0-48-0116 NE DG4000 ENG 10.02.10 Rev B

DEFIGARD 4000®
Defibrillator and Monitor

*0-48-0116*
Art. no.: 0-48-0116 Rev.: b
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:
sales@schiller.ch
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: tech.support@schiller.fr
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: sales@schiller.ch
Web: www.schiller.ch
Article no.: 0-48-0116 Rev.: b

Issue date: 08.02.10
S.Art.no.: 2.510759
DEFIGARD 4000 User Guide
Table of Contents
1 Safety Notes .............................................. 1
1.1 Responsibility of the User .................................................. 1
1.2 Intended Use ........................................................................ 1
1.3 Organisational Measures ..................................................... 2
1.4 Safety-Conscious Operation ............................................... 2
1.5 Operation with other Devices .............................................. 3
1.6 Maintenance.......................................................................... 4
1.7 General Safety Notes ........................................................... 4
1.8 Additional Terms .................................................................. 4
1.8.1 Implied authorization .......................................................................... 4
1.8.2 Terms of warranty .............................................................................. 4
1.9 Display Symbols/Indicators................................................. 5
1.9.1 Symbols used in this user guide ........................................................ 5
1.9.2 Symbols used on the device .............................................................. 6
1.9.3 Symbols used on the battery.............................................................. 6
1.9.4 Symbols used on the electrode package ........................................... 7
2 Components and
Operation .................................................. 8
2.1 Design.................................................................................... 8
2.1.1 Standard design and options of the DEFIGARD 4000....................... 9
2.2 Operating Elements............................................................ 10
2.2.1 Front panel ....................................................................................... 10
2.2.2 Back panel ....................................................................................... 11
2.2.3 Paddle operation elements .............................................................. 12
2.2.4 LEDs ................................................................................................ 12
2.2.5 Display ............................................................................................. 13
3 Start-up and Initial Preparation ............. 14

3.1 Mains and Battery Operation............................................. 14
3.1.1 Connecting the unit to the mains and switching it on ....................... 14
3.1.2 Battery operation.............................................................................. 15
3.2 Switching off and Disconnecting from Mains.................. 16
3.2.1 Internal safety discharge .................................................................. 16
3.2.2 Mains supply interruption ................................................................. 16
3.2.3 Ensuring operational readiness........................................................ 16
Art. no.: 0-48-0116 Rev.: b
3.3 Inserting Printing Paper .................................................... 17

3.4 Operation............................................................................. 18
3.4.1 Selecting operational modes............................................................ 18
3.4.2 Accessing the settings via the menu key ......................................... 19
3.4.3 Accessing the alarm threshold settings............................................ 19
4 Monitoring ............................................... 20
4.1 Softkeys, Waveforms and Measurement Fields .............. 20
4.2 Alarm Messages ................................................................. 21
4.3 ECG and Heart Rate Monitoring ........................................ 23
Page 1
DEFIGARD 4000
4.3.1 Quick diagnosis of the ECG using defibrillation electrodes ............. 23

4.3.2 Connecting a 3-lead ECG patient cable........................................... 23
4.3.3 Connecting a 4-lead ECG patient cable........................................... 24
4.3.4 Starting ECG monitoring .................................................................. 25
4.3.5 Monitoring a pacemaker patient....................................................... 25
4.3.6 Alarm thresholds .............................................................................. 26
4.3.7 ECG keys......................................................................................... 26
4.3.8 ECG settings.................................................................................... 26
4.3.9 ECG error messages ....................................................................... 26
4.4 SpO2 Monitoring ................................................................. 27
4.4.1 Starting SpO2 monitoring and test................................................... 27
4.4.2 SpO2 settings .................................................................................. 28
4.4.3 Alarm thresholds .............................................................................. 28
4.4.4 SpO2 error messages...................................................................... 28
5 Defibrillation ............................................29
5.1 Instructions and Safety Notes ........................................... 29
5.1.1 Additional safety information for AED mode .................................... 30
5.1.2 Defibrillating children........................................................................ 30
5.2 General Function ................................................................ 31
5.2.1 Selecting the defibrillation mode ...................................................... 31
5.2.2 Manual defibrillation – procedure..................................................... 31
5.3 Manual Defibrillation Using Paddles................................. 32
5.4 Manual Defibrillation Using Pads...................................... 33
5.4.1 Applying the pads ............................................................................ 33
5.4.2 Checking the electrodes .................................................................. 34
5.4.3 Manual defibrillation using pads – procedure .................................. 34
5.5 Synchronised Defibrillation ............................................... 35
5.5.1 Switching to synchronised defibrillation ........................................... 35
5.5.2 Synchronised defibrillation – procedure........................................... 35
5.6 Semi-Automatic Defibrillation ........................................... 37
5.6.1 Semi-automatic defibrillation (AED) – procedure............................. 37
5.6.2 Defibrillation procedure .................................................................... 40
5.7 Defibrillator Messages ....................................................... 42
6 Pacemaker ...............................................43
6.1 Pacemaker Function........................................................... 43
6.1.1 Fixed-rate mode (Fix)....................................................................... 43
6.1.2 Demand mode ................................................................................. 43
6.1.3 Overdrive mode ............................................................................... 43
6.2 Safety Notes ........................................................................ 44
6.3 Guidelines for the Application of External Pacemakers . 44
Art. no.: 0-48-0116 Rev.: b
6.3.1 Attaching the pacer pads ................................................................. 45

6.4 Start-up of the Pacemaker ................................................. 46
6.4.1 Selecting pacemaker mode ............................................................. 46
6.4.2 Pacemaker settings for fix mode...................................................... 46
6.4.3 Demand mode ................................................................................. 47
6.4.4 Overdrive mode ............................................................................... 47
7 Finishing the Therapy ............................48

7.1 Finishing procedure ........................................................... 48
Page 2
8 Intervention Summary ........................... 49

8.1 Printing Curves and Measured Values ............................. 50
8.1.1 Example of a defibrillator shock printout .......................................... 50
8.1.2 Printer error messages..................................................................... 50
9 Device Configuration ............................. 51

9.1 Menu Options...................................................................... 51
9.2 Device .................................................................................. 52
9.2.1 Standard thresholds ......................................................................... 52
9.2.2 Releases .......................................................................................... 52
9.2.3 Sounds/screen ................................................................................. 52
9.2.4 Date/time.......................................................................................... 53
9.2.5 Reserved SCHILLER ....................................................................... 53
9.2.6 Language ......................................................................................... 53
9.2.7 Serial number................................................................................... 53
9.3 ECG/Defi Menu.................................................................... 54
9.4 Alarms ................................................................................. 54
9.5 Printer .................................................................................. 54
9.6 Download ............................................................................ 54
10 Maintenance ............................................ 55
10.1 Maintenance Intervals ........................................................ 55
10.1.1 Visual unit check .............................................................................. 55
10.1.2 Functional test.................................................................................. 56
10.2 Disposal Information .......................................................... 57
10.2.1 Battery disposal................................................................................ 57
10.2.2 Disposal of accessories that come into contact with the patient ...... 57
10.2.3 Disposal at the end of the device's useful life .................................. 57
10.3 Cleaning .............................................................................. 58
10.3.1 Cleaning the casing.......................................................................... 58
10.3.2 Accessories and disposables........................................................... 58
10.4 Error Detection ................................................................... 59
10.4.1 General errors .................................................................................. 59
10.4.2 Technical error messages................................................................ 59
10.4.3 Measures to prevent electromagnetic interferences ........................ 60
11 Technical Data ........................................ 61

11.1 System Data ........................................................................ 61
11.2 Classification and Safety Standards ................................ 62
Art. no.: 0-48-0116 Rev.: b
11.3 Defibrillation Pulse ............................................................. 63

11.4 Technical Data – Measured Values ................................... 65
11.4.1 ECG ................................................................................................. 65
11.4.2 SpO2 – pulsoximetry........................................................................ 65
11.4.3 Storage of intervention (option)........................................................ 66
11.5 Technical Pacemaker Data ................................................ 66
12 Appendix ................................................. 67
12.1 Accessories DEFIGARD 4000............................................ 67
12.2 Literature ............................................................................. 69
12.3 Glossary .............................................................................. 69
Page 3
DEFIGARD 4000
12.4 Inspection Report ............................................................... 70
13 Index ........................................................71
Art. no.: 0-48-0116 Rev.: b
Page 4
Safety Notes 1
DEFIGARD 4000 User Guide Responsibility of the User 1.1
1 Safety Notes
1.1 Responsibility of the User
 The device must only be used by qualified physicians or other persons (only
AED mode) trained in early defibrillation.
 The numerical and graphical results and any interpretation given must be exam-
ined with respect to the overall clinical condition of the patient and the general
recorded data quality.
 The indications given by this equipment are not a substitute for regular checking
of vital functions.
 Make sure that the user has read and understood the user guide, and especially
these safety notes.
 Damaged or missing components must be replaced immediately.
 It is the owner's responsibility that the valid regulations for safety and prevention
of accidents are observed.
 The device must be stored inaccessible to children.
 Properly dispose of the package material and make sure it is out of children's
reach.
1.2 Intended Use

