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InoHeal Product Specification - Device and Kit

The document describes a negative pressure wound therapy device called InoHeal. It has been designed and manufactured in India to provide precise NPWT. The device offers controlled negative pressure ranging from -40 to -200 mm Hg in 5 mm Hg increments and includes features like monitoring pressure and time, alarms, and certifications.

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chaitanya
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0% found this document useful (0 votes)
219 views8 pages

InoHeal Product Specification - Device and Kit

The document describes a negative pressure wound therapy device called InoHeal. It has been designed and manufactured in India to provide precise NPWT. The device offers controlled negative pressure ranging from -40 to -200 mm Hg in 5 mm Hg increments and includes features like monitoring pressure and time, alarms, and certifications.

Uploaded by

chaitanya
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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‭InoHeal‬‭TM‬

‭(Precisely regulated negative‬‭pressure wound therapy)‬

‭Device‬ ‭Dressing kit‬

‭Designed, developed and manufactured in India by‬


‭Inochi Care Private Limited‬
[email protected]
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‭Technical Features of InoHeal‬‭TM‬‭Device‬


‭For Precisely Regulated Negative Pressure Wound Therapy‬

‭The‬ ‭InoHeal‬ ‭device‬ ‭has‬ ‭been‬ ‭designed‬ ‭&‬ ‭developed‬ ‭to‬ ‭provide‬ ‭precise‬ ‭negative‬

‭pressure‬ ‭wound‬ ‭therapy‬ ‭for‬ ‭chronic,‬ ‭trauma,‬ ‭and‬ ‭post-surgical‬ ‭wounds.‬ ‭The‬ ‭InoHeal‬

‭device has the following functional features:‬

‭↳‬ ‭The machine is made of fire-resistant material for safety and a better lifespan‬

‭↳‬ ‭Offers precisely controlled NPWT in the‬‭range of -40‬‭to -200 mm Hg with steps of‬

‭5mmHg for effectively managing the wound of various etiologies‬

‭↳‬ ‭Therapy modes: NPWT (continuous) and NPWT (Intermittent)‬

‭↳‬ ‭One-click pressure and parameter settings‬

‭↳‬ ‭Real-time‬ ‭monitoring‬ ‭of‬ ‭set‬ ‭pressure/‬ ‭running‬ ‭pressure‬ ‭along‬ ‭with‬ ‭run‬ ‭time‬‭on‬

‭one screen for easy understanding of therapy information.‬

‭↳‬ ‭Canister‬ ‭with‬ ‭600‬ ‭ml‬ ‭storage‬ ‭capacity,‬ ‭integrated‬ ‭bacterial‬ ‭filter,‬ ‭and‬ ‭waste‬

‭solidifier‬

‭↳‬ ‭Multi-lumen tubings for both the trackpad and the canister for efficient pressure‬

‭control‬

‭↳‬ ‭Kink-resistant trackpad tubing & canister tubings to prevent accidental blockage‬

‭of the therapy‬

‭↳‬ ‭Colored graphical user interface screen with a screen lock facility‬

‭↳‬ ‭A portable, lightweight device (weight <2.0 kg) makes it easy to carry the device‬

‭(easy to be carried by the elderly & females)‬

‭↳‬ ‭Pushbuttons interphase with Colored, Backlight display for easier visibility and‬

‭screen lock facility‬

‭© 2023 Inochi Care Private Limited‬


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‭↳‬ ‭Electronically/Battery operated with 6-8 hrs of battery backup‬‭for enhanced‬

‭patient freedom‬

‭↳‬ ‭Highly sophisticated alarms for pressure leakage, pressure block, canister full,‬

‭low battery, and device error.‬

‭↳‬ ‭The night-mode facility dims the screen intensity during nighttime to minimize‬

‭patient disturbance‬

‭↳‬ ‭The device has a charging indicator so the user knows when the device is‬

‭connected to the charger.‬

‭↳‬ ‭The device is IEC 60601-1 certified for EMI/EMC safety by an NABL-approved‬

‭lab.‬

‭↳‬ ‭The device is manufactured at an NABCB-approved ISO 13485:2016 certified‬

‭facility.‬

‭↳‬ ‭The device is approved for pressure accuracy at an NABL-approved lab and‬

‭maintains the target negative pressure with a precision of +-1% at the wound‬

‭site.‬

‭↳‬ ‭The device is approved by CDSCO under Class C manufacturing.‬

‭Quality Certifications standards‬

‭InoHeal‬ ‭has‬ ‭been‬ ‭designed‬ ‭&‬ ‭developed‬ ‭as‬ ‭per‬ ‭the‬ ‭best‬ ‭industry‬ ‭standards‬ ‭and‬

