Schiller DEFIGARD Touch 7 User Manual Download Page 18

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Safety notes

1.12 Display Symbols/Indicators

Page 18

rt.

no.

: 0-48-

0227

Rev.:

DEFIGARD/PHYSIOGARD Touch 7

1.12.3

Symbols Used on the Batteries

Common symbols

Power battery (Li-Ion)

Safety primary cell (Li/MnO2)

P55

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

Used for electrical dangers during defibrillation (

DEFIGARD

Touch 7

)

The unit/component can be recycled.

Battery may not be disposed of with domestic refuse.

Do not burn, saw up or crash the battery

Do not short-circuit the battery

Expiration date

Rechargeable battery

Storage temperature for the power battery:
Unlimited: -10...+40 °C
Limited: -20...+65 °C for 48 hours

Non rechargeable battery

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

Read the instruction for use

Summary of Contents for DEFIGARD Touch 7

Page 1: ...1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 DEFIGARD TOUCH 7 1 4 0GARD TOUCH 7 User guide Art no 0 48 0227 Rev g 0 48 0227 ...

Page 2: ...correction according to Mantis Add IBP and Pacemaker 0 48 0227 f 3 11 2017 Update to Software revision 6 0 48 0227 g 8 02 2018 Adding correction according to Mantis The DEFIGARD Touch7 bears the CE 0459 mark Notified Body LNE G MED indicating its compli ance with the essential requirements of the Annex I of the Medical Device Directive 93 42 EE re garding safety functionality and labelling The req...

Page 3: ...2 1 Design 20 2 1 1 Standard unit and options 21 2 1 2 Additional accessories 21 2 2 Operating Elements 22 2 2 1 Front panel DEFIGARD Touch 7 22 2 2 2 Front panel PHYSIOGARD Touch 7 23 2 2 3 Back Panel 24 2 2 4 LEDs 24 2 2 5 Display 25 3 Initial Operation 26 3 1 External DC supply and Battery Operation 26 3 1 1 External DC Supply Operation 26 3 1 2 Battery Operation 27 3 1 3 Operation with externa...

Page 4: ... ECG messages 47 4 4 10 Print and pdf formats 48 4 5 Diagnostic ECG R ECG 49 4 6 SpO2 SpCO SpMet monitoring Option 50 4 6 1 Inaccurate or incorrect measurement result 51 4 6 2 Starting SpO2 monitoring and test 52 4 6 3 SpO2 Module 52 4 6 4 SpO2error and information messages 53 4 7 NIBP monitoring 55 4 7 1 Starting NIBP monitoring 57 4 7 2 NIBP Menu 58 4 7 3 NIBP Information and Error Messages 58 4...

Page 5: ...rillating children neonates 80 5 2 General function 81 5 2 1 Activating the manual defibrillation mode 82 5 2 2 Activating the automated AED defibrillation mode 83 5 2 3 Manual defibrillation procedure 84 5 3 Manual Defibrillation Using Pads 85 5 3 1 Applying the adult and paediatric electrodes 85 5 3 2 Applying the electrodes 86 5 3 3 Checking the electrodes 87 5 3 4 Manual Defibrillation Using P...

Page 6: ...tion file 108 8 1 3 Autotest 108 9 Main Menu 109 9 1 General setup 109 9 1 1 Device Settings Menu 110 10 Maintenance 112 10 1 Maintenance interval 112 10 1 1 Maintenance Interval Table 112 10 1 2 Service Shelf life 113 10 2 Functional test 114 10 2 1 Visual inspection of the device and accessories 114 10 2 2 Battery check 114 10 2 3 Defibrillator key test 114 10 2 4 Auto Test 115 10 2 5 Functional...

Page 7: ...ical data monitoring 139 12 4 1 ECG 139 12 4 2 Features of pacemaker pulse rejection 140 12 4 3 NIBP non invasive blood pressure 141 12 4 4 IBP invasive blood pressure 141 12 4 5 Temperature 141 12 4 6 SpO2 pulsoximetry 142 12 4 7 etCO2 Capnography 144 12 5 Telecommunication GSM option 146 12 6 Device Configuration 147 12 6 1 General configuration 147 12 6 2 ECG 148 12 6 3 Defibrillator 149 12 6 4...

Page 8: ...IOGARD Touch 7 12 7 2 Electromagnetic immunity 156 12 7 3 Recommended minimum distances 158 13 Appendix 159 13 1 Accessories and disposables 159 13 2 Accessories DEFIGARD PHYSIOGARD Touch 7 159 13 3 Literature 161 13 4 Glossary 161 14 Index 163 ...

Page 9: ... pads adult or child as those used for defibrillation The frequency and current of the pacemaker pulses are defined by the user There are two pacemaker modes as follows Fix The pacemaker pulse is delivered at a fixed frequency and current level de fined by the user On demand Current level and frequency are defined by the user The unit mon itors the ECG signal and generates pacemaker pulses if the ...

Page 10: ... for the continuous non invasive monitoring of breath rate and inspired expired gases during anaesthesia recovery and respiratory care The ISA gas analyser is intended to be connected to a patient breathing circuit for the continuous non invasive sidestream monitoring of breath rate and inspired expired gases during anaesthesia recovery and respiratory care The CO2 sensors are intended for use wit...

Page 11: ...d and understood the user guide and especially these safety notes Operating a device with a defective casing defective cables and sensors constitutes a danger to the patient or the user Therefore Immediately replace a damaged unit damaged cables sensors and connec tions Damaged or missing components must be replaced immediately The device including sensor and accessories must be serviced on a regu...

Page 12: ...ance with the specified technical data Do not expose the device to great temperature variations over a long period of time Major temperature variations can cause condensation water on the unit Should condensing water nevertheless occur dry the unit the defibrillation electrodes and all connections In case of strong water liquid spraying onto the device check the absence of water liquid in the batt...

Page 13: ...belled with the symbol can affect the operation of this device See section 10 9 3 Measures to prevent electromagnetic interferences page 126 Avoid using such devices or keep a sufficient distance from them The charging of energy and the release of the defibrillation impulse can disturb other devices Check these devices before their further use Sensors and devices that are not defibrillation proof ...

Page 14: ... or if exposed to the Internet or other insecure networks appropriate security measures must be taken to protect the stored patient data SCHILLER takes no responsibility for the configuration of Windows Patient data security and security of the network is the sole responsibility of the user In order to guarantee the security of the network Schiller recommends the following isolating the DEFIGARD T...

Page 15: ...mproper handling The warranty entitles free replacement of the defective part Any liability for subsequent damage is excluded The warranty is void if unauthorised or unqualified persons attempt to make repairs In case of a defect send the apparatus to your dealer or directly to the manufacturer The manufacturer can only be held responsible for the safety reliability and performance of the apparatu...

Page 16: ...rm functions Move up or down Move to the right or left For a direct danger which could lead to severe personal injury or to death For a possibly dangerous situation which could lead to heavy bodily injury or to death For a possibly dangerous situation which could lead to personal injury This symbol is also used to indicate possible damage to property For general safety notes as listed in this sect...

Page 17: ... date Read the instruction for use Devices with WLAN or GSM Attention Non ionic electromagnetic environment The device contains an HF transmitter The DEFIGARD PHYSIOGARD Touch 7 radiates high frequency electromagnetic energy during telemetric ECG data transfer and can disturb other devices if not installed and operated in accordance with the user guide However even in the case of correct installat...

Page 18: ...ed for electrical dangers during defibrillation DEFIGARD Touch 7 The unit component can be recycled Battery may not be disposed of with domestic refuse Do not burn saw up or crash the battery Do not short circuit the battery Expiration date Rechargeable battery Storage temperature for the power battery Unlimited 10 40 C Limited 20 65 C for 48 hours Non rechargeable battery Storage temperature for ...

