ApneaGraph Spiro User Manual without ETL

ApneaGraph® Spiro User Manual Document number MAN 001

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ApneaGraph® Spiro

User Manual

Copyright © 2014-2017 Spiro Medical AS


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ApneaGraph® Spiro User Manual

Version 2.16 Date 30 May 2018 Copyright © 2014-2018 Spiro Medical AS All rights reserved Manufactured by Spiro Medical AS Nattlandsveien 8 NO-5093 Bergen Norway Website: www.spiromedical.com

Copyright Notice

This manual is copyright © by Spiro Medical AS.

Disclaimer

This document may contain typographical errors or technical inaccuracies. Spiro Medical does not

accept any liability for the use or misuse whether direct or indirect of the products, or for damages

arising out of the use of or inability to use the products. Users must accept all responsibility for any

results obtained by or concluded from data obtained by the products including software from Spiro

Medical. All clinical conclusions and decisions that are based on the use of this product are the

responsibilities of the user.

https://spiromedical.sharepoint.com/Mark%20III%20Development/Library%20under%20Document%20Control/www.spiromedical.com


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Table of Contents

1 Terms and Definitions ...........................................................................................................................5

2 Introduction ..........................................................................................................................................5

2.1 Scope .............................................................................................................................................5

2.2 Intended Use .................................................................................................................................5

3 Intended Medical Indication .................................................................................................................6

4 Warnings and Cautions for Use ............................................................................................................6

4.1 Catheter ........................................................................................................................................7

4.2 Pulse Oximeter ..............................................................................................................................8

4.3 Battery ...........................................................................................................................................8

4.3.1 Recommendations and Warnings .........................................................................................8

4.4 Disposal .........................................................................................................................................9

4.5 Contraindications ..........................................................................................................................9

5 Device Description ............................................................................................................................. 10

5.1 Torso Unit (EL-0019) .................................................................................................................. 10

5.2 Catheter Unit (EL-0030/31/32/33) ............................................................................................. 11

5.3 Neck Unit (EL-0021) ................................................................................................................... 12

5.4 Wrist Unit (EL-0020) ................................................................................................................... 14

5.5 Battery (EL-0002) ....................................................................................................................... 14

5.6 Battery Charger (EL-0017) .......................................................................................................... 14

6 Functional Description ....................................................................................................................... 15

6.1 Battery Insertion ........................................................................................................................ 16

6.2 Installation of Torso Unit ........................................................................................................... 16

6.3 Installation of Wrist Unit ............................................................................................................ 17

6.3.1 SpO2 Sensor Mounting ...................................................................................................... 17

6.4 Installation of Neck Unit ............................................................................................................ 17

6.5 Installation of Catheter Unit ...................................................................................................... 19

6.5.1 Insertion of Catheter .......................................................................................................... 19

6.6 Device Configuration .................................................................................................................. 20

6.7 Indicator Lights ........................................................................................................................... 22

6.8 Data download ........................................................................................................................... 23

6.9 Change of SD Card ...................................................................................................................... 23

7 Maintenance and Storage .................................................................................................................. 24


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7.1 Environmental Conditions ......................................................................................................... 24

7.2 Battery Charging ........................................................................................................................ 24

7.3 Calibration .................................................................................................................................. 24

7.4 Cleaning and Disinfection .......................................................................................................... 24

7.4.1 Catheter ............................................................................................................................. 24

7.4.2 SpO2 Sensors...................................................................................................................... 25

7.5 Battery Storage .......................................................................................................................... 25

7.6 Service ........................................................................................................................................ 26

7.7 Service and Shelf Life ................................................................................................................. 26

8 Compatible Sensors and Devices ....................................................................................................... 26

9 Training .............................................................................................................................................. 27

10 Specifications ..................................................................................................................................... 27

10.1 Torso Unit ................................................................................................................................... 27

10.2 Catheter Unit.............................................................................................................................. 28

10.3 Body Position ............................................................................................................................. 29

10.4 Oximeter .................................................................................................................................... 30

10.5 Actimeter ................................................................................................................................... 31

10.6 Contact Microphone .................................................................................................................. 31

10.7 Airborne Sound Microphone ..................................................................................................... 32

10.8 Battery ........................................................................................................................................ 32

10.9 Bluetooth® Radio Link ................................................................................................................ 33

10.10 Regulatory Information .......................................................................................................... 33

10.10.1 Product Labels ................................................................................................................ 34

10.11 EMC Compliance .................................................................................................................... 37

10.12 Standards ............................................................................................................................... 39

10.13 Performance Testing and Validation Summary ..................................................................... 39

11 Trouble Shooting ................................................................................................................................ 40


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1 Terms and Definitions

See endnotes.

2 Introduction

2.1 Scope

This manual covers the APNEAGRAPH® SPIRO device and its components along with external sensors

and devices that have been validated with the system. It does not cover the software application

needed for device configuration, data download, review and/or analysis.

2.2 Intended Usei

The APNEAGRAPH® SPIRO device is intended for recording of physiological signals during sleep. The

APNEAGRAPH® SPIRO device is for CONTINUOUS OPERATION iifor a maximum of 8 hours of data

acquisition, or one full night of sleep.

The device is intended for patients between 15 years and 75 years. In case of children between 5 and 15

years, parents or other adults must sleep or stay in the same room as the child.

The device is not recommended for children under 5 years of age.

The patient must be capable of removing the ApneaGraph® equipment including straps without any risk

of strangulation or entanglement.

The intended parts of the body are

• Oesophagus (catheter)

• Nose (catheter)

• Pharynx (catheter)

• Neck (microphone)

• Wrist (oximeter and actimeter)

• Finger (SpO2 sensor)

The intended environments are hospitals, institutions, sleep centres, sleep clinics, or other test

environments, including the patient’s home.

The device is to be mounted by a doctor, a nurse or specially trained personnel – at a clinic or a doctor’s office. It is to be used in a clinic, a sleep laboratory or at home and dismantled in a clinic.

The equipment must be installed and put into service in accordance with the information in this manual.

The device does not require any operations or intervention by the patient.


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3 Intended Medical Indication

Diagnosis of SRBDiii/RDIiv, AHIv, OSAS viand RERAvii.

