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
3
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:
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.
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 .
Press to silence the alarm tone.
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.
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.
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
1. Press to display the Main Menu.
2. Press to highlight LIMITS, then press to display the Alarm Limits Adjust
Menu:
3. To change an alarm limit, press or to highlight the desired limit, then press
to display the Threshold Adjustment Menu:
• 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 .
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.
Alarm limits can be adjuste
d
for HR/PR and SpO2.
Select + or - to change the limit.
38 Chapter 3 Alarms & alerts Welch Allyn Micropaq Monitor
4. To change other limits, scroll to PREVIOUS MENU, press , then select another
limit to change.
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.
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:
1. In this instance, press to acknowledge (dismiss) the alert tone and clear the
message.
If the message says “PRESS TO SILENCE,” when you press , the tone is
silenced for 90 seconds instead of dismissed.
If the monitor displays a chest diagram with a missing lead flashing, you can press
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.
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.
Note
While the monitor is connected to Acuity, settings can be changed either at the
monitor or at Acuity.
The monitor has detected tha
t
the ECG cable has been
disconnected from the
monitor.
Directions for Use Chapter 3 Alarms & alerts 39
2. If possible, determine what caused the problem and correct it.
For a list of possible messages and suggested responses, see “Alert messages and
display information” on page 40.
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.
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
a. This alert message can be acknowledged from Acuity, but not from the monitor.
The monitor detects poor ECG electrode contact.
• Check and replace ECG electrodes as needed.
Chest icon is displayed with
flashing ECG electrode(s).aThe 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.
DEFECTIVE SPO2 SENSORa
or
UNRECOGNIZED SPO2 SENSORa
The SpO2 sensor is either defective or not recognized.
• Replace the SpO2 sensor with a new, compatible SpO2 sensor.
<key name> KEY STUCKaDuring 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: <nnn>
Error ID: <nnn>
The equipment problem is so serious the monitor cannot be used.
• Contact your biomedical engineering department.
4
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
5
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.
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.
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.
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.
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.
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.
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
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.
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.
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
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.
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).
Equipment Cleaning Instructions Approved Cleaning Solutions
Monitora
Batterya
Battery Chargersa
a. 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.)
• 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
b. If liquid gets into the battery well or connectors, dry the area with warm air, then check the monitoring functions for proper operation.
Warm water, Liquid soap, Coverage®,
Windex®, Ovation®, Hydrogen peroxide
solution, Wex-cide®c, T.B.Q.®c
c. 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.
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.
L
i++
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).
To change the network name:
1. Press to access the Main Menu, then repeatedly press until SERVICE MENU
is highlighted.
2. Press 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:
then the monitor displays the following screen
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.
com.protocol demo.protocol
com1.protocol com2.protocol
com3.protocol com4.protocol
com5.protocol com6.protocol
com7.protocol com8.protocol
48 Chapter 5 Maintenance Welch Allyn Micropaq Monitor
To change the network name, make sure YES is highlighted, then press to display
the following screen:
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.
6
49
Reference
Operating settings
The following table lists all of the monitor settings and the default settings.
Parameter Set at
Monitor Set at Acuity Previous
Setting
Retained at
Monitor at
Power-Up
Monitor Default
Setting
For Each
Patient a
a. Set by clinician at Acuity Central Station.
For Entire
Acuity
Unitb
b. Set by Acuity System Administrator during system installation.
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)
No Yes No Yes Adult
ECG screen mode (Single, Dual, 5
Sec, or Full Screen) Yes No Yes Yes Single
ECG 1 Lead Selection Yes Yes Yes Yes II
ECG 2 Lead Selection Yes Yes Yes Yes V (or III if no V lead)
ECG Size (Scale) Yes No No Yes 1 mV/cm
Language No No Yes Yes English
Mains Filter (off, 50, or 60 Hz) No No Yes Yes 60
Vital Signs Alarm Volume
(high, low, or off)
With Acuity Connection
Without Acuity Connection No
No No
No Yes
Yes No
Yes off
high
Equipment Alert Volume
(high, low, or off)
With Acuity Connection
Without Acuity Connection No
No No
No Yes
Yes No
Yes off
low
HR/PR Alarm Limits
(Lower, Upper) Yes Yes Yes Yes Adult: 50, 120 bpm
Ped: 50, 150 bpm
SpO2 Alarm Limitsc
(Lower, Upper)
c. 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.)