Page 19: ...e Electrode Package This applies only to the DEFIGARD Touch 7 Open clothes Open the electrode package Peel off the protective foil Disposable item Single use only Do not bend packing Storage temperature for the electrodes Expiration date Read instruction before use Latex free Use within 1 day after opening Keep dry Keep out of direct sunlight ...

Page 20: ...posable adhesive electrodes pads which also measure the ECG signal for the analysis Adhesive electrodes for children and adults are available The device recognises the connected electrodes and selects the defibrillation energy levels accordingly In the AED mode the user will be given visual and audible instructions display loudspeaker Monitoring According to its configuration the DEFIGARD Touch 7 ...

Page 21: ...idestream 12 lead ECG GSM 3G WLAN CPR feedback FreeCPR CPR feedback ARGUS LifePoint PHYSIOGARD Touch 7 Standard 4 lead ECG cable SpO2 NIBP Temp sensor not included Options SpCO SpMet CO2 mainstream CO2 sidestream IBP 12 lead ECG GSM 3G WLAN 2 1 2 Additional accessories SCHILLER Charging Unit CS 1 External charging and calibrating unit for rechargeable batteries DC DC or AC DC ambulance charging br...

Page 22: ...t the device s front Shock key Power battery On off key Loudspeaker SpO2 NIBP ECG patient cable Defi pads USB USB CPR Feedback Battery DC Supply Status LED Status or Alarm LED Monitor ON Key AED ON key Temp Touch screen Safety primary cell not rechargeable SIM card for GSM option Screenshot Event Manual Def Start TEMP Check sensor HR NIBP OFF Menu R ECG Adult Optional Trunk cable for CO2 IBP ...

Page 23: ...ront panel PHYSIOGARD Touch 7 Power battery On off key Loudspeaker USB Battery DC Supply Status LED Status or Alarm LED Touch screen Screenshot Event Start TEMP Check sensor HR NIBP OFF Menu R ECG Adult NIBP Temp IBP SpO2 ECG patient cable Safety primary cell not rechargeable SIM card for GSM option Optional trunk cable for CO2 ...

Page 24: ...trol elements at the device s back 2 2 4 LEDs The LEDs give the following information Dovetail fixing joint Replaceable power battery DC input from Docking station Safety primary cell compartment for backup during battery change 1 Flashes while the battery is being recharged 2 Unit connected to the external power supply Fig 2 3 LEDs 1 2 ...

Page 25: ...te Menu Home Battery charging status Display field for system and alarm mes sages Touch to show alarm list ECG calibration impulse 1 mV Waveform field Soft keys Date time Event button Intervention duration Patient Information Start stop NIBP measurement Start Manual Defibrillation DEFIGARD Touch Resting ECG Alarm Status Black and white dis play Filter mode Monitoring Rhythm or Diagnostic screensho...

Page 26: ...y avoided Danger of electrical shock The DEFIGARD Touch 7 is a high voltage therapy device Improper use of the device can endanger life Always follow the instructions given in this user guide The user must make sure that there are no conductive connections between the patient and other persons during ECG analysis and defibrillation Avoid defibrillation in very moist or wet surroundings To avoid th...

Page 27: ...tinuously off battery is fully charged Fig 3 2 LED battery operation If the temperature in the device becomes too high the charging is stopped As soon as the temperature has decreased to an acceptable level the charging resumes Low battery indication When the battery is below 20 a red battery symbol with one bar is displayed in the top right corner of the screen When the battery is below 10 a red ...

Page 28: ...ally The battery can only be inserted in one way 1 Open the battery cover 2 To remove the battery press the two blue catches to release and remove the bat tery To replace proceed as follows Slide the battery into the battery compartment with the markings positioned as shown Push home until the battery clicks in place with the blue catches Close the battery cover and make sure that the cover is cli...

Page 29: ... desktop charging bracket is only for indoor use Do not use it in vehicles The device can easily be slid onto the desktop charging bracket Power supply connectors Power supply module AC DC or DC DC Click 1 2 Putting the device on the charging bracket Simply put the device back on the wall mounting The device is locked automatically You should clearly hear the click of the locking mechanism Removin...

Page 30: ... 48 0227 Rev g DEFIGARD PHYSIOGARD Touch 7 3 1 6 Operation and fixing during intervention During intervention the two positioning bars 1 can be folded out to keep the device in an ergonomic position During transportation the device can be fixed on a rail e g bed or stretcher rail 1 ...

Page 31: ...in 20 s after charging a lower energy value is selected while the defibrillator is charging the battery voltage is insufficient the device is defective the device is turned off Furthermore the residual energy stored in the defibrillator 100 ms after shock release is always discharged internally 3 2 3 Interruption of external power supply 1 Press the on off button 2 The dialogue No Yes is displayed...

Page 32: ...ent temperatures will have a negative impact on the battery s life To ensure its readiness for use the device runs a self test to check the unit and the battery A self test can be performed any time An enhanced periodic test can be performed in a defined interval standard setting every 5 weeks and at a defined time standard setting 12 00 Status OK green blinking LED Device failure status LED OFF I...

Page 33: ...icking on the menu soft key or any other soft key or by clicking on a icon or by moving finger up or down left or right for scrolling or changing display Fig 3 5 Display with main menu and the touch sensitive areas Screenshot Manual Def Start Menu HR Off NIBP Event R ECG Adult Start Menu HR Off NIBP Adult Stop Intervention 00547_160318_103611 Trends Screenshot Manual Def Event R ECG R ECG Screensh...

Page 34: ...r Printer As soon as the printer is found the printer s identification number is displayed e g RJ 40304072 5 As soon as the printer pairing is done printer status in the Data transmission menu indicates 6 Select Printer test page to check the printing function In case of communication problem with a Bluetooth device switch it off and on again Scan again for the Bluetooth device For detailed inform...

Page 35: ...an be as spot measurement regulary or for a defined period of time For details information refer to the ePCR manufacturer s user manual The DEFIGARD PHYSIOGARD Touch 7 acts like a slave to the ePCR equipment therefore the pairing must be initiated on the ePCR equipment The pairing is to be perfomed only the very first time that an ePCR equipement is connected 1 Select the transmission icon to disp...

Page 36: ...y displayed when the device is switched on if options are installed The device can basically be operated via the touch screen The functions of the soft keys vary according to the selected screen Settings The settings that are defined in the menus are set to default when the unit is switched off Operation and menu access is detailed on page 33 Screenshot Manual Def Start Menu HR Off NIBP Event R EC...

Page 37: ...ical care Menu Trends R ECG Choose another view Basic monitoring with 2 ECG leads and SpO2 curve big measurements filed with heart rate NIBP and SpO2 values Advanced monitoring with 2 ECG leads SpO2 EtCo2 curve measurements filed with heart rate NIBP SpO2 ETCO2 RR and Temp values Critical care with 2 ECG leads SpO2 EtCo2 IBP curve measurements filed with heart rate SpO2 Temp etCO2 RR IBP and NIBP ...

Page 38: ...sing or switching off of the audio alarm system is only allowed if the patient is permanently observed Alarm type Priority Audible signal Display Technical alarm Low One beep once Text display in the alarm status field at the top Displaying in the parameter field Orange LED is lit Physiological alarm Medium 3 signals beep beep beep Text display in the alarm status field at the top Orange flashing ...

Page 39: ...turn to the permissible range within the 2 min utes the audible alarm is reactivated automatically Switching off audio alarm system Press the button 1 and select Audio OFF The audible alarm system is switched off permanently until it is reactivated by selecting Reset Alarm Audio on or Audio Pause A reminder signal buub buub is issued every 2 minutes Reactivation of the paused or switched off audio...

Page 40: ...d Standard or user defined alarm limits as well as quick settings may vary for similar or the same devices Therefore always check the set alarm limits for the current patient 30 seconds after main battery power interruption the alarm threshold Wide Quick set or Narrow quick set is set to default With the Default key the default threshold values are activated With the Quick Set selection all values...

