Welch Allyn PIC 50, PIC 40 User Manual
PIC40
PIC 40
PIC 50
PIC50
Part Number 991010 - Revision L
Portable Intensive Care System
USER INSTRUCTION MANUAL
Model: PIC 40 and PIC 50
Software Revision X3 through X9*
*Reference Addendum
Medical Research Laboratories, Inc.
a Welch Allyn Company
1000 Asbury Drive, Buffalo Grove, Illinois 60089
847/520-0300 (Telephone)
800/462-0777 (Toll-Free)
847/520-0303 (Fax)
www.welchallyn.com (Internet)
©1998, 1999, 2000, 2001, 2002, 2003, 2005
MRL, Inc., a Welch Allyn Company
All rights reserved. Printed in the U.S.A.
Welch Allyn Part Number 991010 - Revision L
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM I
)RUHZRUG
This manual is intended to provide information for the proper
operation of the Welch Allyn PIC 40 and PIC 50.
DO NOT ATTEMPT TO USE THIS EQUIPMENT WITHOUT
THOROUGHLY READING AND UNDERSTANDING THESE
INSTRUCTIONS.
The user is required to be trained in basic monitoring, vital signs
assessment and emergency cardiac care. The user should be
completely knowledgeable of the information in the User Instruction
Manual. As with all other electronic patient care monitors, good
clinical judgment should be used when operating the Welch Allyn
PIC.
User must save all shipping containers and packaging materials.
When shipping the PIC System and accessories for calibration,
service, or upgrades, the original shipping containers and packaging
materials must be used.
W elch Allyn, i s responsible for the safety, reliability and performance
of the Welch Allyn Portable Intensive Care System, only if the
following three conditions are met:
•
Assembly operations, extensions, readjustments,
modifications or repairs are carried out by persons
authorized by Welch Allyn.
•
The electrical installation of the relevant room complies
with the appropriate requirements.
•
The PIC equipment is used in accordance with the
instructions for use.
To ensure patient safety and proper operation, use only Welch Allyn
authorized parts and accessories.
User's
Responsibility
Manufacturer's
Responsibility
II
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
The FDA Safe Medical Device Act stipulates that each end-user is
required under penalty of law, to register with the manufacturer all
information pertinent to each medical device.
Please fill out the attached FDA Medical Device Registration
postcard and return it promptly to Welch Allyn. This card must be
filled in and returned within 30 days of product delivery.
If the medical device is transferred from your possession, you must
notify Welch Allyn of the new registration information.
Please contact W elch Allyn (800/462-0777) if you have any questions
regarding this notice.
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WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
III
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Manufacturer:
g
Medical Research Laboratories, Inc.
a Welch Allyn Company
1000 Asbury Drive
Buffalo Grove, IL 60089
USA
Phone (847) 520-0300
Fax (847) 520-0303
Welch Allyn Ireland
Navan Business Park
Dublin Road
Navan, Co. Meath
Republic of Ireland
Phone 011-353-466-7775
Fax 011-353-466-7128
declares that the CE-marked product
Product Name:
971085 — PIC50, 5-lead, Regular 972042 — 5-lead, monochrome display
971081 — PIC50, 5-lead, Basic 971044 — 5-lead, monochrome display, without defib
971082 — PIC50, 5-lead, Deluxe 973092 — PIC40, Basic
971086 — PIC50, 12-lead, Regular 973093 — PIC40, NIBP
971083 — PIC50, 12-lead, Basic 973094 — PIC40, Pacing, NIBP
971084 — PIC50, 12-lead, Deluxe 973095 — PIC40, Pacing
971001 — NIBP and Temp. 971018 — 12-lead, Analysis
971005 — Voice Memo
971008 — SAED 971024 — Data Card Record/Review
971016 — CO
971017 — IBP
PIC40/PIC50 (Portable Intensive Care)
TM
2
Base Units
Options
971019 — 12-lead FAX trans.
971074 — Nellcor, SPO
2
:
Device Type
Defibrillator / External Transcutaneous Pacemaker / Multifunction Monitor
complies with Council Directive 93/42/EEC (Medical Device Directive) of 14 June 1993 class IIb Annex II
Standards
General
Safety
EMC
______________________________________ ___________________
Joel Orlinsky Date
Director of Q.A. and Re
IV
: ISP 9001
EN 46001
: IEC 601-1 / EN 60601-1 Class I, Continuous operation
Type BF (with external paddles) or
Type CF (with internal paddles)
IEC 601-1-4 / EN 60601-1-4
IEC 601-2-4 / EN 60601-2-4
IEC 601-2-25 / EN 60601-2-25
IEC 601-2-27 / EN 60601-2-27
IEC 601-2-30 / EN 60601-2-30
IEC 601-2-34 / EN 60601-2-34
IEC 1441 / EN1441
EN 865
EN 475
EC 601-1-2/EN 60601-1-2
ulatory Affairs
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
Title Page
..........................................................................
i
Forward
............................................................................
ii
FDA Medical Device Registration
................................
iii
Declaration of Conformity
..............................................
iv
Table of Contents
.............................................................
v
Symbols and Icons
........................................................
