PRIMEDIC ECO 1, Defi-Monitor DM 1, Defi-Monitor DM 3 User manual

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Instructions for use PRIMEDIC

™

Defi-Monitor ECO 1 / DM 1 / DM 3

Table of contents Page

1. Safety instructions 61

2. Device specification 63

3. Preliminary measures 71

3.1 Accumulator charging 71

3.2 Configuration of the defibrillator / ECG monitor (set-up menu) 72

4. Operation of the defibrillator 73

4.1 Switching the defibrillator on and off / self-test 73

4.2 Synchronous and asynchronous operation 74

4.3 Energy selection 75

4.4 Energy charging 75

4.5 Positioning of paddles 76

4.6 Discharging of energy (shock) 76

4.7 Paediatric paddles 77

5. Operation of the ECG monitor 78

5.1 Selection of ECG leads 78

5.2 Setting of signal amplification 79

5.3 Volume of systole beep 79

5.4 Activation of heartrate alarms 79

5.5 Contrast-Settings (only for ECO 1) 80

5.6 Filter 80

5.7 Positioning of ECG electrodes 81

6. Operation of SpO2 monitor (only model DM 3) 82

6.1 Connection of SpO2 sensor 82

6.2 Selection of correct SpO2 sensor 83

6.3 Setting of alarms for SpO2 84

7. Operation of printer 86

7.1 Protocol of the ECG signal 86

7.2 Automatic printout after every shock (auto print) 87

7.3 Printing of the event memory 88

7.4 Insertion of printing paper 89

8. Handling of the charging unit 89

9. Handling of the changeable accumulator 90

9.1 Changing of the accumulators 91

9.2 Parallel accumulator charging in the charging unit 91

10. Maintenance and care 92

11. Waste Treatment 93

12. Technical data, accessories, symbols 94

12.1 Technical data PRIMEDIC™ Defi-Monitor ECO 1 / DM 1 / DM 3 94

12.2 Accessories 96

12.3 Symbols 97

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Defi-Monitor ECO 1 / DM 1 / DM 3

Conditions of Guarantee 98

13.

14. Appendix 99

A1 General instructions and rules for the use of accumulators 99 A2 General instructions and rules for the handling of defibrillators 101 A3 General instructions for the use of pulsoximeters 107 A4 Voltage - time graphs 109 A5 Description of monitor screen and printouts 111 A6 Safety control 114

PRIMEDIC

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is registered trademark of METRAX GmbH, D-Rottweil

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Instructions for use PRIMEDIC

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Defi-Monitor ECO 1 / DM 1 / DM 3

1. Safety instructions

Your PRIMEDIC™ Defi-Monitor was designed in accordance with the high requirements of the use in emergency situations. Modern technology based on the many years of experience in the development and production of defibrillators together with new shock absorbing materials and new ideas offer the necessary support when every second counts.

The following has to be considered in order to ensure safe and perfect function of the PRIMEDIC Defi-Monitor and to avoid risk to human beings and other material property:

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1. Any use of the PRIMEDIC

Defi-Monitor requires the knowledge and strict compliance of

these instructions for use.

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2. The PRIMEDIC

Defi-Monitor is designed and suitable exclusively for the applications set out or described in this manual. Using the device for purposes any other than those mentioned in this manual may constitute a risk and has to be omitted.

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3. Operation of the PRIMEDIC

Defi-Monitor, as well as basically all other defibrillators, in

areas subject to explosion hazards is not allowed.

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4. The PRIMEDIC

Defi-Monitor may only be used by trained and authorised personnel.

Reading the instructions for use does not replace any training.

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5. Improper use or excessive operating duration of the SpO

sensor can cause tissue damages.

6. Strong light, movements and certain physical conditions of the patient, intravascular dye, incorrect attaching of the SpO saturation. Do not use the SpO

sensor could also result in wrong indications of oxygen

measure as single method to monitor the vital functions.

The instructions for the use of pulsoximeters have to be complied with (appendix A3).

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7. Any repair work, modifications, additions and installations of the PRIMEDIC

Defi-Monitor

may only be carried out by personnel authorised and trained by METRAX. The parts of the

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PRIMEDIC

Defi-Monitor may not be repaired by the user.

8. The device may only be used with accessories, wearing parts and disposable parts the secure use of which is proofed by an inspection office authorised to tests of devices ready-to-use.

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Otherwise a safe and reliable function of PRIMEDIC

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original PRIMEDIC

accessories and wearing parts comply with this condition.

Defi-Monitor is not guaranteed. The

9. Before using the device the user has to check that the device is in a safe and reliable state. If e.g. the pacer / defibrillator cable is damaged the defibrillator / pacer may not be used.

10. The instructions and rules set out in appendix A1, A2 and A3 have to be complied with when using the PRIMEDIC

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Defi-Monitor.

11. The unit must be under operating conditions before using. This is e.g. essential when storing the defibrillator in an ambulance car during winter.

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12. Do not use the PRIMEDIC

Defi-Monitor near devices (e.g. measuring devices) sensible to

magnetic fields or disturbing sources, which could interfere with the functions of

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PRIMEDIC

Defi-Monitor. Keep sufficient distance.

For the other states of the European Union the national regulations for the use of medical devices are applicable.

Manufacturer: METRAX GmbH

Rheinwaldstraße 22 D-78628 Rottweil Phone ++49 (0)741 / 257-0

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Instructions for use PRIMEDIC

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Defi-Monitor ECO 1 / DM 1 / DM 3

Fax ++49 (0)741 / 257-235

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Instructions for use PRIMEDIC

2. Device specification

15 17

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Defi-Monitor ECO 1 / DM 1 / DM 3

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Fig.: 1 General view of the PRIMEDIC

Defi-Monitor

1 ECG-unit with monitor and operating elements 2 Carrying handle 3 Input socket for ECG patient cable 4 ECG patient cable for recording the ECG 5 Defibrillator unit with operating elements 6 Paddle cable for APEX paddle 7 Release button for accumulator 8 Changeable accumulator 9 Paddle for APEX position 10 Release button 11 Printer with cover and compartment for paper reel 12 Release button 13 Paddle for STERNUM position 14 Paddle cable for sternum paddle 15 PRIMEDIC

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modular plug to connect modules as e.g. pacer module, I/D module for

internal defibrillation (only models DM 10 and DM 30)

16 Input socket for SpO 17 SpO

patient cable to connect NELLCOR® sensors (connector plug)

patient cable (only model DM 3)

(only model DM 3)

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20 21 22

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Defi-Monitor ECO 1 / DM 1 / DM 3

Fig.: 2 ECG-unit with operating elements and monitor ECO 1 20 ECG monitor high resolution EL monitor to show ECG signals and

important device parameters. 21 Key PADDLE LEAD To select the ECG signal of paddles. 22 Key LEAD SELECTION To select standard leads. 23 Key SIGNAL To set the amplification factors for the ECG signal. AMPLIFICATION 24 Key VOLUME To control the volume of the systole beep. 25 Key ALARM(SpO

) To activate alarm limits for low and high SpO2 values,

presettable in the set-up menu. 26 Key PAPER FEED Insertion of printing paper 27 Key PRINTER ON / OFF Switching ON / OFF the ECG on-line printing 28 Key ALARM To activate alarm limits for low and high heartrates, (heartrate) presettable in the set-up menu.

29 Key CONTRAST To change the monitor contrast, to adapt light and temperature

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Defi-Monitor ECO 1 / DM 1 / DM 3

Fig.: 3 ECG-unit with operating elements and monitor DM 1 / DM 3

20 ECG monitor high resolution EL monitor to show ECG signals and

26 Key PAPER FEED Insertion of printing paper 27 Key PRINTER ON / OFF Switching ON / OFF the ECG on-line printing 28 Key ALARM To activate alarm limits for low and high heartrates, (heartrate) presettable in the set-up menu.

) To activate alarm limits for low and high SpO2 values,

presettable in the set-up menu.

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Defi-Monitor ECO 1 / DM 1 / DM 3

Fig.: 4 Defibrillator unit with operating elements and displays ECO 1

30 Key ON / STAND-BY To switch the complete device on or to stand-by mode 31 LED To display the selected energy step 32 Key ENERGY To select the defibrillation energy 33 SYNC LED To indicate synchronous operating mode 34 Key SYNC To switch to synchronous operating mode 35 OK LED To signal that selected energy is charged and available for the shock

(defibrillation / cardioversion).

36 Attention LED To signal malfunction of the defibrillation unit 45 LED To signal the charging of the defibrillation energy

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Instructions for use PRIMEDIC

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Defi-Monitor ECO 1 / DM 1 / DM 3

Fig.: 5 Defibrillator unit with operating elements and displays DM 1 / DM 3

(defibrillation / cardioversion). 36 Attention LED To signal malfunction of the defibrillation unit

45 LED To signal the charging of the defibrillation energy

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Defi-Monitor ECO 1 / DM 1 / DM 3

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Fig.: 6 PRIMEDIC

Defi-Charger Charging unit with connections and indicators

50 Changeable Inserted in the charging shaft accumulator (optional) 51 Shaft To charge or to keep a second PRIMEDIC

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Accu 52 Charging module (option) To charge a second accumulator 53 LED green To signal that standby accumulator is being charged 54 LED green To signal accumulator capacity 90 - 100 % 55 LED yellow To signal accumulator capacity 50 - 90 % 56 LED red To signal accumulator capacity 10 - 50 % or a accumulator fault

while flashing 57 LED yellow To signal that the accumulator is being charged at the defibrillator 58 LED green To signal availability of energy to charge the defibrillator or the

optional standby accumulator 59 Contacts To transmit the charging current to the defibrillator 60 Charging base To insert the defibrillator 61 Fuse Circuit protection for 12 / 24 V on-board voltage 62 Universal socket To connect to the mains 63 Voltage selector To set voltage range 100 - 120 V or 200 - 240 V 64 Lead through housing To connect 12 / 24 V on-board voltage 65 Locking (optional) To lock the defibrillator in the charging unit 66 Release button (optional) One-hand release of the defibrillator 70 Plug To connect to universal socket (62) at the charging unit 71 Mains plug To connect to the mains socket

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The PRIMEDIC™ Defi-Monitor is an external defibrillator with integrated ECG monitor and on-line printer. The defibrillator can be synchronized with the ECG enabling synchronous cardioversions.