4 Warnings and Cautions for Use

a. The APNEAGRAPH® SPIRO device does not have ESSENTIAL PERFORMANCE viiiaccording to IEC

60601-1. That means that its absence or degradation will not result in an unacceptable risk.

b. The APNEAGRAPH® SPIRO system is to be operated by skilled health care professionals.

c. In order to maintain the safety of the APNEAGRAPH® SPIRO equipment, no modifications are

allowed.

d. In case diagnostic data is to be used in medical certification to drive a car, an airplane, etc. –

make sure that the patient do not move the equipment to another (healthy) person in order to

produce acceptable (and false) results.

e. Do not use this device during use of strong electromagnetic sources, MR or MRI equipment, CT

equipment, X-ray equipment or in the presence of flammable anaesthetics.

f. This device complies with the international standard IEC 60601-1-2 for electromagnetic

compatibility for medical electrical equipment and/or systems. This standard is designed to

provide reasonable protection against harmful interference in a typical medical installation.

However, because of the proliferation of radio-frequency transmitting equipment and other

sources of electrical noise in healthcare and other environments, it is possible that high levels of

interference due to close proximity or strength of source might disrupt the performance of the

device.

g. Use of this equipment adjacent to or stacked with other equipment should be avoided because

it could result in improper operation. If such use is necessary, this equipment and the other

equipment should be observed to verify they are operating normally.

h. Use of accessories, transducers and cables other than those specified or provided by the

manufacturer of this equipment could result in increased electromagnetic emissions or

decreased electromagnetic immunity of this equipment and result in improper operation.

i. Portable RF communications equipment (including peripherals such as antenna cables and

external antennas) should be no closer than 30 cm (12 inches) to any part of the medical

equipment including cables specified by the manufacturer. Otherwise, degradation of this

equipment could result.

j. Use the equipment only as described in this manual, secured to the body as described herein. If

not, unreliable data may be the result.

k. The APNEAGRAPH® SPIRO device is not designed to be safe for use by pacemaker patients.

l. Carefully route cables and connections to reduce the possibility of entanglement or

strangulation.

m. The devices and belts should be worn over clothing.

n. Straps and belts for fastening devices are single use. Repeated use may cause wear that results

in equipment falling off.


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o. Do not use damaged equipment, sensors or accessories. Instruct patient that if equipment,

sensors or accessories are damaged after installation, equipment should be removed

immediately and returned to clinic.

p. Avoid spilling of liquid on equipment and instruct patients to avoid spilling while drinking with

the device attached to the body. Spilling of liquid may result in malfunction.

q. Take care when cleaning with liquid as to avoid liquids entering the units. This may result in

malfunction.

r. The device and its accessories should be removed from the patient before download of data.

Never open the Torso Unit while carried by the patient.

s. Do not use parts or equipment not described in this manual. External equipment intended for

connection to signal input, signal output or other connectors shall comply with the relevant

product standard e.g. IEC 60950 for data processing equipment and the IEC 60601-1 for medical

electrical equipment. All combinations of equipment must be in compliance with IEC60601-1

system requirements. Anyone connecting additional equipment to signal input ports configures

a medical system, and, therefore, is responsible that the system complies with the requirements

of the system standard IEC60601-1. Any equipment not certified in accordance with IEC 60601-1

shall be kept outside the patient environment.

t. The APNEAGRAPH® SPIRO device and accessories must be removed from patient before use of

the USB connector.

u. The USB connector shall only be used for the purpose of downloading data from the device.

v. It is possible for any device to malfunction; therefore, always verify unusual data by performing

a formal patient assessment.

w. Note that the signal from the contact microphone depends very much on the pressure applied

when fixing the microphone to the skin. Signals from two different recordings – even on the

same patient – can therefore not be compared quantitatively.

x. In case connectors become loose (cable connectors do not click in place in the Torso unit), these

should be replaced by manufacturer.

y. Please read this manual carefully before use.

4.1 Catheter

a. Handle the catheter with care, it is a delicate instrument with extremely small and sensitive

sensors,

b. keep the bending radius greater than 6 cm at all times,

c. store the catheter according to instructions in section 7.1,

d. always inspect the catheter before use, never use a catheter with visible damage,

e. before insertion, make sure there are no sharp edges along the catheter,

f. never autoclave the catheter,

g. make sure that a catheter that is going to be reused on a new patient, is cleaned and disinfected

according to instructions herein. Never use the same catheter on two patients without proper

cleaning and disinfection,

h. the catheter has been tested and certified for use with certain disinfection liquids, see section

7.4.1.


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4.2 Pulse Oximeter

a. The pulse oximetry system might misinterpret motion as good pulse quality. Minimize finger

motion or change the type of sensor being used.

b. Do not fasten the pulse oximeter module too tightly around the wrist. Inaccurate readings and

patient discomfort could be the result.

c. To prevent the SpO2 sensor from falling off secure the wire with medical tape.

d. Do not use damaged sensors. If a sensor is damaged in any way, discontinue the use

immediately and replace the sensor.

e. Factors that may degrade pulse oximeter performance include the following:

o excessive ambient light

o excessive motion

o moisture in the sensor

o improperly applied sensor

o artificial nails

o poor pulse quality

o sensor not at heart level

o fingernail polish

4.3 Battery

The EL-0002 Rechargeable Lithium Ion Battery complies with international safety and transportation

standards as it meets the requirements of IEC62133 and UN38.3. The battery is excepted from

Dangerous Goods regulation which significantly reduces the cost and complexity associated with

transportation.

Only batteries delivered by Spiro Medical will work for the ApneaGraph® Spiro device.

4.3.1 Recommendations and Warnings

The following are recommended for the Spiro Medical EL-0002 battery.

a. The battery must be charged before use. Always use the correct charger supplied by Spiro

Medical.

b. Do not dismantle, open or shred the battery.

c. Do not expose cells or batteries to heat or fire. Avoid storage in direct sunlight.

d. Do not short-circuit a cell or a battery. Do not store cells or batteries haphazardly in a box or drawer where they may short-circuit each other or be short-circuited by other metal objects.

e. Do not remove a cell or battery from its original packaging until required for use.

f. Do not subject cells or batteries to mechanical shock.

g. In the event of a cell leaking, do not allow the liquid to come in contact with the skin or eyes. If contact has been made, wash the affected area with copious amounts of water and seek medical advice.

h. Do not use any charger other than that specifically provided for use with the equipment.