1.2
General Precautions
......................................................
1.5
Monitoring Precautions
................................................
1.8
Defibrillator Precautions
...............................................
1.9
External Pacing Precautions
.......................................
1.11
Pulse Oximeter Precautions
........................................
1.13
Non-Invasive Blood Pressure Precautions
.................
1.14
Battery Precautions
.....................................................
1.15
Charger Precautions
....................................................
1.16
SAED Precautions
......................................................
1.17
IBP Precautions
..........................................................
1.17
CO2 Precautions
.........................................................
1.18
Product Overview
.........................................................
2.2
Indications for Use
........................................................
2.4
Part Numbers
................................................................
2.6
Options and Accessories
...............................................
2.7
Initial Installation Evaluation
.......................................
2.9
Summary of Operations
..............................................
2.11
PIC System Interfaces
..................................................
3.2
PIC System Controls and Indicators
.............................
3.4
PIC System Display Windows and Modes
...................
3.6
PIC System Defibrillation Paddles
...............................
3.8
PIC System Defibrillation Hands-Free Pads
................
3.9
ECG Monitoring Controls and Displays
......................
4.2
Quick Access Controls and Displays
............................
4.5
ECG Monitoring Operation Procedures
.......................
4.7
Outputs
........................................................................
4.12
Basic 12-lead Monitoring Controls and Displays
.........
5.2
Entering Patient ID Information
...................................
5.4
Monitoring in Normal 12-lead Mode
...........................
5.7
7DEOHRI&RQWHQWV
Safety Information ........................................................ 1.1
Introduction................................................................... 2.1
PIC System Overview ................................................... 3.1
ECG Monitoring ............................................................ 4.1
12-lead Monitoring (optional)....................................... 5.1
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
V
Active 12-Lead Monitoring Controls and Displays
......
5.8
Quick Access Functions of the
Active 12-lead Mode
.............................................
5.11
Manual Defibrillation .....................................................6.1
Manual Defibrillator Controls and Displays
.................
6.2
Manual Defibrillation Operation Procedures
................
6.5
SAED Basic Mode
........................................................
7.2
SAED Basic+ Mode
.....................................................
7.6
SAED Operation Procedures
........................................
7.7
EMS Mode
....................................................................
7.8
SAED Mode Operation with Multipurpose
Hands-Free Pads
.......................................................
7.9
Defibrillation with Paddles while in SAED Mode
.....
7.12
External Pacer Controls and Displays
..........................
8.2
External Pacer Operation Procedures
...........................
8.6
Pulse Oximeter Controls and Displays
.........................
9.2
Pulse Oximeter Operation Procedures
..........................
9.5
NIBP and TEMP Controls and Displays
....................
10.2
NIBP Operation Procedures
.......................................
10.5
Tem perature Display and Operation Procedures
........
10.8
Respiration Display
....................................................
11.2
Respiration Operation Procedures
..............................
11.4
CO2 (optional)
.............................................................
11.5
Measurement of Resp Rate Using CO
2
Monitor
........
11.8
CO2 Typical Usage Procedures
..................................
11.9
Semi-Automated External Defibrillation (optional).....7.1
External Pacing..............................................................8.1
Pulse Oximeter...............................................................9.1
Non-Invasive Blood Pressure (NIBP) and
Temperature .................................................................10.1
Respiration and CO2 (optional) ..................................11.1
VI
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
Chart Recorder Printouts
............................................
12.2
Treatment Summary
...................................................
12.6
Log Functions
.............................................................
12.9
Loading Chart Paper
.................................................
12.12
Voice Memo
..............................................................
12.13
Using the Welch Allyn Data Card
............................
12.14
Reviewing Data on the Welch Allyn Data Card
.......
12.19
Voice Memo Review
................................................
12.26
User Menu Overview
..................................................
13.2
Supervisor Menu Overview
........................................
13.4
Quick Access Buttons and Icons
................................
13.6
Quick Access Buttons and Pop-up Menus
.................
13.7
User Menus
.................................................................
13.8
User Menus – Display
................................................
13.9
User Menus – SPO
2
..................................................
13.12
User Menus – Non-Invasive Blood Pressure
............
13.13
User Menus – Respiration (ECG)
.............................
13.14
User Menus – Respiration (CO
2
)
.............................
13.16
User Menus – Respiration (Trend)
...........................
13.18
User Menus – Recorder
............................................
13.19
User Menus – Setup
..................................................
13.22
Supervisor Menus
.....................................................
13.24
Supervisor Menus – Defibrillator
.............................
13.25
Supervisor Menus – Pacer
........................................
13.27
Supervisor Menus – SAED
.......................................
13.28
Supervisor Menus – 12-lead
.....................................
13.30
Supervisor Menus – Setup
........................................
13.33
Supervisor Menus – Calibration
...............................
