Ambu 492322000 Disposable Pressure Manometer User Manual
- June 12, 2024
- Ambu
Table of Contents
Ambu 492322000 Disposable Pressure Manometer
Product Information
The Ambu Disposable Pressure Manometer is a medical device designed for monitoring the airway pressure of patients. It isintended for use by medical professionals trained in airway management such as anesthesiologists, nurses, rescue personnel, and emergency personnel. The device can be used together with resuscitators, hyper-inflation bags, CPAP masks, or circuits.
The Ambu Disposable Pressure Manometer has the following specifications:
- Dimensions: Length – 55 mm (2.2″), Diameter – 22 mm (0.9″)
- Weight: Approximately 6.9 g
- Connector Port Dimensions: Inner diameter – 4.0 mm (0.16″), Maximum allowed dilated diameter – 4.3 mm (0.17″)
- Pressure Measuring Limits: Up to 902,000,000 G2/cm (902 T2/m)
- Pressure Measuring Accuracy: Meets EN ISO 10651-4 standards
- Storage Temperature Limits: Recommended long-term storage in closed packaging at room temperature, away from sunlight
- MR Conditional: Can be used inside the MR bore, but may influence MR image quality. RF-induced heating and MR image artifacts have not been tested. Any metallic parts are fully encapsulated and do not have any contact with the human body.
Product Usage Instructions
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Inspect the Ambu Disposable Pressure Manometer visually to ensure it is intact.
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Attach the Ambu Disposable Pressure Manometer to the desired device, such as a resuscitator or other compatible equipment.
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Before each use, visually inspect the device and perform a functionality test to check for defects or foreign matter that may affect pressure readouts.
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Do not use the product if the functionality test fails, as it may provide incorrect pressure readouts.
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Avoid using the Ambu Disposable Pressure Manometer if it is contaminated by external sources, as this can cause infection.
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Limit the usage of the Ambu Disposable Pressure Manometer to a maximum of 4 accumulated hours over a span of 1 week to minimize the risk of infection.
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Do not reuse the Ambu Disposable Pressure Manometer if visible moisture or residues are present inside the device, as this can lead to infection or malfunction.
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When using supplemental oxygen, ensure there is no smoking or use of the device near open flame, oil, grease, flammable chemicals, or equipment/tools that cause sparks to prevent fire or explosion.
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The Ambu Disposable Pressure Manometer is for single patient use only. Using it on multiple patients can cause cross infection.
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Do not soak, rinse, disinfect, or sterilize the device, as these procedures may leave harmful residues or cause malfunction.
The device is not compatible with conventional cleaning and sterilization procedures. -
Check the packaging for the expiration date and avoid using an expired device, as it may result in decreased performance or malfunction.
Important information
Read before use
Read these safety instructions carefully before using the Ambu® Disposable
Pressure Manometer.
The instructions for use may be updated without further notice. Copies of the
current version are available upon request. Please be aware that these
instructions do not explain or discuss clinical procedures. They describe only
the basic operation and precautions related to the operation of the manometer.
Before initial use of the Ambu Disposable Pressure Manometer, it is essential
for operators to have received sufficient training in resuscitation techniques
and to be familiar with the intended use, warnings, cautions, and indications
mentioned in these instructions.
There is no warranty on the Ambu Disposable
Pressure Manometer
-
Intended use
The Ambu Disposable Pressure Manometer is intended to be used for monitoring the patient’s airway pressure. -
Indications for use
The Ambu Disposable Pressure Manometer is indicated in situations where monitoring of the patient airway pressure during ventilation is needed. -
Intended patient population
Patients of all ages including adults, pediatric and infants requiring monitoring of the airway pressure during ventilation. -
Intended user
Medical professionals trained in airway management such as anesthesiologists, nurses, rescue personnel and emergency personnel. -
Contraindications None known.
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Clinical benefits
Use of the Ambu Disposable Pressure Manometer together with resuscitators, hyper-inflation bags, CPAP masks or circuits allows for monitoring of the patient’s airway pressure. -
Warnings and cautions
WARNINGS
- For single-patient use only. Use on other patients can cause cross infection.
- Only to be used by intended users who are familiar with the content of this manual, as incorrect use may harm the patient.
- Always visually inspect the Ambu Disposable
- Pressure Manometer and perform a functionality test after unpacking, assembly and prior to use, as defects and foreign matter can lead to wrong pressure readouts. 4. Do not use the product if test for functionality fails as this can lead to incorrect pressure readouts.
- Do not use the Ambu Disposable Pressure Manometer if contaminated by external sources, as this can cause infection.
- Do not use the Ambu Disposable Pressure Manometer for more than 4 accumulated hours over a maximum timespan of 1 week, in order to avoid the risk of infection.
