibrillator display using the navigation button.


Mode 2. Press the navigation button. The Mode softkey is displayed.
3. Press the Mode key to select the operational mode Fix or Demand.
4. The operational mode is displayed in the defibrillation window (1).
Menu
1
Edition Dem
S
T
I
M
40 35
p/min mA
Fig. 6.4 Pacemaker mode
Art. no.: 0-48-0060 Rev.: a

Page 57
6 Pacemaker
6.4 Start-up of the Pacemaker DEFIGARD 5000

6.4.3 Pacemaker Settings Operational Mode Fix


Softkeys for pace- 1. Display pacemaker and select operational mode fix. (See page 57.)
maker 2. Set the pacer rate using the function keys P +/-.
3. Display the keys for the pacer output by pressing the Current softkey.
P+ mA +

P- mA - V Shock hazard!
Never touch the pads or the patient's body near the pads while the pacemaker is
in use.
P x3 P x3
4. Set the pacer output using the buttons mA +/- until the heart will certainly react on
the stimulation.
5. After completion of the therapy, set the pulse rate and current to the minimum val-
DEFI DEFI ue before carefully tearing off the electrodes from the patient.
Current Freq

Fig. 6.5 Softkeys for pacemaker

6.4.4 Demand Mode


1. Record an ECG with patient cable as described in section on page 25.
2. Attach the pacer pads (See page 56.)
3. Display pacemaker and select operational mode Demand. (See page 57.)

Dem 4. Increase the pulse rate using the button P + until the symbol on the display
S
T 40 35 starts flashing. The pulse rate has now reached or slightly exceeded the intrinsic
heart rate.
I
M 5. Increase the impulse current using the button mA + until the heart reacts to the
p/min mA stimulation (QRS complexes visible on the display).
6. Now set the required pulse rate using the P +/- keys.
Fig. 6.6 Intrinsic heart rate indicator 7. When the therapy is finished, switch the pacemaker off and carefully remove the
flashes electrodes.

Art. no.: 0-48-0060 Rev.: a

Page 58
Pacemaker 6
DEFIGARD 5000 User Guide Start-up of the Pacemaker 6.4

6.4.5 Overdrive Mode


Softkeys for pace- 1. Start the pacemaker as described in section 6.4 on page 57.
maker 2. Set the pacemaker mode to Fix. The P x3 softkey is displayed.
3. Keep P x3 pressed while increasing the pulse current using the button mA + until
the heart has reached the pacemaker's rate.
mA +
4. Now let the P x3 key go. The heart should continue to beat with a normal heart
rate.
mA - 5. Finish the therapy.

P x3

DEFI

Freq

Fig. 6.7 Softkeys for pacemaker


Art. no.: 0-48-0060 Rev.: a

Page 59
7 Finishing the Therapy
6.4 Start-up of the Pacemaker DEFIGARD 5000

7 Finishing the Therapy


1. Switch the device off as soon as the therapy is finished (keep the button pressed
for approx. 2 seconds).
2. Disconnect the plug of the electrode line.
3. Carefully remove the electrodes from the patient's skin.
4. Discard the disposable pads immediately after use to prevent their reuse (hospi-
tal waste).
5. Sterilise the spoon electrodes immediately after use.
6. Clean the device as described in section 10.

Art. no.: 0-48-0060 Rev.: a

Page 60
Intervention Summary 8
DEFIGARD 5000 User Guide Start-up of the Pacemaker 6.4

8 Intervention Summary
To document the intervention, the ECG (30 minutes, 1 lead) and the intervention
(500 events max.) are saved.
Overview of events documented with date and time:
• Power on
• Start of analysis
• Analysis result
• Defibrillator charging
• Defibrillation shock
• Internal discharge
• Switchover to manual operation
• Electrode alarm
• "Battery low" alarm
• Activation of a vital signs module
• Deactivation of a vital signs module
• Asystole alarm (manual mode)
• Fibrillation/flutter alarm (manual mode)
• Event button
Art. no.: 0-48-0060 Rev.: a

Page 61
8 Intervention Summary
8.1 Printing Curves and Measured Values DEFIGARD 5000

8.1 Printing Curves and Measured Values


The curves and parameter settings to be printed and the printing length are de-
scribed on page 66, section 9.1.5.

1. Press the Start/stop printout key. If no or a 3-lead ECG cable is connected, the
set curves are printed directly. With a 4 - or 10-lead patient cable, the keys for the
available print options are displayed.

2. Start the printout by pressing the respective print option key.


Fig. 8.1 Start/stop printout key
3. The printout can be stopped at any time using the start/stop printout key.

