Bitmed SLEEP&GO User Manual

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SLEEP&GO

CARDIORESPIRATORY POLYGRAPH

USER’S MANUAL

534-7AB-MU2 • REV. 1.07 • 2014-06

MANUAL

SYSTEM

NFIG.

19/06/10

75% 11:15

Please refer to the device’s Service Manual for additional information.

This manual can be purchased through the After Sales Service.

SIBEL S.A.

Rosselló 500, 08026 Barcelona - Spain National Sales: Tel. 93 436 00 08 e-mail: comercial@sibelmed.com International Sales: Tel. +34 93 436 00 07 E-mail: export@sibelmed.com Technical service: Tel. +34 93 433 54 50 E-mail: sat@sibelmed.com Fax: +34 93 436 16 11, Website: www.sibelmed.com SIBEL, S.A. belongs to SIBELGROUP

No part of this publication may be reproduced, transmitted, transcribed, stored in a back-up system or translated into any language or computer language in any form or by any means, electronic, mechanical, optical, chemical or manual without the express written consent from SIBEL S.A.

DISCLAIMER

SIBEL S.A. is responsible for the security, reliability and performance of this equipment only if:

• The place where the systrem is installed or used meets the requirements for

electrical installations IEC and other applicable regulations.

• All repairs, revisions or modications, both in and out of the warranty period, are

made by technical staff of Meditel Ingeniería Médica S.L. o SIBEL S.A.

• The system is used by qualied staff in accordance with the recommendations

stated in this User’s Manual.

BRANDS

Bitmed is a registered trademark of Sibel, S.A.

534-7AB-MU2 • REV. 1.07

PRODUCT IN COMPLIANCE WITH MEDICAL DEVICE DIRECTIVE

93/42/EEC (CLASS IIa).

Thank you for choosing this product. SLEEP&GO system is designed and

manufactured with the best guarantees of quality.

Applications SLEEP&GO and its related software will open a world of

possibilities in the sleep study.

If you have any possible improvement for this product, we welcome your

suggestions may be directed to Customer Service Department.

Revised Approved Date: 2014-06 Date: 2014-06

Technical Director Sales Director

534-7AB-MU2 • REV. 1.07

0197

Index

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User’s Manual

534-7AB-MU2 • REV. 1.07

TABLE OF CONTENTS

SAFETY ..............................................................................7

INTENDED USE ..................................................................7

INDICATIONS FOR USE .....................................................8

LIMITATIONS IN USE. CONTRAINDICATION .....................9

WARNING AND PRECAUTIONS ..........................................9

DISPOSAL OF ELECTRICAL AND ELECTRONIC DEVICES BY

DOMESTIC USERS IN THE EUROPEAN UNION .......13

1 INSTRUCTIONS OF INSTALLATION AND USE ...............15

1.1 MODELS ....................................................................15

1.2 PACKING LIST ...........................................................16

1.3 LAYOUT OF CONTROLS, INDICATORS AND

CONNECTORS ..................................................................20

1.3.1 FRONT/TOP/RIGHT PANNEL ..................................20

1.3.2 LEFT PANNEL .......................................................... 20

1.3.3 REAR PANNEL .........................................................21

1.4 INSTALLATION AND START-UP ..................................21

1.4.1 BATTERY PLACEMENT ............................................21

1.4.2 POWER SAVING MODE ............................................22

1.4.3 BLUETOOTH MODULE INSTALLATION .....................22

1.4.4 PLACEMENT OF SENSORS AND ELECTRODES ...........22

1.4.4.1 PLACEMENT OF THE SLEEP&GO POLYGRAPH .......22

1.4.4.2 NASAL CANNULA .................................................23

1.4.4.3 THERMOCOUPLE AIRFLOW SENSOR ..................... 24

1.4.4.4 THORACIC AND ABDOMINAL EFFORT BANDS .......25

1.4.4.5 PULSE OXIMETER ................................................26

1.4.4.6 BODY POSITION AND ACTIVITY ..........................29

1.4.4.7 SNORING SENSOR ...............................................29

1.4.4.8 LIMB MOVEMENT SENSOR ...................................30

1.4.4.9 EKG ELECTRODES ................................................30

1.4.4.10 EMG. EOG AND EEG ELECTRODES .......................31

1.4.4.11 EVENT MARKER ..................................................33

2. OPERATION ................................................................. 34

2.1 WORKING MODES ...................................................... 34

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Index

534-7AB-MU2 • REV. 1.07

2.2 SYSTEM CONFIGURATION .........................................35

2.3 INITIAL DEVICE SETUP .............................................36

2.3.1 SETTING THE DATE AND TIME ................................ 36

2.3.2 SETTING THE LANGUAGE ........................................ 36

2.3.3 SETTING THE TYPE OF BATTERIES ..........................37

2.3.4 SETTING THE UNITS OF THE CPAP CHANNEL ..........37

2.4 SWITCHING ON/OFF THE BLUETOOTH MODULE ........37

2.5 MAKING POLYGRAPHY TESTS IN ONLINE MODE ........39

2.6 MAKING POLYGRAPHY TESTS IN HOLTER MODE ........39

2.6.1 STARTING AND ENDING A TEST MANUALLY............39

2.6.2 SCHEDULED TESTS .................................................40

2.6.2.1 SCHEDULING A TEST IN THE SLEEP&GO .............. 40

2.6.2.2 DISPLAYING THE SCHEDULED TESTS ...................42

2.6.2.3 CHANNEL CONFIGURATIONS ...............................43

2.7 TRANSFER AND REVIEW OF THE TESTS .....................43

2.8 FIRMWARE UPDATE ...................................................44

2.9 DEVICE OPTIONS UPDATE ......................................... 44

3. TECHNICAL SPECIFICATIONS ...................................... 46

3.1 GENERAL DATA ..........................................................46

3.2 PULSE OXIMETER TECHNICAL SPECIFICATIONS ........50

3.3 CONDITIONS OF OPERATION AND STORAGE OF

ACCESSORIES ..................................................................51

3.4 APPLICABLE STANDARDS .......................................... 51

4. SYMBOLOGY ................................................................ 55

4.1 SYMBOLOGY OF THE SLEEP&GO ................................. 55

4.2 SYMBOLOGY OF THE ACCESSORIES ........................... 56

4.3 VALIDATED ACCESSORIES ......................................... 58

5. CLEANING AND MAINTENANCE ....................................60

5.1 CLEANING .................................................................60

5.2 PREVENTIVE MAINTENANCE ...................................... 60

5.2.1 ACTIONS TO BE TAKEN BY THE USER ......................60

5.2.2 ACTIONS TO BE TAKEN BY QUALIFIED PERSONNEL 61

5.3 CORRECTIVE MAINTENANCE ......................................62

ANNEX 1. ELECTROMAGNETIC COMPATIBILITY ...............63

ANNEX 2. TROUBLESHOOTING GUIDE ............................. 68

Index

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Declaration of conformity

SAFETY

The Sleep&Go cardiorespiratory polygraph has been developed by the R+D+i Department of SIBEL S.A. with the collaboration of reference Health Centers and doctors specialized in the area of Sleep Disorders. The Sleep&Go cardiorespiratory polygraph is designed and manufactured in accordance with the Quality Manual of SIBEL S.A. which is in consistency with the quality standards EN 13485 and ISO 9001 and European Directive 93/42/EEC concerning medical devices and 2007/47/EC. According to this directive the equipment is Class IIa. The Sleep&Go also complies with the EN 60601.1 Electrical Safety and Electromagnetic Compatibility EN 60601.1.2

standards, as specied in the ELECTROMAGNETIC COMPATIBILITY

annex. The Sleep&Go can transmit data via Bluetooth and therefore follows the Directive 1999/5/EC on radio equipment and telecommunications terminal equipment. For other countries complies with FCC rules (parts 15c) and Canada Industry (IC: 5123A-BGTWT11A). The Sleep&Go also complies with the following directives and

regulations: Packaging and packaging waste directive 94/62/

EC; Waste Electrical and Electronic Equipment Directive (WEEE)

2002/96/EC; Regulation EC 1272/2008 on classication, labelling and packaging of substances and mixtures (REACH).

INTENDED USE

Acquisition, storage and display of biomedical signals for the

simplied diagnosis and control of sleep-related breathing disorders

(mainly Sleep Apnea and Hypopnea Syndrome) being anyone or

any combination of the following signals: respiratory airow, snore, CPAP pressure measurement, thoracic effort, abdominal effort,

SpO2, beats per minute, perfusion wave, body position, body activity, extremity limb movement, and EEG-EMG-EKG signals.

Next conditions must be taken into account:

• Use in a health center, patient’s home or similar indoor use (not

for outdoor use).

• Not intended for use in moving transport vehicles.

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• Not intended for monitoring vital signals.

• EKG signal can not be used for heart diagnosis purpose. It’s

only intended for bradycardia and tachycardia detection during sleep analysis.

INDICATIONS FOR USE

The Sleep&Go has been designed for maximum safety. All of the operating instructions should been read before proceeding to operate with the system. Failure to do so may result in injuries to the user or the patient and damage to the device and/or accessories.

The Sleep&Go has been designed for being used by a doctor or a technician trained in the acquisition of cardiorespiratory signals

and the transmission of these signals to a PC during polygraphic tests. The user is allowed to congure the device under these conditions. However, it is not recommended that the conguration

of the device is changed without understanding the principles of signal digitalizing.

Minimum age of patients is 5 years, weighing over 15 kg and

a minimum height of 70 cm. The medical staff will instruct the patient for a correct test execution, to avoid interferences in the measurement and to replace the sensors in case of movement. It is therefore important that the patient can understand the instructions given by medical staff.

The intended environments of use are hospitals, sleep centres and sleep clinics. Tests may also be carried out at the patient’s home, with the exception of ExG signals (EEG, EMG, EOG, EKG). In this case the patient is only authorized to start and stop the test, and should be adequately instructed by the doctor on this respect. The Sleep&Go is not designed to be used outdoors, nor in other conditions or with energy sources not covered in this manual. Using the Sleep&Go systems does not involve any monitoring or diagnosis of the patient.

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LIMITATIONS IN USE. CONTRAINDICATION

The interpretation of the tests and any ensuing treatment must be carried out by a doctor. The acceptability of a test is the responsibility of the health personnel.

The symptoms presented by the patient before starting any test should be considered by the health personnel.

The Sleep&Go should not be used when it is likely that the validity

of the results may be compromised due to external factors (Electro Magnetic interference – see section EMC).

WARNINGS AND PRECAUTIONS

The Sleep&Go IS NOT CERTIFIED FOR USE IN CONTINUOUS MONITORING, where a failure in operation may cause injuries or the death of the patient. This product does not maintain nor does it help to maintain the life of the patient. The term CONTINUOUS

MONITORING is specied in regulation EN60601-1. The Sleep&Go is classied as Class IIa in accordance with Directive 93/42/EEC on

medical devices.

