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FM300
WORLD OF MEDICINE FM300 User Manual
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Insufflator for Laparoscopy, Vessel Harvesting, and Colorectal Procedures
P31693 Rev. K
Instructions for Use
en
DRAFT
2
Table of Contents
Table of Contents
5
1 Important User Notes
7
2 Safety Information
8
3 General Information
9
Device Description
9
Intended Use
9
Intended Use and Contraindications
9
Contraindications
10
General Warnings CO Insufflation
10
Warnings
10
Warnings Standard and High Flow/Bariatric Operating Mode
14
Warnings Pediatric Operating Mode
16
Warnings Vessel Harvest Operating Mode
17
Warnings TAMIS Operation Mode
18
General Precautions
19
En
22
Device Setup and Connection
21
Initial Device Setup
21
Fig. 4-1 Device Front
22
Front of the Device
22
Fig. 4-2 Device Rear
23
Gas Connection
23
Rear of the Device
23
Connecting a Gas Bottle
24
Fig. 4-3 Connecting the Gas Supply to the Angled Gas Connector
24
Connecting to Central Gas Supply
25
Gas Supply
25
Fig. 4-4 Setting up the Device
26
Switching Device off
26
Switching Device on
26
Draft
40
Fig. 5-1 Screen Displays
28
Insufflation Tube Sets
28
Monitor with Touch Screen
28
Operating the Device - General
28
Connecting an Insufflation Tube Set
29
Using Gas Heating
30
Fig. 5-2 Smoke Evacuation Indicator
31
Using the Smoke Evacuation Function
31
Fig. 5-3 Connections of the Tube Set with Smoke Evacuation
32
Fig. 5-4 Filling the Gas Humidification Tube
33
Use of Insufflation Gas Humidification Function
33
Fig. 5-5 Insufflation Gas Humidification Indicator
34
Fig. 5-6 Connecting the Pneumoclear to the Device Control
35
Using Device Control
35
Displaying/Selecting Insufflation Operating Mode
36
Setting the Nominal Pressure - All Operating Modes
36
Unlocking Operating Modes
36
Running Function Tests before Device Use
37
Setting the Nominal Flow - All Operating Modes
37
Gas Consumption Display
39
Starting/Stopping Insufflation
39
Desufflation
40
Fig. 5-7 Confirming or Denying Desufflation
40
Operating Modes of the PNEUMOCLEAR™ Insufflator
41
Standard Operating Mode
41
High Flow/Bariatric Operating Mode
43
Pediatric Operating Mode
46
Advanced Flow Operating Mode
48
Vessel Harvest Operating Mode
48
TAMIS Operating Mode
50
Menu (Overview)
51
Automatic Venting System
53
Occlusion
53
Safety Functions
53
Contamination
54
Leakage Detection
54
Care and Maintenance
55
Cleaning the Device
55
Maintenance by Authorized Service Technician
55
Maintenance Intervals
55
Replacing the Fuse
56
Fig. 9-1 Opening the Fuse Holder
57
En
58
Annual Inspection
58
Basic Function Test (in Standard Operating Mode)
58
Electrical Safety Test
58
Fig. 10-1 Pressure Sensor Test Setup
59
Pressure Sensor Test (Standard Operating Mode)
59
Fig. 10-2 Connections for Maximum Device Pressure Test
60
Maximum Device Pressure Test
60
Pressure Monitoring Test (in Standard Operating Mode)
60
Venting Valve Test
60
Gas Flow Rate Test
61
Electrical Connections
62
Electromagnetic Compatibility
62
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
62
Error and Warning Messages
65
Technical Data
67
Draft
69
Accessories
69
Warranty and Service
71
16 Glossary
72
17 Appendix
73
List of Figures en
74
Index
75
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WORLD OF MEDICINE FM300 Specifications
General
Brand
WORLD OF MEDICINE
Model
FM300
Category
Medical Equipment
Language
English
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