 The DEFIGARD® 4000 is a defibrillator used for the treatment of ventricular fi-
brillation (VF) and ventricular tachycardia (VT). The device can also be used as
a pacemaker. The monitoring function of the DEFIGARD® 4000 gives the most
important parameters – ECG, SpO2 and NIBP – and allows continuous monitor-
ing of the patient from the beginning to the end of an intervention.
 The device is only intended for single patient use.
 The defibrillator must only be used if the following symptoms are found:
– non-responsive
– no respiration
– no pulse
 The defibrillator must not be used in semi-automatic mode (AED) when the per-
son:
– is responsive or
– is breathing or
– has pulse
 The DEFIGARD® 4000 is an emergency device that must be ready for use at
any time and in any situation. If no mains is available, make sure that the battery
charge is sufficient.
Art. no.: 0-48-0116 Rev.: b
 Only operate the device in accordance with the specified technical data.
 Do not use this unit in areas where there is any danger of explosion or in the
presence of flammable gases such as anaesthetic agents.
Page 1
1 Safety Notes
1.3 Organisational Measures DEFIGARD 4000
1.3 Organisational Measures

 Before using the unit, ensure that an introduction regarding the unit functions
and the safety precautions has been provided and understood.
 Always store the user guide handy near the device. Make sure that they are al-
ways complete and legible.
 These operating instructions do not override any statutory or local regulations,
or procedures for the prevention of accidents and environmental protection.
1.4 Safety-Conscious Operation

 This user guide, and especially these safety notes, must be read and observed.
 Danger of electric shock!
The energy applied to the patient can be conducted through the patient to other
persons, who may suffer a lethal electric shock. Therefore:
– Do not touch the patient, the electrodes or other conducting objects during de-
fibrillation
– Do not defibrillate the patient in a puddle of water or on other conductive surfac-
es
– Switch the device off when it is no longer used.
 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. 2.2
on page 11), even if these are earthed.
 Immediately report any changes that impair safety (including operating behav-
iour) to the person responsible.
 Only connect original SCHILLER accessories to the device.
 Before switching on, check if the unit's casing and electrode connection are un-
damaged.
 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.
 Special caution must always be taken on intracardiac application of medical
equipment. Especially make sure that no conducting parts connected to the
unit's isolated patient input (patient, plug, electrodes, sensor) come into contact
with other, earthed conductive objects, as this might short-out the patient's iso-
lation and remove the protection of the isolated input.
 Position the device so that there is no possibility of it falling on the patient or floor. Art. no.: 0-48-0116 Rev.: b
Page 2
Safety Notes 1
DEFIGARD 4000 User Guide Operation with other Devices 1.5
1.5 Operation with other Devices

 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.
 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 4000
For this reason, devices that are not required should be disconnected from the pa-
tient, and only equipment approved by SCHILLER may be connected to the
DEFIGARD 4000.
 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.
 Magnetic and electrical fields from X-ray or tomographic devices, portable radio
equipment, HF radios and devices labelled with the symbol can affect the
operation of this device. (See section 10.4.3.) Avoid using such devices or keep
a sufficient distance from them.
 The charging of energy and the release of the defibrillation impulse can disturb
other devices. Check these devices before their further use.
 Sensors and devices that are not defibrillation proof must be disconnected from
the patient before a shock is triggered.
 If the patient has a pacemaker implanted, do not position the electrode directly
onto the pacemaker. Check the pacemaker after the defibrillation.
 The DEFIGARD® 4000 can be used together with high-frequency electrosurgi-
cal devices. However, precautions must be observed when such HF equipment
is used. To reduce the risk of burns in the case of a failure of the neutral HF elec-
trode, 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.
Art. no.: 0-48-0116 Rev.: b
Page 3
1 Safety Notes
1.6 Maintenance DEFIGARD 4000
1.6 Maintenance
 Danger of electric shock! Do not open the device. No serviceable parts inside.
Refer servicing to qualified personnel only.
 Switch the device off before cleaning.
 Do not use high temperature sterilisation processes (such as autoclaving). Do
not use E-beam or gamma radiation sterilisation.
 Do not use solvent or abrasive cleaners on either the unit or cable assemblies.
 Do not, under any circumstances, immerse the unit or cable assemblies in liquid.
1.7 General Safety Notes

 Operating a device with a defective casing or defective cables constitutes a dan-
ger to the patient or the user! Therefore:
– Immediately replace a damaged unit, or damaged cables and connections.
1.8 Additional Terms

1.8.1 Implied authorization
Possession or purchase of this device does not convey any express or implied license
to use the device with replacement parts which would alone, or in combination with
this device, fall within the scope of one or more patents relating to this device.
1.8.2 Terms of warranty

Your SCHILLER DEFIGARD 4000 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 authorised by him, and
• the DEFIGARD 4000 and approved attached equipment is used in accordance
with the manufacturer's instructions
Art. no.: 0-48-0116 Rev.: b
There are no express or implied warranties which extend beyond the warranties here-
inabove set forth. SCHILLER makes no warranty of merchantability or fitness for a
particular purpose with respect to the product or parts thereof.
Page 4
Safety Notes 1
DEFIGARD 4000 User Guide Display Symbols/Indicators 1.9
1.9 Display Symbols/Indicators

1.9.1 Symbols used in this user guide
The safety level is classified according ANSI Z535.4. The following overview shows
the safety symbols and pictograms used in this user guide.
For a direct danger which could lead to severe personal injury or to death.
For a possibly dangerous situation, which could lead to serious bodily injury or to
death.
For a possibly dangerous situation which could lead to personal injury. This symbol
is also used to indicate possible damage to property.
For general safety notes as listed in this section.
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.: 0-48-0116 Rev.: b
Page 5
1 Safety Notes
1.9 Display Symbols/Indicators DEFIGARD 4000
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 of the CE certification (LNE/G-MED)
Note accompanying documents!
SCHILLER potential equalisation.
Symbol for the recognition of electrical and electronic equipment.
This unit must be disposed of in a municipally approved collection point or recycling

centre.
Improper disposal harms the environment and human health due to the presence of
dangerous substances in electrical and electronic equipment.
1.9.3 Symbols used on the battery
The unit/component can be recycled.
Battery may not be disposed of with domestic refuse.
Battery may not be burned.
Art. no.: 0-48-0116 Rev.: b
Page 6
Safety Notes 1
DEFIGARD 4000 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.: 0-48-0116 Rev.: b
Page 7
2 Components and Operation
2.1 Design DEFIGARD 4000
2 Components and
Operation
The DEFIGARD® 4000 is a lightweight mains and battery powered defibrillator fea-
turing an ECG monitor, a recorder, SpO2 measurement, and a transcutaneous pace-
maker. It is designed for clinical use. Defibrillation is possible in non-synchronised or
synchronised mode.
Moreover, the device can be switched to automatic defibrillation (AED operation) via
a rotary switch.
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® 4000 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

• 3.5 hours monitoring
Defibrillator The DEFIGARD® 4000 is a defibrillator featuring biphasic pulsed defibrillation im-
pulse – Multipulse Biowave®. The patient is defibrillated via paddles or disposable
adhesive electrodes (pads), which also acquire the ECG signal for analysis. Adhesive
electrodes for children and adults are available. The device recognises the connected
electrodes and selects the defibrillation energy levels accordingly. In the AED mode,
the user will be given visual and audible instructions (display/loudspeaker).
External cardiac pacemaker The DEFIGARD® 4000 pacemaker function can at any time be activated via the ad-
hesive electrodes. The fix and demand modes can be selected by turning the rotary
switch.
Monitoring The DEFIGARD® 4000 monitoring function gives all important parameters – ECG
and SpO2. The parameters are indicated in figures and as waveforms on the large
LCD display.
Art. no.: 0-48-0116 Rev.: b
Data storage The ECG and trends are saved in the device. Three ECG curves can be printed on
the integrated printer:
Data transmission • Easy transmission of a 3-lead ECG via GSM

• USB interface, e.g. for a USB stick for the copying of data or software updates.
Page 8
Components and Operation 2
DEFIGARD 4000 User Guide Design 2.1
2.1.1 Standard design and options of the DEFIGARD 4000

The standard design of the DEFIGARD 4000 consists of:
•
External biphasic defibrillator with
– Paddles or adhesive electrodes
– Manual operational mode with synchronous mode
– 3-lead patient cable
The following table shows the available options.
Options Paddles Adhesive elec-

trodes
AED mode X
SpO2 X X
Pacemaker X X
4-lead patient cable X X
Printer X X
Modem X X
Keyboard types
With paddles (charging and shock

With adhesive elec- With adhesive electrodes release via paddles)
trodes and AED mode and manual mode
AED mode Manual Manual

mode mode
Art. no.: 0-48-0116 Rev.: b
• AED mode • Manual mode • Manual mode

• Pacemaker • Pacemaker • Pacemaker
Page 9
2.2 Operating Elements DEFIGARD 4000
2.2 Operating Elements

2.2.1 Front panel
Rotary switch:
Swing-out carrying handle • On/off

• Monitoring
• Defibrillator energy selec
tion
• Pacemaker
• AED defibrillator
LED for charging
and mains oper-
ation
LCD Analysing/
charging button
Printer
Shock
key
Programming
buttons Pads connection
Paddles con-
nection
ECG patient cable SpO2 connection Loudspeaker

connection Function keys:
• Menu access
• Alarm settings
Art. no.: 0-48-0116 Rev.: b
• Alarm confirmation
Fig. 2.1 Control elements at the front panel of the DEFIGARD 4000
Page 10
DEFIGARD 4000 User Guide Operating Elements 2.2
2.2.2 Back panel
6c
6b
6a
6 2
5 4 3
Fig. 2.2 Control elements at the back panel of the DEFIGARD 4000
(1) Carrying handle