The pulse oximeter is not provided with physiological-type alarms.

The pulse oximeter is calibrated to display functional oxygen saturation and requires no calibration.

The pulse oximeter waveform is not standarized.

The Sleep&Go is not intended for monitoring vital signals.

There are no applicable parts to the patient which produce stimulation.

The system has no user-serviceable parts. Use only authorized service and spare parts supplied by the manufacturer.

Contact of liquids with the internal parts of the device and the connectors must always be avoided.

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The system is only resistant to moderate splashing and dripping

(Protection level IP22: protection against access to hazardous parts with a nger; protected against solid objects with a diameter of

12.5 mm and above; protected against water drops falling vertically with a maximum inclination of 15 degrees of the envelope).

Do not submerge the parts of the device in any liquid. MAY CAUSE

ELECTRIC DISCHARGE.

No parts are allowed for temporary immersion.

The cleaning instructions in this manual and also in the instructions of use of any sensor supplied but not manufactured by SIBEL S.A. must be carefully followed.

Keep your device protected from shock and vibration. During

transportation, place all the items in the carrying case. The material provides enough protection against small accidental impact.

Do not use the system in and MRI environment.

The system is not designed to work in an explosive environment or in the presence of ammable anesthetics or gases of any kind. MAY CAUSE EXPLOSION.

This product is intended for indoor use (e.g. at the patient’s home or hospital) and is not suitable for use during patient transportation.

The polygraph is not intended to be used outdoors or with other conditions or energy sources that are not covered in this manual.

The Sleep&Go is not protected against debrillation shocks. Therefore, never use a debrillator on a patient connected to a

Sleep&Go system.

Do not use an electric scalpel or a high frequency surgical device while the patient is connected to any sensors or electrodes of the Sleep&Go.

The use of mobile phones, transmitters and similar equipment generating radio frequency emissions and placed next to the system is not allowed during the tests. Therefore, do not use the

system in the presence of radio equipment (mobile phones, walkietalkie ...). Follow the recommendations regarding the separation

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distance specied in the manufacturer’s declaration for EMC in this

manual.

Remember that when multiple devices are connected to a patient

there is a risk of accumulation of leakage current. Minimize the

number of devices.

Do not remove the device cover. The service and repair of the device should be carried out only by trained personnel.

The Sleep&Go system is prepared to work at room temperature.

Avoid exposing any part of the system to heat sources. Also avoid direct exposure to sunlight. Temperature changes cause condensation and moisture. Before using the system, allow the device to acclimate to ambient temperature. For reference, if the temperature difference between the system and the environment is above 10º C a 20 minutes wait time in an intermediate temperature is recommended.

The polygraph should not be placed adjacent to or stacked with

other equipment.

The system shall be stored and used within the temperature ranges,

pressure and humidity specied in section number 3.

Artefacts in the signal may be produced as a result of ESD. A trained operator should be able to recognize these artefacts easily.

The operator must be trained to be able to recognize the differences between a biological signal and signal artifacts caused by patient movements, RF interference or poor placement of the electrodes or sensors. The presence of ESD or RF devices will not lead to wrong

conclusions. Unusable data is not considered a risk to the patient

safety.

Cables or sensors should not surround the patient’s neck, especially

when the patient is a child.

The Sleep&Go system does not increase the safety risk for patients with pacemakers in accordance with the EN50061 standard (Medical electrical equipment – Safety of implantable cardiac pacemakers). Before using the system in patients with pacemakers, the operator should check the documents accompanying the pacemaker with respect to its certication and requirements of use and, if necessary,

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contact the manufacturer.

Patients must be insistently warned that they must not open the

Sleep&Go or attempt to adjust it.

Sensors or accessories in bad condition should not be used.

Use only the Sleep&Go with accessories, sensors and electrodes provided by the manufacturer or dealer, or those that meet the

specications of this manual. The use of other sensors with the

Sleep&Go can cause damage to the device or the quality of the signals.

Sensors should be handled by their strongest parts, which are the connectors. Also, they should not get wet or exposed to very abrupt changes of temperature. To clean the sensors, do not use abrasive chemicals. Do not apply excessive stress to the sensors. In particular, avoid bending any part of the sensors. This means that the material should not bend more than necessary in normal use.

The polygraph is designed to be used exclusively by medical staff, who should be supervised and instructed by a physician.

Medical personnel should inform the patient about precautions to

be found in the WARNINGS AND PRECAUTIONS section and to be taken when using the equipment.

Use the provided carrying case when transporting the device and its accessories.

Do not reuse single-use accessories as there is risk of infection to

the patient.

In case of doubt or unexpected event contact the manufacturer. You can nd contact details on page 2 of this manual.

The use of nasal cannulas is not recommended in pregnant women or children, because they contain phtalates.

Do not leave the batteries inside the device if it won’t be used for a long period of time.

Ensure to perform the adquisition of signals in an acustic and light

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environment that allows the patient to sleeping normally.

The system cannot be used for DIRECT CARDIAC APPLICATION.

The system is not an electrocardiograph, and therefore can not be used to generate a separable ELECTROCARDIOGRAM for diagnostic purposes, electrocardiographic monitoring or for ambulatory electrocardiography. The EKG signal is only intended for bradycardia and tachycardia detection during sleep analysis.

As for the electrodes, a proper contact of the skin with the

electrodes must be achieved by using conductive paste. Otherwise,

there is a risk of inaccurate measurements. Avoid contact with

the eyes or mucus membranes of gels, collodion, alcohol, acetone or any substance used in the placement or removal of electrodes. Be especially careful in the usage of collodion. Always follow the recommendations for use provided by your collodion manufacturer.

The conductive part of the electrodes and connectors, including the ground electrode must not touch other conductive parts, including the ground.

DISPOSAL OF ELECTRICAL AND ELECTRONIC DEVICES BY

DOMESTIC USERS IN THE EUROPEAN UNION

Never dispose of the Sleep&Go, its accessories and its batteries in the household trash. It must be disposed of properly and may need to be recycled in accordance with the statutory requirements in your country.

• Materials according to the RoHS Directive 2011/65/UE. Conform from July 22th, 2014. The device uses a lithium battery and could use an optional NiMh battery.

For devices commercialised before July 22th, 2014: The SleepSense sensor for limb movement contain mercury.

All Sleepsense sensors (except the cannulas) contain Pb in the

solderings. All Sleepsense sensors (except the cannulas) may also contain

PBB and PBDE. The cables for electrodes (Ref. 08093) contain Pb in the

soldering.

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The interconnection bridge (Ref: 02741) and the cable adapter (Ref. 01644) contain Cadmium.

• Materials according to the Medical Device Directive: two of the sensors that may be used in combination with the

device, contains phtalates (Sleepsense cannulas and Pro-Tech

cannulas). The device and all the accesories are latex free.

• Materials according to the REACH regulation: neither the device nor its accessories use any hazardous substance according to REACH regulation.

• In the event that the device or its accessories are infected at the time of recycling, it must be disinfected or disposed by following the national regulations regarding the disposal of infected products.

Information on proper disposal is available from your dealer or from Technical Support at SIBEL S.A.

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1. INSTRUCTIONS OF INSTALLATION AND USE

1.1 MODELS

The Sleep&Go cardiorespiratory polygraph is available in two different models (A and B) with the following features:

Sleep&Go

Channels

A model B model

Nasal cannula

Airow

Snore

CPAP

Thermocouple

Inductive plethysmography band (thoracic)

Inductive plethysmography band (abdominal)

Auxiliary channel

External snore

Limb movements

External EXG

module

EXG 1 EXG 2 EXG 3

External Xpod

SpO

BPM

Pulse wave

Position

Activity

Marks

Bluetooth (real time tests)

Default Opon

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1.2 PACKING LIST

RELACIÓN DE CONTENIDO / PACKING LIST 534-708-120 REV. 4

SCREEN&GO/SLEEP&GO 2014-06

(*)

CUANDO SE ENTREGA LA REFERENCIA 08089 JUNTO CON UN SCREEN/SLEEP&GO NO SE INCLUYE LA REFERENCIA 01420 (PAQUETE DE 2 BANDAS

INDUCTIVAS TAMAÑO XL), PUESTO QUE YA ESTÁ INCLUIDA EN LA REFERENCIA 08088. LA REFERENCIA 01420 SE INCLUIRÁ SÓLO SI EL MÓDULO 08089 SE SUMINISTRA POR SEPARADO.

WHEN THE REFERENCE 08089 IS SUPPLIED WITH A SCREEN / SLEEP & GO DOES NOT INCLUDE REFERENCE 01420 (PACK OF 2-BAND INDUCTIVE SIZE XL), SINCE IT IS ALREADY INCLUDED IN THE REFERENCE 08088. THE REFERENCE 01420 IS INCLUDED ONLY IF THE MODULE 08089 IS DELIVERED SEPARATELY.

1/4

MODELOS/ MODELS

CÓDIGO

CODE

CANT.

QTY.

DESCRIPCIÓN

DESCRIPTION

SCREEN&GO

SLEEP&GO

A B

POLÍGRAFO / POLYGRAPH

_______ 1 SCREEN&GO/SLEEP&GO SN: 347 - _______

Accesorios Estándar / Standard Accessories

06312 1

BANDA DE SUJECIÓN TAMAÑO GRANDE (L) /

FASTENING BELT LARGE SIZE (L)

08049 1

CÁNULA DESECHABLE NASAL / DISPOSABLE NASSAL CANNULA

08087

06309

MÓDULO TERMOPAR (INCLUYE ACTIVACIÓN DEL CANAL) / THERMOCOUPLE MODULE (INCLUDES

CHANNEL ACTIVATION)

• SENSOR TERMOPAR / THERMOCOUPLE SENSOR

08088

06314

01420

07678

MÓDULO DE ESFUERZO TORÁCICO INDUCTIVO (INCLUYE ACTIVACIÓN DEL CANAL) /

INDUCTIVE THORACIC EFFORT MODULE (INCLUDES CHANNEL ACTIVATION)

• INTERFAZ DE AMPLIFICACIÓN BANDA INDUCTIVA ESFUERZO TORÁCICO / THORAX EFFORT

INDUCTIVE BAND AMPLIFICATION INTERFACE

• BANDA INDUCTIVA ELÁSTICA TAMAÑO EXTRA GRANDE (XL) / ELASTIC INDUCTIVE BAND XTRA

LARGE SIZE (XL)

• ANILLA SUJECIÓN / FASTENING RING

08089

06308

01420

(*)

07678

(*)

MÓDULO DE ESFUERZO ABDOMINAL INDUCTIVO PARA SLEEP&GO (INCLUYE ACTIVACIÓN DEL CANAL) /

INDUCTIVE ABDOMINAL EFFORT MODULE FOR SLEEP&GO (INCLUDES CHANNEL ACTIVATION)

