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Section 12

Regulatory Information

Section 12 - Regulatory Information

Symbols:

Serious Incidents:

Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the

competent authority of the Member state in which the user and/or patient is established.

CE Marking of Conformity

Authorized Representative

in the European Community

Catalogue Number

Serial Number

Consult Instructions for use

Medical Device

Manufacturer

Date of Manufacture

Unique Device Identifier

Содержание BabyPod 2

Страница 1: ...Operating and Maintenance Manual Infant Transport Device ...

Страница 2: ...6 9 Section 7 Section 8 Section 9 Section 10 Section 11 Section 12 Section 13 General warnings and cautions Introduction Warnings Cautions Indications for use Product description Indications Components Accessories Getting to know BabyPod 2 Product diagram Product components and descriptions Environmental conditions Safety inspection of BabyPod 2 Unpacking BabyPod Inspecting BabyPod Re assembly of ...

Страница 3: ...xing Straps prior to transport with BabyPod 2 Strap buckles make an audible click when fully engaged DO NOT modify or make additions to any part of BabyPod 2 Only BabyPod 2 parts and accessories available through customer services and authorised representatives should be used to replace any components or accessories Use only non abrasive cleansers to clean BabyPod 2 Abrasive cleaners may damage th...

Страница 4: ...medical facility BabyPod 2 is designed to provide safe conveyance of a patient whose weight does not exceed 17 5 lbs 8 kg BabyPod 2 has been designed to exceed the standard CEN 1789 10g in six directions Section 2 3 Components Part Number Component Description BP2 001 BabyPod 2 Infant Transport Device BPOD2 002 Vacuum Mattress BP2 002 BPOD2 003 Infant Positioning Strap Set BP2 003 BP2 005 Shock Ab...

Страница 5: ...ion 3 1 Product diagram Section 3 Getting to know BabyPod 2 Front End Section Rear End Section Viewing Lid Tubing Access Ports Co2 Evacuation Inlet Access Port Lid Closing Turn Knob Viewing Lid Hinge End Stretcher Fixing Anchor Side Stretcher Fixing Anchors ...

Страница 6: ...raps BabyPod Infant Positioning Straps are manufactured from bands of soft foam which are attached using a hook and loop system Each set is SINGLE PATIENT USE ONLY BabyPods contains one set of 4 Infant Positioning Straps 2 straps with pre stitched hook tabs at each end and 2 straps with pre stitched hook tab at one end only Stretcher Fixing Straps The Stretcher Fixing Straps come in a set of two S...

Страница 7: ...han 28 0 degrees Celsius DO NOT place a baby directly on the printed side of the TransWarmer mattress An infant should be placed on TransWarmer s soft non woven surface Secure BabyPod 2 to a stretcher or gurney when possible BabyPod 2 may be hand carried if no stretcher or gurney is available e g Search and Rescue recovery If BabyPod 2 is to be used in the absence of a stretcher or gurney attach o...

Страница 8: ...d to the straps DO NOT use any component that does not pass visual inspection 7 Remove Vacuum Mattress from BabyPod 2 Inspect the mattress for holes or other obvious flaws 8 Remove Shock Absorbent Foam interior Inspect covers for any cuts or abrasions Lay foam aside for re assembly later 9 Inspect Outer Shell for cracks or abrasions First inspect the inner carbon fibre surface of BabyPod 2 s Outer...

Страница 9: ...ssembly of BabyPod 2 Once BabyPod 2 has been thoroughly inspected and cleared for use the device must be re assembled Re assemble BabyPod 2 according to the following instructions Release the turn lock mechanism at both ends of BabyPod 2 and open both lid sections Place BabyPod 2 on a smooth surface for re assembly ...

Страница 10: ...erior of BabyPod 2 Attach the 4 Infant Positioning Straps one at each end of each interior locating rail using the pre stitched hook material sliding under the rail and back onto itself Insert the Side foam panels being sure to locate the end of each into the recesses in both the Front end and the Rear end sections already in place When foam is properly located secure Side foam to the BabyPod 2 in...

Страница 11: ...he feet of the baby will be recommended with the valve facing up The valve should be in the open position tubing sections fully engaged with the black O ring hidden from view to allow air to enter the mattress Spread the polystyrene bead contents of the mattress evenly by hand At this stage the Vacuum Mattress should be tested according to the instructions in Section 5 4 Once the Vacuum Mattress h...

