Welch Allyn WAM PC User manual

Welch Allyn®
WAM™ PC
WIRELESS ACQUISITION MODULE WITH
MEMORY
USER MANUAL
Manufactured by Welch Allyn. Inc., Skaneateles Falls, NY USA
CAUTION: Federal law restricts this device to sale by or on the order of a physician.

© 2020 Welch Allyn This document contains confidential information that belongs to Welch Allyn, Inc. No
part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving
organization without the express written consent of Welch Allyn, Inc. Welch Allyn is a registered
trademark of Welch Allyn, Inc. ELI and WAM are trademarks of Welch Allyn, Inc. Adobe, Acrobat,
Microsoft, and Windows are trademarks or registered trademarks of their respective owners.
For patent information, please visit www.welchallyn.com/patents
For information about any Welch Allyn product, visit: https://www.welchallyn.com/en/about-us/locations.html
Customer Service and Technical Support: https://www.welchallyn.com/en/other/contact-us.html
1.888.667.8272, mor_tech.su[email protected].
9515-180-50-ENG Rev D
Revision date: 2020-04
EU IMPORTER
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
www.welchallyn.com
Welch Allyn Limited
Navan Business Park, Dublin Road,
Navan, Co. Meath C15 AW22
Ireland

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TABLE OF CONTENTS
NOTICES................................................................................................................................................................. 3
MANUFACTURER’S RESPONSIBILITY....................................................................................................................................3
RESPONSIBILITY OF THE CUSTOMER....................................................................................................................................3
EQUIPMENT IDENTIFICATION ............................................................................................................................................3
COPYRIGHT AND TRADEMARK NOTICES ..............................................................................................................................3
NOTICE TO EU USERS AND/OR PATIENTS:...........................................................................................................................3
OTHER IMPORTANT INFORMATION ....................................................................................................................................4
IEC CLASSIFICATION........................................................................................................................................................4
FCC COMPLIANCE STATEMENT .........................................................................................................................................4
INDUSTRY CANADA COMPLIANCE STATEMENT .....................................................................................................................4
ELECTROMAGNETIC COMPATIBILITY (EMC) ........................................................................................................... 6
GUIDANCE AND MANUFACTURER’S DECLARATION:ELECTROMAGNETIC EMISSIONS....................................................................6
GUIDANCE AND MANUFACTURER’S DECLARATION:ELECTROMAGNETIC IMMUNITY ....................................................................7
GUIDANCE AND MANUFACTURER’S DECLARATION:ELECTROMAGNETIC IMMUNITY ....................................................................8
WARRANTY INFORMATION ................................................................................................................................. 11
YOUR WELCH ALLYN WARRANTY ....................................................................................................................................11
USER SAFETY INFORMATION ............................................................................................................................... 12
EQUIPMENT SYMBOLS AND MARKINGS .............................................................................................................. 15
CARE AND MAINTENANCE ................................................................................................................................... 16
PRECAUTIONS..............................................................................................................................................................16
INSPECTION.................................................................................................................................................................16
CLEANING AND DISINFECTING.........................................................................................................................................16
INTRODUCTION ................................................................................................................................................... 17
MANUAL PURPOSE.......................................................................................................................................................17
MANUAL AUDIENCE .....................................................................................................................................................17
WAM PC DESCRIPTION................................................................................................................................................17
WAM PC WITH LEAD WIRES .........................................................................................................................................17
SPECIFICATIONS ...........................................................................................................................................................18
WAM /UTK..............................................................................................................................................................18
USING THE WAM PC ............................................................................................................................................ 19
REPLACING THE BATTERY ...............................................................................................................................................19
ATTACHING THE LEAD WIRE CONNECTOR BLOCK................................................................................................................19
TURNING THE WAM PC ON AND OFF .............................................................................................................................19
PAIRING THE WAM PC TO A UTK...................................................................................................................................19
PREPARING THE WAM PC FOR A NEW ACQUISITION..........................................................................................................19
PREPARING THE PATIENT ...............................................................................................................................................19
PREPARING THE PATIENT’S SKIN......................................................................................................................................20
ELECTRODE POSITIONS ..................................................................................................................................................21
WAM PC STATUS INDICATORS.......................................................................................................................................22
CLINICAL WORKFLOW.......................................................................................................................................... 23

