PR16118128 - SOW AED Defibrillator Lifepak CR2 4G.pdf

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Purchase of Lifepak CR2 4G (SIM) Defibrillators
Solicitation number
PR16118128
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This is a Statement of Work for procurement reference PR16118128 addressing the replacement of obsolete Automated External Defibrillators (AEDs) with new LIFEPAK CR2 4G Semi-automatic defibrillators.

The primary deliverable is the LIFEPAK CR 2 semi-automatic defibrillator with handle, dual language capability (English/German), and mobile data connectivity. Key technical specifications include cprINSIGHT ECG analysis technology, push-button pediatric mode without additional electrodes, LIFELINKcentral remote device monitoring and software updates, ClearVoice automatic volume adjustment, cprCOACH continuous CPR feedback technology, and an 8-year warranty. The procurement also requires a lifelong data plan for the LIFEPAK CR2 that includes cellular charges for data transmission to LIFELINKcentral and LIFENET systems.

Additional required services include online AED instruction and device commissioning conducted by a certified instructor via Teams (approximately 30 minutes duration), covering AED instruction per applicable medical device regulations, device commissioning, and CPR manikin case study simulation. Instruction sessions are available Monday through Thursday 08:00-17:00 or Friday 08:00-15:00, with cancellations permitted free of charge up to 7 days prior to the scheduled appointment. The procurement further includes a First Aid Emergency Kit containing washcloth, scissors, resuscitation mask, razor, nitrile gloves, and hair tie; preparation of a medical device logbook per applicable ordinance requirements; and return of old defibrillator devices as part of a generational equipment transition.

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PR16118128 - Defibrillator Lifepak CR2 4G

Statement of work Summary: Current AEDs are no longer supported by the manufacturer. Supplies are also not being manufactured anymore. Machine therefore no longer usable.

Specifications: LIFEPAK CR 2 Halbautomat mit Handgriff, 2 Sprachen, mobile Datenübertragung (Lifepak CR2 Semi-automatic with handle, dual-language (EN/ GER), mobile data connection

• halbautomatischer Defibrillator mit Handgriff

• cprINSIGHT EKG-Analysetechnologie

• Kindermodus auf Tastendruck ohne zusätzliche Kinderelektroden

• LIFELINKcentral (mobile Datenübertragung) für Geräte-Fernüberwachung und Software Updates - z.B. bei Verbesserungen der Wiederbelebungsrichtlinien

• ClearVoice - Technologie passt die Lautstärke der Sprachansagen automatisch an

• cprCOACH Feedback-Technologie für eine höhere HLW-Qualität (kontinuierliche HLW)

• 8 Jahre Garantie

(ENGLISH:

semi-automatic defibrillator with handle

• cprINSIGHT ECG analysis technology

• Push-button child mode—no need for special pediatric electrodes

• LIFELINKcentral (mobile data transmission) for remote device monitoring and software updates—e.g., for updates to resuscitation guidelines

• ClearVoice technology automatically adjusts voice prompt volume

• cprCOACH feedback technology for improved CPR quality (continuous

CPR)

• 8-year warranty)

Datenplan für LIFEPAK CR 2 mit mobiler Datenübertragung, lebenslange Laufzeit (Data plan for Lifepak CR2 with mobile data transmission, life-long service)

• Enthält die Mobilfunkgebühren für die Übertragung von Daten des

LIFEPAK CR2 an LIFELINKcentral und LIFENET

(ENGLISH:

• Includes cellular charges for transmitting data from the LIFEPAK CR2 to LIFELINKcentral and LIFENET.)

Additional required functions:

Online AED-Einweisung inkl. Inbetriebnahme nach §11 MPBetreibV Durchgeführt von einem zertifizierten Dozenten über Teams. Dauer

ca. 30 Minuten.

Inklusive:

• AED-Einweisung nach §11, Abs. 1, Satz 1, Nr. 2 MPBetreibV

• Inbetriebnahme von Medizinprodukten der Anlage 1 der MPBetreibV

• Fallbeispielsimulation an einer Reanimationspuppe

Die Einweisung findet von montags bis donnerstags zwischen 08:00 und 17:00 Uhr statt oder freitags zwischen 08.00 Uhr und 15.00 Uhr.

Für Terminwünsche außerhalb der regulären Geschäftszeiten können Mehrkosten entstehen.

Soll eine Inbetriebnahme erfolgen, müssen die erworbenen Defibrillatoren zu dem Einweisungstermin verfügbar sein.

Stornierungen oder Änderungen können bis zu 7 Tage vor dem Termin kostenfrei vorgenommen werden.

Danach behalten wir uns vor, bis zu 100% der Kosten in Rechnung zu stellen.

Die Einweisung wird i.d.R. von einem externen Partner durchgeführt.

Hierfür werden Ihre Kontaktdaten an den Schulungspartner übermittelt.

(ENGLISH:

Online AED instruction, including commissioning in accordance with §11 MPBetreibV Conducted by a certified instructor via Teams. Duration: approx. 30 minutes.

Includes:

• AED instruction pursuant to §11, Para. 1, Sentence 1, No. 2 MPBetreibV

• Commissioning of medical devices listed in Annex 1 of the MPBetreibV

• Case study simulation using a CPR manikin

Instruction sessions take place Monday through Thursday between 08:00 and 17:00, or Friday between 08:00 and 15:00.

Additional costs may apply for appointments requested outside regular business hours.

If commissioning is to be performed, the purchased defibrillators must be available at the time of the instruction session.

Cancellations or changes may be made free of charge up to 7 days prior to the appointment.

After this time, we reserve the right to charge up to 100% of the costs.

Instruction is generally conducted by an external partner.

For this purpose, your contact details will be shared with the training partner.)

Erste-Hilfe Notfall-Set Inhalt:

1 x großer Einmal-Trockenwaschlappen 1 x Kleiderschere mit festem schwarzen Griff 1 x Beatmungsmaske 1 x Einwegrasierer 1 x Paar Einweg-Nitril-Handschuhe 1 x Haargummi

(Translation:

First Aid Emergency Kit Contents:

1 x Large disposable dry washcloth 1 x Dressing scissors with sturdy black handles 1 x Resuscitation mask 1 x Disposable razor 1 x pair of disposable nitrile gloves 1 x Hair tie)

Erstellung Medizinproduktebuch Fachgerechtes Anlegen und Ausfüllen des Medizinproduktebuchs nach §7 Medizinproduktebetreiberverordnung (ENGLISH: Preparation of the medical device logbook

Proper setup and maintenance of the medical device logbook in accordance with Section 7 of the Medical Device Operator Ordinance)

Statement of work

Defibrillator “Generationswechsel” (ENGLISH: Defibrillator return of old devices)

Summary:
Specifications:
Additional required functions:
Statement of work

File details come from the government source that posted it. Updated .