Page 41: ... 100 240 RR rpm Pat value Wide limits Narrow Limits Range 0 60 5 30 resp min Low High Low High 15 8 8 4 4 15 15 15 8 8 Allowed values 5 15 10 60 5 15 10 60 SpO2 Pat value Wide limits Narrow Limits Range 50 100 85 100 Low High Low High 90 5 3 5 3 90 5 3 5 3 Allowed values 85 100 90 100 85 100 90 100 SpCO SpMet Pat value Wide limits Narrow Limits Range Low High Low High SpCO 0 40 0 10 0 10 0 10 SpMe...

Page 42: ...25 65 90 15 15 15 10 90 15 15 15 10 Allowed values 12 210 12 210 12 210 12 210 NIBP MAP mmHg Pat value Wide limits Narrow Limits Range MAP 15 223 20 235 mmHg IBP SYS mmHg Pat value Wide limits Narrow Limits Range SYS 30 255 50 200 mmHg Low High Low High 90 20 35 10 25 90 114 20 35 10 25 115 140 25 35 10 20 140 25 35 10 20 Allowed values 30 245 30 245 30 245 30 245 IBP DIA mmHg Pat value Wide limit...

Page 43: ...aves Isoelectric parts I wave are also excluded in the duration measurement of the respective adjacent waveform For more detailed information see 2 530036c Statement_of_accurracy 3ed_ETM For a quick diagnosis the ECG signal can be recorded from the patient s thorax using the defibrillation electrodes In all other situations we recommend acquiring the ECG via ECG electrodes and the patient cable To...

Page 44: ...al source by touching the first curve standard ECG II on the display and selecting ECG Defi The first display curve is used to calculate the heart rate unless the HR source is set to Pleth Fig 4 4 4 wire cable Note The electrode positions shown here O are based on the diagnostic ECG For patient monitoring the limb electrodes can be attached on the upper body Fig 4 5 10 wire cable Yellow Red Black ...

Page 45: ... 4 Open the HR module ECG menu and check the settings Fig 4 6 ECG cable The screen The sweep speed on the screen is fixed to 25 mm s Curve List ECG Defi ECG I ECG II ECG III ECG aVr ECG HR source Auto Scale Amplitude ECG filters QRS sound level QRS complexes are represented by green vertical dashes above the top ECG curve pacemaker pulses by red vertical dashes Curve List ECG II ECG Defi Back to D...

Page 46: ...cer pulse parameters For pacemaker patients the ECG signal amplitude should be greater that 1 mV Erroneous HR display In the monitoring of pacemaker patients the possibility of pacer pulses being counted as QRS complexes cannot be excluded Therefore pacemaker patients should always be watched closely It is recommend monitoring pacemaker patients by means of the plethysmogram HR source Pleth in the...

Page 47: ...ill automatically select the source with the following priorities DEFI ECG Pleth Auto Scale Automatic scale of the ECG amplitude OFF ON ECG Curve amplitude ECG amplitude setting 0 25 0 5 1 2 cm mV ECG Filter Filter settings EMG ON OFF electromyogram BLW ON OFF baseline wandering Detailed information see ECG amplifier band pass page 140 QRS sound Volume of the systolic sound Off Low Medium High Ala...

Page 48: ...ts according to its configurations PDF resting ECG format 12 averages 6 leads 12 5 mm s 1 page 1x12 leads 50 mm s 2 pages 4x3 leads 1 rhythm lead 25 mm s 1 page 2x6 leads 25 mm s 1 page 1x12 leads 25 mm s 1 page Print resting ECG format 12 averages 4 3 leads 25 mm s 7 pages 4x3 leads 1 rhythm lead 25 mm s 2 pages 4x3 leads 1 rhythm lead 50 mm s 3 pages 2x6 leads 25 mm s 2 pages ...

Page 49: ... possible to scroll the R ECG in the x y axis for reviewing 8 Transmit the ECG with following options Press Send to transmit the file via the defined transmission path e g GSM 3G Wi Fi Bluetooth to SEMA e mail USB storage Press Print to print the ECG to an external Bluetooth printer Press Interpr to open the interpretation information Press Measur to open the measurement information If transmissio...

Page 50: ...and pulse rate The display shows the continuous progress of the numeric SpO2 value pulse rate plethysmographic waveform and signal quality The displayed plethysmographic curve is not proportional to the pulse volume The update period of the measurement readings on the display is 0 2 seconds According to the relevant standards the temporary alarm suppression must not exceed 2 minutes Equipment used...

Page 51: ... components Change the position of the sensor at least every 4 hours and every 2 hours if the perfusion is low When patients are undergoing photodynamic therapy they may be sensitive to light sources Pulse oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy Inaccurate measurements can be caused in general by Imprope...

Page 52: ...finger Fig 4 8 SpO2 measurement field MENU Parameter Description Value SpO2 HR Source a Source based on which the heart rate should be determined a When the patient has a cardiac pacemaker the HR source must be set to Pleth see page 46 Auto Defi ECG or Pleth If set to Auto the device will automatically switch sources with following priority DEFI ECG Pleth Average Definition of the integration time...

Page 53: ...counts for Invalid HR pleth Invalid SpCO Invalid SpMet I SP204 I SP212 I SP207 I SP210 Value is not plausible SpCO readings may not be provided if there are low arterial saturation levels or elevated methaemoglobin levels Check the patient Check the sensor and reapply Pulse Search T SP230 Device is searching for the pulse Make sure that the sensor is well connected to the patient Sensor Off patien...

Page 54: ...223 T SP224 T SP225 T SP227 No sensor connected Sensor life expired Incompatible sensor Unrecognised sensor Cable and sensor fault No adhesive sensor connected Adhesive sensor life expired Incompatible adhesive sensor Unrecognised adhesive sensor Defective adhesive sensor Defective sensor Check replace the sensor Check cable and sensor fault Alarm measurement field Code Cause Remedy ...

Page 55: ...automatic operation the connected body areas of the patient and the extremity to which the cuff is attached must be checked regularly for signs of ischaemia purpura and or neuropathy especially in patients with decreased pain sensitivity due to medication or with older patients with decreased blood circulation of the extremities The cuff must not be attached to a limb that is already used for inte...

Page 56: ...ults ensure that the tube is not pinched or compressed A cuff that is applied to a patient in the recumbent or sitting position is normally located at the same level as the heart However if the cuff is located at a level higher than the heart for instance if the arm of a patient in bed is lifted this may result in lower than actual measurement readings approx 7 5 mmHg per 10 cm rise The measuremen...

Page 57: ...en the NIBP menu and check the settings Setting of the Automatic cycle time or manual measurement 6 Start the NIBP measurement by pressing the soft key Start To disconnect the cuff tube press the milled shell of the connecting sleeve backwards Clean and disinfect the cuff after each use see chapter 10 5 Cleaning page 119 and 10 6 Disinfection page 120 The following settings are available for the c...

Page 58: ...and connection for leaks Unable to measure T NIBP12 No signal pulse detected at 50 mmHg Check patient cuff and hose Cuff not present T NIBP13 Pressure in the cuff remains too low 10 mmHg during 10 s Check cuff and connection for leaks Wrong cuff T NIBP14 Pressure too high because Too small cuff applied Tube buckled Check cuff and connection Artefacts detected T NIBP15 T NIBP16 Measurement disturbe...

Page 59: ...ing objects even if these are earthed Special care must be exercised when the unit is used with high frequency equipment To prevent incorrect IBP measurements only use sensors that are protected against high frequency radiation The kit and operating procedure vary according to manufacturer Please consult the manufacturer s documentation for connection For warm up time ready for measurement and dis...

Page 60: ... 3 Zeroing the IBP see Zeroing 4 Check the IBP curve on the display to see if the connections have been made correctly and the IBP value is in the expected range Start measurement ON 1 Curve amplitude mmHg Zeroing 2 IBP curve IBP measurement field with Systolic Diastolic and mean arterial pressure Screenshot Manual Def Start Menu Event R ECG HR Menu item Parameter Description IBP parameter Start m...