TABLE OF CONTENTS
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ACQUIRING ECG WAVEFORMS.......................................................................................................................................23

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NOTICES
Manufacturer’s Responsibility
Welch Allyn, Inc. is responsible for the effects on safety and performance only if:
Assembly operations, extensions, readjustments, modifications, or repairs are carried out only by
persons authorized by Welch Allyn, Inc., and
The electrical installation of the relevant room complies with the requirements of appropriate
regulations, and
The device is used in accordance with the instructions for use.
Responsibility of the Customer
The user of this device is responsible for ensuring the implementation of a satisfactory maintenance
schedule. Failure to do so may cause undue failure and possible health hazards.
Equipment Identification
Welch Allyn, Inc. equipment is identified by a serial and reference number on the back of the device.
Care should be taken so that these numbers are not defaced.
For questions and service information, have both serial and part numbers available when calling.
The Model name (MODEL:), Serial Number (SN:), Lot Number (LOT:), Reference Number (REF:), and
FDA Unique Device Identifier (UDI) are found on the back label of the devices similar to the ones pictured
below.
Copyright and Trademark Notices
This document contains information that is protected by copyright. All rights are reserved. No part of this
document may be photocopied, reproduced, or translated to another language without prior written
consent of Welch Allyn, Inc.
Notice to EU Users and/or Patients:
Any serious incident that has occurred in relation to the device, should be reported to the manufacturer
and the competent authority of the Member State in which the user and/or patient is established.
SN: xxxxxxxxxx
REF: xxxxx-xxx-xx
(UDI) (xx)xxxxxxxxx

NOTICES
Page | 4
Other Important Information
The information in this document is subject to change without notice.
Welch Allyn, Inc. makes no warranty of any kind with regard to this material including, but not limited to,
implied warranties of merchantability and fitness for a particular purpose. Welch Allyn, Inc. assumes no
responsibility for any errors or omissions that may appear in this document. Welch Allyn, Inc. makes no
commitment to update or to keep current the information contained in this document.
IEC Classification
As defined by IEC 60601-1 and IEC 60601-2-25, the device (WAM PC) is classified as follows:
Internally powered equipment.
Type CF defibrillation-proof applied parts.
Ordinary equipment.
Equipment not suitable for use in the presence of a flammable anesthetic mixture.
Continuous operation.
FCC Compliance Statement
In the United States use of this device is regulated by the Federal Communications Commission (FCC).
The device with its antenna complies with FCC’s RF exposure limits for general population/uncontrolled
exposure.
FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the device.
WAM PC FCC ID:
HJR-WAM2500
UTK FCC ID:
HJR-UTK2500
These devices comply with Part 15 of the FCC rules. Operation is subject to the following 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.
Industry Canada Compliance Statement
These devices comply with RSS-210 of the Industry Canada rules. 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 the device.
WAM PC IC:
3758B-WAM2500
UTK IC:
3758B-UTK2500
The term “IC:” before the certification/registration number only signifies that the Industry Canada technical
specifications were met.

