Ref 9515-XXX-XX-ENG Rev A1 WIRELESS ACQUISITION MODULE WAM™ USER MANUAL Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
® Copyright © 2009 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224 This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. WAM (Wireless Acquisition Module) will is a trademark of Mortara Instrument, Inc. V1.
Technical Support and Service Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com European Union Representative Mortara Rangoni Europe, Srl (European Headquarters) Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Italy Tel: +39.051.298.7811 Fax: +39.051.613.3582 Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.
Notices Manufacturer’s Responsibility Mortara Instrument, 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 Mortara Instrument, Inc. • 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.
Warranty Information Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Product/s”) shall be free from defects in material and workmanship under normal use, service, and maintenance for the warranty period of such Product/s from Mortara or an authorized distributor or representative of Mortara.
User Safety Information Warning: Means there is the possibility of personal injury to you or others. Caution: Means there is the possibility of damage to the device. Note: Provides information to further assist in the use of the device. Warning(s) · This manual gives important information about the use and safety of this device.
other adverse reactions. Electrodes are intended for short term use and should be removed from the patient promptly following testing. · 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. · A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
Caution(s) · To prevent possible damage to the device, do not use sharp or hard objects to depress buttons, only use fingertips. · Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam cleaning as this may damage equipment or reduce its usable life.
· This device is intended to be used in a hospital or doctor’s office setting, and should be used and stored according to the environmental conditions specified below: Ambient Temperature Range: Relative Humidity Range: Atmosphere Pressure: 0°C to 45°C (32°F to 113°F) 5% to 95% (non-condensing) 500 hPa to 1060 hPa vii
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 FCC ID: HJR-WAM2500 These devices comply with Part 15 of the FCC rules.
Note(s) · Proper patient preparation is important to proper application of ECG electrodes and operation of the device. · If an electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged, display will indicate a lead fault for the lead(s) where the condition is present. · For additional instructions and warnings, refer to the user manual of the receiving device.
Equipment Symbols Symbol Delineation Attention, consult accompanying documents Defibrillator-proof, type CF applied part Acquire 12 Lead ECG Acquire Rhythm Print On / Off button Battery with notification: See operating instructions for type of cell to be used Indicates compliance to applicable EEC directives Do not dispose as unsorted municipal waste.
General Care Precautions · Turn off the device before inspecting or cleaning. · Do not immerse the device in water. · Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage equipment surfaces. Inspection Inspect your equipment daily prior to operation. If you notice anything that requires repair, contact an authorized service person to make the repairs. · Verify that all cables and connectors are securely seated. · Check the case for any visible damage.
Electromagnetic Compatibility (EMC) 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).
BATTERY CAP ASSEMBLY WAM 8356-008-51 xiii
Table X-1 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.
Table X-3 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.
Table X-4 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
Table of Contents INTRODUCTION SECTION 1 Manual Purpose ........................................................................................................................................ 1 Audience ................................................................................................................................................... 1 Indications for Use.....................................................................................................................................
MAINTENANCE SECTION 3 Cleaning the WAM Transmitter and ECG Cable ........................................................................................ 19 Periodic Maintenance ................................................................................................................................ 19 Disposal of Waste Materials ......................................................................................................................