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N i g h t i n g a l e P P M 3 U s e r ' s G u i d e

April 2019

Zoe Medical, Inc.
460 Boston Street
Topsfield, MA 01983

Nightingale Monitoring System PPM3 User's Guide
Part Number 122-0062, Revision C

©

Zoe Medical 2005 - 2019 All rights reserved

Printed in the United States of America

EC Representative: MedNet GmbH

Borkstrasse 10
48163 Muenster
Germany
Tel49 251 32266-26
Fax +49 251 32266-22

"Nightingale Monitoring System," "Nightingale MPC," "Nightingale PPM3,"
and "Personal Patient Monitor" are trademarks of Zoe Medical, Inc.

The information in this document is subject to change without notice.

This document contains proprietary information that is protected by
copyright. No part of this document may be reproduced in any manner, in
whole or in part (except for brief excerpts in reviews and scientific papers)
without the prior written consent of Zoe Medical.

Zoe Medical makes no warranty of any kind on this material, including but
not limited to, the implied warranties of merchantability and fitness for a
particular purpose. Zoe Medical shall not be liable for errors contained
herein or for incidental or consequential damages concerning the
furnishing, performance, or use of this material.

All Zoe Medical monitoring devices are intended for use only by qualified
medical personnel.

Before using any Zoe Medical monitoring device, be sure to read carefully
and understand all manuals provided with the device

.

Caution: United States Federal law restricts this device to sale by or on
the order of a physician.

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Summary of Contents for PPM3

Page 1: ...Nightingale Monitoring System PPM3 User s Guide ...

Page 2: ...pyright No part of this document may be reproduced in any manner in whole or in part except for brief excerpts in reviews and scientific papers without the prior written consent of Zoe Medical Zoe Medical makes no warranty of any kind on this material including but not limited to the implied warranties of merchantability and fitness for a particular purpose Zoe Medical shall not be liable for erro...

Page 3: ... a question or need help operating the Nightingale PPM3 please contact Zoe Medical Technical Support Email customersupport zoemedical com Phone 978 887 4013 For the latest information about answers to frequently asked questions please consult our web site www zoemedical com ...

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Page 5: ... Monitoring 3 1 3 2 Getting Started with ECG on the PPM3 3 1 3 3 Checking the ECG Signal 3 2 3 4 Standard Electrode Placement AHA 3 5 3 5 Standard Electrode Placement IEC 3 6 3 6 Electrode Placement for Paced Patients AHA 3 7 3 7 Electrode Placement for Paced Patients IEC 3 8 3 8 Verifying Proper Pacemaker Handling 3 9 3 9 ECG and Heart Rate Monitoring Messages 3 10 4 Respiration Monitoring 4 1 4 ...

Page 6: ...M3 8 2 8 3 Checking the CO2 Signal 8 4 8 4 Masimo LED Indicator 8 5 8 5 Zeroing Masimo CO2 Modules 8 5 8 6 Masimo CO2 Monitoring Messages 8 11 9 Invasive Blood Pressure Monitoring 9 1 9 1 Overview of IBP Monitoring 9 1 9 2 Checking the IBP Signal s 9 3 9 3 IBP Monitoring Messages 9 5 10 Temperature Monitoring 10 1 10 1 Checking the Temperature 10 1 10 2 Temperature Monitoring Messages 10 3 11 Work...

Page 7: ...ditions 12 9 12 3 What To Do When You Hear An Alarm Tone 12 15 12 4 Manual Self test of the Alarm System 12 16 13 Centralized Monitoring 13 1 13 1 Connecting to the MPC 13 1 13 2 Remote Control Settings 13 2 13 3 Disconnecting from the MPC 13 2 14 Viewing Trends 14 1 15 Entering Standby Mode 15 1 16 Battery Operation 16 1 17 Strip Chart Recorder Option 17 1 17 1 Basic Operation 17 1 17 2 Recorder ...

Page 8: ...viii Nightingale PPM3 User s Guide April 2019 22 6 Password Control 22 1 23 Disposal 23 1 24 Technical Data 24 1 ...

Page 9: ... Electrode Placement 3 7 Figure 18 Paced IEC Electrode Placement 3 8 Figure 19 RR Waveform and Value 4 2 Figure 20 SpO2 Waveform and Value 5 2 Figure 21 NBP Value with Interval 6 2 Figure 22 Oridion CO2 Waveform and Values 7 3 Figure 23 Integrated Pulmonary Index 7 4 Figure 24 Masimo ISA Module With Nomoline 8 1 Figure 25 Masimo IRMA Module With Airway Adapter 8 1 Figure 26 Nomoline Adpater Female...

Page 10: ... 11 25 Figure 52 Restore Department Defaults Menu 11 26 Figure 53 Setup Administration Menu 11 27 Figure 54 Setup Configuration Menu 11 28 Figure 55 Enter Password Menu 11 29 Figure 56 Setup Alarms Menu 11 30 Figure 57 Setup System Menu 11 32 Figure 58 Set Date and Time Menu 11 33 Figure 59 Save Department Defaults Menu 11 34 Figure 60 Setup NBP Interval Menu 11 35 Figure 61 Silenced Active HR Lim...

Page 11: ...s used in this document to refer to the Nightingale MPC Before using the PPM3 be sure to read carefully and understand all the chapters of this User s Guide Failure to read and understand the instructions may lead to misuse of the PPM3 which could result in harm to the patients Typographical Conventions in this User s Guide This guide contains warnings cautions and notes to help call your attentio...

Page 12: ...nea monitoring In an MRI environment Applications requiring automated arrhythmia detection Applications requiring diagnostic quality ECG WARNING DEFIBRILLATION To avoid the possibility of serious injury or death during patient defibrillation do not come into contact with patient monitor or patient cables Additionally proper placement of defibrillator paddles in relation to the ECG electrodes is re...

Page 13: ... the ESU device the ECG signals may be distorted or may disappear and Lead Fail or Noise alarms might be present The signal should return once the ESU activation stops When activating the device using the SpO2 parameter as the heart rate source rather than the ECG parameter to determine heart rate may be clinically preferred Only use accessories approved by Zoe Medical for use with the Nightingale...

Page 14: ...to PPM3 Network installation must be performed by service personnel that are authorized by Zoe Medical Connection of the PPM3 to a network that includes other equipment could result in previously unidentified risks WARNING BATTERY HANDLING The Nightingale PPM3 contains a lithium ion coin cell battery and transport battery pack The following precautions should be taken regarding these batteries Do ...

Page 15: ...ow Battery alarm indication occurs Failure to do this can lead to an interruption of monitoring CAUTION Do not operate the Nightingale PPM3 near high frequency emissions e g microwaves Note The battery may need to be recharged if the Nightingale PPM3 has been powered off for an extended period of time See the Battery Operation chapter of this manual for details regarding the battery Note The Night...

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Page 17: ...nd a description of how this User s Guide relates to other Nightingale Monitoring System documents This chapter also provides a basic overview of the PPM3 user interface and a list of the PPM3 s main features 1 1 System Diagram The main components of the Nightingale Monitoring System are shown in the following diagram Figure 1 Nightingale Monitoring System The PPM3 component serves as the bedside ...

Page 18: ... in a stand alone mode independent of the MPC 1 2 Scope of this User s Guide This User s Guide provides healthcare professionals the information required for the safe and effective use of the Nightingale PPM3 For information about how to use the MPC please consult the Nightingale MPC User s Guide ...

Page 19: ...April 2019 Nightingale PPM3 User s Guide 1 3 Overview 1 3 PPM3 Diagrams Figure 2 PPM3 Front View Control knob Keypad Power Indicator ...

Page 20: ...1 4 Nightingale PPM3 User s Guide April 2019 Overview Figure 3 PPM3 Rear View Slot for Mounting Tab On Off Button Battery Charging Indicator ...

Page 21: ...PM3 Left View Other Medical Device OMD Connector Note Labeled EtCO2 in later production units SpO2 Connector NBP Connector ECG Connector TEMP Connector IBP Connector CO2 Input Connector CO2 Exhaust Dual Channel Recorder Connector with Oridion Microstream CO2 and IBP ...

Page 22: ...1 6 Nightingale PPM3 User s Guide April 2019 Overview Figure 5 PPM3 Right View Power Connector to Power Supply Ethernet Network Connector EMR System or MPC Central Station Serial Interface Connector ...

Page 23: ...at 45 angle to the case and press into monitor Figure 6 Partially Engaged Power Connector When fully engaged rotate the connector body so that that it is parallel to the case Figure 7 Fully Engaged Power Connector Power connector is shown fully engaged in the locked position To remove the power connector reverse the above steps ...

Page 24: ...terface makes use of a control knob and a set of keys on the front panel keypad for input and a display screen and speaker for output The front panel looks like the following diagram Figure 8 PPM3 Front Panel NBP START STOP PRINT ALARM SILENCE TRENDS NBP INTERVAL STANDBY SETUP MAIN SCREEN POWER ...

