Home

Welch Allyn Medical Diagnostic Equipment Computer Monitor 406 User's Manual

1. Characteristic Specification Connector Hypertronics D01 latching connector Selectable Leads 5 Lead Cable Monitored II Ill V Derived aVp aV aVe 3 Lead Application using 3 lead ECG cable or 5 lead ECG cable with detachable lead wires only RA LA LL electrodes connected Monitored Il Lead Fault Indicator Displayed chest icon with flashing indicator for each electrode ECG Size sensitivity 0 2 0 5 1 2 4 and 8 mV cm Display Sweep Speed 25 mm sec Bandwidth Local display 0 5 to 94 Hz independent of patient mode To Acuity Central Station 0 05 to 94 Hz independent of patient mode Sample Rate 364 Hz 182 Hz with turning point decimation to Acuity Central Station Input Protection Electrosurgery and defibrillator protected when used with ECG cables specified in the Welch Allyn Products and Accessories booklet 810 0409 XX Electrosurgery interference suppression Included on all vectors Lead Fail Sense Current 70 nA dc typical for active leads 140 280 nA dc typical for reference electrode depending on number of electrodes attached Tall T wave Rejection Meets AAMI USA EC13 1992 section 3 1 2 1 c up through 1 2 mV 54 Chapter 6 Reference Welch Allyn Micropaq Monitor Characteristic Specification Common Mode Rejection FILTER function OFF FILTER function ON 1 mV p p RTI for 10V rms 50 60 Hz into unbalanced input 30 uV p p
2. Flashing numerics indicate patient alarm Press to silence the alarm tone 1 Check the patient and provide appropriate care 2 To silence the alarm tone at the monitor and the Acuity Central Station for 90 seconds press v While the alarm tone is silenced visual alarm indications continue and the red alarm indicator on the monitor changes from a flashing display to a continuous display If the alarm condition still exists after 90 seconds the alarm tone resumes Note Ifyou silence an alarm at the monitor and another patient alarm or an equipment alert occurs during the silence period the tone resumes at the monitor At Acuity only life threatening arrhythmia alarms interrupt the silence period If you suspend an alarm at Acuity only life threatening arrhythmia alarms interrupt the silence period at the monitor and Acuity To access the Main Menu during silencing press we Directions for Use Chapter 3 Alarms amp alerts 37 3 To reset the alarm tone at the monitor and Acuity before the 90 seconds has elapsed press 44 at the monitor or press Resume at the Acuity Central Station 4 After caring for the patient make sure that the appropriate alarm limits are set and that alarms are on Customize patient alarm limits at the monitor A WARNING If the patient s name has not yet been assigned to the monitor do not adjust any alarm limits until after the patient name and ID are confirmed at Acuit
3. 68 Chapter 7 Compliance Welch Allyn Micropaq Monitor Monitor Guidance and Manufacturer s Declaration Electromagnetic Immunity The Model 4XX Series Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the monitor should assure that it is used in such an environment Immunity Test IEC 60601 Test Compliance Electromagnetic Environment Guidance Level Level Portable and mobile RF communications equipment should be used no closer to any part of the Model 4XX Series Monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Conducted RF 3 Vims 3 Vins d 1 2 JP IEC 61000 4 6 150 kHz to 80 MHz 2Hz AM Radiated RF 3 V m 3 V m d 1 2 JP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz 2uz AM d 2 3 JP 800MHzto2 5 GHz where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and d is the recommended separation distance in meters Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol t2 Note 1 At 80 MHz and 800 MHz th e higher frequency range applies Note 2 These guidelines may not
4. If the monitor is moved out of range or loses communication with the FlexNet network and Acuity it continues to monitor the patient and display patient data While not communicating with Acuity the monitor continues to generate local patient alarms or alert messages Patient data is not stored and Acuity does not perform waveform analysis or generate arrhythmia messages while the monitor is not communicating with Acuity When the monitor is returned to within range of the FlexNet network it automatically reconnects to Acuity Directions for Use Chapter 1 General information Monitor features Controls and connectors ENS Connector DS ci S ECG Connector Visual Alarm Indicator gt iu Crystal Display Select Key and Silence Patient Alarm Equipment Alert Key Scroll Up Key and Reset Patient Alarm Tone Key Scroll Down Key and Main Menu Key Sp02 p c connector clip model 408 or cover model 406 Battery pack latch un Battery E Back 9 10 Chapter 1 General information Welch Allyn Micropaq Monitor Visual alarm indicator Green Flashes slowly during normal operation Red Flashes during patient alarm remains on continuously when alarms are silenced or suspended Yellow Flashes during an equipment alert or while not connected to the network Remains on continuously if the operator suspends an alert at Acuity for 90 seconds or acknowledges dismisses a low battery
5. Swedish H rmed intygar Welch Allyn att denna RLAN device st r verensst mmelse med de v sentliga egenskapskrav och vriga relevanta best mmelser som framg r av direktiv 1999 5 EG Electromagnetic compatibility Special precautions concerning electromagnetic compatibility EMC must be taken for all medical electrical equipment This device complies with IEC EN 60601 1 2 2001 All medical electrical equipment must be installed and put into service in accordance with the EMC information provided in this document and the Micropaq Monitor Directions For Use Portable and mobile RF communications equipment can affect the behavior of medical electrical equipment The monitors and battery charger comply with all applicable and required standards for electromagnetic interference It does not normally affect nearby equipment and devices It is not normally affected by nearby equipment and devices It is safe to operate the monitor in the presence of high frequency surgical equipment However it is good practice to avoid using the monitor in extremely close proximity to other equipment 66 Chapter 7 Compliance Welch Allyn Micropaq Monitor Monitor Monitor Guidance and Manufacturer s Declaration Electromagnetic Emissions The Model 4XX Series Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the monitor should assure that it is used in such an enviro
6. recommended below according to the maximum output power of the communications equipment Rated Maximum Output Power of Separation Distance m According to Frequency of Transmitter Transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 JP d 1 2 JP d 23 JP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 23 10 3 8 3 8 73 100 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 applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts w according to the transmitter manufacturer NOTE 1 NOTE 2 and reflection from structures objects and people At 80 MHz and 800 MHz the separation distance for the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption 70 Chapter 7 Compliance Battery charger for the monitor Welch Allyn Micropaq Monitor Monitor Battery Charger Only Guidance and Manufacturer s Declaration Electromagnetic Emissions The Battery Charger for the Model 4XX Series Mon itor is intended for use in the electromagnetic environment specified below The customer or the user of the battery charger should assure that it is used in such an environment Emissions test Compliance Electromagnetic Environment Gui
7. 3 Press wg to highlight END TELE then press v 4 When the monitor displays the message SAFE TO REMOVE BATTERY remove the battery If the battery is not removed within 30 seconds the monitor will automatically try to reconnect to the network 5 Disconnect the leads and sensors from the patient Note If you do not use END TELE to disconnect from the network as described above the Acuity Central Station generates a DROPOUT equipment alert at Acuity If you want to monitor this same patient at a later time you will need to reselect the patient name from the monitor or confirm the patient ID at Acuity Directions for Use Chapter 2 Monitoring 31 Reconnect a recently monitored patient 1 Insert a battery into the monitor to turn on the monitor Confirm that after a few seconds the monitor Power Up Screen is replaced by the initial monitoring screen 2 The monitor will then present a series of menus and messages requesting you to provide information about the connection and patient The actual screens presented depend on how long the patient has been disconnected Provide the information as requested This may include Note Select an Acuity unit Select a patient from the patient list Select a patient room from the room list If you do not select the patient name or room while connecting the patient you will need to do that later at the Acuity Central Station See Monitor patient at Acuity on page 41 for more informa
8. Liechtenstein Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Slovenia Spain Sweden Switzerland U K a This device may be not be operated outdoors when using the bands 5150 to 5350 MHz Channels 36 40 44 48 52 56 50 64 b This device must be used with Access Points that have employed and activated a radar detection feature required for European Community operation in the 5GHz bands This device will operate under the control of the Access Point in order to avoid operating on a channel occupied by any radar system in the area The presence of nearby radar operation may result in temporary interruption in communications of this device The Access Point s radar detection feature will automatically restart operation on a channel free of radar You may consult with the local technical support staff responsible for the wireless network to ensure the Access Point device s are properly configured for European Community operation c To remain in conformance with European spectrum usage laws for Wireless LAN operation the above 5 GHz channel limitations apply The user should check the current channel of operation If operation is occurring outside of the allowable frequencies as listed above the user must cease operating the device at that location and consult the local technical support staff responsible for the wireless network d In Italy the end user must apply for a license from the national spectrum auth
9. 2 If possible determine what caused the problem and correct it Note After you press Y to acknowledge or silence some types of alerts the yellow LED remains on either flashing or steady yellow until you correct the problem For low battery alerts and no Acuity connection alerts specific icons also flash For a list of possible messages and suggested responses see Alert messages and display information on page 40 40 Chapter 3 Alarms amp alerts Welch Allyn Micropaq Monitor Alert messages and display information Message and Display Information Possible Cause s and Suggested Response LOW BATTERY The monitor will shut down within approximately 30 minutes or less due to a low battery e Replace the battery as soon as possible VERY LOW BATTERY The monitor will shut down within approximately 5 minutes or less due to a low battery e Replace the battery as soon as possible BATTERY TOO LOW SHUT DOWN IN PROGRESS The battery is so low the monitor has to shut down operation e Replace the battery immediately ACUITY CONNECTION LOST The monitor is not connected to the network e Press x to acknowledge and silence the tone and cancel the message While disconnected from the network the off network icon and the yellow LED continue to flash NOTE The monitor will continue to attempt to reconnect until it is successful EXCESSIVE ECG OFFSET REPLACE ELECTRODES The monitor detects poor ECG
10. If you want to discontinue monitoring a patient and reconnect the monitor to a new patient follow these steps 1 2 Press ww to display the Main Menu Press ww again to highlight ACUITY and press Y to display the Acuity Menu screen Press wr to highlight NEW PATIENT then press X John Smith HR Sp 2 BPH 80 9 a 37 END TELE ACUITY NEW ROOM MENU TRANSFER EH PATIENT T Select a New Patient The monitor then presents a series of menus and messages requesting you to provide depend information about the connection and patient The actual screens presented on how the Acuity System is configured Provide the information as requested This may include Select an Acuity unit Select a patient from the patient list After you select a new patient all monitor operating settings are reset to the Acuity System default powerup settings Select a patient room from the room list If you do not select the patient name or room while connecting the patient you will need to page 41 do that later at the Acuity Central Station See Monitor patient at Acuity on for more information To perform ECG monitoring see Perform ECG monitoring on page 21 To perform SpO monitoring see Perform SpO2 monitoring on page 26 35 3 Alarms amp alerts About alarms and alerts Alarms provide a warning about a patient condition such as a vital sign limit violation Alerts provide a
11. RTI for 10V rms 50 60 Hz into unbalanced input Input Impedance 22 5 M differential 60 Hz Input Range ac 10 mV peak to peak local display 10 mV peak to peak Acuity Central Station Input Range dc Up to 500 mV System Noise 030 uV peak to peak RTI ORS Detector Adult or Pediatric Amplitude Range 0 22 to 5 0 mV RTI Adult Width Range Duration 70 to 120 msec Pediatric Width Range Duration 40 to 120 msec Heart Rate Range Alarm Limits 25 to 350 beats per minute measurement 25 to 300 beats per minute display 25 to 245 beats per minute lower 30 to 250 beats per minute upper Heart Rate Meter Response Time Responds to change in heart rate within 5 to 9 seconds depending on physiological waveform As measured per AAMI standard EC13 1992 clause 4 1 2 1 f including 3 1 2 1 parts f and g waveforms Includes 1 second readout update interval HR Display Update Interval at monitor 1 second HR Accuracy 3 beats per minute or 3 whichever is greater Heart Rate Response to ineffectively paced ORS pattern Indicates rate of 30 to 46 during AAMI EC13 1992 part 3 1 4 1 part f and g tests NOTE AAMI Test 4 1 4 part f and g Accuracy is affected i e rate increases when ORS and pacer spikes are nearly simultaneous as occasionally is the case during this AAMI test Heart Rate Averaging Method Heart rate 60 latest average interval
12. The customer or the user of the monitor should assure that it is used in s uch an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete ESD 8 kV air 8 kV air or ceramic tile If floors are IEC 61000 4 2 covered with synthetic material the relative humidity should be at least 3096 Electrical fast transient 2 kV for power supply No connection to mains Since there is no connection to the burst lines battery operated No mains there is no requirement for IEC 61000 4 4 1 kV for input output other cables requiring mains quality lines EFT Burst testing Surge 1 kV differential mode No connection to mains IEC 61000 4 5 2 kV common mode battery operated Voltage dips short lt 5 U No connection to mains interruptions and voltage gt 95 dip in U4 battery operated variations on power for 0 5 cycle supply input lines 40 U IEC 61000 4 11 60 dip in U for 5 cycles 70 U 30 dip in 4 for 25 cycles lt 5 U gt 95 dip in U for 5 sec Power frequency 50 60 3 A m 3 A m Power frequency magnetic fields Hz magnetic field should be at levels characteristic IEC 61000 4 8 of a typical location in a typical commercial or hospital environment Note Wis the AC mains voltage prior to application of the test level
13. affected by absorption and nd people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcas cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Battery Charger is used exceeds the applicable RF compliance level above the Battery Charger should be observed to verify normal operation If abnormal perf or relocating the Battery Charger ormance is observed additional measures may be necessary such as reorienting b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Directions for Use Chapter 7 Compliance 73 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Battery Charger for the Model 4XX Series Monitor The Battery Charger for the M odel 4XX Series Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Battery Charger can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the communications equipment he Battery Charger as reco
