Welch Allyn WA11A07 Welch Allyn 802.11a Wireless PC Card User Manual Micropaq Monitor Directions for Use
Welch Allyn, Inc. Welch Allyn 802.11a Wireless PC Card Micropaq Monitor Directions for Use
Contents
- 1. User Manual part 1 of 2
- 2. User Manual part 2 of 2
User Manual part 2 of 2
35 Alarms & alerts About alarms and alerts Alarms provide a warning about a patient condition (such as a vital sign limit violation). Alerts provide a 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 SpO2. 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 % SpO2 or PR 10 seconds 36 Chapter 3 Alarms & 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 56). The monitor also displays a message similar to the following: Red LED flashes during alarm. After the alarm is silenced (or suspended at Acuity), the red LED is on continuously. 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 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 If you 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 Directions for Use Chapter 3 Alarms & alerts 37 3. To reset the alarm tone at the monitor and Acuity before the 90 seconds has elapsed, press 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 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 Acuity. 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 2. Press Menu: to display the Main Menu. to highlight LIMITS, then press to display the Alarm Limits Adjust Alarm limits can be adjusted for HR/PR and SpO2. 3. To change an alarm limit, press or to highlight the desired limit, then press to display the Threshold Adjustment Menu: 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 38 Chapter 3 Alarms & alerts Welch Allyn Micropaq Monitor WARNING If 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. 4. To change other limits, scroll to PREVIOUS MENU, press limit to change. , then select another 5. When you have completed all changes, scroll to PREVIOUS MENU, then EXIT on the Alarm Limits Adjust Menu and press to return to the normal monitoring screen. Note 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 56). The monitor also displays a flashing yellow light (LED) and an equipment alert message similar to the following: The monitor has detected that the ECG cable has been disconnected from the monitor. 1. In this instance, press message. to acknowledge (dismiss) the alert tone and clear the If the message says “PRESS TO SILENCE,” when you press silenced for 90 seconds instead of dismissed. , the tone is If the monitor displays a chest diagram with a missing lead flashing, you can press 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 & alerts 39 2. If possible, determine what caused the problem and correct it. Note After you press 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 & 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. • 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. • 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. • Replace the battery immediately. ACUITY CONNECTION LOST The monitor is not connected to the network. • Press 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 ELECTRODESa The monitor detects poor ECG electrode contact. • Check and replace ECG electrodes as needed. Chest icon is displayed with flashing ECG electrode(s).a The monitor detects that one or more ECG electrodes are disconnected. • Check and replace or reconnect electrodes as needed. NO ECG CABLE DETECTED • If the ECG cable has been intentionally removed from the monitor, press to cancel the alert tone. • If 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. • It 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 SpO2 sensor has been disconnected for more than 5 seconds. • If disconnection is intentional, press to acknowledge and silence the tone. • If disconnection is not intentional, reconnect the sensor or replace the sensor and reconnect. The SpO2 sensor is either defective or not recognized. DEFECTIVE SPO2 SENSORa • Replace the SpO2 sensor with a new, compatible SpO2 sensor. or UNRECOGNIZED SPO2 SENSORaKEY STUCKa During the power-up self test, the monitor detected that a key is stuck ( , or ). This can happen if you accidentally press a key down before the Main Menu is displayed during power-up. • Remove and then reinsert the battery to power up again and see if the key is still stuck. If it is, contact your biomedical engineering department. System Error Thread: Error ID: The equipment problem is so serious the monitor cannot be used. • Contact your biomedical engineering department. a. This alert message can be acknowledged from Acuity, but not from the monitor. 41 Monitor patient at Acuity While the Micropaq 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: • 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 For more information about using the Acuity Central Workstation, refer to: • Acuity Directions For Use 42 Chapter 4 Monitor patient at Acuity Welch Allyn Micropaq Monitor 43 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 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 Micropaq Monitor If the 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 Label—LEDs Battery Status and Possible Response Green LED on continuously Battery is fully charged. Green LED flashing Battery is charging. Green LED flashing very slowly Battery is detected and waiting to be charged. LED off No battery is detected. Yellow LED on continuously Something is wrong with the battery or the charger. Remove the battery. • 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. • If the 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 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 Ion. 