Welch Allyn FN802FH Propaq 802 LTRN User Manual part 10 of 10
Welch Allyn, Inc. Propaq 802 LTRN Users Manual part 10 of 10
Contents
Users Manual part 10 of 10
159 10 Maintenance Recharging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .159 Inspecting and Cleaning the Monitor and Accessories . . . . . . . . . . . . . . . . . . .161 Recycling Monitor Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162 Recharging the Battery The monitor battery is recharged whenever the monitor is placed into a cradle that is connected to a suitable power source. Recharging occurs whether the monitor is on or off. While in a cradle that is connected to AC power, the monitor also receives operating power from the cradle, thus preserving battery power for use when the monitor is removed. To Recharge the Battery 1. Confirm that the green “power” light (the right of two on the cradle) is on. If it is off, plug the power adapter into the cradle. 2. Insert the monitor into the cradle until it clicks into place. 3. Confirm that the green “battery charging” light on the cradle (the left of two on the cradle) is on. • If the green “battery charging” light is off, the monitor battery is already fully charged. • A steady yellow light indicates a problem with the battery or the cradle (contact a qualified service technician) or that the monitor is not properly seated in the cradle. Green: monitor is running on cradle power Green: battery is charging Yellow: battery or cradle fault, or monitor is not properly seated in the cradle Release button 160 Maintenance Welch Allyn Propaq LT Vital Signs Monitor Note The yellow light might flash briefly when the monitor is being inserted in the cradle or removed from the cradle. This is normal behavior and does not indicate a problem. 4. When the battery is fully charged, the green “battery charging” light is off. • Keep the monitor in the cradle whenever the patient is in bed. This keeps the monitor battery at full charge, so that it is ready for use if it must be removed from the cradle. • You can leave the monitor in the cradle when the battery is fully charged. WARNING Do not incinerate, submerge, crush, disassemble, or autoclave the lithium-ion battery. Caution Do not remove or replace the battery unless you are a Welch Allyn qualified service technician. Caution Do not use the monitor while the battery is being replaced. Directions for Use Maintenance 161 Inspecting and Cleaning the Monitor and Accessories WARNING Do not autoclave the monitor, the cradle, the AC power adapter, or any accessories. WARNING Do not immerse the monitor, the cradle, or the AC power adapter 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. WARNING Fire and electrical shock hazard. Always unplug the AC power adapter from the electrical power outlet before inspecting or cleaning the cradle, the AC power adapter, or the monitor. Exposing any of these to liquids, such as cleaning solutions, while they are connected to electrical power could result in electrical shock or fire. Before cleaning the monitor, cradle, AC power adapter, or any accessories, thoroughly inspect them. • Look for any signs of damage and any improper mechanical function of buttons or connectors. • Gently bend and flex cables, inspecting them for damage or extreme wear, exposed wires, or bent connectors. • Confirm that all connectors engage securely. Immediately report any sign of damage or malfunction to your service department. At least once per year, thoroughly inspect the cradle and the AC adapter power cord for damage or extreme wear. To clean the monitor, the cradle, or any accessories, follow these steps: 1. Wipe the equipment with a cloth slightly moistened (not wet) with one of the approved cleaning solutions listed in Table 12 on page 162. 2. Thoroughly wipe off any excess cleaning solution. Do not let the cleaning solution run into or accumulate in connector openings, latches, or crevices. If liquid gets into connectors, dry the area with warm air, and then check the equipment to confirm that it operates properly. Caution Use only a cleaning solution recommended by Welch Allyn for this equipment. Use of any other cleaning solutions which have a high acid content or are otherwise inappropriate can cause damage to the equipment, including cracking and deterioration of the plastic case. Caution Always follow the mixing/diluting instructions provided by the manufacturer of the cleaning solution. 162 Maintenance Welch Allyn Propaq LT Vital Signs Monitor Caution Never use any of the following solutions or similar products to clean the equipment: butyl alcohol, denatured ethanol, Freon™, mild chlorine bleach solution, isopropyl alcohol (except for the SpO2 cable), trichloroethane, trichloroethylene, acetone, Vesphene II, Enviroquat®, Staphene®, Misty®, Glutaraldehyde, Formula 409®, or Fantastik®. Table 12. Cleaning Instructions and Cleaning Solutions Equipment Cleaning Instructions Approved Cleaning Solutions • Wipe with a nearly dry cloth moistened with Monitor cleaning solution. Charging/ Communication Cradlea • Thoroughly wipe off any excess cleaning solution. 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 70% isopropyl alcohol pad. and allow it to dry. Other accessories • Consult manufacturer’s instructions. a. b. c. Consult manufacturer’s instructions. The equipment can 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 connectors, dry the area with warm air and then verify all monitoring functions. 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 Within the EU Do not dispose of this product as ‘unsorted municipal waste’. Prepare it for reuse or separate collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). Note If the monitor, the cradle, or the battery is contaminated, this directive does not apply. For more specific disposal information, see www.welchallyn.com/weee, or contact Welch Allyn Customer Service. Outside the EU When the monitor, the cradle, or the battery reaches end of life, recycle it locally according to national, state, and local regulations, or return it to Welch Allyn. 