EasyOne Pro Operators Manual V02 April 2010

Contents

1

Introduction

5

1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8

5 6 6 6 6 7 13

1.9 1.10

2

4 5

Start-up and Initial Preparation

18 18 19 21 24 26 27 29

Unpacking, Environmental Conditions Equipment Description Preparing the Device Gas Supply Connecting the Keyboard and the Mouse Connecting the Printer Power Inserting the One-Way Valve, barriette™ and spirette™ Switching the Device On, Functional Test

30 33

Performing a Test

36

3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10

Selecting/Adding a Patient Selecting a Test Forced Vital Capacity (FVC/FVL) Vital Capacity (SVC) Maximum Voluntary Ventilation (MVV) Quick Test CO Diffusing Capacity (DLCO) Ending the Test Retrieving/Printing Stored Tests Trend View

36 39 39 50 52 54 55 58 58 61

Editing Patient Data Quality Messages and Quality Grades

63 64

5.1 5.2 5.3 5.4 5.5 5.6

6 7 8 9

14 16 17

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9

3

CE Marking Information Revision History Manual Purpose Intended Audience Styles Safety Information Intended Use Components and Functional Description of EasyOne Pro™ EasyOne Pro™ Flow Sensor Design and Operation DLCO Test Gas Requirements

FVC/FVL Quality Messages and Quality Grades 64 SVC Quality Messages and Quality Grades 67 DLCO Quality Messages and Quality Grades 69 System Interpretation 72 Retrospective Test Assessment, Entering Comments 72 Definition of Important Parameters 75

Switching the Device Off Hygiene, Cleaning, Maintenance, Disposal System Settings Troubleshooting Tips EasyOne Pro™

77 78 83 101 3

Contents

10 11 12

Specifications Order Information Appendix 12.1 12.2 12.3 12.4 12.5 12.6 12.7 12.8

102 104 105

Interpretation 105 Predicted Values 109 GDT Interface 115 Introduction to Adjustment of DLCO Measurements 121 How to interpret TLC from a single breath maneuver 123 Report Designer 125 Electromagnetic Compatibility (EMC) 129 Microsoft Software License Terms for Windows® XP Embedded Runtime 134 12.9 Quick Reference Guide to the Screen Displays 140 12.10 Literature 154

4

EasyOne Pro™

Introduction

1

Introduction

1.1 CE Marking Information „

The product EasyOne Pro™ bears the CE marking CE-120 (notified body SGS) indicating its compliance with the provisions of the Council Directive 93/42/EEC about medical devices and fulfills the essential requirements of Annex I of this directive.

„

The product EasyOne Pro™ sensor has been assigned to class IIa as specified in Annex IX of the Directive 93/42/EEC.

„

The device fulfills the requirements of standard EN 60601-1 "Medical Electrical Equipment, Part 1: General Requirements for Safety" as well as the electromagnetic immunity requirements of standard EN 60601-1-2 "Electromagnetic Compatibility – Medical Electrical Equipment".

„

The radio-interference emitted by EasyOne Pro™ is within the limits specified in EN 55011, class B.

„

The CE marking covers only the accessories listed in the Order Information chapter.

„

Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. X-ray equipment, MRI devices, radio systems, and cellular telephones are possible sources of interference as they may emit higher levels of electromagnetic radiation. Keep the equipment away from these devices and verify its performance before use.

„

The device is suitable for continuous operation.

„

The product fulfills the requiremens of the following standards: EN ISO 14971 IEC60601-1: 2005 ‹ EN 60601-1: 2006 ‹ EN 60601-1-2: 2007 ‹ EN 60601-1-6: 2007 ‹ ‹

„

The country of manufacture is indicated on the device label.

EasyOne Pro™

5

Introduction

1.2 Revision History Edition

Date

Comment

Version V01.01

2008-07-22

Initial Release

Version V01.02

2009-11-23

Revised Edition

Version V02

2010-04-06

Revised Edition

1.3 Manual Purpose This manual contains the instructions necessary to employ the product safely and in accordance with its function and intended use.

1.4 Intended Audience This manual is geared for clinical professionals. Clinical professionals are expected to have working knowledge of medical procedures, practices, and terminology as required for completing these examinations.

1.5 Styles Keys (softkeys and hardware elements) are represented in bold print, e.g. New Patient, Select Patient. Terms appearing on the display and product names are italicized, e.g. Last Name, First Name, EasyOne Pro™.

6

EasyOne Pro™

Introduction

1.6 Safety Information General Information „

This manual is an integral part of the device. It should be available to the equipment operator at all times. Close observance of the information given in the manual is a prerequisite for proper device performance and correct operation and ensures patient and operator safety. Please note that information pertinent to several chapters is given only once. Therefore, read the manual once in its entirety.