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i. Observe the plus (+) and minus (–) marks on the cell, battery and equipment and ensure correct use.

j. Do not use any cell or battery, which is not designed for use with the equipment.

k. Keep battery out of the reach of children.

l. Keep battery clean and dry.

m. Wipe the cell or battery terminals with a clean dry cloth if they become dirty.

n. Do not leave a battery on prolonged charge when not in use.

o. After extended periods of storage, it may be necessary to charge and discharge the cells or batteries several times to obtain maximum performance.

p. Use only the battery in the ApneaGraph® Spiro system. Note that the ApneaGraph® Spiro will only accept the EL-0002 battery.

q. Remove the battery from the equipment when not in use for some time.

r. Batteries must be recycled or disposed of properly. Follow local regulations and ordinances for the disposal of the batteries. Recycle facilities may not be available in all areas.

Note that there is a “bug” in the charger unit; if the battery is removed and quickly reinserted, it is indicated as fully charged (green light) even if it is not fully charged. This is a fault that is due to an internal electronic component and the producer of this component has no intention of fixing it, so this is something we have to live with.

4.4 Disposal Equipment parts must be recycled or disposed of properly following local regulations for hospital waste. Follow local regulations and ordinances for the disposal of the batteries. Recycle facilities may not be available in all areas. Batteries must be recycled or disposed of properly. Follow local regulations and ordinances for the disposal. Recycle facilities may not be available in all areas. Equipment may also be returned to Spiro Medical.

4.5 Contraindications

• The APNEAGRAPH® SPIRO device is not intended for complete automatic diagnosis. The clinician

should always review the data and the proposed diagnosis.

• The APNEAGRAPH® SPIRO device is intended for monitoring of sleep and breathing only.

• The APNEAGRAPH® SPIRO device should not be used on a patient using a pacemaker.

• The APNEAGRAPH® SPIRO device is not intended for monitoring active patients or for prolonged

use longer than one full night.


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5 Device Description

Figure 1 System block diagram. Green is not part of the system. Dotted line represents Bluetooth wireless communication. Dashed lines means optional equipment. Yellow means sensors. Blue means equipment units.

5.1 Torso Unit (EL-0019)

The Torso unit covers the following functions:

• Acquires data from various sensors in Wrist Unit, Neck

Unit, Catheter Unit.

• Acquires data from internal sensors; battery fuel gauge,

body position sensor.

• Records data on internal Micro SD card.

• Contains real time clock that controls start and stop of

automatic recording.

• Super capacitorix for backup of energy to real time clock in

case battery is removed for a short time.

• Contains Li-Ion battery for power supply. It powers the

entire system.

• Contains LEDs xfor signalling of status.

• Contains USB xi 2.0 connection for data download and

setup via PC.

• Contains BLExii radio link for transfer of status signals to a

compatible device.

The Torso Unit Real Time Clock is automatically synchronized to

the PC xiiiclock when set up for a new full night recording.

Figure 2 Torso Unit


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Sensor units should be connected according to the symbols, as shown in Figure 3.

Cables and connectors are also carry colour indicators.

Figure 3. Connection symbols.

5.2 Catheter Unit (EL-0030/31/32/33)

The catheter is delivered disinfected and in a protective packaging.

The catheter contains two pressure sensors and two temperature

sensors.

Figure 4 Box for Catheter Unit Electronics


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Table 1 Catheter sensors

Sensor Location Function

POES Oesophagus Measures lung pressure

PPH Pharynx Measures pressure in the pharynx

T0 Pharynx Measures temperature variation as a function of respiratory flow.

T1 Nasal cavity Measures temperature variation as a function of respiratory flow.

The electronic circuit that is part of the catheter contains a microprocessor with internal flash memoryxiv

The catheter can only be used a number of times set in the unit itself. It counts the number of qualified

starts. A qualified start is when the catheter has been running continuously for more than 60 minutes

since start-up. Only a certain number of qualified starts is allowed. After that, static values are output

for all parameters and the catheter cannot be used for measurements.

Note that for setup and functional verification, one has to disconnect the catheter before 60 minutes

have elapsed in order to reset the internal minute counter. This can be done an unlimited number of

times.

Catheters used by different patients must be disinfected between uses. The electronic part has therefore been potted so that the entire unit can be submerged in cleaning liquid.

5.3 Neck Unit (EL-0021)

The Neck Unit contains a microphone for detection of airborne sound in 4 frequency bands (160 Hz, 400

Hz and 1 kHz and 2.5 kHz centre frequencies) and it is sampled 8 times per second.

Figure 5 Frequency bands for airborne sound. The bands 160 Hz, 400 Hz, 1000 Hz and 2500 Hz are used. (Courtesy of Mixed Signal Integration Corp.)


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Figure 7 Frequency response of the microphone INMP401 (Courtesy of Analog devices)

The unit also contains a body contact microphone CM-01 that measures

tissue vibration between 8 Hz and 100 Hz and the sampling rate is 256 Hz. An

average of 64 rectified values are transmitted at a rate of

4 Hz.

Figure 8 Typical frequency response of contact microphone CM-01 (Courtesy of Measurement Specialties)

Note that the output of the CM-01 is low pass filtered with an 8th-order elliptic switched-capacitor filter

with cut-off frequency 100 Hz.

Also note that the signal depends very much on the pressure applied when fixing the microphone to the

skin. Signals from two different recordings – even on the same patient – can therefore not be compared

quantitatively.

Figure 6 Enclosure for Neck Unit electronics


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5.4 Wrist Unit (EL-0020)

The Wrist units contains an interface to an SpO2 finger

sensor and SpO2 data and pulse rate along with

sensor status data are requested by the Torso Unit 8

times per second. Each SpO2 value represents a 2-

pulse average in order to detect rapid drops in the

saturation level.

The Wrist Unit also contain a 3-axis accelerometer that

outputs a 14 bit actimeter that is sampled at 50 Hz.

The range is ± 4 g with 0.5 mg per count. Data are

band high filtered at 0.25 Hz, the resultant

acceleration vector found and low pas filtered at 8 Hz.