Yes Yes Yes Yes Adult: 90, 100%
Ped: 90, 100%
Regulatory settings
(U.S., Europe, Japan) No No Yes Yes U.S.
Pacer Detection Enable No Yes No Yes On
Menu Lockout No No Yes No Off
Display Backlight Timeout No No Yes Yes 120 seconds
50 Chapter 6 Reference Welch Allyn Micropaq Monitor
Specifications
Monitor radio specifications (5 GHz)
Monitor radio specifications (2.4 GHz)
Characteristic Specification
FlexNet™ Network 5 GHz orthogonal frequency division multiplexing (OFDM) wireless local area network
(WLAN) and 10/100/1000 base-T Ethernet network
Modulation OFDM
Output power 40 mW maximum; country-dependent
IEEE standards 802.11a, 802.11e, 802.11h, 802.1X
Monitors per access point 20 (max.)
Restrictions for use in the 5 GHz bandsa
a. This device may be not be operated outdoors when using the bands 5150 to 5350 MHz (Channels 36, 40, 44, 48, 52, 56, 50, 64).
Allowed frequency bandsb
b. This device must be used with Access Points that have employed and activated a radar detection feature required for European
Community operation in the 5GHz bands. This device will operate under the control of the Access Point in order to avoid operating
on a channel occupied by any radar system in the area. The presence of nearby radar operation may result in temporary interruption
in communications of this device. The Access Point’s radar detection feature will automatically restart operation on a channel free
of radar. You may consult with the local technical support staff responsible for the wireless network to ensure the Access Point
device(s) are properly configured for European Community operation.
Allowed channel numbersc
c. To remain in conformance with European spectrum usage laws for Wireless LAN operation, the above 5 GHz channel limitations
apply. The user should check the current channel of operation. If operation is occurring outside of the allowable frequencies as
listed above, the user must cease operating the device at that location and consult the local technical support staff responsible
for the wireless network.
Countries
5.15 to 5.25 GHz 36, 40, 44, 48 Austria
5.15 to 5.35 GHz 36, 40, 44, 48, 52, 56, 60, 64 Cyprus, Czech Republic, France,
Hungary, Slovakia
5.15 to 5.35 GHz
and 5.470 to 5.725 GHz 36, 40, 44, 48, 52, 56, 60, 64, 100,
104, 108, 112, 116, 120, 124, 128,
132, 136, 140
Belgium, Bulgaria, Denmark,
Estonia, Finland, Germany, Greece,
Iceland, Ireland, Italyd, Latvia,
Liechtenstein, Lithuania,
Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Slovenia,
Spain, Sweden, Switzerland, U.K.
d. In Italy the end-user must apply for a license from the national spectrum authority to operate this device outdoors.
Characteristic Specification
FlexNet Network 2.4 GHz Wireless Local Area Network (WLAN) and 10/100 Base-T Ethernet
network
Frequencya
a. When used within certain countries, authorization for use is restricted as follows:
France: The equipment is internally restricted to the 2.448-2.482 GHz frequency range.
Spain: The equipment is internally restricted to the 2.447-2.473 GHz frequency range.
Japan: The equipment is internally restricted to the 2.473-2.495 GHz frequency range.
Italy: Operation requires a user license.
Note: The frequency ranges specified above are subject to geographic-specific regulatory authorities.
2.402 to 2.480 GHz
Modulation Frequency Hopping Spread Spectrum (FHSS)
Output Power 100 mW
IEEE 802.11 compliant Yes
Monitors per Access Point 15 (maximum) in most countries. In countries where available frequencies
are limited, this number is reduced.
