Ambu SPUR II Disposable Resuscitator Instructions
- June 9, 2024
- Ambu
Table of Contents
SPUR II Disposable Resuscitator
Instructions
Instructions for use
Ambu® SPUR® II
cSPUR II Disposable Resuscitator
Symbol Indication|
---|---
| Adult
| Pediatric
| Infant
| This product is not made with natural rubber latex nor phthalates
| Magnetic Resonance Conditional. Static magnetic field of 3-Tesla or less.
Spatial gradient magnetic field of 720-Gauss/cm or less.
Intended use
The Ambu® SPUR® II resuscitator is a single patient use resuscitator intended
for pulmonary resuscitation.
The range of application for each version is:
– Adult: Adults and children with a body weight more than 30 kg (66 lbs).
– Paediatric: Infants and Children with a body weights up to 30 kg (66 lbs).
– Infant: Neonates and infant with a body weight up to 10kg (22 lbs).
Warning and caution statements
Failure to observe these precautions may result in inefficient ventilation of
the patient or damage to the equipment.
WARNING
Oil or grease should not be used in close proximity to oxygen equipment. Do
not smoke or use open flame when oxygen is in use – fire may result.
Never override the pressure-limiting valve (if available) unless medical and
professional assessment indicates the necessity. High ventilation pressures
may cause lung rupture
to certain patients. If the pressure-limiting valve is overridden in patients
with a bodyweight less than 10 kg (22 lbs.), a manometer must be used to
monitor the ventilation pressure to avoid the possibility of a lung rupture.
By adding accessories, it may increase inspiratory and/or expiratory
resistance. Do not attach accessories if increased breathing resistance would
be detrimental for the patient.
CAUTION
US federal law restricts this device to sale by or on the order of a physician
(USA and Canada only)
For use by trained personnel only. The proper application of a facemask to
obtain tight seal should be trained in particular. Make sure that the
personnel are made familiar with the content of this manual.
Always inspect the resuscitator and perform a functional test after unpacking,
cleaning, assembly and prior to use.
Always watch the movement of the chest and listen for the expiratory flow from
the valve in order to check the ventilation efficiency. Switch immediately to
mouth-tomouth ventilation if efficient ventilation cannot be obtained.
Insufficient, reduced, or no airflow may result in brain damage to the patient
being ventilated. Do not use the resuscitator in toxic or hazardous
atmosphere.
For single patient use only. Use on other patients can cause cross infection.
Do not soak, rinse, 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.
Never store the resuscitator in a deformed state other than as folded when
delivered by the manufacturer, otherwise permanent distortion of the bag will
occur which may reduce the ventilation efficiency. The folding zone is clearly
visible on the bag (only Adult and Paediatric versions may be folded).
Specifications
The Ambu SPUR II resuscitator is in conformity with the product specific standard EN ISO 10651-4. The Ambu SPUR II is in conformity with Council Directive 93/42/EEC concerning Medical Devices.
| Infant| Paediatric| Adult
---|---|---|---
Stroke volume one hand| 150 ml| 450 ml| 600 ml
Stroke volume two hands| | | 1000 ml
Dimensions (length x diameter)| 168)(71 mm| 234 x 99 mm| 295 x 127 mm
Weight, incl. Reservoir and mask:| 140 g| 215 g| 314 g
Pressure-limiting valve*| 4.0 kPa (40 cm H2O)| 4.0 kPa (40 cm H2O)| 4.0 kPa
(40 cm H2O)
Dead space| < 6 ml| < 6 ml| < 6 ml
Inspiratory resistance*| max. 0.10 kPa
(1.0 cm H2O)
at 50 l/min| max. 0.50 kPa
(5.0 cm H2O)
at 50 l/min| max. 0.50 kPa
(5.0 cm H2O)
at 50 l/min
Expiratory resistance| 0.2 kPa (2.0 cm H2O)
at 50 l/min| 0.27 kPa (2.7 cm H2O)
at 50 l/min| 0.27 kPa (2.7 cm H2O)
at 50 l/min
Reservoir volume| 300 ml (bag)
100 ml (tube)| 2600 ml| 2600 ml**
Patient connector| Outside 22 mm male (ISO 5356-1)
Inside 15 mm female (ISO 5356-1)
Expiration connector (for PEEP valve attachment)| 30 mm male (ISO 5356-1)
Manometer Port connector| 0 4,2 +/- 0,1 mm
Demand Valve Connector| Inside 32 mm female (ISO 10651-4)
Forward and backward leakage| Not measurable
M-Port| Standard Luer LS 6
02 inlet connector| according to EN 13544-2
Operation temperature| -18°C to +50°C
Storage temperature| Tested at -40°C and +60°C
according to EN ISO 10651-4
Long term storage| For long term storage the resuscitator should be kept in
closed packaging in a cool place away from sunlight.