„

To ensure patient safety, the specified measuring accuracy, and interference-free operation, we recommend using only original accessories available through ndd. The user is responsible if using nonndd accessories.

„

ndd is responsible for the effects on safety, reliability, and performance of the device, only if assembly operations, extensions, readjustments, modifications, or repairs are carried out by ndd or by ndd-authorized personnel ‹ the device is used in accordance with the instructions given in this manual. ‹

„

The warranty does not cover damage resulting from the use of unsuitable accessories and consumables from other manufacturers.

„

Always consult with ndd, if you intend to connect equipment not mentioned in this manual.

„

Components and accessories must comply with the applicable IEC 60601 safety standards and/or the configured system must comply with the collateral standard IEC 60601-1-1 "Requirements for the safety of medical electrical systems".

„

The power cord must be an approved type acceptable to the authorities in the country where the equipment is used.

„

All publications are in conformity with the device specifications and standards on safety of electromedical equipment valid at the time of printing. All rights are reserved for devices, circuits, techniques, software programs, and names appearing in this manual.

„

No part of this manual may be reproduced without written permission from ndd.

© 2009 ndd Medizintechnik AG, Technoparkstr. 1, CH-8005 Zürich, Switzerland

EasyOne Pro™

7

Introduction

Definitions In this manual the safety information is classified as follows: Danger indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury.

Warning indicates a hazard. If not avoided, the hazard can result in death or serious injury.

Caution indicates a potential hazard. If not avoided, the hazard may result in minor injury and/or product/property damage.

Safety Notices Danger Explosion Hazard-EasyOne Pro™ is not designed for use in areas of medical locations where an explosion hazard may exist. Explosion hazards may result from the use of flammable anesthetics, skin cleansing agents or disinfectants. Great care must be exercised when the system is used in an oxygen-enriched atmosphere. The atmosphere is considered to be oxygen-enriched when the room air contains more than 25% of oxygen or nitrous oxide.

8

EasyOne Pro™

Introduction

Warning Shock Hazard- ‹

Before using the system, make sure that it is in correct working order and operating condition. Check the cables and connectors, in particular, for signs of damage. Replace damaged cables and connectors immediately, before use.

‹

Do not expose EasyOne Pro™ to direct sunlight to prevent system components from reaching inadmissible, high temperatures. Furthermore, EasyOne Pro™ has no additional protection against the ingress of humidity.

‹

When disconnecting the device from the power line, remove the plug from the wall outlet first, before disconnecting the cable from the device. Otherwise there is a risk of coming in contact with line voltage by inadvertently introducing metal parts in the sockets of the power cord.

‹

Do not use multiple portable socket outlets (MPSO) to connect the devices to the power line.

‹

Printers operated in the patient vicinity must meet the requirements of IEC 60601. If they do not, they must be modified and be connected to earth ground (PE, potential equalization).

‹

All devices of a system must be connected to the same power supply circuit. Devices that are not connected to the same circuit must be electrically isolated when operated, e.g., with an isolated RS232 interface (this is not a requirement in the USA).

‹

Devices may be connected to other devices or to parts of systems only when it has been made certain that there is no danger to the patient, the operators, or the environment as a result. In those instances where there is any element of doubt concerning the safety of connected equipment, the user must contact the manufacturers concerned or other informed experts to find out whether there is any possible danger to the patient, the operator, or the environment as a result of the proposed combination of equipment. Standards IEC 60601-1-1/ EN60601-1-1 must be complied with in all cases.

EasyOne Pro™

9

Introduction ‹

Liquids must not be allowed to enter the device or the sensor. Devices and sensors into which liquids have penetrated must be immediately cleaned and checked by a service technician, before they can be reused.

‹

Do not open the device or the sensor. There are no userreplaceable components inside the device or the sensor.

‹

Do not insert objects of any kind into the device. They may touch live components and you might suffer an electric shock, cause fire, or damage the device.

Warning Patient Hazard-The operator must be trained in the use of the device. Patient Hazard-Before performing any tests on patients, refer to the ATS/ERS Taskforce recommendations (literature [11] ("Literature" on page 154). Patient Hazard-Custom configured reports bear the label Custom Report at the bottom of each page. The user is responsible for the content and use of all custom configured reports. Patient Hazard-Do not touch the accessible contacts of connectors located at the rear panel and the patient at the same time. Patient Hazard, Equipment Damage-Do not modify EasyOne Pro™ in any way. Patient Hazard-When used at 230-240 V, 60 Hz equipment must be connected to a center-tapped 240 V single phase transformer (US requirement). Risk of Infection-Follow all cleaning procedures carefully, and thoroughly inspect the components after they are cleaned and before each patient is tested. Cleaning residue, particulate matter, and other contaminates (including pieces of torn or broken components) in the breathing circuit create a safety risk to the patient during test procedures. Aspiration of contaminates can be potentially life-threatening. Risk of Infection-Proper use of the spirette™ and the barriette™ provides a reliable infection barrier. The use of other accessories is not permitted.