The device series is organised modularly. Several models are available:

PRIMEDIC

ECO 1 low cost model DM 1 basic model DM 3 with pulsoximeter DM 10 with module slot DM 30 with pulsoximeter and module slot

The modules Pacer, I/D (internal defibrillation) and R/D (free-handed defibrillation) can be connected to the module slots of DM 10 and DM 30.

The design of the PRIMEDIC and safe use in cases of emergency. All function units and operating elements are based on the following features:

• clear structure of the function units

• reduction to the essential functions

• logical user guidance

• clear, self-explaining operating elements

• ergonomical design

• retrofitable functions, due to the modular design

At the models DM 1, DM 3, DM 10 and DM 30 the ECG monitor has a high resolution graphic EL display ensuring clear screen contrast even under problematic lighting conditions.

The ECG monitor can be moved upwards and downwards allowing a perfect viewing angle towards the ECG shown, e.g.:

• in lying position outdoors

• in upright position with deep installation places in

As for the device versions DM 3 and DM 30 a continuous non-invasive measure of the functional oxygen saturation of arterial haemoglobin (SpO

monitor is provided with a high-quality measuring module from NELLCOR PURITAN BENNETT Inc.

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Defi-Monitor ECO 1 / DM 1 / DM 3

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Defi-Monitor

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Defi-Monitor allows quick

ambulances.

) is possible. The PRIMEDIC

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Instructions for use PRIMEDIC

Together with the in Capter 6.2 (Selection of correct SpO sensor) adviced sensors, a continuous monitoring of adult or paediatric patients is possible. Parallel to the measurement in % a continuous pulse curve is displayed in the monitor. This can be documented by the use of the high resolution printer.

During the measurement of the oxygen saturation, alarm thresholds can be activated to indicate changes in the patient’s condition.

The printer can be used to document the monitoring as well as to record the emergency situation (the 5 s before and 5 s after every shock).

The defibrillator allows safe and extremely quick use:

• Charging time for 100 joule approx. 1 s (*)

• Charging time for 360 joule approx. 5 s (*)

(*) = when accumulator capacity is 90 % of nominal value. A module slot is provided at the sides of models DM 10 and

DM 30, where e.g. a pacer module may be inserted, which is particularly operator-friendly. In contrast to common pacers the paddle does not have to be removed in order to connect the pacer- / defibrillation cable. With PRIMEDIC

pacers the pacer- / defibrillation cable is simply attached to the module. If the pacer- / defibrillation cables are

connected, the paddle electrodes are switched-off.

If during the pacer process a defibrillation is necessary, a shock may be released via cushion electrodes. The release buttons of the module control the charging of energy and the release of a shock. Also without the pacer being active freehanded defibrillation may be carried out with the cushion electrodes.

If the pacer is not needed and the user does not wish to apply the energy via paddle, the R/D module may be used. To this module the cushion electrodes for the free-handed defibrillation are connected.

By means of the I/D module for internal defibrillation the internal electrodes can be connected via a sterilised patient cable. In case of working at an open thorax a wide range of internal electrodes is available.

The power supply of the PRIMEDIC provided by changeable accumulators with NiCd cells. The applied charging electronics corresponds to the latest technology thus assuring a maximum service life of the accumulators used.

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Defi-Monitor ECO 1 / DM 1 / DM 3

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Defi-Monitor is

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Instructions for use PRIMEDIC

In rest position the PRIMEDIC™ Defi-Monitor can be inserted into a charging unit. Wall mounting or mounting into a vehicle is possible by means of various adapters (optional). In an emergency case the PRIMEDIC be released easily and quickly with one hand.

The electric connections (mains voltage or DC on-board voltage) are fitted in the charging unit. The charging unit also supplies the power for the accumulator charging.

A comfort version of the unit is available as option allowing to charge a second changeable accumulator. When using the comfort version with Accu-Care function the accumulator receives best maintenance which prevents the problematic memory effect. Retrofitting of all standard charging units with the Accu-Care option is possible. The PRIMEDIC

Monitor can also be operated while sitting on the charging unit. For safety reasons the accumulator has to be connected during operation to avoid removing the defibrillator from the charging unit without accumulator in case of emergency.

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Defi-Monitor ECO 1 / DM 1 / DM 3

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Defi-Monitor can

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Defi-

A variety of accessories are available.

3. Preliminary measures

3.1 Accumulator charging

The changeable accumulator has to be charged before first use of the PRIMEDIC

Lock the changeable accumulator at the provided and marked location from the side in its position (see also section

9.1). Then insert the PRIMEDIC

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PRIMEDIC

Defi-Charger. The green LED (58) lights up to indicate that power is supplied to the charging unit (mains or on-board voltage).

When the accumulator needs to be charged the charging electronics starts the charging process, this indicated by the charging LED (57) of the charging unit. At the end of the charging procedure the charging LED (57) goes off.

Caution:

A completely discharged battery has to be recharged for at least 45 minutes. A too short charging duration may lead to a wrong interpretation of the battery charge by the device due to the nature of the battery. The battery charge monitor in the display will falsely indicate a full battery. A safe operation of the device under certain circumstances will not be guarantied.

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Defi-Monitor.

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Defi-Monitor into the

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Instructions for use PRIMEDIC

3.2 Configuration of the defibrillator / ECG

The PRIMEDIC™ Defi-Monitor was configured at the factory. Certain parameters can be changed in the set-up menu in order to realize individual settings. This configuration remains until it is changed regardless whether the defibrillator is switched off or the accumulator is changed.

The set-up menu is partitioned on two pages. On page 1 the following parameters can be changed.

The underlined parameters represent the factory setting.

1. Filter Off / 50 Hz

2. Date DD.MM.JJ

3. Time hh.mm.ss

4. Language deutsch

5. Automatic

6. Print 1-lead

7. Print 25 mm

8. Memo-Print activate *= with installed software option.

*=only for DM 1 and DM 3 eligible. The second page allows the following settings:

4. SpO

5. SpO 6 SpO

*= only for DM 3 eligible Press PADDLE-LEAD (21) and LEAD SELECTION (22)

simultaneously during operation in order to start the set-up menu. The set-up menu is displayed.

During the configuration keys (21), (24) and (28) have special functions of which the symbols are displayed on the monitor.

Key (21) UP (σ) Key (24) DOWN (τ) Key (28) OK (↵)

Use these keys to control the configuration.

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Defi-Monitor ECO 1 / DM 1 / DM 3

monitor (set-up menu)

/ 60 Hz

/ english / français /

espanol / portugesh

printing On / Off

/ 3-lead *

/ 50 mm *

♥ Alarm 1 30 / 90 ♥ Alarm 2 40 / 130 ♥ Alarm 3 50 / 180

Alarm 1 95 / 100**

Alarm 2 90 / 100**

Alarm 3 80 / 100**

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Instructions for use PRIMEDIC

When calling up the set-up menu the first menu item is marked. To change e. g. the time move the cursor downwards by actuating DOWN (24) one or several times until the menu item time is marked. Select the menu item time by actuating OK (28). Then the cursor moves to the hour which is changed by actuating UP (21) or DOWN (24). Confirm the correct setting with OK (28). The cursor then moves to the minutes which can be changed in the same way as described. When confirming with OK (28) the cursor returns to the menu item time. Now you can realize further changes in the same way as described in the example time.

To quit the set-up menu move the cursor to the menu item END by means of UP (21) or DOWN (24) and confirm with OK (28). Then the PRIMEDIC operation.

Note:

If during the setting of the menu parameters the defibrillator has to be used immediately because of an emergency the setup menu can be terminated immediately by pressing ENERGY (32).

4. Operation of the defibrillator

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Defi-Monitor ECO 1 / DM 1 / DM 3

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Defi-Monitor returns to monitoring

4.1 Switching the defibrillator on and off /

self-test

Press ON / STAND-BY (30) shortly to switch on the

PRIMEDIC

To switch off, press ON / STAND-BY (30) for approx. 2 secs. During switch off procedure an acoustic signal is given. This time was chosen to prevent the device from being switched off accidentally. Energy that possibly has been charged for the defibrillation will automatically be discharged internally.

Note:

The complete device is switched on and off with ON/ STAND-BY (30). Thus the functions of all components can be used without loosing time.

When starting an internal self-test will be executed to check important functions and signal devices. All LEDs of the defibrillator light up for approx. 2 seconds. Be sure that all LEDs are active. During this time a warning buzzer has to be on as well. It is important that the buzzer functions.

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Defi-Monitor.

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Instructions for use PRIMEDIC

Attention:

If one or several LEDs or the warning buzzer do not function, the defect has to be eliminated immediately.

4.2 Synchronous and asynchronous

When switching on the PRIMEDIC™ Defi-Monitor the defibrillator is automatically in asynchronous operation.

Press SYNC (34) to select synchronous operation of the defibrillator (cardioversion) if required by the emergency situation.

LED (33) signals the synchronous operation. In addition, the note "SYNC" is displayed on the ECG monitor.

After a synchronous discharge (cardioversion) the defibrillator switches back to asynchronous operation.

Note:

During synchronous operation ECG markings are shown on the monitor. For safe synchronous operation these cardioversion markers must appear in every QRS complex with a R-peak. A clear, artefactfree ECG signal with sufficient amplitude is essential.

If there are no markings shown on the ECG monitor, the amplitude probably has to be changed by means of SIGNAL AMPLIFICATION or a lead with improved signal quality has to be selected.

Note:

Do not use the paddles but the external ECG patient electrodes for the ECG recording during synchronous operation. Otherwise artefacts can be caused when moving the paddles which leads to faulty synchronization.