- Higher delivery pressure can be obtained by overriding the pressure-limiting valve.
** Also available with pressure limiting valve and manometer port.
*** The SPUR II can be delivered with inspiratory or expiratory filters by Ambu that have been tested to perform within the requirements of the ISO standard. The use of PEEP valves naturally increases the expiratory resistance above the limit in the ISO standard.
Principle in operation 1
The illustration (1) shows the ventilation gas flow mixtures into the bag and
to and from the patient during manual operation of the resuscitator. (a) Adult
and paediatric resuscitator, (b) infant resuscitator with closed reservoir,
(c) infant resuscitator with open reservoir. The gas flow is similar when the
patient is breathing spontaneously through the device. The O2 reservoir
assembly is fitted with two valves, one allowing mbient air to be drawn in
when the reservoir is empty and one spilling out surplus
oxygen when the reservoir bag is full.
1.1 Excess oxygen, 1.2 Air, 1.3 Oxygen inlet, 1.4 Patient, 1.5 Expiration, 1.6
Manometer port, 1.7 Pressure limiting valve, 1.8 M-Port
The M-Port provides access to the inspiratory and expiratory gas flow allowing
to connect a syringe for drug delivery (d) or to connect a gas sampling line
for measuring sidestream EtCO2 (e).
Instructions for use
5.1 Resuscitator 2
CAUTION
The O2 reservoir bag on the Adult and Paediatric resuscitators are permanently
attached to the inlet valve assembly. Do not attempt to disassemble. Do not
pull as tearing may occur. For the infant resuscitator, do not attempt to
disassemble the reservoir bag attachment by pulling the bag as tearing may
occur.
Preperation
– If the resuscitator is packed in a compressed state, unfold by pulling on
the patient valve and the inlet valve.
– If the facemask supplied with the resuscitator is wrapped in a protective
pouch, the pouch should be remove before use.
– Fit the facemask and place all items in the plastic bag supplied with the
resuscitator.
– The integrity of the kits issued for storage ready for use should be
inspected at the interval established in the local protocol.
– Before use on the patient make a brief functional test as described in
section 7.
Patient use
– Clear the patient’s mouth and airway using recommended techniques. Use
recommended techniques to position the patient correctly to open the airway
and to hold the mask firmly against the face. (2.1) – Slide you hand (Adult
Version) or ring and middle finger (Paediatric version) under the support
strap. The infant version does not have a upport strap. Ventilation without
using the support strap can be achieved by turning the bag. (2.2)
– Ventilate the patient. During insufflation observe the rise of the patient’s
chest. Release the bag abruptly and listen for the expiratory flow from the
patient valve and observe lowering of the chest.
– If continued resistance to insufflation is encountered, check the airway for
obstruction or correct the backward tilt of the head.
– If the patient vomits during mask ventilation, immediately clear the
patient’s airway and then freely compress the bag a few times before resuming
ventilation. If necessary wipe off the product with a swab containing alcohol
and clean the splash guard with tap water.
5.2 Manometer port 3
WARNING
Use only for monitoring pressure. The cap must always be put on the connector
when pressure is not being monitored.
A pressure gauge can be connected to the manometer port on the top of the
patient valve. (This only applies to the version with manometer port).
Remove the cap (3.1) and connect pressure manometer or the tube for the
pressure gauge (3.2).
5.3 Pressure limitation system 4
WARNING
Never override the pressure-limiting valve (if available) unless medical and
professional assessment indicates the necessity.
High ventilation pressures may cause lung rupture to certain patients. If the
pressure-limiting valve is overridden in patients with a bodyweight less than
10 kg (22 lbs.), a manometer must be used to monitor the ventilation pressure
to avoid the possibility of a lung rupture.
If the resuscitator is equipped with a pressure limiting valve, the valve is
set to open at 40 cm H2 O (4.0kPa) (4.1).
If medical and professional assessment indicates a pressure above 40 cm H2 O
is required pressure limiting valve can be overwritten by pressing the
override clip onto the valve (4.2). Alternatively the pressure limiting valve
can be overwritten by placing the index finger on the red button while
squeezing the bag.
5.4 M-Port
The SPUR II comes either with or without M-Port.
WARNING
Use the M-Port only for one of the two; EtCO2 measuring or drug
administration, as one can negatively impact the other.
