HeartSine 350P Connected Samaritan PAD User Manual

: July 15, 2024
: HeartSine

Table of Contents

HeartSine 350P Connected Samaritan PAD
FAQ
Product Usage Instructions
- US
- UK
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

HeartSine 350P Connected Samaritan PAD

Specifications:

Battery capacity: >60 shocks or 6 hours battery use
Intended purpose: Contains the battery to power the HeartSine\ samaritan PAD and two electrode pads for defibrillation

Product Usage Instructions

Set-up:

Remove the product from packaging.
Place the HeartSine samaritan PAD (AED) face up on a flat surface and slide in the Pad-Pak or Pediatric-Pak.
Listen for a double click to indicate proper insertion.
Verify that the green status indicator is blinking, indicating\ readiness for use.
Turn on the AED. Ensure you hear the expected language and no warning message. Turn off the AED when finished.

Disposal after Use:

Dispose of pads as infectious waste. Recycle the lithium battery separately according to local regulations.

Warnings:

DO NOT USE if expiry date is exceeded.
DO NOT USE if the pouch is opened or damaged, as this may result in dry electrode gel.
Single use ONLY to avoid therapy delivery failure and cross-infection.
DO NOT PULL the green tab on the Pad-Pak during set-up.
If a warning message is heard when turning on the AED, consult the user manual for troubleshooting steps.

Cautions:

Avoid reusing to prevent therapy delivery failure and\ cross-infection. Follow disposal instructions for safe handling.

Indications for Use:

The Pad-Pak and Pediatric-Pak are indicated for use on victims of cardiac arrest when used with the HeartSine samaritan PAD. Refer to the AED user manual for specific signs of cardiac arrest.

Additional Information:

For full instructions, contraindications, safety information,\ and disposal instructions, refer to the HeartSine samaritan PAD user manual available at heartsine.com.

FAQ

Q: What should I do if I hear a warning message when turning on the AED?

A: Consult the troubleshooting section of the HeartSine Samaritan PAD user manual for guidance on addressing warning messages.

Product Usage Instructions

US

Set-up

Remove from packaging.
Place HeartSine samaritan PAD (AED) face\ up on a flat surface and slide in Pad-Pak or\ Pediatric-Pak.
Listen for “double click” to indicate it is properly inserted.
Verify that green status indicator is blinking, indicating the AED is ready for use.
Turn on AED. You should hear expected language and should not hear a warning message. Turn off AED.

Disposal after use

Remove Pad-Pak. Cut wires. Stick pads together. Dispose of pads as infectious waste. Recycle lithium battery separately per local regulations

Pad-Pak and Pediatric-Pak contain:

Pair of disposable single use defibrillation pads
LiMnO2 (18V – 1500mAh) non-rechargeable battery

Indications for use

The Pad-Pak and Pediatric-Pak, when used with a HeartSine samaritan PAD, are indicated for use on victims of cardiac arrest. See the AED user manual or user handbook for the exhibiting signs of cardiac arrest specific to each device.

Pad-Pak: Intended for use on adults or children
- 8 years or > 25 kg (55 lb)
Pediatric-Pak: Intended for use on children between the age of
- 1-8 years or < 25 kg (55 lb)

Battery capacity

60 shocks or 6 hours battery use.

Warnings

DO NOT USE if expiry date is exceeded.
DO NOT USE if the pouch is opened or damaged.
This may result in the electrode gel being dry.

Cautions

Single-use ONLY. Reuse may cause AED to be unable to deliver therapy leading to a failure to resuscitate. It may also lead to cross-infection between patients.
DO NOT PULL the green tab on the Pad-Pak during

set-up.

If you hear a warning message when you turn on your HeartSine samaritan PAD, consult the troubleshooting section of the HeartSine \samaritan PAD user manual or user handbook. For full instructions for use, indications for use, contraindications and safety information, and disposal instructions refer to your HeartSine\ samaritan PAD user manual or user handbook. Each can be found at heartsine.com.