Print Options
1 (1) Printout of the set curves with set printing length and parameter values. (The
print settings are described in section 9.1.5.)
2 (2) Printout of the set curves until the printout is stopped using the start/stop key,
and the parameter values. (The print settings are described in section 9.1.5.)
(3) Printout of all ECG curves and measured values.
3

Fig. 8.2 Print option keys

8.1.1 Example of a Defibrillator Shock Printout

Text block with registration Shock energy and cur- Readings of the moni-
ECG curve
data rent tored parameters

2 5 mm/ s 0. 5 Hz - 2 5Hz
DG 5 00 0 95 0 00 67
V0 2. 0 0 12 /0 9 /2 0 05 1 3: 3 4

S ta rt : : De f i s ho c k 08 / 09 / 20 05 1 6: 4 4
Cu rve (s) : E CG
H i s t or y : 8 s e c on ds HR : 71 bp m
D EFI ¦ W d el ¦ I p at ¦ R pa t ¦ Sp O 2 : 98 %
¦ 1 3 1 J ¦ 48 A ¦ 5 6 Ω ¦ NIBP sys : 12 5 mm Hg
Ma p : 09 5 mm Hg
DIA : 09 0 mm Hg

Art. no.: 0-48-0060 Rev.: a

8.1.2 Printer Error Messages


Alarm Cause Remedy
RECORDER: NO PAPER! • No paper in the printer « Insert paper
RECORDER: DOOR OPEN! • Printer door is open « Close the door

RECORDER: TIME OUT! • Paper jam in the printer « Remove the paper jam

Page 62
Default and User-Defined Thresholds 9
DEFIGARD 5000 User Guide Printing Curves and Measured Values 8.1

9 Default and User-Defined


Thresholds
For the monitoring of vital parameters, physiological alarm thresholds are preset in
the DEFIGARD® 5000, which are activated when the device is turned on. The device
distinguishes between default and user-defined thresholds for adults and ne-
onates. The user-defined thresholds can be changed in the respective menus; the
default thresholds are changed in the device configuration menu (see page 67,
section 10).
All changes are saved. When the device is put into operation for the first time, the
user-defined thresholds are identical with the default thresholds.

1. Press the navigation button. When the navigation button is pressed twice, the
main menu is directly opened and step 2 is dropped.
Main menu 2. Press the Menu softkey. The main menu is displayed.
3. Select, display and modify the menu by turning and pressing the button.
ECG Menu 4. To access the threshold menu directly, press .
5. The time, volume and printer configuration can be set via the unit settings button
SpO2 Menu
.
NIBP Menu

Fig. 9.1 Main menu


Art. no.: 0-48-0060 Rev.: a

Page 63
9 Default and User-Defined Thresholds
9.1 User-Defined Thresholds DEFIGARD 5000

9.1 User-Defined Thresholds


The settings are detailed in section 4. The following table gives an overview of the
user-defined thresholds, with the factory defaults in bold letters.

9.1.1 ECG Menu


The thresholds are only displayed after the user's threshold values have been
opened once in the threshold values menu .
Menu Parameter Value
ECG Number of curve(s) 0 / 1 / 2 / 3 / 6 /12
Lead channel 1 Defi/I, II, III/aVR, aVL, AVF/V1, V2,
V3/V4, V5, V6
Lead channel 2 aDefi/I, II, III/aVR, aVL, AVF/V1, V2,

V3/V4, V5, V6
0.25/0.5/1/2 cm/mV

HR ECG/HR SpO2

QRS beep Off/Low/Medium/High


Speed 25/50 mm/s
Patient Adult/Neonate
High threshold (140...300)/Off
Low threshold Off/60 (range 30...125)
a. The "Defi" option is only available when a patient cable and an adapter module
with defibrillation electrodes are connected.

9.1.2 SpO2 Menu


The threshold values are only displayed after the user's threshold values have been
opened once in the threshold values menu .

Menu Parameter Value


SpO2 SpO2 curve Yes/no
Average Cycles 8/16 seconds
HR ECG/HR SpO2

Speed 25/50 mm/s


Patient Adult/Neonate
Art. no.: 0-48-0060 Rev.: a

High pulse threshold (130...250)/Off


Low pulse threshold Off/50 (range 30...125)
High SpO2 threshold 100/Off (range 55...250)
Low SpO2 threshold Off/85 (range 50...99)

Page 64
Default and User-Defined Thresholds 9
DEFIGARD 5000 User Guide User-Defined Thresholds 9.1

9.1.3 NIBP Menu


The thresholds are only displayed after the user's threshold values have been
opened once in the threshold values menu .
Menu Parameter Value
NIBP Manual, Continuous or cycle of 1 / 2 /
3 / 5 /10 /15 /20 / 30 / 40 / 90 minutes

Patient Adult/Neonate
Unit mmHg / kPa
High SYS threshold 180 (70...250)
Low SYS threshold 70 (Off/50...225)
High MAP threshold 160 (25...250)
Low MAP threshold 50 (Off/20...245)
High DIA threshold 110 (15...200)
Low DIA threshold 40 (Off/10...195)

9.1.4 User-Defined Thresholds Menu


The thresholds menu is accessed via the menu or threshold key . The values
can be selected and changed using the navigation key.
Menu Parameter Min. Max. Unit
ECG HR 70 150 p/min
SpO2 PULS 50 130 p/min
% 85 100 %
NIBP SYS 70 180 mmHg
Map 50 160 mmHg
DIA 40 110 mmHg

With the Default key, the default threshold values are copied into the operator table.

