smartsigns MiniPlus Instructions for Use 2012

Quality, Reliability & Safety This section contains important safety information related to the use of the Smartsigns® MiniPulse pulse oximeter. Other important safety information appears throughout the manual Before using this equipment, please study this manual carefully and familiarise yourself with the controls, displays and operating techniques. All modifications and repairs must be carried out by a qualified service engineer, agent or hospital technician authorised by Huntleigh Healthcare.

Atttention, consult accompanying documents / Instructions for Use Warning

The Smartsigns® MiniPulse pulse oximeter should only be operated by qualified personnel.

Warning

Do not use the Smartsigns® MiniPulse pulse oximeter in the presence of flammable anaesthetics.

Warning

Apart from the batteries, there are no user-serviceable parts inside the instrument.

Warning

To ensure accurate performance and prevent device failure, do not expose the Smartsigns® MiniPulse pulse oximeter to extreme moisture.

Caution

The Smartsigns® MiniPulse pulse oximeter is intended only as an adjunct to patient assessment. It must be used in conjunction with all clinical signs and symptoms

Warning

Pulse oximetry readings and pulse signals can be affected by certain ambient, environmental and certain patient conditions.

Warning

Do not use the Smartsigns® MiniPulse during magnetic resonance imaging (MRI) scanning

Caution

Do not autoclave, or use ethylene oxide sterilization process on any part or accessory of the system. Do not immerse the system in any liquid.

Caution

Electromagnetic Compatibility (EMC). This product complies with the requirements of applicable EMC Standards. The use of accessories not specified by the manufacturer may result in increased emissions by, or decreased immunity of, the equipment, affecting its performance.

Quality Reliability & Safety

1.

3

Introduction

2.

Introduction

2.1

Unpacking Carefully remove the Smartsigns® MiniPulse and its accessories from the shipping carton. Save the packing materials in case the device must be shipped or stored.

2.2

Preliminary Checks Huntleigh Healthcare takes every precaution to ensure that their products reach you in perfect condition. We recommend that a thorough visual inspection is made prior to installation. Should any damage be evident or any part missing, please ensure that Huntleigh Healthcare, Diagnostic Products Division are informed at once. Each system is supplied with the following accessories: Item 1 x Smartsigns MiniPulse 1 pulse oximeter ®

MP1 •

1 x Smartsigns MiniPulse 1R pulse oximeter

•

®

1 x SpO2 Sensor

•

4 x AA high capacity alkaline batteries

•

•

4 x Rechargeable AA NiMH batteries

•

1 x Desk stand with integrated charger

•

1 x Charger wall cube

•

1 x Instructions for Use

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MP1R

•

•

Recommended Clinical Applications The Smartsigns® MiniPulse handheld pulse oximeter is intended for noninvasive continuous or spot check monitoring of functional arterial oxygen saturation (SpO2%), and pulse rate.

2.3.1

Intended Use

Introduction

2.3

The Smartsigns® MiniPulse pulse oximeter is intended for use by healthcare professionals for monitoring adult, paediatric and neonatal patients in hospitals and hospital-type facilities. A range of sensors are available for use with the MP1/MP1R. These are listed in section 2.4 along with details of each application site. Under low perfusion or patient motion conditions, the displayed pulse rate and SpO2 may become erratic or intermittent. In these circumstances, reposition the sensor and ensure the patient remains still.

2.3.2

Indications for Use

The specific medical indications for the use of this device are: • • • •

This device is a prescription device. This device is reusable and is intended for spot or continuous measurement. This device is intended to display oxygen saturation, heart rate and pulse strength or pulsatile signal. This device is intended to indicate an alarm if the measured saturation or heart rate are outside user-set alarm limits.

Warning

The Smartsigns® MiniPulse pulse oximeter is designed for attended monitoring only and must be used under the direct observation of a qualified health care provider.

Warning

The MP1R must not be charged when connected to a patient. The MP1R cannot be used while being charged.

Warning

Any doubt concerning the accuracy of any measurement, an alternative method should be used.

Warning

In extreme situations, tissue damage can be caused by incorrect application or duration of use of the SpO2 probe. Regularly inspect the probe site.

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Introduction

Caution

Ambient light, movement, low patient perfusion, electromagnetic interference, artefacts, dysfunctional haemoglobin, and certain dyes, may interfere with the pulse oximeter’s function.

Caution

Do not autoclave, or use ethylene oxide sterilization process on any part or accessory of the system. Do not immerse the system in any liquid.

2.3.3

Contra Indications

Inaccurate measurements may be caused by: • • • • •

2.4

2.5

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Excessive patient movement Venous pulsations Intravascular dyes, such as indocyanine green or methylene blue Significant levels of dysfunctional haemoglobin Defibrillation

Recommended Sensors Description

Application Site

Part No.

Adult Sensor

Finger

ACC-VSM-171M

3178 Paediatric Sensor

Finger

ACC-VSM-170

3043 Universal Y Sensor

Finger/Toe - Adult/ Paediatric Hand/Foot - Infant

ACC-VSM-169

3025 Infant Wrap Sensor

Toe

ACC-VSM-167

3026 Neonatal Wrap Sensor

Foot

ACC-VSM-168

Accessories Item

Part No.