14. alarm limits 18 Toggling between modes 18 Demonstration Mode 17 Disconnection symbol 12 Discontinue monitoring a patient 30 Display Alert messages 40 Artifact interference 22 Blank during sleep mode 12 Indicator symbols 12 Pacemaker signals 12 Sleep mode 12 Specifications 59 Waveform display options 15 DROPOUT alert at Acuity 30 43 E ECG Alarm holdoff delay 35 Electrode application 21 Electrode lead off 23 Lead selection 13 Scale selection 13 Size scale selection 13 Electrode application 21 Electrosurgery warning 4 END TELE 13 30 Environmental specifications 59 Equipment alert Description 38 Messages 40 Errors Error message 6 Error number 6 Ethernet 1 EXCESSIVE ECG OFFSET 40 F FCC Warning RF 5 Federal Communications Commission see FCC FlexNet 1 8 Access points 8 Welch Allyn Micropaq Monitor Automatic reconnection 8 Defined 8 Operation out of range 8 Full Screen waveform display 15 G General cautions 6 General Warnings 4 Green LED 10 H Hazards General cautions 6 General warnings 4 Holdoffs delays for alarms 35 Hyperbaric chamber Warning do not use 4 21 Hypotension and Sp02 27 Hypothermia and Sp02 27 In Service see Demo Mode Inspection 45 Intended Use 1 K Keys Alarm Alert Silence 11 Scroll Up Down 10 Select 11 KEY STUCK 40 L Lead off indication 23 Lead selection 13 LEDs defined 10 List of p
15. apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Model 4XX Series Monitor is used exceeds the applicable RF compliance level above the Model 4XX Series Monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the monitor b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Directions for Use Chapter 7 Compliance 69 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Model 4XX Series Monitor The Model 4XX Series Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances electromagnetic interference by maintaining a uipment transmitters and the monitor as are controlled The customer or the user of the monitor can help preven minimum distance between portable and mobile RF communications eq
16. contact other conductive parts including earth ground at any time WARNING Use only accessories supplied by Welch Allyn or recommended in the Welch Allyn Products and Accessories booklet 810 0409 XX The monitor will only meet the listed specifications when using accessories listed by Welch Allyn Use accessories according to your facility s standards and the manufacturer s recommendations Always refer to the manufacturer s Directions for Use WARNING As with all medical equipment carefully route the patient cabling to reduce the possibility of patient entanglement or strangulation Use the supplied garment clips to secure the cable properly WARNING When positioning the monitor pouch on the patient make sure the straps do not entangle the patient s neck or cause choking Make sure the straps do not restrict the movement of the patient s limbs or create a hazard when walking or moving WARNING If a product has been dropped or severely abused send it to a qualified service person to confirm proper operation WARNING Do not use the pulse oximeter as a replacement or substitute for ECG based arrhythmia analysis Caution Do not autoclave the monitor Autoclave accessories only if the manufacturer s instructions clearly approve it Many accessories can be severely damaged by autoclaving It is possible for the monitor to detect a problem that prevents the monitor from operating properly If this occurs the monitor displays an error mes
17. determines default alarm limits and internal algorithm settings WARNING The monitor may not meet its performance specifications if stored or used outside the specified temperature and humidity ranges WARNING Do not connect more than one patient to a monitor Do not connect more than one monitor to a patient WARNING During defibrillation keep the discharge paddles away from ECG and other electrodes as well as other conductive parts in contact with the patient WARNING Do not operate this product in the presence of flammable anesthetics or other flammable substances in combination with air oxygen enriched environments or nitrous oxide explosion can result WARNING Do not use the monitor in a Magnetic Resonance Imaging MRI suite or a hyperbaric chamber Such use can cause fire or explosion resulting in patient injury and monitor damage Directions for Use A Chapter 1 General information WARNING Magnetic Resonance MR Safety This monitor is designated Not MR Safe as defined in the ACR Guidance for Safe MR Practices 2007 Do not place this monitor in Zones 3 or 4 in MR environments for which Zones have been established and marked in accordance with the Guidance In MR environments for which Zones have not been designated do not place this monitor into a magnetic field with field strength larger than the field strength that your facility permits to exist in areas that are accessible by personnel patients and guests witho
18. erroneous pulse rate readings Be sure to validate the patient data and patient condition before intervention or change in patient care WARNING Interfering Substances Carboxyhemoglobin may erroneously increase readings the level of increase is approximately equal to the amount of carboxyhemoglobin present Methemoglobin may also cause erroneous readings Dyes or any substances containing dyes that change usual arterial pigmentation may cause erroneous readings Directions for Use Chapter 2 Monitoring 27 Attach the SpO sensor to the patient according to the manufacturer s directions for use observing all warnings and cautions Each SpO sensor is designed for application to a specific site on the patient within a certain size range To obtain optimal performance use an appropriate sensor and apply it as described in the sensor s directions for use If excessive ambient light is present cover the sensor site with opaque material to block the light Failure to do so may result in inaccurate measurements Light sources that can affect performance include surgical lights especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps and direct sunlight If NIBP will be monitored while using SpO place the NIBP cuff on a different limb than the SpO sensor to help reduce unnecessary SpO gt alarms For optimal measurements avoid placing the SpO sensor on the same limb as an arterial cath
19. high temperature above 60 C or 140 F Use only the specified monitor battery charger Directions for Use Chapter 6 Reference 61 Eight bay battery charger specifications Characteristic Specification Reorder Number Universal Battery Charger Active C 008 0651 XX Functional Specifications Capacity Eight charging bays able to charge four Lithium lon batteries simultaneously Protection Classifications Duty Cycle Continuous Type of Protection Against Electric Shock Class Protectively Earthed with Double Insulation Degree of Protection Against Harmful Ingress of Water For ordinary indoor locations only Method of Disinfection Not suitable for autoclaving See cleaning instructions on Inspect the monitor batteries battery charger and accessories on page 45 Flammable Anesthetics Not suitable for use with flammable anesthetics Environmental Specifications Operating Temperature 0 to 40 C Shipping and Storage Temperature 20 to 60 C Operating Altitude 2 000 to 15 000 feet 610 to 4 572 m Shipping and Storage Altitude 2 000 to 40 000 feet 610 to 12 192 m Operating Relative Humidity 15 to 9596 noncondensing Shipping Storage Relative Humidity 15 to 9596 noncondensing Shock 30g Vibration 0 0192 Hz from 5 to 500 Hz 30 minutes per axis Electroma
20. of the FCC Rules Operation is subject to the following two conditions e This device may not cause harmful interference e This device must accept any interference received including interference that may cause undesired operation This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy If not installed and used in accordance with the instructions it may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by tuning the equipment off and on the user is encouraged to try and correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the distance between the equipment and the receiver e Connect the equipment to outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help The user may find the following booklet prepared by the Federal Communications Commission helpful The Interference Handbook This booklet is available from the
21. the Council of the European Union on Waste Electronic and Electrical Equipment WEEE If the monitor or battery Li is contaminated this directive does not apply For more specific information see www welchallyn com weee or contact Welch Allyn Customer Service Batteries and accumulators containing certain dangerous substances and bd amp y Recycle monitor batteries Li according to the Directive 91 157 EEC Li Directive 93 86 EEC Labelling of batteries and accumulators containing certain dangerous substances 48 Chapter 5 Maintenance Welch Allyn Micropaq Monitor Change the network name This procedure allows you to change the network name assigned to the monitor as long as the current network name is one of the pre set names available in the monitor Network Name Menu WARNING Changing the monitor network name will cause the monitor to re A start and seek to connect with the FlexNet network corresponding to the new name Do not attempt to change the network name unless you are a qualified biomedical service engineer or technician or a Welch Allyn employee and only change the network name in a non clinical environment To change the network name 1 Press wr to access the Main Menu then repeatedly press yw until SERVICE MENU is highlighted 2 Press x to display the Service Menu screen 3 Pressand hold s and wr then press x to display the Network Name Menu If the current monitor network name is one o
22. upon rate meter alarms All pacemaker patients should be kept under close or constant observation See ECG specifications on page 53 for disclosure of the pacemaker pulse rejection capability of this instrument 22 Chapter 2 Monitoring A Welch Allyn Micropaq Monitor WARNING For patients with a pacemaker position the monitor to maintain a minimum 6 inch distance between the monitor and pacemaker Immediately turn the monitor off and provide appropriate patient care if you have any reason to suspect that the monitor is interfering with the pacemaker The Health Industry Manufacturers Association recommends this minimum 6 inch distance between a hand held wireless radio and a pacemaker which is consistent with the independent research by and recommendations of Wireless Technology Research WARNING High intensity radio frequency RF energy from external sources such as an improperly connected electrosurgical unit can induce heat into electrodes and cables which can cause burns on the patient Reading errors and damage to equipment may also result This hazard can be reduced by 1 avoiding the use of small ECG electrodes 2 selecting ECG electrode attachment points remote from the surgical site and from the electrosurgical return electrode 3 using electrosurgical return electrodes with the largest practical contact area and 4 assuring proper application of the electrosurgical return electrode to the patient WARNING V
23. yellow LED is on continuously the battery may have reached the end of its useful life Refer to the table below for suggested responses Charger LED Battery Charger Battery Status and Possible Response Label LEDs Green LED on Battery is fully charged continuously o 3 Green LED vw Battery is charging flashing A T Green LED 1 Battery is detected and waiting to be charged flashing very a slowly 1 LED off No battery is detected Yellow LED on Something is wrong with the battery or the charger Remove the battery continuously Q a A e If the LED goes off it is probably a battery problem Insert a new battery into the same battery well If the new battery charges correctly then the battery has a problem discard the battery The battery reorder number is 008 0647 XX If the same problem occurs with the new battery the charger may need repair Contact biomedical engineering e fthe LED does not go off when you remove the battery it is probably a charger problem Unplug the charger power cord wait at least 5 seconds then plug in the charger power cord again Insert a new battery into the same battery well If the new battery charges correctly then the battery has a problem discard the battery If the same problem occurs with the new battery the charger may need repair Contact biomedical engineering The charger can accommodate up to eight batteries The charger charges a maximum of four batteries at
24. 02 27 NO ECG CABLE DETECTED 40 NO SP02 SENSOR DETECTED 40 O Operation Default settings 16 Settings 16 Operator maintenance 43 Out of range 8 Monitor a patient out of range 29 OxiMax technology Nellcor 7 P Pacemaker Signal detection display 12 Warning rate meters 4 Warning wireless radio 6 Pacer see Pacemaker Pacer detection 51 Patient Alarms 36 Reassign to a new room 32 Reconnect a recently monitored patient 31 TRANSFER 33 Patient alarms Download defaults from Acuity 21 Patient list 20 Patient preparation for ECG 21 Physical specifications 60 Power specifications 60 Prepare the patient 21 Pulse oximetry see Sp02 R Radio Frequency see RF Reassign Micropaq to new patient 34 Reassign to a new room 32 Recharge a battery 43 78 Index Reconnect a recently monitored patient 31 Reconnection to network 8 Recycling Batteries 47 Monitor 47 Red LED 10 Replace the battery 43 Respond to equipment alert 38 Respond to patient alarms 36 RF warning exposure 5 Room selection 21 Routine maintenance 43 S Scroll Up Down Keys 10 Select Patient 20 Room 21 Select Patient at Central 20 Select Room at Central 21 Select Key 11 Select Room at Central 32 33 Set patient alarms 37 SET technology Masimo 7 Settings operating 51 Shock and Sp02 27 Silence Alarm Alert Key 11 Silence alarms 36 Simulation see Demo Mode Site preparation for ECG 21 Sleep mode displa
25. 999 5 EK Hungarian Alul rott Welch Allyn nyilatkozom hogy a RLAN device megfelel a vonatkoz alapvet k vetelm nyeknek s az 1999 5 EC ir nyelv egy b el r sainak Italian Con la presente Welch Allyn dichiara che questo RLAN device conforme ai requisiti essenziali ed alle altre disposizioni pertinenti stabilite dalla direttiva 1999 5 CE Latvian Ar o Welch Allyn deklar ka RLAN device atbilst Direkt vas 1999 5 EK b tiskaj m pras b m un citiem ar to saist tajiem noteikumiem Lithuanian Siuo Welch Allyn deklaruoja kad is RLAN device atitinka esminius reikalavimus ir kitas 1999 5 EB Direktyvos nuostatas Malti Hawnhekk Welch Allyn jiddikjara li dan RLAN device jikkonforma mal htigijiet essenzjali u ma provvedimenti ohrajn relevanti li hemm fid Dirrettiva 1999 5 EC Portuguese Welch Allyn declara que este RLAN device est conforme com os requisitos essenciais e outras disposi es da Directiva 1999 5 CE Slovak Welch Allyn t mto vyhlasuje ze RLAN device sp a z kladn po_iadavky a v etky pr slu n ustanovenia Smernice 1999 5 ES Slovene Siuo Welch Allyn deklaruoja kad is RLAN device atitinka esminius reikalavimus ir kitas 1999 5 EB Direktyvos nuostatas Directions for Use Chapter 7 Compliance 65 Spanish Por medio de la presente Welch Allyn declara que el RLAN device cumple con los requisitos esenciales y cualesquiera otras disposiciones aplicables o exigibles de la Directiva 1999 5 CE
26. Micropage Monitor Directions for use Model 406 and Model 408 Software version 1 7X WelchAllyn Advancing Frontline Care ii Welch Allyn Micropaq Monitor 2010 Welch Allyn All rights are reserved No one is permitted to reproduce or duplicate in any form this manual or any part thereof without permission from Welch Allyn Welch Allyn assumes no responsibility for injury or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions cautions warnings or indications for use published in this manual Welch Allyn Acuity Micropaq and FlexNet are registered trademarks of Welch Allyn Nellcor is a registered trademark of Nellcor Puritan Bennett Masimo and SET are registered trademarks of Masimo Corporation Software in this product is copyright by Welch Allyn or its vendors All rights are reserved The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entitled to use the copy of the software incorporated within this instrument as intended in the operation of the product in which it is embedded The software may not be copied decompiled reverse engineered disassembled or otherwise reduced to human perceivable form This is not a sale of the software or any copy of the software all right title and ownership of the software remain with Welch Allyn or its
