EasyOne Air Operators Manual V03 Feb 2020

Preface

1.

Preface

1.1.

Revision history of the EasyOne Air Operator’s Manual

Revision date

Version

Description

20 February 2020

V03

Revised version reflecting enhanced cybersecurity requirements

19 February 2019

V02

Updated content, alignment with the Operator’s Manuals of other EasyOne products, includes exchanged CE mark due to the transition to a new notified body in the EU

10 April 2018

V1.1

Revised version with minor changes

27 February 2017

V01

Initial release for market launch

 Revision history of the EasyOne Air Operator’s Manual

1.2.

Identification and revision of the EasyOne Air spirometer This revision V03 of the EasyOne Air Operator’s Manual applies to EasyOne Air with a serial number greater than 1,000,000 and with a firmware version greater than V1.13.0. If you are in doubt whether this revision of the Operator’s Manual applies to your particular EasyOne Air sensor, please contact the ndd Servicing Department. You can find the most recent revision of this Operator’s Manual on the ndd website.  Contact information  4 www.ndd.ch For the USA: www.nddmed.com

1.3.

Version history of the EasyOne Connect PC software A comprehensive version history of EasyOne Connect is available on the ndd website. Simply search for “version history” on the ndd website. EasyOne Air requires EasyOne Connect V3.0 or later.  www.ndd.ch For the USA: www.nddmed.com

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 2/105

5

Preface

1.4.

Intended use of the EasyOne Air spirometer The EasyOne Air spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old. The EasyOne Air spirometer is used by general practitioners, specialists, and health care professionals, in hospitals and clinics, in pharmacies, and in clinical settings in occupational medicine.

1.5.

Intended audience of this Operator’s Manual This Operator’s Manual is intended for general practitioners, specialists, and health care professionals. General practitioners, specialists, and health care professionals are expected to have working knowledge of medical procedures, practices, and terminology as required to conduct or interpret diagnostic spirometry tests.

1.6.

Using this Operator’s Manual Read this Operator’s Manual prior to operating EasyOne Air and EasyOne Connect. Store the Operator’s Manual in a safe and easily accessible place.

1.7.

Application Notes for further information You can find further information on specialized topics in Application Notes on the ndd website.  www.ndd.ch For the USA: www.nddmed.com

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 3/105

5

Preface

1.8.

Legal information For devices sold within the European Economic Area, any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Due to continuing product innovation, specifications in this manual are subject to change without notice. © ndd Medizintechnik AG, Zurich, Switzerland. All rights reserved. No part of this manual may be reproduced without written permission from ndd. ndd, ndd new diagnostic design and EasyOne are registered trademarks of ndd Medizintechnik AG. Bluetooth® is a registered trademark of Bluetooth SIG, Inc. PCL® is a registered trademark of Hewlett-Packard Development Company, L.P. Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries.

1.9.

About electromagnetic interference This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This Class B digital apparatus complies with Industry Canada RSS standards.  For the USA, see 47 Code of Federal Regulations Sec. 15.19(a)(3) For Canada, see RSS-Gen - General Requirements for Compliance of Radio Apparatus

1.10.

Contact information ndd Medizintechnik AG Technoparkstrasse 1 CH-8005 Zurich, Switzerland Tel: +41 (0) 44 512 65 00 Fax: +41 (0) 44 512 65 01 www.ndd.ch

ndd Medical Technologies, Inc. 300 Brickstone Square, Suite 604 Andover, MA 01810, USA Tel: +1 978 470 0923 Fax: +1 978 470 0924 www.nddmed.com

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 4/105

5

Preface

1.11.

Product registration Registering EasyOne Air facilitates the handling of warranty claims. To register EasyOne Air, go to the ndd website.  www.ndd.ch For the USA: www.nddmed.com

1.12.

Disposal In the European Union, the product you have purchased should not be disposed of as unsorted municipal waste. Please make use of your local WEEE collection facilities to dispose of this product and otherwise observe all applicable requirements.

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 5/105

5

Table of contents

Table of contents 1. Preface

2 1.1. Revision history of the EasyOne Air Operator’s Manual... 2 1.2. Identification and revision of the EasyOne Air spirometer... 2 1.3. Version history of the EasyOne Connect PC software... 2 1.4. Intended use of the EasyOne Air spirometer... 3 1.5. Intended audience of this Operator’s Manual... 3 1.6. Using this Operator’s Manual... 3 1.7. Application Notes for further information... 3 1.8. Legal information... 4 1.9. About electromagnetic interference... 4 1.10. Contact information... 4 1.11. Product registration... 5 1.12. Disposal... 5

2. Safety information

10 2.1. 2.2. 2.3. 2.4. 2.5.