• INTERFAZ DE AMPLIFICACIÓN BANDA INDUCTIVA ESFUERZO ABDOMINAL / ABDOMINAL EFFORT

INDUCTIVE BAND AMPLIFICATION INTERFACE

• BANDA INDUCTIVA ELÁSTICA TAMAÑO EXTRA GRANDE (XL) / ELASTIC INDUCTIVE BAND XTRA

LARGE SIZE (XL)

• ANILLA DE SUJECIÓN / FASTENING RING

---

08090

06310

CANAL AUXILIAR (MOVIMIENTO EXTREMIDADES) PARA SLEEP&GO (INCLUYE ACTIVACIÓN DEL CANAL) /

AUXILIARY CHANNEL (LIMB MOVEMENT) FOR SLEEP&GO (INCLUDES CHANNEL ACTIVATION)

• KIT SENSOR MOVIMIENTO EXTREMIDADES / LIMB MOVEMENT SENSOR KIT

---

08091

06346

CANAL AUXILIAR (RONQUIDO) PARA SLEEP&GO (INCLUYE ACTIVACIÓN DEL CANAL) /

AUXILIARY CHANNEL (SNORING) FOR SLEEP&GO (INCLUDES CHANNEL ACTIVATION)

• SENSOR RONQUIDO PIEZOELÉCTRICO /

PIEZOELECTRIC SNORE SENSOR

---

08060 1

TARJETA MEMORIA MICRO SD CON ADAPTADOR SD / MICROSD MEMORY CARD WITH SD ADAPTER

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User’s Manual - Cardiorespiratory polygraph - Sleep&Go

RELACIÓN DE CONTENIDO / PACKING LIST 534-708-120 REV. 4

SCREEN&GO/SLEEP&GO 2014-06

2/4

03673 2

PILAS ALCALINAS AA 1.5V / AA 1.5V ALKALINE BATTERY

08011 1

MALETÍN TRANSPORTE SCREEN&GO

CARRYING CASE SCREEN&GO

--- ---

08010 1

MALETÍN TRANSPORTE SLEEP&GO / CARRYING CASE SLEEP&GO

---

08070

______

08072 08071

1 1

CD SOFTWARE BITMEDLAB (CON LICENCIA) /

CD BITMEDLAB SOFTWARE (WITH LICENSE)

• MANUAL DE USO / USER’S MANUAL (Doc.534-740-MU_)

• MÓDULO BASE DE DATOS / DATABASE MODULE

• MÓDULO ANALISIS AUTOMÁTICO EVENTOS /

AUTOMATIC EVENTS DETECTION MODULE

______ 1

SCREEN&GO MANUAL DE USO / SCREEN&GO USER’S MANUAL (Doc. 534-70S-MU_)

--- ---

______ 1

SLEEP&GO MANUAL DE USO / SLEEP&GO USER’S MANUAL (Doc. 534-7AB-MU_)

---

______ 1

GUÍA RÁPIDA SCREEN - SLEEP&GO / SCREEN-SLEEP&GO QUICK GUIDE (Doc. 534-7AB-GR_)

Accesorios Opcionales / Optional Accessories

08094 1

LECTOR TARJETAS MEMORIA USB PARA PC / USB MEMORY CARD READER FOR PC

08073 1

MÓDULO BITMED VISION PARA BITMEDLAB /

BITMED VISION MODULE FOR BITMEDLAB

---

06976

08098

08012

07677

KIT DE PULSIOXIMETRÍA ADULTOS PARA SCREEN&GOSLEEP&GO (Canales: SPO

, BPM) / ADULT PULSE

OXIMETRY KIT FOR SCREEN&GO-SLEEP&GO (Channels: SpO

, BPM)

• MODULO PULSIOXIMETRIA XPOD /

XPOD PULSE OXIMETRY MODULE

• SENSOR PULSIOXIMETRIA SOFT (ADULTO) /

SOFT PULSE OXIMETRY SPO2 SENSOR (ADULT)

• MUÑEQUERA DE SUJECIÓN / WRISTBAND

08069

08098

08013

07677

KIT DE PULSIOXIMETRÍA PEDIÁTRICO PARA SCREEN&GO/SLEEP&GO (Canales: SPO

, BPM) /

PEDIATRIC PULSE OXIMETRY KIT FOR SCREEN&GO/SLEEP&GO(Channels: SpO

, BPM)

• MODULO PULSIOXIMETRIA XPOD /

XPOD PULSE OXIMETRY MODULE

• SENSOR PULSIOXIMETRIA SOFT (PEDIÁTRICO)/

SOFT PULSE OXIMETRY SPO2 SENSOR (PEDIATRIC)

•

MUÑEQUERA DE SUJECIÓN / WRISTBAND

08078 1

OPCIÓN FIRMWARE CANAL DE RONQUIDO POR PRESIÓN / PRESSURE SNORING CHANNEL FIRMWARE OPTION

08079 1

OPCIÓN FIRMWARE CANAL DE POSICIÓN CORPORAL / BODY POSITION CHANNEL FIRMWARE OPTION

08080 1

OPCIÓN FIRMWARE CANAL DE ACTIGRAFÍA / ACTIGRAPHY CHANNEL FIRMWARE OPTION

08081 1

OPCIÓN FIRMWARE CANAL DE MARCAS DEL PACIENTE / PATIENT’S MARKS CHANNEL FIRMWARE OPTION

08082 1

OPCIÓN FIRMWARE CANAL DE PRESIÓN CPAP / CPAP PRESSURE CHANNEL FIRMWARE OPTION

---

08083 1

OPCIÓN FIRMWARE CANAL DE ONDA DE PULSO / PULSE WAVE CHANNEL FIRMWARE OPTION

---

08084 1

OPCIÓN FIRMWARE MÓDULO BLUETOOTH / BLUETOOTH MODULE FIRMWARE OPTION

---

08022

08251

MÓDULO DE SENSORES EXG /

EXG SENSOR MODULE

• PIEZA ANTI APERTURA TAPA BATERÍAS /

BATTERY COVER BLOCKING PIECE

---

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RELACIÓN DE CONTENIDO / PACKING LIST 534-708-120 REV. 4

SCREEN&GO/SLEEP&GO 2014-06

3/4

08085

08701

01644

02741

KIT DE ELECTRODOS EEG PARA SLEEP&GO / EEG SENSOR KIT FOR SLEEP&GO

• ELECTRODO CUCHARA ORO EXG (PAQUETE 10U) /

EXG GOLD CUP ELECTRODES (PACKAGE 10PC)

• CABLE ADAPTADOR 1MM A 1.5MM /

CABLE ADAPTER 1MM TO 1.5MM

• PUENTE DE INTERCONEXIÓN /

INTERCONNECTION BRIDGE

---

08086

08093

01027

01644

KIT DE ELECTRODOS ECG PARA SLEEP&GO / EKG SENSOR KIT FOR SLEEP&GO

• CABLES PARA ELECTRODOS DE CORCHETE (PAQUETE 10U) / CABLES FOR BUTTON STUD TYPE ELECTRODES

(PACKAGE 10 PC)

• ELECTRODO DE ECG (PAQUETE 50 uni.

) /

ECG ELECTRODE (PACKAGE 50 units)

• CABLE ADAPTADOR 1MM A 1.5MM /

CABLE ADAPTER 1MM TO 1.5MM

---

06346 1

SENSOR RONQUIDO PIEZOELÉCTRICO / PIEZOELECTRIC

SNORE SENSOR

---

07679 1

CÁNULA NASAL DESECHABLE PROTECH (PAQUETE DE 60u) / DISPOSABLE PROTECH NASAL CANNULA (PACK OF 60u)

07680 1

CÁNULA ORO-NASAL DESECHABLE PROTECH (PAQUETE DE 30u) / DISPOSABLE PROTECH ORO-NASAL CANNULA 40cm (PACK OF 30u)

07681 1

CÁNULA ORO-NASAL DESECHABLE SLEEPSENSE (PAQUETE DE 5u) / DISPOSABLE SLEEPSENSE ORO- NASAL CANNULA 60cm (PACK OF 5u)

08049 1

CÁNULA NASAL DESECHABLE SLEEPSENSE /

DISPOSABLE SLEEPSENSE NASAL CANNULA

06311 1

BANDA DE SUJECIÓN TAMAÑO PEQUEÑO (S) / FASTENING BELT SMALL SIZE (S)

06313 1

BANDA DE SUJECIÓN TAMAÑO EXTRA GRANDE (XL) / FASTENING BELT XTRA LARGE SIZE (XL)

01425 1

BANDA INDUCTIVA ELÁSTICA TAMAÑO PEQUEÑA (S) / ELASTIC INDUCTIVE BAND SMALL SIZE (S)

01424 1

BANDA INDUCTIVA ELÁSTICA TAMAÑO MEDIANA (M) / ELASTIC INDUCTIVE BAND MEDIUM SIZE (M)

01421 1

BANDA INDUCTIVA ELÁSTICA TAMAÑO GRANDE (L) / ELASTIC INDUCTIVE BAND LARGE SIZE (L)

01420 1

BANDA INDUCTIVA ELÁSTICA TAMAÑO EXTRA GRANDE (XL) / ELASTIC INDUCTIVE BAND XTRA LARGE SIZE (XL)

01417 1

BANDA INDUCTIVA ELÁSTICA TAMAÑO EXTRA EXTRA GRANDE (XXL) / ELASTIC INDUCTIVE BAND XTRA XTRA LARGE SIZE (XXL)

08701 1

ELECTRODO CUCHARA ORO EXG (PAQUETE 10u) / EXG GOLD CUP ELECTRODES (PACK OF 10u)

---

08093 1

CABLES PARA ELECTRODOS DE CORCHETE (PAQUETE DE 10u) / CABLES FOR BUTTON STUD TYPE ELECTRODES

(PACK OF 10u)

---

01027 1

ELECTRODO DE ECG (PAQUETE DE 50u) / ECG ELECTRODE (PACK OF 50u)

---

ESTÁNDAR

STANDARD

OPCIONAL OPTIONAL

---

NO DISPONIBLE NOT AVAILABLE

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RELACIÓN DE CONTENIDO / PACKING LIST 534-708-120 REV. 4

SCREEN&GO/SLEEP&GO 2014-06

4/4

ADVERTENCIA:

• LOS ARTÍCULOS Y CANTIDADES RELACIONADAS ANTERIORMENTE HAN SIDO CUIDADOSAMENTE COMPROBADAS. EN CASO DE FALTAS O DESPERFECTOS PROCEDAN A COMUNICÁRNOSLO LO MAS PRONTO POSIBLE.

•

SI DETECTA CUALQUIER DAÑO EN EL EMBALAJE, CONTACTE CON SU DISTRIBUIDOR ANTES DE PROCEDER A LA

INSTALACIÓN DEL EQUIPO.

• NO SE DEBE DESPRENDER DE LOS EMBALAJES, BOLSAS, ETC. HASTA QUE VERIFIQUE TOTALMENTE EL CORRECTO FUNCIONAMIENTO DEL EQUIPO.

