WiZARD 510 Nasal Mask User Manual

WiZARD
510 Nasal Mask
User Manual

WARNING

1. This mask is not suitable for providing life support ventilation.
2. Use your mask as prescribed by your physician.
3. The vent holes associated with the mask should never be blocked for proper exhaling purposes.
4. Do not block or seal exhalation ports. Occlusion of the exhaust needs to be prevented to avoid having an adverse effect on the safety and quality of the therapy.
5. At low CPAP pressure, some exhaled gas may remain in the mask and be re-breathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation.
6. Some users may have skin redness, irritation, discomfort or other adverse reactions. If this happens, discontinue to use and contact your health care professional.
7. It should be used only together with the appropriate flow generator equipment (CPAP or bi-level system) to ensure optimum therapy.
8. Ensure the device is generating airflow before the oxygen supply is turned on. Always turn off the oxygen supply before stopping the airflow from the device. Explanation of the Warning: When the device is not in operation and the oxygen flow is left on, oxygen delivered into the tubing may accumulate within the device’s enclosure and create a risk of fire.
9. Do not wear this mask unless the CPAP or bi-level device is turned on. Explanation of the Warning: CPAP and bi-level devices are intended to be used with special masks (or connectors) which have vent holes to allow a continuous flow of air out of the mask. When the device is turned on and functioning properly, fresh air from the device flushes the exhaled air out through the vent holes on the mask. However, when the device is not operating, fresh air provided through the mask will not be enough, and the exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can, in some circumstances, lead to suffocation. This applies to most models of CPAP or bi-level devices.
10. This mask should not be used on patients who are uncooperative or taking drugs that may cause vomiting.
11. Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If any symptom occurs,  consult your physician or dentist.
12. Do not overtighten the headgear straps.
13. The medical devices which are not intended to be combined with the mask can decrease the safety or alter the performance of the mask.

Introduction

This manual should be used for the initial set-up of the system and saved for reference purposes.

Intended Use
The Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The Mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. The Mask is to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.

NOTE: An exhalation port is built-in into this mask so a separate exhalation port is not required. US Federal law restricts this  device to sale by or on the order of a physician

Contraindications
This mask is not for use on patients with the following conditions: recent eye surgery or dry eyes, hiatal hernia, excessive reflux,  impaired cough reflex, and impaired cardiac sphincter function. This mask is not for use on patients who are dependent on mechanical ventilation for their life support. This mask is not for use on a patient who is taking a prescription drug that induces vomiting, or on patients who are uncooperative, unresponsive, or unable to remove the mask by themselves. This mask should not be placed over open wounds or skin at risk of decubitus ulcers that are susceptible to infection.

Product Descriptions

Unpacking the Contents
Components include:
(1) Mask with Headgear (2) User manual
Unpack this box by removing the sticker and check the mask for any damage, which may have occurred during shipping. If there are damages, please contact your dealer immediately.
Mask Overview

1. Headgear
2. Mask Cushion
3. Mask Frame
4. Elbow with Exhalation Ports (Keep clear)
5. Flexible tube
6. Quick Release with Push Button
7. Swivel

Before Use

• Read the instructions completely
• Hand wash the mask
• Inspect the mask and replace it if the cushion silicone side it hardened or if any parts are broken.

Use your Mask

• Remove one of the headgear clips on the fabric frame. Hold the mask with the cushion over the nose and across the headgear over the head.
• Hook the headgear clips on the mask frame and avoid the fabric frame touching the bottom of your eyes.
• Adjust upper headgear straps to a comfortable fit. The cushion should lightly touch the face.
• Adjust lower headgear straps to a comfortable fit. The lower straps should be kept below the ears.
• Connect the tubing to your flow generator (CPAP or bi-level devices) and turn on the airflow.
• Adjust the headgear to prevent any leaks from the cushion without over-tightening the straps.

Note: Always read the operating instructions before use.

Cleaning Your Mask at Home

• Daily clean mask without headgear and weekly wash headgear after each use
• Unhook both headgear clips from the mask frame. It is not necessary to remove the headgear clips from the headgear.
• Hand washes mask and headgear in warm water (approximately 30℃/86℉) using mild soap or diluted dishwashing detergent. All facial oils should be removed from the mask
• Use a soft bristle brush to clean the expiratory port.
• Rinse all parts of the mask thoroughly with drinking quality water.
• Air dry completely before use. Lay the headgear flat or line dry.

CAUTION: Do not place the headgear into the dryer.
CAUTION: Do not use bleach, chlorine, alcohol, scented oils, or aromatic- based solutions. These solutions may damage the mask, cause cracks and reduce the life of the product. Do not iron the headgear.

Reprocessing the Mask Between Patients (Multi-Patient Use)
Refer to Annex A Disinfection Guide for Professional Users to reprocess between patients in a clinical setting.

Assembling the Mask

• Push the cushion into the frame. The frame has a shape that allows you to insert the cushion only one way.
• Place the headgear with the APEX logo outside and upright, thread the upper and lower headgear straps into the bilateral fabric frame slots from the inside and ensure the Velcro and headgear clips are outside. Fold them over to secure.
• Hook the headgear clips on the mask frame
• Push the quick-release button then connect the swivel

CAUTION: Please check the part number before reassembling the mask after cleaning.

Technical Specifications

Note: The mask system does not contain latex, PVC, or DEHP materials.
Exhaust Flow
The mask has vent holes to protect against rebreathing.

The mask has vent holes to protect against rebreathing.

Pressure (cm H2O)| 4 8 12 16 20 24 28 30
Flow (L/Min)| 20 29 37 43 49 54 59 61
Mask Dead Space
M  75.3 ml|  L  93.6 ml
Therapy Pressure Range
4-30 cm H2O
Resistance (pressure drop)
at 50 l/min: 0.4 cm H2O| at 100 l/min: 1.5cmH2O
Sound Level
≦26 dBA (with CAPA and humidifier ) / ≦28 dBA (with CPAP)
(Pressure setting 10cmH2O, at 1-meter position)
Operating Range
5°C to +35°C (+41°F to +95°F)
15% to 95% relative humidity  non-condensing
Storage and Transport
15°C to +60°C (+5°F to +140°F)
10% to 90% relative humidity  non-condensing
Store the mask in a dry place out of direct sunlight.
Disposal
Dispose of in accordance with local regulations.
Expected Design Life (After Unpacking)
6 months

Symbols

| Caution| | Temperature limitation
---|---|---|---
| Consult instructions for use| | Humidity limitation
| Reference Number| | Not made with natural rubber latex
| Lot Number| | Prescription-only (In the US, Federal law restricts these devices to sale by or on the order of a physician.)
| Use by| | Manufacturer
| Date of manufacture| | Authorized European representative

NOTE, CAUTION, AND WARNING STATEMENTS

NOTE: Indicates information that you should pay special attention to.
CAUTION : Indicates correct operating or maintenance procedures in order to prevent damage to or destruction of the equipment or other property.
WARNING : Calls attention to a potential danger that requires correct procedures or practices in order to prevent personal injury.

Limited Warranty

Apex Medical Corp. (hereafter ‘Apex’) gives the customer a limited manufacturer warranty on new original Apex products and any replacement part fitted by Apex in accordance with the warranty conditions applicable to the product in question and in accordance with the warranty periods from the date of purchase as listed below. This warranty does not cover damage caused by accident, misuse, abuse, alteration, and other defects not related to material or workmanship. To exercise your rights under this warranty, please contact your local, authorized Apex dealer.
NOTE: Warranty is only valid in the country of purchase.

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