Note:

The delay time between the recognition of a QRS complex (synchronous pulse) and energy discharge is less than 60 ms.

Attention:

Before releasing the cardioversion check on the monitor whether the cardioversion markers are clearly related to the R-peaks and do not react e. g. to pacemaker pulses or artefacts.

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Defi-Monitor ECO 1 / DM 1 / DM 3

operation

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Instructions for use PRIMEDIC

4.3 Energy selection

Press one of keys (32) to select the energy. LED (31) located directly above the key pressed lights up to acknowledge the energy setting. In addition the selected energy step is indicated on the monitor.

Note:

The energy step required for the defibrillation / cardioversion depends on the patient, its body height and weight and its condition. For information please refer to appendix A2.

An energy step selected by mistake can be changed by pressing the correct key with the required energy step. This is also possible if energy has already been charged for defibrillation. When increasing the energy step the missing energy is added. When decreasing the energy step the excessive energy is discharged in small steps.

4.4 Energy charging

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Defi-Monitor ECO 1 / DM 1 / DM 3

The selected energy can be charged by pressing one of the release buttons (10) or (12) and thus made available for the shock.

Then the energy will be charged quickly. LED (45) flashing indicates the charging procedure. The charging time depends on the selected energy step and the available accumulator capacity. Charging the defibrillator up to 100 joule takes approx. 1 second, charging up to 360 joule takes about 5 second. In case of a partly discharged accumulator the charging time may slightly be longer. See also technical data.

After the charging the energy will be available for 15 seconds which is signalled by a permanent signal and the lighting up of the OK signal (35). The remaining time is simultaneously indicated on the monitor. If there is no defibrillation during this time, an internal safety discharge will be executed.

During this time the energy charged can be changed again if required (see section 4.3). After the change, the energy is available for another 15 seconds for defibrillation.

Should an error occur during energy charging, an intermittent warning signal and the Attention LED (36) will be on.

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Attention:

If the message „load accumulator“ appears at least 5 discharges with maximum energy are available, in this case the Defi-Monitor should be placed again as fast as possible on the charging unit.

Attention:

If the ATTENTION LED (36) lights up the function of the defibrillator can be tested by switching-off and then on again with the help of a self-test. When the signal goes out, the defibrillator is ready-to-use.

Attention:

If the ATTENTION LED (36) is still on after switching off and on again, the malfunction must be eliminated immediately.

4.5 Positioning of paddles

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Defi-Monitor ECO 1 / DM 1 / DM 3

The paddles must be positioned along the cardiac axis. APEX paddle (9) hast to be positioned in the left chest area,

on the axillary line above the apex of the heart. STERNUM paddle (13) hat to be positioned in the right chest

area, below the clavicle.

4.6 Discharging of energy (shock)

Press release buttons (10) and (12) at the paddles simultaneously to discharge the energy.

In case of asynchronous operation energy will be discharged immediately after simultaneous depression of buttons.

In case of synchronous operation both release buttons (10) and (12) have to be pressed down simultaneously until the moment for the cardioversion is reached. During this time an intermittent signal will be on.

No cardioversion will be released, if during discharging the release buttons are let go off.

The energy is discharged internally if no synchronization takes place within 3 seconds while keeping the release buttons pressed down. Thereafter, the PRIMEDIC returns to asynchronous mode.

During the shock the ECG input will generally be overloaded for a short time. The PRIMEDIC a stable ECG baseline already after approx. 1 second after the shock so that the defibrillation success can be seen immediately.

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Defi-Monitor will supply

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Defi-Monitor

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Instructions for use PRIMEDIC

Attention:

Before releasing the cardioversion check on the monitor whether the cardioversion markers on the monitor are clearly related to the R-peaks and do not react e. g. to pacemaker pulses or artefacts.

Attention:

Both paddles have to be pressed on the thorax by applying a pressure of approx. 100 N in order to ensure safe energy transmission and to avoid damaging the skin under the paddles.

Attention:

Please insure that there is no contact or conducting gel between the paddles.

Attention:

Before and during the discharging of energy all persons attending to the resuscitation have to step back and any contact with patients or conducting parts (e. g. stretcher) has to be avoided. Remove all connected devices without defibrillation protection from the patient before energy is discharged.

4.7 Paediatric paddles

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Defi-Monitor ECO 1 / DM 1 / DM 3

Electrodes with smaller electrode surface have to be used for the defibrillation of children. The paediatric paddles are integrated in the paddles for adults. Remove the large electrodes from both paddles by turning counterclockwise.

Attach the paddles for adults to the paediatric electrodes by turning clockwise.

Note:

Clean the paediatric paddles after use before attaching the paddles for adults.

Attention:

Attach the paddles for adults firmly to ensure safe contact of the paddles for adults.

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Instructions for use PRIMEDIC

5. Operation of the ECG monitor

5.1 Selection of ECG leads

The ECG graph can be realized in two ways:

1. via paddles

2. via external ECG patient cables. The paddle lead is automatically active after switching on the

PRIMEDIC

symbol on the monitor. The monitor cannot be switched to the standard leads if no

external ECG patient cable is connected. The standard leads can be used if an ECG patient cable is

connected. Press LEAD SELECTION (22). Lead II is immediately active. Press LEAD SELECTION (22) to switch between the possible leads I, II, III, aVR*, aVL* or aVF*. The selected lead is shown on the monitor.

To switch back to lead via paddle electrodes press PADDLELEAD (21) regardless whether ECG signals are available via the external patient cable.

The monitor automatically switches to paddle lead when pulling out the ECG patient cable from the input socket of the

PRIMEDIC

Note:

The PRIMEDIC when no ECG is shown or no key is pressed for 15 minutes while the device is switched on. Approx. 30 seconds before switching off an acoustic signal is given. By pressing any key, the switching off routine is interrupted.

Note:

If the paddle lead is selected and the paddles are not attached to the patient, an intermitting line with the message „Electrodes open“ will be displayed in the monitor. As soon as the paddles are attached to the patient, the recorded ECG signal will be displayed in the monitor.

= only for DM 1 and DM 3 with installed software option.

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Defi-Monitor ECO 1 / DM 1 / DM 3

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Defi-Monitor which is indicated by a paddle

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Defi-Monitor during the monitoring.

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Defi-Monitor switches off automatically

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Instructions for use PRIMEDIC

5.2 Setting of signal amplification

Five signal amplification steps are available:

1. 0.5 cm/mV

2. 0.8 cm/mV

3. 1.0 cm/mV

4. 1.5 cm/mV 5 2.0 cm/mV

Amplification step 1 cm/mV is automatically active after switching on the PRIMEDIC AMPLIFICATION (23) to switch between the amplification steps in ring counting method. The 1mV reference is constantly shown on the left of the monitor border. After switching to a different value the reference marking is shown for about 5 seconds in lower status line.

5.3 Volume of systole beep

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Defi-Monitor ECO 1 / DM 1 / DM 3

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Defi-Monitor. Press SIGNAL

Three volume steps are available for the systole beep: off, low, high.

After switching on the volume step off is automatically active. The volume symbol is shown on the monitor.

Press VOLUME (24) to switch between the three volume steps. Each depression on key (24) causes the continuation by one step.

5.4 Activation of heartrate alarms

Four steps are available:

1. — — —

♥ ALARM 1 30 / 90 ♥ ALARM 2 40 / 130

♥ ALARM 3 50 / 180

4. The above mentioned alarm limits are preset at delivery. The

values of the second and fourth alarm step can be changed by means of the set-up menu (see section 3.2).

The alarm is not active after switching on the PRIMEDIC Defi-Monitor which is indicated on the monitor. Press

ALARM (28) for activation. Every depression of this key causes the continuation by one alarm step.

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Instructions for use PRIMEDIC

The value indicated on the monitor (e. g. SpO be released when exceeding the heartrate of 90 beats/ minute or remaining under 30 beats / minute. You can acknowledge (switch off) the alarm by pressing ALARM (28) shortly. The acoustic alarm is switched off for about 1 minute whereas the alarm limits remain. To change the alarm limits or to switch off the alarm press ALARM (28) until the desired

selection (e. g. After the defibrillation the heart alarms are set OFF

automatically.

Note:

Test possibility for alarm circuit. Select alarm limits with no patient connected. The optical and acoustical alarm has to be released immediately. After acknowledging ALARM (press button 28) the acoustical alarm is suppressed for about 1 minute. The optical alarm has to remain active (intermittent alarm signal).

5.5 Contrast-Settings (only for ECO 1)

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Defi-Monitor ECO 1 / DM 1 / DM 3

♥ ALARM 30 / 90,

90 / 100) means that a pulsating acoustic alarm will

♥ ALARM — — —) is shown on the monitor.

Five different contrast settings are available. Depending on the ambient temperature or brightness it may be useful to change the contrast for high-contrast monitoring. The most suitable contrast step can be determined by repeated actuation of CONTRAST (29). After switching off the

PRIMEDIC

saved and active again when switching on.

™

Defi - Monitor the current contrast setting is

5.6 Filter

The monitoring has the possibility to use high-quality line filter with 50 or 60 Hz. This can be adjusted in set-up menu (see section 3.2). It is recommendable to activate the 50 Hz filter.

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Instructions for use PRIMEDIC

5.7 Positioning of ECG electrodes

The quality of the indicated ECG signal depends among others on the safe contact and correct positioning of the ECG electrodes.

Position the electrodes carefully in order to minimize the movement artefacts.

Positioning of disposable electrodes:

1. Connect the plug of the patient cable (4) to the ECG plug-

2. Attach the patient electrode cable firmly to the electrode

3. Pull the lamination sheet off the electrodes.

4. Make sure that there is no electrolyte gel on the adherent

5. Stick the electrodes to the skin of the patient by pressing

Positioning of electrodes with four-wire cable (with neutral electrode):

Electrode Position

™

Defi-Monitor ECO 1 / DM 1 / DM 3

in connection (3) so that it engages audibly. by means of the clip connection.

surface. the adherent surface firmly against the skin. Positioning

according to the table.