13.38
Supervisor Menus - Alarms
......................................
13.41
Global Alarms and Alarm Icons
.................................
14.1
Alarm Configurations (User Menus)
..........................
14.3
Heart Rate Alarms
......................................................
14.4
Pulse Oximeter (SpO
2
) Alarm
....................................
14.6
Non-Invasive Blood Pressure (NIBP) Alarm
.............
14.7
Invasive Blood Pressure (IBP) Alarm
........................
14.8
Resp Alarm
...............................................................
14.10
Temp Alarm
..............................................................
14.12
End-Tidal CO
2
(ETCO
2
) Alarm
...............................
14.14
Documentation............................................................ 12.1
Menus .......................................................................... 13.1
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
Alarms.......................................................................... 14.1
VII
Power Source ..............................................................15.1
General Safety Precautions
.........................................
15.2
Power Supply/Paddle Holder (option 971029)
...........
15.3
Power Source Controls and Indicators
.......................
15.4
Welch Allyn Quick Charger/Conditioner
...................
15.6
Battery/Charger/Defibrillator Tester
Operation Procedures
..............................................
15.8
Welch Allyn 12 Volt Vehicular Adapter
...................
15.12
Welch Allyn Battery Analyzer
..................................
15.13
Power Options Comparison Chart
............................
15.14
Maintenance
................................................................
16.1
Functional Checks
......................................................
16.4
Mandatory Minimum Preventive
Maintenance Schedule
............................................
16.8
Monthly Capacity Test
................................................
16.9
Guidelines for Maintaining Peak
Battery Performance
...............................................
16.9
Battery Capacity Test and Reconditioning
Procedures
............................................................
16.10
Cleaning Instructions
................................................
16.12
Intended Use
...............................................................
17.2
IBP Controls and Display
...........................................
17.2
IBP Operation Procedures
..........................................
17.3
Warnings and Precatuions
...........................................
18.2
12-lead Interpretive Analysis Operation
.....................
18.2
Overview
.....................................................................
19.2
Mobitex Configuration
...............................................
19.2
Cellular Configuration
................................................
19.6
Maintenance and Care ................................................16.1
IBP.................................................................................17.1
12-lead Interpretive Analysis......................................18.1
Wireless Transmission................................................19.1
Specifications ............................................................... A.1
Addendum to PIC 40/50
User Instruction Manual...............................Addendum-1
VIII
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
HAPTER
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This chapter provides informaton on the safe operation of the Welch Allyn Portable
1: S
AFETY INFORMATION
Intensive Care (PIC) S
Chapter Overview:
stem.
• Symbols and Icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.2
• General Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.5
• Monitorin
• Defibrillator Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.9
• External Pacin
• Pulse Oximeter Precautions . . . . . . . . . . . . . . . . . . . . . . . . 1.13
• Non-Invasive Blood Pressure Precautions . . . . . . . . . . . . .1.14
• Batter
• Char
• SAED Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.17
• IBP Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.17
• CO
2
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.8
Precautions . . . . . . . . . . . . . . . . . . . . . . . .1.11
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.15
er Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.16
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.18
W
ELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
1.1
6\PEROVDQG,FRQV
Graphical symbols, letter symbols and signs listed below may be
found on the PIC System and accessories distributed by Welch Allyn.
Please note the use of these symbols for safe and proper use of the
equipment.
The symbols listed below may by found throughout this manual.
WARNING
: Hazards or unsafe practices that could result in
severe personal injury or death.
CAUTION
: Hazards or unsafe practices that could result in
minor personal injury or product damage.
NOTE: Points of particular interest for more efficient or
convenient operation.
Symbols
S
AFETY INFORMATION
Alternating current For indoor use only
(on battery charger
only)
Attention, consult
accompanying
documents
Auxiliary power
operation
Caution, high
voltage
Dangerous voltage Power on
Defibrillator
protected, type BF
patient connection
Defibrillator
protected, type CF
patient connection
Earth (ground) Defibrillator
Negative input
terminal
Positive input
terminal
Power off
Recycle battery
Protective earth
(ground)
discharge button
1.2
Release
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
S
Graphical and text icons listed below may be found on the display of
the PIC System during operation.
AFETY INFORMATION
,FRQV
Alarm off
Check chart
recorder
Alarm on
Alarm lower limit
set
Alarm upper limit
set Mute
Automatic HR
Alarm set One volt output
Alarm - push to
disable QRS beeper off
Animated
recording icon QRS beeper on
Battery full Volume level
Battery low
warning
Auto heart rate
undetermined
Auto heart rate set
at 60 BPM
Supervisor menu
locked
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
Battery (partially
depleted)
Auxiliary power Notch filter On
Blood pressure
pump 1 Analyze
Blood pressure
pump 2 Internal log
Calibration pulse
12-lead Carbon dioxide on
Supervisor menu
unlock
Card review card
usage
1.3
S
AFETY INFORMATION
Invasive blood
pressure Carbon dioxide off
Resets to patient
Analyze 12-lead
Card Review/
12-lead next page SAED CPR timer
001 in card review
12-lead save
function
Fax/modem Do not sterilize
Card review/
12-lead printer
Card review card
usage and location
12-lead analysis
page up
Latching
connection
Press here to
unlatch
Quick access Log
button
12-Lead analysis
page down
1.4
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
S
The Welch Allyn PIC is intended for use by trained, authorized
medical personnel who are familiar with basic monitoring, vital signs
assessment and emergency cardiac care. The PIC is also intended for
use by physicians at the scene of an emergency or in a hospital
emergency room.
