19
USER INSTRUCTIONS
Symbol definitions
REF
REF
Follow instructions
for use - safety
Consult
instructions for
use�
www�fphcare�
com/950IFU
Manufacturer
Date of
manufacture
Catalogue
reference number
Batch
code
Serial
number
IP21
Type BF
Applied Part
Class II
equipment
Alternating current
Standby
(On/Off)
IP
Classification
Temperature
limitations
Humidity
limitations
USB 2�0
WEEE (Waste
Electrical and
Electronic
Equipment)*
European
representative*
CE Marking
93/42/EEC*
Regulatory
Compliance Mark*
Raise finger guard Date of expiration
Fragile, handle
with care
Keep dry
Recyclable
Caution
Warning
Alarm
Menu
Warning:
hot surface
Alarm audible
pause
Alarm audible
paused
Invasive mode
Mask mode
Optiflow mode
Neonatal mode
Neonatal Invasive
mode
Neonatal
CPAP | NIV mode
Neonatal Optiflow
mode
Sensor cartridge
authentication
failure
Sensor Cartridge
service life warning
Accept
Cancel
Page 1 of 2 Pages
cUL Classified Mark
Doc. No: SYM-201
Revision: B
Created using TMP-80_e
–
Parent procedure SP-233, SP-331
This document is not controlled when printed from the intranet.
Refer to Fisher & Paykel Healthcare intranet for current revision.
Figure 1. cUL Classified Mark for F&P 950
Symbol Use
:
•
The c-UL symbol is a certification mark which indicates compliance to Canadian electrical
safety requirements.
•
In order to apply this c-UL mark, the electrical equipment must have a certifying test report.
The report must align with the following details:
File Number:
E354976
Assessed
Standards:
CSA CAN/CSA-C22.2 NO. 60601-1:14, IEC 60601-1-8:2006 (Second
Edition) + Am.1: 2012.
•
The symbol shall be marked on the electrical device and in the Instructions for Use.
•
The source of the symbol is Underwriters Laboratories Inc. for Type R manufacturers.
The UL symbol consists of the following elements:
•
UL in a circle
•
‘Classified’
•
Scope of certification: ‘C’ for Canada.
•
File number: ‘
E354976
’ (provided in the UL report)
•
Additional certification markings:
‘
MEDICAL
–
GENERAL MEDICAL EQUIPMENT. AS TO
ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
[
standards in scope
]’
•
Attached to this SYM document is a certificate of acceptance for the format of this symbol.
Review and Approval
Please tick if task complete:
Pre-release database done
, File(s) in DRAFT & Closed
Name
Title
Signature
Date
Suzanne Bell
Author
Senior Product
Development Engineer
Amelia Ortiz Rios
Final Approval
Regulatory Affairs
Specialist
MEDICAL
–
GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH
CSA CAN/CSA-C22.2 NO. 60601-1:14,
EN 60601-1-8:2006/AMD.1:2012
E354976
Back arrow
Locked
Unlock
Medical Device*
Prescription only*
c UL Mark*
* symbol displayed on select models