Red (R) directly below the right medioclavicle Yellow (L) directly below the left medioclavicle Green (F) directly below the left pectoral muscle on

the medioclavicle line

Black (N) right side of the body, e. g. lowest rib on the

medioclavicle line

After use remove the disposable electrodes by pressing together the electrode bracket. Do not apply used disposable electrodes!

Note:

Use silver / silver chloride electrodes (Ag / AgCI) in order to minimize a polarization of the electrodes during defibrillation.

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Instructions for use PRIMEDIC

Attention:

Only use the original- PRIMEDIC cable has an integrated defibrillation protection protecting the ECG monitor from dangerous high voltage. The use of another patient cable may cause the destruction of the ECG unit and may be hazardous to the user.

Attention:

The black ECG electrode (N) always has to be connected, to guarantee the function of the identification of electrodes open.

6. Operation of SpO2 monitor (only model

6.1 Connection of SpO2 sensor

The PRIMEDIC pulsoximeter module is provided with a blue input socket (16) at the upper left of the casing for the SpO

Proceed as follows:

1. Insert into slot (16) the blue plug (17) of the patient cable

2. Plug the NELLCOR

3. Test the perfect mechanical locking of the plug-in-

To dismount the NELLCOR cable, push the release of the plug-in-connection and take out the sensor without applying force.

If the NELLCOR about 5 seconds of measuring time the value in % and the pulse curve are shown on the monitor. A rhythmically oscillating signal bar at the right fringe of the pulse curve indicates when the module recognizes an evaluable oxygen saturation value.

Note:

Do not kink sensor or patient cable to avoid defects or malfunctions.

™

Defi-Monitor ECO 1 / DM 1 / DM 3

™

patient cable. This patient

DM 3)

™

Defi-Monitor with integrated NELLCOR ®

patient cable.

(about 1,4 m). patient cable until the traction relief engages. connection.

sensor into the other end of the SpO

sensor from the SpO2 patient

sensor is positioned on a patient, after

82 19499 / 05.03

Instructions for use PRIMEDIC

Note:

Reusable sensors may remain at one measuring point for 4 h maximally, provided that state of the skin, the correct and secure positioning of the sensor at the measuring point are controlled regularly. As the tolerance towards sensors at the measuring point depends upon the individual condition of the skin, it may be necessary to change the points of measure with some patients.

Note:

Before using the sensor read the instructions for use.

Attention:

Do not use damaged sensors or sensors with unprotected optical components.

Attention:

Only use original NELLCOR sensores could cause measuring errors or damage the SpO module.

Attention:

Always use original SpO perfect connection of NELLCOR

Attention:

Avoid tensile load at the NELLCOR cable.

6.2 Selection of correct SpO2 sensor

™

Defi-Monitor ECO 1 / DM 1 / DM 3

sensors for SpO2 measures. Other

patient cables which guarantee the

sensors to the Defi-Monitor.

sensor or the SpO2 patient

In order to select the correct sensor for the respective application it is necessary taking into account the following facts:

• weight of the patient

• activity of the patient

• duration of the measure

• blood circulation of the limbs

Also observe the instructions for the use of pulsoximeters in appendix A3.

The following table summarizes the most important NELLCOR the PRIMEDIC

sensors with appropriate fields of applications for

™

Defi-Monitor.

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Instructions for use PRIMEDIC

NELLCOR Sensors

DS-100 A > 40 kg operator-friendly, D-YS > 1 kg universal sensor,

RS-10 > 40 kg reflecting sensor,

OXI-A/N < 3 or > 40 kg reusable, insteril disposable OXI-P/I 3 - 40 kg reusable, insteril disposable

More NELLCORE detailed documentation.

Note:

Operating instructions for the above mentioned sensores are provided in the instructions for use.

Attention:

Only use the sensores according to their determined purpose

(weight of the patient, measuring point .....). Exact notes and

instructions for the correct use can be seen in the instructions for use of the corresponding sensors.

6.3 Setting of alarms for SpO2

™

Defi-Monitor ECO 1 / DM 1 / DM 3

Weight of

special features

the patient

reusable reusable,

applicable with ear clip attachable at forehead or

temple, especially for patients with reduced peripheral circulation, reusable

adherend adherend

sensors are available. Please ask for our

Four steps are available:

1. — — —

2. SpO

3. SpO

4. SpO

alarm 1 95 / 100

alarm 2 90 / 100

alarm 3 80 / 100

The above mentioned alarm limits are preset at delivery. The values of alarm step 2 to 4 can be changed by means of the set-up menu (see chapter 3.2). The setting range for the lower alarm limit lies between 80 - 99 %, for the upper alarm limit between 90 - 100 %.

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Instructions for use PRIMEDIC

After switching on the PRIMEDIC™ Defi-Monitor the alarm is not active. This is shown on the monitor. The alarm can be activated by pressing the SpO ALARM (25) operates in ring counting method, i.e. every depression of the key causes a continuation by one alarm step.

The message displayed on the monitor (e.g. SpO / 90) means that a rhythmic alarm is released when a SpO value is falling below 80 % or passing 90%. The alarm bell flashes. If the alarm is released it can be acknowledged (switched off) by shortly pressing SpO ALARM (25). The alarm audio signal is switched off for about a minute. The alarm bell symbol is crossed out during muting. If you want to change the alarm limits or switch of the alarm, press SpO ALARM

After a defibrillation the SpO OFF.

Note:

If no SpO

− no sensor or SpO

− sensor damaged

The alarm will be released in any of the above mentioned cases with alarm limits activated.

™

Defi-Monitor ECO 1 / DM 1 / DM 3

ALARM (25). The SpO

ALARM 80

ALARM (25) until the desired message e.g. SpO2

— — —is displayed on the monitor.

ALARMs are automatically set

value is displayed, this can mean that:

patient cable is connected

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Instructions for use PRIMEDIC

7. Operation of printer

7.1 Protocol of the ECG signal

The PRIMEDIC™ Defi-Monitor has a printer with high resolution. ECG prints of 3 channels at a time are possible, at printing speeds of 25 and 50 mm/s*.

To protocol the ECG graph during monitoring the on-line printing has to be started by pressing PRINTER ON/OFF (27).

Repeated actuation of PRINTER ON/OFF (27) stops the printing of the protocol. Printing is with 2 seconds delay. The ECG is printed with the parameters chosen in the set-up menu. The following set-up possibilities are available:

1-channel-print prints the ECG channel displayed on

3-channel-print * prints channel I, II, III or aVR, aVL, aVF

25 mm/s -printing speed*

50 mm/s - printing speed*

As for device version DM 3 it is possible to print the SpO protocol printing quality, but only in the 1-channel-mode.

Printing is started 3 seconds after some information is displayed on the monitor, i.e. events that happened before the activation of the print can be represented.

The cutting edge integrated in the printer cover (11) allows to cut off the ECG protocol tape. Cut off the tape by pulling sideways to the top.

Note:

Well-thought and short-time printing saves energy and paper and increases the mains-independent operating time of the device, especially in case of printing at a speed of 50 mm

*= as for DM 1 only with installed software package. * = only for DM 1 and DM 3.

™

Defi-Monitor ECO 1 / DM 1 / DM 3

the monitor. With SpO active the SpO

pulse curve is

measure

displayed additionally.

simultaneously, depending upon the lead displayed on the monitor.

The information is printed at 25 mm/s.

The information is printed at 50 mm/s.

86 19499 / 05.03

Instructions for use PRIMEDIC

7.2 Automatic printout after every shock

With the PRIMEDIC™ Defi-Monitor it is possible to protocol automatically the event after every shock (defibrillation / cardioversion). The 5 seconds before and 5 seconds after every shock are documented. All important parameters are printed in the beginning:

• Date, time

• Energy (joule)

• Synchronous / asynchronous operation

• Lead

• Heartrate

• Filter

• Signal intensification

• Lines for additional notes

• SpO

• Speed

The auto print function can be switched on and off in the setup menu. The function is switched off at delivery.

Use the cutting edge integrated in the printer cover (11) to cut off the ECG protocol tape. Cut off the tape by pulling sideways to the top.

Note:

The auto print function switched on in the set-up menu remains active even after switching off the defibrillator or changing the accumulator. The device configuration has to be changed in the set-up menu in order to deactivate this function.

™

Defi-Monitor ECO 1 / DM 1 / DM 3

(auto print)

value (only model DM 3)

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Instructions for use PRIMEDIC

7.3 Printing of the event memory

The PRIMEDIC™ Defi-Monitor saves the last 10 shocks (defibrillations/cardioversions) automatically in an event memory. The 5 seconds before and 5 seconds after every shock, as well as all important parameters are saved:

• Date, time

• Energy (joule)

• Synchronous / asynchronous operation

• Lead

• Heartrate

• Filter

• Signal intensification

• Lines for additional notes

• SpO

• Speed

Every new event pushes the oldest event out of the memory. With the set-up menu the memory contents beginning with the last event are printed, by using the just actual signal intensification.

Call the set-up menu and move with cursor key to item “Memo-Print“, acknowledge “activate“. The memo print starts. To stop the printout press PRINTER ON / OFF (27). The print speed is 25 mm/s.

Use the cutting edge integrated in the printer cover (11) to cut off the ECG protocol tape. Cut off the tape by pulling sideways to the top.

Note:

After printing the data remains in the event memory. The data can be printed as often as necessary.

™

Defi-Monitor ECO 1 / DM 1 / DM 3

value (only with model DM 3)

88 19499 / 05.03

Instructions for use PRIMEDIC

7.4 Insertion of printing paper

Fold down the printer cover (11) to the front to insert the printing paper (paper reel). Prepare the paper reel provided (remove the adhesive strip, uncoil approx. 10 cm of paper). Insert the paper reel into the printer shaft so that the paper runs as per the opposite drawing. Otherwise the paper would be printed on the reverse. Hold the end of the paper against the rubber cylinder and press PAPER FEED (26). The paper now takes its starting position.