5.5 Battery (EL-0002)

The battery status is read at 1 minute intervals. This includes remaining battery voltage, remaining

capacity (mAh), full charge capacity (mAh), run-time to empty (min), and temperature (°C). The full

charge capacity indicates the state of the battery and when it should be replaced. Ref configuration of

device below.

5.6 Battery Charger (EL-0017)

A battery charger (EL-0017) is supplied with the system. This is a charger for ApneaGraph® Spiro

batteries EL-0002. Do not use with another type of battery.

Figure 9 Enclosure for Wrist Unit electronics.


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6 Functional Description

The system should be installed and operated by trained personnel – qualified nurses or doctors or

specially trained technicians. The system is typically mounted on the patient at the end of the working

day and data acquisition starts automatically at a pre-set time that suits the patient. The patient sleeps

at home or at a clinic. Data acquisition goes on for 6-8 hours and data are saved in the Torso Unit. The

following day, the doctor, nurse or technician downloads the data to a PC and analysis is carried out.

We have two different scenarios; recording in a clinic where online monitoring may be done in a central

control room or recording at the home of the patient (ambulatory).

a. Assemble parts.

b. Select single use straps for fastening.

c. Insert a charged battery in the Torso Unit. Close the unit using the screw and a Phillips type

screwdriver.

d. Set up the Torso Unit for measurement using a Bluetooth BLE enabled device (mobile phone or

tablet) and the ApneaGraph® Spiro Clinical Setup Software running on an Android device. The

software will synchronize the Torso Real Time Clock to the PC clock.

e. Strap the Torso unit to the chest of the patient. Only one orientation is possible.

f. Fix the Neck Unit to the neck with an op-site® or a similar device, place it in the in the neck strap

pocket and connect the cable to the Torso Unit.

g. Strap the Wrist Unit to the wrist, mount the finger sensor and connect it to the Wrist Unit.

Connect the Wrist Unit to the Torso Unit.

h. Insert the Catheter through one of the nostrils and adjust the height so that the white/blue limit

is behind the uvula at the level of the soft palate.

i. Secure the Catheter to the skin using medical adhesive tape.

j. Verify system functionality using an Android BLE enabled device (PC, tablet or mobile phone). A

non-medical device can be used, but must then be kept outside the patient environment.

k. Patient leaves.

l. Data acquisition starts at a predetermined time and goes on for a predetermined number of

hours. The Torso Unit transmits status data via the BLE radio link. A BLE compatible device with

the corresponding software (or “app”) will receive the data. This is a future option. After 5

minutes of data acquisition, the lights are turned off when the patient lies down. After

acquisition has terminated, the green light is on.

m. Patient returns to clinic.

n. Remove the Torso Unit and all sensor units.

o. Connect the Torso unit to a PC via a USB cable and downloaded the data.

p. Analyse data and save to disk according to hospital procedures.

q. The doctor approves the analysis – alternatively he or she can buy a “support ticket” from Spiro

Medical and request advice. Data should then be submitted along with other relevant

information that the doctor finds meaningful (as attachments).

r. Issue and file diagnosis report according to hospital procedures.


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6.1 Battery Insertion

Figure 10 Battery insertion.

Open the Torso Unit using a screwdriver and insert the battery gently. The battery bay is constructed so

there is only one way to insert it, elimination the danger for wrong polarity.

6.2 Installation of Torso Unit

Place the neck strap around the patient’s neck, and connect it to the Torso Unit with the connectors.

Figure 11 Installation of Torso Unit


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Put the waist strap through the strap-holder on the bottom of the ApneaGraph® around the patient’s

waist, and through the other strap-holder. Ensure that the ApneaGraph® sits tight but comfortably for

the patient.

6.3 Installation of Wrist Unit

• Put the wristband on the patients arm, and connect the SpO2 sensor to the wrist unit.

• Secure the Wrist Unit using adhesive elastic bandage available from Spiro Medical, and connect

the Wrist Unit to the Torso Unit. The cord from the Wrist Unit to the Torso Unit should be

secured with medical tape.

• Make sure the sensor cable is suitably stretched. If it is too loose, the sensor may lose the signal

intermittently.

• Make sure that the cable cannot cause patient entanglement or strangulation.

6.3.1 SpO2 Sensor Mounting

The Sensor is for use on an adult fingertip. Select the most appropriate finger for the sensor size.

Gently open the sensor and guide it over the fingertip, with the sensor cable on top of the finger and

hand. The fingertip should touch the end of the wide section of the sensor. You may need to trim the

patient’s fingernail to position the sensor correctly.

6.4 Installation of Neck Unit

Place a piece of OPSITE® FLEXIFIX (Smith & Nephew) over the microphone, approximately 5 cm x 5 cm,

in order to cover and hold the unit in place.


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Figure 12 Installation of contact microphone and Neck Unit

Connect the cable from the Neck Unit to the Torso Unit.


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6.5 Installation of Catheter Unit

6.5.1 Insertion of Catheter

Figure 13 Insertion of catheter

6.5.1.1 Recommended Equipment for Catheter insertion

Nose speculum, tongue spatula, cleaning tissue, tape, Xylocain gel or spray, a light source, glass of water and a straw.

6.5.1.2 Catheter Insertion

Inform the patient about the study and the process of inserting the catheter.

Inform the patient that eating and drinking light foods is acceptable. No smoking.

Inspect the catheter for damages and make sure there are no sharp edges.

Introduce a local anaesthetic. Use 5 – 10 ml of 2% Xylocain gel or Xylocain spray if preferred. The spray

can however cause coughing, and will then delay the insertion procedure. Local anaesthesia is

beneficial in two ways as it smoothens the pharyngeal surface and makes it less irritated when

introducing the catheter. This effect lasts for a few hours, and allows the patient to get used to the

catheter without coughing or the feeling of having a foreign body introduced. With the patient sitting in


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an examination chair, slightly leaned backwardly, the Gel is inserted through the most open nasal cavity.

From there it freely trickles posteriorly and inferiorly into the pharyngeal region. The patient holds this

position for 10 – 15 minutes, before the procedure is continued. The spray is applied in the nasal cavity

planned for insertion of catheter, and in the oro- and hypo- pharynx.