10

EasyOne Pro™

Introduction

Cross Contamination Between Patients-The spirette™ is intended for single patient use. Use a new one for each patient to prevent cross contamination between patients. Risk of Poisoning-Observe all information provided by the manufacturers of chemical products required for the use and care of the product. Always keep these chemical products in their original containers to avoid any confusion which may have severe consequences. RF Interference-Known RF sources, such as cell phones, radio or TV stations, and two-way radios, may cause unexpected or adverse operation of this device. Check the device performance before each use. Risk to Persons-If the display is broken, avoid contact with the liquid crystal. Suffocation Hazard-Dispose of the packaging material, observing the applicable waste-control regulations. Keep the packaging material out of children's reach.

Caution Equipment Damage-Before connecting the device to the power line, check that the voltage and frequency ratings of your power line match the values indicated on the device nameplate. Equipment Damage-Protect the equipment from viruses, malware, etc. Always check the USB flash drive for viruses, before connecting it to the equipment. Equipment Damage-Do not set up EasyOne Pro™ in the direct vicinity of a window. Rain, humidity and sunlight may damage EasyOne Pro™. Do not operate EasyOne Pro™ in the vicinity of heating appliances (radiators). Do not block air vents and do not place any objects on the device. Equipment Damage-Do not drop EasyOne Pro™. Equipment Damage-For equipment transport, switch off EasyOne Pro™ and store it in its original packing. Restricted Sale-U.S. Federal law restricts this device to sale by or on the order of a physician.

EasyOne Pro™

11

Introduction

Equipment Symbols

Consult accompanying documents

Single patient use.

0120

CE marked per the Medical Device Directive 93/42/EEC of the European Union. Mains power switch, On/Off

Power button, On / Off

Potential equalization pin

Alternating voltage

The number found under this symbol is the date of manufacture in the YYYY-MM format.

Manufacturer

Type BF applied part This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Consult Operator Manual!

12

EasyOne Pro™

Introduction

1.7 Intended Use The ndd EasyOne Pro™ Respiratory Analysis System is designed for conducting lung function measurements in general or specialist practices or in hospitals. The EasyOne Pro™ Respiratory Analysis System can also be used outside of the laboratory when performing lung function screenings or measurements in occupational medicine. The EasyOne Pro™ Respiratory Analysis System is used to conduct slow and forced spirometry on adults and children starting at age 4. Measurement of Diffusing Capacity of the lung based on CO (DLCO) can be performed on adults and children starting at age 6.

Contraindications to Performing DLCO Tests Do not perform a DLCO test „

in the presence of carbon monoxide toxicity

„

in case of dangerous levels of oxyhemoglobin desaturation without supplemental oxygen

EasyOne Pro™

13

Introduction

1.8 Components and Functional Description of EasyOne Pro™

Fig. 1-1 EasyOne Pro™, block diagram A Mains connector B Power supply unit C Hard disk D Storage disk (backup) E Industrial standard PC F PC ports (USB, LAN, etc.) G Automatic data acquisition H Sensor for ambient temperature and humidity I Pump J Pneumatic system

14

K Gas bottle for DLCO tests L CO sensor M Molar mass sensor N Display with touch screen O Replaceable filter pack P DLCO gas supply tubing Q DLCO valve R Motor block S Sensor

EasyOne Pro™

Introduction

EasyOne Pro™ consists of a compact main unit and a hand-held flow sensor S with removable DLCO valve unit Q. The hand-held sensor is electrically connected to the device. For DLCO tests, a gas supply tube P delivers gas to the DLCO valve. The sensor measures flow velocity, volume and molar mass of the gases that the patient inhales and exhales. The mains connector A connects the device to line power. The gas bottle K supplies the medical gas mixture that is required to perform DLCO tests (normally 0.3% CO, 10% He, 21% O2 in N2). A temperature and humidity sensor H measures the temperature and humidity in the examination room. The device contains an industrial standard PC E (Windows XP embedded) that performs data acquisition, data analysis and storage of test results. The user interface for display and control consists of a flat panel display with touch screen N. If required a keyboard and/or a mouse can be connected to the PC. A pneumatic system J delivers gas to the patient, allows flushing of the DLCO gas delivery hose and draws gas samples from the patient's inspiratory and expiratory breath. The side stream flow used for gas analysis is driven by a pump I. CO gas is analyzed by a sensor based on infrared absorption L. A molar mass sensor M based on ultrasound transit time measurement determines the helium content of the respired air. Note EasyOne Pro™ includes the Touch-It Virtual Keyboard developped by Chessware SA.