163 Specifications ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .163 Resp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .166 SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167 NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .168 Alarms and Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170 Wireless Monitor (Model 802LTRN) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172 Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173 Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173 Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174 Cradle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176 ECG Table 13. Specification: ECG Characteristic Specification Regulatory standards Meets ANSI/AAMI EC13-2002 and EN 60601-1:1990 + A1 + A2 Connector Hypertronics 9-pin female D01 latching connector Selectable leads 3-lead cable 5-lead cable Displayable Internally provides Displayable Internally provides I, II or III I, II or III I, II, III, aVR, aVL, aVF, V I/II, III and V Cable type detection Automatic detection and differentiation of 3- or 5-lead cable 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 (monitor display) 0.5 to 40 Hz 0.05 to 40 Hz 0.5 to 80 Hz 0.05 to 80 Hz Monitor Mode, Adult Extended Mode, Adult Monitor Mode, Pediatric or Neonate Extended Mode, Pediatric or Neonate Bandwidth (to Acuity) 0.05 to 80 Hz Monitor or Extended Mode, Adult, Pediatric, or Neonate Notch filters 50 and 100 Hz, 60 and 120 Hz, or OFF, selectable at Acuity or at the monitor 164 Specifications Welch Allyn Propaq LT Vital Signs Monitor Table 13. Specification: ECG (continued) Sample rate 363.64 Hz (181.82 Hz to Acuity) Input protection Protected against electrosurgery and defibrillator when used with ECG cables specified in the Welch Allyn Products and Accessories guide. Electrosurgery interference suppression Included on all vectors when Welch Allyn-approved cables are used. Lead-fail sense current 70 nA DC typical for active leads 140-280 nA DC typical for reference electrode, depending on number attached. Tall T-wave rejection Meets AAMI (USA) EC13-2002, section 4.1.2.1.c, up through 1.2 mV, using AAMI test waveform Common mode rejection FILTER function OFF FILTER function ON < 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 Input impedance > 2.5 MΩ single-ended @ 60 Hz Input range (AC) 10 mV peak-to-peak (local display) 10 mV peak-to-peak (Acuity) Input range (DC) Up to ±500 mV Accuracy of input signal reproduction-impulse response Requires ECG bandwidth to be set to extended mode. System noise ≤ 30 µV peak-to-peak, RTI notch filter on Baseline recovery (trace restore) Automatic QRS detector Adult or pediatric amplitude range: 0.22 to 5.0 mV (RTI) Neonate amplitude range: 0.1 to 5.0 mV Adult width range (duration): 70 to 120 msec Pediatric or neonate width range (duration): 40 to 120 msec HR range (in all patient modes) 25 to 350 beats/min (measurement) 25 to 300 beats/min (display) Alarm limits 25 to 298 beats/min (lower) 27 to 300 beats/min (upper) HR resolution 1 beat/min HR alarm resolution 5 beats/min HR meter response time Responds to change in heart rate within 13 seconds depending on physiological waveform. (As measured per AAMI standard EC13-2002 clause 5.1.2.1 (f), including 4.1.2.1 parts f. and g. waveforms.) Includes 1-second readout update interval. HR accuracy ±3 beats/min or 3%, whichever is greater HR display update interval at monitor 1 second AAMI HR response to “ineffectively paced QRS pattern” Indicates rate of 30 to 46 during AAMI EC13-2002 part 5.1.4 part (f), (g), and (h) tests. NOTE: AAMI Test 5.1.4 part (f), (g), and (h): Accuracy is affected when QRS and pacer spikes are nearly simultaneous as occasionally is the case during this test. Directions for Use Specifications 165 Table 13. Specification: ECG (continued) HR averaging method HR = 60/(latest average interval in seconds) For higher HR, latest avg interval = 7/8 (previous avg interval) + 1/8 (latest interval). For lower HR, latest avg interval = 3/4 (previous avg interval) + 1/4 (latest interval). Transition rates for choice of formula include hysteresis and are 70 and 80 beats/min. Drift tolerance (AAMI spec. EC13-2002, 4.2.6.3) 80 beats/min indicated for 80 beats/min ECG plus drift waveform Pacer pulse display indication Pacer indicator (dashed vertical marker) shown on screen if pacer indicator is ON; pacer signal always shown if of sufficient amplitude. Pacer pulse detection (i.e., for which the monitor displays a dashed vertical marker in trace) Pulses = ± 3.2 mV to ± 700 mV @ 0.1 ms and ± 2 mV to ± 700 mV @ 0.2 to 2 ms, all with or without overshoot, in electrically quiet environment. Thresholds automatically adjust to reject repetitive ambient noise. Pacer detector influences QRS picking even while pacer display indication is disabled. Pacer pulse rejection Does not count as heartbeats approximately 95% of pacemaker pulses within pacer pulse detection range, with or without AAMI (EC 13-2002) tails of 4, 8, 15, 25, 50, 75, or 100 ms decay time constant, whose tail amplitudes meet either EC 13’s method A or method B criteria for single pacer pulses, or A-V sequential pulses (150 ms and 250 ms separation), all per AAMI tests 4.1.4.1 and 4.1.4.2. Pacer pulse detector minimum 2.5 V/sec RTI, per EC13:2002, 4.1.4.3 slew rate detection threshold ECG trace duration 3 seconds in single or double trace display 6 seconds in cascade Response to Irregular Rhythm (AAMI specification EC13-2002, 4.1.2.1. Part e.) Ventricular bigeminy (VB) 78 to 81 beats/min (80 beats/min expected) Slow alternating VB 57 to 65 beats/min (60 beats/min expected) Rapid alternating VB 118 to 123 beats/min (120 beats/min expected) Bidirectional systole 88 to 93 beats/min (90 beats/min expected) 1 mV ventricular tachycardia 197 to 198 beats/min (206 beats/min expected) 2 mV ventricular tachycardia 193 to 197 beats/min (195 beats/min expected) 166 Specifications Welch Allyn Propaq LT Vital Signs Monitor Resp Table 14. Specification: Impedance Pneumography (Resp) Characteristic Specification Connector (shared with ECG) Hypertronics 9-pin, female D01 latching connector Input protection Electrosurgery and defibrillator protected and Resp fully functional when used with any of the ECG cables specified in Welch Allyn Products and Accessories (810-0409-XX) Electrosurgery interference suppression Yes, but not quantifiable. Selectable Leads Ld-1 (RA-LA), or Ld-2 (RA-LL) from either 3-lead cable or 5-lead cable, when using an ECG cable specified for this monitor in Products and Accessories (810-0409-XX). Base impedance range (in addition Approximately 200 ohms to 1200 ohms is normal monitoring range. to 1K resistors in ECG cable) Approximately 