Classification... 10 General safety information... 10 Safety information regarding electromagnetic compatibility... 13 About requirements for connections to external devices... 14 List of equipment icons... 15

3. First-time setup

17 3.1. 3.2. 3.3. 3.4. 3.5.

List of box contents... 17 About compatible printers... 19 Setting up the physical components... 20 Setting up the EasyOne Air spirometer... 23 Installing or updating the EasyOne Connect software on your PC . . . 24

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 6/105

9

Table of contents

4. Introduction

25 4.1. Introduction to the EasyOne Air spirometer... 25 4.1.1. Overview of EasyOne Air... 25 4.1.2. Overview of the user interface of EasyOne Air... 27 4.2. Overview of features of the EasyOne Connect software... 31 4.3. List of terms and definitions... 31 4.4. List of tests and parameters... 32 4.5. List of abbreviations... 35 4.6. About sources for predicted normal values... 36 4.7. About connectivity and data exchange... 36

5. Cybersecurity

37 5.1. 5.2. 5.3. 5.4. 5.5. 5.6. 5.7.

About cybersecurity... 37 About password policies and password expiration... 37 About periodical software updates and patches... 38 About backups... 38 Escalating in case of a security breach... 38 Dealing with a lost or stolen EasyOne Air or PC... 39 Using EasyOne Air securely – general guidelines... 39

6. Performing spirometry

41

6.1. 6.2. 6.3. 6.4. 6.5.

Overview of the spirometry workflow... 41 About preparation of spirometry and instructions for the patient . . . 42 About quality messages for trials and quality grades for tests... 43 About posts and bronchodilation... 43 Performing spirometry using EasyOne Air stand-alone... 44 6.5.1. Choosing a test and adding a new patient... 44 6.5.2. Choosing a test and selecting an existing patient... 45 6.5.3. Performing a complete test using EasyOne Air stand-alone. . 46 6.6. Performing spirometry using EasyOne Connect in combination with EasyOne Air... 52 6.6.1. Connecting EasyOne Air to EasyOne Connect... 52 6.6.2. Performing a bronchial provocation test using EasyOne Connect in combination with EasyOne Air... 53 6.7. About interpreting results... 54 6.8. List of quality messages and quality grades... 55 6.8.1. About quality messages and quality grades... 55 6.8.2. Quality messages for trials... 55 6.8.3. List of quality grades for tests... 56

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 7/105

9

Table of contents

7. Breathing maneuvers for all available tests

58

7.1. 7.2. 7.3. 7.4. 7.5.

About breathing maneuvers for all available tests... 58 Performing the breathing maneuver for the FVC test... 58 Performing the breathing maneuver for the FVL test... 59 Performing the breathing maneuver for the MVV test... 60 Performing the breathing maneuver for the SVC test... 61

8. Hygiene and cleaning

62

8.1. Avoiding contamination while performing spirometry... 62 8.2. List of cleaning solutions for EasyOne Air... 63

9. Working with patient data and reports

64

9.1. Working with patient data and reports on EasyOne Air... 64 9.1.1. Adding a patient to the database on EasyOne Air... 64 9.1.2. Editing patient data on EasyOne Air... 65 9.1.3. Deleting a patient from the database on EasyOne Air... 65 9.1.4. Exporting data from EasyOne Air... 66 9.1.5. Viewing and printing reports on EasyOne Air... 67 9.2. Working with patient data and reports in EasyOne Connect... 68 9.2.1. Merging two patient data records with EasyOne Connect . . . 68 9.2.2. Copying patient data between EasyOne Air and EasyOne Connect... 69 9.2.3. About the trend view with EasyOne Connect... 70 9.2.4. Assessing tests retrospectively with EasyOne Connect... 71

10. Configuration

72 10.1. Configuration of EasyOne Air... 72 10.1.1. Configurations in the settings menu of EasyOne Air... 72 Description of system settings of EasyOne Air... 72 Description of spirometry settings of EasyOne Air... 73 Description of security settings of EasyOne Air... 77 Description of print settings of EasyOne Air... 78 10.1.2. About performing a firmware update with EasyOne Air... 78 10.1.3. Performing a backup of EasyOne Air... 79 10.1.4. About the information menu of EasyOne Air... 80 10.1.5. About the user menu of EasyOne Air... 81 10.2. Configuration of EasyOne Connect... 82 10.2.1. About user handling and the default password of EasyOne Connect... 82 10.2.2. Activating user handling and administering user accounts. . 83