Page 61: ...carry out the zeroing Alarm Code Cause Remedy No sensor T_IBP01 Cable not connected to the device Check cable connection to the device Catheter disconnected T_IBP02 Catheter disconnected Catheter valve closed Check catheter Check catheter valve Zero required T_IBP03 No zeroing has been done Zero point sensor too high low by more than 30 mmHg or unsteady pressure Check tube system sensor and valves...

Page 62: ... a reliable measured value independent of the measuring site the measurement duration must be at least 2 minutes The temperature measurement method is Direct mode 1 Connect the sensor to the temperature input 2 Select the TEMP measurement field to open the Temp menu 3 Select OFF ON button to start the measurement Menu item Parameter Description Start measurement On or OFF Calibrate Calibration of ...

Page 63: ...tric Adult airway adapter for infants because the adult adapter adds 6 ml dead space to the patient circuit Do not use the IRMA Infant airway adapter for adults because this may cause excessive flow impedance Do not use the airway adapter with metered dose inhalers or nebulized medica tions as this may affect the light transmission of the airway adapter windows The IRMA sensor is not intended to b...

Page 64: ...vent the windows soiling by secretions of the patient or condensing water position the adapter in a slightly angled position between the endotracheal and the respiration tubes Alternatively connect a HME Heat Moisture Exchanger between the patient s endotracheal tube and the IRMA probe Placing a HME in front of the IRMA probe protects the airway adapter from secretions and effects of water vapor a...

Page 65: ...ventilated only with air set it to Air 1 Connect the sensor cable to the main cable 1 Snap the sensor head on top of the airway adapter Make sure it clicks into place 2 A green LED indicates that the sensor is ready for use 3 Select the EtCO2 measurement field 2 to open the EtCO2 menu 4 Select OFF ON button 3 to start the measurement 5 Check if the etCO2 value is zero 6 If needed carry out a zeroi...

Page 66: ... that no exhaled air enters the airway adapter The green LED on the probe will be blinking for approximately 5 seconds while zeroing is in progress 5 If the message CO2 calibration is required is again displayed perform the zeroing again 6 If the message CO2 calibration is required is no longer displayed the zero ing has been performed 7 Reconnect the airway adapter with the sensor to the breathin...

Page 67: ...ashing red Check the adapter Flashing green Zeroing in process Menu item Parameter Description Start measurement On or OFF Curve amplitude 8 12 or 15 Perform zeroing Zeroing the sensor to ambient air Type of ventilation Air patient ventilated only with air Air O2 patient ventilated with Air and O2 MENU Parameter Description Value Curve list Touch first curve Selection of the displayed first curve ...

Page 68: ...eroing in progress T ETCO202 Zeroing process started Wait till zeroing process ends Replace adapter T ETCO204 Adapter polluted with patient secretions Replace CO2 adapter if polluted No adapter T ETCO205 No or incorrect CO2 adapter Adapter not properly connected Check if IRMA CO2 adapter is properly connected Internal temp out of range T ETCO214 Temperature sensor too high low Check standard opera...

Page 69: ...he centre of the adapter see picture on the left Do not use the sampling lines with metered dose inhalers or nebulized medications as this may clog the bacteria filter The ISA sensor is not intended to be used as the only means of monitoring a patient Excessive positive or negative pressure in the patient circuit e g excessive scavenging suction pressure might lead to incorrect readings Exhaled ga...

Page 70: ...4 Monitoring 4 11 CO2 Sidestream Page 70 Art no 0 48 0227 Rev g DEFIGARD PHYSIOGARD Touch 7 The Nomoline sampling line is designed for single use only do not reuse ...

Page 71: ...lect the EtCO2 measurement field 3 to open the EtCO2 menu 5 Select OFF ON button to start the measurement 6 Breathe briefly into the sampling line and check that the CO2 curves and values are displayed correctly 7 Occlude the sampling line with your fingertip and wait for 10 seconds 8 Check that an occlusion alarm is displayed and that the gas analyser shows a flashing red light Replace the sampli...

Page 72: ... Zeroing process started Wait till zeroing process ends Sampling line clogged T ETCO207 Indicates sampling line occlusion Replace sampling line No sampling line T ETCO208 Indicates that a sampling line needs to be fitted Check if IRMA CO2 adapter is properly connected Internal O2 port failure T ETCO209 Sensor failure If persistent replace sensor Internal temp out of range T ETCO214 Temperature Sen...

Page 73: ... sensor to ambient air Type of ventilation Air patient ventilated only with air Air O2 patient ventilated with Air and O2 MENU Parameter Description Value Curve list Touch first curve Selection of the displayed first curve The first displayed curve is used to calculate the Heart rate unless the HR source is set to Pleth II or Defi Default Touch the curves 2 3 4 Selection of the displayed curve Def...

Page 74: ...s are displayed Select one of these texts this text will be recorded in the data report together with the time Select Cancel last to indicate that an incorrect event was selected A Cancel Last event and time stamp are stored in the event list Fig 4 10 Event button Data ECG automatic and manual events can be displayed on a PC by use of the Schiller data reviewing Software Events ...

Page 75: ...creen 3 Close the Trends screen with the button or Close button Fig 4 11 Trends screen 1 Enter the main menu and select R ECG 2 Select one of the R ECG records on the R ECG list 3 The following screen appears 4 Exit the viewing mode by pressing the Close button 5 To print the resting ECG click on Print Menu Stop Intervention 00547_160318_103611 Trends R ECG Screenshots Menu Choose an other view Tr...

Page 76: ...reenshot on the list 3 The screenshot appears with a watermark 4 Exit the viewing mode by pressing the Red X button on the top left corner To print a screenshot tick the box on the right and click on next Several screenshots can be selected and printed The screenshot is available for printout only when the icon has switched from camera to camera printer The printout files may take some time to be ...

Page 77: ... have been made Transmitting R ECG or Sreenshots Network search for Menu 1 Enter the main menu and select R ECG or Sreenshots 2 Select one of the R ECG records as example 3 Press the button next and select the desired transmission channel GSM 3G Wifi USB Ethernet or USB storage 4 The transmission icon on the top right status bar shows the progress of the trans mission 5 Select the transmission ico...

Page 78: ... metal parts which are in contact with the patient The patient s chest must be dry as moisture causes unwanted pathways for the defibrillation current For safety wipe off flammable skin cleansing agents Owing to the high currents there is a risk of skin burns at the site of the electrodes This is why the electrodes must not be placed on or above the sternum clavicle or mamillas Immediately prior t...

Page 79: ...g for lack of consciousness lack of breathing and lack of circulatory signs using the ABCD system BLS algorithm The device must only be used if the following symptoms are found non responsive no respiration no pulse If in the course of treatment a patient spontaneously regains consciousness a defibrillation shock that may have been advised just before must not be delivered To ensure correct analys...

Page 80: ...see illustration 1 2 below Defibrillation on neonates When using the defibrillator on neonates follow the local guidelines Follow the energy setting for infants and small children as described above The automatic energy setting for neonates is the same as for children When paediatric pads are used the patient type setting Adult or Child Neonate on the screen does not overrule the energy setting wh...

Page 81: ...displayed via the separate ECG electrodes or the defibrillation electrodes You can select a higher energy value while the defibrillator is charging The device will charge to the new level It is not possible however to reduce the charged energy In this case the stored energy will be discharged internally and you will have to recharge the defibrillator The required energy for a successful defibrilla...

Page 82: ...tly start in manual defibrillation mode When the device starts in Monitoring or AED mode Switch to manual mode by pressing the soft key Manual Def and confirm with Yes Manual def Number of released shocks Low Elapsed time since the last shock Electrode impedance Indication of pads type Child or Adult Switching operational modes asynchronous or synchronous Selection of energy via or button Charging...