Federal (USA) law restricts this device to sale by or on the order of a
physician.
Any authorized person using the Welch Allyn PIC should be
completely knowledgeable of the information in the User Instruction
Manual.
The defibrillator function of the PIC is used to treat: ventricular
fibrillation and pulseless ventricular tachycardia. The biphasic
waveform employed by the PIC has not been clinically tested on
pediatric patients. The device has not been evaluated for
cardioversion of atrial fibrillation or direct (internal) cardiac
defibrillation. The semi-automatic mode should not be used on
pediatric patients less than 8 years old.
Use only authorized Welch Allyn accessories listed in the
Introduction chapter of this manual. Use of unauthorized accessories
may cause the device to operate improperly and provide false
measurements.
Do Not attempt to sterilize any accessory or equipment.
Proper care and maintenance of the Welch Allyn batteries is
important to insure continuous operation during patient care. If the
batteries are not maintained properly, loss of power during patient
care could result, affecting patient care. Always have a fully charged
battery pack available as a back-up.
g
If this device has been dropped or damaged in any way, refer the
device to qualified service personnel for verification of performance
and/or servicing.
T o achieve the specified level of pr otection against spilled or splashed
liquids, thoroughly dry all exposed surfaces of this device prior to
operation or connections to mains power.
AFETY INFORMATION
*HQHUDO3UHFDXWLRQV
Accessories
Sterilization
Battery Care
Dropped or
Dama
ed
Ingress of Liquids
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
1.5
Electrical Shock
Hazard
: Do not use the PIC if it has been immersed in a liquid or if
liquid has spilled on it. Do not clean the PIC with alcohol, ketone, or
any flammable agent. Do not autoclave the PIC. Conductive parts of
electrodes and connectors, for applied parts, should not contact other
conductive parts including earth.
Hazard
: This device does not contain any user-serviceable parts. Do
not remove instrument covers or attempt to repair the Welch Allyn
PIC System. Refer servicing to qualified personnel.
When obtaining a new supply of disposable electrodes for
monitoring, defibrillation or pacing, verify that they will properly
connect to the existing Welch Allyn cables prior to putting in service.
Do not use if gel is dry.
Hazard
: The PIC can deliver 360 Joules of electrical energy. If this
electrical energy is not discharged properly, as described in the User
Instruction Manual, the electrical energy could cause personal injury
or death to the operator or bystander.
Always verify expiration dates on dated items such as disposable
defibrillation or pacing pads, monitoring electrodes and battery packs.
If the expiration date has passed, replace the disposable items
immediately.
Biomedical equipment and accessories, such as ECG electrodes,
cables, and oximeter probes contain ferromagnetic materials.
Ferromagnetic equipment must not be used in the presence of high
magnetic fields created by magnetic resonance imaging (MRI)
equipment.
The large magnetic fields generated by an MRI device can attract
ferromagnetic equipment with an extremely violent force, which
could cause serious personal injury or death to persons between the
equipment and the MRI device.
Observe all PRECAUTION and WARNING labels on the Welch
Allyn PIC System and Quick Charger/Conditioner.
g
Hazard
: Care should be exercised when operating the Welch Allyn
PIC and Welch Allyn Quick Charger/Conditioner in the presence of
oxygen sources (such as near bag-valve-mask devices or ventilators),
flammable gases or anesthetics. These environments can produce fire
or explosion hazards.
Electrical Shock
(Internal)
Electrodes
(Disposable)
Energy Discharge
S
AFETY INFORMATION
Expiration Date
Ferromagnetic
Equipment
Labels
Operating Near
en
Oxy
1.6
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
S
Place the PIC System, accessories and cables in a position where they
cannot harm the patient should they fall. Keep all cables and hoses
away from patient’s neck.
The Welch Allyn PIC System may not meet performance
specifications if stored, transported, or used outside the specified
storage or operating environmental range limits.
g
To prevent incorrect trending data from being printed, clear the
Treatment Summary Log from the Recorder-Log menu prior to use
on a new patient.
AFETY INFORMATION
Patient Physical
Harm
Performance
Treatment Summary
Lo
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
1.7
0RQLWRULQJ3UHFDXWLRQV
•
WARNING: PACEMAKER PA TIENTS
. The W elch Allyn
PIC includes a pacemaker rejection circuit. The following
warning is in accordance with the disclosure requirement of
AAMI Standard EC13-3.1.2.1 (8): The rate meter may
continue to count the pacemaker rate during some
occurrences of cardiac arrest or some arrhythmias. Do not
rely upon the heart rate meter alarms to assess the patient’s
condition. Keep pacemaker patients under close surveillance.