27. N device je ve shod se z kladn mi po adavky a dal mi p slu n mi ustanoven mi sm rnice 1999 5 ES Danish Undertegnede Welch Allyn erkl rer herved at f lgende udstyr RLAN device overholder de v sentlige krav og vrige relevante krav i direktiv 1999 5 EF Dutch Bij deze verklaart Welch Allyn dat deze RLAN device voldoet aan de essenti le eisen en aan de overige relevante bepalingen van Richtlijn 1999 5 EC English Hereby Welch Allyn declares that this RLAN device is in compliance with the essential requirements and other relevant provisions of Directive 1999 5 EC Estonian K esolevaga kinnitab Welch Allyn seadme RLAN device vastavust direktiivi 1999 5 EU p hin uetele ja nimetatud direktiivist tulenevatele teistele asjakohastele s tetele Finnish Welch Allyn vakuuttaa t ten ett RLAN device tyyppinen laite on direktiivin 1999 5 EY oleellisten vaatimusten ja sit koskevien direktiivin muiden ehtojen mukainen French Par la pr sente Welch Allyn d clare que ce RLAN device est conforme aux exigences essentielles et aux autres dispositions de la directive 1999 5 CE qui lui sont applicables German Hiermit erkl rt Welch Allyn die Ubereinstimmung des Ger tes RLAN device mit den grundlegenden Anforderungen und den anderen relevanten Festlegungen der Richtlinie 1999 5 EG Wien Greek ME THN MAPOYZA Welch Allyn AHAONEI OTI RLAN device ZYMMOPOONETAI TIPO TIZ OYZIQAEIZ ANAITHZEI KAI TIZ AOITIEX ZXETIKE AIATAZEIZ THX OAHTIA 1
28. Silence Micropaq alarms 36 ACUITY CONNECTION LOST 40 Acuity Menu END TELE 13 NEW PATIENT 13 NEW ROOM 13 TRANSFER 13 Adjust alarm limits at Micropaq 37 Alarm Alert Silence Key 11 Alarm holdoff with Acuity 58 Alarms Adjust alarm limits at Micropaq 37 Alarm holdoffs delays 35 Alarms off symbol 12 Download defaults from Acuity 21 Priority 58 Respond to patient alarms 36 Silence Alarms Key 11 Specifications 58 Alerts 35 Messages 40 Micropaq 38 Silence Alerts Key 11 Anemia and Sp02 27 Anesthetics Warning 4 Arterial occlusion and SpO2 27 Artifact interference and waveform display 22 Audible indicator 10 Autoclave caution about use 6 45 B Battery Changing 43 Low battery icon 12 Recharge 43 Recycling 47 Specifications 60 Battery charger Specifications 61 Use 43 Battery life Sleep mode 12 BATTERY TOO LOW 40 Beeps 10 Bell symbol 12 Blank display during sleep 12 C Cardiac arrest and SpO2 27 Cautions general 6 Change network name 48 Change the battery 43 Change waveform display 15 Charge a battery 43 Charger Recharge a battery 43 Specifications 61 Cleaning 45 Connect a new patient 19 21 Connect to the network 19 Customize alarms 21 D Default 76 Index Acuity and settings 16 51 Operating settings 16 51 DEFECTIVE SPO2 SENSOR 40 Defibrillation During Sp02 monitoring 26 Warning 4 Delays for alarms 35 Demo Mode Accessing 17 Display values
29. U S Government Printing Office Washington D C 20402 Stock No 004 000 0034504 Welch Allyn is not responsible for any radio or television interference caused by unauthorized modification of the devices included with this Welch Allyn product or the 64 Chapter 7 Compliance Welch Allyn Micropaq Monitor substitution or attachment of connecting cables and equipment other than specified by Welch Allyn The correction of interference caused by such unauthorized modification substitution or attachment will be the responsibility of the user Industry Canada IC emissions This device complies with RSS 210 of Industry Canada Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of this device L utilisation de ce dispositif est autoris e seulement aux conditions suivantes 1 il ne doit pas produire de brouillage et 2 utilisateur du dispositif doit tre pr t accepter tout brouillage radio lectrique recu m me si ce brouillage est susceptible de compromettre le fonctionnement du dispositif This Class B digital apparatus complies with Canadian ICES 003 Cet appareil num rique de la classe B est conform la norme NMB 003 du Canada European Union Czech Welch Allyn t mto prohla uje ze tento RLA
30. Visual alarm indications are not delayed Patient Alarm Tone Silence from the monitor or Suspend from Acuity The monitor LED is continuously ON RED and the audio tone is silenced for 90 seconds non adjustable If original alarm was silenced from the monitor new patient alarms or equipment alerts break the silence at the monitor but only life threatening arrhythmia alarms break the silence at Acuity If original alarm suspended at Acuity only life threatening arrhythmia alarms break the silence at the monitor and Acuity Equipment Alert Acknowledge from the monitor The LED returns to the pre alert state except Low Battery remains continuously ON YELLOW and the auditory tone is dismissed Equipment Alert Suspend from Acuity The LED is continuously ON YELLOW and the audio tone is silenced for 90 seconds non adjustable Patient Alarm Tone Reset from the monitor or Resume from Acuity For a patient alarm tone that has been silenced resets the tone Patient Out of Range Transmitter Failure An equipment alert is generated whenever the monitor fails to communicate to an Acuity System after a connection has been successfully established In addition the No Acuity icon is displayed on the monitor display Directions for Use Chapter 6 Reference 59 Characteristic Specification Transmitter Battery Failure An equipment alert is generated before the monitor battery becomes exhausted a Toh
31. a hazard when walking or moving Adult carrying pouch The Adult Carrying Pouch is intended for ambulatory adult patients It is not intended for use while the patient is in bed 1 Put the carrying pouch on the patient and insert the monitor 2 Carefully arrange the pouch and monitor on the patient to avoid bruising or other skin injuries To maximize the monitor s wireless transmission range always make sure that the monitor display is facing out and away from the patient s body Pediatric carrying pouch The Pediatric Carrying Pouch is intended for ambulatory pediatric patients 40 to 80 Ibs 18 to 36 kg It is not intended for use while the patient is in bed 1 Insert the monitor into the pouch 2 Carefully arrange the pouch and the monitor on the patient to avoid bruising or other skin injuries To maximize the monitor s wireless transmission range always make sure that the monitor display is facing out and away from the patient s body Directions for Use Chapter 2 Monitoring 29 Monitor a patient out of range of Acuity While out of range of Acuity the monitor continues to monitor the patient and provide local HR PR and SpO2 alarms or alerts at the monitor as needed When the patient wearing the monitor goes out of range of Acuity do the following 1 A DROPOUT equipment alert occurs at the Acuity Central Station Acknowledge the alert at Acuity 2 An equipment alert occurs at the monitor with this me
32. a time After a battery begins recharging as indicated by the green LED that flashes on one second off one second it is typically fully recharged within four hours at room temperature After a battery is fully charged the charger continues to maintain the full charge on the battery until the battery is removed Leaving a fully charged battery in the charger will not harm the battery Remove batteries from the battery charger if the battery charger will be disconnected from ac power for more than a few days Do not block the cooling vents at the rear of the battery charger The monitor battery charger only charges four batteries at a time A battery is not fully charged until the green LED is on continuously Do not remove a battery until it is fully charged or displays a battery fault WARNING The monitor battery is Lithium lon Do not incinerate submerge A crush disassemble or autoclave If a battery has been submerged in liquid discard the battery properly do not try to recharge or reuse the battery Do not short the battery terminals Do not try to connect the battery to any device except the monitor or the monitor battery charger Do not expose to high temperature above 60 C or 140 F Use only the specified monitor battery charger Directions for Use Chapter 5 Maintenance 45 Inspect the monitor batteries battery charger and accessories WARNING Be sure to unplug the monitor battery charger power cord from the A electr
33. aining dyes that change usual arterial pigmentation may cause erroneous readings WARNING Although the SpO alarm limit range can be adjusted down to 50 saturation with Acuity 6 0 software or higher the SpO gt performance and accuracy is not specified below 70 Directions for Use Chapter 6 Reference 57 Pulse oximetry SpO specifications Nellcor SpO2 complies with EN ISO 9919 2005 Characteristic Specification Saturation 96 SpO Range Resolution Alarm Limits With Acuity 6 0 or higher With Acuity 5 4X or lower 196 to 10096 196 5096 to 9996 lower 5196 to 10096 upper 8096 to 9996 lower 8196 to 10096 upper Probe Accuracy Adults Pediatrics 7096 to 10096 096 to 6996 unspecified OxiMax Max A Max AL 2 counts OxiCliq N 2 5 counts D YS 3 counts DS 100A 3 5 counts Pulse Rate Range Resolution Alarm Limits 26 to 239 beats per minute 1 beat per minute 25 to 245 beats per minute lower 30 to 250 beats per minute upper Pulse Rate Accuracy 3 beats per minute Display Update Interval at the monitor 1 second Alarm Hold Off Time Period 10 seconds resets if the sensor reports levels within limits before 10 seconds elapses Circuitry Microprocessor controlled Automatic self test of oximeter when powered on Automatic setting of default parameters Automatic alarm messages Electrosurgery interference suppression Yes Sensor Compatibili
34. alert from the monitor or Acuity Note The flashing green LED indicates that the monitor is connected to the network but not necessarily connected to a patient If the monitor is actively monitoring a patient the green LED indicates no alarms or alerts are detected Audible alarm indicator Beeps to indicate a patient alarm and beeps faster for life threatening arrhythmia alarms see Patient alarm and equipment alert specifications on page 58 Beeps to indicate when the equipment needs attention This beep tone is slower than patient alarm tones see Patient alarm and equipment alert specifications on page 58 Volume can be configured as high low or off configured at Acuity Volume can be configured differently for network connection or stand alone operation configured at Acuity Snapshot key When connected to Acuity pressing this key sends a snapshot of the patient s numeric and waveform data to the Acuity Central Monitoring System Depending on how Acuity is configured this will cause Acuity to print a 21 second snapshot 14 seconds of history 7 seconds of data after the button is pressed to the Acuity central station printer Note Snapshot is the default selection of the monitor However the connected monitor will inherit the configuration previously defined by Acuity For example if Acuity has defined the Snapshot key to respond with a Nurse Call function and a new monitor is introduced to the system the Sna
35. atients 20 List of rooms 21 Lithium ion battery 43 Lockout menu 14 51 Low battery icon 12 LOW BATTERY message 40 M Magnetic Resonance Imaging see MRI Directions for Use Main Menu EXIT 13 Menu Lock option 14 51 Restricting access 14 Maintenance Inspection and cleaning 45 Operator maintenance 43 Masimo SET technology 7 Menu Lock option 14 51 Messages for alerts 40 Messages from Acuity 16 Micropaq Acuity messages 16 Adjust alarm limits 37 Alarms 36 Audible indicators 10 Automatic reconnection 8 Battery recharging 43 Communication with network 8 Connect to the network 19 Default operating settings 16 Default settings 51 Demo Mode 17 Equipment alert 38 Features 7 NEW PATIENT 34 Operating settings 16 Out of range operation 8 Reassign to new patient 34 Specifications 52 Monitor Audible indicators 10 Features 7 Out of range 29 Recycling 47 Specifications 52 Monitoring At Acuity 41 Connect a new patient 19 Reconnect a recently monitored patient 31 Stop monitoring a patient 30 Motion interference and SpO2 27 MRI Warning do not use monitor 4 21 N Nellcor OxiMax technology 7 Neonatal Not intended for use 4 Network Access points 8 Automatic reconnection 8 Index 77 Connect the monitor 19 Disconnection symbol 12 Ethernet 1 FlexNet 8 Name change 48 Operation out of range 8 NEW PATIENT 13 34 NEW ROOM 13 32 NIBP While monitoring Sp
36. ch Allyn Micropaq Monitor 43 D Maintenance This section provides information to help operators of the monitor and the battery charger perform routine maintenance activities such as changing or recharging batteries inspection and cleaning Change the battery 1 Remove the depleted battery 2 Insert a fully charged battery Use only batteries supplied by Welch Allyn WARNING Before installing a battery carefully inspect the battery case If A there are any signs of damage cracks or leaks discard the battery properly and do not use it Note The Acuity unit can be configured to allow you a short time typically 30 seconds or more to change the monitor battery while the monitor is connected to the network without causing an Acuity equipment alert If the monitor is connected to the network and the battery is removed for longer than the allowable battery changing time Acuity generates a DROPOUT equipment alert at the Acuity Central Station Recharge a battery Eight bay battery charger 1 On the monitor battery charger 008 0651 XX choose an empty battery well where the LED is off 2 Insert the depleted battery into the battery well 3 Confirm that the charger displays a flashing green LED by the battery to indicate the battery is detected or is charging 4 When the green LED is on continuously the battery is fully charged Remove the battery 44 Chapter 5 Maintenance Welch Allyn Micropag Monitor If the
37. ck If it is contact your biomedical engineering department System Error Thread nnm Error ID nnm The equipment problem is so serious the monitor cannot be used e Contact your biomedical engineering department a This alert message can be acknowledged from Acuity but not from the monitor n 4 Monitor patient at Acuity While the Micropag is connected to the FlexNet network patient data gathered by the monitor is continuously stored at Acuity You can access this patient information at the Acuity Central Station and perform administrative functions including A Admit and discharge a patient in the Acuity unit Edit the patient description name physician etc Review and print patient data such as trends and waveforms Suspend patient alarm tones for 90 seconds and resume the alarm tones WARNING When the monitor moves out of range of the Acuity network communication with Acuity is broken immediately stopping the communication of patient vital signs data If the monitor is out of range of the Acuity network for several minutes the radio enters a low power state When the monitor is again within range of the Acuity network it can take as long as three minutes to restore communication with Acuity and resume the communication of patient vital signs data For more information about using the Acuity Central Workstation refer to Acuity Directions For Use 42 Chapter 4 Monitor patient at Acuity Wel
38. ct Room at Central and press Y The patient room will need to be entered later at the monitor see Reassign a monitored patient to a new room in the same unit on page 32 or at Acuity see Monitor patient at Acuity on page 41 6 If you need to customize alarm limits for your patient see Customize patient alarm limits at the monitor on page 37 Perform ECG monitoring A WARNING Motion artifact can cause incorrect heart rate readings Minimize patient motion whenever possible WARNING If a disconnected lead is in too close proximity to other electrical devices it may cause false heart rate readings WARNING The monitor does not provide internal arrhythmia analysis Therefore arrhythmias may cause the monitor to display inaccurate heart rates WARNING The monitor will show for HR numerics between 301 and 350 beats per minute Above 350 beats per minute it may display incorrectly low heart rates due to intermittent picking of R waves WARNING Do not use the monitor in a Magnetic Resonance Imaging MRI suite or a hyperbaric chamber Such use can cause fire or explosion resulting in patient injury and monitor damage WARNING Pacemaker signals can differ from one pacemaker to the next The Association for Advancement of Medical Instrumentation AAMI cautions that in some devices rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias Do not rely entirely