Page 83: ...by pressing the AED key In the AED operational mode the alarm system remains active in the same state as in the monitoring operational mode Manual def Number of released shocks Indication of pads type Text instruction Action picture 30 CHEST COMPRESSIONS THEN 2 RESCUE BREATH ECG curve displayed when soft key ECG curve is pressed Analyse soft key CPR Analyse Elapsed time since the last shock Electr...

Page 84: ...lation see 5 2 1 page 82 Confirm switching to manual defibrillation This depends on the device s configuration see 12 6 1 General configuration 2 Select the required energy via the touch screen button or 3 Charge the energy using the Charge button 4 Release the shock with shock button on the device Fig 5 1 Defibrillator window Manual def CPR Event Screenshot ...

Page 85: ...5 kg The energy setting is automatically reduced default 50 Joule with the paediatric electrodes The default can be set in the device s configuration see 12 6 3 Defibrillator Delivering a shock to a patient with normal heart rhythm may induce ventricular fibrillation For this reason first read the general rules and safety information in sections 5 1 and 5 2 Electric shock hazard Turn off the devic...

Page 86: ... trode application sites page 86 Fig 5 3 Electrode application sites for children weighing 25 kg or more page 86 Only clean the skin by vigorously rubbing it with a dry cloth 2 Apply one electrode above the right nipple Do not apply it on the clavicle une ven 3 Apply the other electrode slantwise below the left breast as illustrated in Fig 5 2 Adult electrode application sites page 86 Fig 5 3 Elec...

Page 87: ...RODES AED mode or Manual mode is issued Proceed as follows 1 Alternately press the electrodes pads down firmly and check when the message disappears Carefully press that pad onto the patient s skin once again If the message does not disappear 2 remove both defibrillation electrodes 3 wipe rests of contact agent off with a cloth 4 shave both application areas to remove the uppermost layer of skin 5...

Page 88: ... descrip tion in chapter 5 2 1 Activating the manual defibrillation mode page 82 3 Select the energy via the touch screen 4 Initiate the energy charging by pressing Charge Danger of electric shock Do not under any circumstances touch the patient during shock delivery Make sure that the patient does not touch any conducting objects 5 Trigger the shock by pressing the button 6 Finish the therapy see...

Page 89: ...ed Do not touch the device during defibrillation to prevent electrostatic noise Keep the patient cable away from power cords transformers etc To achieve adequate ECG signal quality for reliable triggering ensure that the ECG signal is free of artefact there are no major fluctuations in amplitude the displayed trigger pulses are positioned exactly above the R wave The synchronized mode 1 is manuall...

Page 90: ...upplied to the defibrillator After the physician has triggered the defibrillation shock the trigger signal for the actual shock delivery will be derived from the subsequent QRS complex 25 ms after the trigger mark on the monitor screen 1 In case of absence of QRS an internal discharge will occur in a delay of 20 30 seconds Be aware that after initiation of the shock the actual shock will be releas...

Page 91: ... If a second attempt is contemplated return to step 4 3 Select synchronised defibrillation via the touch screen 1 4 The setting ON 2 is displayed below the Sync label 5 Check ECG rhythm the QRS beep sounds the trigger pulses above the R wave 6 Select the desired energy with the button 7 Charge the desired energy with the button Charge As soon the defibrillator is ready for shock an audio signal so...

Page 92: ...nterior anterior positions With infants anterior posterior placement can be advised to prevent a short circuit between the two defibrillation electrodes If in the course of treatment a patient spontaneously regains consciousness a defibrillation shock that may have been advised just before must not be delivered During HF surgical interventions ECG analysis is not permitted in the semi automated mo...

Page 93: ...d and the resistance is between 25 to 250 Ohm Do not touch the patient Analysing DO NOT TOUCH THE PATIENT ANALYSIS Movement detected Analysis cancelled resume CPR Movement detected Analysis cancelled resume CPR Technical alarm Patient was moved during analysis and device could not run analysis Device recommends a shock Shock advised Stand clear of patient press orange button Stand clear of patient...

Page 94: ...pply the defibrillation electrodes see section 5 3 1 Applying the adult and pae diatric electrodes page 85 page 85 The message CONNECT THE ELECTRODES is switched off as soon as the de vice measures an acceptable electrode resistance If it is not switched off see section 5 3 1 Applying the adult and paediatric electrodes page 85 Fig 5 8 Switch unit on 6 The analysis starts automatically when the el...

Page 95: ... shock delivery step 4 follows Step 4 Cardiopulmonary resuscitation 10 Carry out cardiopulmonary resuscitation Alternate between 30 chest compres sions and 2 breaths1 for 2 minutes2 After 2 minutes the device begins again with Step 2 Analysis 11 Finish the therapy see page 106 The following default energy values are programmed Shock Adults Children 1 150 joules 50 joules 2 200 joules 50 joules 3 2...

Page 96: ... sensor Advice to improve the CPR quality CPR Screenshot Analyse PRESS FASTER MESSAGE COMPRESSION FREQ DEPTH RECOIL good 30 CHEST COMPRESSIONS THEN 2 RESCUE BREATH Close Manual def Event 78 4 9 1 Connect the LifePoint USB cable to the adapter cable 2 Switch on the device and select manual or AED defibrillation 3 Open the CPR menu and activate the CPR guide 4 Place the LifePoint on the patient ches...

Page 97: ...ings 1 Switch on the device and select manual or AED defibrillation 2 Apply the defibrillation electrodes 3 Open the CPR menu and activate the CPR guide 4 The displayed measurements on the right side of the screen inform you about the CPR quality and frequency 1 Open the CPR menu 2 Activate the metronome 3 The following settings are available 30 2 15 2 Continuous CPR CPR METRONOME CPR GUIDE OFF ON...

Page 98: ...DEFI12 Internal discharge while releasing shock on impedance higher than 250 ohm or if the current during the shock is 0 or above 105 A because of poorly placed electrodes Check electrodes if necessary re apply electrodes Internal discharge duration too long T DEFI09 A shock that is not delivered within the specified duration causes an in ternal discharge Do not exceed the time of 20 sec onds till...

Page 99: ...ly identify QRS complexes it will stimulate the heart permanently in demand mode The demand mode is the recommended pacing mode when the patient is at risk of developing bradycardia or even asystole as a result of a critical event As the pacemaker function is controlled by the patient s ECG the harmful competition between intrinsic and external stimulation which could induce ventricular fibrillati...

Page 100: ...current output is required to be floating this is an additional safety precaution to ensure that the pacemaker current pulse flows only between the pacemaker electrodes Set all values for the pacemaker to position 0 or the lowest value Position stationary pacemakers close to the patient After each defibrillation check that the pacemaker is functioning properly Shock hazard Never touch the pads or ...

Page 101: ... same adhesive electrodes used for defibrillation are also employed for pacing The electrodes are designed for 1 hour of pacing using 140mA 120p min pulse duration 20ms 8 hours of pacing using 70mA 60p min pulse duration 20ms with inspection of pads every 30 minutes 10 minutes of pacing using maximum energy and frequency output 150mA 210p min A detailed application of electrodes is given in sectio...

Page 102: ...the current value is set to 10 mA The device can be switched from pacing to defibrillation mode at any time The pacemaker is stopped by confirming the switchover The device can be switched from pacing to monitoring mode at any time In this case the pacemaker screen is displayed as small measurement field at the top right If the pacemaker function is OFF and closed by pressing the Close key the fre...

Page 103: ...r switch to monitoring with the monitoring key In this case the pacemaker values are displayed as small measurement field 1 at the top right and the curve field shows again all curves Select the Pacer measurement field at the top right to display the pacemaker function The pacemaker menu with the pacemaker parameter is displayed The pacemaker default mode at switchover is Demand mode the Fix mode ...

Page 104: ...e Pacer OFF ON 2 to activate the pacemaker 5 Press the 3 Current mA to set the impulse current until the heart reacts to the stimulation 6 The pacemaker can be interrupted and restarted by selecting the Pacer OFF ON 7 Finish the therapy as described in section 7 Finishing the Therapy page 106 Shock hazard Pacing is started immediately when the pacemaker is switched ON and the current is set Never ...