NOTICES
Page | 5
UL CLASSIFICATION
This device is UL classified:
WITH RESPECT TO ELECTRIC SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE
WITH UL2601-1, IEC60601-1, CAN/CSA CC22.2 No. 601.1,
AND IEC60601-2-25
WIRELESS DATA TRANSMISSION
The device is equipped with a wireless data transmission module. This technology uses radios to
transmit data to a Welch Allyn receiving application. Due to the nature of radio transmissions, it is
possible that, due to the characteristics of the environment where the device is located, some other RF
sources may interfere with the transmission generated by the device. Welch Allyn has tested the
coexistence of the device with other devices that can interfere such as devices using WLAN, Bluetooth
radio, and/or cell phones. Although the current technology allows a very successful rate of transmission,
it is possible that in some rare occurrences, the system may not perform at its best resulting in a “failed
transmission”. When this occurs, patient data will not be erased from the device nor stored in the
receiving application, ensuring that partial or corrupted data are not made available to the receiving
application. If the failure mode persists the user should move to a position where the RF signals may
propagate better and allow successful transmissions, such as in close proximity to the receiver.
ENVIRONMENTAL SPECIFICATIONS
To prevent possible damage to the device during transport and storage (while in original packaging) the
following environmental conditions must be adhered to:
Ambient Temperature Range:
-20°C to 65°C (-4°F to 149°F)
Relative Humidity Range:
5% to 95% (non-condensing)
Atmosphere Pressure:
500 hPa to 1060 hPa
This device is intended to be used in a hospital or doctor’s office setting, and should be used according to
the environmental conditions specified below:
Ambient Temperature Range:
0°C to 40°C (32°F to 104°F)
Relative Humidity Range:
5% to 95% (non-condensing)
Atmosphere Pressure:
500 hPa to 1060 hPa
DISPOSAL OF WASTE MATERIALS
The WAM PC uses one AA alkaline battery and disposable ECG electrodes. Disposal must be in
accordance with the following procedures:
Battery: applicable disposal or recycling standards
Electrodes: normal waste.

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ELECTROMAGNETIC COMPATIBILITY (EMC)
NOTE: This section applies to the WAM PC and the UTK devices when connected to a computer. This
section does not apply to the computer alone.
Electromagnetic compatibility with surrounding devices should be assessed when using the device.
An electronic device can either generate or receive electromagnetic interference. Testing for
electromagnetic compatibility (EMC) has been performed on the device according to the international
standard for EMC for medical devices (IEC 60601-1-2). This IEC standard has been adopted in Europe
as the European Norm (EN 60601-1-2).
The device should not be used adjacent to, or stacked on top of other equipment. If the device must be
used adjacent to or stacked on top of other equipment, verify that the device operates in an acceptable
manner in the configuration in which it will be used.
Fixed, portable, and mobile radio frequency communications equipment can affect the performance of
medical equipment. See the table below for recommended separation distances between the radio
equipment and the device.
The use of accessories and cables other than those specified below, may result in increased emissions or
decreased immunity of the device.
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The equipment is intended for use in the electromagnetic environment specified in the table below. The
customer or the user of the equipment should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment: Guidance
RF Emissions
CISPR 11
Group 2
The equipment must emit electromagnetic energy in order to
perform its intended function. Nearby electronic equipment may
be affected.
RF Emissions
CISPR 11
Class A
The equipment is suitable for use in all establishments other
than 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
Complies
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Complies

ELECTROMAGNETIC COMPATIBILITY (EMC)
Page | 7
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The
customer or the user of the equipment should ensure that it is used in such an environment.
Emissions Test
Compliance
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
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
Mains power quality should be that of a
typical commercial or hospital environment.
Power frequency
(50/60 Hz)
magnetic field
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.

ELECTROMAGNETIC COMPATIBILITY (EMC)
Page | 8
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The
customer or the user of the equipment should ensure that it is used in such an environment.
Emissions Test
IEC 60601 Test
Level
Compliance
Level
Electromagentic Environment: Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
150 kHz to
80 MHz
Portable and mobile RF communications equipment
should be used no closer to any part of the equipment,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
P
Vrms
d





35.3
P
mV
d





/3 5.3
80 MHz to 800 MHz
P
mV
d





/3 7
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
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:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
80 MHz to
2.5 GHz
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radios, 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 equipment is used exceeds the
applicable RF compliance level above, the equipment should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the equipment.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.