- Do not reuse the Ambu Disposable Pressure Manometer if visible moisture or residues are left inside the device in order to avoid the risk of infection or malfunction.
- When using supplemental oxygen, do not allow smoking or use of device near open flame, oil, grease, other flammable chemicals or equipment and tools, which cause sparks, due to the risk of fire and/or explosion.
CAUTIONS
- Do not soak, rinse, disinfect or sterilize this device as these procedures may leave harmful residues or cause malfunction of the device. The design and material used are not compatible with conventional cleaning and sterilization procedures.
- Please see packaging for more specific information about the expiration date, as the use of an expired device might lead to decreased performance or malfunction of the product.
General notes
- If, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority.
Device description
The Ambu Disposable Pressure Manometer is non-sterile and for single patient,
multiple use. It is intended to be used for monitoring the patient’s airway
pressure in the range from 5 – 60 cmH₂O.
The Ambu Disposable Pressure Manometer is suitable for use with Ambu
resuscitators or other resuscitators, hyperinflation bags, CPAP masks or
circuits, as described in section 4.2 and 4.3.
Explanation of symbols used
A full list of symbol explanations can be found on ambu.com/symbol- explanation.
Product use
Inspection and preparation
- Visually inspect the Ambu Disposable Pressure Manometer to verify it is intact.
- Attach the Ambu Disposable Pressure Manometer with its flexible connector port by removing the cap from the manometer port of the breathing device and pressing the two products together to secure the connection.
- Perform functional testing:
- Occlude the patient connection port of the attached breathing device while operating it and confirm that the manometer piston moves to its maximum position.
- Release the pressure and check that the piston returns smoothly back below the “5” cmH₂O reading.
Operating the Ambu Disposable Pressure Manometer
- Following inspection, attachment and functional testing (section 4.1, step 3) the Ambu Disposable Pressure Manometer is ready for use.
- The patient airway pressure can be read from the position of the black piston ring relative to the value scale on the manometer housing.
- If removing the Ambu Disposable Pressure
Manometer during ventilation, remember to replace the cap on the manometer port on the breathing device.
Compatibility requirements when connecting Ambu Disposable Pressure
Manometer to third party breathing devices:
Manometer connector dimensions for fit with third party breathing devices:
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Hole dimension of manometer connector port: diameter Ø 4.0 mm.
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Allowable deformation of the flexible manometer connector port applied by third party breathing device connector: up to Ø 4.3 mm.
Pre-test of compatibility with third party breathing devices: -
Manometer shall not separate from third party breathing device when performing functional testing as described in section 4.1 (step 3).
After use
Used products must be disposed of according to local procedures.
Technical product specifications
Specifications
Dimensions (approx.)| Length 55 mm (2.2”)
Diameter 22 mm (0.9”)
---|---
Weight (approx.)| 6.9 g
Connector port dimensions| Inner diameter 4.0 mm (0.16”) Maximum allowed
dilated diameter 4.3 mm (0.17”)
Pressure measuring limits|
5 – 60 cmH₂O (hPa)
Pressure measuring accuracy| ± 2 cmH₂O (hPa) at 5, 10, 15, 20
and 30 cmH₂O (hPa)
± 3 cmH₂O (hPa) at 40 cmH₂O (hPa)
± 5 cmH₂O (hPa) at 60 cmH₂O (hPa)
Operation temperature limits| -18 °C to +50 °C
(-0.4 °F to +122 °F) according to EN ISO 10651-4
Storage temperature limits| -40 °C to +60 °C (-40 °F to +140 °F)
according to EN ISO 10651-4
Recommended long term storage in closed packaging at room temperature, away from sunlight
MRI Safety information
The Ambu Disposable Pressure Manometer is tested to be MR Conditional and
therefore may be safely used in the MR environment (not inside the MR bore)
under the following conditions.
- Static magnetic field of 7 Tesla and less, with
- Maximum spatial field gradient of 20,000 G/cm (200 T/m)
- Maximum force product of 902,000,000 G2 /cm (902 T2 /m)
Use inside the MR bore may influence
MR image quality.
RF-induced heating and MR image artifacts have not been tested. Any metallic
parts are fully encapsulated and do not have any contact with the human body
Ambu A/S
Baltorpbakken 13
2750 Ballerup
Denmark
T +45 72 25 20 00
ambu.com
Ambu® is a registered trademark of Ambu A/S, Denmark.
Ambu A/S is certified according to ISO 13485.
492 3220 00 – V06 – 2022/05 – Ambu A/S, Denmark. TCC 11151
References
- Ambu - Single-use devices that save lives
- Ambu - Single-use devices that save lives
- ambu.com/symbol-explanation