Pole Clamp

ACC47

Carry Case

ACC-VSM-172

Desk Stand (MP1)

ACC-VSM-173

Desk Stand with Integrated charger (MP1R)

ACC-VSM-174

Controls, Indicators, Symbols & Displays

3.1

Front panel Item

Description

1

Sensor connection

2

Loudspeaker

3

Protective grip

4

Display

5

Front Panel

6

Keypad

1

2

3 4

5 6

3.2

Controls, Indicators, Symbols and Displays

3.

Keypad Button

Description

Button

Description

Power - ON / OFF Key

Up Key

MENU – Alarm limits and Pulse tone setting

Down Key

Alarm suspend - turns the alarms ON or OFF. Press and hold for 2 seconds to permanently disable the alarms; the system will sound a confirmation tone.

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Controls, Indicators, Symbols & Displays 8

3.3

Displays and Audible Alarms

4

1 3 2 Item

Description

1

%SpO2

• Patient’s saturation • ‘Flashing’ alarm threshold exceeded

2

♥/min

• Patient’s pulse rate • ‘Flashing’ alarm threshold exceeded

3

Pulse Strength

• 8-segment bar graph pulse indicator (PI) and pulse strength

4

Alarm suspend

• Illuminated - Alarm OFF

Rear panel Item

Description

1

Probe socket

2

Probe storage

3

Belt Clip

4

Rear panel

5

Battery cover

1

2 3 4

Symbol

Description Attention, consult accompanying documents / Instructions for Use. Type BF applied part

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Controls, Indicators, Symbols & Displays

3.4

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Controls, Indicators, Symbols & Displays

3.5

Desk Stand / Charger (MP1R Only)

Symbol

Only use the PSU provided with the product. Class II Electrical Equipment

MODEL No. SERIAL No.

DSR

XXXXXXXXXXXX Huntleigh Healthcare Diagnostic Products Division 35 Portmanmoor Rd, Cardiff CF24 5HN, UK Tel +44 (0) 29 20485885 Fax +44 (0) 29 20492520 Email: [email protected]

INPUT RATING:

9V

Made in the U.K. 750316-2

3.5.1

1A

Connecting to Power Supply

Connect the power supply to the desk stand and connect to mains supply.

3.5.2

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Description

• • •

Battery charging LED status Red Amber Green

Battery conditioning Charging Charged

Set-Up

4.1

Battery Installation - MP1 1.

2.

Set-Up

4.

Slide the battery compartment latch across to remove the battery cover.

Install four “AA” size batteries, ensuring correct polarity.

3.

Replace the Battery cover before use.

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Set-Up

4.2

Battery Installation - MP1R

1.

Remove the securing screw and the battery cover.

2.

Install four “AA” size rechargeable batteries, ensuring correct polarity.

3.

Replace the Battery cover before use.

Caution: Use only the prescribed batteries with the system. Note:

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Do not mix alkaline “AA” batteries with rechargeable batteries. When replacing batteries, replace with four fresh batteries. Do not mix new and used batteries.

Probe Installation and Use Warning

Before use, carefully read the probe manufacturers directions for use, including all warnings, cautions, and instructions.

Warning

Do not use a damaged probe. Do not use a probe with exposed optical components.

Warning

Use only BCI sensors for SpO2 measurements. Other sensors may cause damage.

Warning

Incorrectly applied sensors may give inaccurate readings.

1.

Connect the probe to the pulse oximeter.

2.

Insert the patient’s finger into the tip of the oximeter probe.

3.

Ensure the cable extends along the top of the patient’s hand.

Set-Up

4.3

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Operation

5.

Operation

5.1

Switching the Unit ON Warning

Do not lift the unit by the probe cable.

Press the ON/OFF button

.

During power up, the system will perform a self test, illuminate the displays for 2 seconds and enter the measurement mode.

5.2

System Operation With the system connected to a patient, the oximeter will search for a pulse. After a short period the system will display the patient’s saturation level and pulse rate. The pulse indicator will be synchronised with the audible pulse tone (If enabled).

The frequency of the pulse tone is closely related with saturation level; lower tones indicate lower saturation levels. After 2 mins, the display will reduce to a level which is equivalent to 50% output intensity; press any key to re-establish the normal display intensity setting. The display will automatically brighten in the event of an alarm condition.

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Operation

If there is no finger connected to the sensor, the %SpO2 and Pulse Rate (♥/min) will display:

If no probe is connected to the system, the unit will turn off automatically after 3 minutes.

Warning

Reposition the probe at least once every 4 hours to allow the patient’s skin to respire.

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Operation

5.3

Setting the Alarms The default setting for the alarms are:• • • •

SpO2 Low SpO2 High HR Low HR High

Press the MENU

92% 99% 50BPM 150BPM button to enter the Alarm Setup mode.

The display will change to :

Press the UP

or DOWN

button to adjust the SpO2 low setting.