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 Specification
Connector Hypertronics D01 latching 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)
Monitored: II, III, V; Derived: I, aVR, aVL, aVF
Monitored: II
Lead Fault Indicator Displayed chest icon with flashing indicator for each electrode
ECG Size (sensitivity) 0.2, 0.5, 1, 2, 4, and 8 mV/cm
Display Sweep Speed 25 mm/sec
Bandwidth
Local display
To Acuity Central Station 0.5 to 94 Hz independent of patient mode
0.05 to 94 Hz independent of patient mode
Sample Rate 364 Hz (182 Hz with turning point decimation to Acuity Central Station)
Input Protection Electrosurgery and defibrillator protected when used with ECG cables
specified in the Welch Allyn Products and Accessories booklet (810-0409-
XX).
Electrosurgery interference suppression Included on all vectors.
Lead Fail Sense Current 70 nA dc typical for active leads.
140-280 nA dc typical for reference electrode, depending on number of
electrodes attached.
Tall T-wave Rejection Meets AAMI (USA) EC13-1992, section 3.1.2.1.c, up through 1.2 mV
52 Chapter 6 Reference Welch Allyn Micropaq Monitor
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 M¾ differential @ 60 Hz
Input Range (ac) 10 mV peak to peak (local display)
10 mV peak to peak (Acuity Central Station)
Input Range (dc) Up to ±500 mV
System Noise 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
Alarm Limits
25 to 350 beats per minute (measurement)
25 to 300 beats per minute (display)
25 to 245 beats per minute (lower)
30 to 250 beats per minute (upper)
Heart Rate Meter Response Time Responds to change in heart rate within 5 to 9 seconds depending on
physiological waveform. (As measured per AAMI standard EC13-1992
clause 4.1.2.1 (f), including 3.1.2.1 parts f. and g. waveforms.) Includes 1
second readout update interval.
HR Display Update Interval at monitor 1 second
HR Accuracy ±3 beats per minute or 3%, whichever is greater
Heart Rate Response to ineffectively
paced QRS pattern Indicates rate of 30 to 46 during AAMI EC13-1992 part 3.1.4.1 part (f) and (g)
tests.
NOTE: AAMI Test 4.1.4 part f and g: Accuracy is affected (i.e., rate
increases) when 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-
1992, 3.2.6.3) 80 beats per minute indicated for 80 beats per minute ECG plus drift
waveform
Pacer Pulse Display Pacer indicator shown on screen if PACER display turned ON; pacer spike
always shown if of sufficient amplitude.
Pacer Pulse Rejection Pacer detection range (i.e., will show the dashed vertical marker) for ±3 mV
to ±700 mV @ 0.1 ms width, ±2 mV to ±700 mV @ 0.2 to 2 ms pulse width in
electrically quiet environment. Thresholds automatically adjust to reject
repetitive ambient noise. Operates even while pacer indication is disabled.
Will not count as heartbeats approximately 95% of pacemaker pulses
within pacer detection range, with or without AAMI (EC13-1992) tails of 4,
25, 50, 75, or 100 ms decay time constant, whose tail amplitudes are up to
25%, 2mV maximum, whether ventricular only, or A-V sequential pulses
(150 and 250 ms separation), all per AAMI tests 3.1.4.1 and 3.1.4.2
Response to Irregular Rhythm (AAMI Specification EC13-1992, 3.1.2.1. Part e.)
Ventricular Bigeminy (VB) 78 to 81 bpm (80 bpm expected)
Slow Alternating VB 57 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)
Characteristic Specification
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
Arrhythmia Option Determined by Acuity Arrhythmia Option software (displayed at Acuity Central Station)
The beat-to-beat heart rate (HR) value is calculated as follows:
HR = 60000/actual RR (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 Specification
Saturation (% SpO2)
Range
Resolution
Alarm Limitsa
With Acuity 6.0 or higher
With Acuity 5.4X or lower
a. SpO2 alarm limit range depends on the software version of the Acuity System to which the monitor is connected.
1% to 100%
1%
50% to 99% (lower); 51% to 100% (upper)
80% to 99% (lower); 81% to 100% (upper)
Probe Accuracy (Adults, Pediatrics)
No Motion
During Motionb
b. Motion is defined as rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a nonrepetitive motion between 1
to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory co-oximeter and
ECG monitor. This variation equals ±1 standard deviation which encompasses 68% of the population.
