Progetti Rescue Life 9 User manual

ENG
Rev. 0.0
PROGETTI S.r.l.
Strada del Rondello, 5
10028 Trofarello (TO)
ITALY
Rev. 0.5
30/03/2022
INSTRUCTION FOR USE
Defibrillator
Rescue Life 9
Doc.N. TF-RescueLife9-0.0/3.1ENG-0.5

Rescue Life 9–Instruction For Use Rev.0.5 –30/03/2022
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Rescue Life 9–Instruction For Use Rev.0.5 –30/03/2022
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Summary
1 INTRODUCTION .......................................................................................................................1
1.1 INTENDED USE (patients group and medical conditions) ............................................................2
1.2 MEDICAL DEVICE DESCRIPTION...................................................................................................... 4
1.2.1 MAIN UNIT.........................................................................................................................................................5
1.2.2 ACCESSORIES VIEW.......................................................................................................................................... 15
1.2.3 LABELLING VIEW .............................................................................................................................................. 19
1.3 INDICATIONS............................................................................................................................... 21
1.4 CONTRAINDICATIONS.................................................................................................................. 21
1.5 GENERAL AND SAFETY INFORMATION.......................................................................................... 21
1.5.1 DANGER, WARNINGS AND CAUTIONS .............................................................................................................23
1.5.2 RESPONSIBILITY FOR INFORMATION................................................................................................................23
1.5.3 GENERAL ..........................................................................................................................................................23
1.5.4 POSSIBLE IMPROPER DEVICE PERFORMANCE .................................................................................................29
1.5.5 POSSIBLE DEVICE SHUTDOWN OR NOT SWITCHING ON .................................................................................29
1.5.6 ELECTRICAL SAFETY GUIDELINES .....................................................................................................................29
1.6 UNPACKING AND INSPECTING...................................................................................................... 30
1.7 DEVICE OPERATION AND STORAGE GUIDELINES ........................................................................... 30
1.8 CLEANING AND MAINTENANCE ................................................................................................... 31
1.9 CONNECTING TO POWER............................................................................................................. 32
1.10 BATTERY CHARGING .................................................................................................................. 35
1.11 WARRANTY............................................................................................................................... 36
1.12 SERVICE..................................................................................................................................... 36
1.13 RECYCLING ................................................................................................................................ 37
2 THERAPY .................................................................................................................................1
2.1 EXTERNAL DEFIBRILLATION............................................................................................................ 2
2.1.1 GENERAL INFORMATION FOR PROFESSIONAL USER.....................................................................2
2.1.2 INDICATIONS.............................................................................................................................. 2
2.1.3 CONTRAINDICATIONS .................................................................................................................3
2.1.4 HOW TO PREPARE THE ADULT PATIENT........................................................................................3
2.1.5 HOW TO PREPARE THE PEDIATRIC PATIENT (WITH DISPOSABLE MULTIFUNCTION ELECTRODES) .... 4
2.1.6 DEFIBRILLATION MODES.............................................................................................................4
2.1.6.1 “MANUAL” MODE (default mode)................................................................................................................. 5
2.1.6.2 “ADV” MODE ................................................................................................................................................ 12
2.1.6.3 “AED” MODE .................................................................................................................................................15
2.1.7 ESSENTIAL PERFORMANCE (Ref. EN 60601-2-4:2011) ................................................................. 22
2.2 EXTERNAL PACING (optional)....................................................................................................... 23

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3 ACQUISITION OF BIOMEDICAL PARAMETERS............................................................................1
3.1 ECG ACQUSITION ............................................................................................................2
3.1.1 ECG PATIENT CABLE CONNECTION AND ELECTRODES PLACEMENT................................................ 2
3.1.2 PROCEDURE ...............................................................................................................................2
3.1.3. ECG ALARMS SETTING ............................................................................................................... 8
3.1.4 ECG PERFORMANCE (REF. §201.7.9.2.9.101 of EN 60601-2-27:2016)............................................. 9
3.1.5 ECG essential performance (ref. en 60601-2-27:2014) ................................................................ 12
3.1.6 CAUTION (ref. 201.7.9.2.9.101 of EN 60601-2-27:2014).............................................................. 14
3.2 SpO2ACQUISITION (optional)..............................................................................................16
3.2.1 PROCEDURE ............................................................................................................................. 17
3.2.2. SpO2 ALARMS SETTING ........................................................................................................... 18
3.2.3 SpO2ESSENTIAL PERFORMANCE (ref. ISO 80601-2-61:2017)....................................................... 19
3.3 EtCO2 ACQUISITION (optional).............................................................................................20
3.3.1 PROCEDURE ............................................................................................................................. 21
3.3.2. EtCO2ALARM SETTING............................................................................................................. 24
3.3.4. Removing the EtCO2sensor kit................................................................................................. 26
3.3.5. Check before and after use ...................................................................................................... 26
3.3.6 Cleaning and Disinfection ......................................................................................................... 26
3.3.7 EtCO2module specifications ..................................................................................................... 27
3.3.8 EtCO2 ESSENTIAL PERFORMANCE (Ref. ISO 80601-2-55:2011) .................................................... 28
3.4 TEMPERATURE ACQUISITION (optional) ..............................................................................29
3.4.1 PROCEDURE ............................................................................................................................. 29
3.4.2 TEMP ALARM SETTING ............................................................................................................. 30
3.4.3 ESSENTIAL PERFORMANCE (Ref. ISO 80601-2-56:2009) .............................................................. 31
3.5 NIBP ACQUISITION (optional)..............................................................................................32
3.5.1 Introduction............................................................................................................................. 32
3.5.2 Procedure ................................................................................................................................ 33
3.5.3 WARNINGS AND PRECAUTIONS DURING THE NIBP MESURAMENT............................................. 43
3.5.4 ESSENTIAL PERFORMANCE (Ref. IEC 80601-2-30:2018)............................................................... 44
4 OTHER FUNCTIONS ..................................................................................................................1
4.1 DATA BASE............................................................................................................................2
4.1.1 FILES REVIEW ............................................................................................................................. 2
4.1.1.1 FILES COPY......................................................................................................................................................2