• EN CASO DE DEVOLUCIÓN DE MATERIAL O EQUIPO EN DEPOSITO, ROGAMOS NOS LO ENVÍEN EN PERFECTO ESTADO, COMPLETO DE ACCESORIOS Y DEBIDAMENTE EMBALADO. CUALQUIER DESPERFECTO OCASIONADO PROVOCARÍA UN CARGO CORRESPONDIENTE EN LA REPARACIÓN O EN LA REPOSICIÓN.

WARNING:

• THE ITEMS AND QUANTITIES RELATED BEFORE HAVE BEEN CAREFULLY CHECKED. IN CASE OF ANY PART IS MISSING OR IS DAMAGED, NOTIFY US AS QUICKLY AS YOU CAN.

• IF YOU DETECT ANY DAMAGE IN THE PACKAGING, CONTACT WITH YOUR DISTRIBUTOR BEFORE PROCEEDING TO INSTALL IT.

• DO NOT THROW AWAY THE PACKAGING, BAGS, ETC. UNTIL THE CORRECT FUNCTIONING OF THE DEVICE IS VERIFIED

• IN THE CASE OF RETURNING THE GOODS, IT WILL BE APPRECIATED THAT YOU SEND THE DEVICE IN PERFECT ORDER, WITH ALL THE ACCESSORIES AND PROPERLY PACKAGED. ANY DAMAGE SUFFERED WILL MAKE A CHARGE CORRESPONDING TO REPAIR OR NEW PARTS.

PREPARADO/PREPARED BY: ................................. FECHA/DATE: .............

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1.3 LAYOUT OF CONTROLS, INDICATORS AND

CONNECTORS

1.3.1 FRONT/TOP/RIGHT PANNEL

SpO2: XPod pulse oximeter connector

Color LCD

Status LED

Joystick

Ther: thermocouple airow

sensor connector

Tho: thoracic effort band connector.

Abd: abdominal effort band connector.

Aux: auxiliary channel connector (suitable for both snore and limb movement sensors)

ExG: ExG module connector

Nasal: cannula nasal cannula connector

1.3.2 LEFT PANNEL

MicroSD memory

card slot

ON/OFF button

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1.3.3 REAR PANNEL

08251 – Battery cover

blocking piece (only with EXG module).

Battery compartment

(2x AA alkaline or

rechargeable batteries).

1.4 INSTALLATION AND START-UP

This system is made of solid-state professional components manufactured under stringent quality controls. However, accidents may occur during the transportation or storage, being

convenient an initial checking of the device and accessories prior to installation. If you detect a deterioration in the package, please

contact the transport company and your supplier immediately,

prior to installation. Do not dispose the packaging until completely

verifying the proper functioning of the system. Use only accessories described in this manual. The use of not recommended accessories could adversely affect both the patient safety and the equipment.

1.4.1 BATTERY PLACEMENT

The Sleep&Go system uses two 1.5V AA batteries. You can use alkaline or rechargeable batteries with, at least, 2450mA/h. Using

smaller capacity batteries diminishes the autonomy. The autonomy in normal use is about 12 hours operating in online mode and 24 hours in holter mode.

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The battery compartment is located on the rear panel, protected by a cap that needs to be removed to proceed to change the batteries

Before opening the baery compartment to replace the baeries please switch o the Sleep & Go.

1.4.2 POWER SAVING MODE

To save power, the device switches off the display after 50 seconds of inactivity (even if it is running a test) and the whole device after 5 minutes if the user does not start a test nor interacts with the

joystick.

1.4.3 BLUETOOTH MODULE INSTALLATION

The PC must have enabled and available this type of communication in order to use the Bluetooth link with the Sleep&Go (optional module). Install the driver and software for the PC Bluetooth module, as detailed in the module user’s manual. You must then

search the Sleep&Go from the Bluetooth software in Windows and

pair the PC with the Sleep&Go. The pairing code corresponds to the last three digits of the Sleep&Go serial number. You will nd the serial number on the label on the back of the Sleep&Go device.

1.4.4 PLACEMENT OF SENSORS AND ELECTRODES

1.4.4.1 PLACEMENT OF THE SLEEP&GO POLYGRAPH

The small size and weight of the Sleep&Go system allows the patient to wear it comfortably fastened with a strap. Follow these steps to fasten the device to the patient:

• Insert the strap between the two guides in the rear side of the Sleep&Go.

• Place the device on the patient’s chest, in a comfortable position

midway between the thoracic effort band (which should be on top) and the abdominal effort band (which should be below).

• Secure the strap by means of the Velcro so that the device stands rm.

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General placement schema

1.4.4.2 NASAL CANNULA

The nasal airow cannula (refs. 07679, 07680, 07681, 08049) is used to acquire the airow, snoring, and CPAP pressure level

signals, by means of the device’s internal pressure transducer.

The placement of the nasal cannula has a signicant impact in

obtaining high quality signals. Follow these steps to place it properly:

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• Place the cannula over the upper lip. Bend the nasal probes

softly until the tips are exposed to the maximum possible

air ow. The tips should not get in contact with the skin or penetrate the nasal orice.

• Wrap the tube around the ears and place it under the chin. Surgical tape can be used to fasten the tubes to the cheeks of

the patient. If necessary, adjust the tubes under the chin.

• Insert the cannula connector in the Luer connector of the Sleep&Go (labeled as “Nassal cannula”) and turn it until secured.

1.4.4.3 THERMOCOUPLE AIRFLOW SENSOR

In addition to the nasal cannula, the Sleep&Go may also use the thermocouple sensor (ref. 06309) in order to measure the

respiratory airow. The thermocouple sensor is to be connected to

the connector labeled as “Ther”.

The quality of the registered signal depends on variables such

as the lters selected in the software, the sensor placement, the patient’s respiration, room temperature and CPAP pressure. Filters

can reduce the noise in the respiratory signal, but they can also add distortion to the signal if used in excess. Filters are applied in the BitmedLab software. Read that software’s manual if you need to modify them.

The placement of the thermocouple sensor has a signicant impact

in obtaining high quality signals. Follow these steps to place it properly:

• Place the thermocouple on the upper lip. Bend the nasal tips

softly until the ends of the sensor are exposed to the maximum

possible air ow. The tips should not get in contact with the

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skin or penetrate the nasal orice.

• Wrap the cable around the ears and place it under the chin.

Surgical tape can be used to fasten the cables to the cheeks of

the patient. If necessary, adjust the sensor cable on the chin.

• Bend the oral probe softly in its position in front of the mouth, so that the end of the sensor is exposed to the greatest oral

ow possible, approximately 1 cm from the mouth. The probe should not touch the skin or the lips, nor penetrate the oral

cavity.

• Insert the sensor connector in the connector of the Sleep&Go labeled as “Ther”.

The ambient temperature affects the magnitude of the signal. If the temperature is similar to the patient’s temperature, the signal level may be very low. On the other side, if the ambient temperature is very different from the patient’s temperature, the signal level will be higher.

The placement of a CPAP mask over the thermocouple sensor may

affect the difference between the patient and the room temperature and may also affect the placement of the thermocouple sensor.

1.4.4.4 THORACIC AND ABDOMINAL EFFORT BANDS

The inductive plethysmography belts (refs. 01425, 01424, 01421,

01420, 01417) supplied with the Sleep&Go are based in the RIP technology (Respiratory Inductive Plethysmography).

• Strap the sensor bands around the patient’s chest and abdomen,

over any clothing.

• Attach the rst wire to the snap that is on the same side of the

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band as the Velcro patch.

• While holding this end to the left of the patient’s center line, wrap the band around the patient’s chest or abdomen.

• Pull the other end over the rst end

and secure the band on the right side of the center line. The band should be snug but not too tight.

• Attach the second wire to the exposed snap.

Make the connecon and disconnecon of the snaps with the interface box disconnected from the computer.

• Make sure the box in the cable that goes to the chest band

is labeled as “Chest” (ref. 06314) and the one going to the abdominal band is labeled as “Abd.“ (ref. 06308).

• Insert the connector from each the respiratory effort belt in the corresponding input connector of the Sleep&Go, labeled as “Thor” for the thoracic belt and “Abd” to the abdominal belt.

• Fix each of the little boxes to the corresponding belt with the aid of the provided strips.

1.4.4.5 PULSE OXIMETER

The system is able to provide the pulse wave, as well as the measurement of the pulse rate and the functional oxygen saturation, based on the technology developed by Nonin Medical

Inc. The external pulse-oximeter (named XPod) (ref. 08098) is to

be connected on the top side of the device. The SpO2 sensor is to

be connected on the free end. Pay special attention to the sensor being used. Please consult the manufacturer before using non-

recommended sensors.

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To place pulse oximeter sensor, follow these steps:

• Place the wristband provided in the patient’s wrist and insert the XPod module into the socket.

• Insert a nger (preferably the index nger) in the sensor until the nger tip reaches the stop. It is not recommended to place this sensor in the thumb. Keep the ngernail of the patient pointing toward the top side of the sensor. Make sure that long ngernails do not interfere with the adequate positioning of the nger.

• To obtain the best results, fasten the cable to the nger, using surgical tape, preferably around the base of the nger. Make

sure that the tape fastening the cable does not restrict blood circulation.

• Take the cable coming out of the wristband over the arm and

connect it to “SpO2” of Sleep&Go.

Furthermore, the following conditions of use should be observed:

• The oximeter must not be used by itself to reach important medical conclusions. Medical caution must always be taken and other means must be used, whenever possible, for conrmation.

• Incorrect use or inappropriate handling of the sensor can cause

damage to the sensor or cable. This would lead to incorrect measurements and readings.

• Remove nail polish or articial nails before applying the sensor,

as they could cause incorrect readings.

• The sensors cannot be sterilized. Do not submerge the sensors in liquid. The sensors must be disconnected from the Sleep&Go prior to cleaning or disinfection.

• The operation of the oximeter sensor may be affected by the presence of strong room lighting. If necessary, the sensor area must be protected (e.g. with surgical tape).

• The oximeter may not be capable of detecting minimal values of saturation with the same degree of accuracy and precision as the maximum values of saturation. It is also possible that it can

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not quantify the degree of existing hyperoxemia.

• Interferences such as movements, abnormal hemoglobins,

intravascular contrasts, states of low perfusion and skin

pigmentation may affect the operation of the pulse oximeter.

• It is unlikely that organisms are transmitted via pulse oximetry.

However, we recommend washing the pulse oximetry sensor for each change of patient with soapy water or disinfectant solution

as specied by the manufacturer.

• The pulse oximetry module and the pulse oximetry probe is CE

marked. The temperature of the area of the probe in contact with the nger will not reach temperatures > 42 °.

• See the instructions for use before use. Strictly follow the

manufacturer’s safety instructions, as well as those specied

in this manual.