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 8/105

9

Table of contents

11. Calibration check

84 11.1. Performing a calibration check with EasyOne Air... 84

12. Servicing and troubleshooting

86

12.1. About charging the battery of EasyOne Air... 86 12.2. Checking for correct operation of EasyOne Air... 86 12.3. List of troubleshooting solutions... 86 12.4. About reactivating EasyOne Air after storage... 88 12.5. Exporting logging information... 88

13. Specifications and bibliography

89

13.1. List of specifications for EasyOne Air... 89 13.2. List of specifications for the lithium-ion battery of EasyOne Air... 91 13.3. List of order numbers and accessories for EasyOne Air... 93 13.4. List of system requirements for EasyOne Connect... 93 13.5. List of bibliographic references... 94

14. Index

95

A. Appendix

99 A.1. Specific lung function tests for the USA... 99 A.1.1. About the OSHA test... 99 A.1.2. About the SSA test... 100 A.2. Electromagnetic Compatibility (EMC)... 100 A.2.1. General... 100 Environment... 100 EMC conformance... 100 A.2.2. Safety information... 100 A.2.3. Compliant cables and accessories... 101 A.2.4. Wireless module... 101 A.2.5. Electromagnetic emission... 102 A.2.6. Electromagnetic immunity... 103

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 9/105

9

Safety information

2.

Safety information

2.1.

Classification In this manual, safety information is classified as follows: WARNING WARNING . . . . . . indicates a hazardous situation that, if not avoided, could result in death or serious injury. CAUTION CAUTION . . . . . . indicates a hazardous situation that, if not avoided, could result in minor or moderate injury.

2.2.

General safety information Personnel instruction Electric Shock

Make sure that all personnel are familiar with this Operator’s Manual and have understood its content. Patients and technicians may be exposed to dangerous voltage. Connect only medical-grade power supply released by the manufacturer. To ensure electric safety, connect only equipment, such as printers and networks, that complies with the IEC 60950-1 standard for the electrical safety of IT equipment.

Patient health hazard

Inadequate qualification of personnel who operate EasyOne Air can put the patient’s health at risk. The patient may suffer an asthma attack or a bronchospasm while performing spirometry. EasyOne Air must only be used by qualified personnel. Do not leave the patient unattended while performing spirometry or in between trials. Intended audience of this Operator’s Manual  3

Crosscontamination and adverse reaction

After use, the disposable EasyOne FlowTube can be infectious. Provide means for proper disposal of infectious waste, according to legal requirements.

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 10/105

16

Safety information

False diagnosis

Inadequate qualification of the personnel that operates EasyOne Air can lead to false results, false interpretation, and false diagnosis. EasyOne Air must only be used by qualified personnel. Intended audience of this Operator’s Manual  3

Electric shock Fire

Do not open EasyOne Air. Follow the manufacturer’s recommendation for proper disposal of the battery. Only use an original battery by the manufacturer. Do not store EasyOne Air close to flammable materials like paper or textiles. Disposal  5 List of order numbers and accessories for EasyOne Air  93

False diagnosis

EasyOne Air may be damaged when dropped or during transport. Perform an incoming inspection when you first receive EasyOne Air. If you detect any damage, contact your EasyOne Air distribution partner or the ndd Servicing Department. Especially check the battery for visible damage before use. Do not drop EasyOne Air. If EasyOne Air has been dropped, check for correct operation of EasyOne Air. Checking for correct operation of EasyOne Air  86

Fire due to explosive or flammable gases

If used in the vicinity of flammable gases, the plastic case may catch fire and cause burn injuries to the patient. For preventive measures, make sure that the device is not used near flammable gases (for example, anesthetic agents). If not in daily use, remove the battery from EasyOne Air and store the battery in the original packaging.

False diagnosis

Environment conditions outside the range described in the specifications can cause measurement errors. Use EasyOne Air only within the defined environment specifications for temperature, humidity, and atmospheric pressure/altitude. Observe the limits of storage conditions. Setting up the EasyOne Air spirometer  23 List of specifications for EasyOne Air  89 Configuration of EasyOne Air  72 List of specifications for EasyOne Air  89 About reactivating EasyOne Air after storage  88

False diagnosis

Setup with wrong environment data can cause false results. Verify the environment data that you have set up.