1200 –1500 ohms range produces equipment alert “Resp Fault. Noisy signal. Check electrodes”. Above approximately 1500 ohms produces equipment alert “Resp Fault. Lead Fail”. Thresholds depend on ECG cable type and length. Impedance dynamic range 20 ohms Baseline recovery (trace restore) Automatic Resp size (sensitivity) selections 0.5X, 1X, 2X, 4X, 8X, 16X Signal bandwidth after detection (Monitor display and at Acuity) 0.05 to 4.0 Hz at 3dB point Sample rate 22.73 Hz Cardiovascular artifact (CVA) rejection Presence of CVA is detected automatically. Breaths are picked in the presence of CVA unless the breath rate is within 5% of the heart rate or a submultiple of the heart rate. Resp channel noise ≤ 50 milliohms peak-to-peak typical Breath detection threshold 0.14 ohms or 2x CVA, whichever is greater, set automatically Resp rate (RR) range 2 to 150 breaths/min (adult/pediatric mode) 3 to 150 breaths/min (neonate mode) RR alarm limits 2 to 148 breaths/min (lower, adult/pediatric) 4 to 150 breaths/min (upper, adult/pediatric) 3 to 148 breaths/min (lower, neonate) 5 to 150 breaths/min (upper, neonate) Resp rate resolution 1 breath/min Resp rate alarm resolution 1 breath/min Breath rate accuracy ± 2 breaths/min or 2%, whichever is greater Motion artifact rejection Not rejected Obstructive apnea Not detected RR display update interval at monitor 1 second Excitation signal characteristics 65.16 kHz, pseudosine wave, 65 µA RMS ± 5% Display sweep speed 6.25 mm/sec Directions for Use Specifications 167 SpO2 Table 15. Specification: Pulse Oximetry (SpO2) Characteristic Specification Saturation (% SpO2) Range Resolution 1% to 100%, but limited by sensors and by sensor manufacturers’ technology 1% Alarm limits 50% to 98% (lower) 52% to 100% (upper) Probe accuracy (adult, pediatric, neonate) Accuracy for saturation levels below 70% is unspecified. See Table 16, “Specification: Pulse Oximetry (SpO2) Nellcor Sensor” on page 167 for sensor accuracy. Pulse rate alarm limits 25 to 298 beats/min (lower) 27 to 300 beats/min (upper) Pulse rate accuracy ± 3 beats/min typical; varies with sensor model Display update interval at the monitor 1 second Alarm hold-off 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 Sensor lights Red wavelength Infrared wavelength Compatible only with Nellcor sensors listed in Table 16, “Specification: Pulse Oximetry (SpO2) Nellcor Sensor” on page 167. 660 nm (nominal) 920 nm (nominal) Table 16. Specification: Pulse Oximetry (SpO2) Nellcor Sensor Application Site(s) Measurement Rangea Accuracyb (digits) MAX-A Adult Finger, thumb or toe 70% to 100% ± 2% c MAX-AL Adult (36” cable) Finger, thumb or toe 70% to 100% ± 2% c MAX-N Adult Finger 70% to 100% ± 2% c MAX-N Neonatal Foot 70% to 100% ± 3% c MAX-P Pediatric Finger, thumb or toe 70% to 100% ± 2% c MAX-I Infant Great toe or thumb 70% to 100% ± 2% c MAX-FAST Adult Forehead 70% to 100% ± 2% MAX-R Adult Nose 70% to 100% ± 3.5% Sensor Single Use - OxiMax 168 Specifications Welch Allyn Propaq LT Vital Signs Monitor Table 16. Specification: Pulse Oximetry (SpO2) Nellcor Sensor (continued) Single Use - OxiCliq OxiCliq A Adult Finger, thumb or toe 70% to 100% ± 2.5% OxiCliq P Pediatric Finger, thumb or toe 70% to 100% ± 2.5% OxiCliq N Adult Finger 70% to 100% ± 2.5% OxiCliq N Neonate Foot or hand 70% to 100% ± 3.5% OxiCliq I Infant Great toe or thumb 70% to 100% ± 2.5% D-YS DURA-Y, Multisite (with D-YSE, Earclip Ear lobe or pinna for use with D-YS) 70% to 100% ± 3.5% D-YS Neonate Ear lobe or pinna 70% to 100% ± 4% D-YS Infant to Adult Ear lobe or pinna 70% to 100% ± 3% DS-100A DURASENSOR Adult Index finger 70% to 100% ± 3% OXI-A/N OXIBAND Adult Finger, thumb or toe 70% to 100% ± 3% OXI-A/N OXIBAND Neonatal Foot or hand 70% to 100% ± 4% OXI-P/I Pediatric Finger, thumb or great toe 70% to 100% ± 3% OXI-P/I Infant Great toe 70% to 100% ± 3% Reusable a. b. c. Probe accuracy for saturation levels below 70% is unspecified. When sensors are used on neonatal subjects as recommended, the specified accuracy range is increased by ± 1 digit as compared to adult usage, to account for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood. For example, MAX-N accuracy on neonates is ± 3 digits, rather than ± 2 digits for adults. The accuracy specification under motion conditions is ± 3. NIBP Table 17. Specification: Noninvasive Blood Pressure (NIBP) Characteristic Specification Method Oscillometric Regulatory standards Meets AAMI SP10:2002, IEC 60601-1:1990, IEC 60601-2-30:1999(E); EN 1060-1:1996, EN 1060-3:1997 Control Automatic (at selected intervals), turbo, and manual Auto intervals 1, 2, 3, 5, 10, 15, 30, and 60 minutes Smartcuf (Available in 2006) Available when ECG is used on adult patients Reported pressures Systolic, diastolic, and mean plus real-time manometer pressure Pressure resolution 1 mmHg Directions for Use Specifications 169 Table 17. Specification: Noninvasive Blood Pressure (NIBP) (continued) Systolic range Alarm limits Diastolic range Alarm limits Mean range Alarm limits Pulse rate range Alarm limits Adult Pediatric Neonate 30 to 260 mmHg 30 to 160 mmHg 25 to 120 mmHg Adult Pediatric Neonate low 30 to 258 mmHg low 30 to 158 mmHg low 25 to 118 mmHg Adult Pediatric Neonate 20 to 235 mmHg 15 to 130 mmHg 10 to 105 mmHg} Adult Pediatric Neonate low 20 to 233 mmHg low 15 to 128 mmHg low 10 to 103 mmHg Adult Pediatric Neonate 20 to 255 mmHg 15 to 140 mmHg 10 to 110 mmHg Adult Pediatric Neonate low 20 to 253 mmHg low 15 to 138 mmHg low 10 to 108 mmHg high high high 32 to 260 mmHg 32 to 160 mmHg 27 to 120 mmHg high high high 22 to 235 mmHg 17 to 130 mmHg 12 to 105 mmHg high high high 22 to 255 mmHg 17 to 140 mmHg 12 to 110 mmHg 30 to 220 beats/min, in adult, pediatric, and neonate modes Low high 25 to 298 beats/min 27 to 300 beats/min Static manometer accuracy 0-300mmHg ±3 mmHg or 2% of reading, whichever is greater. Can be checked in the field, but no adjustments are provided (or needed). Manometer baselining (zeroing) Automatic Atmospheric pressure compensation Automatic Minimum inflation pressure Adult Pediatric Neonate 100 mmHg 80 mmHg 50 mmHg Maximum inflation pressure Adult Pediatric Neonate 270 mmHg 170 mmHg 132 mmHg Default inflation pressure Adult Pediatric Neonate 160 mmHg 120 mmHg 90 mmHg Normal overpressure limit Adult Pediatric Neonate 280 mmHg 200 mmHg 141 mmHg Single fault overpressure limit Adult Pediatric Neonate 308 mmHg 220 mmHg 154 