Page 25: ... in Interval Mode as well as to enable disable NBP Interval Mode see the NBP Monitoring chapter for more details You can use the NBP START STOP key to start a NBP measurement if one is not currently running or to stop a NBP measurement if one is currently running You can use the STANDBY key to place the monitor into Standby Mode or when you are preparing to transport or discharge a patient You can...

Page 26: ...eter Area is actually in two parts one to the right of the waveform area and one below it The Parameter Area shows the current values of the monitored parameters The Patient Information Area is at the bottom right corner of the display The Message Area is at the bottom of the display Alarm and technical condition messages are displayed here One message is displayed at a time If multiple messages a...

Page 27: ...spond in case there is an alarm such as HR getting too high The chapters in this User s Guide explain the details of all the main features of the PPM3 These cover the basic monitoring tasks you may need to do when using the PPM3 The main features covered in this User s Guide are as follows ECG and Heart Rate Monitoring HR Respiration Monitoring RR Pulse Oximetry Monitoring SpO2 and PR Non Invasive...

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Page 29: ...o the Nightingale MPC 4 ECG Cables if you will be monitoring ECG or Impedance Respiration 5 ECG Electrodes if you will be monitoring ECG or Impedance Respiration 6 SpO2 Sensor Extender Cable if you will be monitoring SpO2 7 CO2 sampling lines or airway adapter if your monitor is configured with a CO2 Capnography monitoring module 8 Invasive pressure Y adapter only needed if your monitor is configu...

Page 30: ...g a custom adapter bracket that is described in the accessories chapter The maximum height of a roll stand mount is 100 cm Several types of table stand are also available for the PPM3 as described in the accessories chapter WARNING Please follow installation instructions provided with mounting hardware to avoid possible hazard of device falling ...

Page 31: ... PPM3 Power Supply into a live outlet 2 Plug the Power Cable Plug into the Power Connector on the back of the PPM3 right hand side The green Battery Charging LED on the back of the PPM3 should now be illuminated 3 Press the On Off Button on the back of the PPM3 After pressing the On Off Button you should hear a chirp accompanied by a flash of the screen The Power Indicator LED on the front of the ...

Page 32: ...2 4 Nightingale PPM3 User s Guide April 2019 Getting Started Figure 10 PPM3 Startup Screen ...

Page 33: ...rted To power down the PPM3 press the On Off Button until the following screen appears The rest of the power down process will be completed automatically The power supply should remain connected for the battery to be recharged Figure 11 PPM3 Shutdown Screen ...

Page 34: ... Part Number 421 0052 or an equivalent cable configured as shown below One end of the cable has a DB 9 connector that interfaces to a standard PC serial port The other end of the cable connects to an RJ45 port on the right side of the PPM3 Note To connect to PC s that do not have built in DB9 connectors a third party USB to serial cable of the type recommended by the EMR vendor may be used ...

Page 35: ...April 2019 Nightingale PPM3 User s Guide 2 7 Getting Started RJ45 Pin Signal DB9 Pin 1 RX to monitor 2 2 TX from monitor 3 3 Ground 5 4 NC 1 5 NC 4 6 NC 6 7 NC 7 8 NC 8 ...

Page 36: ...software Note For complete details of the communications protocol the PPM3 uses for interfacing with EMR systems please refer to the document PPM3 Data Transfer Interface Part Number 122 0064 Connecting to the Nightingale MPC Central Station Connection to the Nightingale MPC Central Station requires a custom Network Cable from Zoe Medical Part Number 421 0053 To connect the PPM3 to a Nightingale M...

Page 37: ...d as before Figure 12 New Patient Screen With Previous Patient Alternatively if you will be monitoring a different patient as compared to when the PPM3 was last powered down select Yes to discharge the old patient from the PPM3 This will clear the Patient Information Area and bring up the Main Screen as shown in Figure 12 Note See the Working With Menus chapter for details on how to use the contro...

Page 38: ...ith No Patient Admitted The patient information area will not be filled in until the new patient is admitted via the Patient Information Menu see the Working With Menus chapter or the MPC The waveforms and parameter values will not be displayed until you connect the PPM3 to the patient ...

Page 39: ... startup tones sound two tones followed by two higher pitched beeps 3 Confirm that the power on LED is lit on the front panel 4 Confirm that the display comes up showing the home screen 5 If monitoring SpO2 connect sensor confirm that LED is lit on sensor 6 Press NBP Start Stop key confirm that pump starts 7 Press NBP Start Stop key again confirm that pump stops If you notice any problem in going ...

Page 40: ...e waveform displayed on the PPM3 shows that the connection was good When connected to the MPC you should verify that the patient name is displayed in the name area of the PPM3 Main Screen If the patient s name is too long to fit in this area you should verify that the patient s initials are displayed Before leaving the patient make sure that the PPM3 the PPM3 Power Supply and all the cables are se...

Page 41: ...re cable with lead II monitoring 5 wire cable with leads I II III V AVL AVR and AVF Calculating the average heart rate HR in beats per minute based the top displayed ECG lead or Lead II if no ECG lead is displayed Detecting asystole and ventricular fibrillation based on heart rate lead Pacer pulse detection performed on Lead II Generating an audible pulse tone for each detected beat The Nightingal...

Page 42: ...g a circular motion on the adhesive area first then pressing on the gel area gently to avoid squeezing out the gel Please refer to the diagrams on the following pages for guidance on proper electrode placement You should change the electrodes every 24 48 hours to maintain a good quality ECG signal 4 Connect the ECG cable lead set to the electrodes and to the PPM3 3 3 Checking the ECG Signal When y...

Page 43: ...n the Working With Menus chapter WARNING Conductive parts of the ECG patient cables electrodes and associated connections of type CF applied parts including the neutral conductor of the patient cable and electrode should not come into contact with other conductive parts including earth ground WARNING Read safety instructions provided with a defibrillator The PPM3 is designed to withstand defibrill...

Page 44: ...ourced from ECG default The color changes to cyan or green respectively when sourced from SpO2 or an ART labeled IBP Note If an ECG waveform is not displaying on the PPM3 follow the instructions in the chapter Working With Menus to select one or more ECG waveforms for display Note Visually inspect the ECG cables on a daily basis and follow the instructions in the Cleaning and Maintenance chapters ...

Page 45: ...HA Electrode Placement 1 Position the right arm RA electrode on the right mid clavicular line directly below the clavicle 2 Position the left arm LA electrode on the left mid clavicular line directly below the clavicle 3 Position the right leg RL electrode on the right mid clavicular line 6th and 7th intercostal space 5 lead cable only 4 Position the left leg LL electrode on the left mid clavicula...

Page 46: ...ard IEC Electrode Placement 1 Position the right arm R electrode on the right mid clavicular line directly below the clavicle 2 Position the left arm L electrode on the left mid clavicular line directly below the clavicle 3 Position the neutral N electrode on the right mid clavicular line 6th and 7th intercostal space 5 lead cable only 4 Position the left leg F electrode on the left mid clavicular...

Page 47: ... be available Figure 17 Paced AHA Electrode Placement 1 Position the right arm RA electrode on the right mid clavicular line 5th intercostal space 2 Position the left arm LA electrode on the left mid clavicular line directly below the clavicle 3 Position the right leg RL electrode on the right mid clavicular line 6th and 7th intercostal space 5 lead cable only 4 Position the left leg LL electrode ...

Page 48: ... will be available Figure 18 Paced IEC Electrode Placement 1 Position the right arm R electrode on the right mid clavicular line 5th intercostal space 2 Position the left arm L electrode on the left mid clavicular line directly below the clavicle 3 Position the neutral N electrode on the right mid clavicular line 6th and 7th intercostal space 5 lead cable only 4 Position the left leg F electrode o...

Page 49: ...of each ECG waveform channel on the Nightingale PPM3 and the MPC These tick marks occur at the point where the PPM3 detects a pacer pulse The PPM3 rejects pacer pulses rather than calling them QRS s per IEC 60601 2 27 However it is important to keep paced patients under close surveillance and not to entirely rely on rate meters for these patients as indicated in the warning at the start of this ma...

Page 50: ...R asystole ASY No QRS detected for last 4 seconds Check the patient and provide any necessary clinical care Check the ECG lead being used to calculate the heart rate the top displayed lead make sure that the QRS amplitude on this lead is at least 0 5 mV Change to another ECG lead to get adequate QRS amplitude Reposition or change electrodes if no lead gives adequate QRS amplitudes Remember the imp...

Page 51: ...ake sure all the lead wires are still connected to the electrodes Check to make sure the lead wires are securely connected to the PPM3 Check to make sure there are no broken lead wires Turn monitor off then back on If message persists contact Zoe technical support Press ALARM SILENCE in the event of intentional removal by clinician HR artifact Patient movement Electrical noise from auxiliary equip...

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Page 53: ...e RR in respirations per minute Displaying the respiration waveform continuously The same electrodes are used for both ECG and Respiration monitoring Note PPM3 models configured with capnography modules are also able to calculate RR from the CO2 waveform See the CO2 monitoring chapter in this user s guide for more information 4 2 Getting Started with Respiration on the PPM3 To begin monitoring Res...