39. ct access to the Main Menu a Menu Lock option can be configured for the monitor at the Acuity Central Station When the Menu Lock is enabled the operator must press and hold down y and wg for two seconds to gain access to the Main Menu The Menu Lock is disabled if the monitor loses communication with Acuity Directions for Use Chapter 1 General information 15 Waveform options There are four ECG waveform options as shown HR 5p02 BPM 80 9 zE 37 1 Waveform 2 Waveforms The single ECG 1 lead Il ECG 1 lead II and ECG 2 waveform is displayed lead V are both displayed i John Smith II inW cm John Smith II inV cm aa 5 Seconds Full Screen ECG 1 lead Il cascades from The single ECG 1 lead II waveform is one line to the other allowed to occupy most of the screen To change the waveform selection during operation 1 Press xg to display the Main Menu 2 Press xg as needed to highlight the current waveform selection Then press Y as needed to select the desired display 16 Chapter 1 General information Welch Allyn Micropaq Monitor Messages from Acuity The monitor displays messages sent from Acuity as needed including patient alarms and equipment alerts When Acuity messages are displayed they temporarily override information displayed on the lower half of the monitor screen Accessories Battery charger 8 battery Micropaq Direc
40. cuity Display sleep mode In order to extend battery life the display becomes blank after two minutes if no keys are pressed The display becomes active again if an alarm or alert occurs a key is pressed the initial Acuity connection occurs a cable is inserted or an electrode is attached The display will not become blank if a patient alarm is occurring an Acuity message is displayed or the monitor is in Demo mode or Service mode Directions for Use Main Menu Chapter 1 General information 13 When you first press yw the Main Menu appears Press ww to move through the menu Press xto select or change the highlighted choice q EXIT ACUITY ECG LEAD EXIT ADUITY ECG LEAD ECG SCALE 7 Exit the Main Menu the menu disappears Access the Acuity Menu with network options The Acuity Menu is only accessible while connected to Acuity EXIT Exit all menus and return to the monitoring screen END TELE Discontinue monitoring a patient NEW ROOM Reassign a patient to a new room in the same unit TRANSFER Transfer a patient to a new room in a new unit NEW PATIENT Assign the monitor to a new patient PATIENT INFO Display patient information such as ID name unit and room Whenever the monitor is connected to Acuity and you select ACUITY from the Main Menu the monitor displays the message ACUITY CONTACTED to confirm that Acuity has been contacted The monitor contin
41. dance RF emissions Group 1 The Battery Charger uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The Battery Charger is suitable for use in all establishments CISPR 11 including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings Harmonic emissions Class A used for domestic purposes IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Directions for Use Chapter 7 Compliance n Monitor Battery Charger Only Guidance and Manufacturer s Declaration Electromagnetic Immunity The Battery Charger for the Model 4XX Series Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the monitor should assure that it is used in such an environment Immunity Test IEC 60601 Test level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete or ceramic ESD 8 kV air 8 kV air tile If floors are covered with synthetic IEC 61000 4 2 material the relative humidity should be at least 30 Electrical fast 2 kV for power supply 2 kV for power Mains power quality should be that of a transient burst lines supply lines typical co
42. e has been tested and certified by requirements of European Medical Device c us International to comply with applicable U S Directive 93 42 EEC and Canadian medical safety standards Restrictions for use of wireless device in Signifies the device has met all essential C Europe European Communities Class 2 radio C requirements of European Medical Device equipment Directive 93 42 EEC for a Class 1 product battery charger Protective earth ground battery charger y Separate batteries from other disposables for amp ds recycling Li Lithium lon battery For indoor use only battery charger Caution Refer to Directions For Use and accompanying documentation Keep away from rain See the accompanying manual Recycle the monitor and battery separately from other waste Refer to www welchallyn com weee for collection point and additional information D DD Alarm s off Patient connections are Type CF isolated for irect cardiac application and protecte ANGIE di diac application and d against defibrillation i i This way up Stacking limit by number m E 95 Humidity limit ates Altitude limit Fragile IATA ICAO Hazard Class 9 Package 9 International Air Transport Association International Civil Aviation Organization Single use only O e I Temperature limits Directions for Use Chapter 1 General information 3 Symbol Ka Definition Non ionizing electromagnetic
43. electrode contact e Check and replace ECG electrodes as needed Chest icon is displayed with flashing ECG electrode s The monitor detects that one or more ECG electrodes are disconnected e Check and replace or reconnect electrodes as needed NO ECG CABLE DETECTED e Ifthe ECG cable has been intentionally removed from the monitor press to cancel the alert tone the ECG cable has been unintentionally removed plug it back into the monitor Check the patient and monitor to make sure ECG monitoring resumes properly is normal for this alert to appear with a 3 lead ECG cable when two or more of its leads are disconnected from the patient Reconnect the disconnected lead wires NO SPO2 SENSOR DETECTED The SpO sensor has been disconnected for more than 5 seconds disconnection is intentional press to acknowledge and silence the tone disconnection is not intentional reconnect the sensor or replace the sensor and reconnect DEFECTIVE SPO2 SENSOR The SpO sensor is either defective or not recognized or e Replace the Sp0 sensor with a new compatible SpO sensor UNRECOGNIZED SPO SENSOR lt key name gt KEY STUCK During the power up self test the monitor detected that a key is stuck ww s TS or x This can happen if you accidentally press a key down before the Main Menu is displayed during power up e Remove and then reinsert the battery to power up again and see if the key is still stu
44. elp minimize false alarms the monitor briefly delays or holds off triggering both audible and visual alarms for limit violations for these vital signs After the alarm hold off period begins if the monitor detects that the patient s vital sign has returned to acceptable limits the monitor cancels the alarm hold off The next time a vital sign limit is violated the monitor starts a new hold off period Display specifications Characteristic Specification Type Monochrome passive matrix LCD module Resolution 320 x 200 pixels Active Viewing Area 2 26 x 1 41 in 57 5 x 35 9 mm Pixel Pitch 0 0071 in 0 18 mm Pixel Size 0 0065 in 0 165 mm Viewing Angle 6 o clock position Display Color black on white Environmental specifications with battery installed Characteristic Specification Operating Temperature 0 to 40 C Shipping and Storage Temperature 20 to 60 C Operating Altitude 2 000 to 15 000 ft 610 to 4 572 m Shipping and Storage Altitude 2 000 to 40 000 ft 610 to 12 192 m Operating Relative Humidity 15 to 95 noncondensing per MIL STD 810E Procedure 1 natural Shipping and Storage Relative Humidity 15 to 95 noncondensing per MIL STD 810E Procedure 1 natural Drop 1 meter onto vinyl tile over concrete per EN60601 1 Shock 50g Vibration Random 0 02g2 Hz from 10 to 500 Hz ramping down to 0 002g2 Hz at 2000 Hz Operating 1 h
45. er WARNING Use only accessories as listed in the Welch Allyn Products and Accessories booklet 810 0409 XX Use only Masimo accessories and sensors with the Masimo SpO option Use only Nellcor accessories and sensors with the Nellcor SpO option The monitor will only meet the listed specifications when using accessories listed by Welch Allyn WARNING Use of Masimo LNOP sensors cables will not provide protection in accordance with IEC defibrillation standards when used with this device WARNING Tissue damage can be caused by incorrect application or use of a sensor e g wrapping the sensor too tightly applying supplemental tape failing to periodically inspect the sensor site leaving a sensor on too long in one place Refer to the Directions for Use provided with each sensor for specific instructions on application and use and for description warnings cautions and specifications WARNING Sensors exposed to ambient light while not applied to a patient can exhibit semi normal saturation readings Be sure the sensor is securely placed on the patient and check its application often to ensure accurate readings WARNING Inaccurate measurements may be caused by venous pulsations WARNING The pulse oximeter can be used during defibrillation but the readings may be inaccurate for a short time WARNING The pulse oximeter should NOT be used as an apnea monitor WARNING A very sudden and substantial change in pulse rate can result in
46. erformance To overcome these limitations the 5 lead ECG monitoring is preferred The monitor s 3 lead ECG monitoring is only available for use with Acuity software versions 6 1 or later You can perform 3 lead ECG monitoring in a similar manner as 5 lead ECG monitoring You may use the 5 lead ECG cable with detachable electrode lead wires and connect only the lead wires and electrodes for RA LA and LL Refer to the Welch Allyn Product and Accessories booklet 810 0409 XX for part numbers Follow these steps 1 2 Perform Step 1 through Step 4 on page 23 as described for 5 lead ECG monitoring Before attaching electrodes to the patient attach only lead wires for RA LA and LL to the 5 lead ECG trunk cable and to the electrodes Make sure that lead wires for C and RL are DETACHED from the 5 lead ECG trunk cable Apply the electrodes for RA LA and LL to the patient in the proper locations The monitor displays the chest diagram with two circles blinking confirming that the C and RL electrodes are not connected Observe the monitor and visually confirm that within about 30 seconds the two circles disappear and the monitor displays the ECG waveform heart rate and other patient data Be aware that if you connect the C or RL lead wires to the 5 lead ECG trunk cable and apply the C or RL electrodes to the patient the monitor defaults to 5 lead ECG monitoring and does not enable 3 lead ECG monitoring To enable 3 lead ECG moni
47. erify patient mode at Acuity Incorrect patient mode may result in inaccurate heart rates and inappropriate alarm settings WARNING To help prevent injury use the provided garment clips to route the ECG cables away from the patient s head WARNING Use of ECG cables with loose or faulty detachable lead wires may cause erratic behavior of the ECG waveform due to intermittent ECG lead wire connections WARNING To ensure patient safety the conductive parts of the ECG electrodes including associated connectors and other patient applied parts should not contact other conductive parts including earth ground at any time Caution To protect the monitor from damage during defibrillation for accurate ECG information and for protection against noise and other interference use only ECG electrodes and cables specified or supplied by Welch Allyn these cables have the required current limiting resistors Follow recommended application procedures Caution Do not use an ECG cable longer than 10 feet 3 meters If the nominal length of the ECG cable including extensions exceeds this length the monitor is not guaranteed to meet published electromagnetic compatibility EMC performance specifications e Even though the monitor contains fully isolated patient connected circuitry it has not been specially designed for direct application on a patient s heart e Use only with accessories provided or recommended in the Welch Allyn Products and Accesso
48. erval at monitor 1 second Alarm Hold Off Time Period 10 seconds resets if the sensor reports levels within limits before 10 seconds elapses Circuitry Microprocessor controlled Automatic self test of oximeter when powered on Automatic setting of default parameters Automatic alarm messages Electrosurgery interference suppression Yes Sensor Compatibility Compatible only with Masimo sensors listed in the Micropaq monitor section of the Welch Allyn Products and Accessories booklet 810 0409 XX For probe sensor compliance to EN ISO 9919 2005 see the Masimo directions for use Sensor LEDs RED Wavelength INFRARED Wavelength 660 nm nominal 905 nm nominal Sensor Energies Radiant Power 0 13 mW to 0 79 mW at 50 mA pulsed a Sp0 alarm limit range depends on the software version of the Acuity System to which the monitor is connected b Motion is defined as rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a nonrepetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 100 SpO against a laboratory co oximeter and ECG monitor This variation equals 1 standard deviation which encompasses 68 of the population WARNING A Interfering Substances Carboxyhemoglobin may erroneously increase readings The level of increase is approximately equal to the amount of carboxyhemoglobin present Dyes or any substances cont
49. eter or intravascular line Loss of pulse signal can occur if the sensor is too tight there is excessive ambient light an NIBP cuff is inflated on the same limb as the sensor there is arterial occlusion proximal to the sensor the patient is in cardiac arrest or shock or the patient has hypotension severe vasoconstriction severe anemia or hypothermia Inspect the SpO cable Replace it if it shows any signs of wear breakage or fraying Plug the cable into the sensor and the monitor After the cable is connected confirm that the monitor displays SpO data within a few seconds If excessive patient movement interferes with measurements consider the following possible solutions e be sure the sensor is secure and properly applied e use anew sensor with fresh adhesive backing e select a different type of sensor e move the sensor to a less active site The SpO system is designed to work satisfactorily during normal patient motion 28 Chapter 2 Monitoring Welch Allyn Micropaq Monitor Install the carrying pouch WARNING As with all medical equipment carefully route the patient cabling to A reduce the possibility of patient entanglement or strangulation Use the supplied garment clips to secure the cable properly WARNING When positioning the monitor pouch on the patient make sure the straps do not entangle the patient s neck or cause choking Make sure the straps do not restrict the movement of the patient s limbs or create
50. evious Monitor Default Monitor ForEach ForEntire Setting Setting Patient Acuity Retained at Unit Monitor at Power Up Patient Mode No Yes No Yes Adult Adult age 13 years and older Pediatric age greater than 28 days of age or more than 44 weeks gestation up to 12 years ECG screen mode Single Dual 5 Yes No Yes Yes Single Sec or Full Screen ECG 1 Lead Selection Yes Yes Yes Yes ll ECG 2 Lead Selection Yes Yes Yes Yes V or Ill if no V lead ECG Size Scale Yes No No Yes 1 mV cm Language No No Yes Yes English Mains Filter off 50 or 60 Hz No No Yes Yes 60 Vital Signs Alarm Volume high low or off With Acuity Connection No No Yes No off Without Acuity Connection No No Yes Yes high Equipment Alert Volume high low or off With Acuity Connection No No Yes No off Without Acuity Connection No No Yes Yes low HR PR Alarm Limits Yes Yes Yes Yes Adult 50 120 bpm Lower Upper Ped 50 150 bpm Sp0 Alarm Limits Yes Yes Yes Yes Adult 90 100 Lower Upper Ped 90 10096 Regulatory settings No No Yes Yes US U S Europe Japan Pacer Detection Enable No Yes No Yes On Menu Lockout No No Yes No Off Display Backlight Timeout No No Yes Yes 120 seconds a Set by clinician at Acuity Central Station b Set by Acuity System Administrator during system installation C SpO alarm limit range depends on the software version of the Acuity System to which the monitor i