Pacemaker pulses of the type specified in AAMI EC13-1992,
section 3.1.4, are detected at amplitudes greater than ± 20mV
and rejected by the heart rate display. However, pacemaker
pulses that are superimposed on the ECG at very low
amplitudes may be counted by the heart rate display. NOTE:
This warning is an AAMI requirement that applies to all ECG
monitors, regardless of make or model.
•
Use only Welch Allyn patient cables. Other cables can
produce excessive artifact, causing an inability to interpret
the ECG.
•
Use only ECG electrodes that meet the AAMI standard for
electrode performance (AAMI EC-12). Use of electrodes not
meeting this AAMI standard could cause the ECG trace
recovery after defibrillation to be significantly delayed.
•
The type of surface electrode and the technique used in
applying the electrodes are major factors in determining the
quality of the signal obtained. Use high-quality, silver-silver
chloride electrodes. These electrodes are designed to provide
excellent baseline stability, provide rapid recovery from
defibrillation, and minimize artifacts from patient movement.
•
When attempting to interpret subtle ECG changes (ST
segments, etc.), use only the diagnostic frequency response
mode. Other frequency response settings may cause
misinterpretation of the patient’s ECG. See Frequency
Response in chapter 13 for further details.
•
Excessive artifact can result due to improper skin preparation
of the electrode sites. Follow skin preparation instructions in
chapter 4.
•
Do not operate the PIC System in conjunction with
electrocautery or diathermy equipment. Such equipment, as
well as equipment that emits strong radio frequency signals,
can cause electrical interference and distort the ECG signal
displayed by the monitor, thereby preventing accurate rhythm
analysis.
S
AFETY INFORMATION
1.8
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
S
•
Do not operate the PIC in close proximity to any other
monitor with respiration measurements. The two devices
could affect the respiration accuracy.
•
Any external connection to the 1V or MOD outputs must
comply with clause 19 of IEC 601-1 for leakage current and
must not exceed 450 mA.
•
Shock Hazard: Use of accessories, other than those specified
in the operating instructions, may adversely affect patient
leakage currents.
•
Certain line-isolation monitors may cause interference on the
ECG display and may inhibit heart rate alarms.
•
The Welch Allyn PIC can deliver 360 joules of electrical
energy. If this electrical energy is not discharged properly, as
described in the User Instruction Manual, the electrical
energy could cause personal injury or death to the operator or
bystander.
•
The operator and all other people must stand clear of the
patient, the bed and all conductive surfaces (that are in
contact with the patient) during defibrillation. The electrical
energy delivered to the patient could also be delivered to any
other person who is in contact with the patient or the
conductive surface.
•
Do not use the defibrillator in the presence of oxygen sources
(such as near bag-valve-mask devices or ventilators),
flammable gases or anesthetics. These environments can
produce fire or explosion hazards.
•
After a synchronized cardioversion, the SYNC mode may be
cleared after each shock or disarm. The user may have to
reselect (press) the SYNC button after each synchronized
cardioversion shock performed on a patient. The PIC can be
configured in the Supervisor-Defibrillation Set-up menu to
remain in the SYNC mode after each synchronized
cardioversion.
•
Synchronized cardioversion can be performed in the paddle
monitoring mode. However, it is possible that artifact can be
produced by the moving paddles, which could cause the
defibrillator to trigger on the artifact. It is recommended that
monitoring in leads I, II or III be used during synchronized
cardioversion. Paddle monitoring should not be used for
elective cardioversions procedures.
AFETY INFORMATION
'HILEULOODWRU3UHFDXWLRQV
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
1.9
S
•
To avoid stress to the defibrillator or the tester, never attempt
to repeatedly charge and discharge the defibrillator in rapid
succession. If a need for repetitive testing arises, allow a
waiting period of at least 2 minutes for every third discharge.
•
Monitoring ECG through the paddles may result in inaccurate
heart rate display due to artifact.
•
In the SYNC mode, the defibrillator will not discharge
without a command signal (R-wave detection) from the ECG
monitor indicated by a SYNC marker on the trace, flashing
SYNC indicator, and an audible beep if the R-wave beeper is
enabled.
•
Do not use the defibrillator if excessive condensation is
visible on the device. Wipe only the outside with a damp
cloth.
•
Use only W elch Allyn-approv ed disposable defibrillation and
pacing pads and cables.
•
Defibrillator paddles should be kept clean and dry when not
in use. When preparing electrodes and during defibrillation
procedures, extreme care should be exercised to prevent gel
or any conductive material from forming a contact between
the operator and the paddles. Do not allow gel or any other
conductive material to form an electrical bridge between the
defibrillator electrodes or to the monitoring electrodes.
Electrical arcing and/or patient burns could occur during
defibrillation. Arcing and patient burns could prevent
sufficient energy delivery to the patient.