The M-Port should not be used for side-stream EtCO2 monitoring of patients,
ventilated with less than 400 ml Tidal Volume.
When the M-port is not in use for either drug administration or connected to
an EtCO2
– measuring device the M-port must be closed by the cap to avoid excessive
leakage from the patient housing.
Do not attach oxygen supply tubing to the M-port.
To ensure proper delivery of the entire dosage, the M-port must be flushed
after each use.
If application of M-Port is required, do not use filter, CO2 detector or any
other accessories between the patient inspiratory port and the mask or ET tube
unless you use the optional adapter with syringe port to bypass filter/CO2
detector/accessories to deliver medication.
Measuring EtCO2
For measuring of side stream EtCO2 ; connect the gas-sampling line for the
EtCO2 measuring device to the M-Port of SPUR II. Lock the gas sampling line
connector by turning it 1/4 turn clockwise.
Applying medication
Carefully observe patient response to the administered medication.
Administration of volumes of 1 ml fluid or above through the M-Port is
comparable with administration directly into an endotracheal tube.
The M-Port has been tested with epinephrine, lidocaine and atropine.
CAUTION
An increase in the variation of the dosage of medication actually delivered
must be expected when administering volumes below 1 ml fluid and without
subsequent
flushing with appropriate fluid.
Consult your medical director for proper dosing guidelines.
Change to injection directly in the tube if unusually high flow resistance is
felt through the M-Port.
Syringe with Luer cone
Remove the M-Port cap. Mount the syringe in the M-Port and lock it by turning
it ¼ turn clockwise. Inject drug into the M-Port. Ventilate 5-10 times quickly
in succession.
Remove the empty syringe, and replace the M-Port cap.
Syringe with needle
Insert the needle into the middle of the M-Port cap. Inject drug into the
M-Port.
Ventilate 5-10 times quickly in succession. Remove the empty syringe.
5.5 Demand valve connector 5
The Adult and Paediatric resuscitator are available as demand valve versions
equipped with an inlet valve that connects to a demand valve. In order to
attach the demand valve pull the oxygen reservoir out of the inlet valve. The
demand valve can afterwards be inserted into the inlet valve.
Oxygen administration
Administer oxygen according to medical indication.
Examples of O2 percentages which can be obtained with different volumes and
frequencies have been calculated. The O2 percentages can be seen in 6 Adult
(6.1), Pediatric (6.2), Infant (6.3).
VT: Ventilation volume, f: Frequency
Note: If high ventilation pressures are used, higher O2 flow settings are
needed because part of the stroke volume is vented from the pressure-limiting
valve.
For infant version, use of supplementary oxygen without reservoir attached
will limit the oxygen concentration to 60-80% at 15 liters of O2/min.
Test of function 7
Resuscitator
Close the pressure-limiting valve with the overwrite cap (This only applies to
the version with pressure limiting valve) and close the patient connector with
the thumb (7.1). Briskly squeeze the bag. The resuscitator shall offer
resistance to the squeeze.
Open the pressure-limiting valve by opening the override cap or by removing
the finger and repeating the procedure. The pressure limiting valve should
now be activated and
it should be possible to ear the expiratory flow from the valve.
Squeeze and release the resuscitator a few times to ensure that air is moving
through the valve system and out of the patient valve. (7.2)
Note: As the valve plates are moving during functional test or during
ventilation a slight sound may appear. This does not compromise the
functionality of the resuscitator.
Oxygen reservoir bag
Supply a gas flow of 5 l/min to the oxygen bag. Check that the reservoir
fills.
If not, check the integrity of the two valve shutters or for a torn reservoir.
Oxygen reservoir tube
Supply a gas flow of 10 l/min to the oxygen tube. Check that the oxygen flows
out at the end of the reservoir tube. If not, check for a blocked oxygen tube.
M-Port
Remove the M-Port cap and block the patient connector. Squeeze the bag and
listen for the sound of air being pressed out through the M-Port. (7.3)
Accessories
Ambu disposable PEEP valve item no. 199102001
For further information please refer to the directions for use of the Ambu
PEEP valve. (8.1)
To fit the Ambu PEEP valve (if required) to the resuscitator remove the outlet
cap. (8.2)
Ambu Disposable Pressure Manometer (8.3) item no. 322003000
For further information please refer to the directions for use of the Ambu
Disposable Pressure Manometer.
CAUTION
If applicable, please see accessory packaging for more specific information
about the individual accessory e.g. expiration date, and MR Conditional.
Ambu A/S
Baltorpbakken 13
DK-2750 Ballerup
Denmark
T +45 7225 2000
F +45 7225 2050
www.ambu.com