Page 105: ...pacemaker can be interrupted and restarted by selecting the Pacer OFF ON 7 Finish the therapy as described in section 7 Finishing the Therapy page 106 6 4 5 Switching from pacemaker to defibrillation To determine when a pacemaker pulse is required the patient ECG must be monitored with a 4 or 10 lead ECG cable Shock hazard Pacing is started immediately when the pacemaker is switched ON and the cur...

Page 106: ... therapy is finished by pressing the button The dialogue No Yes is displayed 2 Confirm switch off 3 Disconnect the electrode cable Adhesive electrodes Carefully remove the electrodes from the patient s skin Discard the disposable pads immediately after use to prevent their reuse hos pital waste Clean the device ECG cables and sensors as described in section 10 6 2 page 119 ü ...

Page 107: ...ion has been stopped with the function Stop Intervention in the main menu Stop Intervention is also used to start a new intervention The data will be stored until the data has been transmitted via the menu Post Intervention All intervention data R ECG Screenshots and Trends can be reviewed and transmitted on the device via the menu Post Intervention see next page Menu Stop Intervention 00547_16031...

Page 108: ... directly on the device go to the main menu and select Post intervention 2 Stop the patient monitoring The Post Intervention menu is displayed 3 Select Memory to display the intervention list 4 Select desired intervention 5 For each intervention you can review print or send the following data For each intervention it is also possible to printout a full intervention report composed of patient data ...

Page 109: ...eset in the DEFIGARD PHYSIOGARD Touch 7 which are activated when the device is turned on The operator defined thresholds wide narrow can be set in the respective menus see page 40 section 4 3 1 Press the Menu soft key The menu is displayed Fig 9 1 Main menu Start Menu HR Off NIBP Adult Menu Stop Intervention 00547_160318_103611 Trends Screenshot Manual Def Event R ECG R ECG Screenshots Choose anot...

Page 110: ...itted in the Post intervention menu The number under the Stop Intervention parameter shows the Intervention ID with date and time Post Intervention Exiting Post Intervention menu only by switching off the device possible Transmission Clear memory Transmission Clears memory of all intervention files Memory Memory of all intervention files since the last clearing The file can be reviewed via this me...

Page 111: ...Control panel menu only by switching off the device possible Ethernet config DHCP ON OFF Radius ON OFF If set to OFF IP address Netmask Gateway DNS1 3 Server If DHCP is set to ON Check connectivities Check SEMA connectivities Check SUS connectivities Select one of the desired communication channels GSM 3G or Wi Fi for checking Activates the connectivity check for SEMA Activates the connectivity ch...

Page 112: ...ke sure that both batteries are sufficiently charged see section 10 2 2 After every intervention Visual inspection of the device and accessories see section 10 2 1 Battery check see section 10 2 2 Button test see sections 10 2 3 Auto Test in the Post intervention menu see section 10 2 4 User Monthly Functional test charging capacitor see section 10 2 4 User Every 12 months Measuring and safety che...

Page 113: ...10 1 2 Service Shelf life Device The device has a lifetime of 10 years Accessories shelf life Power battery approx 5 years safety cell approx 7 years button cell approx 10 years and electrodes approx 2 years see expiring date on the battery or electrodes pouch EtCO2 accessories see expiring date on the packaging ...

Page 114: ...tch it on The start screen is displayed The external DC voltage indicator is lit When the battery indicator is flashing the battery is being charged Check the charging status once the indicator goes off The battery indicator is off when the battery is fully charged the full bat tery symbol is displayed The charging process can be reactivated and checked by disconnecting shortly from the external D...

Page 115: ... the Touch 7 according to section 4 8 1 page 59 2 Perform a zeroing according to section 4 8 4 page 61 3 Zeroing is shown on the display CO2 Mainstream Perform the functional test according to section 4 10 3 page 65 CO2 Sidestream Perform the functional test according to section 4 11 2 page 71 10 2 6 Alarm tests Alarm volume Check during the following tests that the alarm sound is higher than 65 d...

Page 116: ...Page 116 Art no 0 48 0227 Rev g DEFIGARD PHYSIOGARD Touch 7 4 Reset the alarm limits to their original values If the device does not behave as described in this user guide there is an error that must be repaired by the after sales service ...

Page 117: ... switches off 5 Switch the device on again and enter the Menu Control Panel Software up date Current software version to verify that the software has been installed 10 3 2 Update via Server Required accessories Wifi or GSM 3G connection to the update server Update 1 Switch on the device and make sure that it is connected to the DC supply or that the battery is charged sufficiently The device must ...

Page 118: ...h ambient conditions the battery is used Power Battery The rechargeable power battery is maintenance free during its normal life The battery must be replaced according the expired date on the battery regardless of whether or not the unit has been used Only store fully charged batteries If a battery is not used recharge it every 6 months Safety primary cell The safety primary cell is maintenance fr...

Page 119: ...ents 70 isopropyl alcohol Neutral detergents Soap water All products that are suitable for ABS plastic Non admissible detergents Never use products containing the following Ethyl alcohol Acetone Hexane Abrasive cleaning powder Plastic dissolving products Cleaning removes dust dirt and stains however this does not constitute a disinfection Use commercially available detergents intended for clinics ...

Page 120: ...rganic solvents Ammonia based detergent Abrasive cleaning agents 100 alcohol Virex Sani Master Sani Cloth Ascepti or Clorox wipes HB Quat Conventional cleaner e g Fantastic Tilex etc Conductive solution Solutions or products containing the following ingredients Acetone Ammonium chloride Betadine Chlorine wax or wax compound Ketone Sodium salt Use commercially available disinfectants intended for c...

Page 121: ...quids and dust from entering the ISA gas analyzer through its sampling gas inlet connector keep the Nomoline Family sampling line fitted while cleaning the analyzer 10 7 Disposal at the end of the device s useful life Remove the battery and close the cover before cleaning See section 3 2 Switching off and disconnecting from the external DC supply page 31 Do not immerse the unit nor the cable or se...

Page 122: ...n the check list Visual inspection of the device and accessories see section 10 2 1 Battery charging status see section 10 2 2 Button test see sections 10 2 3 Auto Test in the Post intervention menu see section 10 2 4 10 8 1 Monthly Functional test charging capacitor with maximum energy This is done with the Auto test function see section 10 2 4 Year Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17...

Page 123: ...tion Inspector Inspection Results Replacement Battery Replace battery The battery needs to be replaced when the operating time is less than 1 hour see section 10 4 1 Replace the safety primary cell see expiring date or when de vice switches of immediately when replacing power battery Replace the internal button pri mary cell every 10 years o o o o o o o o o o o o o o o Date of replacement Inspecto...

Page 124: ... power supply docking Station and charge battery Replace device Device cannot be switched off Software hangs The device is defective Keep the green button pressed for at least 10 seconds Replace device No analysis ECG signal too weak ECG signal interference through electromagnetic waves Patient moved or touched dur ing analysis The device is defective Perform cardiac massage again Turn off source ...

Page 125: ... T CPU06 T CPU07 Replace device BACKUP BATTERY EMPTY T CPU08 T CPU09 Replace device SAFE BATTERY EMPTY T CPU10 T CPU11 Replace device LOW POWER BATTERY T CPU12 Replace device POWER BATTERY EMPTY T CPU13 Replace device POWER BATTERY CHARGE FAILURE T CPU14 Replace device ECG INOPERATIVE T ECG01 T ECG02 T ECG03 T ECG04 T ECG05 T ECG06 T ECG07 T ECG08 T ECG09 T ECG10 Replace device DEFI INOPERATIVE DE...