51. f functional oxygen saturation of arterial hemoglobin SpO gt and pulse rate measured by an SpO sensor The most likely locations for patients monitored by this device are step down units telemetry departments general medical surgical floors emergency departments and in hospital transport This guide was written for clinicians Although this guide may describe some monitoring techniques Welch Allyn expects that the operator is a trained clinician who knows how to take and interpret a patient s vital signs Federal USA law restricts sale of the device identified in this manual to or on the order of a licensed medical practitioner 2 Chapter 1 General information Welch Allyn Micropaq Monitor Symbols Warning Warning statements in this manual identify conditions or practices that could result in personal injury A Caution Caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property Caution On the product means Consult the accompanying documentation The following symbols appear on the monitor or accessories Symbol Definition Symbol Definition Direct curren IPX1 Enclosure Protection Drip proof Classification aga IPX1 per EN60529 1991 AG Alternating current battery charger Fuse C os Number signify the device has met all essential e the Canadian Standards Association The CE Mark and Notified Body Registration This devic
52. f the following pre set names com protocol demo protocol com1 protocol com2 protocol com3 protocol com4 protocol comb protocol com6 protocol com 7 protocol com8 protocol then the monitor displays the following screen NETWORK NAME MENU NOT INTENDED FOR PATIENT USE ARE YOU SURE NETWORK NAME MENU Qj Directions for Use Chapter 5 Maintenance 49 To change the network name make sure YES is highlighted then press Y to display the following screen NETWORK NAME MENU CURRENT NETWORK NAME demo protocol EXIT NETWORK NAME MENU com protocol demo protocol com1 protocol Press s or wr to highlight the desired network name then press X The monitor automatically turns itself off then turns on and seeks to connect to a FlexNet network with the new network name If the current network name is a custom name the monitor displays the following screen NETWORK NAME MENU CURRENT NETWORK NAME custom protocol THIS IS A CUSTOMIZED NETWORK NAME IT CANNOT BE CHANGED FROM THIS MENU PREVIOUS MENU NETWORK NAME MENU Qj You cannot change the network name using the Network Name Menu Press X to return to the Service Menu Contact Welch Allyn Technical Support for assistance 50 Chapter 5 Maintenance Welch Allyn Micropaq Monitor 51 Reference Operating settings The following table lists all of the monitor settings and the default settings Parameter Set at Set at Acuity Pr
53. form and Sn02 a numerics are displayed zE Demo Mode Display Values and Alarm Limits Display Demo 1 Demo 2 Alarm Limits 0n ECG Waveform Normal sinus rhythm Normal sinus rhythm not applicable normal ST normal ST ECG Heart Rate 80 125 Lower 50 Sp0 Pulse Rate Upper 120 Sp0 Saturation 97 88 Lower 90 Upper 100 a Demo 2 will cause patient alarms 8 While in Demo mode you can practice changing settings such as ECG lead selection and alarm limit adjustment These changes only affect the Demo mode and are erased when you exit the Demo mode 9 To change to the other Demo selection press wr to display the menu then scroll down to highlight TOGGLE DEMO MODE and press X 10 To exit the Demo mode either insert a patient cable or remove and insert the battery The monitor restarts and enters the normal monitoring mode 19 Monitoring Connect a new patient Connect to the network 1 Insert a battery into the monitor to turn it on After a few seconds the monitor Power Up Screen is replaced by an initial monitoring screen Me If any patient cables are connected there will be some patient data displayed The format depends on the AE monitor default settings The monitor is searching for a DRE network connection Example of Initial Monitor Screen 2 After the network connection is established the monitor may prompt you to select an Acuity Unit if your facility has more than o
54. g solutions on page 46 Do not use any solution or solution with similar constituents listed in Prohibited cleaning solutions on page 46 a Do not allow cleaning solution to accumulate anywhere on the device b Inspect to ensure no cleaning liquid is present in connector openings latches or crevices 2 After cleaning thoroughly remove residual cleaning solution by wiping all surfaces with a clean soft cloth dampened with water 3 Thoroughly dry all surfaces with warm air 46 Chapter 5 Maintenance Welch Allyn Micropag Monitor Clean the accessories WARNING Do not autoclave the accessories Never immerse the accessories in liquid unless the accessory manufacturer explicitly instructs you to do so Clean accessories per manufacturer s instructions Approved cleaning solutions Brand names Coverage Wex cide Sani Cloth Cidex Plus Betadine Generic Warm water Liquid soap Hydrogen peroxide solution a Wex cide Wexford Labs Inc Kirkwood MO is a disinfectant that meets OSHA requirements is EPA approved and will not harm the outside of the monitor battery or battery charger Wipe away disinfectant after the manufacturer s recommended period b Sani Cloth Wipes are proven effective in 5 minutes or less Sani Cloth Wipes are EPA registered and meet CDC and OSHA guidelines They are an adequate substitution for Theracide Disinfectants Prohibited cleaning solutions Caution Use only cleaning so
55. gnetic Compatibility EMC EN60601 1 2 2001 Physical Specifications Length 15 0 in 38 1 cm Width 9 0 in 22 9 cm Height 3 6 in 9 1 cm including feet Weight 3 5 Ib 1 6 kg Electrical Specifications Rated Input 100 V 240 V AC 600 mA 50 60 3 Hz Electrical Class Rated Fuses 71 25 A 250V Time Delay 5x20mm Rated Output per charging bay 8 4 V x 100 mV dc Q1 A max Continuous Charge Time 4 hours typical for fully discharged battery Automatic charge termination when charge is completed or fault detected Output Over Current Electronic overload protection Additional Features Detachable power cord LED Indicators LED OFF No battery detected Flashing GREEN LED 1 sec ON 3 sec OFF 1 sec ON 1 sec OFF Battery detected waiting to be charged Battery is charged Continuously ON GREEN LED Battery is charged Continuously ON YELLOW LED Battery or charging bay fault a Per EN 60601 1 unless otherwise stated 62 Chapter 6 Reference Welch Allyn Micropaq Monitor 63 Compliance General The 802 11a Wireless PC Card must be installed and used in strict accordance with the manufacturer s instructions as described in the user documentation that comes with the product This product contains encryption It is unlawful to export out of the U S without obtaining a U S Export License Federal Communications Commission FCC This device complies with part 15
56. h lead wires to the electrodes before applying them to a patient Apply the electrodes for RA LA and LL to the patient at the proper locations If the monitor detects one of the lead wires is not properly connected it will display a chest diagram indicating which lead is disconnected Observe the monitor and visually confirm it displays the ECG waveform heart rate and other patient data Be aware that only ECG lead II is available for display with the monitor s 3 lead monitoring No other ECG lead selections are available The monitor will not detect the presence of a 3 lead cable until two or more of its leads are connected to the patient 3 Lead ECG application with the 3 Lead ECG cable and cable extension This combination functions the same way as the 3 lead ECG application with the 5 lead cable For electromagnetic compatibility EMC reasons do not use an ECG cable and extension cable length of more than approximately 10 feet total 26 Chapter 2 Monitoring Welch Allyn Micropaq Monitor Perform Sp0 monitoring A WARNING Oxygen saturation measurements using pulse oximetry are highly dependent on proper placement of the sensor and patient conditions Patient conditions such as shivering and smoke inhalation may result in erroneous oxygen saturation readings If pulse oximetry measurements are suspect verify the reading using another clinically accepted measurement method such as arterial blood gas measurements on a co oximet
57. hed identification number on the front of the monitor ECG monitoring ECG monitoring and either one of two pulse oximetry SpO5 monitoring options SpO with Masimo SET technology indicated by jMyio FT SpO with NELLCOR OxiMax technology indicated by exu 8 Chapter 1 General information Welch Allyn Micropaq Monitor Understanding the monitor and the FlexNet Network The monitor is intended to operate with an Acuity9 Central Station as part of Welch Allyn s FlexNet network FlexNet allows multiple devices to communicate through hardwired Ethernet networks and Wireless Local Area Networks WLANSs The Acuity Central Station provides the primary display and entry of patient data for a patient connected to the monitor To Other Acuity To Other Central Stations Access Access Points Points Acuity Central Station Micropaq monitors FlexNet Network Each patient worn monitor supports two way communication with an Acuity Central Station through an access point in the FlexNet network The access point is a digital radio transceiver that connects to the FlexNet network During monitoring the monitor sends the patient data to Acuity Acuity and the monitor continuously analyze the data Acuity provides appropriate alarm or alert messages at the Central Station and other network devices such as a hallway message panel and the monitor itself Acuity also stores the patient data for viewing or report printing
58. hillips Mary L patients to 532 94 8372 Smith Frank R v select Example of Patient List 5 Scroll through the patient list to look for your patient s name e f your patient is not in the list highlight Select Patient at Central and press x The patient name will need to be entered later at the Acuity Central Station WARNING f you do not select the patient name at the monitor at this time do A not adjust any alarm limits until after the patient name and ID are confirmed at Acuity When the patient name and ID are confirmed at Acuity Acuity downloads the default settings and patient alarm limits for that Acuity unit to the monitor thereby overriding any previous settings and alarm limits Note At power up the monitor retains the most recent patient mode The patient mode can only be changed at Acuity If the patient is being monitored when the patient mode is changed there is a brief interruption in the display and recording of ECG and SpO patient data Directions for Use 1104A ROOM Possible 1104B rooms to 1105A Y select Chapter 2 Monitoring 21 If your patient is in the list highlight the name and press x Within a few seconds the monitor displays a list of unassigned rooms Select Room at Central SELECT Example of Room List If you want to assign the patient to a room highlight the room and press X If you do not want to assign a room at this time highlight Sele
59. ical power outlet before inspecting the battery charger Before cleaning thoroughly inspect the monitor and all accessories for any signs of damage cracks or improper mechanical function of the keys or connectors While gently bending and flexing the cables inspect for damage cracks cuts abrasions extreme wear exposed wires or bent connectors Confirm that the connectors are securely seated Remove damaged items from use and report damage or improper function to your service department At least every 12 months be sure to thoroughly inspect the battery charger case and power cord for damage or extreme wear Clean the monitor batteries and battery charger WARNING Unplug the monitor battery charger power cord from the electrical A power outlet before cleaning the battery charger Exposing the battery charger to liquids while connected to electrical power could result in electrical shock or fire WARNING Do not autoclave the monitor battery or battery charger Never immerse the monitor battery or battery charger in liquid Note The monitor battery and battery charger may be disinfected to comply with OSHA requirements for cleaning and decontaminating spills of blood and other body fluids For more information refer to the Federal OSHA Standard on bloodborne pathogens 29 CFR 1910 1030 12 6 91 1 Wipe the equipment with a nearly dry clean cloth moistened with one of the approved cleaning solutions listed in Approved cleanin
60. icropaq Monitor A A WARNING For patients with a pacemaker position the monitor to maintain a minimum 6 inch distance between the monitor and pacemaker Immediately turn the monitor off and provide appropriate patient care if you have any reason to suspect that the monitor is interfering with the pacemaker The Health Industry Manufacturers Association recommends this minimum 6 inch distance between a hand held wireless radio and a pacemaker which is consistent with the independent research by and recommendations of Wireless Technology Research WARNING Make frequent electrical and visual checks on cables sensors and electrode wires All cables sensors and electrode wires must be inspected and properly maintained and in proper working order to allow the equipment to function properly and protect patient safety WARNING Avoid electrosurgery burns at monitoring sites by ensuring proper connection of the electrosurgery return circuit so that the return paths cannot be made through monitoring electrodes and probes WARNING Use of ECG and SpO cables not specified by Welch Allyn may negate defibrillator protection and risk patient injury WARNING Use of Masimo LNOP sensors cables will not provide protection in accordance with IEC defibrillation standards when used with this device WARNING To ensure patient safety the conductive parts of the ECG electrodes including associated connectors and other patient applied parts should not
61. in seconds For higher heart rates latest average interval 7 8 of previous average interval 1 8 of latest interval For lower heart rates latest average interval 3 4 of previous average interval 1 4 of latest interval Transition rates for choice of formula include hysteresis and are 70 and 80 beats per minute Drift Tolerance AAMI Specification EC13 1992 3 2 6 3 80 beats per minute indicated for 80 beats per minute ECG plus drift waveform Pacer Pulse Display Pacer indicator shown on screen if PACER display turned ON pacer spike always shown if of sufficient amplitude Pacer Pulse Rejection Pacer detection range i e will show the dashed vertical marker for 3 mV to 700 mV 0 1 ms width 2 mV to 700 mV 0 2 to 2 ms pulse width in electrically quiet environment Thresholds automatically adjust to reject repetitive ambient noise Operates even while pacer indication is disabled Will not count as heartbeats approximately 95 of pacemaker pulses within pacer detection range with or without AAMI EC13 1992 tails of 4 25 50 75 or 100 ms decay time constant whose tail amplitudes are up to 25 2mV maximum whether ventricular only or A V sequential pulses 150 and 250 ms separation all per AAMI tests 3 1 4 1 and 3 1 4 2 Response to Irregular Rhythm AAMI Specification EC13 1992 3 1 2 1 Part e Ventricular Bigeminy VB 78 to 81 bpm 80 bpm expected Slow Alternating VB 57 t
62. lutions that are recommended by Welch Allyn for A this equipment Use of solutions that are not recommended or that have a high acid content or are otherwise inappropriate can cause damage to the equipment including cracking and deterioration of the plastic case Do not use these solutions or similar products If your cleaning solution is not on the approved or prohibited cleaning solution lists check the cleaning solution ingredients to ensure that nothing listed in the prohibited cleaning solutions is a constituent element If you are unsure whether a cleaning solution should be used defer to the approved cleaning solutions list Brand names Freon Vesphene Enviroquat Staphene Misty Virex Formula 4099 Fantastik Ovation TBO Windex Generic Butyl alcohol Denatured alcohol Acetone Chlorine bleach solution 70 percent isopropyl alcohol Trichloroethane Trichloroethylene Glutaraldehyde Directions for Use Chapter 5 Maintenance 47 Recycling monitor components When the battery monitor or battery charger reaches the end of its life recycle it locally according to national state and local regulations You can also return the battery monitor or charger to Welch Allyn for recycling Within the European Union Do not dispose of this product as unsorted municipal waste Prepare it for reuse or separate collection as specified by Directive 2002 96 EC as amended of the European Parliament and