• The maximum recommended time of application of an pulse oximeter in the same place is 24 hours. The point of placement

must be checked frequently to determine the position, circulation

and cutaneous sensitivity of the patient. Reaction to the sensors by the patients may be different depending on their state of

health and skin condition. Adhesive material must not be used

if the patient shows an allergic reaction to such material.

• For long-term measurements, it is recommended to use exible

or disposable sensors.

• The adult sensor is for people over 12 years of age (>40 kg).

The pediatric sensor is for children aged between 5 and 12

years of age (15-40 kg).

• The system can measure the pulse rate and functional oxygen

saturation. A functional meter can not be used to evaluate the accuracy of a pulse oximetry sensor or a pulse oximetry monitor.

• Do not use blood ow restrictors because they can lead to loss

of signal.

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1.4.4.6 BODY POSITION AND ACTIVITY

The Sleep&Go records information about the patient’s body position and actigraphy. Both sensors are place inside the Sleep&Go device, so no external accessory is needed.

1.4.4.7 SNORING SENSOR

Apart from the snoring signal obtained from the nasal cannula you may also use a piezoelectric snoring sensor (ref. 06346) to detect the patient’s tracheal sounds during sleep. The piezoelectric snoring sensor can be plugged into the connector labeled as “Aux”, if you’re not using the limb movement sensor. Also, you may connect the sensor in any of the channels provided by the ExG module (optional).

The snoring sensor is placed on the throat of the patient and it generates a signal in response to the vibration produced during snoring. The piezoelectric sensors are based on the movement produced by the vibrations and not on the sounds. Therefore they cancel artefacts related to external noise. The snoring signal is converted into analogical voltage which can be measured.

To place a piezoelectric snoring sensor, follow these steps:

• Tell the patient to imitate a snore while you place your ngers,

slightly off-centre, upon the throat. Try to select a point where the greatest vibration related to the snoring sound is produced.

• Do not place the sensor directly over the larynx.

• Place the sensor with the attest part in contact with the skin and secure it with

surgical tape.

• Insert the snoring sensor connector into the corresponding input of the Sleep&Go (“Aux” connector or any connector in the ExG module).

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1.4.4.8 LIMB MOVEMENT SENSOR

The limb movement sensor (ref. 06310) is used to detect the movements of the patient’s limbs during sleep. The limb movement sensor is to be connected to the “Aux.” connector. However, if you purchased the ExG module you may also connect the sensor to any of its channels.

• To place a limb movement sensor, follow these steps: Place the

sensor in the wrist (inner side of the wrist, over the tendons)

or the patient’s ankle (front side of the ankle), in an area that provides the maximum movement signal, as shown in the gure below. If you put the sensor in the ankle then x it by using the

provided strap.

• Secure the sensor cable to the patient’s skin with hypoallergenic

tape.

• Insert the movement sensor connector in the corresponding input of the Sleep&Go (connector labeled as “Aux” or any of the input channels available in the ExG module).

1.4.4.9 EKG ELECTRODES

We recommend using the electrodes (ref. 02646) provided by the manufacturer. If you are using other electrodes, carefully read the

instructions before using them and make sure they are compatible

with the Sleep&Go system.

The following steps should be taken to place these electrodes:

• Prepare the area where the electrodes are to be placed. The skin must be cleaned adequately using abrasive paste. This

allows a good contact impedance (typically less than 10K).

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• Attach the electrode to the patient’s

skin by removing the electrode lm that protects the adhesive. Place one electrode

on each collar bone.

• Connect the cables (ref. 08093) to the button stud connectors in the electrodes.

• Use a wire adaptor with 2 1.5mm TouchProof connectors to 1mm key

connector (ref. 01644) for connecting the couple of electrodes to the appropriate channel. In order to acquire the EKG signal you must have the ExG module (optional, ref. 08022). Connect the adapter to any of the three ExG channels included in the module. Hold the ExG module to the thoracic effort band.

• Interferences may be reduced by tying together the electrode wires.

• Place a third electrode on the patient’s forehead and connect it

to the neutral input in the ExG module.

• The EKG signal should not be acquired if the device is used at patient’s home.

• According to electrical safety standards and due to the use of electrodes in contact with the patient, the technician must not touch any internal part of the device that is accessible without the use of a tool. For this reason, use the piece 08251 (battery

cover blocking piece) on the battery cover when using the electrodes and the EXG Module.

1.4.4.10 EMG, EOG AND EEG ELECTRODES

We recommend using the cup electrodes (ref. 08701) provided by the manufacturer. If you are using other electrodes, please carefully

read the instructions before using them and make sure they are

compatible with the Sleep&Go system.

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The following steps should be taken to place these cup electrodes:

• Prepare the area where the electrodes are to be placed. The skin must be cleaned adequately using abrasive paste. This

allows a good contact impedance (typically less than 10K).

• Fix the electrode to the patient’s skin by lling the cup with conductive paste and xing it in place with colodion. A hair

dryer can be used to speed up the drying process. When the test is over the electrodes are easyly removed with acetone.

• Use a wire adaptor with 2 1.5mm TouchProof connectors to 1mm key connector (ref. 01644) for connecting the couple

of electrodes to the appropriate channel. In order to acquire the EMG, EOG or EEG signals you must have the ExG module (optional, ref. 08022). Connect the adapter to any of the three ExG channels included in the module. Hold the ExG module to the thoracic effort band.

• To use a common reference for several EEG channels, each electrode must be connected to one of the connectors of the wire adaptors (ref. 01644). Use one or more interconnection bridges (ref. 02741) to interconnect the remaining pole of all referenced channels, so that every channel uses the same reference.

• Interferences may be reduced by tying together the electrode wires.

• Place a third electrode on the patient’s forehead and connect it

to the neutral input in the ExG module.

• The EEG, EOG and EMG signals should not be acquired if the device is used at patient’s home.

cover blocking piece) on the battery cover when using the electrodes and the EXG Module.

In addition to the aforementioned explanations, the following

precautions and considerations should be taken into account while

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using the electrodes:

The conducve part of the electrodes and connectors, must never touch other conducve parts, including the earth connecon.

To prevent the risk of burns, all electrodes must be removed from the paent before using a high frequency (HF) surgical unit.

When several devices are connected to a paent, there is a risk of accumulang leakage currents, which can become dangerous for the paent. Reduce to the absolute minimum the number of devices connected to the paent.

To protect the paent against the eects of electric shock, all electrodes must be removed from the paent before using a cardiac debrillator.

1.4.4.11 EVENT MARKER

During the test (either online or in holter mode), the patient is

allowed to make a mark by simply pressing the joystick for at least 3 seconds. After these 3 seconds the screen lights on and the mark is registered. These marks are used to indicate certain events, such as the patient getting up to the bathroom, taking medication and so on.

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2. OPERATION

The Sleep & Go is tted with a color screen and a joystick to interact

with the options exposed by the device’s software. The top part of the screen displays an info bar with the device status at any time:

This is the screen displayed when the Sleep&Go is switched on:

This screen displays status information and enables starting a new test in holter mode. The icon “MANUAL START” is selected by

default. The patient can not modify the device conguration. Use the joystick to navigate through the different screens that will be introduced. The joystick supports four directions ( , , , ), while pressing it is used to click an option.

2.1 WORKING MODES

Two working modes are available, depending on the way tests are

handled:

Holter mode: in this mode the Sleep&Go stores the tests in a memory card. Later, the tests are transferred to the computer for evaluation. It is designed for home use or at the hospital or clinic. There are two ways of starting a test in holter mode:

Free space in memory card

Battery

status

Date Time

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a. Manual start and stop: the patient starts and stops

manually the recording of the test, through the color

screen and joystick in the Sleep&Go.

b. Automatic start and stop: health personnel program

the Sleep&Go to start and stop automatically the test at a certain date and time.

The device’s batteries last up to 24 hours in holter mode with a single charge.

Online mode: in this mode the test data are sent in real time to

the PC via Bluetooth, the transfer from the memory card not being

necessary after the test. This mode is intended for use in the clinic / hospital or the sleep lab. The device’s batteries last up to 12 hours in online mode with a single charge.

2.2 SYSTEM CONFIGURATION

The setup mode in the Sleep&Go is designed to change the device

conguration (date and time, language, type of batteries used) and

schedule new tests. Only healthcare personnel should access the device settings. To enter to the setup menu of the Sleep&Go do the following:

• Switch on the Sleep&Go and make the following keystrokes on the joystick, one after another and leaving a short interval of

time between each of them: , , , .

• The screen changes and a new icon is displayed: “SYSTEM CONFIG.” (A). Select the “SYSTEM CONFIG.” icon and press the joystick to move to the setup screen.

• Select “MORE OPTIONS” (B).

• Select “CUSTOMIZE” (C).

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A B

C D

• If CPAP channel is activated, BATTERY menu changes to OTHER OPTIONS.

2.3 INITIAL DEVICE SETUP

2.3.1 SETTING THE DATE AND TIME

Once in the “CUSTOMIZE” screen, follow these steps in order to change the date and time in the Sleep&Go:

• Select “DATE AND TIME”.

• Use

and to access each of the options to set the date and time in the device. Use and , to modify

the values in each eld.

• Once you have set the date and

time select “OK. “ To cancel setting the date and time select “CANCEL”.

2.3.2 SETTING THE LANGUAGE

Once in the “CUSTOMIZE” screen follow these steps in order to change the language in the Sleep&Go:

• Select “LANGUAGES”.

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• Use and move along the different available languages. The

selected language is marked with

the symbol.

• When you have set the desired language select “OK. “ If you want to cancel the language settings then select “CANCEL”.

2.3.3 SETTING THE TYPE OF BATTERIES

It is very important that the type of batteries is correctly congured

for the remaining battery life information to be displayed properly.

Alkaline or rechargeable Nickel-Metal Hydride (minimum 2450mAh)

AA batteries should be used. In the “CUSTOMIZE” screen follow these steps:

• Select “BATTERY” or “MORE OPTIONS > BATTERY” in case the CPAP channel is available.

• Use and to select the type of

batteries used in the device. The

type of batteries is marked with the

mark.

• When nished select “OK”. If you

want to cancel setting the type of batteries then select “CANCEL”.

2.3.4 SETING THE UNITS OF THE CPAP CHANNEL

• Select “MORE OPTIONS”.

• Select “BATTERY”.

• Select “CPAP UNITS”

• Select cmH2O or hPa and press OK. If you want to cancel the

setting select CANCEL.

2.4 SWITCHING ON/OFF THE BLUETOOTH MODULE

The Bluetooth module can be turned on and off at any time, in order to reduce battery consumption and increase the battery life.

You need to switch on the Bluetooth module when making realtime tests (online mode). If you are making holter tests there is no need of keeping the module powered.

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The Bluetooth module is supplied by default in the Sleep&Go B Model and is optional in the A Model.

To switch on/off the Bluetooth module follow these steps:

• With the Sleep&Go in the home screen make the following

keystrokes with the joystick: , , , .