Default With the key, all values are deactivated.


With the Quick Set key, all values are derived from the current measured values.
– Low threshold = -20 %
– High threshold = +20 %
Quick Set
Exit the menu by pressing Enter.
Art. no.: 0-48-0060 Rev.: a

Fig. 9.2 Softkeys in the threshold menu

Page 65
9 Default and User-Defined Thresholds
9.1 User-Defined Thresholds DEFIGARD 5000

9.1.5 Unit Settings Menu


Access the unit settings menu via the menu or the button. The values can be
selected and changed using the navigation button.

Menu Parameter Value Note


• Day - When the date and time are changed, the data
in the trend memory is deleted.

• Month - -
• Year - -
• Hour - -
• Minute - -
• Date format DD/MM/YY or MM/DD/YY -
• Summer/winter time Yes/no -
• Alarm sound High, Medium, Low -

• QRS sound High, Medium, Low, Off -


• Pace sound High, Medium, Low, Off -
• Key sound High, Medium, Low, Off -
• Language High, Medium, Low, Off -
• Manual printing ECG, Puls, ECG/ECG, ECG/ Selection of values to be printed on
Puls manual printouts

• Alarm printing ECG, Puls, ECG/ECG, ECG/ Selection of values to be printed on au-
Puls, ECG/Alarm tomatic printouts (“Printing on alarm”)
• Printing on alarm No, HR only, All alarms Alarm events which should trigger a
printout
• Printing on shock Yes, No
• History “No history” or “8 s” Printout including 8 seconds before the
printout trigger
• Printing length (page) 2, 3, 4, 5, 6 Number of pages per printout
• Lead change (page) 2, 3, 4 Length of lead printouts
Defibrillator • Synchro modification “Key” or “Automatic”
• Synchro at start “Direct” or “Synchro”
• Synchro with paddles Set to Yes or No
• Mode at start “SAED” or “Manual”
• ERC protocol 1 or 3 min
Demo mode For demonstration only Only accessible with a pass- Display of curves and measured values
Art. no.: 0-48-0060 Rev.: a

word without sensors

Page 66
Default Values 10
DEFIGARD 5000 User Guide Default Threshold Values for Adults 10.1

10 Default Values
To change the default values, access the DEVICE CONFIGURATION menu as fol-
lows:

« Keep the navigation button pressed while switching on the device.


DEVICE CONFIGURATION

Saving the Values


After the threshold values and parameters have been set, the device must be
switched off.

[Ether]

Options

Releases

Fig. 10.1 DEVICE CONFIGURATION


menu

10.1 Default Threshold Values for Adults


Menu Parameter Min. Max. Unit
ECG HR 50 130 p/min
SpO2 PULS 50 130 p/min
% 85 100 %
NIBP SYS 70 180 mmHg
Map 50 160 mmHg
DIA 40 110 mmHg

10.2 Default Threshold Values for Neonates


Art. no.: 0-48-0060 Rev.: a

Menu Parameter Min. Max. Unit


ECG HR 50 130 p/min
SpO2 PULS 50 130 p/min
% 85 100 %
NIBP SYS 50 140 mmHg
Map 40 120 mmHg
DIA 30 100 mmHg

Page 67
10 Default Values
10.3 Default Device Settings DEFIGARD 5000

10.3 Default Device Settings


10.3.1 Alarms
Menu Parameter Value
• -4 % SpO2 alarm Yes/no

• Elec. fault with paddles Yes/no


• Physiological alarms Locked/Not locked
• 2’ alarm rejection at start Yes/no
Yes/no
This setting is not allowed in
all countries
Permanent alarm switch-off
• VF alarm in manual Yes/no
• Alarms in SAED Yes/no
• Defi ready in SAED Yes/no

10.3.2 NIBP
Menu Parameter Value
NIBP • CONT mode length 5 min (5 - 15 min)
• Cycle after CONT mode 3 min (1 - 90 min)

10.3.3 Language
Menu Parameter Value
Language Deutsch, English, Français,
? Italiano, Português, Español

10.3.4 Screen Colour


Menu Parameter Value
Screen Colour Colour 1, 2, 3

10.3.5 Mains Filter


Menu Parameter Value
Art. no.: 0-48-0060 Rev.: a

Mains Filter Mains filter 50, 60 Hz, None

10.3.6 Serial Number


Menu Parameter Value
Serial Nb Serial Nb Can only be changed by the
manufacturer

Page 68
Default Values 10
DEFIGARD 5000 User Guide Working Hour Meter 10.4

10.3.7 Hardware Number


Menu Parameter Value
Hardware Nb Hardware Nb Can only be changed by the
manufacturer

10.4 Working Hour Meter


Menu Parameter Value
Runtime Days/hours/minutes

Standby Days/hours/minutes
Lower battery Capacity in %
Upper battery Capacity in %

The working hour meter can only be reset by the manufacturer.

