Rostrum Medical Innovation Inc.
Electrical Listing Program
- Rostrum Medical Innovation Inc.
- Medical Electrical Equipment
- Vancouver, B.C. Canada
- E10581
- E10581-2203
- September 12, 2022
- N/A
- N/A
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AAMI ES60601-1
CAN/CSA-C22.2 No. 60601-1:14 -
The VQm Pulmonary Health Monitor (PHM), Medical Electrical Equipment, Class I, Cord-set connected, Mobile
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Products are marked in a permanent manner where it is readily visible after installation with the following:
a) Manufacturer’s name or trademark
b) Model designation
c) Month and year of manufacture
d) Product ratings: voltage, frequency, amps
e) QAI file Number: E10581
f) The wording “Conforms with CAN/CSA 60601-1 and AAMI ES60601-1”
g) Warning markings as required by the standards in English and French
h) QAI logo shown here:
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Model Rating Description Environmental Locations VQm-S06 100-240V~, 50/60Hz, 2A Pulmonary Health Monitor (PHM) Dry Location only Notes:
1. Requirements for biocompatibility (Subclause 11.7) and electromagnetic compatibility (Clause 17) are not evaluated (N/E) in this evaluation. Consideration shall be made by the Manufacturer in the end use.
2. Hazards resulting from intended physiological effects or from the abnormal use of the Product are not considered in this evaluation.
3. The Manufacturer’s risk management file for the Product is reviewed in accordance with the requirements of ISO 14971 as part of this evaluation. The Manufacturer’s risk management decisions inform the applicable test and evaluation requirements. The Manufacturer shall notify QAI of any changes or revisions in the risk management file that affect the compliance of the Product with the applicable Standards.
4. If this Product is subsequently combined with other equipment through a functional connection or by use of a multiple socket-outlet, consideration of the requirements of Clause 16 for Medical Electrical Systems shall be made by the Manufacturer or the Responsible Organization in the end use.
The materials, products or systems listed in this directory have been qualified to bear the QAI Listing Mark under the conditions stated with each Listing. Only those products bearing the QAI Listing Mark are considered to be listed by QAI.
The standard herein listed is the currently accepted version within the relevant certification scheme, code or other requirements unless otherwise noted. Transition periods may apply. Upon request, QAI will provide information about the validity of any of its certifications.
No warrantee is expressed or implied, and no guarantee is provided that any jurisdictional authority will accept the Listing found herein. The appropriate authorities should be contacted regarding the acceptability of any given Listing.
Visit the QAI Online Listing Directory located at www.qai.org for the most up to date version of this Listing and to validate that this QAI Listing is active. Questions regarding this listing may be directed to info@qai.org. Please include the listing number in the request.
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