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Product Description


 
Title: MEDICAL ELECTRICAL EQUIPMENT
Company: INVIVO CORPORATION - Orlando, FL USA
Product Information: Wireless Alltech Gating System, Model No. WTGU.

Wireless Toshiba Gating System, Model No. WTGS, WTGU.
[Conditions of Acceptability: The products covered in this Report are incomplete in construction features or limited in performance capabilities and are intended for use and evaluation in other products. Consideration should be given to the following when the component is used in or with another product.
1. WTGU unit is integrated into host Toshiba MRI system, therefore no installation/operation instructions and input power rating markings provided on the WTGS unit. End user shall provide proper installation manual in the country specific language.
2. WTGU is not intended for direct connection to the MAINS. Power source shall be isolated from MAINS by RI/DI.
3. Leakage current, PE test and normal temperature test shall be considered for WTGU in end-product evaluation.
4. The wireless Toshiba Gating System (WTGU) REF 453564154951 and Antenna boards (2x) REF 452213305331 are intended to be built into a Toshiba host MRI System and shall not allow the patient and/or operator access.
5. The Wireless ECG Module REF 989803163121 (ECG) and Wireless SpO2 Module REF 989803163111 (SpO2) signals are not intended for use with Patient Monitors or Patient Monitoring Equipment.]
Evaluated to the following:(CAN/CSA-C22.2 No. 601.1) AND ARE IDENTIFIED WITH THE cETL RECOGNIZED COMPONENT MARK
 
 
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