Page 54: ...eases and that the RR waveform and parameter return The Respiration Monitoring settings and specifications for the Nightingale PPM3 may be found in the PPM3 Monitor Settings and Technical Data chapters Procedures for changing configuration settings such as enabling alarms or adjusting alarm limits may be found in the Working With Menus chapter WARNING Operating the Nightingale PPM3 with RR limit a...

Page 55: ...in the respiration signal can be quite pronounced in pediatric patients This can cause the respiration rate to be artificially high approaching the heart rate To reduce cardiogenic artifact move the White RA electrode AHA lead designation or the Red R electrode IEC lead designation from the right clavicle down to the right mid clavical line 4th intercostal space ...

Page 56: ...uxiliary equipment if possible Check to make sure electrodes are still securely attached to the patient and reattach if necessary Remember the importance of good skin preparation techniques RR lead off blank Unplugged cable Broken cable Loose lead wire Faulty lead wire Dried out electrode Inoperable respiration detection circuit Intentional removal by clinician Check to make sure electrodes are st...

Page 57: ...y monitoring capabilities of the Nightingale PPM3 include Measuring the functional oxygen saturation of the patient s arterial hemoglobin SpO2 Calculating the patient s pulse rate PR Displaying the pulse oximetry waveform plethysmograph continuously Generating an audible pulse tone for each detected pulse with the pulse tone pitch being tied to the SpO2 value higher pitch used for higher SpO2 5 2 ...

Page 58: ...y that the alarm is no longer active and that SpO2 monitoring continues normally The Pulse Oximetry Monitoring settings and specifications for the Nightingale PPM3 may be found in the PPM3 Monitor Settings and Technical Data chapters Procedures for changing configuration settings such as sourcing the pulse rate PR from SpO2 enabling a pulse tone or adjusting alarm limits may be found in the Workin...

Page 59: ...SpO2 signal is obtained This is intended to reduce nuisance alarms during initial patient connection CAUTION Read instructions provided with the sensor to understand the best application technique and all relevant safety information CAUTION Do not apply the sensor on the same limb as the NBP cuff During blood pressure measurements the perfusion is temporarily reduced which can result in inaccurate...

Page 60: ...tester The accuracy of the SpO2 parameter in the Nightingale PPM3 has been validated with a co oximeter per ISO 80601 2 61 5 4 Pediatric Considerations It is important to select a SpO2 sensor that is appropriate for the weight of the patient For example a clean pulse oximetry waveform may not be obtainable when an adult sensor is used on a small child Weight range information can be found in the p...

Page 61: ...nical care Change the alarm limit if it is no longer clinically appropriate HR lower limit Note When PR is sourced from SpO2 the Pulse Rate is labeled in cyan as HR SpO2 in the HR parameter box PR alarm conditions annunciate as HR alarms number The patient s pulse rate has fallen below the current lower alarm limit Check the patient and provide any necessary clinical care Change the alarm limit if...

Page 62: ...the sensor on a smaller finger Remove any nail polish that may be interfering with the red light Replace the SpO2 sensor HR weak signal Note When PR is sourced from SpO2 the Pulse Rate will be labeled in cyan as HR SpO2 in the HR parameter box A weak pulse rate signal will annunciate as HR weak signal Poor perfusion Large tissue mass Nail polish Bad SpO2 sensor Check the patient and provide any ne...

Page 63: ...of the Nightingale PPM3 include Calculating the patient s systolic mean and diastolic blood pressures Spot check and automatic measurement intervals 6 2 Getting Started with NBP on the PPM3 To begin NBP monitoring use the following procedure 1 Attach the NBP cuff to the patient Please refer to the Accessories chapter for a list of Zoe Medical approved NBP cuffs for use with the Nightingale PPM3 In...

Page 64: ...to stop it simply press the NBP START STOP key again 5 To configure the PPM3 to take measurements automatically at a preset interval press the NBP INTERVAL key on the front panel or select NBP Interval in the Setup NBP menu Once changed from something other than Off the PPM3 will display the message NBP Interval N minutes in the message area where N is the interval See Section 10 2 3 NBP INTERVAL ...

Page 65: ...essure NBP cuffs approved by Zoe Medical for use with the Nightingale PPM3 See the Accessories chapter WARNING The cuff should fit snugly according to current AHA guidelines Use the correct size cuff for the intended limb see indication of cuff size in cm printed on the cuff of the patient The terminology printed on some BP cuffs like child adult thigh etc is only an indication of the size of the ...

Page 66: ...Avoid applying the cuff to a limb with a catheter arterio venous shunt or infusion pump applied The cuff pressure could produce damage to the tissues surrounding the catheter shunt or the infusion needle or compromise the infusion flow WARNING Avoid placing the blood pressure cuff on the arm next to where a patient has had a mastectomy WARNING To avoid the potential for spread of disease or infect...

Page 67: ...ronic or automated sphygmomanometers Note The Auto Mode setting is remembered between power cycles However the PPM3 does not start Auto Mode NBP measurements after power up until the NBP Start Stop key is pressed This tells the PPM3 that the cuff has been applied to the patient and that NBP monitoring should commence Note NBP readings are not continuous but are updated each time a NBP measurement ...

Page 68: ...ous systolic pressure value to select the inflation cuff pressure The PPM3 automatically senses when an infant cuff is attached and limits the maximum cuff pressure to 180 mmHg as opposed to 270 mmHg for larger cuffs 6 5 Hypertensive Considerations For hypertensive patients e g systolic pressure greater than 220 mmHg it may be necessary to repeat a NBP measurement if the first attempt is unsuccess...

Page 69: ... below the current lower alarm limit Check the patient and provide any necessary clinical care Change the alarm limit if it is no longer clinically appropriate NBPd upper limit number The patient s diastolic pressure has risen above the current upper alarm limit Check the patient and provide any necessary clinical care Change the alarm limit if it is no longer clinically appropriate NBPm lower lim...

Page 70: ... hemodynamic interference Check the cuff and hose for signs of damage NBP cuff leak Leaky cuff or hose Cuff not applied to patient Check for leaks in the cuff or hose and replace if necessary Check that cuff and hose are connected to the monitor Check that cuff is applied to patient NBP blocked hose check patient Pinched Hose Check the patient and insure that the cuff is deflated Check for kinks o...

Page 71: ...ted patients The CO2 monitoring capabilities of the Nightingale PPM3 configured with Oridion Microstream capnography include Measuring the patient s end tidal carbon dioxide ETCO2 Measuring the patient s fractional inspired carbon dioxide FICO2 Calculating the patient s respiration rate RRc from CO2 Calculating the patient s Integrated Pulmonary Index IPI Displaying CO2 waveform capnograph continu...

Page 72: ...cure the CO2 pump should start and the CO2 Warming Up message will briefly appear 5 Securely connect all components and check connections for leaks according to standard clinical procedures 6 Connect the patient applied end of the sampling line to the patient as per instructions included with the CapnoLine or FilterLine packaging 7 The CO2 waveform and numeric parameter values should appear within...

Page 73: ...ings and specifications for the Nightingale PPM3 may be found in the PPM3 Monitor Settings and Technical Data chapters Procedures for changing configuration settings such as adjusting alarm limits changing the waveform size amplitude setting the apnea time or enabling or disabling IPI etc may be found in the Working With Menus chapter 7 4 Integrated Pulmonary Index The Integrated Pulmonary Index I...

Page 74: ... means that no low or high CO2x alarm conditions will produce alarm notifications Use this feature with extreme caution Patients must be closely observed if CO2x limit alarms are disabled WARNING When monitoring an anesthetized patient in an operating room environment it is recommended to connect the CO2 exhaust port of the Nightingale PPM3 to the hospital s waste gas scavenging system so as to pr...

Page 75: ...o ensure that the airway adapter does not interfere with the functioning of the suction catheter WARNING Do not cut or remove any part of the sampling line Cutting the sampling line could lead to erroneous readings WARNING If too much moisture enters the sampling line i e from ambient humidity or breathing of unusually humid air the message Purging Line will appear in the message area If the sampl...

Page 76: ... is blocked the monitor s CO2 pump will stop pumping the patient s breath into the monitor for testing Follow the instructions that appear in the Troubleshooting chapter of this manual First disconnect and reconnect the sampling line If the message still appears disconnect and replace the line Once a working sampling lie is attached to the monitor the pump will automatically resume operation Note ...

Page 77: ...rm limit if it is no longer clinically appropriate RR lower limit number or 0 number The patient s respiration rate RRc has fallen below the current lower alarm limit 0 No breath has been detected for the user configurable apnea time Check the patient and provide any necessary clinical care Change the alarm limit if it is no longer clinically appropriate RR upper limit number The patient s respira...

Page 78: ...cally required CO2 Occluded Line CO2 sampling line cannot be cleared due to moisture or other obstruction Replace the sampling line If connected to scavenging system disconnect to see if message disappears CO2 Purging Line Microstream module is trying to clear excess humidity If the message disappears resume usage If the purging operation is unsuccessful or the Occluded Line message appears discon...

Page 79: ...y passed through a moisture eliminating wick bacterial filter and then through an infrared spectrometer which is housed within the small ISA module Based on the amount of infrared light absorbed the amount of CO2 present and the respiration rate can be determined The Masimo IRMATM utilizes an approach known as mainstream capnography in which a disposable airway adapter is inserted directly in line...