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 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 and clean the monitor and accessories WARNING Be sure to unplug the monitor battery charger power cord from the electrical power outlet before inspecting or cleaning the battery charger. Exposing the battery charger to liquids such as cleaning solutions while connected to electrical power could result in electrical shock or fire. WARNING Do not autoclave the monitor, battery, battery charger, or accessories. Do not immerse the monitor, battery, or battery charger in liquid when cleaning. Do not immerse accessories in liquid when cleaning unless the accessory manufacturer’s cleaning instructions explicitly instruct you to do so. Before cleaning, thoroughly inspect the monitor and all accessories for any signs of damage, cracks, or improper mechanical function of keys or connectors. While gently bending and flexing cables, inspect for damage, cracks, cuts, abrasions, extreme wear, exposed wires or bent connectors. Confirm connectors securely engage. 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. To clean the monitor, batteries, or battery charger: 1. Wipe the equipment with a nearly dry cloth moistened with one of the approved cleaning solutions listed in the table on “Approved Cleaning Solutions” on page 46. 2. After cleaning, thoroughly wipe off any excess cleaning solution with a soft cloth dampened with water, then dry. Do not let the cleaning solution run into or accumulate in connector openings, latches, or crevices. If liquid gets into a battery well or connectors, dry the area with warm air, then check the equipment to confirm that it operates properly. Caution Use only cleaning solutions which are recommended by Welch Allyn for this equipment. Use of solutions which are not recommended or which 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: Butyl alcohol, Denatured ethanol, Freon™, Mild chlorine bleach solution, Isopropyl alcohol (except for the SpO2 cable), Trichloroethane, Trichloroethylene, Acetone, Vesphene II, Enviroquat®, Staphene®, Misty®, Virex®, Glutaraldehyde, Formula 409®, or Fantastik®. 46 Chapter 5 Maintenance Welch Allyn Micropaq Monitor Equipment Cleaning Instructions Approved Cleaning Solutions Monitora Batterya Battery Chargersa • Wipe with a nearly-dry cloth moistened with cleaning solution. • After cleaning, remove excess cleaning solution with a soft cloth dampened with clean water, then dry. Do not let cleaning solution run into connector openings or crevices.b Warm water, Liquid soap, Coverage®, Windex®, Ovation®, Hydrogen peroxide solution, Wex-cide®c, T.B.Q.®c ECG cable, extension cable • Wipe gently with damp cloth moistened with a mild detergent solution. • Thoroughly wipe off any cleaning solution. Mild detergent. SpO2 cable, extension cable • Wipe the cable with a 70% isopropyl alcohol pad and allow it to dry. 70% isopropyl alcohol pad. Other accessories • Consult manufacturer’s instructions. Consult manufacturer’s instructions. a. b. c. The equipment may be disinfected to comply with OSHA requirements for cleaning and decontaminating spills of blood and other body fluids. (Federal OSHA Standard on bloodborne pathogens: 29 CFR 1910.1030, 12/6/91.) If liquid gets into the battery well or connectors, dry the area with warm air, then check the monitoring functions for proper operation. Wex-cide (Wexford Labs, Inc., Kirkwood, MO) and T.B.Q. (Calgon Vestal Lab., Calgon Corp., St. Louis, MO) are disinfectants that meet OSHA requirements, are EPA approved, and will not harm the outside of the monitor, battery, or battery charger. Wipe away disinfectants with a water-dampened cloth after the manufacturer’s recommended period. 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 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. Li++ Recycle monitor batteries (Li++) according to the Directive 91/157/EEC (Batteries and accumulators containing certain dangerous substances) and Directive 93/86/EEC (Labelling of batteries and accumulators containing certain dangerous substances). Directions for Use Chapter 5 Maintenance 47 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). Note Changing the monitor network name will cause the monitor to re-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. To change the network name: 1. Press to access the Main Menu, then repeatedly press is highlighted. 2. Press until SERVICE MENU to display the Service Menu screen. 3. Press and hold and , then press to display the Network Name Menu. If the current monitor network name is one of the following pre-set names: com.protocol demo.protocol com1.protocol com2.protocol com3.protocol com4.protocol com5.protocol com6.protocol com7.protocol com8.protocol then the monitor displays the following screen 48 Chapter 5 Maintenance Welch Allyn Micropaq Monitor To change the network name, make sure YES is highlighted, then press the following screen: to display Press or to highlight the desired network name, then press . 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: You cannot change the network name using the Network Name Menu. Press to return to the Service Menu. Contact Welch Allyn Technical Support for assistance. 