EasyOne Pro™

15

Introduction

1.9 EasyOne Pro™ Flow Sensor Design and Operation The ultrasound flow sensor measures the transit time to determine flow velocity, volume and molar mass of the gas (molecular weight x concentration). The illustration below explains the measuring principle: two ultrasound sensors emit very short ultrasound pulses that travel along the transmission path to the opposite ultrasound transducer. Measuring the transit times allows the flow velocity to be determined very accurately and independently of temperature, humidity and molar mass of the gas. Since the measuring principle is based on a digital measurement technique, the sensor requires only one single calibration. The sensor calibration does not change during the sensor's lifetime.

integrated mouthpiece

Fig. 1-2

16

ultrasound sensor 2

EasyOne Pro™ flow sensor

EasyOne Pro™

ultrasound sensor 1

Introduction

1.10 DLCO Test Gas Requirements Caution Patient Hazard, Incorrect Measurements- Observe local regulations. Use only medical-grade gases, if required. Make sure that only ndd-approved gas mixtures are used. If the gases used do not meet the ndd specifications, equipment malfunction may occur and the test results may be incorrect.

Gas mixture: 10% helium, 0.3% carbon monoxide, 18 to 25% max. oxygen, rest nitrogen Accuracy of the gas mixture: ≤2% Note You can purchase all necessary gases and bottles as well as the fittings from your local ndd dealer. Equipment not intended for mobile use can also be used with large gas cylinders. Use only the supplied original tubing to connect the gas bottle to the device. Use only the original gas supply tube to connect the valve unit to the device. Warning Improper handling of gas bottles represents a major risk to persons and the environment. The relevant regulations must be observed without exception. Protect the gas cylinders from falling. The content and fill level must be clearly visible at all times. Valves, fittings, connections and tubing must be free of oil and grease. Have the cylinder inspected regularly by an official test authority. The user is liable for any damage. Close the main valve whenever the gas cylinder is not in use!

EasyOne Pro™

17

Start-up and Initial Preparation

2

Start-up and Initial Preparation

2.1 Unpacking, Environmental Conditions Transport Damage Upon arrival, immediately check that the shipment is complete and undamaged. If you have a complaint, promptly notify the shipping agent and your local ndd dealer. Check each of the following items: the housing the sensor and its connection cable ‹ the valve unit including the overpressure valves and the one-way valve ‹ the gas supply tube ‹ the power cord ‹ the gas cylinder fittings. ‹ ‹

Cleaning Before Initial Use EasyOne Pro™ does not require cleaning before its first use. The gas supply tube and the valve unit are cleaned before shipping, but not disinfected. These parts can be thoroughly cleaned as described in chapter "Hygiene, Cleaning, Maintenance, Disposal" on page 78.

Ambient Conditions Excessive amounts of dust, lint, and miscellaneous clutter around the instrument could result in malfunctions due to internal tubing blockages, overheating of components, clogged ventilation ports, etc. EasyOne Pro™ can be operated under the following ambient conditions: temperature +5 to +40 °C (41 to 104 °F) relative humidity 15 to 95%, no condensation ‹ atmospheric pressure 700 to 1060 hPa. ‹ ‹

Note Also observe the information given in section "Electromagnetic Compatibility (EMC)" on page 129.

18

EasyOne Pro™

Start-up and Initial Preparation

2.2 Equipment Description a

b

c

d

Fig. 2-1 EasyOne Pro™ a Sensor holder, extendible b Sensor cable connection c Connection for gas supply tube to sensor

e

f

d ON/OFF switch e Touch stylus f Sensor (see Fig. 2-3)

EasyOne Pro™

19

Start-up and Initial Preparation

g

h i j k l

m n o

Fig. 2-2 EasyOne Pro™, rear panel g USB ports (keyboard, mouse, printer) h Memory card slot cover (Flash card, see "Data Backup on Memory Card" on page 80) i LAN ports (printer) j Monitor k Serial RS232 ports l Connection for temperature and humidity sensor

20

p

q

m Connection for tube from gas cylinder n Potential equalization pin o Screw to secure the filter pack (must be removed before the filter can be replaced) p Nameplate q Mains connector, mains power switch

EasyOne Pro™

Start-up and Initial Preparation

r

s

t

Fig. 2-3 Sensor r Coupling ring for the gas supply tube s Overpressure valves

2.3

u

v

t One-way valve, barriette™ u Motor block, release button v spirette™

Preparing the Device „

Connect the sensor cable to the device.

Fig. 2-4

Connecting the sensor cable EasyOne Pro™

21