Close the cover (11) and press again PAPER FEED (26). The paper will be fed automatically through the cover shaft up to the cutting edge.

Note:

The cover is designed in such a way that it jumps out of its position without being damaged when applying stronger external pressure. Replace the cover by pushing back the snap lockings by means of a screw driver until the cover engages.

™

Defi-Monitor ECO 1 / DM 1 / DM 3

8. Handling of the charging unit

After every use the PRIMEDIC™ Defi-Monitor should be inserted into the charging unit in order to recharge the accumulator. Otherwise a second charged PRIMEDIC has to be available or the accumulator has to be charged with the external charging/regenerating table unit in order to be prepared for a case of emergency.

When inserting the defibrillator into the charging unit the springs have contact and the accumulator can be charged.

The fixing parts for wall mounting or mounting into a vehicle ensure a safe position of the PRIMEDIC

™

Defi-Monitor when inserting into the charging unit. Hold the handle of the defibrillator and press down release button (66) with your

™

index to remove the PRIMEDIC

Defi-Monitor from the charging unit. Now the defibrillator can be removed or tilted downwards in order to reach the second accumulator.

Note:

After insertion check whether the defibrillator is locked firmly.

Caution:

™

Accu

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Instructions for use PRIMEDIC

9. Handling of the changeable

The changeable accumulator (PRIMEDIC™ Accu) is charged automatically when inserting the defibrillator into the charging unit. In case of permanent use of the PRIMEDIC Defi-Monitor one or more charged accumulators have to be kept available for use in case of emergency. The comfort version (optional) of the charging unit (see section 9.2) allows the charging of an additional accumulator.

All accumulators based on NiCd technics have to be discharged completely before recharging in order to avoid a "memory" effect (see appendix A1).

The comfort version of the charging unit ensures best accumulator care. For the charging of a second accumulator it is equipped with the so-called Accu-Care function that checks the inserted accumulator and discharges it completely before charging the maximum capacity.

The "memory" effect can be avoided effectively by regular exchange of the accumulator connected to the PRIMEDIC

Defi-Monitor for the second accumulator of the charging unit (approx. every second week).

Note:

Accumulators are subject to wear. Even best care does not avoid a derating of capacity in the long run. Stop using the accumulator if after approx. 2 years the accumulator capacity only allows few shocks with maximum energy.

Note:

Accumulators have to be disposed of professionally. Return the used PRIMEDIC dispose of the accumulators in the household garbage!

Note:

Insertion of the defibrillator with discharged accumulator into the charging unit allows monitoring operation immediately after switching on.

Attention:

To operate the PRIMEDIC has to be connected to the right side of the casing. This is also necessary for safety reasons for the operation of the defibrillator when it is inserted into the charging unit.

™

Defi-Monitor ECO 1 / DM 1 / DM 3

accumulator

™

Accus to us or to the dealer. Do not

™

Defi-Monitor the accumulator

™

90 19499 / 05.03

Instructions for use PRIMEDIC

9.1 Changing of the accumulators

Connect the PRIMEDIC™ Accu to the defibrillator as follows:

1. Remove the right paddle cable (apex) from its rest position

2. Take the PRIMEDIC

3. Put the accumulator in the guide provided from the side.

4. Move the accumulator upwards until it engages audibly.

Note:

The PRIMEDIC casing while moving upwards until it engages. Oblique insertion of the accumulator is not possible.

Remove the PRIMEDIC follows:

1. Remove the right paddle cable (apex) from its rest

2. Press down the marking on the release button (7) and

5. Move the accumulator downwards while it is sitting

4. Release the release button (7).

9.2 Parallel accumulator charging in the

™

Defi-Monitor ECO 1 / DM 1 / DM 3

to facilitate locking of the accumulator.

™

Accu with the connection contacts

showing to the top. Ensure that it sits close to the defibrillator side and is

perfectly aligned in its lowest position.

™

Accu must sit close to the defibrillator

™

Accu from the defibrillator as

position to facilitate changing of the accumulator. keep the button pressed down.

closely to the defibrillator until it disengages audibly.

charging unit

Charging of a second PRIMEDIC™ Accu is only possible with the comfort version of the charging unit.

™

Insert the PRIMEDIC

Accu into shaft (51) of the charging unit with the contacts showing downwards. Insert from top to the bottom.

If the charging unit is mounted e. g. at the wall and the defibrillator is inserted, you can still insert or remove the second accumulator. To do so press release button (66) and tilt the defibrillator to the front until access to the shaft is possible.

19499 / 05.03 91

Instructions for use PRIMEDIC

After insertion the accumulator capacity is indicated. All three Accumulator LEDs (54-56) in the charging base (52) light up. Then the accumulator is completely discharged which is indicated by the flashing of LEDs (54-56).

At the end of the discharging the accumulator is charged completely. LED (53) flashes to indicate the charging. When charging of the PRIMEDIC off and the 100 % LED (54) lights up. Remove the accumulator. The charged capacity remains should the accumulator sit on the charging unit for a longer period.

Note:

Do not remove the accumulator from the shaft during charging or discharging.

10. Maintenance and care

™

Defi-Monitor ECO 1 / DM 1 / DM 3

™

Accu is finished LED (53) goes

For maintenance of the PRIMEDIC™ Defi-Monitor, all accessory parts such as ECG patient cable and the charging

™

unit PRIMEDIC

Defi-Charger we recommend a commercial domestic cleaner. Use a wet, clean cloth for cleaning.

Use a commercial disinfectant (e. g. Gigasept FF) for disinfection of the paddle electrodes.

Attention:

Do not use soaking wet clothes for cleaning. Do not pour any liquids over the device and do not plunge it into water.

Regardless of the use of the device, we recommend visual inspections / maintenance of the PRIMEDIC

™

Defi-Monitor

and the accessory parts to be carried out by the user.

Pay attention to the following:

1. Check whether the parts of the casing are damaged

(defibrillator, charging unit, accumulator).

2. Check whether the insulation of the ECG patient cable and

the paddle cable is damaged.

3. Remove remaining gel and impurities from the paddle

electrodes in order to ensure safe contact between children's paddles and paddles for adults and to prevent sparking voltage.

4. Remove dirt accumulated in the shaft.

Attention:

Damaged parts of the casing and insulations have to be repaired immediately.

92 19499 / 05.03

Instructions for use PRIMEDIC

11. Waste Treatment

At the end of its useful life, the unit must be recycled in accordance with the relevant local regulations. In case of doubt, please request details from the local recycling company.

™

Defi-Monitor ECO 1 / DM 1 / DM 3

19499 / 05.03 93

Instructions for use PRIMEDIC

™

Defi-Monitor ECO 1 / DM 1 / DM 3

12. Technical data, accessories, symbols

12.1 Technical data PRIMEDIC™ Defi-Monitor ECO 1 / DM 1 / DM 3

Defibrillation / cardioversion:

Operating modes: synchronous or asynchronous, external defibrillation Energy steps: 10, 20, 30, 50, 100, 200, 300, 360 joule (50 Ω) Discharges: 60 with 360 joule at 20 °C, 30 with 360 joule at 0 °C Charging time, accumulator charged: 1 s (100 joule), 5 s (360 joule) Charging time after 15 shocks: 1.5 s (100 joule), 5.5 s (360 joule) Delay time: < 60 ms between synchronization pulse and energy

discharge

EKG-Monitoring Modell ECO 1:

Construction: ECG monitor movable by ± 30° for easy reading of ECG Monitor type high resolution graphic EL monitor (electro-luminescence) Monitor size: 120 x 90 mm (diagonal 5,7” or145 mm) Resolution: 320 x 240 pixel (pixel size 0.36 x 0.36 mm) Filter: connectable, 50 or 60 Hz Functions: signal amplification, systole beep, heartrate, paddle lead, energy step,

accumulator capacity, heartalarm limits,

Alarm: variable for high and low heartrates

EKG-Monitoring DM 1 / DM 3:

Construction: ECG monitor movable by ± 30° for easy reading of ECG Monitor type high resolution graphic EL monitor (electro-luminescence) Monitor size: 115 x 86 mm (diagonal 143 mm) Resolution: 320 x 240 pixel (pixel size 0.36 x 0.36 mm) Filter: connectable 50 or 60 Hz Functions: signal amplification, heartrate, lead, energy step, accumulator capacity,

heartalarm limits, SpO

Alarm: variable for high and low heartrates or SpO

NELLCOR®-pulsoximetry-module:

Indication range: 100 ... 0 % Calibration range: 100 ... 50 % Measurement precision: SpO

Adults 100 ... 70 % +/- 2 digits 69 ... 50 % +/- 3 digits 50 ... 0 % not specified New-born 95 ... 70 % +/- 3 digits

For information about test procedures for the calibration ask manufacturer. Wavelength: Red: 660 nm

Infrared: 920 nm Light density: 0,5 lumen/cm

Operating mode: continuous Actualisation time: < 2 sec.

Information related with toxicity of the materials getting into contact with the patients 18565 Fingersensor DS.100A for pulsoximeter EN10993-10, ISO 10993-5

value, SpO2 alarm limits (SpO2 only with DM 3)

(SpO2 only with DM 3)

94 19499 / 05.03

Instructions for use PRIMEDIC

™

Defi-Monitor ECO 1 / DM 1 / DM 3

Printer:

Printer type: thermal transfer head, 1-channel Resolution: 8 bit / 200dpi Paper width: 58 mm Operating modes: auto print (protocol printing showing the events of the 5 s before and 5 s

after defibrillation) ECG print (EKG on-line protocol printing) MEMO-print (printing of the saved events of the last 10 defibrillations with

5 s before and 5 s after defibrillation)

1/3-canal print

*only model DM1 and DM3

Safety:

Classification: Protection type II, Type BF, Medical device class 2b

Regulatory affairs:

0123

The product is a medical device according to EC guideline 93/42/EEC.