mmHg 170 Specifications Welch Allyn Propaq LT Vital Signs Monitor Table 17. Specification: Noninvasive Blood Pressure (NIBP) (continued) Leak rate (manufacturing spec) After a 1-minute settling period, not more than 1 mmHg per second at 200 mmHg when connected to a volume of at least 15 cc. Rapid exhaust (dump) time 3 seconds typical to drop pressure in a 500 cc volume from 300 mmHg to < 10 mmHg Cuff inflation time 7-8 seconds typical to 270 mmHg into a 500 cc volume in adult mode at sea level Maximum determination time (without retries) Adult Pediatric Neonate Minimum time between automatic measurements 30 seconds (Auto Mode) 2 seconds (Turbo Mode) Allowable retries Two in each patient mode Electrosurgery interference suppression Included 3 minutes 2 minutes 1.5 minutes Alarms and Alerts Characteristic Specification Visual alarm indicator at the monitor Patient alarm Flashing red 0.3 seconds on, 0.3 seconds off Equipment alert Flashing yellow 1.0 seconds on, 1.0 seconds off Any alarm limit disabled Continuous yellow Visual alarm indicator at Acuity (when connected) See Acuity Directions For Use. Alarm indicators Red lights Alert indicators Yellow lights Audible alarm location Monitor Acuity (when connected) Audio tone frequency (at the monitor) 1024 Hz Audio tone volume (d = 1 meter) (Can be configured with distinct tone volume settings for standalone and networked operation.) High Medium Low Off 67 dB typical (A) 60 dB typical (A) 53 dB typical (A) Audio alarm indicator at the monitor Patient alarm high-priority limit violation [100 ms on, 80 ms off, 100 ms on, 80 ms off, 100 ms on, 260 ms off, 100 ms on, 80 ms off, 100 ms on, 1 sec off, 100 ms on, 80 ms off, 100 ms on, 80 ms off, 100 ms on, 260 ms off, 100 ms on, 80 ms off, 100 ms on, 4 sec off]; repeat. Equipment alert medium priority [160 ms on, 200 ms off, 160 ms on, 200 ms off, 160 ms on, 3.96 sec off]; repeat. Directions for Use Specifications 171 Limits Settable on all parameters Separate adult/pediatric/neonate mode settable limits Alarm control Automatic preset or manual settings Alarm priority High Medium Low Alarm on tachycardias Most tachycardias alarm in less than 8 seconds. These include AAMI 3.1.2.1 part f. waveforms. Certain multifocal tachycardias can initially alarm as “low rate.” Alarm hold-off period HR/PR % SpO2 RR Patient alarms (Life-threatening) Equipment alerts Alarm off 3 seconds 10 seconds 5 seconds To keep false alarms to a minimum, the monitor briefly delays or “holds off” triggering audible and visual alarms for limit violations for these vital signs. After the hold-off period begins, if the monitor detects that the vital sign has returned to acceptable limits, the monitor cancels the alarm. The next time a limit is violated, the monitor starts a new hold-off. Audio alarm hold-off with Acuity When a monitor is connected to Acuity, 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. Visual alarm indications are not delayed. Acuity has a default audio alarm hold-off of 11 seconds. Alarms suspend When ‘alarms suspend’ is enabled, the monitor alarm tones for all parameters can be suspended on the floor for a configurable period: 90 seconds, 2 minutes, 3 minutes, 4 minutes (default), 5 minutes, 10 minutes, 15 minutes, or 60 minutes. Patient out-of-range; transmitter failure When a monitor is used with Acuity, an equipment alert is generated whenever the monitor fails to communicate with Acuity after a connection has been successfully established. In addition, the ‘No Acuity’ icon is displayed on the monitor. Battery failure An equipment alert is generated before the monitor battery becomes exhausted. Snapshot/event mark When is pressed, the monitor records a Snapshot. If the monitor is connected to Acuity, the monitor also sends a message to Acuity so Acuity can mark and print it. Table 18. Specification: Default Alarm Limits Characteristic Specification Upper Lower HR/PR Adult Pediatric Neonate 120 beats/min 150 beats/min 150 beats/min Adult Pediatric Neonate 50 beats/min 50 beats/min 50 beats/min Resp Adult Pediatric Neonate 30 breaths/min 45 breaths/min 60 breaths/min Adult Pediatric Neonate 5 breaths/min 10 breaths/min 10 breaths/min SpO2 Adult Pediatric Neonate 100% 100% 98% Adult Pediatric Neonate 90% 90% 85% 172 Specifications Welch Allyn Propaq LT Vital Signs Monitor Table 18. Specification: Default Alarm Limits (continued) NIBP Systolic Adult Pediatric Neonate 220 145 100 Adult Pediatric Neonate 75 75 50 NIBP Diastolic Adult Pediatric Neonate 110 100 70 Adult Pediatric Neonate 35 35 30 NIBP MAP Adult Pediatric Neonate 120 110 80 Adult Pediatric Neonate 50 50 35 Table 19. Specification: Display Characteristic Specification Type Color transflective; LCD module Resolution 320 x 240 pixels Quarter VGA Active viewing area > 3.5” (8.9 cm) diagonal Pixel pitch 0.2235 mm X 0.2235 mm Viewing angle ± 40° from normal, horizontal and vertical; Contrast ratio > 2 Daylight viewable Daylight viewable with backlight off Back light Display back light can be turned on or off Brightness (back light full on) 50 cd/m2 typical Contrast ratio 80 typical (Back light on) Display colors 256 Wireless Monitor (Model 802LTRN) Table 20. Specification: Wireless (Radio) Characteristic Specification FlexNet™ Network 2.4 GHz frequency-hopping spread-spectrum (FHSS) wireless local area network (WLAN) and 10/100 base-T Ethernet network Frequency 2.402 to 2.480 GHz (subject to country-specific variations within this range) Modulation GPSK Output power 100 mW IEEE 802.11 compliant Yes Monitors per access point 15 (max.) Directions for Use Specifications 173 Environmental Caution The monitor might not meet performance specifications if it is not used or stored within these environmental specifications. Note The specifications apply when the battery is installed and the battery cover is in place. Table 21. Specification Characteristic Specification Operating temperature 0° to 40° C Shipping and storage temperature -20° to 60° C for monitor and cradle. See Table 25, “Specification: Monitor Battery” on page 175 for details about long-term storage of the internal monitor battery. 