63. ly the electrodes to the patient in the proper locations eee Flashing circle indicates the TI inen ohn Smith lead is not connected Right Arm Left Arm Right Le Ts Left Le ay ly X If the monitor detects that some lead wires are not properly connected the monitor displays a chest diagram and indicates which leads are disconnected The locations of the circles displayed on the monitor for each lead are fixed and are not affected by the exact placement of the electrodes on the patient For example the C lead can be placed on the patient in any one of the V1 V6 locations desired but will only be displayed on the monitor in the location shown above After leads are properly connected confirm that the monitor displays the ECG waveform heart rate and other patient data To change the ECG lead selection press Y to display the Main Menu Then press Scroll Down to highlight ECG LEAD then highlight ECG 1 or ECG 2 and press Y to change the lead 24 Chapter 2 Monitoring Welch Allyn Micropaq Monitor 3 Lead ECG application with the 5 Lead ECG cable Note Be aware that there are some inherent limitations with this application especially when compared to 5 lead ECG monitoring These limitations include the restriction to only one displayed lead ECG lead ll Because only one displayed lead is available ECG lead II factors such as a poor electrode connection at RA LA or LL can significantly affect p
64. mmended below according to the maximum output power of Rated Maximum Output Power of Transmitter W Separation Distance m According to Frequency of Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 12 JP d 12 JP d 23 JP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 2 1 2 23 10 3 8 3 8 73 100 2 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 applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitte in watts w according to the transmitter manufacturer Note 1 At 80 MHz and 80 0 MHz the separation distance for the higher frequency range applies Note 2 and reflection from structures objects and people These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption 74 Chapter 7 Compliance Welch Allyn Micropaq Monitor Index 75 1 Waveform display 15 2 Waveform display 15 5 Second waveform display 15 A Accessories 16 Inspection and cleaning 45 Use only recommended 6 16 Access points 8 Acuity 8 Acuity Central Station 1 8 Alarm holdoff at Acuity 58 Default settings for Micropaq 51 Download default settings 21 DROPOUT equipment alert 30 Messages displayed on Micropaq 16 Micropaq operating settings 16 Monitoring at Acuity 41
65. mmercial or hospital environment IEC 61000 4 4 1 kV for input output 1 kV for input output lines lines Surge 1 kV differential mode 1 kV differential Mains power quality should be that of a IEC 61000 4 5 2 kV common mode mode typical commercial or hospital environment 2 kV common mode Voltage dips short lt 5 U lt 5 U Mains power quality should be that of a interruptions and gt 95 dip in U gt 95 dip in U typical commercial or hospital environment voltage variations on or 0 5 cycle or 0 5 cycle If the user of the Battery Charger requires power supply input 40 U 40 U continued operation during a power mains lines 60 dip in U 60 dip in U interruption it is recommended that the IEC 61000 4 11 or 5 cycles or 5 cycles Battery Charger be powered from an 70 U 70 U uninterruptible power supply or battery 30 dip in U 30 dip in U or 25 cycles or 25 cycles lt 5 U lt 5 U gt 95 dip in U gt 95 dip in U or 5 sec or 5 sec Power frequency 50 3 A m 3 A m Power frequency magnetic fields should be 60 Hz magnetic field IEC 61000 4 8 at levels characteristic of a typical location in a typical commercial or hospital environment Note U is the AC mains voltage prior to application of the test level 72 Chapter 7 Compliance Welch Allyn Micropaq Monitor Monitor Battery Charger Only Guidance and Manufacturer s Declaration Electromag
66. n Battery 008 0647 XX 2EA Active A Battery Type Rechargeable Lithium lon Battery Capacity 2 cells 7 4 V nominal 8 4 V charging 1800 mA hr Battery Weight 4 5 oz 0 13 kg Battery Charger External device Battery Fuse Rating 5 A 125 V not user accessible Note Internal electronic overload circuitry is used as the primary method of protection Operating Times on Battery Model 406 25 hrs Model 408 10 hrs Battery Recharge Time 4 hours at 25 C typical Battery Lifetime 300 charge discharge cycles to 7096 of original capacity typical a Battery operating times based on these conditions new fully charged battery operating at 25 C the monitor connected to Acuity eight patient alarms per hour minimal motion artifact Note e e e e The following factors may reduce battery operating time Amount of time not connected to Acuity Frequency and duration of alarms and alerts Amount of operator activity using monitor keys activates display Age of battery Amount of motion artifact during SpOs monitoring WARNING The monitor battery is Lithium lon Do not incinerate submerge crush disassemble or autoclave If a battery has been submerged in liquid discard the battery properly do not try to recharge or reuse the battery Do not short the battery terminals Do not try to connect the battery to any device except the monitor or the battery charger Do not expose to
67. n the monitor reconnects Directions for Use Chapter 1 General information 17 Demonstration mode You can practice using the monitor with the Demo mode of operation including connection to Acuity The Demo mode cannot be activated while you are monitoring a patient or if any cables have been plugged into the monitor During the Demo mode the monitor and Acuity display the message SIMULATION To practice with the monitor in Demo mode 1 Disconnect all patient cables connected to the monitor 2 Remove the battery if installed 3 Insert the battery and watch for the Power Up screen Model 4D8 English Adult Mode SOFTWARE VERSION 1 70 00 WELCH ALLYN PROTOCOL INC 19928 2007 Power Up Screen 4 After the Power Up screen disappears press to display the Main Menu LEN ADUITY ECG LEAD ECG SCALE T 18 Chapter 1 General information Welch Allyn Micropaq Monitor 5 Press to highlight SERVICE MENU then press Y to display the Service Menu DEMO MENU SERVICE MENU NOT INTENDED FOR PATIENT USE SERVICE MENU SYSTEM TEST UE E 6 Press wr to highlight DEMO MENU then press Service Menu Y to display the Demo Menu 7 Press wr to highlight DEMO 1 or DEMO 2 then press Y to start II inW emi Demonstration Mode SIMULATION indicates the Demo mode is active gt m A simulated wave
68. n them to a new room in a different unit follow these steps 1 2 Press wr to display the Main Menu Press wr again to highlight ACUITY and press X to display the Acuity Menu screen Press wr to highlight TRANSFER then press X END TELE MENU m ROON Transfer a Patient Within a few seconds the monitor displays a list of units Press Nw to highlight the new unit then press X The patient is not monitored at Acuity during the short time required by Acuity to process the transfer to the new unit typically less than one minute However the patient continues to be monitored by the monitor If the selected unit is currently not available the monitor displays an appropriate message press X to acknowledge the message and cancel the transfer After the patient is assigned to the new unit the monitor displays a list of unassigned rooms The patient s previous unit and room assignment is cancelled e Toassign the patient to a new room highlight the room and press X e f you decide not to assign the patient to a new room at this time you can highlight Select Room at Central and press Y You can then assign the room later from the Acuity Central Station or you can assign a new room from the monitor later using the procedure on Reassign a monitored patient to a new room in the same unit on page 32 34 Chapter 2 Monitoring Welch Allyn Micropaq Monitor Reassign the monitor to a new patient
69. ne Acuity unit Possible Acuity Unit esa selections EIU sd SELECT UNIT Press Sw to view more ER NICU Li Example of Acuity Unit Selection 20 Chapter 2 Monitoring Welch Allyn Micropaq Monitor 3 Press ww or to highlight the desired Acuity unit then press X When you press wr or to highlight the desired Acuity unit and then press X your selection will begin to flash between normal and reverse video to confirm that the monitor is communicating your selection to Acuity You cannot scroll to another selection during this time The selection continues to flash until Acuity responds back to the monitor Then the monitor displays the next appropriate screen such as a list of possible patients The length of time required for Acuity to respond to your selection at the monitor can vary widely depending on the amount of network traffic and other conditions Be sure to select an Acuity unit Even though the monitor is connected to the network as indicated by the green LED and 9 network connection symbol the Acuity Central Station may not Netvork Connecti n display any indication of this monitor until after you have selected an Symbol Acuity unit 4 The monitor displays a list of possible patients If your patient has been pre admitted to the selected Acuity unit they will be included in the list Select Patient at Central SELECT 428 02 2392 Hopkins Bill J PATIENT Possible 520 29 0318 P
70. netic Immunity The Battery Charger for the Model 4XX Series Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the battery charger should assure that it is used in such an environment Immunity test IEC 60601 Test Compliance Electromagnetic Environment Guidance Level Level Portable and mobile RF communications equipment should be used no closer to any part of the Battery Charger including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Conducted RF 3 Vims 3Vings 0212 JP IEC 61000 4 6 150 kHz to 80 MHz 2Hz AM Radiated RF 3 V m 3V m d 12 P 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz 2Hz AM d 23 JP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and d is the recommended separation distance in meters Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol t2 A Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply ina reflection from structures objects a situations Electromagnetic propagation is
71. nment Emissions test Compliance Electromagnetic Environment Guidance RF emissions Group 2 The Model 4XX Series Monitor must emit electromagnetic CISPR 11 energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions Class B The Model 4XX Series Monitor is suitable for use in all CISPR 11 establishments including domestic establishments and those directly connected to the public low voltage power supply Harmonic emissions No connection to mains network that supplies buildings used for domestic purposes IEC 61000 3 2 battery operated Voltage fluctuations flicker No connection to mains emissions battery operated IEC 61000 3 3 a The Model 4XX Series Monitor contains a 5 GHz orthogonal frequency division multiplexing transmitter or a 2 4 GHz frequency hopping spread spectrum transmitter for the purpose of wireless communication The radio is operated according to the requirements of various agencies including FCC 47 CFR 15 247 and R amp TTE Directive 1995 5 EC The transmitter is excluded from the EMC requirements of 60601 1 2 2001 but should be considered when addressing possible interference issues between this and other devices Directions for Use Chapter 7 Compliance 67 Monitor Guidance and Manufacturer s Declaration Electromagnetic Immunity The Model 4XX Series Monitor is intended for use in the electromagnetic environment specified below
72. o 65 bpm 60 bpm expected Rapid Alternating VB 118 to 123 bpm 120 bpm expected Bidirectional Systole 88 to 93 bpm 90 bpm expected Directions for Use Chapter 6 Reference 55 Heart rate and arrhythmia analysis option Method for calculating heart rate Monitor Determined by monitor displayed at monitor Heart rate 60 latest average interval in seconds For higher heart rates latest average interval 7 8 of previous average interval 1 8 of latest interval For lower heart rates latest average interval 3 4 previous average interval 1 4 latest interval Transition rates for choice of formula include hysteresis and are 70 and 80 beats per minute Acuity System with Arrhythmia Option Determined by Acuity Arrhythmia Option software displayed at Acuity Central Station The beat to beat heart rate HR value is calculated as follows HR 60000 actual RR bprn Actual RR time between last detected ORS complex and previously detected ORS complex ms Average HR is calculated on the basis of the mean RR interval in the last 6 seconds or 8 RR intervals whichever is shorter Arrhythmia analysi s option when connected to Acuity ST Analysis ST Analysis can be performed for any or all of seven leads depending on the operator selection The operator can select a measurement offset ST segment shifts are recorded in continuous trend data every second The operator can inspect
73. ority to operate this device outdoors Directions for Use Monitor radio specifications 2 4 Chapter 6 Reference 53 GHz Characteristic Specification FlexNet Network 2 4 GHz Wireless Local Area Network WLAN and 10 100 Base T Ethernet network Frequency 2 402 to 2 480 GHz Modulation Frequency Hopping Spread Spectrum FHSS Output Power 100 mW IEEE 802 11 compliant Yes Monitors per Access Point 15 maximum in most countries In countries where available frequencies are limited this number is reduced a When used within certain countries authorization for use is restricted as follows France The equipment is internally restricted to the 2 448 2 482 GHz frequency range Spain The equipment is internally restricted to the 2 447 2 473 GHz frequency range Japan The equipment is internally restricted to the 2 473 2 495 GHz frequency range Italy Operation requires a user license Note The frequency ranges specified above are subject to geographic specific regulatory authorities ECG specifications The ECG channel meets all the Alarms specified ANSI AAMI E requirements for Cardiac Monitors Heart Rate Meters and C13 1992 except for Impulse response at the monitor section 3 2 9 8 part c and Standardizing Voltage at the monitor and at Acuity section 3 2 9 9 The channel also meets the American National Standard Safe Current Limits for Electromedical Apparatus ANSI AAMI ES1 1993
74. our per axis 3 hours per test Designed to meet RTCA DO 160D Category C Degree of Protection Against Ingress IPX1 Rating Drip Proof per EN60529 1991 Electromagnetic Compatibility EMC EN60601 1 2 2001 A Caution The monitor may not meet performance specifications if it is not used or stored within these environmental specifications 60 Chapter 6 Reference Physical specifications Welch Allyn Micropaq Monitor Protection classifications all configurations Characteristic Specification Type of Protection against Electric Shock Monitor Type CF Battery operation only Battery must be recharged in separate battery charger IEC EN 60601 1 2nd Edition Degree of Protection Against Electric Shock for Parts Applied to Patients See monitor labels CF defibrillator protected IEC EN 60601 1 2nd Edition Recovery time following defibrillator Less than or equal to 10 seconds discharge Method of Disinfection Not suitable for autoclaving see cleaning instructions on Inspect the monitor batteries battery charger and accessories on page 45 Flammable Anesthetics Not suitable for use with flammable anesthetics Height 7 80 in 19 8 cm Width 3 50 in 8 9 cm Depth 1 96 in 4 9 cm Weight including battery Model 406 17 0 oz 0 48 kg Model 408 18 6 oz 0 53 kg Battery specifications Characteristic Specifications Reorder Number Lithium lo