• The screen changes and displays a new icon: “SYSTEM CONFIG.” (A). Select “SYSTEM CONFIG.” and press the joystick to move

to the setup screen.

• Select “MORE OPTIONS” (B).

• Select “BLUETOOTH” (C).

• If the Bluetooth module is switched on you will be prompted to

turn it off. If the module is switched off you will be prompted to turn it on (D). Select “OK” or “CANCEL “. When the Bluetooth module is powered a Bluetooth logo is displayed in the status bar. Otherwhise no icon is displayed. The blue Bluetooth logo indicates that the module is on, while the green logo means

that data is being transmitted to the PC.

A B

C D

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2.5 MAKING POLYGRAPHY TESTS IN ONLINE MODE

In this mode, the polygraph transmits the real-time data to the PC

via Bluetooth connection, displaying the signals on the computer screen. The Bluetooth module in the Sleep&Go must be enabled (optional in the A model, supplied by default in the B model).

Make sure the device is switched on and the Bluetooth

communication is enabled (see above).

All new online tests are to be started from the BitmedLab software.

Please refer to the software’s manual for information on how to make an online test.

2.6 MAKING POLYGRAPHY TESTS IN HOLTER MODE

When the device operates in holter there are two different ways to start and stop the tests, either manually or automatically (scheduled).

2.6.1 STARTING AND ENDING A TEST MANUALLY

In this mode either the patient or the technician will start and end the test:

• Switch on the device by pressing for 3 seconds the ON/OFF button.

• Once in the main screen press the joystick (A) to select the

“MANUAL START” icon.

• This starts the recording of the test. If all sensors are properly connected then the signals are displayed on the screen and

the LED on the front panel starts ashing. If any of the

sensors to be acquired is not properly connected the message “CHECK SENSOR” is displayed, giving the opportunity to test the connection. After a few seconds the screen switches off automatically.

• To stop the test just select the “STOP” option or hold down the ON/OFF button for 3 seconds (B).

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A B

2.6.2 SCHEDULED TESTS

The Sleep&Go is built with an internal clock suitable for scheduling

new tests in holter mode at certain dates and times, which also end at the right time as programmed by medical personnel. In this way the patient does not have to interact at all with the Sleep&Go for starting or ending the test.

You can schedule up to 5 consecutive tests. These tests may be

scheduled right from the Sleep&Go device or by using the BitmedLab

software in the PC. This manual describes the programming

procedure in the Sleep&Go. Refer to the software manual for information on the programming process in BitmedLab.

2.6.2.1 SCHEDULING A TEST IN THE SLEEP&GO

• Switch on the Sleep&Go and gain access to the setup mode

by making the following keystrokes on the joystick, one after

another and leaving a short interval of time between each of them: , , , .

• Select the “SYSTEM CONFIG.” icon and press the joystick to

move to the setup screen.

• Select “SCHEDULED TESTS” (A).

• Select “NEW TEST” (B).

• Select the “DATE” eld and set the starting date for the test. Select “OK” when nished (C, D).

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• Select the “TIME” eld and set the starting time for the test. Select “OK” when nished (E).

• Move to the “DURATION” eld and enter the number of hours

and minutes for the test (F).

• Select the option “CHANNELS CONF.”. The device displays all channel congurations stored on the memory card. A channel conguration establishes which channels are recorded during

the test, as well as their sampling rates. There may be up to 10

different channel congurations. A detailed explanation on how to change these congurations is given below. Select which conguration is more suitable for the type of test you want to

do (G).

• Select “SAVE” once all parameters are congured. You may

switch off now the Sleep&Go.

• The device will start automatically the test at the designated date and time. The screen will light for 50 seconds, displaying the signals acquired by the sensors. The front panel LED will

blink during the whole test.

A B

C D

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E F

2.6.2.2 DISPLAYING THE SCHEDULED TESTS

You can see the scheduled tests in the Sleep&Go (up to a maximum

of 5 tests):

• Switch on the Sleep&Go and enter the setup mode by making

the following keystrokes with the joystick: , , , .

• Select the “SYSTEM CONFIG.” icon and press the joystick to

move to the setup screen.

• Select “SCHEDULED TEST”.

• Select “SHOW TEST” (A).

• All scheduled tests are displayed. For more info on any scheduled

test select it (B).

• The screen shows the programming data of the test (onset date

and time, duration, channel conguration) (C).

• To view the channel conguration (enabled channels and

sampling frequencies) select “CHANNELS CONF.” (D).

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A B

C D

2.6.2.3 CHANNEL CONFIGURATIONS

he Sleep & Go may hold up to 10 channel congurations. Each conguration stores which of the available device’s channels will

be acquired, as well as the sampling rates for each of them. The available sample rates depend on each type of channel. Some

channels, such as pulse oximetry or body position, have a xed

sampling frequency, while in others, such as the respiratory effort bands or the ExG channels, the sampling rate can be chosen among several values.

The creation and modication of channel congurations is made in

the BitmedLab software, then they are transferred to the MicroSD memory card. See the software’s manual for more information on this point.

2.7 TRANSFER AND REVIEW OF THE TESTS

Tests must be transferred to the PC prior to review. Several tests

may be stored in the memory of the Sleep&Go before transferring

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them to the PC. Transferring the test immediately after it is nished

is not necessary.

In order to transfer the tests to the PC extract the MicroSD memory card from Sleep & Go and insert it into your PC’s card reader. Most

computers are supplied by default with a memory card reader. If your computer does not have one you can use an USB card reader.

After inserting the memory card in your PC run the BitmedLab

software and download the tests as explained in the software’s manual.

The tests are automatically deleted from the memory card when

they are transferred to the PC. Do not delete the les in the memory card before downloading the tests to the PC.

2.8 FIRMWARE UPDATE

Over time, new versions of the program managing the Sleep&Go

(rmware) might be released, either to improve the operation of

the equipment or to add new features.

• The Technical Service will provide one or several les to be

copied to the MicroSD memory card of the Sleep&Go.

• Insert the memory card in the Sleep&Go and switch it on.

• The rmware update starts automatically. When prompted, conrm that you want to update the rmware.

• When the update is complete the Sleep&Go switches off automatically. Your device is already updated.

• In case you are provided with several les the process will be

repeated as many times as needed.

2.9 DEVICE OPTIONS UPDATE

As mentioned in paragraphs 1.2 and 1.3, the Sleep&Go is available in two different models with increasing features. The available channels may be expanded, though. In case new features are

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purchased please follow these steps in order to update your device:

• The Technical Service will provide one le to be copied to the

MicroSD memory card of the Sleep&Go.

• Insert the memory card in the Sleep&Go and switch it on.

• The update starts automatically. When prompted, conrm that

you want to update the device’s features.

• When the update is complete the Sleep&Go switches off

automatically. Your device is already updated and the new

channels are available from now on.

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3. TECHNICAL SPECIFICATIONS

3.1 GENERAL DATA

Useful life for Sleep&Go and ExG module:

7 years

Useful life for Xpod pulseoximeter module:

5 years

Baery type / baery life:

2x AA alkaline baeries or AA NiMh rechargeable baeries (2450mAh minimum) / 12h in online mode, >24h in holter mode.

Enclosure protecon degree: IP22

Memory type: MicroSD

Device classicaon (EN60601-1):

Class: internally powered

Type BF applied parts, not protected against debrillator

Input impedance: 20 MW

CMRR (common mode rejecon rao):

>95dB

Signal input connectors:

Pressure transducer (airow, snoring, CPAP pressure)

Thermocouple, thoracic eort, abdominal eort, polygraphic auxiliary, ExG channels (x3)

Pulse oxymeter

Acmetry

Body posion

Event marker

LUER connector

1 mm key connector

Specic 3-pin connector

Internal

Joysck

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Storage sampling rate (soware selectable):

Airow (pressure transducer)

Snoring (pressure transducer)

CPAP pressure

Thermocouple

Thoracic eort

Abdominal eort

Polygraphic aux.

ExG channels (x3)

Pulse rate

Oxygen saturaon

Plethysmographic wave

Acmetry

Body posion

Event marker

Selectable: 25, 50, 100 samples/s

Selectable: 50, 100, 250 samples/s

1 sample/s

Selectable: 10, 25 samples/s

Selectable: 25, 50, 100 samples/s

Selectable: 100, 250 samples/s

1 sample/s

75 samples/s

Selectable: 10, 25, 50 samples/s

1 sample/s

Resoluon:

Airow. (pressure transducer), snore (pressure transducer), thermocouple, thoracic eort, abdominal eort, polygraphic aux., ExG channels (x3), acmetry

Pulse rate, oxyen saturaon, plethysmographic wave

Body posion

Event marker

CPAP pressure

12 bits

8 bits

1cmH

0 or 1hPa

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Sample storage size: 16 bits per sample

Input range:

Thermocouple, thoracic eort, abdominal eort, polygraphic aux, ExG channels (x3)

Airow (pressure transducer)

CPAP pressure

Snoring (pressure transducer)

Pulse rate

Oxygen saturaon

Plethysmographic wave

Acmetry

Body posion

+/- 5 mVpp

+/- 4 cmH

O (3.9 hPa) over the cannula aprox.

0 - 20 cmH

O (19,6 hPa)

+/- 0.5 cmH2O (0.49 hPa) over the cannula aprox.

18 – 300 BPM (1/min)

0 – 100 %

0 – 255

aprox. +/- 30 mg (300 m/s

)

Supine, prone, le, right, seated

Linearity:

Resp. airow (pressure transducer), snore (pressure transducer)

Thermocouple, thoracic eort, abdominal eort, polygraphic aux., ExG channels (x3), acmetry

+/- 3%

Precision:

CPAP pressure

Pulseoximeter

+/- 2cmH

O (1,96 hPa)

(See pulseoximeter table)

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Fixed hardware lters:

Thermocouple, thoracic eort, abdominal eort

Polygraphic aux.

ExG channels (x3)

Airow (pressure transducer)

CPAP pressure

Snoring (pressure transducer)

Pulse rate

Oxygen saturaon

Plethysmographic wave

Acmetry

Body posion

0.05 – 10 Hz

0.05 – 50 Hz

0.05 – 250 Hz

0.05 – 50 Hz

0.02 Hz

30 – 250 Hz

0.5 – 25 Hz

PC communicaon interface: Bluetooth (opon)

Environmental condions:

In operaon (*)

Transportaon and

storage (*)

Temperature: 5ºC to 40ºC Relave humidity: 15-93% (without condensaon) Barometric pressure: 700hPa to 1060hPa (approx. 2950 to -350m)

Temperature:

-20ºC to +60ºC Relave humidity: <93% (without condensaon)

Dimensions: 90 x 90 x 25 mm

Weight: < 200 g

(*) The condions may vary in some of the accessories (like AgCl electrodes Ref. 02646, EXG silver cup electrodes Ref. 08701 or Cable for buon stud type electrodes Ref. 08093).