•
WARNING
: If conductive gel forms a continuous path
between the defibrillator electrodes, delivered energy may be
dramatically reduced to zero. In this case, reposition the
electrodes to eliminate the shunting path before attempting
additional shocks.
•
Improper defibrillation technique can cause skin burns. To
limit possible skin burns, use only Welch Allyn defibrillation
gel on paddles, insure the gel covers the entire paddle surface
and press firmly against patient’s chest.
•
Disposable defibrillation electrodes must be used in
accordance with the manufacturer’s instructions. Do not use
expired, dry electrodes or reuse disposable electrodes, as
improper patient contact may result in patient burns and
inability of the device to function properly.
AFETY INFORMATION
1.10
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
S
•
The device contains an automatic disarm of the capacitor
bank. If the operator has not delivered the charge to a patient
or test load, an internal timer will disarm the capacitor bank 1
minute in manual mode and 30 seconds in SAED Basic or
SAED Basic+ mode after the ready charge signal. The ready
charge signal is indicated by a continuous audible tone and
the energy availability graph displayed on the monitor.
•
If a new energy level is selected after the charge button is
pushed and while the defibrillator is charging, defibrillator
will automatically charge to the new energy selection. The
CHARGE button need not be pressed again to select the new
energy level.
•
Disconnect from the patient any medical electronic device
that is not labeled “defibrillation protected.”
•
Before charging the defibrillator, verify that the energy
selected on the display is the desired output.
•
Some erythema of the skin and/or minor burns may occur
during defibrillation. Use proper defibrillation techniques, as
outlined in the User Instruction Manual, to minimize
erythema/burns.
•
Defibrillation will take priority over external pacing. Should
the defibrillator be charged during the administration of
external pacing, the pacer will automatically be turned off
and the defibrillator will charge to the selected energy.
•
Transcutaneous pacing should not be used to treat V FIB
(ventricular fibrillation). In cases of V FIB, immediate
defibrillation is advised.
•
Transcutaneous pacing may cause discomfort ranging from
mild to severe, depending on the patient’s tolerance level,
muscle contractions and electrode placement. In certain
cases, discomfort may be decreased by slightly relocating the
pacing pads.
•
It is important to monitor the patient closely to verify that
both mechanical and electrical capture are occurring.
Electrical capture can be verified by observing the presence
of a large ectopic beat after the pacing pulse is delivered. The
size and morphology of the beat are dependent on the patient.
In some instances the beat may appear as a relatively normal
looking QRS pulse. Mechanical capture can be verified by
checking for signs of increased blood flow i.e., reddening of
AFETY INFORMATION
([WHUQDO3DFLQJ3UHFDXWLRQV
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
1.11
S
the skin, palpable pulses, increased blood pressure, etc. (See
chapter 8). Continuously observe the patient during pacing
administration, to insure capture retention. Do not leave the
patient unattended when administering external pacing
therapy.
•
Some erythema of the skin and/or minor burns may occur
under the pacing electrodes in some patients. For prolonged
periods of pacing (>4 hours), periodically inspecting the skin
beneath the electrodes (when patient’s condition allows) is
recommended. Discontinue external pacing if the skin is
affected and if another form of pacing is available.
•
Disposable defibrillation/pacing electrodes must be used in
accordance with the manufacturer’s instructions. Do not use
expired, dry electrodes or reuse disposable electrodes, as
improper patient contact may result in patient burns and
inability of the device to function properly.
•
The pacing rate determination can be adversely affected by
artifact. If the patient’s pulse and the heart rate display are
significantly different, external pacing pulses may not be
delivered when required.
•
WARNING: PACEMAKER PA TIENTS
. The W elch Allyn
PIC includes a pacemaker rejection circuit. The following
warning is in accordance with the disclosure requirement of
AAMI Standard EC-13-3.1.2.1 (8): The rate meter may
continue to count the pacemaker rate during some
occurrences of cardiac arrest or some arrhythmias. Do not
rely upon the heart rate meter alarms to assess the patient’s
condition. Keep pacemaker patients under close surveillance.
Note: This warning is an AAMI requirement that applies to
all ECG monitors, regardless of make or model.
•
Artifact and ECG noise can make R-wave detection
unreliable, affecting the HR meter and the demand mode
pacing rate. Always observe the patient closely during pacing
operations. Consider using asynchronous pacing mode if a
reliable ECG trace is unobtainable.
AFETY INFORMATION
1.12
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
S
•
Keep the Welch Allyn finger probe clean and dry.
•
SpO2 measurements may be affected by certain patient
conditions: severe right heart failure, tricuspid regurgitation
or obstructed venous return.
•
SpO2 measurements may be affected when using
intravascular dyes, in extreme vasoconstriction or
hypovolemia or under conditions where there is no pulsating
arterial vascular bed.
•
SpO2 measurements may be affected in the presence of
strong EMI fields, electrosurgical devices, IR lamps, bright
lights, improperly applied sensors; the use of non-Welch
Allyn sensors, or damaged sensors; in patients with smoke
inhalation, or carbon monoxide poisoning, or with patient
movement.