10.5 Ethernet
Menu Parameter Value
[Ether] Mac address Can only be changed by the
manufacturer
Ip address User Defined
Subnet mask User defined
Gateway User defined

10.6 Options
Menu Parameter Value
Options SpO2 Yes/no
Non Invasive Blood Pressure Yes/no
Printer Yes/no
Semiautomatic mode Yes/no
Pacemaker Yes/no
ECG memory Yes/no
Art. no.: 0-48-0060 Rev.: a

Page 69
10 Default Values
10.7 Releases DEFIGARD 5000

10.7 Releases
Menu Parameter Value
Releases Group Soft xy
FPGA xy
Host xy
Analog xy
Pacemaker xyxy
SPO2 xy
NIBP xy
ECG xy
VF / VT xy
Power xy
Defibrillator xy

10.8 PC Download
This function is only used for software downloads. To leave the menu, press the "De-
lete" key twice.

10.9 Locking the Device


Transport Lock
A locked device will switch off automatically if it is not operated for 5 seconds.
To unlock the device, follow the instructions on the screen.
This menu can only be accessed with the factory password.

Art. no.: 0-48-0060 Rev.: a

Page 70
Maintenance 11
DEFIGARD 5000 User Guide Maintenance Interval 11.1

11 Maintenance
11.1 Maintenance Interval
Note
The unit must be serviced on a regular basis. The test results must be recorded and
compared to the values in the accompanying documents.
The following table indicates the intervals and responsibilities of the maintenance
work required.

Interval Maintenance Responsible


Before each use • Visual inspection of the device and electrodes « User
• Visual inspection of the device and electrodes « User
Monthly
• Check of the electrodes' expiration date
Every 4 months • Function inspections according to the instructions « User
• All measurement inspections and calibration according to the instruc- « Service staff authorised by
Every 12 months tions in the service handbook SCHILLER AG
Every 5 years • Battery replacement « User

11.1.1 Visual Unit Check


Inspect the device and electrodes for the following:
« Device casing not deformed?
« Electrode connection undamaged?
« Expiration date on the electrode package
Defective units or damaged cables must be replaced immediately.

11.1.2 Defibrillator Test

This test can only be carried out with paddles.

V Danger of electrical shock. The metal parts of the paddles must not be touched
while a shock is triggered.
V To prevent the bleeder resistor from overheating, this test must never be carried
out several times in a series.

1. Connect the paddles and set the energy to 90 joules.


Art. no.: 0-48-0060 Rev.: a

2. Hold the paddles together and trigger a shock into the device.
3. Recorder printout with the message: DEFIBRILLATOR TEST – Date – OK.

Page 71
11 Maintenance
11.1 Maintenance Interval DEFIGARD 5000

11.1.3 Functional Test


« Switch the device on and carry out a self-test.

11.1.4 Alarm Tests

Heart rate 1. Start the ECG monitoring (see section 4.3.4, page 28).
2. Set the high and then the low heart rate threshold below/above the measured val-
ues.
3. An alarm is issued.
Reset the alarm limits to their original values.

SpO2 See section 4.4, page 30.

NIBP 1. Start the NIBP monitoring (see section 4.5.1, page 33).
2. Set the NIBP alarm limits below/above the measured values and take a new
measurement.
3. When the measured value exceeds the alarm limit, an alarm is issued.
4. Reset the alarm limits to their original values.

If the device does not behave as described in this user guide, there is an error that
must be repaired by the after-sales service.

Art. no.: 0-48-0060 Rev.: a

Page 72
Maintenance 11
DEFIGARD 5000 User Guide Maintenance Interval for the Battery 11.2

11.2 Maintenance Interval for the Battery


Important
The battery is maintenance free during its normal life.
The battery must be replaced after five years, regardless of whether the device has
been used or not.

11.2.1 Battery Disposal

V Danger of explosion! Battery may not be burned or disposed of domestic refuse.


V Danger of acid burns! Do not open or heat up the battery.

The battery is to be disposed of in municipally approved areas or sent back to


SCHILLER AG.

11.2.2 Disposal at the End of the Device's Useful Life

The device must be disposed of in a municipally approved collection point or recy-


cling centre.
If there is no local collection point or recycling centre in your area, you can return the
device to the distributor or the manufacturer for proper disposal. In this way, you con-
tribute to the recycling and other forms of utilisation of old electrical and electronic
equipment.
Improper disposal harms the environment and human health due to dangerous sub-
stances contained in electrical and electronic equipment.
Art. no.: 0-48-0060 Rev.: a

Page 73
11 Maintenance
11.3 Cleaning DEFIGARD 5000

11.3 Cleaning
11.3.1 Cleaning the Casing

V Switch the unit off before cleaning and remove the battery. Do not, under any cir-
cumstances, immerse the apparatus into a cleaning liquid or sterilise with hot wa-
ter, steam, or air.
V Do not use any phenol-based agents or peroxide compounds for cleaning.