(2) Potential equalisation
(3) Mains connector
(4) Fuses
(5) Battery housing
(6) Connections for:
– (6a) RS-232 interface
– (6b) USB interface for the copying of data or software installations
– (6c) SIM card slot
Art. no.: 0-48-0116 Rev.: b
 The plug-in connections are only designed for the connection of equipment or
accessories supplied by SCHILLER.
Page 11
2.2 Operating Elements DEFIGARD 4000
2.2.3 Paddle operation elements
Keys for energy charging and release

of the defibrillation impulse
Fig. 2.3 Paddles operation elements
2.2.4 LEDs
The LEDs give the following information:
(1) Flashes while the battery is being charged and is extinguished when the battery
1 2 is full
(2) Unit connected to the mains
Fig. 2.4 LED indicator

Art. no.: 0-48-0116 Rev.: b
Page 12
DEFIGARD 4000 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.
Synchronous pulse
ECG waveform
field Heart rate meas-
urement field
ECG calibration
impulse 1 mV
ECG alarm mes- HR ECG

sages
SpO2 waveform SpO2 measurement

field field
System and SpO2

alarm messages
Display field defibrillator operation Data transfer indication

Alarm delayed or off
Battery charge status/mains supply
Remaining alarm suppression time or alarm
off
Alarm Type Indicators
Function keys displayed in monitoring mode

Alarm active
Alarm delayed
ECG amplitude ECG leads Start printer More func-

0.25/0.5/1/2 tion keys At least one audible alarm is switched
cm/mV off
Art. no.: 0-48-0116 Rev.: b
Alarms permanently off
Fig. 2.5 Display elements of the DEFIGARD 4000
Page 13
3 Start-up and Initial Preparation
3.1 Mains and Battery Operation DEFIGARD 4000
3 Start-up and Initial Prepara-

tion
 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.
 Please read the safety notes in section 1 before initial operation.
 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 anaesthetics. Oxygenation in the vicinity of the defibrillation electrodes
must be strictly avoided.
 Danger of electrical shock. The DEFIGARD® 4000 is a high-voltage therapy de-
vice. Improper use of the device can endanger life. Always follow the instructions
given in this user guide.
 The user must make sure that there are no conductive connections between the
patient and other persons during ECG analysis and defibrillation.
 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 (1) and to the mains (100–240 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. Turn the rotary switch from position to the required operational mode.
4. Check the settings according to section Device Configuration on page 51.
5. Connect the other needed cables.
1 2
Fig. 3.1 Connections

Art. no.: 0-48-0116 Rev.: b
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 14
Start-up and Initial Preparation 3
DEFIGARD 4000 User Guide Mains and Battery Operation 3.1
3.1.2 Battery operation

Charging the battery
Important
The internal battery is automatically charged when the device is connected to the
mains. It requires approx. 16 hours to be 80% recharged.
1
The recharging of the battery is indicated by the LED above the battery symbol.
– LED (1) flashes while the battery is being recharged.

– LED (1) is extinguished when the battery is full.
– The battery symbol is displayed in the status bar.
Fig. 3.2 LED battery operation
Battery Low Indication

Full
When the battery is low, a flashing battery symbol is displayed at the bottom of the
screen.
Empty Full battery indication

When the battery is full, the full battery symbol is displayed at the bottom of the screen.
Fig. 3.3 Battery indication

Art. no.: 0-48-0116 Rev.: b
Page 15
3.2 Switching off and Disconnecting from Mains DEFIGARD 4000
3.2 Switching off and Disconnecting from Mains
1. Turn the rotary switch to position .

2. 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® 4000 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. An internal discharge will take place 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...40 °C. Lower ambient tem-
peratures impair the battery.
To ensure its readiness for use, the device runs a self-test. The self-test is run:
• when the device is turned on

• Weekly test on Sunday around midday.
If the device detects an error during the self-test, an error message is displayed.
Art. no.: 0-48-0116 Rev.: b
Page 16
DEFIGARD 4000 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 vapours.
Therefore, store the paper in a cool and dry area and not in a plastic wrap.
1. Press the locking catch (1) to the front. The paper tray is unlocked.
2. Pull the paper tray out.
3. Insert paper and pull it up. Make sure that the paper mark (2) faces to the top of
the unit.
4. Reinsert the paper tray and close it. Be sure that the paper lies exactly between
the rails (3).
1
3
Art. no.: 0-48-0116 Rev.: b
Page 17
3.4 Operation DEFIGARD 4000
3.4 Operation
Depending on the variant of the device, some of the operational modes may not be
available.
3.4.1 Selecting operational modes

The following operational modes can be selected in the DEFIGARD 4000:
(1) Unit off

(2) Monitoring
(3) AED defibrillation
(4) Demand pacemaker
(5) Fix pacemaker
(6) Manual defibrillation/energy selection
5
1
4
2 3
Fig. 3.4 Operational modes on the rotary switch
Direct keys
Direct key for the display of more function keys or configuration menu access
Art. no.: 0-48-0116 Rev.: b
Direct key to access the alarm threshold menu
Direct key to confirm/delete alarms
Page 18
DEFIGARD 4000 User Guide Operation 3.4
3.4.2 Accessing the settings via the menu key

1. Keep the menu key pressed during unit switch-on. The main menu is displayed:
2. Select, display and edit the menu using the function keys.
3. Switch the device off to exit the menu.
Options
Device
ECG/Defi
Alarms
Printer
Download
3.4.3 Accessing the alarm threshold settings

The threshold values can be changed either via the different menus or directly via the
threshold menu key.
1. Press alarm threshold key.

3. Exit the menu by pressing Back.
Thresholds Adult Default
ECG HR 60 135 p/min

SpO2 PULS 90 165 p/min
% 90 97 %
Art. no.: 0-48-0116 Rev.: b
Page 19
4 Monitoring
4.1 Softkeys, Waveforms and Measurement Fields DEFIGARD 4000
4 Monitoring
The operation and menu access are detailed on page 18.
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 at the bottom of the display. The
functions of these keys vary according to the selected waveform field.
These softkeys are displayed when the MENU key is pressed.
Settings
The settings that are defined via the softkeys or menus remain saved when the unit
Art. no.: 0-48-0116 Rev.: b
is switched off and will automatically be active when it is switched on again.
Page 20
Monitoring 4
DEFIGARD 4000 User Guide Alarm Messages 4.2
4.2 Alarm Messages

4 3 Physiological alarms
When a measurement reading exceeds an alarm limit, an alarm is triggered after 3
seconds and
• the measurement reading 3 flashes

• an interrupted alarm sounds (4 beeps/sec)
Technical alarms
When a technical error occurs:
• An error message is displayed at the bottom of the alarm field

• an interrupted alarm sounds (2 beeps/sec)
• A question mark is displayed instead of the measurement reading (4)
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.
1 2
5
Suppressing an alarm sound
Fig. 4.1 Alarm indicators
Suppress the alarm by pressing the button (5):
• If you press the button briefly, it remains suppressed for 2 min and the symbol (1)
is replaced by the remaining time in minutes.
• 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 until it returns to the normal range.
Activating the alarm sound

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 54, section 9.3.)
Art. no.: 0-48-0116 Rev.: b
Page 21
4 Monitoring
4.2 Alarm Messages DEFIGARD 4000
Alarm Symbols (2)
Alarm active
Alarms suppressed for 2 minutes. This symbol is displayed when the alarm suppres-
sion key (5) is pressed.
At least one threshold alarm is switched off (except min. HR and min. pulse SpO2).
This symbol is displayed 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 sec, but only if the alarm settings in the device settings menu are per-
manently Yes. (See page 54, section 9.4.)
Art. no.: 0-48-0116 Rev.: b
Page 22
Monitoring 4
DEFIGARD 4000 User Guide ECG and Heart Rate Monitoring 4.3
4.3 ECG and Heart Rate Monitoring

 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.
 Danger of destroying the device during defibrillation! The device is only type CF
protected if the original SCHILLER patient cables are used.
 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 defibrillation
electrodes (lead designation "DEFI").
Fig. 4.2 Defibrillation electrodes
4.3.2 Connecting a 3-lead ECG patient cable

When the ECG is recorded using a 3-lead patient cable and no other parameter is ac-
tive, the ECG is only shown in one channel with lead II.
Red Yellow
Green
Fig. 4.3 3-lead cable

Art. no.: 0-48-0116 Rev.: b
Page 23
4 Monitoring
4.3 ECG and Heart Rate Monitoring DEFIGARD 4000
4.3.3 Connecting a 4-lead ECG patient cable
Red Yellow
When the ECG is recorded using a 4-lead patient cable and no other parameter is ac-
tive, the ECG is shown in two channels with lead II.
Green
Black
Fig. 4.4 4-lead cable
Art. no.: 0-48-0116 Rev.: b
Page 24
Monitoring 4
DEFIGARD 4000 User Guide ECG and Heart Rate Monitoring 4.3
4.3.4 Starting ECG monitoring

1. Apply the electrodes as shown in Fig. 4.3 or Fig. 4.4.
2. Connect the patient cable to the ECG signal input.
3. Define the ECG settings directly via the softkeys.
4. Press the alarm threshold key and check the settings.
Display of leads Amplitude

I...aVF 0.25, 0.5, 1, 2 cm/mV
Fig. 4.5 ECG softkeys
4.3.5 Monitoring a pacemaker patient
 Erroneous HR readout In the monitoring of pacemaker patients, we cannot

exclude 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® 4000 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 situ-
ation 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 a flashing S in the ECG win-
dow.
 To switch, press MENU/more function keys and then softkey .