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 5% to 95%, noncondensing per MIL STD 810E, Procedure 1-natural Shipping and storage relative humidity 5% to 95%, noncondensing per MIL STD 810E, Procedure 1-natural Water resistance IPX1 Drop 2 meter onto vinyl tile over concrete per EN60601-1 (Cosmetic damage is not considered a failure.) Shock 75 g, 11 ms half sine waveform, three shocks per face for a total of 18 shocks. Vibration, random 0.02g2/Hz from 10 to 500 Hz, ramping down to 0.002g2/Hz at 2000 Hz. Superimposed sine frequencies of 30 Hz at 2.5 g and 60, 90, and 120 Hz at 1.5 g. Operating 1 hour per axis, 3 hours per test. Electromagnetic compatibility (EMC) EN 60601-1-2: 2001, Emission Class A for monitor with Large Color Display Interface, Emission Class B for monitor without Large Color Display Interface Physical Table 22. Specification Characteristic Specification Protection Classifications, all Configurations Type of protection against electric shock— monitor (connected to internal battery power source or to cradle.) Battery operation or connection to isolated cradle. Battery must be charged in the monitor while the monitor is in the cradle. Degree of protection against electric shock, for parts applied to patients See monitor labels. Type CF, defibrillator protected. 174 Specifications Welch Allyn Propaq LT Vital Signs Monitor Table 22. Specification (continued) Method of cleaning Not suitable for autoclaving. See “Inspecting and Cleaning the Monitor and Accessories” on page 161. Flammable anesthetics Not suitable for use with flammable anesthetics. Physical Dimensions Monitor height 5.4 in (13.71 cm) Monitor width 7.5 in (19.05 cm) Monitor depth 2.1 in (5.33 cm) Monitor weight (including battery and radio card) approximately 32 oz (0.9 kg) Power Table 23. Specification: Monitor Power Characteristic Specifications Operating Times on Battery for Ambient Temperature ≥ 20º C Standalone Continuous monitoring with minimal display use (defined as 5 minutes display use per hour) Acuity connected (Model 802LTRN) In communication, with continuous monitoring and minimal display use (5 min display use/hour) ECG and Resp only: 24 hrs ECG, Resp, SpO2. NIBP every 15 min.: 8 hours ECG and Resp only: 24 hrs ECG, Resp, SpO2. NIBP every 15 min.: 8 hours Table 24. Specification: Power Adapter Characteristic Specification Input 100-240 volts AC, 50/60 Hz, 700 mA max Output 15 volts DC ± 5% no load to 2A load Output ripple 200 mV p-p maximum (90 VAC RMS, 50 Hz, 24-watt load) Power 24 watts minimum Holdup time 1/2 sine-wave cycle, full load, 115 V/60 Hz, 230 VAC/50 Hz, per IEC EN 61000-4-11 Overvoltage protection Built in Overcurrent protection Built in Efficiency 80% minimum at full load, 115 VAC input Dielectric withstanding voltage 4.8 KV for 1 sec or 4.0 KV for 60 sec (mains) input to DC output Directions for Use Specifications 175 Table 24. Specification: Power Adapter (continued) Patient leakage current 10 μA maximum, normal condition type CF per IEC EN 60601-1 50 μA maximum, single-fault condition type CF per IEC EN 60601-1 Enclosure leakage current 100 μA maximum, per IEC EN 60601-1 Protection against harmful ingress of water IPX1 when the LED faces up IPX0 otherwise Humidity 95% per MILT-28800 Par 4.5.5.1 Strain-Relief Strength 30 N per UL/IEC EN 60950-1 and UL/IEC EN 60601 Weight ≤ 0.8 lb Insulation class (transformer) UL Rated 105° C Width 2.68 in (68 mm) Height 1.54 in (39 mm) Length 4.13 in (105 mm) Weight 10.6 oz (300 g) AC input connector IEC 60320-C8, 2.5 A rated input housing DC output connector Hypertronics DO2-size latching 3-pin male Output cable length 8 feet for IEC power cord Table 25. Specification: Monitor Battery Characteristic Specification Type 7.4 V, rechargeable, lithium ion. Field-replaceable by service technician. Capacity > 1800 mA-hr minimum Charger Contained in the cradle. Batteries are charged in place in the monitor. Fuse rating 5A, 125V – User cannot access the fuse. Note: Internal electronic overload circuitry is used as the primary method of protection. This circuit resets itself when an overload is removed. Recharge time ≤ 3 hours at 25° C (typical), with monitor either on or off. Storage -4°F to 122°F -20°C to 50°C < 30 days -20°C to 40°C 30 days to 90 days -4°F to 104°F > 90 days -4°F to 86°F -20°C to 30°C NOTE: For best charge retention during extended storage, remove the battery from the monitor. Cycle life 300 full charge/discharge cycles @ 20° C (to 70% of initial capacity) 176 Specifications Welch Allyn Propaq LT Vital Signs Monitor Cradle Table 26. Specification: Cradle Characteristic Specification Functional Capacity One monitor with internal battery. Mounting Tabletop or bed rail use. Can be attached to walls, IV poles, etc. with third-party mounting brackets. Protection Classifications Duty cycle Continuous Type of protection against electric shock Type CF isolation exists between the monitor installed in the cradle and the cradle DC power input, regardless of type of DC power input. The line-operated power adapter accessory is a type CF medical-grade power supply. Type CF isolation exists between the monitor installed in the cradle and the cradle USB connector. Degree of protection against harmful IPX1 ingress of water Method of cleaning Not suitable for autoclaving. See “Inspecting and Cleaning the Monitor and Accessories” on page 161. Flammable anesthetics Not suitable for use with flammable anesthetics. Environmental Operating temperature 0° to 40° C Shipping and storage temperature -20° to 60° C Operating altitude -500 to 15,000 feet (-152 to 4,572 m) Shipping and storage altitude -2,000 to 40,000 feet (-610 to 12,192 m) Operating relative humidity 5% to 95%, noncondensing Shipping, storage relative humidity 5% to 95%, noncondensing Shock 50 g Vibration, random 0.02g2/Hz from 10 to 500 Hz, ramping down to 0.002g2/Hz at 2000 Hz. Superimposed sine frequencies of 30 Hz at 2.5 g and 60, 90, and 120 Hz at 1.5 g. Operating 1 hour per axis, 3 hours per test. Electromagnetic compatibility (EMC) with USB option EN60601-1-2:2001 Class A without USB option EN60601-1-2:2001 Class B Physical Depth 6.0 in (15.24 cm) Width 7.6 in (19.3 cm) Height 5.7 in (14.48 cm) including feet Weight 16 oz (0.45 kg) Directions for Use Specifications 177 Table 26. Specification: Cradle (continued) Electrical Rated input 12V to 28V DC, 22 W max, current is inversely proportional to input voltage. Rated fuse (externally accessible) 3A, 250V, 2AG size, type T3A. Rated output to cradle connector Monitor power = 2 Adc max @ 8.2V - 8.6V, depending on the battery charge level. (See Charge Scheme, below.) Charge scheme Constant current ≈ 900 mA. Constant current for