49 Reference Operating settings The following table lists all of the monitor settings and the default settings. Monitor Default Setting No Previous Setting Retained at Monitor at Power-Up Yes No Yes Yes Single Yes Yes Yes No No Yes Yes No No No Yes Yes No Yes Yes Yes Yes Yes Yes Yes II V (or III if no V lead) 1 mV/cm English 60 No No No No Yes Yes No Yes off high No No Yes No No Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes No No Yes Yes off low Adult: 50, 120 bpm Ped: 50, 150 bpm Adult: 90, 100% Ped: 90, 100% U.S. No No No Yes No No No Yes Yes Yes No Yes On Off 120 seconds Parameter Set at Monitor Set at Acuity For Each For Entire Patient a Acuity Unitb Patient Mode 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 Sec, or Full Screen) ECG 1 Lead Selection ECG 2 Lead Selection ECG Size (Scale) Language Mains Filter (off, 50, or 60 Hz) Vital Signs Alarm Volume (high, low, or off) With Acuity Connection Without Acuity Connection Equipment Alert Volume (high, low, or off) With Acuity Connection Without Acuity Connection HR/PR Alarm Limits (Lower, Upper) SpO2 Alarm Limitsc (Lower, Upper) Regulatory settings (U.S., Europe, Japan) Pacer Detection Enable Menu Lockout Display Backlight Timeout No Yes Yes a. b. c. Adult Set by clinician at Acuity Central Station. Set by Acuity System Administrator during system installation. SpO2 alarm limit range depends on the software version of the Acuity System to which the monitor is connected. (See “Heart rate and arrhythmia analysis option” on page 53 and “Pulse oximetry (SpO2) specifications - Nellcor” on page 55.) 50 Chapter 6 Reference Welch Allyn Micropaq Monitor Specifications Monitor radio specifications (5 GHz) Characteristic FlexNet™ Network Modulation Output power IEEE standards Monitors per access point Specification 5 GHz orthogonal frequency division multiplexing (OFDM) wireless local area network (WLAN) and 10/100/1000 base-T Ethernet network OFDM 40 mW maximum; country-dependent 802.11a, 802.11e, 802.11h, 802.1X 20 (max.) Restrictions for use in the 5 GHz bandsa Allowed frequency bandsb Allowed channel numbersc 5.15 to 5.25 GHz 36, 40, 44, 48 5.15 to 5.35 GHz 36, 40, 44, 48, 52, 56, 60, 64 5.15 to 5.35 GHz and 5.470 to 5.725 GHz a. b. c. d. Countries Austria Cyprus, Czech Republic, France, Hungary, Slovakia 36, 40, 44, 48, 52, 56, 60, 64, 100, Belgium, Bulgaria, Denmark, 104, 108, 112, 116, 120, 124, 128, Estonia, Finland, Germany, Greece, 132, 136, 140 Iceland, Ireland, Italyd, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, Switzerland, U.K. 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). 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. 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. In Italy the end-user must apply for a license from the national spectrum authority to operate this device outdoors. Monitor radio specifications (2.4 GHz) Characteristic FlexNet Network Frequencya Modulation Output Power IEEE 802.11 compliant Monitors per Access Point a. Specification 2.4 GHz Wireless Local Area Network (WLAN) and 10/100 Base-T Ethernet network 2.402 to 2.480 GHz Frequency Hopping Spread Spectrum (FHSS) 100 mW Yes 15 (maximum) in most countries. In countries where available frequencies are limited, this number is reduced. 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. Directions for Use Chapter 6 Reference 51 ECG specifications The ECG channel meets all the requirements for Cardiac Monitors Heart Rate Meters and Alarms specified ANSI/AAMI EC13-1992, 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). Characteristic Connector Selectable Leads 5-Lead Cable 3-Lead Application (using 3-lead ECG cable, or 5-lead ECG cable with detachable lead wires; only RA, LA, LL electrodes connected) Lead Fault Indicator ECG Size (sensitivity) Display Sweep Speed Bandwidth Local display To Acuity Central Station Sample Rate Input Protection Electrosurgery interference suppression Lead Fail Sense Current Tall T-wave Rejection Specification Hypertronics D01 latching connector Monitored: II, III, V; Derived: I, aVR, aVL, aVF Monitored: II Displayed chest icon with flashing indicator for each electrode 0.2, 0.5, 1, 2, 4, and 8 mV/cm 25 mm/sec 0.5 to 94 Hz independent of patient mode 0.05 to 94 Hz independent of patient mode 364 Hz (182 Hz with turning point decimation to Acuity Central Station) Electrosurgery and defibrillator protected when used with ECG cables specified in the Welch Allyn Products and Accessories booklet (810-0409XX). Included on all vectors. 70 nA dc typical for active leads. 