The Operation and Safety Manual should follow the
FDA Guidance on Medical Device Patient Labeling
Link

Your Manual should be self-contained, comprensive, readable, and
understandable.  Remember that the Manual is part of your design, and
that it is a legal document that is described as "the manual" in the 
Device Release Form

Suggested Content and Sequence (include items below when appropriate):

Title
What it is
What is its Purpose
Table of Contents
Glossary 
Descriptive Information
Purpose of the device (indications for use)
Description of the device (with figure if appropriate)
When the device should not be used (contraindications)
Risks and benefits
Expectations of the device and the procedure associated with the
device
General warnings and precautions
Importance of the need to adhere to a care regimen
Operating Information
Setup instructions
Checkout procedures
Operating instructions
Importance of the need to monitor the activity of the device
Cleaning instructions
Description of maintenance and who should do it
Storage instructions
Expected failure time and mode and its effect on the patient
Instructions on how to safely dispose of the device
Instructions on accessories
Instructions on related, additional devices
Troubleshooting Information
Troubleshooting
Additional Information
Clinical studies
Disease and self-care information
Adverse events
Warranty
Travel or international use
Index
Date of Printing
User Assistance Information
Appendices as appropriate
     Component identification and manuals
     List of parts and sources

Some examples (could be good or bad):
vancam
TouchPad controller
PatientCall device