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3.2 PULSE OXIMETER TECHNICAL SPECIFICATIONS

The pulse oximeter of the unit is based on the technology of NONIN MEDICAL, INC.

Range of values / resoluon:

Oxygen saturaon

Pulse rate

0-100% / 1%

18-321 / 1 pulse, 0 = erroneous value

Precision

SpO2 (70-100%) (±1DS)

Pulse rate

No movement:

Finger clip sensor: adults, paediatric: ±2 digits; neonates: ±3 digits

Flexible sensor: adults, paediatric, neonates: ±3 digits

Movement:

Finger clip sensor: adults, paediatric: ±2 digits; neonates: ±3 digits

Flexible sensor: adults, paediatric: ±3 digits; neonates: ±4 digits

Low perfusion:

All sensors: adults, paediatric: ±2dígitos; neonates: ±3 digits

No movement (18-300 BPM):

Finger clip sensor/exible sensor: adults, paediatric, neonates: ±3 digits

Movement (40-240 BPM):

Finger clip sensor/exible sensor: adults, paediatric, neonates: ±5 digits

Low perfusion (40-240 BPM):

Finger clip sensor/exible sensor: adults, paediatric, neonates: ±3 digits

Measuring wavelength / power Red: 660nm. / 0.8W

Infrared: 910nm. / 1.2mW

Maximum applicaon me Consult the operang instrucons of the pulsioximetric

sensor

Biocompability and toxicity Consult the operang instrucons of the pulsioximetric

sensor

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1. All precision specications were determined from studies of hypoxia induced in healthy adult volunteers, of both sexes, from Caucasian, Indian and African ethnic group.

2. Standard Deviation. Due to the statistic distribution of the pulse oximeter measurements , only about two-thirds of the pulse oximeter measurements can be expected to be found within ±Arms of the value measured by a COoximeter.

3.3 CONDITIONS OF OPERATION AND STORAGE OF

ACCESSORIES

Although the device and the EXG module stands temperatures between -25 and 70 ° C, the specied temperature range is lower (-20 ° C and 60 ° C) in order to ensure the proper storage of most

accessories.

Exceptionally, ECG electrodes (Ref. 02646), silver cup EXG electrodes

(Ref.08701) and the cable for button-stud type electrodes (Ref

08093) support lower storage temperatures. The following table shows the conditions for these accessories:

Temperature

transportation/

storage

Humidity

transportation/

storage

ECG electrodes (Ref.

02646)

10 to 40ºC

< 93% (without

condensation)

EXG silver cup electrodes

(Ref.08701)

10 to 50 ºC

20 - 80% (without

condensation)

Cable for button stud type electrodes (Ref

08093)

10 to 50ºC

20 - 80% (without

condensation)

3.4 APPLICABLE STANDARDS

The Sleep&Go has the CE Marking (CE 0197). The CE mark is a statement that the Sleep&Go fullls the guidelines established by

the EU for medical devices.

The Sleep&Go is manufactured by SIBEL and the system (including the software) meets the following standards and regulations:

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Recommendations:

• National consensus document on the apnea-hypopnea syndrome (SAHS). Spanish Sleep Group (GES), September 2005.

• The AASM Manual for the Scoring of Sleep and Associated Events, 2007

European Directive 93/42 EEC (R.D: 1591/2009):

• EC marking Class II a

Safety:

• EN 60601-1:2006 + AC:2010: Electrical safety (3rd edition).

• EN60601-1:1990+A1:1993+A2:1995+A11:1993+A12:1993

+A13:1996

• EN 60601-2-26:2003 Electromedical Devices. Part 2: Special

Safety Requirements for Electroencephalographs.

• EN 60601-2-40:1998 Safety requirements for Electromyographs.

• EN 60601-1-11:2010 General requirements for basic safety

and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

EMC:

• EN 60601-1-2:2007+AC:2010 EMC in medical devices (No life support)

See Annex 1. Electromagnetic compatibility

Software:

• EN 62304:2006+AC:2008 Medical device software - Software life-cycle processes

Usability:

• EN 60601-1-6:2010 Medical Electrical Equipment – Part 1-6

General requirements for basic safety and essential performance

- Collateral standard: Usability

• EN 62366:2008 Medical Devices – Application of usability engineering to medical devices

Pulse oximetry:

• ISO 80601-2-61:2011 Special requirements for basic safety and essential operation characteristics of pulse oximeters for medical use

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Biocompatibility:

• EN ISO 10993-1:2009+AC:2010 Biological evaluation of medical devices

Vibration and temperature:

• Levels according to EN 60601-1-11:2010 (covers ISO 806012-61)

• Tests according to EN 680068-2-27:1993 and EN 680068-264:1994

Environmental conditions:

• Levels and tests according to EN 60601-1-11:2010

Symbology:

• EN ISO 15223-1:2012 and EN 980:2008 Symbols to be used with medical device labels, labelling andi nformation to be suplplied.

Packaging and labelling

• Packaging and packaging waste directive 94/62/EC

• Regulation EC 1272/2008 on classication, labelling and packaging of substances and mixtures (REACH)

Information supplied by the manufacturer:

• EN 1041:2008 Information supplied by the manufacturer of medical devices

Electrical and electronic waste:

• Electrical and electronic equipment and waste management. Transposition of the directive WEEE 2002/96/EC

System quality:

• Manufactured according to the SIBEL S.A. Quality Manual, which is compliant with EN ISO 13485:2012+AC:2012 and EN ISO 9001:2008

Risk Management:

• EN ISO 14971:2012

Radio equipment and communication terminals:

• EN 300328 v1.7.1:2006

The user should follow:

• Data protection: Directive 95/46/EC

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In addition, although outside the scope and intended use of the device, some security aspects from the following standards have been applied: EN 60601-2-49:2001 EN 60601-2-27:2006 + CORR: 2006

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4. SYMBOLOGY

4.1 SYMBOLOGY OF THE SLEEP&GO

SERIAL NUMBER

MANUFACTURER (manufacture date, name and address of the manufacturer)

BATCH NUMBER

REFERENCE

CONSULT INSTRUCTIONS FOR USE

WARNING

START UP (STANDBY)

BF APPLIED PARTS

NO SPO

ALARMS

IP22 (see section WARNINGS AND PRECAUTIONS)

DISPOSAL OF WASTE ELECTRICAL / ELECTRONIC

ACORDING TO THE RAEE DIRECTIVE

NEUTRAL CONNECTOR

BATTERIES

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4.2 SYMBOLOGY OF THE ACCESORIES AND PACKAGING

CE MARKING

WARNING

DO NOT REUSE

BATCH NUMBER

REFERENCE

LATEX FREE

PHT (CONTAINS PHTHALATES)

MANUFACTURER (manufacture date, name and address of the

manufacturer)

AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

DISPOSAL OF WASTE ELECTRICAL / ELECTRONIC ACORDING

TO THE RAEE DIRECTIVE

TEMPERATURE LIMITATION

SERIAL NUMBER

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MANUFACTURING DATE

LATEX FREE

DO NOT STERILIZE

U.S. FEDERAL REGULATION RESTRICTS THIS DEVICE TO SALE

BY ORDER OF PHYSICIAN. MAY ALSO BE APPLICABLE IN OTHER

COUNTRIES

PHT (CONTAINS PHTHALATES), DEHP (CONTAINS DIETILHEXIL

PHTALATE)

HUMIDITY LIMITATION

USE BY

STACKING LIMITATION

THIS WAY UP

FRAGILE

KEEP AWAY FROM WATER

PREASURE LIMITATION

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4.3 VALIDATED ACCESSORIES

The Screen&Go device is used in combination with other medical accessories manufactured by SIBEL S.A. or by other manufactures. We only recommend the use of these accessories for proper

operation of the equipment (see section 1.2 PACKING LIST).

The sensors used by other manufacturers are:

Accessory Manufacturer SIBEL

reference

Manufacturer

reference

THERMOCOUPLE SENSOR S.L.P. INC. 06309 1401S-BI

SOFT PULSE OXIMETRY SPO

SENSOR

UNIMED MEDICAL

SUPPLIES INC.

08013 U101S-08

SOFT PULSE OXIMETRY SPO

SENSOR

UNIMED MEDICAL

SUPPLIES INC.

08012 U401S-08

DISPOSABLE NASSAL CANNULA S.L.P. INC. 08049 15805-2-FT

DISPOSABLE PROTECH NASAL

CANNULA (PACKAGE 60PC)

PRO-TECH 07679 P1328-60

DISPOSABLE PROTECH ORO-NASAL

CANNULA (PACKAGE 30PC)

PRO-TECH 07680 P1343

DISPOSABLE SLEEPSENSE ORO-

NASAL CANNULA (PACKAGE 5PC)

S.L.P. INC. 07681 14802-2-FT

DISPOSABLE SLEEPSENSE NASAL

CANNULAR

S.L.P. INC. 08049 15805-2-FT

THORAX EFFORT INDUCTIVE BAND

AMPLIFICATION INTERFACE

S.L.P. INC. 06314 9102S-BI

ABDOMINAL EFFORT INDUCTIVE

BAND AMPLIFICATION INTERFACE

S.L.P. INC. 06308 9101S-BI

FASTENING BELT SMALL SIZE (S) S.L.P. INC. 06311 1348B

FASTENING BELT LARGE SIZE (L) S.L.P. INC. 06312 1341

FASTENING BELT EXTRA LARGE

SIZE (XL)

S.L.P. INC. 06313 1340

ELASTIC INDUCTIVE BAND SMALL

SIZE (S)

S.L.P. INC. 01425 9002-L40

ELASTIC INDUCTIVE BAND MEDIUM

SIZE (M)

S.L.P. INC. 01424 9002-L60

ELASTIC INDUCTIVE BAND LARGE

SIZE (L)

S.L.P. INC. 01421 9002-L90

ELASTIC INDUCTIVE BAND XTRA

LARGE SIZE (XL)

S.L.P. INC. 01420 9002-L120

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Accessory Manufacturer SIBEL

reference

Manufacturer

reference

ELASTIC INDUCTIVE BAND XTRA

XTRA LARGE SIZE (XXL)

S.L.P. INC. 01417 9002-L150

LIMB MOVEMENT SENSOR KIT S.L.P. INC. 06310 1770S-KIT-BI

PIEZOELECTRIC SNORE SENSOR S.L.P. INC. 06346 1250S-BI

EXG GOLD CUP ELECTRODE

(PACKAGE 10PC)

GRASS

TECHNOLOGIES

08701 F-E5GH-30

CABLE ADAPTER 1MM TO 1.5MM PLASTICS ONE, INC. 01644 249497X04010XXX

INTERCONNECTION BRIDGE PLASTICS ONE, INC. 02741 455455X01010XXX

CABLE FOR BUTTON STUD TYPE

ELECTRODES (PACKAGE 10PC)

SPES MEDICA S.R.L. 08093 S2231050261

ECG ELECTRODE (PACKAGE 50PC) TELIC 01027 LF-50

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Annex 1: Electromagnetic compatibility

5. CLEANING AND MAINTENANCE

The Sleep&Go polygraph requires, like any electronic equipment,

a maintenance in order to:

• Ensure the safety of the patient, the operator and its environment.