Page 80: ...itoring has not been enabled indicated by the presence of impedance respiration box with blue labels underneath the green HR parameter box press the SETUP key on the PPM3 scroll the control knob to Parameters press the knob press on the highlighted ETCO2 Enabled scroll to Yes and press the knob Press the Main Screen key to apply the changes Now the CO2 waveform area and parameter box should appear...

Page 81: ...a ISA sidestream Connect an appropriate nasal cannula or other sampling line with a male Luer Lock fitting to the Nomoline adapter Apply the other end to the patient according to the instructions supplied Note Using sampling lines or cannulas with an inner diameter larger than 1 mm will increase the ISA s total response time b IRMA mainstream Connect the IRMA airway adapter between the breathing c...

Page 82: ...asis you may use the following approach First either connect the patient to the Nightingale PPM3 using the above procedure or continue as follows with a patient who is already being monitored Then enable the alarms ETCO2 RRc and FICO2 Next lower the ETCO2 upper alarm limit setting below its current value Verify that ETCO2 upper limit annunciates as a medium grade alarm Press the ALARM SILENCE key ...

Page 83: ...A airway adapter onto the IRMA module without connecting the airway adapter to the patient circuit and then pressing the Zero Set menu button in the Setup CO2 menu An alert tone will sound when the zeroing procedure has started along with a CO2 zeroing message The alert tone will resound when the zeroing procedure has completed Special care should be taken to avoid breathing near the airway adapte...

Page 84: ... of patient entanglement or strangulation WARNING ISA Do not lift the ISA or the PPM3 monitor by the sampling line as it could disconnect from the ISA or PPM3 causing the ISA or PPM3 to fall on the patient WARNING ISA Dispose Nomoline Family sampling lines in accordance with local regulations for biohazardous waste WARNING ISA Use only airway T adapters with the sampling point in the center of the...

Page 85: ... message appears on the PPM3 WARNING ISA No modification of this equipment is allowed without authorization of the manufacturer If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe operation WARNING ISA ISA sidestream gas analyzers are not appropriate for MRI environments WARNING ISA During MRI scanning the ISA must be placed outside the MRI s...

Page 86: ...es in liquid WARNING ISA Do not operate the ISA sidestream gas analyzer if the enclosure is damaged WARNINGS IRMA The IRMA probe is intended for use by authorized and trained medical personnel only WARNINGS IRMA The IRMA probe is intended only as an adjunct in patient assessment It must be used in conjunction with other assessments of clinical signs and symptoms WARNINGS IRMA The IRMA probe must n...

Page 87: ... windows or oxygen sensor port always position the IRMA probe in a vertical position with the LED pointing upwards WARNINGS IRMA Do not use the IRMA airway adapter with metered dose inhalers or nebulized medications as this may affect the light transmission of the airway adapter windows WARNINGS IRMA Incorrect probe zeroing will result in false gas readings WARNINGS IRMA Incorrect agent selection ...

Page 88: ... of a licensed healthcare practitioner CAUTION IRMA Never sterilize or immerse the IRMA probe in liquid CAUTION IRMA IRMA airway adapters are non sterile devices Do not autoclave the devices as this will damage them CAUTION IRMA Do not apply tension to the probe cable CAUTION IRMA Do not operate the IRMA probe outside the specified operating environment CAUTION IRMA U S only Federal law restricts ...

Page 89: ...ny necessary clinical care Change the alarm limit if it is no longer clinically appropriate RR lower limit number or 0 number The patient s respiration rate RRc has fallen below the current lower alarm limit 0 No breath has been detected for the user configurable apnea time Check the patient and provide any necessary clinical care Change the alarm limit if it is no longer clinically appropriate RR...

Page 90: ...thin IRMA airway adapter has become fogged or blocked 2 IRMA airway adapter has become unplugged from the sensor Replace or reconnect the airway adapter CO2 Needs Zeroing CO2 zero offset needs to be removed Follow the zeroing procedure provided in this chapter CO2 Check Sensor ISA module or IRMA sensor have reported an internal error Disconnect the module or adapter from the PPM3 and then reconnec...

Page 91: ...nsducer is a piezo resistive device that converts the pressure signal to a voltage The monitor interprets the voltage signal so that pressure data and pressure waveforms can be displayed The IBP monitoring capabilities of the Nightingale PPM3 include Measuring the patient s pressures across two IBP channels P1 and P2 Calculating the P1 and P2 values in mmHg using either Sys Dia Mean or Mean Sys Di...

Page 92: ...ory Part Number 421 6102 Then connect the invasive pressure cable s to the Y cable while keeping track of the P1 and P2 labels on Y cable connectors to make sure you have the correct IBP cable connected to the correct port on the Y cable Note From this point complete steps 3 through 9 first for P1 Repeat substituting P2 for P1 as required 3 Connect each transducer manifold to the correct invasive ...

Page 93: ...de alarm Press the ALARM SILENCE key and return the upper alarm limit to its previous value Verify that the alarm is no longer active Alternatively when first connecting an IBP unplug the IBP cable from the Y cable after completing step 7 above Verify that P1 unplugged or P2 alarm annunciates as a low grade alarm Plug the cable back in Verify that the alarm ceases Then re zero the pressure and con...

Page 94: ... the patient connections touches any electrically conductive material including earth WARNING Only use invasive pressures transducers that can withstand defibrillation as required by ANSI AAMI BP22 standard WARNING Mechanical shock to the invasive blood pressure transducer may cause severe shifts in zero balance and calibration and cause erroneous readings Note To reduce nuisance alarms the invasi...

Page 95: ...not due to artifact by checking the position of the patient cables and transducer Zero set the pressure if necessary Change the alarm limit if it is no longer clinically appropriate P1 signal out of range low P1 signal out of range high The invasive signal is out of range Verify the position of the patient cables and transducer Zero set the pressure if necessary P1 unplugged IBP cable or transduce...

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Page 97: ...ature Probe Instructions P N 122 0030 For surface application Apply the probe to a location on the patient that stays fairly dry the abdomen is recommended To ensure good adhesion clean the skin with alcohol before hand Tape the probe and cable to the patient s skin 3 Connect the temperature probe cable to the PPM3 Note Probe performance is unaffected when used without a probe cover Note Follow th...

Page 98: ...Verify that the alarm is no longer active and that temperature monitoring continues normally Alternatively before initiating temperature monitoring with a patient you can verify TEMP alarm functionality by rubbing a probe with cover applied between your hands until an upper limit alarm is generated The Temperature Monitoring settings and specifications for the Nightingale PPM3 may be found in the ...

Page 99: ...t Check the patient and provide any necessary clinical care Change the alarm limit if it is no longer clinically appropriate TEMP unplugged blank Temperature probe disconnected Check to make sure the temperature probe is connected to the temperature cable Check to make sure the temperature cable is connected to the PPM3 TEMP out of range The patient s temperature has risen above the maximum value ...

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Page 101: ...m When the PPM3 is displaying the Main Screen turning the knob highlights the various parameter boxes in turn Selecting a given parameter box brings up a menu that allows you to change settings related to that parameter When you have entered the change you wanted to make select OK If you select Cancel the menu will disappear and the setting will keep the value it had when you first brought up the ...

Page 102: ...wer Limit HR PR alarm lower limit Upper Limit HR PR alarm upper limit Auto Auto adjust lower limit to 80 of current value and upper limit to 125 of current value Alarms On Enables Yes or disables No alarms Print on Alarm Print a strip chart summary upon alarm condition ECG Lead Select lead used for HR processing Size Changes display amplitude of ECG waveform ...

Page 103: ... parameter box appearance when HR Source is SpO2 or ART Pulse Tone Source Enables audible tones for each detected beat When source is SpO2 the tone pitch varies higher SpO2 higher pitch ECG Filter Set to either Monitor 0 67 40 Hz or Diagnostic 0 05 40 Hz Cal Injects a simulated 1 mv calibration pulse into the ECG waveform Figure 32 HR PR Values Sourced From SpO2 or ART ...

Page 104: ...tup RR Menu Setting Description Lower Limit RR alarm lower limit Upper Limit RR alarm upper limit Auto Auto adjust lower limit to 80 of current value and upper limit to 125 of current value Alarms On Enables Yes or disables No alarms Print on Alarm Print a strip chart summary upon alarm condition ...

Page 105: ...Auto adjust SpO2 lower limit to 95 of current value and set upper limit to 100 Alarms On Enables Yes or disables No alarms Print on Alarm Print a strip chart summary upon alarm condition HR Source Calculate HR PR from ECG default SpO2 or ART labeled IBP See Figure 28 for HR PR parameter box appearance when HR Source is SpO2 or ART Pulse Tone Source Enables audible tones for each detected beat When...

Page 106: ...ghtingale PPM3 User s Guide April 2019 Working With Menus SpO2 the tone pitch varies higher SpO2 higher pitch SpO2 Alarm Acknowledge Clears SpO2 alarms until a patient is once again detected at the SpO2 sensor ...