« Wipe the unit's casing with a tissue dampened in a cleaning or disinfection solu-
tion (70% alcohol). Make sure that no liquid enters the unit.
« Discard the disposable pads immediately after use to prevent their reuse (hospi-
tal waste).
« The paddles and their leads can be cleaned and disinfected by wiping them down
with a gaze pad moistened with soap water or disinfectant. Before using the pad-
dles again, however, make sure that they are not completely dry.
« The spoon electrodes can be cleaned in the same way. Further more, these elec-
trodes and the connection cables can be sterilised with ethylene oxide, vapour
(134 °C) or ionising radiation. Ensure that internal defibrillation electrodes are
sterilised before each use!
« Before cleaning the electrode or sensor leads, disconnect them from the device.
The lines can be cleaned and disinfected by wiping them down with a gaze pad
moistened with cleaning agent or disinfectant. Do not immerse the cable connec-
tors in liquid. The device can be cleaned with all cleaning agents and disinfect-
ants commonly used in hospitals.

11.3.2 Accessories and Disposables

V Always use SCHILLER replacement parts and disposables, or products ap-


proved by SCHILLER. Failure to do so may endanger life and invalidate the guar-
antee.

Your local representative stocks all the disposables and accessories for the DEFI-
GARD® 5000. A full list of all SCHILLER representatives can be found on the
SCHILLER website (www.schiller.ch). In case of difficulty, contact our head office in
Switzerland. Our staff will be pleased to help process your order or to provide any de-
tails for all SCHILLER products.

Art. no.: 0-48-0060 Rev.: a

Page 74
Maintenance 11
DEFIGARD 5000 User Guide Error Detection 11.4

11.4 Error Detection


11.4.1 General Errors
Error Cause Remedy
The screen is not lit when • Battery not correctly inserted or « Correctly insert or replace the battery
the device is switched on defective

• Device defective « Replace the device


The device cannot be • Green button was pressed for « Keep the green button pressed for at least 3 seconds
switched off less than 3 seconds
• Device defective « Replace the device
No analysis • ECG signal too weak « Resume the heart massage
• ECG signal disturbed by electro- « Switch off the interfering device, e.g. wireless equipment
magnetic waves or handy, or move the patient out of the noise field
• Patient moved or touched during « The patient must not move or be touched during the
the analysis analysis
• Device defective « Replace the device
No shock can be delivered • Battery charge too low « Change batteries
• Electrode defect caused by re- « Reapply electrodes
suscitation measures
• Heart rate has changed « Repeat the analysis
• Device defective « Replace the device
Art. no.: 0-48-0060 Rev.: a

Page 75
11 Maintenance
11.4 Error Detection DEFIGARD 5000

11.4.2 Technical Error Messages


Alarm
CARD ERROR! • Technical error « Replace the device
ANALOG BOARD! • Technical error « Replace the device
POWER CARD ERROR! • Technical error « Replace the device
Trend Error • Technical error « Replace the device
PROCESSOR ERROR • Technical error « Replace the device
PROGRAM ERROR • Technical error « Replace the device
ERROR DETECTION CIRCUIT FAILED • Technical error « Replace the device
SELECTED ENERGY VOLTAGE REFERENCE • Technical error « Replace the device
FAILED
ANALOG/DIGITAL CONVERTER ERROR • Technical error « Replace the device
CHARGE TRANSISTOR ERROR • Technical error « Replace the device
SAFETY DISCHARGE CIRCUIT FAILED • Technical error « Replace the device
COMPENSATION EPROM FAILED • Technical error « Replace the device
SHOCK BUTTON FAILED • Technical error « Replace the device
DEFI TIME OUT • Technical error « Replace the device
CHARGE CIRCUIT FAILED • Technical error « Replace the device
IGBT ERROR • Technical error « Replace the device
PIC POWER SUPPLY FAILED • Technical error « Replace the device
NO COMPATIBILITY BETWEEN HARDWARE • Technical error « Replace the device
AND SOFTWARE

Art. no.: 0-48-0060 Rev.: a

Page 76
Technical Data 12
DEFIGARD 5000 User Guide System Data 12.1

12 Technical Data
Where nothing else is indicated, the data refer to a temperature of 25 °C.

12.1 System Data


Manufacturer SCHILLER MEDICAL

Device name DEFIGARD® 5000

Dimensions 289 x 271 x 177 mm (h x l x w)

Weight 5.3 kg

Protection case IPX 1 (drip-proof)

Power Supply
Voltage 100 - 240 VAC 50/60 Hz
Power consumption 120 VA
Battery operation Up to 2 hours; up to 4 hours with additional battery
Fuses 2 x 200 mA (T) at 250 VAC, 2 x 315 mA (T) at 115 VAC
External power supply 11.5 - 48 VDC max., 2.5 A
The unit is suitable for use in networks according to IEC 60601-1-2.