Page 126: ... distance depends on the output performance of the communication device as indicated below HF source Transmitter fre quency MHz Power P W Distance d m Radio telephone microcellular CT1 CT2 CT3 885 887 0 010 0 23 Cordless DECT telephone WLAN UMTS phone 1880 2500 0 25 1 17 Mobile phone USA 850 1900 0 6 1 8 Mobile phone GSM900 GSM850 NMT900 DCS 1800 900 850 900 1800 2 1 3 3 2 3 Walkie talkie rescue s...

Page 127: ...r supply 11 2 Inserting a battery Insert the battery in the charger unit and push home until the battery clicks in place with the blue catches To remove a battery press the two blue catches to release it 1 Control indicator panel 2 Battery slot 1 only this slot can be used for battery calibration 3 Battery slot 2 The batteries supplied are rechargeable Lithium Ion 4 65 Ah batteries Only use rechar...

Page 128: ... battery inserted Constant display for 5 seconds When a battery is first inserted one two or three LEDs are lit for 5 seconds This indicates the battery charge state 1 LED 1 3 capacity 2 LEDs 2 3 capacity and 3 LEDs 100 capacity LEDs are flashing in sequence left to right After 5 seconds of a battery being inserted the charge sequence starts All LEDs lit battery fully charged LEDs are flashing in ...

Page 129: ...ibration cycle takes approximately 2 5 5 hours to complete the full charge cycle after full discharge takes approximately 2 5 hours During the calibration process The LED above the calibration key is lit To indicate the discharge cycle the three indicators LEDs blink in sequence right to left When the discharge cycle is finished the three indicators LEDs blink in se quence left to right to indicat...

Page 130: ... following input and output power supplies 2 3 4 5 6 1 7 1 On Off switch 2 Potential equalisation to vehicle common earth Yellow Green Cable 3 Power output do not use 15 V 4 Spare power output to docking station 8 48 VDC do not use 19 V 5 Spare power output to docking station 8 48 VDC do not use 19 V fix or 12 V to 48 V 6 DC IN from vehicle power supply 12 V to 48 V DC 7 Fuse 5 x 20 mm 20 A ...

Page 131: ...d ambulance bracket Input Output Type XP Power Model AHM85PS15 Medical grade switching power supply protection class I 100 240 VAC max 1 0 A 50 60 Hz 15 VDC max 5 67 A Power battery Battery type Autonomy Charging time Safety primary cell Battery type Lithium ion 11 1 V 4 65 Ah 51 6 Wh 100 shocks with maximum energy or 6 hour monitoring 90 2 hours after full discharge and device switched off Ensure...

Page 132: ...ondensing 35 C to 70 C at a water vapour pressure up to 50 hPa after having been removed from its protective packaging and subsequently between uses 30 minutes Time required for the DEFIGARD PHYSIOGARD Touch7 to warm or cool from the minimum maximum storage temperature between uses until the DEFIGARD PHYSIOGARD Touch7 is ready for its intended use when the ambient temperature is 20 C Device was te...

Page 133: ...rd IEC EN 60601 2 4 The device is designed for intensive use EMC IEC EN 60601 1 2 IEC EN 60601 2 4 CISPR 11 class B The device can be exposed to the following interferences without any impairment Static discharges up to 15 kV Field strength up to 20 V m in the radio frequency range of 80 2500 MHz 5 Hz modulated Magnetic fields of 100 A m 50 Hz Conformity CE according to directive 93 42 EEC class I...

Page 134: ... 8 2 25 2 7 3 15 3 6 4 5 5 4 6 3 9 45 9 86 Second phase Max current A 36 6 28 5 23 5 20 17 1 14 3 11 8 9 9 6 6 6 5 Mean current A 18 6 16 4 14 7 12 6 11 5 9 4 8 2 7 1 4 9 4 9 Duration ms 2 25 2 700 2 700 3 150 3 150 3 600 3 600 4 050 4 050 4 050 Total shock duration ms incl 0 5 ms of pause between first and second phase 4 55 5 45 5 9 6 8 7 25 8 6 9 5 10 85 13 55 14 4 Energy delivered J 196 192 189...

Page 135: ...ttery with 15 VDC mains voltage after 15 discharges with max energy from switch on of the device with pads Time used to charge the storage capacitor to the max energy of 200 J in manual mode 8 seconds 9 seconds 19 seconds Cycle Time Rhythm Analysis Shock Standby in AED Mode with fully charged battery with 15 VDC mains voltage after 15 discharges with max energy from switch on of the device to char...

Page 136: ...dhesive defibrillation electrodes Defibrillation electrode connection Type BF defibrillation protected 5 kV Defibrillation electrodes Adult and Paediatric electrode Electrode cable 2 m long Deviating from the compliance statement according to 201 108 1 10 IEC60601 2 4 201 1 108 7 and 201 1 108 6 the following features have been measured for the universal electrode 80 cm2 active surface Measurement...

Page 137: ...on Science Poster Session Abstract 219 Com bination of Algorithms to Decrease Preshock Pause for Automated External Defibrillators Jean Philippe Didon Irena Jekova Sarah Ménétré Todor Stoy anov Vessela Krasteva 6 Circulation 2010 122 A253 Resuscitation Sci ence Symposium Abstracts Best Original Resusci tation Science Poster Session Abstract 253 Meth od for Minimal Delay Triggering of VF Detection ...

Page 138: ...FIX Stimulation pulse Form Pulse duration Pulse rate Pulse current Refractory period Signal connection Readiness for operation Rectangle mono phase with constant current source 20 ms 5 Configurable in steps of 40 45 50 60 70 240 beats min 1 5 Configurable to 0 pacemaker Off and then from 10 200 mA 10 or 5 mA the higher value is applied 340 ms 80 b min 240 ms 80 b min Type BF defibrillation protect...

Page 139: ... maximum 16 The RR intervals are reset and the heart rate is set to zero whenever an asystole condition has been detected Response time HR measurement Change from 80 to 120 beats per minute 2 56 s Change from 80 to 40 beats per minute 8 s Reaction to an irregular rhythm A1 80 min A2 60 min A3 120 min A4 90 min except for triggers no 6 and 7 HR 90 min according to IEC specifications 60601 2 27 6 8 ...

Page 140: ...ration 2ms amplitude 4mV Duration 0 1ms amplitude 25 mV Pacemaker pulse followed by an identical pulse within 150 ms Duration 2 0ms amplitude between 4mV and 300mV Duration 0 1ms amplitude between 25mV and 300mV followed by a QRS complex Duration 2 0ms amplitude between 4mV and 300mV Duration 0 1ms amplitude between 25mV and 700mV without overshoot Duration 0 1ms amplitude between 25mV and 300mV w...

Page 141: ...e Adults Child Neonate Sys 30 255 mmHg dia 15 220 mmHg Sys 30 135 mmHg dia 15 110 mmHg Accuracy 3mmHg and 2 beats min Measuring range 150 400 mmHg Accuracy 1 mmHg or 1 whichever is greater Sampling rate 500 Hz Amplifier Type CF defibrillation protected 5 kV Zeroing Manual Measuring method Direct Sensor YSI 401 rectal oesophageal skin Amplifier Type CF defibrillation protected 5 kV Sampling rate 2 ...

Page 142: ...60 to 80 3 adults children 10 50 kg infants 3 20 kg 70 to 100 2 adults children infants 3 neonates 70 to 100 3 adults children infants neonates 70 to 100 2 adults children infants neonates 25 to 240 min 3 digits adults children infants neonates 25 to 240 min 5 digits adults children infants neonates 25 to 240 min 3 digits adults children infants neonates 1 to 40 3 adults children infants 1 to 15 1...

Page 143: ...een validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo s simulator with signal strengths of greater than 0 02 and transmission of greater than 5 for saturations ranging from 70 to 100 This vari ation equals plus or minus one standard deviation which encompasses 68 of the population The Masimo sensors have been validated for pulse rate accuracy f...

