BIO-MED DEVICES TV-100 User Manual

104 pages

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Bio-Med Devices Inc.

TV-100 Operator's Manual

Catalog Number: 5501

Revision: 041122

61 Soundview Road, Guilford, CT 06437

Telephone: 800-224-6633

Fax: 203-458-0440

Website: www.biomeddevices.com

Table of Contents3
About this Manual7
Scope7
Indications for Use / Intended Use7
Contraindications7
Organization of this Manual7
Chapter 1: Installation7
Chapter 2: Principles of Operation8
Chapter 3: User Interface8
Chapter 4: Performance Checkout Procedures8
Chapter 5: Alarm Handling8
Chapter 6: Troubleshooting8
Chapter 7: Specifications8
Symbols9
Abbreviations12
Safety Statement14
Warnings, Cautions, and Notices15
Document Conventions for Warnings, Cautions, and Notices15
Warnings15
Cautions19
Notices20
Contact Information22
Recommended Maintenance Schedule23
Chapter 1: Installation24
Unpacking24
Accessories24
Cleaning and Sterilization25
LCD Touchscreen Keypad25
Patient Circuit25
Batteries26
Battery Overview26
Battery Installation and Initial Charge28
Patient Circuit Connection29
USB Dock / Software Update Connection30
Training Recommendations30
Chapter 2: Principles of Operation31
General Overview31
Phases of Breath32
Inspiration32
Expiration32
Breath Types33
Assisted Breath33
Mandatory Breath33
Manual Breath33
Sigh Breath33
Spontaneous Breath34
Ventilation Controls34
Volume Control34
Pressure Control35
Pressure Support37
Ventilation Modes37
A/C Mode (Assist/Control)37
CPAP Mode (Continuous Positive Airway Pressure)37
NIV Mode (Non-Invasive Ventilation)38
SIMV Mode (Synchronized Intermittent Mandatory Ventilation)39
PRVC-AC Mode (Pressure Regulated Volume Control - Assist Control)40
Ncpap/Hfnc (High Flow Nasal Cannula) Mode41
Apnea Detection41
Standby Mode42
Oxygen Delivery42
Oxygen Controls42
Oxygen Source42
Oxygen43
Chapter 3: User Interface44
Physical Interface44
Case Overview44
Graphical User Interface (GUI)46
Startup46
Setup Assistant49
Popup Menus51
Status Bar55
Main Page58
Parameters60
Alarms Page64
Monitoring Page67
Lung Mechanics Page68
Graphs Page69
Tools Page71
Chapter 4: Performance Checkout Procedures73
General Overview73
Touchscreen Calibration73
Oxygen Calibration74
Leak Test75
Compliance Measurement76
Audio & Alarm Test78
Resistance Measurement78
Chapter 5: Alarm Handling80
General Overview80
High Priority Alarms80
Medium Priority Alarms81
Alarm Silence and Alarm Inhibition81
Alarm Silence81
Alarm Inhibition81
Displaying Alarms82
Patient Parameter Alarms82
Alarms Tab82
Warning Popup82
Alarm Parameter Ranges and Alarm Limits85
Default Alarm Values86
Chapter 6: Troubleshooting89
Chapter 7: Specifications90
Specifications90
Default Parameter Values91
Operating and Storage / Shipping Environment95
Electrical Specifications95
Physical and Material Characteristics95
Pneumatic Characteristics96
60601-1 Safety Ratings97
AC Adapters and Inverters97
Land Operation98
Air Operation - Fixed or Rotary Wing Aircraft98
Inverter Operation98
EMC Compatibility99
Additional Guidance and Manufacturer's Declaration - Electromagnetic Emissions/Immunity99
Device Lifetime & End-Of-Life Disposal102
Disassembly Hazards (for Service or EOL Device Disposal)103
Addendum a104
Additional Information Per IEC 60601-1 & 60601-1-8 Standards104

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BIO-MED DEVICES TV-100 Specifications

General

Brand	BIO-MED DEVICES
Model	TV-100
Category	Medical Equipment
Language	English

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