Battery
Battery type Lithium/ion 10.8 V, 4.3 Ah
Autonomy 190 shocks with maximum energy or 2 hour monitoring (with one battery)

Environmental conditions
For operation • 0 ºC...40 ºC relative humidity at 30...95% (noncondensing)
• Atmospheric pressure 500...1060 hPa
For storage and transport • -10 ºC...50 ºC relative humidity at 0...95% (noncondensing)
• Atmospheric pressure 700...1060 hPa

Display
Type High-resolution colour LCD, backlit
Dimensions 211.4 x 158.4 mm (10.4 “)
Art. no.: 0-48-0060 Rev.: a

Printer High resolution thermo-printer

Resolution 8 dots/mm (amplitude-axis), 40 dots/mm (time-axis) at 25 mm/s


Paper Thermoreactive, Z-folded, 72 mm width, length approx. 20 m
Print speed 25, 50 mm/s
Recording tracks 3-channel display, with optimal width of 72 mm

Connections ECG patient cable , SpO2, NIBP

Page 77
12 Technical Data
12.1 System Data DEFIGARD 5000

Interfaces • RS-232
• Analog for QRS trigger, 1-channel ECG and remote alarm (no delay compared to
device alarm)
• USB
• Ethernet
• For pins and the signal type, please contact the SCHILLER after-sales service.

Safety standard IEC/EN 60601-2-4


The device is designed for 2500 shocks

EMC • IEC/EN 60601-1-2


• IEC/EN 60601-2-4
• CISPR 11 class B
The device can be exposed to the following interferences without any impairment:
• Static discharge up to 8 kV
• Energy in the radio frequency range up to 20 V/m (80...2500 MHz, 5 Hz modulat-
ed)
• Magnetic fields of 100 A/m, 50 Hz

Conformity CE according to directive 93/42/EEC class IIb

Safety class Class I according to IEC/EN 60601-1

Art. no.: 0-48-0060 Rev.: a

Page 78
Technical Data 12
DEFIGARD 5000 User Guide Defibrillation Pulse 12.2

12.2 Defibrillation Pulse


Form • Biphasic pulsed defibrillation impulse with fixed physiological optimum phase du-
rations
• Near stabilisation of the emitted energy in function with the patient resistance us-
ing pulse-pause modulation depending on the measured patient resistance.

Standard energy settings Deviation at 50Ω: ± 3 J oder ± 15 % (the higher value is assumed)
Adult AED • 130/130/150 joules (configurable)
Paediatric AED • 15/30/50 joules (configurable)
(automatic switch when the pediatric electrodes are connected)
Paddle • 0, 2, 4, 8, 15, 30, 50, 90, 130, 180 joules
Adhesive electrodes • 2, 4, 8, 15, 30, 50, 70, 90, 110, 130, 150, 180 joules
Internal • 2, 4, 6, 8, 15, 30 joules

Charging time for shock (Time used to charge the storage capacitor to the max. energy of 180 J in manual
mode)
• with full battery 8 seconds
• with 90 V mains voltage after 9 seconds
15 discharges with max. energy
emission
• from switch-on of the device with 18 seconds
paddles
• from switch-on of the device with
25 seconds
pads

Cycle Time Rhythm Analysis –


Shock Standby in AED Mode
Art. no.: 0-48-0060 Rev.: a

• with full battery 1st shock = 20 s; 2nd shock = 40 s; 3rd shock = 60 s


• with 90 V mains voltage after
1st shock = 20 s; 2nd shock = 40 s; 3rd shock = 60 s
15 discharges with max. energy
emission
• from switch-on of the device to
charge at max. energy 1st shock = 35 s; 2nd shock = 55 s; 3rd shock = 75 s

Cycle time shock - shock <25 s

Page 79
12 Technical Data
12.2 Defibrillation Pulse DEFIGARD 5000

Operating Modes Synchronised with heart action 25 ms after R wave


Unsynchronised
AED

Charge control and monitoring • Automatic shock recommendation of analysis in AED mode
• Using the set wheel on the paddle
• Using the device's keyboard
Display of selected energy

Patient resistance 30...220 Ω

Display of shock standby


Key is lit

Shock delivery
Using key

Safety discharge when: • the battery voltage is insufficient


• the device is defective
• the device is turned off

Shock delivery • Via applied disposable adhesive defibrillation electrodes


• Via paddles
• Via spoons

Defibrillation electrode connec-


tion
External defibrillation BF type
Internal defibrillation Type CF

Defibrillation electrodes Electrode cable 1.95 m long


Adult electrode • 78 cm2 active surface
Pediatric electrode • 28 cm2 active surface

VF/VT detection Conditions for ECG analysis


VF/VT detection is only based on the ECG signal.
Minimum amplitude for analysable signals > 0.15 mV; signals < 0.15 mV are as-
sessed as asystole
Shock recommendation
In case of VF and VT (VT > 180 p/min)
Sensitivity 96.4 %
Art. no.: 0-48-0060 Rev.: a

Correct detection of shockable rhythms


Specificity 99.8 %
Correct detection of non-shockable rhythms These values were determined with an
AHA database containing VF and VT with or without artefacts.