Page 107: ...scription Lower Limit NBP systolic mean diastolic alarm lower limits Upper Limit NBP systolic mean diastolic alarm upper limits Auto Auto adjust NBP lower limits to 80 of current values and upper limits to 125 of current values Alarms On Enables Yes or disables No alarms Print on Alarm Print a strip chart summary upon alarm conditions ...

Page 108: ...tart Interval Mode NBP measurements after power up until the NBP Start Stop key is pressed This tells the PPM3 that the cuff has been applied to the patient and that NBP monitoring should commence Initial Inflation Pressure The NBP cuff is inflated to this pressure if a systolic pressure from previous measurement is not displayed Otherwise 40 mmHg is added to the previous systolic pressure for the...

Page 109: ... limits Auto Auto adjust lower limits to 80 of current values and upper limits to 125 of current values Alarms On Enables Yes or disables No alarms Print on Alarm Print a strip chart summary upon alarm conditions Size Changes display amplitude of CO2 waveform Apnea Time Time since last breath before RRc alarm annunciates IPI Enabled Enables Yes or disables No Integrated Pulmonary Index Age Range R...

Page 110: ...o 80 of current values and upper limits to 125 of current values Alarms On Enables Yes or disables No alarms Print on Alarm Print a strip chart summary upon alarm conditions Size Changes display amplitude of CO2 waveform Apnea Time Time since last breath before RRc alarm annunciates O2 Compensation Adjust CO2 value based on this range O2 in fresh gas N2O Compensation Adjust CO2 value based on this...

Page 111: ...April 2019 Nightingale PPM3 User s Guide 11 11 Working With Menus Monitoring chapter CO2 Alarm Acknowledge Clears CO2 alarms and parameter values until a patient is once again detected at the CO2 sensor ...

Page 112: ...arm upper limits Auto Auto adjust lower limits to 80 of current values and upper limits to 125 of current values Alarms On Enables Yes or disables No alarms Print on Alarm Print a strip chart summary upon alarm conditions Label Changes label from default to ART PAP or CVP Size Changes display amplitude of P1 waveform Format Displays either Sys Dia or Mean numeric value in larger font Zero Set Zero...

Page 113: ...uto adjust lower limit to 95 of current value and upper limit to 105 of current value Alarms On Enables Yes or disables No alarms Print on Alarm Print a strip chart summary upon alarm conditions Note When you change the TEMP Units setting F or C from the Setup System menu recheck the TEMP alarm limit settings as some round off error may occur when the limit settings are switched to the new units o...

Page 114: ...ing With Menus 11 2 Front Panel Keypad Menus 11 2 1 SETUP Key and Submenus When you press the SETUP key on the PPM3 front panel the top level Setup Menu appears Figure 40 SETUP Key Menu This menu gives you access to a variety of functions and sub menus ...

Page 115: ...dicated in the message area with a timer indicating when alarm monitoring will resume There is also an alarms paused symbol displayed to the left of the message area Figure 41 Main Screen With Alarms Paused Message Timer WARNING Pausing all alarms pauses all alarm conditions including lethal arrhythmias Asystole and VFib Use this feature with extreme caution as alarm checking is suspended for all ...

Page 116: ...m the Setup Parameters Menu appears Figure 42 Setup Parameters Menu The Setup Parameters menu allows you to enable ETCO2 CO2 Capnography and IBP Invasive Blood Pressure Monitoring if these components are present in your Nightingale PPM3 monitor but have not been turned on from a software standpoint ...

Page 117: ...de 11 17 Working With Menus If you change Numbers Only to Yes the Main Screen will display all the monitored physiological parameters with large numbers instead of sharing some of the space with waveforms Figure 43 Numbers Only Main Screen ...

Page 118: ...veforms Menu The Setup Waveforms Menu allows you to choose which physiological waveforms to display in each of the three possible waveform display channels five with two IBP channels enabled The range of possible choices for the waveform display channels may be found in the Waveform Settings table in the PPM3 Monitor Settings chapter For ECG and CO2 waveforms you can also choose what size amplitud...

Page 119: ...veforms to show where the monitor detects beats Figure 45 Setup Waveform Menu with IBPs You may also choose the size amplitude of the invasive pressure waveforms Note When a communications link with the MPC is established these settings will be overridden by those that are received from the MPC In the case where the sweep speed is set to 50 mm sec at the MPC the PPM3 will use a 25 mm sec sweep spe...

Page 120: ...udio Menu appears Figure 46 Setup Audio Menu The Speaker Volume allows you to change the volume for alarm tones The HR PR Tone Volume allows you to change the volume for pulse tones You can also enable the HR PR Tone and select the source from this menu just as you can from the Setup HR and Setup SpO2 menus ...

Page 121: ...at once for your convenience Any changes made here are also reflected in the individual parameter box menus and vice versa The factory default values and ranges of possible values for all alarm limits may be found in the Parameter Settings table of the PPM3 Monitor Settings chapter When you select the Auto feature for a parameter s alarms the PPM3 automatically adjusts the upper and lower limits b...

Page 122: ...t rules FICO2 N R Changed to 125 of the current parameter value or the nearest allowable value given alarm limit rules IPI Changed to 75 of the current parameter value or the nearest allowable value given the alarm limit settings rules N R SpO2 Changed to 95 of the current parameter value or the nearest allowable value given alarm limit rules Set to 100 Temp Changed to 95 of the current parameter ...

Page 123: ...April 2019 Nightingale PPM3 User s Guide 11 23 Working With Menus Figure 48 Setup Alarms Menu Screen 2 ...

Page 124: ...11 24 Nightingale PPM3 User s Guide April 2019 Working With Menus Figure 49 Setup Alarms Menu Screen 3 ...

Page 125: ...htingale MPC entries made here when admitting a patient will be transmitted to the MPC Also if a patient is admitted at the MPC and assigned to a particular PPM3 the information will be transmitted to this menu The Patient Information Menu is also the place to change the patient type from Adult to Pediatric As shown in the figure a symbol indicating the current patient type is displayed in the low...

Page 126: ... Department Defaults any changes made to the patient settings parameter waveform settings for the current patient will be restored to the previously saved Department Default values Or if no Department Defaults have previously been created the settings will be restored to the Factory Default values found in the PPM3 Monitor Settings chapter Department Defaults can only be saved from within the pass...

Page 127: ...ale PPM3 User s Guide 11 27 Working With Menus If you select the Administration item the Setup Administration Menu appears Figure 53 Setup Administration Menu Each of the selections on this menu leads to further submenus ...

Page 128: ...With Menus If you select the Configuration item the Setup Configuration Menu appears Figure 54 Setup Configuration Menu The Setup Configuration menu provides a way of seeing what hardware and software versions are currently installed on the Nightingale PPM3 ...

Page 129: ...he PPM3 brings up the Enter Password Menu Figure 55 Enter Password Menu This menu allows you to enter a password to proceed to the Setup Alarms or Setup System menu The password for these menus is located at the end of the Maintenance and Storage chapter of this document Note The Service and Factory setup menus are intended to be used by trained service and production personnel ...

Page 130: ...11 30 Nightingale PPM3 User s Guide April 2019 Working With Menus The Setup Alarms Menu allows changes to certain aspects of alarm handling Figure 56 Setup Alarms Menu ...

Page 131: ...l Setup menu Can Suspend All Alarms This setting controls if the clinician is able to suspend all alarms including lethal arrhythmias Asystole and VFib Alarm Validation Enables disables alarm validation if enabled limit alarms are not annunciated until values have been out of limits for a set period of time see Managing Alarms chapter Second Speaker Time Time that elapses while an alarm tone in so...

Page 132: ...escription Temp Units Allows you to choose F or C Height Units Allows you to choose inches in or centimeters cm Weight Units Allows you to choose pounds lb or kilograms kg Print Location When connecting to the MPC allows you to specify where hard copy reports are printed Bedside Only Central Only Bedside And Central NOTE When a communications link with the MPC is established these Units settings w...

Page 133: ...April 2019 Nightingale PPM3 User s Guide 11 33 Working With Menus If you select the Select Date and Time item the Set Date and Time Menu appears Figure 58 Set Date and Time Menu ...

Page 134: ...ed as desired selecting this choice will allow you to save the current settings as the baseline for all new patients The settings that are saved include all of those listed in the Parameter Settings and Waveform Settings tables found in the PPM3 Monitor Settings chapter WARNING A potential hazard can exist if the department default alarm settings are not consistent among all the Nightingale PPM3 m...

Page 135: ...l 1 Press the NBP INTERVAL key to display the Setup NBP Interval menu 2 Select the NBP Interval item by pressing the control knob 3 Scroll the control knob to the desired NIBP Interval Off 2m 3m 5m 10m 15m 30m and 60 minutes and press to select it 4 Press OK button or the MAIN SCREEN key to enter apply that change or press Cancel to cancel the changes Selecting OK with an interval chosen prompts t...

Page 136: ... measurement will automatically be initiated at the next interval To fully disable NBP Interval Mode you must re enter the Setup NBP Interval menu and change the Interval to Off The NBP Interval setting is remembered after a Standby or a power cycle with the same patient However the PPM3 does not automatically initiate NBP Interval Mode measurements after a Standby or a power cycle until the NBP S...