Страница 12: ...nt Attach one End and two Side Stretcher Fixing Straps to BabyPod 2 Insert male latch into female anchor buckle Listen for the click to indicate a secure connection Carefully close Viewing Lid back over the BabyPod 2 and close turn knobs checking that the mechanism is fully engaged and the Viewing Lid secure BabyPod 2 is now ready for use ...

Страница 13: ...engage with the black O ring hidden from view to suction air from inside the mattress If operating properly the Vacuum Mattress should lose its mouldability and become stiff Once the Vacuum Mattress has been suctioned successfully depress grey tab on the Vacuum Mattress valve to close valve Check mattress to see that it does not re inflate but retains its moulded shape Re connect the valve section...

Страница 14: ... Feed the long portion of the End Stretcher Fixing Strap underneath the foot bar of the stretcher and back through the metal slider buckle Grasp the webbing and pull away from the slider buckle to tighten the strap Make sure that the End Strap is securely tightened around the stretcher foot bar Re check the security of all Stretcher Fixing Straps to ensure patient safety before transport Section 6...

Страница 15: ...il sales babypod com Section 6 4 Placing baby inside BabyPod 2 Place the baby in the BabyPod 2 with either head or feet in front end section of the BabyPod 2 The orientation of the baby shall be determined by the clinician based on the monitoring and medical aid requirements of the baby during transportation and the layout of the transport vehicle Place baby face up on the non woven surface of the...

Страница 16: ...aps may cause injury to the patient during transport Section 6 6 Securing baby inside BabyPod 2 Warning Patients may be harmed by the incorrect use of this device Warning Each set of Infant Positioning Straps are SINGLE PATIENT USE ONLY Section 6 5 Operating Vacuum Mattress Check to see that the Vacuum Mattress valve is at the baby s feet Valve should be open with the long and short tubing section...

Страница 17: ...redness or irritation while TransWarmer Infant Transport Mattress is in use Monitor infant s temperature while TransWarmer Infant Transport Mattress is in use To minimise heat loss during transport leave patient access port in Viewing Lid in the closed position during transport unless the baby requires active care Section 6 9 Removing baby from BabyPod 2 To remove baby from BabyPod 2 release the b...

Страница 18: ...rmance of the unit Even with normal use BabyPod 2 may eventually need to be refurbished Contact our Customer Service Department for further information on refurbishment of BabyPod 2 Inspect BabyPod 2 s Outer Shell for cracks and abrasions First inspect the inner carbon fibre surface of BabyPod 2 s Outer Shell Note Smoothness is not a requirement Natural irregularities in texture due to the manufac...

Страница 19: ...step safety inspection instructions and Section 5 4 for testing procedures Note Only genuine BabyPod 2 parts and accessories should be used to replace any components or accessories For replacement or additional parts contact our customer service department at Tel 44 0 1992 535933 Email sales babypod com Section 9 Storage of BabyPod 2 BabyPod 2 should be stored in its protective storage cover shown...

Страница 20: ...d 2 used outside prescribed environmental conditions DO NOT use the TransWarmer Mattress in ambient temperatures greater than 28 0 degrees Celsius 6 3 Visual damage to BabyPod 2 Outer Shell Damaged due to sharp objects or blunt force Inspect inside of carbon fibre Outer Shell for cracks replace if necessary 8 Buckle not fully engaged Inadequate connection Listen for audible click to engage fully 6...

Страница 21: ...t foam inner layer and has transparent shields for viewing the baby BabyPod 2 contains a patient positioning vacuum mattress stretcher fixing straps to secure the device for transport and safety straps to position the baby inside the device during transport Safety Inspection Steps Prior to operating BabyPod 2 1 Unpack BabyPod 2 2 Inspect BabyPod 2 3 Re assemble BabyPod 2 4 Test the Vacuum Mattress...

Страница 22: ...ccurred in relation to this device should be reported to the manufacturer and the competent authority of the Member state in which the user and or patient is established CE Marking of Conformity Authorized Representative in the European Community Catalogue Number Serial Number Consult Instructions for use Medical Device Manufacturer Date of Manufacture Unique Device Identifier ...

Страница 23: ...________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________...

Страница 24: ... Unit 6 The Mead Business Centre Mead Lane Hertford Herts SG13 7BJ UK Tel 44 0 1992 535933 Web www babypod com Advanced Healthcare Technologies s r o Koclerov 11 544 62 Vitezna Czech Republic AHT F 063 v1 1 04 22 BabyPod 2 Operating Maintenance Manual ...

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