User's Manual

SIM™ User Manual | Ref Code: SUM | GEN4_0024| Version: 8

1.2 WARNINGS

General Warnings Related to Use of the SIM™ system

WARNING

 The SIM™ system must be used according to its intended use. Refer to section 2.2 Indications for Use.

 A resident in a Long Term Care facility is highly vulnerable to the risks of infection. Dirty or

contaminated equipment is a potential source of infection. Clean the SIM™ pod and SIM™ dock

regularly and systematically, before and after each use. Follow all internal procedures to your

organization, as well as any maintenance procedures, to reduce the risks of infection.

 To reduce the risk of infection, facility standard operating procedures for cleaning, disinfection and

hygiene must be followed at all times. At a minimum you should wash your hands thoroughly before

and after handling any part of the SIM™ system.

 SIM™ is not a substitute for standard care practices. A resident undergoing a continence assessment

should always be monitored by trained and competent personnel. Ensure the resident’s carer is able

and prepared to take suitable action in the event that any part of the SIM™ system experiences a

problem.

 If there is leakage, as there may be with any continence product, there may be a risk of rash, sores

and/or compromise of skin integrity requiring medical intervention during a continence assessment.

The resident’s carer should continually monitor and interact with the resident.

 The SIM™ sensor should not be applied to a resident who has a known pre-existing skin condition,

such as a rash, sores and/or a compromise of skin integrity.

 Some residents may be sensitive to materials used in the SIM™ components. It is important that the

resident’s carer continually monitors and interacts with the resident. If the resident is sensitive to the

materials used in the SIM™ components, discontinue use and contact Simavita.

 If a resident develops a skin irritation as a result of wearing the SIM™ sensor, discontinue use and the

resident’s carer should continually monitor and interact with the resident, and refer to 12.0 SIM™

Contact and Support for contact details.

 The SIM™ pants and SIM™ sensors could potentially pose a biohazard risk after an assessment. The

SIM™ pants and SIM™ sensors should be disposed of, as per standard operating procedures for your

facility.

 The Indicator Lights on the SIM™ pod indicate different events and functions. This User Manual should

be consulted for Indicator Light definitions before determining the relevant user action.

 Ensure SIM™ system components are stored and transported according to SIM™ environmental

conditions as defined in Appendix A.

 The SIM™ pod shall only be charged with the adapter model defined in Electrical Specifications in

Appendix A.