Art. no.: 0-48-0116 Rev.: b
Fig. 4.6 Indication HR source SpO2
Page 25
4 Monitoring
4.3 ECG and Heart Rate Monitoring DEFIGARD 4000
4.3.6 Alarm thresholds

Menu Parameter Min. Max. Unit
ECG HR adult 50 130 p/min
HR paediatric 50 130 p/min
4.3.7 ECG keys

Key Description Value
Preselection of the standard waveform

DEFI / I, II, III
groups that should be displayed.
ECG amplitude setting. 0.25 / 0.5 / 1 / 2 cm/mV
Heart or S
aSource
based on which the heart rate
should be determined
a. When the patient has a cardiac pacemaker, the HR source must be set to SpO2 (see page 25).
4.3.8 ECG settings

The display of the second ECG curve is set in the ECG/Defi menu (see page 54).
4.3.9 ECG error messages

Alarm Cause Remedy
• Electrodes not attached to the pa-  Check the contact between the electrodes and the pa-
tient; come off; bad contact tient.
CONNECT THE ELEC- • Electrodes defective; line break
TRODES! • The device is defective
 Check the ECG cable and electrodes
 Have the device repaired
• Ventricular fibrillation or tachycar-  Physiological alarm!
FIBRILLATION dia with a rate exceeding 180 p/
min
Art. no.: 0-48-0116 Rev.: b
Page 26
Monitoring 4
DEFIGARD 4000 User Guide SpO2 Monitoring 4.4
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 maximally 2 minutes.
 Only use sensors listed in the order information for SpO2 measurement with the
DEFIGARD® 4000. Other oxygen transducers (sensors) may lead to improper
performance.
 The information in this user guide does not overrule the instructions given in the
user guide of the sensor, which must also be observed.
 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.
 Before using the sensor, carefully read the sensor directions for use.
 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.
 Do not use damaged patient cables, damaged sensors or a sensor with exposed
optical components.
 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.
 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.
 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.: 0-48-0116 Rev.: b
1. Apply the SpO2 sensor to the patient. Insert the patient's forefinger into the probe
Good perfusion 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.
Bad perfusion
Fig. 4.7 SpO2 measurement field
Page 27
4 Monitoring
4.4 SpO2 Monitoring DEFIGARD 4000
4.4.2 SpO2 settings

These settings are defined in the Options menu (see page 51).
Menu Parameter Description Value

SpO2 SpO2 curve Display of the SpO2 curve Yes/No
Definition of the integration time for the cal-
SpO2 average time 8/16 seconds
culation of the displayed average value
4.4.3 Alarm thresholds

Menu Parameter Min. Max. Unit
% 85 100 %
4.4.4 SpO2 error messages

Alarm Cause Remedy
• Weak pulse  Check the sensor and reapply
Low perfusion
• Bad sensor positioning
TOO MUCH LIGHT! • Sensor is disturbed by ambient light  Reduce ambient light
CAPTOR PROBLEM! • Sensor failed  Replace the sensor
• Measurement disturbed by external influ-  Patient must not move
ARTEFACTS!
ences
• Sensor not connected to the patient or  Check the contact between the sensor and the
SENSOR OFF PATIENT!
lose patient
• Device is searching for the pulse  Make sure that the sensor is well connected to
SEARCH PULSE!
the patient
CAPTOR PROBLEM! • Wrong or defective sensor  Replace the sensor
NO CAPTOR! • SpO2 sensor failed or disconnected  Replace the sensor
Art. no.: 0-48-0116 Rev.: b
Page 28
Defibrillation 5
DEFIGARD 4000 User Guide Instructions and Safety Notes 5.1
5 Defibrillation
5.1 Instructions 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.
 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.
 Do not allow the defibrillation electrodes to come into contact with other elec-
trodes or metal parts which are in contact with the patient.
 The patient's chest must be dry, as moisture causes unwanted pathways for the
defibrillation current. For safety, wipe off flammable skin cleansing agents.
 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:
– Sternum, clavicle or
– mamillas
 The selected energy and the patient's condition are decisive factors for the suc-
cess of the defibrillation. The physician is responsible for the selection of the re-
quired energy, except in the AED mode, where generally accepted values are
set (AHA/ERC).
 Immediately prior to the shock, the heart massage (CPR) and artificial respira-
tion must be stopped and bystanders must be warned.
 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.
 Equipment damage! Sensors and devices that are not defibrillation proof must
be disconnected from the patient before a shock is triggered.
 The success of the defibrillation depends on the correct application of the defi-
brillator but also the heart's condition. It is the physician's responsibility to decide
about any additional measures (e.g. adrenaline).
Art. no.: 0-48-0116 Rev.: b
Page 29
5 Defibrillation
5.1 Instructions and Safety Notes DEFIGARD 4000
5.1.1 Additional safety information for AED mode

In addition to the guidelines set forth in section 5.1, the following rules must be ob-
served when using an AED, as failure to do so may compromise the success of the
defibrillation or endanger the patient's life.
 The user is committed to verify the prerequisites for the use of the AED by check-
ing for lack of consciousness, lack of breathing and lack of circulatory signs us-
ing the ABCD system (BLS algorithm).
 The device must only be used if the following symptoms are found:
– non-responsive
– no respiration
– no pulse
 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.
 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.
 If the ECG signal changes such that the shock is not recommended, the shock
delivery is automatically blocked.
5.1.2 Defibrillating children
 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.
 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.: 0-48-0116 Rev.: b
Page 30
Defibrillation 5
DEFIGARD 4000 User Guide General Function 5.2
5.2 General Function

• The DEFIGARD® 4000 works with biphasic pulsed defibrillation impulse. De-
pending on the factory settings, the device either switches automatically from syn-
chronised to non-synchronised 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.
• 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 Selecting the defibrillation mode

The manual or automatic AED defibrillation modes are selected using the rotary
switch.
5.2.2 Manual defibrillation – procedure

1. Select the required energy using the rotary switch.
2. The set energy is displayed on the screen.
3. Charge the energy, depending on the device type via one of the paddles' charging
buttons or the ANALYSE CHARGE key on the device (2).
4. Trigger the shock by pressing both red charging/triggering buttons on the paddles
or the shock key (3).
Fig. 5.1 Defibrillator window

Art. no.: 0-48-0116 Rev.: b
Page 31
5 Defibrillation
5.3 Manual Defibrillation Using Paddles DEFIGARD 4000
5.3 Manual Defibrillation Using Paddles

 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
section 5.1.
• 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. Select the required energy via the rotary switch.

2. Take the electrodes from the accessory bag.
3. Carefully dry the paddles and the handles in particular, if they are wet.
4. Apply an ample amount of electrode cream to the paddle surfaces.
5. 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
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.
After delivery of the shock, the audio signal stops and the recorder starts (if con-
figured).
11. Monitor the patient's ECG.
12. After the therapy, turn the energy selection button back to "0".
13. The monitoring of the patient can be continued on position .
14. Finish the therapy. (See page 48.)
Fig. 5.2 Paddle application

Art. no.: 0-48-0116 Rev.: b
Page 32
Defibrillation 5
DEFIGARD 4000 User Guide Manual Defibrillation Using Pads 5.4
5.4 Manual Defibrillation Using Pads

sections 5.1 and 5.2.
 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
 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.
 The pads are pre-gelled, so there is no need to use extra contact agent.
 Do not reuse the pads.
Adult and pediatric electrodes
Large electrodes The large electrodes are to be used for adults and children from 25 kg body weight.
Small electrodes The small electrodes are intended for children with a body weight under 25 kg.
Applying the electrodes
 Good contact between the skin and the adhesive electrodes must be ensured.
Suntan oil, sand or salt reduce the adhesive quality.
 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. 5.3). 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 below the left breast as illustrated in Fig. 5.3.
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.: 0-48-0116 Rev.: b
Fig. 5.3 Electrode application points
Page 33
5 Defibrillation
5.4 Manual Defibrillation Using Pads DEFIGARD 4000
5.4.2 Checking the electrodes

If the resistance between the skin and the electrodes 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 both application areas to remove the uppermost layer of skin.
5. apply new defibrillation pads to these points
5.4.3 Manual defibrillation using pads – procedure

1. Plug in the electrode cable.
2. Select the energy using the rotary switch (1).

3. Charge the energy by pressing the ANALYSE/CHARGE function key (2).
1
2
• Do not, under any circumstances, touch the patient during shock delivery.
3
• Make sure that the patient does not touch any conducting objects.
4. Trigger the shock by pressing the key (3).
Art. no.: 0-48-0116 Rev.: b
Fig. 5.4 Manual defibrillation using adhe-

sive electrodes
Page 34
Defibrillation 5
DEFIGARD 4000 User Guide Synchronised Defibrillation 5.5
5.5 Synchronised Defibrillation

 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.
 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.
 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 under trigger pulses are positioned exactly below the R-wave
5.5.1 Switching to synchronised defibrillation
The mode can be changed manually or automatically.
1. Select the energy via the rotary switch.

