3
Installing Easy Software
Refer to the Easy III Software Installation guide (PN# 369031-034) to
install Easy III.
Obtaining a Software Key
If you are installing the Easy software on a computer, you will need to obtain
a unique System Key number from Cadwell Laboratories to unlock the Easy
software. A software control panel will be automatically displayed the first time
you try to run the Easy Program, please call or fax Cadwell Laboratories and
provide the displayed System ID number along with the Serial number of the
computer, Easy amplifier, or your Cadwell Customer Number. Cadwell will then
issue you a System Key number that will unlock the Easy program and activate
the appropriate software options.
Minimum Computer Requirements
Performance requirements:
Refer to Cadwell document 308014-000 for minimum computer requirements.
US & Canada:
Computer and information technology equipment connected to the Easy
Ambulatory must be third party certified to UL1950 or IEC950.
European Union:
Computer and information technology equipment connected to the Easy
Ambulatory must be third party certified to EN60950.
Service and Repair
A technical manual is available allowing qualified technical personnel to
verify proper operation and to troubleshoot board level problems. If you have
any questions, please call Cadwell at 800-245-3001 within the United States.
International customers please contact your local distributor or call Cadwell at
800-245-3001.
Regulatory Approvals
UL 60601-1 2003
CSA 601.1 1990
EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996
EN 60601-1-1:2001 (medical systems)
EN 60601-2-26:2002 (EEG equipment)
EN 60601-1-2:2002 (EMC)
EN 60601-1-4:2000 (programmable electrical medical systems)
EN ISO 14971:2000 (risk)
Notified Body: KEMA Medical
0344
Intended Use
The Easy Ambulatory system is intended for use by a physician or trained
technician under the supervision of a physician for the acquisition of EEG and
other polygraphic channels. The intended recording environment for the Easy
Ambulatory is the home, hospital, and other testing environments.
Copyright Notice
Cadwell Laboratories, Inc, reserves the right to modify, delete, extend
or improve features described herein without notice. ©2010. Cadwell
Laboratories, Inc. All rights reserved.
Trademark Notices
Cadwell, Easy, EasyNet and EasyHub are trademarks or registered trademarks of
Cadwell Laboratories, Inc.
Warnings, Cautions
Federal law restricts sale of this system to, or on the order of, a
physician.
High levels of static discharge can cause a momentary pause in data
collection.
No user serviceable parts inside. Service by Cadwell Laboratories, Inc.
and other authorized bodies only.
Inspect EasyNet cables before and after each use. Discard cable if
insulation is damaged or if the cable or connectors are damaged in
any manner.
Inspect battery cable before and after each use. Discard cable if
insulation is damaged or if the cable or connectors are damaged in
any manner.
Do not immerse the recorder in liquid. Do not attempt to use the
Ambulatory system if it has been immersed in liquid. The system is not
water resistant or splash proof. The contact of liquids with the internal
parts and connectors of the Cadwell Easy Ambulatory system should
be avoided at all times.
Caution must be taken to ensure that cables do not encircle the
patient’s neck or entangle the patient in any way.
The operator must be trained to be able to recognize the difference
between signal artifact and valid bio-signals caused by movements,
interference, or misplacement of sensors or electrodes.
The system is not defibrillator proof.
Do not use the system in an MRI environment.
Cleaning instructions in this manual need to be strictly adhered to.
When applying the stockinet to the patient, verify that the stockinet
is not covering the patient’s eyes, nose, mouth, or ears. Verify that
the stockinet does not entangle the patient’s neck, restrict airflow, or
restrict circulation.
When attaching the Easy Ambulatory system to a recording subject,
verify that the subject will not become entangled in the wires. Do not
allow the electrode wires to wrap around the subject’s neck. Instruct
the patient in the proper way to wear the Easy Ambulatory system and
not become entangled.
The system is not designed to operate in an explosive environment.
Setup Verification
Follow the instructions in the setup verification procedure (PN# 100830-935)
that was shipped with this system.