The insertion of the catheter is then performed through the anesthetised nasal cavity. Start by giving

the patient a glass of water with an angled drinking straw, and ask him or her to hold it in their left hand

(if right handed) and steer the tip with the other. Open the nostril with a speculum while introducing

the catheter tip carefully into the nasal cavity, then gently move it posteriorly and inferiorly until the

patient informs about slight foreign body irritation in the throat. The patient is then told to take a good

mouthful of water, and while swallowing this and continue drinking, the catheter is moved, very gently

and carefully inferiorly. It is extremely important to realise that this is merely a thin membrane covered

thread (Techno Thread) than a stiff and solid catheter. When expected position of the marker, inferior

to the rim of the soft palate is reached, the insertion movement stops.

Correct catheter position is when the marker is at the rim of the soft palate. With a headlight on, and a

tongue spatula in one hand, the patient is asked to open the mouth. By gently pressing the tongue, the

posterior oro-pharyngeal region with the soft palate and catheter can be visualised. While inspecting,

the catheter is retracted until correct position is obtained. It is then fixed externally with tape.

Fix the catheter to the nostril and connect the cable to the Torso Unit.

6.6 Device Configuration

The device is configured while the device and PC are connected via the Bluetooth® Low Energy link.

Most new Android devices (2014 and later) have this feature (contact Spiro Medical for details about

supported devices).

The ApneaGraph® Spiro Clinical Setup Android App can be obtained from Spiro Medical. Contact Spiro

Medical for details.

Make sure that the patient is capable of removing ApneaGraph® equipment including straps without risk of strangulation or entanglement. If not, he or she is not suited for use of the equipment.

Run the Android ApneaGraph® Clinical Spiro Setup App. Note that the pressure amplitudes shown on

the graphs for the catheter are only indicative and do not show calibrated data as every catheter has a

different calibration. To read calibrated pressure data, use the ApneaGraph® Spiro Analysis software.


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Connect to ApneaGraph® Spiro

Start acquisition

Verify battery That Full Capacity is > 2000 mAh and Remaining Capacity is >1000 mAh

Verify that all sensors react properly

Catheter Pressures and temperatures reacts to respiration

Air microphone Reacts to airborne sound

Contact microphone Reacts to “snoring sounds”

Pulse oximeter Reads SpO2 (%) and pulse rate

Actimeter Reacts to wrist motion (in 10 second intervals)

Body position Reacts to changes in upper body tilt (deviation from vertical)

Cannula Reacts to respiration

Respiration belts Reacts to respiration

Ensure that time error is < 1 second. If not, set time.

Set recording start time Select the hour and minutes

Set event from App

In case catheter is used, let the patient close mouth and nostrils and apply some positive pressure for 10

seconds or more.

Set event from app again

Disconnect

Close the App

In case there are problems connecting, close the App, turn off Bluetooth on the mobile device or tablet.

Wait 5 second and turn on again. Start the App again and start over.

On completion of this procedure, the equipment is ready to start up at the set wakeup time and

recording will be done.

After the full night recording, the patient should return to the clinic for removal of the equipment. Data

can then be downloaded to a Windows PC.


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6.7 Indicator Lights

Table 2 shows the indicator lights.

Some may find the lights too bright at night, therefore the lights are turned completely off when the

Torso unit is 30 degrees from horizontal if data acquisition has been on for more than 5 minutes. That

means that lights are off when the patient goes to bed. If data acquisition starts after bedtime, it will be

on for maximum 5 minutes. When data acquisition is complete, the green light will be steady on.

Table 2 Description of indicator lights

Lamp Meaning To do

Green

Slow blinking

Normal operation in wait mode, no activity

Rapid blinking

Data acquisition is ongoing

Steady on Data acquisition is complete

Blue

2 blinks Bluetooth is connected

3 blinks USB is connected

Yellow

2 blinks Clock has not been set (not synchronized)

Connect setup app and set the clock

3 blinks Catheter limit exceeded

Change catheter

5 blinks Error on SD card Replace SD card

6 blinks A damaged sensor Connect setup app and check sensors. Replace the damaged sensor

7 blinks Wrong battery Change battery to a Spiro Medical battery type EL-0002


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6.8 Data download

Unscrew the bottom cover of the Torso unit using a suitable screwdriver and connect it from the micro

USB connector to one of the USB ports on a PC.

Figure 14 Connecting the USB

Open the file explorer. The Torso SD card will appear as a removable disk with one folder per recording.

Folders are numbered with the latest recording having the highest number.

Follow the instruction in the software manual regarding data download and analysis.

6.9 Change of SD Card

In case the SD card must be replaced, gently press the SD card which is located above the USB

connector. It will then pop out ad can easily be removed. Insert an SD card by pushing it gently into slot.

Make sure it has been formatted with FAT32 file format.


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7 Maintenance and Storage

7.1 Environmental Conditions

The devices can be stored, transported and operated under the following conditions:

Table 3 Environmental conditions.

Device Storage and transportation Operating

All units except catheter tube -20°C without relative humidity control to 60°C at a relative humidity up to 93%, non-

condensing

15% to 93% (non-condensing)

+5°C to +40°C

Catheter tube 60 cm -20°C without relative humidity control to 60°C at a relative humidity up to 93%, non-

condensing

Can be submerged in water

+30°C to +40°C

During operation, the atmospheric pressure range can be from 800 hPa to 1 060 hPa. 800 hPa is the

normal barometric pressure at 2000 m altitude.

Note that the lowest 60 cm of the catheter tube is for insertion through nostrils and down to the

oesophagus.

7.2 Battery Charging

The battery must be removed from the Torso Unit to be charged. This must be done using a separate charger supplied by Spiro Medical.

7.3 Calibration

All sensors are pre-calibrated and no calibration is required by the operator, other than a functional

verification and a simple check that all the sensors are functional.

7.4 Cleaning and Disinfection

Wipe off torso unit, neck unit and wrist unit with a soft cloth with a mild detergent solution.

7.4.1 Catheter

NOTE THAT THE APNEAGRAPH® CATHETER CANNOT BE AUTOCLAVED.