75. pshot key definition will remain as Nurse Call For more information about using the Acuity Central Monitoring System refer to Acuity Directions For Use 4 Scroll Up key and Reset Patient Alarm Tone key Scrolls up menus on the display Resets a silenced patient alarm tone Directions for Use Chapter 1 General information 11 ww Scroll Down key and Main Menu key Scrolls down menus on the display Displays the Main Menu X Select key and Silence Patient Alarm Equipment Alert key Selects the choice highlighted on the menu During patient alarms silences the tone at the monitor and Acuity if connected for 90 seconds During equipment alerts silences or acknowledges dismisses the alert at the monitor and Acuity Battery Insert the battery to turn on power Remove the battery to turn off power While the battery is removed the monitor does not perform patient monitoring Note f you do not use END TELE to disconnect from the network as described above the Acuity Central Station generates a DROPOUT equipment alert at Acuity If you want to monitor this same patient at a later time you will need to reselect the patient name from the monitor or confirm the patient ID at Acuity Recharge the battery while it is removed from the monitor See Recharge a battery on page 43 To order a new battery see Battery Status and Possible Response on page 44 12 Chapter 1 General information Welch Allyn Micropaq Monitor Di
76. r keene e Nenea tedesca i 19 Connecta new Patents 24 eso aos ed aes S DUE C ore S ee 19 Monitor a patient out of range of Acuity llis ese 29 Stopumonitoring a patient sey aes i daret crisi BUE esee rogatus n ite 30 Reconnect a recently monitored patient 2 liiis 31 Reassign a monitored patient to a new room in the same unit 32 Transfer a monitored patient to a new room in a different unit 33 Reassign the monitor to a new patient 2 0 0 eee 34 3 Alarms S alette c eae RE RE a ol C UIDERI OC ote 35 Aboutalarms arid al rts sx daade e EXE Lb ence piani 35 Alarni holdo Ssi iin aene o Ra d e IP eae so BS e du xa 35 Respond to a patient alarm at Monitor 1 eee 36 Customize patient alarm limits at the monitor 0 000 000 0005 37 Respond to an equipment alert at the monitor 0 0 0 0 0008 38 Alert messages and display information 0 0 0 00 eee eee 40 4 Monitor patient at Acuity 0 000 cee ee 41 5 Maintenances cus Se das dorcel EN TX acm pa af eed cen 43 Ghange the batterys c s eee mU P cues a ee INE ES 43 hecharge a battery cce d ety e S ue REIN Eds 43 Inspect the monitor batteries battery charger and accessories 45 Clean the monitor batteries and battery charger n sanasana ananena 45 Glearithexaceessoriles ise etes T DH bbs RADI 46 Re ycling Monitor COMPONENTS sra dug anne ea da a ciae YU V RR eR 47 Change the netwo
77. radiation This device contains an approved RLAN module frequency 2402 to 2480 MHz The monitor is connected to Acuity Flashing The monitor is searching for a connection to Acuity Not magnetic resonance safe Symbol Definition 802 11a Non ionizing electromagnetic radiation This 3 device contains an approved RLAN module 51505825 MHz frequency 5150 to 5825 MHz The monitor is not connected to Acuity FCC ID This device complies with FCC and PGUWA11A07 Industry Canada requirements for IC international radiators 802 11 wireless 4168a WA11A07 Monitor Front Panel Keys Select Key and Silence Patient Alarm Equipment Alert Key Selects the choice highlighted on the menu During patient alarms silences the tone at the monitor and at Acuity if connected for 90 seconds During equipment alerts silences or acknowledges dismisses the alert Scroll Up Key and Reset Alarm Tone Key Snapshot Key When connected to Acuity pressing this key sends Acuity a snapshot print to the Acuity central station printer A total of 21 seconds of patient numeric and waveform data 14 seconds of history 7 seconds after the key is pressed will be sent to the printer See Snapshot key on page 10 for more information afin Scrolls up menus on the display During patient alarms resets the tone at the monitor and at Acuity if connected scroll Down Key and Main Menu Key Pressing wg this key scrolls do
78. re of the pacemaker pulse rejection capability of this instrument WARNING This wireless medical device was tested and when used with a metal free accessory between the monitor and the patient complies with FCC RF Exposure SAR guidelines The use of accessories containing metal may not ensure compliance with FCC RF exposure guidelines Specific Absorption Rate SAR is a measurement of radio frequency energy The FCC permits a maximum SAR value of 1 6 mW g The highest SAR value for this patient monitor when worn by a patient in accordance with the directions for use is 0 560 mW g WARNING Military radars are allocated as primary users in the bandwidths between 5 25 5 35 GHz and 5 47 to 5 725 GHz In the event a radar signature is detected the Access Point moves to a new channel which can temporarily interrupt patient monitoring If the device is operated near a military radar the radar could cause damage to the device WARNING Changes or modifications not expressly approved by Welch Allyn could void the purchaser s authority to operate the equipment This product does not contain any user serviceable components Any unauthorized product changes or modifications will invalidate Welch Allyn s warranty and all applicable regulatory certifications and approvals WARNING Motion artifact can affect the accuracy of patient vital sign measurements Minimize patient motion whenever possible 5 6 Chapter 1 General information Welch Allyn M
79. ries booklet 810 0409 XX e Severe artifact and interference such as defibrillation interference can cause the waveform to move off the display for a few seconds before it is restored Directions for Use Chapter 2 Monitoring 23 Perform 5 Lead ECG monitoring 1 Inspect the ECG cable and replace it if it shows any signs of wear breakage or fraying Plug the cable into the monitor Select electrode sites on the patient Choose flat areas avoid fatty or bony areas and major muscles Shave or clip hair from electrode sites thoroughly clean skin and lightly rub dry You may use soap and water isopropyl alcohol or special skin preparation pads To avoid allergic reactions to electrodes refer to the electrode manufacturer s directions If you are using pre gelled electrodes make sure the electrode date is not expired and the gel is intact and not dried out For best results use only silver silver chloride electrodes If you are using ungelled electrodes apply a 1 4 to 1 2 inch mound of gel over the electrode contact area For best product performance and measurement accuracy do not use stainless steel needle electrodes squeeze bulb electrodes or electrodes with dissimilar metals Due to polarization such electrodes can generate offsets beyond the monitor s capabilities Do not use electrodes from more than one manufacturer on the same patient Attach lead wires to the electrodes before applying them to the patient App
80. rk names s est RO RED LEE Aes UD 48 iv Contents Welch Allyn Micropaq Monitor OS Heferenceaessceua tat Oh tk eir ori E E D uU de Beat 51 Operating setings sans score eae UD SEI E cM UAE SESS PES IS 51 SDGGIIICatIOL8 44 esos ol Diss a Pos Dhu dr al Naa D dest a dee ot oe en 52 Z Compliance seresa a uote Tta Pad dote ed ed d eq ees 63 El General information Intended use The Micropag monitor is intended to be used by clinicians for single or multiparameter vital signs monitoring of ambulatory and nonambulatory pediatric and adult patients in health care facilities The monitor is able to withstand light rain exposure over short periods of time uniform distribution of approximately 1 mm of water per minute for 10 minutes or less The Micropag monitor is intended to operate with an Acuity Central Monitoring System through wireless communication over the Welch Allyn9 FlexNet network FlexNet connects multiple devices to the Acuity Central Monitoring System through hardwired Ethernet networks and Wireless Local Area Networks WLANs If the Micropag monitor is moved out of range or loses communication with the FlexNet network it continues to monitor the patient display patient data and generate local patient alarms or alert messages e The ECG channel is intended primarily for five lead ECG monitoring although three lead ECG monitoring is supported e The Pulse Oximetry channel is intended for continuous noninvasive monitoring o
81. s connected See Heart rate and arrhythmia analysis option on page 55 and Pulse oximetry SpO specifications Nellcor on page 57 52 Chapter 6 Reference Specifications Monitor radio specifications 5 GHz Welch Allyn Micropaq Monitor Characteristic Specification FlexNet Network 5 GHz orthogonal frequency division multiplexing OFDM wireless local area network WLAN and 10 100 1000 base T Ethernet network Modulation OFDM Output power 40 mW maximum country dependent IEEE standards 802 11a 802 11e 802 11h 802 1X Monitors per access point 20 max Caution Some countries restrict the use of 5 GHz bandwidths The 802 11a radio A in the Micropaq monitor uses only the channels indicated by the access point with which the radio associates The hospital IT department must therefore configure all associated access points to operate within approved domains Channel restrictions in the 5 GHz band by country are as follows Restrictions for use in the 5 GHz bands Allowed frequency bands Allowed channel numbers Countries 5 15 to 5 25 GHz 36 40 44 48 Austria 5 15 to 5 35 GHz 36 40 44 48 52 56 60 64 Cyprus Czech Republic France Hungary Slovakia 5 15 to 5 35 GHz 36 40 44 48 52 56 60 64 100 Belgium Bulgaria Denmark and 5 470 to 5 725 GHz 104 108 112 116 120 124 128 Estonia Finland Germany Greece 132 136 140 Iceland Ireland Italyd Latvia
82. sage and error number Report such errors to Welch Allyn The monitor should be serviced only by a Welch Allyn service technician while under warranty Contact Welch Allyn for information about post warranty period service Directions for Use Chapter 1 General information 7 Introducing the monitor The monitor is a patient worn vital signs monitor for use by adult or pediatric ambulatory patients Model 406 Model 408 One or two ECG channels displayed uu E Up to 2 ECG leads displayed at the monitor I II H V aVg aV or aVe with 5 lead cable Up to 7 ECG leads displayed at Acuity I Il TII V aVp aV or aVe with 5 lead cable One ECG lead displayed at the monitor and at Acuity Fixed lead II with 3 lead cable or 5 lead cable with only RA LA and LL electrodes attached Pulse oximetry SpO5 monitoring Model 408 only Two way wireless communication within Welch Allyn s FlexNet network LCD for display of ECG waveforms SpO and heart rate pulse rate data and messages from Acuity Standalone operation with patient alarms when out of range of the network Patient alarm limits that can be set at the monitor or at Acuity Configurable formats for single or dual waveform ECG display Internal antenna Snapshot key Lightweight less than two pounds with battery Rugged and tolerant of brief water exposure Rechargeable battery Sleep mode to extend battery life Your model may be shipped with an attac
83. splay Although the Acuity Central Station is the primary location for viewing patient data the monitor provides information to support patient care Dashed lines indicate the Patient name as entered at monitor detects a pacemaker Acuity Waveform scale is signal display of pacer If the patient selectable detection can be enabled or haare orb ihe monitor disabled at Acuity displays the last four digits of ECG lead is selectable the monitor serial number such as ID 6472 HR indicates the heart rate is from ECG PR pulse rate is displayed if SpO is active l and ECG is not pulse rate monitor whenever the is derived from SpO Snapshot key is pressed If the monitor detects g a vital sign outside ee the measurable range d M is displayed it displays 9 X 5 when active below the range Sp0 numeric data is a above the range Q percentage value Indicates the monitor Low battery icon flashes to Symbol is displayed at the is connected to indicate monitor will shut off in Acuity Indicates one or 30 minutes or less more patient alarms This symbol indicates the monitor is not Sp0 pulse amplitude indicator communicating with Acuity are disabled off not proportional to pulse Flashing indicates the monitor is associated volume with an access point but not communicating with Acuity Continuous on indicates the monitor is not communicating with an access point or A
84. ssage ACUITY CONNECTION LOST Depending on how the monitor is configured as controlled by Acuity this alert can also cause the monitor to emit audible alert tones If tones are enabled the authorized person should press Y on the monitor to acknowledge dismiss the alert and silence this instance of the alert tone Note The person authorized to press Y to acknowledge the alert may vary depending on the local protocol Follow the protocol established by your institution When the patient returns within range of Acuity the monitor automatically reconnects to Acuity No clinician intervention is required WARNING When the monitor moves out of range of the Acuity network A communication with Acuity is broken immediately stopping the communication of patient vital signs data If the monitor is out of range of the Acuity network for several minutes the radio enters a low power state When the monitor is again within range of the Acuity network it can take as long as three minutes to restore communication with Acuity and resume the communication of patient vital signs data 30 Chapter 2 Monitoring Welch Allyn Micropaq Monitor Stop monitoring a patient If you want to discontinue monitoring the patient follow these steps 1 Press gg to display the Main Menu 2 Press v to highlight ACUITY then press x II invicn HR Spo BPH 80 9 a 37 EXIT ACUITY END TELE MENU NEH ROOM TRANSFER 7 Acuity Menu
85. tient alarm Patient alarms are silenced An equipment alert or not connected to the network Equipment alert suspended for 90 seconds at Acuity or low battery alert acknowledged dismissed Audio Tone Locations Monitor Acuity Central Station when connected Audio Tone Frequency 2900 Hz Life Threatening Arrhythmia Alarm Tone Pattern Patient Alarm Tone Pattern Equipment Alert Tone Pattern 1 second on 1 second off 1second on 2 seconds off 1second on 4 seconds off Audio Tone Volume The monitor audio tone volume is configured by the Acuity System to High Low or Off The monitor can be configured with separate audio tone volume settings for when it is connected to an Acuity System and when it is not Limits Setable on all parameters Alarm Control Automatic preset or manual settings Alarm Priority Highest priority Patient alarms Lowest priority Equipment alerts Alarm on Tachycardias Most tachycardias will alarm in less than 8 seconds These include AAMI 3 1 2 1 part f waveforms Certain multifocal tachycardias may initially alarm as low rate Alarm Holdoff Time Period HR 3 seconds 96 SpO PR 10 seconds Acuity Configurable Audio Alarm Delay at the monitor When a monitor is connected to an Acuity System the audio alarms at the monitor can be delayed up to 4 minutes and 15 seconds The delay time is selected in Acuity software at the time of Acuity installation
86. tion To perform ECG monitoring see Perform ECG monitoring on page 21 To perform SpO monitoring see Perform SpO2 monitoring on page 26 32 Chapter 2 Monitoring Welch Allyn Micropaq Monitor Reassign a monitored patient to a new room in the same unit If a patient is being monitored and you want to assign them to a new room in the same unit follow these steps 1 Press wr to display the Main Menu 2 Press www again to highlight ACUITY and press X to display the Acuity Menu Screen 3 Press ww to highlight NEW ROOM then press X T 77 8o BPH 80 9 a 37 XIT ACUITY ND TELE MENU RANSFER x New Room Selection Within a few seconds the monitor displays a list of all available rooms including the patient s current room e f you decide not to change the patient s current room assignment press X the patient s current room is the default selection in the list e To assign the patient to a new room highlight the room and press X e f you want to cancel the patient s current room assignment but do not want to assign a new room at this time you can highlight Select Room at Central and press Y You can then assign the room later from the Acuity Central Station or you can repeat this procedure and assign a new room from the monitor Directions for Use Chapter 2 Monitoring 33 Transfer a monitored patient to a new room in a different unit If a patient is being monitored and you want to assig
