PHILIPS IntelliVue Reusable ECG Lead Sets and Trunk Cables Instruction Manual

IntelliVue Reusable ECG Lead Sets and Trunk Cables
Instruction Manual

IntelliVue Reusable ECG Lead Sets and Trunk Cables

IntelliVue Reusable ECG Lead Sets and Trunk Cables
Instructions for Use

• Indicates products approved for use in Operating Room (OR) environments.  

INDICATIONS FOR USE

Philips IntelliVue reusable ECG lead sets and trunk cables are limited by the indications for use of the connected monitoring and diagnostic equipment, and are for use only by healthcare professionals. They are designed for multiple patient use and indicated for monitoring cardiac signals for both diagnostic and monitoring purposes in adult, pediatric, and neonatal patients.
Philips operating room (OR) ECG trunk cables are indicated for use to monitor patient ECG in an electrosurgery (ESU) environment when used in combination with a compatible ECG patient lead set on adult, pediatric, infant, and neonatal ECG applications.

DESCRIPTION

Tables on pages 1- 2 define physical characteristics and applications for all ECG lead set and trunk cable products included in this IFU. A descriptive key to all column
headings within those tables is provided below.

AAMI| Check mark indicates that the lead set is
AAMI color coded.
---|---
IEC| Check mark indicates that the lead set is
IEC color coded.
3 ECG
4 ECG
5 ECG
6 ECG| Indicates the total number of ECG leads in each lead set, and the type of electrode connector at the end of each lead:
= Grabber
= Snap
= Mini Clip
= DIN (each DIN lead requires an electrode connector adapter 989803193821).
| Identifies length(s) of lead set leads, or trunk cable.
| Check mark ✓ identifies lead sets that are appropriate for chest application.
| Check mark ✓ identifies lead sets that are appropriate for arm/leg application.
| Check mark ✓ identifies lead sets and/or trunk cables that may be used in operating room environments.
| Check mark ✓ identifies lead sets that require electrode connector adapters. One adapter ( 989803193821) is needed for each DIN lead. See WARNINGS section.
| Defines the lead set or trunk cable catalog reference number.
AAMI + IEC
(x) or (x-x)| Defines ECG trunk cables as being both AAMI and IEC compatible, with (x) or (x-x) identifying each trunk cable’s lead set connector pin configuration.

COMPATIBILITY

IntelliVue ECG lead sets and trunk cables can be used with any ECG monitor or defibrillator for which they are listed as accessories in that product’s IFU.

DISPOSAL

Follow approved medical waste disposal methods as specified by your patient care facility or local regulations.

WARNINGS

• Leads that have DIN electrode connectors require a separate electrode connector adapter for each lead. For more information reference the Reusable Electrode Adapter Instructions for Use.
• Refer to the IFU for the monitor/defibrillator for additional warnings and cautions.
• Refer to the IFU for the monitor/defibrillator for  information regarding proper lead/electrode placement that complies with standard AAMI or IEC practices.
• Ensure that the patient is properly grounded during ESU procedures.
• Do not use ECG leads and cables in magnetic resonance imaging (MRI) environments or during MRI procedures.
• Ensure that ECG leads and cables are carefully positioned to avoid entanglement, choking, and strangulation.
• When used to monitor ECG in the OR, ensure that you use accessories that provide appropriate ESU protection (orange OR lead sets, or ICU lead sets paired with Philips OR trunk cables 989803170171 or 989803170181).
• OR lead sets and/or OR trunk cables cannot be used to measure respiration.

CAUTIONS

• Do not use if visual inspection reveals damage or contamination.
• Do not use lead sets/cables in excessively wet environments.
• Ensure that the trunk cable is properly plugged into the monitor/defibrillator and lead set.