Page 137: ... Key If you press the TRENDS key the Nightingale PPM3 brings up the Trends display See the Viewing Trends chapter for details regarding trends 11 2 6 MAIN SCREEN Key If you press the MAIN SCREEN key the Nightingale PPM3 goes back to the Main Screen Note If a menu is on display when you press the MAIN SCREEN key the PPM3 interprets this as if you had first selected the OK button on the menu Any set...

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Page 139: ... are connected they use the same alarm monitoring settings If a setting is changed at either the PPM3 or the MPC then the setting is updated at both the PPM3 and the MPC This is also true for alarm silencing For example if you silence an alarm at the PPM3 by pressing the ALARM SILENCE key on the front panel keypad it is also silenced at the MPC When the PPM3 and MPC are initially connected there i...

Page 140: ...cal condition e g lead off 12 1 2 Visual Alarm Colors If you see a And It represents Red background parameter box and message area Flashing color twice per second A high grade alarm is currently active and has not been acknowledged Solid color with alarm silence symbol to the left of the message area A high grade alarm is currently active but has already been silenced Yellow background parameter b...

Page 141: ... grade 12 1 3 How to Silence Alarms Action may be taken to silence alarms in one of the following two ways Pressing the ALARM SILENCE key on the front panel Changing the parameter alarm limits such that the current value is no longer out of limits if the alarm was a limit violation alarm If after pressing ALARM SILENCE the alarm condition is still true the tone will cease the flashing backgrounds ...

Page 142: ...istent The lethal Asystole and Ventricular Fibrillation alarms are both persistent and latching What is meant by latching is that they require acknowledgment So if a patient goes into an asystole or ventricular fibrillation condition and then returns to a normal sinus rhythm within the HR alarm limits the HR Asystole or HR Ventricular Fibrillation alarms will continue to annunciate until they are ...

Page 143: ...en this menu item is selected all alarms are disabled for the Alarm Pause Time as configured in the Setup Alarms menu under the Setup Administration menu When the alarm pause time expires alarm monitoring is restored for each parameter based on the Alarms On menu setting for the parameter You can restore alarm monitoring before the alarm pause timer expires by selecting the Alarm Resume item which...

Page 144: ...t 5 seconds IBP Lower Limit 5 seconds The purpose of this feature is to reduce nuisance alarms in which parameter values may go out of limits for a very short time Note Alarm Validation is enabled as a factory default 12 1 7 Alarm Handling at Start up When the PPM3 is initially powered up or brought out of standby alarms will not be annunciated for a given parameter until the lead set or probe has...

Page 145: ...Manually generated reports via the PPM3 s print key are also stored while in Transport Mode and are counted as part of the 10 reports See the MPC User s Guide discussion on the Alarm Log for more details on alarm reports 12 1 9 Audible Alarm Tones While Connected to the MPC When the PPM3 is connected to the MPC central station it can be configured to sound an alarm tone for high grade alarms only ...

Page 146: ...When you silence the alarm both the main speaker and the second speaker if it was sounding are silenced The amount of time delay between when the main speaker starts sounding and when the second speaker starts sounding can be set anywhere between 0 to 180 seconds via the Setup Alarms menu under the Setup Administration menu Since the second speaker has a slightly different sound than the main spea...

Page 147: ...ue applies only to physiological parameters Alarm grade as defined earlier in this chapter Message the text of a message displayed in the message area when the condition is true Annunciation type as defined earlier in this chapter Note The delay between alarm annunciation on the PPM3 and remote annunciation on the MPC central station should be no more than 1 sec General Monitor Conditions Conditio...

Page 148: ...tole Persistent HR Ventricular Fibrillation VF High HR ventricular fibrillation Persistent HR Lead off after startup standby Blank None None Persistent HR Lead off after leads applied Blank Low HR lead off One Time HR Artifact Low HR artifact Persistent RR Conditions Condition Display Value Alarm Grade Message Annunciation Type RR within limits NUM None None None RR LL NUM Medium RR LL Persistent ...

Page 149: ...Low SpO2 artifact Persistent PR Conditions Note When PR is sourced from SpO2 the Pulse Rate is labeled in cyan as HR SpO2 in the HR parameter box When PR is sourced from an ART labeled IBP the PR is labeled in red as HR ART PR alarm conditions annunciate as HR alarms Condition Display Value Alarm Grade Message Annunciation Type PR within limits NUM None None None PR LL NUM Medium HR LL Persistent ...

Page 150: ...Medium NBP blocked hose check patient One Time NBP Measurement Time out 2 minutes Low NBP measurement time exceeded One Time NBP Pump or Valve Failure or NBP Safety Timer Expired or Other H W related problem Medium NBP problem detected One Time NBP Bad Profile Shape Low NBP cannot measure One Time CO2 Conditions Condition Display Value Alarm Grade Message Annunciation Type ETCO2 within limits Numb...

Page 151: ...rong gas Alert Calibration failed occlusion during known gas sampling N A Alert CO2 cal failed Alert Calibration failed FilterLine unplugged during calibration N A Alert CO2 cal failed Alert IBP P1 and P2 Conditions Note P2 has the same conditions as P1 Substitute P1 with P2 as required in the following table Condition Display Value Alarm Grade Message Annunciation Type Systolic pressure within li...

Page 152: ...e Alert Zero failed out of range N A Alert P1 unable to zero out of range Alert Calibration required Blank None P1 needs calibration Persistent Calibration required and 60 seconds has expired Low P1 needs calibration Persistent Calibration in progress Blank None P1 calibrating Persistent Calibration failed pulsatile waveform N A Alert P1 unable to calibrate unstable Alert Calibration failed bad ca...

Page 153: ...ppropriate physiological monitoring chapter e g ECG Monitoring for possible causes and suggested actions MPC connection lost Check to make sure that the Network Cable is still securely connected to the PPM3 and to the wall plate marked Nightingale Monitoring System Talk to the MPC operator and check to make sure that the MPC is still operating normally If none of these steps is successful contact ...

Page 154: ...pO2 sensor to your index finger and wait for the monitor to display a SpO2 parameter value Unplug the sensor from the PPM3 After 10 seconds the PPM3 should sound a low grade alarm tone flash the SpO2 parameter box and display the message SpO2 unplugged If the PPM3 is being monitored at the MPC then disconnect the PPM3 from the communications wall outlet After 30 seconds the PPM3 should sound a low...

Page 155: ...twork Connector labeled as on the right side of the PPM3 Then plug the other end of the Network Cable into the wall plate connector marked Nightingale Monitoring System When this connection is made and the PPM3 is powered on the MPC and PPM3 will start to communicate with each other If a patient is already admitted at the PPM3 the MPC will start monitoring that patient even if a different patient ...

Page 156: ...led if it was enabled at either the PPM3 or MPC If no patient is admitted at the PPM3 when the connection is made then the PPM3 will use the MPC s settings without modification Some settings are not controllable at the PPM3 when the PPM3 is connected to the MPC These include settings that have a system wide impact at the MPC e g the temperature units of measure alarm suspend time out values These ...

Page 157: ...uration SpO2 End tidal CO2 ETCO2 Fractional inspired CO2 FICO2 Integrated Pulmonary Index IPI Temperature T1 Invasive Blood Pressure P1 s d m and P2 s d m If a HR value is being sourced from ECG the trends table will show a HR column labeled in green If PR is being sourced from SpO2 there will be a PR column labeled in cyan If PR is being sourced from an ART labeled IBP there will be a PR column l...

Page 158: ...t Recorder is configured with your PPM3 see the Strip Chart Recorder Option chapter If your PPM3 is connected to the MPC this report will print out immediately on the printer configured with the MPC Otherwise the data will be stored internally and will upload and print automatically the next time the PPM3 is connected to the MPC Using the up and down arrows on the Trends menu you can scroll backwa...

Page 159: ...ightingale PPM3 User s Guide 14 3 Viewing Trends The Clear menu item will cause all the trends data to be deleted Before this happens you will be prompted with the following confirmation Figure 63 Clear Trends Menu ...

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Page 161: ...the PPM3 will present you with the various Standby Mode options Figure 64 Standby Menu Select the Enter Standby Mode menu item if you wish to temporarily suspend all monitoring for this patient say when the patient is being bathed This will place both the PPM3 and the MPC in Standby Mode for this patient In addition the PPM3 will display the Standby Mode Display ...

Page 162: ...Standby Mode When a key is pressed the previous patient must be confirmed If you select No that patient will be discharged and a new patient will be admitted Navigate to the Setup Patient Information Menu to enter information for the new patient Figure 66 Wakeup From Standby Mode ...

Page 163: ...ll be suspended at the MPC for this patient when the Transport Patient menu item is selected When the PPM3 is reconnected to the MPC the MPC will automatically exit Transport Mode and resume monitoring Select the Discharge Patient menu item if you are finished monitoring this patient This will de assign the patient from both the PPM3 and MPC although the patient s trend data will still be archived...