The reusable catheter electronics is completely potted, and can hence be completely submerged in

cleaning liquid, including the cable connector. It is delivered clean, but we recommend disinfection

before use and between uses. See section 7.4.1


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7.4.1.1 Cleaning procedure: Wet disinfection

Rinse the catheter carefully under tap water at 30 °C (86 °F) +/- 5°C.

Use a soft cloth to wipe off any debris and mucus. Do not touch the sensor points with your fingers.

Disinfect with approved medical cleaning agent.

The catheter can be disinfected with one of the following liquids:

• Virkon® (by DuPond),

• Perasafe® (by DuPond),

• Stabimed® fresh (by B. Braun) using 0.5% solution.

It can also be cleaned with Sekusept® Multienzyme (by Ecolab).

Note that the catheter is certified for use with the above liquids and only those.

Follow the manufactures instructions (for Stabimed® fresh, use 0.5% solution) for use on all cleaning

fluids including rinsing the catheter after disinfection.

Store according to hospital procedures for disinfected equipment.

7.4.2 SpO2 Sensors

Unplug the sensor before cleaning or disinfection. Single use sensors do not require cleaning. The below

procedure refers to reusable sensors.

1. Dip clean the sensor part (not the connector) in a mild detergent solution or a 70% isopropyl

alcohol solution. If low-level disinfection is required, use a 1:10 bleach solution.

2. Rinse the sensor part (not the connector) in water, wipe with a dry cloth and leave to dry

completely.

7.5 Battery Storage

The CC2300 is capable of being stored and transported over a temperature range of -20°C to +60°C. Users should avoid storing the batteries for prolonged periods towards the high end of this range, as it will permanently degrade the life of the battery. Batteries should ideally be stored in a partially charged state (40-60%) and in an environment with low humidity free from corrosive gas within a temperature range of -20°C to +20°C. Batteries are shipped from Spiro Medical with ~50% residual capacity. If the batteries are stored at a

temperature higher or if the storage period exceeds 12 months then the residual capacity may be

depleted and the internal protection electronics will enter a hibernate mode to protect the internal cells

from damage caused by over discharge. Charging the battery will automatically re-wake the battery.


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7.6 Service

When qualified service personnel at a qualified service site are available, MANUFACTURER will, upon

request, provide circuit diagrams, component part lists, descriptions, calibration instructions, or other

information to assist SERVICE PERSONNEL to repair parts where this is possible.

7.7 Service and Shelf Life

Table 4 Service and shelf life of parts and components.

Part Description Expected service life Shelf life

EL-0019 Torso Unit 7 years Same as service life

EL-0030 Reusable catheter 16 to 50 full night recordings

2 years


2 years


2 years

EL-0033 Single use catheter 1 full night recording 2 years

EL-0021 Neck Unit 7 years Same as service life

EL-0020 Wrist Unit 7 years Same as service life

EL-0002 Battery 2 years depending on use

Same as service life

EL-0017 Battery charger 7 years Same as service life

8 Compatible Sensors and Devices

Components that are part of the APNEAGRAPH® SPIRO device are all unique to the APNEAGRAPH®

SPIRO. They all have connectors that are unique to the system.

The SpO2 sensor has a unique plug that fits the Wrist Unit and the cable length is 20 cm. The following

sensors are supported:

• Metko RAS reusable SpO2 Sensor

• Metko RAS (B) reusable SpO2 Sensor

• Metko Disposable SpO2 Sensor ApneaGraph Spiro

The catheter is unique and the only one compatible with the Torso Unit.

Note that the catheter electronics contain logic that counts the number of full night recordings. If the

above limits are reached, the catheter is outside specified limits and can no longer be used.

The Torso Battery is a unique battery approved for medical use. It has a unique digital key in order to

ensure that proper batteries with the required size, capacity and medical certifications are used.

The Torso SD card as delivered with the unit has been tested and approved by Spiro Medical and should

not be replaced without consulting Spiro Medical AS.


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9 Training

Spiro Medical offers training to medical professionals on the use and application of the ApneaGraph®

Spiro.

A. Diploma course over 2 days. Upon successful completion, the participant will receive a diploma

from Spiro Medical.

B. Web-based based introductory course for medical professionals.

Contact Spiro Medical AS for more information.

10 Specifications

10.1 Torso Unit

Table 5 Torso Unit specifications.

Sensors Body Position x, y, z acceleration

Connections

Cannula/Catheter Neck Unit Wrist Unit Respiration Belts

Maximum number of connector matings

1000 Replace connectors in the Torso unit if above this limit (i.e. send in for service).

Interfaces BLE, USB

Bluetooth low energy (BLE) for setup and status data output. USB for data download to PC. The connector is micro USB.

SD card 16 GB San Disk SDSDQAB-016G.

Clock retention when battery has been removed

More than 96 hours


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10.2 Catheter Unit

Table 6 Catheter Unit specifications.

Sensors

POES Pressure sensor Location: 50 mm from tip

PPH Pressure sensor Location: 248 mm from tip

T0 Temperature sensor Location: 248 mm from tip

T1 Temperature sensor Location: 298 m from tip

Catheter diameter ~1.3 mm ~2.0 mm at pressure sensor locations

Pressure

Calibrated range -300 cmH2O to +300 cmH2O

Measurement range

-600 cmH2O to +600 cmH2O

Compensated range1

30°C to 38°C

Burst pressure2 4000 cmH2O (4 Bar)

Linearity 0.1% of span

Resolution 0.1 cmH2O

Dynamic accuracy

± 1.0 cmH2O

Temperature

Range 30°C to 38°C

Linearity 0.5% of span

Resolution 0.15°C

Dynamic accuracy

± 1.0°C

Sampling rate 4 Hz

Output data Instantaneous values

Limits on use 20 starts Limited by the number of qualified starts3.

Calibration The catheter is factory calibrated, no in-service calibration is necessary

1 The temperature range where the specification is valid. In this temperature range, the temperature drift of the pressure sensors is compensated. 2 The maximum pressure, which may be applied without causing damage to the sensor. 3 A qualified start is when the catheter has been running continuously for more than 60 minutes since start-up


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10.3 Body Position

Table 7 Body Position sensor specifications.

