Primedic Defi-Monitor DM 1 Instructions For Use Manual Download Page 56 | Manualshive

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Primedic Defi-Monitor DM 1 Instructions For Use Manual Download Page 56

Instructions for use

PRIMEDIC

™

Defi-Monitor ECO 1 / DM 1 / DM 3

114

19499 / 05.03

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

2

patient cable (*) damaged?

•

ECG input socket, SpO

2

input socket (*) damaged?

•

Paddle damaged?

•

Paddle for adults available and attached?

•

Rating plate on the back of the device legible?

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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Summary of Contents for Defi-Monitor DM 1

Page 1: ...olume 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 eve...

Page 2: ...uctions 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 is registered trademark of METRAX GmbH D Rottweil ...

Page 3: ... could also result in wrong indications of oxygen saturation Do not use the SpO2 measure as single method to monitor the vital functions The instructions for the use of pulsoximeters have to be complied with appendix A3 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 PRIM...

Page 4: ...Instructions for use PRIMEDIC Defi Monitor ECO 1 DM 1 DM 3 62 19499 05 03 Fax 49 0 741 257 235 ...

Page 5: ...ith 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 modular plug to connect modules as e g pacer module I D module for internal defibrillation onl...

Page 6: ...ndard 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 SpO2 To activate alarm limits for low and high SpO2 values presettable in the set up menu 26 Key PAPER FEEDInsertion of printing paper 27 Key PRINTER ON OFF Switching ON OFF the ECG on line printing 28 Key ALARM To activate alarm limits fo...

Page 7: ...EAD 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 SpO2 To activate alarm limits for low and high SpO2 values presettable in the set up menu 26 Key PAPER FEEDInsertion of printing paper 27 Key PRINTER ON OFF Switching ON OFF the ECG on line printing 28 Key ALARM ...

Page 8: ... 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 ch...

Page 9: ...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 ...

Page 10: ...shing 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 ...

Page 11: ...l 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...

Page 12: ...e 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...

Page 13: ...peration to avoid removing the defibrillator from the charging unit without accumulator in case of emergency 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 Defi Monitor Lock the changeable accumulator at the provided and marked location from the side in its position see also sectio...

Page 14: ... Off 50 Hz 60 Hz 2 Date DD MM JJ 3 Time hh mm ss 4 Language deutsch english français espanol portugesh 5 Automatic printing On Off 6 Print 1 lead 3 lead 7 Print 25 mm 50 mm 8 Memo Print activate with installed software option only for DM 1 and DM 3 eligible The second page allows the following settings 1 Alarm 1 30 90 2 Alarm 2 40 130 3 Alarm 3 50 180 4 SpO2 Alarm 1 95 100 5 SpO2 Alarm 2 90 100 6 ...

Page 15: ...uring the setting of the menu parameters the defibrillator has to be used immediately because of an emergency the set up menu can be terminated immediately by pressing ENERGY 32 4 Operation of the defibrillator 4 1 Switching the defibrillator on and off self test Press ON STAND BY 30 shortly to switch on the PRIMEDIC Defi Monitor To switch off press ON STAND BY 30 for approx 2 secs During switch o...

Page 16: ...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 ...

Page 17: ...ssing 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 dischar...

Page 18: ...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 ...

Page 19: ...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 Electrodes with smaller electrode surface have to be used for the defibrillation of children The paediat...

Page 20: ...o switch back to lead via paddle electrodes press PADDLE LEAD 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 Defi Monitor during the monitoring Note The PRIMEDIC Defi Monitor switches off automatically when no ECG is shown or no key is press...

Page 21: ...3 Volume of systole beep 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 2 ALARM 1 30 90 3 ALAR...

Page 22: ...lect 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 Five different contrast settings are available Depending on the ambient temperature or brightn...

Page 23: ... 4 Make sure that there is no electrolyte gel on the adherent surface 5 Stick the electrodes to the skin of the patient by pressing the adherent surface firmly against the skin Positioning according to the table Positioning of electrodes with four wire cable with neutral electrode After use remove the disposable electrodes by pressing together the electrode bracket Do not apply used disposable ele...

Page 24: ...input socket 16 at the upper left of the casing for the SpO2 patient cable Proceed as follows 1 Insert into slot 16 the blue plug 17 of the patient cable about 1 4 m 2 Plug the NELLCOR sensor into the other end of the SpO2 patient cable until the traction relief engages 3 Test the perfect mechanical locking of the plug in connection To dismount the NELLCOR sensor from the SpO2 patient cable push t...