70% to 100% ±2 counts
0% to 69% unspecified
70% to 100% ±3 counts
0% to 69% unspecified
Pulse Rate
Range
Resolution
Alarm Limits
26 to 239 beats per minute
1 beat per minute
25 to 245 beats per minute (lower)
30 to 250 beats per minute (upper)
Pulse Rate Accuracy
No Motion
During Motion2±3 beats per minute
±5 beats per minute
Display Update Interval at monitor 1 second
Alarm Hold-Off Time Period 10 seconds; resets if the sensor reports levels within limits before 10
seconds elapses
Circuitry Microprocessor controlled
Automatic self-test of oximeter when powered on
Automatic setting of default parameters
Automatic alarm messages
Electrosurgery interference suppression Yes
Sensor Compatibility Compatible only with Masimo sensors listed in the Welch Allyn Products
and Accessories booklet (810-0409-XX).
Sensor LEDs
RED Wavelength
INFRARED Wavelength 660 nm (nominal)
905 nm (nominal)
Sensor Energies (Radiant Power) 0.13 mW to 0.79 mW at 50 mA pulsed
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 Specification
Saturation (% SpO2)
Range
Resolution
Alarm Limitsa
With Acuity 6.0 or higher
With Acuity 5.4X or lower
a. SpO2 alarm limit range depends on the software version of the Acuity System to which the monitor is connected.
1% to 100%
1%
50% to 99% (lower); 51% to 100% (upper)
80% to 99% (lower); 81% to 100% (upper)
Probe Accuracyb c(Adults, Pediatrics)
b. Refer to the Welch Allyn Products and Accessories guide (810-0409-XX) for accuracy specifications for all Nellcor SpO2 probes
recommended for use.
c. 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.
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
Pulse Rate
Range
Resolution
Alarm Limits
26 to 239 beats per minute
1 beat per minute
25 to 245 beats per minute (lower)
30 to 250 beats per minute (upper)
Pulse Rate Accuracy ±3 beats per minute
Display Update Interval at the monitor 1 second
Alarm Hold-Off Time Period 10 seconds; resets if the sensor reports levels within limits before 10
seconds elapses
Circuitry Microprocessor controlled
Automatic self-test of oximeter when powered on
Automatic setting of default parameters
Automatic alarm messages
Electrosurgery interference suppression Yes
Sensor Compatibility Compatible only with Nellcor sensors listed in the Welch Allyn Products and
Accessories booklet (810-0409-XX).
Sensor LED Wavelengths Within 500 to 1,000 nm
Sensor Energies (Radiant Power) Does not exceed 15 mW
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 Specification
Visual Alarm Indicator at the monitor
Flashing GREEN LED
Flashing RED LED
Continuously ON RED LED
Flashing YELLOW LED
Continuously ON YELLOW LED
Normal operation
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)
Audio Tone Locations Monitor
Acuity Central Station (when connected)
Audio Tone Frequency 2900 Hz
Life-Threatening Arrhythmia Alarm
Tone Pattern
Patient Alarm Tone Pattern
Equipment Alert Tone Pattern
1 second on, 1 second off
1second on, 2 seconds off
1second on, 4 seconds off
Audio Tone Volume The monitor audio tone volume is configured by the Acuity System to High,
Low, or Off. The monitor can be configured with separate audio tone volume
settings for when it is connected to an Acuity System and when it is not.
Limits Setable on all parameters
Alarm Control Automatic preset or manual settings
Alarm Priority Highest priority: Patient alarms
Lowest priority: Equipment alerts
Alarm on Tachycardias Most tachycardias will alarm in less than 8 seconds. These include AAMI
3.1.2.1 part f. waveforms. Certain multifocal tachycardias may initially alarm
as "low rate."
Alarm Holdoff Time PeriodaHR = 3 seconds
% SpO2, PR = 10 seconds
Acuity-Configurable Audio Alarm Delay
at the monitor When a monitor is connected to an Acuity System, the audio alarms at the
monitor can be delayed up to 4 minutes and 15 seconds. The delay time is
selected in Acuity software at the time of Acuity installation. Visual alarm
indications are not delayed.
Patient Alarm Tone Silence from the
monitor or Suspend from Acuity The monitor LED is continuously ON RED and the audio tone is silenced for 90
seconds (non-adjustable).
