Update: The following sentences were added to the first paragraph: For more information refer to Administration Sets on page 62.Ĭhanges to Chapter 1: Introduction Clause ‘Basic Infusion Safety Information’
Severe injury or death may result from using sets other than those indicated in Q Core’s approved list of products.
Using anything other than administration sets regulatory cleared and labeled for use with Sapphire infusion system, may result in an operation that is not within the constraints and parameters of the device. The list of regulatory cleared sets needs to be obtained from the official manufacturer’s publication such as the manufacturer’s website, catalog or any other formally published document. Alternatively, administration sets from different manufacturers that are regulatory cleared and labeled for use with the Sapphire infusion system, can be used as well. Update: The warning was replaced with the following: Use Q Core standard administration sets listed here or in Q Core’s approved list of products: Update: An additional standard was added to the Compliance and Classification section IEC 6 – Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.Ĭhanges to Chapter 1: Introduction Clause ‘Proper Use of the Pump’ Sub-clause Administration Sets Update: The third paragraph was updated with an added intended use – air transportation The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical air and ground transportation.Ĭhanges to Chapter 1: Introduction Clause ‘Safety and Compliance Information Sub-clause ‘Safety and compliance information’ Note: The use of Administration sets manufactured by ICU Medical is approved for sale through March 2023.Ĭhanges to Chapter 1: Introduction Clause ‘Product Overview and Indications’ The list of regulatory cleared sets needs to be obtained from the official manufacturer’s publication such as the manufacturer’s website, catalog, or any other formally published document. Update: The following sentences were added to the end of the first paragraph:Īlternatively, administration sets from different manufacturers that are regulatory cleared and labeled for use with the Sapphire infusion system, can be used as well.
#Elnapress Sapphire Manual manual#
**P/N 1502 refers to User Manual for Sapphire Rev 13 Ver01
#Elnapress Sapphire Manual update#
Send us an email or give our customer service team a call.AND DEDICATED INFUSION PUMPS – ADDENDUM 3ġ502* (Rev 13 Ver01), Update to Sapphire SW 13.23.2 andĬlarification regarding administration sets of different manufacturers If you don't see your model listed below, we would love to help. From Elna presser feet to instruction manuals, we have your sewing needs covered. Repairing your machine has never been easier! Shop our extensive selection of genuine and replacement Elna sewing machine and serger spare parts.