Page 80
Technical Data 12
DEFIGARD 5000 User Guide Technical Data - Measured Values 12.3

12.3 Technical Data - Measured Values


12.3.1 ECG

Leads Simultaneous, synchronous recording of all 9 active electrodes giving 12 leads

Patient cable 3-,4-, 10-lead cable, type CF

Heart rate
Range • 30 – 300 beats/min
Accuracy • ±2 beats/min

Lead display Selection of 1 or 12 simultaneous leads

Sensitivity 0.25, 0.5, 1, 2 cm/mV programmable

ECG amplifier
Band pass 0.5...35 Hz or 0.05...150 Hz (depending on the ECG source)

Blockage caused by defibrilla- Max. 5 seconds


tion shock

12.3.2 NIBP - Non-Invasive Blood Pressure

Measurement Automatic or manual

Measuring method Oscillometric

Connection Type CF

Measurement range
Adults • Sys 30...255 mmHg, dia 15...220 mmHg
Neonates • Sys 30...135 mmHg, dia 15...110 mmHg

Accuracy ± 3 mmHg and ± 2 beats/min


Art. no.: 0-48-0060 Rev.: a

Page 81
12 Technical Data
12.4 Technical Pacemaker Data DEFIGARD 5000

12.3.3 SpO2 - Pulsoximetry

Amplifier Masimo™

Operation Normal and sensitive

Accuracy SpO2
• Adults 1 to 100% ± 2 digits
• Neonates 70 to 100% ± 3 digits
PP
• 25...240/min ± 4 digits

Calibration range 70...100%

Connection Type CF

Measurement range SpO2 1...100%


PP 25...240/min

Displayed range 1...100%

Blockage caused by defibrilla- Max. 10 seconds


tion shock

12.3.4 Storage of Intervention (Option)

Saving
ECG 45 minutes
Events 500 pcs.

12.4 Technical Pacemaker Data


Operating Modes • Demand
• Fixed-rate mode
• Overdrive (pulse frequency x 3)

Stimulation pulse
Form Rectangle
Duration 40 ms (20 ms overdrive mode) ± 10%
Pulse rate Configurable in steps of 40...210 beats/min, ± 5%
Pulse current Configurable in the range of 0...150 mA, ± 5%
Art. no.: 0-48-0060 Rev.: a

Signal connection Type CF, defibrillation protected


Readiness for operation Immediately

Page 82
Appendix 13
DEFIGARD 5000 User Guide Accessories DEFIGARD 5000 13.1

13 Appendix
13.1 Accessories DEFIGARD 5000
Defibrillation accessories
Article no. Article description
1-101-3002 Adapter module for internal defibrillation
W1410013 Connection cable for spoon electrodes
W1409505 Spoon electrodes, pediatric, oval 43 x 27 mm - 9 cm2
W1403835 Spoon electrodes, pediatric, round 45 mm - 16 cm2
W1403834 Spoon electrodes, neonatal, 6 cm2
6-34-0005 Spoon electrodes, adult (pkg of 2), 54 cm2
1-101-3000 Paddle cassette
35131 Defibrillation gel (250 ml)
1-101-3001 Adapter module pads
EASY ELEC Adult pads
0-21-0000 Pediatric pads
0-21-0008 Defibrillation paddle adapter for children (x1)

ECG accessories
Article no. Article description
W1402037 10-lead patient cable, clip, 45° plug
W1409608 3-lead patient cable, clip, 45° plug
U50063 4-lead patient cable, clip, 45° plug
W1402262 4-lead patient cable, banana plug, 45° plug
72365 ECG electrodes 34 mm, (x50) for clip cable
72366 ECG electrodes with holding strap, 34 mm, (x50) for ba-
nana plug cable

SpO2 accessories
Article no. Article description
2.100408 Disposable sensor for adults LNOP/ADT (x20)
2.100409 Disposable sensor for children LNOP/ADT (x20)
0-05-0003 SPO2 Masimo extension cable 2.5 m
Art. no.: 0-48-0060 Rev.: a

0-05-0010 SPO2 Masimo extension cable 5 m


0-05-0011 SPO2 Masimo extension cable 10 m
2.100303 SPO2 Masimo finger sensor, adult
2.100305 SPO2 Masimo finger sensor, pediatric

