Medtronic FMET-IM-SYS-S Operator's Manual
FlowMet™
Peripheral Blood Flow Monitoring System
Operator's Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States
and/or in other countries.
FlowMet™
Symbol definitions
Manufacturer
Serial number
Catalog number
Batch code
Caution: Consult accompanying documents
Consult instructions for use at this website
Keep dry
Fragile, handle with care
IPX0 - no claim of protection from water ingress
Type BF applied part
Prescription only
Nonsterile
Do not reuse
MR Unsafe
Not made with natural rubber latex
Does not contain PVC
Class 1 laser product
Quantity
Date of manufacture
Do not discard
3
Contents
1 Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.1 Purpose of the monitoring system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2 Principle of operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4 Intended patient population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.5 Use environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.6 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.1 Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.2 Operational or usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3 Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.1 Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.2 Operational or usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.3 Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4 Potential adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5 Cybersecurity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.1 Wireless features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.2 Use of USB port on tablet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.3 Use of Windows OS passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.4 Use of other software on the tablet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.5 Software updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.6 Identification of cybersecurity risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6 Monitoring system components and specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.1 Monitoring system components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.2 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7 Environmental conditions that affect use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.1 Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.2 Lighting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
8 Setup and shut down instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
8.1 Setup instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
8.2 Exit instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
8.3 Shut down instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
9 Pre-use checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
10 Operating instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
10.1 Attaching the sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
10.2 Removing the sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
10.3 FlowMet software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
10.4 Advanced options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
11 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
11.1 Instructions for cleaning reusable cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
11.2 Instructions for cleaning tablet, typepad, and power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
12 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
13 Storage, transport and disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
13.1 Storage and transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
13.2 Disposal of product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
14 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
14.1 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
14.2 Monitoring system warning prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
14.3 Troubleshooting table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
15 Guidance and manufacturer’s declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
15.1 Electromagnetic compatibility (EMC) declaration tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
15.2 IEC 60601-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
15.3 IEC 60825-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
16 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4
1 Device description
The FlowMet peripheral blood flow monitoring system (Figure 1) measures real-time blood flow rate in the extremities. The monitoring system is comprised of a Microsoft Surface Pro Tablet
(tablet), power supply, FlowMet reusable cable (reusable cable), and FlowMet™ digit flow sensor (sensor). The tablet, power supply and reusable cable are intended for multiple uses and
should not be discarded. The sensor, with its adhesive components, is for single patient use only.
Figure 1. FlowMet peripheral blood flow monitoring system
1.1 Purpose of the monitoring system
The monitoring system is capable of measuring microvascular blood flow rate in fingers or toes. Active monitoring system components include an infrared laser diode and image sensor.
1.2 Principle of operation
The monitoring system directly measures blood flow rate within the full thickness of a digit via dynamic light scattering. Erythrocytes within the blood vessels of the digit scatter incident photons.
The monitoring system projects light through one side of the digit and uses a light sensor on the opposing side to measure how the pattern of light scattered by erythrocytes changes over time.
The speed with which the resulting scattered light pattern changes is proportional to blood flow rate in the interrogated digit.
1.3 Indications for use
The FlowMet is a non-invasive probe that is affixed to the fingers or toes and intended to quantify tissue blood flow rate.
1.4 Intended patient population
The intended patient population for the monitoring system is individuals with vascular disease, such as those with peripheral artery disease.
1.5 Use environment
The monitoring system is intended for use in clinical environments. This most commonly includes operating suites, but may also include other clinical use environments.
1.6 Contraindications
Do not use on patients that present or have known allergies to adhesive tape. The sensor is comprised of both synthetic rubber and silicone adhesives.
Do not use the device in an MR (magnetic resonance) environment, explosive atmosphere, or pressurized chamber.
This device is not defibrillation proof per IEC 60601-1 clause 8.5.5.