•
Tissue damage can result if sensors are applied incorrectly, or
left in the same location for an extended period of time. Move
sensor every 4 hours to reduce possibility of tissue damage.
•
Do not use any oximetry sensors during MRI scanning. MRI
procedures can cause conducted current to flow through the
sensors, causing patient burns.
•
Do not apply SpO
2
sensor to the same limb that has an NIBP
cuff. The SpO
2
alarm may sound when the arterial circulation
is cut off during NIBP measurements, and may affect SpO
2
measurements.
•
WARNING
: In some instances, such as obstructed airway,
the patient's breathing attempts may not produce any air
exchange. These breathing attempts can still produce chest
size changes, creating impedance changes, which can be
detected by the respiration detector. It is best to use the pulse
oximeter whenever monitoring the respirations, to accurately
depict the patient's respiratory condition.
AFETY INFORMATION
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WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
1.13
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•
Only a physician can interpret pressure measurements.
•
Blood pressure measurement results may be affected by the
position of the patient, his or her physiological condition and
other factors.
•
Substitution of a component different from that supplied by
Welch Allyn (e.g., cuff, hoses, etc.) may result in
measurement error. Use only Welch Allyn cuffs and hoses.
•
Do not use a blood pressure cuff on the limb being used for
IV infusion or for SpO
2
monitoring.
•
Accurate pressure readings may not be achieved on a person
experiencing arrhythmias, shaking, convulsions or seizures.
Medication may also affect pressure readings. The correct-
size cuff is essential for accurate blood pressure readings.
•
Blood pressure hoses must be free of obstructions and
crimps.
•
If the patient’s cuff is not at heart level, an error in
measurement may result.
•
When monitoring blood pressure at frequent intervals,
observe the cuffed extremity of the patient for signs of
impeded blood flow.
•
WARNING
: THIS DEVICE IS NOT APPROVED FOR
USE ON NEO-NATAL PATIENTS.
•
Do not monitor one patient’s NIBP while monitoring another
patient’s ECG.
•
Blood pressure measurement may be inaccurate if taken
while accelerating or decelerating in a moving vehicle.
•
If an NIBP measurement result is questionable or “motion”
indication is displayed, repeat the measurement. If the
repeated measurement result is still questionable, use another
blood pressure measurement method.
•
Do not use the NIBP on cardiopulmonary bypass patients.
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AFETY INFORMATION
1.14
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
S
•
Use only Welch Allyn SmartPak or Welch Allyn SuperPac
batteries in the W elch Allyn PIC. Use of any other battery can
damage the Welch Allyn PIC and not provide sufficient
power, inhibiting patient care.
•
If the Low Battery indication occurs at any time during
operation, immediately replace the battery pack with a
battery pack known to be fully charged. Always have a fully
charged battery pack available as a back-up.
•
Due to the critical nature of all batteries, replacement of the
Welch Allyn batteries is recommended at 24-month intervals.
•
Proper care and maintenance of the Welch Allyn batteries is
important to ensure continuous operation during patient care.
If the batteries are not maintained properly, loss of power
during patient care could result, affecting patient care.
•
The battery packs contain materials such as stainless steel,
cadmium and nickel, which can be recycled. They must be
disposed of properly. Consult local authorities for proper
disposal.
AFETY INFORMATION
%DWWHU\3UHFDXWLRQV
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
1.15
&KDUJHU3UHFDXWLRQV
•
Charge only Welch Allyn SmartPak or SuperPac batteries in
the Welch Allyn Quick Charger/Conditioner. Charging any
other battery can cause damage to the Quick Charger.
•
Do not insert objects into or block the charger’s ventilation
ports.
•
When testing the defibrillator on the charger’s defibrillation
output tester, ensure that the paddle surface is positioned
properly in the paddle test well. Do not use gel during this
test, and ensure that the paddle surface is not contacting the
metal charger frame. When discharging the paddles into the
tester, press the paddles firmly into the test well to prevent
pitting the paddle surfaces.
•
Only test Welch Allyn defibrillators on the charger’s
defibrillation output tester. Testing other brands of
defibrillators will damage the charger’s defibrillation output
tester.
•
Do not take charger or paddle holder apart or attempt to
repair it yourself.
•
The Welch Allyn charger should not be used in the presence
of flammable anesthetics or materials.
•
If the charger has been dropped or shows visible signs of
abuse, refer device to qualified service personnel for
verification of proper operation.
•
Do not immerse the charger or expose it to water or other
liquids.
•
Wipe only the outside with a damp cloth.
•
Tighten clamp onto power cord to prevent its accidental
removal.
•
Unplug the charger prior to changing the fuse.
•
Use only the W elch Allyn Quick Char ger to power the Welch
Allyn PIC System from an auxiliary power source.
•
Do not use the Welch Allyn Quick Charger to power any
non-Welch Allyn devices.