Synchronous pulse
2. Press the MENU key. The Sync key appears.
3. Select synchronised defibrillation by pressing the SYNC key. The setting is con-
firmed by synchronous impulses on the ECG.
Triggering the shock
The shock key must be pressed until the actual shock has been released.
Fig. 5.5 Switching to/display of synchro-

nised defibrillation
Art. no.: 0-48-0116 Rev.: b
5.5.2 Synchronised defibrillation – procedure
 The shock key must be pressed until the actual shock has been released.
 The automatic switch-over to the synchronous mode can result in a delayed
shock, as an artefact can be falsely detected as a QRS complex. This function
does not comply with the IEC 60601-2-4 standard but has been maintained an-
yway on express request of the users, who do not agree with the standard.
Page 35
5 Defibrillation
5.5 Synchronised Defibrillation DEFIGARD 4000
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 defi-
brillation 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)).
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 54, section 9.3).
When the switchover is automatic, the DEFIGARD® 4000 switches to the synchro-
nised mode when it detects a QRS complex. If no QRS complex is detected for more
than 3 seconds, the message SYNCHRO is replaced by END SYNC and an audible sig-
nal sounds. After 3 more seconds, the device switches from SYNCHRO to DIRECT de-
fibrillation.
In devices with manual switch-over, the mode is switched by pressing the softkey
SYNC (2). However, if the device does not detect a QRS complex in the synchronised
2
mode, the shock will be delivered directly after 6 seconds. We recommend performing
synchronised defibrillation with pads and at the same time acquiring the ECG signal
via the pads. As an alternative, the ECG can be acquired with ECG electrodes. You
Fig. 5.6 Synchronised defibrillation
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 with Paddles – No) or if
the recording can be done using either separate ECG electrodes or the paddles (Syn-
chro with Paddles – Yes). Defibrillation with pads is described on page 33; defibril-
lation with paddles on page 32, and the application of ECG electrodes on page 33.
Check that with each QRS complex
• the QRS beep sounds

• the trigger marks (1 – Fig. 5.6) and the "QRS blip" appear
Please note that when you trigger the shock, it is only released after the next control-
ling impulse by the ECG. Therefore, the shock key must be kept pressed until the ac-
tual shock release.
Art. no.: 0-48-0116 Rev.: b
Page 36
Defibrillation 5
DEFIGARD 4000 User Guide Semi-Automatic Defibrillation 5.6
5.6 Semi-Automatic Defibrillation

sections 5.1 and page 5.1.130.
 According to AHA guidelines, only children from 1 year old may be defibrillated
in semi-automatic mode.
 In the semi-automatic mode, the electrodes should be applied in the common
anterior-anterior positions. With infants, anterior-posterior placement can be ad-
vised to prevent a short-circuit between the two defibrillation electrodes.
 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.
 During HF surgical interventions, ECG analysis is not permitted in the semi-au-
tomatic mode.
5.6.1 Semi-automatic defibrillation (AED) – procedure
In the AED operational mode, all other modules are stopped.
The user is guided through all operation steps by spoken and displayed instructions.
The AED mode is selected using the rotary switch (1).
1 When the analysis key (2) 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
2 is advised to stay clear of the patient. The analysis takes approximately 10 seconds.
Device identifies 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 (3). Shockable rhythms are:
• Ventricular fibrillation
• Ventricular tachycardia with a rate exceeding 180 p/min
Art. no.: 0-48-0116 Rev.: b
Page 37
5 Defibrillation
5.6 Semi-Automatic Defibrillation DEFIGARD 4000
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.
First shock After the shock, the user is prompted to:
1. alternately carry out 30 1chest compressions and give 2 breaths for 2 minutes.
2. after 2 minutes, the unit prompts the user again to start a new ECG analysis. De-
pending on the configuration, this new analysis may start automatically.
If shock unsuccessful: Second shock release and prompt to restart with step 1.
If 2shock successful: Information that no shock is required and
• prompt to carry out cardiac compressions and respiration alternately for 2 minutes
until the patient breathes or new instructions follow.
• after 2 minutes, prompt to start a new ECG analysis
Device detects no shockable rhythm If the analysis program does not detect a shockable rhythm, the device informs the
user about the further steps:
• that no shock is required

• that he or she should alternately carry out 30 chest compressions and 2 breaths
for 2 minutes
• after 2 minutes, prompt to start a new ECG analysis
Art. no.: 0-48-0116 Rev.: b
1. When paediatric electrodes are used, CPR is carried out in the rhythm 15:2 if 2 rescuers are
on the spot, otherwise in the 30:2 rhythm.
2. CPR should be continued even after a successful shock to reduce the risk of momentary
electrical myocardial stunning after the defibrillation.
Page 38
Defibrillation 5
Voice support in AED mode

The device carries out a self-test on switch-on. The following instructions will be spo-
ken by the device:
Language Display Note

• PLACE ON ELEC- Technical alarm:
Place electrodes on chest and plug into TRODES!
Electrodes not yet applied. The message disap-
machine. • PLUG INTO MACHINE pears as soon as the electrodes are correctly ap-
plied and the resistance is below 250 Ohm.
Technical alarm:
Poor connection; press the electrodes CHECK THE ELECTRODES The contact between the electrodes and the skin
is not sufficient. The patient resistance is in the
range of 250 to 400 ohms.
Press blue analysis button. PRESS ANALYSIS BUTTON Heart rhythm analysis is started.
DO NOT TOUCH THE PA-
Do not touch the patient. Analysis in
TIENT
progress.
ANALYSING
Movement detected MOVEMENT DETECTED Technical alarm: Patient was moved during anal-
Stand clear STAND CLEAR ysis and device could not run analysis.
Device recommends a shock
DO NOT TOUCH THE PA-
Do not touch the patient. Charging. TIENT
CHARGING
Stand clear of patient; press orange but-

ton PRESS ORANGE BUTTON
TO SHOCK
Device does not recommend a shock
No shock advised. No shock advised.
Immediately resume CPR: 30 chest com- 30aCHEST COMPRES-
pressions, then 2 rescue breaths – con- SIONS
tinue until patient is breathing normally. THEN 2 RESCUE BREATHS
a.When paediatric electrodes are used, CPR is carried out in the rhythm 15:2 if 2 rescuers are on the spot, otherwise in the 30:2 rhythm.
Art. no.: 0-48-0116 Rev.: b
Page 39
5 Defibrillation
5.6 Semi-Automatic Defibrillation DEFIGARD 4000
5.6.2 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
3. Switch the device to AED mode using the rotary switch.

4. Check the state of the patient.
5. Connect the electrode cable to the adapter.
6. You are prompted to continue the resuscitation and to stick on the electrodes.
7. Apply the defibrillation electrodes (see section 5.4.1, page 33).
The message CONNECT THE ELECTRODES is switched off as soon as the de-
vice measures an acceptable electrode resistance. If it is not switched off, see
section 5.4.1.
Fig. 5.7 Switch unit on
Step 2 Analysis
8. You are prompted to start the analysis.
9. Press the ANALYSE/CHARGE key. You are prompted to stay clear of the patient.
ANALYSE
CHARGE If the device detects ventricular fibrillation or ventricular tachycardia with a heart rate
exceeding 180 pulse/min, Shock delivery follows; otherwise continue with Step 4, Car-
diopulmonary resuscitation.
Fig. 5.8 Analysis
Art. no.: 0-48-0116 Rev.: b
Page 40
Defibrillation 5
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.

• Do not, under any circumstances, touch the patient during shock delivery.
• Make sure that the patient does not touch any conducting objects.
10. Deliver the shock by pressing the button .
After the shock delivery, step 4 follows.
Step 4 Cardiopulmonary resuscitation

11. Carry out cardiopulmonary resuscitation. Alternate between 30 chest compres-
sions and 2 breaths for 2 minutes. After 2 minutes, the device begins again with
Step 2, Analysis.
Art. no.: 0-48-0116 Rev.: b
Page 41
5 Defibrillation
5.7 Defibrillator Messages DEFIGARD 4000
5.7 Defibrillator Messages

Message Cause Remedy
SYNCHRO END • No pulse detected  Check ECG
SYNCHRO END • No pulse detected  Check ECG
• Weekly self-test on Sunday af-  Wait until the self-test is done
Auto test
ternoon
• Defibrillator capacitor is being  none
Charge in progress
charged
Defibrillator ready • -  -
Shock in progress • Shock in progress  -
Battery test • Battery is being tested  Wait until the battery test is done
Please Wait...
• No defibrillation energy has  Select the energy using the rotary switch
No energy selected!!!
been selected
Art. no.: 0-48-0116 Rev.: b
Page 42
Pacemaker 6
DEFIGARD 4000 User Guide Pacemaker Function 6.1
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 electrodes
and a 40 ms square-wave pulse reduce painful muscle contractions provoked by ex-
cessive 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 dur-
ing operation; therefore a functional test of the pacemaker module is not necessary.
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 neces-
sary ECG signal via the ECG electrodes. If the module is not able to reliably identify
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

Art. no.: 0-48-0116 Rev.: b
In the overdrive mode, the pacer will operate at three times the selected rate.
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 43
6 Pacemaker
6.2 Safety Notes DEFIGARD 4000
6.2 Safety Notes

 Shock hazard!
Never touch the pads or the patient's body near the pads while the pacemaker
is in use.
 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.
 For safety reasons, the external pacemaker should be disconnected from the
patient in this situation and an internal pacemaker should be used.
 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
Art. no.: 0-48-0116 Rev.: b
pacemaker current pulse flows only between the pacemaker electrodes.

• After each defibrillation, check that the pacemaker is functioning properly.
Page 44
Pacemaker 6
DEFIGARD 4000 User Guide Guidelines for the Application of External Pacemakers 6.3
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 36 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 33.
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.: 0-48-0116 Rev.: b
Page 45
6 Pacemaker
6.4 Start-up of the Pacemaker DEFIGARD 4000
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 Selecting pacemaker mode
1. Turn the rotary switch to select the Fix or Demand mode.

2. Display the softkeys by pressing the key.
The softkeys and pacemaker mode are displayed as follows:
Operational
mode
Fig. 6.3 Pacemaker mode
6.4.2 Pacemaker settings for fix mode

1. Select fix pacemaker mode.
2. Set the pacer rate using the function keys P +/-.
 Shock hazard!
Never touch the pads or the patient's body near the pads while the pacemaker is
in use.
3. Set the pacer output using the buttons mA +/- until the heart will certainly react on
the stimulation.
4. After the therapy, turn the rotary switch to position or before care-
Art. no.: 0-48-0116 Rev.: b
fully pulling the electrodes off the patient's body.