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4.2 PATIENT DATA LOADING........................................................................................................6
4.2.1 PROCEDURE ...............................................................................................................................6
4.3 PRINTING .............................................................................................................................8
4.3.1 AUTOMATIC PRINTING................................................................................................................9
4.3.2 MANUAL PRINTING (default setting)......................................................................................... 10
4.4 DATE AND TIME SETUP .......................................................................................................11
4.5 SYSTEM TEST ......................................................................................................................13
4.5.1 AUTO TEST ............................................................................................................................... 13
4.5.2 SHOCK TEST.............................................................................................................................. 14
4.6 SAVING AND LOADING SETUP .............................................................................................17
4.6.1 SAVE SETUP.............................................................................................................................. 17
4.6.1.1 PROCEDURE..................................................................................................................................................17
4.6.2 LOAD SETUP............................................................................................................................. 18
4.6.2.1 PROCEDURE..................................................................................................................................................18
4.6.3 DEFAULT SETUP ........................................................................................................................ 19
4.6.3.1 PROCEDURE..................................................................................................................................................19
RESCUE LIFE 9 CHECKLIST............................................................................................................1
APPENDIX A ...............................................................................................................................1
CLINICAL INFORMATION ..................................................................................................................... 1
How does biphasic waveform defibrillate?........................................................................................... 1
Ease in compensation of patient impedance........................................................................................2
More efficient than monophasic waveform .........................................................................................3
Enough Energy for restoring heart rhythm...........................................................................................5
REFERENCES .......................................................................................................................................9
APPENDIX B ...............................................................................................................................1
TECHNICAL SPECIFICATIONS ................................................................................................................1
IMPENDANCE LIMITS ..........................................................................................................................2
SYNC/NO SYNC MODE.........................................................................................................................2
CHARGING TIME TO ACHIEVE THE MAXIMUM ENERGY (230 JOULE) .....................................................2
APPENDIX C ...............................................................................................................................1
TECHNICAL FEATURES ......................................................................................................................... 1
APPENDIX D –INSTRUCTION FOR USE FOR DISPOSABLE MULTIFUNCTION ELECTRODES FOR
DEFIBRILLATOR...........................................................................................................................1
CAUTION ............................................................................................................................................ 1

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IMPORTANT........................................................................................................................................1
DESCRIPTION......................................................................................................................................1
PACKAGING ........................................................................................................................................1
INDICATIONS ...................................................................................................................................... 1
CONTRAINDICATIONS .........................................................................................................................1
MODE OF USE.....................................................................................................................................1
MODE OF APPLICATION ...................................................................................................................... 2
POSITIONING AND POLARITY ..............................................................................................................3
SIDE EFFECTS ......................................................................................................................................3
PRECAUTIONS AND WARNINGS...........................................................................................................3
POTENTIAL COMPLICATIONS ...............................................................................................................4
PRODUCT LIFE AND STORAGE.............................................................................................................. 4
DISPOSAL ...........................................................................................................................................5
WARRANTY AND LIMITATIONS ............................................................................................................5
APPENDIX E - DECLARATION OF EU CONFORMITY .......................................................................1
WARRANTY CERTIFICATE..................................................................................................................... 2

