Application Specification - Revision history

Rkonstanz at 16:13, 8 September 2017

2017-09-08T16:13:54Z

← Older revision		Revision as of 16:13, 8 September 2017
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	<br />		<br />
	~~<div style="text-align: right; margin:5px;">'''<small>GC-01-OUM-0043 Rev D</small><br /></div>~~

Rkonstanz at 15:31, 27 July 2017

2017-07-27T15:31:31Z

← Older revision		Revision as of 15:31, 27 July 2017
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	===Manufacturer===		===Manufacturer===
	GrandCare Systems, LLC<br />		GrandCare Systems, LLC<br />
	215. Main St., Suite 160<br />		215 N. Main St., Suite 160<br />
	West Bend, WI 53095<br />		West Bend, WI 53095<br />
	USA<br />		USA<br />

Rkonstanz: /* Manufacturer */

2017-07-24T21:41:39Z

Manufacturer

← Older revision		Revision as of 21:41, 24 July 2017
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	===Manufacturer===		===Manufacturer===
	GrandCare Systems, LLC<br />		GrandCare Systems, LLC<br />
	~~327 N~~. Main St.<br />		215. Main St., Suite 160<br />
	West Bend, WI 53095<br />		West Bend, WI 53095<br />
	USA<br />		USA<br />
	~~phone~~: 1-262-338-6147<br />		Phone: 1-262-338-6147<br />
	~~fax: 1-262-353-9401<br /><br />~~


	<br />		<br />
	<div style="text-align: right; margin:5px;">'''<small>GC-01-OUM-0043 Rev C</small><br /></div>		<div style="text-align: right; margin:5px;">'''<small>GC-01-OUM-0043 Rev D</small><br /></div>

Eumhoefer at 21:16, 14 July 2017

2017-07-14T21:16:24Z

← Older revision		Revision as of 21:16, 14 July 2017
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	__NOTOC__ ~~<h3 style~~=~~"display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;"><br />~~Intended Use~~</h3>~~		__NOTOC__
			===Intended Use===
	The My GrandCare Monitoring System Product Family is a communication tool that allows caregivers to remotely access vital sign measurements of adult patients in their residences. It is a software application running on a Commercial Off The Shelf (COTS) Personal Computer (PC). It collects measurements captured on commercially available wireless medical devices which are designed for home use and connection to a COTS PC. It displays the collected measurement on the PC, and securely stores the collected information locally on a memory device installed in the PC for the patient to view, and for the caregiver to view remotely via a host server. The My GrandCare Monitoring System Family can be used to display educational and motivational content from the caregiver and can facilitate communication between the caregiver and patient via health wellness surveys and optional video conferencing.		The My GrandCare Monitoring System Product Family is a communication tool that allows caregivers to remotely access vital sign measurements of adult patients in their residences. It is a software application running on a Commercial Off The Shelf (COTS) Personal Computer (PC). It collects measurements captured on commercially available wireless medical devices which are designed for home use and connection to a COTS PC. It displays the collected measurement on the PC, and securely stores the collected information locally on a memory device installed in the PC for the patient to view, and for the caregiver to view remotely via a host server. The My GrandCare Monitoring System Family can be used to display educational and motivational content from the caregiver and can facilitate communication between the caregiver and patient via health wellness surveys and optional video conferencing.

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	The system can also be used for social interaction between caregivers and patients, and to collect non-medical information from commercially available activity of daily living sensors, such as motion, door, bed and temperature sensors, caller ID modems, and action buttons, which can be reviewed by caregivers, and which can trigger rule-based notifications to caregivers.<br /><br />		The system can also be used for social interaction between caregivers and patients, and to collect non-medical information from commercially available activity of daily living sensors, such as motion, door, bed and temperature sensors, caller ID modems, and action buttons, which can be reviewed by caregivers, and which can trigger rule-based notifications to caregivers.<br /><br />

	~~<h3 style~~=~~"display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">~~Indications for Use~~</h3>~~		===Indications for Use===
	The My GrandCare Monitoring System Product Family is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the, caregivers' questions by participating in surveys.		The My GrandCare Monitoring System Product Family is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the, caregivers' questions by participating in surveys.

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	The My GrandCare Monitoring System Product Family is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.<br /><br />		The My GrandCare Monitoring System Product Family is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.<br /><br />

	~~<h3 style~~=~~"display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">~~How Used~~</h3>~~		===How Used===
	The system collects measurements captured on commercially available personal computers, from commercially available wireless medical devices which are designed for home and assisted living center use, and displays the information on the computer screen for the patient, and through an Internet interface for the caregiver. The system can provide alerts to caregivers when health readings have been taken or not taken, or medication has been accessed or not accessed. It can provide prompts to patients when it is time to taken medications, and information about the medication.<br /><br />		The system collects measurements captured on commercially available personal computers, from commercially available wireless medical devices which are designed for home and assisted living center use, and displays the information on the computer screen for the patient, and through an Internet interface for the caregiver. The system can provide alerts to caregivers when health readings have been taken or not taken, or medication has been accessed or not accessed. It can provide prompts to patients when it is time to taken medications, and information about the medication.<br /><br />