Fig. 6.4 Softkeys for pacemaker
Page 46
Pacemaker 6
DEFIGARD 4000 User Guide Start-up of the Pacemaker 6.4
6.4.3 Demand mode

1. Record an ECG with patient cable as described in section Connecting a 3-lead
ECG patient cable on page 23.
2. Attach the pacer pads. (See page 45.)
3. Turn the rotary switch to Demand mode.
4. Set the impulse current to 35 mA by pressing the mA + softkey.
5. Increase the pulse rate using the button P + until the symbol on the display
starts flashing. The pulse rate has now reached or slightly exceeded the intrinsic
heart rate.
6. Increase the impulse current using the button mA + until the heart reacts to the
stimulation (QRS complexes visible on the display).
7. Now set the required pulse rate using the P +/- keys.
Fig. 6.5 Intrinsic heart rate indicator 8. After the therapy, turn the rotary switch to position "0" or ECG before carefully
flashes pulling the electrodes off the patient's body.
6.4.4 Overdrive mode

1. Start the pacemaker as described in section 6.4 on page 46.
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.
4. Now let the P x3 key go. The heart should continue to beat with a normal heart
rate.
5. Finish the therapy.
Fig. 6.6 Softkeys for pacemaker

Art. no.: 0-48-0116 Rev.: b
Page 47
7 Finishing the Therapy
7.1 Finishing procedure DEFIGARD 4000
7 Finishing the Therapy

7.1 Finishing procedure
1. Switch the unit off as soon as the therapy is done (turn the rotary switch to posi-
tion ).
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. Clean the device as described in section 10.
Art. no.: 0-48-0116 Rev.: b
Page 48
Intervention Summary 8
DEFIGARD 4000 User Guide Finishing procedure 7.1
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
• Charging of the defibrillator
• 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.: 0-48-0116 Rev.: b
Page 49
8 Intervention Summary
8.1 Printing Curves and Measured Values DEFIGARD 4000
8.1 Printing Curves and Measured Values

The curves and parameter settings to be printed and the printing length are described
on page 54, section 9.5.
• The history for a defibrillation shock printout is always 4 seconds.
1. Press the Start/stop printout key. If no or a 3-lead ECG cable is connected, the
set curves are printed directly.
2. The printout can be stopped at any time using the start/stop printout key.
Fig. 8.1 Start/stop printout key
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 m m / s 0. 5 H z - 2 5H z
DG 4 00 0 94 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 : 4 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   ¦
The history for a defibrillation shock printout is always 4 seconds.
8.1.2 Printer error messages

Alarm Cause Remedy
RECORDER: NO PAPER! • No paper in the printer  Insert paper
RECORDER: DOOR OPEN! • Paper tray open  Close the paper tray
RECORDER: TIME OUT! • Paper jam in the printer  Open the paper tray and remove the paper jam
Art. no.: 0-48-0116 Rev.: b
Page 50
Device Configuration 9
DEFIGARD 4000 User Guide Menu Options 9.1
9 Device Configuration
For the monitoring of vital parameters, physiological alarm thresholds are preset in the
DEFIGARD® 4000, which are activated when the device is turned on. The device dis-
tinguishes between default and user-defined thresholds for adults and neonates.
The user's threshold values can be set via the key, whereas the standard
threshold values can only be changed in the DEVICE CONFIGURATION menu.
All changes are saved. When the device is put into operation for the first time, the us-
er-defined thresholds are identical with the default thresholds.
1. Keep the menu key pressed during unit switch-on. The main menu is displayed:
3. Switch the device off to exit the menu.
DEVICE CONFIGURATION
Options
Device
ECG/Defi
Alarms
Printer
9.1 Menu Options

Overview of the options installed
Menu Parameter Value

Options SpO2 Yes/No
SpO2 average time 8, 16
Pacemaker Yes/No
a Yes/No
Semi-automatic mode
a Yes/No
ECG memory
Printer Yes/No
Art. no.: 0-48-0116 Rev.: b
a. These options can only be accessed with a password from SCHILLER.
Page 51
9.2 Device DEFIGARD 4000
9.2 Device
Here below, the sub-menus are described.
9.2.1 Standard thresholds

With the Default key, the default threshold values are copied into the operator table.
Thresholds Adult Default
With the OFF key, all upper threshold values are set to "Off".
ECG HR 60 135 p/min With the Q-Set key, all values are derived from the current measured values. For:
SpO2 Pulse 90 165 p/min
% 90 97 % – Low threshold = -20%
– High threshold = +20%
Exit the menu by pressing "Back".
Fig. 9.1 Softkeys in the threshold menu
Adult
Parameter Min. Max. Unit

ECG HR 50 130 p/min
SpO2 Pulse 50 130 p/min
% 85 100 p/min
Neonates
Parameter Min. Max. Unit

ECG HR 50 130 p/min
% 85 100 p/min
9.2.2 Releases
Indication of software releases
9.2.3 Sounds/screen
Parameter Description Value
Alarm sound Volume setting High, Medium, Low
QRS sound Volume setting High, Medium, Low, Off
Art. no.: 0-48-0116 Rev.: b
Pace sound Volume setting High, Medium, Low, Off

Key sound Volume setting High, Medium, Low, Off
Voice sound Volume setting for AED instructions High, Medium, Low, Off
Brightness Screen brightness setting 0...100/50
Setting normal black on white or inversed,
Screen colors Black on white, White on black
white on black
Page 52
Device Configuration 9
DEFIGARD 4000 User Guide Device 9.2
9.2.4 Date/time
Parameter Value Note
• Date format DD/MM/YY or MM/DD/YY -
• Time format 24 or 12 h -
• Date/time Entry of the current date and
-
time
• Summer/winter time Yes/No -
9.2.5 Reserved SCHILLER

Menu can be accessed with a password only.
9.2.6 Language
Display language setting:
(DE) Deutsch, (GB) English, (FR) Français, (IT) Italiano, (PT) Português, (ES) Es-
pañol, (PL) Polski, (FI) Suomi, (NO) Norsk, (HR) Hrvatski, (CZ) Czech, (CS) Srpski,
(Sl) Slovensko
9.2.7 Serial number

Indication of the device's serial number.
Art. no.: 0-48-0116 Rev.: b
Page 53
9.3 ECG/Defi Menu DEFIGARD 4000
9.3 ECG/Defi Menu

Parameter Description Value
a Display of the second ECG curve. Is not displayed with SpO2. Yes/No
2nd ECG curve
Synchro at start Selection if shock should be direct or synchronised. Direct/Synchro
Selection if the setting for synchronised defibrillation should be
Synchro modification By key/Automatic
switched over automatically or by pressing a key.
ECG filter for noise suppression.
Noise suppression Yes = The ECG amplifier's band pass is reduced from Yes/No
0.05...150 Hz to 0.05...40 Hz on printouts containing 3 lead groups
(four-lead patient cable).
Notch filter Mains filter setting. None/50/60 Hz
a. The number of displayed ECG curves and selectable leads is determined by the type of the patient cable connected.
9.4 Alarms
Parameter Value
-4% SpO2 alarm Yes/No
Not locked = the alarm stops as soon as the measured value is again within
the preset alarm limits.
Physiological alarms
Locked = the alarm remains, even when the measured value is again within
the preset alarm limits.
Permanent reject Yes/No
This setting is not allowed in all countries. To activate it, keep the
key pressed for 3 s.
2’ alarm reject at start Yes/No
9.5 Printer
Parameter Value Note
• 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
9.6 Download
Art. no.: 0-48-0116 Rev.: b
This function is used for software downloads. To leave the menu, press the "Delete"
softkey.
The software can be downloaded via the USB interface (memory stick).
After the software download, it must be checked in the menu DEVICE CONFIGURA-
TION whether the software has been installed by the device.
Page 54
Maintenance 10
DEFIGARD 4000 User Guide Maintenance Intervals 10.1
10 Maintenance
10.1 Maintenance Intervals
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
• Replace battery and internal button cell  Service staff authorised by
Every 5 years
SCHILLER
10.1.1 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.
Art. no.: 0-48-0116 Rev.: b
Page 55
10 Maintenance
10.1 Maintenance Intervals DEFIGARD 4000
10.1.2 Functional test

 Switch the unit on.
Alarm tests
Heart rate 1. Start the ECG monitoring (see section 4.3.4, page 25).
2. Set the high and then the low heart rate threshold below/above the measured val-
ues.
3. When the measured value exceeds the alarm thresholds, an alarm is issued.
Reset the alarm limits to their original values.
SpO2 See section 4.4, page 27.
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.
Battery
Important
The battery is maintenance free during its normal life.
The battery must be replaced after 5 years, regardless of whether or not the unit has
been used.
Battery test The battery should be replaced if total battery operation has been less than 1.5 h.
1. Interrupt the device's mains supply.