If original alarm was silenced from the monitor, new patient alarms or
equipment alerts break the silence at the monitor, but only life-threatening
arrhythmia alarms break the silence at Acuity. If original alarm suspended at
Acuity, only life-threatening arrhythmia alarms break the silence at the
monitor and Acuity.
Equipment Alert Acknowledge from the
monitor The LED returns to the pre-alert state (except Low Battery remains
continuously ON YELLOW) and the auditory tone is dismissed.
Equipment Alert Suspend from Acuity The LED is continuously ON YELLOW and the audio tone is silenced for 90
seconds (non-adjustable).
Patient Alarm Tone Reset from the
monitor or Resume from Acuity For a patient alarm tone that has been silenced, resets the tone.
Patient Out of Range; Transmitter
Failure An equipment alert is generated whenever the monitor fails to communicate
to an Acuity System after a connection has been successfully established. In
addition, the “No Acuity” icon is displayed on the monitor display.
Directions for Use Chapter 6 Reference 57
Display specifications
Environmental specifications (with battery installed)
Transmitter Battery Failure An equipment alert is generated before the monitor battery becomes
exhausted.
a. 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 hold-
off period.
Characteristic Specification
Characteristic Specification
Type Monochrome passive matrix; LCD module
Resolution 320 x 200 pixels
Active Viewing Area 2.26 x 1.41 in. (57.5 x 35.9 mm)
Pixel Pitch 0.0071 in. (0.18 mm)
Pixel Size 0.0065 in. (0.165 mm)
Viewing Angle 6 o’clock position
Display Color black on white
Characteristic Specification
Operating Temperature 0° to 40° C
Shipping and Storage Temperature -20° to 60° C
Operating Altitude -2,000 to 15,000 ft (-610 to 4,572 m)
Shipping and Storage Altitude -2,000 to 40,000 ft (-610 to 12,192 m)
Operating Relative Humidity 15% to 95%, noncondensing per MIL STD 810E, Procedure 1-natural
Shipping and Storage Relative Humidity 15% to 95%, noncondensing per MIL STD 810E, Procedure 1-natural
Drop 1 meter onto vinyl tile over concrete per EN60601-1
Shock 50 g
Vibration, Random 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 DO-
160D, Category C.
Degree of Protection Against Ingress IPX1 Rating, Drip Proof per EN60529: 1991
Electromagnetic Compatibility (EMC) 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
Battery specifications
Protection classifications, all configurations
Characteristic Specification
Type of Protection against Electric
Shock—Monitor Type: CF Battery operation only
Battery must be recharged in separate battery charger.
IEC EN 60601-1, 2nd Edition
Degree of Protection Against Electric
Shock, for Parts Applied to Patients See monitor labels. CF defibrillator protected.
IEC EN 60601-1, 2nd Edition
Recovery time following defibrillator
discharge Less than or equal to 10 seconds
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
Model 408 17.0 oz (0.48 kg)
18.6 oz (0.53 kg)
Characteristic Specifications
Reorder Number
Lithium Ion Battery
2EA Active A
008-0647-XX
Battery Type Rechargeable, Lithium Ion
Battery Capacity 2 cells, 7.4 V (nominal), 8.4 V (charging), 1800 mA-hr
Battery Weight 4.5 oz (0.13 kg)
Battery Charger External device
Battery Fuse Rating 5 A, 125 V (not user-accessible)
Note: Internal electronic overload circuitry is used as
the primary method of protection.
Operating Times on Batterya
a. Battery operating times based on these conditions: new fully-charged battery operating at 25° C,
the monitor connected to Acuity, eight patient alarms per hour, minimal motion artifact.
Monitor w/ ECG only: 25 hrs
Monitor w/ ECG and SpO2: 10 hrs
Battery Recharge Time 4 hours at 25° C (typical)
Battery Lifetime 300 charge/discharge cycles to 70% of original
capacity (typical)
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 59
Eight-bay battery charger specifications
Characteristic Specification
Reorder Number
Universal Battery Charger
Active C
008-0651-XX
Functional Specifications
Capacity Eight charging bays; able to charge four (Lithium Ion) batteries
simultaneously.