2 Warnings
2.1 Environmental
• Explosion hazard. Do not use in flammable environments such as a hyperbaric chamber, oxygen rich environment, or near flammable anesthetics.
• Do not use during magnetic resonance imaging (MRI) scanning.
• Do not use during diathermy or electrocautery.
• Be careful of unexpected signal variation due to radio frequency (RF) emitters (e.g. RFID). If there is suspicion of unexpected signal variation, see Chapter 14, Troubleshooting,
page 16.
• Do not use the monitoring system in overly damp environments (relative humidity 20% to 80% noncondensing).
• Do not use the monitoring system outside of its intended temperature operating range (5°C [41°F] to 23°C [73°F]). Doing so could result in device non-operation or excessively high surface
temperatures, which can cause burns.
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• Do not expose the monitoring system to any liquids besides wipes used for cleaning. Inappropriate exposure of the monitoring system to liquids may result in electrocution or burns.
• Portable RF communications equipment such as antennas, wireless microphones, cordless telephones, Wi-Fi transmitters, Bluetooth radio devices, etc. may affect the functionality of the
monitoring system and should not be placed or operated within 24 in (0.6 m) of the system and its components (tablet, cables, sensor, power supply, and accompanying cables).
• As a light-based system, external lighting can sometimes influence monitoring system measurements. Generally, too much light exposure will trigger a warning from the system; however,
it is possible for external lighting to adversely affect measurements without triggering a system warning. As such, the user should be careful of the lighting within the surroundings. Some
possible sources of light interference are direct sunlight, fluorescent lights, surgical lamps, infrared heating lamps, and bilirubin lamps. These situations can be remedied by shielding the
sensor with an opaque material if necessary.
• Do not autoclave or submerge the equipment in any cleaning solution.
2.2 Operational or usage
• Do not stack any components or accessories of the monitoring system on or close to other equipment that may pose electromagnetic (EM) disturbances or vice versa. If this situation is
unavoidable, the monitoring system itself as well as the equipment it is in close proximity with should be tested prior to use to assure both the monitoring system and the other equipment
are functioning as intended.
• Do not start the monitoring system unless the sensor is applied to a digit (finger or toe). Stop the monitoring system before removing the sensor from the digit. Failure to use the monitoring
system as described in this manual could result in exposure to laser radiation, which is potentially harmful to the eyes. Never stare into the laser beam.
• Carefully route cabling to reduce the possibility of entanglement.
• Cables and accessories of the monitoring system may negatively affect the EMC performance of other devices or equipment and vice versa. Caution should be taken to ensure proper
isolated equipment placement.
• Always attach the sensor as described in this manual. Improper application of the sensor to the digits or application of the sensor to locations other than the digits may damage tissue at
the application site.
• Ensure the sensor is not too tight, especially in the case of patients with poor perfusion. A sensor that is too tight or becomes too tight as a result of edema may lead to inaccurate readings
or tissue damage. Tissue damage may result by way of ischemia followed by subsequent pressure necrosis or skin erosion. The sensor site should be monitored frequently, every 30 min,
for signs of ischemia or any other form of tissue maladies.
• Do not use additional adhesive material or medical tape to affix the sensor to the patient due to potential allergic side effects as well as over-tightening of the sensor, which could lead to
tissue damage by way of ischemia followed by subsequent pressure necrosis or skin erosion.
• The sensor is not a sterile device. It should not be placed on digits with open wounds or compromised tissue.
• The sensor is comprised of adhesive material or medical tape. In the opinion of the medical professional, the sensor should not be placed on digits with compromised tissue where the
sensor removal could cause tissue damage.
• If the sensor begins to feel uncomfortably warm, stop the software and remove the device.
• The sensor is a single patient use disposable device and should not be cleaned or reused. The sensor may be repositioned on the same patient, during a single procedure, provided the
sensor provides adequate adhesion to the digit.
• Always clean the reusable cable between every use with isopropyl alcohol, germicidal wipe, 10% bleach solution, or comparable disinfecting solution.