•
A depleted battery could increase defibrillator charge times.
•
It is recommended that a fully charged battery be inserted in
the PIC System even when operating on auxiliary power.
S
AFETY INFORMATION
NOTE:The PIC System will operate from an auxiliary power source
without a battery inserted or if the inserted battery is depleted.
However, under these circumstances, defibrillator charge time
will be slightly longer (10 seconds typical, 15 sec. maximum).
1.16
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
S
•
WARNING: Cardiac Pacemakers
. The presence of an
internal cardiac pacemaker may adversely affect analysis
results. If it is known, or suspected, that the patient is fitted
with a cardiac pacemaker, follow your own locally-
established procedure for dealing with defibrillation of such
patients.
•
The PIC, in SAED mode, should only be applied to victims
of cardiac arrest who exhibit unconsciousness, absence of
breathing, and absence of pulse.
•
Excessive motion may affect analysis results. ECG analysis
should not be performed when the patient is being moved.
Stop all patient movement and do not touch patient when the
ECG analysis is in process. Take precautions to eliminate
sources of motion or artifact before monitoring in SAED
mode.
•
To insure compatibility and electrical safety, accessory
pressure sensors should comply with ANSI/AAMI BP-22 and
IEC 601-2-34 for IBP or ANSI/AAMI NS28 for ICP
•
Follow instructions supplied with any accessory pressure
sensor regarding calibration and removal of trapped air.
•
Avoid touching metal parts of any transducer while it is in
contact with the patient.
•
Do not reuse any components that are labeled for single use
only.
•
Transducers should be rated to withstand an accidental drop
of at least a meter onto a hard surface.
•
Transducers that are subject to immersion in liquids should
be rated as watertight.
AFETY INFORMATION
6$('3UHFDXWLRQV
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WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
1.17
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•
Do not use CO
2
sensor during MRI scanning. MRI
procedures can permanently damage the CO
2
sensor.
•
CO2/ETCO
2
measurements may be affected by the presence
of interfering gases or vapors. Do not use on a patient being
administered oxygen or nitrous oxide.
•
Use only Welch Allyn CO
2
sensors and adapters.
•
Do not reuse airway adapters that are labeled for single
patient use.
•
Prior to using airway adapter check for lodged obstructions.
After attaching, check the sensor for proper placement of the
sensor.
•
If using the CO
2
Monitor for extended critical care, replace
the airway adapter every 24 hours or when it becomes
occluded.
•
Do not use with patients with a low tidal volume, such as
patients younger than 3 years of age or weighing less than
22 pounds, or patients with a respiration rate greater than or
equal to 60 breaths per minute.
•
Accuracy is based upon 1 atmospheric pressure and no
residual CO
2
gas left in the sensor from previous expiration.
The CO
2
trace will be displayed as if that is the case.
S
AFETY INFORMATION
1.18
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
HAPTER
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This chapter introduces the Welch Allyn Portable Intensive Care (PIC) System beginning
2: I
NTRODUCTION
with a brief listin
numbers and checklists of available options and accessories. The chapter concludes with
procedures and considerations for unpackin
Chapter Overview:
of features and benefits. This is followed by an explanation of the part
, installing, and operating the system.
• Product Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2
• Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.4
• Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.6
• Options and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .2.7
• Initial Installation Evaluation. . . . . . . . . . . . . . . . . . . . . . . . .2.9
• Summar
of Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.11
Welch Allyn Portable Intensive Care (PIC) System
W
ELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
2.1
3URGXFW2YHUYLHZ
The Welch Allyn Portable Intensive Care (PIC) System is an
extremely flexible device that incorporates an ECG monitor,
defibrillation (manual and semi-automated), external pacer, pulse
oximeter, non-invasive blood pressure, and respiration monitoring.
The PIC System’s small, lightweight package makes it ideal for
transport situations, and it has been designed for use in and out of the
hospital.
•
Flexible design
•
Small, lightweight
•
Pulse oximetry and NIBP options available
•
Large (6.5") bright, easy-to-read display
•
Three simultaneous traces
•
Treatment Summary documentation
•
Voice Memo
TM
storage and retrieval
•
Card review
•
User-configurable options
•
Simple menus
•
Hands-free defibrillation
•
Mains (AC) and battery power capability
•
Upgradable for future expansion
The PIC has been designed to allow additional monitoring options to
be installed anytime in the future. System can grow with your needs.
Weighing only 10 pounds, and not much larger than a cardiac
monitor, this full-function intensive care tool is ideal for
transport/portable applications.
g
Using surface mount component technology, miniaturization allows
pacing, pulse oximetry, NIBP, respiration, and temperature to be
added in the same small package as the ECG monitor and
defibrillator.
y
A large, bright display allows viewing the critical parameters from
across the room and from any angle.
Key Features
I
NTRODUCTION
Flexible Design
Small, Lightweight
Multiparameter
Monitorin
Large, Bright Displa
2.2
WELCH ALLYN PORTABLE INTENSIVE CARE SYSTEM
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