Page 83
13 Appendix
13.1 Accessories DEFIGARD 5000 DEFIGARD 5000

NIBP accessories
Article no. Article description
U50128 Adult cuff 14 cm
U50129 Pediatric cuff 7 cm
W1405268 Air hose 1.5 m
0-22-0001 Air hose 3 m

Pacemaker accessories
Article no. Article description
0-21-0013 Pacemaker/defibrillation pads adult

Various accessories
Article no. Article description
2.300005 Power cable 2P+T, 2.5 m, 90° plug, European standard
W1403916 Connection cable 12 VDC - 30 V
0-50-0000 Paper
2.200132 Additional rechargeable battery Li/ion 10.8V, 4.3 Ah
U50030 Earth cable

Art. no.: 0-48-0060 Rev.: a

Page 84
Appendix 13
DEFIGARD 5000 User Guide Literature 13.2

13.2 Literature
European Resuscitation Council Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular
(2000) Care. Resuscitation 46.

American Heart Association Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular
(2000) Care. Suppl. to Circulation Volume 102 – Number 8.
ISBN 0-87 493-325-0.

Cansell A. (2000) Wirksamkeit und Sicherheit neuer Impulskurvenformen bei transthorakaler Defibrilla-
tion - Biphasische Impulskurvenformen - Notfall & Rettungsmedizin,
Springer Verlag 3 : 458 – 474.

13.3 Glossary
ABCD The primary ABCD
A = Airways (check if airways are free)
B = Breathing (artificial respiration)
C = Circulation (circulatory signs or cardiac massage)
D = Defibrillation

ACLS Advanced Cardivascular Life Support. (ACLS Manual AHA 2001)

AED Automatic external defibrillator

BLS Basic Life Support (artificial respiration and cardiac massage)


CPR is frequently used synonymously

CPR Cardiopulmonary resuscitation

PEA Pulseless electrical activity

VT Ventricular tachycardia

VF Ventricular fibrillation
Art. no.: 0-48-0060 Rev.: a

Page 85
13 Appendix
13.3 Glossary DEFIGARD 5000

Art. no.: 0-48-0060 Rev.: a

Page 86
Index 14
DEFIGARD 5000 User Guide

14 Index
A NIBP softkey............................................... 33
Accessories and disposables ..................... 74
Activating the audio alarm .......................... 25 O
Alarm indicators.......................................... 25 Operating elements .................................... 14
Alarm messages......................................... 25
Operational readiness ................................ 20
Options ....................................................... 13
B
Battery P
Battery life ............................................. 77
Pacemaker
Battery disposal .......................................... 73
Fixed-rate mode (Fix)............................ 54
Battery type ................................................ 77 Pacemaker patients.................................... 28
Biocompatibility........................................... 12
Patient resistance....................................... 80
Physiological alarms................................... 25
C
Charge control and monitoring ................... 80 R
Cleaning ..................................................... 74
Recharging time ......................................... 79
Configurable settings.................................. 13
Cycle time shock - shock............................ 79
S
Safety discharge......................................... 80
D Self-test ...................................................... 72
Danger of electric shock ............................... 6
Semiautomatic defibrillation ....................... 48
Danger of explosion.................................... 18 Shock delivery ............................................ 80
Defibrillation - procedure ............................ 51
Shock successful........................................ 49
Defibrillation pulse ...................................... 79
Shock unsuccessful.................................... 49
Demand mode ............................................ 54 Shockable rhythm................................. 48, 49
SpO2 error messages ................................ 31
E SpO2 Menu ................................................ 31
SPO2 monitoring ........................................ 30
ECG error messages.................................. 29
Standard energy settings ........................... 79
ECG Menu.................................................. 29
ECG, quick diagnosis ................................. 26 Step 2 - analysis......................................... 51
Step 3 - shock delivery ............................... 52
Electrodes - adult and pediatric .................. 42
Step 4 - cardiopulmonary resuscitation ...... 52
Electrodes - apply....................................... 42
Error Detection ........................................... 75 Suppressing an alarm sound...................... 25
Symbols on the device ............................... 10
Event marks................................................ 41
Symbols used on the battery...................... 10
Symbols used on the electrode package ... 11
F Synchronised defibrillation ......................... 46
Functional test ............................................ 72 Synchronised defibrillation using paddles .. 47

I T
Internal defibrillation ................................... 45 Technical alarms ........................................ 25
Terms of Warranty........................................ 8
Threshold values ........................................ 65
L
Art. no.: 0-48-0060 Rev.: a

LEDs........................................................... 16
V
VF/VT detection.......................................... 80
M Voice support ............................................. 50
Maintenance interval .................................. 71
Maintenance interval for the battery ........... 73
Manual defibrillation.................................... 40
Manual defibrillation using paddles ............ 41
Manual defibrillation using pads ................. 42

N
NIBP measuring field.................................. 33
NIBP Menu ................................................. 34

Page 87
14 Index
DEFIGARD 5000

Art. no.: 0-48-0060 Rev.: a

Page 88

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