• During removal of the sensor, be careful of causing damage to the underlying and surrounding tissue where the sensor is attached.
• Before removing the sensor from the digit, examine the digit and its surrounding tissue for any signs of damage or injury which may require special attention.
• The monitoring system is intended for use within a hospital setting and only by trained personnel.
• Even though the reusable cable is cleaned prior to storage, it should be cleaned once again just before use on the patient.
• The tablet is portable but it is intended to be stationary during operation of the monitoring system.
2.3 Equipment
• Do not attempt to remove the attached case on the tablet.
• The components and accessories of the monitoring system should not be exchanged or replaced with parts not included with the monitoring system. Do not substitute the provided power
supply with an aftermarket power supply. Use of components or accessories not included with the monitoring system could result in inaccurate measurements or device non-operation.
• Never use the monitoring system if any of the components exhibit visible defects, discoloration, or signs of damage.
• Do not adjust, repair, open, disassemble, or modify this unit. Injury or equipment damage could occur. If the monitoring system is malfunctioning or appears to be visibly damaged, contact
Medtronic.
• Do not attempt to replace any batteries or fuel cells within the monitoring system. If there is suspected damage to the internal battery (lithium-ion) or fuel cells, Medtronic will replace the
tablet per the conditions stated in the warranty.
• Ensure the tablet and its power supply are at least 6.6 ft (2.0 m) away from the patient.
• The power supply isolates the display and sensor from the supply mains. Ensure there is adequate space to disconnect the power supply if necessary.
• The monitoring system should only be used by trained personnel that have read the manual in its entirety.
• The monitoring system has been designed for use by trained personnel on a patient. The monitoring system has not been designed for taking self-measurements. There are no functions
that the patient can safely use during proper operation of the monitoring system.
• Not following the proper cleaning instructions stated within this manual could lead to permanent damage of the monitoring system or injury to the user or the patient.
• Do not clean or service any parts of the monitoring system while the monitoring system is in use.
• Ensure all devices and components are off and unplugged prior to cleaning.
• While there are no maintenance requirements for the monitoring system, do not clean or service any parts of the monitoring system while the device is in use.
• The provided cables (reusable cable, power supply) were included in EMC testing to demonstrate compliance with regulatory requirements. Use of accessories other than those provided
by Medtronic may result in increased emissions or decreased immunity of the monitoring system and result in improper operation.
• The power supply shipped with the monitoring system is the only power supply certified for use with the monitoring system.
• Do not use the sensor, reusable cable, or any cable with exposed optical or electrical components.
• Do not use discolored or damaged sensors or reusable cables.
3 Precautions
3.1 Environmental
• High-intensity lights (including pulsating strobe lights and direct sunlight) may affect readings.
• Dispose of the device in accordance with applicable laws, regulations, and hospital procedures, including those regarding biohazards, microbial hazards, and infectious substances.
3.2 Operational or usage
• Inaccurate blood flow readings may be caused by:
– Nail polish
– Intravascular dyes
– Digits with unusually large or small size or deformation
– Significant patient motion
– Improper device placement
– Sensor applied too tight
• Accuracy may be affected if too much or too little light is getting to the detector. A corresponding warning prompt will flash on the screen when this is suspected.
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3.3 Equipment
• Do not plug any device into the tablet USB port other than the reusable cable, which has a USB connection.
• Users should set up a Microsoft Windows operating system password on the tablet. Establishing a unique password reduces the risk of compromised device functionality and loss of data
(medical or personal) availability or integrity.
• The tablet included with the monitoring system should only be used to run the FlowMet software. Use of other software or changes to system settings may result in the FlowMet software
exhibiting unpredictable or unstable behavior.
• The monitoring system is shipped with a tamper evident tie affixed to the black hard-shell case. If this tie appears damaged upon receipt of the monitoring system, contact Medtronic.
• Replacement parts or any other component substitutions should not be carried out without contacting Medtronic first.