	~~<h3 style~~=~~"display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">~~Intended Users~~</h3>~~		===Intended Users===
	End users are adult home-based patients or adult assisted living-based patients with long-term monitoring needs and their caregivers.<br /><br />		End users are adult home-based patients or adult assisted living-based patients with long-term monitoring needs and their caregivers.<br /><br />

	~~<h3 style~~=~~"display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">~~Intended Use Environment(s)~~</h3>~~		===Intended Use Environment(s)===
	Patient residences, private homes or assisted living centers.<br /><br />		Patient residences, private homes or assisted living centers.<br /><br />

	~~<h3 style~~=~~"display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">~~Targeted Patient Populations~~</h3>~~		===Targeted Patient Populations===
	Home-based adult patients with chronic conditions that require long-term, retrospective monitoring.<br /><br />		Home-based adult patients with chronic conditions that require long-term, retrospective monitoring.<br /><br />

	~~<h3 style~~=~~"display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">~~Contraindications~~</h3>~~		===Contraindications===
	See Indication for Use.<br /><br />		See Indication for Use.<br /><br />

	~~<!--~~
	~~<h3 style~~=~~"display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">~~Common Name~~</h3>~~		===Common Name===
	Transmitters and Receivers, Physiological Signal, Radiofrequency Devices<br /><br />		Transmitters and Receivers, Physiological Signal, Radiofrequency Devices<br /><br />

	~~<h3 style~~=~~"display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">~~Manufacturer~~</h3>~~		===Manufacturer===
	GrandCare Systems, LLC<br />		GrandCare Systems, LLC<br />
	327 N. Main St.<br />		327 N. Main St.<br />
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	phone: 1-262-338-6147<br />		phone: 1-262-338-6147<br />
	fax: 1-262-353-9401<br /><br />		fax: 1-262-353-9401<br /><br />
	~~-->~~

	<br />		<br />
	<div style="text-align: right; margin:5px;">'''<small>GC-01-OUM-0043 Rev C</small><br />~~[[Media:ApplicationSpecification.pdf\|<i class="fa fa-file-pdf-o"></i> PDF Format]]'''~~</div>		<div style="text-align: right; margin:5px;">'''<small>GC-01-OUM-0043 Rev C</small><br /></div>

Kristin: Formatting changes

2016-01-25T15:24:34Z

Formatting changes

← Older revision		Revision as of 15:24, 25 January 2016
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	fax: 1-262-353-9401<br /><br />		fax: 1-262-353-9401<br /><br />
	-->		-->
	<div style="text-align: right;"><small>GC-01-OUM-0043 Rev C</small></~~div>~~
	~~<small~~>[[Media:ApplicationSpecification.pdf\|~~PDF format]]~~<~~/small~~><br /><br />		<br />
			<div style="text-align: right; margin:5px;">'''<small>GC-01-OUM-0043 Rev C</small><br />[[Media:ApplicationSpecification.pdf\|<i class="fa fa-file-pdf-o"></i> PDF Format]]'''</div>

Ashley at 22:08, 3 March 2014

2014-03-03T22:08:55Z

Kristin: Reverted back to previous version until after 510(k) clearance

2013-09-26T18:03:27Z

Reverted back to previous version until after 510(k) clearance

← Older revision		Revision as of 18:03, 26 September 2013
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	See Indication for Use.<br /><br />		See Indication for Use.<br /><br />

			<!--
	<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Common Name</h3>		<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Common Name</h3>
	Transmitters and Receivers, Physiological Signal, Radiofrequency Devices<br /><br />		Transmitters and Receivers, Physiological Signal, Radiofrequency Devices<br /><br />
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	phone: 1-262-338-6147<br />		phone: 1-262-338-6147<br />
	fax: 1-262-353-9401<br /><br />		fax: 1-262-353-9401<br /><br />
			-->
	<div style="text-align: right;"><small>GC-01-OUM-0043 Rev C</small></div>		<div style="text-align: right;"><small>GC-01-OUM-0043 Rev B</small></div>
	<small>[[Media:ApplicationSpecification.pdf\|PDF format]]</small><br /><br />		<small>[[Media:ApplicationSpecification.pdf\|PDF format]]</small><br /><br />

Kristin at 18:00, 26 September 2013

2013-09-26T18:00:24Z

← Older revision		Revision as of 18:00, 26 September 2013
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	<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Manufacturer</h3>		<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Manufacturer</h3>
	GrandCare Systems, LLC<br />		GrandCare Systems, LLC<br />
	327 N. Main St.		327 N. Main St.<br />
	West Bend, WI 53095		West Bend, WI 53095<br />
	USA		USA<br />
	phone: 1-262-338-6147		phone: 1-262-338-6147<br />
	fax: 1-262-353-9401		fax: 1-262-353-9401<br /><br />
	<br /><br />