False diagnosis

Electromagnetic fields from other devices may cause disturbances in EasyOne Air.

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 11/105

16

Safety information

False diagnosis

Graphs on the display of EasyOne Connect may be misleading due to unclear curve scaling between different patients. Only conduct result interpretation of curves with a printed report. List of quality messages and quality grades  55

Failed update

An update may fail. Perform backups of the database of EasyOne Air and EasyOne Connect frequently. Performing a backup of EasyOne Air  79

Data loss

Data loss may occur for various other reasons and is generally unpredictable. Backup the database of EasyOne Air frequently. Performing a backup of EasyOne Air  79

False diagnosis

For unforeseen reasons, malfunction of EasyOne Air can lead to false results and false diagnosis. Perform calibration checks periodically. Calibration check  84 Checking for correct operation of EasyOne Air  86

Malfunction

Viruses, malware, and other hazardous software on your PC may adversely affect the performance of EasyOne Connect. Install anti-virus software on your PC.

Malfunction

Damaged components can lead to false results. Make sure that no liquid penetrates into EasyOne Air, for example through the battery compartment or the USB port.

Leakage of acids and explosion

Do not connect the battery improperly. Do not throw the battery into fire. Remove the battery from the battery compartment if you do not intend to use EasyOne Air for a longer period. Avoid mechanical shock to the battery. If the rechargeable battery is damaged, liquids from the battery must not get into contact with skin or eyes. In case of contact with skin or eyes, rinse thoroughly with water and consult a physician. Only charge the battery using EasyOne Air, the power supply released by the manufacturer, and the cradle. Follow the manufacturer’s recommendation for proper disposal of the battery. About charging the battery of EasyOne Air  86 Disposal  5

Malfunction

Servicing must only be carried out by ndd staff or by qualified service personnel of official ndd distributors. Do not open EasyOne Air.

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 12/105

16

Safety information

Malfunction

Non-original accessories and disposables, like respiratory tubes, battery, power adapter, or cables can cause malfunction. Only use original accessories and disposables by the manufacturer. List of order numbers and accessories for EasyOne Air  93

False diagnosis

Non-original respiratory tubes can cause measurement error and false results. You must only use EasyOne FlowTube respiratory tubes by the manufacturer ndd to assure accuracy, long-life, and full warranty coverage.

Excessive heat

Prolonged exposure to direct sunlight, for example in cars, or exposure to other sources of heat may cause the battery to explode. Do not store in places that can exceed temperatures of 50°C or 122°F. Remove the battery and store the battery in the original packaging.

Network connection

Connection of EasyOne Connect to an IT network that includes other equipment could result in previously unidentified risks to patients, operators, or third parties. Subsequent changes to the IT network could introduce new risks and require additional analysis. Changes to the IT network include: • changes in the IT network configuration, • connection of additional items to the IT network, • disconnecting items from the IT network, • update of equipment connected to the IT network, and • upgrade of equipment connected to the IT network. It is your responsibility to identify, analyze, evaluate, and control these risks. IEC 80001-1:2010 provides guidance to address these risks.

2.3.

Safety information regarding electromagnetic compatibility Influence by HF surgical equipment

Electrical devices with a high RF power output during intended use (e.g. High frequency (HF) surgical equipment) should not be operated in parallel with EasyOne Air.

Portable wireless communications equipment

Portable wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkietalkies, etc. can affect EasyOne Air. Keep a distance of at least 30 cm (12 in) to any part of EasyOne Air.

Increased emissions or decreased immunity

Accessories, transducers, and cables other than those specified by the manufacturer or replacement parts for internal components may result in increased emissions or decreased immunity of EasyOne Air.

Proximity to other equipment

EasyOne Air should not be used adjacent to or stacked with other equipment. Should close proximity or stacking be unavoidable, however, the configuration in which it is used needs to be watched closely to ensure that the equipment is functioning normally.

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 13/105

16

Safety information

Interruption of the USB connection

Electrical fast transient coupling to the USB cable or electrostatic discharge on the device may cause an interruption of the USB connection, which is indicated to the user. After reconnecting, the USB connection will work as expected. There is no harm because the data transmission is secured.  See Appendix

2.4.