• Suspected malfunction of any monitoring system components should be brought to the attention of Medtronic. Aside from the suggested remedies listed in Section 14.3, Troubleshooting
table, page 16, there is nothing else the user can do to safely and efficiently remedy the issue.
• Do not soak or immerse any components of the monitoring system in any liquid solution.
• Do not use undiluted bleach or any cleaning solution other than those recommended in Section 11.1, Instructions for cleaning reusable cable, page 16.
• Do not clean or sterilize by means of irradiation, steam, autoclave or ethylene oxide.
• Do not clean with harsh solvents such as acetone or petroleum-based solutions.
• Do not aggressively twist or pull on the sensor while cleaning.
4 Potential adverse events
The potential adverse events (or complications) that may occur or require intervention with the use of this device include, but are not limited to, the following conditions:
• Allergic reaction to adhesive tape
• Burns
• Electrocution
• Entanglement
• Eye damage
• Ischemia
• Pressure necrosis
• Skin erosion
5 Cybersecurity
5.1 Wireless features
Wireless features (Wi-Fi and Bluetooth) on the tablet included with the monitoring system have been disabled. These features should not be enabled by the user, as doing so places the tablet
at risk of introduction of malware and unanticipated software errors. Windows anti-virus and firewall protection are enabled on the tablet. These features reduce the risk of malware and should
not be disabled.
5.2 Use of USB port on tablet
Caution: Do not plug any device into the tablet USB port other than the reusable cable, which has a USB connection.
The reusable cable and sensor connects to the tablet using the tablet’s USB interface. The USB interface is not intended for any uses other than attaching the reusable cable and sensor to
the tablet. Plugging other devices into the USB port may result in introduction of malware and unanticipated software errors.
5.3 Use of Windows OS passwords
Caution: Users should set up a Microsoft Windows operating system password on the tablet. Establishing a unique password reduces the risk of compromised device functionality and loss
of data (medical or personal) availability or integrity.
To set up a Windows OS password, open control panel and select Accounts. Select the account you’d like to add a password for and choose Change your password.
5.4 Use of other software on the tablet
Caution: The tablet included with the monitoring system should only be used to run the FlowMet software. Use of other software or changes to system settings may result in the FlowMet
software exhibiting unpredictable or unstable behavior.
5.5 Software updates
Instructions pertaining to software updates will be provided by Medtronic at the time the software update is released. Questions regarding software updates may be directed to Medtronic.
5.6 Identification of cybersecurity risks
Caution: The monitoring system is shipped with a tamper evident tie affixed to the black hard-shell case. If this tie appears damaged upon receipt of the monitoring system, contact Medtronic.
If cybersecurity risks not described in this manual are identified by the user, contact Medtronic.
6 Monitoring system components and specifications
6.1 Monitoring system components
6.1.1 Reusable components
• Custom hard-shelled case
• FlowMet reusable cable, USB to sensor, 10 ft (3.0 m)
• Microsoft Surface Pro Tablet, Windows 10 OS
• Microsoft Surface typepad (part of the Microsoft Surface Pro Tablet)
• Microsoft Surface Pro power supply
• Pre-installed FlowMet software
6.1.2 Single patient use components (disposable)
• FlowMet sensor
Note: Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone, or in combination with
this device, fall within the scope of one or more of the patents relating to this device.
Note: Except for the sensor, all of the components within the monitoring system are reusable, none are disposable.
Note: The user must follow the instructions outlined for proper cleaning, except for the sensor. See Chapter 11, Cleaning, page 16 for cleaning instructions.
Note: None of the components and accessories within the monitoring system are sterile.
Caution: Replacement parts or any other component substitutions should not be carried out without contacting Medtronic first.
Caution: Suspected malfunction of any FlowMet components should be brought to the attention of Medtronic. Aside from the suggested remedies listed in Chapter 14, Troubleshooting,
page 16, there is nothing else the user can do to safely and efficiently remedy the issue.
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