KnightStar 330 User Manual Rev A

© Copyright 2006 Nellcor Puritan Bennett Inc. All rights reserved. KnightStar® and Bi-Level® are registered trademarks of Nellcor Puritan Bennett Inc. For more information, contact your Puritan Bennett representative. The ventilator should be operated and serviced only by trained professionals. Puritan Bennett’s sole responsibility with respect to the ventilator, and its use, is as stated in the limited warranty provided. Nothing in this manual shall limit or restrict in any way Puritan Bennett’s right to revise or otherwise change or modify the equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the contrary, Puritan Bennett has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its software) described herein.

Manufacturer: Puritan-Bennett Corporation 4280 Hacienda Drive Pleasanton, CA 94588 USA Toll Free: 1.800.635.5267

Authorized Representative: Tyco Healthcare UK Limited 154 Fareham Road Gosport PO13 0AS, U.K.

Contents 1 Introduction

1-1

1.1 Warnings, Cautions, and Notes... 1-2 1.2 System controls and indicators... 1-8 1.3 KnightStar 330 connectors... 1-12 1.4 KnightStar 330 symbols... 1-14 1.4.1 Bottom panel label symbols... 1-14 1.4.2 Onscreen symbols... 1-17

2 Getting started

2-1

2.1 KnightStar 330 system and components... 2-2 2.2 System setup... 2-4 2.2.1 Before first use... 2-4 2.2.2 How to connect to AC power... 2-4 2.2.3 How to connect the breathing circuit, outlet filter, and mask... 2-5

3 How to operate the KnightStar 330

3-1

3.1 Basic operation... 3-1 3.1.1 How to set the Delay/Ramp... 3-2 3.1.2 How to de-activate and activate the Delay/Ramp feature... 3-4 3.2 How to use the KnightStar 330 with supplemental oxygen... 3-5 3.3 How to use the optional humidifier... 3-7 3.4 How to use the KnightStar 330 with an external battery... 3-10 3.5 How to clean the KnightStar 330... 3-11 3.5.1 How to clean the breathing circuit... 3-11 3.5.2 How to clean the exterior surfaces... 3-12 3.5.3 How to clean the inlet air filter... 3-12 3.5.4 How to replace the outlet filter... 3-13 3.6 Periodic maintenance... 3-14

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Contents 4 How to solve device problems

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5 Patient and caregiver information

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6 EMC information

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6.1 Manufacturer’s Declaration... 6-1

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CHAPTER 1

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Introduction

The Puritan Bennett KnightStar® 330 Bi-Level® Ventilator assists patients who are being treated for respiratory insufficiency or Obstructive Sleep Apnea (OSA) in the home, hospital, or institutional setting. It is also used to treat respiratory failure in the hospital setting. The KnightStar 330 is designed to prevent the upper airway from being obstructed by delivering air pressure through an interface (mask or nasal pillows) using one of three different modes; Inspiratory/Expiratory Positive Airway Pressure (I/E PAP), Assist Control (A/C), or Continuous Positive Airway Pressure (CPAP). I/E PAP mode allows you to breathe at separate inspiratory and expiratory pressure levels, while CPAP mode provides a single, continuous breathing pressure. These pressure levels are set by your clinician so that they provide enough pressure to keep the airway open while maintaining a comfortable breathing effort while you sleep. A/C mode ventilates patients just as I/E PAP mode with the additional features of a settable backup ventilation respiratory rate and I:E ratio. Patients using the KnightStar 330 should weigh at least 30 kg (66 lbs) and be able to breathe on their own. Read this entire booklet before using the KnightStar 330. It will help you use the device safely and effectively. If you have any questions about the device or its use, contact your physician or home care provider.

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1.1 Warnings, Cautions, and Notes The following words and symbols found in this manual have special significance: Warnings alert the user to potential serious outcomes (death, injury, or adverse events) to the patient or user.

Cautions alert the user to exercise care necessary for the safe and effective use of the KnightStar 330.

Notes indicate information of particular interest for more efficient and convenient operation.

Review the following messages prior to using the KnightStar 330: When using this equipment, it is important that you read, understand, and follow the instructions and warnings in this user’s manual.

There is no audible alarm built into the KnightStar 330 to indicate that the patient has stopped breathing.

Under certain conditions, some alarms may not occur. For example: (1) the leak alarm may not occur if patient breath efforts are not detected, as in the case of excessively large leaks; and (2) the low pressure alarm may not occur under conditions such as an incorrect alarm threshold setting or air pathway resistance.

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This product is intended for use only as prescribed by a physician.

The KnightStar 330 and all other bi-level pressure devices should only be used with interfaces and breathing circuits recommended by the device’s manufacturer or by your physician.

An interface should not be used unless the device is turned on and operating properly. When the device is turned on and functioning properly, fresh air from the device flushes the exhaled air out through the interface vent hole(s). However, when the device is not operating, a substantial proportion of exhaled air, including carbon dioxide (CO2) may be rebreathed. Prolonged rebreathing of carbon dioxide can increase CO2 levels and, in some circumstances, may even result in death. DO NOT BLOCK THE INTERFACE VENT HOLE(S).