About requirements for connections to external devices EasyOne Connect is installed on a PC or laptop, to which EasyOne Air is connected via the cradle or wirelessly. The PC or laptop is not part of the equipment supplied by the manufacturer and is considered a requisite accessory that is necessary to use EasyOne Air with the PC software EasyOne Connect. In your capacity as the operator of the medical electrical device, you are obliged to ensure that the specific, applicable safety requirements for the operation of a medical-electrical device are complied with. The following conditions must be met: • All equipment operated in the patient environment must meet the requirements of IEC 60601-1. • All equipment set up outside the patient environment must meet the requirements of the applicable IEC or ISO safety standards (e.g. IEC 60950-1).

 Patient environment

If devices that do not fulfill the requirements of IEC standard 60601-1 are operated in the patient environment, it must be ensured that the maximum allowed touch currents will not be exceeded. The following limits are applicable: • normal condition: 100 μA • with interruption of the (not permanently connected) protective earth conductor: 500 μA Appropriate measures must be taken if these limits are exceeded. Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 14/105

16

Safety information

Suggestions: • additional protective earth connection of the PC or • isolating transformer for the PC or • isolating transformer with built-in power outlet strip for the PC and the devices connected to it EN 60601-1:2006 specifies the requirements for power outlet strips. Bear in mind that the touch currents may vary with the system configuration.

2.5.

List of equipment icons Read usage instructions Follow instructions for use

Do not reuse, i.e., single-patient use (applicable to the EasyOne FlowTube) CE mark including Notified Body Identification Number

Compliance with additional US and Canadian safety requirements for medical electrical equipment Medical electric equipment that includes a radio frequency transmitter and emits non-ionizing radiation Manufacturer

Date of manufacture

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner In the European Union, the product you have purchased should not be disposed of as unsorted municipal waste. Please make use of your local WEEE collection facilities to dispose of this product and otherwise observe all applicable requirements. Instrument classification: Type BF applied part

Class II equipment

For indoor use only

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 15/105

16

Safety information Universal Serial Bus (USB 1.0/1.1, USB 2.0, max. 100 mA)- standard for data transfer, connecting devices, and battery charging, applies to cables and connectors Connection to PC or printer Battery Battery door open position

Power ON/OFF (standby mode)

Connection to power supply

Fragile-handle with care

Do not use if package is damaged

Keep dry

Temperature limit

Humidity limitation

Atmospheric pressure limitation

Serial number Batch code Catalog number

MD

Medical Device Authorized representative in the European Community

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 16/105

16

First-time setup

3.

First-time setup

3.1.

List of box contents The box contains the following items:

B

A

A EasyOne FlowTube respiratory tubes

B EasyOne Air spirometer

 Box contents – top inlay

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 17/105

24

First-time setup

E F A B C G

D

A Battery

B USB Bluetooth adapter

C USB flash drive

D 2x USB cable

E

F

Nose clip

ndd power supply

G Cradle  Box contents – bottom inlay

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 18/105

24

First-time setup

B

A A USB cable micro to type A

B USB cable micro to type B

 The different USB connectors of the two USB cables

The box contains the following documents: • The EasyOne Air Quick Guide • Certificate of Stability The USB flash drive contains the following: • The EasyOne Air Operator’s Manual • The EasyOne Air Quick Guide • Instructional movies • The EasyOne Connect PC software

3.2.

About compatible printers EasyOne Air can print over USB when using the cradle. To print via the cradle, the printer must support the protocols Direct PDF, Postscript, or HP PCL 3 Enhanced. EasyOne Connect can use any printer that is installed on your PC. To print using EasyOne Connect, connect the printer to your PC and not to the cradle.  Description of print settings of EasyOne Air  78 Setting up the physical components  20 Application Note Printer Compatibility List Application Notes for further information  3

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 19/105

24

First-time setup

3.3.

Setting up the physical components WARNING ELECTRIC SHOCK Patients and technicians may be exposed to dangerous voltage. Connect only medical-grade power supply released by the manufacturer. To ensure electric safety, connect only equipment, such as printers and networks, that complies with the IEC 60950-1 standard for the electrical safety of IT equipment. CAUTION ELECTRIC SHOCK, PATIENT HEALTH HAZARD, AND FALSE DIAGNOSIS Damage to casing or broken components may expose the patient or technician to dangerous voltage. Small parts from damaged disposables can be ingested or inhaled by the patient. Measurement errors can cause false diagnosis. Check the device and especially the battery for visible damage before on-site installation and before usage. 1 Unlock and open the battery compartment by turning the lock screw clockwise.

2 Insert the battery into the battery compartment of EasyOne Air.

Operator’s Manual V03 • EasyOne Air • EasyOne Connect © ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch

9000007/03 20/105

24