140-280 nA dc typical for reference electrode, depending on number of electrodes attached. Meets AAMI (USA) EC13-1992, section 3.1.2.1.c, up through 1.2 mV 52 Chapter 6 Reference Characteristic Common Mode Rejection FILTER function OFF FILTER function ON Input Impedance Input Range (ac) Welch Allyn Micropaq Monitor Specification <1 mV p-p RTI for 10V rms, 50/60 Hz into unbalanced input <30 µV p-p RTI for 10V rms, 50/60 Hz into unbalanced input >2.5 M¾ differential @ 60 Hz 10 mV peak to peak (local display) 10 mV peak to peak (Acuity Central Station) Input Range (dc) Up to ±500 mV System Noise ð30 µV peak-to-peak, RTI QRS 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 25 to 350 beats per minute (measurement) 25 to 300 beats per minute (display) 25 to 245 beats per minute (lower) Alarm Limits 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 Indicates rate of 30 to 46 during AAMI EC13-1992 part 3.1.4.1 part (f) and (g) paced QRS pattern tests. NOTE: AAMI Test 4.1.4 part f and g: Accuracy is affected (i.e., rate increases) when QRS 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 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- 80 beats per minute indicated for 80 beats per minute ECG plus drift 1992, 3.2.6.3) 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 to 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 53 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 Determined by Acuity Arrhythmia Option software (displayed at Acuity Central Station) Arrhythmia Option The beat-to-beat heart rate (HR) value is calculated as follows: HR = 60000/actual RR (bpm). Actual RR = time between last detected QRS complex and previously detected QRS 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 analysis 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 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. 54 Chapter 6 Reference Welch Allyn Micropaq Monitor Pulse oximetry (SpO2) specifications - Masimo Characteristic Saturation (% SpO2) Range Resolution Alarm Limitsa With Acuity 6.0 or higher With Acuity 5.4X or lower Probe Accuracy (Adults, Pediatrics) No Motion During Motionb Pulse Rate Range Resolution Alarm Limits Pulse Rate Accuracy No Motion During Motion2 Display Update Interval at monitor Alarm Hold-Off Time Period Circuitry Electrosurgery interference suppression Sensor Compatibility Sensor LEDs RED Wavelength INFRARED Wavelength Sensor Energies (Radiant Power) a. b. Specification 1% to 100% 1% 50% to 99% (lower); 51% to 100% (upper) 80% to 99% (lower); 81% to 100% (upper) 70% to 100% ±2 counts 0% to 69% unspecified 70% to 100% ±3 counts 0% to 69% unspecified 26 to 239 beats per minute 1 beat per minute 25 to 245 beats per minute (lower) 30 to 250 beats per minute (upper) ±3 beats per minute ±5 beats per minute 1 second 10 seconds; resets if the sensor reports levels within limits before 10 seconds elapses Microprocessor controlled Automatic self-test of oximeter when powered on Automatic setting of default parameters Automatic alarm messages Yes Compatible only with Masimo sensors listed in the Welch Allyn Products and Accessories booklet (810-0409-XX). 660 nm (nominal) 905 nm (nominal) 0.13 mW to 0.79 mW at 50 mA pulsed SpO2 alarm limit range depends on the software version of the Acuity System to which the monitor is connected. 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% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals ±1 standard deviation which encompasses 68% of the population. WARNING 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 SpO2 alarm limit range can be adjusted down to 50% saturation (with Acuity 6.0 software or higher), the SpO2 performance and accuracy is not specified below 70%. Directions for Use Chapter 6 Reference 55 Pulse oximetry (SpO2) specifications - Nellcor Characteristic Saturation (% SpO2) Range Resolution Alarm Limitsa With Acuity 6.0 or higher With Acuity 5.4X or lower Probe Accuracyb c(Adults, Pediatrics) Pulse Rate Range Resolution Alarm Limits Pulse Rate Accuracy Display Update Interval at the monitor Alarm Hold-Off Time Period Circuitry Electrosurgery interference suppression Sensor Compatibility Sensor LED Wavelengths Sensor Energies (Radiant Power) a. b. c. Specification 1% to 100% 1% 50% to 99% (lower); 51% to 100% (upper) 80% to 99% (lower); 81% to 100% (upper) 70% to 100% (0% to 69% unspecified) OxiMax Max-A, Max-AL ±2 counts OxiCliq N ±2.5 counts D-YS ±3 counts DS-100A ±3.5 counts 26 to 239 beats per minute 1 beat per minute 25 to 245 beats per minute (lower) 30 to 250 beats per minute (upper) ±3 beats per minute 1 second 10 seconds; resets if the sensor reports levels within limits before 10 seconds elapses Microprocessor controlled Automatic self-test of oximeter when powered on Automatic setting of default parameters Automatic alarm messages Yes Compatible only with Nellcor sensors listed in the Welch Allyn Products and Accessories booklet (810-0409-XX). Within 500 to 1,000 nm Does not exceed 15 mW SpO2 alarm limit range depends on the software version of the Acuity System to which the monitor is connected. Refer to the Welch Allyn Products and Accessories guide (810-0409-XX) for accuracy specifications for all Nellcor SpO2 probes recommended for use. 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 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 SpO2 alarm limit range can be adjusted down to 50% saturation (with Acuity 6.0 software or higher), the SpO2 performance and accuracy is not specified below 70%. 