• Ensure the reliability and accuracy of the functions for which the Sleep&Go was developed.

5.1 CLEANING

To clean the unit and its accessories, excluding the sensors and electrodes, use a damp cloth and mild (hand) soap. To disinfect the device you can use alcohol (ethyl or isopropil). Do not use other

chemical products or detergents for domestic use. Please read carefully the SAFETY section.

Properly dispose the disposable sensors and single-use electrodes

immediately after use. Nasal cannulas are single use and must be replaced with each patient.

For the cleaning and disinfection of reusable sensors and electrodes, please refer to the information provided by its manufacturer.

The device can not be sterilized. For the cleaning and disinfecon of sensors and electrodes, please refer to the informaon provided by its manufacturer.

All sensors should be cleaned properly aer each use and before use in a new paent.

5.2 PREVENTIVE MAINTENANCE

Preventive maintenance consists of all actions needed to keep the equipment in good working order.

5.2.1 ACTIONS TO BE TAKEN BY THE USER

Check periodically that all cables, external accessories and other

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items are in perfect condition, not broken and with no external damage. Pay special attention to the cables and connectors.

It is also advisable from time to time to start a test and check that

the connected sensors respond correctly.

If you detect any problems that you can not solve, please get in contact with the customer service of SIBEL S.A. or your distributor for servicing and repair.

You can also check the “Known abnormalities report” (534-701-

MU2) available to the user from SIBEL S.A.

5.2.2 ACTIONS TO BE TAKEN BY QUALIFIED PERSONNEL

The Medical Device Directive 93/42/EEC recommends the regular servicing and / or calibration to ensure the reliability of the medical devices and the safety of patients, users and the environment.

The general technical verication of safety systems, settings and

features being part of the device, must be made according to the

Procedure of Verication and Adjustment for the Sleep&Go, of

SIBEL S.A.

These operations must be carried out by service personnel from the manufacturer or distributor. The latter, must be in possession of a written authorization from SIBEL S.A., at least during the warranty period, in order to perform such maintenance.

The manufacturer is not responsible for malfunction or damage to the equipment resulting from poor maintenance done by personnel

not certied in writing or belonging to SIBEL S.A.

Accessories and spare parts should always be original and requested to the manufacturer or authorized dealer to ensure the proper functioning of the polygraph.

Periodic functional and metrological verication is necessary to

ensure the operation of equipment over the life of the product. The manufacturer recommends annual inspections by an authorized service center, and in any case not exceeding two years, according

to the verication and adjustment procedures specied by the

manufacturer and applied during the manufacture of the equipment.

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5.3 CORRECTIVE MAINTENANCE

Corrective maintenance is the process of leaving the device in

good conditions of use when it stops working due to malfunction

or misuse.

If you detect a fault in the equipment that prevents normal operation, please contact the SIBEL S.A. Customer Service Centre, specifying the type of problem suffered.

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ANNEX 1. ELECTROMAGNETIC COMPATIBILITY

Manufacturer’s guide and statement – electromagnetic emissions

The SCREEN&GO/SLEEP&GO is designed to be used in the electromagnetic environment specied below. The customer

or user must ensure that it is used within this environment.

Emissions Test Compliance level Guide – Electromagnetic environment

Radiated RF Emissions

CISPR 11 (EN 55011)

Group 1

Class B.

The SCREEN&GO/SLEEP&GO uses RF energy

only for internal use. Therefore its emissions are

very low and unlikely to cause any interference to

nearby electronic devices.

Conducted RF Emissions

CISPR 11 (EN 55011)

Not applicable The SCREEN&GO/SLEEP&GO runs on batteries.

Harmonic Emissions

EN-IEC 61000-3-2

Not applicable The SCREEN&GO/SLEEP&GO runs on batteries.

Flicker and tension uctuations

EN-IEC 61000-3-3

Not applicable

The SCREEN&GO/SLEEP&GO runs on batteries.

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Manufacturer’s guide and statement –electromagnetic immunity

The SCREEN&GO/SLEEP&GO is designed to be used in the electromagnetic environment specied below. The customer or user of the SCREEN&GO/SLEEP&GO must ensure that it is used in this environment.

Immunity Test Test level EN-IEC 60601 Compliance level

Guide Electromagnetic

environment

Electrostatic discharge (ESD)

EN-IEC 61000-4-2

±6 kV in contact

±8 kV in air

±6 kV in contact

±8 kV in air

The oor must be made of wood, cement or ceramic. If the oor is covered with synthetic material, the

relative humidity must be at

least 30 %.

Electrical fast transient/burst

EN-IEC 61000-4-4

±2 kV feeder cables and earth

lines

±1 kV for input/output lines

Not applicable

The SCREEN&GO / SLEEP&GO runs on

batteries.

The length of the E/S lines

is less than 3 m.

Surge

EN-IEC 61000-4-5

±1 kV in differential mode

±2 kVin common mode

Not applicable

The SCREEN&GO / SLEEP&GO runs on

batteries.

Voltage dips, short

interruptions and voltage

variations on power supply

input lines

EN-IEC 61000-4-11

<5 % Ut (>95 % drop of Ut) for

0.5 cycles

40 % Ut (60 % drop of Ut) for 5 cycles

70 % Ut (30 % drop of Ut) for 25 cycles

<95 % Ut (>5 % drop of Ut) for 5 seconds

Not applicable

The SCREEN&GO / SLEEP&GO runs on

batteries.

Magnetic eld 50 / 60 Hz

EN-IEC 61000-4-8

3 A/m 3 A/m

The magnetic eld in the room must be low enough

to ensure the performance

of the test.

Note: Ut is the alternating current power tension prior to the application of the test.

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Manufacturer’s guide and statement –electromagnetic immunity

The SCREEN&GO / SLEEP&GO is designed to be used in the electromagnetic environment specied below. The customer

or user of the SCREEN&GO / SLEEP&GO must ensure that it is used in this environment.

Immunity Test

Test Level EN-IEC

60601

Compliance

level

Guide – Electromagnetic environment

Portable and mobile RF Communications units must

be used no closer to any part of the SCREEN&GO /

SLEEP&GO, including cables, than the recommended

separation distance calculated for the equation

applicable to the transmitter frequency.

Recommended separation distance

Conducted RF

EN-IEC 61000-4-6

3 Vrms

from 150KHz to 80 MHz

3 Vrms

from 80 MHz to 800 MHz

Radiated RF

EN-IEC 61000-4-3

3 V/m

from 80 MHz to 2.5 GHz

3 V/m

from 80 MHz to 800 MHz

from 800 MHz to 2.5 GHz

where P is the maximum power output of the

transmitter in watts (W) according to the manufacturer

of the transmitter and d is the recommended

separation distance in metres (m).

Field intensities from permanent RF transmitters,

determined by an electromagnetic measurement of

the place a, must be less than the level of compliance

in each margin of frequency b.

Interferences may appear in the vicinity of units

marked with this symbol:

Note 1. At 80 MHz and 800 MHz, apply the highest frequency margin.

Note 2. These recommendations may not be applicable in all possible situations. Electromagnetic propagation is affected

by the absorption and reection of structures, objects, and persons.

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The eld intensities emitted by permanent transmitters such as base stations for radiotelephones (mobile-cell phones,

wireless) and mobile radios, amateur radio operators, AM, FM radio and TV transmissions, cannot be theoretically

calculated with any accuracy. To know the electromagnetic environment due to permanent RF transmitters, electromagnetic

measurements of the place of use must be considered. If the eld intensity of the place of use is superior to the level of

compliance, it must be observed whether the behaviour of the SCREEN&GO / SLEEP&GO is normal. Otherwise, additional

measurements such as the reorientation or change in placement of the SCREEN&GO / SLEEP&GO may be necessary.

Above the frequency range from 150 kHz to 80 MHz, the eld intensity must be less than 3 V/m.

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Recommended separation distances between mobile and portable RF communications units and the

SCREEN&GO/SLEEP&GO

The SCREEN&GO/SLEEP&GO is designed to be used in an electromagnetic environment in which radiated RF disturbances

are controlled. The customer or user of the SCREEN&GO/SLEEP&GO can help to prevent interferences by keeping a

minimum distance between mobile and portable RF communications units (transmitters) and the SCREEN&GO/SLEEP&GO

as recommended below, according to the power output of the communications unit.

Maximum

power

output of the

transmitter

Separation distance depending on the transmitter frequency

From 150 kHz to 80 MHz

From 80 MHz to 800 MHz From 800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.69 3.69 7.38

100 11.67 11.67 23.33

For transmitters with a maximum power output not listed above, the recommended separation distance d in metres (m) can

be estimated using the applicable equation according to the transmitter frequency, where P is the maximum power of the

transmitter in watts (W) according to the manufacturer of the transmitter.

Note 1 At 800 MHz, apply the highest frequency margin

Note 2 These recommendations may not apply in all possible situations. Electromagnetic propagation is affected by the

absorption and reection of structures, objects and persons.

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ANNEX 2. TROUBLESHOOTING GUIDE

The Sleep&Go does not start

• Make sure the batteries are placed according to the polarity in

the battery compartment.

• Be sure to use AA alkaline or NiMH rechargeable batteries of at

least 2450mAh.

• Make sure you press the power button for at least 3 seconds.

The PC can not communicate with the device

• Make sure you have purchased the Bluetooth option in your

Sleep&Go.

• Make sure the Sleep&Go is switched on and the LED on the

front panel is lighting.

• Verify that the Bluetooth option is activated in the Sleep&Go.

• Verify that the Bluetooth module in the PC is enabled and working properly.

In a new test the message “CHECK SENSOR” is displayed

on screen

• Check that the erroneous sensor is correctly connected. If

the problem is not solved after 5 minutes, the message will disappear.

The signals of the electrodes look noisy or distorted

• In the case of the electrodes, make sure that the skin-electrode impedance is good. Check the PLACEMENT OF SENSORS AND

ELECTRODES section, with suggestions on the placement of the electrodes.

• Check the connection of the ground electrode. This electrode

plays an important role in signal quality.

• Twist the wires of the different electrodes to reduce the environmental noise.

• In the BitmedLab software, check that the lters currently

selected are appropriate for the type of signal being acquired.

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Pulse oximetry signals are null

• Make sure the pulse oximeter sensor is correctly connected to the patient, as indicated the PLACEMENT OF SENSORS AND

ELECTRODES section.

• Make sure the pulse oximetry sensor connector is properly

plugged into the top panel of the Sleep&Go.

• Make sure the red light in the pulse oximetry sensor switches

on when connected to the Sleep&Go.

Bitmed SLEEP&GO User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual