GE 2059146 Benutzerhandbuch

DIRECT-WIRED DISPOSABLE
DEFIBRILLATION/PACING ELECTRODES
Description
Direct-wired disposable defibrillation/pacing electrodes
are:
• used for external defibrillation/pacing in
connection with a GE Healthcare defibrillator
device (see table 1)
• available as a pair of 2 electrodes in sizes for
adults and pediatrics
• Class IIb medical devices according to 93/42/
EEC for Europe and Class III per 21 CFR
870.5310 for U.S.A.
• replacements for disposable posted and prewired
style electrodes including their adapter cables
(see table 1)
Intended Use
The direct-wired disposable defibrillator electrodes
are applied to the patient's torso and will be used to
administer cardiac defibrillation shock and pacing
when medically indicated.
These devices are intended for trained operators
under direct supervision of a licensed healthcare
practitioner on adult and pediatric patients.
The electrodes are compatible with following GE
defibrillator devices: CardioServ, Dash Responder,
Responder 3000, Responder 2000 and Responder
1100.
Purpose of Document
This document contains the Intended Use, safety
information and Instructions for Use for direct-wired
disposable defibrillation/pacing electrodes.
Hazards
DANGER
Do not operate the electrodes in the presence of
flammable gases (including concentrated oxygen) and
solvents to avoid possible explosion or fire hazard.
WARNING
- Not following these instructions or any other
misuse or misapplication of any electrode may
result in patient burns or ineffective therapy.
(Note: Reddening of skin is normal.)
- Use with GE Medical Systems Information
Technologies, Inc. equipment (see table 1). Use
of this product with any unspecified device may
result in potentially hazardous connection.
GE ITEM No.: 2059146 - 001 B
REF
English
- Strangulation Hazard — Route cables and tubes
away from patient's throat to avoid possible
strangulation.
- Noninvasive pacing may cause skin irritation
or burns. Use caution and inspect skin every
30 minutes during continuous pacing. Replace
electrodes after 1 hour of continuous pacing.
Extensive pacing may lead to air bubbles. To
ensure optimal contact smooth out bubbles by
hand.
For adults:
- For use only for patients above 25 kg / 55 lbs
body weight.
- Replace electrodes after 50 defibrillation shocks,
1 hour of continuous pacing* or 24 hours on skin.
For pediatrics:
- For use only for children below 25 kg / 55 lbs
body weight.
- Do not exceed 100 Joule while defibrillating.
- Use local protocol or American Heart Association
guidelines to select appropriate defibrillation
energy level corresponding to patient's body
weight.
- Replace electrodes after 25 defibrillation shocks,
1 hour of continuous pacing**, or 8 hours on skin.
CAUTION
- Check expiration date prior to use. Do not use if
product is expired.
- Do not crush, bend or fold electrodes or store
them under heavy objects.
- Ensure patient's chest is clean and dry.
- Do not open pouch until ready for use.
- Inspect for integrity of pouch, electrode, cable
and connector prior to use. Do not use, if
compromised.
- Use electrodes within 1 day once pouch has
been opened.
- Do not use, if gel is dry.
- Do not use additional gel on electrodes.
- Do not overlap defibrillation electrodes.
- Keep defibrillation electrodes clear of any other
electrodes or metal parts in contact with patient.
Avoid electrode placement above an internal
pacemaker.
- Do not reposition electrodes.
- Use separate ECG electrodes and cable when
performing non-invasive pacing.
- Do not touch patient during defibrillation.
- Do not discharge hand-held paddles through
these electrodes.
- Do not re-use the defibrillation electrodes.
If re-used, the electrical properties might be
insufficient, which could lead to a patient injury/
hazard.
- These electrodes are single-patient use. Reuse
1