Rescue Life 9–Instruction For Use Rev.0.5 –30/03/2022
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Disclaimer of Liability
PROGETTI S.r.l., as Manufacturer of the medical device Rescue Life9and of its accessories, is
responsible of the safety and performances within expected lifetime (10 years). If the customer
cannot demonstrate compliance to the use, maintenance and storage provisions of the present
user manual, PROGETTI S.r.l. will be not responsible of Rescue Life9 ’s safety and performances.
PROGETTI S.r.l. disclaims any responsibility for any accidental damage caused to the Rescue Life9
and its accessories during transport to the customer or during use.
PROGETTI S.r.l. is available to the customer for any further information.
The information contained in this document may be subject to change without notice.
Limited Warranty
The "Limited Warranty" shipped with PROGETTI products is the one and only with regard to the
product.
Useful contacts
•COMPANY - [e-mail]
•SALES –[e-mail]
•SERVICE - [e-mail]
•QUALITY & REGULATORY AFFAIRS - [e-mail]
For the purpose of continuous improvement, the Manufacturer is pleased to welcome and
manage the customer's opinion on the device and / or on this user manual. Therefore write to
the Quality & Regulatory department of PROGETTI S.r.l. ([email protected]) for any
suggestions or explanations.
Please report any serious accident occurring in relation to the medical device by sending an
email to the addresses [email protected]m and [email protected]
PROGETTI S.r.l. recommends to subject the Rescue Life9to an annual preventive
maintenance program (functional check and electrical safety check) and to check during the
service period of the medical device:
• the integrity of the main unit casing and its accessories;
• the integrity of the packaging of the multifunction disposable electrodes and their
cable as well as the validity of the same (see expiry date on the labeling);
• the legibility of the labeling.
For more information, please contact the PROGETTI technical assistance service at the email
address [email protected] or at the telephone number +39.011.644.738

1 INTRODUCTION

Rescue Life 9–Instruction For Use Rev.0.5 –30/03/2022
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1.1 INTENDED USE (PATIENTS GROUP AND MEDICAL CONDITIONS)
The RESCUE LIFE 9 is a NON-INVASIVE ACTIVE MEDICAL DEVICE intended for treatment of cardiac
arrhythmias such as a) Ventricular Fibrillation (VF), b) Fast Ventricular Tachycardia (FVT). In this field is
possible the acquisition of biomedical parameters like ECG.
The RESCUE LIFE 9 can be applied to the following classes of patients:
•Adult patients (including pregnant women, as no significant clinical data is available in the literature
to demonstrate unacceptable adversities, relating to the intended use, on the patient and her
fetus);
•Pediatric patients (age <8 years or weight <25 kg).
Neonatal patients (<1 year of age) are not intended for treatment.
The manufacturer recommends to not use RESCUE LIFE 9in the following environments:
•Places where high oxygen concentration is present;
•Places where inflammable substances are present.
In manual mode the RESCUE LIFE 9 is intended to be used by health care professionals and emergency
rescue personnel who have been trained in Advanced Life Support (ALS) protocol. The user must know how
to interpret ECG's, decide the energy level required and when the defibrillation is necessary.
RESCUE LIFE 9 is designed for any group of patients to treat:
-Ventricular Fibrillation (VF)
-Fine Ventricular Fibrillation (FVF)
-Ventricular Tachycardia (VT) with a rate higher than 150 bpm (beats per minute)
Used in MANUAL MODE, RESCUE LIFE 9 is designed to be used on pediatric patients
1
, adult patients
and on "special patients" (e.g. pregnancy women) according to the ECR Guidelines 2015 - Section 4
"Cardiac arrest in special circumstances" par. C - SPECIAL PATIENTS.
Moreover it is designed to treat, by means of Synchronous defibrillation (cardioversion), patients with
ECG's that show the presence of Atrial Fibrillation. It is designed to monitor patient ECG by means of the
multiple signal acquisition electrodes.
The pacing option is indicated for treating patients with symptomatic bradycardia.
Used in AUTOMATED MODE (AED), RESCUE LIFE 9 is designed to be used on adult patients (by use of
DISPOSABLE MULTINFUNCTIONAL ELECTRODES –ADULT PATIENTS), on pediatric patients (by use of
DISPOSABLE MULTINFUNCTIONAL ELECTRODES –PEDIATRIC PATIENTS) and special patients (e.g. pregnant
women) according to the ECR Guidelines 2015 - Section 4 "Cardiac arrest in special circumstances" par. C -
SPECIAL PATIENTS.
1
Pediatric patient: a person of age under 8 years and weighing less than 25 Kg.

Rescue Life 9–Instruction For Use Rev.0.5 –30/03/2022
1 - INTRODUCTION
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When used in AED mode, the RESCUE LIFE 9 is a semiautomatic defibrillator that provides a prompted
treatment protocol and ECG analysis using special analysis algorithm. This software algorithm analyzes the
patient’s electrocardiographic (ECG) rhythm and indicates whether or not a shockable rhythm is detected.
AED mode requires operator interaction in order to defibrillate the patient.
AED MODE ON RESCUE LIFE 9IS RECOMMENDED FOR USE BY PERSONNEL WHO ARE AUTHORIZED BY A PHYSICIAN OR MEDICAL
DIRECTOR AND HAVE,AT A MINIMUM,THE FOLLOWING SKILLS AND TRAINING:
•CPR TRAINING
•AED TRAINING EQUIVALENT TO THAT RECOMMENDED BY THE AMERICAN HEART ASSOCIATION (AHA)OR THE EUROPEAN
RESUSCITATION COUNCIL (ERC)