Protection Classificationsa
a. Per EN 60601-1 unless otherwise stated.
Duty Cycle Continuous
Type of Protection Against Electric
Shock Class I, (Protectively Earthed) with Double Insulation
Degree of Protection Against Harmful
Ingress of Water For ordinary, indoor locations only.
Method of Disinfection Not suitable for autoclaving. (See cleaning instructions on “Inspect and
clean the monitor and accessories” on page 45.)
Flammable Anesthetics Not suitable for use with flammable anesthetics.
Environmental Specifications
Operating Temperature 0° to 40° C
Shipping and Storage Temperature -20° to 60° C
Operating Altitude -2,000 to 15,000 feet (-610 to 4,572 m)
Shipping and Storage Altitude -2,000 to 40,000 feet (-610 to 12,192 m)
Operating Relative Humidity 15% to 95%, noncondensing
Shipping, Storage Relative Humidity 15% to 95%, noncondensing
Shock 30 g
Vibration 0.01g2/Hz from 5 to 500 Hz, 30 minutes per axis
Electromagnetic Compatibility (EMC) EN60601-1-2: 2001
Physical Specifications
Length 15.0 in (38.1 cm)
Width 9.0 in (22.9 cm)
Height 3.6 in (9.1 cm) including feet
Weight 3.5 lb (1.6 kg)
Electrical Specifications
Rated Input 100 V-240 V AC 600 mA, 50/60 ± 3 Hz, Electrical Class I
Rated Fuses T1.25 A/250V, Time-Delay 5x20mm
Rated Output per charging bay
(Continuous) 8.4 V ± 100 mV dc @1 A max.
Charge Time 4 hours typical for fully discharged battery. Automatic charge termination
when charge is completed, or fault detected.
Output Over-Current Electronic overload protection
Additional Features Detachable power cord
LED Indicators
LED OFF No battery detected.
Flashing GREEN LED
1 sec ON, 3 sec OFF
1 sec ON, 1 sec OFF Battery detected, waiting to be charged
Battery is charged
Continuously ON GREEN LED Battery is charged.
Continuously ON YELLOW LED Battery or charging bay fault.
60 Chapter 6 Reference Welch Allyn Micropaq Monitor
7
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
Dutch 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.
English Hereby, Welch Allyn, declares that this RLAN device is in compliance with the essential
requirements and other relevant provisions of Directive 1999/5/EC.
Estonian Käesolevaga kinnitab Welch Allyn seadme RLAN device vastavust direktiivi 1999/5/EÜ
põhinõuetele ja nimetatud direktiivist tulenevatele teistele asjakohastele sätetele.
Finnish Welch Allyn vakuuttaa täten että RLAN device tyyppinen laite on direktiivin 1999/5/EY
oleellisten vaatimusten ja sitä koskevien direktiivin muiden ehtojen mukainen.
French 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
German 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)
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.
Italian 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.
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.
Malti Hawnhekk, Welch Allyn, jiddikjara li dan RLAN device jikkonforma mal-htigijiet essenzjali u
ma provvedimenti ohrajn relevanti li hemm fid-Dirrettiva 1999/5/EC
Portuguese Welch Allyn declara que este RLAN device está conforme com os requisitos essenciais e
outras disposições da Directiva 1999/5/CE.
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.
Spanish Por medio de la presente Welch Allyn declara que el RLAN device cumple con los requisitos
esenciales y cualesquiera otras disposiciones aplicables o exigibles de la Directiva 1999/5/CE
Directions for Use Chapter 7 Compliance 63
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.
Swedish 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.
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
a. The Model 4XX Series Monitor contains a 5-GHz orthogonal frequency-division multiplexing transmitter or a 2.4-GHz frequency-
hopping spread-spectrum transmitter for the purpose of wireless communication. The radio is operated according to the requirements
of various agencies, including FCC 47 CFR 15.247 and R&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.
RF emissions
CISPR 11 Class B 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.
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)
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 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 Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
Note Ut is the AC mains voltage prior to application of the test level.