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Page 165: ...east 4 hours of normal operation When the PPM3 is operating on battery power a battery icon appears on the PPM3 screen to the right of the time The battery icon is designed to give an approximate sense of how much battery life is remaining Figure 67 Main Screen With Battery Icon When the battery is running out of charge the battery icon starts to blink a Low Battery alarm message is displayed and ...

Page 166: ... hour of battery use it takes about one hour to recharge the battery A fully depleted battery takes about 5 hours to fully recharge The green LED on the back of the PPM3 indicates that the battery is being charged To determine when the battery is full charged disconnect the battery from the wall power and check the battery icon on the PPM3 Main Screen shown above The toggle switch on the back of t...

Page 167: ...art a recording press the Print key When a recording is in progress you can press the Print key to stop it Plug the recorder cable into the connector labeled as on the left side of the PPM3 Press down on the recorder door latch to release the door Remove the old spool and replace with a new roll The paper should come out from under the roll as shown in the photo Figure 68 PPM3 Recorder Connection ...

Page 168: ...ings The Waveform 2 setting controls which waveform is shown in the bottom channel of the strip chart recordings If this setting value is Off or if it is set to ECG2 but only one ECG waveform is selected for display the strip chart recording will have only one waveform The Recording Time setting controls the amount of time represented on strip chart recordings The Recording Delay setting controls ...

Page 169: ...and lead off handling matches that of the displayed waveform The descriptive text above the waveform area describes the top waveform The text below the waveform area describes the bottom waveform or is left blank if only 1 waveform is printed The descriptive text includes the waveform label the waveform scale and the associated parameter value For ECG waveforms the frequency response fixed at moni...

Page 170: ...nd id as well as comments If patient has been admitted the patient s name is printed 17 5 Recorder Messages If the recorder door is open a technical alarm tone sounds and the message Recorder door open is displayed in the bottom display message area If the recorder is out of paper a technical alarm tone sounds and the message Recorder out of paper is displayed in the bottom display message area Wh...

Page 171: ...it does not start up No power to outlet Verify that the power outlet is working Verify that the green power LED on the PPM3 front panel is illuminated The PPM3 Power Supply is not working Verify that the green charging LED on the PPM3 rear panel is illuminated If possible try using a different PPM3 Power Supply to see if that is the problem The PPM3 is powered off Set the power switch to the On po...

Page 172: ...o request a repair or replacement The PPM3 knob is not working right Knob failure Stop using the PPM3 contact Zoe Medical Technical Support to request a repair or replacement The PPM3 display is not working right Display failure Stop using the PPM3 contact Zoe Medical Technical Support to request a repair or replacement The PPM3 is not working right and displays an error message Operating system f...

Page 173: ...articular PPM3 device Patient Data Settings Setting name Default value Possible values Patient Last Name BLANK any text string 39 characters maximum Patient Middle Initial BLANK any text string 1 characters maximum Patient First Name BLANK any text string 39 characters maximum Patient ID BLANK any text string 39 characters maximum but may not include the following characters since they are not leg...

Page 174: ...gnostic 0 05 40 Hz RR Lower Alarm Limit 5 bpm 10 bpm 5 to 149 bpm Off RR Upper Alarm Limit 20 bpm 45 bpm 6 to 150 bpm Off RR Alarms On Yes Yes No RR Print on Alarm No Yes No ETCO2 Lower Alarm Limit 35 mmHg 0 to 145 mmHg Off ETCO2 Upper Alarm Limit 45 mmHg 5 to 150 mmHg Off ETCO2 Alarms On Yes Yes No ETCO2 Print on Alarm No Yes No FICO2 Upper Alarm Limit 2 mmHg 0 to 98 mmHg Off FICO2 Alarms On Yes ...

Page 175: ...Hg 9 to 250 mmHg Off P1s Alarms On No Yes No P1s Print on Alarm No Yes No P1m Lower Alarm Limit 75 mmHg 10 to 229 mmHg Off P1m Upper Alarm Limit 110 mmHg 9 to 230 mmHg Off P1m Alarms On No Yes No P1m Print on Alarm No Yes No P1d Lower Alarm Limit 55 mmHg 10 to 209 mmHg Off P1d Upper Alarm Limit 100 mmHg 9 to 210 mmHg Off P1d Alarms On No Yes No P1d Print on Alarm No Yes No P1 Label P1 P1 ART PA CV...

Page 176: ...f TEMP Upper Alarm Limit Note Depends On User Setting For TEMP Units 39 0 C 102 0 F 32 1 to 42 0 degrees C Off 89 7 to 107 6 degrees F Off TEMP Alarms On No Yes No TEMP Print on Alarm No Yes No NBPs Lower Alarm Limit 90 mmHg 30 to 249 mmHg Off NBPs Upper Alarm Limit 180 mmHg 145 mmHg 31 to 250 mmHg Off NBPs Alarms On No Yes No NBPs Print on Alarm No Yes No NBPm Lower Alarm Limit 75 mmHg 20 to 229 ...

Page 177: ...10 mm mV 2 5 5 10 15 mm mv ECG AVL Waveform Size 10 mm mV 2 5 5 10 15 mm mv ECG AVR Waveform Size 10 mm mV 2 5 5 10 15 mm mv ECG AVF Waveform Size 10 mm mV 2 5 5 10 15 mm mv CO2 Waveform Size 0 to 40 mmHg 0 to 20 0 to 40 0 to 60 0 to 80 mmHg P1 Waveform Size 0 to 200 mmHg 10 to 20 10 to 60 0 to 150 0 to 200 0 to 250 0 to 300 mmHg P2 Waveform Size 0 to 200 mmHg 10 to 20 10 to 60 0 to 150 0 to 200 0...

Page 178: ... Only Bedside Only Central Only Bedside and Central Set Date Time Year 1980 3000 Set Date Time Month 1 12 Set Date Time Day 1 31 depending on month and leap year status Set Date Time Hour 0 23 Set Date Time Minute 0 59 Simulated Data Mode Off On Off Language English English Notch Filter 60 Hz 60 Hz 50 Hz Off NIBP Cal Mode Off On Off Monitor ID BLANK Any text string 23 characters maximum Serial Num...

Page 179: ... 3 Lead Set US 1 5 meter Snap On 421 0038 ECG 3 Lead Set US 3 0 meter Snap On 421 0110 ECG 5 Lead Set US 1 5 meter Snap On 421 0032 ECG 5 Lead Set US 3 0 meter Snap On SpO2 Monitoring Accessories 180 3014 SpO2 Sensor Reusable 180 3008 SpO2 Extender Cable 4 foot 180 3007 SpO2 Extender Cable 8 foot NBP Monitoring Accessories 180 1004 NBP Hose 180 1022 NBP Cuff Adult 26 35 cm 180 1023 NBP Cuff Large ...

Page 180: ...ssories 180 8008 Table Stand tilted 180 8008 1 TABLE STAND FOR PPM3 180 8008 2 TABLE STAND FOR PPM2 PPM3 w Recorder 180 8016 Pole Mount C Clamp Mount 180 8017 Roll Stand Kit 180 8014 Wall Mount Channel and Arm Kit Requires PPM3 Pole Mount Power Supply 725 0037 PPM3 Power Supply 180 6001 Power Cord US 10 ft 180 1055 Lithium Ion Battery Strip Chart Recorder Option 180 0100 50mm Strip Chart Recorder ...

Page 181: ...d or soft bristled brushes Protective gloves and eyewear Procedure 1 Disconnect the unit from the wall outlet 2 Put on gloves and protective eyewear 3 Prepare the enzymatic detergent according to the manufacturer s instructions and also the disinfectant solution in separate containers 4 Apply detergent to product using a soft cloth If material is dried on allow to sit for 1 minute 5 Wipe smooth su...

Page 182: ...idestream CO2 Analyzer Materials Cloth moistened with 70 max ethanol or isopropyl alcohol Procedure Remove probe from patient Keep sampling line connected while cleaning to prevent liquids and dust from entering the analyzer via the LEGI connector Wipe off with cloth Allow analyzer to dry before placing it on a patient CAUTION Always disconnect the PPM3 from AC mains before cleaning CAUTION Do not...

Page 183: ...acy and damage the monitor CAUTION Microstream ETCO2 sampling lines are designed for single patient use and are not to be reprocessed Do not attempt to clean disinfect sterilize or flush any part of the sampling line as this can cause damage to the monitor CAUTION Accessories that fall on the floor should be inspected for contamination and proper functionality If contamination is observed then thi...

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Page 185: ...05 Series Oridion Microstream calibration kit from Air Liquide Scott Medical Part Number T4653ORFCD including a canister of 5 CO2 21 O2 with the balance N2 along with a T piece connection and a calibration Filterline 22 1 PPM3 Functional Tests PPM3 Function Procedure Mechanical Integrity Check for cracks abrasive edges and other signs of damage Knob Verify menu navigation functionality by turning ...

Page 186: ...et and this will affect the validity of the calibration check NOTE The following are required to perform this test NIBP simulator or sphygmomanometer along with a Y adapter and a hand inflation bulb Pressure Accuracy Test Via the Service settings put the NIBP in to calibration mode Set the pressure to 25 mmHg and 225 mmHg respectively and verify that the pressure values reported by the PPM3 patien...