At low pressure settings, the flow through the vent hole may be inadequate to clear all exhaled air from the tubing. Some rebreathing may occur.

For your health and comfort, clean the KnightStar 330, interface, and breathing circuit regularly before use. Refer to Section 3.5, on page 3-11, or follow the cleaning instructions that came with your interface and breathing circuit.

Set up the KnightStar 330 system as shown in this manual for safe and effective operation.

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To reduce the risk of strangulation, be sure to route the tubing away from the head.

Keep the breathing circuit and power cord away from heated surfaces.

Patients who receive supplemental oxygen should be aware that hazards exist with combustible materials and flames or sparks in the presence of oxygen. Do not smoke in the presence of oxygen.

At a fixed flow rate of supplemental oxygen, the inhaled oxygen concentration will vary depending upon pressure settings, patient breathing patterns, mask or nasal interface selection, and leak rate.

Explosion Hazard – This equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air, or with oxygen or nitrous oxide.

The KnightStar 330 should never be operated where gases from external sources, gas stoves, engine exhaust, or anesthesia machines could be combined with air at the inlet. Placing the unit in such an area may result in asphyxiation.

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To avoid electrical shock: • Do not use if power cord or plug is damaged • Unplug all power cords before cleaning • Do not use near water such as sinks, showers or bathtubs, where water could spill onto the device • If you suspect that water has entered the KnightStar 330, unplug the power cord and let device dry before using

Never drop or insert any object into the air outlet or any other opening on the unit or breathing circuit.

Should you experience nasal or airway dryness, skin sensitivity, runny nose, ear pain, sinus discomfort, daytime sleepiness, mood change, disorientation, or memory lapse when using this device, discontinue use and call your physician.

Contact your home care company if the equipment malfunctions in any way. Do not attempt to open the device case. Only qualified personnel may service this equipment.

If the display indicators on the unit are inoperative, the unit must be checked by the proper personnel.

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Always place the KnightStar 330 upright on a firm, flat surface, and use only approved accessories. Placing the device on uneven surfaces, using it in an improper orientation, or using unapproved accessories could result in the device tipping over, causing damage or possible patient injury.

The KnightStar 330 should be used with care to avoid overheating the patient when the room temperature exceeds 32.2 oC (90oF), since under certain conditions the patient outlet gas flow can be as much as 3.7oC (6.7oF) degrees warmer than room temperature.

The KnightStar 330 equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2:2001 (or EN 60601-1-2:2001 or Medical Device Directive 93/42/EEC). This testing shows the device provides reasonable protection against harmful interference in a typical medical installation. However, there is no guarantee that interference will not occur in a particular installation, for example, in the presence of portable and mobile RF communication devices. If this equipment does cause harmful interference to other devices or is negatively impacted by other devices, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the devices • Increase the separation between the devices • Connect the equipment to an outlet on a different circuit • Consult the manufacturer or field service technician for help

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Do not set the KnightStar 330 on or within 3 feet (1 m) of electric or electronic appliances, such as space heaters, electric blankets, or televisions. Do not operate cordless phones near the device. Doing so may result in device malfunction.

Be careful when handling the KnightStar 330 during or immediately after use. Under specified operating conditions, some surfaces of the unit may become hot to the touch. This is a normal occurrence and is typical of this type of device.

Always operate the KnightStar 330 with the outlet filter in place. Failure to do so could increase your risk of infection or contaminant inhalation.

Inspect the inlet air filter often. Remove the foam filter from the rear panel and clean it at least once per week, or more often in dusty environments. Let the filter air dry completely before reinstallation. See Section 3.5.3 on page 3-12 for information on cleaning the inlet air filter.

Start the KnightStar 330 system before putting on the interface.

Federal (USA) law restricts this device to sale by or on the order of a physician.

At the end of the KnightStar 330's useful life, return the device to the manufacturer for proper disposal.

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1.2 System controls and indicators The following sections help you to become familiar with the KnightStar 330 control panel and indicators, and describe the various symbols displayed on the device’s labels and LCD screen. The KnightStar 330 control panel keys and indicators are shown in Figure 1-1 and described in Table 1-1.

PURITAN BENNETT TM

Bi-Level âVentilator

10

1

2

1 2 3

3 4 5

6 7

8

9

Figure 1-1. KnightStar 330 control panel

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Table 1-1: KnightStar 330 control panel keys and indicators Key or indicator (Figure 1-1)

Labeling

1

Function Access mode indicator. Indicates the KnightStar 330 is in Patient access mode. Indicates the KnightStar 330 is in Clinician access mode. Patient access mode prevents accidental changes to the settings prescribed by your physician, and allows you to change the delay time, ramp duration, and ramp start pressure. Clinician access mode allows your physician to program the prescribed breathing mode, pressure(s), and other settings into the device.

2

Mode key. 1 2 3

3

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Press the Mode key to leave the Settings mode after changing the delay time, ramp duration, or ramp start pressure settings. Pressing this key also turns on the LCD panel backlight. In Clinician access mode, the Mode key is used to set the breathing mode to A/C, CPAP, or I/E PAP. Settings key. Press the Settings key repeatedly to enter the Settings mode and scroll through the delay time, ramp duration, and ramp start pressure options (shown on the LCD panel as , , and ). P Pressing this key also turns on the LCD panel backlight.