56 Chapter 6 Reference Welch Allyn Micropaq Monitor Patient alarm and equipment alert specifications Characteristic Visual Alarm Indicator at the monitor Flashing GREEN LED Flashing RED LED Continuously ON RED LED Flashing YELLOW LED Continuously ON YELLOW LED Audio Tone Locations Audio Tone Frequency Life-Threatening Arrhythmia Alarm Tone Pattern Patient Alarm Tone Pattern Equipment Alert Tone Pattern Audio Tone Volume Specification Normal operation Patient 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) Monitor Acuity Central Station (when connected) 2900 Hz 1 second on, 1 second off 1second on, 2 seconds off 1second on, 4 seconds off 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 Perioda HR = 3 seconds % SpO2, PR = 10 seconds Acuity-Configurable Audio Alarm Delay When a monitor is connected to an Acuity System, the audio alarms at the at the monitor 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. Visual alarm indications are not delayed. Patient Alarm Tone Silence from the The monitor LED is continuously ON RED and the audio tone is silenced for 90 monitor or Suspend from Acuity 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 The LED returns to the pre-alert state (except Low Battery remains monitor 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 For a patient alarm tone that has been silenced, resets the tone. monitor or Resume from Acuity Patient Out of Range; Transmitter An equipment alert is generated whenever the monitor fails to communicate Failure 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 Characteristic Transmitter Battery Failure a. 57 Specification An equipment alert is generated before the monitor battery becomes exhausted. To help 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 holdoff period. Display specifications Characteristic Type Resolution Active Viewing Area Pixel Pitch Pixel Size Viewing Angle Display Color Specification Monochrome passive matrix; LCD module 320 x 200 pixels 2.26 x 1.41 in. (57.5 x 35.9 mm) 0.0071 in. (0.18 mm) 0.0065 in. (0.165 mm) 6 o’clock position black on white Environmental specifications (with battery installed) Characteristic Operating Temperature Shipping and Storage Temperature Operating Altitude Shipping and Storage Altitude Operating Relative Humidity Shipping and Storage Relative Humidity Drop Shock Vibration, Random Degree of Protection Against Ingress Electromagnetic Compatibility (EMC) Specification 0° to 40° C -20° to 60° C -2,000 to 15,000 ft (-610 to 4,572 m) -2,000 to 40,000 ft (-610 to 12,192 m) 15% to 95%, noncondensing per MIL STD 810E, Procedure 1-natural 15% to 95%, noncondensing per MIL STD 810E, Procedure 1-natural 1 meter onto vinyl tile over concrete per EN60601-1 50 g 0.02g2/Hz from 10 to 500 Hz, ramping down to 0.002g2/Hz at 2000 Hz. Operating 1 hour per axis, 3 hours per test. Designed to meet RTCA DO160D, Category C. IPX1 Rating, Drip Proof per EN60529: 1991 EN60601-1-2: 2001 Caution The monitor may not meet performance specifications if it is not used or stored within these environmental specifications. 58 Chapter 6 Reference Welch Allyn Micropaq Monitor Physical specifications Protection classifications, all configurations Characteristic Specification Type of Protection against Electric Battery operation only Shock—Monitor Type: CF Battery must be recharged in separate battery charger. IEC EN 60601-1, 2nd Edition Degree of Protection Against Electric See monitor labels. CF defibrillator protected. Shock, for Parts Applied to Patients 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 and clean the monitor 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 Reorder Number Lithium Ion Battery 2EA Active A Battery Type Battery Capacity Battery Weight Battery Charger Battery Fuse Rating Specifications 008-0647-XX Operating Times on Batterya Battery Recharge Time Battery Lifetime a. Rechargeable, Lithium Ion 2 cells, 7.4 V (nominal), 8.4 V (charging), 1800 mA-hr 4.5 oz (0.13 kg) External device 5 A, 125 V (not user-accessible) Note: Internal electronic overload circuitry is used as the primary method of protection. Monitor w/ ECG only: 25 hrs Monitor w/ ECG and SpO2: 10 hrs 4 hours at 25° C (typical) 300 charge/discharge cycles to 70% of original capacity (typical) 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 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 SpO2 monitoring. WARNING The monitor battery is Lithium Ion. 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 high temperature (above 60° C or 140° F). Use only the specified monitor battery charger. Directions for Use Chapter 6 Reference Eight-bay battery charger specifications Characteristic Reorder Number Universal Battery Charger Active C Functional Specifications Capacity Protection Classificationsa Duty Cycle Type of Protection Against Electric Shock Degree of Protection Against Harmful Ingress of Water Method of Disinfection Flammable Anesthetics Environmental Specifications Operating Temperature Shipping and Storage Temperature Operating Altitude Shipping and Storage Altitude Operating Relative Humidity Shipping, Storage Relative Humidity Shock Vibration Electromagnetic Compatibility (EMC) Physical Specifications Length Width Height Weight Electrical Specifications Rated Input Rated Fuses Rated Output per charging bay (Continuous) Charge Time Output Over-Current Additional Features LED Indicators LED OFF Flashing GREEN LED 1 sec ON, 3 sec OFF 1 sec ON, 1 sec OFF Continuously ON GREEN LED Continuously ON YELLOW LED a. Per EN 60601-1 unless otherwise stated. Specification 008-0651-XX Eight charging bays; able to charge four (Lithium Ion) batteries simultaneously. Continuous Class I, (Protectively Earthed) with Double Insulation For ordinary, indoor locations only. Not suitable for autoclaving. (See cleaning instructions on “Inspect and clean the monitor and accessories” on page 45.) Not suitable for use with flammable anesthetics. 