Page 187: ... cal gas can be applied to the PPM3 patient monitor in pulses that simulate patient breaths 1 Connect the PPM3 to a calibration gas canister 5 CO2 21 02 Balance N2 2 Pulse the calibration gas actuator holding it depressed for 10 seconds and released for 10 seconds 3 BPM This will allow enough time for the CO2 values to stabilize 3 Verify that the FiCO2 value is 0 2 mmHg and that the ETCO2 value is...

Page 188: ... displayed 2 mmHg Temperature None self checking Leakage Current Connect to Safety Analyzer WARNING FOLLOW SAFETY INSTRUCTIONS AS INDICATED IN THE MANUAL FOR THE ANALYZER Verify Patient Lead Leakage to ground 10 uA Verify Patient Lead Leakage inter lead 10 uA Verify Patient Lead Leakage mains applied to leads 50 uA Verify Leakage to ground normal 500 uA Verify Leakage to ground reversed polarity 1...

Page 189: ...trained technician NOTE Ensure that the calibration gas and regulator are functioning properly before calibration NOTE Calibration of the CO2 module will require a calibrated gas mixture of 5 CO2 21 O2 with the balance N2 The calibration kit available from Air Liquide Scott Medical Part Number T4653ORFCD contains a canister of the above gas mixture a T piece connector and a Calibration Filterline ...

Page 190: ...his screen 3 Await P1 Calibration OK message or similar if the interface is labeled something other than P1 4 Repeat for interface P2 NBP Non Invasive Blood Pressure The NIBP interface does not require calibration during normal clinical operation The accuracy of the NIBP pressure sensor and overall functionality of the NIBP interface can be verified as detailed in the Nightingale PPM3 Functional T...

Page 191: ...ng on the strap that is attached to the battery 4 Insert the new battery taking care to face the label side of the battery towards the front of the device The battery will not fully insert otherwise 5 Reattach the battery access door WARNING APPROVED BATTERIES Only use batteries that are listed in the Accessories chapter 22 4 Storage Storage Temperature 4 to 140 F 20 to 60 C Storage Humidity 15 to...

Page 192: ...pO2 Sensors Cables 90 days ECG Cables 90 days Printers 1 year Other Accessories Out of box failure only Zoe Medical s sole obligation under this warranty is limited to repairing a product which has been reported to Zoe s Technical Service Center during normal business hours and shipped transportation prepaid Zoe Medical shall not be liable for any damages including but not limited to incidental da...

Page 193: ...en evaluated at Zoe Medical the customer is responsible for the evaluation fee plus the shipping back to the customer Zoe Medical will honor rush repair requests Please inform Customer Support at the time of the RMA request A flat rate fee will be added to the cost of the repair invoice Contact Zoe Medical Customer Support for current flat rate and estimate fees ZOE MEDICAL INCORPORATED PRODUCTS C...

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Page 195: ... s Guide 22 1 Maintenance and Storage 22 6 Password Control To access the Setup Alarms or Setup System menu perform the following steps when presented with the Password menu Set Dial 1 to 49 Set Dial 2 to 48 Set Dial 3 to 46 Select OK ...

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Page 197: ...cturer s recommendations At the end of its useful life the Nightingale PPM3 should be properly disposed of as well In particular the PPM3 contains a lithium coin battery a lithium ion battery and electronic circuit boards which should not be incinerated or exposed to extreme heat See warnings at the start of this manual for further precautions Contact your local waste disposal agency for guidance ...

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Page 199: ...SO 80601 2 30 2009 Non Invasive Blood Pressure IEC 60601 2 34 2011 Invasive Blood Pressure ISO 80601 2 55 2011 CO2 Respiratory Gas Monitoring ISO 80601 2 56 2009 Temperature ISO 80601 2 61 2011 SpO2 IEC 62366 2007 Usability IEC 62304 2006 Software Patient Risk Current IEC 60601 1 Electromedical Apparatus with Isolated Patient Connection Meets the following limits Enclosure Risk Current 100 μA Pati...

Page 200: ...n Directive 2002 96 on Waste Electrical and Electronic Equipment WEEE requires separate handling for waste disposal according to national requirements IPX1 Indicates device has been tested for safety from vertically dripping water specifically it indicates DRIP PROOF a higher than ordinary level of protection from drips leaks and spills External AC DC power supply only use Zoe Medical P N 725 0037...

Page 201: ...rging Time 4 hours minimum Charging Time 5 hours Charging Method Battery is charged while monitor is connected to AC main Environmental Cooling Convection no fan Operating Temperature 32 to 104 F 0 to 40 C Storage Temperature 4 to 140 F 20 to 60 C Operating Humidity 15 to 90 non condensing Storage Humidity 15 to 95 non condensing Operating Altitude 0 to 15 000 0 to 4572 m Storage Altitude 0 to 40 ...

Page 202: ...ex B1 10 sec 5 sec typical IEC 60601 2 27 ECG Complex B2 10 sec 9 sec typical Notch Filter Frequency 50Hz 60 Hz Off Filter Bandwidth Monitor Mode 0 67 Hz to 40 Hz 3 dB Diagnostic Mode 0 05 to 40 Hz 3 dB Dynamic Range AC 5 mV per IEC 60601 2 27 Dynamic Range DC 300 mV per IEC 60601 2 27 Electrode Impedance 2 5 MOhm per IEC 60601 2 27 Defibrillation Protection Complies with IEC 60601 2 27 Pacer Puls...

Page 203: ... Pulse Oximetry Method Absorption Spectrophotometric dual wavelength Functional oxygen saturation of arterial hemoglobin Input Connector 9 pin connector SpO2 PR Resolution SpO2 1 O2 PR 1 bpm beat per minute Measurement Range SpO2 20 to 100 PR 30 to 240 bpm Measurement Accuracy SpO2 from 70 to 100 2 O2 70 unspecified PR 3 bpm Measurement Test Method Comparison versus co oximeter per ISO 80601 2 61 ...

Page 204: ...reater Update Interval Upon measurement completion Measurement Time 30 seconds typical 135 seconds maximum Initial Cuff Pressure 160 mmHg user selectable Repeated Cuff Pressure Previous systolic 40 mmHg Static Cuff Pressure Accuracy 3 mmHg Overpressure Cutoff 290 3 mmHg normal means 300 10 mmHg back up Measurement Modes Single Measurement or Auto Interval Measurement Auto Measurement Settings Off ...

Page 205: ...pm 1 bpm 71 to 120 bpm 2 bpm ETCO2 FICO2 and Respiration accuracy tested according to ISO21647 using a mixture of gases 5 CO2 21 O2 N2 balance supplied via function generator and breath simulator application Respiration rates from 10 60 bpm for adults pediatrics as measured in 10 bpm discrete steps were tested for 1 minute before moving forward to the next value and at the end of this one minute p...

Page 206: ...15 vol 0 2 vol 2 of reading 15 to 25 vol unspecified CO2 Resolution 1 mmHg RRc Resp Rate Measurement Range 0 to 150 1 bpm RRc Resolution 1 bpm Barometric Pressure Range 525 to 1200 hPa Barometric Pressure Compensation Automatic Report Interval Per breath Flow Rate 50 10 sml min Warm up Time Required to Meet Accuracy Specifications 10 seconds concentrations reported and full accuracy Total System R...

Page 207: ...e Compensation Automatic Report Interval Per breath Warm up Time Required to Meet Accuracy Specifications 10 seconds concentrations reported and full accuracy Total System Response Time 1 second Drift of Measurement Accuracy Complies with EN ISO 21647 2004 standard Measurement Accuracy for Gas Mixture Complies with EN ISO 21647 2004 standard Measurement Accuracy in the Presence of Interfering Gase...

Page 208: ...ate Rate Every 3 seconds Temperature Compatibility YSI 400 series probes Measurement Mode Direct as defined in ISO 80601 2 56 Input Connector 2 pin connector Display Units F and C user selectable Measurement Resolution 0 1 F 0 1 C Measurement Range 41 0 to 122 0 F 5 0 to 50 0 C Measurement Accuracy 0 2 F 0 1 C plus probe tolerance Transient Response Within 30 seconds from 25 to 27 C ...

Page 209: ... PPM3 Guidance and manufacturer s declaration electromagnetic emissions The Nightingale PPM3 is intended for use in the electromagnetic environment specified below The user of the Nightingale PPM3 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Nightingale PPM3 uses RF energy only for its internal...

Page 210: ...put lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential Mode 2 kV common mode 1 kV differential Mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power sup...

Page 211: ...s 5 UT 95 dip in UT for 5 s Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note UT is the AC mains voltage prior to application of the test level ...

Page 212: ...no closer to any part of the Nightingale PPM3 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 d 1 2 80 MHz to 800 MHz d 2 3 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recom...

Page 213: ...ters an electromagnetic site survey should be considered If the measured field strength in the location in which the Nightingale PPM3 is used exceeds the applicable RF compliance level above the Nightingale PPM3 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the PPM3 monitor b Over the freque...

Page 214: ...m output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 5 GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation ap...

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