	<div style="text-align: right;"><small>GC-01-OUM-0043 Rev C</small></div>		<div style="text-align: right;"><small>GC-01-OUM-0043 Rev C</small></div>
	<small>[[Media:ApplicationSpecification.pdf\|PDF format]]</small><br /><br />		<small>[[Media:ApplicationSpecification.pdf\|PDF format]]</small><br /><br />

Kristin: Added Manufacturer Info

2013-09-26T17:59:58Z

Added Manufacturer Info

← Older revision		Revision as of 17:59, 26 September 2013
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	<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Common Name</h3>		<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Common Name</h3>
	Transmitters and Receivers, Physiological Signal, Radiofrequency Devices<br /><br />		Transmitters and Receivers, Physiological Signal, Radiofrequency Devices<br /><br />

			<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Manufacturer</h3>
			GrandCare Systems, LLC<br />
			327 N. Main St.
			West Bend, WI 53095
			USA
			phone: 1-262-338-6147
			fax: 1-262-353-9401
			<br /><br />

	<div style="text-align: right;"><small>GC-01-OUM-0043 Rev C</small></div>		<div style="text-align: right;"><small>GC-01-OUM-0043 Rev C</small></div>
	<small>[[Media:ApplicationSpecification.pdf\|PDF format]]</small><br /><br />		<small>[[Media:ApplicationSpecification.pdf\|PDF format]]</small><br /><br />

Kristin: Added FDA Common Name

2013-09-26T17:56:18Z

Added FDA Common Name

← Older revision		Revision as of 17:56, 26 September 2013
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	See Indication for Use.<br /><br />		See Indication for Use.<br /><br />

	<div style="text-align: right;"><small>GC-01-OUM-0043 Rev B</small></div>		<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Common Name</h3>
			Transmitters and Receivers, Physiological Signal, Radiofrequency Devices<br /><br />

			<div style="text-align: right;"><small>GC-01-OUM-0043 Rev C</small></div>
	<small>[[Media:ApplicationSpecification.pdf\|PDF format]]</small><br /><br />		<small>[[Media:ApplicationSpecification.pdf\|PDF format]]</small><br /><br />

← Older revision		Revision as of 22:08, 3 March 2014
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	__NOTOC__ <h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;"><br />Intended Use</h3>		__NOTOC__ <h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;"><br />Intended Use</h3>
	The My GrandCare Monitoring System Product Family is a communication tool that allows caregivers to remotely access vital sign measurements of patients ~~at home~~. It is a software application running on a Commercial Off The Shelf (COTS) Personal Computer (PC). It collects measurements captured on commercially available wireless medical devices which are designed for home use and connection to a COTS PC. It displays the collected measurement on the PC, and securely stores the collected information locally on a memory device installed in the PC for the patient to view, and for the caregiver to view remotely via a host server. The My GrandCare Monitoring System Family can be used to display educational and motivational content from the caregiver and can facilitate communication between the caregiver and patient via health wellness surveys and optional video conferencing.		The My GrandCare Monitoring System Product Family is a communication tool that allows caregivers to remotely access vital sign measurements of adult patients in their residences. It is a software application running on a Commercial Off The Shelf (COTS) Personal Computer (PC). It collects measurements captured on commercially available wireless medical devices which are designed for home use and connection to a COTS PC. It displays the collected measurement on the PC, and securely stores the collected information locally on a memory device installed in the PC for the patient to view, and for the caregiver to view remotely via a host server. The My GrandCare Monitoring System Family can be used to display educational and motivational content from the caregiver and can facilitate communication between the caregiver and patient via health wellness surveys and optional video conferencing.

	The My GrandCare Monitoring System Product Family is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.		The My GrandCare Monitoring System Product Family is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
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	<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Intended Users</h3>		<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Intended Users</h3>
	End users are home-based patients or assisted living-based patients with long-term monitoring needs and their caregivers.<br /><br />		End users are adult home-based patients or adult assisted living-based patients with long-term monitoring needs and their caregivers.<br /><br />

	<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Intended Use Environment(s)</h3>		<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Intended Use Environment(s)</h3>
	Patient ~~homes~~, private homes or assisted living centers.<br /><br />		Patient residences, private homes or assisted living centers.<br /><br />

	<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Targeted Patient Populations</h3>		<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Targeted Patient Populations</h3>
	Home-based patients with chronic conditions that require long-term, retrospective monitoring.<br /><br />		Home-based adult patients with chronic conditions that require long-term, retrospective monitoring.<br /><br />

	<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Contraindications</h3>		<h3 style="display: inline-block; background:#ffffff; font-weight:bold; border-bottom:2px solid #6093cc; text-align:left; color:#000; padding:0.2em 0.4em;">Contraindications</h3>
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	fax: 1-262-353-9401<br /><br />		fax: 1-262-353-9401<br /><br />
	-->		-->
	<div style="text-align: right;"><small>GC-01-OUM-0043 Rev B</small></div>		<div style="text-align: right;"><small>GC-01-OUM-0043 Rev C</small></div>
	<small>[[Media:ApplicationSpecification.pdf\|PDF format]]</small><br /><br />		<small>[[Media:ApplicationSpecification.pdf\|PDF format]]</small><br /><br />