Notes

Pediatric-Pak is only suitable for use with HeartSine samaritan PADs with the symbol
The TSO/ETSO-certified Pad-Pak must be used on board commercial fixed-wing aircraft
DO NOT STORE the Pediatric Pak next to magnetically sensitive storage media as it contains a magnetic component (surface strength 6500 gauss)

Please report any serious incident that occurs with this device to HeartSine Technologies, Ltd. and to the U.S. Food and Drug Administration as per local regulations.

UK

Set-up

Remove from packaging.
Place HeartSine samaritan PAD (AED) face up on a flat surface and slide in Pad-Pak or Pediatric-Pak.
Listen for “double click” to indicate it is properly inserted.
Verify that green status indicator is blinking, indicating the AED is ready for use.
Turn on AED. You should hear expected language and should not hear a warning message. Turn off AED.

Disposal after use

Remove Pad-Pak. Cut wires. Stick pads together. Dispose of pads as infectious waste. Recycle lithium batteries separately per local regulations

Pad-Pak and Pediatric-Pak contain:

Pair of disposable single-use defibrillation pads
LiMnO2 (18V – 1500mAh) non-rechargeable battery

Intended purpose

The Pad-Pak or Pediatric-Pak accessory contains the battery to power the HeartSine samaritan PAD and two electrode pads to provide the electrical connection to the patient’s chest for delivery of defibrillation shock. The delivery of a defibrillation shock can stop disruption to the heart’s normal rhythm and restore blood flow.

Indications for use

The Pad-Pak and Pediatric-Pak, when used with the HeartSine samaritan PAD, are indicated for use on victims of cardiac arrest who are exhibiting the following signs: unconscious, not breathing and without circulation.

Pad-Pak: Intended for use on adults or children
- 8 years or > 25 kg (55 lb)
Pediatric-Pak: Intended for use on children between the age of
- 1-8 years or < 25 kg (55 lb)

Contraindications

Do not use if the patient is responsive or conscious.

Battery capacity

60 shocks or 6 hours of battery use.

Warnings

DO NOT USE if the expiry date is exceeded.
DO NOT USE if the pouch is opened or damaged.
This may result in the electrode gel being dry.

Cautions

Single-use ONLY. Reuse may cause AED to be unable to deliver therapy leading to a failure to resuscitate. It may also lead to cross-infection between patients.
DO NOT PULL the green tab on the Pad-Pak during set-up.
If you hear a warning message when you turn on your HeartSine samaritan PAD, consult the troubleshooting section of the HeartSine\ samaritan PAD user manual or user handbook. For full instructions for use and safety\ information refer to your HeartSine samaritan PAD user manual or user handbook. Each can be found at heartsine.com.

Notes

Pediatric-Pak is only suitable for use withHeartSine samaritan PADs with the symbol
The TSO/ETSO-certified Pad-Pak must be used on board commercial fixed-wing aircraft
DO NOT STORE the Pediatric-Pak next to magnetically sensitive storage media as it\ contains a magnetic component (surface strength 6500 gauss)

Symbol

Please report any serious incident that occurs with this device to HeartSine Technologies, Ltd. and to your national competent authority or other local regulatory authority as per local regulations.

HeartSine Technologies, Ltd.
207 Airport Road West
Belfast
Northern Ireland
BT3 9ED
United Kingdom
Tel +44 28 9093 9400
Fax +44 28 9093 9401
Distributed in U.S. by:
Stryker Emergency Care
11811 Willows Road NE
Redmond, WA, 98052 U.S.A.
Toll Free 866 478 7463
Tel +1 215 860 8100
Fax +1 215 860 8192
heartsine.com
heartsinesupport@stryker.com

Stryker Australia Pty Ltd 8 Herbert St St Leonards NSW 2065 Australia Stryker European Operations B.V. Herikerbergweg 110 1101 CM Amsterdam Netherlands