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This appliance conforms with the Directive 93/42/CEE "Medical Devices"
0123
Guarantee of Quality system for the production and the final control of the products certified by the notifying body TÜV
SÜD Product Service GmbH
Spencer Italia s.r.l.
Tel. +39 0521.541111 / Fax +39 0521.541222 / e-mail: info@spencer.it
User's Manual
Oxymask
Masks for oxygen therapy
INDEX
page 2
page 2
page 4
1
page 5
page 6
page 6
First edition: 22/05/06
Rev.3: 07/07/17
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Summary of Contents for Spencer OXYMASK
- Page 1 Operating instructions page 5 Warnings page 2 Maintenance and cleaning page 6 Product description page 4 Accessories and spare parts page 6 First edition: 22/05/06 Rev.3: 07/07/17 Spencer Italia s.r.l. Tel. +39 0521.541111 / Fax +39 0521.541222 / e-mail: info@spencer.it...
- Page 2 Training routines must be registered on a special register in which the names of those trained, of the trainers, date and place are indicated. This register which will certify the eligibility of the operators to use the Spencer device has to be kept for a period of 10 years after the disposal of the device itself.
- Page 3 As a distributor or end user of products manufactured and/or marketed by Spencer Italia S.r.l., you are strictly required to have a basic knowledge of any legal requirements applying to the devices contained in this supply that are in power in the...
- Page 4 The use of this device, if applied by operators trained to oxygen therapy techniques, does not present any contraindications or collateral effects directly connected with the use of Oxymask. The practice of oxygen therapy has side effects that must be carefully evaluated by the operator taking into consideration the patient's condition and the expected duration of the therapy.
- Page 5 3.5 Reference standards Reference Title of document MDD 93/42/CEE European Directive about Medical Devices Modifications to 90/385/CEE Directive about active implants, Directive 93/42/CEE about MDD 2007/47/CEE medical devices and Directive 98/8/CE about the introduction of biocides onto the market Legislative Decree 24/02/1997, n. 46 Application of the 93/42/CEE Directive about Medical Devices Legislative Decree 25/01/2010, n.
- Page 6 The information contained in this document could be modified without any warning and is not to be intended as a commitment on behalf of Spencer Italia S.r.l. Spencer products are exported to many countries and the same identical regulations are not always valid.
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