preconditioning ≈ 180 mA for pack voltage of 4.3V - 6.2V. Constant voltage = 8.4V ± 0.06V total at the battery cells. Charge termination triggers Charge current ≈ 90 mA. Total charge timeout ≈ 4 hours. Precondition charge timeout ≈ 1 hour. Charge time (with monitor on or off) ≤ 3 hours typical for battery fully discharged but not exhausted. The cradle can precondition most exhausted batteries, which adds to the total charge time. Charging terminates when the battery is fully charged or when a fault is detected. Charge time required on a dead battery before NIBP can be used. NIBP can be used as soon as monitor is powered by the cradle. Output overcurrent Electronic overload protection. If overload occurs, monitor must be removed and reinserted to reset the charger. Cradle-to-monitor connector Hypertronics L-Series Module D,17-pin male Power input connector Hypertronics Panel Mount D02 size latching 3-pin female Status Indicators Status light yellow Battery or cradle fault (time out, temperature out of range, a cell is overcharged, cradle latch button is pressed, monitor not seated in the cradle, overload, no battery or nonrejuvenatable battery in monitor.) Status light green Monitor connected and battery charging Status light off Monitor not connected, or monitor connected and battery fully charged Power light green DC input power is being applied to the cradle. Both lights off Cradle not powered, cradle fuse is blown, or cradle has shut itself down. Communications Functions Cradle to attached PC communications Per USB 1.1 (not fully compliant) USB device type Vendor-defined class, Full-Speed Communications (12 MBPS) USB ID Vendor: 0x0770 Device: 0x0802 USB connector USB type B female (device) 178 Specifications Welch Allyn Propaq LT Vital Signs Monitor 179 EMC Compliance Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179 Monitor, Battery-Operated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .180 Charging/Communication Cradle with Monitor . . . . . . . . . . . . . . . . . . . . . . . . .184 Monitor and Cradle with Large Color Display Interface . . . . . . . . . . . . . . . . . . .188 Overview Special precautions concerning electromagnetic compatibility (EMC) must be taken for all medical electrical equipment. • All medical electrical equipment must be installed and put into service in accordance with the EMC information provided in this document. • Portable and mobile RF communications equipment can affect the behavior of medical electrical equipment. Propaq LT Series monitors and accessories comply with all applicable and required standards for electromagnetic interference. • They do not normally affect nearby equipment and devices. • They are not normally affected by nearby equipment and devices. • It is safe to operate them in the presence of high-frequency surgical equipment; however, it is good practice to avoid using the monitors near other equipment. 180 EMC Compliance Welch Allyn Propaq LT Vital Signs Monitor Monitor, Battery-Operated Guidance and manufacturer’s declaration—electromagnetic emissions The battery-operated Propaq LT 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 1 The battery-operated Propaq LT Series monitor uses RF energy only for its internal function.a 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 The battery-operated Propaq LT 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. Harmonic emissions IEC 61000-3-2 No connection to mains (battery-operated) Voltage fluctuations/flicker emissions IEC 61000-3-3 No connection to mains (battery-operated) a. The battery-operated Propaq LT Series monitor contains 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&TTE Directive (1995/5/EC). The radio 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 EMC Compliance 181 Guidance and manufacturer’s declaration—electromagnetic immunity The battery-operated Propaq LT 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 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 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. 182 EMC Compliance Welch Allyn Propaq LT Vital Signs Monitor Guidance and manufacturer’s declaration—electromagnetic immunity The battery-operated Propaq LT 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 Electromagnetic environment—guidance level Portable and mobile RF communications equipment should be used no closer to any part of the battery-operated Propaq LT 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 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-operated Propaq LT Series monitor is used exceeds the applicable RF compliance level above, the battery-operated Propaq LT 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 battery-operated Propaq LT Series monitor. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Directions for Use EMC Compliance 183 Recommended separation distances between portable and mobile RF communications equipment and the battery-operated Propaq LT Series monitor The battery-operated Propaq LT 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-operated Propaq LT Series monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the battery-operated Propaq LT Series 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. 184 EMC Compliance Welch Allyn Propaq LT Vital Signs Monitor Charging/Communication Cradle with Monitor Guidance and manufacturer’s declaration—electromagnetic emissions The Charging/Communication Cradle with Propaq LT Series monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Charging/Communication Cradle with Propaq LT Series monitor should assure that it is used in such an environment. Note: The EMC specifications on pages 184-187 apply to the following: • Charging/Communication Cradle alone • Propaq LT Series monitor with Charging/Communication Cradle • Propaq LT Series monitor with Charging/Communication Cradle in communication via USB cable with personal computer Emissions test Compliance Electromagnetic environment—guidance RF emissions CISPR 11 Group 1 The Charging/Communication Cradle with Propaq LT Series monitor 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 The Charging/Communication Cradle with Propaq LT 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. Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies Directions for Use EMC Compliance 185 Guidance and manufacturer’s declaration—electromagnetic immunity The Charging/Communication Cradle with Propaq LT 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 Electrostatic discharge ±6 kV contact (ESD) ±8 kV air IEC 61000-4-2 Compliance level ±6 kV contact ±8 kV air Electromagnetic environment— guidance 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 Surge IED 61000-4-5 ±1 kV differential mode ±1 kV differential ±2 kV common mode mode ±2 kV common mode 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 Charging/Communication Cradle with Propaq LT Series monitor requires continued operation during a power mains interruption, it is recommended that the Charging/Communication Cradle with Propaq LT Series monitor 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 ±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 Ut is the AC mains voltage prior to application of the test level. Mains power quality should be that of a typical commercial or hospital environment. 186 EMC Compliance Welch Allyn Propaq LT Vital Signs Monitor Guidance and manufacturer’s declaration—electromagnetic immunity The Charging/Communication Cradle with Propaq LT 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 Electromagnetic environment—guidance level Portable and mobile RF communications equipment should be used no closer to any part of the Charging/Communication Cradle with Propaq LT 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 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 Charging/Communication Cradle with Propaq LT Series monitor is used exceeds the applicable RF compliance level above, the Charging/Communication Cradle with Propaq LT 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 Charging/Communication Cradle with Propaq LT Series monitor. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Directions for Use EMC Compliance 187 Recommended separation distances between portable and mobile RF communications equipment and the Charging/Communication Cradle with Propaq LT Series monitor The Charging/Communication Cradle with Propaq LT Series monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Charging/Communication Cradle with Propaq LT Series monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Charging/Communication Cradle with Propaq LT Series 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 = 1.2 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. 188 EMC Compliance Welch Allyn Propaq LT Vital Signs Monitor Monitor and Cradle with Large Color Display Interface Guidance and manufacturer’s declaration—electromagnetic emissions The Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface is intended for use in the electromagnetic environment specified below. The customer or the user of the The Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment—guidance RF emissions CISPR 11 Group 1 The Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface 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 A The Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies Directions for Use EMC Compliance 189 Guidance and manufacturer’s declaration—electromagnetic immunity The Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface is intended for use in the electromagnetic environment specified below. The customer or the user of the The Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface should assure that it is used in such an environment. Immunity test IEC 60601 test level Electrostatic discharge ±6 kV contact (ESD) ±8 kV air IEC 61000-4-2 Compliance level ±6 kV contact ±8 kV air Electromagnetic environment— guidance 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 Surge IED 61000-4-5 ±1 kV differential mode ±1 kV differential ±2 kV common mode mode ±2 kV common mode 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 The Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface requires continued operation during a power mains interruption, it is recommended that the The Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface 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 ±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 Ut is the AC mains voltage prior to application of the test level. Mains power quality should be that of a typical commercial or hospital environment. 190 EMC Compliance Welch Allyn Propaq LT Vital Signs Monitor Guidance and manufacturer’s declaration—electromagnetic immunity The Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface is intended for use in the electromagnetic environment specified below. The customer or the user of the Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance Electromagnetic environment—guidance level Portable and mobile RF communications equipment should be used no closer to any part of the Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface, 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 Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface is used exceeds the applicable RF compliance level above, the Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Propaq LT Series monitor with Charging/ Communication Cradle and Large Color Display Interface. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Directions for Use EMC Compliance 191 Recommended separation distances between portable and mobile RF communications equipment and the Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface The Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Propaq LT Series monitor with Charging/Communication Cradle and Large Color Display Interface 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 = 1.2 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. 