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The intended use of the iBed™ Wireless with iBed™ Mobile accessory is to assist healthcare professionals in setting, adjusting, and monitoring specific bed parameters from a different location within the healthcare delivery organization's campus. The iBed™ Wireless with iBed™ Mobile accessory is intended to be used only with Stryker Medical's AC-powered adjustable hospital beds that have been verified and validated with the iBed™ Wireless software and is not intended to provide information on non-Stryker Medical beds. The iBed™ Wireless with iBed™ Mobile accessory is intended to only transfer bed status and parameter data and does not store this data.

The Model 5212 iBed™ Wireless with iBed™ Mobile consists of iBed™ Wireless (WiFi module) and the iBed™ Mobile software application that is intended to be used with Stryker Medical's ACpowered adjustable hospital beds within a healthcare delivery organization. The iBed™ Wireless with iBed™ Mobile device accessory is an updated software platform that provides bi-directional data transmission between Stryker Medical's AC-powered adjustable hospital beds equipped with iBed™ Wireless, the healthcare delivery organization's server (owned and maintained by the healthcare delivery organization), and a healthcare professional's handheld electronic device. It is a convenience tool facilitating bi-directional data transmission of bed status data and parameters allowing healthcare professionals the ability to set, adjust, and monitor bed status from a remote location within the healthcare delivery organization facility.

The intended use for the iBed™ Wireless (with iBed™ Awareness) is to assist clinical staff to monitor bed parameters on specific Stryker beds. The desired bed parameters will be set by clinicians at the bedside. The iBed™ Wireless software is intended to be used only with specifically enabled Stryker beds that have been verified and validated with the iBed™ Wireless software, and is not intended to provide bed status information for non-Stryker beds. The iBed™ Wireless software is not intended to communicate any patient status information, nor to permanently store any type of data. The iBed™ Wireless with iBed™ Awareness System is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The iBed™ Wireless with iBed™ Awareness System is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

The iBed™ Awareness is used to monitor hospital bed status and to assist the Healthcare Provider in providing patient care. The system is integrated into Stryker hospital bed to monitor bed information such as: iBed™ Awareness status, bed exit status, siderail status, bed brake status, fowler angle, and weight on bed, for example. The Healthcare Professional can set the alerting function (audible and lights) to activate if bed status has changed. The iBed™ Wireless device is a tool that facilitates the wireless transmission of the bed status data using a wireless hardware and software device to the hospital server. The data can be captured by hospital data collection systems (developed and provided by Third Parties; not part of this submission). Through the use of the third party software, the data may be displayed at user-defined locations, such as nursing stations.

The Vail 1000 Enclosed Bed is a soft-sided enclosed bed for patients who are at risk to harming themselves or others by intentionally or unintentionally leaving the bed unasisted

Vail 1000 Enclosed Bed

To provide added comfort during periods of bedrest by permitting the user to adjust the surface contour of the bed to various positions.

The Model 720 Series Full/Semi Electric and 1120 Full Electric Beds are a series of nursing home beds with an intended function of providing added comfort during periods of bedrest. Additionally they permit the user to adjust the surface contour of the bed to various positions which best suit the specific needs of the bed user. The 720 and 1120 product lines include a steel frame construction with motorized adjustments which are controlled through a pendant. The pendant controls are completely sealed and are available in four or six button configurations. Each series has variety of options and accessories which vary according to model number. Some options include floor locks, lock-out switches and perforated pans. Accessories include various side rails, IV sockets, IV rods and trapeze.

NURSING HOME + LONG TERM CARE SLEEPING SURFACES. TO PROVIDE SUPPORT & COMFORT. TO RESIDENTS OF NURSING HOMES OR LONG TERM CARE Facilities

HOSPITAL BED.

This device is intended for medical purposes in hospitals or nursing homes for use by the staff to adjust the surface contour of the bed using built-in electric motors and wheels for movement of the bed to different locations.

The device includes bed using built-in electric motors and wheels for movement of the bed to different locations.

The Soma™ Safe Transport Bed is to be used for the management of patients who are excessive in size and those who are the most difficult to care for. The use of this device will assure the prevention of personal injury to the patient and staff.

Soma 900 Transport Bed

The subject device is intended to be used as a comprehensive product ideally suited to be used in health care environments. The product may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The product is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. The device is intended to provide significant improvements in caregiving and a safer environment for caregiver and patient

The product consists of mechanical, electromechanical, hydraulic, and electronic components. These may be selected by the caregiver or institution to customize the bed to specific patient population needs.