Other data:

Power supply: by changeable accumulator (PRIMEDIC Changeable accumulator: 14.4 V / 1.5 Ah / NiCd Operating conditions: 0 ... 50 °C, 30 ... 95 % rel. humidity, but without condensation

700 hPa ... 5000 hPa for 1 h, 700 hPa ... 1060 hPa continuous service

Storage environment: -20 ... 70 °C, 20 ... 95 % rel. humidity, but without condensation 500 hPa ... 1060 hPa

Dimensions: 42 x 12 x 42 cm (w x d x h) Weight: 8 kg

Subject to alterations.

™

Accu)

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Instructions for use PRIMEDIC

™

Defi-Monitor ECO 1 / DM 1 / DM 3

Delivery specification: Part no.

™

PRIMEDIC

Defi-Monitor ECO 1 96017

™

1 PRIMEDIC

Accu, 14,4 V / 1,5 Ah, NiCd 72264 1 ECG patient cable, 4-lead, neutral electrode (3+N) 72303 30 ECG-electrodes Ag/AgCl Ø 55 mm, with push button, single use 18155 1 conductive gel, 60 g 13026 1 Printer paper, 58 mm, 25 m 18122 1 Medical device protocol 13084 1 Instructions for use 19094 1 Briefing protocol 18514

PRIMEDIC

™

Defi-Monitor DM 1 96088

see ECO 1

PRIMEDIC

™

Defi-Monitor DM 3 90067

see DM 1, but additional 1 SpO

1 SpO

fingersensor DS-100 A (NELLCOR

patient cable (2.4m) 18783

) 18565

12.2 Accessories

Part no. Bag with three transparent storage compartments 72310

Shoulder strap with fixation kits incl. shoulder pad 18578 conductive gel, 60 g 13026 ECG patient cable, 4-lead, neutral electrode (3+N) 72303 ECG-electrodes Ag/AgCl Ø 55 mm, with push button, single use 18155

PRIMEDIC

More accessories see separate accessories / price list.

™

Accu, 14.4 V / 1.5 Ah, NiCd 72264

96 19499 / 05.03

Instructions for use PRIMEDIC

™

Defi-Monitor ECO 1 / DM 1 / DM 3

12.3 Symbols

The following symbols are used on the device:

Rating plate:

IPX1

Paddle:

Protection type

Splash-proof

Comply with instructions for use!

Degree of protection BF, input with defibrillation protection

Hazardous electric voltage (high voltage)

ECG input socket:

Degree of protection CF, input with defibrillation protection

SP02 input socket: (only model DM 3)

Degree of protection BF; input with defibrillation protection. Comply with instructions for use!

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Instructions for use PRIMEDIC

™

Defi-Monitor ECO 1 / DM 1 / DM 3

13. Conditions of Guarantee

As the manufacturer, METRAX grants a guarantee on this device for 2 years starting with the date of purchase. During this period, METRAX will eliminate any defects in the device, resulting from material faults or manufacturing faults, free-of-charge. Elimination of defects is made by METRAX either by repair or by replacement. Any repair carried out during the guarantee period shall not extend the original guarantee period.

The right to claim under guarantee and damage claims provided by law do not apply in case of only immaterial impairment of usefulness, natural wear or damages, produced after liability transfer to the buyer, as a result of wrong or negligent use, excessive stress or caused by extreme external influences not covered by the terms of agreement. The same applies if the buyer or third parties perform modifications or repair work in an unprofessional manner.

Further contractual and non-contractual claims against METRAX are excluded unless such claims are based on intent or on severe negligence or on compelling liability regulations provided by law.

Claims for damages by the buyer against the seller (trader) remain unaffected by this guarantee. In case of claims under guarantee, you are asked to send the device including a buyer’s certificate (e.g.

a bill), stating your name and address, to your dealer or to METRAX. The METRAX-customer service will be glad to assist you even after the guarantee period has expired !

98 19499 / 05.03

Instructions for use PRIMEDIC

™

Defi-Monitor ECO 1 / DM 1 / DM 3

14. Appendix A1 General instructions and rules for the use of accumulators

What is an accumulator?

Accumulators are used for storing electric energy. During the charging procedure the charge current is stored in the accumulator by a chemical process. When the accumulator is discharged (during operation) the chemical energy is converted back into electric energy. This charging and discharging process can be repeated several times.

Lead-acid or NiCd-accumulator?

Various accumulator designs with different and typical features proved in practice.

1. Lead-acid accumulator

2. NiCd-accumulator (nickel-cadmium)

3. metal-hybrid accumulator The development of the PRIMEDIC

revealed advantages over other constructions. The lead-acid accumulator, one of the first accumulator types, converts the energy to hazardous

oxyhydrogen gas (explosion hazard) when the charge is too strong. Compared to the lead-acid accumulator the NiCd-accumulator has got a considerably higher energy density. This means that the

PRIMEDIC

™

Accu of the same size can release far more shocks (i. e. has a longer monitoring time)

than a comparable lead-acid accumulator. The metal-hybrid accumulator has even got a higher energy density than the NiCd-accumulator but the

current level delivered by this accumulator is too low. This would cause a too long supply time of energy required for the shock which contradicts the requirements of today's defibrillators.

The handling of the NiCd-accumulator is easy. State-of-the-art microprocessor-controlled charging circuits, also used in the PRIMEDIC longer service life of the accumulator.

Partial discharging and recharging of the NiCd-accumulator over a longer period lead to the typical phenomenon, the "memory" effect. Due to the "memory" effect the accumulator operates like a small accumulator with low capacity although it has got a nominally large accumulator capacity.

Example:

An accumulator has a capacity of 60 shocks with 360 joule each. Energy for 5 shocks will be released and the accumulator recharged. This procedure, if continued over a longer period, can cause the "memory" effect. This means that the accumulator capacity will be reduced to 5 to 6 shocks since the accumulator is "trained" on 5 shocks.

It is very difficult to eliminate the "memory" effect, i. e. to get back to the full capacity, if the "remaining capacity" remains under a practicable value.

™

Defi-Monitor is based on the NiCd-accumulator since practice

™

Defi-Monitor allow to realize very short charging times and a

19499 / 05.03 99

Instructions for use PRIMEDIC

™

Defi-Monitor ECO 1 / DM 1 / DM 3

How to avoid the "memory" effect?

The "memory" effect can be avoided by discharging the accumulator completely from time to time so that a complete charging can be carried out. There are various possibilities for the practice:

1. Do not immediately recharge the accumulator if it has only been discharged slightly. In most

cases sufficient energy is available for later applications. The PRIMEDIC not always recharge the accumulator immediately. The accumulator is recharged only after falling below a limit.

2. Before charging the accumulator use the remaining capacity for e. g. several shocks with high

energy or for monitoring. This is not necessary every time before charging but only from time to time (every week or month, depending on the use).

3. Best accumulator care is obtained by means of the fully automatic discharging / charging unit

which carries out a defined discharging before every charging procedure. For safety reasons, this charging process is not used with accumulators being charged directly in the defibrillator. The worst case could be that the defibrillator is required just when the accumulator is completely discharged. .

The fully automatic discharging / charging, i. e. the Accu-Care function is integrated in the

charging unit of the PRIMEDIC charge a second PRIMEDIC

™

Defi-Monitor. This option (retrofitting possible) allows to

™

Accu and to avoid efficiently the "memory" effect by means of the

Accu-Care function.

Further effects of accumulators?

In daily practice, accumulators have two further features:

1. Self-discharge

2. Aging after a longer period of use. In practice self-discharge means that a full accumulator is subject to a slow but continuous loss of

charge. After approx. 4 weeks 90 % of the capacity are available. This effect, however, is only important if several charged accumulators are kept "on stock".

The PRIMEDIC

™

Defi-Monitor is equipped with a circuit for conservation of the charge.

Even best maintenance of the accumulator does not avoid an aging after approx. 2-3 years (depending on the use). After approx. 500-1000 charging cycles (depending on the type) it is impossible for the accumulator to transfer the electric energy charged to the chemical storage. Thus the accumulator becomes unusable and has to be replaced for a new one.

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Defi-Monitor does

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A2 General instructions and rules for the handling of defibrillators

What is a defibrillator?

During defibrillation current is delivered to the heart muscle. The contraction caused and the depolarization of the heart muscle eliminate dangerous cardiac irregularity.

Cardiac irregularity means uncoordinated electric and mechanical activities of the heart muscle.

Dysrhythmia possible measures

partly uncoordinated activities of the heart muscle (e. g. atrial fibrillation)

completely uncoordinated activities of the heart muscle (ventricular flutter)

The a. m. table shows two general groups of cardiac irregularity and the possible counter-measures. The procedure of the two cardioversions are different and described in the following:

1. Unsynchronized cardioversion (defibrillation): With this procedure energy is released immediately as soon as the keys for "shock release" are

pressed. This procedure requires the clear and definite establishment of the diagnosis "ventricular flutter or pulse missing".

Asynchronous supply of energy to the cardiac rhythm by the defibrillator can cause damages to the heart. If the energy is supplied to the heart muscle during the ventricular refractory period (approx. first half of the T-wave) the heart is susceptible to ventricular fibrillation.

2. Synchronized cardioversion: For the application of this procedure it is essential that the patient has got a discernible heart

rhythm. A clear QRS complex in the ECG is required for the synchronous shock release. Controlled by the synchronous mechanism of the ECG unit, the shock is released a few milliseconds (about 10-30 ms) after detection of the R-peak.

The ECG unit marks the detected QRS complex with a "SYNC" marker serving as aid for the doctor in charge.