192 EMC Compliance Welch Allyn Propaq LT Vital Signs Monitor 193 Limited Warranty This product is sold by Welch Allyn under the warranties set forth in the following paragraphs. These warranties are extended only to the end user with respect to the original purchase of this product directly from Welch Allyn or from Welch Allyn’s authorized distributors. For two years (one year for remanufactured monitors) from the date of the original delivery to the buyer, the Propaq LT Monitor and the Propaq LT Monitor Charging/ Communications Cradle are warranted to be free from functional defects in materials and workmanship and to conform in all material respects to the description of the product contained in the directions for use and other labeling of the product. This warranty is valid only under the following conditions: • The product is properly operated under conditions of normal use in accordance with applicable safety and regulatory requirements; • The product is configured, modified, adjusted and repaired only by Welch Allyn or by persons expressly authorized by Welch Allyn, in accordance with Welch Allyn’s service procedures; and • The product has not been damaged by misuse, negligence, or accident. For a period of 90 days, unless otherwise specified, this same warranty is made for any accessories provided by Welch Allyn. Under the above warranties, Welch Allyn’s sole and exclusive obligation and buyer’s sole and exclusive remedy is limited to the repair or replacement, at the discretion of Welch Allyn, free of charge, of products found to be defective during the warranty period. Warranty claims must be made, not more than seven days after expiration of the warranty period, by calling the customer service number shown below to obtain a returned material authorization number (RMA), and returning the product with the RMA documentation, transportation charges prepaid, to the address specified by Welch Allyn customer service. Welch Allyn 8500 S.W. Creekside Place Beaverton, Oregon 97008-7107 USA Telephone: (503) 530-7500 or (800) 289-2500 Facsimile: (503) 526-4200 Welch Allyn shall not be otherwise liable for any damages, including but not limited to incidental, consequential, or special damages. No express or implied warranties extend beyond the warranties defined in this document. Welch Allyn makes no warranty of merchantability or fitness for a particular purpose. 194 Limited Warranty Welch Allyn Propaq LT Vital Signs Monitor 195 Index accessories, 11 action, 32 Acuity communication, 45, 77 configuration parameters defined by, 113 disconnecting, 83 indicators on the monitor display, 19 marking snapshot events at, 171 monitor data stored at, 95 overriding monitor settings, 111 patients, arrhythmia-prone (warning), 5 reconnecting a patient, 83 responding to alarms at, 91 silencing alarms at, 87 values imposed on monitor settings, 113 adult term defined, 52 alarm defined, 85 responding, 91 alarm limits changing quickly with ParamSet, 90 customizing, 89 disabled, 170 range, 164, 166, 167, 169 alert defined, 85 messages, 91 responding to, 90 anemia and SpO2, 66 anesthetics (warning), 5 arterial occlusion and SpO2, 66 failure, 171 fault indicator, 177 recharging, 159 recycling, 162 status indicators, 3, 9, 91 blood pressure see NIBP button monitor release, 18 snapshot, 96 using, 32 Button Stuck, 91, 92 cardiac arrest and SpO2, 66 configuration adjusted for individual patients, 113 default settings, 111 download using the cradle, 17 imposed by Acuity, 111 must include a waveform display, 22 temporary, 111 configuration author, 157 connectors, 9 control lock-out, 23 cradle, 16 cuff equipment alerts, 92 placement, 65, 70 target inflation pressure, 69 customizing the monitor, 111 back light lock-out, 23 time out, 23 battery alert message, responding to, 93 charging cradle, 10, 16 conserving charge, 23 Defective SpO2 Sensor, 91, 92 defibrillation (warning), 5 Demo mode, 41 display alert messages, 91 lock-out, 23 time out, 23 196 Index Dual Waveform display, 21 ECG changing waveform scale, 60 lead placement, 58 electrosurgery (warning), 5 equipment alert messages, 91 error detection, 45 Welch Allyn Propaq LT Vital Signs Monitor messages for alerts, 91 monitor transporting with the patient, 46 monitoring blood pressure, 69 ECG, 55 new patient, 50 NIBP, 69 paced patients, 60 respiration rate (Resp), 55 SpO2, 64 motion artifact, 71 motion interference and SpO2, 66 FlexNet network, 1 hazards general warnings, 5 heart rate (HR) vs. pulse rate (PR), 20 high-frequency ventilation and Resp, 57 highlight, 32 HIPAA considerations, 12 hypotension and SpO2, 66 hypothermia and SpO2, 66 icons, 2 indicator Lead fault, 163 pacemaker, 61 indicators see status indicators intended use, 1 interface box, 24 changing waveform view, 26 installing, 27 language, selecting, 15 Large Color Display Interface, 24 Large Numerics display, 21 learning mode see Demo mode lock-out, 23 maintenance operator, 159 manometer, 73 navigation, 32 neonatal term defined, 52 network see also Acuity NIBP cuff and hose selection, 69 cuff placement, 69 monitoring, 69 warnings, 69 while monitoring SpO2, 65 noninvasive blood pressure see NIBP No SpO2 Sensor Detected, 91, 92 operator maintenance, 159 pacemaker and ECG monitoring, 60 rate meters (warning), 5 patient mode, 19 changing, 38, 52 warning, 5, 56 pediatric term defined, 52 power AC, supplied by cradle, 16 interruption (warning), 5 on/off button, 8 source, filtering to reduce interference, 62 power-up sequence, 13 pulse amplitude, 20 and NIBP measurement accuracy, 71 Directions for Use pulse rate effect on SpO2 readings, 64 pulse rate (PR) vs. heart rate (HR), 20 pulse rejection, pacemaker (warning), 6 pulse tone adjusting volume of, 68 reconnecting a patient, 83 release button, 18 Resp high-frequency ventilation, 57 review patient data at a PC, 101 at the Acuity Central Station, 101 creating a PDF, 109 routine maintenance, 159 Index wearable, 46 symbols, 2 Tabular Trends display, 21 Tabular Trends with Single Waveform display, 21 teaching mode see Demo mode time out, 23 transporting monitor and patient, 46 Unrecognized SpO2 Sensor, 91, 92 vasoconstriction and SpO2, 66 ventilation, high-frequency, and Resp, 57 safety and ECG/Resp monitoring, 55 and NIBP monitoring, 69 and SpO2 monitoring, 64 and wireless monitoring, 77 general warnings and cautions, 5 settings controlled by Acuity, 113 defined by Acuity, 113 overridden by Acuity, 111 shock and SpO2, 66 Single Waveform display, 21 Smartcuf improved NIBP accuracy, 71 SpO2 and anemia, 66 and arterial occlusion, 66 and cardiac arrest or shock, 66 and hypotension, 66 and hypothermia, 66 and light interference, 65 and motion interference, 66 and vasoconstriction, 66 monitoring, 64 while monitoring NIBP, 65 spot check, 66 status indicators, 8 battery, 91 cradle, 17, 177 network connection, 78 strap patient carry, 47 transport stretcher, 47 warnings ECG monitoring, 55 general, 5 monitoring paced patients, 61 NIBP monitoring, 69 SpO2 monitoring, 64 wireless monitoring, 77 waveform display and monitor configuration, 22 wireless operation warnings about limitations of, 5 197 198 Index Welch Allyn Propaq LT Vital Signs Monitor
Source Exif Data:
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