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
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 80 MHz to 800 MHz
d = 2.3 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts 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.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Model 4XX Series Monitor is used exceeds the applicable RF compliance level above, the Model 4XX Series
Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the monitor.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
P
P
P
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
W
Separation Distance According to Frequency of Transmitter
m
150 kHz to 80 MHz
d = 1.2 80 MHz to 800 MHz
d = 1.2 800 MHz to 2.5 GHz
d = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated using the equation 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.
P P P
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 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.
Harmonic emissions
IEC 61000-3-2 Class A
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 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
±2 kV for power
supply lines
±1 kV for input/output
lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5 ±1 kV differential mode
±2 kV common mode ±1 kV differential
mode
±2 kV common mode
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short
interruptions, and
voltage variations on
power-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 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 80 MHz to 800 MHz
d = 2.3 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts 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.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the 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.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
P
P
P
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
W
Separation Distance According to Frequency of Transmitter
m
150 kHz to 80 MHz
d = 1.2 80 MHz to 800 MHz
d = 1.2 800 MHz to 2.5 GHz
d = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated using the equation 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.
P P P
72 Chapter 7 Compliance Welch Allyn Micropaq Monitor
73
Index
1-Waveform display,15
2-Waveform display,15
5-Second waveform display,15
A
Accessories,16
Inspection and cleaning,45
Use only recommended,6, 16
Access points,8
Acuity,8
Acuity Central Station,1, 8
Alarm holdoff at Acuity,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
B
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
C
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
D
Default
74 Index Welch Allyn Micropaq Monitor
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
E
ECG
Alarm holdoff (delay),35
Electrode application,21
Electrode lead off,23
Lead selection,13
Scale selection,13
Size (scale) selection,13
Electrode application,21
Electrosurgery warning,4
END TELE,13, 30
Environmental specifications,57
Equipment alert
Description,38
Messages,40
Errors
Error message,6
Error number,6
Ethernet,1
EXCESSIVE ECG OFFSET,40
F
FCC
Warning, RF,5
Federal Communications Commission
see FCC
FlexNet,1, 8
Access points,8
Automatic reconnection,8
Defined,8
Operation out of range,8
Full Screen waveform display,15
G
General cautions,6
General Warnings,4
Green LED,10
H
Hazards
General cautions,6
General warnings,4
Holdoffs (delays) for alarms,35
Hyperbaric chamber
Warning, do not use,5, 21
Hypotension and SpO2,27
Hypothermia and SpO2,27
I
In-Service
see Demo Mode
Inspection,45
Intended Use,1
K
Keys
Alarm/Alert Silence,11
Scroll Up/Down,10
Select,11
KEY STUCK,40
L
Lead off indication,23
Lead selection,13
LEDs defined,10
List of patients,20
List of rooms,21
Lithium ion battery,43
Lockout menu,14, 49
Low battery icon,12
LOW BATTERY message,40
M
Magnetic Resonance Imaging
see MRI
Directions for Use Index 75
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
N
Nellcor
OxiMax technology,7
Neonatal
Not intended for use,4
Network
Access points,8
Automatic reconnection,8
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
O
Operation
Default settings,16
Settings,16
Operator maintenance,43
Out of range,8
Monitor a patient out of range,29
OxiMax technology, Nellcor,7
P
Pacemaker
Signal detection, display,12
Warning, rate meters,4
Warning, wireless radio,6
Pacer
see Pacemaker
Pacer detection,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
R
Radio Frequency
see RF
Reassign Micropaq to new patient,34
Reassign to a new room,32
Recharge a battery,43
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
S
Scroll Up/Down Keys,10
Select
Patient,20
Room,21
Select Patient at Central,20
Select Room at Central,21
Select Key,11
Select Room at Central,32, 33
Set patient alarms,37
SET technology, Masimo,7
Settings, operating,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
Warnings,26
While monitoring NIBP,27
Stop monitoring a patient,30
Symbols, display,12
System error,40
T
Training
see Demo Mode
TRANSFER,13, 33
Transfer a patient to new room,33
U
Unassigned rooms,21
UNRECOGNIZED SPO2 SENSOR,40
V
Vasoconstriction and SpO2,27
Venous pulsations and SpO2,26
VERY LOW BATTERY message,40
Volume of audible indicators,10
W
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
Y
Yellow LED,10