The best "care" of the doctor releasing the shock is indispensable during this procedure. He has to watch the ECG signal on the monitor continuously and ensure that every QRS complex is detected and no artefacts or pacemaker pulses are synchronized.

synchronized cardioversion

unsynchronized cardioversion (defibrillation)

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Procedure for defibrillation (unsynchronized cardioversion):

The steps for defibrillation described in the following apply for the handling of the defibrillator only. The area of the mechanical, cardiopulomary or pharmacological resuscitation is not described.

The procedure of the unsynchronized cardioversion must only be applied in case of ventricular fibrillation, i. e. P- and T-waves as well as QRS-copmlexe missing in the ECG of the patient.

1. Switch on defibrillator and ECG unit.

With the PRIMEDIC

2. Make sure that the defibrillator is not in synchronous mode. With the PRIMEDIC Even after release of a shock in synchronous mode it switches back to asynchronous mode.

3. Apply electrode gel to paddle electrodes.

Apply sufficient electrode gel on the paddle electrodes to limit the contact resistance so that the energy can be released completely to the patient. Insufficient contact gel may cause that the skin under the electrodes gets burnt. Do not spread the electrode gel on the handles of the paddles, otherwise energy may flash over to the doctor in charge of the defibrillation.

4. Select energy.

The energy to be released depends on the patient's body height and weight. The following rule of thumb applies: 2 joule per kg body weight. The most suitable energy is based on experience and depends on the emergency situation.

5. Positioning of the paddles.

Stick the paddles firmly to the bare chest of the patient by applying a pressure of approx. 100 N to ensure perfect energy transfer. Applying not enough pressure may cause that the skin under the electrodes gets burnt. Applying correct pressure should be trained on devices provided for that purpose.

The position of the paddles decides on the success of the resuscitation. The flow of current between the paddles through the chest has to flow through a large part of the tissue of the heart muscle. The chance to eliminate the ventricular fibrillation only exists when the "critical mass" of about 80 % of the heart is perfused sufficiently.

In case of incorrect paddle position most of the current misses the heart and is thus ineffective.

Position of the sternum paddle: - right chest area

- right close to sternum

- below the clavicle

Position of the apex paddle: - left, lower chest area

- above apex of the heart

- midaxillary line

Make sure that no electrode gel has been spread between the paddles on the patient's chest. Otherwise the current flows on the surface between the paddles. Do not spread the electrode gel on the handles of the paddles, otherwise energy may flash over to the doctor in charge.

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Defi-Monitor the ECG unit is also switched on automatically.

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Defi-Monitor the defibrillator always starts in asynchronous mode.

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6. Energy charging.

After charging the energy remains available for a limited time, i. e. 15 seconds with the

PRIMEDIC

of seconds. If no shock is released during this time the energy is discharged internally for safety reasons and has to be recharged afterwards.

7. Protection against electric shock.

Before defibrillating the doctor releasing the shock has to ask all persons attending to the

resuscitation clearly and unmistakably to step back from the treatment location and to touch neither the patient nor the bed nor the connected devices. Remove any devices without defibrillation protection from the patient before releasing the shock. Otherwise energy may flash over to persons in unfavourable situations.

8. Discharge energy (shock).

Discharge the defibrillator by pressing both release buttons on the paddles simultaneously.

9. Check the result.

Check the condition of the patient and the ECG monitor after defibrillation. Depending on the

result of the defibrillation further defibrillations in quick succession might be necessary (repeat steps 4 - 9).

The emergency physician may ask for accompanying manual or pharmacological measures.

10. Keep the defibrillator ready for use.

Clean the paddles, cable and electrodes at the end of the resuscitation to ensure availability of

the defibrillator for the next application. Insert the defibrillator into the charging unit to charge the accumulator in order to ensure that sufficient energy is available for the next use.

Functional disorders or faults have to be checked or if required rectified immediately by an

authorized service technician.

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Defi-Monitor. This time is also shown on the monitor and counted down in steps

Procedure for synchronized cardioversion The steps described in the following apply for the handling of the defibrillator only. Alternative or

supporting treatments are not described. The synchronized cardioversion must only be applied if a clear QRS complex is available. The

synchronized cardioversion can be applied for treatments of cardiac irregularity such as atrial fibrillation / atrial flutter, ventricular tachycardia with pulse or supraventricular tachycardia.

1. Prepare the patient for synchronous cardioversion. For most cardioversions sufficient time is available (selective treatment) which allows to prepare

the patient for the treatment:

a) ask the patient for written consent (and inform the patient), b) no food intake (6-10 hours before beginning with the treatment), c) light sedation of the patient (preparing for anesthesia), d) sedation of the patient, perhaps intubation (controlled by an anesthetist)

Exception: The emergency cardioversion (e. g. supraventricular tachycardia) requires only the sedation of the patient.

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2. Switch on defibrillator and ECG unit.

With the PRIMEDIC

3. Connect the ECG electrode cable, carry out the ECG.

Connect the external ECG electrode cable to the ECG defibrillator / unit and position the

patient's electrodes safely at the respective lead positions. Select the corresponding standard leads at the monitor. Check whether "usable" signals from all standard leads are shown on the monitor in order to verify the correct contact of all electrodes.

The most suitable lead for synchronized cardioversion is in most cases the standard lead II. Any

other lead showing a clear R-peak can be used as well.

A clear R-peak is important for a reliable synchronization. Watch the monitor and "optimize" the

ECG graph if required by changing the signal amplification. A weak ECG signal can generate a good synchronous signal by amplifying it (e. g. 2 cm/mV). An overloaded ECG signal can reduce the reliability, i. e. weaken the signal if required (o.5 cm/mV.

Use another lead if required or change the position of the patient's ECG electrodes slightly.

Never select the paddle lead since slight movements (artefacts) can misroute the synchronous signal.

4. Switch the defibrillator to synchronous mode.

During synchronized cardioversion the defibrillator must work in synchronous mode.

Asynchronous operation may be life-threatening for the patient.

Verify several times that synchronous mode is activated by watching the monitor (plain text

display: "SYNC" and SYNC markings on the ECG) as well as the lighting up of the LED located above the SYNC key (with PRIMEDIC back to asynchronous mode after every synchronized cardioversion, i. e. that it definitely switches on the SYNC mode before any further synchronous cardioversion.

5. Check ECG signals.

Every R-peak must supply a synchronous signal in order to obtain a reliable synchronized

cardioversion. Artefacts and pacemaker pulses must not show synchronous markings. Check the ECG signal permanently and make sure that every R-peak shows a SYNC marker.

If not, change the amplification as described under item 3, select another lead or change the

position of the ECG electrodes.

In case of intensive tachycardia it is possible that only every second R-peak shows a SYNC

marker. That is no reason to be alarmed since not every R-peak must be marked but every SYNC marker must be related to a R-peak. .

6. Apply electrode gel to paddle electrodes.

Apply sufficient electrode gel on the paddle electrodes to limit the contact resistance so that the

energy can be released completely to the patient. Insufficient contact gel may cause that the skin under the electrodes gets burnt.

Do not spread the electrode gel on the handles of the paddles, otherwise energy may flash over

to the doctor in charge of the defibrillation.

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Defi-Monitor the ECG unit is also switched on automatically.

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Defi-Monitor). Consider that the defibrillator switches

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7. Select energy.

The energies required for synchronized cardioversion are in most cases lower than for

defibrillation (unsynchronized cardioversion) as it is not necessary to depolarize all heart muscles.

The energy depends roughly on the patient's body height and weight. The indications, however,

determine the energy, i. e. the following empirical values are applicable: Ventricular tachycardia with unstable pulse: 50 joule, further cardioversions to be increased by

approx. 50 joule each (100 j, 160 j, 200 j, ...) Supraventricular tachycardia: 50-100 joule Atrial flutter: 20-50 joule Atrial fibrillation: 100 joule

If ventricular fibrillation arises from the treatment immediate defibrillation in asynchronous mode

at adjusted and higher energy is necessary.

8. Positioning of the paddles.

Stick the paddles firmly to the bare chest of the patient by applying a pressure of approx. 100 N

to ensure perfect energy transfer. Applying not enough pressure may cause that the skin under the electrodes gets burnt.

The position of the paddles decides on the success of the resuscitation. The flow of current

between the paddles through the chest has to flow through a large part of the tissue of the heart muscle. The change to eliminate the ventricular fibrillation only exists when the "critical mass" of about 80 % of the heart is perfused sufficiently.

In case of incorrect paddle position most of the current misses the heart and is thus ineffective.

Position of the sternum paddle: - right chest area

- right close to sternum

- below the clavicle Position of the apex paddle: - left, lower chest area

- above apex of the heart

- midaxillary line Make sure that no electrode gel has been spread between the paddles on the patient's chest.

Otherwise the current flows on the surface between the paddles. Do not spread the electrode gel on the handles of the paddles, otherwise energy may flash over to the doctor in charge.

9. Energy charging After charging the energy remains available for a certain time, i. e. 15 seconds with the

PRIMEDIC

of seconds. If no shock is released during this time the energy is discharged internally for safety reasons and has to be recharged afterwards.

10. Check ECG signal. See item 5.

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Defi-Monitor. This time is also shown on the monitor and counted down in steps

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11. Protection against electric shock.

Before defibrillating the doctor releasing the shock has to ask all persons attending to the

12. Discharge energy (shock).

Prepare the defibrillator for the shock by pressing the release buttons on the paddles

simultaneously. Keep the buttons pressed down. The shock is released by the ECG as soon as the next R-peak is recognized. In case of quick pulse the shock may follow shortly after pressing the release buttons simultaneously. A slow pulse may cause an evident delay in time. In this case do not reduce the pressure of the paddles on the patient's chest. Keep the release buttons pressed down and check the ECG. If no shock follows after several seconds, release the release buttons before taking the paddles off the chest.

With the PRIMEDIC

the release buttons pressed down for more than three seconds and no shock is released during this time (no R-peak available / detected). After the internal safety discharge the PRIMEDIC

Defi-Monitor is available for the next defibrillation in asynchronous mode.

13. Check the result.

Check the patient's heart rhythm, breathing and condition after the synchronous cardioversion.