Measurement 3 axis acceleration

Resolution 14 bit

Sensitivity 2048 counts per g

Sampling rate 1 Hz

Bandwidth 0 Hz to 1 Hz

Output data x, y, z

Calibration The accelerometer is factory calibrated, no in-service calibration is necessary


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10.4 Oximeter

Table 8 Oximeter specifications.

%SpO2

Range 0-99%

Resolution 1%

Accuracy ± 2 Arms @ 70-100% SpO2. Less than 70% is undefined

Averaging 2 pulses

Pulse Rate

Range 30-254 BPM

Resolution 1 BPM

Accuracy Arms = ± 1

Averaging 8 pulses

Sampling rate 1 Hz

Calibration Factory calibrated over range 70% to 100% using human blood samples to functional saturation. No in-service calibration is necessary.

Flags

No finger in sensor Flag4 set when the Wrist Unit does not detect a finger in the sensor

Sensor unplugged Flag set when the Wrist Unit does not detect a sensor connected to it

Searching for Pulse Flag set when the Wrist Unit is in the process of locating a valid pulse

Searching too long Flag set after no valid pulse and now greater than 20 seconds of searching for a valid pulse

Lost pulse Flag set after at least one valid pulse and now greater than 20 seconds of searching for a valid pulse

4 A «flag» is a warning saved with the recording.


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10.5 Actimeter

Table 9 Actimeter specifications.

Measurement 3 axis acceleration combined into one resulting acceleration vector

Resolution 14 bit

Sensitivity

14 bit

2048 counts per g

0.5 mg per count

Raw sampling rate 50 Hz

Epoch length 10 seconds

Bandwidth 0.25 Hz to 8 Hz

Output data Average of acceleration vector over the epoch

Calibration The accelerometer is factory calibrated, no in-service calibration is necessary

10.6 Contact Microphone

Table 10 Contact Microphone specifications.

Measurement Senses tissue vibration

Sensitivity Virtually zero sensitivity to air-borne acoustic noise. Sensitivity to vibration: 40 V/mm

Internal sampling rate 256 Hz

Bandwidth 8 Hz to 100 Hz

Averaging Average of 64 rectified values

Data transmission rate 4 Hz

Calibration The microphone is factory calibrated, no calibration in the field is necessary


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10.7 Airborne Sound Microphone

Table 11 Airborne sound microphone specifications.

Measurement Measures airborne sound pressure level

Directionality Microphone is omnidirectional, but directionality is affected by enclosure

Sensitivity -42 dBV

Microphone Bandwidth 100 Hz to 15 kHz

Filtered frequency bands 160 Hz, 400 Hz, 1 kHz, 2.5 kHz

Output Peak in each band over 125 ms

Output rate 4 Hz

Calibration The sensor is factory calibrated, no in-service calibration is necessary

10.8 Battery

Table 12 Battery Cell Level Specification

Technology Rechargeable Lithium Ion

Manufacturer Accutronics

Manufacturer Model Number EL-0002 ICP523450D2

UL File Number BBCV2.MH19896

IEC File Number QAE-EF03-090817-PR523450D2

Table 13 Battery Level Specification.

Technology / Configuration Lithium Ion / 1S2P

Nominal Voltage 3.7V Average voltage during a 0.2C discharge at +20°C

Nominal Capacity 2300mAh Based on 4.2V 0.5C charge at +20°C, followed by a 0.2C discharge to 3.0V at +20°C.

Minimum Capacity 2185 mAh


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Charge Temperature Range 0°C to +45°C Battery ambient temperature

Charger EL-0017 Battery charger for battery EL-0002

Maximum Charge Current 2000 mA

Discharge Temp Range -10°C to +60°C

Maximum Discharge Current 2000 mA

Storage Temperatures 12 months: -20°C to +20°C

These are recommended storage temperatures. See section 3.5

3 months: -20°C to +45°C

1 month: -20°C to +60°C

10.9 Bluetooth® Radio Link

Table 14 Bluetooth specifications.

Bluetooth

Version 4.0 (Bluetooth Smart)

Security Secure Simple Pairing and AES-128

BR/EDR connections 0

LE connections up to 8

Table 15 Bluetooth radio specifications.

Radio

Frequency 2.402GHz to 2480GHz

Modulations GFSK

Transmit power + 0 dBm

Receiver sensitivity - 93 dBm

Typical line-of-sight range 30 - 100 meters

Antenna Integrated ceramic chip

Radiation level < 12 dBm

10.10 Regulatory Information

Degree of protection (applied part) against electric shock: The device is classified as of type BF applied

part, risk class IIa.

Electrical rating maximum 3.7 VDC from internal Li-ion battery (internally powered equipment).

Installation/use of the device: The device is classified as a transit-operable and body worn (by the

patient). In the clinic or the hospital, it is classified as non-transit-operable and hand-held.

Pollution degree: 2


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10.10.1 Product Labels

The equipment carries labels as described below.

Table 16 Product labels

Part Description Label

EL-0019 Torso Unit5

EL-0030 EL-0031 EL-0032 EL-0033

Catheter

EL-0021 Neck Unit

EL-0020 Wrist Unit

5 Note that serial numbers and lot numbers are examples only.


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Part Description Label

EL-0018 Cannula Unit

The symbols are explained below.


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Table 17 Explanation of label symbols

Symbol Explanation

Serial number.

Legal representative in the EC.

Batch or lot number.

CE label with number of the notified body (DNV GL Nemko PreSafe AS, Norway. NB 2460)

Manufacturer.

Manufacturing date (Year-month).

Information on the Bluetooth radio.

Refer to instruction manual.

Emits non-ionizing radiation.

To be sold to a physician.

Not for general waste.

Keep dry.

Type BF applied part.

Single (patient) use only.

Temperature limitation. Upper and lower storage temperature limits are shown on either side of the symbol. This label is on packaging only.

The product is not sterile. This label is on catheter packaging.


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Do not use if packaging is broken. This label is on catheter packaging.

10.11 EMC Compliance

This equipment is intended for use in the electromagnetic environment specified below. The customer

or the user of the equipment should assure that it is used in such an environment.

Electromagnetic emissions:

Table 18 Electromagnetic emission compliance.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Group 2 Class B

The device must emit electromagnetic energy in order to perform its intended functional. Nearby electronic

equipment may be affected.