Press the MENU button to select the SpO2 high setting. Press the UP or DOWN button to adjust the SpO2 High setting. Press the MENU button to select the HR Low setting. Press UP or DOWN button to adjust the setting. Press the MENU button to select the HR High setting. Press the UP or DOWN button to adjust the setting. Press the MENU button to save the settings.

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Setting the pulse tone Press the MENU button five times to display the Pulse Tone set-up option. Press the UP or DOWN key to set the pulse tone Setting

Display

• OFF • ON

PB OFF PB ON

Operation

5.4

Press the MENU button to save the settings.

5.5

Pulse Strength Press and hold the UP button to display the Pulse Strength. The bar graph will illuminate according to the strength of the pulse signal.

Good Quality

5.6

Poor Quality

Switching the Unit OFF Press the ON/OFF

button to switch the unit OFF.

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Care of your Equipment

6.

Care of Your Equipment It is recommended that the unit and accessories are inspected and tested on a regular basis. If any part of the system appears to be damaged, the system should be returned to your service centre for repair.

6.1

Storage Remove the batteries from the unit before long-term storage.

6.2

Cleaning and Disinfecting Warning

6.2.1

Turn the Pulse Oximeter OFF before cleaning.

Care of the Sensor

Clean the probe after each use. Clean the surface of the sensor and cable with a soft gauze pad by saturating it with a solution of 70% isopropyl alcohol. If low level disinfection is required, use a 1:10 bleach solution.

6.2.2

Care of the Unit

If cleaning is required, wipe the Pulse Oximeter’s surfaces with a soft cloth moistened with a non-abrasive cleaner. Do not allow any liquid to enter any of the system.

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Specifications Electrical Power requirements MP1

4 x AA High Capacity Alkaline cells

MP1R

4 x AA rechargeable NiMH ≥ 2500mAH cells

Battery life MP1

60 hours typical

Battery life MP1R

60 hours typical before recharge is required

Specifications

7.

Charger MP1R only Type

Desk top stand with wall mount power supply

Charge time

6.5 Hours to full charge Built in protection for under / over charge

Wall cube

Input voltage 100 – 240 VAC 60Hz @ 6VA Output 9V

General Dimensions

75 x 140 x 25mm (excluding desk stand, sensor and wall cube)

Weight

300gm (excluding desk stand, sensor and wall cube)

Display indicators

• • • • •

Alarms

Audible and visual alarms for high and low saturation and pulse rate. Synchronized saturation tone

SpO2 Pulse rate Pulse Strength Alarm status Charge status (desk stand only)

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Specifications

Environmental Operating temperature

5°C to 40°C

Storage temperature

-40°C to +70°C

Humidity

5% to 95% non condensing

Pressure

600mbar – 1080mbar

SpO2 /Pulse Rate %Saturation Range

0 – 99% Functional SpO2 (1% increments)

Accuracy

Adults +/-2% @ 70 – 99% SpO2 < 70% undefined

Averaging

8 beats

Pulse Rate Range

30 – 254 BPM (1 BPM increments)

Accuracy

Better than +/-2 BPM or +/-2%

Averaging

8 seconds

Bargraph

0 – 8 segments providing pulsatile signal or pulse strength

Calibration

Factory calibrated over range 70% to 100%

Compliance Medical Electrical Equipment 25EA

Equipment classification

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IEC60601-1, WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY, IN ACCORDANCE WITH UL60601-1, CAN/CSA C22.2 No 601.1 and ISO 9919.

EMC compliance

EN55011 Group 1 Class B, EN60601-1-2, EN61000-3-2, EN61000-3-3

Degree of protection

Type BF

Degree of protection against ingress of water

IPX1

Trouble Shooting

Problem

Possible Cause

Corrective Action

Unit will not switch on

Depleted batteries

Replace batteries (MP1) Recharge batteries (MP1R)

Unit switches on but switches off after a short time when not connected to a patient.

Auto off set

Contact Service Dept. (See section 11).

Display goes DIM after a few minutes

Ad (Auto dim) set

Contact Service Dept. (See section 11).

No Fin displayed when connected to a patient.

Faulty sensor

Replace sensor

No Prb displayed when sensor connected

Faulty sensor

Replace sensor

Pulse rate erratic, intermittent or incorrect.

Sensor incorrectly positioned. Poor patient perfusion. Patient motion.

Reposition sensor on patient. Patient must be still for unit to function properly.

Charge lamp does not illuminate when unit placed on charger

Charger wall cube not connected to mains power or to the charger cradle.

Check power and connection.

Open circuit/ faulty batteries.

Check/ replace batteries.

Trouble Shooting

8.

Dirty charger/ MP1R contacts. Clean contacts. Faulty charger

Test by shorting charger contacts with metal object charge lamp should go RED.

Charge lamp illuminates and stays RED continuously.

Faulty batteries

Replace batteries

Batteries charge normally but unit runs only for a short time

Faulty batteries

Replace batteries

No bleep from MP1R when placed in charger cradle.

Batteries have insufficient charge. No power to charger Dirty charger contacts

Recharge batteries

MP1 / MP1R displays “Err”

Internal system error

Return to supplier for service

Connect power to charger. Clean contacts.

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