Check the ECG and decide whether a further trial is necessary. If yes, repeat steps 4 to 13.

Please consider that nearly all defibrillators on the market (PRIMEDIC

included) switch back to asynchronous mode automatically after a synchronous shock has been released.

Control the heart rhythm over a certain time after successful cardioversion.

14. Keep the defibrillator ready for use.

Clean the paddles, cable and electrodes at the end of the resuscitation to ensure availability of

the defibrillator for the next application. Insert the defibrillator into the charging unit to charge the accumulator in order to ensure that sufficient energy is available for the next use.

In case of malfunctions or faults have the defibrillator checked immediately and if necessary

repaired by an authorized service technician.

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Defi-Monitor an internal safety discharge is carried out when keeping

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Defi-Monitor

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A3 General instructions for the use of pulsoximeters

What is pulsoximetry?

A pulsoximeter determines the SpO method is based on the penetration of light of different wavelengths through tissues and vessel.

The components of blood important for the SpO deoxygenated (without oxygen) haemoglobin, i.e. exactly the components necessary for oxygen supply of the organism.

The tissues and vessels are “penetrated by light“ with the help of transmitter-receiver elements. Depending upon the oxygen saturation of the blood the quantity of light arriving on the receiver side of the transmitter changes. Thanks to the application of precise modules and calibrated sensores, highly exact SpO

measures are possible.

Usual measure points for the sensors are

• finger tips

• tows

• earlobes

• heel

Why are there different sensors?

As described in, among others, chapter 6.2 (selection of the correct SpO have to be used for different patients to guarantee reliable and exact measures.

The following factors have to be taken into account:

• weight of the patient

• activity of the patient

• duration of the measure

• blood circulation in the limbs

• possible measuring point

• physical condition of the patient

• sterile measure necessary?

Evidently no single sensor can meet all the, to some extent contradictory, requirements. The different SpO

sensors are designed for specific purposes.

As an example may serve the sensor DS-100 A or the D-YS respectively from NELLCOR allows rapid handling and it is simple to be slipped on fingers of different thickness thanks to its sophisticated mechanism. But it is not suitable for children because of its geometry. Using this sensor for patients who move a lot is also not possible, as, due to the design of the casing the sensor might slip off the patients finger. As the D-SY has no casing this sensor D-SY may be applied for higher weight classes, moreover it might be positioned with more flexibility and can fixed with an adherent strip, which reduces the rapid positioning of this sensor.

value (oxygen saturation) by optical measuring methods. This

measuring, are oxygenated (oxygen-enriched) or

sensor) different sensors

. DS-100 A

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Which factors influence the SpO2 measure?

As the measuring of the oxygen saturation is an optical method, the following influencing factors might affect the results:

• direct sun light

• strong artificial light (e.g. operating room lighting)

• infrared lamps

• ultraviolet lamps (bilirubin lamps)

The influence of the above mentioned factors can be reduced positioning the sensor correctly and using covers of the sensors.

More influencing factors are:

• dirty measuring point

• incorrect cleaning of the sensor

• opaqueness or colour distortion at the measuring point e.g. by nail-varnish

• highly active patient

• injected contrast media, (e.g. indiocyanide green or methylene blue)

• high proportions of dysfunctional haemoglobin (carboxy haemoglobin)

• wrong point of positioning (e.g. point with venous pulse)

• use of the pulsoximeter close to strong source of energy like e.g. nuclear spin tomograph

• sensor applied too rigidly

• arterial occlusion close to the sensor

• blood congestion e.g. by artery catheter or by sphygmomanometer

Some of these factors are easy to recognize (e.g. nail-varnish) and are removable; a repeatable result can be obtained at a different measuring point.

Other factors (e.g. contrast media or blood serum disorder) are not as easy to be determined. The SpO

multitude of influencing factors. More parameters must always be monitored (e.g. ECG, blood pressure, respiration ...).

The SpO used correctly, the specific warnings and hints on the use of the sensor are observed and the clinical symptoms are taken into consideration.

measure should not be the only method applied to monitor the vital functions due to this

measure can be an important instrument for the diagnosis of patients, when the sensor is

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A4 Voltage - time graphs

Please find in the following the graph shapes of the defibrillation pulses depending on the terminal resistance.

1. Graph shape with 25 Ω

U = 2.280 V 2 ms / div.

2. Graph shape with 50 Ω

U = 2.940 V 2 ms / div.

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3. Graph shape with 100 Ω

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Defi-Monitor ECO 1 / DM 1 / DM 3

U = 3.180 V 2 ms / div.

4. Graph shape with 125 Ω

U = 2.800 V 2 ms / div.

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A5 Description of monitor screen and printouts

Reference:

operating mode: synchronous lead: aVL selected energy: 360 joule heartrate: 92 / min upper alarm limit: 150 / min lower alarm limit: 30 / min upper SpO lower SpO signal amplification: 2 cm/mV accumulator capacity: 80 - 100 %

alarm 100 %

alarm 80 %

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Printout of the ECG in synchronous mode with synchronous markers, 1-channel, 25 mm/s printing speed

Printout of the ECG in asynchronous mode, 3-channel, 50 mm/s printing speed

Printout of the ECG, 1-channel, 25 mm/s printing speed, with SpO

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Monitor screen during set-up with example settings

1. Page

Filter 50 Hz Date (dd.mm.yy) 05 . 03 . 97 Time 13 : 20 Language English Autoprint ON Print 3-Channel Print 25 mm/s Memo Print activate

-> Alarms End Setup

2. Page

ALARM

Alarm 1 30 150 Alarm 2 40 160 Alarm 3 50 180 SpO2 Alarm 1 85 100

ALARM

SpO2 Alarm 2 80 100 SpO2 Alarm 3 70 90

End Setup

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A6 Safety control

According to Medizinprodukte Betreiberverordnung (MPBetreibV) § 6 (safety controls) and § 11 (measurement controls) users of defibrillators are obliged to have the devices controlled. According to MPBetreibV § 6 METRAX has prescribed controls in 12 months cycles.

The safety controls must be carried out only by persons qualified by their training, their knowledge and experience gained in practice to execute controls professionally and not receiving any instructions for the controls.

If the safety control reveals any defect that represents a hazard for patients, employees or third parties, the responsible authority has to be informed immediately by the user according to MPBetreibV § 3.

In accordance with MPBetreibV § 7 the following data has to be entered in the medical devices protocol accompanying the device:

• Time when the work was carried out

• Name of the person or company who/which carried out the work and

• the work carried out.

METRAX can be held responsible for the contents of the operating manual only. This especially applies to new settings, commissioning and modifications to the device.

In the rotational control the following work and checks have to be undertaken by a service technician:

1. Check whether the device shows external damages

• Casing deformed?

• Paddle cable, ECG patient cable, SpO

• ECG input socket, SpO

input socket (*) damaged?

• Paddle damaged?

• Paddle for adults available and attached?

• Rating plate on the back of the device legible?

patient cable (*) damaged?

2. Check whether operating elements are damaged

• Membrane keyboard legible?

• Membrane keyboard damaged?

3. Check the indicating elements

• all LEDs are active for approx. 2 second after switching on the defibrillator?

• the LED allocated to the selected energy step lights up (check all energy steps once)

• LED (33) lights up after pressing "SYNC" (34)?

• the warning buzzer goes on for approx. 2 second after switching on the defibrillator?

4. Measure the charging time.

• Charging time for 360 joule when the accumulator is full less than 7 seconds? Procedure for the test:

1. Press key for 360 joule.

2. Press paddle release (10) or (12).

3. Start stop watch simultaneously.

4. Energy charging finished when the green OK LED (41) lights up.

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5. Measure the output power.

the checking of the defibrillation energy with 50 Ω the following tolerances are allowed:

• at 20 joule ± 4 joule

• at 50 to 360 joule ± 15 %

All energy steps from 10 to 360 joule are measured.

6. Functioning of the ECG monitor.

• Is the selected energy displayed on the monitor? Press one or several joule keys (32).

• Is the synchronous operation displayed on the monitor? Press SYNC (34).

• Is the SpO

socket (16).

Feed an ECG signal with known frequency coming from the ECG simulator via the patient cable.

• Systole beep can be switched on and off (key 24)?

• Heartrate indicated with a tolerance of ± 10 %?

• All leads can be selected and are displayed (key 22)?

• ECG signal can be represented with 0.5 cm/mV or 2 cm/mV (key 23)?

• After pressing SYNC (34) synchronous markers related to the R-peaks appear?

Activate one of the three heartrate alarms (key 28) and switch off the ECG simulator.

• Heartrate alarm goes on?

• After acknowledgement of the alarm (pressing of ALARM (28)) heartrate alarm goes on once

more for about 60 seconds?

value displayed? (*) Insert the NELLCORETM sensor and the SpO2 patient cable into

7. Functioning of the pulsoximeter (*)

Insert NELLXOR sensor DS-100 A and SpO function put index finger into the sensor or connect a SpO

• Is a SpO

value displayed?

patient cable into the socket (16). To control the

test advice to the SpO2 patient cable.

• Is the pulse curve displayed?

• Is an error message displayed when the SpO

patient cable is pulled off?

8. Functioning of the printer.

Feed an ECG signal coming from the ECG simulator via the patient cable.

• On-line printing follows after pressing PRINTER ON / OFF (39).

• Choose a different printing speed in the set-up menu (except DM 1), check if the printing

speed is identical with the preset speed?

9. Functioning of the accumulator / charging unit.

Charging LED (57) flashes for at least 1minute after inserting the defibrillator into the charging unit.

10. Measuring of the patient's lead current according to IEC 601-1.

1. Paddle lead selected (key 21) and measurements for type BF performed

2. Standard lead selected (key 22) and measurements for type CF performed

(*) = only if the corresponding option is installed in the device. Pulsoximeter is integrated in model

DM 3.

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Specifications and Main Features

Frequently Asked Questions

User Manual