CLEANING AND DISINFECTION

Lead Set and Trunk Cable Cleaning
To reduce risk of cross-infection, always clean and disinfect the product before applying it to a different patient.
Modestly dampen a lint-free cloth with one of the approved cleaning/disinfecting agents listed in the table that follows and gently wipe all cable and connector
surfaces. After cleaning, wipe the outside surfaces of the cable/leads/connectors with a clean lint-free cloth dampened with clean water.
Note: Do not immerse the trunk cable connectors or lead set connectors in any fluid.
Note: Follow the manufacturer’s instructions regarding duration of cleaner application.
DIN Electrode Connector Adapter Cleaning
Approved cleaning and disinfecting agents and instructions for cleaning the DIN electrode connector SYSympackaging
adapter are provided in the Reusable Electrode Adapter Instructions for Use.

STERILIZATION

Lead Set and Trunk Cable Sterilization
Use Ethylene Oxide (EtO) sterilization only. Follow all safety precautions regarding aeration after EtO exposure.
DIN Electrode Connector Adapter Sterilization
Reference the Reusable Electrode Adapter Instructions for Use.

Isopropanol|
---|---
Bacillol® AF|
Bacillol® 25|
Meliseptol®|
Accel TB RTU|
Oxivir® Tb Cleaner Disinfectant|
Oxivir® Tb Wipes|
Carpe DiemTM/MC Tb|
Super Sani-Cloth|
SANI-CLOTH® PLUS Germicidal Disposable Wipes|
SANI-CLOTH® HB Germicidal Disposable Wipes|
Hexanios G+R|
Sodium hypochlorite, bleach|
Surfanios Citro|

= Approved cleaner/disinfectant.
= Cleaning/disinfecting agent is known to cause damage to plastic material and should be avoided, if possible. After cleaning/disinfecting, ensure that all residue is removed by wiping the surface using a clean lint-free cloth dampened with clean water.
Trademark indicator or® TM/MC defines a trademarked product name of the respective manufacturer.

SYMBOL DEFINITIONS

Symbols that may appear on products or product packaging are defined below.

| Quantity per pouch
---|---
| Refer to Instruction Manual/Booklet
| Attention, consult accompanying documents
| Consult Instructions for Use
| Defibrillation proof type CF Applied Part
| Prescription use only
| Not manufactured with natural rubber latex
| Storage temperature range
| Atmospheric pressure limits
| Humidity limits
IPX3| Ingress protection per IEC 60529

To locate your local Philips sales office, visit www.healthcare.philips.com or contact a Philips regional office listed below.

United States:
Philips Healthcare
North America Corporation
3000 Minuteman Road
Andover, MA 01810-1099
+1 800 225-0230 toll free
Canada:
Philips Healthcare Canada
281 Hillmount Road
Markham, ON L6C 2S3
800-291-6743
Latin America Headquarters:
Philips Healthcare Brazil
Rua Verbo Divino, 1400 – 7° andar
Chacara Santo Antonio
São Paulo, SP 04719-002 Brazil
Tel: +55 11 2125 0744 Fax: +55 11 2125 0761
Europe, Middle East, and Africa:
**Philips Medizin Systeme
Böblingen GmbH
Hewlett-Packard Str. 2
71034 Böblingen, Germany
Tel: (+49) 7031 463 2254 Fax: (+49) 7031 463 1552
Asia Pacific Headquarters:
Philips Electronics Singapore Private Limited
Philips Healthcare
620A Lorong 1 Toa Payoh
Singapore 319762
Tel: 1-800-PHILIPS Fax: +65 6255 4853
989803170171, 70181, 92181, 92191, 92211, 92201, 92221, 92231, 92241, 92251
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810-1099, USA
All other lead set and trunk cable product part numbers in this document that are not listed above.
Philips Medizin Systeme
Böblingen GmbH
Hewlett Packard Str. 2
71034 Böblingen, Germany
** For more information or to reorder, go to
www.philips.com/healthcarestore.
Subject to modification
Copyright © 2014
Koninklijke Philips N.V.
September 2014 Edition
All rights reserved
IFU Part No. 453564484201
A-453564484201-2 Rev. A
Stryker Internal Control No.: EL10049 Rev A

References

• Philips - Location selector
• Resource center | Philips
• Philips Healthcare Store for Professionals | Anonymous Homepage

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