Sonic Irrigator PCF - cannulated instrument cleaning sonic irrigation Ultrasonic cleaner Washer Disinfector

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Medisafe America
9423 Corporate Lake Dr.
Tampa FL, 33634

 

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Per ANSI/AAMI ST79:2006/A2:2009,  it is suggested to ensure patient safety, a reusable device must be capable of being thoroughly cleaned and sterilized.  The manufacturer’s written instructions for use are the basis for the department’s policies and procedures and must be kept up-to-date.

Always follow the instrument manufacturers recommendation and instruction for use to ensure that the device can be effectively cleaned and sterilized.

 

Sonic Irrigator - PCF

The Medisafe Sonic Irrigator (SI) PCF automated cleaning system is validated for cleaning and thermal disinfection of  daVinci® EndoWrist® instruments.

Medisafe Sonic Irrigator “PCF”- is the most versatile instrument cleaning system available today.   Now available as purchase option, thermal disinfection for complex cannulated instruments both inside and out, in a fully validated and tested process.  (See disinfection model option below)

Cleaning then disinfecting up to 20 standard lumened instruments at temperatures up to 195ºF both inside and out, in approximately 45-minutes per cycle. 

Through our dedicated daVinci cycle, the SI PCF system offers an efficient and convenient way to clean up to 10 EndoWrist instruments simultaneously.    For daVinci customers with EndoWrist instruments the Medisafe SI-PCF systems can perform both qualified cleaning along with disinfection by simply selecting “cycle #6” on systems digital display. For the qualified EndoWrist cleaning cycle without disinfection, select “cycle #3”.

Thermal disinfection for EndoWrist instruments may not be available in all countries.

Other unique feature of the SI-PCF system; automatic fill, auto pre-washing, auto enzyme injection, auto high volume sonic-flushing wash, auto high volume sonic-rinsing, auto drain. .... OR.... to add maximum versatility when needed, simply use the PCF system in a 'sonic only mode' as you would a standard ultrasonic system for walk up convenient use for cleaning basic instruments and trays.


For a complete list of EndoWrist instruments validated with the Medisafe SI PCF system, click here. For a copy of the IFU supplement that ships with validated EndoWrist instruments, click here.

The PCF system has unequalled convenience and versatility !  NEW Dock & Lock basket system, convenient spray arm (optional), oversized basin,  ‘sonic only’ mode for regular instrument cleaning, interlocking cabinet design allows you to combine two PCF systems at anytime for a dual tank, maximum throughput that can grow with your hospitals cleaning demands.
 
Special plumbing/drainage/electrical required and is responsibility of purchaser (call for installation specifications).
208v/3phase electrical required.  
14.7 gal tank size
35.5” length x 26.0” width x 41.0” high (add 19” with lid open).
For optimal cleaning performance always use manufacturer's recommend
     3E-Zyme Triple Enzyme Cleaning Solution  (#MEDIS-12042)

Specifications

Sonic Irrigator – PCF models:

#MED11121STD {Std instrument system, includes standard 20 lumened instrument connection basket

#MED11121S
{daVinci system, includes daVinci® EndoWrist® 10 instrument connection basket

#MED11121D {daVinci system w/ disinfection capability,  includes daVinci® EndoWrist® 10 instrument connection basket


Quality


Manufactured in the UK under Medisafe’s IS09001 Quality and UL approved.

Use


For internal and external cleaning of cannulated / lumened surgical instrumentation

Environmental


For indoor use at altitudes up to 2000m / 6000ft
Operating temperature -5°C / 23°F   to   91°C / 195°F
Humidity -80% RH max for temperatures up to 31°C / 88°F,
decreasing linearly to 50% RH at 40°C / 104°F
Designed for Pollution Degree 2, i.e. not totally sealed.

General Description                      


Medical Device Class II  - for low or intermediate level disinfection

Operating Process


Ultrasonic activity plus high volume flushing

Applied Standards


BS2745: part 1: 1993
BS2745: part 3: 1993
EN60101-1:2001 (2nd Edition)
EN61010-2-045 (2001)
EN61326: 1997
A1: 1998
EN980                        

Wash Cycle Parameters


Min. Temp. During Cycle: determined by temperature of water supply
Max. Temp. During Cycle: 91° C / 195° F
Vol. of Dispensed Chemicals
Wash chemical: Detergent 414ml / 14.0oz (approx)
Final rinse chemical: 414ml / 14.0oz (approx)

Electricity Supply


208V  / 3phase / 60Hz
24 AMPS per phase max
15K watts
Lead Length: 5 feet

Printer:
Supply Voltage: single phase 110v / 0.1 amps (nominal) AC

Required Utilities


Water Supply

Cold water supply terminating into a Male ¾” NPT National Pipe Thread hose fitting

Hot water supply terminating into a Male ¾” NPT National Pipe Thread  hose fitting.  

Acceptable Pressure Range:
2.0 – 5.0 BAR (29 –72 PSI) hot & cold

Acceptable Incoming Water Temperature Range:
Hot:  104°F   - 140°F
Cold   41°F –  95°F   
Hardness CaCo3:    less than 110 ppm (HTM2030)

Drain


Type:    Single 4” diameter floor drain fitted with suitable traps on building side within 20” of equipment

>OR<  

Wall drain not more than 14” from floor is acceptable (no more than 48” from equipment)  Wall drain must accept 2.5” collar in diameter and be greater than 8 gallons per min.
 
Max. Flow to Drain:  8 gallons per min
Max. Temp. of Effluent: 91° C / 195° F.

Ventilation


Max. Heat Output of Load: 91° C / 195° F

Weight & Dimensions


Operational weight
267.5kgs / 587.7lbs
Wash Chamber Volume: 14.75 gal

Outer Cabinet Dimensions:
33.9”  (w)
22.8” (front to back) add approx 6” for plumbing outlet
43.7” (h) add approx 15” when lid fully opened

 

 
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