0° to 40° C -20° to 60° C -2,000 to 15,000 feet (-610 to 4,572 m) -2,000 to 40,000 feet (-610 to 12,192 m) 15% to 95%, noncondensing 15% to 95%, noncondensing 30 g 0.01g2/Hz from 5 to 500 Hz, 30 minutes per axis EN60601-1-2: 2001 15.0 in (38.1 cm) 9.0 in (22.9 cm) 3.6 in (9.1 cm) including feet 3.5 lb (1.6 kg) 100 V-240 V AC 600 mA, 50/60 ± 3 Hz, Electrical Class I T1.25 A/250V, Time-Delay 5x20mm 8.4 V ± 100 mV dc @1 A max. 4 hours typical for fully discharged battery. Automatic charge termination when charge is completed, or fault detected. Electronic overload protection Detachable power cord No battery detected. Battery detected, waiting to be charged Battery is charged Battery is charged. Battery or charging bay fault. 59 60 Chapter 6 Reference Welch Allyn Micropaq Monitor 61 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 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) 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: • Reorient or relocate the receiving antenna • Increase the distance between the equipment and the receiver • Connect the equipment to outlet on a circuit different from that to which the receiver is connected • 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 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 substitution or attachment of connecting cables and equipment other than specified by Welch Allyn. 62 Chapter 7 Compliance Welch Allyn Micropaq Monitor 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 autorisée seulement aux conditions suivantes: (1) il ne doit pas produire de brouillage et (2) l’ utilisateur du dispositif doit étre prêt à accepter tout brouillage radioélectrique reçu, même si ce brouillage est susceptible de compromettre le fonctionnement du dispositif. This Class B digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe B est conform à la norme NMB-003 du Canada. European Union Czech Welch Allyn tímto prohlašuje, ze tento RLAN device je ve shodě se základními po_adavky a dalšími příslušnými ustanoveními směrnice 1999/5/ES. Danish Undertegnede Welch Allyn erklærer herved, at følgende udstyr RLAN device overholder de væsentlige krav og øvrige relevante krav i direktiv 1999/5/EF Bij deze verklaart Welch Allyn dat deze RLAN device voldoet aan de essentiële eisen en aan de overige relevante bepalingen van Richtlijn 1999/5/EC. Hereby, Welch Allyn, declares that this RLAN device is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. Käesolevaga kinnitab Welch Allyn seadme RLAN device vastavust direktiivi 1999/5/EÜ põhinõuetele ja nimetatud direktiivist tulenevatele teistele asjakohastele sätetele. Welch Allyn vakuuttaa täten että RLAN device tyyppinen laite on direktiivin 1999/5/EY oleellisten vaatimusten ja sitä koskevien direktiivin muiden ehtojen mukainen. Par la présente, Welch Allyn déclare que ce RLAN device est conforme aux exigences essentielles et aux autres dispositions de la directive 1999/5/CE qui lui sont applicables Hiermit erklärt Welch Allyn die Übereinstimmung des Gerätes RLAN device mit den grundlegenden Anforderungen und den anderen relevanten Festlegungen der Richtlinie 1999/ 5/EG. (Wien) Dutch English Estonian Finnish French German Greek ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ Welch Allyn ΔΗΛΩΝΕΙ ΟΤΙ RLAN device ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩΔΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ ΣΧΕΤΙΚΕΣ ΔΙΑΤΑΞΕΙΣ ΤΗΣ ΟΔΗΓΙΑΣ 1999/5/ΕΚ Hungarian Alulírott, Welch Allyn nyilatkozom, hogy a RLAN device megfelel a vonatkozó alapvetõ követelményeknek és az 1999/5/EC irányelv egyéb elõírásainak. Con la presente Welch Allyn dichiara che questo RLAN device è conforme ai requisiti essenziali ed alle altre disposizioni pertinenti stabilite dalla direttiva 1999/5/CE. Italian Latvian Ar šo Welch Allyn deklarē, ka RLAN device atbilst Direktīvas 1999/5/EK būtiskajām prasībām un citiem ar to saistītajiem noteikumiem. Lithuanian Šiuo Welch Allyn deklaruoja, kad šis RLAN device atitinka esminius reikalavimus ir kitas 1999/5/EB Direktyvos nuostatas. Hawnhekk, Welch Allyn, jiddikjara li dan RLAN device jikkonforma mal-htigijiet essenzjali u ma provvedimenti ohrajn relevanti li hemm fid-Dirrettiva 1999/5/EC Welch Allyn declara que este RLAN device está conforme com os requisitos essenciais e outras disposições da Directiva 1999/5/CE. Malti Portuguese Slovak Welch Allyn týmto vyhlasuje, ze RLAN device spĺňa základné po_iadavky a všetky príslušné ustanovenia Smernice 1999/5/ES. Slovene Šiuo Welch Allyn deklaruoja, kad šis RLAN device atitinka esminius reikalavimus ir kitas 1999/5/EB Direktyvos nuostatas. 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 Spanish Directions for Use Chapter 7 Compliance Swedish 63 Härmed intygar Welch Allyn att denna RLAN device står I överensstämmelse med de väsentliga egenskapskrav och övriga relevanta bestämmelser som framgår 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. 