2. Switch the unit on and check how long it runs powered by battery until the EMPTY
BATTERY message is issued.
Art. no.: 0-48-0116 Rev.: b
Page 56
Maintenance 10
DEFIGARD 4000 User Guide Disposal Information 10.2
10.2 Disposal Information

10.2.1 Battery disposal
 Danger of explosion! Battery may not be burned or disposed of with domestic

refuse.
 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.
10.2.2 Disposal of accessories that come into contact with the patient
 Disposable articles (e.g. electrodes etc.) must be disposed of as hospital waste.
10.2.3 Disposal at the end of the device's useful life

This unit must be disposed of in a municipally approved collection point or recycling
centre when no longer used.
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 the presence of
dangerous substances in electrical and electronic equipment.
Art. no.: 0-48-0116 Rev.: b
Page 57
10 Maintenance
10.3 Cleaning DEFIGARD 4000
10.3 Cleaning
10.3.1 Cleaning the casing
 Switch the unit off before cleaning and disconnect the mains. Do not, under any
circumstances, immerse the apparatus into a cleaning liquid or sterilise with hot
water, steam, or air.
 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.
 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.
10.3.2 Accessories and disposables
 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® 4000. 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.: 0-48-0116 Rev.: b
Page 58
Maintenance 10
DEFIGARD 4000 User Guide Error Detection 10.4
10.4 Error Detection

10.4.1 General errors
Error Cause Remedy
• Battery not inserted correctly or  Insert battery correctly or replace it
defective
The screen is not lit when
the device is switched on
• The device is defective  Replace device
Device cannot be switched • The device is defective  Replace device
off
• ECG signal too weak  Perform cardiac massage again
• ECG signal interference through  Turn off source of signal interference. e.g. radio equip-
electromagnetic waves ment or cell phone, or move patient outside field of inter-
No analysis
• Patient moved or touched during ference
analysis  Do not move or touch patient during analysis
• Battery too low  Change batteries
• Electrode error caused by resus-  Reapply electrodes
Unable to deliver shock citation measures
• Heart rhythm has changed  Run new analysis
10.4.2 Technical error messages
Alarm Cause Remedy

Electrode error • Technical error  Replace device
PROCESSOR ERROR • Technical error  Replace device
PROGRAM ERROR • Technical error  Replace device
ERROR DETECTION CIRCUIT FAILED • Technical error  Replace device
SELECTED ENERGY VOLTAGE REFERENCE • Technical error  Replace device
FAILED
ANALOG/DIGITAL CONVERTER ERROR • Technical error  Replace device
CHARGE TRANSISTOR ERROR • Technical error  Replace device
SAFETY DISCHARGE CIRCUIT FAILED • Technical error  Replace device
DEFI ERROR N. 8–11 • Technical error  Replace device
Art. no.: 0-48-0116 Rev.: b
DEFI ERROR N. 19–23 • Technical error  Replace device

COMPENSATION EPROM FAILED • Technical error  Replace device
SHOCK BUTTON FAILED • Technical error  Replace device
DEFI TIME OUT • Technical error  Replace device
CHARGE CIRCUIT FAILED • Technical error  Replace device
IGBT ERROR • Technical error  Replace device
PIC POWER SUPPLY FAILED • Technical error  Replace device
NO COMPATIBILITY BETWEEN HARDWARE AND • Technical error  Replace device
SOFTWARE
Page 59
10 Maintenance
10.4 Error Detection DEFIGARD 4000
10.4.3 Measures to prevent electromagnetic interferences

The device is designed for use in an electromagnetic environment in accordance with
IEC/EN 60601-1-2, tables 201, 202 and 204. If the device should nevertheless be dis-
turbed, especially in the vicinity of equipment labelled with the symbol “Non-ionic elec-
tromagnetic radiation", check the recommended minimum distance according to IEC/
EN 60101-1-2, table 206. For further details, please refer to the service handbook.
“Non-ionic electromagnetic radiation"
The following table lists devices and their typical frequency ranges and transmitting
power and the resulting minimum distances.
HF source Transmitter fre- Power P Distance d

quency [W] [m]
[MHz]
Radio telephone (microcellular) CT1+, CT2, CT3 885–887 0.010 0.23
Cordless DECT telephone, WLAN, UMTS handy 1880–2500 0.25 1.17
Mobile phone, handy USA 850/1900 0.6 1.8
Mobile phone, handy
- GSM900 900 2 3.3
- GSM850, NMT900, DCS 1800 850, 900, 1800 1 2.3
Walkie-talkie (rescue service, police, fire bri-
81–470 5 2.6
gade, service)
Mobile telephone system (rescue service, police,
81–470 100 11.7
fire brigade)
For transmitters not included in the above table, the recommended distance (d in me-
ters) can be calculated using the following formulas:
Frequency range 0.15–80 MHz

3.5
d = -------  P
3V
Frequency range 80–800 MHz

3.5
d = --------------  P
3V/m
Frequency range 800 MHz–2.5 GHz

7
d = --------------  P
3V/m
Art. no.: 0-48-0116 Rev.: b
d = recommended minimum distance in meters
P = transmitting power in Watts
Page 60
Technical Data 11
DEFIGARD 4000 User Guide System Data 11.1
11 Technical Data
Where nothing else is indicated, the data refer to a temperature of 25 °C.
11.1 System Data

Manufacturer SCHILLER MEDICAL
Device type DEFIGARD® 4000
Dimensions 270 x 310 x 160 mm (h x l x w)
Weight 5.3 kg
Protection case IP53 (protected against splash water)
Power supply
Voltage 100–240 VAC 50/60 Hz
Power consumption 65 VA
Battery operation Up to 3.5 hours
Fuses 2 x 2.5 A (T)
The unit is suitable for use in networks according to IEC 60601-1-2.
Battery
Battery type Lead-acid accumulator 12 V, 2 Ah
Autonomy 190 shocks with maximum energy or 3.5 hours monitoring
Environmental conditions
For operation • 0...40 ºC relative humidity at 30...95% (noncondensing)
• Atmospheric pressure 500...1060 hPa
For storage and transport • -10...50 ºC relative humidity at 0...95% (noncondensing)
• Atmospheric pressure 700...1060 hPa
Display
Type High-resolution colour LCD, backlit
Dimensions 132 x 75 mm (5.9“)
Printer High-resolution thermal printhead

Art. no.: 0-48-0116 Rev.: b
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 mm/s
Recording tracks 3-channel display, with optimal width of 72 mm
Connections ECG patient cable, SpO2
Interfaces • RS-232
• USB
For pins and the signal type, please contact the SCHILLER after-sales service.
Page 61
11 Technical Data
11.2 Classification and Safety Standards DEFIGARD 4000
11.2 Classification and Safety Standards

Conformity CE marking DEFIGARD 4000 bears the CE-0459 (Notified Body LNE/G-MED) mark indicating its
compliance with the provisions of the Council Directive 93/42/EEC (modified by the
Council Directive 2007/47/EEC) about medical devices and fulfills the essential re-
quirements of Annex I of this directive.
DEFIGARD 4000 is a Class IIb device.
Protection class Protection against electric shocks, Class I according to IEC/EN 60601-1
Safety standard IEC/EN 60601-2-4. Classified for frequent use.
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 discharges 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
Quality management system • The SCHILLER quality management system complies with the international stan-
dards ISO 9001 and ISO 13485.
Art. no.: 0-48-0116 Rev.: b
Page 62
Technical Data 11
DEFIGARD 4000 User Guide Defibrillation Pulse 11.3
11.3 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.
15
E = 200 J, Rp = 180 ohms, range = 141–180 ohms
10
-5
1 2 3 4 5 6 7 8 9 10 11 12
W
Standard energy settings Deviation at 50 3 J or 15 % (the higher value is assumed)
Adult AED configurable
Paediatric AED (configurable)
(automatic changeover when the paediatric electrodes are connected)
Paddles and adhesive elec- 0, 2, 4, 8, 15, 30, 50, 70, 90, 120, 150, 180, 200 joules
trodes
Charging time for shock (Time used to charge the storage capacitor to the max. energy of 200 J in manual
mode)
• with full battery
8 seconds
• with 90 V mains voltage after 15
9 seconds
discharges with max. energy emis-
sion
• from switch-on of the device with
paddles 18 seconds
• from switch-on of the device with
pads 25 seconds
Cycle Time Rhythm Analysis –

Shock Standby in AED Mode
Art. no.: 0-48-0116 Rev.: b
• with full battery

• with 90 V mains voltage after 15 1st shock = 20 sec; 2nd shock = 40 sec; 3rd shock = 60 sec
discharges with max. energy emis-
1st shock = 20 sec; 2nd shock = 40 sec; 3rd shock = 60 sec
sion
• from switch-on of the device to
charge at max. energy
1st shock = 35 sec; 2nd shock = 55 sec; 3rd shock = 75 sec
Cycle time shock – shock <25 s
Page 63
11 Technical Data
11.3 Defibrillation Pulse DEFIGARD 4000
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 rotary switch on the device
• Using the device's keyboard
Display of selected energy
Patient resistance 25...220
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
Defibrillation electrode connec-

tion
External defibrillation BF type
Defibrillation electrodes Electrode cable 1.95 m long

Adult electrode • 78 cm2 active surface
Pediatric electrode • 36 cm2 active surface
VF/VT detection Conditions for ECG analysis

VF/VT detection is only based on the ECG signal.
Minimal amplitude for signals to be analysed > 0.15 mV, signals < 0.15 mV assessed
as asystole
Shock recommendation
In case of VF and VT (VT > 180 p/min)
Art. no.: 0-48-0116 Rev.: b
Sensitivity VF 99.3% , VT 98.1%

Correct detection of shockable rhythms
Specificity
Correct detection of non-shockable rhythms These values were determined with an
AHA database containing VF and VT with or without artefacts.
– Specificity NSR (sinus rhythm): 100%

– Specificity of all other supraventricular rhythms: 99.3%
Page 64
Technical Data 11
DEFIGARD 4000 User Guide Technical Data – Measured Values 11.4
11.4 Technical Data – Measured Values