‭practices.‬ ‭The‬ ‭manufacturing‬ ‭site‬ ‭has‬ ‭received‬ ‭a‬ ‭manufacturing‬ ‭license‬ ‭from‬ ‭the‬

‭CDSCO, India (Class C).‬

‭Certificate‬ ‭Compliance‬ ‭Advantages‬

‭ISO 13485:2016 by‬ ‭Quality‬ ‭1.‬ ‭Consistent product quality and product performance‬
‭NABCB and‬ ‭Management‬ ‭2.‬ ‭Assured Product safety and conformity‬
‭CDSCO-approved‬ ‭System‬ ‭3.‬ ‭Fulfills the regulatory requirement of the CDSCO,‬
‭certification body‬ ‭India‬

‭© 2023 Inochi Care Private Limited‬


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‭ISO 60601-1 compliance‬ ‭Electrical safety‬ ‭1.‬ ‭No risk of electric shock‬
‭testing‬ ‭(EMI/EMC) as per‬ ‭2.‬ ‭Electromagnetic interference avoided‬
‭global standards‬ ‭3.‬ ‭Compliance with established regulatory‬
‭requirements‬

‭Pressure accuracy by‬ ‭Precisely‬ ‭Maintaining precise negative pressure is essential for‬
‭NABL-approved‬ ‭Controlled‬ ‭optimum wound healing, because:‬
‭certification body‬ ‭negative pressure‬ ‭1.‬ ‭Actual pressure < set pressure → skin maceration‬
‭delivery‬ ‭2.‬ ‭Actual pressure > set pressure → skin rupture and‬
‭bleeding risk‬

‭For further information contact at‬


‭Inochi Care Private Limited‬

‭Email: [email protected] Phone: 011-40415913‬

‭© 2023 Inochi Care Private Limited‬


‭InoHeal‬‭TM‬
‭Product Specifications‬‭of InoHeal NPWT Kit‬

‭Device‬ ‭Dressing kit‬


‭2‬

‭Product Specifications of InoHeal‬‭NPWT‬‭Kit‬


‭Accessories-Dressing kit & Canister‬

‭The dressing foam is available in three sizes:‬

‭⇰‬ ‭Small……………………………………….……………………………………………………7.5 X 10 X 3 cm‬


‭⇰‬ ‭Medium ………………………………………….………………………………………….12.5 X 18 X 3 cm‬
‭⇰‬ ‭Large……………………………………………….…………………………………………..18 X 25 X 3 cm‬
‭⇰‬ ‭Nature……..……………………………………..……………………………………………Biocompatible‬
‭⇰‬ ‭Type of Material…………………………….……………………………………….Polyurethane‬
‭⇰‬ ‭Pore Size……………………………………..………………………………………………400-600 microns‬
‭⇰‬ ‭Foam Color…………………………………………………………………………………Black‬

‭Canister‬
‭⇰‬ ‭Volume…………………………………………………………………………………………600 ml‬
‭⇰‬ ‭Disposable Unit………….……………………………………………………………Single-Use‬
‭⇰‬ ‭Material………….……………………………………………………………………………Polycarbonate‬
‭⇰‬ ‭Canister tubing length…………………………………………………………100cm‬

‭Super Absorbent polymer for exudate solidification‬

‭© 2023 Inochi Care Private Limited‬


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‭Adhesive drape‬

‭The drape is available in biocompatible and is 30 X 30 cm in size:‬

‭⇰‬ ‭Size…….…………………………….…………………………………………………………….30 X 30 cm‬


‭⇰‬ ‭Type of material……………………………..……………………………………….Polyurethane‬

‭© 2023 Inochi Care Private Limited‬


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‭⇰‬ ‭Nature……..……………………………………………………………………………………Biocompatible‬

‭Connecting Accessories‬

‭⇰‬ ‭Capula with tube for NPWT…………………………………………………130 cm‬


‭⇰‬ ‭Adhesive Conduit Circular Pad…………………….……………………10 cm‬

‭For further information contact at‬


‭Inochi Care Private Limited‬

‭Email: [email protected] Phone: 011-40415913‬

‭© 2023 Inochi Care Private Limited‬

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