Page 144: ... 23 C Max 39 C Accuracy in standard conditions in all conditions The following specifications are valid for a dry gas at 22 5 C and 1013 40 hPa standard conditions 0 15 0 2 vol 2 of reading 15 25 no information on accuracy 0 3 kPa 4 of reading Specification of accuracy in all conditions is valid for all specified ambient conditions see page 131 Deviating from these influences are specified in the ...

Page 145: ...d ISA 4 seconds using 2 m long sampling line Protection class IP44 IRMA IP4X ISA Airway adapter IRMA Adults children adapter Infant adapter Increases dead space by less than 6 ml Pressure drop less than 0 3 cm H2O 30 LPM Increases dead space by less than 1 ml Pressure drop less than 1 3 cm H2O 10 LPM Sampling rate 1 second Sampling flow rate ISA 50 10 ml min ...

Page 146: ...0 MHz UMTS HSPA 850 900 AWS1700 1900 2100 MHz Supported SIM cards 3 and 1 8 V Data transmission GPRS class B Max transmitting power UMTS HSPA Class 3 0 25 watt GSM 850 900 MHz Class 4 2 watt GSM 1800 1900 MHz Class 1 1 watt EDGE 850 900 MHz Class E2 0 5 watt EDGE 1800 1900 MHz Class E2 0 4 watt FCC identification IC R17HE910 5131A HE910 Standards FCC IC PTCRB R TTE GCF RoHS WEEE CE ANATEL KCC CCC ...

Page 147: ...evel DEFI higher than ECG higher than SpO2 pulse Defi Always force the HR calculation on DEFI ECG Always force the HR calculation on ECG lead II SpO2 Always force the HR calculation on SpO2 pulse Audio pause at start 2min Off When this option is activated the device will always remain silent for 2 minutes at start even if an alarm occurs Periodic test frequency Daily Weekly The device wakes up by ...

Page 148: ...eter Values Description PDF Format 1p avg 1x6 10sec 12 5mms 2p 1x12 5sec 50mms 1p 2x6 5sec 25mms 1p 4x3 1 2sec 25mms 1p 1x12 10 sec 25mms Sets the PDF layout for the resting ECG report This layout will be used for the PDF sent by Email Encrypt PDF True False PDF encryption If this option is activated every Resting ECG sent by the device will be password protected with the password specified in the...

Page 149: ...shock in AED in adult mode Third shock for adults 2 4 8 15 30 50 70 90 120 150 200 Joule Sets the energy which will be delivered for the third shock in AED in adult mode First shock for children 2 4 8 15 30 50 70 90 Joule Sets the energy which will be delivered for the first shock in AED in child mode Second shock for children 2 4 8 15 30 50 70 90 Joule Sets the energy which will be delivered for ...

Page 150: ... be changed during intervention on the device Metronome rate 100cpm 110cpm 120cpm Sets the frequency of the metronome Metronome audio level High Medium Low Sets the audio level of the metronome CPR depth unit cm inch Sets the unit in which the chest compression depth value will be displayed CPR cycle duration 1min 2min 3min Sets the duration of the CPR cycle Parameter Values Description ECG curve ...

Page 151: ...ld mode Initial pressure for neonate 50 70 90 110 130 150mmHg Sets the initial cuff pressure for measurement in neonate mode Parameter Values Description SpO2 average 4 6 8 10 12 14 16sec Sets the integration time for the calculation of the displayed average value SpO2 sensitivity Normal Automatic Probe Off De tection Sets the measurement sensitivity Adaptive Probe Off Detection is optimised for t...

Page 152: ...rameter Values Description Email server Any hostname of SMTP provider example smtp myinternetprovider com Email address source The email from which the Emails are going to be sent example mymail myinternetprovider com Server port The port that is used to communicate with the SMTP server example 25 465 587 TLS False True Enables TLS SSL encryption for communication with the SMTP Server This setting...

Page 153: ...ansmission media by automatic wake up with the following scenario Never Off 10 minutes after the device has been shutted down After device power off When a external power supply is detected When device plugged on docking station Transmission media during intervention Wi Fi GSM 3G USB Ethernet The selected media will always be selected by default at manual start of the device This media can always ...

Page 154: ...xample orange m2m spec or MATOOMA or A1 net APN port Sets the APN port if required by the APN APN user Sets the APN user if required by the APN APN password Sets the APN password if required by the APN APN extra commands If required by the APN extra commands can be specified here GSM ping server 8 8 8 8 Sets the IP that will be used to test the connectivity of the device over GSM Usually it s reco...

Page 155: ...r Should the device be able to update itself over Internet typically through GSM the public IP address or hostname must be specified and not the private Example 188 165 287 137 public IP and not 192 168 200 32 private IP SUS server port 8181 Sets the port with which SUS Server is accessible This port might be different whether the device tries to connect with or without SSL encryption Example By d...

Page 156: ...ctrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines IEC 60601 1 conformity Mains power quality should be that of a typical commercial and or hospital environment Surge IEC 61000 4 5 1 kV between conductors 2 kV conductor earth IEC 60601 1 conformity Mains power quality should be that of a typical commercial and or hospital environment Voltage dips sho...

Page 157: ... 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The conformity levels within the ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and 2 5 GHz serve to minimise the probability of interferences caused by mobile portable communication equipment that accidentally happens to be in the patient environment The formula for the calcul...

Page 158: ...requency band between 80 MHz and 800 MHz between 800 MHz and 2 5 GHz 0 01 0 12 0 12 0 12 0 23 0 1 0 37 0 38 0 38 0 73 1 1 17 1 2 1 2 2 3 10 3 69 3 79 3 79 7 27 100 11 67 12 12 23 For transmitters with a max transmitting power that is not listed in the above table the recommended minimum distance d in metres m can be calculated using a formula based on the transmitter s frequency where P is the max...

Page 159: ... 4 lead patient cable 6in4 P N 0 05 0051 is necessary NIBP 0 04 0012 Cuff for neonatal soft 4 cm Arm circumference 6 12 cm 0 04 0016 Cuff for Child 8 cm Arm circumference 11 22 cm 0 04 0014 Cuff for Child 11 cm Arm circumference 16 28 cm 0 04 0013 Cuff for Adult 13 cm Arm circumference 26 33 cm 0 04 0017 Cuff for Adult 15 cm Arm circumference 33 41 cm 0 04 0015 Cuff for Adult 19 cm Arm circumferen...

Page 160: ...meda 2 310246 IBP cable assembly Medex DEFI DEFIGARD Touch 7 0 21 0040 Disposable adhesive defibrillation electrode pads for adults preconnectable with detection of shelf life by RFID 2 155067 Disposable adhesive defibrillation electrode pads for children 2 100860 ARGUS LifePoint CPR feedback sensor 6 17 0012 Adapter cable for LifePoint CPR feedback sensor 2 100519 Adhesive pad set of 5 pcs Genera...

Page 161: ...tion Biphasische Impulskurvenformen Notfall Rettungsmedizin Springer Verlag 3 458 474 Clinical experience with a low ener gy pulsed biphasic waveform in out of hospital cardiac arrest Jean Philippe Didon Guy Fontaine Roger D White Irena Jekova Johann Jakob Schmid Albert Cansell Clinical experience with a low energy pulsed biphasic waveform in out of hospital cardiac arrest Resuscitation 2008 76 pp...

Page 162: ...13 Appendix 13 4 Glossary Page 162 Art no 0 48 0227 Rev g DEFIGARD PHYSIOGARD Touch 7 ...

Page 163: ...omatic operation 114 Button test in SAED manual operation 114 Charging condenser monthly 115 Visual inspection of the device and accessories 114 I IBP IBP calibration 61 IBP settings 60 Preparing IBP measurement 59 Zeroing 60 Internal defibrillation 89 L LEDs 24 M Maintenance Lifed Item Replacement 123 Maintenance interval 112 Maintenance interval for the battery 118 Manual defibrillation 83 Manua...

Page 164: ...14 Index Page 164 Art no 0 48 0227 Rev g DEFIGARD PHYSIOGARD Touch 7 ...

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