87. tions For Use Battery ECG electrodes 3 lead ECG cable optional 5 lead ECG cable ECG extension cable optional Carrying pouch SpO sensors Masimo or Nellcor SpO cable Masimo or Nellcor WARNING Use only accessories supplied by Welch Allyn or recommended in A the Welch Allyn Products and Accessories booklet 810 0409 XX The monitor will only meet the listed specifications when using accessories listed by Welch Allyn Use accessories according to your facility s standards and the manufacturer s recommendations Always refer to the manufacturer s Directions for Use Operating settings The following monitor operating settings can be set at the monitor or at the Acuity Central Station e Patient alarm limit settings ECG and SpOJ e ECG lead and scale selection e ECG display format Many other monitor operating settings such as patient mode and alarms volume can only be set at the Acuity Central Station See Operating settings on page 51 for a list of all settings and where they are set Default settings When the monitor connects to Acuity for a new patient the Acuity Central Station downloads the appropriate default settings stored at Acuity While the monitor is connected to Acuity settings can be changed either at the monitor or at the Acuity Central Station If the monitor is temporarily disconnected from Acuity and the operator changes settings at the monitor those settings are transmitted to and stored at Acuity whe
88. toring you must disconnect the ECG cable from the monitor for a few seconds and then begin this procedure again Directions for Use Chapter 2 Monitoring 25 Be aware that only ECG lead II is available for display with the monitor s 3 lead ECG monitoring No other ECG lead selections are available WARNING Do not try to perform this 3 lead ECG monitoring with any 5 lead ECG cable that does not have detachable electrode lead wires as described above Attempting to perform this procedure with a 5 lead ECG cable which has lead wires cut off or hanging loose and not connected to the patient would present a shock hazard to the patient or clinician 3 Lead ECG application with the 3 Lead ECG cable Note Be aware there are some inherent limitations with this application especially when compared to 5 lead ECG monitoring These limitations include the restriction to only one displayed lead ECG II lead Because only one displayed lead is available ECG lead II factors such as poor electrode connection at RA LA or LL can significantly affect performance To overcome these limitations the 5 lead ECG monitoring is preferred The monitor s 3 lead ECG monitoring is only available for use with Acuity software versions 6 1 or later Refer to the Welch Allyn Product and Accessories booklet 810 0409 XX for part numbers Follow these steps 1 2 3 Perform Step 1 through Step 4 on page 23 as described for 5 lead ECG monitoring Attac
89. trend data to see the duration and elevation or depression for each episode for any time period recorded The operator can also inspect a summary of ST segment shift data within tabular trends Heart Rate Heart rate information is available in the trend data which can be viewed on the display or printed The operator can inspect the trend data to see the lowest highest and median averaged heart rates Trend data also includes the total beats per range of time Definition of Pause Arrhythmia Event A pause is defined as the R R interval which is greater than or equal to two times the average R R Chapter 6 Reference Welch Allyn Micropaq Monitor Pulse oximetry Sp0 specifications Masimo SpO2 complies with EN ISO 9919 2005 Characteristic Specification Saturation 96 SpO Range Resolution Alarm Limits With Acuity 6 0 or higher With Acuity 5 4X or lower 196 to 10096 196 5096 to 9996 lower 5196 to 10096 upper 80 to 9996 lower 81 to 100 upper Probe Accuracy Adults Pediatrics No Motion During Motion 70 to 100 2 counts 0 to 69 unspecified 70 to 100 3 counts 0 to 69 unspecified Pulse Rate Range Resolution Alarm Limits 26 to 239 beats per minute 1 beat per minute 25 to 245 beats per minute lower 30 to 250 beats per minute upper Pulse Rate Accuracy No Motion During Motion 3 beats per minute 5 beats per minute Display Update Int
90. ty Compatible only with Nellcor sensors listed in the Micropaq monitor section of the Welch Allyn Products and Accessories booklet 810 0409 XX For probe sensor compliance to EN ISO 9919 2005 see the Nellcor directions for use Sensor LED Wavelengths Within 500 to 1 000 nm Sensor Energies Radiant Power Does not exceed 15 mW a b Sp0 alarm limit range depends on the software version of the Acuity System to which the monitor is connected Although some of the listed Nellcor sensors can be used with neonates with other pulse oximetry devices the monitor is only intended for use with adult and pediatric patients not with neonates WARNING A Interfering Substances Carboxyhemoglobin may erroneously increase readings The level of increase is approximately equal to the amount of carboxyhemoglobin present Dyes or any substances containing dyes that change usual arterial pigmentation may cause erroneous readings WARNING Although the SpO alarm limit range can be adjusted down to 50 saturation with Acuity 6 0 software or higher the SpOs performance and accuracy is not specified below 70 58 Chapter 6 Reference Welch Allyn Micropaq Monitor Patient alarm and equipment alert specifications Characteristic Specification Visual Alarm Indicator at the monitor Flashing GREEN LED Flashing RED LED Continuously ON RED LED Flashing YELLOW LED Continuously ON YELLOW LED Normal operation Pa
91. ues to display this message until Acuity responds or you press X to acknowledge the message and clear the screen If the monitor detects an alarm or alert it clears the screen to display the appropriate alarm or alert message The length of time required for Acuity to respond to your selection at the monitor can vary widely depending on the amount of network traffic and other conditions Access a menu to change the ECG 1 or ECG 2 lead selection I II Ill aVg aV aVg or V Available vectors depend on the connected electrodes 14 Chapter 1 General information ECG SCALE 1 WAVEFORM LIMITS SYSTEM INFORMATION SERVICE MENU Welch Allyn Micropaq Monitor Change the scale of the ECG waveform If two waveforms are displayed both have the same scale There are four possible ECG waveform display selections 1 WAVEFORM the default selection 2 WAVEFORMS 5 SECONDS FULL SCREEN Pressing y changes to the next selection This change does not take effect until after you exit the Main Menu See Display on page 12 for descriptions Enter the Alarm Limits Menu Customize patient alarm limits at the monitor on page 37 and change alarm limits Display information about the network connection and SpOs module Enter Service Mode for a demonstration mode Demo see Demonstration mode on page 17 or service functions for technicians Service Mode is not available if any cables are plugged in Note To restri
92. ut MR safety precautions Failure to follow these precautions creates a risk that the magnetic field will damage the monitor causing it to overheat and potentially burn patents and cause a fire The damage to the monitor caused by exposure to magnetic fields may be immediate or latent If the damage is latent it can cause the monitor to overheat at some time subsequent to its exposure to the magnetic field WARNING Electronic equipment that emits strong electromagnetic or radio frequency signals can cause electrical interference with monitor operation This interference may distort the ECG signal thereby preventing accurate rhythm analysis Avoid operating this device near equipment of this type WARNING Exposure to Radio Frequency RF radiation To comply with Federal Communications Commission FCC RF exposure requirements this device shall be used in accordance with the operating conditions and instructions provided in this manual including the section Install the carrying pouch on page 28 WARNING Pacemaker signals can differ from one pacemaker to the next The Association for Advancement of Medical Instrumentation AAMI cautions that in some devices rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias Do not rely entirely upon rate meter alarms All pacemaker patients should be kept under close or constant observation See ECG specifications on page 53 for disclosu
93. ve completed all changes scroll to PREVIOUS MENU then EXIT on the Alarm Limits Adjust Menu and press v to return to the normal monitoring screen Note X While the monitor is connected to Acuity settings can be changed either at the monitor or at Acuity Respond to an equipment alert at the monitor When the network or the monitor detects an equipment problem the monitor produces a an audible alert tone if audible tones are enabled Equipment alerts beep at a slower pace than patient vital sign alarms see Patient alarm and equipment alert specifications on page 58 The monitor also displays a flashing yellow light LED and an equipment alert message similar to the following John Smith bs eae BPM 9 LX Z m SRCH The monitor has detected that the ECG cable has been EQUI PMENT ALERT disconnected from the NO ECG CABLE DETECTED monitor PRESS KEY TO ACKNOWLEDGE 1 In this instance press Y to acknowledge dismiss the alert tone and clear the message If the message says PRESS ZY TO SILENCE when you press X the tone is silenced for 90 seconds instead of dismissed If the monitor displays a chest diagram with a missing lead flashing you can press x to silence the tone Some alerts do not give you the option to acknowledge the alert or silence the tone For these alerts to remove the message and tone you must correct the problem Directions for Use Chapter 3 Alarms amp alerts 39
94. vendors For information about any Welch Allyn product please call Welch Allyn Technical Support USA 1315 685 4560 Australia 61 2 9638 3000 800 535 6663 800 074 793 Canada 800 561 8797 China 86 216 327 9631 European Call 35 3 46 906 7790 France 33 1 60 09 33 66 Center Germany 49 7477 92 71 86 Japan 81 3 3219 0071 Latin America 1 305 669 9003 Netherlands 31 15 750 5000 Singapore 65 6419 8100 South Africa 27 11 777 7555 United Kingdom 44 20 7365 6780 Sweden 46 8 58 53 65 51 REF 103512 CD Manual Part Number 80015977 Ver A 2010 03 EC REP Welch Allyn Ltd Welch Allyn Protocol Inc Navan Business Park 8500 SW Creekside Place Dublin Road Navan Beaverton OR 97008 7107 USA County Meath Republic of Ireland www welchallyn com C oss Welch Allyn Contents 1 General information xs x wsok i et eri el ea e eC oe eae ake 1 Fit ridedilse aria eu Pepe ten tha LS Lot NH Lover Ru s UR t 1 General warnings and cautions aanas aaau aaaeeeaa 4 Introducing theTrioBHtor x uu sd oe pot Rae dh Reden ep RR dee det Soh eed 7 Understanding the monitor and the FlexNet Network 00 8 Monitor feature Sroa Coe e vo ee p d c D e ede PEG 9 ACCESSORIES re Tinten d e eret tede LARA Rocca t POE uncalled mri A cc aan UA TR am 16 Operating SettingS lt eso 5 2k oes atu E Eie ies is 16 Demonstration mode a unos eer RUP IRR IR UR ROUES e E ae 17 2 MODBItOEIE ve iu ace mires odo
95. warning about an equipment condition that needs attention such as a low battery or detached ECG lead Alarms and alerts may be detected either by the monitor or by the network While connected to the network alarms or alerts are displayed at the monitor and at the Acuity Central Station Alarms have a higher priority than alerts Alarm holdoffs To help minimize false alarms the monitor briefly delays or holds off triggering alarms for limit violations for HR PR or SpO After the alarm holdoff period begins if the monitor detects that the patient s vital sign has returned to acceptable limits the monitor cancels the alarm holdoff The next time a vital sign limit is violated the monitor starts a new holdoff period Vital Sign Alarm Holdoff Period HR 3 seconds SpO or PR 10 seconds 36 Chapter 3 Alarms amp alerts Welch Allyn Micropaq Monitor Respond to a patient alarm at monitor When a patient alarm occurs the monitor produces an audible tone if audible tones are enabled Life threatening arrhythmia alarms beep at a faster pace than other vital sign alarms see Patient alarm and equipment alert specifications on page 58 The monitor also displays a message similar to the following Red LED flashes v Sp during alarm EY After the alarm is silenced or suspended at Acuity the red i EE 9 1 LED is on d continuously PATIENT ALARM PRESS 4 KEY TO SILENCE
96. wn menus on the display or causes the Main Menu to appear if no menu is displayed 4 Chapter 1 General information Welch Allyn Micropag Monitor Battery charger labels and LEDs Eight bay battery charger 008 0651 XX Green LED on continuously O p Battery is fully charged Green LED flashing V4 amp Battery is charging Green LED flashing very slowly C Battery detected and waiting to be charged I Yellow LED on continuously Something is wrong with the battery or the O a IN charger See Battery Status and Possible Response on page 44 General warnings and cautions Familiarize yourself with all warnings and cautions before using the monitor A WARNING When considering a treatment protocol that involves wireless communication of patient data be sure to recognize some limitations inherent in wireless communications When the monitor is not connected to the network e There are no patient alarms or alerts at the Acuity Central Station e Acuity does not perform arrhythmia and ST analysis on the patient data and does not generate related alarms e Patient data is not saved WARNING Do not try to monitor neonatal patients with the monitor The monitor is intended for adult or pediatric patients It is not intended for use with pediatric patients or infants weighing less than 22 lbs 10 kg WARNING Always check the patient mode at Acuity when monitoring a new patient The patient mode
97. y 12 Snapshot Key 10 Specifications 52 Alarms 58 Battery 60 Battery charger 61 Display 59 Environmental 59 Physical 60 Sp02 56 Sp02 Alarm holdoff delay 35 Anemia 27 Arterial occlusion 27 Cardiac arrest or shock 27 Hypotension 27 Hypothermia 27 Light interference 27 Monitoring 26 Monitoring and defibrillation 26 Motion interference 27 Specifications 56 Vasoconstriction 27 Welch Allyn Micropaq Monitor Warnings 26 While monitoring NIBP 27 Stop monitoring a patient 30 Symbols display 12 System error 40 T Training see Demo Mode TRANSFER 13 33 Transfer a patient to new room 33 U Unassigned rooms 21 UNRECOGNIZED SPO2 SENSOR 40 V Vasoconstriction and SpO2 27 Venous pulsations and Sp02 26 VERY LOW BATTERY message 40 Volume of audible indicators 10 W Warnings General 4 Sp02 26 Warranty service 6 Waveform display options 15 Wireless Warnings about limitations 4 Wireless Local Area Network see WLAN WLAN 1 8 Y Yellow LED 10
98. y When the patient name and ID are confirmed at Acuity Acuity downloads the default settings and patient alarm limits for that Acuity unit thereby overriding any custom alarm limits that were set at the monitor before selecting the patient 1 Press wr to display the Main Menu 2 Press ww to highlight LIMITS then press Y to display the Alarm Limits Adjust Menu I inv BPH 80 p HR PR LO HR PR BPH HR PR HI Sp 2 Fa 5p02 LO 7 Jahn Smith ve as LOHER UPPER 5D 120 30 100 ADULT MODE Alarm limits can be adjusted for HR PR and SpO 3 To change an alarm limit press ww or to highlight the desired limit then press X to display the Threshold Adjustment Menu HR Sp 2 j BPH 80 9 zE 37 LOMER UPPER ON OFF HR PR BPH so E Spoz x 30 100 A ADULT MODE Select or to change the limit Scroll and select the or selections to change the limit as desired To turn the highlighted limit on or off scroll to ON OFF and press X 38 Chapter 3 Alarms amp alerts Welch Allyn Micropaq Monitor WARNING f you turn off any alarm limits be sure to restore the appropriate alarm limits before you resume monitoring Only life threatening arrhythmias will be indicated at the monitor and Acuity if connected when alarms are turned off To change other limits scroll to PREVIOUS MENU press then select another limit to change When you ha

Welch Allyn Medical Diagnostic Equipment Computer Monitor 406 User's Manual

Contents

Download Pdf Manuals

Related Search

Related Contents