64 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 environment. Emissions test Compliance Electromagnetic Environment—Guidance RF emissions CISPR 11 Group 2 The Model 4XX Series Monitor must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.a RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 No connection to mains (battery-operated) The Model 4XX Series Monitor is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Voltage fluctuations/flicker No connection to mains (battery-operated) emissions IEC 61000-3-3 a. The Model 4XX Series Monitor contains a 5-GHz orthogonal frequency-division multiplexing transmitter or a 2.4-GHz frequencyhopping 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&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 65 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 Level Compliance Level Electromagnetic Environment—Guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/ burst IEC 61000-4-4 ±2 kV for power supply lines ±1 kV for input/output lines No connection to mains (battery-operated). No other cables requiring EFT/Burst testing. Since there is no connection to the mains, there is no requirement for mains quality. Surge IEC 61000-4-5 ±1 kV differential mode ±2 kV common mode No connection to mains (battery-operated). Voltage dips, short interruptions, and voltage variations on powersupply input lines IEC 61000-4-11 <5% Ut (>95% dip in Ut) for 0.5 cycle 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles <5% Ut (>95% dip in Ut) for 5 sec No connection to mains (battery-operated). Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Note Ut is the AC mains voltage prior to application of the test level. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 66 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 Level Compliance Level Electromagnetic Environment—Guidance 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 IEC 61000-4-6 3 Vrms 3 Vrms 150 kHz to 80 MHz d = 1.2 Radiated RF IEC 61000-4-3 3 V/m 3 V/m 80 MHz to 2.5 GHz d = 1.2 d = 2.3 80 MHz to 800 MHz 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 surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol: Note 1 At 80 MHz and 800 MHz, the higher frequency range applies. Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 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. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Directions for Use Chapter 7 Compliance 67 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 are controlled. The customer or the user of the monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the monitor as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output Power of Transmitter Separation Distance According to Frequency of Transmitter 150 kHz to 80 MHz d = 1.2 P 80 MHz to 800 MHz d = 1.2 P 800 MHz to 2.5 GHz d = 2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (w) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 68 Chapter 7 Compliance Welch Allyn Micropaq Monitor Battery charger for the monitor Monitor Battery Charger Only- Guidance and Manufacturer’s Declaration—Electromagnetic Emissions 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. Emissions test Compliance Electromagnetic Environment—Guidance RF emissions CISPR 11 Group 1 The Battery Charger uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class A The Battery Charger is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies Directions for Use Chapter 7 Compliance 69 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 Compliance Level Electromagnetic Environment— Guidance Electrostatic discharge ±6 kV contact (ESD) ±8 kV air IEC 61000-4-2 ±6 kV contact ±8 kV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst IEC 61000-4-4 ±2 kV for power supply lines ±1 kV for input/output lines ±2 kV for power Mains power quality should be that of a supply lines typical commercial or hospital environment. ±1 kV for input/output lines Surge IEC 61000-4-5 ±1 kV differential mode ±1 kV differential ±2 kV common mode mode ±2 kV common mode Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions, and voltage variations on power-supply input lines IEC 61000-4-11 <5% Ut (>95% dip in Ut) for 0.5 cycle 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles <5% Ut (>95% dip in Ut) for 5 sec <5% Ut (>95% dip in Ut) for 0.5 cycle 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles <5% Ut (>95% dip in Ut) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of the Battery Charger requires continued operation during a power mains interruption, it is recommended that the Battery Charger be powered from an uninterruptible power supply or battery. Power frequency (50/ 60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note IEC 60601 Test level Ut is the AC mains voltage prior to application of the test level. 70 Chapter 7 Compliance Welch Allyn Micropaq Monitor 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 battery charger should assure that it is used in such an environment. Immunity test IEC 60601 Test Level Compliance Level Electromagnetic Environment—Guidance 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 IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms d = 1.2 Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m d = 1.2 d = 2.3 80 MHz to 800 MHz 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 surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol: Note 1 At 80 MHz and 800 MHz, the higher frequency range applies. Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 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 Battery Charger is used exceeds the applicable RF compliance level above, the Battery Charger should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Battery Charger. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Directions for Use Chapter 7 Compliance 71 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 Model 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 Battery Charger as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output Power of Transmitter Separation Distance According to Frequency of Transmitter 150 kHz to 80 MHz d = 1.2 P 80 MHz to 800 MHz d = 1.2 P 800 MHz to 2.5 GHz d = 2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (w) according to the transmitter manufacturer. Note 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 72 Chapter 7 Compliance Welch Allyn Micropaq Monitor 73 Index 1-Waveform display, 15 2-Waveform display, 15 5-Second waveform display, 15 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, 56 Default settings for Micropaq, 49 Download default settings, 21 DROPOUT equipment alert, 30 Messages displayed on Micropaq, 16 Micropaq operating settings, 16 Monitoring at Acuity, 41 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, 56 Alarms Adjust alarm limits at Micropaq, 37 Alarm holdoffs (delays), 35 Alarms off symbol, 12 Download defaults from Acuity, 21 Priority, 56 Respond to patient alarms, 36 Silence Alarms Key, 11 Specifications, 56 Alerts, 35 Messages, 40 Micropaq, 38 Silence Alerts Key, 11 Anemia and SpO2, 27 Anesthetics Warning, 4 Arterial occlusion and SpO2, 27 Artifact interference and waveform display, 22 Audible indicator, 10 Autoclave, caution about use, 6, 45 Battery Changing, 43 Low battery icon, 12 Recharge, 43 Recycling, 46 Specifications, 58 Battery charger Specifications, 59 Use, 43 Battery life Sleep mode, 12 BATTERY TOO LOW, 40 Beeps, 10 Bell symbol, 12 Blank display during sleep, 12 Cardiac arrest and SpO2, 27 Cautions, general, 6 Change network name, 47 Change the battery, 43 Change waveform display, 15 Charge a battery, 43 Charger Recharge a battery, 43 Specifications, 59 Cleaning, 45 Connect a new patient, 19, 21 Connect to the network, 19 Customize alarms, 21 Default 74 Index Acuity and settings, 16, 49 Operating settings, 16, 49 DEFECTIVE SPO2 SENSOR, 40 Defibrillation During SpO2 monitoring, 26 Warning, 4 Delays for alarms, 35 Demo Mode Accessing, 17 Display values, 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, 57 Waveform display options, 15 DROPOUT alert at Acuity, 30, 43 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, 57 Equipment alert Description, 38 Messages, 40 Errors Error message, 6 Error number, 6 Ethernet, 1 EXCESSIVE ECG OFFSET, 40 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 General cautions, 6 General Warnings, 4 Green LED, 10 Hazards General cautions, 6 General warnings, 4 Holdoffs (delays) for alarms, 35 Hyperbaric chamber Warning, do not use, 5, 21 Hypotension and SpO2, 27 Hypothermia and SpO2, 27 In-Service see Demo Mode Inspection, 45 Intended Use, 1 Keys Alarm/Alert Silence, 11 Scroll Up/Down, 10 Select, 11 KEY STUCK, 40 Lead off indication, 23 Lead selection, 13 LEDs defined, 10 List of patients, 20 List of rooms, 21 Lithium ion battery, 43 Lockout menu, 14, 49 Low battery icon, 12 LOW BATTERY message, 40 Magnetic Resonance Imaging see MRI Directions for Use Main Menu EXIT, 13 Menu Lock option, 14, 49 Restricting access, 14 Maintenance Inspection and cleaning, 45 Operator maintenance, 43 Masimo SET technology, 7 Menu Lock option, 14, 49 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, 49 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, 50 Monitor Audible indicators, 10 Features, 7 Out of range, 29 Recycling, 46 Specifications, 50 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, 5, 21 Index Connect the monitor, 19 Disconnection symbol, 12 Ethernet, 1 FlexNet, 8 Name change, 47 Operation out of range, 8 NEW PATIENT, 13, 34 NEW ROOM, 13, 32 NIBP While monitoring SpO2, 27 NO ECG CABLE DETECTED, 40 NO SPO2 SENSOR DETECTED, 40 Operation Default settings, 16 Settings, 16 Operator maintenance, 43 Out of range, 8 Monitor a patient out of range, 29 OxiMax technology, Nellcor, 7 Pacemaker Signal detection, display, 12 Warning, rate meters, 4 Warning, wireless radio, 6 Pacer see Pacemaker Pacer detection, 49 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, 58 Power specifications, 58 Prepare the patient, 21 Pulse oximetry see SpO2 Nellcor OxiMax technology, 7 Neonatal Not intended for use, 4 Network Access points, 8 Automatic reconnection, 8 Radio Frequency see RF Reassign Micropaq to new patient, 34 Reassign to a new room, 32 Recharge a battery, 43 75 76 Index Welch Allyn Micropaq Monitor Reconnect a recently monitored patient, 31 Reconnection to network, 8 Recycling Batteries, 46 Monitor, 46 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 Warnings, 26 While monitoring NIBP, 27 Stop monitoring a patient, 30 Symbols, display, 12 System error, 40 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, 49 Shock and SpO2, 27 Silence Alarm/Alert Key, 11 Silence alarms, 36 Simulation see Demo Mode Site preparation for ECG, 21 Sleep mode, display, 12 Snapshot Key, 10 Specifications, 50 Alarms, 56 Battery, 58 Battery charger, 59 Display, 57 Environmental, 57 Physical, 58 SpO2, 54 SpO2 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, 54 Vasoconstriction, 27 Unassigned rooms, 21 UNRECOGNIZED SPO2 SENSOR, 40 Training see Demo Mode TRANSFER, 13, 33 Transfer a patient to new room, 33 Vasoconstriction and SpO2, 27 Venous pulsations and SpO2, 26 VERY LOW BATTERY message, 40 Volume of audible indicators, 10 Warnings General, 4 SpO2, 26 Warranty service, 6 Waveform display options, 15 Wireless Warnings about limitations, 4 Wireless Local Area Network see WLAN WLAN, 1, 8 Yellow LED, 10
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