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Table 1-1: KnightStar 330 control panel keys and indicators (continued) Key or indicator (Figure 1-1)

Labeling

Function

4

Down Arrow & Delay/Ramp key. Use the Down Arrow key to decrease a selected setting value when setting the delay time, ramp duration, or start pressure. If not in Settings mode, use this key to start or stop the Delay/Ramp function. The symbol appears in the lower left corner of the LCD panel when the delay/ramp function is active.

5

Up Arrow & Alarm Silence key. Use the Up Arrow key to increase a selected setting value in Settings mode. If not in Settings mode, use this key to mute an active alarm for one minute. In I/E mode, when the main display screen is shown, pressing this key displays V (peak inhalation flow) and I:E ratio (ratio of inhalation time to exhalation time) if there are no active alarms.

6

7

On/Off key. Turn the KnightStar 330 system on with a quick press and release action. To turn the device off, press and hold the On/Off key for 3 seconds. The KnightStar 330 retains in memory the settings last entered. Green LED

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When lit, indicates the presence of power, whether from Mains/AC or external battery (Stand-by mode).

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Table 1-1: KnightStar 330 control panel keys and indicators (continued) Key or indicator (Figure 1-1)

Labeling

Function

8

Yellow LED

When steadily lit and accompanied by the f symbol displayed in the lower left corner of the LCD panel, indicates a LOW PRIORITY alarm condition. When flashing, indicates a MEDIUM PRIORITY alarm condition accompanied by an audible alarm signal (3 beeps at intervals of approximately 25 seconds). Refer to Chapter 4 for causes and corrections for alarm conditions.

9

Red LED

When flashing, indicates a HIGH PRIORITY alarm condition accompanied by an audible alarm signal (a series of 3 beeps, then 5 beeps, then 2 beeps at intervals of approximately 6 seconds). Refer to Chapter 4 for causes and corrections for alarm conditions.

10

Liquid Crystal Display (LCD)

The LCD provides an easy-to-read format for mode, settings, and patient data. A backlight illuminates the display when the Mode, Settings, or Up arrow key is pressed. The display will remain lit for approximately 60 seconds after the last key is pressed.

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1.3 KnightStar 330 connectors Figures 1-2 and 1-3 and Tables 1-2 and 1-3 identify and describe the connectors and their identifying symbols found on the KnightStar 330.

1 2 3

Figure 1-2. KnightStar 330 rear view

Table 1-2: KnightStar 330 rear panel connectors Index (Figure 1-2)

Symbol or label

1

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Description Mains/AC power receptacle. The KnightStar 330 operates on 100V to 240 V AC at 50 or 60 Hz.

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Table 1-2: KnightStar 330 rear panel connectors (continued) Index (Figure 1-2)

Symbol or label

Description

2

RS-232 (serial) port. This connector is used for communications with other devices such as a personal computer (PC).

3

External battery connector. Used to connect an optional external 12 V DC battery, or for use with a 12 V automobile cigarette lighter adapter when Mains/AC power is not available.

1

2

7 3 4

6 5

Figure 1-3. KnightStar 330 front and side view

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Table 1-3: KnightStar 330 front panel connectors and labeling Index (Figure 1-3) 1

Labeling

Description

Troubleshooting label

Contains information on how to respond to some alarms.

2

Refer to manual for information on using the ventilator with oxygen.

3

N/A

4

Air outlet connector (22 mm conical fitting).

5

N/A

6

7

Patient pressure tube connector.

Alarm speaker. Notifies user to refer to the manual (page 1-6) regarding increased outlet gas flow temperature.

Warning label

Warns user that surfaces can become hot to the touch.

1.4 KnightStar 330 symbols 1.4.1 Bottom panel label symbols Figure 1-4 and Table 1-4 describe the symbols found on the KnightStar 330’s bottom panel label.

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7 6

8

5 9 10 1

2

3

4

Figure 1-4. KnightStar 330 bottom panel label

Table 1-4: KnightStar 330 bottom panel label symbols Index (Figure 1-4)

Labeling

Description

1

Class II equipment. A regulatory standard classification for protection against electric shock. Class II equipment relies on DOUBLE INSULATION rather than protective earthing.

2

Type BF equipment. A regulatory standard classification for protection against electrical shock for the part of the device that contacts the patient.

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Table 1-4: KnightStar 330 bottom panel label symbols (continued) Index (Figure 1-4)

Labeling

3

4

Description Drip proof. A regulatory standard classification for protection against dripping water.

!

Attention! Consult accompanying documents.

5

Direct current (battery power).

6

This device complies with the requirements of Medical Device Directive 93/42/EEC concerning medical devices.

7

Alternating current (Mains/AC power from wall outlet).

8

Authorized to bear the CSA certification mark, signifying the product has been evaluated to the applicable CSA standards for use in the US and Canada. UL2601-1 CAN/CSA C22.2 No. 601.1- M90

9

SN

Serial number.

10

REF

Model number.

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