11.4.1 ECG
Leads Simultaneous, synchronous recording of all 9 active electrodes giving 12 leads
Patient cable 3-, 4-lead cable, CF classified
Heart rate
Range 30–300 beats/min
Accuracy ±2 beats/min
Lead display Selection of 1 or 2 simultaneous leads
Sensitivity 0.25, 0.5, 1, 2 cm/mV programmable
Blockage caused by defibrilla- Max. 5 seconds

tion shock
ECG amplifier band pass The band pass depends on the ECG source, the printer status and the print format
Patient cable type Without printout Continuous printout or as set Printout with 3 lead
groups
3 lead 0.5–40 Hz 0.5–40 Hz ---
4 lead 0.5–40 Hz 0.5–40 Hz 0.05–150 Hz
Defibrillator 0.5–25 Hz 0.5–25 Hz ---
11.4.2 SpO2 – pulsoximetry
Amplifier Masimo™ or Covidien
Operation Normal and sensitive
Accuracy SpO2
• Adults 1 to 100% ± 2 digits
• Paediatric70 to 100% ± 3 digits
PP
• 25...240/min ± 4 digits
Calibration range 70...100%
Connection Type CF
Measuring range SpO2 1...100%

Art. no.: 0-48-0116 Rev.: b
PP 25...240/min
Displayed range 1...100%
Blockage caused by defibrilla- Max. 10 seconds

tion shock
Page 65
11 Technical Data
11.5 Technical Pacemaker Data DEFIGARD 4000
11.4.3 Storage of intervention (option)
Saving
ECG and voice 30 minutes
Events 500 pcs.
11.5 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%
Signal connection Type CF, defibrillation protected
Readiness for operation Immediately
Art. no.: 0-48-0116 Rev.: b
Page 66
Appendix 12
DEFIGARD 4000 User Guide Accessories DEFIGARD 4000 12.1
12 Appendix
12.1 Accessories DEFIGARD 4000
Defibrillation accessories
Article no. Article description
35131 Defibrillation gel (250 ml)
EASY ELEC Adult pads
0-21-0000 Pediatric pads
0-21-0008 Defibrillation paddle adapter for children (x1)
ECG accessories
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
ECG electrodes with holding strap, 34 mm, (x50) for ba-
72366
nana plug cable
SpO2 accessories
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
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
Art. no.: 0-48-0116 Rev.: b
Page 67
12 Appendix
12.1 Accessories DEFIGARD 4000 DEFIGARD 4000
Pacemaker accessories
0-21-0013 Pacemaker/defibrillation pads adult
Various accessories
U32010 Power cable 2P+T, 2 m, 90° plug, European standard
0-50-0000 Paper
4-07-0015 Battery 12 V, 2 Ah
U50030 Earth cable
Art. no.: 0-48-0116 Rev.: b
Page 68
Appendix 12
DEFIGARD 4000 User Guide Literature 12.2
12.2 Literature
European Resuscitation Council Guidelines 2005 for Cardiopulmonary Resuscitation and Emergency Cardiovascular
(2005) Care (67 S1:1-146).
American Heart Association (2005) Guidelines 2005 for Cardiopulmonary Resuscitation and Emergency Cardiovascular
Care (9:1-170 ISBN 0080448704).
Cansell A. (2000) Wirksamkeit und Sicherheit neuer Impulskurvenformen bei transthorakaler Defibrilla-
tion – Biphasische Impulskurvenformen – Notfall- & Rettungsmedizin,
Springer-Verlag 3: 458 – 474.
12.3 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 Cardiovascular Life Support. (ACLS Manual AHA 2005)
AED Automated external defibrillator. This term is also used for semi-automatic defibrilla-
tors.
BLS Basic Life Support (artificial respiration and cardiac massage)

CPR is frequently used synonymously
CPR Cardiopulmonary resuscitation
CPR Cardiopulmonary resuscitation
PEA Pulseless electrical activity
VT Ventricular tachycardia
VF Ventricular fibrillation
Art. no.: 0-48-0116 Rev.: b
Page 69
12 Appendix
12.4 Inspection Report DEFIGARD 4000
12.4 Inspection Report

 The user guide must be read before the inspection.
 Recommended inspection interval: Before each use and monthly
Serial no.: ________________

Before each use
Checks Results Date
Visual inspection
• No isolation or mechanical dam- r r r r r
 External condition of the device
age
and accessories
• Patient cable and connectors un- r r r r r
damaged
• Accessories complete and in r r r r r
good condition
Inspection carried out by:
Monthly
Checks Results Date
Visual inspection
• No isolation or mechanical dam- r r r r r
 External condition
age
• Patient cable and connectors un- r r r r r
damaged
• Accessories complete and in r r r r r
good condition
Accessories
 Availability and condition • Electrodes (expiration date and r r r r r
compatibility)
• User guide r r r r
r
Battery Charging Test Connect the device to the mains:
r r r r r
• Mains LED lit r r r r r
• Battery LED flashing
Functional test Switch the device on – the self-test
see paragraph 3.2.3 is carried out.
Art. no.: 0-48-0116 Rev.: b
r r r r r
• No error message
Alarm Test Alarms are triggered according to r r r r r
see paragraph 10.1.2 the functional test.
Inspection carried out by:
In case of a defect, please contact the service department of your hospital ❒, your SCHILLER representative ❒ or the local after
sales service ❒.
Name: ................................................................... Tel.: ................................................................
Page 70
Index 13
13 Index
A Fixed-rate mode (Fix) ............................ 43
Accessories and disposables ..................... 58 Pacemaker patients.................................... 25
Patient resistance....................................... 64
Activating the audio alarm .......................... 21
Physiological alarms................................... 21
Alarm indicators.......................................... 21
Alarm messages......................................... 21
R
B Recharging time ......................................... 63
Rhythm, not shockable............................... 38
Battery
Battery life ............................................. 61
Battery disposal .......................................... 57 S
Battery type ................................................ 61 Safety discharge......................................... 64
Biocompatibility............................................. 8
Shock delivery ............................................ 64
Shock successful........................................ 38
C Shock unsuccessful.................................... 38
Shockable rhythm....................................... 37
Charge control and monitoring ................... 64
Cleaning ..................................................... 58 SpO2 error messages ................................ 28
SpO2 Menu ................................................ 28
Cycle time shock – shock ........................... 63
SpO2 monitoring ........................................ 27
Standard energy settings ........................... 63
D Step 2 – analysis ........................................ 40
Danger of electric shock! .............................. 2 Step 3 – Shock delivery.............................. 41
Danger of explosion.................................... 14 Step 4 – cardiopulmonary resuscitation ..... 41
Defibrillation Procedure .............................. 40 Suppressing an alarm sound...................... 21
Defibrillation pulse ...................................... 63 Symbols on the device ................................. 6
Defibrillation – semi-automatic ................... 37 Symbols used on the battery........................ 6
Demand mode ............................................ 43 Symbols used on the electrode package ..... 7
Synchronised defibrillation ......................... 35
Synchronised defibrillation using paddles .. 36
E
ECG error messages............................ 26, 28
ECG Menu.................................................. 26 T
ECG, quick diagnosis ................................. 23 Technical alarms ........................................ 21
Electrodes – adult and pediatric ................. 33
Electrodes, application ............................... 33
Error detection ............................................ 59
V
VF/VT detection.......................................... 64
Voice support ............................................. 39
F
First shock .................................................. 38
Functional test ............................................ 56
W
Warranty....................................................... 4
L
LCD ............................................................ 12
Art. no.: 0-48-0116 Rev.: b
M
Maintenance interval .................................. 55
Maintenance interval for the battery ........... 57
Manual defibrillation.................................... 31
Manual defibrillation using paddles ............ 32
Manual defibrillation using pads ................. 33
O
Operating elements .................................... 10
Operational readiness ................................ 16
P
Pacemaker
Page 71

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DEFIGARD 4000®

Defibrillator and Monitor

Article no.: 0-48-0116 Rev.: b

3 Start-up and Initial Preparation ............. 14

3.3 Inserting Printing Paper .................................................... 17

4.3.1 Quick diagnosis of the ECG using defibrillation electrodes ............. 23

6.3.1 Attaching the pacer pads ................................................................. 45

7 Finishing the Therapy ............................48

8 Intervention Summary ........................... 49

9 Device Configuration ............................. 51

11 Technical Data ........................................ 61

11.3 Defibrillation Pulse ............................................................. 63

12.4 Inspection Report ............................................................... 70

Art. no.: 0-48-0116 Rev.: b

1.2 Intended Use

1.3 Organisational Measures

1.4 Safety-Conscious Operation

1.5 Operation with other Devices

 Accessory equipment connected to the analogue and digital interfaces must be

1.7 General Safety Notes

1.8 Additional Terms

1.8.2 Terms of warranty

• assembly operations, extensions, readjustments, modifications, or repairs are car-

1.9 Display Symbols/Indicators

For general safety notes as listed in this section.

Reference to other user guides.

1.9.2 Symbols used on the device

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

Notified body of the CE certification (LNE/G-MED)

Note accompanying documents!

SCHILLER potential equalisation.

Symbol for the recognition of electrical and electronic equipment.

This unit must be disposed of in a municipally approved collection point or recycling

1.9.3 Symbols used on the battery

The unit/component can be recycled.

Battery may not be disposed of with domestic refuse.

Battery may not be burned.

Art. no.: 0-48-0116 Rev.: b

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

• 190 shocks with max. energy or

Data transmission • Easy transmission of a 3-lead ECG via GSM

2.1.1 Standard design and options of the DEFIGARD 4000

The following table shows the available options.

Options Paddles Adhesive elec-

With paddles (charging and shock

AED mode Manual Manual

• AED mode • Manual mode • Manual mode

2.2 Operating Elements

Swing-out carrying handle • On/off

ECG patient cable SpO2 connection Loudspeaker

2.2.2 Back panel

(1) Carrying handle

2.2.3 Paddle operation elements

Keys for energy charging and release

Fig. 2.3 Paddles operation elements

Fig. 2.4 LED indicator

ECG alarm mes- HR ECG

SpO2 waveform SpO2 measurement