Page 25: ...tion Only use original NELLCOR sensors for SpO2 measures Other sensores could cause measuring errors or damage the SpO2 module Attention Always use original SpO2 patient cables which guarantee the perfect connection of NELLCOR sensors to the Defi Monitor Attention Avoid tensile load at the NELLCOR sensor or the SpO2 patient cable 6 2 Selection of correct SpO2 sensor In order to select the correct ...

Page 26: ...ur 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 Four steps are ...

Page 27: ... 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 SpO2 ALARM 25 until the desired message e g SpO2 ALARM is displayed on the monitor After a defibrillation the SpO2 ALARMs are automatically set OFF Note Test possibility for alarm circuit Select alarm limits with no patient connecte...

Page 28: ...yed additionally 3 channel print prints channel I II III or aVR aVL aVF simultaneously depending upon the lead displayed on the monitor 25 mm s printing speed The information is printed at 25 mm s 50 mm s printing speed The information is printed at 50 mm s As for device version DM 3 it is possible to print the SpO2 in protocol printing quality but only in the 1 channel mode Printing is started 3 ...

Page 29: ...nchronous operation Lead Heartrate Filter Signal intensification Lines for additional notes SpO2 value only model DM 3 Speed The auto print function can be switched on and off in the set up 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 functio...

Page 30: ...es SpO2 value only with model DM 3 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 i...

Page 31: ...own 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 A completely discharged battery has to be recharged for at least 45 minutes A too short charging duration may lead to a wrong i...

Page 32: ...d 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 aft...

Page 33: ... Remove the PRIMEDIC Accu from the defibrillator as follows 1 Remove the right paddle cable apex from its rest position to facilitate changing of the accumulator 2 Press down the marking on the release button 7 and keep the button pressed down 5 Move the accumulator downwards while it is sitting closely to the defibrillator until it disengages audibly 4 Release the release button 7 9 2 Parallel ac...

Page 34: ... 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...

Page 35: ...Monitor ECO 1 DM 1 DM 3 19499 05 03 93 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 ...

Page 36: ...ad 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 ampl...

Page 37: ...r defibrillation 1 3 canal print only model DM1 and DM3 Safety Classification Protection type II Type BF Medical device class 2b Regulatory affairs The product is a medical device according to EC guideline 93 42 EEC Other data Power supply by changeable accumulator PRIMEDIC Accu Changeable accumulator 14 4 V 1 5 Ah NiCd Operating conditions 0 50 C 30 95 rel humidity but without condensation 700 hP...

Page 38: ...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 SpO2 fingersensor DS 100 A NELLCOR 18565 1 SpO2 patient cable 2 4m 18783 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 patie...

Page 39: ...PX1 Splash proof Comply with instructions for use Paddle 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 ...

Page 40: ... 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 cla...

Page 41: ...re 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 acc...

Page 42: ...rs 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 Defi Monitor This option retrofitting possible allows to charge a second PRIMEDIC Accu and to avoid efficiently the memory e...

Page 43: ...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 ...

Page 44: ...efibrillation 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 en...

Page 45: ...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 ...

Page 46: ...llator 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 Defi Monitor Consider that the defibrillator switches back to asynchronous mode after ev...

Page 47: ...urnt 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 mis...

Page 48: ...before taking the paddles off the chest With the PRIMEDIC Defi Monitor an internal safety discharge is carried out when keeping 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 res...

Page 49: ...among others chapter 6 2 selection of the correct SpO2 sensor different sensors 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 Ev...

Page 50: ... 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 ...

Page 51: ...1 DM 1 DM 3 19499 05 03 109 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 ...

Page 52: ...Instructions for use PRIMEDIC Defi Monitor ECO 1 DM 1 DM 3 110 19499 05 03 3 Graph shape with 100 Ω U 3 180 V 2 ms div 4 Graph shape with 125 Ω U 2 800 V 2 ms div ...

Page 53: ...escription 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 SpO2 alarm 100 lower SpO2 alarm 80 signal amplification 2 cm mV accumulator capacity 80 100 ...

Page 54: ...DM 3 112 19499 05 03 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 SpO2 ...

Page 55: ...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 ALARM 2 Page Alarm 1 30 150 Alarm 2 40 160 Alarm 3 50 180 SpO2 Alarm 1 85 100 SpO2 Alarm 2 80 100 SpO2 Alarm 3 70 90 End Setup ALARM ...

Page 56: ... 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 SpO2 patient cable damaged ECG input socket SpO2...

Page 57: ...eartrate alarm goes on After acknowledgement of the alarm pressing of ALARM 28 heartrate alarm goes on once more for about 60 seconds 7 Functioning of the pulsoximeter Insert NELLXOR sensor DS 100 A and SpO2 patient cable into the socket 16 To control the function put index finger into the sensor or connect a SpO2 test advice to the SpO2 patient cable Is a SpO2 valuedisplayed Is the pulse curve di...

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