Electromagnetic immunity (home healthcare environment):

Table 19 Electromagnetic immunity levels.

Immunity test IEC 60601 test level

Compliance level

Electrostatic discharge (ESD) IEC 61000-4-2

± 8 kV contact ± 2/4/8/15 kV air

± 8 kV contact ± 2/4/8/15 kV air

Radiated RF EM fields IEC 61000-4-3

10 V/m 80 MHz to 2,7 GHz

10 V/m 80 MHz to 2,7 GHz

Proximity fields from RF wireless communications equipment

IEC 61000-4-3 See Table 20 See Table 20

Conducted disturbances induced by RF fields

IEC 61000-4-6

3 V 0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands between 0,15 and 80

MHz

3 V 0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands between 0,15 and 80

MHz


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Table 20 Tested frequency bands for immunity to RF wireless communications equipment.

Test frequency

(MHz)

Band (MHz)

Service Modulation Maximum

power (W)

Distance (m)

Immunity test level

385 380-390 TETRA 400 Pulse modulation

18 Hz 1.8 0.3 27

450 430-470 GMRS 460

FRS 460

FM ± 5 kHz deviation

1 kHz sine 2 0.3 28

710, 745, 780

704-787 LTE Band 13, 17 Pulse modulation

217 Hz 0.2 0.3 9

810, 870, 930

800-960

GSM 800/900 TETRA 800 iDEN 820

CDMA 850 LTE Band 5

Pulse modulation 18 Hz 0.2 0.3 28

1720, 1845, 1970

1700-1900

GSM 1800 CDMA 1900 GSM 1900

DECT LTE Band 1,3,4,25

UMTS

Pulse modulation 217 Hz 2 0.3 28

2450 2400-2570

Bluetooth WLAN 802.11 b/g/n

TFID 2450 LTE Band 7

Pulse modulation 217 Hz

2 0.3 28

5240, 5500, 5785

5100-5800

WLAN 802.11 a/n Pulse modulation 217 Hz 0.2 0.3 9


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10.12 Standards

The ApneaGraph® Spiro conforms to:

• ANSI/AAMI ES60601-1:2005/A1:2012 Issued: 2012/08/20 Medical electrical equipment – Part 1:

General requirements for basic safety and essential performance, Amendment 1.

• IEC 60601-1-6 Issued: 2013/10/29 Ed: 3.1 Medical Electrical Equipment – Part 1-6: General

Requirement for Basic Safety and Essential Performance – Collateral Standard: Usability.

• IEC 62366 Issued: 2014/01/28 Ed. 1.1 Medical devices – Application of Usability Engineering to

Medical devices.

• ANSI/AAMI HA60601-1-11: 2011 Issued: 2011/11/11 Medical electrical equipment – Part 1.11:

General Requirement for Basic Safety and Essential Performance – Collateral standard:

Requirements for medical electrical equipment and medical electrical systems used in the home

healthcare environment.

10.13 Performance Testing and Validation Summary

The APNEAGRAPH® SPIRO system has been tested and verified in various phases to include internal

testing, verification and validation as well as external testing to assure product safety, effectiveness and

reliability. The design was verified and validated, including clinical evaluation, throughout the design

process, according to requirement specifications and intended use. An external accredited test house

was used to conduct testing needed to comply with the applicable standards regarding EMC and patient

safety.


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11 Trouble Shooting

Below is a list of possible problems related to the use of the equipment.

Symptom Possible cause Solution

Low battery. The Clinical Setup App shows battery capacity < 1000 mAh, but full capacity is > 2000 mAh.

Battery not charged fully.

Charge battery.

Low battery. The Clinical Setup App shows full capacity is < 2000 mAh.

Battery too old. Buy a new battery and dispose of the old battery according to local environmental regulations.

Cannot connect Bluetooth from Android app to Torso device.

Android device (tablet or phone) is not Bluetooth 4.0 (includes Bluetooth Low energy) compliant.

Change Android device.

Bluetooth error on Android device (will not connect)

Go to “settings” and turn off Bluetooth, wait 10 seconds and turn on again.

Bluetooth error (will not connect even if above has been tried)

Remove battery on Torso unit, wait 10 seconds and insert again. This is Torso reset. Go to “settings” and turn off Bluetooth, wait 10 seconds and turn on again. This is Bluetooth reset. It is important to do both reset operation.

Will not connect to Torso via USB. PC says “Unknown device” and/or Torso unit resets (all 3 lights blinks at the same time).

Faulty USB cable.

Change USB cable.

If no other cable is available, remove SD card from Torso unit and insert in PC (depending on the type of PC, an adapter may be required)

Cannot insert USB cable in Torso.

Micro USB connector too thick.

Change USB cable to one which is supplied by Spiro Medical.

If no other cable is available, remove SD card from Torso unit and insert in PC (depending on the type of PC, an adapter may be required)


41

Torso resets (all LEDs blink repeatedly)

Corrupt file system on SD card.

Replace the SD card or fix the file system. The file system can be fixed if the Torso can be connected via USB or the card can be inserted in a compatible PC slot. Use the file browser of the Windows PC to find the drive letter of the SD card (for example D:). Run cmd.exe (for example via Windows search, type “cmd”). From the command line window (cmd.exe) type chkdsk D: /F This will scan the card and attempt to fix the file system (due to the /F option). Retry the Torso unit, if it is still to working, try to replace the SD card.

i Use of a product in accordance with the specifications, instructions and information provided by the manufacturer. ii Operation in normal use for an unlimited period without the specified limits of temperature being exceeded. iii Sleep Related Breathing Disorders. iv Respiratory Disturbance Index or Respiratory Distress Index. v Apnea Hypopnea Index. vi Obstructive Sleep Apnea Syndrome. vii Respiratory Effort Related Arousals. viii Performance necessary to achieve freedom from unacceptable risk. ix Capacitor for storage of electrical energy. Used instead of battery. x Light emitting diodes. xi Universal Serial Bus. xii Bluetooth Low Energy Link according to the Bluetooth standard 4.0. xiii Personal computer, laptop, pad or smart phone. xiv Computer memory that is not lost when power is removed.

Documents

ApneaGraph Spiro User Manual without ETL